CN1429092A - 包括夹持片的胃成形术环 - Google Patents

包括夹持片的胃成形术环 Download PDF

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CN1429092A
CN1429092A CN01809361A CN01809361A CN1429092A CN 1429092 A CN1429092 A CN 1429092A CN 01809361 A CN01809361 A CN 01809361A CN 01809361 A CN01809361 A CN 01809361A CN 1429092 A CN1429092 A CN 1429092A
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holding piece
conduit
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萨洛蒙·邦谢特里
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Compagnie Europeenne dEtude et de Recherche de Dispositifs pour lImplantation par Laparoscopie SA
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/005—Gastric bands
    • A61F5/0066—Closing devices for gastric bands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/005—Gastric bands
    • A61F5/0053—Gastric bands remotely adjustable
    • A61F5/0056—Gastric bands remotely adjustable using injection ports

Abstract

本发明涉及一种胃成形术环，由一弹性带(2)形成，该弹性带包括第一端部(5)和第二端部(6)，并通过它的两端(5，6)的靠拢而闭合围绕胃部，该胃成形术环使用一个闭合系统通过形成环状来减小开口的直径，所述的带(2)包括一个环形的具有可变容积的压缩腔室(3)，该腔室(3)在所述第一端部(5)通过调节导管(7)与一装置连接，该装置用于调节所述腔室的内部压力，从而调节它的直径膨胀，所述胃成形术环包括至少一个夹持片(11，12，13)，该夹持片向环形的外侧突出，从而使得两个端部(5，6)可以更容易地闭合在一起和更容易地分开。该发明的胃植入物用于治疗肥胖症。

Description

包括夹持片的胃成形术环
技术领域
本发明涉及外科植入的技术领域，其用于通过植入弹性的胃约束带来约束病人的胃，从而治疗肥胖症，所述的胃约束带设有一具有可变容积的环形的压缩腔室，其通过一个与控制器连接的调节导管来调节，该控制装置被植入病人的体内。
本发明涉及一种由弹性带形成的胃成形术环，该弹性带包括第一端部和第二端部，并通过它的两端的靠拢而基本闭合围绕胃部，该胃成形术环使用一个闭合系统通过形成环状来减小开口(stoma)的直径，所述的带包括一个环形的具有可变容积的压缩腔室，该腔室在一个端部通过调节导管与一装置连接，该装置用于调节所述腔室的内部压力，从而调节它的直径膨胀。
背景技术
对于那些患有极端严重的肥胖症(病态肥胖症)的病人而言，也就是说，对于那些体重至少超过理想体重50公斤的病人而言，在这样的病人的身上进行外科手术是完全必要的，这不仅是为了避免由肥胖症引发的一系列的健康问题，还是为了避免这样的病人的必然和即将的死亡。
患有病态肥胖症的病人的预期寿命很明显地减少了十到三十年，同时还会引发一系列的心理上的负担，这一点已经被人们接受了。而且，还会有出现一系列相关的疾病的现象，特别是表现出心脏血管疾病，高血压，糖尿病和关节炎。
现在的治疗基于大量节食并结合一系列的身体锻炼，这些锻炼与行为的改变有关，特别是饮食行为，人们还观察到这样的治疗在这些病态肥胖症病人身上相对是没有效果的，尽管该治疗方法是最健康的。
这就是为什么病态肥胖症的长期治疗会用到外科治疗的原因。
一般来说，外科治疗技术可以分为两种，一种是使得食物被很少地吸收，如缩短食物和消化液通过的路径；另一种是使用胃约束，如减小胃的大小。
举例来说，依赖于少量吸收的外科技术，如使用绕道小肠的技术，或是把食物和消化液的通过的路径分开。旁路外科技术会引发严重的并发症，因此这样的技术现在已经很少使用了。将食物块通过的路径和消化液通过的路径分开的外科技术不会引发特别的并发症，虽然它需要大外科手术，但其意味着是部分胃切除术。
这就是为什么现在的趋势是采用利用胃约束法来减少食物摄入的外科技术的原因。
以常规的方式，胃成形术环围绕着胃被植入体内，用来减小胃的大小以及胃的通道(开口)的直径。
公知的大多数胃成形术装置，例如在美国专利US-A-5 074 868中公开的一种装置，利用由弹性材料制成的弹性带绕着胃部植入体内，然后通过一闭合系统被拉紧和闭合从而形成一个圈。弹性带体包括一可变容积的压缩空间或腔室，其通过一调节导管与一用于调节腔室内部压力的装置连接，从而改变环的内径，因此通过向腔室中注入一定的液体或从腔室中抽出一定的液体来改变和调节开口(stoma)的直径。调节环的内部直径的操作通过一个常规的控制装置来完成，该装置包括一个被直接植入病人皮肤之下的微型单元，该微型单元包括一个自密封的膜，医生使用一注射器穿过该膜注入或抽出液体。
美国专利US-A-5074868的闭合系统使用缝合线将弹性带两端缝合在一起，从而形成环。
这样的装置一般来说是令人满意的，但是与大多数已知系统一样，它仍具有缺点，在胃成形术植入到适当的位置后，任何需要实施的外科手术都很困难。尽管可以通过上述的微型单元改变环的直径，使之一定程度地延伸，而不需要进行外科手术，但是这样的植入会伴随有不耐性(intolerance)的现象，例如，随着开口(stoma)直径的过多地减小，伴随有呕吐；或者因为开口的直径过大，植入物的功能将失效；或者实际上伴随仅仅局部或全身的发炎或感染或不适。
这就是为什么经常需要再次进行外科手术的原因，不管是为了减轻病人的痛苦，还是修整或改变已经植入的胃成形术环。这样的外科手术特别困难，而且外科医生还需要切除环，或者如美国专利US-A-5074868那样，使用缝合线，以致要将环全部打开然后改变或更换它。
这样的手术实施起来很不方便，病人很少能忍受，而且特别是在要破坏并替换已植入物时费用很高。
发明内容
因此，本发明的目的就是提供一种新的胃成形术环，其使得克服上述各种缺点成为可能，且便于在植入物被植入之后的任何后续的外科手术，而不需要更换植入物，并且在任何情况下，植入物具有特别简单的设计，容易制造。
本发明的另一目的是提供一种新的胃成形术环，其能够以简单和可靠的方式可逆地闭合环体从而形成一个环，同时可以容易地松开两个端部，而不需要破坏该植入物。
本发明的另一目的是提供一种新的胃成形术环，其提供简单和可靠的装置，该装置适于各种不同的特殊外科情形下的精确地调节环的直径。
本发明的另一目的是提供一种新的胃成形术环，其适于提供植入物的多个直径。
本发明的另一目的是提供一种新的胃成形术环，其能减少病人的不舒适感，同时通过环形牢固地保持在适当的位置。
本发明的另一目的是提供一种新的胃成形术环，其特别容易制造并且能提供很好的总体机械强度。
本发明的目的是这样实现的，一种胃成形术环，由一弹性带形成，该弹性带包括第一端部和第二端部，并通过它的两端的靠拢而基本闭合围绕胃部，该胃成形术环使用一个闭合系统通过形成环状来减小开口的直径，所述的带包括一个环形的具有可变容积的压缩腔室，该腔室在所述第一端部通过调节导管与一装置连接，该装置用于调节所述腔室的内部压力，从而调节它的直径膨胀，其特征在于，所述的胃成形术环包括夹持片，该夹持片向环形的外侧突出，从而使得两个端部可以更容易地闭合在一起和分开。
附图说明
阅读以下的描述和从仅作为说明和信息的附图中，本发明的更多目的和优点将变得更明显，在附图中：
图1是本发明的胃成形环的一个实施例的简要透视图，该胃成形环处于被植入前的打开位置；
图2是本发明的胃成形环的一个实施例的简要透视图，该胃成形环处于闭合位置；
图3是示出了在图2中的胃成形环的俯视图。
具体实施方式
图1和图2示出了本发明的胃成形环1的一个优选实施例，其由一弹性带2形成，例如，该弹性带可由适于外科使用的弹性材料加热成形。所述的带2确定了一个内部压缩腔室3，优选地，该腔室基本沿着带的整个长度延伸，腔室3由弹性带2的壁4、第一端部5和第二端部6确定。
所以，如图2所示，在病人胃部的植入位置，压缩腔室3形成了一个环形的压缩腔室。
如在现有技术中所知，压缩腔室3在胃成形术环的内部确定了一个闭合空间，用于形成一个可调节的空间，从而调节环的直径膨胀，同时其处于适当的位置，这是为了使得它可以适应于每个特殊的外科状态。
以常规的方式中，本发明的胃成形环的直径膨胀通过一调节导管7来调节，该调节导管由一管状元件形成，该管状元件为弹性材料，延伸到自由端中的一个，例如压缩腔室3的第一端部5，从而将所述腔室与一装置8连接，该装置用于调节所述腔室的内部压力。
本领域技术人员都知道，调节装置8可以由一微型单元9形成，该微型单元被植入病人的皮肤下。以举例的方式，微型单元9在顶部具有一个自密封膜10，用于被一注射器穿透，从而注入或抽出一确定数量的流体(例如，蒸馏水)，进而改变腔室3的体积，从而调节腔室的体积，因此得到所需要的环的内部直径。因为对于熟知本技术领域的人员来说，这样的装置是公知的，这里不再赘述。
本发明的胃成形术环也具有一个闭合系统，使得它可以被闭合，也有助于将胃成形术环保持在围绕胃部成环状的位置。
根据本发明的一个重要特征，该胃成形术环进一步包括至少一个夹持片，该夹持片从环形向外突出，从而使得在以下情况中环的两端可以更容易地合在一起和分离，即，当环被闭合时和/或为了调整环的进一步操作中，当松开环或是当重新锁紧环时。
如附图中所示，该弹性带2在靠拢环的第一端部5处设有至少一个第一夹持片11。
作为优选，第二端部6包括一第二夹持片12，优选地，它还具有一第三夹持片13。
优选地，每个夹持片11、12、13基本为平面状，并且在第一端部和第二端部之间延伸，所述第一端部固定在环上，所述第二端部为自由端，所述夹持片能通过夹紧而被夹持，从而可以确实地移动端部5和6中的至少一个。
作为优选，所述夹持片是弹性的，从而当胃成形术环被植入病人体内时，这些夹持片可以移动而不挡道。它们都是矩形的形状。
每个夹持片沿着环1的壁4的切线方向延伸，从而夹持片与这个环所在的平面垂直，而且夹持片相对于胃成形术环的整个尺寸而言是较小。特别地，夹持片的厚度相对于它们的宽度和长度很小。
所述夹持片可以与所述带和所述端部5和6的壁整体形成，或者通过机械或化学方式附着在或固定在所述带和所述端部5和6的壁上，例如可以通过粘合或整体模制而成，当然其由不会引起排斥反应的弹性材料制成。
一般地，所述夹持片形成凸起，该凸起可以附着在所述带和端部的壁的外表面或内表面上，从而外科医生可以使用任何外科器械如镊子夹住它，从而使得胃成形术环更容易操作，进而锁紧或解开环。
同样作为优选，所述第一夹持片11的朝向与所述第二端部6的方向相反。第二夹持片12与第一夹持片11的方向相同延伸，同时第三夹持片13与其他的夹持片11和12方向相反。
根据本发明的一个重要特征，本发明的该闭合系统包括用于将环锁紧和松开的装置，该装置通过调节导管7来实现，并使得这成为可能，即，从如图2所示的位置开始，此时环以一锁定的直径闭合成环状，到通过允许环的两个端部6和7相对彼此移动的方式来立刻松开其直径，如果需要的话，仍然还是形成一个围绕胃部的闭合的环形。最好所述锁紧和松开装置是可逆的。
在本发明中，所述锁紧和松开装置包括气动装置，从而确保环的闭合和打开，例如，通过使用流体、气体或液体。该气动装置的使用使得该植入物的安装更加简单，且可以使用一单一控制就实现打开和闭合。
除了简化环的安装和闭合之外，还提供这样的一种技术功能，通过避免截下和破坏已经安装好的胃成形术环，使得在其被植入适当位置后，减少任何基本的外科手术的严重后果和延展成为可能。还具有这样一个功能，可通过使用第一和第三夹持片11、13甚至是第二夹持片来容易地打开该环，这样可在不损坏环的圆圈的情况下使得该环可以留在适当的位置，并且可以随后使用第二夹持片12来重新锁紧该环。
在本发明的一个优选实施例中，如图1到2所示，本发明的胃成形术环包括一个闭合系统，该闭合系统包括：可逆的锁紧和松开装置，所述锁紧和松开装置包括至少一个变形区域15和开口16，该开口16形成在所述带2的第二端部6的壁4上。所述可膨胀的调节导管7由不会引起排斥反应的弹性材料制成，环处于闭合位置时，导管穿过开口16，它还可作为引导装置。
该变形区域15在调节导管7内的压力增加的时候，形成一突起，所述突起抵靠在所述带的第二端部6的壁4上，且在腔室3的内部，从而将环锁紧在闭合位置。如果调节导管7中的压力返回正常，所述突起13也返回静止形状，由此允许所述导管在开口16中滑动或被自由引导，从而松开环体。
根据本发明的一种特别优选实施例，可逆的变形区域15由至少一个强度更小的区域形成，该变形区域在其静止形状时，其构成一个向着第二端部收敛的形状。例如，该变形区域的横截面可以是三角形，也就是说其截面所在的平面垂直于环所在的平面。
优选地，所述变形区域15可由所述调节导管7的一部分形成，由弹性材料制成的调节导管的部分强度要小于调节导管7的总体强度。在这种情况下，调节导管7与一外部调节装置8连接，该外部调节装置通过一流体(空气或液体)加压，区域15趋向于形成一个球状物，该球状物的直径大于所述带的内径，由此锁紧环的直径。该球状物在所述带之前被加压，从而便于球的收敛的形状。
优选地，所述弹性带2在一个端部(例如与第一端部5相对的第二端部6，调节导管7从第一端部5延伸)，设有一空心套筒20，其从弹性带2延伸。
所述空心套筒20在它的一个表面(最好是外表面)上还设有一开口16，从而使得弹性带2的另一个端部5在闭合位置可以插入所述套筒，随后调节导管7穿过开口16，从而形成环形。这样的结构设置确保了可靠的闭合以及长久地维持，同时也使得压缩腔室3沿着整个周长而延伸，沿着整个周长，胃被压迫。
作为优选，所述弹性带2和空心套筒20的横截面都是椭圆形，从而使得当变形区域15被加压时，其更容易被压紧。
优选地，弹性带2、压缩腔室3和空心套筒20形成一个由相同弹性塑料材料制成的单一元件，随后调节导管7通过热焊在其上。
作为优选，所述第三夹持片13从套筒的外表面开始延伸，并且部分地位于开口16之上，但是没有阻碍所述导管穿过开口的通道。
优选地，可以使得变形区域15的厚度制成与弹性带2的厚度不同，从而在这些元件中的每一个中得到不同的流体流速。不同的流速也可以通过不同的形状来得到，例如，由此可使弹性带2在变形区域15之前缩小。
优选地，所述弹性带2的端部5是锥形，弹性带与调节导管7连接，从而便于将所述导管插入空心套筒20中。所述变形区域15位于所述锥形的内部。
这些限位挡块25由例如材料的剩余物制成，其形成一个面向该环外侧的块体，该限位挡块可防止胃成形术环的不希望有的松开。这些装置的夹紧使得这成为可能，即，检查所述导管是否滑动进入开口16足够远，从而可以得到正常的胃成形术环的直径。这还确保了该突起被保持在中空套筒中的固定的适当位置。
而且，所述调节导管7基本上是刚性的，且相对于环的直径而言是长的，从而可以更容易地将导管7穿过所述开口16。这也确保了在所需位置的带的良好定位。
作为一个单一元件来制造胃成形术环简化了制造环的方法，同时使得所述的环可以避免随时间的流逝而裂开的危险。
在植入过程中，当本发明的环围绕着胃部要放入适当的位置时，该环处于如图1所示的位置。调节装置8起初没有被连接，外科医生将调节导管7穿过开口16，从而将第一端部5插入空心套筒20中(参见图1)。随后，外科医生使用第二夹持片12将限位档块带入开口16中的固定位置。然后他可以使用与单一导管连接的调节和膨胀装置8将环固定在适当的位置。接着，外科医生可以使用调节导管7注入或抽出适量的液体来调节环的内径。应该注意到，所有的操作都是使用单一的导管7来完成的。
在需要后续外科的情况下，依靠根据本发明的胃成形术环，使得这成为可能，即，使用体腔镜检查术或腹腔镜检查植入物的位置，或是仅仅通过使用摄象机进行光学检查，从而将手术限定在表面外部的检查。如果需要将位置改变为合适，使用简单的腹腔镜就可以解开胃成形术环。为了完成这些，所需要的做只是将导管7置于低压之下，这将导致带的紧缩并使球状体松开。对于两个端部5和6所需要做的就是通过在第一和第三夹紧片11和13上作用而分离端部。因此，所述夹紧片容许限位挡块25从开口16脱离。然后，该导管可滑动穿过开口16。还可以使用第二夹紧片12取出限位挡块并打开环；该环被翻转到与第一夹持片11的相反方向。
这样的滑动通过环的部分和瞬间的松弛而完成，而无需在病人身上进行一系列的手术。
需指出的是，在松开的过程中，根据本发明的胃成形术环具有夹持片，这夹持片在松开的过程中都是以相反的方向来操作，从而使得环承受的是基本对称的相反作用力。在松开的过程中，因此，围绕胃部放置的环不会有移动的趋势。
还可以通过简单的腹腔镜检查和手术再次将环闭合，并以非常简单的方式将环固定在闭合位置，这是因为环的环形从来就没有被破坏。
因此，容易理解所述夹紧片11到13具有便于锁紧环的功能，并使得在不毁坏环的情况下将环松开成为可能。
工业应用性
本发明的工业应用在于制造和使用胃成形术环。

Claims (13)

1、一种胃成形术环，由一弹性带(2)形成，该弹性带包括第一端部(5)和第二端部(6)，并通过它的两端(5，6)的靠拢而闭合围绕胃部，该胃成形术环使用一个闭合系统通过形成环状来减小开口的直径，所述的带(2)包括一个环形的具有可变容积的压缩腔室(3)，该腔室(3)在所述第一端部(5)通过调节导管(7)与一装置连接，该装置用于调节所述腔室的内部压力，从而调节它的直径膨胀，其特征在于，所述胃成形术环包括至少一个夹持片(11，12，13)，该夹持片向环形的外侧突出，从而使得两个端部(5，6)可以更容易地闭合在一起和更容易地分开。
2、根据权利要求1所述的环，其特征是，所述的环在靠近第一端部处包括至少一个第一夹持片(11)，该夹持片容许第一端部(5)从第二端部(6)分离。
3、根据权利要求2所述的环，其特征是，所述第二端部包括至少一个第二夹持片(12)，该夹持片容许这些端部闭合在一起和/或容许这些端部分离。
4、根据权利要求3所述的环，其特征是，所述第二端部(6)进一步包括至少一个第三夹持片(13)，该夹持片容许第二端部(6)从第一端部(5)分离。
5、根据权利要求4所述的环，其特征是，所述夹持片(11，12，13)都是基本为平面形状，并且在第一端部和第二端部之间延伸，所述第一端部固定在环上，所述第二端部为自由端，所述夹持片能通过夹紧而被夹持，从而可以确实地移动上面安装有夹持片的环的端部。
6、根据权利要求5所述的环，其特征是，所述第一夹持片(11)的朝向与所述第二端部(6)的方向相反，第二夹持片(12)与第一夹持片(11)的方向相同，第三夹持片(13)远离第二夹持片(12)。
7、根据权利要求2至6中任一项所述的环，其特征是，所述闭合系统包括用于闭合和松开环的气动装置(15，25)。
8、根据权利要求7所述的环，其特征是，所述气动装置(15，25)被装在调节导管(7)中，该气动装置包括至少一个变形区域，在所述带的第二端部(6)的壁(4)上形成有开口(16)，调节导管(7)在开口(16)中滑动，从而形成胃成形术环的环状；一方面，在导管中压力增大的情况下，所述变形区域(15)能够部分地形成一个突起，另一方面，在返回到正常压力的情况下，所述变形区域能够回复到其静止时的形状，从而容许调节导管(7)自由滑动且松开环状。
9、根据权利要求7所述的环，其特征是，所述变形区域(15)是形成在所述调节导管(7)上的一个强度更小的区域。
10、根据权利要求8或9所述的环，其特征是，所述弹性带(2)的第二端部(6)设有一中空套筒(20)，所述套筒具有开口(16)，从而所述弹性带(2)的第一端部(5)能够插入所述套筒(20)中。
11、根据权利要求10所述的环，其特征是，所述带的第一端部(5)为收敛的形状，且包括变形区域，该变形区域的截面为三角形状。
12、根据权利要求1至11中任一项所述的环，其特征是，所述带的截面为椭圆形状。
13、根据权利要求1至12中任一项所述的环，其特征是，所述调节导管(7)与一用于对其加压和减压的装置(8)连接。
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EP1389453B1 (de) * 2002-08-16 2007-03-07 AMI Agency for Medical Innovations GmbH Band zur Erzeugung einer künstlichen Verengung im Gastro-Intestinal-Trakt

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100370953C (zh) * 2003-09-30 2008-02-27 伊西康内外科公司 分段胃用收扎带
CN1895186B (zh) * 2005-07-15 2012-06-06 伊西康内外科公司 具有端部配合外形的胃束带
CN103237506A (zh) * 2010-12-01 2013-08-07 伊西康内外科公司 腔内衬垫和为中空器官腔内加衬的方法
CN103237506B (zh) * 2010-12-01 2016-01-20 伊西康内外科公司 腔内衬垫和为中空器官腔内加衬的方法

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US7824422B2 (en) 2010-11-02
ES2232622T3 (es) 2005-06-01
RU2002133456A (ru) 2004-04-20
MXPA02011097A (es) 2003-09-10
MA25670A1 (fr) 2002-12-31
WO2001085071A1 (fr) 2001-11-15
US20070004963A1 (en) 2007-01-04
FR2808674B1 (fr) 2002-08-02
DE60106456D1 (de) 2004-11-18
DK1303237T3 (da) 2005-02-14
CA2408080A1 (en) 2001-11-15
IL152731A0 (en) 2003-06-24
BR0110765A (pt) 2003-02-11
AU2001260407B2 (en) 2006-09-21
PT1303237E (pt) 2005-03-31
ATE279166T1 (de) 2004-10-15
TNSN02091A1 (fr) 2004-03-05
EP1303237B1 (fr) 2004-10-13
EP1303237A1 (fr) 2003-04-23
AU6040701A (en) 2001-11-20
FR2808674A1 (fr) 2001-11-16
US20040049209A1 (en) 2004-03-11
JP2003532492A (ja) 2003-11-05

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