590763 A7 B7 五、發明說明（1 ) 10 15 20 發明說明 本發明是關於創傷敷料，其併有一吸收結構，及一用 於在創傷表面_適當關程度的水凝膠層。 已知維持微濕的創傷環境有助於治療創傷，特別是燒 傷與慢性創傷，諸如潰瘍。錢，避免過多的水分或創傷 分泌物累積於創傷上亦係所欲者，原因為液體分泌物導致 鄰近於創傷的皮膚變軟及其他目難。此外，液體分泌物可 月色自創傷處漏出並污染衣服或寢具。 實際上，難以在創傷處維持所欲的濕潤程度，原因為 對於任何單-創傷而言，創傷流體的產生隨著創傷及時間 而改變。此可能導致必須經常改變敷料，及需要各種敷料 以治療不同的創傷。 本發明之一目的是提供結構，以充當或用於改進治療 各種創傷的多層敷料。 本發明提供-種創傷敷料，包括··一液體可透過的頂 片，其具有一面對創傷的表面及一背面，該頂片可阻礙或 限制液體自背面而流至面對創傷的表面；及一水凝膠層， 其在頂片之面對創傷的表面上。 較佳地，敷料又包括一在頂片之背面上方的支持層。 支持層支撐頂片及一中間吸收層（如果存在的話），且較佳 為提供微生物通過敷料的障礙物。支持層可延伸越過吸收 層的至少一邊緣，以提供一鄰近於該邊緣之塗有粘劑的界 限，用於將敷料粘合至一表面，諸如粘合至所治療之創傷 附近的病人皮膚。塗有粘劑的界限可延伸於吸收層之所有 閲 ▲ 本紙張尺度適用中國國家標準（CNS)A4規格（21G X 297公爱) 590763 A7 經 濟 部 智 慧 財 產 局 貝 工 消 费 合 作 社 印 製 五、發明說明（2 側部的周圍，以致於敷料是所謂島狀敷料。然而，不需要 有任何塗有粘劑的界限。 較佳地，支持層大致上是液體不可透過的。支持片較 佳為半透過式。即’支持片較佳為水蒸氣可以透過，但液 體水或創傷分泌物不可透過。較佳地，支持片也是微生物 不可透過的。適當連續可貼合的支持片之水蒸氣透過率 (MVTR)較佳為在37.5°C、100%至10%的相對濕度差時， 單獨的支持片是300至5000公克/平方公尺/24小時，較 佳是500至2000公克/平方公尺/24小時。支持片厚度較 佳為在10至1000微米的範圍，更佳為1〇〇至5〇〇微米。 依據本發明之敷料整體的MVTR低於單獨的支持 片’原因在於頂片部分阻礙水分之傳送通過敷料。較佳 地，敷料的MVTR(越過敷料的島狀部分而測量)是單獨的 支持片之MVTR的20%至80%，更佳為自20〇/〇至6〇0/〇， 最佳為約40%。已經發現，此水蒸氣透過率可以在濕潤 的狀況下治療敷料下方的創傷，而不會使環繞創傷的皮廣 變軟。 用於形成支持片之適當的聚合物包含聚胺基甲酸醋與 聚烧氧基燒基丙締酸醋及甲基丙稀酸g旨，諸如英國專利 GB-A-1280631號所揭示者。較佳地，支持片包括一高密 度充填的聚胺酯泡沫連績層，其主要是封閉單元。適當的 支持片材料是聚胺酯薄膜，其可得自於註冊商標係 ESTANE 5714F 的薄膜。 粘合層（如果存在的話)必須是水蒸氣可透過及/或圖案 10 15 20 -4- 本紙張尺度適用中國國豕標準（CNS)A4規格（210 X 297公爱 (請先閲讀背面之注意事項再填窝本頁) 裝 訂： 線· 91. 1. 3,000 590763590763 A7 B7 V. Description of the invention (1) 10 15 20 Description of the invention The present invention relates to a wound dressing, which has an absorbent structure, and a hydrogel layer which is suitable for the wound surface. It is known that maintaining a slightly moist wound environment helps to treat wounds, especially burns and chronic wounds, such as ulcers. Money, to avoid excessive moisture or wounds accumulation on the wound is also desirable, because the liquid secretion causes the skin adjacent to the wound to soften and other difficulties. In addition, liquid discharge can leak from the wound and contaminate clothing or bedding. In fact, it is difficult to maintain the desired degree of moisturization at the trauma because, for any single-trauma, the production of trauma fluid changes with trauma and time. This may result in the necessity to change the dressing frequently, and the need for various dressings to treat different wounds. It is an object of the present invention to provide a structure to act as or be used as a multi-layer dressing to improve the treatment of various wounds. The present invention provides a wound dressing comprising: a liquid-permeable top sheet having a surface facing the wound and a back surface, the top sheet preventing or restricting the flow of liquid from the back surface to the surface facing the wound; And a hydrogel layer on the wound-facing surface of the topsheet. Preferably, the dressing further comprises a support layer above the back surface of the topsheet. The support layer supports the topsheet and an intermediate absorbent layer, if present, and preferably provides an obstacle for microorganisms to pass through the dressing. The support layer may extend across at least one edge of the absorbent layer to provide an adhesive-coated boundary adjacent to the edge for bonding the dressing to a surface, such as to the patient's skin near the wound being treated. The limit of coating with adhesive can be extended to all readings of the absorbent layer. ▲ This paper size applies to China National Standard (CNS) A4 (21G X 297 public love) 590763 A7 Printed by the Shellfish Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. Explanation (2 The periphery of the sides, so that the dressing is a so-called island dressing. However, there is no need to have any adhesive-coated boundaries. Preferably, the support layer is substantially liquid-impermeable. The support sheet is preferably half Permeable type. That is, 'the support sheet is preferably water vapor permeable, but liquid water or wound secretion is impermeable. Preferably, the support sheet is also impermeable to microorganisms. The water vapor transmission rate of a suitable continuous and conformable support sheet (MVTR) is preferably at a relative humidity difference of 100% to 10% at 37.5 ° C, and the separate support sheet is 300 to 5000 g / m 2/24 hours, preferably 500 to 2000 g / m 2 / 24 hours. The thickness of the support sheet is preferably in the range of 10 to 1000 microns, more preferably 100 to 500 microns. The overall MVTR of the dressing according to the present invention is lower than that of the support sheet alone because the top sheet portion is Hinder Moisture is transmitted through the dressing. Preferably, the MVTR (measured across the island portion of the dressing) of the dressing is 20% to 80% of the MVTR of the individual support sheet, more preferably from 20/0 to 60 / 〇, the best is about 40%. It has been found that this water vapor transmission rate can treat wounds under the dressing under moist conditions without softening the skin surrounding the wounds. Appropriate polymerization for forming a support sheet The material includes polyurethane, polyoxyalkylene, and acrylic acid, such as those disclosed in British Patent GB-A-1280631. Preferably, the support sheet includes a high density Filled polyurethane foam succession layer, which is primarily closed cells. A suitable support sheet material is a polyurethane film, which is available from films under the registered trademark ESTANE 5714F. The adhesive layer (if present) must be water vapor permeable And / or pattern 10 15 20 -4- This paper size is applicable to China National Standard (CNS) A4 (210 X 297 public love (please read the precautions on the back before filling this page) Binding: Thread · 91. 1 . 3,000 590763
化以允許水蒸氣通過彼0枯合層較佳為連續水蒸氣可透 過、壓力敏感枯合層，其型式是傳統上使用於島狀創傷敷 料者，例如，基於丙烯酸酯共聚物、聚乙烯乙基醚與聚胺 基甲酸S曰的壓力敏感粘劑，如英國專利gb_a_128〇63i號 5所述者。粘合層的基準重量(basis weight)較佳為2〇至 250公克/平方公尺，更佳為5〇至15〇公克/平方公尺。基 於聚胺基甲酸酯的壓力敏感粘劑係較佳。 較佳地，粘合層自吸收層與封包向外延伸，以在粘合 層周圍的支持片上形成一塗有粘劑的界限，如同在傳統島 10 狀敷料中者。 選擇性吸收層的面積典型上在自i平方公分至2⑻平 方公分的範圍，更佳為自4平方公分至100平方公分的範 圍。 經濟部智慧財產局貝工消费合作社印製 選擇性吸收層可以是在創傷治療技藝中傳統上用於吸 15 收創傷流體、血清或血液的任何層，包含紗布、不織布、 超吸收物、水凝膠及其混合物。較佳地，吸收層包括一吸 收泡沫層，諸如根據歐洲專利EP-A-0541391號製備的開 放單元式親水性聚胺基甲酸酯泡沫，其全部内容以引用的 方式併入本文中。在其他實施例中，吸收層可以是不織的 20 纖維網，例如，粘膠短織維之粗梳纖維網。吸收層的基準 重量可以是在50-500公克/平方公尺的範圍，諸如loo-400公克/平方公尺。吸收層之未壓縮的厚度可以是在自 〇·5公厘至10公厘的範圍，諸如1公厘至4公厘。用於 生理食鹽水之測得的自由（未壓縮）液體吸收率於250C時可 91. 1. 3,000 本紙張尺度適用中國國家標準（CNS)A4規格（21〇 X 297公釐） 590763 A7 m ----------B7 ---------— 五、發明說明（4 ) 以在5至30公克/公克的範圍。 {請先閱讀背面之注意事項再填寫本頁} 選擇性吸收層可以額外包括一或更多活性治療或抗微 生物劑。適當的治療劑包含成長因子、止痛劑、局部麻醉 劑與類固醇。適當的抗微生物劑包含諸如銀化合物(例 5如’續胺嘴咬銀)與氣海希啶(chlorhexidine)的抗菌劑與抗 生素。治療或抗微生物劑通常是以基於吸收層乾燥重量的 自0.01%至5%重量之數量而添加。在吸收層中提供抗微 生物劑較佳為基於二理由（1)簡單的製造路徑，及(2)使抗 微生物劑離開創傷可以在不需要時_例如，較乾燥的創傷_ 10防止非必要地暴露於抗微生物劑。於存在更高的分泌物 時，當吸收層變濕時，將釋放更高位準的抗微生物劑。當 方向性頂片必須限制分泌物回流至創傷（藉由液體的表面 張力而有若干程度）時，抗微生物劑必須抗拒濃度梯度而 返回通過穿孔片並進入創傷。已知道，諸如銀離子的抗微 15 生物劑成分可以通過相對低位準的水分而輸送。 經濟部智慧財產局貝工消费合作社印製 依據本發明之創傷敷料的頂片是液體可透過的，但可 作用以阻礙或限制液體自背面流到創傷處。即，頂片允許 流體自創傷處通過頂片，但阻礙或限制流體通過頂片而回 流於創傷上（亦稱為逆濕潤）。此不濕潤的頂片可-例如-由 20 多孔性不織布製成，其包括一疏水性纖維層，或具有一施 加於至少其外表面的疏水性拋光(hydrophobic finish)。較 佳地，頂片對於離開面對創傷的表面之液體流的液體可透 過度大於朝向面對創傷的表面之液體流。 較佳地，頂片由大致上係液體不可透過的薄片材料形 -6_ 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐〉 91 3,000 590763 A7 五、發明說明（5 ) 成，其具有推拔式毛細管，每一毛細管具有一基部及一頂 開口，基部大致上在頂片之面對創傷的表面之平面中，頂 開口則遠離頂片之面對創傷的表面且較佳為接觸於一吸收 層。圓錐狀毛細管提供來自頂片前方之流體的快速單向毛 5細作用，而逆濕潤最少。此型式的頂片描述於英國專利 GB-A-1526778 號。 頂片薄膜可以由熱塑性薄膜形成聚合物所形成。較佳 地，聚合物是可貼合的，但大致上係非彈性。適當的聚合 物包含(但不限於）聚乙烯、聚丙烯、聚酯、諸如尼龍的聚 醯胺、諸如聚偏二氟乙稀(PVDF)或聚四氟乙烯(ptfe)的 氟聚合物，以及其混合物。頂片較佳為聚烯烴薄膜。較佳 地，薄膜的厚度按重量(by weight)(ASTME252-84)是自 10至200微米，更佳為自25至1〇〇微米。 較佳地，毛細管大致上是截頭圓錐的形式。較佳地， 毛細管的基部開口尺寸(在頂片之平面申的最大開口尺寸） 是自0.1公厘至3公厘，頂開口尺寸（遠離頂片之平面）是 自0·05至2公厘。更佳地，毛細管的基部開口尺寸在此 界定為自0·3公厘至1公厘，頂開口尺寸為自〇1公厘至 0.5公厘。 較佳地’毛細管的平均推拔角（自垂直於頂片平面處 測量）是自10至60度。較佳地，頂片的壓花厚度（依 ASTMD374-79)是自0.2公厘至2公厘，更佳地，自0.4 公厘至1公厘。 此型式的頂片可以藉由_例如-將液體不可透過的熱塑 10 15 20 •7- 本紙張尺度適用中國國家標準（CNS)A4規格（210χ297^[ 91. 1. 3,000 <請先閱讀背面之注意事項再填寫本頁) •裝 線- 590763It is suitable to allow water vapor to pass through the dry layer, preferably a continuous water vapor permeable, pressure-sensitive dry layer. Its type is traditionally used for island wound dressings, for example, based on acrylic copolymers, polyethylene glycol Pressure sensitive adhesives based on ethers and polyurethanes, such as those described in British Patent gb_a_128〇63i No. 5. The basis weight of the adhesive layer is preferably 20 to 250 g / m 2, and more preferably 50 to 150 g / m 2. Polyurethane based pressure sensitive adhesives are preferred. Preferably, the adhesive layer extends outwardly from the absorbent layer and the packet to form an adhesive-coated boundary on the support sheet around the adhesive layer, as in conventional island-like dressings. The area of the selective absorption layer typically ranges from i cm 2 to 2 cm 2, and more preferably ranges from 4 cm 2 to 100 cm 2. The selective absorption layer printed by the Shelley Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs can be any layer traditionally used to absorb 15 wound fluids, serum or blood in wound healing techniques, including gauze, non-woven fabric, superabsorbent, hydrocoagulation Gum and its mixtures. Preferably, the absorbent layer comprises an absorbent foam layer, such as an open-cell hydrophilic polyurethane foam prepared according to European Patent EP-A-0541391, the entire contents of which are incorporated herein by reference. In other embodiments, the absorbent layer may be a non-woven 20 web, such as a carded web of viscose staple weave. The base weight of the absorbent layer may be in the range of 50-500 g / m2, such as loo-400 g / m2. The uncompressed thickness of the absorbent layer may be in a range from 0.5 mm to 10 mm, such as 1 mm to 4 mm. Used for measuring the free (uncompressed) liquid absorption of physiological saline at 250C. 91. 1. 3,000 This paper size is applicable to China National Standard (CNS) A4 (21〇X 297 mm) 590763 A7 m- --------- B7 ---------— V. Description of the invention (4) The range is from 5 to 30 g / g. {Please read the notes on the back before filling out this page} The selective absorption layer can additionally include one or more active therapeutic or anti-biological agents. Suitable therapeutic agents include growth factors, analgesics, local anesthetics and steroids. Suitable antimicrobial agents include antibacterial agents and antibiotics such as silver compounds (e.g., 5 ' amine mouth bites silver) and chlorhexidine. The therapeutic or antimicrobial agent is usually added in an amount of from 0.01% to 5% by weight based on the dry weight of the absorbent layer. The provision of an antimicrobial agent in the absorbent layer is preferably based on two reasons: (1) a simple manufacturing path, and (2) removing the antimicrobial agent from the wound can be unnecessary when it is not needed, for example, a dry wound, 10 Exposure to antimicrobial agents. In the presence of higher secretions, higher levels of antimicrobial agents will be released when the absorbent layer becomes wet. When the directional topsheet must limit the return of secretions to the wound (to some extent by the surface tension of the liquid), the antimicrobial agent must resist the concentration gradient and return through the perforated sheet and into the wound. It is known that anti-micro 15 biological agent components such as silver ions can be delivered by relatively low levels of moisture. Printed by Shelley Consumer Cooperative, Bureau of Intellectual Property, Ministry of Economic Affairs, The top sheet of the wound dressing according to the present invention is liquid permeable, but can act to block or restrict the flow of liquid from the back to the wound. That is, the topsheet allows fluid to pass from the wound to the topsheet, but prevents or restricts fluid from flowing back through the topsheet to the wound (also known as reverse wetting). This non-wet topsheet may be-for example-made of a 20-porous nonwoven fabric, which includes a layer of hydrophobic fibers, or has a hydrophobic finish applied to at least its outer surface. Preferably, the topsheet is more permeable to liquid flowing away from the wound-facing surface than liquid flowing toward the wound-facing surface. Preferably, the top sheet is formed of a substantially liquid-impermeable sheet material. The size of this paper is applicable to China National Standard (CNS) A4 (210 X 297 mm> 91 3,000 590763 A7. V. Description of the invention (5) It has a push-type capillary, each capillary has a base and a top opening, the base is generally in the plane of the top sheet facing the wound surface, and the top opening is away from the top sheet facing the wound surface and is preferred To contact an absorbent layer. The conical capillaries provide a fast unidirectional capillary action of the fluid from the front of the topsheet with minimal back wetting. This type of topsheet is described in British Patent GB-A-1526778. Topsheet film Can be formed from a thermoplastic film forming a polymer. Preferably, the polymer is conformable, but is generally non-elastic. Suitable polymers include, but are not limited to, polyethylene, polypropylene, polyester, such as nylon Polyamine, fluoropolymers such as polyvinylidene fluoride (PVDF) or polytetrafluoroethylene (ptfe), and mixtures thereof. The topsheet is preferably a polyolefin film. Preferably, the thickness of the film is by weight (by weight) ( ASTME252-84) is from 10 to 200 microns, and more preferably from 25 to 100 microns. Preferably, the capillary is in the form of a frustoconical shape. Preferably, the base opening size of the capillary (in the top sheet) The maximum opening size of the plane application) is from 0.1 mm to 3 mm, and the top opening size (the plane away from the top sheet) is from 0.05 to 2 mm. More preferably, the base opening size of the capillary is defined here as From 0.3 mm to 1 mm, the size of the top opening is from 0.01 mm to 0.5 mm. Preferably the average push-out angle of the capillary (measured from perpendicular to the plane of the top sheet) is from 10 to 60 Preferably, the embossing thickness (according to ASTM D374-79) of the top sheet is from 0.2 mm to 2 mm, and more preferably, from 0.4 mm to 1 mm. This type of top sheet can be obtained by _ For example-the liquid-impermeable thermoplastic 10 15 20 • 7- This paper size applies the Chinese National Standard (CNS) A4 specification (210χ297 ^ [91. 1. 3,000 < Please read the precautions on the back before filling this page) • Installation line-590763
經濟部暫慧財產局貝工消费合作社印製 性薄膜壓花或真空穿孔而製造。較佳地，毛細管的密度是 自每10至400平方公分，更佳為自每50至200平方公 分。較佳地，頂片的開口面積是總面積的自5至5〇%， 更佳為總面積的自10至25%。 5 現在已經發現，令人驚異的是施加一水凝膠層蓋此頂 片的頂表面使得在廣大範圍的創傷滲出率，微濕的創傷環 境能夠維持更長的時期。頂片連續吸走創傷流體以防止 創傷中有過多的水分，但此並不導致水凝膠的移除或頂片 被水凝膠阻礙^當創傷分泌物的產生率下降時，水凝膠自 10吸收層吸收水蒸氣，且保持濕潤的創傷接觸表面。水凝膠 不會導致通過頂片的逆濕潤實質上增加。 較佳地，水凝膠層的乾燥基準重量是自10至200公 克/平方公尺，更佳為自10至100公克/平方公尺，最佳 為自10至50公克/平方公尺。 15 術語「水凝膠層」大體上意指層-其在生理狀況下與 創傷表面互相作用’以在創傷表面維持升高的濕潤程度。 較佳地，水凝膠層在溫度與pH的生理狀況下與水形成凝 膠。此水凝膠層可以藉由包含醫療上可接受的巨分子材 料-其較佳為具有膨脹及吸收流體的能力，並維持堅固的 20 一體式結構-而形成。水凝膠材料在生理狀況下大致上不 溶於水，而水凝膠不會被創傷流體沖走。水凝膠可以是生 物聚合物，及/或它可以是生物可吸收的。即，它在活的 有機體内可漸漸被再吸收。 示範性不可溶的凝膠包含特定交又鏈接的聚丙烯酸鹽 (請先Μ讀背面之注意事項再填寫本頁) 裝 訂： -線· 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） 91. 1. 3,000 590763 A7 五、發明說明（7 凝膠、海藻酸鈣凝膠、交又鏈接的透明質酸鹽凝膠，其令 水凝膠層包括水凝膠材料，其選自於由乙烯基醇、乙烯基 酯、乙烯基醚與羧乙烯基單體、甲基（丙烯）酸、丙烯醯 胺〜义乙烯基吡咯酮’醯胺基丙烷⑽^碰也㈣卵加）、 5磺酸、PLURONIC(註冊商標)(塊狀聚乙二醇、塊狀聚丙二 醇）聚苯乙烯、馬來酸、NN-二甲基丙烯醯胺、二丙酮丙 烯醯胺、丙烯醢嗎福啉及其混合物所形成的凝膠。較佳 地，凝膠堅固粘結至頂片材料的表面，以抗拒創傷流體的 沖洗。在特定實施例中，凝膠可以化學粘合至頂片的表 10 面。 較佳地，水凝膠層包括水凝膠材料，其選自於由聚胺 基甲酸酯凝膠、雙聚合物凝膠、致甲基纖維素凝膠、羥乙 基纖維素凝膠、經丙基曱基纖維素、改質的丙稀酿胺及其 混合物。適當的雙聚合物凝膠包含海藻酸、果膠、半乳糖 15配甘露聚糖、殼聚糖、明膠、透明質酸鹽及其混合物。這 些雙聚合物材料中有某些也可幫助治療創傷。 較佳地，凝膠是交又鏈接，且交又鏈接可以是共價或 離子式。 較佳地，水凝膠材料又包括一或更多諸如甘油的濕潤 20 劑之乾燥基準重量的5至50%重量。 較佳地，水凝膠層包括WO00/07638號所述型式的水 凝膠材料，其全部内容以引用的方式併入本文中。 替代地或額外地，關於形成凝膠的巨分子，水凝膠層 可包括一或更多軟化劑。軟化劑是用於使皮虜的表面平 -9· 本紙張尺度適用中國國家標準(CNS)A4規格（21〇 X 297公爱〉 (請先閲讀背面之注意事項再填寫本頁) •裝 訂： 經 部 智 慧 財 產 局 貝 工 消 费 合 作 社 印 製 91. 1. 3,000 590763 A7Manufactured by printed film embossing or vacuum perforation at the Beihui Consumer Cooperative of the temporary Hui Property Bureau of the Ministry of Economic Affairs. Preferably, the density of the capillary is from every 10 to 400 square centimeters, more preferably from every 50 to 200 square centimeters. Preferably, the opening area of the top sheet is from 5 to 50% of the total area, more preferably from 10 to 25% of the total area. 5 It has now been found that it is amazing to apply a hydrogel layer to cover the top surface of this topsheet so that a slightly wet wound environment can be maintained for a longer period of time over a wide range of wound exudation rates. The top sheet continuously sucks the wound fluid to prevent excessive moisture in the wound, but this does not cause the removal of the hydrogel or the top sheet is blocked by the hydrogel. ^ When the rate of wound secretion declines, the hydrogel automatically The 10 absorbent layer absorbs water vapor and keeps the wet wound contact surface. The hydrogel does not cause a substantial increase in back wetting through the topsheet. Preferably, the dry basis weight of the hydrogel layer is from 10 to 200 g / m 2, more preferably from 10 to 100 g / m 2, and most preferably from 10 to 50 g / m 2. 15 The term "hydrogel layer" generally means a layer-which interacts with the wound surface under physiological conditions' to maintain an increased degree of wetting on the wound surface. Preferably, the hydrogel layer forms a gel with water under physiological conditions of temperature and pH. This hydrogel layer can be formed by containing a medically acceptable macromolecular material, which preferably has the ability to swell and absorb fluids, and maintains a strong 20-piece monolithic structure. The hydrogel material is substantially insoluble in water under physiological conditions, and the hydrogel is not washed away by the wound fluid. The hydrogel may be a biopolymer, and / or it may be bioabsorbable. That is, it is gradually reabsorbed in living organisms. Exemplary insoluble gel contains specific cross-linked polyacrylates (please read the precautions on the back before filling out this page) Binding: -line · This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) 91. 1. 3,000 590763 A7 V. Description of the invention (7 gel, calcium alginate gel, cross-linked hyaluronate gel, the hydrogel layer includes a hydrogel material, and It is selected from the group consisting of vinyl alcohol, vinyl ester, vinyl ether and carboxyvinyl monomer, meth (acrylic) acid, acrylamide ~ s-vinylpyrrolidone ', amino propane, ^ bump also ㈣ eggs plus ), 5 sulfonic acid, PLURONIC (registered trademark) (block polyethylene glycol, block polypropylene glycol) polystyrene, maleic acid, NN-dimethyl acrylamide, diacetone acrylamide, acrylamide A gel formed by phenanthroline and its mixture. Preferably, the gel is firmly adhered to the surface of the topsheet material to resist flushing of the wound fluid. In a particular embodiment, the gel can be chemically bonded to the top surface of the topsheet. Preferably, the hydrogel layer comprises a hydrogel material selected from the group consisting of a polyurethane gel, a dual polymer gel, a methylocellulose gel, a hydroxyethylcellulose gel, Modified by propyl phosphonium cellulose, modified acrylic amine and mixtures thereof. Suitable dual polymer gels include alginic acid, pectin, galactose 15 with mannan, chitosan, gelatin, hyaluronate and mixtures thereof. Some of these bipolymer materials can also help treat wounds. Preferably, the gel is crosslinked, and the crosslinked may be covalent or ionic. Preferably, the hydrogel material further comprises 5 to 50% by weight of the dry basis weight of one or more moisturizing agents such as glycerol. Preferably, the hydrogel layer comprises a hydrogel material of the type described in WO 00/07638, the entire contents of which are incorporated herein by reference. Alternatively or additionally, with regard to the gel-forming macromolecules, the hydrogel layer may include one or more softeners. The softener is used to flatten the surface of Pirup-9. This paper size is applicable to China National Standard (CNS) A4 (21〇X 297 public love) (Please read the precautions on the back before filling this page) • Binding: Printed by Shelley Consumer Cooperatives, Ministry of Economic Affairs, Intellectual Property Bureau 91. 1. 3,000 590763 A7
貝 製 7月，^項加水合的程度。它們是藉由阻擋水自皮膚外層流 失或藉由改進水與皮膚的結合而作用。軟化劑在治療遺傳 過敏性濕療與魚鱗癖時特別有用。較佳的軟化劑包含白軟 石蠟、頁軟石蠟、液體石蠟、尿素乳膏、羊毛脂、吡咯_ 5叛化鈉(PCANa)、夜見草萃取物(加瑪亞麻油酸）、大豆 油、茶樹油、椰子油、杏仁油、甘菊萃取物、魚肝油、花 生油、食火雞油、鮮、向日葵油、鱷梨油、荷荷巴油、 可可醯胺（cocoamide)及其混合物。 水凝膠層可額外包括一或更多活性治療或抗微生物 1〇劑。適當的治療劑包含成長因子、止痛劑、局部麻醉劑與 類固醇。適當的抗微生物劑包含諸如銀化合物（例如，磺 胺嘧啶銀)與氯海希啶(chlorhexidine)的抗菌劑及抗生素。 治療或抗微生物劑通常是以基於吸收層之乾燥重量的自 〇·〇1%至5%重量之數量而添加。 水凝膠層可以是連續或不連續，但無論如何較佳為對 準頂片中的毛細管而穿孔，以免阻礙流體進人毛細管，即 使當水凝膠完全膨脹時亦然。另言之，較佳為起初大致上 無水凝膠存在或遮蓋頂片的毛細管。水凝膠層可以藉由喷 灑或較佳地藉由印刷或轉印過程施加。 較佳地，依據本發明的多層創傷敷料又包括一或更多 保護遮蓋片，其在水凝膠層與任何暴露的粘劑上方。例 如，此可能包括一或更多釋放塗佈的紙遮蓋片。較佳地， 敷料是消過毒的，且包裝於微生物不可透過的容器中。 本發明又提供使用-依據本發明的多層創傷敷料，用 -10- 本紙張尺度適用中_家標準（CNS)A4規格⑽x 297公髮- 15 20 (請先閱讀背面之注意事項再填寫本頁}Degree of hydration in July. They work by blocking the loss of water from the outer layers of the skin or by improving the binding of water to the skin. Emollients are particularly useful in the treatment of hereditary allergic moisture therapy and ichthyosis. Preferred softeners include white soft paraffin, page soft paraffin, liquid paraffin, urea cream, lanolin, pyrrolidine-5 (PCANa), evening primrose extract (garma linoleic acid), soybean oil, Tea tree oil, coconut oil, almond oil, chamomile extract, cod liver oil, peanut oil, turkey oil, fresh, sunflower oil, avocado oil, jojoba oil, cocoamide and mixtures thereof. The hydrogel layer may additionally include one or more active therapeutic or antimicrobial agents. Suitable therapeutic agents include growth factors, analgesics, local anesthetics and steroids. Suitable antimicrobial agents include antibacterial agents and antibiotics such as silver compounds (eg, silver sulfadiazine) and chlorhexidine. The therapeutic or antimicrobial agent is usually added in an amount of from 0.01% to 5% by weight based on the dry weight of the absorbent layer. The hydrogel layer may be continuous or discontinuous, but in any case, it is preferred to perforate the capillaries in the topsheet so as to prevent the entry of fluid into the capillaries, even when the hydrogel is fully expanded. In other words, it is preferred that capillaries of the topsheet are substantially absent from the beginning or cover the topsheet. The hydrogel layer can be applied by spraying or preferably by a printing or transfer process. Preferably, the multilayer wound dressing according to the present invention further comprises one or more protective covering sheets, which are above the hydrogel layer and any exposed adhesive. For example, this may include one or more release coated paper cover sheets. Preferably, the dressing is sterile and packaged in a container that is impermeable to microorganisms. The present invention also provides the use-a multi-layer wound dressing according to the present invention, with -10- this paper size is applicable _ home standard (CNS) A4 size ⑽ 297 public-15 20 (Please read the precautions on the back before filling this page }
590763 A7 經濟部智慧財產局貝工消费合作社印製 五、發明說明（9 ) 於製備敷料，以施加至創傷。 在又一特點中，本發明提供一種治療創傷之方法，其 包括的步驟是施加依據本發明的敷料至創傷的表面，而水 凝膠與創傷接觸。 5 現在將舉例並參考附圖，進一步說明本發明之一實施 例，附圖中： 圖1顯示一依據本發明之創傷敷料的下(接觸創傷)表 面之透視圖；而 圖2顯示通過圖1之敷料的島狀區域之部分橫剖面 10 (未照比例）。 參考圖1，創傷敷料是島形自粘式創傷敷料，包括一 微孔性液體不可透過的聚胺基甲酸酯泡沫之支持層1，諸 如ESTANE 5714F(註冊商標）。支持層可以讓水蒸氣透 過，但不讓創傷分泌物與微生物透過。 支持層1塗有壓力敏感聚胺基曱酸酯枯劑的大致上連 績層2。 吸收層3是如歐洲專利EP-A_0541391號所述而製備 的親水性聚胺基甲酸酯泡沫層，且具有約350公克/平方 公尺的基準重量及約1.5公厘的厚度。 頂片4延伸於吸收層3上方，且部分包覆於吸收層3 周圍，頂片的邊緣5藉由粘劑2粘合至吸收層3下方的支 持層1。此在圖2中可以看得更清楚。頂片是聚胺基甲酸 醋薄膜，其已穿孔，每平方公分約90孔，每一孔大致上 是圓錐形，如上述，最大的孔直徑是約〇·5公厘，開口面 -11· 表紙張尺度適用中規格⑽χ挪公爱） 15 20 91. 1. 3,000 (請先閱讀背面之注意事項再填寫本頁) 裝 --線· 590763 A7 _-___B7 五、發明說明（⑺） 積是前面之總面積的16%，厚度以重量計是約43微米， 壓花厚度是約0.5公厘。此頂片可得自於維吉尼亞州 Richmond的Tredegar薄膜產品公司以註冊商標vISp〇RE 銷售者。 5 參考圖2，頂片4提供一平滑、穿孔的頂表面給創 傷。此表面塗有一藉由喷灑施加的水凝膠6層，其對準頂 片中的毛細管而穿孔，以允許流體進入毛細管，即使當水 凝膠完全膨脹時亦然。水凝膠6的乾燥基準重量是3〇公 克/平方公尺，且由與戊二醛或甲醛交叉鏈接的牛凝膠組 10 成。 圖1所示敷料之面對創傷的表面由塗有矽氧烷的二釋 放紙8、9保護，其包裝於微生物不可透過的囊袋中，且 使用加瑪射線消毒。 使用時，自包裝移除敷料，移除釋放紙，且敷料粘合 15至創傷周圍的皮膚，而頂片與水凝膠接觸於創傷，以提供 無毒及吸收性的敷料。水凝膠與頂片以迄今為止未預期的 方式互相作用，以就廣大範圍的創傷，提供微濕而未濕潤 的創傷環境達更長的時期。 已僅藉由例子說明以上實施例。落在附屬申請專利範 20圍的範疇中之很多其他實施例是專業的讀者顯而易知的。 --------------裝--- (請先閲讀背面之注意事項再填寫本頁) 會· •線· 經濟部智慧財產局貝工消费合作社印製 •12,590763 A7 Printed by Shelley Consumer Cooperatives, Bureau of Intellectual Property, Ministry of Economic Affairs 5. Description of Invention (9) In preparing dressings to apply to wounds. In yet another feature, the present invention provides a method for treating a wound, comprising the step of applying a dressing according to the present invention to the surface of a wound while the hydrogel is in contact with the wound. 5 An embodiment of the present invention will now be further described by way of example and with reference to the accompanying drawings, in which: FIG. 1 shows a perspective view of the lower (contact wound) surface of a wound dressing according to the present invention; Partial cross section 10 of the island-like area of the dressing (not to scale). Referring to FIG. 1, the wound dressing is an island-shaped self-adhesive wound dressing and includes a microporous liquid-impermeable polyurethane foam support layer 1, such as ESTANE 5714F (registered trademark). The support layer allows water vapor to pass through, but does not allow wound secretions and microorganisms to pass through. The support layer 1 is a substantially continuous layer 2 coated with a pressure-sensitive polyurethane urethane dehumidifier. The absorbent layer 3 is a hydrophilic polyurethane foam layer prepared as described in European Patent EP-A_0541391, and has a basis weight of about 350 g / m 2 and a thickness of about 1.5 mm. The top sheet 4 extends above the absorbent layer 3 and partially covers the periphery of the absorbent layer 3. The edge 5 of the top sheet is bonded to the support layer 1 under the absorbent layer 3 by an adhesive 2. This can be seen more clearly in FIG. 2. The top sheet is a polyurethane film, which has been perforated, with about 90 holes per square centimeter, and each hole is roughly conical. As mentioned above, the largest hole diameter is about 0.5 mm, and the open side is -11 · The paper size of the table is applicable to the specifications (⑽χ 挪 公公 爱) 15 20 91. 1. 3,000 (Please read the precautions on the back before filling out this page) Packing-line · 590763 A7 _-___ B7 V. Description of the invention (⑺) Product is The total area of the front is 16%, the thickness is about 43 microns by weight, and the embossed thickness is about 0.5 mm. This topsheet is available from Tredegar Film Products, Inc. of Richmond, Virginia under the registered trademark vISPORE RE seller. 5 Referring to Figure 2, the topsheet 4 provides a smooth, perforated top surface for wounding. This surface is coated with 6 layers of hydrogel applied by spraying, which is perforated against the capillaries in the topsheet to allow fluid to enter the capillaries, even when the hydrogel is fully expanded. The dry basis weight of the hydrogel 6 is 30 g / m 2 and is composed of a bovine gel group 10 crosslinked with glutaraldehyde or formaldehyde. The wound-facing surface of the dressing shown in Figure 1 is protected by siloxane-coated di-release papers 8 and 9, which are packaged in microbial-impermeable pouches and sterilized with gamma rays. When in use, the dressing is removed from the package, the release paper is removed, and the dressing adheres to the skin around the wound, and the top sheet contacts the wound with the hydrogel to provide a non-toxic and absorbent dressing. The hydrogel interacts with the top sheet in a way not previously expected to provide a slightly moist, but not moist, wound environment for a longer period of time for a wide range of wounds. The above embodiments have been described by way of example only. Many other embodiments that fall within the scope of the scope of the attached patent application are obvious to a professional reader. -------------- Equipment --- (Please read the precautions on the back before filling out this page) Conference • • Line • Printed by Shelley Consumer Cooperative, Intellectual Property Bureau, Ministry of Economic Affairs • 12,
590763 A7 _____ B7 五、發明說明（11) 圖式之元件代號說明 代號 名稱 1 支持層 2 連續層 3 吸收層 4 頂片 5 邊緣 6 水凝膠 8 釋放紙 9 釋放紙 (請先閲讀背面之注意事項再填寫本頁) -裝 --線· 經濟部智慧財產局貝工消费合作社印製 -13- 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公* ) 91. 1. 3,000590763 A7 _____ B7 V. Description of the invention (11) Description of the component code of the drawing Code name 1 Supporting layer 2 Continuous layer 3 Absorptive layer 4 Top sheet 5 Edge 6 Hydrogel 8 Release paper 9 Release paper (Please read the note on the back first Please fill in this page for further information) -Installation-line · Printed by Shelley Consumer Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs-13- This paper size is applicable to China National Standard (CNS) A4 (210 X 297 male *) 91. 1. 3,000