CN109414292A - 用于切除和/或消融不需要的组织的装置和方法 - Google Patents
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Abstract
本文提供了一种用于从受试者的身体切除不需要的组织的导管,导管包括呈圆柱或圆柱扇区形状的顶端部分并具有中心纵向轴线,顶端部分包括:中心纵向腔;第一组光纤,用于在平行于中心纵向轴线的方向上将激光辐射传输到顶端部分的远端末端外部;第二组光纤,用于相对于中心纵向轴线横向地传输激光辐射;其中第一组光纤和第二组光纤可选择性地操作以切除和/或消融不需要的组织。
Description
技术领域
本公开的实施方案涉及用于组织切除的装置、系统和方法。
背景技术
射频消融(RFA)是一种利用电能热消融肿瘤细胞的微创医疗手术。类似地,使用微波能量激光进行激光消融。
由于易碎的胰腺实质、对胰腺炎的恐惧和胰酶的外渗,通过引发组织坏死的热消融对胰腺中的肿瘤和其它疑似病变的治疗已知是有问题的,因为健康周围组织的附带损伤可能是非常危险的。这与控制不同解剖学结构中的冲击和使热冲击难以预测的组织的异质性以及需要避免损伤血管、十二指肠等的挑战一起限制了诸如射频(RF)和微波消融的工具的实用性。报告的胰腺RFA并发症包括胃肠道出血、胰瘘、胆漏、门静脉血栓形成、胰腺假性囊肿和败血症。类似地,已经报道了许多的肝脏中图像引导的热消融的并发症,例如出血、肠和胆管损伤、血管血栓形成和肝梗死、胆管狭窄等。
有人试图找到新的用于内镜超声EUS引导消融的解决方案。尝试使用利用光纤的胰腺组织的Nd:YAG消融显示出一些希望但影响有限。
常规技术的另一个限制是获得活体组织切片以分析胰腺、肝脏等中的病变。足够的样本可以对病变/周围组织进行可靠的组织学分析、遗传分析等。现有技术工具的一个限制是收集足够大的样本而没有出血和/或扩散肿瘤细胞的风险。在肝肿瘤治疗领域中已知用于消融肿瘤和/或收集可靠的活检样本的技术的类似风险和限制。
当肿瘤还小的时候,尝试检测肿瘤。可以治疗肝脏和胰腺中在几厘米范围尺寸的肿瘤,并且如果有效切除和消融的同时使附带损伤最小化,则可以改善患者的预后。因此,本领域需要使用直径为几毫米的导管的安全有效的消融技术。
相关技术的前述示例和与其相关的限制旨在是说明性的而非排他性的。在阅读说明书以及研究附图之后,相关领域的其它限制对于本领域技术人员将变得明显。
发明内容
结合系统、工具和方法来描述和说明以下实施方案及其方面,这些系统、工具和方法旨在是示例性和说明性的,而非限制范围。
根据一些实施方案,提供了一种用于从受试者的身体切除不需要的组织的导管,导管包括呈圆柱或圆柱扇区(cylinder's sector)形状的顶端(tip,或称为尖端)部分并具有中心纵向轴线,顶端部分包括:中心纵向腔;第一组光纤,用于在平行于中心纵向轴线的方向上将激光辐射传输到顶端部分的远端末端外部;第二组光纤,用于相对于中心纵向轴线横向地传输激光辐射;其中第一组光纤和第二组光纤可选择性地操作以切除和/或消融不需要的组织。
根据一些实施方案,第一组光纤和第二组光纤可以根据不需要的组织的图像独立地和/或可选择性地操作。
根据一些实施方案,第一组光纤可以用于切除在第一组光纤前方的组织以到达需要被移除的组织。
根据一些实施方案,第二组光纤中的每根光纤或每个光纤子集可以根据不需要的组织的图像是独立地和/或分别地可控的,以便选择性地消融不需要的组织或其部分。
根据一些实施方案,导管可进一步用于促进以允许其实验室测试的形式提取切除的不需要的组织或其部分。
根据一些实施方案,第一组光纤可以沿着并平行于中心纵向轴线定位,并且延伸到顶端部分的远端末端。
根据一些实施方案,第二组光纤可以沿着并平行于中心纵向轴线定位,并且近侧延伸到顶端部分的远端末端。
根据一些实施方案,导管还可以包括切割器,该切割器包括用于切割不需要的组织的一个或多个刀片,其中切割器定位在从第一组光纤和第二组光纤传输的激光辐射的光路之外。切割器可以由顶端部分的壁的远端边缘形成或者固定到顶端部分的壁的远端边缘。切割器的壁可以具有尖锐的远端边缘。
根据一些实施方案,激光辐射可以是脉冲辐射。
根据一些实施方案,第一组光纤可操作地联接(couple)到第一激光器,第二组光纤可以可操作地联接到第二激光器和/或激光二极管。
根据一些实施方案,第二组光纤可以可操作地联接到多路复用激光器,该多路复用激光器用于以不同的波长、强度和/或脉冲频率发射激光辐射。
根据一些实施方案,提供了一种用于从受试者的身体切除不需要的组织的系统,该系统包括:导管,导管包括呈圆柱扇区形状的顶端部分并具有中心纵向轴线,顶端部分包括:中心纵向腔;第一组光纤,用于在平行于中心纵向轴线的方向上将激光辐射传输到顶端部分的远端末端外部;和第二组光纤,用于相对于中心纵向轴线横向地传输激光辐射;和处理器,用于基于在切除不需要的组织之前和/或期间获得的不需要的组织的位置和/或3D图像,选择性地控制至少由第二组光纤传输的激光辐射的至少一个参数。根据一些实施方案,至少一个参数可以包括波长、功率、强度、脉冲频率或它们的任何组合。
根据一些实施方案,处理器还可以用于选择性地激活第二组光纤中的每根光纤或每个光纤子集。处理器还可以用于确定导管的行进速度/速率。
根据一些实施方案,该系统还可以包括提取机构,用于促进以允许不需要的组织的实验室测试的形式提取切除的不需要的组织或其部分。
根据一些实施方案,该系统还可以包括至少可操作地联接到第二组光纤的多路复用激光器。
根据一些实施方案,该系统还可以包括可操作地联接到第一组光纤的第一激光器和可操作地联接到第二组光纤的第二激光器。
根据一些实施方案,该系统还可以包括可操作地联接到第一组光纤的第一激光器和可操作地联接到第二组光纤中的光纤的至少两个激光二极管。
根据一些实施方案,该系统还可以包括切割器,切割器包括用于切割组织的一个或多个刀片,其中切割器定位在由第一组光纤和第二组光纤传输的激光辐射的光路之外。
根据一些实施方案,该系统还可以包括切割器,切割器包括用于切割组织的一个或多个刀片,其中切割器由对从第二组光纤发射的辐射透明的材料制成。
根据一些实施方案,提供了一种用于从受试者的身体切除不需要的组织的方法,该方法包括:利用具有纵向轴线的导管以及第一组光纤和第二组光纤,通过第一组光纤将激光辐射传输到不需要的组织的第一区域,从而引起其非热消融和/或切除,其中辐射在基本平行于纵向轴线的第一方向上传输;通过第二组光纤将激光辐射传输到不需要的组织的第二区域,从而引起其热消融或非热消融,其中来自第二组光纤的辐射在第二方向上传输,第二方向不平行于第一方向;并且其中由第二光纤传输的激光辐射的至少一个参数是可控的。该方法还可以包括利用定位在导管上的切割器切割穿过不需要的组织,从而切除至少一部分不需要的组织。根据一些实施方案,传输第一激光辐射和切割可以同时进行。根据一些实施方案,传输第一激光辐射和切割可以间歇进行。
根据一些实施方案,该方法还可以包括获得不需要的组织的图像(例如,3D图像)。
根据一些实施方案,该方法还可以包括基于对不需要的组织的图像的解释来选择性地激活第二组光纤中的每根光纤或每个光纤子集。
根据一些实施方案,至少一个参数可以包括波长、功率、强度、脉冲频率或它们的任何组合或任何其它参数。
根据一些实施方案,该方法还可以包括以允许不需要的组织或其部分的实验室测试的形式提取切除的不需要的组织。
根据一些实施方案,该方法还可以包括使导管通过不需要的组织内的路径或接近不需要的组织的路径或组织内的路径行进,以便到达不需要的组织。
在说明书和附图中可以找到本发明及其实施方案的更多细节和特征。
除非另外定义,否则本文使用的所有技术和科学术语具有与本发明所属领域的普通技术人员通常理解的相同的含义。尽管与本文描述的那些类似或等同的方法和材料可以用于本发明的实践或测试,但下文描述了合适的方法和材料。如有冲突,专利说明书、包括定义进行控制。另外,材料、方法和示例仅是说明性的而不是旨在限制。
附图说明
示例性实施方案在参考图中示出。通常选择图中所示的部件和特征的尺寸是为了方便和清楚地呈现,而不一定按比例示出。本文公开的实施方案和附图旨在被认为是说明性的而不是限制性的。下面列出了附图:
图1示意性地示出了根据本发明示例性实施方案的改进的光纤;
图2示意性地示出了根据本发明另一示例性实施方案的改进的光纤;
图3A是根据本发明的示例性实施方案的导管的圆柱形顶端部分的横截面侧视图;
图3B和3C是根据本发明的示例性实施方案的图3A的圆柱形顶端部分的远端视图;
图4A是根据本发明的示例性实施方案的导管的圆柱形顶端部分的透视图;
图4B是根据本发明的示例性实施方案的图4A的圆柱形顶端部分的横截面侧视图;
图4C是根据本发明的示例性实施方案的图4A的圆柱形顶端部分的剖视图;
图5是根据本发明示例性实施方案的用于切除和/或消融不需要的组织的方法的步骤的流程图。
图6A-B是说明根据本发明的示例性实施方案,使用导管从猪胰腺切除病变而没有附带热损伤的照片;
图6C是说明根据本发明的示例性实施方案,使用图6A和6B的导管机械提取的组织的照片;
图6D是说明根据本发明的示例性实施方案,使用图6A和6B的导管通过真空提取的组织的照片;
图7A和7B分别是根据本发明的示例性实施方案,通过激光切除和热坏死的组合引起的坏死胰腺组织的显微照片和照片;
图8是说明根据本发明的示例性实施方案的猪胰腺组织的照片,猪胰腺组织包括通过非热辐射处理的区域和通过热辐射处理的区域;以及
图9是一段鸡胸肉的照片,示出了通过非热辐射处理的区域和通过热辐射处理的区域。
具体实施方式
本文公开了用于从受试者的身体切除不需要的组织(例如病变或肿瘤)的装置、系统和方法。有利地,根据一些实施方案,本文公开的装置、系统和方法可以用于从身体器官(例如胰腺和肝脏)切除不需要的组织(例如病变或肿瘤)。
一些实施方案的一方面涉及导管和使用该导管切除身体器官中的病变或肿瘤的方法。可以通过血管、天然腔(例如胃肠道、泌尿系统或阴道)、经皮方法、通过腹腔镜的工作通道或通过内窥镜的工作通道将导管引入身体器官内的目标部位。此外,导管可以利用激光能量、机械力及其组合穿过特定器官、血管等的壁,以到达目标部位。例如,本发明的实施方案可以用于到达病变并且能够使用非热消融和机械装置切除病变以切割穿过组织,同时引起对病变的周围组织的最小附带损伤。根据一些实施方案,非热是用于定义消融的术语,其中组织通常通过脉冲激光被消融,其方式是组织被改变或移除,而没有在吸收的能量热扩散到周围环境之前由于高功率辐射与组织和其改变的相互作用的性质而导致的附带热损伤。
任选地,导管可以用于切除器官(例如胰腺和肝脏)中的病变。进入胰腺中的病变可以通过胃肠(GI)腔,使得通过胰管进入,在ERCP手术中从胆总管进入或在EUS引导下通过胃进入。任选地,可以选择通过血管(例如胰腺动脉之一)进入肿瘤的位置。在肝脏肿瘤的治疗中,优选的实施方案可以通过经皮方法,如通常用于经皮肝脏活检那样进行。
在一些实施方案中,本发明的目的是允许在穿过病变的单个路径中在外周中进行切除和受控消融。通过将辐射发射到周围的预定部分(例如圆形切口)来进行受控消融。在一些实施方案中,可以通过围绕导管顶端的微电极进行消融,并且可以使用电力进行消融。
导管的可操作性可以基于人(医师)和/或机器人操作。消融的控制可以基于人和/或计算机。任选地,可以将导管连同监测装置一起操作。可以在导管操作之前、期间和/或之后操作监测装置。监测装置的非限制性示例包括:光谱、热感测、声学监测(例如监测气泡/噪声)、成像、PET CT、造影CT和内窥镜超声(EUS)。
任选地,控制单元可以根据基于目标部位/器官的成像/监测计算的信号来调节以下各项:激光波长、激光功率和导管的行进速度。
根据一些实施方案,导管可以是混合导管,其包括能量装置(例如激光)和机械装置(例如刀片)。任选地,导管可以用于用激光削弱和/或甚至切割和分离不需要的组织,然后通过机械装置(例如使用刀片)分离其余组织。可以将导管进一步用于以允许实验室测试(例如病理学、组织学和/或其它相关测试)的形式收集分离的组织。任选地,还可以将导管用于辅助移除提取的组织(例如,通过导管的纵向腔或通过另一个腔/通道/孔口),然后使得提取的组织被收集并被送到实验室进行进一步的测试,例如组织学或其它类型的分析,进一步的测试可以在手术期间进行,以通过(例如使用冷冻活检)检测肿瘤边缘等来优化临床有效性和安全性。
任选地,导管还可以包括用于收集通过导管腔提取的样本的机械装置。
混合导管的操作可以基于在导管的行进路径内从身体器官非热激光辐射消融和机械移除不需要的组织的组合。任选地,能量装置可以用于在围绕导管的行进路径的区域中进一步引起热坏死和/或非热消融。这能够减轻与导管穿过肿瘤相关的风险,这种风险可能导致肿瘤细胞扩散,这已知是肝脏活检中的重大风险;和/或导致增加坏死影响的横截面超过导管的横截面积。
激光可以改变组织的机械特性,从而改善机械工具(例如各种类型的刀片(blade)或刮刀(shaver))的性能。举例来说,激光可以使软组织更脆,因此可以使用机械工具有效地压碎它。本发明的导管有利地提供了病变的受控消融和组织的收集,同时对周围组织的附带损伤最小。
有利地,混合导管的使用可以导致比常规激光消融更少的副产物、更小的相关机械应力和更少的其它副作用(例如由光消融引起的热损伤)。该方法可以允许使用较小的激光器,其中能量聚焦在较小的区域,其中机械工具移除残留在经过处理的区域中的痕迹并且有助于激光束的进一步穿透以进行有效的消融。
根据一些实施方案,术语“切割”、“解剖”、“切除”、“分离”、“减除(debulk)”和“移除”在这里可以互换使用。
根据一些实施方案,术语“不需要的组织”可以指任何需要移除和/或进一步检查的可疑组织。
根据一些实施方案,导管包括切除顶端,该切除顶端具有第一组光纤和第二组光纤,第一组光纤用于非热激光辐射的前照明,促进导管前方的组织的非热消融或凝固,第二组光纤用于非热激光辐射的侧面照明,促进对导管成角度或侧向的组织的非热消融或凝固,和/或促进引起对导管成角度或侧向的组织热坏死的热辐射。任选地,通过激光波长、功率和导管行进速度来控制坏死和/或凝固的深度和广度。任选地,切除顶端包括切割边缘。
根据一些实施方案,导管包括顶端部分,该顶端部分可以基本上呈圆柱形,沿中心纵向轴线延伸,并具有:中心纵向腔;第一组光纤,第一组光纤可操作地联接到激光器并用于传输能够引起目标组织的非热消融的激光辐射(“第一激光辐射”或“非热激光辐射”)。激光辐射可以沿着与中心纵向轴线平行的轴线传输到顶端部分的远端末端外部。顶端部分有利地还包括第二组光纤,第二组光纤可操作地联接到激光器并用于传输用于引起第一激光辐射的目标组织附近的组织的热和/或非热消融的激光辐射(“第二激光辐射”或“非热和/或热激光辐射”)。根据一些实施方案,例如根据周围组织的特性(例如,其对器官功能的重要性和/或其对热损伤的敏感性),可以选择性地控制由第二激光辐射引起的消融和/或损伤的广度。任选地,顶端部分还包括切割器,切割器包括用于切割组织的一个或多个刀片。
导管还可以连接到抽吸泵,抽吸泵产生低压以通过导管(例如通过顶端部分的中心纵向腔)收集切割的组织。泵可以是蠕动泵,其连接到患者体外的导管的近端部分。
任选地,提供控制单元以调节以下各项:来自第一组光纤的非热辐射的传输,来自第二组光纤的非热和/或热辐射的传输,以及根据从目标部位的监测装置计算的信息导管穿过目标部位的进程。
术语“光纤”是指可以通过在光纤内的光的内部反射将光从一端传递到另一端的线。光纤可以是包覆的或非包覆的。包覆的光纤通常具有从中心到外围的结构,包括芯、包覆层和缓冲层。没有包覆层的非包覆的光纤通常具有暴露的芯。芯可以由任何透明材料(例如二氧化硅(玻璃)或透光的聚合物)制成。在包覆的光纤中,芯通常被但不限于薄塑料或二氧化硅包覆层包围,薄塑料或二氧化硅包覆层有助于以最小损耗将光传输通过光纤。包覆层可以覆盖有坚韧的树脂缓冲层。芯和包覆层都可以由介电材料制成,介电材料例如但不限于为掺杂的石英玻璃和聚合物。为了将光信号限制在芯中,芯的折射率通常大于包覆层的折射率。
第一组光纤的光纤可以用于远离光纤的远端末端以平行于光纤芯的中心纵向轴线的方式分布辐射。在这种实施方案中,第一组光纤可以沿圆柱形顶端部分的内表面周向定位,第一组光纤靠近顶端部分的周边或中心。任选地,将第一组光纤嵌入顶端部分的壁内并平行于中心纵向轴线定位,使得激光辐射远离顶端部分的远端末端平行于顶端部分的中心纵向轴线传输。
可选地,周向定向的光纤可以定位于别处,但是通过定向和/或光学聚焦引导,以平行于顶端部分的中心纵向轴线的方式辐射远离顶端部分的周边的区域。
第二组光纤的光纤可以用于从光纤芯横向地分布辐射。为此,可以将光纤进行改进用于横向分布,例如通过切割或抛光光纤包覆层或化学抛光或机械削刮包覆层,如在双包覆层光纤中。根据一些实施方案,第二组光纤可以包括2至16、4至12、4至8根光纤。每种可能性都是单独的实施方案。根据一些实施方案,第二组光纤可以包括至少四根光纤。根据一些实施方案,光纤可以分布在顶端部分周围预定的周向位置处。作为非限制性示例,至少四根光纤中的一根可以相对于另一根偏移预定的角度,例如围绕顶端部分每90度或每45度偏移。
根据一些实施方案,术语“横向地”可以指不平行于导管的中心纵向轴线的任何方向。例如,基本上垂直于中心纵向轴线的方向,或者沿着与中心纵向轴线具有约10°至170°的角度的任何轴线的方向。
用于横向和/或角度照明的改进的光纤的非限制性示例示于图1和2中。图1是用于横向和/或角度照明的改进的光纤104b的侧视图。改进的光纤104b包括由包覆层162围绕的纵向芯160。光纤104b的远端164被切割/抛光,例如以约30度的角度,移除包覆层162的远端部分以暴露纵向芯160,从而促进光如虚线箭头所示沿角度/横向方向的侧向散射。
图2是用于横向和/或角度照明的另一种改进的光纤204b的侧视图。改进的光纤204b基本上类似于图1的改进的光纤104b,并包括由包覆层262围绕的纵向芯260。值得注意的是,将光纤204b的远端264以比图1的光纤104b的远端部分更大的角度切割/抛光,以引起由虚线箭头指示的90度的光的内部删除和折叠。任选地,光纤204b还配备有保护元件266,用于保护远端264免受机械损坏和/或用于阻挡前指向光束,并避免与表面接触而进行的内部反射。任选地,锥形光纤(未示出)可以单独使用或与反射表面(未示出)一起使用。任选地,可以添加漫射器(未示出)以增加光发散,或者可选地,可以使用聚焦元件来获得更局部的相互作用。在一些实施方案中,经过抛光/切割的顶端可以涂覆有反射涂层以促进光束反射/偏转。
任选地,第二组光纤可以沿着圆柱形顶端部分的内表面定位。任选地,将第二组光纤嵌入在顶端部分的壁内并平行于中心纵向轴线定位并靠近顶端部分的远端末端,使得激光辐射远离顶端部分的远端末端相对于顶端部分的中心纵向轴线横向地传输。另外地或可选地,激光辐射可以通过顶端部分(靠近其远端开口)的壁、例如通过壁中形成的光学窗口传输。
任选地,可以将第一组光纤和第二组光纤共同嵌入顶端部分的壁内。
任选地,切割器是圆形动作切割器。圆形动作切割器位于第一和第二激光辐射的光路之外。圆形动作切割器可以位于顶端部分的中心部分,例如,由第一组光纤和第二组光纤围绕。可选地,圆形动作切割器可以位于顶端部分的周边,第一组光纤可以位于顶端部分的中心部分(例如由刀片围绕)。在非限制性示例中,第一圆形切割器位于由第一组光纤围绕的顶端部分的远端末端的中心部分中,第二圆形切割器位于顶端部分的远端末端的周边处,而第二组光纤位于顶端部分的周边,靠近其远端末端。
根据一些实施方案,以下至少一个:一个或多个刀片以及第一组光纤和第二组光纤位于顶端部分的周边。根据一些实施方案,一个或多个刀片以及第一组光纤和第二组光纤中的至少一组位于顶端部分的周边。根据一些实施方案,第一组光纤和第二组光纤以及一个或多个刀片位于顶端部分的周边。
根据一些实施方案,第一组光纤、第二组光纤以及一个或多个刀片位于顶端部分的中心部分。根据一些实施方案,以下至少一个:第一组光纤、第二组光纤以及一个或多个刀片位于顶端部分的中心部分。根据一些实施方案,一个或多个刀片以及以下至少一组:第一组光纤和第二组光纤位于顶端部分的中心部分。
根据一些实施方案,圆形动作切割器放置在弹簧上,使得由切割器施加的最大力是预定的,以避免潜在的损坏,而还是有效的。顶端部分可以包括保持在相对低压下的内部通道,以吸入不需要的材料(例如肿瘤组织)。
任选地,提供马达以使圆形动作切割器旋转,以便改善碎片切割和/或分离。另外地或可选地,可以使用该马达或不同的马达使圆形动作切割器快速振动,以便改善碎片切割和/或分离。任选地,加热圆形动作切割器以改善其性能。这可以通过外部热源、电气装置和/或激光辐射来完成。
根据一些实施方案,导管顶端可以是可扩张的,使得其直径可以在其被引入目标部位之后增加。根据一些实施方案,导管顶端可以包括用于偏转的装置,使得有效工作区域大于导管直径并且能够进行离轴工作。
任选地,第一组光纤和第二组光纤中的每一组独立地可操作地连接到激光器。第一组光纤和第二组光纤可以可操作地连接到不同类型的激光器和/或相同类型的激光器。任选地,高功率脉冲激光器可以用于非热消融或凝固,连续波(CW)激光器用于引起热坏死。用于引起热坏死的激光器的示例包括Nd:YAG,绿色激光器,980nm,铥和钬激光器。根据一些实施方案,功能上连接到第二组光纤的激光器可以是多功能激光器,即能够以不同波长、强度和/或脉冲发射激光辐射的激光器。因此,多功能激光器能够以选择性控制的方式(例如根据用户选择的选择模式和/或根据例如基于在治疗之前接收的目标组织的图像自动确定的操作模式)发射激光辐射。根据一些实施方案,第二组光纤可以连接到能够发射预定激光辐射的激光二极管。根据一些实施方案,第二组光纤可以连接到多于一个激光二极管,每个二极管能够发射预定的激光辐射。这种配置使得能够基于多于一个激光二极管中的某些激光二极管的选择性激活以选择性控制的方式发射激光辐射。激活可以由用户确定和/或例如基于在治疗之前接收的目标组织的图像自动确定。
用于非热消融的激光束可以被引导通过光纤,每根光纤具有任选在40至250微米的范围内的纤芯直径。在导管周长为例如2mm的构造中,在导管周边的两个圆周处使用外径为70微米的光纤,将导致使用约110根横截面积小于1mm2的光纤,因此对于50%的耦合效率,当用80mJ激光器泵浦时,每根光纤出口处的能量将接近40mJ/mm。对于一些实施方案,充足的光纤可以是具有纯二氧化硅芯的全二氧化硅光纤。这些光纤通常可以承受输入超过5J/cm2。一些实施方案包括数值孔径(NA)在0.12至0.22范围内的光纤。相关光纤的一个示例是用于UV应用的FiberTech Optica's SUV100/110AN光纤和用于与在1900至2100nm范围内的激光一起使用的低OH版SIR100/140AN或用于传输在2900至3000范围内的辐射的Infrared Fiber Systems,IR Photonics和A.R.T.Photonics GmbH光纤。可以实现单模或多模的实施方案,同时保持光束质量是重要的,但在某些实施方案中不是强制性的。一些实施方案可以包括在顶端区域处的微透镜,以在每个单独的光纤出口处操纵光束。以355nm、10nsec脉冲(约30至60mJ/mm2)进行有效消融所需的功率,接近某些光纤的损伤阈值或高于其损伤阈值,这导致在现有产品中需要延长例如脉冲长度。根据一些实施方案,保持高峰值功率,因此导管可以包括用于通过相对较大的光纤(例如不会一直延伸到顶端部分的末端的100或甚至300微米的光纤)传输激光功率的装置。
一些实施方案的适当激光器的示例是发射约355nm和/或266nm的脉冲的固态紫外(UV)激光器。合适的激光器的示例是固态Nd:YaG激光器,在50Hz下发射355nm、50mJ、10ns脉冲和/或在40Hz下发射266nm、40mJ脉冲。另一示例是准分子激光器。用于非热消融的激光器的其它示例包括具有在1.9至2微米或2.9微米的水吸收附近波长的脉冲激光器。
在使用相当高的重复频率(repetition rate)的情况下,组织中的热效应可能成为问题。这可以通过将消融区域(深度和宽度)最小化、使用短激光脉冲和盐水冲洗来至少部分地解决。另一种选择包括以不是所有光纤同时暴露于激光辐射的方式顺序照明光纤,以能够使受影响的组织热弛豫。
在实施方案中,染料或基质可以用于增强某些波长(例如355nm)下的吸收。例如,在手术前用血卟啉或四环素致敏,以增强经过预处理的动脉粥样硬化斑块的消融,但不增强未致敏的或正常的动脉壁的消融。
一些实施方案的激光器的另一示例是发射中红外(IR)区域(例如在2.8至3微米的范围内,在这个范围内水被非常有效地吸收)中的脉冲辐射的激光器。另外地或可选地,可以使用约2微米的辐射,优选在1910至1940nm范围内(其中有更高的水吸收)发射的铥激光器,优选与Q开关调制(其中消融更有效并减少附带损伤)相结合。对于3微米发射,可以使用Er:YAG,或者另一源,例如直接用二极管激光器泵浦的中红外钬光纤激光器,中红外钬光纤激光器使用氟化物光纤在2840nm处发射[参见Optics Letters,2007年9月1日,第2496至2498页]。
再另一示例是使用Nd:YAG激光器在355nm处的三次谐波,优选为紧凑的全固态二极管泵浦激光器。与308nm辐射相比,355nm辐射通常具有更深的穿透能力,在相关组织和材料中的深度范围为100微米或更大。任选地,使用非常短的脉冲宽度(例如<10ns),以便获得更高的功率密度,并且特别地,能够消融硬组织。根据一些实施方案,每脉冲能量在10至100mJ的范围内,脉冲频率在10至100Hz的范围内。任选地,可以用盐溶液冲洗消融区域,以减少副作用(例如空化),清洁消融区域和导管和/或促进碎片的收集。
使用355nm辐射的一个优点是被认为是相对非诱变的。氯化氙激光器的308nm辐射处于已知具有诱变风险的UVB范围内。[Walter Alexander.Journal of Clinical LaserMedicine&Surgery.1991年8月,9(4):238-241.doi:10.1089/clm.1991.9.238]
一些先前的研究已经表明,由于更长的穿透率和降低的消融效力,三次谐波激光器通常不如308nm激光器更适合于组织消融(参见,例如Grundfest WS等人,AmJ.Surg.1985年8月;150(2):220-6;和Frank Laidback等人,Lasers in Surgery andMedicine 8:60-65(1988))。然而,本发明的实施方案可以成功利用三次谐波Nd:YAG激光器代替复杂且昂贵的准分子激光器。这可以例如使用混合导管来实现,在混合导管中激光器和机械切割器分担组织切除的任务;激光器可以消融和/或削弱至少一些材料,而机械切割器通过最终分离材料来完成工作。根据一些实施方案,切割器可以具有锐度,用于防止未消融组织的切割或将未消融组织的切割最小化。
在一些实施方案中,可以使用发射266nm的辐射的激光器。该波长具有较短的穿透率,此外当前使用的发射308nm辐射的紧凑型准分子激光器可以与当前实施方案一起使用。
根据一些实施方案,系统可以包括使得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,以及控制特定光纤组的功率、重复频率和/或暴露/照明的装置。
本发明的可选实施方案用具有2微米或2.8至3微米辐射的激光器(其中消融是非常有效的)取代UV激光器。
钬激光器通常用于2微米,而铥激光器具有更强的水吸收和更小的吸收长度,这使得它们特别适合于一些实施方案。例如,在实施方案中,使用脉冲光纤铥激光器。可选地,每脉冲的脉冲功率目前在光纤激光器中受到限制,考虑到可以使用的有限脉冲速率,可以使用固态激光器以增加的每脉冲的脉冲功率,以将热积聚和损伤最小化。
2.8至3微米的激光器可以是Er:YAG。Q开关的Er:YAG可用于数百纳秒范围的脉冲,其可以适用于本发明的实施方案。参见例如M.Skorczakowski等人,Laser PhysicsLetters,第7卷,第7期,第498至504页,2010年7月。可以适用于特定实施方案的另一激光器示例是Pantec的DPM-15型固态激光器,其在数百KHz下发射mJ范围内的微秒脉冲。
在实施方案中,使用可以直接二极管泵浦的光纤激光器,例如中红外钬光纤激光器。该激光器可以从基态水平(5|8)泵浦到激发能带(5|),辐射约在1150nm处,弛豫带可以导致在2840nm处的发射(弛豫到带5|7)以及从弛豫到基态的在2100nm处的发射。
因此,该激光器可以直接用最近开发的基于高应变InGaAs量子阱的高功率、高亮度二极管激光器(其在1148nm处产生输出)泵浦。参见Optics Letters,2007年9月1日,第2496至2498页和Stuart D.Jackson Optics Letters,第34卷,第15期,第2327-2329页(2009)。
可以根据所选择的谐振器光学器件选择激光器,谐振器光学器件例如为在2.9-μm跃迁(518至517)发射激光辐射的氟化物光纤激光器,和在2.1-μm跃迁(517至518)发射辐射的二氧化硅光纤激光器。使用在2.9至3微米范围内的激光器的实施方案的优点在于吸收非常高并且导致非常短的吸收长度,仅为15微米量级。因此,弛豫时间较短,因此脉冲频率可以增加至高于100Hz,以加速手术。
在整个以下描述中,装置的不同实施方案的类似元件由相差100的整数倍的元件编号表示。例如,图3的圆柱形顶端部分用数字300表示。对应于图3的圆柱形顶端部分300的图4的圆柱形顶端部分用数字400表示。
现在参考图3A、3B和3C,其示出了根据示例性实施方案的透视图(图3A)和正视图(图3B和3C)中的导管的示例性圆柱形顶端部分300。在一些实施方案中,导管杆(shaft)的其余部分(未示出)可以是(任选地经过涂覆的)生物相容的聚合物管,以将与身体器官的摩擦最小化。
为了便于描述圆柱形顶端部分300,图3A中示出了三个正交轴线。标记为“纵向轴线”的轴线指的是沿着圆柱形顶端部分300的长度从近端301延伸到远端302的中心轴线。标记为“横向轴线”的轴线表示套筒圆柱形顶端部分300的宽度。标记为“竖直轴线”的轴线垂直于横向轴线和纵向轴线两者。
圆柱形顶端部分300可以包括圆柱形壳体303、第一组光纤304a,一组改进的光纤304b和切割器306,第一组光纤304a平行于纵向轴线将光/激光束传输到圆柱形顶端部分300外部,一组改进的光纤304b(“第二组光纤”)使光/激光束相对于纵向轴线横向地反射/偏转到圆柱形顶端部分300外部,切割器306分别位于第一组光纤304a和第二组光纤304b的内部。可选地,在实施方案(未示出)中,切割器可以分别位于第一组光纤304a和第二组光纤304b中的至少一组的外部。本发明的将切割器向内定位的实施方案的实施方案的以下描述旨在,经细节上必要的修改,适用于替代的未示出的实施方案。
切割器306任选为延伸到顶端部分300内部一定深度的环形刀片(未示出)。任选地,切割器306可以联接到合适的马达(未示出),该马达位于顶端部分300中或者进一步在杆中,为切割器306的刀片提供旋转和/或振动动力。任选地,一个或多个柔性构件(未示出)(例如弹簧)可以在其近侧基部处与切割器306相互作用,以允许柔性构件缩回并远离壳体302突出。切割器306的环形刀片可以具有足够薄的边缘,例如约100微米。合适的刀片可以由诸如MDC Doctor Blades、Crescent和UKAM公司定制。刀片可以任选地安装在旋转的可旋转管的端部。这种管可以从诸如Pilling的制造商处获得,Pilling提供一系列激光仪器和刀片制造。刀片可以是金属的或通过将诸如塑料的材料成型而制造,刀片任选地用具有适合体内使用特性的涂层进行涂覆。
示例性的顶端部分可以具有约5mm的外径、约3.4mm的内径(在最内层内,可以是切割器或另外的壁)以及每个具有约0.1至0.2mm直径的光纤。
任选地,第一组光纤304a和第二组光纤304b中的每一组沿着圆柱形顶端部分300的壳体303的内表面定位。第二组光纤304b可以位于第一组光纤304a的外部。任选地,一组改进的光纤304b在导管的周边组装,且光纤在远端处理以实现侧面照明。任选地,一组改进的光纤304b围绕远端缠绕以指向侧面。在这样的实施方案中,可以使用高数值孔径(NA)(例如50微米)的光纤以使不需要的泄漏最小化。
光纤304a和光纤304b中的每一个可以在其近端(未示出)处独立地连接到一个或多个激光源(未示出),激光源的特征在于上面列出的一个或多个参数。光纤304a可以将激光束从光源以平行于圆柱形顶端部分300的纵向轴线的方向传输到身体中的介入部位。光纤304b可以将激光束从光源相对于圆柱形顶端部分300的纵向轴线横向地传输到身体中的介入部位。
参考图3B和3C,为了解决组织的异质性并需要控制坏死以避免损伤血管、体管(duct)和健康组织,可以通过控制到达适当的光纤或光纤组的激光辐射的波长、强度和/或脉冲来传输不同剂量的辐射和辐射类型。
图3B是圆柱形顶端部分300的正视图,示出了嵌入壳体303内的三个改进的光纤304b,表示为304b-1、304b-2和304b-3。每个改进的光纤304b-1、304b-2和304b-3以获得所需冲击需要的波长和剂量如虚线箭头所示传输辐射。光纤304b-1以特定波长和剂量传输辐射,导致相对于圆柱形顶端部分300的纵向轴线横向的区域311的热消融/坏死。
图3C是示出通过光纤304b(本文表示为光纤304b-4、光纤304b-5、光纤304b-6和光纤304b-7)传输不同激光波长用于不同相互作用的类型和/或深度的正视图。对于(例如在区域312中的)大的热冲击,热辐射通过光纤304b-4传输。在非限制性示例中,可以使用诸如980nm的CW激光器,其具有大的穿透性,大的穿透性产生大的热冲击。在另一示例中,可以使用1060CW或Q开关激光器。对于例如在区域313中所示的更受控的冲击,光纤304b-5可以传输来自诸如535nm的激光器的辐射,Q开关可以用于减少热损伤。而且,重复频率和/或功率和/或暴露时间的控制(例如通过控制导管行进)可以影响热损伤的程度。光纤304b-6传输导致如在区域314中所示的非常浅的冲击的辐射。为此,可以控制暴露剂量和/或在一些实施方案中可以使用用于切除的355nm激光器(例如Q开关)。可选的实施方案使用具有高的水吸收的激光器,例如Er:YAG或铥激光器。如图3C所示,血管315在导管的左侧穿过,因此直到导管穿过血管才使用非常靠近血管的光纤304b-7。
在一些实施方案中,导管用于将进入腔、器官(例如胃)、胰腺导管或进入肝脏或胰腺的血管穿孔。在第一操作模式中,使用高功率脉冲激光器与能够穿孔的钝刀片组合,在一些实施方案中通过将激光功率增加至高于某一阈值(例如在355nm波长的10nsec脉冲中,>50mJ/mm2)实现穿孔,当到达目标器官时改变工作模式。在一些实施方案中,将激光器功率降低到30至50mJ范围内的功率密度,直到激光器到达需要切除的病变,然后当添加侧面烧结的激光束时伴随热和/或非热消融。在一些实施方案中,二极管可以代替激光束,在一些实施方案中,添加了用于导热的直接或辅助装置。热元件可以是基于通过激光或电力加热的金属部件。
在一些实施方案中,侧向/横向冲击由PDT引起,在一些实施方案中,导管可以用于递送合成的染料。
在一些实施方案中,在导管顶端的周边处组装小阵列的小电极,以在至少一对电极之间引起局部热冲击。在一些实施方案中,可以用多路复用器将电极联接到RF刺激器,多路复用器用于控制在每个位置在特定时间点激活哪些电极以及需要的待消融区域。
在一些实施方案中,装配至少一个US换能器以实现在线监测。
可选地,在实施方案(未示出)中,顶端部分不包括任何切割器。
现在参考图4A、4B和4C,其分别示出了根据示例性实施方案,分别处于完全组装视图、横截面侧视图和横截面透视图的导管的示例性圆柱形顶端部分400。圆柱形顶端部分400可以类似于图3A-C的顶端部分300,圆柱形顶端部分400有一些改进。类似于图3A-C的圆柱形顶端部分300,圆柱形顶端部分400可以包括第一组光纤404a,一组改进的光纤404b和切割器406,第一组光纤404a平行于纵向轴线将光/激光束传输到圆柱形顶端部分400外部,一组改进的光纤404b(‘第二组光纤’)使光/激光束相对于纵向轴线横向地反射/偏转到圆柱形顶端部分400外部。值得注意的是,第二切割器406a可以相对于顶端部分400周向定位并位于一组改进的光纤304b远端。此外,顶端部分400可以包括收集通道407,收集通道407沿顶端部分400的纵向轴线延伸并延伸到身体外部。任选地,从身体外部应用抽吸元件(未示出),以抽空收集的经过激光器和/或切割器406处理的组织。
任选地,切割器406由第一内壁408界定和/或支撑。任选地,第一组光纤404a由第二内壁409界定和/或支撑。此外,第二组光纤404b由切割器406a近侧的第三壁410界定和/或支撑。
可选地,在实施方案(未示出)中,顶端部分不包括任何切割器。
现在参考图5,其是用于从身体器官切除和消融或凝固不需要的组织的方法的流程图,例如根据例如图3A-C或4A-C的系统中公开的导管。
一种导管,其具有用于传输非热辐射的第一光纤(或一组光纤)、用于传输非热和/或热辐射的第二光纤(或一组光纤)以及任选地切割器,切割器被引入包含不需要的组织的目标部位(步骤520)。任选地,不需要的组织是身体器官内的肿瘤或病变。
将非热激光辐射从激光源通过第一光纤传输到在第一光纤前方需要切除的组织区域,以至少部分地消融或凝固该区域(步骤522)。任选地,第一光纤从其远端边缘沿平行于第一光纤的中心纵向轴线的方向传输激光辐射。
将激光辐射从激光源通过第二光纤传输到围绕第二光纤的不需要的组织区域,以至少部分地消融或凝固该区域或引起热坏死(步骤524)。任选地,改进第二光纤以将激光辐射从远端边缘沿与其中心纵向轴线成角度的方向传输。根据一些实施方案,取决于病变的3D形状和材料,一些(例如,不同的)波长和功率水平可以在不同的方向或相同的方向上用于第二光纤组的每个光纤。
切割穿过不需要的组织以分离至少一部分不需要的组织(步骤526)。任选地,切割由环形切割器完成。
有利地,不需要的组织(例如肿瘤组织)的非热消融允许其以这样的方式切除,即可以采集样本用于活检。因此,该方法可以任选地进一步包括收集分离的组织,例如用于活检(步骤528)。
任选地,将导管通过不需要的组织内的路径或接近不需要的组织的路径行进(步骤530)。
步骤522、524、526、528和530中的每一个可以同时、顺序或间歇进行。另外地或可选地,步骤522、524、526、528和530中的每一个可以以可互换的顺序进行。此外,步骤522、524、526、528和530中的每一个可以重复进行。
现在参考图6A、6B、6C和6D,其示出了用6F(2mm)导管切除猪胰腺中的病变的方法,导管包括基本上类似于图4A-C的圆柱形导管顶端400的圆柱形导管顶端600。在一些实施方案中,可以操纵导管顶端600以进入特定部位。可以将导管通过血管或体管插入,或在腔内手术或以腹腔镜检查和外科手术的一部分通过胃插入。导管可以用于穿过特定器官、血管等的壁,并通过使用激光能量、机械力及其组合到达目标。在一些实施方案中,可以通过增加激光功率来获得穿孔,例如使用>40mJ/mm2的355nm Q开关激光器。在一些实施方案中,其与切除中心组织进行组织学检查结合。
任选地,导管包括用于围绕导管穿过的路径的组织消融的附加装置。这可以减轻与导管穿过肿瘤相关的风险,这种风险可能导致肿瘤细胞扩散,这已知是肝脏活检中的重大风险;和/或导致增加坏死影响的横截面超过导管的横截面积。
在一些实施方案中,通过使用激光消融和/或机械切割引起导管穿过的路径周围的组织的凝固和/或坏死,同时取决于功率和波长(在一些实施方案中可以使用脉冲激光),结合侧面照明以在离导管壁0.1至10mm的距离内(=>当使用直径为2mm的导管时,总冲击长度为2.2至约20mm),引发侧面冲击,而不需要多次的导管插入和/或穿刺来处理大于导管的横截面的肿瘤。
任选地,可以通过在导管顶端处添加直径为2mm的导管、1至12个发射辐射的侧面照明光纤来控制侧面冲击,所述辐射以由波长确定的长度消融和/或凝固组织:例如,使用1550nm激光,长度为1至5mm,使用980/1064nm激光,长度为1至10mm,0.5至2mm=用532和使用UV光的总毫米作为355nm。这些光纤可以是用于切除的消融光纤的一部分,并且收缩覆盖层(covering shrink)可以对这些波长透明,或者光纤可以在没有收缩覆盖层的情况下暴露或者用透明盖作为熔融石英管覆盖。在一些实施方案中,通过角度抛光、化学蚀刻和/或拼接来改进一些圆形照明光纤以用于侧面照明。在一些实施方案中,使用棱镜将发射的光从光纤偏转到侧面。在一些实施方案中,使用衍射/偏转光栅,在一些实施方案中,可以将光栅嵌入光纤输出端。在一些实施方案中,可以将光栅放置在导管远端的近侧。
在一些实施方案中,用顶端处的环形照明获得圆形侧面照明。
根据一些可选的实施方案,该方法可以包括利用混合导管,混合导管包括用于引起目标组织的非热消融的第一组光纤和用于在没有第二组光纤的同时辅助切除组织的切割器,即不将激光辐射传输到不需要的组织周围的区域而引起其热和/或非热消融。光纤和切割器的组合作用确保了对不需要的组织的受控切除,同时避免了对周围组织的潜在有害损伤。根据一些实施方案,该方法可以包括通过将导管重复插入不需要的组织的不同区域而“切片式”地切除不需要的组织(例如肿瘤)。
现在参考图7A和7B,其示出了通过激光切除和热坏死的组合引起的胰腺组织的坏死。在一些实施方案中,圆形照明和具有径向对称性的冲击从临床考虑是足够的,但是在其它实施方案中,需要更局部的控制,例如当需要处理没有径向对称性的肿瘤时和/或当接近敏感结构(例如血管、神经等)时、或当组织不均匀且不同的区域需要不同的能量剂量和/或需要处理可能调节能量剂量响应的影响的已知的散热效应时。由于病变本质上是三维的,并且不同计划中的器官特征不同,在许多相关病例中,对称性可能随着导管穿过肿瘤而改变。
现在参考图8,其示出了通过热消融在猪胰腺中组合切除而没有热损伤和引起的坏死的示例。在照明光纤穿过器官时,其中使用3瓦、980nm的CW激光器,可以看到切除的组织区域831以及由非径向对称照明引起的坏死区域832。在未照明的其它区域中,没有看到坏死833。
在一些实施方案中,医师或机器人可以在导管向前移动时旋转或振动导管,以确保在由特定光纤引起的坏死周边没有“无杀伤”区域。当通过短脉冲引发侧面消融并且其中消融的热特性较小并且因此相互作用限于直接受激光影响的区域并且较少地通过热扩散扩散时,这可能是特别重要的。这种消融效果的示例可以是使用Q开关激光时。
通过控制激光波长、功率和移动速度,可以控制与组织相互作用的特征,从无相互作用到精细凝固到碳化。这在图9中示出,图9是来自鸡胸的切口,其中使用2瓦CW 1550nm激光器,示出了碳化区域934以及无相互作用区域935到凝固区域936。在其它实施方案中,也未示出可以使用脉冲激光的非热消融和/或可以使用热消融和非热消融的组合。
虽然上面已经讨论了许多示例性方面和实施方案,但是本领域技术人员将认识到其某些修改、置换、添加和子组合。因此,以下所附权利要求和此后引入的权利要求旨在被解释为包括在其真实精神和范围内的所有这些修改、置换、添加和子组合。
在本申请的说明书和权利要求书中,词语“包括”、“包含”和“具有”中的每一个及其形式不必限于与词语相关联的列表中的成员。
应当理解的是,为了清楚起见,在单独的实施方案的上下文中描述的本发明的某些特征也可以在单个实施方案中组合提供。相反,为了简洁起见,在单个实施方案的上下文中描述的本发明的各种特征也可以单独提供或以任何合适的子组合提供,或者在本发明的任何其它描述的实施方案中适当地提供。在各种实施方案的上下文中描述的某些特征不被认为是那些实施方案的必要特征,除非该实施方案在没有这些元素的情况下不起作用。本文参考根据本发明实施方案的方法、装置(系统)和计算机程序产品的流程图说明和/或框图来描述本发明的各个方面。将理解的是,流程图说明和/或框图的每个框以及流程图说明和/或框图中的框的组合可以由计算机可读程序指令实现。
附图中的流程图和框图示出了根据本发明的各种实施方案的系统、方法和计算机程序产品的可能实现的体系结构、功能和操作。在这方面,流程图或框图中的每个框可以表示模块、段或指令的一部分,其包括用于实现指定的逻辑功能的一个或多个可执行指令。在一些替代实施方式中,框中提到的功能可以以与图中所示的顺序不同的顺序发生。例如,连续示出的两个框实际上可以基本上同时执行,或者这些框有时可以以相反的顺序执行,这取决于所涉及的功能。还应注意的是,框图和/或流程图说明的每个框以及框图和/或流程图说明中的框的组合可以由执行特定功能或行为或执行专用硬件和计算机指令的组合的专用基于硬件的系统来实现。
尽管已经结合本发明的具体实施方案描述了本发明,但显然许多替代、修改和变化对于本领域技术人员来说是明显的。因此,旨在涵盖落入所附权利要求的精神和广泛范围内的所有这些替代、修改和变化。本说明书中提及的所有出版物、专利和专利申请均通过引用整体并入本说明书中,其程度如同每个单独的出版物、专利或专利申请被具体和单独地指出以通过引用并入本文。另外,本申请中任何参考文献的引用或标识不应被解释为承认这样的参考文献可用作本发明的现有技术。
Claims (32)
1.一种用于从受试者的身体切除不需要的组织的导管,所述导管包括呈圆柱或圆柱扇区形状的顶端部分并具有中心纵向轴线,所述顶端部分包括:
中心纵向腔;
第一组光纤,用于在平行于所述中心纵向轴线的方向上将激光辐射传输到所述顶端部分的远端末端外部;
第二组光纤,用于相对于所述中心纵向轴线横向地传输激光辐射;
其中所述第一组光纤和所述第二组光纤可选择性地操作以切除和/或消融所述不需要的组织。
2.根据权利要求1所述的导管,其中所述第一组光纤和所述第二组光纤根据所述不需要的组织的图像独立地且可选择性地操作。
3.根据权利要求1所述的导管,其中所述第一组光纤用于切除在所述第一组光纤前方的组织以到达需要被移除的组织。
4.根据权利要求1所述的导管,其中所述第二组光纤中的每根光纤或每个光纤子集根据所述不需要的组织的图像是独立地且分别地可控的,以选择性地消融所述不需要的组织或其部分。
5.根据权利要求1所述的导管,其中所述导管进一步用于促进以允许其实验室测试的形式提取切除的不需要的组织或其部分。
6.根据权利要求1所述的导管,其中所述第一组光纤沿着并平行于所述中心纵向轴线定位,并且延伸到所述顶端部分的远端末端。
7.根据权利要求1所述的导管,其中所述第二组光纤沿着并平行于所述中心纵向轴线定位,并且近侧延伸到所述顶端部分的远端末端。
8.根据权利要求1所述的导管,其中所述导管还包括切割器,所述切割器包括用于切割所述不需要的组织的一个或多个刀片,其中所述切割器定位在从所述第一组光纤和所述第二组光纤传输的所述激光辐射的光路之外。
9.根据权利要求8所述的导管,其中所述切割器由所述顶端部分的壁的远端边缘形成或固定到所述顶端部分的所述壁的所述远端边缘。
10.根据权利要求9所述的导管,其中所述壁具有尖锐的远端边缘。
11.根据权利要求1所述的导管,其中所述激光辐射是脉冲辐射。
12.根据权利要求1所述的导管,其中所述第一组光纤可操作地联接到第一激光器,所述第二组光纤可操作地联接到第二激光器和/或激光二极管。
13.根据权利要求1所述的导管,其中所述第二组光纤可操作地联接到多路复用激光器,所述多路复用激光器用于以不同的波长、强度和/或脉冲发射激光辐射。
14.一种用于从受试者的身体切除不需要的组织的系统,所述系统包括:
导管,所述导管包括呈圆柱扇区形状的顶端部分并具有中心纵向轴线,所述顶端部分包括:
中心纵向腔;
第一组光纤,用于在平行于所述中心纵向轴线的方向上将激光辐射传输到所述顶端部分的远端末端外部;和
第二组光纤,用于相对于所述中心纵向轴线横向地传输激光辐射;和
处理器,用于基于在切除所述不需要的组织之前和/或期间获得的所述不需要的组织的位置和/或3D图像,选择性地控制至少由所述第二组光纤传输的激光辐射的至少一个参数。
15.根据权利要求14所述的系统,其中所述至少一个参数包括波长、功率、强度、脉冲频率或它们的任何组合。
16.根据权利要求14所述的系统,其中所述处理器还用于选择性地激活所述第二组光纤中的每根光纤或每个光纤子集。
17.根据权利要求16所述的系统,其中所述处理器还用于确定所述导管的行进速度/速率。
18.根据权利要求14所述的系统,其中所述系统还包括提取机构,用于促进以允许所述不需要的组织的实验室测试的形式提取所述切除的不需要的组织或其部分。
19.根据权利要求14所述的系统,其中所述系统还包括至少可操作地联接到所述第二组光纤的多路复用激光器。
20.根据权利要求14所述的系统,其中所述系统还包括可操作地联接到所述第一组光纤的第一激光器和可操作地联接到所述第二组光纤的第二激光器。
21.根据权利要求14所述的系统,其中所述系统还包括可操作地联接到所述第一组光纤的第一激光器和可操作地联接到所述第二组光纤中的光纤的至少两个激光二极管。
22.根据权利要求14所述的系统,其中所述系统还包括切割器,所述切割器包括用于切割组织的一个或多个刀片,其中所述切割器定位在由所述第一组光纤和所述第二组光纤传输的所述激光辐射的光路之外。
23.根据权利要求14所述的系统,其中所述系统还包括切割器,所述切割器包括用于切割组织的一个或多个刀片,其中所述切割器由对从所述第二组光纤发射的所述辐射透明的材料制成。
24.一种用于从受试者的身体切除不需要的组织的方法,所述方法包括:
利用具有纵向轴线的导管和第一组光纤以及第二组光纤,将激光辐射通过所述第一组光纤传输到所述不需要的组织的第一区域,从而引起其非热消融和/或切除,其中所述辐射在基本平行于所述纵向轴线的第一方向上传输;以及
将激光辐射通过所述第二组光纤传输到所述不需要的组织的第二区域,从而引起其热或非热消融,其中来自所述第二组光纤的所述辐射在第二方向上传输,所述第二方向不平行于所述第一方向;并且其中由所述第二光纤传输的所述激光辐射的至少一个参数是可控的。
25.根据权利要求24所述的方法,其中所述方法还包括利用定位在所述导管上的切割器切割穿过所述不需要的组织,从而切除至少一部分所述不需要的组织。
26.根据权利要求24所述的方法,其中传输所述第一激光辐射和所述切割同时进行。
27.根据权利要求24所述的方法,其中传输激光辐射和切割间歇进行。
28.根据权利要求24所述的方法,其中所述方法还包括获得所述不需要的组织的图像。
29.根据权利要求24所述的方法,其中所述方法还包括基于对所述不需要的组织的所述图像的解释,选择性地激活所述第二组光纤中的每根光纤或每个光纤子集。
30.根据权利要求24所述的方法,其中,所述至少一个参数包括波长、功率、强度、脉冲频率或它们的任何组合。
31.根据权利要求24所述的方法,其中所述方法还包括以允许所述不需要的组织的实验室测试的形式提取所述切除的不需要的组织。
32.根据权利要求24所述的方法,其中所述方法还包括使所述导管通过所述不需要的组织内的路径或接近所述不需要的组织的路径行进的步骤。
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US20190125447A1 (en) | 2019-05-02 |
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