CN102599974A - 用于部分皮肤处置的方法和装置 - Google Patents

用于部分皮肤处置的方法和装置 Download PDF

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CN102599974A
CN102599974A CN2012100964385A CN201210096438A CN102599974A CN 102599974 A CN102599974 A CN 102599974A CN 2012100964385 A CN2012100964385 A CN 2012100964385A CN 201210096438 A CN201210096438 A CN 201210096438A CN 102599974 A CN102599974 A CN 102599974A
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Y·O·阿达尼
G·纳赫肖恩
B·莱维纳
A·罗森贝格
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Abstract

用于美容RF皮肤处置的装置，其中，RF能量供应与所处置的患者隔离，从而在处置的过程中，不期望的电流不流经受试者身体。

Description

用于部分皮肤处置的方法和装置
本申请是2010年7月12日提交的申请号为201080032750.7、名称为“用于部分皮肤处置的方法和装置”的分案申请。
技术领域
本方法和装置通常涉及皮肤处置程序，特别涉及美容皮肤表面重修和复原程序。
背景技术
部分皮肤表面重修或复原是近来开发的皮肤消融技术。存在着用于消融皮肤的两种类型的设备：基于激光的设备和基于RF的设备。这两种类型的设备都消融具有极小直径的浅孔或浅区的图案。孔是被未处置的皮肤区域包围的在显微镜下的小处置区。处置导致非常迅速的愈合或恢复以及所处置的皮肤的表面重修。在处置区的愈合过程中，出现新的皮肤层，恢复新鲜、年轻的肤色。
小孔的图案典型地由X-Y扫描激光束或通过RF能量或电压的施加而产生。激光聚焦于皮肤上，并且，通常以脉冲模式工作，从而消融皮肤中的微米尺寸的孔。
基于RF的部分皮肤处置产生与激光相似的皮肤中的微米尺寸的孔的扫描图案。典型地，能量由施加器递送至皮肤，该施加器由布置成矩阵或阵列的多个电压至皮肤施加/递送元件或接触元件的顶端装备。电压至皮肤施加元件放置为与将被处置的皮肤段接触，并且，由合适的功率和频率的RF能量源驱动。向电极施加高压RF脉冲将相应电极下面的皮肤消融形成小孔。
在某些实例中，尽管基于个体的经验可能因受试者而异，这样，痛觉可能因受试者而异，激光或RF电压脉冲的施加还是对所处置的受试者引起不适且甚至疼痛。在其他实例中，在相同的处置会话由施加器形成的微米的孔的大小可能存在着差异。较大尺寸的孔的愈合可能花费比较小尺寸的孔的愈合过程更长的一段时间，并且，在某些实例中，较大的孔可能倾向于导致引起对皮肤的损伤，而不是产生期望的皮肤效果。
为了缓和不适并减少疼痛以及与部分处置相关联的其他副作用，实践者开始使用外敷的利多卡因乳膏或甚至口服镇静剂。
部分皮肤处置可应用于诸如老化痕迹、皱纹、变色、痤疮瘢痕、纹身去除以及其他皮肤缺陷的几乎所有美容皮肤缺陷的校正中。基于RF的产品的成本低于利用激光辐射来操作的产品，并且，如果能够消除与其使用相关联的不适和偶尔疼痛，则基于RF的产品很可能广泛使用。
相同受让人的美国专利申请公布No.2006/0047281和美国专利申请公布No.2009/0299361公开基于RF的产品，例如适合于部分皮肤处置的eMatrixTM。
发明内容
词汇
在本公开的背景下，“RF电压”和“RF能量”可交换地使用并具有相同的意思。这两个参数之间的数学关系是众所周知的，并且，参数之一的知识允许容易地确定另一个。
在本公开的背景下，“皮肤电阻”和“皮肤阻抗”可交换地使用并具有相同的意思。这两个参数之间的数学关系是众所周知的，并且，参数之一的知识允许容易地确定另一个。
如在本公开中使用的术语“期望的皮肤效果”意指RF能量施加的结果，该结果可以是除皱、脱毛、胶原收缩或破坏、皮肤复原以及其他美容和皮肤处置。
术语函数的“稳定水平”是函数具有恒定值的域的一部分。
简要总结
一种用于美容RF皮肤处置的装置，其中，RF能量供应与所处置的受试者隔离，从而在处置的过程中，不期望的电流不流经受试者身体。装置包括施加器，施加器具有顶端，该顶端由多个电压施加的圆顶形状的元件和电极的集群填充，该电压施加的圆顶形状的元件从顶端表面突起并组织成一个共同的集群，该电极的集群约束圆顶形状元件，并且，具有大于圆顶形状元件的面积。装置将具有足以引起期望的皮肤效果的大小的电压施加至元件。限流器限制RF感应电流，从而防止皮肤损伤。装置连续地感测所处置的皮肤段的阻抗，并且，在低的皮肤阻抗时改变RF能量以及/或者在太低或太高的皮肤阻抗的情况下停止脉冲。
附图说明
统称为图1的图1A和图1B是用于部分皮肤处置的现有技术的RF施加器顶端的示意性图解说明；
图2是用于驱动用于部分皮肤处置的RF施加器顶端的现有技术的RF电压供应电路的示意性图解说明；
图3A至图3C是用于部分皮肤处置的顶端的等效电路的示意性图解说明；
图4是用于部分皮肤处置驱动电路的本顶端的示范性实施例的示意性图解说明；
图5是用于部分皮肤处置驱动电路的本顶端的另一示范性实施例的示意性图解说明；
图6是RF能量脉冲的施加下的皮肤电阻变化的示意性图解说明；
图7是用于部分皮肤处置控制电路的本顶端的示范性实施例的示意性图解说明；
图8是用于部分皮肤处置的本RF施加器顶端的示范性实施例的示意性图解说明。
具体实施方式
参考附图和在图中显示的非限制性的、示范性的实施例的附随的描述，可以更好地理解方法和装置的原理和实行。
对图1进行参考，图1是相同受让人的美国专利申请公布No.2009/0299361中公开的用于部分皮肤处置的现有技术的RF施加器顶端的示意性图解说明。载体100可以是具有0.5密耳至6密耳(12.5微米至150微米)的示范性厚度范围的由聚酰亚胺薄膜或类似的材料制成的柔性或刚性的物品，在该载体100上形成电压至皮肤递送元件或接触元件。本公开的背景下的术语“载体”意指具有电压至皮肤施加元件的阵列、电压至皮肤施加元件的二维阵列或矩阵的基体。基体104在其表面112之一上具有微型(微观)离散电压至皮肤施加元件116的阵列或矩阵，该元件从表面112突起并以圆顶型形状120终止。布置在基体104的背侧或第二侧上的以折线显示的导体124和128的图案实现对所有元件116、一个集群的元件116或单独地对每个元件116进行寻址。在其上形成有电压至皮肤递送元件的载体100配置为允许快速附接至施加器，并且，在本文献中被叫作“顶端”或“施加器顶端”。通过在载体104的背侧上形成与在基体104中相应的接触布置连通的接触点或接触带108，从而提供实现连接至射频电压源的RF接触的布置。电压至皮肤递送元件116以对称图案布置，所有偶数排124连接至RF供应接触带或端口124中的一个，而所有奇数排128连接至另一个或第二接触带或RF供应端口128。
图2是用于驱动RF施加器顶端以进行部分皮肤处置的现有技术的RF电压供应电路的示意性图解说明。RF电压源200可以位于独立壳体204中。可替代地，RF电压源可以位于以折线显示的施加器外壳208中。该源通过屏蔽线束220而将RF电压提供至施加器顶端212，特别是提供至电压至皮肤递送元件216。屏蔽体224以折线和点线示意性地显示。线束220的长度被选择为实现方便的照顾者操作，并且，可以是例如一至两米长。在屏蔽体224以及RF电流导线240和244的每个之间存在有某个寄生电容232和236。所处置的受试者还具有某个电容248。对于皮肤处置，顶端212放置为与将被处置的皮肤段228接触。作为被组织成偶数排124和奇数排128或集群的电压至皮肤递送元件216与将被处置的该皮肤段228的不均匀接触的结果，可能形成不期望的RF电流路径252。该电流通过受试者228，并且，可能引起痛觉，甚至引起对受试者的电击。
图3是与所处置的该皮肤段接触的用于部分皮肤处置的顶端212的等效电路的示意性图解说明。图3A示意性地显示顶端212，位于顶端212的奇数排1、3、5和7中的所有接触元件330共同地标记为302并显示为连接至RF电压源306的第一RF端口，并且，位于偶数排2、4、6和8中的所有接触元件共同地标记为310并显示为连接至RF电压源306的第二RF端口。所有接触元件都与例如具有相对较低的电导率的角质层的上皮肤层320接触，其中，数字324标记真皮层以及与角质层相比而具有相对较高的电导率的甚至更深的皮肤层。
参考图3B，从每个接触元件通过低电导皮肤层的电通道表示为电阻器(为了解释的简单，忽略通道电容)。高电导率真皮表示为普通电阻器Rs。在图3C中显示进一步的等效电方案简化，其中，所有奇数电阻器已被等效电阻器Ru取代而偶数排电阻器由Re取代。典型地，单个接触元件电阻器中的每个是50K-100K欧姆，因此，Ru和Re各自是大约2K欧姆，然而，Rs是较小的大约200欧姆的数量级，并且，出于讨论的目的而忽略。
由于不是所有电压至皮肤递送元件或接触元件330(图3A)都可以适当地附接至皮肤，并且，某些元件可能承受来自先前的处置的一些污垢和其他残渣，并且，不同的皮肤段可能具有不同的电阻，因此对通过每个接触元件并相应地通过接触元件形成的集群(偶数或奇数集群)的电流的电阻存在着差异。如果RF电压或能量流入Ru或Re电阻器中的任何一个，则增加其电阻，生成正反馈，在该正反馈下，较大的电阻器得到比较小的电阻器更多的能量，其电阻更迅速地增加，因此，得到甚至更多能量等。最终结果是，Ru或Re集群中最初具有较大的值一个最后获取大部分能量并在皮肤上留下不同的痕迹(例如，仅位于偶数或奇数排中的接触元件可以留下痕迹)。这降低处置的疗效并生成不期望的皮肤效果、过度疼痛以及甚至电击。
为了解决该问题，如在转让至相同受让人的美国专利申请序号12/324,932中所公开的，有可能单独地对每个接触元件或管脚(pin)进行寻址，并且，将每个接触元件或管脚通过大阻抗而连接至电压源，该大阻抗能够是电阻器、小电容、大电感器或所有这些的组合。这使至每个个体通道的RF感应电流稳定，从而降低接触元件和接触元件的集群之间的“竞争”。出于灭菌和卫生的目的，一次性顶端的使用优选为可再用顶端的使用。然而，对每个个体接触元件的寻址使这样的顶端复杂化并增加制造这样的顶端的成本。
使每个接触元件的电阻或阻抗相等并降低痛觉和至所处置的受试者的潜在电击的另一个方式是通过某个初步处置而使皮肤处于例如可以是大约3000欧姆的最优且更均匀的电阻值。然而，总是存在着电阻低的皮肤段且任何轻微出汗都可能将皮肤带至更低的阻抗。
图4是本顶端驱动电路的示范性实施例的示意性图解说明。图4的实施例消除或至少大大地降低可能影响所处置的受试者的痛觉和电击。例如4pF至10pF的低电容隔离变压器404定位成紧挨着具有电压至皮肤递送元件216的顶端212。在操作的过程中，变压器404降低或完全地消除由于在屏蔽体224和每个RF导线420和424之间由受试者皮肤320、324和地面形成的寄生电容408和412而导致的流经受试者身体的电流。管理所有装置设备的操作的控制器432可以位于壳体204中。控制器432可以具有对于控制处置过程而言必要的处理器、存储器以及其他设备。
图5是消除或大大地降低可能影响所处置的受试者的痛觉和电击的本顶端212驱动电路的另外的示范性实施例的示意性图解说明。除了低电容变压器404之外，位于电流路径中并串行连接至电极216的一个或多个电容502和504形成高通滤波器。在装置操作的过程中，高通滤波器将低频电流滤出，所处置的受试者对该低频电流的敏感性高，该低频电流由与皮肤320、324接触的电压至皮肤递送元件216处形成的等离子体生成，并且，在装置/施加器操作的过程中通过受试者身体而流动。可以参考Guidelinesfor Limiting Exposure to Time-Varying Electric，Magnetic，and ElectromagneticFields up to 300GHz；International Commission on Non-Ionizing RadiationProtection，第10页。
皮肤的电阻因受试者而异，并且，使用于美容皮肤处置的适当的RF能量值选择和RF能量的施加复杂化。进一步说，在RF能量的施加下，受试者的电阻可能变化。图6是以脉冲模式进行的RF能量的施加下的皮肤电阻变化的示意性图解说明。线602和606标记RF能量脉冲下的不同的皮肤行为，并且，线610和614标记导致期望的皮肤效果的皮肤电阻上限和皮肤电阻下限或阻抗值，尽管由于所处置的受试者皮肤性质的大的变化性，但可能需要实验性地设置匹配特定的受试者性质的其他值。如稍后所解释的，脉冲的长度可能从几毫秒变化至几百毫秒或甚至秒。
为了在处置之前建立适当的处置参数，***操作者或用户能够校准装置，并且，作为校准的结果而导出的操作处置参数载入到可以存储在控制器432的存储器中的查找表(LUT)中。出于校准的目的，对受试者和顶端行为进行建模的已知的可变电阻代替受试者而连接至RF电压源。在一个校准中，记录在不同的RF电压和不同的电阻值下流入电路的电流，并且，在另一个校准中，记录对不同的皮肤阻抗进行建模的施加至可变电阻的RF能量。
当皮肤湿时，其电阻低，并且，随着RF能量的施加，电阻继续下降(线606)。在不被具体理论约束的情况下，人们认为，施加至皮肤的大部分RF能量最初被浪费来干燥皮肤，并且，当RF能量的影响下的皮肤变干时，皮肤电阻开始增长至更高的值。电阻增加被认为是与汽化相联系，伴随着或跟随有组织消融。它被认为是当在电极下面的组织中创建消融时的良好的处置(期望的皮肤效果)。已经实验性地确定，导致期望的皮肤效果的处置发生在受试者的皮肤的电阻在R低和R高之间时，其中，具体值取决于顶端中的电极的数量和电极的布置，并且，取决于皮肤性质。对于具有64个电极且每个250μm的直径的图1中所示的典型的顶端，R低是大约1500欧姆，并且，R高是大约4000欧姆。对于图8的非对称顶端，R低是大约600欧姆，并且，R高是大约1600欧姆。当皮肤电阻(或阻抗)下降至低于下限时，大部分施加至皮肤的RF能量被浪费在干燥皮肤，而不是引起期望的皮肤效果。通常，皮肤电阻上限在角质层电阻的上下而下限对应于湿的皮肤。如折线610和614所示，当皮肤电阻处于所指示的电阻界限内时，通过电压至皮肤递送元件而进行的RF至皮肤的施加导致期望的皮肤效果。RF脉冲期间对皮肤阻抗的连续或伪连续监测使得能够控制递送至皮肤的能量。例如，当电阻下降至低于例如600欧姆的预设的阈值时，可以通过控制而增加RF脉冲的时间，直到控制单元识别或检测到电阻开始增加的为止。从检测到电阻开始增加的时间起，所递送的能量的量是固定的或考虑高达该点的所递送的能量，从而允许或确保适当的皮肤效果。也有可能在皮肤阻抗低于预设的阻抗或电阻值时切断RF脉冲并通知操作者，以排除无效的脉冲。另一个可能性是通知操作者低值皮肤电阻和需要干燥皮肤。也有可能将装置设置为将预设的量的能量递送至皮肤。
有可能将RF脉冲下的皮肤行为概括成至少两个典型的情况，尽管可能存在这些情况和其他皮肤行为的混合：a)在所有RF脉冲施加时间期间，皮肤电阻保持为高；和b)皮肤电阻下落至低于电阻下限，并且，在达到(函数达到)稳定水平之后，开始上升。因此，通过监测流入电压至皮肤递送元件电路的电流，从而有可能设置导致期望的皮肤效果且不引起诸如疼痛、烧伤及其他的不良副作用的适当的处置参数。发现高于R高的电阻与脏的顶端对应且/或由顶端至皮肤的不适当的附接引起。在这两种情况下，脉冲都可能引起不期望的疼痛。为了降低疼痛，在电阻高于某个预设的阈值时，限流器704(图7)或控制***立即切断脉冲。控制将通知操作者检查顶端至皮肤的适当的附接且/或清洁顶端。
图7是消除可能影响所处置的受试者的痛觉和电击的用于部分处置驱动电路的本顶端的另一示范性实施例的示意性图解说明。感测元件700感测最接近用于部分皮肤处置电路的顶端流动的电流。感测和采样可以是连续的或以非常短的时间间隔执行，例如每隔几十微秒。操作过程中的快速响应RF感应限流器704对流入皮肤中的电流设定最大值。立刻，随着电流增加至高于预设值，操作快速开关708以闭合电路从而将电流引导至能量吸收元件712，能量吸收元件712将过多的能量作为热而耗散。RF能量吸收元件712可以被封装或甚至是限流器704的一部分。开关可以是双极晶体管、MOSFET开关、IGBT开关或任何其他快速开关。如果在模拟的方式下操作开关，则能够使电流稳定在预设的最大值或低于该值。能量吸收元件712可以是一堆电阻器、二极管桥或类似的设备。这保护受试者免受电击、皮肤烧伤以及其他潜在的处置副作用。
图1图解说明现有技术的顶端，该顶端基本上是包括偶数和奇数阵列的电极的对称顶端。图8是消除或显著降低顶端电极之间的“竞争”的用于部分皮肤处置的本RF施加器顶端的示范性实施例的示意性图解说明。尽管顶端800是用于双极处置，但它是非对称顶端。顶端800具有位于基体808的周围区域并连接至一个RF输出端口的一个或多个(集群)大的“接地”电极804。从基体表面突起并以圆顶型形状终止的所有微型离散电压至皮肤施加元件812一起连接至RF输出变压器的其他端口。特定的顶端具有64个元件，尽管具有不同数量的元件的其他设计是可能的。该解决方案的进一步的优点是，电阻变化可以更明显，因为在位于偶数和奇数的接触带中的电极之间不存在竞争，因而防止皮肤上的不期望的部分痕迹和伴随的疼痛。电压至皮肤施加元件804的面积大体上大于由圆顶型形状元件812终止的面积。顶端800拥有实现顶端至施加器和RF电压连接元件(未显示)的迅速移除和附接的机构820。
上面公开的电方案和顶端结构消除电击感觉，降低或消除与处置相关联的疼痛并增加处置疗效。隔离变压器定位成非常接近施加顶端，以降低通过寄生电容的接地电流。位于至电极的路径中的串联电容器将由在电极处形成的等离子体产生的低频电流滤出，并且，快速限流器对流入皮肤中的电流设置最大值。
装置的典型的操作参数是：
高阻抗负载上的电压：850Vp-p
电流：50-400mA
脉冲长度：10-150msec
每个脉冲的能量(递送至皮肤的实际能量)：0.5-4J，更典型的1-2J。
RF的频率：1MHz，尽管可以考虑100kHz高至10MHz。
对于64个管脚且每个250微米的非对称顶端的典型的控制参数：
用于切断脉冲以便降低疼痛的高电阻界限：＞1600欧姆(对于64管脚的非对称顶端)
用于切断低效脉冲的低电阻界限：＜200欧姆(对于64管脚的非对称顶端)
控制添加能量以干燥皮肤的电阻的范围：200-600欧姆(对于64管脚的非对称顶端)

Claims (15)

1.一种用于部分RF皮肤处置的非对称顶端，所述顶端包括：
至少一个大电压至皮肤施加元件(804)和微型离散电压至皮肤施加元件(812)矩阵。
2.根据权利要求1所述的顶端，其中，所述大电压至皮肤施加元件(804)和所述微型离散电压至皮肤施加元件(812)矩阵形成在基体(808)上。
3.根据权利要求2所述的顶端，其中，所述大电压至皮肤施加元件(804)位于基体(808)的周围区域中。
4.根据权利要求1所述的顶端，其中，所述大电压至皮肤施加元件(804)的面积大体上大于所述微型离散电压至皮肤施加元件(812)矩阵的面积。
5.根据权利要求1所述的顶端，其中，所述大电压至皮肤施加元件(804)连接到RF输出变压器的一个端口，并且所述微型离散电压至皮肤施加元件(812)矩阵连接到所述RF输出变压器的另一端口。
6.根据权利要求1所述的顶端，其中，所述微型离散电压至皮肤施加元件(812)矩阵的各元件位于偶数和奇数排中。
7.根据权利要求1所述的顶端，其中，所述顶端是一次性顶端。
8.一种用于消除部分RF皮肤处置中的部分痕迹的顶端，所述顶端包括：
至少一个大电压至皮肤施加元件(804)，其连接到一个RF输出变压器端口；以及
微型离散电压至皮肤施加元件(812)矩阵，所述微型离散电压至皮肤施加元件(812)位于偶数和奇数排中并连接到所述RF输出变压器的另一端口；并且
其中，所述电压至皮肤施加元件连接消除位于偶数和奇数排中的所述电压至皮肤施加元件之间的竞争，并且所述处置不导致皮肤上不期望的部分痕迹以及伴随的疼痛。
9.根据权利要求8所述的顶端，其中，所述大电压至皮肤施加元件(804)和所述微型离散电压至皮肤施加元件(812)矩阵形成在共同基体(808)上，并且其中，所述大电压至皮肤施加元件(804)位于基体(808)的周围区域中。
10.根据权利要求8所述的顶端，其中，所述大电压至皮肤施加元件(804)的面积大体上大于所述微型离散电压至皮肤施加元件(812)矩阵的面积。
11.一种用于部分RF皮肤处置的施加器，所述施加器包括：
非对称顶端，其包括至少一个大电压至皮肤施加元件(804)和微型离散电压至皮肤施加元件(812)矩阵；
隔离RF变压器，其定位成紧挨着具有电压至皮肤递送元件的所述顶端；并且
其中，所述大电压至皮肤施加元件(804)连接到一个RF输出变压器端口，并且所述微型离散电压至皮肤施加元件(812)矩阵连接到所述隔离RF输出变压器的另一端口。
12.一种用于部分RF皮肤处置的施加器的一次性顶端，所述顶端包括：
-基体，其具有位于其上的：
至少一个大电压至皮肤施加元件，其连接到一个RF变压器输出端口；以及
电压至皮肤施加元件矩阵，其从所述基体的表面突起，并且所述元件的面积大体上小于所述至少一个大电压至皮肤施加元件的面积。
13.根据权利要求12所述的顶端，其中，所述基体是柔性或刚性基体。
14.一种用于防止部分RF皮肤处置中的电压至皮肤施加元件矩阵中的电压至皮肤施加元件之间的竞争的方法，所述方法包括：
将非对称顶端(800)放置为与皮肤段接触，所述顶端包括：
至少一个大电压至皮肤施加元件(804)，其连接到一个RF变压器输出端口；以及
微型离散电压至皮肤施加元件(812)矩阵，其连接到另一RF变压器输出端口，所述微型离散电压至皮肤施加元件(812)位于偶数和奇数接触带中；
提供RF能量至所述电压至皮肤施加元件(804，812)；并且
其中，消除位于所述偶数和奇数接触带中的所述电压至皮肤施加元件之间的竞争，并且所述处置不导致皮肤上不期望的部分痕迹以及伴随的疼痛。
15.一种用于消除部分RF皮肤处置中的皮肤上的部分痕迹的方法，所述方法包括：
将非对称顶端(800)放置为与皮肤段接触，所述顶端包括：
至少一个大电压至皮肤施加元件(804)，其连接到一个RF输出变压器端口；以及
微型离散电压至皮肤施加元件(812)矩阵，所述微型离散电压至皮肤施加元件(812)连接到所述RF输出变压器的另一端口；
提供RF能量至所述电压至皮肤施加元件(804，812)；并且
其中，所述电压至皮肤施加元件连接消除(位于偶数和奇数接触带中的)所述电压至皮肤施加元件之间的竞争，并且所述处置不导致皮肤上不期望的部分痕迹以及伴随的疼痛。
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