CN103889340B - 自固位式可变套环缝合线 - Google Patents
自固位式可变套环缝合线 Download PDFInfo
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- CN103889340B CN103889340B CN201280025020.3A CN201280025020A CN103889340B CN 103889340 B CN103889340 B CN 103889340B CN 201280025020 A CN201280025020 A CN 201280025020A CN 103889340 B CN103889340 B CN 103889340B
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Abstract
本发明提供一种缝合线，所述缝合线具有：用于穿透组织的第一端部；具有周边的细长缝合线主体；位于所述周边上的多个固位体；以及包括具有可变周长的可变套环的第二端部，其中所述可变套环包括固定套环，所述固定套环滑动地接合所述细长主体，用于滑动地改变所述可变套环的周长，并且其中所述第一端部可穿过所述可变套环以作为锚定件来固定组织，所述锚定件防止所述缝合线沿所述第一端部的部署方向运动。
Description
相关专利申请的交叉引用
本专利申请根据35U.S.C.§119(e)要求于2011年3月23日提交的美国临时专利申请号61/466,924的权益，该专利申请全文以引用的方式并入本文。
技术领域
本发明一般涉及缝合线(包括自固位缝合线和单向自固位缝合线)、制造所述缝合线的方法、及其在伤口修复和外科手术中的使用。
背景技术
诸如缝合线、缝钉和平头钉之类的伤口闭合装置已广泛用于人体和动物的表浅和深部外科手术中，以用于闭合伤口、修复跌打损伤或缺损、将组织接合在一起(使已切断组织拉近、闭合解剖空间、将单个或多个组织层附连在一起、在两个中空/管腔结构之间形成吻合、毗连组织、将组织附接或重新附接至其适当的解剖位置)、将外来元件附接至组织(附连医疗植入物、装置、假体和其它功能性或支承性装置)、以及将组织重新定位到新解剖位置(修复、组织抬升、组织移植和相关手术)等等。
缝合线通常用作伤口闭合装置。缝合线通常由附接至具有尖点的针的丝状缝合线组成。缝合线可由广泛的多种材料制成，包括可生物吸收性(随时间推移在体内完全分解)或不可吸收性(永久性、非可降解性)材料。已经发现的是，吸收性缝合线尤其可用于下述情况中：拆线可危害修复或者在伤口愈合已完成之后自然愈合过程使得由缝合线材料提供的支承成为非必须的；如(例如)在完成不复杂的皮肤缝合中。非降解性(非吸收性)缝合线用于下述伤口中：愈合可预期会扩张或者缝合线材料需要为伤口提供长时间的物理支承；如在(例如)深部组织修复、高张力伤口、多种整形外科修复、和一些类型的外科吻合中。另外，可获得多种外科用针；针主体的形状和尺寸以及针末端的构型通常是基于特定应用的需要进行选择的。
使用普通的缝合线，将缝合针在伤口的一个侧面上推进以穿过期望的组织然后穿过伤口的相邻侧面。接着使缝合线的端部相互接近，然后例如通过在缝合线中打结而将缝合线端部保持在一起，以保持闭合的伤口。打结会花费时间并会引起一系列并发症，包括但不限于(i)刺穿，(在皮下闭合之后缝合线(通常为结)推动穿过皮肤的情况)，(ii)感染(细菌通常能够附接和生长在由结形成的空间中)，(iii)膨胀/成块(遗留在伤口中的大量缝合材料是构成结的部分)，(iv)滑移(结可滑动或解开)，以及(v)发炎(结充当在伤口中的大块“异物”)。与打结相关的缝合线套环可导致局部缺血(结可产生张力点，所述张力点可压缩组织并限制到达该区域的血流)并且可导致外科伤口处裂开和破裂的风险增加。打结还为劳动密集型的并且可占用在闭合外科伤口中所花费的时间中的显著百分比。额外的手术操作时间不仅对患者有害(并发症发生率随麻醉下所花费的时间而增加)，而且还增加手术的整体成本(多种外科手术据估计每分钟手术时间花费$15至$30)。
自固位缝合线(包括倒钩缝合线)不同于常规缝合线之处在于，自固位缝合线具有若干组织固位体(诸如倒钩)以用于将自固位缝合线在部署之后锚固到组织中并且抵制缝合线沿与固位体所面对的方向相反的方向运动，由此无需打结就能将相邻组织附连在一起(“无结”闭合)。具有倒钩的无结组织拉近装置先前已在例如美国专利号5,374,268中有所描述，该专利公开了具有倒钩状突出的带臂锚定件，而具有带倒钩的侧向构件的缝合线组件已在美国专利5,584,859和6,264,675中有所描述。具有沿缝合线的较大部分定位的多个倒钩的缝合线在美国专利号5,931,855(其公开了单向倒钩缝合线)和美国专利号6,241,747(其公开了双向倒钩缝合线)中有所描述。用于在缝合线上形成倒钩的方法和设备已在(例如)美国专利号6,848,152中有所描述。用于伤口闭合的自固定系统还导致更加逼近伤口边缘，均匀地将张力沿伤口的长度分布(减少可破坏或导致局部缺血的张力区域)，减少大部分保留在伤口中的缝合材料(通过消除结)以及减少刺穿(缝合材料挤出(通常为结)穿过皮肤表面)。相对于使用普通缝合线或缝钉的伤口闭合而言，这些特征中的全部据认为会减少结疤、改善美容效果、以及增加伤口强度。因此，由于自固位缝合线无需打结，则此类缝合线允许患者体验改善的临床结果，并且还节约与长期手术和后续治疗相关的时间和成本。应当指出，在整个说明书中标识的所有专利、专利申请、和专利出版物均全文以引用方式并入本文中。
自固位缝合线的下述能力为相比于普通缝合线也提供优越性的特征，即，甚至在不存在由结施加至缝合线的张力的情况下将组织锚固并保持固定。当闭合承受张力的伤口时，此优点自身以若干方式表现出来：(i)与将张力集中在离散点的有结的间断缝合线相反，自固定缝合线具有多个能将张力沿缝合线的整个长度分散的固位体(提供了数百个产生优异美容效果和减少缝合线“滑动”或“拉穿”机会的“锚固”点)；(ii)可按照均一的方式来闭合复杂的伤口几何形状(圆形、弧形、锯齿边缘)且可实现比间断式缝合线更高的精确度和准确度；(iii)自固位缝合线无需“第三只手”，而在传统的缝合和打结过程中通常需要“第三只手”来保持整个伤口上的张力(以防止在打结期间短暂释放张力时的“滑脱”)；(iv)自固位缝合线在其中在技术上难以打结的手术(例如在深部伤口或腹腔镜式/内窥镜式手术)中为优越的；以及(v)自固位缝合线可用于在最终闭合之前来拉近和保持伤口。因此，自固位缝合线在解剖学上紧密或深部的位置(例如骨盆、腹腔、和胸腔)中提供更容易的处理并且使得更易于在腹腔镜式/内窥镜式和微创手术中拉近组织；这些操作均不必通过结来固定闭合。较高的精确度允许自固位缝合线用于比利用普通缝合线可实现的更复杂的闭合(例如，具有直径失配、较大缺损、或荷包缝合的那些)。
自固位缝合线可为单向的，从而沿缝合线的长度具有沿一个方向取向的一个或多个固位体；或双向的，从而通常沿线的一部分具有沿一个方向取向的一个或多个固位体、接着在线的不同部分上具有沿另一个(通常相反的)方向取向的一个或多个固位体(如结合美国专利号5,931,855和号6,241,747中的倒钩的固位体所述)。尽管可以使用任意数量的固位体的连续或间断构型，但自固位缝合线的通用形式包括位于缝合线一端处的针，所述缝合线具有倒钩，所述倒钩具有“远离”针而突出的末端。“远离”针突出是指固位体的末端更加远离针，并且包括缝合线的缝合线部分可在针的方向上比在相反方向上更易于拉动穿过组织。各种固位体构型的例子在例如美国专利申请公开号20040060409、20040060410、20080255611和20100087855中有所描述。此外，具有高密度固位体构型的自固位缝合线在美国专利申请序列号号61/329,436中有所描述。
单向自固位缝合线及其使用已在上述各种专利公开中有所描述。具有锚定件(包括具有套环元件的锚定件)的各种单向缝合线已在例如美国专利申请公开号20050267531、20040060410、20080255611和20100063540中有所描述。
发明内容
期望在一些应用中使用单向缝合线，所述单向缝合线在其尾端处具有锚定件，所述锚定件被配置成更有效地抵抗张力，且更有效地防止缝合线在被部署于组织中时发生运动。还期望在一些应用中提供具有锚定件的单向缝合线，所述单向缝合线在部署于组织中时具有最小量的锚定件材料进入组织以及最小量的锚定件材料留在组织外。因而，希望提供改良的单向自固位缝合线，其具有增强的锚固到周围组织的能力、增强的组织固定能力、增大的最大负载以及增强的临床表现。
本发明提供改良的单向自固位缝合线，其具有增强的锚固到周围组织的能力、增强的组织固定能力、增大的最大负载以及增强的临床表现。
在本发明的一些实施例中，提供一种自固位缝合线，其具有：用于穿透组织的第一端部；具有周边细长缝合线主体；第一多个固位体，其位于所述细长主体的所述周边上并且取向至所述第一端部，在所述缝合线沿所述第一端部的部署方向穿过组织而运动期间，所述第一多个固位体朝所述缝合线主体屈曲，且抵抗所述缝合线在组织中沿与所述第一端部的部署方向基本上相反的方向运动；以及具有可变周长的可变套环第二端部。所述可变套环包括固定套环，所述固定套环滑动地接合所述细长主体，使得可通过沿所述细长主体滑动所述固定套环来改变所述可变套环的周长，且所述第一端部可穿过所述可变套环以作为锚定件来固定组织，所述锚定件防止所述缝合线沿所述第一端部的部署方向运动。
在这些实施例的一些中，所述第一多个固位体中的至少一个的构型可不同于所述第一多个固位体中的其他固位体。
在这些实施例的一些中，所述细长缝合线主体的横截面可为非圆形的。在其中所述细长缝合线主体具有非圆形横截面的一些实施例中，所述横截面可为多边形。
在这些实施例的一些中，所述第一端部适于穿透组织，而在这些实施例的其他实施例中，所述第一端部附接至针。
在这些实施例的一些中，所述缝合线可在所述固定套环与所述第一多个固位体之间在所述细长主体的所述周边的至少一些上具有表面结构，其中所述表面结构抵抗所述固定套环在所述表面特征之上滑动。在包括表面结构的一些实施例中，所述表面结构被设置在至少所述可变套环的周长中。
在具有表面结构的一些实施例中，所述表面结构可包括粗化处理、造窝、皱折、脊或其他纹理，而在其他此种实施例中，所述表面结构可包括第二多个固位体，所述第二多个固位体远离所述第一端部而定向，因此抵抗所述固定套环在其上方滑动。在这些实施例的其中表面结构包括第二多个固位体的一些实施例中，所述第二多个固位体中的至少一些的构型可不同于所述第一多个固位体的构型。
在本发明的一些实施例中，所述固定套环具有内部横向长度，所述内部横向长度至少大约与缝合线横截面的横向长度相同，且可为缝合线横截面横向长度的至多十倍。在这些实施例的一些中，固定套环的内部横向长度可为缝合线横截面的横向长度的至多四倍，而在这些实施例的其他实施例中，其可为缝合线横截面的横向长度的至多三倍。在这些实施例的其他实施例中，固定套环的内部横向长度可为缝合线横截面的横向长度的大约1.5倍至缝合线横截面的横向长度的大约十倍，而在其他实施例中，其可为缝合线横截面的横向长度的大约1.5倍至缝合线横截面的横向长度的大约四倍。在其他实施例中，其可为缝合线横截面的横向长度的大约两倍至缝合线横截面的横向长度的大约三倍。
在本发明的一些实施例中，所述固定套环可包括抓紧接合元件或视觉或触觉标记。
在本发明的一些实施例中，提供一种自固位缝合线，其具有：用于穿透组织的第一端部；具有周边和横截面的细长缝合线主体，所述横截面具有横向长度；第一多个固位体，其位于所述细长主体的所述周边上并且取向至所述第一端部，所述第一多个固位体在缝合线沿所述第一端部的部署方向运动穿过组织期间朝缝合线主体屈曲，且抵抗缝合线在组织中沿与第一端部的部署方向基本上相反的方向运动；具有可变周长的可变套环的第二端部。所述可变套环包括固定套环，所述固定套环滑动地接合所述细长主体，使得可通过沿所述细长主体滑动所述固定套环来改变所述可变套环的周长，且所述第一端部可穿过所述可变套环以作为组织中的第三锚定套环来固定组织，所述锚定套环防止所述缝合线沿所述第一端部的部署方向运动。
在本发明的一些实施例中，提供一种自固位缝合线，其具有：用于穿透组织的第一端部；具有周边和横截面的细长缝合线主体，所述横截面具有横向长度；第一多个固位体，其位于所述细长主体的所述周边上并且取向至所述第一端部，所述第一多个固位体在缝合线沿所述第一端部的部署方向运动穿过组织期间朝缝合线主体屈曲，且抵抗缝合线在组织中沿与第一端部的部署方向基本上相反的方向运动；具有滑结的第二端部，所述滑结包括具有可变周长的套环，使得可通过滑动所述滑结来改变所述套环的周长，且所述第一端部可穿过所述套环以作为锚定件来固定组织，所述锚定件用于防止缝合线沿所述第一端部的部署方向运动。
在本发明的一些实施例中，提供一种自固位缝合线，其包括：用于穿透组织的第一端部；具有周边和横截面细长缝合线主体，所述横截面具有横向长度；第一多个固位体，其位于所述细长主体的所述周边上并且取向至所述第一端部，所述第一多个固位体在缝合线沿所述第一端部的部署方向运动穿过组织期间朝缝合线主体屈曲，且抵抗缝合线在组织中沿与第一端部的部署方向基本上相反的方向运动；以及具有滑结的第二端部，所述滑结包括具有可变周长的套环。滑动滑结导致所述套环的周长改变，且所述第一端部可穿过所述套环以固定组织，从而在组织中形成锚定套环，以用于防止缝合线沿第一端部的部署方向运动。
在本发明的一些实施例中，提供一种自固位缝合线，其包括：用于穿透组织的第一端部；具有周边和横截面的细长缝合线主体，所述横截面具有横向长度(tl)；第一多个固位体，其位于所述细长主体的所述周边上并且取向至所述第一端部，所述第一多个固位体在缝合线沿所述第一端部的部署方向运动穿过组织期间朝缝合线主体屈曲，且抵抗缝合线在组织中沿与第一端部的部署方向基本上相反的方向运动；以及具有可变周长的可变套环第二端部，其中所述可变套环包括固定套环，所述固定套环具有内部横向长度(TL)并滑动地接合所述细长主体，使得可通过滑动所述滑结来改变所述套环的周长。TL：tl的比率为大约1：1至大约10：1。第一端部可穿过所述可变套环以作为锚定件固定组织，所述锚定件用于防止缝合线沿第一端部的部署方向运动。
在本发明的自固位缝合线的任何实施例中，所述缝合线可还包括治疗剂。
本发明还提供通过此类改良的小直径自固定缝合线而启用的临床方法和手术。
在一个实施例中，提供一种缝合组织的方法，所述方法包括：(a)提供缝合线，所述缝合线附接至缝合针，所述缝合线的一部分形成具有可调式周长的套环；(b)将所述针穿过所述套环；以及(c)穿过患者的组织来部署所述针，并将所述组织与所述缝合线逼近。任选地，以下陈述中的一个或多个可进一步描述此实施例：所述套环包括缝合线和固定套环，所述固定套环具有开口，所述缝合线穿过所述开口从而形成具有可调式周长的套环；在所述组织已被完全逼近之后，所述固定套环以及通过所述固定套环形成的或附接至缝合线的任何装置均位于所述组织的表面上；在所述针穿过所述套环之前，将所述套环的周长调整至期望值；在所述针穿过所述套环之后，将所述套环的周长调整至期望值；将所述套环的周长调整至0.5英寸至3英寸范围内的期望值；将所述套环的周长减小至期望值；在将所述针穿过所述套环之前，使所述针分别在第一位置处穿入组织中并在第二位置处离开组织；所述缝合线包括组织固位体；所述缝合线包括缝合线中的切口，所述切口形成组织固位体，任选地，切口位于单个平面或两个平面内；缝合线中的切口提供倒钩，所述倒钩为组织固位体，且所述缝合线中存在多个切口；组织固位体存在于缝合线的形成具有可调式周长的套环的部分上；具有可调式周长的套环的一部分不存在组织固位体。
在另一个实施例中，提供一种将缝合线锚定在患者组织上的位置处的方法，所述方法包括：(a)为缝合线提供孔眼，所述缝合线在所述缝合线的部署端部处附接至缝合针；(b)在所述位置处将所述缝合针部署到组织中，并接着在出口点处从组织退出所述缝合针；(c)将所述针穿过包括缝合线的套环，所述套环具有可变周长；(d)通过拉动所述缝合线的所述部署端部来对所述缝合线施加张力；(e)从而在所述组织的顶部上提供锚定件，所述锚定件包括孔眼、所述套环和所述缝合线的一部分，所述锚定件抵抗所述缝合线沿所述缝合线的所述部署端部方向运动。
在以下的描述中说明了一个或多个实施例的详细内容。根据具体实施方式、附图、以及权利要求书，本发明的其他特征、目的、和优点将显而易见。
附图说明
本发明的特征、性质以及其各种优点在附图和以下本发明的具体实施方式中将是显而易见的。
图1A和1C是根据本发明实施例的自固位式可变套环缝合线的视图。
图1B是图1A所示缝合线沿图1A中的标为“1B”的线截取的剖视图。
图2是根据本发明另一实施例的自固位式可变套环缝合线的视图。
图3是根据本发明另一实施例的自固位式可变套环缝合线的视图，所述自固位式可变套环缝合线在其部署端部处具有针。
图4A和4B是根据本发明实施例的使用自固位式可变套环缝合线的方法。
图5A是根据本发明实施例的自固位缝合线的可变套环部分的视图，其示出固定套环的可视分界线。
图5B是根据本发明实施例的自固位缝合线的可变套环部分的视图，其示出实施例的表面结构。
图5C是根据本发明实施例的自固位缝合线的可变套环部分的视图，其示出该实施例的表面结构。
图5D是根据本发明实施例的自固位缝合线的可变套环部分的视图，其示出该实施例的表面结构。
图6A是根据本发明实施例的自固位缝合线的可变套环部分的视图，其示出该实施例的固定套环的可视分界线。
图6B是根据本发明又一实施例的自固位缝合线的可变套环部分的视图，其示出该实施例的抓紧接合元件。
图6C是根据本发明又一实施例的自固位缝合线的可变套环部分的视图，其示出该实施例的抓紧接合元件。
图7是根据本发明又一实施例的自固位缝合线的可变套环部分的视图，其示出该实施例的固定套环的构型。
图8是根据本发明又一实施例的自固位缝合线的可变套环部分的视图，其示出该实施例的固定套环的构型。
图9是根据本发明又一实施例的自固位缝合线的可变套环部分的视图，其示出该实施例的固定套环的构型。
具体实施方式
定义
可在本文中使用的某些术语的定义包括如下。
“配备的缝合线”是指在缝合线部署端部处具有缝合针的缝合线。
“编织缝合线”是指包括多丝缝合线的缝合线。这种缝合线中的丝线通常编织、拧绕、或针织在一起。
“降解性(也称为“生物降解性”或“生物吸收性”)缝合线”是指在引入到组织中之后被身体分解或吸收的缝合线。通常，降解过程至少部分地由生物体系介导或者在生物体系内进行。“降解”是指聚合物链裂解成低聚物或单体的断链过程。断链过程可通过多种机制来进行，所述机制包括(例如)通过化学反应(如，水解、氧化/还原、酶机制或这些机制的组合)或者通过热方法或光解方法。聚合物降解可(例如)利用凝胶渗透色谱法(GPC)来表征，所述凝胶渗透色谱法监测溶蚀和分解过程中的聚合物分子量变化。可降解缝合线材料可包括诸如聚乙醇酸之类的聚合物，乙交酯和丙交酯的共聚物，三亚甲基碳酸酯和乙交酯与二甘醇的共聚物(例如，Tyco Healthcare Group的MAXONTM)，由乙交酯、三亚甲基碳酸酯、和二氧环己酮构成的三元共聚物(例如，Tyco Healthcare Group的BIOSYNTM[乙交酯(60％)、三亚甲基碳酸酯(26％)、和二氧环己酮(14％)])，乙交酯、己内酯、三亚甲基碳酸酯和丙交酯的共聚物(例如，Tyco Healthcare Group的CAPROSYNTM)。这种缝合线可呈编织多丝形式或单丝形式。用于本发明中的聚合物可为直链聚合物、支链聚合物或多轴聚合物。用于缝合线中的多轴聚合物的实例在美国专利申请公开号20020161168、号20040024169和号20040116620中有所描述。由降解性缝合线材料制成的缝合线在该材料降解时会损耗拉伸强度。
医疗装置”或“植入物”是指为了恢复生理功能、减轻/缓解疾病相关症状、和/或修复/替换损坏的或病态的器官和组织的目的而放置在体内的任何物体。尽管通常由外源的生物相容性合成材料(例如，医用级不锈钢、钛和其他金属；诸如聚氨酯等聚合物、硅、PLA、PLGA和其他材料)构成，然而一些医疗装置和植入物也包括源自动物的材料(例如“异种移植物”，例如整个动物器官；动物组织，例如心脏瓣膜；天然存在的或化学改性的分子，例如胶原、透明质酸、蛋白、糖、以及其他分子)、源自人体供体的材料(如，异体移植物，例如整个器官；组织，例如骨移植物、皮肤移植物、和其他移植物)、或者源自患者自身的材料(如，“自体移植物”，例如隐静脉移植物、皮肤移植物、腱/韧带/肌肉植入物)。可结合本发明用于手术中的医疗装置包括但不限于整形外科植入物(人工关节、韧带、和腱；螺钉、螺丝板、和其他可植入的硬件)、牙植入物、血管内植入物(动脉和静脉血管搭桥移植物、血液渗析进入移植物；两者均为自体的和合成的)、皮肤移植物(自体的、合成的)、导管、引流管、植入式组织填充剂、泵、分流管、密封剂、外科网(如，疝修复网、组织支架)、瘘治疗物、脊柱植入物(如，人造椎间盘、脊柱融合装置等)。
“单丝缝合线”是指包括单丝缝合线的缝合线。
“针附接”是指将针附接至需要所述针以部署到组织中的缝合线并且可包括下述方法，例如卷曲、旋压、使用粘合剂等等。缝合线与针的附接点称为旋压点。
“针直径”是指缝合线部署针在该针的最宽点处的直径。尽管术语“直径”通常与圆形周边相关，但在本文中应当理解为指示与具有任何形状的周边相关的横截面尺寸。所述尺寸是形状周边上两点之间的最长尺寸，即周边上的彼此距离最远的两个点之间的距离。
“非降解性(也称为“非吸收性”)缝合线”是指包含下述材料的缝合线，所述材料为通过断链方法，例如化学反应方法(如，水解、氧化/还原、酶机制或这些机制的组合)或者通过热方法或光解方法不降解的材料。非降解性缝合线材料包括聚酰胺(也称为尼龙，例如尼龙6和尼龙6.6)、聚酯(例如聚对苯二甲酸乙二醇酯)、聚四氟乙烯(例如聚膨胀型四氟乙烯)、聚醚-酯(例如聚丁烯酯(对苯二甲酸丁二醇酯和聚四亚甲基醚二醇的嵌段共聚物))、聚氨酯、金属合金、金属(例如不锈钢丝)、聚丙烯、聚乙烯、丝绸、和棉花。由非可降解缝合线材料制成的缝合线特别适用于其中缝合线旨在永久性地保留或者旨在从身体物理性地移除的应用。
“固位体构型”是指组织固位体的构型并且可包括如下特征，例如尺寸、形状、表面特性等等。这些构型有时也称为“倒钩构型”。
“自固位缝合线”是指如下缝合线：其不需要在其至少一个端部上具有结或锚定件来保持其在外科手术期间所被部署于其中的位置。这些缝合线可为单丝缝合线或编织缝合线，且分两个阶段(即部署和固定)被定位在组织中，且包括至少一个组织固位体。
“自固位系统”是指自固位缝合线连同用于将缝合线部署到组织中的装置。这种部署装置包括但不限于用于穿透组织的缝合针和其他部署装置以及缝合线自身上的足够刚性和尖锐的端部。
“缝合线部署端部”是指待部署到组织中的缝合线的端部。诸如缝合针等部署装置可位于缝合线部署端部处，或者缝合线可形成为足够尖且刚性的结构以便靠其自身来穿透组织，此尖的且刚性的结构位于缝合线的缝合线部署端部处。
“缝合线直径”是指在横截面中观察时缝合线主体的直径。尽管术语“直径”通常与圆形周边相关，但在本文中应当理解为指示与具有任何形状的周边相关的横截面尺寸(或距离、或长度)。对于非圆形形状，直径是横截面周边上的任意两点之间的最长距离，也可被称为横截面距离。缝合线主体或线的横截面形状是沿缝合线在无倒钩的位置处观察所得，或者在所存在的倒钩被推靠到缝合线主体上使得其与缝合线主体的表面齐平的位置处观察所得。在一个实施例中，缝合线主体或线具有大致圆形的横截面形状。尽管缝合线主体可具有圆形或大致圆形的横截面形状，但所述横截面形状可为非圆形的，例如其可为多边形、例如三角形、四边形、五边形或六边形。缝合线主体的横截面可为椭圆形、椭圆体、长方形或半圆形外观。缝合线定径取决于直径。缝合线尺寸的美国药典(“USP”)标示为较大范围上的0至7和较小范围上的1-0到11-0；在较小范围上，-0之前的数值越大，则缝合线直径越小。在USP命名系统下，缝合线的实际直径将取决于缝合线材料，使得(以举例的方式)具有尺寸5-0并且由胶原构成的缝合线将具有0.15mm的直径，而具有相同USP尺寸标示但由合成吸收性材料或非吸收性材料制成的缝合线将各自具有0.1mm的直径。针对特定目的选择的缝合线尺寸取决于下述因素，例如待缝合组织的特性和美容问题的重要性；尽管较小的缝合线可更易于操纵穿过紧密外科部位并且与较小疤痕相关联，但由给定材料制备的缝合线的拉伸强度往往会随尺寸减小而降低。应当理解，本文所公开的缝合线和制备缝合线的方法适用于多种直径，包括但不限于7、6、5、4、3、2、1、0、1-0、2-0、3-0、4-0、5-0、6-0、7-0、8-0、9-0、10-0、和11-0。应当理解，本文所述的缝合线可采用多种缝合线长度。
“缝合针”是指用于将缝合线部署到组织中的针，所述针采用许多不同的形状、形式、和组成。存在两种主要类型的针：有创针和无创针。有创针具有孔隙或钻孔端部(即，针孔或针眼)，独立于缝合线来提供，并且进行现场接线。无创针为无针眼的并且在工厂处通过旋压附接至缝合线，由此将缝合线材料插入针钝端的孔隙内，随后使所述孔隙变形至最终形状以将缝合线和针保持在一起。由此，无创针在现场无需附加的时间来接线并且针附接位点处的缝合线端部小于针主体。在有创针中，线从在两侧上的针孔穿出，并且当缝合线穿过组织时，通常在一定程度上撕裂组织。大多数现代缝合线为旋压的无创针。无创针可永久性地旋压至缝合线或者可被设计为利用迅速直接的拉拽除去缝合线。这种“拽断点”通常用于间断式缝合线中，其中每个缝合线仅穿过一次并且随后进行打结。对于不间断的带倒钩的缝合线，这些无创针是理想的。可根据缝合针的尖端几何形状来对缝合针进行分类。例如，针可为(i)“锥形的”，由此针主体为圆形的并且平滑地渐缩至尖端；(ii)“切割的”，其中针的主体为三角形并且在内部具有锋利的刀刃；(iii)“反向切割的”，由此切割边缘位于外侧；(iv)“套管针点”或“渐缩切口”，由此针主体为圆形和锥形的，但端部位于小的三角切割点中；(v)“钝”点，用于缝合脆性组织；(vi)“侧面切割”或“刮刀点”，由此针在顶部和底部为平坦的且具有沿着前面到达一个侧面的切割边缘(这些通常用于眼外科)。缝合针也可具有若干形状，包括(i)直线形状、(ii)半弯曲或滑雪板形状、(iii)1/4圆形状、(iv)3/8圆形状、(v)1/2圆形状、(vi)5/8圆形状、和(v)复曲线形状。缝合针描述于美国专利号6,322,581和6,214,030(Mani，Inc.，Japan)；以及5,464,422(W.L.Gore，Newark，DE)；以及5,941,899；5,425,746；5,306,288和5,156,615(US Surgical Corp.，Norwalk，CT)；以及5,312,422(Linvatec Corp.，Largo，FL)；以及7,063,716(Tyco Healthcare，North Haven，CT)中。其他缝合针描述于例如美国专利号6,129,741；5,897,572；5,676,675；和5,693,072中。可利用多种针类型(包括但不限于弯曲的、直的、长的、短的、微小的等等)、针切割表面(包括但不限于切割的、锥形的等等)和针附接技术(包括但不限于钻孔端部、卷曲的等等)来部署本文所述的缝合线。此外，本文所述的缝合线自身可包括足够刚性和锐利的端部以便完全消除对部署针的需求。
“缝合线”是指缝合线的丝状主体组成，且对于需要针部署的缝合线而言不包括缝合针。缝合线可为单丝的(即由单条细丝形成)或多丝的(即由两条或更多条细丝的组合形成，例如以编穗形式排列的三条细丝)。术语“细丝”和“丝状的”以其普通意义使用，是指细长结构，因此在本文的许多情况下，缝合线也被称为细长主体或细长缝合线主体，这些术语是可互换的。细丝状缝合线的长度是其直径的许多倍，且在各种实施例中，缝合线的长度是缝合线直径的至少5倍、或至少10倍、或至少20倍、或至少30倍、或至少40倍、或至少50倍。实际上，缝合线的长度可甚至为缝合线直径的至少100倍。除为细丝状之外，缝合线是高度柔性的。换句话讲，当外科医生穿过患者的组织来移动缝合线时，缝合线将在任何方向上弯曲。缝合线可对其储存状况具有某种记忆，例如，如果缝合线以卷绕的圆形形式储存很长一段时间，则在从其存储容器中释放且被展开之后，缝合线可能趋于回到该种形式。然而，缝合线仍会沿其所附接的针穿过并围绕组织或伤口所产生的任何路径来跟随针行进。因此，缝合线可被描述为柔性的或柔韧的。换句话讲，缝合线的两个相邻线段可相对于彼此以基本上或非常接近0(此时两个线段向后折叠在彼此上)至180度(此时两个线段沿单条直线一前一后地跟随)的任何角度放置。缝合线具有长度，所述长度通常为至少5英寸、或至少10英寸、或至少15英寸、或至少20英寸。所述缝合线通常具有两个端部，其可被描述成部署端部和/或尾端。此这种情况下，缝合线的部署端部是首先进入组织的端部，其通常邻近针，而缝合线的尾端则为缝合线的非部署端部的端部。
“组织抬升手术”是指将组织从较低高度重新定位到较高高度(即，沿着与重力方向相反的方向移动组织)的外科手术。面部的保持韧带将面部软组织支承在正常的解剖位置。然而，随着年龄的增加，重力效应会向下拉动此组织和潜在的细丝，且脂肪会下行到表层和深层面部筋膜之间的平面上，从而使面部组织下垂。整容手术被设计为提升这些松垂组织，并且是称为组织抬升手术的医疗手术的较常见类型的一个实例。更一般地讲，组织抬升手术反转因下述效应引起的外观变化：随时间推移的重力效应以及导致组织松垂的其他时间效应，例如遗传效应。应该指出的是，组织也可在没有抬升的情况下进行重新定位；在一些手术中，将组织向外侧(远离正中线)、向内侧(朝向正中线)、或向下侧(较低的)进行重新定位以便恢复对称性(即，进行重新定位以使得身体的左侧和右侧“匹配”)。
“组织固位体”或简称“固位体”是指具有从缝合线主体突出的固位体主体以及适于穿透组织的固位体端部的缝合线元件；组织固位体的例子是倒钩。通过被基本取向至部署方向(即，当沿部署方向拉动时其平展放置，且当沿与部署方向相反的方向拉动时其打开或“展开”)，每一固位体均适于抵抗缝合线沿除临床医生将缝合线部署在组织中的方向之外的方向运动。在部署期间，当运动穿过组织时，随着每个固位体点的组织穿透端转离该部署方向，该组织固位体在此阶段期间不应当捕捉或抓住组织。一旦自固位缝合线已被部署，沿另一个方向(通常基本上与部署方向相反)施加的力就使得固位体从部署位置移位(即，基本上朝缝合线主体屈曲或沿缝合线主体倚靠)、迫促使固位体端部以捕获且穿透到周围组织中的方式从缝合线主体打开(或“展开”)，并且导致组织被捕获在固位体和缝合线主体之间，从而将自固位缝合线“锚定”或附连就位。
“单向缝合线”是指具有部署端部、尾端、以及取向至部署端部的固位体的缝合线。通过在尾端中打结或设置锚定元件，可利用尾端来防止缝合线沿部署方向运动离开组织，所述锚定元件保持在缝合线的部署端部最初插入组织中的点之外。(相比之下，双向缝合线在一端处具有沿一个方向取向的固位体并且在另一端处具有沿另一个方向取向的固位体。双向缝合线通常在缝合线的每个端部处均配备有针。双向缝合线可具有位于两个固位体取向之间的无固位体过渡区段。
“伤口闭合术”是指用于闭合伤口的外科手术。损伤，尤其是其中皮肤或者另一个外部或内部表面被切割、撕裂、刺穿、或者说是弄破的损伤，被称为伤口。当任何组织的完整性受损(如，皮肤断裂或烧伤、肌肉撕裂、或骨折)时通常会产生伤口。伤口可由以下各项引起：诸如中枪、跌倒或外科手术之类的动作；由传染病；或由潜在医学病症引起。外科伤口闭合术通过接合或紧密地拉近其中组织已撕裂、切割、或者说是分离的这些伤口的边缘而有利于生物学愈合情况。外科伤口闭合直接地附接或拉近组织层，这起到使桥接伤口的两个边缘之间的间隙所需的新组织形成的体积最小化的作用。闭合术可用于功能和美学目的。这些目的包括通过拉近皮下组织来消除死空间、通过细致的表皮对准来最小化疤痕形成、以及通过皮肤边缘的精确外翻来避免凹陷疤痕。
单向自固位缝合线
自固位缝合线(包括倒钩缝合线)不同于传统缝合线之处在于，自固位缝合线具有大量微小的组织固位体(诸如倒钩)以用于在部署后锚固至组织中并抵抗缝合线在与固位体所面对的方向相反的方向上的运动，从而无需本来所必需的在缝合线的部署端部周围打结动作就能在缝合线部署端部从组织离开的位点将相邻组织附连在一起(“无结”闭合)。由于无需打结，因此消除了相关联的并发症，包括但不限于(i)刺穿(在皮下闭合之后缝合线(通常为缝合线结)穿过皮肤的情况)，(ii)感染(细菌通常能够附接和生长在由结形成的空间中)，(iii)膨胀/成块(遗留在伤口中的大量缝合材料是构成结的部分)，(iv)滑移(结可滑动或解开)，以及(v)发炎(结充当在伤口中的大块“异物”)。通过在外科手术期间打结而在组织中形成的缝合线套环可导致局部缺血(其形成张力点，所述张力点可使组织血流受阻并限制血液流到该区域)并增大外科伤口裂开或破裂的风险。打结还为劳动密集型的并且可占用在闭合外科伤口中所花费的时间中的显著百分比。额外的手术操作时间不仅对患者有害(并发症发生率随麻醉下所花费的时间而增加)，而且还增加手术的整体成本(多种外科手术据估计每分钟手术时间花费$15至$30)。因此，无结缝合线不仅能够使患者体验改善的临床结果，而且能够节省与延伸手术和跟踪治疗相关联的时间和成本。
用于伤口闭合的自固位缝合线系统还导致较好的伤口边缘拉近、沿伤口的长度均匀地分布张力(减少可断裂或导致局部缺血的张力区域)、减小保留在伤口中的缝合线材料的团块(通过消除在手术期间打结)以及减少泌液(缝合线材料(通常为结)挤出穿过皮肤表面)。相对于使用普通缝合线或缝钉而实现的伤口闭合而言，这些特征中的全部据认为会减少结疤、改善美容效果、以及增加伤口强度。
自固位缝合线还适于各种专门的适应症；例如，其适用于组织抬升手术，其中组织从其先前位置运动并被重新定位到新的解剖位置中(此通常在其中将“下垂”组织抬升并固定到更“年轻”的位置；或者其中将“位置不当”的组织移回至其恰当解剖学位置的整容手术中执行)。此种手术包括面部拉皮手术、前额拉皮手术、乳房提升手术、臀部提升手术等等。
单向自固位缝合线及其使用以在上述各种专利公开中有所描述。尽管邻近单向自固位缝合线部署端部的缝合线区段设置有用于防止缝合线沿与部署方向相反的方向滑动的组织固位体，然而尾端可设置有防止沿部署方向滑动的锚定件(且以便避免需要在外科手术期间在单向缝合线的尾端中打结的不期望的潜在效应)。具有锚定件(包括具有套环元件的锚定件)的各种单向缝合线已在例如美国专利申请公开号20050267531、20040060410、20080255611和20100063540中有所描述。
本发明的实施例能够解决现有的具有套环锚定件的单向自固位缝合线中所常见的若干问题。例如，具有固定套环锚定件的单向缝合线(诸如在上述公开中的某些公开中所述的单向缝合线)具有若干缺点，第一个缺点是，固定套环的尺寸通常应相当小(即，不比临床医生希望用固定套环制成的第一针脚的尺寸大很多)，这需要临床医生耗费一些精力来找到套环(因此会花费一些宝贵的手术时间)并将缝合线的部署端部穿过所述套环。因为本发明的缝合线包括可变套环锚定件，所以为临床医生呈现大的套环，使得其能够轻易地将缝合线的部署端部穿过该套环；这尤其在腹腔镜式手术中具有有益效果。接着，当穿过组织拉动此种缝合线时，如果在缝合线主体已被拉过组织且被拉紧之后所得的第一针脚大于固定套环的最长内部尺寸，则套环的基部(即，套环接合缝合线主体处)可被拉到组织中，从而导致潜在的问题(诸如上述结合打结所述的问题)。另一方面，如果在缝合线主体已被拉过组织且被拉紧之后所得的第一针脚小于固定套环的最长内部尺寸，则过量的套环材料会保留在组织部位处，此为逻辑上不期望的病症，也可使外科器械在手术期间被捕获在多余的材料上。在本发明的情形中，可变套环锚定件的可调整性质允许临床医生避免这些困难。
此外，存在与固定套环锚定件相关联的套环整体性的物理问题。例如，可通过本发明的可变套环缝合线来避免固定套环附接的问题。其中固定套环缝合线的套环被焊接或以其他方式附接至缝合线主体，以作为在其基部处接合到缝合线的单独结构或者作为缝合线的返回到组织上并附接至组织以形成套环部分的端部，套环的基部(其接合缝合线主体处)是附接区域，也是缝合线被拉到组织中的部位。因此，其受到组织拖拽并可能在附接区域处断裂或剥离。尽管此可通过增大附接区域的长度和/或提供锥形物或斜面来解决，然而可通过本发明的缝合线来完全避免，这是因为可变套环的孔眼将坐在所逼近的组织的表面上，无需穿过组织中，且不会受到组织拖拽。此外，对于本发明的缝合线而言，在张紧组织时的主要负荷由与孔眼相对的可变套环承受。结果，孔眼在座置第一针脚时不保持主要张力，且焊接长度可缩短，从而降低对伤口愈合的局部生物材料效应(炎症和/或感染的危险)。
本发明的单向自固位缝合线在一个端部处设置有可变长度套环，且在另一端部处设置有部署端部。通过以下方式来实现伤口闭合：在包括欲被逼近的组织的伤口的一个端部处开始，将部署端部穿过组织的两个边缘，穿过组织拉动缝合线的包含针的端部，直到套环区段靠近组织的第一边缘，并将具有针的端部返回穿过装置的可变套环部分。拉动张力，直至套环座置在组织上并实现期望的保持。现在，部署端部以临床医生所决定的图案重复地穿过组织，以最佳地有利于伤口闭合，所述伤口闭合开始时，刚刚座置的端部沿着朝向欲被逼近的组织的另一终点的一个方向运动。类似于与双向构型一起使用的手术，可利用“J形针脚”来完成手术过程并移除针。
现在参见图1A、1B和1C，其中示出了在细长主体102上具有部署端部101的缝合线100，缝合线100作为另外一种选择在本文中可被称为缝合线，其主体(或线)具有横截面长度(横截面上的最长横向尺寸)。图1B中示出了此横截面长度，其中图1B是图1A的缝合线沿图1A中的标为“1B”的线截取的剖视图，其中此横截面长度由图1b中的“tl”表示，且图1B还显示缝合线主体102的横截面以及均被标识为104的三个固位体，所述三个固位体以不同的暗色显示，以说明其并非与位于位置1B处的观看者距离相同的距离。应当理解，缝合线的横截面形状并非仅限于圆形，而是也可为非圆形的(诸如椭圆形、三角形、正方形、其他多边形等)。
继续参见图1A至1C，主体102具有朝部署端部101取向的多个固位体104以及孔眼112，缝合线主体通过孔眼112穿过从而形成可变套环108。所述孔眼实质上是固定套环，但是其在组织中位于其中部署有缝合线的组织的外部。可变套环作为锚固结构的一部分而存在，此能确保施加在锚定件上的所有力不会单独地施加在固定套环上。这是有利的，因为力因此而分布在更宽广的结构上，且固定套环(孔眼)或其部分(例如本文在下文中所述的附接区域)不会被拉到组织中。一种有益效果是，可更容易地找到锚定件并接着将其从缝合线切除，从而允许在视为愈合过程不再需要缝合线的存在之后更容易地移除缝合线。在不存在可变套环时，锚定件将仅由孔眼构成或由孔眼结合穿过孔眼但不形成可变套环的缝合线的一部分而构成。观察仅由固定套环形成的锚定件或、由固定套环结合穿过固定套环但不形成可变套环的缝合线形成的锚定件，使其将组织夹在锚固点处并可导致不期望的副作用(例如组织坏死)。由固定套环(孔眼)和可变套环以及细长主体(缝合线)的一部分形成的锚定件能够夹持更少的组织，从而使导致不期望组织坏死的几率更低。
如图1C所示，部署端部101可穿过可变套环108。随着部署端部101继续穿过可变套环108而被拉动，且张力从部署端部101的方向被施加到缝合线102，缝合线102的越来越多的部分通过可变套环而被拉动或穿线。在实际操作中，部署端部101在穿过可变套环108之前会穿过患者的组织，因此随着缝合线102穿过可变套环108，孔眼112将朝患者组织的表面被拉动，且最终将被施加在部署端部101上的张力或力牢固地保持在组织上。随着继续拉动或施加力或张力，可变套环的周长将趋于减小，直至临床医生确定可变套环具有期望的周长的时刻，此时临床医生将停止拉动部署端部，从而形成锚定件。随后，临床医生将重新用现在被锚固的缝合线来缝合患者的组织。
如图1A和1C所示，缝合线主体的沿其设置有多个固位体的区域可大于缝合线主体的用于形成孔眼的区域。此外，孔眼无需包含任何固位体，然而可存在一种固位体以便有助于将缝合线主体夹持在孔眼中。缝合线的可变套环部分可不包括固位体，如图1A和1C所示，或者缝合线的此部分中可存在固位体，如本文所提供的后面的图所示。
在图2中可见，缝合线200可在缝合线主体202上具有固位体204，所述固位体沿缝合线主体202的长度的大部分(包括由缝合线主体202形成的可变套环208)以接近孔眼212。由于固位体204朝向缝合线200的部署端部201取向，因此当沿部署方向穿过孔眼212来拉动缝合线(或者在缝合线主体202上拉动孔眼212)以减小可变套环208的周长时，孔眼212容易地经过缝合线202和位于缝合线上的固位体204。
如通过比较图2和图3所示，缝合线200和300的部署端部可分别为尖的。如图2所示，通过将缝合线主体202的端部转换成尖锐的及刚性的结构，部署端部201可为尖的。或者，如图3所示，部署端部301可由于针303附接至缝合线302的终点而变成尖的。图3显示可变套环缝合线300的部署端部301处的针303。
在一个实施例中，本发明提供包括本文所述自固位缝合线的自固位系统，所述自固位系统包括部署装置。自固位缝合线包括缝合线，所述缝合线具有多个组织固位体和一个或多个(通常仅需一个)孔眼。所述孔眼可形成为圆形或大致圆形的形状，且在此种形状中，孔眼的直径可以通常的方式测量为孔眼内侧上的任何两个相对点(位于圆的相对侧上的两个点)之间的距离。针直径可根据孔眼直径来选择。例如，针直径可大于孔眼直径，例如，针直径可比孔眼直径至少大5％、至少大10％，或者至少大15％或至少大20％。在此例子中，当缝合线主体的部署端部穿过孔眼且然后缝合线的部署端部附接至缝合针时会形成固定套环。由于缝合针具有大于孔眼直径的直径，因此无法在不使孔眼和/或针断裂的情况下将缝合线的部署端部回穿过孔眼，除非孔眼是由能够拉伸的柔性材料制成。本发明的缝合线主体通常无需拉伸到任何可感知的量值。因此，所述套环可视为固定套环。又如，针直径大约与孔眼直径相同，换句话讲，针直径是孔眼直径的加/减5％，或者在另一个实施例中为孔眼直径的加/减10％。在这种情况下，针直径和孔眼直径近似相同，且在部署端部已附接至针之后，难以或无法将缝合线的部署端部回拉过孔眼。又如，针直径被选择成小于孔眼直径，例如其中针直径比孔眼直径小90％，或者比孔眼直径小80％、或小70％或小60％或小50％。在这种情况下，部署端部可附接至针，且随后针可穿过孔眼。此种选项在形成具有可变套环缝合线上具有更大的灵活性。
针直径通常被选择成至少与缝合线直径相同，且在各种实施例中，针直径是缝合线直径的至少110％、或至少120％、或至少130％、或至少140％、或至少150％。
图4A和图4B中示出了本发明的自固位式可变套环缝合线的使用。在这些图中，缝合线400被描绘成以第一针脚穿过组织(标为阴影区域“T”)，且细长主体402被描绘成穿过可变套环408。当缝合线400随后沿部署端部401的方向(以箭头表示)被拉动时，缝合线主体402继续穿过套环408，在穿过孔眼412时张紧可变套环并减小其尺寸。因此，缝合线被锚固且准备继续穿过组织进行部署。
在一个实施例中，本发明提供一种缝合方法，其中此种方法包括：(a)提供自固位系统，所述自固位系统包括附接在自固位缝合线的端部处的缝合针，所述自固位缝合线包括具有线直径的缝合线、多个组织固位体和孔眼，其中所述缝合线穿过孔眼以形成具有原始直径的可变套环；(b)将所述针在第一组织位置处插入患者的组织中；(c)在第二组织位置处从所述患者的所述组织退出所述针；(d)将所述针和所述缝合线的至少一些部分穿过所述可变套环；以及(e)将所述针在第三组织位置处插入所述患者的所述组织中。任选地，如本文所提供，以下陈述中的一个或多个可结合提供缝合方法的陈述来使用：所述缝合线穿过可变套环，而同时使可变套环的直径减小，其中任选地所述减小大于原始可变套环直径的50％；可变套环的直径减小，以提供为线直径的小于10倍的可变套环直径；可变套环的直径减小，直至可变套环围绕缝合线紧密贴合；缝合线穿过可变套环，直至孔眼、可变套环和缝合线主体一起在组织上形成锚定件，且其中锚定件抵抗缝合线沿缝合针的方向进一步运动。
在另一个实施例中，本发明提供缝合组织的方法，所述方法包括：(a)提供缝合线，所述缝合线附接至缝合针，所述缝合线的一部分形成具有可调式周长的套环；(b)将所述针穿过所述套环；以及(c)穿过患者的组织来部署所述针，并将所述组织与所述缝合线逼近。任选地，如本文所提供，以下陈述中的一个或多个可结合提供缝合方法的陈述来使用：所述套环包括缝合线和固定套环(也被称为孔眼)，所述固定套环具有开口，所述缝合线穿过所述开口从而形成具有可调式周长的套环；在组织完全逼近之后，固定套环(在本文中也称为孔眼)和固定套环形成或附接至缝合线所用的任何装置均位于组织的表面上；在将部署端部或针穿过可变套环之前，将可变套环的周长调整到期望值；在将部署端部或针穿过可变套环之后，将可变套环的周长调整到期望值；根据临床医生的习惯和被缝合伤口的性质，将套环的周长调整到范围内的期望值，该期望范围可为0.5英寸至3英寸或0.5英寸至2英寸，或0.5英寸至1英寸；针对临床医生的舒适度和被缝合的伤口，视情况将套环的周长减小到期望值(即临床医生所期望的值)；在将所述针穿过可变套环之前，使所述针分别在第一位置处穿入组织中并在第二位置处离开组织；所述缝合线包括组织固位体；缝合线包括缝合线中的切口，所述切口形成组织固位体，换句话讲，所述切口在切口任一侧上的缝合线材料之间提供分离，其中缝合线材料的更靠近缝合线周边的部分被向上拉动并远离切口另一侧上的缝合线，从而形成作为组织固位体的结构；在缝合线中所制作的切口位于单个平面内或两个平面内，诸如在缝合线中形成切口的过程中切口角度改变处，例如，缝合线中的第一切口相对陡峭，而第一切口之后的切口不(或不是非常)陡峭；在缝合线中制作切口以提供倒钩；组织固位体存在于缝合线的形成具有可调式周长的套环的部分上；具有可调式周长的套环的一部分不存在组织固位体。
在另一个实施例中，本发明提供一种缝合方法，其包括在患者组织上的位置处形成锚定件，所述方法包括：(a)为缝合线提供孔眼，所述缝合线在所述缝合线的部署端部处附接至缝合针；(b)在所述位置处将所述缝合针部署到组织中，并接着在出口点处从组织退出所述缝合针；(c)将所述针穿过包括缝合线的套环，所述套环具有可变周长；(d)通过拉动所述缝合线的所述部署端部来对所述缝合线施加张力；(e)从而在所述组织的顶部上提供锚定件，所述锚定件包括孔眼、所述套环和所述缝合线的一部分，所述锚定件抵抗所述缝合线沿所述缝合线的所述部署端部方向运动。任选地，如本文所提供，以下陈述中的一个或多个可结合提供缝合方法的陈述来使用：所述套环包括缝合线和固定套环(也被称为孔眼)，所述固定套环具有开口，所述缝合线穿过所述开口从而形成具有可调式周长的套环；在组织完全逼近之后，固定套环(在本文中也称为孔眼)和固定套环形成或附接至缝合线所用的任何装置均位于组织的表面上；在将部署端部或针穿过可变套环之前，将可变套环的周长调整到期望值；在将部署端部或针穿过可变套环之后，将可变套环的周长调整到期望值；根据临床医生的习惯和被缝合伤口的性质，将套环的周长调整到范围内的期望值，该期望范围可为0.5英寸至3英寸或0.5英寸至2英寸，或0.5英寸至1英寸、或至少0.5英寸、或至少1英寸、或至少1.5英寸；针对临床医生的舒适度和被缝合的伤口，视情况将套环的周长减小到期望值(即临床医生所期望的值)；在将所述针穿过可变套环之前，使所述针分别在第一位置处穿入组织中并在第二位置处离开组织；所述缝合线包括组织固位体；缝合线包括缝合线中的切口，所述切口形成组织固位体，换句话讲，所述切口在切口任一侧上的缝合线材料之间提供分离，其中缝合线材料的更靠近缝合线周边的部分被向上拉动并远离切口另一侧上的缝合线，从而形成作为组织固位体的结构；在缝合线中所制作的切口位于单个平面内或两个平面内，诸如在缝合线中形成切口的过程中切口角度改变处，例如，缝合线中的第一切口相对陡峭，而第一切口之后的切口不(或不是非常)陡峭；在缝合线中制作切口以提供倒钩；组织固位体存在于缝合线的形成具有可调式周长的套环的部分上；具有可调式周长的套环的一部分不存在组织固位体。
为实现允许临床医生识别和区分孔眼的目的，在孔眼附近放置标记物。所述标记物应在使用缝合线的条件下由医师轻易地识别和区分。例如，在显微外科应用中，可使用在显微镜下可见、但未必对肉眼可见的标记。同样，在内窥镜式应用中，应使用透过内窥镜和相关联的显示系统可见的标记。如果缝合线与荧光镜可视化一起使用，则标记物可包括不透射线的标记物。如果缝合线与超声可视化一起使用，则标记物可包括反射波的标记物。因此，根据手术环境和手术中所用的扫描/成像/可视化技术，在不同的环境下可适用不同的标记物和不同类型的标记物。
标记物可包括不同颜色(诸如红色、绿色、橘色、黄色、绿色、蓝色等)。在一些情况下可能期望使用在手术环境中不常见的标记物颜色。例如，可能期望的是使用绿色标记，原因是绿色在人体中不常见。在内窥镜式应用中使用绿色是有利的，这是因为可将视频系统程序化为强调绿色，并在不干扰图像其余部分的情况下增强标记物可视化。
标记可通过多种常规方法形成。例如，标记可以涂覆、喷涂、粘合、染色、着色或以其它方式附连到自固位缝合线系统或其各组件。传统的染色剂涂覆处理包括但不限于在关注的缝合线区段上浸渍、喷涂(通过例如喷墨)、喷绘、印刷、施加和/或涂覆染色剂。临界流体提取剂(例如碳氧化物)也可用于将染色剂局部添加到期望被标记的所有或部分区段。或者，用于关注的缝合线区段的一种或多种染色剂可包括在缝合线材料的用来形成缝合线主体的部分中，其中该部分处于制造的缝合线的关注区段中。
另外，所关注的缝合线区段可使用能量激活的染色剂来区别。例如，当使用激光激活的染色剂(即，在暴露到激光能量之后永久变色的颜料或燃料)来对缝合线进行着色时，可通过使用激光能量永久改变所关注缝合线区段中的缝合线涂层来区别孔眼或所关注的其他缝合线区段。此也适用于使用由其他能源(诸如但不限于热、化学品、微波、紫外光或x射线)激活的其他能量激活染色剂。例如，漂白化学品(诸如次氯酸钠或过氧化氢)将永久地改变染色剂的颜色，此使得能够对缝合线的孔眼或其他区域进行划分。
另外，用于区别关注的缝合线区段的一种或多种染色剂可包含在塑料生物相容性材料上，该塑料生物相容性材料在关注区段处施加在缝合线上。这样的层可为可吸收的，例如聚乙交酯涂层，其具有染色剂以标记关注的缝合线区段，或者其可为非吸收性材料，例如硅树脂。彩色材料可为合成的，或者可源自自然源(无论该材料被改良还是未被改良)，例如胶原。可在于缝合线主体上形成固位体之前或之后将塑料的生物相容性材料涂覆到缝合线。
或者，孔眼或其他缝合线区域可为反向标记的，使得在缝合线本体总是能够看到颜色的情况下，在全部或部分的关注缝合线区段上可不具有染色剂，使得外科医生能够在视觉上将关注区段的至少一部分与缝合线的其余部分区分开。通过在缝合线主体制造(例如通过挤出)期间使缝合线材料在关注的缝合线区段区域中包括无染色剂部分，或者无论在缝合线主体上形成固位体之前或之后，通过在已经制造缝合线主体之后从关注的缝合线区段移除染色剂，可制造这样的缝合线。例如，可通过临界流体提取剂例如(例如碳氧化物)局部移除染色剂。不需要从缝合线的关注区段移除全部染色剂，只要在关注区段与缝合线其余部分之间存在能够由外科医生检测到的差异即可。
反向标记缝合线的另一个例子是缺少存在于缝合线主体其余部分上的彩色层。支撑染色剂的塑料生物相容性材料可施加在缝合线的其它区段上，并且至少施加在比关注区段宽的其它区段处。这种材料的例子如上所述。如前述例子中所示，在形成固位体之前或之后，可在缝合线制造过程中实现关注的缝合线区段的区分。
反向标记缝合线的另一个例子是具有同轴结构的一个，其中每个同轴层具有不同的颜色，并且一个或多个最外层的一部分被移除，以在视觉上暴露下面的层。例如，多层单丝聚丙烯缝合线可形成有白色内芯(内部同轴层)，该白色内芯具有蓝色外部同轴层，并且外层的各部分可被移除，以在视觉上暴露白色内部单丝，从而标记关注的缝合线区段。
反向标记缝合线的另一个例子是，在关注的缝合线区段中从缝合线移除(或部分地移除)外部涂层，并且涂层或基部缝合线具有对比色差。在关注的缝合线区段中移除(或部分地移除)材料的这种技术还可形成关注的缝合线区段的触觉分界线。
所述标记可包括可由无线电探测的化合物或磁共振成像可探测的化合物。例如，可通过电磁能量来探测诸如通过用硫酸钡浸渍缝合线或添加包含硫酸钡的涂层而设置有硫酸钡(BaSO4)的所关注的缝合线区段。在x射线探测的情况下，用硫酸钡标记的所关注区段将为不透射线的。同样，可利用计算机断层照相术(CT)扫描或计算机轴向x线断层照相术(CAT)扫描来探测所关注的无线电可探测区段。对过渡区段进行无线电探测时对电磁能量的使用并非仅限于使用x射线波长，这是因为可使用其他射频。同样，可使用钆(Gd)或钆化合物来对所关注的缝合线区段进行标记，尤其是使用磁共振成像(MRI)来完成探测时。在腹腔镜式外科手术期间，使用无线电可探测或磁共振成像可探测的标记对于外科医生来说可为有用的。
可对可变套环的位于孔眼基部处的区域进行标记，以增大其对于外科医生的可视性，以实现在缝合线部署期间指明其位置的目的，或允许临床医生识别锚定件在何处以便将其切断，从而实现从组织移除所部署缝合线的目的。图5A、5B、5C和5D示出了具有此种标记的可变套环缝合线的尾端。在图5A中，缝合线500的可变套环508包括孔眼512，孔眼512在其基部514处被标记。图5B的缝合线520除包括邻近孔眼基部534的表面结构536之外还包括具有靠近孔眼532的分界线534的可变套环528，与缝合线上的其他位置相比，结构536在孔眼基部处提供对缝合线520的不同触觉，而图5C的缝合线540具有可变套环548，该可变套环具有靠近孔眼552的分界线554，且图5D的缝合线560显示可变套环568，该可变套环具有靠近孔眼572的两条分界线534和位于可变套环568其他位置的分界线576。
在一些实施例中，对于缝合线主体的邻近固定套环的一些部分而言，缝合线可另外设置有表面结构，以便提供一些抵抗性，使得临床医生可感知被一直拉到固定套环的可变套环。尽管在这些实施例中的一些中，表面结构不必防止可变套环被一直拉紧到固定套环，然而在另一些实施例中，表面结构可用于实现此功能。适宜表面结构的一些例子为凹窝、涟漪、褶皱、粗糙化、锯齿、脊、细丝等等，但并非仅限于此。就这一点而言，图5B包括靠近孔眼532的表面结构536。当然，这些表面结构也可采用远离缝合线部署端部而取向的短区段固位体的形式，此将抵抗缝合线主体穿过孔眼的运动。后者可因缝合线的平衡而具有相同的图案，或者可不同，即可为与取向至部署端部的多个倒钩具有相同或不同构型的短区段的固位体。
在图5C中，朝缝合线的部署端部取向的固位体544容易地穿过孔眼552，而固位体558沿相反方向取向并因此在某种程度上抵抗孔眼被拉过所述固位体。相似地，图5D的缝合线560设置有朝部署取向的固位体564以及相对取向的固位体578。缝合线560还在两组固位体之间设置有另外的标记576，以便允许临床医生识别所述两组固位体之间的区域。
现在参见图6A，其提供了根据本发明实施例的自固位缝合线600的可变套环部分608的视图，示出了该实施例的固定套环的可视分界线614。换句话讲，固定套环(或者称为孔眼)具有与接合缝合线相比不同的表面外观或不同的表面触觉。在图6A中，孔眼612由与形成接合缝合线602的材料相比颜色更深的材料构成。作为另外一种选择，孔眼可由比接合缝合线颜色更浅的材料或与其完全不同颜色的材料形成。所述孔眼可由具有粗面的材料形成，而接合缝合线具有自然或磨光的外观。孔眼也可或者作为另外一种选择由包含接合缝合线上不存在的沟槽或其他压痕或脊的材料形成，从而在孔眼区域和接合缝合线之间提供触觉区分。在孔眼和接合缝合线的此种可视分界线下，使用缝合线的临床医生或者可能操作缝合线的机器人可更容易地看见孔眼并将孔眼与接合缝合线区分开。
现在参见图6B和图6C，孔眼可设置有抓紧接合元件或与其相结合，以在决定从组织移除缝合线时有利于从缝合线移除锚定件。如图6B所示，缝合线620包括具有孔眼632的可变套环628以及具有突出部636作为抓紧接合元件的附接区域634，而图6C的缝合线640包括一定长度的无倒钩缝合线材料656，以作为位于可变套环648的整体形成的孔眼652上或作为其一部分的抓紧接合元件。抓紧接合元件636和656示出了作为孔眼的一部分或者附接至孔眼的结构的两个选项，且其尺寸和取向可使保健专业人员容易地抓紧或捕获或夹持或握持，以作为提升孔眼和相关锚定件远离组织的装置。抓紧接合元件是本文所述可变套环缝合线中的每一个的任选结构。
抓紧接合元件可由可吸收材料或不可吸收的材料制成。例如，可使用由聚酯毡或聚四氟乙烯毡制成的不可吸收的抓紧接合元件来使外科医生找到并轻轻地拉动孔眼，使得如果或当期望从组织移除缝合线(通过脱离锚定件并接着将缝合线从其部署端部拉出)时有利于从缝合线主体移除锚定件。可吸收材料的例子包括乙交酯和乙交酯-丙交酯聚合物。可吸收抓紧接合元件的使用可尤其适用于陡峭腔体组织闭合，其中，外科医生可能希望具有是否将抓紧接合元件留在主体内的选择。另外，抓紧夹持元件可被染色(如图6B的突出部636的阴影所示)来提高元件的可视性。此包括但不限于使用荧光染色剂、无线电可探测的化合物、或磁共振成像可探测的化合物。
制造和材料
可通过任何合适的方法来产生本文所述的缝合线，所述方法包括但不限于注模、冲压、切割、激光、挤出等等。就切割而言，可制造或购买聚合物型丝线以用于缝合线本体，并且随后可在缝合线主体上或缝合线主体中切割固位体；固位体可为利用刀片、切轮、砂轮等等进行手动切割的、激光切割的、或机械切割的。缝合线可由任何合适的生物相容性材料制成，并且可利用任何合适的生物相容性材料进行进一步的处理，以增强缝合线的强度、弹性、寿命或其它特性，或者用于配置缝合线，以便除了将组织接合在一起、重新设置组织或将外来元件附接至组织之外，还实现附加功能。适于所考虑缝合线的指示和使用，缝合线可设置有各种构型、排列、密度等的固位体，例如本文所参考的公开中所教示的那些固位体。
本发明的用于缝合线的可变套环可以若干种方式形成。参见图7所示的缝合线700，可变套环708包括孔眼712，缝合线主体702穿过孔眼712。通过以下形成孔眼712：将原本为缝合线主体702的非部署终点791的部分在其自身上来回经过，并将其在附接区域714处附接至缝合线主体702的外部。在这种情况下，附接区域714邻近孔眼712。相比之下，参见图8所示的缝合线800，其示出了在内部附接上由缝合线主体802的尾端(或称为非部署端部)891形成的可变套环808的孔眼812，即，附接区域814位于形成孔眼的结构的内侧且为该结构的一部分。参考这些附图所述的附接可通过焊接、胶合等而被制成具有永久性质。
值得注意的是，缝合线的非部署端部在位于附接区域中时无需具有任何特定的形状或外观或功能。由于本发明的可变套环缝合线的孔眼和相邻的附接区域均不旨在进入组织，因此无需通过提供任何利于此种进入的特定形状来利于例如附接区域的进入。例如，本发明的缝合线的非部署端部的端部或末端与相邻的缝合线的边相比可被做成方形的，而非具有将有利于进入组织的角度或斜度。事实上，部署端部可被设计成或适于阻碍附接区域进入组织。当通过使附接区域邻近孔眼定位而形成孔眼时，这是尤其重要的。如果附接区域是形成孔眼的材料的一部分，则此相同的问题不重要。
作为另外一种选择，孔眼912可与缝合线主体902为一体的，如图9所示的缝合线900所示，其中可变套环908的孔眼912与缝合线主体902是连续的。因此，在此实施例中不存在附接区域。
作为另一替代实施例，孔眼可与缝合线分开形成，随后将孔眼在适当位置处接合到缝合线。例如，可以与绳子的端部能够系到环上的相同方式将缝合线的非部署端部系到孔眼上。在此替代实施例中，期望以牢固的方式将缝合线和孔眼接合在一起，使得孔眼不会在不适宜的时刻与缝合线分离。例如，可通过焊接用于将孔眼系到缝合线的结来实现将孔眼和缝合线牢固地接合。又如，孔眼可采用环(或者多边形、或用于界定缝合线可经过或穿过的孔的其他适宜形状)的形式，其中所述环具有孔，使得缝合线可经过，以将环固定到缝合线。例如，在穿过此孔之后，缝合线的非部署端部可形成为结，该结的尺寸使其无法容易地穿过孔。如此一来，缝合线被固定到孔眼。再如，可将孔眼牢固地接合到结构，其中所述结构被容易地固定到缝合线。例如，以图8所示的形状接合的两个环(所述两个环不必具有相同的直径)提供一种结构，其中缝合线可系到一个环上，而接合环可用作孔眼。不使孔眼接合到环，而是可将孔眼接合到能够围绕缝合线折叠和卷曲的突出部。作为一种选择，孔眼可接合到中空的圆筒，其中可将缝合线的非部署端部插入圆筒中，随后卷曲圆筒以将缝合线固定在圆筒中(以与将缝合线的部署端部型锻到针的熟知方式相似的方式，但在这种情况下，缝合线的非部署端部将被型锻到孔眼)。使孔眼与缝合线分开形成能够在选择缝合线和孔眼的形成材料上提供更大的灵活性(即，非依赖性)。
孔眼的尺寸可改变；例如，孔眼的内部横向长度(即，贯穿孔眼的最长内部尺寸)可与缝合线主体横截面的横向长度(即，贯穿缝合线主体横截面的最长尺寸，与横截面的形状无关)大约一样小，且与缝合线主体横截面的横向长度的大约四倍或甚至十倍一样大。内部横向长度的其他可能适宜的长度范围是缝合线横截面的横向长度的1.5倍至缝合线横截面的横向长度的大约十倍、缝合线横截面的横向长度的1.5倍至缝合线横截面的横向长度的大约四倍、或者缝合线横截面的横向长度的两倍至缝合线横截面的横向长度的大约三倍。
在制备之后，可将自固位缝合线系统进行包装以便于储存、处理和使用。适宜的封装系统在本领域中是已知的，其中示例性缝合线包装件在美国专利公布号20110056859和20100230300中有所描述。在包装过程之前，但优选地在包装过程之后，例如通过辐射来对缝合线进行消毒。
在一个实施例中，提供一种制造自固位缝合系统的方法，所述方法包括：(a)提供缝合线，所述缝合线包括部署端部，且包括或附接至孔眼；(b)在所述缝合线中形成多个切口，以提供多个组织固位体；(c)将缝合线的部署端部穿过孔眼，从而形成具有可变周长的套环；(d)将缝合线的部署端部穿过具有可变周长的所述套环，以提供准备用于包装的缝合线；(e)将所述准备用于包装的缝合线放置到包装件中，所述包装件适于储存缝合线，并且适于使保健工作者容易地找到准备用于包装的缝合线。以下陈述中的一个或多个可与一种制造自固位缝合线系统的方法的说明结合使用，以进一步描述并说明本发明：所述方法还包括：将缝合针附接至缝合线的端部，其中任选地，针在缝合线的端部已穿过孔眼之后附接至缝合线，或者针在缝合线的端部已穿过具有可变周长的套环之后附接至缝合线；对所述缝合线进行消毒；所述孔眼与所述缝合线形成为一体；所述孔眼附接至所述缝合线；所述孔眼通过以下形成：(a)将所述缝合线的非部署端部(也称为缝合线的尾端)折回在缝合线的一部分上，以提供附接区域，其中缝合线的非部署端部在所述附接区域中接触所述缝合线的所述部分；以及(b)在所述附接区域中将缝合线的非部署端部和所述部分相互粘合，其中在这种情况下，所述粘合可通过在附接区域中将缝合线的非部署端部和所述部分焊接到一起而实现，或者可通过在附接区域中将缝合线的非部署端部和所述部分胶合在一起而实现；所述孔眼包括附接区域，这在其中部署端部被折回到缝合线的形成部分孔眼的部分上时会发生；所述孔眼邻近附接区域，这在以下情况中会发生：其中部署端部被折回到缝合线的一部分上，该部分不形成孔眼的一部分，但在孔眼的基部处邻近孔眼。
本文所述的自固位缝合线还可掺入进一步促进组织接合的材料。除能够增强固位体处的组织接合之外，在缝合线主体的至少部分中使用组织接合促进材料(无论此种材料是否同时用来制成所有固位体或一部分固位体)能够增强缝合线保持就位的能力。一类此种组织接合促进材料是能够挤出以形成缝合线主体的多孔聚合物，包括能够挤出气泡的微孔聚合物和聚合物(可生物吸收的或不可生物吸收的)。用此种材料合成的缝合线可具有三维格子结构，所述结构增大组织接合表面积并允许组织渗透到缝合线主体自身中，从而具有促进成功使用缝合线的主要结构。此外，通过优化孔尺寸可促进成纤细胞向内生长，从而进一步有利于将缝合线锚定在组织中。
一种此类微孔聚合物是ePTFE(膨胀型聚四氟乙烯)。并入ePTFE(和相关的微孔材料)的自固位缝合线很好地适于要求永久强效提升的应用(诸如乳房提升、面部拉皮和其他组织重新定位手术)，这是因为缝合线的组织渗透能够改善缝合线和周围组织的固定和移植，从而提供较优的保持性并延长提升的寿命。
另外，本文所述的自固位缝合线可设置有组合物以促进康复以及防止不期望的影响，例如疤痕形成、感染、疼痛等。这能够以各种方式实现，包括例如：(a)通过将制剂直接附着到缝合线(例如通过用聚合物/药物膜喷雾缝合线，或者通过将缝合线浸渍到聚合物/药物溶液中)；(b)通过将缝合线涂覆有诸如水凝胶的物质，该水凝胶继而吸收组合物；(c)在多细丝缝合线的情况下通过将涂覆有制剂的线(或者聚合物自身形成为线)交织到缝合线结构中；(d)通过将缝合线插入包括或涂覆有制剂的套筒或网片中；或者(e)将缝合线自身构造有组合物。此种组合物可包括但不限于抗增殖剂、抗血管生成剂、抗感染剂、纤维化诱导剂、抗疤痕剂、润滑剂、回波剂、抗炎剂、细胞周期抑制剂、止痛剂和抗微管剂。例如，在形成固位体之前，组合物可施加到缝合线，从而当固位体接合时，接合表面基本上不含涂层。这样，当缝合线被引入时，正被缝合的组织接触缝合线的涂布表面，但当固位体接合时，固位体的非涂布表面接触组织。或者，如果例如期望完全涂覆而不是选择性地涂覆缝合线，那么可在缝合线上形成固位体之后或期间涂覆缝合线。在另一个替代形式中，在形成固位体期间或之后，可通过仅仅将缝合线的选择部分暴露于涂覆可选择性地涂覆缝合线。使用缝合线的具体目的或者组合物可确定是完全涂覆的还是选择性涂覆的缝合线是合适的；例如，对于润滑涂层，可能有利的是选择性地涂覆缝合线，从而使例如缝合线的组织接合表面不涂覆，以防止削弱这些表面的组织接合功能。另一方面，诸如包括这样的化合物作为防传染药剂的那些涂层可以合适地施加到整个缝合线，而诸如包括纤维变性剂的那些涂层可以合适地施加到整个或部分缝合线(例如组织接合表面)。缝合线的目的也可确定涂覆至缝合线的涂层的类型；例如，具有抗增殖涂层的自固位缝合线可用于闭合肿瘤切除部位，而具有纤维化涂层的自固位缝合线可用于组织复位手术并且具有抗疤痕涂层的那些可用于皮肤上的伤口闭合。此外，缝合线的结构可能影响涂层的选择和量值；例如，具有扩展片段的缝合线可在扩展片段上包含纤维变性诱导组合物，以进一步将该片段在组织中固定就位。涂层也可包括共存的或者位于缝合线的不同部分上的多种组合物，其中所述多种组合物可被选择用于不同的目的(例如止痛剂、抗感染剂和抗疤痕剂的组合)或者用于它们的协同效应。
临床应用
除了先前的段落中所述的普通伤口闭合和软组织修复应用之外，自固位缝合线还可用于多种其他适应症。
本文所述的自固位缝合线可用于各种牙科手术，即口腔和上颌面外科手术。上述手术包括但不限于口腔外科手术(如，阻生牙或坏牙的移除)、提供骨扩增的外科手术、修复牙面畸形的外科手术、创伤(如，面部骨折和外伤)后的修复、牙源性和非牙源性肿瘤的外科治疗、重建外科手术、唇裂或腭裂的修复、先天性颅面畸形、以及美容外科手术。自固位牙科缝合线可为降解性的或非降解性的，并且尺寸通常可在USP2-0至USP6-0的范围内。
本文所述的自固位缝合线也可用于组织复位外科手术中。此种外科手术包括但不限于：面部拉皮、颈部提升、前额拉皮、大腿提升和乳房提升。用于组织复位手术中的自固位缝合线可根据被复位的组织而改变；例如，具有较大和较远间隔距离的固位体的缝合线可适用于相对柔软的组织，例如脂肪组织。
本文所述的自固位缝合线也可用于在外科显微镜下进行的显微外科手术中(并且因而可称为“自固位显微缝合线”)。这种外科手术包括但不限于周围神经的重新附接和修复、脊柱显微外科手术、手部显微外科手术、各种塑性显微外科手术(如，面部整形)、男性或女性生殖系统的显微外科手术以及各种类型的重建显微外科手术。当其他选择(例如，原发性闭合、二期愈合、皮肤移植、局部皮瓣转移和远隔皮瓣转移)不足够时，将显微外科重建术用于复杂的重建外科手术问题。自固位显微缝合线具有非常小的口径，通常如USP9-0或USP10-0一样小，并且可具有相应尺寸的附接针。其可为可降解的或非可降解的。
本文所述的自固位缝合线可用于相似小口径范围的眼外科手术中并且因而可称为“眼科自固位缝合线”。这种手术包括但不限于角膜移植术、白内障手术以及玻璃体视网膜显微外科手术。眼科自固位缝合线可为可降解的或非可降解的，并且具有相应小口径的附接针。
自固位缝合线可用于多种兽医应用中，以实现动物健康中的多种外科和外伤目的。
尽管已参照本发明的仅一些示例性实施例来示出和描述本发明，但本领域的技术人员应当理解，这并非旨在将本发明限于所公开的特定实施例。可在不脱离本发明的新颖教导内容和优点的情况下，对本发明所公开的实施例作出各种修改、省略、和添加，尤其是按照上述教导内容。因此，本发明旨在涵盖可包括在由下述权利要求书限定的本发明的实质和范围内的所有此类修改、省略、添加和等同形式。本发明的一些具体实施例为：
一种自固位缝合线，其包括：用于穿透组织的第一端部；具有周边的细长缝合线主体(其可被替代地称为缝合线)；第一多个固位体，其位于所述细长主体(其可被替代地称为缝合线或缝合线主体)的所述周边上并且取向至所述第一端部，所述第一多个固位体在缝合线沿所述第一端部的部署方向运动穿过组织期间朝向缝合线主体屈曲，且抵抗缝合线在组织中沿与第一端部的部署方向基本上相反的方向运动；包括具有可变周长的可变套环的第二端部，其中所述可变套环包括固定套环(其可被替代地称为孔眼)，所述固定套环滑动地接合所述细长主体，用于滑动地改变所述可变套环的所述周长，并且其中所述第一端部可穿过所述可变套环以作为锚定件来固定组织，所述锚定件防止所述缝合线沿所述第一端部的所述部署方向运动。任选地，可使用以下陈述中的一个或多个来进一步描述本文所提供的自固位缝合线：所述第一端部适于穿透组织；所述第一端部附接至针；所述缝合线还在所述细长主体的周边的至少一些上在所述固定套环(孔眼)和所述第一多个固位体之间包括表面结构，所述表面结构抵抗所述固定套环在所述表面特征之上滑动，其中任选地，所述表面结构包括第二多个固位体，所述第二多个固位体远离所述第一端部取向和/或所述表面结构设置于可变套环的周长中的至少一部分中；所述细长主体具有横截面，所述横截面具有横向长度(tl)，且固定套环具有内部横向长度(TL)，并且其中TL：tl的比率为大约1：1至大约10：1，或TL：tl的比率为大约1：1至大约4：1，或TL：tl的比率为大约1：1至大约3：1，或TL：tl的比率为大约1.5：1至大约10：1，或TL：tl的比率为大约1.5：1至大约4：1，或TL：tl的比率为大约2：1至大约3：1；所述固定套环附接至或还包括抓紧接合元件；所述第一多个固位体中的至少一个的构型不同于所述第一多个固位体中的其他固位体；所述第二多个固位体的构型不同于所述第一多个固位体；所述固定套环还包括可视的标记；所述细长缝合线主体(被替代地称为缝合线)的横截面是非圆形的；所述细长缝合线主体的横截面是多边形的；所述缝合线还包括治疗剂。
一种自固位缝合线，其包括：用于穿透组织的第一端部；具有周边和横截面的细长缝合线主体(被替代地称为缝合线)，所述横截面具有横向长度(tl)；第一多个固位体，其位于所述细长主体(被替代地称为细长缝合线主体或缝合线)的所述周边上并且取向至所述第一端部，所述第一多个固位体在缝合线沿所述第一端部的部署方向运动穿过组织期间朝向缝合线主体(被替代地称为缝合线)屈曲，且抵抗缝合线在组织中沿与第一端部的部署方向基本上相反的方向运动；包括具有可变周长的可变套环的第二端部，其中所述可变套环包括固定套环(被替代地称为孔眼)，所述固定套环滑动地接合所述细长主体，用于滑动地改变所述可变套环的所述周长，并且其中所述第一端部可穿过所述可变套环以作为组织中的第三锚定套环来固定组织，以防止所述缝合线沿所述第一端部的所述部署方向运动。
一种自固位缝合线，其包括：用于穿透组织的第一端部；具有周边和横截面的细长缝合线主体，所述横截面具有横向长度(tl)；第一多个固位体，其位于所述细长主体的所述周边上并且取向至所述第一端部，所述第一多个固位体在缝合线沿所述第一端部的部署方向运动穿过组织期间朝缝合线主体屈曲，且抵抗缝合线在组织中沿与第一端部的部署方向基本上相反的方向运动；具有滑结的第二端部，所述滑结包括具有可变周长的套环，所述第一端部可穿过所述套环以作为锚定件来固定组织，以用于防止所述缝合线沿所述第一端部的部署方向运动。
一种自固位缝合线，其包括：用于穿透组织的第一端部；具有周边和横截面的细长缝合线主体，所述横截面具有横向长度(tl)；第一多个固位体，其位于所述细长主体的所述周边上并且取向至所述第一端部，所述第一多个固位体在缝合线沿所述第一端部的部署方向运动穿过组织期间朝向缝合线主体屈曲，且抵抗缝合线在组织中沿与第一端部的部署方向基本上相反的方向运动；具有滑结的第二端部，所述滑结包括具有可变周长的套环，所述第一端部可穿过所述套环以作为组织中的锚定套环来固定组织，以防止所述缝合线沿所述第一端部的部署方向运动。
一种自固位缝合线，其包括：用于穿透组织的第一端部；具有周边和横截面的细长缝合线主体，所述横截面具有横向长度(tl)；第一多个固位体，其位于所述细长主体的所述周边上并且取向至所述第一端部，所述第一多个固位体在缝合线沿所述第一端部的部署方向运动穿过组织期间朝向缝合线主体屈曲，且抵抗缝合线在组织中沿与第一端部的部署方向基本上相反的方向运动；包括具有可变周长的可变套环的第二端部，其中所述可变套环包括具有内部横向长度(TL)的固定套环，并滑动地接合细长主体用于滑动地改变可变套环的周长，其中TL：tl的比率为大约1：1至大约10：1；其中第一端部可穿过所述可变套环以作为锚定件固定组织，所述锚定件用于防止缝合线沿第一端部的部署方向运动。
Claims (13)
1.一种自固位缝合线构型，包括：
a. 第一端部，所述第一端部附接至针且用于穿透组织；
b. 细长缝合线主体，所述细长缝合线主体具有周边；
c. 第一多个固位体，所述第一多个固位体位于所述细长主体的周边上并取向至所述第一端部，所述第一多个固位体在所述缝合线沿所述第一端部的部署方向运动穿过组织期间朝向所述缝合线主体屈曲，并且抵抗当在组织内时所述缝合线沿与所述第一端部的部署方向基本上相对的方向运动；
d. 第二端部，所述第二端部包括具有可变周长的可变套环，其中所述可变套环包括固定套环，所述固定套环滑动地接合所述细长主体，以滑动地改变所述可变套环的周长，并且其中所述第一端部可穿过所述可变套环以作为锚定件来固定组织，所述锚定件防止所述缝合线沿所述第一端部的部署方向运动，
其中所述针的直径大于所述固定套环的直径。
2.根据权利要求1所述的缝合线构型，还包括在所述固定套环与所述第一多个固位体之间在所述细长主体的周边的至少一些上的表面结构，所述表面结构抵抗所述固定套环在所述表面结构之上滑动。
3.根据权利要求1所述的缝合线构型，其中所述细长主体具有横截面，所述横截面具有横向长度，并且所述固定套环具有内部横向长度，并且其中所述内部横向长度与所述横向长度的比率为约1:1至约10:1。
4.根据权利要求1所述的缝合线构型，其中所述固定套环还包括抓紧接合元件。
5.根据权利要求1所述的缝合线构型，其中所述固定套环还包括可视的标记。
6.根据权利要求1所述的缝合线构型，其中所述细长缝合线主体的横截面是非圆形的。
7.根据权利要求1所述的缝合线构型，还包括治疗剂。
8.一种制备自固位缝合线系统的方法，所述方法包括：
a. 提供缝合线，所述缝合线包括部署端部，并且包括或附接至孔眼；
b. 在所述缝合线中形成多个切口，以提供多个组织固位体；
c. 将所述缝合线的部署端部穿过所述孔眼，从而形成具有可变周长的套环；
d. 将所述缝合线的部署端部穿过具有可变周长的所述套环，以提供准备用于包装的缝合线；
e. 将所述准备用于包装的缝合线放置到包装件中，所述包装件适于储存所述缝合线，并适于使临床医生容易地接近所述准备用于包装的缝合线，
还包括在所述部署端部已穿过所述孔眼之后将缝合针附接至所述缝合线的部署端部，其中所述缝合针的直径大于所述套环的直径。
9.根据权利要求8所述的方法，其中在所述部署端部已穿过具有可变周长的所述套环之后将所述缝合针附接至所述缝合线。
10.根据权利要求8所述的方法，其中所述孔眼附接至所述缝合线。
11.根据权利要求8所述的方法，其中所述孔眼通过以下方式形成：
a. 将所述缝合线的非部署端部折回在所述缝合线的部分上，以提供附接区域，其中所述缝合线的所述非部署端部在所述附接区域中与所述缝合线的所述部分接触；以及
b. 在所述附接区域中使所述缝合线的所述非部署端部和所述部分相互附着。
12.根据权利要求11所述的方法，其中所述孔眼包括所述附接区域。
13.根据权利要求11所述的方法，其中所述孔眼邻近所述附接区域。
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108852554A (zh) * | 2018-07-13 | 2018-11-23 | 刘记 | 一种外科整形可降解置入线及缝合设备 |
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| US20120245629A1 (en) | 2012-09-27 |
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| US20200093483A1 (en) | 2020-03-26 |
| CN103889340A (zh) | 2014-06-25 |
| IL228507A0 (en) | 2013-12-31 |
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| JP2014516605A (ja) | 2014-07-17 |
| RU2659454C2 (ru) | 2018-07-02 |
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