CN1611197A - 具有横向连接机构的可植入式带子 - Google Patents

具有横向连接机构的可植入式带子 Download PDF

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CN1611197A
CN1611197A CN200410087487.8A CN200410087487A CN1611197A CN 1611197 A CN1611197 A CN 1611197A CN 200410087487 A CN200410087487 A CN 200410087487A CN 1611197 A CN1611197 A CN 1611197A
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CN100594852C (zh
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R·T·拜伦
K·L·杨博尔
N·克劳福德
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Ethicon Endo Surgery Inc
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Abstract

一种用于放置在如胃或其他管腔的组织通道周围的可植入带子，包括一个横向连接机构，如一个燕尾接头连接或以螺旋路径布置的一个横向部件。

Description

具有横向连接机构的可植入式带子
相关申请
本申请要求申请日为2003年6月27日，系列号为60/483,353的美国临时专利申请的优先权，其公开的内容在此均有提及。本申请也参考申请日相同的共同待审的美国专利申请：临时申请系列号为60/507,625(具有改进连接机构的可植入带子，发明人：Byrum，Jambor，Albrecht)；申请系列号10/676,368(具有非机械锁扣机构的可植入式带子，发明人：Byrum，Nuchols)；临时申请系列号为60/507,914(具有连接机构的可植入带子，发明人：Byrum，Jambor，Conlon，Crawford，Harper，Spreckelmeier)；临时申请系列号为60/507,612(具有可变形的连接机构的可植入带子，发明人：Byrum，Willy，Conlon，Fender)。
技术领域
本发明主要涉及一种用于环绕组织通道的外科可植入式带子，尤其是针对一种环绕胃以控制肥胖症的可调式束胃带。本发明将会清楚地公开关于可调式束胃带的改进的连接机构。
背景技术
从二十世纪八十年代早期，可调式束胃带就已经为病态肥胖的胃分流术和其他不可逆的外科减肥治疗提供了一种有效的选择。束胃带环绕在患者胃的上部分，形成了一个人造口，该人造口要比胃的通常内部直径要小，这就限制了食物从胃的上部进入到更低的消化部分。当该人造口的尺寸合适时，滞留在胃的上部分的食物提供了一种发胀的感觉，这就阻止了过度饱食。
除了用锁定位置设定束胃带直径外，束胃带的可调节性通常通过一个内部定向的可膨胀气球来实现，与血压袖带相似，其内部的流体，例如盐水，通过一个流体注入口注入以获得一个预期的直径。当先被置于身体内以允许身体调节和在新的带子周围愈合时，该气球显著地收缩或仅部分膨胀。由于可调式束胃带可以在病人体内保留很长一段时间，该流体注入部分被特定地皮下安装以避免感染，例如在腹板前面。在开始植入后，外科医生可以根据病人的需要通过松开或束紧来调节带子。可调式束胃带内部流体量的调节通过插入一个胡伯尖针(Huber tip needle)，穿过皮肤，进入到注入部分的硅酮隔膜来实现的。一旦尖针移开，隔膜利用其产生的压缩载荷的优点来封闭洞口。一个柔韧的导管连通注入部件和可调式束胃带。
用于可调式束胃带的连接机构必须提供胃的人造口的初始尺寸。一个普遍公知的连接是将可调式束胃带的末端缝合。另一个普遍公知的连接包括端接一根柔管的束胃带的一个末端，该柔管有一个喇叭状的部分，该部分被拉出，穿过束胃带另一端的一个开口，然后缝合到环形带子部分-将带子固定到胃上。缝合到适当位置后，在方便的位置锚定注入部分。
虽然这些已知的方法在固定束胃带方面是有效的，但是还需要进一步的改进以简化临床植入的程序，提供长时期的可靠性，方便重新调整或移动。
虽然在过去依靠缝合作为最积极的连接方式，但还是需要一个安全不需要缝合的连接，也不需要用很大的力来形成安全连接。另外，充分夹紧和与腹镜设备实现连接可能是困难的。因此，非常需要一个具有改进连接机构的可调式束胃带。
发明内容
本发明提出了现有技术中存在的这些和其他的问题，通过提供一种用较小的力啮合的可调式束胃带装置，方便了腹镜装置的实施，又保证该连接的长期使用。
本发明总的目的是提供一种具有横向连接机构的可调式束胃带。
本发明的另一个目的是提供一种容易可逆调节束胃带，它可以不用减少连接机构的夹紧力而实现夹紧和松开。
本发明的又一个目的是提供一种松开其末端所需要的力是额定的可调式束胃带，并且该额定力与轴向夹持力不在同一个方向，这样就不会将两个末端分开。
为了实现上述以及其他的目的，并与此处描述的本发明的目的一致，描述了将两个末端连接在一起的具有横向连接机构的可调式束胃带。该横向连接机构包括一个燕尾接头，和一个有迂回路径的钩子。
结合下面的详细的描述，讨论和所附的权利要求以及相关附图，本发明的更多新的特性和其他目的将会很明显。
附图说明
本说明书的的附图可以解释本发明的实施例，以上本发明的概括描述，和下面给出的实施例的具体描述一起，用来解释本发明的原理。
图1为环绕胃的上部分的可调式束胃带的简图。
图2为图l中所示可调式束胃带沿线2-2的横断面视图。
图3为具有燕尾接头的横向连接机构的可调式束胃带的透视图。
图4为如图3中所示的可调式束胃带的顶视图。
图5为具有突出的燕尾接头的横向连接机构(显示未连接)的可调式束胃带的透视图。
图6为图5中所示的可调式束胃带，带有突出的燕尾接头的横向连接机构的两个末端连接在一起时的侧视图。
图7为如图6中所示的可调式束胃带的顶视图。
图8为具有一个钩子的横向连接机构(未连接时的)的可调式束胃带的透视图。
图9为如图8中所示的可调式束胃带，带有钩子的横向连接机构的连接在一起时的透视图。
图10A-D为沿图9中面10-10的横断面的一系列侧视图，解释钩子的末端与扣的连接。
图11描述了图8中挂钩的另一个实施例。
本发明的当前优选实施例将被详述，其中的例子在所附的附图中得到解释。
具体实施方式
在下面的描述中，贯串几个附图的相同参考标记指示相同或相关部分。同样，在下面的描述中，可以理解，例如前面，后面，内部，外部等词语是便于使用的词语，并且不应该被解释为限定性的词语。本发明中所使用的术语不意味着限制在此处所描述的装置的范围，或者其中的部分可以被附加或应用到其他方面。详细参考附图，本发明将得到描述。
参照图1，一个可调式束胃带10环绕在胃12的上部分，通过将两端连接在一起，并且通过将部分14缝合到胃上在束胃带10上延伸胃12的一个部分14。并且参考图2，可调式束胃带l0包括一个不可延伸的带子16和一个可膨胀的气球18，由医用硅酮聚合物或任何其他适合的材料制成，被带子16的内表面20携带。气球18可以以任何已知的方式被固定在内表面20上，甚至可以与带子16做成一体的结构，尽管带子16可以典型地由不同的材料形成。
一根柔管22的一端与气球的内腔24流体连通，另一端与远端注入部分26的内腔(未示出)流体连通。远端注入部分26包括一个硅酮隔膜28。当可调式束胃带10环绕胃的一部分被植入时，远端注入部分26也在一个适合的位置植入，通常在直肌鞘(rectus sheaths)内，以借助胡伯针(Huber needle)经皮进入。
众所周知，内腔24，柔管22和远端注入部分26的内腔最好至少部分充入生理兼容的流体，例如盐水溶液。被气球18封闭的周边以及人造口的尺寸的调整，借助胡伯针从皮下进入到注入部分18的硅酮隔膜28，从气球18的内腔24加入或排除液体来实现。
如本领域所熟知的，可调式束胃带可以由任何合适的生理兼容的材料制成，该材料对特别的腹镜手术或特殊的病人应有足够的强度。
如上面所提到的，可调式束胃带的两端被连接在一起(图1中没有说明该特殊连接机构的结构)。当前发明针对用于连接两端的横向连接机构的不同实施例。图1和图2及中示出的及上面所描述的可调式束胃带的一般结构与图3-11中所说明的一致，区别在于实施例的不同连接机构。应该注意本发明的实践可以使用任何的带子，不限于使用具有上面或下面描述的确切特性的可调式束胃带。
转向图3和4，可调式束胃带30包括一根在此处所涉及的轴向延伸的细长带子32，尽管当植入时可调式束胃具有弓形构型。带子32包括一个内表面34和一个外表面36，带有从靠近内表面34向内延伸的气球38。可调式束胃带30包括一个第一末端部分40，其搭接第二末端部分42，可调式束胃带的内表面34被设置成在第一末端部分40处临近、在第二末端部分42处位于可调式束胃带30的外表面36的外面。
第一和第二末端部分40，42通过一个燕尾接头横向连接机构被固定在一起。一个基本梯形部件44，它是燕尾接头连接的销部分，相对纵轴横向导向，在第一末端部分40从内表面34延伸。该部件44有3个梯形侧面，相对侧面46，48向彼此倾斜。一个形状互补的横向槽50，是燕尾接头连接的尾端，在第二末端部分42处在外表面36上形成，其成形以接受部件44。
横向连接机构包括一个制动器52，其相对于槽50固定部件44，阻止它们之间的横向移动，并关于连接对外科医生提供正反馈。制动器52通过一个从部件44的低端延伸的凸块54和一个在槽50的底部形状互补的凹座56形成。
可以理解，燕尾形部件44和槽50的位置可以转换，部件44可以在第二末端部分42的外表面36形成，槽50可以在第一末端部分40的内表面34形成。凸块54和凹座56的位置也可以互换。另外，本领域的技术人员将会认识到梯形横断面是说明性的，部件44，槽50和制动器52还可以使用很多几何形状和数量。
将可调式束胃带30环绕在胃上后，为了将两个端部连接，部件44滑入槽50中，仅需要一个额定力来克服制动器52。因为在连接的第一和第二末端部分40，42之间的相对移动被限制在横向，直到松开，因此，作用在可调式束胃带上的任何纵向和径向(向外的)力不会将末端40，42分开(除了破损或变形)。为了将末端部分40，42分开，仅需要一个额定的横向力以在它们之间产生一个横向运动，该力大于当可调式束胃带被植入时燕尾接头横向连接机构通常承受的横向力的力。一旦末端部分40，42被分开，它们可以纵向移动。
尽管部件44和槽50被描述成梯形，任何一旦啮合就能阻止第一和第二末端部分纵向或径向移动的形状都可以使用，但其提供的横向移动作为基本上相对移动的唯一方向并且提供的力允许两个末端40，42分开。
由于槽50的纵向宽度比部件44的一部分的纵向宽度窄，这样部件44和槽50的基本梯形结构造成的末端部分40，42之间的径向(向外)移动就可被防止。由于部件44和槽50的横向表面是基本垂直于纵向载荷方向(夹持力)，该载荷不会导致相对横向运动。因此，由于纵向力(夹持力或分离力)和唯一的横向力之间的正交关系，将可调式束胃带末端分离的运动将纵向力从脱离力中分离。
图5中说明了一个燕尾接头横向连接机构的另一个实施例。可调式束胃带60的第一末端部分58包括一个U型组成部件62，其从可调式束胃带60的外表面64延伸。该U型部件62包括一个向外延伸的底板66，其在末端支持一个横向延伸的部件68，该部件与外表面62间隔并与之平行，这形成了燕尾接头连接的销部分。
如所示的，部件68有一个梯形形状。有一个互补形状的横向槽72，在第二末端部分70处在可调式束胃带60的外表面62上形成，其成形以接受部件68。
一个锁紧件74在第一末端部分58处从外表面62延伸，横向与部件68和外表面62之间的间隙结合。同样参考图6和7，锁紧件74包括开始于第一末端部分58的上部边缘并在锁紧件74的下表面终止的倾斜表面76。如图6和7中所示，下表面80以上被隔开，但没有压在上面，部件68的末端82留下一个间隙84。结合可调式束胃带的柔韧性，间隙84的尺寸被确定以允许第二末端部分70插入，在作为斜面的倾斜表面76的引导下，部件68可以设置在槽72中，第二末端部分70在第一末端部分58延伸穿过部件68和外表面62之间的空间。
第二末端部分70的横向宽度小于底板66与下表面80之间的横向间隔。下表面80从外表面62基本垂直地延伸，当连接时垂直于第一和第二末端部分58，70之间的任何相对运动，抵抗横向力以便保持第二末端部分70在适当位置。因为直到它们分开为止，第一和第二末端部分58，70之间的相对运动都在限制在横向上，作用在可调式束胃带60上的纵向或径向的力不会将它们分开。
参考图8和9，这里合乎透视法地说明了一种具有钩子横向连接机构的可调式束胃带(未连接)。该可调式束胃带88包括一个第一末端部分90，其终止于一个螺旋挂钩92，该挂钩限定了一个大约1-2mm的螺旋形间隙94。该螺旋形挂钩92可由金属，硬塑料，或其他适合的材料制成，并且以任何适当的方式附在可调式束胃带88上，例如用硅酮粘合等。挂钩92的构型和材料可以提供象弹簧一样的性质，拥有所希望的治疗和性能的好处。
可调式束胃带88的第二末端部分96在带扣98终止，有一个穿过间隙102延伸的锁紧棒100，该间隙由相互间隔平行的翼104，106限定。
第一和第二末端部分连接的过程在图10A-D说明的系列位置中得到描述。挂钩94开始时在间隙102下方。在图10A中，螺旋挂钩94放置在间隙102中，在入口108处有锁紧棒100，在第一末端部分90的狭窄开口通向螺旋间隙94。锁紧棒100通过相对于第二末端部分96横向和纵向移动第一末端部分90沿着螺旋间隙94的路径前进，到达图10B所示的位置。第一末端部分90相对于第二末端部分96的进一步横向和纵向的运动进一步沿着螺旋间隙94放置锁紧棒100的位置，到图10C中所示的位置，最后到达图10D中所示的最终位置。
在图10D的完全连接位置中，纵向力不会引起已连接的第一和第二末端部分90，94分离。分离需要两个末端部分90，94之间的横向和纵向的相对运动协同。尽管所示为螺旋路径，但可以使用任何需要横向和纵向运动方向协同的环形路径，以分离两个末端部分90，94。
图11说明了形成一个纵向可调横向连接机构的挂钩的另一个实施例。第一末端部分110终止于挂钩112，其限定了一个分叉的路径114。该分叉路径114允许选择锁紧棒110可被横向定位的适当的位置116，118。挂钩112终止于限定了位置116，118的间隔末端120，122。挂钩112的构型允许可调式束胃带的周线可以被设置成多于一个长度。
其他的间隔末端部分可以被插入以提供另外的位置。挂钩的末端被成型以轴向延伸，这样锁紧棒就不能仅被的横向力改变位置。
对于本领域的技术人员来说，以上的发明同样适用于其他类型的可植入式带子，这很明显。例如，用来治疗粪便失禁的带子。一种这样的带子在美国专利US6,461,292中被公开，其在这里作为参考。带子也可以用来治疗小便失禁。一种这样的带子在美国专利申请US2003/0105385中被公开，这里也作为参考。带子也可以用于治疗烧心和/或返酸。这样的一种带子在美国专利US6,470,892中被公开，这里也用作参考。带子还可以用来治疗阳痿。这样的一种带子在美国专利US2003/0114729中被公开，此处用作参考。
因此，如这里和权利要求中所用的，一种可植入式的带子是一种可以在一定位置植入以阻塞流动的带子，例如，通过一个组织通道如胃和管腔的食物和体液。
总之，已经描述了利用本发明的原理产生的很多好处。为了解释和说明，已经对本发明的一个或多个实施例进行了描述。这并不意味着本发明的无遗漏的描述或是将本发明限制在已公开的确切形式中。根据以上的教导可以作出显而易见的修改和改变。对一个或多个实施例进行选择和描述是为了更好地解释本发明的原理和应用，因此可以使本领域的普通技术人员以不同实施例和适合于特殊应用的多种修改形式更好地应用本发明。此处所附的权利要求确定本发明的保护范围。

Claims (10)

1.一种用于内科治疗的可植入式带子，该带子包括：
(a)一个用于环绕一个组织通道的成形的带子，所述带子在附近限定了一个环形方向，所述带子具有内表面和外表面；
(b)在所述细长带子的两个末端配置了第一和第二末端部分，所述第一和第二末端部分包括与所述带子的所述内表面和外表面相应的各自的内表面和外表面；
(c)一个成形的横向连接机构，将所述第一末端部分和所述第二末端部分连接，以保证所述带子紧靠组织通道。
2.如权利要求1所述的带子，其特征在于，所述横向连接机构包括一个形成所述第一末端部分的一部分的横向部件和一个形成所述第二末端部分的内表面和外表面的一部分的横向孔道，所述横向孔道被成形以容纳所述横向部件。
3.如权利要求2所述的带子，其特征在于，所述横向连接机构包括一个具有销部分和尾端部分的燕尾接头横向连接机构，所述横向部件包括所述销部分，所述横向孔道包括所述尾端部分。
4.如权利要求3所述的带子，其特征在于，所述横向部件具有一个基本梯形的形状，所述横向孔道包括一个梯形槽。
5.如权利要求4所述的带子，其特征在于，所述横向连接机构包括一个制动器，所述横向部件含有所述制动器的第一部分，所述横向孔道含有所述制动器的第二部分。
6.如权利要求3(或4)所述的带子，其特征在于，所述第一末端部分包括一个U形部分，所述U形部分包括一个从所述第一末端部分横向延伸的底板和从所述底板横向延伸的横向部件，由此形成了一个间隙。
7.如权利要求6所述的带子，其特征在于，当所述横向部件被配置在所述横向孔道时，所述第二末端部分被成形以穿过所述间隙。
8.如权利要求6所述的带子，其特征在于，包括一个从所述第一末端部分延伸覆盖所述间隙的制动件，所述制动件被成形以阻止所述第二末端部分从所述间隙中退出。
9.如权利要求8所述的带子，其特征在于，所述制动件包括一个与所述间隙基本垂直的下表面。
10.如权利要求2所述的带子，其特征在于，所述横向连接机构还包括一个制动器，所述横向部件包含所述制动器的第一部分，所述横向孔道包含所述制动器的第二部分。
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BRPI0404989A (pt) 2005-05-24
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