CN115103702A - 配备有组织长入套管的外部终端装置 - Google Patents
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Abstract
一种外部终端装置,其具有壳体(4),该壳体包括基部(5),其中形成有远侧开口(12),该远侧开口接收具有管柱(140)的漏斗形隔件(14)。在管柱(140)内,导管(3)连接到安装件(15)的远侧部分(16)。管状包层(2)具有适于移植到管柱(140)上的近侧端部和同轴地粘附到导管(3)的远侧端部。组织长入材料的一对带(90、91)固定在管状包层(2)上,并且配备有锚固装置的锚固环(92)夹在带(90、91)之间。
Description
技术领域
本发明涉及一种可用于例如血液透析、腹膜透析和化学疗法中的外部终端装置。该外部终端装置配备有组织长入套管(tissue-ingrowth cuff)。
背景技术
定位在永久性中心静脉导管上的目前的套管包括粘在导管本身上的涤纶带,并且具有机械功能和生物功能。
从机械的角度来看,通常是环形垫的这些套管是身体外部的材料制成的。当被定位在皮下组织中时,套管被结合到身体中,即使产生倾向于将它们与周围组织隔离的反应。结果是形成了疤痕组织,该疤痕组织渗入涤纶本身的细丝中,有效地将其阻挡在该位置,最终获得了将套管固定在适当位置的粘附力,防止其向外滑动并且从而避免了导管本身的意外排出。
从生物学的角度来看,这种疤痕组织同时形成了一种屏障,阻碍细菌菌落沿着导管所在的皮下隧道的行进,该细菌菌落不可避免地会到达导管的浸入到血液中的部分并引起感染,首先是局部的,并且然后是全身性的感染。
然而,所有这些都非常受限于套管的小尺寸,在现有技术中,套管通常不是很宽。它们的小宽度还导致随着时间的推移,由于对使用这些导管的患者的护士护理,疤痕组织的形成逐渐产生,失去其机械功能,随后导致导管的释放及其排出。
US 2012/0209206 A1公开了一种组织长入套管,用于稳定植入的导管以防止移动。套管一旦移动到其所需位置就由外科医生致动,以抓住导管。套管包括两个本体部分,这两个本体部分在联接之前可沿导管单独地滑动,但可通过互补的抓握部分围绕导管彼此附接。在导管植入后,组织长入材料在皮下隧道内固定到套管的朝外的表面,从而锚固导管以防止移动。
引用文献中描述的套管具有能够定位在外科医生期望的位置的优点。然而,套管的锚固仅依靠它周围的长入的组织。
发明内容
本发明的一个目的是避免连接到外部终端装置的导管从外科医生安装它的皮下隧道中的位置移位。
该目的通过配备有组织长入套管的外部终端装置来实现,如所附权利要求所定义。
有利地,根据本发明的套管包括两个不同的涤纶带,而不是仅一个。
与当今市场上的导管相比,涤纶带的宽度相当可观。正如很容易理解的那样,这已经大大增加了套管本身的机械抓握。
从生物学的角度来看,很明显,这种相当大的宽度也会对细菌的行进产生更大的障碍,细菌因此必须行进很长的路径才能克服它并到达导管的浸入血液中的部分。
在两个带之间具有刚性聚砜(polysulfone)环,该刚性聚砜环在底部配备有呈45°角的钩形的两个小突起。该两个小突起在植入时由于从外部对其施加的简单且轻微的压力而被锚固到下面的肌肉带上:这加强并稳定了套管本身的机械抓握。
附图说明
在借助附图以非限制性示例的方式示出的外部终端装置的一个优选但非排他性的实施例的本描述中,进一步的特征和优点将变得最明显,在附图中:
图1示出了根据本发明的装置的一个实施例处于关闭位置的整体立体图;
图2是图1中的装置的俯视图;
图3是图1中的装置的侧视图;
图4示出了图1中的装置的俯视图,没有覆盖元件和关闭盖;和
图5是图1中的装置的分解立体图。
具体实施方式
参考图1,该图是根据本发明的外部终端装置的一个实施例的总轴测图,该外部终端装置处于关闭位置,即未连接到血液处理机的流动管线。通常表示为1的外部终端装置被结合到被植入患者内的两腔导管。如下文将详细解释的,表示为3的导管能够穿过管状包层2,该管状包层2适于将终端装置锚固在患者外部。
还参照图2至图4,其分别示出了图1中的外部终端装置1的俯视图、侧视图和远侧端视图,该外部终端装置1包括壳体4,壳体4包括基座5和可拆卸的覆盖件6,所述可拆卸的覆盖件用通常由7指示的螺钉固定到基座5。在基座5中一体形成有两个环8,其用于将外部终端装置1缝合到患者的皮肤上。壳体4由盖10封闭。
还参考图5,其是外部终端装置1的分解立体图,壳体4被显示为由盖10封闭,其中插入了抗菌海绵21。盖10具有远侧突起22、22,其端部接合在可拆卸覆盖件6中的用23表示的相应凹部和在壳体4的基座5的底壁中外部形成的类似凹部(未示出)。
基座5具有侧壁50,可拆卸覆盖件6通过螺钉7固定在侧壁50上,其中插入垫圈11。基座5具有相对于用于血液透析的治疗设备的流动管线(未示出)的远侧开口12,以及一对近端开口13、13。
远侧开口12和近侧开口13、13在三侧上由凹槽界定,该凹槽适于形成用于插入隔件的引导。特别地,如图5所示,远侧开口12提供用于插入隔件14,如下文将看到的。
容纳在壳体4中的安装件15具有与导管3接合的远侧管道16和两个近侧管道17、17。一对弯管18、18中的每个管具有插入到安装件15的相应近侧管道17上的远侧端部180和近侧端部181。一对管嘴190、190被插入弯管18、18的近侧端部181、181中。远侧开口12接收包括管柱140的漏斗形隔件14,导管3在管柱140内被连接到安装件15的远侧管道16。管状包层2具有能够接合到管柱140上的近侧端部和同轴地粘附到导管3的远侧端部。组织长入材料(tissue-ingrowth material)的一对带90、91被固定在管状包层2上,并且配备有锚固装置的锚固环92夹在带90、91之间。
锚固装置包括两个尖突起93、93,优选为钩状,从环92面向外。尖突起93、93有利地相对于彼此成45°角并且关于患者的皮肤面向相对的位置。优选地,大于1cm宽的带90、91由涤纶制成,而锚固环92由聚砜制成。
导管3穿过隔件14的管柱140,以钩到位于基座5内的安装件15。安装件15的远侧管道16通常是插入导管3中的两腔导管部分。安装件15的两个近侧管道17、17插入弯管18、18的远侧端部180中。在弯管18、18的近侧端部181中被插入的是管嘴190、190,管嘴190、190被接收在用于被保持在壳体4的壁50的近侧开口13、13中的穿通隔件19、19中。
Claims (6)
1.一种配备有组织长入套管的外部终端装置,该外部终端装置适于在一侧连接到导管(3),并且在另一侧连接到盖(10)或可替代地连接到治疗设备的流动管线,所述外部终端装置包括:
-壳体(4),其包括基座(5)、多个侧壁(50)以及在侧壁(50)上的可拆卸盖(6),所述多个侧壁(50)设置有远侧开口(12)和相对于所述流动管线的一对近侧开口(13、13),
-安装件(15),其容纳在壳体(4)中并具有两个近侧管道(17、17)和与导管(3)接合的远侧管道(16),
-一对弯管(18、18),每个弯管具有远侧端部(180)和近侧端部(181),所述远侧端部(180)被插在安装件(15)的相应近侧管道(17)上,和
-一对管嘴(190、190),其被插入弯管(18、18)的近侧端部(181、181)内,
所述壳体(4)的所述远侧开口(12)接收包括管柱(140)的漏斗隔件(14),导管(3)在管柱内被连接到安装件(15)的远侧管道(16),管状包层(2)具有适于插入在管柱(140)上的近侧端部和同轴地粘附于所述导管(3)的远侧端部,
其特征在于
-组织长入材料的一对带(90、91)被附接在管状包层(2)上,以及
-配备有锚固装置的锚固环(92)被夹在所述带(90、91)之间。
2.根据权利要求1所述的装置,其特征在于,所述锚固装置包括从所述环(92)面向外的两个钩尖突起(93、93)。
3.根据权利要求2所述的装置,其特征在于,所述钩尖突起(93、93)彼此成45°角。
4.根据权利要求1所述的装置,其特征在于,所述带(90、91)由涤纶制成。
5.根据权利要求1所述的装置,其特征在于,所述一对带(90、91)中的每个带具有大于1cm的宽度。
6.根据权利要求1所述的装置,其特征在于,所述锚固环(92)由聚砜制成。
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IT102020000000577A IT202000000577A1 (it) | 2020-01-14 | 2020-01-14 | Dispositivo terminale esterno dotato di cuffia a crescita tissutale |
IT102020000000577 | 2020-01-14 | ||
PCT/IB2021/050231 WO2021144715A1 (en) | 2020-01-14 | 2021-01-13 | External end device equipped with a tissue-ingrowth cuff |
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US20070078478A1 (en) * | 2005-07-27 | 2007-04-05 | Atkins Joseph R | Catheter and tunneling device therefor |
US7753889B2 (en) * | 2007-06-15 | 2010-07-13 | Interrad Medical, Inc. | Anchor instrumentation and methods |
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2020
- 2020-01-14 IT IT102020000000577A patent/IT202000000577A1/it unknown
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2021
- 2021-01-13 EP EP21701594.0A patent/EP4090406B1/en active Active
- 2021-01-13 WO PCT/IB2021/050231 patent/WO2021144715A1/en unknown
- 2021-01-13 JP JP2022567706A patent/JP2023512597A/ja active Pending
- 2021-01-13 BR BR112022013935A patent/BR112022013935A2/pt unknown
- 2021-01-13 CN CN202180009375.2A patent/CN115103702A/zh active Pending
- 2021-01-13 US US17/758,878 patent/US20230033670A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
EP4090406A1 (en) | 2022-11-23 |
US20230033670A1 (en) | 2023-02-02 |
EP4090406B1 (en) | 2024-01-10 |
IT202000000577A1 (it) | 2021-07-14 |
BR112022013935A2 (pt) | 2022-10-11 |
JP2023512597A (ja) | 2023-03-27 |
EP4090406C0 (en) | 2024-01-10 |
WO2021144715A1 (en) | 2021-07-22 |
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