CN101983037A - 促进伤口愈合的设备 - Google Patents

促进伤口愈合的设备 Download PDF

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CN101983037A
CN101983037A CN2009801121072A CN200980112107A CN101983037A CN 101983037 A CN101983037 A CN 101983037A CN 2009801121072 A CN2009801121072 A CN 2009801121072A CN 200980112107 A CN200980112107 A CN 200980112107A CN 101983037 A CN101983037 A CN 101983037A
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R·F·维塔利斯
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Smith and Nephew Inc
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    • A61F13/00—Bandages or dressings; Absorbent pads
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    • A61F13/00—Bandages or dressings; Absorbent pads
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    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
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Abstract

一种促进伤口愈合的伤口治疗设备，包括被设置成放置在伤口上以限定伤口上的蓄池的伤口敷料，通过在伤口周围形成基本上液密密封的方式使伤口接触液保持在该蓄池中。为了对蓄池内的伤口接触液施加压力，可延展由伤口敷料限定的或者在伤口敷料中的弹性囊部件。与蓄池之间流体连通的流体系统，用来有选择性地将伤口接触液输送到蓄池，以及，与囊部件之间流体连通的压力系统，用来将受挤压的液体或气体输送到囊部件以影响囊部件的膨胀。

Description

促进伤口愈合的设备
相关专利的交叉引用
本发明要求2008年6月30日提交的美国临时专利申请No.61/076,753的优先权，可以在此参考引用该临时申请所公开。
背景
技术领域
本公开通常涉及一种产生和保持伤口周围的环境以促进伤口愈合的设备。本公开尤其涉及一种包括向伤口提供流体的流体系统和向流体提供压力的敷料的设备。
背景技术
身体的自然伤口愈合过程是在损伤时开始的一系列复杂事件。初始时，身体的反应是将蛋白和其他因子通过血流输送到伤口以使损害最小化。为了防止血液损失，血液发生凝结，同时细胞吞噬细菌和残屑，以将它带离伤口部位。接下来，身体开始在常常被称为“增殖”期的愈合阶段修复自身。该时期的特征在于肉芽组织沉积在伤口创面中。肉芽组织提供基础结构，在该基础结构上，细胞可以从外围向内迁移以闭合伤口。最后，随着时间推移，当胶原给新组织赋予足够的强度时，该过程结束，并常常形成疤痕。
在愈合过程中，身体具有一种分解坏死组织和残屑的自然倾向，从而清洁伤口并允许新细胞的形成。这种自然的过程常常被称为自溶性清创。一项促进自溶性清创和伤口愈合的技术包括向伤口施加压力。已经证明，通过促进血液流向该区域、刺激肉芽组织和借助自然过程迁移健康组织到伤口的方式向伤口施加正压和负压，对伤口的封闭和愈合是有效的。此外，变小的压力可以有助于消除从伤口渗出的流体，这可以抑制细菌生长。已被证明，这些技术对慢性的或不愈合的(non-healing)伤口是有效的，但也已被用于诸如术后伤口护理那样的其他目的。
允许伤口周围的环境加以控制的设备可以促进向伤口施加压力。因此，一种在伤口周围限定蓄池并可以控制在其中压力的设备的考量可以是有益的。
发明内容
本公开描述了一种促进伤口愈合的设备。该设备包括被设置成放置在伤口上以限定伤口上的蓄池的伤口敷料，通过在伤口周围形成基本上液密密封的方式使伤口接触液保持在该蓄池中。为了对蓄池内的伤口接触液施加压力，可延展由伤口敷料限定的或者在伤口敷料中的弹性囊部件。与蓄池之间流体连通的流体系统，用来有选择性地将伤口接触液输送到蓄池，以及，与囊部件之间流体连通的压力系统，用来将受挤压的液体或气体输送到囊部件以影响囊部件的膨胀。
可以连接弹性囊部件到基本上是非弹性的垫层，且可以连接该垫层到接触伤口周围的皮肤的身体附着层。囊部件的延展可以随后影响垫层中的张力，将伤口周围的皮肤向内拉。通过在外粘合环内嵌入内粘合环的方式，可以连接弹性囊部件到基本上是非弹性的垫层。内粘合环可以包围在蓄池和流体系统之间提供流体连通的流体连通入口。
可替换地，可以连接弹性囊部件到弹性垫层，且可以连接该垫层到向敷料提供双侧硬挺度的强化层。强化层可以包括用涤纶纤维形成的网筛，且可以用氨基钾酸酯构建该垫层。
伤口接触液可以包括诸如清创剂、抗菌剂、聚六亚甲基双胍、抗生素、生长因子或止痛剂那样的药剂以促进伤口愈合。流体系统可以包括可从设备上重复拆卸的注射器。
根据本公开的另一方面，一种促进伤口愈合的伤口敷料，包括被设置成放置在伤口上以限定伤口上的蓄池的基本上是弹性的垫层，通过在伤口周围形成基本上液密密封的方式使伤口接触液保持在该蓄池中。附着到垫层的强化层，以向伤口敷料提供双侧硬挺度并延展垫层的周围区域。为了对蓄池内的伤口接触液施加压力，可延展由伤口敷料限定的或者在伤口敷料中的弹性囊部件。弹性囊部件包括流体连通接口，通过该接口允许将伤口接触液引到伤口。可以连接垫层到入口部件，该入口部件包括允许引入伤口接触液的中心孔和允许可挤压的液体或气体引入囊部件的压力施加区域的不同的内分布环。
附图说明
包括在本说明书中的并且构成本说明书的一部分的附图示出了本公开的实施方式，并且与下面给出的实施方式的详细描述一起用来解释本公开的原理。
图1是依照本公开的伤口愈合设备的分解透视图；
图2是图1的伤口敷料的分解横断面图；
图3是用在伤口上的图1的伤口敷料的横断面图；以及
图4是依照本公开的伤口敷料的另一实施方式的分解横断面图。
具体实施方式
附图示出了本公开的示范性实施方式，并且被作为参考来描述在此描述的实施方式。在下文中，将通过解释附图的方式详细描述本公开，其中在几幅视图中，相同的参考数字表示相同的部件。
首先参考图1，通常用10描述根据本公开的在由健康的皮肤“s”围绕的伤口“w”上使用的伤口治疗设备。设备10包括放置在伤口“w”上以限定在该伤口上的可以在其中保持流体的蓄池14(图3)的伤口敷料12。设备10还包括与蓄池14之间流体连通的流体系统16，以及与伤口敷料12之间流体连通的压力系统18。入口部件20提供用于连接各种流体导管22，24到伤口敷料12以利于流体系统16和压力系统18之间流体连通的机构。
伤口敷料12是一种由一些不同层的叠压或并列而形成的复合敷料。首先，在敷料12的末梢或伤口贴面处放置隔离纸26。隔离纸26被配置成在将敷料12施加到伤口“w”之前保护敷料12，并且可以从敷料12移除和在即将应用敷料12之前丢弃。隔离纸26不需要用纸构造，但可以用包括聚氨酯、金属箔、聚烯烃和聚酯在内的任何适当材料来形成。
身体附着层28被放置在隔离纸26的临近侧。身体附着层28包括在横向上超过伤口“w”的周边的中央开口30，以便于身体附着粘合剂32可以与健康的皮肤“s”接触以在伤口“w”周围形成密封。为了形成合适的密封，身体附着粘合剂32可以用适配于在敷料12的边缘区域周围提供液密且防菌的密封的、医用级别的、压敏的粘合剂。用这种方式，伤口接触液34(参考图3)将不会溢出敷料12的边缘，而且外部污染物不会进入伤口区域。为了提供这种阻碍，身体附着粘合剂32可以，例如，根据所用的粘合剂，是1.0到10密尔阶厚。通常，可以使用高吸力强度(peal-strength)的粘合剂来防止偶尔的脱落、卷边或“起褶”(“flagging”)，即，在敷料的边缘处，敷料失去粘合或不能粘到皮肤“s”。限定身体附着粘合剂32的粘合剂可以包括，但不限于，医用级别的丙烯酸树脂、有机硅橡胶基或硅树脂粘合剂。优选地，可以使用那些由Tyco Healthcare Group LP(d/b/a有限公司)提供的商标为
Figure BPA00001252424300041
的包括敷料的粘合剂。
囊部件36放置在身体附着层28的中央开口30内。可替换地，囊部件36能够放置在身体附着层28上以覆盖或横穿中央开口30。囊部件36用可弹性形变的弹性体或类似材料构造，并包括穿过中央区域延伸的流体连通入口38。囊部件36的上表面包括在其上的永久性粘合剂的嵌入环40，42。内环40包围中央区域内的流体连通入口38，同时外环42在囊部件36的周边延展。在两个嵌入环40，42之间限定了压力施加区域44。
垫层48放置在囊部件36上。垫层48相对于囊部件36而言基本上是非弹性的并且可以用柔性的高分子膜构造。例如，垫层48可以包括具有0.8密尔到1.0密尔厚度的聚氨酯薄膜。提供足够的湿气传透率(MVTR)的膜是Tyco Healthcare Group LP(d/b/a有限公司)提供的以商标名为
Figure BPA00001252424300042
出售的透明膜。可以适于用在垫层中的其他材料包括由明尼苏达州圣保罗的3M提供的在TEGADERMTM商标名下的和由英国伦敦的Smith and Nephew公共有限公司提供的在OPSITETM商标名下出售的薄膜。
由于与嵌入的粘合环40，42相接触的缘故，垫层48被粘到囊部件36。流体孔50以与囊部件36的流体连通入口38相一致的方向穿过垫层48延展。流体孔50旁边连着一对压力提供孔52，以便于压力提供孔52与囊部件36的压力施加区域44连通。内粘合环40在流体孔50和压力提供孔52之间延展，以便于流体孔50和压力提供孔52在流体上不相连通。垫层48还粘到身体附着层28上，以便于敷料12可以在伤口“w”上形成蓄池14。
入口部件20以基本液密的方式粘到垫层48的上表面。在入口部件20的底面周边附近放置适当的粘合剂56以利于这个连接。可替换地，可以在垫层48的上表面放置粘合剂，或者其他可能恰当的液密装置。入口部件20包括中空的中央孔58，该孔提供流体孔50和通向流体系统16的流体导管22之间的流体连通。入口部件20还包括不同的内空气分布环60，该环提供压力提供孔52和通向压力系统18的流体导管24之间的流体连通。入口部件20可以包括在中央孔58内的止回阀(未示出)以及维持蓄池14和压力施加区域44内的流体的分步环60.
如上所述，流体系统16与蓄池14之间流体连通。流体系统16用于排空蓄池14而且还利用伤口接触液34供应蓄池14。伤口接触液34通常是底粘性流体，以便于它可以与伤口“w”的特定几何形状相一致，而且可以在愈合期间适配于伤口“w”的几何形状的改变。伤口接触液34可以包括诸如促进伤口愈合的药剂那样的有益试剂。药剂包括，例如，抗菌剂、聚六亚甲基双胍、生长因子、抗生素、止痛剂，等等。适当的药物还包括诸如紧密围绕和渗透坏死组织的化学合成物或酶那样的清创剂。
流体系统16包括输送伤口接触液34的注射器64。注射器64可以是能够重复移除且通过例如锁连接能够连接到设备10的。因此，在空状态下，可以连接注射器64到设备10来排出蓄池14，而且可以随后断开连接，以便于可以填充伤口接触液34。一旦填充了伤口接触液34，就可以再次将注射器64附着到所示的设备，以输送伤口接触液34到蓄池14。可替换地，流体系统16可以包括多个注射器、一个可逆电泵，或者类似的机构来控制蓄池14的内含物。可选择地将收集罐64连接到流体导管22，以在排空蓄池14期间接收任何伤口溢泌物或残屑。收集罐64是可移除的，以便于在将伤口接触液34输送到蓄池14时，伤口接触液34不需要流入或者流过罐64。
压力系统18与囊部件36的压力施加区域44之间流体连通。压力源66通过流体导管24、阀门68和入口部件20连接到压力施加区域44，以便于压力源66可以向压力施加区域44选择性地提供被挤压的液体或气体，例如空气。可以配置压力源26以连续或间歇的方式提供被挤压的液体或气体。
在使用中，可以使用伤口治疗设备10对如图3所示的伤口“w”施加压力。向限定蓄池14的伤口“w”的周围的皮肤“s”应用伤口敷料12。排空被敷料12下方捕获的周围环境的空气，且通过流体系统16输送伤口接触液34到蓄池。压力系统18输送被挤压的液体或气体到囊部件36的压力施加区域44，以便于囊部件36如箭头“A”所指的那样对伤口接触液34施加压力。伤口接触液34与伤口“w”的几何形状相一致并向伤口“w”输送有效的压力，以如箭头“B”所指的那样刺激伤口的愈合。一种有效的压力可以，例如，包括在伤口中的从5％到20％之间变化的细胞表面张力。
如这种方式中所使用的那样，敷料12可以用于促进伤口“w”的闭合。可以延展囊部件36以将施加的压力容纳到压力施加区域44。由于相对于囊部件36而言，垫层48基本上是非弹性的，所以垫层中的反作用力可以如箭头“C”所指的那样在伤口“w”的边缘施加内导向的力。
现在参考图4，通常用112描述根据本公开的伤口敷料的另一实施方式。伤口敷料112包括与伤口“w”周围的皮肤“s”形成液密密封的身体附着层128。身体附着层128的中央开口130内或者身体附着层128的交叠部分内置有下的囊部件136A。下的囊部件136A包括流体连通入口138，以允许将伤口接触液34引入到伤口“w”。通过嵌入的粘合环140，142，连接上囊部件136B到下囊部件136A。上囊部件136B包括流体连通入口138以及与压力施加区域144之间流体连通的压力提供孔146。在施加来自压力系统18的压力的情况下，上和下囊部件136A和136B都可以是弹性且可拉伸的。在敷料112的上表面，垫层148可以由诸如氮基钾酸酯那样的较有弹性的材料构造。垫层148包括分别提供与蓄池14和压力施加区域144之间流体连通的流体孔150以及压力提供孔152。
上囊部件136B和垫层148之间置有向敷料112提供双侧硬挺度的强化层162。强化层162可以在敷料112的外边缘处与身体附着层128重叠，以便于可以将敷料112中产生的反作用力导向围绕伤口“w”的皮肤“s”。可以用施加到强化层162或者垫层148的适当侧面的粘合剂170的轻薄外皮，将强化层162附加到垫层148。还可以用施加到强化层162或者上囊部件136B的适当侧面的粘合剂170的轻薄外皮，将强化层162附着到上囊部件136B。
强化层162可以包括涤纶(PET)纤维的网筛，该纤维提供良好的防水性，使得它适用于潮湿的伤口环境。可以用具有大孔尺寸的织物或非织物的强化物来形成PET纤维。一些PET强化物制造方法提供纤维接合点的互连，以产生在多个方向中呈现柔性的网筛，并且当被剪断时不会被拆散。因此，制造出来的PET强化物将会可以在强化垫层148或者向敷料112提供双侧硬挺度时具有有益的高抗剪硬度。一种可适于并入到强化层162的示范性材料是由DuPont提供的在
Figure BPA00001252424300061
的商标名下出售的。可替换地，可以用其他具有适当抗剪硬度的强化物或网筛结构来形成强化层。适当的结构的例子包括受挤压的热塑性丝网和有孔的薄膜。用于这种其他结构的适当材料包括PET、聚乙烯、尼龙和聚丙烯。此外，强化层162可以使用织物结构。可接受的织物材料可以包括棉纱、织物醋酸纤维和尼龙。
虽然为了清楚和理解的目的，已经通过图示和举例的方式在一定程度上详细地描述了前面的公开，但显而易见的是，在所付权利要求的范围内，可以做出某些改变和修改。

Claims (13)

1.一种促进伤口愈合的伤口治疗设备，包括：
被设置成放置在伤口上以限定伤口上的蓄池的伤口敷料，通过在伤口周围形成基本上液密密封的方式使伤口接触液保持在该蓄池中；
由伤口敷料限定的或者在伤口敷料中的弹性囊部件，该弹性囊部件是可延展的，以对蓄池内的伤口接触液施加压力；
与蓄池之间流体连通的流体系统，用来有选择性地将伤口接触液输送到蓄池；以及
与囊部件之间流体连通的压力系统，用来将受挤压的液体或气体输送到囊部件以影响囊部件的膨胀。
2.根据权利要求1的设备，其中连接弹性囊部件到基本上是非弹性的垫层，且连接该垫层到接触伤口周围的皮肤的身体附着层。囊部件的延展影响垫层中的张力，将伤口周围的皮肤向内拉。
3.根据权利要求2的设备，其中通过在外粘合环内嵌入内粘合环的方式，连接弹性囊部件到基本上是非弹性的垫层。
4.根据权利要求3的设备，其中内粘合环包围在蓄池和流体系统之间提供流体连通的流体连通入口。
5.根据权利要求1的设备，其中连接弹性囊部件到弹性垫层，且连接该垫层到向敷料提供双侧硬挺度的强化层。
6.根据权利要求5的设备，其中强化层包括用涤纶纤维形成的网筛。
7.根据权利要求5的设备，其中用氨基钾酸酯构建该垫层。
8.根据权利要求1的设备，其中伤口接触液包括促进伤口愈合的药剂。
9.根据权利要求8的设备，其中药剂包括清创剂。
10.根据权利要求8的设备，其中药剂包括抗菌剂、聚六亚甲基双胍、抗生素、生长因子和止痛剂。
11.根据权利要求1的设备，其中流体系统包括可从设备上重复拆卸的注射器。
12.一种促进伤口愈合的伤口敷料，包括：
被设置成放置在伤口上以限定伤口上的蓄池的基本上是弹性的垫层，通过在伤口周围形成基本上液密密封的方式使伤口接触液保持在该蓄池中；
附着到垫层的强化层，以向伤口敷料提供双侧硬挺度，该强化层延展基本上是弹性的垫层的周围区域；以及
由伤口敷料限定的或者在伤口敷料中的弹性囊部件，该弹性囊部件是可延展的，以对蓄池内的伤口接触液施加压力，该弹性囊部件包括流体连通接口，通过该接口允许将伤口接触液引到伤口。
13.根据权利要求12的伤口敷料，其中连接垫层到入口部件，该入口部件包括允许引入伤口接触液的中心孔，和允许可挤压的液体或气体引入囊部件的压力施加区域的不同的内分布环。
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CN111134779B (zh) * 2014-05-09 2023-04-18 3M创新知识产权公司 与负压和流体滴注一起使用的清创敷件
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