CN1303303A - 创伤敷料 - Google Patents
创伤敷料 Download PDFInfo
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- CN1303303A CN1303303A CN99806726A CN99806726A CN1303303A CN 1303303 A CN1303303 A CN 1303303A CN 99806726 A CN99806726 A CN 99806726A CN 99806726 A CN99806726 A CN 99806726A CN 1303303 A CN1303303 A CN 1303303A
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- 229920001971 elastomer Polymers 0.000 claims abstract description 31
- 239000000806 elastomer Substances 0.000 claims abstract description 31
- 239000000463 material Substances 0.000 claims abstract description 25
- 239000000853 adhesive Substances 0.000 claims abstract description 16
- 230000001070 adhesive effect Effects 0.000 claims abstract description 16
- 230000001788 irregular Effects 0.000 claims abstract description 8
- 229920002379 silicone rubber Polymers 0.000 claims description 14
- 239000004033 plastic Substances 0.000 claims description 12
- 229920003023 plastic Polymers 0.000 claims description 12
- 238000003475 lamination Methods 0.000 claims description 6
- 238000010521 absorption reaction Methods 0.000 claims description 2
- 229920006255 plastic film Polymers 0.000 abstract description 4
- 239000002985 plastic film Substances 0.000 abstract description 4
- 210000003491 skin Anatomy 0.000 description 19
- 208000027418 Wounds and injury Diseases 0.000 description 7
- 239000011230 binding agent Substances 0.000 description 6
- 239000003292 glue Substances 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 239000000203 mixture Substances 0.000 description 5
- 238000004659 sterilization and disinfection Methods 0.000 description 5
- 210000004027 cell Anatomy 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 229920001296 polysiloxane Polymers 0.000 description 4
- -1 polysiloxanes Polymers 0.000 description 4
- 210000000736 corneocyte Anatomy 0.000 description 3
- 239000000835 fiber Substances 0.000 description 3
- 241000209094 Oryza Species 0.000 description 2
- 235000007164 Oryza sativa Nutrition 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- 235000009566 rice Nutrition 0.000 description 2
- 238000004513 sizing Methods 0.000 description 2
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- 206010033372 Pain and discomfort Diseases 0.000 description 1
- 229920002367 Polyisobutene Polymers 0.000 description 1
- 239000004820 Pressure-sensitive adhesive Substances 0.000 description 1
- 229920004482 WACKER® Polymers 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000001010 compromised effect Effects 0.000 description 1
- 238000002224 dissection Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000010408 film Substances 0.000 description 1
- 239000006261 foam material Substances 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 239000000017 hydrogel Substances 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000005065 mining Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000037311 normal skin Effects 0.000 description 1
- 239000004814 polyurethane Substances 0.000 description 1
- 229920006264 polyurethane film Polymers 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 230000005070 ripening Effects 0.000 description 1
- 230000037307 sensitive skin Effects 0.000 description 1
- 210000004927 skin cell Anatomy 0.000 description 1
- 206010040882 skin lesion Diseases 0.000 description 1
- 231100000444 skin lesion Toxicity 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
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- 238000001356 surgical procedure Methods 0.000 description 1
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- 150000004992 toluidines Chemical class 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/58—Adhesives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0203—Adhesive bandages or dressings with fluid retention members
- A61F13/0206—Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0203—Adhesive bandages or dressings with fluid retention members
- A61F13/0226—Adhesive bandages or dressings with fluid retention members characterised by the support layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
- A61F13/0256—Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the parametric properties of the adhesive
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- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Dermatology (AREA)
- Hematology (AREA)
- Chemical & Material Sciences (AREA)
- Materials Engineering (AREA)
- Epidemiology (AREA)
- Materials For Medical Uses (AREA)
Abstract
本发明涉及一种创伤敷料,该敷料包括在其一面上涂覆了粘合弹性体(3)的载体层。根据本发明,载体层是由塑料薄膜(1)和表面结构不规则的材料(2)组成的叠层形状。
Description
本发明涉及皮肤用创伤敷料或贴带,它包括在其一面上涂覆有粘合弹性体的载体层。
由透水汽的塑料薄膜制成的薄的粘合性创伤敷料,例如OpSite(英国Smith & Nephew公司)或Tegaderm(美国3M公司),包括丙烯酸型粘合剂或性质类似的粘合剂。这样的粘合剂在重复使用时容易将部分皮肤上层(角质层(the stratumcorneum))与它们一起除掉,敷料的这种性质会造成皮肤损害。这些粘合剂也强烈地粘附着皮肤上的毛发,因而在取下敷料时会引起疼痛和不适。
牌号为Metipel的纱布绷带在本技术领域中也是已知的,它是用非常柔软的粘合聚硅氧烷弹性体(硅弹性体)粘附在皮肤上的。硅弹性体具有皮肤友好粘合性能,比上述的粘合剂对皮肤更柔和得多,在被取下时也不会剥离掉部分角质层。使用这种敷料的人在取掉敷料时不会经历不适或疼痛。硅弹性体的粘合性不因敷料的去除而受损害,因此敷料可以重复使用多次。
因此,如果塑料薄膜敷料用的粘合剂可用粘合特性类似于Metipel用的硅弹性体的粘合弹性体所代替是有益的,特别是在敷料置于敏感皮肤上时。在此有一严重的问题是,发现这种弹性体附着在皮肤上与附着在塑料薄膜上有相同的强度,因而在试图取掉敷料时弹性体层或其大部分有保留在皮肤上的危险。
本发明的目的是要解决这一问题,并提供一种包括一层柔软的粘合弹性体层的功能性薄膜敷料。
这一目的的完成是按本发明用包括在其一面上涂覆有软粘合弹性体的载体层的皮肤用创伤敷料或贴带的方法,其特征在于载体层是一叠层体,由塑料薄膜和表面结构不规则的材料组成。因为柔软的粘合弹性体是通过表面结构不规则的材料附着在塑料薄膜上的,弹性体比不使用表面结构不规则的材料时能更强地固定在薄膜上,因此避免了在除去敷料时弹性体保留在皮肤上的危险。
在一最佳具体实施方案中,表面结构不规则的材料包括非织造材料;软粘合弹性体包括聚硅氧烷弹性体。
本发明将以附图为参考进行比较详细的说明。其中
图1是本发明创伤敷料的一个具体实施方案示意图;
图2是测定柔软度的测试主体的说明。
图1所示的塑料薄膜创伤敷料包括塑料薄膜层1、叠层在塑料薄膜上的非织造材料薄层2和聚硅氧烷弹性体层3。
优选的塑料薄膜是由可透水汽的聚氨酯薄膜组成的,虽然可用其它的塑料薄膜材料。非织造材料层是用热压延的方法或其它适合的方法使其胶合在塑料薄膜上的。弹性体层3是将聚硅氧烷弹性体混合物从上面施于叠层1,2上得到的,非织造层面向上。所说的混合物的量足以完全填充所说非织造材料中的纤维结构,多余的弹性体混合物将会在叠层上面形成光滑平整的表面。施以弹性体混合物层的叠层然后经加热直至弹性体混合物熟化形成弹性体。因为聚硅氧烷弹性体扩展入非织造材料中纤维间的所有自由空间,所以弹性体将有效地固定在叠层上。虽然用图说明的敷料包括三个不同的层,但从上面所说应该得到了解,即硅弹性体扩展通过层2的纤维结构并且向上至塑料薄膜层1。
优选的硅弹性体是德国Wacker Chemie公司制造的名为Silgel 612的零售弹性体。也可以使用其它的软的粘合硅弹性体。虽然因为在创伤治疗中聚硅氧烷的性质好而优选硅弹性体,但也可以使用有皮肤友好性的其它软粘合弹性体,诸如水凝胶或软粘合热熔胶。
如前所述,非织造材料的纤维结构给弹性体提供了有效的固定作用,是优选的固定层。但是其它具有不规则的表面结构的材料,诸如细孔网状材料、松散结构织物材料、开孔低泡材料以及相应的材料,也可给弹性体提供充分有效的固定作用。
在定义上,塑料薄膜的厚度为5-100mm,优选的固定层的单位面积重量为5-100克/米2,优选15-25克/米2,以保证由塑料薄膜和固定层组成的叠层有要求的柔软性。
创伤敷料当然也可以是有孔的,特别是在它包括一重叠的吸收垫时。
敷料也可以用一些常规消毒方法进行消毒,例如b-消毒法、蒸汽消毒法或用环氧乙烷消毒。
用于本文中的“皮肤友好粘合”用于表征适用于本发明的软粘合弹性体呈现的特殊粘合形式。
具有性质比较类似的不同类型的自粘胶常用于不同种类的粘合敷料和外科膏料。这些常用胶的共同特点是,在去除粘合敷料时它们粘附在死的皮肤细胞(角质层)的最外层,其牢固度可使数层这种细胞从皮肤上剥离下来。现今所使用的这类胶料最常用的是丙烯酸类型的胶料,虽然也常用热熔胶和聚异丁烯胶。在皮肤友好胶的情况下,其穿透性(针入度) (构成柔韧度的测定方法)在7-20mm范围,而粘合敷料常用胶的相应值低于3mm。针入度的测定是用基于ASTM D 937和D51580的方法,做了某些修改。所用的仪器是德国Sommer & Runge KG的针入度计PNR10。其测试主体重62.5克,包括重15克的圆锥体并有件号18-0122和重47.5克的圆杆并有件号18-0042。测试主体置于针入度计中垂直于盛有测试材料的圆筒形杯的上方,圆锥体的锥顶与测试材料的表面接触,然后让测试主体自由下落进入圆筒形杯中。5秒钟后测定测试主体穿入测试材料中的程度。圆筒形杯的直径为50mm,高30mm。杯中装填的测试材料高度为25mm。
本发明所用的具有皮肤友好粘合性质的软弹性体比粘合敷料常用胶对皮肤的粘合结合力要弱得多。因此具有皮肤友好粘合性质的弹性体在含这种弹性体的敷料被剥离或揭下时基本上不损害角质层。尽管其粘合结合力较弱,这样的弹性体仍然能有牢固和肯定的粘合性,即敷料自行松动的危险很小,这是由于弹性体的柔软性使其往下流动接触皮肤,并因而提供了较宽的有效接触表面。弹性体的柔软性也使弹性体和其载体在去除敷料时产生大量的能量聚集,其结果对皮肤也产生比较肯定的粘合。
测定剥离效果的实验是以10名志愿受试者进行的,即测定在敷料被揭下后敷料表面被细胞覆盖的程度。使用了4个不同类型的膏料/敷料,它们是Duoderm、OpSite、Leukopore和一用弹性体涂覆(200g/m2)的非织造带。具有皮肤友好粘合性质的软弹性体是聚硅氧烷型的弹性体。将每一产品类型的3个试验样品施用于每一受试者,置于皮肤上24小时。选择性地用甲苯胺对揭掉的敷料表面上存在的角质层细胞进行染色,记录剥离效果。然后测定被细胞覆盖表面的百分数。
结果明显示出下表:
膏料/敷料 | 剥离范围内的敷料数 | ||
<1% | -10% | 311% | |
Duoderm | 0/30 | 0/30 | 30/30 |
OpSite | 0/30 | 0/30 | 30/30 |
Leukopore | 10/30 | 16/30 | 4/30 |
聚硅氧烷贴带 | 27/30 | 3/30 | 0/30 |
要达到“皮肤友好粘合”,在正常皮肤的情况下粘合敷料有最大10%的剥离效果。
因为包括皮肤友好粘合弹性体的敷料在揭下敷料时只带有很有限的角质层细胞数,所以敷料揭下后其弹性体层的表面将是相对无变化的。这就使得这一性质的敷料能够再使用,因为它的粘合性未被损害到任何能察觉得到的程度。能从皮肤上拽下角质层细胞的敷料粘合表面在敷料揭下后基本上被细胞所覆盖,这就意味着这种性质的敷料在重复使用时将无法粘贴在皮肤上。Duoderm、Opsite和Leukopore的粘合性损失为70-100%,而皮肤友好粘合性敷料的粘合性损失小于10%。
为了使粘合敷料或粘合膏料的作用有效,必须使其对皮肤的粘附力超过在正常使用中敷料或膏料受到的负荷。现已发现,在此问题上粘合力一般要求超过0.5N(牛顿) (将25mm宽的贴带在135°的角度从皮肤上剥离或撕下时测定的),因此敷料自行松动的危险不是高得不能接受。优选的粘合力大于0.8N/25mm。
将贴带置于健康的受试者背部并放置24小时测定的Duoderm、OpSite和Leukopore的粘合力分别为1.2N/25mm、2.2N/25mm和0.8N/25mm。剥离试验中所用的聚硅氧烷贴带的皮肤粘合强度为1.5N/25mm。
Claims (5)
1.一种皮肤用创伤敷料或贴带,它包括在其一面上用有皮肤友好粘合性质的粘合弹性体(3)涂覆的载体层,其特征在于载体层(1,2)是包括塑料薄膜(1)和表面结构不规则的材料(2)的叠层。
2.权利要求1所述的创伤敷料,其特征在于表面结构不规则的材料(2)是所谓的非织造材料。
3.权利要求1-2任一项所述的创伤敷料,其特征在于粘合弹性体(3)是聚硅氧烷弹性体。
4.权利要求1-3任一项所述的创伤敷料,其特征在于敷料是穿孔的。
5.权利要求4的创伤敷料,其特征在于所说的敷料包括一吸收垫。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE9801899A SE9801899L (sv) | 1998-05-28 | 1998-05-28 | Sårförband eller fixeringstejp för hud innefattande ett laminat av en plastfilm och ett material med oregelbunden ytstruktur och som är belagt med en klibbig elastomer |
SE98018997 | 1998-05-28 |
Publications (2)
Publication Number | Publication Date |
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CN1303303A true CN1303303A (zh) | 2001-07-11 |
CN1173746C CN1173746C (zh) | 2004-11-03 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB998067261A Expired - Lifetime CN1173746C (zh) | 1998-05-28 | 1999-05-27 | 创伤敷料 |
Country Status (11)
Country | Link |
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US (1) | US6479724B1 (zh) |
EP (1) | EP1082147B1 (zh) |
JP (1) | JP2002516151A (zh) |
CN (1) | CN1173746C (zh) |
CA (1) | CA2332361C (zh) |
DE (1) | DE69919160T2 (zh) |
ES (1) | ES2224678T3 (zh) |
PL (1) | PL192883B1 (zh) |
RU (1) | RU2218138C2 (zh) |
SE (1) | SE9801899L (zh) |
WO (1) | WO1999061077A1 (zh) |
Cited By (1)
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CN111315327A (zh) * | 2017-11-01 | 2020-06-19 | 超龙有限公司 | 一种医用胶带 |
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Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SE0200885L (sv) * | 2002-03-22 | 2003-09-23 | Moelnlycke Health Care Ab | Uppdukningsprodukt med adhesiv kant |
SE0200886L (sv) * | 2002-03-22 | 2003-09-23 | Moelnlycke Health Care Ab | Uppdukningsprodukt med adhesiv kant för kirurgiska ingrepp |
DE10249874A1 (de) | 2002-10-25 | 2004-05-06 | Gesellschaft zur Förderung von Medizin-, Bio- und Umwelttechnologien e.V. | Antiadhäsive Beschichtung zur Ausrüstung von Wundverbänden |
AU2003294367B2 (en) | 2002-12-31 | 2009-11-12 | Bsn Medical Gmbh | Wound dressing |
WO2005021058A2 (en) * | 2003-09-02 | 2005-03-10 | Coloplast A/S | Adhesive composition comprising hydrophilic and hydrophobic silicone elastomers |
CN1852691B (zh) | 2003-09-17 | 2012-01-11 | Bsn医疗有限责任公司 | 伤口敷料及其生产方法 |
US7531711B2 (en) | 2003-09-17 | 2009-05-12 | Ossur Hf | Wound dressing and method for manufacturing the same |
US7249385B2 (en) * | 2004-01-20 | 2007-07-31 | Richard Schukraft | Finger/toe tip protective apparatus |
SE0500061L (sv) | 2005-01-11 | 2006-07-12 | Moelnlycke Health Care Ab | Tätande filmförband |
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-
1998
- 1998-05-28 SE SE9801899A patent/SE9801899L/xx not_active IP Right Cessation
-
1999
- 1999-05-27 RU RU2000133217/14A patent/RU2218138C2/ru active
- 1999-05-27 US US09/701,359 patent/US6479724B1/en not_active Expired - Lifetime
- 1999-05-27 JP JP2000550536A patent/JP2002516151A/ja active Pending
- 1999-05-27 ES ES99930029T patent/ES2224678T3/es not_active Expired - Lifetime
- 1999-05-27 CN CNB998067261A patent/CN1173746C/zh not_active Expired - Lifetime
- 1999-05-27 CA CA2332361A patent/CA2332361C/en not_active Expired - Lifetime
- 1999-05-27 WO PCT/SE1999/000903 patent/WO1999061077A1/en active IP Right Grant
- 1999-05-27 DE DE69919160T patent/DE69919160T2/de not_active Expired - Lifetime
- 1999-05-27 PL PL344442A patent/PL192883B1/pl unknown
- 1999-05-27 EP EP99930029A patent/EP1082147B1/en not_active Expired - Lifetime
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN111315327A (zh) * | 2017-11-01 | 2020-06-19 | 超龙有限公司 | 一种医用胶带 |
Also Published As
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---|---|
JP2002516151A (ja) | 2002-06-04 |
DE69919160D1 (de) | 2004-09-09 |
CA2332361C (en) | 2010-08-24 |
PL344442A1 (en) | 2001-11-05 |
EP1082147A1 (en) | 2001-03-14 |
US6479724B1 (en) | 2002-11-12 |
PL192883B1 (pl) | 2006-12-29 |
ES2224678T3 (es) | 2005-03-01 |
CN1173746C (zh) | 2004-11-03 |
SE510907C2 (sv) | 1999-07-05 |
CA2332361A1 (en) | 1999-12-02 |
SE9801899D0 (sv) | 1998-05-28 |
DE69919160T2 (de) | 2004-12-30 |
WO1999061077A1 (en) | 1999-12-02 |
EP1082147B1 (en) | 2004-08-04 |
RU2218138C2 (ru) | 2003-12-10 |
SE9801899L (sv) | 1999-07-05 |
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