CN1426292A - 新型创伤敷料、制造过程及其有用的制品 - Google Patents
新型创伤敷料、制造过程及其有用的制品 Download PDFInfo
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Abstract
本发明涉及一种具有独特两用性的创伤敷料。敷料的一个表面包括聚氨酯泡沫(20),另一表面包括非粘合性的薄膜(30),薄膜是聚二甲基硅氧烷和聚四氟乙烯相互穿插的聚合物网(“IPN”)。当敷料的泡沫侧向下对着创伤时,制品提供粘合性表面,应用于难以固定的条件下。当敷料的IPN侧对着创伤时,敷料提供非粘合性的覆盖,应用于脆弱的和敏感的创伤。
Description
发明领域
本发明涉及一种新型创伤敷料设计。具体地,本发明涉及一种创伤敷料,它具有两个不同的层,每层具有有用的特征,两层合在一起提供一种新型的处理多种创伤类型的方法。使用更简单,病人更舒服,护理成本更低。
现有技术
在创伤护理领域有几种一般类型的常用敷料。有些敷料非常紧地粘附在创伤表面。例如,当出现愈合并且创伤表面结痂时传统的纱布与创伤结合在一起。其它类型的敷料设计是粘附在创伤位置周围的完好的组织上,但不与创伤直接接触。这种类型的敷料包括涂有压敏粘合剂的聚氨酯薄膜。其它类型的敷料设计完全是非粘合性的。这种类型的例子包括聚环氧乙烷水凝胶,特别是美国专利4,832,009中描述的材料。后者是由聚四氟乙烯和硅酮相互穿插的聚合物网络(“IPN”)制成的,目前由宾夕法尼亚州Allentown的Bio Med Sciences公司销售,名称为Silon-TSR临时皮肤置换物。每种类型的敷料具有优点和缺点,应用于特定的创伤条件和使用者的偏好。
创伤类型的范围很广,创伤可分类成慢性的和急性的。慢性创伤的例子包括静脉郁积溃疡、褥疮溃疡和糖尿病溃疡。急性创伤的例子包括烧伤、皮肤移植的取皮点、皮肤移植的植皮点、擦伤等等。根据创伤类型以及创伤在身体上的部位确定所需恰当性能创伤敷料的特征。例如,非粘合的薄膜将敷料更换过程中脆弱皮肤的损伤减小到最低程度,但不能总是使用这种敷料,因为难以将敷料固定在恰当位置上。对于皮肤移植取皮点在病人背部或臀部来说这特别是一个挑战,因为普通的运动和与被褥的接触也能容易地使敷料移位。结果,对于这种类型的创伤通常使用粘合剂敷料。另外一个例子包括在慢性创伤上使用吸收性敷料。慢性创伤容易产生很多渗出物,难以使用薄膜敷料,因为这些敷料在处理创伤流体方面一般较差。
即使是同一个创伤,在愈合过程的不同阶段需要不同的敷料。静脉溃疡在愈合早期产生大量渗出物。对于这些创伤常常使用水胶体,因为它们有高的吸收能力。但当这种类型的创伤愈合时,在更换敷料时脆弱的上皮容易受损,因此在愈合过程的后期也替换为非粘合性敷料,即使它不具有吸收性。
Bio Med Sciences公司生产的薄膜非粘合性敷料是由聚四氟乙烯和硅酮(Silon-TSR)相互穿插的聚合物网(“IPN”)制成的。IPN膜是柔性的并且薄(50微米),从而是透明的并与创伤的形状很好地吻合。在薄膜上开一小孔,使创伤流体从创伤表面流出并被第二敷料如纱布吸收。根据需要可以更换外层纱布,但IPN敷料将留在原处,直到创伤愈合或达到10天。
IPN敷料非常适合应用于激光表面修复,它是几乎完全在面部进行的美容手术。这种产品的非粘合性以及透明性在愈合过程中具有临床优势,但是,这种产品不能应用于某些类型的创伤,例如皮肤移植的取皮点和很多其它类型的慢性创伤。这种产品的非粘合性在应用于身体上任何受到剪切力的部位时也有问题,例如与被褥或其它表面接触时,将导致敷料从创伤上卷曲或滑脱。应用于靠下的肢体难度更加突出,因为这些部位的形状有些圆锥形,从而导致敷料向末端滑脱。
Bio Med Sciences公司生产的IPN敷料在考虑使用舒服的非粘合性表面覆盖创伤时提供了所需的性能。但是,在考虑保持创伤的覆盖和避免敷料卷曲和滑脱时,被证明是有问题的。
发明概述
为了减少以上有问题的特征,本发明出乎意料地创造了一种具有独特两用设计的敷料。
这种新型敷料包括一薄层(50微米)的IPN材料与一层厚度约1500微米的聚氨酯泡沫层叠在一起。这种结构的效果是提供了较大的断面厚度,从而能更有效地抵抗卷曲、折皱和滑脱。
将敷料应用到创伤处,使IPN表面对着创伤表面,保留了IPN材料的非粘合优点。但是,同时泡沫层将敷料卷曲、折皱和滑脱的倾向减小到最低程度。在IPN材料中仍切出小孔,泡沫将创伤渗出物传递到第二敷料。
出乎意料地,本发明发现当反转敷料使泡沫层而不是IPN层对着创伤时,本发明的敷料对创伤的护理仍是有用的。这可用于提供除了其它相似特征外还具有高水平表面粘合性的敷料。创伤流体仍可从创伤表面引流到第二敷料,并仍将滑脱或卷曲减小到最低程度。
本发明提供了一种单独的敷料,能根据它在创伤表面的取向产生完全不同的创伤愈合特征。这有益于扩展其临床应用的范围,因为可以分别使用IPN材料或泡沫层。这可以应用于不同的临床案例或同一案例愈合过程的不同阶段。
虽然创伤愈合的这两种相反的方法(粘合/非粘合)在本领域中是常见的,但没有一种产品通过简单将其中一者放在另一者的上面,将这两个特征结合在一种单独的敷料中。这对于将库存产品数量减少到最低程度以降低存货成本来说,将产生很大的便利。另外,由于减少了制造和分送的工作,也提高了成本效率。最重要的是,本发明提供了一种独特的应用于大范围创伤类型的两用敷料。
附图简述
图1表示本发明优选实施例的剖视图。IPN材料10通过硅橡胶30结合在泡沫层20上。
图2表示从本发明材料切下的敷料40的平面图。孔50贯穿PIN膜,提供处理创伤渗出物的方式。
优选实施例
参看附图,图中所示的本发明新型敷料包括一薄层(50微米)IPN材料10,层叠在约1500微米厚的聚氨酯泡沫20上。优选的,使用硅橡胶30将IPN材料10结合到聚氨酯泡沫20上。孔50贯穿PIN膜,提供处理创伤渗出物的方法。
下面的实施例并不具有限制性,因为对这些设计和过程任何小的改变,对于本领域熟知人员都是显而易见的。因此,可以相信,使用其它材料能达到相同的敷料设计。实施例1:
根据已有的方法制造连续的聚二甲基硅氧烷和聚四氟乙烯IPN薄膜。薄膜的厚度约50微米。接着将IPN薄膜通过一个刀在滚筒上形状的装置并涂覆约200微米厚的液体硅橡胶MDX4-4210,它出自于密执安州Midland的Dow Corning公司。硅橡胶涂到IPN上不久后,将开孔的亲水性泡沫(缅因州Boothbay的Rynel有限公司生产的Amrel医用泡沫)放在未硫化的硅橡胶上,将此叠层通过一个隧道式的炉子,在150℃保温6分钟。接着将得到的材料送入一个旋转的模切设备,从薄带上切下单独的敷料,并在IPN膜上形成孔。实施例2:
重复实施例1的过程,但在叠层之前将颜料加入液体硅橡胶中。将蓝色的硅酮基墨水(加利福尼亚州Carpinteria的Nusil技术公司的产品,编号为R1008-7)混入到MDX4-4210中,重量百分比的浓度为4%。由于IPN材料是透明的,泡沫是不透明的,蓝色的颜料将敷料的一侧染成淡蓝色。这可作为一个视觉指示,用于将敷料的一侧与另一侧区分开。
Claims (37)
1.一种创伤敷料,根据它在创伤表面的取向能提供完全不同的创伤处理特征。
2.如权利要求1所述的制品,其特征在于一个取向提供非粘合的表面,另一个取向提供粘合表面。
3.如权利要求1所述的制品,其特征在于创伤敷料包括多层复合结构。
4.如权利要求2所述的制品,其特征在于创伤敷料包括多层复合结构。
5.如权利要求3所述的制品,其特征在于多层复合结构包括至少一层薄膜和一层泡沫。
6.如权利要求4所述的制品,其特征在于多层复合结构包括至少一层薄膜和一层泡沫。
7.如权利要求5所述的制品,其特征在于薄膜层包括含有硅酮的化合物。
8.如权利要求6所述的制品,其特征在于薄膜层包括含有硅酮的化合物。
9.如权利要求5所述的制品,其特征在于泡沫层包括聚氨酯材料。
10.如权利要求6所述的制品,其特征在于泡沫层包括聚氨酯材料。
11.如权利要求5所述的制品,其特征在于薄膜层包括含有硅酮的化合物,并且泡沫层由聚氨酯材料构成。
12.如权利要求6所述的制品,其特征在于薄膜层包括含有硅酮的化合物,并且泡沫层由聚氨酯材料构成。
13.一种制造创伤敷料的方法,所述创伤敷料根据它在创伤表面的取向能提供完全不同的创伤处理特征,所述方法包括:(1)生产聚合物的薄膜;(2)将所述薄膜通过涂层设备并涂覆一层粘合剂;(3)将泡沫材料与所述粘合剂紧密接触;(4)可以选择将此薄带切成单个的敷料和/或在薄膜上形成小孔。
14.一种使用敷料处理不同类型创伤的方法,所述敷料根据它在创伤表面的取向能提供完全不同的创伤处理特征。
15.一种新型的创伤敷料,完全如这里所描述的一样。
16.一种新型的制造两用创伤敷料的方法,完全如这里所描述的一样。
17.一种新型的处理不同类型创伤的方法,完全如这里所描述的一样。
18.一种用作创伤敷料的复合制品,所述制品包括:
第一表面;和
第二表面,
其特征在于所述第一表面和所述第二表面的各自都具有完全不同的创伤治疗性能。
19.一种用作创伤敷料的复合制品,所述制品包括:
至少一层第一层材料;和
至少一层第二层材料,
其特征在于
所述至少一层的第一层材料形成所述制品的第一表面;
所述至少一层的第二层材料形成所述制品的第二表面;和
所述第一表面和所述第二表面各自都具有完全不同的创伤治疗性能。
20.如权利要求19所述的复合制品,还包括将所述至少一层的第一层材料粘合到所述至少一层的第二层材料上的粘合剂。
21.如权利要求20所述的复合制品,其特征在于所述粘合剂包括硅酮化合物。
22.如权利要求19所述的复合制品,其特征在于所述至少一层的第一层包括至少一层薄膜层。
23.如权利要求19所述的复合制品,其特征在于所述至少一层的第一层包括含有硅酮的化合物。
24.如权利要求19所述的复合制品,其特征在于所述至少一层的第二层包括泡沫层。
25.如权利要求24所述的复合制品,其特征在于所述泡沫层包括聚氨酯。
26.如权利要求23所述的复合制品,其特征在于含有硅酮的化合物包括聚四氟乙烯和硅酮的相互穿插的聚合物网。
27.如权利要求24所述的复合制品,其特征在于含有硅酮的化合物包括聚四氟乙烯和硅酮的相互穿插的聚合物网络。
28.如权利要求23所述的复合制品,其特征在于所述泡沫层包括聚氨酯。
29.如权利要求24所述的复合制品,其特征在于所述泡沫层包括聚氨酯。
30.如权利要求19所述的复合制品,还包括添加到所述至少一层的第一层和所述至少一层的第二层中至少一层中的颜料,用于区别所述至少一层的第一层和所述至少一层的第二层中的至少一层。
31.如权利要求19所述的复合制品,其特征在于所述至少一层的第一层包括完全透明的材料,并且所述至少一层的第二层包括完全不透明的材料,所述复合制品还包括为所述至少一层的第一层材料提供可辨别颜色的颜料。
32.如权利要求20所述的复合制品,还包括颜料,其特征在于所述粘合剂包括含有硅酮的化合物,并且将所述颜料加入到所述含有硅酮的化合物中。
33.如权利要求19所述的复合制品,其特征在于所述至少一层第一层包括其中有小孔的聚合物薄膜。
34.一种治疗创伤的方法,包括如下步骤:
提供创伤敷料,当创伤敷料在第一位置取向时具有至少第一治疗性能,当创伤敷料在第二位置取向时具有至少第二治疗性能;
选择第一治疗性能和第二治疗性能中的一个或另一个,用于被治疗的创伤;
将创伤敷料应用到创伤上,使创伤敷料的取向在创伤敷料与创伤接触时发挥所选的治疗性能。
35.如权利要求34所述的方法,其特征在于提供一种在第一位置具有至少第一治疗性能在第二位置具有至少第二治疗性能的创伤敷料的步骤包括提供具有至少一层的第一表面和至少一层的第二表面的创伤敷料;
其特征在于选择第一治疗性能和第二治疗性能中的一个或另一个用于被治疗的创伤的步骤包括选择所述创伤敷料的所述第一表面和所述创伤敷料的所述第二表面中的一个或另一个;以及
应用创伤敷料的步骤包括将所述创伤与所选的表面接触。
36.如权利要求34所述的方法,还包括以下步骤:
允许所述创伤敷料与所述创伤保持接触;
从所述创伤上取下所述创伤敷料。
37.如权利要求34所述的方法,其特征在于提供创伤敷料的步骤包括提供具有至少一层的第一层和至少一层的第二层的创伤敷料,其特征在于每层具有用于创伤愈合的完全不同的性能;选择的步骤包括从第一治疗性能和第二治疗性能中选择一个或另一个用于被治疗的创伤;取向的步骤包括将所述至少一层的第一层和所述至少一层的第二层中的一层或另一层定位,使其与被治疗的创伤接触,应用所选择的治疗性能。
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CN104640520A (zh) * | 2012-07-10 | 2015-05-20 | 比奥梅达科学公司 | 用于第一急救者在烧伤中使用的新型医疗对策 |
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CN1898083B (zh) * | 2003-11-14 | 2012-09-19 | 比奥梅达科学公司 | 制备互穿聚合物网络薄片的改进方法及其有用制品 |
CN104640520A (zh) * | 2012-07-10 | 2015-05-20 | 比奥梅达科学公司 | 用于第一急救者在烧伤中使用的新型医疗对策 |
CN104640520B (zh) * | 2012-07-10 | 2018-11-09 | 比奥梅达科学公司 | 用于第一急救者在烧伤中使用的新型医疗对策 |
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IL150569A0 (en) | 2003-02-12 |
IL150569A (en) | 2009-09-01 |
ATE346575T1 (de) | 2006-12-15 |
CA2396218A1 (en) | 2001-07-12 |
WO2001049228A1 (en) | 2001-07-12 |
CA2396218C (en) | 2009-01-27 |
JP5014548B2 (ja) | 2012-08-29 |
DE60124876T2 (de) | 2007-06-28 |
CN1269464C (zh) | 2006-08-16 |
WO2001049228A8 (en) | 2002-01-03 |
US20010024656A1 (en) | 2001-09-27 |
KR20030062226A (ko) | 2003-07-23 |
AU2625701A (en) | 2001-07-16 |
KR100841124B1 (ko) | 2008-06-24 |
DE60124876D1 (de) | 2007-01-11 |
MXPA02006641A (es) | 2004-09-10 |
EP1267763A2 (en) | 2003-01-02 |
JP2004500179A (ja) | 2004-01-08 |
HK1053256A1 (en) | 2003-10-17 |
EP1267763B1 (en) | 2006-11-29 |
EP1267763A4 (en) | 2004-11-10 |
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