CN108472151B - 在组织冷却期间施用器与皮肤之间的温度依赖性粘附 - Google Patents
在组织冷却期间施用器与皮肤之间的温度依赖性粘附 Download PDFInfo
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- CN108472151B CN108472151B CN201780006039.6A CN201780006039A CN108472151B CN 108472151 B CN108472151 B CN 108472151B CN 201780006039 A CN201780006039 A CN 201780006039A CN 108472151 B CN108472151 B CN 108472151B
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Abstract
根据本发明的具体实施方式的方法和设备包括将粘合剂施加到人对象皮肤上。然后使施用器与粘合剂接触,使粘合剂置于施用器和对象皮肤之间。启动施用器以经由对象皮肤,经由施用器的传热表面和经由粘合剂来冷却组织区域。当组织区域冷却时,粘合剂也冷却,从而可逆地加强对象皮肤和传热表面之间的粘附并在它们之间形成牢固的粘合。增强的粘附力抑制了施用器相对于皮肤的任何移动。在冷却组织区域之后,粘合剂升温,从而削弱粘附力,这使得施用器的传热表面容易与皮肤分离。
Description
相关申请交叉参考
本申请要求提交日更早的于2016年1月7日提交的美国临时专利申请第62/276,131号的优先权,通过引用将该申请全文纳入本文。
技术领域
本公开涉及组织的冷却,例如在冷冻溶脂(cryolipolysis)和冷冻溶解(cryolysis)的情况下。
通过引用纳入
以下共同转让的美国专利申请和美国专利通过引用整体并入本文:
美国专利公开第2008/0287839号,题为“增强去除来自皮下富脂细胞的热量的方法和具有致动器的治疗设备(METHOD OF ENHANCED REMOVAL OF HEAT FROM SUBCUTANEOUSLIPID-RICH CELLS AND TREATMENT APPARATUS HAVING AN ACTUATOR)”;
美国专利第6,032,675号,题为“用于通过脂肪抽吸术受控去除脂肪组织的冷冻方法(FREEZING METHOD FOR CONTROLLED REMOVAL REMOVAL FATBA TISSUE BYLIPOSUCTION)”;
美国专利公开第2007/0255362号,题为“用于改善皮下富脂细胞冷却的治疗装置的冷冻保护剂(CRYOPROTECTANT FOR USE WITH A TREATMENT DEVICE FOR IMPROVEDCOOLING OF SUBCUTANEOUS LIPID-RICH CELLS)”;
美国专利第7,854,754号,题为“用于从皮下富脂细胞去除热量的冷却装置(COOLING DEVICE FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS)”;
美国专利公开第2011/0066216号,题为“用于从皮下富脂细胞去除热量的冷却装置(COOLING DEVICE FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS)”;
美国专利公开第2008/0077201号,题为“具有柔性传感器的冷却装置(COOLINGDEVICES WITH FLEXIBLE SENSORS)”;
美国专利公开第2008/0077211号,题为“具有多个可控冷却元件以提供预定冷却曲线的冷却装置(COOLING DEVICE HAVING A PLURALITY OF CONTROLLABLE COOLINGELEMENTS TO PROVIDE A PREDETERMINED COOLING PROFILE)”;
美国专利公开第2009/0118722号,于2007年10月31日提交,题为“用于冷却皮下富脂细胞或组织的方法和设备(METHOD AND APPARATUS FOR COOLING SUBCUTANEOUS LIPID-RICH CELLS OR TISSUE)”;
美国专利公开第2009/0018624号,题为“限制使用一次性系统病人保护装置(LIMITING USE OF DISPOSABLE SYSTEM PATIENT PROTECTION DEVICES)”;
美国专利公开第2009/0018623号,题为“用于治疗富脂区域的系统(SYSTEM FORTREATING LIPID-RICH REGIONS)”;
美国专利公开第2009/0018625号,题为“管理系统温度以去除富脂区域的热量(MANAGING SYSTEM TEMPERATURE TO REMOVE HEAT FROM LIPID-RICH REGIONS)”;
美国专利公开第2009/0018627号,题为“用于从富脂区域移除热量的安全系统(SECURE SYSTEM FOR REMOVING HEAT FROM LIPID-RICH REGIONS)”;
美国专利公开第2009/0018626号,题为“用于从富脂区域移除热量的系统的用户接口(USER INTERFACES FOR A SYSTEM THAT REMOVES HEAT FROM LIPID-RICHREGIONS)”;
美国专利第6,041,787号,题为“在冷冻手术期间使用冷冻保护剂化合物(USE OFCRYOPROTECTIVE AGENT COMPOUNDS DURING CRYOSURGERY)”;
美国专利第8,285,390号,题为“监测皮下富脂细胞的冷却,如脂肪组织的冷却(MONITORING THE COOLING OF SUBCUTANEOUS LIPID-RICH CELLS,SUCH AS THE COOLINGOF ADIPOSE TISSUE)”;
美国专利第8,275,442号,题为“用于体型塑造应用的治疗计划系统和方法(TREATMENT PLANNING SYSTEMS AND METHODS FOR BODY CONTOURING APPLICATIONS)”;
美国专利申请序列号12/275,002,题为“具有用于冷却皮下富脂细胞的亲水性储库的设备(APPARATUS WITH HYDROPHILIC RESERVOIRS FOR COOLING SUBCUTANEOUSLIPID-RICH CELLS)”;
美国专利申请序列号12/275,014,题为“具有用于从皮下富脂细胞除去热量的疏水性过滤器的设备(APPARATUS WITH HYDROPHOBIC FILTERS FOR REMOVING HEAT FROMSUBCUTANEOUS LIPID-RICH CELLS)”;
美国专利公开第2010/0152824号,题为“具有中断/恢复能力的用于冷却皮下富脂细胞的系统和方法(SYSTEMS AND METHODS WITH INTERRUPT/RESUME CAPABILITIES FORCOOLING SUBCUTANEOUS LIPID-RICH CELLS)”;
美国专利第8,192,474号,题为“组织治疗方法(TISSUE TREATMENT METHODS)”;
美国专利公开第2010/0280582号,题为“用于从皮下富脂细胞去除热量的装置、系统和方法(DEVICE,SYSTEM AND METHOD FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS)”;
美国专利公开第2012/0022518号,题为“用于体型塑造应用的组合式模态治疗系统、方法和设备(COMBINED MODALITY TREATMENT SYSTEMS,METHODS AND APPARATUS FORBODY CONTOURING APPLICATIONS)”;
美国专利公开第2011/0238050号,题为“用于通过相变冷却剂从皮下富脂细胞非侵入性除去热量的家用施用器及相关装置、系统和方法(HOME-USE APPLICATORS FOR NON-INVASIVELY REMOVING HEATFROM SUBCUTANEOUS LIPID-RICH CELLS VIA PHASE CHANGECOOLANTS,AND ASSOCIATED DEVICES,SYSTEMS AND METHODS)”;
美国专利公开第2011/0238051号,题为“用于通过相变冷却剂从皮下富脂细胞非侵入性除去热量的家用施用器及相关装置、系统和方法(HOME-USE APPLICATORS FOR NON-INVASIVELY REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS VIA PHASE CHANGECOOLANTS,AND ASSOCIATED DEVICES,SYSTEMS AND METHODS)”;
美国专利公开第2012/0239123号,题为“用于从皮下富脂细胞去除热量的具有局部热流区的装置、应用系统和方法(DEVICES,APPLICATION SYSTEMS AND METHODS WITHLOCALIZED HEAT FLUX ZONES FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICHCELLS)”;
美国专利申请序列号13/830,413,题为“用于改变皮下富脂组织的多模态治疗系统、方法和设备(MULTI-MODALITY TREATMENT SYSTEMS,METHODS AND APPARATUS FORALTERING SUBCUTANEOUS LIPID-RICH TISSUE)”;
美国专利申请序列号13/830,027,题为“具有流体混合系统和流体冷却的施用器的治疗系统以及使用该治疗系统的方法(TREATMENT SYSTEMS WITH FLUID MIXINGSYSTEMS AND FLUID-COOLED APPLICATORS AND METHODS OF USING THE SAME)”;
美国专利申请序列号11/528,225,题为“具有多个可控冷却元件以提供预定冷却曲线的冷却装置(COOLING DEVICE HAVING A PLURALITY OF CONTROLLABLE COOLINGELEMENTS TO PROVIDE A PREDETERMINED COOLING PROFILE)”;和
美国专利第8,285,390号,题为“监测皮下富脂细胞的冷却,如脂肪组织的冷却(MONITORING THE COOLING OF SUBCUTANEOUS LIPID-RICH CELLS,SUCH AS THE COOLINGOF ADIPOSE TISSUE)”。
在上述共同转让的美国专利申请和美国专利或通过引用并入本文的任何其他材料与本公开内容冲突的情况下,以本公开为准。
背景
过多的身体脂肪或脂肪组织可能存在于对象身体的各个位置,并可能损害个人外观。下巴和/或脖子周围的过量皮下脂肪可能造成美观上的不讨喜,并且在某些情况下可能产生“双下巴”。双下巴会导致皮肤拉伸和/或下垂,也可能导致不适。此外,浅表脂肪室中过量的脂肪组织会产生松弛的面部结构,例如松弛的下颚,这也会导致不希望的外观。过量的体脂也可以位于腹部、大腿、臀部、膝盖和手臂以及其他位置。
人体的美学改善可以涉及选择性去除脂肪组织。然而,用于此目的的侵入性手术(例如吸脂术)往往与相对较高的成本、较长的恢复时间和增加的并发症风险相关。注射用于减少脂肪组织(例如颏下或面部脂肪组织)的药物可引起明显的肿胀、瘀伤、疼痛、麻木和/或硬结。用于减少脂肪组织的常规非侵入性治疗可包括定期锻炼,外用剂的应用,减肥药的使用,节食或这些治疗的组合。这些非侵入性治疗的一个缺点是它们在某些情况下可能无效或甚至不可能。例如,当一个人身体受伤或生病时,定期锻炼可能无法成为一种选择。又例如,如果外用剂和口服减肥药引起不利的反应(例如过敏性或其他负面反应),则它们是不可选的。另外,非侵入性治疗可能对选择性减少肥胖的特定区域而言是无效的。例如,使用一般或全身性减肥方法通常不能实现颈部、下巴、脸颊等周围局部脂肪的减少。
此外,人体的美学和/或治疗改善可能涉及治疗或改变非富脂组织以及富脂组织,并且同样常规治疗有时不适用于许多对象并且不能有效地针对有效治疗所需的某些组织区域。至少由于上述原因,在人体美容和/或治疗改善这个领域中需要创新。
附图简要说明
参照以下附图可以更好地理解本发明的许多方面。附图中的组件不一定是按比例绘制的。相反,重点是清楚地说明本发明的原理。为了便于参考,在本公开中,相同的附图标记可以用于标识本发明的不止一个实施方式中相同、相似或类似的组件或特征。
图1是根据本发明一个实施方式的对象和用于冷却组织的治疗系统的等距视图。
图2是沿图1中的线A-A截取的截面图。
图3是图1中所示治疗系统的施用器(applicator)的端部平面图。
图4是沿图3中的线B-B截取的截面图。
图5和6是对应于图4的截面图,示出了在安装可移除衬垫之后(图5)以及对图1所示的对象进行冷却程序期间(图6),图1所示治疗系统的施用器。
图7-9是类似于图6的截面图,示出了根据本发明的其他各实施方式的冷却治疗期间治疗界面周围的区域。
图10是图9的一部分的放大图。
图11是类似于图10的截面图,示出了根据本发明另一实施方式的治疗界面处的热传感器。
图12-14是类似于图6的截面图,示出了根据本发明的其他各实施方式的冷却治疗期间治疗界面周围的区域。
图15-18是根据本发明的一个实施方式,在使用图1所示的治疗系统对对象进行冷却治疗期间,图1所示的对象和各不同阶段的附近结构的侧视图。
图19和20是在冷却治疗过程中不同的各个阶段沿着图18中的C-C线截取的截面图。
图21是图20的一部分的放大图。
图22是示出根据本发明一个实施方式的用于冷却组织区域的方法的流程图。
图23是纯粘结剂和稀释粘结剂的粘度对温度的图。
图24是包含70%v/v蔗糖乙酸异丁酸酯(SAIB)和30%v/v二丙二醇的粘合剂的粘度对温度的图。
图25是包含43%w/w果糖和57%w/w甘油的粘合剂的粘度对温度的图。
图26是包含43%w/w果糖和57%w/w甘油的粘合剂的比热和热导率对温度的图。
图27是包含43%w/w果糖和57%w/w甘油的粘合剂的热扩散率对温度的图。
具体实施方式
概述
在冷却治疗期间,保持施用器与接受治疗的组织区域之间的稳定的热和物理接触可能是有用的。当这种热和物理接触被破坏或改变时,组织区域或其部分可能会过早地复温,从而导致治疗效果减弱甚至无效。此外,取决于组织区域和施用器之间的稳定接触,施用器通常包括各种传感器。例如,这些传感器用于检测诸如施用器温度、组织温度、施用器与组织之间的接触质量以及组织性质(例如,阻抗,声学和光学性质等)之类的状况。传感器读数有时用于检测冷冻事件,冷冻事件导致治疗参数响应冷冻事件而改变。当施用器与组织区域之间的物理接触由于任何原因(例如通过患者运动)而被中断时,施用器与组织区域之间的任何得到的X、Y或Z轴运动可以从这些传感器的至少一些中产生严重的信号伪影。这反过来又会导致错误的传感器读数和不正确的纠正动作,如冷却不够或过度冷却,过早报警,过早停止治疗,不正确的冻结事件检测等。
在冷却治疗期间保持施用器与对象皮肤之间稳定的热和物理接触的常规方法包括使用抽吸和/或约束(例如,绑带)。虽然在许多情况下有效,但这些常规方法具有局限性。例如,通过气隙将吸力施加到对象的皮肤,该气隙减少了可用于与施用器进行热和物理接触的皮肤区域。与气隙接触的对象皮肤的面积与吸力的强度成正比。因此,当期望显著的保持强度时,通过抽吸实现这种保持强度可能需要较大的皮肤区域与气隙接触,并因此这些皮肤区域不能用于与施用器的热和物理接触。在经皮冷却的情况下,可用于与施用器进行热和物理接触的对象皮肤的面积减少通常是不理想的。此外,在长时间治疗期间,强吸力可能会不舒服。约束可能会减少或消除抽吸的需要,但只在有限的情况下。例如,与抽吸不同,约束通常不太适合拉动和保持皮肤及下层组织与三维表面接触。此外,当对象由于各种原因而移动时,如上所述,这种移动可能导致错误的传感器读数,错误警报和无效治疗,而使用抽吸和约束通常允许施用器与组织区域之间的过度相对移动。
根据本发明一些实施方式的用于对组织进行冷却的方法以及相关结构和系统可以至少部分地解决与上述常规技术相关联的一个或多个问题和/或其他问题,无论这些问题是否在本文中陈述。根据本发明的至少一些实施方式的方法包括使用温度依赖性粘合剂来粘合以促进施用器与组织区域之间的稳定的热和物理接触。引起这种粘合的粘合剂可以被施加到对象皮肤、施用器的传热表面和中间结构(例如衬垫)中的一个或多个。此外,粘合剂可以独立地施加(例如,作为粘性层)或由吸收性基材承载作为复合结构的一部分。然后,对象的皮肤和施用器的传热表面可以通过在它们之间的粘合剂而相接触。当施用器存在于治疗界面处时,施用器可以经由对象的皮肤,经由施用器的传热表面,经由粘合剂以及经由各种其他中间结构或材料来冷却组织区域。
在组织区域被冷却时,粘合剂也可以被冷却。这种粘合剂的冷却可以明显增强对象皮肤与施用器的传热表面之间通过粘合剂的粘附,由此减少或消除在治疗期间对象皮肤与施用器的传热表面之间的相对移动。通过理论,并且不希望受到这种理论的束缚,响应于冷却的粘合剂粘度(viscosity)和粘合剂粘性(tackiness)的增加可能有助于增强粘附。此外,粘合剂在施用期间可具有足够低的粘度和粘性以易于符合对象皮肤的不规则性,但仍足够高以保持其形状。施用期间的粘度和粘性也可以足够低以允许施用器理想地放置在皮肤上并移动到最佳位置。在组织冷却期间的冷却温度(chilled temperature)下,粘合剂的粘度和粘性可以足够高以促进施用器的传热表面和组织区域之间的稳定的热和物理接触,并且保持施用器相对于皮肤固定在位而无论患者在治疗期间的移动如何。因此,相对于传统的对应物,根据本发明的至少一些实施方式的用于对组织进行冷却的方法以及相关结构和系统具有较少或不需要抽吸、约束和/或其他机构以维持施用器和组织区域之间稳定的热和物理接触。
这里参考图1-27描述根据本发明的几个实施方式的用于对组织进行冷却的方法以及相关结构和系统的具体细节。虽然用于对组织进行冷却的方法以及相关结构和系统在本文中主要或完全就冷冻溶脂和冷冻溶解的内容进行了公开,但是除本文公开的那些之外的其他内容也在本发明的范围内。例如,所公开的方法、结构和系统可以用于上面列出并引用纳入本文的申请和专利中提及的任何相容类型的治疗的情况中。一般应该理解的是,除了本文公开的那些之外的其他方法、结构和系统也在本发明的范围内。例如,根据本发明实施方式的方法、结构和系统可以具有与本文公开的那些不同和/或附加的配置、组件和过程。此外,本领域的普通技术人员将理解,根据本发明实施方式的方法、结构和系统可以没有本文公开的一个或多个配置、组件和/或过程而不偏离本发明。
本文一般使用的术语“治疗系统”是指美容、治疗或其他医学治疗系统,以及任何治疗方案或医疗装置的使用。根据本发明的实施方式构造的至少一些治疗系统可用于减少或消除多余的脂肪组织或其他不需要的组织,或者增强皮肤外观。在许多情况下,治疗系统可以用于各种位置,包括例如对象的面部、颈部、腹部、大腿、臀部、膝盖、背部、手臂和/或脚踝。根据本发明的至少一些实施方式的治疗系统非常适合于目标解剖区域处的组织在美容上的有益改变。一些美容处理可能仅用于改变目标区域以符合美容期望的外观、触感、尺寸、形状和/或其他所需美容特性或特征的目的。因此,美容处理的至少一些实施方式可以在不提供可观的治疗效果(例如,无治疗效果)的情况下进行。例如,一些美容处理可能不包括恢复对象的健康、身体完整性或身体健康。美容方法可以针对皮下区域或真皮区域来改变对象的外观,并且可以包括例如对对象的颏下区域、面部、颈部、踝部区域等进行的处理。然而,在其他实施方式中,理想的治疗可以具有治疗效果,例如血管畸形的改变,包括皮脂腺和汗腺的腺体的治疗,神经的治疗,体内激素水平的改变(通过减少脂肪组织)等等。
说明书中提及的“一个实施例”、“一种实施例”、“一个实施方式”或“一种实施方式”表示结合实施例描述的具体特征、结构或性质包括在本发明的至少一个实施例中。因此,在说明书中各种地方出现的短语“在一个实施例中”、“在一种实施例中”、“在一个实施方式中”或“在一种实施方式中”不一定全部都涉及同一个实施例。此外,具体特征、结构、程序、阶段或特性可以任何合适的方式组合在一个或多个本发明实施例中。本文提供的标题仅为方便起见,不旨在限制或解释本发明的范围或含义。
治疗系统
图1是根据本发明一个实施方式的对象100和用于冷却组织的治疗系统102的部分示意性等距视图。应该理解,本发明的各方面可以用许多不同的治疗系统来实践,其中治疗系统102仅仅是一个例子。如图1所示,治疗系统102可以包括紧密贴合对象身体轮廓的施用器104。在所示实施方式中,施用器104被放置在对象下巴106下方的治疗部位105处。在其他实施方式中,施用器104可被放置在对象身体上的其他合适位置(例如,在腹部、大腿、臀部、膝盖、背部、手臂、脚踝等)。再次参照图1,治疗系统102可以包括被成形为舒适地容纳对象的头部109的头部支撑件108(例如枕头)。治疗系统102还可以包括可拆卸地将施用器104与头部支撑件108连接的约束件110(例如,绑带)。约束件110可以被构造成将施用器104压到与治疗部位105处的对象皮肤111紧密接触。施用器104与对象皮肤111之间的治疗界面处的结构和材料未在图1中示出,将参照后续附图进行描述。
图2是沿图1中的线A-A截取的横截面图。同时参照图1和图2,治疗系统102可以包括控制模块112和连接器114(例如缆线),连接器114在控制模块112和施加器104之间延伸。控制模块112可以包括容纳流体系统118、电源120、抽吸系统122和控制器124的外壳116。流体系统118可以被配置为冷却和循环传热流体(例如,水,乙二醇或油)通过施用器104。例如,流体系统118可以包括合适的流体冷却和流体循环组件(未示出),诸如流体腔室、制冷单元、冷却塔、热电冷却器和/或泵。传热流体可以是具有或不具有相变的传热的传热流体。在一些实施方式中,流体系统118还包括合适的流体加热组件(也未示出),诸如配置为对传热流体进行加热的热电加热器,使得施用器104可以在治疗部位105处提供加热和冷却。在其他实施方式中,治疗系统102被配置为仅用于冷却。
连接器114可包括细长主体126和主体126内的线128(单独标识为线128a-128e)。线128可在控制模块112和施用器104之间纵向延伸。在所示实施方式中,线128包括可操作地连接到流体系统118的供应流体线128a,也可操作地连接到流体系统118的返回流体线128b,可操作地连接到电源120的电力线128c,可操作地连接到抽吸系统122的抽吸线128d和可操作地连接到控制器124的控制线128e。在其他实施方式中,连接器114的对应部分可以除了所示的线之外或者代替所示的线而携带其他合适的线。此外,在通过连接器114连通之外,控制模块112和施用器104还可以被配置为无线连通,或者用无线连通代替通过连接器114的连通。
当使用时,治疗系统102可以将传热流体从控制模块112连续地或间歇地经由供应流体线128a输送到施用器104。在施用器104内,传热流体可以循环以吸收来自治疗部位105的热量。然后,传热流体可以从施用器104经由返回流体线128b流回到控制模块112。对于加温期间,控制模块112可主动加热传热流体,使得温热的传热流体循环通过施用器104。另选或附加的,传热流体可被允许被动地变暖。在所示的实施方式中,施用器104依靠传热流体的循环来维持治疗部位105处的热梯度并由此驱动冷却或加热。在其他实施方式中,施用器104的对应部分可以包括热电元件,其补充或取代传热流体的循环以保持该热梯度。热电元件可以被配置用于冷却(例如,通过珀耳帖效应(Peltier effect))和/或加热(例如通过电阻)。例如,在一些实施方式中,施用器104的对应部分可以依赖于传热流体的循环来驱动冷却并且依赖于热电元件来驱动加热。
控制模块112可以控制抽吸系统122以通过施用器104并通过抽吸线128d在治疗部位105处施加吸力。抽吸可用于将衬垫(未示出)固定到施用器104上,以及/或者用于将在治疗部位105处的皮肤111及下层组织拉动并保持与施用器104或施用器衬垫接触,以及/或者用于其他目的。可以基于治疗部位105处的组织特性、患者舒适度和/或治疗部位105处的温度依赖性粘合剂(未示出)的保持力来选择合适的吸力水平。电源120可以被配置为提供直流电压以经由电力线128c为施用器104的电气元件(例如,热装置和传感器装置)供电。例如,控制模块112可以包括可操作地连接到控制器124的输入/输出装置130(例如,触摸屏)。输入/输出装置130可以显示治疗系统102的运行状态和/或治疗方案的进程。
控制器124可以与施用器104连通,并且可以具有用于使治疗系统102使用施用器104来冷却治疗部位105处的组织的指令。在至少一些实施方式中,控制器124与施用器104经由控制线128e、经由无线通信链路、经由光通信链路和/或经由另一合适的通信链路来交换数据。控制器124可以基于但不限于一种或多种治疗方案和/或患者特定治疗计划(例如在共同转让的美国专利第8,275,442号中描述的那些,该专利通过引用整体并入本文)来监测和调整治疗。合适的治疗方案和患者特定治疗计划可以包括一个或多个分段,每个分段包括温度分布、真空水平和/或持续时间(例如1分钟,5分钟,10分钟,20分钟,30分钟,1小时,2小时等)。
图3是施用器104的端部平面图。图4是沿图3中的线B-B截取的截面图。图5和6是对应于图4的截面图,示出了在安装可移除衬垫131之后(图5)以及对对象100进行冷却处理期间(图6)的施用器104。同时参考图1-6,施用器104可以限定组织接收腔132,并且可以包括在腔132内的传热表面134。传热表面134可以是耐用表面,施用器104通过该耐用表面被配置成冷却治疗部位105处的组织135。在该冷却期间,衬垫131和粘合剂136可以设置在传热表面134和组织135之间。衬垫131可以用于例如帮助在治疗期间保持施用器104干净。下面详细讨论的粘合剂136可以用于例如保持传热表面134和组织135之间的稳定的热和物理接触。衬垫131可以用衬垫粘合剂(未示出)附着到施用器104和/或以另一种合适的方式(例如由施用器104产生的真空)保持在适当位置。当在衬垫131与传热表面134之间存在衬垫粘合剂时,该衬垫粘合剂不需要具有任何特殊性质,例如如下面关于粘合剂136所讨论的温度依赖性粘合能力和/或粘度。
传热表面134可以例如经由控制器124进行温度控制。在所示实施方式中,传热表面134是三维的。在其他实施方式中,传热表面134可以是二维的。如图4所示,施用器104可以包括限定了腔132的主体的杯状部137和限定了腔132的口部的波状唇缘部138。杯状部137可以被成形为适应被拉入腔132中的组织135并且可以充当散热器以促进组织135的冷却。唇缘部138可以被配置成密封地接合对象的皮肤111和/或密封地接合衬垫131、粘合剂136或设置在传热表面134和对象皮肤111之间的其他中间结构或材料。施用器104可以包括位于腔132的最下部处的狭槽139。施用器104还可以包括在腔132内和围绕狭槽139的侧面抽吸端口140和端部抽吸端口142。狭槽139、侧面抽吸端口140和端部抽吸端口142可以经由抽吸线128d并经由施用器104内的附加抽吸线(未示出)可操作地连接到抽吸系统122。在示出的实施方式中,施用器104被构造成,除了利用设置在衬垫131的面对施用器104的表面上的衬垫粘合剂外,还通过在侧面抽吸端口140和端部抽吸端口142处的抽吸将衬垫131保持在腔132内,或者不利用设置在衬垫131的面对施用器104的表面上的衬垫粘合剂而是通过在侧面抽吸端口140和端部抽吸端口142处的抽吸将衬垫131保持在腔132内。
在狭槽139处的抽吸可以将组织135拉入腔132中,并在粘合剂136的帮助下将组织135保持在腔132内。如下所述,粘合剂的拉伸粘合性和粘度可以随着温度的降低而增加,使得由粘合剂提供的初始粘合性可能相对较弱。在其它实施方式中,施用器104的对应部分可以被配置为在没有可移除衬垫的情况下使用,并且侧面抽吸端口140、端部抽吸端口142和狭槽139处的抽吸可以将组织135拉入腔132中并且保持组织135在腔132内。在其他实施方式中,施用器104的对应部分可以具有其他合适的抽吸配置。此外,施用器104的对应部分可以没有抽吸功能,例如当不需要将组织135拉入腔132中并且不需要将组织135保持在腔132内时。例如,施用器104的基本上平坦或稍微弯曲的对应部分可以直接放置在对象皮肤111上而不使用任何抽吸,并且仅用绑带和粘合剂136或仅用粘合剂136保持在位。
再次参考图1-6,施用器104还可以包括在狭槽139下面的流体冷却元件144。流体冷却元件144可以包括通道146,该通道146被成形为以促进经过传热表面134传热的方式传送传热流体。施用器104可以包括分别与供应流体线128a和返回流体线128b连接的入口端口148和出口端口150。通道146可以沿入口端口148和出口端口150之间的蛇形或其他合适的路径延伸。施用器104还可以包括设置在流体冷却元件144和狭槽139之间的热电元件152。流体冷却元件144和热电元件152可以一起使用或分开使用以引起期望水平的冷却或加热。例如,使用流体冷却元件144和/或热电元件152进行加热可以用于促进在冷却过程完成之后将施用器104与治疗部位分离。
图7-9是类似于图6的截面图,示出了根据本发明的其他各实施方式的冷却治疗期间治疗界面周围的区域。具体而言,图7-9显示了治疗界面处的不同粘合剂配置。在图7所示的实施方式中,在衬垫131接触皮肤111之前,将粘合剂136施加到衬垫131上。因此,在不与衬垫131接触的治疗部位105的部分中可以不存在粘合剂136。在一些情况下,粘合剂136被预加载到衬垫131上。例如,衬垫131可以与粘合剂136的层一起包装并且被配置为在单次使用后丢弃。在其他实施方式中,可以恰好在治疗开始之前(例如就在衬垫131可移除地连接到施用器104之前或之后)将粘合剂136施加到衬垫131上。在图8所示的实施方式中,施用器104不包括衬垫131,粘合剂136直接设置在皮肤111和传热表面134之间。例如,当不需要保护粘合剂136时,例如当粘合剂136是水溶性且传热表面134不含粘合剂136可嵌入其中的间隙和裂缝时,该设置可能是理想的。在这些和其他情况下,狭槽139、侧面抽吸端口140和端部抽吸端口142可以包括防止粘合剂136被吸入到抽吸系统122中的过滤器(未示出)。
在图9所示的实施方式中,粘合剂136由设置在对象皮肤111和施用器104的传热表面134之间的吸收性基材160承载。粘合剂136和吸收性基材160一起可形成复合结构162,其被配置为设置在治疗界面处。例如,吸收性基材160可用于促进低粘度下粘合剂136的施加,将粘合剂136保持在治疗界面处的位置,减少或防止在施用器104放置期间粘合剂136的位移,和/或确保在施用器104与对象皮肤111之间存在连续的材料层。确保施用器104与对象皮肤111之间存在连续的材料层还可以确保施用器104的任何部分都不直接接触对象的皮肤111。当使用过冷治疗温度时,施用器104与对象皮肤111之间的这种直接接触可能是不利的,因为它可能无意地接种(inoculate)皮肤111并在其中引起过早冻结事件。
在一些实施方式中,吸收性基材160为管状且可拉伸,使得其可围绕对象的颈部、手臂、腿、躯干等放置。在另一些实施方式中,吸收性基材160可以是平坦或弯曲的垫或具有其他合适的用于与治疗部位进行最佳接触并且易于施加和移除的形式。吸收性基材160可以包括适于携带粘合剂136的可拉伸织物、网状物或其它多孔材料。棉、人造丝和聚氨酯布是适用于吸收性基材160的材料的几个例子。此外,吸收性基材160可以包括导热材料,该导热材料至少部分地补偿相应粘合剂136的较低的热导率。因此,在一些情况下,复合结构162比单独的粘合剂136更具导热性。例如,较高的热导率可用于促进在冷却过程期间检测冻结事件的热信号。当吸收性基材160包括可拉伸织物时,织物的一些或全部纤维可以由导热材料制成。例如,织物可以包括金属纤维,碳纤维和/或具有导热涂层的纤维。碳纤维织物可以例如以FLEXZORB商标从美国宾夕法尼亚州匹兹堡的卡尔冈碳素公司(Calgon Carbon(Pittsburgh,PA))获得。吸收性基材160的这些和其他形式可以被构造为一次使用或者多次使用,并且可以在预加载或者未预加载粘合剂136的情况下包装。当吸收性基材160被预加载粘合剂136时,相应的复合结构162可以被包封在防潮包装(未示出)中以保护成分粘合剂136免受环境影响。此外,复合结构162可与衬垫131分开包装,或与衬垫131一起包装。在特定实施方式中,复合结构162预先定位在衬垫131上,使得复合结构162和衬垫131可简单地就与对象皮肤111接触,而不需要单独定位复合结构162。在另一个实施方式中,复合结构162独立于衬垫131,并且被配置为在建立与施用器104的热和物理接触之前被放置在对象的皮肤111上。
图10是图9的一部分的放大图。图11是类似于图10的截面图,示出了根据本发明另一实施方式的治疗界面处的热传感器164。如图11所示,热传感器164可由吸收性基材160承载(例如,嵌入到吸收性基材160中)。或者,热传感器164的对应部分可由施用器104的另一合适部分104,例如施用器104的传热表面134来承载(例如,嵌入到其中)。例如,热传感器164可以用于通过缩短与冻结事件相关的热能在被检测到之前必须传送的距离来促进冻结事件的热信号的检测。热传感器164可以包括延伸出吸收性基材160到达用于连接到外部电子器件的端口(未示出)的导线166。或者,热传感器164可以被配置为无线地与外部电子器件连通。在一些情况下,热传感器164被内置到吸收性基材160中。在其他情况下,热传感器164在使用时被插入到吸收性基材160中。在这些和其他情况下,热传感器164可以是单次使用或多次使用。
图12-13示出了粘合剂136与不同的施用器类型一起使用。在图12所示的实施方式中,显示粘合剂136在治疗部位171处与“夹持型(pinch-type)”施用器170一起使用。施用器170可以包括框架172,该框架172具有可操作地连接到相应的冷却元件176的侧壁174。框架172可以限定端部间隙177,施用器170在该端部间隙177处包括抽吸端口178。在端部间隙177处的抽吸可以便于在组织135开始冷却之前将组织135以在侧壁174之间的捕获状态保持在治疗部位171。在开始冷却组织135之后,粘合剂136可以冷却并且在组织135和侧壁174之间形成强粘合性粘附(adhesive bond)。在至少一些情况下,在组织135和侧壁174之间的粘合性粘附加强之后,端部间隙177处的吸力减小。例如,减小端部间隙177处的吸力可以用于减少或消除最靠近端部间隙177的一部分组织135处的与抽吸相关的血液淤积。关于可以依据本发明的至少一些实施方式与粘合剂136一起使用的“夹持型”施用器的其他细节可以参见例如美国专利申请公开第2015/0342780号和美国专利申请第14/662,181号,它们通过引用整体并入本文。
在图13所示的实施方式中,显示粘合剂136与类似于施用器104(图6)的另一个杯型施用器179一起使用。除了在皮肤111和施用器179的传热表面之间不存在端部间隙177之外,施用器179也类似于施用器170(图12)。施用器179可以包括杯状物180和在杯状物180底部的抽吸端口181,该抽吸端口181完全将组织135拉入杯状物180中。与施用器104(图6)和施用器170(图12)类似,施用器179是三维施用器,非常适合用于可以被拉离对象身体的组织。至少在某些情况下,与这些施用器相关的治疗界面也是三维的。然而,应该理解的是,粘合剂也可以与通过二维治疗界面冷却组织的施用器一起使用。
在图14所示的实施方式中,显示粘合剂136在治疗部位183处与“鞍袋型(saddlebag-type)”施用器182一起使用。施用器182可以包括与中央背衬186连接的冷却元件184。施用器182还可以包括连接到相应的外侧背衬190的抽吸元件188。外侧背衬190可以在中央背衬186的相对的相应侧处与中央背衬186铰接连接。最开始可以使用带子(未示出)通过挤压将施用器182固定在治疗部位183处。任选地,在抽吸元件188处的抽吸可以有助于在组织135开始冷却之前将组织135以与冷却元件184稳定接触的状态保持在治疗位点171。在开始冷却组织135之后,粘合剂136可以冷却并且在组织135和冷却元件184之间形成强粘合性粘附,足以将施用器182保持在位而无需继续使用任何带子或抽吸。在至少一些情况下,在组织135和冷却元件184之间的粘合性粘附被加强之后,由带子产生的挤压和/或由抽吸元件188产生的抽吸可被减小或完全消除。例如,减小由带子产生的挤压和/或由抽吸元件188产生的抽吸可以用于增强患者舒适度。关于可以依据本发明的至少一些实施方式与粘合剂136一起使用的“鞍袋型”施用器的其他细节可以参见例如美国专利申请公开第2015/0342780号和美国专利申请第14/662,181号,它们通过引用整体并入本文。
治疗方法
图15-18是根据本发明的一个实施方式,在使用治疗系统102(图1)对对象100进行冷却治疗期间,对象100在各个不同阶段的侧视图。在图15中,显示在治疗开始之前的对象100。在图16中,示出了在粘合剂136已经作为粘性层施用于治疗部位105处的对象皮肤111之后的对象100。可以通过刷涂、涂抹、放置(例如,当粘合剂136由吸收性基材承载时)和/或通过另一种合适的施涂技术将粘合剂136施加到治疗部位105处的皮肤111上。在至少一些实施方式中,粘合剂136在施加温度(例如,室温或体温)下具有足够高的粘度以在皮肤上形成稳定的粘性层,但粘度又足够低以易于符合皮肤中通常存在的不规则性(例如皱纹)。例如,粘合剂136可以在5,000至500,000厘泊范围内的粘度,例如10,000至100,000厘泊范围内的粘度下施加于治疗部位105处的皮肤111。另外,当施加时,粘合剂136可以具有低粘性,粘性在冷却之后大大增加。在施加粘合剂136之后,施用器104可以被提供(图17),然后移动到在治疗部位105处与对象100接触(图18)。在建立这种接触期间和不久之后,鉴于在施用温度下粘合剂136的相对较低的粘度和粘性,可以精确地定位施用器104。
图19和20是在冷却治疗过程中不同的各个阶段沿着图18中的C-C线截取的截面图。当施用器104首先接触治疗部位105时,治疗部位105处的皮肤111和下面的组织135可以大部分位于腔132的外部。由图19中的箭头192表示的吸力可以将皮肤111和下面的组织135吸进腔132中,直到皮肤111和下面的组织135移动到与施用器104的传热表面134发生热和物理接触。组织135和传热表面134之间的热和物理接触可以延伸通过皮肤111,通过粘合剂136,通过衬垫131并通过衬垫131和施用器104的传热表面134之间的任何衬垫粘合剂(未示出)。粘合剂136的厚度可以足以促进皮肤111与传热表面134之间通过衬垫131的粘附,但是又足够薄,不会过度地降低组织135与传热表面134之间的热传导。至少在一些情况下,粘合剂136以0.1至1毫米的范围内的平均厚度存在,例如在0.2至0.5毫米的范围内。在特定的实施方式中,粘合剂136以0.3毫米的平均厚度存在。
当皮肤111和下面的组织135首先移动到与传热表面134发生热和物理接触时,粘合剂136可以在皮肤111和传热表面134之间形成弱粘合性粘附。因此,至少在一些情况下,施用器104在冷却开始之前容易重新定位。例如,当施用器104的初始位置不理想时,重新定位施用器104可能是有用的。一旦施用器104被适当地定位并且组织135和传热表面134彼此热和物理接触(并且当衬垫131不存在时彼此直接物理接触),施用器104可以被启动以从组织135中吸取热量(由图20中的箭头194表示)。以这种方式,施用器104可以经由皮肤111、经由粘合剂136、经由衬垫131、经由任何衬垫粘合剂并经由施用器104的传热表面134来冷却组织135。粘合剂136可以在冷却组织135的同时被冷却。粘合剂136的冷却可以低温加强皮肤111和传热表面134之间的直接或间接粘合性粘附,从而经由粘合剂136和衬垫131加强皮肤111和传热表面134之间的粘附。这样在粘合剂136被冷却时可以抑制或完全防止施用器104相对于皮肤111的移动。
在皮肤111和传热表面134之间的粘合性粘附已经被低温强化之后,施用器104可能不再容易重新定位。在至少一些情况下,随着冷却治疗,粘合剂136从施用温度冷却到冷却温度可以至少将皮肤111和传热表面134之间的粘合性粘附的拉伸强度增加不止1.25倍、1.5倍、2倍、3倍、4倍、5倍、6倍、7倍、10倍、20倍或30倍的倍数。例如,当粘附被低温强化时,在垂直于传热表面134的方向上破坏皮肤111和传热表面134之间的粘附所需的力可以至少是粘附被低温强化之前破坏粘附所需的相应的力的大于1.25倍、1.5倍、2倍、3倍、4倍、5倍、6倍、7倍、10倍、20倍或30倍的倍数。类似地,随着冷却治疗,粘合剂136从施用温度冷却到冷却温度可以至少将皮肤111和传热表面134之间的粘合性粘附的剪切强度相比于低温强化剪切强度之前皮肤111和传热表面134之间的粘合性粘附的剪切强度增加大于1.25倍、1.5倍、2倍、3倍、4倍、5倍、6倍、7倍、10倍、20倍或30倍的倍数。例如,当粘附被低温强化时,在平行于传热表面134的方向上破坏皮肤111和传热表面134之间的粘附所需的力可以至少是粘附被低温强化之前破坏粘附所需的这种力的大于1.25倍、1.5倍、2倍、3倍、4倍、5倍、6倍、7倍、10倍、20倍或30倍的倍数。剪切强度的增加对于防止冷却治疗期间皮肤111和传热表面134之间的任何X、Y轴相对移动可能是重要的。
对于组织被吸入具有侧壁的杯或井中的“杯型”施用器(例如,图6所示的施用器104)或“夹持型”施用器(例如,图12所示的施用器170),剪切强度的增加可以非常有效地减少或消除皮肤和传热表面之间的相对移动。这可以用于减少或消除治疗部位处这些施用器与皮肤之间的“弹开(pop off)”或其他类型的不希望的移位或分离。对于表面施用器(例如,图14中所示的施用器182),增加拉伸强度来防止沿着Z轴的移动可以非常有效地减少或消除皮肤与传热表面之间在Z轴上的相对移动。同样,这可以用于减少或消除治疗部位处这些施用器与皮肤之间的“弹开”或其他类型的不希望的移位或分离。
除了使用所述的能够响应温度变化在粘附力和粘度上表现出较大的可逆变化的粘合剂外,本领域技术人员将认识到,用于形成粘合剂吸收剂(当使用时)、衬垫(当使用时)、传热表面以及可能与粘合剂接触的任何其他组件的材料应与粘合剂相容。例如,可以对这些其他结构和材料进行选择,以优选能够润湿粘合剂并在治疗温度下与其形成强粘合。对于至少一种经过测试的粘合剂的形成,已经发现铝、棉、人造丝和聚氨酯与形成强粘合性粘附是相容的。当携带粘合剂的吸收性基材具有至少稍微多孔的表面时,发现粘合强度增加。
在皮肤111和传热表面134之间的粘合性粘附被低温强化之后,最初用于将组织135推入腔132中的抽吸和/或挤压的程度可能是将组织135的位置保持在腔132中所不需要的。因此,可以降低抽吸和/或挤压的程度,这例如可以有利于在长时间治疗期间增强患者的舒适度和/或减少抽吸和/或挤压的不利的副作用。在一些情况下,在组织135被冷却时,组织135和传热表面134之间的热和物理接触主要或仅仅通过粘附进行。在其他情况下,在组织135被冷却时,保持组织135和传热表面134之间的热和物理接触主要通过抽吸并补充粘附来进行。
在至少一些实施方式中,随着冷却治疗,粘合剂136从施用温度冷却至冷却温度将粘合剂136的粘度在厘泊单位上增加至少1,000%(例如,至少10,000%)。在这些和其他实施方式中,以这种方式冷却粘合剂136可以使粘合剂136的粘度在3,000,000厘泊至在比粘合剂136的玻璃化转变温度更高的温度下粘合剂136的最大粘度的范围内。将粘合剂136冷却到比其玻璃化转变温度更低的温度可以减弱皮肤111和传热表面134之间通过粘合剂136产生的粘附。因此,可以对粘合剂136进行选择,使其具有的玻璃化转变温度低于粘合剂136在冷却治疗期间将被冷却到的最低温度。例如,可以选择粘合剂136以具有低于-20℃、例如低于-30℃的玻璃化转变温度。
根据一个具体实施方式,在室温或另一合适的施用温度下,粘合剂136具有最小的粘附力,使得施用器104可以容易地放置在皮肤111上和从皮肤111上移除,并且根据正确定位施用器的需要侧向移动或扭转。例如,冷却之前的粘附力可能不足以在不使用某种其他保持力的情况下将施用器104保持在精确的位置并且在相当长的一段时间内固定在该位置。然而,在治疗温度下,粘附力急剧增加,使得仅粘附力就足以强大到将施用器104保持在位而无需任何其他附着力。可能变得不必要的其他附着力可以包括抽吸、绑带或甚至借助重力的对象组织135的支撑(例如,如果对象100躺下并且施用器104搁置在对象100上)。换句话说,粘合剂136的强度足以将施用器104在任何取向上固定在位。因此,即使对象100站立并且施用器104简单地悬挂在对象100上,例如从对象的腹部或侧面悬挂,粘合剂136的强度也足以固定施用器104并将其保持在位,并且在用施用器104进行治疗时保持相对于治疗部位处的皮肤111不可移动。此外,粘合剂136的强度不仅可以在对象站立并且施用器104从对象悬挂时足以将施用器104保持在位并且保持其相对于对象皮肤111不会移动,而且即使在对象移动、发抖或者要跳起来和蹲下时也能如此。
图21是图20的一部分的放大图。如图21所示,衬垫131可以在狭槽139的周边处具有圆形边缘196。同时参考图20和21,粘合剂136可以挤压在皮肤111和衬垫131之间,并由此朝向狭槽139移动,朝向唇缘部138上方的区域移动,和/或朝向不存在衬垫131的其他区域移动。例如,在圆形边缘196的更靠近狭槽139的一侧处的粘合剂136可以比在远离狭槽139的圆形边缘196的一侧处更厚。粘合剂136在施加时可以具有足够高的粘度,使得其并没有被完全挤出被牢固地压在衬垫131上的治疗部位105的区域。因为在所示实施方式中,粘合剂136是在对象皮肤111与衬垫131接触之前被施加到对象皮肤111上,所以粘合剂136可以存在于不与衬垫131接触的一部分治疗部位105处,例如在狭槽139处的治疗部位105的一部分。粘合剂136在施加时可以具有足够高的粘度,使得它不会在不与衬垫131接触的该部分治疗部位105处因为抽吸而与皮肤111脱离。然而,在一些情况下,治疗部位105的这些部分处的一些或全部粘合剂136可能由于抽吸而与皮肤111脱离。在这些情况下,施用器104可以包括过滤器(未示出),该过滤器减少或消除释放的粘合剂136被拉入抽吸线和/或端口而堵塞抽吸线和/或端口。
图22是示出根据本发明一个实施方式的用于冷却对象的组织区域的方法200的流程图。为了简单起见,将主要参考施用器104来进一步描述方法200。然而,应当理解的是,方法200在合适的情况下和/或方法200的部分在合适的情况下可以用根据本发明实施方式的任何施用器104、170、179、182或其他施用器进行。同时参考图20-22以及所示的各种先前的图,方法200可包括使皮肤111与施用器104通过它们之间的粘合剂136进行接触(框202)。如上所述,这可以包括将粘合剂136施加(例如,刷涂,涂抹,放置等)到皮肤111上,衬垫131上和/或施用器104的传热表面134上,然后使皮肤111和施用器104彼此热和物理接触。粘合剂136可以是独立的或由吸收性基材(例如,图9所示的吸收性基材160)承载。在至少一些实施方式中,方法200包括将皮肤111推入腔132中(框204)。例如,方法200可以包括至少部分地通过抽吸和/或至少部分地通过挤压将皮肤111推入腔132中。
当组织135经由皮肤111和粘合剂136与传热表面134发生热和物理接触时,方法200可包括冷却粘合剂136(框206)并冷却组织135(框208)。冷却粘合剂136可以包括将粘合剂136冷却到不低于粘合剂136的玻璃化转变温度的温度,例如比粘合剂136的玻璃化转变温度高1℃到比粘合剂136的玻璃化转变温度高10℃的范围内的温度,例如冷却到比粘合剂136的玻璃化转变温度高1、2、3、4、5、6、7、8、9或10℃以上的温度。在至少一些情况下,粘合剂136将被冷却到的温度在-25℃至-1℃,-25℃至-5℃,-20℃至-8℃,或-18℃至-10℃的范围内。粘合剂136的冷却可低温加强皮肤111与传热表面134之间的粘合性粘附。在低温加强粘合性粘附期间和/或在低温加强粘合性粘附之后,可发生组织135的冷却。冷却组织135可以包括经由粘合剂136的粘性层、经由包括吸收性基材160和粘合剂136的复合结构(图9)和/或经由以另一种合适形式施加在施用器104和皮肤111之间的粘合剂136对组织135进行冷却。在至少一些实施方式中,组织135被冷却到足够低的温度以损害或以其他方式破坏皮下富脂细胞和/或皮肤或皮下层中的任何其他目标结构。在这些和其他实施方式中,冷却组织135可以包括将组织135冷却到低于0℃、-5℃、-10℃或低于另一个合适的阈值的温度并保持至少15分钟。
在冷却组织135时,方法200可以包括维持组织135与传热表面134之间的热和物理接触(框210)。粘合剂136可以导致这种热和物理接触比如果粘合剂136不存在时更可靠。在至少一些情况下,在冷却组织135时,皮肤111和传热表面134之间的粘合性粘附可以变得足够强大,以致于至少部分地或全部地替代用于将组织135推进腔132中的抽吸和/或挤压。在这些和其他情况下,方法200可以包括在低温强化粘合性粘附之后和冷却组织135的同时减少或消除抽吸和/或挤压。方法200还可以包括在冷却组织135时将衬垫131的位置保持在腔132中(框212)。例如,衬垫131在腔132内的位置至少主要通过抽吸和/或通过另一种粘合剂来保持,该粘合剂可以具有但不必须具有任何特殊的性质。在皮肤111和传热表面134之间借助于粘合剂136存在强粘合性粘附时,如果需要快速从施用器104释放组织135,则可以释放将衬垫131保持在腔132内的吸力,并且当衬垫粘合剂不存在时,可以利用衬垫131将组织135从腔132中移除。当衬垫粘合剂存在时或者当衬垫131未被使用时,如果需要快速从施用器104释放组织135,则可以快速地再次升温施用器104以将粘合剂136升温到足够高的温度,使得组织135可以容易地从腔132中移除。
如图22所示,方法200还可以包括在冷却粘合剂136之后升温粘合剂136(框214)。这可以减弱皮肤111和传热表面134之间的粘附。在至少一些实施方式中,升温粘合剂136包括将粘合剂136升温至少10℃。此外,升温粘合剂136可以包括主动升温粘合剂136(例如,使用热电元件152)和/或被动升温粘合剂136(例如,通过使未冷却的传热流体通过流体冷却元件144)。粘合剂136的升温可以将粘合剂136的粘度降低至小于1,000,000厘泊。在升温粘合剂136之后,方法200可以包括分离皮肤111和传热表面134(框216)。
根据本发明的至少一些实施方式的冷却治疗可用于减少或消除皮肤、皮下层或其他层中的目标组织,并由此引起组织具有期望的外观。例如,根据本发明的实施方式的治疗系统可以进行医学治疗以提供治疗效果和/或进行美容疗程以获得有益的美容效果。不受理论束缚,认为冷却的选择性效应导致例如皮肤、皮下组织或其他组织中富脂细胞的膜破裂、细胞收缩、丧失机能、破坏、损伤、损坏、去除、杀死、减少和/或其他结果以及非富脂细胞的改变和其他组织的改变。相信这种改变来源于单独或组合起作用的一种或多种机制。据认为,这样的机制触发凋亡级联,其被认为是非侵入性冷却引起的富脂细胞死亡的主要形式。在这些实施方式的任一个中,组织冷却的效果可以是通过期望的作用机制如凋亡、脂解等选择性地减少富脂细胞。在一些过程中,施用器104可以将对象的目标组织冷却至约-25℃至约20℃范围内的温度。在其他实施方式中,冷却温度可以为约-20℃至约10℃,约-18℃至约5℃,约-15℃至约5℃,或约-15℃至约0℃。在另一些实施方式中,冷却温度可以等于或小于-5℃,-10℃,-15℃,或在另一个实施方式中为约-15℃至约-25℃。可以使用其他冷却温度和温度范围。
细胞凋亡,也称为“程序性细胞死亡”,是一种基因诱导的死亡机制,通过该机制细胞自我毁灭而不会对周围组织造成损害。一系列有序的生化事件诱导细胞发生形态学改变。这些改变包括细胞起泡,细胞膜不对称性和附着的丧失,细胞收缩,染色质凝聚和染色体DNA片段化。通过外部刺激例如冷暴露引起的损伤是可以诱导细胞中细胞凋亡的一种机制,Nagle,W.A.,Soloff,B.L.,Moss,A.J.Jr.,Henle,K.J.“培养的中国仓鼠细胞在暴露于冷却但不冻结的温度后发生细胞凋亡(Cultured Chinese Hamster Cells UndergoApoptosis After Exposure to Cold but Nonfreezing Temperatures)”Cryobiology27,439-451(1990)。
与细胞坏死(导致局部炎症的细胞死亡的创伤形式)相反,细胞凋亡的一个方面是凋亡细胞在细胞膜表面表达和展示吞噬细胞标记,因此标记细胞被巨噬细胞吞噬。结果,吞噬细胞可吞没并除去即将死亡的细胞(例如富脂细胞)而不引发免疫应答。在富脂细胞中引发这些凋亡事件的温度可能有助于皮下脂肪组织的持久和/或永久性减少和再成形。
认为通过冷却引起凋亡性富脂细胞死亡的一种机制涉及在不会在非富脂细胞中诱导结晶的温度下脂质在脂肪细胞内的局部结晶。结晶的脂质可能选择性地伤害这些细胞,诱导细胞凋亡(并且如果结晶的脂质损坏或破坏脂肪细胞的双脂质膜,也可能诱导坏死性死亡)。另一种损伤机制涉及这些脂质在细胞双脂质膜内的脂质相变,这导致膜破裂或功能障碍,从而诱导细胞凋亡。这种机制对于许多细胞类型已被充分证明,并且当脂肪细胞或富脂细胞被冷却时可能是活跃的,Mazur,P.,"低温生物学:生物系统的冻结(Cryobiology:the Freezing of Biological Systems)"Science,68:939-949(1970);Quinn,P.J.,"低温生物膜损伤的脂质相分离模型(A Lipid Phase Separation Model of Low TemperatureDamage to Biological Membranes)"Cryobiology,22:128-147(1985);Rubinsky,B.,"低温保存原理(Principles of Low Temperature Preservation)"Heart Failure Reviews,8,277-284(2003)。
美国专利第8,192,474号中描述的其它可能的脂肪细胞损伤机制涉及在如本文所述冷却此类细胞时在某些条件下可能发生的缺血/再灌注损伤。例如,在如本文所述的通过冷却进行治疗期间,目标脂肪组织可能经历血液供应限制,并因此由于施加的压力导致分离而缺氧,对其进行冷却可能影响冷却的组织中的血管收缩,等等。除了在血流受限期间由于缺氧造成的缺血性损伤和代谢废物在组织中的积聚之外,冷却治疗后的血流恢复还可能由于炎症和氧化损伤而对脂肪细胞产生再灌注损伤,氧化损伤已知在含氧血被恢复到已经经历了一段缺血期的组织中时发生。通过将脂肪细胞暴露于能量源(例如热,电,化学,机械,声学或其他手段)或以其它方式增加文中所述的冷却治疗期间或之后的血流速率,可加速这种类型的损伤。通过例如各种机械手段(例如施加压力或按摩)、化学手段或某些冷却条件增加这种脂肪细胞中的血管收缩,以及局部引入形成氧自由基的化合物以刺激脂肪组织中的炎症和/或白细胞活性,也有可能加速对这些细胞的损伤。其他尚未被理解的损伤机制可能存在。
除了富脂细胞死亡中涉及的凋亡机制之外,局部冷暴露也被认为诱导富脂细胞的脂解(即脂肪代谢),并且已经显示增强现有的脂解作用,其用于进一步提高皮下富脂细胞的减少,Vallerand,A.L.,Zamecnik.J.,Jones,P.J.H.,Jacobs,I."冷应激增加人的脂解、FFA Ra和TG/FFA循环(Cold Stress Increases Lipolysis,FFA Ra and TG/FFA Cyclingin Humans)"Aviation,Space and Environmental Medicine,70,42-50(1999)。
前述技术的一个预期优点是目标区域中的皮下富脂细胞通常可以减少而不会对相同区域中的非富脂细胞造成附带损伤。通常,富脂细胞可以在不影响非富脂细胞的低温下受到影响。结果,富脂细胞,例如与高度局部肥胖(例如颏下肥胖,下颌下肥胖,面部肥胖等)相关的那些细胞可受到影响,而在大致相同区域中的非富脂细胞(例如肌细胞)不会受到损坏。未受影响的非富脂细胞可以位于富脂细胞下(例如比皮下脂肪层更深的细胞),位于真皮中,位于表皮中和/或位于其他位置。
在一些过程中,治疗系统可通过组织的上层移除下层组织的热量,并产生最冷温度靠近冷却表面或施用器表面的热梯度(即,皮肤上层的温度可以低于目标下层细胞的温度)。将靶细胞的温度降低到足够低以破坏这些靶细胞(例如,诱导细胞凋亡,细胞死亡等)同时还将上层和表面皮肤细胞的温度保持足够高以形成保护(例如,非破坏性的),这是富有挑战性的。这两个阈值之间的温差可以很小(例如,约5℃至约10℃,小于10℃,小于15℃等)。在涉及持续暴露于低温的皮肤病学和相关美学疗程期间,保护覆盖细胞(例如,通常富含水的真皮和表皮皮肤细胞)免受冻伤可能包括通过以下方式改善这些皮肤细胞的耐冻性和/或避冻性:使用例如用于抑制或防止这种冻伤的冷冻保护剂。在至少一些情况下,粘合剂136充当这样的冷冻保护剂。当组织被冷却到高于组织的冻结点的温度时,当组织被冷却到低于组织的冻结点但由于过冷而不发生冻结的温度时,可以使用粘合剂,或者可替代地将粘合剂用于意图并导致发生组织冻结的过程中。关于与本发明的至少一些实施例相容的冷冻治疗的其他细节可以参见例如美国专利申请公开第2005/0251120号,其通过引用整体并入本文。
粘合剂制剂
根据本发明实施方式的粘合剂(例如,上述粘合剂136)可以包括当冷却时显著增加粘度和粘性(即,粘着性)的粘结剂(bonding agent)。粘合剂还可包括与粘结剂混合的降粘剂,以改变所得粘合剂的粘度温度依赖性,改变所得粘合剂的粘性温度依赖性和/或降低所得粘合剂的玻璃化转变温度。图23是纯粘结剂(右)和用降粘剂稀释的粘结剂(左)的粘度对温度的图。如图23所示,添加降粘剂降低了粘合剂的玻璃化转变温度,并且将粘合剂的高温依赖性粘度区域迁移到-20℃至20℃之间。在一些情况下,粘结剂在室温下为固体,并且降粘剂在室温下为液体溶剂,对粘结剂具有相对高的溶解度极限,例如大于50%w/w,60%w/w,70%w/w或更高的阈值。在其他情况下,降粘剂和粘结剂在室温下可以是可混溶的液体。
可以对粘合剂中粘结剂和降粘剂的相对比例进行选择,以产生冷却温度范围,在该冷却温度范围内粘合剂的粘度和粘性明显增加,相当于使用该粘合剂的治疗的冷却温度范围。例如,目标温度范围可以从施用温度(例如,室温或体温)延伸至冷却温度,该冷却温度适于破坏或以其他方式瓦解皮下富脂细胞和/或皮肤或皮下层中的任何其他目标结构(例如-20℃,-15℃,-10℃或-5℃)。粘合剂中粘结剂和降粘剂的相对比例可以额外或替代地基于粘结剂在降粘剂中的溶解度极限来进行选择。例如,粘合剂中粘结剂的浓度可以选择为在正常存储和使用粘合剂期间仍能充分抑制粘结剂的重结晶的最大浓度(由此使粘合剂的粘度和粘性最大化)。
依据本发明的至少一些实施方式的粘合剂在20℃的粘度小于500,000厘泊(例如在5,000厘泊到500,000厘泊的范围内),在-15℃的粘度大于3,000,000厘泊。在这些和其他情况下,在厘泊单位上,粘合剂在-10℃的粘度比粘合剂在20℃的粘度高至少1,000%(例如高至少3,000%,5,000%或10,000%)。此外,粘合剂可以在20℃具有对人皮肤的第一拉伸粘附力水平,并且在-10℃具有对人皮肤的第二拉伸粘附力水平,该第二拉伸粘附力水平比第一拉伸粘附力水平高不止1.25倍、1.5倍、2倍、3倍、4倍、5倍、6倍、7倍、10倍、20倍或30倍的倍数。这种对人皮肤的拉伸粘附力可以通过对设置在施用器和皮肤类似物之间的平面粘合剂层施加法向拉力来进行测试。
粘结剂可以是改性或未改性的糖。这些化合物可以很好地适用于这种应用,因为它们在冷却到高于其玻璃化转变温度的温度时往往变得越来越粘稠并粘性越来越强。如上所述,这种性质是冷却治疗过程中增强皮肤和施用器之间的粘附所希望的,该冷却治疗涉及使用施用器来冷却,由此破坏或以其他方式瓦解皮下富脂细胞和/或皮肤或皮下层中任何其他目标结构。皮肤与施用器之间的粘附强度可以受益于高粘度(例如,用于维持粘附的内部完整性)和高粘性(例如,用于维持粘合剂与皮肤之间的粘附界面的完整性)。糖也往往是生物相容、无毒和水溶性的,后者有助于促进清洁。适用于根据本发明的至少一些实施方式的方法的糖的例子包括改性和未改性的单糖(例如葡萄糖和果糖)以及改性和未改性的二糖(例如蔗糖,麦芽糖和海藻糖)。尽管以下描述了葡萄糖、果糖和乙酸异丁酸蔗糖酯(SAIB)的实验数据,但应当理解的是,其他改性和未改性的糖也预期适用于根据本发明实施方式的方法中。
糖和糖衍生物在冷却时变得越来越粘稠和粘性越来越强的倾向通常在其玻璃化转变温度以下不适用。例如,当纯SAIB、纯葡萄糖或纯果糖过渡到其玻璃态时,它变脆并且不再具有粘性。纯SAIB、纯葡萄糖和纯果糖的玻璃化转变温度都在0℃或以上。因此,如果在涉及冷却到0℃以下的冷却过程中以纯形式使用这些糖,则这些糖会转变为玻璃态,而冷却到0℃以下是破坏皮下富脂细胞的冷却过程中常用的。为了解决这个问题,粘结剂可以以一定的比例与降粘剂混合,该比例使所得粘合剂的玻璃化转变温度低于使用该粘合剂的冷却过程中的冷却温度特征。在至少一些情况下,以这种方式改变粘结剂的玻璃化转变温度,使得相应粘合剂的玻璃化转变温度低于-20℃,例如低于-30℃。合适的降粘剂包括二醇(例如丙二醇,二丙二醇和甘油)和其它极性的生物相容性油状化合物。这些化合物往往是糖的良好溶剂并且具有相对较低的玻璃化转变温度。
根据本发明的至少一些实施方式的粘合剂含有小于3%w/w的水。例如,根据本发明实施方式的粘结剂、降粘剂和粘合剂可以是无水的。水作为助溶剂存在往往降低降粘剂对改性或未改性糖的溶解度极限。因此,从包括糖基粘结剂的粘合剂中减少或消除水可增加这些粘合剂对其成分粘结剂的溶解度极限。这又可以增加粘合剂在冷却过程的目标温度范围内的最大粘度和粘性,同时在正常储存和使用粘合剂期间仍充分抑制粘结剂的重结晶。从包括糖基粘结剂的粘合剂中减少或消除水还可以增强粘合剂的抗微生物性质。在没有水的情况下,糖基粘结剂通常不支持细菌和真菌的生长。这可以促进包括这些粘结剂的粘合剂的制造和存储。
至少在某些情况下,希望粘合剂具有尽可能高的粘性。例如,除了具有足够高的冷却粘度以在冷却过程期间将施用器粘附到对象皮肤上之外,粘合剂还可以有利地具有足够高的施用粘度(例如在室温和/或在体温下)以便于在开始冷却之前或在实现显著冷却之前施加粘合剂。例如,高施用粘度可以抑制粘合剂的过度滴落和/或粘合剂从施用器与对象皮肤之间的界面挤出。相关地,粘合剂可以包括胶凝剂,其在应用时增强其保持其形状的能力。合适的胶凝剂的例子包括多糖(例如琼脂)和蛋白质(例如明胶)。胶凝剂可以以相对低的浓度(例如,低于5%w/w)存在,使得其存在不会过度地干扰粘合剂的其他所需性质。
作为减少或消除作为助溶剂的水的补充或替代,根据本发明的至少一些实施方式的粘合剂包括包含不止一种改性或未改性糖的粘结剂。例如,根据本发明的具体实施方式的粘合剂包括一种粘结剂,该粘结剂是改性或未改性的第一糖(例如,蔗糖、果糖和葡萄糖中的一种)与改性或未改性的第二糖(例如蔗糖、果糖和葡萄糖中的另一种)的组合。改性或未改性的第一糖和改性或未改性的第二糖均以相对于总粘结剂在5%w/w至95%w/w范围内的浓度存在。如同减少或消除水一样,在粘结剂中存在多于一种改性或未改性的糖可增加相应粘合剂对粘结剂的溶解度极限。根据本发明的具体实施方式的粘合剂包括包含改性或未改性果糖和改性或未改性葡萄糖的粘结剂。预期改性或未改性的糖的其他组合也适合用作粘结剂。
如上文关于嵌入式热传感器164(图11)所讨论的,在冷却过程期间检测与皮肤冻结有关的热信号可能是有用的。在至少一些情况下,根据本发明实施方式的粘合剂的热性质有助于该检测。例如,当粘合剂从施用温度(例如,室温或体温)冷却到适于破坏或以其他方式瓦解皮下富脂细胞和/或皮肤或皮下层中的任何其他目标结构的冷却温度(例如-20℃、-15℃、-10℃或-5℃)时,粘合剂的热导率可以增加。因此,当检测皮肤冻结的需求最大时,在冷却过程的最冷部分期间,粘合剂传输热信号的速率可以增加。此外,粘合剂的热导率可以在适于破坏或以其他方式瓦解皮下富脂细胞和/或皮肤或皮下层中的任何其他目标结构的冷却温度范围内(例如,范围从-5℃至-20℃)相对一致。例如,以瓦每米开尔文为单位,粘合剂在-5℃的热导率和粘合剂在-20°的热导率之间的差异可以小于2%。这对于在冷却过程期间促进与皮肤冻结相关的热信号和背景热信息的区分是有用的。
根据本发明实施方式的粘合剂还可以包括增加其热导率的添加剂。例如,给定的粘合剂可以包括高导热材料(例如氧化锌)的分散颗粒。可以通过超声或类似的混合过程将导热颗粒掺入粘合剂中以避免聚集。此外,粘合剂可以包括稳定剂(例如,相容的静电和/或空间稳定剂),其促进颗粒均匀分布在整个粘合剂中。因此,粘合剂在室温下可以是稳定的悬浮液。在一些情况下,颗粒被配置为在粘合剂中无规分布时增强粘合剂的导热性。在其他情况下,颗粒被配置为在粘合剂内有序分布时增强粘合剂的导热性。例如,根据本发明的具体实施方式的粘合剂中的导热颗粒被配置为就地磁性移位以增加粘合剂的导热性。与粘合剂一起使用的施用器可以被配置为施加磁场,该磁场导致颗粒形成通道,以在施用器与对象皮肤之间优先传递热能。根据本发明实施方式的这些和其他导热颗粒可以具有大于100纳米的平均有效直径,以在冷却过程期间减少或消除它们迁移通过对象皮肤。
根据本发明实施方式的粘合剂除了在冷却过程期间提供施用器与对象皮肤之间的粘附之外还可以具有益处。例如,一些粘合剂的降粘剂可以使潜在的冰核形成位点失活,由此抑制皮肤冻结。作为另一个例子,一些粘合剂的粘结剂可以吸收到对象皮肤中或者甚至穿过对象皮肤,并为非靶向细胞提供冷冻保护。类似地,当在对象皮肤上使用糖基预处理以进行冷冻保护时,在预处理之后施用的粘合剂中糖基粘结剂的存在可以建立浓度梯度,该浓度梯度抑制在预处理期间吸收的冷冻保护糖的向外迁移。作为上述优点的补充或替代,根据本发明实施方式的粘合剂还可以具有其它优点。
实验实施例
1.)粘度对浓度的依赖性(SAIB/DPG粘合剂)
包括乙酸异丁酸蔗糖酯(SAIB)和二丙二醇(DPG)的粘合剂通过在60℃混合这两种组分材料来制备。具体而言,制备具有70、75和80%v/v SAIB含量的SAIB/DPG粘合剂,并使用布氏(Brookfield)粘度计测量它们的粘度。下表1表明,通过向SAIB中加入DPG,可以调节混合物的粘度,在固定温度下越高的DPG含量导致越低的粘度。
表1:粘度对SAIB浓度的依赖性
SAIB%v/v | 粘度(cP) |
70 | 1700 |
75 | 2800 |
80 | 9500 |
2.)粘度对剪切速率的依赖性(SAIB/DPG粘合剂)
使用布氏粘度计测试包括70%v/v SAIB和30%v/v DPG的粘合剂的粘度以确定剪切速率依赖性。下表2中显示的结果表明测试的粘合剂是剪切速率依赖性的,因此可以模拟为非牛顿流体。
表2:粘度对剪切速率的依赖性
RPM | 粘度(cP) |
1.5 | 2050 |
3 | 2550 |
6 | 2780 |
12 | 2883 |
3.)粘度对温度的依赖性(SAIB/DPG粘合剂)
使用布氏粘度计测试包括70%v/v SAIB和30%v/v DPG的粘合剂的粘度以确定温度依赖性。图24中显示的结果表明,随着粘合剂温度从大约20℃降低到大约0℃,测试粘合剂的粘度增加了3个数量级。
4.)玻璃化转变温度(SAIB/DPG粘合剂)
对于不同SAIB浓度的SAIB/DPG粘合剂,观察相对于温度的玻璃化转变。下表3中显示的结果表明,包括80%v/v SAIB和20%v/v DPG的测试粘合剂能够在冷至-15℃的温度下支持冷却处理,并且包括70%v/v SAIB和30%v/v DPG的测试粘合剂能够在低至-20℃的温度下支持冷却处理。在表3中,Y=玻璃态,N=非玻璃态。
表3:SAIB/DPG的玻璃化转变
SAIB%v/v | 0℃ | -5℃ | -10℃ | -12.5℃ | -15℃ | -17.5℃ | -20℃ | -22.5℃ | -25℃ |
100 | Y | Y | Y | Y | Y | Y | Y | Y | Y |
90 | N | N | N | N | Y | Y | Y | Y | Y |
80 | N | N | N | N | N | Y | Y | Y | Y |
70 | N | N | N | N | N | N | N | Y | Y |
60 | N | N | N | N | N | N | N | N | N |
5.)冻结保护(SAIB/DPG粘合剂)
在-10℃的包括70%v/v SAIB和30%v/v DPG的粘合剂被发现在与-10℃下的过冷皮肤接触时不会引发即时的遵循指令的皮肤冻结。因此,通过在粘合剂存在下将皮肤冷却至-10℃并将组织保持在-10℃直至通过热相机检测到冻结来对测试粘合剂导致冻结的可能性进行测试。以这种方式检测到的冻结全部在皮肤内开始。这表明测试粘合剂在引发冻结中可能几乎没有任何作用。
6.)与非粘合性冷冻保护剂比较(SAIB/DPG粘合剂)
比较包括70%v/v SAIB和30%v/v DPG的粘合剂与非粘合性冷冻保护剂的自发皮肤冻结温度和热性质。测试的非粘合性冷冻保护剂是50%w/w丙二醇、1.5%w/w羟甲基纤维素和48.5%w/w水的混合物。在施用100μL测试粘合剂或非粘合性冷冻保护剂到治疗部位(1平方英寸)上之前,通过预处理皮肤擦拭物对待测试的皮肤进行清洁。使用包括以下步骤的温度设定点曲线施加冷却:首先从10℃降至-18℃,随后在约2.4分钟下降2℃,在约3.6分钟下降2℃,在约4.8分钟下降2℃,在约6.0分钟下降1℃,达到-25℃的温度。发现测试粘合剂和非粘合性冷冻保护剂分别对应于-22.79℃和-23.26℃的平均自发皮肤冻结温度。统计学测试(双尾T测试)给出p=0.93的p值,使用显著性水平α=0.05,表明测试粘合剂和非粘合性冷冻保护剂可能对应于相同的皮肤自发冻结温度。
还比较了测试粘合剂和非粘合性冷冻保护剂随时间变化的皮肤温度曲线。使用测试粘合剂和非粘合性冷冻保护剂以1.55℃/秒的升温速率和-18℃的目标温度进行测试处理。发现皮肤温度随时间变化的曲线以及达到目标温度的时间对于测试粘合剂和非粘合性冷冻保护剂大致相同。
7.)粘度对温度的依赖性(果糖/甘油粘合剂)
使用布氏粘度计测试包括43%w/w果糖和57%w/w甘油的粘合剂以确定温度依赖性。图25中显示的结果表明,随着粘合剂温度从大约80℃降低到接近0℃,粘合剂的粘度增加了几个数量级。对于零度以下的温度,粘合剂的粘度超出粘度计的可测范围。
8.)玻璃化转变温度(果糖/甘油粘合剂)
从理论和实验上确定包括43%w/w果糖和57%w/w甘油的粘合剂的玻璃化转变温度。如下所示的理论计算得到-45.082℃的玻璃化转变温度。
ω1=第一组分(果糖)的重量分数=0.571
ω2=第一组分(甘油)的重量分数=0.429
k=第一组分和第二组分之间的比热容比通过其玻璃化转变的变化=1.085/0.75
Tg1=第一组分(果糖)的玻璃化转变温度=7℃
Tg2=第二组分(甘油)的玻璃化转变温度=-93℃
通过差示扫描量热法(DSC)热分析进行粘合剂的玻璃化转变温度的实验测量。在DSC装置中,记录在相同温度下样品和参比样品的热流差异随温度的变化。这使得与相变相关的热效应(包括玻璃化转变)可以作为温度的函数测量。实验测量得到的测试粘合剂的玻璃化转变温度为-45.35℃,这与理论计算基本一致。
9.)拉伸粘附性(果糖/甘油粘合剂)
将加载有粘合剂(包括43%w/w果糖和57%w/w甘油)的人造丝布件设置在施用器和拉块之间。然后使用施用器将加载有粘合剂的布冷却至预定温度。在加载有粘合剂的布在预定温度下平衡之后,使用ESM303电动力测试仪(Mark-10,科菲亚格公司(Corporationof Copiague),纽约)以0.5英寸/分钟的恒定速度并且以0.25英寸的行进距离施加法向拉力。在拉块脱离之前记录峰值力。下表4中显示的结果表明,当粘合剂的温度从40℃下降到-22℃时,峰值拉伸粘附力从3.4lbF增加到34.3lbF。
表4:粘附对温度的依赖性
粘附力(lbF) | 温度(℃) |
3.4 | 40 |
7.0 | 25 |
15.5 | 10 |
21.3 | -2 |
27.0 | -12 |
34.3 | -22 |
10.)热性质(果糖/甘油粘合剂)
使用林赛斯瞬态热桥(Linseis Transient Hot Bridge,即THB)测试加载有包括43%w/w果糖和57%w/w甘油的粘合剂的织物件的热性质。THB能够测量在0.01至1W/mK范围内的热导率。使用冷却室来测量平衡时的温度依赖性质。测试粘合剂的密度假定为1.363g/cm3。该测试的结果显示在图26(比热和热导率对温度的图)和图27(热扩散率对温度的图)中。热数据显示,随着测试样品冷却,其作为导热层变得更有效。而且,热导率在0℃以下相对恒定。在低于0℃的温度下,热导率约为0.3W/(m·K),该值足够高,可以快速检测皮肤冻结释放的热量。
11.)玻璃化转变温度(葡萄糖/甘油粘合剂)
将加载有粘合剂(包括80%v/v的右旋糖当量为44的葡萄糖浆和20%v/v甘油)的一块纸巾放在施用器和500g重物之间。然后使用施用器以0.5℃/秒的冷却速率将加载有粘合剂的纸巾从10℃冷却至-10℃。在冷却之后和在-10℃保持3分钟之后,将施用器翻转,重物悬挂。通过该测试,发现加载有粘合剂的纸巾的拉伸强度足以防止重物由于重力作用而从施用器上脱离。
12.)在21.5℃的粘度(果糖/甘油粘合剂和果糖/葡萄糖/甘油粘合剂)
使用布氏粘度计测试具有三种不同配方的粘合剂在21.5℃的粘度。下表5中显示的结果表明,将总糖浓度从43%w/w增加至55%w/w明显提高了粘合剂在21.5℃的粘度。使用两种不同的糖(在该情况下为果糖和葡萄糖)都能获得这种增加,同时仍充分抑制糖的重结晶。
表5:在21.5℃的粘度
粘合剂 | 配方 | 粘度(cP) |
1 | 43%w/w果糖,57%w/w甘油 | 29,700 |
2 | 29%w/w果糖,14%w/w葡萄糖,57%w/w甘油 | 30,100 |
3 | 33%w/w果糖,22%w/w葡萄糖,45%w/w甘油 | 89,200 |
12.)热性质(果糖/葡萄糖/甘油粘合剂)
按照上述实施例10所述测试具有三种不同配方的粘合剂在-9.2℃、6.4℃和22.4℃的热导率。下表6中显示的结果表明,所有三种测试粘合剂具有足够的热导率以允许在冷却过程中进行冻结检测。
表6:在-9.2℃、6.4℃和22.4℃的热导率
13.)其他测试粘合剂
除了上面讨论的粘合剂配方之外,测试具有以下配方的粘合剂的温度依赖性粘附:(a)43%w/w果糖和57%w/w丙二醇,(b)43%w/w果糖和57%w/w二丙二醇,和(c)33%w/w葡萄糖和67%w/w甘油。发现这些粘合剂都具有类似于上述实施例9所述的包含43%w/w果糖和57%w/w甘油的粘合剂的温度依赖性粘附。
结论
上文描述了本发明的各实施方式。应当理解,提供前文所述的细节是为了用充分的方式描述实施方式以使相关技术领域的技术人员能进行并利用所公开的实施方式。但是,一些细节和优点对于实施一些实施方式可能不是必需的。此外,为避免不同实施方式的相关描述中不必要的混淆,一些公知的结构或功能可能未显示或未详细描述。虽然一些实施方式可以在本发明的范围内,但可能没有参照附图对它们进行详细描述。此外,不同实施方式的特征、结构或特点可以以任何合适的方式组合。而且,本领域技术人员了解有各种其它技术能用于进行与上述相似的功能。虽然以给定的顺序呈现过程或动作,但是替代实施方式可以以不同的顺序执行过程或动作,并且可以修改、删除和/或移动一些过程或动作。本文提供的标题仅为方便使用,不应理解为本发明的范围或含义。
除非说明书中另有明确说明,术语“包括”、“包含”等应被认为是包括性含义,而不是排他性或穷举性含义,也就是说,其含义是“包括但不限于”。使用单数或复数形式的用词还分别包括其复数或单数数量。当对两项或更多项的罗列使用“或”时,该词覆盖下列所有对其的解读:罗列中的任何项目、罗列中的所有项目和罗列中项目的任意组合。此外,短语“A,B和C等中的至少一个”意指本领域技术人员将理解该惯例的含义(例如,“具有A,B和C中的至少一个的系统”将包括但不限于具有单独的A,单独的B,单独的C,A和B一起,A和C一起,B和C一起,和/或A,B和C一起等)。在惯例类似于“A,B或C等中的至少一个”的那些情况下,一般而言,这样的构造意指本领域技术人员将理解该惯例的含义(例如,“具有A,B或C中的至少一个的系统”将包括但不限于以下系统:具有单独的A,单独的B,单独的C,A和B一起,A和C一起,B和C一起,和/或A,B和C一起等)。
任何专利、申请和其它参考文献,包括递交非所附文件中列出的任何文献均通过参考纳入本文。必要时所述发明的各方面可被修改,以应用上述不同参考文献中的各种系统、功能和概念来提供更多的实施方式。这些和其它的变化可以根据发明详述的提示作出。虽然上述说明提供了某些实施方式的细节,并描述了预期的最佳方式,可以进行不同的改变,不论改变如何细微。实施细节可以显著变化,但仍被本文所公开的发明所包含。如上所述,描述发明某些特征或方面时所用的具体术语不应理解为表示该术语在此被重新限定为局限于与该术语相关的本发明特定的特征、特点或方面。
Claims (15)
1.一种用于冷却具有皮肤的人对象的组织区域的系统,所述系统包括:
具有传热表面的施用器,其中所述施用器被构造为经由其传热表面冷却所述组织区域;和
粘合剂,所述粘合剂被配置为当所述施用器可操作地定位以冷却所述组织区域时所述粘合剂被设置在所述对象皮肤和所述施用器的传热表面之间,其中在所述粘合剂被设置在对象皮肤和所述施用器的传热表面之间时所述粘合剂从室温冷却至-10℃,由此将对象皮肤与施用器的传热表面之间的拉伸粘附力可逆地增加至少1.25倍。
2.如权利要求1所述的系统,其特征在于,在所述粘合剂被设置在对象皮肤和所述施用器的传热表面之间时冷却所述粘合剂,由此将对象皮肤与施用器的传热表面之间的拉伸粘附力可逆地增加至少2倍。
3.如权利要求1所述的系统,其特征在于,所述粘合剂的玻璃化转变温度低于-20℃。
4.如权利要求1所述的系统,其特征在于,冷却所述粘合剂包括将所述粘合剂冷却到低于-5℃的温度并保持至少15分钟。
5.如权利要求1所述的系统,其特征在于,冷却所述粘合剂包括将所述粘合剂冷却到在-20℃到-10℃范围内的温度。
6.如权利要求1所述的系统,其特征在于,冷却所述粘合剂包括将所述粘合剂冷却至不低于所述粘合剂的玻璃化转变温度的温度,其中冷却所述粘合剂将粘合剂的粘度在厘泊单位上增加至少1,000%。
7.如权利要求1所述的系统,其特征在于,冷却所述粘合剂包括将所述粘合剂冷却至不低于所述粘合剂的玻璃化转变温度的温度,其中冷却所述粘合剂将粘合剂的粘度在厘泊单位上增加至少10,000%。
8.如权利要求1所述的系统,其特征在于,冷却所述粘合剂包括将所述粘合剂冷却至从比粘合剂的玻璃化转变温度高1℃的温度到比粘合剂的玻璃化转变温度高10℃的温度的范围内的温度。
9.如权利要求1所述的系统,其特征在于,所述粘合剂被配置为在施用器被施加到对象皮肤之前并且在所述粘合剂的粘度在5,000至500,000厘泊范围内时将所述粘合剂施用于所述对象皮肤。
10.如权利要求2所述的系统,其特征在于,冷却所述粘合剂将所述粘合剂的粘度提高到以下范围内的粘度:从3,000,000厘泊到比粘合剂的玻璃化转变温度更高的温度下粘合剂的最大粘度。
11.如权利要求1所述的系统,其特征在于,所述施用器被配置为在冷却所述粘合剂之后经由所述传热表面加热所述粘合剂,以可逆地降低拉伸粘附力并由此促进对象皮肤与施用器的分离。
12.如权利要求1所述的系统,还包括配置为承载所述粘合剂的吸收性基材,其中所述施用器被配置为施加到对象皮肤上,使得所述吸收性基材位于所述施用器的传热表面和所述对象皮肤之间。
13.如权利要求1所述的系统,其特征在于,所述施用器限定三维腔,所述三维腔配置为接受对象皮肤,所述施用器被配置为至少部分地通过抽吸将皮肤推入所述三维腔中。
14.如权利要求1所述的系统,其特征在于,所述粘合剂包括胶凝剂,所述胶凝剂是多糖或蛋白质。
15.如权利要求1所述的系统,其特征在于,所述粘合剂在室温下是包括平均有效直径大于100纳米的导热颗粒的悬浮液,所述粘合剂中的颗粒被配置为响应于施加的磁场而移位,以增加所述粘合剂的热导率。
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US10524956B2 (en) | 2020-01-07 |
HK1259174A1 (zh) | 2019-11-29 |
AU2017206118B2 (en) | 2021-09-30 |
JP2019505349A (ja) | 2019-02-28 |
EP3399950A1 (en) | 2018-11-14 |
KR20220098285A (ko) | 2022-07-11 |
KR20180102600A (ko) | 2018-09-17 |
US20170196731A1 (en) | 2017-07-13 |
CN108472151A (zh) | 2018-08-31 |
JP6833869B2 (ja) | 2021-02-24 |
BR112018013919A2 (pt) | 2018-12-11 |
CA3009414A1 (en) | 2017-07-13 |
WO2017120538A1 (en) | 2017-07-13 |
US20200100935A1 (en) | 2020-04-02 |
KR102416368B1 (ko) | 2022-07-04 |
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