CN105555244A - 可塑造的粘附板片 - Google Patents
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Abstract
在本文中公开了用于联接和固连医疗器件器械的方法和器件。具体而言,公开了一件式可塑造粘附结构,其允许将附接板片定制成例如造口的大小和形状,同时允许用于将医疗器件附接至对象的柔性和安全性,医疗器件诸如造瘘术袋或其他器件。
Description
背景技术
可塑造以配合造口(stoma)的大小和形状的造瘘术板片(ostomywafer)的益处是已知的。例如见美国专利号No.6,840,924。此种设计适用于两件式造瘘术板片,造瘘术袋借助于可移除的联接件而配合至该两件式造瘘术板片。需要可以与具有一体的粘附板片的1件式造瘘术袋结合地使用的可塑造的造瘘术板片设计。
发明内容
在本文中公开了粘附结构,更具体而言,是可塑造的粘附结构,其用于围绕身体开口(诸如造口)相对于对象来密封医疗器械,诸如造瘘术器械。
在一些实施例中,可塑造的粘附件(moldableadhesive)包括:至少两个粘附层;和至少一层薄、柔性、弹性的膜,其在两个邻近的粘附层之间,以形成复合粘附结构,其中,该可塑造的粘附件通过使该复合粘附结构卷动或折叠到其自身上而形成,使得该复合结构的内表面在卷动时提供反作用力以允许卷动的复合粘附结构的边缘部分地回复至其原始的大小和形状。
在其他实施例中,在本文中公开的可塑造的粘附件还包括板片单元,其中,该可塑造的粘附件附接至该板片单元,以形成该板片单元的塑造表面,其中,该板片单元的塑造表面远离身体地朝向。在其他实施例中,该板片单元的塑造表面具有膜层,该膜层部分地跨过该表面而延伸,使得该膜的内开口比该表面的内开口大。在更多其他实施例中,该膜层是薄且柔性的。
在一些实施例中,在本文中公开的可塑造的粘附件提供用于造瘘术袋的面板的附接的粘附基础。在更多其他实施例中,该面板作为分开的元件而连接至该袋。在更多其他实施例中,该面板是粘附性的。
在一些实施例中,在本文中公开的可塑造的粘附件提供复合结构的外缘,其中,该外缘比该袋面板中的开口大。
在其他实施例中,在本文中公开的可塑造的粘附件的分开的粘附层包括相同的粘附配方。在更多其他实施例中,分开的粘附层包括不同的粘附配方。
在一些实施例中,该复合结构的外缘和内缘是闭合、不相交的几何轮廓。在另外其他实施例中,该轮廓包括圆锥形轮廓。在更多其他实施例中,该轮廓是圆形。在其他实施例中,该轮廓是多边形。
在本文中还公开了可塑造的医疗器件和器械。在一些实施例中,该医疗器件或器械是造瘘术器械,其包括可塑造的造瘘术板片和造瘘术袋,其中,该可塑造的造瘘术板片包括可塑造的粘附件。在一些实施例中,构成可塑造的造瘘术板片的可塑造的粘附件包括:至少两个粘附层;和至少一层薄、柔性、弹性的膜,其在两个邻近的粘附层之间,以形成复合粘附结构,其中,该可塑造的粘附件通过将使复合粘附结构卷动或折叠到其自身上而形成,使得该复合结构的内表面在卷动时提供反作用力以允许卷动的复合粘附结构的边缘部分地回复至其原始的大小和形状。
通过引用而进行的并入
在本说明书中提到的所有公开、专利、和专利申请通过引用而并入本文中,以至于好像各单独的公开、专利、或专利申请是被特别地且单独地指示为通过引用而并入的那样。
附图说明
本发明的新颖特征在所附权利要求中具体地阐述。将通过参考以下的详细说明来获得本发明的特征和优点的更好的理解,以下详细说明阐述了例示性的实施例,在这些例示性的实施例中,利用了本发明的原理,且其附图:
图1是可塑造的造瘘术板片的示例,其能够从造瘘术袋移除和分离。
图2是可塑造的造瘘术板片的示例。
图3A-G是操作中的可塑造的造瘘术板片的示例。在将造瘘术板片塑造至期望大小以配合造口开口之前,移除覆盖该可塑造的造瘘术板片的粘附表面的释放衬垫(图3A)。图3B示出对象的造口开口大小和形状对该可塑造的造瘘术板片的配合。通过使粘附件卷回其自身上,直到开口的期望大小和形状匹配对象的造口来操纵造瘘术板片上的可塑造粘附件(见图3C)。一旦配合,则移除可塑造的造瘘术板片的近侧上的释放衬垫(图3D),且将其围绕造口应用至对象的皮肤表面(图3E-G)。遍及造瘘术板片的远侧表面施加压力,以便确保粘附件与皮肤表面之间的良好粘结。
图4A-C是与该可塑造的造瘘术板片组合的造瘘术袋的示例。图4A绘出示范释放衬垫从袋板片的移除。然后通过轻轻地展开袋来允许空气进入该造瘘术袋,如图4B中例示的。然后将袋应用至可塑造的盘和皮肤(图4C)。将袋放置到可塑造的盘和皮肤上的任务可通过在放置在袋板片上之前在中心线处折叠袋而变得更容易(图4C,左面板)。
具体实施方式
如在本文中使用的,用语“近侧”描述接触或面对皮肤或身体的任何表面。“远侧”描述远离皮肤或身体地面对的任何表面。
在本文中公开了用于联接和固连医疗器件或器械的方法和器件。具体而言,公开了一件可塑造的粘附结构,其允许将附接板片定制成例如造口的大小和形状,同时实现用于将医疗器件(诸如造瘘术袋或其他器件)附接至对象的柔性和安全性。
公开的实施例基于在美国专利号No.6,840,924(其通过引用而整体并入本文中)中描述的多层粘附件的环。可塑造板片,例如造瘘术板片的粘附件的特征在于多层构造,该多层构造包括分开的粘附层。分开的粘附层可在配方方面与彼此不同,或者可包括相对于彼此相同的配方。具有弹性特性的柔性片放置在至少两个邻近的粘附层之间。
包括分开的粘附层和至少一个柔性片的复合结构可通过使内缘在其自身上方卷动来定形。在由此种复合材料制成的环的情况下,内侧直径可通过该卷动运动而增大。在此种卷动运动中,一个粘附层变开始与其自身接触,且足够有力地粘附至其自身,以抵抗展开回至其原始大小。预先配置为柔性、弹性膜的内层,以恢复至其原始构造。粘附力和复原力的该相互作用导致减小环中的塑造开口的大小。如果复合结构环的内侧直径被塑造为比造口稍大的大小,则相互作用力可导致开口轻微地合拢,这可形成围绕该造口的紧密配合。此种紧密配合是合乎需要的,因为其提供密封特性,以抵抗流出物在该造口与复合结构之间的泄漏。
应当注意的是,在许多情况下,卷动粘附件边缘,或者塑造粘附件边缘的方向是卷入到结构的远侧上。然而,在本文中描述的实施例不限于该方向,相反,在一些情况下,可能合乎需要的是在近侧粘附件表面上卷动粘附件,以便形成更好的密封,且降低流出物在造口与复合粘附结构之间的泄漏风险。
如果复合结构形成为平面的形状、封闭的几何形状,可选地具有不相交的内缘和外缘,例如,圆和环,那么此种形状的内缘可通过卷动或者塑造内缘而被调整,以配合造口的大小。虽然作为与可塑造的造瘘术板片结构结合的形状,环是最合乎需要的,但该环的内缘和外缘可以可选地由对称或不对称的多边形、或者其他合乎需要的几何形状来构造。
环的结构的外侧被形成为允许环的大小比造瘘术袋的粘附面板中的开口足够大。而袋面板中的开口必须足够大,以本身容易地配合在造口上,而不接触造口。在一个实施例中,袋粘附面板可包括多种开口,以在备选情况中允许此种间隙,即,造口大小和形状差异。类似地,开口必须不过于大,以至于当环和袋联接在一起时,袋粘附件不接触可塑造的粘附环。
环的表面可与膜构件配合。膜应优选地借助于匹配的环表面的粘附特性而被层叠至环的表面。膜应由抵抗流出物的材料制成,薄、柔性、且优选地无弹性。此种膜构件可包括例如聚氨酯、聚乙烯或不可润湿的其他材料,且其粘附至环的远侧粘附表面。此种膜构件还可提供用于附接于其的袋粘附件的一致的附接表面,且还允许擦去当环配合至造口时可从造口排出的流出物。膜的内缘还可用作限制件,塑造的环的内缘优选地不超出该限制件。
在备选实施例中,环还可用半柔性且无弹性的塑料膜层保护。此种结构可作用为在粘附层的塑造和定制期间保护环的表面。
在使用时,保护性的膜将被从待塑造的环的表面移除。在优选的实施例中,该表面是远侧表面。通过抓住且卷动暴露的粘附件的内缘,开口可扩大,以便其超过造口的大小。可选的保护性膜然后可从环的近侧表面移除。在将环附接至例如板片单元之后,环的内缘可被向内最终调整,以形成与造口的适贴配合(snugfit)。
在其他实施例中,可以对在该可塑造的造口板片的近侧表面上的结构进行塑造。例如,在将环附接至造口表面之后,可移除在袋的粘附面上的保护性覆盖物。袋粘附件然后可在塑造的环的上方居中且附接至其。袋粘附件与环之间的粘结可具有足够的强度和整体性,以形成薄且柔性的单个粘附板,与1件式造瘘术板片符合,但还可容易地塑造以定制配合多种造口形状和大小。
在一些实施例中,环和袋可作为分开的物品来包装和销售。在其他实施例中,环和袋可包装在相同的包装容器中。在更多其他实施例中,环可在包装单元中直接附接袋。在更多其他实施例中,环可与造口开口同心地安装在袋板片中,或者备选地,可在一个或两个轴线中偏移。
虽然已在本文中示出和描述了本发明的优选实施例,但对于本领域技术人员而言将是显而易见的是,此种实施例仅是作为示例提供的。现在,本领域技术人员将想到许多变型、改变、和置换,而不偏离本发明。应当理解的是,在本文中描述的本发明的实施例的各种备选方案可用于实践本发明。预期以下权利要求限定本发明的范围,且在这些权利要求和它们的等同物的范围内的方法和结构由其覆盖。
Claims (15)
1.一种可塑造的粘附件,其包括:
至少两个粘附层;和
至少一层薄、柔性、弹性的膜,其在两个邻近的粘附层之间,以形成复合粘附结构,
其中,所述可塑造的粘附件是通过使所述复合粘附结构卷动或折叠到其自身上而形成的,使得该复合结构的内表面在卷动时提供反作用力以允许卷动的复合粘附结构的边缘部分地回复至其原始的大小和形状。
2.根据权利要求1所述的可塑造的粘附件,还包括板片单元,其中,所述可塑造的粘附件附接至所述板片单元,以形成所述板片单元的塑造表面,其中,所述板片单元的塑造表面远离身体地朝向。
3.根据权利要求2所述的可塑造的粘附件,其中,所述板片单元的塑造表面具有膜层,所述膜层部分地跨过所述表面而延伸,使得该膜的内开口比所述表面的内开口大。
4.根据权利要求3所述的可塑造的粘附件,其中,所述膜层是薄且柔性的。
5.根据权利要求2所述的可塑造的粘附件,其中,所述可塑造的粘附件提供用于造瘘术袋的面板的附接的粘附基础。
6.根据权利要求5所述的可塑造的粘附件,其中,所述面板作为分开的元件而连接至所述袋。
7.根据权利要求5所述的可塑造的粘附件,其中,所述面板是粘附性的。
8.根据权利要求5所述的可塑造的粘附件,其中,所述复合结构的外缘比袋面板中的开口大。
9.根据权利要求1所述的可塑造的粘附件,其中,分开的粘附层包括相同的粘附配方。
10.根据权利要求1所述的可塑造的粘附件,其中,分开的粘附层包括不同的粘附配方。
11.根据权利要求1所述的可塑造的粘附件,其中,所述复合结构的外缘和内缘是闭合、不相交的几何轮廓。
12.根据权利要求11所述的可塑造的粘附件,所述轮廓包括圆锥形轮廓。
13.根据权利要求11所述的可塑造的粘附件,其中,所述轮廓是圆形。
14.根据权利要求11所述的可塑造的粘附件,其中,所述轮廓是多边形。
15.一种可塑造的造瘘术器械,其包括可塑造的造瘘术板片和造瘘术袋,其中,所述可塑造的造瘘术板片包括权利要求1的所述可塑造的粘附件。
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US201361857647P | 2013-07-23 | 2013-07-23 | |
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PCT/US2014/039432 WO2015012953A1 (en) | 2013-07-23 | 2014-05-23 | Moldable adhesive wafers |
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EP (2) | EP4119112A1 (zh) |
JP (1) | JP6574418B2 (zh) |
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AU (1) | AU2014293635B2 (zh) |
CA (1) | CA2918740C (zh) |
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ES (1) | ES2931311T3 (zh) |
HK (1) | HK1225267A1 (zh) |
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Also Published As
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ES2931311T3 (es) | 2022-12-28 |
EP3024424A1 (en) | 2016-06-01 |
EP3024424B1 (en) | 2022-10-19 |
AU2014293635B2 (en) | 2019-05-23 |
HUE059980T2 (hu) | 2023-01-28 |
US20160151197A1 (en) | 2016-06-02 |
JP6574418B2 (ja) | 2019-09-11 |
JP2016525412A (ja) | 2016-08-25 |
US10449082B2 (en) | 2019-10-22 |
CN105555244B (zh) | 2020-01-21 |
EP3024424A4 (en) | 2017-03-22 |
HK1225267A1 (zh) | 2017-09-08 |
PL3024424T3 (pl) | 2022-12-19 |
DK3024424T3 (da) | 2022-10-24 |
CA2918740C (en) | 2021-08-17 |
MX2016000798A (es) | 2016-05-24 |
EP4119112A1 (en) | 2023-01-18 |
AU2014293635A1 (en) | 2016-02-18 |
CA2918740A1 (en) | 2015-01-29 |
WO2015012953A1 (en) | 2015-01-29 |
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