JP2016221013A - Wound covering material - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a wound covering material for forming a wet environment necessary for growth of epidermal cells, preventing excessive diffusion of an exudate to surrounding of a wound surface, and capable of liquating a wound healing component and antibacterial component.SOLUTION: The wound covering material comprises a glass fiber nonwoven fabric and an absorption member, in which the glass fiber nonwoven fabric is formed of a glass comprising as a glass composition, BOand CaO, and comprises a first surface contacting a wound surface, and a second surface facing the first surface. The absorption member is formed to cover the second surface of the glass fiber nonwoven fabric, and has adhesion enabling the wound covering material to adhere to skin.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a wound dressing that exhibits an excellent healing effect on wound surfaces such as cuts, lacerations, contusions, burns, and pressure sores, and a method for producing the same.

  Conventionally, as a treatment for wounds, first, disinfection is performed, and then treatment for protecting the wound surface with gauze is performed. However, such treatment methods kill epidermal cells by disinfection. In addition, it has been found in recent years that the cells of the epidermis are difficult to proliferate when the wound surface is dried.

  So instead of performing treatment with antiseptic solution and gauze, plastic surgeons Natsuki et al. Proposed a treatment method that maintains a moist environment on the wound surface and promotes cell growth (moist wound healing). Widely used (Non-Patent Document 1). In such treatment methods, the material used to maintain the moist environment of the wound surface is called a wound dressing.

WO2011 / 085092

Future wound treatment Satoshi Natsui, Medical School (2003/08)

  In recent years, glass fibers for wound dressing materials have been developed that exhibit a wound healing effect and antibacterial properties when a glass component is eluted in the exudate (Patent Document 1). When this type of glass fiber for wound dressing is used for treatment, the periphery of the wound surface is covered and fixed with a bandage or surgical tape so that the glass fiber does not come off the wound surface after the glass fiber is attached to the wound surface. However, the glass fiber for wound covering is difficult to maintain a moist environment, and the exudate may diffuse to the surroundings without staying on the wound surface, and may cause damage such as inflammation to normal skin.

  The present invention has been made in view of the above circumstances, and forms a moist environment necessary for the proliferation of epidermal cells, prevents the spread of excessive exudate around the wound surface, and elutes wound healing and antibacterial components. The object is to provide a possible wound dressing.

The wound dressing of the present invention is a wound dressing having a glass fiber nonwoven fabric and an absorbent member, and the glass fiber nonwoven fabric is made of glass containing B ₂ O ₃ and CaO as a glass composition and is in contact with the wound surface. The absorbent member is formed so as to cover the second surface of the glass fiber nonwoven fabric and has adhesiveness capable of adhering to the skin. It is characterized by having. Here, the absorbent member having adhesiveness that can adhere to the skin may be a material having a pressure-sensitive adhesive layer formed on the surface, or a so-called self-adhesive type material in which the material itself has adhesiveness. There may be.

  In the wound dressing of the present invention having the above-described configuration, Ca (calcium) serving as a nutrient for epidermal cells and B (boron) having a bactericidal effect on bacteria are eluted from a glass fiber nonwoven fabric containing blood or exudate. It is possible to promote the wound healing process and impart bactericidal properties to prevent critical colonization and infection of the wound surface. In addition, since the glass fiber nonwoven fabric can be adhered and fixed to the skin with the absorbent member covered, it is easy to maintain a moist environment and the exudate can be prevented from diffusing into normal skin around the wound surface.

  In the present invention, the absorbent member is preferably a hydrocolloid composition or a hydrogel composition.

  Hydrocolloid compositions and hydrogel compositions have an effect of promoting the division and migration of epidermal cells by maintaining exudate flowing out from the wound surface and maintaining a moist environment. Therefore, if the said structure is employ | adopted, it will become possible to heal a wound at an early stage combined with the effect | action by Ca and B which elute from a glass fiber nonwoven fabric.

  In this invention, it is preferable that an absorption member has an adhesive layer.

  If the said structure is employ | adopted, it will become easy to obtain adhesive force sufficient to fix a glass fiber nonwoven fabric to skin.

In the present invention, the glass fiber nonwoven fabric, in mass% of oxide _{equivalent, SiO 2 0~70%, B 2} O 3 5~80%, preferably made of glass containing 1 to 50% CaO. Moreover, the glass fiber nonwoven fabric is a mass% in terms of oxide, and further contains MgO 0-20%, Na ₂ O 0-20%, K ₂ O 0-40%, P ₂ O ₅ 0-20%. It is preferable to become.

  If the said structure is employ | adopted, Ca and B which promote wound treatment can fully be supplied to a wound surface.

  In the present invention, glass fiber non-woven fabric is immersed in a simulated body fluid of 37 ml and 60 ml of simulated body fluid for 2 days with a specific gravity of 0.256 weight glass classified to a particle size of 300 to 500 μm and stirred once a day. In the dissolution test, the B concentration in the simulated body fluid is preferably 0.1 to 70 mM and the Ca concentration is preferably 3.8 to 12 mM.

  If the said structure is employ | adopted, Ca and B which promote wound treatment can fully be supplied to a wound surface.

  In this invention, it is preferable that the average fiber diameter of a glass fiber nonwoven fabric is 100 nm-10 micrometers.

In the present invention, the glass fiber nonwoven fabric is preferably made of glass having a liquidus viscosity of 10 ^0.3 dPa · s or more.

It is a schematic sectional drawing which shows one embodiment of this invention.

  Hereinafter, the wound dressing of the present invention will be described in detail.

In the wound dressing of the present invention, as shown in FIG. 1, one side of a glass fiber nonwoven fabric 1 is covered with an absorbent member 2.
(1) Glass fiber nonwoven fabric The glass fiber nonwoven fabric 1 has the 1st surface 1a which is a contact surface with a wound surface, and the 2nd surface 1b which is a contact surface with the absorption member 2. FIG.

The glass fiber nonwoven fabric 1 contains B ₂ O ₃ and CaO as glass components, and elutes Ca (calcium), which is a nutrient for epidermal cells, and B (boron), which has a bactericidal effect on bacteria. Below, the reason which prescribed | regulated the content as mentioned above about the composition of the glass which comprises the glass fiber nonwoven fabric 1 is demonstrated. In addition, in description of the containing range of each component,% display points out the mass%.

B ₂ O ₃ is a component that forms the skeleton in the glass network structure, but does not increase the melting temperature of glass like SiO ₂ but rather has a function of lowering the melting temperature. Moreover, it is a component which exhibits a bactericidal effect by eluting into blood or exudate. The preferred content of B ₂ O ₃ is 5-80%, 10-65%, 15-35%, 19-30%, especially 19-25%. If the content of B ₂ O ₃ is too small, it will not be possible to obtain bactericidal properties to prevent critical colonization of the wound surface and infection. Wound healing rate decreases working excessive sterilization effect when the content is too large relative to the wound surface of B ₂ O _3.

  CaO is a component that lowers the viscosity of glass, and is a component that exhibits an effect of promoting cell growth when eluted into blood or exudate. The preferred content of CaO is 1-50%, 5-40%, 10-35%, 15-30%, especially 15-25%. If the content of CaO is too small, it is difficult to obtain the effect of promoting cell growth. When there is too much content of CaO, liquidus temperature will become high, it will devitrify at the time of glass melting, and it will become difficult to obtain homogeneous glass.

Further in addition to _B 2 _{O 3} and _{CaO, SiO 2, MgO, Na} 2 O, preferably contains _{K 2} O and _P 2 _{O 5.}

Similar to B ₂ O ₃ , SiO ₂ is a main component that forms a glass skeleton structure. Moreover, it is a component which raises the viscosity of glass. Suitable content of SiO ₂ 0 to 70% 10-50%, 15% to 45%, 20-40%, in particular 30-40%. If the content of SiO ₂ is too large, the dissolution rate of glass into blood or exudate is reduced. In addition, the fiberizing temperature (temperature corresponding to a viscosity of 10 ^1.0 dPa · s) increases and the cost for fiberizing increases. If the content of SiO ₂ is too small, the viscosity of the glass is lowered, the liquid phase viscosity is remarkably lowered, and the amount of beads mixed increases when molded into glass fibers.

  MgO is a component having a function as a flux that makes it easy to melt glass raw materials, and at the same time, is very effective in lowering the melting temperature. It is a useful ingredient. A suitable content of MgO is 0 to 20%, 0 to 10%, especially 0.5 to 8%. If the MgO content is too high, the viscosity of the glass is lowered or the liquid phase viscosity is lowered. Therefore, when glass fibers are produced by a method such as a melt blow method, the amount of mixed beads increases.

Na ₂ O is a component that improves the meltability and moldability of the glass by reducing the viscosity of the glass. The preferred content of Na ₂ O is 0-20%, 1-15%, especially 2-10%. If the content of Na ₂ O is too large, the viscosity of the glass is lowered or the liquid phase viscosity is remarkably lowered. Therefore, when the glass fiber is produced by a method such as a melt blow method, the amount of mixed beads is increased. .

K ₂ O is a component that improves the meltability and moldability of the glass by reducing the viscosity of the glass. A suitable content of K ₂ O is 0 to 40%, 5 to 30%, 7 to 20%, in particular 7 to 15%. If the content of K ₂ O is too large, the glass viscosity will decrease or the liquid phase viscosity will be extremely low. Therefore, when glass fibers are produced by a method such as the melt blow method, the amount of mixed beads increases. To do.

P ₂ O ₅ is a component that vitrifies itself and constitutes the network of the glass. The suitable content of P ₂ O ₅ is 0 to 20%, 0 to 10%, particularly 0.1 to 5%. If the P ₂ O ₅ content is too high, the viscosity of the glass will decrease or the liquid phase viscosity will be significantly reduced. Therefore, when glass fibers are produced by a method such as the melt blow method, the amount of mixed beads increases. To do.

The above-mentioned component _{(SiO 2, B 2 O 3} , CaO, MgO, Na 2 O, K 2 O, P 2 O 5) may also contain other components. However, it is desirable to adjust the composition so that the total content of the above components is 98% or more, particularly 99% or more. The reason is that when the total amount of these components is less than 98%, the dissolution rate of the glass into the blood or exudate decreases due to unintentional mixing of different components. As a result, inconveniences such as deterioration in characteristics as a wound dressing and biocompatibility tend to occur.

  As components other than the above-described components, for example, to improve the bactericidal effect, Cu, Ag, Zn, Sr, Ba, Fe, F, Mo, Au, Mn, Sn, Ce, Cl, La, W, Nb, Y Etc. may be contained up to 2% in total.

  The glass fiber nonwoven fabric constituting the wound dressing of the present invention is obtained by immersing glass having a specific gravity of 0.256 weight divided to a particle size of 300 to 500 μm for 2 days in a simulated body fluid at 37 ° C. for 2 days. In a dissolution test in which stirring is performed for 1 day, it is preferable that the B concentration in the simulated body fluid is 0.1 to 70 mM and the Ca concentration is 3.8 to 12 mM. When the B concentration in the simulated body fluid by this dissolution test is less than 0.1 mM, it becomes difficult to obtain the bactericidal effect necessary as a wound dressing. On the other hand, when the B concentration is higher than 70 mM, the proliferation of the patient's own cells may be suppressed. On the other hand, when the Ca concentration is less than 3.8 mM, it is difficult to obtain the effect of cell proliferation necessary as a wound dressing. On the other hand, when the Ca concentration is higher than 12 mM, the effect of cell proliferation is difficult to sustain, and it is necessary to frequently replace the wound dressing.

  Moreover, in the wound dressing of this invention, it is preferable that the average fiber diameter of the glass fiber which comprises a cotton-like body is 100 nm-10 micrometers. Here, the “average fiber diameter of the glass fiber” refers to a length measuring function of the scanning electron microscope by taking a secondary electron image or a reflected electron image of the glass fiber using a scanning electron microscope (HITACHI s-3400N type II). The diameter of 50 glass fibers was measured by using and the average value was determined by the method of making the average fiber diameter.

In the glass composition for wound treatment of the present invention, the liquid phase viscosity is preferably 10 ^0.3 dPa · s or more. The liquid phase viscosity is preferably 10 ^0.4 dPa · s or more, more preferably 10 ^0.5 dPa · s or more, and further preferably 10 ^1.0 dPa · s or more. If the liquidus viscosity is too low, the amount of glass beads mixed in when the molten glass is fiberized to produce a cotton-like body increases. Here, the “liquid phase viscosity” refers to a viscosity derived from a viscosity curve by a method of measuring a viscosity at a crystal precipitation temperature (liquid phase temperature).

  The glass fiber nonwoven fabric constituting the wound dressing may be mixed with glass beads. In this case, the ratio of the glass beads in the glass fiber nonwoven fabric is preferably 50% or less, 40% or less, particularly 30% or less in mass%. If the proportion of glass beads increases too much, the specific surface area of the glass fiber nonwoven fabric decreases, so the dissolution rate of the glass decreases, making it difficult to sufficiently provide Ca or B to blood or exudate, The properties as a coating material are reduced. There is also a concern that glass beads may irritate the epidermis and cause inflammation and scar formation of the epidermis.

  The average diameter of the glass beads is preferably 500 μm or less, particularly preferably 100 μm or less. If the average diameter of the glass beads is too large, the specific surface area of the glass fiber nonwoven fabric will be small, so the dissolution rate of the glass will be reduced, and it will be difficult to sufficiently provide Ca or B to blood or exudate. The properties as a coating material are reduced. There is also a concern that glass beads may irritate the epidermis and cause inflammation and scar formation of the epidermis.

In addition, the glass fiber nonwoven fabric of this invention may contain the glass body of various shapes, such as a powder form and flake form other than glass fiber and a glass bead. Moreover, various chemical | medical agents can also be added and impregnated in the glass fiber nonwoven fabric.
(2) Absorbing member The absorbing member 2 is a member that absorbs and retains appropriate moisture. In addition, by adhering to the skin around the wound surface, it functions to isolate the wound surface from the surrounding normal skin.

  The absorbent member 2 has a glass fiber nonwoven fabric and a first surface 2a on the skin side and a second surface 2b on the outside air side. The 2nd surface of the absorption member 2 has the adhesiveness which can adhere | attach with the glass fiber nonwoven fabric 1 and skin. In addition, it is preferable that the absorption member 2 has moderate flexibility. When the absorbing member 2 has appropriate flexibility, it can be attached to a bent portion such as a heel.

  By adopting such an absorbent member, the wound surface is maintained in a good moist environment, while the normal skin around the wound surface is in a dry state, and damage due to wetting to the normal skin can be minimized. .

  As the absorbent member 2, it is preferable to use a hydrocolloid composition or a hydrogel composition. In addition to these, it is also possible to use a nonwoven fabric made of a polymer or the like.

  Examples of the hydrocolloid composition include carboxymethyl cellulose, carboxymethyl starch, their 40 alkali metal derivatives, alginate, polyvinyl alcohol, polyvinyl pyrrolidone, carrageenan, gelatin, pectin, guar gum, gum arabic, locust bean gum and karaya. It is preferable to contain at least one hygroscopic polymer selected. Furthermore, it is preferable that the hydrocolloid composition is blended with the elastomer. Such an elastomer is at least one selected from the group consisting of polyisobutylene, polyisoprene, butyl rubber, styrene / isoprene / block copolymer, sucrose acetate isobutyrate, acrylic elastomer, urethane elastomer and silicone elastomer. It preferably contains an elastomer component.

  The hydrogel composition preferably contains at least one of, for example, polyvinyl alcohol or polyvinyl pyrrolidone.

  The absorbent member 2 preferably has an acrylic or rubber-based hydrophobic pressure-sensitive adhesive layer on the second surface 2b side in order to ensure adhesion to the glass fiber nonwoven fabric 1 and the skin.

  The thickness of the absorbent member 2 is 30 to 150 μm, preferably about 50 to 100 μm. If the thickness of the absorbent member is in the above range, a wound dressing that does not impair flexibility and suppresses a sense of incongruity at the time of application can be obtained.

The absorbent member 2 can contain a small amount of a pharmacologically active ingredient for promoting wound healing. For example, in hydrocolloid compositions, antibiotics (eg chlorhexidine gluconate, benzalkonium chloride, benzenium chloride, sulfa drugs) or disinfectants (eg popidone, iodine), anti-inflammatory agents (eg hydrocortisone, triamcinolone acetonide), skin protectants (For example, zinc oxide) etc. can be mix | blended.
(3) Moisture-impermeable layer In the present invention, a moisture-impermeable layer may be further provided on the outside air side of the absorbent member 2 as necessary. As the moisture impermeable layer, for example, a film containing at least one selected from the group consisting of polyvinyl chloride, polyethylene, polyolefin, polyurethane, polypropylene, polyisobutylene, and polyisoprene can be used.
(4) Manufacturing method of wound dressing material Next, the manufacturing method of the wound dressing material of this invention is demonstrated. However, the method for producing the wound dressing of the present invention is not limited to this.

  First, the prepared glass raw material batch is put into a glass melting furnace, vitrified, melted and homogenized. Next, the molten glass is supplied to a nozzle member made of noble metal equipped with a discharge nozzle, and the molten glass flows down from the nozzle member by a so-called melt blow method in which high-speed air is blown from the side, both sides, or the entire circumference of the discharge nozzle. Fiberize. Subsequently, the fiberized glass is continuously deposited on the conveyor having a metal net so as to have a uniform thickness, and then adjusted to a desired thickness with a rolling roller. Thus, the glass fiber nonwoven fabric 1 can be obtained. In addition to the above, glass fiberization is performed by, for example, applying a high voltage between a glass discharge nozzle and a target electrode disposed so as to face the nozzle member, and using charged molten glass discharged from the discharge nozzle as an electrode member. So-called electrospinning, which is formed into a fiber while drawing toward the side, or molten glass is flowed down from the fore hearth and introduced into a spinner (rotary body), and this spinner is rotated at a high speed to produce fibers from an orifice provided on the side wall of the spinner It is also possible to employ a so-called centrifugal method for discharging glass-like glass.

  Moreover, the absorption member 2 is prepared.

  Subsequently, the absorbent member 2 is bonded to the glass fiber nonwoven fabric 1 so as to cover the first surface 1b of the glass fiber nonwoven fabric 1, thereby obtaining a wound dressing. Furthermore, you may form a water-impermeable layer by the method of sticking a water-impermeable film on the absorption member 2 as needed.

  Even if the wound dressing of the present invention produced by the above steps is a wound surface with a large amount of exudate, excessive exudate does not diffuse around the wound surface. In addition, a moist environment necessary for the growth of epidermal cells is formed on the wound surface. Furthermore, the wound healing process is promoted by eluting a component that promotes wound healing and a component having antibacterial properties from the glass fiber nonwoven fabric, and exhibits bactericidal properties to prevent critical colonization and infection of bacteria on the wound surface.

Hereinafter, based on an Example, this invention is demonstrated in detail.
(1) Production of glass nonwoven fabric

  Table 1 has shown the composition example (sample No. 1-5) of the glass nonwoven fabric used by this invention.

  First, various glass raw materials, such as a natural raw material and a chemical raw material, were weighed and mixed so that it might become the glass composition of Table 1, and the glass batch was produced. Next, after putting this glass batch into a crucible made of platinum rhodium alloy, it was heated at 1200 to 1550 ° C. for 4 hours in an indirect heating electric furnace to obtain a molten glass. In order to obtain a homogeneous molten glass, the molten glass was stirred a plurality of times using a heat-resistant stirring rod during heating. Subsequently, the obtained molten glass was poured into a refractory mold and allowed to cool in air to obtain a massive glass sample. About each obtained sample, the elution test in a pseudo body fluid and the liquid phase viscosity of glass were measured. The results are shown in Table 1.

  The dissolution test was measured as follows. First, a massive glass sample is pulverized, glass having a particle size of 300 to 500 μm is precisely weighed by the specific gravity × 0.256, and then 60 ml of a simulated body fluid is placed in a polypropylene container (PP container) having a capacity of 100 ml. A glass sample was immersed, and an elution test was performed at 37 ° C. for 2 days. At that time, stirring was performed once / day. Stirring was performed by shaking the PP container by hand several times. The test solution was filtered after the dissolution test, and the B and Ca concentrations in the eluate were quantified using ICP-OES.

  The liquid phase viscosity was measured as follows.

  First, a massive glass sample was pulverized, adjusted to have a particle size in the range of 300 to 500 μm, and filled in a fire-resistant container so as to have an appropriate bulk density. Next, this refractory container was placed in an indirect heating type temperature gradient furnace and left to stand for 16 hours in an air atmosphere. Subsequently, after taking out the specimen together with the refractory container from the temperature gradient furnace and cooling it to room temperature, the crystal precipitation location was determined by an optical microscope, and the crystal precipitation temperature ( Liquid phase temperature).

  Furthermore, the massive glass sample is crushed to an appropriate size, put into an alumina crucible so that bubbles are not caught as much as possible, and then the alumina crucible is heated to bring the sample into a molten state. A measured value of the viscosity of the glass at temperature was obtained, and a constant of the Vogel-Fulcher formula was calculated to create a viscosity curve. The viscosity at the liquidus temperature was determined from the viscosity curve thus obtained, and this was used as the measured value of the liquidus viscosity.

Next, a blocky glass sample was put into a noble metal pot equipped with a glass discharge nozzle, and the glass sample was remelted by energization heating. Thereafter, high-speed air was blown onto the glass flowing down from the discharge nozzle, and the molten glass was drawn into fibers and continuously deposited on the conveyor having a metal net so as to have a uniform thickness. This glass fiber was laid on a horizontal table, and formed into a nonwoven fabric having a thickness of 1.0 to 2.0 mm using a roller.
(2) Production of wound dressings Wound dressings of Examples 1 and 2 were produced using the glass fiber nonwoven fabric produced as described above.
[Example 1]
A hydrocolloid composition containing carboxymethyl cellulose as a hygroscopic polymer and polyisobutylene as an elastomer component and having an acrylic pressure-sensitive adhesive layer was prepared. Next, on the pressure-sensitive adhesive layer of the prepared hydrocolloid composition, No. 1 in Table 1 was obtained. A glass fiber nonwoven fabric made of 1 glass was laminated to obtain a wound dressing.
[Example 2]
An aqueous solution containing 20% polyvinyl alcohol and 4% glycerin was applied on the peeled process paper, and a 40 kGy electron beam was irradiated on the film to prepare a hydrogel composition. Next, an acrylic pressure-sensitive adhesive layer was formed on one side of the hydrogel composition. Next, No. 1 in Table 1 was formed on the acrylic pressure-sensitive adhesive layer. A glass fiber nonwoven fabric made of 2 glass was laminated to obtain a wound dressing.

1 Glass fiber nonwoven fabric 2 Absorbing member

Claims (8)

A wound dressing having a glass fiber nonwoven fabric and an absorbent member,
The glass fiber nonwoven fabric is made of glass containing B ₂ O ₃ and CaO as a glass composition, and has a first surface in contact with the wound surface and a second surface facing the first surface,
The wound dressing material, wherein the absorbent member is formed so as to cover the second surface of the glass fiber nonwoven fabric and has adhesiveness capable of adhering to the skin.   The wound dressing according to claim 1, wherein the absorbent member is a hydrocolloid composition or a hydrogel composition.   The wound dressing according to claim 1 or 2, wherein the absorbent member has an adhesive layer. Glass fiber nonwoven fabric, in mass percent on the oxide _basis, claim, characterized in that it consists of glass containing _{SiO 2 0~70%, B 2 O} 3 5~80%, the 1 to 50% CaO 1 to 3 The wound dressing according to any one of the above. The glass fiber nonwoven fabric is made of glass containing, in terms of oxide% by mass, MgO 0-20%, Na ₂ O 0-20%, K ₂ O 0-40%, P ₂ O ₅ 0-20%. The wound dressing according to claim 4.   Dissolution test in which glass fiber nonwoven fabric was soaked in a simulated body fluid of 37 ° C and 60 ml of simulated body fluid for 2 days after the glass having a specific gravity of 0.256, which was classified to a particle size of 300 to 500 µm, was stirred for 2 days. The wound dressing according to any one of claims 1 to 5, wherein the B concentration in the simulated body fluid is 0.1 to 70 mM and the Ca concentration is 3.8 to 12 mM.   The wound dressing according to any one of claims 1 to 6, wherein the glass fiber nonwoven fabric has an average fiber diameter of 100 nm to 10 µm. The wound dressing according to any one of claims 1 to 7, wherein the glass fiber nonwoven fabric is made of glass having a liquidus viscosity of 10 ^0.3 dPa · s or more.