CN102438534B - 组织移除系统及组织移除装置 - Google Patents
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Abstract
公开一种组织移除装置。装置包括外管状本体、内管状本体以及内管状本体上的切削刃。外管状本体包括窗口,通过移动切削刃可打开或关闭该窗口。切削刃具有超过内管的材料的硬度。切削刃可以具有至少大约50的洛氏C硬度,而内管具有不大于大约40的洛氏C硬度。切削刃可以通过铣削步骤形成,内管可以通过拉伸步骤形成。可以通过内管以至少大约1.8克/分钟的速率移除被切削刃切断的组织,并且外管状本体可具有不大于大约3.5mm的外径。
Description
相关申请的交叉引用
本申请是2008年4月4日提交的美国专利申请序列号12/098,250(发明名称为“用于组织移除的方法、系统以及装置”)的部分继续申请,该申请在美国专利法35U.S.C.§119(e)下要求2007年4月6日提交的美国临时申请No.60/910,618、2007年4月6日提交的美国临时专利申请序列号60/910,625以及2007年11月9日提交的美国临时专利申请序列号60/986,912的优先权,所有这些申请被结合在此,作为参考。本申请是2008年4月4日提交的美国专利申请序列号12/098,318(发明名称为“用于在执行医疗手术时使用的系统以及适于在所述系统中使用的导引装置”)的部分继续申请,该申请在美国专利法35U.S.C.§119(e)下要求2007年4月6日提交的美国临时申请序列号60/910,618和2007年4月6日提交的美国临时专利申请序列号60/910,625的优先权,所有这些申请被结合在此,作为参考。
技术领域
本申请总体上涉及用于组织移除的方法、系统以及装置,并且更具体地,涉及适合用于子宫肌瘤和其它的异常妇科组织移除的方法、系统以及装置。
背景技术
人们认为子宫肌瘤在相当大百分比的女性人口中发生,可能在所有妇女的至少20%至40%中发生。子宫肌瘤是子宫的平滑肌层中普遍存在的明确的非癌性肿瘤。在许多情况下,子宫肌瘤可以长到具有几厘米的直径并且可以引起如月经过多(延长或大量经期出血)、盆腔压痛以
用于子宫肌瘤的当前治疗包括药物治疗、子宫切除术、子宫动脉栓塞术以及子宫镜切除术。药物治疗通常涉及NSAIDS(非甾体类抗炎药)、雌孕激素组合以及GnRH(促性腺激素释放激素)类似物的应用。然而,当前的药物治疗基本上无效且仅仅是减轻作用。相比之下,子宫切除术涉及从病人体内切除子宫的手术。为此,子宫切除术代表了将子宫肌瘤从病人体内除去的高效途径。因此,在美国通常每年执行几十万例子宫切除术以治疗子宫肌瘤。尽管它们被广泛使用,但是子宫切除术还是具有某些缺点,诸如生育能力的损失、性功能障碍以及诸如出血、损害身体、感染、疼痛以及延长恢复期之类的与主要的外科手术过程通常相关联的风险。子宫动脉栓塞术涉及将导管插入到股动脉中并且接着将导管引导至子宫肌瘤动脉。接着,较小的颗粒从导管注射到子宫肌瘤动脉中,从而阻断其血液供应并且使其最终萎缩和死亡。虽然该过程造成的创伤比子宫切除术小,但是其经常导致与疼痛有关的术后并发症。此外,培训成执行子宫动脉栓塞术的医生通常是介入放射科医生,与特别地培训成处理妇科问题的医生不同,然而特别地培训成处理妇科问题的医生通常不具有执行基于导管的子宫动脉栓塞术的技术。
子宫镜切除术通常涉及将子宫镜(即,成像显示器)通过阴道——即,经子宫颈地插入到子宫中,接着利用通过子宫镜传送至子宫肌瘤的装置将子宫肌瘤从子宫切掉。子宫镜切除术通常落入两种类型中的一种。在一种类型中,以环形切割线为形式的电烙装置固定地安装在子宫镜的远端端部上,子宫镜和电烙装置的组合被称为电切镜。电流利用电切镜至子宫的传输通常是单极的,并且通过施加于病人的皮肤的传导垫由至用于装置的电源部件的传导路径完成回路。以此方式,通过使环与参与的子宫壁的部分接触来移除组织。例如在1999年5月25日公布的、发明人为Thompson的美国专利No.5,906,615中公开了这种装置的示例。
在另一种子宫镜切除术中,机电切割器通过子宫镜中的工作通道插入。接着,通过使切割器与参与的子宫壁的部分接触来移除组织,该切割器通常具有转动的切割仪器。例如在2007年6月5日公布的、发明人为Cesarini等人的美国专利No.7,226,459;2000年3月7日公布的、发明人为Savage等人的美国专利No.6,032,673;1998年3月24日公布的、发明人为Alden等人的美国专利No.5,730,752;2006年3月2日公开的、发明人为Shener等人的美国专利申请公开No.US2006/0047185A1以及1999年3月11日公开的PCT国际公布No.WO99/11184中公开了机电切割器种类的子宫镜切除术的示例,所有这些专利申请及专利被结合在此,作为参考。
在上述种类的子宫镜切除术两者中,在子宫肌瘤移除之前,子宫通常膨胀以在子宫内产生工作空间。(因为子宫是松弛器官,所以这样一种工作空间通常不会自然地存在于子宫中。同样,子宫的壁在处于放松状态时通常相互接触。)用于在子宫内产生这样一种工作空间的传统技术是在足够的压力下通过子宫镜将流体施加于子宫以使子宫膨胀。传统地用于使子宫膨胀的流体的示例包括如二氧化碳的气体或更常见地,如水或某些水溶液(例如,盐溶液或基于糖的水溶液)的液体。在利用电切镜实现切除的部位处,通常必须的是,膨胀流体不导电以使电不传导至不期望的位置。然而,因为在压力(该压力可以大到100mmHg或更大)下施加膨胀流体,所以尤其在切割组织时,存在膨胀流体可以被子宫中的血管吸收,即,进入血管内渗的风险,对病人而言,该吸收可能是非常有害的。因为过度内渗可导致死亡,所以通常利用测量系统在连续的基础上监控流体吸收。
然而,尽管存在前述的进入血管内渗的风险,但是利用对流体吸收的适当监控,子宫镜切除术是用于移除子宫肌瘤的高效且安全的技术。但是,子宫镜切除术的一个缺点是其通常要求对病人施加麻醉。这是因为传统的电切镜通常具有超过7mm的直径并且因为机械切割器类型的装置通过其插入类型的传统子宫镜通常具有大约9mm的直径。相比之下,在不造成病人明显不适的情况下,子宫颈通常不能扩大至大于大约5.5mm的直径。结果,由于对麻醉的需要,子宫镜切除术通常在医院手术室中执行,并且因此承担由所需的环境和支持人员而产生的较大成本。
发明内容
本发明提供用于组织移除的新颖性方法、系统以及装置。如上所述的方法、系统以及装置可用于例如移除子宫肌瘤和其它的异常妇科组织。
根据本发明的一个方面,提供一种组织移除装置,组织移除装置包括(a)外壳;(b)外管,外管固定于外壳并且从外壳向远端延伸,外管包括切除窗口;(c)内管,该内管布置在外管内,内管能够相对于外管滑动和转动,内管包括远端端部;以及(d)驱动机构,该驱动机构用于使内管相对于外管转动并且同时用于使内管相对于外管平移地摆动,以使内管的远端端部在来回移动通过切除窗口的同时转动,其中,驱动机构包括成形为包含双螺旋凹槽的驱动轴,驱动轴可以在平移中静止。
根据本发明的一个方面提供一种组织移除装置。装置包括具有近端端部、远端端部以及侧向开口的细长的外管状本体。细长的内管设置在外管内,并且能够移动以打开和关闭侧向窗口。至少一个组织切削刃设置在内管上,用于切断延伸到窗口内的组织。切削刃可以形成在切割尖端上,该切割尖端被焊接、硬焊、软焊到或以其它方式附接于内管的远端端部。切削刃具有超过内管的材料的硬度的硬度。
组织移除装置可以构造成使得以至少大约1.8克/分钟的速率移除通过切削刃切断的组织,并且外管状本体具有不大于大约3.5mm的外径。切削刃可以具有至少大约50的洛氏C硬度,而内管具有不大于大约40的洛氏C硬度。
在一个实施方式中,切削刃通过铣削步骤形成,并且内管通过拉伸步骤形成。装置可进一步包括在内管和外管之间的涂层。涂层可以位于内管的外表面上,并且可以包括氮化钛合金。涂层可以包括至少大约50的洛氏C硬度,在一些实施方式中至少大约60的洛氏C硬度以及最优地至少大约70的洛氏C硬度。
本发明的另外的方面、特征以及优点将在下列描述中被部分地阐述。实施方式将被描述得足够详细以使得本领域技术人员能够实践本发明,并且可以理解,在不脱离本发明的范围的情况下,可以使用其它的实施方式,并且可以进行结构或过程的改变。因此,无限定意义地进行下述详细说明,并且本发明的范围由所附权利要求最佳地限定。
附图说明
在此并入到本说明书中并且构成本说明书的一部分的附图示意出本发明的各种实施方式并且,其与描述一起起到说明本发明的原理的作用。在附图中,类似的附图标记表示类似的部件:
图1是根据本发明的教导构造的组织移除系统的第一实施方式的部分分解立体图;
图2(a)至2(d)是图1中示出的组织移除装置的各种视图,组织移除装置在图2(a)至2(c)中示出为与真空管的远端端部和外部驱动轴在一起;
图3是图1中示出的导引装置的立体图;
图4(a)和4(b)是图1中示出的导引装置的分解立体图;
图5是图1中示出的导引装置的右立体图,其中,外壳的右半体被移除;
图6是图1中示出的导引装置的纵向截面图;
图7是以截面图示出的图1中示出的导引装置的放大局部立体图,其中,仅示出歧管、溢放口以及护套;
图8是图1中示出的导引装置的多腔护套的放大远端端视图;
图9是图1中示出的导引装置的仪器引导组件的局部放大视图;
图10(a)和10(b)是可以在图1中示出的组织移除装置中使用的替代性内管状部件的局部纵向截面图;
图11是可以在图1中示出的组织移除装置中使用的替代性指示器套筒的侧视图;
图12是以部分截面图示出可以在图1中示出的组织移除系统中使用的组织移除装置和导引器的替代性组合的局部侧视图;
图13(a)和13(b)是以部分截面图示出可以在图1中示出的组织移除系统中使用的组织移除装置和导引器的又一替代性组合的局部侧视图;
图14是以部分截面图示出可以在图1的组织移除系统中使用的替代性组织移除装置的局部侧视图;
图15(a)和15(b)分别是可以在图1的组织移除系统中使用的另一替代性组织移除装置的局部立体图和局部部分分解立体图;
图16是可以在图1的组织移除系统中使用的另一替代性组织移除装置的局部侧视图;
图17是可以在图1的组织移除系统中使用的另一替代性组织移除装置的局部侧视图;
图18是可以在图1的组织移除系统中使用的另一替代性组织移除装置的局部立体图;
图19是可以在图1的组织移除系统中使用的另一替代性组织移除装置的局部立体图;
图20是可以在图1的组织移除系统中使用的另一替代性组织移除装置的局部立体图;
图21是可以在图1的组织移除系统中使用的另一替代性组织移除装置的局部立体图;
图22(a)至22(e)是可以在图1的组织移除系统中使用的另一替代性组织移除装置的各种视图(在图22(c)至22(e)中未示出真空外壳以显示安置在其内的构件);
图23是插入到图1中示出的导引器中的本发明的闭塞器的局部截面图;
图24是根据本发明构造的闭塞器和导引器的替代性组合的侧视图;
图25(a)和25(b)分别是根据本发明构造的闭塞器和导引器的另一组合的未装配侧视图和装配截面图;
图26(a)至26(c)是图1中示出的导引装置的另一替代性导引装置的局部立体图,其中,替代性导引装置在图26(b)和26(c)中示出为处于部分分解状态;
图27是根据本发明的教导构造的组织移除系统的第二实施方式的立体图;
图28(a)至28(d)分别是图27中示出的切碎器组件的仰视分解立体图、俯视分解立体图、仰视部分分解图以及以截面图示出的局部侧视图;
图29(a)和29(b)分别是图27中示出的驱动组件的部分分解俯视立体图和部分分解仰视立体图;
图30是可以在图27的组织移除系统中使用的替代性组织移除装置的局部部分分解立体图;
图31(a)和31(b)是可以在图27的组织移除系统中使用的另一替代性组织移除装置的局部部分分解立体图;
图32是可以在图27的组织移除系统中使用的另一替代性组织移除装置的局部部分分解立体图;
图33是可以在图27的组织移除系统中使用的另一替代性组织移除装置的局部部分分解立体图;
图34是可以在图27的组织移除系统中使用的另一替代性组织移除装置的局部截面图;以及
图35是可以在图27的组织移除系统中使用的另一替代性组织移除装置的局部截面图。
具体实施方式
下面将主要在优化用于执行诸如子宫肌瘤或其它异常子宫组织移除之类的一或更多个治疗或者诊断妇科或泌尿过程的装置和过程方面描述本发明。然而,本发明的装置和相关过程可以通过各种进入途径在整个身体的各项应用中使用。
例如,本发明的装置可以经由开放式手术、诸如腹腔镜进入之类的微创式进入或诸如经由经过皮肤进入之类的极微创过程优化使用。另外,本发明的装置可以构造用于经由身体的自然开口中的任何一个进入治疗或诊断部位以完成经由耳朵、鼻子、嘴和经由经直肠途径、尿道途径以及阴道途径的进入。
除了本文中详细描述的一个或更多个妇科和泌尿过程的执行之外,本发明的系统、方法、设备以及装置可用于执行一个或更多个附加过程,该一个或多个附加过程包括但不限于,进入诸如膀胱、胸部、肺、胃、肠、食道、口腔、直肠、鼻窦、耳咽管、心脏、胆囊、脊椎、肩、膝盖、臀部、脑、动脉、静脉以及各种管之类的各种器官和组织中的任何一个以及从上述中的任何一个的组织操作或移除。进入的通径包括但不限于,经子宫颈通路、经阴道壁路径、经子宫路径、经泡囊路径、经尿道路径以及其它的路径。
现在参照图1,示出组织移除系统的一个实施方式的部分分解立体图,组织移除系统根据本发明的教导构造并且总体上以附图标记5表示。
系统5特别适合于移除子宫肌瘤和其它的异常妇科组织。然而,应当理解,系统5不限于这种应用并且可以在对本领域技术人员而言显而易见的其它的解剖中使用。
系统5可以包括组织移除装置(或切碎器)6、导引装置7、柔性子宫镜8、流体供应件9、真空组件10以及马达驱动组件11。
现在参照图2(a)至2(d),可以更详细地看到组织移除装置6。装置6可以包括分别互补的左外壳半体13-1和右外壳半体13-2,互补的左外壳半体13-1和右外壳半体13-2中的每一个均可以由刚性聚合物或其它合适的材料制成。半体13-1和13-2可以例如利用螺钉15结合在一起以形成包括圆形侧壁16、开放近端端部17以及开放远端端部19的细长中空外壳13。外壳13可以弯曲或以其它符合人体工学地成形用于舒适地配合在使用者的手中。近端盖18可以安装在近端端部17中,盖18可以成形为包括一对内腔18-1和18-2。内腔18-1可用于容纳例如外部驱动轴,并且内腔18-2可用于容纳例如真空管。远端盖20可安装在远端端部19中,盖20成形为包括可以用于容纳例如一对同轴切割管的内腔。
多个肋14可以沿着半体13-1和13-2的相应内表面整体地形成并适当地安置,肋14为外壳13提供结构加强并且用于使安置在外壳13内的机械构件中的某些对齐。
装置6还可包括适于绕着其纵向轴线转动的内部驱动轴21。轴21可以成形为包括近端端部23和远端端部25,轴21可以为由合适的刚性金属或聚合物制成的细长整体形结构。轴21的近端端部23可以同轴地安装在外部驱动轴29的远端端部27上并且固定于外部驱动轴29的远端端部27,外部驱动轴29插入穿过安装在外壳13中的保持器28。以此方式,轴21的转动可以机械地联接于轴29的转动。轴21的远端端部25可以插入穿过环形衬套31中的开口30,衬套31可以经由设置在衬套31中的周向狭槽32匹配地安装在肋14-1上。
装置6可进一步包括适合于绕着其纵向轴线转动的平移驱动轴35。轴35可以成形为包括近端端部37、中间部39以及远端端部41,轴35可以为由合适的刚性金属或聚合物制成的细长整体形结构。轴35的近端端部37可以同轴地安装在内部驱动轴21的远端端部25上并且固定于内部驱动轴21的远端端部25。以此方式,轴35的转动可以机械地联接于轴21的转动。中间部39可以成形为包括双螺旋部,该双螺旋部包含右旋螺纹螺旋通道42和左旋螺纹螺旋通道43。螺旋通道42和43可以具有相同或不同的螺距,但是优选地具有相同的螺距。螺旋通道42和43可以在它们各自的端部处平滑地混合在一起以形成连续凹槽,使得可以存在从一个螺旋通道到另一个螺旋通道的平稳过渡。轴35的远端端部41的尺寸可以适当地设计成容纳在环形衬套45中的开口44内,衬套45可以经由设置在衬套45中的周向狭槽46匹配地安装在肋14-2上。应当注意,虽然轴35适合于转动,但是轴35可以在平移中静止。
装置6还可以包括适合于绕着其纵向轴线转动的齿轮组件50。齿轮组件50可以成形为包括近端直齿轮51和远端管部52,齿轮组件50可以为由合适的刚性金属或聚合物制成的细长整体形结构。齿轮组件50可以在双螺旋部和远端端部41之间的区域中同轴地安装在轴35的中间部39上,并且齿轮组件50可以利用径向地插入穿过管部52并且进入设置在轴35中的开口内的销固定于轴35。以此方式,直齿轮51的转动可以机械地联接于轴35的转动。
装置6可进一步包括摆动平移组件61。平移组件61又可包括支架62和通道接合部件63。支架62可以成形为包括近端部64、中间部65以及远端部66,支架62可以为由合适的刚性金属或聚合物制成的整体形结构。近端部64和远端部66的顶部可以延伸超过中间部65的顶部并且可以成形为分别包括环67-1和67-2,环67-1和67-2相互对齐。纵向孔68-1可以设置在支架62的底部附近,孔68-1的尺寸可以适当地设计成同轴地容纳轴35的中间部39,同时允许中间部39在其内自由地转动。通道接合部件63可以成形为包括基部69和棘爪70,通道接合部件63可以为由合适的刚性金属或聚合物制成的整体形结构。基部69可以布置在开口68-2中,开口68-2可以从中间部65的顶部向下延伸成与孔68-1连通,其中,棘爪70在轴35的双螺旋部内行进。以此方式,当轴35转动时,棘爪70可以连续地来回行进通过轴35的双螺旋部,从而使支架62平移地摆动。如可以理解的,支架62平移地摆动的速度可例如通过使轴35的双螺旋部的平移长度、通道42和43的角度、轴29的转动速度等变化来改变。如将在下面进一步讨论的,理想的是使装置6运行以使得支架62以大约2.8周期/秒平移地摆动。
装置6可进一步包括适合于绕着其纵向轴线转动的轴72。轴72可以成形为包括近端部72-1和远端部72-2,轴72可以为由合适的刚性金属或聚合物制成的细长整体形管状结构。近端部72-1可以插入穿过支架62的环67-1和67-2并且可以相对于环67-1和67-2自由地转动。远端部72-2可以是细长直齿轮形式。远端部72-2可以与齿轮组件50的直齿轮51啮合以使直齿轮51的转动引起轴72的转动。远端部72-2可以是细长的使得即使当远端部72-2相对于直齿轮51平移地移动时,其可以保持与直齿轮51的啮合。取决于例如两个齿轮上的相对直径(两个齿轮的转动速度的比与两个齿轮的直径的比成反比),远端部72-2转动的速度(以及因此轴72转动的速度)可以与直齿轮51转动的速度相同或不同。因此,通过适当地设计直齿轮51和远端部72-2的尺寸,可以实现期望的转动速度,即使在外部驱动轴的转动速度固定的情况下。例如,在示出的实施方式中,远端部72-2具有为直齿轮51的直径的四分之一的直径,并且因此以四倍的齿轮51的速度转动。因此,如果外部驱动轴具有大约1500rpm的转动速度,则齿轮51将以1500rpm转动并且远端部72-2将以6000rpm转动。如可以理解的,远端部72-2的转动速度不取决于平移组件61的与轴35的双螺旋部的相互作用;因此,远端部72-2可以基于期望平移速度的要求获得比可能的转动速度更高或更低的转动速度。尽管存在上述情况,但是轴72平移地联接于支架62。因此,当支架62平移地摆动时,轴72也如此。
装置6还可以包括溢放口部件74,溢放口部件74可以为由刚性聚合物或金属制成的整体形管状结构。溢放口部件74的近端端部可以固定地安装在保持器75中,保持器75可以安装在外壳13的远端端部处,其中,溢放口74的远端端部从外壳13向远端延伸一短距离,诸如,例如,大约2英寸。
装置6还可以包括切割机构。在本实施方式中,切割机构可以包括外管状部件76和内管状部件77,内管状部件77转动地移动,并且同时以将在下面进一步描述的方式相对于外管状部件76平移地摆动。外管状部件76可以成形为包括开放近端端部、封闭远端端部81以及内腔82,内腔82从开放近端端部79延伸至刚好在封闭远端端部81之前的点,外管状部件76可以是由不锈钢或另一类似的合适的材料制成的整体形结构。部件76可以同轴地安装在溢放口部件74内,其中,部件76的近端端部布置在溢放口部件74的近端端部内,并且其中,部件76的远端端部81向远离延伸超过溢放口部件74的远端端部延长的距离,诸如,例如5英寸。部件76的近端端部可以固定在保持器75内。
外管状部件76还可以成形为包括切除窗口89,组织可以被捕捉并吸入到切除窗口89内,窗口89定位成靠近远端端部81,诸如例如,距该远端端部0.25英寸。窗口89可以成形为包括近端端部89-1和远端端部89-2。近端端部89-1可以向近端逐渐倾斜,并且远端端部89-2可以向远端逐渐倾斜。更具体地,窗口89可以具有大约0.55英寸的长度,近端端部89-1可以为具有例如0.085英寸的曲率半径的径向端部,并且远端端部89-2可以为具有例如0.150英寸的曲率半径的径向端部。窗口89可以在管状部件76的圆周的大部分上延伸,诸如,例如,圆周的大约60%。
外管状部件76可以具有小于大约5.5mm的外径。然而,为了使伤害病人的风险降低和为了避免对病人施加麻醉的需要,外管状部件76优选地具有小于大约5mm的外径、更优选为小于4mm的外径、甚至更优选为小于3mm的外径以及又甚至更优选为小于2mm的外径。然而,如果装置6使用在手术室环境中,其中,可用全身麻醉,外管状部件76的直径可以增大以使组织移除最大化。在此情况下,外管状部件76可以具有通常小于约12mm的直径、优选为小于大约11mm的直径以及对于某些应用,小于10mm的直径。取决于特定的临床应用,外管状部件76可以构造成具有不大于大约9mm的外径、在一些应用中小于大约8mm的外径、优选为小于7mm的外径以及更优选为小于6mm的外径,其中,OD期望地最小化。
内管状部件77可以成形为包括近端端部91、远端端部92以及纵向内腔93,内管状部件77可以为由不锈钢或另一类似合适的材料制成的细长整体形结构。远端端部92可以成形为包括外部斜面,诸如,例如大约20度的外部斜面。管状部件77的中间长度可以同轴地容纳在轴72内并且可以固定联接于轴72以便与其一起平移运动和转动运动。管状部件77的近端端部91可以可滑动地安装在真空管连接器95内,真空管连接器95又可以联接于插入穿过盖18的内腔18-2的真空管393。O形环96可以安装在连接器95内以保持与管状部件77的良好密封。安装在外壳13内的环形衬套98可用于容纳管状部件77并且保持其对齐。
管状部件76和77可以布置成使得在管状部件77处于完全缩回(即,近端)位置时,管状部件77的远端端部92可以充分地撤回以允许组织进入窗口89(优选地,其中,管状部件的远端端部92安置成靠近窗口89),并且在管状部件77处于完全前进(即,远端)位置时,管状部件77的远端端部92可以向远端安置在窗口89的远端端部89-2处。以此方式,当管状部件77平移且转动地移动经过窗口89时,可以剪切窗口89内的组织。为了促进组织的这种剪切,内管状部件77的外径可以仅比外管状部件76的内径略小(例如,大约0.002英寸)。
已经证明,由转动的内管77和外管76的接触产生的热能可以导致咬接,其中,两个管状部件熔合在一起。为了减轻该咬接风险,内管77的外表面已经覆盖有低摩擦且低磨损的涂层(即,氮化钛)。可替代地,涂层可以由外管76的内表面承载。涂层可以具有至少大约50的洛氏C硬度、优选为,至少大约60的洛氏C硬度以及在一些装置中,至少大约70的洛氏C硬度。
装置6还可以包括指示器套筒98。套筒98可以同轴地安装在溢放口部件74上并且固定地安装于溢放口部件74,套筒98可以为由与溢放口部件74在视觉上容易区分开的材料制成的细长管状部件,其中,套筒98的近端端部98-1靠着外壳13的远端端部齐平定位。材料的适合于用作套筒98的示例可以为白色或彩色长度的收缩性包裹材料。套筒98的尺寸可以设计成使得在装置6插入到导引装置7内时,使用者能够看见套筒98的远端端部98-2直到装置6的远端端部81前进超过导引器7的远端端部。换言之,远端端部98-2可以用于指示装置6的远端端部81何时与导引器7的远端端部齐平定位。以此方式,使用者可以安全地控制装置6的远端端部的位置,并且因此在将装置6插入到病人体内时,使其保持在导引器7内,从而使在装置6的引入期间的裂伤和穿孔的风险降低。
现在参照图3至7,导引器7可以包括外壳121。外壳121又可包括左手柄半体123和右手柄半体125。左手柄半体123和右手柄半体125可以通过多个螺钉127连结,左手柄半体123和右手柄半体125可以由刚性聚合物或其它合适的材料模制或以其它方式制造。左手柄半体123和右手柄半体125可以利用合适的粘合剂、压销连结或者可以利用超声波或其它的方式焊接在一起,而不是通过螺钉127连结。左手柄半体123和右手柄半体125共同地限定包括手柄部129和筒部131的中空枪形结构。手柄部129可以成形为包括设置在其底部端部134处的开口133和沿着接近底部端部134的其远端面136设置的开口135。狭槽133-1可以设置在右手柄半体125中,狭槽133-1从开口133朝向筒部131延伸一短距离。筒部131可以成形为包括设置在其近端端部138处的开口137和设置在其远端端部140处的开口139。另外,筒部131可以成形为包括在近端端部138和远端端部140的中间位置处设置在右手柄半体125中的横向开口141。
左手柄半体123和右手柄半体125的内表面可以成形为包括互补成组的肋(未示出)。该肋可以为左手柄半体123和右手柄半体125提供结构加强并且可以有助于保持安置在外壳121内构件的正确安置和对齐。
导引器7可进一步包括歧管145。歧管145可以是成形为包括主要管状部件147和侧向管状部件149的整体形分支结构,歧管145可以由刚性聚合物或其它合适的材料模制或以其它方式制造。主要部件147可以包括近端端部151、开放远端端部153、侧壁155以及纵向内腔157。主要部件147的近端端部151可以成形为包括相对较大直径的顶部开口159和相对较小直径的底部开口161。侧向部件149可以包括开放近端端部163、开放远端端部165、侧壁167以及纵向内腔169。侧壁149的内腔169可以通过开放远端端部165与主要部件147的内腔157流体连通。
歧管145可以利用一对销171和173联接于外壳121,该对销171和173可以从侧壁155延伸并且可以分别容纳在分别设置在左手柄半体123和右手柄半体125的内面上的中空凸台175内。在歧管145因此联接于外壳121的情况下,歧管145的近端端部151可以安置在筒部131中,其中,侧壁155紧密地配合在开口139内,并且其中,歧管145的远端端部153向远端延伸超过远端端部140一短距离。
导引器7可进一步包括溢放口部件181。溢放口部件181可以是成形为包括开放近端端部183、开放远端端部185、侧壁187以及纵向内腔189的整体形分支结构,溢放口部件181可以由刚性聚合物或其它合适的材料模制或以其它方式制造。溢放口部件181可以部分地插入到歧管145的内腔157内,并且可以紧密地配合在内腔157内且利用合适的粘合剂等固定地紧固于内腔157,其中,溢放口部件181的近端端部183安置成刚好在侧向部件149的开放远端端部165远端,并且其中,溢放口部件181的远端端部185向远端延伸超过主要部件147的远端端部153一短距离。
导引器7可进一步包括护套191,在图8中也分开地示出护套191。护套191可以是成形为包括近端端部192、远端端部193以及侧壁194的刚性整体形结构,护套191可以由诸如尼龙12之类的合适的聚合物挤压或以其它方式制造。护套191可进一步成形为包括具有固定形状和大小的多个纵向内腔,该内腔包括顶部内腔196、底部内腔197以及一对侧向内腔198-1和198-2。如将在下面进一步讨论的,顶部内腔196可以用作仪器内腔,底部内腔197可以用作可视化内腔,并且侧向内腔198-1和198-2可以用作流入流体供应内腔。(开口(未示出)可以设置在靠近远端端部193的侧壁194中,该侧向开口与侧向内腔198-1和198-2流体连通,例如,以分配通过侧向内腔198-1和198-2向远端引导的流入流体供应中的一些。)护套191的近端端部192可以部分地插入到溢放口部件181的内腔189内,并且可以紧密地配合在内腔189内且利用合适的粘合剂等固定地紧固于内腔189,其中,护套191的近端端部192与溢放口部件181的近端端部183齐平,并且其中,护套191的远端端部193向远端延伸超过溢放口部件181的远端端部185几英寸。
护套191的尺寸可以设计成具有大约5.5mm的外径,护套191优选为将被插入到病人体内的导引器7的唯一构件,其中,内腔196具有大约3mm的直径,内腔197具有大约2mm的直径,并且内腔198-1和198-2每个都具有大约1.33mm的直径。可以进一步声明,外径与工作通道的比为导引器效率的示例性度量。可以看出,最佳比将为大约1.0、优选为不大于约2.0以及更优选为不大于约1.9。在此处设置的情况下,这些直径的比为约1.83,而预计系统具有2.25的比。通过因此设计护套191的尺寸,如果护套191插入穿过病人的子宫颈,则伤害病人的风险和对向病人施行麻醉的需要可以最小化。然而,应当理解,用于护套191的上述尺寸仅是示例性的并且可以取决于如何使用导引器7而变化。
导引器7可进一步包括安装在外壳121内以用于提供与内腔196对齐的连续通道的仪器引导组件,组织移除装置6可以插入到该仪器引导组件内。仪器引导组件可以包括引导本体201。本体201可以是成形为包括近端部203、远端部205以及中间部207的整体形管状结构,本体201可以由刚性聚合物或其它合适的材料模制或以其它方式制造。中间部207可以相对于近端部203和远端部205在内径和外径方面减小,以使环形座208在中间部207和远端部205的接合点处形成在本体201内。本体201的内表面可以从近端部203到中间部207向内逐渐缩小以便于装置6的到中间部207内的插入并且限制装置6可以插入到本体201内的程度。
本体201可以紧密地配合在外壳121的开口137内并且利用合适的粘合剂等固定地紧固于外壳121的开口137,其中,本体201的远端部205和中间部207安置在外壳121的筒部131内,并且其中,本体201的近端部203延伸穿过开口137并且向近端继续延伸超过外壳121的近端端部138一短距离。
仪器引导组件还可以包括套筒211。套筒211可以是成形为包括主要管状部件213和侧向管状部件215的整体形分支结构,套筒211可以由刚性聚合物或其它合适的材料模制或以其它方式制造。主要部件213可以包括开放近端端部216、开放远端端部217以及纵向内腔219。主要部件213的近端端部216可以成形为紧密地配合在本体201的远端部205内并且可以利用合适的粘合剂等粘结于本体201的远端部205。侧向部件215可以包括开放近端端部220、开放远端端部221以及纵向内腔223。侧向部件215的内腔223可以通过开放近端端部220与主要部件213的内腔219流体连通。侧向部件215的远端端部221可以延伸穿过设置在外壳121的右手柄半体125中的开口141并且可以联接于阀228。阀228可以为诸如旋塞阀之类的主动控制阀或诸如弹簧致动球阀之类的被动控制阀。阀228可以在其输出端部处连接于一定长度的管子(未示出)以及流体容器(未示出),以用于例如在装置6不存在于导引器7内时,引导以及收集例如穿过阀228的流出流体。
仪器引导组件可进一步包括密封垫231和阀233的组合。密封垫231和阀233可以为固定地安置在本体201的座208和套筒211的近端端部216之间的弹性部件(见图9)。密封垫231可以包括中央开口235,密封垫231可以相对于阀233在近端定位。开口235的尺寸可以适当地设计成使得在装置6插入穿过开口235时,流体不能容易地在近端穿过在装置6的外侧周围的密封垫231。阀233可以设计成使得在装置6不插入穿过阀233时,流体不能容易地在近端穿过阀233,阀233可以成形为包括圆顶,该圆顶在其顶部处具有交叉缝。
仪器引导组件可进一步包括管241。管241可以包括近端端部243和远端端部245,管241可以为由不锈钢等制成的刚性海波管(hypotube)。近端端部243可以利用合适的粘合剂等固定地安装在套筒211的内腔219内。管241的远端端部245可以紧密地配合在护套191的内腔196内并且可以利用合适的粘合剂等固定在护套191的内腔196内。
导引器7可进一步包括安装在外壳121内以用于提供与内腔197对齐的连续通道的可视化引导组件,子宫镜8可以插入到该显像引导组件内。可视化引导组件可包括引导本体251。本体251可以是成形为包括相对较大直径的近端部253、相对较小直径的远端部255以及从近端部253到远端部255在直径方面逐渐缩小的中间部257的整体形管状结构,本体251可以由刚性聚合物或其它合适的材料模制或以其它方式制造。本体251可以布置在外壳121的手柄部129内,其中,近端部253与开口133向内隔开一短距离,并且其中,远端部255面向筒部131。近端部253可以紧密地配合在外壳121的左手柄半体123和右手柄半体125之间并且利用粘合剂或其它合适的器件固定地装配在外壳121的左手柄半体123和右手柄半体125。如将在下面进一步讨论的,近端部253的尺寸可以适当地设计成容纳子宫镜8的近端部,其中,本体251的中间部257的尺寸适当地设计成起到限制子宫镜8可以插入到本体251内的程度的止动件的作用。环形座258可以设置在远端部255内并且可以相对于远端部255的远端端部259在近端隔开。
可视化引导组件可进一步包括引导连接器261。引导连接器261可以是成形为包括相对较大直径的近端部263、相对较小直径的远端部265以及从近端部263到远端部265在直径方面逐渐缩小的中间部267的整体形管状结构,引导连接器261可以由刚性聚合物或其它合适的材料模制或以其它方式制造。近端部263可以成形为紧密地配合在本体251的远端部255内并且可以利用合适的粘合剂粘结于本体251的远端部255。
可视化引导组件可进一步包括密封垫271和阀273的组合。密封垫271和阀273可以为固定地安置在本体251的座258和连接器261的近端部263之间的弹性部件。密封垫271可以包括中央开口,密封垫271可以相对于阀273在近端定位,该中央开口的尺寸适当地设计成使得在子宫镜8插入穿过该中央开口时,流体不能容易地在近端穿过子宫镜8的外侧周围的密封垫271。阀273可以设计成使得在子宫镜8不插入穿过阀273时,流体不能容易地在近端穿过阀273,阀273可以成形为包括圆顶,该圆顶在其顶部处具有交叉缝。
可视化引导组件可进一步包括管281。管281可以包括近端端部283、远端端部285以及内腔286,管281可以是由合适的聚合物或其它材料制造的柔性整体形部件。近端端部283可以利用合适的粘合剂等固定地安装在连接器261的远端部265内。管281的远端端部285可以紧密地配合在护套191的内腔197内并且可以利用合适的粘合剂等固定在护套191的内腔197内。内腔286的尺寸可以适当地设计成使得子宫镜8的远端部可以插入到内腔286内并且以此方式被管281引导至内腔197。
导引器7可进一步包括用于将子宫镜8可逆地联接于可视化引导组件的机构。该机构可以包括凸轮锁定件291。锁定件291可以是成形为包括杠杆292和支轴293的整体形结构,锁定件291可以由刚性聚合物或其它合适的材料制造。支轴293可以利用枢销294可枢转地安装在外壳121上,枢销294插入穿过支轴293中的横向开口295,并且在其相反端部处固定地接收在分别设置在左手柄半体123和右手柄半体125中的开口296和297中。支轴293可以包括适合于在杠杆292朝向手柄部129枢转时摩擦地接合子宫镜8的近端部的面298。
导引器7可进一步包括管301。管301可以是成形为包括近端端部303和远端端部305的柔性整体形结构,管301可以由合适的聚合物或其它的材料制造。近端端部303可以紧固于固定地安装在外壳121的开口135内的路厄式配件(lurefitting)307的远端端部。远端端部305可以安置在歧管145的内腔169内并且可以利用粘合剂或其它合适的器件固定在适当的位置。如将在下面进一步讨论的,路厄式配件307可以连接于流体供应件9的输出端。以此方式,通过配件307分配并且进入管301的流体可以通过管301引导至歧管145。此后,歧管145中的流体可以在远端流动穿过护套191的内腔198-1和198-2。
现在返回参照图1,子宫镜8可以包括近端部311和远端部313,子宫镜8可以为例如,传统的柔性子宫镜。近端部311可以包括输入端口315、输出端口317以及远端端部318,近端部311可以为相对刚性、在长度方面紧凑以及在直径方面较宽。远端部313可以包括远端端部319,远端部313可以为相对柔性、在长度方面细长以及在直径方面较窄。子宫镜8的尺寸可以适当地设计成使得近端部311的远端端部318可以容纳在本体251中,其中,远端部313向远端延伸穿过密封垫271、阀273、连接器261、管281以及内腔197,并且其中,远端端部319安置在护套191的远端端部193处或超过护套191的远端端部193一短距离。虽然在示出的实施方式中未呈现,但是子宫镜8的近端部311可以设有可用于与凸轮锁定件291紧密配合或以其它方式接合凸轮锁定件291的凹口或其它的物理特征。子宫镜8的远端端部319可以构造成允许观察诸如处于相对于远端部313的纵向轴线在0度角、15度角或30度角的物体。以此方式,通过将子宫镜8放置在特定角度方位,子宫镜8可以用于观察装置6的远端端部的操作。可以通过使子宫镜8定向成使得输入端口315与狭槽133-1对齐并且延伸穿过狭槽133-1来确保这一角度定位。
流体供应件9可以包括含流体的注射器、蠕动泵或具有可联接于路厄式配件307的输出端部321的另一合适的流体分配装置。流体供应件9可以包括用于以期望的速率分配来自其的流入流体的自动化装置(未示出)。
真空组件10可以包括标本收集容器391和真空源392。抽空管393的远端端部可以连接于真空管连接器95的近端端部,并且抽空管393的近端端部可以联接于容器391的第一端口394。管395的远端端部可以联接于容器391的第二端口396,并且管395的近端端部可以联接于真空源392。以此方式,真空源392可用于将抽吸施加于装置6,并且任何抽出的组织、液体或抽吸通过装置6的类似物质可以收集在容器391中。
马达驱动组件11可以包括外壳397,马达驱动组件11可以利用电源线(未示出)联接于诸如AC壁装电源插座之类的电源,其中,可以布置有电子设备(未示出)和马达(未示出)。脚踏板398可以通过电缆398-1联接于马达驱动组件并且可以用作使马达选择性地致动或停止的电源开关。轴29的近端端部可以机械地联接于马达以便旋转,并且轴29的远端端部可以以上述讨论的方式插入穿过安装块18中的开口18-1并且联接于内部轴21。保护护套399可以覆盖轴29的大部分长度。马达驱动组件11可进一步包括真空传感器400,使得可以监测容器391内的压力,真空传感器400可以通过管401联接于容器391。以此方式,真空压力的突然增大可以表示堵塞已经发生。堵塞的出现可以经由定位在外壳397上的警报器(未示出)来表示。堵塞的检测通常清楚地表示装置6的进一步操作仅可以使堵塞情况恶化,并且可能必须停止组织移除。马达驱动组件11可以构造成使马达的致动与真空源392的致动同步。以此方式,打开马达将同时打开真空源392。相应地,无论马达什么时候关闭,真空源392都可不起作用。
在使用时,子宫镜8的远端端部319可以首先插入穿过导引器7的可视化引导通道,然后穿过歧管145,并且接着穿过护套191的内腔197。在子宫镜8因此插入导引器7内的情况下,凸轮锁定件291可以用于将子宫镜8的近端部311固定于导引器7。接着,子宫镜8的输入端部315和输出端部317可以分别联接于光源和照相机。可替代地,照相机可以被省略,并且可以用肉眼直接观察输出端部317。接着,流体供应件9可以联接于导引器7的路厄式配件307。护套191的远端端部193可以经子宫颈地,即,穿过阴道和子宫颈,插入到病人的子宫内。在将护套191的远端端部193引入到病人体内之前,子宫颈可以利用直径增大的闭塞器以传统方式逐渐地扩大。接着,可以通过将流体从流体供应件9分配到导引器7内来冲洗子宫中可能存在的血液和其它残余物,接着,该流体可以通过内腔198-1和198-2在远端离开导引器7。阀228可以在该冲洗过程中打开以使在子宫中存在的流体和任何残余物可以通过护套191的内腔196在近端离开子宫,并且此后,可以通过在近端经过管241,进入套筒211的主要部件213内,穿过套筒211的侧向部件215并且穿过阀228离开导引器7。当冲洗过程完成时,阀228可以在流体可继续通过内腔198-1和198-2分配到子宫中时关闭,从而使子宫变得通过流体膨胀。当通过该流体使子宫充分地膨胀时,阀228可以在流体可继续分配到子宫中时打开。以此方式,子宫可以在流体连续地循环通过子宫时保持期望程度的膨胀。在子宫因此利用流体膨胀的情况下,子宫镜8可以用于检查子宫的内部。
如果检测到希望移除的异常部位,则组织移除装置6可以,即,通过将外管状部件76和内管状部件77的远端端部在远端插入穿过导引器7的仪器引导通道并且接着穿过护套191的通道196来装载到导引器7内,其中,外壳13保持在病人体外。接着,装置6可以操纵成使得外管状部件76的窗口89可以安置成靠近肌瘤或其它的目标组织。然后,真空源392可以操作成使得抽吸施加于内管状部件77,从而通过窗口89将组织吸取到外管状部件76内。另外,马达驱动组件11的马达可以被致动,从而同时使内管状部件77转动和在外管状部件76内平移地来回摆动,导致吸入穿过窗口89的组织被切割。接着,被切割的组织可以借助于上述抽吸从病人体内抽吸穿过内管状部件77,并且此后,收集在容器391中。一旦子宫肌瘤或其它的目标组织已经因此被从病人体内移除,则真空源392和马达可以关闭,装置6可以从导引器7撤出,并且导引器7可以从病人体内撤出。装置6可以设计成一次性装置。如果这样,装置6则可以与抽空管393和柔性马达轴398-2断开并且被妥善处理。
应当注意,虽然以上的讨论考虑利用导引器7将装置6引入到子宫中,但是可以将装置6经子宫颈地插入到子宫内而不使用导引器7。在这种情况下,流体可以通过流体分配装置经子宫颈地给予到子宫以使子宫膨胀,并且此后,可以例如通过利用经子宫颈地插入到子宫内的超声波探针的超声波成像来完成子宫的观察。这种超声波探针可以与装置6分开或可以集成到装置6中。可替代地,可以通过MRI成像执行子宫的成像。
虽然可以改变内管状部件77的转动运动的速度、内管状部件77的摆动平移运动的频率、内管状部件77的前进比(即,管状部件77平移地摆动的速度与管状部件77转动的速度的比)以及由真空源392提供抽吸的大小中的一个或更多个,但是已经在下列条件下实现特别良好的结果:管状部件77的转动的速度,至少1100rpm、更优选为至少5000rpm、甚至更优选为大约6000rpm;管状部件77的摆动平移运动的频率,至少1.5周期/秒、更优选为大约2.5周期/秒至4周期/秒、甚至更优选为大约2.8周期/秒;优选为小于0.25、更优选为小于0.15的前进比;以及在200mmHg至650mmHg的范围中的真空压力。优选地,以上参数选择成达到至少1.5gm/min的组织移除的速率,而同时外管状部件76具有不大于大约3.0mm的外径。
如可以理解的,当抽吸施加于内管状部件77时,位于子宫中的膨胀流体中的一些可以通过内管状部件77从子宫附带地抽出。如果来自子宫的膨胀流体的该损失干扰子宫的处于充分膨胀状态的保持,则来自子宫的膨胀流体的该损失可能是不良的。优选地,系统5构造和操作成使得在真空超过300mmHg的情况下,移除不大于大约300cc/min的体积的流体。其可以涉及例如,仅在特定的时间,例如,仅在用于使内管状部件77移动的马达致动时,或通过每当马达控制停止时利用内管状部件77使切除窗口89关闭来施加抽吸。
通常,切碎器可以根据本发明构造成具有比诸如Smith&Nephew子宫镜切碎器之类的当前商业产品的外径或横截面小的外径或横截面,但是同时实现更高的组织切除速率。另外,根据本发明的切碎器可以在明显更高的真空下操作,同时将总流体流动控制在可接受的范围内。
例如,根据本发明的切碎器中的吸取内腔的横截面面积通常将为不大于大约12.0平方毫米,并且经常不大于大约10.0平方毫米。在某些实施方式中,吸取内腔的横截面面积将不大于大约8.0平方毫米,并且对于某些应用,面积将为不大于大约7.5平方毫米。
组织切除速率通常为至少大约1.5gm/min,并且经常为至少大约1.8gm/min。在某些实施方式中,组织切除速率为至少大约2.0gm/min,并且在一个实施方式中为2.2gm/min或更多。
根据本发明的切碎器可以被构造成具有不大于大约350ml/min的流体用量。在某些实施方式中,可以构造成不大于大约300ml/min或不大于大约275ml/min的流体用量。
施加于本发明的切碎器的真空通常将在从大约200mmHg到大约650mmHg的范围内。切碎器通常将在至少大约350mmHg并且常常在至少大约500mmHg的真空下运行。
在本发明的一个实施方式中,吸取内腔的横截面面积为大约7.1mm2,并且在大约600mmHg的真空下产生大约1.4gm/min的组织切除速率。
通常,根据本发明完成的过程将要求不大于大约10分钟,并且优选为不大于大约8分钟或9分钟的主动切碎。在这段时间内,引入到子宫内的总流体(例如,盐水)通常将为不大于大约12升,并且优选为不大于大约10升或8升。膨胀流体将优选地保持处于足够低的压力和足够短的时间,以使总盐水内渗保持在2.5升以下。
在根据本发明的常用过程中,利用具有3mm的外径的切碎器,用于盐水的穿过切碎器的吸取的流体流动速率为大约260ml/min(例如,在从大约240ml/min到大约280ml/min的范围内)。因此,在十分钟的过程中,大约2.6升的盐水被吸取穿过切碎器。在相同的过程中,组织切除速率通常超过大约2gm/min。
在比较实验中,根据本发明制造的装置与来自Smith&Nephew的往复式子宫镜切碎器的性能进行比较。在利用预计装置进行的一系列实验中,真空平均地保持在200mmHg到270mmHg的范围内,切碎器速度为大约1100rpm,组织切除速率为大约1.4gm/min,穿过切碎器的流体流动速率为大约247ml/min,并且切碎器的外径为4.0mm。
根据本发明构造的装置在600mmHg的真空和大约6000rpm的速度下操作,以通过切碎器产生大约2.2gm/min的切除速率和大约266ml/min的吸取流动速率。装置的外径为3mm。
因此,根据本发明的切碎器以吸取盐水的大致相当的流动速率通过较小外径的切碎器产生明显更高的切除速率。为了使预计装置的切除速率增大,真空必须显著地增大。例如,当预计系统中的真空压力增大至大约670mmHg时,组织切割改进至3.5gm/min,但是流体流动速率跳至540ml/min。
响应于增大的真空的增大的流体流动速率的一个挑战是代替流体必须以相等的速率浸入到作业地点。为了以足够的速率注入流体以使预计装置能够在更高的真空下运行,已经较大的预计切碎器的直径必须增大。申请人已经确定此处公开的切碎器的与光学系统结合的使用使子宫颈的扩张能够限制到不大于大约5.5mm,其中,切碎器的外径不大于约3mm。使切碎器的直径增大以适合更高的注入速率以及增大预计系统的已经较大的外径被认为越过痛觉阈值并且显然需要或期望在全身麻醉的情况下执行过程。申请人认为,对于许多病人,能够避免全身麻醉更有益处。
现在参照图10(a)和10(b),示出可以使用在组织移除装置6中的某些替代性内管状部件的局部纵向截面图。第一这种替代性内管状部件在图10(a)中示出并且总体以附图标记411表示。内管状部件411可以在某些方面与内管状部件77相似;然而,两个管状部件之间的一个显著区别是内管状部件411可以通过使分开的两个材料件连结在一起来形成,而内管状部件77可以为由单个材料件制成的整体形结构。更具体地,内管状部件411可以包括近端杆413形式的第一件和远端尖端415形式的第二件,其中,远端尖端415优选地具有比切除窗口89的长度更长的长度,并且更优选地具有小于大约2英寸的长度,且在一个构造中大约1英寸的长度。近端杆413和远端尖端415可以由相同的材料制成或可以由不同的材料制成。诸如硬度超过大约50的洛氏C硬度的400系列不锈钢(例如,440C不锈钢)之类的相对较硬的不锈钢材料优选地用于远端尖端415,因为这些材料使得远端尖端415能够产生更锐利的边缘。另一方面,诸如300系列不锈钢(例如,304不锈钢)之类的低硬度不锈钢材料可以优选地用于近端杆413,因为这些材料可以例如通过挤压相对廉价地形成为长的管状结构,而较硬的不锈钢材料必须机加工以形成管状结构。这些近端管材料的洛氏C硬度为小于大约40。近端杆413和远端尖端415可以通过焊接或其它合适的技术连结在一起。取决于期望的性能,可以使用各种切割器刃和窗口构造中的任何一个,包括在Gruber等人的2008年4月4日提交的美国专利申请序列号No.12/098,250中公开的那些性能中的任何一个,该申请的公开内容被全部结合在此,作为参考。
管状部件411和管状部件77之间的另一显著区别是尽管管状部件77可以在其整个长度上具有均一的内径,但是远端尖端415的内径与近端杆413的内径相比可被减小(例如,0.082英寸对0.085英寸)。申请人相信,当具有与远端尖端415相似的外径的切割标本从远端尖端415移动到具有比切割标本的直径大的直径的近端杆413内时,从远端尖端415到近端杆413的内径方面的该增大可以导致在管状部件411中堵塞发生率的降低。近端杆413内的间隙便于标本的穿过管状部件411的近端运动。
第二替代性内管状部件在图10(b)中示出并且总体上以附图标记421表示。管状部件421可以在某些方面与管状部件411相似,两个管状部件之间的主要区别是管状部件421可以为由单个材料件制成的整体形结构,该单个材料件可以是例如17-7系列不锈钢。为了由具有均一内径的管状结构形成管状部件421,首先可以锻压或轧制管状结构的远端端部以减小远端端部的内径,并且接着可以通过机械珩磨、扩张或化学蚀刻使结构的剩余部分的内径增大。
现在参照图11,示出可以使用在组织移除装置6中的替代性指示器套筒431的侧视图。指示器套筒431可以在大多数方面与指示器套筒98相似,两个指示器套筒之间的主要区别是套筒431可以沿着其长度设有标记或未标记的等级433以表示每个等级和套筒431的远端端部431-1之间的距离。因为套筒431的尺寸优选地设计成并且套筒431安置成使得套筒431的远端端部431-1表示装置6的远端端部92何时与导引器7的远端端部对齐,等级433表示装置6的远端端部92和导引器7的远端端部之间的相对距离。等级433可以包括:例如,数字标记、符号、码标、环等。
现在参照图12,其中以局部截面图示出可以使用在组织移除系统5中的组织移除装置和导引器的替代性组合的局部侧视图,所述组织移除装置总体以附图标记441表示,并且所述导引器总体以附图标记443表示。
装置441和导引器443可以在大多数方面与装置6和导引器7相似,主要区别是装置441可以包括固定地安装在溢放口部件74上的位置指示器环445而不是套筒98,并且导引器443可以包括近端部447而不是本体201的近端部203,近端部447适当地成形为仅提供与环445上的隆起部445-1和445-2的足够干扰,使得可给予用户环445正在插入到近端部447中的触觉指示。
现在参照图13(a)和13(b),其以局部截面图示出可以使用在组织移除系统5中的组织移除装置和导引器的另一替代性组合的局部侧视图,所述组织移除装置总体以附图标记451表示,并且所述导引器总体以附图标记453表示。
装置451可以与装置441完全相同。导引器453可以在大多数方面与导引器7相似,两个导引器之间的主要区别是导引器453可以成形为包括声室455并且可以附加地包括弹簧夹或弹簧箍457。夹457可以具有固定端部457-1和自由端部457-2,固定端部457-1安装在声室455内,自由端部457-2构造成当环445在远端移动经过夹457时通过环445偏转。夹457的通过环445的偏转使夹457摆动并且产生听觉信号。
现在参照图14,以局部截面图示出可以使用在组织移除系统5中的替代性组织移除装置的局部侧视图,所述组织移除装置总体以附图标记470表示。装置470的对本发明的理解不重要的某些方面未在此处示出和描述。
装置470在大多数方面可以与装置6相似,两个装置之间的主要区别是:尽管装置6可以包括包含与轴72的齿轮形远端部72-2啮合的直齿轮51的旋转机构,但是装置470可以包括包含轴472的转动机构,该轴472包括管状弹性远端部472-2,其接合用于与固定地安装在固定地联接于平移驱动轴35的圆柱形部件478的凹槽476内的弹性O形环474一起转动。
现在参照图15(a)和15(b),分别示出可以使用在组织移除系统5中的另一替代性组织移除装置的局部立体图和局部分解立体图,所述组织移除装置总体以附图标记500表示。装置500的对本发明的理解不重要的某些方面未在此处示出和描述。
装置500可以在许多方面与装置6相似,各自的组织移除装置之间的一个区别是:装置500可包括安装托架501。托架501可以成形为包括基部部分503、近端块505、远端块507以及中间块509,托架501可以为由刚性金属或聚合物制成的整体形结构,近端块505从基部部分503的近端端部向上延伸,远端块507从基部部分503的远端端部向上延伸,中间块509从基部部分503的中间部向上延伸。
装置500和装置6之间的另一区别是:尽管装置6可包括内部驱动轴21、平移驱动轴35以及齿轮组件50,而装置500可以包括内部驱动轴510、平移驱动轴511以及齿轮组件512。内部驱动轴510可以成形为包括近端端部513和远端端部515,内部驱动轴510可以是由合适的刚性金属或聚合物制成的细长整体形结构。轴510的近端端部513可以同轴地安装在外部驱动轴29的远端端部上面并且固定于外部驱动轴29的远端端部。以此方式,轴510的转动可以机械地联接于轴29的转动。轴510的中间部可以容纳在设置在支架501的块505中的纵向孔520内。齿轮组件512可以固定地安装在轴510的远端端部515上以致与轴510一起转动。齿轮组件512可以包括较大直径的近端直齿轮523和较小直径的远端直齿轮525。平移驱动轴511可以成形为包括近端端部537、中间部539以及远端端部541,平移驱动轴511可以是由合适的刚性金属或聚合物制成的细长整体形结构。轴511的近端端部537可以是可以与远端齿轮525啮合的直齿轮的形状。以此方式,轴511的转动可以机械地联接于轴510的转动,其中,轴511的转动速度取决于轴510的转动速度和齿轮525和近端端部537的相对大小。中间部539可以延伸穿过设置在托架501的块509中的纵向孔509-1。中间部539可以成形为包括与轴35的双螺旋部相似的双螺旋部540。轴511的远端端部541的尺寸可以适当地设计成容纳在设置于托架501的块507中的开口544内。应当注意,虽然轴511适合于转动,但是轴511可以在平移中静止。
装置500和装置6之间的另一区别是:尽管装置6可以包括机械地联接于内管状部件77以致与其一起转动和平移地摆动的轴72,而装置500可以包括机械地联接于内管状部件77以致与其一起转动和平移地摆动的细长轴551。轴551可以成形为包括与近端齿轮523啮合的直齿轮,轴551可以为由刚性金属或聚合物制成的整体形管状结构。齿轮可以是细长的使得即使当齿轮相对于近端齿轮523平移地移动时,其也可以保持与近端齿轮523啮合。取决于例如,两个齿轮的相对直径(两个齿轮的转动速度的比与两个齿轮的直径的比成反比),轴551转动的速度可以与齿轮523转动的速度相同或不同。因此,通过适当地设计齿轮的尺寸,可以实现期望的转动速度,甚至其中,外部驱动轴的转速是固定的。例如,在示出的实施方式中,轴551的齿轮可以具有为齿轮523的直径的三分之一的直径,并且因此以齿轮523的三倍的速度转动。同时,轴511的近端端部537可以具有为齿轮525的直径的三分之四的直径,并且因此以齿轮525的四分之三的速度转动。因此,如果外部驱动轴具有大约2000rpm的转速,则轴551(和内管状部件77)将以大约6000rpm转动,并且轴511将以大约1500rpm转动,在双螺旋部适当地成形的情况下,轴511可用于实现用于内管状部件77的大约2.8周期/秒的摆动平移速度。
现在参照图16,示出可以使用在组织移除系统5中的替代性组织移除装置的局部侧视图,所述组织移除装置总体上以附图标记570表示。装置570的对本发明的理解不重要的某些方面未在此处示出和描述。
装置570可以在许多方面与装置6相似。两个装置之间的一个区别可以是:尽管装置6可以将内部驱动轴21固定于外部驱动轴29以便与外部驱动轴29一起转动,并且可以通过轴72和齿轮51的接合将内管状部件77的转动联接于内部驱动轴21,而装置570可以将内管状部件77固定于外部驱动轴29以便与外部驱动轴29一起转动,并且可以通过一对直齿轮572和574的啮合将内部驱动轴21的转动联接于内管状部件77。齿轮572可以同轴地插入在内管状部件77上面并且固定于内管状部件77,齿轮574可以同轴地插入在内部驱动轴21上面并且固定于内部驱动轴21。齿轮572和574的大小可以分别设计成例如具有1:4的比,使得如果外部驱动轴29以大约6000rpm转动,则内管状部件77也以大约6000rpm转动,而内部驱动轴21以大约1500rpm转动。
现在参照图17,示出可以使用在组织移除系统5中的替代性组织移除装置的局部侧视图,所述组织移除装置总体以附图标记580表示。装置580的对本发明的理解不重要的某些方面未在此处示出和描述。
装置580可以在许多方面与装置6相似。两个装置之间的一个区别可以是:尽管装置6可以将内部驱动轴21固定于外部驱动轴29以便与外部驱动轴29一起转动,并且可以通过轴72和齿轮51的接合将内管状部件77的转动联接于内部驱动轴21,而装置580可以通过一对直齿轮582和584的接合将内部驱动轴21的转动联接于外部驱动轴29,并且可以通过直齿轮586的与齿轮582的接合将内管状部件77的转动联接于外部驱动轴29。齿轮582可以同轴地插入在外部驱动轴29上面并且固定于外部驱动轴29,齿轮584可以同轴地插入在内部驱动轴21上面并且固定于内部驱动轴21,齿轮586可以同轴地插入在内管状部件77上面并且固定于内管状部件77。齿轮582和584的大小可以分别设计成例如具有1∶2的比,并且齿轮582和586的大小可以分别设计成例如具有2∶1的比。以此方式,如果外部驱动轴29以大约3000rpm转动,则内管状部件77以大约6000rpm转动,并且内部驱动轴21以大约1500rpm转动。
现在参照图18,示出可以使用在组织移除系统5中的替代性组织移除装置的局部立体图,所述组织移除装置总体以附图标记600表示。装置600对本发明的理解不重要的某些方面未在此处示出和描述。
装置600可以在许多方面与装置6相似。两个装置之间的一个区别可以是用于使内管状部件77转动和使内管状部件77平移地往复运动的它们各自的机构。更具体地,装置600可以包括固定于外部驱动轴(未示出)以便与该外部驱动轴一起转动的内部驱动轴603。内部驱动轴603可以包括近端部605和远端部607。直齿轮609和锥齿轮611可以同轴地安装在远端部607上面并且固定于远端部607以便与远端部607一起转动,其中,锥齿轮611相对于直齿轮609在远端安置。直齿轮613可以同轴地安装在内管状部件77上面并且固定于内管状部件77以便与内管状部件77一起转动,齿轮613与齿轮609啮合以使内部驱动轴603的转动引起内管状部件77的转动。(与驱动轴603的转动速度相比,内管状部件77的转动速度可以通过齿轮609和613的相对直径控制)。相对于内部驱动轴603在远端安置的锥齿轮615可以与锥齿轮611啮合。鞍座619可以同轴地安装在内管状部件77上面,鞍座619固定于内管状部件77以便与内管状部件77一起平移运动,但是允许管状部件77在其中自由地转动。鞍座619和锥齿轮615可以通过从齿轮615的顶部表面621向上延伸的销(未示出)和设置在鞍座619的底部表面上的狭槽(未示出)相互联接,鞍座619中的狭槽接收锥齿轮615上的销。鞍座619中的狭槽可以垂直于内管状部件77的纵向轴线定向,并且鞍座619中的狭槽的尺寸适当地设计成使得当锥齿轮615转动时,锥齿轮615上的销在鞍座619中的狭槽内来回行进。以此方式,锥齿轮615的转动可以引起内管状部件77的平移摆动。
现在参照图19,示出可以使用在组织移除系统5中的替代性组织移除装置的局部立体图,所述组织移除装置总体以附图标记700表示。装置700的对本发明的理解不重要的某些方面未在此处示出和描述。
装置700可以在许多方面与装置6相似。两个装置之间的一个区别可以是用于使内管状部件77转动和使内管状部件77平移地往复运动的它们的各自的机构。更具体地,装置700可以包括固定于外部驱动轴(未示出)以致与该外部驱动轴一起转动的内部驱动轴703。直齿轮705和平移凸轮707可以同轴地安装在驱动轴703上面并且固定于驱动轴703以便与驱动轴703一起转动,其中,平移凸轮707相对于直齿轮705在远端安置。直齿轮711可以同轴地安装在内管状部件77上面并且固定于内管状部件77以便与内管状部件77一起转动,齿轮711与齿轮705啮合使得内部驱动轴703的转动引起内管状部件77的转动。(与驱动轴703的转动速度相比,内管状部件77的转动速度可以通过齿轮705和711的相对直径控制)。鞍座713可以同轴地安装在内管状部件77上面,鞍座713固定于内管状部件77以便与内管状部件77一起平移运动但是允许管状部件77在其中自由地转动。鞍座713和平移凸轮707可以通过从鞍座713向下延伸的销(未示出)和设置在凸轮707中的环形凹槽717相互联接,凹槽717接收鞍座713上的销。凸轮707中的凹槽717可以成形为从凸轮707的大约近端端部707-1延伸至凸轮707的大约远端端部707-2,并且在凸轮707的一个转动的过程中后退至凸轮707的大约近端端部707-1。以此方式,当凸轮707转动并且销在凹槽717内来回行进时,内管状部件77可以对应地平移摆动。
现在参照图20,示出可以使用在组织移除系统5中的替代性组织移除装置的局部立体图,所述组织移除装置总体以附图标记800表示。装置800对本发明的理解不重要的某些方面未在此处示出和描述。
装置800可以在许多方面与装置6相似。两个装置之间的一个区别可以是用于使内管状部件77转动和使内管状部件77平移往复运动的它们的各自的机构。更具体地,装置800可以包括固定于外部驱动轴(未示出)以便与该外部驱动轴一起转动的内部驱动轴801。直齿轮803可以同轴地安装在驱动轴801上面并且固定于驱动轴801以致与驱动轴801一起转动。另外,平移凸轮805可以同轴地安装在驱动轴801上面并且固定于驱动轴801以便与驱动轴801一起转动。平移凸轮805可以包括管状部805-1和盘部805-2,盘部805-2以相对于管状部805-1的纵向轴线成非垂直的角度固定地安装在管状部805-1上。直齿轮813可以同轴地安装在内管状部件77上面并且固定于内管状部件77以便与内管状部件77一起转动,齿轮813与齿轮803啮合使得内部驱动轴801的转动引起内管状部件77的转动。(与驱动轴801的转动速度相比,内管状部件77的转动速度可以通过齿轮803和813的相对直径控制)。鞍座819可以同轴地安装在内管状部件77上面,鞍座819固定于内管状部件77以便与内管状部件77一起平移运动,但是允许管状部件77在其中自由地转动。鞍座819可以成形为包括凹部821,该凹部821可以接收盘部805-2的顶部。以此方式,当驱动轴801转动时,使盘部805-2来回“摇摆”,鞍座819和因此内管状部件77可以对应地平移摆动。
现在参照图21,示出可以使用在组织移除系统5中的替代性组织移除装置的局部立体图,所述组织移除装置总体以附图标记900表示。装置900对本发明的理解不重要的某些方面未在此处示出和描述。
装置900可以在许多方面与装置6相似。两个装置之间的一个区别可以是用于使内管状部件77转动和使内管状部件77平移地往复运动的它们的各自的机构。更具体地,装置900可以包括固定于外部驱动轴(未示出)以致与该外部驱动轴一起转动的内部驱动轴901。直齿轮903和蜗轮905可以同轴地安装在驱动轴901上面并且固定于驱动轴901以便与驱动轴901一起转动。直齿轮907可以同轴地安装在内管状部件77上面并且固定于内管状部件77以便与内管状部件77一起转动,齿轮907与齿轮903啮合使得内部驱动轴901的转动引起内管状部件77的转动。(与驱动轴901的转动速度相比,内管状部件77的转动速度可以通过齿轮903和907的相对直径控制)。蜗轮911可以与蜗轮905接合,使得当蜗轮905转动时蜗轮911转动。销913可以安装在蜗轮911的正面911-1的外围附近。往复运动臂915可以具有固定于销913的第一端部和固定于平移地联接于内管状部件77的块917的第二端部。以此方式,当蜗轮911转动并且销913在蜗轮911上的位置改变时,臂915使块917和内管状部件77平移地来回移动。
如可以理解的,当组织移除装置留在病人体内,但是用于组织移除装置的切割马达已经被暂时关闭时,例如,在组织移除装置的操作员使切割停止以检查病人期间,期望使膨胀流体通过组织移除装置从病人的子宫流出的量最小化。至少对于损失的膨胀流体将需要被重新装满以使子宫保持膨胀的原因而言,膨胀流体的这种损失是不良的。在装置6中,通过检测用于装置6的马达何时将被关闭和在那此情形中,通过将内管状部件77相对于外管状部件76平移地安置成使得切除窗口89关闭而通过电子设备解决该问题。解决该问题的替代性方法以在图22(a)至22(e)中示出的组织移除装置940为示例。装置940对本发明的理解不重要的某些方面未在此处示出和描述。
装置940可以在某些方面与装置6相似。然而,各装置之间的一个区别是装置940可以包括具有封闭近端端部945和侧向窗口947的内管状部件943。弹簧座949可以同轴地安装在内管状部件943上面并且固定于内管状部件943以便与内管状部件943一起转动。弹簧951的近端端部可以固定于弹簧座949,并且弹簧951的远端端部可以固定于同轴地安装在内管状部件943上面的阀部件953,阀部件953能够相对于内管状部件943转动。阀部件953可以包括侧向窗口955。依靠内管状部件943和阀部件953的各自的转动位置,侧向窗口955能够与侧向窗口947对齐。止动件957可以形成在内管状部件943上,止动件957能够与阀部件953可拆卸地接合以使阀部件953的转动与内管状部件943联接。真空外壳959可以同轴地安装在阀部件953上面,阀部件953能够在真空外壳959内自由地转动。外管状部件76可以固定地安装在真空外壳959上。一对O形环961-1和961-2可以设置成起到密封件的作用。
在装置940的切割马达致动之前,阀部件953的侧向窗口955和内管状部件943的侧向窗口947成90度,不相互对齐。然而,一旦装置940的切割马达被致动,则内管状部件943开始转动。其使弹簧951试图松开,由此使阀部件953转动以使阀部件953的侧向窗口955与内管状部件943的侧向窗口947对齐。在阀部件953因此转动地与内管状部件943对齐的情况下,止动件957防止阀部件953相对于内管状部件943进一步转动。当装置940的切割马达接着被关闭时,弹簧951使阀部件953相对于内管状部件943转动回到其初始方位。
如上所述,导引器7优选地包括阀233,阀233设计成在装置6不插入到导引器7内时阻止流体从病人体内溢出。然而,可以存在期望同时使流体流入到病人体内和从病人体内流出而装置6不插入到导引器7内的情形。因此,现在参照图23,示出安置在导引器7的通道内的闭塞器965的局部截面图。闭塞器965可以成形为包括钝的远端端部967和通向纵向延伸通道971的多个开口969。如示出的,闭塞器965可以安置在仪器通道196中,或可以安置在流体输入通道198-1或流体输入通道198-2中,以提供双向流体流动(例如,其中,流体离开通道198-1或198-2流入在通道198-1或198-2与闭塞器965之间的空间中,以及其中,流体流出通过开口969进入闭塞器965)。通过开口969进入通道971的流体流出可以通过闭塞器965的近端端部(未示出)离开闭塞器965。
在图24中示出替代性闭塞器972,闭塞器972具有在沿着其长度的中间位置处的侧向开口973,侧向开口973与设置在替代性导引器977中的流出流体通道975对齐。如果需要,闭塞器972可以由具有弯曲性的弹性部件制成,并且导引器977可以设有由柔性材料制成的护套978。以此方式,闭塞器972可以用于为护套978提供弯曲,通过使闭塞器972的近端端部979转动,护套978可以用于操纵护套978的远端端部。
现在参照图25(a)和25(b),示出根据本发明的闭塞器和导引器的替代性组合,闭塞器总体以附图标记980表示,并且导引器总体以附图标记981表示。
闭塞器980可以包括远端部件982和近端部件983,闭塞器980可以在许多方面与闭塞器965相似。远端部件982可以是管状的并且可以包括开放远端端部984、封闭近端端部985以及侧向开口986,其中,近端部件983安装在远端部件982的近端端部985上面。
导引器981可以在许多方面与导引器7相似,相应的导引器之间的一个区别是:导引器981可以附加地包括流体流出通道987。通道987可以包括远端端部987-1,当闭塞器980安装在导引器981中时,远端端部987-1可以与闭塞器980的侧向开口986对齐。以此方式,流出流体可以从闭塞器980流动至通道987并且可以通过通道987的近端端部987-2离开导引器981。导引器981可以附加地包括阀988-1和阀988-2。阀988-1可以用于控制流体通过通道987的流动,阀988-1可以为旋塞阀。阀988-2可以用于控制流体通过流入通道989的流动,阀988-2可以为旋塞阀。
现在参照图26(a)至26(c),示出导引装置7的替代性导引装置的各种视图,替代性导引装置总体以附图标记990表示。
导引装置990可以在许多方面与导引装置7相似,导引装置990和导引装置7之间的一个区别可以是:尽管导引装置7可以包括具有顶部内腔196、底部内腔197以及一对侧向内腔198-1和198-2的护套191,但是导引装置990可以包括顶部管状部件991、底部管状部件992、套筒993以及远端盖994。顶部管状部件991可以用作例如容纳例如组织移除装置6或闭塞器965的仪器通道。如示出的,底部管状部件992可以用于例如容纳子宫镜8的远端端部319。套筒993的尺寸可以适当地设计成同轴地容纳顶部管状部件991和底部管状部件992,并且套筒993可以成形为限定在套筒993的内表面和管状部件991和992的外表面之间的空间中的、在管状部件991和992的相反侧的一对流体通道995,套筒993可以由不锈钢等制成。多个横向开口996可以靠近套筒993的远端端部997设置在套筒993上,开口996提供流体通道995的侧向进入。以此方式,可以通过使流体在远端穿过通道995并且接着通过开口996径向地离开来提供至病人体内的流体流入。从病人体内流出的流体可以在近端穿过盖994行进并且接着在近端穿过顶部管状部件991(例如,通过穿过安置在顶部管状部件991中的仪器)。可以认为由导引装置990提供的流体流动方式可以在从病人体内移除血液和其它不良流体方面特别有效。盖994可以包括保持器998,保持器998可以容纳管状部件991和992的远端端部,并且保持器998可以插入到套筒993的远端端部997内并且固定于套筒993的远端端部997。
现在参照图27,示出组织移除系统的第二实施方式的部分分解立体图,组织移除系统根据本发明的教导构造并且总体以附图标记1007表示。
系统1007可以包括组织移除装置1008、真空组件1009以及马达驱动组件1010。虽然未在本实施方式中示出,但是系统1007还可以包括与以上描述的系统5的导引装置、柔性子宫镜以及流体供应件相似的导引装置、柔性子宫镜以及流体供应件。
组织移除装置1008可以包括切碎器组件1013和驱动组件1015,切碎器组件1013以在下面进一步描述的方式可移除地安装在驱动组件1015上。
现在参照图28(a)至28(d),可以更详细地看到切碎器组件1013。切碎器组件1013可以包括外壳1021。外壳1021可以是成形为包括近端端部1023、远端端部1025以及侧壁1027的大致管状的部件,外壳1021可以为由刚性聚合物或金属制成的细长整体形结构。侧壁1027可以是通常圆筒形,其中,其底部表面的部分1028是倾斜的。纵向内腔1029可以从近端端部1023延伸至远端端部1025。内腔1029的中间部1031可以在直径方面扩大并且能够通过侧壁1027上的开口1033进入。内腔1029的从近端端部1023向远端延伸至与中间部1031在近端隔开的点的近端部1035可以在直径方面扩大并且可以具有内螺纹。
切碎器组件1013可以附加地包括一对管状衬套1041和1043。衬套1041可以靠近内腔1029的中间部1031的近端端部置于内腔1029的中间部1031内,并且可以利用螺钉1042固定地紧固于外壳1021,衬套1041可以为由刚性聚合物或金属制成的整体形结构。衬套1043可以靠近内腔1029的中间部1031的远端端部置于内腔1029的中间部1031内,并且可以利用螺钉1044固定地紧固于外壳1021,衬套1043可以为由刚性聚合物或金属制成的整体形结构。衬套1041可以成形为包括孔1045,并且衬套1043可以成形为包括孔1047,孔1045和1047与外壳1021的内腔1029同轴地对齐。
切碎器组件1013可进一步包括细长轴1051。轴1051可以成形为包括近端部1053、远端部1055、中间部1057以及纵向孔1059,轴1051可以为由黄铜或另一合适的刚性金属或聚合物制成的整体形结构。轴1051的近端部1053可能够滑动地安装在衬套1041的孔1045中,并且轴1051的近端部1053的大小可以设计成在衬套1041的孔1045内自由地转动。轴1051的远端部1055可能够滑动地安装在衬套1041的孔1047中,并且轴1051的远端部1055的大小可以设计成在衬套1041的孔1047内自由地转动。轴1051的中间部1057可以安置在衬套1041和1043之间并且可以呈现为具有相对于近端部1053和远端部1055增大的外径的齿轮形状。
切碎器组件1013可进一步包括平移联接块1061。块1061可以是成形为包括近端端部1063、远端端部1064、侧壁1065以及纵向孔1066的管状部件,块1061可以为由刚性聚合物或金属制成的整体形结构。块1061可以同轴地安装在轴1051的近端部1053上面,其中,孔1066的大小相对于近端部1053设计成使得近端部1053能够在孔1066内自由地转动。块1061的侧壁1065可以成形为大致对应于内腔1029的中间部1031的形状。以此方式,块1061可以在外壳1021内保持在转动中的静止。块1061可以相对于轴1051平移地固定,其中,扣环1067同轴地插入在近端部1053上面并且利用固定螺钉1068固定于近端部1053。垫圈1069可以在块1061的远端端部1063和轴1051的中间部1057之间同轴地插入在轴1051的近端端部1053上面,以防止当中间部1057转动时由中间部1057和块1061的远端端部1063之间的接触引起的任何磨损。块1061的侧壁1065可进一步成形为包括减小的外径的腰部1070。以此方式,在块1061同轴地安装在轴1051的近端部1053上面的情况下,一对狭槽1071-1和1071-2可以形成在块1061和外壳1021之间。
切碎器组件1013可进一步包括溢放口部件1072。溢放口部件1072可以是成形为包括近端部1073和远端部1074的管状部件,溢放口部件1072可以为由刚性聚合物或金属制成的整体形结构。近端部1073可以在直径方面比远端部1074略大并且可以包括分叉狭槽1075。溢放口部件1072的近端部1073可以布置在内腔1029的远端部内,其中,溢放口1072的远端部1074从外壳1021的远端端部1025向远端延伸一短距离,诸如,例如大约2英寸。
切碎器组件1013可进一步包括切割机构。在本实施方式中,切割机构可以包括外管状部件1076和内管状部件1077,内管状部件1077转动地移动并且同时以在下面进一步描述的方式相对于外管状部件1076平移地摆动。外管状部件1076可以成形为包括开放近端端部1079、封闭远端端部1081以及内腔1083,外管状部件1076可以为由不锈钢或另一类似合适的材料制成的整体形结构,内腔1083从开放近端端部1079延伸至刚好在封闭远端端部1081之前的点。部件1076可以同轴地安装在溢放口部件1072内,其中,部件1076的近端端部1079布置在溢放口部件1072的近端部1073内,并且其中,部件1076的远端端部1081向远端延伸超过溢放口部件1072的远端部1074一延长的距离,诸如,例如五英寸。部件1076的近端端部1079和溢放口部件1072的近端部1073的组合可以利用插入穿过外壳1021上的开口1087的螺钉1085固定地保持在外壳1021中,螺钉1085使溢放口部件1072的近端部1073紧密压靠在部件1076的近端端部1079上。
外管状部件1076可进一步成形为包括切除窗口1089,组织可以被捕捉并吸入到切除窗口1089内,窗口1089定位成靠近远端端部1081,诸如,例如距该远端端部0.25英寸。窗口1089可以成形为包括近端端部1089-1和远端端部1089-2。近端端部1089-1可以向近端逐渐倾斜,并且远端端部1089-2可以向远端逐渐倾斜。更具体地,窗口1089可以具有大约0.55英寸的长度,近端端部1089-1可以为具有例如0.085英寸的曲率半径的径向端部,并且远端端部1089-2可以为具有例如0.150英寸的曲率半径的径向端部。窗口1089可以管状部件1076的圆周的大部分上面延伸,诸如,例如圆周的大约60%。
外管状部件1076可以具有小于大约5.5mm的外径。然而,为了降低伤害病人的风险并且为了避免必须对病人施行麻醉,外管状部件1076优选地具有小于大约5mm的外径、更优选为小于4mm的外径、甚至更优选为小于3mm的外径以及又甚至更优选为小于2mm的外径。
内管状部件1077可以成形为包括近端端部1091、远端端部1092以及纵向内腔1093,内管状部件1077可以为由不锈钢或另一类似合适的材料制成的细长整体形结构。远端端部1092可以成形为包括外部斜面,诸如,例如大约20度的外部斜面。管状部件77的中间部可以容纳在轴1051的孔1059内,并且可以利用扣环1094-1、开槽套筒1094-2以及一对固定螺钉1095固定地联接于轴1051以便与其一起平移运动和转动运动。环1094-1的近端部可以拧到轴1051的远端端部上,其中,环1094-1的远端部在部件1077上面延伸。套筒1094-2可以同轴地插入在部件1077和环1094-1之间,并且固定螺钉1095可以插入穿过扣环1094-1中的横向开口1096以将环1094-1和套筒1094-2联接于部件1077。管状部件1077可以具有合适的长度,使得在管状部件1077处于完全缩回(即,近端)位置时,管状部件1077的近端端部1091可以从外壳1021的近端端部1023向近端延伸一短距离,并且管状部件1077的远端端部1092可以充分地撤回以允许组织进入窗口1089。同时,管状部件1077可以具有长度使得在管状部件1077处于完全前进(即,远端)位置时,管状部件1077的远端端部1092可以在窗口1089的远端端部1089-2的远端处安置。
切碎器组件1013可进一步包括配件1097。配件1097可以是成形为包括近端部1098、远端部1099以及纵向内腔1100的管状部件,配件1097可以为由刚性聚合物或金属制成的整体形结构。近端部1098可以通过一定长度的管联接于真空组件1009,近端部1098可以有毛刺。配件1097的远端部1099可以具有外螺纹以便与外壳1021的近端部1035匹配地接合。配件1097的内腔1100的尺寸可以设计成可滑动地接收管状部件1077的近端端部1091。O形环1101可以布置在内腔1100内,以围绕管状部件1077提供密封。
现在参照图29(a)和29(b),可以更详细地看到驱动组件1015。驱动组件1015可以包括主体1105。主体1105可以是成形为包括远端端部1107、近端端部1109以及侧壁1111的大致槽状部件,主体1105可以为由刚性聚合物或金属制成的整体形结构。远端端部1107可以为大致圆形并且可以包括包含中央部1115和外围部1117的远端表面。中央部1115可以相对于外围部1117凹进。中央横向开口1119可以设置在中央部1115中,并且一对较小的横向开口1120可以在中央开口1119的相对侧设置在中央部1115中。近端端部1109可以为大致圆形并且可以包括包含中央部1123和外围部1125的近端表面。中央部1123可以相对于外围部1125凹进。中央横向开口1127可以设置在中央部1123中,并且一对较小的横向开口1129可以在中央开口1127的相对侧设置在中央部1123中。侧壁1111可以从远端端部1107延伸至近端端部1109,但是仅超过它们各自的圆周的大约上半部。纵向凹槽1131可以沿着侧壁1111的外表面设置成容纳切碎器组件1013的外壳1021的对应部。凹槽1131可以包括延伸穿过侧壁1111的第一横向狭槽1133和延伸穿过侧壁1111的第二横向狭槽1135。第一横向狭槽1133可以与远端端部1107隔开一短距离并且可以相对于侧壁1111大致圆周地定向。第二横向狭槽1135可以与近端端部1109和与第一横向狭槽1133隔开一短距离并且可以相对于侧壁1111大致纵向地定向。侧壁1111的内表面可以附加地成形为包括位于第一横向狭槽1133和第二横向狭槽1135之间的块1141。块1141可以成形为在其底部表面上包括外部凹槽1143,凹槽1143平行于第二横向狭槽1135延伸。支架1145可利用一对螺钉1146固定于块1141的底部表面,支架1145可以为由刚性聚合物或金属制成的整体形结构。支架1145可以成形为在其顶部表面上包括凹槽1147,凹槽1147相对于凹槽1143互补地成形,其中,凹槽1143和1147共同地限定大致圆筒形的通道。
驱动组件1015可以附加地包括用于驱动内管状部件1077的转动运动的机构。这种机构可以包括第一马达1151。马达1151又可以包括第一端部1152,该第一端部1152具有从第一端部1152延伸的轴1153。第一端部1152可以容纳在本体1105的远端端部1107的中央部1115内,并且可以利用插入穿过开口1120并且到马达1151的第一端部1152中的互补开口1157内的螺钉1156固定于中内部1115。在马达1151因此固定于远端端部1107的情况下,轴1153可以延伸穿过中央横向开口1119并且可以在中央横向开口1119内自由地转动。电缆1159可以用于将马达1151连接于控制单元1010。
另外,用于驱动内管状部件1077的转动运动的上述机构可进一步包括联接块1161和齿轮1162。联接块1161可以成形为包括远端基部1163和近端杆,联接块1161可以为由刚性聚合物或金属制成的整体形结构,近端杆从基部1163向近端延伸。基部1163可以成形为包括能够从其远端端部进入的腔1164,马达1151的轴1153可以容纳在腔1164内并且利用螺钉1165固定,从而将轴1153机械地联接于块1161。近端杆可以成形为包括增大的直径的远端部1166和减小的直径的近端部1167。齿轮1162可以成形为包括远端管1168和近端带齿的轮1169,齿轮1162可以为由刚性聚合物或金属制成的整体形部件。管1168可以同轴地安装在块1161的部分1166上并且利用螺钉1170机械地联接于块1161的部分1166。轮1169可以安置成使得轮1169的部分延伸穿过狭槽1133以便与轴1051的中间部1057的啮合。以此方式,轮1169的转动引起轴1051的转动。杆1165的近端部1167可位于轴承1173内,杆1165的近端部1167可以向近端延伸超过轮1169一短距离,轴承1173位于由块1141和支架1145共同限定的通道的远端端部内。
驱动组件1015可进一步包括用于驱动内管状部件1077的摆动平移运动的机构。这种机构可以包括第二马达1181。马达1181又可以包括第一端部1182,该第一端部1182具有从其延伸的轴1183。第一端部1182可以容纳在本体1105的近端端部1109的中央部1123内,并且可以利用插入穿过开口1129并且到马达1181的第一端部1182上的互补开口1187内的螺钉1186固定于中央部1123。在马达1181因此固定于近端端部1109的情况下,轴1183可以延伸穿过中央横向开口1127并且可以在中央横向开口1127内自由地转动。电缆1189可用于将马达1181连接于控制单元1010。
另外,用于驱动内管状部件1077的摆动平移运动的上述机构可进一步包括联接块1191、螺纹螺栓1192以及支架1193。联接块1191可以成形为包括近端开口1194和远端开口1195,联接块1191可以为由刚性聚合物或金属制成的整体形结构。近端开口1194的尺寸可以设计成固定地容纳马达1181的轴1183,从而将轴1183机械地联接于块1191。远端开口1195的尺寸可以设计成固定地容纳螺纹螺栓1192的近端端部,从而将螺栓1192机械地联接于块1191。螺栓1192的远端端部可以置于轴承1196内,轴承1196又可以置于由块1141和托架1145共同限定的通道的近端端部内。支架1193可以成形为包括孔1197和一对向上延伸的尖头1198,支架1193可以为由刚性聚合物或金属制成的整体形结构。刚性轴环1199可以利用一对螺钉1200固定地安装在支架1193的孔1197内。轴环1199可以具有内螺纹以接合螺栓1192。以此方式,当螺栓1192转动时,支架1193沿着螺栓1192的纵向轴线平移地移动,其中,支架1193的向近端或向远端平移运动分别由螺栓1192的顺时针或逆时针转动起作用。托架1193可以通过尖头1198机械地联接于轴1051以便平移运动,其中,尖头1198延伸穿过本体1105的狭槽1135并且容纳在切碎器组件1013的狭槽1071-1和1071-2内。
如可以从以上描述中理解的,内管状部件1077转动的速度和内管状部件1077平移摆动的速度被分开地且独立地控制,其中,通过马达1151控制内管状部件1077的转动,并且其中,通过马达1181控制内管状部件1077的摆动平移。
驱动组件1015可进一步包括本体1201。本体1201可成形为包括远端端部1203、近端端部1205、侧壁1207以及腔1208,本体1201可以为由刚性聚合物或金属制成的整体形结构。远端端部1203在形状上可以是大致半圆形,并且近端端部1205在形状上可以是大致半圆形。侧壁1207在横向横截面方面可以是半圆形并且可以从远端端部1203延伸至近端端部1205。在形状上与本体1105的凹槽1131相似的纵向凹槽1209可以沿着侧壁1207的顶部外表面设置成容纳切碎器组件1013的外壳1021的对应部。腔1208的尺寸可以设计成容纳马达1151。一对纵向内腔1213可以设置在本体1201中,内腔1213延伸穿过远端端部1203、近端端部1205以及侧壁1207。内腔1213可以与本体1105中的对应的螺纹腔1215对齐以使本体1201的近端端部1205可以利用插入穿过本体1201并且到腔1215内的螺钉1217固定于本体1105的远端端部1107。
驱动组件1015可进一步包括锁止夹1221。锁止夹1221可以成形为包括基部1223、一对平行支腿1225以及一对平行支脚1227,锁止夹1221可以为由刚性聚合物或金属制成的整体形结构。支腿1225可以从基部1223向上延伸,其中,支腿1225与基部1223的端部向内隔开一短距离。支脚1227可以从支腿1225横向地延伸。基部1223可以容纳在设置在本体1105上的形状匹配的凹部1229内,并且可以通过将本体1201固定于本体1105而固定地保持在凹部1229内。在夹1221因此安装在本体1105上的情况下,支腿1225向上延伸超过本体1105并且可以插入到切碎器组件1013的外壳1021中的对应L形狭槽1230内。以此方式,夹1221可以用于将驱动组件1015可逆地且能够锁定地联接于切碎器组件1013。更具体地,为了将驱动组件1015能够锁定地联接于切碎器组件1013,可以将支脚1227插入到狭槽1230的近端部1230-1内,并且接着可以使支脚1227向远端滑动至狭槽1230的远端部1230-2。为了使驱动组件1015与切碎器组件1013分开,支脚1227可以从远端部1230-2向近端滑动至近端部1230-1并且接着可以从狭槽1230移除。
驱动组件1015可进一步包括本体1231。本体1231可以成形为包括近端端部1233、远端端部1235以及侧壁1237的大致圆筒形的部件,本体1231可以为由刚性聚合物或金属制成的整体形结构。腔1239可以从远端端部1235向近端延伸,腔1239的尺寸设计成基本上容纳整个马达1181,但除了马达1181的第一端部1182和轴1183之外。一对纵向内腔1241可以设置在本体1231中,内腔1241延伸穿过近端端部1233、远端端部1235以及侧壁1237。内腔1241可以与本体1105中的对应螺纹腔1242对齐,以使本体1231的远端端部1235可以利用插入穿过本体1231并且到腔1242内的螺钉1243固定于本体1105的近端端部1109。凹槽1245可以沿着侧壁1237的顶部表面从近端端部1233纵向地延伸至远端端部1235。凹槽1245可以与本体1105的凹槽1131对齐,以容纳切碎器组件1013的外壳1021的对应部。
驱动组件1015可进一步包括端板1251。端板1251可以是成形为在其顶部处包括保持环1253的大致盘形结构,端板1251可以为由刚性聚合物或金属制成的整体形结构。保持环1253的尺寸可以设计成容纳切碎器组件1013的外壳1021的近端端部。一对开口1255可以设置在端板1251中。开口1255可以与本体1231中的对应螺纹腔1257对齐,以使端板1241可以利用插入穿过端板1241并且到腔1257内的螺钉1259固定于本体1231的近端端部1233。
驱动组件1015可进一步包括盖1261。盖1261可以呈现为具有近端端部1263和远端端部1265的半管形状,盖1261可以为由刚性聚合物或金属制成的整体形结构。盖1261的尺寸可以设计成分别补充本体1105的侧壁1111和本体1201的侧壁1207。另外,盖1261可以利用插入穿过盖1261中的开口1269并且到本体1105的近端端部1109中的对应腔1271内的螺钉1267以及利用插入穿过盖1261中的开口1275并且到本体1105的远端端部1107中的对应腔1277内的螺钉1273固定于本体1105。另外,盖1261可以通过利用螺钉1283将盖1261连结于块1281和通过利用一对螺钉1285将块1281连结于本体1201的远端端部1203来固定于本体1201。
现在返回参照图27,真空组件1009可以包括标本收集容器1291和真空源1292。抽空管1293的远端端部可以插入在配件1097上面并且可以通过摩擦配合固定于配件1097,并且抽空管1293的近端端部可以联接于容器1291的第一端口1294。管1295的远端端部可以联接于容器1291的第二端口1296,并且管1295的近端端部可以联接于真空源1292。以此方式,真空源1292可用于将抽吸施加于装置1008,并且被抽吸通过装置1008的任何抽出的组织、液体或类似物可以收集在容器1291中。
控制单元1010可以包括电子设备(未示出),用于利用连接到电缆1159和1189的电缆1298-1控制马达1151和1181的操作。控制单元1010可以利用电源线(未示出)联接于诸如AC壁装电源插座之类的电源。脚踏板1297可以通过电缆1298-2联接于控制单元1010并且可以用作使马达1151和1181选择性地启动或停止的电源开关。控制单元1010可进一步包括真空传感器1299使得可以通过控制单元1010监控容器1291内的压力,真空传感器1299可以通过管1300联接于容器1291。以此方式,真空压力的突然增大可以表示堵塞已经发生。堵塞的出现可以经由位于控制单元1010上的警报器(未示出)来表示。堵塞的检测通常清楚地表示装置1008的进一步操作仅可以使堵塞情形恶化,并且可能必须停止组织移除。控制单元1010可以构造成使驱动组件1015的致动与真空源1292的致动同步。以此方式,打开驱动组件1015将同时打开真空源1292。相应地,无论驱动组件1015何时关闭,真空源1292都可以停止。
在使用时,子宫镜的远端端部可以经子宫颈地插入到病人体内,并且合适的流体可以通过子宫镜的进入流体端口引导到子宫内直到子宫膨胀。接着,可以利用子宫镜的可视化通道执行子宫的观察和子宫肌瘤或其它的异常妇科组织的检测。外管状部件1076和内管状部件1077的远端端部可以通过子宫镜的工作通道插入并且到子宫内,其中,系统1007的其余部分保持靠近子宫镜。接着,装置1008可以操纵成使得外管状部件1076的窗口1089可靠近子宫肌瘤或其它的目标组织安置。然后,真空源1292可以操作成使抽吸施加于内管状部件1077,由此通过窗口1089将组织吸入到外管状部件1076内。另外,马达1151和1181可以操作成使内管状部件1077同时地转动以及在外管状部件1076内平移地来回摆动,从而使通过窗口1089吸取的组织被切割。接着,切割的组织可以借助于上述抽吸通过内管状部件1077从病人体内抽吸出,并且之后收集在容器1291中。一旦子宫肌瘤或其它的目标组织已经因此被从病人体内移除,则真空源1292和马达1151和1181可以被关闭,装置1008可以从子宫镜撤出,并且子宫镜可以从病人体内撤出。接着,切碎器组件1013可以从驱动组件1015卸下并且与真空源1292断开。切碎器组件1013可以设计成一次性使用装置,并且如果这样,可以在病人体内使用之后被处理。相比之下,驱动组件1015可以在其处理之前用在许多不同的病人身上,其中,不同的切碎器组件1013优选地用于每一个病人。
应当注意,虽然以上的讨论考虑通过子宫镜的工作通道插入装置1008,但是可以将装置1008经子宫颈地插入到子宫内而不使用子宫镜。在这种情况下,流体可以通过流体分配装置经子宫颈地分配至子宫以使子宫膨胀,并且此后,可以例如通过利用经子宫颈地插入到子宫内的超声波探针的超声波成像完成子宫的观察。这种超声波探针可以与装置1008分开或可以集成到装置1008中。可替代地,可以通过MRI成像执行子宫的成像。
现在参照图30,示出适合于使用在系统1007中的替代性组织移除装置的局部分解立体图,所述组织移除装置总体以附图标记1450表示。为了简单和清楚起见,装置1450的对本发明的理解不重要的某些方面未在此处示出和描述。
装置1450可以在许多方面与装置1008相似,两个装置之间的主要区别是:装置1008的支架1193和平移联接块1061可以分别以装置1450的支架1461和平移联接块1463代替。装置1450的支架1461可以在许多方面与装置1008的支架1193相似,两个支架之间的主要区别是支架1461可以包括向上偏置的弹簧加载销1465。装置1450的平移联接块1463可以在许多方面与装置1008的平移联接块1061相似,两个块之间的主要区别是(i)平移联接块1463可以成形为包括适合于容纳销1465的腔1467和(ii)平移联接块1463可以成形为包括分别从平移联接块1463的近端端部和远端端部朝向孔1467的开放端部向下倾斜的倾斜表面1469-1和1469-2。在使用时,包括平移联接块1463的切碎器组件可以附接于包括支架1461的驱动组件,并且装置1008的平移马达可以被致动用于使支架1461在一个完整的周期内来回平移地移动。与支架1461和平移联接块1463最初可以相对于彼此平移地安置在何处无关,当支架1461在一个完整的周期内平移地移动时,销1465自动地确保与腔1467对齐。例如,如果销1465最初相对于平移联接块1463在近端安置,当支架1461向远端移动时,销1465的顶部表面行进越过倾斜表面1469-1并且接着容纳在腔1467中。该布置的一个优点是,在切碎器组件和驱动组件附接于彼此时,销1465和腔1467不必相互对齐。如可以理解的,因为切碎器组件可以为一次性物品,然而驱动组件可以是可重复使用物品,所以销1465和腔1467最初可以不相互对齐。
现在参照图31(a)和31(b),示出适合于在系统1007中使用的另一替代性组织移除装置的局部部分分解立体图,所述组织移除装置总体以附图标记1500表示。为了简单和清楚起见,装置1500的对本发明的理解不重要的某些方面未在此处示出和描述。
装置1500可以包括切碎器组件1513和驱动组件1515。切碎器组件1513和驱动组件1515在大多数方面可分别与切碎器组件1013和驱动组件1015相似,各自的切碎器组件和驱动组件之间的主要区别是:切碎器组件1513和驱动组件1515可以借助于设置在切碎器组件1513上的制动器1517和设置在驱动组件1515中的狭槽1519可拆卸地匹配固定于彼此。因此,当希望使用装置1500时,切碎器组件1513的制动器1517优选地插入到驱动组件1515的狭槽1519内,从而将切碎器组件1513和驱动组件1515物理地且操作地联接在一起。接着,可以以上述关于装置1008讨论的相同方式使用装置1500。在已经使用装置1500之后,切碎器组件1513可以例如通过拉动分开它们各自的近端端部直到制动器1517被从狭槽1519移除而与驱动组件1515分开。如果需要,接着,可以处理切碎器组件1513,然而,驱动组件1515可以被再使用。
现在参照图32,示出适合于在系统1007中使用的另一替代性组织移除装置的局部部分分解立体图,所述组织移除装置总体以附图标记1600表示。为了简单和清楚起见,装置1600的对本发明的理解不重要的某些方面未在此处示出和描述。
装置1600可以包括切碎器组件1613和驱动组件1615。切碎器组件1613和驱动组件1615在大多数方面可分别与切碎器组件1013和驱动组件1015相似,各切碎器组件和驱动组件之间的主要区别是:切碎器组件1613和驱动组件1615可借助于靠近切碎器组件1613的远端端部设置在切碎器组件1613上的钩1617和靠近驱动组件1615的远端端部设置在驱动组件1615中的对应狭槽1619可拆卸地固定于彼此。另外,驱动组件1615还可以包括在其近端端部处的弹簧保持部件1621,用于接合切碎器1613的近端端部。因此,当希望使用装置1600时,切碎器组件1613的钩1617优选地插入到驱动组件1615的狭槽1619内,并且接着,弹簧保持部件1621接合切碎器组件1613的近端端部,从而将切碎器组件1613和驱动组件1615物理地且操作地联接在一起。接着,可以以上述关于装置1008讨论的相同方式使用装置1600。在已经使用装置1600之后,切碎器组件1613可以例如通过拉动分开它们各自的近端端部直到钩1617被从狭槽1619移除而与驱动组件1615分开。如果需要,接着,可以处理切碎器组件1613,然而,驱动组件1615可以被再使用。
现在参照图33,示出适合于在系统1007中使用的另一替代性组织移除装置的局部部分分解立体图,所述组织移除装置总体以附图标记1700表示。为了简单和清楚起见,装置1700的对本发明的理解不重要的某些方面未在此处示出和描述。
装置1700可以包括切碎器组件1713和驱动组件1715。切碎器组件1713和驱动组件1715在大多数方面可分别与切碎器组件1013和驱动组件1015相似,各切碎器组件和驱动组件之间的主要区别是:(i)切碎器组件1713可以成形为包括腔1717和(ii)驱动组件1715可以成形为可移除地容纳在切碎器组件1713的腔1717内。(虽然未示出,切碎器组件1713和/或驱动组件1715优选地包括用于使驱动组件1715可释放地保持在腔1717内的机构。)因此,当希望使用装置1700时,驱动组件1715优选地插入到切碎器组件1713的腔1717内直到切碎器组件1713和驱动组件1715物理地且操作地联接于彼此。接着,可以以上述关于装置1008讨论的相同方式使用装置1700。在已经使用装置1700之后,可以将驱动组件1715从切碎器组件1713的腔1717撤出。如果需要,接着,可以处理切碎器组件1713,然而,驱动组件1715可以被再使用。
虽然上面已经在移除病人的子宫内的组织方面讨论了本发明,但是应当理解,可以存在下述情形,其中,可以期望移除子宫肌瘤或位于病人子宫外部或病人体内的其它地方的其它组织。在该情况下,可以期望通过腹腔镜接近目标组织。然而,不幸地,因为组织将不浸泡在液体中而是将被空气简单地包围,所以在这种情况下,不能简单地施加抽吸来将组织吸取到装置的切除窗口中。因此,根据本发明,解决该问题的一个方法是将合适的材料传送至目标组织,在应用抽吸的情况下,该合适的材料则可以用于产生密封以促进目标组织到装置的切除窗口内的吸取。现在参照图34,示出为了这一目的而设计的装置的实施方式,装置总体以附图标记1800表示。装置1800的对本发明的理解不重要的某些方面未在此处示出和描述。
装置1800在某些方面可以与装置6相似。两个装置之间的一个区别是:装置1800可以包括内管状部件1803和外管状部件1805。内管状部件1803和外管状部件1805可分别与装置6的内管状部件77和外管状部件76相似,但是除了(i)外管状部件1805可以包括适合于容纳来自供应件(未示出)的合适的液体或胶体(例如,水、甘氨酸、触变胶体等)的端口1807和(ii)内管状部件1803可以具有比外管状部件1805的内径小大约0.005英寸至0.006英寸的外径(与装置6的大约0.002英寸相对)以允许液体或胶体通过端口1807传送至外管状部件1805以致通过切除窗口1809传送至目标组织。
在图35中示出装置1800的替代性组织移除装置,所述可选择组织移除装置总体以附图标记1900表示。装置1900的对本发明的理解不重要的某些方面未在此处示出和描述。
装置1900在大多数方面可与装置6相似。两个装置之间的主要区别是:尽管装置6可以包括外管状部件76,但是装置1900可以包括外管状部件1903。外管状部件1903可以与外管状部件76相似,除了外管状部件1903可以附加地成形为包括通道1905,该通道1905具有近端输入端口1907和远端输出端口1909。输入端口1907可以适于连接于供应件(未示出),用于合适的液体或胶体(例如,水、甘氨酸、触变胶体等)的容纳。远端端口1909可以安置成靠近切除窗口1911。
以上描述的本发明的实施方式旨在仅是示例性的,在不背离本发明的精神的情况下,本领域技术人员能够对其做出许多改型和改进。所有这些改型和改进旨在落入如在所附权利要求中限定的本发明的范围内。
Claims (18)
1.一种组织移除系统,包括组织移除装置,所述组织移除装置包括:
外壳,所述外壳具有远端端部和近端端部;
外管,所述外管具有近端端部和远端端部,所述外管的所述近端端部联接于所述外壳的所述远端端部并且从所述外壳的所述远端端部向远端延伸,所述外管的所述远端端部的横向表面包括切除窗口;
内管,所述内管设置在所述外管内,所述内管能够相对于所述外管滑动和转动,从而使所述内管的远端端部来回移动经过所述切除窗口,以切断延伸通过所述切除窗口的组织;以及
驱动轴,所述驱动轴以使得所述驱动轴的转动引起所述内管的相应的转动和平移地摆动的方式操作性地联接于所述内管,并且
所述组织移除系统还包括马达驱动组件,所述马达驱动组件包括一马达,所述马达的输出使位于所述马达驱动组件与所述组织移除装置之间的外部驱动轴转动,其中,所述外部驱动轴的远端端部操作性地联接到所述组织移除装置的所述驱动轴,使得所述外部驱动轴的转动引起所述驱动轴的相应的转动,
其中,相应的所述马达驱动组件和所述组织移除装置被构造成使得位于所述马达驱动组件中的所述马达的致动引起所述组织移除装置的所述内管按照不大于0.25的前进比、(i)以至少5000转/分的速度转动并且(ii)以至少1.5周期/秒的速率平移地摆动,所述前进比是所述内管平移地摆动的速度与所述内管转动的速度的比率。
2.如权利要求1所述的组织移除系统,其中,还包括整体形的远端尖端构件,所述远端尖端构件附接于所述内管的远端端部,使得所述远端尖端构件随所述内管一起相对于所述外管平移和转动,其中,所述远端尖端构件的轴向内腔在横截面积上小于所述内管的轴向内腔并且所述远端尖端构件的轴向内腔与所述内管的轴向内腔流体连通,并且其中,所述远端尖端构件的长度大于所述切除窗口的长度。
3.如权利要求1所述的组织移除系统,其中,相应的所述马达驱动组件和所述组织移除装置被构造成使得所述马达的致动引起所述内管以约6000转/分的速度转动。
4.如权利要求1所述的组织移除系统,其中,所述前进比不大于0.15。
5.如权利要求1所述的组织移除系统,其中,相应的所述马达驱动组件和所述组织移除装置被构造成使得所述马达的致动引起所述内管以2.5周期/秒至4周期/秒平移地摆动。
6.如权利要求1所述的组织移除系统,其中,相应的所述马达驱动组件和所述组织移除装置被构造成使得所述马达的致动引起所述内管以约2.8周期/秒平移地摆动。
7.如权利要求1所述的组织移除系统,其中,相应的所述马达驱动组件和所述组织移除装置被构造成使得所述马达的致动引起所述内管以至少1.5gm/min的速率移除组织。
8.如权利要求1所述的组织移除系统,其中,所述外管具有不大于3.0mm的外径。
9.如权利要求1所述的组织移除系统,其中,所述马达驱动组件被构造成使得所述马达的致动与真空源的致动同步,所述真空源在200mmHg至650mmHg的范围内将抽吸施加于所述内管的内腔,由此通过所述切除窗口将组织吸入到所述外管内以被切割,并且将切割的所述组织抽吸通过所述内管的所述内腔。
10.如权利要求9所述的组织移除系统,其中,相应的所述马达驱动组件和所述组织移除装置被构造成使得所述马达和所述真空源的致动引起所述内管以不大于每分钟300cc将流体抽出到所述切除窗口内。
11.一种组织移除装置,包括:
外壳,所述外壳具有远端端部和近端端部;
外管,所述外管具有近端端部和远端端部,所述外管的所述近端端部联接于所述外壳的所述远端端部并且从所述外壳的所述远端端部向远端延伸,所述外管的所述远端端部的横向表面包括切除窗口;
内管,所述内管设置在所述外管内,所述内管能够相对于所述外管滑动和转动,从而使所述内管的远端端部来回移动经过所述切除窗口,以切断延伸通过所述切除窗口的组织;
驱动轴,所述驱动轴设置在所述外壳内,所述驱动轴可转动地联接于外部驱动轴并包括双螺旋凹槽;
支架,所述支架与所述驱动轴接合成使得所述驱动轴相对于所述支架转动,并且所述驱动轴的转动引起所述支架相对于所述驱动轴平移地摆动,其中,所述支架联接到所述内管,使得所述内管与所述支架一起平移地摆动,其中,所述内管平移地摆动的速度取决于所述双螺旋凹槽的结构;
直齿轮,所述直齿轮固定地联接到所述驱动轴;以及
细长的齿轮,所述细长的齿轮固定地联接到所述内管并且与所述直齿轮接合,其中,所述内管转动的速度取决于所述直齿轮与所述细长的齿轮的相对直径,
其中,所述双螺旋凹槽的结构与所述直齿轮和所述细长的齿轮的相对直径被构造成使得所述内管具有不大于0.15的前进比,所述前进比是所述内管平移地摆动的速度与所述内管转动的速度的比率。
12.如权利要求11所述的组织移除装置,其中,所述外管包括不大于3.0mm的外径。
13.如权利要求11所述的组织移除装置,其中,所述内管和所述驱动轴不是同轴的。
14.如权利要求11所述的组织移除系统,其中,还包括整体形的远端尖端构件,所述远端尖端构件附接于所述内管的远端端部,使得所述远端尖端构件随所述内管一起相对于所述外管平移和转动,其中,所述远端尖端构件的轴向内腔在横截面积上小于所述内管的轴向内腔并且所述远端尖端构件的轴向内腔与所述内管的轴向内腔流体连通,并且其中,所述远端尖端构件的长度大于所述切除窗口的长度。
15.一种组织移除装置,包括:
外壳,所述外壳具有远端端部和近端端部;
外管,所述外管具有近端端部和远端端部,所述外管的所述近端端部联接于所述外壳的所述远端端部并且从所述外壳的所述远端端部向远端延伸,所述外管的所述远端端部的横向表面包括切除窗口;
内管,所述内管设置在所述外管内,所述内管能够相对于所述外管滑动和转动,从而使所述内管的远端端部来回移动经过所述切除窗口,以切断延伸通过所述切除窗口的组织;以及
外部驱动轴,所述外部驱动轴通过驱动机构联接到所述内管,其中,所述驱动机构被构造成使得所述外部驱动轴的转动引起所述内管以不大于0.15的前进比相对于所述外管转动和平移地摆动,所述前进比是所述内管平移地摆动的速度与所述内管转动的速度的比率。
16.如权利要求15所述的组织移除装置,其中,所述驱动机构包括:
内部驱动轴,所述内部驱动轴设置在所述外壳内,所述内部驱动轴包括具有双螺旋部的中间部;
支架,所述支架与所述双螺旋部接合成使得所述内部驱动轴相对于所述支架转动,并且所述内部驱动轴的转动引起所述支架相对于所述内部驱动轴平移地摆动,其中,所述支架联接到所述内管,使得所述内管与所述支架一起平移地摆动;
直齿轮,所述直齿轮固定地联接到所述内部驱动轴;以及
细长的齿轮,所述细长的齿轮固定地联接到所述内管并且与所述直齿轮接合。
17.如权利要求16所述的组织移除装置,其中,所述内管和所述内部驱动轴不是同轴的。
18.如权利要求16所述的组织移除装置,其中,还包括整体形的远端尖端构件,所述远端尖端构件附接于所述内管的远端端部,使得所述远端尖端构件随所述内管一起相对于所述外管平移和转动,其中,所述远端尖端构件的轴向内腔在横截面积上小于所述内管的轴向内腔并且所述远端尖端构件的轴向内腔与所述内管的轴向内腔流体连通,并且其中,所述远端尖端构件的长度大于所述切除窗口的长度。
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2010
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- 2010-04-29 ES ES16182254.9T patent/ES2687119T3/es active Active
- 2010-04-29 CN CN201610066887.3A patent/CN105726095A/zh active Pending
- 2010-04-29 CA CA2760328A patent/CA2760328C/en active Active
- 2010-04-29 AU AU2010242907A patent/AU2010242907B2/en active Active
- 2010-04-29 CN CN201080018769.6A patent/CN102438534B/zh active Active
- 2010-04-29 EP EP16182254.9A patent/EP3132760B1/en active Active
- 2010-04-29 EP EP10770377.9A patent/EP2424449B1/en active Active
- 2010-04-29 WO PCT/US2010/033047 patent/WO2010127171A1/en active Application Filing
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US20090270898A1 (en) | 2009-10-29 |
US20090270897A1 (en) | 2009-10-29 |
EP3132760B1 (en) | 2018-06-13 |
EP2424449A1 (en) | 2012-03-07 |
WO2010127171A1 (en) | 2010-11-04 |
ES2687119T3 (es) | 2018-10-23 |
CN105726095A (zh) | 2016-07-06 |
EP2424449A4 (en) | 2015-05-27 |
US8951274B2 (en) | 2015-02-10 |
CA2760328A1 (en) | 2010-11-04 |
CA2760328C (en) | 2017-01-17 |
US20090270895A1 (en) | 2009-10-29 |
AU2010242907A1 (en) | 2011-09-15 |
CN102438534A (zh) | 2012-05-02 |
US20110034943A1 (en) | 2011-02-10 |
WO2010127174A1 (en) | 2010-11-04 |
EP2424449B1 (en) | 2016-11-16 |
ES2615827T3 (es) | 2017-06-08 |
EP3132760A1 (en) | 2017-02-22 |
US20090270812A1 (en) | 2009-10-29 |
AU2010242907B2 (en) | 2015-05-21 |
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