CN1272776A - 使用电磁能的细胞坏死仪 - Google Patents
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Abstract
一种缩小舌内选定部位体积的仪器,包括一个手柄和至少部分在手柄内的电极。电极包括电磁能传送表面和可从手柄内伸进至舌内的机构。有一电极伸进元件与电极相连,并构造成可将电极伸进至舌内一定距离。该伸进距离足以使得电极将电磁能传送给选定的组织部位,缩小选定组织部位的体积,但不伤及舌下神经。电极连有电线。
Description
发明背景相关申请
本申请是1996年5月3日的美国专利申请08/642,327“治疗气路阻塞的方法”的部分继续申请,08/642,327则是1996年2月23日的美国专利申请08/606,195“治疗气路阻塞的方法”的部分继续申请,08/606,195交叉参考了1995年8月18日的美国专利申请08/516,781“去除软腭组织的切除仪器和系统”,发明人为Stuart D.Edwards,Edward J.Gough和David L.Douglass,此申请是1994年5月9日的美国专利申请08/239,658“通过RF切除悬雍垂来缓解打鼾的方法”的部分继续申请。本申请还涉及1996年5月3日的申请08/642,053“治疗气路阻塞的方法和仪器”,以上各项申请均纳入本发明作为参考。
发明领域
本发明涉及用于治疗气路阻塞的仪器,更具体地说,是在选定的头颈部结构内部截面处产生选择性细胞坏死但不伤及重要结构的一种仪器。
相关技术
睡眠-窒息综合征这一医学状况的特征是白天嗜睡,早晨手臂疼痛,智力衰退,心律不齐,睡眠中反复打鼾。这是由患者睡眠过程中窒息频繁发作引起的。这种综合征可分为两类。一类称为“中枢性睡眠窒息综合征”,特征是反复的呼吸丧失。第二类称阻塞性睡眠窒息综合征,特征是睡眠过程中因患者上呼吸道气路阻塞或患者呼吸道朝向喉头但不包括喉头的那部分阻塞所致的反复窒息发作。
目前的治疗包括多种药物、手术和理疗手段。药物治疗包括使用诸如普罗替林,甲羟孕酮,乙酰唑胺,茶碱,尼古丁等药物,但避免使用诸如镇静剂或酒精等中枢神经系统抑制剂。上述药物疗法有时有所帮助,但不完全有效。而且,频繁用药具有副作用。
手术治疗包括悬雍垂切除术,扁桃体切除术,矫正严重缩颌的手术和气管造口术。在一种手术治疗中,标准LeFort I骨切开术与矢状分裂支骨切开术结合,将上颌骨、上颚和下颚(chin)推前。这样的手术可能有效,但对此类患者可能因手术的危险性而无法接受此类手术,而且,患者常不接受此类手术。
理疗方法包括减肥、夜间采用鼻咽气道、鼻CPAP和各种舌夹持装置。这些治疗方法也有一定的疗效,但麻烦、不舒服,并且患者经常不愿意长时间使用。减肥可能有效,但患者很难做到。
在患有中枢性睡眠窒息综合征的患者中,有采用膈神经或膈肌起搏的。膈神经或膈肌起搏包括采用电刺激来调节和控制患者两边受膈神经支配的膈肌,以帮助或支持换气。这种起搏方式见J.Mugica等人的论文“直接膈肌刺激(DirectDiaphragm Stimulation)”(PACE卷10,1987年1月至2月)、J.Mugica等人的“用于人患者的膈肌起搏系统的初步试验(Preliminary Test of a Muscular DiaphragmPacing System on Human Patients)”(见“神经刺激(Neurostimulation)”:综述,1985,第263-279页)以及Nochomovitez等人的“呼吸的电激活(Electrical Activation ofRespiration)”(见IEEE工程,医学和生物卷,1993年6月)。
然而,人们发现,这类患者中许多还患有一定程度的阻塞性睡眠窒息,在起搏器增强吸气力量时,情况更严重。激活膈肌诱导换气还会在吸气时造成上气路萎陷,将患者的舌下拉到咽喉下方,造成患者窒息。于是,这类患者将需要施行气管切开来进行完全治疗。
F.Kaneko等人在“生理性喉起搏器”中描述的生理性喉起搏器(见Trans AmSoc Artif实习医师组织1985)测量肺的换气量,并刺激相应神经打开患者的声门,以此治疗呼吸困难。该装置不能治疗睡眠窒息。该装置产生一个与肺换气量成正比的信号,所以,产生的该信号太迟而不能用作治疗睡眠窒息的指示。由于阻塞,睡眠窒息中经常没有换气量。
能够有效治疗阻塞性睡眠窒息的一种方法是气管切开术。但是,这种手术并发症发病率较高,并且因为影响外观而不为许多患者所接受。其他的手术方法包括采用标准Le Forte I切骨术与矢状分裂支骨切开术结合。这是一种大手术,要求将上颌骨、上颚和下颚前移。
打鼾通常有两种类型。区别在于其病灶的位置。第一种是腭帆性打鼾,是由于包括腭帆,扁桃体内弓和后弓以及悬雍垂在内的全部软腭结构振动引起的。腭帆性打鼾是因经鼻和口吸入的气流造成软腭象旗帜那样扇动而引起的。张开的口腔象音箱一样增强了这种振动的声强。
第二种类型是咽打鼾,这种打鼾是一种罗音,甚至具有哨鸣音。它是由于舌根一再局部堵塞口咽峡(oropharyngeal isthmus),而舌根以外的部分则被挤靠在咽后壁上而造成的。这造成了呼吸困难的感觉,构成了睡眠窒息综合征。这两种类型的打鼾很容易联合出现在同一个患者身上。
采用外科手术来矫治窒息已有好多年。然而,治疗咽打鼾的上颌手术是一项大手术,需持续数小时,而矫治腭帆性打鼾的悬雍垂-颚咽成形术也不是没有缺点的。这就是为什么修复术和其他防治装置那么普及的原因。
最近,人们采用激光切除部分软腭。如果切除的组织太多,会造成严重后果。激光切除的程度很难控制,并且常需要进行多次治疗。另外,患者的喉咙在几周内疼痛剧烈。
美国专利4,423,812公开了一种环形电极设计,它的特征是,在电极轴上的导线支承结构之间悬吊着一段裸露的工作导线部分。用裸露导线来刮剥组织,而导线的相邻部分支承着一个电极轴,它是绝缘的,用以预防意外灼伤患者,从而使得医生能够在手术过程中用绝缘部分定位和引导工作导线部分。然而,这要求医生在多次触及中刮去阻塞组织连续的薄表层,以避免大量切除及其副作用。
美国专利5,046,512也公开了一种治疗打鼾和窒息的方法。这种方法将通向使用者的气流调节到与流经使用者鼻腔的气流量相当。一相连的装置提供了一个具有一个主体部分的装置,该主体部分足够宽以将受试者的牙齿分开。它包括一个在面积上与使用者鼻腔面积相当的气体通道。
常有人建议采用口腔矫正器来治疗睡眠疾病。已知,相对上颌前移下颚能保持咽部气道敞开从而根治或缓解窒息和打鼾。人们已经研制了几种口腔齿科矫正器,由使用者夜间佩戴,将下颚固定在一个向前突出的位置上。这样的齿科矫正器主要由丙烯酸或弹性聚合物锥形块(elestomeric bit block)构成,与定制的固定在使用者上下牙齿之间的牙齿矫正器或运动口腔防护器相似。这种装置是可以调节的,用以改变向前突出的程度。
美国专利4,901,737公开了一种口腔矫正器,采用这种装置,使上颚处于一个下方、开放和向前突出的位置,而不是通常的颌闭合位置上,由此减轻打鼾。一旦口腔医生或内科医生对特定患者确定了有效缓解打鼾的位置,就取一个上牙床模型和一个下牙床模型,制成一个矫正器的模板。这种装置包括一对由牙科丙烯酸材料形成的V形间隔元件,伸入上、下颌牙床之间形成一个整体口腔构件。
尽管这种牙科矫正器被证明能够有效地保持下颚突出以改善气道的开放性,但它们常会产生不良的副作用。其中最常见的一种是颞下颚关节与相关颌肌和韧带病变加重,特别多见于在睡眠时会磨牙的患者。颞下颚关节病变与包括偏头痛在内的多种生理失调有关。因此,许多睡眠窒息和打鼾患者无法忍受长期使用目前的抗打鼾牙科矫正器。
已有人用手术或药物通过缩小鼻甲来打开被堵塞的鼻腔气路。手术的例子包括鼻前后筛窦切除术,见D.Rice和S.Schaefer的论文“内窥镜副鼻窦外科手术”(Raven出版社,1988);M.E.Wigand、Messerklinger和Stamberger的论文;以及美国专利5,094,233。例如,正象美国专利5,094,233中所描述的那样,Wigand手术包含:从后面开始横切中鼻甲、显露蝶窦口以及打开后筛室以便进行后续手术。在蝶窦切除步骤中,识别蝶窦口,并切除鼻窦的前壁。接着,可以从与蝶骨的连接处进入后筛室,并识别凹筛骨,作为进一步切开的解剖学标记。在鼻前筛房切除术中,向前切除筛骨直至前隐窝。有报道称,诸如凹筛骨或筛骨板的出血、感染、穿孔,以及中鼻甲瘢痕或粘连等并发症与这种手术相关。
手术造成的问题之一是鼻甲与相邻鼻区域之间发生术后粘连,例如在中部与中隔膜粘连,在后部与筛骨窦区域的鼻后壁粘连。这些情况下,即使成功的手术也可能结果不好。有些外科医生提出在手术最后切除部分鼻甲以避免这些并发症,但是造成了持久的后遗症(形成痂壳和鼻腔清洁问题)。鼻甲粘连影响了内窥镜手术的声誉。人们已作出努力以减少与手术治疗鼻甲组织相关的并发症,例如使用鼻甲套,美国专利5,094,233。
美国专利3,901,241说明了一种冷冻手术治疗,据说有助于收缩鼻甲。
也已开发出了缩小鼻甲的药物。然而,药物经常不是完全有效,而且通常不能永久性缩小鼻甲。此外,药物可能有副作用。
需要有一种方法和装置来清洁堵塞的鼻通道。较好的是,这种方法和装置的使用只需要最小的手术,或者只有最轻的术后并发症。还希望,这种方法和装置不通过手术切除或物理去除组织来缩小鼻甲结构。还希望,这种方法和装置能够缩小鼻甲,增加鼻通道内的气流量,但不至于因此减少流向视神经和/或视网膜的血液而造成永久性的视力损伤。
人们希望有一种不需要使用牙科矫正器治疗打鼾和睡眠窒息的切除仪器。人们还需要一种非口腔牙科矫正器的治疗装置,它能够有效而安全地去除软腭的选定部位,对患者没有副作用。而且,还需要有一种组织削除装置能够在削除过程中保留目标削除组织。
需要有一种治疗打鼾的仪器,它通过最少量的切除而缩小软腭和/或悬雍垂。还需要一种治疗打鼾的仪器,其结构适合将能量传输装置的至少一部分定位在软腭和/或悬雍垂内部,将削除的能量传输到该部位以缩小软腭和/或悬雍垂的体积。
发明概述
所以,本发明目的之一是提供一种在不同的头颈部结构的选定部位造成选择性细胞坏死的仪器。
本发明另一目的是提供治疗气路阻塞的仪器。
本发明另一目的是提供造成受控舌细胞坏死的仪器。
本发明另一目的是提供造成悬雍垂或其它软腭结构受控细胞坏死的仪器。
本发明另一目的是提供造成鼻甲结构受控细胞坏死的仪器。
通过一台在口腔内减小舌内选定部位体积的细胞坏死仪实现了上述及其他目的。该仪器包括一个手柄。电极连接于手柄的末端,电极具有一个用于刺穿组织的末端。电极的构造适合在口腔内灵活操纵,以刺入舌表面,进入舌内足够的深度以到达某组织部位,向该组织部位传送电磁能引起细胞坏死,但不伤及舌下神经的主干。电极连有电线。
在本发明另一实施例中,细胞坏死仪减小悬雍垂内选定部位的体积。该仪器有一个手柄。有一个电极连接于手柄的末端,电极具有一个用于刺穿组织的末端。电极的构造适合在口腔内灵活操纵,以刺入悬雍垂表面,进入悬雍垂内足够的深度以到达某组织部位,向该组织部位传送电磁能引起受控的细胞坏死,并矫正悬雍垂在口腔内的位置,并减少悬雍垂外黏膜表面的细胞坏死。电极连有电线。
在本发明另一实施例中,细胞坏死仪减小鼻甲结构内选定部位的体积。该仪器有一个手柄。有一个电极连接于手柄的末端,电极具有一个用于刺穿组织的末端。电极的构造适合在口腔内灵活操纵,以刺入鼻甲结构表面,进入鼻甲结构内足够的深度以到达某组织部位,向该组织部位传送电磁能引起受控的细胞坏死,加宽鼻通道。细胞坏死仪输送的电磁能不足以减少流向视神经和/或视网膜的血液而造成永久性视力损伤。电极连有电线。
在本发明另一实施例中,细胞坏死仪减小软腭结构内选定部位的体积。该仪器有一个手柄。有一个电极连接于手柄的末端,电极具有一个用于刺穿组织的末端。电极被的改造适合在口腔内灵活操纵,以刺入软腭结构表面,进入软腭结构足够的深度以到达某组织部位,向该组织部位传送电磁能引起受控的细胞坏死,并矫正软腭结构在口腔内的位置,并减少软腭结构外黏膜表面的细胞坏死。电极连有电线。
附图简述
图1A-B显示口腔和本发明细胞坏死仪位于口腔内的侧视图。
图1C是一口腔侧视图,显示治疗后舌位的矫正。
图2-4显示各种细胞坏死区的形成。
图5显示向组织引入药团溶液。
图6A是本发明细胞坏死仪与供能源连接的透视图。
图6B是用于在组织表面以下形成细胞坏死区的本发明中空电极的局部放大剖面图。
图7是图6B中电极末端的剖面图。
图8是具有一个用于调节液体流量的密封塞的中空电极的剖视图。
图9显示在悬雍垂内形成细胞坏死区和在口腔内悬雍垂的位置。
图10显示在鼻甲内形成细胞坏死区和在口前内鼻甲的位置。
图11是鼻腔动脉的剖面图。
图12是头部剖面图,显示鼻腔动脉。
图13是从侧面通过鼻腔的头部剖视图,显示用本发明细胞坏死仪治疗后鼻甲缩小。
图14是图13的局部放大剖视图。
图15是头部剖视图,显示在软腭结构内形成细胞坏死区。
图16是图15软腭结构的剖视图,显示形成细胞坏死区后软腭结构的复位。
图17是可用于图1A-C细胞坏死仪中的反馈控制系统的流程图。
图18是图17反馈控制系统所用模拟放大器,模拟多路转换器和微处理器的流程图。
图19是与图18模拟放大器连接的电流计和电压计的流程图。
详细说明
参见图1A-C,细胞坏死仪10被用来缩小头颈部结构内选定部位的体积,更具体地说是与气路通道相关的结构。合适的解剖结构包括但不限于舌、悬雍垂、软腭组织、扁桃体、腺样结构和鼻甲结构等。图1A-C中所显示的细胞坏死仪10具有与电极14相连的手柄12。手柄12可以是电极14的基部,其构造能够将细胞坏死仪放入选定的解剖结构和从中取出,如实施例之一中那样,电极12的基部是绝缘的。手柄12和电极14的大小和形状适合在口腔16内灵活操纵,刺入舌表面18,进入舌22的内部20,进入足够深度24,到达组织部位26。向组织部位26传送电磁能,形成细胞坏死区28,但不伤及舌下神经的主干。电线30与电极14连接。就在此揭示的目的而言,舌下神经的主干是那些一旦受伤将造成语言或吞咽能力部分或完全丧失的分支。如图1C所示,舌22中接受治疗的结构在口腔16内的位置得到了矫正。用本发明细胞坏死仪,舌22的后部(如箭头所示)前移离开空气通道。结果是加大了气路剖面的直径。
手柄12宜用绝缘绝热材料制造。电极14可用例如不锈钢等导体材料制造。此外,电极14可用成形记忆金属(memory metal)制成,例如购自RaychemCorporation,Menlo Park,California的镍钛。在实施例之一中,为了获得所需的挠度,只有电极14的末端是用成形记忆金属制成的。
细胞坏死仪10可具有观测能力,包括但不限于观测器,放大目镜,光纤,摄像等。
电极14可具有绝缘体32,其长度可根据电极14外表面的环境进行调节。绝缘体32起着热或RF能流屏障的作用。绝缘体32可以是套管形的,其位置可在电极14的外部调整。实施例之一中,绝缘体是聚酰胺材料制成的,是0.002英寸的收缩覆盖层。聚酰胺绝缘层是半刚性的。
手柄12末端34的直径可较小,以便放置,灵活操纵,易于进入较小的开口,和提高电极14穿透区域的可见度。
为了在口腔16中使用细胞坏死仪10,先对舌22进行表面麻醉,然后进行局部麻醉。在麻醉起效后,医生在舌尖附近抓住舌体22,用网垫可夹得更牢。然后,向前拉出舌22,使得舌体和舌根更靠前,以便触及。握住手柄12,将电极14的末端放至舌表面18。图1A-C中电极14的位置显示细胞坏死区28位于黏膜表面36之下,形成保护区38。电极14的绝缘部分40避免能量传到舌下神经主干和/或黏膜表面36。
电极14可具有位于弯曲区44的转角42,与手柄12的侧向纵轴平行。电极14可根据解剖结构和插入解剖结构内的位置形成不同的弯曲区。使用弯曲夹具(未显示),医生可在治疗时根据需要调节转角42的弧度。
较好的是,本说明书中的“电极”一般指能量传送装置,包括但不限于阻抗加热,RF,微波,超声波和液相热喷射。较好的能源是RF源,电极14则是RF电极,以双极或带接地垫式电极的单极模式工作。在传送RF能的单极模式中,单个电极14与一惰性电极片合用,该电极片加在机体上形成另一接触,形成回路。当使用2个以上电极14时则可能进行双极工作。可使用多个电极14。
当能源是RF时,RF能源可具有多个通道,分别向各电极14传递调制能量。这降低了较多能量传递到高电导区时的偏多加热和低电导组织内的电极14周围的偏少加热。如果进入组织内的水分和血液均匀,则可使用单通道RF能源提供治疗用的能量,形成的细胞坏死区大小也较一致。
可在电极14的末端,绝缘体32的末端,以及细胞坏死仪10的其他位置安装一个或多个传感器46。传感器46为常规设计,包括但不限于热敏阻抗,热电偶,阻抗线等。适宜的传感器46带有铜(copper constantene)T形,J形,E形,K形热电偶,光纤,阻抗线,热电偶IR检测器等。
当电流流出电极14时,电极14可能经历一个很陡的温度梯度。这会造成紧靠电极14的组织达到100℃或以上,而5-10mm开外的组织却是或接近体温。因为存在这一温度梯度,所以常需要多次放置电极14或使用多个电极14形成所需大小的细胞坏死区28。紧靠电极14强烈加热可能造成电极14邻近组织脱水。如果组织内水分被灼干,就不再有电流流经组织,加热随之终止。该问题可通过低速加热来解决,但需要较长的治疗时间。
参见图2至4,所公开的本发明实施例之一中,电极14具有中空腔48和多个孔隙,液体介质可经孔隙流过。适宜的液体介质包括但不限于冷却液和加热液,电解质溶液,化学削蚀液,消毒液等。
适宜的电解质溶液是钠盐溶液,钙盐溶液,钾盐溶液等。电解质溶液加强组织的导电性。当高电导溶液注入组织时,被灌注组织的阻抗下降而电导升高。此时,电极14周围的组织不易脱水,使得组织携带RF能的能力大大提高。被浓缩电解质溶液高度灌注的组织区域其电导高至足以作为电极起作用。较大的(液体)电极的效果是可传导更大的电流量,因而能够在给定时间内加热更大体积的组织。
电解质溶液灌注除了形成较大的电极面积之外,还由此可能如图5所示注射出一个或多个电解质溶液药团50。这样,RF流52能够流经电极14周围的浸润组织,并随阻抗最小的路径进入相邻药团所浸润的组织。
按照热组织损伤的需要注入电解质溶液,单个电极14可加热较大体积的组织,所形成的细胞坏死区28的形状可能正符合所需的细胞坏死面积。这简化了对形成细胞坏死区28的控制,使得医生能够在短时间内造成较大的损伤。
此外,可以降低注入电解质溶液的电导。在保持避免灼干电极14邻近组织这一优点的同时,灌注组织内的阻抗升高了。这加强了对电极14邻近组织的加热。可通过调节灌注组织的电导来调节细胞坏死区28的面积和控制热损伤程度。
还可以通过电极14引入消毒液。适宜的消毒液包括但不限于Peridex,这是一种嗽口液,含溶于含水基质中的0.12%chlorhexidine glucinate(1,1-己亚乙基二[5-(对氯苯基)双胍]二-D-葡糖酸酯,11.6%乙醇,甘油,PEG40脱水山梨醇arisoterate,赋味剂,糖精钠和FD&C1号蓝。消毒液可在细胞坏死之前,期间和之后引入。
参见图6至8,电极14可具有与控制单元54连通的中空腔48,控制单元54控制流体通过导管56的传递,导管56接受冷却液或加热液。只有电极14末端的14’部分被冷却或加热。
引入冷却液不用绝缘体32就能够减少表层的细胞坏死。这保留了表面黏膜和/或上皮层,而且保护了附近或细胞坏死区28内部某组织部位不致接受到足以造成细胞坏死的能量。例如,可能需要将电极14插入某器官,其所在位置靠近或者就在必须加以保护的地方,这包括但不限于血管,神经节,腺体等。冷却使得热能能够以预定的方式传递,避免了对重要结构的加热。
中空电极14中可具有密封塞58,它用来确定电极14接受冷却液的长度。密封塞58在其外径上可具有多个密封滑动片60。液管62与密封塞58的底部相连并靠近密封塞58底面。液管62上有多个分液口64。冷却液,可以是盐水或其他生理相容性液体,从控制器54经过管道56内的一小径双中空管流入。冷却液经液管62流到最末端,在此通过分布在液管62外径的分液口64传送。然后,冷却液从中空腔48内流过,与电极14的壁结构直接接触,壁结构通常是金属的,换热率高。冷却液流向被保护的电极14的底端,并通过液管62的第二空腔流向控制单元54,控制单元54具有一个供液容器和一个用于接受和保留用过冷却液的回收容器。
电极14可具有一个或多个测定组织温度的传感器46。数据被反馈给控制单元54,经过计算后保存在控制单元54的微处理器存储器内。向电控微量泵(未显示)发出指令,以适宜的流速在适宜的时间内通过液体管路输送液体,达到对组织温度的控制。
控制单元54的容器能通过冷却或加热液体来控制冷却液温度。或者,可使用足够大的容器,在其中引入处于或接近正常体温的冷却液。用绝热容器,无需制冷或加热冷却液就可以完全控制组织的温度。
用管心针68移动密封塞58可以调节冷却区66的大小和位置,管心针由手柄12上的滑块70控制。以这种方式,可沿电极14长度方向移动冷却区66的位置,所以冷却区域是密封塞58的底部。此时,需要使得冷却区66的长度小于电极14,因此可距离第一或末端密封塞58的底部远处安装第二个密封塞58,于是,冷却液在密封塞58的底部进入液管62的第二空腔。两密封塞58之间的距离决定了冷却区66的长度。在该实施例中,末端和基部密封塞58受管心针68驱动一起移动,调整冷却区66的位置。
另一实施例中,末端和基部密封塞58是分别调节的。这样能够同时改变冷却区66的位置和长度。
一般在使用中,冷却区66的位置使得在形成所需细胞坏死区28的同时,待治疗组织74表面上预定厚度的黏膜或上皮组织72被保护,如75处所示。
另一特征是能够告知医生电极14插入组织的长度和被保护区域的深度32。为此,细胞坏死仪10的一部分与黏膜或上皮表面72接触。这可以用接触套环76或形状贴和待治疗器官或解剖特征的较大表面来做到。套管78将使接触套环76与手柄保持一种维度关系,电极14、液管62和管心针68都从套管78内通过。保持着这种维度关系,就能够由手柄12上的标度指示表明电极14末端距接触套环76或细胞坏死仪10表面的距离。于是可确定冷却区66距离接触套环76或细胞坏死仪10表面的距离。因为冷却完全在电极14内,不冷却外部绝缘体32,所以,电极14容易穿透组织,没有绝缘体32存在时的抗力或阻力。
在另一实施例中,密封塞58和直接的冷却液流动被一滑移内冷却塞取代,滑移内冷却塞可用高换热率材料制成。适宜的冷却塞材料包括但不限于铜、铍铜、银和铝合金。冷却塞的大小与针14的内表面紧密配合。这能够将热量从电极14传给却密封塞。在该实施例中,冷却塞具有冷却液流经的内通道。这将热量从冷却塞吸出。
虽然这种实施方式的冷却效率不如冷却液与电极14的内表面直接接触,但冷却液与机体的分离更彻底。这减少了其他实施例中通过密封塞58滴漏的可能性。
冷却的另一实施例使用了换热管技术。一密封舱含有能够在不同温度迅速蒸发和冷凝的混合气体,促进了高效换热。该实施例中,手柄12内的一个冷却模块冷却换热管的底端,使热量从冷却区66传到该冷却模块。
细胞坏死仪10可用于在影响气路通道的其他结构内造成细胞坏死,这包括但不限于悬雍垂、鼻甲、软腭和扁桃体。
如图9和10所示,细胞坏死仪10被用于在悬雍垂80内造成一个或多个细胞坏死区28。电极12的构造可在口腔16内灵活操纵,刺入悬雍垂的外表面,进入悬雍垂内部足够深度到达某组织部位,向该组织部位传送电磁能,造成受控的细胞坏死。细胞坏死区28的形成调整了接受治疗的悬雍垂80在口腔16内的位置(如箭头所示),同时基本保留了悬雍垂80外部的黏膜层82。在悬雍垂80内形成细胞坏死区28的同时没有在悬雍垂80顶端86处形成溃疡线。受控的细胞坏死将悬雍垂收紧和矫形。
在治疗悬雍垂80时,电极12可具有多种几何形状,并可具有一个弧形末端。可一次或分多次堆叠出不同的细胞坏死区28。这使得医生能够控制被治疗的组织量,并在继续处理前评价每次治疗的结果。因为外黏膜组织不受处理,所以患者的痛楚和不适很少。
参见图10,细胞坏死仪10被用于在鼻甲结构88内形成细胞坏死区28,鼻甲结构包括内鼻甲,中鼻甲,上鼻甲和以上多处。电极14的构造能够在鼻孔内灵活操纵,刺入鼻甲结构表面90,进入鼻甲结构88内部足够深度到达某组织部位,向该组织部位传送电磁能,造成鼻甲结构88的受控细胞坏死,以扩大鼻通道90。
足够的电磁能传递到组织部位,造成鼻甲结构内的受控细胞坏死,但不至于限制流向视神经和/或视网膜的血液(图11)。如图12所示,阻碍流向视神经和/或视网膜的血液可能损伤视神经和/或视网膜,造成永久性视力损伤。
仍参见图10,电极14造成细胞坏死区28,并通过只去除部分鼻甲缩小了鼻甲结构88,去除量足以扩大鼻通道但不会造成永久性的:(i)嗅觉障碍;(ii)鼻干;(iii)萎缩性鼻炎;(iv)睫状功能丧失或(v)伤及鼻腔神经造成鼻结构或面部结构活动性的永久性丧失。在鼻甲结构88内形成切除区矫正了鼻甲结构88的位置。实施例之一中,被去除的下鼻甲黏膜层不超过33%。去除更多可能造成嗅觉障碍,永久性鼻干和/或睫状功能丧失。
如13和14所示,细胞坏死仪10可有调地部分切除鼻甲结构88,矫正鼻甲在鼻腔内的位置,“开阔”过敏患者等的鼻腔。
另一实施例(图15和16)中,细胞坏死仪10缩小软腭结构94内选定部位的体积。电极14的构造可在口腔16内灵活操纵,刺入软腭结构的表面96,进入足够深度到达组织部位,向该部位传送电磁能,造成受控的细胞坏死区28,矫正软腭结构94在口腔16内的位置,减少软腭结构94外黏膜表面98的坏死。如箭头所示,形成细胞坏死区28矫正了软腭结构94的位置,收紧了软腭结构的内部组织。
同样,本领域熟知的许多造影设备和方法可用来放置电极14的到位和/或确定细胞坏死量。
实施例之一中,细胞坏死仪10与一个开放或闭合环路反馈系统连接。参见图17,开放或闭合回路反馈系统将传感器46与能源92相连。该实施例中,电极14是一个或多个RF电极14。可以理解的是,也可以将其他能量传送装置14与该反馈系统联用。
监测组织或RF电极14的温度,并根据该数据调节能源92的输出功率。此外,还可以监测口腔内的消毒情况。在需要时,医生可以对该闭合或开放回路系统进行手控。闭合或开放回路系统中可包括一个微处理器,用于开关电源并调节功率。闭合回路系统使用微处理器94作为控制器,监测温度,调节RF功率,分析结果,反馈结果,然后调节功率。
使用了传感器46和反馈控制系统,可在选定时间内将RF电极14附近组织维持在所需的温度而不影响输出。每个RF电极14都与能源相连,各自产生彼此独立的输出值。该输出值在选定的时间内在RF电极14处保持选定水平的能量。
通过RF电极14传输的电流由电流计96测量。电压由电压计98测量。然后由功率和阻抗计算器100计算阻抗和功率。然后,在用户界面和显示器102上显示这些值。反映功率和阻抗值的信号由控制器104接收。
控制器104产生一个与实际测得值与要求值之间差异成正比的控制信号。功率回路106用该控制信号调节输出功率到合适的水平,以维持相应RF电极14传送所需的功率。
以类似方式,反馈回路根据传感器46测得的温度维持选定的功率。传感器46处的温度被作为安全措施在超过最大预设温度时阻断能量的传递。实际温度是温度测量装置102测得的温度,该温度由用户界面和显示器102显示。控制器104产生一个与实际测得值与要求值之间差异成正比的控制信号。功率回路106用该控制信号调节输出功率到合适的水平,维持传感器46处于所需的的温度。可包括一个多路转换器来测定电流、电压和传感器46处的温度,可以单极或双极模式向RF电极14传递能量。
控制器104可以是数字或模拟控制器,或带软件的计算机。当控制器104是一台计算机时,它可以包括一个与系统总线相连的CPU。该系统可包括一个键盘、磁盘驱动器或其他持久性存储系统、显示器和其他本领域熟知的配件。与总线相连的还有程序存储器和数据存储器。
用户界面和显示器102包括一个操作者控制器和显示器。控制器104可与造影系统相连,造影系统包括但不限于超声波、CT扫描仪、X光、MRI、乳房X线照相等。此外,还可以使用直接观察和触觉造影(tactile imaging)。
控制器104用电流计96和电压计98的输出值维持RF电极14在选定的功率水平。传递的RF能量控制着功率。可以在控制器104内画面显示输出功率,也可以画面显示传递量的现值。
控制器104的电路、软件和反馈形成了对过程的控制,并独立于电压或电流的变化维持选定的功率设定值,用于改变:(i)选定的功率设定值,(ii)工作周期(开-关时间),(iii)双极或单极能量传输和(iv)液体传输,包括流速或压力。这些过程变量受到控制并被改变,同时根据传感器46测得的温度维持着所需的功率传递,不受电压或电流变化的影响。
参见图18,电流计96和电压计98连接于模拟放大器110的输入端。模拟放大器110可以是与传感器46一起使用的常规微分放大器环路。模拟放大器110的输出端继而通过模拟多路转换器106连接到A/D转换器108的输入端。模拟放大器110的输出是电压,它代表了各自感觉到的温度。由A/D转换器108将数字化的放大器输出电压提供给微处理器94。微处理器94可以是摩托罗拉出品的68HCII型。然而,可理解的是,任何适合的微处理器或一般目的的数字和模拟计算机可用来计算阻抗和温度。
微处理器94接连收到并储存代表阻抗和温度的数字信号。微处理器94收到的每个数字值代表着不同的温度和阻抗。
计算出的功率和阻抗值显示在用户界面和显示器102上。或者,在显示功率和阻抗的数值之外,可由微处理器94将阻抗和功率计算值与功率和阻抗的限定值比较。当计算值超过预定的功率或阻抗值时,用户界面和显示器102上会给出警示,并减少、调节或中断RF能的传递。来自微处理器94的控制信号可改变能源92提供的功率水平。
图19是温度/阻抗反馈系统的流程图,该系统用于控制温度和通过输入装置14控制液体流速。能量由能源92传递给RF电极14,并传递给组织。监测器116根据传递给组织的能量确定组织阻抗并将测得阻抗与设定值比较。如果测得阻抗超过设定值,则向能源92发出截止信号,中断能量向电极14的继续传递。如果测得阻抗在可接受的极限度内,则持续地向组织供能。在能量施加过程中,传感器46测定组织和/或电极14的温度。比较器120接收代表测得温度的信号,并与代表所需温度的预设信号比较。如果组织温度过高,比较器120向流速调节器122发出信号表示需要更高的控温液体流速,或者,如果温度没有超过所需温度,则保持流速不变。
以上是对本发明优选实施方式的说明,是为了说明本发明。这并不是本发明形式的穷举或将本发明限定于以上具体形式。显然,许多修改对本领域技术人员来说是显而易见的。本发明的范围仅由以下权利要求及与之对等的表达方式来限定。
Claims (63)
1.一种用于在口腔内缩小舌内选定部位体积的细胞坏死仪,它包括:
手柄;
与手柄末端连接的电极,具有刺入组织的末端,电极的构形适于在口腔内灵活操纵,以刺入舌表面,进入舌内足够深度到达组织部位,向该组织部位传送电磁能,造成受控的细胞坏死,但不伤及舌下神经主干;和
与电极相连的电线。
2.根据权利要求1所述的仪器,其中的电极是RF电极。
3.根据权利要求2所述的仪器,它还包括与RF电极相连的RF能源。
4.根据权利要求1所述的仪器,它还包括与电极相连的冷却设备。
5.根据权利要求4所述的仪器,它还包括与冷却设备相连的流速控制装置,被构造成能够控制流经冷却设备的冷却液的流速。
6.根据权利要求1所述的仪器,它还包括至少部分包围在电极外的绝缘材料。
7.根据权利要求6所述的仪器,它还包括与电极相连的传感器。
8.根据权利要求1所述的仪器,它还包括位于电极末端的传感器。
9.根据权利要求1所述的仪器,它还包括与电极相连的反馈控制装置,传感器和RF能源。
10.根据权利要求1所述的仪器,它还包括与电极相连的灌注液来源。
11根据权利要求1所述的仪器,其中的电极有一端从手柄外延伸至舌内的伸进长度,该伸进长度足以使得能量传送表面定位于选定的部位并传送足够的能量造成细胞坏死而不伤及舌下神经主干。
12.一种用于缩小悬雍垂内选定部位体积的细胞坏死仪,它包括:
手柄;
与手柄末端连接的电极,具有刺入组织的末端,电极的构造适于在口腔内灵活操纵,以刺入悬雍垂表面,进入悬雍垂足够深度到达组织部位,向该组织部位传送电磁能,造成受控的细胞坏死并矫正悬雍垂在口腔内的位置,同时基本保留悬雍垂的悬雍垂外黏膜层;和
与电极相连的电线。
13.根据权利要求12所述的仪器,其中的电极构形适合造成受控的细胞坏死并矫正悬雍垂位置但不在悬雍垂尖形成溃疡线。
14.根据权利要求12所述的仪器,其中的电极构形适合造成受控的细胞坏死并收紧悬雍垂组织以矫正其位置。
15.根据权利要求12所述的仪器,其中的电极构形适合造成受控的细胞坏死并矫正悬雍垂组织的形状以矫正其位置。
16.根据权利要求12所述的仪器,其中的电极是RF电极。
17.根据权利要求13所述的仪器,它还包括与RF电极相连的RF能源。
18.根据权利要求12所述的仪器,它还包括与电极相连的冷却设备。
19.根据权利要求18所述的仪器,它还包括与冷却设备相连的流速控制装置,该装置的构造适合控制流经冷却设备的冷却液的流速。
20.根据权利要求12所述的仪器,它还包括至少部分包围在电极外的绝缘材料。
21.根据权利要求12所述的仪器,它还包括与电极相连的传感器。
22.根据权利要求12所述的仪器,它还包括位于电极末端的传感器。
23.根据权利要求12所述的仪器,它还包括与电极相连的反馈控制装置,传感器和RF能源。
24.根据权利要求12所述的仪器,它还包括与电极相连的灌注液来源。
25.根据权利要求12所述的仪器,其中的电极有一端从手柄外延伸至悬雍垂内的伸进长度,该伸进长度足以使得能力传送表面定位于选定的部位并传送足够的能量造成细胞坏死,同时减少外黏膜表面的细胞坏死。
26.一种用于缩小鼻甲结构内选定部位体积的细胞坏死仪,它包括:
手柄;
与手柄末端连接的电极,具有刺入组织的末端,电极的构造适于在鼻腔内灵活操纵,以刺入鼻甲结构表面,进入鼻甲结构足够深度到达组织部位,向该组织部位传送电磁能,造成受控的细胞坏死以扩大鼻通道,但不限制血液流向视神经和/或视网膜而造成永久性视力损伤;和
与电极相连的电线。
27.根据权利要求26所述的仪器,其中的电极造成受控的细胞坏死但不造成永久性嗅觉障碍。
28.根据权利要求26所述的仪器,其中的电极造成受控的黏膜层细胞坏死但不造成永久性鼻干。
29.根据权利要求26所述的仪器,其中的电极造成受控的黏膜层细胞坏死但不造成永久性萎缩性鼻炎。
30.根据权利要求26所述的仪器,其中的电极造成受控的黏膜层细胞坏死但不造成永久性睫状功能丧失。
31.根据权利要求26所述的仪器,其中的电极是RF电极。
32.根据权利要求30所述的仪器,它还包括与RF电极相连的RF能源。
33.根据权利要求26所述的仪器,它还包括与电极相连的冷却设备。
34.根据权利要求26所述的仪器,它还包括与冷却设备相连的流速控制装置,该装置的构造适合控制流经冷却装置的冷却液的流速。
35.根据权利要求26所述的仪器,它还包括至少部分包围在电极外的绝缘材料。
36.根据权利要求26所述的仪器,它还包括与电极相连的传感器。
37.根据权利要求26所述的仪器,它还包括位于电极末端的传感器。
38.根据权利要求26所述的仪器,它还包括与电极相连的反馈控制装置,传感器和RF能源。
39.根据权利要求26所述的仪器,它还包括与电极相连的灌注液来源。
40.根据权利要求26所述的仪器,其中的电极有一端从手柄外延伸至鼻甲结构内的伸进长度,该伸进长度足以使得能力传送表面定位于选定的部位并传送足够的能量造成鼻甲骨黏膜表面受控的细胞坏死,同时保留足量的鼻甲骨并避免造成永久性鼻干。
41.一种用于缩小软腭结构内选定部位体积的细胞坏死仪,它包括:
手柄;
与手柄末端连接的电极,具有刺入组织的末端,电极的构造适于在口腔内灵活操纵,以刺入软腭结构表面,进入软腭足够深度到达组织部位,向该组织部位传送电磁能,造成受控的细胞坏死并矫正软腭结构在口腔内的位置,并减少软腭结构外黏膜表面的坏死;和
与电极相连的电线。
42.根据权利要求41所述的仪器,其中的电极构造适合造成受控的细胞坏死并收紧软腭组织以矫正其位置。
43.根据权利要求41所述的仪器,其中的电极构造适合造成受控的细胞坏死并矫正软腭组织的形状以矫正其位置。
44.根据权利要求41所述的仪器,其中的电极是RF电极。
45.根据权利要求44所述的仪器,它还包括与RF电极相连的RF能源。
46.根据权利要求41所述的仪器,它还包括与电极相连的冷却设备。
47.根据权利要求46所述的仪器,它还包括与冷却设备相连的流速控制装置,该装置的构造适合控制流经冷却装置的冷却液的流速。
48.根据权利要求41所述的仪器,它还包括至少部分包围在电极外的绝缘材料。
49.根据权利要求41所述的仪器,它还包括与电极相连的传感器。
50.根据权利要求41所述的仪器,它还包括位于电极末端的传感器。
51.根据权利要求41所述的仪器,它还包括与电极相连的反馈控制装置,传感器和RF能源。
52.根据权利要求41所述的仪器,它还包括与电极相连的灌注液来源。
53.根据权利要求41所述的仪器,其中的电极有一端从手柄外伸至软腭结构内的伸进长度,该伸进长度足以使得能力传送表面定位于选定的部位并传送足够的能量造成细胞坏死,同时减少软腭结构外黏膜表面的坏死。
54.一种用于缩小鼻甲结构内选定部位体积的细胞坏死仪,它包括:
手柄;
与手柄末端连接的电极,具有刺入组织的末端,电极的构造适于在鼻腔内灵活操纵,以刺入鼻甲结构外表面,进入鼻甲结构足够深度到达组织部位,向该组织部位传送电磁能,造成受控的细胞坏死以扩大鼻通道,但不限制血液流向视神经和/或视网膜而造成永久性视力损伤;和
与电极相连的电线。
55.根据权利要求54所述的仪器,其中的电极造成受控的细胞坏死但不造成永久性嗅觉障碍。
56.根据权利要求54所述的仪器,其中的电极造成黏膜层受控的细胞坏死但不造成永久性鼻干。
57.根据权利要求54所述的仪器,其中的电极造成黏膜层受控的细胞坏死但不造成永久性萎缩性鼻炎。
58.根据权利要求54所述的仪器,其中的电极造成黏膜层受控的细胞坏死但不造成永久性睫状功能丧失。
59.根据权利要求54所述的仪器,其中的电极是RF电极。
60.根据权利要求59所述的仪器,它还包括与RF电极相连的RF能源。
61.根据权利要求54所述的仪器,它还包括与电极相连的冷却设备。
62.根据权利要求54所述的仪器,它还包括至少部分包围在电极外的绝缘机构。
63.根据权利要求54所述的仪器,它还包括与电极相连的传感器。
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US08/905,991 | 1997-08-05 | ||
US08/905,991 US5843021A (en) | 1994-05-09 | 1997-08-05 | Cell necrosis apparatus |
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EP (1) | EP1001710B1 (zh) |
JP (1) | JP2001513356A (zh) |
CN (1) | CN1272776A (zh) |
AT (1) | ATE286679T1 (zh) |
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CA (1) | CA2299362A1 (zh) |
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1997
- 1997-08-05 US US08/905,991 patent/US5843021A/en not_active Expired - Lifetime
-
1998
- 1998-05-28 US US09/085,741 patent/US6179803B1/en not_active Expired - Lifetime
- 1998-06-03 AT AT98926205T patent/ATE286679T1/de not_active IP Right Cessation
- 1998-06-03 ES ES98926205T patent/ES2235333T3/es not_active Expired - Lifetime
- 1998-06-03 AU AU78099/98A patent/AU732000B2/en not_active Expired
- 1998-06-03 CN CN98809791A patent/CN1272776A/zh active Pending
- 1998-06-03 WO PCT/US1998/011337 patent/WO1999007299A1/en active IP Right Grant
- 1998-06-03 CA CA002299362A patent/CA2299362A1/en not_active Abandoned
- 1998-06-03 EP EP98926205A patent/EP1001710B1/en not_active Expired - Lifetime
- 1998-06-03 JP JP2000506897A patent/JP2001513356A/ja not_active Abandoned
- 1998-06-03 DE DE69828617T patent/DE69828617T2/de not_active Expired - Fee Related
- 1998-07-10 US US09/113,744 patent/US6210355B1/en not_active Expired - Lifetime
-
1999
- 1999-06-09 US US09/328,686 patent/US6416491B1/en not_active Expired - Lifetime
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110290767A (zh) * | 2016-12-22 | 2019-09-27 | 艾琳医药股份有限公司 | 软腭治疗 |
CN107981928A (zh) * | 2017-12-06 | 2018-05-04 | 北京博海康源医疗器械有限公司 | 一种消融电极温度控制装置及其消融电极温度控制方法 |
Also Published As
Publication number | Publication date |
---|---|
US6210355B1 (en) | 2001-04-03 |
US6179803B1 (en) | 2001-01-30 |
JP2001513356A (ja) | 2001-09-04 |
ES2235333T3 (es) | 2005-07-01 |
CA2299362A1 (en) | 1999-02-18 |
DE69828617D1 (de) | 2005-02-17 |
EP1001710B1 (en) | 2005-01-12 |
US5843021A (en) | 1998-12-01 |
WO1999007299A1 (en) | 1999-02-18 |
DE69828617T2 (de) | 2006-01-05 |
US6416491B1 (en) | 2002-07-09 |
ATE286679T1 (de) | 2005-01-15 |
EP1001710A1 (en) | 2000-05-24 |
AU7809998A (en) | 1999-03-01 |
AU732000B2 (en) | 2001-04-12 |
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