CN110868968A - 递送点冷浆料生成 - Google Patents

递送点冷浆料生成 Download PDF

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CN110868968A
CN110868968A CN201880030972.1A CN201880030972A CN110868968A CN 110868968 A CN110868968 A CN 110868968A CN 201880030972 A CN201880030972 A CN 201880030972A CN 110868968 A CN110868968 A CN 110868968A
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C·J·P·韦利斯
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Miraki Innovation Think Tank LLC
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Abstract

本发明提供了用于在递送点处制造冷浆料的方法和装置。一种递送点装置将冷浆料组分递送到靶组织处或附近的位置。将这些组分组合以在该递送点处或附近形成该冷浆料。这种用于在该递送点处生成冷浆料的方法允许维持和控制该冷浆料的特性，例如温度、颗粒形状和颗粒大小。

Description

递送点冷浆料生成
相关申请的交叉引用
本申请根据35U.S.C.§119(e)要求2017年4月5日提交的美国临时申请序列号62/482,003的权益，该美国临时申请的全部公开内容通过引用的方式并入本文中。
背景技术
医疗应用中使用的冷浆料通常包括部分冻结的盐溶液。冷浆料在外科应用中用于诱导治疗性低温和缓慢的器官和组织代谢率，由此在外科手术期间保护患者的器官。冷浆料还可以被注射到患者体内以进行选择性或非选择性冷冻治疗和/或冷冻溶脂。
以下文献中报告了用于制备冷浆料并将冷浆料穿过套管或针递送到脂肪组织的方法：国际申请第PCT/US2015/047292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，这些文献的全文通过引用的方式并入本文中。可注射的冷浆料的颗粒大小范围通常可以为0.1毫米到1.5毫米。颗粒通常呈球形，从而使冷浆料具有高流动性。这允许浆料容易流动穿过小直径的针。相比之下，由枝状晶体组成的冰凌难以无堵塞地注射。
用于制造可注射的冷浆料的传统方法是将盐溶液与冰混合，将它粉碎，并在注射之前对它进行调节。然后将所得的冷浆料传递到注射器以供注射。这种方法存在许多挑战，包含维持冷浆料颗粒的温度、形状和大小。随着浆料升温，颗粒会失去期望的形状和大小。当需要将大量冷浆料递送到许多不同区域时，冷浆料的融化问题会进一步加剧。到进行冷浆料的最后一次注射时，与第一次注射时相比，冷浆料明显不同。重新冻结冷浆料不是办法，因为这样做会造成形成了可能会堵塞注射针的枝状晶体。
发明内容
本发明提供了用于在递送点处制造冷浆料的方法和装置。一种递送点装置将冷浆料组分递送到靶组织处或附近的位置。将这些组分组合以在该递送点处或附近形成该冷浆料。这种用于在该递送点处生成冷浆料的方法允许维持和控制该冷浆料的特性，例如温度、颗粒形状和颗粒大小。
递送点生成还允许根据需要并连续地制造冷浆料。这对在会发生融化的长时间段内的治疗特别有用。本发明的即时(point ofcare)、适时(just-in-time)浆料递送在整个治疗过程中递送新鲜冷浆料，从而消除了对融化和浆料分解的担忧。本发明还可以极大地降低与批量制造冷浆料相关联的成本和时间。
本发明的一个方面包括在靶组织处或附近制造冷浆料的方法。优选方法包含递送制造冷浆料所需的组分。
第一组分可以是水或水混合物，例如水和甘油。由于这些组分之间的相互作用，冷浆料形成在该靶组织处或附近。用于制造冷浆料的组分的递送和冷浆料的形成可以连续地发生，使得在该靶组织处或附近存在稳定的新鲜冷浆料供应物。
用于形成冷浆料的优选成分包含液态水和固态水。还可以添加例如甘油的表面活性剂以增强该冷浆料的流动性。将液态水和该固态水混合以在该靶组织处或附近形成冷浆料。该固态水可以被破碎成颗粒，这些颗粒与该液态水混合以形成该浆料。固态水(即，冰)还可以由随后在该装置内冻结的另一种液态水供应物形成。
该冷浆料还可以依据过冷水与冰丸(种子)的成核在该靶组织处或附近被制造。在这种情况下，该过冷水是已经“过冷”到低于水的冰点的纯化液态水。该过冷水部分地由于其纯度而保持呈液态形式。当该过冷水与这些冰丸相互作用时，该过冷水会结晶并形成该冷浆料。
本发明的方法是使用递送点生成装置进行的。一种实例性装置包含：第一套管，该第一套管用于将第一组分递送到靶组织；以及第二套管，该第二套管用于将第二组分递送到该靶组织。该第一套管和该第二套管可以并排地布置，使得它们的相应出口大概对准以促进冷浆料形成。在一些实例中，该第一套管和该第二套管各自具有适合于穿过个体的皮肤插入的大小和形状。
冷浆料还可以使用气囊在靶组织处或附近被制造。在优选实施例中，该气囊包括外部气囊和内部气囊。该内部气囊被填充有穿过例如第一递送套管供应的液态水。该内部气囊与该外部气囊之间的空间被填充有穿过第二递送气囊供应的冷却流体或气体。这使冷浆料形成在该内部气囊内。可以任选地刺穿该内部气囊(例如由该装置上的穿刺针)以将该冷浆料释放在该靶组织处或附近。在该递送点生成装置的这个实例中，该第一递送套管和该第二递送套管同轴地布置。本发明还可以包含温度传感器，该温度传感器用于测量在该靶组织处或附近制造的该冷浆料的温度。本发明的以下详细描述中提供了本发明的其它因素和方面。
附图说明
图1是用于在患者体内生成冷浆料的方法的图解。
图2是用于由液态水和固态水形成冷浆料的递送点生成装置的生成端的视图。
图3A是用于由液态水和固态水形成冷浆料的另一个递送点生成装置的生成端的视图。
图3B是图3A的生成端的截面图。
图4是用于由第一液态水供应物形成固态水并且然后由固态水和第二液态水供应物形成冷浆料的递送点生成装置的生成端的视图。
图5是用于由过冷水和冰丸形成冷浆料的递送点生成装置的生成端的视图。
图6A和图6B是用于在气囊内形成冷浆料的递送点生成装置的生成端的视图。
图7是用于生成和补充冷浆料的递送点生成装置的视图。
图8是具有多个工作通道的递送点生成装置的视图。
具体实施方式
本发明的方法和装置包括用于将冷浆料即时递送到组织或器官的元件。本发明消除了在递送之前将浆料预混的需要，因此确保在治疗持续时间内将新鲜浆料(即，未结晶且处于适当相和温度)均匀地递送到所有治疗区域。在优选实施例中，在患者的递送点处原位制造浆料。用于生成浆料的组分(反应物)是在使浆料在适当温度下形成并且对于期望的治疗方案具有适当稠度的条件下提供的。在非常优选的实施例中，将本发明的方法皮下地提供到脂肪组织以使脂肪组织减少。还可以应用本发明的方法和装置以使内脏脂肪减少或者减轻疼痛。
图1示出了用于在患者体内制造冷浆料的递送点生成装置100的实例。装置100包含形状和大小被配置成穿过患者的皮肤插入的施加套管105。装置100以流体方式联接到提供用于制造冷浆料的组分的供应物110。在施加套管105的远端处，存在用于由这些组分形成冷浆料的生成端115。
通过将施加套管105穿过患者的皮肤插入并将生成端115推进到靶组织或治疗部位120(以假想线示出)处或附近的位置，使用了递送点生成装置100。靶组织120可以例如是皮下脂肪组织。例如液态水、固态水和甘油的冷浆料成分从供应物110穿过施加套管105被单独地泵送或以其它方式传送到生成端115之外。在生成端115处，组分彼此相互作用并在靶组织120处或附近形成冷浆料125。
冷浆料125的冷却效果集中到靶组织120并可能集中到周围组织，例如邻近的组织130。以此方式，由冷治疗造成的不适是有限的。冷浆料是无菌且生物相容的；并且因而，冷浆料125可以有利地留在体内(例如在已经实现冷却之后没有必要移除浆料)。
图2示出了用于依据将液态水和固态水混合来制造冷浆料的生成端115的实例。施加套管105容置用于供应液态水210(或水和甘油的液态混合物)的第一递送套管205，以及用于供应固态水(冰)220的第二递送套管215。第一递送套管205的远端为敞开式并形成供液态水210离开的第一出口230。第二递送套管215的远端为敞开式并形成供固态水220离开的第二出口235。出口230、235被布置成使得液态水210和固态水220随着离开而混合在一起以形成冷浆料。
图3A示出了用于依据将液态水和固态水混合来制造冷浆料的生成端115的实例。这个实例与上文参考图2所描述的实例类似，添加了位于第二出口235前面的研磨机240。在图3B的横截面图中更好地看出研磨机240相对于第二出口235的布置。随着固态水220从第二递送套管215显现，研磨机240将固体水220破碎成颗粒245。从第一递送套管205离开的液态水210与颗粒245混合以形成冷浆料。在另一个实例(未示出)中，振动器可以将固态水破碎成颗粒以在递送点处制造冷浆料。
图4示出了用于依据将液态水和固态水混合来制造冷浆料的生成端115的另一个实例。施加套管105容置用于提供第一液态水供应物310(或水和甘油的混合物)的第一递送套管305，以及用于提供第二液态水供应物320的第二递送套管315。如所示出，施加套管105进一步包含用于喷射冷却气体330并将第二水供应物320冻结成固态水335的气体管线325。
第一递送套管305的远端为敞开式，从而形成了供第一液态水供应物310离开的第一出口340。第二递送套管315的远端为敞开式，从而形成了供固态水335离开的第二出口345。在第二出口345前面，存在用于随着固态水335从第二递送套管315显现而将固态水335破碎成颗粒的研磨机(或振动器)350。出口340、345被布置成使得第一液态水供应物310和固态水颗粒混合在一起以形成冷浆料。
图5示出了用于依据使过冷水结晶来制造冷浆料的生成端115的实例。施加套管105容置用于供应过冷水410的第一递送套管405。水通常在273.15K(0℃或32℉)下冻结，但在几乎224.8K(-48.3℃/-55℉)下，水可以在标准压力下向下“过冷”到其晶体均相成核。过冷过程要求水是纯净的并且无成核位点。这可以通过比如反渗透或化学脱矿的过程来完成。使水以大约10^6K/s的速率快速地冷却会避免晶体成核，并且水变成玻璃，即，无定形(非结晶)固体。
施加套管105进一步容置用于供应冰丸420的第二递送套管415，第二递送套管415用作结晶过程的成核位点。第一递送套管405的远端为敞开式并形成供过冷水410离开的第一出口430。第二递送套管415的远端为敞开式并形成供冰丸420离开的第二出口435。出口430、435被布置成使得过冷水410与冰丸420相互作用，从而使该过冷水结晶并形成冷浆料。
图6A示出了递送点生成装置的另一个实例。该装置包含施加套管605，施加套管605在其限定出口610的远端处为敞开式。生成端615包含安置在出口610周围的外部气囊620。施加套管605与外部气囊620的内部容积进行流体连通。施加套管605包含流体递送套管625。施加套管605和流体递送套管625共享共同的纵轴并且可以说是同轴对准。
流体递送套管625在其限定流体出口630的远端处为敞开式。生成端615进一步包含安置在流体出口630周围的内部气囊635。流体递送套管625与内部气囊635的内部容积进行流体连通，该内部容积在该图中被标记为640。内部气囊635位于外部气囊620内。如所示出，内部气囊635占用外部气囊620内部容积的一部分，从而使内部气囊635的外壁(在该图中被标记为650)与外部气囊620的内壁(在该图中被标记为655)之间留有空间或间隙645。
为了在递送点处生成冷浆料，以与上文参考图1所描述的方式非常相同的方式，将施加套管605穿过患者的皮肤插入并且将生成端615推进到靶组织处或附近的位置。在这个实例中，外部气囊620和内部气囊635以它们的未充气状态插入到患者体内。然后，用例如穿过流体递送套管625供应的冷水和冷甘油的混合物的冷流体对内部气囊635进行填充或充气。
一旦内部气囊635被填充有冷流体，外部气囊620就被填充有冷却气体或流体，例如液氮。冷却气体填充内部气囊635与外部气囊620之间的间隙645。这使内部气囊635中的冷流体部分地冻结并形成冷浆料660，如图6B所示。(为了清楚起见，在图6B中未示出外部气囊620。)然后，可以使用填充有浆料的内部气囊635来使靶组织冷却。替代地，可以由可缩回的穿刺针665使内部气囊635破裂，可缩回的穿刺针665在如所示出的那样延伸时延伸到施加套管605之外。使内部气囊635破裂会将冷浆料600释放在靶组织处或附近。
图7示出了用于生成和补充冷浆料的递送点生成递送装置的另一个实例。这个实例与上文参考图6所描述的实例类似，添加了流体返回套管670。(为了清楚起见，在图7中未示出外部气囊620。)如所示出，流体返回套管670与流体递送套管625一起容置在施加套管605内。流体返回套管670从内部气囊635中移除不再处于期望温度的冷浆料。以此方式用“新鲜”冷浆料补充“旧”冷浆料可以适应于冷浆料的最终融化。这种方法对需要长时间冷却的治疗特别有用。
图8示出了具有多个套管或“工作通道”以控制上文参考图6A、图6B和图7所描述的功能的实例递送点生成装置。该装置包含施加套管705。施加套管705容置气体递送套管710、流体递送套管715和流体返回套管720，以连续地生成和补充冷浆料，如上文参考图6A和图7所描述。施加套管705还可以包含用于使被填充有冷浆料的气囊破裂的可缩回的穿刺针725，如上文参考图6B所描述。施加套管705可以进一步具有用于测量冷浆料的温度的冷浆料温度监测器730。

Claims (19)

1.一种在个体的皮肤下面的靶组织处或附近制造冷浆料的方法，所述方法包括：
将第一组分递送到个体的皮肤下面的靶组织；
将第二组分递送到所述靶组织；以及
依据所述第一组分与所述第二组分之间的相互作用在所述靶组织处或附近形成冷浆料。
2.根据权利要求1所述的方法，其中递送所述冷浆料的步骤和形成所述冷浆料的步骤是连续地进行的。
3.根据权利要求1所述的方法，其中所述第一组分是液态水并且所述第二组分是固态水。
4.根据权利要求3所述的方法，其进一步包括在所述靶组织处或附近将所述固态水破碎成固态水颗粒。
5.根据权利要求3所述的方法，其进一步包括通过在所述靶组织处或附近冻结液态水形成所述固态水。
6.根据权利要求1所述的方法，其中所述第一组分是过冷水并且所述第二组分是固态水球粒；并且
其中所述相互作用是由所述固态水球粒引起的所述过冷水的晶体成核。
7.根据权利要求1所述的方法，其中所述第一组分是容纳在内部气囊中的液态水并且所述第二组分是包围所述内部气囊并容纳在外部气囊内的冷却流体；并且
其中所述相互作用是从所述液态水到所述冷却流体的热传递。
8.根据权利要求7所述的方法，其进一步包括刺穿所述内部气囊和所述外部气囊以将所述冷浆料释放在所述靶组织处或附近。
9.一种用于在个体的皮肤下面的靶组织处或附近制造冷浆料的装置，所述装置包括：
第一套管，所述第一套管用于将第一组分递送到个体的皮肤下面的靶组织，所述第一套管包括第一敞开式远端和从所述第一敞开式远端延伸的第一纵轴；
第二套管，所述第二套管用于将第二组分递送到所述靶组织，所述第二套管包括第二敞开式远端和从所述第二敞开式远端延伸的第二纵轴，所述第二纵轴与所述第一纵轴对准；
其中所述第一敞开式远端靠近所述第二敞开式远端以用于依据所述第一组分与所述第二组分之间的相互作用在所述靶组织处或附近形成冷浆料。
10.根据权利要求9所述的装置，其中所述第一组分是液态水并且所述第二组分是固态水。
11.根据权利要求10所述的装置，其进一步包括研磨机，所述研磨机安置在所述第二敞开式远端周围以在所述靶组织处或附近将所述固态水破碎成固态水颗粒。
12.根据权利要求10所述的装置，其进一步包括振动器，所述振动器安置在所述第二敞开式远端周围以在所述靶组织处或附近将所述固态水破碎成固态水颗粒。
13.根据权利要求10所述的装置，其进一步包括第三套管，所述第三套管沿所述第二套管延伸以用于运送冷却气体以在所述靶组织处或附近由液态水形成所述固态水。
14.根据权利要求9所述的装置，其中所述第一组分是过冷水并且所述第二组分是固态水球粒；并且
其中所述相互作用是由所述固态水球粒引起的所述过冷水的晶体成核。
15.根据权利要求9所述的装置，其进一步包括：
内部气囊，所述内部气囊安置在所述第一套管的所述第一敞开式远端周围，所述内部气囊包括外表面和与所述第一套管进行流体连通以收纳所述第一组分的容积；
外部气囊，所述外部气囊安置在所述第二套管的所述第二敞开式远端周围，所述外部气囊包括内表面和与所述第二套管进行流体连通以收纳所述第二组分的容积；并且
其中所述内部气囊的所述外表面和所述外部气囊的所述内表面形成供所述第一组分与所述第二组分之间的所述相互作用发生的空间，并在所述内部气囊内形成所述冷浆料。
16.根据权利要求15所述的装置，其中所述第一组分是水和甘油的混合物；并且
其中所述第二组分是冷却气体。
17.根据权利要求15所述的装置，其进一步包括穿刺针，所述穿刺针沿所述第二套管延伸并能在延伸位置与缩回位置之间移动；并且
其中处于所述延伸位置的所述穿刺针将所述内部气囊和所述外部气囊弄破，并将所述冷浆料释放在所述靶组织处或附近。
18.根据权利要求9所述的装置，其进一步包括温度传感器，所述温度传感器延伸到所述第一敞开式远端和所述第二敞开式远端之外以测量在所述靶组织处或附近制造的所述冷浆料的温度。
19.根据权利要求9所述的装置，其中所述第一套管和所述第二套管各自具有适合于穿过所述个体的皮肤插入的大小和形状。
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