CN104936571B - 低轮廓进入端口 - Google Patents
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Abstract
公开了一种用于在患者的体内皮下植入的低轮廓进入端口。进入端口包括接收杯,所述接收杯提供相对大的皮下目标以使得承载导管的针能够无困难地进入所述端口。此外,进入端口包括阀/密封件组件,以允许通过所述端口的加压的流体注入,同时阻止回流。因此,在一个实施方案中,低轮廓进入端口包括本体,所述本体包括管道和接收杯,所述管道具有在所述管道的近侧端的入口端口。所述接收杯成凹形以将承载导管的针经由所述入口端口引导到所述管道中。所述接收杯在所述患者体内被皮下植入时基本上朝向皮肤表面取向,以易于针碰击所述接收杯。阀/密封件组件被设置在所述管道中,使得所述导管能够通过所述管道,同时阻止流体回流。
Description
相关申请的交叉引用:本申请要求2013年1月23日递交的、并且题为“低轮廓进入端口(Low Profile Access Port)”的美国临时专利申请No.61/755,913的权益,该申请通过引用被整体并入本文。
发明内容
简要地概述,本发明的实施方案涉及一种用于在患者的体内皮下植入的低轮廓进入端口。该进入端口包括接收杯,所述接收杯提供相对大的皮下目标以使得承载导管的针能够无困难地进入该端口。此外,进入端口包括阀/密封件组件,以允许通过该端口的加压的流体注入,同时阻止回流。
因此,在一个实施方案中,低轮廓进入端口包括本体,所述本体包括管道和接收杯,所述管道具有在所述管道的近侧端的入口端口。所述接收杯成凹形以将承载导管的针经由所述入口端口引导到所述管道中。所述接收杯在所述患者体内被皮下植入时基本上朝向皮肤表面取向,以易于针碰击所述接收杯。阀/密封件组件被设置在所述管道中,使得所述导管能够通过所述管道,同时阻止流体回流。
本发明实施方案的这些和其他特征将从下面的说明和所附的权利要求书中变得更加完整清晰,或者可以通过对由下文所阐明的本发明实施方案的实践来获悉。
附图的简要说明
将通过参考本发明的具体的实施方案提供对本发明的更加具体的描述,所述的具体实施方案在所附的附图中被图示说明。可以理解,这些附图仅描绘本发明的典型实施方案,因而不能被认为是对本发明范围的限制。将通过使用说明书附图来以附加的特征和细节对本发明的示例性实施方案进行描述和解释,其中:
图1A-图1E示出根据一个实施方案的进入端口的各种视图;
图2为图1A-图1E的进入端口的截面图;
图3A-图3C为根据一个实施方案的低轮廓进入端口的各种视图;
图4为根据一个实施方案的低轮廓进入端口的顶视图;
图5为根据一个实施方案的低轮廓进入端口的透视图;
图6为根据一个实施方案的低轮廓进入端口的透视图;
图7A和图7B为根据一个实施方案的进入端口的各种视图;以及
图8A和图8B为根据一个实施方案的进入端口的各种视图。
选定实施方案的详细描述
现在将参考附图,其中相似的结构将被提供以相似的参考编号。可以理解,附图为本发明的示例性实施方案的图解的和示意的表征,并且所述附图为非限制性的,也无须按比例绘制。
为清楚起见,将理解的是,词语“近侧的(proximal)”是指相对更靠近使用本文要描述的装置的临床医生的方向,而词语“远侧的(distal)”是指相对更远离临床医生的方向。例如,被放置在患者体内的导管的端被认为是所述导管的远侧端,而所述导管仍保留在体外的端为所述导管的近侧端。另外,如本文(包括权利要求书)所使用的词语“包括(including)”、“具有(has)”以及“具有(having)”,应当具有同词语“包括(comprising)”相同的意思。
本发明的实施方案总地涉及一种用于在患者的体内皮下植入的进入端口。植入的进入端口是由承载导管的针(例如外周静脉(“PIV”)导管)经皮可进入的,以便将PIV导管放置为与进入端口流体连通。在一个实施方案中,进入端口的流体出口被可操作地连接到设置在患者的脉管系统内的留置导管,以使得到患者的脉管系统的输注和/或流体从患者的脉管系统的移出能够经由PIV导管来进行。
根据一个实施方案,进入端口限定低轮廓以便易于放置在患者的皮下组织内。进一步地,进入端口被配置来提供相对大的皮下目标以使得PIV导管或其他适合的承载导管的针能够无困难地进入该端口。此外,进入端口包括阀/密封件组件,以允许以相对高的流率(例如在约300psi的压力下约5ml/s)通过进入端口的流体的注入(在本文也被称为“动力注入”)。对于本文所描述的进入端口的可能的应用包括针对患者的药物和其他流体的给药、提取、流体抽吸等。
首先参照图1A-图1E,图1A-图1E示出根据一个实施方案的一般被标注为10的进入端口的各种细节。如所示出的,端口10包括本体12,所述本体12在本实施方案中由第一部分12A和第二部分12B限定(图1E)。在本实施方案中,端口本体12包括金属(例如钛),并且如此一来,第二部分12B被压入配合为与第一部分12A结合来限定本体,虽然理解的是,端口本体可以包括各种其他材料,包括金属、热塑性塑料、陶瓷等。
在本实施方案中,如下面所进一步描述的,端口本体12限定基本上成凹形的接收杯14,用于接收和引导承载导管的针(图2)以可操作地与端口10连接。特别地,该基本上成凹形的接收杯14被配置来朝向入口端口16引导碰击接收杯14的承载导管的针(图2),所述入口端口16用作由端口本体12限定的管道18的开口。如图2所看到的,接收杯14的敞开的并且浅的本质与其基本上向上的取向(即,朝向患者的皮肤表面)一起,(这以至于当它在患者的皮肤下被皮下植入时基本上平行于皮肤表面(即,当皮肤处于静态或未因手指压力或操控而变形时,接收杯基本上平行于皮肤表面)),使得接收杯能够在针被引入皮肤时为针呈现大的、可容易进入的目标。图2进一步示出端口10限定相对低的轮廓高度,这使得在植入之后相对较短的针的长度能够用于进入该端口。
触按部分26与端口本体12一起被包括,以在植入患者的皮肤下之后辅助临床医生经由手指触按来定位和/或识别端口10。详细地,在本实施方案中,触按部分26包括被设置为靠近接收杯14的近侧端的隆起26A以及被设置在接收杯的远侧部分之上并且围绕接收杯的远侧部分弯曲的脊26B。图1B示出触按部分在由端口10限定的一般上部的面之上延伸,以便临床医生对该部分的触按来定位接收杯14的位置和/或取向。注意的是,除了本文所示出和描述的之外,各种其他尺寸、配置、数目等的触按部分可以被包括在端口上。
引导槽28被限定在接收杯14上并且与管道18的入口端口16纵向对准。引导槽28相对于接收杯14的表面的邻近部分被限定为凹陷区,并且沿接收杯表面从接收杯的近侧部分向远侧延伸以便提供引导路径,一旦发生针碰击引导槽,则朝向入口端口16引导承载导管的针的远侧末端。这又降低了针在插入期间滑动穿过并且离开接收杯14的机会。注意的是,这些和其他类似的特征,虽然在形状和配置上不同,也可以被包括在本文所公开的其他端口上。
如在图1E中所最佳地看到的,端口本体12进一步将管道18限定为经皮插入的导管可以通过的通路,以便将导管放置为与端口10流体连通。如所示出的,管道18经由入口端口16与接收杯14连通。管道18的第一管道部分18A在从图1E所示出的透视图中成角度的向下的方向上从入口端口16向远侧延伸到弯折30,在弯折30,管道的第二管道部分18B略微向上成一角度并且以预先确定的角度θ1改变方向。注意的是,在一个实施方案中,角度取向θ1约为37度,但在其他实施方案中可以与该角度不同,在一个实施方案中包括小于37度的角度。在一个实施方案中,角度θ1的取决于各种因素,包括要被插入到端口管道中的导管和/或针的尺寸、管道本身的尺寸等。
管道18接着延伸到并且通过由端口本体的阀壳体20限定的腔20A。管道18延伸到端口10的导杆24的远侧开口端。如会被看到的,管道18被选定尺寸以便使得导管40(图2)能够通过管道18。
如所提及的,阀壳体20限定管道通过的并且容纳阀/密封件组件22的腔20A。阀/密封件组件22包括密封元件或密封件32(其限定导管40可以通过的中心孔)、第一裂隙阀34A和第二裂隙阀34B。在一个实施方案中,如图1E所示,密封件32和阀34A、34B被夹在一起并且被固定在腔20A内的适当位置。在本实施方案中,裂隙阀34A、34B的裂隙以约90度旋转偏离彼此,虽然其他关系是可能的。
阀/密封件组件22的密封件32和阀34A、34B合作以使能导管40(图2)流体密封地通过它们的同时还阻止通过阀/密封件组件的流体的回流。确实,在一个实施方案中,当导管被设置通过密封件时,本文所公开的密封件阻止围绕导管的外部部分的流体流动,而当没有导管通过阀时,阀适合于阻止流体流动。如此一来,当导管40没有插入阀/密封件组件22时,阀/密封件组件22密封以阻止空气或流体通过。在本实施方案中,密封件32和阀34A、34B包括硅酮,虽然其他适合的顺从性材料可以被采用。
在本实施方案中,端口10包括覆盖端口本体12的包覆模制的部分36。包覆模制的部分36包括硅酮或其他适合的顺从性材料并且如所示出的围绕本体12,以便为端口10提供相对软的表面并且降低端口植入之后患者的不适。包覆模制的部分36包括两个预先确定的缝合位置38(在图1C所最好看到的),用于将端口10缝合到患者组织,虽然如果期望的话,缝合可以通过包覆模制的部分的其他部分。包覆模制的部分36进一步限定相对平的底部表面36A,以便在植入之后在组织袋内的它的位置上为端口10提供稳定的表面。相比之下,图3C所示的端口包括具有稍微成圆形的轮廓的底部表面。
图2描绘根据一个实施方案的关于设置在针42上的导管40的插入的细节。在经由触按部分26的通过皮肤的触按定位端口10之后,临床医生使用承载导管的针42来穿入皮肤表面44并且插入针直到它的远侧末端42A如所示出的碰击接收杯14的一部分。注意的是,由于接收杯14取向为基本上平行于皮肤表面,针42可以以插入角度θ2(其是相对陡的)碰击接收杯,这便利针易于插入本体。确实,在一个实施方案中,基本上正交地插入通过患者的皮肤的针可以碰击进入端口的接收杯。
针42被操控直到远侧末端42A被接收到引导槽28中,这将使得远侧末端能够沿槽被引导到入口端口16。然后针42被插入通过入口端口16并且进入管道18的第一部分18A直到它被弯折30停止。然后针42可以向近侧退回小的距离,并且导管40推进超出针,以使导管弯曲并且推进通过弯折30进入管道18的第二部分18B。导管推进继续以使导管40的远侧端40A推进进入并且通过密封件32的孔并且通过阀/密封件组件40的裂隙阀34A、34B的两个裂隙。一旦导管40的远侧端40A已经向远侧延伸通过阀/密封件组件22,进一步的推进可以停止并且通过导管40和端口10的流体转移可以开始,包括通过导杆24的输注和/或抽吸。一旦流体转移完成,导管40可以向近侧撤回通过阀/密封件组件22和管道,然后撤回通过皮肤的表面44并且脱离患者。
图3A-图3C描绘根据另一个实施方案的进入端口110。注意的是,各种类似之处存在于本文所示出和描述的端口10和其他端口之间。如此一来,仅被选择的端口方面在下面被讨论。如所示出的,端口110包括本体112,所述本体112又包括第一本体部分112A和第二本体部分112B(在图3C所最佳地看到的)。在本实施方案中,本体112包括热塑性塑料,例如在本实施方案中的乙酰树脂。如此一来,在本实施方案中,第一和第二本体部分112A、112B被超声焊接到彼此以限定本体12。如之前,接收杯114与本体112一起被包括并且经由入口端口116可操作地连接到管道118。同样,注意的是,各种材料可以被用来限定端口本体、接收杯、管道等。
阀/密封件122被设置在由阀壳体120限定的腔120A内,在本实施方案中,所述腔120A由第一本体部分112A限定。阀/密封件组件122包括具有用于导管通过的中心孔的近侧密封件132、两个裂隙阀134A、134B(每个具有相对于彼此以90度的偏移布置的缝隙),以及具有中心孔的远侧密封件135(在本文也被称为括约肌密封件)。
远侧密封件135在它的远侧表面上包括绕密封件中心孔设置的截头圆锥形的部分135A,所述截头圆锥形的部分135A被配置来在导管延伸通过阀/密封件组件时绕导管的外表面提供像括约肌的密封件。截头圆锥形的部分135A被这样设置以使冲击截头圆锥形的部分的任何回流的流体将引起密封件以甚至更紧密的结合绕导管的外表面来紧固它本身,从而当高流体压力存在时(例如在动力注入的情况下)阻止通过导管外表面的回流。如所提及的,阀/密封件组件也可以包括其他阀/密封件组合。
在本实施方案中,接收杯114和在阀/密封件组件122近侧的管道118的部分都包括针不能穿过的内衬,所述针不能穿过的内衬在针碰击表面时阻止针的远侧端凿击表面。这又防止由针掘出的材料微粒这样不合期望的产物。对于针不能穿过的材料,各种适合的材料可以被采用,包括玻璃、陶瓷、金属等。在一个实施方案中,端口110的部件均是不含金属的,以使端口被认为是MRI安全的,当端口在患者体内被植入时,端口在由MRI获取的患者的MRI图像中不产生不合期望的伪影。
图4描绘根据另一个实施方案的端口110的附加部分。如所示出的,在本实施方案中,接收杯18包括不透射线的标记128,以指示端口110的特征。这里,不透射线的标记128包括由不透射线的材料(例如钨、三氧化铋等)形成的“C”和“T”,以便在端口植入之后经由x射线成像技术是可见的。例如,不透射线的材料可以被形成为插入件,所述插入件被插入成型地包括在端口本体中,就像在硬化之前被注入到端口本体的腔中的最初可流动的材料一样,等等。在端口本体是含金属的实施方案中,不透射线的标记可以通过刻蚀、雕刻或以其他方式在标记和围绕端口本体的材料之间产生相对厚度差异,以便产生在x射线图像中呈现的x射线可识别的对比。
在本实施方案中,CT不透射线的标记128指示观察者端口能够实现通过所述端口的流体的动力注入。如本领域的技术人员所理解的,除了该特征,其他特征可以被各种其他类型的标记指示。
进一步地,在本实施方案中,图4的端口110的俯视图指示在围绕接收杯114的区域的端口本体112限定一般的三角形,这可以在植入之后被临床医生触按并且可以不仅指示接收杯的位置还可以指示端口的特定的特征,例如其被用于动力注入的能力。当然,在其他实施方案中,接收杯可以限定除了三角形之外的形状。
图4进一步示出绕接收杯114的外周分布的是三个触按部分126,即,三个缝合插头126A被设置在由端口本体112所限定的相应的孔中。在本实施方案中,缝合插头126A包括凸起的硅酮隆起,并且在针插入患者之前当它们被临床医生触按时可以用来定位接收杯114植入后的位置。在其他实施方案中,各种其他触按部分可以与端口一起被包括。
图5描绘根据一个实施方案的低轮廓端口210的细节,包括限定凹形接收杯214的本体212以及被安置为相对于接收杯稍微远离中心的入口端口216。导杆224作为流体出口被包括。
图6描绘根据另一个实施方案的低轮廓端口210,其中本体212限定附加的表面部分,包括在接收杯214的远侧的凸起的触按部分226。根据图5和图6,由此理解的是,端口可以以各种形状和配置被配置,以提供低轮廓的方案用于提供血管进入。同样注意的是,接收杯的形状、设计和配置可以与本文所明确示出和描述的不同。
图7A和图7B描绘根据一个实施方案的低轮廓双重本体的进入端口310的各种细节,其中端口本体312中的每个限定侧向朝向的接收杯314并且包括通向管道318的入口端口316。管道318向远侧延伸到设置在阀壳体320中的阀/密封件组件322,在本实施方案中,所述阀壳体320由本体312的一部分限定。管道318延伸通过端口324。顺从性包覆模制的部分324覆盖端口310的每个本体312的部分并且可操作地将本体彼此接合。本体312可以包括任何适合的材料,包括金属、热塑性塑料等。
图8A和图8B描绘根据一个实施方案的低轮廓双重本体的进入端口410的各种细节,其中端口本体412限定双重流体路径。每个流体路径包括接收杯414,所述接收杯414由本体412限定并且从图8A和图8B所示出的透视图中面向基本上向上的取向。入口端口416与每个接收杯414一起被包括并且限定到管道418的开口。每个管道418向远侧延伸到设置在阀壳体420中的阀/密封件组件422,在本实施方案中,所述阀壳体420由本体412的一部分限定。管道418延伸通过端口424。本体412可以包括任何适合的材料,包括金属、热塑性塑料等。
本发明的实施方案可以以其他具体的形式实施,而不偏离本发明的精神。所描述的实施方案应被认为是在各方面都仅是作为图示说明性的而非限制性的。因而,本发明实施方案的范围由所附的权利要求书而非前述说明书所示出。在权利要求书的含义和等同范围内的所有变化都应被包含在本发明的范围内。
Claims (20)
1.一种用于在患者体中皮下放置的低轮廓进入端口,所述进入端口包括:
本体,所述本体包括:
管道,所述管道包括在所述管道的近侧端的入口端口;
与所述入口端口连通的接收杯,所述接收杯成凹形且包括引导槽以将承载导管的针的碰击的远侧末端经由所述入口端口引导到所述管道中,所述接收杯在所述患者体内被皮下植入时基本上朝向皮肤表面取向,所述引导槽与所述入口端口纵向对准;
触按特征,其用于在植入患者的皮肤下之后辅助临床医生经由手指触按来定位和/或识别所述低轮廓进入端口,所述触按特征包括被设置为靠近所述接收杯的近侧端的隆起和被设置在所述接收杯的远侧部分之上并且围绕所述接收杯的所述远侧部分弯曲的脊;以及
阀/密封件组件,所述阀/密封件组件被设置在所述管道中,使得所述导管能够通过所述管道。
2.如权利要求1所述的进入端口,其中所述管道包括第一管道部分和第二管道部分,所述第二管道部分被安置在所述第一管道部分的远侧并且相对于所述第一管道部分以成角度的取向被安置,以便在允许所述导管通过的同时阻止所述承载导管的针中的所述针的通过。
3.如权利要求2所述的进入端口,其中所述第二管道部分相对于所述第一管道部分以小于37度的角度被设置。
4.如权利要求1所述的进入端口,其中当所述进入端口被皮下植入时,所述接收杯被安置为基本上平行于所述皮肤表面。
5.如权利要求4所述的进入端口,其中被基本上正交插入通过所述患者的所述皮肤的针能够碰击所述进入端口的所述接收杯。
6.如权利要求1所述的进入端口,其中所述管道从所述接收杯延伸到所述进入端口的导杆的出口。
7.如权利要求1所述的进入端口,其中所述进入端口的所述本体绕所述接收杯基本上限定三角形。
8.如权利要求1所述的进入端口,其中所述阀/密封件组件包括相对于彼此以夹层配置安置的第一密封件、第一裂隙阀和第二裂隙阀。
9.如权利要求1所述的进入端口,其中所述接收杯的至少一部分包括针不能穿过的材料。
10.如权利要求9所述的进入端口,其中所述针不能穿过的材料包括金属、玻璃和陶瓷中的至少一种。
11.如权利要求1所述的进入端口,其中所述本体包括金属和热塑性塑料中的至少一种。
12.如权利要求11所述的进入端口,其中所述本体的至少一部分包括钛和乙酰树脂中的至少一种。
13.如权利要求12所述的进入端口,其中所述入口端口在所述接收杯中基本上位于中心。
14.如权利要求1所述的进入端口,其中所述本体限定至少第一和第二接收杯,每个接收杯经由入口端口与管道连通,每条管道具有被设置在所述管道中的阀/密封件组件。
15.一种用于制造用于在患者体中皮下放置的低轮廓进入端口的方法,所述方法包括:
提供所述进入端口的第一本体部分和第二本体部分,所述第一本体部分限定一部分管道,所述管道包括在所述管道的近侧端的入口端口,所述第一本体部分还限定与所述入口端口连通的接收杯,所述接收杯成凹形且包括引导槽以将承载导管的针的碰击的远侧末端经由所述入口端口引导到所述管道,所述引导槽与所述入口端口纵向对准,所述接收杯被配置,以便在所述患者体内被皮下植入时朝向皮肤表面取向;
提供触按特征,其用于在植入患者的皮肤下之后辅助临床医生经由手指触按来定位和/或识别所述低轮廓进入端口,所述触按特征包括被设置为靠近所述接收杯的近侧端的隆起和被设置在所述接收杯的远侧部分之上并且围绕所述接收杯的所述远侧部分弯曲的脊;
将阀/密封件组件放置在所述一部分管道;以及
将所述进入端口的所述第二本体部分接合到所述第一本体部分,以便将所述阀/密封件组件夹在所述第一本体部分和所述第二本体部分之间,所述第二本体部分包括导杆,所述导杆为所述管道提供流体出口。
16.一种用于在患者体中皮下放置的低轮廓进入端口,所述进入端口包括:
本体,所述本体包括:
管道,所述管道包括在所述管道的近侧端的入口端口;
与所述入口端口连通的接收杯,所述接收杯成凹形以将承载导管的针经由所述入口端口引导到所述管道;
引导槽,所述引导槽被限定在所述接收杯中且与所述入口端口纵向对准,以将所述承载导管的针的远侧末端朝向所述入口端口引导;以及
触按特征,其用于在植入患者的皮肤下之后辅助临床医生经由手指触按来定位和/或识别所述低轮廓进入端口,所述触按特征包括被设置为靠近所述接收杯的近侧端的隆起和被设置在所述接收杯的远侧部分之上并且围绕所述接收杯的所述远侧部分弯曲的脊;以及
阀/密封件组件,所述阀/密封件组件被设置在所述管道中,使得所述导管能够通过所述管道,并且所述阀/密封件组件包括用于阻止通过所述阀/密封件组件的回流的至少一个密封件。
17.如权利要求16所述的进入端口,其中所述至少一个密封件限定通过所述至少一个密封件的中心孔,并且其中所述密封件的远侧面包括绕所述中心孔设置的截头圆锥形的部分,用于当流体在压力下通过所述导管时阻止通过所述导管的回流。
18.如权利要求17所述的进入端口,其中所述接收杯在所述患者体内被皮下植入时基本上朝向皮肤表面取向,并且其中顺从性包覆模制的部分覆盖所述进入端口的所述本体的至少一部分。
19.如权利要求18所述的进入端口,其中所述包覆模制的部分包括至少一个预先确定的区域,缝合线能够通过所述区域以将所述进入端口固定到所述患者的组织。
20.如权利要求19所述的进入端口,其中所述阀/密封件组件还包括夹在所述至少一个密封件和第二密封件之间的第一和第二裂隙阀。
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CN108079432A (zh) | 2018-05-29 |
US10463845B2 (en) | 2019-11-05 |
CN108079432B (zh) | 2021-08-03 |
CA2897214A1 (en) | 2014-07-31 |
JP2016504158A (ja) | 2016-02-12 |
EP2948121A1 (en) | 2015-12-02 |
JP6795639B2 (ja) | 2020-12-02 |
BR112015017424B1 (pt) | 2022-01-18 |
EP3342391A1 (en) | 2018-07-04 |
US20140207086A1 (en) | 2014-07-24 |
ES2659372T3 (es) | 2018-03-15 |
JP2019107472A (ja) | 2019-07-04 |
EP2948121B1 (en) | 2017-11-29 |
BR112015017424A2 (pt) | 2017-07-11 |
CN104936571A (zh) | 2015-09-23 |
JP6487339B2 (ja) | 2019-03-20 |
CA2897214C (en) | 2022-04-05 |
WO2014116810A1 (en) | 2014-07-31 |
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