CN102159139A - 局部施用真空以使细胞死亡和损伤减到最小的心脏组织调节的装置和方法 - Google Patents
局部施用真空以使细胞死亡和损伤减到最小的心脏组织调节的装置和方法 Download PDFInfo
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Abstract
本发明提供了治疗心脏组织以便用局部亚大气压调节缺血性心脏组织以便将细胞死亡和损伤减到最小的方法和装置,包括靠近所述受损心脏组织放置多孔材料,从而提供在所述多孔材料的一个或多个孔隙与所述受损心脏组织之间的气体连通,该多孔材料包括电纺材料、浇铸材料、开孔泡沫和印刷材料中的至少一种;将该多孔材料就地在该受损心脏组织上密封从而提供围绕该受损心脏组织的区域,用于在该受损心脏组织处维持亚大气压,将真空源与该多孔材料以气体连通方式操作性连接用于在该受损心脏组织处产生亚大气压;和起动该真空源,以在该受损心脏组织处提供亚大气压。
Description
Louis C.Argenta
David L.Carroll
James E.Jordan
Nicole H.Levi
Jie Liu
Michael J.Morykwas
William D.Wagner
相关申请
本申请要求2008年8月13日提交的美国临时申请61/088,558和2008年7月18日提交的美国临时申请No.61/081,997的优先权,所述申请的全部内容在这里通过引用而并入。
技术领域
本发明一般性涉及治疗心脏组织的方法和装置,更具体但不仅仅涉及用局部亚大气压调节缺血和再灌注的心脏组织以使细胞死亡和损伤减到最小的方法和装置。
背景技术
当一部分心脏没有接受足够的氧和能量底物以满足其需求时,发生了心肌缺血。这通常是由于动脉粥样硬化斑块或血栓形成导致动脉阻塞而发生的。在心肌梗死中存在损伤区域,其中细胞因为缺少血流而立即死亡。具有其中血流受损的相邻层,其等同于郁积区,并且具有更外周的未受影响区。遗憾的是,梗死的心脏将试图增加挛缩的速率,并且总体地起作用以补偿功能不充分的心脏区域。必然地,在“郁积区”中的这些区域被要求做更多的工作,这将增加施加于它们的能量需求,并将随后导致死亡的进一步进展。如果未治疗,该缺血将导致梗死区的扩展,可能最后透壁延伸穿越心室的厚度。
限制由心肌缺血导致的梗死程度优于改进患者的短期和长期输出。因此,为了抢救该心脏组织,必须进行该组织的及时再灌注(重建冠状动脉血流量)。缺血区内的可抢救的组织的量取决于再灌注的及时性。虽然再灌注通过输送氧和营养物(包括能量底物)而停止该缺血过程,但该过程也快速地启动一系列事件和级联,其恶化损伤,扩展坏死区域超过在单独缺血过程中所遇到的区域。许多的该再灌注损伤似乎是炎症性质的,但不适当地针对宿主组织而非外来物质。能够减轻该再灌注损伤可以抢救最大量的心肌。
再灌注损伤本身表现在许多方面,包括心肌功能障碍(心肌顿抑),心律不齐以及导致致死的再灌注损伤的许多事件。目前,具有有效的药理学疗法来治疗再灌注心律不齐,而心肌顿抑将一般通过本身在给定时间解决,留下致死的再灌注损伤的介质作为逻辑目标以试图保存缺血-再灌注的、但有活力的组织。
具有大量的致死的再灌注损伤的潜在的介质,包括钙超载、氧自由基、渗透梯度的改变(和后续的细胞溶胀)、线粒体渗透性转换孔以及炎症(本身为一组复杂的级联和介质,包括补体激活、白细胞浸润和前炎症性细胞因子和介质)。另外,在心肌缺血-再灌注动物模型中,所有这些现象的选择性抑制的心肌保护效应,包括抗氧化剂、钠-氢交换抑制剂、抗炎剂(包括腺苷、粘附分子抗体和补体抑制物)是已知的。然而,非常少的已经在人临床上证明有任何程度的成功,有可能是由于这些疗法选择性作用于事件级联内的单一点,或非常复杂且多层面的过程的单一侧面。因此,虽然负压(或亚大气压)治疗在受伤皮肤和皮下组织上的应用证明了与传统方法相比治愈率提高(如在美国专利Nos.5645081、5636643、7198046和7216651以及美国公开专利申请Nos.2003/0225347、2004/0039391和2004/0122434,所述专利和申请的内容通过引用并入到本文中),但本领域中对于治疗心肌缺血的器械和方法仍然存在着需求。在这些类型的皮肤伤口和皮下伤口中,丝网/敷料常常可以按常规预定的间隔容易且无侵入性地更换,而不对正愈合的组织产生显著的破坏。然而,在使用技术来治疗其中上面的皮肤完整的组织或器官时,上面的皮肤必须用手术切开,经由上面的组织故意形成伤口以使最初受伤的组织或器官暴露。被切开以暴露受伤组织的上面的最初健康的组织能够缝合,以封闭受伤组织的上部。这使得可以对受伤组织进行负压治疗,以修复伤口上组织。负压敷料和覆盖材料的目前可商购的实施方案不是可生物降解的或可生物再吸收的。这种生物可降解性/生物可再吸收性的缺乏需要重新打开缝合的切口,除去敷料和覆盖材料,放置新的敷料和覆盖材料,并再次缝合封闭的切口。该程序必须重复,直到最初的受伤组织被治愈,伴随着最后一次再打开切口以除去敷料和覆盖材料。每次打开切口以更换或除去敷料和覆盖材料,都增加了该部位感染的风险。
发明内容
本发明涉及通过用亚大气压力(或负压)处理来治疗受损心脏组织,如缺血或早期再灌注期的心肌梗死,的器械和方法。用本发明的器械和方法的治疗可以抢救郁积区的细胞,从而减小梗死的尺寸。这种治疗在不能进行搭桥手术或支架手术的末期心肌病中是特别有效的。在左主动脉病变等情况下,该治疗也会用作在心跳骤停之后用于使心脏静止的ECMO(体外膜式氧合)的辅助。
本发明的示例性的负压治疗器械可以包括用于放置在所要治疗的组织上的真空敷料,例如多孔材料。该真空敷料可以本质是生物可结合的,使得不会需要第二阶段的去除。(在这里使用的术语“生物可结合的”被定义为描述了可以无限期地留在患者中并且能够被重新塑造、再吸收、溶解和/或以其它方式被同化或改性的材料。)本发明的器械还可以包括用于放置在真空敷料上的生物可结合的上层覆盖材料(overlay cover),以形成密封包壳(enclosure),其中可以为真空敷料和所要治疗的组织提供和维持亚大气压力。该上层覆盖材料可以粘附于敷料上,并延伸超过所述真空敷料以允许上层覆盖材料附着于周围的非受损心脏组织。上层覆盖材料本身可以是凝胶状的,以便与心脏轮廓相符,并且可能是充分柔顺的,以免干涉心脏功能。该上层覆盖材料可以用纤维蛋白胶水、微细钉(mini-staples)或缝线固定到心肌上。
在使用时,本发明的器械可以用胸腔镜方式放置在已经梗死的肌肉的区域上和相邻的郁积区上。该器械可以通过在胸腔壁中制作并通过心包穿孔的小的切口放置。该真空敷料在结构上可折叠,使得它能够卷起或折叠,以便小得足以通过胸腔镜管插入。心外膜可以用CO2或类似激光或其它切割工具来穿孔,以便暴露下层的缺血心肌。真空敷料然后可以直接放置在该缺血区域上。上层覆盖材料也可以通过内窥镜方式放置和固定于周围的心脏组织上。然后可以引入真空管,例如小导管,使得真空管的远端与上层覆盖材料下的包壳实现气体连通,以便将亚大气压力供给该包壳和所要治疗的组织。真空管的另一端然后可以处于与真空源气体连通,以产生亚大气压力,且真空源可以被起动,以便供给亚大气压力,进行受损心脏组织的负压治疗。另外,该亚大气压力可以以与心脏速率匹配的速率断续地供给。
本发明还可以提供已经具有心肌细胞死亡的稳定区的心肌梗死的延期治疗。再次,通过内窥镜和胸腔壁中小的切口,可以将生物可结合的真空敷料放置在梗死的区域上。再次,可能需要所牵涉的心肌和相邻的心肌的暴露,并提供CO2或类似切割器械来将心外膜穿孔。该真空敷料可被改性,使得心肌或外周肌肉细胞的网格可以引入其内部。该真空敷料还可以引入小导管,具有能够在后续系列时间下再灌注另外的心肌细胞、多能性祖细胞或外周肌肉细胞的能力。在其中具有接近完全细胞死亡或在受损心脏组织中几乎没有或没有肌细胞收缩的区域中,新的收缩细胞能够被接种,以便替换和修复受损心脏组织的收缩功能。最初,可以使用周围肌肉或由培养物生长的周围肌细胞。这些细胞具有有限生命周期,并且预期随时间流逝会疲劳。该心肌可以在初步治疗的处理时活组织检查,取心肌细胞,并培养,以形成大量的有活力的细胞。采集的心肌细胞可以在培养物中供养,并用于后来定期输注,以便形成会覆盖先前的梗死区域的心肌贴片。还有,可以采集祖细胞,立即灌输到受损心脏组织的区域,或者它们能够在培养物中生长,并周期性地灌注到受损心脏组织的区域,期望它们会发育成为心肌细胞。随着时间推移,引入的细胞将被诱导进行有丝分裂或自我复制,因此增加了心脏的功能物质。渐进地增加会逐渐形成血管的细胞的能力是再生医学中的主要步骤,其中目前仅仅一片细胞能够预计存活。
更具体地说,在其一个方面,本发明提供了使用亚大气压力治疗受损心脏组织的方法。该方法包括放置多孔材料与受损心脏组织直接或间接接触,以便提供在多孔材料的一个或多个孔隙与受损心脏组织之间的气体连通。该多孔材料可以包括电纺材料、浇铸材料、开孔泡沫或印刷材料的至少一种。或者或另外,该多孔材料可以包括生物可结合的材料。该多孔材料可以包括例如胶原,脱乙酰壳多糖,聚己酸内酯,聚乙醇酸,聚乳酸,以及它们的组合。另外,该多孔材料可以是聚乙烯醇泡沫,其可以与受损心脏组织直接接触。
该多孔材料可以就地在受损心脏组织上密封,以提供围绕受损心脏组织的区域,用于在受损心脏组织处保持亚大气压力。该多孔材料可操作性地与真空源连接,用于在受损心脏组织处产生亚大气压,且真空源被起动,以便在受损心脏组织处提供亚大气压。该亚大气压力可以在受损心脏组织处维持足以减轻水肿的时间(因此恢复收缩力和顺应性),降低间隙压力,除去炎症性介质,除去炎症增强剂,调节细胞内介质,提高再灌注和微血管流动,降低微血管堵塞,和/或降低炎性细胞在受损心脏组织内部的保留。正被治疗的心脏组织的微观和宏观变形将增加缺血组织中的新血管的血管发生或形成。这将增加心肌细胞的生存力,最终改进心脏缺血部分的功能。另外,已经存在于心脏中的小动脉的宏观和微观变形将导致它们物理再取向到缺血性组织的区域内,因此提高灌注和最终功能。
例如,该亚大气压力可维持在低于大气压约25-125毫米汞柱。该方法还可以包括将覆盖材料,例如生物可结合的覆盖材料,安置在受损心脏组织上,并将该覆盖材料密封到受损心脏组织附近的组织例如非受损心脏组织上,用于在该受损心脏组织处维持亚大气压。该覆盖材料可以以自粘合片的形式提供,其可以放置在受损心脏组织上。在这种情况下,密封该覆盖材料的步骤可以包括将该自粘合片粘合性密封并粘附于受损心脏组织周围的组织上,以在该片和受损心脏组织周围的组织之间形成密封。
在其另一个方面,本发明提供了治疗受损心脏组织的装置。该装置包括用于治疗受损心脏组织的多孔材料,其具有孔隙结构,经构造以允许在该多孔材料的一个或多个孔与所要治疗的心脏组织之间气体连通。该多孔材料可以包括电纺材料、浇铸材料和印刷材料的至少一种。或者或另外,该多孔材料可以包括生物可结合的材料。在此类情况下,还可能有益的是,该多孔材料以使得多孔材料的外缘会比内部更快地再吸收或降解的这种方式配制。多孔材料的去除(再吸收/降解)的速率能够与新组织的形成速率匹配。控制降解速率或再吸收速率的一种方式是改变引入到多孔材料中的交联的数目。
该装置还可以包括用于产生亚大气压的真空源;该真空源可设置成与多孔材料气体连通,以便将亚大气压分配到心脏组织。该多孔材料可以至少在该多孔材料的选择表面处具有足够小的孔隙以防止组织在其中生长。另外,该多孔材料可以至少在该多孔材料的选择表面处具有小于成纤维细胞和心脏细胞的尺寸的孔尺寸,并且可以在不同于所述选择表面的部位具有大于成纤维细胞和心脏细胞的尺寸的孔尺寸。该多孔材料的孔尺寸可以是足够大的,以允许白蛋白大小的蛋白从其中通过。还有,该多孔材料可以包括被密封以防止亚大气压从其中传输的至少一个表面。该装置还可以包括覆盖材料,例如生物可结合的覆盖材料,经构造以覆盖受损心脏组织以在受损心脏组织处维持该覆盖材料下的亚大气压。
该生物可结合的多孔材料和/或覆盖材料可由合成材料如聚乙醇酸、聚乳酸或聚-o-柠檬酸酯制造,或它们可以由天然分子如胶原、弹性蛋白或蛋白多糖制造。合成分子的组合、天然分子的组合或合成与天然分子的组合可以用于优化多孔材料和覆盖材料的材料性能。
可能用来制造该多孔材料的材料的实例是聚己酸内酯(PCL)。在一种示例性的制剂中,将聚己酸内酯与氯化钠(1份己内酯对10份氯化钠)混合,再投入到足够量的氯仿中,以溶解所述组分。将该溶液倒入适当尺寸和形状的容器中,并将其干燥12小时。氯化钠然后被浸出到水中。
多孔材料的第二种示例性的浇铸制剂是在2%乙酸中的1.33%(重量/体积)脱乙酰壳多糖。将该溶液(20mL)倒入适当尺寸的容器中,并在-70℃冷冻2小时,然后转移到冷冻干燥机中,施加真空24小时。然后,该冷冻干燥的敷料用2.5-5%戊二醛蒸气交联12-24小时。
因此,本发明提供了将病理过程的进展减到最小、将生理性心脏完整性的破坏减到最小并且将对心脏血流和营养的干涉减到最小以及通过血管新生和现有血管的再定位来提高心脏缺血区域的血管再形成的器械和方法。通过减轻心脏性水肿和间隙压力,心脏细胞死亡和损害的风险可减到最小。另外,本发明促进了在受损心脏组织中增强炎症性和病理生理性反应的介质、降解产物和毒素的去除。
附图说明
当结合附图来阅读时,本发明的优选实施方式的上述总结及其下详细说明被最好地理解,其中:
图1示意性地说明了在施加亚大气压之前本发明的装置就地的示例性构型的部分横截面视图;
图2示意地说明了当施加亚大气压时图1的部分横截面视图;
图3示意地说明了在施加亚大气压之后图1的部分横截面视图;
图4示意地表示本发明就地的示例性构型的横截面视图,其中心脏上面的组织围绕管被封闭,以产生能够维持真空的空间,所以不需要上层覆盖材料;
图5示意地表示本发明的装置就地的部分横截面视图,其中该多孔材料和与损伤组织邻近的较小孔隙层以及在该较小孔隙层上方的具有较大孔隙的层层叠;
图6示意地表示本发明的多孔材料的示例性构型的视图,其中仅仅多孔材料的单面是开放而非密封的;
图7示意地表示本发明的示例性构型的横截面视图,其中,上层覆盖材料已经放置在多孔材料上,且潜在的泄漏用纤维蛋白胶水密封;
图8示意地表示本发明的示例性构型的部分横截面视图,其中上层覆盖材料的边缘已经被向下折;
图9示意地表示本发明的示例性构型的横截面视图,其中上层覆盖材料是自粘合的;
图10示意地表示本发明的覆盖材料的示例性构型,其中管穿过该上层覆盖材料;
图11示意地表示附着于上层覆盖材料的真空管的部分横截面视图;
图12示意地表示肾,具有动脉和静脉;
图13示意地表示用于施加亚大气压的开放蛤壳式或双瓣式室;和
图14示意地表示设置在图13的室内的肾。
具体实施方式
现在参考附图,其中,在全文中,类似元件同样地编号,本发明涉及使用亚大气压(或负压)来治疗受损心脏组织的器械和方法,其中“受损”组织被定义为包括受伤、损害或以任何其它方式破坏的组织,例如由于外伤、疾病、感染、手术并发症或其它病理过程造成的损伤。更具体地说,本发明的器械和方法可以进行心肌梗死的治疗。
本发明的亚大气压心脏治疗器械100的示例性构型可以包括用于经由管20将亚大气压供给与受损心脏组织7直接或间接接触设置的多孔材料10,如生物可结合的多孔材料,的真空源30,图1-4。在这里使用的“间接接触”被定义为指布置用于传输亚大气压的中间材料与受损心脏组织7和多孔材料10二者接触。在这方面,该多孔材料10可以被结构化,以便将亚大气压输送和分配到受损心脏组织7。或者,多孔材料10可以由在给予亚大气压治疗之后需要除去的材料构成,这可能需要第二次手术。心脏治疗器械100可以通过将多孔材料10与受损心脏组织7接触来应用于患者,以便提供在多孔材料10的一个或多个孔隙和受损心脏组织7之间的气体连通。管20可以在管20的远端22处连接于多孔材料10,并且多孔材料10可以就地通过缝线8密封在皮肤1和皮下组织2中,以便提供围绕受损心脏组织7的区域,用于维持亚大气压,图4。管20的近端24可以附着于真空源30,以便操作性地将多孔材料10连接于真空源30,用于在起动真空源30时在受损心脏组织7处产生亚大气压。任选,上层覆盖材料40,例如生物可结合的上层覆盖材料40,可以定位于受损心脏组织7上方,并靠近受损心脏组织7密封,从而在受损心脏组织7处维持亚大气压。
更详细地转向图1-4,本发明的亚大气压心脏治疗器械100的示例性构型在部分横截面中进行了说明,其中多孔材料10与受损心脏组织7接触。上层覆盖材料40覆盖多孔材料10,且可以扩展到健康的心脏组织6上,产生封闭空间48。粘合剂41如纤维蛋白胶水或其它的材料,可可以放置在上层覆盖材料10和健康的心脏组织6之间。该粘合剂41还可以或者另外设置在上层覆盖材料10的周围,以防止漏出,并且还可以设置在其中管从上层覆盖材料10退出的通路(passthrough)52周围,以防止漏出。图1示出了在施加亚大气压之前的器械100。图2示出了正在施加亚大气压时的器械100,当流体和气体从封闭空间48抽出且上层覆盖材料40遵循多孔材料10的形状时,封闭空间48体积减少。图3示出了已经施加亚大气压之后的器械100,其中上层覆盖材料40遵循多孔材料10的形状。
具体地转向图4,本发明的亚大气压心脏治疗器械100的示例性构型在患者体内就地示出,其中周围组织以部分横截面示出。图示的组织包括皮肤1和皮下组织2,肌肉3,骨骼4,心包5,健康的非受损心脏组织6,受损心脏组织7和胸膜组织12。为了提供通向该受损心脏组织7的通路,一部分心包5可以由于手术切开或损伤而失去。多孔材料10,例如开孔胶原材料,可以放置在皮下空间中与待用亚大气压处理的心脏组织7接触(直接或间接),以便降低水肿和间隙压力、氧自由基、炎症性介质和可能不利影响受损心脏组织内部的细胞复苏或成活力的其它分子,以改进例如生理功能。管20的远端22可以连接于多孔材料10,且管20可以通过切口从身体退出。管20可以在管20的与多孔材料10接触的部分上具有一个或多个开窗23,图6。在心脏组织7直到并包括皮肤1之间的组织例如用缝线8封闭,以产生能够维持真空的气密封。当施加亚大气压时,切开的组织1-5的边缘被吸在一起,并且胸膜组织12被吸向该多孔材料,以有助于维持真空。管24的近端可连接于真空源30,亚大气压的水平通过控制器32控制。该真空源30可以包括罐以收集任何除去的流体。
覆盖材料40可以用于进一步限制围绕受损心脏组织7的区域,在所述区域处维持亚大气压。即,如在图1-3、7-9中所示,覆盖材料40、50提供了在覆盖材料40、50下围绕受损心脏组织7的封闭空间/区域48、58,其可以用于分隔覆盖材料40、50之外的组织,而不暴露于施加于受损心脏组织7的亚大气压。相反,如在图4中所示,在缺乏上层覆盖材料的情况下,输送到多孔材料10和受损心脏组织7的亚大气压可以将周围组织,例如心包5和胸膜组织12沿着图4中所示的箭头的方向向内吸向管20和多孔材料10。在这方面,该拉伸和/或移动的组织如心包5和胸膜组织12可以有助于将所施加的亚大气压限制在心包5和受损心脏组织7之间的区域中。另外,覆盖材料40、50可以进一步保护受损心脏组织7不受外源性感染和污染,超过了已经由多孔材料10和缝合的皮肤1和皮下组织2所提供的保护。同样地,覆盖材料40、50可以进一步保护受损心脏组织7以免来自周围组织(例如心脏脓肿和纵隔炎)的感染的蔓延。
为了有助于在受损心脏组织7处维持亚大气压,可以在受损心脏组织7上提供柔性上层覆盖材料40(图7)或自粘合性柔性上层覆盖材料50(图9),从而提供其中可以维持亚大气压的围绕受损心脏组织7的区域48、58,图7、8。具体地,参考图7、8和9,可以通过将覆盖材料40、50粘附于靠近受损心脏组织7的心脏组织上,以限定围绕受损心脏组织7和多孔材料10的封闭区域48、58,从而在受损心脏组织7和多孔材料10上提供上层覆盖材料40、50。例如,覆盖材料40可使用粘合剂41如纤维蛋白胶水胶合到心脏组织。该粘合剂41可以包括自聚合胶水和/或可以理想地包括填料以便提供具有足够体积的粘合剂41,从而允许粘合剂41遵循粘合剂41接触的潜在不规则表面的形状。该粘合剂41可作为独立组分或作为覆盖材料40的一部分提供。对于柔性上层覆盖材料40,柔性上层覆盖材料40的外缘或边缘可以从非受损心脏组织6滚走(或平坦地放置在非受损心脏组织6上)或滚动到受损心脏组织7之下(或向受损心脏组织7滚动),图7,8。该粘合剂41可放置在上层覆盖材料40的边缘和健康心脏组织6之间,以促进气密封。该粘合剂41还可以设置在管20的周围,在该处它通过上层覆盖材料40退出。或者,自粘合性柔性上层覆盖材料50可以远离受损心脏组织7向外卷曲,使得覆盖材料50的下侧(即,面向多孔材料10的那一侧)然后可以与周围的非受损心脏组织6接触,图9。
除了开孔胶原材料以外,多孔材料10还可以包括聚乙醇酸和/或聚乳酸材料,合成聚合物,柔性片状网、开孔聚合物泡沫,泡沫切片(foam section),多孔片、聚乙烯醇泡沫,聚乙烯和/或聚酯材料,或可通过例如电纺、浇铸或印刷制造的其它适合的材料。这种材料包括可倒入适当尺寸的模具中的脱乙酰壳多糖溶液(1.33%重量/体积,在2%乙酸中,20mL总体积)。然后,将该溶液在-70℃冷冻2小时,然后转移到冷冻干燥机中,施加真空24小时。该敷料可以用2.5%-5%戊二醛蒸气交联12-24小时,以提供浇铸的多孔材料。
另外,该多孔材料10可以通过浇铸聚己酸内酯(PCL)来制备。聚己酸内酯可与氯化钠(1份己内酯对10份氯化钠)混合,再投入到足够量体积的氯仿中,以溶解所述组分。可以将所需量例如8mL的溶液倒入适当尺寸和形状的容器中,并干燥12小时。氯化钠然后可以在水中浸出24小时。
上层覆盖材料40还可以是生物可结合的,并且可以由I型胶原和聚1,8-辛二醇柠檬酸酯(POC)(80%∶20%重量/重量)的电纺混合物组成。溶液浓度可以为在六氟-2-丙醇(hexafluoro-2-proponal,HFP)中的15%,具有9.5mL的总体积。该溶液然后可以从注射器通过18号针头以1-3ml/h的流速射出。电压可以是25kV,工作距离为20-25cm。膜然后可以在80℃热聚合48小时(90℃96小时),并在2.5%-10%戊二醛蒸气中交联24小时。
还可以使用电纺原料用于多孔材料10和使用浇铸材料用于上层覆盖材料40。电纺多孔材料10的制造配方和方法的一个实例是按重量计比率为76%∶4%∶20%的I型胶原∶6-硫酸软骨素(CS)∶聚1,8-辛二醇柠柠檬酸酯(POC)的组合。使用两种溶剂用于胶原/CS/POC。将CS溶于水,并将胶原和POC溶于2,2,2-三氟乙醇(TFE)中。然后使用20%水/80%TFE溶液(体积/体积)溶液。对于电纺,将含有胶原∶CS∶POC混合物的溶液投入到装配18Ga针头的3mL注射器。使用注射器泵(New Era Pump Systems,Wantaugh,NY)以2.0ml/hr的速率将溶液注入针尖。通过高压电源(HV Power Supply,Gamma High Voltage Research,Ormond Beach.FL)提供10-20kV的电压,并在具有15-25cm距离的针(阳极)和接地集电极(阴极)之间施加。该敷料然后用戊二醛(II级,25%溶液)交联,并加热聚合(80℃)达48小时。还可以从起始浓度80mg/ml的在1,1,1,3,3,3-六氟-2-丙醇(HFP)中的胶原开始将I型胶原敷料电纺,然后使用与胶原∶CS∶POC组合同样的电纺条件。
浇铸上层覆盖材料配方的实例包括使用1,8聚(辛二醇)柠檬酸酯(POC)或其它二醇柠檬酸酯的组合,其可以例如是1,6-己二醇或1,10癸二醇。为了制造浇铸上层覆盖材料40,可以将等摩尔量的无水柠檬酸和选择的二醇在圆底烧瓶内合并。(例如:38.4g柠檬酸和29.2g辛二醇)。可以将该溶液在165℃的油浴中加热10分钟,直到熔融,然后继续在140℃加热45分钟。该聚合物可以该形式使用,但也存在未反应的单体。为了除去未反应的单体,可以将等体积量的聚合物和100%丙酮加入到烧瓶内,并振荡,直到聚合物完全溶解为止,然后倒入适当形状的模具内。可以在化学通风橱中在室温下将丙酮蒸发过夜。可以将该膜在80℃聚合36小时,然后在110℃聚合18小时。
或者,为了浇铸脱乙酰壳多糖的上层覆盖材料40,可以将2%乙酸在水中的溶液加入到1%脱乙酰壳多糖重量/体积中。(例如,可以将400μl乙酸加入到20ml水中,然后添加200mg脱乙酰壳多糖。)膜可以通过将该混合物直接倒入模具内并使溶液干燥过夜来制备。溶于氯仿的聚L(乳酸)或聚D,L(乙醇酸-乳酸)的浇铸上层覆盖材料40还可以通过将溶液注入模具内并蒸发掉溶剂(氯仿)来制备。
产生多孔材料10和上层覆盖材料40的另外方法是使用热喷墨印刷技术。可以印刷生物可结合的材料如胶原,弹性蛋白,透明质酸,海藻酸盐和聚乳酸/聚乙醇酸共聚物。例如,可以印刷溶于0.05%乙酸,然后在水中稀释至1mg/ml的I型胶原(Elastin Products Co.,Owensville,MO),也可以印刷在水中的1mg/ml的海藻酸钠(Dharma Trading Co.,San Raphael,CA)。还可以印刷I型胶原(2.86mg/ml,在0.05%乙酸中)和聚乳酸/聚乙醇酸(PURAC America,Blair,NE)(14.29mg/ml,在四甘醇(Sigma Aldrich,St.Louis MO)中)的混合物。可以将Hewlett Packard 660c打印机的硬件连接于其高度可以调整以便层状印刷的平台上。对硬件进行最小的改变,并且不需要进行软件改变。
转向图5,多孔材料10可以包括多层,其中最接近受损心脏组织的层112在多孔材料110和受损心脏组织7之间的界面处含有充分小的孔隙,从而防止组织在其中生长,例如孔尺寸小于成纤维细胞和心脏细胞的尺寸。否则,该多孔材料110可以粘附到受损心脏组织7上,能够引起出血或外伤,并且在除去多孔材料110时甚至潜在地引起心室壁的破裂。另外,组织生长到多孔材料110中可以导致最终侵蚀穿过心室壁或胸膜组织,伴随着如果多孔材料110留在患者体内则多孔材料10向这些组织连续运动和摩擦。此外,组织生长到多孔材料110中可以导致在多孔材料内形成不能收缩的疤痕或者多孔材料110内潜在的组织钙化,如果多孔材料110留在患者体内的话。另外,在多孔材料10、110和该受损心脏组织7之间的界面处的孔尺寸可以是充分小的,以避免在受损心脏组织7处过量产生可能干扰心脏生理功能的肉芽或伤疤组织。同时,该多孔材料10、110的孔尺寸可能是足够大的,以允许白蛋白大小的蛋白通过其移动,从而允许除去不希望有的化合物,如介质、降解产物和毒素。
该多孔材料10、110然而可以在多孔材料10、110的内部或在多孔材料10的不与心脏组织7接触的任何其它部位具有更大的孔尺寸(例如大于成纤维细胞和心脏细胞的尺寸)。例如,该多孔材料110可以包括多层结构,具有具有充分小孔尺寸的非向内生长层112,以便为了放置在心脏组织7处防止组织在其中生长,并且可以具有与非向内生长层112接触的具有较大孔尺寸的不同材料的附加层114。
或者,如在图6中所示,该多孔材料210可以在组成和/或形态上是均匀的。在远离与受损心脏组织的界面的位置,该多孔材料210可以具有足够大的孔尺寸,以促进肉芽组织在受损心脏组织周围的空间中的其它组织处形成,例如促进在已经发生心脏破裂的区域中的肉芽组织形成。另外,该多孔材料210可以具有如下构型,其中多孔材料210的一个或多个侧面或表面212被密封,以防止亚大气压通过这种密封表面212传输,同时,具有至少一个表面214,通过该表面214,亚大气压可以被传输。多孔材料210的这种构型可以提供在多孔材料210的一侧上的组织的优先治疗,而不治疗另一侧上的组织。例如,该受损心脏组织可以用多孔材料210的一侧214上的非密封界面治疗。
另外,该多孔材料10可以包括非金属材料,使得多孔材料10在原位时可以进行MRI。该多孔材料10还可以包括充分顺应的材料,使得不干涉心脏功能。同时,该多孔材料10可包括充分坚固的材料,使得多孔材料10不塌陷到形成可能干涉心脏功能的心脏组织6、7的牵扯或扭曲。
转向图7,为了将亚大气压输送到多孔材料10以便分布到受损心脏组织7上,管20可以在管20的远端22与多孔材料10直接或间接地气体连通。例如,管20的远端22可以包埋到多孔材料10中或者可以放置在多孔材料10上。管20的远端22还可以包括一个或多个开窗23,以便有助于将亚大气压输送到多孔材料10和受损心脏组织7。该管20可以延伸贯穿皮肤1和皮下组织2中的开口,该开口可以围绕管20用缝线8固定,以有助于提供围绕管20的密封。管20的近端24可以操作性地连接于真空源30(例如The V.A.C.,Model 30015B,Kinetic Concepts,Inc.,San Antonio,TX),从而提供亚大气压,该亚大气压经由管20传输到多孔材料10和受损心脏组织7。
该真空源30可以包括控制器32,以调节亚大气压的产生。例如,该真空源30可以经构造以连续地或断续地产生亚大气压;例如,真空源30可以周期性开启和关闭,以提供交替的亚大气压产生和不产生周期。在产生和不产生之间的占空因素可以是1-10(开启/关闭)到10-1(开启/关闭)。另外,间歇的亚大气压可以通过周期的或循环的波形例如正弦波来应用,或者可以在初步治疗之后周期化,以模拟更接近生理的状态,例如心率。该亚大气压也可以根据需要来周期性开启和关闭,通过监测受损心脏组织7中的压力来确定。通常,真空源30可以经构造以输送在大气压和低于大气压200mm Hg之间的亚大气压,以使得如下机会最小化:由于毛细血管和小血管的收缩或由于在受损心脏组织7内充血(血汇聚),亚大气压可能导致局部血流下降;或者亚大气压可能以其它方式对受损心脏组织7有害。这种亚大气压的应用可以用于从受损心脏组织7消除水肿,因此保持心脏功能,从而增加以在生理学上更得到保留的状态得到恢复和存活的概率。
转向图10,亚大气压可以通过在覆盖材料50和管20之间的协同作用在覆盖材料50下输送。具体而言,柔性上层覆盖材料40(或自粘合性柔性上层覆盖材料50)可以包括通路52,通过该通路,管20的远端22穿过,以提供管20和受损心脏组织上方的柔性上层覆盖材料40下方的空间之间的气体连通。
在其另一个方面,本发明也提供使用亚大气压,例如用在图1-4中说明的器械,治疗受损心脏组织的方法。尤其,该方法可以包括布置多孔材料10与受损心脏组织7接近,从而提供在多孔材料10的一个或多个孔和受损心脏组织7之间的气体连通。该多孔材料可以就地靠近受损心脏组织7密封,从而提供围绕受损心脏组织7的区域,用于在受损心脏组织7处保持亚大气压。在这方面,肌肉3和骨4可以宽松地再接近多孔材料10的顶部,其中管20通过皮肤1和皮下组织2退出,皮肤1和皮下组织2缝合闭合。可以任选将另一气密敷料放置在缝合部位上,以促进气密性密封。该多孔材料10可操作性地与真空源30连接,用于在受损心脏组织7处产生亚大气压,且真空源30被起动以便在受损心脏组织7处提供亚大气压。例如,该亚大气压可维持在低于大气压约25到125毫米汞柱。该亚大气压可以在受损心脏组织7处维持足以减低受损心脏组织7处的水肿的时间。另外,该亚大气压可以在受损心脏组织7处维持足以使心脏组织7达到治愈和减少水肿和炎症性介质或增强剂的阶段的时间。该方法可以使用至少2小时,或者能够使用许多天。在真空治疗结束时,可以除去缝线8,将皮肤1、皮下组织2、肌肉3和骨4再打开。该多孔材料10然后可以除去,并将皮肤1、皮下组织2和/或肌肉3再缝合闭合。
该方法还可以包括将上层覆盖材料40、50,例如生物可结合的覆盖材料40、50,放置在该受损心脏组织7上,并将该上层覆盖材料40、50密封到靠近该受损心脏组织7的组织上,用于维持在该受损心脏组织7处的亚大气压。将上层覆盖材料40、50密封到受损心脏组织7周围的组织上的步骤可以包括将上层覆盖材料40、50粘合性密封并粘附到受损心脏组织7周围的组织上。上层覆盖材料50可以以自粘合片50的形式提供,其可以放置在受损心脏组织7上方。在这种情况下,密封上层覆盖材料50的步骤可以包括将自粘合上层覆盖材料50粘合性密封和粘附到受损心脏组织7周围的非受损心脏组织6上,从而在上层覆盖材料50和受损心脏组织7周围的非受损心脏组织6之间形成密封。另外,以气体连通方式将真空源30与多孔材料10操作性连接的步骤可以包括将真空源30连接于管20,管20连接于覆盖材料140的真空端口42,图11。
在本发明的又一个方面,除了损伤的组织和器官以外,该器械和方法还可以用来增加患病或损伤的器官的尺寸和功能。例如,部分功能肾的尺寸可增加到足以返回到正常水平的总过滤能力的尺寸,图12-14,例如剩余的肾301的尺寸增加,如在仅仅具有一个功能肾301的患者中所观察到的。在这样的情况下,具有用于血管蒂的开口305的刚性或半刚性双瓣式包壳(enclosure)304可以放置在肾301周围。当该双瓣式包壳304关闭时,其中两半会合的区域产生了气密密封。该血管蒂通过开口305进入(动脉302)并从(静脉303)离开。纤维蛋白胶水306或其它的生物相容性密封剂可放置在开口305部位处的动脉302和静脉303周围,从而产生气密密封。该包壳304可以包括第二出口305或短接管(nipple)308。管309可以通过第二开口305插入或连接于该短接管308。该管309可以通过该皮肤离开,连接到收集容器,然后连接到真空源。高达125mm Hg亚大气压的控制真空可以断续地施加,其中‘开启’时间至多5分钟,‘关闭’时间至多10分钟。或者,该真空可以周期或循环方式施加,例如正弦波,其中施加真空的较低(最接近大气压)值的绝对值低于舒张压,以允许血液从治疗的器官流出。施加的真空大于(绝对值)舒张压的时间可以多达5分钟,而施加的真空低于(绝对值)舒张压的时间可以多达10分钟。持续实施该技术,直到治疗的器官已经达到所需功能水平或填满该容器。作为另外的例子,该器械和技术可以类似地用于肝叶上或增加胰腺的尺寸。
实施例
实施例1
猪心脏具有类似于人的解剖结构,主要的脉管系统由左冠状动脉和右冠状动脉组成。左主冠状动脉分成冠状动脉回旋支和冠状动脉左前降支(LAD)。LAD沿着前隔膜下行,用对角支灌注左心室的前面部分。关于这些研究,使用缺血-再灌注猪模型,包括暂时性结扎LAD的2-3个对角支,以便在心脏的前面部分产生缺血区域。这些冠状动脉被闭锁75分钟,然后再灌注3小时,以便产生缺血/再灌注损伤。该负压治疗仅仅在实验的再灌注阶段中应用,以模拟临床上相关的治疗窗口。
为了开始研究,给动物服用镇静剂,并转运到手术室。前13只动物通过胸廓切开术暴露心脏,所有后续的动物通过胸骨切开术暴露心脏。LAD的2-3个对角支结扎(用缝线闭锁),以便在心脏的前面部分产生缺血区域。这些冠状动脉被闭锁75分钟,然后再灌注3小时,以便产生再灌注损伤。该负压治疗仅仅在实验的再灌注阶段中应用,以模拟临床上相关的治疗窗口。五只对照动物由研究的前13只动物产生。
在成功完成验证研究设计的对照动物之后,后续5只成功的(胸骨切开术)动物在再灌注期间对心脏缺血区域进行3小时负压治疗处理。对于前5只成功处理的动物,真空敷料包括使用聚乙烯醇多孔材料(Versafoam,KCI,San Antonio TX),切削至大约1mm厚度并修剪以匹配该缺血区域。将排空管包埋到多孔材料中的狭缝切口(2只动物)内,或者缝合到多孔材料的外表面上(3只动物)。该真空敷料然后用生物来源的上层覆盖材料覆盖。这些生物覆盖材料包括:1只动物用E·ZDERMTM(无穿孔猪生物合成伤口敷料,Brennen Medical,St.Paul,MN)处理;1只动物用牛心包膜处理;以及3只动物用AlloDerm(人真皮)(LifeCell)处理。上层覆盖材料通过三种方式附着于心脏上:缝线,纤维蛋白胶水以及由于围绕真空敷料边缘的覆盖材料的相对大的围裙产生的自密封。排空管从上层覆盖材料的‘围裙’边缘的下面引出。该纤维蛋白胶水与缝合以及用于自密封应用的点密封(在其中排空管引出的皱纹处等)结合使用。在再灌注期间使用The V.A.C.,Model 30015B,Kinetic Concepts,Inc.,San Antonio,TX施加125mm Hg的负压(即在低于大气压125mm Hg)达3小时。
为了测定缺血/再灌注的影响,在3小时再灌注周期的结束时再系上缝线。将蓝色染料(专利蓝,Sigma-Aldrich Inc,St.Louis,MO)注入到右心房。这将正常灌注的心脏区域染色。将左心室切割,与剩余心脏分开,并称重(表中的LV)。进一步从左心室切割缺血区域(非蓝色区域)。然后将左心室的蓝色区域称重(表中的蓝色)。然后用染料(氯化2,3,5-三苯基四唑Sigma-Aldrich Inc.,St Louis MO)将缺血区域(非蓝色组织)染色,所述染料将活细胞染成红色。从缺血区域中切割出红色区域,并称重(表中的红色),留下苍白色的坏死组织区域(坏死区域-表中的AN),并将这些苍白色组织样本称重(表中的苍白色)。组合的红色和苍白色的区域构成了危险区域(表中的AAR)。AN/AAR是梗死的尺寸(在缺血/再灌注周期期间死亡的组织的百分率)。
5只对照动物的结果是:
表1.对照动物
5只治疗的动物的结果是:
表2.-125mm Hg治疗的动物
因此,针对对照动物和治疗的动物的梗死的平均尺寸(AN/AAR;在缺血/再灌注周期中死亡的组织的百分率)是:
对照 26.43+/-2.12%(平均值+/-SEM)(n=5)
治疗的 11.87+/-1.24%(平均值+/-SEM)(n=5),
其中,梗死尺寸的T检验结果为P<0.001,危险区域P<0.625。
实施例2
另一实验使用50mm Hg真空进行治疗,与来自以上实施例1的最初对照动物比较。在本实验中的手术技术类似于用于实施例1的技术。给这些动物服用镇静剂,并准备用于进行手术。心脏通过中间线胸骨切开术来暴露。左前降支动脉的分支结扎75分钟。将聚乙烯醇真空敷料放置在缺血区域上,将AlloDerm覆盖材料放置在真空敷料上,并用缝线和纤维蛋白胶水的组合密封就位。施加50mmHg的负压达3小时。在该时间的末尾,将心脏的危险区域染色,除去,然后对坏死区域进行对比染色。这5只50mmHg负压治疗动物的梗死面积结果比对照动物明显更小(p<0.001)。50mm Hg治疗的动物的梗死尺寸小于125mm Hg治疗的动物的梗死尺寸,但不是明显更小。
**p<0.001,与对照动物比较
所有三组(对照,-125mm Hg,-50mm Hg)中动物的平均动脉压和心率在这些实验的过程中是相当的。
将15微米中子激活的微球(BioPAL,,Inc,Worcester,MA)在基线时、缺血末尾、再灌注30分钟和再灌注180分钟(实验结束)时注入到左心房。以7mL/分钟的速率从股动脉同时抽取参考动脉血样本达90秒钟。在梗死尺寸测定工序之后,收集来自非缺血区域(蓝色组织)、缺血非坏死区域(红色组织)和缺血坏死区域(苍白色组织)的组织样本,并送到厂家进行血流分析(BioPAL,Inc.,Worchester MA)。血流作为[(FR x CPMT)/CPMR)/组织重量(g)计算,其中FR=参考样本流速(7mL/min),CPMT=组织样本中的每分钟计数,CPMR=参考血液样本中每分钟计数。血流以mL/min/克组织报告。
血流分析揭示,两个治疗的组在所有三个区域中具有类似的基线血流。在正常灌注的非缺血区中,血流在整个实验过程中保持相对恒定,没有明显的组或时间相关的差别。(表3)在该缺血非坏死区(红色)和缺血坏死区(苍白色)中,缺血特征在于在所有三个组中血流的相等且几乎完全的损失。这些区也显示出正常反应性充血(再灌注后30分钟),并且在该3小时再灌注时间结束时,恢复的血流接近基线血流水平。(表4)。
基线
在堵塞期间
再灌注30分钟
再灌注180分钟
表3.微球分析的血流(ml/分钟/克组织)
表4.局部心肌血流(mL/min/100g组织)
实施例3
进行后续研究,以检验可再吸收的真空敷料和上层覆盖材料。一只动物服用镇静剂,如上所述准备用于手术,并且心脏通过中线胸骨切开术暴露。LAD的分支结扎90分钟。将该敷料通过冷冻干燥来制备。将脱乙酰壳多糖溶液(1.33%重量/体积,在2%乙酸中,20mL总体积)倒入适当尺寸的模具中。将该溶液在-70℃冷冻2小时,然后转移到冷冻干燥机中达24小时。该敷料用2.5%戊二醛蒸气交联12小时,以提供多孔材料。上层覆盖材料是I型胶原和聚1,8-辛二醇柠檬酸酯(POC)(80%∶20%重量/重量)的电纺混合物。溶液浓度是溶于六氟-2-丙醇(hexafluoro-20proponal,HFIP)中的15%,具有9.5mL的总体积。该溶液从注射器通过18号针头以3ml/h的流速射出。电压是25KV,工作距离为25cm。然后将该膜在80℃加热聚合48小时,在2.5%戊二醛蒸气中交联24小时。上层覆盖材料能够在整个实验期间维持真空。然而,真空敷料由于该材料在真空下的塌陷和流动而没有在整个敷料上均等地分布真空。
实施例4
进行进一步研究以测试上层覆盖材料的变化。三只动物服用镇静剂,心脏通过中间线胸骨切开术暴露。在材料的该研究中没有形成梗死。上层覆盖材料以类似于实施例3的方式形成,但具有变动,包括电压、流速和交联用戊二醛的蒸气的浓度的变化。对于这些动物,该多孔材料真空敷料由80%I型胶原/20%POC的溶液形成,使用在8.5mL HFIP中的12%总浓度。流速是2ml/小时,流体通过18号针头在35kV和25cm的工作距离下射出。膜在80℃加热聚合48小时,然后通过暴露于5%戊二醛蒸气达24小时来交联。将排空管缝合到薄聚乙烯醇敷料。将敷料放置在一部分左心室上,用2-4根缝线缝合就位。将上层覆盖材料放置在敷料上,将纤维蛋白胶水置于上层覆盖材料的边缘周围,以确保真空密封。将50mm Hg连续施加于该敷料。对于两只动物,在大约2.5小时之后发生了小的漏气,尽管努力搜寻所述源,但漏气源没有被确定。漏气源可能是在上层覆盖材料中的皱纹部位,缝合材料的尾部可能在上层覆盖材料中穿刺了孔,在心包囊内收集的流体可能使小部分覆盖材料“漂浮”而离开心脏组织等。对于第三只动物,在研究期间保持负压(应用4小时负压)。
实施例5
使用两只动物来测试该敷料。手术技术类似于以上使用的技术。给这些动物服用镇静剂,准备进行手术,心脏通过中间线胸骨切开术暴露。左前降支动脉的分支结扎75分钟。敷料通过浇铸聚己酸内酯(PCL)来制备。将聚己酸内酯与氯化钠(1份己内酯对10份氯化钠)混合,再投入到足量体积的氯仿中,以溶解所述组分。将8ml的该溶液倒入适当尺寸和形状的容器中,并将其干燥12小时。氯化钠然后可以在水中浸出24小时。将敷料切割为缺血区域的大小。将排空管缝合到敷料上,将该敷料放置在缺血区域上,并缝合就位。在缺血75分钟的结束时,将组织再灌注。敷料用AlloDerm覆盖,纤维蛋白胶水放置在AlloDerm边缘的周围。施加50mmHg的真空达3小时。如在实施例1和2中所述的,在该时间的末尾,将心脏的危险区域染色,除去,然后对坏死区域进行对比染色。对于第一只动物,危险区域(缺血区域,AAR)是相当小的,为左心室(LV)的7.9%。梗死尺寸(坏死面积除以危险区域(AN/AAR×100%)是非常小的,为危险区域的2.6%。对于第二只动物,危险区域是更大的,为14.3%(AAR/LV),而梗死尺寸(AN/AAR)为11.52%。
根据以上说明书,本发明的这些和其它优点对于本领域技术人员来说是显而易见的。因此,本领域技术人员会认识到,在不偏离本发明的宽广的发明构思的情况下可以对上述实施方案进行变化或改造。因此应该理解的是,本发明不限于这里所述的特定实施方案,而是意图包括如在权利要求中所阐述的本发明的范围和主旨内的所有变化和改造。
Claims (102)
1.使用亚大气压治疗受损心脏组织的方法,包括:
i.靠近所述受损心脏组织放置多孔材料,从而提供在所述多孔材料的一个或多个孔隙与所述受损心脏组织之间的气体连通,该多孔材料包括电纺材料、浇铸材料、开孔泡沫和印刷材料中的至少一种;
ii.将该多孔材料就地在该受损心脏组织上密封,从而提供围绕该受损心脏组织的区域,用于在该受损心脏组织处维持亚大气压;
iii.将真空源与该多孔材料以气体连通方式操作性连接,用于在该受损心脏组织处产生亚大气压;和
iv.起动该真空源,以在该受损心脏组织处提供亚大气压。
2.根据权利要求1所述的治疗受损心脏组织的方法,其中该多孔材料包括生物可结合的材料。
3.根据权利要求2所述的治疗受损心脏组织的方法,其中所述敷料的生物结合速率在所述敷料的周边处高于在所述敷料的中心处。
4.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料包括聚乙烯、聚氨酯和/或聚酯材料。
5.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中靠近所述受损心脏组织放置多孔材料的步骤包括放置聚乙烯醇泡沫与所述受损心脏组织直接接触。
6.使用亚大气压治疗受损心脏组织的方法,包括:
i.靠近所述受损心脏组织放置多孔生物可结合的材料,以提供所述多孔材料的一个或多个孔隙和所述受损心脏组织之间的气体连通;
ii.将该多孔材料就地在该受损心脏组织上密封,从而提供围绕该受损心脏组织的区域,用于在该受损心脏组织处维持亚大气压;
iii.将真空源与该多孔材料以气体连通方式操作性连接,用于在该受损心脏组织处产生亚大气压;和
iv.起动该真空源,以在该受损心脏组织处提供亚大气压。
7.根据权利要求6所述的治疗受损心脏组织的方法,其中所述敷料的生物结合速率在所述敷料的周边处高于在所述敷料的中心处。
8.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料包括心肌细胞、外周肌细胞或它们的组合。
9.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中操作性连接真空源的步骤包括在所述真空源和所述多孔材料之间连接管,该管具有与所述多孔材料接触的远端。
10.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中靠近所述受损心脏组织放置多孔材料的步骤包括放置所述多孔材料与所述受损心脏组织直接接触。
11.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料包括开孔泡沫。
12.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中靠近所述受损心脏组织放置多孔材料的步骤包括通过将多孔中间材料安置在所述多孔材料和所述受损心脏组织之间,从而放置该多孔材料与所述受损心脏组织间接接触,其中所述多孔中间材料设置成与所述多孔材料和所述受损心脏组织二者接触。
13.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中就地密封多孔材料的步骤包括将覆盖材料放置在受损心脏组织上并将覆盖材料密封到靠近所述受损心脏组织的心脏组织上,用于在所述受损心脏组织处维持亚大气压。
14.根据权利要求13所述的治疗受损心脏组织的方法,其中所述覆盖材料包括用于从所述真空源接受亚大气压的真空端口,并且其中以气体连通方式操作性将真空源与所述多孔材料连接的步骤包括将所述真空源与所述真空端口连接。
15.根据权利要求13-14的任一项所述的治疗受损心脏组织的方法,其中,将该覆盖材料密封到所述受损心脏组织周围的组织上的步骤包括将所述覆盖材料粘合性密封并粘附到所述受损心脏组织周围的心脏组织上。
16.根据权利要求13-15的任一项所述的治疗受损心脏组织的方法,其中,放置覆盖材料的步骤包括将自粘合片放置在所述受损心脏组织上,且其中密封所述覆盖材料的步骤包括将所述自粘合片粘合性密封并粘附到受损心脏组织周围的心脏组织上,从而形成在所述片和周围心脏组织之间的密封。
17.根据权利要求13-16的任一项所述的治疗受损心脏组织的方法,其中放置覆盖材料的步骤包括将生物可结合的覆盖材料放置在所述受损心脏组织上。
18.根据权利要求13-17的任一项所述的治疗受损心脏组织的方法,其中所述覆盖材料包括电纺材料。
19.根据权利要求13-18的任一项所述的治疗受损心脏组织的方法,其中所述覆盖材料包括浇铸材料。
20.根据权利要求13-19的任一项所述的治疗受损心脏组织的方法,其中所述覆盖材料包括胶原。
21.根据权利要求13-20的任一项所述的治疗受损心脏组织的方法,其中所述覆盖材料包括二醇柠檬酸酯。
22.根据权利要求13-21的任一项所述的治疗受损心脏组织的方法,其中所述覆盖材料包括聚1,8-辛二醇柠檬酸酯。
23.根据权利要求13-23的任一项所述的治疗受损心脏组织的方法,其中所述覆盖材料包括脱乙酰壳多糖。
24.根据权利要求13-24的任一项所述的治疗受损心脏组织的方法,其中所述覆盖材料包括聚乳酸。
25.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,包括在所述受损心脏组织处维持所述亚大气压达足以减轻所述受损心脏组织中的水肿的时间。
26.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,包括在受损心脏组织处维持所述亚大气压达足以减少增强所述受损心脏组织中炎症性和病理生理学反应的介质、降解产物和/或毒素的时间。
27.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,包括在受损心脏组织处维持在低于大气压约25mm Hg的亚大气压。
28.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,包括在受损心脏组织处维持在低于大气压约25mm Hg到125mm Hg的亚大气压。
29.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中放置多孔材料的步骤包括放置具有足够小的孔隙以防止组织在其中向内生长的多孔材料。
30.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中放置多孔材料的步骤包括放置孔尺寸小于成纤维细胞的尺寸的多孔材料。
31.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料包括胶原。
32.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料包括脱乙酰壳多糖。
33.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料包括聚己酸内酯。
34.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料包括聚乙醇酸和/或聚乳酸。
35.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料包括多孔的开孔胶原材料。
36.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料包括多孔合成聚合物材料。
37.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料包括多孔片和柔性片状网中的至少一种。
38.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料包括两个或更多个层,其中最接近所述受损心脏组织的层在所述多孔材料和所述受损心脏组织之间的界面处含有充分小的孔隙,以防止组织在其中生长。
39.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料包括大得足以在所述受损心脏组织周围的空间中的其它组织处促进肉芽组织形成的孔尺寸。
40.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料在所述多孔材料和所述受损心脏组织之间的界面处包含充分小的孔隙,以防止组织在其中生长。
41.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料包括足够大的孔尺寸,以允许白蛋白尺寸的蛋白通过其移动,从而能除去不希望有的化合物。
42.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,其中该多孔材料被密封,以防止亚大气压在除了一个以外的所有表面上传输。
43.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,包括将外周肌细胞灌输到该受损心脏组织中。
44.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,包括将心肌细胞灌输到该受损心脏组织中。
45.根据前述权利要求的任一项所述的治疗受损心脏组织的方法,包括将多能性的祖细胞灌输到该受损心脏组织中。
46.用于治疗受损心脏组织的装置,包括:
具有孔隙结构的治疗受损心脏组织用的多孔材料,所述孔隙结构经构造以允许在所述多孔材料的一个或多个孔隙和所要治疗的心脏组织之间的气体连通,该多孔材料包括电纺材料、浇铸材料和印刷材料的至少一种;和
用于产生亚大气压的真空源,其设置成与所述多孔材料气体连通,以便将该亚大气压分布到所要治疗的心脏组织上。
47.根据权利要求46所述的装置,其中该多孔材料包括生物可结合的材料。
48.根据权利要求47所述的装置,其中所述敷料的生物结合速率在所述敷料的周边处高于在所述敷料的中心处。
49.根据权利要求46-48的任一项所述的装置,其中该多孔材料包括聚乙烯、聚氨酯和/或聚酯材料。
50.用于治疗受损心脏组织的装置,包括:
用于治疗受损心脏组织的多孔生物可结合的材料,其具有孔隙结构,其经构造以允许在该多孔材料的一个或多个孔隙与所要治疗的心脏组织之间发生气体连通;和
用于产生亚大气压的真空源,其设置成与所述多孔材料气体连通,以便将该亚大气压分布到所要治疗的心脏组织上。
51.根据权利要求50所述的装置,其中该多孔材料包括开孔泡沫。
52.根据权利要求50或51所述的装置,其中所述敷料的生物结合速率在所述敷料的周边处高于在所述敷料的中心处。
53.根据权利要求46-52的任一项所述的装置,其中在所述多孔材料中包括心肌细胞、外周肌细胞或它们的组合。
54.根据权利要求46-53的任一项所述的装置,包括用于接触该受损心脏组织的多孔中间材料,该多孔中间材料设置在所述多孔材料下方并与所述多孔材料接触。
55.根据权利要求46-54的任一项所述的方法,包括用于布置在所述受损心脏组织上的覆盖材料,用于与靠近所述受损心脏组织的心脏组织密封接合,以便在所述受损心脏组织处维持亚大气压。
56.根据权利要求55所述的装置,其中所述覆盖材料包括设置成与所述真空源气体连通的真空端口,用于从所述真空源接收亚大气压。
57.根据权利要求55-56的任一项所述的装置,其中所述覆盖材料包括用于将所述覆盖材料粘附和密封到该受损心脏组织周围的心脏组织上的粘合性密封。
58.根据权利要求55-57的任一项所述的装置,其中所述覆盖材料包括自粘合片。
59.根据权利要求55-58的任一项所述的装置,其中所述覆盖材料包括生物可结合的材料。
60.根据权利要求55-59的任一项所述的装置,其中所述覆盖材料包括电纺材料。
61.根据权利要求55-60的任一项所述的装置,其中所述覆盖材料包括浇铸材料。
62.根据权利要求55-61的任一项所述的装置,其中所述覆盖材料包括电纺材料。
63.根据权利要求55-62的任一项所述的装置,其中所述覆盖材料包括浇铸材料。
64.根据权利要求55-63的任一项所述的装置,其中所述覆盖材料包括胶原。
65.根据权利要求55-64的任一项所述的装置,其中所述覆盖材料包括二醇柠檬酸酯。
66.根据权利要求55-65的任一项所述的装置,其中所述覆盖材料包括聚1,8-辛二醇柠檬酸酯。
67.根据权利要求55-66的任一项所述的装置,其中所述覆盖材料包括脱乙酰壳多糖。
68.根据权利要求55-67的任一项所述的装置,其中所述覆盖材料包括聚乳酸。
69.根据权利要求46-68的任一项所述的装置,其中该真空源经构造以在所述受损心脏组织处维持低于大气压约50mm Hg的亚大气压。
70.根据权利要求46-69的任一项所述的装置,其中该真空源经构造以在所述受损心脏组织处维持低于大气压约50mm Hg到125mm Hg的亚大气压。
71.根据权利要求46-70的任一项所述的装置,其中该多孔材料包括足够小以防止组织在其中向内生长的孔隙。
72.根据权利要求46-71的任一项所述的装置,其中该多孔材料包括小于成纤维细胞的尺寸的孔尺寸。
73.根据权利要求46-72的任一项所述的装置,其中该多孔材料包括胶原。
74.根据权利要求46-73的任一项所述的装置,其中该多孔材料包括脱乙酰壳多糖。
75.根据权利要求46-74的任一项所述的装置,其中该多孔材料包括聚己酸内酯。
76.根据权利要求46-75的任一项所述的装置,其中该多孔材料包括聚乙醇酸和/或聚乳酸。
77.根据权利要求46-76的任一项所述的装置,其中该多孔材料包括多孔的开孔胶原材料。
78.根据权利要求46-77的任一项所述的装置,其中该多孔材料包括多孔合成聚合物材料。
79.根据权利要求46-78的任一项所述的装置,其中该多孔材料包括多孔片和柔性片状网的至少一种。
80.根据权利要求46-79的任一项所述的装置,其中该多孔材料包括两个或更多个层,其中最接近所述受损心脏组织的层在所述多孔材料和所述受损心脏组织之间的界面处含有充分小的孔隙以防止组织在其中生长。
81.根据权利要求46-80的任一项所述的装置,其中该多孔材料包括足够大以促进肉芽组织在所述多孔材料的选择表面处形成的孔尺寸。
82.根据权利要求46-81的任一项所述的装置,其中该多孔材料在与所述受损心脏组织靠近放置的所述多孔材料的表面处包括充分小以防止组织在其中生长的孔隙。
83.根据权利要求46-82的任一项所述的装置,其中该多孔材料包括足够大的孔尺寸,以允许白蛋白尺寸的蛋白通过其移动从而能除去不希望有的化合物。
84.根据权利要求46-83的任一项所述的装置,其中该多孔材料被密封以防止亚大气压通过除了一个以外的所有表面传输。
85.根据权利要求46-84的任一项所述的装置,其中该真空源包括真空泵。
86.用于治疗体内的损伤或患病组织的可降解的或可再吸收的真空设备,包括:
经构造以植入到体内的敷料,该敷料具有经构造以允许亚大气压通过其传输的空隙结构;和
经构造以植入到体内以覆盖和封入所述敷料的生物可结合的覆盖材料,以便在所述敷料周围提供在其中可维持亚大气压的室。
87.根据权利要求86所述的真空设备,其中该敷料包括生物可结合的材料。
88.根据权利要求87所述的真空设备,其中所述敷料的生物结合速率在所述敷料的周边处高于在所述敷料的中心处。
89.根据权利要求86-88的任一项所述的真空设备,其中该敷料包括电纺或浇铸材料或它们的组合。
90.根据权利要求86-89的任一项所述的真空设备,其中该敷料包括合成分子。
91.根据权利要求86-90的任一项所述的真空设备,其中该敷料包括天然分子。
92.根据权利要求86-91的任一项所述的真空设备,其中所述覆盖材料包括电纺或浇铸材料。
93.根据权利要求86-92的任一项所述的真空设备,其中所述覆盖材料包括合成分子。
94.根据权利要求86-93的任一项所述的真空设备,其中所述覆盖材料包括天然分子。
95.根据权利要求86-94的任一项所述的真空设备,包括与所述敷料气体连通的排空管。
96.治疗器官的方法,包括将该器官封入到气密室内,将亚大气压施加于所述器官上并且维持所述亚大气压达足以提高该器官的功能的时间。
97.治疗器官的方法,包括将该器官封入到气密室内,将亚大气压施加于所述器官上并且维持所述亚大气压达足以提高该器官的尺寸的时间。
98.根据权利要求97所述的治疗器官的方法,其中所述室大于所述器官,且其中维持所述亚大气压直到该器官的尺寸增加至填满该室。
99.根据权利要求96或97所述的治疗器官的方法,其中将所述亚大气压断续地施加于该室。
100.根据权利要求96-99的任一项所述的治疗器官的方法,其中所述施加的亚大气压的绝对值大于舒张压的时间低于5分钟。
101.根据权利要求96-100的任一项所述的治疗器官的方法,其中所述施加的亚大气压的绝对值低于舒张压的时间低于十分钟。
102.用于治疗器官的装置,包括经构造以包围并容纳该器官的气密室,操作性连接于该室以便将亚大气压施加于该器官并维持该亚大气压的真空源。
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- 2009-07-16 ES ES09798735.8T patent/ES2633142T3/es active Active
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IL230911A0 (en) | 2014-03-31 |
US10076318B2 (en) | 2018-09-18 |
CA2730362A1 (en) | 2010-01-21 |
US20150164492A1 (en) | 2015-06-18 |
RU2544093C2 (ru) | 2015-03-10 |
JP2011528577A (ja) | 2011-11-24 |
US20190000433A1 (en) | 2019-01-03 |
IL210724A (en) | 2014-02-27 |
EP2313008A4 (en) | 2015-10-07 |
WO2010009294A1 (en) | 2010-01-21 |
EP2313008A1 (en) | 2011-04-27 |
CN104771197A (zh) | 2015-07-15 |
US9289193B2 (en) | 2016-03-22 |
EP2313008B1 (en) | 2017-04-12 |
BRPI0915972A2 (pt) | 2019-02-26 |
CA3004987A1 (en) | 2010-01-21 |
JP2014204972A (ja) | 2014-10-30 |
RU2011105734A (ru) | 2012-08-27 |
JP6100722B2 (ja) | 2017-03-22 |
ES2633142T3 (es) | 2017-09-19 |
CA2730362C (en) | 2018-07-10 |
IL210724A0 (en) | 2011-03-31 |
JP2016005570A (ja) | 2016-01-14 |
US20100121229A1 (en) | 2010-05-13 |
KR20110070976A (ko) | 2011-06-27 |
AU2009270900B2 (en) | 2015-03-26 |
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