CN1657022A - 具有安装机构的可植入带 - Google Patents

具有安装机构的可植入带 Download PDF

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CN1657022A
CN1657022A CN2004100951056A CN200410095105A CN1657022A CN 1657022 A CN1657022 A CN 1657022A CN 2004100951056 A CN2004100951056 A CN 2004100951056A CN 200410095105 A CN200410095105 A CN 200410095105A CN 1657022 A CN1657022 A CN 1657022A
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R·T·拜伦
K·L·杨博尔
S·P·康伦
N·克劳福德
K·A·哈珀
L·斯普雷克尔迈尔
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Ethicon Endo Surgery Inc
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Abstract

一种用于在解剖通道，如胃或其他内腔周围放置的可植入带，具有位于在操作位置中相互固定各端上的内表面。一端可以包括一条另一端延伸通过的通道。一个横向元件可以从位于一端的表面延伸，并啮合另一端。

Description

具有安装机构的可植入带
相关申请
本申请要求于2003年6月27日申请的、专利申请号为60/483,353的临时专利申请为优先权，该在先申请公开的内容在此与本申请合为一体。本申请还参考并合并了下列申请日相同的在审美国专利申请：临时申请号60/507625(具有改进安装机构的可植入带，发明人：Byrum，Jambor，Albrecht)；申请号10/677088(具有横向安装机构的可植入带，发明人：Byrum，Jambor，Crawford)；申请号10/676368(具有非机械安装机构的可植入带，发明人：Byrum，Nuchols)；和临时申请号60/507612(具有可变形安装机构的可植入带，发明人：Byrum，Wiley，Conlon，Fender)。
技术领域
本发明总体上涉及一种用于环绕解剖通道(anatomical passageway)的外科上可植入带，特别涉及一个用于环绕胃部以达到控制肥胖目的的可调节胃带。本发明将被特别地描述为与用于可调节胃带的改进固定机构相关。
背景技术
自本世纪八十年代早期以来，对于胃的旁路和其他针对病态肥胖所做的不可改变的外科减肥治疗，可调节胃带提供了一种有效的选择。胃带缠绕在病人胃的上部，形成一个小于正常胃的内径的气孔，该气孔限制从上部流到胃下部的消化部分的食物。当气孔的尺寸合适时，容纳在胃上部的食品产生一种阻止吃得过多的饱胀感。
除了设定胃带直径的锁定位置外，胃带的可调性通常这样实现，与血压套袖相似，该胃带具有一个向内的可充气气球，流体如盐通过流体注射口进入该可充气的气球中，以获得理想的尺寸。典型地，当第一次放置于身体里时，该气球是紧缩的或仅被部分充气，以允许身体的适应和新带子位置周围的愈合。由于可调节胃带能在病人身体内维持一段长的时间，所以流体注射口通常被安装在皮下以避免感染，例如安装在胸骨的前面。在最初的皮下注入之后，根据病人的需要，外科医生可以通过放松或勒紧来调节带。在可调节胃带中流体数量的调节是通过插入一个Huber尖端针穿过皮肤进入注射口的硅酮隔膜来实现的。一旦针被移动，由于隔膜产生的压缩负荷就会使得隔膜密封孔。弹性导管连接在注射口和可调节胃带之间。
用于可调节胃带的固定机构必须提供一个胃部气孔的初始尺寸。一种公知的固定是缝合可调节胃带的末端。另一种公知的固定包括可调节胃带的一端终止于一具有外展部分的弹性导管中，该外展部分被牵引通过胃带第二端的开口，然后被缝合到保护胃部的带的环绕带部分上。在缝合确定位置后，注射口就被固定在一个适宜的位置上。
虽然这些公知方法在紧固胃带中是有效的，但仍然希望有进一步的改善，能简化临床移植过程，提供长期的可靠性，且便于重复调节和移动。
虽然过去缝合被认为是最可靠的连接，但更理想的是具有一种安全的固定机构，不需要缝合，也不需要很大的力来产生该安全固定。此外，使用腹腔内窥镜器械充分地抓紧和实行的固定是困难的。因此，对具有改善固定机构的可调节胃带存在显著的需要。
发明内容
本发明基于现有技术中出现的和其他问题，通过提供一种使用更小的力来连接的可调节胃带装置，从而使腹腔内窥镜工具的应用能够简便，并维持固定机构安全使用一段长的时间。
本发明的一个基本目标是提供一种具有反向内表面安装机构的可调节胃带。
本发明的另一个目标是提供一个易于可逆的可调节胃带，其可以在不降低固定机构保持强度的情况下被扣紧和放松。
本发明的另一个目标是提供一种具有纵向作用力的可调节胃带，其通过固定机构传导，在不引起分离的情况下该力可以相对增大，而结合力相对降低。
要达到以上的和其他的目标，根据本发明在此描述的目的，描述了一种具有反向内表面固定机构的可调节胃带，其中一个元件从被成型设置以啮合另一端的一端横向地延伸。根据一方面，该横向元件包括一接收另一端部分的通道。另一方面，该横向元件被位于另一端的开口接收。
本发明进一步新颖性的特征和其他目标将通过下面的细节描述、讨论和所附的权利要求并结合附图变得更加明显。
附图内容
附图，被合并到说明书中并作为说明书的一部分，阐述了本发明的实施例，并且和上述给出的本发明的总体描述及下面将给出的实施例的详述一起，用来解释本发明的原理。
图1是示出了一个环绕在胃上部周围的可调节胃带的简图。
图2是图1中可调节胃带沿2-2线的横截面图。
图3是结构上根据本发明具有一个反向内表面固定机构的可调节胃带的顶视图。
图4是图3中可调节胃带的反向内表面固定机构的局部放大透视图。
图5A-C是图3中所示的固定机构反向内表面末端接合的各个不同阶段沿纵向中心线的一系列局部放大横截面侧视图。
图6是具有反向内表面固定机构的可调节胃带的另一个实施例的局部放大透视图。
图7是图6所示可调节胃带的反向内表面固定机构处于连接位置上的放大局部透视图。
图8和9是根据本发明的反向内表面固定机构另一个实施例的透视图。
现在将详细描述本发明的优选实施例，实施例的例子将通过附图进行阐述。
具体实施方式
在以下的描述中，在全部的附图中，相似的参考符号表示相似或相应的零件。同时在以下描述中，应当这样理解，术语如前、后、里面、外面以及类似的词语是简易词语，不应当被解释为限制术语。本发明中用到的术语并不意味着限制在这里所描述的装置的范围内，或部分范围内，它可以附加或使用在其他方面。参照附图的更多细节，现在将描述本发明。
参照图1，可调节胃带10所示环绕在胃12的上部，通过将两端固定在一起以及延伸胃12的一部分14通过将该部分14缝合在胃上覆盖在可调整胃带10上方来保持在适当的位置上。同样参照图2，该可调节胃带10包括一个不可延展的带16和一个可充气的气球18，其可以由医用级硅酮聚合体或其他任何适合的材料制成，并且被带16的内表面20携带。气球18可以以任何公知的方式牢固于内表面20上，或甚至可以与带16成为一体，尽管带16通常是用不同的材料制成。
弹性导管22的一端与气球18的内腔24流体连接，其另一端与远端注射口26的内腔(未示出)流体连接。该远端注射口26包括一个硅酮隔膜28。当可调节胃带10被移植到胃某一部分的周围时，远端注射口26也被移植到一个对于经由Huber针的经皮下入口合适的位置，通常是在直肌的鞘里。
总所周知，内腔24、弹性导管22和远端注射口26的内腔优选至少部分地装填生理上相容的流体，如含盐的溶液。外科手术后用气球18对环绕周长的调节及因此得到的气孔尺寸是通过经由皮肤注射Huber针进入注射端口18的硅树脂隔膜28的方法从气球18的内腔24中添加或移开的流体来完成的。
本领域公知的可调节胃带10可以用任何适合的医学上兼容的材料来制作，该材料具有足够的强度以满足外科手术中特殊的腹腔镜检和特殊的病人的需要。
如上所述，可调节胃带10的两端被连接在一起(图1中未示出详细的固定机构的结构)。本发明的注意力集中在用于将两端连接在一起的反向内表面固定机构的各种实施例上。如图1和2所示可调节胃带10的大体结构和以上描述为图3至10中所述实施例所共有，这些实施例通过特殊的固定机构相区别。应当注意，本发明的实践可以使用任何带，并且不仅限于使用具有上述或下述原样特征的可调节胃带。
现在参看图3，该可调节胃带30包括一个伸长的带32，即使当植入的可调节胃带30具有弓形轮廓，该带32仍沿以在此提到的纵向方向延伸。带32包括一个内表面34和一个外表面36，气球38从邻近的内表面34向内延伸。可调节胃带30包括一个毗邻第二端部分42的第一端部分40，处于第一端部分40的可调节胃带30的内表面34被放置在靠近处于第二端部分42的可调节胃带30的内表面34。
参看图4，该图图解了图3中可调节胃带的反向内表面固定机构，该第一端部分40包括一个横向延伸元件46，该横向延伸元件46从内表面34总体上垂直地延伸。该元件46具有接合第二端部分42的外形。更特殊的，该横向延伸元件46界定出一个与处于第一端部分40的内表面3连接的通道48，该第一端部分40具有接收于第二端部分42的外形。元件46包括两个间隔放置的腿50、52，其从处于带32的对边54、56的内表面34延伸，一个交叉元件58在它们之间延伸。
第二端42包括一个从它的外表面延伸出来的保持元件60。该保持元件60包括一们顷斜表面62，其可以如显示的那样呈弓形，或是平的。该保持元件60还包括保持力表面64，其从外表面36总体上垂直地延伸，并垂直于第一和第二端部分40、42之间的任何相对运动。该保持力表面64必须在通道48的上边缘上方延伸一端足够的距离，以提供防止脱离所设定的力。在描述的实施例中，保持力表面64向远离交叉元件58的顶端延伸。
现在参看图5A-C，这显示了第一和第二端40、42接合的不同阶段的系列放大局部横截面侧视图。与图4相似，图5A图解了相互毗邻的第一和第二端部分40、42，其各自的内表面34相邻布置，并相互接触。
在图5B中，第二端部分42已经被向通过横向延伸元件46被容纳的第二端部分42的接合推进了，该保持元件60放置于通道48内。如图所示，该保持元件60被压缩，通道48的高度由横向延伸元件46的伸长而充分膨胀，以允许第二端部分42和保持元件60通道48被插入。该横向延伸元件46，保持元件60和横向延伸元件46具有充足的弹性以允许这种交互作用。交叉元件58包括一个导入端表面66以帮助第二端部分42进入通道48的插入和保持元件60的通路。
图5C图解了与第二端部分42啮合时的横向延伸元件46，保持元件60的保持力表面64靠近表面70，以防止第二端部分42产生不希望的退回，这会使第二端部分42从第一端部分40脱离。当需要移开可调节胃带时，脱离这两个端部分40、42所需要的力足够低以至于可以被克服。
图6和7显示了可调节胃带90的另一个实施例，这种可调节胃带90具有反向内表面固定机构的另一种结构。第一端部分92毗邻第二端部分94。尽管第一端部分92被图解为与带96呈90°角，关于这个实施例第一端部分92的表面98被认为是内表面102的延续。同样，第二端部分94的表面102是内表面100的延续。
第一端部分92包括一个从表面98总体上垂直地延伸的横向延伸元件104。该元件104具有连接第二端部分94的外形。横向延伸元件104界定一个与处于第一端部分92的表面98连接的通道106，该第一端部分92具有容纳第二端部分94的外形。元件104包括两个间隔放置的腿108、110，其从处于对边112、114的表面98延伸，交叉元件116在它们之间延伸。多个间隔放置的突出部分118从第一端部分92的远端120延伸。基于成形的考虑，一个后角部分122在第一端部分92的外部成形。
第二端点94包括一个具有箭头形末端126的保持元件124。正如图6和7中所示，箭头有一个狭窄尖端128和一个宽基底130。末端126被设置在从第二端部分94的基底部分134总体上垂直地延伸的塑料轴132的一端，具有横向面136。
为了将两个端部分92、94连接在一起，末端126如箭头部分138所示旋转，以使箭头的基底130总体上与通道106连接。由于末端126的尺寸与通道106的尺寸互补，所以末端126可以容易地通过该通道。末端126穿过通道106被插入，并被拉出，这样基底130完全通过末端120，拉长轴132。筋条突起140可以允许末端126更容易抓紧。
一旦拉过通道106，末端126被旋转回其标准方向，沿纵向方向延伸而不与通道106呈一直线。基底130被定位于突起118之间，塑料轴132促使基底130靠着末端120。因而，如在图7中所示，末端126趋向保持其标准方向。
图8和9图解了反向内表面固定机构的另一个实施例。可调节胃带142包括被拉长的带144，其包括一个内表面146和一个外表面148。带142包括一个第一端部分150和一个第二端部分152。当带142被植入环绕胃时，第一端部分150的内表面146毗邻第二端部分的内表面146。
内表面146依靠反向内表面固定机构互相固定。第一端部分150包括一个从内表面146总体上垂直地延伸的横向延伸的元件154，其具有连接第二端部分152的外形。横向延伸元件154界定一个通道156，并包括两个间隔放置的竖立的腿158和160，一个交叉元件162从它们之间延伸。
元件154包括一个从交叉元件154、远离第一端部分的末端150a处延伸的阻力板162。该短小突出部162包括多个筋条164，其提供了用于抓紧阻力板162的更好把手以提供反向力，然后通过通道156推动第二端部分152的末端152a。
第二端部分152包括一个从外表面148延伸的保持元件166。保持元件166包括一个在顶部和侧面倾斜的导向面168，以允许当两端被固定在一起时保持元件166相对容易地穿过通道156。保持元件166包括从这里向外延伸的保持力表面170。
第二端部分152包括一个与保持元件166相邻的颈部172。颈部170的基底172包括斜面174，当连接在一起时，该斜面174啮合位于元件154相应侧面上的形状互补且定向的表面176。该斜面174从基底172引出，以减少颈部172的横向宽度。颈部的高度和宽度对应于通道156的尺寸，并且可以从带144的剩下部分偏移。
保持表面170从保持原件166延伸，此处，颈部172连接保持原件166。保持表面170远离通道156各边延伸，以啮合横向元件154的相应表面176。如示，保持表面170可以远离末端152a倾斜，表面176与该保持表面170互补。
末端152a呈锥形，在保持元件166前方延伸，并且包括多个筋条178，其提高了末端152a的抓紧能力。一个表面构造180，所示为凹进的菱形形状，可以包括保持元件166合适位置的可视指示器，当两端被固定时，远离通道156延伸，以使得表面170和176相互毗邻。
穿过通道156退回第二端部分152以将其从第一端部分150分离出来的能力可以受到保持原件166中形成的后角或腔的包含物帮助，例如，一个圆形的或菱形的横向延伸腔可以正好在或在表面构造180附近形成，而不用作用于第二端部分152的保持力。挤压邻近如后角或内腔的保持力元件166，回复力将使得保持力元件166横向压缩，以更容易通过通道156回撤。弹性元件，起到弹簧的作用，也可以被成型安装在这样一个内腔附近。
对本领域技术人员来说显而易见的是，上述发明对于其他类型的可植入带具有同等的适应性。例如，带用于粪便排泄失禁的治疗。这样的带在专利US6461292了描述，该专利作为参考并合并与此。带也可以治疗小便的失禁。这样的带在美国专利申请2003/0105385中得到了描述，该专利作为参考并合并与此。带也可以用来治疗胃灼热和/或酸回流。这样的带在专利US6470892得到了描述，该专利作为参考并合并与此。带也可以用来治疗阳痿。这样的带在美国专利申请2003/0114729得到了描述，该专利作为参考并合并与此。
因此，与在这里和在权利要求中的应用一样，可植入带是一个可以移植到一个位置以闭塞流动的的带，该流动如穿过一个解剖通道，如胃或内腔的食物流或体流。
总之，已经描述了使用了本发明的概念产生众多优点。本发明一个或多个实施例在前描述已经为了阐述和说明本发明进行了介绍，但并非意味着穷举和限制本发明的目的。根据以上教导显而易见的修改和变化是可能的。一个或多个实施例被选出来进行和描述，目的是更好的解释本发明的原理和使用以使得本领域普通技术人员在各种各样的实施例和修改中如适合预期的特殊用途中最好地使用本发明。本发明的范围通过在此提出的权利要求设定。

Claims (10)

1.一种用于医疗的可植入带，该带包括
(a)被成型以围绕解剖通道一部分的带，所述带有一个内表面和外表面；
(b)分别设置在所述带的端部的第一和第二端部分，所述第一和第二端部分可以连接起来，从而紧固与解剖通道相邻的所述带，当所述第一和第二端部分连接在一起时，所述第一和第二端部分向外延伸；和
(c)至少一个从所述第一端部分延伸的横向延伸元件，所述至少一个横向延伸元件被成型以啮合所述第二端部分，并借此将所述第一和第二端部分固定在一起。
2.根据权利要求1所述的带，其中所述至少一个横向延伸元件界定一通道，所述第二端部分被成型设置为通过所述通道延伸。
3.根据权利要求2所述的带，其中所述第二端部分包含一保持元件，当所述第二端部分通过所述通道延伸时，该保持元件被成型设置为与所述至少一个横向延伸元件结合，以防止所述第二端部分从所述通道中退回。
4.根据权利要求1所述的带，其中所述第一和第二端部分包括各自的内表面和外表面，其对应于所述带的所述内表面和外表面，并且当固定在一起时，其中所述第一和第二端部分的所述的内表面相互毗邻。
5.根据权利要求1所述的带，其中所述第一和第二端部分包括各自的内表面和外表面，其对应于所述带的所述内表面和外表面，并且当固定在一起时，其中所述第一和第二端部分的所述的外表面相互毗邻。
6.根据权利要求1所述的带，其中所述至少一个横向延伸元件包括一末端，其中所述第二端部分被成型设置为接收和保持所述至少一个横向延伸元件。
7.根据权利要求6所述的带，其中所述至少一个横向延伸元件的所述末端包括一个扩大部，其中所述第二端部分包括至少一个比所述扩大部小的开口。
8.根据权利要求7所述的带，其中第二端包括多个间隔放置的层，所述至少一个开口包括通过所述每层形成的各自开口，所述开口相互排成一行。
9.根据权利要求3所述的带，其中所述通道具有宽度和高度，其中所述保持元件包括一尖端和一基底，所述基底比所述通道的高度宽。
10.根据权利要求9所述的带，其中所述保持元件为箭头状。
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