CN110913781A - 冷浆容纳物 - Google Patents
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Abstract
本发明提供用于控制递送到目标组织的冷浆和用于限制热量从周围组织传递到该目标组织的方法和装置。具体地说,气囊结构被部署在递送点处或附近,以充当物理和/或热屏障。在一些情况下,该气囊结构可以充当压力装置,从而阻挡能够融化该冷浆的温热血液流入治疗区域中。
Description
相关申请的交叉引用
本申请根据35U.S.C.§119(e)要求于2017年4月5日提交的美国临时申请序列号62/482,008的权益,这些美国临时申请的全部公开内容通过引用并入本文中。
背景技术
医疗应用中使用的冷浆通常包括部分冷冻的盐溶液。冷浆被用于外科手术应用中,以诱导治疗性低温并减缓器官和组织代谢率,从而在外科手术过程中保护患者的器官。冷浆也可以注射到患者体内以进行选择性或非选择性冷冻疗法和/或冷冻脂解。
用于制备冷浆并通过插管或针将其递送到脂肪组织的方法公开于国际申请第PCT/US 2015/047292号;美国专利申请公开第2013/0190744号;以及美国临时申请第62/416484号中,这些申请以全文引用的方式并入本文中。冷浆具有高流动性,使得可以通过细小的插管或针注射冷浆。一旦递送冷浆,热量就会从目标组织传递到冷浆。这降低了目标组织的温度,使得冷冻脂解可以发生。
因为冷浆具有高流动性,所以其倾向于从递送到周围组织的地方扩散。三立方厘米体积的冷浆可以覆盖大约一个碟盘大小的区域。来自周围组织的热量也被传递到冷浆中。此外,流入到治疗区域中的血液可能使冷浆温热。随着更多的热量传递到冷浆中,冷浆降低目标组织的组织温度的能力下降。因此,有效的治疗可能需要更多冷浆。递送冷浆的另一个挑战是保护围绕目标组织的组织免受冷浆的冷却效果。
发明内容
本发明提供了用于控制递送到目标组织的冷浆和用于限制热量从周围组织传递到该目标组织的方法和装置。具体地说,气囊结构被部署在递送点处或附近,以充当物理和/或热屏障。在一些情况下,该气囊可以充当压力装置,从而阻挡能够熔化该冷浆的血液流入到治疗区域中。
本发明中所用的气囊结构可以采用各种形式和形状,并且可以具有可以打开或关闭以控制该气囊的形状的腔室。在一些实例中,气囊彼此嵌套并填充有不同温度的各种流体或气体。例如,在一个实施例中,第一内气囊填充有水和甘油的冷混合物,而包围第一内气囊的第二内气囊填充有冷却剂气体/流体(例如,液氮),以冷冻或冷却第一内气囊中的冷混合物。甚至可以存在包围第二内气囊的第三气囊。第三气囊填充有如空气等热绝缘体,以保护周围组织免受第一内气囊和第二内气囊的低温影响。可以同时或分时填充多个气囊。
可以使用部署装置来部署气囊。该装置可以具有用于控制气囊或气囊集合的功能的一个或多个工作通道。例如,该装置具有用于将多个气囊部署成一个在另一个内或彼此相邻的应用插管。在一些实例中,多个气囊可以通过一组部署装置投入使用。
本发明的一方面包含控制组织温度的方法。优选的方法包含将冷浆递送到位于受试者皮下的目标组织。随着热量从目标组织传递到冷浆,目标组织被冷却到较低的组织温度。方法进一步包含限制热量从周围组织传递到目标组织,这进而减缓组织温度升高。可以使用例如填充有热绝缘体(如流体、气体或空气)的气囊来限制热传递。流体/气体填充的气囊用作冷浆与周围组织之间的屏障(或障碍物)。流体/气体填充的气囊也可以用作对周围组织施加压力的压力装置。施加的压力可以使周围组织中的血管收缩并限制温热血液流入到治疗区域中。
本发明的另一方面是一种用于执行上述方法的装置。优选的装置包含第一插管,该第一插管用于将冷浆递送到患者皮下的目标组织,从而使该目标组织冷却。该第一插管包含与冷浆源流体连通的第一开放远端和第一近端。装置进一步包含第二插管,该第二插管具有与热绝缘体源流体连通的第二开放远端和第二近端。装置进一步包含气囊,该气囊安置在该第二插管的该第二开放远端周围。该气囊定位在围绕该目标组织的组织处或附近。该气囊具有填充有已经通过该第二插管递送的热绝缘体的容积。填充的气囊限制热量从该周围组织传递到该目标组织。
该气囊可以具有面向该目标组织的第一腔室和面向该周围组织的第二腔室。该第一腔室与该第一开放远端流体连通并且填充有通过该第一插管递送的冷浆。该第二腔室与该第二开放远端流体连通并且填充有通过该第二插管递送的该热绝缘体。这种配置使该目标组织冷却,同时使该周围组织突出。
一些装置具有两个气囊。第一气囊安置在该第一插管的该第一开放远端周围并且定位在该目标组织处或附近。该第一气囊具有用于收容通过该第一插管递送的该冷浆的容积。第二气囊安置在该第二插管的该第二开放远端周围。第二个具有填充有该热绝缘体的容积。该第一气囊含有在其容积内的该冷浆,而定位在围绕该目标组织的组织处或附近的该第二气囊限制热量从该周围组织传递到该目标组织。
本发明的又另一方面是一种容纳装置,该容纳装置应用于患者的皮肤上以从患者体外限制/控制冷浆扩散和/或其冷却效果。该容纳装置具有限定容纳区的开口,冷浆和/或其冷却效果被局限在该容纳区内。该开口被用于在容纳区周围施加压力的压力表面包围。
优选的装置包含压力表面,该压力表面内部中空并且在填充有流体或气体(如空气)时可以膨胀。通过将空气/流体泵入到压力表面中来施加力,从而使其膨胀并压在患者皮肤上。由于该开口,目标组织经受很少压力或没有压力。另一方面,周围组织经受正压力。该正压力限制冷浆从目标组织扩散到周围组织和/或其冷却效果。此外,由容纳装置施加的压力可以使周围组织中的血管收缩并限制温热血液流入到治疗区域中。
一些容纳装置可以具有分为区段(例如,同心环)的压力表面。这些区段可以单独地填充,使得由每个区段施加的压力不同。例如,填充最靠近开口的第一区段,使得施加在患者皮肤上的压力大于由第二区段施加的压力。由容纳装置施加的压力的差异可以帮助控制冷浆的迁移。此外,由容纳装置区段施加的不同压力可以促进组织形成轮廓。
本发明的仍又另一方面是一种用于从治疗区域中移除融化冷浆的温热流体移除装置。优选的装置具有距目标组织某一距离定位并在周围组织内的远端。这些装置进一步包含联接到真空泵的近端,该真空泵提供吸力以从治疗区域中移除温热流体。该真空泵可操作地联接到用于操作真空泵的控制器。该控制器可以连续地或间歇地操作真空泵。该控制器还可以使用温度探针监测目标组织的温度,并响应于升高的组织温度而操作温热流体移除装置。
实例温热流体移除装置可以是U形的,并在使用时围绕目标组织。这些装置具有沿其长度限定的多个孔,通过这些孔从治疗区域中移除温热流体。该温热流体移除装置还可以包含开放远端以进一步增强将温热流体从治疗区域中移除。这些装置可以进一步具有非操作模式和操作模式。在非操作模式下,温热流体移除装置的形状是基本上线性的。在非操作模式下,温热流体移除装置可以容易地插入患者的皮肤、向前推进到围绕目标组织的组织,并在冷浆治疗完成后从患者体内移除。在操作模式下,温热流体移除装置是U形的,其开口端面向目标组织。例如,温热流体移除装置可以通过张力线在非操作模式与操作模式之间机械致动。在另一个实例中,温热流体移除装置由形状记忆合金(如镍钛诺)制成。响应于温度变化,温热流体移除装置可以从线性形状变为U形,并且再变回线性形状。
附图说明
图1是用于递送冷浆并控制其迁移和/或冷却效果的方法的示意图。
图2是用作保护神经免受冷浆的冷却效果影响的热屏障的气囊的侧视图。
图3是用作限制血液流入到治疗区域中的压力装置的气囊的侧视图。
图4是冷浆递送装置的截面视图。
图5是用于递送和补充冷浆的冷浆递送装置的视图。
图6是用于将冷浆递送到目标组织并保护相邻组织免受冷浆的冷却效果影响的双腔室气囊的截面视图。
图7是具有突出臂的实例气囊的视图。
图8是具有多个隔室的实例气囊的视图。
图9是实例冷浆温度监测器的视图。
图10是具有多个温度传感器的实例冷浆温度监测器的视图。
图11A和11B是用于从患者体外控制冷浆和/或其冷却效果的实例容纳装置的视图。
图12A和12B是用于从治疗区域中移除融化冷浆的实例温热流体移除装置的视图。
图13A-13C是用于部署冷浆容纳装置的实例引导件的视图。
图14A和14B示出了带开窗的插管与处于缩回和膨胀状态的气囊。
图15示出了带开窗的插管的各种开口设计以及用浆液延伸通过这些插管时所产生的气囊的形状。
具体实施方式
图1示出了注射到患者体内的冷浆。具有插管的冷浆递送装置100插入患者的皮肤并向前推进到目标组织105(以虚线示出)处或附近的位置。然后递送冷浆110。来自目标组织105的热量被传递到冷浆110,该冷浆进而降低了目标组织105的温度。递送后,受冷浆110影响的区域膨胀至大于初始递送位点的尺寸(在图中示出为从递送的冷浆110向外辐射的箭头和尺寸增大的虚线圆圈)。
图1进一步示出了用于控制冷浆110的冷却效果的方法。具有应用插管120的部署装置115插入患者的皮肤。在应用插管120的远端处,存在控制端125。部署装置115向前推进,直到控制端125处于目标组织105与相邻(周围)组织135之间的位置处。控制端125包含气囊130。虽然气囊130示出为具有线性形状,但是其可以具有任何形状,如包围目标组织105的环。气囊130填充有空气以在相邻组织135与扩散的冷浆110之间形成屏障。气囊130限制热量从相邻组织135传递到冷浆110。
该方法提供了若干益处。通过充当温度屏障,气囊130可以减缓融化过程,从而延长冷浆110的有用性。气囊130可以进一步帮助使目标组织105保持冷的状态,并且因此增加冷浆治疗的有效性。通过充当温度屏障,气囊130还保护相邻组织135免受由寒冷造成的不利影响或损伤。例如,图2示出了放置在冷浆110与神经140之间的气囊130。气囊130限制了冷浆110对神经140的冷却效果。有益的是,这降低了损伤神经140的可能性。
图3示出了气囊130的另一个应用。填充有空气或流体的气囊130放置在血管150旁边。如图所示,气囊130对血管150施加压力,从而使其收缩并限制血流155。通过减少流入到治疗区域中的温热血液的量,气囊130可以减缓融化过程,从而延长冷浆的有用性。气囊130可以进一步帮助目标组织保持冷的状态,并且因此增加冷浆治疗的有效性。
图4示出了实例冷浆递送装置200。装置200包含应用插管205,该应用插管在其远端处开放并限定出口210。控制端215包含安置在出口210周围的外气囊220。应用插管205与外气囊220的内部容积流体连通。应用插管205包含流体递送插管225。应用插管205和流体递送插管225共享公共纵向轴线,并且可以说是同轴对齐的。
流体递送插管225在其远端处开放,从而限定流体出口230。控制端215进一步包含安置在流体出口230周围的内气囊235。流体递送插管225与内气囊235的内部容积流体连通,该内部容积在图中标记为240。内气囊235位于外气囊220内。如图所示,内气囊235占据外气囊220的内部容积的一部分,从而在内气囊235的外壁(图中标记为250)与外气囊220的内壁(图中标记为255)之间留下空间或空隙245。
为了使用冷浆递送装置200,应用插管205插入患者的皮肤,并且控制端215以与上文参考图1描述的方式几乎相同的方式向前推进到目标组织处或附近的位置。在该实例中,外气囊220和内气囊235以其未充气状态插入到患者体内。外气囊220填充有通过应用插管205供应的空气。内气囊235填充有通过流体递送插管225供应的冷浆260。填充内气囊235与外气囊220之间的空隙645的空气用作绝缘体,并保护周围组织免于损伤。内气囊235也可以填充有流体、凝胶、无机气凝胶、泡沫或其它热绝缘体。
图5示出了用于递送冷浆的冷浆递送装置200的另一个实例。该实例与上文参考图4描述的实例类似,添加了流体回流插管265。如图所示,流体回流插管265与流体递送插管225一起容纳在应用插管205内。流体回流插管265从不再处于所期望的温度下的内气囊235中移除冷浆。以这种方式用“新鲜”冷浆补充“旧”冷浆可以适应冷浆的最终融化。这种方法对于需要长时间冷却的治疗特别有用。
图6示出了用于递送冷浆的实例气囊300。如图所示,气囊300具有第一腔室305和第二腔室310。第一腔室305填充有冷浆(或其它冷却流体)并面向目标组织315。第二腔室310填充有空气(或其它气体)并面向目标组织315附近的相邻组织320。这种配置允许气囊300冷却目标组织315,同时保护相邻组织320免受冷浆的冷却效果影响。
除了上文参照图1-5描述的线性和球形实例之外,气囊的实例可以具有任何形状。例如,图2示出了长度(L)大于宽度(W)并且凹形形状的气囊130。凹度点定义为沿着偏离且平行于纵向轴线165的轴线的点。作为另一个实例,图7示出了具有若干个突出臂或支柱355的气囊350。
气囊的其它实例可以具有多个可以打开或关闭以控制气囊的形状的腔室。例如,图8示出了具有四个隔室405a-405d(通常为405)的气囊400。隔室405可以填充有不同温度的各种流体或气体。气囊400的长度(L)大于其宽度(W)。
图9示出了用于测量冷浆温度的冷浆温度监测器500。冷浆温度监测器500可以是独立的装置或与冷浆递送装置100、200(图1和5)或部署装置115(图1)结合。如图所示,例如,冷浆温度监测器500从应用插管505(例如,冷浆递送装置100的插管)延伸。冷浆温度监测器500可以在图中所示的延伸位置与缩回位置之间移动。在缩回位置中,冷浆温度监测器500被遮蔽在应用插管505内。这有助于将冷浆温度监测器500插入患者的皮肤,并将监测器500向前推进到冷浆处或附近的位置。
在所示实例中,冷浆温度监测器500包含处于其远端尖端处的温度传感器510。在不限制本发明的原理的情况下,温度传感器510可以为前向红外(FIR)传感器。如图所示,冷浆温度监测器500可以移动到缩回位置与伸出位置之间的中间位置。这些中间位置以及伸出位置对应于冷浆内的不同位置,这些不同位置在图中标记为“A”到“E”。通过将冷浆温度监测器500移动到中间位置和伸出位置,可以确定冷浆的温度梯度(或“温度深度”)。温度梯度进而可以用于评估例如冷浆使目标组织冷却的能力(性能)。
图10示出了冷浆温度监测器500的另一个实例,该冷浆温度监测器具有沿监测器500的长度间隔开的多个传感器515a-e(通常为515)。传感器515中的每一个传感器对冷浆内的不同位置进行测量。例如,传感器515c测量在图9中标记为“C”的位置处的冷浆的温度。以这种方式,在不必移动冷浆温度监测器500的情况下,可以确定冷浆的温度梯度。
图11A示出了图1的冷浆递送装置100,该冷浆递送装置将冷浆递送到患者皮下的目标组织105(以虚线示出)。容纳装置600应用在患者皮肤上以从患者体外控制冷浆扩散和/或其冷却效果。容纳装置600具有限定容纳区610的开口605,冷浆和/或其冷却效果基本上被局限于该容纳区内。开口605被用于在容纳区610周围施加压力的压力表面615包围。如图所示,应用容纳装置600,其中开口605置于目标组织105上,并且压力表面615置于周围组织135上(以虚线示出)。
在容纳装置600的方便的实例中,压力表面615内部中空并且当填充流体或气体(如空气)时可以膨胀。通过将空气/流体泵入到压力表面615中来施加力,从而使其膨胀并压在患者皮肤上。由于开口605,目标组织105经受很少压力或没有压力。另一方面,周围组织135经受正压力。该正压力限制冷浆从目标组织105扩散到周围组织135和/或其冷却效果。此外,施加的压力可以使周围组织135中的血管收缩并限制温热血液流入到治疗区域中。
施加的压力可以通过将空气/流体泵出压力表面615从而使其放气来减小或移除。在方便的实例中,将空气/流体泵入和泵出压力表面615是自动完成的。例如,空气/流体被泵入到压力表面615中,使得容纳装置600在冷浆治疗开始或接近开始时施加压力。在预定量的时间之后,空气/流体被泵出压力表面615,从而在冷浆治疗结束或接近结束时从容纳装置600释放压力。
如图11B所示,压力表面可以被分成区段620(示出为第一区段620a和第二区段620b)。例如,这些区段620可以是同心环。这些区段620可以单独地填充,使得由每个区段施加的压力不同。例如,填充最靠近开口605的第一区段620a,使得施加在患者皮肤上的压力大于由第二区段620b施加的压力。由容纳装置600施加的压力的差异可以帮助控制冷浆的迁移。此外,不同的压力可以促进组织形成轮廓。
在容纳装置的另一个实例中,压力表面是固体的。当在容纳装置上施加力时,由于开口,目标组织经受很少压力或没有压力。另一方面,周围组织经受正压力。该正压力限制冷浆从目标组织扩散到周围组织和/或其冷却效果。此外,施加的压力可以使周围组织中的血管收缩并限制温热血液流入到治疗区域中。
固体压力表面可以分成区段,例如同心环。可以添加或移除这些区段,以使开口的尺寸扩大并且进而使容纳区变大或变小。也可以添加或移除这些区段,以使压力表面的尺寸变大或变小并且因此改变施加压力的区域。
在所示实例中,容纳装置600具有圆形形状,其中开口605位于中心并且压力表面615与开口605同心。进一步地,如图所示,压力表面615是基本上平坦的表面。容纳装置600可以具有适合于向患者身体的一部分施加压力的任何形状。例如,容纳装置600可以为矩形、三角形或其它规则形状。容纳装置600也可以具有适配成适形于被治疗的患者身体的一部分的不规则形状。例如,容纳装置600可以为凹入的以负担例如患者的胃。容纳装置600的凹度是在使用该装置的情况下限定的。
如图所示,开口605和压力表面615轴向对齐,即共享同一轴线。在其它实例中,开口605的轴线和压力表面615的轴线偏移某一距离。容纳装置600的该非轴向实例可以用于期望将冷浆容纳物或多或少地偏置到目标组织105的一侧的应用中。
容纳装置600可以由塑料、聚合物、橡胶或其它适合于向患者身体的一部分施加压力的材料制成。容纳装置可以手动使用,例如,临床医生将装置600按压(例如,通过容纳装置上的手柄)在患者皮肤上。容纳装置600的使用还可以促进通过条带或夹具将容纳装置600包裹在患者身体的一部分周围。
图12A示出了图1的将冷浆递送到患者皮下的目标组织105的冷浆递送装置100。来自目标组织105的热量被传递到冷浆110,该冷浆进而将目标组织105的温度降低到第一温度Tl。递送后,冷浆110向四周扩散并影响比初始递送位点更大的区域(在图中示出为从递送的冷浆110向外辐射的箭头和尺寸增大的虚线圆圈)。随着冷浆110向四周扩散,冷浆融化并将周围组织135的温度降低到第二温度T2,该第二温度比第一温度T1热。
温热流体移除装置700从治疗区域中移除所产生的温热流体。温热流体移除装置700具有距目标组织105某一距离并在周围组织135内的远端705。温热流体移除装置700进一步包含联接到真空泵715的近端710。真空泵715提供吸力以从治疗区域中移除温热流体。
真空泵715可操作地联接到用于操作真空泵715的控制器720。控制器720可以连续地操作真空泵715,使得温热流体被不断地移除。控制器720可以间歇地操作真空泵715,使得温热流体以预定的间隔被抽出。在方便的实例中,控制器720使用温度探针(例如,类似于上文参考图9和10描述的冷浆温度监测器500的探针)监测目标组织105的温度。当目标组织105的温度上升到第一温度T1以上时,控制器720通过操作真空泵715并从治疗区域中移除温热流体来响应。
图12B示出了用于从治疗区域中移除温热流体的另一实例温热流体移除装置750。通常,温热流体移除装置750具有钩状形状。如图所示,温热流体移除装置750为U形的,其中开放端755面向目标组织105。温热流体移除装置750进一步具有沿其长度限定的多个孔760,通过这些孔从治疗区域中移除温热流体(如箭头所示)。温热流体移除装置750可以包含开放远端765以进一步增强将温热流体从治疗区域中移除。
在方便的实例中,温热流体移除装置750具有非工作模式和工作模式。在非操作模式下,温热流体移除装置750的形状是基本上线性的。在非操作模式下,温热流体移除装置750可以容易地插入患者的皮肤、向前推进到围绕目标组织的组织,并从患者体内移除。
在操作模式下,温热流体移除装置750为U形的,其中开放端755面向目标组织105,如图12B所示。例如,温热流体移除装置700可以通过张力线在非操作模式与操作模式之间机械致动。在另一个实例中,温热流体移除装置750由形状记忆合金(例如,镍钛诺)制成。
温热流体移除装置750进一步包含联接到真空泵775的近端770。真空泵775提供吸力以从治疗区域中移除温热流体。控制器781可以连续地操作真空泵775,使得温热流体被不断地移除。控制器720可以间歇地操作真空泵775,使得温热流体以预定的间隔被抽出。在方便的实例中,控制器780使用温度探针(例如,类似于上文参考图9和10描述的冷浆温度监测器500的探针)监测目标组织105的温度。当目标组织105的温度上升到第一温度T1以上时,控制器780操作真空泵775以从治疗区域中移除温热流体。
图12A的温热流体移除装置700(或图12B的650)和图1的冷浆递送装置100可以一起操作,例如使用控制器720以用“新鲜”冷浆补充“旧”冷浆。补充冷浆可以间歇地发生,使得温热流体被抽出并且冷浆以预定的间隔被递送。
在方便的实例中,控制器720使用温度探针(例如,类似于上文参考图9和10描述的冷浆温度监测器500的探针)监测目标组织105的温度。当目标组织105的温度上升到第一温度T1以上时,控制器720通过以下来响应:通过操作温热流体移除装置700以从治疗区域中移除温热流体;并且通过操作冷浆递送装置105以将冷浆递送到目标组织105。这种配置对于冷却组织持续延长的时间段特别有用。
在方便的实例中,上述装置中的任一种装置都可以使用引导件来部署。图13A-13C示出了与图1的部署装置115一起使用的引导件800的实例。引导件800包含用于容纳应用插管120和气囊130的工作通道805。工作通道800插入患者的皮肤并朝着治疗区域向前推进。在治疗区域处,部署装置115被推出工作通道,如图13B所示。然后,气囊130被充有流体或气体(如空气),如图13C所示,并用于控制冷浆和/或其冷却效果,如上所述。当治疗完成时,气囊130放气并被拉回到工作通道805中。然后将引导件800从患者体内取出。引导件800可以具有一个或多个工作通道以控制气囊或气囊集合的功能。
在各个实施例中,带开窗的针或插管设置有一个或多个迷你或微型气囊,当填充有治疗性冷流体或浆液时,这些气囊使表面积大幅增加,插管可以通过该表面积从周围组织传递热量。气囊可以在例如小肠绒毛之后进行建模,并且可以从如图14A和14B所示的单个针或插管或通过针或插管的阵列展开。当浆液或冷溶液流过插管或针时,气囊的膨胀和缩回可以取决于壁压的差异。
图14A和图14B示出了示例性带开窗的针或插管。与气囊1407材料相比,带开窗的插管1401可以由相对刚性或非柔性的材料构造而成。由相对柔性或可膨胀材料形成的气囊1407存在于刚性插管1401中的一系列开口1403中。插管1401可以具有实心尖端,以允许在添加浆液或流体时在插管的内腔1405内施加压力。随着流体或浆液的添加和内腔1405内压力的施加,相对柔性的气囊1407通过开口1403向外膨胀,如图14B所示。所产生的充满冷浆的膨胀的气囊使与周围组织热相互作用的表面积大幅增加。一旦流体或浆液流动停止,膨胀的气囊1407缩回开口1403内,如图14A所示,从而允许方便地插入和移除插管。
如图15所示,带开窗的插管的微型或迷你气囊可以具有多种不同形状。图15的左栏示出了本发明的带开窗的插管实施例中的不同开口的形状,并且右栏示出了当气囊膨胀通过左栏所示形状的开口时对应的气囊形状。例如,如图15所示,可以使用刚性材料(如插管本身的材料)分隔开口。通过将开口分为两个或四个部分,膨胀通过其的气囊将形成两个或四个单独的膨胀构件。在某些实施例中,开口内气囊材料的柔性可以如图15所示变化,以使膨胀的气囊呈现不同的形状。例如,不同柔性的同心环可以产生可能对某些治疗有利的椭圆形膨胀气囊。
Claims (27)
1.一种用于控制组织温度的装置,所述装置包括:
第一插管,所述第一插管用于将冷浆递送到患者皮下的目标组织,从而使所述目标组织冷却,所述第一插管包括与冷浆源流体连通的第一开放远端和第一近端;
第二插管,所述第二插管包括与热绝缘体源流体连通的第二开放远端和第二近端;以及
气囊,所述气囊安置在所述第二插管的第二开放远端周围并且被定位在围绕所述目标组织的组织处或附近,所述气囊包括填充有通过所述第二插管递送的所述热绝缘体的容积,其中填充的气囊限制热量从周围组织传递到所述目标组织。
2.根据权利要求1所述的装置,其中所述气囊包含面向所述目标组织的第一腔室和面向所述周围组织的第二腔室;
其中所述第一腔室与所述第一开放远端流体连通并且填充有通过所述第一插管递送的冷浆;并且
其中所述第二腔室与所述第二开放远端流体连通并且填充有通过所述第二插管递送的所述热绝缘体。
3.根据权利要求1所述的装置,其中所述气囊为第二气囊,并且所述权利要求进一步包括:
第一气囊,所述第一气囊安置在所述第一插管的第一开放远端周围,所述第一气囊包括用于收容通过所述第一插管递送的所述冷浆的容积。
4.根据权利要求3所述的装置,其中所述第一气囊包含多个区段,所述多个区段独立地填充有所述冷浆。
5.根据权利要求3所述的装置,其中所述第一气囊包含多个突出臂。
6.根据权利要求3所述的装置,其中所述第一气囊的长度大于其宽度。
7.根据权利要求1所述的装置,其进一步包括内气囊,所述内气囊安置在所述第一插管的第一开放远端周围,所述内气囊包括外表面和用于收容通过所述第一插管递送的所述冷浆的容积;
其中所述气囊为包括内表面的外气囊;并且
其中所述内气囊的外表面和所述外气囊的内表面形成所述热绝缘体的空间,所述空间用于填充热量并限制所述热量从所述周围组织传递到所述目标组织。
8.根据权利要求7所述的装置,其中所述第一插管包含在所述第一开放远端与所述第一近端之间延伸的第一纵向轴线;并且
其中所述第二插管包含在所述第二开放远端与所述第二近端之间延伸的第二纵向轴线,并且所述第二纵向轴线与所述第一纵向轴线对齐。
9.根据权利要求8所述的装置,其中所述第一纵向轴线与第二纵向轴线相同。
10.根据权利要求1所述的装置,其中所述第一插管和所述第二插管各自具有适于插入受试者的皮肤的大小和形状。
11.根据权利要求1所述的装置,其进一步包括冷浆温度监测器,所述冷浆温度监测器延伸超过所述第一开放远端以测量所递送的冷浆的温度。
12.根据权利要求11所述的装置,其中所述冷浆温度监测器包含处于所述冷浆温度监测器的远端处的温度传感器。
13.根据权利要求12所述的装置,其中所述温度传感器为前向红外(FIR)传感器。
14.根据权利要求11所述的装置,其中所述冷浆温度监测器包含沿所述冷浆温度监测器的长度间隔开的多个温度传感器。
15.根据权利要求1所述的装置,其中所述热绝缘体为流体、气体、空气、凝胶和气凝胶中的任一种。
16.根据权利要求1所述的装置,其中所述冷浆是水和甘油的混合物。
17.根据权利要求1所述的装置,其中所述气囊的长度大于其宽度。
18.根据权利要求1所述的装置,其中所述气囊通常是球形的。
19.根据权利要求1所述的装置,其中所述气囊具有纵向轴线并且如由沿平行于所述纵向轴线并偏离所述纵向轴线的线上的点所限定的那样凹入。
20.根据权利要求1所述的装置,其进一步包括引导件,所述引导件包括工作通道,所述工作通道的尺寸被设置成容纳所述第二插管和安置在所述第二插管周围的所述气囊;并且
其中所述气囊在使用时从所述工作通道展开。
21.一种用于控制组织温度的装置,所述装置包括:
带开窗的插管,所述带开窗的插管用于将冷浆递送到患者皮下的目标组织,从而使所述目标组织冷却,所述插管包括处于与冷浆源流体连通的第一远端和第一近端处的多个开口;以及
多个气囊,所述多个气囊各自安置在所述多个开口中的一个开口中并且被配置成当暴露于来自所述冷浆源的冷浆时膨胀并且由此为从所述目标组织到所述插管的远端处的所述冷浆的热传递提供增加的表面积。
22.根据权利要求21所述的装置,其中所述多个开口中的一个或多个开口被配置成当膨胀时赋予安置在其中的所述多个气囊某种形状。
23.根据权利要求22所述的装置,其中所述形状包括多个膨胀构件。
24.根据权利要求22所述的装置,其中所述形状包括卵形体。
25.根据权利要求22所述的装置,其中所述形状包括球体。
26.根据权利要求22所述的装置,其中所述多个气囊中的一个或多个气囊包括两个或更多个具有不同弹性的区域。
27.根据权利要求21所述的装置,其包括带开窗的插管的阵列。
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AU2018249540A1 (en) | 2019-10-31 |
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JP2020512881A (ja) | 2020-04-30 |
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KR20200015889A (ko) | 2020-02-13 |
SG11201909305PA (en) | 2019-11-28 |
US20230000671A1 (en) | 2023-01-05 |
BR112019020969A8 (pt) | 2022-11-16 |
EP3606456A1 (en) | 2020-02-12 |
WO2018187581A1 (en) | 2018-10-11 |
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