CN102271737A - 用于识别进入端口的***和方法 - Google Patents
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Abstract
公开了一种用于皮下植入的进入端口。这样的进入端口可以包括用于锁定间隔件的本体,所述间隔件用于重复地使针穿过所述间隔件***被限定在所述本体中的腔。另外,所述进入端口可以包括至少一个特征,所述至少一个特征被构造并配置来在皮下植入后对所述进入端口进行识别。还公开了一种识别皮下植入的进入端口的方法。例如,皮下植入的进入端口可以被提供并且所述皮下植入的进入端口的至少一个特征可以被感知。此外,皮下植入的进入端口可以响应于感知所述至少一个特征而被识别。在一个实施方案中,标识特征可以被雕刻或者由所述进入端口以其他方式限定,从而在植入后通过X-射线成像技术是可视的。
Description
相关申请:本申请是2009年4月7日递交的题目为“进入端口识别***和方法(AccessPort Identification Systems and Methods)”的美国专利申请No.12/420,028的部分继续申请,该美国专利申请No.12/420,028是2006年3月6日递交的题目为“进入端口识别***和方法(Access Port Identification Systems and Methods)”的美国专利申请No.11/368,954的部分继续申请,该美国专利申请No.11/368,954要求2005年3月4日递交的题目为“进入端口识别***(Access Port Identification System)”的美国专利申请No.60/658,518的优先权。本申请还要求2008年10月31日递交的题目为“用于可植入端口的不透射线的且射线照相可辨识的指示符(Radiopaque and Radiographically Discernible Indicators for anImplantable Port)”的美国专利申请No.61/110,507的优先权。前面所引用的申请中的每个都通过引用被完整并入本文。
附图说明
图1A根据本公开示出进入端口的实施方案的立体视图;
图1B示出图1中所示的进入端口的示意性侧面剖视图;
图2根据本公开示出进入端口的实施方案的立体视图;
图3根据本公开示出进入端口的立体视图;
图4根据本公开示出进入端口的立体视图;
图5根据本公开示出进入端口的立体视图;
图6A根据本公开示出进入端口的立体视图;
图6B示出图6A中所示的进入端口的侧视图;
图7根据本公开示出进入端口的立体视图;
图8根据本公开示出用于形成进入端口的盖体的简化立体视图;
图9根据本公开示出用于形成进入端口的盖体的简化立体视图;
图10根据本公开示出用于形成进入端口的盖体的简化立体视图;
图11根据本公开示出用于形成进入端口的盖体的简化立体视图;
图12根据本公开示出用于形成进入端口的盖体的简化立体视图;
图13根据本公开示出用于形成进入端口的盖体的简化立体视图;
图14根据本公开示出用于形成进入端口的盖体的简化立体视图;
图15A根据本公开示出进入端口的实施方案的立体视图;
图15B示出图15A中所示的进入端口的顶部正视图;
图16根据本公开示出进入端口的立体视图;
图17根据本公开示出进入端口的立体视图;
图18根据本公开示出进入端口的立体视图;
图19根据本公开示出进入端口的立体视图;
图20根据本公开示出进入端口的立体视图;
图21根据本公开示出进入端口的立体视图;
图22根据本公开示出进入端口的另一实施方案的立体视图;
图23示出图22中所示的组装的进入端口的顶部正视图;
图24示出图22和23中所示的进入端口的横截面的简化表征;
图25-51示出进入端口的附加实施方案的立体视图;
图52根据一个实施方案示出进入端口的底部立体视图;
图53A示出图52中所示的进入端口的顶部视图;
图53B示出图52中所示的进入端口的底部视图;
图54A表征当从进入端口的上方观看时图52中所示的该进入端口的射线照相图像;
图54B表征当以约20度的角观看时图52中所示的进入端口的射线照相图像;
图54C表征当以约50度的角观看时图52中所示的进入端口的射线照相图像;
图55示出图52中所示的进入端口的剖视图;
图56A和56B示出进入端口表面上的雕刻特征(engraved feature)的示例性实施方案的剖视图;
图57A根据一个实施方案示出进入端口的顶部立体视图;
图57B示出图57A中所示的进入端口的底部立体视图;
图57C示出图57A中所示的进入端口的底部视图;
图58A示出进入端口的另一实施方案的顶部立体视图;
图58B示出图58A中所示的进入端口的底部立体视图;
图58C示出图58A中所示的进入端口的底部视图;
图59A示出进入端口的实施方案的侧视图;
图59B示出图59A中所示的进入端口的底部视图;
图60A示出进入端口的附加实施方案的底部立体视图;
图60B示出图60A中所示的进入端口的底部视图;
图61A示出进入端口的附加实施方案的底部立体视图;
图61B示出图61A中所示的进入端口的底部视图;
图62A示出进入端口的附加实施方案的底部视图;
图62B示出图62A中所示的进入端口的侧视图;
图62C示出图62A中所示的进入端口的端视图;
图63A示出进入端口的另一实施方案的底部视图;
图63B示出图63A中所示的进入端口的侧视图;
图63C示出图63A中所示的进入端口的端视图;
图64根据一个实施方案示出进入端口的顶部视图;
图65根据一个实施方案示出进入端口的立体视图;
图66A-66D根据一个实施方案示出进入端口的各种视图;
图67根据一个实施方案示出进入端口的底部立体视图;
图68A-68C根据一个实施方案示出进入端口的间隔件(septum)的各种视图;
图69根据一个实施方案示出进入端口的立体视图;
图70根据一个实施方案示出用于进入端口的标识(identifier)的立体视图;
图71根据一个实施方案示出用于进入端口的标识的顶部视图;
图72根据一个实施方案示出端口和包括标识的导管的立体视图;
图73A和73B根据一个实施方案示出用于进入端口的标识的各种视图;
图74A和74B根据一个实施方案示出用于进入端口的标识的视图;以及
图75A-75C根据一个实施方案示出用于进入端口的标识的各种视图。
具体实施方式
本公开总地涉及经皮进入,并且更具体地,涉及与经皮进入相关联的方法和装置。本公开一般地涉及用于皮下植入的进入端口。在一个实施方案中,进入端口可以允许医师或者其他医护人员获得对患者的身体内部的长期经皮进入。采用进入端口进行经皮进入可以通过抑制来自患者的皮肤和外部环境的流体连接(该流体连接延伸进入患者的身体内部)来降低感染的几率。进入装置允许进入患者的体内而无需用针刺穿皮肤。此外,内部部件(例如导管或瓣膜(valve))可以在不进行外科手术的情况下被替换。本公开的特征和各方面可以应用于任何这样的用来进行针对患者的皮下进入的进入端口,而不受限制。进入端口例如可以通过手工(例如,通过包括针的注射器)来被注入,或者可以通过机械辅助来被注入和压入(例如,被称为动力可注入端口)。
动力可注入端口可以被用于其他过程,例如,计算机断层(“CT”)扫描过程。更具体地,被称为“动力注入器”的***可以被用来将对比剂注入到末梢***静脉(IV)管。例如,这样的动力注入器或注入***在商业上可以从德国先灵公司(Schering AG)的子公司Medrad公司获得,并且可能是以STELLANT商标营销的。因为流体输注过程通常是根据对比剂的期望流率来限定的,这样的动力注入***在整体上通过选择期望的流率是可控制的。
更具体地,本公开涉及进入端口,该进入端口具有至少一个用于识别该进入端口的可感知的或可识别的特征,其中可识别的特征在该进入端口于患者体内被植入之后是可感知的。例如,由本公开所考虑的进入端口的至少一个或者可能多个可识别的特征可以与关于该进入端口的信息(例如,制造商的型号或设计)相关。因此,来自特定型号的进入端口的可识别的特征与不同型号或设计的另一进入端口的大部分(即便不是所有的)其他可识别的特征相比可以是唯一的。当然,由本公开所考虑的进入端口的至少一个可识别的特征还可以与任何感兴趣的信息相关,例如端口的类型、导管类型、生产日期、材料批次、零件编号等。在一个实施例中,进入端口的至少一个可识别的特征可以与动力可注入的进入端口相关。以这种方式,一旦进入端口的至少一个可识别的特征被观察到或以其他方式被确定,进入端口的这样的至少一个特征的相关性可以被实现,并且关于该进入端口的信息可以被获得。
在一个实施方案中,至少一个特征可以通过触按(即,通过触摸进行检查)、以其他身体上的相互作用方式或者通过视觉观察被感知。因此,感兴趣的人可以通过皮肤触摸或触碰该进入端口以感知其至少一个识别特性。在另一实施方案中,至少一个可识别的特征可以通过X-射线或超声波成像被感知。在又另一实施方案中,至少一个可识别的特征可以通过磁性物质、光或无线电能量作用或者与该进入端口的通信被感知。
转向实施方案,其中至少一个特征可以通过触按、其他身体上的相互作用或者视觉观察被感知,由本公开所考虑的进入端口的形貌(topography)或外表面特征可以被配置来用于感知。例如,参照图1A和1B,由本公开所考虑的示例性进入端口10被示出。图1A和1B分别示出用于允许对患者的身体的经皮或者以其他方式内部进入的进入端口10的立体视图和示意性侧面剖视图。进入端口10包括由盖体14和基部16限定的壳体或本体20。如本领域已知的,盖体14和基部16可以被配置来将间隔件18锁定(capture)于其中。如在图1A中所示的,盖体14和基部16可以以配接的方式沿配接线15相互接合。盖体14和基部16可以通过机械紧固件(例如螺丝或其他紧固器件)被固定或相互附着(affix),可以以粘合的方式被相互附着,或者可以如本领域已知的被相互附着。另外,盖体14、基部16以及间隔件18可以共同限定与出口导杆(outlet stem)31的内腔29流体连通的腔36。
如图1B所示,本体20可以被植入患者7,来以皮下的方式将腔36设置在患者7体内。再者,如果期望的话,缝合孔66(图1A)可以被用来在患者7体内附着进入端口10。在本体20被植入患者7后,间隔件18的上表面可以与患者7的皮肤6表面基本上齐平,并且可以被重复地穿刺以创建从患者的皮肤外部到腔36内的经皮通道。出口导杆31可以创建从腔36通过出口导杆31并且进入患者7体内的流体连通的通道。导管可以被耦合到出口导杆31以与腔36流体连通并且将流体从腔36转移至远离腔36而在患者7体内的期望的远端位置。
进入端口10的本体20可以包括生物兼容的材料,例如聚砜、钛,或者本领域已知的任何其他适合的生物兼容的材料。因此,本体20可以由生物兼容的塑料材料形成。如果期望的话,本体20可以包括可刺穿的材料,用于由缝合线或针进行的穿透。在另一实施方案中,并且如下面将进一步论述的,如果期望的话,本体20可以包括不可刺穿的材料,例如金属。本体20可以包括凹形底部,或者在另一实施方案中,可以包括平坦的底部,而不受限制。
根据本公开,进入端口10可以包括呈现至少一个可识别的特征的本体20。更具体地,如在图1A中所示的,本体20可以大体上呈现部分金字塔的形状(即,由于多边形的每一侧均朝向共同的顶点延伸而具有多个表面的多边形的基部,或者被称作截头锥体)。一般地,进入端口10的本体20可以呈现为在被设置于参考平面11的大体上为四边形的基面和被设置于参考平面9的大体上为四边形的上基面之间延伸的部分金字塔的形状。为清楚起见,参考平面9和11在图2-21中将不再示出;然而,如在本文中所使用的,结合图2-21对平面9或11的参照将涉及与如图1A和1B中所示的参考平面9和11类似的相应参考平面。
如在图1A中所示的,进入端口10的外部基本上由通过弧形边(radius)32相互连接的四个基本上为平面的侧表面50限定。此外,进入端口10的上部形貌61由上表面60与凹槽46A和46B结合限定,并且可以由间隔件18的上表面进一步限定。进一步来说,上部形貌61的外边缘可以被描述为由侧区域54形成的大体上为四边形的外部并且具有邻接侧区域54的圆角区域30。这样的配置可以提供具有可以通过触按被感知的至少一个特征的进入端口。
可以理解的是,如图1A所示的进入端口10的几何结构可以存在许多变体。例如,进入端口10的本体20可以被描述为部分金字塔的形状或者截头锥体,然而本公开并不局限于此。相反,侧表面50中的一个或更多个可以根据可能的期望被定向,而无需顾及任何其他的侧表面50。因此,例如,表面50中的一个可以基本上为垂直的,而剩下的表面50可以分别以选定的角被定向。另外,应当理解的是,图1A仅仅是示例性的并且如图1A中所示的尺寸和形状在本质上可以改变,而仍然被本公开所包含。
图2根据本公开示出进入端口10的另一实施方案的立体视图。如图2所示,进入端口10的外部基本上由大体上为平行四边形的基面(被设置于如图1A和1B所示的参考平面11)限定,该基面到大体上为平行四边形的上表面(被设置于如图1A和1B所示的参考平面9)大体上以成金字塔形的方式延伸。如图2所示,弧形边42可以大于图1A中所示的弧形边32。另外,如图2所示的进入端口10的上部形貌61可以包括圆角区域40,圆角区域40大于如图1A所示的圆角区域30。因此,图2示出进入端口10的示例性实施方案,该进入端口10可以是以可感知的方式与如图1A和1B所示的进入端口10区分开的。例如,由本公开所考虑的进入端口的一种外部和由本公开所考虑的不同的进入端口的另一种外部之间的区别可以以触按的方式来确定。
在另一实施方案中,在由本公开所考虑的另一方面,模板可以被用来感知进入端口的至少一个特征。例如,以互补方式成形的模板可以被设置在由本公开所考虑的进入端口上并且紧靠该进入端口,以确定该进入端口是否匹配或基本上对应于该模板的形状。这样的过程可以以可靠的方式指示或感知由本公开所考虑的进入端口的至少一个特征。当然,对应于进入端口的不同型号的多个模板可以成序列地与未知的进入端口接合,以感知其至少一个特征。这样的过程可以允许由本公开所考虑的进入端口的识别(例如型号或制造商的识别)。
在由本公开所考虑的另一个方面,进入端口的上部形貌可以包括用于识别该进入端口的至少一个特征。例如,如图3所示,进入端口10的上表面60可以为非平面的。更具体地,上表面60由于其朝向间隔件18成放射状地向内延伸而可以成锥形或者可以以成弓形的方式向下(即,朝向如图1A和1B所示的参考平面11)延伸。或者,如图3所示,进入端口10可以基本上如上面参照图1A和1B所描述的被配置。因此,上表面60是用于识别由本公开所考虑的进入端口的至少一个可感知的特征的一种示例性实施例。
在由本公开所考虑的进入端口的又另一实施方案中,在圆角区域30之间延伸的侧区域54可以呈现至少一个可感知的特征。例如,如图4所示,进入端口10可以包括在邻接的圆角区域30之间以成弓形的方式延伸的一个或更多个侧区域54。或者,如图4所示,进入端口10可以基本上如上面参照图1A和1B所描述的被配置。侧区域54可以相对于彼此是全等的或对称的,或者在另一实施方案中,可以相对于彼此以不同的方式被配置,而不受限制。
图5示出由本公开考虑的进入端口的又一示例性实施方案。更具体地,如图5所示,进入端口10包括在邻接的圆角区域30之间形成凹陷区域72的侧区域54。换言之,上部形貌61可以包括大体上绕间隔件18的边缘设置的交替的凹陷区域72和突起区域70。或者,如图5所示,进入端口10可以基本上如上面参照图1A和1B所描述的被配置。这样的配置可以提供具有至少一个可识别的特征的进入端口。
在由随后的公开内容所考虑的进入端口的又一实施方案中,图6A和6B分别示出进入端口10的立体视图和侧视图,该进入端口10大体上如参照图5所描述的被配置,但是具有拉长的本体20E。更具体地,如图6A和6B所示的进入端口10的拉长的本体20E包括侧表面50E,侧表面50E大体上从上部形貌61向下(即,朝向如图1A和1B中所示的参考平面11)延伸并且具有不同于另一种侧表面50的倾斜(例如,相对于沿间隔件18的上表面的法线方向的垂直轴的角)。或者,如图6所示,进入端口10可以基本上如上面参照图1A和1B所描述的被配置。这样的配置可以提供具有拉长的侧部分的进入端口10的拉长的本体20E。
当然,根据本公开的进入端口的一个或更多个侧表面可以被配置用于根据可能的期望形成呈现选定的形状的本体。由本公开所考虑的进入端口的拉长的本体部分可以如上所述地结合其他特征形成,或者在另一实施方案中,单独形成用于识别根据本公开的进入端口的至少一个可感知的特征。
图7示出由本公开所包含的进入端口的又一实施方案。具体地,如图7所示,进入端口10可以包括上本体部分20a和下本体部分20b。另外,上本体部分20a和下本体部分20b中的每个可以呈现部分金字塔的形状(即,截头锥体),其中本体部分20a和20b相对于彼此被垂直地堆叠。因此,上本体部分20a可以形成沿进入端口10的边缘延伸的悬伸缘构件76。进一步来说,下本体部分20b可以具有基本上由侧表面50b限定的外部以及圆角区域30b,而上本体部分20a可以具有基本上由侧表面50a限定的外部、圆角区域30a以及上部形貌61。可以理解的是,悬伸缘构件76可以被选择尺寸并配置用来通过触按获得感受。这样的配置可以提供适合的进入端口用于有益物质或医疗物质的传递,该进入端口在被植入后是可识别的(例如,通过型号数字、制造商等)。
应当理解的是,本公开考虑具有在本质上不是平行四边形的外部几何结构的进入端口。更确切地说,本公开考虑的是,进入端口可以具有大体上为圆柱状、大体上为圆锥状、大体上为椭圆状、大体上为卵状的外部,或者具有在本质上为其他弓形的外部。具体地,本公开考虑的是,具有基本上为圆形或弓形外部的进入端口可以包括被配置用于在植入之后识别该进入端口的至少一个特征。例如,如图8所示,示出呈现外部表面78的盖体14,该外部表面78基本上是圆锥状的。盖体14可以被组装到适合的基部(未示出)以如上所述的锁定间隔件(未示出),来大体上如结合图1-7所述的形成进入端口10。
本公开进一步考虑的是,不同高度的至少一个突起、突起区域、凹陷、凹陷区域、波状部分(undulation)或邻接的构件可以包括用于识别由本公开所考虑的进入端口的特征。更具体地,如图8所示,上部形貌61C可以包括多个突起80。突起80可以部分地呈现过渡到盖体14的下部分的球状上表面。更加详细地,突起80可以根据可能的期望绕间隔件(未示出)的边缘被周向地间隔。在一个实施方案中,多个突起80可以绕间隔件(未示出)的边缘以对称的方式被周向地间隔。更一般地,至少一个突起80可以被选择尺寸、配置并且定位来形成进入端口的至少一个可识别的特征。当然,至少一个突起80可以被构造用于便利使该进入端口被植入其体内的患者舒适。如可以理解的,至少一个突起80或者多于一个突起80可以被包括在由本公开所考虑的进入端口(未示出)的上部形貌61C中。
图9示出盖体14的另一实施方案,该盖体14包括至少一个突起80E,用于在由本公开所考虑的进入端口植入患者体内之后形成并识别该进入端口。突起80E可以绕公转中心周向地延伸。因此,突起80E可以呈现在圆形端部83之间周向地延伸的本体87部分。另外,盖体14可以具有绕公转轴基本上为对称的外表面78。更一般地,本体20可以从被设置于盖体14的下延伸部71的大体上为圆形、大体上为椭圆状或者大体上为卵状的基部延伸至大体上为圆形、大体上为椭圆状或者大体上为卵状的上截面,该上截面小于该基部的截面并且被设置于盖体14的上延伸部73(没有考虑突起80E)。此外,如图9所示,侧表面51在该基部和盖体14的上部形貌61之间以成弓形的方式延伸。侧表面51可以大体上以成锥形或圆锥状的方式延伸,可以呈现弧形边或其他弓形,或者可以在该进入端口的该基部的截面和邻近其上部形貌61C的截面之间以其他方式过渡。
此外,图10示出盖体14的实施方案,该盖体14用于形成由本公开所考虑的进入端口,该进入端口使其上部形貌61C包括交替的周向延伸突起80E以及周向延伸凹陷82,其中周向延伸突起80E在圆周方向上大于周向延伸凹陷80E。在由本公开所考虑的进入端口的另一实施方案中,图11示出盖体14的立体视图,该盖体14使其上部形貌61C包括交替的周向延伸突起80E以及周向延伸凹陷82,其中周向延伸突起80E和周向延伸凹陷82在(周向的)尺寸或延伸情况上是基本上相等的。在用于形成由本公开所考虑的进入端口的盖体14的又另一实施方案中,图12示出盖体14的立体视图,该盖体14使其上部形貌61包括被这样设置的三个周向延伸突起80E和三个周向延伸凹陷82,以圆周方向上交替,其中周向延伸突起80E和周向延伸凹陷82在(周向的)尺寸上基本上是相等的。
图13示出用于形成由本公开所考虑的进入端口的盖体14的附加实施方案的立体视图,该盖体14包括上部形貌61C,该上部形貌61C包括周向延伸突起80T和周向延伸凹陷82T,其中过渡区域81被提供在周向延伸突起80T和周向延伸凹陷82T之间。如图13所示,这样的过渡区域81在周向延伸突起80T和周向延伸凹陷82T之间可以是渐变过渡或大体上为平滑的过渡。同样,图14示出用于形成由本公开所考虑的进入端口的盖体14的附加实施方案的立体视图,该盖体14包括上部形貌61C,该上部形貌61C包括相互之间过渡且交替周向的突起区域96和凹陷区域98,以形成包括上部形貌61C的波状形貌。如图14所示,这样的波状形貌在圆周方向上邻接的突起区域96和凹陷区域98之间大体上是平滑过渡的。
在由本公开所考虑的进入端口的又一实施方案中,图15A和15B分别示出进入端口10的立体视图和顶部正视图,该进入端口10大体上如参照图5所描述的被配置,只是还可以包括至少一个非平面的侧表面。在另一个实施方案中,如图15所示的进入端口10可以如图1-4或图6-7所示的被配置,或者如上所述的任何实施方案被配置,而不受限制。更具体地,如图15A和15B所示,进入端口10的拉长的本体20包括三个以成弓形的方式延伸的(如图15B所示)侧表面50R。这样的配置可以提供在植入之后是可识别的进入端口10。在由本公开所考虑的进入端口的又另一实施方案中,图16示出包括侧壁100的进入端口10的立体视图,该侧壁100截断形成于进入端口10的侧表面50之间的弧形边32的部分。还要注意的是,这样的进入端口10可以单独地或者结合至少一个其他特征包括三个缝合孔66,该三个缝合孔66可以包括由本公开所考虑的进入端口的至少一个可识别的特征。此外,如图16所示,出口导杆31可以从侧壁100延伸。
在由本公开所考虑的进入端口的又一实施方案中,图17示出进入端口10的立体视图,其中盖体14和基部16当沿配接线15被相互组装时,形成绕进入端口10的边缘的至少部分延伸的凸缘构件或者唇状构件102。如图17所示,唇状构件102基本上绕进入端口10的边缘延伸,邻近盖体14和基部16之间的配接线15。这样的构件可以包括由本公开所考虑的进入端口的至少一个可识别的特征。因此,可以理解的是,盖体14和基部16之间的边缘不连续部分可以大体上沿二者之间的配接线15被形成。在如图7所示的进入端口的实施方案中,悬伸缘构件76可以包括边缘不连续部分或者在如图17所示的进入端口的实施方案中,唇状构件102可以包括边缘不连续部分。
在由本公开所考虑的进入端口的又一实施方案中,图18示出进入端口10的立体视图,其中至少一个侧表面50的至少一部分是凹形的。如图18所示,侧表面50的凹形区域106是凹面。凹面部分(即,凹形区域106)可以被呈现在如本文所示的任一实施方案中的进入端口的侧表面的至少一部分上,而不受限制。因此,由本公开所考虑的进入端口的至少一个侧表面50使其至少一部分是凹形的,这是用于识别由本公开所考虑的进入端口的至少一个可感知的特征的一个示例性的实施例。
在由本公开所考虑的进入端口的又一实施方案中,图18示出进入端口10的立体视图,其中至少一个侧表面50的至少一部分是凹形的。如图18所示,侧表面50的区域106是凹面。凹面部分可以被呈现在如本文所示的任一实施方案中的进入端口的侧表面的至少一部分上,而不受限制。因此,由本公开所考虑的进入端口的至少一个侧表面50使其至少一部分是凹形的,这是用于识别由本公开所考虑的进入端口的至少一个可感知的特征的一个示例性的实施例。
在由本公开所考虑的又一实施方案中,图19示出大体上如参照图6A和6B所述的被配置的进入端口10的立体视图。更具体地,如图19所示,拉长的本体20ER包括从进入端口10的上部形貌61以成弓形的方式向下(即,朝向如图1A和1B所示的参考平面11)延伸的侧表面50ER。这样的配置可以提供具有拉长的侧部分的进入端口10的拉长的本体20E。
从由本公开所考虑的进入端口的上述各种实施方案应当理解的是,许多变体、改变或者不同的特征可以被本公开所包含。因此,本公开不限于上述的数种示例性实施方案。
例如,如图20所示,图20示出由本公开所考虑的进入端口10的顶部正视图,进入端口10可以包括至少部分地截断侧表面50之间的弧形边32的侧壁100、从侧壁100延伸的出口导杆31以及凹形区域106和弓形表面50R中的至少一个。此外,如图20所示,缝合孔66可以被这样设置,以在皮下植入之后识别该进入端口10。
此外,本公开考虑的是,具有在本质上是多边形的外部几何结构的进入端口。具体地,本公开考虑的是,由本公开所考虑的进入端口可以呈现大体上为三角形的外部。因此,如图21所示,本体20可以呈现大体上为金字塔的形状或成锥形的形状(即,由于多边形的每一侧均朝向公共的顶点延伸,该多边形的基部具有多个表面)。一般地,进入端口10的本体20T可以在大体上为三角形的基部和相对较小的大体上为三角形的上基部之间延伸。因此,进入端口10的外部可以基本上由具有弧形边32在其间延伸的三个侧表面(例如,50、50R、102、50E)限定。此外,进入端口10的上部形貌61可以由上表面60与侧表面54和圆角区域30结合限定。这样的配置可以提供具有可以通过触按被感知的至少一个特征的进入端口。
图22和23示出进入端口的另一实施方案的立体视图和顶部正视图,该进入端口包括大体上为三角形的外部几何结构。更具体地,如图22和23所示,盖体14和基部16(共同形成壳体)可以锁定间隔件118以形成进入端口10。此外,出口导杆31可以包括导杆基部,该导杆基部可以被设置在形成于基部16中的出口凹陷93中,并且被密封到该出口凹陷93。出口导杆31可以与形成于进入端口10中的腔流体连通。可选地,缝合插件89可以被设置在形成于基部16中的缝合腔91中。缝合插件89可以包括柔韧的材料(例如,硅有机树脂(silicone)、橡胶等),该柔韧的材料可以在将进入端口10(即,基部16)耦合到患者的缝合过程中提供一定程度的弹性。更加详细地,进入端口10的侧边缘95(例如,一个或更多个侧壁)可以大体上为三角形的。因此,盖体14和基部16可以共同形成进入端口10的大体上为三角形的壳体或本体。再者,本公开考虑的是,侧边缘95可以增加或减少(例如,以成锥形或成弓形的方式形成)盖体14的上表面161和基部16的下表面151之间的截面尺寸。如图22和23所示,进入端口10的横截面(以基本上平行于基部16的下表面151的选定平面所获得的)可以越邻近基部16的下面表15越大,并且相对地可以越邻近盖体14的上表面161越小。
此外,图24示出进入端口10的横截面的简化表征。如图24所示,进入端口10的侧边缘95可以限定在相关联的顶点区域101之间延伸的三个侧区域103。此外,在一个实施方案中并且如图24所示,侧边缘95可以限定基本上为等边三角形的形状。如本领域普通技术人员将理解的,侧区域103可以以成弓形的方式在相关联的顶点区域101之间延伸;因此,侧区域103可以形成大体上为三角形的“侧边”。此外,尽管顶点区域101是圆形的,可以理解的是,这样的顶点区域101在邻接的侧区域103之间形成相交部分(intersection)。因此,本领域普通技术人员将理解的是,如本文所使用的短语“大体上为三角形”包含其中邻接的边相交的任何大体上为三条边的几何结构,而不受限制。例如,短语“大体上为三角形”包含三条边的多边形、圆弧三角形、等边三角形等,而不受限制。
本公开还考虑的是,由本公开所考虑的进入端口的至少一个特征可以不是在视觉上或者通过触按可察觉的,而是可以以其他方式可察觉的。例如,本公开考虑的是,进入端口的至少一个特征可以是通过成像技术(例如X-射线或者超声波)作用可见的。例如,在一个实施方案中,金属构件(例如,板或其他金属几何结构)可以被由本公开所考虑的进入端口包括。如可以理解的是,这样的金属构件可以基于如下内容被表征,通过将进入端口暴露于X-射线能量生成X-射线,而同时将X-射线敏感胶片暴露于穿过该进入端口的X-射线能量。此外,本公开考虑的是,进入端口的金属构件的尺寸、形状或尺寸和形状二者可以被配置用于加强进入端口的识别。例如,假设金属构件包括金属板,尺寸、形状或二者可以被选择性地定制以进行进入端口的识别。类似地,由本公开所考虑的进入端口的构件可以被定制以通过超声波作用进行检测。这样的构件可以包括外部形貌特征。在另一实施方案中,这样的构件可以包括具有形成接口界面的两种或更多种材料的复合结构,该接口界面可以通过超声波成像被识别。
通过由本公开所考虑的成像技术作用可见的特征的一个示例性实施方案在图52、53A以及53B中被示出。图52描绘进入端口10的底部立体视图。图53A示出进入端口10的顶部视图,而图53B示出该进入端口的底部视图。图52、53A以及53B中的进入端口10在一定程度上类似于如图22和23中所见的进入端口10,该进入端口10包括合作限定本体的盖体14和基部16。然而,在本示例性实施方案中,如图52和53B中可见的,基部16的下表面151包括标识特征200。要考虑的是,标识特征200可以为一个或更多个字母数字字符,例如所描绘的“CT”。此外,本公开考虑的是,其他标记的使用,例如一个或更多个标志、图形、字符、设计及其组合等。标识特征200可以为任何尺寸、形状或者为任何的尺寸和形状二者,以针对该进入端口的各种特性中的一个或更多个的特定识别定制该标识特征。具体地,在一个实施方案中,标识特征200可以向操作者传达关于所植入的进入端口的动力可注入性的信息。在本实施方案中要注意的是,标识特征被限定为凹陷的特征,然而在其他实施方案中,该标识特征可以以如下所论述的其他方式被限定。
如上所述的,图53A描绘进入端口10的顶部视图。要注意的是,标识特征200在没有成像技术的作用下,通过盖体14的上表面161或通过间隔件118是不可见的。如在图53B中所见的,标识特征200的字母数字字符,“CT”,以镜面反向的方式被雕刻在基部16的下表面151上。“CT”是以镜面反向的方式被雕刻的,以致当成像技术(例如X-射线成像)被用来识别皮下植入的进入端口时,该“CT”将在适当的方向上是可视的。通过以镜面反向的方式将期望的标识特征雕刻在进入端口的底面上,操作者将能够确定在被植入后该端口是否存在问题,例如,当在患者体内时该进入端口是否已经翻动(flip)或者是否变得定向有误(mis-oriented)。因此,如果该标识特征看起来是成镜面反向的,或者在X-射线图像中是歪斜的,则该操作者可以在试图使用该进入端口之前纠正该问题。
在一个实施方案中,雕刻技术适合用于由固体金属构成的进入端口,例如钛、不锈钢或者通常为不透射线的(radiopaque)(即,在充足的厚度下X-射线是无法透过的)其他材料,然而,在仅有端口的一部分包括金属材料(例如,金属板)的进入端口中也是有用的。如在植入患者之后通过X-射线成像所见的,图54A-54C是图52的进入端口10的典型图像,该进入端口10包括钛或其他金属材料。如图52和53B中所见的,进入端口10包括标识特征200。由于进入端口10的相对厚度,围绕为流体腔的腔36的腔边缘36A的基部16和盖体14的材料基本上是X-射线无法透过的,并且因此在图54A的X-射线图像中表现为相对暗。然而,在腔边缘36A中的通过腔基部220(如图55中所见)的进入端口10的材料与通过盖体14和基部16的材料相比是相对较薄的。因此,当创建标识特征200时,材料附加的薄性使该标识特征能够比该腔基部的周围材料在X-射线成像的情况下,表现出相对更多的射线照相透射。要注意的是,图54A中的标识特征200在适当的方向上是可视的,指示该进入端口没有翻动。
图54B和54C是进入端口10的标识特征200的附加的典型X-射线图像,其中该进入端口分别以约20和50度角倾斜。因此,标识特征200对于确定进入端口10在被植入后的相对方向也是有用的。
图55示出于图52中的进入端口10的线55-55处获得的截面视图。在该实施例中,标识特征200被设置于间隔件118和腔36之下。图56A和56B进一步描绘凹陷的标识特征200的可能的切割轮廓的放大截面视图。图56A示出被雕刻在基部16的下表面151上并且出于美学目的被使用且便于制造的圆形的雕刻轮廓201。然而,为了使在成像技术下所限定的对比度相对更多,如图56B中可见的,锐边的雕刻轮廓202可以被使用。要注意的是,可以采用各种凹陷的截面轮廓。本公开进一步考虑的是,尽管在此论述的是雕刻,然而可以使用标记该标识特征的其他方法,例如铣削、机加工、化学或激光蚀刻、模制、冲压等。
无论所使用的切割轮廓是什么,基本上利用更大的雕刻深度X来获得更佳的对比度。然而,最佳的雕刻深度X将取决于整体腔基部220的厚度,如图55所示,腔基部220是腔36正下方的基部部分。例如,在包括钛的进入端口的实施方案中,如果腔基部220的整体厚度约为0.020″,则在一个实施方案中,可以通过将标识特征200雕刻为在约0.009″和约0.011″之间的深度X(图56A、56B)来获得用于X-射线成像目的的足够的对比度。在包括钛的进入端口的另一示例性实施方案中,其中腔基部220的整体厚度约为0.030″,可以通过将标识特征200雕刻为在约0.015″和约0.021″之间的深度X来获得足够的对比度。本领域的普通技术人员将理解的是,雕刻的标识特征的深度可以在很大程度上被改变,以符合产品的安全需求而仍处于本公开所考虑的范围内。此外,标识特征的深度X可以根据该特征在该进入端口上的位置、要通过成像技术穿透的材料的厚度、被包括在该进入端口中的材料的类型等而改变。
本公开还考虑的是,在金属的或其他不透射线的进入端口中使用标识特征可以被应用于具有各种可能的配置的进入端口,例如在图57A-58C中所见的。图57A-57C描绘一个这样的实施方案,其中进入端口10在基部或本体116的下表面251上包括标识特征200。图57A-57C中的进入端口10包括固位环(retaining ring)230,该固位环230在腔36上将间隔件118密封到基部或本体116。在一个实施方案中,固位环230被压入装配到基部或本体116中,以将间隔件118保持于适当的位置。图58A-58C示出又另一实施方案,其中进入端口10在腔基部220上包括标识特征200,并且其中该腔基部被配接到盖体114的下表面252并与该下表面252齐平,以限定本体。在特定实施方案中,腔基部220被压入装配合到盖体114中,然而还可以采用其他的配接配置。
在由本公开所考虑的另一实施方案中,图59A和59B示出标识特征200的位置也是可以改变的。不是将标识特征200放置在腔36下,可能的是将该标识特征放置在进入端口10的另一部分下,例如在出口导杆31下并且在间隔件插件89之间,即邻近该进入端口底面的外边缘。尽管在该位置处的标识特征200上的该进入端口构造的整体厚度大于被雕刻在腔36下的情况,位置上的变化允许相对更深的雕刻,这将提高对比度而不带来使腔基部220过薄的风险。此外,在一个实施方案中,可能的是通过复合地雕刻到底面和顶面二者中来限定该标识特征,从而该雕刻是垂直对齐的。这使得剩余的材料厚度能够在很大程度上被减小,以提供穿过该标识特征的相对更多的射线照相透射。
此外,本公开考虑具有任何各种期望的标识特征或组合的进入端口,用于指示进入端口的动力可注入性或其他方面或特性。具体地,图60A-61B根据示例性实施方案描绘不同类型的标识特征200。图60A-60B描绘标志性标识特征200。图61A-61B描绘包括标识特征200组合(即字母数字标识特征200A和图形化标识特征200B)的进入端口10的示例性实施方案。图形化的或标志性的标识特征还可以被用来帮助指示该端口的方向或者用于任何其他期望的理由。通过本公开要理解的是,其他标志、图形、标记以及字母数字字符基于各种进入端口配置,既可以单独使用也可以以任何相互组合的方式使用。
在附加的实施方案中,该标识特征可以被限定在进入端口10的腔36的内部底面36B上,或者除了被提供在底面251上的标识特征200之外被限定。在另一实施方案中,围绕期望的不透射线的字母数字字符、标志、图形等的限定边缘的材料可以被移除而不是移除该期望的特征形状本身,以限定该标识特征的“正”浮雕图像。这样的正浮雕标识特征例如可以被限定在进入端口本体的下表面上或者在该腔的内部底面上。
除了由本公开所考虑的各种类型的标志、图形、标记以及字母数字字符之外,图62A-63C公开通过X-射线或其他适合的成像技术是可见的进入端口上的标识特征的附加的示例性实施方案。具体地,本公开考虑使用“抠出的(shelled-out)”腔204,其中进入端口10的部分是被挖空的。这导致抠出的腔204从基部或本体116的下表面251向内延伸,或者从如文本所描述的其他实施方案的相应端口下表面向内延伸,该相应端口下表面包括如图151中那样的基部16的下表面151以及如图58A-58C中那样的盖体114的下表面252。这是通过移除围绕腔36的材料而不破坏腔边缘36A或进入端口10的外侧表面250来完成的。如图62B中所见的,肋240可以被保留以支撑进入端口10的剩余“带壳的(shelled)”框架。这样的腔204的限定提供通过X-射线成像是可以被识别的进入端口10的不透射线性上的相对差异。这样,腔204可以被设置来限定图形或形成用于识别进入端口10的方面或特性的记号。注意的是,在其他实施方案中,该腔可以被限定以从该进入端口的其他表面(包括其顶面或侧面)延伸。
在由本公开所考虑的又一方面中,所考虑的是,可以使用通信技术,其中信息被由本公开所考虑的进入端口包含。一般地,通信装置(例如,无线电信标、发光元件、超声波发射换能器等)可以被嵌入或者附着到由本公开所考虑的进入端口。这样的通信装置可以被配置来响应于给定推动力(impetus)而传输信息。更具体地,本公开考虑的是,由本公开所考虑的进入端口可以被暴露于请求信号(例如,声波、冲击波或加速度波、光波、无线电波等)。这样的请求信号可以导致该通信装置通过声波、光波、无线电波或者其他本领域已知的方式从中传输信息。这样的信息可以被用来识别由本公开所考虑的进入端口。
在一个示例性的实施例中,考虑的是,可以采用射频识别技术来识别由本公开所考虑的进入端口。具体地,所谓的有源RFID标签是由内部电池供电的并且是典型的读/写装置。目前,耦合到适当的低功率电路的适合的电池根据工作温度和读/写周期与使用情况,可以确保长达十年或更多年的功能。所谓的无源RFID标签在没有单独的外部电源的情况下工作并且获得从识读装置生成的工作电力。无源RFID标签通常利用无法被修改的一组唯一的数据(一般是32至128位)进行编程。只读标签可以如与线性条码可比的标识符那样工作,该线性条码可以包含选定产品的特定信息。因此,无源RFID标签可以比有源RFID标签轻的多,便宜的多,并且可以提供几乎无限的工作寿命。折中之处在于,其具有比有源标签更小的识读范围并且需要更高供电的识读装置。
RFID方案的一个优势在于该技术的非接触的、无视线的性质。标签可以穿过各种物质(例如,雪、雾、冰、颜料、沉积的污垢)并且在其他光学识读技术可能会不太有效的其他在视觉和环境上具有挑战性的条件下被识读。RFID标签还可以在具有挑战性的情况下被快速识读,大部分情况下在少于约100毫秒内响应。
现在一般地参照图64-75C,描述附加的实施方案,其中进入端口包括至少一个通过成像技术(例如,X-射线和透视检测)作用可见的标识特征,以便利在被植入患者体内之后进入端口的至少一个属性或特性的识别。要理解的是,要被描述的实施方案可以被单独地或与文本所描述的其他标识特征一起被包括,并且可以与具有各种尺寸、形状以及配置上的其他变体的进入端口一起使用。从而,文本所描述的实施方案仅仅是本公开的原理的实施例。
图64示出包括基部316和间隔件318的进入端口310,间隔件318覆盖由该基部限定的仓(reservoir)。间隔件318包括多个触按***(bump)320,用于使得在进入端口310已经被皮下植入之后临床医生能够对该间隔件进行外部手指触按和定位。端口310包括固位环330,用于将间隔件318锁定和固位在该端口仓顶部的适当位置。在本实施方案中,端口基部316和固位环二者均为金属物质,例如包括钛,然而在其他实施方案中可以使用其他适合的材料。
在本实施方案中,固位环330包括标识特征200用于在端口310被植入之后识别其预先确定的属性或特性。具体地,固位环330包括拼作“POWER INJECTABLE(动力可注入的)”的字母数字字符标识特征200A,这指示端口310是能够动力注入的。在一个实施方案中,该字母数字字符通过蚀刻被嵌入或者被适当地限定在固位环330中,以提供字符和周围金属固位环材料之间的相对厚度差,因此当端口310利用X-射线成像技术被成像时,提供相应的射线拍照对比度。该对比度使得该字母数字字符能够成为在X-射线下是可视的,并且因此是可由观看该X-射线的临床医生辨识的,因而使得关于标识特征200的该端口属性或特性能够被确定。
注意的是,字母数字标识特征200A可以以许多适当的方式(包括蚀刻、雕刻等)被限定在固位环330上,并且该字符可以部分地或完全地通过该固位环被限定。再有,所使用的具体字符或文字可以不同于此处所描述的内容。确实,其他的字符、图形、标志等可以被用在标识特征200中。可选地,如图64所示,该标识特征可以以负浮雕来限定,或者如果期望的话可以以正浮雕来限定。
此外,在其他实施方案中,固位环的该标识特征可以根据该端口的配置以其他方式来配置。例如,在该端口本体包括非金属材料的实施方案中,该标识特征可以包括涂敷到该固位环表面的不透射线的印墨,以形成该字母数字或其他字符或特征。在其他实施方案中,该标识特征除了被包括在该固位环上之外,还可以被包括在该端口的部分或表面上。
图65包括根据另一实施方案配置的金属端口310的金属固位环330,其中该固位环限定标识特征200,该金属固位环330包括多个交叠部分330A,每个交叠部分交叠由该固位环固位的间隔件318的一部分。在图65中,固位环330的交叠部分330A合作来大体上限定三角形,该三角形提供相对于该固位环下的金属端口310的部分的射线照相对比度。和前面一样的,当端口310利用X-射线成像技术被成像时,这提供相应的射线照相对比度,使得该三角形是能够由观看该X-射线的临床医生根据不透射线的轮廓可辨识的,以确定关于要被确定的标识特征200的预先确定的端口属性或特性。在其他实施方案中,该固位环除了此处所示的三角形之外还可以限定其他形状。此外,如果期望的话,字符、标志或其他图形可以被限定于或包括在该固位环的该交叠部分上。
图66A-66D描绘与包括用于识别进入端口在被植入患者之后的预先确定的属性或特性的标识特征相关的各种细节。具体地,这些附图描绘双仓进入端口410,该进入端口410包括可配接到基部416的盖体414以及置于该盖体和基部之间的两个间隔件418。缝合插件422与端口410一起被包括。根据本实施方案,端口基部416的底面416A包括用于识别被皮下植入的端口的标识特征200。如在图66B中最佳可见的,本实施方案中的标识特征200包括不透射线的标记,该不透射线的标记包括由双三角边界限定轮廓的字母“C”和“T”,然而许多不同的字符、图形和/或组合配置也是可能的。例如,除了将该进入端口识别为动力可注入的之外,本文所描述的这个和其他标识特征可以被用来标明批次编号、医院标识、端口品牌等。
标识特征200的不透射线的标记可以包括混合有基于印墨的标记的金属粉末。具体地,在一个实施方案中,该不透射线的标记包括以三份钨粉末对一份印墨的比率混合有由马萨诸塞州的西汉诺威的Gem Gravure公司生产的1020黑丝标记印墨的钨粉末。在一个实施方案中,这两种组份的混合可以包括球混合(ball mixing),以确保良好的组份结合。再者,添加剂可以被添加到该混合物中以获得适当的混合物粘性。
在其他实施方案中,粉末对印墨的比率可以由以上所述的而被调整,包括例如2∶1、4∶1和5∶1的比率。理想的比率将根据混合物中所采用的材料类型、所期望的图像密度、粉末颗粒尺寸、涂敷到该端口的混合物的量等而改变。在其他实施方案中,可以使用其他医疗级印墨或适合的液体,以及其他生物可兼容的金属粉末或适合的不透射线的材料。在一个实施方案中,陶瓷(例如氧化锆粉末)可以与标记印墨混合以提供该不透射线的标记。印墨稀释剂以及本领域技术人员意识到的其他适合的物质也可以被添加到该混合物中。
如在图66B中所示,在本实施方案中形成标识特征200的基于印墨的不透射线的标记被包括在基底440上。在一个实施方案中,基底440包括与端口410中所包括的材料基本上相同的材料。具体地,在一个实施方案中,端口410和基底440二者包括以商标DELRIN出售的乙酰树脂(acetyl resin),然而要理解的是,其他适合的材料也可以被用于该基底和端口。
基底440被用作该不透射线的标记可以被安置于其上的基部,为注射模制工艺期间该基底和标记结合到端口410中做准备,以将该不透射线的标记封装在该模制的端口中。具体地,在一个实施方案中,包括上述的印墨/粉末混合物或其他适合物质的该不透射线的标记首先经过任何可接受的工艺被安置在基底440的表面上,包括移印(pad printing)、手动或自动喷涂、丝网印(silk screening)、使用模板等。为改善该印墨/粉末混合物的粘合性,在一个实施方案中,该基底可以被等离子处理或电晕处理。
一旦该不透射线的标记已经被应用到基底440,该基底被加载到例如图66C所示的模具中,图66C描绘设置在模具442的一部分的腔444中的该基底。基底440被设置在模具腔446中,从而该不透射线的标记面向将成为端口410的中心的部分。在一个实施方案中,基底440通过真空辅助***被保持在模具腔444中的适当位置;在其他实施方案中,如果必要的话,可以采用临时机械固定装置。模板包括被选择尺寸以使得该基底能够穿过的孔,在一个实施方案中,该模板可以被用来辅助技术人员以适当的方向将基底440放置在模具腔444中。
端口410然后通过注射模制工艺来制造。因而,基底440经过注射模制工艺被嵌件模制到端口410中,这将基底440结合(bond)到端口410的模制的本体,从而将标识特征200的不透射线的标记封装在该端口中,并且防止其不经意的移动。此外,如图66D中所见,由于基底440相对较薄,在被植入之前该标识特征从端口410的外部通过该基底仍为可视的。在一个实施方案中,基底440的厚度在约0.002英寸到约0.015英寸的范围,然而可以以可接受的方式使用其他厚度。稍后,当端口410被植入并且在X-射线下被成像时,标识特征200在X-射线图像中将是可视的,并且可用于识别该植入的端口的属性或特性。
要理解的是,在其他实施方案中,该基底可以被配置为被设置在该端口的其他区域中。在其他实施方案中,可以使用其他基底材料。例如,在一个实施方案中,该基底可以包括以商标TYVEK出售的织造的高密度聚乙烯。在这种情况下,由于该嵌件模制工艺,基底440并不是永久性地被粘合到端口410,而是在模制工艺完成后基底440是被移除的。然而,该不透射线的标记印墨/粉末混合物初始地被包括在织造的基底440上,被整合到该端口本体中并且在模制并移除基底后仍与端口410保持在一起,以起到标识特征200的作用。在一个实施方案中,边或凸缘可以被包括在该基底上以便利其在模制后从该端口的该基底分离。在另一实施方案中,该印墨/粉末不透射线的标记混合物被允许在施加于基底440上之后变干,以在该嵌件模制工艺期间改善与端口410的粘合。除了此处明确描述的那些以外,可以使用其他适合的材料作为该基底。在另一实施方案中,没有使用基底并且该印墨/粉末不透射线的标记混合物在端口410于模具中被模制之前被直接涂敷到该模具表面。
图74A和74B描绘根据另一实施方案配置的基底440和标识特征200的细节,其中该基底形成该端口基部的一部分。升高的表面440A被包括在该基底上,并且不透射线的标记(例如混合的标记印墨和不透射线的粉末)被包括在该升高的表面上,以限定标识特征200。可以以数种适合方式中的任何一个实现该不透射线的标记的涂敷,包括通过压印(stamp pad)或夯实印(tamp pad)、喷墨印刷、物理或化学沉积等接触式涂敷。
然后,基底440与所包括的标识特征200一起可以被嵌入到模具中并且被嵌件模制以形成进入端口的基部616的部分。一旦制造完成该端口,当前被封装在该基部内的不透射线的标识特征200提供该端口预先确定的属性或特性的期望的识别。
现在参考图67,图67根据一个实施方案描绘用于进入端口(例如塑料端口)的另一标识特征。具体地,图67的端口410包括被限定在端口基部416的底面416A上的腔446。在一个实施方案中,腔446被限定为约0.010英寸的深度,然而还可以根据期望和端口配置使用其他深度。腔446被填充有不透射线的填充材料448。腔446利用预先确定的设计或配置被成形,以在被填充有不透射线的填充材料448时形成标识特征200,从而使得在被植入之后端口410的预先确定的属性或特性能够通过X-射线成像被识别。在本实施方案中,填充材料448包括混合有两份的以SILASTIC商标Q7-4840出售的硅有机树脂的钨粉末,该两份的硅有机树脂是以等量的方式从密西根州的米德兰市的陶-康宁(DowCorning)公司可获得的,即等份的A份硅有机树脂、B份硅有机树脂以及钨粉末。当然,也可以采用其他适合的材料。例如,可以使用钛来替代钨,并且可以使用生物兼容的聚氨酯胶黏剂来替代硅有机树脂。
在一个实施方案中,填充材料448通过加压注射器(例如电子流体分配器)被注入到腔446中,然而也可以采用其他适合的技术,包括通过注射器手动填充。任何过量的填充材料448可以在填充后从该端口基部底面416A被移除,并且该填充材料可以被允许用于治疗。要注意的是,在其他实施方案中,如图67所示,该端口的该底面除了该基部之外还可以包括该端口的其他部分或者可以包括该端口的其他部分而不包括该基部。
图68A-68C示出用于在可植入的进入端口(例如,塑料端口)的弹性间隔件468上提供标识特征200的一个实施方案的细节,其中该间隔件包括在X-射线成像下是可视的不透射线的部分,以提供关于该间隔件自身和/或该间隔件被设置于其中的进入端口的属性或特性的信息。在图示说明的实施方案中,该不透射线的部分被限定为绕间隔件468的上外边缘设置的环形部分470,以在端口使用期间不干扰通过针对该间隔件的刺穿。如在图68C中最佳可见的,该环形部分不在深度上延伸通过该间隔件外部分的厚度,但在其他实施方案中,该不透射线的部分的厚度、尺寸以及位置可以根据该间隔件而改变。
在本实施方案中,不透射线的环形部分470包括加有硫酸钡的硅有机树脂,而间隔件468的剩余部分是未加有硫酸钡的硅有机树脂。在其他实施方案中,可以与硅有机树脂或其他间隔件材料一起采用其他适合的不透射线的材料。在一个实施方案中,图68A-68C的间隔件468可以通过两部件模制工艺被形成,其中环形部分470分离于间隔件468的余下部分被加工,然后这两个部件通过适合的粘合剂、机械固定等被附着在一起,以形成图68A-68C中所示的构造。
在另一实施方案中,该间隔件468经过共模制(co-molding)工艺被一体地加工,其中分离的注入头被用于模具腔中,以注射模制具有一个或更多个头的环形部分470,以及具有分离的头的间隔件468的余下部分。因此,这些和其他加工方法被考虑在本公开的精神内。
结合图68A-68C所论述的原理在图69中所示的一个实施方案中可以被扩充,其中包括设置于相应的缝合插件孔524中的弹性缝合插件522的端口510被这样配置,以致该缝合插件包括不透射线的材料,例如图68A-68C的间隔件468中所采用的加硫酸钡的硅有机树脂或其他适合的不透射线的材料。这样配置的,该缝合插件提供标识特征200,该标识特征200在X-射线成像下是可视的以提供关于端口510的属性或特性的信息。在一个实施方案中,端口510可以包括不透射线的缝合插件522和间隔件468二者,该间隔件468包括不透射线的部分470以提供附加的识别能力和/或提供关于在患者体内的该端口的方向的信息。除了硫酸钡之外,该缝合插件可以包括钨、钽或其他适合的不透射线的材料。在又另一实施方案中,一个或更多个不透射线的珠体(bead)可以被设置在该端口本体中以提供X-射线下的相似端口可视性。
在一个实施方案中,该端口的间隔件、缝合插件或者其他部分可以包括紫外光敏感的材料。该紫外光敏感的材料可以被涂敷到该端口部件的表面或者可以被浸入该部件。在该端口被植入之后,紫外光被导向通过患者的皮肤以入射到该端口的紫外线敏感材料上,这导致该材料在可见光的情况下发荧光,该荧光通过该患者的皮肤是可见的,因此识别该端口和/或其预先确定的属性或特性。
要理解的是,除了那些已经描述过的实施方案之外,不透射线的标识特征可以以其他方式被包括或者与端口相关联。关于这一点的实施例可以存在于图70-72所描绘的实施方案中。例如在图70中,标识标签550被示出,该标识标签550包括具有用于使得该标识环能够被附接到导管的裂缝554的环部分552,该导管被可操作地附接到端口的导杆。标识标签550还包括面部分556,不透射线的标识特征200可以被放置于该面部分556上,以通过X-射线成像的是可视的,来识别该端口的预先确定的属性或特性。该标签可以以各种不同的形状和配置被设计。例如,该标签可以被包括作为导管固定装置的一部分,以将导管的端部锁固到该端口的导杆。
在图71中,端口510被示出具有导管固定装置540,该导管固定装置540被用来固定导管512的端部和该端口的导杆530之间的连接。导管固定装置540的本体542被配置为包括标识特征200,以通过X-射线成像是可视的,来识别该装置被附接到的端口的预先确定的属性或特性。再者,该导管固定装置和标识特征的形状、尺寸以及特定配置可以由本文所示出并描述的内容改变。
在图72中,端口510被示出具有可操作地与之附接的导管512。导管512包括从其本体延伸的两个翼550,标识特征200被包括在这两个翼550上,以当在X-射线下被成像时提供该导管和/或端口的预先确定的属性或特性的可视的识别。当然,特定的标识特征以及该导管翼的数目和尺寸/配置可以由本文所描述的内容改变。
图73A和73B描绘不透射线的标识特征的又另一实施例,其中标识特征200被包括在由不透射线的材料(例如,钨或其他适合的材料)形成的***体570中。***体570适合用于放置在塑料或其他射线半透明的端口中,从而该***体在X-射线成像下是可视的,以识别该端口的属性或特性。定向箭头572提供该端口的定向的有用记号。通过检查箭头572的方向,观察端口***体570的X-射线图像的临床医生可以确定该端口在患者体内是否被翻动。除了这些之外,在其他实施方案中,指示端口定向的其他记号也可以被包括在该***体上。
除了图73A和73B中所示的,图75A-75C示出不透射线的***体的另一实施例的实施方式,该实施方式被包括来起到标识特征200的作用,以识别端口(如在本实施方案中所示的,包括塑料端口)的预先确定的属性或特性。具体地,不透射线的***体670被示出,被配置来置于端口710的盖体714和基部716之间。要注意的是,尽管此处所示的***体670被配置来装配在端口710的双流体腔712上,包括各种不透射线的组合物的其他***体可以以其他方式被配置为与端口一起被包括。此外,该端口可以限定一个、两个或更多个由间隔件718覆盖的流体腔,而不受限制。
如图75B中所示,***体670装配在端口710的流体腔712上,以搁置在端口基部716的部分上。这样放置的,***体670当基部716和盖体714被配接在一起以形成端口710时被夹于并固定在该基部和盖体之间。这样的配接可以通过超声波焊接、粘合剂等来实现。图75C示出***体670最终被置于基部716和盖体714之间。在端口710被植入患者之后,当随后通过X-射线被成像时,***体670是容易被看到的,因此使得该端口的预先确定的属性/特性(一个或更多个)能够被识别。
虽然出于图示说明由本公开所考虑的各方面的目的,特定的典型实施方案和细节已经被示出,对本领域技术人员来说将理解的是,可以对文本所公开的方法和设备进行各种改变,而不脱离由本公开所考虑的由所附的权利要求书限定的范围。例如,可以采用其他的进入端口尺寸和形状;并且各种其他实施方案和构造可以被用来形成由本公开所考虑的进入端口的至少一个可识别的特征。具体地,图25-51图示说明进入端口10的数个附加的示例性实施方案。如从这些附图清晰可见的,进入端口10可以以许多形状和尺寸来形成,从而许多修改和改变对文本所描述并图示说明的实施方案中的任何一个都是可能的,而不脱离本公开的精神和范围。
Claims (20)
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;以及
固位环,所述固位环将所述间隔件固定到所述本体,所述固位环包括通过X-射线成像技术可见的标识特征,所述标识特征传达所述进入端口的至少一个属性的信息指示。
2.如权利要求1所述的进入端口,其中所述标识特征包括被限定在所述固位环的表面上的多个嵌入的字母数字和/或标志性字符。
3.如权利要求1所述的进入端口,其中所述标识特征指示所述进入端口是能够进行动力注入的。
4.如权利要求1所述的进入端口,其中所述标识特征由与所述间隔件的一部分交叠的所述固位环的至少一个交叠部分限定,从而限定预先确定的不透射线的轮廓。
5.一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;以及
附接到所述本体的基底,所述基底包括内表面,在所述内表面上设置有不透射线的标识特征,以致所述标识特征被封包在所述进入端口的所述基底和所述本体之间。
6.如权利要求5所述的进入端口,其中所述基底包括乙酰树脂或高密度聚乙烯。
7.如权利要求5所述的进入端口,其中所述端口的所述基底和所述本体包括基本上类似的材料。
8.如权利要求5所述的进入端口,其中在所述基底被附接到所述进入端口的所述本体之后,所述标识特征通过所述基底是可视的。
9.如权利要求5所述的进入端口,其中所述基底与所述进入端口的所述本体一起被嵌件模制,并且其中所述标识特征包括混合有印墨的金属粉末。
10.如权利要求9所述的进入端口,其中所述金属粉末为钨粉末,并且其中所述钨粉末以三份钨粉末对一份印墨的比率与所述印墨相混合。
11.一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:
将基于印墨的不透射线的标识特征放置在模具腔中;以及
在所述模具腔中模制所述进入端口,以致所述标识特征永久性地结合到所述模制的进入端口的本体。
12.如权利要求11所述的制造所述进入端口的方法,其中放置所述不透射线的标识特征的步骤还包括:
将所述基于印墨的不透射线的标识特征安置在基底上;以及
将所述基底放置在所述模具腔中。
13.如权利要求12所述的制造所述进入端口的方法,其中所述基于印墨的不透射线的标识特征被包括在基底上,并且其中所述方法还包括:
在模制之后移除所述基底,以致基于印墨的不透射线的标识特征保留在所述进入端口的所述本体上。
14.一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;
凹陷,所述凹陷被限定在所述本体的表面上;以及
可注入的不透射线的材料,所述材料被设置在所述凹陷中,所述材料限定通过X-射线成像技术可见的标识特征,所述标识特征与所述进入端口的至少一个属性相关。
15.如权利要求14所述的进入端口,其中所述不透射线的材料包括混合有金属材料的硅有机树脂。
16.如权利要求15所述的进入端口,其中所述硅有机树脂包括两份的硅有机树脂,其中所述金属材料包括钨粉末,并且其中等份的第一份所述硅有机树脂、第二份所述硅有机树脂以及所述钨粉末相混合。
17.一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:
至少一个弹性部件,所述至少一个弹性部件包括不透射线的标识特征,所述标识特征与所述进入端口的至少一个属性相关。
18.如权利要求17所述的进入端口,其中所述弹性部件包括缝合插件和所述进入端口的间隔件中的至少一个。
19.如权利要求18所述的进入端口,其中所述标识特征包括如下列中的至少一个:硫酸钡、钨粉末以及钽。
20.如权利要求17所述的进入端口,其中所述标识特征包括在所述进入端口的间隔件上的环形部分,所述环形部分包括硫酸钡并且与所述间隔件的剩余部分被一体地形成。
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CN106102819B (zh) * | 2014-03-11 | 2019-10-29 | 特兰斯库坦股份公司 | 用于脉管和腹膜通路的装置和用于血液透析的装置 |
CN110621215A (zh) * | 2017-04-28 | 2019-12-27 | 巴德血管***设备公司 | 可植入的唯一器械标识和检测*** |
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Also Published As
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CN105664353A (zh) | 2016-06-15 |
US20120259296A1 (en) | 2012-10-11 |
MX337695B (es) | 2016-03-15 |
BRPI0919890B8 (pt) | 2019-09-24 |
US20100069743A1 (en) | 2010-03-18 |
MX2011004499A (es) | 2011-05-24 |
EP3978066A1 (en) | 2022-04-06 |
ES2906416T3 (es) | 2022-04-18 |
CN102271737B (zh) | 2016-02-17 |
EP2346553A1 (en) | 2011-07-27 |
WO2010051494A1 (en) | 2010-05-06 |
US8202259B2 (en) | 2012-06-19 |
EP2346553B1 (en) | 2022-01-19 |
BRPI0919890B1 (pt) | 2019-09-03 |
BRPI0919890A2 (pt) | 2017-04-04 |
EP2346553A4 (en) | 2017-06-14 |
US8998860B2 (en) | 2015-04-07 |
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