CN100425211C - 用于机头的rf电极组件 - Google Patents

用于机头的rf电极组件 Download PDF

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CN100425211C
CN100425211C CNB2004800112228A CN200480011222A CN100425211C CN 100425211 C CN100425211 C CN 100425211C CN B2004800112228 A CNB2004800112228 A CN B2004800112228A CN 200480011222 A CN200480011222 A CN 200480011222A CN 100425211 C CN100425211 C CN 100425211C
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electrode
supporting construction
skin
tissue
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CN1780588A (zh
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米奇·莱文森
布赖恩·韦伯
罗杰·A.·斯特恩
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Solta Medical Co
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Thermage Inc
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Abstract

一种RF装置，具有一个支撑结构。一个RF电极，与所述支撑结构相耦合，包括导电的和电介质部分。一个冷却元件，与所述支撑结构相耦合，其被配置为冷却RF电极的背表面。所述冷却元件离所述RF电极的背表面一定距离。

Description

用于机头的RF电极组件
技术领域
本发明主要涉及RF装置，并尤其涉及包含导电和电介质部分且与支撑结构相连的RF电极。
背景技术
人类皮肤有两种成分构成：表皮及其下层的真皮。带有皮肤角质层的表皮起到了对外部环境的生物屏障的作用。在表皮的底层，存在着能够形成色素的所谓黑素细胞。它们是皮肤颜色的主要决定因素。
下层的真皮为皮肤提供主要的结构支撑。它主要由被称为胶原质的胞外蛋白构成。胶原质由纤维原细胞产生，并与三种多肽链合成三链螺旋，所述的多肽链由热不稳定和热稳定的化学键连接在一起。当含有胶原质的组织被加热时，这种蛋白阵列的物理特性就会在特征温度下发生变化。胶原质收缩的结构性转换出现在特定的“收缩”温度下。胶原质阵列在加热情况下的收缩与重塑是本技术的基础。本技术也可以被用来对皮肤、皮肤附属物(汗腺、皮脂腺、毛囊等)或皮下组织结构产生其他影响。
胶原质交键可以是存在于分子内的(共价键或氢键)，也可以是分子间的(共价键或离子键)。分子内氢键的热分裂是由分裂活动与张弛活动(氢键重组)之间的平衡产生的纯量(scalar)过程。这种过程的发生无需借助外力。因而，分子间张力就由分子内氢键的热分裂产生。本质上，分子三级结构的收缩产生了最初的分子间收缩向量。
一个阵列中的胶原纤维表现出多种空间方向。如果所有向量的和起到了延长原纤维的作用，那么所述的阵列就会被延展。而如果所有外部向量的和起到了缩短原纤维的作用，那么就会促进所述的阵列收缩。分子内氢键的热分裂以及分子间交连键的机械断裂同样也受到张弛活动的影响，这种活动恢复原有的结构。然而，如果在胶原纤维的延长或收缩之后重新形成了交连键，那么分子长度就会永久性改变。持续施加外部机械力可以提高原纤维延长或收缩之后形成交连键的概率。
氢键断裂是一种量子力学事件，它需要一个能量阈值。所需的(分子内)氢键断裂总量对应于胶原纤维内离子键和分子间共价键两者的合成键强度。在达到这个阈值之前，胶原纤维的四元结构很少或是根本不会发生变化。而当分子间张力足够时，就会出现离子键和共价键的断裂。通常，离子键与共价键的分子间断裂的同时会出现棘轮效应，这是由于延长或收缩的原纤维中有极性和无极性区域的重新排列造成的。
胶原质交连键的断裂在较低温度下也会发生，但是发生的速度较慢。低级的热断裂往往与张弛现象有关，在这种现象中，交连键被重组但分子长度不会发生净变化。机械地分裂原纤维的外力会降低张弛现象的概率，并提供一种方法，可以在较低的温度下延长或压缩胶原质阵列，同时减少潜在的表面消融现象。
软组织重塑是一种生物物理学现象，它发生在细胞或分子级。胶原质的分子收缩或局部变性涉及能量源的运用，这会切断三链螺旋的热不稳定交连键，从而扰乱分子的纵轴。从而就产生了张力来打破阵列的分子间连键。这本质上是一种直接的细胞外过程，而细胞收缩需要一个滞后期来让伤口愈合过程所提供的纤维原细胞迁移并繁殖到伤口中。在高等的动物物种当中，对于伤害所产生的伤口愈合反应包括最初的发炎症状，这种症状接着会引起伤疤组织的沉积。
最初的发炎反应包括白血细胞或白血球的渗透，它们能够处理细胞残骸。七十二小时后，纤维原细胞在受伤部位大量繁殖。这些细胞分化为收缩性的成肌纤维细胞，而这些细胞则是细胞软组织收缩的来源。随着细胞的收缩，胶原质被累积在收紧的软组织结构中作为静态的支撑结构。这种初生伤疤结构的积累以及后续的重塑提供了一种手段来改变软组织的稠度和几何形状，以达到较好的美学效果。
通过上述的讨论可见，有多种皮肤学方法可以用于向皮肤及其下的组织传递热能以引起胶原质收缩，并/或引起伤口愈合反应。这些方法包括皮肤重塑/表面重修，去皱以及皮脂腺、毛囊脂组织和蛛网静脉的处理。
现有的向皮肤及其下组织传递热能的技术包括射频(RF)、光学(激光)和其他电磁波能量形式，以及超声和用热表面直接加热。但是，这些技术都有着技术上的限制和临床问题，它们限制了治疗的效果并/或完全排除了治疗方法。
所述的问题包括下列几种：i)在较大面积的组织上达到均匀的加热效果；ii)将加热效果所达到的深度控制在选定的目标组织上，并防止有害的热损伤达到目标及非目标组织；iii)减轻负面的组织效应，如烧伤、红肿起泡；iv)用更为连续的治疗实施(例如通过滑行或涂覆运动)替代拼接方式的能量/治疗实施；v)改善对皮肤表面难以到达区域的接触；vi)减少完成治疗所需的疗程时间以及病患访问的次数。在下文中将要说明，本发明提供了用以解决这些以及其他限制的装置。
用于治疗皮肤的现有RF技术的一个关键缺点是边缘效应现象。概括地说，当RF能量通过一个与组织接触的电极被施加或传递到那个组织时，电流集中在电极的边缘，特别是锐利的边缘上。这种效应通常被成为边缘效应。以圆盘形电极为例，所述的效应表现为圆盘周边较高的电流密度，以及中央相对较低的电流密度。对于方形电极而言，通常在整个周边都有较高的电流密度，而在转角处有更高的电流密度。
边缘效应造成皮肤治疗中的问题是有多种原因的。首先，它们导致电极表面上不均匀的热效应。在各种皮肤治疗中，在相对较大的表面区域上保持均匀的热效应是非常重要的，对于皮肤病治疗尤为如此，这种情况通常涉及若干平方毫米甚至若干平方厘米的面积量级。在用于切除组织的电外科学应用场合，通常有一个点型施用器，其设计目的在于产生一个热点，以切除甚至凝结组织。但是，这种点型设计对于在大表面面积上产生较为温和的热效应而言是不理想的。这里所需的是一种能够向皮肤及其下组织传递均匀热能而无热点的电极设计。
如果在皮肤/组织治疗程序中结合了加热与冷却，那么均匀的热效应就尤其重要。如下所述，非均匀的加热模式使得皮肤的冷却变得困难，从而导致治疗过程困难。当使用RF能量加热皮肤时，电极表面的组织趋于最暖，且温度随着深入组织而降低。克服这种热量梯度并在离开电极一定距离的位置产生热效应的一个方法是，冷却接触电极的皮肤层。但是，如果存在非均匀的加热模式，则皮肤的冷却就变得困难。
如果皮肤被充分冷却，从而在方形或矩形电极的转角处或是圆盘形电极的周边没有灼热现象，那么在中心部分就可能发生过分冷却，从而在电极的中心部分之下不会有任何明显的加热效应(即组织加热)。相反，如果将冷却效果降低到使得电极中心有良好的加热效果的程度，那么这种冷却就可能不足以保护与电极边缘接触的组织。由于以上的这些限制，在标准电极的典型应用场合中，皮肤表面上通常会有非均匀处理和/或灼伤的区域。因此加热模式的均匀性是非常重要的，特别是在处理皮肤的应用场合下，通常要对含有胶原质的皮层进行加热以产生胶原质收缩反应，以收紧皮肤。为了这种以及相关的应用，如果胶原质收缩以及相应的皮肤收紧效果是非均匀的，那么就会发生医学上的不良后果。
人们需要一种改进的RF装置，更需要一种适用于整形应用场合的RF装置，还需要一种采用改进的电介质RF电极的RF装置。
发明内容
因此，本发明的一个目标就是要提供一种改进的RF装置。
本发明的另一个目标是要提供一种RF装置，其中包括一个RF电极导电和电介质部分。
本发明的另一个目标是要提供一种与支撑元件相连的电介质RF电极。
本发明提供一种RF装置，包括：一个RF电极，其中包括导电与电介质部分，所述电介质部分接触皮肤表面，RF电极被设置为在所述RF电极的至少一部分与所述皮肤表面接触时被容性耦合到所述皮肤表面，所述的导电部分带有空隙，所述空隙中有很少或没有导电材料，以改变所述导电部分产生的电场。
本发明的这些及其他目标都被实现在一个带有支撑结构的RF装置中。一个与支撑结构相连的RF电极，其中包括导电和电介质部分。一个与支撑结构相连的冷却元件，被设置来冷却RF电极的背面。所述的冷却元件与RF电极的背面相隔一定距离。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与所述支撑结构相连的RF电极，包括导电和电介质部分，以及一个弯曲电路。一个与支撑结构相连的冷却元件，被设置来冷却RF电极的背面。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与所述支撑结构相连的RF电极，带有导电和电介质部分。第一与第二结合元件被形成在支撑结构的主体上。所述的第一与第二结合元件通过一个机头(handpiece)支撑结构提供装配与拆卸。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个包括导电与电介质部分的RF电极被设置为容性耦合，当该RF电极至少有一部分与皮肤表面接触时。一个背板被放置在靠近支撑结构的位置。有多个电接触垫片与背板相连。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个RF电极包括导电和电介质部分，一个组织接口表面以及一个相对的背表面。一个背板被设置在靠近支撑结构的位置。所述的背板包括一个前表面，它正对着RF电极的反向背表面，还包括一个反向的背表面。一个冷却元件带有一条沟道，沟道的末梢部分延伸过所述的背板，还带有一个近侧部分，它被提升到所述背板的背表面之上。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极，包括导电和电介质部分。所述的RF电极带有一个组织接口表面和一个反向的背表面。一个冷却元件与支撑结构相连。至少一个第一传感器与RF电极相连。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极，包括导电与电介质部分。RF电极带有一个组织接口表面和一个反向的背表面。一个冷却元件与支撑结构相连。一个非易失性存储器与支撑结构相连。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极，带有导电与电介质部分。一个与支撑结构相连的冷却元件被设置来冷却RF电极的背表面。冷却元件与RF电极的背面相距一段距离。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构，该支撑结构构成了RF装置的主体，其上有一个RF电极，该电极带有导电和电介质部分。RF电极包括一个弯曲电路。一个与支撑结构相连的冷却元件被设置来冷却RF电极的背面。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极，带有导电与电介质部分。第一与第二结合元件被形成在支撑结构的主体上。第一与第二结合元件通过一个机头支撑结构提供装配与拆卸。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极，带有导电与电介质部分。当该RF电极至少有一部分与皮肤表面接触时，它被设置为容性耦合。一个背板被放置在靠近支撑结构的位置。有多个电接触垫片与背板相连。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极包括导电和电介质部分，一个组织接口表面以及一个相对的背表面。一个背板被设置在靠近支撑结构的位置。所述的背板包括一个前表面，它正对着RF电极的反向背表面，还包括一个反向的背表面。一个冷却元件带有一条沟道，沟道的末梢部分延伸过所述的背板，还带有一个近侧部分，它被提升到所述背板的背表面之上。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极，包括导电和电介质部分。所述的RF电极带有一个组织接口表面和一个反向的背表面。一个冷却元件与支撑结构相连。至少一个第一传感器与RF电极相连。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极，包括导电与电介质部分。RF电极带有一个组织接口表面和一个反向的背表面。一个冷却元件与支撑结构相连。一个非易失性存储器与支撑结构相连。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极包括导电和电介质部分。RF电极带有一个组织接口表面、一个反向背表面和一个外边缘，所述外边缘的几何形状有助于减少外边缘上容性耦合面积的大小。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极包括导电和电介质部分。RF电极带有一个组织接口表面和一个反向背表面。RF电极的至少一部分上带有空隙，以减少RF电极中导电材料的数量。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极包括导电和电介质部分。RF电极被设置来在皮下组织上提供一个可控的组织效应，同时要保留皮下组织之上的表皮表面。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个RF电极与支撑结构相连。一个弯曲电路与RF电极相连。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构，一个RF电极和一个与RF电极相连的弯曲电路。多个电接触垫片与弯曲电路相连。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极包括导电和电介质部分。有多个电接触垫片与RF电极相连。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极包括导电和电介质部分。RF电极至少有一些部分具有不同的宽度。
在本发明的另一个实施例中，一个RF装置包括一个支撑结构。一个与支撑结构相连的RF电极包括导电和电介质部分。RF电极至少有一些部分具有不同的导电性。
在本发明的另一个实施例中，一个RF装置中包括一个带有导电和电介质部分的RF电极。一个支撑结构与RF电极相连。支撑结构与RF电极在支撑结构与RF电极相连处构成一个封口。
在本发明的另一个实施例中，一个RF装置中包括一个带有导电和电介质部分的RF电极。一个支撑结构与RF电极相连。一个与支撑结构相连的冷却元件被设置来为RF电极的背表面制冷。所述的冷却元件与RF电极的背表面相距一定的距离。支撑结构和RF电极在两者相连处构成一个封口。
附图说明
图1(a)示出了本发明的机头的一个实施例的截面视图；
图1(b)示出了带有热电制冷器的RF装置的一个实施例的截面视图；
图2示出了图1所示RF电极组件的分解视图；
图3(a)示出了本发明的RF电极的一个实施例的特写视图；
图3(b)示出了一个可用于本发明的RF电极实施例，该电极的外部边缘的几何形状被设置来减少外边缘容性耦合的面积大小。
图3(c)示出了一个可用于本发明的RF电极实施例，该电极带有一些含有很少导电材料的空隙。
图4示出了图1所示RF电极组件的截面视图。
图5示出了本发明所述RF机头组件的一个实施例的侧视图。
图6示出了图5所示RF电极组件的后视图。
具体实施方式
在各个实施例中，本发明提供了用于治疗组织位置的方法。在一个实施例中，一个能量传递装置的能量传递表面与皮肤表面相联系。这种联系可以是直接将能量传递装置的能量传递表面放置在皮肤表面产生接触，或是在两者之间设置一定距离并借助或不借助一种介质来从能量传递装置的能量传递表面向皮肤表面传导能量。皮肤表面被充分冷却以产生一个相反的热梯度，其中皮肤表面的温度要低于其下的组织。能量从能量传递装置被传递到其下的组织区域，并在皮肤表面产生组织效应。
下面参见图1(a)，本发明所述方法可以借助机头10来实现。机头10与机头组件12相连，后者包括一个机头外壳14和一个冷却液体介质阀门元件16。机头外壳14与电极组件18相连。电极组件18具有至少一个RF电极20，当RF电极20的至少一部分与皮肤表面产生接触时，该电极与皮肤表面容性相连。在不限制本发明范围的前提下，假设RF电极20可以具有0.010至1.0毫米的厚度。
机头10向选定深度的组织提供更为均匀的热效应，同时防止或最小化对皮肤表面及其他非目标组织造成的热损伤。机头10与一个RF发生器相连。RF电极20可以以单极或双极模式工作。机头10被设置来减少或消除边缘效应与热点。结果就是可以得到改善的美学效果/临床疗效，而消除/减少副作用与治愈时间。
一个液体输送元件22与冷却液介质阀门元件16相连。液体输送元件22和冷却液介质阀门元件16共同构成一个冷却液介质分发组件。液体输送元件22被设置来向RF电极20提供冷却液介质的雾化输送。雾化输送是一种薄雾或精细的喷雾。冷却液介质在触及RF电极20的表面时发生从液态到气态的相变。从液态到气态的相变产生冷却效果。如果冷却液介质在触及RF电极20之前发生相变，那么对RF电极20的冷却就不那么有效了。
在另一个实施例中，如图1(b)所示，一个热电制冷器23被用来取代冷却液介质阀门元件16和液体输送元件22。
在一个实施例中，冷却液介质是低温喷雾，可从新泽西州Morristown的Honeywell公司购得。一种适用的低温喷雾是R134A2，可从位于纽约长岛市(11101)33街38-18的Refron公司购得。使用低温冷却液介质使得使用多种不同类型算法进行皮肤治疗成为可能。例如，低温冷却液介质可以在向目标组织传递RF能量之前和之后数毫秒间施用。这一点可以通过使用与制冷剂源相连的冷却液介质阀门元件16来实现，其中包括但不局限于压缩气灌。在各种实施例中，冷却液介质阀门元件16可以与计算机控制系统相连，并且/或者可以由医师通过脚踏开关或类似装置人工控制。
提供低温冷却液介质的喷雾、雾化特别有用，因为这样能够提供实现快速开关控制的可能性。低温冷却液介质允许对冷却过程进行更精确的温度控制。这是因为冷却只在冷却剂被喷覆或处于蒸发状态时才会发生，后者是快速而短暂的事件。因此，在低温冷却液介质停止后，冷却也会迅速停止。最终的效果是实现对低温冷却液介质的精确开关时间控制。
下面参见图2，液体输送元件22和热电制冷器23可以被设置在机头外壳14或电极组件18中。液体输送元件22被设置来可控地输送冷却液介质。液体输送元件22和热电制冷器23冷却RF电极20的背表面24，并将背表面24保持在理想的温度下。冷却液介质挥发性地冷却RF电极20并为RF电极20的前表面26保持大致均匀的温度。液体输送元件22挥发性地冷却背表面24。前表面26可以是也可以不是有弹性和与皮肤一致的，但它仍应具有能够在被压迫在皮肤表面时提供优良热接触的足够力量和/或结构。
RF电极20接着通过传导方式冷却靠近RF电极20的前表面26的皮肤表面。适用的液体介质包括多种冷却剂，如R134A和氟利昂。
液体输送元件22被设置来可控地在前表面26上相对重力方向的任意方向将冷却液介质输送到背表面24。液体输送元件22的几何形状和定位经过适当的选择，以便在背表面24上提供大致均匀的冷却液介质分布。冷却液介质的输送可以通过让液滴喷雾或精细薄雾浸没背表面24或类似方式来实现。冷却发生在冷却液介质与大气接触的界面上，即蒸发发生处。如果在背表面24上有较厚的液体层，那么从经过处理的皮肤上去除的热量就必须通过所述较厚的冷却液介质层，从而提高了热阻率。为了使冷却速度最大化，最好施用一层很薄的冷却液介质。如果RF电极20不是水平的且存在一层较厚的冷却液介质，或者如果在背表面24上有大滴的冷却液介质，那么冷却液介质就可能流下RF电极20的表面并聚集在一个边缘或角落，从而造成不均匀冷却。因此，最好通过精细喷雾施加一层很薄的冷却液介质。热电制冷器23能达到相同的效果，但却不需要输送冷却液介质。热电制冷器23在靠近或接触表面24的一侧是冷的，而相反的一侧则变得较暖。
在各种实施例中，RF电极20如图3(a)所示，都带有一个导电部分28和一个电介质部分30。导电部分28可以是金属的，包括但不局限于铜、金、银、铝等等。电介质部分30可以由各种不同的材料制成，包括但不局限于聚酰亚胺、特富龙及类似材料、氮化硅、聚硅烷、聚酰亚胺、Kapton及其他聚合物、天线电介质以及其他现有的电介质材料。其他电介质材料包括但不局限于聚合物如聚酯、硅、蓝宝石、钻石、锆硬化矾土(ZTA)、矾土等等。电介质部分30可以设置在至少一部分导电28周围，或是在整个导电部分的周围。在另一种实施例中，RF电极20由合成材料制成，包括但不局限于镀金铜、聚酰亚胺铜、硅/氮化硅等等。
电介质部分30对流经RF电极20的电流产生较高的阻抗。这种提高的阻抗使得电流直接经过导电部分28抵达皮肤表面。流出RF电极20边缘的电流集中所造成的电场边缘效应也得以减轻。
电介质部分30在整个RF电极20中产生更为均匀的阻抗，并使得流经导电部分28的电流更加均匀。最终的效果是减轻甚至消除了RF电极20边缘周围的边缘效应。如图3(c)所示，RF电极20可以带有空隙33，其中很少甚至没有导电材料。在导电材料中造成空隙33会改变电场。空隙的特定设置可被用来减轻边缘效应，或是改变电场深度、均匀性或是形状。在RF电极20的一个带有实心导电材料的部分28’之下，电场较深。而在RF电极20中带有多个空隙的部分28”之下，电场就较浅。通过组合不同浓度的导电材料，就能制成可以匹配所需加热效果的RF电极20。
在一个实施例中，导电部分28粘附于电介质部分30，后者可以是具有一定厚度的衬底，举例来说，其厚度可以是0.001”。该实施例与电子工业中商用的标准弯曲(flex)电路板材料类似。在该实施例中，电介质部分30与组织、皮肤接触，而导电部分28则与皮肤分离。
通过利用各种技术在电介质部分30上生长导电部分28，可以减小电介质部分30的厚度，所述的方法包括但不局限于阴极溅镀、电镀、化学蒸镀、等离子沉积以及其他现有的沉积技术。另外，同样的过程也可以被用来将电介质部分30镀到导电部分28上。在一个实施例中，电介质部分30是一个可以在导电部分28上生长的氧化层。氧化层具有低热阻，且与许多其他电介质如聚合物相比，能改善皮肤的冷却效率。
在各种实施例中，RF电极20被设置来限制沿其外侧边缘31容性耦合到组织。参见图3(b)，RF电极20外测边缘31的几何尺寸可以被设置来减少外测边缘31的容性耦合面积。外测边缘31可以含有较少的导电材料部分28。这可以通过不同的几何形状来实现，包括但不局限于扇形几何形状等等。外侧边缘31的总长度可以随不同几何形状增加，而与组织容性耦合的总面积应该减少。这样就减少了外测边缘31周围的能量生成。
或者，也可以在边缘处施用较厚的电介质材料层，从而降低边缘处的电场。另一种方案是设置冷却机制在边缘处进行更强劲的冷却，以补偿任何电场边缘效应。
液体输送元件22带有引入口32和引出口34。引出口34的横截面积可以小于引入口32的横截面积。在一个实施例中，液体输送元件22是一个喷嘴36。
冷却液介质阀门元件16可以被设置来提供冷却液介质的脉冲输送。脉冲式输送冷却液介质是一种控制冷却液介质施用速率的简单途径。在一个实施例中，冷却液介质阀门元件16是一个螺形管阀门。一个适用的螺形管阀门实例是由NJ West Caldwell的N-Research公司制造的螺形管拧阀门。如果液体受压，则阀门开启使液体流动。如果将液体保持在恒定的压力，则流动速率恒定，且可以使用简单的开关螺形管阀门，有效流动速率由脉冲占空周期决定。较高的接近100％的占空周期能增强冷却，而较低的接近0％的占空周期则减弱冷却。占空周期可以通过以固定频率打开阀门一段较短的时间来实现。打开时间的长度可以在1至50毫秒之间或更长。脉冲频率可是在1至50赫兹或更快。
另外，冷却液介质流动速率也可以通过配量阀或可控速率泵(如蠕动泵)来控制。脉冲的一个优点在于它可以通过简单的电子装置与控制算法来控制。
电极组件18应该密封完好，从而冷却液介质不会从背表面24泄漏到与RF电极20接触的皮肤表面上。这样有助于在皮肤表面产生均匀的能量输送。在一个实施例中，电极组件18、更具体的说是RF电极20的几何形状能够在背表面24上产生一个储蓄池，以容纳和收集聚集在背表面24上的冷却液介质。背表面24的形状可以仿照“医院床单折角铺叠法(hospital corners)”，以产生所述的储蓄池。或者，电极组件18包括排泄孔，允许蒸汽化的冷却液介质从电极组件18溢出。
排泄孔防止在电极组件18中累积压力。排泄孔可以是一个通往大气或排泄管线的压力释放阀。当冷却液介质与RF电极20产生接触并蒸发时，产生的气体就会挤压电极组件18的内侧。这会引起RF电极20部分膨胀，并从前表面26向外弯曲。膨胀的RF电极20有助于与皮肤的热接触，从而使RF电极20对皮肤表面产生一定的顺应性。可以使用一个电子控制器，当达到预定压力时，该电子控制器发送一个信号来打开排泄孔。
多条导线40与RF电极20相连。一个或多个热传感器42与RF电极相连。适用的热传感器42包括但不局限于热电偶、电热调节器、红外光电发射器以及热感应二极管。在一个实施例中，RF电极20的各个角上都装有一个热传感器42。其中提供了足够数量的热传感器42，以获取足够多的关于皮肤表面或电极20背面24的热数据。热传感器42与RF电极20之间电绝缘。在另一个实施例中，在RF电极背面24上至少设置一个传感器42，并响应于冷却液介质的输送检测背表面24的温度。
热传感器42测量温度并提供反馈，以便在治疗期间监测RF电极20和/或组织的温度。热传感器42可以是电热调节器、热电偶、热感应二极管、电容、电感或其他用于测量温度的装置。热传感器42最好能向与RF电极20相连的RF发生器上的微处理器提供电子反馈，以辅助控制治疗过程。
来自热传感器42的测量值可以被用来帮助控制冷却液介质的施用速率。例如，可以采用一个冷却控制算法，以高速率向RF电极20施用冷却液介质，直到温度降至目标温度以下位置，然后就减慢速度或停止。可以采用PID或是比例积分微分算法将RF电极20温度精确控制在预定值。
热传感器42可以设置在远离组织的RF电极20背表面24上。该结构对于控制RF电极20的温度是比较理想的。或者，热传感器42也可以被设置在RF电极10与组织直接接触的前表面26上。该实施例对于监测组织温度更为适用。通过使用热传感器42及相关算法来计算被处理组织的温度资料。热传感器42可以被用来产生皮肤的温度资料，该资料可被用于疗程控制来保证输送适量的加热与冷却，以实现得到提升的深层组织温度，同时将皮肤组织层保持在阈值温度以下，以防止热损伤。
外科医生可以使用测得的温度资料来保证他保持在对于某类治疗而言理想/平均水平的界限之内。热传感器42可以被用于额外的目的。当热传感器42的温度被监测时，就可以检测到RF电极20何时与皮肤表面接触。这可以通过检测发生皮肤接触时的直接温度变化，或是检查受皮肤接触影响的温度变化率来实现。同样，如果有多个热传感器42，那么就可以使用热传感器42来检测RF电极20的一部分是否被抬离皮肤或失去与皮肤的接触。这一点很重要，因为传递到皮肤的电流密度(每单位面积上的安培数)可能随接触面积变化而改变。特别是，如果RF电极20的部分表面未与皮肤接触，那么产生的电流密度就要高于预期值。
再参见图1(a)，一个力传感器44也与电极组件18相连。力传感器44检测由电极组件18通过外科医生向皮肤表面所施加的力。力传感器44减去电极组件18的重量在RF电极20的前表面26相对于重力方向的任意方向上的重力效应。另外，力传感器44还在RF电极与皮肤表面产生接触时给出指示。力传感器44还提供一个信号来指示RF电极20向接触皮肤表面所施加的力是(i)超过最小阈值，或是(ii)低于最大阈值。
如图4所示，一个启动按钮46与力传感器一同被使用。在启动RF电极20之前，外科医生将机头10保持在皮肤表面附近。机头10的方向可以是相对于重力方向的任何角度。要使用机头10的时候，外科医生可以按下启动按钮46，该按钮通过将力传感器44读数置零来均衡它。这样就去除了由于特定治疗方向上的重力所引起的力。该方法使得不论机头10相对重力方向呈何角度，由RF电极20向皮肤表面施加均匀的力。
RF电极20可以是一个弯曲电路，该电路包括追踪元件。另外，热传感器42和力传感器44也可以构成弯曲电路的一部分。另外，弯曲电路还可以包括电介质部分，它构成了RF电极20的一部分。
电极组件18可以活动地安装在机头外壳12内。在一个实施例中，电极组件18可以沿机头外壳12的纵向轴滑动。
电极组件18可以被可旋转地安装在机头外壳12上。另外，RF电极20可以被可旋转地安放在电极组件18上。电极组件18可以被活动地连接到机头外壳12，作为可拆卸或不可拆卸的RF装置52。
为了本发明公开的目的，电极组件18与RF装置52相同。一但被活动地安装到机头外壳12上，RF装置52可以通过力传感器44与机头外壳12相连。力传感器44可以是能测量压力和拉力的类型。在其他实施例中，力传感器44只测量压力，或只测量拉力。
RF装置52可以用弹簧48做弹簧负载。在一个实施例中，弹簧48将RF电极20拉向机头外壳12的方向。这样就能对力传感器44产生一个预负载，并保持RF装置52被压在力传感器44上。在RF电极20被施加到皮肤表面之前按下启动按钮46时，该预负载力才被均衡。
一个护罩50可选地与机头10相连。护罩50防止用户在RF装置52工作期间触及RF装置，这有可能引起错误的力读数。
一个非易失性存储器54可以被包含在RF装置52中。另外，非易失性存储器也可以包括在机头外壳12中。非易失性存储器54可以是EPROM等。另外，一个第二非易失性存储器可以被包括在机头外壳12内，用于存储机头10的信息，包括但不局限于机头型号或版本、机头软件版本、机头10自带的RF应用程序编号、过期日期及制造日期。机头外壳12还可以包括一个微处理器58，用于从位于机头外壳12或RF装置52的各个传感器获取并分析数据，其中包括但不局限于热传感器42、力传感器44、流体压力量具、开关、按钮等等。
微处理器58还可以控制机头10上的元件，其中包括但不局限于灯、LED、阀门、泵或其他电子元件。微处理器58还可以与RF发生器的微处理器交换数据。
非易失性存储器54可以存储多种数据，这些数据有助于对机头10及其相关系统的控制与操作，其中包括但不局限于，(i)控制RF电极20所输送的电流量，(ii)控制液体输送元件22和热电制冷器23的占空周期，(iii)控制RF电极20的能量输送持续时间，(iv)控制RF电极20相对于目标温度的温度，(v)提供RF电极20的最大发射次数，(vi)提供RF电极20所能输送的最大电压，(vii)提供RF电极20的使用历史，(viii)提供液体输送元件22和热电制冷器23向RF电极20背表面输送冷却液介质的可控占空周期，(ix)提供从液体输送元件22向背表面24输送冷却液介质的可控输送速率，(x)提供对热电制冷器23等元件的控制。
下面参见图5和图6，RF装置52包括一个支撑结构，包括但不局限于外壳60，它决定了RF装置52的主体。RF装置52可以包括一个背板62，它位于靠近支撑结构60的位置。多个电接触垫片64可被设置在背板62上。液体输送元件22和热电制冷器23的至少一部分可以延伸通过背板62。液体输送元件22可以是一条带有一个近端点的沟道，所述的近端点被提升到背板62的背表面之上。
在支撑结构60的主体内还可以形成第一与第二固定元件64。固定元件64提供与机头外壳14的装配与拆卸。适用的固定元件64包括但不局限于揿钮、与基板支撑60上的揿钮元件相接的孔洞，等等。
机头10可被用来输送用于处理组织的热能，所述的组织包括但不局限于，表皮中含有胶原质的组织、真皮与皮下组织层，包括脂肪组织。对于组织的处理包括改变组织的物理特性、组织的机构或是组织的物理属性。所述的处理可以通过传递足够热量，以改变含胶原质组织、引起胶原质收缩以及/或包括初生胶原质在内的伤口愈合反应等等来实现。
机头10可以被用来进行对皮肤及其下组织的多种治疗，包括但不局限于，(i)皮肤重塑与拉紧，(ii)除皱，(iii)减少弹性组织变性，(iv)去疤，(v)皮脂腺切除/消除与皮脂腺活性降低，(vi)毛囊去除，(vii)脂肪组织重塑/消除，(viii)蛛网血管消除，(ix)修改皮肤表面的轮廓不规则性，(x)产生伤疤或初生胶原质，(xi)降低皮肤的细菌活性，(xii)减小毛孔大小，(xiii)清通毛孔等等。在各种实施例中，可将机头10用于多种治疗程序，包括但不局限于，(i)在向组织输送能量前的预冷却，(ii)与冷却相关联的开启过程或能量输送过程，(iii)在结束向组织输送能量之后的后冷却。
机头10可被用来预冷却目标组织的表面层，从而当RF电极20与组织产生接触时，或是在打开RF能量源之前，目标组织的表面层已经被冷却。当RF能量源被打开，或是开始向组织输送RF从而导致组织发热时，已经被冷却的组织就得到保护，不受热效应包括热损伤的影响。未被冷却的组织将升温至治疗温度，而达到所需的疗效。
预冷却为冷却的热效应向下传递到组织内提供了时间。更具体的说，预冷却使得可以实现理想的组织深度热度分布，且在选定深度上得到最低的理想温度。预冷却的持续时间可以被用来选择不需处理的组织保护区域的深度。较长的预冷却时间产生较深的保护区域，从而也产生较深的组织处理区域起始位置。对于较短的预冷却时间来说情况刚好相反。RF电极20的前表面26的温度也会影响温度分布。前表面26的温度越低，冷却就越快越深，反之亦然。
后冷却是非常重要的，因为它防止并/或减少了深层的热量向上传导并将较浅的层次加热到治疗或损伤温度范围内，尽管外部向组织的能量传递已经停止了。为了防止这种情况以及相关的热现象，最好在停止施用RF能量一段时间之后保持冷却治疗表面一段时间。在各种实施例中，可以结合实时冷却和/或预冷却采用变化的后冷却量。
在各个实施例中，机头10可被用于不同数量的脉冲开关型冷却程序，且可使用算法。在一个实施例中，治疗算法通过开始喷射低温冷却液介质来提供组织预冷却，随后再向组织内发射RF能量短脉冲。在该实施例中，在输送RF能量同时仍然继续进行低温冷却液介质的喷射，并在毫秒级的时间后停止。此处所举的或是其他治疗程序都可以被重复。因此在各种的实施例中，治疗程序可以包括以下的脉冲式顺序步骤，启动冷却、加热、停止冷却、启动冷却、加热、停止冷却，其中冷却和加热的持续时间在数十毫秒的量级。在这些实施例中，每次皮肤组织的表面被冷却时，热量都被从皮肤表面去除。低温冷却液介质喷射的持续时间以及喷射之间的间隔可以在数十毫秒的范围内，这样就使得表面冷却的同时仍然向更深层的目标组织传递热效应。
在各个实施例中，待治疗的目标组织区域，也被称为治疗区域或热效应区域，大约在皮肤表面下100微米至10毫米深度的范围内，具体深度取决于治疗的类型。对于涉及胶原质收缩的治疗而言，最好同时冷却表皮以及位于表皮下的真皮表面层，达到冷却深度范围在100微米至2毫米之间。不同的治疗算法可以包括不同数量的预冷却、加热及后冷却阶段，以便在所需的深度产生理想的组织效应。
根据治疗的类型，可以采用各种不同占空周期、开关时间的冷却和加热。所述的冷却和加热占空周期可以由现有的电子控制系统控制或动态改变。特别的，控制系统可以被用来控制冷却液介质阀门元件16以及RF电源。
以上对本发明优选实施例的说明起到了示例与描述的作用。本文并非旨在穷举所有情况并将本发明限制在公开的形式中。很明显，对于精通本技术的实践者而言，很容易作出许多修改与变型。本发明的范围由以下的权利要求及同等条款限定。

Claims (5)

1. 一种RF装置，包括：
一个RF电极，其中包括导电与电介质部分，所述电介质部分接触皮肤表面，RF电极被设置为在所述RF电极的至少一部分与所述皮肤表面接触时被容性耦合到所述皮肤表面，所述的导电部分带有空隙，所述空隙中有很少或没有导电材料，以改变所述电极产生的电场。
2. 根据权利要求1所述的装置，其中所述的空隙被设置来减轻RF电极边缘处的边缘效应。
3. 根据权利要求1所述的装置，其中所述的空隙被设置来影响RF电极所产生的电场的深度、均匀性以及形状中的至少一项。
4. 根据权利要求1所述的装置，还包括：
至少一个与RF电极相连的第一传感器。
5. 根据权利要求1所述的装置，还包括：
一个支撑结构；
所述RF电极被耦合到所述支撑结构；以及
形成在所述支撑结构主体中的第一与第二固定元件，所述的第一与第二固定元件提供与一个机头支撑结构的接合与分离。
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US20030216728A1 (en) 2003-11-20
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WO2004087253A3 (en) 2004-12-29
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CN1780588A (zh) 2006-05-31
CA2519304A1 (en) 2004-10-14
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