TW589337B - The self-supporting apertured sheets, the method of manufacture of the same and the wound dressings comprising the same - Google Patents

The self-supporting apertured sheets, the method of manufacture of the same and the wound dressings comprising the same Download PDF

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TW589337B
TW589337B TW091116522A TW91116522A TW589337B TW 589337 B TW589337 B TW 589337B TW 091116522 A TW091116522 A TW 091116522A TW 91116522 A TW91116522 A TW 91116522A TW 589337 B TW589337 B TW 589337B
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Taiwan
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patent application
scope
item
hydrogel
plate
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TW091116522A
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Chinese (zh)
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Breda Mary Cullen
Andrew James Kirkwood
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Johnson & Johnson Medical Ltd
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B3/00Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form
    • B32B3/26Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by a particular shape of the outline of the cross-section of a continuous layer; characterised by a layer with cavities or internal voids ; characterised by an apertured layer
    • B32B3/266Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by a particular shape of the outline of the cross-section of a continuous layer; characterised by a layer with cavities or internal voids ; characterised by an apertured layer characterised by an apertured layer, the apertures going through the whole thickness of the layer, e.g. expanded metal, perforated layer, slit layer regular cells B32B3/12
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/01Non-adhesive bandages or dressings
    • A61F13/01034Non-adhesive bandages or dressings characterised by a property
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings
    • A61F13/0203Adhesive bandages or dressings with fluid retention members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/425Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/60Liquid-swellable gel-forming materials, e.g. super-absorbents
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/18Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by features of a layer of foamed material
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04Interconnection of layers
    • B32B7/12Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00089Wound bandages
    • A61F2013/00217Wound bandages not adhering to the wound
    • A61F2013/00229Wound bandages not adhering to the wound with alginate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00089Wound bandages
    • A61F2013/00246Wound bandages in a special way pervious to air or vapours
    • A61F2013/00251Wound bandages in a special way pervious to air or vapours with macroscopic openings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/00519Plasters use for treating burn
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00727Plasters means for wound humidity control
    • A61F2013/00731Plasters means for wound humidity control with absorbing pads
    • A61F2013/0074Plasters means for wound humidity control with absorbing pads containing foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00727Plasters means for wound humidity control
    • A61F2013/00748Plasters means for wound humidity control with hydrocolloids or superabsorbers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00855Plasters pervious to air or vapours
    • A61F2013/00859Plasters pervious to air or vapours with macroscopic openings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00897Plasters package for individual plaster
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00Properties of the layers or laminate
    • B32B2307/70Other properties
    • B32B2307/726Permeability to liquids, absorption
    • B32B2307/7265Non-permeable
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2535/00Medical equipment, e.g. bandage, prostheses or catheter

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Epidemiology (AREA)
  • Materials Engineering (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

A self-supporting apertured sheet consisting essentially of a water-swellable hydrogel composition, wherein the area of the apertures is up to about 50% of the area of the sheet before swelling. Also provided are wound dressings comprising such sheets. Also provided is a method of making such sheets comprising the steps of: providing an apertured substrate sheet; coating an aqueous hydrogel precursor onto the apertured substrate; curing the aqueous hydrogel precursor on the substrate to form an apertured hydrogel layer on the substrate sheet; and separating the apertured hydrogel layer from the substrate sheet.

Description

A7 A7 5 11 經濟部智慧財產局貝工消费合作社印製 ο 2 五、發明說明(/ ) 一 --- 本發明係有關於孔隙水泡脹板片材料,與包括此種板 片材料之傷口敷料。 已知保持微濕的傷口環境可促使傷口癒合,特別是烫 友二長/月的傷口,如··潰瘍,但是傷口上亦欲避免過多的濕 5 氣或傷口流出物之液灘,因為傷口流出物會造成傷口四周 皮膚之人與其他困擾。此外,傷口流出物會自傷口位置 滲漏,而沾污衣服或寢具。 事實上’不易於傷口處*持所欲之濕度,因為傷口液 體的產生速度隨各傷口而異,並且同—傷口隨時間亦會變 10化,故處理不同的傷口必須時常改變敷料與使用不同種類 EP-A-0123456敘述外科敷料使用連續的聚合物膜,豆 係由濕膜較乾膜具有較高水汽滲透性之材料所生成。 ΕΡ Α-087522敘述傷口敷料包括一種具有切割裂縫之 非水泡脹、水無法渗透之孔隙板片,其中⑽板片壓層至 水泡脹之發泡塑料層。吸收傷口液體使得發泡塑料層泡 脹’其導致之變形開啟孔隙板片中之裂縫,因而增加孔隙 板片之液體滲透性。 EP-A-〇m()85敘述傷口敷料具有_種由水泡脹材料麼 層至一較少水泡脹層得到之孔隙板片,其上具有切利裂 縫。使用時’因孔隙板片與其下層之不同泡脹程度促使^ 隙板片之裂縫開啟’故可增加孔隙板片對傷口液體之渗透 性。 US-A-5352508敘述一種塗覆水凝膠材料之孔隙基質 (請先閱讀背面之注意事項再填寫本頁}A7 A7 5 11 Printed by Shelley Consumer Cooperatives, Bureau of Intellectual Property, Ministry of Economic Affairs. 2 V. Description of the Invention (/) I --- The present invention relates to pore-swelling sheet materials and wound dressings including such sheet materials . It is known that maintaining a slightly moist wound environment can promote wound healing, especially wounds that are hot per month, such as ulcers, but also want to avoid excessive moisture on the wound or the fluid beach of the wound exudate, because the wound The exudate can cause skin and other distress to the skin around the wound. In addition, wound exudate can leak from the wound site and contaminate clothing or bedding. In fact, 'it is not easy to maintain the desired humidity at the wound site, because the rate of wound fluid production varies with each wound, and the same-the wound will change over time, so different dressings must often be changed and used differently. EP-A-0123456 describes the use of continuous polymer films for surgical dressings. Beans are produced from materials that have a higher moisture vapor permeability than wet films. EP A-087522 describes that a wound dressing includes a non-water-swellable, water-impermeable porous sheet with a cutting crack, wherein the slab sheet is laminated to a swelled foamed plastic layer. Absorbing the wound fluid causes the foamed plastic layer to swell, which causes deformation to open the cracks in the porous sheet, thereby increasing the liquid permeability of the porous sheet. EP-A-OM (85) describes that a wound dressing has a porous sheet obtained from a layer of water-swelling material to a less water-swelling layer, which has cut slits. In use, 'the difference in the degree of swelling of the porous plate and the underlying layer promotes the opening of cracks in the gap plate', so the permeability of the porous plate to the wound fluid can be increased. US-A-5352508 describes a porous matrix coated with hydrogel material (Please read the precautions on the back before filling this page}

91· 3. 2,000 589337 A7 B7 五、發明說明(及) 10 15 20 織布,用做傷口敷料。 已發現某些孔隙的、自行支承之水凝膠板片,經過水 中泡脹後製得水泡脹板片,其具有較未泡脹板片為高的液 體渗透性,推測此係由於泡脹後增加孔隙之平均面積所致。 因此,本發明提供-種自行支承之孔隙板片,主要包 括一種水舰之水凝膠組成物,其中孔隙佔有低於5〇%之 泡嚴前板片面積。 典型地,孔隙佔有約〇·1%至約5〇%之泡服前板片面積 (以面對傷口之板片面積為較佳),更典型地,佔有約1% 至約30%之泡脹前板片面積,以約1〇%至約25〇/。為較佳, 而以約10%至約20%之泡脹前板片面積為最佳。 孔隙水凝膠板Η使微㈣傷口環㈣持較長的時 間’並涵蓋廣大範圍的傷口渗出速率。#渗出速率較高時, 導致孔隙板片擴張,使其孔隙尺寸增大,故使液體渗透性 增加:板片因此能夠吸除傷口液體,以防止傷口含有過量 的濕氣,而無需移除水凝膠或將水凝膠中之孔隙 各 傷口流出物產生速率下降時,水凝膠板片則會收縮:促: 液體滲透性下降,有助於傷σ表面保持傷口液體。此外, 水凝膠吸收水汽’可用做潤濕劑使之保有微濕的傷口接觸 表面。 於某些實例中,孔隙面積至少增加約25%,例如:藉將 板片泡脹於25。(:之水中6〇分鐘,至少可增加約5〇%。 典型地’每平方公分之板片具有約1至3 0個孔隙,例 如:每平方公分具有約4至約15個孔隙或每平方公分具有 ' 4 本紙張尺度適用中國國家標準(CNS〉A4規格 91. 1. II — — — — — — — — — — — · I I (請先閲讀背面之注意事項再填寫本頁) 經濟部智慧財產局貝工消费合作社印製 589337 A7 I--~------_____ 五、發明說明(3 ) 約5至約10個孔隙。於某些實例中,孔隙均勻分佈於板片 之表面,以規則的圖案為較佳。 以孔隙小者為較佳,因為當水凝膠板片泡脹時,會促 使液體滲透性以最大的比率增加,例如··每個孔隙的平均面 5 積可為約〇·〇ι至約10平方毫米,以約(U至約4平方毫 米為較佳,以約1平方毫米至約2平方毫米為最佳。 …孔隙可具有任何適合的形狀,只要當水凝膠泡脹時可 增加孔隙尺寸,而能增加液體滲透性即可。於一些實例中, 泡脹前孔隙具有最大長度對最大寬度之比率為約丨至約 10 10 ’以約1至約3為較佳,且以約1至約1.5為最佳,適 合的孔隙形狀包括圓形、橢圓形或規則多角形。 孔隙之截面積可貫穿水凝膠板片厚度維持固定(管 狀)’於其他實例中,貫穿板片厚度時孔隙逐漸變小,此則 導致孔隙實質上為斜截圓錐形之形式,此種孔隙可使水由 15 一方向流過板片較由相反方向流過板片為容易。 較佳者,此種孔隙具有底部開口尺寸(孔隙板片最上方 之最大開口尺寸)為G.1毫米至3毫米,與頂點的開口尺寸 (遠至孔隙板片最上方處)為〇·〇5至2毫米,最佳之孔隙具 有依此界定之底部開口尺寸為〇·5毫米至2毫米,與頂點 20 開口尺寸為〇·1至1.0毫米。 孔隙以具有逐漸變小的平均角度(由垂直於孔隙板片 之平面測量)10至60度為較佳。 孔隙水凝膠板片可自行支承,亦即孔隙板片無需將任 何強化或支撐板片、織物、網或物件嵌入或層壓於其中。91 · 3. 2,000 589337 A7 B7 V. Description of the invention (and) 10 15 20 Woven cloth for wound dressing. It has been found that some porous, self-supporting hydrogel sheets are swelled in water to obtain swellable sheets, which have higher liquid permeability than unexpanded sheets. Increased average area of pores. Therefore, the present invention provides a self-supporting porous plate, which mainly includes a hydrogel composition of a watercraft, in which the pores occupy less than 50% of the area of the front panel of the foam. Typically, the pores occupy from about 0.1% to about 50% of the area of the front panel of the blister (preferably the area of the panel facing the wound), and more typically, from about 1% to about 30% of the blister. The area of the panel before swelling is about 10% to about 25%. For the better, about 10% to about 20% of the blistering front panel area is most preferred. Porous hydrogel plates hold micro-wound wounds for a longer period of time 'and cover a wide range of wound exudation rates. #When the exudation rate is high, it causes the pore plate to expand, increasing its pore size, and thus increasing the liquid permeability: the plate can therefore absorb the wound fluid to prevent the wound from containing excessive moisture without removing it. When the hydrogel or the rate of wound exudate production in the pores of the hydrogel decreases, the hydrogel sheet will shrink: promote: the permeability of the liquid will decrease, which will help the wound surface maintain the wound fluid. In addition, the hydrogel absorbs water vapor 'and can be used as a wetting agent to keep the slightly wet wound contact surface. In some instances, the pore area is increased by at least about 25%, for example, by swelling the sheet to 25%. (: 60 minutes in water, it can increase at least about 50%. Typically, the plate has about 1 to 30 pores per square centimeter, for example: about 4 to about 15 pores per square centimeter or per square centimeter. The centimeter has' 4 paper standards applicable to Chinese national standards (CNS> A4 specification 91. 1. II — — — — — — — — — — — II (Please read the notes on the back before filling this page) Wisdom of the Ministry of Economic Affairs Printed by the Shellfish Consumer Cooperative of the Property Bureau 589337 A7 I-- ~ ------_____ V. Description of the invention (3) About 5 to about 10 pores. In some examples, the pores are evenly distributed on the surface of the panel It is better to use a regular pattern. The one with smaller pores is better, because when the hydrogel sheet swells, it will cause the liquid permeability to increase at the maximum rate, such as the average area of 5 pores per pore. It may be about 0.00 to about 10 square millimeters, preferably about (U to about 4 square millimeters, and most preferably about 1 square millimeter to about 2 square millimeters.… The pores may have any suitable shape as long as When the hydrogel is swelled, it can increase the pore size and increase the liquid permeability. Yes, in some examples, the ratio of the maximum length to the maximum width of the pores before inflation is about 1 to about 10 10 ′, preferably about 1 to about 3, and most preferably about 1 to about 1.5. The shape of the pores includes round, oval, or regular polygons. The cross-sectional area of the pores can be fixed through the thickness of the hydrogel sheet (tubular). In the form of an oblique truncated cone, this type of pores makes it easier for water to flow through the plate from one direction than through the plate in the opposite direction. Preferably, such pores have a bottom opening size (pore plate The maximum opening size at the top is G.1 mm to 3 mm, and the opening size at the apex (as far as the top of the pore plate) is 0.05 to 2 mm. The best pore has a bottom defined as such The opening size is 0.5 mm to 2 mm, and the apex 20 opening size is 0. 1 to 1.0 mm. The pores are at an angle of 10 to 60 degrees with a gradually decreasing average angle (measured from a plane perpendicular to the pore plate). Pore hydrogel sheets are available Line support, i.e., the aperture plate without any reinforcing or supporting sheet, a fabric, or a laminate web or an object embedded therein.

- 訂·!:------線泰 (請先JH讀背面之注意事項再填寫本頁)-Ordered! : -------- Xiang Tai (Please read the precautions on the back of JH before filling this page)

本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 91. 3. 2,000 經濟部智慧財產局S工消費合作社印製 589337This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) 91. 3. 2,000 Printed by S Industrial Consumer Cooperative, Intellectual Property Bureau, Ministry of Economic Affairs 589337

五、發明說明(+ ) 孔隙水凝膠板片一般主要包括如下所述之水凝膠組成物。 當然,板片自行支承之性能意含水凝膠組成物具有一最低 限度之内在力量,較佳的水凝膠組成物(依照astm4i2, 於-連續的細長片(2·5么v分寬)上測定)具有斷裂力量〇·5 5 至丨〇牛頓,最佳者為1至5牛頓。 孔隙板片之厚度(依照ASTM D374_79)以約〇·2至約4 耄米為較佳,以約〇·4至喲2毫米為最佳。水凝膠層具有 之乾燥基準重量,以約10至約1〇〇〇公克/平方公尺為較 佳,以約20至約200公克/平方公尺為更佳,以約4〇至約 10 丨⑼公克/平方公尺為最佳。 “水泡脹水凝膠組成物,,一詞係指組成物,其於生理的溫 度與pH條件下可吸收水,而與水生成一種凝膠,此種組 成物包括醫學上可接受的大分子材料,其具有泡脹能力, 並可吸收傷口液體,同時保持堅固的整體結構。通常,水 15 凝膠組成物實質上於生理條件下不溶於水,故水凝膠不會 被傷口液體洗除。水凝膠可包括一種生物聚合物,亦即其 可由一種自然界存在之聚合物生成,如:膠原、明膠或藻 膠。水凝膠可為生物吸收性,亦即可於其本體内緩慢地進 行再吸收。 20 典型地,依本發明之孔隙板片沉浸於25°C之水中60分 鐘後,以沉浸前板片重量為基準,至少吸收約1〇重量/重 1 /〇之水,以至少約25重量/重量%之水為較佳,以至少約 5〇重量/重量%之水為更佳,並以至少約1〇〇重量/重量% 之水為最佳。 (請先閱讀背面之注意事項再填寫本頁)V. Description of the invention (+) The porous hydrogel sheet generally mainly includes a hydrogel composition as described below. Of course, the self-supporting performance of the plate means that the hydrogel composition has a minimum intrinsic strength, and the preferred hydrogel composition (according to astm4i2, is on a continuous elongated sheet (2 · 5mm width) (Measurement) has a breaking force of 0.5 5 to 10 Newton, and the best is 1 to 5 Newton. The thickness of the porous plate (according to ASTM D374_79) is preferably about 0.2 to about 4 mm, and most preferably about 0.4 to 2 mm. The dry basis weight of the hydrogel layer is preferably about 10 to about 1,000 g / m 2, more preferably about 20 to about 200 g / m 2, and about 40 to about 10 g.丨 ⑼g / m² is the best. "Blister hydrogel composition, the term refers to a composition that absorbs water at physiological temperature and pH conditions, and forms a gel with water. Such a composition includes medically acceptable macromolecules Material, which has the ability to swell, and can absorb wound fluid while maintaining a solid overall structure. Generally, the hydrogel composition is substantially insoluble in water under physiological conditions, so the hydrogel will not be washed away by the wound fluid. Hydrogel can include a biopolymer, that is, it can be produced from a polymer that exists in nature, such as collagen, gelatin, or algin. Hydrogel can be bioabsorbable, that is, it can be slowly in its body. Re-absorption. 20 Typically, the porous sheet according to the present invention is immersed in water at 25 ° C for 60 minutes, and then absorbs at least about 10 weight / weight 1 / 〇 of water based on the weight of the sheet before immersion. Water of at least about 25 wt / wt% is preferred, water of at least about 50 wt / wt% is more preferred, and water of at least about 100 wt / wt% is most preferred. (Please read the back first (Notes to fill out this page)

本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 91. 3. 2,000 經濟部智慧財產局貝工消费合作社印製 589337 A7 五、發明說明(g ) 不>谷於水之凝膠之示範包括一些交聯的聚丙烯酸酯凝 膠,如敘述於EP-A-0676457中者、鈣藻膠、交聯的琉璃 醣石厌基酸醋凝膠、藻膠衍生物,如:丙二醇藻膠,之凝膠, 與凝膠,其中氫化聚合物之生成源自:乙烯基醇類、乙烯基 5 酯類、乙烯基醚類與羧基乙烯基單體、甲基丙烯酸、丙烯 醯胺、N-乙烯基吡咯烷酮、醯基醯胺基丙烷磺酸、 PLURONIC(註冊商標)(嵌段聚乙二醇、嵌段聚丙二醇)聚苯 乙烯…馬來酸、N,N-二曱基丙烯醯胺、二丙酮丙烯醯胺、 丙烯醯嗎啉,與其混合物,適合的水凝膠亦敘述於 10 US-A-5352508。 較佳之水凝膠組成物包括一種大分子材料,選自:聚胺 基甲酸醋凝膠、生物聚合物凝膠、叛基甲基纖維素凝膠、 羥基乙基纖維素凝膠、羥基丙基甲基纖維素、聚丙烯酸酯, 與其混合物’適合的生物聚合物凝膠包括:藻膠、果膠、明 15膠,半乳甘露聚醣,如:古阿與黃酸、聚甲殼糖、明膠、琉 璃醣碳基酸醋,與其混合物,這些生物聚合物材料中有 些亦能促使傷口癒合。 凝膠以化學或物理的交聯為較佳,而化學交聯可為乒 價或離子性。 ^ 20 以泡脹前之板片重量為基準,孔隙板片可包括至少5〇 重ϊ/重置%之膠生成大分子材料,以至少約75重量/重量 %為較佳。於相同基準下,水凝踢材料可另外包括約5至 約50重量%,以15至4〇重量%為較佳之一種或多種保 濕劑,如:甘油。於相同基準下,水凝㈣料可另外包含至 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公"i 91· 3. 2,000 (請先閲讀背面之注意事項再填寫本頁) I ^---I----^--------- 經濟部智慧財產局貝工消费合作社印製 589337 A7 B7_ 五、發明說明(G ) 多約30重量/重量%,以至多約15重量/重量%為較佳,之 水0 以泡脹前之組成物重量為基準,水凝膠組成物可另外 包括至多約10重量/重量%,以0.1至5重量/重量%為較 5 佳,之醫療品。適合的醫療品包括防腐劑,如:磺胺達嗪銀、 氣己定(chlorhexidine)、二氣苯氧氣齡(triclosan)或聚烯口比 酮(povidone)蛾、止痛藥、類固醇、抗生素、生長素,或其 混合物。依本發明孔隙板片以實質上無菌者為較佳。 依本發明孔隙板片於有些實例中為具黏著性,於有些 1〇 實例中,板片之水凝膠組成物本身即具有黏著性。於其他 實例中,可將醫學上可接受之感壓黏著劑塗敷於孔隙板片 之表面。 於某些實例中,水凝膠層包括一種交聯的聚丙烯酸酯 水凝膠材料,例如:一種如EP-A-0676457、WO 00/0763 8 15 或WO 00/45866中敘述之材料,其全文納入本文供參考。 本發明另外提供一種傷口敷料,其包括依本發明之孔 隙板片。 較佳之傷口敷料除孔隙板片外,包括一吸收層與/或一 支持層,於此案例中,孔隙板片做為敷料之面對傷口最上 2〇 層為較佳。 較佳者,敷料另外於孔隙板片之背面包括一支持層, 此支持層以能對微生物通過敷料之通道提供障礙為較佳, 並以能阻擋傷口液體由敷料流出為較佳。支持層至少延伸 於吸收層之一邊,以於緊鄰前述之一邊處提供塗覆黏著劑 ' 8 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 91. 3. 2,000 (請先閱讀背面之注意事項再填寫本頁) · ϋ n ϋ n an n n^OJ· n n I n —i n- 經濟部智慧財產局員工消t合作社印製 589337 A7 B7 五、發明說明(7 ) 之邊緣,以將敷料黏著至一表面,如:至病人緊鄰所處置傷 口之皮膚。塗覆黏著劑之邊緣可延伸至吸收層之四側,因 此使得敷料成為所謂的島狀敷料,然而,並非必須要有任 何塗覆黏著劑之邊緣。 5 支持層以實質上不滲透液體為較佳,支持層以半滲透 為較佳,此即支持層以可滲透水汽,但不渗透水液或傷口 流出物為較佳,支持層亦以不滲透微生物為較佳。適合的 連續一致支持層,於37.5°C與100%至10%相對濕度下, 以單獨支持層具有300至5000公克/平方公尺/24小時之水 1〇 汽穿透速率(MVTR)為較佳,以500至2000公克/平方公尺 /24小時為最佳。支持層的厚度以於10至1000微米之範 圍為較佳,以100至500微米為最佳。 依本發明敷料之整體具有較單獨支持層為低之 MVTR,因為孔隙板片部份地阻礙水汽穿越敷料,敷料之 15 MVTR(跨越敷料島部份之測定)以單獨支持層MVTR之 20%至80%為較佳,以20%至60%為更佳,以約40%為最 佳。已發現此水汽穿透速率可使敷料下之傷口於微濕情況 下癒合,而不會使傷口四周之皮膚浸軟。 適合用於生成支持板片之聚合物包括:聚胺基甲酸酯與 2〇 聚烷氧基烷基丙烯酸酯與甲基丙烯酸酯,如GB-A-1280631 所揭示者。支持層以包括高密度封端聚胺基甲酸酯發泡塑 料,主要為閉孔,之連續層為較佳,一種適合的支持板片 材料為具註冊商標ESTANE 5714F之市售聚胺基甲酸酯薄 膜0 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公芨) 91. 3. 2,000 (請先閲讀背面之注意事項再填寫本頁)This paper size applies Chinese National Standard (CNS) A4 (210 X 297 mm) 91. 3. 2,000 Printed by Shelley Consumer Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs 589337 A7 V. Description of Invention (g) Not > Gu Yushui Examples of gels include cross-linked polyacrylate gels, such as those described in EP-A-0676457, calcarein, cross-linked glucosamine anaerobic acid gels, alginate derivatives, such as : Propylene glycol algal gel, gel, and gel, in which the generation of hydrogenated polymers is derived from: vinyl alcohols, vinyl 5 esters, vinyl ethers and carboxy vinyl monomers, methacrylic acid, acrylic acid Amine, N-vinylpyrrolidone, fluorenylamidopropanesulfonic acid, PLURONIC (registered trademark) (block polyethylene glycol, block polypropylene glycol) polystyrene ... maleic acid, N, N-difluorenyl Acrylamide, diacetone acrylamide, acrylmorpholine, and mixtures thereof, suitable hydrogels are also described in 10 US-A-5352508. A preferred hydrogel composition includes a macromolecular material selected from the group consisting of: polyurethane gel, biopolymer gel, methyl cellulose gel, hydroxyethyl cellulose gel, hydroxypropyl Methylcellulose, polyacrylates, and mixtures thereof. Suitable biopolymer gels include: algin, pectin, gelatine 15, galactomannan, such as: Gua and flavonic acid, polychitosan, gelatin , Glass sugar vinegar, and its mixture, some of these biopolymer materials can also promote wound healing. The gel is preferably chemically or physically cross-linked, and chemical cross-linking may be pingvalent or ionic. ^ 20 Based on the weight of the sheet before inflation, the porous sheet can include at least 50 weight percent / reset% of gel-forming macromolecular material, and preferably at least about 75 weight / weight%. On the same basis, the hydraulic kick material may further include about 5 to about 50% by weight, and preferably 15 to 40% by weight of one or more moisture retention agents, such as glycerin. Under the same standard, hydraulic aggregates can be additionally included to this paper size. Applicable to China National Standard (CNS) A4 specification (210 X 297 male " i 91 · 3. 2,000 (Please read the precautions on the back before filling this page) ) I ^ --- I ---- ^ --------- Printed by Shellfish Consumer Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs 589337 A7 B7_ V. Description of the invention (G) 30% / wt% more, It is preferably at most about 15% by weight / weight%. Water 0 is based on the weight of the composition before inflation. The hydrogel composition may further include at most about 10% by weight / weight%, at 0.1 to 5% by weight / weight%. Medical products that are better than 5. Suitable medical products include preservatives, such as silver sulfadazine, chlorhexidine, triclosan, or povidone moth, Analgesics, steroids, antibiotics, auxins, or mixtures thereof. The porous plate according to the invention is preferably substantially sterile. The porous plate according to the invention is adhesive in some examples and in some 10 examples. The hydrogel composition of the plate itself has adhesiveness. In other examples, the medical An acceptable pressure-sensitive adhesive is applied to the surface of the porous sheet. In some examples, the hydrogel layer includes a cross-linked polyacrylate hydrogel material, such as: EP-A-0676457, The materials described in WO 00/0763 8 15 or WO 00/45866 are incorporated herein by reference in their entirety. The present invention further provides a wound dressing comprising a porous sheet according to the present invention. Preferred wound dressings other than the porous sheet It includes an absorbent layer and / or a support layer. In this case, it is better for the porous sheet to be the top 20 layers facing the wound. More preferably, the dressing additionally includes a support on the back of the porous sheet. This support layer is better to provide a barrier to the passage of microorganisms through the dressing, and it is better to prevent wound fluid from flowing out of the dressing. The support layer extends at least on one side of the absorbent layer and is provided immediately adjacent to the aforementioned one. Coating Adhesive '8 This paper size is applicable to Chinese National Standard (CNS) A4 (210 X 297 mm) 91. 3. 2,000 (Please read the precautions on the back before filling this page) · · n ϋ n an nn ^ OJ · nn I n i n- Printed by the staff of the Intellectual Property Bureau of the Ministry of Economic Affairs and printed by the cooperative 589337 A7 B7 V. The edge of invention description (7) to adhere the dressing to a surface, such as: to the skin of the patient next to the wound being treated. Apply adhesive The edges can extend to the four sides of the absorbent layer, so that the dressing is a so-called island dressing, however, it is not necessary to have any adhesive-coated edges. 5 The support layer is preferably substantially impermeable to liquid, the support layer It is better to use semi-permeable, that is, the support layer is permeable to water vapor, but it is not permeable to water or wound exudate, and the support layer is also to be permeable to microorganisms. Suitable continuous and consistent support layer, at 37.5 ° C and 100% to 10% relative humidity, a single support layer with 300 to 5000 g / m² / 24 hour water vapor transmission rate (MVTR) is The best is 500 to 2000 g / m² / 24 hours. The thickness of the support layer is preferably in the range of 10 to 1000 microns, and most preferably 100 to 500 microns. According to the present invention, the dressing as a whole has a lower MVTR than the individual support layer, because the porous sheet partially hinders water vapor from passing through the dressing, and the 15 MVTR of the dressing (measured across the island of the dressing) is 20% to MVTR of the separate support layer. 80% is better, 20% to 60% is better, and about 40% is best. It has been found that this water vapor penetration rate allows the wound under the dressing to heal in a slightly moist condition without macerating the skin around the wound. Polymers suitable for use in the production of support plates include: polyurethanes and 20 polyalkoxyalkyl acrylates and methacrylates, as disclosed in GB-A-1280631. The support layer consists of high-density end-capped polyurethane foam, mainly closed cells. A continuous layer is preferred. A suitable support sheet material is a commercially available polyurethane with registered trademark ESTANE 5714F. Ester film 0 This paper size is applicable to China National Standard (CNS) A4 (210 X 297 cm) 91. 3. 2,000 (Please read the precautions on the back before filling this page)

A7 經濟部智*財產局貝Η消费合作社印製 五、發明說明(y) 、黏著層(右存在)應具有水汽穿透性與/或具有圖案以形 成尺π穿越之通道,黏著層以一種具有連續的水汽穿透 14感壓之黏著層,其為習用之島形傷口敷料者為較佳, 例如:-種感壓黏著劑,其基f為丙烯酸_共聚物、聚乙稀 基^基_與聚胺基甲酸醋,如GB_A]280631巾所述者。 黍著層之基準重量以20至250公克/平方公尺為較佳,以 5〇至150公克/平方公尺為最佳,以聚胺基甲酸酯為基質 之感壓黏著劑為較佳。 較佳者為:黏著層由吸收層向外延伸,而且於支持層外 圍形成塗覆黏著劑之邊沿,包圍黏著層如習知之島敷料。 選擇地吸收層之面積典型地於〖平方公分至2〇〇平方 公分之範圍,以4平方公分至100平方公分為較佳。 選擇地吸收層可為任何於傷口癒合技藝中習知用以吸 收傷口液體、血清或血液之層,包括二紗布、不織布、強力 吸收劑、水凝膠與其混合物,較佳者為吸收層包括一吸收 發泡塑料層,如:一種依照EP_冬〇541391製造之開孔親水 性聚胺基甲酸酯發泡塑料,特將其全文納入本文供參考。 於其他實例中,吸收層可為一種不織布之網,例如二種黏 著鉤環織布之梳理網。吸收層之基準重量可於5〇至 公克/平方公尺之範圍,如:100至4〇〇公克/平方公尺。吸 收層之未壓縮厚度可於〇·5毫米至1〇毫米之範圍T如:丨毫 米至4毫米。在25°C下,以生理鹽水測定之自然(未壓縮) 液體吸收量可於5至30公克/公克之範圍。 、 依本發明之傷口敷料以無菌並且包裝於微生物無法滲 5 10 15 20 91. 3. 2,000 n 1 n n n 1 1 n 1 n It -I I · n 1· (請先》讀背面之注意事項再填寫本頁) *φ -A7 Printed by the Intellectual Property Bureau of the Ministry of Economic Affairs, the Beiya Consumer Cooperative. V. Invention Description (y) The adhesive layer (existing on the right) should have water vapor permeability and / or be patterned to form a channel through which the π crosses. It has a pressure-sensitive adhesive layer with continuous water vapor penetration 14, which is preferred for conventional island-shaped wound dressings. For example:-a pressure-sensitive adhesive, whose base f is acrylic copolymer, polyethylene based _ With polyurethane, as described in GB_A] 280631. The reference weight of the anchoring layer is preferably from 20 to 250 g / m 2, most preferably from 50 to 150 g / m 2, and a pressure-sensitive adhesive based on polyurethane is preferred. . Preferably, the adhesive layer extends outward from the absorbing layer, and forms an edge for applying an adhesive on the periphery of the support layer, and surrounds the adhesive layer such as a conventional island dressing. The area of the selective absorption layer is typically in the range of from ^ 2 to ^ 2, and preferably from 4 to 100 cm2. The selective absorbent layer may be any layer conventionally used in wound healing techniques to absorb wound fluid, serum, or blood, including two gauze, non-woven fabrics, strong absorbents, hydrogels, and mixtures thereof, preferably the absorbent layer includes a An absorbent foamed plastic layer, such as an open-celled hydrophilic polyurethane foam made in accordance with EP_Winter 541391, is hereby incorporated by reference in its entirety. In other examples, the absorbent layer may be a non-woven mesh, such as two carded meshes with hook and loop woven fabrics. The reference weight of the absorbing layer can be in the range of 50 to g / m2, such as 100 to 400 g / m2. The uncompressed thickness of the absorbent layer can range from 0.5 mm to 10 mm, such as: 丨 mm to 4 mm. The natural (uncompressed) liquid absorption measured at 25 ° C in normal saline can range from 5 to 30 g / g. The wound dressing according to the present invention is sterile and packaged in a way that cannot be penetrated by microorganisms 5 10 15 20 91. 3. 2,000 n 1 nnn 1 1 n 1 n It -II · n 1 · (Please read the precautions on the back before filling (This page) * φ-

589337 經濟部智慧財產局員工消貧合作社印製 A7 B7 五、發明說明(1) 透之容器中為較佳。 於另一層面,本發明提供一種製造孔隙板片之方法, 包括下列步驟: 提供一種孔隙基質之板片; 5 將一種水溶性水凝膠前驅物塗覆於孔隙基質上; 將基質上之水溶性水凝膠前驅物熟化,以於基質板片 上生成孔隙水凝膠層;與 將交聯的水凝膠層自基質板片分離。 較佳之基質板片為穿孔的熱塑性薄膜,如:PTFE薄膜 10 或t乙浠薄膜或乙烯乙酸乙烯酯(EVA)薄膜,以真空穿孔 之薄膜為較佳,例如:敘述於GB-A-i 526778之孔隙逐漸變 小之薄膜。於其他實例中,基質板片可為一種穿孔的金屬 或塑膠板,或金屬或熱塑性細線之網目。於一些實例中, 基質板片可使用剝離塗層,如··矽樹脂剝離塗層,加以塗 15 覆,以輔助孔隙板片產物自基質剝離。 水凝膠前驅物為一種預凝膠組成物,其於冷卻、聚合 反應或交聯後可生成非水溶性的水凝膠,實例包括:水溶性 的鈉藻膠,其可藉鈣鹽結膠,另一實例為古阿膠,其可藉 硼酸鹽結膠,於其他實例中,預凝膠為可熟化之組成物, 20 其包括一種或多種單體與典型地一種或多種交聯劑與/或 聚合反應引發劑。較佳之單體為丙烯酸酯,如:甲基丙浠酉曼 2-經基乙基酯,丙稀醢胺,如:n,N-二甲基丙烯醢胺,同樣 較佳者為2-丙稀酿胺-2-甲基丙烧績酸之鹽類或ci至C5 δ旨類之混合物’與丙稀酸(3-確丙基)g旨之鹽類或ci至C5 ' 11 本紙張尺度適用中國國家楳準(CNS)A4規格(210 X 297公釐) 91· 3. 2.000 (請先閲讀背面之注意事項再填寫本頁)589337 Printed by the Anti-Poverty Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 V. Description of the invention (1) It is better to put it in a transparent container. In another aspect, the present invention provides a method for manufacturing a porous sheet, including the following steps: providing a sheet of a porous matrix; 5 coating a water-soluble hydrogel precursor on the porous matrix; The mature hydrogel precursor is matured to generate a porous hydrogel layer on the matrix plate; and the hydrogel layer to be crosslinked is separated from the matrix plate. The preferred substrate sheet is a perforated thermoplastic film, such as: PTFE film 10 or t-acetylene film or ethylene vinyl acetate (EVA) film. Vacuum-perforated films are preferred, for example: the pores described in GB-Ai 526778 Thinning film. In other examples, the substrate sheet may be a perforated metal or plastic sheet, or a mesh of metal or thermoplastic threads. In some examples, the substrate sheet may be coated with a release coating, such as a silicone release coating, to assist the release of the porous sheet product from the substrate. A hydrogel precursor is a pre-gel composition that can form a water-insoluble hydrogel after cooling, polymerization, or cross-linking. Examples include: water-soluble sodium alginate, which can be cemented with calcium salts. Another example is ancient gum, which can be gelled by borate. In other examples, the pregel is a composition that can be cured. 20 It includes one or more monomers and typically one or more crosslinking agents and / Or polymerization initiator. The preferred monomers are acrylates, such as: methamphetamine 2-meryl ethyl ester, propylamine, such as: n, N-dimethylacrylamide, and the same is preferably 2-propane Mixture of dilute amine-2-methylpropionate salts or ci to C5 δ purpose 'and salts of acrylic acid (3-propane) g or ci to C5' 11 Size of this paper Applicable to China National Standard (CNS) A4 (210 X 297 mm) 91 · 3. 2.000 (Please read the precautions on the back before filling this page)

589337 A7 _ B7 五、發明說明() 烷基酯類。適合的交聯劑為聚乙烯乙二醇二丙烯酸酯,適 合的交聯引發劑為習用之過氧化物引發劑。 (請先閲讀背面之注意事項再填窝本頁) 適合的預凝膠材料為可用紫外線熟化之聚丙烯酸酯預 凝膠,如WO 00/65143所述,其全文納入本文供參考。 5 較佳者為將預凝膠之黏度加以調整,以供給所欲預凝 膠層於基質上之厚度。 可藉如:喷霧或縫形塗覆或擠塑或使用醫用刀片將預凝 膠塗覆於基質表面。孔隙可於預凝膠塗覆層中生成,例如: 可於跨越塗覆之基質施加氣體壓差,以於塗覆層吹塑孔 1〇 隙’此種一般形式之方法敘述於如:WO 93/19709,或者亦 可於孔隙基質上塗覆一種孔隙水凝膠,如:W〇 〇〇/65143 所述,其全文納入本文供參考。 孔隙水凝膠板片以藉剝離將其自基質分開為較佳。 於另一層面,本發明提供一種處理傷口之方法,其包 15 括:施加依本發明之敷料於傷口表面之步驟,經由孔隙水凝 膠板片接觸傷口。 本發明之特殊實例現藉舉例方式加以進一步述說。 實例1 經濟部智慧財產局貝工消f合作社印製 ο 2 依下法製備一種依本發明之孔隙水凝膠板片。 、,提:-種基質板片,其包括一種聚乙烯薄膜,其上每 平方A刀、、、勺牙有10個孔洞,每個孔洞如前述般實質上為圓 錐形,最大孔徑約為^毫米,開孔面積為正面總面積之 16〇/〇 ’重里厚度約為43微米,與壓花厚度約為〇·5毫米。 本紙張尺度適財關家標準(CNS)A4 297公釐) 2.000 589337 A7 經濟部智慧財產局貝工消費合作社印製 五、發明說明(// ) 此種穿孔板片可獲自Tredegar薄膜產品公司,Richm〇nd, 維吉尼亞州,註冊商標為VISPORE。 基質板片為一平滑、穿孔之上部表面,而後於其表面 藉喷霧塗覆一層氫化聚合物預凝膠6,此預凝膠包括牛的 凝膠於約25°C水中。將凝膠濃度調整於5至2〇重量/重量 %之範圍使提供所欲之黏度,以得到均勻、於其基質上意 欲尽度之黏著層。隨後於基質之背面施加吸力,將預凝膠 層真空穿孔,以於基質中標記孔洞。而後藉戊二搭或甲駿 之處理將凝膠交聯,交聯之凝膠板片於4(rc乾燥後,再將 其自基質板片剝離。 獲得之水凝膠板片具有的乾燥基準重量為1〇〇公克/平 方公尺,並且包括牛的凝膠與戊二醛或甲醛相交聯,此板 片每平方公分具有約1〇個孔洞,每個孔洞具有最大孔徑約 於〇·8至1.2毫米之範圍,促使開孔面積約為孔隙板片總 面積之5至10%。25°C下浸泡於水中i小時後,凝膠已泡 脹但未浴解,而且可見其孔洞增大,板片之液體滲透性因 而增加。 板片可於包裝供直接使用,或可製成依本發明之多層 傷口敷料,其可使用伽馬射線予以滅菌。 使用時將敷料自包裝取出,並將孔隙水凝膠板片敷於 傷口,使其水凝膠與傷口接觸,以提供無菌與具吸收性之 敷料水凝膠板片迄今以意料外之互動^式於一段相當 的J間,對於廣泛範圍的傷口提供微濕,但不會濕潤傷口 之周圍環境。 ' 5 10 15 20 13 (請先Mtt背面之注意事項再填寫本頁)589337 A7 _ B7 V. Description of the invention () Alkyl esters. A suitable cross-linking agent is polyethylene glycol diacrylate, and a suitable cross-linking initiator is a conventional peroxide initiator. (Please read the notes on the back before filling this page.) A suitable pregel material is a UV-curable polyacrylate pregel, as described in WO 00/65143, which is incorporated herein by reference in its entirety. 5 It is preferred to adjust the viscosity of the pregel to provide the desired thickness of the pregel layer on the substrate. Pregels can be applied to the surface of the substrate by spray or slit coating or extrusion, or using a medical blade. Pores can be generated in the pre-gel coating layer, for example: a gas pressure differential can be applied across the coated substrate to blow holes 10 gaps in the coating layer. This general form of method is described in, for example, WO 93 / 19709, or a pore hydrogel can also be coated on the pore matrix, as described in 5000/65143, which is incorporated herein by reference in its entirety. The porous hydrogel sheet is preferably separated from the matrix by peeling. In another aspect, the present invention provides a method for treating a wound, which comprises the steps of applying a dressing according to the present invention to a wound surface, and contacting the wound through a porous hydrogel sheet. Specific examples of the present invention will now be described by way of example. Example 1 Printed by Bei Gong Xiao F Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs 2 A porous hydrogel sheet according to the present invention was prepared according to the following method. A: A substrate sheet comprising a polyethylene film, each of which has 10 holes per square A knife, spoon, and each hole is substantially conical as described above, with a maximum aperture of approximately ^ Mm, the area of the opening is 16/0 ′ of the total area of the front surface, and the thickness is about 43 microns, and the thickness of the embossing is about 0.5 mm. This paper is suitable for financial standards (CNS) A4 297 mm) 2.000 589337 A7 Printed by Shelley Consumer Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs 5. Description of the invention (//) Such perforated sheet can be obtained from Tredegar Film Products Company , Richmond, Virginia, registered trademark is VISPORE. The matrix plate is a smooth, perforated upper surface, and then a spray-coated layer of hydrogenated polymer pregel 6 is applied to the surface. The pregel includes bovine gel in about 25 ° C water. The gel concentration is adjusted in the range of 5 to 20% by weight / weight% so as to provide a desired viscosity to obtain a uniform adhesive layer which is intended to be used on the substrate as much as possible. A suction is then applied to the back of the substrate, and the pre-gel layer is vacuum perforated to mark holes in the substrate. Then the gel was cross-linked by the treatment of glutarine or Jiajun. After the cross-linked gel sheet was dried at 4 ° C, it was peeled from the matrix sheet. The obtained hydrogel sheet had a drying standard It weighs 100 g / m² and includes a gel of bovine cross-linked with glutaraldehyde or formaldehyde. This plate has about 10 holes per square centimeter, and each hole has a maximum pore size of about 0.8 In the range of 1.2 mm, the opening area is about 5 to 10% of the total area of the porous plate. After soaking in water for 25 hours at 25 ° C, the gel has swelled but has not bathed, and its pores can be seen to increase. Therefore, the liquid permeability of the plate is increased. The plate can be directly used in packaging, or can be made into a multi-layer wound dressing according to the present invention, which can be sterilized using gamma rays. When using, remove the dressing from the package and remove The porous hydrogel sheet is applied to the wound, and the hydrogel is brought into contact with the wound to provide a sterile and absorbent dressing. The hydrogel sheet has so far unexpectedly interacted in a comparable section of J. For a wide range of Range of wounds provide slightly moist but do not wet the wound Nearby '510152013 (Please Note the back surface of the page and then fill Mtt)

91. 3. 2,000 589337 經濟部智慧財產局貝工消貧合作社印製 A7 —-------B7 五、發明說明(丨1) 實例2 由聚乙烯基吡咯烷酮(PVP)凝膠生成之依本發明孔隙 板片係由下示預凝膠配方製得: PVP 20% 5 水 79.16% 甲墓仲班 0.25% 乙基仲班 0.03% 丙基仲班 0.05% 丁基仲班 0.01% 10 2-苯氧基乙醇 0.50% 由此生成之凝膠溶液隨後經由縫形塑模擠塑至一與實 例1相同種類之基質板片上,以5公尺/分鐘之速度移動, 塗覆重量為1000公克/平去公尺,依實例i所述方法施加 15 吸力,以於預凝膠穿孔。 其後藉穿越60°C之烘箱將預凝膠熟化,得到之熟化水 凝膠層再於40°C乾燥,並將其自基質剝離。 實例3 20 製備一 PTFE塑模’其每間隔3毫米具有圓錐形凸出 物’凸出物之高度為3毫米,底部直徑2毫米與圓錐形頂 部直徑1毫米。將塑模充填一種依下法製備之聚丙烯酸酯 單體溶液:80毫升製自50重量/容積%之2_丙烯醯胺甲 基丙烷磺酸、20毫升水、5毫升氣化鉀(5重量/容積%)、 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公« ) (請先Μ讀背面之注意事項再填寫本頁)91. 3. 2,000 589337 A7 printed by Shellfish Anti-Poverty Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs ----------- B7 V. Description of the Invention (丨 1) Example 2 Produced from polyvinylpyrrolidone (PVP) gel The pore plate according to the present invention is prepared by the following pre-gel formula: PVP 20% 5 water 79.16% Acetone 0.25% Ethyl secondary 0.03% Propyl secondary 0.05% Butyl secondary 0.01% 10 2-benzene The resulting gel solution was then extruded through a slot mold onto a substrate of the same type as in Example 1, and moved at a speed of 5 meters / minute, with a coating weight of 1,000 grams / square. Remove the meter and apply 15 suction as described in Example i for pregel perforation. After that, the pregel was cured by passing through an oven at 60 ° C, and the obtained cured hydrogel layer was dried at 40 ° C and peeled from the substrate. Example 3 20 A PTFE mold was prepared. The height of the protrusions was 3 mm, the diameter of the bottom was 2 mm, and the diameter of the top of the cone was 1 mm. Fill the mold with a polyacrylate monomer solution prepared in the following way: 80 ml of 2-propenylamine methylpropanesulfonic acid made from 50 wt / vol%, 20 ml of water, 5 ml of potassium gaseous (5 weight / Volume%), this paper size applies Chinese National Standard (CNS) A4 specification (210 X 297 male «) (Please read the precautions on the back before filling this page)

91. 3. 2,000 589337 A7 五、發明說明(Λ3 ) 〇·15毫升1自2G& PEG4GG與6份1·經基環己基苯基嗣之 溶液。 單體溶液藉曝露於紫外光予以聚合,並將聚合的凝膠 自塑核剝離,以提供_種自行支承之孔隙凝膠。 5 刖述實例僅是為舉例而加敘述,許多於伴隨申請專利 範圍内之其他實例對於專精之讀者應屬顯見。 (請先Mtt背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印製 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公芨) 91. 3. 2,00091. 3. 2,000 589337 A7 V. Description of the invention (Λ3) 0.15 ml of a solution of 1g 2G & PEG4GG and 6 parts of 1xylcyclohexylphenylfluorene. The monomer solution was polymerized by exposure to ultraviolet light, and the polymerized gel was peeled from the plastic core to provide a self-supporting porous gel. 5 Descriptive examples are provided for illustration only, and many other examples within the scope of the accompanying patent application should be obvious to the specialized reader. (Please fill in the notes on the back of Mtt before filling out this page.) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs. This paper size applies to China National Standard (CNS) A4 (210 X 297 cm) 91. 3. 2,000

Claims (1)

專利申請案第91116522號 ROC Patent Appln. No. 91116522 修正之申請專利範圍中文本-附件(一) - Amended Claims in Chinese - Enci .(T) 5 (民國92年8月曰送呈) (Submitted on August ιζ 2003) 1· 一種自行支承之孔隙板片,主要包括一種水泡脹之水 凝膠組成物,其中孔隙面積為板片泡脹前面積之〇.1〇/。 10 至 50%。 2·根據申請專利範圍第1項之孔隙板片,其每平方公分 具有1至3 0個孔隙。 3·根據申請專利範圍第1或2項之孔隙板片,其中每個 孔隙的平均面積為〇·〇1至4平方毫米。 15 4.根據申請專利範圍第1或2項之孔隙板片,其中泡脹 前孔隙具有長度對寬度之比率為自1至10。 5·根據申請專利範圍第1項之孔隙板片,其中藉將板片 於25°C之水中沉浸60分鐘,其孔隙面積至少増加5〇 %。 20 6·根據申請專利範圍第1或5項之孔隙板片,其中水泡 經濟部智慧財產局員工消費合作社印製 脹水凝膠組成物,其2.5公分寬之細長片具有抗張強 度2至5牛頓。 7.根據申請專利範圍第1或5項之孔隙板片’其中孔隙 自板片前方表面至後方表面逐漸變小。 -25 8·根據申請專利範圍第1或5項之孔隙板片’其中板片 沉浸於25°C之水中60分鐘,以沉浸前板片重量為基 準,板片吸收50重量/重量%至1〇〇重量/重量%之 水。 . -16 - 本紙張尺度適用中國國家標準(CNS)A4規格(210x297公釐)91330B-接 589337 A8 B8 C8 _D8_ 六、申請專利範圍 9. 根據申請專利範圍第1或5項之孔隙板片,其中板片 具有乾燥基準重量自10至1000公克/平方公尺。 10. 根據申請專利範圍第1或5項之孔隙板片,其中板片 具有依照ASTM D374-79測定之厚度自約0.2至約4 5 米。 11. 根據申請專利範圍第1或5項之孔隙板片,其中板片 材料包括一種水凝膠,選自:聚胺基甲酸酯凝膠、明 膠、果膠、藻膠、葡胺基烯糖凝膠、琉璃醣碳基酸酯 凝膠、古阿膠、黃酸膠,由澱粉衍生物生成之凝膠、 10 羧基甲基纖維素凝膠、羥基乙基纖維素凝膠、羥基丙 基甲基纖維素、聚乙烯氧化物,與其混合物。 12. 根據申請專利範圍第1或5項之孔隙板片,其中水凝 膠層包括一種水凝膠選自由下者藉聚合或共聚合生成 之凝膠:乙烯基醇類、乙烯基酯類、乙烯基醚類與羧 15 基乙烯基單體、甲基(丙烯)酸、乙烯醯胺單體、陰離 經濟部智慧財產局員工消費合作社印製 子乙烯基單體、羥基乙烯基單體、陽離子乙烯基單體 包含胺類或四級基團、離子性丙烯醯胺衍生物、N-烷 基丙烯醯胺、丙烯酸酯之酯類、離子性丙烯酸酯之酯 類衍生物、N-乙烯基吡咯烷酮、醯基醯胺基丙烷磺 20 酸、馬來酸、N,N-二曱基丙烯醯胺、二丙酮丙烯醯胺 或丙烯醯胺嗎啉。 13. 根據申請專利範圍第1或5項之孔隙板片,其中水凝 膠係化學地或物理地交聯。 14. 一種傷口敷料,其包括一種根據申請專利範圍第1至 -17 - 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 8 8 8 8 A B c D 經濟部智慧財產局員工消費合作社印製 589337 六、申請專利範圍 13項中任一項之孔隙板片。 15. 根據申請專利範圍第14項之傷口敷料,另外包括一與 孔隙板片之背面接觸之吸收層。 16. 根據申請專利範圍第14或15項之傷口敷料,其中吸 5 收層包括一親水性發泡塑料層。 17. 根據申請專利範圍第14或15項之傷口敷料,其中敷 料另外包括一覆蓋孔隙板片之支持層。 18. 根據申請專利範圍第17項之傷口敷料,其中支持層實 質上具液體可滲透性。 10 19.根據申請專利範圍第14或15項之傷口敷料,另外包 括於支持層表面、面對孔隙板片之黏著層。 20.根據申請專利範圍第5項之孔隙板片,其中支持層至 少延伸至孔隙板片之一邊外,以於緊鄰前述一邊處提 供塗覆黏著劑之邊緣,藉之將敷料黏著至一表面。 15 21.根據申請專利範圍第14或15項之傷口敷料,其係無 菌並且包裝於一微生物無法滲透之容器中。 22. —種根據申請專利範圍第1至13項中任一項之孔隙板 片之製造方法,包括步驟: 提供一種孔隙基質之板片; 20 將一種水溶性水凝膠前驅物塗覆於孔隙基H ; 將基質上之水溶性水凝膠前驅物熟化,以於基質 板片上生成孔隙的水凝膠層;與 將孔隙的水凝膠層自基質板片分離。 23. 根據申請專利範圍第22項之方法,其中水溶性水凝膠 -18 - 本紙張尺度適用中國國家標準(CNS)A4規格(210x297公釐)ROC Patent Appln. No. 91116522 No. 91116522 Amended Claims in Chinese-Enci. (T) 5-Amended Claims in Chinese-Enci. (T) 5 (Submitted on August) ιζ 2003) 1. A self-supporting pore plate mainly includes a hydrogel composition with water swell, wherein the pore area is 0.1 / 10 of the area before the plate swell. 10 to 50%. 2. The pore plate according to item 1 of the scope of patent application, which has 1 to 30 pores per square centimeter. 3. The pore plate according to item 1 or 2 of the scope of patent application, wherein the average area of each pore is from 0.001 to 4 square millimeters. 15 4. The porous sheet according to item 1 or 2 of the scope of patent application, wherein the pores have a length to width ratio from 1 to 10 before inflation. 5. The porous sheet according to item 1 of the scope of patent application, wherein the pore area is increased by at least 50% by immersing the sheet in water at 25 ° C for 60 minutes. 20 6. The porous sheet according to item 1 or 5 of the scope of the patent application, in which the swelling hydrogel composition is printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Bubbling Economy, and the slender sheet with a width of 2.5 cm has a tensile strength of 2 to 5 Newton. 7. The pore plate according to item 1 or 5 of the scope of patent application, wherein the pores gradually become smaller from the front surface to the rear surface of the plate. -25 8 · According to the pore plate of item 1 or 5 of the scope of the patent application, where the plate is immersed in water at 25 ° C for 60 minutes, based on the weight of the plate before immersion, the plate absorbs 50 weight / weight% to 1 〇〇wt / wt% water. -16-This paper size applies Chinese National Standard (CNS) A4 specification (210x297 mm) 91330B-connected 589337 A8 B8 C8 _D8_ VI. Application scope of patent 9. According to the application of the patent application scope 1 or 5 of the porous sheet, The plates have a dry basis weight from 10 to 1000 g / m². 10. The porous sheet according to item 1 or 5 of the scope of the patent application, wherein the sheet has a thickness from about 0.2 to about 45 meters as measured in accordance with ASTM D374-79. 11. The porous plate according to item 1 or 5 of the scope of patent application, wherein the plate material includes a hydrogel selected from the group consisting of polyurethane gel, gelatin, pectin, algin, and glucosamine Sugar gels, glaucose carbonate gels, guar gum, xanthan gum, gels derived from starch derivatives, 10 carboxymethyl cellulose gel, hydroxyethyl cellulose gel, hydroxypropyl methyl ester Cellulose, polyethylene oxide, and mixtures thereof. 12. The porous sheet according to item 1 or 5 of the scope of patent application, wherein the hydrogel layer includes a hydrogel selected from gels formed by polymerization or copolymerization of the following: vinyl alcohols, vinyl esters, Vinyl ethers and carboxy 15-based vinyl monomers, meth (acrylic) acid, vinylamine monomers, printed vinyl monomers, hydroxy vinyl monomers, employee cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs Cationic vinyl monomers include amines or quaternary groups, ionic acrylamide derivatives, N-alkyl acrylamide, esters of acrylates, ester derivatives of ionic acrylates, N-vinyl Pyrrolidone, fluorenilinopropylpropanesulfonic acid, maleic acid, N, N-difluorenylacrylamide, diacetoneacrylamide or acrylamide morpholine. 13. The porous sheet according to item 1 or 5 of the application, wherein the hydrogel is chemically or physically crosslinked. 14. A wound dressing comprising a paper according to the scope of patent application Nos. 1 to -17-this paper size applies Chinese National Standard (CNS) A4 specifications (210 X 297 mm) 8 8 8 8 AB c D Intellectual Property Bureau of the Ministry of Economic Affairs Printed by the Employee Consumer Cooperative 589337 VI. Porous sheet of any of the 13 patent applications. 15. The wound dressing according to item 14 of the application, further comprising an absorbent layer in contact with the back surface of the apertured sheet. 16. The wound dressing according to claim 14 or 15, wherein the absorbent layer includes a hydrophilic foamed plastic layer. 17. The wound dressing according to item 14 or 15 of the patent application scope, wherein the dressing further comprises a support layer covering the porous sheet. 18. The wound dressing according to claim 17 in which the support layer is substantially liquid permeable. 10 19. The wound dressing according to item 14 or 15 of the scope of patent application, further comprising an adhesive layer on the surface of the support layer and facing the porous sheet. 20. The porous sheet according to item 5 of the patent application, wherein the support layer extends at least beyond one edge of the porous sheet to provide an edge for applying an adhesive immediately adjacent to the aforementioned side, thereby adhering the dressing to a surface. 15 21. The wound dressing according to item 14 or 15 of the scope of patent application, which is sterile and packaged in a container impermeable to microorganisms. 22. —A method for manufacturing a porous sheet according to any one of claims 1 to 13 of the scope of patent application, comprising the steps of: providing a sheet of a porous matrix; 20 applying a water-soluble hydrogel precursor to the porous sheet Base H; ripening the water-soluble hydrogel precursor on the substrate to form a porous hydrogel layer on the substrate plate; and separating the porous hydrogel layer from the substrate plate. 23. The method according to item 22 of the scope of patent application, in which water-soluble hydrogel -18-This paper size is applicable to China National Standard (CNS) A4 (210x297 mm) 589337 8 8 8 8 A B c D 經濟部智慧財產局員工消費合作社印製 六、申請專利範圍 前驅物之塗覆層,係藉施加氣體壓差於跨越塗覆之基 質予以穿孔。 -19 - 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐)589337 8 8 8 8 A B c D Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 6. Scope of patent application The coating of the precursor is perforated by applying a gas pressure difference across the coated substrate. -19-This paper size applies to China National Standard (CNS) A4 (210 X 297 mm)
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