CN113828180A - 用于生产输送到患者体内组织的冷料浆的设备及方法 - Google Patents
用于生产输送到患者体内组织的冷料浆的设备及方法 Download PDFInfo
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- CN113828180A CN113828180A CN202111113883.3A CN202111113883A CN113828180A CN 113828180 A CN113828180 A CN 113828180A CN 202111113883 A CN202111113883 A CN 202111113883A CN 113828180 A CN113828180 A CN 113828180A
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Abstract
本发明涉及用于生产输送到患者体内组织的冷料浆的设备及方法。冷料浆可在装置内部本身或在单独的小腔室内产生,两种情况均使用冷却源和可注射流体产生冷料浆。输送装置通过装置内叶片的旋转和/或振动向流体/料浆提供持续的搅拌。通过使用外部冷却装置(例如冷却套管)来使流体/冷料浆冷却/保持冷却,该外部冷却装置至少部分包围输送装置。冷却套管可通过多种机构来冷却或维持冷料浆的温度。可使用本发明装置将冷料浆输送至体内的任何组织,包括皮下脂肪、内脏脂肪、和褐色脂肪。
Description
本申请是申请号为201780078680.0、申请日为2017年10月31日、发明名称为“用于料浆生成的装置和方法”的PCT国际发明专利申请的分案申请。
相关申请的交叉引用
本申请根据35 U.S.C.§119(e)要求2016年11月2日提交的美国临时申请系列号62/416484的权益,该临时申请的全部公开内容通过引用并入本文。
技术领域
本发明涉及一种用于生产输送到患者体内组织的冷料浆的设备及方法。
背景技术
减脂手术(通常被称为身体外形修整手术)的需求量很大,并且,尤其是随着越来越多的微创和无创疗法的出现而持续增加。根据美国美容整形外科学会(ASAPS)的数据,2014年,消费者在美容手术(包括有创、微创、和无创减脂手术)上的花费接近120亿美元。
市场上的有创减脂手术包括吸脂术、腹部成形术(“腹部收缩术”)、臀部成形术(臀部提升术)、臂部成形术(手臂提升术)、大腿成形术(大腿提升术)、下部皱纹切除术(颈部提升术)和颏部整形术(下巴收紧术)。有创疗法具有与外科手术相关的风险,其中一些可能危及生命。这些包括感染、疤痕、器官和血管穿孔、以及出血。此外,有创疗法往往伴随疼痛,通常需要很长的恢复期。
微创减脂手术包括激光辅助抽脂、激光脂肪溶解(即脂质分解)、射频脂肪溶解、超声脂肪溶解和注射脂肪溶解(如注射脱氧胆酸;KYBELLA)。这些手术可能需要手术切口和/或将化学制品输送到体内,这会给患者带来风险,而且通常伴随疼痛并且产生不均匀的结果。
目前市场上的无创手术包括使用射频、激光和超声波、以及将低温施加到皮肤表面(例如Zeltiq Aesthetics公司的冷冻溶脂)。这些疗法往往费时且痛苦,但效果甚微。
最近,已经开发出将冷质输送到脂肪组织的微创和无创手术,目前市场上有如上所述称为冷冻溶脂的无创疗法。这些手术基于这样的原则:脂肪细胞(脂肪组织)比皮肤或其它周围组织对寒冷的温度更敏感,寒冷的温度导致脂肪细胞凋亡,这是一个自然的生物过程,通过这个过程脂肪细胞被从身体中清除。
向皮肤无创输送低温会很痛苦,可能会产生不令人满意的结果,而且非常耗时,需要将相关设备长时间固定在患者皮肤上。相比之下,向皮下脂肪细胞(或深层至内脏脂肪组织)输送冷液体(如料浆)提供了一种用于有效且选择性地减少脂肪细胞的安全、可控的方法。国际申请公开号WO/2016/033380和美国申请公开号2013/0190744中公开了制备冷料浆及通过套管将冷液体输送到脂肪组织的方法,这两个公开的全部内容均并入本文。但是,需要一种冷料浆照护现场输送装置,其是方便的,要求少的维护及小的占地面积,并且对患者少的创伤。
发明内容
本发明提供了一种使用设备来产生冷料浆的方便的方式,该设备具有最少的部件且不需要大量设置、昂贵的维护、或冷藏运输/现场储存。本发明的设备和方法还提供了无需手术切口而有针对性地将冷料浆输送到脂肪细胞。
一般而言,本发明涉及一种用于制备和/或向人体输送冷料浆的小型设备。冷料浆可在装置内部本身或单独的小腔室内产生,这两种情况均使用冷却源和可注射流体在照护现场产生冷料浆。当冷料浆在单独的腔室中产生时,它随后可以很容易地转移到输送装置上,输送装置可以是注射器式装置。输送装置能够在照护现场为流体/料浆提供持续的搅拌,例如通过装置内叶片的旋转、使用振动或两者兼有。通过使用小型外部冷却装置(例如冷却套管)在输送装置内使流体/冷料浆冷却/保持冷却,该冷却装置至少部分围绕装置以在照护现场提供冷却。冷却套管可以通过多种机制冷却或维持冷料浆的温度,例如提供制冷剂、触发吸热反应、和压缩气体。可以使用本发明的设备将冷料浆输送到体内的任何脂肪组织,包括皮下脂肪、内脏脂肪、和褐色脂肪。例如,参见图1A和1B所示的皮下脂肪位置图以及腹部区域的皮下和内脏脂肪位置图。例如,冷料浆可输送至(例如但不限于)侧腹周围的脂肪组织(即“腰间赘肉”)、腹部、大腿区域、上臂、下巴下的颏下区域、眶下脂肪袋、膝盖上方以及任何其它需要减脂的皮下脂肪袋。
在某些实施方式中,本发明提供用于生产和/或输送冷料浆的设备。该设备包括圆柱形构件,该圆柱形构件包括第一端、第二端、和延伸穿过第一端和第二端的纵轴。该设备还包括沿纵轴在第一端和第二端之间延伸的外表面,以及由圆柱形构件的内壁限定的内腔。内腔配置为接收并保持冷料浆。该设备还包括至少部分地设置在内腔内并配置为沿纵轴方向在圆柱形构件内移动的柱塞。柱塞包括头部、插入构件、和杆,所述杆沿圆柱形构件的纵轴在头部和插入构件之间延伸。该设备还包括从圆柱形构件的第二端延伸的至少一个针和耦接到柱塞的搅拌装置。搅拌装置配置为在圆柱形构件的内腔内搅拌冷料浆。
该设备还可以包括与柱塞耦接的电机。电机可以耦接到头部和插入构件之间的杆。电机可以耦接到柱塞的头部。
搅拌装置可以包括从插入构件向圆柱形构件的第二端延伸的至少一个旋转叶片。搅拌装置配置为在柱塞旋转时搅拌冷料浆。搅拌装置可包括沿纵轴从插入构件向圆柱形构件的第二端延伸的导线。搅拌装置还可以包括从导线伸出并朝向圆柱形构件的内壁延伸的一个或多个触头。搅拌装置还可以包括耦接到柱塞并配置为使导线振动的电机。
圆柱形构件的外表面可以包括导电材料,例如铜。
该设备还可以包括围绕圆柱形构件的护套。护套可以包括导电材料,例如铜。
该设备还可以包括围绕圆柱形构件的至少一部分的冷却套管。冷却套管配置为冷却或维持圆柱形构件内腔内的冷料浆的温度。冷却套管和圆柱形构件可以同心设置,在冷却套管的内表面和圆柱形构件的外表面之间形成空间。
该设备还可以包括位于该空间内的至少一个管状构件。管状构件围绕圆柱形构件的外表面的圆周轴向地设置并至少部分地围绕圆柱形构件的外表面的圆周延伸。所述管状构件配置为包含冷却流体。管状构件可以是线圈形状。
该设备可进一步包括容器,所述容器围绕冷却套管的至少一部分并且在至少一个位置处流体连接到管状构件。所述容器配置为容纳冷却流体并向管状构件供应冷却流体。
冷却套管可进一步包括配置为与圆柱形构件的柱塞接合并使圆柱形构件的柱塞旋转的盖。
该设备可进一步包括围绕圆柱形构件的第一端的盖,所述盖配置为朝向所述圆柱形构件的第一端接纳冷却套管。在盖和冷却套管之间设有密封件。可在盖的内部空间内提供第一化学制品,可在圆柱形构件和冷却套管之间的空间内提供第二化学制品。在本实施方式中,密封件将第一化学制品与第二化学制品分离。当第一化学制品和第二化学制品混合在一起时发生吸热反应。第一化学制品和第二化学制品可从以下组中选择:水、氯化铵、硝酸钾、硫代硫酸钠、硝酸铵、硫氰酸铵、和八水氢氧化钡。
在一些实施方式中,圆柱形构件和冷却套管之间的空间可以形成腔室。围绕冷却套管的至少一部分的容器流体连接到所述腔室。所述容器配置为容纳冷却流体并向所述腔室供应冷却流体。位于腔室和容器之间的至少一个入口配置为允许冷却流体从容器流入腔室中。所述至少一个入口可操作地耦接到释放机构,以控制冷却流体通过所述入口的流动。
所述设备可进一步包括设置在腔室和圆柱形构件的外表面之间的导电膜。圆柱形构件的外表面可以包括导电材料。导电膜和导电材料可以配置为在圆柱形构件被容纳在冷却套管内时彼此相互作用。
在某些实施方式中,该设备包括设置在冷却套管内表面和圆柱形构件外表面之间的空间内的至少一个腔室。所述至少一个腔室沿平行于圆柱形构件的纵轴的第二轴延伸,并且被配置为容纳流体。该设备进一步包括配置为压缩至少一个腔室中的流体的加压气体源。所述至少一个腔室可以包括第二柱塞,所述第二柱塞配置为在被加压气体源激活时压缩所述流体。所述面对圆柱形构件的至少一个腔室的壁的至少一部分可以包括导电膜。
该设备可以包括配置为将冷料浆可拆卸地耦接并供应到圆柱形构件的内腔的腔室。所述腔室可以包括顶端和底端。顶端包括与位于圆柱形构件第二端的第二连接器相匹配的第一连接器。第一连接器和第二连接器配置为在匹配时允许冷料浆从腔室流入内腔。
所述腔室可以配置为使用冷却可注射流体的冷却流体来产生冷料浆。所述腔室可包括位于所述腔室的顶端并配置为容纳可注射流体的第一隔室、位于所述腔室的顶端和底端之间的第二隔室、以及位于所述腔室的底端并配置为容纳冷却流体的第三隔室。第二隔室可以配置为包含盐水填充颗粒。第一隔室和第二隔室可以通过分离构件彼此分离。分离构件可以是易碎裂的密封件,该密封件配置为破裂以使得第二隔室的内容物与第一隔室中的可注射流体混合。
在一些实施方式中,第二隔室和第三隔室通过一个或多个阀彼此流体连通。一个或多个阀配置为当被打开时将第三隔室中的冷却流体释放到第二隔室中。
在其它实施方式中,本发明提供一种用于生产用于输送到患者体内组织的冷料浆的设备。所述设备包括含有可注射流体的第一隔室、第二隔室、和含有冷却流体的第三隔室,所述第三隔室用于冷却可注射流体。第二隔室可以包括多个颗粒,在一些实施方式中,这些颗粒可以是多个盐水填充颗粒。第一隔室和第二隔室可以通过分离构件彼此分离。分离构件可以是易碎的密封件,该密封件配置为破裂以使得第二隔室的内容物与第一隔室中的可注射流体混合。第二隔室和第三隔室可以通过一个或多个释放机构流体连通。释放机构配置为在被触发时将第三隔室中的冷却流体释放到第二隔室中。
在某些实施方式中,本发明提供一种使用输送装置产生冷料浆的方法。该方法包括向输送装置的圆柱形构件的内腔提供流体,使用搅拌置搅拌内腔中的流体,并使用外部冷却装置冷却内腔中的流体以生成冷料浆。外部冷却装置至少部分地围绕输送装置的圆柱形构件。流体的搅拌和冷却可以同时进行。外部冷却装置可以是围绕输送装置的圆柱形构件的至少一部分的冷却套管。搅拌装置可以包括耦接到柱塞的一个或多个旋转叶片,柱塞至少部分地设置在输送装置的圆柱形构件的内腔中。搅拌装置可以包括振动机构。
在一些实施方式中,所述方法进一步包括使用至少部分设置在输送装置的圆柱形构件的内腔中的柱塞将冷料浆从输送装置喷射出来。喷射的冷料浆可以输送到一种或多种组织类型,所述组织类型选自由皮下脂肪、内脏脂肪、和褐色脂肪构成的群组。喷射的冷料浆可以输送到一个或多个区域的组织周围所述一个或多个区域选自由以下构成的群组:侧腹周围组织、腹部、大腿区域、上臂、下巴下的颏下区域、眶下脂肪袋、膝盖上方、以及任何其它需要减脂的皮下脂肪袋。
在某些实施方式中,本发明提供了一种使用料浆生成腔室生成冷料浆的方法。该方法包括提供料浆生成腔室,其包括:包含可注射流体的第一隔室、第二隔室、和包含冷却流体的第三隔室。该方法进一步包括将冷却流体从第三隔室释放到第二隔室中,以冷却第一隔室中的可注射流体并生成冷料浆。第二隔室可以包括多个颗粒,所述多个颗粒配置为在生成冷料浆时搅拌可注射流体。该方法可进一步包括在将却流体从第三隔室释放到第二隔室之后,将第二隔室的内容物释放到第一隔室。该方法可进一步包括向料浆生成腔室提供搅拌,例如摇动料浆生成腔室。
附图说明
图1A是体内皮下脂肪位置的示意图。
图1B是腹部区域内皮下和内脏脂肪位置的示意图。
图1C是体内褐色脂肪位置的示意图。
图2显示了示例性冷料浆输送装置的侧视图。
图3显示了根据本发明的实施方式具有搅拌装置的冷料浆输送设备的透视图,而图3A和3B描绘了根据图3的实施方式的设备内冷料浆的移动。图3C显示了示例性冷料浆输送装置的单个针阵列的侧视图。
图4A和4B描绘了实现旋转的电机的放置的不同实施方式。
图5显示了根据本发明的另一实施方式具有搅拌装置的冷料浆输送设备的透视图。
图6描绘了在其外表面上具有导电材料的冷料浆输送设备,图6A描绘了所述设备的壁的横截面,显示嵌入在壁中的导电材料。
图7描绘了根据本发明实施方式的带有冷却套管的冷料浆输送设备的横截面透视图。
图8描绘了根据本发明另一实施方式的带有冷却套管的冷料浆输送设备的横截面透视图。
图9描绘了根据本发明另一个实施方式的带有冷却套管的冷料浆输送设备的横截面分解透视图,图9A描绘了沿线9A截取的俯视截面图。
图10描绘了根据本发明另一实施方式的带有冷却套管的冷料浆输送设备的横截面透视图。
图11A和11B描绘了通过使用柱塞对冷料浆输送装置中所含流体产生负压。
图12描绘了根据本发明实施方式的料浆生成腔室的横截面透视图,图12A显示了图12所示的固体盐水填充球体的近视图。
图13描绘了根据本发明的实施方式将冷料浆从冷料浆生成腔室转移到冷料浆输送设备,图13A描绘了图13的阳性连接器和阴性连接器的近视图。
图14描绘了使用本发明的设备将冷料浆输送到皮下组织。
具体实施方式
本发明涉及使用小型设备制备冷料浆并将其输送至人体。冷料浆可以在输送装置本身中产生,或者可以在单独的腔室中产生并从该腔室输送。产生料浆的两种方法都包括使用可注射流体、冷却源、和某种形式的搅拌。当使用单独的腔室时,通过将(例如)冷却源(例如制冷剂)、可注射流体、和可选固体盐水源在腔室内组合而产生料浆。当使用冷料浆输送装置产生冷料浆时,通过对可注射流体在装置内进行外部冷却而产生料浆。外部冷却装置的例子是冷却套管,其冷却装置内的流体或保持输送至装置的冷料浆的温度。冷却套管可以通过多种机制冷却或维持冷料浆的温度,例如提供制冷剂、触发吸热反应、及压缩气体。冷料浆输送装置和单独的腔室都能够向流体/料浆提供持续的搅拌,例如通过装置内叶片的旋转、振动的使用、或两者兼有。流体/料浆通过使用外部冷却(如容易滑过装置并提供冷却的冷却套管)而在冷料浆装置内冷却/保持冷却。可以使用本发明的设备将冷料浆输送到体内的任何脂肪组织,包括皮下脂肪、内脏脂肪、和褐色脂肪。例如,但不限于,冷料浆可以输送到图1A-C所示的任何区域中的脂肪组织,所述任何区域例如侧腹周围(即“腰间赘肉”)、腹部、大腿区域、上臂、下巴下的颏下区域、眶下脂肪袋、膝盖上方以及图中所示的其它区域。原则上,冷料浆可以输送到任何需要减脂的皮下脂肪袋中。
在一个实施方式中,冷料浆在冷料浆输送装置内产生。所述料浆是通过向所述冷料浆输送装置提供流体并在提供搅拌的同时在所述装置内冷却所述流体而产生的。提供至冷料浆输送装置的流体可以是任何能够被冷却以提供冷料浆的无菌、生物相容的流体。或者,可在单独的腔室中生产冷料浆后再将其提供至输送装置。优选地,将流体温度冷却至或低于约10℃、7℃、5℃、4℃、3℃、2℃、1℃、0℃、-1℃、-2℃、-3℃、-4℃、-5℃、-10℃、-15℃、-20℃、-30℃、-40℃、及-50℃。所产生的冷料浆将具有多个无菌冰颗粒,并且适于注射到受试者体内。国际申请公开号WO/2016/033380提供了示例性料浆组成成分、料浆温度、及冰颗粒的横截面尺寸,该国际公开整体并入本文。应当理解,根据本发明的冷料浆的优点是:冷料浆的组成适合输送到患者体内的组织并留在体内(例如,实现冷却后不需要去除料浆)。
在一个实施方式中,流体含有一种或多种冰点抑制剂,这些抑制剂抑制流体的冰点、干扰水分子之间的结合、防止冰颗粒凝聚、改变流体的粘度或以其它方式影响流体的性能。国际申请公开号WO/2016/033380提供了示例性冰点抑制剂,该公开整体并入本文中,包括盐(例如氯化钠)、离子、乳酸林格溶液、糖(例如葡萄糖、山梨糖醇、甘露醇、羟乙基淀粉、蔗糖、或其组合)、例如甘油的生物相容性表面活性剂、其它多元醇、其它糖醇、和/或尿素等。一方面,流体的冰点抑制剂含量在约5%到约40%之间、约10%到约30%之间、或约12%到约22%之间。在优选实施方式中,所述流体包括生物相容性表面活性剂,例如甘油。这些成分被认为会导致冰颗粒收缩并变得更圆。这些成分也可以作为非富脂细胞的低温保护剂。
为了产生选择性破坏富脂细胞同时避免急性非选择性坏死的冷料浆,该料浆优选与受试者的细胞等渗,例如具有约308mOsm/L的渗透压。示例性冷料浆组成包括生理盐水和20%的甘油。在非选择性、更广泛的破坏性料浆中,可通过增加溶质浓度(例如,至20%w/v盐水)形成高渗溶液(即渗透压大于约308mOsm/L的溶液),从而达到更冷的温度和更大的破坏力,该高渗溶液还会通过渗透压破坏细胞。结果表明,随着冰的融化,溶质的浓度会降低。还预期冷料浆可进一步包括治疗性化合物。
此外,国际申请公开号WO/2016/033380(其通过引用并入本文中)公开了由初始流体产生的冷料浆可具有不同的含冰量。例如但不限于,冷料浆可含有约0.1重量%至约75重量%的冰、约0.1重量%至约1重量%的冰、约1重量%至10重量%的冰、约10重量%至约20重量%的冰、约20重量%至约30重量%的冰、约30重量%至约40重量%的冰、约40重量%至约50重量%的冰、约50重量%至约60重量%的冰、约60重量%至约70重量%的冰、大于约50重量%的冰。(由于固态和液态水的密度,冰的体积比例稍高。)
无菌冰颗粒的最大横截面尺寸可小于约2mm、约1.75mm、约1.5mm、约1.25mm、约1mm、约0.9mm、约0.8mm、约0.7mm、约0.6mm、约0.5mm、约0.4mm、约0.3mm、约0.2mm或约0.1mm。
流体可含有其它赋形剂,例如Sougata Pramanick等人的“Excipient SelectionIn Parenteral Formulation Development”(肠外配方开发中的赋形剂选择),Pharmatimes(制药时报),(2013)45(3),65-77页以及国际申请公开号WO/2016/033380中所发现的赋形剂,两者均通过引用并入本文。示例性赋形剂包括膨松剂,例如蔗糖、乳糖、海藻糖、甘露糖醇、山梨糖醇、葡萄糖、棉子糖、甘氨酸、组氨酸、PVP(K40);缓冲剂,例如柠檬酸钠、磷酸钠、氢氧化钠、tris碱-65、tris醋酸盐、tris HCl-65;张力调节剂,例如葡萄糖;坍塌温度调节剂,例如右旋糖酐、聚蔗糖、明胶、和羟乙基淀粉;抗菌防腐剂,如苯扎氯铵、苄索氯铵、苄醇、氯丁醇、间甲酚、十四烷基吡啶铵、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、苯酚、2-苯氧基乙醇、苯基硝酸汞、和硫柳汞;螯合剂,例如EDTA二钠钙(乙二胺四乙酸)、EDTA二钠、Versetamide钠钙、钙立醇、和DTPA;抗氧化剂和还原剂,例如丙酮硫酸氢钠、氩、抗坏血酸棕榈酸酯、抗坏血酸(钠/酸)、亚硫酸氢钠、丁基羟基茴香醚、丁基羟基甲苯(BHT)、半胱氨酸/半胱氨酸盐酸盐、连二亚硫酸钠、龙胆酸、龙胆酸乙醇胺、谷氨酸单钠、谷胱甘肽、甲醛合次硫酸氢钠、焦亚硫酸钾、焦亚硫酸钠、蛋氨酸、单硫代甘油(硫代甘油)、氮、没食子酸丙酯、亚硫酸钠、生育酚α、α-生育酚琥珀酸氢、巯基乙酸钠、硫脲、和无水氯化亚锡;溶剂和共溶剂,例如苯甲酸苄酯、油、蓖麻油、棉籽油、N,N二甲基乙酰胺、乙醇、脱水乙醇、甘油/丙三醇、N-甲基-2-吡咯烷酮、花生油、PEG、PEG 300、PEG 400、PEG 600、PEG 3350、PEG 4000、罂粟籽油、丙二醇、红花油、芝麻油、大豆油、植物油、油酸、聚氧乙烯蓖麻、无水乙酸钠、无水碳酸钠、三乙醇胺、和脱氧胆酸盐;缓冲剂和pH调节剂,例如乙酸盐、硫酸铵、氢氧化铵、精氨酸、天冬氨酸、苯磺酸、苯甲酸钠/酸、碳酸氢钠、硼酸/钠、碳酸盐/钠、二氧化碳、柠檬酸盐、二乙醇胺、葡萄糖酸-δ内酯、甘氨酸/甘氨酸盐酸盐、组氨酸/组氨酸盐酸盐、盐酸、氢溴酸、赖氨酸(L)、马来酸、葡甲胺、甲磺酸、单乙醇胺、磷酸盐(酸、一元钾、二元钾、一元钠、二元钠、和三元钠)、氢氧化钠、琥珀酸钠/二钠、硫酸、酒石酸钠/酸、和氨丁三醇(Tris);稳定剂,例如氨基乙基磺酸、无菌碳酸氢钠、L-半胱氨酸、二乙醇胺、二亚乙基三胺五乙酸、氯化铁、白蛋白、水解明胶、insitol、D,L-甲硫氨酸;表面活性剂,例如聚氧乙烯山梨醇酐单油酸酯(80)、山梨醇酐单油酸酯、聚氧乙烯山梨醇酐单月桂酸酯(20)、卵磷脂、聚氧乙烯-聚氧丙烯共聚物聚氧乙烯单月桂酸酯、磷脂酰胆碱、甘油脂肪酸酯、尿素;络合剂/分散剂,例如环糊精(例如羟丙基-B-环糊精、磺丁基醚-环糊精);以及增粘剂,例如羧甲基纤维素钠、阿拉伯胶、明胶、甲基纤维素、聚乙烯和吡咯烷酮。
产生和/或输送料浆的装置100大体如图2所示。输送装置100包括具有第一(近)端112、第二(远)端114的圆柱形构件110;延伸穿过第一端112和第二端114的纵轴Y;以及沿纵轴Y在第一端112和第二端114之间延伸的外表面116。输送装置100还包括由圆柱形构件110的内壁限定的内腔130。内腔130接收并保存要冷却的流体以及最终的冷料浆。圆柱形构件110还包括凸耳150或“臂”,其沿与纵轴Y正交的平面围绕第一端112从圆柱形构件110延伸而出。凸耳150还具有与内腔130同心的开口。凸耳150有助于从输送装置100处理和输送流体/料浆,也有助于将输送装置100固定在冷却套管内,后者在下文中更详细地描述。
在一个实施方式中,输送装置100是注射器型装置,例如91-3型注射器。圆柱形构件110可由任何类型的生物相容性药物惰性材料制成,该材料适用于保持和供应向人体内提供的流体。圆柱形构件110的示例性材料包括塑料(例如聚乙烯或聚丙烯)和玻璃。输送装置100可以是适合容纳一个或多个小份或剂量的冷料浆的任何尺寸,用以将其输送到所需组织。输送装置100的体积容量通常在1ml到60ml之间,尽管也考虑这些体积之外的容量。
输送装置100还包括至少部分设置在内腔130内的柱塞120。柱塞120配置为沿输送装置100的纵轴Y通过第一端112进出圆柱形构件110。柱塞120包括头部122、插入构件124、和杆126。杆126沿输送装置100的纵轴Y在头部122和插入构件124之间延伸。插入构件124设置在距头部122预定距离处。输送装置100还包括从第二端114延伸的至少一个针140。针140的厚度通常在7Ga.(gauge)和34Ga.之间,长度在1/4”和10”之间,例如约1/4”、1/2”、1”、2”、3”、4”、5”、6”、7”、8”、9”、或10”。在一个实施方式中,圆柱形构件110在第二端114处变窄或逐渐变细为小开口。小开口配置为接收针140。优选地,针140是皮下注射针。示例性针的材料包括但不限于有或无镀镍的不锈钢和碳钢。
为了使流体通过针140而不被卡住或阻塞冷料浆的流动,冰颗粒的最大横截面必须小于针140的内径。例如,该最大横截面可以小于内径的约95%,小于内径的约85%,小于内径的约75%,小于内径的约65%,小于内径的约55%,并且优选约为内径的50%。下表提供了美国专利申请公开号2017/0274011所公开的各种内径所适合的示例性冰颗粒尺寸,该专利申请整体并入本文。应当理解的是,这些颗粒尺寸只是为了示范而不是为了限制。
返回到图2所示的冷料浆输送装置100,柱塞120(包括头部122和杆126)可以是任何类型的生物相容性、药理学惰性材料,适于接触将提供给人体内的流体。柱塞120的示例性材料包括塑料(例如聚乙烯或聚丙烯)以及玻璃。对于插入构件124,一部分或整个插入构件124可以是橡胶材料,使得在插入构件124的侧面和圆柱形构件110的内壁之间形成密封。橡胶材料可以是适于接触将提供给人体的流体的任何橡胶,例如天然橡胶乳胶或合成橡胶。
在内腔130内产生冷料浆的过程中,柱塞130基本保持在静止位置,其中插入构件124朝向圆柱形构件110的第一(近)端112,流体保持在插入构件124和第二(远)端114之间。在一些方面,柱塞120可以通过圆柱形构件110向上移动,使得插入构件124朝向输送装置100的第一端112移动。这样的移动对流体产生负压,从而降低流体的凝固点。
一旦冷料浆产生并准备使用输送装置100输送到组织,针140被用来刺穿病人的皮肤。一旦针140穿过皮肤并定位在目标组织处或其附近,柱塞120被迫向下朝向圆柱形构件110的第二端114移动。插入构件作用在冷料浆上的力与冷料浆压力的增加迫使冷料浆通过圆柱形构件110并从针140进入组织。在一个方面,在冷料浆输送装置100的第二端114处提供过滤器,以帮助控制使用装置100输送的料浆冰颗粒的粒径。
在一个实施方式中,在输送装置100的第二端114处提供一个以上的针,如图3C所示。该一个以上的针可提供在单列阵列(如图所示)、多列阵列(未示出)、圆形图案(未示出)、或任何其它方便的设置中。
为了在流体冷却时促进冷料浆的形成,和/或在冷料浆形成时防止无菌冰颗粒聚集,在圆柱形构件110内提供搅拌。在一个实施方式中,通过一个或多个叶片210和耦接到柱塞的可选支撑构件215的旋转来提供搅拌,如图3所示。在一个实施方式中,叶片210是允许流体在叶片210和支撑构件215之间流动的条带。在一个方面,一个或多个叶片210可以相互交叉以沿纵轴形成数字8或类似的图案。在另一实施方式中,一个或多个叶片210在结构上是实心的,并且从支撑构件215朝向圆柱形构件110的内壁延伸,使得流体不能在支撑构件215和叶片210之间流动。叶片210可以沿平面从支撑构件215延伸出来,其中该平面的一个维度由冷料浆输送装置100的纵轴Y限定。可选地,叶片210可以沿与纵轴成一定角度相交的平面从支撑构件215延伸出来。叶片210可以由任何适于与待输送到人体的无菌组合物接触的材料制成,包括先前关于圆柱形构件110、柱塞120、和针140提供的那些示例性材料。
在一个实施方式中,柱塞120的旋转导致叶片210旋转,这反过来导致流体/浆料在多个方向上流动,如图3A和3B所示。在一个实施方式中,通过使用手或曲柄转动柱塞头部122,手动完成柱塞120的旋转。在另一个实施方式中,借助电机220来辅助旋转。电机可以在任意数量的位置耦接到冷料浆输送装置100。例如,在一个实施方式中,电机220沿杆126耦接到柱塞120,如图4A所示,杆126用作齿轮。在一个方面,电机220在头部122和插入构件124之间耦接到杆126。在图4B所示的另一个实施方式中,电机220通过柱塞头部122耦接到柱塞120上,柱塞头部122用作齿轮。在另一方面中,叶片210是可折叠的和/或柔性的,使得当力施加到柱塞120上且插入构件124向第二端114移动时,叶片210塌陷,从而允许柱塞120穿过圆柱形构件110行进,并迫使冷料浆离开冷料浆输送装置100。
在另一个实施方式中,如图5所示,通过使用振动提供搅拌。在该实施方式中,导线410沿冷料浆输送装置100的纵轴Y从插入构件124向圆柱形构件110的第二端114延伸。通过耦接到柱塞120的电机420(例如电池供电的振动电机)向导线410提供振动。当振动被提供给导线410时,导线410在多个方向上移动(如图中箭头所示)以向流体/料浆提供搅拌。在一个方面,可以沿导线410提供一个或多个导线触头415,该一个或多个导线触头从导线410伸出来并朝向圆柱形构件110的内壁延伸。触头415提供额外的振动和运动。类似于在冷料浆输送装置100内提供的其它部件,导线410和触头415可以由生物相容性和药理学惰性的任何材料制成。
应该理解的是,本领域已知的任何搅拌流体的方式都可以用来在冷料浆产生过程中提供搅拌。
为了实现将热从冷料浆转移/将冷转移到冷料浆,冷料浆输送装置100可以设置有导电材料。在一个实施方式中,如图6和6A所示,导电材料510被提供到冷料浆输送装置100的外表面116。导电材料510可以通过围绕圆柱形构件110的外表面116的护套520提供到外表面116。在一个方面,导电材料作为嵌入件提供在护套520的外表面上。嵌入件可以围绕护套520设置,使得嵌入件不在护套壁的整个深度延伸,如图6A所示。
可选地或另外地,圆柱形构件110本身包括导电材料510。在一个方面,导电材料510设置在圆柱形构件110的整个壁上。在另一方面,导电材料510作为嵌入件提供在圆柱形构件110的外表面116。在又一方面,导电材料510被提供到圆柱形构件110,使得嵌入件与圆柱形构件110的内腔130中包含的流体接触。
导电材料510可以是任何能够实现热传递的材料。示例性导电材料包括但不限于银、铜、金、铝、黄铜、锌、镍、铁、锡、磷青铜、钢、和铅。在优选实施方式中,导电材料510包括铜。
导电材料510可提供在护套520和/或圆柱形构件110约5%到约95%的表面上,例如约5%、10%、15%、20%、25%、30%、40%、50%、60%、70%、75%、80%、90%、95%、100%或之间的其它百分比。在一个方面,导电材料510被提供为围绕护套520和/或圆柱形构件110缠绕的条带。然而,应当了解,导电材料可以任何方式设置在护套/圆柱形构件110上。
在图7所示的本发明的一个实施方式中,所述设备还包括冷却套管600,该冷却套管600围绕圆柱形构件110,并且内冷却或保持内腔130内的冷料浆的温度。冷却套管600可通过任何数量的机制提供冷却,例如通过使用循环制冷剂、使用吸热反应、和使用压力。
冷却套管600与圆柱形构件110的外表面116同心,并与外表面116隔开,从而在冷却套管600和圆柱形构件110之间形成空间612。在一个实施方式中,冷却套管600配置为提供用于接收冷料浆输送装置100的内部腔室640。在一个方面,冷却套管600具有底部604和顶部602,底部604在圆柱形构件110的第二端114的下方延伸,顶部602在圆柱形构件110的第一端112和柱塞头部122的上方延伸,使得冷却套管600将冷料浆输送装置100整体包围,如图7所示。冷却套管600的顶部602处设有可拆卸盖614,以允许将冷料浆输送装置100插入并随后封闭在冷却套管600内。与冷料浆输送装置100的部件类似,冷却套管600可由任何生物相容性和药理学惰性材料制成。但是,由于冷却套管600可以不与冷料浆输送装置100内的流体接触,因此可以使用其它材料。
在使用旋转来搅拌冷料浆输送装置100内流体的一个实施方式中,电机620和相关联的齿轮可以设置在/耦接到装置100上,例如设置在/耦接到先前公开并如图7所示的柱塞头部122或杆126上。电机620和相关联的齿轮也可以设置在/耦接到冷却套管100上,例如沿纵轴设置在盖614上或围绕盖614的顶部边缘设置,边缘设置有齿轮齿,如图7所示。电机620也可在圆柱形构件110第二端114处设置在/耦接到冷却套管600上。还应理解,电机620和相关联的齿轮可设置在冷料浆输送装置100或冷却套管600内或其上的任何其它位置,该位置便于旋转且不限于上述示例,并且齿轮齿可位于冷却套管600和冷料浆输送装置100中的一个或两个的内部或外部。
在使用循环制冷剂通过冷却套管600实现冷却的一个实施方式中,在冷却套管600和圆柱形构件110之间的空间612内提供至少一个管状构件650,如图7所示。管状构件650围绕圆柱形构件110的外表面116轴向设置,管状构件650至少部分地围绕外表面116的圆周延伸。在优选实施方式中,管状构件650缠绕在圆柱形构件110周围以形成线圈。管状构件650是中空的,以允许冷却流体流过其内部。
在一个方面,将冷却流体供应单元630提供给冷却套管600,用于向冷却套管600供应冷却流体。在一个实施方式中,冷却流体供应单元630围绕冷却流体供应单元630的至少一部分,包括冷却套管600的底部604,如图7所示。冷却流体供应单元630流体连接到管状构件650,以便向管状构件650供应冷却流体。在一个实施方式中,冷却流体供应单元630类似于电路冷却器,其在按下触发器时提供冷却流体流。
冷却流体可以是能够提供冷却的任何流体。在一个实施方式中,冷却流体是市售的制冷剂,例如氨(R717)、HCF(134a/R-134a)、CO2(R-744)、以及HFO-1234yf(2,3,3,3-四氟丙烯)或其它,例如R404A、R407A、R744、R290、和R410A。在另一个实施方式中,冷却流体是液氮。
冷却套管600还可以通过吸热反应提供冷却,如图8所示。在该实施方式中,在冷却套管600的盖614的内部空间内提供第一化学制品660,在冷却套管600和圆柱形构件110(未显示)之间的空间612内提供第二化学制品665。
选择第一和第二化学制品660和665,使得冷却套管600和圆柱形构件110的外表面116之间的空间612内的两种化学制品的混合物产生吸热反应,从而为腔室640内的冷料浆输送装置提供冷却。产生吸热反应的化学制品的示例性组合包括但不限于:硫氰酸铵和八水氢氧化钡;水和硫代硫酸钠;水和氯化铵;水和硝酸铵;以及水和硝酸钾。
在盖614和冷却套管600的其余部分之间提供密封件618,以使第一化学制品660和第二化学制品665在需要冷却时才相互混合。密封件618可以通过本领域已知的任何方式破裂,例如通过拧动盖614而使密封件618破裂。一旦密封件618破裂,第一化学制品660从盖614释放,进入空间612,并与第二化学制品665混合,以提供吸热反应。
冷却套管600还可以通过使用冷却流体提供冷却,该冷却流体通过圆柱形构件110和冷却套管600之间的空间612循环,如图9所示。在该实施方式中,空间612形成用于保持和使流体(优选冷却流体)循环的腔室。
与图7所示的实施方式类似,所述冷却流体可以是能够提供冷却的任何流体。在一个实施方式中,冷却流体是市售的制冷剂,例如氨(R717)、HCF(134a/R-134a)、CO2(R-744)、以及HFO-1234yf(2,3,3,3-四氟丙烯)或其它,例如R404A、R407A、R744、R290、和R410A。在另一个实施方式中,冷却流体是液氮。
在一个方面,冷却流体通过冷却流体供应单元630提供给冷却套管600,冷却流体供应单元630围绕冷却套管600的至少一部分。冷却流体可通过一个或多个入口670(或阀)从容器释放到空间612。入口670保持关闭,直到被释放机构680发出的信号触发。一旦被信号触发,一个或多个入口670将打开,允许来自冷却流体供应单元630的冷却流体通过并进入空间612。流体沿平行于纵轴的方向(如图9所示)以及沿圆周方向流过空间612,如俯视截面图9A所示,该图沿线9A截取。
在另一方面,在空间612和腔室640之间提供导电膜618,如图9A所示,使得导电膜618与至少在冷料浆输送装置100的外表面上提供的导电材料510相互作用。与导电材料510类似,导电膜618可以是任何能够实现热传递的材料。示例性导电膜材料包括但不限于银、铜、金、铝、黄铜、锌、镍、铁、锡、磷青铜、钢和铅。在优选实施方式中,导电膜618包括铜。
冷却套管600还可以通过使用压力降低温度来提供冷却,如图10所示。在该实施方式中,至少一个腔室613设置在空间612内。该至少一个腔室613沿平行于纵轴的第二轴延伸。在一个方面,腔室613是圆柱形的。腔室613包含待压缩的流体。在空间612内可设置任意数量的腔室,如1、2、3、4、5、6、7、8、9、10、15、20、25以及之间的任意数量。
用于压缩一个或多个腔室613中的流体的加压气体提供在盖614内,盖614形成高压气腔室。在一个方面,柱塞615设置在腔室613内。当需要冷却时,压缩气体通过气体释放机构690从盖614释放。压缩气体向下推动柱塞615,从而启动柱塞615以压缩流体。流体的快速压缩产生对腔室640的快速冷却,从而冷却和/或保持冷料浆输送装置100内腔室640中流体/料浆的冷温度。
在本实施方式的一个方面中,腔室613的朝向圆柱形构件110的壁的至少一部分包括导电膜,用于与导电材料510相互作用以帮助传递热量。背离圆柱形构件110的腔室壁的至少一部分包括厚膜611。
此外,在使用上述任何设备和装置生成冷料浆的过程中,柱塞120可用于在流体上产生负压,以实现降低流体的冻结温度。这样的例子如图11A和11B所示。11A示出了被向上拉向冷料浆输送装置100的第一端112之前的柱塞120,而11B中的柱塞120则正被向上拉向冷料浆输送装置100的第一端112,以对流体产生负压。因此,11B中的流体压力低于11A中的流体压力。
根据本发明的另一个实施方式,可使用冷却源和可注射流体(任选地借助于固体盐水源)在单独的腔室(料浆生成腔室300)中生成冷料浆。在一个方面,料浆生成腔室300的体积小于约1L,例如小于约800ml、小于约700ml、小于约600ml、小于约500ml、小于约400ml、小于约300ml、小于约200ml、小于约100ml、小于约90ml、小于约80ml、小于约70ml、小于约60ml、小于约50ml、小于约25ml、及小于约10ml。
如图12所示,料浆生成腔室300具有顶端312和底端314。顶端312包含连接器305。在一个方面,料浆生成腔室300至少分为3个隔室。第一隔室310容纳适于注射到患者体内的可注射流体。所述可注射流体可包含盐、糖、和/或以上提供的任何其它药学上可接受的赋形剂。第一隔室310可包括刚性壳体或可以是柔性的,使得当流体从第一隔室310喷出时形成真空。在形成真空的情况下,可以产生蒸汽。因此,料浆生成腔室300还包括用于蒸汽的空气空间340,该空间朝向腔室300的顶端312定位。在一个方面,还提供蒸汽释放阀345。
第二隔室320最初可以是空的,或者可以包括固体盐水源。在一个实施方式中,固体盐水源是多个盐水填充颗粒340。颗粒340可以是任何形状,例如球形、圆柱形、环面形、圆锥形、正方形、椭圆形等。应当理解,颗粒340不必是完美的形状,而可以包含瑕疵和奇形怪状。在一个实施方式中,颗粒340基本上是球形的。在另一实施方式中,颗粒340在外表面上具有结节或凸起,如图12所示。结节的作用是增加可供相互作用的表面积。结节还提供额外的搅拌和将340颗粒彼此分离的能力。
第一隔室310和第二隔室320通过分离构件360彼此分离。分离构件360可包括一个或多个阀,当达到一定压力或收到可操作地连接到分离构件360的释放触发器发出的信号时,可以打开这些阀。或者,分离构件360可包括可破裂密封件,该可破裂密封件通过扭转料浆生成腔室300的一部分或通过使用触发器而被破裂。一旦分离构件360被破坏,来自第一隔室310的流体和包含在第二隔室320中的流体和/或盐水填充颗粒340将混合在一起。
第三隔室330包括冷却流体,该冷却流体可安全地在患者体内输送。在优选实施方式中,冷却流体压缩于第三隔室330内。示例性冷却流体包括液氮、HCF-134A、和其它被环境保护局和政府实体视为可接受的制冷剂。优选地,冷却流体对人体是安全的。
第三隔室330通过一个或多个阀350与第二隔室320流体连通。在一个实施方式中,将阀350设置为在预定压力下打开。在另一个实施方式中,阀350在收到释放触发器355发出的信号时打开,该释放触发器355可操作地耦接到阀350。在一个方面,阀350是单向阀,使得流体仅沿从第三隔室330到第二隔室320的方向流过阀350。
优选地,直到正要在照护现场交付冷料浆之前,三个隔室(310、320、和330)的内容物彼此都保持分开。保持隔室分开确保了冷料浆在需要时才会产生。通过这种方式,可以在单独的设施中大量生产料浆生成腔室300,并且无需冷藏即可装运;在照护现场产生冷料浆仅需的操作是激活释放触发器355并使料浆生成腔室300摇动。
在一个具体实施方式中,如图12所示,在一个实施方式中,第一隔室310朝向料浆生成腔室300的顶端312设置,第三隔室330朝向料浆生成腔室300的底端314设置,第二隔室320的大部分位于第一隔室310和第三隔室330之间。在该实施方式的一个方面中,第二隔室320的一部分围绕第一隔室310,使得第二隔室320设置在第一隔室310和料浆生成腔室300的壁之间。
在操作中,打开阀350将冷却流体从第三隔室330释放到第二隔室320中。冷却流体与盐水填充颗粒340相互作用,将颗粒340的温度降低到所需的温度。当冷却流体流入第二隔室320时,冷却流体还将降低第一隔室310中包含的可注射流体的温度。
一旦盐水填充颗粒340被冷却到所需的温度,就会发生有意破坏分离构件360的情况,使得颗粒340和可注射流体混合。冷却的盐水填充颗粒340继续降低可注射流体的温度,从而最终形成冷料浆。当温度下降时,冷却的盐水填充颗粒340也可用于搅拌和分离冷料浆中形成的冰晶。此外,料浆生成腔室300将经受进一步的搅拌,例如通过摇动料浆生成腔室300,进一步的搅拌通过增加可注射流体和冷却的盐水填充颗粒340之间的相互作用而帮助冷料浆形成。可使用与图3所示的冷料浆输送装置100类似的其它搅拌冷料浆的方式,例如振动和旋转。
在一个实施方式中,一旦盐水填充颗粒340达到所需的温度,冷却流体在分离构件360破裂之前从料浆生成腔室300释放。一旦冷却流体释放,分离构件360就会破裂。
在另一实施方式中,其中第二隔室320最初为空(例如,颗粒340未提供给第二隔室320),冷却流体仍会释放到第二隔室中。在该实施方式中,一旦释放,冷却流体将从第三隔室330流入第二隔室320,并通过第二隔室320循环。如先前公开的,第二隔室中冷却流体的循环将使容纳于第一隔室310内的可注射流体冷却。
冷料浆形成后,冷料浆可从料浆生成腔室300输送至冷料浆输送装置100,如图13所示。在优选实施方式中,如图13A所示,冷料浆输送装置100和料浆生成腔室300通过阳性连接器145和阴性连接器305配合,以将料浆生成腔室300可拆卸地连接到冷料浆输送装置100,冷料浆通过连接器145、305从料浆生成腔室300转移出来。可通过拉动冷料浆输送装置100的柱塞120产生负压和/或推动腔室柱塞370来实现转移。在将盐水填充颗粒340提供给料浆生成腔室300的实施方式中,可以在冷料浆通过阴性连接器305离开料浆生成腔室300之前提供过滤器(未显示)。过滤器防止盐水填充颗粒340随冷料浆流入冷料浆输送装置100和/或堵塞阴性连接器305的开口。在一个实施方式中,料浆生成腔室300产生足够的冷料浆用于冷料浆输送装置100的单次注射。在另一实施方式中,料浆生成腔室300产生足够的冷料浆用于两次或更多次的注射。
还设想了用于输送在料浆生成腔室300中产生的冷料浆的其它装置。例如,装配有连接管的导管或套管可以连接到料浆生成腔室300。在一个方面,电池驱动的泵可以配备料浆生成腔室300,以实现冷料浆通过管道流入套管/导管,用于输送到患者体内。
在本发明的一个方面,充分组装的料浆生成腔室300可与用于输送冷料浆的装置一起提供在套件中。这样,产生和输送冷料浆到患者体内仅需的操作是激活料浆生成腔室300,并将冷料浆从料浆生成腔室300输送到输送装置。
在本发明的一个方面,提供了温度传感器来监测流体/冷料浆的温度。根据本发明,可使用本领域已知的任何温度传感器装置,例如温度计、热电偶、和其它温度测量装置。测量可以在装有冷料浆的容器内部或外部进行。可选地或另外地,可以向冷料浆或装有冷料浆的容器中的一个或两个提供添加剂,其可以改变颜色来指示已经达到所需温度和/或冷料浆不再处于所需温度。
在本发明的另一方面,可将由上述设备和方法产生的冷料浆提供给患者体内的组织,例如,用于对患者进行治疗。可以施用冷料浆的组织包括结缔组织、上皮组织、神经组织、关节组织、心脏组织、脂肪组织、肝组织、肾组织、血管组织、皮肤组织、和肌肉组织中的一种或多种。另外,方法包括使用由本文所述设备将和/或将由本文所述设备产生的冷料浆输送到以下任何一个或多个位置:靠近神经、靠近皮下脂肪组织、靠近乳腺组织、靠近内脏脂肪、靠近咽部的脂肪组织、靠近上颚的脂肪组织、靠近舌头的脂肪组织、靠近脊髓脂肪瘤、靠近内脏脂肪、靠近脂肪瘤、靠近肿瘤、靠近心脏组织、靠近心包脂肪、和靠近心外膜脂肪。可通过向受试者递送冷料浆来治疗的各种病况、病症或疾病包括肥胖、睡眠呼吸暂停、神经痛、和任何其它疾病或病症,例如国际申请公开WO/2016/033380中所公开的那些疾病或病症,所述国际申请公开整体并入本文。可选地或另外地,即使患者没有患有某种病况、病症或疾病,也可根据本发明将冷料浆输送给患者,以通过减少脂肪、脂肪团、皱纹等来改善患者的美观。
在优选实施方式中,将冷料浆输送到患者体内的脂肪组织或其附近,以诱导组织细胞凋亡,如图14大致所示。使用用于输送冷料浆的装置(例如图3中的冷料浆输送装置100)或任何其它注射器型装置、导管或套管将冷料浆输送到目标组织。
在示例性方法中,清洁患者皮肤上的区域,用于输送冷料浆的装置将通过该区域进入,并在皮肤上标记入口点。入口点可以通过视觉或通过使用一种或多种成像技术(如超声波、磁共振、和X射线)进行识别。然后将该装置插入入口点并推进到目标组织。然后在目标组织处(或附近)注入冷料浆。一定量的冷料浆可以输送到目标组织(或附近)的多个部位。在一些情况下,注射到多个部位会增加暴露于冷料浆中并被冷却的目标组织的量,并且可以提高治疗的有效性。
通过诱导组织细胞凋亡,去除脂肪细胞,从而减少患者体内的脂肪量,进而改善患者的美观和/或用于治疗肥胖(以及其它疾病或病症)。脂肪组织包括白色脂肪组织和褐色脂肪组织。脂肪组织可以在皮肤下(皮下脂肪)、内脏器官周围(内脏脂肪)、骨髓、肌间、和乳腺组织内找到。可将冷料浆输送至脂肪组织的区域包括但不限于面部、颈部、下巴下的颏下区域、下颌、眼睑、眶下脂肪袋、后颈(水牛驼峰)、背部、肩膀、手臂、肱三头肌、肱二头肌、前臂、手、胸部、乳房、腹部、侧腹(腰间赘肉)、下背部、臀部(香蕉条)、臀部(马鞍袋)、大腿前后、大腿内侧、阴阜、外阴、膝盖、膝盖以上、小腿、胫骨、胫前区、脚踝、和脚。预期可将冷料浆输送至任何需要减少脂肪的皮下脂肪袋中。
等效替代
虽然已结合某些优选实施方式描述了本发明,但普通技术人员在阅读上述说明书后,将能够对本文所述的设备和方法进行各种改变、等效替代及其它更改。
Claims (11)
1.一种用于生产用于输送到患者体内组织的冷料浆的设备,其特征在于,该设备包括:
包含可注射流体的第一隔室;
第二隔室;
包含冷却流体的第三隔室;以及
其中,提供所述冷却流体以将所述可注射流体冷却。
2.根据权利要求1所述的设备,其特征在于,所述第二隔室包含多个颗粒。
3.根据权利要求2所述的设备,其特征在于,所述多个颗粒是盐水填充颗粒。
4.根据权利要求1所述的设备,其特征在于,所述第一隔室和所述第二隔室通过分离构件彼此分离。
5.根据权利要求4所述的设备,其特征在于,所述分离构件是易碎的密封件,所述密封件配置为破裂以使得所述第二隔室的内容物与所述第一隔室中的所述可注射流体混合。
6.根据权利要求1所述的设备,其特征在于,所述第二隔室和所述第三隔室通过一个或多个释放机构彼此流体连通,所述一个或多个释放机构配置为被触发时将所述第三隔室中的所述冷却流体释放到所述第二隔室中。
7.一种使用料浆生成腔室生成冷料浆的方法,其特征在于,所述方法包括:
提供料浆生成腔室,所述料浆生成腔室包括:
包含可注射流体的第一隔室;
第二隔室;
包含冷却流体的第三隔室;以及
将所述冷却流体从所述第三隔室释放到所述第二隔室,以将所述第一隔室中的所述可注射流体冷却并生成冷料浆。
8.根据权利要求7所述的方法,其特征在于,所述第二隔室包括多个颗粒,所述多个颗粒配置为在生成所述冷料浆时搅拌所述可注射流体。
9.根据权利要求7所述的方法,其特征在于,所述方法进一步包括在将所述冷却流体从所述第三隔室释放到所述第二隔室之后,将所述第二隔室的内容物释放到所述第一隔室中。
10.根据权利要求7所述的方法,其特征在于,所述方法进一步包括向所述料浆生成腔室提供搅拌。
11.根据权利要求7所述的方法,其特征在于,提供的搅拌包括摇动所述料浆生成腔室。
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- 2017-10-31 KR KR1020197015786A patent/KR20200020657A/ko active IP Right Grant
- 2017-10-31 CN CN202111113883.3A patent/CN113828180A/zh active Pending
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JP2020500667A (ja) | 2020-01-16 |
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EP3534852A4 (en) | 2020-09-30 |
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US20180116868A1 (en) | 2018-05-03 |
AU2017355364A1 (en) | 2019-05-23 |
JP2022033376A (ja) | 2022-03-01 |
US20210275351A1 (en) | 2021-09-09 |
EP3534852A1 (en) | 2019-09-11 |
SG11201903946SA (en) | 2019-05-30 |
ZA201903072B (en) | 2021-09-29 |
ES2908654T3 (es) | 2022-05-03 |
CA3042402A1 (en) | 2018-05-11 |
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