CN101711719B - 具有可拆卸部分的压迫装置 - Google Patents

具有可拆卸部分的压迫装置 Download PDF

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CN101711719B
CN101711719B CN200910177631.XA CN200910177631A CN101711719B CN 101711719 B CN101711719 B CN 101711719B CN 200910177631 A CN200910177631 A CN 200910177631A CN 101711719 B CN101711719 B CN 101711719B
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R·阿维塔布莱
A·马希
R·K·丁金斯
J·布卢姆
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Abstract

一种用于对佩戴者身体的一部分施加压迫治疗的装置包括沿着装置的轴线彼此间隔开的第一和第二可充气囊。在第一和第二囊之间的连接段中减弱线大致横向于装置的轴线延伸以用于选择性地将可充气囊彼此分离。装置包括和第一和第二囊层中的一有大致相对关系的叠置层。叠置层在大致与减弱线相邻而不连续，以限定大致沿着减弱线延伸的叠置层的终端边缘界限。终端边缘界限中的每一个连接到与另一个终端边缘界限相对的减弱线的相对侧上的第一和第二囊层中的至少一个上。

Description

具有可拆卸部分的压迫装置
相关申请的交叉参考
本申请涉及2007年4月9日提交的如下共同转让的美国申请中的每一个：No.11/733,095；No.11/733,074；No.11/733,084；No.11/733,088；No.11/733,077；No.11/733,082；No.11/733,087；No.11/733,101，和2008年4月7日提交的No.12/098,884，这些申请的公开内容本文引入作为参考。
技术领域
本发明通常涉及一种用于对佩戴者的身体部分施加压迫治疗的压迫装置，更具体地说，涉及一种具有可拆卸部分的压迫装置。
背景技术
对于不能动的病人和类似人员的主要担心是在血液中形成血块，比如深静脉血栓(DVT)和末梢水肿的医疗状态。这样的病人和人员包括作过手术、麻醉、长时间卧床休息等的那些人。这些血块状态通常发生在下肢和/或骨盆的深静脉中。这些静脉，比如髂骨的、股骨的、腘的和胫骨的静脉使脱氧物质返回到心脏。例如，当这些静脉中的血液循环由于疾病、损伤或不活动而停滞时，便有血液积累或淤积的趋势。血液的静态淤积对于血块的形成是想象的。与这种状态相关联的主要危险是干扰心血管循环。最严重地，血块的碎片可打散并迁移。肺栓子能形成堵塞肺动脉，这可能有生命危险。
控制或减轻与病人不能动相关联的状态和生成危险可以通过将断续压力施加到病人的肢体，例如像腿上，以帮助血液循环。已知一些装置已经用来帮助血液循环，比如整体垫和压迫靴。例如参见美国专利No.6,290,662和No.6,494,852。
例如，已经使用连续压迫装置，这些装置包括由一系列气管连接到可处置包扎垫上的气泵。包扎垫环绕病人的腿放置。然后迫使空气顺序地进入包扎垫的不同部分，从而环绕腿肚产生压力并改善静脉血回流。
这些已知装置由于它们体积大和使用笨重的性质可能具有各种缺点。这些缺点降低了舒适性、顺从性，并且可能不利地阻止病人在手术后进行康复时的可动性。
因此，最理想的是，借助一种预防连续压迫装置来克服现有技术的不利情况和缺点，该预防连续压迫装置使体积减小，并在使用时不笨重，以改善对于病人的舒适性和顺从性。最理想的是，预防连续压迫装置包括可拆卸部分，以实现本公开的优点。具有可拆卸大腿段的压迫套公开于2004年2月24日提交的共同转让的美国专利申请No.10/784,607中，并且这个申请的公开内容由本文引入作为参考。所述大腿段能通过沿囊材料中设置的穿孔而撕开压迫套而被拆除。然而，这个申请没有解决与撕开不同组分的多层以脱开压迫装置的段而相关联的问题。
发明内容
在一个方面，一种用于对佩戴者身体的一部分施加压迫治疗的装置通常包括第一和第二相对囊(bladder)层，该第一和第二相对囊层沿着两条囊线彼此固定，以限定沿着装置的轴线彼此间隔开的第一和第二可充气囊。包括第一和第二囊层中的至少一个的一部分的连接段在第一和第二可充气囊之间延伸，并将它们彼此连接。在连接段中的减弱线大致横向于装置的轴线延伸，用于选择性地将可充气囊彼此分离。叠置层与第一和第二囊层中的一个具有大致相对的关系。叠置层在大致减弱线附近不连续，以限定通常沿着减弱线延伸的叠置层终端边缘界限。终端边缘界限每个连接到减弱线的与另一个终端边缘界限相对的一侧上的第一和第二囊层中的至少一个上。
在另一个方面，一种制造压迫装置的方法通常包括：沿着两条囊线将第一和第二相对的囊层彼此固定，以限定第一和第二可充气囊，所述第一和第二可充气囊沿着装置的轴线彼此间隔开并具有在第一和第二可充气囊之间延伸并将它们彼此相连的连接段。在连接段中形成减弱线，该减弱线大致横向于装置的轴线延伸，用于选择性地将可充气囊彼此分离。叠置层与第一和第二囊层中的一个按通常相对关系固定。叠置层在大致减弱线附近不连续，以限定相对终端边缘界限。终端边缘界限中的每一个固定到减弱线的相应的相对侧上第一和第二囊层中的一个上。
其它特征将部分显而易见，并且部分在下文中指出。
附图说明
图1是压迫套的一个实施例的正视图，该压迫套的外盖和套的囊层部分除去，以示出在下面的层；
图2是压迫套的分解透视图；
图2A是图1的放大局部视图，表示横过压迫套的左桥形件延伸的穿孔线；
图2B类似于具有穿孔线的图2A，包括圆形开口；
图2C类似于具有穿孔线的图2A，包括槽形开口；
图2D是在包括图2A中线2D-2D的平面中截取的截面图；
图2E是图1的放大局部视图，表示横过压迫套的右桥形件延伸的穿孔线；
图3是压迫套内层的后视图；
图4是外盖除去的压迫套的正视图；
图5是压迫套的纵向截面图，套的可充气囊处于充气状态；
图6是压迫套的纵向截面图，其可充气囊处于放气状态；
图7是外盖的放大局部视图，示出孔眼材料；
相应附图标记在全部附图中表示对应部分。
具体实施方式
现在参照附图，而特别是参照图1和2，压迫装置(广义地，“覆盖物或套”)的一个实施例通常用10表示，该压迫装置用于对佩戴者的肢体施加连续的压迫治疗。压迫套是为环绕佩戴者的腿设置一定尺寸和成形的类型，但可构造成用来应用于佩戴者身体的其它部分。更准确地说，套10具有用于环绕腿的整个周边包扎的宽度W(图1)、和从脚踝到大腿延伸的长度L(图1)。这种类型的套在本领域中通常称作大腿长度套，它包括大腿段11a、腿肚段11b和脚踝段11c。将要理解的是，压迫套可以有不同的尺寸，比如从脚踝到腿肚延伸的膝盖长度套(图20)。将要理解，用来环绕佩戴者身体其它肢体设置的其它类型的压迫装置均在本发明的范围内，比如在乳腺癌治疗中环绕病人胸部的包扎物。
由R.D.Kamm进行的数值研究，标题为“作为预防深静脉血栓的定期外部压迫的生物工程研究，第I部分：数值研究”(BioengineeringStudies of periodic External Compression as Prophylaxis AgainstDeep Vein Thrombosis-Part I：Numerical Studies)，其中得出结论“静脉的整个长度应当尽可能充分和快速放空”。Kamm研究回顾了三种类型的压迫，值得注意的一种是波浪状压迫。波浪状压迫与本发明举例说明的实施例提供的连续压迫最相似。Kamm研究发现，波浪状压迫对于有效预防治疗在运动血液方面最有效。
参照图1，压迫套10在本发明举例说明的实施例中包括固定在一起的四个层。本发明的范围不限于四个层。更准确地说，压迫套包括通常用12表示的内层，在该内层上叠置通常用14表示的第一中间层(广义地，第一囊层)。通常用16表示的第二中间层(广义地，第二囊层)叠置在第一中间层14上，并固定到其上。通常用18表示的外盖叠置和固定到第二中间层16上。在使用中，内层12与佩戴者的肢体最邻近设置，并且与佩戴者的肢体相接触，而外盖18离佩戴者的肢体最远。膝盖开口19穿过套10形成，当将套施加到腿上时，该膝盖开口19大致与膝盖的后部对准。各层具有相同的几何形状，并且彼此重叠，从而使各层的边缘通常重合。可以设想，层12、14、16或18中的一个或多个可不重叠在对应层上，而是稍微偏移，以适应病人肢体的特殊形状。此外，组成压迫套10的每个层12、14、16或18的薄片的数量或厚度可以与描述的不同。各层的厚度可以改变，以增加强度或在充气期间在一个方向上，如向着肢体造成更多的膨胀。
参照图1、2和4，第一和第二中间层14、16每个分别包括单片弹性材料(广义地，“囊材料”)。例如，薄片14和16由作为囊材料的易弯的PVC材料制成。层12和18由聚酯材料制成。第二中间层16经由三条分离的囊接缝线22a、22b、22c固定到第一中间层14上，这三条分离的囊接缝线22a、22b、22c分别限定沿着套10纵向地间隔开的近侧囊24a、中间囊24b和远侧囊24c。囊的数量在不脱离本发明的范围情况下可以不是三个。如本文使用的那样，术语“近侧”、“远侧”和“中间”表示当套被固定到佩戴者肢体上时为压迫套的元件、部分等的相对位置。因此，“近侧”元件或其它类似件与佩戴者肢体和佩戴者的躯干的连接点最邻近设置，“远侧”元件离连接点最远设置，而“中间”元件通常设置在近侧和远侧元件之间的任何地方。
因为下面论述的原因，近侧囊24a限定靠近套10的上边缘界限的近侧横向延伸部25。囊24a、24b、24c是环形囊，这意味着，它们按一定尺寸制造并定形成基本上环绕佩戴者肢体的整个周边或非常接近肢体的整个周边包扎。例如，在一个实施例中，囊24a、24b、24c每个环绕腿的中部周边的至少90％延伸。然而，现有技术的装置具有部分囊，比如
Figure GSB00000646826900051
和
Figure GSB00000646826900052
并且这些现有技术的装置不提供本发明的开口、弹性及其它特征。将要理解，本文描述的构造在不脱离本发明的范围情况下，可由具有部分囊构造的现有技术套采用。
中间层14、16可以通过射频焊接、粘合剂或其它化学和/或机械方法而被固定在一起。要理解，中间层14、16可以在其它位置固定在一起，比如环绕它们的周边和在囊接缝线22a、22b、22c处，以进一步限定可充气囊24a、24b、24c的形状。为了下面论述的目的，第一中间层14沿着接缝线25固定到内层12上(图5和6)，该接缝线25沿着第一中间层14的外周边延伸，以使囊24a、24b、24c的中心区不固定到内层12上。这样允许囊24a、24b、24c相对于内层12运动。第二中间层16也可以沿同一接缝线25固定到内层12上。第一中间层14可以通过RF焊接或粘合剂或以其它适当方式固定到内层12上。这种结构如下面所述的那样增进了舒适性。
参照图2和4，每个可充气囊24a、24b、24c分别从压缩流体源(未示出)经由专用的近侧囊管26a、中间囊管26b、和远侧囊管26c接受流体(图2)。为了实施本发明，管线不一定用在囊上。每个管26a、26b、26c设置在中间层14、16之间，并通过相应的囊接缝线22a、22b、22c固定到相应囊24a、24b、24c上。如图2和4中最清楚所示的那样，第二中间层16限定切口27(图2)，以使管26a、26b、26c的部分不设置在中间层之间。将管26a、26b及26c固定到囊24a、24b和24c上的其它方式均在本发明的范围内。管26a、26b、26c的相对端使用第二连接器30组合一起(图1和2)，该第二连接器30适合于将各管流体连接到压缩流体源上。压缩流体源可以是在微处理器控制下的空气压缩机，该空气压缩机连续地加压囊，如通常在本领域中已知的那样。典型的空气压缩机在授予Bock的美国专利No.5,876,359中有所描述，其公开内容由本文引入作为参考。囊24a、24b、24c可以构造成装有加压到至少大约10mmHg(1333Pa)至大约45mmHg(6000Pa)的空气。囊应能且无故障地被重复地加压。适用于薄片的材料包括、但不限于将不显著伸展的柔性PVC材料。在另一个实施例中，中间层可以形成用于容纳可充气囊的腔室，该可充气囊形成为与该腔室分离。在这个实施例中，只要可充气囊很有能力，各层可能不能装有加压空气。将要注意，囊24a、24b、24c能具有完全贯穿囊的开口32，如在本发明各实施例中描述的那样。
特别参照图1和4，套10限定包括在膝盖开口19相对侧上的一对桥形件84的连接段，该连接段在包括近侧囊24a的套的近侧部分到套的剩余部分之间延伸并连接它们。近侧管26a通常沿着桥形件84的轴线设置，以提供对套10的结构上和纵向支撑。如图4中最清楚所示的那样，中间薄片16中的切口27未贯穿桥形件84。近侧管26a在与桥形件84的远端相邻设置的间隔开远侧点焊点86之间、和在与桥形件的近端相邻设置的间隔开近侧点焊点88之间延伸。点焊点将管26a固定到桥形件84上，使得近侧囊管26a构成刚性结构件(广义地，“第一刚性结构件”)，用于保持在近侧囊24a与中间囊24b之间的空隙和保持连接段的纵向结构完整性。换句话说，套10被刚性化，防止压扁或沿佩戴者的腿滑下。如上说明的那样，近侧囊管26a在近侧的和横向延伸部25处固定到近侧囊24a上。近侧囊管26a沿着近侧囊24a的远侧部分一侧延伸，以使它到达近侧的横向延伸部25才能进入囊。被固定在囊24a的近侧的横向延伸部25处可对套10提供额外的纵向支撑，因为近侧囊管26a比如果该管被固定在囊的远侧部分处的时候纵向延伸跨过更多的套的近侧部分。在一个实施例中，近侧囊管26a延伸跨过套10的大腿段的路程至少四分之一。在图4中所示的另一个实施例中，管26a延伸跨过大腿段多于一半。这有助于使套10的近侧部分免于压扁和/或沿着佩戴者的腿滑出应有位置。
参照图2和4，除近侧囊管26a之外，设置在中间层14、16之间并在连接段的其它桥形件84内延伸的第二刚性结构件90还对套10提供纵向结构支撑。第二结构件90在桥形件84的近端与远端之间延伸。结构件90的有关近端和远端比该元件的中间部分宽，并且元件的周边大致与桥形件84侧壁的周边一致，以使结构件固定到桥形件上。
参照图1、3和4，近侧囊24a在与囊开口32相邻的点焊点92处并在由囊接缝线22a限定的囊的外周边内固定到内层12和外盖18上。点焊点92将外盖18和内层12保持在相对于囊24a、24b、24c的适当位置。换句话说，点焊点92防止囊24a、24b、24c相对于内层12和外盖18有显著移动，同时还为套10提供显著的柔软性。内层12和外盖18相对于囊24a、24b、24c的太大运动可能降低套的配合，由此导致压迫治疗的效率降低。近侧囊24a除在点焊点92处之外没有对内层12和外盖18固定，以保持套的柔软性，从而不损害病人腿的可动性。内层12可以在点焊点86、88、92处接合到层16上，或者内层12可以在开口32的接缝线34处接合。离开开口32和点焊点86、88、92，内层12未接合到形成囊的囊材料的表面上，该囊膨胀，以对病人的肢体提供压迫治疗。
在示出的实施例中，大腿段11a从套10的剩余部分可拆卸。特别是包括近侧囊24a和桥形件84的套10的近侧部分从套的剩余部分可拆卸。与桥形件84将大腿段11a接合到膝盖和脚踝段11b、11c上的地方相邻，包括中间层14、16中穿孔线93的撕开线(广义地，减弱线)跨越中间层横向延伸。在优选实施例中，拆除是破坏性和永久的。要理解，在本发明的范围内，套可以包括一条撕开线或者多于两条的撕开线。还要理解，在本发明的范围内，穿孔的形状可以是圆形的(图2B)或槽形的(图2C)或其它形状。除穿孔线93之外在撕开线处减弱套10的其它方式均在本发明的范围内。例如，撕开线可以包括中间层14、16的变薄部分。还要理解，撕开线可以用在除所示压迫套之外的其它类型的压迫装置中。例如，具有两个囊的压迫装置和具有多于三个囊的压迫装置也在本发明的范围内。进一步来说，撕开线可以设置成脱开套段的不同的段(即除大腿段11a之外)。
内层12和外盖18都没有线或减弱线，尽管这样一种构造被设想到并在本发明的范围内。而在图2A和2D中最清楚所示的那样，内层12和外盖18大致在中间层14、16的穿孔线93附近不连续，以便限定与穿孔线相邻的相应的相对终端边缘界限94。每条穿孔线93在内层12和外盖18的相应的相对终端边缘界限94之间设置。在示出的实施例中，内层12和外盖18的终端边缘界限94沿着与相应左和右桥形件84相关联的终端固定线95a、95b至少部分地被焊接或用其它方法固定到相应中间层14、16上。焊接线95a、95b与接缝线42邻接，从而将囊层14、16固定到内层12和外盖18上。与右桥形件84相关联的终端固定线95b中的每一条(图2E)都是连续的，并跨过桥形件延伸。然而，与左桥形件84相关联的终端固定线95a(图2A-2C)是不连续的，并且不跨过近侧囊管26a延伸。取而代之，终端固定线95a向桥形件84的中心稍微延伸，但折回并向下弯曲至终端边缘界限94的端部。固定线95a因而在囊管26a的相对侧上形成相对的向内突出部分，而方便于囊管的定位。然而，焊接线95a不永久地接合囊管26a，以使它能被去除，如下文描述的那样。
通常，每个终端边缘界限94都连接到穿孔线93的有关相对侧上的中间层14、16上。通过使内层12和外盖18在与中间层14、16中穿孔线93相邻的位置处不连续，比内衬和外盖是连续的并包括像在中间层中穿孔线那样的穿孔线的时候，套在穿孔线处更容易撕开。此外，套的耐撕力在终端固定线95a、95b处更大。在终端固定线95a、95b处的这种较大耐撕力便于套沿着穿孔线93更精确地撕开，并防止偶然显著地偏离撕开线。要理解，撕开线可以处于除所示之外的其它位置，用于从套10的剩余部分拆除大腿段11a。如示出的那样，膝盖和脚踝段11b、11c在它们之间没有撕开线。还要理解，在本发明的范围内，套10可以构造成具有除大腿段11a之外或代替它的其它可拆卸部分。
如前所述，近侧囊管26a在中间层14、16之间设置，并贯穿桥形件84中的一个。近侧囊管26a可拆卸地固定到连接器30上，以使近侧囊管能与连接器脱开，并使大腿段11a能从套10的剩余部分拆除。连接器30和近侧囊管26a可以是2004年2月23日提交的并转让本申请的受让人的待决美国专利申请No.10/784,607中公开的类型，该专利申请的全部本文引入作为参考。特别是连接器30允许在准备拆除大腿段11a时近侧囊管26a能非破坏性分开。因为近侧囊管26a大致横向于撕开线贯穿桥形件84中的一个，所以可能难以沿着中间层14、16中的对应穿孔线将套10撕开。因此，管检查口或窗96由外盖18中的开口96a和在第二中间层16中的对准开口96b形成。因为窗贯穿外盖18和与外盖相邻的第二中间层16而露出近侧囊管的一部分，所以在撕开套10之前便于近侧囊管26a从桥形件84上拆除。在示出的实施例中，管检查窗96大致是长方形的，并且延伸小于桥形件84的轴向全长。在使用中，近侧囊管26a能与连接器30分开，并且然后能被拉过管检查窗96，致使管不再延伸通过中间层14、16之间的撕开线。在管26a在对应撕开线处从中间层14、16之间拆除的情况下，沿着穿孔线93能容易地将套撕开，以拆除近侧部分，其中包括近侧囊24a和桥形件84。
在一个实施例中，囊24a、24b、24c被构造成朝向佩戴者比离开佩戴者膨胀的多，由此将较大压缩力施加在佩戴者的肢体上。在一个示例中，第一中间层14(即与内层12的最邻近层)具有比第二中间层16的厚度小的厚度。在两个层14、16均是相同材料(即弹性PVC材料)的情况下，第一中间薄片将具有较低弹性模量。因此，当空气被引入囊24a、24b、24c中时，囊将朝向内层12和佩戴者比离开佩戴者膨胀的多。要理解，除构造囊24a、24b、24c的中间层14、16之间的厚度差以使它们朝向佩戴者比离开佩戴者膨胀的多之外，其它方式均在本发明的范围内。
参照图2和3，内层12由能够吸去病人肢体附近水分的材料构成。要理解，内层12可以是其它构造，可以具有其它特征和性质，并且可以由除下面所述之外的材料形成。内(或“吸去”)层12通过毛细管作用吸附在佩戴者的腿或肢体附近捕集的水分，从肢体的表面上带走水分，再从富有水分的内层12处肢体上的位置将水分输送到开口32处水分较不富有的区域，以将其蒸发到周围环境中。开口在提供压迫的囊区域内可以具有各种尺寸、形状和位置。如与囊材料下面吸去层的部分相反，开口32将吸去层暴露于外界或周围空气中。与开口32对准的内层12的部分可以称作“暴露部分”。暴露吸去材料的其它方式在本发明的范围内，比如狭缝或将吸去材料延伸到囊材料的周边之外。本发明使其暴露部分在提供压迫的囊区域内。压迫区是在空气压力或其它流体的影响下膨胀和收缩的囊区域。不提供压迫的囊区域是接缝线或焊接点，这些焊接点是密封在一起的囊材料的点，以提供空气或水紧密边界或在囊周边之外的相对薄片14、16的其它区。吸去材料12可以与不透性材料交织，以形成内层12。吸去材料12将水分输送到较少水分的区域。开口32必须设计成保持血液速度，同时使水分蒸发最大化。适当的吸去材料可以包括例如某种形式的聚酯，尽管它们可以包括聚丙烯。可以使用微纤维。适当的微纤维材料包括但不限于由Quanzhou Fulian Warp Knitting Industrial Co.，Ltd.，QuanzhouCity，Fujian Province，China(中国福建省泉州市泉州福联经编工业有限公司)销售的CoolDry model number(型号)CD9604、和由特拉华州威尔明顿市E.I.du Pont de Nemours and Company，Wilmington，Delaware销售的
Figure GSB00000646826900111
论述了吸去层、开口、囊和外层的构造。开口必须设定尺寸和定形成以保持像型号9529之类的压迫套的血液流动效力和为增加病人的顺从性提供改进的水分蒸发。举例来说和没有限制，表1(下面)示出在短膝盖长度压迫套、中膝盖长度压迫套、中大腿长度压迫套、和长大腿长度压迫套中的每一个上开口32的典型百分比和开口面积。其它百分比和开口面积均在本发明的范围内。
表1
  短膝盖   中膝盖   中大腿   长大腿
  ％囊开口面积＊   1.64％   5.97％   9.44％   7.50％
  ％整个套的开口面积   0.94％   3.93％   4.44％   3.35％
  一个孔的开口面积英寸2＊＊   0.247   0.61   0.68-0.88   0.67-0.86
＊组合的所有三个囊。
＊＊大腿长度套在大腿囊中具有较大孔，因此提供一系列尺寸。
参照图1和4，套10这样构造，使中间层14、16的部分不叠置内层12，以便由内层12吸去的水分移动到内层12的开口部分，并蒸发到大气中。在这个示出的实施例中，每个可充气囊24a、24b、24c包括开口32，这些开口32分别贯穿第一和第二中间层14、16到内层12。形成这样一种开口的一个方式是使用连续密封线34在有关囊24a、24b、24c的周边内将中间层14、16密封在一起。在密封线34周边内的中间层14、16的部分能被拆除，比如通过切开，由此形成开口32。形成开口32的其它方式均在本发明的范围内。一旦开口尺寸和型式被确定，就铸成金属模具，以在对相对薄片的PVC囊材料中切出开口。
对于优选的实施例，开口形状大致成形像水滴那样。每个开口32从第一圆端部分向第二较小圆端部分逐渐变细。开口32在不脱离本发明的范围情况下可以是其它形状，比如圆形、椭圆形、和狭缝。开口形状在不脱离本发明的范围情况下可以在囊处相互混合。
对于每个囊24a、24b、24c，开口32以远侧行36和近侧行38排列(图4)。两行36、38沿着套10的宽度W延伸横过有关囊24a、24b、24c。如附图中描绘的那样，在每个近侧行38中的开口32是颠倒的中型水滴形开口，因为开口向远处逐渐变细，而在每个远侧行36中的开口是正面朝上，因为开口向近处逐渐变细。在每个远侧行36中的开口32从有关近侧行38中的开口沿着套的宽度W偏离。偏置开口32使开口横过囊24a、24b、24c的表面区域均匀分布，由此增加囊的呼吸能力和套10的总体呼吸能力，且不损害囊的结构完整性、或它们将压缩力(即预防治疗)施加到腿或身体部分上的能力。此外，偏置有关近侧和远侧行36、38中的开口还使囊24a、24b、24c在套10的横向方向上更加可伸展。除穿过囊的开口32之外，使由内层12吸去的流体能蒸发的其它方式也在本发明的范围内。
参照图1和2，压迫套10的外盖18由单片材料构成。外盖18是可呼吸的，并且具有多个开口40或穿孔，使其具有网状构造，以提供更均匀的呼吸能力。要理解，外盖18可以是其它构造，可以具有其它特征和性能，并且可以由除下述以外的材料形成。用于外盖18的适当材料可以是聚酯网状物。开口的蒸发率通过用亲水材料处理网状材料的纤维而得到改进。网状材料将更容易地吸收吸去的流体。这种类型的吸去纤维通常在图7中用21表示。这些亲水纤维降低了网状材料的表面张力，使体液更容易地能吸附到纤维中和通过它散开，以更有效地将吸去的流体蒸发。吸附流体将更容易使流体能更迅速地流动到开口区域蒸发。使毛细管效应更高效，因为在开口处被吸附的流体更迅速地穿过网状外盖18流动。
参照图1、5及6，外盖18沿着接缝线42被固定到第二中间层16上，该接缝线42只靠近第二中间层的外周边延伸，以使囊24a、24b、24c没有连接到盖上。第二中间层16可以通过RF焊接或粘合剂或以其它适当方式固定到内层12上。
参照图1和7，外盖18的全部外表面也起到将套10固定到佩戴者肢体上的紧固系统的紧固件的作用。在具体实施例中，网状物的外盖18(图7)例如具有包括孔眼44的外表面(图7)，这些外表面起到钩与孔眼紧固系统的孔眼元件的作用。如图7中所示，网状构造具有形成外盖18的材料的互连或纺织纤维21。孔眼44可以形成为外盖18的材料的部分，或者另外设置在外盖的表面上。具有这种构造的适当材料是由Quanzhou Fulian Warp Knitting Industrial Co.，Ltd.ofQuanzhou City(中国泉州市泉州福联经编工业有限公司)，China销售的聚酯接网状孔眼2103。钩元件46(图3)分别在近侧、中间及远侧舌片41a、41b、41c处连接到内层12的内表面上。当套10环绕佩戴者的肢体沿周边包扎时，外盖18的孔眼44使钩元件46(图3)能固定在沿着外盖的外表面的任何地方。这便于套10对不同佩戴者肢体的周边成为一种基本上一个尺寸适合全部的构造。此外，具有孔眼44的外盖18使开业医师能迅速而有把握地将套10固定到佩戴者肢体上，而不必对准紧固件。
可以设想，外盖18除可呼吸之外还能吸去流体。例如，外盖18可以用与内层12相同的材料(例如，Cooldry)制造。这样，由内层12吸去的水分可以经过囊24a、24b、24c中的开口32由外盖18吸去。水分然后越过外盖18将均匀地扩散，并能比外盖未由吸去材料形成的时候更容易地蒸发，因为与内层12相反，外盖有较大表面积暴露于空气中。可替换地，盖能具有在外层的顶部中或其上缀合的吸去材料。
压迫套10整个地佩戴更舒适，因为层12、14、16、18的协合关系。例如，内层12能够从肢体吸去水分，并使水分能从套10中蒸发。如上所述，吸去就是将水分从肢体输送出来，并将水分从其富有的位置移走，再将它输送到水分不太富有的区域。当水分等同地分布在吸去材料中并在吸去材料饱和时，材料降低其吸去率。然而，压迫套10的呼吸能力便于吸去的水分蒸发。囊24a、24b、24c和可呼吸外盖18中的水滴形开口32使靠近开口的内层12中的水分能从中通过蒸发。因此，随着水分蒸发，它被输送到内层12的较干燥部分，而使内层能够吸去更多水分。
为了改善病人可动性，套曾设计成具有弹性的内层12和外盖18。弹性套改善了舒适性，这又增加了病人的顺从性。下面关于弹性的论述参照图1-7。弹性装置将与病人的肢体相符，以保证连续吸去。顺从或基本上一致配合将有助于保证在使用期间囊对病人皮肤的接触。囊施加压力，以使血液流动。弹性外层有助于减少将套保持就位的束带的数量，因为弹性外层18返回其原始形状，从而对着病人肢体施加轻微的力。这个力有助于将套保持就位，并还使开业医师不能过度扎紧束带。一些现有技术的装置在压迫套下面使用弹性袜，比如T.E.D.
Figure GSB00000646826900141
袜。至少一些实施例的压迫套避免了如下两个步骤过程：首先将压迫袜放置在病人身上，然后将套放置在袜上。本发明优选实施例的套还简化了护士的工作，因为不必订购袜和套。
本申请人设计了一种弹性试验，用于确定环绕肢体和沿着肢体的伸展量。病人在治疗期间需要活动。现有技术的套可能笨拙、僵硬又沉重，所以如果使用者需要动来动去，则要除去装置。所述需要是改进弹性，而不使开口32变形太多，比如变成细长的或使开口叠置，这样减小其用于蒸发的尺寸。
例如，内层12优选地沿着套10的宽度W可弹性地伸展，以使内层能够沿周边与佩戴者肢体的形状相符。沿周边相符使内层12能保持与佩戴者肢体紧密、密切和连续接触，以保证内层连续地从肢体吸去水分。内层12也能沿长度L可伸展。优选地，内层12沿着套的宽度W和长度L都可弹性地伸展，并且沿着套10的长度比沿着宽度更能可弹性地伸展的多。使用下述试验概述优选的方法，内层12在套的横向方向上可以具有大约13磅/英寸(23N/cm)到大约14磅/英寸(25N/cm)之间的平均弹性，并且在一个实施例中具有大约13.3磅/英寸(23.3N/cm)的弹性。内层12在套的纵向方向上可以具有大约0.5磅/英寸(0.9N/cm)到大约0.7磅/英寸(1.2N/cm)之间的平均弹性，并且在一个实施例中具有大约0.63磅/英寸(1.10N/cm)的弹性。在内层12中的小开口20还便于内层伸展的更多。
外盖18沿着套10的长度L也可弹性伸展，或者沿着纵向和横向(沿圆周)都可伸展。优选地，外盖18在纵向比在横向有更大弹性。尽管可弹性伸展，但外盖18仍起约束囊24a、24b、24c的膨胀量的作用。外盖18有助于使囊与肢体相符，以助于均匀地施加用于使血液流动的压力。例如，使用下述的弹性试验，外盖18在横向方向上可以具有在大约13磅/英寸(23N/cm)到大约15磅/英寸(26N/cm)之间的平均弹性，并在一个实施例中具有大约13.6磅/英寸(23.8N/cm)的弹性。外盖18在纵向方向上可以具有大约19磅/英寸(33N/cm)到大约22磅/英寸(39N/cm)之间的平均弹性，并在一个实施例中具有大约19.8磅/英寸(34.7N/cm)的弹性。
压迫套10整个地通过可纵向伸展的内层12、中间层14、16和外盖18可纵向地伸展。另外，压迫套10通过内层12、中间层14、16和外盖18横向伸展的能力可横向稍微伸展。水滴形开口32和开口横向偏置的事实，也有助于横向伸展。
常见的是，已作手术的病人发生肢体肿胀。压迫套10的横向伸展对于感到肿胀的病人更舒适，因为随着肢体肿胀，套将伸展，即沿周边增大尺寸。此外，套10的弹性使佩戴者他或她的肢体能具有更大可动性，并当环绕佩戴者的腿包扎套时给开业医师更大的自由度。例如，使用下述的弹性试验，包括如上所述的内层12、中间层14、16和外盖18的大腿长度套10，在横向方向上可以具有大约22磅/英寸(39N/cm)到大约27磅/英寸(47N/cm)之间的平均弹性，并在一个实施例中具有大约24.3磅/英寸(42.6N/cm)的弹性。压迫套10在纵向方向上可以具有大约17磅/英寸(30N/cm)到大约22磅/英寸(39N/cm)之间的平均弹性，并在一个实施例中具有大约19.4磅/英寸(34.0N/cm)的弹性。
在另一个示例中，使用下述的弹性试验，包括与上述大腿长度套相同材料制的内层、中间层和外盖的膝盖长度套在横向方向上可以具有大约22磅/英寸(39N/cm)到大约27磅/英寸(47N/cm)之间的平均弹性，并在纵向方向上具有大约33磅/英寸(58N/cm)到大约40磅/英寸(70N/cm)之间的平均弹性。
以下试验(本文称作“弹性试验”)被用来测量在横向和纵向两个方向上层12、14、16与18和套10的弹性。首先，将结构夹具固定到待试验的结构(例如，层12、14、16与18或套10中的一个)上。当测试纵向弹性时，将结构夹具固定到结构的顶部和底部边缘上。当测试横向弹性时，将结构夹具固定到结构的相对侧边缘上。具有结构夹具固定到其上的套试样通过将结构夹具固定到机器的相对机器夹具上而被置于通用拉伸试验机(比如由宾夕法尼亚州格罗夫市制造的通用试验机)上。机器应当包括微处理器，该微处理器使用拉力测量程序来控制机器和记录力和位移的测量值。一旦结构被固定在机器中，相对机器夹具就被移到消除结构中的松弛或使其最小化的位置运动。这个位置是用于所有以后试验的初始位置。然后执行拉力测量程序。当机器夹具运动离开时套试样的位移应当是均匀线性拉长，并且不应损坏结构。设定和保持这种位移用于每次重复试验。所述试验重复7次用于每层12、14、16与18和套10。以力(磅)除以位移(英寸)计算弹性。通过8次试验的弹性计算求和并将和数除以8来计算8次试验的平均弹性。
在一些实施例中通过如下作法使套对佩戴者更舒适：将内层12和外盖18固定到仅与内层和盖的外周边相邻的有关中间层14、16上，由此囊24a、24b、24c不直接固定到内层和盖上。这种结构考虑到囊24a、24b和24c与内层12无关地运动，并且反之亦然。共同授予的美国专利申请No.11/299,568本文引入作为参考，该专利申请公开了一种旨在使用期间减少人的皮肤的磨损的实施例。
因此，当套10环绕佩戴者的肢体沿周边包扎时，内层12基本上与肢体的轮廓或形状相符，并当囊24a、24b、24c充气和放气和/或移动位置时将靠在佩戴者的肢体上保持基本上不动。如果囊的表面连续地摩擦肢体，则囊24a、24b、24c的运动不论在它们充气和放气还是在相对于肢体移动位置时都对病人可能引起磨损和其它不舒适。然而，通过仅在中间层14、16的外周边处被固定，内层12在囊24a、24b、24c与肢体之间产生缓冲，这防止对肢体的皮肤的磨损和其它摩擦。囊24a、24b、24c可以运动，且不引起内层12对皮肤的相应运动。
当介绍本发明各部分或其优选实施例(或多个)时，冠词“一”、“一种”、“该”和“所述”表示指有一个或多个部分。术语“包括”、“包含”和“具有”表示是内含的，并且意指除列出部分之外可能有另外的部分。
由于在不脱离本发明的范围情况下可以对上述构造、产品、及方法进行各种改变，所以这意味着，以上说明书中包含的和在附图中表示的所有内容都应视为举例说明性的，而不是限制性的。

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1.一种用于对佩戴者身体的一部分施加压迫治疗的装置，该装置包括：
第一和第二相对的囊层，这两个囊层沿着两个囊线彼此固定，以限定沿着装置的轴线彼此间隔开的第一和第二可充气囊；
连接段，其包括第一和第二囊层中的至少一个的一部分；该连接段在第一和第二可充气囊之间延伸，并将它们彼此连接；
减弱线，其在连接段中，横向于所述装置的轴线延伸，用于选择性地将可充气囊彼此分离；
叠置层，其与第一和第二囊层中的一个成相对关系，叠置层在减弱线附近不连续，以限定沿着减弱线延伸的叠置层的终端边缘界限，该终端边缘界限每个连接到减弱线的与另一个终端边缘界限相对的一侧上的第一和第二囊层中的至少一个上。
2.根据权利要求1所述的装置，其中，终端边缘界限在减弱线的相对侧上彼此间隔开。
3.根据权利要求2所述的装置，其中，叠置层包括第一和第二叠置层部分，这两个叠置层部分在横向于装置的轴线的方向上无论在何处都彼此间隔开。
4.根据权利要求1所述的装置，其中，叠置层的终端边缘界限沿着终端边缘界限固定到第一和第二囊层中的所述一个上。
5.根据权利要求4所述的装置，其还包括用于将空气输送到第一可充气囊的沿着连接部分延伸的管，其中，每个终端边缘界限沿着不延伸跨过管的断续焊接线而固定到第一和第二囊层中的所述一个上。
6.根据权利要求4所述的装置，其中，叠置层还沿着周边固定线固定到第一和第二囊层中的所述一个上，该周边固定线靠近叠置层的周边延伸，其中，在叠置层的周边内的叠置层的至少主要部分不固定到第一和第二两个囊层上。
7.根据权利要求6所述的装置，其中，周边固定线环绕叠置层的周边连续地延伸。
8.根据权利要求1所述的装置，其中，叠置层包括与第一囊层成相对关系的内衬。
9.根据权利要求8所述的装置，其还包括与第二囊层成相对关系的外盖，该外盖与减弱线相邻而不连续，以限定沿着减弱线延伸的外盖的终端边缘界限，该终端边缘界限每个都连接到减弱线的与另一个终端边缘界限相对的一侧上的第二囊层上。
10.根据权利要求8所述的装置，其还包括用于将空气输送到第一可充气囊的沿着连接部分延伸的管，其中，每个终端边缘界限沿着不延伸跨过管的断续焊接线连接到第二囊层上。
11.根据权利要求9所述的装置，其中，外盖的终端边缘界限在减弱线的相对侧上彼此间隔开。
12.根据权利要求11所述的装置，其中，外盖包括第一和第二外盖部分，这两个外盖部分在横向于装置的轴线的方向上无论在何处都彼此间隔开。
13.根据权利要求11所述的装置，其中，外盖的终端边缘界限沿着终端边缘界限固定到第二囊层上。
14.根据权利要求1所述的装置，其中，连接段包括第一和第二囊层二者的部分，其中，减弱线包括在第一和第二两个囊层中形成的穿孔线。
15.根据权利要求1所述的装置，其中，所述装置包括设定尺寸和定形以容纳佩戴者膝盖的膝盖开口，连接部分包括从包括第二囊的套的远侧段到包括第一囊的套的近侧段延伸的在膝盖开口的相对侧上包括第一和第二桥形件，其中，减弱线包括靠近第一桥形件与远侧段相交之处的第一减弱线、和靠近第二桥形件与远侧段相交之处的第二减弱线。
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CA2678343C (en) 2013-03-26
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