WO2015096543A1 - 含有三层织物的伤口敷料及其制备方法 - Google Patents

含有三层织物的伤口敷料及其制备方法 Download PDF

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Publication number
WO2015096543A1
WO2015096543A1 PCT/CN2014/089318 CN2014089318W WO2015096543A1 WO 2015096543 A1 WO2015096543 A1 WO 2015096543A1 CN 2014089318 W CN2014089318 W CN 2014089318W WO 2015096543 A1 WO2015096543 A1 WO 2015096543A1
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Prior art keywords
fabric
fiber
layer
layer fabric
wound dressing
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PCT/CN2014/089318
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English (en)
French (fr)
Inventor
王晓东
莫小慧
冯彩霞
萧健鹏
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佛山市优特医疗科技有限公司
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Priority to EP14874202.6A priority Critical patent/EP3087960B1/en
Publication of WO2015096543A1 publication Critical patent/WO2015096543A1/zh
Priority to US15/191,508 priority patent/US10342707B2/en

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    • A61F13/00—Bandages or dressings; Absorbent pads
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    • A61F13/023—Adhesive bandages or dressings wound covering film layers without a fluid retention layer
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    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01021—Non-adhesive bandages or dressings characterised by the structure of the dressing
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    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
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    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
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    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
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    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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    • A61L2300/412—Tissue-regenerating or healing or proliferative agents

Definitions

  • the invention relates to a wound dressing comprising three layers of fabric and a preparation method thereof.
  • wound dressings with high moisture absorption, especially fiber-based wound dressings, which are composed of fibers with sol properties, such as calcium alginate wound dressings and shells.
  • fiber-based wound dressings which are composed of fibers with sol properties, such as calcium alginate wound dressings and shells.
  • Sugar wound dressings, modified cellulose wound dressings, and the like are characterized by high hygroscopicity and moisture retention, which form a gel after absorbing wound exudate, providing a relatively moist environment for wound healing.
  • high hygroscopic fibrous wound dressings on the market in addition to single component fiber dressings, also have multicomponent fiber dressings prepared by mixing various component fibers, such as in sol fibers.
  • the non-sol fiber is blended and blended, and the obtained dressing has both high moisture absorption performance and certain wet strength.
  • a fiber dressing obtained by blending a gellable fiber such as alginate fiber with a conventional non-gel fiber such as cellulose fiber is disclosed in European Patent No. EP 0 740 554 and US Pat.
  • Another wound dressing which is a mixture of two sol fibers, one of which is a carboxymethylcellulose fiber and the other is alginate fiber to promote moisture absorption and is disclosed in US Pat. No. 6,458,460 and European Patent No. 09,270,313. The best effect of absorbing wound exudate is achieved.
  • U.S. Patent No. 7,385,101 discloses a wound dressing blended with silver plated nylon fibers and hygroscopic fibers, the dressing containing an antibacterial agent silver which can be used to treat wounds.
  • the above-mentioned dressings obtained by mixing a plurality of fibers have certain comprehensive properties such as high absorbency, high wet strength, antibacterial property, etc., but the structure of the dressing is prepared by uniformly mixing two or more kinds of fibers.
  • the dressing usually has only one bulk density, and the water lock is poor; and the part of the dressing and the wound is still a fibrous structure.
  • part of the fiber debris is likely to remain on the wound, thereby causing adhesion. Flushing the wound with a large amount of saline increases the pain of the patient and increases the workload of the caregiver.
  • the dressing in addition to preparing the dressing by the fiber blending process, it can also be prepared by A multi-layered dressing provides a dressing with a certain overall performance or specific function.
  • European Patent No. EP0575090B1 discloses a product which can absorb wound exudate, which product contains alginate, which may be in the form of granules, flakes, spheres, etc. and is contained in a porous ethylene/methacrylate.
  • the bags are connected by a string; the other form of the product is a spherical alginate directly connected by a string, and a cylindrical bag with a hole is placed on the outside.
  • the wound exudate passes through the holes in the bag and is absorbed by the alginate in the bag, thereby achieving the purpose of absorbing the wound exudate.
  • European Patent EP 0 788 378 B1 discloses a three-layer wound dressing, the first layer of material (such as calcium alginate and its derivatives, chitosan and its derivatives, etc.) can effectively promote wound healing, the second layer
  • the material comprises a fibrous woven fabric, a nonwoven fabric or a knitted fabric having a hydrophilicity better than the first layer material, and the third layer material is a gas permeable film such as polyurethane for fixing the dressing to the wound, but There is still a problem of fiber residue and poor moisturizing performance when the dressing is changed.
  • Patent WO2010/109239A1 and Chinese patent CN102481208A disclose a wound dressing of a layered composition consisting of three layers of material, the first layer being a gel material, such as a hydrogel or a hydrocolloid; the second layer of material hardness It is larger than the first layer material, such as polyester; the third layer material has a tensile modulus smaller than that of the second layer material, such as a low friction material.
  • the dressing is comfortable and flexible, absorbs and selectively retains the wound exudate, helps keep the wound moist, and can be used for the care of acute or chronic wounds.
  • the dressing used a hydrogel material without the softness of the fibrous dressing.
  • U.S. Patent No. 2011/0280926A1 and Chinese Patent No. CN102076291A disclose a multilayer wound dressing comprising a wound contact layer and an absorbent layer, the absorbent layer comprising a hydrophilic polyurethane foaming material for use in the treatment of wounds.
  • the dressing used a polyurethane material without the softness of the fibrous dressing.
  • Patent WO2007/117237A1 and Chinese patent CN101460202A disclose an enhanced absorbable multilayer hemostatic wound dressing comprising a first absorbable nonwoven fabric, a second absorbable woven fabric or knit, thrombin and / or fiber protein.
  • the dressings referred to in this patent do not have good moisturizing properties.
  • U.S. Patent No. 6,552,244 and European Patent No. 1,139,946 also disclose a multi-layered wound dressing.
  • the upper layer of the dressing is a layer of absorbent fibers with a layer of mesh-like moisture-conducting layer, such as a viscose mesh, the main features of the bottom layer. It has a certain ability to transmit steam.
  • the dressing The main function is to export the wound secretion as soon as possible, and its moisture absorption and moisturizing ability is still limited.
  • the present invention provides a wound dressing comprising a three-layer fabric comprising: a first outer layer fabric located on both outer surfaces of the wound dressing, a second outer layer fabric, and a first outer layer fabric, second An intermediate fibrous layer fabric between the outer layers of fabric; the first outer fabric and the second outer fabric have a bulk density greater than a bulk density of the intermediate fibrous layer fabric; the first outer fabric and the second outer fabric
  • the grammage is between 8-140 g/m2 and the bulk density is between 0.08-0.32 g/cm3; the grammage of the first outer fabric and the second outer fabric are preferably 10 - 100 g/m 2 and the bulk density is preferably between 0.08 and 0.25 g/cm 3 .
  • At least one of the first outer layer fabric and the second outer layer fabric is selected from the group consisting of alginate fiber fabric, chitosan fiber fabric, cellulose fiber fabric, carboxymethyl chitosan fiber fabric, acylation Chitosan fiber fabric, carboxymethyl cellulose fiber fabric, carboxyethyl cellulose fiber fabric, water-insoluble cellulose alkyl sulfonic acid fiber fabric, vinylon fabric, polypropylene fiber fabric, polyester fiber fabric, nylon fiber A woven fabric, a rayon fabric, or a blended fabric of two or more of the above fibers.
  • At least one of the first outer layer fabric and the second outer layer fabric contains an antibacterial agent, and the antibacterial agent content is between 0.01% and 25%, preferably between 0.1% and 20%;
  • the fibrous layer fabric fibers contain an antibacterial agent in an amount of from 0.01% to 20%, preferably from 0.1% to 10%; the antibacterial agent is preferably silver.
  • first outer layer fabric and the second outer layer fabric is a knitted fabric, a woven fabric or a non-woven fabric; the intermediate fibrous layer fabric is a nonwoven fabric; the knitted fabric and the woven fabric Woven from staple fiber yarn or woven from filament yarn, staple fiber yarn
  • the linear density or filament density is between 0.5 and 10.0 dtex, preferably between 1 and 6 dtex.
  • the intermediate fiber layer fabric comprises alginate fiber, chitosan fiber, cellulose fiber, carboxymethyl chitosan fiber, acylated chitosan fiber, carboxymethyl cellulose fiber, carboxyethyl fiber Plain fiber, water-insoluble cellulose alkyl sulfonate fiber, bicomponent fiber, vinylon fiber, polypropylene fiber, polyester fiber, nylon fiber, acrylic fiber, crosslinked acrylic fiber, wood pulp fiber or the above two or two A fiber blended with the above fibers.
  • the intermediate fibrous layer fabric has a basis weight of between 60 and 600 grams per square meter, preferably between 80 and 500 grams per square meter, more preferably between 100 and 400 grams per square meter.
  • the intermediate fiber layer woven fabric fibers have a linear density of between 0.5 and 10.0 dtex, preferably between 1 and 6 dtex; the fiber length is between 3 and 150 mm, preferably between 5 and 75 mm. between.
  • the nonwoven fabric is formed by a needle punching, a spunlace cloth, a heat fusion cloth or a chemical bonding cloth.
  • the first outer fabric and the second outer fabric and the intermediate fiber layer fabric are composited by needle punching, hot melt bonding, chemical bonding or ultrasonic welding; composite in hot melt or ultrasonic welding
  • the pattern has a pattern, which is a square, a triangle, a rectangle, a diamond, a circle or a dot.
  • the present invention also provides a preparation method for preparing the above three-layered wound dressing comprising: A) providing an original processed material for preparation, that is, the first outer fabric and the second outer fabric and The fibrous material of the intermediate fiber layer fabric, and measuring various parameters of the material; B) processing the fiber material to form a fiber web; C) processing the fiber web into an intermediate fiber layer fabric; D) fabricating the intermediate fiber layer fabric Composite processing with the first outer fabric and the second outer fabric to obtain a composite fabric; E) sterilizing the composite fabric to obtain a three-layer fabric wound dressing.
  • the wound dressing of the present invention comprises a first outer layer fabric and a second outer layer fabric and an intermediate fiber layer fabric, wherein the intermediate fiber layer fabric has a small bulk density and a fluffy structure, and the wound secretion is more easily retained in the fabric structure. .
  • the wound exudate absorbed into the intermediate fiber layer can be well locked to prevent the exudate from flowing back to the wound to cause secondary infection of the wound.
  • the dressing has a three-layer structure, and the bulk density of the first outer fabric and the second outer fabric is greater than the bulk density of the intermediate fiber layer, the strength of the dressing, especially the wet strength, is improved, and therefore, the dressing is changed. When the dressing is not easily broken, it can be removed in one piece without any fiber debris falling off.
  • Example 1 is a photograph of a zone of inhibition of a wound dressing of Example 2 of the present invention after one day in a Staphylococcus aureus culture dish.
  • Example 2 is a photograph of a zone of inhibition of a wound dressing of Example 5 of the present invention after one day in a P. aeruginosa culture dish.
  • Figure 3 is a schematic view of the structure of the present invention.
  • Figure 4 is a flow chart of the preparation method of the present invention.
  • the present invention provides a wound dressing comprising a three-layer fabric and a method of preparing the same.
  • the three-layer fabric-containing wound dressing of the present invention comprises three layers of fabric, as shown in Figure 3, wherein the first layer of fabric is the first outer layer fabric 1, the second layer of fabric is the intermediate fiber layer fabric 2, and the third layer of fabric is Second outer layer fabric 3.
  • the first outer layer fabric 1, the second outer layer fabric 3 are located on the two outer surfaces of the wound dressing, and the intermediate fiber layer fabric 2 is located between the first outer layer fabric 1 and the second outer layer fabric 3.
  • the bulk density of the first outer layer fabric and the second outer layer fabric are both greater than the bulk density of the intermediate layer fabric of the second layer.
  • the first outer fabric and the second outer fabric each have a basis weight of between 8 and 140 g/m 2 , preferably between 10 and 100 g/m 2 ; and the bulk density is between 0.08 and 0.32 g/cm 3 . Between, preferably between 0.08 and 0.25 g/cc.
  • the first outer layer fabric and the second outer layer fabric may each be selected from alginate fiber fabric, or chitosan fiber fabric, or cellulose fiber fabric, or modified chitosan fiber fabric.
  • a modified cellulose fiber fabric which may also be a vinylon fiber fabric, or a polypropylene fiber fabric, or a polyester fiber fabric, or a nylon fiber fabric, or an acrylic fiber fabric, or a blend fabric of the above two or more fibers.
  • first outer fabric and the second outer fabric may be the same fabric, or may be any two of the above fabrics, that is, the structure of the three-layer fabric dressing may be symmetrical (the first outer fabric and The second outer fabric is the same) and may also be asymmetrical (the first outer fabric and the second outer fabric are different).
  • the alginate fiber is a high mannuronic acid (M) type, a high guluronic acid (G) type or a mannuronic acid/guluronic acid (M/G) mixed type.
  • the alginate fiber is calcium alginate fiber or calcium alginate/sodium fiber.
  • the chitosan fiber may be a chitosan fiber having a degree of deacetylation of 80% or more.
  • the modified chitosan fiber may be a carboxymethyl chemically modified carboxymethyl chitosan fiber or an acylated modified acylated chitosan fiber to improve its absorption performance, and its The absorption rate is 500% or more.
  • the cellulose fibers may be conventional viscose fibers or solvent-spun cellulose fibers such as Lyocell fibers.
  • the modified cellulose fiber may be a chemically modified carboxymethyl cellulose fiber, a carboxyethyl cellulose fiber or a water-insoluble cellulose alkyl sulfonic acid fiber, which has an absorption rate of 500% for distilled water or the above.
  • first outer fabric and the second outer fabric contain an antibacterial agent such as silver, PHMB or honey, of which silver or other silver-containing material such as a silver compound and a silver complex are preferred.
  • silver may be added to the inside or the surface of the fiber and then prepared into a fabric, or silver may be added directly inside or on the surface of the fabric.
  • the silver-containing fabric has a silver content of from 0.01% to 25%, preferably from 0.1% to 20%.
  • the invention does not limit the method of adding silver to the fiber, and the method for adding silver mainly comprises:
  • an antibacterial agent such as silver nitrate, silver chloride, silver carbonate or silver Sodium Zirconium Hydrogen phosphate to the spinning solution, so that the finished fiber contains an antibacterial agent
  • first outer layer fabric and the second outer layer fabric layer are knitted fabrics, woven fabrics or non-woven fabrics, and the knitted fabrics are fabrics prepared by a knitting process, the woven fabrics It is a fabric prepared by a weaving process, which is a fabric obtained by a nonwoven process.
  • the fabric may be woven from staple fiber yarn, that is, a fabric prepared by a process such as short-staple spinning, or may be woven from a long yarn, and the fiber or filament may be The density is between 0.5 and 10 dtex. Preferably between 1-6 dtex.
  • a nonwoven fabric it may be formed into a cloth by needle punching, a spunlace cloth, a heat-melt cloth or a chemically bonded cloth. Spunlaced cloth and hot-melt cloth are only suitable for some specific fibers. For example, spunlaced cloth is suitable for non-gel fiber, and hot-melt cloth is suitable for melt-spun fiber. More commonly, spunbonded nonwoven fabric.
  • the intermediate fiber layer fabric may contain alginate fiber, chitosan fiber, viscose cellulose fiber, lyocell cellulose fiber, carboxymethyl chitosan fiber, acylated chitosan fiber, carboxymethyl fiber.
  • the cross-linked acrylate copolymer fibre or the wood pulp fiber, that is, the fiber of the intermediate fiber layer fabric may be one of the above various fibers.
  • the intermediate fiber layer fabric of the present invention can also be used to prepare a dressing having a comprehensive function by fiber blending.
  • the fibers of the intermediate fiber layer fabric may be a combination of two or more kinds of fibers: alginate fiber, chitosan fiber, viscose cellulose fiber, and lyse Cellulose fiber, carboxymethyl chitosan fiber, acylated chitosan fiber, carboxymethyl cellulose fiber, carboxyethyl cellulose fiber, water-insoluble cellulose alkyl sulfonic acid fiber, low-component two-component Melting point fiber, vinylon fiber, polypropylene fiber, polyester fiber, nylon fiber, acrylic fiber, cross-linked acrylate copolymer fiber, and wood pulp fiber.
  • the calcium alginate fiber is blended with chitosan fiber, and the prepared dressing has hygroscopicity and also has the hemostatic function of chitosan.
  • the calcium alginate fibers may also be blended with carboxymethyl cellulose fibers.
  • the modified cellulose fibers may also be blended with unmodified cellulose fibers such as Lyocell.
  • the above intermediate fiber layer fabric may contain an antibacterial agent, which may be silver, PHMB or honey, etc., preferably silver ions, silver compounds, silver complexes or in fibers or
  • an antibacterial agent which may be silver, PHMB or honey, etc., preferably silver ions, silver compounds, silver complexes or in fibers or
  • the surface of the fabric is silver plated and has an antibacterial agent content of between 0.01% and 20%, preferably between 0.1% and 10%.
  • the intermediate fibrous layer fabric of the dressing of the invention has a basis weight of between 60 and 600 grams per square meter, preferably between 80 and 500 grams per square meter, more preferably between 100 and 400 grams per square meter.
  • the fibers of the intermediate layer fiber layer fabric used in the present invention are short fibers, and the filaments or fibers can be cut into a certain length according to the structure and production process of the wound dressing, and the fiber length is between 3 and 150 mm, preferably at 5 -75 mm between. And the fibers have a linear density, the fibers having a linear density of from 0.5 to 10 dtex, preferably between 1 and 6 dtex.
  • the intermediate fiber layer fabric is a nonwoven fabric which can be produced by a needle punching nonwoven process.
  • the cloth forming method may be a needle punching into a cloth, a heat fusion into a cloth or a chemical bonding into a cloth.
  • the composite of the first outer layer fabric and the second outer layer fabric and the intermediate fiber layer fabric may be achieved by a needle punching method, a hot melt method, an ultrasonic welding method or a chemical bonding method.
  • Acupuncture and chemical bonding are simple and easy to implement and can be applied to all fibers.
  • Hot melt and ultrasonic welding are only suitable for those with intermediate fabrics containing bicomponent fibers (eg polyethylene/polypropylene, etc.) or melt spinning. fiber.
  • the needle-punched composite dressing is soft to the touch, while the chemically bonded composite dressing feels harder.
  • the hot melt method and the ultrasonic welding method can form a pattern on the surface of the composite dressing by hot pressing and welding head. Common patterns are square, triangle, rectangle, diamond, circle or dot. These patterns sometimes prevent lateral diffusion of wound exudates, giving the dressing a lateral water retention capability.
  • the invention also provides a preparation method for preparing the above wound dressing containing three layers of fabric, the preparation method comprising:
  • the composite fabric package is sterilized to obtain a three layer fabric wound dressing.
  • the fabric was cut into squares or rectangles, and its weight G (gram) was measured, and then laid on a flat surface to measure the fabric length L (cm) and the fabric width W (cm).
  • the weight Gk is calculated by the following formula:
  • Gk is gram weight
  • G is the weight of the fabric
  • L is the length of the fabric
  • W is the width of the fabric
  • the fabric was placed flat between the presser feet of the thickness gauge, the presser foot diameter was 30 mm, and the pressure was 0.5 N when measured. After the presser foot is freely pressed against the fabric and the reading is stable, the fabric thickness D (mm) is read, and the thickness value D is accurate to 3 decimal places.
  • the bulk density P is calculated by the following formula:
  • P is the bulk density
  • G is the weight of the fabric
  • L is the length of the fabric
  • W is the width of the fabric
  • D is the thickness of the fabric.
  • Measurement of fiber length Measurement according to GB/T 14336-2008 chemical fiber/short fiber length test method.
  • wound dressing structural composition and corresponding preparation method of the present invention are described in detail below in conjunction with various specific embodiments. Materials and reagents used in the examples of the present invention are commercially available products unless otherwise stated.
  • the first outer layer fabric and the second outer layer fabric are prepared as a polypropylene fiber fabric, and the fiber of the intermediate fiber layer fabric is a wound dressing of MG type calcium alginate fiber.
  • Example 1 The specific preparation method of Example 1 is:
  • the first outer fabric and the second outer fabric are provided by a melt-spun polypropylene nonwoven fabric, the weight is 12 g/m 2 , the bulk density is 0.08 g/cm 3 , and the color is white;
  • the fiber of the intermediate fiber layer fabric is made of our own MG type calcium alginate fiber, the linear density of the fiber is 3.0 dtex, the fiber length is 75 mm, and the absorption rate of the solution A is above 1400%;
  • the intermediate fiber layer fabric has a basis weight of 99 g / square meter, a bulk density of 0.07 g / cm 3;
  • Example 2 the first outer layer fabric and the second outer layer fabric were prepared as a polypropylene fiber fabric, and the fibers of the intermediate fiber layer fabric were wound dressings containing silver carboxymethyl cellulose fibers.
  • Example 2 The specific preparation method of Example 2 is:
  • the first outer fabric and the second outer fabric are both melt spunbonded polypropylene nonwoven Cloth, weighing 12 g/m2, bulk density 0.08 g/cm3, color white;
  • the fiber of the intermediate fiber layer fabric is provided by the company's self-made silver-containing carboxymethyl cellulose fiber, the fiber linear density is 1.7 dtex, the fiber length is 50 mm, and contains 1.0% silver.
  • the fiber is treated by carboxymethylation.
  • the absorption rate of the solution A is above 1500%;
  • FIG. 1 is a diagram showing the inhibition zone of the wound dressing of Example 2 of the present invention after one day in a Staphylococcus aureus culture dish, showing the bacteriostatic condition of the wound dressing after one day in a S. aureus culture dish. It can be seen that the wound dressing has better antibacterial properties.
  • Example 3 the first outer layer fabric and the second outer layer fabric were prepared as spunlaced lyocell fabrics, and the fibers of the intermediate fiber layer fabric were wound dressings of modified chitosan fibers.
  • Example 3 The specific preparation method of Example 3 is:
  • Both the first outer fabric and the second outer fabric are provided with a spunlaced lyocell fabric having a basis weight of 30 g/m 2 , a bulk density of 0.13 g/cm 3 and a white color.
  • the fibers of the intermediate fiber layer fabric are provided by our company's self-made acylated chitosan fiber, the fiber linear density is 2.0 dtex, the fiber length is 50 mm, and the absorption rate of the solution A is over 2000%.
  • Example 4 the first outer layer fabric and the second outer layer fabric were prepared as wound dressings of fibers containing a silvery nylon fiber fabric and an intermediate fiber layer fabric as modified cellulose fibers.
  • Example 4 The specific preparation method of Example 4 is:
  • the first outer fabric and the second outer fabric are provided by American-made silver-plated knitted nylon Cloth, gram weight 31 g / m2, bulk density 0.14 g / cm3, color is black gray, containing 22% of silver;
  • the fiber of the intermediate fiber layer fabric is made of our own self-made carboxymethyl cellulose fiber, the fiber linear density is 2.2 dtex, the fiber length is 50 mm, and the absorption rate of the solution A is over 2000%;
  • the first outer layer fabric and the second outer layer fabric are prepared as a wound dressing of a cellulose-containing nylon fabric and an intermediate fiber layer fabric, wherein the fibers are modified cellulose fibers, and are ultrasonically welded.
  • Example 5 The specific preparation method of Example 5 is:
  • the first outer fabric and the second outer fabric are provided by China Zhejiang silver-plated knitted nylon fabric, with a weight of 129 g/m2, a bulk density of 0.32 g/cm 3 and a black color. 25% silver;
  • the fiber of the intermediate fiber layer fabric is composed of our own carboxymethyl cellulose fiber and the purchased polyethylene/polypropylene bicomponent fiber.
  • the carboxymethyl cellulose fiber has a linear density of 2.2 dtex and a fiber length of 50 mm.
  • the absorption rate of the solution A is above 2000%, the polyethylene/polypropylene bicomponent fiber ES-C, the fiber linear density is 2.5 dtex, and the fiber length is 45 mm;
  • FIG. 2 is a diagram showing the inhibition zone of the wound dressing of Example 6 of the present invention after one day in a P. aeruginosa culture dish, showing the bacteriostatic condition of the wound dressing after one day in a S. aureus culture dish. It can be seen that the wound dressing has better antibacterial properties.
  • Example 6 the first outer fabric and the second outer fabric were prepared as asymmetric polypropylene
  • the fibers of the fiber fabric and the intermediate fiber layer fabric are wound dressings of MG type calcium alginate fibers.
  • One of the first outer fabric and the second outer fabric provided is a melt spunbonded polypropylene nonwoven fabric having a basis weight of 12 g/m 2 , a bulk density of 0.08 g/cm 3 and a white color; the other layer It is a melt spunbonded polypropylene nonwoven fabric with a weight of 34 g/m2, a bulk density of 0.11 g/cm 3 and an orange-red color;
  • the fiber of the intermediate fiber layer fabric is composed of our own MG type calcium alginate fiber and the purchased low melting point polyethylene/polypropylene bicomponent fiber.
  • the calcium alginate fiber has a linear density of 3.0 dtex and a fiber length of 75 mm.
  • the absorption rate of the solution A is above 1400%;
  • the low melting point polyethylene/polypropylene bicomponent fiber ES-C the fiber linear density is 2.5 dtex, and the fiber length is 45 mm;
  • the fabric obtained in the above step is fed into an oven at a temperature of 140 degrees for 2 minutes to bond the bicomponent fibers in the fabric, and a pair of hot pressing rolls are arranged at the outlet of the oven, and the surface temperature of the rolls is 140 degrees to the middle.
  • the layer is sandwiched by the two polypropylene spunbond fabrics, the white outer layer is on top, the orange color is on the bottom, and then fed together with the hot press roll, and finally the three layers of fabric are combined to obtain a composite fabric; wherein the press roll has a bit shape
  • the pressure point makes the prepared composite fabric also have a bit pattern.
  • the fabric is white on the top and the bottom fabric is orange-red. Generally, in the clinical aspect, the white side is in contact with the wound, and the orange-red side is outward.

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Abstract

一种含有三层织物的伤口敷料，包括位于伤口敷料两个外表面的第一外层织物（1）、第二外层织物（3）以及位于第一外层织物（1）、第二外层织物（3）之间的中间纤维层织物（2）。所述第一外层织物（1）和第二外层织物（3）的体积密度均大于中间纤维层织物（2）的体积密度。所述第一外层织物（1）和第二外层织物（3）的克重均在8-140克/平方米之间，体积密度均在0.08-0.32克/立方厘米之间。该伤口敷料具有高保湿性，可以吸收大量的伤口渗出液并很好地锁住吸收进入中间纤维层织物（2）的伤口渗出液，防止渗出液回流至伤口引起伤口二次感染。

Description

含有三层织物的伤口敷料及其制备方法 技术领域
本发明涉及一种含有三层织物的伤口敷料及其制备方法。
背景技术
目前，在对溃疡性伤口进行护理时，医护人员大多采用具有高吸湿的现代伤口敷料，尤其是纤维类伤口敷料，该类敷料由具有溶胶性能的纤维组成，如海藻酸钙伤口敷料、壳聚糖伤口敷料、改性纤维素伤口敷料等。这些敷料的特点是具有较高的吸湿性和保湿性，在吸收伤口渗出液之后可以形成凝胶，从而为伤口愈合提供一个相对湿润的环境。
目前，市场上已有的高吸湿性纤维类伤口敷料除了单一组分纤维组成的敷料外，还有通过多种组分纤维混合的方法制得的多组分纤维类敷料，如在溶胶性纤维中加入非溶胶性纤维进行混纺，得到的敷料既具有较高的吸湿性能，同时具有一定的湿强度。
欧洲专利EP0740554和美国专利US6471982公开了一种可凝胶纤维如海藻酸纤维与普通非凝胶纤维如纤维素纤维混纺得到的纤维敷料。
美国专利US 6458460和欧洲EP0927013公开了另外一种伤口敷料，其由两种溶胶纤维混制而成的，一种是羧甲基纤维素纤维，另一种是海藻酸纤维，以促进吸湿性能并达到吸收伤口渗液的最佳效果。
美国专利US7385101公开了一种由镀银尼龙纤维和吸湿性纤维混纺而成的伤口敷料，该敷料含有抗菌剂银，可用于感染伤口的处理。
上述由多种纤维混合得到的敷料，虽然具有一定的综合性能，如高吸收性、高湿强度、抗菌性等，但由于敷料的结构是由两种或两种以上的纤维均匀混合后制得的，敷料通常只有一个体积密度，锁水性较差；且敷料与伤口接触部分仍是纤维状结构，在更换敷料时，部分纤维碎屑容易残留在伤口上，从而产生粘连，此时，需用大量的生理盐水冲洗伤口，从而增加患者的疼痛，并增加护理人员的工作量。
事实上，除了通过纤维混纺工艺制备敷料以外，也可以通过制备 多层结构的敷料，得到具有一定综合性能或特定功能的敷料。
欧洲专利EP0575090B1公开了一种可以吸收伤口渗出液的产品，该产品含有藻酸盐，藻酸盐可以是颗粒状、片状、球状等形式并装在一个有孔的乙烯/甲基丙烯酸酯袋子里，袋子之间由细绳连接起来；该产品另外一种形式是球状的藻酸盐直接通过细绳连接起来，外面套上有孔的圆柱形袋子。伤口渗出液通过袋子上的孔洞，被袋子里面的藻酸盐吸收，从而达到吸收伤口渗出液的目的。
欧洲专利EP0788378B1公开了一种三层结构的伤口敷料，该敷料的第一层材料(如海藻酸钙及其衍生物、壳聚糖及其衍生物等)可以有效地促进伤口愈合，第二层材料包括纤维类机织物、非织造布或者针织物，其具有比第一层材料更好的亲水性，第三层材料是一层透气膜如聚氨酯，用于把敷料固定在伤口上，但是仍然存在更换敷料时纤维残留以及保湿度性能不佳的问题。
专利WO2010/109239A1和中国专利CN102481208A公开了一种层状组合物的伤口敷料，该组合物由三层材料组成，第一层为凝胶材料，如水凝胶或水状胶体；第二层材料硬度大于第一层材料，如聚酯；第三层材料拉伸模量小于第二层材料，如低摩擦材料。该敷料舒适柔韧，可以吸收和选择性地保留伤口渗出液，有利于保持伤口湿润，可用于急性或慢性伤口的护理。但该敷料使用的是水凝胶材料，没有纤维类敷料的柔软性。
美国专利US2011/0280926A1和中国专利CN102076291A公开了一种多层伤口敷料，该敷料包含伤口接触层和吸收层，其吸收层包含亲水性聚氨酯发泡材料，可用于伤口的治疗。但该敷料使用的是聚氨酯材料，没有纤维类敷料的柔软性。
专利WO2007/117237A1和中国专利CN101460202A公开了一种增强的可吸收多层止血伤口敷料，其包含第一种可吸收的非织造织物、第二种可吸收的机织织物或针织物、凝血酶和/或纤维蛋白质。该专利涉及的敷料没有很好的保湿性能。
美国专利US6552244和欧洲专利EP1139946也公布了一个多层结构的伤口敷料，该敷料的上层是一种吸湿纤维层，中间是一层网状结构的导湿层，如黏胶网，底层的主要特点是有一定透汽能力。该敷料 的主要作用是把伤口分泌液尽快导出，其吸湿保湿能力还湿有限的。
综上所述，提供一种能够克服上述现有技术不足的伤口敷料，成为本领域技术人员亟待解决的问题。
公开于该发明背景技术部分的信息仅仅旨在加深对本发明的一般背景技术的理解，而不应当被视为承认或以任何形式暗示该信息构成已为本领域技术人员所公知的现有技术。
发明内容
为解决上述现有技术中各种不足的问题，本发明的目的是提供一种具有高吸湿性的伤口敷料及其制备方法。
为了达到上述目的，本发明提供一种含有三层织物的伤口敷料，其包括：位于伤口敷料两个外表面的第一外层织物、第二外层织物以及位于第一外层织物、第二外层织物之间的中间纤维层织物；所述第一外层织物和第二外层织物的体积密度均大于中间纤维层织物的体积密度；所述第一外层织物和第二外层织物的克重均在8-140克/平方米之间，体积密度均在0.08-0.32克/立方厘米之间；所述第一外层织物和第二外层织物的克重优选为均在10-100克/平方米而体积密度优选为均在0.08-0.25克/立方厘米之间。
进一步地，所述第一外层织物和第二外层织物中的至少一个选自海藻酸盐纤维织物、壳聚糖纤维织物、纤维素纤维织物、羧甲基壳聚糖纤维织物、酰化壳聚糖纤维织物、羧甲基纤维素纤维织物、羧乙基纤维素纤维织物、不溶于水的纤维素烷基磺酸纤维织物、维纶纤维织物、丙纶纤维织物、涤纶纤维织物、尼纶纤维织物、晴纶纤维织物或者上述两种或者两种以上纤维的混纺织物。
进一步地，所述第一外层织物和第二外层织物中的至少一个含有抗菌剂，抗菌剂含量在0.01％-25％之间，优选为在0.1％-20％之间；所述中间纤维层织物纤维含有抗菌剂，抗菌剂含量在0.01％-20％之间，优选为在0.1％-10％之间；所述抗菌剂优选为银。
进一步地，所述第一外层织物和第二外层织物中的至少一个是针织物、机织物或者非织造布；所述中间纤维层织物为非织造布织物；所述针织物和机织物由短纤纱线织成或者由长丝织成，短纤纱线纤维 线密度或长丝线密度在0.5-10.0分特之间，优选地在1-6分特之间。
进一步地，所述中间纤维层织物含有海藻酸盐纤维、壳聚糖纤维、纤维素纤维、羧甲基壳聚糖纤维、酰化壳聚糖纤维、羧甲基纤维素纤维、羧乙基纤维素纤维、不溶于水的纤维素烷基磺酸纤维、双组分纤维、维纶纤维、丙纶纤维、涤纶纤维、尼纶纤维、晴纶纤维、交联丙烯酸纤维、木浆纤维或者上述两种或两种以上纤维混纺而成的纤维。
进一步地，所述中间纤维层织物的克重为60-600克/平方米之间，优选地为80-500克/平方米之间，更优选地为100-400克/平方米之间。
进一步地，所述中间纤维层织物纤维的线密度在0.5-10.0分特之间，优选地在1-6分特之间；纤维长度在3-150毫米之间，优选地在5-75毫米之间。
进一步地，所述非织造布的成布方式为针刺成布、水刺成布、热熔成布或者化学粘结成布。
进一步地，所述第一外层织物和第二外层织物与中间纤维层织物通过针刺方式、热熔方式复合、化学粘合方式或者超声波焊接方式进行复合；在热熔或超声波焊接方式复合的情况下，所述复合的敷料具有图案，所述图案为方形、三角形、长方形、菱形、圆形或点状形。
进一步地，本发明的含有三层织物的伤口敷料用于护理溃疡性伤口的用途。
本发明还提供一种制备方法，用于制备上述的含有三层织物的伤口敷料，包括：A)提供用于制备的原始加工材料，即所述第一外层织物和第二外层织物和中间纤维层织物的纤维材料，并对材料的各项参数进行测量；B)对纤维材料进行加工形成纤维网；C)将纤维网加工成为中间纤维层织物；D)将所述中间纤维层织物与所述第一外层织物和第二外层织物进行复合加工，得到复合织物；E)将复合织物封装灭菌，得到三层织物的伤口敷料。
本发明的有益效果是：
1、本发明的伤口敷料由第一外层织物和第二外层织物和中间纤维层织物组成，其中，中间纤维层织物体积密度小，结构蓬松，更容易将伤口分泌液保持在织物结构中。
2、本发明的伤口敷料的第一外层织物和第二外层织物的体积密度 大于中间纤维层织物的体积密度，可以很好地锁住吸收进入中间纤维层的伤口渗出液，防止渗出液回流至伤口引起伤口二次感染。
3、由于该敷料具有三层结构，且第一外层织物和第二外层织物的体积密度大于中间纤维层的体积密度，使得敷料的强度尤其是湿强度有所提高，因此，在更换敷料时，敷料不容易破损，可以整片去除，而且没有纤维碎屑脱落。
附图说明
图1为本发明的实施例2的伤口敷料在黄色葡萄球菌培养皿中1天后的抑菌圈的照片。
图2为本发明的实施例5的伤口敷料在铜绿假单胞菌培养皿中1天后的抑菌圈的照片。
图3为本发明的结构示意图。
图4为本发明的制备方法流程图。
具体实施方式
在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似推广，因此本发明不受下面公开的具体实施例的限制。
下面，结合附图对本发明的具体实施例进行描述。请参阅图1至图4所示，本发明提供一种含有三层织物的伤口敷料及其制备方法。
本发明的含有三层织物的伤口敷料包括三层织物，如图3所示，其中第一层织物为第一外层织物1，第二层织物为中间纤维层织物2，第三层织物为第二外层织物3。第一外层织物1、第二外层织物3位于伤口敷料两个外表面，中间纤维层织物2位于第一外层织物1、第二外层织物3之间。
其中所述第一外层织物和第二外层织物的体积密度均大于第二层的中间纤维层织物的体积密度。所述第一外层织物和第二外层织物的克重均在8-140克/平方米之间，优选地在10-100克/平方米；体积密度均在0.08-0.32克/立方厘米之间，优选地在0.08-0.25克/立方厘米之间。
本发明的伤口敷料中，第一外层织物和第二外层织物均可以选自海藻酸盐纤维织物，或壳聚糖纤维织物，或纤维素纤维织物，或改性壳聚糖纤维织物，或改性纤维素纤维织物，也可以为维纶纤维织物，或丙纶纤维织物，或涤纶纤维织物，或尼纶纤维织物，或晴纶纤维织物，或上述两种或者两种以上纤维的混纺织物。也即，第一外层织物和第二外层织物可以是同一种织物，也可以是上述织物的任意两种，即这种三层织物敷料的结构可以是对称的(第一外层织物和第二外层织物相同)，也可以是不对称的(第一外层织物和第二外层织物不相同)。
其中，所述海藻酸盐纤维为高甘露糖醛酸(M)型、高古洛糖醛酸(G)型或者甘露糖醛酸/古洛糖醛酸(M/G)混合型。所述海藻酸盐纤维为海藻酸钙纤维或者海藻酸钙/钠纤维。所述壳聚糖纤维可以是脱乙酰度为80％以上的壳聚糖纤维。所述改性壳聚糖纤维可以是经过羧甲基化学改性的羧甲基壳聚糖纤维或者是经过酰化改性的酰化壳聚糖纤维，以提高其吸收性能，其对蒸馏水的吸收率达500％或以上。所述纤维素纤维可以是常规黏胶纤维，也可以是溶剂纺纤维素纤维如莱塞尔纤(Lyocell)纤维。所述改性纤维素纤维可以是经过化学改性的羧甲基纤维素纤维、羧乙基纤维素纤维或不溶于水的纤维素烷基磺酸纤维，其对蒸馏水的吸收率达500％或以上。
第一外层织物和第二外层织物其中之一或全部都含有抗菌剂，如银、PHMB或蜂蜜，其中优选银或其他含银材料，例如是银化合物和银络合物。制备时，可以先在纤维内部或表面加银然后制备成织物，也可以直接在织物内部或表面加银。所述含银织物的含银量在0.01％-25％，优选为0.1％-20％。
本发明并不限制在纤维中加入银的方法，所述加入银的方法主要包括：
1、在纺丝溶液中加入抗菌剂，如硝酸银、氯化银、碳酸银或者磷酸氢锆钠银(Silver Sodium Zirconium Hydrogen phosphate)，使得制成后的纤维含有抗菌剂；
2、在纤维或织物表面喷涂含银液体，如在纤维或织物表面喷涂纳米银溶液；
3、在纤维、织物表面镀银。
进一步地，所述第一外层织物和第二外层织物层之一或两层都是针织物、机织物或者非织造布，所述针织物是通过针织工艺制备的织物，所述机织物是通过机织工艺制备的织物，所述非织造布是通过非织造工艺制得的织物。
如果是针织物或机织物，其织物可以是由短纤纱线织成的，即经过短纤纺纱织布等工艺制备的织物，也可以是由长丝线织成的，其纤维或长丝线密度在0.5-10分特(dtex)之间。优选地在1-6分特之间。如果是非织造布，其成布方式可以是针刺成布、水刺成布、热熔成布或化学粘结成布。水刺成布和热熔成布只适用于一些特定纤维，如水刺成布适用于非凝胶纤维，热熔成布适用熔融纺制备的纤维，比较常见的是纺粘非织造布。
而所述中间纤维层织物可以含有海藻酸盐纤维、壳聚糖纤维、粘胶纤维素纤维、莱塞尔纤维素纤维、羧甲基壳聚糖纤维、酰化壳聚糖纤维、羧甲基纤维素纤维、羧乙基纤维素纤维、不溶于水的纤维素烷基磺酸纤维、双组分低熔点纤维；也可以是维纶纤维、丙纶纤维、涤纶纤维、尼纶纤维、晴纶纤维、交联丙烯酸纤维(cross-linked acrylate copolymer fibre)或者木浆纤维，也即所述中间纤维层织物的纤维可以为上述各种纤维的其中一种。
另外，本发明所述的中间纤维层织物，还可以通过纤维混纺制备具有综合功能的敷料。本发明所涉及的伤口敷料中，所述中间纤维层织物的纤维可以是由下列两种或两种以上纤维混纺组合而成：海藻酸盐纤维、壳聚糖纤维、粘胶纤维素纤维、莱塞尔纤维素纤维、羧甲基壳聚糖纤维、酰化壳聚糖纤维、羧甲基纤维素纤维、羧乙基纤维素纤维、不溶于水的纤维素烷基磺酸纤维、双组分低熔点纤维、维纶纤维、丙纶纤维、涤纶纤维、尼纶纤维、晴纶纤维、交联丙烯酸纤维(cross-linked acrylate copolymer fibre)以及木浆纤维。比如将海藻酸钙纤维与壳聚糖纤维混纺，所制备的敷料具有吸湿性，同时还具有壳聚糖的止血功能。为了进一步提高敷料的吸湿性能，还可以将海藻酸钙纤维与羧甲基纤维素纤维混纺。为了提高敷料的湿强度，还可以将改性纤维素纤维与未改性纤维素纤维(如Lyocell)混纺。
另外，为了使伤口敷料具有抗感染功效，上述中间纤维层织物可以含有抗菌剂，所述抗菌剂可以是银、PHMB或蜂蜜等，优选为银离子，银化合物，银络合物或在纤维或织物表面镀银，其抗菌剂含量在0.01％-20％之间，优选为0.1％-10％。
本发明敷料的中间纤维层织物的克重为60-600克/平方米之间，优选80-500克/平方米之间，更优选100-400克/平方米之间。
本发明使用的中间层纤维层织物的纤维为短纤维，可以根据伤口敷料的结构和生产工艺将长丝或纤维切断成一定的长度，所述纤维长度为3-150mm之间，优选地在5-75毫米之间。并且纤维具有一定的线密度，所述纤维的线密度为0.5-10dtex，优选地在1-6分特之间。另外，所述中间纤维层织物是一种非织造布织物，可以通过针刺非织造工艺制得。其成布方式可以是针刺成布、热熔成布或化学粘结成布。
在本发明所涉及的伤口敷料中，所述第一外层织物和第二外层织物与中间纤维层织物的复合可以通过针刺方式、热熔方式、超声波焊接方式或化学粘合方式实现。针刺方式和化学粘合简单易于实施，可以适用于所有纤维，热熔方式和超声波焊接方式只适用于那些中间层织物中含有双组分纤维(如聚乙烯/聚丙烯等)或熔融纺的纤维。针刺方式复合的敷料手感柔软，而化学粘合方式复合的敷料手感较硬。热熔方式和超声波焊接方式可以通过热压和焊头在复合的敷料表面形成图案。常见的图案有方形、三角形、长方形、菱形、圆形或点状形。这些图案有时可以防止伤口分泌液横向扩散，使敷料具有横向锁水能力。
本发明还提供一种制备方法，制备上述含有三层织物的伤口敷料，所述制备方法包括：
A)提供用于制备的原始加工材料，即第一外层织物和第二外层织物和中间纤维层织物的纤维材料，并对材料的各项参数进行测量；
B)对中间纤维层织物的纤维材料进行加工形成纤维网；
C)将纤维网加工成中间纤维层织物；
D)将该中间纤维层织物用前述的第一外层织物和第二外层织物进行复合加工，得到复合织物；
E)将复合织物封装灭菌，得到三层织物的伤口敷料。
由上可知，在制备方法中，需要对一些参数进行一些测量，下面对本发明中用到的测量方法进行描述：
1)测量织物克重：
将织物剪成四方形或长方形，测量其重量G(克)，然后铺在一个平面上测量织物长度L(厘米)和织物宽度W(厘米)。克重Gk由用下列公式计算得出：
Figure PCTCN2014089318-appb-000001
其中，Gk为克重，G为织物的重量，L为织物的长度，W为织物的宽度。
2)测量织物厚度和体积密度：
将织物平放在厚度仪压脚之间，压脚直径30毫米，测量时压力0.5N。在压脚自由压在织物上而且读数稳定后读取织物厚度D(毫米)，厚度值D精确至小数点后3位。
根据1)中测量的重量和长宽，体积密度P由下列公式计算得出：
Figure PCTCN2014089318-appb-000002
其中，P为体积密度，G为织物的重量，L为织物的长度，W为织物的宽度，D为织物的厚度。
3)测量纤维线密度：按照GB/T 14335化学纤维/短纤维线密度试验方法进行测量。
4)测量纤维长度：按照GB/T 14336-2008化学纤维/短纤维长度试验方法进行测量。
下面结合各种具体的实施例详细阐述本发明的伤口敷料结构组成和相应的制备方法。本发明的实施例中所用到的材料和试剂，除非另外说明之外均为市售产品。
实施例1
实施例1中，制备第一外层织物和第二外层织物为丙纶纤维织物、中间纤维层织物的纤维为MG型海藻酸钙纤维的伤口敷料。
实施例1的具体制备方法为：
A)提供用于制备的原始加工材料，即第一外层织物和第二外层织 物材料和中间纤维层织物的纤维材料，并利用上述的测量方法对材料的各项参数进行测量：
提供的第一外层织物和第二外层织物均采用熔融纺粘聚丙烯非织造布，克重12克/平方米，体积密度0.08克/立方厘米，颜色为白色；
提供的中间纤维层织物的纤维采用本公司自制的MG型海藻酸钙纤维，纤维的线密度为3.0dtex，纤维长度75毫米，其对A溶液吸收率在1400％以上；
B)将500克海藻酸钙纤维用开松机开松后喂入梳理机，经梳理后铺网形成纤维网；
C)将纤维网针刺成布，针刺密度60/平方厘米，制成中间纤维层织物，该中间纤维层织物的克重为99克/平方米，体积密度为0.07克/立方厘米；
D)将该中间纤维层织物用前述的第一外层织物和第二外层织物(熔融纺粘聚丙烯非织造布)夹在一起，然后再次喂入针刺机针刺复合，用两道针刺，第一道针刺向下，第二道向上，针刺密度总100/平方厘米，得到复合织物；
E)将按上述步骤制得的复合织物切成10x10厘米，用纸塑袋包装后，通过25-50千戈瑞的伽马辐照灭菌，得到三层织物的伤口敷料。
根据YY/T 0471.1-2004“接触性创面敷料试验方法”第1部分及EN 13726-1:2002/AC:2003Test methods for primary wound dressings(主要的伤口敷料的测试方法)3.2部分测试敷料的吸收性，测得该敷料的对A溶液的吸收率是19克/100平方厘米。
实施例2
实施例2中，制备第一外层织物和第二外层织物为丙纶纤维织物、中间纤维层织物的纤维为含银羧甲基纤维素纤维的伤口敷料。
实施例2的具体制备方法为：
A)提供用于制备的原始加工材料，即第一外层织物和第二外层织物材料和中间纤维层织物的纤维材料，并利用上述的测量方法对材料的各项参数进行测量：
提供的第一外层织物和第二外层织物均为熔融纺粘聚丙烯非织造 布，克重12克/平方米，体积密度0.08克/立方厘米，颜色为白色；
提供的中间纤维层织物的纤维采用本公司自制的含银羧甲基纤维素纤维，纤维线密度为1.7dtex，纤维长度为50毫米，含1.0％银，该纤维经羧甲基化处理，其对A溶液的吸收率在1500％以上；
B)将500克经羧甲基化处理后的含银羧甲基纤维素纤维用开松机开松后喂入梳理机，经梳理后铺网形成纤维网；
C)将纤维网针刺成布，针刺密度60/平方厘米，制成中间纤维层织物，该中间纤维层织物的克重130克/平方米，体积密度是0.078克/立方厘米；
D)将该中间纤维层织物用前述的第一外层织物和第二外层织物(熔融纺粘聚丙烯非织造布)夹在一起，然后再次喂入针刺机针刺复合，用两道针刺，第一道针刺向下，第二道向上，针刺密度总100/平方厘米，得到复合织物。
E)将按上述步骤制得的复合织物切成10x10厘米，用纸塑袋包装后，通过25-50千戈瑞的伽马辐照灭菌，得到三层织物的伤口敷料。
根据YY/T 0471.1-2004“接触性创面敷料试验方法”第1部分及EN 13726-1:2002/AC:2003Test methods for primary wound dressings(主要的伤口敷料的测试方法)3.2部分测试敷料的吸收性，测得该敷料的对A溶液的吸收率是22克/100平方厘米。敷料整体含银量0.8％。
为了观察敷料的抗菌功能，在培养皿中均匀地涂布一定量的大肠杆菌，然后将实施例2所得到的伤口敷料切成2×2cm放入其中，在恒温37℃下连续培养24小时，每天观察平板上的细菌生长情况。图1为本发明的实施例2的伤口敷料在黄色葡萄球菌培养皿中1天后的抑菌圈，显示了该伤口敷料在金黄色葡萄球菌培养皿中1天后的抑菌情况。可以看出，该伤口敷料具有较好的抗菌性能。
实施例3
在实施例3中，制备第一外层织物和第二外层织物为水刺莱赛尔纤维织物、中间纤维层织物的纤维为改性壳聚糖纤维的伤口敷料。
实施例3的具体制备方法为：
A)提供用于制备的原始加工材料，即第一外层织物和第二外层织 物材料和中间纤维层织物的纤维材料，并利用上述的测量方法对材料的各项参数进行测量：
提供的第一外层织物和第二外层织物均采用水刺莱赛尔纤维织物，克重30克/平方米，体积密度0.13克/立方厘米，颜色为白色。
提供的中间纤维层织物的纤维采用本公司自制的酰化壳聚糖纤维，纤维线密度为2.0dtex，纤维长度为50毫米，其对A溶液吸收率在2000％以上。
B)将500克酰化壳聚糖纤维用开松机开松后喂入梳理机，经梳理后铺网形成纤维网；
C)将纤维网针刺成布，针刺密度40/平方厘米，制成中间纤维层织物，该中间纤维层织物的克重125克/平方米，体积密度是0.075克/立方厘米；
D)将该中间纤维层织物用前述的第一外层织物和第二外层织物(水刺莱赛尔纤维织物)夹在一起，然后再次喂入针刺机针刺复合，用两道针刺，第一道针刺向下，第二道向上，针刺密度总100/平方厘米，得到复合织物；
E)将按上述步骤制得的复合织物切成10x10厘米，用纸塑袋包装后，通过25-50千戈瑞的伽马辐照灭菌，得到三层织物的伤口敷料。
根据YY/T 0471.1-2004“接触性创面敷料试验方法”第1部分及EN 13726-1:2002/AC:2003Test methods for primary wound dressings(主要的伤口敷料的测试方法)3.2部分测试敷料的吸收性，测得该敷料的对A溶液的吸收率是16克/100平方厘米。
实施例4
在实施例4中，制备第一外层织物和第二外层织物为含银尼纶纤维织物、中间纤维层织物的纤维为改性纤维素纤维的伤口敷料。
实施例4的具体制备方法为：
A)提供用于制备的原始加工材料，即第一外层织物和第二外层织物材料和中间纤维层织物的纤维材料，并利用上述的测量方法对材料的各项参数进行测量：
提供的第一外层织物和第二外层织物均采用美国产镀银针织尼纶 布，克重31克/平方米，体积密度0.14克/立方厘米，颜色为黑灰色，含银量22％；
提供的中间纤维层织物的纤维采用本公司自制的羧甲基纤维素纤维，纤维线密度为2.2dtex，纤维长度为50毫米，其对A溶液吸收率在2000％以上；
B)将500克羧甲基纤维素纤维用开松机开松后喂入梳理机，经梳理后铺网形成纤维网；
C)将纤维网针刺成布，针刺密度40/平方厘米，制成中间纤维层织物，该层织物的克重125克/平方米，体积密度是0.075克/立方厘米；
D)将该中间纤维层织物用前述的第一外层织物和第二外层织物(镀银针织尼纶布)夹在一起，然后再次喂入针刺机针刺复合，用两道针刺，第一道针刺向下，第二道向上，针刺密度总100/平方厘米，得到复合织物；
E)将按上述步骤制得的复合织物切成10x10厘米，用纸塑袋包装后，通过25-50千戈瑞的伽马辐照灭菌，得到三层织物的伤口敷料。
根据YY/T 0471.1-2004“接触性创面敷料试验方法”第1部分及EN 13726-1:2002/AC:2003Test methods for primary wound dressings(主要的伤口敷料的测试方法)3.2部分测试敷料的吸收性，测得该敷料的对A溶液的吸收率是16克/100平方厘米。
实施例5
在实施例5中，制备第一外层织物和第二外层织物为含银尼纶纤维织物、中间纤维层织物的纤维为改性纤维素纤维的伤口敷料，用超声波焊接方式复合。
实施例5的具体制备方法为：
A)提供用于制备的原始加工材料，即第一外层织物和第二外层织物材料和中间纤维层织物的纤维材料，并利用上述的测量方法对材料的各项参数进行测量：
提供的第一外层织物和第二外层织物均采用中国浙江镀银针织尼纶布，克重129克/平方米，体积密度0.32克/立方厘米，颜色为黑色。含银量25％；
提供的中间纤维层织物的纤维由本公司自制的羧甲基纤维素纤维和采购的聚乙烯/聚丙烯双组分纤维组成，羧甲基纤维素纤维线密度为2.2dtex，纤维长度为50毫米，其对A溶液吸收率在2000％以上，聚乙烯/聚丙烯双组分纤维ES-C，纤维线密度为2.5dtex，纤维长度为45毫米；
B)将500克羧甲基纤维素纤维和100克聚乙烯/聚丙烯双组分纤维ES-C先用手工混合均匀，然后一起用开松机开松后喂入梳理机，经梳理后铺网形成纤维网；
C)将纤维网针刺成布，针刺密度80/平方厘米，制成中间纤维层织物，该中间纤维层织物的克重139克/平方米，体积密度是0.103克/立方厘米；
D)将该中间纤维层织物用前述的第一外层织物和第二外层织物(镀银针织尼纶布)夹在一起，然后一起放在超声波头与下辊之间，利用高频超声波使焊头下局部温度达到双组分纤维的熔点，使得中间纤维层织物与第一外层织物和第二外层织物复合，得到复合织物并在表面外层织物上形成菱形图案；
E)将按上述步骤制得的复合织物切成10x10厘米，用纸塑袋包装后，通过环氧乙烷灭菌，得到三层织物的伤口敷料。
根据YY/T 0471.1-2004“接触性创面敷料试验方法”第1部分及EN 13726-1:2002/AC:2003Test methods for primary wound dressings(主要的伤口敷料的测试方法)3.2部分测试敷料的吸收性，测得该敷料的对A溶液的吸收率是15克/100平方厘米。
为了观察敷料的抗菌性能，在培养皿中均匀地涂布一定量的大肠杆菌，然后将实施例6所得到的伤口敷料切成2×2cm放入其中，在恒温37℃下连续培养24小时，每天观察平板上的细菌生长情况。图2为本发明的实施例6的伤口敷料在铜绿假单胞菌培养皿中1天后的抑菌圈，显示了该伤口敷料在金黄色葡萄球菌培养皿中1天后的抑菌情况。可以看出，该伤口敷料具有较好的抗菌性能。
实施例6
在实施例6中，制备第一外层织物和第二外层织物为不对称丙纶 纤维织物、中间纤维层织物的纤维为MG型海藻酸钙纤维的伤口敷料。
A)提供用于制备的原始加工材料，即第一外层织物和第二外层织物材料和中间纤维层织物的纤维材料，并利用上述的测量方法对材料的各项参数进行测量：
提供的第一外层织物和第二外层织物中，一层为熔融纺粘聚丙烯非织造布，克重12克/平方米，体积密度0.08克/立方厘米，颜色为白色；另一层为熔融纺粘聚丙烯非织造布，克重34克/平方米，体积密度0.11克/立方厘米，颜色为橘红色；
提供的中间纤维层织物的纤维由本公司自制的MG型海藻酸钙纤维和采购的低熔点聚乙烯/聚丙烯双组分纤维组成，海藻酸钙纤维线密度为3.0dtex，纤维长度为75毫米，其对A溶液吸收率在1400％以上；低熔点聚乙烯/聚丙烯双组分纤维ES-C，纤维线密度为2.5dtex，纤维长度为45毫米；
B)将1000克海藻酸钙纤维和250克低熔点聚乙烯/聚丙烯双组分纤维ES-C先用手工混合均匀，然后一起用开松机开松后喂入梳理机，经梳理后铺网形成纤维网；
C)将纤维网针刺成布，针刺密度60/平方厘米，制成中间纤维层织物，该中间纤维层织物的克重365克/平方米，体积密度是0.065克/立方厘米；
D)将上述步骤得到的织物喂入温度为140度的烘箱放置2分钟，使织物中双组分纤维粘合，在烘箱出口设置一对热压辊，辊表面温度140度，以将该中间层用前述两个聚丙烯纺粘布夹在一起，白色外层在上，橘红色在下，再一起喂入热压辊，最后将三层织物复合在一起得到复合织物；其中压辊上有点状压点，使得制备的复合织物也有点状图案。该织物上面为白色，底部织物为橘红色。一般在临床上，将白色一面与伤口接触，橘红色一面向外。
E)将按上述步骤制得的复合织物切成10x10厘米，用纸塑袋包装后，通过环氧乙烷灭菌，得到三层织物的伤口敷料。
根据YY/T 0471.1-2004“接触性创面敷料试验方法”第1部分及EN 13726-1:2002/AC:2003Test methods for primary wound dressings(主要的伤口敷料的测试方法)3.2部分测试敷料的吸收性，测得该敷 料的对A溶液的吸收率是14克/100平方厘米。
上述实施例是用于例示性说明本发明的原理及其功效，但是本发明并不限于上述实施方式。本领域的技术人员均可在不违背本发明的精神及范畴下，在权利要求保护范围内，对上述实施例进行修改。因此本发明的保护范围，应如本发明的权利要求书覆盖。

Claims (10)

  1. 一种含有三层织物的伤口敷料，包括：
    位于伤口敷料两个外表面的第一外层织物、第二外层织物以及位于第一外层织物、第二外层织物之间的中间纤维层织物；
    所述第一外层织物和第二外层织物的体积密度均大于中间纤维层织物的体积密度；
    所述第一外层织物和第二外层织物的克重均在8-140克/平方米之间，体积密度均在0.08-0.32克/立方厘米之间。
  2. 根据权利要求1所述的含有三层织物的伤口敷料，其特征在于：所述第一外层织物和第二外层织物中的至少一个选自海藻酸盐纤维织物、壳聚糖纤维织物、纤维素纤维织物、羧甲基壳聚糖纤维织物、酰化壳聚糖纤维织物、羧甲基纤维素纤维织物、羧乙基纤维素纤维织物、不溶于水的纤维素烷基磺酸纤维织物、维纶纤维织物、丙纶纤维织物、涤纶纤维织物、尼纶纤维织物、晴纶纤维织物或者上述两种或者两种以上纤维的混纺织物；所述第一外层织物和第二外层织物的克重优选为均在10-100克/平方米；体积密度优选为均在0.08-0.25克/立方厘米之间。
  3. 根据权利要求2所述的含有三层织物的伤口敷料，其特征在于：所述第一外层织物和第二外层织物中的至少一个含有抗菌剂，抗菌剂含量在0.01％-25％之间，优选为在0.1％-20％之间；所述中间纤维层织物纤维含有抗菌剂，抗菌剂含量在0.01％-20％之间，优选为在0.1％-10％之间；所述抗菌剂优选为银。
  4. 根据权利要求3所述的含有三层织物的伤口敷料，其特征在于：所述第一外层织物和第二外层织物中的至少一个是针织物、机织物或者非织造布；所述中间纤维层织物为非织造布织物；所述针织物和机织物由短纤纱线织成或者由长丝织成，所述短纤纱线纤维线密度或长丝线密度在0.5-10.0分特之间，优选地在1-6分特之间。
  5. 根据权利要求4所述的含有三层织物的伤口敷料，其特征在于：所述中间纤维层织物含有海藻酸盐纤维、壳聚糖纤维、纤维素纤维、羧甲基壳聚糖纤维、酰化壳聚糖纤维、羧甲基纤维素纤维、羧乙基纤维素纤维、不溶于水的纤维素烷基磺酸纤维、双组分纤维、维纶纤维、丙纶纤维、涤纶纤维、尼纶纤维、晴纶纤维、交联丙烯酸纤维、木浆纤维或者上述两种或两种以上纤维混纺而成的纤维。
  6. 根据权利要求5所述的含有三层织物的伤口敷料，其特征在于：所述中间纤维层织物的克重为60-600克/平方米之间，优选地为80-500克/平方米之间，更优选地为100-400克/平方米之间。
  7. 根据权利要求6所述的含有三层织物的伤口敷料，其特征在于：所述中间纤维层织物纤维的线密度在0.5-10.0分特之间，优选地在1-6分特之间；纤维长度在3-150毫米之间，优选地在5-75毫米之间。
  8. 根据权利要求4所述的含有三层织物的伤口敷料，其特征在于：所述非织造布的成布方式为针刺成布、水刺成布、热熔成布或者化学粘结成布。
  9. 根据权利要求1所述的含有三层织物的伤口敷料，其特征在于：所述第一外层织物和第二外层织物与中间纤维层织物通过针刺方式、热熔方式复合、化学粘合方式或者超声波焊接方式进行复合，在热熔或超声波焊接方式复合的情况下，所述复合的敷料具有图案，所述图案为方形、三角形、长方形、菱形、圆形或点状形。
  10. 一种制备方法，用于制备上述任一项权利要求所述的含有三层织物的伤口敷料，包括：
    A)提供用于制备的原始加工材料，即所述第一外层织物和第二外层织物和中间纤维层织物的纤维材料，并对材料的各项参数进行测量；
    B)对纤维材料进行加工形成纤维网；
    C)将纤维网加工成为中间纤维层织物；
    D)将所述中间纤维层织物与所述第一外层织物和第二外层织物进行复合加工，得到复合织物；
    E)将复合织物封装灭菌，得到三层织物的伤口敷料。
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CN103735359A (zh) 2014-04-23

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