CN1345211A - 用于输卵管堵塞的方法和装置 - Google Patents

用于输卵管堵塞的方法和装置 Download PDF

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CN1345211A
CN1345211A CN00805761A CN00805761A CN1345211A CN 1345211 A CN1345211 A CN 1345211A CN 00805761 A CN00805761 A CN 00805761A CN 00805761 A CN00805761 A CN 00805761A CN 1345211 A CN1345211 A CN 1345211A
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道格拉斯·C·哈林顿
维多利亚·E·卡尔-布伦德尔
布雷特·S·鲍曼
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Abstract

本发明涉及用于妇女输卵管堵塞的方法和装置。该方法包括用相对低的功率热损伤子宫输卵管连接的内层,接着放置网状泡沫栓(34)。在一个实施方案中,血管化组织(36)生长入栓,并且防止或阻碍栓周围瘢疤组织的形成。另一个具有相对小泡沫孔径的实施方案促进栓周围血管化囊(38)的形成。这种血管化囊的存在限制了患者的异物反应,以使囊在栓周围不收缩。本发明还涉及为损伤子宫输卵管连接的上皮层而设计的导管(51),以及使用该导管在子宫输卵管连接形成长而窄的损伤的方法。

Description

用于输卵管堵塞的方法和装置
发明领域
本发明涉及用于机体导管如子宫输卵管连接、子宫峡,以及输卵管的永久性堵塞的装置和方法。特别地,本发明涉及妇女绝育的相对简单的手术过程,其可在医师办公室中进行。
发明背景
妇女输卵管永久性堵塞经常因医学原因而期望或需要。目前提出的堵塞输卵管而实现绝育的过程包括手术结扎、通过异物插入而堵塞,以及通过严重损伤引起的瘢疤而堵塞。
妇女绝育的一种方法是手术输卵管结扎,其是输卵管被结扎并切断的过程,或者被用通过腹壁切口进入盆腔的器械夹紧或融合。当用内窥镜进行时,盆腔必须用惰性气体充气膨胀。用剖腹术进行的输卵管结扎需要在全身麻醉下进行腹部6至12厘米长的手术切口。目前,当输卵管从管外部被夹紧或融合时,为了确保输卵管保持堵塞,它们必须在两个或三个不同位点被夹紧或融合。
已经提出多种损伤技术。Cohen等,输卵管电结扎方法,美国专利5556396(1996年9月17日)公开了通过将电供能的电极提供给输卵管的输卵管结扎方法。电极被送进输卵管并被供能以热损伤输卵管,由此引起输卵管足够的瘢疤而将其永久性堵塞。在另一技术中,将硬化剂(奎纳克林)注射入子宫和输卵管中以产生输卵管永久性堵塞。
已经提出用于输卵管或子宫输卵管连接堵塞的多种栓。一种技术包括将可固化的高弹体组合物如硅酮经宫颈注射到输卵管中,注射的量足以填充输卵管邻近子宫的部分。使高弹体组合物固化,从而非手术阻塞输卵管。Erb,用于女性非手术可逆绝育的方法和装置,美国专利3805767(1974年4月23日)。其他人提出在输卵管中放置堵塞线或圈来堵塞它们。Ton,具有机械释放机理的内腔圈转运系统,美国专利5601600(1997年2月11日),提出经过峡在输卵管深部放置Guglielmi可摘下的圈(通常用于血管堵塞)。圈必须与从子宫延伸到输卵管中的释放导管一起被放入输卵管中。
几篇文献建议输卵管被损伤以在瘢疤点将导管融合或提高栓的固位。例如,Vancaillie,经子宫的绝育装置和方法,美国专利5095917(1992年3月17日)讲授了在输卵管中形成瘢疤而堵塞输卵管的方法,其包括对输卵管使用化学瘢疤剂(盐酸四环素)或使用高频电流。其目的是引起速发型炎性反应,包括水肿、白血细胞的到达、成纤维细胞和结缔组织的增生、巨嗜细胞的到达,以及引起随后的愈合过程,其导致在损伤区瘢疤组织的形成。Lessen,手术方法和所用的电极,美国专利3858586(1975年1月7日)讲授了使用射频能的输卵管瘢疤化,而不用在之后放置栓,它基于生成的瘢疤将足以密封输卵管的理论。用于引发在口/峡/输卵管中损伤的损伤类型和栓材料的性质均决定发生的损伤愈合反应的类型。如果使用高功率产生损伤,机体的生物学反应将是典型炎性反应并导致瘢疤组织的生成。
如果栓材料具有引起对材料异物反应的结构、化学和/或孔径(例如光滑、非多孔材料),这将促进瘢疤组织和栓周围纤维囊的形成。异物反应主要由成纤维细胞吸引到该区(如果可能的话,包括成纤维细胞潜入栓材料)和具有少许血管结构的结缔基质的形成组成。异物反应也被描述为“瘢疤”形成。组成异物反应的细胞可以分化为成肌纤维细胞,其能够在该材料周围收缩并引起材料变形或破碎,或在输卵管中驱除植入物。成肌纤维细胞收缩、管蠕动、管收缩,以及纤毛上皮的组合产生能从管中驱除该材料的组合力。
如果栓被插入输卵管而没有伴随上皮细胞内层的破裂,通常导致栓的驱除。输卵管的上皮内层发挥保护下层不被外来物质和感染剂浸润和感染的作用。以同样方式,少数细胞将穿过上皮内层进入栓所处的输卵管腔。这样,在无损伤的输卵管中植入栓引起很少的,如果有的话,浸润到栓材料。作为代替,可能未浸润的大孔栓将成为输卵管内脱落的坏死碎片的受器。这可能导致栓基质的更高污染和感染。另外,向内生长的缺乏将导致栓基质的较弱的锚定作用,所以在输卵管中存在的驱除力能够驱除和逐出栓。因此完整上皮层的保留是不期望的,上皮细胞层必须被破坏或破裂以消除浸润细胞的物理屏障。在这发生后,多孔材料可被放入到裸露区,接着可发生损伤愈合反应。将多孔材料植入到具有完整上皮内层的输卵管中不允许向内生长入材料中,因为上皮细胞内层的部分功能是作为感染剂和细胞浸润的物理屏障。
我们的在先专利申请,Harrington等,输卵管堵塞的方法和装量,美国专利申请09/063119,(1998年5月20日提交)(该文献引入本文作参考)阐明了通过在通向输卵管的子宫口或角中放置栓而阻塞输卵管的方法。我们的在先申请中讨论的示例性实施方案是使用热来损伤口组织并在口中放置栓,其通过由热损伤引起的口炎症而被固定在口中。所提出的栓含有发泡材料,它允许组织向内生长入栓中。
概述
下面描述的方法和装置为妇女输卵管堵塞而提供。该方法包括用相对低功率的能量热损伤子宫输卵管连接的内层,接着放置网状泡沫栓。施加于子宫输卵管连接口内层的功率被限制以避免热损伤该区的深层组织,但彻底损伤表层组织。将具有合适弹性、结构和泡沫孔径的栓放置在轻度损伤的子宫输卵管连接促进愈合组织生长入栓。生长入栓的组织以正常程度血管化,并且在截面呈现为“器官样”物质。健康的血管化组织向内生长入栓防止或阻碍栓周围瘢疤组织的形成。这使栓排出的可能性最小化,并且也使上皮组织在子宫输卵管连接的损伤部位的期望的再生长继续到堵塞的成瘘发生的位点的可能性最小化。
在另一实施方案中,栓包含具有合适弹性、结构和不促进血管化组织向内生长的相对小的泡沫孔径的泡沫。这种栓被植入轻度损伤的子宫输卵管连接并促进栓周围血管化囊的形成。这种血管化囊的存在限制了病人的异物反应,因此囊不在栓周围收缩。虽然巨嗜细胞将很有可能浸润栓,但是没有显著的向内生长发生。
还存在的是为损伤子宫输卵管连接上皮层而设计的导管,以及用导管在子宫输卵管连接中形成长而窄的损伤的方法。
附图的简要说明
图1是女性生殖系统的部分视图。
图2是女性生殖系统的子宫输卵管连接的横截面。
图3和图3a阐明了用堵塞栓堵塞输卵管的已有技术。
图4和图4a是在适当位置具有器官样栓的女性生殖系统的子宫输卵管连接的横截面。
图4b和图4c阐明了在适当位置具有器官样栓的损伤组织边界反应。
图5是用于运输射频能的装置和用于子宫输卵管连接的堵塞栓的图。
图5a和图5b显示了在图5中阐明的装置的横截面。
图6和图6a是用于绝育过程的栓材料的显微图。
图7和图8是用于绝育过程的栓材料的显微图。
图9和图9a阐明了放置和部分愈合后的栓组成。
图10阐明了放置和部分愈合后的栓组成。
发明的详细描述
图1显示了女性生殖系统的一些主要单元。子宫2是具有梨形状的女性骨盆器官。它含有厚肌层、子宫肌层3、具有称为子宫内膜4的可变厚度内粘膜层的腔,以及被称为子宫腔5的腔。子宫颈6定义子宫颈管7,它是通向阴道8的下开口。输卵管(或壶腹)9是中空器官,它将子宫连接到卵巢10。卵巢15是在女性生殖时期的每个周期中产生一个或多个卵的器官。在人体女性生殖系统中,有一个子宫、两个输卵管和两个卵巢(正常情况下)。输卵管和子宫连接的位点被称为子宫输卵管连接11。它是约10毫米长的管状部分。在静止(resting)部位它的内径小于1毫米,但是当气体或液体通过子宫和输卵管时,子宫输卵管连接的直径可以扩张到约2毫米。子宫输卵管连接提供了子宫和输卵管间的过渡,从子宫腔到子宫输卵管连接腔的过渡区被称为口或角(以序号12标记)。在口和输卵管峡13之间的过渡区被称为间质部(标记为14)。口、子宫输卵管连接、间质部、峡和输卵管是由卵巢至子宫的通路的一部分,该通路有时被称为输卵管。为清楚起见,我们引入术语卵巢通路(ovarian pathway)来指代当卵细胞从卵巢转移到子宫腔时所经过的整个通路。
图2显示了子宫输卵管连接11,它包括口12、峡13,以及间质部14。其横截面显示了组成子宫输卵管连接的组织层。腔20穿过输卵管,并且该腔内衬有一层由上皮21和固有层23组成的粘膜组织。在输卵管内,这层粘膜组织被称为输卵管内膜,表示为序号22。在上皮层下面的组织层是固有层,表示为序号23。固有层被由纵肌层25包围的环肌层24所包围。纵肌层可以被第二环肌层包围。第一环肌层24一般含有约10-14层肌细胞。新治疗方法的一个方面是在插入堵塞栓前这些层的每层的损伤程度。
图3阐明了根据几种老方法在输卵管峡13内放置的植入栓30。(栓也已被提出在输卵管深部,和口12内植入。Sinnreich,输卵管堵塞装置,美国专利3918431(1975年11月11日)显示了用于暂时性女性绝育的口栓。)上皮层21保持完整,并且在为栓所堵塞的区位于口/峡/输卵管腔之上连续。一些人曾建议上皮层21和/或输卵管内膜22将在栓的近侧面和远侧面31d和31p(纵向面)上生长。上皮层将及时再通输卵管并在栓上形成瘢疤组织,从而导致在许多被治疗的病人中栓周围瘘的形成。Zeluff,美国专利4606336建议在口上(而不在口的腔内)使用泡沫环,这依赖于成纤维细胞向内生长入环从而将其封至口上。然而,该装置很可能经受子宫异物反应,导致异常子宫出血、增加的子宫肌层和输卵管收缩和早产。
图3a阐明了当使用已有技术时发生的输卵管各层的损伤,该技术建议部分切除输卵管,接着放置栓(已有技术方法并不建议在子宫输卵管连接部分切除)。当使用射频功率时,所施加的功率足以损伤输卵管的整个厚度,包括环肌层24和纵肌层25。这导致“标准异物反应”,其是在科学家中被理解为包括炎症、包囊和最终的瘢疤形成的术语。瘢疤组织32将在损伤组织中形成(导致输卵管结构的根本变化),并且如果向内生长可能的话,它也可在栓内形成。当栓被留在输卵管中时,无血管的纤维变形囊33可在栓周围形成以保护主体不受栓的侵害。这样,栓最终被瘢疤组织和纤维变形囊所包围,如图3a所示。异物反应的生物学方法将接着起作用来驱除栓。机体也可能趋于代替瘢疤组织而生长上皮/输卵管内膜细胞,由此生成包围栓的瘘管,这导致精子通过和卵受精。受精卵可能不能通过瘘管移动到子宫内,其在输卵管中捕获受精卵导致宫外孕。
图4阐明了子宫输卵管连接中各层的损伤程度,以及在组织和插入的用以引起输卵管堵塞的泡沫栓之间所期望的相互作用。泡沫栓34被插入到靶位以堵塞,该靶位在本说明中是子宫输卵管连接。栓在靶位通过施加热能处理后被放在适当的位置。热能在远低于引起严重烧伤(和伴随的严重炎性反应)所需的水平下被运输,但它足以引起上皮层21和固有层23的热坏死。热死(坏死)区被表示为序号35,并沿着通路延伸约4至10毫米长。对环肌24的损伤是可接受的,但是对纵肌层25的损伤是不期望的。这导致栓周围子宫输卵管连接的最小的破坏。肌体以正常“损伤愈合反应”而反应。术语“损伤愈合反应”是在本领域中被理解为包括生物学活动的术语,所述生物学活动包括:(1)白细胞、嗜中性粒细胞、单核细胞的到达和它们转化成巨噬细胞并凝集成巨细胞,以及成纤维细胞的到达,(统称为炎性细胞),和(2)细胞外基质的生成和蛋白质的沉积,和(3)在损伤部位肉芽和结缔组织的形成。
损伤愈合反应可以在周围完整通路持续到完成,并将进一步经历肉芽组织再机化成相应于原损伤组织的特化的功能组织(与原组织的结构相吻合),以及瘢疤组织的形成(与组织原结构不同)。栓周围的组织立即反应依赖于栓的组成、孔径和结构。对于光滑的栓,反应将如上面有关图3和图3a的讨论而发生。对于下面描述的栓,立即包围栓和/或在栓内向内生长的组织的短期和长期状况依赖于栓孔径和结构。当相对于细胞大小,孔径大,在40-200微米范围内,并具有特定结构时,机体将通过在泡沫的孔中形成血管化组织而愈合。炎性细胞将进入泡沫孔中,吸引其它细胞,形成细胞外基质和结缔组织,并在泡沫的孔内形成被称为肉芽组织的组织集合体。随后的愈合包括血管结构如小动脉、毛细血管和淋巴管的向内生长入居于泡沫的孔内的结缔组织。由于泡沫的独特结构和孔径,肉芽组织将作为肉芽组织长期保留。这样在体内以其最终形式存在的大孔栓将包含泡沫超结构的大量丝,其形成肉芽组织占据孔的相互连通的孔网络。栓还包含大量在肉芽组织中形成的血管,因此分散入原栓材料的组织可被描述为血管化有机组织。血管化组织被血管化到与肌体内其它天然组织常规血管化程度相同的程度。
当栓与细胞尺寸相比,孔径小,在1-20微米范围内时,在栓小间隙中将不形成血管化肉芽组织。随后的愈合包括高度血管化异体囊的形成和一些巨噬细胞入侵栓孔中,而没有其它细胞或与愈合的后阶段相关的组织(如细胞外基质、肉芽组织和血管)入侵。作为替代,机体将紧靠栓形成具有血管的血管化囊,它位于泡沫附近并在距泡沫约10微米以内。这可被称为改变的异物反应。
图4a阐明了在损伤愈合过程进行到栓连续存在所允许的程度后栓和卵巢通路的状况。通路靶位的几层已愈合以在栓周围和整个损伤通路形成愈合肉芽组织。直接将栓放置到损伤通路内表面促进该组织包围栓,并防止在栓纵向表面周围形成上皮。上皮26已生长而覆盖栓的远侧面和近侧面,从而在栓上形成组织的远侧层和近侧层。未损伤的纵肌层和剩余的环肌层保持损伤前的状况。一段时间后,新血管网络在肉芽组织内形成,且结缔组织基质在肉芽组织内形成。图4b阐明了在损伤愈合过程进行到栓连续存在所允许的程度后大孔栓和卵巢通路的状况。通路靶位的几层已愈合以在栓周围和整个损伤通路形成愈合肉芽组织。将栓直接放置到损伤后的通路的损伤内表面促进该组织包围栓,并促进愈合组织穿透入栓(并因此抑制在栓纵向表面周围形成上皮)。大量血管36已进入大孔内或在大孔内形成。包括大量巨噬细胞37的损伤愈合组织的在先进入已抑制栓周围纤维囊的形成和在栓和卵巢通路的损伤部分间的上皮入侵。机体显示出识别栓为器官,并放弃另外的损伤愈合和异物反应。图4c阐明了在损伤愈合过程进行到栓连续存在所允许的程度后小孔栓和卵巢通路的状况。通路靶位的几层已愈合以在栓周围和整个损伤通路形成愈合肉芽组织。将栓直接放置到损伤后的通路的损伤的内表面促进该组织包围栓,并防止在栓纵向表面周围形成上皮。分散的巨噬细胞37已进入小孔中,并且在栓周围已形成血管化改变的异体囊38。血管化异体囊包括大量血管,并且异物反应的进一步进展被抑制。上皮已生长到覆盖栓的远侧面和近侧面,从而在栓上形成组织的远侧层和近侧层。
因此,根据栓泡沫的孔径,栓可被血管化肉芽组织浸润(对于具有40-200微米范围内的大孔径的栓)或被分散的巨噬细胞浸润并被结缔组织的血管化囊包围(对于具有1-20微米范围内的小孔径的栓)。在任一种情况下,上皮在栓和卵巢通路损伤部分间的生长均被抑制,且异体无血管纤维囊的形成通过有利于其它损伤愈合结构的那种结构的取代而被抑制。
栓优选由具有实际上促进细胞向内生长入材料(大孔栓)中或允许巨噬细胞浸润但抑制细胞向内生长(小孔栓)的孔径、化学和结构的材料制成。对于大孔栓,所期望的向内生长的性质与标准异物反应非常不同。主要的差别是一类由多种血管、结缔基质和细胞、巨噬细胞,以及其它细胞组成的向内生长。对于小孔栓,异体囊的性质被改变成包括大量血管。这些结构可被描述为“类器官”,因为它们以器官的完整部分存在。我们研究的两类材料在愈合后已表现出这种类器官外观,即那些具有特定结构和在40-200微米间的孔径的材料,和那些具有特定结构且是多孔的(1-20微米)材料。损伤愈合生长将被组织学分类成,对于小孔材料为类似于“改变的异物反应”的组织,和对于大孔材料为接近“真皮”的外观和内容。
栓可由ePTFE(也被称为膨胀的特氟纶或膨胀的聚四氟乙烯),多孔硅酮、丙烯酸共聚物、醋酸纤维素、聚乙烯和高密度聚乙烯(HDPE)、PE、聚酯,以及烧结的,微滚花的,或模制的钛和铂制成。构造成的(textured)聚酰胺或聚酰亚胺、羟基磷灰石,以及水凝胶也是有潜力的合适材料。这些材料优选形成泡沫材料的栓(球体、圆柱体或其它堵塞物质)。泡沫的优选孔径在上述两个清楚的范围内,也就是1-20微米孔径和40-200微米孔径(40-200微米孔径更好)。泡沫优选形成网状泡沫,这意味着孔互相连通,而不是在材料内以离散和孤立的空隙存在。栓可以具有由泡沫或具有孔的网状网络多孔材料包围的固体孔。
硅酮泡沫易于形成泡沫栓,其过程在Seare,制作多孔装置的方法,美国专利5605693(1997年2月25日)中提出。未固化的硅酮(由Nusil技术公司提供的MED 4860是合适的)被注射入填有颗粒的模中,并缓慢填充到所有颗粒间的空隙中。硅酮固化并且颗粒溶解在合适的溶剂(水,其中使用了糖或盐)中以形成网状泡沫栓。泡沫栓具有在20-100 Shore A的硬度值,优选为约60 Shore A。
图6和图6a阐明了大孔泡沫栓的两个实例。泡沫是硅酮45(只有少许被用序号标出)咬合角块(interlocking angular block)的基质,它们一起形成相互连通的孔网络46,其大小相应于用于制作底片的颗粒的大小。孔与周围孔相互连通形成网状或网络泡沫。在图6和图6a中阐明的大泡沫孔的孔径在40-200微米(mu)范围内,图6a中泡沫孔径小于图6中的孔径。小孔泡沫结构与图6基本相同,除了其孔径在1-20微米范围内以外。
栓可由一般被称为ePTFE的膨胀聚四氟乙烯用通常用于形成ePTFE的方法制成。从PTFE棒开始,该棒被拉伸来膨胀PTFE从而形成ePTFE的结节和原纤维特性系统。孔径(通常指结节间的距离)和连接结节的原纤维的数目和大小通过以控制的速度和温度拉伸PTFE棒来控制。(栓也可从PTFE薄片制成,这种薄片被拉伸到生成所期望的孔隙率所必需的程度,接着切割成形。栓也可从ePTFE的很薄的薄片形成,该薄片被用来涂覆或包裹PTFE的固体棒。)这一方法导致图7中所阐明的材料,它具有特征在于通过原纤维在结节间运动和垂直延伸至节结纵向的原纤维48相互连接的纵向结节47的微结构。在结节间测定的孔径对大孔泡沫来说在40至200微米范围内,对小孔泡沫来说在1至10微米间。
栓也可由丙烯酸共聚物(如四氟乙烯和六氟丙烯)形成,如图8所示。丙烯酸共聚物被形成为咬合纤维49团,它在泡沫的外表面上成为向外伸展的棒50。在棒间测得的距离的孔径优选在1至10微米范围内。
用于转移栓并应用于期望的损伤系统的转移导管在图5中得到阐明。图5阐明了实施方案,其中损伤能量源是射频能。导管包括具有损伤段52的导管体51,该损伤段包含在导管远侧端53内滑动设置的管状延伸。导管体的远侧端延伸到管状延伸的近侧端,其短长度为2-25毫米,这在使用中足以稳固地固定管状延伸。四个电极54、55、56和57沿着损伤段的外表面排列。一个或多个温度传感器58装在损伤段上(单一温度传感器可装在损伤段中心,在接地电极之间)。远侧端和损伤段外径约55密耳。在射频实施方案中损伤段约6至8毫米长,电极是环电极,它约0.037至0.050英寸宽(沿着导管纵轴测定),并且它包裹在导管周围。一个或多个泡沫栓34被储备在导管体内,并且显示封装于损伤段内。通过在损伤段的远侧端和近侧端与通电电极或热电极54和57一起排列电极,且接地电极55和56位于热电极间,当电极适当通电时,在卵巢通路中可产生长而窄的损伤。通电电极位于接地电极间,接地电极位于损伤段的远侧端和近侧端的相反模式也可被用于产生所期望的长而窄的损伤。
栓可被压缩以适应导管损伤段的腔59。支撑棒60被安置于导管体51中,在导管体内损伤段远侧任一点上被纵向固定(它可通过将支撑棒近侧段粘合或热封到导管体的内壁而被固定)这允许损伤段的适当拉回以释放栓。拉线61通过止挡62在拉线远侧端的连接被固定于损伤段的近侧端。拉线从损伤段远侧延伸到导管体近侧端。图5a显示了装置沿截面5a的横截面,更清楚地阐明了拉线止挡固定于损伤段52内壁上的相对位置,它自身被滑动放置在导管体51的远侧端53内,并也滑动放置在支撑棒60周围。图5b显示了装置沿横截面5b的横截面,更清楚地阐明了支撑棒60在导管体51内的位置。拉线61可从导管的近侧端手动操作以在导管体内将损伤段拉向近侧。当损伤段被拉近时,支撑棒60将栓(或多个栓)固位在卵巢通路内适当位置,这样在初始定位后从导管远侧端驱除栓而相对于卵巢通路的损伤段不移动它们(并且相对于患者不移动导管体)。给电极提供射频功率的电线可沿着拉线穿过导管体的腔,或者它们可以被封装在导管体内,在导管近侧端上提供电接插件63以将导管中的电线连接于射频电源。电线也可合并入拉线,到射频电源上的电连接被置于拉线的近侧端。可以采用其它损伤机理,包括电阻性加热元件、直接激光辐射、激光加热元件、微波、超声、peizo-电擦伤、降温、冷冻、化学消融术,以及机械性与物理性擦伤。
在使用中,导管被经宫颈(transcervally)插入到子宫中,并且导管远侧端进入输卵管,直到损伤段在沿卵巢通路所期望的点上放置(子宫输卵管连接是我们优选的损伤和栓放置位置)。外科医生可用内窥镜或宫腔镜看见放置,和/或在通路内的放置可用荧光屏被证实。(当然,导管放置可盲完成,仅使用触觉反馈。)一旦损伤元件在合适位置,适当的损伤可通过施加限于破坏栓放置区中的上皮层/输卵管内膜的功率来产生,而避免不期望的生理反应。目的是彻底使上皮/输卵管内膜坏死,为了完成这一目的,外科医生施加足够的损伤功率以使上皮/输卵管内膜,以及固有层坏死,同时限制损伤功率以防止损伤纵肌层。对环肌层的损伤应是弱的,但是是允许的。在损伤卵巢通路后,损伤段可通过将拉线拉近而撤回,而保持导管在原位。在操作者将导管定位以应用后,这驱除栓而不需要栓和损伤间的相对运动。
当使用射频能作为损伤机理时,我们已确定0.1至5瓦特的功率约5至60秒引起上皮层的热坏死,而不损伤纵肌层,且不诱导急性炎性反应。优选地,在组织中温度通过装在转移导管损伤段上的温度传感器得到监控,施加功率以将组织温度在40-80℃维持5-60秒。通过实验,我们已确定温度在约70℃维持7秒钟作用好。另外,温度在52-58℃的范围内维持40-60作用也好。加热也可在两个阶段中完成,简短加热到70-80℃(5至10秒钟),接着再加热到40-60℃维持30至60秒钟。
图9和图9a是大孔泡沫实际植入物的照片。图9显示植入后几周卵巢通路弯曲区段的横截面,它包括与周围损伤卵巢通路组织相连的大孔栓,以及卵巢通路未损伤部分的视图。在该图解中栓的硅酮基是序号45所示的灰白色不规则物质。包围在损伤卵巢通路组织65周围的向内生长组织64和未损伤卵巢组织已被染色来辅助鉴定存在的结构。在图9中可见的卵巢通路组织包括损伤的和愈合的固有层67、损伤的和愈合的肌层68,以及未损伤的纵肌层69(环肌层和纵肌层在该照片中不能容易地被区分,它们位于序号70所示的区)。上皮/输卵管内膜层不存在,它们已被损伤方法所破坏(虽然上皮层71在未损伤组织66中可见)。其它可见结构包括浆膜72、未损伤组织66中卵巢通路的襞(褶)73。在栓内损伤愈合组织64的细节在更高放大倍数视图图9a中是可见的,图9a是图9中区74的放大。硅酮45的单个颗粒在硅酮泡沫基中是可见的。在孔46内,损伤愈合组织64已生长入肉芽组织的结构中,典型的单核细胞75、巨噬细胞37和几根血管36(在血管壁中含有可见内皮细胞83,在血管腔内含有可见红细胞82)是可见的。细胞外基质76也填充了许多孔体积。
血管化纤维变性囊的形成在图10中得到阐明,图10是包含双层膜77的栓的照片,膜77包含小孔ePTFE、光滑膜ePTFE和周围卵巢通路组织。栓实际上是两面的,在右面具有带5微米孔ePTFE的小孔面78,在左面具有带0.45微米孔ePTFE的基本上光滑的面79。图10显示了在植入几周后该与周围卵巢通路组织相连的两面栓的横截面。在图10中,在栓周围的愈合固有层67、损伤的和愈合的环肌层68,以及未损伤的纵肌69在该近视图中是看不见的。在栓小孔面上,生成了血管化异体囊38。在血管化改变的异体囊38中形成的血管81被发现紧靠栓(在血管内可看到单个红细胞82)。其它可见结构包括细胞外基质76、分散的巨噬细胞37、单核白细胞75和巨细胞83。在栓光滑面,可见异物反应的特征无血管纤维变性囊33。无血管纤维变性囊完全由细胞外基质76和贯穿细胞外基质的分散的成纤维细胞84组成。在无血管纤维变性囊中没有血管形成,一个明显的现象是栓光滑面被异物反应分隔。(白色空间85是当栓周围组织组织学倾斜时,在所产生的各结构间仅有的分隔。)
当装置和方法的优选实施方案参照它们所在环境被描述时,他们仅仅是说明本发明的原理。可以开发用于所描述的本发明的其它材料,可以开发用于所描述的本发明的其它损伤卵巢通路的方法,它们都是涵盖于本发明的。在不背离本发明的实质和所附 书的范围的前提下,可以设计其它实施方案和结构。

Claims (15)

1.植入人体的装置,所述装置包含:
包含耐用的生物学可允许的且生物学惰性的材料的网状泡沫的泡沫栓;
所述泡沫栓包括大量孔;
充分填充泡沫栓孔的血管化机体组织。
2.权利要求1的装置,其中泡沫栓的孔径在40至200微米之间。
3.用于固位在女性机体卵巢通路内的栓,所述栓包含大量泡沫超结构的丝,它们形成相互连通的孔网络,肉芽组织占据这些孔。
4.用于固位在女性机体卵巢通路内的栓,所述栓包含大量泡沫超结构的丝,它们形成相互连通的孔网络,血管化组织占据这些孔。
5.堵塞女性机体卵巢通路的方法,所述方法包括以下步骤:
将损伤元件应用于通路的区段,并操作损伤元件以在该通路区段中引起损伤;
限制由损伤元件产生的损伤的严重程度以避免在愈合后形成瘢疤组织;
将包含网状泡沫的泡沫栓安装入通路的损伤区段;
使通路的损伤区段与安装的泡沫栓愈合。
6.堵塞女性机体卵巢通路的方法,其中卵巢通路在卵巢通路内表面衬有上皮层,固有层位于上皮层下面,环肌层位于固有层下面,纵肌组织层位于环肌组织下面,所述方法包括以下步骤:
将损伤元件应用于通路的靶区段,并操作损伤元件以在通路区段中引起使上皮层坏死的损伤;
限制由损伤元件产生的损伤的严重程度以避免纵肌层坏死;
将包含网状泡沫的泡沫栓安装入通路的损伤区段;
使通路的损伤区段与安装的泡沫栓愈合。
7.权利要求6的方法,进一步包括:
以安装有导管的射频电极阵列的形式提供损伤元件;
通过将射频电极阵列插入到卵巢通路中直到射频电极阵列与通路靶区段接触而将损伤元件应用于通路的靶区段;
通过射频电极阵列给卵巢通路施加射频能而限制损伤的严重程度,并且限制射频能从而避免纵肌层的坏死。
8.权利要求7的方法,其中施加于卵巢通路的射频能被限制在0.1至5瓦特的范围内,施加的时间为5至60秒。
9.权利要求7的方法,其中施加于卵巢通路的射频能被控制以将卵巢通路的温度在52-58℃的范围内维持40-60秒。
10.权利要求7的方法,其中施加于卵巢通路的射频能被控制以将卵巢通路的温度在约70℃维持约7秒。
11.权利要求6的方法,进一步包括以下步骤:
以安装有导管的加热元件和安装有导管的位于导管上与加热元件靠近的温度传感器的形式提供损伤元件;
通过将加热元件和温度传感器插入到卵巢通路中直到加热元件和温度传感器与通路靶区段接触而将损伤元件应用于通路的靶区段;
通过加热元件向卵巢通路施加热而限制损伤的严重程度,并且通过控制加热元件将卵巢通路加热到由温度传感器感受到的温度为40-80℃,持续时间为5至60秒,而限制损伤的严重程度。
12.权利要求5的方法,进一步包括以下步骤:
提供包含孔径在40-200微米范围内的网状泡沫的泡沫栓。
13.权利要求5的方法,进一步包括以下步骤:
提供包含孔径在1-20微米范围内的网状泡沫的泡沫栓。
14.权利要求6的方法,进一步包括以下步骤:
提供包含孔径在40-200微米范围内的网状泡沫的泡沫栓。
15.权利要求6的方法,进一步包括以下步骤:
提供包含孔径在1-20微米范围内的网状泡沫的泡沫栓。
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CN100360098C (zh) 2008-01-09
US8226645B2 (en) 2012-07-24
US7842035B2 (en) 2010-11-30
AU2739800A (en) 2000-08-18
US20010016738A1 (en) 2001-08-23
HK1039270B (zh) 2011-03-25
US6309384B1 (en) 2001-10-30
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EP1156764A1 (en) 2001-11-28
US20110040146A1 (en) 2011-02-17
DE60044237D1 (de) 2010-06-02
WO2000044323A1 (en) 2000-08-03
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EP2191797A1 (en) 2010-06-02
AU2004200772A1 (en) 2004-03-25
ATE464868T1 (de) 2010-05-15
AU767864B2 (en) 2003-11-27
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