CN102958456B - 用于治疗椎骨骨折的系统 - Google Patents

用于治疗椎骨骨折的系统 Download PDF

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CN102958456B
CN102958456B CN201180032469.8A CN201180032469A CN102958456B CN 102958456 B CN102958456 B CN 102958456B CN 201180032469 A CN201180032469 A CN 201180032469A CN 102958456 B CN102958456 B CN 102958456B
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working end
sleeve pipe
axle
handle
temperature sensing
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CN102958456A (zh
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亚伦·杰曼
约翰·H·沙达克
恰巴·特鲁开
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Dfine Inc
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Abstract

一种移动骨或其他硬组织从而在组织内形成腔的方法和装置。其中,所述方法和装置依靠驱动机构来提供所述装置的移动从而形成改善所述组织移动的剖面。该方法和装置还允许在骨中生成用于插入骨接合剂或其他填充物的路径或腔来治疗骨折或骨中的其他情况。本发明所述的方法和装置的相关特征可以被用于骨或硬组织中的任何区域,其中所述组织或骨被移位以界定孔或腔,而不是在例如钻孔或切除的过程中从体内被取出。

Description

用于治疗椎骨骨折的系统
技术领域
本发明涉及用于在椎骨中生成路径或腔以接收骨接合剂从而治疗椎骨压折的医疗装置和系统。本发明所述的方法和装置的相关特征可以用于骨或硬组织中的任何区域,其中所述组织或骨被移位以界定钻孔或腔,而不是在例如钻孔或切除的过程中从体内被取出。此外,本发明还公开了用于切除或凝固组织的方法和装置,包括但不限于在椎骨和/或皮质骨中切除肿瘤组织。
发明内容
本发明所述的方法和装置涉及在骨或其他硬组织中改进地形成腔,其中所述腔是通过所述组织的移位而形成的。在第一示例中,根据本发明的方法包括治疗椎体或其他骨结构。在一个变型中,该方法包括:提供具有被设置为用于穿入椎骨的锋利尖端的伸长工具,该工具具有从近端延伸到其工作端的轴,其中所述工作端包括至少一个共心地设置于第二套管内的第一套管和一个围绕第二套管共心地设置的第三套管,其中每一个套管包含一系列槽或凹口以限制所述工作端至单一平面内的第一曲线配置的偏移,并且其中,各个系列的槽或凹口在每一个套管内径向偏置;推进所述工作端穿入椎骨;通过在轴向方向上相对于第二套管平移第一套管,将所述工作端从直线配置移动到曲线配置;以及在骨内曲线配置中移动所述工作端以在其中产生一个腔。相对于第二套管平移第一套管可以包括:在轴向方向上移动一个套管或者两个套管。另外的变型包括:在旋转方向上移动一个或两个套管从而在各套管间产生相对轴向位移。
在另外的变型中,本装置包括可以通过机械移动硬组织和/或应用治疗能量切除或凝固组织来治疗硬组织(例如在椎体中)的医疗骨凿装置。例如,一个所述变型包括被连接到电源上的骨凿型装置,并且还包括手柄,所述手柄具有致动部和用于将所述骨凿装置电连接到所述电源上的连接器;所述变型还包括:轴,所述轴包括共心地设置在第二套管内的第一套管,所述轴具有包括工作端的远侧部,所述工作端可以在直线配置和铰接配置间移动,其中,所述铰接配置被限制在单一平面内,并且其中每一个套管包括一系列槽或凹口以限制所述工作端至所述铰接配置的偏移,其中各个系列的槽或凹口在相邻的套管内径向偏置,其中所述轴的第一导电部可电连接到所述电源的第一极;位于所述工作端的第一套管的末端处的锋利尖端,所述锋利尖端适于穿入椎体内的骨中,其中,所述末端可连接到所述电源的第二极,使得当接通时,电流在所述末端的一部分和所述轴之间流动;使第一套管和第一导电部电绝缘的非导电层;并且其中所述轴和锋利尖端具有足够的裂断强度,使得施加在柄上的冲击力引起所述轴的所述远端部和所述末端机械移动所述硬组织。所述电源可以连接到外套管(本发明讨论的第二或第三套管)。
本发明公开的方法的另一个变型可以包括将电极间的能量应用到所述装置上从而切除组织(例如肿瘤)或在组织内执行其他电外科或映像步骤。在一个用于治疗椎体的所述示例中,该方法可以包括提供具有被设置为用于穿入椎骨的锋利尖端的伸长工具,该工具具有从其近端延伸至其工作端的轴,其中所述工作端包括至少一个共心地设置在第二套管内的第一套管,其中,每一个套管包括一系列槽或凹口以限制所述工作端至单一平面内的第一曲线配置的偏移,并且其中各个系列的槽或凹口在相邻的套管内径向偏置,其中第一套管的第一导电部电连接到电源的第一极;推进所述工作端穿入椎骨;通过在轴向方向上相对于第二套管平移第一套管,将所述工作端从直线配置移动到曲线配置;以及使用在第一导电部和电连接到所述电源的第二极的回流电极之间的能量来切除或凝固椎体内的一个区域。
在所述方法的变型中,将所述工作端从直线配置移动到曲线配置可以包括:移动所述工作端,以使其移动穿过多个曲线配置。
在另外的变型中,将所述工作端从直线配置移动到曲线配置可以包括:致动一手柄机构,从而将所述工作端从直线配置移动到曲线配置。如在本发明中所述地,所述手柄机构可以轴向和/或旋转移动。
在一个变型中,致动所述手柄机构,使得所述工作端移动到第一曲线构造而不会扭曲第三套管。
在另外的变型中,所述骨凿或工具的工作端是弹簧偏置的,以呈现所述直线配置。
通过向所述伸长工具施加驱动力或冲击力,所述工作端可以从直线配置移动到曲线配置,其中,穿入皮质骨使得所述工作端从直线配置移动到曲线配置。例如,由于向所述工作端施加了捶打或冲击力,所述锋利尖端紧靠着骨的相互作用使得所述工作端呈现铰接和/或曲线配置。其中,所述工具进一步的轴向运动引起骨压缩并形成了腔。
所述方法还可以包括使用一个或更多个插管来将所述工具引入目标区域。所述插管可以使所述工具保持笔直或直线配置,直到所述工具移出所述插管或直到所述插管从所述工具上缩回。
如上所述,一旦形成所述腔,所述方法还可以包括向所述腔中插入填充材料或其他物质。所述填充材料可以经由所述工具或者经由单独的插管或导管传送。
本发明还包括用于在骨或硬组织中形成腔的装置的变型。所述变型包括用于治疗椎体或其他所述结构的装置。在一个变型中,该装置包括:具有致动部的手柄;轴,其包括共心地设置于第二套管内的第一套管和围绕第二套管共心地设置的第三套管,所述轴具有包括工作端的远端部,所述工作端可以在直线配置和铰接配置间移动,其中第二铰接配置被限制在单一平面内,并且其中每一个套管包括一系列槽或凹口以限制所述工作端至所述铰接配置的偏移,其中各个系列的槽或凹口在每一个套管内径向偏置;以及设置于所述工作端的末端处的尖端,所述尖端适于在椎体内穿入椎骨中。
在一个变型中,本发明所述的装置可以包括在所述工作端将第一套管附着在第二套管上的配置,使得第一套管的近端运动引起所述工作端呈现铰接配置。所述套管可以在其任何部分处经由机械固定装置(例如销或其他固定装置)、粘合剂或一个或多个焊接点沿着其长度而附着。在一些变型中,所述套管的固定发生在工作端,使得内套管或第一套管的运动引起所述工作端呈现曲线配置。在一些情况下,第三套管可以被附着到所述工作端外,只要第一和第二套管铰接,第三套管仍然铰接。
本发明所述的装置可以可选地包括连接在所述致动部和第一套管间的限力组件,使得一旦达到阈值力,所述致动部与第一套管分离。在一个变型中,所述限力机构适于限制当所述工作端从第一配置向着第二配置移动时施加在骨上的力。
在另外的变型中,用于在骨或硬组织中形成腔的装置可以包括一个或多个延伸通过第一套管的弹簧部件,其中所述弹簧部件被附着在所述轴上(在第一、第二或第三套管内或围绕第一、第二或第三套管)。所述弹簧部件在松开的状态下使得所述工作端呈现直线配置。
在另外的变型中,该装置可以包括外套管或第三套管,其中所述槽或凹口(其允许偏移)被设置在第三套管的外表面上。所述外表面典型地是从曲线配置的方向面向外的表面。所述配置允许内表面(位于弯曲部的内侧的表面)是光滑的。因此,如果将所述装置从组织或插管或其他插管器内收回,所述曲线内部的光滑表面最小化了所述装置被卡在插管或其他任何结构的开口处的可能性。
所述装置的变型可以包括一个或多个在所述轴和工作端间延伸的内腔。这些内腔可以在所述装置的末端处或穿过所述装置的壁上的侧开口而退出。所述内腔可以包括包含有光滑聚合材料的表面。例如,所述材料可以包括任何具有低摩擦特性的生物兼容性材料(例如聚四氟乙烯(PTFE)、FEP(氟化乙丙烯)、聚乙烯、聚酰胺,ECTFE(乙烯-三氟氯乙烯共聚物)、ETFE、PVDF、聚氯乙烯和硅树脂)。
如本发明所述地,所述装置可以包括任何数量的配置以防止相邻套管间的旋转,但是允许所述各套管间的轴向运动。例如,所述套管可以经由销/槽或键/键槽配置而机械地连接。在一个另外的变型中,所述套管可以是非圆形的以防止旋转。
在一个另外的变型中,本发明包括各种包含有本发明所述的装置和填充材料(例如骨接合剂或其他骨填充材料)的套件。
上述接入装置和步骤的变型包括各个实施方式的特征或各个实施方式本身的各种可能的组合。
本发明所述的方法、装置和系统可以与以下专利申请和临时申请相结合,其每一个申请的全文通过引用并入本发明中:2008年9月30日提交的美国专利申请61/194,766;2008年10月10日提交的美国专利申请61/104,380;2010年4月8日提交的美国专利申请61/322,281;2009年9月30日提交的美国专利申请12/571,174;2009年9月30日提交的PCT申请PCT/US2009/059113;2009年10月13日提交的美国申请12/578,455。
附图说明
图1是本发明的骨凿的平面图。
图2是图1的骨凿的侧视图。
图3是图1的骨凿的截面图。
图4是图1的骨凿的手柄的放大截面图。
图5是图1的骨凿的工作端的放大截面图。
图6A是图5的工作端在直线配置中的截面图。
图6B是图5的工作端在曲线配置中的截面图。
图7A-7C是使用图1的骨凿的方法的示意性截面图。
图8是骨凿工作端的另一个实施方式。
图9是骨凿工作端的另一个实施方式。
图10是具有外套管的骨凿的另一个变型。
图11是图10的骨凿的工作端的剖视图。
图12A是工作端的另一个实施方式沿图11中12A-12A线的截面图。
图12B和12C例示了防止相邻套管间旋转的另外的变型。
图13是与图11中工作端相似的另一个工作端的实施方式的截面图。
图14是图13的工作端的剖视透视图。
图15例示了本发明所述的骨凿的一个变型,所述骨凿在所述装置的尖端上具有电极并且在所述轴上具有另外的电极。
图16例示了如在图15中所示的骨凿装置在被推进入椎体后的状态且电流在电极间流动。
图17例示了本发明所述装置的一个变型,其还包括用于在所述装置的工作端提供能量的连接器。
图18A和18B例示了具有如本发明所述的锋利尖端的装置,其中所述锋利尖端可从轴的远端推进。
图19例示了如在图18B中所示装置的截面图并且还例示了设置在装置上的温度传感部件。
图20例示了装置的一个变型,其中内套管从所述装置延伸,并且其中在内套管的延伸部和所述轴之间施加电流以治疗组织。
图21例示了如本发明所述装置的一个变型,其还包括由所述装置的工作端携带的可延伸的螺旋电极。
图22A和22B例示了图21的装置,其具有在非延伸位置和延伸位置中的螺旋电极。
图23例示了图21的装置在椎体内的工作端,所述工作端具有将RF能量传送给组织的螺旋电极,以用于切除或其他治疗。
图24例示了可替换的铰接式切除装置,其包括工作端,所述工作端包括在铰接式工作端的外半径上的具有相反极性的电极表面。
图25例示了图24中的铰接式工作端,其向椎体内的组织释放RF能量,其中,一绝缘表面从椎管处引导能量。
图26例示了可替换的铰接式装置,其具有工作端,所述工作端包括从铰接式工作端的外半径延伸的多个可延伸电极。
图27例示了图26中的铰接式工作端,其在椎体中向组织施加RF能量,其中,多个延伸电极从椎管处引导能量。
图28例示了可替换的铰接式切除装置,其具有工作端,所述工作端包括具有相反极性的电极表面以及可连接至装置中内腔的绝缘流体媒质或胶质。
图29例示了图28中的铰接式工作端,其在椎体中向组织施加能量,其中,绝缘胶质从椎管处引导能量。
具体实施方式
参照图1-5,示出了装置或骨凿100,其被配置为进入椎体的内部,并且在椎骨的松质骨中形成路径来接收骨接合剂。在一个实施方式中,所述装置被配置为具有延伸部或构件105,以用于引导穿过椎弓根,并且其中延伸构件105的工作端110可以被逐步地致动,以弯曲成选择的角度和/或旋转,从而在椎体中线的方向上形成弯曲的路径和腔。所述装置可以被收回并且骨填充材料可以被引导穿过骨接合剂注射插管。可选地,随着之后穿过所述装置的内腔112而注射接合剂,所述装置100自身可以被用作接合剂注射器。
在一个实施方式中,所述装置100包括被连接到所述延伸构件105的近端的手柄115。所述延伸构件105包括第一(外)套管120和第二(内)套管122的组件,且第一套管120具有近端124和远端126。第二套管122具有近端134和远端136。如下面将描述地,所述延伸构件105被连接到所述手柄115,以允许医生驱动所述延伸构件105进入骨内且同时致动所述工作端110进入铰接或曲线配置(见图6)。所述手柄115可以由聚合物、金属或任何其他适合经受用于驱动所述组件进入骨中(例如,经由在所述手柄115上使用锤子或相似的装置)的捶打或冲击力的材料制造。所述内套管和外套管由适合的金属合金制造,例如不锈钢或NiTi。所述内套管和外套管的壁厚在约0.005”至0.010”的范围内且所述外套管的外直径在约2.5毫米至5.0毫米的范围内。
参照图1、3和4,所述手柄115包括第一握持部140和表示为142的第二致动部。如下面将描述地,所述握持部140被连接到第一套管120。如下面将描述地,所述致动部142被可操作地连接到第二套管122。所述致动部142可相对于所述握持部140旋转,并且所述握持部140的一个或多个塑料弯曲片145被配置为使凹口146啮合在旋转的致动部142中,从而提供触觉指示并将所述柄部140和142临时锁定在特定旋转角度中。因此所述弯曲片145与所述凹口146啮合或脱离,从而允许所述手柄部和连接在其上的各个套管的棘轮作用(旋转和锁定)。
在任一套管中的槽或凹口可包括沿着所述工作端长度的均匀宽度或变化宽度。可选地,可以在某一区域内选择所述宽度以实现特定的弯曲轮廓。在其他变型中,所述宽度可以沿工作端增加或减少从而形成具有变化半径的曲线。很明显,应理解的是,任何数量的变型都落入本发明的范围之内。
图4是手柄的截面图,其示出了用于相对于第一外套管120致动第二内套管122的机构。所述手柄115的所述致动部142被配置为表示为150的、与所述手柄的握持部140上的突出螺纹149配合的快锁螺旋槽。因此,可以理解的是,所述致动部142的旋转将移动该部到表示为150(透视图)的位置处。在一个实施方式中,当所述致动部142是以选定的、从约45°至720°或从约90°至360°的量旋转时,内套管122近似相对于所述握持部140和外套管120被提升,从而致动所述工作端110。从图4中可以看出,所述致动部142与被焊接到内套管122的近端132的凸缘152啮合。所述凸缘152通过设置于凸缘152和插入所述手柄的握持部140内的金属轴承表面155之间的球轴承组件154被提升。因此,致动部142的旋转可以提升内套管122而不会在所述内套管上引起扭曲。
现在参照图5、6A和6B,可以看出,通过都可以在很小的半径内弯曲的、外套管120与内套管122的远端部的开槽部的配合,所述延伸构件105的工作端110被铰接。外套管120内具有多个槽或凹口162,其可以相对于套管的轴垂直或成角度。内套管122具有多个表示为164的槽或凹口,其可以位于组件相对于外套管120内槽162的相对侧。外套管和内套管在被表示为焊点160的远侧区域焊接在一起。因此可以理解的是,当内套管122在近端方向上平移时,外套管将如图6B所示被弯曲。可以理解的是,通过以选择的量旋转所述致动手柄部142,所述工作端可以被铰接到选定的角度。
图4、5、6A和6B还例示了所述装置的其他部件,其包括具有近端171和凸缘172的弹性扁线构件170,其中该凸缘172与内筒122的凸缘152的近侧相啮合。至少所述扁线构件170的远端部174在焊点175处被焊接到内套管。所述扁线构件由此提供了安全特性,以在所述内套管的一个槽164失灵时保持所述工作端。
所述装置的另一个安全特性包括扭矩限制器和释放系统,该释放系统允许整个手柄组件115自由旋转——例如,如图6B所示,如果当医生旋转手柄并且当所述工作端啮合在坚固的松质骨中时所述工作端110是铰接的。参照图4,所述手柄115的握持部142与被固定到外套管120的近端124的衬圈180相啮合。所述衬圈180还包括凹口185,各凹口185由该衬圈180径向地间隔开并且与球构件186啮合,该球构件186被弹簧188推入凹口185中。以选择的力,例如在大于约0.5英寸磅但小于约7.5英寸磅、5.0英寸磅或2.5英寸磅的范围内的扭矩,所述手柄115的旋转克服了预定的限制。当扭矩限制器组件处于其锁定位置时,所述球轴承186受迫进入衬圈180中的一个凹口185内。当过多的扭矩被施加到手柄和外套管上时,所述球轴承186与凹口185脱离,这使得衬圈180转动,然后球轴承186在下一个凹口处再次啮合,释放在从0.5英寸磅至7.5英寸磅的范围内的扭矩。
参照图6A和6B,可以理解的是,内套管122在其远端部的一侧上被弱化,使得内套管122在任意方向上弯曲,但受限于凹口在外套管120中的位置。任一铰接配置的曲率是由凹口的间距和各个凹口的顶部的间距控制的。所述内套管122也具有用于穿入椎体的皮质骨中的带斜面的尖端。内套管或者外套管中任意一个都可以形成所述末端。
参照图7A-7C,在所述装置的使用的一个变型中,医生轻敲或以其他方式驱动探针200和插管器套管205进入椎体206,典型地直到探针尖端208进入向着皮质骨210的椎体前部的1/3处(图7A)。此后,所述探针200被移除并且套管205向近端移动(图7B)。从图7B中可以看出,所述工具或骨凿100是穿过插管器套管205插入的,并且在一系列如上所述的步骤中是铰接的。当施加驱动力、并且可选地施加旋转力到手柄115上以推进所述工作端穿过松质骨212来形成路径或腔215时,所述工作端110可以是间歇性地铰接的。然后轻敲所述工具来进一步驱动所述工作端110使其到达、朝向或越过椎骨的中线。可选地,医生可以铰接所述工作端110,并且进一步驱动和旋转所述工作端,直到图像显示出工作端100已经形成具有最佳配置的腔215。此后,如图7C所示,随着延伸构件已从椎体206中被收回,医生颠倒顺序并且逐步地伸直所述工作端110。然后,医生可以将骨接合剂注射器220插入到由骨凿100形成的路径或腔215中。图7C例示了正由骨接合剂源225注射诸如PMMA接合剂的骨接合剂222。
在另外的实施方式中(未示出),所述装置100可以具有手柄115,该手柄具有用于连接骨接合剂注射器的鲁尔接头配件,并且所述骨接合剂可以经由所述装置的内腔112注射。在图9的实施方式中,所述内腔可以具有光滑的表面层或聚合物衬里250,从而当骨接合剂流经腔时确保对骨接合剂的最小阻力。在一个实施方式中,所述表面或衬里250可以是氟化聚合物,例如或聚四氟乙烯(PTFE)。可以使用其他合适的氟聚合物树脂,例如FEP和PFA。也可以使用其他材料,例如FEP(氟化乙丙烯)、ECTFE(乙烯-三氟氯-乙烯共聚物)、ETFE、聚乙烯、聚酰胺、PVDF、聚氯乙烯和硅树脂。本发明的范围可以包括提供具有小于0.5、小于0.2或小于0.1的静态摩擦系数的聚合材料。
图9还示出了可被配置为具有表示为255的外部柔性套管的延伸构件或轴105。所述柔性套管可以是公知的生物兼容性材料,例如,所述套管可以包括前一段所述的任何材料。
从图9中还可以看出,在所述装置100的一个变型中,所述工作端110可以被配置为:在表示为260的长度上,基本上以光滑的曲线弯曲。所述工作端100的铰接度可以是至少45°、90°、135°或如265所示的为至少180°(图9)。在另外的变型中,外套管120和内套管120的槽可以改变,从而生产具有在所述装置100的长度260内变化的曲率半径的装置。
在本发明的其他实施方式中,内套管可相对于外套管被弹簧加载,以这样的方式,允许在直线方向上以选定程度的力拉伸工作端时使所述工作端伸直。这个特征允许医生从椎体部分地或整体地收回所述组件而无需进一步旋转手柄115的致动部142。在一些变型中,可以使用限力器,从而允许将小于约10英寸磅的力施加到骨上。
在图8所示的其他实施方式中,所述工作端110配置有尖端240,在被驱动进入骨中时,该尖端240偏转到表示为240’的位置处。所述尖端240通过弹性构件242被连接到套管组件,弹性构件242为例如诸如不锈钢或NiTi的弹性金属。已经发现,所述尖端240的弯曲引起其远端表面区域与松质骨啮合,从而协助工作端110在被锤入骨中时偏转。
在本发明的另一个实施方式中(未示出),致动手柄可以包括用于致动工作端的次级(或可选)机构。该机构可以包括具有棘轮的可捶打构件,使得锤的每一次轻敲都可以推进组件并且逐步地驱使工作端进入曲线配置。本领域中已知的棘轮机构可以将所述组件保持在多个铰接配置中的每一个配置中。为了伸直所述延伸构件105从而将其从所述椎体中撤出,可以释放所述棘轮。
图10和11例示了骨治疗装置400的另一个变型,其具有手柄402和延伸到工作端410的延伸构件405,与图1至6B中的具有相似构造。如上所述地,使用第一(外)凹口套管120和相配合的第二(内)凹口套管122来操作所述装置400。但是,在图10和11中所示的变型还包括位于第一套管120和第二套管122外的、同轴的第三凹口套管420。如在图11中以265所表示的,在工作端410处的套管420中的槽或凹口允许套管偏转。
图10还示出了治疗装置400,其包括鲁尔接头配件412,该鲁尔接头配件允许装置402被连接到填充材料源(例如骨填充物或骨接合剂材料)。所述鲁尔接头可以从手柄402移动,从而允许如上所述地向手柄上施加冲击力。此外,所述鲁尔接头配件402可以设置在手柄的致动部上、手柄的固定部上或甚至沿着套管设置。在任何情况下,所述装置400的变型允许将填充材料与延伸通过套管(或在相邻的套管间延伸)的内腔连接,从而在工作端410沉积填充材料。如箭头416所示,填充材料可以经由套管的远端沉积(其中,锋利尖端是坚固的)或经由套管侧壁的开口沉积。很明显地,所述配置的变型落入本领域技术人员公知的范围内。
在一些变型中,第三凹口套管420配置有平滑(无凹口)表面424,该表面面向内部地设置在铰接式工作端(图11)上,使得固体表面形成工作端410的弯曲部的内部。所述平滑表面424允许收回伸入到插管或插管器205内部的装置110而不会造成使槽或凹口被卡在插管205内的风险(参见例如图7B)。
如图10-11所示,第三(最外侧)套管420可以从延伸构件405的中间位置延伸到工作端410的远端。但是,所述装置的变型包括延伸到手柄402处的第三套管420。但是第三套管420典型地不连接到手柄402,使得由手柄402产生的任何旋转力或扭矩都不会直接被传送给第三套管420。
在一个变型中,第三套管420只在一个轴向位置上被连接到第二套管120。在图11例示的示例中,第三套管420在工作端410的远端处通过焊点428附着到第二套管420。但是所述焊点或其他附着工具(例如,销、键/键槽、突起等)可以设置在套管420的中间部分上。所述套管420可以由任何生物兼容性材料制造。例如,在一个变型中,第三套管是由直径为3.00毫米且壁厚为0.007”的不锈钢材料制成。第一、第二和第三套管的尺寸允许各套管间的滑动配合。
图12A是延伸构件405的与图10-11中例示的相似的另一个变型的截面图。但是,由图12A例示的变型包括同轴的可滑动套管(两个或三个套管装置)的非圆形配置。所述配置限制了或防止了各套管间的旋转,并且允许医生向骨施加更大的力以形成腔。虽然图12A例示了椭圆形配置,但任何非圆形的形状都落入本发明的范围之内。例如,如图12B和12C所示,横截面的形状可以包括正方形、多边形或其他径向键配置。如图12C所示,所述套管可包括键407和接收键槽409,以防止套管的旋转,但是允许各套管的相对或轴向滑动。所述键可以包括在接收键槽内滑动的任何突起或构件。另外,在各个套管的外部或内部,所述键可以包括销或任何凸出的突起。在这个示例中,只例示了第一套管122和第二套管120。但是,任何套管都可配置有键/键槽。防止套管间的旋转提升了向铰接式工作端处的骨施加力的能力。
图13-14例示了骨凿装置工作端410的另一个变型。在这个变型中,所述工作端410包括一个或多个平板弹簧部件450、460a、460b、460c、460d,以阻止所述组件的各套管间的相对旋转,从而允许从铰接式工作端向松质骨施加更大的旋转力。所述弹簧部件还迫使工作端组件进入直线配置。为了铰接套管,如上所述地向手柄施加旋转力,一旦旋转力撤除,所述弹簧部件迫使工作端进入直线配置。如图13所示,一个或多个所述弹簧部件可以延伸通过所述套管,从而附着到手柄上以防止旋转。此外,平板弹簧部件450的远端454通过焊点455固定到套管组件上。因此,弹簧部件在每一端部上被固定,从而防止其旋转。可选的变型包括一个或多个在套管的中部处附着到内套管组件上的弹簧部件。
如图13-14所示,骨凿的变型可以包括任何数量的弹簧部件460a-460d。所述另外的弹簧部件460a-460d可以在其近端或远端中的任一端处被焊接到相邻的部件或套管上,从而允许所述部件充当片簧。
在另外的变型中,如图15所示,骨凿装置可以包括一个或多个电极310、312。在所述具体示例中,所述装置300包括间隔开的具有相反的极性的电极,从而以双极方式运行。但是,所述装置可以包括单极配置。此外,一个或多个电极可以被连接到电源的单独通路上,使得电极可以根据需要被通电。上述装置的任何变型都可以配置有一个或多个本发明的中所述的电极。
图16例示了如上所述地被推入到体内之后的骨凿装置300。如线315所例示的,电流在电极间流动,当需要时,医生可以在电极310和312之间实施RF电流,从而在椎体(或其他硬组织)的骨结构内施加凝固或切除能量。虽然图16例示了RF电流315在电极310和312之间流动,所述装置的变型可以包括沿着所述装置的多个电极,从而提供合适的治疗能量。此外,电极可以与骨凿的一端间隔开,而不是如电极310所示地设置在锋利尖端上。在一些变型中,电源被连接到锋利尖端的内部或第一套管的其他工作端。在只具有两个套管的变型中,电源的第二极被连接到第二套管(即所述装置的外部),以形成回流电极。但是,在具有三个套管的变型中,可选地,电源可以被连接到第三外套管。在另外的变型中,第二和第三套管都可以充当回流电极。但是,在那些单极的装置中,所述回流电极将被放置在体外大面积的皮肤上。
图17至20例示了铰接式探针或骨凿装置500的另一个变型。在所述变型中,所述装置500包括工作端505,该工作端携带有一个或多个可以被用于引导电流从其穿过的RF电极。因此,所述装置可以被用于感应组织的阻抗、定位神经或简单地向组织施加电外科能量来凝固或切除组织。在一种可能的应用中,所述装置500可以向肿瘤或脊骨中的其他组织提供切除能量以及形成腔。
图17、18A、18B和19例示了装置500的变型,其具有连接到轴组件510的手柄部506,所述轴组件510沿着轴512延伸到铰接式工作端505。所述铰接式工作端505可以是如上所述地可致动的。另外,图17示出了手柄部件514a可以相对于手柄部件514b旋转,从而引起在第一外套管520和第二内套管522(图19)之间的相对轴向运动,从而引起套管组件的开槽的工作端如上所述地铰接。图19的工作端505示出了两个套管520和522,其是可致动的,从而铰接所述工作端,但是应理解的是,如上所述,可以增加第三外铰接套管。在一个变型中,通过在1/4转和3/4转之间旋转手柄部件514a,可以以90°铰接所述铰接式工作端。所述旋转中的手柄部件514a可包括在不同旋转位置中的棘爪,从而将工作端受控地锤入骨中。例如,所述棘爪可以设置在每旋转45°的位置处或者可设置在其他任何旋转增量处。
图17例示了RF生成器530A和RF控制器530B,其可通过表示为536的插塞式连接器连接到手柄部件514a中的电连接器532。所述RF生成器是电外科切除领域中的已知类型。外套管520包括表示为540A(+)的第一极性电极。但是,本装置可以采用任何能量形态。
图18A和18B还例示了用于在硬组织中形成腔的装置的工作端的另一个变型。如例示地,装置500可以包括中心可延伸套管550,其具有可从第一和第二套管520和522(图19)的组件的通道554轴向延伸的锋利尖端552。所述套管550还可以包括表示为540B(-)的第二极性电极。很明显地,第一和第二电极彼此间将是电绝缘的。在一个变型中,并且如图19所示,所述套管组件可以携带有薄套管555或例如PEEK的绝缘聚合物涂层,以使得第一极性电极540A(+)与第二极性电极540B(-)电绝缘。可通过旋转所述手柄部件514a(图17)的承击面上的按钮558而展开所述电极。中心套管550的延伸度数可以可选地由手柄上的滑片557表示。在例示的变型中,所述滑片设置在手柄部件514a(图17)的任意一侧上。套管550可以被配置为向远侧延伸,越过套管组件520和522约5至15毫米的距离。
参照图19,所述中心可延伸套管550可以在至少一个其远端部处具有一系列槽,以允许其与第一和第二套管520和522的组件相配合而弯曲。在图18B所示的实施方式中,所述中心套管550可以可选择地包括远端部,该远端部不包含任何槽。但是,另外的变型在套管的远端部处包括槽。
图19还例示了电绝缘衬圈560,其延伸长度A,从而轴向地分隔第一极性电极540A(+)和第二极性电极540B(-)。所述轴向长度A可以是约0.5至10毫米,并且通常是1至5毫米。所述衬圈可以是陶瓷或耐温聚合物。
图19还例示了在电极套管550的中心的内腔内延伸的聚合物套管565。所述聚合物套管565可以向工作端提供盐水滴注或其他流体和/或可被用于在使用中从工作端吸气。所述套管550的远端部中可以包括一个或多个端口566,以用于从所述位置传送流体或吸气。
在所有其他方面中,骨凿系统500可以被驱动进入骨中并且如上所述地被铰接。如本领域公知地,电极540A和540B被可操作地连接到射频生成器,从而向组织提供凝固或切除用的电外科能量。从图20中可以看出,如线575所示地,RF电流575例示在电极540A和540B间的路径中,表示为线575。与本发明所述装置一起使用的RF生成器530A和控制器530B可以包括任何数量的电源设置,从而控制定向凝固或定向切除区域的大小。例如,所述RF生成器和控制器可以具有低(5瓦特)、中(15瓦特)和高(25瓦特)功率设置。所述控制器530B可以具有控制算法,其监视电极的温度并且改变电源输入,从而保持恒定的温度。至少一个温度传感部件(例如热电偶)可以被设置在所述装置的不同部件上。例如,如图19所示,温度传感部件577可以被设置在套管550的尖端的末端处,而第二温度传感部件578可以设置在末端的近端处,从而在使用RF能量的过程中向操作者提供温度反馈来表示被切除的组织的区域。在一个示例中,第二温度传感部件被设置在距离所述末端约15至20毫米的位置。
图21例示了具有RF切除特征的铰接式骨凿600的另一个变型。所例示的骨凿600的变型可以类似于图17-18B的骨凿。在这个变型中,骨凿600可以如上所述地具有被连接到轴组件610的手柄602。所述工作端610仍然具有在图21中表示为615的可延伸组件,其可以通过相对于柄602旋转手柄部622而延伸。所述骨凿可以如上所述地通过相对于手柄602旋转手柄部620而被铰接。
图22A-22B是图21的工作端610在第一非延伸配置(图22A)和第二延伸配置(图22B)中的视图。从图22A-22B中可以看出,延伸部615包括轴向轴624和可轴向收缩或伸展的螺旋弹簧部件625。在一个实施方式中,所述轴可以是管构件,其具有流动地连接到内腔628中的端口626。在一些变型中,所述端口可将流体携带到工作端或可从工作端抽吸流体。
在图22A-22B中,可以看出,轴向轴624、螺旋弹簧部件625和锋利尖端630一起包括如上所述的第一极性电极(+),其连接到电源530A和控制器530B。绝缘体632将所述螺旋弹簧电极625与更多包括相反极性电极640(-)的套管的近端部间隔开。RF电极可以如上所述(参见图20)地用来切除组织或向组织传送能量。
在一个变型中,延伸部615可以从2毫米、3毫米、4毫米或5毫米的弹簧压缩长度延伸到6毫米、7毫米、8毫米、9毫米10毫米或更长的弹簧拉伸长度。在图22B的工作端实施方式615中,所述弹簧可以包括扁平矩形线,其协助将弹簧625围绕轴624共心设置,但通过使矩形线的扁平表面定向为堆叠状,仍可以将整个长度压缩至很短。但是,其他变型也落入本发明所述变型的范围之内。
使用弹簧625作为电极显著地改善了能量传送。所述弹簧(i)显著增加了电极表面积且(ii)非常显著地增加了由提供了边缘的矩形线所提供的相对尖锐的边缘的长度。因为所述边缘提供了小的表面积,RF电流的密度或强度在边缘处更大,并且允许RF电流跃变或形成电弧。本发明的这两个方面——增加的电极表面积和增加的电极边缘长度——都允许更快地切除组织。
在本发明的一个方面中,在上述弹簧电极的长度上,弹簧电极625的表面积可以是至少40平方毫米,至少50平方毫米,或至少60平方毫米。
在本发明的另一方面中,在上述弹簧电极的长度上,矩形钢丝弹簧的4个边缘的总长度可以大于50毫米、大于100毫米或大于150毫米。
在用于测试的一个示例中,骨凿600(如图21-22B所示)配置有压缩长度为1.8毫米且拉伸长度为7.5毫米的螺旋弹簧。在所述实施方式中,当拉伸时,弹簧电极625的表面积是64.24平方毫米并且电极边缘的总长度是171.52毫米(4个边缘,每个长42.88毫米)。
如图22B所示,在对比测试中,将不具有螺旋电极的第一骨凿与具有螺旋电极的第二骨凿600进行对比。所述装置在不同的功率水平和不同的能量传送间隔下被评估,以确定切除量。除了螺旋弹簧电极外,这些装置的工作端具有相似的尺寸。在下表A中,RF能量是在5瓦特的低功率设置下被传送的。从表A中可以看出,在120秒的治疗间隔和5W的功率下,具有螺旋电极的工作端的切除量是不具有螺旋电极的工作端的切除量的3倍快(1.29cc比.44cc)。
表A(5W)
表B(15W)
在高于15瓦特的功率水平下评估相同的第一骨凿500(图18B)和具有螺旋电极(图22B)的第二骨凿600的另一个对比测试。从表B可以看出,在25秒的治疗间隔和15W功率的RF能量下,具有螺旋电极的工作端的切除量又是不具有螺旋电极的工作端的切除量的3倍快(1.00cc比0.37cc)。在表B中,不具有螺旋电极的装置在60秒结束前受阻,所以无法提供数据。测试显示,螺旋电极非常适合切除任何类型的组织或肿瘤,在60秒的时间内可以切除1.63cc的组织。
图23示意性地例示了在椎体中使用骨凿600,其中,电极625和640之间的RF电流切除了表示为640的组织。
图24例示了铰接式骨凿700的另一个变型,该铰接式骨凿700具有提供RF能量的能力。所述装置的一些变型可被制备为与图17-18B中的骨凿类似。在一个变型中,轴组件705类似于先前示例,其中,工作端710携带有可延伸部件725,该可延伸部件725携带有在图24中表示为727的电极表面。可延伸部件725可通过设置在轴组件705中的内腔中的柔性套管722的延伸而致动。例如,所述柔性套管722和可延伸部件725可通过旋转如上所述的手柄机构而延伸。如前所述地,可通过相对于第二手柄部分旋转第一手柄部分来铰接所述骨凿。
仍参考图24,可延伸电极727可被连接至电源530A的第一极,且轴725可包括具有相反极性的电极表面740,该电极表面740连接至电源530A第二极。一绝缘体衬圈分隔第一和第二极性电极表面727和740。在一些变型中,所述衬圈携带有绝缘涂层或由绝缘材料制备。如图24中所见,可延伸部件725的面向后部的表面携带有电绝缘体744,该电绝缘体744包括但不限于油漆、涂层、磁带、聚合物、陶瓷等。进一步地,铰接轴705的内部半径携带有电绝缘体745,该电绝缘体745也可为油漆、涂层、磁带、聚合体部件、陶瓷等。
图25例示了图24中的铰接式工作端,其在椎体中向组织释放RF能量,其中绝缘表面744和745在装置的相对侧上引导对组织的加热,使得能量从椎管748导出。在一些变型中,所述能量是在表示为750的切除区域处产生的。然而,不论是切除还是不切除,本发明所描述的装置包括任何种类的能量传递。
图26例示了具有RF切除功能的铰接式骨凿800的另一实施方式。在一实施方式中,轴组件805类似于先前具有工作端810的实施例,该工作端810携带有多个可延伸电极825,该多个可延伸电极825可通过手柄中的致动机构而延伸。如前所述地,通过相对于第二手柄部分旋转第一手柄部分来铰接所述骨凿。可延伸电极825与轴电极840如前所述地相配合,并通过绝缘套管832与轴电极840分离。图26中的实施方式进一步在轴的内部半径上携带有轴向延伸的绝缘体845。
总的来说,图26的骨凿800包括:手柄,其具有用于将装置电连接至电源的连接器;轴805,其具有从手柄延伸至工作端810的轴线,其中,所述轴的第一导电部可电连接至RF电源的第一极;多个可延伸电极部件825,其可从所述轴延伸,其中,所述可延伸部件825可连接至电源的第二极,使得在接通时,电流在可延伸部件和轴之间流动,以及其中,所述可延伸部件相对于轴805的轴线径向不对称。
图27例示了图26中的铰接式工作端,其在椎体中向组织施加能量,其中,多个延伸电极825在与椎管748间隔开的区域850中传递能量。
图28例示了具有RF切除功能的可替换的铰接式切除装置900。在一实施方式中,轴或延伸部件905包括两个组件。一个组件910可为前述实施方式中的铰接式组件或可为NiTi套管,其延伸至工作端910并携带有可延伸电极925,可通过手柄中的致动机构来延伸所述可延伸电极925。所述延伸部件的第二组件930包括柔性聚合物套管或者NiTi套管,其内具有内腔,所述内腔用于将流体媒质携带至工作端910中的出口932。电极925和940如前所述地起作用。
图28的实施方式包括电绝缘和/或热绝缘的胶质流体965的源960,可在组织部位中注射胶质流体965,从而保护选定的组织不被切除。总的来说,本发明的骨凿包括:手柄,其具有用于将骨凿装置电连接至电源的连接器;轴,其从手柄延伸至工作端,其中,所述轴的第一和第二导电部分可连接至电源的第一和第二极,并且所述轴中的内腔可连接至绝缘的可流动媒质源。
图29例示了图28中的铰接式工作端,其在椎体中施加RF能量以切除组织,其中,注射绝缘胶质以保护椎管748,进而生成远离椎管的切除区域950。
尽管以上详细描述了本发明的具体实施方式,但应理解的是,本说明书仅出于例示的目的且本发明的上述说明并不详尽。仅出于方便,本发明的具体特征在一些图中示出而没有在其他图中示出,并且任何特征都可以和根据本发明的其他特征相结合。对于本领域的技术人员来说明显的是,可以做出多种变型和改变,所述改变和变型旨在落入本发明权利要求的范围之内。独立权利要求例示的具体特征可以被组合并且也落入本发明的范围之内。本发明还包括参照其他独立权利要求而可选地以多项从属权利要求形式撰写的从属权利要求的实施方式。

Claims (13)

1.一种用于治疗硬组织的医疗装置,该装置包括:
手柄,其具有用于电连接到电源的连接器;
轴,其从所述手柄延伸至工作端,其中,所述轴的第一导电部可电连接到所述电源的第一极;以及
可延伸部件,其可从所述轴延伸;
其中,所述可延伸部件可连接到所述电源的第二极,使得当接通时,电流在所述可延伸部件和所述轴之间流动;其中,所述轴的所述工作端被配置为在单独的平面内铰接从而形成铰接配置;
致动机构可操作地连接至所述手柄,所述致动机构被配置为使所述工作端变形为并保持在所述铰接配置,其中所述工作端被配置为在施加驱动力时保持在铰接配置使得工作端的铰接配置创建空腔;以及
其中,所述工作端的轴向延伸表面部分包括电绝缘体,从而控制电流流动,并在所述装置相对所述电绝缘体的一侧上引导对组织的加热。
2.根据权利要求1所述的医疗装置,其中,可延伸部件包括轴向延伸表面部分,所述轴向延伸表面部分包括所述电绝缘体。
3.根据权利要求1-2中任一项所述的医疗装置,其中,所述电绝缘体设置在所述铰接形状的内部半径上。
4.根据权利要求1-2中任一项所述的医疗装置,其中,所述手柄被配置为接收冲击力从而使所述工作端穿入骨中。
5.根据权利要求1-2中任一项所述的医疗装置,该装置还包括内腔,其位于所述轴内且可连接至绝缘可流动媒质的源。
6.根据权利要求5所述的医疗装置,其中,所述绝缘可流动媒质包括电绝缘体或热绝缘体或胶质。
7.根据权利要求1所述的医疗装置,该装置还包括至少一个温度传感部件。
8.根据权利要求7所述的医疗装置,其中,所述至少一个温度传感部件包括第一温度传感部件和与所述第一温度传感部件的近端间隔开的第二温度传感部件;其中,
所述第一温度传感部件设置在所述可延伸部件的末端处;或
所述第二温度传感部件设置在所述轴处。
9.根据权利要求7所述的医疗装置,其中,所述至少一个温度传感部件包括第一温度传感部件和与所述第一温度传感部件的近端间隔开的第二温度传感部件;其中,在应用由所述电源提供的能量的过程中,所述第一和第二温度传感部件提供反馈来指示被切除的组织的区域。
10.一种用于治疗椎体的医疗骨凿装置,该装置包括:
手柄,其具有用于将所述骨凿装置电连接到电源的连接器;
轴,其具有从所述手柄延伸至工作端的轴线,其中,所述轴的第一导电部可电连接到所述电源的第一极;
致动机构可操作地连接至所述手柄,所述致动机构被配置为使所述工作端变形为并保持在铰接配置,其中所述工作端被配置为在施加驱动力时保持在铰接配置使得工作端的铰接配置创建空腔;以及多个可延伸部件,其可从所述轴延伸;
其中,所述可延伸部件可连接到所述电源的第二极,使得当接通时,电流在所述可延伸部件和所述轴之间流动;以及
其中,所述可延伸部件相对于所述轴的轴线径向不对称。
11.根据权利要求10所述的医疗装置,其中,所述可延伸部件从所述铰接形状的外部半径延伸。
12.根据权利要求10-11中任一项所述的医疗装置,其中,所述可延伸部件的数量在从2至10的范围内。
13.根据权利要求10-11中任一项所述的医疗装置,其中,所述可延伸部件从所述轴延伸少于10mm。
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BR112012027708B1 (pt) 2021-03-09
US20150335336A1 (en) 2015-11-26
US20110295262A1 (en) 2011-12-01
US10624652B2 (en) 2020-04-21
EP2563233B1 (en) 2020-04-01
CN106618669A (zh) 2017-05-10
US9125671B2 (en) 2015-09-08
BR112012027708A8 (pt) 2019-12-10
CN102958456A (zh) 2013-03-06
US20180028199A1 (en) 2018-02-01
EP2563233A1 (en) 2013-03-06
WO2011137377A1 (en) 2011-11-03
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BR112012027708A2 (pt) 2019-09-10
EP2563233A4 (en) 2014-11-19

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