CN102264407B - 组织卷绕支架 - Google Patents
组织卷绕支架 Download PDFInfo
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Abstract
公开了用于治疗具有空腔的创伤的装置和系统。装置包括含有支架层和组织层的支架,其中支架层以与组织层流体连通的方式形成层叠物。层叠物被卷绕成具有两个端面的大体上圆柱形形状。装置还包括歧管,歧管具有用于耦合于减压的源的口并且被定位为与支架流体连通,以向支架层和创伤提供减压。装置还包括盖布,盖布由实质上不可渗透的材料形成并且用于覆盖创伤内的支架和歧管。还公开了用于治疗具有空腔的创伤的方法,并且该方法包括将支架层定位为毗邻组织层以按与组织层流体连通的方式形成层叠物,将层叠物卷绕为具有两个端面的大体上圆柱形形状,并且将支架定位在创伤的空腔内以向创伤提供减压。方法还包括将歧管定位为与支架流体连通,以向支架层和创伤提供减压。
Description
相关申请的交叉引用
本申请要求每个于2008年12月31日提交的美国临时申请第61/142,053号和第61/142,065号的优先权。本申请还要求于2009年8月18日提交的美国临时申请第61/234,692号以及于2009年9月1日提交的美国临时申请第61/238,770号的优先权。前述的申请中的每个以其整体以引用方式并入本文。
发明领域
本申请大体上涉及组织工程,并且特别地涉及适合于用作创伤治疗中的支架(scaffold)的装置和系统。
背景
临床研究和实践已经显示,在接近组织部位处提供减压加强和加速组织部位处的新的组织的生长。这种现象的应用有很多,但是减压的应用已经在治疗创伤中特别地成功。这种治疗(在医学界经常被称为“负压创伤疗法”、“减压疗法”或“真空疗法”)提供了很多益处,包括更快的愈合和增加肉芽组织的形成。典型地,减压已经被通过多孔垫或其他歧管工具施加于组织。多孔垫含有能够向组织分布减压并且引导从组织抽出的流体的孔。多孔垫经常被结合入具有其他帮助治疗的部件的敷料(dressing)。支架还可以被放置入缺陷中以支持组织向缺陷中的生长。支架通常是生物可吸收的,将新的组织留在其位置中。
用于减压治疗的支架在例如WO08/091521、WO07/092397、WO07/196590、WO07/106594中描述。目前支架的适合性可以根据创伤愈合的知识被评价。对身体组织的伤害导致随愈合的时序阶段做出伤口愈合响应(wound healing response),该愈合的时序阶段包括止血(几秒至几小时)、发炎(几小时至几天)、修复(几天至几周)以及重构(几周至几个月)。考虑到创伤愈合过程的早期阶段,在大多数组织类型中存在高度的同源性。然而,由于包含不同类型的生长因子、细胞因子和细胞,各种组织的愈合阶段随时间推移开始出现差异。由于响应的每个组成部分的时间模式的和响应的每个组成部分之间的相互关系的增强的复杂性,伤口愈合响应的后期阶段取决于前期阶段。
用于帮助受损组织的功能的正常修复、再生和复原的策略已经集中于用于支持和加强在该愈合响应中的特别步骤,特别是其后期的各方面的方法。为了这个目的,生长因子、细胞因子、细胞外基质(ECM)类似物、外生细胞以及各种支架技术已经被单独地或彼此结合地应用。虽然使用这种途径已经实现了某种程度的成功,但是仍然存在某些关键的挑战。一个主要的挑战是,在伤口愈合响应内的每个细胞因子和生长因子的时序与协调的影响使得在适当的时间且以正确的协调模式添加个体外生因子的能力变得复杂。由于外生细胞的潜在的免疫原性以及保持细胞活力方面的难度,外生细胞的引入还面临另外的复杂性。
合成的以及生物的支架已经被用于提供用于加强内源性细胞附接、迁移(migration)和定居(colonization)的立体框架。到目前为止,几乎所有的支架都根据它们可以被制造以根据生物学起作用的思想被设计。然而,传统的支架技术(scaffolding technology)依赖于内源性蛋白、细胞因子、生长因子和细胞的向多孔支架的间隙的被动流入。因此,内源性细胞向支架中的定居被距血管元件的距离限制,血管元件在支架的扩散限制内提供营养支持,而与组织类型无关。此外,支架还可以引起导致延长的修复过程以及在植入物周围形成纤维囊的免疫原性响应或异物响应。概括起来,这些复杂性全部可以导致在植入或损伤部位处的减弱的功能性组织再生。
概述
因此,将是有利的是,提供额外的用于专门的组织的修复和重建的系统。本发明提供了这样的系统。
本文描述的例证性的实施方案的系统、装置和方法提供了通过被植入的支架和歧管对组织修复和再生的主动引导。在一个实施方案中,公开了用于治疗具有空腔的创伤的装置。装置包括含有支架层(scaffold lamina)和组织层(tissue lamina)的支架,其中支架层具有边缘并且以与组织层流体连通的方式形成层叠物(laminate)。层叠物被卷绕为具有两个端面的大体上圆柱形形状。卷绕的支架被定位在创伤的空腔内并且向创伤提供减压。装置还包括歧管,歧管具有用于耦合于减压的源的口并且被定位为与支架流体连通,以向支架层和创伤提供减压。装置还可以包括盖布,盖布由实质上不可渗透的材料形成以覆盖创伤内的支架和歧管,以在歧管提供减压时实质上保持创伤内的减压。减压可以同样地通过闭合创伤或施加部位上的软组织和皮肤而被保持在创伤内。
在该装置中,歧管可以被定位为毗邻支架的端面中的一个,与支架层的边缘中的一个流体连通。
在该装置中,层叠物还可包括所卷绕的层叠物的端部分并且支架层也可包括端部分,并且其中歧管可与支架层的端部分流体连通。
在该装置中,支架层可以由生物惰性材料或生物可吸收材料形成。
在该装置中,支架层可以由泡沫或凝胶材料形成。
在该装置中,支架层可以包含生物活性剂,生物活性剂可以从由抗生素、抗体和生长因子组成的组中选择。
在另一个实施方案中,还公开了用于治疗具有空腔的创伤的方法,并且该方法包括将支架层定位为毗邻组织层以按与组织层流体连通的方式形成层叠物,将层叠物卷绕为具有两个端面的大体上圆柱形形状,并且将支架定位在创伤的空腔内以向创伤提供减压。方法还包括将歧管定位为与支架流体连通以向支架层和创伤提供减压,并且然后使用实质上不可渗透的材料覆盖创伤内的支架和歧管,以在歧管提供减压时维持在创伤内的减压。减压可以同样地通过在闭合创伤或施加部位上的软组织和皮肤而被保持在创伤内。
该方法还可包括:将歧管定位为毗邻支架的端面中的一个,与支架层的边缘流体连通。
该方法还可包括:以与支架层的端部分流体连通毗邻所卷绕的层叠物的端部分的方式定位支架层。
在另一个实施方案中,还公开了一种用于治疗具有空腔的创伤的系统,系统包括:压力源,其用于供应减压;支架,其包括支架层和组织层,支架层具有边缘并且以与组织层流体连通的方式形成层叠物,层叠物被卷绕成具有两个端面的大体上圆柱形形状,支架用于定位在创伤的空腔内并且向创伤提供减压;以及歧管,其与压力源和支架流体连通,以向支架层和创伤提供减压。
该系统还可包括盖布,盖布可由实质上不可渗透的材料形成以覆盖创伤内的支架和歧管,以在歧管提供减压时实质上保持创伤内的减压。
在该系统中,歧管可以被定位为毗邻支架的端面中的一个,与支架层的边缘中的一个流体连通。
在该系统中,层叠物还可包括所卷绕的层叠物的端部分并且支架层也可包括端部分,并且其中歧管可以与支架层的端部分流体连通。
在该系统中,支架层可以由生物惰性材料或生物可吸收材料形成。
在该系统中,支架层可以由泡沫或凝胶材料形成。
在该系统中,支架层可以包含生物活性剂,生物活性剂可以从由抗生素、抗体和生长因子组成的组中选择。
在另一个实施方案中,还公开了一种用于填充组织部位的方法,方法包括:将支架层定位为毗邻组织层,以按与组织层流体连通的方式形成层叠物;将层叠物卷绕成具有两个端面的大体上圆柱形形状;将支架定位在组织部位内以向组织部位提供减压;将歧管定位为与支架流体连通,以向支架层和组织部位提供减压。
该方法还可包括以下步骤:使用实质上不可渗透的材料覆盖创伤内的支架和歧管,以在歧管提供减压时实质上保持组织部位内的减压。
该方法还可包括:将歧管定位为毗邻支架的端面中的一个,与支架层的边缘流体连通。
该方法还可包括:以与支架层的端部分流体连通毗邻所卷绕的层叠物的端部分的方式定位支架层。
参照下文的附图和详细描述,例证性的实施方案的其他目的、特点和优点将变得明显。
附图简述
图1A是用于治疗患者身上的表面创伤的系统的包括复合支架和侧安装歧管(side-mounted manifold)的第一例证性的实施方案的示意性的横截面;
图1B是图1A中的复合支架的在线1B-1B上取的横截面;
图2是用于治疗患者身上的皮下创伤的系统的包括复合支架和侧安装歧管的第二例证性的实施方案的示意性的横截面;
图3是图1和2的复合支架和侧安装歧管的示意性的透视图;
图4是用于治疗患者身上的表面创伤的系统的包括复合支架和端安装歧管(end-mounted manifold)的第三例证性的实施方案的示意性的横截面;
图5是用于治疗患者身上的皮下创伤的系统的包括复合支架和端安装歧管的第四例证性的实施方案的示意性的横截面;
图6是图4和5的复合支架和端安装歧管的示意性的透视图;以及
图7是用于图1A和4中所示的系统的流体控制系统的示意图。
详细描述
在以下的对例证性的实施方案的详细描述中,参照了附图,附图形成例证性的实施方案的一部分。这些实施方案被足够详细地描述以使本领域的技术人员能够实践本发明,并且应当理解,可以利用其他的实施方案并且可以做出逻辑结构的、机械的、电的以及化学的变化而不偏离本发明的精神或范围。为了避免对于使本领域的技术人员能够实践本文描述的实施方案来说不必要的细节,描述可能省略了本领域的技术人员已知的某些信息。因此,以下的详细描述不应以限制的意义理解,并且例证性的实施方案的范围仅被所附的权利要求限定。
如本文所使用的,术语“减压”通常是指小于在正在经受治疗的组织部位处的环境压力的压力。在大多数情况下,这种减压将小于患者所处之处的大气压力。可选择地,减压可以小于与组织部位处的组织相关联的流体静压。虽然可以使用术语“真空”和“负压”来描述被施加于组织部位的压力,但是被施加于组织部位的实际压力可以显著地大于通常与绝对真空相关联的压力。减压可以初始地在组织部位的区域中产生流体流。当组织部位周围的流体静压接近期望的减压时,流可以减弱,并且然后减压被保持。除非另外指明,否则本文声明的压力的值是表压。相似地,对减压的增加的指代典型地是指绝对压力的减少,而减压的减少典型地是指绝对压力的增加。
参照图1A和1B,示出了用于将减压施加在患者的身体中的组织部位处以修复缺陷的减压系统100的第一例证性的实施方案。如本文所使用的,术语“缺陷”是指需要组织修复或填充(bulk)的组织部位。例如,缺陷可以是诸如裂伤、切口、烧伤或溃疡的创伤。缺陷还可以是诱导缺陷,例如被外科医师在不同的健康组织中为了填充组织的目的(例如在整形外科中)作出的切口或穿刺。可以因为根据本发明的装置的植入而被填充的组织部位的实例包括但不限于胸部、臀部、脖颈和面部(例如唇、下颌或面颊)。例如,图1A示出了表面创伤102,表面创伤102在表皮104中具有开口,延伸进入真皮106中并且形成空腔。表面创伤可以延伸至不同的深度,包括进入在真皮106下方的皮下组织(未示出)。参照图2,示出了创伤的另一个实例以及减压系统200。图2中的创伤是皮下创伤202,皮下创伤202在表皮104中具有切开的开口,延伸穿过真皮106进入在皮下组织208内的空腔。减压系统200在其他方面是与图1的减压系统实质上相似的,并且因此对于相同的部件使用与图1中所使用的相同的参考数字。
再次参照图1,并且参照图2,减压系统100包括被定位在表面创伤102上的敷料组件110以及用于向敷料组件110提供减压的减压源112。系统100还包括罐114,罐114具有被容纳在罐114内的过滤器(未示出),罐114通过导管116耦合为与减压源112流体连通。罐114还通过第二导管118和导管连接器119与敷料组件110流体连通。罐114可以是用于过滤或容纳从表面创伤102除去的渗出液和其他流体的流体储藏器或收集构件。在一个实施方案中,罐114和减压源112被集成在单一的壳体结构中。
如本文所使用的,术语“耦合”包括直接耦合或通过另外的物体的间接耦合。术语“耦合”还包括两个或更多个部件,该两个或更多个部件由于部件中的每个从同一片材料形成而彼此连续。此外,术语“耦合”可以包括化学的、机械的、热的或电的耦合。流体耦合意指流体与指定的部分或位置连通。
敷料组件110还包括分布歧管120和盖布(drape)122,分布歧管120适合于被定位在表面创伤102的开口处,盖布122适合于覆盖分布歧管120以保持在盖布122下方的在表面创伤102的空腔内的减压。盖布122包括孔124,导管连接器119延伸穿过孔124以提供在第二导管118和分布歧管120之间的流体连通。盖布122还包括外周部分126,外周部分126延伸超出表面创伤102的开口的周界,外周部分126包括用于将盖布122固定于毗邻表面创伤102的开口的健康组织的粘合剂或粘结剂(未示出)。在一个实施方案中,布置在盖布122上的粘合剂可以用于提供在表皮104和盖布122之间的密封,以保持表面创伤102内的减压。在另一个实施方案中,密封层(未示出),例如水凝胶或其他材料,可以被布置在盖布122和表皮104之间,以补充或代替粘合剂的密封性质。
盖布122可以是任何提供气动密封或流体密封的材料。盖布122可以例如是不可渗透的或半渗透的弹性材料。“弹性的”意指具有弹性体的性质,并且通常是指具有像橡胶一样的性质的聚合材料。更具体地,大多数弹性体具有大于100%的伸长率和相当大的回弹性。材料的回弹性是指材料从弹性变形恢复的能力。弹性体的实例可以包括但不限于天然橡胶、聚异戊二烯、丁苯橡胶、氯丁橡胶、聚丁二烯、丁腈橡胶、丁基橡胶、乙丙橡胶、三元乙丙橡胶(ethylene propylene diene monomer)、氯磺化聚乙烯、聚硫橡胶、聚氨酯、EVA膜、共聚酯以及硅树脂。盖布材料的具体的实例包括硅树脂盖布、盖布、V.A.C.TM DrapeTM、丙烯酸盖布例如可从Avery Dennison获得的丙烯酸盖布、或切割盖布(incise drape)。
敷料组件110还包括复合支架130,复合支架130被定位在表面创伤102的空腔内与歧管120流体连通以用于将减压施加于表面创伤102的空腔,并且用于提供促进组织在表面创伤102的空腔内生长的结构。复合支架130可以部分地或完全地与被治疗的表面创伤102的空腔壁接触。当复合支架130与表面创伤102的壁接触时,复合支架130可以部分地或完全地填充表面创伤102的空隙。复合支架130可以是任何尺寸、形状或厚度,取决于多种因素,例如被实施的治疗的类型或表面创伤102的空腔的性质和尺寸。
在一个例证性的实施方案中,分布歧管120是泡沫材料,当分布歧管120与复合支架130接触或在复合支架130附近时,泡沫材料将减压分布于复合支架130和表面创伤102的空腔。泡沫材料可以是疏水性的或亲水性的。在一个非限制性的实施例中,分布歧管120可以是开放气孔网状聚氨酯泡沫,例如可从德克萨斯州的圣安东尼奥的Kinetic Concepts,Inc.获得的敷料。在其中分布歧管120由亲水材料制造的实施例中,分布歧管120还起作用以将流体芯吸(wick)远离复合支架130和表面创伤102的空腔,同时继续作为歧管向复合支架130提供减压。分布歧管120的芯吸性质通过毛细流动或其他芯吸机理将流体从表面创伤102的空腔抽吸走。亲水泡沫的实例是聚乙烯醇开放气孔泡沫,例如可从德克萨斯州的圣安东尼奥的Kinetic Concepts,Inc.获得的V.A.C.敷料。其他亲水泡沫可以包括由聚醚制造的那些。其他可以呈现亲水特性的泡沫包括被处理或包覆以提供亲水性的疏水泡沫。
参照图2,减压系统200还包括导管连接器119的被定位在盖布122和表皮104之间的凸缘部分219,以及由凸缘部分219支持并且从凸缘部分219延伸入皮下创伤202的空腔中的第三导管218。减压系统200还包括通过第三导管218流体地耦合于导管连接器119的分布歧管220。分布歧管220与分布歧管120(图1)实质上相似,但是由不必在使用敷料组件210之后从患者的身体除去的生物可吸收材料构建。合适的生物可吸收材料可以包括但不限于聚乳酸(PLA)和聚乙醇酸(PGA)的聚合性共混物。聚合性共混物还可以包括但不限于聚碳酸酯、聚富马酸酯和己内酯(capralactone)。分布歧管220可以进一步作为用于新细胞生长的支架,或者支架材料可以与分布歧管220共同使用以促进细胞生长。支架是用于增强或促进细胞生长或组织形成的物质或结构,例如提供用于细胞生长的模板(template)的三维多孔结构。支架材料的例证性的实例包括磷酸钙、胶原、PLA/PGA、珊瑚羟基磷灰石(coral hydroxy apatite)、碳酸盐或经处理的同种异体移植材料。
参照图3,复合支架130包括组织的带(strip),例如脂肪组织的带,其与支架材料的带共同形成夹层状,即分别是组织层134和支架层132,形成层叠物136。然后,层叠物136可以被卷绕为如所示的大体上圆柱形形状,其中一个端部分被卷绕在复合支架130的内部,即内端部分138,并且另一个端部分被卷绕在复合支架130的外部,即外端部分137。支架层132的表面与组织层134的表面流体连通。在一个实施方案中,支架层132是相对薄的并且最好地适合于在组织层134被转移至创伤102、202的空腔之前和之后保持组织层134的存活能力。在另一个实施方案中,支架层132是相对较厚的,使得其不但保持组织层134的存活能力,而且当在创伤102、202的空腔中时随着组织层134生长进入支架层132中使组织层134扩大,增加了容量和体积。应当理解,复合支架130或层叠物136可以在被转移至患者之前在体外使用流体或施加减压来处理,和/或在体内使用来自创伤102、202的空腔的天然流体或使用如下文关于图7中所示的系统描述的其他流体来处理。
当复合支架130如上文描述的被定位在表面创伤102的空腔中时,歧管120与支架层132的边缘流体连通,如上文描述的并且由图1A和3中的箭头139示出的。支架层132优选是生物可吸收的,并且因此将随着在表面创伤102的空腔中的组织以及组织层134在体内生长以填充空腔而被吸收。如上文表明的,复合支架130可以被卷绕为任何尺寸和形状,以填充或部分地填充皮下创伤202以及表面创伤102的空腔。
根据本发明的组织层134可以是任何类型的对于植入来说期望的组织,例如脂肪组织。在某些实施方案中,组织层134的组织是与围绕缺陷(例如创伤)部位的组织相同的类型。组织层134可以是同种异体移植组织、自体移植组织、异种移植组织或可以是在体外从多能细胞的群体产生的组织。在某些方面,组织层134包括组织的实质上完整的切片,该切片被成形为配合支架层132。在某些其他方面,组织层134可以包含原始脂肪抽吸物(lipoaspirate)或从脂肪抽吸物分离的细胞。
在支架层132和包含脂肪组织的组织层134之间的流体连通允许脂肪组织中的细胞保持生存力,同时允许被引入的组织经历血管新生(或对于移植物组织的情况来说为血管再生)。特别地,穿过组织的流体流从组织除去代谢废产物并且将诸如氧的营养素从周围组织抽入所引入的组织中。因此,流体流不但保持组织层134中的细胞的存活能力,而且促进细胞的增殖并且填充组织缺陷,例如表面创伤102。
参照图4,示出了用于将减压施加在患者的身体中的组织部位处以修复表面创伤102的减压系统300的第三例证性的实施方案,并且其包括与图1中的减压系统100相同的部件,如由参考数字表示的。参照图5,示出了用于将减压施加于皮下创伤202的第四减压系统400,并且其包括与图2中的减压系统200相同的部件,如由参考数字表示的。减压系统300和400是分别与系统100和200实质上相同的,除了歧管和复合支架之外。减压系统300、400分别包括敷料组件310和410,敷料组件310和410中的每一个包括分布歧管320和复合支架330。
复合支架330还包括支架层332和组织层334,支架层332和组织层334形成层叠物336,层叠物336也可以被卷绕为大体上圆柱形形状,如图6中所示。卷绕的层叠物336还具有外端部分337和在复合支架330内的内端部分338。然而,在本实施方案中,分布歧管320在复合支架330的外端部分337处流体地耦合于支架层332,而不是在支架层332的边缘处流体地耦合于支架层332。支架层332具有足以将减压流体地连通于组织层334的实质上全部长度的孔隙度。支架层332可以具有朝向复合支架330的内部增加的孔隙度,以在复合支架330内产生减压梯度。在其他方面,支架层332与支架层132实质上相似。当复合支架330被定位在任意类型的创伤102、202中时,分布歧管320被流体地耦合于第三导管218,用于将减压分布于复合支架330,如上文描述的。然而,在本实施方案中,复合支架330在创伤102、202的空腔内取向(orient),使得复合支架330的纵轴线被调整为与表皮104大体上平行而不是垂直。该分布歧管320和复合支架330的结构和取向可以更好地适合于不同类型的创伤,例如具有穿过表皮104和真皮106的切入型切口(incisional cut)的表面创伤或皮下创伤。
参照图7,减压治疗系统100、200、300和400(共同地,“系统”)还可以包括可操作地连接于第二导管118以测量被施加于歧管120、220、320和420(共同地,“歧管”)的减压的压力传感器140。系统还包括电连接于压力传感器140和减压源112的控制单元145。压力传感器140测量在创伤102、202(共同地,“创伤”)的空腔内的减压并且还可以指示第二导管118是否被血液或其他体液堵塞。压力传感器140还向控制单元145提供反馈,控制单元145调节由减压源112通过第二导管118施加于歧管的减压治疗。减压治疗系统还可以包括通过第四导管152流体地耦合于第二导管118并且操作性地连接于控制单元145的流体供应150。流体供应150可以用于向用于创伤的支架130和330(共同地,“支架”)传送生长和/或愈合剂,包括但不限于抗菌剂、抗病毒剂、细胞生长促进剂、冲洗流体(irrigation fluid)或其他化学活性剂。系统还包括被定位在第四导管152中以控制通过其的流体的流量的第一阀154,以及被定位在第二导管118中在减压供应112和位于第二导管118和第四导管152之间的接合处之间以控制减压的流的第二阀156。控制单元145被操作性地连接于第一和第二阀154、156,以分别控制减压和/或来自流体供应150的流体向歧管的传送,如被施用于患者的具体的治疗所需要的。流体供应150可以传送如上文表明的液体,但是还可以将空气传送至歧管,以促进愈合以及帮助在创伤的部位处的排出。
在图7中图示的实施方案中,减压源112是电驱动真空泵。在另一个实施方案中,代替的是,减压源112可以是不需要电功率的手动致动的或手动管理的泵。代替的是,减压源112可以是任何其他类型的减压泵,或可选择地是壁吸入口,例如在医院和其他医疗设施中可用的那些。减压源112可以被容纳在减压治疗单元(未示出)内或与减压治疗单元共同使用,减压治疗单元还可以容纳进一步帮助将减压治疗施用到创伤的传感器、处理单元、报警指示器、存储器、数据库、软件、显示单元和用户界面。在一个实施例中,传感器或开关(未示出)可以被布置在减压源112处或附近,以测定由减压源112产生的源压力。传感器可以与监测和控制由减压源112传送的减压的控制单元145通信。
如本文所使用的,术语“歧管”是指被提供以辅助向组织部位引导减压、向组织部位传送流体或从组织部位除去流体的物质或结构。歧管可以包括多个流动通道或路径,多个流动通道或路径被互相连接以改进被提供至歧管周围的组织区域以及被从歧管周围的组织区域除去的流体的分布。歧管的实例可以包括但不限于具有被配置以形成流动通道的结构要素的工具、蜂窝状泡沫例如开孔泡沫、多孔的组织收集物(collection)、以及包括或固化以包括流动通道的液体、凝胶和泡沫。对根据本发明的歧管以及它们的用途的详细描述在下文提供。
如本文所使用的术语“支架”是指被施加于创伤或缺陷或在创伤或缺陷中的提供用于细胞的生长和/或组织的形成的结构基质的物质或结构。支架经常是立体的多孔结构。支架可以用细胞、生长因子、细胞外基质组分、营养素、整联蛋白或其他用于促进细胞生长的物质来注入,用细胞、生长因子、细胞外基质组分、营养素、整联蛋白或其他用于促进细胞生长的物质来包覆,或包含细胞、生长因子、细胞外基质组分、营养素、整联蛋白或其他用于促进细胞生长的物质。支架可以通过引导流通过基质而采取歧管的特性。歧管可以向支架和组织传输流;在减压治疗的背景中,歧管可以与支架流体连通。对根据本发明的支架以及它们的用途的详细描述在下文提供。
因此,在此公开的本发明公开了用于控制流体流的基于细胞水平的型式的方法和装置,其将允许以微观的、纳米观的或介观的规模来控制型式化(patterned)的蛋白质组织,其负责提供用于为组织的功能性再生所必需的细胞迁移、分化和相似行为的结构歧管以及可选择的支架材料。与组织修复和再生相关的当前技术水平的被动性质相比,本文公开的方法、支架、歧管、流源和系统提供了一种主动机制,通过这种主动机制,促进了蛋白质的内源性沉积以及具有生物化学以及物理学线索的临时基质的组织,以引导支架或组织空间的细胞定居。因此,本发明通过开发定向流体流(directed fluid flow)的主动力,提供基于流体流影响下的生物学需要而在其上设计歧管和支架的框架,增强了现有的技术。流动矢量和路径被用于增强蛋白质沉积和细胞定居。本文提供的系统被设计为促进具有从健康组织边缘经过支架或组织部位的无缝过渡的临时基质网络的建立,以促进功能性组织连续。
因此,本文公开的装置、方法和系统提供了用于主动引导经过被植入的支架或在组织部位内的组织再生以促进机能恢复的手段。这种主动引导通过受控流体流的机理发生,其可以用于启动或增强身体自身的自然愈合过程的早期阶段;歧管可以提供产生受控流体流所必需的主动引导。特别地,歧管提供的受控流动矢量可以用于帮助细胞和蛋白质向支架中的定向流入。在组织部位或支架内产生特定流路径可以导致蛋白质,例如胶原和纤维蛋白在歧管、支架或组织空间内的型式沉积。来自被结合在临时基质内的细胞因子、生长因子和细胞的生物化学线索可以与临时基质和细胞外基质的天然物理线索共同作用,以引导内源性细胞在愈合的修复阶段期间的后续的迁移。这些线索以从健康组织发出并且经过支架或组织空间的轨迹(track)的形式起作用,以帮助形成用于有次序的组织再生的连续的引导路径。
为此,本公开内容提供了基于流体流原理的为特定生物学需要所设计的独特的歧管技术。在某些方面,本发明涉及新的用于创伤愈合、流(或梯度)激活的组织工程的方法。以根本的形式,该方法涉及流的源或发生器,源或发生器形成梯度,用于内生或外生流体的进入、离开或穿过组织空间的受控运动,从而用于蛋白质的有次序的沉积和/或细胞因子和生长因子的空间浓缩,同时随后形成被定向取向的(directionally oriented)临时基质。本文定义的组织空间包括但不限于围绕组织缺损或损伤,包括创伤或切口,的部位的区域。
进入组织空间、穿过组织空间或从组织空间出来的流体流可以通过在包括歧管和/或支架的系统中包括另外的元件被细化(refine)和引导。系统的各协调的元件被设计为产生流动参数、路径和型式,流动参数、路径和型式按比例(in scale)被足够详细地设计从而能够影响和引导蛋白质的受控吸附、基质的组织以及特定细胞类型的有次序的定居。系统的分别的元件如下。
流的源或发生器。流通过引入力势(mechanical potential)、化学势和/或电势的变化的方法或装置被诱导进入组织空间、穿过组织空间或从组织空间出来。这些流的发生器提供从内生或外生流体的部位或储藏器到流发生器或其扩展元件(即歧管或支架)的放置位置的势能的变化或梯度。在一个实施方案中,流的源包括减压的源。根据本发明的系统和装置还可以包括控制负压的应用以及被施加于歧管的负压的量的阀或阀的阵列。在某些方面,本文描述的支架和/或歧管包括压力传感器。因此,在某些实施方案中,由源施加的负压的量基于在歧管或支架中或在组织损伤的部位处感应到的负压的量而调节。
歧管。流发生器是用于刺激流体的流的驱动力。歧管是用于细化在流的源或发生器和组织空间之间的流的型式的装置。宏观规模水平的流(macroscale level of flow)被用于定向位置(directed localization)的专用歧管细化为单一的点或细化为多个被选择性地定位的点,以用于在歧管/支架内以及最终在组织空间内产生微观规模流路径(microscale flowpathway)的初始化部位。歧管还可以作为用于从组织空间除去流体的导管以及作为用于将外生流体传送至组织空间的装置。
歧管通常是指用于辅助施加力学的、化学的、电的或相似的变化以及将力学的、化学的、电的或相似的变化转化为流体的流的变化的物理物质或结构,流体的流在本文中被定义为液体、气体和其他可变形的物质例如蛋白质、细胞以及其他的相似的部分的运动。因此,本物理工具包括用于排出或排空能够转化支架中的流体的运动的压力、流体和相似的物质的单一的点或多个点,如上文所定义的。这可以包括但不限于将外生因子,例如细胞和/或治疗部分,经过歧管中存在的内腔或多个内腔引入支架中。此外,如本文所使用的,歧管包括用于使流体从支架朝向流的点源返回而进入或引入的单一的点或多个点。
被歧管分布的流可以引导内源性蛋白、生长因子、细胞因子和细胞从它们在宿主内的固有地点以有次序的方式向组织空间或支架运动。沿这些路径的流的建立导致蛋白质的沉积和产生将宿主连接于支架的界面内生网络(interfacial endogenous network)的临时基质。这种基质的延伸可以使用流促进支架设计通过歧管流初始化部位的选择性定位而建立在支架内。有次序的蛋白质沉积和临时基质提供刺激细胞沿贯穿支架和组织空间的定向路径附接和迁移的生物化学的和物理的框架。所得到的蛋白质、生长因子和细胞的内生网络提供了身体自身的组织修复和再生机制的后续阶段可以基于其建立的基础。
当就位时,歧管与流发生源和,如果存在的话,支架共同作用。流发生源包括但不限于负压的发生器;正压的发生器;以及渗透流的发生器。在歧管中建立的流梯度可以通过支架被进一步细化,以向支架传送流梯度,以优化通过支架的流,如具体的缺陷所需要的。本文公开的实施方案中的许多是能够为了定向组织再生的目的,可选择地通过物理支架,将压力以及类似物的变化转化为流体的受控运动的歧管。这些实施方案一般被指定用于特定组织的再生中的特定应用,但是不限于其中的特定组织。
为了实现为了组织再生的目的诱导流的目标,上文提到的力学的、化学的或电的动量的变化必须被从单一的梯度源朝向物理基材或支架转化,以导致蛋白质吸附、基质组织、细胞迁移以及其他与组织再生相关的行为的细胞水平的变化。这些变化在本质上是多变量的,并且可以包括当被施加于创伤的部位或期望的组织再生的部位时导致被施加于支架的压力的物理变化的力学变化、导致引出蛋白质和/或离子浓度的梯度从而产生能够诱导流的渗透梯度的化学变化、或产生允许电信号从点源的传播的电流的梯度/离子交换的电变化。然而,将理解,本申请人不被梯度和流体流通过其诱导组织修复或生长中的有利结果的任何具体机制束缚。为了有利地将这些梯度传输至组织,需要物理工具将流的路径从其源引导至支架或组织部位,反之亦然。
在某些实施方案中,歧管包括紧邻支架的内容物的或在支架的内容物内的物理结构,并且用于传播物理参数,无论其是力学的、化学的、电的还是在本质上相似的事物,的变化,以用于将这些变化从其点源引导至支架材料的手段。这种歧管相对于其关于支架地点的地点的放置可以是对于帮助具体的组织类型的受控的且定向再生来说非常重要的。例如,歧管可以被定位为使得植入的组织,例如组织层,在歧管和在组织部位处的血液源之间,使得来自血液源的流体或间质液(interstitial fluid)可以流动至或流动经过植入的组织
歧管可以包含生物可吸收材料或生物惰性材料。实例包括非生物可吸收材料,例如医学级硅氧烷聚合物、金属、聚氯乙烯(PVC)和聚氨酯(例如)。还可以使用生物可吸收聚合物,例如胶原、聚乳酸(PLA)、聚乙醇酸(PGA)、乳酸-乙醇酸共聚物(PLGA)、多糖(例如藻酸盐)、水凝胶或聚乙二醇、或其组合。在某些方面,歧管包含力学上刚性的材料,例如磷酸钙、羟基磷灰石、DBM、碳酸盐或生物玻璃。这样的力学上刚性的材料可以在填充硬组织缺陷上具有特别的用途。某些歧管还是非生物可吸收材料和生物可吸收材料的混合物。通常,用于支架的材料还可以被用于形成歧管,并且这样的材料在下文进一步详细描述。在某些方面,歧管材料是结构化的以包括为了改进的生物吸收性质的高空隙分数(high voidfraction)。在某些实施方案中,歧管可以体现支架的特性。
支架。生物的和合成的支架被用在组织工程领域中以支持蛋白质附着和细胞向内生长来用于组织修复和再生。支架技术的领域的现有技术水平依赖于用于蛋白质的吸附和细胞的迁移的周围组织空间的固有特性。用于根据本发明的用途的支架被耦合于歧管,提供用于引导组织部位中的流体流的路径的物理引导,产生分别用于粘附性蛋白质和细胞的运动和迁移的通路,以上构成了在组织空间内以预先确定的组织型式建立临时基质的一部分。所描述的用于流体流诱导的以及梯度诱导的组织生成的方法和装置具有对支架的设计的直接提示。在该内容中,支架用于将组织空间内的流体流的路径细化为从流体源至歧管内的流初始化点的细胞水平型式。支架可以体现歧管的特性或与歧管结合,以用于对组织部位内的流路径的细化。在某些方面,支架是包括为了改进的生物吸收性质的高空隙分数的网状结构。
合适的支架材料的非限制性的实例包括细胞外基质蛋白质,例如纤维蛋白、胶原或纤连蛋白,以及合成的或天然存在的聚合物,包括生物可吸收聚合物或非生物可吸收聚合物,例如聚乳酸(PLA)、聚乙醇酸(PGA)、乳酸-乙醇酸共聚物(PLGA)、聚乙烯吡咯烷酮、聚己内酯、聚碳酸酯、聚富马酸酯、己内酯、聚酰胺、多糖(包括藻酸盐(例如海藻酸钙)和壳聚糖)、透明质酸、聚羟基丁酯、聚羟基戊酸酯、聚二噁烷酮、聚乙二醇、泊洛沙姆、聚磷腈、聚酐、聚氨基酸、多原酸酯、聚缩醛、聚氰基丙烯酸酯、聚氨酯、聚丙烯酸酯、乙烯-醋酸乙烯酯聚合物以及其他被酰基取代的醋酸纤维素以及其的衍生物、聚苯乙烯、聚氯乙烯、聚氟乙烯、聚(乙烯基咪唑)、氯磺化聚烯烃、聚环氧乙烷、聚乙烯醇、以及尼龙。支架还可以包括陶瓷例如羟基磷灰石、珊瑚磷灰石、磷酸钙、硫酸钙、碳酸钙或其他碳酸盐、生物玻璃、同种异体移植物、自体移植物、异种移植物、脱细胞化(decellularized)组织、或以上中的任何的复合物。在具体的实施方案中,支架包含胶原、聚乳酸(PLA)、聚乙醇酸(PGA)、乳酸-乙醇酸共聚物(PLGA)、聚氨酯、多糖、羟基磷灰石或聚乙二醇。此外,支架可以包含在支架的分离的区域中的或被非共价地或共价地(例如共聚物,例如聚环氧乙烷-聚丙二醇嵌段共聚物或三元共聚物)或以其组合的方式结合的任何两种、三种或更多种材料的组合。合适的基质材料在例如Ma和Elisseeff,2005以及Saltzman,2004中讨论。
生物活性剂
在某些方面,根据本发明的装置和方法涉及生物活性剂。生物活性剂可以,在某些情况下,被直接地结合至歧管或支架材料上(即,用于产生生物活性歧管和/或支架)。例如,帮助组织生长的剂,例如胶原或纤维蛋白,可以被直接地结合至歧管或支架材料的上或内部。同样地,在其中异常的免疫响应需要被避免的应用(例如组织移植)中,诸如雷帕霉素的免疫调节剂可以被结合入歧管或支架结构中。
在另外的方面,可溶生物活性剂可以借助于经过组织部位的流在组织损伤的部位处引入。例如,歧管可以与流体源流体连通并且生物活性剂可以被引入流体源中并且从而被引入歧管和组织层中。
对于各种应用来说可用的生物活性生长因子的非限制性的实例是生长激素(GH)、骨形态发生蛋白(BMP)、转化生长因子-α(TGF-α)、TGF-β、成纤维细胞生长因子(FGF)、粒细胞集落刺激因子(G-CSF)、粒细胞/巨噬细胞集落刺激因子(GM-CSF)、表皮生长因子(EGF)、血小板衍生生长因子(PDGF)、胰岛素样生长因子(IGF)、血管内皮生长因子(VEGF)、肝细胞生长因子/离散因子(HGF/SF)、白细胞介素、肿瘤坏死因子-α(TNF-α)或神经生长因子(NGF)。在某些应用中,生物活性分子可以是引导诸如VEGF的血管化的分子。
组织修复和再生。本文公开和装置和系统可以用于在包括下文的各种背景中的组织修复和工程。
损失组织(lost tissue)的修复和再生。流的发生器可以被与歧管和/或支架结合以引导在损伤的部位处的损失组织或受损功能的再生。使用本发明的方法、支架、歧管、流源和系统可以导致从外伤性损伤、手术、烧伤或其他原因(例如感染或自体免疫疾病)损失的组织的再生。
阻滞组织疾病状态的进程。流的发生器可以被与歧管和/或支架结合以阻滞受影响的组织的疾病进程,例如在例如自体免疫疾病和诸如葡萄球菌感染(Staph infection)的消耗性感染(wasting infection)中发生的。
组织生存力的保持。流的发生器可以被与歧管和/或支架结合以保持用于体外研究、活体外(ex vivo)支架或植入物制备或体内移植的外植组织例如脂肪组织的生存力。与歧管结合的流的发生器可以用于向组织提供营养素流体流以及用于控制从组织除去废物。
组织的扩大。流的发生器可以被与歧管和/或支架结合以促进现有的组织的扩大。本发明的方法、支架、歧管、流源和系统可以用于在需要或期望另外的组织量时引导组织的生长。组织扩大可以在体内或活体外实现,例如在向组织提供所需要的营养素的组织培养环境中,其中营养素通过减压的施加而被灌注。
组织形成的加速或促进新的组织形成。流的发生器可以与歧管和/或支架结合以在自然愈合响应(natural healing response)内加速组织形成的速率。本发明的方法、支架、歧管、流源和系统可以用于通过增加临时基质的形成,帮助其稳定定位以及辅助细胞向组织空间的募集来加速组织生长。同样地,本文公开的装置和方法可以用于促进在所选择的组织部位处的新组织形成。这样的新组织形成可以用于填充(即增加体积和质量)组织部位。这样的方法可以用于再造因为损伤而损失的、在生长期间变形的组织特征,或用于改进特征的外观。
刺激干细胞沿特定路径的分化。流的发生器可以与歧管和/或支架结合以刺激干细胞或其他多能细胞向特定谱系的分化。使用本发明的方法、支架、歧管、流源和系统的施用流可以用于将多能细胞引向所需的特定细胞谱系,以促进组织空间中的生长。例如,脂肪(例如褐色或白色脂肪细胞)祖细胞可以作为组织层的一部分被提供并且在体外的基质上或在体内的组织部位处的基质上生长。
将蛋白质、基质、细胞或药物引入体内环境中。流的发生器可以被与歧管和/或支架结合以将外生生长因子、蛋白质、细胞或药剂引入组织空间中,以加强组织修复、再生和/或保持。
在体外产生用于体内植入的基质。流的发生器可以被与歧管和/或支架结合以帮助可以后续地用于体内移植的基质在体外形成。
促进移植组织的整合。流的发生器可以被与歧管和/或支架结合以促进移植组织向宿主环境中的整合。这可以适用于自体移植移植物、同种异体移植移植物或异种移植移植物。移植的组织可以是从周围的组织切下的组织的完整部分或被实质上分裂的组织,例如脂肪抽吸物。在这样的应用中,歧管材料可以包括免疫抑制剂以用于降低组织排斥的可能性。
在体外引导细胞外基质(ECM)的沉积和取向。流发生器可以与歧管和/或支架结合以引导由细胞和组织表达的ECM的定向沉积和取向。ECM的定向取向对组织和引导后续的细胞层和组织的附接和定居有影响。
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所有在本说明书中引用的参考文献都在此以引用方式并入。本文对参考文献的讨论仅意在概括作者作出的结论,并且不作出任何参考文献构成现有技术的承认。申请人保留质疑所引用的参考文献的准确性和相关性的权利。
根据上文,将看到的是,本发明的优点被实现并且其他优点被获得。因为可以作出对上文的方法和内容的各种变化而不偏离本发明的范围,所以意图的是,在以上描述中包含的以及在附图中示出的所有内容应当被解释为是例证性的并且不作为限制性意义的。
Claims (28)
1.一种用于治疗具有空腔的创伤的系统,所述系统包括:
压力源,其用于供应减压;
支架,其包括支架层和组织层,所述支架层具有边缘并且以与所述组织层流体连通的方式形成层叠物,所述层叠物被卷绕成具有两个端面的大体上圆柱形形状,所述支架用于定位在所述创伤的所述空腔内并且向所述创伤提供减压;
歧管,其与所述压力源和所述支架流体连通,以向所述支架层和所述创伤提供减压;以及
盖布,所述盖布适合于覆盖所述创伤内的所述支架和所述歧管,以实质上保持由所述歧管提供在所述创伤内的减压。
2.根据权利要求1所述的系统,其中所述盖布由实质上不可渗透的材料形成。
3.根据权利要求1所述的系统,其中所述歧管被定位为毗邻所述支架的所述端面中的一个,与所述支架层的所述边缘中的一个流体连通。
4.根据权利要求1所述的系统,其中所述层叠物还包括所卷绕的层叠物的端部分并且所述支架层也包括端部分,并且其中所述歧管与所述支架层的所述端部分流体连通。
5.根据权利要求1所述的系统,其中所述组织层包括脂肪组织。
6.根据权利要求5所述的系统,其中所述脂肪组织来源于脂肪抽吸物。
7.根据权利要求1所述的系统,其中所述组织层包括同种异体移植组织、自体移植组织或异种移植组织。
8.根据权利要求1所述的系统,其中所述支架层由生物惰性材料或生物可吸收材料形成。
9.根据权利要求1所述的系统,其中所述支架层由泡沫或凝胶材料形成。
10.根据权利要求1所述的系统,其中所述支架层包含生物活性剂,所述生物活性剂从由抗生素、抗体和生长因子组成的组中选择。
11.根据权利要求10所述的系统,其中所述生物活性剂是生长激素(GH)、骨形态发生蛋白(BMP)、转化生长因子-α(TGF-α)、TGF-β、成纤维细胞生长因子(FGF)、粒细胞集落刺激因子(G-CSF)、粒细胞/巨噬细胞集落刺激因子(GM-CSF)、表皮生长因子(EGF)、血小板衍生生长因子(PDGF)、胰岛素样生长因子(IGF)、血管内皮生长因子(VEGF)、肝细胞生长因子/离散因子(HGF/SF)、白细胞介素、肿瘤坏死因子-α(TNF-α)或神经生长因子(NGF)。
12.根据权利要求8所述的系统,其中所述支架层包含胶原。
13.根据权利要求1所述的系统,其中所述歧管包含生物惰性材料。
14.根据权利要求1所述的系统,其中所述歧管包含生物可吸收材料。
15.一种用于治疗具有空腔的创伤的装置,所述装置包括:
支架,其包括支架层和组织层,所述支架层具有边缘并且以与所述组织层流体连通的方式形成层叠物,所述层叠物被卷绕成具有两个端面的大体上圆柱形形状,所述支架用于定位在所述创伤的所述空腔内并且向所述创伤提供减压;
歧管,其具有用于耦合于减压的源的口并且与所述支架流体连通,以向所述支架层和所述创伤提供减压;以及
盖布,所述盖布适合于覆盖所述创伤内的所述支架和所述歧管,以在所述歧管提供减压时实质上保持所述创伤内的减压。
16.根据权利要求15所述的装置,其中所述盖布由实质上不可渗透的材料形成。
17.根据权利要求15所述的装置,其中所述歧管被定位为毗邻所述支架的所述端面中的一个,与所述支架层的所述边缘中的一个流体连通。
18.根据权利要求15所述的装置,其中所述层叠物还包括所卷绕的层叠物的端部分并且所述支架层也包括端部分,并且其中所述歧管与所述支架层的所述端部分流体连通。
19.根据权利要求15所述的装置,其中所述组织层包括脂肪组织。
20.根据权利要求19所述的装置,其中所述脂肪组织来源于脂肪抽吸物。
21.根据权利要求15所述的装置,其中所述组织层包括同种异体移植组织、自体移植组织或异种移植组织。
22.根据权利要求15所述的装置,其中所述支架层由生物惰性材料或生物可吸收材料形成。
23.根据权利要求15所述的装置,其中所述支架层由泡沫或凝胶材料形成。
24.根据权利要求15所述的装置,其中所述支架层包含生物活性剂,所述生物活性剂从由抗生素、抗体和生长因子组成的组中选择。
25.根据权利要求24所述的装置,其中所述生物活性剂是生长激素(GH)、骨形态发生蛋白(BMP)、转化生长因子-α(TGF-α)、TGF-β、成纤维细胞生长因子(FGF)、粒细胞集落刺激因子(G-CSF)、粒细胞/巨噬细胞集落刺激因子(GM-CSF)、表皮生长因子(EGF)、血小板衍生生长因子(PDGF)、胰岛素样生长因子(IGF)、血管内皮生长因子(VEGF)、肝细胞生长因子/离散因子(HGF/SF)、白细胞介素、肿瘤坏死因子-α(TNF-α)或神经生长因子(NGF)。
26.根据权利要求22所述的装置,其中所述支架层包含胶原。
27.根据权利要求15所述的装置,其中所述歧管包含生物惰性材料。
28.根据权利要求15所述的装置,其中所述歧管包含生物可吸收材料。
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