CN100444905C - 自动缝合器用缝合补缀材料 - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
- A61B2017/0477—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery with pre-tied sutures
Abstract
本发明涉及适用于外科手术等中广泛使用的自动缝合器的筒状缝合补缀材料，其提高了筒状化的生产率，且易于进行拆线操作。目的在于解决由现有的临时接合引起的脱落、由串缝产生的生产率低下和熟练的课题，由于薄片状体的种类、缝合距离而不能顺利地拆线的课题。具体地说涉及一种自动缝合器用缝合补缀材料，在缝合薄片状体的两端部而形成筒状的自动缝合器用缝合补缀材料的构成中，特征在于，以由一根线构成的单线链形缝法作为其缝合方法，并适当延伸出缝合结束处的线头。
Description
技术领域
本发明涉及适用于外科手术等中广泛使用的自动缝合器的筒状缝合补缀材料，易于筒状化且生产率高，并且容易实现拆线操作的筒状缝合补缀材料。
背景技术
以往，埋设有多个缝合钉的订书器式自动缝合器用于组织的缝合，但在对肺部等的适用当中，会出现从缝合部漏气的问题，还有在对软组织的适用当中，曾出现过组织的损伤、破裂等问题。
对于这种课题，本申请人以该防止漏气、加固为目的，对于安装在缝合钉部而使用的筒状缝合补缀材料，已经提出了多项申请(例如，日本国实用新型登记第2604025号公报、日本国专利第3136392号公报、日本国专利第3237749号公报、日本国专利第3237750号公报、日本国特开平9-24050号公报、日本国特开平9-308635号公报、日本国特开2000-157622号公报、日本国特开2000-316963号公报、日本国特开2001-70433号公报)。
此外，作为由其他申请人申请的关于筒状缝合补缀材料的申请，还有日本国专利第3040930号公报、日本国特开平8-299427号公报等。
上述申请中，例如揭示了由生物体内分解吸收性原料构成的无纺布或薄膜等薄片状体形成为筒状的构成、或者组合由生物体内分解吸收性原料构成的无纺布和伸缩性编织物而形成为筒状的构成等。对进行这样的筒状化而言，揭示有临时轻轻地接合重叠的薄片状体的两端部(两耳部)的方法、临时粗略缝合重叠的薄片状体的两端部的方法。具体讲，揭示了在重叠的薄片状体的表面和里面相互运针的串缝方法。
这样临时接合或临时缝合薄片状体，是为了通过装有缝合补缀材料的自动缝合器缝合患处，并从正常组织部中分离病变部后，在将病变部清除到体外时，能够容易分离与病变部一起取出的补缀材料的部分、和留在体内的补缀材料的部分。
但是，存在如下课题，即在由这样的临时接合方法制造的筒状缝合补缀材料中，薄片状体容易脱落，此外在由串缝方法制造的筒状缝合补缀材料中，缝制需要时间和熟练，此外由于薄片状体的种类、缝合间距等的不同而难于顺利地拆线。
发明内容
本发明是解决了这样的课题的制品，提供一种不需要高度的技术即可制造的、且与补缀材料的原料或缝合间距无关地能够极其顺利地进行从补缀材料的拆线的新型自动缝合器用缝合补缀材料。
并且，本发明的特征在于以下构成。
项1.一种自动缝合器用缝合补缀材料，缝合薄片状体的两端部而形成筒状，其特征在于，其缝合方法为由一根线构成的单线链形缝法，并适当延伸出缝合结束处的线头。
项2.根据项1所述的自动缝合器用缝合补缀材料，其特征在于，将前端部缝合成尖细状或袋状而形成。
项3.根据项1或2所述的自动缝合器用缝合补缀材料，其特征在于，前述薄片状体的至少一部分，使用选自由生物体内分解吸收性原料构成的编织物、纺织物、无纺布及薄膜所组成的组中的至少一种。
项4.根据项1所述的自动缝合器用缝合补缀材料，其特征在于，将前述薄片状体和具有伸缩性的编织物或纺织物一体化并形成筒状。
项5.根据项1～4任意一项所述的自动缝合器用缝合补缀材料，其特征在于，在构成筒状的薄片状体的缝合结束侧端部设置有手捏部。
项6.根据项1～4任意一项所述的自动缝合器用缝合补缀材料，其特征在于，延伸出的缝合结束的线头彼此之间被连接成环状。
项7.根据项1～4任意一项所述的自动缝合器用缝合补缀材料，其特征在于，在延伸出的线头的环中插入阻塞物，以防止开线。
项8.根据项1～4任意一项所述的自动缝合器用缝合补缀材料，其特征在于，将延伸出的线头插入到与该线头连接的前一个环，以防止开线。
项9.根据项1～4任意一项所述的自动缝合器用缝合补缀材料，其特征在于，将缝合结束侧的一个环与其前一个环打结，以防止开线。
项10.一种自动缝合器用缝合材料的制作方法，缝合薄片状体的两端部而形成筒状，其特征在于，通过由一根线构成的单线链形缝法缝合该薄片状体的两端部形成筒状，并适当延伸出缝合结束处的线头。
项11.一种自动缝合器，具备内藏缝合钉的夹头部和具有缝合钉接收槽的机架部，其特征在于，在该夹头部及/或该机架部安装项1～9任意一项所述的自动缝合器用缝合材料来构成。
附图说明
图1表示构成本发明的缝合方法的模式图。
图2表示构成本发明的缝合方法的模式图。
图3表示构成本发明的缝合方法的模式图。
图4表示构成本发明的缝合方法的模式图。
图5表示构成本发明的缝合方法的模式图。
图6表示构成本发明的缝合方法的模式图。
图7表示构成本发明的缝合方法的模式图。
图8表示举例表示本发明构成的立体图。
图9表示举例表示本发明的其它构成的立体图。
图10表示安装有本发明的缝合补缀材料的自动缝合器的正面图。
图11表示将图10中本发明的缝合补缀材料安装在自动缝合器的状态的部分扩大正面图。
图12表示举例表示本发明的其它构成的立体图。
图13举例表示本发明的防止线头开线的立体图。
图14举例表示本发明的其它防止线头开线的立体图。
图15举例表示本发明的其它防止线头开线的立体图。
图16表示举例表示设置有本发明的手捏部的构成的立体图。
符号说明如下：
1：缝合起始线头 2：缝合结束线头 3：环
4：筒状缝合补缀材料 5：生物体内分解吸收性无纺布
6：弹性针织物质地 7：表侧缝眼 8：里侧缝眼
9：阻塞物 10：自动缝合器 11：夹头部
12：机架部 13：纽结 14：手捏部 15：纽结
具体实施方式
下面详细说明本发明。
构成本发明的薄片状体从以下材料中适当选择来制造，即：聚酰胺、聚酯、硅、氟素树脂等生物体内非吸收性的原料，及聚乙二醇酸、聚乳酸、乙二醇酸和乳酸的共聚体、乳酸和己内酯的共聚体、乙二醇酸和己内酯的共聚体或它们的混合物、还有聚对二氧环己酮、聚己内酯、甲壳质、动物组织等生物体内可分解吸收的原料。作为该薄片状体的形态，可以例举由上述生物体内非吸收性原料、及/或生物体内分解吸收性原料构成的编织物、纺织物、无纺布、薄膜、薄片、海绵薄片等。
尤其作为优选形态，可以例举在柔软性、通气性、弹性、厚度、吸血性、缝合线的形成性、加水分解性等方面出色的、以聚乙醇酸为原材料的无纺布。这样的无纺布可以通过针轧法、熔喷法等任意方法制造。
本发明的缝合补缀材料，是将一张薄片状体卷曲并缝合其两端部，或者重叠两张薄片状体并缝合其两端部而形成筒状。重叠两张薄片状体形成筒状时，其中一张薄片状体可以是具有伸缩性的薄片状体。在这里，作为具有伸缩性的薄片状体，优选例举其组织中适当掺杂编织橡胶线、聚氨酯系弹性线、精制卷缩线、超尺寸加工线等，且在纵向及/或横向上具有伸缩性的编织质地或纺织质地。如这样，与伸缩性质地组合的缝合补缀材料时，容易进行对自动缝合器的安装、安装后的校正操作(位置修正)等。
另外，对于这种伸缩性薄片状体的编织组织虽然没有特别限制，但是从剪断作业、筒状体形成时的缝合作业的容易性，形态稳定性等方面考虑，可以例举出，使用以尼龙线包裹聚氨酯线而得到的伸缩性线，编成经编组织的弹性针织物质地。
上述薄片状体的筒状化，在使用一张薄片状体时，可通过将对应于缝合器的外周尺寸而剪断的质地卷曲并缝合其两端部来进行。此外，使用两张薄片状体时，通过将两者重叠并缝合其两端部彼此来进行。
另外，本发明中所谓“筒状”，表示薄片状体的两端部接合成一体，也可以是圆筒状、棱柱体、平面状中的任意形态。
这种缝合可举出：将两端并行缝合的方法、将前端部形成尖细状的缝合方法、将前端部形成袋状的连续缝合的方法等，且可以任意选择。另外，前端部是尖细或袋状的话，有容易安装在缝合器上的优点。
这种缝合所使用的缝线，虽然可以直接使用通常衣服等的缝合所使用的线，但是特别是从医疗用途的特殊性，考虑到误残留在体内的医疗场合的话，则优选使用例如由聚乙二醇酸、乙二醇酸/乳酸的共聚体、乳酸和己内酯的共聚体等形成的生物体内分解吸收性的缝合线。
本发明就其缝合方法而言，其特征是由一根线(针线)构成的单线链形缝法。所谓由该一根线构成的单线链形缝法，是仅通过一根线形成环的缝眼。
虽然本发明的缝合方法的具体例表示在图1～图7，但并不局限于此。另外，下面使用的所谓“针侧”是刺入重叠的薄片状体的针的一侧，即意味着各图的上侧，所谓“里侧”是与刺入重叠的薄片状体的针的一侧相反的一侧，即意味着各图的下侧。此外，图1～图6中，省略了重叠的薄片状体。
图1是环3从针侧穿过薄片状体，在薄片状体的里侧单线成环的例子。另外，本发明中，所谓单线成环表示线的一个环穿过该线的其它环。
图2是环3从针侧进入到薄片状体中，经过薄片状体的一部分后在针侧露出，在下一个针穿透点单线成环的例子。下面，所谓“经过薄片状体的一部分后在针侧露出”，包含围绕重叠的薄片状体的端，并在针侧露出环的情况，和穿过薄片状体在针侧露出环的情况等。
图3是环3从针侧穿过薄片状体，前进少许经过薄片状体在针侧露出，在下一个针穿透点，在薄片状体的针侧单线成环的例子。
图4是环3从针侧进入到薄片状体中，经过该薄片状体的一部分在针侧露出，在缝合形成线上(缝眼线上)的下一个针穿透点单线成环的例子。
图5是图1中缝合方法的变形，形成了锯齿形的样子。
图6是环3从针侧穿过薄片状体的里面，退回少许，并经过薄片状体在针侧露出。该线是下一个环穿过薄片状体单线成环的例子。
图7是环3穿过已经达到薄片状体的针侧的环和薄片状体，进而，该穿过了的环围绕薄片的端部并拉引至下一个针穿透点的例子。
另外，各图中，1表示缝合起始线头、2表示缝合结束线头。此外，图1中3表示环，7表示表侧缝眼，8表示里侧缝眼。
以上的例子都是由一根线(针线)构成的链形缝法，是通过拉伸缝合结束的线头2，从形成的环中抽出线，不受阻碍地解开缝线的缝合方法。这样的缝合方法可以通过手工缝合进行，但也可以用市场销售的缝纫机进行，此时，可以进行极具效率的缝合。
该线头为了容易分离与病变部一起取出的补缀材料部分(例如，弹性针织物质地)和残存在体内的补缀材料部分(例如，生物体内分解吸收性原料)，优选延伸出适当的长度。此外，延伸出的缝合结束的线头彼此也可以连接成轮状。再者，也可以将缝合起始线头打结在薄片状体(例如：弹性针织物质地)上而成为一体，将延伸出的两端的缝合结束线头彼此连接成环状(轮状)。此时，拆线操作极其容易，手术后容易将薄片状体(弹性针织物质地)与缝线一起取出。
另外，为了防止不小心从补缀材料上把线拆掉，也可以在缝合结束线头的环处设置阻塞物，或将该线头穿过与缝合结束线头连接的前环里，或将缝合结束侧的环穿过该环的前一个环，且通过打了一个结的纽结来固定。
作为本发明的缝合补缀材料所适用的自动缝合器，可以例举：U.S.SURGICAL公司制造的多发式直线切割缝合器GIA 80、多发式直线切割缝合器GIA 60、GIA50P、GIA90P；爱惜康(Ethicon/エチコン)公司制造的proximate直线型切割吻合器55mm及75mm；U.S.SURGICAL公司制造的ENDO GIA②30、ENDO GIA②45、ENDO GIA②60；爱惜康(Ethicon/エチコン)公司制造的外科穿刺缝合器(Endopath Endocutter/エンドパスエンドカツタ一)ETS45、EZ45。
本发明的缝合补缀材料在缝合器上的适用，是通过将其被覆(安装)在具有内藏缝合钉的筒部和缝合钉接收槽的机架部的一侧或两侧来进行。
此时，为了容易地将筒状缝合补缀材料安装在自动缝合器上，也可以延长设置构成筒状缝合补缀材料的薄片状体的缝合结束侧端部，并设置手捏部。
下面，对本发明的缝合补缀材料，以例图为基础进行说明，但并不是对本发明进行制。
[实施例1]
图8及图9是分别按照图1中表示的缝合方法形成的本发明的缝合补缀材料，图8是重叠生物体内分解吸收性的无纺布5和具有伸缩性的弹性针织物质地6，将其两端通过ペガサス(公司名)公司制造的DH型环缝缝纫机缝合得到的筒状缝合补缀材料4。此外，图9是卷曲上述的1张无纺布5，将其两端彼此重叠后用与上述相同的缝纫机缝合成环状而得到的、前端部封闭的袋状的筒状缝合补缀材料4。
此外，虽然图中没有表示，但作为图8的变形例，也可以以前端部变细的方式缝合成尖细状的作为本发明的一个形态。
另外，以上例中，为了容易拆线，缝合结束的线头2适当延伸出而设置。
这样得到的缝合补缀材料4，分别如图11所示那样安装在图10所示的自动缝合器10的埋入有缝合钉的夹头部11和机架部12上来使用。另外，在该安装时，安装成延伸出的缝合结束的线头2位于跟前，即位于自动缝合器10的手握侧。
[实施例2]
图12中表示其它构成例。这种构成是，如图8所示，重叠生物体内分解吸收性的无纺布5和具有伸缩性的弹性针织物质地6，且缝合两端而得到的筒状缝合补缀材料的构成，并将缝合起始的线头1打结在弹性针织物质地6上而成一体，连接两端的缝合结束的线头2彼此而形成环状(轮状)。
这种构成中，由于缝合结束的线头2是轮状，因此容易处理，也容易进行拆线操作。此外，由于弹性针织物质地6上打结有缝合起始的线头1，因此有在手术后易于将该部分与缝线一起取出的优点。
[实施例3]
图13及图14中表示防止缝合结束线头2开线的构成例。
图13是在缝合结束线头2的环3中插入阻塞物9的例子。这种阻塞物9可以是线、细条状剪裁的质地、薄膜等，此外也可以是由纤维以外的原料制作的物体。优选的是适当选择使用易于插入且易于抽出的具有弹性的物体。
图14是通过将该线头穿过同样与缝合结束线头2连接的前一个环3，同样是为了防止开线。该操作按照图例①～④的顺序进行，将缝合结束线头2插入到前环3中，最后通过拉伸线头2进行固定。
这样的防止开线方法，使线头2具有无用的牵力，防止线从补缀材料抽出。所以，规定的缝合处理结束后，取出阻塞物或使插入到前一个环3的线头3复原，并通过拉伸进行拆线。
再者，图15中表示了其它防止开线的方法。
这种构成是将缝合结束侧的环3插入到该环的前一个环，且通过打了一次结的纽结15来固定，由此防止环3抽出。即，根据这种构成，特别是可以防止由往夹头部、机架部安装时所附加的张力产生的缝眼的松开。另外，缝合操作结束后，通过拉伸线头而使生物体内分解吸收性无纺布5被损坏，接下来由于缝眼渐渐松开，可以轻易地将缝线与弹性针织物质地6一起取出。
另外，这种开线防止方法除了上述例子外，例如，可以是在薄片状体上涂抹粘接剂，并将线头与薄片状体临时接合，或者粘贴胶带并将线头临时固定在薄片状体上等任意的方法。
[实施例4]
图16中举例表示易于将筒状缝合补缀材料安装到自动缝合器的操作用的构成，即，延长设置构成筒状缝合补缀材料的薄片状体的缝合结束侧端部，并设置有手捏部14的构成。本例中，由于将弹性针织物质地6的缝合结束端部裁剪成凸状，并作为手捏部14，通过抓住该部位进行拉抻，可以轻易将筒状缝合补缀材料安装到自动缝合器。
这样的手捏部14考虑到操作性，可以设定成任意的形状、尺寸。此外，除了裁剪方法以外，可通过任意的方法在弹性针织物质地6上加设手捏部。例如，可以将布、薄膜等其它原料通过粘接、缝合等来加设手捏部。再者，可以在生物体内分解吸收性的无纺布5侧设置手捏部，也可以在两侧都设置手捏部。
本发明的缝合补缀材料具有使用现有的缝纫机等来容易形成缝眼的特点。所以，可以不需要熟练就能制造筒状缝合补缀材料，生产率高，不发生质量偏差。此外，与现有的串缝的缝眼相比，拆线性优良，可以顺利地进行手术后的薄片状体的分离操作。再者，往自动缝合器的安装作业性得到改善，还一并赋予了防止操作中开线的功能。
Claims (8)
1.一种自动缝合器用缝合补缀材料，缝合薄片状体的两端部而形成筒状，其特征在于，其缝合方法为由一根线构成的单线链形缝法，并适当延伸出缝合结束处的线头，将延伸出的线头插入到与该线头连接的前一个环，以防止开线。
2.根据权利要求1所述的自动缝合器用缝合补缀材料，其特征在于，将前端部缝合成尖细状或袋状而形成。
3.根据权利要求1或2所述的自动缝合器用缝合补缀材料，其特征在于，前述薄片状体的至少一部分，使用选自由生物体内分解吸收性原料构成的编织物、纺织物、无纺布及薄膜所组成的组中选择的至少一种。
4.根据权利要求1所述的自动缝合器用缝合补缀材料，其特征在于，将前述薄片状体和具有伸缩性的编织物或纺织物一体化并形成筒状。
5.根据权利要求1、2或4所述的自动缝合器用缝合补缀材料，其特征在于，在构成筒状的薄片状体的缝合结束侧端部设置有手捏部。
6.根据权利要求1、2或4所述的自动缝合器用缝合补缀材料，其特征在于，延伸出的缝合结束的线头彼此之间被连接成环状。
7.一种自动缝合器用缝合材料的制作方法，缝合薄片状体的两端部而形成筒状，其特征在于，通过由一根线构成的单线链形缝法缝合该薄片状体的两端部而形成筒状，并适当延伸出缝合结束处的线头，将延伸出的线头插入到与该线头连接的前一个环，以防止开线。
8.一种自动缝合器，具备内藏缝合钉的夹头部和具有缝合钉接收槽的机架部，其特征在于，在该夹头部及/或该机架部安装权利要求1、2或4所述的自动缝合器用缝合材料来构成。
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- 2004-07-16 JP JP2005511934A patent/JP4675237B2/ja not_active Expired - Fee Related
- 2004-07-16 TW TW093121303A patent/TW200507885A/zh not_active IP Right Cessation
- 2004-07-16 DE DE602004029366T patent/DE602004029366D1/de active Active
- 2004-07-16 ES ES04747929T patent/ES2350912T3/es active Active
- 2004-07-16 DK DK04747929.0T patent/DK1647286T3/da active
- 2004-07-16 EP EP04747929A patent/EP1647286B1/en active Active
- 2004-07-16 KR KR1020107027307A patent/KR20110007244A/ko not_active Application Discontinuation
- 2004-07-16 CN CNB2004800206189A patent/CN100444905C/zh not_active Expired - Fee Related
- 2004-07-16 PT PT04747929T patent/PT1647286E/pt unknown
- 2004-07-16 US US10/564,874 patent/US8177797B2/en active Active
- 2004-07-16 KR KR1020067001056A patent/KR101136114B1/ko active IP Right Grant
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Also Published As
| Publication number | Publication date |
|---|---|
| JP4675237B2 (ja) | 2011-04-20 |
| ES2350912T3 (es) | 2011-01-28 |
| HK1088567A1 (en) | 2006-11-10 |
| WO2005007208A1 (ja) | 2005-01-27 |
| TWI300354B (zh) | 2008-09-01 |
| US8177797B2 (en) | 2012-05-15 |
| EP1647286A1 (en) | 2006-04-19 |
| JP5241802B2 (ja) | 2013-07-17 |
| EP1647286B1 (en) | 2010-09-29 |
| ATE482656T1 (de) | 2010-10-15 |
| JP2011078799A (ja) | 2011-04-21 |
| DK1647286T3 (da) | 2010-11-29 |
| US20060178683A1 (en) | 2006-08-10 |
| CN1822865A (zh) | 2006-08-23 |
| KR20060033913A (ko) | 2006-04-20 |
| PT1647286E (pt) | 2010-11-30 |
| EP1647286A4 (en) | 2007-05-02 |
| KR101136114B1 (ko) | 2012-04-17 |
| KR20110007244A (ko) | 2011-01-21 |
| TW200507885A (en) | 2005-03-01 |
| JPWO2005007208A1 (ja) | 2006-08-31 |
| US20070049953A2 (en) | 2007-03-01 |
| DE602004029366D1 (de) | 2010-11-11 |
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