CN102271602A - 用于治疗前列腺组织的系统和方法 - Google Patents
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Abstract
本发明提供了一种前列腺治疗系统,该前列腺治疗系统可包括下列多个特征中的任何一个。该前列腺系统的一个特征是它能够经尿道接近前列腺叶。该前列腺治疗系统的另一特征是它能够向前列腺输送可冷凝蒸气以消融前列腺组织。该前列腺治疗系统的另一特征是它能够从前列腺吸取组织。该前列腺治疗系统又一特征是它能够在蒸气输送和组织吸取期间旋转。本发明还涵盖了与该前列腺治疗系统的使用相关的方法。
Description
相关申请的交叉参考
根据美国35U.S.C.119,本申请要求于2008年11月6日提交的、名称为“Systems and Methods for Treatment of Prostatic Tissue(用于治疗前列腺组织的系统)”的美国临时专利申请No.61/112,099的权益。该申请整体结合在此以作参考。
引用结合
本说明书中提到的所有公报和专利申请都通过引用结合于此,引用程度与每个单独公报或专利申请明确且单独地通过引用结合相同。
技术领域
本发明涉及一种用于微创治疗前列腺组织的设备和相关方法。
背景技术
已经开发或提出了若干用于治疗前列腺组织的系统和方法,以减轻BPH症状或治疗前列腺组织。例如,已有基于RF消融、微波消融、高强度聚焦超声波(HIFU)、冷冻消融、辐射、外科手术和近距治疗的组织消融方法。已经开发了利用或不利用机器人辅助的外科手术方法来移除病变前列腺组织。
这里公开的设备、技术和方法通常适合于治疗前列腺组织,更具体地说,集中于治疗BPH(良性前列腺增生)和前列腺癌。BPH是约50多岁的男人所经历的涉及尿路梗阻的普遍问题。前列腺增生或前列腺腺体的增大导致尿路压缩和受阻,这导致诸如需要频繁排尿、排尿量降低、遗尿和不舒适之类的症状。
利用电磁能量消融前列腺组织是公知的,并且具有可进行微创治疗的优点。例如,电外科消融或前列腺组织中的高频电流导致细胞破裂和细胞死亡。通过身体伤愈反应产生的组织再吸收随后能够致使可能导致尿路梗阻的组织体积减小。高频电流或激光消融的一个缺陷是潜在的组织碳化,这会导致消融之后炎症反应增加和愈合时间过长。
发明内容
本发明提供了一种治疗(处理)前列腺病变的方法,该方法包括:经尿道将消融探针导入前列腺内,该消融探针具有纵向轴线;沿着所述纵向轴线平移所述消融探针,同时通过所述消融探针向前列腺内注射可冷凝蒸气;以及通过所述消融探针吸取(抽吸)附近的前列腺组织。
在一些实施例中,该方法还包括将导入器插入尿道内并使该消融探针前进穿过该导入器。导入步骤可包括使消融探针前进到前列腺叶的顶点内。
在一个实施方式中,该方法还包括移除前列腺组织的芯部。该方法还可包括旋转所述消融探针。在一些实施方式中,该方法还可包括通过所述消融探针向前列腺内注射高压液体。
在一些实施方式中,注射可冷凝蒸气包括将在100W和1000W之间(的能量)输送至前列腺。在另一实施方式中,注射可冷凝蒸气包括将在100cal/g和600cal/g之间(的能量)输送至前列腺。在另一实施方式中,该方法包括从前列腺移除在1g和100g之间的前列腺组织。
本发明提供了一种前列腺治疗系统,该前列腺治疗系统包括可冷凝蒸气源以及消融探针,该消融探针适合于经尿道插入成年男性受体的前列腺叶内,所述消融探针具有蒸气输送端口和吸取端口,该蒸气输送端口与所述蒸气源连通并适合于将可冷凝蒸气输送至前列腺叶,该吸取端口适合于将附近的前列腺组织吸取到所述消融探针内。
在一些实施方式中,消融探针还构造成在前列腺内旋转。动力旋转马达(带动力的旋转马达,电动旋转马达)可以适合于使消融探针以在5rpm和10,000rpm之间(的速度)旋转。
该前列腺治疗系统还可以包括高压液体源,该高压液体源与所述消融探针中的液体喷射端口连通。
附图说明
图1是蒸气能量输送系统,更具体地说是仪器的手柄部的剖视图,该手柄部具有用于向流体流施加蒸发能量的感应加热组件和用于维持高能蒸气的循环流动的环流系统,该高能蒸气可根据需要释放以便流过延伸构件而与组织相互作用。
图2是图1的感应加热组件的示意图。
图3是患者前列腺和将组织选择性提取装置引入患者尿道的第一步骤的示意图,其中示出作为“取芯”或提取的目标的组织体。
图4是图3的患者前列腺以及通过邻近尿道的前列腺将工作端部或组织选择性提取装置引入到前列腺的近端病灶中的随后步骤的示意图。
图5是图4的工作端部的剖面图,示意性示出如何选择性地提取组织。
图6是另一仪器工作端部的示意图。
图7是另一仪器工作端部的示意图。
图8是另一仪器工作端部的示意图。
图9是另一仪器工作端部的示意图。
图10是另一仪器工作端部的示意图。
具体实施方式
本发明提供了一种蒸气能量发生系统,该蒸气能量发生系统可以构造成用于引入患者的尿道或前列腺中,或者可以构造经直肠或利用内窥镜进入前列腺组织。该系统构造成将加热的蒸气例如水蒸气如在下列共同待审的美国专利申请中那样输送到组织:于2003年10月7日提交的名称为“Medical Instruments and Techniques for Thermally-mediated Therapies(用于热介入疗法的医疗仪器和技术)”美国专利申请No.10/681,625、于2005年6月22日提交的名称为“Medical Instruments and Techniques forTreating Pulmonary Disorders(用于治疗肺部疾病的医疗仪器和技术)”的美国专利申请No.11/158,930、于2005年10月5日提交的名称为“MedicalInstrument and Method of Use(医疗仪器和使用方法)”的美国专利申请No.11/244,329以及于2006年1月10日提交的名称为“Medical Instrumentand Method of Use(医疗仪器和使用方法)”的美国专利申请No.11/329,381。
用于各种治疗程序的可压缩高能蒸气的产生和输送在共同待审的美国专利申请No.60/929,632、No.61/066,396、No.61/068,049中的具有“远程”蒸气产生系统或源或者具有位于手柄或工作端部中的蒸气发生器或二者的组合的系统中进一步公开,如在临时专利申请No.61/068,130、No.61/123,384、No.61/123,412、No.61/126,651、No.61/126,612、No.61/126,636和No.61/126,620中所述。
图1示出具有手柄802的蒸气能量发生系统800,该手柄802包括与申请61/123,416、61/123,417和61/126,647中描述的类似的感应加热系统。在图1中,手柄802通过耐热配件806联接至以受控流量和压力输送液体的液体或流体源810。液体流经过联接至电源和控制器820的蒸气发生感应加热器805。该系统和手柄构造成用于循环液体/蒸气流以向工作端部或退出通道822提供蒸气,由此将蒸气输送至组织部位。该系统具有可以与收集储存器830和/或负压源835连通的、以附图标记824表示的流入通道和以附图标记826表示的流出通道。在流出通道826中设置有例如通过脚踏开关操作的阀836,以将蒸气重新引导到退出通道822和延伸构件840。
如图1所示的蒸气能量发生系统800可以用于任何外科手术/医疗应用,其中延伸构件840包括细长消融探针、针、柔性导管或其他类似的细长输送装置。该系统可以用于输送能量的导管,以用于血管内应用、用于治疗呼吸道紊乱、用于子宫内膜消融治疗或用于针消融治疗。在图1的实施例中,示出了可选的第二加热器845,其具有同心的绝缘器846。该第二加热器能够向开始流过退出通道822的蒸气增加更多的蒸发能量。第二加热器可以是感应加热器或电阻加热器,其利用多微孔材料来提供大表面面积,以便向蒸气施加能量从而移除任何水滴。该系统能够提供至少为90%的水蒸气的蒸气。该第二加热器通过电导线(未示出)操作性地联接至电源和控制器820。
图2示出蒸气发生感应加热器805,它在一个实施例中包括其中具有孔852的陶瓷柱体850。该陶瓷柱体850例如可以大约长度为1.0英寸至1.5英寸,直径为0.25英寸,孔852为0.10英寸。孔852可填充有多个小直径的海波管(hypotube)855,所述海波管是磁响应的,例如为316不锈钢。在一个实施例中,海波管855是0.016薄壁管。可以围绕陶瓷柱体850设置轴向长度大约1.0英寸的一至十层的绕组860,以便利用来自电源的极高频电流在海波管855中感应出热。在一个实施例中,绕组860可以是具有特氟龙涂层的26Ga的铜线。已经发现,利用适当流量的水输送至少50W、100W、300W、400W或600W能够产生非常高质量的蒸气,例如90%和更好的蒸气。
在图2中,可以看到,感应加热的海波管855’还可被螺旋切割以便为将定位在导管或探针工作端部中的感应加热器提供灵活性(柔性)。例如,这种柔性可加热元件可以装载在柔性耐高温聚合绝缘构件的孔中,从而提供被构造成用于血管内导航的柔性导管。围绕感应加热器的外部的绝缘层没有示出。通常,蒸气发生感应加热器805能构造成提供在蒸气质量、来自工作端部的出口蒸气压力、出口蒸气温度方面具有精确参数的高质量蒸气介质,以及在治疗间隔上将所述参数维持在严格范围内。所有这些参数都能够以高精度水平进行控制以获得受控剂量,无论具体治疗在治疗间隔上要求极低压力(例如1-5psi)或极高压力(例如200psi或更大),并且不管治疗间隔是在1-10秒的范围内还是在2-5分钟的范围内。
现在转到图3-4,包括具有成像系统104的细长导入器102的系统被导入患者前列腺106内的尿道105内,并且被引导至预定部位,在该部位该仪器的远端和成像系统104能够识别解剖学标记。在一个实施方式中,导入器102具有轴向通道110,该轴向通道110承载可伸出的消融探针115,如图4所示。在图3中,可以看到,在前列腺的相对叶中的组织区域或芯部120A和120B被确定为与提取的组织体的边缘热合同时地移除的目标。消融探针115适合于经尿道插入男性受体的前列腺叶内,以将可冷凝蒸气输送至前列腺叶并吸取消融探针附近的前列腺组织。
参照图4,消融探针115具有工作端部125,该工作端部125构造成向前列腺组织施加机械和热能以消融并按体积地移除尿道附近的组织。该工作端部的直径例如可以从约2mm到6mm。该工作端部125可以以图5所示的方法在前列腺内轴向地前后平移以消融和移除组织。另外,回到图4,消融探针操作性地联接至蒸气源100、吸取装置180和控制器185。蒸气源100可以是可冷凝蒸气源,例如以上在图1中描述的蒸气能量发生系统。吸取装置180可以是负压或真空源以向消融探针提供吸力,而控制器185可以用于控制蒸气向患者的输送以及从患者的组织的吸取。该控制器可以包括计算机或CPU以及供外科医生使用以在外科手术过程中控制蒸气输送和吸力的控制件(例如,操纵杆,位于消融探针的近端上的按钮或杠杆,鼠标/键盘等)。
仪器工作端部125在图5中以剖视图示出,从中可以看出,蒸气系统或源100(例如图1中描述的源)流体联接至至少一个蒸气流入通道160,该蒸气流入通道160延伸至装置远端的凹部65中的至少一个蒸气输送端口164。每个蒸气输送端口的轴线相对于轴线170都可以非轴向地指向,仪器和轴线内向指向装置轴线170。蒸气喷射轴线相对于轴线170可以具有在大约10°和90°之间的角172。
仍然参照图5,消融探针115具有吸取端口175和控制器(未示出),该吸取端口175与吸取装置或负压源180流体连通,该控制器用于将组织吸入工作端部凹部165内并抽取蒸气和组织碎屑。该吸取端口适合于吸取消融探针附近的前列腺组织。在使用中,能够理解,如图5所示从端口164高压注射蒸气会导致热损坏,从而使蛋白质和组织成分削弱和变性,而同时其中的蒸气和水滴会施加足够的机械力而分解并按体积移除蒸气组织界面处的组织。在一个实施方式中,蒸气的量或喷射蒸气和喷射水滴的组合会切断热削弱的组织。
参照图3至图5,能够理解如何在起动蒸气流的同时轴向平移工作端部125以及负压源将前列腺组织内的组织块掏空(图3)。另外,参照图4,工作端部125能够在蒸气输送和吸取期间旋转,以用于附加地掏取。工作端部的旋转可以是手动的(例如,通过外科医生进行仪器的物理旋转),或另选地可以将旋转机构186(例如动力旋转马达)联接至工作端部125,以在消融和抽取期间自动地旋转装置的远端。该旋转机构可以构造成使消融探针例如以在5rpm和10,000rpm之间的速度旋转。在美国专利申请No.12/389,808和No.61/123,416中描述了在组织中旋转消融探针的方法的更多细节,所述申请通过引用结合在本文中。
蒸气流和相变能量释放同时密封或凝结组织边缘以防止出血。治疗之后,与在原来位置消融类似组织的其他方法相比,身体伤口愈合响应使前列腺更快地恢复到愈合状态,这是由于再次被吸收的组织负担大大降低。为了使工作端部125前进通过尿道壁,可以使用顶端尖锐的套筒(未示出)来刺穿管腔壁。
图6示出了与图5类似的另一个实施方式,其中与组织接收和消融结构具有类似功能的工作端部125’相对于装置的轴线成一定角度地定向。成角度的工作表面因而适合于稍微朝向装置的侧面消融、分解和抽取组织,并且使用方法包括与轴向平移一起低速或高速旋转。
图7示出与图5-6类似的另一实施方式,其中与组织接收和消融结构具有类似功能的工作端部125”在延伸构件的一侧与装置的轴线基本平行地定向。侧抽取端口因而适合于消融、分解和抽取组织,并且使用方法包括与轴向平移一起低速或高速旋转。
图8示出与图5-7类似的另一实施方式,其中工作端部200也适合于基本平行于装置的轴线在延伸构件的一侧消融、分解和抽取组织。在该实施方式中,系统包括与工作端部中的液体喷射端口225连通的极高压液流喷射源220,其中所喷射的液体能分解、消除和切断组织。该系统还包括如上所述的蒸气源,以用于从至少一个端口喷射高温蒸气以密封所分解的组织的边缘。
图9示出类似于工作端部200的另一实施方式,与图8的实施例类似,该工作端部200适合于在延伸构件的一侧消融、分解和抽取组织。图9的实施方式具有高压液流喷射源220,该喷射源具有从装置的轴线向外指向的液体喷射端口225。蒸气输送端口类似地定向。在使用方法中,如以上图4中所述,工作端部能够以高速旋转,以确保流体射流仅仅切割或分解受控的、有限深度的组织。
图10示出工作端部250的另一个实施方式,与图8类似,该工作端部250适合于消融、分解和抽取组织。图10的实施方式具有高压液流喷射源220,该高压液流喷射源具有在高速旋转时通向吸取端口的液体喷射端口。蒸气输送端口在以从约5rpm到10,000rpm的任意高速旋转时滞后于吸取端口暴露。在一个方法中,流体射流以1到100脉冲/秒的速率脉动。在另一实施方式中,流体射流通过水和蒸气的间断脉冲以高重复速率脉动,且所喷射水的测定用量能够分解组织,并且蒸气的测定用量配置成能够削弱组织和热密封组织。
在另一实施方式中,工作端部可以承载第一和第二出口,用于以倾斜交叉的轴线喷射以对组织进行受控深度的分解。
通常,用于治疗前列腺病变的方法包括基本上对患者尿道没有损伤地按体积量移除至少一个前列腺叶中的前列腺组织。该按体积量移除组织的方法可以通过从装置工作端部喷射加热流体诸如可冷凝蒸气并且吸取分解的组织来进行。在本发明的一个方面中,流体介质的喷射施加了足够的热能以实质上使组织改变,其中,所述改变包括削弱共价键、蛋白质变性和破坏胶原质结构中的至少一种。另外,流体介质的喷射施加了足够的机械能量以移除组织,其中移除包括分解、切割、切除和消融组织中的至少一种。在本发明的另一方面中,流体介质的喷射施加了足够的热能以密封或凝结所移除的组织的边缘。另外,按体积量移除组织的方法能够与成像例如超声成像同时地进行。
通常,用于治疗前列腺病变的方法包括在保持尿道开放的同时在至少一个前列腺叶中从尿道沿径向向外按体积量移除前列腺组织。该方法通过从装置工作端部喷射加热蒸气介质以及吸取分解组织来按体积量移除组织。该方法从喷射的可冷凝蒸气向前列腺施加等于至少100W、250W、500W和1000W的能量。在另一实施方式中,可冷凝蒸气向前列腺内的喷射向前列腺输送在100cal/g和600cal/g之间(的能量)。
通常,治疗前列腺病变的方法包括按体积量移除等于至少10g、至少20g、至少30g、至少40g和至少50g的前列腺组织。在另一实施方式中,可以移除在1g和100g之间的前列腺组织。该方法包括热凝结所移除的组织周围的边缘。本发明的方法包括在维持尿道开放的同时切割并提取至少一个区域的前列腺组织。
在一个实施方式中,治疗前列腺病变的方法包括经尿道将消融探针引入前列腺内,沿着消融探针的纵向轴线平移该消融探针,同时通过消融探针向前列腺内注射可冷凝蒸气,并吸取消融探针附近的组织。利用该方法可以移除前列腺组织的芯部。在一些实施方式中,消融探针可以在蒸气注射和组织吸取过程中旋转。在其他实施方式中,可以通过消融探针将高压液体注射到前列腺内。
为了获得接近前列腺的途径,可以将导入器导入尿道内,并且消融探针可以通过导入器前进。消融探针因而能够前进到前列腺叶的顶点。
一种系统包括:具有工作端部的细长组织提取构件,该组织提取构件构造成经间质穿入患者前列腺中;与远端中的蒸气输送端口流体连通的蒸气源;与一通道联接的负压源,该通道与工作端部近端蒸气输送出口的组织抽取端口流体连通。所述端口可以相对于组织抽取构件的轴线较远地定向,或相对于组织抽取构件的轴线成一定角度地定向,或与组织抽取构件的轴线基本平行地在组织抽取构件的一侧定向。
在一个实施方式中,前列腺治疗系统包括:可冷凝蒸气源;适合于经尿道插入成年男性受体的前列腺叶内的消融探针,该消融探针具有蒸气输送端口和吸取端口,该蒸气输送端口与蒸气源连通并适于将可冷凝蒸气输送到前列腺叶,该吸取端口适合于吸取消融探针附近的前列腺组织。
另一系统包括:具有工作端部的组织抽取构件,该组织抽取构件构造成经间质穿入患者前列腺内;与远端中的至少一个蒸气输送端口流体连通的蒸气源,用于向组织施加热能;以及高压液体喷射源,其与远端中的出口连通以用于分解组织。该系统还包括负压源,该负压源联接至一与工作端部中的组织抽取端口流体连通的通道。
通常,本发明的方法包括输送可冷凝蒸气,该可冷凝蒸气经受相变以提供至少250cal/g、300cal/g、350cal/g、400cal/g和450cal/g的蒸气能量。
在另一实施方式中,利用蒸气进行治疗可以在任何适当类型的成像作用完成。在一个方法中,可以通过超声或X射线成像观察步骤的进行。在一个方法中,本发明的导入器导入和能量输送方法可以通过利用经直肠超声系统的超声系统进行成像。
在本发明的另一方面中,该系统可以同时用于将流体输送前列腺内的目标位置以用于治疗目的,例如用于整体或局部药物输送、化疗或注射可通过蒸气或热起动的其他制剂。
对于关于本发明的附加细节,材料和制造技术可以在本领域普通技术人员的水平内一样地采用。在普通或局部采用的附加动作方面这同样适合于本发明的方法。而且,可以想象,所描述的本发明变型的任何可行特征可以单独地阐述和要求保护,或者与本文描述的特征中的一个或更多个相结合地来阐述和要求保护。同样,对于单数项目的引用包括存在多个同一项目的可能性。更详细地说,如这里及权利要求书中所使用的,单数形式“一”、“所述”和“该”包括复数引用,除非另有明确地说明。还应进一步注意到,所述权利要求可能被撰写成排出任何可选元件。这样,这种陈述旨在用作这种排斥性术语例如“仅仅”、“只”等与权利要求元素有关的使用的引用基础,或用作消极限定的使用的引用基础。除非本文另有明确说明,否则这里使用的所有技术和科学术语具有与本发明所属技术中一个普通技术人员通常理解的含义。本发明的范围不受题述说明书的限制,而是仅仅所采用的权利要求术语的平常含义来限定。
Claims (17)
1.一种治疗前列腺病变的方法,该方法包括:
经尿道将消融探针导入前列腺内,该消融探针具有纵向轴线;
沿着所述纵向轴线平移所述消融探针,同时通过所述消融探针向前列腺内注射可冷凝蒸气;以及
通过所述消融探针吸取附近的前列腺组织。
2.根据权利要求1所述的方法,其特征在于,该方法还包括将导入器插入尿道内,以及使所述消融探针前进穿过所述导入器。
3.根据权利要求1所述的方法,其特征在于,导入步骤包括使消融探针前进到前列腺叶的顶点内。
4.根据权利要求1所述的方法,其特征在于,该方法还包括移除前列腺组织的芯部。
5.根据权利要求1所述的方法,其特征在于,该方法还包括旋转所述消融探针。
6.根据权利要求1所述的方法,其特征在于,该方法还包括通过所述消融探针向前列腺内注射高压液体。
7.根据权利要求1所述的方法,其特征在于,注射可冷凝蒸气包括向前列腺输送100W至1000W。
8.根据权利要求1所述的方法,其特征在于,注射可冷凝蒸气包括向前列腺输送250cal/g至450cal/g。
9.根据权利要求1所述的方法,其特征在于,该方法还包括从前列腺移除10g至50g的前列腺组织。
10.根据权利要求1所述的方法,其特征在于,该方法还包括在维持尿道开放的同时提取至少一个区域的前列腺组织。
11.根据权利要求1所述的方法,其特征在于,注射可冷凝蒸气包括向前列腺输送100cal/g至600cal/g。
12.根据权利要求1所述的方法,其特征在于,该方法还包括从前列腺移除1g至100g的前列腺组织。
13.一种前列腺治疗系统,该前列腺治疗系统包括:
可冷凝蒸气源;以及
消融探针,该消融探针适合于经尿道插入成年男性受体的前列腺叶内,
所述消融探针具有蒸气输送端口以及吸取端口,该蒸气输送端口与蒸气源连通并适合于将可冷凝蒸气输送至前列腺叶,该吸取端口适合于将附近的前列腺组织吸取到所述消融探针内。
14.根据权利要求13所述的系统,其特征在于,所述消融探针还构造成在前列腺内旋转。
15.根据权利要求14所述的系统,其特征在于,该系统还包括用于使所述消融探针在前列腺内旋转的动力旋转马达。
16.根据权利要求15所述的系统,其特征在于,所述动力旋转马达构造成使所述探针以5rpm至10,000rpm旋转。
17.根据权利要求13所述的系统,其特征在于,该系统还包括高压液体源,该高压液体源与所述消融探针中的液体喷射端口连通。
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BRPI0921122A2 (pt) | 2016-02-16 |
EP2352452A4 (en) | 2012-07-18 |
EP2352452A1 (en) | 2011-08-10 |
US8585692B2 (en) | 2013-11-19 |
JP2012508068A (ja) | 2012-04-05 |
US20130226164A1 (en) | 2013-08-29 |
WO2010054220A1 (en) | 2010-05-14 |
US20100145254A1 (en) | 2010-06-10 |
US8419723B2 (en) | 2013-04-16 |
AU2009313397A1 (en) | 2010-05-14 |
AU2009313397A2 (en) | 2011-06-16 |
CA2742560A1 (en) | 2010-05-14 |
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