CN1627923A - 用于组织的rf治疗的机头 - Google Patents

用于组织的rf治疗的机头 Download PDF

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CN1627923A
CN1627923A CNA038034026A CN03803402A CN1627923A CN 1627923 A CN1627923 A CN 1627923A CN A038034026 A CNA038034026 A CN A038034026A CN 03803402 A CN03803402 A CN 03803402A CN 1627923 A CN1627923 A CN 1627923A
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electrode
cooling fluid
fluid medium
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罗杰·斯特恩
米切尔·莱文森
布赖恩·威伯
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Solta Medical Inc
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Thermage Inc
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    • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure

Abstract

该机头包括机头组件、机头壳体和冷却流体介质阀部件。电极组件与机头壳体连接。电极组件有至少一个RF电极，当RF电极的至少一部分与皮肤表面接触时，该RF电极与皮肤表面电容耦合。

Description

用于组织的RF治疗的机头
相关申请的交叉引用
本申请是US系列No.09/522275的部分延续，该申请No.09/522275的申请日为2000年3月9日，它要求美国申请No.60/123440的优先权，该美国申请No,60/123440的申请日为1999年3月9日，这两篇文献都完全被本文参引。
技术领域
本发明通常涉及一种用于治疗组织的机头，尤其是涉及一种用于治疗皮肤和底层组织的RF电极机头。
背景技术
人体皮肤包括两个部分：表皮和底层真皮。具有角质层的表皮作为对于外部环境的生物屏障。在表皮的基底层中，存在称为黑素细胞的色素形成细胞。它们是皮肤颜色的决定因素。
底层真皮提供了皮肤的主结构支承。它主要包括称为胶原蛋白的细胞外蛋白质。胶原蛋白由纤维原细胞生成，并合成为具有三个多肽链的三股螺旋，这三个多肽链通过热不稳定和热稳定化学键来连接。当包含胶原蛋白的组织加热时，在特征温度下，蛋白质基质的物理特性将发生变化。在特定“收缩”温度下，发生胶原蛋白收缩的结构过渡。胶原蛋白基质通过加热而收缩和改造是该技术基础。
胶原蛋白交联是分子内的(共价键或氢键)或分子间的(共价键或离子键)。分子内氢交联的热断裂是标量处理(scalar process)，它通过断裂事件和松弛(relaxation)事件(氢键的重新形成)之间的平衡而产生。进行该处理不需要外力。因此，通过分子内氢键的热断裂而产生分子间应力。特别是，分子的三级结构收缩产生了初始的分子间收缩矢量。
基质中的胶原蛋白细纤维有各种空间方向。当全部矢量的和作用成使细纤维分散时，基质被拉长。当全部矢量的和作用成使细纤维缩短时，将有利于基质收缩。分子内氢键的热打开和分子间交联的机械断裂也受到返回原有结构的松弛事件的影响。不过，当在胶原蛋白细纤维拉长或收缩之后重新形成交联时，分子长度发生永久性变化。连续施加外部机械力将增加在使纤维拉长或收缩后形成交联的可能性。
氢键断裂是量子机械事件，它需要临界值的能量。所需的(分子内)氢键断裂量与胶原蛋白细纤维中的组合离子和共价分子间键强度相对应。在达到该临界值之前胶原蛋白细纤维的四级结构将发生很小变化或者不发生变化。当分子间应力足够时，将发生离子和共价键的断裂。通常，通过在拉长或收缩细纤维中的极性和非极性区域的重新对齐引起的棘轮效应而使分子间的离子和共价键断裂。
胶原蛋白键的断裂也在低温时发生，但是在低速下。低水平的热断裂通常与松弛现象相关，在松弛现象中，在分子长度没有净变化的情况下重新形成键。使细纤维机械断裂的外力将减小松弛现象的可能性，并提供了在低温下拉长或缩短胶原蛋白细基质，同时减小潜在的皮肤切除的方式。
软组织再造是在细胞和分子水平发生的生物现象。胶原蛋白的分子收缩或局部变性涉及施加能量源，该能量源通过使三股螺旋的热不稳定键断裂而使得分子的纵向轴线不稳定。因此，将产生应力以便断开基质的分子间键。这是基本即时的细胞外处理，而细胞收缩需要一段滞后时间，以便使纤维原细胞进入伤口内并倍增，与伤口愈合顺序相同。在进化程度较高的动物种类中，对受伤的伤口治愈响应包括最初的发炎过程，随后导致疤痕组织的沉积。
最初的发炎响应包括处理细胞碎屑的白血球或白细胞渗入。72小时后，在受伤部位出现纤维原细胞的增殖。这些细胞分化成收缩的成肌纤维细胞，该成肌纤维细胞是细胞软组织收缩源。在细胞收缩后，胶原蛋白作为静止支承基质布置在拉紧的软组织结构中。该初生疤痕基质的沉积和随后的再造提供了改变软组织的松紧度和几何形状的方式，以便用于美容目的。
通过前述说明，有多种适于进行治疗的皮肤病处理方法，它们将热能传送给皮肤和底层组织，以便引起胶原蛋白收缩和/或引起伤口治愈响应。该处理包括皮肤改造/表面重修、去除皱纹、以及皮脂腺、毛囊脂肪组织和蜘蛛静脉(spider vein)的治疗。目前可用于将热能传递给皮肤和底层组织的技术包括射频(RF)、光(激光)和其它形式的电磁能。不过，这些技术有技术限制和临床问题，这限制了治疗的效果和/或不能治疗。该问题包括：i)在较大组织区域上获得均匀的热效果；ii)控制对目标选定组织的热效果的深度，并防止对目标和非目标组织的不希望热损害；iii)减小不利组织效果，例如烧伤、起红泡；iv)用更连续的传送治疗(例如通过滑动或涂抹运动)来代替以拼凑(patchwork)方式进行的传送能量/治疗；v)更好地接近皮肤表面的难以到达区域；以及vi)减少完成治疗所需的病人就诊的处理时间和次数。如本文所述，本发明提供了用于解决这些和其它限制的装置。
目前可用于治疗皮肤的RF技术的一个关键缺点是边缘效应现象。通常，当RF能量通过与组织接触的电极而施加或传送给组织时，电流图形集中在电极的边缘周围，特别是尖锐边缘的周围。该效应通常称为边缘效应。当为圆盘电极时，该效应表现为在圆盘的周边处的电流密度更高，而在中心处的电流密度相对较低。对于方形电极，通常在整个周边处的电流密度很高，且在尖锐边缘处的拐角处有甚至更高的电流密度。
边缘效应由于各种原因而引起皮肤治疗的问题。首先，它们导致在电极表面上的不均匀热效果。在皮肤的各种治疗中，重要的是在相对较大的表面区域上有均匀的热效果，特别是对于皮肤病治疗区域。这时，较大是大约几平方毫米或者甚至几平方厘米。在用于切割组织的电外科学用途中，通常有点形施加器，它的设计目的是在用于切割或者甚至凝固组织的点处形成热点。不过，该点设计并不适于在较大表面区域上产生相对柔和的热效果。需要将电极设计成在没有热点的情况下将均匀的热能传递给皮肤和底层组织。
当在皮肤/组织治疗处理中冷却与加热组合时，均匀热效果特别重要。如下面所述，非均匀热图形使得皮肤的冷却困难，因此导致治疗处理也困难。当用RF能量对皮肤进行加热时，在电极表面处的组织将最热，同时随着进入组织越深而温度越低。用于克服该热梯度并在离电极设定距离处产生热效果的一种方法是冷却与电极接触的皮肤层。不过，当没有均匀加热图形时，皮肤的冷却变得困难。当皮肤充分冷却，从而在方形或矩形电极的拐角处或者在圆盘电极的周边处没有烧伤时，可能在中心处过冷，且在电极的中心之下将没有足够的热效果(即组织加热)。相反，当冷却效果减小至使得电极的中心处有良好热效果时，也许并不能充分冷却成保护与电极边缘接触的组织。由于这些限制，在标准电极的普通用途中，通常有非均匀治疗区域和/或对皮肤表面的烧伤。因此，加热图形的均匀性非常重要。在对包含胶原蛋白的层进行加热以便响应皮肤的拉紧产生胶原蛋白收缩的治疗皮肤用途中，这特别重要。对于该用途和相关用途，当胶原蛋白收缩和导致皮肤拉紧效果不均匀时，可能产生医学上不希望的结果。
因此需要用于美容用途的改进RF机头。
发明内容
因此，本发明的目的是提供一种RF机头，它将能量基本均匀地传送给目标组织部位。
本发明的另一目的是提供一种RF机头，该RF机头包括至少一个RF电极，当RF电极的至少一部分与皮肤表面接触时，该RF电极能够与皮肤表面电容耦合。
本发明的另一目的是提供一种RF机头，该RF机头在选定深度的组织中提供均匀的热效果，同时防止或减小对皮肤表面和其它非目标组织的热损害。
本发明的另一目的是提供一种RF机头，该RF机头设置成减少或消除RF电极施加给皮肤表面的边缘效应和热点。
本发明的另一目的是提供一种RF机头，该RF机头设置成将冷却流体介质雾化传送给RF电极。
本发明还有一目的是提供一种RF机头，该RF机头设置成蒸发冷却RF电极的后表面，并传导性地冷却与RF电极的前表面相邻的皮肤表面。
本发明的另一目的是提供一种RF机头，该RF机头设置成在RF电极的前表面相对于重力方向为任意方向的情况下都可控制地将冷却流体介质传送给RF电极的后表面。
本发明的另一目的是提供一种RF机头，该RF机头包括具有导电部分和电介质部分的RF电极。
本发明的另一目的是提供一种RF机头，该RF机头包括力传感器，在RF电极的前表面相对于重力方向为任意方向的情况下，该力传感器都使得由RF机头的电极组件的重量产生的重力效果为零。
本发明的这些和其它目的可以通过一种有机头组件的机头来实现。该机头组件包括机头壳体和冷却流体介质阀部件。电极组件与机头壳体连接。电极组件有至少一个RF电极，当RF电极的至少一部分与皮肤表面接触时，该RF电极与皮肤表面电容耦合。
在本发明另一实施例的机头中，机头组件包括机头壳体以及具有进口和出口的冷却流体介质阀部件。电极组件可拆卸地与机头壳体连接。电极组件有至少一个RF电极，该RF电极有前表面和后表面。当RF电极的至少一部分与皮肤表面接触时，该RF电极与皮肤表面电容耦合。
在本发明的另一实施例中，机头包括具有机头壳体的机头组件。插入件可至少部分位于机头壳体内。RF电极与插入件连接。RF电极有对着机头壳体的后表面以及相对的前表面。冷却流体介质分配组件与该机头壳体和插入件连接。
在本发明的另一实施例中，机头包括具有机头壳体的机头组件。插入件可拆卸地与机头壳体连接。插入件包括具有导电部分和电介质部分的RF电极。
在本发明的另一实施例中，机头包括具有机头壳体的机头组件。插入件可拆卸地与机头壳体连接。RF电极位于插入件内。RF电极包括柔性电路。
在本发明的另一实施例中，机头包括具有机头壳体的机头组件。插入件可拆卸地与机头壳体连接。插入件包括柔性电路以及具有导电部分和电介质部分的RF电极。
附图的简要说明
图1是本发明的机头的一个实施例的剖视图。
图2是图1的插入件组件的分解透视图。
图3是本发明的RF电极的一个实施例的局部放大图。
图4是图1的机头壳体部分的另一剖视图。
图5是图1的插入件的剖视图。
具体实施方式
下面参考图1，本发明的一个实施例是具有机头组件12的机头10。机头组件12包括机头壳体14和冷却流体介质阀部件16。电极组件18与机头壳体14连接。电极组件18有至少一个RF电极20，当RF电极20的至少一部分与皮肤表面接触时，该RF电极20与皮肤表面电容性耦合。在不限制本发明范围的情况下，RF电极20的厚度在0.010至1.0mm的范围内。
机头10在选定深度的组织中提供了更均匀的热效果，同时防止或减小了对皮肤表面和其它非目标组织的热损害。机头10与RF电发生器连接。RF电极20可以以单极或双极模式操作。机头10设置成减小(或者优选是消除)边缘效应和热点。这使得在消除/减小不利效果和治疗时间的情况下改善美容结果/临床效果。
流体传送部件22与冷却流体介质阀部件16连接。流体传送部件22和冷却流体介质阀部件16一起形成冷却流体介质分配组件。流体传送部件16设置成使冷却流体介质雾化传送给RF电极20。雾化传送是雾或细喷雾。当冷却流体介质撞上RF电极20的表面时，它发生从液体至气体的相变。从液体至气体的相变产生冷却。当在冷却流体介质撞上RF电极20之前发生相变时，RF电极20的冷却将不会这么有效。
在一个实施例中，冷却流体介质是致冷剂喷雾，可从Honeywell，Morristown，New Jersey购得。合适的致冷剂喷雾的特殊实例是R134A2，可由Refron，Inc.，38-1833rdSt，Long Island City，New York11101购得。致冷剂冷却流体介质的使用导致能够采用多种不同类型的皮肤治疗方法。例如，致冷剂冷却流体介质可以在RF能量传送给合适组织之前和之后几毫秒施加。这可以通过使用与致冷剂源连接的冷却流体介质阀部件16而实现，该致冷剂源包括但不局限于压缩气罐。在不同实施例中，冷却流体介质阀部件16可以与计算机控制系统连接，和/或通过脚踏开关或类似装置而由医师人工控制。
提供致冷剂冷却流体介质的喷雾或雾化的主要优点是能够快速进行开关控制。致冷剂冷却流体介质能够对冷却处理进行更精确的时间控制。这是因为只有当致冷剂进行喷射并处于蒸发状态时才发生冷却，而蒸发是非常快的短时间事件。因此，冷却将在停止致冷剂冷却流体介质之后快速停止。总体效果能够对致冷剂冷却流体介质进行非常精确时间的on-off控制。
下面参考图2，流体传送部件22可以位于机头壳体14或电极组件18内。流体传送部件22设置成将冷却流体介质可控制地传送给RF电极20的后表面24，并使后表面24保持合适温度。冷却流体介质蒸发冷却RF电极20，并使RF电极20的前表面26保持基本均匀的温度。前表面26可具有足够的柔性并与皮肤相符，但是也有足够强度和/或结构，以便当压靠皮肤表面时提供良好的热耦合。
然后，RF电极20传导性地冷却靠近RF电极20前表面26的皮肤表面。合适的流体介质包括各种致冷剂例如R134A和氟利昂。流体传送部件22设置成在前表面26相对于重力方向为基本任何方向时将冷却流体介质可控制地传送给后表面24。流体传送部件22的几何形状和位置选择为使冷却流体介质基本均匀地分布在后表面24上。冷却流体介质的传送可以通过喷射液滴或细雾进行，从而充满后表面24等。在冷却流体介质与大气的交界面处产生冷却，在该交界面处产生蒸发。当在后表面24上有较厚流体层时，从治疗皮肤除去的热量需要穿过该较厚冷却流体介质层，从而增加了热阻。为了使冷却速度最大，希望施加非常薄的冷却流体介质层。当RF电极20并不水平时，以及当有较厚冷却流体介质层时，或者当在后表面24上有较大冷却流体介质液滴时，冷却流体介质可能从RF电极20表面流下，并汇集在一个边缘或拐角处，从而引起非均匀冷却。因此，优选是通过细喷雾施加较薄的冷却流体介质层。
在不同实施例中，如图3中所示，RF电极20有导电部分28和电介质部分30。导电部分28可以为金属，该金属包括但不局限于：铜、金、银、铝等。电介质部分30可以有各种不同材料制成，这些材料包括但不局限于聚酰亚胺等。其它电介质材料包括但不局限于：硅酮、蓝宝石、金刚石、锆增强氧化铝(ZTA)、氧化铝等。电介质部分30可以布置在导电部分28的至少一部分或者整个外周。用于电介质部分30的合适材料包括但不局限于：Teflon等、氮化硅、聚硅烷、聚硅氨烷、聚酰亚胺、高温聚酰亚胺薄膜(Kapton)和其它聚合物、天线电介质和本领域公知的其它电介质材料。在另一实施例中，RF电极20由复合材料制成，该复合材料包括但不局限于：镀金铜、铜-聚酰亚胺、硅/氮化硅等。
电介质部分30对于流过RF电极20的电流产生增大阻抗。该增大阻抗使得电流沿通过导电部分28的直通路向下通向皮肤表面。因此可以减小由于流出RF电极20的边缘的电流的集中而引起的电场边缘效应。
电介质部分30产生了通过RF电极20的更均匀阻抗，并使得更均匀的电流流过导电部分28。所形成的效果减小或者甚至消除了在RF电极20的边缘周围的边缘效应。
在一个实施例中，导电部分28粘接在电介质部分30上，该电介质部分30可以是厚度为大约0.001″(作为非限定实例)的基质。本实施例与可由电子元件工厂购得的标准柔性电路板材料类似。在本实施例中，电介质部分30与组织(皮肤)接触，而导电部分28与皮肤分离。可以通过利用各种技术使导电部分28在电介质部分30上生长而减小电介质部分30的厚度，这些技术包括但不局限于：溅射、电沉积、化学蒸气沉积、等离子体沉积和本领域已知的其它沉积技术。此外，这些相同处理可以用于将电介质部分30沉积在导电部分28上。在一个实施例中，电介质部分30是可以在导电部分28上生长的氧化物层。氧化物层具有较低热阻，与其它电介质例如聚合物相比提高了皮肤的冷却效率。
流体传送部件22有进口32和出口34。出口34的截面面积可以比进口32的截面面积更小。在一个实施例中，流体传送部件22为喷嘴36。
冷却流体介质阀部件16可以设置成提供冷却流体介质的脉冲传送。使冷却流体介质脉冲传送是一种控制冷却流体介质施加速度的简单方式。在一个实施例中，冷却流体介质阀部件16是电磁阀。合适电磁阀的实例是由N-Research Corporation，West Caldwell，NJ制造的电磁夹阀。当使流体增压时，阀开口使得流体流出。当流体保持恒定压力时，流量恒定，并可以使用简单的打开/关闭电磁阀，有效流量由脉冲工作循环来确定。更高工作循环(靠近100％)将增加冷却，而更低工作循环(靠近0％)将减小冷却。工作循环可以通过以设定频率打开阀持续较短时间而获得。打开持续时间可以为1至50毫秒或更长。脉冲的频率可以为1至50Hz或更快。
也可选择，冷却流体介质流量可以通过计量阀或可控流量泵例如蠕动泵来控制。脉冲的一个优点是它很容易利用简单的电子控制方法来控制。
电极组件18充分密封，这样，冷却流体介质不会从后表面24泄漏到与RF电极20的前表面接触的皮肤表面上。这有助于使通过皮肤表面传送的能量均匀。在一个实施例中，电极组件18(更具体地说RF电极20)的几何形状为在后表面24上产生储存器，以便保持和收集已经集中在后表面24上的冷却流体介质。后表面24可以形成有“医院床单折角(hospital corner)”，以便产生该储存器。也可选择，电极组件18包括通风孔38，该通风孔38允许蒸发的冷却流体介质从电极组件18中逸出。这减小了冷却流体介质集中在后表面24上的机会。当冷却流体介质以蒸气形式传送给后表面24，且在冷却了后表面24之后蒸气冷凝成液体时，可能发生冷却流体介质集中在后表面上的情况。
通风孔38防止压力在电极组件18中积累。通风孔38可以是通向大气或通风管路的压力安全阀。当冷却流体介质与RF电极20接触并蒸发时，所形成的气体使电极组件18内部增压，这可能使RF电极20局部膨胀并从前表面26向外鼓出。膨胀的RF电极20可以增强与皮肤的热接触，还在一定程度上使得RF电极20与皮肤表面相符。可以提供电子控制器。当达到程序设定压力时，该电子控制器发送信号以便打开通风孔38。
各个引线40与RF电极20连接。一个或多个热传感器42与RF电极连接。合适的热传感器42包括但不局限于：热电偶、热敏电阻、红外光电发射器以及热敏二极管。在一个实施例中，热传感器42布置在RF电极20的各个拐角处。提供有足够数目的热传感器42，以便获得足够的皮肤表面热数据。热传感器42与RF电极20电绝缘。
热传感器42测量温度，并能够在治疗过程中提供RF电极20和/或组织的监测温度的反馈。热传感器42可以是热敏电阻、热电偶、热敏二极管、电容器、电感器或其它用于测量温度的装置。优选是，热传感器42向与RF电极20连接的RF发生器的微处理器提供电子反馈以便实施治疗控制。
来自热传感器42的测量值可以用于帮助控制冷却流体介质的施加量。例如，冷却控制算法可以用于以很高流量向RF电极20施加冷却流体介质，直到温度降低至低于目标温度，然后缓慢降低或停止。PID或比例-积分-微分算法可以用于将RF电极20的温度精确控制为预定值。
热传感器42可以布置在RF电极20的、远离组织的后表面24上。该结构能够很理想地控制RF电极20的温度。也可选择，热传感器42可以位于RF电极10的、直接与组织接触的前表面26上。该实施例更适于监测组织温度。利用热传感器42的算法可以用于计算治疗组织的温度型面。热传感器42可以用于形成皮肤的温度型面，然后，该温度型面再用于处理控制目的，以便保证传送合适的加热和冷却量，从而获得合适的深层组织温升，同时保持皮肤组织层低于界限温度，并避免热伤害。医师可以利用测量的温度型面来确认他仍然在给定类型治疗的理想/平均型面的边界内。热传感器42可以用于附加目的。当监测热传感器42的温度时，可以检测RF电极20与皮肤表面接触的时间。这可以通过检测当与皮肤接触时的瞬时温度变化而获得，或者通过检查与皮肤接触对温度变化率的影响而获得。同样，当有多个热传感器42时，热传感器42可以用于检测RF电极20的一部分是否升高或脱离皮肤。这可能很重要，因为当接触面积变化时，传送给皮肤的电流密度(安培每单位面积)可能改变。特别是，当RF电极20的部分表面不与皮肤接触时，所形成的电流密度高于预期。
下面参考图4，力传感器44也与电极组件18连接。力传感器44检测经医师通过电极组件18对被施加的皮肤表面施加的力的大小。在RF电极20的前表面26相对于重力方向为任何方向的情况下，力传感器44都使电极组件18的重力效果为零。另外，当RF电极20与皮肤表面接触时，力传感器44提供指示。力传感器44还提供表示由RF电极20施加给接触皮肤表面的力(i)低于最小界限值或者(ii)高于最大界限值的信号。
驱动按钮46与力传感器结合使用。恰好在驱动RF电极20之前，医师使机头10保持在恰好离开皮肤表面的位置。机头10的方向可以相对于重力方向为任何角度。为了起动机头10，医师可以按下驱动按钮46，这通过将力传感器44设置成读数为零而修正力传感器。这消除了在该特定治疗方向下由于重力产生的力。该方法还使得不管机头10相对于重力方向的角度如何，都使得RF电极20施加给皮肤表面的力一致。
RF电极20可以是包括痕量组分的柔性电路。另外，热传感器42和力传感器44可以是该柔性电路的一部分。而且，柔性电路可以包括电介质，该电介质形成RF电极20的一部分。
电极组件18可以活动布置在机头壳体12中。在一个实施例中，电极组件18可沿机头壳体12的纵向轴线滑动。电极组件18可旋转地安装在机头壳体12中。另外，RF电极20可旋转地位于电极组件18内。电极组件18作为一次性或非一次性的插入件52而可拆卸地与机头壳体12连接，见图5。这说明，电极组件18与插入件52相同。一旦可运动地安装在机头壳体12上，插入件52可以通过力传感器44而与机头壳体12连接。力传感器44可以是能够测量压缩和拉伸力的类型。在其它实施例中，力传感器44只测量压缩力，或者只测量拉伸力。
插入件52可以通过弹簧48而加载有弹簧负载。在一个实施例中，弹簧48沿朝着机头壳体12的方向偏压RF电极20。这使得力传感器44受到预负载，并使插入件52保持压靠力传感器44。当恰好在RF电极20施加给皮肤表面之前按下驱动按钮46时，预负载力得到修正。
罩50与机头选择连接。罩50用于在使用时防止用户接触插入件52，而这种接触会导致错误的力读出值。
插入件52可以包括永久性存储器54。另外，机头壳体12可以包括永久性存储器。永久性存储器54可以是EPROM等。此外，第二永久性存储器56可以包含于机头壳体12中，用于储存机头10信息，该信息例如但不局限于：机头型号或型式、机头软件版本、机头10已经传送的RF使用数目、有效期和制造日期。机头壳体12还可以包含微处理器58，用于获取和分析来自机头壳体12或插入件52上的各个传感器的数据，这些传感器包括但不局限于：热传感器42、力传感器44、流体压力计、开关、按钮等。微处理器58还可以控制机头10的部件，这些部件包括但不局限于：灯、LED、阀、泵或其它电子部件。微处理器还可以将数据传输给RF发生器的微处理器。
永久性存储器54可以储存有利于机头10以及它的相关系统的控制和操作的各种数据，该控制和操作包括：(i)控制由RF电极20传送的电流量；(ii)控制流体传送部件22的工作循环；(iii)控制RF电极20的能量传送持续时间；(iv)相对目标温度控制RF电极20的温度；(v)提供RF电极20的最大发射次数；(vi)提供可由RF电极20传送的最大允许电压；(vii)提供RF电极20的使用历史；(viii)向流体传送部件22提供可控制工作循环，用于将冷却流体介质传送给RF电极20的后表面24上；(ix)将由流体传送部件22传送的、可控制流量的冷却流体介质提供给后表面24等。
机头10可以用于传送热能以便改变在表皮、真皮和皮下组织(包括脂肪组织)中的组织，该组织包括但不局限于：包含组织的胶原蛋白。组织的变化包括改变组织的物理性质、组织的结构或组织的物理特征。该改变可以通过传送足够能量以便使胶原蛋白收缩而实现，和/或通过伤口愈合响应而实现，该伤口愈合响应包括新的或初生胶原蛋白的沉积。
机头10可以用于执行皮肤和底层组织的多个处理，这些处理包括但不局限于：(i)真皮改造和拉紧；(ii)减少皱纹；(iii)减少弹性组织变性；(iv)皮脂腺去除/灭活；(v)毛囊去除；(vi)脂肪组织改造/去除；(vii)蜘蛛静脉去除等。
在不同实施例中，机头10可以用于各种治疗处理，这些治疗处理包括但不局限于：(i)在开始将能量传送给组织之前进行预冷却；(ii)运行阶段或能量传送阶段结合冷却；(iii)在停止将能量传送给组织之后进行后冷却。
机头10可以用于预冷却目标组织的表面层，这样，当RF电极20与组织接触时，或者在打开RF电源之前，目标组织的表面层已经冷却。当开始将RF能量源打开或将RF以其它方式传送给组织，从而导致组织的加热时，已经冷却的组织将防止包括热损害的热效应。没有冷却的组织将加热至治疗温度，从而导致合适的治疗效果。
预冷却产生了用于冷却热效应的时间，以便能向下传播到组织内。更具体地说，预冷却能够获得所希望的组织深度热型面，同时在选定深度获得最小合适温度。预冷却的量或持续时间可以用于选择未治疗组织的保护区域的深度。预冷却的持续时间越长，将产生更深的保护区，因此开始治疗的区域在组织中的更深处。使预冷却的持续时间更短则出现相反情况。RF电极20的前表面26的温度也影响温度型面。前表面26的温度越冷，冷却将越快和越深，反之亦然。
后冷却可能很重要，因为它防止和/或减少传送给更深层的热量向上传导和可能将更浅层加热至治疗或损害温度范围(尽管已经停止将外部能量传送给组织)。为了防止该相关热现象，优选是在停止施加RF能量之后仍然保持冷却治疗表面一定时间。在不同实施例中，不同量的后冷却可以与实时冷却和/或预冷却组合。
在不同实施例中，机头10可以用于不同的脉冲on-off类型冷却顺序，并可以采用不同方法。在一个实施例中，该治疗方法用于通过起动致冷剂冷却流体介质喷雾而预冷却组织，随后将短脉冲RF能量施加到组织中。在本实施例中，持续进行致冷剂冷却流体介质的喷射，同时传送RF能量，然后短时间停止，例如几微秒。该治疗顺序或其它治疗顺序可以再次重复。因此，在不同实施例中，治疗顺序可以包括冷却打开、加热、冷却关闭、冷却打开、加热、冷却关闭的脉冲顺序，且冷却和加热持续时间为几十毫秒。在这些实施例中，每次冷却皮肤的组织表面，热量就从皮肤表面除去。致冷剂冷却流体介质喷射持续时间和喷射之间的间隔可以在几十毫秒的范围内，这能够使皮肤冷却，同时还将合适热效应传送至更深的目标组织中。
在不同实施例中，根据治疗类型，用于治疗的目标组织区域(也称为治疗区域或热效应区域)的组织深度可以从皮肤下面大约100μm至10毫秒深。对于包括胶原蛋白收缩的治疗，优选是冷却皮肤的表皮以及位于表皮下面的真皮表层，冷却深度范围在100μm至两毫米之间。不同的治疗方法可能包括不同量的预冷却、加热和后冷却阶段，以便在合适深度产生合适组织效果。
根据治疗类型，可以采用各种冷却和加热工作循环(on和off时间)。冷却和加热工作循环可以通过本领域已知的电子控制系统来控制和动态变化。特别是，控制系统可以用于控制冷却流体介质阀部件16和RF电源。
前述对本发明优选实施例的说明是为了解释和说明。并不是为了穷举或将本发明限制为所述确切形式。显然，本领域技术人员清楚多种变化和改变。本发明的范围将由下面的权利要求和它们的等效物来确定。

Claims (111)

1.一种RF装置，包括：
装置组件，该装置组件包括壳体和冷却流体介质阀部件；以及
电极组件，该电极组件与壳体连接，该电极组件包括至少一个RF电极，当RF电极的至少一部分与皮肤表面接触时，该RF电极与皮肤表面电容耦合。
2.根据权利要求1所述的RF装置，还包括：
流体传送部件，该流体传送部件与冷却流体介质阀部件连接，其中，该流体传送部件设置成向RF电极提供冷却流体介质的雾化传送。
3.根据权利要求2所述的RF装置，其中：该流体传送部件与RF电极壳体连接。
4.根据权利要求2所述的RF装置，其中：该流体传送部件位于电极组件内。
5.根据权利要求2所述的RF装置，其中：该流体传送部件包括喷嘴。
6.根据权利要求2所述的RF装置，其中：该流体传送部件设置成向RF电极传送可控制量的冷却流体介质。
7.根据权利要求2所述的RF装置，其中：该流体传送部件设置成可控制地将冷却流体介质传送给RF电极的后表面。
8.根据权利要求2所述的RF装置，其中：流体传送部件设置成可控制地将流体传送给RF电极的后侧，以便蒸发冷却RF电极和传导性地冷却与RF电极的前侧接触的皮肤表面。
9.根据权利要求2所述的RF装置，其中：该流体传送部件设置成在RF电极的前表面相对于重力方向基本为任何方向的情况下，都可控制地将冷却流体介质传送给RF电极。
10.根据权利要求1所述的RF装置，其中：电极组件被密封成足以使从RF电极的后表面流向与RF电极的前表面接触的皮肤表面的冷却流体介质减至最少。
11.根据权利要求1所述的RF装置，其中：该电极组件包括通风孔。
12.根据权利要求1所述的RF装置，其中：该冷却流体介质阀部件设置成提供冷却流体介质的脉冲传送。
13.根据权利要求1所述的RF装置，其中：该冷却流体介质阀部件包括电磁阀。
14.根据权利要求1所述的RF装置，其中：该RF电极包括导电部分和电介质部分。
15.根据权利要求14所述的RF装置，其中：该导电部分包括金属。
16.根据权利要求14所述的RF装置，其中：该导电部分包括铜。
17.根据权利要求14所述的RF装置，其中：该电介质部分包括聚酰亚胺。
18.根据权利要求14所述的RF装置，其中：该RF电极包括铜-聚酰亚胺复合材料。
19.根据权利要求1所述的RF装置，还包括：
引线，该引线与RF电极连接。
20.根据权利要求1所述的RF装置，还包括：
柔性电路，该柔性电路与RF电极连接。
21.根据权利要求20所述的RF装置，其中：该柔性电路设置成隔离从RF电极的后表面流向RF电极的前表面的冷却流体介质流。
22.根据权利要求20所述的RF装置，其中：该柔性电路设置成产生储存器，用于收集在RF电极后表面的冷却流体介质。
23.根据权利要求20所述的RF装置，其中：该柔性电路包括痕量组分。
24.根据权利要求20所述的RF装置，还包括：
力传感器，该力传感器与电介质连接。
25.根据权利要求20所述的RF装置，其中：该柔性电路包括热传感器。
26.根据权利要求20所述的RF装置，其中：该柔性电路包括电介质，该电介质形成RF电极的一部分。
27.根据权利要求1所述的RF装置，还包括：
力传感器，该力传感器与RF电极连接。
28.根据权利要求27所述的RF装置，其中：该力传感器设置成检测由RF电极对着皮肤施加的力的大小。
29.根据权利要求27所述的RF装置，其中：该力传感器设置成使电极组件的重量的重力效果为零。
30.根据权利要求27所述的RF装置，其中：该力传感器设置成在RF电极的前表面相对于重力方向为任何方向的情况下都使电极组件的重量的重力效果为零。
31.根据权利要求27所述的RF装置，其中：该力传感器设置成提供RF电极与皮肤表面接触的指示。
32.根据权利要求27所述的RF装置，其中：该力传感器设置成提供表示由RF电极施加给接触皮肤表面的力低于最小界限值的信号。
33.根据权利要求27所述的RF装置，其中：该力传感器设置成提供表示由RF电极施加给接触皮肤表面的力高于最大界限值的信号。
34.根据权利要求27所述的RF装置，还包括：
与力传感器相连的修正按钮。
35.根据权利要求1所述的RF装置，还包括：
弹簧，该弹簧与RF电极连接。
36.根据权利要求35所述的RF装置，其中：该弹簧进行预加负载。
37.根据权利要求35所述的RF装置，其中：该弹簧设置成沿朝着RF电极壳体的方向偏压RF电极。
38.根据权利要求1所述的RF装置，还包括：
罩，该罩与电极组件连接。
39.根据权利要求1所述的RF装置，还包括：
RF电极识别器。
40.根据权利要求1所述的RF装置，其中：RF电极包括导电部分以及电介质，该电介质布置成环绕导电部分的周边的至少一部分。
41.根据权利要求1所述的RF装置，其中：RF电极包括导电部分以及电介质，该电介质布置成环绕导电部分的整个周边。
42.根据权利要求1所述的RF装置，其中：该电极组件包括具有进口和出口的冷却流体介质槽道。
43.根据权利要求42所述的RF装置，其中：冷却流体介质槽道的出口的截面面积小于进口的截面面积。
44.根据权利要求1所述的RF装置，其中：该电极组件可在RF电极壳体的至少一部分内运动。
45.根据权利要求1所述的RF装置，其中：该电极组件可在RF电极壳体的至少一部分内滑动。
46.根据权利要求1所述的RF装置，其中：该电极组件可相对于RF电极壳体转动。
47.根据权利要求1所述的RF装置，其中：该RF电极可旋转地位于电极组件内。
48.根据权利要求1所述的RF装置，其中：该电极组件与处于静止位置的RF装置壳体连接。
49.一种RF装置，包括：
装置组件，该装置组件包括壳体以及具有进口和出口的冷却流体介质阀部件；以及
电极组件可拆卸地与装置组件连接，该电极组件有至少一个RF电极，该RF电极有前表面和后表面，其中，当RF电极的至少一部分与皮肤表面接触时，该RF电极与皮肤表面电容耦合。
50.根据权利要求49所述的RF装置，还包括：
流体传送部件，该流体传送部件与冷却流体介质阀部件连接，其中，该流体传送部件设置成向RF电极提供冷却流体介质的雾化传送。
51.根据权利要求50所述的RF装置，其中：该流体传送部件位于RF装置壳体内。
52.根据权利要求50所述的RF装置，其中：该流体传送部件位于电极组件内。
53.根据权利要求50所述的RF装置，其中：该流体传送部件包括喷嘴。
54.根据权利要求50所述的RF装置，其中：该流体传送部件设置成向RF电极传送可控制量的冷却流体介质。
55.根据权利要求50所述的RF装置，其中：该流体传送部件设置成可控制地将冷却流体介质传送给RF电极的后表面。
56.根据权利要求50所述的RF装置，其中：流体传送部件设置成可控制地将流体传送给RF电极的后侧，以便蒸发冷却RF电极和传导性地冷却与RF电极的前侧接触的皮肤表面。
57.根据权利要求50所述的RF装置，其中：在RF电极的前表面相对于重力方向基本为任何方向的情况下，该流体传送部件设置成可控制地将冷却流体介质传送给RF电极的后表面。
58.根据权利要求49所述的RF装置，其中：电极组件被密封成足以使从RF电极的后表面流向与RF电极的前表面接触的皮肤表面的冷却流体介质减至最少。
59.根据权利要求49所述的RF装置，其中：该电极组件包括通气孔。
60.根据权利要求49所述的RF装置，其中：该冷却流体介质阀部件设置成提供冷却流体介质的脉冲传送。
61.根据权利要求49所述的RF装置，其中：该冷却流体介质阀部件包括电磁阀。
62.根据权利要求50所述的RF装置，其中：该流体传送部件设置成传送足够量的冷却流体介质，以便可控制地使RF电极的后表面保持合适温度。
63.根据权利要求50所述的RF装置，其中：该流体传送部件设置成可控制地将足够量的冷却流体介质传送给RF电极的后表面，并保持RF电极的前表面的温度基本均匀。
64.根据权利要求49所述的RF装置，还包括：
热传感器，该热传感器与RF电极连接。
65.根据权利要求49所述的RF装置，还包括：
多个热传感器，这些热传感器与RF电极连接。
66.根据权利要求49所述的RF装置，还包括：
四个热传感器，这些热传感器与RF电极连接。
67.根据权利要求64所述的RF装置，其中：热传感器位于RF电极的后表面上。
68.根据权利要求64所述的RF装置，其中，热传感器与RF电极电绝缘。
69.根据权利要求64所述的RF装置，其中：热传感器从热电偶、热敏电阻、红外光电发射器和热敏二极管中选择。
70.根据权利要求49所述的RF装置，其中：该冷却流体介质阀部件的出口远离RF电极的后表面。
71.根据权利要求49所述的RF装置，其中：流体传送部件的几何形状和位置选择为使得流体在RF电极的后表面上基本均匀分布。
72.根据权利要求49所述的RF装置，其中：RF电极的厚度范围为0.010至1.0mm。
73.一种RF装置，包括：
装置组件，该装置组件包括壳体；
支承件，该支承件与壳体连接；
RF电极，该RF电极与支承件连接，该RF电极包括对着RF电极的后表面以及相反的前表面；以及
冷却流体介质分配组件，该冷却流体介质分配组件与该组件和支承件连接。
74.根据权利要求73所述的RF装置，其中：冷却流体介质分配组件包括流体传送部件，该流体传送部件与冷却流体介质阀部件连接。
75.根据权利要求74所述的RF装置，其中：该冷却流体介质阀部件位于装置组件内。
76.根据权利要求74所述的RF装置，其中：该冷却流体介质阀部件位于支承件内。
77.根据权利要求74所述的RF装置，其中：该流体传送部件位于装置组件内。
78.根据权利要求74所述的RF装置，其中：该流体传送部件位于支承件内。
79.根据权利要求74所述的RF装置，其中：该流体传送部件包括喷嘴。
80.根据权利要求74所述的RF装置，其中：该流体传送部件设置成向RF电极传送可控制量的冷却流体介质。
81.根据权利要求74所述的RF装置，其中：该流体传送部件设置成可控制地将冷却流体介质传送给RF电极的后表面。
82.根据权利要求74所述的RF装置，其中：流体传送部件设置成可控制地将流体传送给RF电极的后侧，以便蒸发冷却RF电极和传导性地冷却与RF电极的前侧接触的皮肤表面。
83.根据权利要求74所述的RF装置，其中：该流体传送部件设置成在RF电极的前表面相对于重力方向基本为任何方向的情况下，都可控制地将冷却流体介质传送给RF电极的后表面。
84.根据权利要求74所述的RF装置，其中：电极组件被密封成足以使从RF电极的后表面流向与RF电极的前表面接触的皮肤表面的冷却流体介质减至最少。
85.根据权利要求53所述的RF装置，其中：该电极组件包括通气孔。
86.根据权利要求74所述的RF装置，其中：该冷却流体介质阀部件设置成提供冷却流体介质的脉冲传送。
87.根据权利要求74所述的RF装置，其中：该冷却流体介质阀部件包括电磁阀。
88.根据权利要求73所述的RF装置，其中：RF电极的前表面设置成在RF电极的前表面相对于重力方向基本为任何方向的情况下都传导性地冷却与该RF电极的前表面接触的皮肤表面。
89.根据权利要求74所述的RF装置，其中：RF电极的前表面和冷却流体介质传送部件设置成在RF电极的前表面相对于重力方向基本为任何方向的情况下都传导性地冷却与该RF电极的前表面接触的皮肤表面。
90.根据权利要求73所述的RF装置，其中：RF电极包括导电部分和电介质。
91.根据权利要求73所述的RF装置，其中：RF电极包括导电部分以及电介质，该电介质布置成环绕导电部分的周边的至少一部分。
92.根据权利要求73所述的RF装置，其中：RF电极包括导电部分以及电介质，该电介质布置成环绕导电部分的整个周边。
93.根据权利要求73所述的RF装置，其中：支承件可拆卸地与装置组件连接。
94.根据权利要求93所述的RF装置，还包括：
永久性存储器，该永久性存储器与支承件连接。
95.根据权利要求94所述的RF装置，其中：该永久性存储器是EPROM。
96.根据权利要求73所述的RF装置，还包括：
永久性存储器，该永久性存储器与支承件连接。
97.根据权利要求96所述的RF装置，其中：该永久性存储器是EPROM。
98.根据权利要求73所述的RF装置，其中：RF装置壳体包括微处理器。
99.根据权利要求94所述的RF装置，其中：该永久性存储器提供了对传送给RF电极的电流的控制。
100.根据权利要求94所述的RF装置，其中：该永久性存储器提供了对冷却流体介质传送部件的工作循环的控制。
101.根据权利要求94所述的RF装置，其中：该永久性存储器提供了RF电极的能量传送持续时间的控制。
102.根据权利要求94所述的RF装置，其中：该永久性存储器相对于目标温度控制RF电极的前表面温度。
103.根据权利要求94所述的RF装置，其中：该永久性存储器提供了RF电极的最大发射次数。
104.根据权利要求94所述的RF装置，其中：该永久性存储器提供了可由RF电极传送的最大允许电压。
105.根据权利要求94所述的RF装置，其中：该永久性存储器提供了RF电极的使用历史。
106.根据权利要求94所述的RF装置，其中：该永久性存储器设置成使冷却流体介质传送部件进行可控制的工作循环，用于将冷却流体介质传送给RF电极的后表面。
107.根据权利要求94所述的RF装置，其中：该永久性存储器设置成使可控制传送量的冷却流体介质从冷却流体介质传送部件传送给RF电极的后表面。
108.根据权利要求74所述的RF装置，其中：该RF电极和流体传送部件设置成当RF电极的前表面施加在皮肤表面上时从RF电极的前表面上均匀地除去热量。
109.根据权利要求74所述的RF装置，其中：该RF电极和流体传送部件设置成从施加在皮肤表面上的RF电极前表面部分上均匀地除去热量。
110.根据权利要求74所述的RF装置，其中：该RF电极和流体传送部件设置成在RF电极的前表面相对于重力方向为任何方向的情况下都从施加在皮肤表面上的RF电极前表面部分上均匀地除去热量。
111.根据权利要求74所述的RF装置，其中：该RF电极和流体传送部件设置成传导性地冷却与RF电极前表面接触的皮肤表面。
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US9636175B2 (en) 2017-05-02
US20040111087A1 (en) 2004-06-10
AU2003207858A1 (en) 2003-09-02
US20140066918A1 (en) 2014-03-06
US20090287207A1 (en) 2009-11-19
AU2003207858A2 (en) 2003-09-02
EP1471845B1 (en) 2008-10-22
US20070010811A1 (en) 2007-01-11
US20190090947A1 (en) 2019-03-28
AU2003207858B2 (en) 2006-08-10
US7141049B2 (en) 2006-11-28
EP1471845A1 (en) 2004-11-03
US20170209212A1 (en) 2017-07-27
ES2314180T3 (es) 2009-03-16
EP1808145A2 (en) 2007-07-18
ATE411778T1 (de) 2008-11-15
US8603088B2 (en) 2013-12-10
JP2005516666A (ja) 2005-06-09
BR0307392A (pt) 2004-11-09
CA2474421A1 (en) 2003-08-14
DE60324249D1 (de) 2008-12-04
WO2003065916A1 (en) 2003-08-14

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