CN1630508A - 用于调整柔性区的聚合体植入物的外科手术器械和方法 - Google Patents
用于调整柔性区的聚合体植入物的外科手术器械和方法 Download PDFInfo
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Abstract
一种调整解剖学结构的支撑量的侵害性最小的方法。所述方法和装置包括使用一根带来支撑解剖学结构。通过在该位置直接使用膨胀剂或把膨胀剂注入固定在带附近的容器装置来实现调整,从而膨胀剂和该带联合作用来支撑该解剖学结构。另一个方法是使用机械装置,能调整用于支撑解剖学结构的带的支撑臂的有效长度。
Description
相关申请的相互引用
本发明要求了1999年6月9日所申请的序号为60/138231的美国早期申请的临时专利申请的权益,在这里整体引入作为参考。
发明背景
本发明通常涉及一种侵害性程度最小的方法,以调整支撑解剖学结构的柔性区的聚合体植入物,还涉及一种特别有用的使用植入物支撑尿道以治疗女性小便失禁的方法。
多于一千一百万的女性有失禁的情况。而且,大多数失禁的女性患的是压力小便失禁(SUI)。患有SUI的女性在正常的日常活动和运动期间,例如大笑、大哭、打喷嚏和常规锻炼中,会不由自主地遗尿。
阴道壁与骨盆肌肉和耻骨相连的组织或韧带的功能性缺陷可能引起SUI。通常由包括骨盆肌肉的反复性拉伸、生小孩、骨盆肌肉缺少韧性和缺少雌激素引起。这种缺陷使得尿道功能不正常。SUI不象其它类型的失禁,它不是膀胱引起的问题。
通常,当尿道由有力的骨盆底部肌肉和健康的连接组织正确支撑时,尿道能保持紧固密闭,以阻止不由自主地遗尿。然而,当女性患有SUI的最普通形式时,变弱的肌肉和骨盆组织不能在它的正确位置充分支撑尿道。因此,在正常运动期间,从横隔膜对膀胱施加压力时,尿道不能保持其密闭,从而让尿漏出。因为SUI既令人难堪又不可预期,很多患有SUI的女性避免活跃的生活方式,并且羞于参加社会工作。
美国专利5112344描述了一种用于治疗女性失禁的方法和器械。应用长纤维件进入人体内的该外科手术器械,其一端包含一个有把手的管状轴,而其另一端包含一个柔性针,该柔性针可滑动地接纳在轴内,用于接纳长纤维件。这种治疗女性小便失禁的方法包括,使长纤维件在阴道壁和腹部前壁内的直肌腹鞘之间结成环,从而使它通到尿道的每一侧,调整环可使阴道壁和尿道相对于耻骨形成正确的空间关系,使阴道壁和腹部耻骨的前壁之间的疤痕组织生长愈合,然后取出长纤维件。
美国专利5899909公开了一种外科器械,其一端包含一个有把手的轴,而另一端包含连接装置,连接装置用来接纳两个针状件,每次一件,该针状件的一端与准备用来植入人体内的带的一端相连。实际上,带的一端首先穿过阴道进入人体,然后带的另一端分别在尿道的一侧和另一侧形成一个围绕尿道的环,并固定在尿道和阴道壁之间。使该带越过耻骨延伸,并穿过腹部壁拉紧。该带的两端在腹部壁被切断,而留下该带植入人体内。美国专利No.5899909在这里引入作为参考。
在植入带的同时,通常很难确定对尿道结构提供的最合适的支撑量。最理想的支撑量限定为能够减轻失禁的痛苦和同时正常排尿。即使在植入过程中能提供最理想的支撑量,还有可能周围组织在治愈过程中或完全由于老化会变化。因此,理想的支撑量要能够变化。
在欧洲专利0941712A1中,JoséGil-Vernet Vila描述了一种方法,该方法使用从尿道远端植入并与一个支撑尿道的网状物相连的可扩展的容器来调整对尿道的支撑。虽然这样提供了调整性能,相关的外科手术操作具有侵害性,并且是复杂的。该容器也是复杂的,并且要求确保该悬挂纤维具有不会磨损的性能。该容器最好放置在腹部区域内的脂肪组织中。只要对腹部区域施加外力,该容器的位置使其容易产生变形。这将能暂时改变对尿道的支撑程度,而希望的是能提供一种相当恒定的对尿道的支撑程度。由于网状物支撑直接与尿道接触,对尿道的支撑的波动可刺激周围组织。
在美国专利No.6042534中,Gellman et al.描述了使用辐射透不过的目测指示器。但是,没有具体描述怎样达到这种效果,并且没有提到其具有带支撑装置的使用。而且,这个指示器的用途只是评估用于支撑尿道的吊环的相对位置。Gellman没有记载关于在吊环就位后针对吊环的调整。
在美国专利No.5611515中,Theodore V.Benderev et al.描述了联合膀胱颈部悬挂物的缝合拉紧装置。用这些拉紧装置来调整把支撑吊环固定在膀胱颈部的位置处的缝合线的张力。在缝合之前,通过合适的张力把缝合线向前绕在缝合拉紧装置上,并以传统的方式缝合。然后,移走缝合拉紧装置,并以传统的方式准备好手术点位置,并缝合外科手术点位置。但是对于建立对吊环的初始张力要求精巧的技术,而不允许过度的植入调整。对于用缝合线或其它细纤维装置悬挂吊环的地方也要求这种精巧的技术。但是,这种拉紧装置不适合于用于失禁的植入带,例如那些联合GYNECARE TVT无拉力支撑的带。
国际专利WO98/31301公开了一种可植入的节制装置,该装置包括液压和机械部件。
因此,需要以一种不复杂的方式且没有尿道与网状物接触来调整对尿道的支撑程度。而且,该调整装置应该位于紧靠需要支撑的地方。
本发明公开了在植入期间和在植入之后调整对内部解剖学器官的支撑的装置和方法。具体而言,本发明对用于支撑尿道的植入物将是特别有用的。
发明内容
本发明克服了现有技术的不足,并提供了调整植入带对解剖学结构的支撑程度的一种改进的器械和方法。本发明对治疗女性小便失禁有特别的效用。
本发明的装置对治疗女性小便压力失禁特别有用。该装置提供了一种外科手术器械,其一端包括一个把手,而另一端包括连接装置,连接装置用来接纳两个针状件,每次一件,每个针具有改进的顶端。该针有一个恒定的或变化的直径。每个针的一端与准备用来植入人体内的带的不同端相连。实际上,带的第一端由一个弯曲的针经尿道一侧的阴道进入人体。针和带的第一端越过耻骨,并穿过腹部壁。第二个针件与带的第二端相连,并从带的第一端所在的尿道相反位置处的阴道穿入人体,从而用带形成围绕尿道的一个环或吊环。使该带的第二端越过耻骨延伸,并穿过腹部壁。该带的两端在腹部壁被切断,并且留下该带植入人体内。
本发明还提供有一个改进顶端的单个弯曲的针状件。该针有一个恒定的或变化的直径,而且还提供了一个简易的连附装置,该连附装置能使外科医生把带的第一端和第二端都与单个针相连,以进行上述手术。
在两个实施例中,本发明提供了能调整植入带对尿道的支撑程度的器械和方法。在此提供了两种方法。一种方法涉及到膨胀剂的使用,该膨胀剂被包含在周围组织内,并直接注入周围组织内。这种方法提供了能检测到的标志,可在注入过程中指引临床医生。第二种方法提供了机械装置,用于调整支撑尿道的带的支撑臂的有效长度。这些装置包括细丝状的可调整的结构。
本发明的目的是要提供一种方法,可调整植入带对解剖学结构的支撑程度。
本发明的一个优点是,它提供了用于支撑解剖学结构的植入带的连续调整的能力。
结合以示例方式说明本发明原理的附图,从以下更详细的描述中可明显看出本发明的这些和其它特征和优点。
附图简述
图1为供带形网状物使用的针的视图;
图2a为两个针和把两个针连接起来的一根带的侧视图;
图2b-2d为带以及在带和针之间的连接装置的其它实施例;
图3a-3g为把带与针相连的装置的实施例;
图4a-4f为设有与带形网状物相连的可膨胀容器的其它实施例;
图5a-5c为设有调整带形网状物的机械装置的其它实施例;
图6a-6h图示了根据本发明使用两个针治疗SUI的方法的几个外科手术步骤;
图7a-7h图示了根据本发明使用一个针治疗SUI的方法的几个外科手术步骤;
图8示意表示了在带和尿道之间的直接膨胀;和
图9示出了在带中的一个可检测到的目标环。
发明详述
在详细说明本发明前,应该指出的是,由于本发明示例性的实施例可以补充或引入其它实施例、变型和改进,还可以不同的方式实施或实现,本发明不限于在附图和说明中所示的治疗女性小便失禁的应用或部件的结构和安装的细节。此外,除非另外指出,这里用于描述本发明的示例性的实施例而采用的术语和表达语,是为了读者方便而不是为了限制本发明而选用的。
本发明公开了用于治疗SUI的一种器械和方法。一根带穿过骨盆组织,并位于尿道下,形成了一根起支撑作用的吊环。该带提供了一种用于组织生长的结构装置,从而提供了一个新形成的身体组织支撑尿道装置。当对下腹部施加压力,例如大笑或打喷嚏,该带给尿道提供支撑,并使它保持密闭以防止不想要的排尿。
参照图1和2a,该外科手术器械包括一个针状件10,该针状件10与网状带12相连。该针状件10确定了某一半径R来进行在这里论述的外科手术操作。针状件10的远端终止于圆锥形部分14,该圆锥形部分14有一个顶端16。在另外的结构中,也有可能有例如刀状、箭头或针球状的顶端。顶端16优选为钝状,其中顶端16的半径大约是0.6毫米。优选钝状顶端,是因为它不太可能粘在骨头上,或穿透膀胱壁组织或血管壁组织,在如下所述的植入带的方法中将会理解这一点。
针10的近端终止于连接部分20,该连接部分20适用于紧密配合和锁入把手411,如前面在美国专利No.5899909中所述,在这里引入作为参考。
弯曲轴部分18设置在锥部14和部分20之间,其有一个远端17和一个近端19。轴18的形状大致延伸成圆的四分之一,使其大致跟随阴道和腹部壁之间的耻骨的轮廓。为了这个将在下面更详细论述的方法,轴18优选的半径R大约是106毫米。弯曲轴部分18的直径可以是恒定的,或者部分18的直径可以从远端17的较小直径逐渐变化到近端19的较大直径。由于在远端的应力最小,所以远端17的最小直径可以小到0.5mm。近端19的最小直径可约为4mm。优选的是,近端19的最小直径约为6mm,且以连续减少的方式使远端17的最小直径约为3mm。这种设计考虑到,在植入带12的方法中,在远端17的弯曲应力最小,而在近端19的弯曲应力最大。不同的说法是,在手术中在远端17的内弯曲运动可以忽略不计,而在近端19的内弯曲运动是相当大的。
针10优选为圆形截面,并由可与人体相容的材料制成。针10还优选为由可高压灭菌的材料制成,使针10能进行多个外科手术操作。针10还优选为由303不锈钢制成。轴18的表面可以是光滑的,最好是打磨过的,以便于穿过软组织。另外,针10的表面可以是稍微有点粗糙的表面。较粗糙的表面可能导致轻微的、附加的组织损伤,这样又刺激了带12周围的纤维原细胞的活性。
针10可作为单一的、连续的装置制造,或者可选择的是,弯曲部18可与线性部20分开制造。在这种方式中,两个部件将用任何一种传统的连接装置来连接,例如螺纹,或是本技术领域中的技术人员所熟知的其它传统的装置。
参照图2a-2d,带12包含任何一种与组织相容的合成材料,或是任何一种天然材料,包括但不限于自体同源、代植入、外植入、组织工程基体或是它们组合而成的组织。合成材料的例子是由美国新泽西州Somerville的Ethicon公司制造的PROLENE聚丙烯网,该网厚0.7mm,开口大约1mm。该材料由美国食品和药品管理部门批准可用于植入人体内。还有带12的另一个实施例,其包括合成材料11和天然材料13的组合物,天然材料13在合成材料11的中央,见图2b-2c所示。还有带12的另一个实施例,其包括合成材料11和天然材料13的合并物,而天然材料13放置或混合在合成材料11的大概中央部分内。带结构的一个优点是,天然材料13处于沿带12的中央区域,使得带12安装后,天然材料13位于尿道下面,并且能消除在尿道和带的接口处可能发生的腐蚀问题。天然材料13可通过缝制、生物相容的胶、细胞培植技术或其它的已知方法与合成材料11相连。
带12可以具有适合本发明目的的任意一种方便的形状。带的一个实例的宽约为1cm,而其长度将依赖于进行该手术的女性的尺寸。带12可以是单层或双层,通常是平面结构,或是管状(图2d),以提供一个附加的支撑力和更多的表面区域,组织纤维可连接于该表面区域上。而且,带12可以包含不同类型的材料,例如一种生物可吸收和非生物可吸收的材料。带12还可以涂有一层抗菌添加剂和一层光滑涂层,抗菌添加剂用来防止感染或使感染最小化,而光滑涂层,例如生物可吸收的水凝胶,以便于带穿过如下所述的组织。带12优选为覆盖有一层可去掉的塑料套,如美国专利No.5899909中所述。该带还可以制成辐射透不过的和/或具有与身体组织相对照的颜色,用于将来的诊断观察。
参照图4a-4f,带12还改进成包括一个可膨胀的容器或腔100设置在带12上,使得在手术操作之后,该腔100位于尿道和带表面之间,如下所述。容器100用来限制膨胀剂的移动和/或再吸收。此外,把膨胀材料注入腔100时腔100会膨胀,或者从腔100抽取膨胀材料时,腔100会收缩。
腔100可由可生物相容的材料制成,例如水凝胶(即交联的甲基丙烯酸-PEG脂、PHEMA、PMMA、磷脂类甲基丙烯酸聚合物、辐射交联的PEO或PEG)、聚丙烯、聚脂、硅树脂或聚亚安脂。该容器可以是与带成整体的部分或是可滑动式连接,使得其位置设置成在支撑尿道时与带一起协调工作。该位置应该靠近网的中央,使得在植入后容器100位于尿道区域的下方。容器100可选择有一个可接触的内部阀件101,以使外科医生在注入或取走膨胀剂之前能触诊该区域。另外,该膨胀剂可通过一个双向外部口102被注入或取走。当膨胀剂被注入容器100,在网和尿道之间的组织将膨胀。这导致两个结果:由于膨胀而引起自然的垂向升起和由于拉伸网的外侧而引起垂向升起。适合的膨胀剂可以是水或盐水。
容器100优选为在倒过来时不会有空隙,其高度约为0.5cm-2cm,而其长度约为2cm-4cm。容器100可是图4a中的立方体状可膨胀件,或是图4b中的圆屋顶形。该容器100还包括一个适用于连接到带12上的底部103。可通过在带的两侧的水凝胶把带加到底部上来实现连接,如图4b所示。由于聚丙烯材料不接受粘性材料,所以当带是聚丙烯网时优选采用底部103。优选采用该结构是因为容器100提高了带12在容器连接区域中的有效弯曲硬度。
或者,容器100可包含两个彼此流体连通的腔100a、100b。或者,所述两个腔100a、100b可是单独的和有效的两个容器。但是它们由一个共同的注入口连接在一起。这种结构允许在尿道下面和侧面的组织膨胀。
网12中增加容器100能够起到提高带12在容器100的连接区域中的有效弯曲硬度的作用。当带12植入时,提高的弯曲硬度能对尿道提供辅助支撑。当容器100充满膨胀剂时还可提高该弯曲硬度。
如果容器100是半渗透性的,则注入的膨胀剂可设计成具有渗透张力的优点以确保充分的充填体积。同样,由水凝胶制成的容器100可具有微小的渗透张力调整作用。另外,该注入物从容器里扩散到周围组织可实现药物的传输。
例子1
使用商业上可得到的6cm×4cm的组织膨胀装置可制造容器100,该装置可从Mentor Deutschland GmbH中得到,其分类号为350-5301M。该组织膨胀装置包括一个与其一端相连的远端双向注入口102。该组织膨胀装置在纵向上宽度被截为2cm。上下壁沿截断长度使用氰化丙烯酸脂胶临时密封在一起,随后使用硅粘合剂永久地密封,如下所述。这样使得容器具有约1.5cm的宽度。一个聚丙烯网放置在容器上。硅粘合剂(硅单体和催化剂组分)被刷到在容器上面和在容器下面的网状部分上。在固化一个晚上后,所述网牢固地与容器相连。带有外部开口的可膨胀的容器很容易和可逆地膨胀。所制造的容器100沿着其与网相连的区域提供了增加的弯曲硬度。
例子2
一个造型与例子1中相似,只是注入口是一体化成可膨胀容器一侧的整体部分。通过在网12上设置开口104以便插入注入口102a,将容器安置在网12上,如图4c-4d所示。
图4e描述了一种双壁自密封容器100,该容器减少了对单独的注入口的需要。容器100包含一个内部腔100c,该内部腔优选包含一个中央定位的塑料或金属边界105以阻止在注入膨胀剂时针穿透较远的壁。例如在用针注入膨胀剂时,分别在内部腔100c和外部腔100d的壁中形成刺透孔。在取走注入装置后,原来严格对齐的内部腔和外部腔的刺透孔被移位。这种移位使该注入位置被有效地密封。
或者,可使用单壁自密封容器。这种容器的内层有一个柔软的塑性变形涂层。该涂层用来充填任意的注入刺透点,从而使容器密封。
带12还可改进成包括机械调整装置,在带已经植入后用来调整带,如下所述。该机械调整装置合并有缝合线106和106a,缝合线106和106a位于带12的中央部的任意一侧,如图5a-5c所示。缝合线106和106a可与单向缝合保持装置108联合使用,如美国专利No.5669935中所述,其整体内容插入这里作为参考。使用任意生物相容的粘合剂或本技术领域的技术人员熟知的连接使保持装置固定在带12上。另一种装置包括一种系结-缠绕类型的装置来调整在尿道54附近的带12的一侧或两侧的长度,并同缝合线106和106a的设置相似。在任意一个例子中,如下所述,在带植入后的一段时期内,通过阴道中的切口保持可接近缝合线106和106a或系结-缠绕。在重要组织生长之前并在该手术后很多天,都将适合调整带。随后,露出的缝合线或系结-缠绕可被切断。
在一个实施例中,带12可通过打结、胶合或其它适合的连附装置与针的部分20相连。一种生物相容的热收缩管把带12固定到针的部分20上,见图2a。在另一个实施例中,如图2b-2d和图3a-3h,针10和带12还具有这种结构,使得在操作中外科医生很容易把带12连接到针10上,以及把带2从针10上取下。该实施例允许在手术中使用单个针10。由于这些天然材料不能经受住存货延长时间的考验,这个实施例中还允许使用至少部分是由天然材料构成的带,否则它们不能适用于预固定的实施例。
如图3a-3c中所示,在一个实施例中,轴18设置了一个凹口或狭槽40,用于可滑动地接纳用于连接的接头32和32a,接头32和32a可连在带12的任意一端(见图2b-2d)。狭槽40优选贯穿弯曲轴18,并且还位于针10的远端17处,以使针10穿过腹壁之后,带12可马上从针10上取下,如下所述。
接头32可由例如塑料或金属的生物相容的材料制成。只要接头32能牢固插入凹口或狭槽40中,接头32可以是任意形状,例如方形或箭头形。图3b-3c示出了接头32,其具有两个弹性臂33和33a,当插入到狭槽40中时,弹性臂33和33a展开,并且把接头32牢固地固定在狭槽40内。接头32可以任意多的方便的方式与带12相连,这些方式如前所述,并且是该技术领域中的技术人员所熟知的。
图3d-3e示出了一个两层的狭槽40,其中接头32和弹性件33b滑入下层,该下层把接头32固定就位。还可利用在狭槽40中接纳接头32的另外方式,这些在技术领域中是众所周知的。
图3f-3g示出了把带12固定到针10的远端17a的另一个实施例。可拆卸的钝状顶端16d有一个连接柱15,钝状顶端通过安装孔15a接纳柱15来与远端17a相连。柱15可通过压接、螺纹配合或其它方便的连接方式牢固地连接在孔15a上。远端17a还确定了有不同深度的沟槽23,使与柱15相连的带12的端头从孔15a中移动到针10的外部。本实施例和图3a-3e的实施例一起,允许外科医生仅仅在外科手术之前才把带12固定到针10上。一个优点是能够使用一个至少部分由天然材料13构成的带12。
在本技术领域的技术人员将会理解这一点,即存在多种装置可把带可拆卸地连接到针上。另一个实施例包括把带12的端部打结以形成一个结,并把该结牢固地插入轴18的V形槽中。另外,轴18上的一个斜缝能够接纳带12或从带12延伸的一个缝合线。
使用两个针植入带12的外科手术的操作如图6a-6h中所示,使用针的实施例如图1-2a中所示。在图中示出了女性下腹部相关的部分,如阴道50、子宫52、尿道54、耻骨56、泌尿膀胱58和腹部壁60。第一个针10a穿入阴道壁,最初已在阴道壁上开了个切口以制造一个组织片状物。针与把手411相连,外科医生引导针10a穿过阴道壁和穿过尿道54一侧的软组织,然后按照图6b所示,针穿到靠近耻骨56的后部,穿过另外的脂肪层、肌肉层和筋膜层,接着又穿过耻骨56上方的腹部壁60。制造一个切口穿过腹部壁,用作针经过腹部壁的通道。把手411从针10a取下,见图6c,并且针10a与带12一起通过镊子从腹部壁抽出,见图6d。
参照图6e,此时针10b与把手411相连。外科医生使针10b穿过阴道壁的切口,再穿过不同于带12前一次终端的尿道相反侧的软组织。针10b靠近耻骨的后部穿过另外的脂肪层、肌肉层和筋膜层,见图6f,接着又穿过在耻骨上方的腹部壁并取出,见图6g。
图7a-7g示出使用单个针10植入带12的另一种方法。带12通过弹性接头32与针10相连,如图3b-3c所示。针10穿过阴道壁,阴道壁中首先已做好一个切口用于制造一个组织片状物。外科医生引导针10穿过阴道壁和穿过在尿道54一侧的软组织,然后按照图7b,针靠近耻骨56的后部穿过另外的脂肪层、肌肉层和筋膜层,接着又穿过在耻骨56上方的腹部壁60。穿过腹部壁可以做一个切口,用作远端17经过腹部壁的通道。针10继续穿过腹部壁,一直到接头32可以从针10分离为止,见图7c。为了这么做,外科医生简单使用适当的器具通过槽40推接头32和断开接头32并用镊子拉出接头32。然后接头32被断开,带12可被拉出腹部壁,以使外科医生有额外长度的带用于手术操作。接着针10沿着它进入的同一路径,只不过从相反方向从病人体中取出,见图7d。另外,如用两个针的操作中所述,针10可从把手411上分离,并用镊子从腹部壁60拉出。
现在针10用连接器接头32a与带12的相反端连接。外科医生把针10穿过阴道壁的切口,然后穿过不同于带12前一次终端的尿道相反侧的软组织,见图7e。针10靠近耻骨的后部穿过另外的脂肪层、肌肉层和筋膜层,见图7f,接着又穿过在耻骨上方的腹部壁。针10继续穿过腹部壁,一直到接头32可以从针10分离为止,见图7g。带12可被拉出腹部壁,以使外科医生有额外长度的带用于手术操作。接着针10沿着它进入的同一路径,只不过从相反方向从病人体中取出。另外,针10可从把手411上分离,并用镊子从腹部壁60拉出。
由于所有手术操作可以使用局部麻醉进行,病人能够在带12放入就位后给外科医生提供反馈。典型的是泌尿膀胱58充满例如水的流体、使用导尿管和要求病人咳嗽。如果必要,外科医生能确定尿道的操作,可通过调整位于腹部60的外侧的带12的端头来调整带12,见图6h和7h。在调整之后,剩余的带在腹部被切断,带的两端固定在腹部内,并缝合腹部。同样,缝合在阴道壁的切口,从而组织片状物把带密封在尿道54和阴道50的壁之间。
带12留在身体里,并形成一个与腹部壁相连的人工韧带,能如所要求的给尿道提供支撑,从而恢复病人的小便节制。
在图6和图7中公开的任一手术结束时,外科医生可进行一个试验操作来确定泌尿膀胱的完整性。可通过穿过尿道放置一个刚性的内窥镜/护套和通过护套把流体注入膀胱来进行膀胱的水压诊断。膀胱被充压到已知的如通过护套测量约50mm汞柱的水平。如果维持此压力,则外科医生能确定膀胱没有被穿透。相反,如果膀胱压力减少,则要采取步骤以修复任何缺陷。
可通过在带吊环附近注入膨胀剂进行带的外科手术后调整,以给尿道提供辅助支撑。膨胀剂优选在网的上方注入,以使在网和尿道之间的组织膨胀(直接膨胀),见图8所示。该操作可与具有可膨胀腔的带12联合使用或单独使用。适合的直接膨胀剂包括DURASPHERES、CONTIGEN、MACROPLASTIQUE和聚四氟乙烯和合成的、天然的可缓慢吸收的材料或不可吸收的材料。膨胀剂必须是稳定的、生物相容的,并且在没有容器直接注入的情况下,必须能阻止移动。该膨胀剂可以是可探测的(例如辐射透不过),例如有DURASPHERES的情况,或可包含一种对照组分,能使该膨胀剂的位置和数量可见。
为了把膨胀剂注入容器100(图4a-4f),外科医生将触诊该区域以检测容器的注入点,如果需要,可在阴道壁做一个小切口。或者,标记可以是单独的部分或是容器或带的一体化部分。例如,可使用超声波对注入提供指引。这可优选通过直肠放置传感器来实现。然后适合的膨胀剂仅通过阴道或尿道的局部麻醉来注入。
如果需要,可使用辐射透不过的垫圈提高该目标区域的超声波诊断的可检测能力。参照图9,可使用一个x射线可检测的聚丙烯(例如由Ethicon公司生产的Prolene)衬环109。示例性的环109的内径为0.5cm,外径为1cm,厚度为0.5mm,并包含6个1.5mm直径的二氧化锆垫圈(由德国的Mhlmeyer Mahlechnik生产,含95%ZrO2/5%Y2O3),作为环绕网12的开口的辐射透不过物。环109使用超声焊接装配在带12的中央。这些x射线辐射透不过物是适合的植入材料,也是超声波中可见的材料。
环109还用于x射线指引注入。在带植入后,在带周围的区域可能膨胀,该区域具有由x射线指引注入的膨胀剂。通过使用计算机化的x线断层摄影术可确定目标环109(和相应带)和辐射透不过物充填的尿道、膀胱和膨胀剂(例如辐射透不过的DURASPHERES)的确切位置。
从已示出和描述的本发明的特定形式的上述内容将明显看出,在不背离本发明的精神和范围的情况下可做出不同的变型。因此,除了附加的权利要求书,它不会用来限定本发明。
Claims (9)
1.一种用于治疗女性小便压力失禁的外科手术器械,其包括:
a)一根用于植入女性下腹部、能给尿道提供支撑的带,其包含在所述带植入后用于调整所述带的调整装置;和
b)一个部分限定一个弯曲轴的弯曲的针状件,所述弯曲轴具有一个远端、一个近端和用于连接带的装置。
2.如权利要求1所述的外科手术器械,其特征在于,所述调整装置是一个可膨胀腔。
3.如权利要求1所述的外科手术器械,其特征在于,所述调整装置是一个能穿过带的缝合线状件,从而当该缝合线状件被拉紧时,带能对尿道提供辅助支撑。
4.一种用于治疗女性小便压力失禁的外科手术器械,其包括:一个用于植入女性下腹部的带,能给尿道提供支撑,所述带限定一个第一端、一个第二端和用于接纳膨胀剂的可膨胀腔。
5.一种用于治疗女性小便失禁的方法,其包括以下步骤:
a)提供第一和第二弯曲针状件,每个针状件部分限定一个弯曲轴,该弯曲轴具有一个近端和一个远端,并且一根带与两个针状件都相连,所述带包含一个用于接纳膨胀剂的可膨胀容器。
b)使第一个针和带经阴道和尿道一侧穿入人体,使带延伸越过耻骨,并穿过腹部壁;
c)使第二个针和带经阴道和不同于第一个针的尿道相反侧穿入人体,带延伸越过耻骨,并穿过腹部壁,在尿道下形成一个吊环;
d)留下带植入人体内;和
e)把膨胀剂注入可膨胀容器内。
6.一种用于治疗女性小便失禁的方法,其包括以下步骤:
a)提供一个弯曲的针状件,其部分限定一个弯曲轴,所述弯曲轴具有一个远端和一个近端,并包含一根带与针相连,所述带还包含用于调整该带的调整装置;和
b)使针和带经阴道穿入人体,并环绕尿道形成一个吊环;
c)留下带植入人体内;和
d)使用调整装置调整所述带。
7.一种用于治疗女性小便失禁的方法,其包括以下步骤:
a)提供一个部分限定一个弯曲轴的弯曲的针状件;
b)把一根带与所述针相连;
c)使针和带穿入人体;
d)把所述带与所述针相连,并使所述针与所述带穿入人体环绕尿道形成一个吊环;
e)留下带植入人体内;和
f)在植入后调整所述带。
8.一种用于治疗女性小便失禁的方法,其包括以下步骤:
g)提供一个部分限定一个弯曲轴的弯曲的针状件;
h)把一根带与所述针相连;
i)使针和带穿入人体;
j)把所述带与所述针相连,并使所述针与所述带穿入人体环绕尿道形成一个吊环;
k)留下带植入人体内;和
l)在带和尿道之间注入膨胀剂。
9.一种用于支撑内部解剖学结构的装置,该装置包括一个网状带和一个可膨胀的腔,所述可膨胀的腔具有能容纳不同量的膨胀剂的能力,其特征在于,所述可膨胀的腔固定在所述网状带上,并位于网状带和解剖学结构之间。
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- 2000-06-07 CN CNB008113483A patent/CN100415179C/zh not_active Expired - Lifetime
- 2000-06-07 US US09/589,242 patent/US7083637B1/en not_active Expired - Lifetime
- 2000-06-07 DE DE60045877T patent/DE60045877D1/de not_active Expired - Lifetime
- 2000-06-07 CA CA002376282A patent/CA2376282C/en not_active Expired - Lifetime
- 2000-06-07 EP EP00939591A patent/EP1581162B1/en not_active Expired - Lifetime
- 2000-06-07 WO PCT/US2000/015518 patent/WO2000074633A2/en active Application Filing
- 2000-06-07 KR KR1020017015867A patent/KR100684489B1/ko active IP Right Grant
- 2000-06-07 DK DK00939591.4T patent/DK1581162T3/da active
- 2000-06-07 AU AU54659/00A patent/AU769863B2/en not_active Expired
- 2000-06-07 JP JP2001501170A patent/JP4290363B2/ja not_active Expired - Lifetime
- 2000-06-07 AT AT00939591T patent/ATE506021T1/de active
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2005
- 2005-11-08 US US11/270,247 patent/US7547316B2/en not_active Expired - Lifetime
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101528155B (zh) * | 2006-10-18 | 2011-12-07 | 科洛普拉斯特公司 | 用于治疗失禁的植入式装置及其使用方法 |
CN101795640A (zh) * | 2007-07-16 | 2010-08-04 | Ams研究公司 | 用于治疗骨盆病况的手术装置和方法 |
CN101795640B (zh) * | 2007-07-16 | 2013-08-07 | Ams研究公司 | 用于治疗骨盆病况的手术装置 |
CN101801281B (zh) * | 2007-07-27 | 2013-03-06 | Ams研究公司 | 骨盆底治疗以及相关的工具和植入物 |
CN101917928A (zh) * | 2008-01-22 | 2010-12-15 | 克劳德·吉洪 | 部分套囊 |
CN101917928B (zh) * | 2008-01-22 | 2013-11-27 | 克劳德·吉洪 | 部分套囊 |
Also Published As
Publication number | Publication date |
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US7547316B2 (en) | 2009-06-16 |
AU769863B2 (en) | 2004-02-05 |
ATE506021T1 (de) | 2011-05-15 |
AU5465900A (en) | 2000-12-28 |
JP2004500152A (ja) | 2004-01-08 |
EP1581162A2 (en) | 2005-10-05 |
KR100684489B1 (ko) | 2007-02-22 |
JP4290363B2 (ja) | 2009-07-01 |
US20060058574A1 (en) | 2006-03-16 |
DE60045877D1 (de) | 2011-06-01 |
WO2000074633A2 (en) | 2000-12-14 |
WO2000074633A3 (en) | 2008-10-02 |
CN100415179C (zh) | 2008-09-03 |
KR20020036954A (ko) | 2002-05-17 |
CA2376282A1 (en) | 2000-12-14 |
EP1581162B1 (en) | 2011-04-20 |
CA2376282C (en) | 2008-08-19 |
DK1581162T3 (da) | 2011-08-01 |
US7083637B1 (en) | 2006-08-01 |
EP1581162A4 (en) | 2009-05-27 |
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