CN102036629B - 直肠排泄用具 - Google Patents
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Abstract
公开了一种直肠排泄用具,其包括在远端处具有用于将用具锚定到直肠上的可充气气囊的管状元件。该用具包括以下的一个或多个:(i)第一辅助腔管和第二辅助腔管,其与可充气气囊相关,用以提供联接到气囊上的独立的充气路径和压力监测路径;(ii)压力状态指示器,其由构造成用以响应于感测的压力而在第一与第二状态或形状之间翻转的机械元件所限定;以及(iii)可收缩的辅助腔管,其大于充气腔管且构造成用以容许冲洗流体进入。压力状态指示器也可在肠内排泄道中使用。
Description
发明领域
本发明涉及一种呈排泄管形式的直肠用具,其具有在使用中可插入直肠内的可充气气囊。本发明的另一方面涉及一种压力水平指示器,其用于指示直肠或肠内排泄道的可充气气囊内的压力水平。
发明背景
美国专利公布No.2005/054996和2005/137526描述了呈伸长管状元件形式的排泄物处理用具。各管状元件均包括在远端处的可充气气囊,用于将该远端锚定在佩戴者直肠的操作位置上。该管状元件包括主排泄通路和两个小尺寸的辅助腔管,这两个腔管彼此相似并结合到排泄通路的壁中。其中的一个腔管与气囊连通,用于在充气和放气期间使充气流体在气囊与充气端口之间经过。其中的另一腔管具有用于将冲洗流体从冲洗端口直接地注入直肠腔中的开口端。该管状元件在直径方面是可收缩的,以便于穿过肛门括约肌。US-A-2005/054996特别强调了小心地控制气囊中的充气压力的重要性,以提供在直肠中的良好锚定,同时仍确保气囊所接触的软组织中的正常血液灌流,以及避免软组织的压迫性坏死。在一种形式中,压力水平指示器用在充气腔管上,以便向临床医生提供重要的压力指示。压力水平指示器包括在充气端口附近联接到充气腔管上的单独的压力传感器,或结合到充气注射器中的压力指示器,或对充气注射器加载以用作压力稳定器和指示器的弹簧。相对于所用充气流体的体积,达到所期望的充气压力的点也是临床医生用来评估气囊对于佩戴者的直肠腔而言尺寸是否恰当的重要特征。如果充气压力阈值太快地达到,则这表示气囊过大;如果从未达到充气压力,则这表示气囊过小。
尽管上述公开申请并未明确描述,但这些申请所阐述的设计中也存在影响辅助腔管尺寸的多种约束。鉴于期望主管状元件在直径上可收缩以便于穿过肛门括约肌,故辅助腔管具有较小的不收缩形式,以容许在期望使气囊放气至最小尺寸时施加吸力强制地将充气流体从气囊中抽出。腔管的不收缩性质意味着腔管妨碍主管状元件的收缩。辅助腔管相对较小,以便最大限度地减小这种妨碍效果,且使主管状元件能够收缩至所期望的较小形式。
美国专利公布No.2008/0312614描述了一种用于排泄和收集来自于小肠的流体/粪便的回肠造口套件。该套件包括配备有两个气囊的气囊导管,其中,固定气囊在大肠中充气,而阻挡气囊在鲍安氏瓣后方的小肠中充气。各气囊均填充其所安置处的整个腔管。相对于所用充气流体的体积,在各气囊中达到所期望的充气压力的点是评估各气囊对于患者大肠和小肠而言尺寸是否恰当的重要特征。
期望的是,进一步提高这些直肠排泄用具的多用性和易用性。
发明概述
本发明的一方面提供了一种用于直肠排泄导管或肠内排泄道的充气气囊的压力水平指示器。压力水平指示器包括取决于感测的压力而在不同的第一物理状态与第二物理状态之间翻转的机械元件。该状态可为元件的不同形状。机械元件可具有三维形状,如圆顶形,其在非反转状态与反转状态之间翻转。在一种状态,圆顶像弹起的按钮一样凸出;在另一种状态,圆顶像沟谷或井一样凹陷。机械元件可形成塑料壳体的一体模制的部分。提供使其状态翻转的机械元件可提供对某一压力状态的可立即辨认和明确的指示,且还可使临床医生比从压力传感器的可变标度上读出测量值更容易和快捷地进行评估。机械元件还可比常规可变压力传感器更为紧凑,且/或重量更轻,且/或更为便宜地提供。本发明的此方面的压力水平指示器可结合为一次性用具的一部分,而没有任何显著的成本增加。例如,压力水平指示器可结合到用具的充气端口壳体中。
当感测的压力相对于作用于元件上的外部压力越过(超过或降低低于)阈值时,则机械元件可从第一状态翻转至第二状态。机械元件可构造成如果感测的压力沿相反的方向再越过阈值则翻转回第一状态,以便该元件总是提供对当前压力状态的指示。作为备选,机械元件可永久地保持在第二状态,以提供越过压力阈值的永久记录。
可提供在不同压力阈值下翻转的多个机械元件。例如,可提供两个机械元件,以便示出充气压力是否处于期望的充气范围。此外或作为备选,第一机械元件可指示已获得期望的充气压力以便使用具在直肠中达到所期望的锚定,以及第二机械元件可指示已获得期望的放气压力以便容许从直肠容易且安全地移除用具。
本发明的另一方面提供了一种直肠排泄用具,其包括用于插入直肠中的可充气气囊。该用具包括与可充气气囊连通的第一辅助腔管和第二辅助腔管。第一辅助腔管用作充气腔管。第二辅助腔管用作压力感测腔管,独立于充气腔管中的动态压降用来提供对气囊中充气压力的直接指示。
本发明的此方面出于以下认识:小尺寸的充气腔管可对充气流体的流动施加阻力,且在充气期间充气流体流入气囊或在放气期间流出气囊的同时形成动态压降。动态压降意味着充气端口处的压力测量结果并非总是准确地指示气囊中的压力。提供第二辅助腔管提供了对气囊中内部压力的直接感测,且使临床医生能够不受充气腔管中的任何动态压降影响而具有对该内部压力的准确指示。
在优选的形式中,至少第二腔管预先填充有充气流体。这在第二腔管填充有充气流体时最大限度地减小了气囊与机械元件之间的压降。
本发明的另一方面提供了直肠排泄用具的管状元件,该管状元件具有主排泄通路、至少一个不收缩(或不可收缩)的辅助腔管,以及至少一个收缩(或可收缩)的辅助腔管。至少在收缩辅助腔管处于扩张形状时,收缩辅助腔管优选为具有比不收缩辅助腔管具有更大的横截面积。不收缩辅助腔管可与提供在管状元件远端处的可充气气囊连通。收缩辅助腔管可与管状元件远端处的敞口空间直接或间接地连通。
本发明的此方面出于以下认识:尽管与可充气气囊相关的辅助腔管有利的是不收缩的而容许施加吸力,但对辅助腔管的冲洗有较少的约束。本发明的第三方面使相对较大的辅助腔管能够注入冲洗流体。除使冲洗较为容易外,腔管还可以更为多用的方式使用,例如,容许温度传感器或其它医疗装置插入直肠腔中而基本上不会干扰排泄。当从该腔管去除供送的冲洗流体或医疗装置时,腔管可收缩成较小的尺寸,以便提供较大的辅助腔管不会妨碍管状元件的期望的收缩性质。
鉴于另一方面,本发明提供了一种包括管状元件的直肠排泄用具,该管状元件在远端处具有用于将用具锚定在直肠中的可充气气囊。用具包括以下的一个或多个:(i)第一辅助腔管和第二辅助腔管,其与可充气气囊连通以提供联接到气囊上的独立的充气路径和压力监测路径;(ii)压力状态指示器,其由构造成用以响应于感测的压力在第一与第二状态或形状之间翻转的机械元件所限定;以及(iii)可收缩的辅助腔管,其大于充气腔管,且构造成用以容许冲洗流体或医疗装置经由可收缩的腔管进入用具的远端。
本发明另一方面为压力指示器或充气端口,其构造成用作充气流体的进入和排出点,以便控制美国专利公布No.2008/0312614中所示类型的肠内排泄道的各个可充气气囊的充气状态。
以上方面可组合使用,或以上方面中的任意两个可有选择地组合在一起,或任何方面都可独立于其它方面使用。尽管上文和权利要求以及以下说明中强调了认为很重要的特征,但申请人可试图主张保护本文所公开和/或附图中所示的构想的任何新颖特征,而不论是否已经对其进行了强调。
附图简述
图1为示出直肠排泄用具的第一实施例的示意性截面视图。
图2为沿图1中的线II-II的示意性截面视图。
图3为单独示出第一实施例的压力指示器或充气端口或包括一体式压力传感器的肠内排泄道的示意性透视图。
图4(a)为示出用于压力指示器/充气端口的模制机械元件的第一构型的示意性截面视图。
图4(b)示出了用于压力指示器/充气端口的模制机械元件的第一构型的翻转状态。
图5(a)为示出用于压力指示器/充气端口的模制机械元件的第二构型的示意性截面视图。
图5(b)示出了用于压力指示器/充气端口的模制元件的第二构型的翻转状态。
图6为示出包括多个状态指示器的压力指示器/充气端口的第二实施例的备选压力指示器的示意性透视图。
图7为本发明的第三实施例中的备选压力指示器/充气端口的示意图。
图8为直肠排泄用具的第四实施例的局部示意图。
优选实施例详述
相同的参考标号表示各实施例中的相似或等同的特征。对于直肠排泄管的附加构成细节可在上述美国专利公布No.2005/054996和2005/137526中找到,它们的内容通过引用并入到本文中。
参看图1和图2,直肠排泄用具10通常包括限定用于粪便通过的排泄通道14的挠性的、伸长管状元件12。元件12具有用于经由肛门插入佩戴者直肠中的远端16,以及用于联接到排泄物收集器(未示出)如袋囊上的近端18。通常,元件12为大约1.5m长,且具有大约23mm的外径。元件12在直径上可收缩至大约8mm,以便于穿过肛门括约肌。元件12通常由诸如硅树脂(或硅酮)的软塑料制成。元件12可设有附加的气味阻隔层或单独的气味阻隔套筒(未示出),以便阻碍恶臭流逸穿过排泄通道14的壁。
可充气气囊20提供在远端16处,用于将远端16锚定在直肠内。可充气气囊20为大致袖口或环面形状,且围绕远端16延伸。可充气气囊20可由在气囊20充气时可弹性地伸展的材料构成,但优选的是气囊20可预先形成为充气形状。这样预先形成能够在使用中使充气压力减小,因为气囊壁中有很少或没有反作用于所期望的充气的弹性返回力。
管状元件12包括分别与气囊20连通的第一辅助腔管22和第二辅助腔管24。腔管22,24可为大致相同的尺寸(例如,横截面积),或第二腔管24可小于第一腔管22。其中的一个腔管22,24,例如,第一腔管22,用作使充气流体在气囊20与充气端口26之间穿过的充气腔管,以便在期望时对气囊20充气或放气。另一腔管,例如,第二腔管24,用作压力感测腔管,以便独立于充气腔管22中的任何动态压降而提供对气囊20内的压力的直接指示,如下文所述。
第一辅助腔管22和第二辅助腔管24构造成在使用中大致为不收缩的,以便容许施加吸力来强制地抽出充气流体,且将气囊20完全放气至最小尺寸。这适用于弹性和预先形成这两种类型的气囊,但对于预先形成的类型尤其重要,因为气囊壁中没有弹性返回力趋于用来排出充气流体。为了总体上避免不收缩的辅助腔管22,24有损元件12的期望的收缩,第一腔管22和第二腔管24在尺寸上相对较小(例如,直径大约2mm或更小)。此种较小的直径尺寸可对腔管22,24中的大体积的充气流体流施加阻力,从而在气囊20充气或放气期间导致充气腔管22中的动态压降。动态压降形成气囊20内的流体压力PB与充气腔管22的充气端口端处看到的流体压力PIP之间的差异。这可使得充气或放气期间从充气腔管22所获得的压力测量结果不准确,或至少不明确,直到流体流动停止。然而,本实施例中提供的附加压力感测腔管24使得能够使用一定路径在气囊20内直接感测流体压力PB,该路径明显很少受到充气腔管22中的体积流动所造成的动态压降的影响。由于压力感测设备其自身基本上不会引起显著的体积流动,故在感测腔管24近端处的感测压力Ps为贯穿充气和放气过程中气囊20内的流体压力PB的更准确、稳定、明确和连续的表现。此外,由于两个辅助腔管22,24都具有不收缩的壁,故辅助腔管24还容许准确感测由于施加吸力以使气囊20放气而引起的气囊20中的较低压力。这使临床医生能够可靠地观察充气压力,以及观察充气压力达到某一水平的点以便评估气囊尺寸事实上是否适于佩戴者。至少第二辅助腔管24可预先填充有充气流体,以容许立即使用,而不需要排出任何空气,或额外填充充气流体以在使用前准备好用具。
在本实施例中,第一辅助腔管22和第二辅助腔管24在一起组合成共同的凸起30。凸起30为大致数字8形或″B″形。第一辅助腔管22和第二辅助腔管24可为管状元件12内部或外侧的独立腔管,但在优选形式中,其中的至少一个(且优选为两个)腔管22,24沿辅助腔管长度的很大一部分附接到管状元件12上,或与管状元件12一体地模制。
此外在本实施例中,感测腔管24通向包含或带有充气端口26的相同壳体32。壳体32还包括或带有联接到辅助腔管22,24上的第一和第二节点33。在一种形式中,壳体32可包括或带有附加压力感测端口(未示出),其用于容许连接外部压力传感器(未示出)以便经由感测腔管24监测所感测的压力。然而,在优选的形式中,壳体32包括响应于经由感测腔管24所感测的压力的一体式压力指示器34。
参看图3至图5,压力(或压力状态)指示器34包括机械元件36,该机械元件36取决于感测的压力而在不同的第一物理状态与第二物理状态(例如,形状)之间翻转。在所示的形式中,机械元件36具有反转的三维形状,如圆顶形,其反转或非反转的状态指示压力水平状态。在一种状态,圆顶像弹起的按钮一样凸出;在另一种状态,圆顶像沟谷或井一样凹陷。机械元件36为壳体32的一体模制部分。当感测的压力相对于作用于元件上的外部压力越过(超过或降低低于)压力阈值时,机械元件36可从第一状态翻转至第二状态。图4(a)示出了模制成第一凹陷状态的机械元件36的第一构型,以及图(4b)示出了当元件36后方的压力P+超过环境外部压力一定的阈值时第一构型翻转到第二凸出状态的机械元件36。图5(a)示出了模制为第一凸出状态的机械元件36的备选第二构型,以及图5(b)示出了在元件后方的压力P-降低至低于环境外部压力一定阈值时第二构型翻转到第二凹陷状态的机械元件36。
机械元件36翻转所处的压力(差异)可由材料性质、三维形状的几何结构以及元件36的厚度和回弹性的设计而设定。此外,辅助加强构件(未示出)可用于加强元件36和提供附加的控制。机械元件36可构造成如果感测的压力沿相反的方向再越过阈值则翻转回第一状态,以便该元件36总是提供对当前压力状态的指示。作为备选,机械元件36可构造成永久地保持在第二状态,从而提供越过压力阈值的永久记录。
如图3中最佳示出的那样,在制造期间,壳体32模制成具有内腔,该内腔在一侧上具有临时开口38,模芯收容于该临时开口38中用于模制机械元件36的内部形状。为了完成壳体32,临时开口38随后塞住或密封封闭(例如,通过焊接或粘合)。
使用机械元件36通过在不同状态(例如,形状)之间翻转来指示压力可提供对某一压力状态的立即辨认和明确指示,且还可使临床医生比必须从压力传感器的可变标度中读出测量值更容易且快捷地评估。机械元件36可使压力指示器34能够比常规可变压力传感器更紧凑、重量更轻和/或更便宜中的任何一种。因此,压力指示器34适于包括为一次性直肠排泄用具10的一体式部分。具有机械元件36的压力(或压力状态)指示器34还可用于具有可充气气囊的肠内排泄或排泄用具装置,例如参见美国专利公布No.2008/0312614。
在图1至图5的实施例中,压力指示器34包括单个机械元件36,该机械元件36构造成用以代表单个压力状态,例如,已经达到的预定充气压力水平(使用图4(a)和图4(b)的第一构型)。图6中所示的第二实施例提供两个或多个机械元件36a,36b等,其分别构造成用以指示分别不同的压力状态。例如,可提供第一机械元件36a和第二机械元件36b用以示出充气压力是否处于所期望的充气范围内,使用一个机械元件36a指示其下限,而由另一机械元件36b指示其较高水平。机械元件36a和36b两者可均为第一构型(图4(a)和图4(b))。这可使临床医生能够确定充气压力是否处在最佳工作范围内,即使该范围相对较窄。此外或作为备选,第一机械元件36a可指示已经获得了所期望的充气压力,以便使用具在直肠中实现所期望的锚定,以及另一机械元件(例如,36b或36c)可指示在气囊20中已经获得所期望的放气或吸入压力,确保了气囊20处于其完全收缩形式,从而容许将用具10简单且安全地从直肠内移除。该种另一元件可为第二构型(图5(a)和图5(b))。
再参看图1和图2,管状元件12还包括收缩的辅助腔管50。收缩的腔管50具有的横截面积(当处于由虚线所示的扩张状态时)大于不收缩的第一腔管22和第二腔管24中的各个的横截面积。在一种形式中,收缩腔管50具有处在大约2mm至5mm之间的扩张的横截面直径。收缩腔管50与管状元件12远端16处的开口直接或间接地连通。在使用中,收缩腔50容许将冲洗流体经由腔管50容易地注入直肠腔中。腔管50的较大尺寸容许例如比现有技术中使用的相对较小尺寸的冲洗腔管更低的压力下使冲洗流体更容易地流动。腔管50的较大尺寸还容许医疗装置(例如,温度传感器)容易地插入直肠腔中,这在使用现有技术的相对较小的辅助腔管的情况下是不可能的,至少是不容易实施的。当移除冲洗流体源或医疗装置时,腔管50可收缩至其紧凑状态。腔管50的壁有回弹性以利用回弹返回力使腔管50收缩至其紧凑状态,或腔管50的壁为挠性的而容许在腔管50受到压缩时收缩。因此,提供的腔管50不会有损管状元件12的期望的收缩,在腔管50处于其正常收缩或紧凑状态下时,其基本上也不会妨碍经由管状元件12内的排泄通道14排泄流出物。
应当认识到的是,构想(i)收缩腔管50、(ii)与可充气气囊20连通的双腔管22,24以及(iii)压力指示器34中的任何一种都可有选择地与任何其它构想组合或独立于任何其它构想使用。然而,由于组合越多的构想,则导致更多的协同。
参看图7,压力指示器60示出为类似于先前所述的压力指示器34,但压力指示器60不与专用感测腔管连通,而作为替代的是响应于充气腔管22中的充气压力。压力指示器60结合到壳体32中,且与端口26和腔管22直接连通。该实施例对于没有独立于充气腔管22的专用感测腔管的管状元件现有设计而言,可用于实现备选的压力指示器,其中,管状元件的现有设计例如有上述美国专利公布No.2005/054996和2005/137526中所述的用具。
参看图8,第四实施例示出为实现了与远端16连通的收缩辅助腔管50以及与气囊20连通的两个不收缩腔管22,24。备选的压力传感器70提供为联接到感测腔管24上。压力传感器70包括壳体72,该壳体72包含有弹簧76偏压的柱塞74。壳体72的至少一部分是透明的,以容许观察柱塞74的位置,该位置直接表示经由感测腔管24所感测的气囊压力。
前述说明示出了本发明的优选实施例。在不脱离要求得到专利保护的本发明范围的情况下可使用多种等效布置、修改和改进。
Claims (10)
1.一种直肠排泄用具,包括:
管状元件,其限定用于传送来自所述直肠的废物的排泄通路;
可充气气囊,其位于所述管状元件的第一远端处用于保持所述直肠中的用具;
与所述可充气气囊连通的不充气的辅助腔管;以及
压力指示器,其联接到所述辅助腔管上用于指示所述气囊内的压力水平,所述压力指示器包括第一机械元件,所述第一机械元件具有三维可变形形状且构造成取决于所感测的压力是否为:(i)达到操作水平的气囊充气压力;或者(ii)降低至预定充气水平以下的气囊充气压力而在第一物理形状与第二物理形状之间翻转。
2.根据权利要求1所述的直肠排泄用具,其特征在于,所述三维形状为可反转的圆顶。
3.根据权利要求1所述的直肠排泄用具,其特征在于,所述直肠用具还包括联接到所述辅助腔管上的第二机械元件,所述第二机械元件构造成用以在压力不同于与所述第一机械元件相关的压力下在第一物理状态与第二物理状态之间翻转。
4.一种直肠排泄用具,包括:
管状元件,其限定用于传送来自所述直肠的废物的排泄通路;
可充气气囊,其位于所述管状元件的远端处用于保持所述直肠中的用具;
第一辅助腔管,其与所述可充气气囊连通,用于使充气流体在所述气囊与充气端口之间穿过而容许所述气囊充气和放气;以及
第二辅助腔管,其与所述可充气气囊连通,使得能够独立于所述第一辅助腔管中的动态压降而直接感测所述气囊中的压力,
压力指示器,其联接到所述辅助腔管上用于指示所述气囊内的压力水平,所述压力指示器包括第一机械元件,所述第一机械元件具有三维可变形形状且构造成取决于所感测的压力状态是否为:(i)达到操作水平的气囊充气压力;或者(ii)降低至预定充气水平以下的气囊充气压力而在第一物理形状与第二物理形状之间翻转。
5.根据权利要求4所述的直肠排泄用具,其特征在于,所述管状元件构造成用以容许所述管状元件收缩,以及所述第一辅助腔管和所述第二辅助腔管构造成大致为不收缩的。
6.根据权利要求4所述的直肠排泄用具,其特征在于,所述第一辅助腔管和所述第二辅助腔管中的各个均具有大约2mm或更小的直径。
7.根据权利要求4所述的直肠排泄用具,其特征在于,所述压力状态指示器为所述用具的组成部分。
8.根据权利要求4所述的直肠排泄用具,其特征在于,所述第一辅助腔管和所述第二辅助腔管大致并排地设置在共同的凸起中。
9.根据权利要求4所述的直肠排泄用具,其特征在于,所述第一辅助腔管和所述第二辅助腔管附接到所述排泄管上,或与所述排泄管一体地模制。
10.根据权利要求4所述的直肠排泄用具,其特征在于,所述辅助腔管中的至少一个预先填充有充气流体。
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CN102036629A (zh) | 2011-04-27 |
MX348673B (es) | 2017-06-23 |
EP2278945A1 (en) | 2011-02-02 |
JP5911624B2 (ja) | 2016-04-27 |
JP5730755B2 (ja) | 2015-06-10 |
NZ718101A (en) | 2017-07-28 |
EP2278945B1 (en) | 2013-12-18 |
EP2278945A4 (en) | 2011-09-07 |
US20200030521A1 (en) | 2020-01-30 |
RU2010149058A (ru) | 2012-06-10 |
NZ629430A (en) | 2016-07-29 |
US20160331890A1 (en) | 2016-11-17 |
JP2011519629A (ja) | 2011-07-14 |
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