CN1618411A - 带有非机械连接机构的可植入束带 - Google Patents
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Abstract
一种可植入的束带，可围绕解剖学上的通道设置，比如胃和其他管腔，可作为可调节的胃束带，其具有非机械的连接机构，包括钩环连接件、磁性材料、粘结剂和能量连接材料。
Description
相关申请
本申请要求享有2003年6月27提出的临时专利申请No.60/483,353的优先权，本文参考引用其内容。本申请还参考引用了下列共同未决的同日提出申请的美国专利，即申请号为No.60/483,353的临时专利申请(题目为：带有改进的连接机构的可植入束带，发明人为Byrum，Jambor和Albrecht)；申请号为10/677,088的专利(题目为：带有横向连接机构的可植入束带，发明人为Byrum，Jambor和Crawford)；临时专利申请No.60/483,353(题目为：带有连接机构的可植入束带，发明人为Byrum，Jambor，Conlon，Crawford，Harper，Spreckelmeier)；以及临时专利申请No.60/507,612(题目为：带有可变形的连接机构的可植入束带，发明人为Byrum，Wiley，Conlon，Fender)。
技术领域
本发明总体上涉及一种可手术植入的围绕解剖学上的通道的束带，具体涉及到控制肥胖症的围绕胃的可调节胃束带，本发明公开了一种可调节胃束带的改进的连接机构。
背景技术
从20世纪80年代早期，就已经应用胃束带来有效地替代病态肥胖症的胃旁路和其他不可逆转的手术减体重治疗。胃束带围绕患者胃的上部，形成小于胃的正常内部直径的通道，限制食物通过胃的上部到达胃的下消化部分。当通道具有适当尺寸时，保留在胃上部的食物可提供饱满的感觉，不鼓励过度饮食。
胃束带能够锁定位置以设定胃束带的外径，胃束带的可调节性通过可向内充入流体的气囊来实现，类似于血压计套，通过流体注入口注入气囊中的是如盐水这样的流体，以得到希望的直径。当气囊初始置于体内围绕新的束带位置进行体内调整和治疗时，气囊一般是瘪的或部分是膨胀的。由于可调节的胃束带长时间保留在病人身体内，流体注入口一般置于皮下以防止感染，例如位于胸骨的前面。在初步植入之后，手术医生可根据病人的需要放松和束紧束带进行调整。可调节的胃束带中的流体量进行调节则是插入Huber针头通过皮肤进入注射口的硅胶隔膜来实现。一旦拔出针头，隔膜产生的压载荷使隔膜密封住孔。柔性导管连通注射口和可调节的胃束带。
可调节胃束带的连接机构必须提供胃的通道的初步尺寸。一种已知的常用连接方式是缝合可调节胃束带的端部。另一种已知的连接方式包括胃束带的一端部端接柔性导管，柔性管具有扩口部分，可从胃束带的第二端的开口抽出再缝合到环绕的带部分，以将束带固定到胃。缝合到位后，将注射口固定到方便的位置。
尽管这些已知的方法对于固定胃束带是有效的，仍希望能进行进一步的改进，以简化手术植入过程，并具有长期可靠性，可方便地进行重新调整或取出。
尽管过去把缝合视作最正统的连接方式，但希望有不需进行缝合的固定方式，同时不需很大的力来进行固定连接。否则，用腹腔镜等仪器将难以得到满意的抓紧和连接。因此，对带有改进的连接机构的可调节胃束带存在很大需求。
发明内容
本发明解决了现有技术所存在的这些和其他问题，本发明提供了一种可调节胃束带，可通过很小的力来接合，因此有助于利用腹腔镜等仪器来实施，而且在长时间使用后连接仍可靠。
本发明的总体上的目的是提供一种可调节的胃束带，其具有非机械连接机构。
本发明的另一目的是提供一种容易反调节的胃束带，其可固定和在不减少连接机构的保持强度的情况下脱开固定。
本发明的另一目的是提供一种可调节的胃束带，其具有可靠的固定机构，可固定和在不减小连接机构的强度的情况下脱开固定。
为了实现上述和其他目的，根据本文所介绍的本发明的目的，提出了一种可调节的胃束带，其具有将两端连接到一起的非机械连接机构。非机械连接机构包括钩环连接机构、磁性连接机构、粘接连接机构和使用能量连接。
从下面的详细介绍、讨论和所附权利要求并结合附图，可对本发明的其他新特征和目的有清楚的了解。
附图说明
与本说明书结合并构成其中一部分的附图显示了本发明的许多实施例，与上面给出的本发明的一般介绍以及下面给出的实施例的详细介绍一起，说明了本发明的原理。
图1是显示缠绕在胃上部的可调节胃束带的示意图；
图2是图1所示的可调节胃束带的沿2-2剖面的透视图；
图3是根据本发明的可调节胃束带的顶视图，束带设有钩环连接机构；
图4是图3所示可调节胃束带的可选择实施例的顶视图；
图5是根据本发明的可调节胃束带的另一实施例的顶视图，其具有磁性连接机构；
图6是根据本发明的具有粘接连接机构的可调节胃束带的两个端部的部分放大透视图；
图7是根据本发明的可调节胃束带的两个端部的部分放大透视图，其中两个端部已经能量连接到一起；
现在详细参考本发明的优选实施例，其示例在附图显示。
具体实施方式
在下面的说明中，类似的标记在各附图中代表类似或对应的元件。另外，在下面的介绍中，应当懂得用语如前、后、内、外及类似用语是方便用词，不是限制性用词。本专利中的术语并不打算用于限制所介绍的装置，其结构部分可连接到或用于其他的位置。现在参考附图详细地对本发明进行介绍。
参考图1，可调节的胃束带10显示出围绕胃12的上部，通过连接两个端部到一起并通过将部分14缝合到胃使胃12的部分14在可调节的胃束带上延伸来定位到适当位置。参考图2，可调节的胃束带10包括不能延伸的带索16和可充入流体的气囊18，其用医学等级的硅胶聚合物或任何其他适合的材料制造，并由带索16的内表面20支承。气囊18可通过任何已知方式固定到内表面20，或者采用与带索16相同的结构材料，尽管带索16一般用不同的材料形成。
柔性导管22的一端与气囊18的内腔24流体连通，另一端流体连通到远处的注射口26的内部空腔(未显示)。远处的注射口26包括硅胶隔膜28。当可调节的胃束带10植入一部分胃的周围，远处的注射口26也植入适当的位置，通常位于直肌鞘，使用Huber针头经皮肤进行输入。
都已知道，内腔24、柔性导管22和远处的注射口26的内腔最好至少部分充填病理生理上相容的流体，比如盐水溶液。通过刺入Huber针头进到注射口18的硅胶隔膜28添加或从气囊的内腔24取出流体，可进行气囊18包围的周长和通道尺寸的术后调整。
所述领域的技术人员都知道，可调节的胃束带10可用任何适当的医学相容的材料制成，材料应具有足够的强度，以满足特定的腹腔镜手术或特定病人的要求。
如上所述，可调节的胃束带10的两个端部连接到一起(图1中未显示特定连接机构的结构)。本发明涉及可连接两端到一起的非机械连接机构的各种实施例。图1和图2中显示和上面介绍的可调节胃束带10的大致结构在图3到图7所显示的实施例中是通用的，各实施例不同之处在于特定的连接机构。应当注意到，本发明的实施可使用任何一种胃束带，并且不限于使用具有上面或下面介绍的具体特征的可调节胃束带。
再参考图3，可调节的胃束带30包括细长的带索32，沿本文中的纵向延伸，即使可调节的胃束带30植入后具有弧形形状。带索32包括内表面34和外表面36，气囊38从附近的内表面34向内延伸。可调节的胃束带30包括第一端部40，其重叠到第二端部42，可调节的胃束带30的内表面34在第一端部40设置成靠近第二端部42的可调节的胃束带30的外表面36。
第一和第二端部40、42通过非机械连接机构固定到一起。在所作介绍中，非机械连接机构是指通过肉眼不容易看出的连接机构。非机械连接机构包括磁性元件、粘结剂、材料焊接、钩环连接件以及类似连接件。现有技术的胃束带利用形成了干涉和连接的基于几何形状的特征件。在图3所示的实施例中，非机械连接机构是钩环连接件，支承于附近的第一和第二端部40、42的表面。端部40的内表面34支承用44表示的钩材料或环材料，而第二端部42的外表面36支承用46表示的对应配合材料，可以是环或钩材料。钩和环材料的固定特性是已知的，钩材料在非常小的微观水平上与环材料接合，单个钩和单个环之间不需要特别地对准，每平方英寸材料上的众多钩和环产生大量共担载荷，单个钩和环不支承全部载荷的很大部分。即使钩和环材料的操作涉及到钩部分围绕环延伸，这种连接机构在本文中仍被认为是非机械的。
钩环材料固定件44，46通过任何适当的方法，如生理学上相容的粘结剂，分别连接到第一和第二端部34、36的表面。钩和环材料44、46可以用任何医学相容的材料制造，如不锈钢。第一和第二端部40a、42a互相重叠一段长度，该长度至少应足以将所采用的特定非机械连接机构的两个端部保持在一起。所采用的示例中，图3所示的钩环非机械连接机构的重叠长度大约在2.5厘米。
钩和环固定件44、46可对调节胃束带的端部快速和容易地进行固定，在气囊18进行调节后，具有足够的保持处于适当位置的强度，但是当需要时手术医生可取出钩环固定件或进行调节。
图4显示了图3可调节胃束带实施例的其他可选择的实施例。可调节的胃束带30a包括钩环非机械连接机构，其支承于附近的第一和第二端部40a、42a的表面。在这个实施例中，可调节的胃束带30a的内表面34a在第二端部42a支承对应的结合材料，可以是环或是钩材料46a，与第一端部40a的可调节胃束带30a的内表面34a支承的钩或环材料44a接合。在这个实施例中，当第一和第二端部40a、42a固定到一起，各个端部的内表面34a互相相对。应当注意到，连接的第一和第二端部40a，42a可沿任何角度向外延伸，如沿图4中的径向，通常与可调节的胃束带30a包围的区域中心对齐。与这个可选择的实施例不同，第一或第二端部可通过在另一端部上形成的开口延伸，或围绕另一端部的边延伸，使端部的外表面互相相对，钩和环材料分别支承于相对的表面。
图5所示的实施例包括磁性非机械连接机构。可调节的胃束带48包括细长的带索50，其具有内表面52和外表面54，气囊56从相邻的内表面52向内延伸。可调节的胃束带48包括与第二端部60重叠的第一端部58，第一端部58的内表面52设置在第二端部60的外表面54的附近。
第一和第二端部58、60分别支承磁性材料62、64，其中至少一个是磁铁。如本文中所用的，磁性材料包括磁铁和任何可吸引到磁铁上的材料。磁性材料62、64可以是任何适当的医学相容的材料。当植入时，第一和第二端部58、60通过磁性材料之间的磁力保持在一起，选择、加工成适合尺寸和定位磁性材料以便其间产生足够的磁力，保持两个端部58、60在一起。
如图5所示，整个第一端部58是磁性材料62，通过适当的方式，如加热或压力粘接，粘结剂、或机械连接如缝合或钉合，固定到带索50。
第二部分60如图所示支承间隔开的磁性材料分离件64，比如磁性材料条，越过带索50第二端部60的宽度横向延伸。磁性材料件64可越过带索50的宽度延伸。磁性材料件64可以任何适当的方式连接到端部60。磁性材料件64可嵌入到适当位置被第二端部60完全包围，如同设置到其中形成的空腔，或模制。
可采用第一和第二端部58、60支承的磁性材料的任何结构。例如，两个端部58、60是磁性材料片。都设置一个或多个单个磁性材料插件。两个端部58、60上的磁性材料可以是一个或多个磁铁(但任何磁性材料的配对部分中至少一个必须是磁铁)，适当地定位和对准磁极。磁性材料可以任何适当的方式固定到或位于端部58、60。磁性材料可以是柔性的或是刚性的。
另外，端部58和60，磁性材料62、64可设置成交换结构，如同上面所讨论的钩环连接机构。例如，各端部的磁性材料可设置成端部的内表面互相临近，或端部的外表面互相临近。
图6显示的实施例包括粘接的非机械连接机构。图6是可调节的胃束带70的第一端部66和第二端部68的部分放大透视图。可调节的胃束带70的位于第一端部66的内表面72和可调节的胃束带70的位于第二端部68的内表面72中至少一个具有粘结剂，可固定两个端部66、68到一起。如图6所示，第一端部66的内表面72和第二端部68的内表面72分别具有粘结剂74、76。粘结剂74、76可以是任何能一旦接触快速固化的粘结剂，要能在体液中发挥作用，并具有足够的强度，包括粘接、冲击和拉伸强度；并具有足够的延展性，以将两个端部66、68固定到一起，并允许医生在需要时可分开。这种粘结剂包括如硅胶基粘结剂，粘结剂74可以与粘结剂76不同，但必须共同作用，当互相接触时进行固化。如果，粘结剂只设置在一个端部，粘结剂必须当与另一端部接触时能进行固化和粘接。
在进行植入之前，需要对粘结剂进行活化。这可以通过化学方式来实现，或通过清除保护性材料来实现，这种材料覆盖粘结剂74、76，使其不与外部材料接触，防止意外接触。
可调节的胃束带70不限于图6所示的结构。对于前面介绍的实施例，可调节的胃束带70可有另外的结构，如使端部66、68沿纵向重叠，或端部66、68的外表面78设置成互相相对，互相临近。
图7所示的实施例包括可调节的胃束带80，其具有非机械连接机构，可实现第一端部82与第二端部84的能量连接。使用各种已知的能量连接技术，可调节的胃束带80的第一端部82的内表面86牢固地连接到可调节胃束带80的第二端部84的内表面86，能量连接技术包括硅胶能量连接。一种专门为能量焊接设计的手术器械，比如抓紧器(未显示)，被手术医生用来将两个端部82、84夹到一起，然后施加所需的振动连接能，如现有技术已知的。本发明采用但不限于常用的能量连接，如高频焊接、超声波焊接，谐波焊接和类似方法。
通过本发明所公开的内容，所述领域的技术人员将认识到其他适合的工具或连接工艺也可在实施图6和图7所示的实施例时使用，比如，熔化或加热连接。
对于所属领域的技术人员，很容易理解到上述发明可同样应用于其他类型的植入束带。例如，用于治疗大便失禁的束带。一种这样的束带可见美国专利4,461,292，其内容本文引用参考。束带还可以治疗小便失禁，一种这样的束带在美国专利申请2003/0105383中公开，本文引用参考其内容。束带还可以用于治疗胃灼热和/或酸性胃液回流。一种这样的束带在美国专利6,470,892公开，本文引用参考其内容。束带还可以用于治疗阳萎。一种这样的束带在美国专利申请2003/0114729中公开，本文引用参考其内容。
因此，如说明书和权利要求所显示的，可植入束带是一种可植入到适当位置阻挡流体，如食物或体液，通过解剖学上的通道，如胃或管腔的束带。
总之，已经介绍了本发明概念所具有的众多优点。介绍前面的本发明的一个或多个实施例的目的是进行说明和介绍。而不是用于排除其他可能或限制本发明于所介绍的具体形式。在了解上述内容后可进行明显的改进或变化。所选择和介绍的一个或多个实施例是为了更好地说明本发明的原理和其实际应用，使得所属领域的技术人员更好地利用本发明的各种实施例和各种改进，以便使其适合于所考虑的具体应用。本发明的范围由所附权利要求限定。
Claims (10)
1.一种可植入的束带，用于医学症状的处理，所述束带包括：
(a)带索，可围绕解剖学上的通道设置，所述带索有内和外表面；
(b)第一和第二端部，设置在所述带索的两端，所述第一和第二端部设置成可互相连接，以将所述带索围绕所述解剖学上的通道固定，所述第一和第二端部分别包括内和外表面，对应于所述带索的内和外表面；
(c)所述第一或第二端部中至少一个包括非机械连接机构，所述第一端部可连接到所述第二端部，以固定所述带索到所述解剖学上的通道附近。
2.根据权利要求1所述的束带，其特征在于，所述第一端部设置了钩或环材料，所述第二端部设置了所述钩或环材料中的另一个。
3.根据权利要求1所述的束带，其特征在于，所述第一端部的内表面设置了钩或环材料，所述第二端部的外表面设置了所述钩或环材料中的另一个。
4.根据权利要求1所述的束带，其特征在于，所述第一端部的内表面设置了钩或环材料，所述第二端部的内表面设置了所述钩或环材料中的另一个。
5.根据权利要求1所述的束带，其特征在于，所述非机械连接机构包括磁性材料。
6.根据权利要求5所述的束带，其特征在于，所述第一和第二端部包括所述磁性材料。
7.根据权利要求6所述的束带，其特征在于，所述第一和第二端部中至少一个包括磁铁。
8.根据权利要求5所述的束带，其特征在于，所述第一和第二端部中至少一个包括嵌入其中的磁性材料。
9.根据权利要求1所述的束带，其特征在于，所述非机械连接机构包括粘结剂。
10.根据权利要求1所述的束带，其特征在于，所述第一端部的所述内和外表面中的一个设置了第一粘结剂，所述第二端部的所述内和外表面中的一个设置了第二粘结剂，因此，所述第一和第二粘结剂接触时互相粘接。
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- 2004-06-28 MX MXPA04006393A patent/MXPA04006393A/es unknown
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| CN103417254A (zh) * | 2012-05-21 | 2013-12-04 | 黄致锟 | 胃减容术的胃束带 |
| US10159699B2 (en) | 2013-01-15 | 2018-12-25 | Metamodix, Inc. | System and method for affecting intestinal microbial flora |
| US11793839B2 (en) | 2013-01-15 | 2023-10-24 | Metamodix, Inc. | System and method for affecting intestinal microbial flora |
| US9622897B1 (en) | 2016-03-03 | 2017-04-18 | Metamodix, Inc. | Pyloric anchors and methods for intestinal bypass sleeves |
| US20170252195A1 (en) | 2016-03-03 | 2017-09-07 | Metamodix, Inc. | Pyloric anchors and methods for intestinal bypass sleeves |
| US10729573B2 (en) | 2016-03-03 | 2020-08-04 | Metamodix, Inc. | Pyloric anchors and methods for intestinal bypass sleeves |
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| US11666470B2 (en) | 2016-05-19 | 2023-06-06 | Metamodix, Inc | Pyloric anchor retrieval tools and methods |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2005013744A (ja) | 2005-01-20 |
| CA2472655A1 (en) | 2004-12-27 |
| AU2011200302A9 (en) | 2011-03-10 |
| EP1491167A1 (en) | 2004-12-29 |
| BRPI0402532A (pt) | 2005-03-15 |
| AU2011200302A1 (en) | 2011-02-24 |
| CA2472655C (en) | 2012-10-23 |
| MXPA04006393A (es) | 2005-03-31 |
| US20040267291A1 (en) | 2004-12-30 |
| AU2004202488A1 (en) | 2005-01-20 |
| AU2011200302B2 (en) | 2012-03-15 |
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