CN1218378A - 软组织闭合系统 - Google Patents
软组织闭合系统 Download PDFInfo
- Publication number
- CN1218378A CN1218378A CN97193986A CN97193986A CN1218378A CN 1218378 A CN1218378 A CN 1218378A CN 97193986 A CN97193986 A CN 97193986A CN 97193986 A CN97193986 A CN 97193986A CN 1218378 A CN1218378 A CN 1218378A
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- Prior art keywords
- implant
- intubate
- transporter
- pipe
- distal end
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Images
Classifications
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- A—HUMAN NECESSITIES
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/043—Proteins; Polypeptides; Degradation products thereof
- A61L31/044—Collagen
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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
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Abstract
公开了植入物传送系统,该系统包括检测器(15),该检测器具有设置在插管(11)的远侧端处以便检测在腔内流动的体液的存在的探针(40),借此将该植入物(13)安置在该腔壁上。该植入物还包括保持件(14),该保持件滑动地设置在该插管内以便在将该插管从该植入物上取出时将该植入物保持在该腔壁上。
Description
本发明领域
本发明总地涉及用可自膨胀的、可生物再吸收的生物聚合体植入物对软组织部位进行闭合和填充的技术,特别是涉及对经皮刺穿部位进行闭合的技术。本发明具体涉及用这样的传送装置传送这种植入物,该传送装置刺入软组织部位一定深度以便止血和使伤口闭合。本申请还公开了制备该种植入物的方法。
本发明背景
将一插管穿过一穿刺部位插入到血管中对该血管进行治疗已经成为通常的做法,本领域已知为经皮经管腔血管成形术(percutaneoustransluminal angioplasty)的方法。在该方法中,将一个插管器鞘(introducer sheath)穿过穿刺部位插入到动脉中,使得一个气囊或其他类型的导管能够插入到血管中以便在血管内完成该过程。该方法和相关的方法的并发症之一是在将导管和插管器鞘撤去后经皮刺穿部位出血。为了止血,要在刺穿部位处施压直到血止住为止。由于血管成形术和相关的治疗方法常常需要使用抗凝剂,因此施压的方法并不总是有效而且可能需要较长时间的施压,并且偶尔还需要外科治疗。在某些情况下,甚至需要长期住院治疗。
本发明概述
本发明涉及在成形术和相关的治疗后在生物体内穿过组织的切口处和腔管壁处精确地传送植入物以便止血。该植入物是用适合于闭合该切口的材料制成的(例如,一种可自膨胀的、可再吸收的止血和闭合伤口的植入物)。
在本发明的总的方面,植入物传送装置包括一个与插入到切口内的插管固定连接的检测器,以便检测在腔管内流动的体液,借此将植入物设定在腔管壁上。该植入物进一步包括一个可滑动地设置在插管内的保持件,以便在将插管从切口处拔出后将植入物固定在腔管壁上。
优选实施例可以包括一个或多个下述的特征。
检测器包括一根管(例如毛细管),靠近该管的远侧端处具有一个管孔用来接收腔内流出的液体。该管孔将液体传送到管内。为了将植入物置放到腔管壁内,要使管孔重复地进出该腔管。在一个实施例中,该管具有一个密封的远侧端,并且将管孔设置在远侧端的管的侧面上以便通过该管将液体传送到安置在活体外靠近插管近端的管的近端。该管的近端具有一个供传送的体液排出的开口。例如,该管可以制造的很细(例如毛细管)。在另一个实施例中,将一个压力监测器连接到该管的近端处的开口处。在这种情况下,该管可以具有较使液体流到管的近端的实施例中要宽些的尺寸,以便能够探测到在管内空气的压差。而且,该管的远侧端不必密封,而是可以在远侧端具有管口以便探测在血管内流动的血液的收缩压。
在另一个实施例中,检测器包括一个设置在插管的远侧端部分的压力传感器。将该传感器移进移出腔管以便探测腔管内外的压差,借此将该植入物设置在该腔管壁上。
该保持件可以包括一个细长件,该细长件在其远侧端处有一个形成的扁平板,还有一个装接到该细长件的近端上的拇指托。
根据本发明的另一方面,使用下述的步骤来固定上述植入物传送装置在腔管壁处闭合切口。将该植入物放置在所述插管的远侧端部分内。接着将该插管固定在该切口内以便探测在腔管内流动的体液的存在,借此将植入物固定在该腔管壁上。随后通过将插管从切口处撤除使植入物从插管中释放出并固定在腔管壁上。
在一个实施例中,将保持件滑动地安置在插管内,其中保持件的远侧端与植入物的近端相连接。在使用中,将压力施加在保持件的近端上,同时撤除插管。
根据本发明的另一方面,将植入物设置在活体以闭合住贯穿组织和腔管壁的切口的方法包括下列步骤。将植入物设置在插管的远侧端部分内。接着将检测器与该插管以固定连接的方式设置。随后将插管和检测器安置在切口内。移动该插管和检测器以便探测在腔管内流动的体液的存在,借此将植入物设置在腔管壁内。然后将植入物固定在腔管壁上,同时将插管和检测器从所述切口处撤掉。
该植入物是一种可再吸收的、可自膨胀的组织和伤口闭合植入物,并且一般被制成一种由生物纤维构成的干燥的经压缩的多孔基质。这里所指的“生物纤维”包括胶原、弹性硬蛋白、纤维蛋白和多糖中衍生的天然纤维,以及通过例如重组DNA方法的生物工程方法制成的天然纤维的生物合成类似物。在本发明优选的形式中,所述基质是由动物或人体的胶原基础的纤维构成的。
特别是,本发明的经压缩的多孔基质包括一种密度大约为0.05g/cm3(最好是约0.1g/cm3到约0.3g/cm3之间)的基质,并且在干燥状态下微孔的尺寸约为0.5μm到约50μm(最好是介于约1μm到10μm之间)。微孔的尺寸定义为细长形微孔的间隙距离并且通过在下面给出的工作实施例中描述的方法或任何其他类似的方法加以测量的。此种经压缩的基质在与水性介质接触时自身会径向膨胀,导致微孔的尺寸从约100μm膨胀到完全膨胀时的约1000μm,相应体积的膨胀从大约2cm3/cm3增加到约100cm3/cm3(最好是从约10cm3增加到约30cm3/cm3);而密度则减小到约0.01g/cm3到0.10g/cm3(最好是减小到约0.02g/cm3到约0.06g/cm3)。最好是,该植入物的尺寸在压缩状态下介于1mm到6mm之间的范围,而在完全膨胀状态下介于5mm到50mm之间,高度的范围则介于2mm到100mm之间,该高度在两种状态下几乎是相同的(例如,在膨胀状态下的高度只比压缩状态下的高度大10%或20%)。该植入物具有1秒到60秒的松弛恢复时间(最好是1秒到20秒),它可通过在下面给出的工作实施例中描述的方法或任何类似的方法测量出。
在其范围最广的实施例中,制造可再吸收的、可自膨胀的组织闭合植入物的方法包括:
a)形成包含生物纤维的水分散液;
b)将该水分散液倒入铸模中;
c)对该水分散液进行冷冻干燥;
d)通过使用交联剂进行处理使经冷冻干燥的基质交联;
e)向交联的基质上喷水雾;接着
f)压缩经水雾处理过的基质。
本发明的可再吸收的、可自膨胀的软组织伤口闭合植入物是这样构成的,使基质高度压缩以便提供最大的体积膨胀能力和表面积用以吸收液体、促使血小板粘连和止血,同时保持最小的插入体积。高度多孔的基质一旦膨胀还可提供最大的表面积以便使细胞浸润和粘连而使伤口愈合。
本发明的其他特征和优点可从下面的附图、详细说明和权利要求中显而易见。
附图的简单描述
图1是软组织闭合系统的纵向截面图,该系统包括植入物传送装置和设置在其内的植入物。
图1A是图1所示的植入物传送装置远侧端和植入物的放大视图。
图2和2A以剖视图的方式描绘了在经皮穿刺部位传送植入物的软组织闭合系统的使用。
图3是植入物传送装置的放大视图,其中植入物得到适当的放置。
图4示出了外侧管状件撤除到植入物上方的状态。
图5是本发明的一个替换实施例。
图6是本发明的另一个替换实施例。
图6A是图6所示的实施例的远侧端的放大视图。
优选实施例的说明
参见图1-3,其中相同的编号表示同样的零件,一个软组织闭合系统10包括一个设置在植入物传送装置12内的植入物13。该传送装置12的主要功能是在病人软组织上具有一个缺口的需要的部位处传送植入物13并且填充和闭合住该缺口。
参见图1所示,传送装置12是用任何生物相容性材料制成的,这种材料包括不锈钢、合成聚合材料(例如,聚乙烯,聚丙烯,聚氯乙烯,聚苯乙烯,聚四氟乙烯,聚氨基甲酸乙酯),天然聚合物(例如,胶原,弹性硬蛋白,多糖)和本领域技术人员所熟知的其他的此类生物相容性材料。最好是,传送装置12是用廉价的一次性使用材料制成,以便在使用过后可以将其丢弃掉。为了易于制造和处理,最好使用合成聚合物。
植入物传送装置包括一个具有一细长体的插管11,该细长体从一可插入的前端部分32延伸到在其远侧端处的一个出口20。插管11的尺寸要使得其能够滑动地接收一个保持件22,该保持件是从插管11的近端28处导入的。
该保持件22包括一个细长圆筒形的杆状件24,该杆状件具有一个装接到其远侧端上的平板14和一个装接到其近端上的拇指托26。该平板和拇指托设置在垂直于杆状件24的纵向轴线的平面上。平板14的外侧尺寸稍小于插入部分32的内侧尺寸,以便使得杆状件24能够沿着插入部分32的纵向轴线向下滑动并且将植入物13保持在出口20处。
植入物传送装置12还包括一个窄管15,该窄管具有一个密封的远侧端39和一个在插管的出口20上方处的管的外侧上的侧孔40。侧孔40起探测从动脉进入侧孔40内的血流的探针的作用。当将插入前面部分32插入到穿刺部位内,并且使得侧孔40刚好延伸超过血管壁时,血液就流向近端开口35。一旦将侧孔从血管撤离并且使其被血管壁封闭住,血液就停止流到近端开口。血液不再从窄管15的近端开口35流出的位置就是传送装置的插入深度。不言而喻,传送装置12可能需要转动,使得侧孔40所在平面能够面对在血管内的血流的方向。
插管11最好构造成使其外径稍稍小于通常在管腔内方法中使用的插管器鞘的内径,以便于将插管11穿过经皮穿刺部位处的皮肤插入。根据具体的管腔内方法,外径可以在约1mm到约6mm之间变化。插管11还包括一个凸缘状凸起部30,该凸起部的轮廓要使得其在通过撤回插管11由保持件22释放植入物13时,使用者的手指可以将其抓住。凸缘状凸起部30在其近端28处可以是完全地或部分地环绕着管状体11。
植入物13安置在插管11内,与在其远侧端处的开口20共同扩张。保持件22被滑动地导引到插管11内,使得其平板14与植入物的近端接触。在插管11的近端处的锁定螺钉53可以用来将保持件22相对于插管11固定住。
在使用中,如图2和2A所示,将植入物传送装置12慢慢地导引到切口内直至窄管15的侧孔40进入血管44内。流过血管44内的血流进入侧孔40内并且通过窄管15流到近端开口35内,由此表明已经到达血管的穿刺部位。在多数外科手术中,一般最好使用一个插管器鞘(未示出)来导入植入物传送装置。不过,重要的是应将插管器鞘从血管处撤离,最好是撤离到距皮肤距离的至少三分之一处。
如图三所示,将植入物传送装置12撤回直到血液停止流到近端开口35内,表明侧孔40已经从血管处撤离并且由血管壁45封闭住。要注意的是,侧孔40的直径最好与血管壁45的厚度差不多。为了确保准确定位,操作者可以反复地前后(在图2所示箭头的方向上)移动传送装置。
虽然血液可能会通过侧孔40进入窄管15内,但操作者通过血流在压力下从血管突然流出到近端开口35可以判断侧孔40已经进入到血管44内。而且,当插管器鞘与植入物传送装置12一起使用时,该传送装置一般都构形成能够在该器鞘内相对贴紧地镶嵌住,以便在其穿过插管器鞘时插管器鞘的内壁可以密封住侧孔40。另外,植入物13在传送装置12导入过程中开始迫使切口内的血液回流,而植入物13则开始吸收血液。
参见图4,在将微弱的轴向压力施加到保持件22上以便保持植入物13在穿刺部位的位置的同时,将插管11回抽到植入物13和保持件22上方直到插管伸到植入物13的近端外为止。重要的是要注意,施加到保持件22上的压力只需要足以保持植入物13的位置就可以了,而不需要使其在血管44内的位置推进。然后将管状件和保持件两者都从切口处抽回留下植入物13合适地定位在血管壁内。当将传送装置慢慢地去掉时,已释放的植入物13快速地在位膨胀从而完全地闭合住穿刺部位。一般需要用人工施加压力到皮肤的缺口上持续足够时间以使得植入物13能够膨胀闭并闭合该缺口。
其他的实施例都在权利要求书的范围内。例如,参见图5所示,在另一个实施例中,将一个压力监测装置50连接到管54的近端52上。压力监测装置50可以是一种市场上可得到的监测器,例如,巴尔的摩的戴维斯仪器公司生产的型号为DPM200PS的微型数字压力表MD或仅仅是一个密封管。当孔41处在血管44内部和外面时,就可探测到在管52内血流上方空气的压力差。换句话说,通过表示在密封管内的血液的脉动的压力监测器的读数来确定植入物相对于血管壁的位置。当将管52从血管44内刚好移动到血管壁外侧时,压力从收缩压读数变化到衰减(damped)压读数或从从密封管内没有血液时的搏动变化到其内有血液时的血液衰减。要注意的是,与上面结合图1-4所讨论的实施例不一样,管54不必具有较窄的尺寸,因为血液不需要流动到近端52。相反,如图5所示那样,管54可以具有较宽的尺寸或其他的几何形状,只要其近端连接到一个压力监测器或一个密封管上。还应注意的是,在管54的远侧端处的孔可以设置在该管的远侧端处或沿着该管的侧面设置。如图5所示那样,孔41设置在管54的远侧端处(例如,该远侧端不必加以密封)。在此位置处的孔41仍能够检测到在血管内的血液的搏动。
在另一个实施例中,如图6和6A所示那样,探针可以是压力传感器60的形式,该该传感器设置在插管11的远侧端以便直接探测血管内外的压力差。在此实施例中,压力传感器60经电线64连接到压力监测设备62上,并且可以是可从市场上买到的微型机械式、微型电子式或电力机械传感装置的形式。
在上述实施例中,使用了软组织闭合系统来闭合在动脉上的经皮穿刺的穿口。然而,从上面的讨论中应该理解到,本发明还可应用到在其他的导管或腔管中的开口上。这种开口可能是外科手术导致的,包括与在除去恶性肿瘤,坏死组织,变质组织,深度子弹创伤,刀刺伤等后填充开口相关的那些开口。由整形外科或整容外科等手术造成的开口也可以使用闭合系统10进行填充。此外,闭合系统10可以用来止血和填充在使用活组织检查针或其他活组织检查设备的活组织检查应用过程中造成的开口。
植入物13主要由像蛋白质、多糖等生物聚合物制成。最好是,使用一种基于胶原材料,因其有内止血特性。
Ⅰ型至ⅩⅨ型胶原在制备植入物13时既可以单独使用,也可以组合使用。最好是使用Ⅰ型胶原,因这种材料可以大量得到,分离和纯化简便,以及具有得到证实的止血特性。Ⅰ型胶原的主要来源是腱,皮肤,骨头和韧带。人和动物的组织都可以用来分离胶原。通常,最好是使用动物组织,因为从当地的屠宰场容易获得较新鲜的原料。
在制备植入物13的过程中,先将Ⅰ型胶原分离和纯化。制备胶原的综述可以在“酶学方法”1982年第82卷第33-64页上查到。特别地,本发明的胶原可以通过下面的方法进行制备。
首先,先将Ⅰ型胶原的天然原料,例如皮肤,腱,韧带或骨头,清除掉脂肪,筋膜和其他无关的物质并且加以清洗。接着将经干净并清洗过的含胶原的原料通过切割或研磨的方式弄碎。随后将骨质原料进行脱矿质处理。这可通过使用像盐酸那样的酸溶液或使用像乙二胺四乙酸那样的螯合物剂溶液来达到。
然后使用像乙醇,丙醇,醚或醚和醇的混合物那样的脂溶性试剂对该原料进行去脂处理。接着将经去脂的含胶原原料在中性盐溶液中加以萃取,以便去除中性盐可溶解的物质。一般地说,为此目的要使用1M NaCl的溶液。高离子强度盐溶液会减弱经过溶解和去除的非特异结合的非胶原性的物质。然后将盐萃取过的含胶原物料用去离子蒸馏水加以清洗。
接着在使结构稳定的盐存在的情况下对中性经盐萃取过的含胶原的物质进行酸萃取,以便进一步去除掉可溶于酸的非胶原物质。适用的酸包括醋酸,乳酸,盐酸,硫酸,磷酸等等。不管使用的是哪一种酸,酸溶液的pH值都要调至3以下。所用的盐包括氯化钠,硫酸铵,硫酸钠等。酸萃取减弱了胶原与溶解和去除掉的酸性非胶原杂质间的相互作用。
然后通过加入碱将pH值从约6至约7调至其等电点的方式予以中和。适用的碱包括氢氧化钠,氢氧化钾,氢氧化铵等。通过加入碱,胶原凝聚。然后用本领域所熟悉的方法例如在真空下使用不锈钢筛网过滤器对凝聚的胶原进行过滤。
随后用去离子蒸馏水清洗经酸萃取、经碱中和过的胶原,以便去除掉中和过程中所形成的残留的盐。接着在存在使结构稳定的盐的情况下对清洗过的胶原进行碱萃取处理。这类碱在本领域中是众所周知的,例如氢氧化钠,氢氧化钾和氢氧化钙。无论使用哪种碱,都要将溶剂的pH值调至大于13。碱萃取可减弱胶原与碱性非胶原杂质之间的相互作用。通过加入碱,可将非胶原物质溶解和去掉。由于胶原内的可产生额外羧基团的谷氨酰胺和天冬酰胺的部分脱酰胺作用,碱还降低了等电位点。接着通过将酸加入到胶原分散液中来将pH值从约4.5至5.5调至其等电点的方式,使经碱萃取的胶原发生凝聚,以便将纤维从溶剂中完全分离出来,从而便于过滤。这些酸包括盐酸,硫酸,醋酸,乳酸,磷酸等。接着对凝聚的胶原进行过滤。在倒掉萃取液之后,用去离子蒸馏水对这些纤维进行清洗,以便去掉萃取液中和过程中所产生的残留盐。将这样纯化过的胶原保存在冰箱中或以冷冻干燥形式保存,用于制备胶原可植入物13。
为制造一种胶原可植入物13,先以本领域众所周知的方法制备一种胶原分散液。在美国专利第3157524号中公开了一种这样的制备方法。在美国专利第3520402号中则公开了另一种制备胶原分散液的方法。
具体地说,本发明的胶原分散液可按下面的方法进行制备。
首先纯化的胶原物质在1×10-4M的NaOH溶液中予以分散以使胶原纤维溶胀。接着用任何常规的方式,例如用混合器或均化器对胶原物质进行均化,以便使纤维充分分散。然后通过本领域众所周知的方法,例如通过使分散液通过不锈钢筛网过筛的方式,对经均化的胶原进行过滤以便去除掉所有未溶胀开的聚合物。通过加入0.01M HCl,将分散液的pH值调至大约7.4。碱中的初始分散液允许在没有通过等电点的情况下进行中和步骤,以便不会产生胶原凝聚并且得到pH值为7.4的更加均匀的分散液。接着,对分散液进行真空除气。这样最终得到的胶原分散液就可以用来制备用于闭合软组织的可自膨胀的植入装置。
典型地,分散液中的胶原的重量百分比大约为0.5到约5.0,最好是介于约0.75到约2.0的范围内。通过将分散液在离心机中离心并且去掉上清液的方式,可以使分散液中的胶原重量百分比高于5.0。一般地说,施加到分散液上的离心力越大,在去除掉上清液之后的分散液中的胶原重量百分比也越高。
在本发明的一个实施例中,如果胶原软组织闭合系统要用来起药物传送器的功能,则除了Ⅰ型胶原外,在所述分散液中可以任选地包含有药物添加剂,例如抗菌素,凝血酶,多糖如透明质酸,硫酸软骨素,藻酸,壳聚糖等,生长因子如表皮生长因子,转化生长因子β(TGF-β)等,糖蛋白如纤连蛋白,Laminin等,Ⅱ型至ⅩⅨ型胶原及其混合物。
随后将胶原分散液倒入到铸模中,铸模的形状可以是圆柱型的,长方形的,球形的或其他任何形状。铸模的尺寸和形状可以设计成能够得到最佳的物质以便进一步处理。最好是,使用圆筒形的铸模来闭合住穿刺的伤口部位。铸模的尺寸要大于可插入的前端部分32的内径。例如,对于一个2mm的内径(I.D.)的可插入前端部分32,和一个圆筒形的可植入胶原物13而言,铸模的直径最好在约3mm至约15mm的范围内,而铸模的高度在约5mm至25mm的范围内。
然后将含有分散液的铸模放置在一个冰箱内,冰箱的温度要保持在约-10℃到约-50℃的范围内持续一段足够的时间以使得存在于分散液内的水结冰,一般来说约1小时到约24小时。接着对冰冻的分散液进行冷冻干燥,以便去除掉结冰的水。此冷冻干燥处理是在市售的冷冻干燥器,例如由Virtis,Stokes或Hull制造的干燥器内在本领域内技术人员熟知的条件下进行的。通常,干燥室内的真空保持在约50mm的Hg到约300mm的Hg,温度保持在约-10℃至-50℃下持续约16至约96小时。然后将温度升高到约25℃持续约3小时到24小时。
然后对干冷的、高度多孔的胶原基质进行交联处理,用于引入另外的分子间交联以便稳定胶原基质的结构。交联是通过使用本领域众所周知的方法进行的。任何可以与能够键合不同的胶原分子的侧链的氨基、羟基、胍基、羧基发生反应的试剂都可以用来交联胶原基质。这可以用硫酸铬,甲醛,戊二醛,碳二亚胺,己二酰二氯,1,6-己二异氰酸酯等来完成。胶原体内再吸收率取决于胶原基质中分子间交联的程度。控制交联程度的因素是交联剂的种类和浓度;液相的pH值,及在液相中的时间和孵育的温度;或当交联在汽相中完成时交联剂的蒸汽压,持续的时间,温度和相对湿度。最好是,本发明的胶原基质交联到这样的程度,使得胶原在约2至约10周内完全被吸收。
冻干基质的恰当的交联可以导引出了用作为软组织闭合装置于特殊的医疗用途的本发明的若干非常重要的特性。
例如,有效的交联锁定由铸模的形状决定的基质的物理几何形状。因此,当将压力施加到基质上时,基质表现得很有弹性。也就是说,当基质后来被物理压缩时,一旦放松或撤去外部压力,它就会恢复到其初始形状和尺寸,或膨胀到这样的程度使得其能够贴合住有形屏障例如穿孔的孔壁。经恰当交联过的冻干胶原基质的弹性特征在胶原基质处在湿润状态下,例如当其在穿刺部位处吸收血液时,表现得特别明显。这是胶原基质的亲水性和Donnan渗透压的结果。在湿润状态下从压缩状态恢复到其原状的恢复时间短到约1秒至约60秒。最好是,恢复时间在约1秒到约20秒的范围内。
从交联胶原基质导致的另一个重要的特性是,其从压缩状态到膨胀状态的体积膨胀能力。本发明的经交联的胶原基质的体积膨胀能力受到铸模的尺寸的限制,该铸模决定了本发明的基质的总体积。基质的总体积由铸模的几何形状所决定。通常,当铸模是圆柱体形状时,体积是由圆柱体的底面积和圆柱体的高度确定的。用于穿刺的基质的理想体积取决于所用的插管器鞘的特定的尺寸。举个例子来说,当使用9F(约3mm)的插管器鞘时,圆柱形基质的理想的尺寸要是这样的,底部尺寸在约6mm至约15mm之间,高度在约5mm至25mm之间。这意味着经压缩的基质的体积一旦传送并且自膨胀后将膨胀约3至20倍。
通过交联胶原基质的方式可以控制的另一个特征是其密度。根据要修补的特定的穿刺部位和物理的、化学的和生物的要求,经压缩的基质的密度在约0.05g/cm3到约1.0g/cm3的范围,而当基质处在完全膨胀时其密度可以在约0.01g/cm3到约0.1g/cm3之间变化。通常,为了闭合住由血管成形术或其他相关的手术导致的穿刺部位,基质在压缩状态下的密度可在约0.1g/cm3到约0.3g/cm3范围之间变化,而在完全膨胀下在约0.02g/cm3到约0.06g/cm3范围之间变化。
由交联胶原基质导致的另一个特征是交联基质的孔状结构。完全膨胀的交联的胶原基质的孔的尺寸在约100μm到约1000μm之间。在压缩状态下孔的尺寸急剧地下降到约0.5μm到约50μm之间。交联过的基质压缩可使得基质能够插入到较小的体积以传送,传送后基质随着进行的自膨胀可使得基质膨胀到贴合住穿刺孔的程度。
本发明的胶原基质的交联程度可通过基质的热液收缩温度(Ts)(hydrothermal shrinkage temperature(Ts))测得,即基质在液相环境下由于胶原分子的三重螺旋结构解旋导致的其尺寸开始收缩时的初始温度。测量物质的收缩温度的方法在本领域中是众所周知的,例如通过使用差式扫描量热计,或通过使用高差计测量尺寸的变化。一般地说,交联的程度要达到使胶原基质的收缩温度处在约50℃到约75℃的范围内,最好是处在约55℃到约65℃的范围内。
作为一个实例,胶原基质可以与甲醛蒸汽交联。无论是市售的甲醛蒸汽,还是从甲醛溶液制得的甲醛蒸汽都可以用。特别是,交联可以在室中进行,其中相对湿度介于约80%到约100%的范围内,最好是处在约85%到约95%的范围内,并且在存在过量的甲醛蒸汽的情况下,在约25℃的温度下保持约30分钟到约8小时的时间。尤其是,通过由1%甲醛溶液在25℃和95%湿度下保持60分钟所产生的甲醛蒸汽进行交联可产生一种收缩温度介于约55℃到约65℃范围内并且在完全膨胀下基质密度在约0.02g/cm3到约0.1g/cm3范围内的胶原基质。
接着可以对交联的胶原基质进行水雾处理。任何市售的水雾喷雾器都适用于此目的。例如,在胶原基质在容器中在约25℃温度下翻滚时,可以对胶原基质喷洒约10到60秒。然后将经水雾处理基质在封闭容器中平衡约30分钟,以便进一步软化基质用于随后进行的压缩步骤。由于此水处理的结果,胶原基质吸收了约10到40%重量的水,该百分比是以干燥物质重量为基础计算的。接着对经过水雾处理的胶原基质进行机械压缩以便减小其尺寸,从而使得其适合插入部分32内。
特别是,当基质是圆柱形时,要将机械压力施加到径向方向上,以便使得底面积减小到与可插入部分32的内径大致相当大小。一般地,经压缩的胶原基质的体积约为未压缩的基质的1/100到1/2。接着将经压缩的胶原可植入物13插入到可插入前端部分32内。此时,将已经装好的软组织闭合系统个别包装以消毒。
基质的交联,水雾处理和机械压缩都是本发明的重要内容。更重要的是,本发明中所描述的操作顺序是使胶原基质具有理想特性的关键。经压缩胶原植入物的密度,孔状结构和体积膨胀的程度都直接涉及到怎样制造胶原基质物质。例如,将本发明的次序改为先进行水雾处理,接着机械压缩,然后对基质进行交联将会导致这样的基质,即在释放了压力后基质不能够自膨胀并且不具备血液吸收能力。
不需要进一步的描述,相信本领域的技术人员基于上述描述已经能够最充分地利用本发明。因此,下面的具体的实施例仅仅是说明性的,无论如何都不是对所公开内容的其余部分的限制。本申请所引用的所有出版物,包括美国专利,都通过引用结合在本申请中。胶原分散液的制备
将牛的屈肌腱的脂肪和筋膜仔细地清除掉并且用水加以清洗。将清洗过的腱冷冻并通过用切片机切成0.5mm的薄片的方式将其弄小。先将腱用异丙醇脱脂(腱∶异丙醇=1∶5体积比),在25℃下不停地搅拌8小时。去掉萃取液,加入相同体积的异丙醇,接着将腱的薄片在25℃下不停地搅拌萃取过夜。随后用去离子蒸汽水充分地清洗腱以去除残留的异丙醇。随后将脱脂的腱用10倍体积的1M NaCl在4℃下不停地搅拌萃取24小时。接着将经盐萃取的腱用去离子蒸馏水加以清洗。然后,在存在1M Na2SO4的条件下,在25℃不停地搅拌下用10倍体积的1.0M NaOH萃取纤维24小时。接着将经碱萃取过的胶原通过过滤予以收集并且用0.1M HCl加以中和,并且收集纤维,清洗以便去除掉残留的盐,随后加以冰冻。
首先取一份上述纯化的纤维悬浮在1×10-4M NaOH溶液中。所使用的纤维和碱溶液的量要能够得到一种1.5%(重量/体积)的胶原悬浮液。接着将溶胀的纤维在一个不锈钢混合器中均化60秒。将这样分散的胶原物质通过一个40mm不锈钢筛过滤。接着通过加入0.01MHCl将分散液的pH值调节到约7.4。然后通过真空对所述分散物进行脱气并且储存在4℃下待用。胶原软组织闭合植入物的制备
将用上面描述的方式制备的胶原分散液倒入直径为15mm,高度为10mm的不锈钢铸模内。接着使用市售的Virtis冷冻干燥器对含有胶原的铸模进行冷冻干燥处理。冷冻干燥的条件是:在-40℃下冷冻6小时,在-10℃的150μm Hg下干燥24小时,接着在25℃下干燥8小时。然后在具有过量的甲醛蒸汽(在25℃下由1%的甲醛溶液产生),相对湿度为95%的交联室中在25℃下对冷冻干燥的胶原基质进行甲醛蒸汽交联处理60分钟。接着,对交联的胶原基质喷洒水雾10秒钟,然后在密闭的容器中另外平衡30分钟。然后,通过在两个间隙为2.5mm的软的塑料板之间转动的方式对经水雾处理的基质进行压缩,使得海棉状基质的直径由15mm减小到约2.5mm。接着,将经压缩的胶原基质插入到内径2.5mm,外径为3.0mm的预先制备好的植入物传送装置内(图1中的部件11)。含有凝血酶的胶原软组织闭合植入物的制备
将胶原分散液与凝血酶均匀地混合(胶原∶凝血酶=10∶1重量/重量)。接着将充分混合的胶原/凝血酶凝胶用上述方式倒入到不锈钢铸模内。接着进行的步骤也与上面描述的一样。多糖软组织闭合植入物的制备
将壳聚糖(Sigma Chemicals,圣路易斯,MO)溶解在1%的醋酸中。所使用的壳聚糖和酸溶液的量为使壳聚糖溶液为1.5%。取一份量的壳聚糖溶液要通过加入0.01M NaOH的方式慢慢地中和到pH值为6。将这样制备的溶液倒入到不锈钢铸模内并且按上述方式加以处理。胶原软组织闭合植入物的特性a)密度(g/cm3)
首先通过称量胶原基质的重量的方式确定在压缩和完全膨胀下的软组织闭合植入物的表观密度以便获得干重。接着通过海绵体的半径和高度根据公式:v=π×r2×h来确定基质的体积,其中r是基质的半径,h是基质的高度。本发明的胶原软组织闭合植入物的密度对于压缩基质介于约0.10g/cm3到约1.0g/cm3的范围内,对于完全膨胀的基质介于约0.01g/cm3到约0.1g/cm3范围内。b)体积膨胀能力(v/v)
体积膨胀能力定义为软组织闭合装置的每单位基质体积的体积膨胀。通过测量基质的尺寸的方式首先确定压缩的胶原基质的体积。接着将胶原基质浸入25℃下pH值为7.4的缓冲液中5分钟。然后测定膨胀的湿润的基质的体积。胶原基质的体积膨胀能力(v/v)是通过将膨胀基质的体积除以压缩基质的体积计算出的。本发明的胶原软组织闭合植入物的体积膨胀能力在约2cm3/cm3到约100cm3/cm3的范围内。c)孔的尺寸(μm)
通过对压缩和完全膨胀下的胶原基质的横截面的扫描电子显微照片(SEM)得到孔的尺寸。压缩基质的孔的尺寸定义为压缩的细长形孔的间隙宽度。膨胀基质的孔的尺寸定义为孔的最长距离和最短距离的平均值。本发明的胶原基质的孔的尺寸对于经压缩的植入物而言介于约0.5μm到约50μm,而对于充分膨胀的植入物而言介于约100μm到约1000μm之间。d)松弛恢复时间(秒)
将本发明的压缩下的胶原软组织闭合植入物从一次性的传送装置推出送入到25℃ pH值为7.4的缓冲液中。经压缩的基质开始松弛,生成水合物,然后自膨胀到充分膨胀状态。将它恢复到充分膨胀状态的时间记录下来。本发明的松弛恢复时间介于约1秒到约60秒的范围内。e)收缩温度(℃)
先将胶原基质的10mg的样品在pH值为7.4的缓冲液中浸湿。接着将样品密封进一个铝制样品池(pen)中并且插入到一个差式扫描量热计内。使用缓冲液作为参照物。加热速度为5℃/min。收缩温度定义为从热能随温度变化的曲线图中得到的吸热峰对应的点。本发明的胶原软组织闭合植入物的热收缩温度的范围介于约50℃到约75℃之间。胶原软组织闭合植入物的使用(带鞘)
将合适尺寸的胶原软组织闭合植入物插入到穿刺部位处,其中插管器鞘已经部分地取下。将胶原植入物释放至穿刺部位并且允许其充分水合并在原位处自膨胀5分钟。以上面描述的方式完成上述的步骤。接着将传送装置慢慢地抽回,在伤口上施加轻微的压力持续2到5分钟以便确保完全地止血和使伤口闭合。胶原软组织闭合植入物的使用(不带鞘)
将装有胶原植入物的尺寸合适的传送装置穿过经皮部位插入到目的组织部位。接着将胶原植入物以上面描述的方式从管状传送装置中释放出来。胶原植入物自身就膨胀以便充满软组织部位的空隙。其他实施例
从上面的描述中,本领域技术人员可以很容易地明白本发明的主要特征,而且在不脱离本发明的精神和范围的情况下,可以对本发明作出各种各样的变化和变更,以便使其适合于各种用途和情况。因此,其他的实施例也在权利要求书的范围内。
Claims (20)
1.用于传送植入物到活体内的腔壁上的切口处的植入物传送装置,该植入物是用适合于闭合住切口的材料制成的,所述植入物传送装置包括:
具有欲插入切口内的远侧端部分的插管,该远侧端部分的构形能够将该植入物支撑在该插管内;
保持件,该保持件可滑动地安置在该插管内,以便在将该植入物插入到腔壁的切口处的过程中将该植入物保持在该插管的远侧端处;
以固定连接所述插管方式设置的检测器,所述检测器检测在腔内流动的体液的存在,借此将植入物设定在所述腔壁处,通过将该插管从切口处取出的方式可将该植入物释放在腔壁处。
2.权利要求1所述的植入物传送装置,其中所述检测器包括具有远侧端的管和接近该远侧端设置的孔以便接受从腔流入该管内的液体,该管具有设置在活体外部靠近该插管的近端的近端。
3.权利要求2所述的植入物传送装置,其中所述管的远侧端是密封的并且该管构形成能够通过该管向该管的近端传送液体。
4.权利要求3所述的植入物传送装置,其中所述管的近端具有供被传送液体排出的开口。
5.权利要求2所述的植入物传送装置,其中所述管的近端具有开口,而该检测器还包括连接到该开口上的压力检测器。
6.权利要求5所述的植入物传送装置,其中所述管构形成能够检测该管内的空气的压力。
7.权利要求1所述的植入物传送装置,其中所述检测器包括设定在该插管的远侧端部分的压力传感器。
8.权利要求1所述的植入物传送装置,该植入物传送装置包括设置在所述插管的远侧端内的压缩的可生物再吸收的植入物,所述植入物被浸湿时可径向膨胀,并且其体积的膨胀率在2cm3/cm3到100cm3/cm3的范围内,在其压缩状态下,孔的尺寸在0.5μm到50μm围内,而密度则在0.05g/cm3到1g/cm3范围内,在其膨胀状态下,孔的尺寸在100μm到1000μm范围内,而密度则在0.01g/cm3到0.1g/cm3范围内,松弛恢复时间在1秒到60秒的范围内。
9.如权利要求8所述的植入物传送装置,其中所述植入物的体积膨胀率在10cm3/cm3到30cm3/cm3的范围内,在其压缩状态下,其孔的尺寸在1μm到10μm范围内,密度在0.1g/cm3到0.3g/cm3的范围内,而在其膨胀状态下,其孔的尺寸在200μm到400μm范围内,密度在0.02g/cm3到0.06g/cm3范围内,松弛恢复时间在1秒到20秒范围内。
10.如权利要求8所述的植入物传送装置,其中所述植入物是用可生物相容和生物聚合的材料制成的。
11.如权利要求10所述的植入物传送装置,其中所述可生物相容和生物聚合的材料是胶原。
12.如权利要求9所述的植入物传送装置,其中所述植入物是用可生物相容和生物聚合的材料制成的。
13.如权利要求12所述的植入物传送装置,其中所述可生物相容和生物聚合的材料是胶原。
14.使用权利要求1所述的植入物传送装置的方法,该方法包括以下步骤:
将该植入物放到该插管的远侧端内;
将该插管安置在该切口内;
移动该检测器检测在腔内流动的体液的存在,借此将该植入物设定在该腔壁处;并
通过将压力施加到保持件的近端上同时将该插管从该切口处撤除的方式将该植入物保持在该腔壁处。
15.如权利要求14所述的方法,其中所述检测器包括具有密封的远侧端的管和设置在靠近该密封的远侧端的孔以便接纳从腔流入到该管内的体液,该管具有设置在活体外侧靠近该插管的近端处的近端,所述移动步骤是通过将该孔反复移进和移出该腔的方式完成的,以便将该植入物设定在该腔壁处。
16.如权利要求15所述的方法,其中所述将孔移进该腔管内的步骤会使得液体通过该管传送到在该管的近端处的开口处。
17.如权利要求14所述的方法,其中所述检测器包括压力监测器,所述移动步骤是通过将该传感器反复地移进和移出该腔,以及监测该腔的内外压差的方式完成的,借此将该植入物设定在该腔壁上。
18.如权利要求14所述的方法,其中所述检测器包括设置在该插管的远侧端处的压力传感器,所述移动步骤是通过将该传感器移进移出该腔并且监测该腔内外的压差的方式完成的,借此将该植入物设定在该管壁上。
19.如权利要求14所述的方法,其中所述保持步骤包括将保持件可滑动地设置在该插管内,该保持件的远侧端在该插管取出的过程中与该植入物的近端接触。
20.将用来闭合穿过组织和腔壁的切口的植入物安置在活体内的方法,该方法包括以下步骤:
将该植入物放入插管的远侧端内;
将检测器与所述插管固定连接;
将该插管和该检测器安置在该切口内;
移动该插管和该检测器以便检测在该腔内流动的体液的存在,借此将该植入物设定在该腔壁上;和
将该植入物保持在该腔壁上,同时将该插管和该检测器从该切口处取出。
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Also Published As
Publication number | Publication date |
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US6350274B1 (en) | 2002-02-26 |
TW358725B (en) | 1999-05-21 |
WO1998019605A1 (en) | 1998-05-14 |
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