CN101325919A - 电阻加热装置和用于鼻甲骨消融的方法 - Google Patents
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Abstract
本发明涉及一种电阻加热装置和用于鼻甲骨消融的方法,尤其涉及一种用于肥大组织(比如鼻甲骨)热消融的装置和方法,其具有适合于***组织的电阻加热元件。该装置使用DC电流来加热电阻加热元件,并且以相对低的电压水平和低的电流水平操作。该装置易于操作,并且可利用定时电路或计算机化控制***在没有反馈控制之下施加预定的时间。电阻加热元件由导热的非粘性薄覆层覆盖,比如Xylan、Teflon或其它含氟聚合物或适合材料。
Description
技术领域
下述发明涉及组织消融以及鼻甲骨缩减领域。
背景技术
慢性鼻阻塞通常是鼻甲骨增大的结果,鼻甲骨是覆盖有粘膜的鼻腔的卷状骨质突起。这些粘膜正好位于鼻子内侧,并且它们承受导致慢性充血、窦感染、睡眠障碍和其它慢性状况的慢性膨胀和肥大。最近,鼻甲骨的射频消融,称为射频消融(somnplasty),已经采用为用于鼻甲骨增大的治疗。在这个技术中,细长的射频探针***鼻甲骨的粘膜下层组织,并且射频能量穿过粘膜下层组织以加热和破坏(消融)这个组织的一小部分。在损坏的组织愈合并且由身体再吸收时,粘膜下层组织收缩并且减轻阻塞。愈合过程需用几个星期。
类似的射频消融过程还能用来收缩上颚中的肥大组织(以治疗打鼾和睡眠呼吸暂停)、脊椎盘中的肥大组织(以治疗椎间盘突出)、或者用于在大脑、肝脏、衰竭等中的各种肿瘤消融以及各种美容外科手术(眼皮下垂)。
由于射频装置使电流穿过身体,必须要警惕以避免过度的电流流动以及有害的电流流动至远离装置的区域。射频消融装置依靠于热反馈或阻抗监视以控制所施加的射频能量以获得实现消融所需要的温度(60-100℃)。这种反馈***是要确保装置不会将过度的能量传送入身体并损坏附近身体。射频消融装置还会引起不必要的神经刺激,并且必须小心使用以避免与心脏交互作用。射频消融装置会在附近组织结构中和远离施加点的区域中引起意外的组织损坏。
发明内容
附图说明
图1示出了将由热消融装置完成的典型鼻甲骨消融过程。
图2示出了适合于图1所示过程的热消融装置。
图3是图2所示热消融装置的远端的细节图。
具体实施方式
图1示出了具有增大鼻甲骨2的患者1的典型鼻甲骨消融过程。为了完成鼻甲骨热消融,医生将消融探针3的远端***穿过鼻孔4并且进入窦腔以到达鼻甲骨。医生将安装在远端6上的加热段5推入鼻甲骨,并且使远端前进进入粘膜下层组织,之后沿着鼻甲骨前进并且位于期望远的粘膜组织内。在对探针尖端的位置满意时,医生将开始探针远端处的加热段的加热,按照需要反复进行以使鼻甲骨消融至由医生所观察的状况所指示的程度。装置被设计来提供预定时间段的加热,通过比如定时电路、计算机控制***或植入微处理器之类的装置,其中时间段由定时电路的参数或控制***/微处理器的编程来预先确定,通过电路和/或控制***允许医生在任何时间关闭装置。
图2示出了适合于图1所示过程的热消融***。该***包括探针3,其包括把手部分11和***部分12以及DC电源13(电池或由家用电流供给的DC电源)。手柄部分包括操作按钮14和指示灯15、电源线16以及定时装置,无论其是简单的定时电路或板上计算机化控制***或微处理器。***部分包括细长海波管(slender hypotube)17,其在靠近加热段5大约2至3英寸(50-80mm)处弯曲大约15°度至20°的轻微角度。***部分标记有标识18,其指示探针远端至每个标记的长度,以使得医生能易于确定加热段的深度。操作按钮可包括任何适当的开关,并且可操作为拨动开关或双位置开关。指示灯可连接至电源、开关和定时装置以使得其在电流施加至加热段时发光。
图3是图2所示热消融装置的远端6的细节图。远端包括加热段5,其包括与电阻丝形式的第二电阻元件22串联的管状电阻加热元件21,它们同轴地布置在管式电阻器内。加热段沿着***部分的远端纵向地延伸,产生适合于针刺进入柔软身体组织的细长加热段。两个电阻加热元件沿着长度与绝缘材料23电绝缘。绝缘材料可包括陶瓷,比如氧化镁、氧化铝或其它具有适合热传导性的陶瓷。两个电阻器21和22在各自的远端电连接,最便利地通过金属尖端24,其是尖锐的以便于在探针尖端冷却时加热元件穿透入身体组织。电能通过导体25和26供应至加热元件,导体25和26连接至管状电阻加热元件和第二电阻元件的近端。加热元件覆盖有热传导覆盖物或涂层27,其还可是非粘性、低摩擦、电绝缘的材料,比如ePTFE或加热元件被安装在具有较短长度的热和电绝缘管路28的***部分的海波管17上,管路28在其内腔内接收加热元件的近端,并且其近端又由海波管接收。陶瓷比如锆硬化矾土(ZTA)、聚合物比如PEEK(聚醚醚酮)或其它适合的高温塑料或聚酰氨酰亚胺树脂是用于安装管的适合材料,不过也可使用任何适合的材料。
在适合于鼻甲骨消融的实施例中,选择装置部件来提供期望的加热特征以及提供便于安全***的机械性质。管状电阻加热元件(由标号21表示)的外部直径是0.029英寸(0.74mm),并且电阻加热元件包括inconel 625合金(一种不锈钢)。加热段包覆或覆有非粘性电绝缘材料(ePTFE、等)的薄层(0.001``(0.025mm)),该薄层具有足够的导热性以允许通过包覆层加热。延伸到安装管之外的电阻加热元件大约是0.345``(9mm)长(管式电阻器的总长度大约为0.46``(12mm))。加热元件的总电阻是0.1至0.25欧姆,优选地大约0.15欧姆。当以大约3至3.5安培,优选地大约3.2安培的恒定电流施加DC电流时,加热段将沿着加热段延伸到海波管和安装管之外的全部长度在大约60秒的时间内逐渐地加热鼻甲骨组织至80至100℃。加热以相对慢的速度发生,起始以每五秒间隔大约20至25℃的速度,并且在施加电流一分钟的过程中减速至每五秒间隔1至5℃的速度。控制装置操作来给加热段施加预定时间的电流。预定时间为至少大约30秒(优选为大约60秒)适合于鼻甲骨消融。预定时间可在制造中设置,或者可由医生在使用该装置之前改变。电阻加热元件的构造也可改变以提供更慢或更快的加热特征,以使装置适合各种治疗。施加至加热元件的电流和/或电压可改变以获得更慢或更快的加热特征,如由要执行的具体消融治疗所指示的。直流电优选地用于这种应用中,部分地由于其不会与附近的神经交互作用,并且非常少(如果有的话)的电流泄漏入身体(身体比电源线和电阻加热元件的铬镍铁合金的阻抗更大)。尽管直流电是优选的,不过电阻加热也可通过将射频电流或交流电供应至加热段来提供,因为电绝缘材料的覆层将阻止泄漏。
这个实施例中的海波管具有0.065英寸(1.7mm)的外部直径和0.057英寸(1.4mm)的内部直径(0.008``或0.2mm的壁厚),并且大约4英寸(100mm)长,并且具有距离装置远端大约2.25英寸(大约60mm)的18°弯曲。海波管的耐压强度(在其弯扣处的负载)在弯曲点处低于加热段的耐压强度。这个实施例中的海波管将在大约0.7至0.9磅,优选地大约0.75磅的压力负载下扭折或塌陷。这个特点确保了,如果医生将加热元件***鼻甲骨中并且遇到过度的阻力并且试图用可能损坏加热元件的压力***加热段时,替代地海波管将皱折。在海波管皱折时,医生能撤回探针并用新的探针重新开始这个过程。
虽然在鼻甲骨消融的环境中进行了描述,但是上述装置和方法可用于柔软上颚消融和通常在脊椎盘减少、肿瘤消融(尤其在大脑中)以及其它目前用射频消融来完成的外科手术的射频消融。因此,虽然装置和方法的优选实施例已经参照其开发环境进行了描述,但是它们仅仅是本发明原理的说明。其它实施例和构造可在不脱离本发明精神和所附权利要求范围之下设计。
Claims (10)
1.一种用于执行身体组织热消融的装置,所述装置包括:
适合于***身体的细长***部分,所述***部分具有适合于冷穿透身体组织的远端;
布置在***部分的远端上、沿着***部分的远端纵向地延伸的细长电阻加热段,所述电阻加热元件具有电绝缘覆层;
可操作地连接至电阻加热段的电源,所述电源可操作来将电能供应至电阻加热段以引起电阻加热段加热至组织消融的温度。
2.根据权利要求1的装置,其中电阻加热段包括管状电阻加热元件。
3.根据权利要求1的装置,其中加热段包括:
管状电阻加热元件;以及
布置在管状电阻加热元件内的电阻丝。
4.根据权利要求3的装置,其中加热段还包括尖锐远端,所述尖锐远端布置在管状加热元件的远端和电阻丝的远端上并且用来电连接所述管状电阻加热元件和电阻丝。
5.根据权利要求1的装置,其中加热段具有小于大约0.25欧姆的电阻并且电源可操作来提供小于大约3.5安培的恒定电流。
6.根据权利要求1的装置,还包括适合于对加热段施加预定时间的恒定电流的控制装置。
7.根据权利要求5的装置,还包括适合于对加热段施加大约60秒的预定时间的恒定电流的控制装置。
8.一种对患者执行鼻甲骨消融的方法,所述方法包括:
提供适合于穿入鼻甲骨的粘膜下层组织的细长电阻加热段;
将细长电阻加热段***鼻甲骨的粘膜下层组织;
将直流电施加至电阻加热段以给加热元件加热,从而加热鼻甲骨的粘膜下层组织以在没有电流穿过粘膜下层组织的情况下引起热消融。
9.根据权利要求7的方法,还包括:
给电阻加热元件施加预定时间的直流电。
10.根据权利要求7的方法还包括:
提供细长电阻加热元件,其呈管状电阻加热元件的形式,并且电阻丝布置在电阻加热元件内并且与之串联,所述电阻加热段具有0.1至0.25欧姆的电阻,
将3.0至3.5安培的直流电施加至电阻加热元件至少30秒的预定时间。
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Also Published As
Publication number | Publication date |
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CA2623447A1 (en) | 2007-04-05 |
EP1933745A2 (en) | 2008-06-25 |
JP2009511097A (ja) | 2009-03-19 |
WO2007038415A3 (en) | 2007-06-14 |
AU2006294893A1 (en) | 2007-04-05 |
WO2007038415A2 (en) | 2007-04-05 |
US20070073282A1 (en) | 2007-03-29 |
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