CN101933824A - 自封闭组合物 - Google Patents
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- 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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- 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
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
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Abstract
具有伤口闭合装置和加固材料的医疗装置在原位反应以产生自封闭植入体。
Description
相关申请
本申请要求享有于2009年6月29日提交的第61/221,246号美国临时专利申请的优先权,将其全部内容在此引入作为参考。
技术领域
本公开涉及自封闭植入体,更具体地讲,涉及包含第一反应组分和第二反应组分的自封闭植入体。
背景技术
伤口闭合装置,例如吻合钉(staple)和缝合线,被普遍应用在手术中,例如,切除组织、横切组织和在组织与器官之间建立连接。更具体地讲,提供了包括线形的、环状的和弯曲的多种形式的伤口闭合装置(如手术吻合钉),用于包括血管、肥胖病、胸廓和妇产科的各种类型手术中。
曾有报道在某些方法中有流体(例如,空气和血液)渗漏。一个解决办法包括使用另外的加强件例(如支撑件(buttress))。支撑件或纱布可应用在吻合钉线上以对吻合钉线提供加固和/或对脆弱的组织提供加固。在使用过程中,吻合钉或缝合线一般是通过支撑件被射入或缝入。然而,仍需要补充加固材料的缝合线或吻合钉组合物,由此来减少潜在的渗漏。
发明内容
本公开的自封闭植入体包括至少一种伤口闭合装置和加固材料,其中,所述伤口闭合装置包括第一反应组分并且所述加固材料包含第二互补反应组分。更具体地讲,所述伤口闭合装置可包括吻合钉、缝合线、夹子、大头钉、螺钉、别针、锚、紧固件、护套、分流器、组织屏障、支撑架(stent)和移植物。所述加固材料可包括带、毡、支架(scaffold)、片、纱布、网和支撑件。
在一些实施方式中,第一和第二反应组分的至少一种包括自封闭装置涂层。在其他实施方式中,第一和第二反应组分的至少一种被选择性地沉积在自封闭装置上。
第一反应组分和第二反应组分可选自亲电子官能团和亲核官能团中。更具体地讲,第一反应组分和第二反应组分可包含选自含有琥珀酰亚胺基的聚合物和多官能团伯胺中的材料。
第一反应组分和第二反应组分的相互作用会产生水凝胶。
在另一个实施方式中,所述自封闭装置包括至少一种吻合钉和支撑件,其中,当至少一种吻合钉和支撑件发生相互作用时,形成水凝胶。吻合钉可进一步包含含有选自含有琥珀酰亚胺基的聚合物和多官能团伯胺中的材料的涂层。支撑件也可包含选自含有琥珀酰亚胺基的聚合物和多官能团伯胺中的材料。
自封闭装置可包含天然的以及合成的材料,如聚酯、聚醚酯、聚原酸酯、聚羟基链烷酸酯、聚羟基丁酸酯、聚酐、聚胺、聚酰胺酯、聚碳酸酯、硅酮、高分子药物、天然胶原、衍生胶原、牛心包、明胶、纤维蛋白、纤维蛋白原、弹性蛋白、角蛋白、白蛋白、羟乙基纤维素、纤维素、氧化纤维素、羟丙基纤维素、羧乙基纤维素、羧甲基纤维素、壳多糖、壳聚糖、酪蛋白、藻酸盐以及其组合。
本申请包括一种在原位产生自封闭装置的方法,其包括下列步骤:在组织上设置支撑件;从吻合器发射至少一个吻合钉;该至少一个吻合钉与所述支撑件接触;和,引发化学反应。
附图说明
下文将参照附图描述本公开的各种实施方式,其中,
图1为包含吻合钉涂层的手术吻合钉的侧面透视图;
图2为包括加固材料的手术吻合器的侧面透视图;
图3为沿图2的A-A线的包括吻合钉的手术吻合钉筒的横截面图;
图4A为本公开的一个实施方式的透视图,图示了吻合钉被射入支撑件进入组织;
图4B为图4A的局部放大图;
图5A-5B为图示本公开的一个实施方式中反应基团为NHS酯基和伯胺的侧面透视图;
图6A-6B为图示本公开的一个实施方式中反应基团为碳二亚胺和伯胺的侧面透视图;
图7A为图示根据本公开的一个实施方式的侧面透视图;
图7B为图示根据本公开的另一个实施方式的侧面透视图;以及
图8为根据本公开的另一个实施方式的平面图。
具体实施方式
本公开涉及一种自封闭医疗植入体。具体地讲,所述自封闭植入体包括含有第一反应组分的伤口闭合装置和含有第二互补反应组分的加固材料。第一和第二反应组分以未反应状态设置在该装置上或该装置内。在实施方式中,第一反应组分选择性地在原位与第二互补反应组分进行反应。更具体地讲,当发生相互作用或物理接触时,第一组分和第二组分发生反应。在某些实施方式中,生理液或溶液如水或盐水(以调整的pH或电离度)可以帮助引发两种组分之间的反应。
其中使用的术语“组织”包括,但不限于,组织,例如肺、大肠、皮肤、脂肪、筋膜、骨、肌肉、腱、韧带、实体器官、腔、导管、淋巴、神经和血管。
其中使用的术语“生理液”包括,但不限于,液体,例如血液、血浆、腹膜液、脑脊髓液、尿、淋巴液、滑液、玻璃体液、唾液、肠胃腔的内含物、胆汁和气体(例如,CO2)。
其中使用的术语“互补”是指第二反应组分经过化学调整以使选择性地或优先地与第一反应组分反应。换句话说,单个的两种组分都是稳定的,但是当它们配对在一起时(原位),就会引发化学反应。更具体地说,若不与互补的第二组分接触,第一组分不会独立发生化学变化。一旦在原位发生物理上的接触,两种反应组分发生化学变化(例如,形成交联聚合物)产生自封闭植入体。
一般来说,自封闭植入体包含含有第一反应组分的加固材料,而伤口闭合装置包含第二互补反应组分。图1-3图示了本公开的一种实施方式,其包括涂敷有第一反应组分的吻合钉2(伤口闭合装置),吻合钉2与包含第二互补反应组分的支撑件20(加固材料)在原位配对。更具体地讲,图1图示了涂敷有第一反应组分4的吻合钉2。一般来说,吻合钉2包括吻合钉腿2a,其间通过吻合钉反向间隔(staple backspan)2b连接。第一反应组分是以涂层的形式图示,但是第一反应组分也可以以其他的形式存在于吻合钉上,包括但不限于使反应组分复合在聚合物树脂内、选择性地施加反应组分的局部储存库、或另外将未反应的第一反应组分包埋在自封闭装置中。例如可以使用浸涂技术涂敷吻合钉2,但是其他涂敷方法也是本领域技术人员知晓的并将在后面讨论。如图所示,涂敷了整个吻合钉2,然而也可以预想到,可以只涂敷吻合钉2的一部分。例如,在某些实施方式中,可以涂敷吻合钉腿2a,而反向间隔2b保持未涂敷。在另外的实施方式中,可以在设置在吻合钉上的选择性表面进行图案式涂敷以和第二反应组分(和/或组织)进行交联。也可以预想到不同排的吻合钉(在手术吻合器中,例如Covdien,North Haven,CT的EndoGIATM)可具有不同的反应组分或者在吻合钉的表面可包括反应组分的不同的图案。例如,使最里排的吻合钉具有较大程度的交联(与加固材料和/或组织),而最外排的吻合钉具有较小程度的交联(与加固材料和/或组织)将会是有益的。
来看图2-3,多个吻合钉2设置在加载单元30中用于将吻合钉射入到组织中。图2显示支撑件20包含第二互补反应组分。例如,支撑件20是以单个的聚合物层状片来示例的,可以理解的是,支撑件并不限于单个层状片。第二互补反应组分22是以涂层的形式来示例的,但是第二互补反应组分22可以以其他形式存在于支撑件20上,例如复合在树脂里、在支撑件里的选择性交织线/细丝、或选择性地施加反应组分的局部储存库。可以使用本领域技术人员所知晓的任何技术对支撑件20进行涂敷。如图所示,涂敷了整个支撑件,然而也可以预想到,可以只涂敷支撑件20的一部分。例如,在某些实施方式中,支撑件的第一表面20a可包含反应组分,而第二表面20b不包含反应组分。在另外的实施方式中,支撑件的第一表面和第二表面都可被涂敷或包含不同的反应组分。例如,可用第二反应组分涂敷第一表面20a(与第一反应组分反应),而可用第三反应组分涂敷第二表面20b以选择性地与组织表面交联。加固材料也可具有选择性地在表面上图案化的或选择性地引入/设置在加固材料中(例如,局部储存库)的第二反应涂层。
支撑件20与吻合钉筒(staple cartridge)10相邻设置(图2-3),然而,也可以想到支撑件20设置在钉砧14上,或者支撑件20可同时设置在吻合钉筒10和钉砧14上。也可以预想到支撑件20可以预先装入加载单元30中,在另外的实施方式中,支撑件20可以在手术室中在植入前附着到加载单元30上。可以使用的集成的支撑件的一个例子为DUET TRSTM(Covdien,North Haven,CT),公开在于2007年3月6日提交的第60/905,532号美国临时专利申请中,其公开的全部内容在此引入作为参考。
图3图示了在吻合钉袋16中的一排吻合钉2沿“A-A”线的另一视图。支撑件20与吻合钉筒表面10a相邻设置,使得当吻合钉被发射时,吻合钉腿2a首先穿透支撑件20,然后刺穿第一组织表面(未示出),吻合钉腿2a接着穿出第二组织表面(未示出),在这里吻合钉腿2a与钉砧14上的吻合钉槽(未示出)接触,使吻合钉腿2a弯回到第二组织表面,完成了如图4A-4B所示的大体上为“B”形状的吻合钉的形成。当吻合钉2在原位被射出穿过支撑件时,生理液将第一和第二反应组分混合在一起,引发化学反应,产生自封闭植入体。
在几秒钟到几分钟内,第一反应组分和第二反应组分发生了化学反应,产生自封闭植入体。一旦未反应的组分在原位发生物理接触,这两种组分就混合并形成交联的聚合物网络。体腔中的生理液或水分会帮助两种反应组分的混合。一旦形成了交联的聚合物网络(水凝胶),膨胀的水凝胶就封闭任何存在的空隙空间。例如,存在于吻合钉腿上的水凝胶会膨胀,封闭组织内或支撑件内的任何空隙空间。
更具体地讲,在图5所示的一个实施方式中,自封闭植入体75包括具有位于表面的多个伯胺基的吻合钉80。所述伯胺可以以涂敷的方式或化学附着/沉积官能团的其他方式存在于装置80的表面上。加固材料90是以附着在其表面的琥珀酰亚胺基官能团来示例的。重复一遍,这些官能团可用本公开详述的各种方式附着在表面或包埋在装置里面。一旦吻合钉80和加固材料90在原位接触,在给定的大约7~大约10的pH范围内,在实施方式中,为大约7.5~大约9,在包括水、盐水或其他生理液的水分存在的条件下,两种反应组分发生交联。产生了自封闭装置75(图5B),其中两种反应组分使加固材料90和吻合钉80化学地相互交联,产生水凝胶。另外地,水凝胶会吸收周围环境里的额外液体,封闭周围区域里的任何空隙空间。随着时间的推移生成的水凝胶会经水解发生降解,释放出水溶性片段。自封闭植入体可经过化学修饰以在优选的时间范围内发生降解,例如,从大约1天至大约30天。
图6A-6B图示了与图5A、5B相似的实施方式,因此所有相似的部分将用相似的标记(prime mark)标明而只有不同的部分才在下面说明。示例的吻合钉80’具有设置在其表面上的多官能团伯胺基。示例的加固材料95具有附着在其表面的碳二亚胺官能团。一旦吻合钉80’和加固材料95在原位接触,在给定的大约7~大约10的pH范围内,在实施方式中,为大约7.5~大约9,在包括水、盐水和其他生理液的水分存在的条件下,两种反应组分发生交联。产生了自封闭装置75’(图6B),其中两种反应组分使加固材料95和吻合钉80’化学地相互交联,产生水凝胶。
本公开的第一或第二反应组分可包括天然的或合成的多官能团伯胺。其中使用的术语“多官能团”是指所述伯胺含有至少两个伯胺基。在一个实施例中,多官能团伯胺可包括在伤口闭合装置上的涂层,应该理解的是,可以使用将在后面详述的多种方法将多官能团伯胺引入到自封闭植入体中。在另一个实施例中,加固材料整体上包含胺化的葡聚糖支架,该葡聚糖支架选择性地与琥珀酰亚胺基功能高分子反应。合适的天然或衍生的伯胺见于下列材料(包括组织)中,例如胶原、白蛋白、弹性蛋白、多糖如壳聚糖、胺化的葡聚糖、改性纤维素和透明质酸、含有赖氨酸残基(包括聚乙二醇化的或大分子单体的形式)的聚赖氨酸或肽和/或蛋白质、含有精氨酸残基(包括聚乙二醇化的或大分子单体的形式)的聚精氨酸或肽和/或蛋白质、含有组氨酸残基(包括聚乙二醇化的或大分子单体的形式)的聚组氨酸或肽和/或蛋白质以及其组合。合适的合成胺包括具有伯胺官能性(例如,丙烯酰胺)的乙烯基单体和其共聚物、赖氨酸改性的聚酯(PLA)、聚乙二醇(PEG)、PEG聚丙二醇、PEG-共-硅酮以及其组合。其他合适的多官能团胺包括以上列举的化合物。
另外的合适的第一或第二反应组分包括含有琥珀酰亚胺基的功能高分子的材料,例如N-羟基琥珀酰亚胺酯(NHS)、N-羟基磺基琥珀酰亚胺酯(SNHS)、N-羟乙氧基化的琥珀酰亚胺酯(ENHS)以及其组合。基于琥珀酰亚胺基的酯对上述多官能团伯胺具有反应性。一般来讲,应该理解如果伤口闭合装置包含NHS酯反应基团,第二互补反应基团包含存在于表面的多官能团伯胺。
在进一步的实施方式中,第一或第二反应组分可以包含亲电子官能团,而互补的第二或第一组分可包含亲核官能团。亲电子官能团包括上述列举的含有琥珀酰亚胺基的聚合物如SNHS和ENHS。亲电子基团的另外的非限制性实例包括羰基咪唑、异氰酸酯、乙烯基砜、马来酰亚胺和对硝基苯。除了巯基以外,合适的亲核官能团包括天然的以及合成的多官能团伯胺,例如上述列举的化合物。其他合适的第一和第二亲核以及亲电子反应组分以及制备方法公开在美国专利6,887,974;7,332,566;6,566,406;7,009,034;6,165,201;6,818,018和于2008年7月8日提交的美国专利申请61/078,968中,其主题在此引入作为参考。
用于形成本公开的水凝胶的第一和第二反应组分可具有生物相容性和水溶性的核基团。这里使用的“水溶性”是指在水中的溶解度至少为大约1g/l。该核基团可为最少具有三个臂(three arms)的水溶性分子。核基团的臂是指将可交联官能团连接到多官能团中心从而引发聚合臂的聚合反应的化学基团的线性链。所述多官能团中心和附着臂的结合可形成核基团。
在实施方式中,所述核基团可为水溶性聚合物。可使用的该种聚合物的实例包括,例如:聚醚,例如,聚环氧烷,如聚乙二醇(“PEG”)、聚环氧乙烷(“PEO”)、聚环氧乙烷-共-聚环氧丙烷(“PPO”)、共聚环氧乙烷嵌段或无规共聚物;乙烯基聚合物,如聚乙烯醇(“PVA”)、聚乙烯基吡咯烷酮(“PVP”);蛋白质,如聚氨基酸;多糖,如葡聚糖,以及上述聚合物的衍生物和其组合。
在其他实施方式中,多官能团中心可包含多元醇,在实施方式中该多元醇可具有用于引发能形成核的臂的单体基团的羟基,该核然后可与可交联基团进行官能作用。根据所需要的臂的数目,多元醇可具有大约3~大约12个羟基,在实施方式中为大约4~大约10个羟基。多元醇也可具有其他的保护的或未保护的官能团。合适的多元醇包括甘油、甘露糖醇、还原糖如山梨糖醇、季戊四醇,和包括六甘油的甘油低聚物,以及其衍生物和其组合。本领域技术人员会很容易明白,羟基的数目应该相当于多臂核上的臂的数目,即,选择的特定的多元醇应该决定生成的多官能团核基团上的臂的数目。在实施方式中,上述的聚合物,例如聚乙二醇,可通过引发环氧乙烷和多元醇的聚合来形成,由此形成多臂核的臂,该多臂核可进一步与反应组分进行官能作用。
因此水凝胶可由具有第一组官能团的多臂核和具有第二组官能团的低分子量聚合物来制备。多臂核上的臂的数目可为约3~约12,在实施方式中为约5~约10。
例如,多臂核可具有亲水性臂,例如,末端为N-羟基琥珀酰亚胺(反应组分)的聚乙二醇,臂的合并的分子量为大约1,000~大约40,000;技术人员会立刻明白在明确表述的界限内的所有范围和数值是经慎重考虑的。在一些实施方式中,可能需要使用具有六个臂或八个臂的多臂核。单个臂的分子量可为大约250~大约5000,在实施方式中,为大约1000~大约3000,在其他实施方式中为大约1250~大约2500。
在一些实施方式中,六臂或八臂聚合物核可与作为第一反应组分的低分子量聚合物(例如三赖氨酸)反应。该三赖氨酸提供多个用于交联第二反应组分反应点并且它可能(不限于特定的作用理论)在收缩或膨胀方面允许相对较小的移动,这种移动可能与相对较大并且更易活动的多臂核有关。因此,可使用其他小分子来代替三赖氨酸,例如,分子量为大约100~大约5000的分子,在实施方式中为大约300~大约2500,在其他实施方式中为大约500~大约1500。这些小分子可具有至少约三个官能团,在实施方式中为约3~约16个官能团;普通技术人员应该理解在这些明确表述的数值内的所有范围和数值是是经慎重考虑的。在某些情况下可使用二赖氨酸和/或四赖氨酸作为低分子量前体。
在一些实施方式中,自封闭装置可另外包括pH活化剂。pH活化剂在暴露于含水的环境后会使pH产生局部变化以加速或引发水凝胶的形成。例如,pH活化剂可包括固体硼酸盐晶体,如Na2B4O7·10H2O,但也可使用其它的盐基材料或别的材料。可供选择地,可使用例如,硼酸钠和碳酸氢钠等的pH改变剂。可使用多种方法将pH活化剂/改变剂加入到装置中,这些方法包括但不限于涂敷法、复合在装置中、涂覆作为粘合剂层、沿装置施加局部储存库等。
图7A-7B图示了本公开的两种实施方式,两种组分已经反应产生了自封闭装置。更具体地讲,图7A图示了含有第一反应组分的伤口闭合装置50(吻合钉),射入经过包含第二反应组分的加固材料60中。图7A图示了自封闭装置的一种实施方式,导致在吻合钉50和支撑件60之间形成水凝胶70。一旦两种反应组分被混合,在第一和第二反应组分发生物理接触的邻近区域中就形成交联结构。该新的交联结构可通过形成的水凝胶的存在来示例。在一些实施方式中在衰弱的或损坏的组织中,水凝胶70会封闭周围区域中的任何剩余空间。另外,水凝胶可为空间填充物并可以通过调整以使在特定位置优先地膨胀。例如,与8-臂的PEG水凝胶(显示较小的膨胀)相比,具有较大膨胀特性的水凝胶,例如4-臂的PEG水凝胶,可以优先地设置在自封闭装置中以吸收增加的液体。随着时间推移,水凝胶会吸收周围组织中的另外的液体。
图7B图示了另一种实施方式,其中吻合钉腿100a显示出比支撑件120更加膨胀。在这两种实施方式中,水凝胶形成在与吻合钉腿最接近的并大体与之同心的区域,并且会在吻合钉腿和加固材料的界面重叠。根据选择的用于第一和第二反应组分的材料,或者加固材料或者伤口闭合装置会显示出不同的和变化程度的膨胀(包括负膨胀)或液体吸收。具有不同的或变化程度的膨胀的材料的实例公开在于2007年3月5日提交的美国临时专利申请11/714,028中,其全部公开内容在此引入作为参考。例如,内部的或近侧的吻合钉排会比外部的或远侧的吻合钉排更加膨胀,在更接近伤口的地方更加起到止血作用。也可以预想到加固材料在某些位置会优先地膨胀。
如图7A-7B所示,(第一反应组分和第二反应组分的)化学反应包括水凝胶的形成。其中使用的术语水凝胶包括吸收溶剂(例如水)、进行快速的膨胀而没有明显的溶解并且保持能进行可逆变形的三维网状结构的材料。水凝胶传统上为水膨胀的交联的聚合物结构,该结构或者包括共价键、离子交联、缠结的物理交联、缔合结合(如氢键结合或强范德华相互作用),或者包括两个或多个高分子链的微晶。交联表示在水凝胶结构内可为碳原子的结合点,但交联也可为小的化学桥。交联也可为由于范德华力或水凝胶键形成的凝聚体的高分子链的缔合。水凝胶也包括可为永久或半永久的物理缠结的交联,或形成微晶的有序的链。
水凝胶可为均聚物水凝胶、共聚物水凝胶(通过两种或更多种单体单元的交联来制备,其中一种单体单元必须为亲水性的)、多聚物水凝胶(通过三种或更多种共聚单体来制备)、或互穿聚合物水凝胶(通过制备第一网络结构然后将其在单体中膨胀的方法来制备)(生物材料科学(Biomaterial Science)2ndedition,2004,100-107页)。
在本公开的一些实施方式中,可以使用构成“智能水凝胶(smart hydrogels)”的材料。智能水凝胶包括根据外部环境(例如身体)来决定其膨胀行为的材料。例如,水凝胶可根据包括但不限于pH、温度、离子强度、酶或化学反应、和电或磁的刺激的因素进行膨胀(或收缩)。智能水凝胶对刺激的快速反应能力很容易地使水凝胶在药物递送方面得到应用。
在另外的实施方式中,第一反应组分可以以在装置上确定的储存库或引入到装置的间隙中的方式存在以使其选择性地与第二互补反应组分反应。如图8所示,编织网200包含沿网表面存在于确定的间隙210中的第一反应组分,例如,琥珀酰亚胺基官能团。琥珀酰基亚胺基官能团可被编织在网中、沉积在网的特定的间隙中或被引入其中。与网200相互作用的大头钉300上涂敷有第二反应组分,例如赖氨酸残基。当大头钉300被射入通过网200时,其使网200固定到组织400上,第一反应组分和第二反应组分相互作用,沿着网200产生封闭区域,这有助于将网200固定在适当的位置。
在另一个实施例中,加固材料或伤口闭合装置可包含填充有特定的反应基团的储存库(depot)或储存池(reservoir)。例如,可以使用微粒涂层形成储存池或者在自封闭植入体的表面上形成含有浓缩量的反应组分的区域。在另一个实施例中,可以通过在装置内制造出空隙或空白空间,然后可在空隙或空白空间中填入反应组分来产生储存库。该空隙可为开孔或闭孔格栅结构。制造方法包括例如机械切割(如激光切割)、冻干、微粒沥滤、压膜、析相、气体起泡(例如,内发泡剂,如CO2)的方法,或使用成孔剂(porogen)(例如,盐粒子)。可以使用例如注塑或包括上述列举的标准涂敷技术的方法将反应组分填充到空隙中。
本公开的自封闭植入体既包括固体结构又包括多孔结构。多孔结构可为开孔泡沫体或闭孔泡沫体,使用本领域技术人员所熟知的技术制备。多孔结构包括但不限于编织物,例如网、毡、移植物和包括冻干泡沫和支架的泡沫。另外植入体可被构建为至少一层。在一些实施方式中,植入体可包括多层结构,例如泡沫体或膜。多层结构的一个非限制性的例子包括进一步包含抗粘合涂层的编织手术网。在其他实施方式中,本公开的植入体可进一步涂敷涂层来提高例如润滑性、医生操作性、可湿性和组织整合等的性能特性。例如,加固材料可涂敷有水溶性层,例如聚乙烯吡咯烷酮(PVP)。因为PVP能够(在几秒到几分钟内)溶解可以释放到周围区域内的反应组分,所以产生自封闭植入体。
在另一个实施例中,使用涂敷有作为第一反应组分的SNHS酯聚合物的吻合钉可以把胶原支撑件(加固材料)施加到肺组织中。在这个实施方式中,第一反应组分除了与肺组织反应以外还选择性地与胶原支撑件(所述胶原含有多官能团伯胺)相互作用。应该指出的是由于肺组织也包含多官能团伯胺,肺组织也选择性地与吻合钉相互作用。
在以下的描述中,其中使用的术语“可生物降解”定义为包括可生物吸收和生物再吸收的材料。可生物降解,是指所述材料在身体条件下(例如,酶促降解或水解)分解、或失去结构的完整性或在身体中在生理条件下瓦解(物理地或化学地)使得降解产物被身体排泄或吸收。
除了反应组分以外,用于构建自封闭植入体的其他材料可包括可生物降解的材料,例如合成的以及天然的材料。例如,图1所示的加固材料可包括乙交酯、TMC、进一步涂敷有反应组分的二噁烷酮共聚物,应该理解所述加固材料不限于特定的聚合物或共聚物。合适的合成的可生物降解的材料包括例如由丙交酯、乙交酯、己内酯、戊内酯、碳酸酯(例如三亚甲基碳酸酯、四亚甲基碳酸酯等)、二噁烷酮(例如,1,4-二噁烷酮)、δ-戊内酯、二氧杂环庚酮(dioxepanone)(例如1,4-二氧杂环庚-2-酮和1,5-二氧杂环庚-2-酮)、乙二醇、环氧乙烷、酯酰胺、γ-羟基戊酸酯、β-羟基丙酸酯、α-羟基酸、羟基丁酸酯、聚原酸酯、羟基链烷酸酯、酪氨酸碳酸酯、聚酰亚胺碳酸酯、聚亚氨基碳酸酯例如聚(双酚A-亚氨基碳酸酯)和聚(氢醌-亚氨基碳酸酯)、聚氨酯、聚酐、高分子药物(例如,聚二氟苯水杨酸(polydiflunisol)、聚阿司匹林和蛋白质治疗剂)及其共聚物和其组合制备的聚合物。
上面提及的高分子药物可包括其中主链含有高分子药物的聚合物,或可选择地,高分子药物可包括其中侧基或侧链含有高分子药物的聚合物。在一个实施例中,加固材料(例如支撑件)可包含抗炎组合物(如聚阿司匹林)的挤塑薄膜。可降解高分子药物还可包括:包括但不限于聚酐、聚酯、聚醚酯、聚胺、聚酰胺酯以及其组合的聚合物。
也可使用天然聚合物来构建本公开的自封闭植入体,包括但不限于,胶原、聚(氨基酸)、多糖如纤维素(包括羧甲基纤维素)、葡聚糖、壳多糖、壳聚糖、藻酸盐和葡糖胺基聚糖、透明质酸、肠线以及其共聚物和其组合。其中使用的胶原包括天然胶原,例如动物衍生的胶原,或合成的胶原,如重组胶原。本公开也可包括蛋白质,例如弹性蛋白、白蛋白、酪蛋白。另外地,天然材料包括上述列举的材料的化学改性,例如重组、胺化、磺化和羧化的聚合物类似物。
在某些应用中,可优选具有至少一种加固材料和包含不能生物降解材料的伤口闭合装置。在一个非限制性的例子中,可优选具有不能生物降解的伤口闭合装置。合适的材料包括氟化聚合物(例如氟代乙烯、氟代丙烯、氟代PEG)、聚烯烃(例如聚乙烯)、聚酯(例如聚对苯二甲酸乙二酯(PET))、尼龙、聚酰胺、聚氨酯、硅酮、超高分子量聚乙烯(UHMWPE)、聚丁酯、聚乙二醇、聚芳醚酮及其共聚物和其组合。另外地,不能生物降解的聚合物和单体可相互结合并且还可与各种可生物降解聚合物和单体结合以产生自封闭植入体。
在某些实施方式中,根据本公开的自封闭植入体可至少部分地使用形状记忆聚合物来构建。形状记忆聚合物是指具有从变形状态(暂时形状)恢复到其起始状态(永久形状)的能力的智能材料,这种恢复是由于外部刺激(例如温度、电流、光、pH等)引起的。用于制备形状记忆聚合物的硬部分和软部分的合适的聚合物包括聚己酸内酯、二噁烷酮、丙交酯、乙交酯、聚丙烯酸酯、聚酰胺、聚硅氧烷、聚氨酯、聚醚酰胺、聚氨酯/脲、聚醚酯、和氨基甲酸乙酯/丁二烯共聚物及其组合。
在另外的实施方式中,伤口闭合装置(例如吻合钉或缝合线)可至少包含金属或金属合金。合适的金属和金属合金可选自钛、镍钛、钢、镁基合金、锰基合金以及其组合中。本公开的金属或金属合金可另外地具有形状记忆特性,或选择性的可以是可生物降解的。
在一些患病的人群中,某些组织会不如其他组织有弹性。例如,若患者为糖尿病人或曾接受过化疗治疗,他们的组织与健康人的相比弹性较差。组织的弹性反应和加固材料会随着吻合钉的大小、组织特性和所选择的加固材料而变化。小孔会存在于支撑件和潜在地同心围绕吻合钉腿的区域的组织中。本公开的一些实施方式帮助封闭这些小孔,这会防止液体渗漏。本公开的实施方式也会增加组织中加固材料的稳定性。在其他实施方式中,自封闭装置可用作止血钳,促进血液凝固或帮助促进血液分级凝固(clotting cascade)。
可以使用多种方法将第一和第二反应组分涂覆到植入体上或引入其中。在一种实施方式中,伤口闭合材料和/或加固材料可包括以涂层形式存在的反应组分。涂敷医疗植入体的方法为本领域技术人员所熟知并且包括但不限于喷雾法(例如超声波或电喷射)、刷涂法、浸涂法、滴涂法、溶剂蒸发法、激光和喷墨印刷法等。涂层组合物可以为溶液、分散体、乳液或其他任何的均相或异相混合物的形式。另外地,可以使用溶剂将涂层涂覆到植入体上。合适的溶剂为本领域技术人员所熟知的包括极性和非极性的溶剂。
也可以使用其他的方法将第一和第二反应组分引入到所述装置中,例如,反应组分可以被包埋或复合在树脂内。例如,多官能团伯胺可被复合在聚酯内并被挤出(或共挤出)形成植入体(例如纤维)。另外地,该种纤维可以和其他纤维编织或交织形成多丝植入体(例如编织的缝合线或者网)。多个细丝可使用本领域技术人员所熟知的任何技术结合,例如混合、绞合、编织、交织、缠结和针织。例如,多个细丝可简单地结合形成纱。作为另一个实施例,可对多个细丝进行编织。
如上所述,本公开的自封闭植入体包括至少一种加固材料和一种伤口闭合装置。示例性的加固材料包括,但不限于,加固装置如纱布、支撑件、片、支架、带、毡和网(包括生物和合成的网)。本公开的合适的伤口闭合装置包括但不限于吻合钉、缝合线、夹子、大头钉、螺钉、别针、锚、紧固件、护套、分流器、组织屏障、支撑架和移植物。本公开的自封闭植入体可包括包含上述列举的可生物降解的和不能生物降解的材料。
另外地,植入体的任何部分可包含生物学上可接受的添加剂,例如催化剂、缓冲盐、盐、无机填料、增塑剂、抗氧剂、染料、颜料、影像增强剂(MRI,CT,X射线和荧光造影剂)、稀释剂、生物活性剂(如药物和药剂),以及其组合,这些添加剂可以涂敷在植入体上或浸渍在所述材料里。
在一些实施方式中,包含染料或颜料的可视剂可用于提高手术过程中的可视度,包括显影液体流经或环绕装置的情况。可视剂可选自各种适合用于可植入的医疗装置中的任何无毒的有色物质,例如FD&C BLUE(#1,2#,#3和#6)、曙红、亚甲蓝、靛青绿、或通常见于合成缝合线的有色染料。在实施方式中,例如绿色或蓝色的颜色可以是希望的并且在血液存在的条件下或在粉红或白色的组织背景下具有较好的可视度。然而,当下面组织为白色时红色染料是合适的。
可视剂可存在于反应组分中,或另外选择性地被引入加固材料或伤口闭合装置中。有色物质可以或不可以与水凝胶进行化学结合。在实施方式中可视剂可存在的量为小于大约1%重量/体积,在其他实施方式中小于大约0.01%重量/体积,以及在其他实施方式中小于大约0.001%重量/体积浓度。
可引入到植入体中的药剂包括抗微生物剂、抗病毒剂、抗真菌剂等。其中使用的抗微生物剂定义为通过其自身或通过协助身体(免疫系统)来帮助身体消灭或抵抗可致病(引起疾病)的微生物。术语“抗微生物剂”包括抗生素、群体感应阻断剂(quorum sensing blocker)、表面活性剂、金属离子、抗微生物蛋白质和肽、抗微生物多糖、防腐剂、消毒剂、抗病毒剂、抗真菌剂、群体感应阻断剂及其组合。与本公开可以组合的合适的防腐剂和消毒剂的例子包括六氯酚、阳离子双胍(如双氯苯双胍己烷(25chlorohexadine)和cyclohexidine)、碘和碘递体(如聚维酮碘)、卤素取代的酚化合物(如PCMX(例如对氯间二甲酚))、呋喃医用制品(如呋喃妥因(nitrofurantion)和呋喃西林(nitrofurazone))、甲胺、醛(如戊二醛和甲醛)、醇及其组合等。在一些实施方式中,抗微生物剂中的至少一种可为防腐剂,例如三氯生(triclosan)。
可与本公开结合的抗生素的种类包括四环素(如二甲胺四环素)、利福霉素(如利福平)、大环内酯(如红霉素)、盘尼西林(如萘夫西林)、头孢菌素(如头孢唑啉)、β-内酰胺抗生素(如亚胺培南和氨曲南)、氨基糖苷(如庆大霉素和)、氯霉素、磺酰胺(如磺胺甲噁唑)、糖肽(如万古霉素)、喹诺酮(如环丙沙星)、夫西地酸、甲氧苄氨嘧啶、甲硝唑、克林霉素、莫匹罗星、多烯(如两性霉素B)、唑系(如氟康唑)和β-内酰胺抑制剂(如舒巴坦)。可以加入的其他的抗微生物剂包括,例如,抗微生物肽和/或蛋白质、抗微生物多糖、群体感应阻断剂(例如,溴化呋喃酮)、抗病毒剂、金属离子(如离子银和离子银镜)、表面活性剂、化疗剂、端粒末端转移酶抑制剂、包括5-环单体的其他环状单体、米托蒽醌等。
在一些实施方式中,可使用的合适的生物活性剂包括色料、染料、保存剂、蛋白质和肽制剂、抗生素和纳米体、蛋白质治疗剂、多糖(如透明质酸)、外源凝集素、类脂、益生菌(probiotics)、成血管剂、抗血栓形成剂、抗凝血剂、凝血剂、止痛药、麻醉剂、伤口修复剂、化疗剂、生物制剂、抗炎剂、抗增生剂、诊断剂、退热剂、消炎剂和止痛剂、血管扩张剂、抗高血压和抗心律失常剂、降血压剂、止咳剂、抗瘤剂、局部麻醉剂、激素制剂、抗哮喘剂和抗过敏剂、抗组织胺剂、抗凝剂、镇痉药、脑循环和代谢改进剂、抗抑郁药和抗焦虑药、维生素D制剂、降血糖剂、抗溃疡剂、安眠药、抗生素药、抗真菌剂、镇定剂、支气管扩张剂、抗病毒剂、排尿剂、溴化的或卤化的呋喃酮等以及其组合。
在一些实施方式中,可以使用高分子药物(所述化合物的高分子形式例如,高分子抗体、高分子防腐剂、高分子化疗剂、高分子抗增生剂、高分子防腐剂、高分子非甾体抗炎药(NSAIDS)等)和其组合。
在某些实施方式中,本公开的植入体可以含有合适的药剂,如病毒和细胞、肽、多肽和蛋白质、类似物、突变蛋白质,和其活性片段,例如,免疫球蛋白、抗体(单克隆和多克隆)、细胞因子(例如,淋巴因子、单核因子、趋化因子)、凝血因子、造血因子、白细胞介素(IL-2、IL-3、IL-4、IL-6)、干扰素(β-IFN、α-IFN和γ-IFN)、红细胞生成素、核酸酶、肿瘤坏死因子、集落刺激因子(例如,GCSF、GM-CSF、MCSF)、胰岛素、抗肿瘤制剂、肿瘤抑制基因、血蛋白、促性腺激素(例如,FSH、LH、CG等)、激素和激素类似物(例如,生长激素)、疫苗(例如,肿瘤、细菌和病毒抗原)、生长激素抑制素、抗原、凝血因子、生长因子、蛋白抑制剂、蛋白拮抗剂和蛋白激动剂、核酸(例如反义分子、DNA、RNA、寡核苷酸、多核苷酸和核酶)、病毒颗粒及其组合。应该理解可以调整根据本公开的植入体的降解机制以提供特定的释放率,其中某种材料的降解可对应于生物活性剂的流出或释放。
把上述生物活性剂和本公开的各种材料进行结合的方法是本领域的技术人员所熟知的并且包括但不限于混合、掺合、复合、喷雾、芯吸、溶剂蒸发、浸涂、刷涂、蒸汽沉积、共挤、毛细管芯吸、薄膜铸塑、膜塑等。另外地,可以使用溶剂将各种制剂引入到植入体中,合适的溶剂包括但不限于极性或非极性溶剂,例如,醇如甲醇、乙醇、丙醇;氯化烃(例如二氯甲烷、氯仿、1,2-二氯乙烷);和脂族烃(例如己烷、庚烷和乙酸乙酯)。
引入到本公开的植入体上的生物活性剂可具有多种释放特征包括但不限于零顺序、第一顺序、第二顺序释放特征和其组合。对各种材料进行改性使其更具有疏水性或亲水性以获得所需的生物活性剂的释放效果也属于本领域技术人员知晓的范围。如上所述,可以对生物活性剂和各种材料都进行改变来获得特定的释放机制以使与植入体和组织的结合相一致。
一旦构建了植入体,可以使用本领域技术人员所熟知的任何方法进行灭菌,包括但不限于使用环氧乙烷、电子束(e-beam)、γ-辐射、热压灭菌、等离子灭菌等方法。
应该能够理解,可对此处公开的实施方式进行多种修改。因此,以上说明不应认为是限制,而仅仅是优选的实施方式的说明。本领域的技术人员将能够预想到在本公开的范围和实质内的其他修改。这些修改和变化属于下述权利要求的范围。
Claims (24)
1.一种自封闭植入体,其包括:
至少一种伤口闭合装置和加固材料,其中,所述伤口闭合装置包含第一反应组分,并且所述加固材料包含第二互补反应组分。
2.根据权利要求1所述的自封闭植入体,其中,所述伤口闭合装置选自吻合钉、缝合线、夹子、大头钉、螺钉、别针、锚、紧固件、护套、分流器、组织屏障、支撑架和移植物中。
3.根据权利要求1所述的自封闭植入体,其中,所述加固材料选自带、毡、支架、片、纱布、网和支撑件中。
4.根据权利要求1所述的自封闭植入体,其中,所述第一和第二反应组分中的至少一种包含涂层。
5.根据权利要求1所述的自封闭植入体,其中,所述第一和第二反应组分中的至少一种被选择性地沉积在所述伤口闭合装置上。
6.根据权利要求1所述的自封闭植入体,其中,所述第一反应组分选自亲电子官能团和亲核官能团中。
7.根据权利要求1所述的自封闭植入体,其中,所述第一反应组分包含选自含有琥珀酰亚胺基的聚合物和多官能团伯胺中的材料。
8.根据权利要求1所述的自封闭植入体,其中,所述第二反应组分选自亲电子官能团和亲核官能团中。
9.根据权利要求1所述的自封闭植入体,其中,所述第二反应组分包含选自含有琥珀酰亚胺基的聚合物和多官能团伯胺中的材料。
10.根据权利要求1所述的自封闭植入体,其中,该自封闭植入体包含选自聚酯、聚醚酯、聚原酸酯、聚羟基链烷酸酯、聚羟基丁酸酯、聚酐、聚胺、聚酰胺酯、聚碳酸酯、硅酮及其组合中的合成材料。
11.根据权利要求10所述的自封闭植入体,其中,所述聚酯选自聚丙交酯、聚乙交酯、三亚甲基碳酸酯、聚二噁烷酮、聚己内酯、聚丁酯及其组合中。
12.根据权利要求1所述的自封闭植入体,其中,该自封闭植入体包含选自天然胶原、衍生胶原、牛心包、明胶、纤维蛋白、纤维蛋白原、弹性蛋白、角蛋白、白蛋白、羟乙基纤维素、纤维素、氧化纤维素、羟丙基纤维素、羧乙基纤维素、羧甲基纤维素、壳多糖、壳聚糖、酪蛋白、藻酸盐及其组合中的天然材料。
13.根据权利要求1所述的自封闭植入体,其中,该自封闭植入体包含高分子药物。
14.根据权利要求13所述的自封闭植入体,其中,所述高分子药物选自聚酐、聚酯、聚醚酯、聚胺、聚酰胺酯及其组合中。
15.根据权利要求1所述的自封闭植入体,其中,所述第一反应组分与第二反应组分相互作用产生水凝胶。
16.根据权利要求1所述的自封闭植入体,其中,所述第一反应组分与第二反应组分以未反应状态设置在所述伤口闭合装置和加固材料上。
17.根据权利要求1所述的自封闭植入体,其中,所述第一反应组分与第二反应组分以未反应状态设置在所述伤口闭合装置和加固材料中。
18.一种自封闭植入体,其包括:
至少一种吻合钉和支撑件,其中,当所述至少一种吻合钉和支撑件相互作用时,形成水凝胶。
19.根据权利要求18所述的自封闭植入体,其中,所述吻合钉和支撑件中的至少一种进一步包含选自含有琥珀酰亚胺基的聚合物和多官能团伯胺中的材料。
20.根据权利要求18所述的自封闭植入体,其中,该自封闭植入体进一步包含选自亲电子官能团和亲核官能团中的至少一种反应组分。
21.一种包括下列步骤的方法:
在组织上设置包含第一反应组分的支撑件;
从吻合器中发射至少一个包含第二互补反应组分的吻合钉,该至少一个吻合钉与所述支撑件接触;以及
引发化学反应。
22.根据权利要求21所述的方法,其中,或者第一反应组分或者第二互补反应组分包含高分子药物。
23.根据权利要求21所述的方法,其中,或者第一反应组分或者第二互补反应组分包含药剂。
24.一种包括下列步骤的方法:
在组织上设置包含第一反应组分的支撑件;
从吻合器中发射至少一个包含第二互补反应组分的吻合钉,该至少一个吻合钉与所述支撑件接触;以及
形成水凝胶。
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Publication number | Publication date |
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AU2010202510A1 (en) | 2011-01-20 |
JP2011005260A (ja) | 2011-01-13 |
EP2292276A3 (en) | 2013-07-31 |
US9463260B2 (en) | 2016-10-11 |
EP2292276A2 (en) | 2011-03-09 |
EP2292276B1 (en) | 2016-11-23 |
CA2707885A1 (en) | 2010-12-29 |
US20100331880A1 (en) | 2010-12-30 |
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