CN203539875U - Skin treatment equipment - Google Patents
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Abstract
本实用新型提供了家用的皮肤治疗设备,该设备包括:能够应用于使用者的皮肤的线性布置的多个电极;射频(RF)发生器,其被布置为经由电极将射频能量传送到皮肤;以及控制单元,其被布置为:根据指定传输方案控制由射频发生器到皮肤的射频能量传送,指定传输方案包括控制相对电极极性以使所传送的射频能量集中到指定皮肤体积。该设备具有增强的安全特性和改进的操作效率。RF能量在严格的控制下被传送到皮肤的相对小而良好的局部化的体积,避免皮肤表面的过度加热。表面加热是由直接温度测量和由该设备的运动监测两者进行监控,以确保适当使用和防止皮肤过热和与之相关的疼痛。
The utility model provides a skin treatment device for home use, the device comprising: a plurality of electrodes in a linear arrangement that can be applied to the skin of a user; a radio frequency (RF) generator arranged to transmit radio frequency energy to the skin via the electrodes; and a control unit arranged to: control delivery of radiofrequency energy from the radiofrequency generator to the skin according to a prescribed delivery scheme, the prescribed delivery scheme including controlling relative electrode polarities to focus the delivered radiofrequency energy to a prescribed skin volume. The device features enhanced safety features and improved operational efficiency. RF energy is delivered to a relatively small, well localized volume of skin under tight control, avoiding excessive heating of the skin surface. Surface heating is monitored both by direct temperature measurement and by motion monitoring of the device to ensure proper use and prevent skin overheating and the pain associated therewith.
Description
技术领域 technical field
本实用新型涉及皮肤治疗领域,且更具体地,涉及射频(RF)皮肤治疗。 The utility model relates to the field of skin treatment, and more particularly, to radio frequency (RF) skin treatment. the
背景技术 Background technique
相关申请的交叉引证 Cross-references to related applications
本申请是2013年4月18日提交的美国专利申请No.13/865658的部分的继续,其是2010年6月7日提交的美国专利申请序列No.12/802,518的继续,其根据35U.S.C.§119要求2009年6月5日提交的美国临时专利申请No.61/213,409和2009年6月5日提交的美国临时专利申请No.6/213,410的优先权。美国专利申请序列No.12/802,518也是2007年1月17日提交的美国专利申请序列No.11/654,914(现在美国专利申请No.8,206,381)的部分继续申请,其根据35U.S.C.§119要求2006年1月17日提交的美国临时专利申请No.60/759,289和2006年2月17日提交的美国临时专利申请No.60/774,167的优先权。本申请也因此要求美国专利No.8,206,381和其每个优先临时专利申请的优先权。因此,每个这样说明的申请通过引证将其整体内容结合于此。此申请进一步要求2012年6月28日提交的美国临时专利申请No.61/665,552的利益,通过引证将其整体内容结合于此。 This application is a continuation-in-part of U.S. Patent Application Serial No. 13/865658, filed April 18, 2013, which is a continuation of U.S. Patent Application Serial No. 12/802,518, filed June 7, 2010, under 35U. S.C. §119 claims priority to U.S. Provisional Patent Application No. 61/213,409, filed June 5, 2009, and U.S. Provisional Patent Application No. 6/213,410, filed June 5, 2009. U.S. Patent Application Serial No. 12/802,518 is also a continuation-in-part of U.S. Patent Application Serial No. 11/654,914 filed January 17, 2007 (now U.S. Patent Application No. 8,206,381), which is required under 35 U.S.C. §119 of 2006 Priority to U.S. Provisional Patent Application No. 60/759,289, filed January 17, 2006, and U.S. Provisional Patent Application No. 60/774,167, filed February 17, 2006. This application also hereby claims priority to US Patent No. 8,206,381 and each of its priority provisional patent applications. The entire content of each such described application is hereby incorporated by reference. This application further claims the benefit of US Provisional Patent Application No. 61/665,552, filed June 28, 2012, which is hereby incorporated by reference in its entirety. the
能量发射设备通常用于加热皮肤或皮下组织或触发非热化学或光化学反应。在许多情况下,应该限制表皮的加热,以防止皮肤灼伤。这反过 来限制传送到更深组织的能量的量。在专业诊所中,能量发射皮肤治疗设备使用皮肤冷却来防止表皮过热。由于高的成本和包括这样功能的设备的大小,主动冷却在消费者、家用设备中是不实用的。 Energy-emitting devices are commonly used to heat the skin or subcutaneous tissue or to trigger non-thermochemical or photochemical reactions. In many cases, heating of the epidermis should be limited to prevent skin burns. This in turn limits the amount of energy delivered to deeper tissues. In specialty clinics, energy-emitting skin therapy devices use skin cooling to keep the epidermis from overheating. Active cooling is impractical in consumer, home devices due to the high cost and size of the devices including such functionality. the
美国专利No.8,206,381(通过引证将其整体内容结合于此)公开了用于应用相位控制RF能量到治疗部位的电手术设备。 US Patent No. 8,206,381 (herein incorporated by reference in its entirety) discloses an electrosurgical device for applying phase controlled RF energy to a treatment site. the
实用新型内容 Utility model content
本实用新型的一个方面提供一种皮肤治疗设备,包括:多个能够应用于使用者的皮肤的线性布置(linearly arranged)的电极;射频(RF)发生器,其被布置为经由电极将RF能量传送到皮肤;以及控制单元,其被布置为根据指定(specified,规定的)传输方案(transmission plan)和/或指定安全方案控制由RF发生器到皮肤的RF能量传送。控制单元被布置为:根据指定传输方案控制由射频发生器进行的到皮肤的射频能量传送,指定传输方案包括控制相对电极极性以使所传送的射频能量集中到指定皮肤体积。 One aspect of the present invention provides a skin treatment device comprising: a plurality of linearly arranged electrodes that can be applied to the skin of a user; a radio frequency (RF) generator arranged to channel RF energy via the electrodes transmission to the skin; and a control unit arranged to control the transmission of RF energy from the RF generator to the skin according to a specified transmission plan and/or a specified safety plan. The control unit is arranged to control delivery of radiofrequency energy to the skin by the radiofrequency generator according to a prescribed delivery scheme, including controlling relative electrode polarities to focus the delivered radiofrequency energy to a given skin volume. the
进一步地,相对电极极性被控制以产生具有基本相同极性的一对或两对相邻电极。 Further, opposing electrode polarities are controlled to produce one or two adjacent pairs of electrodes having substantially the same polarity. the
进一步地,指定传输方案被配置以使皮肤的表面保持低于指定温度阀值。 Further, the prescribed delivery regimen is configured to maintain the surface of the skin below a prescribed temperature threshold. the
进一步地,皮肤治疗设备进一步包括流体分配器,该流体分配器被布置为在致动时将流体分配到皮肤上。 Further, the skin treatment device further comprises a fluid dispenser arranged to dispense fluid onto the skin when actuated. the
进一步地,皮肤治疗设备进一步包括:温度传感器,该温度传感器被定位在电极的附近;以及运动传感器,该运动传感器被布置为测量电极相对于皮肤的运动,其中控制单元被进一步布置为:根据被设计为在由不熟 练的使用者操作设备时防止指定皮肤表面区域过热的指定安全方案,相对于从温度传感器和运动传感器获得的测量结果来控制射频能量传送。 Further, the skin treatment device further comprises: a temperature sensor positioned in the vicinity of the electrode; and a motion sensor arranged to measure movement of the electrode relative to the skin, wherein the control unit is further arranged to: A specified safety protocol designed to prevent overheating of specified skin surface areas when the device is operated by an unskilled user controls RF energy delivery relative to measurements obtained from temperature sensors and motion sensors. the
进一步地,控制单元被进一步布置为;在检测到来自温度传感器和运动传感器中的至少一个的无变化测量结果时,停止能量传送。 Further, the control unit is further arranged to stop the energy delivery upon detection of no change measurement from at least one of the temperature sensor and the motion sensor. the
进一步地,温度传感器将电极分成两组,两组中的一组包括具有相同极性的相邻的一对电极。 Further, the temperature sensor divides the electrodes into two groups, and one of the two groups includes a pair of adjacent electrodes with the same polarity. the
进一步地,指定安全方案包括:在检测到高于规定阀值的温度测量结果或者在比指定持续时间更长的时间段内缺少运动时,停止射频能量传送。 Further, specifying a safety protocol includes ceasing radio frequency energy delivery upon detection of a temperature measurement above a specified threshold or lack of motion for a period longer than a specified duration. the
进一步地,皮肤治疗设备进一步包括被布置为指示检测的指示器。 Further, the skin treatment device further comprises an indicator arranged to indicate detection. the
进一步地,温度传感器包括从流体分配器施加到皮肤上的温度敏感流体。 Further, the temperature sensor includes a temperature sensitive fluid that is applied to the skin from a fluid dispenser. the
进一步地,皮肤治疗设备进一步包括至少一个另外的温度传感器。 Further, the skin treatment device further comprises at least one further temperature sensor. the
进一步地,运动传感器是定位在设备内的加速计。 Further, the motion sensor is an accelerometer positioned within the device. the
本实用新型还提供了一种皮肤治疗方法,包括根据指定传输方案经由多个线性排列的电极将RF能量传送到使用者的皮肤,所述指定传输方案包括控制相对电极极性以使所传送的RF能量集中到指定皮肤体积。 The present invention also provides a skin treatment method, comprising delivering RF energy to the user's skin via a plurality of linearly arranged electrodes according to a prescribed delivery scheme, the prescribed delivery scheme including controlling the polarity of the opposing electrodes so that the transmitted RF energy is focused to a given skin volume. the
进一步地,相对电极极性被控制以产生一对或两对具有基本相同极性的相邻电极。 Further, opposing electrode polarities are controlled to produce one or two pairs of adjacent electrodes having substantially the same polarity. the
进一步地,指定传输方案被配置以使皮肤的表面保持低于指定温度阀值。 Further, the prescribed delivery regimen is configured to maintain the surface of the skin below a prescribed temperature threshold. the
进一步地,该方法进一步包括:测量在电极附近的皮肤温度;测量电极的运动;以及根据为防止在由不熟练的使用者执行RF能量传送时指定皮肤表面区域过热而设计的指定安全计划,相对于测量结果控制RF能量传送。 Further, the method further comprises: measuring skin temperature in the vicinity of the electrodes; measuring movement of the electrodes; and relative RF energy delivery is controlled based on the measurement results. the
进一步地,指定安全计划被进一步设计为在检测到无变化的温度或运动测量结果时停止能量传送。 Further, the specified safety plan is further designed to stop energy delivery when no change in temperature or motion measurements is detected. the
进一步地,指定安全计划被进一步设计为在下列至少一个时停止RF能量传送:高于指定阀值的温度测量结果和在比指定持续时间更长的时间段内缺少运动。 Further, the specified safety plan is further designed to stop RF energy delivery upon at least one of: a temperature measurement above a specified threshold and lack of motion for a period longer than a specified duration. the
进一步地,该方法进一步包括指示下列至少一个:接近指定阀值的测得的温度和接近指定持续时间的缺少运动的时间段。 Further, the method further includes indicating at least one of: a measured temperature near a specified threshold and a period of lack of motion near a specified duration. the
本实用新型还提供了一种皮肤治疗设备,该皮肤治疗设备包括:多个线性布置的电极,这些电极能够应用于使用者的皮肤;射频(RF)发生器,该射频发生器被布置为经由电极将射频能量传送到皮肤;温度传感器,该温度传感器被定位在电极的附近;运动传感器,该运动传感器被布置为测量电极相对于皮肤的运动;以及控制单元,该控制单元被布置为:根据指定传输方案控制由射频发生器进行的到皮肤的射频能量传送,指定传输方案包括控制相对电极极性以产生具有基本相同极性的一对或两对相邻电极,以使所传送的射频能量集中到指定皮肤体积并且将皮肤的表面保持低于指定温度阀值;以及根据被设计为在由不熟练的使用者操作设备时防止指定皮肤表面区域过热的指定安全方案,相对于从温度传感器和运动传感器获得的测量结果来控制射频能量传送,从而在检测到下列情况中的至少一种时停止能量传送:高于指定阀值的温度测量结果;在比指定持续时间更长的时间段内缺少运动;以及来自温度传感器和运动传感器中的至少一个的无变化的测量结果。 The present invention also provides a skin treatment device comprising: a plurality of linearly arranged electrodes capable of being applied to the user's skin; a radio frequency (RF) generator arranged to transmit via The electrodes deliver radiofrequency energy to the skin; a temperature sensor positioned in the vicinity of the electrodes; a motion sensor arranged to measure movement of the electrodes relative to the skin; and a control unit arranged to: The delivery of radiofrequency energy to the skin by the radiofrequency generator is controlled by a prescribed delivery scheme, which includes controlling opposing electrode polarities to create one or two adjacent pairs of electrodes having substantially the same polarity so that the delivered radiofrequency energy concentrating to a specified skin volume and maintaining the surface of the skin below a specified temperature threshold; and in accordance with a specified safety protocol designed to prevent overheating of the specified skin surface area when the device is operated by an unskilled user, relative to temperature sensors and Measurements obtained by motion sensors are used to control RF energy delivery, thereby stopping energy delivery when at least one of the following conditions is detected: a temperature measurement above a specified threshold; motion; and an unchanged measurement from at least one of the temperature sensor and the motion sensor. the
本实用新型的这些、另外的和/或其他方面和/或优点在下列详细说明中详尽解释;可能从详细说明中是能推理的;和/或通过本实用新型的实践是可学习的。 These, additional and/or other aspects and/or advantages of the present invention are fully explained in the following detailed description; may be inferred from the detailed description; and/or are learnable by practice of the present invention. the
附图说明 Description of drawings
为了更好地理解本实用新型的实施例和说明如何可以实行相同的实施例,现在仅通过示例的方式参照附图,在全部附图中同样标号表示同样元件或部分。 For a better understanding of embodiments of the present invention and to illustrate how the same may be practiced, reference is now made, by way of example only, to the accompanying drawings, wherein like numerals refer to like elements or parts throughout. the
在附图中: In the attached picture:
图1和图3是根据本实用新型的一些实施例的皮肤治疗设备的高水平示意性透视图; Figures 1 and 3 are high level schematic perspective views of skin treatment devices according to some embodiments of the present invention;
图2A是根据本实用新型的一些实施例的皮肤治疗设备的高水平示意性方框图; Figure 2A is a high level schematic block diagram of a skin treatment device according to some embodiments of the present invention;
图2B是根据本实用新型的一些实施例的皮肤治疗设备中的电极布置的高水平示意图; Figure 2B is a high level schematic illustration of an electrode arrangement in a skin treatment device according to some embodiments of the present invention;
图4是根据本实用新型的一些实施例的皮肤治疗设备的操作原理的高水平示意图; Figure 4 is a high level schematic illustration of the principles of operation of a skin treatment device according to some embodiments of the present invention;
图5A至图5G是基于模拟和定性地呈现了电极配置和估计产生的电流分布的高水平图示;以及 Figures 5A-5G are high-level illustrations based on simulations and qualitatively presenting electrode configurations and estimated resulting current distributions; and
图6A和图6B分别是根据本实用新型的一些实施例说明一种皮肤治疗方法的高水平示意性流程图的前部分和后部分。 6A and 6B are the front and back parts, respectively, of a high-level schematic flowchart illustrating a method of skin treatment according to some embodiments of the present invention. the
具体实施方式 Detailed ways
在详尽解释具体实施方式之前,详尽解释在下文中将会使用的一些术语的定义可能是有帮助的。 Before explaining the specific embodiments in detail, it may be helpful to explain in detail the definitions of some terms that will be used hereinafter. the
在本申请中,这里所用的术语“皮肤治疗(skin treatment)”是指任何类型的皮肤治疗,如皮肤加热、治疗皱纹、通过胶原重塑治疗皮肤老化、治疗皮肤疾病(如痤疮和牛皮癣)、治疗皮肤粗糙、治疗皮肤色素沉着、皮肤脱皮、表皮嫩肤或提供任何其他治疗效果。 In this application, the term "skin treatment" as used herein refers to any type of skin treatment such as skin heating, treatment of wrinkles, treatment of skin aging by collagen remodeling, treatment of skin diseases such as acne and psoriasis, Treating rough skin, treating skin hyperpigmentation, skin peeling, epidermal rejuvenation, or providing any other therapeutic effect. the
在本申请中,这里所用的术语“相位(phase)”是指波动电流或电压的相对角的任何值。如在本申请中这里所用的,所传送的电流或电压的术语“相位控制(phase control)”或“控制相位(controlling the phase)”是指设置一个特定相位值到所传送的电流或电压。所述特定相位值可以是从0°至360°(0至2π弧度)的任何值。如在本申请中这里所用的,电极之间的术语“相对相位(relative phase)”是指电极之间的任何相位差,包括零相位差。 In this application, the term "phase" as used herein refers to any value of the relative angle of the fluctuating current or voltage. As used herein in this application, the term "phase control" or "controlling the phase" of a delivered current or voltage means setting a specific phase value to the delivered current or voltage. The specific phase value may be any value from 0° to 360° (0 to 2π radians). As used herein in this application, the term "relative phase" between electrodes refers to any phase difference between electrodes, including zero phase difference. the
如在本申请中这里所用的,与电极有关的术语“极性(polarity)”是指电极相对于电流传送是正极或负极。如在本申请中这里所用的,参照两个电极,术语“相同极性(same polarity)”是指所述两个电极在大部分时间具有相同极性,即,两个电极处于相同极性比它们处于相反极性时间更长,或者,通过使用相位术语,具有在+90°与-90°(-π/2至+π/2弧度)之间的相位差。如在本申请中这里所用的符号+和-是指就上面解释来说,电极极性示意性地指定那些电极具有相同极性。具有相同符号的电极之间的相位可以是零,但也可以具有在+90°与-90°(-π/2至+π/2弧度)之间的任何值。在所述+和-组中的不同电极可以具有在其之间的不同相位差值。在每个所述+和-组中的一些或所有电极可具有在其之间的零相位差。 As used herein in this application, the term "polarity" in relation to an electrode refers to whether the electrode is positive or negative with respect to current delivery. As used here in this application, with reference to two electrodes, the term "same polarity" means that said two electrodes have the same polarity most of the time, i.e., both electrodes are at the same polarity ratio They are in opposite polarity for longer, or, to use phase terminology, have a phase difference between +90° and -90° (-π/2 to +π/2 radians). The symbols + and − as used here in this application mean that electrode polarity schematically designates those electrodes having the same polarity as far as the above explanation is concerned. The phase between electrodes with the same sign can be zero, but can also have any value between +90° and -90° (-π/2 to +π/2 radians). Different electrodes in the + and - groups may have different phase difference values between them. Some or all electrodes in each of the + and - groups may have zero phase difference between them. the
现在具体详细地参考附图,强调的是,所示出的详情是通过举例的方式和仅为了本实用新型的优选实施例的说明性讨论的目的,并且为提供所认为的最有用和最容易理解本实用新型的原理和概念方面的说明而呈现。 在这方面,不尝试比基本理解本实用新型所需的更详细示出本实用新型的结构细节,与附图结合的描述使本领域的技术人员显而易见的是,本实用新型的几种形式如何可以在实践中实现。 Referring now in particular to the drawings in detail, it is emphasized that the particulars shown are by way of example and for purposes of illustrative discussion of preferred embodiments of the invention only, and to provide what is believed to be the most useful and easiest An explanation is presented for understanding the principles and conceptual aspects of the invention. In this regard, no attempt has been made to show structural details of the invention in more detail than is necessary for a basic understanding of the invention, and the description in conjunction with the accompanying drawings will make apparent to those skilled in the art how the invention can take several forms. can be achieved in practice. the
在详细解释本实用新型的至少一个实施例之前,应当理解的是,本实用新型在其申请中并不限于在下列描述中详尽解释的或在附图中示出的结构细节和部件的布置方式。本实用新型能够应用于其他实施例或以各种方式实践或实行。另外,应当理解的是,这里所采用的措辞或术语是为了描述的目的,且不应该被认为是限制性的。 Before explaining at least one embodiment of the present invention in detail, it should be understood that the present invention is not limited in its application to the details of construction and the arrangement of components explained in the following description or shown in the accompanying drawings . The invention can be applied to other embodiments or practiced or carried out in various ways. Also, it is to be understood that the phraseology or terminology employed herein is for the purpose of description and should not be regarded as limiting. the
本实用新型的实施例提供一种具有增强的安全特性和改进的操作效率的家用皮肤治疗设备。RF(射频)能量在严格控制下传送到皮肤的相对小的和良好的局部化体积,避免皮肤表面的过度加热。表面加热是由直接温度测量和由设备的运动监测来进行监控,以确保适当使用和防止皮肤过热和与之相关的疼痛。所呈现的设备和方法允许在消费者、家庭环境下能量传送到皮肤的较安全和更有效的实施。 Embodiments of the present invention provide a home skin treatment device with enhanced safety features and improved operating efficiency. RF (Radio Frequency) energy is delivered to a relatively small and well localized volume of the skin under tight control, avoiding excessive heating of the skin surface. Surface heating is monitored by direct temperature measurement and motion monitoring by the device to ensure proper use and prevent skin overheating and associated pain. The presented devices and methods allow for safer and more efficient implementation of energy delivery to the skin in consumer, home settings. the
图1和图3是根据本实用新型的一些实施例的皮肤治疗设备100的高水平示意性透视图;图2A是根据本实用新型的一些实施例的皮肤治疗设备100的高水平示意性方框图;以及图2B是根据本实用新型的一些实施例的皮肤治疗设备中的电极布置的高水平示意图。可以设计设备100来可控制地加热特定皮肤体积,同时保持皮肤的表面低于指定温度阀值。
Figures 1 and 3 are high level schematic perspective views of a
皮肤治疗设备100包括多个能够应用于使用者皮肤的电极110。电极110可以是线性布置的。设备100的壳体101可以被布置为保持电极110和电子电路(如下文所述)。壳体101可符合人体工程学设计,例如,以类似画笔的连续方式应用所述治疗。壳体101可包括保证电极110与皮肤接触的机构。设备100可由按钮102来进行操作。设备100可被布置为通过在不同模式(重复地、连续地等)下按下按钮102在不同强度下操作。
The
皮肤治疗设备100进一步包括射频(RF)发生器130,其被布置为通过电极110传送RF能量到皮肤。RF发生器130可以由外部电源90、内部电源、感应电源等供电。RF发生器130可以由RF电压调节器160调节和由控制单元150(如微控制器)控制。控制单元150可以与触发器155和低电压调节器92关联。
The
皮肤治疗设备100进一步包括控制单元150,该控制单元被布置为根据指定传输方案控制由RF发生器130进行的RF能量传送到皮肤。控制单元150可经进一步布置控制每个电极的相位和协调电极的极性。因此,控制单元150可被布置为在任何两个电极之间设置任何指定相位,以准确地控制能量传送到皮肤。特别地,控制单元150可指定反极性到电极的子组,如由符号+和-在下面表示。如上所述,反极性可能是近似的(即,不一定是180°,也可以是例如120°或160°等)。可以在操作过程中预先确定和控制电极之间的相位差。所述传输方案可包括控制相对电极极性(relative electrode polarities),以集中所传送的RF能量到指定皮肤体积。例如,所述相对电极极性可被控制以产生一对或两对具有基本相同极性的相邻电极110(见下面的示例)。
The
在实施例中,电极110A-110F都是通过变压器135或单个发生器130而连接。这样的配置可能在家用设备中是实用的,因为其只需要单个发生器和利用每对的两个电极(在专业诊所中使用的商用设备通常具有多个发生器并通常接地,以便只有每对电极中的一个电极接触皮肤)。在实施例中,电极110A-110F中的一些电极可以连接在一起,以根据下面解释的原理改进电流传送和加热。因此,具有规定数量电极的设备100可用于通过相互连接一些电极经由较小数量的电极传送RF能量。与四个电极配置和六个电极配置有关的下列示例应该以非限制性方式解释为与任何数量的电极有关。
In an embodiment, the
图4是根据本实用新型的一些实施例的皮肤治疗设备100的操作原理的高水平示意图。线性布置的电极110以其布置顺序110A-110F表示在皮 肤80上。指定电极极性为+--+-+,这是唯一配置(从可能的配置,即:+-+-+-;+--+-+;+--++-;+-++--;++-+--;+++---,在从左到右和从+到-对称的应用下),这呈现了所有而不是一对相邻电极110的交替极性。在所示的情况下,具有相同极性的所述一对相邻电极是电极110B、110C。在实施例中,设备100可包括两对、三对、四对或更多对电极110。
Figure 4 is a high level schematic illustration of the principles of operation of
图5A至图5G是基于模拟和定性地呈现了电极配置和估计产生的电流分布的高水平图示。 Figures 5A-5G are high level illustrations based on simulations and qualitatively presenting electrode configurations and estimated resulting current distributions. the
图4示意性地示出了以分别与电极110A-110F有关的示意性电流标号111A-111F的形式传送到皮肤的RF能量。示意性地,正电极110A、110D、110F发出电流,且负电极110B、110C、110E接收电流,明确地电极极性连续波动使得电流111连续地改变方向和大小,所以图4应该被视为非限制性解释说明。每个电极电流是由两个电流符号表示,以示意性地示出所述电极之间的关系。发明人已经投入大量研究来研究可能的电极配置,并且来示出所呈现的配置使得RF能量主要传送到在一对具有相同极性的电极110B、110C下面的相对小的皮肤体积。加热皮肤体积的有效能量是由箭头112示出。所传送的热量是由可变光栅密度(基于三维麦克斯韦模拟)示意性地示出,这示出了能量在电极110B、110C下面的清楚集中。图4是由所呈现的电极配置导出的实验数据的示意性表示。
Figure 4 schematically illustrates RF energy delivered to the skin in the form of schematic
在不希望被理论束缚的情况下,理解电极110的空间配置和相位配置,以在给定皮肤特性下确定所治疗的皮肤的加热模式。特别地,由于较大电流趋向于流过较低阻抗的区域,控制电极110的相位和极性允许控制组织加热的程度。例如,具有相同极性的两个相邻电极(即,基本彼此同相的电极)中的每个都增加其他电极在电极之间的组织区域处经历的阻抗。因此,具有相同极性的各对电极创建在电极之间具有增加的阻抗的电位壁垒(electrical potential barrier,电势垒)113。壁垒113趋向于驱动与所述一对电极关联的电流更深地进入皮肤组织(例如,以皮肤表面成一角度),因为所增加的阻抗更接近电极,从而更接近表面。
Without wishing to be bound by theory, the spatial and phase configurations of
图5A和图5B示出了具有四个电极的两个配置。在每个配置中,两对电极具有相同极性。如图5A中所示,当极性在电极之间交替时,所形成的电流和所产生的加热在皮肤中是相对较浅的,因为每个电极具有带反极性的相邻电极。另一方面,如图5B中所示,当电极被布置成两对相同极性时,在每个这样一对电极之间形成阻抗壁垒113,并且电流更深地穿透至皮肤中。
Figures 5A and 5B show two configurations with four electrodes. In each configuration, both pairs of electrodes have the same polarity. As shown in Figure 5A, when the polarity is alternated between the electrodes, the resulting electrical current and resulting heating is relatively shallow in the skin because each electrode has an adjacent electrode of opposite polarity. On the other hand, as shown in FIG. 5B , when the electrodes are arranged in two pairs of the same polarity, an
图5C-5G示出了六个电极的可能配置,示意性地分别表示为+-+-+-、+--+-+、+-++--、+++---和++-+--。应注意的是,由于对称的原因,反转一个配置中的所有极性产生等效配置(因为RF电流波动)和反转电极的顺序也产生等效配置(因为该设备可以用于任一方向)。 Figures 5C-5G show possible configurations of six electrodes, schematically denoted as +-+-+-, +--+-+, +-++--, +++--- and ++, respectively -+--. It should be noted that for reasons of symmetry, reversing all polarities in one configuration yields an equivalent configuration (because the RF current fluctuates) and reversing the order of the electrodes also yields an equivalent configuration (because the device can be used in either orientation ). the
图5C和图5F的配置增强了分别对图5A和图5B中所示的四个电极配置在上面所讨论的效果。图5C中所示的配置产生浅电流和浅加热,而图5F中所示的配置不但由于多个增加的阻抗壁垒113产生深电流,而且由于来自所有对的电极的电流的会聚(convergence)在区域114处产生强烈的表面加热。图5E和5G示出了具有两个阻抗壁垒的两个配置,两个都产生导致皮肤组织深加热的深电流。然而,图5G中所示的配置产生强烈的表面加热,因为增加的阻抗壁垒113是横向的并且电流朝向配置的中心集中。最后,图5D示出了一个具有单一增加的阻抗壁垒113的配置,该单一增加的阻抗壁垒足够产生深电流和加热,但避免强烈的表面加热。此配置的模拟结果详细示于图4中,并清楚地示出这种配置的效率。
The configurations of Figures 5C and 5F enhance the effects discussed above for the four electrode configurations shown in Figures 5A and 5B, respectively. The configuration shown in Figure 5C produces shallow current flow and shallow heating, while the configuration shown in Figure 5F not only produces deep current flow due to multiple increased
上面所述的配置是具有四个和六个电极的配置的非限制性示例。它们不被视为限制电极的数量,但指示较大数量的电极的合理配置。 The configurations described above are non-limiting examples of configurations with four and six electrodes. They are not considered to limit the number of electrodes, but indicate a reasonable configuration for a larger number of electrodes. the
在实施例中,控制单元150可经进一步布置得到皮肤阻抗的实时估计和根据所估计的皮肤阻抗调整所传送的能量,从而导致更加可预测的结果。皮肤阻抗估计可以从测量相对于所应用的电压的能量传送中得到(皮肤阻抗随治疗的皮肤体积而增加)。不同能量传送参数可以应用于治疗不 同皮肤区域(例如,在脸上,眼部区域的特征是在1mm范围内的薄的皮肤,而脸颊区域的特征是在3-4mm范围内的薄的皮肤)。
In an embodiment, the
在实施例中,皮肤治疗设备100可进一步包括:温度传感器120,其定位在电极110附近;和运动传感器140,其被布置为测量相对于皮肤的电极110的运动。运动传感器140可被布置为通过测量整个设备100的运动来测量电极运动。例如,运动传感器140可以是加速计。在实施例中,控制单元150可根据为防止在由不熟练的使用者操作设备100时指定皮肤表面区域过热而设计的指定安全方案,相对于从温度传感器和运动传感器获得的测量结果进一步控制RF能量传送。例如,控制单元150可被布置为在检测到来自温度传感器120和运动传感器140中的至少一个的无变化测量结果时停止能量传送。这样可指示传感器120、140中的一个发生故障,或设备100的不适当使用(例如,由于缺乏技能)。由于这些情况中的任一个都可能伤害使用者,因此能量传送被停止。
In an embodiment, the
可替代地或另外地,指示器(未示出)可被布置为指示无变化测量结果和指示解决这样问题的可能的使用者操作。在实施例中,所述安全方案可能经设计产生足够的热效应来诱导胶原重塑,同时避免表皮、真皮或皮下组织的任何烧蚀热损伤。在实施例中,所述指示器可以是使用者界面(未示出)的一部分,包括例如:LED指示器,其让使用者知道设备100可以使用;闪烁的LED,其指示有源RF发射;计时器,其在预先确定的时间段(例如,在约1到10分钟之间、在1与4分钟之间,和约4分钟,以及类似时间段)之后停止RF发射;听觉和/或振动信号装置(例如,移动手机振动机构、扬声器等),其例如发出每个区域的治疗时间结束(例如,4分钟)的信号给使用者。
Alternatively or additionally, an indicator (not shown) may be arranged to indicate a no-change measurement and to indicate a possible user action to resolve such a problem. In embodiments, the safety protocol may be designed to generate sufficient thermal effect to induce collagen remodeling while avoiding any ablative thermal damage to the epidermis, dermis or subcutaneous tissue. In an embodiment, the indicators may be part of a user interface (not shown) including, for example: LED indicators, which let the user know that the
在实施例中,温度传感器120可将电极110分成两组,其中一组包括相邻一对具有相同极性的电极(例如,110B、110C)。电极110和温度传感器120可布置成与中心温度传感器在一条线上。所述指定传输方案可经 设计使传送到在两个电极组之一下面的指定皮肤体积的RF能量最大化。在实施例中,设备100可包括另外的温度传感器。
In an embodiment, the
运动传感器140和温度传感器120的组合克服了与仅使用温度传感器关联的几个问题。这样的问题包括温度传感器的相对长的反应时间(可能在反应时间内发生损坏)和在治疗过程中在没有经受最高温度的位置处的测量(由于与电极分开的传感器位置和设备运动)。由运动传感器140监控设备运动通过确保实际加热(通过移动电极110)和温度测量(通过测量所有加热区域)两者的中和补偿这样的问题。除了运动传感器140之外使用温度传感器120克服与仅使用运动传感器关联的几个问题,特别是缺少温度监控。此外,对独立参数的测量使得对于皮肤特征(例如,皮肤厚度和阻抗)和能量传送参数的效果变化性具有更强的坚固性。这种坚固性在家庭使用中特别重要。
The combination of
在实施例中,所述指定安全方案可被配置以使皮肤的表面保持低于指定温度阀值,例如,所述指定安全方案可包括在检测到高于指定阀值(例如,42.5℃或43℃)的温度测量结果或在比指定持续时间更长的时间段内缺乏运动时停止RF能量传送。皮肤治疗设备100可进一步包括被布置为指示检测到这种测量结果的指示器(未示出)。
In an embodiment, the specified safety protocol may be configured to keep the surface of the skin below a specified temperature threshold, for example, the specified safety protocol may include detecting temperature above a specified threshold (e.g., 42.5° C. or 43 °C) or when there is a lack of motion for a period longer than the specified duration, RF energy delivery will cease. The
在实施例中,可以在用设备100的皮肤治疗过程中使用流体或凝胶,以促进下列中的任何一个:更好的皮肤治疗、更好的热分散、到电极的更好的电接触、皮肤冷却等。在实施例中,设备100可进一步包括流体分配器180,该流体分配器被布置为在致动时分配流体、凝胶或乳膏在皮肤上。在实施例中,可以由除了施加在皮肤上或涂到温度传感器120的温度敏感流体来实行温度测量。在实施例中,温度传感器可实施作为温度敏感流体,例如,温度敏感流体可以在达到指定温度时改变颜色。颜色变化可以由设备感测,或者提供一个指示给使用者以暂停治疗。温度敏感流体可以由使用者涂敷或从流体分配器180分配。
In embodiments, fluids or gels may be used during skin treatment with
流体分配器180可包括致动器,该致动器被布置为由使用者或自动地由设备100根据各种治疗参数(例如,治疗区域、运动强度、所传送的能量、经过时间、测得的温度)释放指定量的流体。控制单元150可以根据任一传感器120、140的测量结果来释放流体。
在实施例中,凝胶可以是磨皮凝胶,磨皮凝胶可用作确保适当能量(例如,RF)传送到组织的接触增强剂以及用于表皮嫩肤的活性磨皮化合物。可以由装置100通过加热来增强磨皮效果,例如,加热凝胶中的砂状颗粒可以增强其磨蚀和清洁性能。
In an embodiment, the gel may be a dermabrasion gel, which may be used as a contact enhancer to ensure proper energy (eg, RF) delivery to tissue as well as an active dermabrasion compound for epidermal rejuvenation. The effect of microdermabrasion can be enhanced by heating the
在实施例中,凝胶可以设置在管中,并且可以设计成持续指定数量的治疗(例如,约20个完整治疗)。 In embodiments, the gel can be provided in a tube and can be designed to last for a specified number of treatments (eg, about 20 full treatments). the
在实施例中,用设备100进行的皮肤治疗可以结合任何其他治疗方法,例如,光或超声传送,凝胶、乳膏、外用制剂等的应用。
In embodiments, skin treatment with
在实施例中,用设备100进行的皮肤治疗可以包括振动模块170,该振动模块被布置为使设备110振动以影响治疗效率。例如,可以布置振动,以帮助扩散以及使到所治疗的皮肤的热供应均匀化、扩散涂到皮肤上的流体、改进温度或运动测量、或指示一定的温度或运动阀值给使用者。例如,虽然设备100可停止超过一定阀值的加热,设备100也可通过振动指示接近这些阀值。例如,可以指导使用者施加治疗凝胶到电极,然后推动触发器按钮/开关,并且然后在(例如)每治疗区域在(例如)每个循环运动4分钟内治疗皮肤。在4分钟(示例性时间段)结束时,使用者感觉温和的振动且RF发射停止。然后,对于任何和所有治疗区域可以重复该程序。
In an embodiment, skin treatment with the
图6A和图6B分别是根据本实用新型的一些实施例示出皮肤治疗方法200的高水平示意性流程图的前部分和后部分。
Figures 6A and 6B are front and back sections, respectively, of a high-level schematic flowchart illustrating a
方法200可包括:根据指定传输方案经由电极将RF能量传送到皮肤(阶段210),和根据指定安全方案控制RF能量传送(阶段240)。
在实施例中,方法200包括:设计传输方案,以使在电极的子组下面的RF能量传送最大化(阶段212);和控制相对电极极性,以使所传送的RF能量集中到指定皮肤体积(阶段215),例如,线性地布置电极(阶段214),以及将除了一对或两对电极以外的所有电极指定为交替极性(阶段216)。传输方案可以设计成将所传送的RF能量集中到在一对或两对具有相同极性的相邻电极下面的指定皮肤体积。方法200进一步包括使皮肤的表面保持低于指定温度阀值(阶段218)。
In an embodiment,
在实施例中,方法200包括:测量在电极附近的皮肤温度(阶段220);测量电极的运动(阶段230);以及设计安全方案,以防止指定皮肤表面区域过热(阶段242)和由不熟练使用者进行的RF能量传送(阶段244)。安全方案可包括:在温度测量结果高于规定阀值时,停止RF能量传送(阶段246);和/或在比指定持续时间更长的时间段内缺乏运动时,停止RF能量传送(阶段248)。
In an embodiment,
在实施例中,方法200进一步包括:指示测得的温度接近指定阀值(阶段256);和/或指示缺少运动的时间段接近指定持续时间(阶段258)。
In an embodiment,
在实施例中,方法200进一步包括将温度敏感流体分配到皮肤上(阶段222)。温度敏感流体可指示皮肤表面温度,以防止表面过热。方法200可进一步包括使用或分配任何流体、凝胶、乳膏或外用制剂,以加强皮肤治疗。
In an embodiment,
在下面呈现了示范性临床数据。基于由FDA批准的PRE IDE协议,在临床研究中对根据本公开的一些实施例的皮肤治疗设备的实施例的安全性和效果进行了评价。对正在治疗的六(6)个身体部位分类执行了每受验者六(6)次治疗和一个随访,其中正在治疗的六个身体部位分类是: 腹部、大腿、手臂、臀部、鞍囊(saddle bag)和肩部(décolleté)。为了评价治疗效果,向两位无干医生介绍了治疗前后的照片用于不知情评价。为本研究总共招募了30名受验者。检测或报告无不良副作用。经报告参与本次研究的所有30名患者在治疗过程中无疼痛。由两个经过不知情认证的皮肤科医生执行数字图像的治疗前后的图像分析。分析表明绝大多数患者(根据第一审查者在最后随访为83.6%改善,和根据第二审查者为96.7%改善)的改善(根据菲氏量表(Fitzpatrick scale)至少1分的降级)。所发现的得分差异在统计学上是重要的,同时比较基准得分(baseline score)和6次治疗(p<0.001)和两个审查者的最后随访(p<0.001)之后获得的分数,从而表明治疗效果。 Exemplary clinical data are presented below. The safety and efficacy of embodiments of skin treatment devices according to some embodiments of the present disclosure were evaluated in clinical studies based on the PRE IDE protocol approved by the FDA. Six (6) treatments and one follow-up visit per subject were performed for the six (6) body part categories being treated: abdomen, thigh, arm, buttocks, saddlebag ( saddle bag) and shoulders (décolleté). In order to evaluate the treatment effect, the photos before and after treatment were introduced to two untrained doctors for blind evaluation. A total of 30 subjects were recruited for this study. No adverse side effects were tested or reported. All 30 patients participating in this study reported pain-free during treatment. Pre- and post-treatment image analysis of the digital images was performed by two blinded certified dermatologists. The analysis indicated improvement (downgrade of at least 1 point on the Fitzpatrick scale) in the vast majority of patients (83.6% improvement at last follow-up by first reviewer and 96.7% improvement by second reviewer). The found score differences were statistically significant, comparing the baseline score with scores obtained after 6 treatments (p<0.001) and the last follow-up visit by two reviewers (p<0.001), thus indicating treatment effect. the
在上述描述中,实施例是本实用新型的实例或实施。“一个实施例”、“实施例”或“一些实施例”的各种出现并不一定全部是指相同的实施例。 In the above description, an embodiment is an example, or implementation, of the invention. The various appearances of "one embodiment," "an embodiment" or "some embodiments" are not necessarily all referring to the same embodiments. the
虽然本实用新型的各种特征已经在单一实施例的背景下进行了描述,这些特征也可以单独地或以任何合适组合的方式提供。相反,虽然本实用新型可以为了清楚起见在分开的实施例中描述,但是本实用新型也可以在单一实施例中实施。 Although various features of the invention have been described in the context of a single embodiment, these features may also be provided separately or in any suitable combination. Conversely, although the invention may be described in separate embodiments for clarity, the invention may also be implemented in a single embodiment. the
本实用新型的实施例可包括来自上面公开的不同实施例的特征,并且实施例可包括来自上面公开的其他实施例的元素。在具体实施例背景下的本实用新型的元素的公开不被视为限制其单独在具体实施例中使用。 Embodiments of the invention may include features from different embodiments disclosed above, and embodiments may include elements from other embodiments disclosed above. Disclosure of elements of the invention in the context of a particular embodiment is not to be construed as limiting its use in that particular embodiment alone. the
此外,应当理解的是,本实用新型能够以各种方式来执行或实践,并且本实用新型能够在除了在上述描述中列出的那些实施例以外的实施例中实施。 Furthermore, it should be understood that the invention can be carried out or practiced in various ways and that the invention can be implemented in embodiments other than those set forth in the above description. the
本实用新型并不限于这些图或相应的描述。例如,流程不需要经过每个所示的框或状态、或完全地以示出或描述的相同顺序进行。 The invention is not limited to these figures or the corresponding description. For example, flow need not go through each illustrated box or state, or in exactly the same order as illustrated or described. the
本文所用的技术和科学术语的含义是本实用新型所属的技术领域的普通技术人员通常理解的含义,除非另有限定。 The meanings of the technical and scientific terms used herein are the meanings commonly understood by those of ordinary skill in the technical field to which the present invention belongs, unless otherwise defined. the
虽然已经就有限数量的实施例对本实用新型进行了描述,这些不应该理解为对本实用新型的范围的限制,而是作为一些优选实施例的范例。其他可能的变化、修改和应用也落入本实用新型的范围内。因此,本实用新型的范围不应该由已经所描述的内容限制,而是由所附的权利要求及其合法等同物限制。 While the invention has been described in terms of a limited number of embodiments, these should not be construed as limitations on the scope of the invention, but rather as exemplifications of some preferred embodiments. Other possible changes, modifications and applications also fall within the scope of the present invention. Accordingly, the scope of the present invention should not be limited by what has been described, but by the appended claims and their legal equivalents. the
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| CN106236250A (en) * | 2016-09-09 | 2016-12-21 | 深圳半岛医疗有限公司 | The bipolar radio frequency therapy equipment of the scalable treatment degree of depth |
| CN106413616A (en) * | 2014-06-04 | 2017-02-15 | 皇家飞利浦有限公司 | Centrosymmetric radio frequency electrode configuration for skin treatment |
| CN107297022A (en) * | 2017-06-20 | 2017-10-27 | 深圳市博昊电子有限公司 | A kind of electric region constructing system of heteropole, method and the electric region bridge system of heteropole |
| CN108778408A (en) * | 2015-11-06 | 2018-11-09 | Seb公司 | Include for measuring measuring device that product is not present, equipment and correlation method for being applied to product to be allocated by ionotherapy on user's skin |
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| CN117647692A (en) * | 2022-12-30 | 2024-03-05 | 江苏海莱新创医疗科技有限公司 | Tumor electric field treatment system, tumor treatment equipment and electrode slice fault detection method |
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| CN106413616A (en) * | 2014-06-04 | 2017-02-15 | 皇家飞利浦有限公司 | Centrosymmetric radio frequency electrode configuration for skin treatment |
| CN108778408A (en) * | 2015-11-06 | 2018-11-09 | Seb公司 | Include for measuring measuring device that product is not present, equipment and correlation method for being applied to product to be allocated by ionotherapy on user's skin |
| CN108778408B (en) * | 2015-11-06 | 2022-03-29 | Seb公司 | Device for applying a product to be dispensed to the skin of a user by iontophoresis, comprising measuring means for measuring the absence of a product, and corresponding method |
| CN106236250A (en) * | 2016-09-09 | 2016-12-21 | 深圳半岛医疗有限公司 | The bipolar radio frequency therapy equipment of the scalable treatment degree of depth |
| CN107297022A (en) * | 2017-06-20 | 2017-10-27 | 深圳市博昊电子有限公司 | A kind of electric region constructing system of heteropole, method and the electric region bridge system of heteropole |
| CN111796613A (en) * | 2020-06-30 | 2020-10-20 | 深圳半岛医疗有限公司 | Control method of radio frequency fat reduction device, radio frequency fat reduction device and readable storage medium |
| CN113350153A (en) * | 2020-07-17 | 2021-09-07 | 芙颜珂有限公司 | Skin care device and method of use |
| CN114428527A (en) * | 2022-01-26 | 2022-05-03 | 云南贝泰妮生物科技集团股份有限公司 | Radio frequency beauty instrument temperature control system based on ultrasonic echo |
| CN114534105A (en) * | 2022-03-16 | 2022-05-27 | 深圳市宗匠科技有限公司 | Radio frequency beauty instrument and radio frequency output control method thereof |
| CN117647692A (en) * | 2022-12-30 | 2024-03-05 | 江苏海莱新创医疗科技有限公司 | Tumor electric field treatment system, tumor treatment equipment and electrode slice fault detection method |
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