JPH03242145A - Wound covering material and production thereof - Google Patents
Wound covering material and production thereofInfo
- Publication number
- JPH03242145A JPH03242145A JP2037698A JP3769890A JPH03242145A JP H03242145 A JPH03242145 A JP H03242145A JP 2037698 A JP2037698 A JP 2037698A JP 3769890 A JP3769890 A JP 3769890A JP H03242145 A JPH03242145 A JP H03242145A
- Authority
- JP
- Japan
- Prior art keywords
- thin film
- wound dressing
- water
- wound
- forming
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000000463 material Substances 0.000 title claims abstract description 76
- 238000004519 manufacturing process Methods 0.000 title claims description 8
- 239000010409 thin film Substances 0.000 claims abstract description 54
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 54
- 239000005871 repellent Substances 0.000 claims abstract description 27
- 229910052751 metal Inorganic materials 0.000 claims abstract description 21
- 239000002184 metal Substances 0.000 claims abstract description 21
- 230000002940 repellent Effects 0.000 claims abstract description 6
- 239000000126 substance Substances 0.000 claims description 59
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 claims description 24
- 239000004745 nonwoven fabric Substances 0.000 claims description 15
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- 230000000844 anti-bacterial effect Effects 0.000 claims description 10
- -1 polytetrafluoroethylene Polymers 0.000 claims description 10
- 229910021645 metal ion Inorganic materials 0.000 claims description 9
- 229910052709 silver Inorganic materials 0.000 claims description 9
- 239000004332 silver Substances 0.000 claims description 9
- 239000012528 membrane Substances 0.000 claims description 8
- 229920002101 Chitin Polymers 0.000 claims description 6
- 238000010521 absorption reaction Methods 0.000 claims description 6
- 230000035699 permeability Effects 0.000 claims description 6
- WCDDVEOXEIYWFB-VXORFPGASA-N (2s,3s,4r,5r,6r)-3-[(2s,3r,5s,6r)-3-acetamido-5-hydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4,5,6-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@@H]1C[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](C(O)=O)O[C@@H](O)[C@H](O)[C@H]1O WCDDVEOXEIYWFB-VXORFPGASA-N 0.000 claims description 5
- 229940014041 hyaluronate Drugs 0.000 claims description 5
- 229920002635 polyurethane Polymers 0.000 claims description 5
- 239000004814 polyurethane Substances 0.000 claims description 5
- 239000011347 resin Substances 0.000 claims description 5
- 229920005989 resin Polymers 0.000 claims description 5
- 229920002379 silicone rubber Polymers 0.000 claims description 5
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims description 4
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 4
- 229920001661 Chitosan Polymers 0.000 claims description 4
- 229940072056 alginate Drugs 0.000 claims description 4
- 235000010443 alginic acid Nutrition 0.000 claims description 4
- 229920000615 alginic acid Polymers 0.000 claims description 4
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 4
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims description 4
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims description 4
- 229940105329 carboxymethylcellulose Drugs 0.000 claims description 4
- 239000004744 fabric Substances 0.000 claims description 4
- 229920000193 polymethacrylate Polymers 0.000 claims description 4
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 4
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 4
- 229920003225 polyurethane elastomer Polymers 0.000 claims description 4
- 229920000468 styrene butadiene styrene block copolymer Polymers 0.000 claims description 4
- 239000002759 woven fabric Substances 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 3
- 150000002739 metals Chemical class 0.000 abstract description 6
- 206010052428 Wound Diseases 0.000 description 96
- 208000027418 Wounds and injury Diseases 0.000 description 96
- 239000000243 solution Substances 0.000 description 16
- VLKZOEOYAKHREP-UHFFFAOYSA-N n-Hexane Chemical compound CCCCCC VLKZOEOYAKHREP-UHFFFAOYSA-N 0.000 description 15
- 210000001519 tissue Anatomy 0.000 description 13
- 239000011248 coating agent Substances 0.000 description 10
- 238000000576 coating method Methods 0.000 description 10
- 230000000052 comparative effect Effects 0.000 description 10
- 210000000416 exudates and transudate Anatomy 0.000 description 8
- 239000000853 adhesive Substances 0.000 description 7
- 238000006243 chemical reaction Methods 0.000 description 7
- ZWEHNKRNPOVVGH-UHFFFAOYSA-N 2-Butanone Chemical compound CCC(C)=O ZWEHNKRNPOVVGH-UHFFFAOYSA-N 0.000 description 6
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical group [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 6
- 230000001070 adhesive effect Effects 0.000 description 6
- 210000002615 epidermis Anatomy 0.000 description 6
- 230000035876 healing Effects 0.000 description 6
- 229920000260 silastic Polymers 0.000 description 6
- SQGYOTSLMSWVJD-UHFFFAOYSA-N silver(1+) nitrate Chemical compound [Ag+].[O-]N(=O)=O SQGYOTSLMSWVJD-UHFFFAOYSA-N 0.000 description 6
- 210000003491 skin Anatomy 0.000 description 6
- 239000010949 copper Substances 0.000 description 5
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- 238000002474 experimental method Methods 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 241000894006 Bacteria Species 0.000 description 4
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 4
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 description 4
- 238000000354 decomposition reaction Methods 0.000 description 4
- 230000005764 inhibitory process Effects 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 4
- 230000008929 regeneration Effects 0.000 description 4
- 238000011069 regeneration method Methods 0.000 description 4
- 239000011701 zinc Substances 0.000 description 4
- 208000005422 Foreign-Body reaction Diseases 0.000 description 3
- 206010072170 Skin wound Diseases 0.000 description 3
- 239000011575 calcium Substances 0.000 description 3
- 229910052802 copper Inorganic materials 0.000 description 3
- 238000004132 cross linking Methods 0.000 description 3
- 238000006266 etherification reaction Methods 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 239000010408 film Substances 0.000 description 3
- 239000000499 gel Substances 0.000 description 3
- 239000000017 hydrogel Substances 0.000 description 3
- 208000015181 infectious disease Diseases 0.000 description 3
- 210000003141 lower extremity Anatomy 0.000 description 3
- 229920000609 methyl cellulose Polymers 0.000 description 3
- 239000001923 methylcellulose Substances 0.000 description 3
- 235000010981 methylcellulose Nutrition 0.000 description 3
- 229920000642 polymer Polymers 0.000 description 3
- 229910001961 silver nitrate Inorganic materials 0.000 description 3
- 229910052725 zinc Inorganic materials 0.000 description 3
- 102000008186 Collagen Human genes 0.000 description 2
- 108010035532 Collagen Proteins 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 239000004809 Teflon Substances 0.000 description 2
- 229920006362 Teflon® Polymers 0.000 description 2
- 230000000740 bleeding effect Effects 0.000 description 2
- 229920001436 collagen Polymers 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000010828 elution Methods 0.000 description 2
- 230000002209 hydrophobic effect Effects 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
- 230000003020 moisturizing effect Effects 0.000 description 2
- 230000001575 pathological effect Effects 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 description 2
- 230000000472 traumatic effect Effects 0.000 description 2
- JIAARYAFYJHUJI-UHFFFAOYSA-L zinc dichloride Chemical compound [Cl-].[Cl-].[Zn+2] JIAARYAFYJHUJI-UHFFFAOYSA-L 0.000 description 2
- ONDPHDOFVYQSGI-UHFFFAOYSA-N zinc nitrate Chemical compound [Zn+2].[O-][N+]([O-])=O.[O-][N+]([O-])=O ONDPHDOFVYQSGI-UHFFFAOYSA-N 0.000 description 2
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 description 1
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 241000283690 Bos taurus Species 0.000 description 1
- 208000032544 Cicatrix Diseases 0.000 description 1
- 241000588722 Escherichia Species 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- 208000035874 Excoriation Diseases 0.000 description 1
- 102000009123 Fibrin Human genes 0.000 description 1
- 108010073385 Fibrin Proteins 0.000 description 1
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 241000699670 Mus sp. Species 0.000 description 1
- 241000283977 Oryctolagus Species 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
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- 241000589517 Pseudomonas aeruginosa Species 0.000 description 1
- 229920002385 Sodium hyaluronate Polymers 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 241000191963 Staphylococcus epidermidis Species 0.000 description 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
- 150000001252 acrylic acid derivatives Chemical class 0.000 description 1
- 229940095054 ammoniac Drugs 0.000 description 1
- 230000003276 anti-hypertensive effect Effects 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 230000008952 bacterial invasion Effects 0.000 description 1
- 239000003397 biobrane Substances 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 229920001222 biopolymer Polymers 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000001110 calcium chloride Substances 0.000 description 1
- 229910001628 calcium chloride Inorganic materials 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- XTVVROIMIGLXTD-UHFFFAOYSA-N copper(II) nitrate Chemical compound [Cu+2].[O-][N+]([O-])=O.[O-][N+]([O-])=O XTVVROIMIGLXTD-UHFFFAOYSA-N 0.000 description 1
- 210000004207 dermis Anatomy 0.000 description 1
- 230000001627 detrimental effect Effects 0.000 description 1
- 238000007598 dipping method Methods 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 210000001339 epidermal cell Anatomy 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 229950003499 fibrin Drugs 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 238000007654 immersion Methods 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
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- 230000017074 necrotic cell death Effects 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 238000000879 optical micrograph Methods 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000035755 proliferation Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 235000004252 protein component Nutrition 0.000 description 1
- 239000005060 rubber Substances 0.000 description 1
- 231100000241 scar Toxicity 0.000 description 1
- 230000037387 scars Effects 0.000 description 1
- 239000000661 sodium alginate Substances 0.000 description 1
- 235000010413 sodium alginate Nutrition 0.000 description 1
- 229940005550 sodium alginate Drugs 0.000 description 1
- 229940010747 sodium hyaluronate Drugs 0.000 description 1
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
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Landscapes
- Materials For Medical Uses (AREA)
Abstract
Description
【発明の詳細な説明】
[産業上の利用分野]
本発明は、創傷被覆材およびその製造方法に関するもの
である。詳しく述べると、本発明は創傷、熱傷等による
皮膚欠損受傷の際、該皮膚欠損部位に適用され、該皮膚
欠損部位を含水状態にて保護し、疼痛を抑制し、感染を
防止して、表皮再生を促進する創傷被覆材およびその製
造方法に関する。DETAILED DESCRIPTION OF THE INVENTION [Industrial Field of Application] The present invention relates to a wound dressing and a method for manufacturing the same. Specifically, the present invention is applied to the skin defect site when the skin defect occurs due to a wound, burn, etc., protects the skin defect site in a hydrated state, suppresses pain, prevents infection, and improves the epidermis. The present invention relates to a wound dressing that promotes regeneration and a method for producing the same.
[従来の技術]
外傷性の皮膚創傷および裸皮創等の創傷および疾患に伴
う創部に対する創傷保護および材料としては、大別して
創傷部を乾燥状態に保ち、痴皮形成して治癒を行う、い
わゆるdry dressingと、適度の湿潤環境を
作成し、速やかな表皮細胞の遊送を行うwet dre
ssingとか知られており、後者は創傷の治癒も速や
かであり、創傷部表面の乾燥壊死が少なく、創面の保護
効果も有することなどが知られている。[Prior art] Wound protection and materials for wounds such as traumatic skin wounds and bare skin wounds, and wounds associated with diseases can be broadly classified into so-called wound protection materials that keep the wound dry and heal by forming skin. Dry dressing and wet dressing, which creates a moderately moist environment and allows rapid migration of epidermal cells.
ssing, and the latter is known to have rapid wound healing, less dry necrosis on the surface of the wound, and a protective effect on the wound surface.
しかし、wet dressingの一方法であるサー
ジカルドレープを用いる方法では、浸出液の貯留が多く
創面に再吸収されるおそれがあり、また、感染の危険も
大きく、接着剤が直接創面と接するため、創冶癒に有害
と思われる問題点があることが指摘されている。また、
創面から剥がれやすいこともあり、創面と接する部分に
小さな突起を付けたものもあるが、逆に、除去困難とい
う欠点を有するなどの問題点があった。However, when using a surgical drape, which is one method of wet dressing, a large amount of exudate accumulates and may be reabsorbed into the wound surface, and there is also a high risk of infection. It has been pointed out that there are problems that seem to be detrimental to healing. Also,
Because they tend to peel off from the wound surface, some have small protrusions attached to the part that comes into contact with the wound surface, but they also have the disadvantage of being difficult to remove.
これらの問題点を解決するため近年では創傷部に接触し
得る部位にコラーゲン、キチン、フィブリン等の生体高
分子を用いたもの、あるいはゴム系の素材中に保湿成分
を分散させ密着・非癒着・高含水状態の確保などを図っ
たもの、さらには、本件出願人が、以前提案した、創傷
部に接触し得る部位の少なくとも一部が撥水性物質によ
り被覆された生体適合性のヒドロゲル形成性の支持層(
例えば、カルボキシメチルセルロース、アルギン酸塩系
、ヒアルロン酸塩系、ポリ(メタ)アクリル酸塩系)と
、該支持層の創傷部に接触し得る部位とは反対側に形成
された水分透過調節層とからなる創傷被覆材(特開昭6
2−183760号公報)等があり、一定の成果をおさ
めている。In order to solve these problems, in recent years, biopolymers such as collagen, chitin, and fibrin are used in areas that can come into contact with the wound, or moisturizing ingredients are dispersed in rubber-based materials to improve adhesion and non-adhesion. In addition, the present applicant has previously proposed a biocompatible hydrogel-forming product in which at least a portion of the area that can come into contact with the wound is covered with a water-repellent material. Supporting layer (
For example, carboxymethylcellulose, alginate-based, hyaluronate-based, poly(meth)acrylate-based) and a moisture permeation regulating layer formed on the opposite side of the supporting layer from the part that can contact the wound area. Wound dressing material (Unexamined Japanese Patent Publication No. 6
2-183760), etc., and has achieved a certain degree of success.
[発明が解決しようとする問題点]
しかし、上記のものでもある程度の効果は有しているが
、創傷部と接触する部分の生体適合性を有する基剤層の
形成に用いられている材料が、分解、脱落しやす(、創
傷被覆材としての使用時における物性に問題かあり、さ
らに、その分解、離脱物が異物として認識されることが
あり、創傷部の治癒を遅延させる危険性があった。また
、支持層の創傷部に接触し得る部位とは反対側に形成さ
れる水分透過調節層は、適度な水分透過能と細菌侵入阻
止能を必要とするが、この両者の性質を満足させる材質
は、かなり限定されるものであった。[Problems to be Solved by the Invention] However, although the above-mentioned materials have some effects, the material used to form the biocompatible base layer in the part that comes into contact with the wound area is , easy to decompose and fall off (there are problems with the physical properties when used as a wound dressing, and furthermore, the decomposed and separated substances may be recognized as foreign substances, and there is a risk of delaying the healing of the wound area. In addition, the moisture permeation control layer formed on the opposite side of the support layer from the part that can come into contact with the wound area requires appropriate moisture permeability and bacterial invasion prevention ability, and the layer satisfies both of these properties. The materials that could be used were quite limited.
そこで、本発明は、高含水層の存在により浸出液の適度
の貯留確保と創面への良好な密着性、非癒着性を有し、
創傷部と接触する高含水性の支持層が、使用時に容易に
分解、離脱することがなく、創傷部の治癒、特に表皮再
生が促進され、創傷部の早期の治癒を行うことができ、
さらに水分透過調節層の性質を比較的自由に設定し得る
ことを可能とする創傷被覆材およびその製造方法を提供
することを目的とする。Therefore, the present invention ensures appropriate storage of exudate due to the presence of a high water content layer, and has good adhesion and non-adhesion to the wound surface.
The highly water-containing support layer that comes into contact with the wound does not easily decompose or come off during use, promoting the healing of the wound, especially epidermal regeneration, and enabling early healing of the wound.
Another object of the present invention is to provide a wound dressing material that allows the properties of the moisture permeation regulating layer to be set relatively freely, and a method for producing the same.
[問題点を解決するための手段]
上記目的を達成するものは、創傷部に接触し得る部位の
少なくとも一部が撥水性物質により被覆された生体適合
性を有する高含水ゲル形成性物質薄膜により形成された
支持層と、該支持層の創傷部に接触し得る部位とは反対
側に形成された水分透過調節層とからなり、前記高含水
ゲル形成性物質は、カルボキシル基を有するとともに複
数のカルボキシル基と結合した2価以上の金属を有して
いる創傷被覆材である。そして前記金属は抗菌性を有す
るものであることが好ましい。[Means for Solving the Problems] The above object is achieved by using a thin film of a biocompatible high water content gel-forming material in which at least a portion of the area that can come into contact with the wound is covered with a water-repellent material. The high water content gel-forming substance has a carboxyl group and a water permeation regulating layer formed on the opposite side of the support layer from the part that can come into contact with the wound. This is a wound dressing material containing a divalent or higher valent metal bonded to a carboxyl group. Preferably, the metal has antibacterial properties.
また、前記生体適合性高含水ゲル形成性物質が、カルボ
キシメチルセルロース系、アルギン酸塩系、ヒアルロン
酸塩系、ポリ(メタ)アクリル酸塩系、キトサン誘導体
、キチン誘導体からなる群より選ばれたものであること
が好ましい。さらに、前記高含水ゲル形成性物質薄膜は
、不織布、織布、編布または多孔質膜であることが好ま
しい。そして、前記撥水性物質は、シリコーン、ポリウ
レタン、スチレン−ブタジェンスチレンブロックコポリ
マーおよびポリテトラフルオロエチレンからなる群から
選ばれたものであることが好ましい。さらに、前記高含
水ゲル形成性物質の一部のカルボキシル基には、銀が結
合していることが好ましい。さらに、前記水分透過調節
層は、水蒸気透過性樹脂薄膜により形成されていること
が好ましい。そして、前記水蒸気透過性樹脂薄膜は、シ
リコーンエラストマー薄膜またはポリウレタンエラスト
マー薄膜であることが好ましい。そして、前記創傷被覆
材の水蒸気透過率(JIS規格)は、0゜1〜500
yttg/ ax″・hrであることが好ましい。Further, the biocompatible high water content gel-forming substance is selected from the group consisting of carboxymethyl cellulose, alginate, hyaluronate, poly(meth)acrylate, chitosan derivative, and chitin derivative. It is preferable that there be. Further, it is preferable that the thin film of the highly hydrous gel-forming material is a nonwoven fabric, a woven fabric, a knitted fabric, or a porous membrane. The water repellent material is preferably selected from the group consisting of silicone, polyurethane, styrene-butadiene styrene block copolymer, and polytetrafluoroethylene. Further, it is preferable that silver is bonded to some carboxyl groups of the high water content gel-forming substance. Furthermore, it is preferable that the moisture permeation regulating layer is formed of a water vapor permeable resin thin film. The water vapor permeable resin thin film is preferably a silicone elastomer thin film or a polyurethane elastomer thin film. The water vapor permeability (JIS standard) of the wound dressing is 0°1 to 500.
It is preferable that it is yttg/ax''·hr.
さらに、前記創傷被覆材の吸水能は、50〜500重量
%であることが好ましい。Further, the water absorption capacity of the wound dressing is preferably 50 to 500% by weight.
また、上記目的を達成するものは、生体適合性を有する
高含水ゲル形成性物質薄膜を形成あるいは準備し、該高
含水ゲル形成性物質薄膜の少なくとも一方の面に撥水性
物質溶液を接触させ乾燥させた後、該高含水ゲル形成性
物質薄膜を2価以上の金属イオンを含有する溶液に接触
させ乾燥させ、薄膜状に形成され未硬化かつ粘着性を有
する状態の水分透過性薄膜形成性物質の上に、前記高含
水ゲル形成性物質薄膜の他方の面を載置し、その後肢水
分透過性薄膜形成性物質を硬化させる創傷被覆材の製造
方法である。In addition, to achieve the above object, a thin film of a highly hydrous gel-forming substance having biocompatibility is formed or prepared, and a solution of a water-repellent substance is brought into contact with at least one surface of the thin film of the highly hydrous gel-forming substance and then dried. After that, the thin film of the highly water-containing gel-forming substance is brought into contact with a solution containing divalent or higher-valent metal ions and dried to form a water-permeable thin film-forming substance that is formed into a thin film and is uncured and sticky. In this method, the other side of the high hydrous gel-forming substance thin film is placed on top of the wound dressing, and the hindlimb water-permeable thin film-forming substance is cured.
そこで、本発明の創傷被覆材を実施例を用いて説明する
。Therefore, the wound dressing of the present invention will be explained using Examples.
第1図は、本発明の創傷被覆材の実施例の微細構造を示
す拡大断面図である。FIG. 1 is an enlarged cross-sectional view showing the microstructure of an embodiment of the wound dressing of the present invention.
本発明の創傷被覆材lは、創傷部に接触し得る部位の少
なくとも一部が撥水性物質2により被覆された生体適合
性を有する高含水ゲル形成性物質薄膜により形成された
支持層3と、支持層3の創傷部に接触し得る部位とは反
対側に形成された水分透過調節層4とからなり、支持層
3を形成する高含水ゲル形成性物質は、カルボキシル基
を有するとともに複数のカルボキシル基と結合した2価
以上の金属を有している。The wound dressing 1 of the present invention includes a support layer 3 formed of a thin film of a biocompatible high water content gel-forming material in which at least a portion of the part that can come into contact with the wound is covered with a water-repellent material 2; It consists of a moisture permeation regulating layer 4 formed on the opposite side of the support layer 3 from the part that can come into contact with the wound, and the high hydrogel forming substance forming the support layer 3 has a carboxyl group and a plurality of carboxyl groups. It has a divalent or higher valent metal bonded to the group.
そして、本発明の創傷被覆材は、上記のように構成され
ており、特に、支持層が、カルボキシル基を有する生体
適合性高含水ゲル形成性物質により形成され、さらに、
複数のカルボキシル基と結合した2価以上の金属を有し
ているため、支持層が生体適合性かつ高含水ゲル形成性
という性質を有した状態で、2価以上の金属により部分
的に配位架橋されているため、支持層として強固となっ
ており、このため支持層を形成する物質が容易に分解、
離脱することがなく、支持層が水分を吸収した際におけ
る支持層形成物質の分解、破断等に伴う被覆材の一部の
生体内への脱落を防止する。The wound dressing of the present invention is configured as described above, and in particular, the support layer is formed of a biocompatible high water content gel-forming substance having a carboxyl group, and further includes:
Since it has a divalent or higher valent metal bonded to multiple carboxyl groups, it can be partially coordinated by a divalent or higher valent metal while the support layer has the properties of biocompatibility and high hydrogel formation. Because it is cross-linked, it is strong as a support layer, so the material that forms the support layer easily decomposes.
It does not come off, and prevents part of the covering material from falling into the living body due to decomposition, breakage, etc. of the material forming the support layer when the support layer absorbs moisture.
そこで、本発明の創傷被覆材1について、第1図に示し
た実施例を参照して具体的に説明する。Therefore, the wound dressing 1 of the present invention will be specifically explained with reference to the embodiment shown in FIG.
この実施例の創傷被覆材1は、支持層3と、水分透過調
節層4とからなっている。The wound dressing 1 of this example consists of a support layer 3 and a moisture permeation regulating layer 4.
支持層3は、生体適合性の高含水ゲル形成性物質薄膜に
より形成されている。生体適合性を有するものを用いる
のは、この創傷被覆材1が創傷部に被覆された際に、生
体による異物反応がほとんどなく、創傷部、特に創面と
のなじみが良好で、さらに、生体からの滲出物により創
傷被覆材1が創面に固着することがないようにするため
である。The support layer 3 is formed of a thin film of a biocompatible high water content gel-forming substance. The reason why a biocompatible material is used is that when the wound dressing material 1 is applied to a wound, there is almost no foreign body reaction by the living body, it blends well with the wound, especially the wound surface, and it is also free from living organisms. This is to prevent the wound dressing 1 from sticking to the wound surface due to exudates.
このような、生体適合性高含水ゲル形成性物質としては
、カルボキンメチルセルロース、アルギン酸ナトリウム
等のアルキン酸塩系、ヒアルロン酸ナトリウム等のヒア
ルロン酸塩系、メタアクリル酸ナトリウム等のポリ (
メタ)アクリル酸塩系、キトサン誘導体、キチン誘導体
などの高分子側鎖にカルホキシル基を有するものが好適
に使用できる。具体的には、上記のような高分子側鎖に
カルホキシル基を有する生体適合性高含水ゲル形成性物
質により不織布、織布、編布または多孔質膜状に形成さ
れたものが好適に使用される。そして、生体適合性を有
する高含水ゲル形成性物質薄膜により形成された支持層
は、水分保持、吸水性を持つことにより、浸出液の適度
の貯留機能と創面への良好密着性かつ非癒着性を有し、
この性質および上記材質の持つ生体に不活性な性質によ
り疼痛抑制作用を有する。このため、高含水状態による
適正な生体環境か維持され、治癒、特に表皮再生が促進
され、さらに、創面への良好な密着性を有することによ
り、細菌の創面への侵入を抑制する。Such biocompatible high water-containing gel-forming substances include carboquine methylcellulose, alkinate-based substances such as sodium alginate, hyaluronate-based substances such as sodium hyaluronate, and poly(
Polymers having carboxyl groups in their side chains, such as meth)acrylates, chitosan derivatives, and chitin derivatives, can be suitably used. Specifically, a nonwoven fabric, a woven fabric, a knitted fabric, or a porous membrane formed from a biocompatible high water content gel-forming substance having a carboxyl group in the polymer side chain as described above is preferably used. Ru. The support layer, which is made of a thin film of a highly hydrous gel-forming material that is biocompatible, has water retention and water absorption properties, and has a moderate exudate retention function and good adhesion and non-adhesion to the wound surface. have,
Due to this property and the inert property of the above-mentioned material to living organisms, it has a pain suppressing effect. Therefore, a suitable biological environment with a high water content is maintained, healing, especially epidermal regeneration is promoted, and furthermore, by having good adhesion to the wound surface, it suppresses the invasion of bacteria into the wound surface.
さらに、本発明の創傷被覆材では、Ca ”Z n ”
Cu ” A l 3° T i ”等の二価以
上の金属イオンが、支持層3を形成する高含水ゲル形成
性物質が有する複数のカルボキシル基と結合しており、
部分的に配位架橋した部分架橋1F合体を形成している
。このため、高含水ゲル形成物質は、含水状態において
も、分子レベルでの安定性か高く、使用時における高含
水ゲル形成性物質の分解、溶出か抑制される。Furthermore, in the wound dressing of the present invention, Ca “Z n ”
A divalent or higher metal ion such as Cu ``Al 3° Ti'' is bonded to a plurality of carboxyl groups of the high hydrous gel-forming substance forming the support layer 3,
A partially crosslinked 1F combination is formed which is partially coordinately crosslinked. Therefore, the highly hydrous gel-forming substance has high stability at the molecular level even in a water-containing state, and decomposition and elution of the highly hydrous gel-forming substance during use are suppressed.
この2価以上の金属による架橋の程度(高含水ケル形成
性物質中の全カルホキシル基中における2価以上の金属
と結合しているカルホキシル基の率)は、50〜100
%程度が好ましい。50%以上であれば、十分な使用時
における高含水ゲル形成性物質の分解、溶出を確実に抑
制でき、好ましい。より好ましくは、75〜100%で
ある。The degree of crosslinking by this metal with a valence of 2 or more (ratio of carboxyl groups bonded to a metal with a valence of 2 or more among all carboxyl groups in the high water content Kel-forming substance) is 50 to 100.
% is preferable. If it is 50% or more, decomposition and elution of the highly hydrous gel-forming substance can be reliably suppressed during sufficient use, which is preferable. More preferably, it is 75 to 100%.
また、支持層3中に導入される2価以上の金属としては
、Ca、Zn、Cu、AI、Ti等の金属が好ましく、
またこれらのうち1種のものに限定されるものではなく
、上記の金属の重複数のものを用いてもよい。そして、
支持層3、ひいては、創傷被覆材1として、抗菌性を有
するものとする場合には、Zn、Cuなどを用いること
が好ましく、より広い抗菌スペクトルを有するものとす
るためには、Z n % Cuなどを含む、複数の金属
を用いることが好ましい。Further, as the metal having a valence of more than 2 to be introduced into the support layer 3, metals such as Ca, Zn, Cu, AI, and Ti are preferable.
Further, the material is not limited to one of these metals, and a plurality of the above-mentioned metals may be used. and,
When the support layer 3 and, by extension, the wound dressing 1 are to have antibacterial properties, it is preferable to use Zn, Cu, etc. In order to have a wider antibacterial spectrum, Zn%Cu It is preferable to use a plurality of metals, including, for example.
さらに、創傷被覆材として、Zn、Cuなどが有する抗
菌作用より、さらに高い抗菌作用を有するものとするた
めに、銀を高含水ゲル形成性支持層に導入すること(一
部のカルボキシル基に銀を結合させること)が好ましい
。このようにすることにより、創傷部の治癒とともに、
創傷部における細菌の増殖、さらには、外部からの細菌
の感染を阻止ことが可能となる。Furthermore, in order to make the wound dressing material have an antibacterial effect even higher than that of Zn, Cu, etc., it is necessary to introduce silver into the highly hydrogel-forming support layer (some carboxyl groups contain silver). ) is preferred. By doing this, as the wound heals,
It becomes possible to prevent the proliferation of bacteria in the wound area and furthermore to prevent bacterial infection from the outside.
さらに、上記の高含水ゲル形成性物質薄膜により形成さ
れた支持層3は、創傷部に接触し得る部位の少なくとも
一部が撥水性物質2により被覆されている。撥水性物質
により被覆するのは、高含水ゲル形成性物質薄膜により
形成された支持層3が有している空隙を補填することに
より、支持層のほつれ、剥離等に対する補強、支持の役
割を果たすとともに、支持層3が、創傷部の滲出物を極
端に吸収することを抑制し、適度に吸収させるようにす
るためである。また支持層3を撥水性物質により被覆す
ることにより水分透過調節層との接着性が向上する。Further, in the support layer 3 formed of the above-mentioned thin film of the highly hydrous gel-forming substance, at least a portion of the part that can come into contact with the wound part is covered with the water-repellent substance 2. The coating with the water-repellent material serves to strengthen and support the support layer against fraying, peeling, etc. by filling in the voids in the support layer 3 formed of the thin film of the highly hydrous gel-forming material. At the same time, this is to prevent the support layer 3 from excessively absorbing exudate from the wound area, and to allow the exudate to be absorbed appropriately. Furthermore, by coating the support layer 3 with a water-repellent substance, the adhesion with the water permeation regulating layer is improved.
そして、撥水性物質2としては、生体適合性を有するも
のを用いることが好ましい。As the water-repellent substance 2, it is preferable to use a substance that is biocompatible.
そのような、撥水性物質2としては、シリコーン、ポリ
ウレタン、スチレン−ブタジエン−スチレンブロックコ
ポリマー ポリテトラフルオロエチレンなどが好適に使
用でき、特に、好ましくは、シリコーンエラストマー、
セグメント化ポリウレタンである。As such water-repellent material 2, silicone, polyurethane, styrene-butadiene-styrene block copolymer, polytetrafluoroethylene, etc. can be suitably used, and particularly preferably, silicone elastomer,
It is a segmented polyurethane.
そして、この撥水性物質を被覆した状態の支持層3は、
50〜500重量%の吸水能を有していることが好まし
い。より、好ましくは、100〜300重量%の吸水能
を有していることである。The support layer 3 coated with this water-repellent material is
It is preferable to have a water absorption capacity of 50 to 500% by weight. More preferably, it has a water absorption capacity of 100 to 300% by weight.
そして、支持層3の創傷部に接触し得る部位とは反対側
には、水分透過調節層4が形成されている。A moisture permeation regulating layer 4 is formed on the opposite side of the support layer 3 from the part that can come into contact with the wound.
この水分透過調節層4は、創面での適性な水分保持状態
を維持するためのものであり、使用時において下層とな
る支持層3の高含水ゲル状態を確保し、かつ水蒸気は透
過させるが、滲出液中のタンパク質成分の外部への露出
を防止するため、創傷部の生体組織の修復に好ましい環
境を与える。この水分透過調節層4の形成材料としては
、水蒸気透過性樹脂薄膜により形成されており、具体的
には、シリコーンエラストマーポリウレタンエラストマ
ーなどの薄膜、さらには、適度な水分透過性を有する疎
水性の多孔質膜(例えば、ポリプロピレン多孔質膜、ポ
リエチレン多孔質膜)などが好適に使用できる。前述の
ように支持層3自体が抗菌性を有しているものとすれば
、この水分透過調節層4の水蒸気透過率(JIS規格)
は、比較的広範囲に設定することが可能であるが、0.
1〜500 m9/cx”・hr、より好ましくは0.
1〜200R9/cII″・hrであることが好ましい
。This moisture permeation control layer 4 is for maintaining an appropriate moisture retention state on the wound surface, and it ensures that the underlying support layer 3 is in a high water content gel state during use, and allows water vapor to pass through. In order to prevent the protein components in the exudate from being exposed to the outside, a favorable environment is provided for the repair of living tissue at the wound site. The material for forming the moisture permeation regulating layer 4 is a water vapor permeable resin thin film, and specifically, a thin film such as silicone elastomer or polyurethane elastomer, or a hydrophobic porous film having appropriate moisture permeability. A membrane such as a porous polypropylene membrane or a porous polyethylene membrane can be suitably used. Assuming that the support layer 3 itself has antibacterial properties as described above, the water vapor permeability of this moisture permeation control layer 4 (JIS standard)
can be set over a relatively wide range, but 0.
1 to 500 m9/cx”・hr, more preferably 0.
It is preferably 1 to 200R9/cII''·hr.
次に、本発明の創傷被覆材の製造方法について説明する
。Next, a method for manufacturing the wound dressing of the present invention will be explained.
この実施例の創傷被覆材の製造方法は、まず生体適合性
を有する高含水ゲル形成性物質薄膜を形成または準備し
、この高含水ゲル形成性物質薄膜の少な(とも一方の面
に撥水性物質溶液を接触させ乾燥させる。そして、撥水
性物質が部分的に被覆された高含水ゲル形成性物質薄膜
を2価以上の金属イオンを含有する溶液に接触させ乾燥
させる。次いで、この高含水ゲル形成性物質薄膜の他方
の面を、薄膜状に形成され未硬化かつ粘着性を有する状
態の水分透過性薄膜形成性物質の上に載置し、その後水
分透過性薄膜形成性物質を硬化させるものである。The method for manufacturing the wound dressing of this example involves first forming or preparing a thin film of a highly hydrous gel-forming substance that is biocompatible, and adding a small amount of a water-repellent substance to one side of this thin film of a highly hydrous gel-forming substance. The solution is brought into contact and dried.Then, a thin film of a highly hydrous gel-forming material partially coated with a water-repellent material is brought into contact with a solution containing divalent or higher valent metal ions and dried.Then, this highly hydrous gel is formed. The other side of the thin film of a transparent substance is placed on a water-permeable thin film-forming material that is formed into a thin film, uncured and sticky, and then the water-permeable thin film-forming material is cured. be.
具体的には、カルボキシメチルセルロース系、アルギン
酸塩系、ヒアルロン酸塩系、ポリ(メタ)アクリル酸塩
系、キトサン誘導体、キチン誘導体などの高分子側鎖に
カルボキシル基を有するものちを用いて、不織布、織布
、編布、多孔質膜などにより、高含水ゲル形成性物質薄
膜を作成する。そして、上記のように作成された高含水
ゲル形成性物質薄膜を溶解しない適当な溶媒、例えば、
ヘキサン、テトラヒドロフラン、メチルエチルケトンに
、撥水性物質、例えば、シリコーン、ポリウレタン、ス
チレン−ブタジエン−スチレンブロックコポリマー ポ
リテトラフルオロエチレンを濃度1〜10重量%程度溶
解した撥水性物質溶液を作成し、高含水ゲル形成性物質
薄膜をこの溶液に浸漬、またはスプレー ローラーなど
を用いて塗布することにより接触させ、高含水ゲル形成
性物質薄膜の創傷部と接触する部分となる面の少なくと
も一部に撥水性物質を付着させ、乾燥させる。次に、こ
の撥水性物質が付着された高含水ゲル形成性物質薄膜を
2価以上金属イオン(例えば、Ca ”Z n ”
Cu ” A I ”″、Ti4°)を0.1〜5.
0%程度含有する液体(例えば、塩化カルシウム水溶液
、塩化亜鉛、硝酸亜鉛、硝酸銅等)に浸漬、またはスプ
レー ローラーなどを用いて塗布することにより接触さ
せ、乾燥させることにより、高含水ゲル形成性物質薄膜
のカルボキシル基と金属イオンを結合させことにより、
基材層3が形成される。Specifically, nonwoven fabrics are produced using polymers with carboxyl groups in their side chains, such as carboxymethyl cellulose, alginate, hyaluronate, poly(meth)acrylate, chitosan derivatives, and chitin derivatives. A thin film of a highly hydrous gel-forming substance is created using woven fabric, knitted fabric, porous membrane, etc. Then, a suitable solvent that does not dissolve the thin film of the highly hydrogel-forming substance prepared as described above, for example,
A water repellent material solution is prepared by dissolving a water repellent material such as silicone, polyurethane, styrene-butadiene-styrene block copolymer, polytetrafluoroethylene in hexane, tetrahydrofuran, or methyl ethyl ketone at a concentration of 1 to 10% by weight to form a high water content gel. A thin film of the highly hydrophobic gel-forming substance is brought into contact with this solution by dipping it or applying it using a spray roller, and the water-repellent substance is attached to at least part of the surface of the thin film of the highly hydrous gel-forming substance that will come into contact with the wound area. Let it dry. Next, the thin film of the highly water-containing gel-forming material to which the water-repellent material has been attached is treated with metal ions of divalent or higher valence (e.g., Ca "Z n ").
Cu ``A I '''', Ti 4°) from 0.1 to 5.
Highly hydrous gel-forming properties can be obtained by immersion in a liquid containing approximately 0% calcium chloride (e.g., aqueous calcium chloride solution, zinc chloride, zinc nitrate, copper nitrate, etc.) or by applying it with a spray roller and drying. By combining carboxyl groups in a thin film of material with metal ions,
A base material layer 3 is formed.
なお支持層を撥水性物質により被覆する前に、金属イオ
ンによる部分架橋処理を施してもよいが、支持層の形態
保持の面から撥水性物質により被覆した後に、部分架橋
処理を施すことが好ましい。Note that before coating the support layer with a water-repellent substance, partial cross-linking treatment with metal ions may be performed, but from the viewpoint of maintaining the shape of the support layer, it is preferable to perform partial cross-linking treatment after coating with a water-repellent substance. .
そして、平板基材上に、適当な溶媒、例えば、ヘキサン
、テトラヒドロフラン、メチルエチルケトンに、濃度5
0〜70重量%程度に添加された水分透過性薄膜形成性
物質(例えば、硬化後にシリコーンエラストマー ポリ
ウレタンエラストマーとなる物質)の溶液を精密被覆用
具(アプリケータ)を用いて塗布し、塗布した直後(硬
化前であって粘着性を有する状態)に、この水分透過性
薄膜形成性物質溶液の上に上述の撥水性物質の付着、2
価以上の金属が導入された基材層を載せ、硬化させるこ
とにより本発明の創傷被覆材が作成される。また、この
創傷被覆材が、抗菌性が高いものとするためには、上述
の2価以上金属イオン含有液体との接触処理の前後に、
銀イオンを濃度0.1〜50重量%程度含有する液体(
例えば、硝酸銀水溶液)に接触させることにより、高含
水ゲル形成性物質中の一部のカルボキシル基に銀を結合
させことにより、基材層に銀を導入させる。また、2価
以上の金属イオン含有液体中に銀イオン含有液体(例え
ば、硝酸銀水溶液)を添加して、2価以上の金属と銀と
を同時に高含水ゲル形成性物質のカルボキシル基と結合
させるようにしてもよい。Then, on a flat plate substrate, a suitable solvent such as hexane, tetrahydrofuran, methyl ethyl ketone is added at a concentration of 5.
Immediately after applying a solution of a water-permeable thin film-forming substance (for example, a substance that becomes silicone elastomer or polyurethane elastomer after curing) added to about 0 to 70% by weight using a precision coating tool (applicator), (2) attaching the above-mentioned water-repellent substance on the water-permeable thin film-forming substance solution before curing (in a sticky state);
The wound dressing of the present invention is prepared by placing a base material layer into which a metal of higher than the valence is introduced and curing it. In addition, in order for this wound dressing to have high antibacterial properties, it is necessary to
A liquid containing silver ions in a concentration of about 0.1 to 50% by weight (
For example, silver is introduced into the base material layer by bonding the silver to some carboxyl groups in the highly hydrous gel-forming substance by bringing it into contact with an aqueous silver nitrate solution. In addition, a liquid containing silver ions (for example, an aqueous solution of silver nitrate) is added to a liquid containing metal ions with a valence of 2 or more, so that the metal with a valence of 2 or more and silver are simultaneously combined with the carboxyl group of the highly hydrogel-forming substance. You may also do so.
[実施例]
以下、本発明の実施例を図面を参照して具体的に説明す
る。[Example] Hereinafter, an example of the present invention will be specifically described with reference to the drawings.
(実施例1)
市販のカルボキンメチルセルロースナトリウム塩製の不
織布(旭化成株式会社製、エーテル化度0.25)を5
%のメディカルグレードサイラスティックス■−シリコ
ーン(接着シリコーンタイプA5ダウコーニング株式会
社製)のヘキサン溶液中にlO秒間rlJIし、クリー
ンベンチ内に放置し乾燥させた後、この不織布を1%塩
化カルシウム溶液に10秒浸漬し、水洗を行い、クリー
ンベンチ内に放置し、十分乾燥させた。(Example 1) A commercially available nonwoven fabric made of carboquine methylcellulose sodium salt (manufactured by Asahi Kasei Corporation, degree of etherification 0.25) was
% Medical Grade Silastics ■-Silicone (adhesive silicone type A5 manufactured by Dow Corning) in a hexane solution for 10 seconds, left to dry on a clean bench, and then soaked in a 1% calcium chloride solution. The sample was immersed in water for 10 seconds, washed with water, and left in a clean bench to dry thoroughly.
次にテフロン平板上に67%のメディカルグレートサイ
ラスティックス@シリコーン(接着シリコーンタイプA
、タウコーニング株式会社製)、のヘキサン溶液を精密
被覆用具(アプリケータ)を用いて塗布し製膜し、塗布
した直後に、その7Sli!潤層上に上記の不織布を載
せ、室温で10分間放置した後、60°Cで少なくとも
1時間、オーブンで硬化させて、本発明の創傷被覆材を
得た。Next, 67% Medical Great Silastics@Silicone (adhesive silicone type A) was placed on a Teflon plate.
, manufactured by Tau Corning Co., Ltd.) using a precision coating tool (applicator) to form a film, and immediately after coating, the 7Sli! The above-mentioned nonwoven fabric was placed on the wet layer, left to stand at room temperature for 10 minutes, and then cured in an oven at 60°C for at least 1 hour to obtain a wound dressing of the present invention.
(実施例2)
市販のカルボキンメチルセルロースナトリウム塩製の不
織布(旭化成株式会社製、エーテル化度0.25)を5
%のメディカルグレードサイラスティックス0−シリコ
ーン(接着シリコーンタイプA、ダウコーニング株式会
社製)のへ牛サン溶液中に10秒間’&?fAし、クリ
ーンベンチ内に放置し乾燥させた後、この不織布を1%
塩化カルシウム溶液に10秒浸漬し、水洗を行い、クリ
ーンベンチ内に放置し、乾燥させ、そして、この不織布
を1%硝酸銀(アンモニア性)溶液に30秒間浸漬し、
水洗を行い、クリーンベンチ内に放置し、乾燥させた。(Example 2) A commercially available nonwoven fabric made of carboquine methyl cellulose sodium salt (manufactured by Asahi Kasei Corporation, degree of etherification 0.25) was
% of Medical Grade Silastics 0-Silicone (Adhesive Silicone Type A, manufactured by Dow Corning Corporation) was placed in a bovine solution for 10 seconds. fA, leave it in a clean bench to dry, and then apply 1%
The nonwoven fabric was immersed in a calcium chloride solution for 10 seconds, washed with water, left in a clean bench, and dried, and the nonwoven fabric was immersed in a 1% silver nitrate (ammoniac) solution for 30 seconds.
It was washed with water and left in a clean bench to dry.
次に、テフロン平板上に67%のメディカルグレードサ
イラスティックス■ンリフーン(接着シリコーンタイプ
A1ダウコーニング株式会社製)のヘキサン溶液を精密
被覆用具(アプリケータ)を用いて塗布し製膜し、塗布
した直後に、その湿潤層上に上記の不織布を載せ、室温
で10分間放置した後、60℃で少なくとも1時間、オ
ーブンで硬化させて、本発明の創傷被覆材を得た。Next, a hexane solution of 67% medical grade silastics (adhesive silicone type A1 manufactured by Dow Corning Co., Ltd.) was applied onto the Teflon plate using a precision coating tool (applicator) to form a film. Immediately thereafter, the above-mentioned nonwoven fabric was placed on the wet layer, left to stand at room temperature for 10 minutes, and then cured in an oven at 60° C. for at least 1 hour to obtain the wound dressing of the present invention.
(比較例1)
市販のカルボキシメチルセルロースナトリウム塩製(旭
化成株式会社製、エーテル化度025)の不織布を1%
のメディカルグレードサイラスティックス■−シリコー
ン(接着シリコーンタイプA、ダウコーニング株式会社
製)のヘキサン溶液中に10秒間浸漬し、クリーンベン
チ内でし乾燥させた。次に、テフロン平板上に67%の
メディカルグレードサイラスティックスOシリコーン(
接着シリコーンタイプA1ダウコーニング株式会社製)
のヘキサン溶液を精密被覆用具(アプリケータ)を用い
て塗布し製膜し、塗布した直後に、その湿潤層上に上記
の不織布を載せ、室温で10分間放置した後、60’C
で少なくとも1時間、オーブンで硬化させて、比較例の
創傷被覆材を得た。(Comparative Example 1) 1% of commercially available nonwoven fabric made of carboxymethylcellulose sodium salt (manufactured by Asahi Kasei Corporation, degree of etherification 025)
The sample was immersed for 10 seconds in a hexane solution of Medical Grade Silastics ■-Silicone (adhesive silicone type A, manufactured by Dow Corning Corporation) and dried in a clean bench. Next, 67% medical grade Silastics O silicone (
Adhesive silicone type A1 manufactured by Dow Corning Corporation)
Immediately after coating, the above-mentioned nonwoven fabric was placed on the wet layer, left at room temperature for 10 minutes, and heated at 60'C.
A comparative wound dressing was obtained by curing in an oven for at least 1 hour.
(比較例2〜4)
比較例2〜4として、市販のコラーゲン処理を施したナ
イロンメツシュとシリコーン膜よりなる複合膜(woo
droof株式会社製、Biobrane’比較例2)
、キチン不織布(ユニチカ社株式会社製、ベスキチンW
・、比較例3)およびコラーゲン不織布(明治製菓株式
会社製、メイバ・ツク・、比較例4)を用いた。(Comparative Examples 2 to 4) As Comparative Examples 2 to 4, composite membranes (woo
Made by droof Co., Ltd., Biobrane' Comparative Example 2)
, chitin nonwoven fabric (manufactured by Unitika Co., Ltd., Beschitin W)
*, Comparative Example 3) and a collagen nonwoven fabric (Meiba Tsuku, manufactured by Meiji Seika Co., Ltd., Comparative Example 4) were used.
[実験コ
そして、上記の実施例1および2.比較例1ないし4の
創傷被覆材を用いて以下の実験を行った。[Experiments and Examples 1 and 2 above. The following experiments were conducted using the wound dressings of Comparative Examples 1 to 4.
(実験1:動物実験による評価)
日本白色兎(体重2.5〜3.0に9’)の背部を刺毛
後、背部皮膚に剥皮具(デルマトーム)を用いて、2C
農X2c*の大きさ、深さ5 / 100インチの創傷
部を4カ所作製し、止血後、実施例1および2、比較例
1ないし4のそれぞれの創傷被覆材を創傷部に載せ、そ
の上に非癒着性被覆材(プリマボア@ 、Sm1th
& Nephew Inc、製)を載せて、その上を更
に伸縮性のインサイズドレープ(Steri−Drap
e@ スリーエム株式会社製)で覆った後、伸縮テー
プを用いて固定し、自由給水、自由給餌で飼育した。3
日、7日、14日後にそれぞれ麻酔層殺し、以下の項目
についての評価を行った。(Experiment 1: Evaluation by animal experiment) After pricking the back of a Japanese white rabbit (body weight 2.5 to 3.0 cm), the back skin was treated with 2C using a peeling tool (dermatome).
Four wounds of size X2c* and depth of 5/100 inches were created, and after stopping the bleeding, the wound dressings of Examples 1 and 2 and Comparative Examples 1 to 4 were placed on the wounds. Non-adhesive dressing (Primavore @, Sm1th
& Nephew Inc.), and then an elastic in-size drape (Steri-Drap) on top.
The mice were covered with a plastic wrapper (manufactured by 3M Co., Ltd.), fixed using elastic tape, and reared with free access to water and food. 3
After 1 day, 7 days, and 14 days, the animals were anesthetized and the following items were evaluated.
(1)表皮化率
創傷部作製後3日経過した創面より異なる2ケ所をサン
プリングし、組織標本を作製し、組織の光学顕微鏡写真
を倍率18倍で連続的に撮影して、表皮部の長さを測定
して、欠損部の長さとの比を%で表した。(1) Epidermis conversion rate Sample two different locations on the wound surface 3 days after wound preparation, prepare tissue specimens, and take continuous optical micrographs of the tissue at 18x magnification to determine the length of the epidermis. The length was measured and the ratio to the length of the defect was expressed as a percentage.
(2)表皮厚
創傷部作製後14日経過した各創面より異なる2ケ所を
サンプリングし、組織標本を作製し、組織を光学顕微鏡
写真率360倍で観察しながら測微接眼レンズで5ケ所
の表皮部についてその厚さを測定した。(2) Epidermal Thickness 14 days have passed since wound preparation, sample two different locations from each wound surface, prepare tissue specimens, and observe the tissue at 360x optical microscope photography while observing the epidermis at 5 locations with a microscopic eyepiece. The thickness of each part was measured.
(3)検体(創傷被覆材の形成材料)の脱落創傷部作製
後、3日、7日、14日経過した各創面より異なる2ケ
所をサンプリングし、組織標本を作製し、組織を病理検
索に付し、検体(創傷被覆材の形成材料)の脱落・組織
への取り込みを調べた。(3) After the specimen (material for forming the wound dressing) fell off. After 3 days, 7 days, and 14 days had passed after the preparation of the wound, two different locations were sampled from each wound surface, tissue specimens were prepared, and the tissues were used for pathological examination. The specimen (material for forming the wound dressing) was examined for shedding and incorporation into the tissue.
なお、評価値は以下の基準によった。Note that the evaluation value was based on the following criteria.
−二脱落なし、±ニ一部脱落表皮部へ取り込み、+:全
全層脱落表皮へ取り込み、
++:+と同等、表皮化阻害、
十++:真皮部へ取り込み、表皮化を阻害(4)組織反
応
創傷部作製後、3日、7日、14日経過した各創傷面よ
り異なる2ケ所をサンプリングし、組織標本を作製し、
組織を病理検索に付し、組織の検体に対する炎症性・異
物性反応を調べた。-2: No shedding, ±2: Partially shed and absorbed into the epidermis, +: Full thickness taken into the epidermis, ++: Equivalent to +, inhibition of epidermalization, 10++: Incorporated into the dermis, inhibiting epidermalization (4) Tissue reaction Two different locations were sampled from each wound surface 3, 7, and 14 days after wound preparation, and tissue specimens were prepared.
The tissues were subjected to pathological examination to examine inflammatory and foreign body reactions to the tissue specimens.
なお、評価は以下の基準によった。The evaluation was based on the following criteria.
−:反応全くなし、 ±:軽微な反応
++;中等度な反応、+++−重度な反応以上の項目に
ついて得られた結果を第1表に示す。-: No reaction at all, ±: Minor reaction ++: Moderate reaction, +++ - Severe reaction or higher, the results obtained for the items are shown in Table 1.
第1表
上記結果より、実施例1および実施例2は、良好な表皮
再生と肥圧の防止作用を有し、さらに、検体(創傷被覆
材の形成材料)の脱落の抑制および組織反応の低減等の
効果を有することが確認された。From the above results in Table 1, Examples 1 and 2 have good epidermal regeneration and antihypertensive effects, and also suppress the falling off of the specimen (material for forming the wound dressing) and reduce tissue reaction. It was confirmed that it has the following effects.
(実験2:抗菌性試験)
抗菌済シャーレ上に固形培地(MLlller Hin
tonAgarSMHA、 Difco製)を20*Q
/シヤーレの割合でまき、平板とし、前培養されたPs
eudomonasaeruginusa (緑膿菌)
、Esherichia coil (大腸菌) 、
5taphylococcus aureus (黄色
ブドウ球菌) %5taphylococcus ep
idesidis (表皮ブドウ球菌)を均一に塗抹し
た。これに実施例2と比較例1の被覆材を直径1cmの
円形に切ってサンプルとし、固定培地平板1枚あたり3
ケ所載せた。37°Cて18時間倒置培養後、阻止円の
有無、不織布接触面での菌の発育を観察した。(Experiment 2: Antibacterial test) A solid medium (MLller Hin) was placed on an antibacterial petri dish.
tonAgarSMHA, manufactured by Difco) at 20*Q
Ps sown, plated and pre-cultured at a ratio of
eudomonasaeruginusa (Pseudomonas aeruginosa)
, Escherichia coil (E. coli),
5taphylococcus aureus (Staphylococcus aureus) %5taphylococcus ep
idesidis (Staphylococcus epidermidis) was evenly smeared. In addition, the coating materials of Example 2 and Comparative Example 1 were cut into circular pieces with a diameter of 1 cm to prepare samples.
I posted a few places. After 18 hours of inverted culture at 37°C, the presence or absence of an inhibition zone and the growth of bacteria on the contact surface of the nonwoven fabric were observed.
結果は、第2表に示す通りであった。The results were as shown in Table 2.
第2表
表中の−は、阻止円なく、接触面でも菌が発育したもの
を示しており、+は、阻止円が認めたものを示している
。In Table 2, - indicates that bacteria grew even on the contact surface without an inhibition circle, and + indicates that an inhibition circle was observed.
上記結果より、実施例2の抗菌効果が確認された。From the above results, the antibacterial effect of Example 2 was confirmed.
[発明の効果]
本発明の創傷被覆材は、創傷部に接触し得る部位の少な
くとも一部が撥水性物質により被覆された生体適合性を
有する高含水ゲル形成性物質薄膜により形成された支持
層と、支持層の創傷部に接触し得る部位とは反対側に形
成された水分透過調節層とからなり、支持層を形成する
高含水ゲル形成性物質は、カルボキシル基を有するとと
もに複数のカルボキシル基と結合した2価以上の金属を
有しているものであるので、熱傷、裸皮創および皮膚剥
削側、外傷性皮膚欠損側等の疾患ないし創傷による幹部
に適用された際に、適当な水蒸気透過性と滲出液吸収性
を有するために創面を適度な保湿状態下に保ちつつ密着
して感染、痛みを防ぎ、また創面との接触部位は生体適
合性を有するので、生体による異物反応が起きたり、該
被覆材が創面に固着してしまい剥離時に出血、痛み等を
伴うといったことも起こらず、上記したように適度な保
湿状態下に創面を保つことと相乗して、創傷部の治癒を
促進しかつ廚痕を残すことなくきれいに再生する。さら
に、本発明の創傷被覆材は、上記のように、支持層が、
カルボキシル基を有する生体適合性高含水ゲル形成性物
質により形成され、さらに、複数のカルボキシル基と結
合した2価以上の金属を有しているため、支持層が生体
適合性かつ高含水ゲル形成性という性質を有した状態で
、2価以上の金属により部分的に配位架橋されているた
め、支持層として強固となっており、このため支持層を
形成する物質が容易に分解、離脱することがなく、支持
層が水分を吸収した際における支持層形成物質の分解、
破断等に伴う被覆材の一部の生体内への脱落を防止する
作用を有する。[Effects of the Invention] The wound dressing of the present invention includes a support layer formed of a thin film of a biocompatible high water content gel-forming material, in which at least a portion of the part that can come into contact with the wound is covered with a water-repellent material. and a moisture permeation regulating layer formed on the opposite side of the supporting layer from the part that can come into contact with the wound, and the high hydrogel forming substance forming the supporting layer has a carboxyl group and a plurality of carboxyl groups. Since it has a divalent or higher valent metal combined with a metal, it can be applied to the trunk due to diseases or wounds such as burns, bare skin wounds, skin abrasion side, traumatic skin defect side, etc. Because it has permeability and exudate absorption properties, it keeps the wound surface in an appropriate moisturized state and adheres closely to prevent infection and pain, and the site of contact with the wound surface is biocompatible, so a foreign body reaction by living organisms can occur. It also prevents the dressing from sticking to the wound surface and causing bleeding, pain, etc. when it is removed, and in combination with keeping the wound surface under an appropriate moisturizing condition as mentioned above, promotes healing of the wound area. Promote and cleanly regenerate without leaving any scars. Furthermore, as described above, the wound dressing of the present invention has a support layer comprising:
The support layer is made of a biocompatible high-hydrogel-forming substance having a carboxyl group, and further contains a divalent or higher-valent metal bonded to multiple carboxyl groups, making the support layer biocompatible and highly hydrogel-forming. Because it has the property of being partially coordinately cross-linked with divalent or higher valent metals, it becomes strong as a support layer, and therefore the substance forming the support layer easily decomposes and separates. decomposition of the material forming the support layer when the support layer absorbs moisture;
It has the effect of preventing part of the dressing from falling into the body due to breakage, etc.
また、本発明の創傷被覆材の製造方法は、生体適合性を
有する高含水ゲル形成性物質薄膜を形成あるいは準備し
、該高含水ゲル形成性物質薄膜の少なくとも一方の面に
撥水性物質溶液を接触させ乾燥させた後、該高含水ゲル
形成性物質薄膜を2価以上の金属イオンを含有する溶液
に接触させ乾燥させ、そして、薄膜状に形成され未硬化
かつ粘着性を有する状態の水分透過性薄膜形成性物質の
上に、前記高含水ゲル形成性物質薄膜の他方の面を載置
し、その後肢水分透過性薄膜形成性物質を硬化させるも
のであるので、上述のような優れた機能を有する創傷被
覆材を容易かつ確実に作成することができる。Further, the method for producing a wound dressing of the present invention includes forming or preparing a thin film of a highly hydrous gel-forming substance having biocompatibility, and applying a water-repellent substance solution to at least one surface of the thin film of the highly hydrous gel-forming substance. After contacting and drying, the thin film of the highly hydrous gel-forming substance is brought into contact with a solution containing divalent or higher valence metal ions and dried, and the water permeation in the uncured and sticky state is formed into a thin film. The other side of the high water content gel-forming material thin film is placed on the hindlimb water-permeable thin film-forming material, and the hindlimb water-permeable thin film-forming material is cured. It is possible to easily and reliably create a wound dressing having the following properties.
第1図は、本発明の創傷被覆材の実施態様の微細構造を
示す拡大断面回出ある。
l・・・創傷被覆材
2・・・撥水性物質
3・・・支持層
4・・・水分透過調節層FIG. 1 is an enlarged cross-sectional view showing the microstructure of an embodiment of the wound dressing of the present invention. l...Wound dressing material 2...Water repellent substance 3...Support layer 4...Moisture permeation regulating layer
Claims (11)
性物質により被覆された生体適合性を有する高含水ゲル
形成性物質薄膜により形成された支持層と、該支持層の
創傷部に接触し得る部位とは反対側に形成された水分透
過調節層とからなり、前記高含水ゲル形成性物質は、カ
ルボキシル基を有するとともに複数のカルボキシル基と
結合した2価以上の金属を有していることを特徴とする
創傷被覆材。(1) A support layer formed of a thin film of a biocompatible high water-containing gel-forming material, at least a portion of which can come into contact with the wound, is covered with a water-repellent material, and the support layer contacts the wound. and a moisture permeation regulating layer formed on the opposite side of the gel-forming material, and the high water content gel-forming material has a carboxyl group and a divalent or higher valent metal bonded to a plurality of carboxyl groups. A wound dressing characterized by:
記載の創傷被覆材。(2) The wound dressing according to claim 1, wherein the metal has antibacterial properties.
キシメチルセルロース系、アルギン酸塩系、ヒアルロン
酸塩系、ポリ(メタ)アクリル酸塩系、キトサン誘導体
、キチン誘導体からなる群より選ばれたものである請求
項1または2に記載の創傷被覆材。(3) The biocompatible high water content gel-forming substance is selected from the group consisting of carboxymethyl cellulose, alginate, hyaluronate, poly(meth)acrylate, chitosan derivatives, and chitin derivatives. The wound dressing according to claim 1 or 2.
、編布または多孔質膜である請求項1ないし3に記載の
創傷被覆材。(4) The wound dressing material according to any one of claims 1 to 3, wherein the thin film of the highly hydrous gel-forming substance is a nonwoven fabric, a woven fabric, a knitted fabric, or a porous membrane.
スチレン−ブタジエン−スチレンブロックコポリマーお
よびポリテトラフルオロエチレンからなる群から選ばれ
たものである請求項1ないし4のいずれかに記載の創傷
被覆材。(5) The water repellent material may include silicone, polyurethane,
A wound dressing according to any one of claims 1 to 4, which is selected from the group consisting of styrene-butadiene-styrene block copolymers and polytetrafluoroethylene.
基には、銀が結合している請求項1ないし5のいずれか
に記載の創傷被覆材。(6) The wound dressing material according to any one of claims 1 to 5, wherein silver is bonded to some carboxyl groups of the high water content gel-forming substance.
より形成されている請求項1ないし6のいずれかに記載
の創傷被覆材。(7) The wound dressing material according to any one of claims 1 to 6, wherein the moisture permeation regulating layer is formed of a water vapor permeable resin thin film.
トマー薄膜またはポリウレタンエラストマー薄膜である
請求項7に記載の創傷被覆材。(8) The wound dressing according to claim 7, wherein the water vapor permeable resin thin film is a silicone elastomer thin film or a polyurethane elastomer thin film.
、0.1〜500mg/cm^2・hrである請求項1
ないし8項のいずれかに記載の創傷被覆材。(9) Claim 1, wherein the water vapor permeability (JIS standard) of the wound dressing is 0.1 to 500 mg/cm^2·hr.
The wound dressing material according to any one of items 1 to 8.
%である請求項1ないし9項のいずれかに記載の創傷被
覆材。(10) The wound dressing according to any one of claims 1 to 9, wherein the wound dressing has a water absorption capacity of 50 to 500% by weight.
を形成または準備し、該高含水ゲル形成性物質薄膜の少
なくとも一方の面に撥水性物質溶液を接触させ乾燥させ
た後、該高含水ゲル形成性物質薄膜を2価以上の金属イ
オンを含有する溶液に接触させ乾燥させ、そして、薄膜
状に形成された未硬化かつ粘着性を有する状態の水分透
過性薄膜形成性物質の上に、前記高含水ゲル形成性物質
薄膜の他方の面を載置し、その後該水分透過性薄膜形成
性物質を硬化させることを特徴とする創傷被覆材の製造
方法。(11) Forming or preparing a thin film of a highly hydrous gel-forming material that is biocompatible, contacting at least one surface of the thin film of the highly water-containing gel-forming material with a water-repellent material solution and drying it; A thin film of the gel-forming substance is brought into contact with a solution containing metal ions having a valence of two or more and dried, and then on the uncured and sticky water-permeable thin film-forming substance formed in the form of a thin film, A method for producing a wound dressing, comprising placing the other side of the thin film of the highly hydrous gel-forming material, and then curing the water-permeable thin film-forming material.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2037698A JPH03242145A (en) | 1990-02-19 | 1990-02-19 | Wound covering material and production thereof |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2037698A JPH03242145A (en) | 1990-02-19 | 1990-02-19 | Wound covering material and production thereof |
Publications (1)
Publication Number | Publication Date |
---|---|
JPH03242145A true JPH03242145A (en) | 1991-10-29 |
Family
ID=12504762
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2037698A Pending JPH03242145A (en) | 1990-02-19 | 1990-02-19 | Wound covering material and production thereof |
Country Status (1)
Country | Link |
---|---|
JP (1) | JPH03242145A (en) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0475807A2 (en) * | 1990-08-30 | 1992-03-18 | Terumo Kabushiki Kaisha | Wound-covering materials |
JP2007044174A (en) * | 2005-08-09 | 2007-02-22 | Alcare Co Ltd | Bandage |
JP2009529367A (en) * | 2006-03-10 | 2009-08-20 | ジュ−ヨン キム | Method for producing silver-bonded antibacterial wet wound dressing and wet wound dressing produced by the method |
JP2015526189A (en) * | 2012-08-24 | 2015-09-10 | ツェルテル ポルスカ エスペー・ゾオCelther Polska Sp. Z O.O. | Active polymer layer comprising chitin derivative especially for bandage and use thereof |
-
1990
- 1990-02-19 JP JP2037698A patent/JPH03242145A/en active Pending
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0475807A2 (en) * | 1990-08-30 | 1992-03-18 | Terumo Kabushiki Kaisha | Wound-covering materials |
JP2007044174A (en) * | 2005-08-09 | 2007-02-22 | Alcare Co Ltd | Bandage |
JP2009529367A (en) * | 2006-03-10 | 2009-08-20 | ジュ−ヨン キム | Method for producing silver-bonded antibacterial wet wound dressing and wet wound dressing produced by the method |
US8263116B2 (en) | 2006-03-10 | 2012-09-11 | Cellulose Concepts, Llc | Methods for producing silver-bonded antimicrobial moist wound dressings and moist wound dressings produced by the methods |
US8409608B2 (en) | 2006-03-10 | 2013-04-02 | Cellulose Concepts, Llc | Methods for producing silver-bonded antimicrobial moist wound dressings and moist wound dressings produced by the methods |
JP2015526189A (en) * | 2012-08-24 | 2015-09-10 | ツェルテル ポルスカ エスペー・ゾオCelther Polska Sp. Z O.O. | Active polymer layer comprising chitin derivative especially for bandage and use thereof |
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