CN101902974B - 具有由热接触介导的保持器的自留缝线 - Google Patents

具有由热接触介导的保持器的自留缝线 Download PDF

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CN101902974B
CN101902974B CN2008801220497A CN200880122049A CN101902974B CN 101902974 B CN101902974 B CN 101902974B CN 2008801220497 A CN2008801220497 A CN 2008801220497A CN 200880122049 A CN200880122049 A CN 200880122049A CN 101902974 B CN101902974 B CN 101902974B
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阿列克谢·格拉尔绰克
勒夫·德拉贝特斯基
杰拉德·F·库明斯
罗伯特·A·赫尔曼
亚历山大·耐玛恭
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Angiotech Pharmaceuticals Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166Sutures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166Sutures
    • A61B2017/06176Sutures with protrusions, e.g. barbs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166Sutures
    • A61B2017/0619Sutures thermoplastic, e.g. for bonding, welding, fusing or cutting the suture by melting it

Abstract

本发明提供用在施用于组织的手术中的缝线以及用于形成此缝线的方法。缝线能包括细长缝线本体和多个从并沿该细长缝线本体延伸的由热接触介导的保持器。由热接触介导的保持器能通过使细长缝线本体与一个或多个受热元件短暂接触而形成。

Description

具有由热接触介导的保持器的自留缝线
技术领域
本发明总地涉及用于外科手术的自留缝线、制造用于外科手术的自留缝线的方法及其用途。
背景技术
缝线通常用于将人类或动物组织,诸如皮肤、肌肉、腱、内脏、神经和血管中的伤口闭合或包扎在一起。缝线能由不可吸收的材料,诸如丝织品、尼龙、聚丙烯或棉线形成,或者可替代地,缝线能由生物可吸收材料,诸如但不限于乙交酯、聚对二氧杂环己酮和ε-己内酯均聚物和/或共聚物形成。
缝线通常由具有锋利尖端的针的丝状缝合线组成(缝线和手术针的附接在US专利No.3,981,307、5,084,063、5,102,418、5,123,911、5,500,991、5,722,991、6,012,216和6,163,948中以及US专利申请公布No.2004/0088003中描述)。
自留缝线(经常称为“带倒刺的缝线”)与传统缝线的区别在于:它们拥有许多微小保持器(经常是倒刺),这些保持器在布置之后锚固到周围组织中,从而消除了对用以将相邻组织附在一起的打结的需求,并且已在例如US专利No.6,848,152和欧洲专利1 075 843中进行了描述。这些保持器从缝线外围突出并且布置为当在一个方向(相对于保持器的突出方向)上拉过组织时允许自留缝线的通过,而当在相反的方向上拉时抵抗自留缝线的运动。保持器可至少在沿缝线的方向上减小缝线的滑移并且能可选地避免缝线的打结。
自留缝线可以是单向的,具有一个或多个沿缝合线的长度在一个方向上定向的保持器;或双向的,通常具有一个或多个沿缝合线的一部分在一个方向上定向的保持器,继之以一个或多个在缝合线的剩余部分上在另一(经常是相反的)方向上定向的保持器(如在US专利No.5,931,855和6,241,747中的带倒刺的保持器的上下文中描述的)。尽管任意数量的顺序构造或间歇构造的保持器是可能的,但是最通常的形式包括位于一端处的针,然后是“远离”该针突出并直至到达缝线的过渡点(经常是中点)的倒刺;在该过渡点处,在缝合线附接到位于相对端处的第二针之前,倒刺的构造沿缝合线的剩余长度自身反转180°(即,倒刺现在面向相反的方向)。此处提及的所有专利和专利申请的公开通过参引合并。
单向自留缝线可以包括末端和相对端,该末端是尖的以当通过末端拉缝线时,该末端能够穿透并通过该组织,而该相对端包括锚定器,该锚定器用于在最初插入点处与组织接合以限制缝线的移动。可替代地,双向自留缝线可以包括分组的并且沿缝线的一个部分在一个方向上延伸的保持器以及分组的并且沿缝线的另一部分在相反方向上延伸的相对保持器。当植入使得两组保持器与组织接合时,保持器能抵抗缝线通过组织在任一方向上的移动。
外科医生可使用具有附接缝线的手术针(该缝线能是平滑的单丝或者能是多丝)来在伤口的相对面上交替刺入组织以将伤口缝合。用于将自留缝线放在组织中以将伤口闭合或包扎在一起的技术可以包括以诸如Z字形的直线式样以及诸如阿尔法、正弦和螺旋形的曲线式样穿起自留缝线。此外,在诸如脸部、颈部、腹部或胸部区域等整容手术的过程中,外科医生可使用自留缝线以定位和支撑没有伤口的组织。
更具体地,自留缝线能在人类和动物中的表面和深部外科手术中使用,用于闭合伤口、修复创伤或缺损、将组织连接在一起[使离断组织接近、封闭解剖空间、将单个或多个组织层附在一起、在两个中空(内腔)结构之间建立吻合术接合、使组织毗连、将组织附接或重附接到其合适的解剖位置]、将外来元件附接到组织(固定医学植入物、装置、假体和其它功能或支撑装置)以及用于将组织重定位到新的解剖位置(修复、组织提升、组织移植及相关过程),这些仅仅是一些示例。
缝线通常由附接到具有锋利尖端的针的丝状缝合线组成(缝线和手术针的附接在US专利No.3,981,307、5,084,063、5,102,418、5,123,911、5,500,991、5,722,991、6,012,216和6,163,948中以及US专利申请公布No.2004/0088003中描述)。通常,针前进穿过位于伤口的一侧的预期组织,然后穿过伤口的相邻侧以形成“环”,然后通过在缝线中对该环打结而完成。
缝线材料概括地分类为:生物可吸收的(即,它们在身体中随时间分解),诸如那些由肠线、乙交酯聚合物和共聚物、丙交酯聚合物和共聚物、聚醚酯构成的材料;或不可吸收的(永久性的;不可降解的),诸如那些由聚酰胺、聚四氟乙烯、聚对苯二甲酸乙二醇酯、聚氨酯、金属合金、金属(例如,不锈钢线)、聚丙烯、聚乙烯、丝织品和棉线制成的材料。已发现可吸收缝线在其中缝线移除可能会危及修补或者其中自然愈合过程致使由缝线材料提供的支撑在伤口愈合完成之后不必要的情形中;例如在完成没有并发症的皮肤闭合中是特别有用的。不可降解(不可吸收)缝线在可能期望延长愈合或者需要缝线材料对伤口提供长时期的物理支撑的伤口中;例如在深部组织修复、高张力伤口、许多整形外科修复和一些类型的外科吻合术中使用。
自留缝线设计用于当在与缝线最初在组织中布置的方向不同的方向上拉缝线时与组织接合。具有倒刺的无结组织接近装置先前已在例如US专利No.5,3742,68中描述,该专利公开了具有倒刺状突出部的有装备的锚定器,而具有带倒刺的侧向构件的缝线组件已在US专利No.5,584,859和6,264,675中描述。描述带倒刺的缝线的早期专利中的一个是US专利No.3,716,058,该专利公开了一种缝线,该缝线在其相对端处具有一个或多个相对坚硬的倒刺;倒刺仅在缝线的末端处存在将限制倒刺的有效性。具有多个倒刺的缝线在US专利No.5,931,855和US专利No.6,241,747中描述,所述多个倒刺沿缝线的较大部分定位,该US专利No.5,931,855公开了一种单向带倒刺的缝线,而该US专利No.6,241,747公开了一种双向带倒刺的缝线。用于通过使倒刺切入缝线本体中而在缝线上形成倒刺的方法和设备已例如在US专利No.6,848,152和7,225,512中描述。此外制造具有截头圆锥形保持器的缝线的方法已例如在欧洲专利1 075 843和US专利公布No.2007/0038429中描述。
尽管现有自留缝线的优点,但是仍存在对新的和优选改进的自留缝线及其制造方法的需求和期望。
发明内容
此处提供缝线和用于形成刺缝线的方法,所述缝线用在施用于组织的手术中。缝线能包括细长缝线本体和多个从并沿该缝线本体延伸的由热接触介导的保持器。由热接触介导的保持器能通过使细长缝线本体与一个或多个受热元件短暂接触而形成。
一个或多个实施例的细节在下文的描述中阐述。根据描述、附图和权利要求,其它特征、目的和优点将是明显的。此外,此处引用的所有专利和专利申请的公开通过参引完全合并于此。
附图说明
图1是传统自留缝线的一部分的透视图,该自留缝线具有切入缝线本体中的保持器。
图2A是根据本发明一实施例的自留缝线的一部分的透视图,该自留缝线包括多个从缝线本体延伸的由热接触介导的保持器。
图2B是图2A的自留缝线的部分的侧视图。
图2C是受热元件的一部分的透视图,该受热元件包括位于外腔内的内腔。
图3A-图3D显示了根据本发明一实施例,如何能通过使受热元件与细长缝线本体的外围短暂接触而制造保持器。
图4是导热块的侧视图,该导热块包括多个自其延伸的导热元件,所述导热元件能用于制造根据本发明实施例的自留缝线。
图5A和图5B示出了受热元件和缝线本体如何能相对于彼此在不同的方向上移动以形成根据本发明实施例的自留缝线。
图6是根据本发明实施例的自留缝线的一部分的侧视图,该自留缝线包括变尺寸的由热接触介导的保持器。
图7是用于概述形成根据本发明实施例的自留缝线的方法的高级流程图。
具体实施方式
在阐述本发明之前,首先对下文使用的特定术语的定义进行阐述可能对于本发明的理解是有帮助的。
“自留系统”指与用于将缝线布置到组织中的装置一起的自留缝线。此布置装置非限制地包括缝线针和其它布置装置以及位于缝线本身上的用以穿透组织的足够坚硬和锋利的末端。
“自留缝线”指一种缝线,该缝线不需要位于其末端的结或缝线锚定器以便保持其在外科手术期间所布置的位置。这些缝线可以是单丝缝线或编织缝线,且在布置和固定两个阶段中定位在组织中,并且包括至少一个组织保持器。
“组织保持器”(或简单地“保持器”或“倒刺”)指一种具有保持器本体和保持器末端的缝线元件,该保持器本体从缝线本体突出,而该保持器末端适于穿透组织。每个保持器适于通过基本上面向该布置方向定向而抵抗缝线在与外科医生将缝线布置到组织中所沿的方向不同的方向上的运动。由于在布置期间移动通过组织的每个保持器的组织穿透末端背对布置方向(缝线在布置期间的通过方向),所以在此阶段期间,组织保持器应不卡住或抓住组织。一旦自留缝线已布置,在另一经常与该布置方向相反的方向上施加的用以将缝线固定在适当位置的力导致保持器基本上沿缝线本体从其布置位置移置并导致保持器末端刺入组织中,从而导致组织卡在保持器与缝线本体之间。
“保持器构造”指组织保持器的构造并且能包括诸如尺寸、形状、表面特性等特征。这些有时也称为“倒刺构造”。
“双向缝线”指一种自留缝线,该自留缝线在一端具有在一个方向上定向的保持器,而在另一端具有在另一方向上定向的保持器。双向缝线通常在缝合线的每端处配有针。许多双向缝线具有位于两个倒刺定向之间的过渡部分。
“过渡部分”指双向缝线的位于在一个方向上定向的第一组保持器(倒刺)与在另一方向上定向的第二组保持器(倒刺)之间的无保持器(无倒刺)的部分。
“缝合线”指缝线的丝状本体部分,并且对于需要针布置的缝线,缝合线不包括缝线针。缝合线可以是单丝或多丝的。
“单丝缝线”指包括单丝缝合线的缝线。
“编织缝线”指包括多丝缝合线的缝线。此缝合线中的丝线通常编织、缠绕或编结在一起。
“可降解(也称为“生物可降解”或“生物可吸收”)缝合线”指在引入组织之后分解并被身体吸收的缝合线。通常,降解过程至少部分地通过生物学系统调解或在生物学系统中执行。“降解”指断链过程,聚合物链通过该降解过程裂解成低聚物和单体。断链可通过各种机制发生,例如包括通过化学反应(例如,水解、氧化/还原、酶促机制或这些的组合)或者通过热过程或光解过程。聚合物降解可例如使用监控腐蚀和分解期间的聚合物分子质量变化的凝胶渗透色谱法(GPC)来表征。可降解缝线材料可包括聚合物,诸如聚乙醇酸、乙交酯和丙交酯的共聚物;聚三亚甲基碳酸酯和乙交酯与二甘醇的共聚物(例如,MAXONTM、Tyco Healthcare Group);由乙交酯、聚三亚甲基碳酸酯和二氧环己酮组成的三元共聚物(例如,BIOSYNTM[乙交酯(60%)、聚三亚甲基碳酸酯(26%)和二氧环己酮(14%)],Tyco Healthcare Group);乙交酯、己内酯、聚三亚甲基碳酸酯和丙交酯的共聚物(例如,CAPROSYNTM,Tyco Healthcare Group)。这些缝线可以是编织的多丝形式或者是单丝形式。本发明中使用的聚合物能是线性聚合物、支化聚合物或多轴聚合物。缝线中使用的多轴聚合物的示例在US专利申请公布No.20020161168、20040024169和20040116620中描述。此外可降解缝线能包括可溶解缝线,所述可溶解缝线由可溶解聚合物,诸如部分脱乙酰化的聚乙烯醇聚合物制成,但不限于此。随着材料降解,由可降解缝线材料制成的缝线失去抗拉强度。
“不可降解(也称为“不可吸收”)缝线”指一种缝线,该缝线包括通过断链,诸如化学反应过程(例如,水解、氧化/还原、酶促机制或这些的组合)或者通过热过程或光解过程不降解的材料。不可降解的缝线材料包括聚酰胺(也称为尼龙,诸如尼龙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,膨体聚四氟乙烯)、聚醚酯,诸如聚丁酯(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,不锈钢线)、聚丙烯、聚乙烯、丝织品和棉线。由不可降解缝线材料制成的缝线适于这样的应用,即在所述应用中,缝线意欲永久保持或者意欲从身体中物理移除。
“缝线直径”指缝线本体的直径。将要理解的是各种缝线长度可与此处所述的缝线一起使用并且尽管术语“直径”经常与圆形周界相关联,但应当理解的是此处表示与任意形状的周界相关联的横截面尺寸。缝线定尺寸基于直径。缝线尺寸的美国药典(“USP”)标号在较大的范围中从0延续到7,而在较小的范围中从1-0延续到11-0;在该较小范围中,带连字符的零前面的值越高,缝线直径越小。缝线的实际直径将取决于缝线材料,从而作为示例,尺寸5-0且由胶原制成的缝线将具有0.15mm的直径,而具有相同的USP尺寸标号但由合成的可吸收材料或不可吸收材料制成的缝线将各具有0.1mm的直径。用于特定目的的缝线尺寸的选择取决于因素诸如要缝合的组织的特征以及整容关切的重要性;同时较小的缝线可更容易通过紧密的手术部位操作并且与较少的疤痕相关联,由指定材料制造的缝线的抗拉强度趋于随着尺寸的减小而降低。要理解的是此处公开的缝线和制造缝线的方法适合于各种直径,非限制地包括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。
“缝线布置端”指缝线的要布置到组织中的端部;缝线的一端或两端可以是缝线布置端。缝线布置端可附接到诸如缝线针的布置装置,或者可足够锋利和坚硬以靠其自身穿透组织。
“有装备的缝线”指在至少一个缝线布置端上具有缝线针的缝线。
“针附接”指针与需要针来布置到组织中的缝线的附接,并且能包括诸如卷边、型锻、使用粘合剂等方法。缝线与针的附接点称为型锻点。
“缝线针”指用于将缝线布置到组织中的针,其以许多不同的形状、形式和成分出现。具有两种主要类型的针,致外伤针和不致外伤针。致外伤针具有通道或钻孔端(即,孔或眼)并且与缝合线分开提供并且现场穿线。不致外伤针是无眼的并且在工厂通过型锻被附接到缝线,由此缝线材料在针的钝端处插入通道中,然后变形成最终形状以将缝线和针固定在一起。这样,不致外伤针不要求用于穿线的现场额外时间并且在针附接点处的缝线末端小于针本体。在致外伤针中,丝线从两侧的针孔中出来并且当缝线穿过时,它经常在一定程度上割裂组织。大部分新式缝线是型锻不致外伤针。不致外伤针可永久地型锻到缝线或者可设计为利用急剧的径直牵拉而离开缝线。这些“脱离”通常用于每根缝线仅穿过一次然后打结的间断缝线。对于不间断的带倒刺的缝线,这些不致外伤针将是理想的。
此外缝线针可根据其尖端几何形状进行分类。例如针可以是(i)“锥形的”,由此针本体是圆的并逐渐平滑变细成为尖端;(ii)“三角的(cutting)”,由此针本体是三角形的并在内部具有削尖的刃口;(iii)“反三角的(reverse cutting)”,由此刃口在外部;(iv)“套管针”或“圆体角”,由此针本体是圆的并且逐渐变细,但终止于小三角形的切削尖端中;(v)“钝”尖,用于缝合脆弱的组织;(vi)“横割口”或“铲形针”,由此针在顶部和底部是平直的,沿前面到一侧具有刃口(这些通常用于眼部手术)。
此外缝线针可具有若干形状,包括(i)直的,(ii)半弯形或雪撬形的,(iii)1/4圆,(iv)3/8圆,(v)1/2圆,(vi)5/8圆,(vii)和复合曲线。
例如,缝线针在US专利No.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 Surgica Corp.,Norwalk,CT);以及5,312,422(Linvatec Corp.,Largo,FL);以及7,063,716(Tyco Healthcare,North Haven,CT)中描述。其它缝线针例如在US专利No.6,129,741;5,897,572;5,676,675和5,693,072中描述。此处所述的缝线可利用各种针型(非限制地包括弯曲的、直的、长的、短的、微型的等)、针切削面(非限制地包括三角的、锥形的等)以及针附接技术(非限制地包括钻孔端、卷曲等)进行布置。此外,此处所述的缝线本身可包括足够坚硬和锋利的末端以便完全地省去对布置针的需求。
“针直径”指缝线布置针在该针的最宽点处的直径。尽管术语“直径”经常与圆形周界相关联,但应当理解的是此处表示与任意形状的周界相关联的横截面尺寸。
“伤口闭合”指一种用于闭合伤口的外科手术。损伤,尤其是皮肤或另外的外部或内部表面被切割、划破、刺穿或以其它方式破裂的受伤称为伤口。伤口通常在任意组织的完整性受损(例如,皮肤破裂或烧伤、肌肉撕裂或骨折)时出现。伤口可能由诸如枪击、跌倒或外科手术的行为;由感染疾病;或由潜在的医学状态导致。通过连接划破、切割或以其它方式使组织分离的伤口的边缘或使所述边缘紧密接近,手术伤口封口促进康复的生物学结果。手术伤口封口直接置于或接近组织层,这用于将需要桥接在伤口的两个边缘之间的间隙的新组织形成物的体积减到最小。封口能用于功能性目的和美学目的。这些目的包括通过使皮下组织接近来消除无效腔、通过细致的表皮对准将疤痕形成减到最小并且通过皮肤边缘的精确外翻来避免凹陷瘢痕。
“组织提升手术”指一种用于将组织从较低的高度重定位到较高的高度(即,在与重力的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撑在正常的解剖学位置中。然而,随着年龄的增长,重力作用实现此组织和下面韧带的向下牵引,并且脂肪降到表面筋膜与深部面部筋膜之间的平面中,因而面部组织能够下陷。面部提升手术设计为提升这些下陷组织,并且是称为组织提升手术的医学程序的更通常类别的一个示例。更通常地,组织提升手术反转随时间由重力作用以及导致组织下陷的其它瞬时效应,诸如基因效应导致的外貌变化。应当注意的是组织也能在无提升的情况下重定位;在一些手术中,对组织进行侧向(远离中线)、中间(朝着中线)或向下(降低)重定位,以便恢复对称(即,重定位使得身体的左侧和右侧“匹配”)。
“医学装置”或“植入物”指任何放在身体中的用于恢复生理机能、减小/消除与疾病关联的症状和/或修复/替换受损或患病的器官和组织的物体。尽管通常由外源性的生物可相容合成材料(例如,医用不锈钢、钛和其它金属;聚合物,诸如聚氨酯、硅、PLA、PLGA以及其它材料)构成,但是一些医学装置和植入物包括源自动物(例如,“异种移植物”,诸如整个动物器官;动物组织,诸如心瓣;天然存在的或化学改性的分子,诸如胶原、透明质酸、蛋白质、碳水化合物等),人类供体(例如,“同种异体移植物”,诸如整个器官;组织,诸如骨移植物、皮肤移植物等),或来自患者自身(例如,“自体移植物”,诸如隐静脉移植物、皮肤移植物、腱/韧带/肌肉移植物)的材料。能在与本发明结合的手术中使用的医学装置包括但不限于整形外科植入物(人造关节、韧带和腱;螺钉、板和其它可植入硬件)、牙齿植入物、血管内植入物(动脉和静脉脉管旁路移植物、血液透析通路植入物;自体同源的和合成的)、皮肤植入物(自体同源的,合成的)、管子、引流管、可植入组织填充剂、泵、分流管、密封剂、外科料片(例如,疝补片、组织支架)、瘘管治疗装置、脊柱植入物(例如,人造椎间盘、脊柱融合装置等)等。
A.自留缝线
自留缝线(经常称为“带倒刺的缝线”)与传统缝线的区别在于:它们拥有许多微小的组织保持器(诸如倒刺),这些保持器在布置之后锚固到组织中并且抵抗缝线在与保持器所面向的方向相反的方向上的运动,从而消除了对用以将相邻组织附在一起的打结的需求(“无结”封口)。通过消除打结,避免了关联的并发症,包括但不限于(i)分散(缝线,通常结在皮下闭合之后穿过皮肤的状态),(ii)感染(细菌经常能附接在由结形成的空间中并在所述空间中滋生),(iii)块/团(保留在伤口中的大量缝线材料是包括该结的部分),(iv)滑移(结能滑动或松开),以及(v)刺激(结用作伤口中的一块“异物”)。与所打的结关联的缝线环可能导致局部贫血(它们形成张力点,所述张力点能压缩组织并限制血液向该区域的流动)以及增加的手术伤口处开裂或破裂的缝线。此外打结是劳动密集型的并且能包括闭合手术伤口所花费的大量时间。附加的手术程序时间不仅对于患者有害(并发症发生率随麻醉状态下花费的时间而上升),而且增加了手术的总体费用(许多外科手术估计每分钟的手术时间花费在15美元与30美元之间)。因而,无结缝线不仅使患者能够经历改善的临床结果,而且节省与延长的手术和后续治疗关联的时间和费用。
此外用于伤口闭合的自留系统导致伤口边缘的更好接近,使张力沿伤口的长度均匀地分布(减小能破裂或导致局部贫血的张力区),(通过消除结)减小保留在伤口中的缝线材料的体积以及减少分散物(缝线材料-通常是结-通过皮肤表面的挤出)。认为所有这些特征减小了疤痕、改善了美容术以及相对于利用普通缝线或短纤维实施的伤口闭合提高了伤口强度。
自留缝线在即使没有施加于缝线的张力的情况下将组织锚固和固定在适当位置的能力是比普通缝线提供优越性的特征。当封闭处于张力之下的伤口时,此优点在若干方面显示:(i)多个保持器能沿缝线的整个长度消散张力(与将张力集中在离散点处的打结间断缝线相反,提供数百个“锚固”点;这产生出众的美容结果并减小了缝线将“滑动”或穿过的机会);(ii)复杂的伤口几何形状能以均一的方式以比利用间断缝线所能实现的更高的精度和精确性闭合(圆、弧、锯齿边缘);(iii)它们消除了对“第三只手”的需求,在传统缝合和打结期间,经常需要该第三只手来保持沿伤口的张力(以防止当在打结期间,张力短暂释放时的“滑移”);(iv)它们在打结在技术上困难的手术中,诸如在深伤口或腹腔镜检查手术中是出众的;以及(v)它们能用于在确定闭合之前接近和固定伤口。由此,自留缝线在解剖学上的紧密或深位置(诸如骨盆、腹部和胸腔)中提供更容易的处理并且在腹腔镜检查和微创手术中能够容易地接近组织;所有这些均不必经由结来固定封口。较高的精度使自留缝线能用于比利用普通缝线所能实现的更复杂的闭合(诸如直径不匹配、较大缺损或荷包缝合法的闭合)。
此外自留缝线适合于各种专科症状,例如它们适于组织提升手术,在组织提升手术中,组织从其先前位置移动并重定位到新的解剖位置(这通常在提升“下垂”组织并将其固定在更“年轻”位置;或将“不在适当位置”的组织移回到其正确解剖位置的整容手术中执行)。这些手术包括面部提升、额头提升、胸部提升和臀部提升等。
自留缝线可以是单向的,具有一个或多个沿缝合线的长度在一个方向上定向的保持器;或双向的,通常具有一个或多个沿丝线的一部分在一个方向上定向的保持器,继之以一个或多个在丝线的剩余部分上在另一(经常相反)方向上定向的保持器(如在US专利No.5,931,855和6,241,747中的带刺保持器中描述的)。
尽管任意数量的顺序或间歇构造的保持器是可能的,但是通常的形式包括位于一端处的针,然后是“远离”该针突出直至到达缝线的过渡点(经常中点)的倒刺;在该过渡点处,在缝合线附接到位于相对端处的第二针之前,倒刺的构造沿缝合线的剩余长度自身反转大约180°(使得倒刺现在面向相反的方向)(由此位于缝线的此部分上的倒刺也背向最近的针)。换句话说,双向自留缝线的两个“半体”上的倒刺指向中间,而过渡部分(无保持器)散置于它们之间,针附接到任一端。
如上所述,尽管自留缝线具有很多优点,但在此缝线的设计中,仍存在改进的需求和期望,从而能消除各种通常的限制。例如,通过切入缝线本体中而形成的保持器具有有时平置,即不随意竖立或散开的趋势。另外,用于制造自留缝线的许多现有技术(例如,切削技术)可能减小缝线的抗拉强度,如下文说明的。
B.传统形成的保持器
图1显示了典型自留缝线100的一部分的透视图,该自留缝线100包括缝线本体102和从该缝线本体102突出的倒刺状保持器104。这里,保持器104通过例如使用切削刀片在缝线本体102中形成切口106而形成。如从图1中能认识的,在沿缝线本体102从缝线本体102切削保持器104(即,形成切口106)的位置处,缝线本体102的直径从d1减小到d2。如同强度仅取决于最弱链节的链条一样,缝线100的抗拉强度可能由于直径的减小以及集中在每个切口106的顶点108处的应力而降低。
C.由热接触介导的保持器
图2A显示了根据本发明一实施例的自留缝线200的一部分的透视图,该自留缝线200包括细长线状缝线本体202和多个从该缝线本体202突出的保持器204。图2B是该自留缝线200的侧视图。这里,保持器204通过使细长缝线本体202的外围203的部分短暂地与一个或多个受热元件(作为元件220示出)接触而形成。当此受热元件220接触缝线本体202时,将导致缝线本体202的局部熔融。换句话说,缝线本体202的与受热元件接触的部分将熔融,这部分也可能是缝线本体的靠近接触点的一小部分。此后,当受热元件220移离缝线本体202(和/或缝线本体202移离受热元件)时,一些熔融的缝线本体将激起而例如形成大致圆锥形倒刺的形状,从而当冷却(主动冷却或允许冷却回到环境温度)时形成保持器204。由于保持器形成的方式,也能将保持器204称为由热接触介导的保持器204。
在图2A和图2B中,受热元件220显示为包括最远部或尖端222,该最远部或尖端222能是受热元件220的与缝线本体202的周界203短暂接触的部分。尖端222的形状和/或尺寸能影响使用受热元件220形成的保持器204的形状和尺寸。例如,所有其它条件相等,尖端224的直径越小,使用该尖端形成的保持器204的直径就越小,而尖端22的直径越大,使用该尖端形成的保持器204的直径就越大。尖端222的形状能影响使用该尖端222形成的保持器204的形状,尖端222的示例性形状包括圆形、方形、三角形、V形、O形,但不限于此。还可能是,受热元件220的除其尖端222之外的部分短暂地接触细长缝线本体202以形成保持器204。
参照图2C,O形尖端222能通过外腔230b内的内腔230a来提供。外腔230b能被加热,而在受热元件220不接触缝线本体时的时期期间,通过构造内腔230a来分配高压空气或某种其它气体,内腔230a能用于清洗尖端222。可替代地或另外地,内腔230a能提供真空吸力来帮助拉起缝线本体的熔融部以帮助形成保持器204。在另一实施例中,内腔230a能分配熔融材料,而在熔融材料的分配期间或恰好之前,外腔230b能被加热(或反之亦然)并接触缝线本体204的外围203。当此加热的外腔230b(或加热的内腔230a)接触缝线本体202时,将导致缝线本体202的局部熔融。此后,当加热腔移离缝线本体202(和/或缝线本体202移离加热腔)时,一些熔融的缝线本体可能与所分配的熔融材料(由另一腔分配)混合,在缝线本体与所形成的保持器204之间提供坚固的结合。此双腔实施例不限于与O形尖端222一起使用,其它形状的腔(例如,三角形、椭圆形、方形等)也能使用。此外内腔和外腔能具有不同的形状,从而产生混合形状的尖端222。
在一实施例中,受热元件220(其也能称为受热元件)包括电阻元件,该电阻元件例如通过焦耳加热的过程将电转化为热。受热元件220例如能由镍铬合金制成或者能是沉积在陶瓷上的金属,但不限于此。受热元件220能例如是Calrod,其是密封在坚硬金属外壳内部的陶瓷粘合剂中的细的镍铬合金线圈。可替代地,受热元件220能由正温度系数(PTC)陶瓷,例如钛酸钡或钛酸铅复合物制成。可替代地,受热元件220能由稀有材料,包括铂、二硅化钼和碳化硅制成。这些仅是少许示例,不意味着限制。
此外通过受热元件220的接触和收回的速度和/或加速度、受热元件220的温度、接触期间的压力以及接触的持续时间能影响并从而控制所产生的保持器204的形状和尺寸。
尽管仅显示了两个保持器204,但是这仅用于简单示例的目的。可能的是图2A和图2B的缝线200以及其余附图的缝线能包括数百个保持器204,尽管或多或少也是可能的。保持器204的周期性和配置能是随意的或有组织的以使组织接合强度最大化或以另外的方式调节组织接合强度。此外注意的是这些附图不一定是按比例绘制的,即可能的是保持器204相对于缝线本体202不如显示的那么大。
通过相对于彼此移动细长缝线本体202和/或受热元件220,受热元件220和缝线本体202能彼此处于接触,从而受热元件220与细长缝线本体202的周界203处于接触并局部熔融该细长缝线本体202的一部分。换句话说,受热元件220能朝着缝线本体202移动,缝线本体202能朝着受热元件220移动,或者两者朝着彼此移动。此后,细长缝线本体202和/或受热元件220相对彼此移动(例如,一个远离另一个),使得受热元件220不再与细长缝线本体202的周界203处于接触,并且使得细长本体的熔融部的至少一些从周界203突出并当冷却时形成保持器204。
参照图3A-3D更详细地示出了上述过程。更具体地,图3A显示受热元件220朝着细长缝线本体202移动。图3B显示受热元件220的尖端222接触细长缝线本体202的周界203,这将导致本体202的近邻接触点的部分熔融。图3C显示受热元件220移离缝线本体202,而一些熔融的缝线本体材料被拉离周界203并且开始形成保持器204。图3D显示随着受热元件220进一步移离缝线本体202,熔融的缝线本体材料将与受热元件220分开。当冷却时,所产生的局部激起或拉起的缝线材料形成最终的保持器204。在一些实施例中,能使用刀片等例如通过将材料从受热元件切掉来将熔融的缝线本体(例如,用于形成保持器的部分)与受热元件220分离。此外,能使用刀片等来清理掉受热元件220的熔融材料。尽管缝线本体202能具有圆形横截面,但这不是必须的,并且术语“圆周”和“圆周的”的使用并意味着圆形横截面。例如,可替代地,缝线本体202的横截面能是椭圆形、方形、三角形、八角形或任意其它规则的几何形状。可替代地,缝线本体的横截面能是任意的形状,其沿缝线本体的长度改变,以便于与组织的更好接合。
受热元件接近和/或移离缝线本体202的角度能影响所产生的保持器204的角度。例如,如果缝线本体202是静态的,而受热元件220以锐角α朝着和远离缝线本体202移动,则所产生的保持器204将相对于细长缝线本体202的纵向轴大致具有α的角度,如从图3D中能认识的。
通过反复使用相同的受热元件形成所有的保持器204能形成多个保持器204。可替代地,能使用多个受热元件,从而同时形成多个保持器204。例如,参照图4,多个受热元件220中的至少一些能是从公共导热本体402延伸的导热元件420,这里当导热本体402被加热时,导热元件420被加热。导热元件420和导热本体402能例如由导热金属或某些其它导热材料制成。
在特定实施例中,受热元件220能朝着和远离细长缝线本体202移动,而细长缝线本体202不移动,从而受热元件220短暂地接触细长缝线本体202。在其它实施例中,细长缝线本体202在第一方向上(由图5A和图5B中的箭头502示出)移动,并且当该细长缝线本体在该第一方向502上移动时,受热元件220在第二方向上(由图5A和图5B中的箭头504示出)朝着细长缝线本体202移动,该第二方向504相对于第一方向502成一定角度。第二方向504能通常垂直于第一方向502,如图5A中所示。可替代地,第二方向504能相对于第一方向502成钝角或锐角,如图5B中所示。在这些实施例中,如上文讨论的其它因素(例如,接触的持续时间、接触压力、受热元件接触部的形状和尺寸、受热元件的移动速度和/或加速度等)一样,细长缝线本体202移动的速度也能影响所产生的保持器204的尺寸和形状。
本发明的实施例的益处在于保持器204能形成在具有相对小的直径的缝线本体202上,而在此具有相对小直径的缝线本体202的情形中,使用传统的切削技术难以形成进入本体202中的切削保持器。另外,尽管缝线本体202的直径在保持器的位置处可能减小(由于缝线本体202的部分用于制造保持器),但是该直径的减小将很可能小于将保持器切入缝线本体202中的情形。此外,具有由热接触介导的保持器的缝线也更平滑并且不包括切口和由切口导致的应力点(应力集中的区域),所有这些情形都能用于保持缝线的高抗拉强度。换句话说,切口以及切口的顶点的不存在消除了以其它方式将存在的应力集中效应并进一步有助于保持缝线的初始抗拉强度。
图6中显示了包括变尺寸的由热接触介导的保持器204的自留缝线200的侧视图。例如,保持器204a彼此紧密间隔并且尺寸相对小,与保持器204b相比具有相对短的长度,所述保持器204b的尺寸相对中等,与保持器204c相比具有相对中等的长度,所述保持器204c的尺寸相对大,具有相对长的长度。这些保持器的周期性能是随意的或有组织的,从而例如保持器204a分组地连续存在,然后继之以分组地连续存在的保持器204b,继之以保持器204c。组的存在的顺序和尺寸可是变化的以使组织接合强度最大化。图6的自留缝线200能通过使用不同尺寸的受热元件220、不同的温度、不同的接触和收回速度和/或加速度、不同的接触压力和/或接触的持续时间等制造。不同尺寸的由热接触介导的保持器204设计用于各种外科应用。保持器尺寸也可在横向方向上改变,由此保持器的基部可以是短的、中等的或长的,并且无论如何,缝线基部通常小于缝线直径的大约1/4。例如,相对较大或较长的由热接触介导的保持器204c对于连接脂肪组织和软组织是理想的,而相对较小或较短的由热接触介导的保持器204a对于连接纤维组织是理想的。大、中和/或小尺寸的保持器在同一缝线上的组合使用有助于当为每个组织层定制保持器尺寸时确保最大的锚固属性。仅两个不同尺寸组的保持器(未示出)可形成到缝线本体202,或者根据预期的最终用途,具有不同于如所示的三种尺寸的四个、五个、六个或多个不同尺寸组的另外保持器组(未示出)可任意地形成到缝线本体202。
在形成之后,例如使用与US专利No.5,007,922中讲授的相似的技术,例如通过保持器204的适当退火循环(加热到特定温度并以特定速度冷却),能对由热接触介导的保持器204进行处理以提高保持器的硬度和强度,该专利通过参引合并于此。
保持器204和缝线本体202均可由生物可吸收材料制成,提供了该材料的示例。可替代地,保持器204和缝线本体202均可由不可吸收的材料制成,该材料的示例也在上文提供。在本发明的另一实施例中,保持器204和缝线本体202能是部分生物可吸收的。
由热接触介导的保持器204能成角度或倾斜为使得当在一个缝线布置方向上拉缝线200时,保持器基本屈从于细长缝线本体202在组织内的运动,而如果在相反的缝线布置方向上拉缝线200,则抵抗运动。自留缝线能具有单向或双向的由热接触介导的保持器204。如果是单向的,则自留缝线能包括末端和相对端,该末端是尖的或具有针以当通过末端拉缝线时,该末端能够穿透并通过该组织,在一些实施例中,该相对端包括锚定器,该锚定器用于在最初插入点处与组织接合以限制缝线的移动。如果是双向的,则自留缝线能包括分组的并且沿缝线的一个部分朝着一个布置方向延伸的保持器以及分组的并且沿缝线的另一部分朝着相反的布置方向延伸的相对保持器。因此,当植入此双向缝线时,两组保持器与组织接合,并且保持器能抵抗缝线通过组织在任一方向上的移动。此外,双向缝线能在缝合线的每端处配有针。双向缝线还能具有位于两组保持器之间的过渡部分。
图7的高级流程图概括了如何能够根据本发明的具体实施例来制造缝线。参照图7,在步骤702处,提供细长缝线本体,这里该细长缝线本体具有第一端、第二端和周界。在步骤704处,通过使细长缝线本体的周界与一个或多个受热元件短暂地接触来在该细长本体上形成保持器。另外,由热接触介导的保持器能形成在细长缝线本体的一端或两端处,例如以形成锚固式保持器。
如上所述,保持器204能形成为使得当在第一方向拉细长缝线本体时,保持器基本屈从于该细长缝线本体在组织内的运动,而抵抗细长本体在与该第一方向相反的第二方向上的运动。在具体实施例中,能形成双向缝线。更具体地,细长缝线本体能包括第一纵向部和第二纵向部。步骤704能包括形成从第一纵向部并沿该第一纵向部延伸的第一组由热接触介导的保持器,使得当在第一方向上拉该细长缝线本体时,该第一组由热接触介导的保持器基本屈从于细长缝线本体在组织内的运动,而抵抗细长缝线本体在与该第一方向相反的第二方向上的运动。此外步骤704能包括形成从第二纵向部并沿该第二纵向部延伸的第二组由热接触介导的保持器,使得当在第二方向上拉该细长缝线本体时,该第二组由热接触介导的保持器基本屈从于细长缝线本体在组织内的运动,而抵抗细长缝线本体在与该第一方向上的运动。
细长缝线本体202能通过任意合适的方法制造,包括但不限于注射成型等。细长缝线本体202能具有单丝结构或编织结构。如上文说明的,编织缝线指多丝缝合线,这里此缝合线中的丝线通常编织、缠绕或编结在一起。本发明的实施例的优点在于保持器204能形成在此多丝式缝线上,而由于丝线中的个体股线的小尺寸,所以切入此类型的缝线中(而以传统方式形成保持器)即使可能,也可能是困难的。
包括缝线本体202和由热接触介导的保持器204的缝线200能由任何合适的生物相容材料制成,并且可利用任何合适的生物相容材料进行进一步处理,从而或者增强缝线的强度、弹性、寿命或其它特性,或者使缝线能够实现除了将组织连接在一起、重定位组织或将外来元件附接到组织之外的附加功能。
在本发明的一具体实施例中,复合缝线丝通过共挤出两种材料产生以形成具有由第一或内部材料制成的芯部和由第二或外部材料形成的外部的共挤出细长缝线本体。内部材料经优选选择为使得它具有出色的拉伸性质和弹性性质,而外部材料选择为实现具有预期硬度的由热接触介导的保持器的形成。在一具体实施例中,外部材料比内部材料具有更高的弹性常数,从而通过使外部材料与一个或多个受热元件短暂接触而形成由热接触介导的保持器来允许形成相对坚硬的保持器。此外外部材料可比内部材料具有更大的塑性区域以实现外部材料的更容易的永久变形。内部材料优选比外部材料更有弹性,使得与通过从单一材料丝线切削保持器形成的类似缝线相比,具有由热接触介导的保持器的缝线具有增强的保持器特征、缝线柔性和抗拉强度的组合。
此处所述的缝线200还可包括进一步促进组织接合的材料。例如,形成组织接合促进材料的缝线200能增强缝线保持在适当位置的能力。一个此类的组织接合促进材料是能进行挤出以形成缝线本体的多孔聚合物,包括多微孔聚合物和能利用气泡挤出的聚合物(无论是生物可吸收的还是生物不可吸收的)。利用这些材料合成的缝线200能具有三维晶格结构,其增加了组织接合的表面面积并且允许组织渗入缝线本体本身中,因而具有促进成功的缝线使用的一级结构。此外,通过优化孔的尺寸,能促进纤维原细胞的向内生长,进一步有助于保持器204在组织中的锚固。可替代地,可使用致纤维涂层或制剂来促进保持器204的更具纤维性的组织包裹,并因此促进更好的接合。能用于形成保持器204和/或能应用于保持器204以促进组织生长的示例性致纤维材料在发明名称为“Medical implants and fibrosis-inducing agents”的US专利No.7,166,570中公开,该专利通过参引合并于此。
一种此多微孔聚合物是ePTFE(膨体聚四氟乙烯)。包括ePTFE(和相关多微孔材料)的自留缝线非常适合需要强大和永久提升(诸如胸部提升、面部提升和其它组织重定位手术)的用途,因为缝线的组织渗透导致缝线和周围组织的改进的固定和移植,因而提供该提升的更好固定和更长寿命。
另外,此处所述的自留缝线可设有用以促进康复和防止不合意的效果,诸如伤疤形成、感染、疼痛等的合成物。这能以各种方式实现,例如包括:(a)通过直接将缝线附于配方(例如,或通过利用聚合物/药物薄膜喷射缝线,或通过将缝线浸入聚合物/药物溶液中),(b)通过利用诸如水凝胶的物质涂覆缝线,该水凝胶将吸收合成物,(c)在多丝缝线的情形中,通过将按配方涂覆的线(或形成线的聚合物本身)交织成缝线结构,(d)通过将缝线插入包括或涂覆有配方的套管或网眼中,或(e)利用合成物构造缝线本身。这些合成物可非限制地包括抗增生剂、抗血管生成剂、抗感染剂、纤维诱发剂、抗疤痕剂、润滑剂、回声剂、抗炎症药、细胞周期抑制剂、镇痛药和抗微管剂。例如,合成物能在保持器形成之前应用于缝线,从而当保持器接合时,接合面基本无涂层。这样,当引入缝线时,缝合的组织接触缝线的涂覆表面,但当保持器接合时,保持器的非涂覆表面接触该组织。可替代地,例如如果期望完全涂覆而不是选择性涂覆的缝线,则可在保持器在缝线上形成之后或期间对缝线进行涂覆。在又一备选方案中,缝线可在保持器的形成期间或之后通过仅使缝线的选定部分暴露于涂层来进行选择性地涂覆。放置缝线或合成物可确定是完全涂覆还是选择性涂覆的缝线的特定目的是适当的;例如,利用润滑涂层,选择性地涂覆缝线,例如保留缝线的组织接合面不涂覆以便防止这些表面的组织接合功能被削弱可能是合意的。另一方面,那些包括诸如抗感染剂的化合物的涂层可适当地涂覆到整个缝线,而诸如那些包括纤维化制剂的涂层可适当地涂覆到缝线的全部或部分(诸如组织接合面)。此外缝线的目的可确定涂覆到缝线的涂层的种类;例如,具有抗增生涂层的自留缝线可在封闭肿瘤切除位置中使用,而具有纤维化涂层的自留缝线可在组织重定位手术中使用,而具有抗疤痕涂层的自留缝线可用于皮肤上的伤口闭合。此外,缝线的结构可影响涂层的选择和范围;例如,具有膨胀部的缝线可包括位于该膨胀部上的纤维诱发合成物以进一步固定该部分在组织中的适当位置。涂层还可包括多种合成物,所述多种合成物或者在一起或者在缝线的不同部分上,这里多种合成物能或者选择用于不同的目的(诸如镇痛、抗感染和抗疤痕剂的组合)或者用于其协同效应。
D.临床应用
除了在先前部分中描述的通常的伤口闭合和软组织修复应用之外,自留缝线能在各种其它适应症中使用。
此处所述的自留缝线可在各种牙齿手术,即口腔和颔面外科手术中使用,因而可称为“自留牙科缝线”。上述手术包括但不限于口腔手术(例如,阻生牙或坏牙的去除)、用以提供骨增强的手术、用以修复齿颚颜面畸形、修复伴随创伤(例如,颜面骨骨折和损伤)的手术、牙源性肿瘤和非牙源性肿瘤的手术治疗、整形手术、唇裂或颚裂的修复、先天性颅面畸形和面部美容手术。自留牙科缝线可以是可降解的或不可降解的,并且尺寸可通常在从USP 2-0到USP 6-0的范围中。
此外此处所述的自留缝线可在组织重定位的外科手术中使用并因而可称为“自留组织重定位缝线”。这些外科手术非限制地包括面部提升、颈部提升、额头提升、股提升和胸部提升。在组织重定位手术中使用的自留缝线可取决于重定位的组织而改变;例如具有较大和进一步间隔的保持器的缝线可能适于与相对柔软的组织,诸如脂肪组织一起使用。
此外此处所述的自留缝线可在外科手术显微镜下执行的显微外科手术中使用(因而可称为“自留显微缝线”)。这些外科手术包括但不限于外围神经的重附着和修复、脊柱显微手术、手的显微手术、各种整形显微外科手术(例如,面部重建)、男性或女性生殖系统的显微手术以及各种类型的重建显微手术。当其它选择,诸如一期缝合、通过二次愈合的康复、皮肤移植、局部皮瓣转移和远距离皮瓣转移不合适时,使用显微外科重建用于复杂的重建手术问题。自留显微缝线具有非常小的口径,经常小到USP 9-0或USP 10-0,并且可具有对应尺寸的附接针。它们可以是可降解或不可降解的。
此处所述的自留缝线可在用于眼部外科手术的类似小口径范围中使用并因而可称为“眼科自留缝线”。这些手术包括但不限于角膜移植术、白内障和玻璃体视网膜显微外壳手术。眼科自留缝线可以是可降解或不可降解的,并且具有对应小口径的附接针。
自留缝线能在各种针对动物健康的许多手术和创伤的兽医应用中使用。
尽管已关于本发明的若干示例性实施例对本发明进行了显示和描述,但是本领域中的技术人员应当理解的是不预期将本发明限于所公开的具体实施例。在不实质上偏离本发明的新颖教义和优点的情况下,特别是根据前述教义,可对所公开的实施例作出各种修改、省略和添加。因此,预期覆盖所有这些可包括在权利要求限定的本发明的精神和范围内的修改、省略、添加和等同物。

Claims (16)

1.形成用在施用于组织的外科手术中的缝线的方法,包括:
(a)提供细长缝线本体;以及
(b)通过使所述细长缝线本体与一个或多个受热元件短暂接触来在所述细长缝线本体上形成保持器,
其中步骤(b)包括:
(b.1)相对于彼此移动所述细长缝线本体和所述受热元件中的至少一个,使得所述受热元件与所述细长缝线本体处于接触并且熔融所述细长缝线本体的一部分;以及
(b.2)相对于彼此移动所述细长缝线本体和所述受热元件中的至少一个,使得所述受热元件不再与所述细长缝线本体处于接触,以及使得所述细长缝线本体的所述熔融部分的至少一些从所述细长缝线本体突出并在冷却时形成所述保持器。
2.形成用在施用于组织的外科手术中的缝线的方法,包括:
(a)提供细长缝线本体;以及
(b)通过使所述细长缝线本体与一个或多个受热元件短暂接触来在所述细长缝线本体上形成保持器,其中步骤(b)的所述细长缝线本体与所述一个或多个受热元件的短暂接触执行为使得所述保持器相对于所述缝线本体成锐角形成并且指向所述细长缝线本体的第一端,从而当在所述细长缝线本体的第二端处拉所述细长缝线本体时,所述保持器屈从于所述细长缝线本体在所述组织内的运动,而当在所述第一端处拉所述细长缝线本体时,所述保持器抵抗所述细长缝线本体在组织内的运动。
3.形成用在施用于组织的外科手术中的缝线的方法,包括:
(a)提供细长缝线本体;以及
(b)通过使所述细长缝线本体与多个受热元件短暂接触来在所述细长缝线本体上形成保持器,其中步骤(b)包括使所述细长缝线本体与多个受热元件短暂接触,从而同时形成多个所述保持器。
4.根据权利要求3所述的方法,其中所述多个受热元件中的至少一些是从公共导热本体延伸的导热元件,并且其中当所述导热本体被加热时,所述导热元件被加热。
5.形成用在施用于组织的外科手术中的缝线的方法,包括:
(a)提供细长缝线本体;以及
(b)通过使所述细长缝线本体与一个或多个受热元件短暂接触来在所述细长缝线本体上形成保持器,其中步骤(b)包括:
(b.1)朝着所述细长缝线本体移动所述受热元件,而所述细长缝线本体不移动,使得所述受热元件与所述细长缝线本体处于接触并且熔融所述细长缝线本体的一部分;以及
(b.2)将所述受热元件移离所述细长缝线本体,使得所述受热元件不再与所述细长缝线本体处于接触,以及使得所述细长缝线本体的所述熔融部分的至少一些从所述细长缝线本体突出并在冷却时形成所述保持器。
6.形成用在施用于组织的外科手术中的缝线的方法,包括:
(a)提供细长缝线本体;以及
(b)通过使所述细长缝线本体与一个或多个受热元件短暂接触来在所述细长缝线本体上形成保持器,其中步骤(b)包括:
(b.1)在第一方向上移动所述细长缝线本体;
(b.2)在所述细长缝线本体在所述第一方向上移动的同时,在第二方向上朝着所述细长缝线本体移动所述受热元件,所述第二方向相对于所述第一方向成一定角度,使得所述受热元件与所述细长缝线本体处于接触并且熔融所述细长缝线本体的一部分;以及
(b.3)将所述受热元件移离所述细长缝线本体,使得所述受热元件不再与所述细长缝线本体处于接触,以及使得所述细长缝线本体的所述熔融部分的至少一些从所述细长缝线本体突出并在冷却时形成所述保持器。
7.根据权利要求6所述的方法,其中所述第二方向垂直于所述第一方向。
8.根据权利要求6所述的方法,其中所述第二方向相对于所述第一方向成钝角或锐角。
9.形成用在施用于组织的外科手术中的缝线的方法,包括:
(a)提供细长缝线本体;以及
(b)通过使所述细长缝线本体与一个或多个受热元件短暂接触来在所述细长缝线本体上形成保持器,其中步骤(b)包括控制所述受热元件与所述细长缝线本体处于接触的速度和/或加速度以及所述受热元件收回的速度和/或加速度以影响使用所述受热元件形成的所述保持器的形状和/或尺寸。
10.形成用在施用于组织的外科手术中的缝线的方法,包括:
(a)提供细长缝线本体;以及
(b)通过使所述细长缝线本体与一个或多个受热元件短暂接触来在所述细长缝线本体上形成保持器,其中步骤(b)包括控制所述受热元件与所述细长缝线本体之间的接触的持续时间以影响使用所述受热元件形成的所述保持器的形状和/或尺寸。
11.形成用在施用于组织的外科手术中的缝线的方法,包括:
(a)提供细长缝线本体;以及
(b)通过使所述细长缝线本体与一个或多个受热元件短暂接触来在所述细长缝线本体上形成保持器,其中步骤(b)包括控制所述受热元件与所述细长缝线本体处于接触的压力以影响使用所述受热元件形成的所述保持器的形状和/或尺寸。
12.形成用在施用于组织的外科手术中的缝线的方法,包括:
(a)提供细长缝线本体;以及
(b)通过使所述细长缝线本体与一个或多个受热元件短暂接触来在所述细长缝线本体上形成保持器,包括控制所述受热元件的温度以影响使用所述受热元件形成的所述保持器的形状和/或尺寸。
13.形成用在施用于组织的外科手术中的缝线的方法,包括:
提供细长缝线本体;
使所述细长缝线本体与受热元件接合以熔融所述细长缝线本体的一部分;以及
使所述受热元件与所述细长缝线本体脱离,使得所述本体的熔融部突出并且在冷却时形成保持器。
14.根据权利要求13所述的方法,其中所述细长缝线本体包括多条编织、缠绕或编结在一起的丝线。
15.用在施用于组织的手术中的缝线,其通过如权利要求1至14中任一项所述的方法形成,所述缝线包括:
细长缝线本体;以及
多个由热接触介导的保持器,其沿所述细长缝线本体的至少一部分布置。
16.权利要求1-12任一项的方法,其中,所述细长缝线本体是双重挤出的细长缝线本体,其包括由第一材料形成的芯部和由第二材料形成的外部,其中所述第二材料比所述第一材料具有更高的弹性常数和/或更大的塑性区域。
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US8771313B2 (en) 2014-07-08

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