CN1674837A - 用于处理皮肤和皮下情况的方法和设备 - Google Patents

用于处理皮肤和皮下情况的方法和设备 Download PDF

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CN1674837A
CN1674837A CNA038198444A CN03819844A CN1674837A CN 1674837 A CN1674837 A CN 1674837A CN A038198444 A CNA038198444 A CN A038198444A CN 03819844 A CN03819844 A CN 03819844A CN 1674837 A CN1674837 A CN 1674837A
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CN1329008C (zh
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G·B·阿尔特舒勒
I·亚罗斯拉夫斯基
A·贝利科夫
K·普里克霍科
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Palomar Medical Technologies LLC
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Abstract

一种用于处理一定深度的区域中的组织同时保护非靶组织方法和设备，即，通过循环施加冷却到病人的皮肤，最好到该区域，以及在施加冷却期间和/或以后通过施加辐射到该区域以上的病人的皮肤来选择性地加热组织。冷却和辐射中的至少一个可以通过在病人的皮肤上相继通过连续输出的涂敷器来施加。通过施加机械、声或者电刺激到该区域来增强处理。

Description

用于处理皮肤和皮下情况的方法和设备
相关申请的交叉参考
本发明要求2002年6月19日提交的G.Altshuler等的题为“Method and Apparatus for Subdermal Heating”共同未决的美国临时专利申请序列号为No.60/389871的优先权，其通过参考整个包括在此。
技术领域
本发明涉及用于组织的光热处理的方法和设备，更具体的，涉及用于处理皮肤和皮下一定深度的情况的方法和设备。
背景技术
能够在组织的选择的区域中升高和/或降低温度来用于各种治疗和美容目的的优点已经知道了一段时间。例如，加热的垫或者板，或者各种形式的电磁辐射，包括可见、红外和微波辐射，电和超声先前已经用于加热皮下肌肉、韧带、骨骼等，以例如增加血流，以另外促进各种损伤或者其它损害的治愈，以及用于各种治疗目的，诸如冻伤或者高热症处理，贫血循环、物理治疗、胶原蛋白的刺激、脂肪团的处理、肾上腺素的刺激、伤口愈合、牛皮癣处理、身体整形、非介入皱纹去除等的处理。组织的加热也用作用于去除癌或者其它不需要的生长物、传染病毒等的潜在处理。加热可以应用在小的局部区域上，较大的区域上，例如手或者脚，或者组织的较大区域上，包括整个身体。
由于上述的大多数技术包括通过病人的皮肤表面将能量施加到一定深度的组织，所以通常在病人的皮肤表面处或者附近出现峰值温度，且有时随着深度极大地降低。此外，虽然在过去已经使用微波或者超声和其它声辐射，这样的辐射具有有限的使用，因为它们可能是潜在的诱导有机体突变的物质，可能潜在地另外导致细胞或者全身损害，尤其是微波，以及尤其是声源是相对昂贵的。它们对于大面积处理也可能是不实际的。
虽然光学和近红外(NIR)辐射(此后共同地称为“光辐射”)通常既不太昂贵，又是非诱导有机体突变的物质，比微波辐射安全，但是使用光辐射迄今还没有被认为是适合于大多数的应用，包括一定深度的组织的加热，这里使用的术语“一定深度的组织”意味着在真皮和皮下组织或者皮下区域的边界区域的组织，这些组织中的一些可能在较低的真皮中，大多数在深于1mm的深度，以及在该边界区域以下到达到大约50mm的深度的组织。为什么不认为该辐射是合适的辐射的理由在于，因为这样的辐射在组织的表面层中既是高度散射的，又是高度吸收的，使得这样的辐射的相当大的部分不能到达一定深度的组织区域，以引起其的加热。关于能量损耗，由于散射和吸收，必须施加相当大的光(包括NIR)能量，以便足够的这样的能量到达一定深度的组织的区域，以具有需要的效果。然而，这样的高能量会引起对组织的表面层的损害，以及对病人的痛苦/不适，使得难以在一定深度的组织区域中实现需要的光热处理。由于这些原因，迄今，光辐射对于一定深度的组织的治疗和美容处理最多具有有限的价值。
虽然已证明单独对一定深度的组织加热或者冷却对于很多处理是有用的，但是加热和冷却的组合的间隙地应用到皮肤表面(已知为对比治疗)也是已知的，且被建议用于皮肤改进、痛苦减轻、炎症减少和损伤治愈。特别重要的是，应用这些技术来降低皮下脂肪堆积和处理脂肪团(女性脂肪代谢障碍(gynoid lipodystrophy))。然而，使用冷却或者加热，单独的或者组合的用于处理一定深度的情况，例如用于皮肤改进、脂肪团改进、脂肪减少和处理其它情况受到身体的痛苦/不适的容忍度的限制，以及处理的器官和需要保持完整的邻近组织，尤其是皮肤的损害限制的限制。
因此，需要改进的方法和设备来用于一定深度的组织区域的光热处理，尤其是用于深的真皮和组织的皮下区域的处理，该处理提供改进的处理结果，同时减少病人的痛苦和不适，且防止邻近和其它非处理组织的损害。
发明内容
根据以上情况，本发明提供了一种方法和设备，用于处理病人的身体的至少一定深度的选择的靶区域，如前面已经定义的该术语，同时这样保护非靶组织，即，通过利用合适的机构来将病人的皮肤表面冷却到正常体温以下的温度持续选定的时间；在冷却以前、期间和/或以后利用合适的机构来选择性地施加辐射到所述区域以上的病人的皮肤；以及重复冷却和施加辐射持续选定的循环数目，病人的皮肤被冷却到的温度和冷却的持续时间足够至少在循环的冷却部分期间将处理区域冷却到正常体温以下的选定的温度。冷却持续时间应该至少为大约10秒，通常在近似10秒和20分钟之间。在冷却以后施加辐射的地方，辐射可以施加近似1秒到4分钟。冷却可以连续进行，而辐射在冷却期间的间隔施加。当选定的区域是皮下脂肪时，选定的温度应该足够低，以导致脂肪的至少一部分的至少选择的相变。在这样的情况下，辐射应该具有足够的功率和持续时间，以及具有合适的波长来加热处理区域到至少脂肪细胞的相被改变的温度。或者，辐射可以具有足够的功率和持续时间，以及具有合适的波长来加热处理区域到在该区域中的细胞的生物物理和生物化学特性中的至少一个改变的温度。或者，辐射应该具有足够的功率和持续时间，以及具有合适的波长来加热处理区域之上的组织来保护该组织，但是不极大地加热处理区域。对于另一个实施例，处理包括循环冷却和加热处理区域，冷却以后施加辐射，且辐射可以具有足够的功率和持续时间，以及具有合适的波长将区域加热到合适的温度以实施处理。对于一些实施例，检测病人的选定情况，且用于控制操作的至少一部分。也可以在操作中的至少一个以前、期间和/或以后利用选定区域的刺激，这样的刺激通常为机械、声和电中的至少一种。处理循环的周期和/或相位可以与病人的亚生物钟相关。
对于一些实施例，辐射来自连续的波源，冷却也由大致连续的操作源进行。对于这些实施例，冷却和辐射应用的每一个通过以选定的速率将输出合适源的涂敷器通过病人的覆盖处理区域的皮肤来进行。相同的涂敷器可以用于进行这些实施例的冷却和辐射应用，涂敷器可以在相同的通过或者分开的通过期间进行两个操作。
根据本发明的另一个方面，辐射选择性地输送到选定的区域以上的病人的身体，以加热该区域；选定区域以上的病人的组织同时冷却到选定区域以下的温度；以及在该区域的加热以前和/或以后，该区域冷却到正常体温以下的温度。
根据本发明的还有一个方面，通过经由提供大致连续冷却/辐射输出的至少一个涂敷器在选定的区域之上的病人的皮肤的表面循环地施加辐射和冷却来进行处理，该涂敷器在每个冷却/辐射循环在病人的皮肤上通过该区域多次。
本发明的其它优点、新颖性特征和目的将从下面的结合附图的本发明的详细描述变得明白，这些附图是示意性的，其不是按比例画的。在附图中，在各个附图中显示的每个相同的或者大致类似的部件由单个数字或者标记表示。为了清楚起见，在每个附图中不是每个部件都标记，也不是本发明的每个实施例的每个部件都显示，其中，视图不是必须使本领域中的普通技术人员理解本发明。
附图说明
参考附图，通过举例来描述本发明的非限制性的实施例，其中：
图1是示出了在表面冷却开始以后在各个时间的皮肤和皮下组织的温度/深度曲线的图表；
图2示出了对于各种深度的人体的温度作为冷却时间的函数的图表；
图3是示出了病人的不适的开始时间和病人的痛苦的开始时间作为皮肤表面温度的函数的图表；
图4是适用于实践本发明的教导的设备的示意图；
图5a-5d是示出了在保护模式下对于连续冷却/加热循环的冷却温度、加热温度、在皮肤的较上层的温度和一定深度的靶温度的图表；
图6a-6d是示出了在治疗模式下对于连续冷却/加热循环的冷却温度、加热温度、在皮肤的较上层的温度和一定深度的靶温度的图表；
图7是示出了在脂肪中的光投射比的滞后的图表；
图8a是适合用于实现本发明的教导的光学头的剖面侧视图；
图8b是在图8a中显示的光学头的一部分的放大的剖面侧视图；
图9是示出了在多次扫描模式下使用由图8中显示的涂敷器进行的非选择性的加热时在皮肤的不同深度处的温度动态的图表；以及
图10是示出了在多次扫描模式下使用由图8中显示的涂敷器进行的非选择性的加热时在皮肤的不同深度处的血管中的温度动态的图表。
具体实施方式
本发明可以有用的申请包括各种病理和美容情况的处理，尤其是皮肤再生、皱纹去除、皮肤绷紧和消皱、气味产物的去除、毛发生长控制、痤疮处理、脂肪团和皮下脂肪处理、物理治疗、肌肉和骨骼处理，包括脊髓问题的处理和诸如腕管综合症(CTS)、腱炎和粘液囊炎、纤维肌痛症、淋巴水肿和癌症治疗之类的累积性创伤疾病(CTD)的处理。
施加到组织的热能，加热或者冷却，还可以用于例如物理治疗处理中，使得增强或者加速伤口愈合或者减轻痛苦。有益的效果包括减少关节僵硬、增加诸如腱和伤疤组织之类的胶原结构的关节可延长性、减轻痛苦、改变血流或者减少肌肉痉挛和增加肌肉张性。作为另一个例子，大的蛋白质分子具有高的吸收系数，富含蛋白质的胶原组织的加热有助于治愈。使用本发明可以处理多种类的情况，例如，但不限于，变形的腱、腱鞘炎、韧带撕裂、腱炎、粘液囊炎、关节囊撕裂或者肌肉撕裂。热处理可以对诸如皮脂腺、汗腺和毛囊之类的高度新陈代谢的器官有效。在冷却或者加热期间，可以激活或者失活组织中的其它过程。机械或者电刺激，诸如按摩，也可以结合冷却或者加热来使用，以实现比通过任何一个单独的操作可以获得益处更大的益处。正压和负压也可以施加到处理区域之上的皮肤表面，以促进处理。
在某些实施例中，本发明可以用于非介入或者非破坏性局部脂肪堆积的减少。例如，本发明可以用于加热脂肪或者脂肪细胞超过它们的损坏温度，引起细胞损坏和/或坏死。或者，处理的细胞可以经历凋亡，导致细胞死亡。然后死细胞可以被去除或者例如通过身体的噬菌细胞或者淋巴系统再吸收到身体。脂肪的减少还可以通过加热脂肪或者脂肪细胞到升高的温度，但是低于损坏温度来实现。例如，脂肪细胞可以被加热到大约41℃和大约45℃之间的温度。在这些情况下，将热施加到皮下脂肪可以激活脂肪酶或者在皮下脂肪层中发现的包含在脂肪组织中的新陈代谢的脂质，或者血流可以增加到加热的区域。另外，“脂解”或者分解身体中的脂肪的过程可以通过对温度敏感的酶调节，诸如HSL(“对激素敏感的脂肪酶”)。这样，升高脂肪细胞的温度可以增加脂解速率，这样有助于减少被处理的区域中的皮下脂肪。该温度可以低于脉管/淋巴损坏的温度，所以可以容易地从处理区域去除损坏的脂肪细胞和脂肪酸。另外，本发明的应用可以结合其它脂肪减少技术使用，诸如药物治疗、锻炼或者肾上腺素刺激。
本发明还包括将脂肪组织冷却到低于正常体温的温度，最好低于脂肪细胞的脂质内容物的至少一些部分相变温度，该温度充分高于含水组织的冰冻温度，优先或者最好后面是加热脂肪到低于其损坏域值的温度。当甘油三酸酯(其构成人的脂肪组织中的脂质的最大部分)的温度从正常体温变化到较低或者较高温度时，它们经历一系列的相变。尤其是，可能存在一些晶体形式。这些形式为(以稳定性增加的顺序)：α、β’和β。较后的晶体在尺寸上也大很多(像十二微米长的针)。晶体的形成可以是由于脂肪细胞机能障碍和由细胞结构上的机械应力和/或细胞新陈代谢的破坏产生的收缩。β晶体形成可能是脂肪细胞处理的初级机制。当甘油三酸酯从正常体温冷却时，产生α晶体的形成。为了产生更稳定的形式，β’第一和β第二，需要反向加热结晶的甘油三酸酯。进一步的加热导致所有晶体形式完全熔化。
因此，建议下面的过程来开始脂肪细胞中的β晶体的形成。首先，脂肪组织冷却到低于正常温度Tα(在0到37℃之间的范围)。这导致α晶体形成。然后，组织加热返回到温度Tβ＞Tα，但是低于37℃，引起形成β’和β晶体。最后，组织可以被加热到甚至更高的温度，以便熔化晶体，且该过程可以重复选定数量的周期。期望的最终结果是脂肪组织体积的萎缩和减小。该过程发生在0-37的所有温度范围，但是对于较低的Tα，该过程更加有效。通过从额外的细胞空间去除蛋白质，皮下组织中的淋巴系统的热激活也可以用于处理脂肪团。
冷却板(剂或者装置)施加到皮肤表面引起皮肤和皮下区域或者皮下组织的温度逐渐下降，如由图1所示。在图1中，曲线(1)为将冷却板施加到皮肤表面1分钟以后，曲线(2)为将冷却板施加到皮肤表面5分钟以后，曲线(3)为将冷却板施加到皮肤表面10分钟以后，以及曲线(4)为将冷却板施加到皮肤表面30分钟以后。皮肤/脂肪或者真皮/皮下边界的深度，在图1中显示为3mm，将根据许多因素而变化，包括病人和处理的病人的身体的部分。冷却速率和最终温度依赖于靶的深度，皮肤表面的温度。图2示出了由恒定的表面温度0℃产生的在2.5mm深度处的真皮-皮下组织个在7.5mm深度处的皮下脂肪的计算的温度动态。皮肤中的靶的充分冷却可以在10秒和300秒之间的时间范围内实现。在皮下脂肪中的更深的靶需要在2分钟和30分钟之间范围内的冷却时间。通过同时结合到皮肤压力或者声波或者通过冷却的皮肤的强烈按摩可以缩短冷却时间。通过细胞间水的强制对流，声波或者机械按摩可以增加皮肤和皮下脂肪的热传导性。
根据表面温度和施加的持续时间，在脂肪和其它组织中可以开始许多过程，包括，但不限于：
脂质的相变；
脂肪细胞的调节功能的变化。尤其是，较低的温度可以抑制Alpha2受体的活性，其抑制腺苷酸环代酶和循环AMP通过Gi蛋白质，这样降低了脂解速率。这可以导致冷暴露以后脂肪细胞的长期萎缩。
增加细胞内水的离子浓度。这样的增加通过在脂肪结晶过程中部分结合自由水来产生。已经利用光谱方法证明了水转变为结合状态。结果，在剩余自由水中的离子浓度增加。一旦离子浓度超过临界水平，可能发生对细胞的生命机制的不可逆转的损坏；
组织中的水的结晶；
引起凋亡；
组织坏死；
刺激生热作用；
改造脉管和淋巴管；
毛囊、皮脂腺和汗腺的暂时或者永久机能障碍。
在实际使用中，通过不合意，以及随后的痛苦感觉的开始来限制冷暴露的时间。图3示出了这些开始时间对皮肤表面温度的依赖性。结果，实际施加时间可能对于获得需要的治疗效果是不充分。
热循环，包括冷却和加热阶段，可以用于消除靶区域外部的痛苦/不适和不需要的组织损坏。应该强调，尽管前面已经提出了在热和冷之间交替皮肤表面温度的方法和装置，但是组织的热惰性阻碍了热前缘从皮肤表面到需要的处理深度(或者反过来)的快速传播。
因此，本发明使用深度穿透电磁或者声辐射，以产生组织内的分布的热源。这允许充分地增加处理时间和实现可接受的治疗效果，同时维持完全非介入的过程和病人的舒适性。
热循环的有益效果不限于处理脂肪组织。热循环启动许多在分子、细胞、组织和器官级别的生物物理和生物化学响应，包括(但不限于)：
细胞膜的渗透性，从而膜内传输和隔室内和隔室间隙之间的交换的调节；
在靶(例如，恶性)细胞中感应热机应力，通过坏死或者凋亡导致细胞死亡；
脉管壁的弹性和渗透性的变化；
血液流变的变化；
组织再生的刺激，包括在皮肤和皮下组织中新胶原质的产生；
在间质液中的毒素结构的变化，使得它们能够易于通过淋巴系统去除。
结果，热循环可以用于处理宽范围的情况，包括皮肤、皮下脂肪、结缔组织、血液和淋巴脉管系统、肌肉、骨骼和其它内部器官。
用于实现该技术概念的设备由图4显示。该实现是典型的，且由本领域中的普通技术人员可以容易地为具体的应用得到合适的结构。冷却单元可以是热电元件，具有冷却剂的盒，冷气体(或者液体)的流，或者本领域中已知的其它冷却单元。相变材料也可以用于冷却。优选的，在冷却阶段期间，皮肤表面温度应该维持在0℃和25℃之间的范围内。最好加热阶段的组织温度在25℃和45℃之间的范围内。在本发明的一个实施例中，光辐射用在循环的加热阶段。在该实施例中，能源可以是激光器、LED、灯(放电、卤素或者其它)，或者其组合或阵列。源的光谱成分可以是窄带或者宽带，波长范围窄400nm和2000nm之间。光谱过滤可以用于进一步修改束的光谱成分，以便获得最佳穿透。用于具体应用的波长依赖于靶组织，组织的深度和其它因素。光源最好以连续波(CW)的模式工作，使得在皮肤表面处的优选辐照在0.1和100W/cm2的范围内。热循环以这样的方式组织，使得最大化处理功效。通常，冷却阶段的持续时间可以在10秒和30分钟之间，而加热阶段的持续时间可以在1秒和4分钟之间。图4的设备还包括用于能源的电源、合适的控制单元、选择传感器，其功能将在后面讨论，以及通常用于这样的设备中的其它部件。
本发明可以以两种不同的模式(图5和6可见)实现：在保护模式下，热循环用于保护邻近(通常，上部)组织防止不希望的损坏；而在治疗模式下，热循环大致用作处理形式。
本发明可以在至少两种不同的模式下实现(图5和6所示)。在图5的保护模式下，开始施加的冷却迅速降低皮肤表面、靶区域和其间所有组织的温度。在病人经历痛苦或者不适以前，以及在靶区域以外出现热损坏以前，开始加热阶段。来自能源的辐射足够升高皮肤表面，以及下到处理区域以上的深度的温度达到不适或者损坏温度以上的温度，但是对一定深度处的处理区域具有很少的作用。这导致处理区域的温度随着连续的冷却循环而继续稍微下降。因此，热循环的该模式用于保护邻近(通常，上部)组织防止不期望的损坏。在图6所示的治疗模式中，热循环大致用作处理形式。这里，冷却和辐射参数选择为使得在加热循环期间，在表面和处理区域处的温度上升到正常体温以上，这样，处理区域在冷治疗和热治疗之间循环。虽然在图6中，靶区域在每个循环的加热部分期间被加热到正常体温以上，但这不是本发明的限制，且循环加热靶区域到低于正常体温以下的选定的温度对于一些情况也具有治疗效果。循环还可以这样来实现，即，通过加热靶区域到足够引起高温的温度，例如42到47℃，同时通过或者不通过冷却来保护上面的组织，然后减少或者去除辐射或者增加冷却来冷却处理区域到正常体温以下，这是周期地进行的。
当光辐射用作深度穿透能量时，热循环提供另一个优点。尤其是，已经证明，通过光学测量，当新鲜的人类脂肪组织被加热时光透射比增加的速度超过当相同的组织冷却时光透射比下降的速度(图7)。有这样的迹象，即，通过在25和30℃之间的相对窄的温度范围内的热循环引起脂肪组织中的积累的不可逆转的结构变化。因此，光辐射的穿透深度(以及加热阶段的效率)可以通过多次循环来增加。
在一些实施例中，设备的涂敷器(手柄)可以实现为固定器具，其在开始热循环以前放置在处理区域上。
在其它实施例中，手柄可以沿着皮肤表面手动或者机械地扫描(图8可见)。热循环可以与扫描同时进行。或者，热循环可以这样实现，即，通过在冷却阶段进行至少一个(最好几个)通过，随后是在加热阶段的至少一个(最好几个)通过，以及重复该循环，直到实现需要的治疗效果。参考图8a，显示了一种典型的扫描手柄，其包括把手1和涂敷器2。参考图8b，涂敷器2包括安装件3、反射器冷却风扇4、可选的压力或者声产生器、振荡器或者按摩器具5、反射器6、辐射源(对于显示的实施例为弧形或者卤素灯)7、冷却板8、起机械速度传感器作用的可选的轮9、冷却剂10和滤光器11。
图8的设备可以用于尤其是多次扫描模式。该多次扫描模式导致在不同深度的不均匀的温度循环。图9示出了对于多次扫描操作的在表皮/真皮接合处(0.1mm深)、真皮/下皮接合处(2.5mm深)和皮下脂肪(7.5mm深)处的温度作为时间的函数。在下面的条件下进行计算：波长800-1800nm(卤素灯的过滤的光谱)，功率密度80W/cm2，横过扫描方向的光束宽度为1cm，扫描速度为10cm/s，扫描长度为50cm，与皮肤接触的冷蓝宝石窗的温度为-10℃。对于扫描模式，接触板的温度可以是极大地低于皮肤冷冻温度，在快速扫描速度(大约10cm/s)，可能低到-50℃，而没有冻伤的危险。图9示出了热振荡的幅度随着皮肤中的深度而下降。然而，对于深靶的温度稳定的时间可能是长的：0.1mm-100秒或者10次扫描，2.5mm-5分钟或者30次扫描，7.5mm-15分钟或者90次扫描。
图10示出了在第一丛(0.015mm直径，0.1mm深)、第二丛(0.2mm直径，2.5mm深)和皮下脂肪(0.1mm直径，7.5mm深)的血管的温度作为多次扫描操作的时间的函数。在下面的条件下进行计算：波长400-1800nm(卤素灯的过滤的光谱)，功率密度65W/cm2，横过扫描方向的光束宽度为1cm，扫描速度为10cm/s，扫描长度为50cm，与皮肤接触的冷蓝宝石窗的温度为-10℃。图10示出了在血管中的热振荡的幅度在皮肤中相当大，在皮下脂肪中可以忽略。在第二丛中的脉管的大温度振荡(达到10℃)对于在深的真皮和真皮/下皮接合处的各种条件的处理，以及对于脂肪团的美容外观的改进是有效的。由于在皮下脂肪中的脉管温度连续上升，该处理对于增加脂解速度是有效的。
当能源是连续波(CW)或者其它长持续时间源时，用于各种实施例的设备或者装置可以在病人的皮肤的表面上滑动或者扫描，以位于连续的处理区域上，对于每个这样的区域的停留时间，从而处理持续时间为装置移动的速度的函数。在单次处理期间，装置可以在每个处理区域上移动多次。由于装置通常还包括皮肤冷却机构，当装置通过每个区域之上时，对每个区域实现同时加热和冷却。装置还可以包括能源下面的装置的一部分前面的冷却机构，以预冷却处理区域之上的皮肤(例如，颁发的美国专利No.6273884和6511475可见，其通过参考在此引入)。操作的滑动模式的功率密度Ps为：
Ps＝P0Tv/d，
其中，P0是以固定模式被处理的器官/区域的功率密度
V是滑动速度，
d是扫描方向上的斑点或者孔径的尺寸，
T是经过同一斑点的两个连续通过之间的间隔，
处理时间是
Ts＝T0Tv/d，
其中，T0是对于被处理的器官/区域的固定模式处理时间。为了使得多次通过为有益的，T应该小于一定深度的区域中被处理的组织的热松弛时间。然而，当在固定模式或者滑动模式下时，处理时间可以大于被处理的组织的热松弛时间。
实施例中的任何一个可以包括接触传感器，以确保好的光和热耦合，在滑动模式下工作的系统还可以包括一个或者多个移动传感器，以根据扫描速度控制辐射传送，冷却和其它功能，以提高系统的安全性以及其它原因。
除了将本发明的深度加热处理与深度冷却结合来增强脂肪、骨骼、肌肉等的处理以外，涂敷器还可以包括按摩器、振荡器或者其它机械刺激装置，超声或者其它声刺激器或者DC或者其它合适的电刺激源。已经发现，当组织温度从正常体温偏离(即，对于热的或者冷的组织)时，这样的机械或者电刺激更加有效。类似的，深度加热的效果可以通过按摩或者其它刺激来增强，因为热和冷通常更好地穿透压缩的皮肤和皮下组织。这样，深度加热和机械或者电刺激的组合可以提供比任何单独一种要好很多的结果。加热也可以通过用例如由AC/DC产生的电刺激或者由RF产生的额外加热来补充光加热来增强。施加到处理区域上面的皮肤上的张紧或者压力也可以增强处理效果和减少病人的不适/痛苦感。
虽然光辐射源已经用于优选的实施例，但是其它形式的电磁辐射，诸如微波或者射频辐射可以用于循环的加热阶段。或者，可以使用声能。除非另外指示，如这里使用的，术语辐射应该指从所有这样的源的输出。应该选择所利用的源的功率，以便维持优选范围内的靶组织的温度。
通过实现耐热方式，本发明的效力还可以进一步提高。在这样的模式下，温度偏离病人能够忍受的正常皮肤表面温度的幅度随着循环逐渐增加，允许处理温度，因而处理效果也逐渐随着循环增加。该模式允许进一步增加皮下组织的保护防止不期望的损坏。
还可以将热循环的周期和相位与病人的亚生物钟相关。这样的组合可以通过使用自然出现的皮肤和皮下组织中的生物化学活动的振荡来进一步优化处理结果。而且，热循环的临时结构可以偏离简单的谐振，且例如包括几个或者甚至无穷数量的谐波。
在某些实施例中，冷却器具可以实现为设置在处理区域上的层(膜、覆盖物)，且辐照涂敷器可以实现为在冷却器具的顶部上扫描的头部。由于辐照涂敷器的多次通过实现热循环。
本发明的一些实施例可以包括涂敷器和控制单元之间的反馈回路。该反馈回路可以包括单个或者多个传感器，记录设备和处理区域的状态。例如，当组织温度下降到某个域值以下时，热传感器可以用于开始循环的加热阶段，当温度超过另一个域值时，开始循环的冷却阶段。其它传感器类型包括，但不限于，扫描速度传感器、接触传感器、压力传感器、皮肤检测器和皮肤响应传感器。
在本发明的一些实施例中，另外的刺激器具可以集成到涂敷器(如图8b可见)。该器具的目的是优化组织结构和促进热循环。该器具可以是例如机械(编织、滚动或者拉动动作)或者真空(在处理区域中的负压/正压)。也可以利用其它形式的组织刺激，例如，超声或者其它声刺激，或者电刺激。
虽然这里描述和显示了本发明的几个实施例，但是本领域中的普通技术人员可以容易地设想多种其它装置和结构来用于进行这些功能和/或获得这些结果和/或这里描述的优点，这样的变化或者改变的每一个被认为是在本发明的范围内的。更具体的，本领域中的普通技术人员容易理解，这里描述的所有参数、尺寸、材料和形状意味着是典型的，且实际的参数、尺寸、材料和形状将依赖于使用本发明的教导的具体的应用。本领域中的普通技术人员可以认识到，或者能够使用不超过常规实验来确定这里描述的本发明的具体实施例的很多等价物。因此，可以理解，前述实施例只是通过例子来提出的，且在后附的权利要求书及其等价物的范围内，本发明可以除了具体描述的以外来另外实现。本发明涉及这里描述的每个单个的特征、系统、材料和/或方法。此外，两个或者多个这样的特征、系统、材料和/或方法的任何组合包括在本发明的范围内，如果这样的特征、系统、材料和/或方法不是相互矛盾的。在权利要求书中，所有过渡短语或者包含短语，诸如“包括”、“包含”、“携带”、“具有”、“含有”等要被理解为开放式的，即，意味着“包括但不限于”。只有过渡短语或者包含短语“由...组成”和“主要由...组成”被分别理解为封闭的或者半封闭的短语。

Claims (48)

1.一种用于处理病人的身体的至少一定深度的选定的靶区域，同时保护非靶组织的方法，其包括：
(a)将病人的皮肤表面冷却到正常体温以下的温度持续选定的时间；
(b)在步骤(a)以前、期间和以后中的至少一个选择性地施加辐射到所述区域以上的病人的皮肤；以及
(c)重复步骤(a)和(b)中的至少一个持续选定的循环数目，病人的皮肤表面被冷却到的温度和所述持续时间足够至少在循环的冷却部分期间将所述区域冷却到正常体温以下的选定的温度。
2.如权利要求1所述的方法，其特征在于，所述选定的持续时间至少大约10秒。
3.如权利要求2所述的方法，其特征在于，所述选定的持续时间在近似10秒和30分钟之间。
4.如权利要求1所述的方法，其特征在于，步骤(b)在步骤(a)以后进行，且具有从近似1秒到4分钟的持续时间。
5.如权利要求1所述的方法，其特征在于，步骤(a)连续进行，且步骤(b)在步骤(a)期间的间隔施加。
6.如权利要求1所述的方法，其特征在于，所述选定的区域是皮下脂肪，且所述选定的温度足够低，以导致所述脂肪的至少一部分的至少选择的相变。
7.如权利要求6所述的方法，其特征在于，所述辐射具有足够的功率和持续时间，以及具有合适的波长以将所述区域加热到至少脂肪细胞的相被改变的温度。
8.如权利要求1所述的方法，其特征在于，所述辐射具有足够的功率和持续时间，以及具有合适的波长将所述区域加热到在该选定的区域中的细胞的生物物理和生物化学特性中的至少一个被改变的温度。
9.如权利要求1所述的方法，其特征在于，所述辐射具有足够的功率和持续时间，以及具有合适的波长来加热所述选定的区域之上的组织来保护所述组织，但是不极大地加热所述区域。
10.如权利要求1所述的方法，其特征在于，所述处理包括循环冷却和加热所述区域，步骤(b)在步骤(a)以后进行，且所述辐射具有足够的功率和持续时间，以及具有合适的波长将所述区域加热到合适的温度以实施所述处理。
11.如权利要求1所述的方法，其特征在于，其包括在步骤(a)和步骤(b)中的至少一个期间检测病人的选定情况，以及在步骤(a)和步骤(b)中的至少一个期间利用所述检测步骤来控制。
12.如权利要求1所述的方法，其特征在于，其包括在步骤(a)和(b)中的至少一个以前、期间和以后中的至少一个期间刺激所述选定区域。
13.如权利要求12所述的方法，其特征在于，所述刺激为机械、声和电中的至少一种。
14.如权利要求1所述的方法，其特征在于，步骤(a)和(b)的循环的周期和相位中的至少一个与病人的亚生物钟相关。
15.如权利要求1所述的方法，其特征在于，所述辐射来自连续的波(CW)源，冷却也由大致连续的操作源进行，其中，步骤(a)通过以选定的速率将输出所述冷却源的涂敷器通过病人的覆盖所述选定的区域的皮肤来进行，而步骤(b)通过以选定的速率将输出所述辐射的涂敷器通过病人的覆盖所述选定的区域的皮肤来进行。
16.如权利要求15所述的方法，其特征在于，相同的涂敷器用于进行步骤(a)和(b)。
17.如权利要求16所述的方法，其特征在于，在涂敷器在病人的皮肤上相同的通过期间进行步骤(a)和(b)。
18.如权利要求15所述的方法，其特征在于，当由在病人的皮肤上通过的涂敷器来进行步骤(b)时，辐射功率相对于固定涂敷器需要的功率增加了因子Tv/d，其中，T是在相同的区域上通过之间的间隔，v是涂敷器运动的速度，而d是涂敷器孔径的尺寸。
19.如权利要求18所述的方法，其特征在于，涂敷器滑过病人的皮肤的处理时间也增加了因子Tv/d。
20.如权利要求18所述的方法，其特征在于，T小于在所述选定的区域中的组织的热松弛时间。
21.一种用于处理病人的身体的至少一定深度的选定的靶区域，同时保护非靶组织的设备，其包括：
(a)将病人的皮肤表面冷却到正常体温以下的温度持续选定的时间的机构；
(b)在病人的皮肤表面冷却以前、期间和以后中的至少一个选择性地施加辐射到所述区域以上的病人的皮肤的机构；以及
(c)控制引起用于冷却的机构和用于施加辐射的机构中的至少一个操作持续选定的循环数目，病人的皮肤表面被冷却到的温度和所述持续时间足够至少在循环的冷却部分期间将所述区域冷却到正常体温以下的选定的温度。
22.如权利要求21所述的设备，其特征在于，所述选定的持续时间至少大约10秒。
23.如权利要求22所述的设备，其特征在于，所述选定的持续时间在近似10秒和30分钟之间。
24.如权利要求21所述的设备，其特征在于，用于施加辐射的所述机构在用于冷却的所述机构以后操作，且具有从近似1秒到4分钟的持续时间。
25.如权利要求21所述的设备，其特征在于，用于冷却的所述机构连续操作，且用于施加辐射的所述机构在用于冷却的机构操作期间的间隔操作。
26.如权利要求21所述的设备，其特征在于，所述选定的区域是皮下脂肪，且其中所述选定的温度足够低，以导致所述脂肪的至少一部分的至少选择的相变。
27.如权利要求26所述的设备，其特征在于，所述辐射具有足够的功率和持续时间，以及具有合适的波长将所述区域加热到至少脂肪细胞的相被改变的温度。
28.如权利要求21所述的设备，其特征在于，所述辐射具有足够的功率和持续时间，以及具有合适的波长将所述区域加热到在所述选定的区域中的细胞的生物物理和生物化学特性中的至少一个被改变的温度。
29.如权利要求21所述的设备，其特征在于，所述辐射具有足够的功率和持续时间，以及具有合适的波长来加热所述选定的区域之上的组织来保护所述组织，但是不极大地加热所述区域。
30.如权利要求21所述的设备，其特征在于，所述处理包括循环冷却和加热所述区域，用于施加辐射的所述机构在用于冷却的所述机构以后操作，且所述辐射具有足够的功率和持续时间，以及具有合适的波长将所述区域加热到合适的温度以实施所述处理。
31.如权利要求21所述的设备，其特征在于，其包括所述机构中的至少一个的操作期间检测病人的选定情况的机构，以及所述控制利用从用于检测的所述机构的输出，以用于冷却的机构和用于施加辐射的机构中的至少一个。
32.如权利要求21所述的设备，其特征在于，其包括所述机构中的至少一个操作以前、期间和以后中的至少一个期间刺激所述选定区域的刺激器。
33.如权利要求32所述的设备，其特征在于，所述刺激器为机械、声和电刺激器中的至少一种。
34.如权利要求21所述的设备，其特征在于，用于施加辐射的所述机构包括连续的波(CW)源，用于冷却的所述机构也大致连续地操作，输出所述CW源的涂敷器以选定的速率通过病人的覆盖所述选定的区域的皮肤，用于所述冷却机构的涂敷器以选定的速率通过病人的覆盖所述选定的区域的皮肤。
35.如权利要求34所述的设备，其特征在于，相同的涂敷器用于所述冷却和所述辐射施加机构。
36.如权利要求35所述的设备，其特征在于，在涂敷器在病人的皮肤上相同的通过期间操作所述冷却和所述辐射施加机构。
37.如权利要求34所述的设备，其特征在于，当由涂敷器在病人的皮肤上通过来操作辐射施加机构时，辐射功率相对于固定涂敷器需要的功率增加了因子Tv/d，其中，T是在相同的区域上通过之间的间隔，v是涂敷器运动的速度，而d是涂敷器孔径的尺寸。
38.如权利要求37所述的设备，其特征在于，涂敷器滑过病人的皮肤的处理时间也增加了因子Tv/d。
39.如权利要求37所述的设备，其特征在于，T小于在所述选定的区域中的组织的热松弛时间。
40.一种用于处理病人的身体的至少一定深度的选定的区域，同时保护选定的区域之上的组织的方法，其包括：
(a)选择性地将辐射输送到所述选定的区域以上的病人的身体，以加热所述区域；
(b)同时冷却所述选定区域以上的病人的组织到选定区域以下的温度；以及
(c)在该区域的加热以前和以后中的至少一个，冷却所述区域到正常体温以下的温度，对于所述区域具有至少一个加热和冷却循环。
41.如权利要求40所述的方法，其特征在于，其包括：(d)施加机械、声和电刺激中的至少一种到所述区域。
42.一种用于处理病人的身体的至少一定深度的选定的区域的方法，它包括：
通过提供大致连续冷却/辐射输出的至少一个涂敷器循环地施加辐射和冷却到在选定的区域之上的病人的皮肤的表面，该涂敷器在每个冷却/辐射循环在病人的皮肤上通过该区域多次。
43.如权利要求42所述的方法，其特征在于，当单个涂敷器通过病人的皮肤时，其同时施加冷却和辐射。
44.如权利要求42所述的方法，其特征在于，在每个循环的各个冷却和辐射部分期间，单个涂敷器连续施加冷却和辐射，涂敷器在所述部分的至少一个部分多次通过病人的皮肤。
45.一种用于处理病人的身体的至少一定深度的选定的靶区域，同时保护非靶组织的方法，它包括：
(a)将病人的皮肤表面冷却到正常体温以下的温度持续选定的时间；
(b)在步骤(a)以后选择性地施加辐射到所述区域以上的病人的皮肤，所述辐射具有足够的功率和持续时间，以及具有合适的波长将所述区域加热到合适的温度，以结合步骤(a)实现所述处理；以及
(c)重复步骤(a)和(b)中的至少一个持续选定的循环数目，病人的皮肤表面被冷却到的温度和所述持续时间足够至少在循环的冷却部分期间将所述区域冷却到正常体温以下的选定的温度。
46.一种用于处理病人的身体的至少一定深度的选定的靶区域，同时保护非靶组织的方法，它包括：
(a)输出大致连续操作冷却源的涂敷器以选定的速率通过病人的覆盖所述选定的区域的皮肤，以冷却病人的皮肤表面到正常体温以下的温度持续选定的时间；
(b)输出来自大致连续波辐射源的辐射的涂敷器以选定的速率通过病人的覆盖所述选定的区域的皮肤，以在步骤(a)以前、期间和以后中的至少一个选择性地施加辐射到所述区域；
(c)重复步骤(a)和(b)中的至少一个持续选定的循环数目，病人的皮肤表面被冷却到的温度和所述持续时间足够至少在循环的冷却部分期间将所述区域冷却到正常体温以下的选定的温度。
47.如权利要求46所述的方法，其特征在于，相同的涂敷器用于进行步骤(a)和(b)。
48.如权利要求47所述的方法，其特征在于，在涂敷器在病人的皮肤上的相同通过期间进行步骤(a)和(b)。
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