CN113164673A - 医疗输注*** - Google Patents
医疗输注*** Download PDFInfo
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- CN113164673A CN113164673A CN201980070180.1A CN201980070180A CN113164673A CN 113164673 A CN113164673 A CN 113164673A CN 201980070180 A CN201980070180 A CN 201980070180A CN 113164673 A CN113164673 A CN 113164673A
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Abstract
本发明涉及一种具有柔性导管的输注***,所述柔性导管具有远端区域和近端区域,所述远端区域用于连接到输注容器,所述近端区域具有患者连接端口。根据本发明,所述患者连接端口具有封闭装置,所述封闭装置是透气和液密的。在医疗领域用于静脉内给药的用途。
Description
技术领域
本发明涉及一种具有软管的医疗输注***,该软管具有远端区域和近端区域,该远端区域用于连接到输注容器,该近端区域具有患者连接端口。
背景技术
US5,954,485A公开了一种用于医疗输注***的输注泵的自由流动保护装置,其中,该自由流动保护装置防止输注液体自由地流动到患者连接端口。该装置是医疗输注***的一部分,其中,来自输注容器的输注液体通过软管流到患者连接端口。在输注***的操作期间,患者连接端口连接到患者侧的导管。在输注***的操作期间,如果输注容器悬挂在患者连接端口上方并且患者连接端口连接到患者的导管,那么在没有额外措施的情况下,输注液体自由地流入患者的静脉,直到患者的血压和输注***的液体静压彼此平衡。这种自由流动可能是不利的,因为它可能导致患者的过度用药。而且,进入患者血流的软管中的气泡可能具有不期望的后果。US5,954,485公开了一种防止输注液体的这种自由流动的装置。该装置包括夹紧区域,该夹紧区域根据杠杆的位置来关闭或释放软管。该装置被分配给输注泵,该输注泵控制输注液体通过软管的流动。
发明内容
本发明的目的是提供一种医疗输注***,该医疗输注***是在开头时提到的类型,并且允许以安全且无污染的方式进行输注***的第一次填充。
对于医疗输注***,该目的通过以下事实实现:患者连接端口设置有封闭装置,该封闭装置具有透气且液密设计。根据本发明的解决方案允许软管的第一次填充和患者连接端口到患者接入部(特别是患者侧的导管)的连接,而不存在使用者或患者在患者连接端口的区域中的污染的任何可能性。封闭装置的透气性确保在第一次填充期间在软管中产生的气泡能够在患者连接端口的区域中逸出。同时,液密设计确保在第一次填充期间没有输注液体能够在患者连接端口的区域中逸出。优选地,封闭装置被设计成使得其仅在输注***被附接成准备好在患者侧操作时才有效,以便不妨碍输注液体到患者接入部(patientaccess)的输注,所述输注是在“准备好操作”的附接之后期望进行的,特别是经由导管进入患者的静脉。术语“远端区域”和“近端区域”是相对于患者而言的,也就是说,输注***的患者连接端口靠近患者,即近侧的,而用于连接到输注容器的端部区域远离患者并且因此相对于软管是远侧的。
在本发明的一个实施例中,封闭装置具有封闭盖,该封闭盖以压力密封的方式保持在患者连接端口上。这确保了封闭盖不会由于输注泵产生的输送压力而意外地从患者连接端口脱离。
在本发明的另一实施例中,患者连接端口或封闭盖具有封闭膜,该封闭膜封闭患者连接端口,使得患者连接端口对于空气是可透过的并排斥输注溶液。优选地,在将患者连接端口连接到患者接入部期间,具有封闭膜的封闭盖保持在患者连接端口上。替代地,封闭膜连接到患者连接端口,使得即使在移除封闭盖之后封闭膜也保留在患者连接端口的相应贯通开口的区域中。有利地,一旦患者连接端口连接到患者接入部,封闭膜就被自动地刺穿。
在本发明的另一实施例中,远端区域具有滴注腔室,该滴注腔室具有穿刺芯轴。穿刺芯轴设置成将滴注腔室连接到输注容器的封闭塞。
在本发明的另一实施例中,软管被分配有通流控制装置,特别是辊夹的形式。软管、滴注腔室、辊夹和患者连接端口形成用于医疗输注***的传送***,以便将输注液体从输注容器传输到患者接入部。
在本发明的另一实施例中,软管被分配有止回阀,该止回阀具有大于输注***的液体静压的打开压力,在组装的操作状态下,该止回阀位于软管的近端区域中。输注***的液体静压起因于填充有输注液体的输注容器位于患者接入部上方的高度处,优选地在患者接入部上方大约1 m。止回阀用作自由流动保护,这是因为只要软管内只有输注***的液体静压有效,止回阀就保持软管关闭。如果输注容器位于患者接入部上方大约1 m处,则软管内的液体静压大约是100 mbar。因此,止回阀的打开压力有利地为约150 mbar。
在本发明的另一实施例中,软管被分配有输注泵,该输注泵在操作期间对将要被输送的输注液体施加大于止回阀的打开压力的压力。优选地,在操作期间,输注泵将200mbar的输送压力施加至将要被输送的输注液体,使得输注泵的操作打开止回阀并且允许输注液体流动通过软管。止回阀有利地在输注泵和患者连接端口之间的区域中被分配到软管。
在本发明的另一实施例中,封闭膜在水窜压力(water breakthrough pressure)下打开,该水窜压力大于输注泵的输送压力。这确保在软管的第一次填充期间,即使在输注泵已经开始其操作时,患者连接端口也保持关闭。这允许以无气泡的方式完成软管的第一次填充,使得当患者连接端口连接至患者接入部时,输注液体可被供给到患者的静脉中而不会污染患者连接端口或患者接入部。在约200 mbar的输注泵的输送压力下,封闭膜的水窜压力为至少250 mbar。
在本发明的另一实施例中,在输注泵的输出侧的软管被分配有压力传感器,该压力传感器检测超过输注泵的输送压力的压力升高。当软管的第一次填充结束并且输注泵继续在患者连接端口的方向上输送输注液体时,出现超过输送压力的压力升高,压力传感器检测到该超过输送压力的压力升高。
在本发明的另一实施例中,压力传感器被附接到信号装置,使得一旦检测到超过输送压力的压力升高,信号装置就发出信号。信号装置优选地发射光信号和/或声信号。该信号用于通知使用者第一次填充过程结束,并且输注泵的驱动器可以被关断。
在本发明的另一实施例中,压力传感器被附接到输注泵的控制设备,使得当检测到超过输送压力的压力升高时,输注泵的驱动器被关断和/或信号设备被致动以生成光信号和/或声信号。这样,一旦第一次填充过程结束,就以自动的方式关断输注泵。替代地或附加地,当检测到200 mbar的压力时,压力传感器发出相应的信号,控制装置处理该信号和/或该信号对于使用者来说是光学地和/或声学地可辨别的。
附图说明
本发明的其它优点和特征将从权利要求书和对本发明优选示例性实施例的以下描述中变得清楚,该优选示例性实施例在附图中示出。
单个附图是根据本发明的医疗输注***的实施例的示意性表示。
具体实施方式
输注***1具有在输注容器2和患者接入部(未示出)之间的传送***。医疗输注***1用于将输注液体从输注容器2传输到患者接入部,以便将药物或营养溶液施用给患者。所提供的患者接入部具体是静脉内患者接入部,输注***1能够连接到该静脉内患者接入部。
医疗输注***1具有柔性软管6,其有利地是透明的。软管6在远端区域牢固地连接到滴注腔室5,滴注腔室5在远侧设置有穿刺芯轴4。当输注***1处于准备好操作的组装状态时,穿刺芯轴4已经通过压配合接合而***到输注容器2的下侧的区域中的弹性封闭塞3中。穿刺芯轴4具有至少一个通道,该至少一个通道伸入到输注容器2的内部,并且来自输注容器2的输注液体通过该至少一个通道传输到滴注腔室5中并从那里进入软管6中。在准备好操作的组装状中下,输注容器2悬挂在固定位置,特别是悬挂在支架上。支架有利地设置有滚轮,以便能够在地板表面上移动输注容器2,包括输注***1。
在输注***1的流动方向上,滴注腔室5后面是辊夹7,该辊夹7设置成手动地控制输注液体通过软管6的流动。输注***1还被分配有止回阀9(下面将更详细地描述),并且在软管6的近端区域处被分配有患者连接端口10。患者连接端口10被封闭盖11关闭。
在准备好操作的组装状态下,软管6被附接到输注泵8,该输注泵8设置有驱动器(未详细示出),以便机械地作用在软管6的护套(jacket)上,并且由此通过软管6传输输注液体。为此目的,软管6以本身基本上已知的方式放置到输注泵8的相应接收区域中,并且固定在该接收区域中。
最后,在输注泵8的输出侧,软管6被分配有压力传感器12,压力传感器12被附接到控制装置S(下面更详细地描述)。
以未详细示出的方式,患者连接端口10设置有封闭膜,该封闭膜关闭患者连接端口,使得后者对于空气是可透过的并且排斥输注溶液,也就是说是液密的。封闭膜被直接分配给患者连接端口10的贯通开口或者被分配给封闭盖11。在两种情况下,封闭膜用于以液密但同时允许空气通过的方式关闭输注***1的近端,并因此关闭软管6。如果将封闭膜分配给封闭盖11,则在将患者连接端口10连接到患者接入部时,封闭盖优选地保持在患者连接端口10上,以便在连接时自动地实现封闭膜的分离,而不会在患者连接端口10和患者接入部之间的连接部位处发生输注液体的逸出。患者连接端口10和患者接入部优选地设置有互补的鲁尔锁连接器。如果封闭膜直接分配给患者连接端口10,则封闭盖11可从患者连接端口10移除,而输注液体不能从患者连接端口10逸出。这是因为封闭膜继续封闭患者连接端口10,直到患者连接端口10借助于相应的鲁尔锁连接而牢固地连接到患者接入部。在连接期间,有利地,以一些其它方式刺穿或切开封闭膜,其结果是使得输注液体能够流动。封闭膜的透气性确保当输注***1被第一次填充时,气泡能通过软管6到达患者连接端口10并能在患者连接端口10处逸出,使得允许以无气泡的方式第一次填充输注液体。
为了将输注***1设置成操作状态,将穿刺芯轴4引入输注容器2的封闭塞3中。输注容器2已经悬挂在高度H处的固定位置,该高度H优选地高于患者接入部约1 m。将穿刺芯轴4从下方压入封闭塞3中,直到输注液体能够通过穿刺芯轴4的通道流入滴注腔室5。打开辊夹7。将软管6安装在设置有电驱动器的输注泵8的区域中。
止回阀9具有大于由悬挂的输注容器2和患者接入部(即患者连接端口10)之间的高度差引起的液体静压的打开压力。因此,只要输注泵8未被启动,止回阀9就关闭输注泵8和患者连接端口10之间的区域中的软管6。止回阀9限定了自由流动保护装置。然而,一旦输注泵8被启动,止回阀9的打开压力低于输注泵8的输送压力。因此,在启动输注泵8之后,由于输注液体的输送压力随之在软管6中升高,止回阀9打开,使得输注液体被输送直到患者连接端口10。患者连接端口10被封闭膜关闭。任何气泡也与输注液体一起在患者连接端口10的方向上被传输。由于封闭膜的透气性,相应的空气能在患者连接端口10的区域中逸出到环境中。同时,封闭膜被设计成排斥输注溶液,使得输注溶液在患者连接端口10的封闭膜的区域中积聚。当通过输注泵8的操作进一步输送输注液体时,软管6中的压力因此必然升高。压力的相应升高由设置在输注泵8的输出侧的压力传感器12监测。一旦软管内的压力升高到高于输注泵8的正常输送压力,压力传感器12就向控制装置S发出信号,控制装置S然后致动声信号和/或光信号发生器(未示出)和/或关断输注泵8的驱动器。如果仅致动声信号和/或光信号发生器,则使用者(特别是医院人员)必须根据相应信号的检测来关断输注泵8的驱动器。如果控制装置S直接致动输注泵8的驱动器,则当检测到相应的压力升高时,输注泵8的驱动器能被自动地关断。
如果高度差H为1 m,则输注***1内的液体静压为100 mbar。止回阀9具有大约150mbar的打开压力。由输注泵8的启动而产生的输送压力优选地大于150 mbar,并且有利地最大为200 mbar。压力传感器12有利地被设计成使得在大于200 mbar的压力下,它将相应的信号发送到控制装置S。在以上所述的值下,则封闭膜的水窜压力有利地为至少250 mbar。
因此确保了安全地并且以无气泡的方式进行输注***1的第一次填充。现在,患者连接端口10可以连接到患者接入部,其结果是封闭膜打开并且使得输注液体能够流动到患者接入部。
Claims (12)
1.一种具有软管(6)的医疗输注***(1),所述软管(6)具有远端区域和近端区域,所述远端区域用于连接到输注容器(2),所述近端区域具有患者连接端口(10),其特征在于,所述患者连接端口(10)设置有封闭装置,所述封闭装置具有透气且液密设计。
2.根据权利要求1所述的医疗输注***,其特征在于,所述封闭装置具有封闭盖(11),所述封闭盖(11)以压力密封的方式保持在所述患者连接端口(10)上。
3.根据权利要求1或2所述的医疗输注***,其特征在于,所述患者连接端口(10)或所述封闭盖(11)具有封闭膜,所述封闭膜关闭所述患者连接端口(10),使得所述患者连接端口(10)对于空气是可透过的并且排斥输注溶液。
4.根据前述权利要求中任一项所述的医疗输注***,其特征在于,所述远端区域具有滴注腔室(5),所述滴注腔室(5)具有穿刺芯轴(4)。
5.根据前述权利要求中任一项所述的医疗输注***,其特征在于,所述软管(6)被分配有通流控制装置,特别是辊夹(7)的形式的通流控制装置。
6.根据前述权利要求中任一项所述的医疗输注***,其特征在于,所述软管(6)被分配有止回阀(9),所述止回阀(9)具有大于所述输注***(1)的液体静压的打开压力,在所述输注***(1)的组装的操作状态下,所述止回阀(9)位于所述软管(6)的近端区域中。
7.根据权利要求6所述的医疗输注***,其特征在于,所述软管(6)被分配有输注泵(8),所述输注泵(8)在操作期间对将要被输送的输注液体施加大于所述止回阀(9)的打开压力的压力。
8.根据前述权利要求中任一项所述的医疗输注***,其特征在于,所述封闭膜在水窜压力下打开,所述水窜压力大于所述输注泵(8)的输送压力。
9.根据权利要求7和8中任一项所述的医疗输注***,其特征在于,在所述输注泵(8)的输出侧处,所述软管(6)被分配有压力传感器(12),所述压力传感器(12)检测超过所述输注泵(8)的输送压力的压力升高。
10.根据权利要求9所述的医疗输注***,其特征在于,所述压力传感器(12)被附接到信号装置,使得一旦检测到超过所述输送压力的压力升高,所述信号装置就发射信号。
11.根据权利要求10所述的医疗输注***,其特征在于,所述信号装置设置成发射光信号和/或声信号。
12.根据权利要求9至11中任一项所述的医疗输注***,其特征在于,所述压力传感器(12)被附接到所述输注泵(8)的控制装置(S),使得当检测到超过所述输送压力的压力升高时,所述输注泵(8)的驱动器被关断和/或所述信号装置被致动以产生光信号和/或声信号。
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DE102018214249.1A DE102018214249A1 (de) | 2018-08-23 | 2018-08-23 | Medizinisches Infusionssystem |
PCT/EP2019/067624 WO2020038634A1 (de) | 2018-08-23 | 2019-07-01 | Medizinisches infusionssystem |
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DE102018214249A1 (de) | 2020-02-27 |
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