CN1139876A - 衬垫 - Google Patents
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Abstract
本申请描述了一种衬垫材料,它包括第一层可透湿汽薄膜层和第二层可透湿汽薄膜层,在两层薄膜之间分布有多个气泡。气泡内可任选用泡沫装填。本申请还描述了衬垫材料的制造方法和用途。
Description
本发明涉及一种新式衬垫及其制造方法,该衬垫可用作例如骨折修复用的刚性铸模的内衬,或用作减压包扎用品。
放在矫形铸模下面的衬垫材料通常包括柔软的适应性材料,如天然的或合成的非编织材料,例如英国Smith & NephewMedical公司出售的叫作Soffban那样的材料。
但是,这样材料碍于以下缺点,它们通常不适合与水淬硬化的树脂矫形铸模一起使用。况且,这样的树脂铸模一旦成形,它就可以接触水而不发生任何变质,因此可给患者带来过正常生活的诸多自由。但由于内衬衬垫吸水并因接触水而会损坏其结构,这就会限制患者的自由。另外,若使用传统的防水材料而长时间置于患处就可能使皮肤浸软。
虽然减压包扎用品并不要求防水,但这种包扎用品如长时间置于患处仍可能使皮肤浸软。在下文中,矫形铸模衬垫材料和减压包扎用品将统称为衬垫材料。
美国专利5102711描述了一种充填有可透气泡沫的衬垫材料,它包括中间的泡沫层和涂浸过亲水聚氨酯层的上下聚四氟乙烯(PTFE)保护层。用熔焊法把两面的聚四氟乙烯保护层周边粘接起来做成一个“填絮的粘合体”。
但是,这样的材料也碍于很多缺点:它们的制造成本很高,没有足够的适应性,而且在极高和极低压力下,填充的泡沫层可能塌陷。
现在我们已经令人惊喜地发现了一种衬垫材料,它可克服或减轻这些缺点。
本发明提供的衬垫材料包括:第一层可透湿汽的薄膜层和第二层可透湿汽的薄膜层,在两薄膜层之间分布着多个气泡。
两薄膜层之间的气泡可以凸出在一层上,或者也可以在两层上都凸出。
可透湿汽的薄膜层可采用一层粘附层把第一和第二薄膜层中的一层或二层粘结在一起。替代的办法是,两层薄膜可以熔焊在一起。
气泡可以是任何传统的外形,例如方形、圆形、五角形、六角形等。优选的气泡外形应是在包扎用品使用过程中比较不易被撞破的。如果一种气泡形状(如方形)具有后来居上者的话,那么,这优选的后来居上者就是圆形。
气泡的直径可以从0.5到2.0cm,优选的是1cm。气泡的厚度可以从1到10mm,优选的是3到6mm,最优选的是4到5mm,气泡最好是相互间隔开,以使具有不存在空气的空白区。这样可使气泡与近邻之间相隔两倍于它的直径的距离(从气泡中心量起),例如1cm直径的气泡与其近邻的中心间距能有2cm。
除粘接在一起的薄膜层以外,本发明的衬垫材料中一层或两层薄膜层上可以涂上一层粘附层,例如在薄膜层的非面对薄膜的表面涂上一层对压力灵敏的粘附层。薄膜层和粘附层最好都是透明或半透明的。粘附层可以涂满薄膜层的整个一面或者只涂一部分,例如涂周边一圈。包扎用品也可以不带粘附层。
在衬垫材料中使用的可透湿汽薄膜最好包括一层薄而柔软的膜,以使衬垫材料变得具有高度的适应性。
在本发明的衬垫材料中适用的可透湿汽的薄膜层,可以是在传统的伤口包扎粘附带上用的任一种薄的、有适应性的可透湿汽薄膜层。本发明的衬垫材料优选的组成材料是弹性的。
可透湿汽的薄膜层可以适当地选用传统上用来制造薄的外科包扎用品的材料中的任何一种。适用的材料包括那些英国专利1280631、欧洲专利51935、91800和178740中所描述的。
受到青睐的可透湿汽薄膜包括用聚醚聚氨酯、聚酯聚氨酯、亲水聚氨酯和聚酯-聚醚共聚物制造的薄膜。
美国专利2899411描述了数种适用的聚醚聚氨酯。美国专利2871218描述了数种适用的聚酯聚氨酯。已知的适用聚酯和聚醚聚氨酯为ESTANE牌的,可从BF Goodrich公司购得,特别是5701、5702、5703、5714F和580201几种等级的最适用。
其它备受青睐的材料包括亲水共聚物如亲水聚氨酯,其中包括英国专利2093190B所描述的那些,特别是它里面的例2所描述的那种聚氨酯。
其它适用的材料有弹性聚醚聚酯,例如已知的HYTREL牌的,还有弹性聚酯酰胺,例如已知的PEBAX牌的。
有一种聚酯-聚醚共聚物是已知的HYTREL 4056牌的,可从杜邦公司购得。
可透湿汽薄膜的厚度可以是从9到100μm,9到80μm也合适。背层厚度更合适的是15到50μm,优选的是20到40μm,例如27.5、30μm,35μm。
为了提供优良的衬垫效果,可在汽泡中放入泡沫。因此,按以本发明,我们提供了一种衬垫材料,它包括第一层可透湿汽薄膜层和第二层可透湿汽薄膜层,以及夹在第一和第二薄膜层之间的多个泡沫粒。
泡沫粒可以包括封闭在每个气泡中的多个泡沫颗粒。但是,优选的是一个气泡包含一个单独的泡沫岛。
在本发明的衬垫材料中可透湿汽薄膜最好是不透水的。但是,当要求把不防水的衬垫材料,例如用作减压包扎用品,而且当具有泡沫粒时,则至少有一层薄膜层不需要连续。
因此,按照本发明,我们提供了一种衬垫材料,它包括一层不透水而可透湿汽的薄膜层,一层可透水和湿汽的薄膜层,以及夹在两薄膜层之间的多个泡沫粒。
不透水薄膜层和透水薄膜层可以任选地包括一层中间粘附层。粘附层可以涂在泡沫粒的面对薄膜表面的一面或两面。
不透水薄膜层可包括一层多孔膜。优选的多孔膜是网状膜。在本发明的衬垫材料中使用的多孔膜或网膜的空隙面积,至少占薄膜面积的25%为合适,赞赏至少有30%,而优选的是至少有35%。类似地,多孔膜的空隙面积以不大于薄膜面积的90%为合适,赞赏不大于70%,优选的是不大于60%。
本发明的衬垫材料用的多孔膜或网膜上的孔隙大小,至少有0.7mm为合适,优选的是至少有0.8mm。类似地,孔隙大小以不大于2mm为合适,而优选的是不大于1.5mm。孔隙可以是对称的形状,如方形、长方形、圆形、椭圆形、菱形、三角形,或者是不对称的形状。
可以用任何传统的穿孔方法来做成孔隙。穿孔方法包括用针或穿孔器的机械方法;用例如加热的突起物如加热针或浮雕滚子或热流体如火焰或灼热气体对选定面积的热熔穿孔法;以及拉伸法,把浮雕出较薄区域的薄膜或薄板拉伸成网。
本发明使用的网膜优选的是柔软的聚合物网膜。聚合物网膜在这里是作为多孔的聚合物薄板使用的,网孔是由整体的铰合线和接合点围成的。这样的网膜可用拉伸浮雕出较薄区域的薄膜或薄片来制作。
受到青睐的聚合物网膜包括一种弹性聚合物,特别是一种热塑性弹性体聚合物。这样的弹性聚合物网膜能使本发明的矫形衬垫材料的表面产生“柔和感”。
适用的热塑性弹性聚合物包括聚醚酯和聚醚-聚酰胺嵌段共聚物、聚氨酯、苯乙烯一丁二烯和苯乙烯-异戊二烯嵌段共聚物、聚异丁二烯和乙烯-乙烯基乙酸酯共聚物。
用于本发明的网层可以包括弹性聚合物,如乙烯-乙烯基乙酸酯共聚物与相容的聚合物的混合物,或与不相容的聚合物,如聚烯烃例如低密度的聚乙烯或聚苯乙烯的混合物。
本发明与US5102711的现有技术之间的重要区别是,薄膜与网层是互相接触的,以使泡沫层不连续,这样可使材料更透气并更有适应性,这是需要特别指出的。
任何传统的泡沫都可用于制作本发明的衬垫材料中的泡沫粒。泡沫不必是具有吸收渗出液的性能的,虽然这种泡沫也包括在本发明的范围之内。但是优选的泡沫是非吸收性的。
当泡沫粒是泡沫岛时,泡沫岛可以是任何传统的形状,例如方形、圆形、五角形、六角形、菱形等。本发明特别有利的情况是提供一种泡沫岛,这种泡沫岛当衬垫材料缠绕在肢体上时可以互相联锁起来。这会使得衬垫材料在能提供适宜的衬垫效果的同时,还能提供必需的适应性和使用较少的材料。
因此,按照本发明,我们提供了以上描述的一种衬垫材料,其中当铸模内衬衬垫缠绕到患者肢体上时,泡沫岛基本上可与邻近的泡沫岛联锁起来。
泡沫岛的尺寸可以各种各样,但优选的尺寸是0.2到2.0cm宽,最好是1cm宽,宽度并不限于这些数值。泡沫岛的厚度可以是从1到10mm,优选是3到6mm,最优选的是4到5mm。泡沫岛最好相互隔开,以使保有无泡沫存在的区域。因此泡沫岛可以间隔成与近邻之间有两倍其宽度的距离。例如1cm宽的泡沫岛与近邻的间隔可以有中心间距离2cm。
本发明的衬垫材料所用的粘附层,可以是涂敷传统的伤口包扎用品的任何对压力灵敏的粘附层。粘附层可以作为两薄膜层之间的中间层或者作为衬垫材料中在非面对薄膜表面上的涂层。
对压力灵敏的粘附层用传统上用于与皮肤接触的粘附剂来配制是适当的。英国专利1280631和欧洲专利35399和51935所描述的粘附剂是合适的。优选的粘附剂是聚乙烯乙醚粘附剂或丙烯酸酯共聚物粘附剂,它们是由丙烯酸2-乙基己基酯、丙烯酸丁基酯和丙烯酸共聚合而生成的。
受到青睐的这类粘附剂是聚乙烯醚粘附剂和丙烯酸粘附剂。英国专利2070631公开了一种适用的丙烯酸粘附剂,它含有47重量份的丙烯酸丁酯,47重量份的丙烯酸2-乙基己基酯和6重量份的丙烯酸的共聚物。
粘附层可以涂成连续的,也可以是不连续的。粘附层可以是多孔的、微孔的或无孔而能透气的。这样的粘附涂层的单位面积涂敷重量通常为10到75g/m2,更常见的是15到65g/m2,优选的单位面积重量为20到40g/m2。按厚度来说,粘附层可以是从15到65μm厚,优选的是从20到40μm厚。
本发明的衬垫材料可以这样制备:用聚合物溶液浇铸成薄膜,该聚合物是用来制造不透水而可透湿汽的薄膜层用的。再在薄膜上涂上粘附剂,放置多个泡沫岛,然后在粘附层上层压第二层薄膜层或网。
按照本发明,我们在上文的描述中提供了衬垫材料的制造方法,它包括:
(i)在支持层上浇铸一层可透湿汽薄膜;
(ii)在可透湿汽薄膜上涂一层粘附剂;
(iii)在粘附层上放置多个泡沫粒;
(iv)在粘附层上放置第二层薄膜;
(v)把第一层薄膜与第二层薄膜层压在一起。
不带泡沫粒而含有气泡的衬垫材料可用下法制造:
(i)在支持层上浇铸第一层可透湿汽薄膜,该支持层也可以是涂过粘附剂的;
(ii)在外加热量或真空的多孔载体层上浇铸第二层可透湿汽薄膜;以及
(iii)把第一层和第二层可透湿汽薄膜层压在一起。
衬垫材料可放入防菌包中,密封起来并按传统方法消毒灭菌,包括使用环氧乙烷或伽玛射线照射。
不透水但可透湿汽的薄膜在37℃和100%相对湿度差之下,至少具有湿汽传导率500g/m2/24h是合适的,更适合的是至少有1200g/m2/24h,优选的是至少有1600g/m2/24h,例如达到9000g/m2/24h,而最优选的是从2000到3000g/m2/24h。但是,多孔薄膜的湿汽传导率可比上述数值高出很多。
矫形衬垫材料的湿汽传导率可很容易地用欧洲专利46071所描述的Payne Cup法(在竖直位置下)来确定。
按照本发明,我们提供了处理身体某部分骨折的方法,它包括缠贴一层本发明的铸模内衬衬垫材料,然后应用可硬化的铸模材料。
本方法的特别优越之处在于,铸模材料是水淬硬化的材料,例如是树脂,身体的某个部位包扎了这种衬垫材料和铸模材料后可以浸入水中。因此说,象前面所描述的那样,我们提供了一种可使身体的某一部分浸入水中的处理方法。
本发明还进一步提供一套配套用品,它包括上文描述的衬垫材料以及一种矫形铸模带,例如涂有树脂的铸模带,比如涂有水淬硬化树脂的铸模带。
现在,本发明将参考附图来加以描述,但决不局限于这些附图。
图1是一种衬垫材料的断面图,其中气泡是由一层可透湿汽薄膜上的凹坑来形成的;
图2是一种衬垫材料的断面图,其中气泡是由两层可透湿汽薄膜上的凹坑来形成的;
图3是一种衬垫材料的断面图,其中有泡沫粒夹在两层可透湿汽薄膜之间;
图4是一种衬垫材料的断面图,其中有泡沫岛夹在两层可透湿汽薄膜之间;
图5简单表示出一位患者的上肢缠有本发明的衬垫材料;以及
图6至10简单示出包扎用品的各种泡沫岛种形状图。
在图1中,衬垫材料(1)中包括第一层可透湿汽薄膜层(2),第二层可透湿汽薄膜层(3)和粘附层(4)。第一层薄膜层(2)包括有许多凹坑(5),这些凹坑围绕着气泡(6)。
在图2中,第一层和第二层可透湿汽薄膜层(2)和(3)包括有对应的凹坑(5和7),这些对应凹坑围绕着气泡(6)。
在图3中,衬垫材料(1)包括第一层可透湿汽薄膜层(2)、第二层可透湿汽薄膜层(3)和粘附层(4)。夹在两薄膜层(2和3)之间的是泡沫岛(8)。
在图4中,衬垫材料(1)包括第一层可透湿汽薄膜层(2),第二层可透湿汽薄膜层(3),例如一层网,以及粘附层(4)。夹在两薄膜层(2和3)之间的是泡沫岛(8),该泡沫岛可任选涂上一层粘附层(9)。
在图5中,材料(1)被用作衬垫绕在患者手臂上,绕法是使泡沫岛相互联锁起来以发挥衬垫效果。
现在,本发明将用下列实例来加以说明,但决不局限于这些实例。
实例1
铸模内衬衬垫的制造
铸模内衬衬垫是作为下列构成部分的复合物来制造的:
a)聚氨酯薄膜
b)粘附剂
c)衬垫
d)网
1.制造聚氨酯薄膜时,是利用众所周知的刮刀/滚子技术,在有脱模涂层的纸上浇注聚氨酯溶液(estane/四氢呋喃),加以干燥并做成包装卷作为一批产品。薄膜控制在20-30gm-2。
2.利用刮刀/滚子技术,将以溶剂为载体的对压力灵敏的丙烯酸粘附剂,涂在有脱模涂层的纸上,重量为20gm-2。在干燥后,将此压合到聚氨酯薄膜上,同时从薄膜上除去脱模纸,留下聚氨酯薄膜/粘附层/脱模纸的层压薄片。包装卷则在“卷压纵切机”上切割成适当的宽度。
3.泡沫是Alveo公司提供的3mm厚的聚氨酯泡沫。利用模子和冲床切割成要求尺寸的形状。
4.所用的网为27gm-2的聚乙烯网,参考号为12×27,是由Smith & Nephew Extruded Films公司提供的,切割成80mm宽。
样品是这样制作的:
a)把聚氨酯/粘附层/纸的层压薄片(2.7m×80mm)将纸的一面朝上铺平在一个清洁的平面上,揭开纸,让粘附层暴露出来。
b)放置成形的泡沫垫,相距25mm。
c)在泡沫垫和粘附层上放上聚乙烯网。用一个滚子来使网膜与粘附层贴紧。最后把做好的复合体卷起来。
总共制作了6种式样的衬垫,见图6-10。
Claims (11)
1.一种衬垫材料,它包括第一层可透湿汽的薄膜层和第二层可透湿汽的薄膜层,其中在第一和第二薄膜层之间分布有多个气泡。
2.权利要求1的衬垫材料,其中气泡的直径为0.5至2.0cm。
3.权利要求1的衬垫材料,其中气泡的厚度为1至10mm。
4.一种衬垫材料,它包括第一层可透湿汽薄膜层和第二层可透湿汽薄膜层,并在第一和第二薄膜层之间夹入了多个泡沫粒。
5.一种衬垫材料,它包括一层不透水但能透湿汽的薄膜层,一层多孔的可透湿汽的薄膜层和一层中间粘附层,并有多个泡沫岛夹在多孔薄膜层和粘附层之间。
6.权利要求5的衬垫材料,其中多孔薄膜为网。
7.权利要求5或6的衬垫材料,其中泡沫是疏水的。
8.权利要求5或6的衬垫材料,其中当衬垫缠绕在患者肢体上时,泡沫岛可以基本上与邻接的泡沫岛联锁起来。
9.制造上述衬垫材料的方法,它包括:
(i)在支持层上浇铸一层可透湿汽的薄膜;
(ii)在该可透湿汽薄膜上涂上粘附剂;
(iii)在该粘附层上放置多个泡沫岛;
(iv)在该粘附层上放置第二层薄膜;以及
(v)把第一层和第二层薄膜层压合在一起。
10.处理身体某部分骨折的方法,它包括缠贴一层本发明的铸模内衬衬垫材料,接着使用可硬化的铸模材料。
11.一套配套用品,它包括上述的衬垫材料以及一种矫形铸模带,例如涂有树脂的铸模带,比如涂有水淬硬化树脂的铸模带。
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-
1994
- 1994-11-03 CA CA002175662A patent/CA2175662A1/en not_active Abandoned
- 1994-11-03 CN CN94194705A patent/CN1139876A/zh active Pending
- 1994-11-03 EP EP95900196A patent/EP0726750A1/en not_active Withdrawn
- 1994-11-03 AU AU81102/94A patent/AU696714B2/en not_active Ceased
- 1994-11-03 US US08/635,901 patent/US5720714A/en not_active Expired - Fee Related
- 1994-11-03 WO PCT/GB1994/002410 patent/WO1995012373A1/en not_active Application Discontinuation
- 1994-11-03 JP JP7513091A patent/JPH09505492A/ja active Pending
- 1994-11-03 GB GB9609141A patent/GB2298162A/en not_active Withdrawn
Cited By (3)
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---|---|---|---|---|
CN101309658B (zh) * | 2005-09-22 | 2012-06-06 | 途安公司 | 治疗皮肤和皮下组织感染及运动恢复用的装置、绷带和服饰品及其制造方法 |
US10409709B2 (en) | 2015-09-25 | 2019-09-10 | Huawei Technologies Co., Ltd. | Debugging method, multi-core processor and debugging device |
CN106626590A (zh) * | 2016-12-07 | 2017-05-10 | 滁州瑞林包装材料有限公司 | 一种抗压抑菌的药品包装用复合膜 |
Also Published As
Publication number | Publication date |
---|---|
GB2298162A (en) | 1996-08-28 |
JPH09505492A (ja) | 1997-06-03 |
US5720714A (en) | 1998-02-24 |
AU696714B2 (en) | 1998-09-17 |
EP0726750A1 (en) | 1996-08-21 |
AU8110294A (en) | 1995-05-23 |
CA2175662A1 (en) | 1995-05-11 |
GB9609141D0 (en) | 1996-07-03 |
WO1995012373A1 (en) | 1995-05-11 |
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