CN102421469B - 进入端口识别***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:本申请要求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的优先权,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)”的美国临时专利申请No.60/658,518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;以及
图63C示出图63A中所示的进入端口的端视图。
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.RTM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。
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 (14)
1.一种用于提供对患者皮下进入的进入端口(10),所述进入端口(10)包括:
金属本体(14、16),所述金属本体(14、16)限定流体腔(36),所述流体腔(36)是通过将针***穿过间隔件(118)而可进入的;以及
被包括在所述进入端口的底面上的标识特征(200),所述特征在所述进入端口皮下植入之后通过成像技术是可见的,所述标识特征识别所述进入端口的预先确定的特性,
其中所述标识特征被凹陷于所述进入端口的所述底面中,
其中所述凹陷标识特征具有圆形的或者锐边的凹陷的截面轮廓。
2.根据权利要求1所述的进入端口,其中所述标识特征被设置在所述端口流体腔下。
3.根据权利要求1所述的进入端口,其中所述标识特征邻近所述进入端口的所述底面的边缘。
4.根据权利要求1所述的进入端口,其中所述本体包括钛并且包括基部,所述基部限定所述进入端口的所述底面的至少一部分。
5.根据权利要求1所述的进入端口,其中所述标识特征被设置在所述金属本体的外部底面上。
6.根据权利要求1-5中的任一项所述的进入端口,其中所述标识特征是雕刻的。
7.根据权利要求1-5中的任一项所述的进入端口,其中所述凹陷标识特征包括雕刻特征并且相对于所述进入端口本体的其他部分是相对更X-射线可透射的。
8.根据权利要求1-5中的任一项所述的进入端口,其中所述成像技术包括X-射线成像技术。
9.根据权利要求1-5中的任一项所述的进入端口,其中所述预先确定的特性与所述进入端口的最大流率相关。
10.根据权利要求1-5中的任一项所述的进入端口,其中所述预先确定的特性与作为动力可注入端口的所述进入端口的标识相关。
11.根据权利要求1-5中的任一项所述的进入端口,其中所述标识特征包括下列中的至少一个:字母数字字符、标志、图形、标记,或者其任一组合。
12.根据权利要求1-5中的任一项所述的进入端口,其中当所述进入端口通过X-射线成像技术被成像时,所述标识特征指示所述进入端口的定向。
13.根据权利要求1-5中的任一项所述的进入端口,其中所述标识特征包括字母“C”和“T”。
14.根据权利要求1-5中的任一项所述的进入端口,其中所述凹陷的截面轮廓为矩形或半圆形。
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EP2416828B1 (en) | 2018-02-14 |
BRPI1013986B1 (pt) | 2019-12-10 |
MX359073B (es) | 2018-09-13 |
KR101743788B1 (ko) | 2017-06-05 |
CN104027861B (zh) | 2017-07-11 |
EP2416828A1 (en) | 2012-02-15 |
KR20170064551A (ko) | 2017-06-09 |
US20090204072A1 (en) | 2009-08-13 |
US20130225991A1 (en) | 2013-08-29 |
EP3412332A1 (en) | 2018-12-12 |
EP2416828A4 (en) | 2012-09-05 |
US7947022B2 (en) | 2011-05-24 |
BRPI1013986A2 (pt) | 2016-04-05 |
CN104027861A (zh) | 2014-09-10 |
US9603993B2 (en) | 2017-03-28 |
CA2757836C (en) | 2017-05-02 |
CA2757836A1 (en) | 2010-10-14 |
WO2010118144A1 (en) | 2010-10-14 |
JP2012523284A (ja) | 2012-10-04 |
MX2011010529A (es) | 2012-01-25 |
US20110311337A1 (en) | 2011-12-22 |
KR20120021304A (ko) | 2012-03-08 |
JP5798548B2 (ja) | 2015-10-21 |
EP3412332B1 (en) | 2020-03-04 |
CN102421469A (zh) | 2012-04-18 |
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