CN101011297B - 注射端口 - Google Patents

注射端口 Download PDF

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CN101011297B
CN101011297B CN200710006944XA CN200710006944A CN101011297B CN 101011297 B CN101011297 B CN 101011297B CN 200710006944X A CN200710006944X A CN 200710006944XA CN 200710006944 A CN200710006944 A CN 200710006944A CN 101011297 B CN101011297 B CN 101011297B
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CN101011297A (zh
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R·T·拜拉姆
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Ethicon Endo Surgery Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/005Gastric bands
    • A61F5/0053Gastric bands remotely adjustable
    • A61F5/0056Gastric bands remotely adjustable using injection ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0208Subcutaneous access sites for injecting or removing fluids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0036Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
    • A61M2039/0072Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions

Abstract

可与胃束带组件一起使用的端口,具有隔膜,该隔膜经受多方向压缩力,以便辅助密封由多次针刺引起的不完整处。包括轴向压缩力和径向压缩力的多方向压缩力可通过提供锥形隔膜来产生。还可通过提供用于将隔膜插入端口主体的倾斜引入部分来产生这种多方向压缩力。

Description

注射端口
技术领域
本发明总的涉及医疗植入物和施放器,并且更具体地说是涉及与多种医疗植入物和施放器一起使用的注射端口。将结合外科可植入注射端口及其施放器描述本发明,但本发明不限于此。
背景技术
注射端口通常放置在患者皮肤下方,并具有多种用途,例如,注射药物、抽血以及调节胃束带。从20世纪80年初期开始,可调节胃束带为胃旁路术和其它用于病理性肥胖病人的不可逆外科减肥治疗提供了有效的替代方式。胃束带通常围绕患者的胃的上部卷绕,从而形成一个人造开口,该人造开口限制食物从胃的上部运动到下部。当胃束带放置就位,且该人造开口的尺寸适当时,保持在胃上部中的食物提供了阻止过度进食的饱胀感。但是,胃束带最初调节的不适当或者一段时间后胃的变化会导致人造开口的尺寸不合适,这就需要调节胃束带。例如,如果人造开口太小而不能合理的通过食物,患者可能会呕吐并且不舒服。如果人造开口太大,并且没能减慢食物从胃的上部运动到下部,则需要将胃束带束紧。
通常用可向内扩张的囊调节胃束带,该囊类似于血压袖带,在其中可注入流体,例如盐水。需要采用可用于实现所需直径的流体注射端口频繁地将流体等注射到可扩张囊中。由于可调节胃束带通常在患者体内保持很长一段时间,流体注射端口典型地被安装在皮下,以避免感染。通常通过将休伯针穿过皮肤插入注射端口的硅树脂隔膜来实现在可调节胃束带中的流体量的调节。一旦移出针,隔膜会密封该孔。柔性导管连通注射端口和可调节胃束带。
所述硅树脂隔膜通常能够部分自修复,从而在该隔膜变得无效之前可多次插入针。通常通过在使隔膜和注射端口组装时对隔膜施加轴向压缩载荷来实现自修复特征。通常通过在组装过程中将隔膜夹在两个相邻件之间来获得该轴向力。从而在整个手术持续期间以压缩的方式加载隔膜。
尽管在多次针刺之后隔膜还具有自修复的能力,但是,部分地由于轴向压缩载荷无法再次密封不完整处,在隔膜持续受到穿刺时这种能力开始退化。由于注射端口通常是可植入的,胃束带手术等不得不被缩短或中断,以便移出和/或更换其中隔膜已变得不那么有效或无效的注射端口。这种手术会增加患者和医院的费用,并且如果外科手术需要移除注射端口,患者会受到健康危险。另外,如果在隔膜失去完整性时流体等扩散或者泄露,则胃束带等会变得不那么有效。
因此,提供一种具有更长使用寿命的隔膜将是有利的。提供一种如下所述的隔膜是更加有利的,该隔膜在多次针刺之后能有效地再密封,并且能够使用传统组装机构更简单地组装。
发明内容
本发明公开了一种包括胃束带和注射端口的胃束带组件,其中,注射端口用传输部分连接到胃束带。所述注射端口包括隔膜保持器,该隔膜保持器具有基座和套环。所述胃束带组件还包括隔膜,其中,所述隔膜包括锥形表面,该表面在操作上构造为与隔膜保持器接合,从而在隔膜被容纳在隔膜保持器中时使多方向的压缩力施加在该隔膜上。
本发明公开了一种端口,该端口包括具有隔膜保持器的端口主体。所述端口还包括隔膜,其中所述隔膜包括锥形表面,该表面在操作上构造为与隔膜保持器接合,从而在隔膜被容纳在隔膜保持器中时使多方向的压缩力施加在该隔膜上。
本发明公开了一种端口,该端口包括具有隔膜保持器的端口主体,其中所述隔膜保持器包括基座和套环。所述端口还包括隔膜,在组装该隔膜保持器时将所述隔膜保持在基座和套环中,从而使多方向的压缩力施加在该隔膜上。
更具体地说,本发明涉及如下内容:
(1)一种端口,包括:
(a)在其中具有隔膜保持器的端口主体;以及
(b)隔膜,其中所述隔膜包括锥形表面,该表面在操作上能够与所述隔膜保持器接合,从而在所述隔膜被容纳在所述隔膜保持器中时使多方向的压缩力施加在所述隔膜上。
(2)如第(1)项所述的端口,其中,所述隔膜由弹性材料构造而成。
(3)如第(2)项所述的端口,其中,所述隔膜由硅树脂构造而成。
(4)如第(1)项所述的端口,其中,所述隔膜保持器还包括对应于所述隔膜的所述倾斜表面的倾斜表面。
(5)如第(1)项所述的端口,其中,所述多方向的压缩力为施加到所述隔膜上的轴向压缩力和径向压缩力,从而使由针刺导致的不完整基本上自修复。
(6)如第(1)项所述的端口,其中,所述隔膜保持器还包括套环和基座,所述套环和所述基座被连接成将所述隔膜压缩在其中。
(7)如第(1)项所述的端口,其中,通过用橡实压机连接所述隔膜和所述隔膜保持器来产生多方向压缩力。
(8)一种端口,包括:
(a)端口主体;
(b)容纳在所述端口主体内的隔膜保持器,其中所述隔膜保持器包括基座和套环;以及
(c)隔膜,其中在组装所述隔膜保持器时将所述隔膜保持在所述基座和所述套环中,从而使多方向的压缩力施加在所述隔膜上。
(9)如第(8)项所述的端口,其中,所述隔膜由弹性材料构造而成。
(10)如第(9)项所述的端口,其中,所述隔膜由硅树脂构造而成。
(11)如第(8)项所述的端口,其中,所述隔膜的初始直径大于在所述隔膜保持器中的内腔的直径,将该隔膜压入所述内腔中能够产生作用在该隔膜上的径向压缩力。
(12)如第(11)项所述的端口,其中,所述隔膜的初始高度大于在所述基座和所述套环的环形边缘之间的内腔的高度,其中连接所述基座和套环能够压缩所述隔膜,从而产生作用于该隔膜的轴向压缩力。
(13)如第(11)项所述的端口,其中,所述套环还包括倾斜的引入部分,该引入部分在操作上能够将所述隔膜插入所述内腔,并使其受到压缩。
(14)如第(13)项所述的端口,其中,通过用橡实压机连接所述隔膜保持器和所述隔膜。
(15)如第(11)项所述的端口,其中,通过用橡实压机连接所述隔膜保持器和所述隔膜。
(16)如第(8)项所述的端口,其中,所述多方向的压缩力为轴向压缩力和径向压缩力。
(17)一种胃束带组件,包括:
(a)胃束带;
(b)注射端口,其中用设置在其间的传输部分将该注射端口连接到所述胃束带;
(c)容纳在所述注射端口中的隔膜保持器,其中所述隔膜保持器包括基座和套环;以及
(d)隔膜,其中,所述隔膜包括锥形表面,该表面在操作上能够与隔膜保持器接合,从而在隔膜被容纳在隔膜保持器中时使多方向的压缩力施加在所述隔膜上。
(18)如第(17)项所述的胃束带组件,其中,所述多方向的压缩力包括轴向压缩力和径向压缩力。
(19)如第(18)项所述的胃束带组件,其中,所述隔膜由硅树脂构造而成。
(20)如第(19)项所述的胃束带组件,其中,所述倾斜表面包括至少两个不同的角度。
附图说明
结合到本说明书中并作为其中一部分的附图显示了本发明的实施方式,并且,其与上述本发明的总体说明和下面对实施方式的详细说明一起用于阐述本发明的原理。
图1是围绕胃放置的胃束带的周围环境图,其中一个注射端口连接到该胃束带;
图2是图1的注射端口的透视图,带有能够容纳隔膜的端口主体;
图3是沿着图2的注射端口的线3-3截取的主剖视图;
图4是示出了插入隔膜前沿着可选的注射端口的线3-3截取的主剖视图;以及
图5是沿着图4的注射端口的线3-3截取的主剖视图,其中显示隔膜已经插入并在其中受到压缩。
下面将详细介绍本发明的优选实施方式,在附图中显示了其中一个例子。
具体实施方式
在下面的说明中,在各幅附图中用相同的附图标记代表相同或者相应的零部件。同样,在下面的说明中,应当理解的是,诸如前、后、内、外等的术语是为了方便而采用的词语,不能理解为限制术语。本文中使用的术语并不是要限制在此处描述的装置的范围内,或者其一部分,可以以其它方位连接或使用。下面将更详细地参照附图说明本发明的实施方式。
参照图1,其中示出了胃束带组件6的一种形式的周围环境图,具有通过传输部分13连接到注射端口10的胃束带8。胃束带8可围绕患者的胃9放置,从而借助注射端口10进行的流体等的输送或移除将调解通过胃束带8产生的人造口的尺寸。可诸如通过将注射端口10固定到患者的肌肉组织来将注射端口10保持在患者体内,从而可通过将休伯针等插入患者和注射端口10来实现进入胃束带组件。
参照图2,可植入注射端口10具有端口主体11和传输部分13,端口主体11能够在其中容纳隔膜16。此处描述的隔膜16和端口主体11的形式可与任何合适的端口或者传输部件一起使用,例如在2003年12月19日提交的、名称为“Subcutaneous Self Attaching InjectionPort With Integral Moveable Retention Members”的共同未审结的美国专利申请序列号10/741,875中公开的那些,该文献的全文通过引用结合入本文,并且结合的程度不限制本发明的范围。另外,本申请通过引用结合下述均为2003年12月19日提交的美国专利申请,并且结合的程度不限制本发明:申请序列号No.10/741,127,名称为“Subcutaneous Injection Port For Applied Fasteners”;申请序列号No.10/741,875,名称为“Subcutaneous Self Attaching Inj ection Port WithIntegral Moveable Retention Members”;申请序列号No.10/741,868,名称为“Subcutaneous Self Attaching Inj ection Port With IntegralFasteners”。应当理解的是,隔膜16可与任何其可适用的可植入医疗装置一起使用,例如包括起搏器、脉管进入端口、诸如与胃束带一起使用的注射端口以及胃起搏装置。
参照图3,端口主体11包括隔膜保持器14,其构造为大致环形的带,并包括基座17和套环19,它们在操作上构造为在其中保持隔膜16。在被连接时,隔膜保持器14的基座17和套环19可以在操作上构造成为隔膜16提供径向和轴向压缩力。套环19还包括环形边缘15,在被保持在隔膜保持器14的内腔25中时隔膜16通过该环形边缘15凸出。
在一种形式中,如图3所示,隔膜16为具有底面32、顶面34和锥形表面40的大致圆锥形盘。该隔膜16可从底面32向顶面34逐渐变尖,其中例如底面32的直径大于顶面34的直径。在一种形式中,通过使隔膜16变尖并且将套环19构造出相应的斜度,在组装过程中套环19向内推压时隔膜16会受到径向压缩。这种向内压缩会产生径向压缩,在隔膜16被针刺后该径向压缩会有利地重新密封不完整处。在一种形式中,隔膜16包括不是锥形的基座36,其中该基座可被构造成直接地放置在基座17的环形平面18上,以进行支撑。隔膜16最初可以比内腔25大,从而在基座17和套环19组装时必须压缩该隔膜以装配入该内腔。可通过在环形边缘15和环形平面18之间压缩隔膜16来产生轴向压缩。
应当理解的是,隔膜16可由任何合适的生物相容性材料(例如硅树脂)构造而成。由底面34和倾斜表面40的矢量限定的倾斜角α可以从大约10度到大约80度、从大约20度到大约70度、从大约30度到大约60度、从大约55度到大约70度、在大约65度和/或在任何其它合适的角度。在一种形式中,隔膜16可设有多个角度变量,从而使不同水平的径向和/或轴向压缩力作用于隔膜16。例如,在隔膜底面处的倾斜角可以是65度,而朝着顶面的倾斜角可以是70度。还可以想到的是,倾斜角可以逐渐地变化和/或倾斜角包括一系列角度变化,在这些角度变化之间的角度保持恒定。
参照图4-5,其中示出了一种可选形式的端口主体111,其在操作上构造为向隔膜116施加多方向压缩力,例如轴向和径向压缩力。端口主体111包括隔膜保持器114,其中隔膜保持器114为大致环形元件,包括基座117和套环119,它们在操作上构造为在其中保持隔膜116。在被连接时,隔膜保持器114的基座117和套环119可以在操作上构造成向隔膜116施加径向和轴向压缩力。套环119还包括环形边缘115,隔膜116通过该环形边缘115凸出。
在一种形式中,隔膜116为具有底面132、顶面134的大致环形盘,其由弹性材料(例如硅树脂)构造而成。该隔膜116可被构造成其直径在插入前比内腔125的直径大。套环119可设有成一定角度的引入部分150,该引入部分150在操作上构造成沿径向加压隔膜116,并且在组装过程中便于将隔膜插入内腔125。在隔膜116被插入时,其受到成一定角度的引入部分150的压缩,直到它牢固地装配到内腔125的减小的直径中。由于弹性材料试图抵抗套环119扩张,弹性隔膜116的插入会导致其中的径向压缩。隔膜116的径向压缩可便于在一次或多次针刺后的重新密封。
除了径向压缩,可通过将基座117与隔膜保持器114的套环119相连来施加轴向压缩。例如,在组装过程中隔膜116可在基座117上的环形平面118和套环119的环形边缘115之间受到轴向压缩。隔膜116可以被构造成,在连接基座117和套环119时其弹性材料受到压缩和保持,由此在其中产生轴向压缩力。例如,隔膜116的初始高度可大于在连接时基座117和套环119之间的距离。在示出的形式中,可同时产生轴向和径向压缩力,以改进隔膜116的重新密封性。提供多种压缩力可以重新密封那些在只提供单方向力时不能密封的缺陷等。
应该理解的是,隔膜116可由任何合适的生物相容性和/或弹性材料(例如硅树脂)构造而成。还应该理解的是,隔膜116可包括倾斜表面。套环119可包括任何合适的成一定角度的引入部分150,该引入部分150具有适合于方便将隔膜116插入隔膜保持器114的角度。还可以想到的是,例如,在插入之前使隔膜116受到预压缩,在插入到套环119中时使隔膜116上的预压缩释放,从而使隔膜116挤压隔膜保持器114的侧面。
同时提供多方向的压缩力(例如沿径向和轴向的压缩力)可增加隔膜在变得不那么有效或者无效之前可被针等刺的次数。增加隔膜的寿命可增加注射端口和/或一起使用的医疗装置的寿命。增加注射端口的寿命可增加手术和与该注射端口一起使用的器械的效率、安全性和/或准确性。
应该理解的是,可通过任何合适的装置提供任何合适的多方向力,以便于改进在针刺之后隔膜的自修复。例如,可通过用适于施加轴向压力的简单的手扳压机连接隔膜和隔膜保持器来获得多方向压缩力。可通过在隔膜和隔膜保持器接合时实现径向压缩力的手扳压机的轴向力获得多方向压缩力。诸如轴向压缩力和径向的压缩力的多方向力可同时实现或相继实现。例如,在一种形式中,当用橡实压机(acorn press)等组装时隔膜和隔膜保持器会受到轴向压缩。然后可通过为隔膜保持器设置围绕其圆周的环形带来实现径向压缩,其中,除了橡实压机产生的轴向压缩力之外,所述环形带在调节时向隔膜施加径向压力。
应该理解的是,隔膜和/或隔膜保持器可构造为施加任何合适水平的单方向的或多方向的压缩力。例如,可通过下述方式产生或改变多方向力,即调节隔膜锥形的角度、为该锥形设置变化的角度、调节隔膜保持器锥形的角度、调节环形平面的形状或尺寸、改变隔膜的尺寸、改变成一定角度的引入部分的形状和/或增加径向压缩带(未示出)。隔膜保持器、端口主体和/或任何其它元件可由具有足够硬度和强度的任何合适材料制成,例如聚醚醚酮(已知为PEEK)。
尽管此处已经示出和描述了本发明的优选实施方式,但是,对于本领域技术人员很明显的是,这些实施方式仅仅是通过例子的方式给出的。在不背离所附权利要求的精神和范围的条件下,本领域技术人员可想到各种变化、改变和替代。另外,所描述的关于本发明的每个元件可以可选地描述为用于执行该元件功能的部件。
例如,对于本领域技术人员将变得很显然的是,得益于本公开内容,上述发明同样适用于其它类型的可植入束带。例如,用于治疗大便失禁的束带。在美国专利6,461,292中描述了这样一种束带,该文献通过引用结合入本文。还可以是用于治疗小便失禁的束带。在美国专利申请2003/0105385中描述了这样一种束带,该文献通过引用结合入本文。还可以是用于治疗胃灼热和/或胃酸回流的束带。美国专利6,470,892中描述了这样一种束带,该文献通过引用结合入本文。还可以是用于治疗阳痿的束带。美国专利申请2003/0114729中描述了这样一种束带,该文献通过引用结合入本文。另外,可液力扩张治疗构件可包括外部的可调节囊,通过扩张长度和/或外径来致动所述囊,例如阴茎植入物。

Claims (5)

1.一种端口,包括:
(a)端口主体,在所述端口主体中具有隔膜保持器,所述隔膜保持器包括套环和隔膜保持器基座,其中所述套环具有倾斜内表面,并且所述隔膜保持器基座具有内表面和在与所述套环接合时与所述套环的倾斜内表面相配合的倾斜外表面;以及
(b)隔膜,其中所述隔膜包括不是锥形的隔膜基座和从所述隔膜基座延伸的锥形部分,其中所述隔膜基座直接放置在所述隔膜保持器基座的内表面上,所述套环的倾斜内表面与所述隔膜的锥形部分接合,所述隔膜通过所述隔膜与所述套环和隔膜保持器基座的接合以及所述套环和隔膜保持器基座的接合而受到保持和压缩,从而在所述隔膜被容纳在所述隔膜保持器中时使多方向的压缩力施加在所述隔膜上。
2.如权利要求1所述的端口,其中,所述隔膜由弹性材料构造而成。
3.如权利要求2所述的端口,其中,所述隔膜由硅树脂构造而成。
4.如权利要求1所述的端口,其中,所述多方向的压缩力为施加到所述隔膜上的轴向压缩力和径向压缩力,从而使由针刺导致的不完整基本上自修复。
5.如权利要求1所述的端口,其中,通过用橡实压机连接所述隔膜和所述隔膜保持器来产生多方向压缩力。
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US20070185462A1 (en) 2007-08-09
JP5095233B2 (ja) 2012-12-12
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ES2333625T3 (es) 2010-02-24
DE602007003113D1 (de) 2009-12-24
EP1815881B2 (en) 2015-10-28
US7762999B2 (en) 2010-07-27
CA2575626A1 (en) 2007-08-01
ES2333625T5 (es) 2016-01-22
AU2007200121A1 (en) 2007-08-16
MX2007001260A (es) 2009-02-12
CA2575626C (en) 2015-07-14
HK1106730A1 (en) 2008-03-20
BRPI0700167A (pt) 2007-11-06
BRPI0700167B8 (pt) 2021-06-22
CN101011297A (zh) 2007-08-08
EP1815881B1 (en) 2009-11-11
ATE447997T1 (de) 2009-11-15
JP2007203070A (ja) 2007-08-16
EP1815881A1 (en) 2007-08-08

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