CN103491892B - 用于组织切除术的混合导管 - Google Patents
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Abstract
本发明提供了一种导管,其用于使不期望的沉积物从血管壁和位于血管中的支架中的至少一个的内表面减除,该导管具有末端部分,该末端部分包括:圆周定向的激光光学装置;以及圆形动作的切割机,其中所述圆周定向的激光光学装置被配置为传输用于改变不期望的沉积物的区域的激光辐射从而为所述切割机的穿透准备所述区域,其中所述切割机被配置为切掉所述改变区域且从而使不期望的沉积物的至少一部分减除。另外,公开了用于起搏器和ICD(植入型心律转复除颤器)导线取出的导管。
Description
技术领域
本发明涉及用于血管介入或其它介入的混合导管。
背景技术
外周和动脉血管疾病是常见的问题,其可直接导致发病和死亡。单独在美国,据估计,四百万以上的人遭受外周动脉疾病,在严重的病例中,外周动脉疾病利用外科手术或者甚至截肢来处理。
平坦性病变在胃肠病学中面临着重大的挑战。在大多数情况下,无柄息肉和扁平息肉(其可以与恶性肿瘤的高风险相关)的除去需要使用与用于除去普通息肉的那些技术不同的技术。这些技术可导致患者转诊到外科诊疗室而不是由胃肠病学家来除去。其它挑战性病变是非息肉性结肠肿瘤(NP-CRN)。巴雷特食管是另一种常见的慢性病症。美国人口中的患病率被估计为在成年人口的1-2%的范围内。巴雷特食管病症可导致严重的食管癌,据说其导致单独在美国每年12,000以上的死亡数以及在中国每年大约100,000的死亡数。
用于血管成形术、经皮腔内斑块旋切术和血栓切除术的基于激光和机械的解决方
案:
用于血管介入的激光消融技术的目前的技术现状是基于使用具有专用的导管的准分子激光器,诸如激光器和导管。这些技术例如描述于美国专利第6,673,064号、第7,811,281号和第7,572,254号中。由于技术和安全考虑,通常使用的准分子激光器常常是在308nm下操作的脉冲宽度在100纳秒范围内的氯化氙激光器。这些技术不是理想的并且具有一些限制。例如,当处理严重钙化斑块时,存在穿孔的风险以及来自碎片/斑块片段的损坏。因此,程序需要复杂的、大的并且昂贵的系统,并且程序的长度以似乎限定其广泛的临床效用的方式是相当重要的。另外,技术在处理大血管诸如SFA(股浅动脉)方面有困难,SFA在外周动脉疾病(PAD)的治疗中是非常重要的,其中直径大于4-5mm的血管以及长期病变必须被处理。
过程的长度的原因之一在于甚至最先进的解决方案之一(结合导管和TURBO激光Elite导管)也可能需要起始经皮腔内斑块旋切术来产生通过整个病变的起始导频信道的许多步骤,例如,利用单独的激光导管,并且仅仅在后期将激光导管载入导入护套中。导管的使用是基于几个通道,各自在导管旋转之后。参见 U,Zeller T,Tech Vasc Interv Radiol.2010Mar;13(1):43-53。
这种解决方案的另外的限制包括动脉碎片的无效除去以及动脉壁损伤的高风险,例如,如在美国专利第6,962,585号中所提到的:
由Spectranetics of Colorado Springs,Colo.提供的“准分子激光器冠状动脉血管成形术系统和程序涉及将包含一束光导纤维和具有导丝的支架的激光导管插入动脉中。激光导管在动脉中前进直到导丝穿过堵塞,这时紫外(冷)激光的爆发传播通过光纤以在堵塞中打开孔。其后,x射线染料被注射到血流中以确定动脉被打开的程度。这一程序没有除去大量的堵塞,因为紫外线辐射过于冷却以至于不能熔化堵塞。更确切地,孔爆炸通过堵塞以容纳支架进入。虽然导管系统包括过滤器,但是过滤器不足以捕获所有碎片,其可能流动到下游。
这样的先前的系统没有成功是因为它们没有从动脉壁有效地除去动脉堵塞,并且在动脉堵塞被移去之后没有从动脉中有效地除去动脉碎片。另外,这样的先前的系统没有使动脉壁充分地免受物理损伤和热损伤。此外,现有技术的设备中的很多包括许多部分,这些部分在高温/高真空环境中趋于失败或者粉碎。(同上,第1页,第19行)
美国专利第6,962,585号中公开了可选方法,其利用IR激光来热加热末端,该末端用于利用吸力切割待除去的斑块。这种方法可能遭受与基于非选择性加热的斑块除去相关的限制和风险。在这种情况下所提出的方法是在导管的外部部分中使用动脉鞘,其可限制导管的通道并且避免靠近壁。利用热效应的其它尝试包括混合热探针,其中激光能量(氩或Nd:YAG)的大部分被用于加热导管中的热的末端,并且其中的部分作为激光而脱离。临床结果没有满意地实现常规的临床用途。
另外的先前的方法包括利用激光来将斑块取芯并且利用机械装置来“摄取”并除去斑块。参见例如美国专利第4,979,939号。在加拿大专利第1,326,800号中,纤维被引入以产生开口,通过该开口引入末端旋转器,并且第二纤维被用于使由刀片收集的物质蒸发。美国专利申请公开第2010/0125253号公开了用于处理长期完全闭塞的双末端导管,纤维可以通过该双末端导管引入。
鉴于基于激光的技术的复杂性和限制性,基于准分子激光的系统在临床用途中具有限制的传播,并且研发了用于经皮腔内斑块旋切术的可选的机械方法,例如,其中斑块用旋转的金刚石包覆的刷(CSI产品)来“剃掉”(EV3产品)、“钻掉”(Pathway产品)或者“砂磨”。这些技术中的每一个常常可遭受固有限制,诸如程序长度、对血管的损伤、在某些情况下难以处理钙化斑块,并且相反地易于处理软斑块(参见 U,Zeller T,TechVasc Interv Radiol.2010Mar;13(1):43-53)或者将斑块物质清除进入血流。
应注意,该领域专家假定,健康组织的损伤以及在斑块被除去之后的组织的特征可影响治愈(以及初始增生)和再狭窄的速率,这似乎是以上提到的技术中的一些的限制。此外,鉴于利用很多现有技术来除去斑块的有限的能力,它们目前的效用主要限制为与在斑块被部分除去之后使用的低压球囊血管成形术结合使用。然后球囊利用剩余的斑块物质打开血管。
处理血管中完全或部分堵塞的需求还应用于人造移植物,诸如为了旁路植入腿中的、用于血液透析通路的以及更多的那些。
支架内再狭窄。本领域已知的是,在很大百分比的经历支架植入的患者中,在植入后的几年之内发生再狭窄。这是金属裸支架(BMS)的主要问题,并且甚至显示出强烈的再狭窄的降低的药物洗脱支架(DES)的引入仍然不能完全解决该问题。
血管的快速阻断。也存在对以最低的穿孔风险迅速打开遭受(由血管堵塞而引起的)缺血性中风或者心脏病发作的患者的血管的工具的需求。
起搏器和电震发生器的导线的除去。目前,由于如导线的破裂、绝缘的磨损引起短路和感染的一些原因,在患者的一部分中存在对起搏器和电震发生器的导线的除去的增长的需求。在世界各地大约有五百万导线被植入,并且据估计4-7%将不得不在某一时间点被除去。据估计,在2010年在美国和欧洲有100,000以上的导线被取出。
有一些方法用来除去经静脉引入的ICD导线。如果导线仅仅短期处于合适的位置,它们可通过简单的牵引而频繁地除去。在导线长期处于合适的位置之后,瘢痕组织可在牵引过程中保留导线,施加到导线的力通过绝缘线圈和导体线圈的抗拉强度来限制,因此,锁定口针(locking stylet)和护套用于实现更有力的拉伸,但是,当导线被附接到敏感组织如心肌壁时,成功的导线除去仍然是很成问题的。在一些情况下,导线的取出可能需要开放手术。Spectranetics准分子激光器和Cook医疗进化(Cook Medical’s Evolution)产品目前被用于利用经导管技术来除去导线。利用准分子激光器来使导线“减除”产生了良好的临床结果,但是需要大型的且昂贵的激光器,该激光器不允许在任何心脏病学装置中广泛使用,并且需要相对长的学习曲线。
存在对在患者中除去起搏器和电震发生器的导线的有效的并且安全的解决方案的需求。
巴雷特食管的治疗。巴雷特食管(BE)是常见的疾患,其是食管癌的主要风险因素。该疾患的患病率被估计为在1-2%的范围内。参见J,Aro P,Storskrubb T,等人的(2005年12月)“Prevalence of Barrett's esophagus in the general population:anendoscopic study”,Gastroenterology129(6):1825–31。严重范围可从早期到不同等级的异型增生到癌症。利用氩凝结物来治疗这种病症的先前的尝试产生了有争议的结果。可选的方法是基于RF消融(RFA)(系统)、光动力治疗(PDT)、冷冻疗法、热疗,或外科手术,如内窥镜黏膜切除术(EMR)。没有导致广泛的临床接受的方法,广泛的临床接受可在宽泛的人群中实现常规用途,而不是在疾病的早期“等待和观望”以及在更加严重状况下的包括食管切除术的特异疗法。
此外,由于并没有单一技术被确定为优选的方法,因此在某些情况下使用技术的组合。例如,存在RFA可用于患有BE和高度异型增生(HGD)的患者的舆论,BE和黏膜内癌为内窥镜黏膜切除术(EMR)的附属疾病(adjunct)。RFA用于具有低度异型增生(LGD)或肠化生的BE的用途没有被清楚地确定,参见David E.Fleischer_Virender K.Sharma,Interventional and Therapeutic Gastrointestinal Endoscopy.Front GastrointestRes.Basel,Karger,2010,第27卷,第140–146页。另一方面,EMR常常不允许除去所有巴雷特内层(Barrett's lining),但是在除去小癌或高度异型增生的局部区域中可以是成功的。因为其不能除去所有巴雷特内层,所以留下的巴雷特内层可形成高度异型增生或癌症的其它区域。因此,在除去残留的巴雷特组织的尝试中,EMR常常与光动力治疗结合,或者与RF消融结合。相反地,一些光动力治疗的研究还报道,一些患者具有如下情况,其中巴雷特内层没有完全消失,而是仍然在新的正常出现的鳞状内层的下面(并且当进行活组织检查时当显示出巴雷特内层的小面积仍然在新的鳞状内层的下面时被检测到)。在这样的情况下,利用另一种技术的另一种疗程可能是有利的。
当前的可用的技术的并发症包括穿孔(在食管中形成孔)、出血、狭窄、PDT的光敏性,以乃至死亡。
肠和胃中的复杂病变的除去。利用不同的成像技术利用增加百分率的结肠镜检查检测的息肉和腺瘤(良性肿瘤)不具有常规的“有蒂的”形状。没有通过狭窄的细长的梗附接到表面的息肉被称为无蒂的。不显著高于邻近黏膜的其它息肉被称为扁平的。因此,大的无蒂的和扁平的结肠直肠的除去比有蒂息肉的除去更难,并且在许多情况下需要利用特别的内窥镜检查技术来避免穿孔。
这些病变可以与高的临床风险相关联。具有黏膜下侵入的癌症的发病率似乎高于扁平侧向扩张肿瘤。
内窥镜黏膜切除术(EMR)成为用于大的无柄的和扁平的结肠直肠病变的切除术的标准技术。对于更复杂的病变,可以利用内窥镜黏膜下剥离术(ESD)。ESD可利用用于维持黏膜下提升的粘性注射溶液来进行,当息肉被切离固有基层时透热刀和塑料罩用来帮助缩回息肉。
虽然这些技术在结肠的任何位置是可行的,但是当前这些技术是技术上复杂的并且耗时的,并且ESD伴有主要并发症的相对高的比率。激光消融通常不被视为此应用的合适的解决方案,因为存在对确保病理学组织的充分的(即,完整的)除去的需求,并且优选地存在对收集用于组织学分析切除样品的需求。
因此,在本领域中存在对设备、系统和方法的未满足的需求,所述设备、系统和方法将允许高效并且有效的血管介入以及胃肠(GI)道中(主要在结肠和胃中)的复杂病变的除去以及巴雷特食管治疗。
妇科学和泌尿学中的复杂病变的除去。存在对在妇科学(子宫颈)和泌尿学(膀胱、前列腺)中除去病理学组织的有效的并且安全的工具的需求,其中切除深度可被控制,同时穿孔和出血的风险被降到最低。
发明内容
根据一些实施方案,提供了一种导管,其用于使不期望的沉积物从血管壁和位于血管中的支架中的至少一个的内表面减除(debulking),该导管具有末端部分,该末端部分包括:圆周定向的激光光学装置;以及圆形动作的切割机,其中所述圆周定向的激光光学装置被配置为传输激光辐射以用于改变不期望的沉积物的区域从而使所述区域为所述切割机的穿透作好准备,其中所述切割机被配置为切掉所述改变的区域且从而使不期望的沉积物的至少一部分减除。
根据一些实施方案,还提供了用于使不期望的沉积物从血管壁和位于血管中的支架中的至少一个的内表面减除的方法,该方法包括利用导管:利用圆周定向的激光光学装置照射不期望的沉积物的区域,从而改变所述区域;以及利用圆形动作的切割机切掉所述改变的区域,从而使不期望的沉积物的至少一部分减除。
根据一些实施方案,还提供了一种导管,其用于使不期望的沉积物从血管壁和位于血管中的支架中的至少一个的内表面减除,该导管具有末端部分,该末端部分包括:具有圆形横截面并且具有锋利的远端边缘的第一壁;以及沿着所述第一壁的表面定位的多根光导纤维,其中所述多根光导纤维被配置为传输激光辐射,该激光辐射被配置为改变不期望的沉积物且从而使不期望的沉积物为所述第一壁的所述锋利的远端边缘的穿透作好准备,其中所述第一壁被配置为切掉所述改变的不期望的沉积物且从而使不期望的沉积物的至少一部分减除。
根据一些实施方案,还提供了用于使不期望的沉积物从血管壁和位于血管中的支架中的至少一个的内表面减除的方法,该方法包括利用导管:利用具有多根光导纤维的导管,向不期望的沉积物传输激光辐射从而改变不期望的沉积物并且使不期望的沉积物为导管壁的锋利的远端边缘的穿透作好准备;以及使导管前进并且切掉改变的不期望的沉积物从而使不期望的沉积物的至少一部分减除。
根据一些实施方案,还提供了用于起搏器和ICD(植入型心律转复除颤器)导线取出的导管,该导管具有末端部分,该末端部分包括:具有圆形横截面并且具有锋利的远端边缘的第一壁;以及沿着所述第一壁的表面定位的多根光导纤维,其中所述多根光导纤维被配置为传输激光辐射,该激光辐射被配置为改变导线周围的组织从而使该组织为所述第一壁的所述锋利的远端边缘的穿透作好准备,其中所述第一壁被配置为切掉所述改变的组织且从而将导线与组织分离。
根据一些实施方案,还提供了用于起搏器和ICD(植入型心律转复除颤器)导线取出的方法,该方法包括:利用具有多根光导纤维的导管,向导线周围的组织传输激光辐射从而改变组织并且使该组织为导管壁的锋利的远端边缘的穿透作好准备;以及通过切掉导线周围的改变的组织且从而将导线与组织分离,使导管在导线之上前进。
根据一些实施方案,还提供了用于起搏器和ICD(植入型心律转复除颤器)导线取出的导管,该导管具有末端部分,该末端部分包括:圆周定向的激光光学装置;以及圆形动作的切割机,其中所述圆周定向的激光光学装置被配置为传输激光辐射以用于改变导线周围的组织从而使所述组织为所述切割机的穿透作好准备,其中所述切割机被配置为切掉所述改变的组织且从而将导线与组织分离。
根据一些实施方案,还提供了用于将不期望的组织与体腔的内壁分离的设备,该设备具有圆柱体的扇区的形状(shape of a cylinder's sector)的末端部分,该末端部分包括:多根光导纤维,其沿着末端部分的内表面定位并且被配置为将激光辐射传输到不期望的组织;以及切割机,其具有圆柱体的扇区的形状,该切割机向多根光导纤维的内部和/或外部定位,其中所述切割机被配置为切掉不期望的组织且从而使不期望的组织的至少一部分与体腔的内壁分离。
根据一些实施方案,还提供了用于将不期望的组织与体腔的内壁分离的方法,该方法包括:利用多根光导纤维,将激光辐射传输到所述不期望的组织的区域,从而改变所述区域;以及利用切割机切掉所述改变的区域,从而使所述不期望的组织的至少一部分分离。
在一些实施方案中,所述设备和所述内窥镜的纵向轴线之间的角度是根据所述不期望的组织的所需的剥离深度可调节的。
在一些实施方案中,切割包括利用沿着导管的圆柱形末端部分的内表面可旋转的刀片可旋转地切割。
在一些实施方案中,切割包括利用环形刀片可旋转地切割。
在一些实施方案中,切割还包括振动所述切割机。
在一些实施方案中,分离不期望的组织包括不期望的组织的剥离。
在一些实施方案中,机械削弱包括所述组织的消融。
在一些实施方案中,改变所述不期望的沉积物的所述区域包括机械削弱所述区域。
在一些实施方案中,改变所述组织包括机械削弱所述区域。
在一些实施方案中,改变所述不期望的沉积物包括机械削弱所述区域。
在一些实施方案中,所述圆周定向的激光光学装置包括沿着圆柱形末端部分的内表面定位的多根光导纤维。
在一些实施方案中,所述圆周定向的激光光学装置和所述圆形动作的切割机被配置为同时操作。
在一些实施方案中,所述圆周定向的激光光学装置和所述圆形动作的切割机被配置为间歇地操作。
在一些实施方案中,所述切割机包括在所述多根光导纤维的内部或外部沿着所述圆柱形末端部分的所述内表面可旋转的刀片。
在一些实施方案中,所述切割机包括在所述多根光导纤维的内部或外部沿着圆柱形末端部分的内表面或外表面定位的环形刀片。
在一些实施方案中,所述切割机被配置为具有两个位置,在第一位置中,所述切割机从末端部分的远端更远地延伸,并且在第二位置中,切割机向末端部分的近端部分缩回。
在一些实施方案中,所述切割机被配置为当高于预定值的力施加到所述切割机上时从第一位置移动到第二位置。
在一些实施方案中,所述切割机被配置为在指示施加到所述切割机上的力高于预定值时从第一位置移动到第二位置。
在一些实施方案中,所述切割机被配置为当高于预定值的力施加到所述切割机上时从第一位置移动到第二位置。
在一些实施方案中,所述切割机被配置为振动。
在一些实施方案中,所述切割机是所述导管的壁,其中所述壁具有锋利的远端边缘。
在一些实施方案中,所述药物包括:利用涂覆技术的CotavanceTM、TADD(来自Caliber Therapeutics,Inc.)、IN.PACTTMAmphirion、Coroxane或其任何组合。
在一些实施方案中,所述激光器是二极管泵钬纤维激光器(diode pump HolmiumFiber laser)。
在一些实施方案中,所述激光器是发射在2.8-3微米范围内的辐射的脉冲激光器。
在一些实施方案中,所述激光器是脉冲铥激光器。
在一些实施方案中,所述激光器是脉冲铥纤维激光器。
在一些实施方案中,所述激光器是Er:YAG激光器。
在一些实施方案中,所述激光器是被配置为以2.8-3微米发射的纤维激光器。
在一些实施方案中,所述激光器是脉冲激光器。
在一些实施方案中,所述激光器是固态三倍Nd:YAG激光器。
在一些实施方案中,所述激光辐射是脉冲辐射。
在一些实施方案中,所述一个或多个导线缩回元件被配置为仅仅当导管移动到身体的外面时抓住导线。
在一些实施方案中,所述一个或多个导线缩回元件包括球囊。
在一些实施方案中,所述多根光导纤维和所述切割机被配置为同时操作。
在一些实施方案中,所述多根光导纤维和所述切割机被配置为间歇地操作。
在一些实施方案中,所述多根光导纤维被配置为改变不期望的组织的区域从而使所述区域为所述切割机的穿透作好准备,其中所述切割机被配置为切掉所述改变区域且从而使不期望的组织的至少一部分分离。
在一些实施方案中,所述多根光导纤维沿着所述第一壁的内表面定位。
在一些实施方案中,所述多根光导纤维沿着所述第一壁的外表面定位。
在一些实施方案中,所述多根光导纤维包括一根或多根具有大于其远端直径的近端直径的光导纤维。
在一些实施方案中,所述第二壁包括锋利的远端边缘。
在一些实施方案中,所述末端部分是圆柱形的。
在一些实施方案中,所述末端部分是可扩展的。
在一些实施方案中,导管还包括药物洗脱球囊。
在一些实施方案中,导管还包括在所述末端部分的远端处的光集中器。
在一些实施方案中,导管还包括第二壁,其中所述多根光导纤维位于所述第一壁和所述第二壁之间。
在一些实施方案中,导管还包括一个或多个成像元件,其被配置为提供关于所述血管的内部部分的信息。
在一些实施方案中,导管还包括用于监测程序的一个或多个成像元件。
在一些实施方案中,导管还包括一个或多个成像元件,其被配置为提供关于所述血管的内部部分的信息。
在一些实施方案中,导管还包括一个或多个导线缩回元件。
在一些实施方案中,导管还包括用于施用药物的一个或多个开口。
在一些实施方案中,圆周定向的激光光学装置包括沿着导管的圆柱形末端部分的内表面定位的多根光导纤维。
在一些实施方案中,设备还包括在所述末端部分的远端处的光集中器。
在一些实施方案中,设备还包括一个或多个成像元件,其被配置为提供关于所述腔的内部部分的信息。
在一些实施方案中,设备还包括用于施用药物的一个或多个开口。
在一些实施方案中,设备还包括用于冲洗洗涤液的开口或管件。
在一些实施方案中,设备被配置为用于胃肠道、泌尿学或妇科学。
在一些实施方案中,设备被配置为安装在内窥镜的末端部分上。
在一些实施方案中,方法还包括施用用于预防或治疗再狭窄的药物。
在一些实施方案中,方法还包括冲洗洗涤液。
在一些实施方案中,方法还包括对所述腔的内部部分进行成像。
在一些实施方案中,方法还包括对程序进行成像。
在一些实施方案中,方法用于胃肠道、泌尿学或妇科学的腔内程序中。
在一些实施方案中,不期望的组织包括平坦性病变,且其中胃肠道腔包括胃的内壁。
在一些实施方案中,不期望的组织包括平坦性病变,且其中胃肠道腔包括胃的内壁表面。
在一些实施方案中,不期望的组织包括无柄息肉、扁平息肉和NP-CRN(非息肉性结肠肿瘤),且其中胃肠道腔包括结肠的内壁表面。
在一些实施方案中,不期望的组织包括巴雷特组织,且其中胃肠道腔包括食管,其中所述末端部分被配置为与食管的典型的解剖学匹配。
在一些实施方案中,不期望的组织包括巴雷特组织,且其中胃肠道腔包括食管。
在一些实施方案中,传输激光辐射和切割是同时进行的。
在一些实施方案中,传输激光辐射和切割是间歇进行的。
附图说明
在参考附图中图示了示例性的实施方案。为了呈现的方便和清楚而一般地选择附图中显示的部件和特征的尺寸,并且不必按比例显示。下面列出了附图。
图1A以透视图显示了混合导管的示例性的圆柱形末端部分;
图1B以前视图显示了混合导管的示例性的圆柱形末端部分;
图1C以横截面图显示了具有部分斑块堵塞的血管内部的混合导管的示例性的圆柱形末端部分;
图2显示了相对于图1A-C具有一个或多个改变的混合导管的示例性的末端部分;
图3A显示了包括中空反射光集中器的末端部分;
图3B显示了包括固态光集中波导管的末端部分;
图3C-3E显示了锥形纤维的使用;
图4A-4B显示了圆形动作的切割机;
图5显示了可扩展的末端部分的横截面图;
图6A-B图示了引入通过导管并且以一系列喷嘴或孔结束的管600;
图7A-B图示了使用辊700来着色组织;
图8A-B图示了构造在导管的壳体中的孔800;
图9A-B图示了用于施用药物的一系列管或针900a-b;
图10显示了安装在内窥镜上的混合设备的示例性的末端部分;
图11显示了在分离不期望的组织的程序过程中安装在内窥镜上的混合导管;
图12显示了组装在市售的内窥镜上的导管;以及
图13A-13C显示了在将被取出的导线之上的混合导管的横截面。
具体实施方式
一些实施方案的一方面涉及混合导管及其在内腔介入中的使用方法。例如,当前实施方案在多种血管应用中可能是有用的,诸如经皮腔内斑块旋切术、血管成形术、支架内再狭窄中的斑块的减除、导线的取出、慢性外周动脉疾病和冠状动脉疾病的血栓切除术,以及用于治疗冠状的和神经血管应用中的血管的急性堵塞。另一个实例是在胃肠病学的实施方案中的用途,诸如,用于除去GI道中的无柄的和扁平的病变、巴雷特食管的治疗,以及用于妇科学和泌尿学介入中需要从内壁中除去组织的类似的应用中。
混合导管可以基于激光和从体腔中将不期望的物质机械除去(还称作“减除”)的组合。在血管介入中,导管可被配置为利用激光削弱和/或甚至切割并且分离不期望的物质,且然后甚至在斑块物质没有完全被除去的情况下,通过机械装置诸如利用刀片分离斑块物质的剩余部分。激光可改变组织的机械特性,且从而提高机械工具诸如各种类型的刀片或刮刀的性能。通过实施例的方式,激光可以使软组织易碎,以便其可利用机械工具有效地压碎。
有利地,该导管的使用可避免光消融(蒸发)不期望的物质的大部分或全部的需要。相应地,该过程可以比常规的激光消融更快并且产生更少的副产物,较少相关的机械应力以及较少的其它副作用诸如由光消融导致的热损伤。该过程可允许利用更少的激光,其中能量集中在更小的区域,且其中机械工具除去留在处理区域中的痕迹并且便于激光束的进一步穿透以进行有效的消融。另外,复杂的钙化组织可被成功地处理,尽管在当今的普遍的机械或准分子激光器的许多中用来微妙地分离这样的组织与血管壁的困难。该导管有利地提供了对血管壁最低损伤或无损伤的斑块的控制切割。
本文公开的混合导管可以单独使用(例如,在经皮腔内斑块旋切术中)和/或与低压球囊血管成形术的支架结合使用,用于在支架无损伤的情况下治疗支架内再狭窄,和/或用于治疗由于斑块或血栓引起的急性堵塞(血栓切除术)。
术语“切割”、“解剖”、“切除”、“分离”、“减除”和“除去”在此可交换地使用。
根据一些实施方案,导管包括末端部分,其可以是基本上圆柱形的形状,具有圆周定向的激光光学装置,所述圆周定向的激光光学装置任选地为一根或多根光导纤维的形式,被配置为递送激光辐射;并且具有圆形动作的切割机,所述圆形动作的切割机包括一个或多个刀片,所述刀片被配置为帮助从血管的内表面切割和/或分离不期望的物质(还称为“沉积物”)。一根或多根光导纤维可以是圆周定向的,也就是,它们可以沿着靠近末端部分的周边的圆柱形末端部分的内表面定位。可选地,圆周定向的光导纤维可以定位在别处,但是通过定向和/或光学聚焦的方式定向,以辐射末端部分的圆周的前面的区域。
圆形动作的切割机可位于末端部分的中心部位,例如,由光导纤维围绕。可选地,圆形动作的切割机可位于末端部分的周边并且一根或多根光导纤维位于末端部分的中心部位,例如,由刀片围绕。
根据一些实施方案,一根或多根光导纤维以及一个或多个刀片位于末端部分的周边。
根据一些实施方案,一根或多根光导纤维以及一个或多个刀片位于末端部分的中心部位。
根据一些实施方案,圆形动作的切割机位于弹簧上以便由切割机施加的最大力被预先确定以避免可能的损伤,但仍是有效的。末端部分可包括内部通道,所述内部通道维持在相对低的压力以吸出可能是斑块的不期望的物质、血栓物质、碎片、用于清洁的盐溶液和/或类似物。
任选地,提供电机以使圆形动作的切割机旋转以便改善片段切割和/或分离。另外或可选地,该电机或不同的电机可被用于快速振动圆形动作的切割机以便改善片段切割和/或分离。
任选地,圆形动作的切割机被加热以改善其性能。这可通过外部加热源、电气装置和/或通过激光消融来完成。
根据一些实施方案,导管的末端可以是可扩展的,使得其直径可在其引入到血管中之后增加。
根据一些实施方案,导管的末端可包括用于偏向的装置,使得有效的工作区域将大于导管的直径并且能够离轴工作。
根据一些实施方案,导管在长期完全闭塞(CTO)的情况下可以是有用的,其中,因为导丝的使用常常指定某一相对位置,且尤其是导管的末端部分对比血管的角度,导丝不能正常地用于通过完全堵塞血管的病变,且因此经皮腔内斑块旋切术常常是不可行的。
一些实施方案中的合适的激光器的实例是发射大约355nm和/或266nm的脉冲的固态紫外(UV)激光器。合适的激光器的实例是在50Hz下发射50mJ的355nm的10ns脉冲和/或在40Hz下发射40mJ的266nm的10ns脉冲的Qauntel CFR400。另一个实例是准分子激光器。
在使用显著高重复频率的情况下,组织中的热效应可能成为一个问题。这可通过将消融区域(深度和宽度)最小化、使用短激光脉冲以及盐水冲洗来至少部分地解决。另一个选择包括以不使全部纤维同时暴露于激光定量(laser ration)的方式连续照明纤维,以便实现受影响的组织的热弛豫。
在一个实施方案中,染料或基底可被用于在某些波长下(诸如,355nm)增强吸收。例如,在程序之前用血咔啉(haematoporphrin)或四环素敏化,以便增强预先处理的动脉粥样硬化斑块的消融而不是不敏感的或正常的动脉壁的消融。
一些实施方案中的激光器的另一个实例是在中红外(IR)区域中发射脉冲辐射的激光器,诸如在2.8-3微米的范围内,其中水非常有效地被吸收的范围。另外或可选地,可以使用在大约2微米处的辐射,其中优选在1910-1940nm的范围发射的铥激光,其中存在优选与Q开关调节(Q-switched modulation)结合的水的更高的吸收,其中消融是更有效的且降低了侧向损坏。对于3微米发射,可使用Er:YAG,或者另一种源,诸如直接泵激二极管激光的中红外钬纤维激光器,其利用氟化物纤维在2840nm处发射[参见Optics Letters,2007年9月1日,第2496-2498页]。
又一个实例是在355nm下使用Nd:YAG激光器的三次谐波,优选地是紧密的全部固态的二极管泵激激光器。与308nm辐射相比,在相关组织和物质的100微米或更多的深度范围内355nm辐射通常具有更深的穿透能力。任选地,使用非常短的脉冲宽度(诸如<10ns),以获得更高的能量密度,并且具体地,以便能够是钙化的斑块消融。根据一些实施方案,每脉冲能量在10-100mJ的范围内,并且脉冲频率在10-100Hz的范围内。任选地,消融的区域可以用盐溶液冲洗以降低副作用(诸如气血现象),清洁消融的区域和导管和/或便于碎片的收集。
利用355nm辐射的优势之一是其被认为是相对非诱变的。氯化氙激光器的308nm辐射在UVB范围内,已知其具有诱变风险。[Walter Alexander.Journal of Clinical LaserMedicine&Surgery.AUGUST1991,9(4):238-241.doi:10.1089/clm.1991.9.238.]
一些先前的研究已表明,与308nm激光相比,三次谐波激光由于较长的穿透率和消融的较低的效率一般较不适合于血管内介入(参见,例如,Grundfest WS等人,Am JSurg.1985年8月;150(2):220-6;和Frank Laidback等人,Lasers in Surgery andMedicine8:60-65(1988))。然而,当前实施方案可成功地利用三次谐波Nd:YAG激光器代替复杂且昂贵的准分子激光器。当前实施方案解决了一些问题。例如,在一些实施方案中,可能不必激光消融期望除去的全部物质,而是激光器和机械切割机可以分担任务;激光器可使物质中的一些消融和/或削弱,而机械切割机通过使物质与壁最终分离而完成工作。
在一些实施方案中,可以使用发射266nm辐射的激光器。这一波长具有较短的穿透率,另外,如当前所使用的,在308nm下发射的紧密的准分子激光器可以与当前的实施方案一起使用。根据一些实施方案,系统可包括使操作者能够在由相同的Nd:YAG激光器产生的266nm和355nm之间切换的装置,以及控制功率、重复率和/或特定纤维组的暴露/照明的装置。
本发明的可选的实施方案用2微米或2.8-3微米的辐射的激光器代替UV激光器,其中消融是非常有效的。
钬激光器常规地用于2微米,但是铥激光器具有更强的吸水率和更小的吸收长度,这使其尤其适合于一些实施方案。例如,在一个实施方案中,使用脉冲纤维铥激光器。可选地,可使用固态激光器以增加每脉冲的脉冲功率,目前其在纤维激光器中是受限制的,并且鉴于受限制的脉冲率,固态激光器可被使用以便使热积聚和损坏降到最低。
2.8-3微米内的激光器可以是Er:YAG。具有数百纳秒范围内的脉冲的Q-开关Er:YAG是可用的,其可适合于当前实施方案。参见,例如,M.Skorczakowski,等人LaserPhysics Letters第7卷,第7期,第498–504页,2010年7月。可适合于特定实施方案的另一个激光器的实例是以几百KHz发射mJ范围内的微秒脉冲的Pantec’s模型DPM-15固态激光器。
在一个实施方案中,使用可直接二极管泵激的纤维激光器,诸如中红外钬纤维激光器。这种激光在约1150nm的辐射下可从基准水平(5I8)泵激到受激的能带(5I6),并且在弛豫到基态时弛豫带可导致在2840nm(弛豫到带5I7)和2100nm下的发射。相应地,这种激光可利用近期开发的高功率、高亮度的基于在1148nm下产生输出的高应变的InGaAs量子阱的二极管激光器直接泵激。参见Optics Letters,2007年9月1日,第2496-2498页以及StuartD.Jackson Optics Letters,第34卷,第15期,第2327-2329页(2009)。
激光器可根据所选择的共振器光学装置来选择,例如,发射在2.9-μm跃迁(transition)(5I6到5I7)的激光辐射的氟化物纤维激光器,和发射在2.1-μm跃迁(5I7到5I8)的辐射的二氧化硅纤维激光器。利用2.9-3微米的区域内的激光的实施方案的优势在于,吸收是非常高的,并且导致仅仅15微米量级的非常短的吸收长度。因此,弛豫时间是较短的,以便脉冲率可以增加到100Hz以上以使程序加速。
除了与不期望的物质相互作用的激光束之外,具有控制脉冲率和/或功率的激光器可用于与纤维尖头(激光束的出口)和组织之间的液体相互作用,以允许在与组织的需要的相互作用之前以及邻近(adjunctive)时,束的通道(例如,其中当使用UV辐射时光不被吸收的通道)对组织“开放”,和/或以便于得益于“喷水”效果的过程(当使用中红外辐射时)。通过阐明,末端可以与被消融或未被消融的组织机械接触。
现在参照图1A、1B和1C,其分别以透视图、前视图和横截面图显示了根据示例性的实施方案的混合导管的示例性的圆柱形末端部分100。在一些实施方案中,导管的轴(未显示)的剩余部分可以是任选涂覆的生物相容的聚合物管,以使与血管壁的摩擦降到最低。
部分100定位在混合导管的远端,该端插入血管中。末端部分100可包括壳体102,例如,圆柱形壳体;至少一根光导纤维104,其沿着壳体102的内表面定位;以及圆形动作的切割机(或者简称“切割机”)106,其定位在光导纤维的内部。可选地,在一个实施方案中(未显示),圆形动作的切割机可定位在光导纤维的外部。旨在将以下实施方案的描述(其中圆形动作的切割机定位在内部)应用(加以必要的变更)到可选的未显示的实施方案。任选地,光导纤维104由第一内壁108界定和/或支撑。进一步任选地,切割机106由第二内壁110界定和/或支撑。
根据一些实施方案,导管与标准导丝一起使用。
根据一些实施方案,导管被连接到抽吸泵,所述抽吸泵产生低压以通过导管收集不期望的物质、盐水和/或类似物。泵可以是蠕动泵,其外部地安装到流体路径,以避免泵的任何污染。任选地,这排除了使用一次性部件的需求。
作为此混合导管的激光光学装置的光导纤维104可在其近端(未显示)连接到以上面所列参数中的一个或多个为特征的激光源。光导纤维104可从源向身体的介入位点递送激光束。在图1C的末端部分100中,光导纤维104被显示为它们向不期望的物质114发射激光。不期望的物质114中的一个或多个区域116可因此被改变或者甚至通过激光而消融。然后,切割机106可更加容易地切入不期望的物质114中并且使其至少一部分与血管壁118分离。
切割机106任选地是环形刀片,所述环形刀片延伸到末端部分100的内部的一定深度并且耦合到合适的电机(未显示),所述电机位于末端部分或者进一步位于轴中,对刀片提供旋转和/或振动动力。任选地,一个或多个柔性构件诸如弹簧112可以在其基底处与切割机相互作用,以允许其从壳体102缩回和伸长。图1A-C的末端部分100被显示为切割机106处于其伸出位置,而图1C的末端部分100b被显示为切割机(现在标记为106b)处于其缩回位置。当处理血管时,伸出壳体102的长度可以是例如多至约350微米。当伸出时,切割机106被用于将不期望的物质(也称为“沉积物”)114与血管120的内表面118分离。根据一些实施方案,当一定的力(例如,高于预定的值)从前面施加到切割机106时,其可能是血管120的堵塞的结果,切割机可移动其位置并缩回到壳体102中。
切割机106的环形刀片可具有足够薄的边缘,诸如大约100微米。合适的刀片可以是由诸如MDC Doctor Blades、Crescent和UKAM的公司特制的。刀片可以任选地安装在旋转的可旋转管的末端。这样的管可获自诸如Pilling的制造商,其提供激光仪器和刀片制造的路线。刀片可以是金属或者通过模制诸如塑料的材料来制造,其任选地涂覆了具有用于体内使用的适当特征的涂层。
示例性的末端部分可具有大约5mm的外径,大约3.4mm的内径(在最内层之内,其是切割机或另外的壁),并且光导纤维各自具有大约0.1-0.2mm的直径。
现在参照图2,其显示了混合导管的示例性的末端部分200,其可类似于图1的末端部分100并具有一个或多个改变:首先,存在于末端部分200中的光导纤维的一根或多根纤维222可用于通过将反射光和散射光从腔的内部输送到位于身体外部的外观视图和/或分析设备(未显示)来使血管220的腔成像。这可帮助避免血管220的穿孔并允许介入过程的在线监测。第二,末端部分200可以是容易操作的,以允许不同的视图角度和/或以便使激光束和切割机206有差别地匹配。第三,清洁通道(未显示)可存在于末端部分200的内部并且在身体的外部延伸,通过清洁通道施加通道吸力224以便排出被激光和/或切割机206处理了的不期望的物质的碎片。现在更加详细地讨论这些任选的可选方案。
用于检测斑块和其它病变以及用于监测血管处理的常规的方式是基于超声和荧光镜检查。然而,在此,一根或多根纤维222可用于基于来自血管和/或沉积物的激光的反射和/或散射来检测病变和/或在线监测介入过程。另外或可选地,可以使用照明的不同来源,诸如通过一个或多个其它纤维。被捕获的光可被传递到诸如CCD、CMOS或MOS的传感器。传感可包括过滤器或用于光谱成像的装置,以获得关于物质特征的信息(斑块、组织、钙化斑块、血块,等等)。这可以最低的穿孔风险实现快速的且有效的程序,并且可实现其中导丝不能或不应被使用的减除程序。
末端部分200的角度可被控制以通过末端偏向在比导管大小大的横截面上实现物质的除去。这可通过机械工具来完成,诸如通过以不同角度外部地附接到末端部分的至少两个球囊(未显示)或者具有不同隔室226a-d的球囊的选择性充气和放气来完成。另一个实例是使用形成结合点228的连结物,其是利用一个或多个线(未显示)从身体的外部可控制的。
现在将更加详细地讨论一些实施方案的激光光学装置。激光束可以通过纤维来定向,所述纤维各自具有任选地在40-250微米的范围内的芯直径。在其中导管的周长是例如15mm的构型中,使用外径为50微米的纤维将导致使用横截面积小于1mm2的大约300根纤维,以便对于75%的耦合效率,当用50mJ激光泵激时,每根纤维的出口处的能量接近于40mj/mm。对于一些实施方案的合适的纤维可以是具有纯二氧化硅芯的全二氧化硅纤维。这些纤维通常可经受约5J/cm2的输入。一些实施方案包括数值孔径(NA)在0.12-0.22的范围内的纤维。相关纤维的实例是用于UV应用的FiberTech Optica’s SUV100/110AN纤维和与1900-2100nm范围内的激光或红外线纤维系统、IR光子和用于传递在2900-3000范围内的辐射的A.R.T.光子GmbH纤维一起使用的低OH型SIR100/140AN。可实现单一方式或多方式的实施方案,而光束品质的保持是重要的,但是在某些实施方案中不是强制的。一些实施方案可在末端区域处包括显微透镜以在每个单根纤维的出口处操纵束。
利用355nm的10nsec脉冲的有效消融所需要的功率(大约30-60mJj/mm2)接近于某些纤维的损坏阈或高于损坏阈,这导致现有产品中的例如延长的脉冲长度的需求。根据一些实施方案,高的峰值功率得到保持,并且相应地,导管可包括通过相对较大的光导纤维(例如,并不是一直延伸到末端部分的末端的100或甚至300微米的纤维)递送激光功率的装置,如图3A-3E中示意性图示的。
图3A显示了末端部分300,其包括具有笔直轮廓或内弧轮廓(未显示)的中空反射光收集器304a,其用于从至少两根纤维(在304处共同显示)收集光。中空收集器406a可具有基于金属的或绝缘的涂层。中空收集器304a可以如下方式形成围绕切割机306的环形状:来自全部纤维的辐射由一个收集器递送,以便在出口处产生脉冲辐射的相对均匀的环。出口可包括窗(在图中未显示)。任选地,光路可利用盐水的冲洗来维持清洁。冲洗可通过在导管和额外的腔之间的前面的开口或来自侧面的开口,所述额外的腔也可便于导管在血管中的移动,或者在某些实施方案中,通过中心腔。
图3B显示了末端部分330,其包括用于收集来自至少两根纤维(以304共同显示)的光的固态光收集波导管334a。固态波导管334a可以例如由具有反射涂层的二氧化硅制成,或者由诸如二氧化硅和掺杂氟化物的二氧化硅的两种材料的组合制成。
固态波导管334a可以任选地在界面处覆盖纤维,以改善从纤维到集中器的光通量。可选地,两者可以是焊接的。
图3C-3E图示了锥形纤维的使用,诸如可获自Oxford Electronics的那些。纤维可以在导管的轴的近端处是厚的340,并且在其远端是薄的342—如横截面所见的。图3E以透视图显示了单根锥形纤维340a。
现在参照图4A,其显示了根据一个实施方案的圆形动作的切割机的另一种选择。在此,圆形动作的切割机可以是例如利用柔性轴460可旋转的旋转刀片406,所述柔性轴460使周边地连接到旋转刀片的板462中心地旋转。柔性轴460可以具有递送有限量的扭矩的能力,尤其是当动脉中存在弯曲等时。一般的机械的经皮腔内斑块旋切术的设备有时利用非常高的旋转速度来对其补偿。当前实施方案减少了对高力矩的需求,因为刀片在已准备的区域中是活动的,也就是—切割或者至少通过激光来改进。此外,施加到粥样斑/斑块的较低的扭矩和旋转力的事实减小了施加到血管的径向力。
现在参照图4B,除了旋转刀片406被旋转的方式以外,图4B大概类似于图4A。旋转刀片406可通过微型电机464和合适的传输装置466来旋转。合适的微型电机可获自诸如Namiki的制造商,其开发了1.5mm直径的微小齿轮传动的DC电机。
任选地,图4A-4B的旋转刀片406可具有便于收集和/或刮削减除的物质的形状,以便于碎片的收集。
为了能够使血管有效地减除,可使用例如在4-22French范围内(大约1.3-7mm)的不同尺寸的导管。较大的导管的使用保持了增强介入过程的优势,但是提出了介入血管中所需的大的开口和/或血管本身的可接近性的问题。因此,根据一些实施方案,至少在其末端部分的导管的直径可以是可扩展的。第一实例显示于图5中,其是可扩展的末端部分500的横截面图。与导管的轴的剩余部分相比,末端部分500的壳体502可由相对柔性的材料制成。当导管到达减除部位时,末端部分500扩展以形成外锥形的形状。这种扩展可通过引入机械元件来实现,所述机械元件对末端部分500的一个或多个部分施加压力。然后传输激光束的纤维504可插入导管壁中。因为当末端部分500扩展时,纤维之间的距离也延伸,更多的纤维可被插入壁中。任选地,被引入用来使末端部分500扩展的机械元件包括切割机506。任选地,可扩展的末端部分500可以与图2中的末端部分减除装置结合使用。
在具有可扩展的末端部分的导管的另一实施方案中,可使用形状记忆材料,诸如镍钛(被称为镍钛合金)。导管或者至少其末端部分在引入身体中之前被压缩,并且在其被引入腔之后自然地恢复到其预压缩的形状。镍钛合金可用于网或编织物的结构,以提供足够的径向力,同时当导管缩回时能够用足够低的径向力收缩。一些柔性可仍然保持在末端部分,以允许适应腔的生理形状。末端还可包括用于控制偏向的装置。
在一些实施方案中,导管可进行药物的局部递送,所述药物减少了再狭窄事件,诸如紫杉醇及其衍生物,或者可溶形式诸如Coroxane。药物可在治疗后保持在该部位,并且帮助腔恢复,同时防止剂量过量和系统效应。
在从血管或支架除去不期望的材料之后的药物施用可通过诸如以下的方法来实现:(i)由导管的外表面的喷嘴喷涂药物,或者用贯穿导管中的合适的通道的管喷涂药物,所述管在其末端包括一系列喷嘴;(ii)通过将组织“喷漆”的辊;(iii)通过药物涂覆的球囊;(iv)通过球囊,所述球囊包括将药物递送通过其壁中的通道的装置;(v)在导管壁上刷;(vi)具有喷嘴的管,所述喷嘴可改变其进出物质除去部位的路径的方向。
为了优化长期效力,一些实施方案提供用于药物的深度施用的方法,所述药物保持在动脉壁的更深层中或者保持在残留的斑块中,但是没有保持在内皮中,从而允许新的内皮细胞生长并且与腔重新匹配,在腔修复和重新内皮化之后抑制深层细胞层的再狭窄。这可通过诸如压力控制药物的施用、表面下面的施用和/或适当药物形式的选择的方法来完成。
为了增加斑块物质的吸收,处理程序可包括增加在335nm下斑块的吸收的一种或多种物质的施用,诸如用四环素处理,斑块对四环素的摄取比正常组织对四环素的摄取大几倍。参见,例如Murphy-Chutorian D等人,Am J Cardiol.1985年5月1日;55(11):1293-7。
对于血管的处理,常常期望在更深层的动脉壁中而不是内皮中施用药物,从而允许新的内皮细胞生长并且重衬腔。因此,在腔修复和重新内皮化之后药物继续抑制深层细胞层中的再狭窄,而另一方面,消除了剂量过量和系统效应。在一些情况中,一些板块物质保留在血管壁或支架上,并且应当考虑药物剂型和施用方式。
可应用的药物的实例包括:利用涂覆技术的CotavanceTM、TADD(来自Caliber Therapeutics,Inc.)、 IN.PACTTMAmphirion、Coroxane,等等。
为了避免再狭窄而施用这些药物的常规方式是利用涂覆的球囊。可选的药物形式诸如Coroxane可在程序后迅速地通过IV施用,但是这将不会产生局部施用。在文献中已提出进行两步骤过程,其中经皮腔内斑块旋切术之后利用涂覆的球囊,但是这将导致可限制日常临床用途的更加复杂的并且昂贵的程序。
图6A-B、7A-B、8A-B和9A-B包括适合于药物的局部施用的许多示例性的末端部分的实施方案的示意图。
图6A-B图示了引入通过导管并且以一系列喷嘴或孔602结束的管600,所述一系列喷嘴或孔602根据需要喷涂药物。
图7A-B图示了使用辊700来着色组织。导管可包括如下装置,所述装置允许辊在减除程序之前至少部分地到达槽702的内部,并且当需要将药物转移到组织时离开槽。辊700可包括如下装置,所述装置对壁施加压力以增加药物递送和/或在支架内再狭窄(ISR)应用中扩展支架。
图8A-B图示了构造在导管的壳体中并且仅仅在需要时被配置为打开的孔800。
图9A-B图示了用于以将增加其持续性的方式施用药物的一系列管或针900a-b。提供了这样的装置,其允许在减除程序之前和之后和/或以从腔/支架的内部和外部的方式使管相对于导管的角度发生改变。当管向前移动时,管可以面朝前面900a,当管向后移动时,管可以是面朝后面900b。管任选地由柔性的生物相容的材料制成。
药物施用的另外的实例可包括:通过导管的壁中的接头转移药物的刷;用于施用药物的球囊;围绕导管并且涂覆有药物并且在减除程序之后充气的球囊;具有接头的球囊,所述接头被用于根据需要来施用药物;以及插入通过导管的清洁通道的涂覆的球囊。
本文公开的实施方案作为实施例而呈现并且可为了以下应用中的血管介入的目的而结合:在慢性和急性病症中的外周冠状的和神经血管的应用中,以及在胃和泌尿学中支架不得不清洁的其它医学应用中,以及腔不得不被创造或延伸的应用诸如良性前列腺增生中。
根据本发明的一些实施方案,另一个临床应用是在腔内程序过程中从体腔中除去不期望的组织。这样的程序可以例如在妇科学、泌尿学和胃肠病学中进行。这样的程序包括例如除去胃肠(GI)道中以及巴雷特食管的治疗中的扁平的和/或大的病变。动机是以最低的并发症除去不期望的病理学组织(例如,在巴雷特食管的病例中,没有食管穿孔和狭窄)。这种临床应用可需要本文所公开的根据一些实施方案的混合导管的改进的实施方案。图10-图12图示了根据本发明的一些实施方案的用于使不期望的组织与体腔的内壁分离(例如,但不限于巴雷特食管的治疗)的导管。
第一实施方案是一种混合导管,其结合激光辐射的效用,以使不期望的病理学组织消融并且切割/分离不期望的病理学组织,或者改善其机械特性和机械装置诸如刀片或导管的壁的锋利的边缘以完成分离。这样,利用激光辐射和刀片/壁的边缘进行组织割除/切除。因此,刀片/壁的边缘不需要太锋利且从而刀片/壁的边缘被配置为切割组织而没有可能的穿孔或对体腔的损坏的风险。
现在参照图10,其以透视图显示了根据示例性的实施方案的安装在内窥镜1500上的混合设备的示例性的末端部分1000。在一些实施方案中,导管的剩余部分,也就是—其轴(未显示)是任选涂覆的生物相容的壳体,以降低与腔壁的摩擦。内窥镜1500可以是任何市售的镜,所述镜尤其具有用于插入医学工具的工作通道1502、用于清洁和吹入的水/空气注射器1504,以及照明器1506。内窥镜1500还可包括照相机1508和光学装置,所述照相机1508包括例如CCD、CMOS或MOS。
末端部分1000定位在混合导管的远端,该端插入体腔诸如食管中。末端部分1000具有圆柱体的扇区的形状并且通常被配置为安装在内窥镜的顶部(例如,如上部内窥镜或肠镜中所使用的)。末端部分1000的形状还被配置为与其意图插入的体腔的典型解剖学匹配。当然,混合导管(设备)的末端部分可具有其它合适的形状和形式,并且在某些实施方案中可安装到用于操纵其的另外的工作工具上,而过程由诸如腹腔镜检查程序中的另外的照相机来监测。末端部分1000可包括两个壁,外壁1002和内壁1004。这些壁(外壁1002和内壁1004)中的一个或者这两者可具有锋利的远端边缘以便于切掉不期望的组织。这些壁(外壁1002和内壁1004)中的一个或者这两者可涂覆了提供更锋利的边缘的材料。至少一根光导纤维,通常是多根光导纤维1006被定位在外壁1002和内壁1004之间。可选地,在一个实施方案中(未显示),可以仅仅存在一个壁,并且光导纤维可沿着其内表面和外表面定位。可选地,在一个实施方案中(未显示),可以存在切割机(类似于图1A-C中所示的仅仅具有圆柱体的扇区的形状的切割机)。在另一实施方案中,外壁1002、内壁1004和/或切割机(刀片)可具有两个位置,缩回位置和伸出位置(被配置为用于切割)。
外壁1002、内壁1004和/或切割机(刀片)被配置为(诸如由于锋利度)切掉不期望的组织且从而使不期望的组织的至少一部分与体腔的内壁分离。如果存在刀片,其可以是旋转动作的刀片和/或振动刀片。根据一些实施方案,光导纤维1006被配置为传输激光辐射,所述激光辐射被配置为改变不期望的组织的区域,从而为外壁1002、内壁1004和/或切割机(刀片)的穿透准备所述区域。
根据一些实施方案,刀片可安装在弹簧中,以便当施加的力超过某一预定水平时刀片进入其隔室(移动到缩回位置)。可选地,在另一实施方案中,刀片的位置可由医师来控制。这样,在没有激光的情况下刀片是不够锋利的,不足以切割组织以避免可能的穿孔。在导管的边缘处的盐水或另一种合适的溶液的冲洗可用于保持清洁的光路,除去不必要的材料并降低可能的热损伤并且利用中红外辐射源的“喷水”效果。
现在参照图11,其显示了根据一些实施方案的在分离/割除(“剥离”)不期望的组织的过程中安装在内窥镜上的混合导管。混合导管1001包括末端部分1000,传输激光辐射并且切掉组织。在该图中,混合导管1001被用于除去巴雷特组织1008。图示显示了不同层可被靶向并且除去。巴雷特组织1008(或任何其它不期望的组织)通过导管切割并且运送。导管诸如导管1001可以(不必)组装在市售的内窥镜诸如内窥镜1600上。根据一些实施方案,(特别是但不限于)GI道中介入的混合导管的末端部分可被定位在相对于镜轴线的预定的角度,且从而根据所需要的剥离深度预定穿透的深度。
“剥离”样方式可被认为是“木工刨”的类比,但是使用“混合刀片”。剥离的深度可根据临床情况诸如巴雷特除去的深度或者根据疾病的阶段以及类似的在GI道的其它位置中的平坦性病变中所需要的深度来调整。相应地,刀片的刀的位置以及刀片和平面之间的距离可被调整。具有混合刀片的导管可位于预定的角度/位置并且可位于离内窥镜或用于保持末端的另外的工具的平面预定的距离。在这个实施方案中,导管可用于进行组织的初始切割,同样,一些激光脉冲用于实现切口的产生以允许刀片切掉需要的层且然后在镜的帮助下根据导管的位置角在器官之上在向前或向后的方向上移动导管。
根据一些实施方案,导管插入通过标准内窥镜的工作通道或者通过专用镜做出的特定开口。一些实施方案包括利用具有记忆形状的末端,其收缩以便引入通过工作通道,并且当其离开内窥镜末端时其扩展。这样的导管可以基于镍钛合金的使用。这些实施方案使医师能够进行诊断程序,并且如果发现病理,则引入割除导管。
在另一实施方案中,根据病理,激光波长可被选择为实现降低的组织穿透或表面消融,诸如355nm或2.8-3微米的激光或者更深的266nm的激光。为了深入组织的相互作用,本发明的实施方案包括使用中红外激光,其具有更长的穿透深度。铥激光器(可能是铥纤维激光器,λ=1908-1940nm,其中波长根据实施方案而匹配以补偿取决于温度的吸水率的波长改变)可用于这一应用中,因为与钬:YAG相比其具有与大约2微米的长度的吸水率的更好的匹配,并且相应地穿透深度被限制于几百微米,并且与没有热损伤的钬相比脉冲率也可增加。
使用“混合导管”来从诸如GI道的腔减除需要的组织的可能的优势之一是激光的副作用并且这增强了体内平衡并且避免了出血。根据所使用的特定的激光,效果可能不足以避免出血,并且一些实施方案可包括为了止血的目的使用额外的激光,其优选地通过相同的光导纤维来递送。
根据一些实施方案,导管被连接到抽吸泵,所述抽吸泵产生低压以通过导管收集不期望的物质、盐水和/或类似物。泵可以是蠕动泵,其外部地安装到流体路径,以避免泵的任何污染。任选地,这排除了使用一次性部件的需求。
混合导管还可用于改进活组织检查程序以使相对大的样品能够被选择用于进一步的组织学分析,且从而减小抽样误差,其与患有BE的患者的高风险或者妇科学和泌尿学应用有关。
根据一些实施方案,混合导管可进一步包括成像装置以检测不得不被处理的需要的区域并且在线监测该过程,从而根据从早期诸如没有异型增生的巴雷特食管到具有最低并发症的更高级的疾病的疾病严重度实现有效的“局部疗法”,因为其限制对周围健康组织的损坏并且避免黏膜穿孔。类似的考虑可以应用于妇科学和泌尿学应用中。获得工作区域的图像的装置可包括例如商业纤维镜如Medit INC F2.4(30,000像素的2.4mm45度FOV)或Olympus LF-2(为气管插管而设计),所述商业纤维镜可插入5mm的管中并且包括1.5mm的通道以便于流体的吸入/滴入,提供>3mm的90度视野,因此纤维可相应地放置。如上文中所讨论的,混合导管可以与商业内窥镜(诸如优选地是胃镜)结合使得具有增强的成像能力,如窄带成像(NBI)以利用更高的分辨率检测病理学区域。例如,可使用Olympus GIF-H180J型(或等同物),其在远端具有9.9mm的直径,因此混合导管可以以其可被合宜地引入身体的方式被附接到壁。这实现了四向成角(210°上,90°下,以及100°右/左),140°视野以及特写的高分辨率图像可在离组织2mm近时获得,因此激光刀片导管可相应地被附接到镜的末端(在前面相对前进几毫米)。
根据一些实施方案,本文提供了混合导管,其具有末端部分,所述末端部分具有用于传输(脉冲)激光辐射的光导纤维以及具有面的内壁和/或外壁,所述面足够锋利以完成由激光器起始的导线的切割和减除(取出),但是不够锋利,不足以单独工作,以维持程序的安全。利用混合导管允许降低来自激光器的需求,且因此能够以使得当导线的减除没有通过激光器完成时,围绕导线的组织的切割(通过锋利的壁和/或通过刀片)机械地进行的方式使用小的固态激光器。
现在参照图13A-C,其显示了用于起搏器和ICD(植入型心律转复除颤器)导线取出的三种类型的混合导管的横截面图示。
图13A显示了将被取出的导线2000之上的混合导管2002的横截面。导管2002具有末端部分2004,通常具有圆形横截面。末端部分2004包括内壁2006和外壁2008,其中至少一个具有锋利的(例如锥形的)远端,因此其用作刀片。光导纤维2010位于内壁2006和外壁2008之间并且被配置为将激光辐射运输通过末端部分2004的远端(如由箭头所标记的)。激光辐射改变(例如,消融、部分地消融、削弱、切割等等)导线周围的组织且从而为内壁2006和外壁2008的锋利的远端边缘的穿透准备该组织,使得壁被配置为切掉改变的组织且从而使导线2000与组织分离。
根据一些实施方案,导管可包括容纳导线的装置以便将其从身体中取出。这些实施方案目标在于代替本领域中已知的复杂的过程,其中插入导线锁定设备(例如,Spectranetics导线锁定设备)且然后插入用于激光消融的另一个导管(Spectranetics II)。根据一些实施方案,用于容纳并且缩回导线的装置的两个实例示意性地图示在图13B和图13C中。
图13B显示了将被取出的导线2000之上的混合导管3000的横截面。导管3000可以类似于导管2002,但是还包括连接到混合导管3000的内壁的“环形状的”球囊(3002/3004)。当混合导管3000穿透导线2000周围的组织时球囊放气(3002)。当混合导管3000被拉出以便取出导线2000时球囊充气(3004)并且“固定”导线2000且因此帮助其取出。
图13C显示了将被取出的导线2000之上的混合导管4000的横截面。导管4000可以类似于导管2002,但是还包括“抓取元件”4002,其被配置为允许导管4000光滑地穿透导线2000周围的组织,但是当移动到外部时以预定的力固定导线2000。根据一些实施方案,导管可包括在存在需要不带导线而缩回导管的情况下用来释放这种固定的装置。
在本申请的说明书和权利要求书中,词语“包括(comprise)、包括(include)”和“具有”中的每一个及其形式不必限于可与该词语相关的列表中的构件。另外,当在本申请和通过引用方式参考或并入的任何文件之间存在矛盾时,据此意图由本申请控制。
Claims (8)
1.一种用于将不期望的沉积物从血管壁、位于血管中的支架和体腔中的至少一个的内表面减除的导管,所述导管包括末端部分,所述末端部分具有基本上圆柱形的形状,所述末端部分包括:
圆周定向的激光光学装置,其包括多根光导纤维,其中所述多根光导纤维沿着所述末端部分的内表面定位;以及
圆形动作的切割机,其定位在所述末端部分的远端处,
其中所述圆周定向的激光光学装置被配置为传输用于消融所述不期望的沉积物的区域的激光辐射从而使所述区域为通过所述圆形动作的切割机进行减除作好准备;且其中所述圆形动作的切割机被配置为切掉所消融的区域且从而使所述不期望的沉积物的至少一部分减除。
2.如权利要求1所述的导管,其中所述末端部分被配置为与其意图插入的所述体腔的典型的解剖学匹配。
3.如权利要求1所述的导管,其中所述圆形动作的切割机是所述末端部分的壁。
4.如权利要求3所述的导管,其中所述末端部分的壁具有锋利的远端边缘。
5.如权利要求1所述的导管,其中所述圆形动作的切割机包括在所述多根光导纤维的内部或外部沿着所述末端部分的内表面或外表面固定的环形刀片;或者,其中所述圆形动作的切割机包括在所述多根光导纤维的内部或外部沿着所述末端部分的所述内表面可旋转的刀片。
6.如权利要求1所述的导管,其中所述圆周定向的激光光学装置是脉冲激光器、固态三倍Nd:YAG激光器、脉冲铥激光器、脉冲铥纤维激光器、Er:YAG激光器或二极管泵钬纤维激光器。
7.如权利要求1所述的导管,其中所述圆周定向的激光光学装置是纤维激光器或脉冲激光器,且其中所述圆周定向的激光光学装置被配置为发射在2.8-3微米范围内的激光。
8.如权利要求1所述的导管,其中所述不期望的沉积物包括无柄息肉、扁平息肉和非息肉性结肠肿瘤,且其中所述体腔包括结肠的内壁表面;或者其中所述不期望的沉积物包括平坦性病变,且其中所述体腔包括胃的内壁;或者其中所述不期望的沉积物是巴雷特组织,其中所述体腔包括食管且其中所述末端部分被配置为与所述食管的典型的解剖学匹配。
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