CN1223384C - 带有可连接的插座的多腔式导液管 - Google Patents
带有可连接的插座的多腔式导液管 Download PDFInfo
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- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
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- A61M25/00—Catheters; Hollow probes
- A61M25/0097—Catheters; Hollow probes characterised by the hub
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- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
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- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
- A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
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- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0034—Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
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- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
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- A61M2025/0098—Catheters; Hollow probes having a strain relief at the proximal end, e.g. sleeve
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- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/0028—Multi-lumen catheters with stationary elements characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves
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Abstract
本发明是一种具有可选择性地连接的插座的多腔式导液管组件,包括具有近端部分和远端部分的多腔式导液管导管和具有近端部分和远端部分的插座组件,其中在所述导液管导管的近端部分***患者的皮下之后,所述导液管导管的远端部分可选择性地连接于所述插座组件的近端部分。
Description
技术领域
本发明涉及医疗设备,尤其涉及一种带有可选择性连接的插座组件的多腔式导液管,该插座组件可以在形成皮下通道之前使所述导液管的顶端精确地定位。
背景技术
导液管一般是中空的柔性管,用于***到体腔、导管或血管中,使流体通过或使通道扩张。导液管经常用于临时或长期透析治疗。透析治疗用于从患者的体内抽出血液,净化后返回患者体内。因此,在透析治疗中,导液管用于使患者的血液进、出患者的身体。为了在透析治疗中获得最佳性能,导液管的顶端,流入端和流出端,都应放置在接近心脏的位置。医护人员通常使用双腔式导液管或者两根单腔式导液管。然而,两种类型的导液管都会带来某些问题。
虽然双腔式导液管(例如,美国专利US4895561)可以将导液管一次静脉***到所需的静脉中,但双腔式导液管一般不具有导液管顶端定位的精度。由于患者之间存在差异,最佳的顶端位置随患者不同而变化。非最佳的顶端位置可能会显著降低流量值,导致透析治疗效果变差。对于现有的双腔式导液管,医师必须在导液管***工序开始前估算适当的导液管长度。然后从所述插座组件的优选端部位置,即远离患者颈部的位置,形成皮下通道,以便更方便地接近透析治疗设备。然后,双腔式导液管向前穿入患者的静脉中。最初的估算和随后的向前穿入会导致小于最佳的顶端位置。
使用两根独立的导液管(例如,美国专利US5776111和US5624413)解决了顶端位置的问题。每根导液管的插座组件都可以从导液管的导管和顶端部分去除,从而可以使导液管的顶端直接放入静脉中,并前进到所需的位置。然后,所述导液管的近端可以反向穿过,调整到所需的长度。此后,连接插座组件。然而,在这种插管方法中也存在缺点。这种方法的一个问题是,这种方法需要两次独立的静脉***,也就是说,两个通道且每一用于所述工序的附属设备有两个。因此,增加了放置两条导液管所需的手术时间,存在两个受伤的进入部位,这会使术后感染的危险加倍,并且,两条导液管加在一起在直径上明显大于一条双腔式导液管。
发明概述
本发明是一种带有可选择性连接的插座组件的多腔式导液管,该插座组件可以在形成皮下通道之前,使所述导液管的顶端精确地位于患者的静脉中。导液管导管的远端并不是永久地连接于插座组件上。因此,在所述顶端已经放好后,导液管可以反向穿过。
所述插座组件包括至少2根并列且与所述导液管导管远端的至少两个内腔对应的套管。一旦所述插座组件连接到导液管导管上而在两者之间形成流体连通,可取的是,将连接罩和可延展的压缩套筒固定到位。可取的是,所述连接罩与所述插座组件上的螺纹接头形成螺纹配合。所述连接罩和所述压缩套筒一起产生防止所述导液管导管从所述插座组件上无意中分离的力。
在阅读了下面对优选实施例和附图的描述之后,对于本领域的技术人员来说,上述的本发明的这些和其他方面将会非常明显。这些描述和附图是为了描述本发明的优选实施例,并不是为了限制本发明。
附图简要说明
图1是本发明的多腔式导液管组件的分解透视图。
图2是本发明的多腔式导液管的插座组件的放大分解透视图,包括插座本体的第一截面图。
图3是本发明的插座组件和导液管导管的远端部分的放大分解透视图,包括插座本体的第一截面图。
图4是本发明的多腔式导液管的导液管导管的第一截面图。
图5是本发明的导液管导管的放大透视图。
图6是组装后的本发明的多腔式导液管组件的透视图。
优选实施例详细描述
如图所示,本发明是一种多腔式导液管组件10,具有可选择性地连接的插座组件20。如图1所示,多腔式导液管导管12具有近端部分12a和远端部分12b。导液管导管12的远端部分12b可选择性地连接于插座组件20的近端部分20a上。这样,插座组件20可以在包括顶端14和16的导液管导管的近端部分12a***到患者体内后,连接于导液管导管12上。
如图2所示,可取的是,插座组件20具有第一套管22和第二套管24。每个套管分别具有近端部分22a和24a,以及远端部分22b和24b。而且,每根套管22和24分别具有相应的延伸管26和28。每根延伸管26和28分别具有近端部分26a和28a,以及远端部分26b和28b。通过各自的近端和远端部分形成的适当接头,即所述套管的远端部分22b和24b分别与延伸管的远端部分26a和28a的接头,每根延伸管26和28分别与第一套管22和第二套管24流体连通。虽然在附图中示出了带有两根套管的插座组件,但任何适当构造和数量的套管都应认为在本发明的范围内。
如图2所示,可取的是,插座本体21用于保持第一延伸管26和第二延伸管28之间约15度的夹角A。该角最好根据将导液管组件10连接于流体输送装置,例如透析设备的必要性确定。
回到图1,插座组件20还包括第一连接器30和第二连接器32。连接器30、32可以是luer连接件,如本领域所公知。第一连接器30牢固地连接于第一延伸管的远端部分26b,第二连接器32牢固地连接于第二延伸管的远端部分28b。可取的是,每个连接器30、32都可以连接到流体输送装置上(未示出),例如透析设备,如本领域所公知。因此,相应的套管22和24分别与延伸管26和28流体连通。因此,套管22和24分别用于流体输送装置的流入和流出操作。
每根延伸管26和28分别设有夹子42和44,用于在所述导液管组件10未连接于流体输送装置时夹住延伸管26和28。
插座本体21具有两个连接缝合翅片38和40,可用于在导液管组件***患者体内后将导液管组件10缝合在患者上,以保持导液管组件10的位置。
如图3所示,可取的是,插座组件20这样制成,即套管的每一近端22a和24a具有通常D形的截面。可取的是,套管的每一远端部分22b和24b具有通常O形的截面。因此,可取的是,每一延伸管26和28的近端部分26a和28a具有通常O形的截面,且用于接纳相应的第一和第二套管22和24的远端部分22b和24b。套管22、24,延伸管26、28和导液管导管12的内腔13、17的形状和截面结构可以变化,因此,本发明的范围不应限于上述的优选结构。
可取的是,插座本体21在每一延伸管的近端部分和每一套管的远端部分周围形成。如图2所示,插座本体21用于防止套管22、24和延伸管26、28之间的几个接头脱开。而且,插座本体21形成用于导液管12连接的机构。具体而言,插座本体21具有近端部分21a和远端部分21b。如前所述,插座本体21可选择性地连接于导液管导管12的远端部分12b,从而利用导液管导管12的内腔13和17,在各套管22和24之间形成流体连通(经套管22a和24a),下面将详细描述。
如图5所示,导液管导管12具有第一内腔13和第二内腔17。第一和第二内腔13、17分别具有通常D形的截面。纵向延伸的隔膜15限定了每一内腔13、17,直到导液管导管的远端部分12b,如图4所示。所以,每一内腔13、17连接于相应的套管22、24,以形成流体连通。
可取的是,导液管导管12的远端部分12b的每一内腔13、17,和套管22和24的近端22a和24a由比如颜色的标志对应地标记,以确保连接时正确地对应匹配。为了进一步确保匹配的对应性,可取的是,顶端14、16,延伸管26、28和连接器30、32采取相同的标记模式。因此,例如,顶端14、内腔13、套管22、延伸管26和连接器30用第一标志(例如蓝色)来标记,而顶端16、内腔17、套管24、延伸管28和连接器32用第二标志(例如红色)来标记。这样,第一标志与内腔之一相关,而第二标志与另一内腔对应,从而第一标志和第二标志确定了内腔和对应的套管、延伸管和连接器之间的对应性。虽然所述标志是可视标志,比如颜色,但具有任何可视的、可触的和其他方式的标志的可选择性连接的多腔式导液管都应认为在本发明的范围内。
如上所述,本发明描述了具有两个套管和双内腔的导液管的优选实施例。然而,本发明不应限于该优选实施例,其他适当的结构也应认为在本发明的范围内。例如,导液管导管和对应的套管可以是不同直径变化的一系列同心管。或者,所述组件10可以形成提供与上述类似的结构,具有三个(或更多)套管和三个(或更多)内腔的导液管导管。然而,优选实施例包括具有双内腔的导液导管的两个套管。
可取的是,如图3所示,套管22、24的近端部分22a、24a和导液管导管12的远端部分12b处的内腔13和17之间的接头是重叠配合接头。然而,可以采用任何其他适当的紧固方式,比如棘爪。
参照图1,示出了在插座本体21和导液管导管12之间的优选接头示例,该示例包括具有近端部分34a和远端部分34b的连接罩34。连接罩34应当沿轴向装配在导液管导管12的远端部分12b周围。连接罩34的远端34b适当地形成螺纹,而使连接罩34可选择性地连接于插座本体21的螺纹部分21a上,使导液管导管12牢固地连接于插座组件20。例如,如图1所示,连接罩34可包括内螺纹,以选择性地接纳插座本体21上形成的外螺纹21a。
可取的是,本发明还包括压缩套筒36,该套筒沿轴向装配在导液管导管12的远端部分12b周围,且还沿轴向装配在第一和第二套管22和24的组合在一起的近端部分22a和24a周围。可取的是,压缩套筒36由可延展的材料制成,以在套管22和24与多腔导液管12之间的接头周围提供进一步的压缩。在将导液管12***患者体内之后,连接罩34和压缩套筒36一起产生阻止导液管导管12与插座本体21无意中分离的作用力。
图6示出了本发明的导液管组件10,其中插座组件20连接于导液管导管12。
用于将本发明的导液管组件10***患者体内的优选方法需要下述部件:优选具有锥形的硅酮顶端14、16的多腔式导液管导管12,如本领域所公知的导引器针头,多个可撕去护套扩张器(tearawaysheath dilator)导引器,J-弯曲导线,套针、具有夹子的锁定适配器,注射帽,手术刀,缝合线和粘结绷带。此外,医师应当可以使用剪刀、镊子、针盘、注射器和纱布。
用于将本发明的导液管***患者颈静脉中的优选方法,开始于使患者处于患者头部转向与***导液管的颈静脉相反一侧的位置。用于正确***的解剖标志由胸骨头部的外侧边缘,胸锁乳突肌的锁骨头部内侧边缘,和锁骨的上边缘形成的三角形来确定。
患者颈部和患者锁骨下的胸部,优选至少约20厘米,可以进行适当的切口准备。然后,患者应当覆盖,实施局部麻醉。
可取的是,考虑到渗入皮下组织2~3厘米,需要形成皮轮(skinwheel)。接着,优选使用连接于注射器的18号针头,医师应当通过抽吸作用识别颈静脉,然后以某一角度前进,同时继续使用注射器吸取。一旦颈静脉已经定位,所述优选方法包括卸下注射器,同时针头留在原位。针头的开口应当封闭,然后,J-弯曲导线应当穿过所述针头,进入颈静脉。所述导线应当没有阻挡地通过,到达正确的位置。然后所述针头应当去除,使所述导线留在适当位置。所述导线应当位于上腔静脉和右心房的接合部位。适当的导线定位可使用透视检查来确认。
接着,使用解剖刀,医师在皮肤上形成切口,切口的宽度应足以使导液管导管12通过。可撕去护套扩张器可以在导线上引导,进入静脉中足够远,以便扩张血管。在扩张了静脉壁后,可以除去导线,同时封闭所述扩张器的开口。通过顺时针旋转套针,可以将套针拧到导液管导管12上,而不是旋转导液管导管12。旋转导液管导管12会引起扭结。可以去除扩张器,使可撕去护套留在适当的位置,引导导液管导管12,然后应当再次仔细地封闭护套的开口。当导液管导管12已经送入到所述护套中时,可以将可撕去护套撕掉。应当仔细,不使导液管导管12从血管退出。
通过上述患者定位,以及要求患者深吸气后屏住呼吸,可以避免气泡栓塞。此时,可以透视检查来确认导液管导管12的位置。静脉导液管的顶端14应到达右心房的开口处,动脉导液管的顶端16应高出约4cm。如上所述,正确定位是非常重要的。所述的定位被认为可以防止血液透析过程中血液回流。
接着,应当沿尾部和内部的方向通过通道器形成约8至10cm的通道,该通道可以形成医师喜欢的形状。导液管导管12应当轻柔地穿过通道,直到最初穿孔处的环通过。当正确***时,导液管导管12应当停在锁骨上方。应当细心,以避免力量过大,这可能导致导液管导管12与通道分离。可取的是,所述方法包括检查这一区域,以确保导液管导管12没有扭结,且是平滑的转弯。
随后,在夹住导液管导管12的远端部分12b时,插座组件20连接于导液管导管12。连接器34在导液管导管12上方稍有变化。接着,压缩套筒36在导液管导管12上方稍有变化。套管22、24的近端部分22a、24a分别***内腔13和17中,形成摩擦配合。可取的是,套管22、24,或对应的延伸管26、28或对应的连接器30、32作有标记,而使套管22、24***正确的内腔13、17中。
在使连接罩34和压缩套筒36在导液管导管12上方稍稍变化之后,压缩套筒36滑入大致邻近插座本体21的螺纹部分21a的位置。最后,连接罩34通过转动连接罩34而连接于插座本体21,使连接罩34的内螺纹接纳插座本体21的外螺纹21a,从而形成插座组件20到导液管导管12的牢固连接。夹子42、44可用于延伸管26、28。
延伸管26、28应当填充3至4cc的5000单位的生理盐水,夹紧,并利用注射帽连接。应当再次进行X射线检查,以再次确认位置。所述小切口由缝合线封闭。现在,患者可以进行透析。
可取的是,导液管导管12由不透射线的硅酮制成,以有利于透视检查时的可视化。
虽然已经详细示出和描述了本发明的具体实施例,但明显可以理解,本发明不限于此。上面对实施例的详细描述仅是作为示例提供的,不应构成对本发明的任何限制。对于本领域的技术人员来说,显然可以作出改进,且所有改进都不脱离本发明的思想,都应认为在本发明所要求保护的范围之内。
Claims (11)
1.一种具有可选择性连接的插座的多腔式导液管组件,包含:
具有近端部分和远端部分的多腔式导液管导管;
具有近端部分和远端部分的插座组件;
其特征在于在所述导液管导管的近端部分***患者的皮下之后,所述导液管导管的远端部分可选择性地连接于所述插座组件的近端部分。
2.如权利要求1所述的多腔式导液管组件,其特征在于所述导液管导管具有第一内腔和第二内腔,且所述插座组件还包含:
第一套管和第二套管,其中每一套管具有近端部分和远端部分,所述第一套管的近端部分可连接于所述导液管导管的第一内腔,所述第二套管的近端部分可连接于所述导液管导管的第二内腔,而在其两者之间形成流体连通;
第一延伸管和第二延伸管,其中每一延伸管具有近端部分和远端部分,且第一延伸管的近端部分可连接于第一套管的远端部分,第二延伸管的近端部分可连接于第二套管的远端部分,而在两者之间形成流体连通;
第一连接器和第二连接器,第一连接器牢固地连接于第一延伸管的远端部分,第二连接器牢固地连接于第二延伸管的远端部分,
其中每一连接器可连接于流体输送装置,以在插座组件和导液管导管之间提供流体流。
3.如权利要求2所述的多腔式导液管组件,其特征在于第一和第二套管的近端部分分别具有D形的截面,第一和第二套管的远端部分分别具有O形的截面。
4.如权利要求3所述的多腔式导液管组件,其特征在于每一延伸管的近端部分具有O形的截面,且用于接纳相应套管的远端部分。
5.如权利要求2所述的多腔式导液管组件,其特征在于还包含在每一延伸管的近端部分和每一套管的远端部分之间的接头周围形成的插座本体。
6.如权利要求5所述的多腔式导液管组件,其特征在于还包含:
具有近端部分和远端部分的连接罩,其中该罩沿轴向装配在所述导液管导管的远端部分周围;
压缩套筒,该压缩套筒沿轴向装配在所述导液管导管的远端部分和第一和第二套管的近端部分周围;
其中所述罩的远端可选择性地连接于所述插座组件。
7.如权利要求6所述的多腔式导液管组件,其特征在于所述插座本体具有近端部分和远端部分,所述插座本体的近端部分可选择性地连接于连接罩的远端部分,而使导液管牢固地连接于插座组件。
8.如权利要求2所述的多腔式导液管组件,其特征在于第一套管和第二套管之间的夹角约15度。
9.如权利要求1所述的多腔式导液管组件,其特征在于所述导液管的近端部分还包含
第一和第二内腔,第一和第二内腔分别具有D形的截面,其中第一和第二内腔分别朝导液管导管的远端部分过渡成一个具有纵向延伸的隔膜的内腔。
10.如权利要求2所述的多腔式导液管组件,其特征在于
第一标志与第一内腔、第一套管和第一连接器相关;
第二标志与第二内腔、第二套管和第二连接器相关;
所以第一标志和第二标志确定了内腔、套管和连接器之间匹配的对应性。
11.一种具有可选择性连接的插座的多腔式导液管组件,包含:
a)具有近端部分和远端部分以及第一内腔和第二内腔的多腔式导液管导管;
b)插座组件,所述插座组件还包含:
i)第一套管和第二套管,其中每一套管具有D形截面的近端部分和O形截面的远端部分,所述第一套管的近端部分可连接于所述导液管导管的第一内腔,所述第二套管的近端部分可连接于所述导液管导管的第二内腔,而在其两者之间形成流体连通;
ii)第一延伸管和第二延伸管,其中每一延伸管具有近端部分和远端部分,且第一延伸管的近端部分具有O形截面并可连接于第一套管的远端部分,第二延伸管的近端部分具有O形截面并可连接于第二套管的远端部分,而在两者之间形成流体连通;
iii)第一连接器和第二连接器,第一连接器牢固地连接于第一延伸管的远端部分,第二连接器牢固地连接于第二延伸管的远端部分,
iv)具有近端部分和远端部分的插座本体,所述插座本体在每个第一和第二延伸管的近端部分与每个第一和第二套管的远端部分之间的接头周围分别形成;
v)第一标志与第一内腔、第一套管和第一连接器相关;
第二标志与第二内腔、第二套管和第二连接器相关;
所以第一标志和第二标志确定了内腔、套管和连接器之间匹配的对应性;
c)具有近端部分和远端部分的连接罩,其中该罩沿轴向装配在导液管导管的远端部分周围;
d)压缩套筒,该压缩套筒沿轴向装配在导液管导管的远端部分和第一和第二套管的近端部分周围;
其特征在于所述插座本体的近端部分可选择性地连接于连接器罩的远端部分,从而在所述导液管导管的近端部分***患者的皮下之后,所述导液管导管可选择性地连接于所述插座组件的近端部分。
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US09/769,052 | 2001-01-24 |
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-
2001
- 2001-01-24 US US09/769,052 patent/US20020099326A1/en not_active Abandoned
-
2002
- 2002-01-24 AT AT02705931T patent/ATE395945T1/de not_active IP Right Cessation
- 2002-01-24 AU AU2002240049A patent/AU2002240049B2/en not_active Expired
- 2002-01-24 WO PCT/US2002/001996 patent/WO2002058776A2/en active Application Filing
- 2002-01-24 MX MXPA03006558A patent/MXPA03006558A/es active IP Right Grant
- 2002-01-24 CZ CZ20032071A patent/CZ20032071A3/cs unknown
- 2002-01-24 CN CNB028053559A patent/CN1223384C/zh not_active Expired - Lifetime
- 2002-01-24 JP JP2002559106A patent/JP2004526481A/ja active Pending
- 2002-01-24 CA CA002435697A patent/CA2435697C/en not_active Expired - Lifetime
- 2002-01-24 PT PT02705931T patent/PT1353719E/pt unknown
- 2002-01-24 EP EP02705931A patent/EP1353719B1/en not_active Expired - Lifetime
- 2002-01-24 DE DE60226701T patent/DE60226701D1/de not_active Expired - Lifetime
- 2002-01-24 ES ES02705931T patent/ES2307727T3/es not_active Expired - Lifetime
- 2002-02-28 US US10/086,033 patent/US6638242B2/en not_active Expired - Lifetime
-
2003
- 2003-07-01 US US10/612,532 patent/US7381204B2/en not_active Expired - Lifetime
-
2007
- 2007-09-26 US US11/861,722 patent/US7833214B2/en not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
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PT1353719E (pt) | 2008-09-01 |
WO2002058776A2 (en) | 2002-08-01 |
CZ20032071A3 (cs) | 2004-06-16 |
JP2004526481A (ja) | 2004-09-02 |
US7381204B2 (en) | 2008-06-03 |
EP1353719A2 (en) | 2003-10-22 |
ES2307727T3 (es) | 2008-12-01 |
US20080033350A1 (en) | 2008-02-07 |
DE60226701D1 (de) | 2008-07-03 |
AU2002240049B2 (en) | 2007-01-04 |
CN1498125A (zh) | 2004-05-19 |
US20020099327A1 (en) | 2002-07-25 |
US20040065333A1 (en) | 2004-04-08 |
WO2002058776A3 (en) | 2003-02-27 |
US7833214B2 (en) | 2010-11-16 |
MXPA03006558A (es) | 2004-04-02 |
US6638242B2 (en) | 2003-10-28 |
EP1353719B1 (en) | 2008-05-21 |
CA2435697A1 (en) | 2002-08-01 |
ATE395945T1 (de) | 2008-06-15 |
US20020099326A1 (en) | 2002-07-25 |
CA2435697C (en) | 2009-12-15 |
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