CN111419540A - 可释放的医用布单 - Google Patents
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Abstract
本申请涉及可释放的医用布单。一种可释放的医用布单、以及具有该可释放的医用布单的***和方法,包括至少一个液体不可渗透的透湿层、一个压敏粘合剂层、以及一个具有多个孔口的软凝胶层。该软凝胶层被配置为邻近组织部位布置。该压敏粘合剂层的一部分延伸通过在该软凝胶层中的多个孔口而与组织部位接触。该软凝胶层与组织部位形成良好的密封并且延伸通过该多个孔口的该压敏粘合剂层与组织部位形成牢固但可释放的连接。
Description
本申请是申请日为2012年12月14日,申请号为201610247839.4,发明名称为“可释放的医用布单”的申请的分案申请。
申请日为2012年12月14日,申请号为201610247839.4,发明名称为“可释放的医用布单”的申请是申请日为2012年12月14日,申请号为201280061232.7,发明名称为“可释放的医用布单”的申请的分案申请。
背景
1.相关申请的交叉引用
本申请要求2011年12月16日提交的题为可释放的医用布单(RELEASABLE MEDICALDRAPES)的美国临时专利申请号61/576,774的优先权,其披露通过引用以其全文连接在此。
2.领域
本披露总体上用于粘附到患者身上的敷件,并且更具体地但并非限制,可释放的医用布单、***、以及方法。
3.相关技术说明
临床研究和实践已表明,在某一组织部位附近提供减压增进并加速了在该组织部位的新组织的生长。这种现象的应用很多,但是在伤口治疗方面,减压的应用已经特别成功。这种治疗(在医学界通常被称为“负压伤口治疗”、“减压疗法”或者“真空疗法”)提供了许多益处,可以包括更快的愈合和肉芽组织形成的增加。
在应用减压治疗的过程中,典型地将一种泡沫垫或其他歧管紧邻伤口放置,并且用布单覆盖,以形成一个密封空间,然后将减压施加于该密封空间。如果该布单发生泄漏,则需要额外的能量来克服泄漏并维持减压的治疗水平。
概述
根据一个说明性的非限制性的实施例,一种用于在患者身上的组织部位上提供密封的可释放的医用布单包括具有一个第一侧和一个第二面向患者侧的液体不可渗透的透湿层以及具有一个第一侧和一个第二面向患者侧的压敏粘合剂层。该压敏粘合剂层的第一侧连接至该液体不可渗透的透湿层的第二面向患者侧。该可释放的医用布单还包括形成有多个孔口并且具有一个第一侧和一个第二面向患者侧的软凝胶层。该软凝胶层的第一侧连接至该压敏粘合剂层的第二面向患者侧。该压敏粘合剂层被配置为当手压施加于该液体不可渗透的透湿层的第一侧时,至少部分地延伸通过在该软凝胶层中的多个孔口。
根据另一个说明性实施例,一种用于用减压来治疗在患者身上的组织部位的***包括一个紧邻组织部位布置的用于分配减压的歧管、一个布置在该歧管和完整皮肤的一部分上方以形成一个包含该歧管的密封空间的可释放的医用布单、以及一个流体连接至该密封空间的减压源。该可释放的医用布单包括具有一个第一侧和一个第二面向患者侧的液体不可渗透的透湿层以及具有一个第一侧和一个第二面向患者侧的压敏粘合剂层。该压敏粘合剂层的第一侧连接至该液体不可渗透的透湿层的第二面向患者侧。该可释放的医用布单还包括形成有多个孔口并且具有一个第一侧和一个第二面向患者侧的软凝胶层。该软凝胶层的第一侧连接至该压敏粘合剂层的第二面向患者侧。该压敏粘合剂层被配置为当手压施加于该液体不可渗透的透湿层的第一侧时,至少部分地延伸通过在该软凝胶层中的多个孔口。
根据另一个说明性实施例,一种治疗在患者身上的组织部位的方法包括:紧邻组织布置一个歧管用于分配减压并且用一个可释放的医用布单覆盖该歧管和完整皮肤的一部分。该可释放的医用布单包括具有一个第一侧和一个第二面向患者侧的液体不可渗透的透湿层、以及具有一个第一侧和一个第二面向患者侧的压敏粘合剂层。该压敏粘合剂层的第一侧连接至该液体不可渗透的透湿层的第二面向患者侧。该可释放的医用布单还包括形成有多个孔口并且具有一个第一侧和一个第二面向患者侧的软凝胶层。该软凝胶层的第一侧连接至该压敏粘合剂层的第二面向患者侧。该压敏粘合剂层被配置为当手压施加于该液体不可渗透的透湿层的第一侧时,至少部分地延伸通过在该软凝胶层中的多个孔口。该方法进一步包括用手摩擦该液体不可渗透的透湿层的第一侧,以便引起该压敏粘合剂层的至少一部分延伸进入该多个孔口并且与该完整皮肤接触。该方法还包括将减压递送至该歧管。
根据另一个说明性实施例,一种制造可释放的医用布单的方法包括提供具有一个第一侧和一个第二侧的软凝胶层,在该软凝胶层中形成多个孔口,并且提供具有一个第一侧和一个第二侧的液体不可渗透的透湿层。该方法进一步包括提供具有一个第一侧和一个第二侧的压敏粘合剂层并且将该压敏粘合剂层的第一侧连接至该液体不可渗透的透湿层的第二侧。该方法还包括将该压敏粘合剂层的第二侧连接至该软凝胶层的第一侧。将该压敏粘合剂层定位为延伸通过该多个孔口。
根据另一个说明性实施例,一种用于邻近在患者身上的组织部位形成密封空间的可释放的医用布单包括:具有在约15微米与约50微米之间的厚度的一个聚氨酯外层;邻近该聚氨酯外层的一个压敏粘合剂层;以及具有在约1200微米与约4100微米之间的厚度的形成有多个孔口的一个硅酮凝胶层。当用手摩擦该聚氨酯外层时,该压敏粘合剂层的一部分延伸通过该多个孔口而与组织部位接触。
根据另一个说明性的非限制性的实施例,一种用于在患者身上的组织部位上提供密封的可释放的医用布单包括具有一个第一侧和一个第二面向患者侧的液体不可渗透的透湿层以及具有一个第一侧和一个第二面向患者侧的第一网孔层。该第一网孔层的第一侧连接至该液体不可渗透的透湿层的第二面向患者侧。至少该第一网孔层的第二面向患者侧基本上涂覆有一种压敏粘合剂。该可释放的医用布单进一步包括具有一个第一侧和一个第二面向患者侧的第二网孔层。该第二网孔层的第一侧连接至该第一网孔层的第二面向患者侧。至少该第二网孔层的第二面向患者侧基本上涂覆有一种软凝胶。该第一网孔层的压敏粘合剂被配置为当手压施加于该液体不可渗透的透湿层的第一侧时,至少部分地延伸通过该第二网孔层的空隙部分。
根据另一个说明性的非限制性的实施例,一种用于邻近在患者身上的组织部位提供密封的可释放的医用布单包括具有一个第一侧和一个第二面向患者侧的液体不可渗透的透湿层、以及基本上涂覆有压敏粘合剂的第一多根线股。该多根线股连接至该液体不可渗透的透湿层的第二面向患者侧。该可释放的医用布单还包括基本上涂覆有软凝胶的第二多根线股。该第二多根线股至少部分连接至液体不可渗透的透湿层。该第一多根线股的压敏粘合剂被配置为当手压施加于该液体不可渗透的透湿层的第一侧时,至少部分地延伸越过该第二多根线股以便与患者接触。
本申请还涉及以下方面:
1)一种用于在组织部位上提供密封的可释放的医用布单,该可释放的医用布单包括:一个液体不可渗透的透湿层,该液体不可渗透的透湿层具有一个第一侧和一个第二侧;一个压敏粘合剂层,该压敏粘合剂层具有一个第一侧和一个第二侧,其中该压敏粘合剂层的第一侧连接至该液体不可渗透的透湿层的第二侧;一个软凝胶层,该软凝胶层具有多个孔口以及第一侧和第二侧,其中该软凝胶层的第一侧连接至该压敏粘合剂层的第二侧;并且其中该压敏粘合剂层被配置为响应于施加至该液体不可渗透的透湿层的第一侧上的力而至少部分地延伸通过在该软凝胶层中的多个孔口。
2)如项1)所述的可释放的医用布单,其中该软凝胶层包含硅酮。
3)如项1)所述的可释放的医用布单,其中该软凝胶层包含以下项之一:硅酮、水胶体、水凝胶、聚氨酯凝胶、以及聚烯烃凝胶。
4)如以上中任一项所述的可释放的医用布单,其中该压敏粘合剂层包含丙烯酸粘合剂。
5)如项1)-3)中任一项所述的可释放的医用布单,其中该压敏粘合剂层包含以下项之一:丙烯酸粘合剂或粘性硅酮粘合剂。
6)如以上中任一项所述的可释放的医用布单,其中该液体不可渗透的透湿层包含具有大于或等于约300g/m2/24小时的湿蒸汽传输率的聚氨酯膜。
7)如以上中任一项所述的可释放的医用布单,其中该液体不可渗透的透湿层包含具有在从约15微米到约50微米范围内的厚度的聚氨酯膜。
8)如以上中任一项所述的可释放的医用布单,其中这些孔口包括以下形状中的一种或多种:圆形、方形、星形、卵形、多边形、复杂曲线、狭缝、直线形、以及三角形。
9)如以上中任一项所述的可释放的医用布单,其中该多个孔口中的每个孔口具有在约6mm到约50mm的范围内的平均有效直径。
10)如项1)-8)中任一项所述的可释放的医用布单,其中该软凝胶层包含具有在约125微米到约1000微米范围内的厚度的硅酮。
11)如以上中任一项所述的可释放的医用布单,其中该软凝胶层包含具有在约5肖氏OO与约80肖氏OO范围内的硬度的硅酮。
12)如以上中任一项所述的可释放的医用布单,其中该压敏粘合剂层具有在约15克/m2与约70克/m2之间的涂层重量。
13)如以上中任一项所述的可释放的医用布单,进一步包括具有一个第一侧和一个第二侧的第一释放衬里,其中该第一释放衬里的第一侧紧邻该软凝胶层的第二侧。
14)如以上中任一项所述的可释放的医用布单,其中该压敏粘合剂层包括施加于该液体不可渗透的透湿层的第二侧的压敏粘合剂的图案层。
15)一种用于用减压来治疗组织部位的***,该***包括:一个歧管,该歧管被适配为紧邻组织部位布置并用于分配减压;一个可释放的医用布单,该可释放的医用布单布置在该歧管上并且被适配为形成包含该歧管的一个密封空间;一个减压源,该减压源流体连接至该歧管;并且
其中该可释放的医用布单包括:一个液体不可渗透的透湿层,该液体不可渗透的透湿层具有一个第一侧和一个第二侧;一个压敏粘合剂层,该压敏粘合剂层具有一个第一侧和一个第二侧,其中该压敏粘合剂层的第一侧连接至该液体不可渗透的透湿层的第二侧;一个软凝胶层,该软凝胶层具有多个孔口、一个第一侧、以及一个第二侧,其中该软凝胶层的第一侧连接至该压敏粘合剂层的第二侧;并且其中该压敏粘合剂层被配置为响应于施加至该液体不可渗透的透湿层的第一侧上的力而至少部分地延伸通过在该软凝胶层中的多个孔口。
16)如项15)所述的***,其中该软凝胶层包含硅酮。
17)如项15)所述的***,其中该软凝胶层包含以下项之一:硅酮、水胶体、水凝胶、聚氨酯凝胶、以及聚烯烃凝胶。
18)如项15)-17)中任一项所述的***,其中该压敏粘合剂层包含丙烯酸粘合剂。
19)如项15)-17)中任一项所述的***,该压敏粘合剂层包含以下项之一:丙烯酸粘合剂或粘性硅酮粘合剂。
20)如项15)-19)中任一项所述的***,其中该液体不可渗透的透湿层包含具有大于或等于约300g/m2/24小时的湿蒸汽传输率的聚氨酯膜。
21)如项15)-20)中任一项所述的***,其中该液体不可渗透的透湿层包含具有在从约15微米到约50微米范围内的厚度的聚氨酯膜。
22)如项15)-21)中任一项所述的***,其中这些孔口包括以下形状中的一种或多种:圆形、方形、星形、狭缝、卵形、多边形、复杂曲线、直线形、以及三角形。
23)如项15)-22)中任一项所述的***,其中该多个孔口中的每个孔口具有在约6mm到约50mm的范围内的平均有效直径。
24)如项15)-23)中任一项所述的***,其中该软凝胶层包含具有在约125微米到约1000微米范围内的厚度的硅酮。
25)如项15)-24)中任一项所述的***,其中该软凝胶层包含具有在约5肖氏OO与约80肖氏OO范围内的硬度的硅酮。
26)如项15)-25)中任一项所述的***,其中该压敏粘合剂层具有在约15克/m2与约70克/m2之间的涂层重量。
27)如项15)-26)中任一项所述的***,进一步包括具有一个第一侧和一个第二侧的第一释放衬里,其中该第一释放衬里的第一侧紧邻该软凝胶层的第二侧。
28)如项15)-27)中任一项所述的***,其中该压敏粘合剂层包括施加于该液体不可渗透的透湿层的第二侧的压敏粘合剂的图案层。
29)一种治疗组织部位的方法,该方法包括:
将一个歧管紧邻组织部位布置以用于分配减压;
用一个可释放的医用布单覆盖该歧管和组织部位的至少一部分,其中该可释放的医用布单包括:一个液体不可渗透的透湿层,该液体不可渗透的透湿层具有一个第一侧和一个第二侧,一个压敏粘合剂层,该压敏粘合剂层具有一个第一侧和一个第二侧,其中该压敏粘合剂层的第一侧连接至该液体不可渗透的透湿层的第二侧,一个软凝胶层,该软凝胶层具有多个孔口、一个第一侧、以及一个第二侧,其中该软凝胶层的第一侧连接至该压敏粘合剂层的第二侧,并且其中该压敏粘合剂层被配置为响应于施加至该液体不可渗透的透湿层的第一侧上的力而至少部分地延伸通过在该软凝胶层中的多个孔口;
施加力于该液体不可渗透的透湿层的第一侧,以便引起该压敏粘合剂层的至少一部分延伸进入该多个孔口并且与组织部位接触;并且
将减压递送至该歧管。
30)如项29)所述的方法,其中:该软凝胶层包含硅酮;该压敏粘合剂层包含丙烯酸粘合剂;并且该液体不可渗透的透湿层包含具有大于或等于300g/m2/24小时的湿蒸汽传输率的聚氨酯膜。
31)一种制造可释放的医用布单的方法,该方法包括:提供具有一个第一侧和一个第二侧的软凝胶层;在该软凝胶层中形成多个孔口;提供具有一个第一侧和一个第二侧的液体不可渗透的透湿层;提供具有一个第一侧和一个第二侧的压敏粘合剂层;将该压敏粘合剂层的第一侧连接至该液体不可渗透的透湿层的第二侧;并且将该压敏粘合剂层的第二侧连接至该软凝胶层的第一侧。
32)如项31)所述的方法,进一步包括:提供具有一个第一侧和一个第二侧的第一释放衬里;并且将该软凝胶层连接至该释放衬里的第一侧。
33)如项32)所述的方法,其中在该软凝胶层中形成多个孔口的步骤包括在第一释放衬里中形成多个孔口,该方法进一步包括将第二释放衬里邻近第一释放衬里的第二侧布置,从而与延伸通过在该软凝胶层和第一释放衬里中形成的多个孔口的该压敏粘合剂层的部分接合。
34)如项32)所述的方法,其中第一释放衬里是一种具有包含粘合剂释放的多个区域的聚乙烯释放衬里,该方法进一步包括使该多个区域与形成在该软凝胶层中的该多个孔口对准。
35)一种用于在患者身上的组织部位上形成密封空间的可释放的医用布单,该可释放的医用布单包括:一个聚氨酯外层,该聚氨酯外层具有在15微米与50微米之间的厚度;一个压敏粘合剂层,该压敏粘合剂层邻近该聚氨酯外层;以及一个硅酮凝胶层,该硅酮凝胶层具有在125与1200微米之间的厚度并且形成有多个孔口,其中该压敏粘合剂层的一部分被适配为当施加密封力于该聚氨酯外层时,延伸通过该多个孔口而与组织部位接触。
36)一种用于在患者身上的组织部位上提供密封的可释放的医用布单,该可释放的医用布单包括:具有一个第一侧和一个第二侧的液体不可渗透的透湿层;具有一个第一侧和一个第二侧的第一网孔层,其中该第一网孔层的第一侧连接至该液体不可渗透的透湿层的第二侧,并且其中至少该第一网孔层的第二侧基本上涂覆有压敏粘合剂;具有一个第一侧和一个第二侧的第二网孔层,其中该第二网孔层的第一侧连接至该第一网孔层的第二侧,并且其中至少该第二网孔层的第二侧基本上涂覆有软凝胶;并且其中该第一网孔层的压敏粘合剂被配置为当手压施加于该液体不可渗透的透湿层的第一侧时,至少部分地延伸通过该第二网孔的多个部分。
37)一种用于在组织部位上提供密封的可释放的医用布单,该可释放的医用布单包括:一个液体不可渗透的透湿层,该液体不可渗透的透湿层具有一个第一侧和一个第二侧;第一多根线股,该第一多根线股基本上涂覆有压敏粘合剂,并且其中该第一多根线股连接至该液体不可渗透的透湿层的第二侧;第二多根线股,该第二多根线股基本上涂覆有软凝胶,并且其中该第二多根线股至少部分连接至该液体不可渗透的透湿层;并且其中该第一多根线股的压敏粘合剂被配置为当施加力于该液体不可渗透的透湿层的第一侧时,至少部分地延伸越过该第二多根线股。
38)如项37)所述的可释放的医用布单,其中该第一多根线股形成一个网孔层。
39)如项37)所述的可释放的医用布单,其中该第二多根线股形成一个网孔层。
40)一种用于在患者身上的组织部位上提供密封的可释放的医用布单,该可释放的医用布单包括:一个液体不可渗透的透湿层,该液体不可渗透的透湿层具有一个第一侧和一个第二面向患者侧;一个粘合剂层,该粘合剂层具有一个第一侧和一个第二面向患者侧,其中该压敏粘合剂层的第一侧连接至该液体不可渗透的透湿层的第二面向患者侧;一个释放层,该释放层具有多个孔口并且具有一个第一侧和一个第二面向患者侧,其中该释放层的第一侧连接至该粘合剂层的第二面向患者侧;并且其中该粘合剂层被配置为当手压施加于该液体不可渗透的透湿层的第一侧时,至少部分地延伸通过在该释放层中的多个孔口。
41)如项40)所述的可释放的医用布单,其中该粘合剂层是压敏粘合剂的平面连续层。
42)如项41)所述的可释放的医用布单,其中该释放层是一个软凝胶层。
43)如项40)所述的可释放的医用布单,其中该粘合剂层包括第一网孔层,并且其中至少该第一网孔层的第二面向患者侧基本上涂覆有压敏粘合剂。
44)如项40)或项43)所述的可释放的医用布单,其中该释放层包括第二网孔层,其中至少该第二网孔层的第二面向患者侧基本上涂覆有软凝胶。
45)如项40)所述的可释放的医用布单,其中该粘合剂层包括基本上涂覆有压敏粘合剂的第一多根线股。
46)如项43)或项45)所述的可释放的医用布单,其中该释放层包括基本上涂覆有软凝胶的第二多根线股。
47)如项40)所述的可释放的医用布单,其中该液体不可渗透的透湿层包含具有在从约15微米到约50微米范围内的厚度的聚氨酯膜。
48)如项40)或项42)所述的可释放的医用布单,其中这些孔口包括以下形状中的一种或多种:圆形、方形、星形、卵形、多边形、复杂曲线、狭缝、直线形、以及三角形。
49)如项40)所述的可释放的医用布单,其中该多个孔口具有在约6mm到约50mm的范围内的平均有效直径。
50)如项42)所述的可释放的医用布单,其中该软凝胶层包含具有在约125微米到约1000微米范围内的厚度的硅酮。
51)如项42)所述的可释放的医用布单,其中该软凝胶层包含具有在约5肖氏OO与约80肖氏OO范围内的硬度的硅酮。
52)如项40)所述的可释放的医用布单,其中该粘合剂层包括施加于该液体不可渗透的透湿层的第二面向患者侧的压敏粘合剂的图案层。
通过参考以下附图和详细说明,这些说明性实施例的其他方面、特征和优点将变得明显。
附图简要说明
图1是用于用减压来治疗在患者身上的组织部位的***的一个说明性实施例的横截面图(其中一部分以正视图显示);
图2是可释放的医用布单的一个说明性实施例的分解透视图;
图3是图1的***的一部分的横截面详图;
图4是显示邻近组织部位的可释放的医用布单的另一个说明性实施例的一部分的横截面图;
图5是可释放的医用布单的另一个说明性实施例的一部分的横截面图;
图6是可释放的医用布单的另一个说明性实施例的一部分的横截面图;
图7是可释放的医用布单的另一个说明性实施例的分解透视图;
图8是图7的可释放的医用布单的平面图(从该第二面向患者侧来看);
图9是可释放的医用布单的一个说明性实施例的分解透视图;并且
图10是图9的可释放的医用布单的平面图(从该第二面向患者侧来看);
说明性实施例的详细说明
在以下说明性的非限制性实施例的详细说明中,参考了形成本文的一部分的附图。这些实施例以足够的细节进行了说明以便使得本领域的技术人员可以实施本发明,并且应当理解的是能够利用其他实施例并且可以作出合乎逻辑的、结构的、机械的、电力的、和化学的改变而不背离本发明的精神或范围。为了避免对于使得本领域的技术人员能够实践在此所述的这些实施例来说所不必要的细节,本说明可能省略了本领域的技术人员已知的某些信息。以下详细说明不应当被理解为限制性的意义,并且这些说明性实施例的范围仅仅由所附的权利要求书限定。
现在主要参考这些附图并且主要参考图1-3,呈现了用于用减压来治疗在患者104身上的组织部位102的***100。***100包括具有第一侧108和第二面向患者侧110的可释放的医用布单106。可释放的医用布单106提供针对组织部位102的密封。形成的密封基本上没有泄漏。可释放的医用布单106允许蒸汽流出可释放的医用布单106,维持与完整皮肤112的足够强的机械连接,易于应用,易于移除,并且在移除过程中对患者引起最小的疼痛。以下将更详细地描述可释放的医用布单106。
组织部位102可以是任何人类、动物、或者其他有机体的身体组织,包括骨组织、脂肪组织、肌肉组织、皮肤组织、血管组织、***、软骨、肌腱、韧带、或者任何其他组织。织部位102的治疗可以包括流体(例如渗出物或腹水)的去除。正如贯穿本文件所使用的,“或”不需要相互排斥。在图1-3的说明性实例中,组织部位102是患者104身上的伤口。在该说明性实施例中,该伤口延伸通过表皮116、通过真皮118,并且进入皮下组织120中。
紧邻组织部位102布置一个歧管122。该歧管122是被提供用于帮助将减压施加于一个组织部位102上、递送流体至该组织部位或将流体从该组织部位去除的一种物质或结构。歧管122包括能够分配提供到该组织部位102上以及从其去除的流体的多个流动通道或通路。在一个说明性实施例中,这些流动通道或通路相互连接以改进提供到该组织部位102上或从其去除的流体的分配。该歧管122可以包括以下项的一个或多个:一种能够放置成与组织部位102接触并且将减压分配到组织部位102的生物相容性材料;具有被排列为形成流动通道的结构元件的装置,例如像多孔状泡沫、开孔泡沫、多孔组织集合、液体、凝胶、以及包括或加工成包括流动通道的泡沫;多孔材料,例如,泡沫、纱布、毡垫或适合于具体生物应用的任何其他材料;包括充当流动通道的多个互相连接的孔(cell)或孔隙(pore)的多孔泡沫,例如聚氨酯开孔网状泡沫,例如由德克萨斯州圣安东尼奥市动力学概念公司(KineticConcepts,Incorporated of San Antonio,Texas)制造的材料;一种生物可再吸收材料;或一种支架材料。在一些情况下,还可以使用该歧管122将例如药剂、抗细菌剂、生长因子以及不同溶液的流体分配到组织部位102。
可释放的医用布单106被布置在歧管122和该组织部位的至少一部分上而形成一个密封空间124。密封空间124包含歧管122。一个减压源126流体连接至密封空间124。减压源126提供减压。减压源126可以是用于供应减压的任何装置,例如真空泵、壁吸装置(wallsuction)、微型泵、或其他源。虽然施加于组织部位的减压的量和性质将典型地根据用途而变化,但是减压典型地将在-5mm Hg(-667Pa)与-500mm Hg(-66.7kPa)之间,并且更典型地在-75mm Hg(-9.9kPa)与-300mm Hg(-39.9kPa)之间,并且还更典型地在75mm Hg(-9.9kPa)与-200mm Hg(-26.66kPa)之间。
一个减压接口128可以用来将一个减压递送导管130流体连接至密封空间124。由减压源126产生的减压通过该减压递送导管130递送到减压接口128。在一个说明性实施例中,减压接口128是可获自德克萨斯州圣安东尼奥市(San Antonio,Texas)的KCI公司的衬垫或Sensa衬垫。减压接口128允许减压递送到密封空间124。减压接口128还可以是***通过可释放的医用布单106的一个导管。还可以通过一种装置(例如直接连接至可释放的医用布单106的一个微型泵)产生减压。
主要参考图2和图3,可释放的医用布单106具有三个基本层(从最外层到接触患者的层):(1)一个液体不可渗透的透湿层132、(2)一个压敏粘合剂层138;以及(3)具有多个孔口146的一个软凝胶层144。液体不可渗透的透湿层132起着液体和微生物屏障的作用。压敏粘合剂层138提供了用于将液体不可渗透的透湿层132连接至软凝胶层144的手段。此外,在操作中,压敏粘合剂层138的一部分延伸通过多个孔口146与表皮116接触并且由此提供在可释放的医用布单106与患者104之间的接触连接152。接触连接是可释放的并且在使用过程中仍然提供粘附于患者104的充分连接。
液体不可渗透的透湿层132具有一个第一侧134和一个第二面向患者侧136。液体不可渗透的透湿层132允许蒸汽流出并且抑制液体退出。液体不可渗透的透湿层132是一种透气的柔性膜并且典型地具有高湿蒸汽传输率(MVTR),例如,大于或等于约300g/m2/24小时。液体不可渗透的透湿层132可以由一定范围的医学上认可的膜形成,这些膜在厚度上典型地在从约15微米(μm)到约50微米(μm)的范围,例如,15、20、25、30、35、40、45、或50微米(μm),或者在所陈述的范围内的任何数值。在替代性实施例中,可能使用低的或没有蒸汽传输的布单。
液体不可渗透的透湿层132可以包括多种材料,例如以下项的一种或多种:亲水性聚氨酯(PU)、纤维素制品、亲水性聚酰胺、聚乙烯醇、聚乙烯吡咯烷酮、亲水性丙烯酸酯、亲水性硅酮弹性体、以及这些的共聚物。作为一个特定的、说明性的、非限制性的实施例,液体不可渗透的透湿层132可以由一种在名称INSPIRE 2301下销售的透气的浇铸无光泽聚氨酯膜形成,这种INSPIRE 2301来自英国雷克瑟姆(Wrexham,United Kingdom)的亿塑派克高级涂料公司(Exopack Advanced Coatings)。这种说明性的膜具有14400g/m2/24小时的MVTR(倒杯技术)和大致30微米的厚度。
邻近液体不可渗透的透湿层132的是压敏粘合剂层138。压敏粘合剂层138具有一个第一侧140和一个第二面向患者侧142。压敏粘合剂层138可以是任何医学上可接受的压敏粘合剂。例如,压敏粘合剂层138可以包括丙烯酸粘合剂、橡胶粘合剂、高粘性硅酮粘合剂、聚氨酯、或其他物质。在一个说明性实例中,该压敏粘合剂层138包括具有15克/m2(gsm)到70克/m2(gsm)涂层重量的丙烯酸粘合剂。压敏粘合剂层138可以是连续的材料层或者可以是具有孔口的层(未显示)。这些孔口可以在施用压敏粘合剂层138之后形成或者可以通过将压敏粘合剂层138以模式涂覆在一个载体层(例如该液体不可渗透的透湿层132的第二面向患者侧136)上而形成。这些孔口可以被确定大小来帮助控制当压敏粘合剂层138被迫进入这些孔口146时的最终厚度。这些孔口还可以被确定大小来提高可释放的医用布单106的MVTR。
软凝胶层144具有一个第一侧148和一个第二面向患者侧150。软凝胶层144是一种提供与组织部位102的良好密封的柔软材料。软凝胶层144可以包括硅酮凝胶(或软硅酮)、水胶体、水凝胶、聚氨酯凝胶、聚烯烃凝胶、氢化苯乙烯共聚物凝胶、或具有所列出的组成的泡沫凝胶、或涂覆有粘合剂(例如,30gsm-70gsm的丙烯酸)的软闭孔泡沫(聚氨酯、聚烯烃)、聚氨酯、聚烯烃、或氢化苯乙烯共聚物。软凝胶层144具有典型地在约500微米(μm)到约1000微米(μm)范围内的厚度154。在一个实施例中,该软凝胶层144具有在约5肖氏(Shore)OO与约80肖氏OO之间的硬度。软凝胶层144可以是疏水的或亲水的。
软凝胶层144形成有多个孔口146。这些孔口146可以具有众多的形状,例如,圆形、方形、星形、卵形、多边形、狭缝、复杂曲线、直线形、三角形、或其他形状。多个孔口146的每个孔口146具有这样的有效直径,该有效直径是具有与孔口146相同表面积的圆形区域的直径。平均有效直径典型地是在约6mm到约50mm的范围内。多个孔口146可以具有均匀的模式或者可以随机分配在软凝胶层144上。
在组装状态下,压敏粘合剂层138的第一侧140连接至液体不可渗透的透湿层132的第二面向患者侧136。软凝胶层144的第一侧148连接至压敏粘合剂层138的第二面向患者侧142。软凝胶层144的第二面向患者侧150的初始粘性足以最初使得软凝胶层144与表皮116连接。一旦处于所希望的位置,将力施加于可释放的医用布单106的液体不可渗透的透湿层132的第一侧134上。例如,使用者可以摩擦可释放的医用布单106的液体不可渗透的透湿层132的第一侧134。这个动作引起压敏粘合剂层138的至少一部分被迫进入多个孔口146中并且与表皮116接触而形成接触连接152。接触连接152提供了与表皮116的安全的可释放的机械固定。
作为可释放的医用布单106的粘性或粘附强度的一个控制,用于软凝胶层144的多个孔口146的平均有效直径可以改变。在这一点上,在每个实施例的三个主变量:厚度154、多个孔口146的平均有效直径以及压敏粘合剂层138的粘性之间存在相互影响。压敏粘合剂层138延伸通过这些孔口146越多,则接触连接152的粘结就越强。软凝胶层144的厚度154越小,则压敏粘合剂层138总体上延伸通过这些孔口146就越多,并且接触连接152的粘结就越大。作为相互影响的实例,如果使用非常粘的压敏粘合剂层138,并且厚度154比较小,则多个孔口146的平均有效直径可以相对更小。在一个说明性的、非限制性的实施例中,该厚度154可以是大致200微米,压敏粘合剂层138是大致30微米并具有2000g/25cm宽条带的粘性,并且平均有效直径是大致6mm。
由于该压敏粘合剂层138经由多个孔口146形成接触连接152,所以可以通过液体不可渗透的透湿层132传输蒸汽。由于压敏粘合剂层138没有触及表皮116或组织部位102的其他方面,所以湿气必然弥合在组织部位102与压敏粘合剂层138之间的间隙。
在软凝胶层144和压敏粘合剂层138中还可以形成多个第二孔口156(图4)。在操作过程中,第二孔口156并不使得压敏粘合剂层138的任何部分延伸进入它们。第二孔口156可以进一步促进蒸汽传输通过液体不可渗透的透湿层132。
在可释放的医用布单106的制造、运输或使用中,可以使用许多释放构件。现在主要参考图5,呈现了一种可释放的医用布单106的一部分。可释放的医用布单106在大多数方面类似于图1-3的可释放的医用布单106,并且因此,标记了一些部件,但在此不进一步描述。在使用之前,将具有第一侧160和第二侧162的第一释放衬里158覆盖软凝胶层144的第二面向患者侧150。第一释放衬里158可以由高密度聚乙烯或促进从软凝胶层144的轻松释放的任何材料形成。此外,多个粘合剂-释放岛164分散在第一释放衬里158的第一侧160上,并且与多个孔口146对准。因此,如果任何压敏粘合剂层138延伸通过这些孔口146,则压敏粘合剂层138将与多个粘合剂-释放岛164接触。当准备好施用可释放的医用布单106时,使用者移除第一释放衬里158,由此暴露软凝胶层144的第二面向患者侧150并且可能暴露以可延伸通过这些孔口146的压敏粘合剂层138。
现在主要参考图6,呈现了一种可释放的医用布单106的一部分。可释放的医用布单106在大多数方面类似于图1-3的可释放的医用布单106,因此,标记了一些部件,但在此不进一步描述。在使用之前,用具有第一侧160和第二侧162的第一释放衬里158覆盖软凝胶层144的第二面向患者侧150。第一释放衬里158可以由高密度聚乙烯或促进从该软凝胶层144的轻松释放的任何材料形成。在这个实施例中,第一释放衬里158包括多个孔口166。多个孔口166与在软凝胶层144中的多个孔口146对齐或齐平。在一个说明性实施例中,多个孔口166和在软凝胶层144的多个孔口146是同时形成的。第二释放衬里168具有第一侧170和第二侧172。第一侧170施加于第一释放衬里158的第二侧162上,这样使得多个孔口166被第二释放衬里168覆盖。第二释放衬里168是由粘合剂-释放材料,例如聚烯烃(聚乙烯、聚丙烯、环烯烃共聚物)、聚酯、聚酰胺、纤维素制品(纤维素酯类)、以及纸形成的,任选地涂覆有适合的释放涂层(硅酮、含氟共聚物[例如氟硅酮]、聚烯烃蜡。
在另一个说明性实施例中,软凝胶层144是足够厚的并且第一释放衬里158是足够硬的,使得压敏粘合剂层138不会延伸通过这些孔口146。在这个实施例中,仅使用了第一释放衬里158。
可释放的医用布单106可以通过多种方式来制造。参考图6,根据一个说明性实施例,软凝胶层144浇注在第一释放衬里158的第一侧160上。多个孔口146和多个孔口166分别形成为通过软凝胶层144和第一释放衬里158。可以在材料沿着制造路径移动时使用穿刺这些材料的成形销钉或通过用具有成形销钉的滚筒沿着这些材料滚动来形成这些孔口146、166。这些成形销钉被配置为形成这些孔口146、166的所希望的形状和大小。然后可以将第二释放衬里168施加于第一释放衬里158的第二侧162上,以便与压敏粘合剂层138延伸通过这些孔口146、166的部分相接触。液体不可渗透的透湿层132施加于该压敏粘合剂层138的第一侧140上。在一个实施例中,压敏粘合剂层138被呈现为一种转移粘合剂并且用层压滚筒与压敏粘合剂138的第一侧140接触。然后将可释放的医用布单106完全组装,并且消毒和包装。液体不可渗透的透湿层132也可以涂覆有压敏粘合剂层138,该压敏粘合剂层可溶解于溶剂中抑或分散于连续相(可以是水)中,并且将该湿涂层干燥。
主要参考图1-3,在操作中,根据在***100背景中的可释放的医用布单106的一个说明性实施例,歧管122紧邻该组织部位102布置。然后将可释放的医用布单106施加于歧管122和组织部位102而形成密封空间124。在应用可释放的医用布单106时,将任何释放衬里(例如,第一释放衬里158或第二释放衬里168)移除,并且将软凝胶层144的第二面向患者侧138施加于完整皮肤112上和歧管122上。软凝胶层144的粘性最初将可释放的医用布单106保持在适当位置。该粘性这样,使得如果调整是希望的,则此时可以将可释放的医用布单106移除或重新施加。一旦获得希望的可释放的医用布单106的位置,使用者在液体不可渗透的透湿层132的第一侧134上施加手压。该手压引起该压敏粘合剂层138的至少一些部分延伸通过多个孔口146并且与表皮116接触而形成接触连接152。每一接触连接152是牢固但可释放的附接。
在另一个说明性实施例中,该可释放的医用布单106可以包括孔口以及其他允许脱离剂接触压敏粘合剂层138的工具。该脱离剂减弱了压敏粘合剂层138的粘性或粘附强度,从而易于从组织部位102移除。
在另一个替代性实施例中,该软凝胶层144不是坚固的软凝胶层,而是一种疏水涂覆材料。例如,软凝胶层144可以通过用一种疏水材料(例如,一种软的硅酮)涂覆一种间隔材料(例如,纺织的、无纺的、模制的或挤出的网)而形成。然后将疏水涂覆材料层压到该液体不可渗透的透湿层132(例如一种聚氨酯膜)上。通过这种方法,不一定形成孔口,因为压敏粘合剂层138可以延伸通过在该间隔材料中的开口。参见如下所述的图7-10。
在此描述的可释放的医用布单106的突出用途是产生用于减压治疗的密封空间124。然而,布单106可以用于其他目的。例如,布单106可以用来将一个无带胸罩(brazier)可释放地附接到人身上,用来将绷带粘附于患者身上,或用于对于人或动物而言可释放的附接是希望的任何其他目的。
根据一个说明性实施例,一个可释放的医用布单包括至少一个液体不可渗透的透湿层、一个压敏粘合剂层、以及一个具有多个孔口的软凝胶层。该软凝胶层紧靠患者的皮肤布置。该压敏粘合剂层的一部分延伸通过该多个孔口而与患者的皮肤接触。该软凝胶层与皮肤形成良好的密封并且延伸通过该多个孔口的该压敏粘合剂层与患者的皮肤形成牢固但可释放的连接。
现在主要参考图7-8,呈现了可释放的医用布单206的一个说明性实施例。可释放的医用布单206在许多方面类似于图1-6的可释放的医用布单106,并且因此,标记了一些部件,但在此不进一步描述。
可释放的医用布单206包括具有一个第一侧234和一个第二面向患者侧236的液体不可渗透的透湿层232。可释放的医用布单206具有:具有一个第一侧和一个第二面向患者侧的第一网孔层276。第一网孔层276包括互锁的第一多根线股277。第一网孔层276的第一侧连接至液体不可渗透的透湿层232的第二面向患者侧236。在这一点上,可以将第一网孔层276的第一侧层压到液体不可渗透的透湿层232的第二面向患者侧236上。可以使用其他连接技术。至少第一网孔层276的第二面向患者侧基本上涂覆有一种压敏粘合剂。
可释放的医用布单206进一步包括具有一个第一侧和一个第二面向患者侧的第二网孔层282。第二网孔层282包括互锁的第二多根线股283。第二网孔层282的第一侧连接至该第一网孔层276的第二面向患者侧或连接至该液体不可渗透的透湿层232的第二面向患者侧236。第二网孔层282的连接可以是层压或另一种连接技术。至少第二网孔层282的第二面向患者侧基本上涂覆有一种软凝胶。如最佳地在图8中显示,第一网孔层276和第二网孔层282未对准,因此线股277、283具有不重叠的主要部分。第一网孔层276的压敏粘合剂被配置为当手压施加于液体不可渗透的透湿层232的第一侧234时,至少部分地延伸通过第二网孔层282的空隙部分。
现在主要参考图9-10,呈现了可释放的医用布单306的另一个说明性实施例。可释放的医用布单306在许多方面类似于图7-8的可释放的医用布单206,并且因此,标记了一些部件,但在此不进一步描述。在可释放的医用布单306与可释放的医用布单206之间的主要差异在于这些线股377和383可能不形成网孔层,但是可能仅是单独的线股,即,这些线股没有互锁。例如,如在这些附图中显示的,第一多根线股377可以形成一个网孔层,例如第一网孔层376和该第二多根线股383可以形成一个松散层,例如第二层382。可替代地,第二多根线股383可以形成一个网孔层,但是第一多根线股377可以不形成网孔层。可替代地,第一多根线股377和第二多根线股383两者都可以形成松散层。
在一个实施例中,第一多根线股377基本上涂覆有一种压敏粘合剂。第一多根线股377连接至液体不可渗透的透湿层332的第二面向患者侧336。第二多根线股383基本上涂覆有软凝胶层。第二多根线股383可以平行于第一多根线股377中的一些或者可以采用不同的模式或者被随机放置。第二多根线股383至少部分连接至液体不可渗透的透湿层332。第一多根线股377的压敏粘合剂被配置为当手压施加于该液体不可渗透的透湿层332的第一侧334时,至少部分地延伸越过第二多根线股383以便与患者接触。
关于可释放的医用布单206和306两者,不需要形成孔口,因为将在多根线股277、283、377、383之间存在间隙或空隙空间。这些方法将多个液体不可渗透的透湿层直接暴露于湿气并且可以由此增强湿气传输。应当注意的是,在这些实施例中,该次序被显示为液体不可渗透的透湿层、第一多根线股、然后是第二多根线股,但是第一和第二多根线股可以次序相反。
虽然已经在某些说明性的非限制性的实施例的上下文中披露了本发明及其优点,应当理解的是可以作出不同的改变、替换、变换和变更,而不脱离如所附权利要求书所限定的本发明的范围。应当理解的是,连接任何一个实施例说明的任何特征也可以适用于任何其他实施例。
应当理解的是,以上说明的益处和优点可以涉及一个实施例或可以涉及若干实施例。将进一步理解的是,对‘一个/一种’(‘an’)物品的提及是指一个/一种或多个/多种那些物品。
在此所述的这些方法的步骤可以按任何适合的顺序进行,或在适当情况下同时进行。
在适当情况下,任何上述实施例的方面可以与任何所述的其他实施例的方面组合,从而形成具有可比较的或不同的特性并且着手解决相同或不同的问题的其他实例。
应当理解的是,以上对优选实施例的说明仅仅是通过举例而给出的,并且可以由本领域的技术人员做出各种修改。以上说明书、实例和数据提供了对本发明的示例性实施例的结构和用途的完整说明。虽然以一定的详细程度或参考一个或多个单独的实施例已经说明了本发明的不同实施例,本领域的技术人员能够针对所披露的实施例做出许多变更,而不偏离权利要求书的范围。
Claims (18)
1.一种用于在患者身上的组织部位上提供密封的可释放的医用布单,该可释放的医用布单包括:
具有第一侧和第二侧的液体不可渗透的透湿层;
具有第一侧和第二侧的第一网孔层,其中该第一网孔层的所述第一侧连接至该液体不可渗透的透湿层的所述第二侧,并且其中至少该第一网孔层的所述第二侧基本上涂覆有压敏粘合剂;
具有第一侧和第二侧的第二网孔层,其中该第二网孔层的所述第一侧连接至该第一网孔层的所述第二侧,并且其中至少该第二网孔层的所述第二侧基本上涂覆有软凝胶;并且
其中该第一网孔层的所述压敏粘合剂被配置为当手压施加于该液体不可渗透的透湿层的所述第一侧时,至少部分地延伸通过该第二网孔层的部分。
2.一种用于在组织部位上提供密封的可释放的医用布单,该可释放的医用布单包括:
液体不可渗透的透湿层,该液体不可渗透的透湿层具有第一侧和第二侧;
第一多根线股,该第一多根线股基本上涂覆有压敏粘合剂,并且其中该第一多根线股连接至该液体不可渗透的透湿层的所述第二侧;
第二多根线股,该第二多根线股基本上涂覆有软凝胶,并且其中该第二多根线股至少部分连接至该液体不可渗透的透湿层;并且
其中该第一多根线股的所述压敏粘合剂被配置为当施加力于该液体不可渗透的透湿层的所述第一侧时,至少部分地延伸越过该第二多根线股。
3.如权利要求2所述的可释放的医用布单,其中该第一多根线股形成网孔层。
4.如权利要求2所述的可释放的医用布单,其中该第二多根线股形成网孔层。
5.一种用于在患者身上的组织部位上提供密封的可释放的医用布单,该可释放的医用布单包括:
液体不可渗透的透湿层,该液体不可渗透的透湿层具有第一侧和第二面向患者侧;
粘合剂层,该粘合剂层具有第一侧和第二面向患者侧,其中该粘合剂层的所述第一侧连接至该液体不可渗透的透湿层的所述第二面向患者侧;
释放层,该释放层具有多个孔口并且具有第一侧和第二面向患者侧,其中该释放层的所述第一侧连接至该粘合剂层的所述第二面向患者侧;并且
其中该粘合剂层被配置为当手压施加于该液体不可渗透的透湿层的所述第一侧时,至少部分地延伸通过在该释放层中的所述多个孔口。
6.如权利要求5所述的可释放的医用布单,其中该粘合剂层是压敏粘合剂的平面连续层。
7.如权利要求6所述的可释放的医用布单,其中该释放层是软凝胶层。
8.如权利要求5所述的可释放的医用布单,其中该粘合剂层包括第一网孔层,并且其中至少该第一网孔层的第二面向患者侧基本上涂覆有压敏粘合剂。
9.如权利要求5或权利要求8所述的可释放的医用布单,其中该释放层包括第二网孔层,其中至少该第二网孔层的第二面向患者侧基本上涂覆有软凝胶。
10.如权利要求5所述的可释放的医用布单,其中该粘合剂层包括基本上涂覆有压敏粘合剂的第一多根线股。
11.如权利要求8或权利要求10所述的可释放的医用布单,其中该释放层包括基本上涂覆有软凝胶的第二多根线股。
12.如权利要求5所述的可释放的医用布单,其中该液体不可渗透的透湿层包含具有在从15微米到50微米范围内的厚度的聚氨酯膜。
13.如权利要求5或权利要求7所述的可释放的医用布单,其中所述孔口包括以下形状中的一种:圆形、卵形、多边形、复杂曲线、狭缝、以及直线形。
14.如权利要求13所述的可释放的医用布单,其中所述多边形是方形、星形、或三角形。
15.如权利要求5所述的可释放的医用布单,其中该多个孔口具有在6mm到50mm的范围内的平均有效直径。
16.如权利要求7所述的可释放的医用布单,其中该软凝胶层包含具有在125微米到1000微米范围内的厚度的硅酮。
17.如权利要求7所述的可释放的医用布单,其中该软凝胶层包含具有在5肖氏OO与80肖氏OO范围内的硬度的硅酮。
18.如权利要求5所述的可释放的医用布单,其中该粘合剂层包括施加于该液体不可渗透的透湿层的所述第二面向患者侧的压敏粘合剂的图案层。
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EP3005997A1 (en) | 2016-04-13 |
EP2802304A1 (en) | 2014-11-19 |
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JP6320930B2 (ja) | 2018-05-09 |
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JP2015501712A (ja) | 2015-01-19 |
US11969318B2 (en) | 2024-04-30 |
US20170252220A1 (en) | 2017-09-07 |
AU2012352000A1 (en) | 2014-06-05 |
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