CN103068324A - 具有激光切割固位刺的自固位系统 - Google Patents
具有激光切割固位刺的自固位系统 Download PDFInfo
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Abstract
本发明公开了自固位缝线系统,所述自固位缝线系统包括具有多个激光切割固位刺的缝合线。一种激光系统可用于产生固位刺和自固位缝线系统,所述固位刺和自固位缝线系统具有难以和/或不可能用常规机械切割工艺实现的构型。
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2010年5月4日提交的美国临时专利申请No.61/331,294和2010年5月4日提交的美国临时专利申请No.61/331,302的优先权,这两个专利申请全文以引用方式并入本文。
技术领域
本发明一般地涉及用于外科手术的自固位系统、用于外科手术的自固位系统的制造方法及其使用。
背景技术
诸如缝线、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接在一起、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(固定医疗植入物、装置、假体和其他功能性或支承性装置)、以及用于将组织重新设置到新解剖位置(修复、组织抬升、组织移植和相关手术)等等。
缝线通常用作伤口闭合装置。缝线通常由附接至具有尖端的缝合针的丝状缝合线组成。缝合线可由多种材料制成,所述材料包括生物吸收性(即,在体内随时间推移而完全分解)或非吸收性(永久性的;非降解性的)材料。已经发现的是,吸收性缝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线材料提供的支承成为无用的;如(例如)在完成不复杂的皮肤缝合中。非降解性(非吸收性)缝线用于下述伤口中:愈合可预期会扩张或者缝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、多种矫形修复和一些类型的外科吻合中。另外,可获得多种外科用缝合针;缝合针主体的形状和尺寸以及缝合针尖端的构型通常是基于特定应用的需要进行选择的。
为了使用普通缝线,将缝合针在伤口的一侧推进穿过所需组织并且随后穿过伤口的相邻侧。然后将缝线形成“环”以将伤口保持为闭合的,所述“环”是通过在缝线中打结实现的。打结需要时间并且会导致一系列并发症,所述并发症包括(但不限于)(i)泌液(其中缝线(通常为结)在皮下闭合之后穿过皮肤的症状)、(ii)感染(细菌通常能够在由结产生的空间内附接和生长)、(iii)团块/肿块(留在伤口中的显著量的缝线材料为构成结的部分)、(iv)滑脱(结可滑动或变为松开的)和(v)刺激(结充当伤口中的团块“异物”)。与打结相关的缝线环可导致缺血(结可产生可压缩组织并限制流到该区域的血流的张力点)并且可导致外科伤口处裂开或破裂的风险增加。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的花费为在$15和$30之间)。
自固位缝线(包括倒刺缝线)与常规缝线的区别在于自固位缝线具有若干组织固位刺(例如倒刺),所述组织固位刺将自固位缝线在调配之后锚固到组织内并且抵制缝线沿与固位器所面对方向相反的方向进行移动,从而无需打结以将相邻组织附连在一起(“无结”闭合)。具有倒刺的无结组织拉近装置先前已在(例如)美国专利No.5,374,268中有所描述,该专利公开了具有倒刺状凸起的带臂锚固体,而具有倒刺侧向构件的缝线组件已在美国专利No.5,584,859和No.6,264,675中有所描述。具有沿缝线的较大部分设置的多个倒刺的缝线在美国专利No.5,931,855(其公开了单向倒刺缝线)和美国专利No.6,241,747(其公开了双向倒刺缝线)中有所描述。用于在缝线上形成倒刺的方法和设备已在(例如)美国专利No.6,848,152中有所描述。用于伤口闭合的自固位系统还导致较好的伤口边缘拉近、均匀地分布沿伤口长度的张力(减少可断裂或导致缺血的张力面积)、减小保留在伤口中的缝线材料的团块(通过消除结)、以及减少泌液(缝线材料(通常为结)挤出穿过皮肤表面)。相对于使用普通缝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,由于自固位缝线无需打结,这种缝线允许患者经受改善的临床结果,并且还节约与长期手术和随访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。
相比于普通缝线,自固位缝线的下述能力也提供优越性,即,甚至在不存在由结施加至缝线的张力的情况下将组织锚固和保持在适当位置。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)自固位缝线具有多个固位刺,从而相比于将张力集中在分立点处的带结间断缝线而言可分散沿缝线的整个长度的张力(通过提供数百个“锚固”点来提供优异的美容效果并且降低缝线将“滑脱”或拉出的机率);(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)且可实现比间断缝线更高的精确度和准确度;(iii)自固位缝线无需“第三手”,而在常规的缝合和打结过程中通常需要“第三手”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)自固位缝线可用于在定形闭合之前来拉近和保持伤口。因此,自固位缝线在解剖学上紧密或深部的位置(例如骨盆、腹部和胸腔)中提供较容易的处理并且使得较易于在腹腔镜式/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伤口。较高的精确度允许自固位缝线用于比利用普通缝线可实现的更复杂的闭合(例如,具有直径失配、较大缺损或缩拢线缝合的那些)。
自固位缝线可为单向的,从而在缝合线的长度上具有沿一个方向取向的一个或多个固位刺;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刺、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刺(如结合美国专利No.5,931,855和No.6,241,747中的倒刺固位刺所述)。尽管可使用任意数量的固位刺的连续或间断构型,但一种形式的单向自固位缝线包括位于远端的组织锚固体和位于近端的缝合针以及位于缝合线表面上的多个倒刺,所述倒刺具有“远离”缝合针突出的尖端。“远离”缝合针突出是指倒刺的尖端更加远离缝合针并且包括倒刺的缝线部分可在缝合针的方向上相比于相反方向(朝向组织锚固体)更易于穿过组织。组织锚固体被设计为固定缝线的远端并且在一些实施例中包括环、缝钉、平头钉、条、栓、片材或球。
尽管可使用任意数量的固位刺的连续或间断构型,但一种形式的双向自固位缝线包括位于缝合线一端处的缝合针,所述缝合线具有倒刺,所述倒刺具有“远离”缝合针突出的尖端直至达到缝线的过渡点(通常中点);在过渡点处,倒刺的构型使其自身沿缝合线的剩余长度翻转约180°(使得倒刺目前面向相反方向),随后附接至在相对端处的第二缝合针(结果是缝线此部分上的倒刺也具有“远离”最近缝合针突出的尖端)。换句话讲,普通双向自固位缝线的两个“半部”上的倒刺均具有指向中点的尖端,其中过渡区段(不含倒刺)散置在两个“半部”之间并且缝合针附接至任一末端。
发明内容
尽管单向和双向自固位缝线具有多个优点,但仍需要改善缝线的设计,使得可消除多种限制并且提供增强和/或附加的功能。
另一方面,本发明提供了适于在缝合线上用激光切割的固位刺设计。
另一方面,本发明提供了具有多个激光切割固位刺的缝合线。
另一方面,本发明提供了具有多个激光切割固位刺的单向自固位缝线系统。
另一方面,本发明提供了具有多个激光切割固位刺的双向自固位缝线系统。
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、附图和权利要求书,其他特征、目的和优点将显而易见。
另外,本文引用的所有专利和专利申请的公开内容均全文以引用方式并入,这些专利和专利申请包括:2008年4月11日提交的名称为“SELF-RETAINING SYSTEMS FOR SURGICAL PROCEDURES”(用于外科手术的自固位系统)的美国专利申请No.12/101,885;2009年2月25日提交的名称为“ALTERNATIVE GEOMETRY SELF-RETAINING SUTURESSYSTEM”(非传统几何形状的自固位缝线系统)的美国专利申请No.12/392,939;2008年12月19日提交的名称“SELF-ReTAINING SUTURESWITH RETAINERS FORMED FROM MOLTEN MATERIALS”(具有由熔融材料形成的固位刺的自固位缝线)的美国专利申请No.12/340,444;以及______提交的美国专利申请No.(______代理人参考编号No.2284.40852USPC),其为2011年5月4日提交的名称为“LASERCUTTING SYSTEM AND METHODS FOR CREATING SELF-RETAININGSUTURES”(用于形成自固位缝线的激光切割系统和方法)的国际专利申请No.______(代理人参考编号No.2284.40852PC)的美国国家阶段。
附图说明
根据附图和以下对各个实施例的详细描述,本发明的特征、其本质和各种优点将显而易见。
图1A为根据本发明的实施例的双向自固位缝线的透视图。
图1B-1D为图1A的缝线的部分的放大视图。
图1E为根据本发明的实施例的单向自固位缝线的透视图。
图1F-1H为用于根据本发明的替代实施例的图1E的单向自固位缝线的可供选择的组织锚固体的视图。
图2A示出了适于在缝合线上形成固位刺的激光加工系统的示意图。
图2B为高斯激光束的影像。
图2C为高斯激光束中的功率密度分布的图示。
图2D为得自轴锥镜系统的激光束的影像。
图2E为得自轴锥镜系统的激光束中的功率密度分布的图示。
图3A示出了用于图2的激光加工系统中的空气轴承的剖面图。
图3B示出了图3A的空气轴承的局部透视图。
图4A为用于利用图2的激光加工系统产生自固位缝线的方法的流程图。
图4B-4D为在利用图2的激光加工系统产生激光切割固位刺的过程中的缝合丝线的透视图。
图5A-5H示出了可利用根据本发明的实施例的图2的激光加工系统产生的可供选择的激光切割固位刺的构型。
图6A-6C为一种丝线的剖面图、透视图和影像,所述丝线上具有通过使用根据本发明的实施例的图2的激光加工系统的替代性减材料法形成的激光切割固位刺。
图6D为采用参照图6A-6C所述的减材料设计的自固位缝线的替代设计的局部剖切视图。
图6E和6F为采用参照图6A-6C所述的减材料设计的自固位缝线的替代设计的剖面图和透视图。
图7A-7C示出了利用根据本发明的实施例的图2的激光加工系统制备的自固位缝线的固位刺分布构型。
图8A-8F示出了利用根据本发明的实施例的图2的激光加工系统制备的自固位缝线的实例。
图8G-8J示出了利用根据本发明的实施例的图2的激光加工系统制备的自固位缝线以及自固位缝线的测量的实例。
图9A为表示对于利用根据本发明的实施例的图2的激光加工系统制备的原型自固位缝线的机械测试结果的表。
图9B为自固位缝线的激光切割表面的影像。
图9C为示出图9B的激光切割表面的轮廓的曲线图。
具体实施方式
定义
可在下文中使用的某些术语的定义包括如下内容。
“自固位系统”是指与用于将缝线调配到组织内的装置相结合的自固位缝线。这种调配装置包括(但不限于)用于穿透组织的缝合针和其他调配装置以及缝线自身上的足够刚性和尖锐的末端。
“自固位缝线”是指下述缝线,其包括位于缝合丝线上的用于接合组织的特征,从而无需结或缝线锚固体。
“组织固位刺”(或简称“固位刺”)或“倒刺”是指缝合丝线的下述物理特征,所述物理特征适于机械性地接合组织并且抵制缝线沿至少一个轴向方向的移动。仅以举例的方式,组织固位刺或固位刺可包括钩、突出物、倒刺、缝摺、延伸件、凸起、锚固体、隆起物、刺、凸块、尖点、齿、组织衔接体、牵引装置、表面粗糙体、表面不规则体、表面缺陷、边缘、小平面等等。在某些构型中,组织固位刺通过被取向为基本上面向调配方向而适于接合组织以抵制缝线沿下述方向的移动,所述方向不同于医生将缝线调配到组织内的方向。在一些实施例中,固位刺在沿调配方向进行牵拉时为平展设置的并且在沿与调配方向相反的方向进行牵拉时打开或“扇出”。当每一个固位刺的组织穿透端在调配期间背向调配方向以移动穿过组织时,组织固位刺不应在此阶段捕获或抓取组织。一旦自固位缝线已得到调配时,沿另一个方向(通常基本上与调配方向相反)施加的力就使得固位刺从调配位置(即,基本上沿缝线主体设置)移位、促使固位刺末端以捕获且穿透到周围组织内的方式从缝线主体打开(或“扇出”)、并且导致组织被捕获在固位刺和缝线主体之间;从而将自固位缝线“锚固”或附接至适当位置。在某些其他实施例中,组织固位刺可被构造为允许缝线沿一个方向移动并且抵制缝线沿另一个方向移动且不存在扇出或调配。在某些其他构型中,组织固位刺可结合其他组织固位刺进行构造或组合以抵制缝合丝线沿两个方向的移动。通常,将具有这些固位刺的缝线调配穿过诸如套管之类的装置,从而避免固位刺和组织间的接触直至缝线处于所需位置。
“固位刺构型”是指组织固位刺的构型并且可包括如下特征,例如尺寸、形状、柔韧性、表面特性等等。这些构型有时也称为“倒刺构型”。
“双向缝线”是指下述自固位缝线,所述自固位缝线在一端处具有沿一个方向取向的固位刺并且在另一端处具有沿另一个方向取向的固位刺。双向缝线通过在缝合线的每一个末端处通常配备有缝合针。多种双向缝线具有设置在两种倒刺取向之间的过渡区段。
“过渡区段”是指位于沿一个方向取向的第一组固位刺(倒刺)和沿另一个方向取向的第二组固位刺(倒刺)之间的双向缝线的不含固位刺(不含倒刺)部分。过渡区段可位于约自固位缝线的中点附近或者较靠近自固位缝线的一端以形成非对称自固位缝线系统。
“缝合线”是指缝线的细丝主体部件;缝合线可为单丝的或者包括多丝(如在编织缝线中)。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,以用于增强缝线的强度、弹性、寿命或其他特性,或者用于配置缝线,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。
“单丝缝线”是指包括单丝缝合线的缝线。
“编织缝线”是指包括多丝缝合线的缝线。这种缝合线中的丝线通常编织、拧绕或针织在一起。
“降解性缝线”(也称为“生物降解性缝线”或“吸收性缝线”)是指在引入到组织内之后被身体分解和吸收的缝线。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和单体的断链过程。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。降解性缝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(如,MAXONTM、Covidien),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(如,BIOSYNTM[乙交酯(60%)、三亚甲基碳酸酯(26%)和二氧环己酮(14%)]、Covidien),乙交酯、己内酯、三亚甲基碳酸酯和丙交酯的共聚物(如,CAPROSYNTM、Covidien)。溶解性缝线还可包括部分脱乙酰的聚乙烯醇。适用于降解性缝线的聚合物可为直链聚合物、支链聚合物或多轴聚合物。用于缝线中的多轴聚合物的实例在美国专利申请公开No.2002/0161168、No.2004/0024169和No.2004/0116620中有所描述。由降解性缝线材料制成的缝线在该材料降解时会损耗拉伸强度。降解性缝线可呈编织多丝形式或单丝形式。
“非降解性缝线”(也称为“非吸收性缝线”)是指包含下述材料的缝线,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(如,聚对苯二甲酸乙二醇酯)、聚四氟乙烯(如,膨胀型聚四氟乙烯)、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(如,不锈钢丝)、聚丙烯、聚乙烯、丝线和棉线。由非降解性缝线材料制成的缝线适用于其中缝线旨在永久性地保留或者旨在从身体物理地移除的应用。
“缝线直径”是指缝线主体的直径。应当理解,本文所述的缝线可使用多种缝线长度,并且尽管术语“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。缝线定径取决于直径。缝线尺寸的美国药典(“USP”)标示为较大范围内的0至7和较小范围内的1-0到11-0;在较小范围内,-0之前的数值越大,则缝线直径越小。缝线的实际直径将取决于缝线材料,以使得(以举例的方式)具有尺寸5-0并且由胶原构成的缝线将具有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线将各自具有0.1mm的直径。针对特定目的选择的缝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;尽管较小的缝线可能更易于操纵穿过紧密外科部位并且与较小疤痕相关,但由给定材料制备的缝线的拉伸强度往往会随尺寸减小而降低。应当理解,本文所公开的缝线和制备缝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。
“缝合针附接”是指将缝合针附接至需要所述缝合针以用于调配到组织内的缝线并且可包括下述方法,例如卷曲、旋压、使用粘合剂等等。利用诸如卷曲、旋压和粘合剂之类的方法将缝合线附接至缝合针。缝线和外科用缝合针的附接操作在美国专利No.3,981,307、No.5,084,063、No.5,102,418、No.5,123,911、No.5,500,991、No.5,722,991、No.6,012,216和No.6,163,948、以及美国专利申请公开No.US 2004/0088003中有所描述。缝线与缝合针的附接点称为旋压点。
“缝合针”是指用于将缝线调配到组织内的缝合针,所述缝合针采用多种不同的形状、形式和组成。存在两种主要类型的缝合针:有创缝合针和无创缝合针。有创缝合针具有沟槽或钻孔末端(即,针孔或针眼),独立于缝合线来提供,并且进行现场接线。无创缝合针为无针眼的并且在工厂处通过旋压或其他方法附接至缝线,借此将缝线材料插入到在缝合针钝端处的沟槽内,随后使所述沟槽变形至最终形状以将缝线和缝合针保持在一起。这样,无创缝合针在现场无需额外的时间来接线并且在缝合针附接位点处的缝线端通常小于缝合针主体。在有创缝合针中,线从缝合针孔两侧引出并且通常缝线在穿过组织时会将组织撕裂至某种程度。大多数现代缝线为旋压的无创缝合针。无创缝合针可永久性地旋压至缝线或者可被设计为利用迅速直接的拉拽除去缝线。这种“拽断点”通常用于间断缝线中,其中每一条缝线仅穿过一次并且随后进行打结。对于不间断的倒刺缝线而言,这些无创缝合针为优选的。
另外可根据缝合针的末端或尖端的几何形状来对缝合针分类。例如,缝合针可为(i)“锥形的”,从而缝合针主体为圆形的并且平滑地渐缩至尖端;(ii)“切割的”,从而缝合针主体为三角形的并且具有位于内侧上的尖锐切割边缘;(iii)“反向切割的”,从而切割边缘位于外侧上;(iv)“套管针点”或“锥形切口”,从而缝合针主体为圆形和锥形的,但末端位于小的三角切割点中;(v)“钝”点,以用于缝合脆性组织;(vi)“侧面切割”或“刮刀点”,从而缝合针在顶部和底部上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。
缝合针在(例如)以下美国专利中有所描述:No.6,322,581;No.6,214,030;No.5,464,422;No.5,941,899;No.5,425,746;No.5,306,288;No.5,156,615;No.5,312,422;和No.7,063,716。其他缝合针在(例如)以下美国专利中有所描述:No.6,129,741;No.5,897,572;No.5,676,675;和No.5,693,072。可利用多种缝合针类型(包括(但不限于)弯曲的、直的、长的、短的、微小的等等)、缝合针切割表面(包括(但不限于)切割的、锥形的等等)和缝合针附接技术(包括(但不限于)钻孔末端、卷曲的等等)来调配本文所述的缝线。此外,本文所述的缝线自身可包括足够刚性和锐利的末端,以便完全免除用于调配缝合针的需求。
“缝合针直径”是指缝线调配缝合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。
“配备的缝线”是指下述缝线,其中在至少一个缝线调配末端上具有缝合针。“缝线调配末端”是指有待调配到组织内的缝线的末端;缝线的一个或两个末端均可为缝线调配末端。缝线调配末端可附接至调配装置(例如缝合针),或者可为足够锐利和刚性的以靠自身来穿透组织。
“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:诸如刺穿、跌倒或外科手术之类的动作;传染病;或潜在医学病症。外科伤口闭合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。闭合可起到功能目的和美学目的两者的作用。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使疤痕的形成最小化、以及通过皮肤边缘的精确外翻来避免凹陷疤痕。
“组织抬升手术”是指将组织从较低高度重新设置到较高高度的外科手术(即,沿着与重力方向相反的方向移动组织)。面部的保持韧带将面部软组织支承在正常解剖位置。然而,随着年龄的增长,组织体积的重力效应和损耗导致组织的向下迁移,并且脂肪会下降到表浅和深部面部筋膜之间的平面内,从而导致面部组织松垂。除褶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:随时间推移的老化和重力的效应、以及导致组织松垂的其他时间效应,例如遗传效应。应当注意,组织也可在不进行抬升的情况下进行重新设置;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)进行重新设置以便恢复对称性(即,重新设置,使得身体的左侧和右侧“匹配”)。
“医疗装置”或“植入物”是指为了恢复生理功能、减轻/缓和疾病相关症状和/或修复和/或替换损坏的或病态的器官和组织而设置在体内的任何物体。尽管医疗装置和植入物通常由外源性的生物相容性合成材料(如,医学级不锈钢、钛和其他金属或聚合物,例如聚氨酯、硅、PLA、PLGA和其他材料)构成,但一些医疗装置和植入物包括源自动物的材料(如,“异种移植物”,例如整个动物器官;动物组织,例如心瓣膜;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)矫形外科植入物(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)等等。
激光切割自固位缝线
如上文所述,本发明提供了具有激光切割固位刺的自固位缝线、制造这种缝线的方法、以及在外科手术中使用这种缝线的方法,使得可消除多种限制并且提供增强和/或附加的功能。图1A示出了激光切割自固位缝线系统100。自固位缝线系统100包括附接至自固位缝合线102的缝合针110、112。自固位缝合线102包括分布在丝线120的表面上的多个固位刺130。在丝线120的引入部分140中,不存在固位刺130。在丝线120的部分142中,存在多个固位刺130,所述固位刺130被设置为使得可沿缝合针110的方向来调配缝线、但抵制沿缝合针112的方向的移动。在过渡部分144中,不存在固位刺130。在部分146中,存在多个固位刺130,所述固位刺130被设置为使得可沿缝合针112的方向来调配缝线、但抵制沿缝合针110的方向的移动。在丝线120的引入部分148中,不存在固位刺130。在部分140、142、144、146和148中的每一个中示出了中断,以指示每一个部分的长度可根据旨在使用缝线的应用进行改变和选择。例如,如果需要,过渡部分144可非对称地设置为更靠近缝合针110或缝合针112。
自固位缝线系统100由两个臂构成。每一个臂可视为自固位缝线系统100的一部分。第一臂包括自固位缝合线102的部分142和部分140,并且弯曲缝合针110具有适于接合较硬/较致密组织的相对小的固位刺。第二臂包括自固位缝合线102的部分146和148以及缝合针112。
尽管图1A的自固位缝线系统100具有两个臂,但在可供选择的实施例中,自固位缝线系统具有单臂缝线;双臂缝线;三臂缝线;多臂缝线;其中缝线的两个或更多个部分具有不同特征的杂功能缝线;在每一个末端上具有不同类型(或尺寸)的缝合针的双臂缝线;可用于不同层/深度和类型的组织的单臂或双臂缝线;其中丝线部分具有不同直径以用于不同层/深度和类型的组织的单臂或双臂缝线。
固位刺130为通过利用下述激光器切割和/或烧蚀丝线的部分而形成在丝线120的表面上的激光切割固位刺。在一些实施例中,固位刺130彼此相同。在可供选择的实施例中,固位刺130在自固位缝合线102的不同部分中和/或各个部分内具有不同的形状、尺寸和/或分布,以最佳地适用于接合组织。具有激光切割固位刺的自固位缝线系统的优点在于,其适于利用将在下文所述的单个切割装置在缝合线上产生多种固位刺构型。
图1B示出了部分142中的自固位缝合线102的放大视图。如图1B所示,多个固位刺130分布在丝线120的表面上。自固位缝线在调配到组织内之后的附接需要固位刺末端132穿透到周围组织内,从而导致组织被捕获在固位刺130和缝合丝线120的主体之间。接触被捕获在固位刺130和缝合丝线120的主体之间的组织的固位刺130的内表面134在本文中称为“组织接合表面”或“内固位刺表面”。如图1B所示,每一个固位刺130具有尖端132和组织固位刺表面134。当自固位缝合线102沿箭头136的方向移动时,固位刺130紧靠丝线120的主体平展地设置。然而,当自固位缝合线102沿箭头138的方向移动时,固位刺130的尖端132接合围绕丝线120的组织并且导致固位刺130从丝线120扇出且利用组织接合表面134来接合组织,从而阻止缝线沿该方向的移动。
图1C示出了部分144中的自固位缝合线102的放大视图。如图1C所示,在部分144中,不存在固位刺130。部分144可称为自固位缝线系统100的过渡部分。部分144可沿着由箭头136和138示出的方向中的任一者或两者进行调配。在许多手术中,希望定位过渡区域以便在缝线调配开始时适当地设置过渡区域。因此,在一些实施例中,部分144中的丝线120设置有可识别特征。例如,如图1A和1C所示,自固位缝线系统100的部分144设置有形式为可见条带150的可识别标记物。条带150表示丝线120的下述部分,所述部分具有不同于丝线120的其他部分的可见特征,从而可被医生识别出,以便识别和定位自固位缝线系统100的过渡部分144。在可供选择的实施例中,将标记物设置在丝线的其他部分和/或缝合针上以便识别与所标记部分相关的自固位缝线系统的特征。另外,标记物差异可包括不同形状、不同颜色、不同数字和不同的字母,仅以标记物的这些类型为例。
图1D示出了部分146中的自固位缝合线102的放大视图。如图1D所示,多个固位刺130分布在丝线120的表面上。如图1D所示,每一个固位刺130具有尖端132和组织固位刺表面134。当自固位缝合线102沿箭头138的方向移动时,固位刺130紧靠丝线120的主体平展地设置。然而,当自固位缝合线102沿箭头136的方向移动时,尖端132或固位刺130接合围绕丝线120的组织并且导致固位刺130从丝线120扇出且利用表面134来接合组织,从而阻止缝线沿该方向的移动。因此,在部分146中,固位刺130沿着与部分142中的固位刺130相反的方向进行取向。
图1E示出了自固位缝线系统160的可供选择的实施例。自固位缝线系统160包括图1A的自固位缝线系统100的缝合针110以及部分140、142和144。然而,自固位缝线系统160为单臂系统。如图1E所示,丝线120端接组织锚固体114e中的后续部分146。组织锚固体114e为用于接合组织并且阻止丝线120沿缝合针110的方向移动穿过组织的装置。在一些实施例中,组织锚固体114e与丝线120一体地形成或者单独地形成并且随后附接至丝线120。如图1E所示,组织锚固体114e具有大约垂直于丝线120的轴线延伸的棒形主体170e。棒形主体170e为足够长的和足够刚性的,以在组织锚固体114e已接合组织之后阻止丝线120沿缝合针110的方向的移动。
图1F示出了可取代图1E的组织锚固体114e使用的替代锚固体114f。如图1F所示,组织锚固体114f包括锥形主体170f。锥形主体170f具有尖端172f和组织接合特征174f,所述组织接合特征174f由肋和/或倒刺组成。组织锚固体114f被构造为推压到组织内以便将丝线120锚固至该组织并且阻止丝线120沿缝合针110的方向的移动。
图1G示出了可取代图1E的组织锚固体114e使用的替代锚固体114g。如图1G所示,组织锚固体114g包括套环170g。在此实施例中,套环170g是通过如下方式形成的:向后折叠丝线120的末端172g并且将末端172g通过焊接、熔合和/或粘合剂固定至丝线120。套环170g因而由丝线120的材料形成。套环170g具有小孔174g,缝合针110可穿过所述小孔174g以便产生套索,所述套索可用于接合组织并且阻止丝线120沿缝合针110的方向的移动。
图1H示出了可取代图1E的组织锚固体114e使用的替代锚固体114h。如图1H所示,组织锚固体114h包括肘钉形主体170h。丝线120穿过锚固体114h中的小孔并且通过卷曲部174h进行固定。肘钉形主体170h具有两个尖端172h,所述两个尖端172h可朝向彼此变形以接合组织并且阻止丝线120沿缝合针110的方向的移动。
用于产生自固位缝线的激光加工系统
在本发明的实施例中,使用激光加工系统来产生缝合线表面上的固位刺和/或形成缝合线上的可见标记物。激光加工系统使用聚焦相干光束来从缝合线选择性地切割和/或烧蚀材料以在缝合线上产生具有所需构型的固位刺。切割/烧蚀过程为非接触式过程。合适的激光加工系统具有非常高的空间禁闭和控制并且对缝合线具有非常低的热沉积以便避免在固位刺形成期间对缝合线产生损害。
通常,激光加工系统用于将激光束施加至缝合线内的一定体积的材料。激光能量被材料吸收,从而所述材料被汽化和移除。在一些实施例中,缝合线具有促进激光能量的吸收的组分。提供选定功率、波长和脉冲宽度的激光以汽化选定体积的缝线材料且不会损害剩余的缝合线。激光的波长通常在UV到可见光到红外光的范围内。本文所用的光并不限于可见光谱。选择理想的波长或波长谱以实现最佳的切割/烧蚀特性。
引起烧蚀/切割所需的照射可在一个连续照射或多个脉冲中完成。多个激光脉冲的照射允许每一个激光脉冲的能量耗散并且因此相比于相同总时间长度的一个连续脉冲在缝合线中导致较低的温升。控制激光束的功率和/或脉冲宽度以切割/烧蚀所需材料同时递送至周围材料的总能量不足以不利地影响缝合线的整体材料特性。例如,在一个优选的实施例中,使用飞秒激光器,所述飞秒激光器针对极短持续时间的激光脉冲提供高功率。另外控制波长、功率、焦距和/或脉冲宽度以实现激光到缝合线内的所需穿透。
可使用多种不同的激光器和控制系统以将激光导向缝线的所需位置,以产生固位刺。在一些实施例中,使用受控光束系统以实现所需的切割/烧蚀。在受控光束系统中,将脉冲激光导向缝合线上的移动点。使用安装在计算机控制型检流计上的反射镜来将激光束导向缝合线的目标体积。在可供选择的实施例中,使用掩模或其他光学件产生成形激光束,所述成形激光束具有合适的形状以用于实现所需的切割/烧蚀。在可供选择的实施例中,使用步进式模式产生激光标记。通过调节激光器的启闭来定向和烧蚀/切割缝线材料的体积。然后移动缝线和/或激光以将新目标体积与激光对准,并且通过调节激光器的启闭来烧蚀/切割新目标。继续进行该过程以步进式地导向光束或步进式地移动缝合线,直至实现所需的固位刺构型。
图2A为适用于制备自固位缝线的激光加工系统的示意图。如图2A所示,激光加工系统200包括五个子系统。激光加工系统200的五个子系统为激光子系统210、光学子系统220、成像子系统230、传送子系统240和控制子系统250。激光子系统210将激光功率以激光束202形式提供至激光加工系统200。激光子系统210受控制子系统250的控制。激光子系统210包括激光器212、激光衰减器214和激光匀化器216。激光器212产生激光束202。激光衰减器214调节激光束202,从而允许其按照需要在控制子系统250的控制下穿过和受阻。激光匀化器216改进激光束202以在整个激光束202上产生均一功率密度。
在一个优选的实施例中,激光子系统210为飞秒激光系统。飞秒激光系统提供适用于从缝合线切割/烧蚀材料的激光能量的超短脉冲,其具有高精确度且不会对周围缝合线造成损害。通过使用飞秒激光脉冲,经由材料的光学吸收以及随后的雪崩电离来将激光能量沉积到材料的小体积内。在下述时标下来沉积激光能量,所述时标远远短于用于材料中的热传输的时标。因此,激光束靶向的材料从固相转变成汽相和等离子体形成物,此过程为几乎瞬时完成的并且不会对周围材料产生显著的热传递。飞秒激光脉冲因此降低对缝合线的热损害。
飞秒激光为有利的,因为其可实现:完全自动化系统中的高分辨率和可重复性;用于缝合线的切割/烧蚀的高纵横比且具有烧蚀材料的低再沉积率;切割/烧蚀区域附近的缝合线的非常局部化的效应和极小损害;以及宽泛的材料和直径范围(包括,例如USP 12-0至7)上的缝合线材料的有效切割。例如,飞秒激光系统可切割/烧蚀缝线材料,其中切割表面具有亚微米分辨率和纳米级表面粗糙度。可调节飞秒激光器的参数以实现所需分辨率、纵横比并且降低伴行损害,包括通过选择:适当的波长或波长组合;光束的能量分布(高斯、方波、轴锥镜分布);光束能量和脉冲宽度;以及光学系统的焦距和焦深。在一些情况下对这些参数进行修改以用于不同的缝合线材料和直径以及固位刺构型。
激光束202从激光子系统210穿行至光学子系统220。光学子系统220包括用于将激光束202导向和/或聚焦至所需靶的一个或多个反射镜222和透镜。具体地讲,光学子系统220包括物镜224,激光束202从物镜224离开光学子系统220射向所需靶。光学子系统220还包括一个或多个致动器226、228,所述致动器226、228受计算机子系统250控制以用于调节反射镜222和透镜224的位置。
成像子系统230允许观察缝合线204和监测其上的激光加工结果。成像子系统230包括在一些实施例中为相机的成像装置232。成像系统还包括用于照射缝合线120的照射装置234。成像子系统230还可包括用于将光导向缝合线202和从缝合线202导向光的一个或多个反射镜和透镜。成像子系统230将缝合线204的影像提供至控制子系统250。在一个优选的实施例中,成像子系统230设置为与光学子系统220成一直线,如图所示。也就是说,照射装置234将照射光递送至缝合线204并且成像装置232通过光学子系统220来接收缝合线204的影像。控制子系统250可使用缝合线204的影像来确认激光子系统210和光学子系统220的操作是否正确并且根据需要作出构型调整。有利的是,控制子系统250可使用得自成像子系统230的影像数据来监测和调整光学系统的焦深,以允许激光束的适当聚焦和靶向。在可供选择的实施例中,可使用离线成像系统。缝合线204的影像也可用于固位刺形成物的质量控制,在一些实施例中包括用于确认固位刺的100%的正确产生率。
传送子系统240操作以支承缝合线204并且相对于激光束202来移动缝合线204。激光子系统210、成像子系统230、光学子系统220和传送子系统240均牢固地安装至工作台206以避免系统的相对移动/振动,其中由传送子系统240控制的相对移动/振动除外。传送子系统240包括用于固定缝合线204的每一个末端的卡盘242。卡盘242优选由致动器243来驱动,所述致动器243驱动缝合线204围绕缝合线204的纵向轴线旋转。卡盘242安装至XY定位台244、246上。XY定位台244、246优选由致动器245、247来驱动,所述致动器245、247控制缝合线204相对于激光束202的位置。XY定位台244、246优选与缝合线204的纵向轴线对准,使得一个台控制缝合线沿其纵向轴向相对于激光束202的移动并且另一个台控制缝合线204垂直于纵向轴线的移动(横穿激光束204)。致动器243、245、247优选受控制子系统250的控制。在一些实施例中,传送子系统240包括如下缝线线轴和机构(未示出),所述缝线线轴和机构用于自动地馈送有待保持在卡盘242之间的缝合线的长度,且无需缝合线的重新穿线。
传送子系统240还包括用于将缝合线204固定到激光束202附近的稳定装置248。稳定装置248降低切割区域附近的缝合线204的移动以便提高激光加工操作的精确性。在优选的实施例中,稳定装置248为空气轴承,所述空气轴承提供空气流以稳定缝合线204且无需机械性地接触缝合线204。空气流还起到冷却缝合线204和除去来自切割区域的烟尘和粒子的作用。
控制子系统250为通用机器控制系统,所述通用机器控制系统具有用于控制致动器的输出和用于接收得自机器传感器的数据的输入。控制子系统250包括用于程序和数据储存的存储器。程序和数据储存包括用于激光子系统210、光学子系统220、成像子系统230和传送子系统240的操作的参数和/或有关激光加工系统200的操作的经记录的诊断和性能数据。可将数据储存在控制子系统250或者与局域网或WAN相关的其他数据储存器中。可将数据以单一格式或多种格式来保存。可将数据储存在单一类型的介质上或多种类型的介质上,如,硬盘、RAM、闪速存储器、软盘、Web存储系统等。
控制子系统250包括可为计算机处理器、CPU的一个或多个处理器252,并且通常包括专门设计用于控制激光加工系统200的微控制器、CPU、微处理器或者等效控制电路或处理器,并且还可包括RAM或ROM存储器、逻辑和定时电路、状态机电路和I/O电路。控制系统包括和/或具有程序和/或数据的入口,所述程序和/或数据定义将形成于丝线上的固位刺的分布和将形成于丝线上的固位刺的形状以及固位刺的预期形状的公差。控制子系统250的设计细节对于本发明并非至关重要的。相反,可使用任何合适的控制子系统250来执行本文所述的功能。用于控制机器工具的基于计算机/微处理器的控制系统的使用在本领域中为熟知的。
在一个实施例中,由激光子系统210和光学子系统220提供的激光束具有高斯功率密度分布。图2B示出了入射到平表面268上的高斯激光束260的代表性影像。如图2B所示,当远离光束260的中心262处的峰移动时,高斯光束260的功率密度迅速下降。可利用光学子系统来聚焦激光束以改变峰值功率密度区域的直径D。图2C示出了高斯激光束(例如图2B的激光束260)的功率密度分布的图示。
可通过使用两个轴锥镜(绕轴旋转体棱镜)和一个透镜的轴锥镜系统来实现另一种激光束形状/功率分布。第一轴锥镜产生环,透镜将该环聚焦至薄的(5微米)宽度,并且第二轴锥镜准直该环。改变轴锥镜之间的距离提供了下述能力,即控制0微米至300微米的环直径,同时保持焦点。轴锥镜系统可用于将锥体以一定角度加工到缝线材料内。在激光加工过程中使用多种直径的锥束以从丝线中移除材料。通过调整锥束直径和锥束相对固位刺/丝线的角度,可加工出利用标准激光束或机械切割方法将不可能获得的多种固位刺构型。例如,在一些实施例中,由轴锥镜对产生的锥束设定为0直径,所述直径在激光的焦点平移到缝线内时逐渐地变大,从而移除3D锥形的缝线材料(以相对于有待形成的固位刺的复合角)。无论环直径如何,利用锥束直径来协调激光功率,以保持环中的恒定能量密度。
图2D示出了从轴锥镜系统入射到平表面278上的a激光束270的代表性影像。如图2E所示,激光束在中心272处具有低功率密度。功率密度在远离中心272移动时增加直至其达到环274中的峰值。功率密度随后在从环274向外移动时迅速下降。可通过改变轴锥镜之间的距离来控制环274的直径D。可使用轴锥镜之间的透镜聚焦该环来控制该环的厚度T。图2E示出了得自轴锥镜系统的激光束(例如图2D的激光束270)的功率密度分布的图示。
图3A示出了用于将缝合线204稳定在激光束202附近(参见图2A)的稳定装置248的实施例的剖面图。稳定装置248降低切割区域附近的缝合线204的移动以便提高激光加工操作的精确性(参见图2A)。如图3A所示,稳定装置248的优选实施例为空气轴承300,所述空气轴承300提供空气流以稳定缝合线304且无需机械性地接触缝合线304。图3A示出了可包括在图2A的稳定装置248内的空气轴承300的剖面图。如图3A所示,空气轴承包括入口喷嘴310和出口喷嘴320。入口喷嘴310和出口喷嘴320具有尖端312、322,所述尖端312、322具有与缝线直径大致相同的内径。在优选的实施例中,针对不同尺寸的缝合线使用不同的喷嘴。入口喷嘴310和出口喷嘴320可通过下述方式来制备:将玻璃管拉延至用于特定缝合线的适当直径并且切割和研磨顶端312、322。
如图3A所示,出口喷嘴320安装在歧管330的腔体332内。O形环340、342将出口喷嘴320密封至腔体332的表面。歧管330被加工成将得自取气管道334的加压气体均匀地递送到腔体332周围。入口喷嘴310与顶端312设置在出口喷嘴320的管腔内,如图所示。入口喷嘴310和出口喷嘴320为同轴设置的。通过入口顶盖350将入口喷嘴310对准并且固定在适当位置。O形环344将入口喷嘴310密封至入口顶盖350。入口顶盖350具有斜面入口352,所述斜面入口352设置为与入口喷嘴310和出口喷嘴320同轴。出口顶盖354安装在歧管330的另一端上。出口顶盖354具有从中伸出出口喷嘴320的出口356。通过多个紧固件358将入口顶盖350、歧管330和出口顶盖354固定在一起。
可通过入口352引入缝合线304。缝合线304穿过入口喷嘴310并且随后通过出口喷嘴320穿出出口喷嘴320的顶端322,如图所示。将加压空气通过引入口334引入并传送到歧管330的腔体332内。加压空气传送到出口喷嘴320内并且从围绕缝合线304的顶端322压出。(一些空气也通过入口喷嘴310漏出)。缝合线304周围的快速流动空气充当空气轴承,以稳定顶端322附近的缝合线304的位置且不接触缝合线304。
图3B示出了仅出口喷嘴320和缝合线304的透视图。如图3B所示,加压空气进入出口喷嘴320的内腔324(箭头360)并且高速地压出出口喷嘴的狭窄顶端322(箭头362)。顶端322内的空气流将缝合线稳定在顶端322的中央内并且因此缝合线不接触出口喷嘴320的壁。此外,高速空气流在其离开顶端322时环绕缝合线304。顶端被设计为在顶端附近的区域中的气流内产生空气层流。在此层流区域中,高速空气流稳定由(如)切割过程引起的缝合线阻尼运动和振动。通过较慢流动的空气将压力施加到高速气流的外面,以将缝合线304强制到气流的中央,如通过箭头364所示。因此,通过出口喷嘴320的顶端322附近的区域370中的空气轴承来稳定缝合线304。空气轴承300被设置为使得稳定区域370位于激光的切割区域中。穿过缝合线304的空气流还起到移除得自激光切割过程的颗粒和烟尘并且还冷却激光切割过程中的缝合线304的作用。缝合线从出口喷嘴320的顶端332穿出以用于在稳定区域中切割固位刺。切割之后,将固位刺移动远离出口喷嘴320。优选的是,固位刺不应移到出口喷嘴内,因为高速空气可损坏固位刺,并且固位刺可在高速空气中引起湍流,从而使得稳定区域370中的缝合线失稳。
对于在不存在空气轴承(参见图3A-3B)的情况下切割USP 2-0蓝色聚丙烯缝线材料而言,据发现下述飞秒激光器参数为有效的:10x物镜0.26N.A.透镜;26mW的平均激光功率;775nm的激光波长;双重频率和具有钛兰宝石连续变频脉冲放大器的模式锁定的铒光纤激光器;122飞秒的脉冲宽度;确立3kHz脉率的RF分频器;和9.5毫米/分钟的切割速度。通过将缝线穿透到丝线的主体内并且随后向外移至边缘来实现最佳切割结果。对于切割USP 4-0蓝色丙烯缝线材料而言,据发现下述飞秒激光器参数为有效的:20x物镜、36mW的平均激光功率;和10毫米/分钟的切割速度。利用这些参数,需要仅1.16秒即可形成一个固位刺。增设空气轴承使固位刺能够更有效地在USP 2-0、4-0和6-0蓝色聚丙烯缝线材料上形成,因为(例如)在切割期间丝线可被稳定并得到冷却。然而,据发现使用UV波长将更有效地切割蓝色聚丙烯缝线材料,因为其更有效地汽化缝线材料且加热周围材料的热量较低。在一个优选的实施例中,使用UV和IR波长的组合来烧蚀材料,其中能量中的约70%或更多以UV波长提供。
图4A为用于操作图2A的激光加工系统200的方法400的流程图。在第一步骤402中,将缝合线安装到传送系统的卡盘上。在安装步骤期间不应将缝合线拉伸至所需张力。每一条缝合线的张力应为相同的。在步骤404中,控制系统操作传送子系统以将缝合线标引和旋转至正确位置以用于形成第一固位刺。将固位刺的分布/位置存储在固位刺分布图案数据或程序文件中。在步骤406中,控制子系统针对缝合线上的标引位置选择正确的固位刺生成图案。固位刺生成图案决定将在特定位置产生的固位刺的最终取向、形状和尺寸。
然后根据选定的固位刺生成图案来操作激光加工系统以在标引位置处形成固位刺。在步骤408中,操作传送系统以将缝合线的目标体积与激光对准。在步骤410中,操作激光子系统以烧蚀/切割目标体积中的材料。步骤410还可包括利用成像子系统来确认烧蚀/切割。在步骤412中,如果需要烧蚀/切割其他材料以形成固位刺,则该过程返回到步骤408,以根据固位刺生成图案操作传送系统,以将新目标体积与激光对准。在步骤412中,如果激光生成图案已完成,则该过程继续前进到步骤414。
在步骤414中,操作成像子系统以对完成的固位刺成像并且将数据影像提供至控制子系统。控制子系统使用影像数据来确认固位刺是否位于由固位刺生成图案定义的公差内。如果固位刺不能得到确认,则控制系统可进行下述操作中的一个或多个:操作传送子系统和激光子系统以校正缺陷;使特定缝合线失效;相对于缝合线标记出异常以用于进一步的检测;为操作人员设定提示;和/或关闭激光加工系统的操作。如果在步骤414中确认固位刺在公差内,则该过程继续前进到步骤416。在步骤416中,如果仍将产生其他固位刺,则该过程返回到步骤404,以用于将缝合线标引到需产生固位刺的下一个位置。在步骤416中,如果已完成全部固位刺,则该过程前进至步骤418。在步骤418中,完成缝合线并且从卡盘卸载缝合线。
图4B-4D还示出了根据图4A的方法形成固位刺的过程中的步骤。如图4B所示,通过传送子系统来纵向地(430)、横向地(432)和轴向地(434)移动缝合线424,以将激光束426与缝合线424的目标体积对准。然后操作激光子系统以从缝合线424烧蚀材料,从而产生腔体或狭槽428。应当注意,腔体428相比激光束426具有较大的直径。在一个实施例中,3μm直径的激光束产生大约7μm直径的腔体。
如图4C所示,将缝合线424逐步纵向430和横向432地移动至一系列位置,以将新目标体积与激光束对准,以产生穿过缝合线424的一系列腔体。目标体积取决于缝线生成图案。应当注意,可优选在切割固位刺的顶端之前进行内部切割,以形成固位刺的组织接合表面。
图4D示出了具有顶端442和固位刺接合表面444的已完成固位刺440。应当注意,顶端442并未抬高到缝合线424的表面之上。在一些情况下可执行后切割处理以将顶端抬高到缝合线424的表面之上。在其他实施例中,固位刺440被设计为有效的,且未将固位刺顶端442抬高到缝合线424的原始表面之上。重复相同的步骤以用于缝合线424上的其余固位刺。应当注意,可利用不同的固位刺生成图案在缝线上的不同位置处产生固位刺的不同构型和取向,且无需不同的切割头或重装载缝合线。
利用激光加工系统来产生固位刺的优势在于下述能力,即在难以和/或不可能利用具有刀片的机械切割制备的构型中形成固位刺。图5A-5D示出了可利用根据本发明的实施例的激光加工系统产生的固位刺构型的实例。图5A-5D示出了本发明的激光加工系统的能力以及可形成的固位刺特征的实例。这些特征可以任何所需的组合进行使用。
图5A示出了固位刺510。应当注意,已从固位刺510的顶端512的前侧移除了额外材料,以形成进入斜坡514。进入斜坡514可让顶端512在施用过程中接合组织而不将顶端512抬高到缝合线502的原始表面之上。本发明的激光加工系统的一个优点是,能够在固位刺成形中移除缝线材料而不仅仅是切割材料。
图5B示出了具有顶端522的固位刺520。应当注意,已从固位刺520的内表面移除了额外材料以产生朝向固位刺520的基部的脊形的第二固位刺524。第二固位刺524用于增强固位刺520的组织接合。本发明的激光加工系统的一个优点在于下述能力:移除材料以使固位刺成形并且还改变切割表面的角度或方向且无需使用刀具的多个机械切割步骤。
图5C示出了构型与图5A的固位刺510类似的固位刺530。然而,在固位刺530的形成过程中,缝合线502既轴向移动也纵向和横向移动。所得固位刺530以一个相对缝合线502的纵向轴线的角度环绕缝合线502。为了形成所要的固位刺所需的任何纵向、横向和轴向运动的组合可用本发明的激光加工系统实现,不存在由机械加工机构施加的限制。
图5D示出了构型与图5A的固位刺510类似的固位刺540。然而,激光加工系统已被用来在固位刺540中开出一个或多个小孔542。在一些实施例中,小孔542可从固位刺540的外表面穿透到固位刺540的组织接合表面(未示出);在固位刺540的形成过程中,缝合线502既轴向移动也纵向和横向移动。小孔542不必(并且优选地不)完全穿过缝合线502。小孔542(或其他移除材料的特征)可用于调节固位刺的柔韧性/强度,促进组织向内生长;和/或增强由固位刺实现的组织接合。
图5E-5H示出了一系列另外的固位刺设计。对于每一种固位刺,使用USP 4-0缝合丝线560。图5E示出了抛物面形固位刺564。切割深度D(在横向上测量)为60μm。切割长度L(在轴向上测量)为250μm。切口565(通过激光移除的材料的沟槽)的宽度为7μm。图5F示出了替代固位刺566,其具有30度的顶端斜面以及随后的基本上平行于缝线的纵向轴线进行切割的固位刺表面。切割深度D(在横向上测量)为0.036mm。切割长度L(在轴向上测量)为0.234mm,但该长度可为仅由固位刺的功能需求限定的任何所需长度。相对缝线轴线的入口角度θ为30度。同样,切口567(通过激光移除的材料的沟槽)的宽度为7μm。
图5G示出了直切形固位刺568。切割深度D(在横向上测量)为60μm。切割长度L(在轴向上测量)为250μm。相对缝线轴线的切割角度θ为13度。切口569(通过激光移除的材料的沟槽)的宽度同样为7μm。图5H示出了前接进入斜坡572的直切形固位刺570。切割深度D(在横向上测量)为60μm。切割长度L(在轴向上测量)为250μm。固位刺570相对缝线轴线的切割角度θ为13度。进入斜坡相对缝线轴线的切割角度θ2为6度。切口571(通过激光移除的材料的沟槽)的宽度同样为7μm,然而因θ和θ2之间的差值而从进入斜坡572移除了额外材料。进入斜坡572用于暴露固位刺570的顶端574,以让固位刺570接合组织而不将缝合丝线560抬高到原始表面之上。
对于较小的缝线直径,上述固位刺构型可按比例缩小尺寸。类似地,对于较小直径的缝线,可通过(例如)调节激光束的功率、脉冲宽度和聚焦来减小切口宽度。例如,对于6-0缝线优选5μm的切口宽度,而对于2-0缝线优选10μm的切口宽度。另外可利用本发明的激光加工系统来实现许多可选择的固位刺设计,包括(例如)2008年4月11日提交的名称为“Self-Retaining Systems For Surgical Procedures”(用于外科手术的自固位系统)的美国专利申请12/101885中所公开的可供选择的固位刺形状,该专利申请以引用方式并入本文。
对于一些激光切割固位刺构型而言,需要和/或有必要将固位刺的顶端抬高到缝合丝线的表面之上,以将固位刺设置成适于接合组织的构型。可通过加热缝合丝线和/或使缝合丝线受到拉力来抬高固位刺,这些方式可采用其一或都采用。一经抬高,就可执行退火步骤以使固位刺保持在抬高的构型。例如,使缝合丝线在156℃下受到10.6克的拉力即为一种可用来将固位刺抬高到缝合丝线之上的方案。
图6A至6C示出了用于在丝线600的表面上制备固位刺的略有不同的方法。图6A示出了丝线600的横截面。如图6A所示,丝线600具有从丝线600凸出的多个脊602。在一个实施例,丝线600以图6A所示的横截面被挤出。然而,可通过多种方式获得丝线600的形状。参见(例如)Goraltchouk等人的名称为“Alternate Geometry Self-retaining Suture”(非传统几何形状的自固位缝线)的美国专利申请12/392939;和Goraltchouk等人的名称为“Composite Self-Retaining Sutures”(复合材料型自固位缝线)的美国专利申请12/340444,这两个专利申请以引用方式并入本文中。
图6B为丝线600的透视图。凸脊602的部分加有阴影。用激光束对准并且移除凸脊602的阴影区域。阴影区域604的移除使得在丝线600的表面上留下多个固位刺606。由于固位刺606是通过移除周围材料604形成的,固位刺形成为从激光切割表面凸出的构型,并且被有利地设置成用于接合组合而无需作任何后处理。可在丝线600的其他凸脊602上类似地形成固位刺以产生倒刺丝线。
图6C为利用参照图6B所述的移除方法形成的倒刺丝线的影像。为了产生图6C所示的倒刺丝线,使用输出功率为0.87瓦的775nm飞秒激光器。丝线的一些最高的特征被移除,留下了从丝线610的表面凸出的所示固位刺616。固位刺616于是通过用激光束从丝线610烧蚀掉周围材料而形成。从图6C可见,固位刺616凸出于丝线610的表面上,并且不需要被抬高或其他后处理以便接合组织。
在图6C所示的实施例中,各个固位刺具有激光切割内表面612和激光切割外表面613。可根据固位刺616的功能所需来选择激光切割内表面612和激光切割外表面613各自的形状。因此可以用多种形状、尺寸和构型来形成固位刺616,包括(例如)Hunter等人的名称为“Self-RetainingSystems For Surgical Procedures”(用于外科手术的自固位系统)的美国专利申请No.12/101,886中所公开的那些固位刺构型,该专利申请的全部内容以引用方式并入本文中。此外,由于各个固位刺是通过激光加工系统单独形成的,因此可以形成这样的自固位缝线:所述固位刺在单个丝线上具有多种不同的形状、尺寸和构型。
图6D示出了缝合丝线的局部剖切视图,所述缝合丝线上有多个通过移除固位刺周围的材料而形成的激光切割固位刺。如图6D所示,丝线620具有初始直径Dmaj。使用激光加工系统从丝线620的表面(参见阴影区域622)移除材料直到其直径减小至Dsub。然而,在用激光移除材料的过程中,激光受到控制以避免移除多个固位刺624形状中的材料。因此,在用激光加工系统移除材料后,缝合丝线626保留直径Dsub并且具有排列在其表面上的多个固位刺624。在一个实施例中,丝线620为6-0聚丙烯缝线。
图6E和6F示出了另一种可选的缝合丝线的剖面图和透视图,所述可选的缝合丝线上具有通过移除固位刺周围的材料而形成的多个激光切割固位刺。图6E示出了坯料缝合丝线630的剖面图。如图6E所示,缝合丝线630具有围绕丝线630的圆周彼此间隔开60度的六个凸脊632。如此前参照图6A-6C所述,利用激光加工系统从凸脊632移除材料,以在丝线630的表面上留下固位刺634,如图6F所示。利用产生自复合角的成形的激光束,可形成形状如图6F所示的固位刺634而不会在移除凸脊632的材料过程中切掉其他固位刺。复合角是指激光束从不垂直于缝线的纵向轴线的角度入射。成形的激光束是指例如用(例如)基于轴锥镜的光学系统形成的锥形激光束。
图7A、7B、和7C示出了可利用激光加工系统产生的一系列固位刺分布和图案。例如,图7A示出了根据本发明的实施例的自固位缝线上的激光切割固位刺的单螺旋分布。图7B示出了根据本发明的实施例的药物洗脱型自固位缝线上的激光切割固位刺的双螺旋分布。图7C示出了根据本发明的实施例的自固位缝线上的激光切割固位刺的高密度分布。激光切割固位刺可具有本文所述的任何激光切割固位刺构型并且/或者不同的激光切割固位刺构型可存在于自固位缝线的不同部位。另外应当注意,本发明的激光加工系统能够沿着单条缝合线产生非均一的固位刺分布以有利于特定的自固位缝线应用。
首先参见图7A,其示出了自固位缝线700上的激光切割固位刺704的单螺旋分布。如图7A所示,自固位缝线700具有尺寸为USP 2-0、4-0、6-0、7-0、8-0、9-0、10-0、11-0、12-0或更小的丝线702。如图7A所示,丝线具有0.25mm的直径,所述丝线为4-0缝线。自固位缝线700包括围绕和沿着丝线702设置成螺旋形图案的多个激光切割固位刺704。如图7A所示,螺旋具有4.46mm的螺距(或5.7捻/英寸)。相同螺旋中的一个激光切割固位刺的基部与相邻激光切割固位刺的基部之间的距离为0.6mm-在轴向上测量的-参见箭头718。在一个实施例中,自固位缝线具有长度为至少70mm倒刺部分712和位于倒刺部分712两侧的100mm的无倒刺引线710、714。倒刺部分712可包括具有一个取向或不同取向的固位刺704。应当注意,由于激光加工系统为非接触式的,则固位刺分布图案可在不存在由如下需要施加的限制的情况下来进行设计,所述需要为在机械切割期间在不损害已切割固位刺的情况下来支承缝线。因此,例如,在一些实施例中,间距可小于固位刺的长度。
现在参见图7B,其示出了自固位缝线720上的激光切割固位刺724的双螺旋分布。如图7B所示,自固位缝线720具有尺寸为USP 2-0、4-0、6-0、7-0、8-0、9-0、10-0、11-0、12-0或更小的丝线722。如图7B所示,丝线具有0.25mm的直径,所述丝线为4-0缝线。自固位缝线720包括多个激光切割固位刺724,它们被布置成围绕并沿着丝线722的双螺旋图案。如图7B所示,各个螺旋具有7mm的螺距(或4.2捻/英寸)。螺旋在轴向上相互偏移0.49mm。同一螺旋中的一个激光切割固位刺的基部与相邻激光切割固位刺的基部之间的距离为1mm(在轴向上测量),见箭头标示738。在一个实施例中,自固位缝线具有长度为至少100mm倒刺部分732和位于倒刺部分732两侧的100mm的无倒刺引线730、734。倒刺部分732可包括具有一个取向或不同取向的固位刺724。应当注意,由于激光加工系统为非接触式的,则固位刺分布图案可在不存在由如下需要施加的限制的情况下来进行设计,所述需要为在机械切割期间在不损害已切割固位刺的情况下来支承缝线。因此,例如,在一些实施例中,间距可小于固位刺的长度。
现在参见图7C,其示出了自固位缝线740上的激光切割固位刺744的高密度分布。如图7C所示,自固位缝线740具有尺寸为USP 7-0、7-0、8-0、9-0、10-0、11-0、12-0或更小的丝线742。如图7C所示,丝线具有0.25mm的直径,所述丝线为4-0缝线。自固位缝线740包括以四个固位刺(各个固位刺隔开90度)成组设置的多个激光切割固位刺744。由四个激光切割固位刺组成的各个组与相邻组错开45度。各固位刺从凹陷部顶端到切口基部的尺寸为0.18mm(在轴向上测量),见箭头标示758。一个组中激光切割固位刺的基部与相邻的激光切割固位刺的基部之间的距离为0.28mm(在轴向上测量),见箭头标示758。在一个实施例中,自固位缝线具有长度为至少70mm倒刺部分752和位于倒刺部分752两侧的100mm的无倒刺引线750、754。倒刺部分752可包括具有一个取向或不同取向的激光切割固位刺744。应当注意,由于激光加工系统为非接触式的,则固位刺分布图案可在不存在由如下需要施加的限制的情况下来进行设计,所述需要为在机械切割期间在不损害已切割固位刺的情况下来支承缝线。因此,例如,在替代实施例中,各个组可包括五个、六个或更多个固位刺,并且/或者间距可小于固位刺的长度,前提条件是固位刺互不干扰。
具有激光切割固位刺的自固位缝线的实例
图8A-8J为一些自固位缝线实例的影像,这些缝合线上制备有多个激光切割固位刺以测试根据图2A的激光加工系统的能力。各例中,缝合线均为蓝色丙烯丝线。
图8A示出了其上具有激光切割固位刺812的2-0聚丙烯缝线810的影像。激光切割固位刺812具有直切构型并且被布置成高密度四螺旋分布。在切割出固位刺812之后,将缝线810在155℃下热处理五分钟以抬高固位刺812。
图8B示出了其上具有激光切割固位刺822的2-0聚丙烯缝线820的影像。激光切割固位刺822具有直切构型并且被布置成双螺旋分布。在切割出固位刺822之后,将缝线820在155℃下热处理五分钟同时承受32克的张力以抬高固位刺822。
图8C示出了其上具有激光切割固位刺832的2-0聚丙烯缝线830的影像。激光切割固位刺832具有直切构型并且被布置成双螺旋分布。在切割出固位刺832之后,缝线830不受拉力地在155℃下热处理五分钟以抬高固位刺832。
图8D示出了其上具有激光切割固位刺842的6-0聚丙烯缝线840的影像。激光切割固位刺842具有进入斜坡构型并且被布置成双螺旋分布。
图8E示出了其上具有激光切割固位刺852的6-0聚丙烯缝线850的影像。激光切割固位刺852具有直切构型并且被布置成双螺旋分布。在切割出固位刺852之后,缝线850承受10.6克的拉力在155℃下热处理五分钟以抬高固位刺852。
图8F示出了其上具有激光切割固位刺802的10-0聚丙烯缝线800的影像。激光切割固位刺852具有直切构型。
图8G示出了其上具有激光切割固位刺862的聚丙烯缝线860的影像。激光切割固位刺862具有直切构型并且被布置成双螺旋分布。在切割出固位刺862之后,缝线860在155℃下热处理五分钟以抬高固位刺862。然后在显微镜下测量缝线860的所得参数L1-L5。缝线直径L1为101.8μm;切割长度L2为99.5μm;切割深度L3为34.5μm;固位刺的顶端在丝线表面上方的高度L4为15.8μm;并且相邻固位刺之间的距离L5为118.3μm。
图8H示出了其上具有激光切割固位刺872的聚丙烯缝线870的影像。激光切割固位刺872具有直切构型并且被布置成双螺旋分布。在切割出固位刺872之后,缝线870在155℃下热处理五分钟以抬高固位刺872。然后在显微镜下测量缝线870的所得参数L1-L4和AN1。缝线直径L3为103.8μm;切割深度L2为29.7μm;固位刺的顶端在丝线表面上方的高度L1为14.6μm;相邻固位刺之间的距离L4为131.3μm;并且角度AN1为14.3度。
图8I示出了其上具有激光切割固位刺882的聚丙烯缝线880的影像。激光切割固位刺882具有直切构型并且被布置成双螺旋分布。在切割出固位刺882之后,缝线880在155℃下热处理五分钟以抬高固位刺882。然后在显微镜下测量缝线880的所得参数L1-L6。缝线直径L6为93.3μm;固位刺基部的宽度L1为77.6μm;切割长度L3为69.2μm;切割深度L4为28.5μm;固位刺的顶端在丝线表面上方的高度L5为14.6μm;并且相邻固位刺之间的距离L2为89.1μm。
图8J示出了其上具有激光切割固位刺892的聚丙烯缝线890的影像。激光切割固位刺892具有直切构型并且被布置成双螺旋分布。在切割出固位刺892之后,缝线890在155℃下热处理五分钟以抬高固位刺892。然后在显微镜下测量缝线890的所得参数L1-L6和AN1。缝线直径L5为96.5μm;固位刺基部的宽度L6为83.4μm;切割长度L1为107.9μm;切割深度L2为37.0μm;固位刺的顶端在丝线表面上方的高度L3为21.2μm;相邻固位刺之间的距离L4为117.2μm;并且角度An1为18度。
以力学方式测试了激光切割的自固位缝线原型的样品的保持强度和拉伸强度,并与机械切割的四螺旋自固位缝线和普通USP 6-0缝线进行比较。结果基于测试10个各缝线的样品。图9A为示出力学测试结果的表。
检查了自固位缝线的激光切割表面的平坦度和均匀度。移除了固位刺以可对丝线的下层激光切割表面成像。固位刺的激光切割组织接合表面(未示出)应具有类似的平坦度和均匀度特征。图9B示出了加工进入缝合线920内的被检查激光切割表面922的影像。图9C示出了从侧面看到的激光切割表面的轮廓的曲线图。
用于提高具有激光切割固位刺的自固位缝线的实用性的标记
如上文所述,标记并识别其中缝线的不同部分具有不同特征的自固位缝线系统的部分是有用的,例如在双向自固位缝线系统中。在自固位缝线系统中,缝线的各个部分之间的功能差异可为存在固位刺、不存在固位刺、和/或固位刺的取向。在一个方面,可能有利的是标记双向缝线的过渡部分。在本发明的一个实施例中,图2A的激光加工系统200也可用来形成激光标记,所述激光标记易于被医生在使用缝线的环境中辨认和区分,由此使外科医生能够找到自固位缝线的过渡区域和/或其他部分。
当形成标记时,激光子系统被控制成可提供改性激光束,所述改性激光束适于使缝合线的着色剂或其他组分变性、漂白、和/或脱色而不会显著地烧蚀、切割、和/或减弱缝合线。当自固位缝线或普通缝线的激光标记应被适当定位来标示自固位缝线的特定部分/特征时,重要的是将激光标记系统配置成可以使激光标记头与缝线的适当位置对准。可便利地使用同一个系统来形成固位刺和激光标记。激光加工系统可产生激光标记,该功能是标引缝线和在其上产生固位刺的同一程序的一部分。
在替代实施例中,在将缝合线装载到图2的激光加工系统200上之前的工序中,在缝合线上形成激光标记或以其他方式形成的标记。在将缝合线装载到激光加工系统200中之后,使用成像子系统230来识别标记的位置并将信息的位置提供给控制子系统250。控制子系统250随后控制传送子系统240来变换缝合线的位置,以使固位刺形成得与所检测标记保持正确关系。例如,缝合线可为一半为一种颜色、一半为另一种颜色的缝线。当装入固位刺形成机器中时,用成像子系统230来寻找两种颜色之间的边界。传送子系统240和激光子系统210以及光学子系统随后被运行在相对于边界的各个位置形成固位刺,使得自固位缝线的过渡部分位于边界处。此替代方法可用于(例如)如下情况,其中标记产生方法不适合集成到激光加工系统200内或者脱开固位刺产生方法来使用更为有效。
为了有利于产生标记,缝合线设有着色剂,所述着色剂一经(例如)激光照射就改变颜色。着色剂包括染料(水溶性)和颜料(非水溶性)。优选的着色剂为非反应性的和生物惰性的。着色剂有多种颜色,包括黑色和白色。另外,着色剂包括可利用替代能量源(例如可使着色剂发荧光或者以其他方式变为可见的“黑光”)看见的染料和颜料。合适的着色剂、标记技术和标记公开于Gross等人的名称为“Bidirectional Self-RetainingSutures With Laser-Marked And/Or Non-Laser Marked Indicia And Methods”(具有激光标记的和/或非激光标记的双向自固位缝线以及方法)的美国临时专利申请61/290750和61/296721中,这两个临时专利申请以引用方式并入本文中。所述缝线着色剂因具有受到无损于缝合线的激光照射就改变颜色的能力而被选用。在优选实施例中,用激光处理缝线使得处理区域产生颜色变化,从而与未处理区域形成高对比度,以便提高激光标记的可见度。在特定实施例中,颜色变化为从有色到无色、从无色到有色、从第一颜色到不同于第一颜色的第二颜色、和/或从第一浓度的颜色到不同浓度的同一颜色。
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。本文所述的缝合线可使用常规用于制备缝线的任何材料,所述材料包括(例如)非降解性聚合物、生物降解性聚合物、和天然材料。就切割而言,可制备或购买聚合物型缝合线/丝线以用于缝线主体,并且随后可在缝线主体上切割固位刺。切割期间,激光束或缝合线中的任一者可相对于另一者移动或者两者均可移动,以控制固位刺的尺寸、形状和深度。
本文所述的激光加工系统的优点在于其为可操作性的,以在多种缝线材料上形成固位刺。合适的缝线材料包括:降解性缝线材料、非降解性缝线材料、天然缝线材料、重组缝线材料和金属缝线材料。降解性缝线材料(也称为“生物降解性缝线”或“吸收性缝线”)为在引入到组织内之后被身体分解和吸收的那些材料。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和单体的断链过程。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。在一些实施例中,例如,利用凝胶渗透色谱法(GPC)来表征聚合物降解,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。非降解性缝线材料(也称为“非吸收性缝线”)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那些材料。
降解性缝线材料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(如,泰科医疗集团(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(如,泰科医疗集团(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(如,泰科医疗集团(Tyco Healthcare Group)的CAPROSYNTM)。溶解性缝线还可包括部分脱乙酰的聚乙烯醇。适用于降解性缝线的聚合物可为直链聚合物、支链聚合物或多轴聚合物。用于缝线中的多轴聚合物的实例在美国专利申请公开No.2002/0161168、No.2004/0024169和No.2004/0116620中有所描述。由降解性缝线材料制成的缝线在该材料降解时会损耗拉伸强度。降解性缝线可呈编织多丝形式或单丝形式。
非降解性缝线材料包括(例如)聚酰胺(也称为尼龙,例如尼龙6和尼龙6,6)、聚酯(如,聚对苯二甲酸乙二醇酯)、聚四氟乙烯(如,膨胀型聚四氟乙烯)、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(如,不锈钢丝)、聚丙烯、聚乙烯、丝线和棉线。由非降解性缝线材料制成的缝线适用于下述应用,其中缝线旨在永久性地保留在体内或者旨在将其在已完成其预期目的之后从身体物理地移除。
临床应用
除了普通伤口闭合和软组织修复应用之外,自固位缝线还可用于多种其他适应症。
本文所述的自固位缝线可用于各种牙科手术(即,口腔和上颌面外科手术)中并且因而可称为“自固位牙科缝线”。上述手术包括(但不限于)口腔外科手术(如,埋伏牙或坏牙)、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、成形外科手术、唇裂或腭裂的修复、先天性颅面畸形、以及美容外科手术。自固位牙科缝线可为降解性的或非降解性的,并且尺寸通常可在USP 2-0至USP 6-0的范围内。
本文所述的自固位缝线也可用于组织复位外科手术中并且因而可称为“自固位组织复位缝线”。这种外科手术包括(但不限于)面部除皱手术、颈部除皱手术、前额拉皮手术、大腿拉皮手术和乳房拉皮手术。用于组织复位手术中的自固位缝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刺的缝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、以及各种类型的整形显微外科手术。当其他选择(例如,原发性闭合、二期愈合、皮肤移植、就近瓣转移和远距离瓣转移)不能胜任时,将显微外科整形术用于复杂的整形外科手术问题。自固位显微缝线具有非常小的口径,通常小至USP 9-0、USP 10-0、USP 11-0或USP 12-0,并且可具有相应尺寸的附接缝合针。显微缝线可为降解性的或非降解性的。
本文所述的自固位缝线可用于类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。眼科自固位缝可为降解性的或非降解性的,并且具有相应小口径的附接缝合针。另外,自固位缝线可用于各种兽医应用,适合于动物保健中的许多外科和外伤用途。
在一些实施例中并且如本文更完整所述,本发明包括在下述标号段落中标示的自固位缝线系统和激光切割固位刺:
一种自固位缝合线,其中:所述缝合线具有表面和中央轴线;分布在所述表面上的多个组织固位刺;其中所述多个组织固位刺各自具有相对所述缝合线的中央轴线取向成锐角的至少一个组织接合表面;并且其中所述至少一个组织接合表面为激光切割表面。
一种自固位缝合线,其中:
所述缝合线具有表面和中央轴线;
分布在所述表面上的多个组织固位刺;
其中所述多个组织固位刺各自具有顶端和相对所述缝合线的中央轴线取向成锐角的至少一个组织接合表面;
其中所述至少一个组织接合表面为激光切割表面;并且
其中所述多个组织固位刺各自具有进入斜坡,从所述进入斜坡处已从邻近所述固位刺的顶端的所述缝合线移除一定体积的材料,所述进入斜坡适合于促进所述固位刺的组织接合表面与组织接合。
根据段落148和149所述的自固位缝合线,其中:所述缝合线包括限定所述组织固位刺的多个激光切割狭槽;各个狭槽具有宽度,其中材料已被移除;并且其中所述多个组织固位刺中的每一个的至少一个组织接合表面由激光切割狭槽限定。
根据段落148和149所述的自固位缝合线,其中所述缝合线具有不大于USP 2-0的尺寸。
根据段落148和149所述的自固位缝合线,其中所述缝合线具有不大于USP 4-0的尺寸。
根据段落148和149所述的自固位缝合线,其中所述缝合线具有不大于USP 6-0的尺寸。
根据段落148和149所述的自固位缝合线,其中所述缝合线具有不大于USP 8-0的尺寸。
根据段落148和149所述的自固位缝合线,其中所述缝合线具有不大于USP 10-0的尺寸。
一种自固位缝线,包括:
缝合线,所述缝合线具有其中已移除一定体积的缝合线材料的多个狭槽,
其中各个狭槽相对所述缝合线的纵向轴线取向成锐角并且具有外侧面和内侧面;并且
其中各个狭槽的所述外侧面限定组织固位刺的组织接合表面。
根据段落156所述的自固位缝线,其中所述多个狭槽为激光切割的。
根据段落156所述的自固位缝线,其中各个狭槽的所述内侧面大致平行于各个狭槽的所述外侧面。
根据段落156所述的自固位缝线,其中各个狭槽的所述内侧面与各个狭槽的所述外侧面沿着所述狭槽间隔开大致相同的距离。
根据段落156所述的自固位缝线,其中各个狭槽的所述内侧面与各个狭槽的所述外侧面沿着所述狭槽间隔开10μm或更小的大致相同的距离。
根据段落156所述的自固位缝线,其中各个狭槽的所述内侧面与各个狭槽的所述外侧面沿着所述狭槽间隔开7μm或更小的大致相同的距离。
根据段落156所述的自固位缝线,其中各个狭槽的所述内侧面与各个狭槽的所述外侧面沿着所述狭槽间隔开5μm或更小的大致相同的距离。
根据段落156所述的自固位缝线,其中各个狭槽的所述内侧面与各个狭槽的所述外侧面沿着所述狭槽间隔开3μm或更小的大致相同的距离。
根据段落156所述的自固位缝线,其中所述缝合线具有不大于USP 4-0的尺寸。
根据段落156所述的自固位缝线,其中所述缝合线具有不大于USP 6-0的尺寸。
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。可在本质上不脱离本发明的新颖教导内容和优点的前提下,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精神和范围内的所有此类修改形式、省略形式、添加形式和等同形式。
Claims (17)
1.一种自固位缝合线,其中:
所述缝合线具有表面和中央轴线;
分布在所述表面上的多个组织固位刺;
其中所述多个组织固位刺各自具有顶端和相对所述缝合线的中央轴线取向成锐角的至少一个组织接合表面;
其中所述至少一个组织接合表面为激光切割表面;并且
其中所述多个组织固位刺各自具有进入斜坡,从所述进入斜坡处已从邻近所述固位刺的顶端的所述缝合线移除一定体积的材料,所述进入斜坡适合于促进所述固位刺的组织接合表面与组织接合。
2.根据权利要求1所述的自固位缝合线,其中:
所述缝合线包括限定所述组织固位刺的多个激光切割狭槽;
各个狭槽具有宽度,其中材料已被移除;并且
其中所述多个组织固位刺中的每一个的所述至少一个组织接合表面由激光切割狭槽限定。
3.根据权利要求1所述的自固位缝合线,其中所述缝合线具有不大于USP 2-0的尺寸。
4.根据权利要求1所述的自固位缝合线,其中所述缝合线具有不大于USP 4-0的尺寸。
5.根据权利要求1所述的自固位缝合线,其中所述缝合线具有不大于USP 6-0的尺寸。
6.根据权利要求1所述的自固位缝合线,其中所述缝合线具有不大于USP 8-0的尺寸。
7.根据权利要求1所述的自固位缝合线,其中所述缝合线具有不大于USP 10-0的尺寸。
8.一种自固位缝线,包括:
缝合线,所述缝合线具有其中已移除一定体积的缝合线材料的多个狭槽,
其中各个狭槽相对所述缝合线的纵向轴线取向成锐角并且具有外侧面和内侧面;并且
其中各个狭槽的所述外侧面限定组织固位刺的组织接合表面。
9.根据权利要求8所述的自固位缝线,其中所述多个狭槽为激光切割的。
10.根据权利要求8所述的自固位缝线,其中各个狭槽的所述内侧面大致平行于各个狭槽的所述外侧面。
11.根据权利要求8所述的自固位缝线,其中各个狭槽的所述内侧面与各个狭槽的所述外侧面沿着所述狭槽间隔开大致相同的距离。
12.根据权利要求8所述的自固位缝线,其中各个狭槽的所述内侧面与各个狭槽的所述外侧面沿着所述狭槽间隔开10μm或更小的大致相同的距离。
13.根据权利要求8所述的自固位缝线,其中各个狭槽的所述内侧面与各个狭槽的所述外侧面沿着所述狭槽间隔开7μm或更小的大致相同的距离。
14.根据权利要求8所述的自固位缝线,其中各个狭槽的所述内侧面与各个狭槽的所述外侧面沿着所述狭槽间隔开5μm或更小的大致相同的距离。
15.根据权利要求8所述的自固位缝线,其中各个狭槽的所述内侧面与各个狭槽的所述外侧面沿着所述狭槽间隔开3μm或更小的大致相同的距离。
16.根据权利要求8所述的自固位缝线,其中所述缝合线具有不大于USP 4-0的尺寸。
17.根据权利要求8所述的自固位缝线,其中所述缝合线具有不大于USP 6-0的尺寸。
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CN105916451B (zh) * | 2014-01-27 | 2021-09-07 | 伊西康公司 | 具有不对称固位部的自固位缝合线装置及其制造方法 |
CN113197705A (zh) * | 2021-04-02 | 2021-08-03 | 苏州大学 | 一种倒刺蚕丝缝合线及其制备方法 |
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