CN1128943A - 良性前列腺肥大或增生(bph)的去除方法和设备 - Google Patents
良性前列腺肥大或增生(bph)的去除方法和设备 Download PDFInfo
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- CN1128943A CN1128943A CN94192685A CN94192685A CN1128943A CN 1128943 A CN1128943 A CN 1128943A CN 94192685 A CN94192685 A CN 94192685A CN 94192685 A CN94192685 A CN 94192685A CN 1128943 A CN1128943 A CN 1128943A
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Abstract
本发明公开了用于传输可控的热量实现治疗前列腺肥大或增生(BPH)的去除方法和设备(14)。按照本发明的方法和设备(14),能量直接传输到以提供组织去除而不会伤及周围组织的方式治疗的组织块(6)。当多个周围区域,包括尿道(2)或周围组织或相邻的器官之一超过预定的安全温度极限时,自动切断电源。在整个所确定的时间内施加常值的射频能量提供了一种安全的方法,该方法避免了电外科和其它的侵袭性的操作,同时提供了一种恢复时间短的快速去除BPH的方法,这种方法可以在门诊室中完成,无需住院或外科手术。
Description
相关的未决申请
本申请是共同未决的1992年8月12日申请的申请号为07/929,638和1993年2月2日申请的申请号为08/012,370的部分继续申请,上述申请的全部内容在此作为参考文献引入。
技术领域
本发明涉及专门用于传输可控热量为治疗良性前列腺肥大或增生(BPH)实现去除的方法和设备。所述的方法和装置通过如上述共同未决申请所公开的装置把可控的热量传输到被穿透的组织内。
背景技术
由细胞组织的治疗通常要求目标组织与医疗器械直接接触,上述通常通过外科手术实际上暴露被操作的目标和插入的组织。治疗探头的准确定位一般是困难的,因为存在着目标组织在体内的定位,或易于操作目标组织周围的重要人体器官、神经或其它部分。
良性前列腺肥大或增生(BPH),例如,是50岁以上的男性最经常遇到的医学上的问题之一。医学上很早就已认识到尿路梗阻是由于前列腺增生引起的。前列腺的肥大通常导致尿道受压,引起尿路梗阻,继而出现的症状包括尿频、尿量减少,夜尿(症),疼痛,不适和尿液滴落等。业已表明BPH与年龄有关,50岁以上的男性中有超过50%的人患有此病,而在80岁以上的男性中发病率增加到75%以上。尿路梗阻的症状在65岁到70岁之间最易于发生,在该年龄段大约有65%的男性都患有前列腺增大。
目前还不能证明有有效的治疗BPH的非外科手术方法。此外,即使用外科手术也不能完全满足要求。目前出现这种疾病梗阻症状的病人有几种选择方案;继续以对症治疗(亦即保守处置),主张在早期药疗,或者主张外科干预。在美国每年大约有30,000多人进行外科手术切除前列腺组织,这些代表不足百分之五的呈现明显临床症状的男性。
患BPH的这些人通常都是年龄较大的男性,其中有许多还带有增加外科手术危险的其它健康问题。用于切除前列腺组织的外科手术与许多危险有关,包括与发病率有关的麻醉,出血,凝血病,肺栓子和电解质不平衡等。现行的这些手术也可能导致心脏并发症,膀胱穿孔,尿失禁,感染,尿道和膀胱颈狭窄,前列腺碎片潴留,逆行射精和不育症。对于梗阻的尿路病,由于现行的治疗选择方案使之继续发病,许多病人延误了适合其病情的最后的治疗。这种情况可能导致在前列腺(膀胱肥大,肾盂积水,肾盂扩张等)中对继发梗阻损伤的结构的严重损害,从而带来严重后果。此外,相当数量的具有症状足以严重到需要外科干预的病人也不愿冒手术的危险,且很少是前列腺切除术的应试者。另外,患有BPH的又不期望得危险的并发症(如不育症)的较年青的男人通常不得不拒绝外科干预。由此,为了治疗BPH改进外科的和非外科的方法的必要性,重要性和价值是不容置疑的。
高频电流用于切除人体组织的电烧灼手术,特别是要求无出血的切口或者当手术位置不能用通常的解剖刀所能达到的但存在着对于薄的器械能通过的自然的人体开口(如食道、肠和尿道)的入口。例子包括切除前列腺腺瘤,膀胱肿块或肠息肉。在这种情况下,高频电流通过外科探头送入等切割的组织。最终耗散的热量使该位置上的细胞液沸腾和汽化,于是细胞壁破裂,组织被分开。
将细胞组织就地破坏已经单独地或作为辅助外科去除方法用于许多疾病和医疗状态的治疗,它通常比外科方法具有更少的创伤,且可以是在其它手段不安全的情况下的唯一替代。切除治疗装置具有使用通过循环液体和其它中性体过程的传导和对流使破坏能量快速耗散并减少到非破坏程度的优点。
微波,射频,声音(超声)和高能(激光)装置以及组织破坏物质已经用于破坏各个解剖位置和器官的恶性的,良性的和其它类型的细胞和组织。所治疗的组织包括隔离的癌块,而更特殊的器官诸如以良性的前列腺增生为特征的前列腺,腺体和基质结。这些装置典型地包括一个导管或套管,它用于携带一个射频电极或微波触角,通过管道到治疗区域,并使能量扩散地通过所说的管道壁在所有方向上施加在周围组织上。严重的伤害通常是在这种细胞操作过程中由管道壁承受,且某些装置是冷却系统与微波触角(microwave antenna)结合起来的,以减少对管道壁的损伤。为了用这种装置治疗前列腺,例如,热能通过尿道壁传输到围绕前列腺的细胞上,致力于消灭阻塞尿道的组织。光能(典型地是激光)通过“燃烧”尿道壁传输到前列腺组织的目标位置上。健康的管道壁细胞和所说的小结和管道壁之间的健康的组织在手术过程中也被不加区别地破坏,从而可能导致某些前列腺功能的不必要的损失。因此,某些微波装置增加冷却系统可使装置变得复杂,且还要求装置要足够的大以容纳冷却系统。
为了医学上的目的把液体施加到特定的组织上又受到获得不损伤中介组织的传输能力和限于特定目标组织的有效传输能力的限制。局部化疗,药物灌注,胶原注射或注射药剂,通过光、热或化学的方法激活,这些可以通过某种装置大大简化,所说的装置可以方便地和准确地定位在特定目标组织处的液体供应导管道开口上。
发明内容
本发明的主要目的在于提供一种把可控的热量通过中介组织而对这些中介组织实际上不存在加热或影响地传输到目标组织上的方法和设备。所述的目标组织是依据医学上的作用选择的,如组织破坏。所说的破坏限于准确预选的位置,以使损伤最小且达到较好的医学效果。
本发明的另一个主要目的在于提供一种通过把治疗能量直接输送到目标组织的用于人体组织的精确组织破坏而又对其周围组织影响最小的方法和设备。
本发明的又一个目的是提供一种自动控制的热破坏方法,以便当周围的环境超过预定温度时能关闭。
本发明的又一个目的在于提供一种用于将传输的能量按预定的时间周期限定在特定频率范围内并限定在特定的功率范围上的系统,以便把靠近组织的温度控制到目标组织温度并提供能量传输参数,因此,施加的能量不会影响在前列腺附近的人体器官且也不影响在所说的前列腺附近的任何神经系统元。
本发明的再一个目的在于提供一种在选择的电压和选择的频率范围上通过导管输送的定时施加的RF(射频)能量。所使用的该类导管包括一个在侧壁内具有装有至少一个探针孔的探针引导壳的探头和用于按预选的角度把可弯的探针通过探针孔和周围组织引入目标组织的引导装置。
本发明还有一个目的在于提供一种通过使用装在可弯的探针近端和探针口近端的热传感器监测导管探头端周围温度的方法和系统,其中,这些热传感器中的每一个具有一个反馈指示温度的显示装置。本发明还包括当热传感器的任何一个的温度超过每个相应的热传感器预定的最大值时切断RF能量。
本发明再一个目的在于提供使用另外的传感器测量在病人人体器官附近的温度,以便监视在靠近人体部分上的RF能量施加的效果。
本发明再一个目的在于提供一种基于校正的能量传输的电压传输系统和方法,所说的能量校正是基于典型的人体阻抗。
本发明的再一个目的在于提供一种用于按预定的时间间隔施加可控RF能量的方法,该方法具有基于把安全温度限制在导管传输RF电压的最接近的环境和限制在接近前列腺区域的人体器官的范围内的自动切断部分。
附图说明
图1是表示按照本说明的方法的优选实施例配置的导管和具有导管传输能量的前列腺探头的男性下部解剖的剖视图;
图2是利用本发明的能量施加装置的两个探针的RF切除(ablation)导管实施例的顶视图;
图2A是非传导的套覆盖在图2的每个探针上的侧视图;
图3是用于本发明方法的传输系统的电源部分的示意图;
图4是按照本发明的能量传输系统的前面板的视图。
实施本发明最佳方式
本发明的方法提供了一种精确可控地把RF能量传输到作为治疗或破坏被瞄准的组织的方法。所产生的能量通过具有探针的导管输送,该导管包括适合于从导管口经正常组织到目标组织的实心的或空心的探头。典型的探针是共同未决的专利申请号为07/929,638和08/012,370所公开的形式,探针的形状应该有利于通过组织,它可以是细的丝或杆,或者可以是具有能引入液体或能排出物质的具有纵向腔的细的中空管或其它形状。探针通常且最好是尖的,以便当它通过组织推入目标位置时能减少阻力,按照本发明的探针被设计成射频电极。
本发明提供了一种改进的用于破坏整个人体的医学上被瞄准的组织的细胞的精确可控的医学治疗方法。这些细胞可以是在特定的人体器官之内或之外。更特殊地,所述的方法和装置用于把传输的能量供治疗良性前列腺增生(BPH)用,而所述的装置和如在优选的实施例中所描述的它的用途是专门相应于BPH设计的。本专业的技术人员应该容易明白,本发明的方法和装置可以通过经皮的或内窥镜的导管用于破坏人体组织和可接近的任何其它的体腔或组织部位,且不限于前列腺。本发明的装置和方法在所有这些器官和组织中的应用都意味着包括在本发明的范围之内。
BPH是由在前列腺中的细胞的良性复制和增生所引起的一种状态,形成使前列腺扩张和使修复的尿道的开口阻塞的腺体和基质小结,腺小结主要集中在过渡区域,而基质小结则在尿道周围的区域。对这种情况传统的治疗包括外科切除整个前列腺,指(趾)的腺瘤切除,同样还有经尿道的尿道管和前列腺切除术,以便切除组织和加宽通道,一种明显的与后一种方法相关联的严重的并发症是医原性的不育。最近,激光治疗已经应用于切除组织,它限制了出血和体液的损失。气囊也已用于尿道扩张,以增加它的直径,这当中有用加热装置的,还有不用加热装置的,但业已发现,它们都有明显的局限性。
微波治疗通过把微波触角定位在修复的的尿道内并在围绕尿道的组织内由微波场产生热已获得了一定的成功。有时把冷却剂施加在导管轴上,以便降低尿道壁的温度。这就需要复杂的机构,以便对较近的组织提供冷却,而又同时为较远的修复组织产生热。这种技术与微波发热相似。同样地,用位于尿道内的电极进行射频组织破坏具有有限的适用范围,因为它必需把尿道壁暴露到破坏温度下。为了防止这种情况,需要低温设置以便保护尿道,由于温度如此低,因此为产生有用效果所需的治疗时间非常长(例如,能量施加达三个小时)。
在本发明的优选实施例中,使用的尿道应靠近前列腺,且把RF探针直接定位在欲破坏的组织或小结内。从尿道延伸到目标组织的探针的导体部分应封入纵向上可调节的套内,该套防止把靠近套的组织暴露在RF电流之下。因此,切除的破坏应限于作为破坏而应瞄准的组织,即引起阻塞的那些组织。更特殊地,按照本发明的把能量传输到电级的方法,探针被控制在一定的功率范围和一定的频率范围内,且由装在靠近探针的一系列温度传感器限制,以便保证全面地保护周围的组织。这是可以通过基于任何一个传感器显示的超过所治疗区域的预定的安全温度自动切断到系统的RF能量实现的。该方法还具有如下的特征,自动切断供给系统的能源使用了装在被治疗组织附近的人体器官近处的另外的传感器,以避免由于提高器官温度所引起的对那些邻近人体器官的损坏。
图1是一个典型装置使用时的男性下部解剖的示意剖面图,该装置用于把按照本发明的方法和设备产生和传输的可控的能量施加到被治疗的组织上。尿道2从膀胱4通过前列腺6和泌尿生殖器隔膜8延伸。BPH是一种状态,其特征在于修复的尿道部分的阻塞主要是由于在前列腺内的良性的腺体和基质细胞增生引起的,这些小结向内压迫尿道壁限制尿道直径,且可能时常向外压迫正常的组织使前列腺增大。传统的治疗(切除前列腺的缺点)包括或者是通过切除术或激光使组织破坏去除尿道上的组织以扩大尿道腔,或者是通过对尿道周围的组织的扩张并加热到使细胞能损坏的温度。后一种方法意图减少前列腺的增大或扩大,把尿道至少部分地修复到它原来的直径。
带探针引导装置16的导管14向下通过尿道进入前列腺。引导装置16的位置,例如,使用从通过肛门口22插入靠近前列腺的直肠20的传统的超声传感器(Ultrasonictransducer)18所接收到的信号获得的超声成像准确控制。引导装置可以在超声成像之下很容易地把探针17定位在准确位置上。引导装置18还可以包含传感器37,38和39,它们在肠区域内,由于显示下面将要说明的对加热组织的效果。可选择地是在超声探头取出后和导管14和探针引导装置16已定位后,传感器37、38和39也可以是独立器械的一部分装在直肠区域内。图1所示的是两个探针306和308,且探针306的端部已穿入组织区域170,该区域表示待切除的组织。
图2是图1切除导管的两个探针的实施例的顶视图,用于按本发明优选的方法和装置传输能量。装在手柄302上的可弯曲的导管300具有端部探针引导装置304,其上有两根探针306和308,手柄具有探针套帽356和电极帽354,手柄还有在下面将详细说明的连接到RF源的连接器303。图中还示出了与热连接器307的连接。导管300从手柄302引出到探针引导装置304的这一部分可以选择为具有分级的刚性,例如,导管可以设计成在靠近手柄处有较大的刚性,而在靠近端部有较大的可弯曲性或所要求的任何其它的刚性。导管可以如共同未决的1991年8月11日申请的申请号为790,648所公开的内部带槽的不锈钢管和可弯曲的外套构成,该申请的全部内容在此作为参考文献引入。它也可以通过把外套连接到卷绕的或编织的丝上组成。图2的探针在共同未决的1993年2日2日申请的申请号为08/012,370中已经说明。
本发明的能量传输方法可以通过在图3示意表示的能量供给传输系统实现。
标记210的方框示出了按图1相同的方式将插入的探针引导装置16和具有传感器37、38和39的传感器探头18连接到病人身上。探针引导装置16具有二个探针以及在图中所示的分别装在探针附近的传感器241和243。更特殊地,在一个优选实施例中,图2的探针306和308每一个包括一个如图2A所示的非导体的套,该套在共同未决的专利申请号08/012,370中已有详细的讨论。对于本申请来说,非导体的套具有一个成锥形的引导端262和一个刚性的近端264。非导体的套202的中心部分或内腔274接纳探针306,308。温度传感器241装在引导端上。图3中示意地所示的传感器243相应于另一个探针,且应该与传感器241的位置一致。在探针引导装置中所示的第三个传感器以标242表示,且相应地位于引导装置内部靠近表面处。所示的探针引导装置具有三个传感器241-243,它们分别通过隔离装置231-233送出温度信号,以便分别在221,222和223进行温度测量。
探针306和308的加热是通过图3中示意地所示的晶体振荡器102和转换电路104产生的RF能量实现的。在一个优选的实施例中,晶体振荡器有效地把482KHzrf(射频)能量输送到探针引导装置,更特殊地,分别输送到两个探针306和308上。转换电路由100欧姆的阻抗校正,阻抗是基于病人尿道中按探针位置的测量值预期的典型中值阻抗。在图3的电路实际操作时,阻抗随校正的阻抗变化,且由电路204测量。由于rf能量的传输是单极的,因此每个病人必须具有一个惰性电极206才构成完整的电路。典型地,这些电极是放在病人背上并粘结保持的大的连接板。
在一个优选的实施例中,转换电路能够达16瓦,尽管在BPH中所遇到的被隔离的组织切除所施加的正常范围在5到7瓦之间,典型的持续期为3分钟。
对电路操作上的限制,除操作员的设定和频率及能量的最大值外,由与探针引导装置16有关的传感器241,242和243和与直肠探头16有关的传感器37,38和39的输出处理分别与由绝缘装置231到236和温度测量装置221-226所示的是相同的。绝缘装置231-236包括一个1500伏的绝缘电路,在一个优选的实施例中它是一种Burr-Brown绝缘器件ISO-122JP。绝缘装置231-236的输出通过冷端温度补偿器271-276馈送到温度测量电路221-226和温度切断电路211-216。绝缘装置231-236的每一个象温度测量装置221-226一样是相同的。每个冷端温度补偿器271-276提供了以摄氏温度表示的绝对温度测量读数。虽然电路对于温度切断电路211-216的每一个是相同的,但这些切断电路的每一个具有不同的温度限制,或者可以具有不同的限制。基于生理评估,为了保证在被破坏的组织周围和在附近的器官中不过分过热,进一步的限定已经确定,以便对病人进行保护。对于电路211和212切断的传感器对应于传感器241和243并设定90℃为切断温度。为了便于说明,60℃的温度足以保证组织的蛋白质相移(dephasing),该相移保证了组织的破坏。由传感器242检测到的引导装置16中的温度由切断电路213设定,且温度为45℃。这样保证了装有引导装置的尿道不会受到损害。换言之,如果温度保持在45℃或低于45,尿道内的结构将不会破坏。必须注意,如果任何一个切断电路工作,那么,整个系统将不管操作人员的任何决策都将自动地切断。由此,如果传感器241或243之一达到90℃,或如果传感器242达到45℃,那么装置都将切断。
如前所讨论的,典型地装在直肠探头16内的传感器37、38和39的目的在于防止邻近器官的损坏,特别是保护肠不过热。在一个优选的实施例中对于每个传感器37、38和39这个温度设定为40℃,40℃是稍高于人体正常温度(37.5℃)的温度。由此,一旦任一传感器37、38和39再次超过它们的预定切断限制,把能量传输给探针306和308的整个操作都将停止运转。
在图3中还可以看到的是重复率调节器245,该调节器可以用于提供脉冲输出的能量输送以便基于生理上的考虑便于按时间变化传输能量。脉冲输出的能量输送能以电子脉冲提供调节施加能量之间的间隔的能力,以便使能量突发,该突发能量当短时间施加时不会使温度传感器超过它们的预定值,而且传输足够的能量破坏所选择的在探针周围的组织区域内的细胞以造成损伤。在施加这个峰值能量之后,在下一个峰值之前的间隔内使总的施加能量保持该值,以致不影响邻近的组织区域或邻近的器官。换言之,使用电子脉冲提供了一种用于施加峰值能量以便在短时间内取得局部破坏效果的机会,而同时又限制了在预定期间内的总的能量,以便除要求损伤的区域和其它人体器官外不会明显地影响其它组织块。峰值在可控的短时间内施加,且具有可控的最大值,因此,在整个周期中,例如,三分钟,总的能量或者与连续施加的能量相同或者低于它,施加的总的能量估计不会触发任何温度传感器的切断开关。
电子脉冲提供了一个机会,当需要时和当要求时,能够更有效地破坏在一个非常局部的所瞄准的区域内的细胞,且仍能保持本发明的方法和设备的安全性。传感器的温度限制不会被超过是因为,正如上面所指出的,总的施加的能量不会高于连续工作时所施加的能量。
对施加电子脉冲的监视可以人工地通过观察在监视器上的温度实现。亦即,操作员可采用观察温度的方法到切断限值时就停止施加能量,直到冷却下来,然后重新脉冲供能。另一方面,这种监视也可以电子方式通过由控制要求破坏的特定细胞区域所需要的峰值能量的预置参数和接着电子监视升温和降温速度来实现。这些电子脉冲步骤无论是由人工完成的或者是以电子方式都是基于人的生理上的考虑完成的,它们都不会影响病人的安全。如果这些温度传感器中的任何一个,无论是在靠近探针的组织的,或者是在尿道内的导管引导装置中的,或者是靠近人体器官的超过预置的安全温度,每个温度切断开关仍具有自动地切断整个能量供应的功能。电子脉冲无论是人工完成的或者是通过电子生理方案完成的都提供了一种通过脉冲重复率调节器245取得对目标块组织破坏的最大效果而对周围的组织和相邻的人体器官无副作用的机会。
现在结合图3和图4表示操作系统的优选实施例的图4前面板的讨论按照本发明的方法的能量传输系统的操作。图3和图4的关系是这样的,即图3是标有A-I的各个测量项目的输出指的是在图4电源前面板中的显示A-I。显示A表示由操作人员设定的功率,特别是由电源和转换电路104供给的能量。还有另一个能量显示B,它是显示实际输送能量的。如前所讨论的,电源是通过100欧姆的阻抗校正的。100欧姆的阻抗和特定病人之间的任何差异都将引起在显示A设定的功率和由电路203实际传输和测量并在B上显示的功率之间稍稍的变化。为了检测电路的完整性,阻抗测量装置204把阻抗显示施加到在装置前面的显示屏C上。余下的与温度测量装置221-226有关的显示D-I提供来自探针引导装置16每个传感器241-243的和来自探头18的每个传感器37-39的温度在前面板上显示。在图4监视传感器的前面板上的适当的标签可以立即识别。必须强调,操作人员的温度监视与切断电路211-216的操作完全无关,正如前面已经指出的,所述的电路自动地关闭装置,而与操作人员所采取的任何行动无关。无须进一步的操作或重新起动,直到传感器的温度降到切断限制值以下。
在一个优选的实施例中,连接器47和48提供了与不同探头的连接,且连接器47之一提供了把能量传输到探针的输出,同样,提供一个传感器连接,以便接收来自三个传感器241,242和243的温度信号,单独的连接器48接收来自传感器37,38和39所传输的温度信号。
虽然已经说明了与探针引导装置有关的三个传感器和与直肠探头18有关的三个传感器,但可以容易看出,另设的传感器或不同配置的传感器可以和按公认的在人体其它部分上温度引起的生理结论设定的切断温度极限一起使用。
此外按照优选的实施例,传感器37-39和241-243是热电偶,尽管其它形式的温度传感器也可以考虑。
由图3和图4的优选实施例输送的RF能量频率,如前所述为482KHz。其它频率也是可以用的,其范围由实际上不影响体内,特别是在电流流路内的神经系统或任何敏感器官的任何生理变化的频率决定。基于这些考虑,频率范围大约从250KHz向上延伸,这样做仅仅是为避免信号频率上的伤害。当然,要避免的另一伤害是施加高电压和大功率引起的,特别是必须避免可能造成严重伤害的大功率波动。在电外科中,当特定的阻抗由于组织破坏的结果大大地变化时,这种大功率波动很易于发生。阻抗的这种快速变化产生了非常高的电压,这种非常高的电压对附近的神经系统元和周围器官的功能可以造成严重的损害,导致不能被人接受的阳萎情况的出现。
本发明的功率传输方法避免了阻抗值的这种激烈的变化,且特别是基于在电路中的阻抗无明显变化的连续输送的恒值能量,从而避免了电力的波动。
在前面讨论的通过重复调节的脉冲操作提供的另一个实施例中,在明显的时间周期内的总能量实际上保持常值,而阻抗值保持常值与那种电外科手术成鲜明对比,所说的电外科由于阻抗击穿导致瞬时达到能量峰值,所述的阻抗击穿通常发生在电外科操作时没有可靠的反馈控制的情况下。
按照本发明的实施例在所要求的术区的组织切除由于通过低功率的基本恒定能量输送的探针的方式精确施加,结果是对毗邻的健康组织和对附近的神经系统元和人体器官的影响最小。
使用图3和图4的能量输送系统的治疗BPH的方法,包括操作员把5瓦到7瓦之间的能量施加3分钟,接着将一个或多个探针移到另一个术区,之后以相同的能量范围再施加3分钟。施加的次数由被切除的组织的量和位置决定。在每次手术时,温度切断限制电路对于由于任何非预期的温度的上升现象起所需要的保护,温度限制保证了被治疗的组织周围环境的控制,同样还有尿道和任何毗邻的器官。相邻的器官相应于温度上升的保护是通过与传感器37,38和39有关的温度切断限制提供的。
显然,本发明的许多变换和改变接照上述技术是完全可能的。因此,应该明白,本发明可以除如在此详细描述的之外实施,但它们都在所附的权利要求书的保护范围之内。
Claims (23)
1.一种无需暴露目标组织块周围组织而以破坏性的温度热治疗目标组织块的方法,包括如下步骤:
把导管引入所说的目标组织附近的区域,把从所说的导管中突出的可弯曲的探针插入所说的目标组织块;
通过所说的探针把从不能电损伤人体神经系统的频率范围内所选频率的可控的射频能量传送到所说的目标组织块上;
把所说的可控射频能量保持在一定的能量水平上并保持足以使所说的目标组织切除的预定时间;
在所说的传输能量过程中,监视至少一个在靠近所说的目标组织的组织区域的至少一个温度;和
当所说的至少一个监视温度的任何一个超过相应的一个预定值时,自动停止所说的能量传输。
2.按照权利要求1所述的方法,其中保持所说的可控射频能量的步骤包括把所说的基本上常值的能量保持在操作员可选择的能量水平上。
3.按照权利要求1所述的方法,其中所说的可控的能量传输包括一个以基于预定的已知阻抗值校正的功率值传输能量的步骤。
4.按照权利要求1所述的方法,其中所说的目标块位于男性的前列腺内,而且所说的导管引入步骤包括把所说的导管定位在所说的男性的尿道内的步骤。
5.按照权利要求4所述的方法,其中所说的把所说的导管定位的步骤包括超声监视所说的导管位置的步骤。
6.按照权利要求5所述的方法,其中超声监视的步骤包括把超声探头插入所说的男性的直肠区域的步骤。
7.按照权利要求1所述的方法,其中监视至少一个组织的至少一个温度的步骤包括在靠近所说的探针处提供传感器的步骤。
8.按照权利要求1所述的方法,进一步包括监视至少一个在所说的目标组织块附近的人体器官的温度的步骤,当所说的被监视的邻近器官的温度超过预定的安全器官温度时自动停止能量传输。
9.按照权利要求8所述的方法,其中所说的监视邻近器官温度的步骤包括把含有至少一个用于提供所说的监视所说的邻近的人体器官的传感器的温度探头插入男性直肠腔内的步骤。
10.按照权利要求1所述的方法,其中所说的可控的射频能量的频率是在250KHz以上,所说的基本上恒定的能量的功率为5至7瓦,而且所说的可控射频能量传输2到3分钟,以便保证目标组织块的去除而不超过邻近组织的破坏温度。
11.按照权利要求1所述的方法,其中保持所说的可控射频能量的步骤包括调节所说的能量重复率的步骤,以便提供一个能量脉冲,该能量脉冲具有的按预定的时间所传输的整个能量大致等于或小于的恒定的能量值传输的能量,其中所说的脉冲的能量峰值,每个脉冲宽度和脉冲间的间隔是一种所说的在人体内的目标组织块的位置、程度和生理性能的函数。
12.一种用于无需暴露邻近组织块并以破坏性的温度加热治疗目标组织块的设备,所说的设备包括:
导管设置,包括用于把至少一个探针输送到所说的目标组织块内的引导装置,其中所说的导管放在邻近所说的目标组织块的区域内;
能量传输装置,连接到所说的至少一个探针上,用于把从不能电损伤人体神经系统的频率范围内所选频率的可控射频能量传输到所说的探针上;
用于把所说的可控射频能量保持在一定能量水平和预定时间用以使所说的目标组织去除的装置。
第一温度监视装置,该装置连接到所说的能量传输装置上并响应于在所说的能量传输到所说目标组织的操作期间的至少一个邻近所说目标组织块的温度,其中当所说的至少一个被监视的温度的一个超过相应的预定值时所说的监视装置提供切断所说的能量传输装置。
13.按照权利要求12所述的设备,其中所说的能量传输装置包括一个基于有关正常男性阻抗值校正的校正电源。
14.按照权利要求12所述的设备,进一步包括第二温度监视装置,它用于监视在所说的目标组织附近的包含至少一个传感器装置的人体器官的温度。
15.按照权利要求14所述的设备,其中所说的传感器装置插入直肠区域,以便在所说的能量传输装置工作时监视肠内温度。
16.按照权利要求12所述的设备,其中所说的能量传输装置包括一个晶体振荡器和一个转换器装置,它用于把预定能量水平范围内的能量传输到所说的探针上。
17.按照权利要求16所述的设备,其中所说的能量传输装置进一步包括多个温度测量电路,所说的温度测量电路的每一个连接到相应的传感器和所说的转换器电路上,以使当所说的温度测量电路的任何一个超过相应的指定的预定温度值时,切断输送到所说探针上的能量。
18.按照权利要求17所述的设备,其中每一个所说的温度测量电路包括绝缘(isolation)装置和冷端温度补偿器。
19.按照权利要求12所述的设备,进一步包括连接到所说的能量传输装置上的重复率调节装置。
20.按照权利要求12所述的设备,其中所说的能量传输装置包括一个用于提供基本上恒定的操作员可选择的能量水平上的所说能量的装置。
21.一种用于通过带有至少一个可调节的突出探针的可弯曲的导管提供目标组织治疗的自带电源和监视站,包括
电源(power supply)装置,用于把从不会电损伤人体神经系统的频率范围内的频率可控的射频能量输送到所说的探针上,其中所说能量值足以去除(ablate)所说的目标组织,所说的电源装置进一步包括多个温度测量和控制电路,所说的温度电路的每一个包括用于监视传感器温度的装置和用于当所说的电路的任何一个超过相应的预定温度值时切断所说电源的操作的装置;
用于监视由所说的电源,所说的探针和含所说的目标组织的人体构成的电路阻抗的装置;
用于显示所说的阻抗和由每个所说的温度测量电路测量的温度的装置;
操作员控制装置,用于设定由所说的电源传输的能量,并用于调节传输到所说的至少一个探针上的能量。
22.按照权利要求21所述的设备,其中所述的电源装置包括一个用于对所说的至少一个探针提供脉冲能量输出的重复率调节装置。
23.按照权利要求21所述的设备,其中所说的电源装置的基本上常值操作的可选择的值提供的所说的能量。
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US08/061,072 US5385544A (en) | 1992-08-12 | 1993-05-14 | BPH ablation method and apparatus |
US08/061,072 | 1993-05-14 |
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CA (2) | CA2162887C (zh) |
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WO (1) | WO1994026178A1 (zh) |
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1994
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- 1994-05-13 AU AU69087/94A patent/AU680509B2/en not_active Ceased
- 1994-05-13 AT AT94917334T patent/ATE228800T1/de not_active IP Right Cessation
- 1994-05-13 JP JP6525623A patent/JP2647557B2/ja not_active Expired - Fee Related
- 1994-05-13 WO PCT/US1994/005141 patent/WO1994026178A1/en active IP Right Grant
- 1994-05-13 KR KR1019950705153A patent/KR0181538B1/ko not_active IP Right Cessation
- 1994-05-13 CA CA002162887A patent/CA2162887C/en not_active Expired - Lifetime
- 1994-05-13 EP EP94917334A patent/EP0697837B1/en not_active Expired - Lifetime
- 1994-05-13 DE DE69431838T patent/DE69431838T2/de not_active Expired - Lifetime
- 1994-05-13 CA CA002275162A patent/CA2275162C/en not_active Expired - Fee Related
-
1995
- 1995-01-05 US US08/368,936 patent/US5540655A/en not_active Expired - Lifetime
-
1996
- 1996-05-23 US US08/652,775 patent/US5865788A/en not_active Expired - Lifetime
- 1996-05-23 US US08/652,783 patent/US5843026A/en not_active Expired - Lifetime
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN104582619A (zh) * | 2012-04-26 | 2015-04-29 | 麦德托尼克消融前沿有限公司 | 用于检测消融期间组织接触的系统 |
CN104582619B (zh) * | 2012-04-26 | 2018-12-04 | 麦德托尼克消融前沿有限公司 | 用于检测消融期间组织接触的系统 |
CN104981269B (zh) * | 2012-12-21 | 2017-08-04 | 诺斯克投资有限两合公司 | 采用低压等离子体处理生物组织的设备和方法 |
Also Published As
Publication number | Publication date |
---|---|
JP2647557B2 (ja) | 1997-08-27 |
US5540655A (en) | 1996-07-30 |
AU680509B2 (en) | 1997-07-31 |
DE69431838D1 (de) | 2003-01-16 |
EP0697837B1 (en) | 2002-12-04 |
DE69431838T2 (de) | 2003-10-09 |
US5385544A (en) | 1995-01-31 |
EP0697837A1 (en) | 1996-02-28 |
US5843026A (en) | 1998-12-01 |
JPH08508664A (ja) | 1996-09-17 |
ATE228800T1 (de) | 2002-12-15 |
WO1994026178A1 (en) | 1994-11-24 |
KR960702277A (ko) | 1996-04-27 |
AU6908794A (en) | 1994-12-12 |
CA2275162C (en) | 2000-11-07 |
CA2162887C (en) | 1999-08-03 |
KR0181538B1 (ko) | 1999-04-01 |
CA2162887A1 (en) | 1994-11-24 |
US5865788A (en) | 1999-02-02 |
EP0697837A4 (en) | 1997-02-05 |
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