CN100502794C - 输送治疗流体的缝合线 - Google Patents
输送治疗流体的缝合线 Download PDFInfo
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- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06166—Sutures
- A61B2017/06185—Sutures hollow or tubular
Abstract
提出了一种可输送治疗流体到伤口周围组织和可以缝合伤口的活性缝合线。本发明能够输送有效体积药物的溶液,并提供高水平的流体输送速率控制。
Description
相关申请
本发明申请是2003年12月4日提交的美国专利申请No.10/727,367的部分继续申请。
技术领域
本发明涉及一种机构,可用于输送治疗流体到外科创伤。具体地,本发明涉及一种功能性缝合线,可用于输送治疗或生物活性流体到伤口周围的组织。更具体地,本发明涉及一种编织缝线,具有内部通道,能够沿至少部分长度的缝线输送流体,缝线可通过连接件连接到流体源的一端。
背景技术
输送治疗流体到外科创伤的附近具有许多好处。减少疼痛,加速伤口痊愈,和减少手术部位的感染只是几个能够带来的好处。但是,成本效益高的可长时间局部直接输送治疗流体到伤口部位的机构的形式和功能仍未见到。向手术后的病人进行静脉输送药物(IV)是通常采用的方法。外科医生使用IV长时间地直接输送各种药物到病人血液。静脉给药是输送药物的系统方法,其中药物在整个身体内循环,然后部分药物输送到伤口位置。由于许多药物在到达伤口位置之前在身体内其他位置产生代谢变化,因此有必要增加通过IV系统输送的药物的总量或浓度,以便有效数量的药物到达伤口位置。但是,在许多情况下,增加药物的浓度可对伤口产生最佳的效果,但是不能通过IV安全输送,因为体内各种器官可能发生毒副作用。其他药物,如某些局部麻醉剂,只有局部输送才能提供灵验的效果,不能简单地采用IV输送方法进行输送。
在手术前、期间或之后对外科伤口或其附近多重注射用于减少手术产生的副作用和并发症。尽管注射器和皮下注射针提供了局部药物输送方式。但长时间通过注射连续输送药物是不实际的。事实上,随着时间推移药物扩散成为低于实现治疗作用所要求的浓度,必须进行另外的注射。此外,在手术创伤只是药物处理的局部目标的情况下,可要求进行围绕伤口处的多重注射,以达到希望的治疗作用。这样,如果多重注射必须重复进行时,病人可感到不舒服和受到重复打扰。这个方法的另一个缺点是,健康护理人员必须贡献其宝贵的时间和注意力,重复进行局部注射。
为了解决上面提到的局部和连续输送治疗流体的IV和注射的缺点,许多专用用于伤口位置的传输导管已经开发出。这些专用的传输导管通常显示出沿其长度设有许多孔,并连接到容纳和输送治疗液体到传输导管的容器和泵,如美国专利5,458,582,5,891,101,和6,626,885所介绍的。传输导管本身可直接设置到外科伤口和通过围绕伤口缝合伤口而保持在适当位置。但是,这种应用方法可带来很大的感染和危及伤口愈合的危险,因为传输导管作为了病菌进入外科伤口的通道。更常见的是,传输导管穿过伤口附近的皮肤和皮下组织,保留传输导管的顶尖于外科伤口,导管主体于伤口周围的健康组织。重要的一点是,以这种方式植入传输导管一般要求使用套管刺入和引导传输导管通过皮肤和皮下组织,进入外科伤口位置。尽管这些导管提供了连续输送治疗流体到伤口的方法,但存在许多缺点。许多机构,如美国专利6,626,885所介绍的,要求使用套管和在外科伤口附近另外刺入伤口,以牢固地固定导管于适当位置,尽管美国专利5,891,101和美国专利5,458,582要求使用另外的缝合线或改进的缝合程序。即使这样,传输导管仍不能牢固地固定,经常会被病人从伤口处不经意地拔出。或者,为了减少病人的与取出导管相关的不舒服感和其他并发症,某些导管机构,如美国专利5,458,582所介绍的,可用生物吸收材料制造。但是,植入生物吸收导管增加了身体必须吸收和代谢的材料数量,通常希望这种生物负担最小。最后,使用这些专用导管和支承容器、这种操作专用泵还大大增加了成本,从数百美元增加到数千美元。
可局部和连续地输送药物的缝合线可满足前面提到机构的未能满足的需要。缝合线植入伤口周围的组织中,在这个区域有益于局部药物输送。此外,因为在大部分情况下必须有缝合线来实现伤口缝合,病人必须承受的刺入程序的数量不必增加。此外,连接到缝合线一端的缝合针可用来穿透伤口周围的组织,帮助设置流体传输缝线。缝线可通过在一端打结固定到伤口处,防止不经意拉出。此外缝线具有的柔韧性要比传输导管具有的柔韧性大许多,从而缝线可以复杂图案设置,或设置在传统传输导管难以到达的位置。尽管药物传输用缝合线可带来许多好处,但这样的机构的形式和功能不很清楚。
美国专利3,918,455首次公开了中空单根缝合线的概念。尽管该专利的内容主要是使用中空缝合线,以便连接到缝合线针。还提出建议,安装时中空缝合线的孔可用流体填充,加快缝合线材料的分解或使得缝合线可被X光射线发现。还建议可挤出和拉伸出管子,使其转变成多孔状态。在这样的状态下,中空缝合线的壁的聚合物允许缝合线的孔中含有的流体逐渐通过壁扩散到周围组织。美国专利5,984,933介绍了一种缝合组织的机构。尽管该专利主要涉及内窥镜缝合的方法和装置,其建议装置的缝合线材料可以是实心或中空的,当缝合线的材料是中空时,缝合线的壁上可形成小孔,使得容纳于缝合线孔中的药物溶出进入周围组织。尽管这些专利建议中空缝合线可用来容纳,在某些实施例中可缓慢发散出,治疗流体,但仍有某些重大缺点尚未克服。首先,单根缝合线具破裂敏感性。在中空缝合线的壁上设置孔或小孔可导致缝合线强度性能的明显下降,并导致不能可靠地缝合伤口。其次,可容纳于中空缝合线内的药物数量很少。实际上容纳于中空缝合线的最大药物溶液数量在0.005毫升或更小的量级,而许多可买到的药物溶液只有数量超过1毫升时才有效。例如,麻醉剂如麻卡因,利多卡因,丁呱卡因,嘧哌凡卡因和普鲁卡因,一般以缓冲溶液注射到创伤或伤口附近的组织,总体积在5到30毫升的范围,是美国专利3,918,455和美国专利5,984,933公开的中空缝合线可施加剂量的500到3000倍。最后,一旦中空缝合线植入到伤口附近的组织,药物传输速率用流体渗入或扩散通过多个小孔或孔的速率表示。不可能实现主动控制药物传输速率和连续药物传输。另外,如果对药物的反作用发生,缝合线必须在伤口处切断,终止药物输送。
美国专利4,159,720公开了一种传输液体到组织的方法。优选实施例包括容纳流体的容器,容器连接到主体的外侧,可输送液体到吸收芯。吸收芯采用通常用来制造缝合线的材料制造,可通过各种方式安装到组织内,包括设置在伤口内侧或布置在伤口周围的组织内。该发明依靠毛细管作用将流体吸入并控制传输速率。这样,流体传输速率不由医生随意决定是增加或减少。此外,流体流入速率取决于芯部材料的类型和安装的芯部的厚度和长度。应当重点指出的是,在缝合线包括不能被流体润湿材料或涂复了不能被流体润湿材料的情况下,芯吸作用将不发生,该装置不能工作。即使在输送的流体不能润湿芯部的情况下,可期望相关于缝合线的毛细管力驱动的流体输送速率要比通过其他方式如IV,传输导管,或注射,实现的流体传输速率慢数个量级或等级。
希望有这样一种缝合线,可具有伤口缝合和药物输送的多种功能。但是,不同于前面提到的现有技术的示例,缝合线应当1)不危害关键性能,如缝合线的强度,2)能够输送有效数量的药物溶液,以毫升的量级而不是微升的量级,3)提供高水平的药物输送速率控制,并使得外科医生可根据其判断开始或停止送药,4)具有可提供不止一种类型药物的各种方式,药物可根据可能出现的未预料到的病人症状在术后选择,5)功能与缝合线材料的成分和润湿性无关。
本文公开了一种满足前面提到的伤口缝合和药物输送要求的缝合线。需要着重指出的是,尽管本文公开的机构以多功能方式用于缝合伤口和输入流体到伤口位置,缝合线主要用作传输机构的更简单应用同样可以和有效。缝合线的部件可包括连接件,其设计成可连接流体容器,如IV,注射器,或扩散泵,到编织缝合线,缝合线容纳至少一个内部通道,能够沿至少一部分长度传输流体。治疗流体从容器通过连接件到达内部通道,和多根编织缝合线之间的空隙。这样的装置设计不会危害编织缝合线的整体性,关键性能,如缝合线强度,保持超过美国药典,美国专利USP,及标准。通过使用连接件来连接缝合线的流体传输件到外部容器,通过缝合线输送的治疗流体的数量可增加到有效治疗的体积。此外,通过调节治疗流体的供应可主动控制药物传输速率,可根据需要提供不止一种类型的药物。
发明内容
本文介绍了一种活性缝合线,其包括编织缝线,具有近端、远端及外径;至少一个通道,与至少一部分编织缝线同轴,具有近端、远端及直径,所述直径小于所述编织缝线的外径;其中,至少一个通道的远端设置在编织缝线的近端和远端之间。
还介绍了一种活性缝合线,包括:具有外径的编织缝线,和管路,与至少一部分编织缝线同轴,具有外径和内径,外径小于所述编织缝线的外径,其中设有一个或多个开口;管路外径与内径的比大于1.7。
还介绍了一种活性缝合线,包括具有外径的第一编织缝线,具有嵌入其中的涂复纤维束或涂复编织缝线,与至少一部分第一编织缝线同轴,所述涂复纤维束或涂复编织缝线的外径小于第一编织缝线的外径,所述涂复纤维束或涂复编织缝线具有一个或多个开口。
还提出了一种控制流向伤口的流体的方法,伤口已经用编织缝线缝合,编织缝线具有近端、远端及外径;至少一个通道与至少一部分编织缝线同轴;所述通道具有近端、远端和位于远端的开口,小于编织缝线外径的直径,所述至少一个通道的远端位于编织缝线的近端和远端之间;使得至少一个通道的远端位于伤口或伤口附近。
还提出一种使用缝合线/针组件缝合伤口的方法,可选择与控制流向伤口的流体方法结合,组件包括编织缝合线,具有近端和远端及外径,至少一个通道,与至少一部分编织缝合线同轴;所述通道具有近端和远端,位于远端的开口及直径,其小于编织缝线的外径;其中至少一个通道的远端设置在编织缝线的近端和远端之间,连接到编织缝线远端的手术针;连接到所述至少一个通道近端的连接件。
附图说明
图1a,1b是活性缝合线的示意图;
图2a是沿图1a或1b的剖面2-2的示意截面图,显示了芯部的微管;
图2b是沿图1a或1b的剖面2-2的示意截面图,显示了芯部的微小孔,带有沿微管长度延伸的裂口;
图3a是沿图1a或1b的剖面2-2的示意截面图,显示了芯部的涂复纤维束;
图3b是显示涂复纤维束的示意截面图;
图4a,4b,4c,4d和4e分别是各个活性缝合线的实施例的流体发散部分的截面图;
图5a,5b和5c示意性显示了连续采用的步骤,显示作为简单流体传输机构的活性缝合线;
图6a,6b,6c和6d示意性显示了连续采用的步骤,显示用于伤口缝合和流体传输的活性缝合线;
图7a,7b示意性显示了活性缝合线的双臂实施例;
图8a,8b示意性显示了双臂的活性缝合线,用于断开的垫式缝合图案;
图9是在两个不同流体压力下的相对内部通道长度和直径的流体传输速率的图表;
图10a,10b和10c是显示活性缝合线的随时间分配流体的一系列图像。
具体实施方式
本发明公开了一种活性缝合线,可以连续或不连续的方式长时间输送一种或多种治疗流体到伤口附近,无须其他刺入机构或程序,基本上不增加被身体代谢的材料数量,不必投资昂贵的装置或设备。将活性缝合线插入组织不必使用传统传输导管所用的套管和准绳。
图1示意性显示的活性缝合线10包括编织缝线14,其具有一个或多个内部通道12,能够在至少一部分编织缝线中传输和排出治疗流体。活性缝合线的远端可连接到缝合针16。位于至少一部分缝合线的内部通道可从缝合线延伸,连接件18可安装到所述通道的近端,使流体在外部流体容器和活性缝合线的内部通道12之间连通。连接件18可设计成直接连接各种常用的流体容器,包括但不限于,注射器,或连接到静脉传输系统或不同的流体传输泵的传统医用管路,如美国专利6,626,392,6,626,855,5,284,481和5,080,652所介绍的。如美国专利6,626,392和6,626,855公开的,一种用弹性聚合物生产的可膨胀的容器34串连接到连接件18和注射器接头20之间。注射器可连接到注射器接头20,用于膨胀容器。各种可买到的连接件包括但不限于:luer快速接头,单向阀,双向阀和T形接头。只能连接活性缝合线到特定容器,注射器或流体源的专用连接件可用来代替商业途径购买的连接件。美国专利6,626,855介绍的其他过滤流体或限制或阻挡流体的附件可整体形成于流体源。其他测量流速的机构,如美国专利6,371,937所介绍的,可结合到管路中,用于连接传输泵到活性缝合线。流体可从外部流体源通过连接件和内部通道传输,离开编织缝线的内部空隙,在伤口缝合手术前,期间或之后,进入缝合线周围的组织。施加的或由外部流体源具有的压力可超过编织缝合线内因毛细管或扩散现象产生的压力。此外,通过控制施加的压力或外部流体源具有的压力,可调节供应的流体,流体输送速率得到主动控制。
或者,如图1b所示,活性缝合线10的远端可连接到缝合针16,连接件18可安装到内部通道12的近端,使外部流体容器和活性缝合线的内部通道12流体连通。连接件18可设计成直接容纳各种传统的流体容器,包括但不限于注射器、流体泵或静脉输送系统。如图1b所示,连接件可装在内部通道和机构的编织缝线的周围。
活性缝合线的关键部分是内部通道,用于传导流体到编织缝线的内部空隙。沿图1a或1b的剖面2-2的含有内部通道的编织缝线的横截面图在图2a,2b,3a,3b示意地显示。如图2a所示,结合到编织缝线14的聚合物管路24的内腔12可用作内部通道。如图2b所示,管路24可容纳沿其整个长度的空隙或小裂口15,用作流体进入编织缝线14的通道。结合到编织缝线的用作内部通道的管路可具有各种截面形状,包括但不限于,圆形,矩形和三角形。类似地,传输流体内腔可采取各种形状,包括圆形,矩形和三角形以及五角星形状。或者如图3a,3b所示,涂复了连续聚合物外壳28的纤维束26或编织缝线,或被聚合物管路包围并同轴嵌入编织缝线14,各纤维之间空隙可用作内部通道。如图3b所示,聚合物涂复的纤维束或聚合物涂复的编织缝线,还可用作沿流体传输缝线的支承。
图4a所示的一部分活性缝合线的纵向截面图中,内部通道12可终止于编织缝线14内的连接件和缝合针之间。在这个实施例中,流体通过图1的连接件18进入,从活性缝合线的近端内流到图4a的位置43,继续流过内部通道12,从通道46的开口端离开,进入编织缝线14的内部空隙。在编织缝线14的内部空隙内累积的流体最终到达表面42,可渗透进入周围的组织14。在另一可选实施例中,流体可从沿内部通道长度的多个位置扩散。如图4b的纵向截面图所示,内部通道12容纳来自位置43的流体,流体通过一个或多个沿通道长度的开口48以及通过通道46的截端进入编织缝线。通道的开口实际上可具有任何的几何形状,包括但不限于,圆形,椭圆形和矩形。开口还可具有不同尺寸,或在某个位置比另外位置聚集的更紧密,实现沿缝线的不同位置有不同的流体传输速率。在另一实施例中,具有至少一个开口48的内部通道可沿活性缝合线的整个长度延伸,从缝线的近端到达缝合针。如图4c所示的部分活性缝合线的纵向截面图所示,进入位置43的流体可从沿活性缝合线的长度的一个或多个开口48发散。对于图4b所示的实施例,可假定开口有不同的几何形状,可沿缝线的长度通过各种方式进行分配。内部通道的连续开口,如图4d示意性所示的通道41,可帮助流体从内部通道发散到编织缝合线和伤口处。通道可沿直线设置,例如沿管路长度,或沿管路长度螺旋设置。在这个实施例中,流体可沿活性缝合线的长度在任何位置排出。最后,被沿部分长度的管路或聚合物涂层包围的编织缝合线,如图4e的纵向截面图示意性显示,可用于传输流体从图1a,1b所示的连接件18到达编织缝合线。需要重点指出的是,可以生产结合了流体传输件的活性缝合线。例如,桥接了连接件18和编织缝合线近端之间空间的流体传输件,如图1a所示,可以是微管。该微管然后可安装和固定到稍大管路内,管路嵌入编织缝线内侧,显示出沿长度的多个孔或通道,形成活性缝合线的内部通道。
活性缝合线可通过各种方式传输治疗流体。以最简单的方式,活性缝合线用于传输治疗流体到伤口处,不用作缝合伤口的机构。图5a,5b和5c示意性地显示了活性缝合线10用作流体传输机构的连续步骤。缝合针16刺入伤口附近的皮肤17和皮下组织,并继续进入到切口位置21,如图5a所示。然后活性缝合线通过缝合针16形成的孔,位于切口内,如图5b所示。在这个阶段,部分的内部通道12和连接件18仍处于体外。一个结或一系列结23可系在活性缝合线的近端,将缝合线固定在适当位置,防止不经意拉出,如图5b所示。包括缝合针25的多余缝合线剪断扔掉。切口21然后用传统的方式用另外的缝合线,U形钉或皮肤粘接剂缝合。在图5c所示的最后步骤,通过注射器22或容器的泵29提供治疗流体到活性缝合线。
或者,活性缝合线可用作伤口缝合线和流体传输机构。图6a,6b,6c和6d示意性显示了连续的步骤,显示出图1a所示类型的活性缝合线10用作缝合伤口缝线和流体传输机构。第一步,一系列结23越过伤口栓在活性缝合线的内部通道12远端和缝合针16之间位置。该步骤将缝合线分成两部分,一部分用于伤口缝合33,一部分用于流体传输31。缝合线的位于结和缝合针33之间部分用于继续缝合35拉近组织,如图6b所示。缝合线31的传输部分然后置于缝合路线35,如图6c所示。或者,在图6b所示的伤口缝合步骤期间,传输部分31固定到一个或多个连续缝合路线的下面。切口然后通过传统方式使用另外的缝合线,U形钉和/或皮肤粘接剂缝合。在图6d所示的最后步骤,通过注射器23或容器的泵29提供治疗流体到活性缝合线。
作为上面介绍的方法的替代方式,可取代将活性缝合线植入切口位置,而将活性缝合线植入切口周围的组织。可在手术前,期间或之后使用图1a,1b的缝合针16刺入皮肤进行植入。还可以选择,活性缝合线以传输治疗流体的方式植入任何组织,不管位置或操作程序,只要其未使周围组织受到不适当的创伤。
需要重点指出的是,除了如前面所示的在缝合伤口后输送治疗流体到伤口的方法,输送治疗流体可在使用活性缝合线的手术期间同时进行。在某些情况下,希望在使用缝合线之前,预加载或用治疗流体浸湿活性缝合线。另外的变化涉及手术前或手术期间输送一种治疗流体,然后是手术后输送另一种治疗流体。
还可以双臂缝合线的形式来实施本发明,如图7a和7b示意性显示,其中使用了两个缝合针16和一个连接件。在这些实施例中,连接件18设计成可容纳来自外部流体容器的流体,连接件通过与活性缝合线的内部通道12流体连通的方式,可连接到从活性缝合线的中部延伸的管路,如图7a所示,或连接到活性缝合线10,如图7b所示。双臂式缝合线还可采用各种方式。图8a和图8b示意性显示了用于断开的水平垫式缝合的双臂式缝合线10。
在容器泵或其他连续流体输送机构连接到活性缝合线的情况下,流体从活性缝合线发散的速率主要受到三个因素的控制:流体粘度,施加的压力和通道设计。流过圆柱形管路流体的Hagen-Poiseuille关系式可用于估计流过具有图2a和4a所示通道的活性缝合线的流体的体积流速。
体积流速=(π×施加压力×半径)/(8×流体粘度×通道长度)
其中,施加压力是流体源施加的压力。半径是流体通过的内部通道的有效半径,通道长度是内部通道从连接件到通道开口位置的有效长度。如果利用静脉传输,施加压力可由伤口上方的静脉给药高度决定。其中:
施加压力=流体密度×重力常数×病人上方的静脉给药高度。例如,如果静脉给药袋保持在伤口上方大约1米的位置,大约为0.1大气压(atm)的施加压力驱动流体流过活性缝合线。如果使用图1a的弹性的可膨胀容器34的话,驱动流体通过活性缝合线的施加压力可高达1个大气压。最后,一般连接到静脉输送系统的流体泵是可调的,可以不同的压力和速率传输流体到活性缝合线。在图9,Hagen-Poiseuille关系式用于估计在标准温度和压力(STP)下通过活性缝合线的水的体积流速,缝合线含有管状内部通道,类似于图1a,2a,和4a所示的实施例,内腔的内径为50,75和100微米,其终止于编织缝合线内,距连接件的距离小于0.2米。图9的实线表示0.1个大气压的施加压力能达到的输送速率范围。弹性的容器泵一般可提供0.1到1个大气压量级的压力。图9的虚线表示大约1个大气压的施加压力可达到的输送速率范围。内部通道的内腔直径和长度强烈影响到流体流动速率,较小直径的内腔和较长通道可导致输送速率降低。应当重点指出,图9提供了具有结的情况下药物输送速率的估计。缝合线的结产生了曲折路径的内部通道,并导致缓慢的输送速率。
在某些应用场合,希望在活性缝合线上打结,帮助伤口闭合。在许多情况下,伤口闭合程序,如图6a,6b,6c和6d所示的连续步骤,可减少对含有内部通道的活性缝合线的一部分打结的需要。通过这种方式,可用作伤口闭合的缝线和传输治疗流体的机构不会对流体输送速率的控制有反面影响。但是,如果采用的程序要求在含有内部通道的一部分活性缝合线上打结,内部通道必须保持完整,以便活性缝合线传输流体通过打结的位置。如果涂复纤维束或涂复编织缝合线的空隙用作活性缝合线的内部通道,如图3a和3b示意性显示,其中的空隙将可保持完整。但是如果使用微管来代替涂复纤维束,或涂复编织缝合线,来形成内部通道,可在打结处形成内腔破坏或封闭。为了防止内腔封闭,必须采用带有足够壁厚的管路。影响结内内腔破坏可能性的参数包括编织缝合线的厚度,缝合线中设有内部通道;管路的刚性,管路的强度,和形成结所施加的总张力。对于具有手术可接受的结,如平结或外科结,的活性缝合线,最好管外径与内径的比大于1.7,对于目前用于缝合线的大部分聚合物,材料外径和内径比大于2.0更好。
活性缝合线可通过下面的步骤制造,包括:生产用作活性缝合线的内部通道的流体传输件;将流体传输件结合到编织缝线,形成活性缝合线;连接流体传输件或活性缝合线的近端到连接件;并连接活性缝合线的远端到缝合针。尺寸和形式可与图1a,1b所示活性缝合线兼容的微管使用传统的聚合物挤出技术生产。管可直接挤出到适合的尺寸,或挤出到大于优选尺寸,然后通过传统的纤维拉伸技术减小尺寸。如果选择涂复纤维束或涂复编织缝线用作活性缝合线的流体传输件,如图3a,3b所示,生产的第一步涉及用连续聚合物外壳涂复编织缝线或纤维束的工艺。聚合物挤出机可采用模具,允许纤维束或编织缝合线通过,当纤维束或编织缝合线通过模具时被塑料膜密封。该工艺类似于用绝缘聚合物涂复金属丝的涂复工艺,已成为现有技术。管路,涂复纤维束或涂复编织缝线可继续加工,形成孔或通道,如图4b,c和d所示。流体传输件的这些开口可用机械方法形成,或用精密的激光加工设备制造。应当着重指出,在多个实施例中,沿流体传输件长度形成许多孔的步骤是可选择的。实际上,图4a所示实施例可简单地允许流体通过通道截端发散,不要求沿流体传输件的长度形成孔。一旦管路,涂复纤维束或涂复编织缝线已经形成,可与其他纤维束编织到一起,形成图4a,4b,4c或4d的活性缝合线。可通过使管路,涂复纤维束或涂复编织缝线连同编织缝线的芯线进行加工,使得编织缝线的编织线包围管路、涂复纤维束或涂复编织缝线。还可采用的另外的编织方法,包括使管路,涂复纤维束或涂复编织缝线绕编织缝线的芯线编织。编织后,图4a和4b所示的实施例可通过取下一部分管路或涂复纤维束或涂复编织缝线来形成。还可用精确的针夹持器夹持管路、涂复纤维束或涂复编织缝线,并拉夹持器通过编织缝线,直到一部分的管路,涂复纤维束或涂复编织缝线保留在编织缝线的内部,形成活性缝合线。或者,外径比编织缝线外径小的聚合物管可压接到编织缝线的近端。通过这种方式,部分管路,最多数厘米,可同轴位于编织缝线的内部,如图4a所示。同时相同管的一部分从编织缝线的近端延伸,如图1a所示。为了防止管路从编织缝线滑出,可施加少量的粘接剂于编织缝线的近端,以便将管路连接到编织缝线的多个纤维丝。还可采用另外的连接管路到编织缝线近端的方法,涉及热接或使用收缩聚合物套管。
活性缝合线的元件可用生物吸收和非吸收材料制造。缝线,管路,涂复纤维束,涂复编织缝线,粘接剂和本发明的连接件可用聚合物制造,这些聚合物通常用于制造缝合线,包括但不限于,聚丙烯、聚乙烯,聚酰胺,聚乙二醇对苯二甲酸酯,聚四氟乙烯,丝绸,聚已酸丙酯,聚二氧已烷酮,聚乙交酯,聚交酯,或聚已酸丙酯,聚二氧已烷酮,聚乙交酯,聚交酯的混合物。此外,由于连接件不必植入病人身体内,可从更多的工程聚合物中选择,其包括但不限于,无溶剂的聚氯乙烯,聚亚安酯,聚酯,聚碳酸酯,聚烯烃和聚酰胺。
可与上面介绍的缝线一起使用的流体包括治疗或生物活性制剂或流体,包括但不限于,抗菌剂或抗生素,如2,4,4`-三氯-2`羟基二苯基醚,杀藻胺,磺胺嘧啶银,聚乙烯吡酮碘,三氯生,庆大霉素;抗炎剂,甾族的或非甾族的,如塞来考昔,罗非考昔,阿司匹林,水杨酸,acetominophen,吲哚美辛,苏灵大,甲苯酰吡酸,酮咯酸,甲芬那酸,异丁苯丙酸,纳普罗森,苯基丁氮酮,苯磺唑酮,炎爽痛,吡罗昔康;麻醉剂,如通路阻断剂,麻卡因,利多卡因,丁呱卡因,马比佛卡因,普鲁卡因,氯普鲁卡因,罗哌卡因,邦妥卡因,丙胺卡因,左布比卡因,及局部麻醉剂与肾上腺素组合;鸦片止痛药,如吗啡,芬酞尼,可待因;抗增生药,如雷帕霉素;增长因子,如PDGF;富氧液体,用于伤口处理;伤疤处理剂,如hylauronic acid,血管生成促进剂,促凝结因子,抗凝结因子,趋化剂,促细胞凋亡剂,免疫调节剂,有丝分裂剂,苯海拉明,氯苯吡胺,吡拉明,普鲁米近,美其敏,特非那定,阿司咪唑,非索非那定,氯雷他定,硫代葡萄糖金,醋硫葡金,氢化可的松(副肾荷尔蒙),可的松,氟氢可的松,脱氢可的松,脱氢皮质(甾)醇,6α-甲基强的松,氟羟脱氢皮醇,倍他米松和地塞米松;止血剂,如凝血酶,抗血纤溶环酸,肾上腺素;以及抗血栓形成制剂,生物制剂,如液体溶液中的干细胞,蛋白质和酶也可以通过活性缝合线输送。伤口冲洗剂也可以通过活性缝合线输送。
另外的应用活性缝合线的方法和目的可以是通过管路施加真空从伤口吸出流体,管路连接到活性缝合线的近端,体液可直接从伤口处抽出。这提供了一种新的清除流体的方式,辅助伤口清洗程序。或者,可从伤口抽出流体进行分析以确定伤口的状态。例如,样品流体的化学信息可指示伤口治疗的进展,或对细菌的检测可实现伤口感染的早期诊断。
示例1
为了证明活性缝合线的分配流体到周围组织的能力,采用PET编织缝线进行生物体外实验,编织缝线包含终止于编织缝合线内的聚丙烯管,如图1b和4a所示,实验中活性缝合线多次穿过凝胶,其后连接到静脉传输系统,将含有蓝色素的水输送到插入凝胶的部分活性缝合线。图10a,10b和10c显示多个不同时间段的图像。图10a的图像取自实验开始时,显示了插入凝胶72的活性缝合线70。活性缝合线70上的黑色标记表示内部通道终止的位置。随时间过去,色素76围绕活性缝合线散开,如图10b所示。最终,如图10c所示,流体散布包围伤口周围的整个区域。
示例2
如果活性缝合线用于伤口闭合和流体传输,将内部通道结合到活性缝合线不应当损害缝合线的拉伸强度和结拉伸强度,使其低于标准的可接受水平。具有美国药典(USP)标准尺寸0和2的PET编织缝合线的结拉伸强度根据美国药典标准23进行了测量,其中聚丙烯管沿芯线插入缝合线。尺寸0号缝合线含有外径大约130微米和内径大约75微米的管路,尺寸2号缝合线含有外径大约为230微米和内径为大约135微米的管路。在各次实验中,对每个USP规格测试至少10个样品。芯部含有聚丙烯管路的PET编织缝合线的性能很容易超过USP标准设置的最低性能要求。2号尺寸的平均结拉伸强度值为13.5磅,0号尺寸的强度值为7.7磅。
示例3
实验数据显示出,挤出的聚丙烯聚合管,其外径在0.05英寸到0.10英寸的范围,弹性模量在0.1到3Gpa的范围,外径小于内径的1.7倍,当管路嵌入的编织缝合线具有形式上类似于手术所用结的平结时,会发生屈服和损坏。对聚合管进行类似实验,其中聚合管包括聚乙烯和聚四氟乙烯管,弹性模量在在0.1到3Gpa的范围,外径与内径之比大于2.3,活性缝合线的平结内侧完全未损坏,流体确实能通过打结部分传输。对于要打结的活性缝合线,最好外径与内径的比大于1.7,外径与内径的比大于2.0更好。在这些实验中,管路插入聚乙烯对苯二酸盐纤维制造的编织缝合线,USP尺寸范围从2-0到5。其他可影响结内腔损坏可能性的参数包括嵌入了内部通道的编织缝合线的厚度,流体传输管的强度,和形成结所用的张力。
Claims (9)
1.一种缝合线,包括:
第一编织缝线,具有近端、远端及外径;
至少一个通道,与至少一部分所述第一编织缝线同轴,具有近端、远端及直径,所述直径小于所述第一编织缝线的外径;和
涂复纤维束或涂复编织缝线,嵌入在所述第一编织缝线中并且与至少一部分所述第一编织缝线同轴,
其中,至少一个通道的远端设置在所述第一编织缝线的近端和远端之间,所述至少一个通道位于所述涂复纤维束或涂复编织缝线内。
2.根据权利要求1所述的缝合线,其特征在于,所述涂复纤维束或涂复编织缝线具有一个或多个孔,连接至少一个通道到涂复纤维束或涂复编织缝线的外表面。
3.根据权利要求1所述的缝合线,其特征在于,还包括连接件,位于所述至少一个通道的近端;所述连接件可直接或间接连接到皮下注射针、静脉内输送系统或流体泵。
4.根据权利要求1所述的缝合线,其特征在于,还包括位于所述至少一个通道的近端的可膨胀容器。
5.根据权利要求4所述的缝合线,其特征在于,还包括用于将所述可膨胀容器连接到所述至少一个通道的近端的连接件。
6.一种缝合线,包括具有外径的第一编织缝线,具有嵌入所述第一编织缝线中的涂复纤维束或涂复编织缝线,与至少一部分第一编织缝线同轴,所述涂复纤维束或涂复编织缝线的外径小于第一编织缝线的外径,所述涂复纤维束或涂复编织缝线具有一个或多个开口。
7.根据权利要求6所述的缝合线,其特征在于,还包括连接件,位于所述涂复纤维束或涂复编织缝线的一端;所述连接件可直接或间接连接到皮下注射针、静脉内输送系统或流体泵。
8.根据权利要求6所述的缝合线,其特征在于,还包括位于所述涂复纤维束或涂复编织缝线一端的可膨胀容器。
9.根据权利要求8所述的缝合线,其特征在于,还包括用于将所述可膨胀容器连接到所述涂复纤维束或涂复编织缝线一端的连接件。
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US7875055B2 (en) | 2011-01-25 |
CN1909842A (zh) | 2007-02-07 |
US20050125035A1 (en) | 2005-06-09 |
US20050125034A1 (en) | 2005-06-09 |
US8257393B2 (en) | 2012-09-04 |
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