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CN102612343B - 包括锚定装置和标识部分的包覆模制的进入端口 - Google Patents

包括锚定装置和标识部分的包覆模制的进入端口 Download PDF

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CN102612343B
CN102612343B CN201080051911.7A CN201080051911A CN102612343B CN 102612343 B CN102612343 B CN 102612343B CN 201080051911 A CN201080051911 A CN 201080051911A CN 102612343 B CN102612343 B CN 102612343B
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CN102612343A (zh
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M·威利
J·L·诺伊斯
D·M·西斯
W·R·巴伦
K·J·克里斯琴
A·欧罗密
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CR Bard Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0009—Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0036—Tubes, 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
    • A61M2039/0081—Means for facilitating introduction of a needle in the septum, e.g. guides, special construction of septum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M2039/0205—Access sites for injecting media
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0223—Subcutaneous access sites for injecting or removing fluids having means for anchoring the subcutaneous access site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0238—Subcutaneous access sites for injecting or removing fluids having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining

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  • Health & Medical Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

公开了一种用于提供对患者皮下进入的进入端口。在一个实施方案中，所述端口包括限定经过间隔件可进入的流体腔的内部本体。包括有机硅的顺从性外罩体绕所述本体的至少一部分被设置。凸缘与所述端口本体一起被包括并且由所述外罩体覆盖。所述凸缘绕邻近所述间隔件的所述端口本体的周缘径向地延伸，从而在针偏离所述间隔件的情况下阻止所述针实质性地穿入所述外罩体。所述凸缘还可以包括锚定装置和标识部分这二者，所述锚定装置用于将所述外罩体固定到所述端口本体，所述标识部分通过X-射线成像技术是可见的，用于传达所述进入端口的至少一个属性的信息指示。所述外罩体提供施用抗微生物/抗血栓形成覆层的适合的表面。

Description

包括锚定装置和标识部分的包覆模制的进入端口
相关申请的交叉引用：本申请要求2009年11月17日递交的、题目为“包括锚定标识部分的可植入的包覆模制的进入端口(ImplantableOvermoldedAccessPortIncludingAnchoringIdentificationFeature)”的美国临时专利申请No.61/262,126的优先权，该申请通过引用被整体并入本文。
发明内容
简要概述，本发明的实施方案涉及用于提供对患者皮下进入的进入端口。具体地，在一种实施方式中，进入端口被植入患者体内，然后与已经被插入患者脉管系统的导管流体地连接。经这样的安置和配置，进入端口可以由针或其他输注/抽吸装置经皮地进入，从而经过端口和导管给药至患者脉管系统，或者从患者脉管系统抽吸血液或其他流体。
在一个实施方案中，端口包括限定经过间隔件可进入的流体腔的内部本体。包括有机硅的顺从性(compliant)外罩体绕所述本体的至少一部分被设置。凸缘与所述端口本体一起被包括并且由所述外罩体覆盖。所述凸缘绕邻近所述间隔件的所述端口本体的周缘径向地延伸，从而例如当针试图进入所述端口而偏离(miss)所述间隔件的情况下阻止所述针穿入所述外罩体一实质性距离。
在一个实施方案中，进入端口的凸缘还可以包括锚定装置和标识部分这二者，所述锚定装置用于将所述外罩体固定到所述端口本体，所述标识部分通过X-射线成像技术是可见的，用于传达所述进入端口的至少一个属性的信息指示。所述外罩体还提供施用抗微生物/抗血栓形成覆层的适合的表面。
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1D为根据一个实施方案的可植入的包覆模制的(overmolded)进入端口的各种视图；
图2A-图2D为图1A-图1D的进入端口在包覆模制部分移除时的各种视图；
图3A-图3E为根据一个实施方案的可植入的包覆模制的进入端口的各种视图；
图3F为根据一个实施方案的进入端口本体的底视图；
图4为与图3A-图3E的进入端口一起使用的端口凸缘的顶视图；
图5为根据一个实施方案的端口凸缘的顶视图；
图6A-图6C为根据一个实施方案的端口凸缘和相关部件的各种视图；
图7为根据一个实施方案的可植入的包覆模制的进入端口的透视图；
图8为根据一个实施方案的可植入的包覆模制的进入端口的透视图；
图9为根据一个实施方案的包括标识部分的可植入的进入端口的截面图；
图10为根据一个实施方案的包括锚定装置的可植入的进入端口的本体部分的透视图；
图11为根据一个实施方案的包括锚定装置的可植入的进入端口的本体部分的透视图；
图12为根据一个实施方案的包括锚定装置的可植入的进入端口的本体部分的透视图；
图13A-图13B为根据一个实施方案的包括顺从性本体部分的可植入的进入端口的各种视图；以及
图14A-图14B为根据一个实施方案的包括锚定装置的可植入的进入端口本体的各种视图。
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。
图1A-图14B描绘本发明的实施方案的各种特征，本发明的实施方案总地涉及用于提供对患者身体皮下进入的进入端口。具体地，在一种实施方式中，进入端口被植入患者体内，然后与已经被插入患者脉管系统的导管流体地连接。经这样的安置和配置，进入端口可以由针或其他输注/抽吸装置经皮地进入，从而经过端口和导管给药至患者脉管系统，或者从患者的脉管系统抽吸血液或其他流体。
此外，在本文要描述的实施方案中，进入端口包括顺从性外罩体，所述顺从性外罩体增加植入时的患者舒适度并且提供将端口缝合或以其他方式固定在患者体内的增强的选项。另外，在一个实施方案中，顺从性外罩体包括生物可兼容材料(例如有机硅)，该生物可兼容材料提供抗微生物和/或抗血栓形成覆层可以被施用于其上的适合的表面，以减少患者由植入进入端口带来的风险或感染。在一个实施方案中，进入端口的附加特征包括标识部分和锚定装置，该标识部分用于通过X-射线成像识别端口的属性，该锚定装置用于将外罩体固定到内部端口本体。
首先参照图1A-图2D，图1A-图2D根据一个实施方案示出一般地被标注为10的可植入的进入端口(“端口”)的各种视图。如所示出的，端口10包括限定底面14和流体腔20(图2A)的内部本体12。下面要进一步论述的外罩体16绕本体12被设置以基本上覆盖本体12，除了流体腔20的开口22以及被置于该开口中以覆盖该流体腔的可穿透间隔件24。
更具体地，在图示说明的实施方案中间隔件24通过固位环(retainingring)26在流体腔20的开口22中被保持在适当位置上，固位环26被插入开口22来以紧配合(interferencefit)接合端口本体12。如在图1C中最佳可见的，外罩体16覆盖端口10的本体12的表面达到(upto)绕固位环26的圆形区域。除了在附图中明确示出的内容，外罩体可以包括其他配置。
在本实施方案中，端口10的本体12包括钛或其他适合的金属材料。在本文要描述的其他实施方案中，端口本体包括非金属材料。端口10的附加细节包括多个触按件28和与流体腔20流体连通的流体出口30，所述多个触按件28被包括在间隔件28的顶面上，以在皮下放置之后辅助端口的识别。限定一管道(conduit)的导杆(stem)32被固定地接纳在流体出口30中，从而在流体腔20和附接到导杆的导管之间提供流体通道。
如所提到的，外罩体16包括顺从材料并且覆盖端口本体12。在一个实施方案中，外罩体16包括具有30的A型肖氏强度(30ShoreAdurometer)的有机硅、生物可兼容材料，然而要理解的是，还可以采用其他适合的生物可兼容和顺从材料(包括热塑弹性体)。由于其顺从性质，外罩体16在被植入患者体内时为其提供增加的舒适度。此外，外罩体16是由针可刺穿的以使得通过该外罩体上的大量位置的缝合都是牢固的，从而提供将端口固定到患者体内的便捷性。
另外，在一个实施方案中，顺从性外罩体16提供施用用于部件10的一个或更多个覆层的适合的表面。这在一些情况下确实是如此的，例如，在端口本体12包括钛或其他金属或者以DELRINTM的名义出售的乙酰基树脂(acetylresin)的情况下，覆层通常相对难于附着到这些材料。
在一个示例性实施方案中，抗微生物和/或抗血栓形成覆层(一个或多个)可以被施用到外罩体16的表面，以防止在端口10上或端口10周围生长细菌和/或形成血栓。可以被施用到端口10的外罩体16的覆层的非限制性实例可以参见以下内容：2005年8月1日递交的、题目为“抗微生物银组分(AntimicrobialSilverCompositions)”的美国专利申请公开No.2007/0003603；2007年2月8日递交的、题目为“用于金属纳米粒子处理的表面的方法和组分(MethodsandCompositionsforMetalNanopanicleTreatedSurfaces)”的美国申请公开No.2007/0207335；以及2007年4月25日递交的、题目为“抗微生物部位敷料(AntimicrobialSiteDressings)”的美国申请公开No.2007/0293800。进一步的覆层实例可以参见以下内容：题目为“形成抗微生物聚合物表面的方法(MethodofMakingAnti-MicrobialPolymericSurfaces)”的美国专利No.6,808,738，题目为“通过治疗型水凝胶的药物递送(DrugDeliveryviaTherapeuticHydrogels)”的美国专利No.6,475,516，以及2002年2月26日递交的、题目为“形成抗微生物聚合物表面的方法(MethodofMakingAnti-MicrobialPolymericSurfaces)”的美国专利申请No.2004/0086568。前述专利和申请中的每个通过引用并整体并入本文。还可以采用本领域技术人员能够意识到的其他覆层。
在一个实施方案中，施用到外罩体的抗微生物覆层包括银并且还包括防止外罩体明显变色的组分，例如通常被称为亮绿的CAS号633-03-4(BrilliantGreen，CASnumber633-03-4)的染剂组分。在又另一实施方案中，抗微生物、抗血栓形成或其他适合的材料可以被添加到外罩体材料，并且被配置来以期望的速率从外罩体材料洗提(elute)来为外罩体的表面提供期望的性质。在一个实施方案中，外罩体可以被着色来落入基于匹配系统(MatchingSystem)(新泽西州卡尔士达特市的Pantone公司)的具体颜色范围，例如Pantone3272M以及类似的颜色(Droximatecolors)。
注意的是，在图1A-图2D的本实施方案中所示的端口10的本体12和固位环26包括钛。在下面描述的某些实施方案中，其他材料被用于端口本体。应当记得的是，除了本文所公开的内容之外，其他适合的材料也可以被用于端口的各种组分而不脱离本文所描述的实施方案的精神。
根据一个实施方案，端口10还包括绕该端口的本体12的周缘径向地延伸的凸缘40。如在图1B中最佳可见的，凸缘40绕间隔件24和流体腔20的开口22并且邻近间隔件24和流体腔20的开口22被周向地安置。被这样地配置，凸缘40用作针挡护件(needleguard)，用于防止针或其他输注/抽吸装置穿入外罩体16相对靠近端口10的间隔件24的部分。这样又防止针的使用者穿透顺从性外罩体16以及由此相信该针己经进入间隔件24，间隔件24在一个实施方案中也包括顺从材料，例如有机硅。在这样的情况下，凸缘40将阻止使用者将针穿入外罩体，这将提示使用者需要将针再次插入以进入间隔件24，由此避免进一步的问题。要理解的是，在本实施方案中，凸缘与端口本体一体地形成并且由此包括钛。然而，在其他实施方案中，凸缘可以被分开制造，可以包括其他适合的材料，可以从端口本体的其他区域延伸而不是邻近间隔件的地方，并且可以包括不同的形状和配置。
在一个实施方案中，凸缘40还用来以包括特定特征或属性的方式使能端口的识别。例如，凸缘40可以包括通过X-射线或其他类似的成像技术可见的一个或更多个标识部分，从而在端口植入患者体内之后使能端口相应属性的识别。可以被标识部分指示的属性的一个实例是端口以相对高的流速(通常被称为动力注入)在其中进行流体输注的能力。这样的动力可注入性是有用的，例如，当通过与对患者身体进行的计算机断层(“CT”)成像过程结合使用的端口10注入对比剂时。在一个实施例中，通过端口的动力注入流以每秒约零至五毫升的速率进行，然而这可以根据若干因素而改变。
根据以上所述，在一个实施方案中，端口凸缘40包括在图1C、图1D以及图2D中最佳可见的一个或更多个标识部分50。具体地，本实施方案的标识部分50包括被限定在凸缘40的本体中的字母数字记号52。更详细地，本实施方案中的凸缘40包括一组三个字母数字记号52，其中每个记号包括被限定通过该凸缘厚度的字母“CT”，从而在端口通过X-射线被成像时在凸缘的CT孔和周围本体之间提供射线成像对比度。“CT”字母的定向是这样的，以至于其在X-射线下的观察将指示端口在患者体内是否被恰当地安置并定向。
考虑的是，上面描述的标识部分50可以为一个或更多个字母数字字符，例如图1A-图2D中描绘的“CT”。此外，本公开考虑在凸缘上使用其他标记，例如一个或更多个符号、图案、字符、设计及其组合等。标识部分(一个或多个)可以为任何尺寸、形状或者为任何的尺寸和形状这二者，以针对该进入端口的各种属性中的一个或更多个的特定识别定制该标识部分。具体地，在一个实施方案中，如已论述的，标识部分(一个或多个)可以向操作者传达关于所植入的端口的动力可注入性的信息。标识部分可以传达的属性的其他实例包括端口类型、导管类型、生产日期、材料批次、零件编号等。在其他实施方案中，标识部分可以以其他方式来限定。
在一个实施方案中，凸缘40还起到另一个作用，即用于固定端口本体12和外罩体16之间的接合的锚定装置。如上所述的，在本实施方案中，字母数字记号(“CT”)52被限定为通过凸缘40厚度的孔，该凸缘与端口10的内部本体12一起被包括。在端口10的制造期间，外罩体16通过包覆模制工艺裹包端口本体12，其中有机硅或其他适合的可流动的材料被注入包含端口本体12的模具，从而有机硅裹包该端口本体的大部分，包括凸缘40。然后，有机硅被允许固化以形成外罩体16。在包覆模制工艺期间，可流动的有机硅流过CT记号52的孔并且在固化完成之后保持于所述孔中，从而通过有机硅来限定CT孔中和通过CT孔的结合，由此将外罩体16作为单个部件锚定到端口本体12并且防止其间的分离。
如下面将进一步可见的，如本文所描述的锚定装置可以自图1A-图2D中所示的内容被修改。在一个实施方案中，粘合剂可以被用来将外罩体16粘合到端口本体12，特别是在外罩体邻近端口本体开口22的圆形端部附近。在该区域中粘合外罩体可以用来防止施用到该外罩体的外表面的任何覆层或层在外罩体16之下渗出。适合的粘合剂的实例是从加利福尼亚州卡平特里亚市的NuSil技术有限责任公司(NuSilTechnologyLLCofCarpinteria，CA)可获得的。
如在图1D中最佳可见的，在一个实施方案中，在包覆模制外罩体之前，包括与外罩体16相同材料的插入体56被附着到内部端口本体12的底面14。插入体56的目的在于，在该外罩体被包覆模制到该本体上之前，帮助将内部端口本体12稳定和固定在模具中。在一个实施方案中，外罩体16和插入体56二者都包括有机硅，从而在包覆模制工艺期间这二者整合在一起。在图3F中所示的另一实施方案中，包括适合的不透射线材料(例如钛)的盘70可以替代内部端口本体12的底面14上的插入体56并且可以包括通过X-射线成像设备的相互作用可见的标识部分50，从而该端口的特征或属性在植入之后是可以被识别的。在图示说明的实施方案中，盘包括字母“CT”的字母数字状切去部分(cutout)。
图3A-图3E描绘根据另一实施方案的端口10的各种视图，其中端口的内部本体12包括热塑塑料，例如通常以DELRINTM的名义出售的乙酰基树脂。如在图3B中最佳可见的，端口本体12包括基部12A和盖体12B，基部12A和盖体12B通过超声波焊接或其他适合的工艺被配接在一起以限定流体腔20并且将间隔件24锁定(capture)于其间。这样，没有像图1A-图2D的先前实施方案的金属端口那样采用固位环。
图3A-图3E的端口10包括作为被附接到端口10的本体12的分开制造的部件的凸缘40。具体地，并且还参照图4，本实施方案的凸缘40包括中心孔40A，以使得凸缘能够接纳端口本体12通过其中并且如图3B和图3C中最佳可见的，位于被限定在盖体12B上的凸台(ledge)顶部。多个凹口60绕凸缘40的中心孔40A的周缘被限定并且对应于被包括在盖体12B的凸台上的多个延伸的舌62。凹口60和对应的舌62相对于彼此是以键形结合的(keyed)，从而使凸缘40能够仅就位于凸台顶部的正确定向上，也就是说，确保字母数字记号相对于端口被安置在正确定向上。
在本实施方案中，在图3C所示的制造期间于凸缘40已经被恰当安置在盖体12B上之后，其凹口60将就位于盖体的舌62上。舌62然后可以通过熔化、机械或其他适合的变形工艺被变形，从而将凸缘40锁固在盖体12B上并且防止其从盖体12B移除。
如所提及的，图4示出凸缘40的其他细节，包括每个标识部分50的字母数字记号52、中心孔40A以及凹口60。注意的是，在本实施方案中，凸缘包括钛并且凸缘40的外周缘一般地限定凸出的(bulged)三角，其中在所述三角的每个顶部处安置有字母数字记号52中相应的一个，该记号起到标识部分和将外罩体16固定到端口本体12的锚定装置这两个作用。在一个实施方案中，“CT”记号52通过线EDM切割被形成在凸缘40中，然而也可以采用其他可接受的方法，包括冲压、模制等。要理解的是，凸缘的尺寸、形状和组分以及标识部分的结构可以不同于本文所示出并描述的内容。例如，凸缘可以包括的其他适合的材料可以参见2010年6月8日递交的、题目为“以射线成像方式识别进入端口的系统和方法(SystemsandMethodsforRadiographicallyIdentifyinganAccessPort)”的共同待审的美国专利申请No.12/796,133，该申请通过引用被整体并入本文。
图5-9示出关于凸缘40的附加实施方案的细节。图5示出根据一个实施方案的凸缘40，其中标识部分50(在此被表示为字母数字记号52)没有被限定通过凸缘的整个厚度，而仅被限定部分地穿过凸缘的厚度，从而形成凹陷的特征。在一个实施方案中，记号52被限定为在凸缘40中具有约0.015英寸的深度，该凸缘包括的总厚度约为0.020英寸，然而其他深度和凸缘厚度也是可能的。这使得“CT”记号52(在植入之前)仅在以自上至下的视角观看端口10时是在视觉上可视的，例如图1C和图3D中所示的视角。另外，以这种方式形成的CT记号52提供充分的射线成像对比，以使得记号能够在端口植入之后通过X-射线成像能够被成像，由此起到端口10所需的标识部分的作用。记号52可以通过线EDM加工、激光蚀刻等来形成。此外，多个通孔76被限定通过凸缘40的厚度，以用作凸缘的锚定装置。凸缘40以与图1A-图3E所示的类似的方式被安置。
注意的是，在上面的实施方案和要遵循的选定的实施方案中，用于识别端口属性的标识部分被这样配置，以至于它们(例如，在植入之前)仅从预先确定的视角是在视觉上可视的，例如图5中所示的自上至下的视角。在一个实施方案中，标识部分的这种限定视角的视觉观看是有用的，以指示临床医生端口的顶部；也就是说，当端口被顶部朝上地放置时，标识部分是在视觉上可以被识别的，指示恰当的定向，用于将端口插入患者的身体。然而，当端口是被倒置时，标识部分在视觉上是不可见的，由此指示临床医生该端口是被倒置的。该特征由此可以用来消除临床医生关于端口恰当定向的困惑。此外，要理解的是，在一个实施方案中，端口的外罩体的全部或部分可以被制成不透明的，从而消除临床医生将凸缘的CT记号切去部分误认为是缝合线将通过的缝合孔的可能。
图6A-图6C示出根据另一实施方案的凸缘40，其中的“CT”字母数字记号52的每个被用作标识部分50，该“CT”字母数字记号52被限定为通过凸缘厚度的如先前实施方案中的切去部分。限定对应于每个记号52的“CT”的隆起浮雕字母“CT”的顺从性不透明三角形插头80被插入每个记号的“CT”切去部分，从而由此被固位。经这样安置，插头使得“CT”记号52(在植入之前)仅在以自上至下的视角观看端口10时是在视觉上可视的，例如图1C和图3D中所示的视角。当从端口底部在视觉上观看时，插头阻止各自的记号52被观察到。相反，插头底部的形状(在本实施方案中是三角形的)是可见的。注意的是，插头的形状可以改变，插头顶面上的隆起浮雕也可以改变，以对应于插头将被插入的记号的切去部分设计。
图7示出根据一个实施方案的端口10，其中端口的外罩体16包括毛化表面(frostedsurface)84或者以其他方式模糊化的(obscured)表面，从而使得该外罩体是不透明的。在一个实施方案中，端口10的毛化表面16在包覆模制阶段期间实现，其中用于将外罩体16包覆模制到内部端口本体12的模具的表面包括例如通过模具表面的喷丸处理(beadblasting)获得的粗糙表面。当外罩体16以这样的模具被包覆模制时，得到图7的毛化表面84。要理解的是，还可以采用其他适合的方法为外罩体16提供毛化表面或不透明的表面。在又另一实施方案中，仅有外罩体的底面是毛化的。
在另一实施方案中，织物或网状结构可以被并入/嵌入端口的外罩体，从而使其是不透明的。在又另一实施方案中，不是喷丸处理，磨具表面可以被处理来在其上限定钻石形网状表面特征，这将在端口外罩体模制于其中时赋予该端口外罩体粗糙的不透明表面。在又另一实施方案中，徽标(logo)或其他特征可以被刻入该端口外罩体，或者作为该外罩体在其中被包覆模制到端口本体的模具表面的表面特征被包括，从而使得该外罩体至少部分地为不透明的。因此，可以设想用于使外罩体不透明性的这些和其他处理。
图8示出根据一个实施方案的端口10，其中着色剂或其他适合的不透明添加剂与用于形成外罩体16的材料(例如，有机硅)一起被包括，从而使得外罩体是不透明的。在一个实施方案中，诸如由加利福尼亚州安大略的Kreative流体颜料公司(KreativeLiquidColorofOntario，CA)提供的Kreative紫色K-6050-13(KreativeColorPurple，K-6050-13)着色剂在包覆模制工艺之前与有机硅混合，在包覆模制完成之后得到端口10的不透明的外罩体16。当然，还可以采用其他材料和方法来使得外罩体为不透明的。在一个实施方案中，着色剂或不透明的添加剂的所需特征包括射线半透明、生物兼容性以及与形成外罩体的材料的兼容性。
图9示出根据另一实施方案的端口10，其中除了凸缘40之外，如图9所示的，第二板90被安置在凸缘之下。与凸缘40一样的，板90被外罩体16覆盖并且在一个实施方案中包括通孔来用作确保外罩体16和端口10的内部本体12之间的接合的锚定装置。同样是与凸缘40一样的，板90可以包括钛、三氧化二铋或其他适合的材料，或者可以在组分上不同于凸缘40。如图9所示地，板90的安置将用作凸缘40的标识部分的记号的视觉观察限定为如图1C和图3D中的自上至下的观看。
图10-图12描绘各种实施方案，公开用于端口10的内部本体12的锚定装置的附加实施例。要描述的锚定装置在将包覆模制的外罩体固定到内部端口本体时，以与上面的实施方案中所描述的凸缘40的“CT”记号切去部分和其他锚定装置类似的方式操作。
在图10中，锚定装置130被包括在端口本体12的凸缘140上。凸缘140绕包括在端口本体12上的间隔件24并且邻近间隔件24被周向地安置。具体地，锚定装置被实施为被限定通过凸缘140的多个通孔142。此外，在凸缘140下一充分距离处，一个或更多个凸伸部146从端口本体12延伸来限定附加的通孔148。如已经结合本文的包括锚定装置的该实施方案和其他实施方案所描述的，用于形成外罩体的有机硅或其他适合的材料在包覆模制工艺期间绕端口的内部本体12流动，通过锚定装置130来合乎期望地加强外罩体到端口本体的附着。
图11示出端口本体12的锚定装置130的另一实施例，其中在邻近端口本体12的底部14处限定环形槽150。多个通孔152被限定在该槽中从而自该槽延伸至端口本体底面14，以使得在包覆模制工艺期间外罩体材料能够流过其中。
图12描绘锚定装置130的又另一实施例，其中多个齿160从端口本体12的表面延伸。具体地，在图12中，相对的齿对(pairsofteeth)160被示出朝向彼此延伸，不仅在相对的齿之间提供空隙，并且还在齿和端口本体12的相邻侧面之间提供空隙，从而提供外罩体材料在包覆模制以将外罩体锚定到端口本体之后凝固之前可以流过的适合的空间。齿的尺寸、形状、数目以及位置可以以多种方式改变。更一般地，要理解的是，前面的实施方案仅是锚定装置的实施例，在本发明的实施方案的原理中可以存在锚定装置的其他类型和结构。
图13A和图13B描绘根据一个实施方案的端口210，其中端口的本体212包括第一本体部分212A和第二本体部分212B，该第一本体部分212A限定本体的鼻部，该第二本体部分212B限定本体的剩余部分。在本实施方案中，第一本体部分212A包括相对刚性的生物可兼容材料，例如乙酰基树脂或其他热塑塑料，而第二本体部分212B包括顺从包覆模制材料，例如有机硅或其他适合的生物可兼容材料。这样配置的，由第一本体部分212A限定的端口本体鼻部是相对刚性的，从而有助于端口放入患者的组织所限定的袋状区(pocket)，而由第二本体部分212B限定的端口本体212的剩余部分是顺从性的，以增加患者的舒适度并且提高端口210的可缝合性。第二本体部分的包覆模制可以以与先前的实施方案类似的方式实现。
图14A和图14B描绘锚定装置130的又另一实施例，其中多个楔形榫(dovetail)凸伸部220从端口本体盖体12B的圆形侧面绕其周缘延伸。楔形榫凸伸部220在相邻的楔形榫之间提供外罩体材料在包覆模制以将外罩体锚定到端口本体之后凝固之前可以流过的足够的表面面积和滞留(entrapment)区域。楔形榫齿的尺寸、形状、数目、位置以及间隔可以以多种方式改变。例如，除了被包括在端口盖体上之外，这些楔形榫凸伸部可以被包括在端口基部上。同时，尽管示出了绕端口盖体周缘的整体延伸，在一个实施方案中，楔形榫凸伸部可以被限定为仅部分地绕该处延伸。考虑这些和其他变化形式。
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 (26)

1.一种用于提供对患者皮下进入的进入端口，所述进入端口包括：
本体，所述本体限定经过间隔件可进入的流体腔，所述本体由第一材料形成；
顺从性外罩体，所述顺从性外罩体绕所述本体的至少一部分设置；以及
凸缘，所述凸缘由不同于所述第一材料的第二材料形成，所述凸缘和本体是独立的结构，所述凸缘第二材料与所述外罩体接触并且由所述外罩体覆盖并且从所述本体延伸，当针被用来穿入所述间隔件时，所述凸缘阻止所述针穿过所述外罩体内的所述凸缘。
2.如权利要求1所述的进入端口，其中所述凸缘绕所述本体的周缘径向地延伸，并且其中所述凸缘还包括用于将所述外罩体固定到所述本体的锚定装置。
3.如权利要求2所述的进入端口，其中所述本体包括盖体和基部，并且所述外罩体裹包所述盖体、所述基部和所述凸缘，所述锚定装置包括被限定通过所述凸缘的多个开口，所述外罩体的材料通过所述多个开口。
4.如权利要求3所述的进入端口，其中所述外罩体包括有机硅，其中所述凸缘包括钛，并且其中所述开口限定字母数字字符。
5.如权利要求1所述的进入端口，其中所述本体包括由所述外罩体覆盖、用于将所述外罩体固定到所述本体的锚定装置，所述锚定装置包括从所述本体延伸的多个齿和多个楔形榫凸伸部中的一个。
6.如权利要求1所述的进入端口，其中所述外罩体包括抗微生物组分和抗血栓形成组分中的至少一个。
7.一种用于提供对患者皮下进入的进入端口，所述进入端口包括：
本体，所述本体限定经过间隔件可进入的流体腔；
顺从性外罩体，所述顺从性外罩体绕所述本体的至少一部分设置；以及
凸缘，所述凸缘与所述本体独立，所述凸缘由所述外罩体覆盖并且被附接到邻近所述间隔件的所述本体，所述凸缘包括通过X-射线成像技术可见的标识部分，所述标识部分传达所述进入端口的至少一个属性的信息指示。
8.如权利要求7所述的进入端口，其中所述凸缘绕所述本体的周缘延伸，其中所述标识部分包括多个字母数字或标志性字符，并且其中所述标识部分指示所述进入端口是能够进行动力注入的。
9.如权利要求7所述的进入端口，其中所述标识部分包括被限定通过所述凸缘的至少一个孔，从而用作将所述外罩体固定到所述本体的锚定装置。
10.如权利要求7所述的进入端口，其中所述凸缘包括多个键形凹口，每个所述键形凹口装配到所述本体上的相应键形舌上，并且其中所述舌在所述凸缘凹口被置于所述舌上之后能够被这样变形，以至于所述凸缘由所述本体固位。
11.如权利要求7所述的进入端口，其中所述进入端口的所述本体包括乙酰基树脂，其中所述凸缘包括钛，并且其中所述凸缘阻止针插入所述外罩体一实质性距离。
12.一种用于提供对患者皮下进入的进入端口，所述进入端口包括：
本体，所述本体包括盖体和基部，所述本体限定经过间隔件可进入的流体腔；
顺从性外罩体，所述顺从性外罩体基本上覆盖所述本体以限定所述进入端口的外表面；以及
凸缘，所述凸缘与所述本体分开并且被附接到所述盖体，所述凸缘包括通过X-射线成像技术可见的标识部分，所述标识部分传达所述进入端口的至少一个属性的信息指示。
13.如权利要求12所述的进入端口，其中所述凸缘还包括将所述外罩体固定到所述本体的锚定装置。
14.如权利要求12所述的进入端口，其中所述标识部分也用作将所述外罩体固定到所述本体的锚定装置，并且其中所述凸缘被安置来阻止针插入所述外罩体一实质性距离。
15.如权利要求14所述的进入端口，其中所述凸缘一般地限定一三角形，并且其中所述标识部分包括设置在所述凸缘的每个顶部的字母数字记号。
16.如权利要求15所述的进入端口，其中所述字母数字记号被限定为所述凸缘中的凹陷特征，并且其中所述凸缘还包括被限定通过所述凸缘的多个通孔。
17.如权利要求12所述的进入端口，其中所述标识部分包括被限定通过所述凸缘的记号，并且其中顺从性插头被设置在所述记号中，从而防止所述记号从至少一个方向的可视观察。
18.如权利要求12所述的进入端口，其中由所述外罩体限定的所述外表面提供用于施用覆层于其上的适合的表面，以防止微生物粘附和血栓形成中的至少一个。
19.一种用于提供对患者皮下进入的进入端口，所述进入端口包括：
本体，所述本体限定经过间隔件可进入的流体腔；
顺从性外罩体，所述顺从性外罩体绕所述本体的至少一部分设置；以及
凸缘，所述凸缘与所述本体分开并且被附接到邻近所述间隔件的所述本体，所述凸缘由所述外罩体覆盖，所述凸缘包括通过X-射线成像技术可见的标识部分，所述标识部分传达所述进入端口的至少一个属性的信息指示，
其中所述外罩体的至少一部分被这样配置，以至于防止所述标识部分从至少一个方向的可视观察。
20.如权利要求19所述的进入端口，其中所述外罩体包括有机硅，并且其中所述外罩体的表面的至少一部分是毛化的，从而使所述表面的所述部分基本上为不透明的。
21.如权利要求19所述的进入端口，其中所述外罩体包括混合有着色剂的有机硅，从而使所述有机硅为不透明的。
22.一种制造用于提供对患者皮下进入的进入端口的方法，所述方法包括：
形成限定经过间隔件可进入的流体腔的本体；
形成包括锚定装置的凸缘；
将所述凸缘附接到邻近所述间隔件的所述本体；以及
以顺从性外罩体至少这样覆盖所述凸缘以至于所述外罩体裹包被包括在所述凸缘上的所述锚定装置，以将所述外罩体锚定到所述本体。
23.如权利要求22所述的制造进入端口的方法，还包括：将覆层施用到所述外罩体，所述覆层包括抗微生物和抗血栓形成组分中的至少一个。
24.如权利要求22所述的制造进入端口的方法，其中至少覆盖所述凸缘的步骤还包括绕所述端口的所述本体的大部分包覆模制所述外罩体，所述外罩体包括有机硅。
25.如权利要求24所述的制造进入端口的方法，其中包覆模制所述外罩体的步骤还包括绕所述端口的所述本体的大部分包覆模制所述外罩体，所述外罩体的表面的至少一部分包括毛化的表面以防止通过所述表面的可视观察。
26.一种用于提供对患者皮下进入的进入端口，所述进入端口包括：
本体，所述本体包括基部和可附接的盖体，所述基部和所述可附接的盖体配合限定经过间隔件可进入的流体腔；以及
凸缘，所述凸缘由不透射线的材料形成，所述凸缘被附接到邻近所述间隔件的所述盖体来阻止针在远端所述凸缘上的穿入，所述本体和所述凸缘不透射线的材料与顺从性外罩体接触并且基本上由顺从性外罩体覆盖。
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