CN1152720C - 一种具有用于在压力下分配液体的可膨胀液囊的移动式泵 - Google Patents
一种具有用于在压力下分配液体的可膨胀液囊的移动式泵 Download PDFInfo
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Abstract
在预定流量压力下分配液体的移动式泵(10)包括具有第一个和第二个端盖(14、16)的外壳(12),两个端盖装在外壳(12)上并密封外壳(12)。每个端盖(14、16)上有孔(18、20)。外壳(12)装载可加压液囊(22)以便容纳和输送液体。处于未膨胀状态和膨胀状态之间的液囊(22)可膨胀。液囊(22)有自由端(30)和固定端,前者限定与第二个端盖孔(20)相连通的液囊开口,后者限定与第一个端盖孔(18)相连通的开口。外壳(12)装载挠性管(40),挠性管(40)在液囊自由端(30)和第二个端盖孔(20)之间延伸并与它们相连通。移动式泵(10)有位于挠性管(40)和液囊(22)之间的连接件(32)以显示移动式泵(10)中的液体容积。当液囊(22)在膨胀状态和未膨胀状态之间变化时连接件(32)在外壳(12)内纵向移动显示移动式泵(10)中的液体容积。移动式泵(10)包括在第二个端盖(16)上的注液口(20)和从第一个端盖孔(18)延伸以便给患者输送液体的管路(50)。
Description
技术领域
本发明涉及封闭的移动式泵。特别是本发明涉及具有可膨胀或可耐压液囊的封闭的移动式泵以贮存和输送给患者的液体。
背景技术
移动式泵或输注筒的技术众所周知。这样的装置用于在预定时间段内以大体恒定的液体流量给患者输注预定量的液体药物。一种已知泵包括一个筒形的、弹性的、可加压的液囊,其内有要输注的液体。该液囊受到其内贮存液体的压力。该泵包括外壳、固定在外壳一端的塞及塞上的通孔。该液囊的一端封装在塞上,液囊的腔与塞的孔相连通。该泵包括管路,例如与塞孔连接的管路,它限定输液管路以便从液囊将液体输送到患者的输注部位。
位于输液管路中的流量调节器允许液体以预定流量从液囊通过输液管路输送给(例如)患者。该流量调节器或节流器有毛细管。
该泵包括一个固定在液囊自由端的“浮动”的或活动的盖或指示件。根据液囊中的液体容积指示件在外壳内纵向“浮动”或活动。指示件包括管路、位于管路中的单向阀及注入口或注液口,通过该注液口向液囊注液。该注液口和管路及液囊相连通。
为了注满液囊,需要压紧外壳的两端或使外壳的两端向外壳中间弯曲以控制指示件并将输注装置(例如灌注器)插入外壳。然后使该灌注器与注液口连接,液体就从灌注器注入液囊。该灌注器与注液口的连接通常采用螺纹连接,其形成灌注器与注液口之间的密封。当注满液囊时,允许指示件移动以容纳膨胀的液囊。
而现有的泵工作时要达到期望的良好效果,还有很多不利因素。首先,由于指示件的浮动特性液囊的外面基本上是向大气层敞开的。这样,万一液囊破裂,液囊中的液体就会流入外壳内。万一液囊破裂,装在外壳上的端盖会使液体留在外壳内。可是,端盖通常与外壳分开包装,如果外壳上的端盖安装得不合适,万一液囊破裂就会导致液体从外壳中漏出。
此外,因为必须通过筒壁控制指示件,指示件的“浮动”性质可能使注满输注装置常常很困难。因为指示件“浮动”当灌注器拧在注入口上时液囊会被扭曲。很明显,扭曲弹性液囊会削弱弹性材料,这样就加大了液囊破裂的可能性。此外,相信已遇到的问题是灌注移动式泵期间液体素流的结果。特别是当液体“突破”单向阀时,流动阻力引起液体紊流,液体紊流又导致液体中夹杂着空气。液体中所夹杂的空气在液体中形成微小气泡。已注意到这些微小气泡会在节流器毛细管中积聚。熟悉本领域的技术人员认识到微小气泡积聚可能导致通过毛细管液流的阻塞。
发明内容
因此,仍需要充分密封输注液囊的移动式泵,其便于注满贮存液囊并将液囊破裂的可能性降至最低。本发明的目的在于提供一种移动式泵装置,这样的装置容易用在标准的医疗器械上,并减少或解决现有移动式泵遇到的灌注问题和流量受限制问题。
本发明提供一种具有一外壳和包含在所述外壳内的用于在压力下分配液体的可膨胀液囊的移动式泵,其中所述液囊的内部可通过所述液囊的一移动自由端的注射而被注液,所述移动式泵包括:所述外壳;其具有位于所述外壳之上并密封该外壳的第一和第二个固定端盖,第一个端盖上具有形成在其中用于分配所述液体的孔;所述第二端盖具有一进口,所述可膨胀液囊限定了一内贮存的容积,所述液囊由所述外壳所装载并且在未膨胀状态和已膨胀状态之间是可膨胀的,所述液囊具有一限定与所述第一端盖流动连通的孔,并且其特征在于:所述液囊还包括限定一注液开口的所述自由端,和在所述注液开口和所述进口之间延伸的一绕性管,从而通过所述液囊自由端开口与所述液囊的内部建立了流体连通。
在预定流量压力下分配液体的移动式泵包括一个外壳,它具有位于该外壳上并密封该外壳的第一个和第二个固定端盖。每个端盖上有孔。该外壳装载限定内贮存容积的可加压液囊,以便容纳和分配液体。
处于未膨胀状态和膨胀状态之间的液囊可膨胀。该液囊具有自由端和固定端,该自由端限定与第二个端盖孔相流体连通的液囊开口,该固定端限定与第一个端盖孔相流体连通的液囊开口。
该外壳装载的一段挠性管,该挠性管在液囊的自由端开口和向液囊注液的开口之间延伸并与液囊的自由端开口和第二个端盖孔流体连通。
在优选实施例中,移动式泵包括位于挠性管和液囊之间的连接件。当液囊在膨胀状态和未膨胀状态之间变化时该连接件可在外壳内纵向移动。在最佳的实施例中,外壳用透明的或半透明的材料制成,外壳上有标记。连接件最好又是指示件且其上有标记,连接件和外壳上的标记共同配合显示移动式泵中液体的容积。
移动式泵具有在第二个端盖孔形成的注入口或注液口,该口与挠性管和液囊相连通。在优选实施例中,注液口为凹型Luer接口,移动式泵具有形成凸型Luer接口的保护盖,以便与注液口相配合。
移动式泵具有与液囊相连通并从第一个端盖孔伸出的管路。该管路最好有流量调节器。
移动式泵包括至少一个位于其内的阀,以允许液体流入液囊并阻止液体从液囊回流。该阀最好位于伸进可膨胀液囊的指示件上。在本实施例中,该阀为鸭嘴形阀。
为了容纳液囊膨胀的容积,移动式泵至少在端盖其中之一上有一个排气孔。该排气孔的形状允许空气出入以使外壳内压力保持在一个大气压左右。在最佳的实施例中,排气孔用疏水性材料盖住,疏水性材料允许空气或气体通过却阻止液体通过。
本发明的其它特点和优点将在下面的详细描述、附图以及所附权利要求中见到。
附图说明
图1是体现本发明原理的封闭的移动式泵的侧视图,所示移动式泵中的液囊处于未膨胀状态;
图2所示为图1的移动式泵,其中的液囊处于膨胀状态;
图3是图2移动式泵的横截面图,所示移动式泵带有与其连接的管路和流量调节器。
具体实施方式
本发明可以有各种形式的实施,附图所示及下文所描述的此优选实施例是作为本发明的一个例子,而不是将本发明局限于附图所示特定实施例。
现在参见附图,特别是图1所示为体现本发明原理的移动式泵10。移动式泵10包括主体部分或外壳12和分别密封外壳12两端的第一个端盖14和第二个端盖16。外壳12、第一个端盖14和第二个端盖16形成壳体13,壳体13确定了内腔15。外壳12最好用透明的或半透明的塑料材料制成。第一个端盖14和第二个端盖16分别有孔18、20。一个可膨胀的液囊(或称贮液囊)22位于内腔15中,并与端盖孔其中之一18的固定端24固定连接。可膨胀的液囊22有内贮存容积26,在未膨胀状态(如图1所示)基本上确定标号为28的腔。腔28或内贮存容积26与端盖14的孔18内部连通,液囊22与端盖14固定连接。对本说明书来说,该端盖称为第一个端盖14。相反地,对面端盖称为第二个端盖16。
液囊22的自由端30装在“浮动”件或称活动件32上,如同图示连接件或称指示件32。“浮动”件32有开口34,可膨胀的液囊22与开口34连接,腔28或内贮存容积26与开口34内部连通。如图所示,指示件32上有标记36,其与外壳12上的标记38结合,可确定泵10中液体的容积L。
至少一段或一部分挠性管40在指示件32和开口0之间伸长,管40的开口0用来注满液囊22。开口0最好与第二个端盖孔20的注入口39相连通。挠性管40最好既与穿过指示件32的开口34相连通又与第二个端盖16上的孔20相连通。此结构基本上形成了隔离的液体贮存和液体输送回路,液体从第二个端盖16的孔20流入挠性管40,通过指示件32和液囊22,从第一个端盖14的孔18流出。管40有相当小的内径以便输液后移动式泵中可能残留的液体量降至最少。小直径管也减少灌注移动式泵10所需的时间(或使灌注移动式泵10所需的时间降至最小)。可是,正如本说明书中更详细讨论的,管40中最少量的空气(大约0.50ml)增强了移动式泵10的工作。
正如从图1和图2中明显地看到的那样,挠性管40使液囊22能膨胀、收缩。在优选实施例中,当液囊22膨胀时挠性管40自身绕成盘状(如图2所示)。其结果是当液囊22充分膨胀时挠性管40所占空间最小。此外,当液囊22膨胀时挠性管40的盘绕减少或消除了其在外壳12内移动时“压紧”该管的可能性。
在优选实施例中,移动式泵10至少有一个排气孔42,其功能将在本说明书中描述。排气孔42最好位于端盖14、端盖16的其中之一上。在此实施例中,第二个端盖16上有孔42,其用疏水性材料44盖住。空气可通过疏水性材料44,液体不能通过疏水性材料44。
在本实施例中,管路50与移动式泵10连接,管路50的形状是为了直接或间接地将液体从液囊输送给患者。图3所示典型结构(包括位于管路50内的流量调节器52)见Winchell美国专利第4904239号等等,该专利通常一起转让,该专利结合在本说明书中以供参考。患者输液管路50可与移动式泵10的端盖14连接。管路50最好与移动式泵10连接(例如,作为移动式泵10的一部分)。
对于此实施例来说,第二个端盖孔20可称为注液口20,第一个端盖孔18可称为输出口。移动式泵10至少有一个阀54,其结构允许液体L从注液口20流入液囊22并注满液囊22。在此实施例结构中,构成指示件32一部分(或安装在指示件32上)的“鸭嘴形”阀54伸进液囊22中。鸭嘴形阀54允许液体L从注液口20流入液囊22并防止液囊22中的液体通过注液口20回流。
移动式泵10还有输出口56,其从第一个端盖14的孔18向内伸进液囊22中。在此实施例结构中,液囊22可封装在开口34和口56上以隔离液体流动通道,防止接在外壳12内的液囊22周围产生泄漏。输出口56的结构可以过滤从液囊22流出的液体。或者,输出口56的结构最好使液体能流动畅通,液体可用输出口外的调节器52调节,例如在上面提到的Winchell等专利中所说明的那样。
注液口20可以包括安装部分和连接部分,例如Luer锁定接口,使得可用标准的、现有的医疗器械灌注移动式泵10。注液口20最好可与用来保护注液口20接口的保护盖58相配合,以保证泵10结构的完整性,减少泵10和液体L被污染的可能性。在典型实施例中,注液口20有凹型Luer锁定接口,保护盖58有与注液口20相配合的凸型Luer锁定接口。
本移动式泵10的优点是不需要为了注入液囊时控制指示件的位置而向内弯曲或压紧外壳。相反地,因为注液口20位于刚性端盖16上,端盖16通过挠性管40与弹性材料的液囊22连接,可控制端盖16或端盖16周围的外壳12,可使液体供应源(例如灌注器)与注液口20连接以便注满液囊22。这样,当将灌注器或其他液体供应源连接到移动式泵10上时,任何扭转运动(例如使用Luer接口所必须的扭转运动)只传送给刚性注液口20,而不传送给液囊22。
现在参见图2,当注满液囊22时,其膨胀。作用在指示件32上的来自膨胀液囊22的力使指示件32朝注液口20移动。当指示件32朝注液口20移动时,挠性管40盘绕以容纳膨胀的液囊22。当注入液囊22的液体达到期望量时,可断开供应源,再将保护盖58盖在注液口20上。此时,再盖上保护盖58减少了损害注液口20或污染移动式泵10中液体L的可能性。
熟悉本领域的技术人员认识到液囊22膨胀时必须从移动式泵10中排出外壳12中的空气以使外壳12内腔15的气压保持在一个大气压左右。虽然端盖16上的排气孔42的尺寸足够空气出入使得外壳12内的气压保持在一个大气压左右,但排气孔42的尺寸还是足够小到液囊22破裂后液体L的必然损失均在外壳12内。如上所述,在优选实施例中,排气孔42用疏水性材料44盖住。熟悉本领域的技术人员认识到这样的疏水性材料允许空气或其它气体实质上通过疏水性材料44使外壳12内的空间60基本上保持一个大气压,而疏水性材料阻止液体(例如万一液囊22破裂流出的水)的通过。
可以预料,本移动式泵10的各个元件可用现有的、通常所用的、可医用的材料制成。熟悉本领域的技术人员认识到这些材料可用各种现有的、可医用的技术互相粘结。例如,端盖14、端盖16用溶性粘结剂粘结在外壳12上。液囊22可装在指示件32的开口34上并且可通过机械附件装在输出口56上,例如图示圈64或类似物。
本移动式泵10的优点是可解决现有移动式泵遇到的问题。如上所述,在灌注移动式泵10之前注液口20和液囊22之间的挠性管40中有少量空气。本移动式泵在通过阀54注入液体之前,迫使这“缕”空气通过鸭嘴形阀54,而不是象现有移动式泵那样立即注入液体,实质上使注入液囊22的液体中夹杂着少量空气。对于熟悉本领域的技术人员,所夹杂空气的减少是明显的,结果是液体中形成的微小气泡大大减少或消失。当对此理论不加限制条件时,相信微小气泡的减少或消失会减少调节器毛细管62中微小气泡积聚的可能性。这样又会减少灌注移动式泵10时发生问题或流量调节器52发生阻塞的可能性。
由上述说明可以理解,在不脱离本发明新颖构思的精神和范围的情况下可进行许多改进和变型。应理解本发明并不局限于图示特定的实施例。所公开的内容将由所附权利要求覆盖落入权利要求范围的各种改进。
Claims (7)
1.一种具有一外壳和包含在所述外壳内的用于在压力下分配液体的可膨胀液囊的移动式泵,其中所述液囊的内部可通过所述液囊的一移动自由端的注射而被注液,所述移动式泵包括:
所述外壳;其具有位于所述外壳之上并密封该外壳的第一和第二个固定端盖,第一个端盖上具有形成在其中用于分配所述液体的孔;所述第二端盖具有一进口,所述可膨胀液囊限定了一内贮存的容积,所述液囊由所述外壳所装载并且在未膨胀状态和已膨胀状态之间是可膨胀的,所述液囊具有一限定与所述第一端盖流动连通的孔,并且其特征在于:
所述液囊还包括限定一注液开口的所述自由端,和在所述注液开口和所述进口之间延伸的一绕性管,从而通过所述液囊自由端开口与所述液囊的内部建立了流体连通。
2.按权利要求1的移动式泵,具有位于挠性管和液囊之间的连接件,当液囊在膨胀状态和未膨胀状态之间变化时该连接件可在外壳内纵向移动。
3.按权利要求2的移动式泵,其中该外亮用透明材料制成。
4.按权利要求3的移动式泵,其中该连接件是一个指示件并且其上有标记,该外壳上也有标记,外壳上的标记和指示件上的标记共同显示移动式泵中液体的可测定容积。
5.按权利要求1的移动式泵,其中上述端盖的其中之一有排气孔。
6.按权利要求5的移动式泵,其中该排气孔包括疏水性材料制成的覆盖物。
7.按权利要求1的移动式泵,包括在第一个端盖孔与移动式泵连接的管路,该管路包括流量调节器。
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US08/997,787 | 1997-12-24 | ||
US08/997,787 US5897530A (en) | 1997-12-24 | 1997-12-24 | Enclosed ambulatory pump |
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CN1152720C true CN1152720C (zh) | 2004-06-09 |
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CN (1) | CN1152720C (zh) |
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DK (1) | DK0944405T3 (zh) |
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-
1997
- 1997-12-24 US US08/997,787 patent/US5897530A/en not_active Expired - Fee Related
-
1998
- 1998-11-13 CN CNB988011239A patent/CN1152720C/zh not_active Expired - Fee Related
- 1998-11-13 DK DK98957949T patent/DK0944405T3/da active
- 1998-11-13 WO PCT/US1998/024316 patent/WO1999033503A1/en active IP Right Grant
- 1998-11-13 DE DE69803831T patent/DE69803831T2/de not_active Expired - Lifetime
- 1998-11-13 AT AT98957949T patent/ATE213171T1/de active
- 1998-11-13 EP EP98957949A patent/EP0944405B1/en not_active Expired - Lifetime
- 1998-11-13 KR KR1019997001288A patent/KR100540965B1/ko not_active IP Right Cessation
- 1998-11-13 ES ES98957949T patent/ES2173645T3/es not_active Expired - Lifetime
- 1998-11-13 PT PT98957949T patent/PT944405E/pt unknown
- 1998-11-13 JP JP53496599A patent/JP3260388B2/ja not_active Expired - Fee Related
- 1998-11-17 TW TW087118991A patent/TW374733B/zh not_active IP Right Cessation
Also Published As
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---|---|
US5897530A (en) | 1999-04-27 |
PT944405E (pt) | 2002-07-31 |
TW374733B (en) | 1999-11-21 |
EP0944405B1 (en) | 2002-02-13 |
JP3260388B2 (ja) | 2002-02-25 |
ES2173645T3 (es) | 2002-10-16 |
DE69803831D1 (de) | 2002-03-21 |
ATE213171T1 (de) | 2002-02-15 |
KR20000068176A (ko) | 2000-11-25 |
JP2000510383A (ja) | 2000-08-15 |
EP0944405A1 (en) | 1999-09-29 |
CN1236325A (zh) | 1999-11-24 |
DK0944405T3 (da) | 2002-04-02 |
DE69803831T2 (de) | 2002-10-31 |
KR100540965B1 (ko) | 2006-01-10 |
WO1999033503A1 (en) | 1999-07-08 |
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