CN101257876B - 整装的伤口敷料装置 - Google Patents

整装的伤口敷料装置 Download PDF

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CN101257876B
CN101257876B CN2006800329563A CN200680032956A CN101257876B CN 101257876 B CN101257876 B CN 101257876B CN 2006800329563 A CN2006800329563 A CN 2006800329563A CN 200680032956 A CN200680032956 A CN 200680032956A CN 101257876 B CN101257876 B CN 101257876B
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wound dressing
wound
vacuum pump
dressing apparatus
parts
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H·A·帕特尔
D·艾奇逊
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Smith and Nephew Inc
Covidien LP
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Abstract

复合伤口敷料装置通过使用外部蠕动真空泵来促进伤口的愈合。外部蠕动泵向伤口施加真空压力，以便从伤口基底中有效吸走伤口流体或渗出液。外部蠕动泵系在伤口敷料上，是便携式的，优选是由病人携带在支承袋中，这使得病人可活动。而且，当将渗出液从伤口除去时，病人并不需要局限在治疗过程中的任意时间。

Description

整装的伤口敷料装置
相关申请的交叉引用
本专利申请要求美国临时专利申请No.60/714912的优先权，该美国临时专利申请No.60/714912在美国专利商标局的申请日为2006年9月7日。
技术领域
本申请涉及一种用于治疗开放伤口的装置，更具体地说涉及一种整装(self-contained)的伤口敷料装置，它具有外部便携式泵系统，该泵系统将伤口流体吸入由病人支承的收集罐中。
背景技术
伤口闭合涉及邻近该伤口的上皮和皮下组织朝着伤口中心迁移直到伤口闭合。遗憾的是，较大伤口或者已经受到感染的伤口很难闭合。在这样的伤口中，郁积(stasis)区域(即在该区域中，组织的局部胀大限制了血液向该组织的流动)形成于伤口表面附近。没有足够的血流，伤口周围的上皮和皮下组织不仅接收的氧和营养物质减少，而且还不能成功地阻止微生物感染，因此不能使伤口自然闭合。这样的伤口对于医疗人员多年来都是难题。
伤口敷料已经用于医疗行业，以便保护和/或方便开放伤口的愈合。一种流行技术是使用负压治疗，它也称为抽吸或真空治疗。已经发展了多种负压装置，以便能够除去过多的伤口流体(即渗出液)，同时隔离伤口以便保护伤口，并因此影响恢复时间。各种伤口敷料已经进行改进，以便促进开放伤口的愈合。
当使用伤口敷料时一直需要解决的问题包括容易使用、使伤口高效愈合、便携和负压控制能力。因此，还需要继续改进用于开放伤口的负压伤口敷料。
发明内容
根据优选实施例，伤口敷料装置包括：伤口敷料部件，该伤口敷料部件的尺寸设置成用于相对于伤口基底定位；便携式真空泵，该便携式真空泵与伤口敷料部件流体连通，用于施加低于大气压的压力，以便于从伤口敷料部件中除去流体，且该真空泵由病人的身体携带；以及收集罐，该收集罐由病人的身体携带，并与真空泵流体连通，用于收集从伤口敷料部件中除去的流体。优选是，真空源包括蠕动真空泵，并用于产生范围在大约20mmHg和大约500mmHg之间的、低于大气压的压力，更优选是大约75mmHg至大约125mmHg。收集罐可以包括吸收材料，以便容纳从伤口敷料部件中除去的流体。优选是，装置还包括身体支承袋，它用于安装在病人身上。身体支承袋可以有囊袋，用于保持收集罐和真空泵中的至少一个。
优选是，真空泵包括控制装置，以便控制它的操作。压力传感器可以与控制装置结合，以便在相对于伤口敷料部件的预定位置检测压力，并将相应信号发送给控制装置。控制装置可以包括控制器，该控制器用于控制或改变真空源的输出。优选是，真空泵包括整装的电池。
优选是，伤口敷料部件包括：下部部件，该下部部件可定位成邻近伤口基底；上部吸收部件，该上部吸收部件可定位得邻近下部部件；以及顶部部件。该上部吸收部件包括从以下组中选择的材料：泡沫材料、无纺复合织物、纤维素织物、超级吸收聚合物以及它们的组合。上部吸收部件还可以包括药剂、抗感染剂、抗菌剂、多卤苯酸(polyhexamethylene biguanide)(下文中称为“PHMB”)、抗生素、清创剂、镇痛剂、再生因子、维生素、生长因子和营养物质中的至少一种。
在另一优选实施例中，伤口敷料装置包括伤口敷料部件，该伤口敷料部件的尺寸设置成用于相对于伤口基底定位；便携式真空泵，该便携式真空泵与伤口敷料部件流体连通，用于施加低于大气压的压力，以便于从伤口敷料部件中除去流体，并有整装的电池，用于操作该真空泵；收集罐，该收集罐与真空泵流体连通，用于收集从伤口敷料部件中除去的流体；以及身体支承袋，该身体支承袋可安装在病人身上，并有囊袋，用于保持收集罐和真空泵中的至少一个。
还公开了一种用于方便伤口愈合的方法。该方法包括以下步骤：使伤口敷料部件相对于伤口基底定位；引入便携式真空泵，以便与伤口敷料部件流体连通，用于施加低于大气压的压力，以便于从伤口敷料部件中除去流体；使收集罐与真空泵流体连通，用于收集从伤口敷料部件中除去的流体；安装身体支承袋，该身体支承袋有保持囊袋；以及将收集罐和真空泵中的至少一个定位在身体支承袋的保持囊袋中。
附图说明
下面将参考附图介绍伤口敷料的不同实施例，附图中：
图1是根据本发明原理的整装的伤口敷料装置的局部剖视图，表示了伤口敷料部件、泵系统和收集罐；
图1A是沿图1的线1A-1A的剖视图，表示了伤口敷料装置的真空管；
图2是泵系统的示意图；
图3是表示用于容纳收集罐和/或泵系统的身体支承袋的视图；
图4是表示图3的身体支承袋的可选实施例的视图；以及
图5是表示整装的伤口敷料装置的可选实施例的视图。
具体实施方式
本发明的复合伤口敷料装置通过使用外部蠕动真空泵而促进伤口的愈合。外部蠕动泵向伤口施加真空压力，以便将伤口流体或渗出液有效地从伤口基底吸走。外部蠕动泵系在伤口敷料上，并是便携式的，优选是可由病人携带，该外部蠕动泵允许病人活动。而且，当将渗出液从伤口除去时，病人并不需要局限在治疗过程中的任意时间。
下面参考图1，图中表示了本发明优选实施例的伤口敷料装置100。伤口敷料装置100包括复合伤口敷料102和系在该伤口敷料102上的泵系统104。伤口敷料102呈这样的物品的形式：它具有布置成并列或重叠关系的多层。该多层包括但不局限于：底层106、填塞/吸收层108和无孔粘附顶层110。
底层106与伤口基底“W”直接接触。底层106通常为多孔和无粘附性的。这里使用的术语“无粘附性”是指材料并不粘附在伤口基底中和周围的组织上。这里使用的术语“多孔”是指材料包含大量小孔或孔隙，这些小孔或孔隙允许所有类型的伤口流体通过该材料而通向上面的敷料层。优选是，伤口流体通过多孔材料的通路为单向，这样，伤口渗出液不会流回至伤口基底。这种方向流动特征可以采用形成于材料层中的定向孔的形式，即吸收性与底层106不同的材料或者促进定向流动的选择特定材料的层叠材料。用作底层106的实例材料包括接触层，由Kendall Corp(TycoHealthcare的一个部门)出售的商标名为XEROFLO
Figure 2006800329563_0
。
此外，试剂例如水凝胶和药物可以粘在或涂覆在底层106上，以便降低伤口的生物负担，促进愈合以及降低与更换或除去敷料相关的疼痛。药物例如包括：抗菌剂、生长因子、抗生素、镇痛剂等。而且，当使用镇痛剂时，镇痛剂可以包括这样的机构，该机构将能够在除去或更换敷料之前释放该药剂。
靠近底层106的一层是填塞/吸收层108。填塞/吸收层108将吸收和捕获伤口流体和渗出液。用作填塞/吸收层108的示例材料包括抗菌剂敷料，由Kendall Corp(TycoHealthcare的一个部门)出售的商标名为KERLIX
Figure 2006800329563_1
。本领域技术人员应当知道，填塞/吸收层108可以形成为任意合适形状。对形状的仅有要求是，填塞/吸收层108优选为与伤口的特殊形状一致。
填塞/吸收层108还将用于减少伤口基底感染的机率。因此，填塞/吸收层108可以用药物处理。药物例如包括：抗感染剂例如防腐剂或其它合适抗菌剂或抗菌剂的组合、多卤苯酸(下文中称为“PHMB”)、抗生素、镇痛剂、再生因子例如维生素、生长因子、营养物质等，还可以简单地由等渗压盐溶液冲洗。
继续参考图1，顶层110包围伤口敷料102的周边，以便环绕伤口基底“W”，从而提供环绕伤口基底“W”周边的闭合密封。顶层110可以包括粘在伤口基底“W”周围区域上的粘接剂，或者可以包含具有粘接剂的附加层。粘接剂必须可粘在伤口基底“W”皮肤周围的组织“t”上，例如伤口周围区域，并可用于皮肤上，且没有接触恶化(例如，粘接剂优选是应当无刺激和不引起过敏)。粘接剂可以半渗透，以便允许所接触的皮肤呼吸和传递水汽。也可选择，粘接剂可以无渗透性。另外，粘接剂可以通过外部刺激(例如热或者给定的流体溶液或化学反应)来激励或去激励。粘接剂例如包括Kendall Corp.(TycoHealthcare的一个部门)的ULTEC水状胶质敷料。
优选是，顶层110呈安装在填塞/吸收层108附近的片材形式。在优选实施例中，顶层110的周边部分110P包括粘接剂，并固定在伤口基底“W”周围的组织“t”上。需要时，周边部分110P可以固定在底层102的周边上。应当知道，可除去的衬垫也可以用于在使用前保护顶层110的粘接剂表面。
顶层110可以包含柔性材料例如弹性材料或弹性体材料，该柔性材料密封伤口敷料102的顶部。在一个实施例中，顶层110包括透明敷料(由Kendall Corp.(TycoHealthcare的一个部门)制造，商标名为Polyskin II
Figure 2006800329563_2
)。Polyskin II
Figure 2006800329563_3
为透明的半渗透性材料，它允许水汽和氧与伤口部位交换，并提供了对于细菌和流体污染物的屏障。也可选择，顶层110可以为不可渗透。顶层110的透明性提供了对于伤口敷料的状态的视觉指示，特别是对于伤口敷料的层的饱和水平状态的视觉指示。顶层110还包括与伤口敷料102内部流体连通的真空口或连接器112。真空口112可以是通过普通装置而安装在顶层110上并与它连接的单独部件，或者可以与顶层110形成一体。真空口112可以有形成于其中的阀，例如单向阀，以便只允许渗出液沿一个方向流动，即朝着泵系统104离开伤口敷料102。真空口112用于与泵系统104可释放地连接，如后面所述，并可以包括或者不包括用于与泵系统可释放连接的结构。
还参考图1，下面将介绍泵系统104。泵系统104包括：真空源114；进口管道116，该进口管道116使得真空源114的进口侧与伤口敷料102的真空口112连接；以及收集罐118，该收集罐118通过出口管道120而与真空源114的出口侧连接。在可选方式中，收集罐118可以“成一直线”布置在真空源114和伤口敷料102之间。真空源114可以为任何类型的泵，它生物相容，并保持或抽吸足够的治疗真空水平。优选是，获得的真空水平在大约20mmHg和大约500mmHg之间的范围内，更优选是大约75mmHg和大约125mmHg之间的范围内。泵114可以取下、重新使用和/或重新充电。通常，泵114为隔膜或蠕动泵等，其中，活动部件通过使伤口敷料102产生压力降低的区域(例如真空区域)而将渗出液吸出伤口基底并进入伤口敷料。优选是，该压力降低的区域与伤口基底“W”连通，以便于从该伤口基底除去流体并送入填塞/吸收层108中。泵114可以通过本领域技术人员已知的任意方式来驱动。在本发明的优选实施例中，泵114为蠕动泵。一种合适的蠕动泵是由Kendall Corp.(TycoHealthcare的一个部门)制造的Kangaroo PET Enternal供给泵。另一合适的蠕动泵可以是由英格兰的Watson Marlow LTD制造的101 V/R pmy MK2型泵。优选是，蠕动泵产生从大约20mmHg至大约500mmHg范围内的、低于大气压的压力。合适的隔膜泵包括由德国的KNF Neuberger制造的NMP 850KNDC型泵。
进口和出口管道116、120可以为由弹性体和/或聚合材料制造的任意合适柔性管道。进口管道116优选是通过普通方式(包括摩擦配合、卡口连接、卡扣配合等)而与真空口112可释放地连接。收集罐118可以为任意柔性的一次性囊袋等。收集罐118可以包括超级吸收材料，例如超级吸收聚合物(SAP)、硅胶、聚丙烯酸钠、聚丙烯酰胺钾和相关化合物，以便固定或容纳伤口排出物或碎屑。收集罐118优选是透明，以便能够看到罐118的内部，从而帮助病人确定收集罐118的剩余容量和渗出液的特性。
参考图2，泵系统104优选是包括：内部的整装的电池源122；压力传感器或换能器124，用于监测伤口敷料内的压力；以及整装的调节或控制装置126。优选是，压力传感器124布置在伤口敷料102的内部，并通过电线128而与控制装置126电连接(图1)。一种合适的压力传感器是PCB Piezotronics，Inc.的Pressure部门的Dynamic ICP压力传感器。压力传感器124还提供用于帮助检测伤口敷料102中的泄漏的信息。电线128可以穿过真空口112和穿过进口管道116，或者在进口管道116的外表面上。也可选择，电线128可以穿过真空口112和、或进口管道116的壁中的导管或槽道。图1A表示了当电线128穿过管道116的槽道或管道116的中心管腔时的各种结构。优选是，控制装置126包含在泵114的泵壳体内。控制装置126可以包括马达控制器/驱动器130，该马达控制器/驱动器130包括处理和驱动软件或电路，以便根据由压力传感器124检测的压力和/或其它工作参数(包括工作时间限制等)而控制或改变通向泵114的马达的驱动电压。例如，马达控制器/驱动器可以被编程，以便只在起动后的预定时间中运行。通过控制装置126的控制，泵114的马达的输出可以增大或降低，或者起动或停止。调节或控制装置126还可以有警报器例如视觉、音频或触觉感官警报器(例如振动等)，以便当满足特定情况时(例如合适真空水平、真空的损失或泄漏)向病人指示。超控开关130可以包含在泵系统内，以便使病人能够在需要时选择地起动或终止泵的操作，而不需要从控制装置126输入。也可以考虑无线装置，以便通过控制装置126来操作泵114。
下面参考图3，图中表示了用于支承罐和/或泵114中的至少一个的身体支承袋134。如上所述，泵系统104用于安装在病人身体上，以便成为整装的入口单元。这样，泵系统104可以至少局部由身体支承袋134携带或支承。身体支承袋134通常包括囊袋136和至少一个条带138，优选是两个条带，用于将囊袋136固定在病人的身体上。身体支承袋134将至少接收和储存收集罐118和/或泵114。身体支承袋134可以戴在病人的腰部周围。这样为优选，它可以根据伤口的位置来减少所需的管道长度。此外，囊袋136可以位于病人的腹部附近，腹部可以充分提高隐藏系统的能力。进口和出口管道116、120可以通过带等而固定在身体上，或者也可选择，可以不固定，且布置在病人的衣服下面。这样，身体支承袋134使得病人能够在没有约束或限制的情况下运动，并在伤口排液和愈合过程中向病人提供完全的便携能力。
图4表示了身体支承袋的可选实施例。根据该实施例，身体支承袋140用于安装在病人的肩部上，并有囊袋142。在另一方面，身体支承袋140以与图3的身体支承袋类似的方式起作用。
在使用时，伤口敷料装置100位于伤口基底“W”内，如图1中所示，并以上面所述的方式固定在伤口“W”周围。泵114和/或收集罐118位于身体支承袋134(或支承袋140)的囊袋136内。身体支承袋134、140通过条带134而安装在病人的腰部、肩部、腿部等上面。进口和出口管道114、120可以通过带等而固定在病人身体上。然后，泵114进行起动，以便在伤口敷料100内产生低于大气压的压力(即真空状态)的区域。泵114可以通过人工超控开关130来起动，或者可以通过压力传感器124来起动，该压力传感器124检测伤口敷料装置100中的、低于大气压的压力的缺乏，并向控制装置126发送相应信号。控制装置126再起动泵114。当伤口敷料102内的、低于大气压的压力增加时，顶层110和填塞/吸收层108可以缩陷。流体从伤口基底“W”吸出进入伤口敷料102的填塞/吸收层106中。这些流体和/或渗出液可以在泵114的负泵送能量作用下从填塞/吸收层106中被除去。流体通过进口和出口管道116、120传送，以便收集在收集罐118中。一旦由例如压力传感器124检测为低于大气压的压力达到合适水平，压力传感器124向控制装置126发送信号。控制装置126可以终止泵114的操作，或者可以选择地改变泵114的速度或输出(例如降低)。在该真空状态，伤口流体和渗出液可以连续吸入填塞/吸收层106中。在一段时间后，通过压力传感器124的检测或病人的视觉检测，伤口敷料102可能失去它的真空状态。当达到合适的真空水平损失时，压力传感器124向控制装置126发送信号，以便起动或增大泵114的输出。泵114从填塞/吸收层108中除去流体，并在伤口敷料102中重新建立真空状态。如上所述，在可选实施例中，当例如病人看见收集罐118充满时，泵114可以通过人工超控开关130来起动。在伤口愈合过程中在一次应用或一系列应用中，该处理可以持续多次。
一旦伤口完全愈合，伤口封闭装置和泵系统可以被处理。身体支承袋也可以被处理，或者进行清洁以便随后使用。泵也可以进行消毒和重新使用。
图5表示了本发明的另一实施例。根据该实施例，伤口敷料装置200包括微型泵202，该微型泵202用于安装在吸收层204中。微型泵202的长度范围为从大约1至3英寸，并有相对较小的直径，优选是不超过大约1英寸。微型泵202可以为任意类型的泵，它可生物相容，并保持或抽吸足够的医疗真空水平。微型泵202可以取出、重新使用、和/或重新充电。微型泵202可以为隔膜、蠕动或旋转类型的泵等，其中，活动部件通过使伤口敷料装置200产生压力降低的区域(例如真空区域)而将渗出液吸出伤口基底并进入伤口敷料。优选是，该压力降低的区域与伤口基底“W”连通，以便于从该伤口基底除去流体和送入吸收层204中。微型泵202可以通过本领域技术人员已知的任意方式来驱动。在本发明的优选实施例中，微型泵202为蠕动泵。一种合适的微型泵由Hingham，MA的Piab Vacuum Products制造。优选是，蠕动泵产生从大约20mmHg至大约500mmHg范围内的、低于大气压的压力。
优选是，吸收层204为透明的泡沫填充敷料。该泡沫材料可以为弹性、吸收液体、多孔、基于聚合物的泡沫材料。该泡沫材料可以是可分配的液体，它至少部分固化成确定空心管的晶状结构，以便能够排出渗出液。泡沫材料可分配至伤口基底中，并可收缩，以便从泡沫材料槽道中排出空气。泡沫材料可以是可膨胀亲水性泡沫材料，它能够从伤口吸收流体和保持伤口基底湿润。由泡沫材料确定的空心管或空隙也提供了用于传导电、热、冷和超声波的装置。空心管或空隙还提供了用于组织生长的生物活性架。薄膜透明顶层205固定在伤口区域周围，以便包围伤口。
整装的电池源和控制电路可以安装在壳体206内，该壳体206与皮带208连接。皮带208用于安装在病人的身体上，例如环绕腰部区域，并可以包括VELCRO
Figure 2006800329563_4
装置，用于固定在病人周围。皮带208还可以支承罐210，该罐210通过管212而从泵202接收流体渗出液。管214从壳体206延伸至泵202，并可以包括电线等，用于操作该泵。在可选实施例中，管212可以包括电线(该电线例如在管腔内)，并从壳体延伸至泵202和罐210。
还可以考虑，伤口敷料装置可以包括用于刺激组织生长和/或愈合的外部装置或设备。例如，辅助治疗装置可以包含在伤口敷料装置中，以便施加电或机械能，用于组织的治疗，例如将电、热或振动能量引导至伤口区域，和/或通过皮肤将各种药物引入人体内。辅助治疗装置可以包含在泵202的壳体内，如参考标号216示意所示，并通过上述控制装置来操作。一种合适的辅助治疗装置可以包括超声波换能器。其它类型传感器也可以考虑包含在伤口敷料装置中，包括氧、化学药品、微生物和/或温度传感器。检测伤口区域附近的氧将帮助临床医生确定伤口愈合的状态。存在升高温度可以指示感染。泵系统可以包括与计算机连通的线路，例如通过无线装置的手持式PALM
Figure 2006800329563_5
装置。
尽管已经表示和介绍了本发明，但是它并不局限于所示详细情况，因为在不脱离本发明精神的情况下可以进行各种变化和代替。例如，可以设想，与本申请同时提交的、共同转让的PCT专利申请(ExpressMail Certificate No.EL985194525 US，它要求美国临时申请No.60/714812的优先权，该美国临时申请No.60/714812的申请日为2006年9月6日)的主题以及与本申请同时提交的、共同转让的PCT专利申请(Express Mail Certificate No.EL985194508 US，它要求美国临时申请No.60/714805的优先权，该美国临时申请No.60/714805的申请日为2006年9月7日)的主题可以包含在本发明中(各申请的全部内容都被本文参引)。因此，本领域技术人员使用常规实验可以清楚本发明的其它变化和等效物，且这些变化和等效物都将在由下面的权利要求确定的本发明精神和范围内。

Claims (13)

1.一种伤口敷料装置，它包括：
伤口敷料部件，该伤口敷料部件的尺寸设置成用于相对于伤口基底定位；该伤口敷料部件包括用于固定在伤口基底周围的顶部部件；
便携式真空泵，该便携式真空泵与伤口敷料部件流体连通，用于施加低于大气压的压力，以便于从伤口敷料部件中除去流体，且该真空泵由病人的身体携带并且具有控制装置，以便控制真空泵的操作；
位于伤口敷料部件内部的压力传感器，该压力传感器用于在相对于伤口敷料部件的预定位置检测压力，并将相应信号发送给控制装置；以及
收集罐，该收集罐由病人的身体携带，并与真空泵流体连通，用于收集从伤口敷料部件中除去的流体。
2.根据权利要求1所述的伤口敷料装置，其中：该低于大气压的压力范围在从75mmHg至125mmHg的范围内。
3.根据权利要求1所述的伤口敷料装置，其中：真空泵包括蠕动真空泵。
4.根据权利要求1所述的伤口敷料装置，其中：收集罐包括吸收材料，以便容纳从伤口敷料部件中除去的流体。
5.根据权利要求4所述的伤口敷料装置，其中：吸收材料是超级吸收材料。
6.根据权利要求5所述的伤口敷料装置，其中：超级吸收材料是超级吸收聚合物。
7.根据权利要求1所述的伤口敷料装置，还包括：身体支承袋，该身体支承袋用于安装在病人身上，并有囊袋，用于保持收集罐和真空泵中的至少一个。
8.根据权利要求1所述的伤口敷料装置，其中：控制装置包括控制器，该控制器用于控制或改变真空泵的输出。
9.根据权利要求1所述的伤口敷料装置，其中：真空泵包括整装的电池。
10.根据权利要求1所述的伤口敷料装置，其中，伤口敷料部件包括：下部部件，该下部部件可定位得邻近伤口基底；上部部件，该上部部件可定位得邻近下部部件；以及所述顶部部件。
11.根据权利要求10所述的伤口敷料装置，其中：上部部件包括从以下组中选择的吸收材料：泡沫材料、无纺复合织物、纤维素织物、超级吸收聚合物以及它们的组合。
12.根据权利要求11所述的伤口敷料装置，其中：上部部件包括药剂。
13.根据权利要求12所述的伤口敷料装置，其中：所述上部部件包括抗感染剂、抗菌剂、多卤苯酸、抗生素、镇痛剂、再生因子、维生素、生长因子和营养物质中的至少一种。
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