CN110430915A - 用于递送细胞疗法的方法和设备 - Google Patents
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Abstract
一种用于递送细胞疗法的方法和设备,所述细胞疗法经由经皮进入循环引入,并递送到血管损伤介入部位。
Description
本申请要求2016年11月2日提交的美国临时专利申请第62416189号的优先权。
背景技术
心血管疾病是全球死亡的主要原因。动脉粥样硬化可导致主要冠状动脉的症状性阻塞,从而导致心绞痛或心肌梗死。最常见的治疗包括旁路手术、粥样斑块切除术和球囊血管成形术与支架植入的组合。内膜增生是粥样斑块切除术、血管成形术和支架置入术最常见的失效模式。这一主要问题发生在所有经皮冠状动脉介入之后,导致所涉及的冠状动脉在第一年内以高达15-30%的比率再狭窄。内膜增生由迁移到内膜空间的血管平滑肌细胞的积聚,以及细胞外基质材料的沉积组成。后果是受影响血管的腔直径减小,导致终末器官缺血。治疗内膜增生的病因以防止再狭窄的重要性在其患病率和已经提出解决此问题的多种装置和治疗方面显而易见。
最初的治疗涉及通过开发支架来预防在血管成形术之后因内膜增生引起的再狭窄。这些治疗由于内膜增生生长穿过支架中的孔而失败。随后开发覆膜支架防止此问题,但内膜增生在覆膜支架的端部处出现,造成再狭窄。最近的治疗试图解决内膜增生过程中的特定步骤或因素。它们的失败通常可归因于内膜增生产生所涉及的复杂机制以及难以提供有效治疗。内膜增生的原因包括血液动力学因素,如剪切应力和壁拉应力,包括内皮剥脱和内侧撕裂的损伤,炎症和遗传因素。这些原因中的每一个都涉及复杂的途径和各种细胞和化学介质。已经开发了大量药物疗法以试图通过靶向特定途径中的特定步骤或细胞或使起始原因减至最少来减少内膜增生的产生。
目前用于减少内膜增生的治疗包括使用药物洗脱支架和药物洗脱血管成形术球囊。这些支架和球囊中的一些涂有各种药物,这些药物通过与血管成形术或介入部位直接接触而从支架或球囊表面转移。其它则允许药物在血管壁附近释放。药物随后接触血管组织并对肥大性疤痕形成反应(内膜增生)发挥其抑制作用,目的是降低在治疗部位再次阻塞的可能性。
现有技术包含许多用于将药物递送到血管的装置的实例。其中有Wolinsky等人的美国专利5,087,244;Hanson等人的美国专利5,985,307;和Lary等人的美国专利7,985,200。
另一种严重的血管疾病病况是动脉瘤破裂,它是全世界死亡的主要原因。目前,治疗方法是手术切除或消融;不存在用于预防或阻止这种疾病的药物治疗。已经证明动脉瘤疾病的病理生理学为动脉变性,具有显著的炎症组分。发炎过程位于动脉壁和周围的外膜周围脂肪和组织中。
制备和使用脂肪来源干细胞的现有技术包括Fraser等人的美国专利8,691,216和Fraser等人的美国专利9,198,937,其中这类干细胞用于通过经由配备有球囊的导管递送来促进伤口愈合和改善肝损伤。
最近已经证明,通过将干细胞从血管外部引入血管成形术诱发的动脉损伤部位,可以减少内膜增生。(《间充质干细胞对在球囊血管成形术之后内膜增生的抑制性作用》(Inhibitory Effects of Mesenchymal Stem Cells in Intimal Hyperplasia AfterBalloon Angioplasty),Ae-Kyeong Kim,PhD,a Min-Hee Kim,a Do-Hyung Kim,a Ha-NlGo,a Seung-Woo Cho,PhD,b Soong Ho Um,PhD,c and Dong-Ik Kim,MD,PhD,http://dx.doi.org/10.1016/j.jvs.2014.08.058)
还认为干细胞疗法可能是动脉瘤的候选药物疗法。目前没有可用于或适合于治疗动脉瘤疾病的细胞疗法的递送***。受影响的动脉壁的脆弱性为疗法的递送带来了特殊的挑战,在治疗时伴随操纵动脉瘤组织的风险。
最后,据相信干细胞疗法可以用作其它疾病病况的医学治疗,前提是细胞悬浮液可以直接递送到需要治疗的组织附近,并且所需方法为使用经皮进入经由循环***递送。
用于这种类型应用的用于将细胞疗法递送到血管腔的装置尚未开发或商业化。当前涂布药物的介入装置和细胞疗法之间的区别在于为了可行,干细胞必须新鲜制备并保持在悬浮液中(与涂布在介入设备上并保持干燥状态以便储存相反)。另一个区别是干细胞(和其它细胞悬浮液)与药物分子相比尺寸更大,并且在手术完成后通过血液流过血管从介入部位扫除。因此,需要一种将适当制备的新鲜干细胞或非干细胞的液体悬浮液递送到介入部位并将其保留在那里的新方法。
发明内容
本发明为一种用于递送细胞疗法的方法和设备,所述细胞疗法经由经皮进入引入循环,并递送到血管损伤或介入部位或周围组织。将细胞悬浮液从血管腔内传递到内膜、内膜下间隙、中膜、外膜、外膜周空间或从邻近血管的腔内传递到动脉周围组织和脂肪。
附图说明
图1描绘本发明的递送装置的实施例的横截面图。
具体实施方式
本发明的一优选实施例为球囊,其在其表面携带一个或多个具有孔口或连续沟槽的管路。在膨胀以使斑块层破裂之后,引入细胞悬浮液穿过管路,在所述管路中,细胞悬浮液从孔口(或沟槽)流入血管壁。此实施例可配备有中心通道以容许在膨胀期间发生血液流动。细胞悬浮其中的介质可为生物中性或活性溶液,并可任选地包含药物、生物制剂和其它添加剂。
图1中所说明的本发明的递送装置为环形球囊(10),在其外表面(20)上具有中空刚性尖刺(30)。此球囊连接于常规导管(未示出)以经皮进入到处于治疗下的血管并以以未充气或最小充气状态定位在血管中。环形球囊的内壁(25)可以由相对较硬的材料制成,以便于球囊***和放置。一旦就位,可以通过在压力下引入细胞悬浮液来使球囊膨胀,其既使球囊膨胀(10),又将中空刚性尖刺(30)驱动进入并穿过斑块层,并通过尖刺(30)传递悬浮液进入血管壁的斑块和/或所需结构。然后将球囊(10)放气并取出,留下干细胞,但保护其免于在血流中被扫除。因为球囊(10)为环形,所以从不会中断穿过处于治疗中的血管的血流。
在一替代实施例(未示出)中,球囊(10)可为球形或细长的,但并非环形,并且在膨胀期间将阻断穿过处于治疗中的血管的血流。球囊(10)可任选地具有在近端和远端处的环形法兰(未示出)。这些法兰接合血管壁,并用于防止血管壁与外表面(20)之间的血液流动,而是引导血液穿过环面。
本发明的用于治疗内膜增生的方法需要待治疗的血管内的斑块层破裂或穿透,以及干细胞或非干细胞的悬浮液传递到内膜、内膜下间隙、中膜、外膜和/或外膜周空间的斑块下方。斑块破裂可以通过球囊膨胀(如血管成形术中常见的),或通过其它机械手段,例如在安放在血管中之后压缩支架状装置以增加其直径。斑块破裂可以通过常规手段,例如在根据本发明的干细胞的引入之前并与根据本发明的干细胞的引入分离的球囊膨胀,或者可以组合在单个装置中,所述装置既使斑块破裂又随后引入细胞悬液。在将本发明的递送装置安放在血管内之后,斑块的穿透可以通过尖刺或类似结构的延伸来实现。在任何一种情况下,在破裂或穿透之后,在足够的压力下递送干细胞的悬浮液以将细胞移动到处于治疗中的血管的斑块层和/或所选择结构性层中的一个或多个,它们在移除递送装置之后仍保留其中。
本发明的递送装置的另一替代实施例(未示出)为螺旋或双螺旋布置的薄管,其具有沿管长度间隔的小孔。外观与常规支架类似,视需要使用导管将装置***血管中并定位。然后将其拉到一起以增加其直径(通过移动锥形构件,未示出),从而用于使斑块层破裂并深深地嵌入斑块中。或者,所述装置可以由记忆金属形成,所述记忆金属在没有约束鞘时膨胀,或者在加热到体温时膨胀。然后使用导管将基于细胞的悬浮液引入管中,并且此悬浮液通过小孔离开管。在引入干细胞后,将装置拉长以减小其直径,使其与血管壁脱离,并将其与导管一起取出。
又一个实施例是一种多凸起球囊,在每个凸起部的顶点处具有小孔或中空尖刺,其中它与血管壁接触。
又一个实施例是多凸起球囊,在凸起部之间的空间内具有一个或多个孔口,所述空间界定可以填充细胞悬浮液的通道,以提供斑块层与悬浮液之间增加的接触面积。在此实施例中,使用如上所述的环形法兰容纳细胞悬浮液,并引导血液穿过球囊中的中央中空腔,或者穿过球囊外表面上的交替通道,在这种情况下环形法兰具有与这类通道或中央腔连通的孔口或凹槽。
如上所述的每个气囊当然可以具有双腔设计以允许使用流体膨胀,所述流体分开待递送到血管壁的细胞悬浮液且与其不同。
对于针对动脉瘤治疗的介入,先前描述的能够完全穿透静脉壁的细胞悬液递送***可用于将细胞疗法递送到周围的动脉周围组织和脂肪中而不是直接递送到动脉瘤动脉壁中。大多数动脉邻近配对静脉。细胞悬浮液递送装置经由相邻静脉嵌入且布置在静脉中。在布置时,装置上的中空尖刺穿透静脉壁进入动脉瘤样动脉周围的组织中。通过尖刺递送细胞制剂,之后取出并移出装置。或者,细胞制剂可以经由导管递送,所述导管被引导接触并提供抵靠静脉壁的支撑物。在与壁接触后,可以布置一个或多个针或尖刺,并将注射剂输送到动脉周围组织中。
虽然已经在优选实施例中描述了本发明,但是应该理解,已经使用的词语是描述性词语而不是限制性词语,并且可以在所附权利要求的范围内,在不脱离本发明的范围和精神下在更广泛的方面进行改变。相反,在权利要求书的等效物的范围以及区间内且在不脱离本发明的精神情况下可以进行细节上的各种修改。发明人进一步要求,符合其权利要求的范围应符合在本申请提交(以及本申请获得优先权的申请(如果有的话))之日存在的法律规定的最广泛的解释,并且不得因随后的法律变更缩小所附权利要求的范围,因为这类缩小范围将构成事后判决,以及在没有正当程序或公正补偿的情况下采取行动。
Claims (16)
1.一种细胞悬浮液递送装置,其包含外部可变形部件,所述外部可变形部件具有带有多个突起以在定位于血管腔内时刺穿所述血管的一个或多个层(包括斑块层)的外表面,和界定内腔的内表面,每个突起具有孔,所述孔与所述内腔流体连通且具有足够直径以容许悬浮于液体介质中的细胞从所述内腔穿过所述孔并进入所述斑块层、所述血管的一个或多个层、或血管周围组织。
2.根据权利要求1所述的细胞悬浮液递送装置,其进一步包含连接到所述装置的导管,所述导管具有与所述内腔流体连通的腔。
3.根据权利要求1所述的细胞悬浮液递送装置,其进一步包含接合到所述外部可变形部件的内部部件,所述内部部件界定具有环形腔以及内表面和外表面的环面,所述突起仅定位于所述环形腔外部的外表面。
4.根据权利要求3所述的细胞悬浮液递送装置,其进一步包含连接到所述装置的导管,所述导管具有与所述内腔流体连通的腔。
5.根据权利要求3所述的细胞悬浮液递送装置,其中所述内部部件界定不可变形环形腔。
6.根据权利要求1所述的细胞悬浮液递送装置,其中所述突起刺穿血管和其周围组织的一个或多个层,所述一个或多个层选自包含以下的层的组:斑块、内膜、内膜下间隙、中膜、外膜、外膜周空间和血管周围组织。
7.根据权利要求1所述的细胞悬浮液递送装置,其中所述突起具有超过一种长度。
8.根据权利要求1所述的细胞悬浮液递送装置,其中所述突起为可伸长和可收缩的。
9.一种细胞悬浮液递送装置,其包含管状部件,所述管状部件具有纵向轴和径向轴、腔和外表面,所述管状部件具有一个或多个孔口,所述孔口具有足够直径以容许悬浮于液体介质中的细胞从所述腔穿过所述孔口,并且所述管状部件可灵活变形以将径向尺寸增大足够距离从而在引入所述装置的血管中产生斑块层的破裂。
10.根据权利要求9所述的细胞悬浮液递送装置,其中所述管状部件因位于所述血管中心的球囊膨胀而变形,所述球囊在膨胀时向所述装置施加力以使其与所述斑块层紧密接触。
11.根据权利要求9所述的细胞悬浮液递送装置,其中所述管状部件通过与所述装置呈可滑动关系的锥形部件所施加的机械力而变形。
12.根据权利要求9所述的细胞悬浮液递送装置,其中所述管状部件形成为在所述纵向轴的两个端部处接合的三维配置,其中所述端部通过施加滑线所传递的纵向力拉在一起或分开,这在将力沿第一方向施加到所述线时使所述装置在所述轴向方向上延伸,并且在将力沿第二方向施加到所述线时使所述装置在所述轴向方向上缩短。
13.根据权利要求9所述的细胞悬浮液递送装置,其进一步包含连接到所述装置的导管,所述导管具有与所述装置腔流体连通的腔。
14.一种用于治疗组织的方法,其包含以下步骤:
a.经由经皮进入将递送装置引入血管且安放所述递送装置非常接近于待治疗的组织;
b.以机械方式穿透非常接近于所述待治疗的组织的血管壁;
c.在压力下将一定数量的于悬浮液中的细胞递送穿过所述递送装置进入所述待治疗的组织中;以及
d.取出所述递送装置。
15.根据权利要求13所述的治疗方法,其中所述待治疗的组织为血管,所述方法包含以下额外步骤:
a.在安放所述递送装置之后,以机械方式使斑块层破裂或穿透斑块层;和在步骤b之后,
b.在压力下将一定数量的于悬浮液中的细胞递送穿过所述递送装置进入以下一者或多者:斑块、内膜、内膜下间隙、中膜、外膜或外膜周空间。
16.根据权利要求13所述的治疗方法,其中所述待治疗的组织为动脉瘤,所述方法包含以下额外步骤:
a.经由经皮进入将所述递送装置引入配对静脉且安放所述递送装置非常接近于所述配对动脉中的所述动脉瘤;
b.以机械方式穿透非常接近于所述动脉瘤的所述配对静脉的血管壁;和
c.在压力下将一定数量的于悬浮液中的细胞递送穿过所述递送装置进入非常接近于所述动脉瘤的所述动脉周围组织。
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PCT/US2017/000073 WO2018084882A1 (en) | 2016-11-02 | 2017-11-02 | Method and apparatus for delivery of cell therapies |
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US11116945B2 (en) | 2021-09-14 |
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