CN101917944B - 监视诸如脂肪组织的冷却这种皮下富含脂质的细胞的冷却 - Google Patents

监视诸如脂肪组织的冷却这种皮下富含脂质的细胞的冷却 Download PDF

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CN101917944B
CN101917944B CN200880103822.5A CN200880103822A CN101917944B CN 101917944 B CN101917944 B CN 101917944B CN 200880103822 A CN200880103822 A CN 200880103822A CN 101917944 B CN101917944 B CN 101917944B
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J·N·罗森
C·A·辛顿
K·S·斯宾格
M·E·丽芙森
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Zeltiq Aesthetics Inc
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Abstract

描述了一种在将热量从皮下富含脂质的细胞中去除过程中监视、控制和/或探测事件的系统和方法。在许多实例中，系统探测到与对象皮肤接触的治疗装置处温度的增加，确定温度的增加是与治疗事件有关，以及基于所确定的内容而执行动作。在许多实例中，系统关闭治疗装置，警告操作者或减少冷却响应所确定的治疗事件。

Description

监视诸如脂肪组织的冷却这种皮下富含脂质的细胞的冷却
参照共同拥有的申请的结合
下列共同转让的美国专利申请在此通过参照其整体而得以结合：
发明名称为“METHOD OF ENHANCED REMOVAL OF HEAT FROMSUBCUTANOUS LIPID-RICH CELLS AND TREATMENT APPARATUSHAVING AN ACTUATOR”、2007年5月18日申请的、申请号为No.11/750953的美国专利；
发明名称为“FREEZING METHOD FOR CONTROLLED REMOVAL OFFATTY TISSUE BY LIPOSUCTION”的美国专利No.6032675；
发明名称为“CRYOPROTECTANT FOR USE WITH A TREATMENTDEVICE FOR IMPROVED COOLING OF SUBCUTANEOUS LIPID-RICHCELLS”、公开号为No.2007/0255362的美国专利；
发明名称为“COOLING DEVICE FOR REMOVING HEAT FROMSUBCUTANEOUS LIPID-RICH CELLS”、公开号为No.2007/0198071的美国专利；发明名称为“COOLING DEVICES WITH FLEXIBLE SENSORS”、公开号为No.2008/0077201的美国专利；
发明名称为“COOLING DEVICES HAVING A PLURALITY OFCONTROLLABLE COOLING ELEMENTS TO PROVIDE A PREDETERMINEDCOOLING PROFILE”、公开号为No.2008/0077211的美国专利；
发明名称为“METHOD AND APPARATUS FOR COOLINGSUBCUTANEOUS LIPID-RICH CELLS OR TISSUE”、2007年10月31日申请的、申请号为No.11/933066的美国专利；
发明名称为“LIMITING USE OF DISPOSABLE PATIENT PROTECTIONDEVICES”、2007年7月13日申请的、申请号为No.11/777995的美国专利；
发明名称为“SYSTEM FOR TREATING LIPID-RICH REGIONS”、2007年7月13日申请的、申请号为No.11/777992的美国专利；
发明名称为“MANAGING SYSTEM TEMPERATURE TO REMOVE HEATFROM LIPID-RICH REGIONS”、2007年7月13日申请的、申请号为11/777999的美国专利；
发明名称为“SECURE SYSTEM FOR REMOVING HEAT FROMLIPID-RICH REGIONS”、2007年7月13日申请的、申请号为No.11/778003的美国专利；
发明名称为“USER INTERFACES FOR A SYSTEM THAT REMOVESHEAT FROM LIPID-RICH REGIONS”、2007年7月13日申请的、申请号为No.11/778001的美国专利；
发明名称为“TISSUE TREATMENT METHODS”、公开号为No.2008/0077202的美国专利。
技术领域
本申请通常涉及用于从富含脂质的细胞，诸如皮下富含脂质的细胞中去除热量的治疗装置、系统和方法。
背景技术
过多的身体脂肪，或脂肪组织可存在于人体的各个位置，包括例如大腿、臀部、腹部、膝盖、后背、脸部、胳膊、下颚以及其它区域。而且，过多的脂肪组织被认为会夸大脂肪团的不美的表面，在皮下脂肪突入到真皮并且在皮肤连接至其下的结构纤维束处产生凹坑时形成所述脂肪团。脂肪团和过量的脂肪组织通常被认为是不美观的。而且，显著的健康危险都可能与较高的过多的人体脂肪有关。
现已采用大量方法用于治疗具有过多身体脂肪的个体，并且，在很多情况下，过多皮下脂肪组织的无创去除可以消除不必要的康复时间以及消除与诸如吸脂术的有创操作相关的不适。典型地，用于去除过多脂肪的传统无创治疗包括局部用药、减肥药物、有规律的运动、节食或这些治疗方法的组合。这些治疗方法的一个缺点在于在某些情况下它们可能是无效的或甚至是不可能的。例如，在人身体受伤或生病时，有规律的运动就不是一个可选方案。类似地，减肥药物或局部用药在它们会引起过敏或不良反应时就不是一个可选方案。此外，使用全面或系统的减肥方法通常不能实现在人体选择性区域的减肥。
设计成减少皮下脂肪组织的其它方法包括激光辅助吸脂术和中胚层疗法。较新的无创方法包括经由诸如公开号为No.2006/0036300和专利号为No.5143063的美国专利中所描述的例如射频和/或光能，或者经由诸如专利号为Nos.7258674和7347855的美国专利中所描述的例如高能聚焦超声(HIFU)辐射，将辐射能量施加到皮下富含脂质的细胞。相反，用于通过冷却来无创减少皮下脂肪组织的方法和装置在由Anderson等人发明的、名称为“METHODS ANDDEVICES FOR SELECTIVE DISRUPTION OF FATTY TISSUE BYCONTROLLED COOLING”的美国专利No.7367341以及由Anderson等人发明的、名称为“METHODS AND DEVICES FOR DETECTION AND CONTROL OFSELECTIVE DISRUPTION OF FATTY TISSUE BY CONTROLLED COOLING”的美国专利No.2005/0251120中得以公开，其整体公开内容在此引入作为参考。
附图说明
在附图中，相同的参考标记表示相似元件或动作。附图中元件的尺寸和相对位置不一定是按比例绘制的。例如，各种元件的形状和角度不是按比例绘制的，并且这些元件中的许多都是随意放大和定位的以便改善附图清晰度。而且，所绘制的元件的特定形状不传递关于特定元件实际形状的任何信息，仅仅是为了在附图中容易识别。
图1是示意了根据本发明实施例的用于治疗患者皮下富含脂质的区域的治疗系统的等角视图。
图2是示意了根据本发明实施例的用于治疗患者皮下富含脂质的区域的治疗装置的示意图。
图3是示意了根据本发明实施例的用于治疗患者皮下富含脂质的区域的控制装置的组件的框图。
图4是示意了根据本发明实施例的用于控制患者皮下富含脂质的区域治疗的程序的流程图。
图5A-5C是示意了在患者皮下富含脂质的区域的治疗过程中对象的治疗事件检测的图表。
图6是示意了在患者皮下富含脂质的区域治疗过程中用于检测冷却事件的程序的流程图。
图7是示意了在患者皮下富含脂质的区域治疗过程中用于检测治疗事件的程序的流程图。
具体实施方式
概述
本发明介绍了用于监视以及控制诸如脂肪组织的皮下组织的治疗(包括冷却)的闭合环路的装置、系统和方法。下文提供的一些详细说明是为了描述以下实例和方法，其描述的方式足以使相关领域的技术人员能够实施、制造和使用所述实例和方法。但是，下文描述的一些细节和优点不一定是实施本发明某些实例和方法所必需的技术。此外，技术可以包括其它实例和方法，所述实例和方法落在权利要求的范围内，虽然对其没有进行详细描述。
在该整篇说明书中，“一个实例”、“一个实施例”或“一实施例”表示结合实例描述的特定性质、结构或特征，包括在本发明技术的至少一个实例中。所以，该通篇说明书多处出现的措词“在一个实例中”、“在一实例中”、“一个实施例”或“一实施例”并不必然都是指相同的实例。另外，特定性质、结构、程序、步骤或特征可以任何合适的方式结合在本发明技术的一个或多个实例中。这里给出的标题只是为了方便叙述，而不应解释为限制或解释本发明所要求的技术的范围或涵义。
在此描述的系统和方法用于监视、控制、和/或检测与用于治疗对象的皮下富含脂质的细胞的治疗装置相关的治疗事件。这种系统和方法的具体实施例用于监视、控制、和/或检测与用于从对象的皮下富含脂质的细胞中去除热量的治疗装置相关的治疗事件。在系统的一些实例中，治疗装置将冷却直接应用于皮肤特定区域。在没有正确控制的情况下或由于遭遇不曾预料的环境，诸如冷却治疗的治疗方法不会完全成功。例如，冷却治疗可以引起或促使皮肤冷却，治疗装置可以从患者身上所期望位置移开，和/或治疗质量可能低于特定的标准或阈值。因此，对于对象来说从装置和相关系统中接收治疗是所期望的，除了其它好处之外，所述装置和相关系统能够检测在诸如冷却治疗的治疗过程中可能发生的各种事件。
在一些实例中，系统检测在诸如冷却治疗的治疗过程中的事件并且基于检测结果执行一个或多个动作，诸如切断或减少输送到治疗装置的能量，另外使诸如加热皮肤的可替换治疗能够实施或开始，警告该事件的治疗装置的操作者，存入关于治疗的数据和其它信息，等等。
在一些实例中，系统通过检测皮肤和皮下组织温度中的增加来确定治疗事件的发生。系统可以监视与皮肤接触的治疗装置的温度，以及确定在治疗装置或装置的一部分的温度增加时在皮肤上治疗事件的发生。例如，系统可以确定在与皮肤直接接触的治疗装置的一部分温度增加时的治疗事件的发生。
温度增加的幅度和/或速率可以提供关于治疗事件类型的信息。例如，第一个所测量的温度增加的范围表示冷却事件，而第二个这样的范围可以表示治疗装置的运动事件。
在一些实例中，系统还可以监视治疗装置的位置和/或运动，以及基于这种监视来防止治疗事件的错误或不准确的确定。例如，装置在治疗过程中移动，致使装置接触皮肤的更热的区域、或不再与皮肤接触等等。即，系统记录温度差，所述温度差与正常治疗不一致。系统可以被构造成区分该温度增加和与治疗事件相关的温度增加之间的不同，以及例如提供指示或警报来警告操作者该温度增加的根源。在与治疗事件不相关的温度增加的情形下，系统还可以抑制错误指示，而在与冷却相关的温度增加的情形下，基于检测结果采取任意数目的动作如这里别处所描述的。
在一些实例中，系统依赖于两个或多个温度测量以便在冷却治疗过程中更精确地确定治疗事件，诸如在将装置最初冷却到目标温度时或在装置与目标位置不再接触时。在一些情形，系统可以识别装置接触层内的温度变化，诸如接触皮肤的装置部分。另外，系统可以识别用于冷却的组件内的温度变化，诸如热电冷却器中或临近热电冷却器的温度传感器，所述热电冷却器将接触层冷却到期望温度以便实现期望的皮肤下组织的冷却。然后，系统基于这两个温度变化确定治疗事件。系统还可以使用位于同一层内的横向间隔的温度传感器来作出决定。
合适的治疗系统
图1和随后的讨论提供了合适的治疗系统100的简要、大体描述，其中可以实现本发明的各方面。相关领域的那些技术人员应理解本发明可以由用于治疗患者的其它治疗系统和治疗程序来实施本发明，所述其它治疗系统和治疗程序包括有创的、最小创伤的、其它无创的医疗系统，和/或上述一个或多个的组合。一般而言，在此通常使用的术语“治疗系统”涉及用于医学治疗的上述任何医疗系统种类以及任何治疗规范或医学装置用法。
治疗系统100适于治疗对象的皮下脂肪组织，诸如通过冷却。术语“皮下组织”指位于真皮下方的组织，包括皮下脂肪或脂肪组织，其主要由富含脂质的细胞或脂肪细胞组成。当将皮下组织温度冷却到低于37°时，皮下富含脂质的细胞可以选择性地受到影响。一般而言，患者101的表皮与形成脂肪组织的下面的富含脂质的细胞相比缺乏富含脂质的细胞。因为非富含脂质的细胞比富含脂质的细胞通常能更好的抵挡更冷的温度，则在真皮、表皮和其它周围组织中的非富含脂肪细胞没有受到影响的情况下，皮下富含脂质的细胞可选择性地受到影响。在一些实施例中，治疗系统100可以在从大约-20℃至大约20℃的范围内将冷却温度施加到患者的皮肤上。在其它实施例中，冷却温度可以是从大约-20℃至大约10℃，从大约0℃至大约20℃，从大约-15℃至大约5℃，从大约-5℃至大约15℃或从大约-10℃至大约0℃。
在不受理论限制的情况下，在富含脂质的细胞上冷却的选择性影响被认为导致，例如膜破损、细胞收缩、丧失能力、毁坏、去除、杀死或富含脂质的细胞变化的其它方法。这种变化被认为是由一个或多个机制单独作用或组合作用造成的。可以理解，这个机制或这些机制引发神经元凋亡，所述神经元凋亡被认为是由无创冷却引起的富含脂质的细胞死亡的主要形式。
凋亡，通常还称作“程序性细胞死亡”是遗传导致的死亡机制，通过所述死亡机制，细胞在没有对周围组织导致损害的情况下能进行自我破坏。一系列有序的生化事件导致细胞在形态上发生改变。这些改变包括细胞起泡、细胞膜不对称和连接的缺失、细胞收缩、染色质浓缩和染色体DNA断裂。经由外部刺激诸如低温暴露的伤害是会导致细胞中细胞凋亡的一个机制。在Cryobiology27，439-451(1990)上由Nagle，W.A.，Soloff，B.L.，Moss，A.J.Jr.，Henle，K.J.发表的文章“Cultured Chinese Hamster Cells Undergo Apoptosis After Exposureto Cold but Nonfreezing Temperature”。
不同于细胞坏死(由局部炎症引起的细胞死亡的创伤形式)，凋亡的一方面即为凋亡细胞在细胞膜表面上表达和展示吞噬标记，因此通过巨噬细胞来标记具有噬菌作用的细胞。结果，在没有引起免疫反应的情况下，噬菌细胞可以吞噬并且去除垂死细胞(如富含脂质的细胞)。在富含脂质的细胞中发这些凋亡事件的温度有助于延长和/或持久减少皮下脂肪组织以及皮下脂肪组织的再造。
由冷却引起凋亡的富含脂质的细胞死亡的一个机制被认为涉及在不会导致非富含脂质的细胞中结晶的温度处的脂肪细胞内油脂的局部结晶。结晶的油脂可选择性地破坏这些细胞，导致凋亡(还可以导致坏死，如果结晶的油脂损伤或割裂脂肪细胞的双层脂膜)。破坏的另一个机制包括位于细胞双层脂膜内那些脂质的脂质状态转变，其导致膜破裂，从而导致凋亡。已有文献证明该机制适用于许多细胞类型，并且在脂肪细胞或富含脂质的细胞在经受冷却时是具有活性的。Science，68：939-949(1970)上由Mazur，p.发表的文章“Cryobiology：the Freezing ofBiological Systems”；Cryobiogy，22：128-147(1985)上由Quinn，P.J.发表的文章“ALipid Phase Separation Model of Low Temperature Damage to BiologicalMembranes”；Heart Failure Reviews，8，277-284(2003)上由Rubinsky，B.发表的文章“Principles of Low Temperature Preservation”。但其它被理解的凋亡机能可以存在，其基于与非富含脂质的细胞相比要冷却的富含脂质的细胞的相对敏感性。
除了关于在富含脂质的细胞死亡中的凋亡机制，局部低温暴露也被认为会导致富含脂质的细胞的脂解(即脂肪代谢)并且已经表现出能增强现有脂解，其用于进一步增加皮下富含脂质的细胞减少。Aviation，Space and EnvironmentalMedicine70，42-50(1999)上由Vallerand，A.L.，Zamecnik.J.，Jones，P.J.H.，Jacobs，I.发表的文章“Cold Stress Increase Lipolysis，FFA Ra and TG/FFA Cycling in Humans”。
在各个实施例中，系统100包括控制器、计算装置、数据采集装置、冷却器、以及一个或多个涂抹器。系统可以在各个实施例中使用这些部件来接收治疗轮廓的选择和使用涂抹器来实施所选择的治疗方法。
图1是示意了根据本发明实施例的用于从对象患者101的皮下富含脂质的区域中无创地去除热量的治疗系统100的等角视图。系统100包括治疗装置104，所述治疗装置104包括接合对象101目标区域的涂抹器105。治疗装置104例如可以置于对象101的腹部区域102或者另一个合适的区域用于冷却或从对象101的皮下富含脂质的细胞中去除热量。可以理解的是，治疗装置104和涂抹器105可以被设置成适于不同身体区域和身体部位的多种结构、形状和尺寸，因此可以达到用于从对象101的皮下富含脂质的区域中去除热量的任何合适区域。
诸如涂抹器105的涂抹器是系统100的一个部件，所述系统100冷却对象101的区域，诸如人体或动物体(即，“患者”)。在治疗过程中可以应用各种类型的涂抹器，诸如真空涂抹器、带式涂抹器(其与按摩或振动功能之一结合使用)等等。每个涂抹器都可以被设计成治疗患者身体上标记的一部分，诸如下颚、脸颊、胳膊、胸部、大腿、小腿、臀部、腹部、“赘肉”(“love handles”)、后背等等。例如，可以将真空涂抹器应用于后背区域，以及带式涂抹器可以应用于大腿区域周围，在具有或者不具有按摩或振动的情况下。与系统100合用的例证性涂抹器和它们的结构在诸如公开号为Nos.2007/0198071、2008/0077201和2008/0077211的共同转让的美国专利以及申请号为No.11/750953的美国专利中进行了描述。在其它实施例中，系统100还可以包括结合到所述系统100中或被构造成与涂抹器合用的患者保护装置(未示出)，所述患者保护装置防止涂抹器直接接触患者皮肤，从而减少了患者之间交叉感染的可能性，最小化用于涂抹器的清洁需求。患者保护装置还包括或结合各种存储、计算和通信装置，诸如射频识别(RFID)部件，允许用于例如被监视和/或计量。例证性的患者保护装置在公开号为No.2008/0077201的共同转让的美国专利中进行了描述。
系统100还包括治疗单元106，以及在治疗装置104和治疗单元106之间供应和收回流体线路108a-b。治疗单元106从冷却剂中去除热量到热槽以及经由流体线路108a-b为治疗装置104提供已冷却的冷却剂。可替代地，冷却器106在加热期间可以使热的冷却剂循环到冷却装置104。循环冷却剂的实例包括水、乙二醇、合成的热传递流体、油、致冷剂和/或其它合适的热传导流体。流体线路108a-b可以是软管或其它由聚乙烯、聚氯乙烯、聚亚胺酯和/或其它能容纳特殊循环冷却剂的材料构成的管道。治疗单元106可以是致冷单元、冷却塔、热电冷却器或冷却器，或能够从冷却剂中去除热量的任何其它装置。可替代地，市政水供应(即，自来水)可以用于代替治疗单元。此外，本领域技术人员应认识到可以使用大量其它的冷却技术，因此无需将治疗单元或冷却器限于那些在此的描述。
在该实例中，治疗装置104包括至少一个涂抹器105和至少一个治疗单元。涂抹器105可以提供机械能量以产生振动、按摩和/或震动效果。涂抹器105可以包括一个或多个致动器，诸如具有偏心重的马达，或其它振动马达如液压马达、电动马达、气动马达、螺线管、其它机械马达、压电振动器等等，以便对治疗位置提供振动能量。其它实例包括大量致动器，用于连接在任何期望组合中的单个治疗装置104和/或涂抹器105。例如，偏心重致动器可以与一个治疗装置104或涂抹器105相关，而液压马达可以与相同的治疗装置或涂抹器的另一部分相关。例如，这将为治疗系统100的操作者提供选择，用于在对象101的单个区域内或多个区域之间富含脂质的细胞提供不同治疗。采用一个或多个致动器，以及采用具有治疗装置104或涂抹器105的各种构造和组合的致动器类型都是可能的。
治疗单元可以是Peltier型热电元件，以及治疗装置104具有大量单独可控的治疗单元以产生自定义空间的冷却面和/或随时间变化的冷却面。每个自定义的治疗面可以包括一个或多个片段，而每个片段包括指定的持续时间、目标温度和针对诸如振动、按摩、真空和其它治疗模式的特征的控制参数。具有多个单独可控的热交换单元的冷却装置在公开号为No.2008/0077211的共同转让的美国专利中得以描述。
系统100还包括电源110和可操作地连接到治疗装置104和涂抹器105上的处理单元114。在一个实例中，电源110提供直流电压给热电治疗装置104和/或涂抹器105以便将热量从对象101中去除。处理单元114经由靠近治疗装置104放置的传感器(未示出)通过其它部件之间的电源线116来监视处理参数，以便基于处理参数调节热量去除率。处理单元114还可以监视处理参数以便基于处理参数调节涂抹器105。
如图1所示，处理单元114通过电线112与治疗装置104直接电连通；可替代地，处理单元114经由无线或光通信链接而连接至治疗装置。处理单元114可以是任何处理器、可编程逻辑控制器、分布式控制系统等等。注意，图1示出的是没有任何支撑结构的电源线116和线112。可替代的是，电源线116和线112(包括其它线，但并不限于流体线路108a-b)被包捆塞进或另外由管道或相似结构来保护这样的线，从而加强使用者的安全性和人体舒适性，确保无用的移动(以及由此从对象101中对热量去除的潜在低效率)最小化，以及为系统100提供漂亮的外观。这种管道的实例包括弹性聚合的、纺织的或复合的外壳、可调节臂等。这样的管道(未示出)被设计成(经由可调节性连接等)将管道“设置”在合适位置用于对象101的治疗。
在另一方面，处理单元114可以与输入装置(诸如触摸屏118)、输出装置120和/或控制面板(未示出)电连通或其它方式连通。输入装置可以是键盘、鼠标、触摸屏、按钮、开关、电位计、以上任意组合，以及适于接收使用者输入的任意一个装置或多个装置。输出装置120可以包括显示器或触摸屏、打印机、介质读取器、音频设备、以上任意组合，以及适于给使用者提供反馈的任意一个装置或多个装置。在图1的实施例中，输出装置120是同时具有输入装置118和输出装置的双功能的触摸屏。控制面板可以包括可视化指示器装置或控制设备(光、数字显示器等)和/或音频指示器装置或控制设备。控制面板可以是与输入装置和/或输出装置分离的部件，可以是与一个或多个装置集成在一起，可以是与一个或多个装置部分集成在一起，可以处于另一位置中等等。在替代实例中，控制面板或其各部分(在此描述的)可以被包含到、连接到或集成到治疗装置104和/或涂抹器105。在这个实例中，为了便携，处理单元114、电源110、控制面板、治疗单元106、输入装置118以及输出装置120都由具有滚轮126的支架或手推车126来携带。在替代实例中，处理单元114可以被包含到、连接到或集成到之前描述的治疗装置104和/或涂抹器105和/或患者保护装置上。在另一个实例中，可将各种部件固定地安装在治疗位置处。关于部件和/或治疗装置104、治疗单元106、涂抹器105和其它部件的操作的进一步详述可从申请号为No.11/750953的共同转让的美国专利中得到。
在不受理论约束的情况下，可以认为在操作中来自治疗装置的有效冷却取决于大量因素，所述有效冷却通过传导来冷却。影响热量从皮肤区域和相关组织中去除的例证性因素包括治疗单元的表面积、接触元件的温度和输送到组织的机械能。更具体而言，在操作中，一旦接到输入即可开始治疗程序，处理单元114致使涂抹器105循环通过所规定的治疗计划的每个片段。在这样的操作中，涂抹器105为一个或多个治疗装置104供电，诸如热电冷却器(如，TEC”zones”)，以启动冷却循环，例如启动诸如振动、按摩、真空等的特征或模式。使用靠近一个或多个治疗装置104、患者的皮肤、患者保护装置或其它位置或以上组合的温度传感器(未示出)，处理单元114确定温度或热流量是否足够接近目标温度，或热流量已经达到所需。可以理解的是，当人体区域(如脂肪组织)已经冷却或加热到目标温度或通过目标热流量时，事实上人体区域可以接近但不等于目标温度，例如因为人体的自然加热或冷却变化。所以，即使系统尝试加热或冷却至目标温度或通过目标热流量，但传感器只能测量到足够接近的温度。如果没有达到目标温度，可以根据需要来增加能量或减少能量以改变热流量，从而维持目标温度或“设定点”。当所规定的片段持续时间终止时，处理单元114可以应用在下一个治疗面片段中指示的温度和持续时间。在一些实施例中，可以使用变量，而非或除了电源来控制温度。
虽然在此示意并讨论了无创涂抹器，但还可以利用最下化侵入的涂抹器。在这样的情形，涂抹器和患者保护装置可以集成。作为实例，可以直接插入到皮下脂肪组织以便冷却或冷冻脂肪的冷冻探针是这种最小化侵入的涂抹器的实例。由例如Endocare，Inc.，of Irvine，California制造的冷冻探针就适于这种应用。该专利申请通过参照名称为“DEVICE FOR BIOPSY AND TREATMENT OFBREAST TUMORS”的美国专利No.6494844；名称为“DEVICE FOR BIOPSY OFTUMORS”的美国专利No.6551255；名称为“ROTATIONAL CORE BIOPSYDEVICE WITH LIQUID CRYOGEN ADHESION PROBE”、公开号为No.2007-0055173的美国专利；名称为“METHOD AND SYSTEM FORCRYOABLATING FIBROADENOMAS”的美国专利No.6789545；名称为“CRYOTHERAPY PROBE”、公开号为No.2004-0215294的美国专利；名称为“CRYOTHERAPY SYSTEM”的美国专利No.7083612以及名称为“METHODSAND SYSTEMS FOR CRYOGENIC COOLING”、公开号为No.2005-0261753的美国专利得以结合。
根据系统的实例，涂抹器105和治疗装置104组合以加强冷却脂肪组织的分解。此外，实例可以提供较少的治疗时间、减轻患者的不适感以及增加的治疗效率。
系统的实例可以提供治疗装置104和涂抹器105，其通常在对治疗区域中非富含脂质的细胞的没有间接损伤的情况下，能损伤、伤害、分解或以其他方式减少皮下富含脂质的细胞。一般而言，可以认为富含脂质的细胞可以选择性地受到影响(如，被损伤、伤害或分解)，其影响是通过将这种细胞暴露于低温，但对非富含脂质的细胞不起作用。结果，诸如皮下脂肪组织的富含脂质的细胞会受到损伤，而相同区域的其它细胞则通常不会受到损伤，即使位于表面的非富含脂质的细胞经受更低的温度。由涂抹器提供的机械能可以通过对所影响的富含脂质的细胞进行机械分解而进一步加强对富含脂质的细胞的影响效果。
在系统的一些实例中，如在公开号为No.2007/0255362的共同转让的美国专利中所描述的，冷冻保护剂与治疗装置一起使用，在其它优点之间，有助于防止治疗过程中非富含脂质的细胞(如真皮组织)的冷却。
在一个操作模式中，将涂抹器连接到治疗装置上。治疗装置可以被构造成手持式装置，诸如在名称为“TREATMENT DEVICE FOR REMOVING HEATFROM SUBCUTANEOUS LIPID-RICH CELLS”、2006年2月22日申请的、申请号为No.11/359092、共同转让的美国专利中所公开的装置，其整体公开内容在此引入作为参考。
将具有压力或真空型力的治疗装置应用到对象的皮肤上或加压皮肤是有利的以便实现有效治疗。一般而言，对象101具有大约37℃的体温，血液循环是用于维持恒定体温的一项机能。结果，流过需治疗的区域的皮肤和皮下层的血液可以被看作是阻碍皮下脂肪的冷却的热源。这样，冷却感兴趣的组织不仅需要从这种组织中去除热量还需要去除通过该组织的血液循环。因此，临时去除或排除通过治疗区域的血流，是通过如下方式，如应用具有压力的治疗装置，可以提高组织冷却的效率并且避免过多的热量从真皮和表皮中流失。另外，真空可以将皮肤从身体上推开，其有助于冷却下面的组织。
通过将皮下组织冷却到低于37℃的温度，皮下富含脂质的细胞可选择地受到损伤。一般而言，对象101的表皮和真皮与形成皮下组织的下面的富含脂质的细胞相比具有更少量的不饱和脂肪酸。因为非富含脂肪的细胞通常比富含脂质的细胞可以更好的抵抗更冷的温度，所以皮下富含脂质的细胞可选择地受到伤害从而维持真皮和表皮中的非富含脂质的细胞。示例的范围可以从大约-10℃到大约0℃。
图2是示意了用于从皮下富含脂质的细胞中去除热量的治疗装置104的示意图。治疗单元104可以包括冷却单元，诸如冷却板210和接触层220。接触层220可以是板、薄膜、盖或其它在此描述的合适材料，并且可以用作在此描述的患者保护装置。接触层220位于冷却板210和对象(未示出)的皮肤230之间，所述对象的皮肤诸如经由治疗装置104来接收治疗的患者皮肤。冷却板210可以包含与在此描述的控制装置240通信的通信部件215，以及测量冷却板210温度的温度测量部件217。接触层220还包括相似的通信部件225和测量接触层220温度的温度测量部件227。例如，通信部件215、225和/或两者可以接收和传输来自控制装置240的信息，诸如由温度测量单元217、227和/或两者确定的温度信息。装置104还可以包括电源部件和参照图1和相关应用所描述的其它部件。
在许多情形中，治疗装置可以包括具有用于接触患者皮肤的套管和/或接触层的装置。例如，治疗装置可以包括具有第一套管部和第二套管部的套管。第一套管部可接触患者的皮肤和/或便于治疗装置与患者皮肤的接触。第二套管部可以是从第一套管部延伸的隔离层。例如，第二套管部可由乳胶、橡胶、尼龙、Kevlar(R)或其它基本上不能渗透或半渗透材料构成。第二套管部可以防止患者皮肤和冷却板之间的接触，在其它部件之间。关于套管装置的进一步详述可以在公开号为No.2008/0077201的美国专利中了解到。
在许多情形中，治疗装置可以包括含有带的装置，所述带有助于在治疗装置(诸如经由接触层)和患者皮肤之间形成接触。例如，治疗装置可以包括连接到框架上的保持装置。保持装置通过保持装置连接元件可旋转地连接到框架上。保持装置连接原件例如，可以是销、球形接头、轴承或其它类型的可旋转连接。可替代地，保持装置可以刚性地固定到冷却元件外壳的端部。关于带装置的进一步详述可以从公开号为No.2008/0077211的美国专利中得到。
在许多情形中，治疗装置可以包括具有真空的装置，其有助于在治疗装置(诸如经由接触层)和患者皮肤之间形成接触。例如，治疗装置可以为治疗区域提供机械能。通过针对对象的组织重复应用和释放真空来为患者的组织提供机械振动能量，例如在治疗过程中产生按摩动作。关于真空型装置的进一步详述可以从申请号为No.11/750953的美国专利中得到。
图3是示意了控制装置240的框图，所述控制装置240与用于从皮下富含脂质的细胞中去除热量的治疗装置104进行通信。控制装置240包括处理器310，所述处理器310可以包括输入部件、数据库部件、处理部件、输出部件和其它部件。处理器310可以存储或恢复数据以及来自数据库320的其它信息，所述数据库320诸如存储器或其它部件。控制装置240还包括治疗装置监视部件330和治疗装置控制部件340。部件330和340分别用于监视治疗装置104的操作以及控制治疗装置104的操作。例如，部件330可以执行或接收涉及治疗装置104的部件的温度测量值，以及部件340可以基于这些测量值来操作治疗装置。另外，部件330可以执行或接收涉及治疗装置104的运动或位置的测量值，以及部件340可以基于这些测量值来操作治疗装置。例如，在冷却操作或治疗装置104的其它使用过程中，监视部件330使用在此描述的系统来识别一个治疗事件何时发生，或者估计一个治疗事件何时会发生。一旦接收到这种识别，监视部件330可以警告执行动作的控制部件340以改变或暂停治疗。处理器310可有利于部件之间的数据流动，以及可以针对如下信息搜索数据库320，诸如限定治疗事件的信息、涉及患者的信息和其它患者信息。
如在此所描述的，系统可以使用各种不同类型的装置对患者进行冷却。
在从细胞中去除热量的过程中监视、控制和探测事件
如上所述，系统在冷却治疗的过程中探测事件，诸如皮下组织的过度冷却过程中的皮肤冷冻、皮下组织冷却过程中的皮肤冷冻、治疗装置向皮肤更温暖区域的运动、治疗装置提升离开皮肤、未达要求的治疗效果，等等。
在一些实例中，系统执行治疗装置的闭合环路控制，诸如使用治疗装置内的温度部件或传感器的冷却的闭合回路控制。例如，如在此所述的，系统包括包括治疗装置和控制装置，所述治疗装置对患者皮肤下的皮下组织的进行传导性冷却的治疗装置，所述控制装置控制给予治疗装置的能量以降低装置的温度从而冷却皮下组织。系统包括监视皮下组织的冷却的部件，并且执行如下动作，诸如在皮下组织的冷却过程中防止皮肤冷冻的动作。例如，部件探测位于治疗装置和皮肤之间的接触界面处的温度变化。部件可以包括程序、算法、可执行脚本、或其它数据结构、或能够探测温度变化和基于所探测温度变化执行动作的程序模块。
在皮下组织的冷却或过度冷却的过程中，组织温度达到0℃以下，诸如大约-10℃和大约0℃之间的温度。在许多情形中，真皮组织(即皮肤)温度还可以达到0℃以下，诸如低于生物组织和流体的冷冻点的温度，近似为-1.8℃。在这些情形中，低于其冷冻点被过度冷却的皮肤可以快速冷冻，结晶并且释放与皮肤结晶化的潜伏热相关的能量。
通过组织温度的增加来表明该被过度冷却的组织的冷冻或结晶，所述组织温度的增加归因于熔化的潜伏热。诸如治疗装置104的接触冷冻或结晶组织的治疗装置试图进一步冷却组织，其导致需增加提供给治疗装置的能量。经由监视部件，系统可以探测治疗装置的温度变化(如装置变得更冷以试图冷却由冷冻过程中结晶化而变热的组织)或供应给治疗装置(如装置从系统中接收更多的能量以提供额外的冷却)中的变化。如下面更详细的描述，系统还可以识别涉及可操作程序中变量的改变以及执行校正动作以便纠正变量。
参照图4，示出了示意程序400的流程图，所述程序400用于控制在临近皮下富含脂质的细胞的皮肤处进行的治疗事件中从皮下富含脂质的细胞中去除热量。在步骤410，系统测量皮肤上一位置处温度的变化。例如，系统测量在预定或预先确定的时间间隔中的接触层220的温度。可替代地，系统可以连续监视接触层220的温度和/或测量某时间处的温度以及计算温度的时间变化率。
在步骤420中，系统确定温度变化是正的(增加)还是负的(减少)。如果温度变化是正的，程序400进入到步骤430，否则程序继续回到步骤410并且继续监视装置，或者在其它情形中结束。在许多情形中，系统只有在温度变化高于针对变化的阈值时才探测到正的温度变化。例如，沿着正方向的小温度变化可以不表示治疗事件，尤其是之后跟随负的温度变化或没有变化。因此，系统可以只考虑如下温度的变化，即所述温度的变化满足幅度变化和/或速度变化的阈值。所以，在许多情形，系统能防止小的温度变化引起错误的警报，所述错误的警报是关于错误的治疗事件和不会反作用程序的其它最小的程序变量。
在步骤430，一旦探测到正的温度变化，系统执行如下动作，诸如识别或阻碍治疗事件的预防性动作。例如，系统可以关闭给予治疗装置的电源，可以增加治疗装置的温度以便加热皮肤的冷冻或冻结区域，可以警告治疗装置的使用者将治疗装置从对象中移除或者执行其它预防性测量，可以向保留装置的可操作数据的数据库或涉及对象的数据库发送信息，等等。例如也可以利用各种动作的组合，诸如同时警告所探测冷冻事件的操作者和加热治疗装置。
在许多情形，程序400可以监视由治疗装置使用的电源，诸如由装置内的热电冷却器使用的电源。可替代地，程序400可以监视电源代替品，诸如电流，由治疗装置使用的控制器中的脉冲宽度模拟占空因数，等等。一旦皮肤处的治疗事件和由于冷冻事件的皮肤随后加热的发生，则供应给治疗装置的电源能量增加。例如，为了将治疗装置维持在特定温度，系统被构造成在探测这种升温时向热电冷却器提供额外的能量。程序400可以探测能量的增加，诸如能量尖峰，以及执行步骤430中描述的一些或全部动作。
实例治疗事件
图5A-5C是示意了治疗事件的图表，所述治疗事件可以发生在利用系统100将热量从皮下富含脂质的细胞中去除过程中对象皮肤上的一位置处。参照图5A，示出了所测量的治疗装置的温度(诸如针对接触层和冷却板的温度)相对时间的曲线，其表示治疗过程中横向运动事件。在治疗过程中，接触层的温度(SLV1)升高而其它温度以最小化改变。使用这种反馈，系统可以探测到，诸如套管装置的治疗装置已经从患者皮肤上的治疗区域移走。
参照图5B，示出了所测量的装置的温度相对时间的曲线，其表示提升离开事件。在治疗过程中，套管温度升高而板温度降低。使用这种反馈，系统可以探测到，治疗装置已经被提升离开、移除、分离、部分分离，或其它与患者皮肤上的目标位置不接触或部分不接触。
参照图5C，示出了所测量的装置的温度相对时间的曲线，其表示冷冻事件。在治疗过程中，套管温度(SLV1)升高而板温度(TEC1)也升高，尽管升到较小的幅度并且具有较小的变化率。使用这种反馈，系统可以探测到，冷冻事件已经发生在患者皮肤上。
冷却治疗过程中治疗事件的鲁棒探测
如在此所描述的，系统可以使用一个或多个温度传感器来探测治疗装置的温度变化，以及有此可能的异常事件。例如，一个温度传感器可以定位在冷却板210上或里面，而第二温度传感器可以定位在接触层220上或里面。在该实例中，测量在板210和接触层220这两个中的温度变化来减少对冷冻事件的可能错误探测，所述冷冻事件的可能错误探测是由于将治疗装置提升离开皮肤。相对于皮肤冷冻事件探测的用于一个或多个温度传感器的其它配置和定位，以及用于处理接收来自每个传感器的数据的相应算法都是可能的。
参照图6，示出了示意用于控制从皮下富含脂质的细胞中去除热量的程序600的流程图，如上所述，利用具有两个温度传感器的系统。在步骤610，系统测量冷却板210的温度变化率以及接触层220的温度变化率。在步骤620，如果接触层220的温度变化率是正的，程序600进入到步骤640，否则程序600进入到步骤630，结束或返回到步骤610以及继续监视这两个位置处的温度。
在步骤640，如果系统确定冷却板210的温度变化率是正的，程序600进入到步骤660，否则程序600进入到步骤650并且警告操作者异常和域治疗装置与皮肤没有接触，已经提升离开目标区域，等等。在这些情形，加热接触层220和冷却或稳定冷却板210(由于能量增加)的探测可以表示治疗装置的未对准或移动以及不是冷冻事件。在这样的情形，治疗装置可以被重新定位在皮肤的目标区域上继续进行治疗。
在步骤660中，在步骤620已经探测到接触层220正的温度变化率以及在步骤640已经探测冷却板210正的温度变化率，系统确定皮肤位置处的冷冻事件。所以，通过测量接触层和冷却板(诸如热电冷却器)的温度变化率，系统能确定可能的冷冻事件和治疗装置运动之间的不同。
在许多实例中，程序600可以测量供应给治疗装置的能量，其涉及冷却板210和/或接触层220的温度变化。例如，在步骤640，系统可以确定能量的增加和冷却板210的负的温度变化率，以及进入到步骤660。
系统可以通过增加所探测温度的信噪比而增加可能的冷却事件的精确探测度。在许多情形，测量在接触层220处的温度变化率提供高的信噪比，部分是由于能够控制探测环境。例如，系统可以精确控制接触层温度，引导将噪声引入到温度测量信号中的较小的寄生现象。另外，皮肤越冷信噪比越高，对于更严重的冷冻事件提供更精确的测量。在许多情形，系统可以在数秒时间对温度或能量的变化率进行平均，以减少或移除背景噪声的影响。涉及测量值的变化率的平均值的预定阈值可以引发警告或待执行的动作从而校正或防止冷冻事件发生。例如，当治疗装置达到阈值时，通过控制装置来切断供应给装置的能量。
如在此所描述的，系统还可以确定冷却治疗过程中温度变化的范围，基于所确定范围探测治疗事件，以及执行适于所探测事件以及与其相关的动作。参照图7，示出了示意用于探测治疗事件的程序700的流程图。
在步骤710，针对在冷却治疗中使用的治疗装置，系统计算接触层(如套管)温度差以及板温度差。即，系统计算针对治疗装置的套管或冷却板的温度变化。系统可以执行一组计算，诸如三个计算或更多或更少。在步骤720中，系统将所计算的温度差和阈值进行比较。例如，系统可以使用4摄氏度作为阈值用于套管温度差，以及1摄氏度作为阈值用于板温度差。在步骤730中，系统基于比较结果来探测治疗事件。治疗事件可以是冷冻事件、提升离开事件或运动事件。
下面实例示意了在冷却治疗过程中使用程序700如何探测各种事件。
在第一治疗过程中，系统在4摄氏度阈值以上探测针对套管的温度差，以及探测针对板的温度差是在1摄氏度以上但低于2摄氏度。使用所探测的温度，系统确定发生冷冻事件。
在第二治疗过程中，系统探测针对套管的温度差是在4摄氏度阈值以上，以及探测针对板的温度差是在2摄氏度以下。使用所探测的温度，系统确定发生提升离开事件。
在第三治疗过程中，系统探测针对套管的温度差是在1摄氏度和5摄氏度之间，以及执行合适的动作。针对不同的温度差，系统执行与那个温度差相关的动作。例如，对于在1摄氏度和3摄氏度之间的所有温度差，系统更新信息的治疗记录。但是，在该实例中，对于3摄氏度以上的温度差，系统关闭治疗装置。
当然，系统可以基于其它阈值范围和/或值探测事件。例如，系统可以执行基于算法、比较结果或处理结果的一个或多个规则，其是为了探测基于所测量的温度变化的事件。
对移动进行探测以防止治疗事件的错误探测
在许多实例中，治疗装置104包含位置探测或其它基于运动的传感器，在具有或不具有温度传感器的情况下。有时，治疗装置在治疗过程中可能有意或无意的运动。这种运动可以引发如由治疗事件引起的相似的温度响应。所以，系统可以包含探测装置运动和向控制部件指示运动的部件，来防止由于错误警报导致的治疗的过早中断。用于探测运动的传感器类型实例包括加速计、光传感器等等。
在许多实例中，系统可以包括大量传感器，其位于治疗装置的中心区域以及治疗装置的边缘，用于探测治疗装置104的非期望运动。所以，由于装置104相对皮肤230的运动，传感器阵列有利于防止治疗过程中的多余中断。
治疗事件的其它探测
在许多实例中，系统可以使用受温度变化影响的所测量的特征来探测治疗事件。例如，在治疗装置冷却到期望温度的过程中，能量最初增加然后随着温度达到期望温度而降低，并且在期望温度处保持基本一致。
例如，系统测量治疗装置的温度的时间变化率，诸如接触层的温度的时间变化率，以及测量供应给装置104的能量的时间变化率。一旦测量供应给装置的能量的增加以及温度的增加，系统确定对象的皮肤处发生治疗事件。所以，治疗装置104温度的时间变化率中的增加以及能量变化的同时增加表示治疗装置104的最初冷却周期内的可能的治疗事件。
在许多情形，治疗事件可以在最初的冷却周期内发生，其很难被探测到，这是因为治疗装置的温度和治疗装置的能级可能快速变化(关于在冷冻事件过程中发现的变化)。所以，在许多情形，系统可以快速降至中间温度(在组织没发生冷冻处，如，0摄氏度)，然后缓慢地降至目标温度。在这些情形，由于冷冻事件或其它变化，能级的任何跳跃或温度的突变便更易识别出，因为能量和温度为了提供冷却也不是快速变化的。
结论
在此描述的系统和方法监视和控制对患者皮下组织的冷却的应用。系统探测治疗事件，诸如患者皮肤的冷冻，以及执行与所探测事件相关的动作。
除非上下文清楚地有另外的要求以外，在整个说明书和权利要求书中，词语“包括”和类似的词语应以包含的意义来解释，而不是排他或穷举的意义；也就是说，以“包括但不局限于”的意义来解释。使用单数或复数的词语也分别包括复数或单数。当权利要求书使用词语“或”来指两个或多个项目的列表时，该词语涵盖词语的所有下列解释：在该列表中的任意项目、在该列表中的所有项目以及该列表中的项目的任意组合。
上述各种实例可以加以组合来提供其它的实例。在该说明书中提到的和/或在申请数据表中列出的所有美国专利，美国专利公开文本、美国专利申请、外国专利、外国专利申请和非专利公开其整体公开内容在此引入作为参考。如果有必要，可以对技术方面进行修改以使用具有多个治疗单元的治疗装置，具有各种构造的热传导性装置和各个专利、申请和公开的概念以提供其它发明实例。
根据上面的详细描述，可以对技术进行这些和其它改变。一般而言，在下面的权利要求书中，所用的术语不应被解释成将本发明局限于本说明书和权利要求书所公开的特定实施例，而应解释为包括根据权利要求书能执行的所有冷却。相应地，本发明并不受所公开内容的限制，但是其保护范围反而完全由下面权利要求来确定。

Claims (11)

1.一种用于从对象的皮下富含脂质的细胞中经过皮肤去除热量的无创治疗装置，包括：
治疗单元，其被构造成接触患者的皮肤区域，从位于所接触的皮肤区域下方的皮下富含脂质的细胞中去除热量；
探测单元，其与所述治疗单元通信，所述探测单元测量所述治疗单元、以及所述治疗单元和皮肤区域之间的接触界面中至少一个的温度；以及
控制单元，其一旦确定至少部分皮肤冷冻则更改治疗操作，
其中所述控制单元一旦从探测单元接收到所述探测单元测量的正的温度变化的指示则确定至少部分皮肤冷冻。
2.如权利要求1所述的治疗装置，其中所述治疗单元包括：
去除热量的冷却单元；以及
接触层，其至少部分地布置在冷却单元和所接触的皮肤区域之间；
其中控制单元一旦探测到至少部分接触层的温度增加则确定至少部分皮肤冷冻。
3.如权利要求1所述的治疗装置，其中所述治疗单元包括：
去除热量的冷却单元；以及
接触层，其至少部分地位于冷却单元和皮肤之间；
其中控制单元一旦探测到至少部分接触层的温度增加以及一旦探测到至少部分冷却单元的温度增加则确定至少部分皮肤冷冻。
4.如权利要求1所述的治疗装置，其中所述治疗单元包括：
内部板，其被构造成将温度冷却到0℃以下；
接触层，其部分围绕内部板并接触皮肤区域；
其中控制单元一旦探测到至少部分接触层的温度增加则确定至少部分皮肤冷冻。
5.如权利要求1所述的治疗装置，其中所述治疗单元包括：
内部板，其被构造成将温度冷却到0℃以下；
接触层，其部分围绕内部板并接触皮肤区域；
其中控制单元一旦探测到至少部分接触层的温度增加以及一旦探测到至少部分内部板的温度增加则确定至少部分皮肤冷冻。
6.如权利要求1所述的治疗装置，其中所述探测单元被构造成将所述接触界面的测量的温度差和阈值进行比较，并且基于比较结果向控制单元提供指示。
7.一种用于减少患者皮肤下方的皮下组织中的富含脂质的细胞的设备，包括：
热电冷却器，其被构造成被冷却到富含脂质的细胞的冷冻点以下的温度；
接触层，其位于热电冷却器和皮肤之间并且与皮肤接触，所述接触层被构造成通过热电冷却器而大致冷却到热电冷却器的温度；
温度传感器，其被构造成测量接触层的温度变化率以及热电冷却器的温度变化率；以及
控制器，其被构造成响应于接触层的温度变化率和与被所述设备冷却的皮肤部分冷冻相关的热电冷却器的温度变化率执行一动作。
8.如权利要求7所述的设备，其中执行一动作包括警告与所述设备相关的操作者。
9.如权利要求7所述的设备，其中执行一动作包括对热电冷却器加热。
10.如权利要求7所述的设备，其中执行一动作包括关闭通向热电冷却器的电源。
11.如权利要求7所述的设备，其中执行一动作包括使用所述设备将数据传输到与当前治疗相关的记录上。
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