CN101111196A - 外科手术接合器支撑物材料 - Google Patents
外科手术接合器支撑物材料 Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B17/07292—Reinforcements for staple line, e.g. pledgets
Abstract
一种具有粘性表面的钉合线支撑物材料,该材料以消毒、易于使用形式包装和提供。该材料可用于改进外科手术钉合机,以提供改进的钉合线,同时提高了使用的方便性。
Description
发明领域
本发明涉及外科手术接合器,以及适合于用于与这种外科手术接合器组合件中的支撑物材料。
背景技术
外科手术接合器通常用于外科手术,以实现各种功能,例如除去器官的一部分(例如切除组织),切穿器官和组织(横切),并在结构之间形成连接(形成愈合)。当前,各种外科手术接合器在使用中,这些外科手术接合器包括卡箝填充器(appliers)、外科手术钉合器及其他器械。
外科手术钉合器通常用于各种外科手术操作中,这些外科手术包括血管、肥胖症、泌尿科、妇科、胸科和儿科外科手术。例如,这样的胸科手术:使肺容量减少,其中该手术切除一部分肺以治疗肺气肿或者其他情形。此外,这样的肥胖症手术:是使胃旁路通过,其中该手术切除一部分胃形成较小胃来辅助重量降低。
外科手术钉合器还以许多形式提供,包括直线钉合机、圆形钉合机和波状外形或者曲线钉合机。外科手术钉合机通常包括一对相对的工作面。在直线钉合机情况下,设置两个并列的爪,一个保持钉合机的盒体,另一个为钉合机抵靠其中而待触发的砧座(anvil)元件。当钉合机触发时,它同时从盒体放射多排密集的卡钉,并穿过病人的自身组织。
在有些情况下,已经报道,在钉合线有空气和/或流体渗漏和/或大量出血。在这里使用的术语“钉合线”是指任何被钉合的组织,并且取决于使用钉合机的种类,钉合线可以是直线、圆弧或者曲线。在切割线和/或在钉合孔本身可发生渗漏。常常在胸科手术中,患病的肺组织较薄并且较脆弱,而当肺再充气时可能在钉合处撕开。这些漏气可能很持久,并可使病人住院时间延长数个星期。作为解决这些渗漏问题的手段,外科医生常常通过把支撑物或者纱布材料施加到期望的钉合部位,并且穿过该支撑物材料进行钉合,从而加强钉合线。该支撑物材料由于减少了在钉合线处组织撕开的变化并减少了在脆弱组织卡钉拉出,从而为脆弱组织提供加强层。支撑物材料还形成了更强的钉合线,用于提高安全性,防止在外科手术和随后的关键性几个星期期间空气和/或流体渗漏和/或大量出血。
已经描述过各种材料用作钉合线支撑物材料,这些材料包括由特别处理组织(例如牛心包膜组织)、藻酸盐、聚乙二醇毡(polyglycolic felt)和特氟隆商标材料制成的材料,然而仅仅发现一少部分适合于商业用途。这些支撑物材料一般地以可释放方式安装在外科手术钉合机的工作面上,从而在触发后,病人组织夹在支撑物材料带条之间。
支撑物材料一般地通过机械和/或化学方法可释放安装在外科手术钉合机工作面上。在有些情况下,粘合剂涂敫于钉合机本身的一个或者两个表面上,或者涂敷于支撑物材料带条表面上,而该带条然后敷到对应的工作面上。例如,在直线钉合机的情况下,支撑物材料常常用粘合剂固定到每一并列的爪上。当前的粘合剂一般地是涂敷于支撑物材料本身的生物相容的凝胶,以使材料水合,并在材料和钉合机之间形成临时的粘合力。
在很多情况下,通常需要把支撑物材料正确地对齐和定位在钉合机工作面上。不正确地对齐支撑物材料常常导致失效的钉合线。包括对齐特征的设备已经被开发,来帮助使用者把支撑物材料正确地对齐在钉合机工作面上。例如,这样一种设备在申请人的第5,752,965号美国专利中描述,其中该专利文件整个内容在这里以参照方式引入。
发明内容
发明提供一种改进的支撑物材料。当前的把支撑物材料定位在钉合机工作面上的方法一般包括至少两个步骤,把粘合材料敷在支撑物材料上(或者敷到外科手术钉合机工作面上)的步骤和然后把该支撑物材料敷到工作面上的步骤。发明使把支撑物材料敷到钉合机工作面上的一个步骤方法成为可能。此外,即使利用对齐器械,当前的把支撑物材料对齐在钉合机工作面上的方法也不能经受失效考验。常常是,当使用者把粘合剂敷到支撑物材料或者钉合机工作面上时,要敷太多的粘合剂。这些过量粘合剂常常使工作面变得光滑,同时支撑物材料本身沿着表面滑动而变得未对齐。因此,发明还提供一种把支撑物材料敷到钉合机工作面上的方法,该方法显著地降低由于使用者对粘合剂使用不当而导致的未对齐。
附图说明
图1为示出了根据发明实施例的支撑物材料物件的透视图。
图2为示出了根据发明实施例的在外科手术钉合机和两个支撑物材料物件之间啮合的方法的透视图。
图3为根据发明实施例的对齐设备的局部分解图,其中该对齐设备适合于带有两个支撑物材料物件。
图3b为在图3a中的设备沿着直线SB的剖面图。
图4a示出了根据发明实施例的在外科手术钉合机和对齐设备之间啮合方法的透视图,其中该对齐设备带有两个支撑物材料。
图4b为在图4a中的设备沿着直线4B-4B的剖面图。
优选实施例的详细描述
在一些实施例中,发明提供具有至少一个粘合表面的缝合线支撑物材料,该材料以这样方式被包装和提供,即:允许表面与外科手术接合器工作面对齐并可释放地覆盖该工作面。术语“缝合线”在这里用来指任何一行缝合组织。缝合线可利用卡钉、卡箝等等缝合。此外,根据使用的外科手术接合器种类,缝合线可以是直线、圆弧、曲线或者任何其他合适形状或者图案。支撑物材料适合于与在本领域公知的任何外科手术接合器一起使用。在优选实施例中,优选的是,外科手术接合器包括外科手术钉合机,更优选的是包括直线钉合机。
支撑物材料常常以带条或者其他形状提供,其中至少有两个较大表面,一个表面适合于与外科手术接合器工作面接触,而另一个表面适合于抵靠身体组织定位。支撑物材料的粘合表面设置在将与外科手术接合器工作面接触的表面上。粘合剂此外还足够粘,以在外科手术接合器定位在外科手术部位期间,允许材料优选的是在没有例如可除去衬套、线或者增添凝胶情况下保持在外科手术接合器工作面上,然后在外科手术接合器应用时从工作面上去除。
具有至少一个粘合表面的支撑物材料具有若干优点,包括能够避免了用于施加粘合剂凝胶的单独步骤的需要。由于当前使用的两步装载过程此时变为一步装载过程,这样促进了把支撑物材料容易装载到外科手术接合器内。此外,第二步骤的去除有助于降低使用者对粘合剂的使用不当。
具有至少一个粘合表面的支撑物材料由单一材料组成,或者由两种或者更多相同或者不同材料的组合物组成。在优选实施例中,支撑物材料包括具有足够机械强度以加强缝合线的至少一种材料(在下文中称为“增强材料”)。该材料的组合件物可作为材料层、材料同质混合物、材料分级混合物或者其他合适形式提供。
增强材料还可以由合成或者天然组织形成,在某些实施例中,增强材料由天然动物组织形成,而在一些情况中,天然动物组织是纤维浆或者浆膜,在由优选情况中,天然动物组织为包括心包膜优选的是牛心包膜的纤维浆膜,在一些实施例中,天然动物组织可以是在申请人自己的第5,503,638号、第5,575,803号、第5,549,628号、第6,468,313号、第6,312,474号和第6,652,594号美国专利中描述的类型,其中这些专利文件中每个的全部内容在这里以参照方式引入。
在特别优选的情况中,增强材料包括可从申请人的受让人获得的处理过的牛心包膜,以Peri-Strips Dry商标销售。对这种特殊材料使用的优点在于,它与大多数其他关联组织相比,具有更高密度的胶原蛋白,并与戊二醛交联。牛心包膜的高密度使在缝合线周围的结构完整性提高,同时与戊二醛交联的优点在于,它降低了组织的抗原性,由此导致与邻接身体组织很少或者没有炎症反应,在发明的另一个优选实施例中,增强材料包括可从申请人的受让人获得的处理过的牛心包膜,以Veritas商标销售。尽管在本发明的优选实施例使用牛心包膜作为支撑物生物材料,然而容易理解的是,可以使用包括而不是局限于马、豪猪、绵羊和人的其他合适的心包膜或者硬脑脊膜以及生物亲合的合成材料。
在本发明的优选实施例中,增强材料包括平滑、稠密、无孔的薄膜。交联的牛心包膜组织,例如Peri-Strips Dry材料是这种稠密薄膜的实例。在其他的实施例中,增强材料抵抗或者大体上抵抗体内衰老。例如,优选的是,这种增强材料一旦与体液或者盐溶液接触几乎没有水解。例如Peri-Strips Dry材料的交联牛心包膜是抵抗体内衰老的材料的实例。在其它情况下,提供随着时间过去与身体组织周围融合的可再塑材料。优选的是,该材料包括非交联的动物组织,例如牛心包膜。Veritas材料是这种可再塑材料的实例。
在另外的实施例中,增强材料呈现优良的拉伸强度、防漏性能和抗破裂性能。例如,优选的是,材料具有预先植入拉伸强度,其中最大负载至少在2000克左右,更优选的是,至少在3000克左右以及最佳的是至少4000克左右。在其他情况中,该材料具有这样的预先植入拉伸强度,其中一旦植入体内,拉伸强度不随着时间而明显地减少。材料的预先植入拉伸强度可利用MTS Q45单轴拉伸测试机来测量。还优选的是,增强材料具有至少大约90毫米汞柱的渗漏压力,更优选的是至少大约150毫米汞柱的渗漏。在其他实施例中,增强材料具有至少大约90毫米汞柱的破裂压力,更优选的是,至少大约150毫米汞柱的破裂压力,最佳是至少大约200毫米汞柱的渗漏压力。渗漏压力和破裂压力的测量可通过把蓝色染料以恒定速率引入到缝合线一侧,然后施加压力。渗漏压力是观察到的穿过缝合线蓝色染料渗漏时的压力。当压力达到平稳时或者当缝合线破裂时突然降落时记录破裂压力。例如Peri-Strips Dry材料的交联牛心包膜是呈现优良拉伸强度、防漏性能和抗破裂性能材料的实例。
支撑物材料可以各种方式设置粘合表面。在一些实施例中,支撑物材料包括具有优良粘合剂性能的单一材料。该单一材料还优选的是具有足够的机械强度来加强缝合线。例如,水凝胶膜可作为该单一材料提供,其中水凝胶本身拥有足够的机械强度。在这种情况下,支撑物材料的任何表面可作为粘合表面提供来与外科手术接合器工作面接触。
在其他的实施例中,粘合剂预先施加在支撑物材料表面上(该支撑物材料可包括单一材料或者一种或者更多材料的组合件物)。在这些情况中,由于单独的粘合剂预先涂敷于表面上,因此组成支撑物材料的该一种或者更多材料通常具有增强和支持性能,而不是粘合剂性能。然而这决不需要,同时该一种或者更多材料可确定地包括具有粘合剂性能。在这种情况下,包含预先涂敷粘合剂的支撑物表面作为粘合剂表面提供。优选的是,粘合剂经由一层膜而形成在表面上,然而其他结构也是可能的。
根据利用传统涂覆设备和材料的本领域任何已知的方法,粘合剂可预先涂敷在支撑物材料的一个或多个表面上。例如,适当的涂覆方法包括气刀、刷、砑光机(calendar)、浇铸、遮蔽、浸涂、挤压、刮、用刮刀涂、凹版印刷、吻涂辊、刮刀上胶(knife over blanket)、刮刀过压(knife overroll)、间接凹版印刷、反向辊、反向光泽辊、棒、喷射、挤压辊、体内聚合和粉末树脂涂覆。而涂覆材料可以是任何适当形式,例如粉末树脂组合件物、含水溶剂或者格式溶剂(solvent based lattice)、乳浊液或者悬浊液的形式。
粘合剂可涂敷到支撑物材料的一个表面、两个或更多表面或者全部表面上。如果支撑物材料是多孔或者能够浸透,则该粘合剂可被施加以浸透整个支撑物。优选的是,水凝胶只涂覆到一侧,其中相对侧保持不涂覆,或者本身被处理或者带有适当的涂层或者性能。优选的是,粘合剂作为薄层敷在一个或多个表面上,该薄层例如在大约0.1毫米和大约1.0毫米标称厚度之间,更优选的是在大约0.25毫米和大约0.75毫米标称厚度之间。
各种材料可作为粘合剂提供。在优选实施例中,粘合剂包括生物相容凝胶。在特别优选实施例中,粘合剂包括还可以被称作聚合含水凝胶的水凝胶。适当的水凝胶包括基于天然水凝胶(例如人造丝、纤维素材料)以及例如甲基丙酸烯和丙烯酸酯等合成水凝胶的那些水凝胶、丙烯酰胺水凝胶、基于N-乙烯基-2-吡咯烷酮的水凝胶以及包括其掺合物、混合物和共聚物的聚电解质复合物和充电的水凝胶。发明人已经发现适当的水凝胶提供这种性能的最优组合件,这些性能例如为特别粘接到支撑物材料性、粘接到外科手术接合器工作面性、柔性、形式、生物适合性、生物稳定性以及被灭菌能力。
适当水凝胶的实例包括从位于新泽西州Branchburg的Hydromer公司得到的商标名称为Aquatrix IITM的那些水凝胶。在特别优选实施例中,水凝胶包括聚(N-乙烯基-内酰胺)-脱乙酰壳多糖(chitosan)凝胶。这种凝胶在第6,379,702号、第6,365,664号、第6,121,375号、第5,420,197号、第5,258,421号和第5,156,601号美国专利中描述过,其中这些专利文件中每一篇的全部内容均在这里以参照方式引入。脱乙酰壳多糖是一种脱乙酰甲壳质,并且是脱乙酰N-乙酰-D-葡糖胺的线性聚糖。在药品、某种膜和一些化妆品中,已经使用例如聚乙烯吡咯烷酮(PVP)的聚(N-乙烯基-内酰胺)。它们可用于提供具有亲水吸收剂性能的亲皮肤凝胶和小于60的K值。优选的是,这种材料是稳定、亲水的凝胶,其中在有或者没有增塑剂情况下,包括酸中和的脱乙酰壳多糖和聚(N-乙烯基内酰胺)、具有小于大约60K值的聚(N-乙烯基-内酰胺)和至少大约1.4酸根的摩尔当量。
这种优选的凝胶可通过把含水的聚(N-乙烯基-内酰胺)溶液和在水溶液中的酸中和的脱乙酰壳多糖混合而制备,其中以从大约12/1到大约1/1,优选的是从大约10/1到大约5/1的聚(N-乙烯基内酰胺)/脱乙酰壳多糖重量比混合,从而形成大约5重量%到40重量%优选的是从大约12.5重量%到大约25重量%总聚合物浓度的混合物,并让该混合物固化,直到形成凝胶。
在一些实施例中,粘合表面具有预定粘合强度或者粘性,当该粘合表面水合时该预定粘合强度降低。在这里使用的术语“粘性”和“粘合强度”用来描述粘合剂的附着性。粘合剂的粘性一般地为通过粘合剂完全地粘着到被拉来的两个表面上施加的抗拉性(用达因力来计量)。抗拉性越高,粘合剂粘性就越高。因此,当粘合材料在身体外部,并处于干燥形式时,它具有足够的粘性以阻止支撑物材料沿着外科手术接合器工作面除去或者重新对齐。然而,当该支撑物材料处于它与组织和体液接触的体内时,它被水合而导致表面容易从外科手术接合器工作面移开。因此,在优选情况中,粘合表面被包装并以具有足够粘性以牢固地敷在外科手术接合器工作面上的方式设置,当粘合表面位于外科手术部位内部时,此粘性降低。
在优选实施例中,本发明的粘合材料可用于把一个或多个生物活性剂输送到放置部位的局部或者更广泛地说系统地经过病人。这种生物活性剂可用来提高粘合剂本身的功能和/或它们可在体内起到相关或者无关的功能。在一个实施例中,例如,粘合剂本身可主要地作为生物活性剂输送装置,同时它起到辅助的支撑物材料的作用。在优选情况中,一个或多个生物活性剂设置成促进被钉合或者缝合组织的愈合。适当的愈合生物活性剂的实例包括然而不局限于抗生素、消炎药、生长素和细胞活素。还可以提供凝血剂来减少流血,同时还可提供放射性表面声波以监测体内支撑物材料的位置。
在一些实施例中,发明还提供外科手术组合件,包括根据已经描述的任何实施例的支撑物材料。例如,在一些情况中,提供包括外科手术接合器和至少一件支撑物材料的组合件。在本领域已知的任何外科手术接合器可用于这个组合件中。在优选实施例中,优选的是,外科手术接合器包括外科手术钉合机,更优选的是包括直线钉合机。在其它情况中,提供包括用于以支撑物材料装备外科手术紧固的设备和至少一件支撑物材料的组合件。用于以支撑物材料装备外科手术接合器的适当设备在以下专利文件中描述,即第5,752,965号和第6,656,193号美国专利以及第20040093029号、第20030120284号和第20020165563号美国公开文件,其中每篇文件的全部内容在这里以参照方式引入。这种设备对于把一件或多件支撑物材料布置成与外科手术接合器的工作面可释放固着是有用的,从而支撑物材料物件自动地与那些表面对齐。至少一件支撑物材料可设置成安装在支撑物材料内,或者作为外科手术套件一部分的单独部件,其中在外科手术部位,支撑物材料插入设备内。
在某些实施例中,发明提供利用支撑物材料的外科手术方法。发明的支撑物材料可用于各种外科手术中,这些外科手术包括血管、肥胖症、泌尿科、妇科、胸科和儿科外科手术。普通肥胖症外科手术包括胃旁通和胃折弯。胃旁通外科手术还包括以下种类外科手术:鲁氏Y型胃旁通(roux-en-y-gastric)(RYGB)、垂直带状胃成形术和胆胰(biliopancreatic)移植。普通胸外科手术包括小泡切除(blebectomies)、大泡切除(bullectomies)、楔形切除术、分段切除术、叶切除术、肺切除术、肺容量减少外科手术及其他肺和支气管切除术。
本发明的外科手术方法通常包括把一件或多件支撑物材料提供到外科手术接合器工作面上、把外科手术接合器围绕身体组织区段周围定位以及应用接合器以形成增强的缝合线。在当粘合材料在体内水合时失去粘合强度情况下,期望的是,把外科手术接合器围绕身体组织区段定位足够长时间,以使粘合材料水化,从而支撑物材料物件将容易从外科手术接合器工作面去除。
下面针对发明的优选实施例来描述本发明的支撑物材料的使用,其中优选实施例通过附图示出。图1示出了具有预先敷在增强材料108表面103上的具有粘合材料105层的支撑物材料100物件。该粘合材料105包括任何适当的粘合材料,而增强材料108包括任何适当的增强材料。该支撑物材料100的尺寸和结构设计成定位和对齐在直线钉合器爪上,同时表面103包含与爪表面直接接触的粘合剂105。
图2示出了具有卡钉盒体支撑爪48的普通直线外科手术钉合机46,以及从两个把手上伸出的砧座支撑爪50,而该砧座支撑爪依次包括活动部分52和固定部分54,其可枢轴旋转并在56处可拆卸地铰接到活动部分上。盒体支撑爪48设置在盒体主体上(未示出),其中该主体容纳多个卡钉,这些卡钉纵向成排布置到爪48上,当元件48和50处于闭合位置时,其中该爪48与通过爪50支撑的砧座(未示出)相对。两件支撑物材料100a和100b设置的尺寸和形状用于安装到外科手术器械46的部分52和54的工作面上。如示出的那样,物件100a定位成它的预先敷贴粘合材料105层向上取向,以便附着于盒体支撑爪48的工作面上。同样地,物件100b定位成它的预先敷贴粘合材料105层向下取向,以便附着于砧座支撑爪50的工作面上。
图3a-3b示出了用于用支撑物材料装备外科手术接合器的设备10。该设备适合于根据特别优选实施例把支撑物材料100a件和100b结合。在本实施例中,设备10设置成与直线钉合机一起使用。
同时参见图3a-3b,设备10包括对齐框架18和布置在内部的压力均衡元件20。对齐框架18可以任何方式设置,从而把支撑物材料的物件100a和100b可释放固定地保持在对齐框架18内,从而物件100a和100b将与直线钉合机的相对爪元件自动对齐。在示出的实施例中,对齐框架18包括大致平面的外罩部22、第一导沟24和第二导沟26。外罩部22包括布置在内部的接收区40。压力均衡元件20布置在接收区40内部,并优选的是,由可变形然而有弹性的基底制成,例如泡沫塑料、橡胶和/或具有类似性能的许多适当材料。通过提供这种压力的均匀分布,在围绕设备10封闭外科手术钉合机步骤期间,压力均衡元件20确保物件100a和100b将更容易地与相对的工作面的形状和轮廓吻合。压力均衡元件20的弹性的优点还在于,它用来在对齐框架18接收区40内可释放地偏压物件100a和100b。
第一导沟24和第二导沟26的尺寸设计成调节外科手术钉合机并列和对齐设备的工作面啮合。
物件100a和100b设计成能定位在接收区40内,以便大略地分别与第一和第二导沟24、26对应。当外科手术钉合机向下夹到设备10内时,导沟24、26将自动地把外科手术钉合机的并列爪引导成与每一支撑物材料100a和100b的粘合表面105接触。
下面参见图4a和4b,示出的设备10完全地能够与外科手术钉合机46一起使用。在此实施例中,提供了包括支撑物材料物件100a和100b和用于用支撑物材料装备外科手术接合器的设备10的组合件。此实施例的设备10包括对齐框架18、第一支撑物材料物件100a和第二支撑物材料物件100b。物件100a和100b可释放地位于接收区40内,以便大略地分别与第一和第二导沟24、26与对齐。
为了使外科手术钉合机产生增强钉合线,使外科手术钉合机的并列工作面分别位于第一和第二导沟24、26内,并向下夹入到与物件100a和100b的粘合层105接触的位置。外科手术钉合机维持在此闭合位置一段给定时间,然后从该对齐框架18拉出,以除去压力均衡装置20,同时从接收区40内把支撑物材料100a和100b物件除去。粘合层105在物件100a和100b与外科手术钉合机的并列工作面之间形成足够的粘合力,从而当外科手术钉合机从先前夹紧定位打开时,物件100a和100b保持可释放地附着于外科手术钉合机的并列工作面上,而压力均衡元件20可从物品100a和100b之间移开。根据本发明,使用配备有物件100a和100b的外科手术钉合机,从而其相对的工作面可定位在身体组织区段周围,以形成增强钉合线。
尽管描述了本发明的,然而应该理解的是,在本脱离发明精神和附加权利要求范围情况下可进行各种变化、修改和改型。
Claims (29)
1.一种具有粘合表面的外科手术接合器支撑物材料,该材料以这样方式被包装和提供,即允许粘合表面与外科手术接合器工作面对齐并可释放地覆盖该工作面。
2.根据权利要求1的材料,该材料以这样方式被包装和提供,即允许在单一步骤加载过程中,粘合表面与外科手术接合器工作面对齐并可释放地覆盖该工作面。
3.根据权利要求1的材料,其中粘合表面具有足够粘合强度,以在外科手术接合器定位在外科手术部位内过程中,在没有外部装置情况下,允许该材料保持在外科手术接合器工作面上,然后在外科手术接合器应用时从工作面上去除。
4.根据权利要求1的材料,其中粘合表面在保持在外科手术接合器工作面上时具有预定粘合强度,在粘合表面定位在体内并水合时,该粘合强度降低。
5.根据权利要求1的材料,其中该粘合表面是包括预先敷贴粘合材料的表面。
6.根据权利要求6的材料,其中该预先敷贴粘合材料包括预先敷贴水凝胶。
7.根据权利要求6的材料,其中该预先敷贴粘合材料还包括一种或多种生物活性剂。
8.根据权利要求1的材料,其中支撑物材料包括具有足够机械强度以加强缝合线的至少一种增强材料。
9.根据权利要求8的材料,其中支撑物材料包括两种或者更多材料的组合件物,其中至少一种材料为增强材料。
10.根据权利要求8的材料,其中该至少一种增强材料在埋入体内时显著地抵抗老化。
11.根据权利要求8的材料,其中该至少一种增强材料具有预先植入的拉伸强度,该拉伸强度具有至少大约2000克的峰值负载。
12.根据权利要求8的材料,其中该至少一种增强材料具有预先植入拉伸强度,其中当埋入体内时,该拉伸强度随着时间不显著地降低。
13.根据权利要求8的材料,其中该至少一种增强材料具有至少大约90毫米汞柱的渗漏压力或者破裂压力。
14.根据权利要求8的材料,其中该至少一种增强材料包括天然的动物组织。
15.根据权利要求14的材料,其中该天然的动物组织包括纤维浆或者浆膜。
16.根据权利要求15的材料,其中该天然的动物组织包括具有牛心包膜的纤维浆膜。
17.根据权利要求8的材料,其中该至少一种增强材料还具有足够粘合强度,以在外科手术接合器定位在外科手术部位内过程中,在没有外部装置情况下,允许该材料保持在外科手术接合器工作面上,然后在外科手术接合器应用时,将材料从工作面上移除。
18.一种组合件,包括具有至少一个工作面的外科手术接合器和根据权利要求1的位于该至少一个工作面上的支撑物材料。
19.如权利要求18的组合件,其中该外科手术接合器包括外科手术钉合机。
20.一种用于便于支撑物材料对齐和敷贴在外科手术接合器工作面上的设备,该器械含有根据权利要求1的支撑物材料。
21.根据权利要求20的设备,还包括对齐框架,该对齐框架把一个或多个支撑物材料物件保持与该对齐框架可释放地固定,从而该一个或者更多物件将自动地与外科手术接合器并列工作面对齐。
22.一种用于便于支撑物材料物件敷贴到外科手术接合器并列工作面上的外科手术套件,该套件包括根据权利要求1的一个或者更多支撑物材料物件和对齐设备。
23.根据权利要求22的外科手术套件,其中该一个或者更多支撑物材料适合于载入到对齐设备。
24.一种外科手术方法,包括的步骤为:
提供根据权利要求1的一个或多个支撑物材料物件;
把一个或者更多支撑物材料物件敷到外科手术接合器工作面上;
把外科手术接合器定位在身体组织区段周围;
以及夹紧接合器以形成增强缝合线。
25.如权利要求24的外科手术方法,其中定位外科手术接合器的步骤包括:把外科手术接合器定位在身体组织区段周围足够长的一段时间,以使该粘合表面水化。
26.如权利要求24的外科手术方法,其中应用接合器的步骤包括一旦粘合表面已经水合,则夹紧接合器。
27.如权利要求24的外科手术方法,其中该方法适合于用在从以下组中选择的外科手术中:血管、肥胖症、泌尿科、妇科、胸科和儿科外科手术。
28.如权利要求27的外科手术方法,其中方法适合于用在从以下组中选择的肥胖症外科手术中:鲁氏Y型胃旁通、垂直带状胃成形术和胆胰移植组成。
29.如权利要求27的外科手术方法,其中该方法适合于用在从以下小组中选择的胸外科手术中,该小组由小泡切除术、大泡切除术、楔形切除术、分段切除术、叶切除术、肺切除术、肺容量减少外科手术及其他肺和支气管切除术。
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Also Published As
Publication number | Publication date |
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JP5173439B2 (ja) | 2013-04-03 |
JP2008528203A (ja) | 2008-07-31 |
BRPI0606896A2 (pt) | 2009-07-21 |
JP2012106026A (ja) | 2012-06-07 |
ATE529050T1 (de) | 2011-11-15 |
BRPI0606896B1 (pt) | 2020-10-27 |
WO2006083748A1 (en) | 2006-08-10 |
EP1848346B1 (en) | 2011-10-19 |
US20060173470A1 (en) | 2006-08-03 |
ES2375975T3 (es) | 2012-03-07 |
US20120197272A1 (en) | 2012-08-02 |
AU2006211147B2 (en) | 2012-07-19 |
CA2596254A1 (en) | 2006-08-10 |
US20100234861A1 (en) | 2010-09-16 |
EP1848346A1 (en) | 2007-10-31 |
CA2596254C (en) | 2014-01-07 |
BRPI0606896B8 (pt) | 2021-06-22 |
MX2007009179A (es) | 2007-09-21 |
AU2006211147A1 (en) | 2006-08-10 |
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