CN101212932A - 经阴道的子宫动脉闭塞 - Google Patents
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Abstract
使用一种工具进行子宫动脉闭塞以治疗子宫纤维瘤,其中通过阴道壁将该工具引入到子宫外部。所述工具带有可以被定位到子宫动脉上的夹持元件。在夹持元件上的电极或其它能量供给装置可以被使用以供给封闭子宫动脉的能量。可选择地,所述工具可以带有超声、视觉,或接近感应器以在供给能量之前检测子宫动脉的存在。
Description
技术领域:
本发明通常涉及医疗装置和方法。特别地,本发明涉及用于进行子宫动脉闭塞以治疗子宫纤维瘤的微创方法和装置。
子宫纤维瘤,也被称作子宫肌瘤,其影响众多女性,尽管大多数的纤维瘤没有症状和不需要治疗。然而,纤维瘤如果快速增长,大到足以移动其他器官如膀胱,则可以造成生育问题或者导致异常出血。
可以使用多种治疗方法治疗子宫纤维瘤,这些治疗方法包括肌瘤切除术、腹腔镜子宫肌瘤切除术、子宫切除术、肌瘤闭塞术和子宫动脉闭塞。本发明主要关注子宫动脉闭塞,其依赖于阻断或闭合向纤维瘤供血的动脉。在透视下将导管引入子宫动脉,将小颗粒注射到动脉中以阻断血流。阻断血液供给可以使纤维瘤缩小以减少或消除症状。
尽管很有前景,血管内闭塞由于一些原因而不太符合需要,这些原因包括失效性和与患者不相容。近来,已经提出了以其它方式闭合子宫动脉,例如可选择地在直肠或其它显像下,使用穿过子宫壁被引入的射频消融针(radiofrequency ablation needle),。美国专利No.6,905,506描述了一种用于夹紧子宫颈以暂时闭合子宫动脉和使得纤维瘤缩小的阴式方法。然而,这些方法中没有一种完全有效或者适于所有患者。因此,仍旧需要提供可替代的方法学、方法和装置以通过子宫动脉闭塞实现纤维瘤的治疗。
背景技术
美国专利No.6,905,506描述了使用通过阴道引入到子宫颈的夹子以可逆地收缩子宫动脉的方法。在美国专利6,059,782和5,746,750中描述了具有射频电极的夹持装置。美国专利6,059,766描述了一种拴塞治疗方法,其将闭塞元件通过子宫壁引入到子宫动脉中。下述美国专利也与本发明相关:3,920,021;3,845,771;4,041,952;4,671,274;4,972,846;5,037,379;5,078,736;5,151,102;5,178,618;5,207,691;5,217,030;5,267,998;5,269,780;5,269,782;5,281,216;5,282,799;5,290,287;5,295,990;5,300,087;5,324,289;5,330,471;5,336,229;5,336,237;5,342,381;5,352,223;5,352,235;5,356,408;5,391,166;5,395,369;5,396,900;5,403,312;5,417,687;5,423,814;5,445,638;5,456,684;5,458,598;5,462,546;5,482,054;5,484,435;5,484,436;5,496,312;5,496,317;5,514,134;5,531,744;5,540,684;5,540,685;5,542,945;5,549,606;5,558,100;5,558,671;5,569,243;5,573,535;5,578,052;5,599,350;5,603,711;5,611,803;5,624,452;5,637,110;5,637,111;5,653,692;5,658,281;5,665,085;5,665,100;5,667,526;5,669,907;5,674,184;5,674,220;5,681,282;5,683,385;5,683,388;5,688,270;5,693,051;5,697,949;5,700,261;5,702,390;5,707,369;5,709,680;5,713,896;5,718,703;5,733,283;5,735,289;5,735,848;5,735,849;5,741,285;5,743,906;5,755,717;5,833,690;6,602,251;6,743,229,6,746,488;和US2001/001480。
发明内容
本发明提供了用于实现子宫动脉闭塞以治疗子宫纤维瘤的改良的方法、装置和系统。根据本发明的方法,将一种工具通过阴道壁推进子宫动脉(或其它流入子宫的动脉),该工具用于收缩和供给能量以使子宫闭合。优选地,将该工具经阴道引入与子宫颈相邻的阴道壁的位置,典型地在阴道穹窿处或其附近。典型地,在直接显像下,使用常规的手术器械通过一个、两个或多个小切口将阴道壁穿透。可选地,被引入的工具自身具有诸如刀片、电外科学的针尖等的穿透元件以使该工具通过阴道壁被直接引入而不需先切开。
在通过阴道壁将该收缩工具引入后,其将向子宫或其它靶动脉推进。优选地,在动脉收缩和/或供给能量之前,与子宫动脉相邻的该工具的位置将被确认。可选择地,当该工具被适当定位时将给出视觉或听觉信号。确认可以包括以多种方式中的任何一种观察到该工具和/或子宫动脉。例如,可以根据常规妇科方法使用腹腔镜显像确定该工具相对于子宫动脉的位置。或者,可以使用体外超声、荧光透视(fluoroscopy)或其它显像法来确认该工具相对于子宫动脉的位置。或者,除了体外超声、荧光透视或其它显像法,该显像工具可以带有其自己的视觉或超声显像元件以确认其位置。在任何情况下,在该装置被适当地定位后,其被用于子宫收缩和向子宫或其它靶动脉供给能量以实现闭合。
在更进一步的实施方式中,本发明的装置可以依赖于血流检测以确认接近于靶动脉。在这些实施方式中,一种多普勒(Doppler)超声元件将被放置到该工具远端处或附近,和动脉的存在可以被常规超声检测和方法所检测。其它用于确认位置的方法包括接近传感、压力传感等。
在示例性实施方式中,所述工具包括影响子宫动脉夹持的对置夹持元件。所述夹持元件典型地带有电极或其它能量(或冷冻疗法)供给部件以允许动脉被夹持元件短期夹紧时,使动脉永久闭合。当动脉腔(artery lumen)封闭但保持动脉的其它方面原封不动的条件下,该能量将被使用以避免止血的需要。该要被供给的能量优选地为射频(RF),但包括热能、超声能、微波能、机械能等的其它能量也可以使用。可选地,该工具可以带有一种或多种紧固件,例如卡子、卡钉、缝合环等,其可以机械地调配以收缩导管。
本发明还提供了用于阴式方法闭合子宫或其它靶动脉的装置。所述装置包括在其远端具有对置夹持元件的轴结构(shaft structure)。该轴结构适于通过阴道壁(优选地通过阴道腔)被定位到其与子宫动脉相邻的远端位置。所述夹持元件具有电极或其它结构,当子宫动脉在其中被夹紧时,所述电极或其它结构向子宫动脉供给能量。优选的能量供给结构是射频电极,但是其它结构也适用。
在一个示例性实施例中,所述轴包括一对铰接臂,其每一个都带有至少一个电极,优选地为可与单极或双极电源相连的射频电极。在一个优选实施例中,所述臂中的至少一个也将带有显像或多普勒(Doppler)超声元件以允许确认该夹子与子宫动脉相邻。
在一个替代的实施方式中,所述轴可以基本上由单独管状元件所组成,其具有可向其中推进的夹持元件。由于更容易通过在阴道壁上的小型切口而引入并且不需要像在铰链的实施方式中一样打开或关闭所述臂,使用该单独管状元件是有益的。
也可以使用各种其它夹持机构,包括平行四边形机构,双金属驱动器、螺线管装置、电动操纵器等。
本发明还提供了用于闭合子宫动脉的系统,其中该系统包括上述的任意装置以及电源和控制单元,其通过在装置上的能量供给工具供应能量。所述电源典型地被配置成供给射频能量,但是上述任何其它能量源也可以适用。该系统进一步包括多普勒(Doppler)或视觉显像或传感系统,其用于在治疗前确认存在与子宫动脉相邻的装置。
附图说明:
图1示出了右侧和左侧子宫动脉相对于患者的阴道和子宫的位置;
图2示出了根据本发明的原理相构造的第一示例性治疗工具;
图3A和3B示出了图2的工具的远端沿着线3-3的剖开的替代构造;
图4A和4B示出了本发明治疗工具的替代实施例;
图5A-5E示出了图2的工具根据本发明的原理被用于子宫动脉闭合。
发明内容
根据图1,患者的右侧子宫动脉RUA和左侧子宫动脉LUA从右侧和左侧髂内动脉(IIL)分支并沿着中间平滑肌(medial plain)进入子宫壁。本发明为接近子宫动脉或其它靶动脉的做准备,其通过阴道放置一种工具,经阴道向上推进该工具到与子宫颈C相邻的穹窿(fornix)F中。
可以使用多种工具以接近并穿透子宫壁穹窿F的区域以到达子宫动脉UA。参考图2、3A和3B,第一装置10包括一对铰接臂12和14,其具有远端夹持元件16和18,这在图2中被最好地显示。所述远端夹持元件16和18携带有在子宫动脉在其中被夹紧时向子宫动脉供给能量(或冷却)的机构或结构。在示例性实施例中,该机构包括一对适于供给射频能量的对置的电极20,该能量可以从电源和连接到装置10上的控制单元30中通过导线32被传递(图2)。
优选地,所述夹持元件16和18还包括用于确认接近子宫动脉UA的机构或结构。如图3A所示,一对超声换能器36和38被固定于接近电极20的位置上。该超声换能器优选地配置成检测通过子宫动脉UA的血流的多普勒超声,以产生简单的视觉或听觉信号从而确认该装置的放置。可选地,所述超声元件可以常规方式用于超声显像,或者可以在一些情况下包括光学图像部件,例如光纤、CCD’s等。再或者,当夹持元件36和38接近子宫动脉UA时,可以用接近传感器、压力传感器或其它可以提供视觉或听觉反馈的装置来检测子宫动脉的存在。
作为图3A的远端的替代,图3B描述了夹持臂16’和18’,其中电极20和超声换能器36和38相互堆叠而不是在轴向上互相靠近放置。
为了实施本发明的方法可以配置许多其它的特殊装置。例如,如图4A和4B所示,治疗装置50可以用作具有至少一个腔54的管的单轴52。在接近轴的远端58处设置有一个凹口56,滑动夹持元件60可以通过腔54并具有远端62和/或通过凹口56的进距(advance)。如图4B所示,夹持元件60的远端62可以包括电极70或者其它能量供给部件。类似地,电极72或其它能量供给部件也可以被放置到轴52中凹口的远端表面上。优选地,沿着凹口56的轴向壁可以设置超声或者其他的位置传感器80,以当子宫动脉在凹口56中时检测子宫动脉UA。如图4B中的虚线所示,子宫动脉的夹持可以通过向远端方向推进夹持元件60而实现,以压缩电极70和72之间的子宫动脉。然后可以将射频或其它能量传送到子宫动脉中以便使腔融合并引发子宫动脉腔的闭合。
参考图5A~5E,下面描述根据本发明的原理利用装置10闭合子宫动脉UA。首先,如图5A所示,治疗医生使用常规的工具和技术通过阴道V观察子宫颈C。在阴道壁后部的穹窿F的区域可以开有一个或多个小型切口I。如图5B所示,该切口I延伸到在子宫U底部的阴道V的外部,切口I相对地更接近左侧子宫动脉LUA。
如图5C所示,夹持元件16和18将被通过切口推进以便使其位于左侧子宫动脉LUA的前面和后面。图5D也示出了可替代的视图。然后如图5E所示,操作臂12和14以在子宫动脉LUV上收缩夹持元件16和18。通常在夹紧之前,通过该装置带有的多普勒或其它超声元件确认夹持元件16和18的正确定位。假设定位正确,如图5E所示,子宫动脉被夹紧,并供给能量以便子宫动脉腔的永久融合(fuse)和闭合。尽管能量的类型和用量可以广泛变化,介于5W~300W之间的功率尤其是介于10W~50W之间的功率的射频能量,持续1秒~30秒足够实现永久闭合。
闭合以后,对于带有多普勒超声的装置,在通过切口I和阴道开口撤出该装置前,可以确认流经动脉的血液已经停止。然后可以封闭切口I并结束操作程序。
上面是对本发明优选的实施例的完整说明,但也可以使用它的各种替代、改变或等效物。因此,上述说明不被作为对在权利要求中所限定的本发明的范围的限制。
权利要求书(按照条约第19条的修改)
1. 一种用于治疗子宫纤维瘤的方法,所述方法包括:
通过阴道壁向供给子宫的动脉推进一种工具;
使用所述工具收缩并供给能量以闭合动脉,
其中,使用所述工具包括在动脉腔封闭但保持动脉的其它方面原封不动的条件下,在动脉上夹住包括对置夹持元件的工具并通过该夹持元件向动脉供给能量。
2. 根据权利要求1所述的方法,其特征在于,所述工具通过与子宫颈相邻的阴道壁中的位置推进。
3. 根据权利要求1所述的方法,其特征在于,还包括利用工具穿透阴道壁。
4. 根据权利要求3所述的方法,其特征在于,所述穿透阴道壁的工具和收缩并向动脉供给能量的工具为不同的工具。
5. 根据权利要求3所述的方法,其特征在于,所述穿透阴道壁的工具和收缩并向动脉供给能量的工具为同一个工具。
6. 根据权利要求1所述的方法,其特征在于,还包括在使用所述工具收缩并供给能量以闭合动脉之前,确认所述工具靠近动脉。
7. 根据权利要求6所述的方法,其特征在于,所述确认包括显像所述工具和/或动脉。
8. 根据权利要求7所述的方法,其特征在于,所述显像包括动脉的腹腔镜显像。
9. 根据权利要求7所述的方法,其特征在于,所述显像包括使用超声或荧光透视的体外显像。
10. 根据权利要求7所述的方法,其特征在于,所述显像包括使用超声的直肠显像。
11. 根据权利要求7所述的方法,其特征在于,所述显像通过使用显像元件进行,该显像元件设置在用于收缩并供给能量以闭合动脉的工具上。
12. 根据权利要求6所述的方法,其特征在于,所述确认包括检测所述工具接近流经动脉的血液。
13. 根据权利要求6所述的方法,其特征在于,所述检测使用在所述工具上的多普勒超声元件进行。
14. 根据权利要求1所述的方法,其特征在于,所述工具向动脉供给射频能量。
15. 一种用于闭合供应子宫的动脉的装置,所述装置包括:
轴结构,其通过阴道壁放置,使其远端接近动脉;
对置的夹持元件,其设置在轴结构靠近远端的位置上;以及
工具,当动脉在夹持元件之间被夹紧时,用于从夹持元件向动脉供给能量,
所述轴结构包括两个铰接臂,其每一个都带有至少一个电极。
16. 根据权利要求15所述的装置,其特征在于,至少一个臂带有接近传感器。
17. 根据权利要求16所述的装置,其特征在于,所述接近传感器包括多普勒超声元件。
18. 根据权利要求15所述的装置,其特征在于,所述轴结构基本上由单独管状元件所组成,其内设置有可推进的夹持元件。
19. 根据权利要求18所述的装置,其特征在于,所述管状元件和可推进的夹持元件具有相对的电极。
20. 根据权利要求19所述的装置,其特征在于,所述轴结构还包括接近传感器。
21. 一种用于闭合供应子宫的动脉的系统,所述系统包括:
如权利要求15~20中任意一项所述的装置;
电源和控制单元,通过能量供给工具向动脉供应能量。
22. 根据权利要求21所述的系统,其特征在于,所述电源向能量供给工具供给射频能量。
23. 根据权利要求21所述的系统,其特征在于,所述电源和控制单元还包括接近传感器,当所述远端接近动脉时,所述接近传感器从该装置接收信号。
24. 根据权利要求22所述的系统,其特征在于,当所述能量供给工具被定位到与动脉相邻时,还包括听觉或视觉信号。
Claims (26)
1.一种用于治疗子宫纤维瘤的方法,所述方法包括:
通过阴道壁向供给子宫的动脉推进一种工具;
使用所述工具收缩并供给能量以闭合动脉。
2.根据权利要求1所述的方法,其特征在于,所述工具通过与子宫颈相邻的阴道壁中的位置推进。
3.根据权利要求1所述的方法,其特征在于,还包括利用工具穿透阴道壁。
4.根据权利要求3所述的方法,其特征在于,所述穿透阴道壁的工具和收缩并向动脉供给能量的工具为不同的工具。
5.根据权利要求3所述的方法,其特征在于,所述穿透阴道壁的工具和收缩并向动脉供给能量的工具为同一个工具。
6.根据权利要求1所述的方法,其特征在于,还包括在使用所述工具收缩并供给能量以闭合动脉之前,确认所述工具靠近动脉。
7.根据权利要求6所述的方法,其特征在于,所述确认包括显像所述工具和/或动脉。
8.根据权利要求7所述的方法,其特征在于,所述显像包括动脉的腹腔镜显像。
9.根据权利要求7所述的方法,其特征在于,所述显像包括使用超声或荧光透视的体外显像。
10.根据权利要求7所述的方法,其特征在于,所述显像包括使用超声的直肠显像。
11.根据权利要求7所述的方法,其特征在于,所述显像通过使用显像元件进行,该显像元件设置在用于收缩并供给能量以闭合动脉的工具上。
12.根据权利要求6所述的方法,其特征在于,所述确认包括检测所述工具接近流经动脉的血液。
13.根据权利要求6所述的方法,其特征在于,所述检测使用在所述工具上的多普勒超声元件进行。
14.根据权利要求1所述的方法,其特征在于,在动脉腔封闭但保持动脉的其它方面原封不动的条件下,在动脉上夹住包括对置夹持元件的工具并通过该夹持元件向动脉供给能量。
15.根据权利要求1所述的方法,其特征在于,所述工具向动脉供给射频能量。
16.一种用于闭合供应子宫的动脉的装置,所述装置包括:
轴结构,其通过阴道壁放置,使其远端接近动脉;
对置的夹持元件,其设置在轴结构靠近远端的位置上;以及
工具,当动脉在夹持元件之间被夹紧时,用于从夹持元件向动脉供给能量。
17.根据权利要求16所述的装置,其特征在于,所述轴结构包括两个铰接臂,其每一个都带有至少一个电极。
18.根据权利要求17所述的装置,其特征在于,至少一个臂带有接近传感器。
19.根据权利要求18所述的装置,其特征在于,所述接近传感器包括多普勒超声元件。
20.根据权利要求16所述的装置,其特征在于,所述轴结构基本上由单独管状元件所组成,其内设置有可推进的夹持元件。
21.根据权利要求20所述的装置,其特征在于,所述管状元件和可推进的夹持元件具有相对的电极。
22.根据权利要求21所述的装置,其特征在于,所述轴结构还包括接近传感器。
23.一种用于闭合供应子宫的动脉的系统,所述系统包括:
如权利要求16~22中任意一项所述的装置;
电源和控制单元,通过能量供给工具向动脉供应能量。
24.根据权利要求23所述的系统,其特征在于,所述电源向能量供给工具供给射频能量。
25.根据权利要求23所述的系统,其特征在于,所述电源和控制单元还包括接近传感器,当所述远端接近动脉时,所述接近传感器从该装置接收信号。
26.根据权利要求24所述的系统,其特征在于,当所述能量供给工具被定位到与动脉相邻时,还包括听觉或视觉信号。
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- 2006-06-30 KR KR1020077030817A patent/KR20080027283A/ko not_active Application Discontinuation
- 2006-06-30 CN CNA2006800240155A patent/CN101212932A/zh active Pending
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Also Published As
Publication number | Publication date |
---|---|
EP1898800A2 (en) | 2008-03-19 |
WO2007005791A2 (en) | 2007-01-11 |
US20070005061A1 (en) | 2007-01-04 |
US20070244538A1 (en) | 2007-10-18 |
WO2007005791B1 (en) | 2007-05-10 |
MX2008000369A (es) | 2008-03-07 |
JP2009501029A (ja) | 2009-01-15 |
KR20080027283A (ko) | 2008-03-26 |
WO2007005791A3 (en) | 2007-03-15 |
AU2006265681A1 (en) | 2007-01-11 |
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