CN101528332B - 混合设备 - Google Patents

混合设备 Download PDF

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CN101528332B
CN101528332B CN200780025680.0A CN200780025680A CN101528332B CN 101528332 B CN101528332 B CN 101528332B CN 200780025680 A CN200780025680 A CN 200780025680A CN 101528332 B CN101528332 B CN 101528332B
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mixing element
combined shaft
planetary
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mixture
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CN101528332A (zh
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O·格罗伯曼
M·贝亚
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DePuy Spine LLC
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract

本发明提出一种混合设备，该设备包括a)特征为内容积不超过100毫升的混合井；b)包括位于所述混合井的内表面上的静止周向齿轮的驱动机构；和c)通过与所述静止周向齿轮啮合的混合部件齿轮驱动的行星混合部件。

Description

混合设备
技术领域
本发明涉及混合设备及混合方法。
背景技术
用于将组分混合均匀的机械混合器是公知的。它们的应用包括但不限于烘烤、房屋构建和制药。
用于高粘性混合物的混合设备必须适于提供足够的剪切力，以连续对抗很大的阻力而运动。在一些情况下，所述阻力在混合期间由于混合物的粘性增大而增大。
在混合期间混合物粘性增大的一个例子即为聚合体/单体混合物的配制。当化合聚合体和单体时，开始聚合反应。该聚合反应增大了平均的聚合物链长度和/或导致聚合物链之间的交联(或交叉耦合)。增大的聚合物链长度和/或聚合物链之间的交联导致增大的粘性。
聚合混合物经常在骨粘固剂(bone cement)的配制或配方时采用。骨粘固剂配制所采用的一个普通聚合体/单体对是聚甲基丙烯酸甲酯/异丁烯酸甲脂(PMMA/MMA)。由于PMMA/MMA骨粘固剂通常设为固体形式，通常将聚合反应的反应条件调节成PMMA和MMA的混合产生持续几分钟的液相。这通常通过将包含MMA、选择性包含DMPT和/或HQ的单体液体与包含PMMA、选择性包含硫酸钡和/或BPO和/或苯乙烯的聚合体粉末混合来获得。结果，前述可获得的混合设备构造用于液态聚合混合物，并且不能很好的适于在混合期间几乎没有液相的高粘性粘固剂的混合。
所引用下面的文献是目前可获得的用于制备骨粘固剂的混合器类型的一般指示。
专利文件US5302020、US2003/0174576、US6994465和US4961647公开了与围绕中心混合部件旋转的行星混合部件相组合的中心混合部件的使用。这些专利中的每一篇的公开内容都通过参引全部包含于此。
专利文件US5415474和US7029163公开了作为混合器的一部分的转移机构。这些专利中的每一篇的公开内容都通过参引全部包含于此。
专利文件US5549381公开了一种当混合部件从混合设备上取走时将粘附的混合物从带状构形混合部件上移走的擦拭器。这篇专利的公开内容通过参引全部包含于此。
发明内容
本发明一些实施例的广义方面涉及小批量高粘材料的混合。在本发明的示例性实施例中，“高粘性”指的是500、700或900帕/秒的粘度或更小或更大或中间粘度。确定粘度的示例性装置在Biomedical Materials Research期刊(16：219-243)中Krause等人(1982)的“The viscosity of acrylic bone cements”中描述，其内容通过参引全部包含于此。可选地，在混合开始的30、60或90秒内实现该粘度。然而，在一些情况下，该混合可能花费更长的时间。在混合完成时小的批量可以是100、50、25、15或5毫升(ml)或者更少或者中间量。
在本发明的示例性实施例中，该高粘性材料是骨填充剂或者“骨粘固剂”。可选地，该骨粘固剂包含有聚合材料，例如聚甲基丙烯酸甲酯(胶原活化酶PMMA)。可选地，该骨粘固剂是在美国专利申请文件US60/738556、US60/762789、60/765484、11/360252中的一篇或多篇中描述的类型。这些申请的公开内容通过参引全部包含于此。
本发明一些实施例的一方面涉及用于小批量高粘材料的混合器，所述混合器包含采用位于混合井(mixing well)内表面上的静止周向齿轮的驱动机构。在本发明的示例性实施例中，该静止周向齿轮驱动行星混合部件。所述行星混合部件在相对于其自身轴线转动的同时围绕混合井沿周向运行。
在本发明的示例性实施例中，行星混合部件与中心混合部件一起混合材料。在本发明的示例性实施例中，中心混合部件基本定位在混合井的中心。可选地，中心混合部件和/或行星混合部件绕它们自身轴线转动。
在本发明的示例性实施例中，行星混合部件和中心混合部件的转动的特征在于相对于它们各自轴线的不同径向速度。
在本发明的示例性实施例中，行星混合部件和中心混合部件的转动是在它们各自轴上处于相反的方向。
本发明的一些实施例的一方面涉及用于小批量粘性材料的混合器，所述混合器包括至少一个围绕基本配置在混合井的中心处的中心混合部件旋转的行星混合部件，其中混合部件的外表面之间、行星混合部件和混合并的内部之间的距离(d)基本上是相等的。
本发明的一些实施例的一方面涉及用于小批量粘性材料的混合器，其特征在于，静止周向齿轮和行星混合部件的齿轮之间的齿数比选择为在混合物上产生所预期的剪切力。
本发明的一些实施例的一方面涉及用于小批量粘性材料的混合器，其特征在于，尺寸选择为在混合物上产生所预期的剪切力的混合部件。
在本发明的示例性实施例中，对于所预期的剪切力而言，选定的齿数比随(d)增大而增大。在本发明的示例性实施例中，对于所预期的剪切力而言，选定的齿数比随混合井直径的增大而增大。
本发明的一些实施例的一方面涉及一种混合具有至少500帕/秒的粘度的小批量混合物的组分的方法，所述方法包括操作手动驱动机构来使混合部件围绕其自身轴线转动并且围绕中心混合部件旋转。
本发明的一些实施例的一方面涉及当将混合部件从混合设备取走时使用擦拭件来自动地将粘性材料与所述混合设备的至少一个混合部件分离开，由此粘性材料保留在所述设备内。在本发明的示例性实施例中，该擦拭件包括至少一个基本上与混合部件贴合的擦拭小孔。可选地，该擦拭小孔是圆的，可选地大体为圆形。在本发明的示例性实施例中，该擦拭件在驱动机构的操作期间在混合井内旋转。
本发明的一些实施例的一方面涉及一种用于将粘性材料从第一容器转移到第二容器的设备。在本发明的示例性实施例中，该设备适于与骨粘固剂一起使用。可选地，第一容器是混合井，而第二容器是注射设备的一部分。在本发明的示例性实施例中，该设备的各部件的手动操作产生足够大的力，促使特征在于粘度为500帕/秒的材料流过第一容器和第二容器之间的小孔。
根据本发明的各个实施例，小批量粘性材料的所预期的剪切力可通过改变下面的一个或多个来实现：a)混合井内和/或混合部件上的内表面的粗糙度，以产生边界层；b)表面之间的距离，其中较小的距离对增大剪切力起作用；c)混合部件的表面和/或混合井的表面的相对速度。
相对速度可选地受尺寸、齿数比、混合部件的驱动速度和转动速度中的一个或多个的影响。
在本发明的示例性实施例中，提供有一种混合设备，该设备包括：a)特征为内容积(或内部空间)不超过100毫升(ml)的混合井；b)包括位于混合井的内表面上的静止周向齿轮的驱动机构；和c)由与静止周向齿轮啮合的混合部件齿轮驱动的行星混合部件。可选地，该驱动机构适于为混合其特征为粘度至少是500帕/秒的混合物提供足够大的剪切力。可选地，至少为500帕/秒的粘度在混合开始的90秒内实现。可选地，该设备包括：d)可与混合并接合并且适于将其关闭的盖体。可选地，该盖体包括锁定环。可选地，该驱动机构适于手动操作。可选地，该设备包括：d)适于同时与混合井的内表面和行星混合部件接合的擦拭件。可选地，该设备包括：d)基本上设置在混合井的中心处的中心混合部件。可选地，该设备包括：e)适于同时与混合井的内表面、行星混合部件以及中心混合部件接合的擦拭件。可选地，该中心混合部件围绕其自身轴线转动。可选择，该中心混合部件和行星混合部件沿相反方向转动。
在本发明的示例性实施例中，提供有一种混合设备，该设备包括：a)特征为内容积(或内部空间)不超过100毫升(ml)的混合井；b)适于操作设置在混合井内的至少一个混合部件的驱动机构；和c)适于与混合井的内表面接合并且包括至少一个基本上与该至少一个的混合部件相符的擦拭小孔的擦拭件；其中该擦拭件不干扰驱动机构的操作；和其中该至少一个的混合部件从混合井的收回导致该至少一个的擦拭小孔将混合物的至少一部分从该至少一个混合部件移走。可选地，该擦拭件在混合井内转动，同时与其内表面接合。可选地，该驱动机构适于为混合特征为粘度至少是500帕/秒的混合物提供足够大的剪切力。可选地，该设备包括：d)可与混合井接合并且适于将其关闭的盖体。可选地，该盖体包括锁定环。可选地，至少为500帕/秒的粘度在混合开始的90秒内实现。可选地，该擦拭件适于将特征是粘度至少为500帕/秒的混合物的粘附部分从该至少一个的混合部件移走。可选地，该至少一个混合部件包括至少两个混合部件。可选地，该驱动机构适于手动操作。
在本发明的示例性实施例中，提供一种混合设备，该设备包括：a)特征为内容积不超过100毫升(ml)的混合井；b)基本上在该混合井的中心处配置的中心混合部件；c)至少一个围绕该中心混合部件转动的行星混合部件；其中该中心混合部件和该行星混合部件之间的第一距离(d1)基本上与该行星混合部件和该混合井的内表面之间的第二距离(d2)相等。可选地，该驱动机构适于手动操作。可选地，该驱动机构适于为混合特征为粘度至少是500帕/秒的混合物提供足够大的剪切力。
在本发明的示例性实施例中，提供有一种用于混合设备的驱动机构，该驱动机构包括：a)限定特征在于不超过100毫升(ml)的内容积的容器的内周边上的圆形路径的一组齿；b)特征为轴线的齿轮，该齿轮适于与所述组的齿啮合并且围绕该轴线转动；和c)适于提供导致所述齿轮沿该圆形路径前移的力的致动器。可选地，该机构包括：d)连接在该齿轮的轴线和基本设置在该圆形路径的中心处的第二轮之间的驱动转移部件。可选地，通过致动器所提供的力导致该驱动转移部件围绕穿过圆形路线的中心的轴线转动所述第二轮。可选地，该齿轮驱动行星混合部件。可选地，第二轮驱动中心混合部件。可选地，致动器手动驱动。可选地，该机构适于为混合特征为粘度至少是500帕/秒的混合物提供足够大的剪切力。
在本发明的示例性实施例中，提供有一种混合粘性混合物的组分的方法，该方法包括：a)将组分放置在特征为内容积不超过100毫升(ml)的混合井内；b)将至少一个行星混合部件和中心混合部件配置在混合井内；和c)操作手动驱动机构来使行星混合部件围绕其自身轴线转动并且围绕该中心混合部件转动，以便混合组分从而形成混合物。可选地，该方法包括：e)将擦拭件接合到至少一个混合部件，由此混合部件从混合井的收回使得该擦拭件将混合物从该混合部件擦去。可选地，该驱动机构适于为混合特征为粘度至少是500帕/秒的混合物提供足够大的剪切力。可选地，至少为500帕/秒的粘度在混合开始的90秒内实现。可选地，该手动驱动机构提供足够大的力来促使该行星混合部件移动穿过特征在于粘度至少为500帕/秒的混合物。
在本发明的示例性实施例中，提供有一种用于转移粘性材料的设备，该设备包括：a)能够容纳粘性材料的第一容器；b)可插入到第一容器内的转移活塞，由此该活塞相对于该容器形成周向密封，该转移活塞包含有孔；和c)用于将第二容器的小孔附接到转移活塞内的孔的机构；其中转移活塞向第一容器的插入导致粘性材料穿过该小孔进入到第二容器内。可选地，该设备适于提供促使特征在于粘度至少为500帕/秒的混合物流过第二容器的小孔的足够大的力。可选地，该设备构形成使得第一容器和转移活塞的手动操作产生足够大的力。可选地，该转移活塞适于在将混合部件从第一容器移走时将粘性材料的至少一部分从混合部件移走。
在本发明的示例性实施例中，提供有一种混合粘性混合物的组分的方法，该方法包括：a)将组分设置在特征为内容积不大于100毫升(ml)的混合井内。b)操作驱动机构，促使当粘度为至少500帕/秒期间内的材料在内容积内的混合。
可选地，该方法包括通过驱动机构驱动行星混合部件。
附图说明
参考附图阅读下文说明中所描述的本发明的示例性的非限定性实施例。在附图中，其中在多于一副附图中出现的相同和相似的结构、部件或零部件在它们所出现的附图中通常被标以相同或相似的附图标记。附图中所示的构件和特征的尺寸的选取主要是为了方便和清楚的表述，并非一定依比例来确定。在附图中：
图1是简化的流程图，图示出了与根据本发明的示例性实施例的混合设备的使用相关联的事件的示例性顺序；
图2是将混合部件从混合井移走的示例性混合设备的透视图；
图3是组装的混合器的局部剖视图，显示了示例性驱动机构的一部分；
图4A和4B是示意图和工程投影图，分别显示了示例性驱动机构的转动方向和距离；
图5是图表，显示了根据本发明示例性实施例的行星混合部件和中心混合部件之间的剪切应力梯度；
图6、7和8显示了适于与示例性混合设备一起使用的示例性擦拭件；以及
图9和10显示了适于与示例性混合设备一起使用的转移模块。
具体实施方式
概述
美国专利申请文件60/738556、US60/762789、US60/765484和11/360251(下文称为“发明人的先前申请”)公开了聚合骨粘固剂配制或配方(formulation)，其以向高粘状态的快速转变为特征，上述申请文件的每一篇的公开内容全部包含于此作为参考。根据在这些申请文件中公开的示例性粘固剂配制，基本上聚合体一旦被单体湿润或弄湿，单体和聚合体组分的混合就会生成特征为具有400到500帕/秒(Pascal/second)范围的粘度的混合物。在实践中，这仅花费30秒。
前述可获得的骨粘固剂配制的特征为相对长的液相和短的工作窗口(working window)，在此期间，粘固剂适合于喷射。本发明人的先前申请中所公开的新的一类(new class)的粘固剂配制的特征为，在粘固剂开始固化之前在长久的液相后没有继之以相对长的工作窗口的情况下向高粘度的快速转变。发明人的先前申请中所公开的新一类的粘固剂配制中向高粘度的几乎是即刻转变意味着为了确保完全混合，期望的是大的剪切力。对于这种新一类的粘固剂配制而言，由于基本上没有液态，当混合物仍旧处于液态时混合组分是不可行的。
由于通常以小批量(例如5、10、20、30、40、50毫升(ml)或者更少或更多或中间量)来制备骨粘固剂，发明人的先前申请中的新型粘固剂的配制对骨粘固剂混合设备提出了新的制约。
根据本发明的示例性混合设备也可采用常规的骨粘固剂的配制。可选地，可在聚合反应已经进行到液相阶段之后并实现了400、可选择地500帕/秒或者更小或者更大或者中间粘度的粘度之后使用根据本发明的示例性混合设备。可选地，根据本发明的示例性混合设备可通过调节混合部件之间的距离用来混合液态混合物。可选地，根据本发明的示例性混合设备可用来在混合物的粘度达到至少100帕/秒之后，混合根据前述已知的配制方式制备的粘固剂。
图1是简化的流程图，其图示出了与根据本发明的示例性实施例的一种方法100相关联的实施过程的顺序。
在步骤110，组分被放置到混合井内或者混合设备的混合井中。可选择的是，这一操作可作为设备200的制造程序的一部分进行实施。
可选地，在步骤120配置一个或多个擦拭件。这些可配置在混合井内或者盖体上和/或混合设备的混合部件上进行，并且可在将所述部件放置在混合井内于步骤100之前或之后进行。
在步骤130，将混合部件插入到混合井中，使得它们至少部分浸没于混合物的组分中。如果擦拭件已经配置在步骤120，在这个阶段混合物的组分通常位于擦拭件下方。
操作驱动机构，以便在步骤140处混合组分。如上所述，根据本发明的示例性实施例，在步骤140的混合将导致组分在相对较短的时间内，可选地在几秒之内，形成高粘性混合物。在本发明的示例性实施例中，在已形成高粘度混合物后，通过在步骤140的连续混合实现骨粘固剂的符合要求的制备。可选地，驱动机构的操作是手动的和/或通过马达或通过压缩空气或通过现有技术中已知的其他外部力量源来驱动。
在步骤140完成混合后，移走混合部件步骤150。如果在步骤120已经配置了擦拭件，在这个阶段进行混合部件的自动擦拭步骤152。可选地，在移走步骤150期间和/或之后擦拭件保持在混合井内。
可选地，在步骤160将粘固剂从混合井直接转移到喷射容器中。可选地，使用包括本发明的示例性实施例的转移设备在步骤160完成转移。
示例性设备
图2、3、6、7和8显示了根据本发明的混合设备200的示例性实施例。
图2示出了带有从底座或底架250移去的盖体220的示例性设备200。盖体200显示为带有可选的锁定环224，所述锁定环与底座250的一组螺纹256配合。
在本发明的一些示例性实施例中，在这个阶段，在步骤110将组分放置于混合井252内。
在本发明的其它实施例中，作为制造和装配过程的一部分，将组分在步骤110放置在混合并252内。可选地，如图3所示，为设备200提供原料并装配。当为设备200提供原料并装配且混合组分位于其内部时，可通过多种方法来阻止单体液体和聚合粉末的不希望的过早混合。防止不希望的过早混合的示例方法在下文中描述。
盖体220包括驱动机构的多个部分。所述驱动机构是可选的通过手柄210操作的手动机构。在图示的实施例中，盖体220包括构形成借助于接合臂262与擦拭件260接合的面向下的突起222(图6)。
在图示的示例性实施例中，接合臂262B主要起与突起222接合的作用。
在另一示例性实施例中，接合臂262A起与突起222接合的作用，并且与底座250内的凹槽264接合。接合臂262A和底座250内的凹槽264的关系在下文中描述。
可以看到中心混合部件230和行星混合部件240从盖体220向下突伸。可选地，设置两个或多个行星混合部件240。在这个视图中行星驱动齿轮270的一部分也是可见的。
底座250包括内部混合井252和一系列面朝内的用作静止周向齿轮254的齿。静止周向齿轮254是驱动机构的一部分，并且构形成当盖体220与底座250装配在一起时所述静止周向齿轮与行星驱动齿轮270啮合。
图3是组装的设备200的局部剖视图，更加详细的图示出驱动机构。在这个视图中在步骤130插入混合部件230和240，并且在步骤120可选的擦拭件已经配置在图示的实施例中。行星驱动齿轮270定位在行星混合部件240的中心轴上方，并且连接到其上，使得混合部件240运行和/或与齿轮270一起转动。齿轮270通过座放于盖体220的驱动轴承座(receptacle)274内的驱动轴联接于盖体220。行星齿轮270的齿在底座250的混合井252内与静止周向齿轮254的互补的齿啮合。所述行星混合部件240通过驱动部件232联接于中心混合部件230。擦拭件260同时与混合井252的内表面以及混合部件230和240接合。
驱动机构的操作，例如通过手柄210的转动，致使盖体22相对于底座250转动。这使得行星驱动轴272沿与混合井252的内壁同心的圆形路径前进。行星齿轮270与静止周向齿轮254啮合，使得当行星驱动轴272和行星混合部件240沿它们的圆形路径前进时行星齿轮270转动行星混合部件240。在本发明的示例性实施例中，驱动部件232联接于行星混合部件240和中心混合部件230。可选地，当行星混合部件240前进时，驱动部件232引起中心混合部件230转动。在本发明的其它实施例中，所述中心混合部件230不转动。当混合部件240前进时，在步骤140发生混合。
图4A是从底座250上方看去的示例性驱动机构的示意图。这个视图中可比前面的视图更加清楚的看出行星齿轮270、行星驱动轴272、中心混合部件230、静止周向齿轮254和驱动部件232(此处图示为杆)之间的物理或实际关系。
驱动机构的工程考虑因素在下文中讨论。在本发明的示例性实施例中，静止周向齿轮254具有三倍于所述行星驱动齿轮270的齿。
混合部件230和240是选择性粗糙的、锯齿状的或者有条纹的，以确保在混合期间临近混合部件的表面正混合的材料内边界层的形成。可选择的是，井252的内表面是相似的粗糙的、锯齿状的或者有条纹的，以确保靠近井表面的边界层的形成。
在本发明的示例性实施例中，锯齿呈现沿混合部件230和/或240的整个高度延伸的垂直切口的形式。可选地，该纵向的切口有助于混合部件230和/或240穿过擦拭件260内的擦拭小孔很容易的引入和取出。可选地，垂直切口的特征为具有0.1、0.5或1毫米(mm)或更少或更多或中间的深度。
示例性驱动机构工程考虑因素
图4B是工程投影图，分别示出了示例性驱动机构的转动方向和距离；正如图4A，这个视图俯视底座250。
在操作期间，中心混合部件230的外表面上的点“A”将以径向速度V(A)逆时针(箭头)移动：其中是单位为弧/秒的混合部件230的转动速度，而R1是混合部件230的半径。
在操作期间，行星混合部件240的面上的点“B”将具有径向速度V(B)，其包括由于行星混合部件240相对于中心混合部件230的轴线转动产生的速度与由于所述行星混合部件240在其自身轴线上的转动产生的速度之和：其中其中“i”是静止周向齿轮254的齿数与行星齿轮270的齿数之比；而是混合部件230的转动速度；R(B)是从混合部件230的中心到混合部件240上的最近点(B)的距离；和R2是混合部件240的半径。
在操作期间，行星混合部件240的相对表面上的点“C”将具有径向速度V(C)，其包括由于混合部件240相对于中心混合部件230的轴线转动产生的速度与由于行星混合部件240在其自身轴线上的转动产生的速度之差：其中R(C)是从混合部件230的中心到混合部件240上的最远点(C)的距离；其余项正如上面所定义的。
静止周向齿轮254上的点D将具有零速度。
在点A和B之间或者点C和D之间流动的混合物上的剪切力或剪切应力可以通过相对点之间的径向速度的减法(速度梯度)来计算：固定的位置和行星混合部件之间的剪切力与下面的公式相关：
行星混合部件到静止混合室内表面之间的剪切力与下面的公式相关：
在本发明的示例性实施例中，设备200手动操作，因此由操作者设定可选地，可以是10、15、22或30RPM或者更小或者更大或者中间值。
在本发明的示例性实施例中，选择R1、R2、R(B)、R(C)和i以便满足几何考虑因素和相对相似的速度梯度，考虑到选定的速度例如500帕/秒，其足以产生足够的剪切应力。
图5图示出施加到在两个部件(例如行星混合部件240和中心混合部件230、或行星混合部件240和混合井254的内壁)之间流动的混合物500上的剪切力的理论梯度。随着混合物500的粘度的增大，用于混合所需的剪切力也增大。
在本发明的示例性实施例中，用于混合以500帕/秒的粘度为特征的混合物500的足够的剪切力通过将两个混合部件(图4B中的A到B)、或者行星混合部件240和混合井254的内壁(图4B中C到D)之间的距离调节到1到5mm、可选地大约为2mm来提供。
可选择地或者另外地，通过改变混合部件230和/或240的表面区域和/或与混合物接触的井252的内表面来调节剪切力。
擦拭件
图6、7和8图示出根据本发明的示例性实施例的可选擦拭件260的设置和功能。
图6显示了借助于接合臂262A和262B与面朝下的突起222接合的擦拭件260。在这个阶段混合井252的周向凹槽264是空的。混合部件230和240穿过擦拭件260上的擦拭小孔突伸。
图7示出了装配在底座250上的盖体220，从而擦拭件230和240紧密地靠近混合井252的底板258。擦拭件260的接合臂262座落于混合井252的凹槽264内(为了清晰起见在插图中放大了)。随着行星混合部件240围绕混合井252的运行，每一个接合臂262围绕混合井252在凹槽264内周向上滑动。
图8图示出在步骤150将混合部件230和240从混合井252中的移走。接合臂262由凹槽264保持，使得擦拭件被锁定到位。部件230和240的移走导致在步骤152通过擦拭小孔的边缘而自动擦拭。
转移机构
图9和10图示出在共同未决的美国专利申请11/360251中前述公开的根据本发明示例性实施例的转移机构，所述公开内容全部包含于此用作参考。图9是剖视图，而图10是立体的局部切口视图。
图9和10图示出包含插入到混合井254内的转移活塞座(cup)950的示例性转移部件900。在图示的实施例中，活塞座950的螺纹956与底座250的螺纹256接合。在转移活塞座950旋接到底座250上时，迫使转移活塞座950的底板(或底面)958向下并朝着混合井252的底板(或底面)258。这个动作在擦拭件260上施加向下的压力。这个向下的压力使得接合臂292被从凹槽264释放。一旦接合臂262被释放，擦拭件260能够自由的朝着混合井252的底板258向下运行。可选地，擦拭件260还用作将混合物推入到注射贮液器910中的活塞。
在图示的实施例中，转移活塞座950配备有与注射贮液器910上的相匹配的螺纹930接合的第二组螺纹952。在操作中，在转移活塞座950插入到混合井252之前，注射贮液器910通过螺纹930和952接附到转移活塞座950上。随着转移活塞座950下降到混合井252内，混合井252内的内容物(例如高粘度骨粘固剂)被向上推送到注射贮液器910中。注射喷嘴920用来将空气从注射贮液器910释放，由此不存在抵抗压力的累积。在这个阶段，在步骤160已将混合的材料转移到注射装置。可选地，当骨粘固剂离开注射喷嘴920时，该设备的操作者获知贮液器910是充满的。示例性尺寸
根据本发明的不同示例性实施例，混合井252的内容积是5、可选地10、可选地20、可选地40、可选地60、可选地80、可选地100毫升(ml)或者更多或者中间值。在本发明的示例性实施例中，混合井容积或体积为50到60毫升(ml)、可选大约66毫升(ml)，并且将混合物中的10到20毫升(ml)、可选混合物中的大约15毫升(ml)设置在腔室内用于混合。在本发明的示例性实施例中，所述井252的内容积的一部分被混合部件230和240占据。
可选地，混合井的内径为20、可选地40、可选地60、可选地80、可选地100毫米(mm)或者更小或者更大或者中间尺寸。在本发明的示例性实施例中，混合井的内径为40到50毫米(mm)，可选大约46毫米(mm)。
可选地，混合井的高度是20，然而它可以是40、60、80或者100毫米(mm)或者更小或者更大或者中间尺寸。在本发明的示例性实施例中，混合井的高度是35到45毫米(mm)，可选为大约40毫米(mm)。
可选地，混合井的宽高比(直径/高度)是0.7、0.9、1.1或者1.3或者更小或者更大或者为中间值。在本发明的示例性实施例中，混合井的宽高比(直径/高度)是1.1到1.2，可选为大约1.15。
在本发明的示例性实施例中，中心混合部件和行星混合部件(在图4A中由A到B指示)之间的距离(d1)和/或行星混合部件和混合井的内壁(在图4A中由C到D指示)之间的距离(d2)是1、2、3、4或5毫米(mm)或者更小或者更大或者中间距离。在本发明的示例性实施例中，d1基本上等于d2。
在常规的椎骨治疗手术中，大约5毫升(ml)的含量被注射到单个椎骨内。如果要注射单个椎骨的话，通常制备大约85毫升(ml)批量的粘固剂，如果要注射两个椎骨的话，大约155毫升(ml)的粘固剂，如果要注射三个或更多椎骨的话，制备累进的更大的量。当聚合体被单体湿润时，粉末的聚合组分和液态单体组分的组合导致总的混合物量的减少。例如，40到505毫升(ml)的聚合体粉末可与7到95毫升(ml)的单体液体混合112，以生成185毫升(ml)的聚合粘固剂。在本发明的示例性实施例中，井252的容量选定为容纳单体粉末的大的原始柱，即使是在制备特别小批量粘固剂时。
在本发明的示例性实施例中，在通过转移部件900转移到注射贮液器910之后，存留在井242内的固定容量小于2、1或者0.55毫升(ml)或者更少或者中间值。
在本发明的示例性实施例中，中心混合部件230的直径和注射贮液器910的直径都与擦拭件260的孔的直径相等。可选地，直径的这种一致性减少了转移设备900的操作后留在井252内的粘固剂的固定量。可选地，直径都是大约185毫升(ml)。
在本发明的其它实施例中(图中未示)，将底座250的混合井252转移到注射设备，并且将粘固剂直接从井252注射到主体(subject)上。可选地，这发生在将混合部件230和240取走之后。
示例性材料
在本发明的示例性实施例中，混合设备的组分部分由聚酰胺(例如尼龙)和/或聚丙烯构造。
可选地，该设备的某些部分由金属例如不锈钢构造成。在本发明的示例性实施例中，采用金属来构造承受很大的力例如摩擦或扭矩的零部件。可选地，手柄210、齿轮例如270、齿例如254、驱动臂例如232和混合部件例如230和/或240中的一个或多个由金属构造。示例性使用方法
在本发明的示例性实施例中，设备200设有用法说明。在本发明的示例性实施例中，该说明指示了实现放置在井252内的混合物的完全混合的步骤。
可选地，这些说明指示确保完全混合所推荐的时间。在本发明的示例性实施例中，时间是30到90秒，可选地30到60秒，可选地大约45秒或者更少或者更多或者中间时间量。
可选地，这些说明指示了确保完全混合所推荐的转动或翻转数量。在本发明的示例性实施例中，转动数量是20到100，可选40到60，可选大约50或者更少或者更多或者中间量。
可选地，这些说明指示了当混合完成时呈现给使用者的信号。该信号可以是视觉信号(例如指示灯)或者听觉信号(例如蜂鸣器或钟)或者触觉信号(例如当实现预期粘度时齿轮270在齿254上滑动)。在本发明的示例性实施例中，该信号通过闭合反馈回路触发。该回路可依赖于例如粘度的间接测量(例如扭矩)、向心力、时间、设备200的一部分(例如手柄210、齿轮270或者混合部件230和/或240)的回转数或者混合物的量。
可选地，该设备与仅在时间和/或转数的预设窗口期间容许手柄转动的机构结合。
剪切力考虑因素
井252内的混合物上的前切力主要受表面属性、表面间的距离和表面间的速度差值的影响。
混合部件230、240以及井252的内表面的表面属性全都影响在混合物500(图5)上所施加的剪切力。增大的粗糙度(例如通过锯齿或条纹)通过增大的摩擦力来防止混合物500在这些表面上的滑动。当表面足够粗糙时，边界层相对于该表面具有零相对速度。可选地，这个零相对速度对增大的剪切力起作用。
表面之间的距离与作用在所述表面之间移动的混合物500上的剪切力成反比(inversely related)。在本发明的示例性实施例中，当由线条A-B和/或C-D(图4B)所限定的距离增大时，施加到穿过这些线条的混合物的一部分的剪切力减小。
混合器200的各部分之间的相对速度的差值也影响混合物200上的剪切力。当相对速度的差值增大时，施加到在所述部件之间流动的混合物500的一部分上的剪切力增大。所述相对速度可选地受如上文详细讨论的所涉及的角速度和/或径向速度和/或所述部件的半径的影响。在本发明的示例性实施例中，通过将具有不同方向的角速度传给混合部件240和230，相对速度的差值被放大。概要
由于骨粘固剂混合物的一些组分可能具有不愉快的气味和/或如果吸入的话是有毒的，本发明的一些示例性实施例包含有减少暴露于不希望的蒸汽的安全构造(或结构或者特征)。
在本发明的示例性实施例中，锁定环224装备有防止蒸汽从井252中逸出的气密性密封件(例如橡胶或硅)。
可选地或者附加地，设备200可设有可连接到真空源的排气口(图中未示)。在本发明的示例性实施例中，真空源是在医院手术室内的标准“壁面吸气”单元，且不希望的蒸汽是来自骨粘固剂混合物的MMA组分。
在向设备200提供需要在井252内部混合的组分的情况下，可实施防止不希望的过早混合的方法。
防止单体液体和聚合体粉末的不希望过早混合的一个示例性方法是要提供密封包或胶囊内的单体液体，所述密封包或胶囊在操作设备200时破裂。所述胶囊在它通过混合物500的流动而被牵引穿过线A-B或C-D时破裂。在本发明的示例性实施例中，所述胶囊设计成使得它的特征为超过A-B和/或C-D的长度的最小尺寸。在本发明的示例性实施例中，所述包或胶囊由可与骨粘固剂一起喷射的生物兼容材料构成。
防止单体液体和聚合体粉末的不希望过早混合的另一示例性方法是要提供在中心混合部件230内部的单体液体。可选地，将盖体220从底座250的部分移除使得单体液体可从混合部件230出来进入到井252中。可选地，锁定环224的紧固打破了混合部件230内的密封。密封的打破将液态单体释放到粉末组分上。
防止单体液体与聚合体粉末的不希望过早混合的另一示例性方法是提供位于混合井252的壁内部的空腔内的单体液体。可选地，当混合开始时，空腔内的内容物手动或自动地倾卸到井252中。
已经利用通过示例提供而非试图必须限制本发明的范围的本发明的实施例的详细说明描述了本发明。特别地，数值可以高于或低于上述的数值范围，但仍旧落入本发明的范围内。所描述的实施例包括不同构造或特征，在本发明的所有实施例中并非所有的构造或特征都是必需的。本发明的一些实施例仅采用其中一些构造特征或者这些构造或特征的可能组合。可选地或者另外地，描述/描绘为单个单元的本发明的各部分可存在于两个或多个分开的机构，其相应的实现所描述/描绘的功能。可选地或者另外地，描述/描绘为两个或多个分开的机构的本发明的各部分可集成为单个机构，以实施所描述/描绘的功能。所描述的本发明的实施例的变形以及包括所述实施例中所记录构造或特征的不同组合的本发明的实施例可以以所有可能的组合进行组合，包括但不限于在任意其它实施例中使用在一个实施例上下文中所描述的构造或特征。本发明的范围仅通过下文的权利要求书来限定。
在本发明的说明书和权利要求书中，每个动词“包括”、“包含”和“具有”以及它们的任意变化都用于指示所述动词的宾语不一定包括该动词宾语的部件、组件、部件或零部件的完整名单。
在本文件中所引用的所有出版物和/或专利文件和/或产品说明书通过参引全部包含于此，正如每一个都通过参引单独包含于此一样。

Claims (25)

1.一种混合设备，所述设备包括：
a)特征为内容积不超过100毫升的混合井；
b)包含有位于所述混合井的内表面上的静止周向齿轮的驱动机构；
c)通过与所述静止周向齿轮啮合的混合部件齿轮驱动的行星混合部件；以及
d)基本定位在所述混合井的中心处的中心混合部件；
其中，所述行星混合部件围绕所述中心混合部件旋转，并且所述行星混合部件和所述中心混合部件在所述混合井内间隔开并且大小定制成使得与所述驱动机构接合在所述中心混合部件和所述行星混合部件之间的空间以及在所述行星混合部件与所述混合井的所述内表面之间的空间中为混合特征在于粘度为至少500帕/秒的混合物提供足够大的剪切力。
2.根据权利要求1所述的设备，其特征在于：至少为500帕/秒的粘度在混合开始的90秒内实现。
3.根据权利要求1所述的设备，其特征在于，其包括：
e)可与所述混合井接合并且适于将其关闭的盖体。
4.根据权利要求3所述的设备，其特征在于：所述盖体包括锁定环。
5.根据权利要求1到4中任一项所述的设备，其特征在于，其包括：适于同时与所述混合井的内表面和所述行星混合部件接合的擦拭件。
6.根据权利要求1到4中任一项所述的设备，其特征在于：所述驱动机构适于手动操作。
7.根据权利要求1所述的设备，其特征在于，其包括：适于同时与所述混合井的内表面、所述行星混合部件和所述中心混合部件接合的擦拭件。
8.根据权利要求1所述的设备，其特征在于：所述中心混合部件围绕其自身轴线转动。
9.根据权利要求8所述的设备，其特征在于：所述中心混合部件和所述行星混合部件沿相反方向转动。
10.一种混合设备，所述设备包括：
a)特征为内容积不超过100毫升的混合井；
b)基本在所述混合井内的中心处配置的中心混合部件；
c)至少一个围绕所述中心混合部件旋转的行星混合部件；
其中，所述中心混合部件和所述行星混合部件之间的第一距离(d1)基本上与所述行星混合部件和所述混合井的内表面之间的第二距离(d2)相等。
11.根据权利要求10所述的设备，其特征在于：所述行星混合部件适于手动操作。
12.根据权利要求10或11所述的设备，其特征在于：所述行星混合部件和所述中心混合部件适于为混合特征在于粘度为至少500帕/秒的混合物提供足够大的剪切力。
13.一种用于根据权利要求1-12中任一项所述的混合设备的驱动机构，所述驱动机构包括：
a)在特征为内容积不超过100毫升的容器的内周边上限定圆形路径的一组齿；
b)特征为轴线的齿轮，所述齿轮适于与所述组的齿啮合并且围绕所述轴线转动；和
c)适于提供导致所述齿轮沿所述圆形路径前移的力的致动器。
14.根据权利要求13所述的机构，其特征在于，其包括：
d)连接在所述齿轮的轴线和基本设置在所述圆形路径的中心处的第二轮之间的驱动转移部件
15.根据权利要求14所述的机构，其特征在于：所述第二轮驱动中心混合部件。
16.根据权利要求14所述的机构，其特征在于：通过致动器所提供的力导致所述驱动转移部件围绕穿过所述圆形路线的中心的轴线转动所述第二轮。
17.根据权利要求13到16中任一项所述的机构，其特征在于：所述齿轮驱动行星混合部件。
18.根据权利要求13到16中任一项所述的机构，其特征在于：所述致动器手动驱动。
19.一种操作根据权利要求1-12中任一项所述的混合设备的方法，所述方法包括：
a)将组分放置在特征为内容积不超过100毫升的混合井内；
b)将至少一个行星混合部件和中心混合部件配置在所述混合井内；和
c)操作手动驱动机构来促使所述行星混合部件围绕其自身轴线转动并且围绕所述中心混合部件旋转，以便混合所述组分从而形成混合物。
20.根据权利要求19所述的方法，其特征在于，其包括：
d)将擦拭件接合到至少一个所述混合部件，从而所述混合部件从所述混合井的移走使得所述擦拭件将混合物从所述混合部件擦去
21.根据权利要求19或20所述的方法，其特征在于：所述驱动机构适于为混合特征在于粘度为至少500帕/秒的混合物提供足够大的剪切力。
22.根据权利要求19或20所述的方法，其特征在于：至少为500帕/秒的粘度在混合开始的90秒内实现。
23.根据权利要求19或20所述的方法，其特征在于：所述手动驱动机构提供足够大的力来促使所述行星混合部件移动穿过特征在于粘度至少为500帕/秒的混合物。
24.一种操作根据权利要求1-12中任一项所述的混合设备的方法，所述方法包括：
a)将组分放置在特征为内容积不大于100毫升的混合井内；
b)操作根据权利要求13-18中任一项所述的驱动机构，促使当粘度为至少500帕/秒时的期间内材料在所述内容积内的混合。
25.根据权利要求24所述的方法，其特征在于，其包括通过所述驱动机构驱动行星混合部件。
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