CN101791450A - 用于向骨髓中注射的装置和方法 - Google Patents
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Abstract
一种用于向骨的骨髓输送一定量流体的装置,包括:柱塞运行和药筒驱动机构;和具有流体贮存器和骨穿透针的药筒组件。
Description
本分案申请是基于申请号为200680021872.X、申请日为2006年6月27日、发明名称为“用于向骨髓中注射的装置和方法”的中国专利申请的分案申请。
技术领域
本发明涉及用于把流体输送到目标位置例如但不限于骨的骨髓并把流体从目标位置移走的装置和方法。
背景技术
每年,在美国数百万的病人因为威胁生命的紧急情况而被治疗。这样的紧急情况包括休克、外伤、心搏停止、服药过量、糖尿病酮酸中毒、心律不齐、烧伤和癫痫,仅仅列举一部分。例如,根据美国心脏协会,每年超过1,500,000的病人遭受心脏病发作(心肌梗塞),其中超过500,000死于毁灭性并发症。
处理所有这样的紧急情况的必须的要素是迅速建立静脉线路(IV)以配送药品和流体直接进入循环系统。不管是救护车内的护理人员或者是急诊室里的急诊专家,目标是一样的,即启动IV以配送救命的药品和流体。在很大程度上,成功处理这样的危急紧急情况的能力取决于操作人员建立血管通道的技术和运气。虽然在一些病人身上启动IV相对容易,在大约20%的病人身上建立IV通道时医生、护士和护理人员通常经历巨大困难。需要利用尖的针反复探查这些病人,以尝试解决这个问题,并可能需要侵害程序以最终建立静脉进入。
建立IV通道的另一个复杂的因素出现在“现场”,例如在事故现场或在救护车运输途中,此时很难看到目标而且过多的运动使得进入静脉系统很困难。
在病人具有慢性病或年老的情况下,容易进入的静脉的可获得性被耗尽。另一些病人由于外表静脉的解剖性缺乏、肥胖、极度脱水或以前的IV药物使用而不具有可获得的IV位置。对于这些病人,找到用于配送救命药的合适位置成为意义重大而且令人受挫的任务。虽然发病率和死亡率的统计不是通常能获得的,众所周知具有威胁生命的紧急情况的许多病人死于随继发生的并发症,因为用于救命的IV治疗的进入血管系统被延迟或简直不可能。对于这样的病人,需要替换的方法。
发明内容
根据本公开的教导,提供了可用于把一定量流体输送到目标位置例如骨的骨髓的装置。该装置可包括驱动器、柱塞运行和药筒驱动机构以及药筒组件,该药筒组件具有流体贮存器,骨穿透针连接于药筒组件上。
在另一个实施例中,用于把一定量药品输送到目标位置的装置可包括驱动器、具有第一弹簧的柱塞运行组件或者柱塞套、具有第二弹簧的伸缩套筒以及连有骨穿透器的流体贮存器。
在另一个实施例中,提供了用于把一定量流体输送到骨的骨髓的装置,该装置可包括动力驱动器,其具有用于与柱塞运行和药筒驱动机构相连接的钻轴、用于接合并旋转钻轴的齿轮传动装置、马达、用于供给马达动力的动力源和关联的线路。柱塞运行和药筒驱动机构包括柱塞运行组件和伸缩式套筒。具有流体贮存器的药筒组件以及柱塞组件和骨穿透针可以可释放地与柱塞运行和药筒驱动机构接合在一起。
在另一个实施例中,提供一种用于把一定量药物输送到目标位置例如但不限于骨的骨髓的方法,其包括将一部分柱塞运行和药筒驱动机构压缩或准备击发,把充满流体的药筒组件插入待击发的柱塞运行和药筒驱动机构,并刺入骨髓直到柱塞运行和药筒驱动机构把一定量流体注入骨髓为止。
在又一实施例中,用于把药物输送到骨的骨髓的药筒组件可具有可拆的流体贮存器、柱塞组件、骨穿透针和相关配件。流体贮存器可以至少部分地由玻璃、玻璃复合物、塑料或塑料复合物形成。
对于一些实施例,骨穿透针可包括中空的纵向孔,在纵向孔一端具有封闭尖端。与骨穿透针的纵向孔相连通的侧口可以成角度,以阻断或利于特定物质的通过。
附图说明
通过参考下面结合附图的描述,可以获得本发明实施例及其优点的更加完整和彻底的理解,其中类似的附图标记表示类似特征,其中:
附图1A是立面示意图,其显示了用于把一定量药物输送到骨髓的装置的一个实施例;
附图1B是部分分离的横截面和立面的分解示意图,其显示了在空载、待击发位置的用于把一定量药物输送到骨髓的装置的一个实施例;
附图1C是部分分离的横截面示意图,其显示了在装载位置的用于把一定量药物输送到骨髓的装置的一个实施例;
附图1D是部分分离的横截面示意图,其显示了在第三、释放位置的用于把一定量药物输送到骨髓的装置的一个实施例;
附图1E是部分分离的横截面和立面的示意图,其显示了根据本公开的教导的与骨髓连通的骨穿透器;
附图1F是部分分离的等距示意图,其显示了适合与附图1B-1D的装置一起使用的棘爪闭锁组件的一个实施例;
附图1G是部分分离的等距示意图,其显示了把柱塞运行组件或柱塞套保持在第一、待击发位置的棘爪闭锁组件;
附图1H是部分分离的等距横截面示意图,其显示了在第二、释放位置的附图1G的棘爪闭锁组件和柱塞运行组件;
附图1I是沿着附图1G的1I-1I线取的横截面示意图;
附图1J是沿着附图1H的1J-1J线取的横截面示意图;
附图2A是立面分解示意图,其显示了适合与用于把一定量药物输送到骨髓的装置一起使用的药筒组件的一个实施例;
附图2B是显示了附图2A中的药筒组件的横截面和立面示意图;
附图2C是立面分解示意图,其显示了适合与用于把一定量药物输送到骨髓的装置一起使用的药筒组件的另一个实施例;
附图2D是显示了附图2C中的药筒组件的横截面和立面示意图;
附图3A是部分分离的立面示意图,其显示了用于与骨髓流通流体的骨穿透针的一个实施例;
附图3B是部分分离的立面示意图,其显示了用于与骨髓流通流体的骨穿透针的另一个实施例;
附图3C是沿着附图3A的3C-3C线取的横截面示意图;
附图4A是部分分离的横截面和立面的分解示意图,其显示了包含了本公开教导的与柱塞运行和药筒驱动机构可释放地接合的药筒组件的一个实施例;
附图4B是部分分离的横截面和立面的示意图,其显示了根据本公开教导的附图4A中的药筒组件从柱塞运行和药筒驱动机构的释放;
附图5是显示了把一定量药物输送到骨髓的一种方法的方框图;
附图6是横截面和立面的示意图,其显示了包括有驱动器的用于把一定量药物输送到骨髓的装置的另一个实施例;
附图7A是部分分离的横截面和立面的示意图,其显示了根据本公开教导的与柱塞运行和药筒驱动机构可释放接合的药筒组件的另一个实施例;
附图7B是部分分离的横截面和立面的示意图,其显示了根据本公开教导附图7A中的药筒组件从柱塞运行和药筒驱动机构的释放;
附图8A是部分分离的横截面和立面的示意图,其显示了根据本公开教导的与柱塞运行和药筒驱动机构可释放接合的药筒组件的又一个实施例;
附图8B是部分分离的横截面和立面的示意图,其显示了根据本公开教导附图8A中的药筒组件从柱塞运行和药筒驱动机构的释放。
具体实施方式
通过参照附图1A-8B可以最好地理解本发明的优选实施例及优点,其中类似的附图标记表示相同和类似的部件。
在本专利申请中术语“流体”可被用于包括适于注入骨髓或其它目标位置的任何液体或液体、颗粒物质、溶解的药物和/或药品的任何混合物。在本专利申请中术语“流体”也被用于包括体液,例如但不限于可以从目标位置提取的血液和细胞。
在本专利申请中术语“流体贮存器”和“贮存器”可用于包括任何室、腔、安瓿、筒、容器或任何其它适合与包含本公开教导的药筒组件或其它装置一起使用的装置。
根据本公开的教导可用来进入骨髓和其它目标位置的装置的实施例一般在附图1A-4B和6-8B中显示。根据本公开的教导用于进入骨髓或其它目标位置的方法的一个实施例一般在附图5中所示。但是,本公开不限于例如附图1A-4B和6-8B中的例子或附图5中概括的把流体输送到骨髓的方法。
本公开的各种特征可以根据附图1A-1D中所示的装置20和附图6中所示的装置220描述。装置20可以具有几个位置,例如非待击发和空载位置(没有特别地示出),例如附图1B所示的待击发和空载位置,例如附图1C所示的待击发和装载位置和例如附图1D所示的在流体已在目标位置从药筒组件注入之后的排出位置。
装置20,如附图1A-1D所示,可包括壳体22,驱动组件30以及柱塞运行和药筒驱动机构50置于壳体中。药筒组件130可以置于壳体22的部分中。参见附图1B、1C和1D。壳体22可以包括手柄24,其尺寸和轮廓设计成适合操作人员的手(没有特别示出)。手柄24可包括打开/关闭开关或扳机32。壳体22也可包括具有通常中空、管状结构的接收部分26。接收部分26的第一端部或远端27可以是打开的,其中伸缩式套筒58的部分可滑动地置于其中。接收部分26的第二端部或近端28可被密封或封闭,以保护与驱动组件30以及柱塞运行和药筒驱动机构50相关联的各种构件。
驱动组件30可包括与变速箱36相连接的马达34。变速箱36可以连接到驱动轴38上,以产生柱塞运行和药筒驱动机构50的旋转运动。各种马达可以令人满意地用于产生旋转、往复或任何其它类型的适于获得期望结果的运动。在这个实施例中,马达34可以由电池组40供给动力。在选择性的实施例中,马达34可以由来自标准壁装电源插座、AC到DC转换器或太阳能发电机的电力提供动力。压缩或盘绕的弹簧、蓄气筒或任何其它适合作为用于马达运行的动力源也可以被用于运行装置20。
柱塞运行和药筒驱动机构50可包括第一弹簧51、第二弹簧52和第三弹簧53。参见附图1B、1C和1D。第一弹簧51有时可被称作“柱塞弹簧”51。第二弹簧52有时可被称作“伸缩式套筒弹簧”52。第三弹簧53有时可被称作“扭转弹簧”或“棘爪闭锁弹簧”53。与弹簧51、52和53相关的各种功能在后面将详细讨论。
柱塞运行和药筒驱动机构50也可以包括可旋转的壳体54、伸缩式套筒58、柱塞运行组件82和棘爪闭锁组件110。伸缩式套筒58有时被称作“弹簧加载的伸缩式套筒58”。柱塞运行组件82有时被称作“弹簧加载的柱塞套82”。棘爪闭锁组件110有时被称作“弹簧加载的棘爪闭锁组件110”。这三个构件中的每一个将在后面详细讨论。
驱动壳体54可以用于把来自驱动轴38的旋转力或钻进力传送到可释放地啮合在柱塞运行和药筒驱动机构50内的药筒组件。药筒组件可包括流体贮存器、柱塞组件和中空的骨穿透针。包含了本公开教导的中空的骨穿透针和中空的钻进头有时被称作“骨穿透器”。来自驱动轴38的旋转和/或钻进力可被用于在选定的目标位置把骨穿透针插入骨髓中。
包含本公开教导的药筒组件的例子在附图1B、1D、1C、2A和2B中显示。但是,多种的其它药筒组件可以符合要求地与包含了本公开教导的柱塞运行和药筒驱动机构一起使用。本公开不限于药筒组件130和130a。本公开也不限于仅使用旋转和/或钻进力在选定的目标位置插入与药筒组件相连的骨穿透针。包含了本公开教导的柱塞运行和药筒驱动机构也可以向药筒组件施加纵向或轴向力,以在选定的目标位置把连接的骨穿透针插入骨髓中。施加线性力的驱动器的例子(有时称作“冲击驱动器”或“冲击驱动器装置”)在2005年2月23日递交的、序列号为11/064,156、题目为“冲击驱动骨内针”的共同未决专利申请中显示。这样的驱动器可符合要求地与包含了本公开教导的药筒组件一起使用。
驱动壳体54可以被描述成具有部分地由纵向孔56限定的中空、基本为圆柱状的结构。柱塞运行组件82可被可滑动地置于纵向孔56内,该纵向孔在旋转壳体54的第一端部54a和第二端部54b之间延伸。柱塞运行组件82的部分可以从旋转壳体54的第一端部54a延伸。参见附图1B、C、D和H。旋转壳体54的第一端部54a也可用于把包含了本公开教导的药筒组件与柱塞和驱动机构50可释放地啮合起来。
驱动壳体54的第二端部54b可以牢固地与驱动轴38啮合。对于例如附图1B、C和D所示的实施例,联轴器42可以牢固地与驱动轴38的外部部分和接近第二端部54b的旋转壳体54的内部部分啮合起来。各种类型的机械紧固器可以符合要求地被用于把联轴器42与驱动轴38和驱动壳体54啮合起来,例如定位螺钉、销和/或掣子。第二端部54b和驱动轴38之间的啮合通常阻止了驱动壳体54相对于壳体22的接收部分26而言的纵向移动。
驱动壳体54的外部尺寸和构形可以选择,以允许驱动壳体54相对于伸缩式套筒58和与柱塞运行和药筒驱动机构50相关联的其它构件而言的旋转。驱动壳体54也可以可旋转地置于与壳体22相关联的各种构件内,例如接收部分26和内部支撑件23b。
可以触发或启动柱塞运行组件82,以向与啮合在驱动壳体54的第一端部54a的药筒组件相关联的柱塞组件施加力,以在目标位置把来自药筒组件的流体注入骨髓中。柱塞运行组件82可具有例如附图1B和1G所示的第一、收缩或待击发位置和例如附图1D和1H的第二、伸出或释放位置。柱塞运行组件82优选地包括可从驱动壳体54的第一端部54a延伸的第一端部82a。当柱塞运行组件82在其第一收缩或待击发位置时,柱塞运行组件82的第二端部82b可设置成与联轴器42相邻。参见附图1B。正如后面详细讨论的,棘爪闭锁组件110可以可释放地啮合到台肩88上,以把柱塞运行组件82保持在其第一、收缩或待击发位置。参见附图1B和1G。
柱塞运行组件82有时被描述为“柱塞套”。柱塞运行组件82可具有基本圆柱形结构,部分地由缩减的外径部分84和扩大的外径部分86限定。参见附图1G和1H。可在缩减的外径部分84和扩大的内径部分86之间的柱塞运行组件82的外部形成台肩88。缩减的外径部分84可包括基本中空、圆柱形的室或腔94。
从相关联的药筒组件延伸的柱塞杆或柱塞轴可以置于腔94内。例如,附图1C和1D显示了可释放地啮合到驱动壳体54的第一端部54a上的药筒组件130和从药筒组件130延伸进入腔94的柱塞轴142的部分。在装置20的装载过程中,从药筒组件130延伸的柱塞轴142的部分或从药筒组件130a延伸的柱塞轴142a可以插入腔94内。
扩大的外径部分86(附图1B)可包括通常中空、圆柱形的室或腔96,第一弹簧或柱塞弹簧51的部分置于其中。当通过致动棘爪闭锁组件110而把柱塞运行组件82从其第一位置释放时,第一弹簧51可提供充足的力或能量,以把柱塞轴142推到附连的药筒组件130中并把柱塞或活塞144连接到附连的药筒组件130上,以在目标位置把来自药筒组件130的流体注入骨髓中。
柱塞和驱动机构50也可包括可滑动地置于壳体22内的伸缩式套筒58。套筒58被描述为通常伸长的、中空的圆柱体,其部分地由第一端部或远端58a和第二端部或近端58b限定。套筒58可具有例如附图1A、1B和1C所示的第一、伸出位置和例如附图1D所示的第二、收缩位置。
如附图1A-1D所示,可在接近第一端部或远端58a的套筒58上形成切口(cut-out)或窗口60。窗口60可以用于确认药筒组件是否已经被装载并正确地就位在装置20内。对于一些应用,可以由透明的塑料类型的材料(没有特别示出)形成伸缩式套筒,这种材料不需要使用切口或槽口60以表明药筒组件何时已经被可释放地安装在装置20内。
如附图1B-1D和1G-1J所示,套筒58可以包括缩减的外径部分64和扩大的外径部分66,在它们之间形成台肩68。在接近台肩68的套筒58的内径上可形成有斜坡(ramp)或触发器70。参见附图1C、1I和1J。当相关的药筒组件在目标位置已经被插入期望的深度时,在驱动壳体54旋转时斜坡70可与棘爪闭锁组件110相接触以释放柱塞运行组件82。如附图1D、1I和1J所示,当驱动壳体54旋转时,套筒58从壳体22的第一端部27向壳体22的第二端部28的纵向运动或滑动将导致斜坡70接触棘爪闭锁组件110的部分。伸缩式套筒58从其第一伸出位置向第二收缩位置的运动将通常不会导致斜坡70接触或释放棘爪闭锁组件110。
对于一些应用,壳体22的接收部分26可包括第一内部支撑件23a和第二内部支撑件23b。参见附图1B、1C和1D。内部支撑件23a和23b优选地互相间隔开,并且牢固地啮合到接收部分26。对于一些应用,内部支撑件23a和23b中可形成有基本圆形的开口(没有特别示出)。第一内部支撑件23a中的开口的尺寸设计成能可滑动地接收套筒58的缩减的外径部分64。如附图1B和1C所示,当套筒58处于其第一、伸出位置时,内部支撑件23a可以啮合到台肩66或与其接触。
第二内部支撑件23b中可以形成有通常圆形的开口(没有特别示出),其尺寸被设计成可与驱动壳体54的外径相适。参见附图1B-1D。第二弹簧52可以置于第二支撑件23b和凹陷之间的壳体22的接收部分26中,该凹陷部分地由在套筒58的扩大外径部分66的内部上形成的台肩72限定。驱动壳体54的部分可以置于第二弹簧52内。参见附图1C。
当相关联药筒组件的骨穿透针在目标位置被插入骨髓中时,套筒58通常从壳体22的第一端部27向着壳体27的第二端部28收缩或滑动。参见附图1D。这种运动将压缩处于第二支撑件23b和在扩大外径部分66内部上形成的台肩72之间的第二弹簧52。当装置20从与病人皮肤接触的位置移开时,第二弹簧52将使套筒58返回到附图1B所示的其第一伸出位置,此时台肩68与第一支撑件23a相接触。
当相关联的骨穿透针在目标位置被插入到骨髓中时,伸缩式套筒58从其第一、伸出位置(附图1B和1C)向其第二、收缩位置(附图1D)的运动将导致棘爪闭锁组件110在驱动壳体54旋转过程中接触斜坡或触发器70。参见附图1I和1J。斜坡70接着将使棘爪闭锁组件110从其第一、阻塞位置(附图1B和1G)移动到其第二位置(附图1D和1J),这将导致柱塞运行组件82从例如附图1B所示的其第一、待击发位置释放。第一弹簧51接着将使柱塞运行组件82移动到例如附图1D所示的第二、释放或发射位置。棘爪闭锁组件110仅仅是适合把柱塞运行组件从待击发位置释放的机构的一个例子。
附图1E显示了骨穿透器160插入到骨334和相关联的骨髓336中。骨334通常被描述为肱头。对于一些应用,由于通过相关联骨髓的血液流率相对高以及相对容易接近,肱头是优选的目标位置。各种类型的连接可以用于通过骨穿透器160和静脉管道340与骨髓336流通流体。例如直角连接器342可以与管道340的一端啮合。直角连接器342的优势是允许管道340以不会扭结或夹住管道340内腔的角度连接到骨穿透器160上。直角连接器342也可包括Luer配件343,其尺寸被设计成能插入接套300的端部302。锁紧螺帽344可以用于把直角连接器342与接套300的第二端部302附近的螺纹连接303啮合在一起。
很多医疗装置,例如注射器、皮下针、导管、IV管和阻断旋塞(stopcocks),可包括或者销式(阳)或者套式(阴)Luer类型配件。销式端部或套式端部可包括螺纹,该螺纹允许将相关联的医疗装置可释放地啮合到具有互补的Luer类型配件的其它设备上。Luer类型的连接有时被描述成Luer滑套或Luer锁。Luer滑套需要相关联的环扭半圈,以便牢固地把销式端部和套式端部相互啮合在一起。Luer锁起作用的方式是通过当啮合在一起并扭曲半圈或更多时形成销和套之间的密封配合。Luer锁经常包括在套式端部的螺纹锁定环,其与相关联销式端部的耳状物或凸起配合,以提供更加积极的锁定连接。Luer连接通常形成不漏流体的密封。一些Luer连接可包括锥形配件。
对于一些应用,接套300的第二端部302可以被修改成具有前述的Luer连接的一个或多个特征。接套300的第二端部302和螺纹连接303可被设计成适合连接各种类型连接器,这些连接器被用于通过骨穿透器160与骨髓或其它目标位置之间流通流体。
附图1E显示了可用于在骨穿透器160和管道340之间流通流体的连接器的仅仅一个实施例。静脉管道可以用于向相关联的骨髓提供静脉流体和/或药物。管道也可用于从骨髓中提取血液样品。其它连接器或适配器也可用于把穿透器连接到静脉管道、其它类型管道和/或注射器。
如附图1B、1C、1D和1F-1J所示,棘爪闭锁组件110可以被置于介于第一端部54a和第二端部54b之间的驱动壳体54的部分内。棘爪闭锁组件110可包括枢轴112,棘爪或凸轮114可旋转地安装在其上。棘爪114可包括从枢轴112延伸的第一凸角114a和第二凸角114b。第一凸角或第一部分114a的尺寸可以设计成能可释放地啮合到在柱塞运行组件82的外部上形成的台肩88。第二凸角或第二部分114b的尺寸可以设计成啮合到斜坡或触发器70上。第三弹簧或棘爪弹簧53也可以安装到枢轴112上并啮合到棘爪114上。
棘爪114可具有例如附图1B和1G所示的第一位置,其相应于相关联的柱塞运行组件82的第一待击发位置。第三弹簧53优选地把棘爪114偏压到其第一位置,可释放地把第一凸角114a啮合到台肩88。棘爪114可具有第二位置,其相应于柱塞运行组件82的第二、释放位置。参见附图1D和1H。
对于一些应用,驱动壳体54可包括从第一端部54a延伸的开口或槽116。开口或槽116的尺寸可以设计成能适合枢轴销112插入相关联的棘爪114和第三弹簧53。附图1G和H。驱动壳体54也可包括开口或槽118,其尺寸被设计成接纳枢轴112的相反端部。附图1B和1D。在驱动壳体54的外部可形成窗口或槽口,以允许穿过其插入包括凸角114b的棘爪114的部分。
当柱塞运行组件82处于其第一待击发位置时,棘爪114的第二凸角或第二部分114b将与斜坡或触发器70纵向间隔开。在相关联的药筒组件旋转和骨穿透器在目标位置插入过程中,伸缩式套筒58将相对于驱动壳体54的外部而言纵向滑动。伸缩式套筒58的纵向运动与驱动壳体54的旋转一起将导致斜坡或触发器70啮合第二凸角114b,从而在枢轴销112上旋转棘爪114。这样的旋转导致第一凸角114a释放,或允许柱塞运行组件82从其第一待击发位置向其第二释放位置移动。正如前面讨论的,这种运动将导致来自药筒组件130的流体通过穿透器160在目标位置注入骨髓。
根据本公开的教导形成的药筒组件可包括流体贮存器,其具有通常中空的圆柱形结构,其部分地由第一远端和第二近端限定。具有中空骨穿透针的接套可以连接到第一远端。柱塞组件的部分可以可滑动地置于流体贮存器内,以促使容纳在流体贮存器内的流体通过附连的中空骨穿透针。柱塞组件可包括柱塞轴和柱塞活塞。柱塞轴的部分可从流体贮存器的第二近端延伸。
对于一些应用,包含本公开教导的药筒组件可利用与预充注射器相关联的技术来预充特定的流体。对于另一些应用,包含本公开教导的药筒组件可通常是空的,直到在每个药筒组件使用之前才充满流体或药物。包含本公开教导的药筒组件经常在一次使用后处理掉。但是,对于一些应用,包含本公开教导的药筒组件可以使用多次并可以在一个或多个目标位置使用。
药筒组件和相关联的流体贮存器可具有多种与皮下注射器、胰岛素注射器或结核菌素注射器类似的构形和功能。例如,流体贮存器132和132a(附图2A和2C)可包含一定量含有药物或药品的流体,以输送到骨髓或其它选定的目标位置。药物或药品可通常以液体形式获得。但是,可以使用任何合适形式的药品,包括固体、粉末、胶囊或任何其它已知形式。药物或药品可包括例如用于心脏复活的急救药、抗生素、解毒剂和任何其它适于配送到人体内的药品。流体贮存器132和132a也可用于注入静脉流体或任何其它用于特殊目的所需的物质。
本公开的各种特征可以相对于附图2A-2D所示的药筒组件130和130a描述。包含本公开教导的药筒组件可具有与医疗注射器相关联的一些特性。但是,与药筒组件130和130a相关联的各种构件可以根据本公开的教导进行修改,以适应把相关联的中空骨穿透针插入骨髓或其它选定目标位置。
药筒组件130可包括筒或流体贮存器132,其具有部分地由内径134限定的通常中空的圆柱形结构。筒132可包括第一端部131和第二端部133。接套300和相关联的中空骨穿透针或骨穿透器160可以可释放地啮合到第一端部131。筒132可以由可回收使用的玻璃、一次性塑料、玻璃复合物、塑料复合物和其它适于容纳流体的任何材料形成,这取决于药筒组件130的指定用途。筒132有时可被描述成“安瓿”。
各种类型的柱塞组件可以适合与包含了本公开教导的药筒组件一起使用。对于一些应用,柱塞组件140可包括柱塞轴或柱塞杆142和柱塞活塞144。对于一些应用,柱塞轴142的第一端部145可以可释放地啮合到柱塞活塞144上。对于另一些应用,柱塞轴142可牢固地啮合到柱塞活塞144上。在柱塞活塞144的外径上可形成一个或多个凸起146,以形成相对于筒132的内径134而言的通常防止流体漏出的可移动的密封。柱塞活塞144也可以用作流体密封或塞子,以在把药筒组件130装载到装置20或220中之前保持流体贮存器内容纳的任何流体。各种类型的弹性体材料可以符合用于形成柱塞活塞144的要求。
响应于施加到柱塞轴142上的轴向力,柱塞组件140可从筒132的第二端部133向第一端部131滑动地移动。柱塞运行组件82从其第一收缩或待击发位置(附图1B)的释放允许第一弹簧或柱塞弹簧51向柱塞轴142施加轴向力或纵向力,并把活塞144从流体贮存器132的第二端部133附近的第一位置移动到流体贮存器132的第一端部131附近的第二位置(附图1D)。活塞144的这样移动导致来自筒132的流体通过骨穿透针160注入到骨髓或其它目标位置。
活塞144可包括凹部148,其尺寸被设计成接纳接套300的第二端部302附近形成的螺纹连接303。活塞144与螺纹连接303的啮合可允许贮存器132从接套300脱离。驱动连接器150可牢固地啮合到与接套300相反的筒132的第二端部133(附图2A和2B)。
驱动连接器150中可形成有一个或多个凹部152,其尺寸设计成可接纳从驱动壳体54的第一端部54a延伸的相应段154。参见例如附图4A和4B。每个凹部152的尺寸可选择,以形成与相关段154的可靠的适贴配合。驱动壳体154的旋转将导致每个段154接触相关的凹部152,以旋转驱动连接器150和附连的筒132。在接套300和筒132的第一端部131之间形成的连接优选地被设计成允许把这样的旋转传递到附连的骨穿透针160。
如附图2A和2B所示,多个磁铁138可以置于驱动连接器150内允许与驱动壳体54的第一端部54a形成可释放磁性啮合的位置处。凹部152、段154和磁铁138相互协作,以允许在药筒组件130和驱动壳体54的第一端部54a之间可释放的啮合。
如附图1E、2A和2B所示,接套300可被用于在插入病人皮肤、软组织和相邻的骨或其它目标位置过程中稳定附连的骨穿透器,例如但不限于骨穿透针160。接套300与骨穿透器160的组合有时被称作穿透器套件或骨内针。接套300的第一端部301可具有与选定的用于插入骨穿透器160的目标位置相适应的尺寸和构形。这样目标位置的例子包括但不限于肩头、胫骨或胸骨。接套300的第二端部302和螺纹连接303可用于可释放地啮合到筒132上。筒132的端部131具有通常圆形的开口,其尺寸被设计成其中能接纳接套300的第二端部302。可选择的O形圈306或任何其它适合的流体密封装置可以置于接套300的外部部分上,以在筒132的相邻内部部分之间形成流体屏障。参见附图2A和2B。
附图2C和2D所示的药筒组件130a可包括筒或流体贮存器132a,其具有部分地由内径部分134a、134b和134c限定的中空、通常圆柱形的结构。筒132a可包括第一端部131a和第二端部133。接套300和相关的骨穿透针160可以啮合到第一端部131a。筒132a可以由例如用于形成筒132的材料形成。
各种类型的柱塞组件可以符合与药筒组件130a一起使用的要求。对于一些应用,柱塞组件140a可包括柱塞轴或柱塞杆142a和柱塞活塞144a。对于一些应用,柱塞轴142a的第一端部145可牢固地啮合到柱塞活塞144a上。对于另一些应用,第一端部145可以可释放地啮合到活塞144a上,例如附图2D、4B、7B和8B所示。
在柱塞活塞144a的外径上可形成一个或多个凸起146,以形成相对于内径部分134a而言通常流体不泄漏的可移动的密封。活塞144a的第一端部147可被构造成与筒132a的锥形内部表面134b形成通常流体不泄漏的密封。柱塞活塞144a也可以用作流体密封或塞子,以在药筒组件130a插入装置200或220之前保持贮存器132a内容纳的流体。各种类型的弹性体材料可以符合用于形成柱塞活塞144a的要求。
响应于施加到柱塞轴142a上的轴向力,柱塞组件140a可以从筒132a的第二端部133向第一端部131a滑动地移动。柱塞运行组件82从其第一收缩位置的释放允许第一弹簧或柱塞弹簧51施加轴向力或纵向力,以把活塞144a从第二端部133附近的第一位置移动到第二位置,在第二位置与筒132a的锥形内径部分134b形成通常流体不泄漏的密封。
如附图2C和2D所示,接套300a的第二端部302也可啮合到筒132a。筒132a的端部131a可包括缩减的内径部分134c,螺纹137形成在其内。内径部分134c的尺寸可选择,以与接套300a的第二端部302的外径相适应。接套300a的第二端部302可包括形成在其外部上的螺纹303或其它任何合适的配件。螺纹303可与螺纹137啮合。第二端部302可具有通常圆柱形销类型构形,其适合与筒132a的第一端部或套式端部131a相啮合。在很多应用中,在使用相关的药筒组件130a过程中,接套300a将保持牢固地啮合到筒132a的第一端部131a。
对于一些应用,接套300a的第一端部301可具有通常的法兰结构。狭缝或凹槽304可在第一端部301中形成,其尺寸设计成能接纳护盖或针帽334的一个端部。狭缝或凹槽304可被用于可释放地把盖334与接套300a啮合在一起。
如附图2C和2D所示,在接套300a的外部部分上可形成多个脊320,以允许当把相关联的药筒组件装载到装置20或200时操作人员能握住相关的穿透器组件或穿透器套件。脊320也可有助于从目标位置移走骨穿透器160。纵向脊320也可以被握住,以使接套300a与筒132a的第一端部131a啮合和/或脱离。
接套300a的第一端部301的尺寸和构形可以变化,以适应不同的目标位置和/或病人。接套300a可以符合要求地与多种法兰或其它适于接触病人皮肤的结构一起使用。本公开不限于接套300a或骨穿透器160。
对于一些应用,药筒组件可仅包括单个中空骨穿透针。对于另一些应用,药筒组件可包括例如插管或中空骨针或中空钻头(没有特别示出)等的外部穿透器和例如管心针、套管针或其它可移除装置(没有特别示出)等置于外部穿透器内的内部穿透器。对于一些实施例,骨穿透针160和160a可包括管心针(没有特别示出)。
穿透器可以相对较小以用于小儿科病人,也可以是用于成人的中等尺寸,和用于体形超大成人的大号尺寸。用于具体应用中的穿透器的长度和直径可取决于装置所应用到的骨的尺寸。取决于指定的用于插入相关联穿透器组件的临床用途,可提供多种结构的穿透器。例如,有一种结构用于向病人骨髓配送药品或流体,有另一种可供选择的结构用于从病人提取骨和/或血液样品。其它结构可适于骨和/或组织的活检。一些穿透器可适于不止一种用途。骨穿透器的结构和尺寸也可取决于每个穿透器插入所选择的目标位置来改变。本公开不限于骨穿透器160或160a。
多种中空骨穿透针和中空钻能符合要求地用于根据本公开的教导向骨髓或其它目标位置输送一定量药物。附图3A和3B分别所示的中空骨穿透针160和160a仅仅是代表能够符合要求地与本公开的装置一起使用的骨穿透器的两个例子。骨穿透器160和160a是单个中空穿透器的例子。骨穿透器160和160a的尺寸可取决于选定目标位置和/或相关联药筒组件的期望应用而改变。
骨穿透针160和160a可以由不锈钢或任何其它合适材料形成。适于钻透骨进入相关联骨髓的各封闭尖部162可以在骨穿透器160和160a的各第一端部上形成。封闭尖部162可包括至少一个切削刃170,其能有效地钻透骨而进到相关联的骨髓,同时对于相应的外部骨质皮层造成的创伤最小。
可以选择骨穿透器160和160a的外径或外部部分168,以适合可靠的啮合到相关联的接套。与各尖部170相反的每个骨穿透器160和160a的第二端部的尺寸设计成能接收来自附连的药筒组件的流体。
骨穿透器160和160a可包括一个或多个侧口164,用于释放药物或者与相邻的骨髓流通流体。侧口164,即在骨穿透器160和160a侧面的孔,可被构造用于阻止骨碎片和屑通到纵向孔166中。作为示例但不是限制的方式,构造侧口164的一种方式是使每个侧口164在与钻进方向相反的方向上成角度。可供选择地,骨穿透针160和160a可包括套筒(没有特别示出),其阻止骨碎片通入骨穿透器160或160a的纵向孔166中。
附图3C是显示了相对于纵向孔166的纵轴169而言偏移或成角度的侧口164的横截面示意图。一个或多个侧口164可相对于相关联的纵向孔166和纵向轴169而言成锐角形成,以使骨碎片(没有特别示出)和/或软的身体组织(没有特别示出)对每个侧口164和相关联纵向孔166的阻塞或堵塞降到最小。例如,如果钻进以顺时针方向发生,侧口164将成逆时针的角度。参见附图3C。
附图4A和4B显示了根据本公开教导的另一符合可释放地把药筒组件与柱塞运行和药筒驱动机构的部分啮合起来的机构。但是,除了例如附图2A-2D所示的磁铁138、或例如附图4A、4B所示的滚珠制动机构、或附图7A、7B、8A和8B所示的套爪闭锁机构以外的多种可释放机构可以符合要求地与根据本公开教导的用于把流体输送到骨髓的装置一起使用。
这样的滚珠制动机构和套爪闭锁机构的其中一个特征包括保持相关联的柱塞运行和药筒驱动机构与附连的药筒组件之间的积极啮合,直到相关联的柱塞组件已从第一位置移动到第二位置之后为止。这样的运动导致包含在药筒组件内的流体在药筒组件从柱塞运行和药筒驱动机构脱离之前被注入到目标位置。
例如附图4A和4B所示的柱塞运行和药筒驱动机构50a可包括伸缩式套筒158,其运作方式与前面描述的伸缩式套筒58类似。伸缩式套筒158可包括在伸缩式套筒158的内径上形成的槽或凹部170。滚珠172与驱动连接器150协作,以保持药筒组件132a与驱动壳体54的第一端部54a之间的积极啮合,直到流体已经从药筒组件132a注出之后为止。
当相关联的驱动装置在目标位置插入骨穿透器160到期望深度时,伸缩式套筒158将移动到第二位置,以允许滚珠172径向向外移动进入凹部170。参见附图4B。滚珠172进入凹部170的运动允许驱动连接器150从驱动壳体54的第一端部54a脱离。柱塞轴142a的部分可滑出柱塞运行组件82中的腔94。参见附图4B。柱塞运行和药筒驱动机构50a在目标位置插入骨穿透器160并且柱塞轴142a使活塞144从其第一位置移动到其靠近内径部分134a的第二位置后,相关联的驱动装置可以从药筒组件132a脱离。柱塞轴142a的端部145也可从活塞144a脱离。
在一个实施例中,可以遵循附图5所列出的步骤来使用装置20把药物或流体在目标位置输送到骨髓。方法500可以从第一步骤502开始,第一步骤502包括手动压缩柱塞套82和柱塞套弹簧52。当柱塞套弹簧52被压缩后,柱塞套82可以可释放地被棘爪闭锁组件110啮合。步骤504可包括把药筒组件130或130a插入或装载到伸缩式套筒58中并且可释放地把各药筒组件130或130a与相关联的柱塞运行和药筒驱动机构啮合。在一个实施例中,药筒组件130或130a可通过例如一个或多个磁盘138之类的磁性机构啮合驱动壳体54。
一旦药筒组件130或130a与驱动壳体54啮合而且柱塞运行组件82处于其压缩位置,装置20就可被认为“装备好”并准备好“发射”相关联的骨穿透器进入例如覆盖骨髓的骨这样的目标位置。可供选择的目标位置可包括其它身体组织或体腔。用于输送药物或流体的装置20的使用可以应用到身体内任何期望的位置。
在准备了选定的目标位置之后,例如肱头或近侧胫骨,装置20可就位,此时伸缩式套筒58的第一端部58a被置于目标位置处覆盖骨和骨髓的皮肤上,以插入骨穿透针160。可启动开关或扳机32,以开始钻入骨和相邻的目标骨髓。参见附图1C和1D。骨穿透针160可首先穿透皮肤,紧接着穿透相邻软组织、外骨皮层并进入目标位置的骨髓。当第一端部58a推靠在覆盖目标骨髓的组织上时,伸缩式套筒58将接触棘爪闭锁组件110,以释放柱塞运行组件82。当第一弹簧51解压时,柱塞运行组件82使柱塞轴142移入贮存器132。当迫使柱塞轴142进入贮存器132时,流体或其它任何在贮存器132内的物质被迫使进入目标骨髓或骨的骨内空间。
在药物或流体输送后,装置20可从药筒组件130脱离。接着,贮存器132可从接套300分离。接着,可通过与接套300的第二端部302连接的连接器进入骨髓。参见附图1E。这些步骤描述了用于把例如药品或药物等流体配送到目标位置的装置的仅仅一个实施例。其它机构可以包括或可以不包括一个或多个这些步骤。
附图6所示的装置220代表了用于向骨髓或任何其它目标位置提供通路的另一个实施例。装置220可具有几个位置,包括柱塞运行和药筒驱动机构250处于非待击发和空载位置(没有特别示出),待击发和空载位置(没有特别示出),例如附图6所示的待击发和装载位置,以及流体已从药筒组件130a在目标位置注入后的排出位置(没有特别示出)。
装置220,如附图6所示,可包括驱动器221,其具有壳体222和置于壳体222中的驱动组件(没有特别示出)。驱动组件可包括马达、变速箱或齿轮头以及从壳体222延伸的驱动轴238。驱动器221有时被称作“动力”的驱动器。柱塞运行和药筒驱动机构250可以是或可以不是可释放地接合到驱动器221上。柱塞运行和药筒驱动机构250典型地处于非待击发和空载位置,同时与驱动器221的驱动轴238接合。
壳体222可包括把手224,其尺寸和轮廓可被构造成适合操作人员的手(没有特别示出)。把手224可包括打开/关闭开关或扳机232。驱动轴238可从壳体222的第一端部227延伸。壳体222的第二端部228可以被密封或关闭,以保护各种构件,例如可以置于壳体222内的马达、变速箱或齿轮头和动力源。
符合与包含本公开教导的柱塞运行和药筒组件一起使用的动力驱动器的例子在题为“组织穿透装置和使用方法”的美国专利6,183,442和题为“骨内针钻入”的美国专利5,554,154中显示。也可符合与包含本公开教导的柱塞组件一起使用的动力驱动器在2003年5月30日提交的序列号为10/449,530题为“向骨髓提供紧急通路的装置和方法”的未决美国申请和2003年5月30日提交的序列号为10/449,476题为“进入骨髓的装置和方法”的未决美国申请中显示。手动驱动器(没有特别示出)也可符合与包含本公开教导的药筒驱动机构和/或柱塞运行组件一起使用,以进入病人体内的骨髓或其它目标位置。
柱塞运行和药筒驱动机构250可包括第一弹簧251和第二弹簧252。第一弹簧251有时被称作“柱塞弹簧”251。第二弹簧252有时被称作“伸缩式套筒弹簧”252。一个或多个另外的弹簧也可置于柱塞运行和药筒驱动机构250中,这取决于用于把药筒组件可释放地保持在柱塞运行和药筒驱动机构250内和/或允许柱塞运行组件280从第一待击发位置移动到第二非待击发位置的机构。
柱塞运行组件280可以置于靠近第二端部254b的柱塞运行和驱动机构250的纵向孔256内。柱塞运行组件280可包括柱塞套282。柱塞套282可包括室或腔292,其尺寸被构造成可在其中接纳柱塞组件的部分。柱塞运行组件280可以从非待击发位置(没有特别示出)移动到例如附图6所示的待击发位置。包含本公开教导的药筒组件和骨穿透针可以插入伸缩式套筒258并可释放地啮合到相关联驱动连接器上。可以使用驱动连接器150、150a、150b或其它任何包含本公开教导的驱动连接器。
伸缩式套筒258的第一端部或远端258a接着可被置于与选定的目标位置相邻。开关232可被压下,以致动驱动器221,以旋转驱动轴238并在目标位置把骨穿透针160插入到期望深度。随着骨穿透针160插入到目标位置,伸缩式套筒258将从第一、伸出位置纵向移动到第二、收缩位置,这导致柱塞运行组件280从其第一待击发位置释放,并允许第一弹簧或柱塞弹簧251迫使柱塞组件140a从其第一位置移动到其第二位置,这导致把容纳在贮存器132a内的流体注入到在选定目标位置的骨髓。在柱塞组件140a完成流体注入后,例如附图4A、4B、7A、7B、8A和8B所示的各种释放机构可以符合要求地用于把药筒组件130a从柱塞运行和药筒驱动机构250释放。
柱塞运行和药筒驱动机构250也可包括部分地由第一端部254a和第二端部254b限定的驱动壳体254。驱动壳体254可具有基本中空圆柱形结构,其部分地由从第一端部254a向着第二端部254b延伸的纵向孔256限定。伸缩式套筒258可以可滑动地设置在纵向孔256内并从第一端254a延伸。伸缩式套筒258也可包括第一端部或远端258a和第二端部或近端258b。伸缩式套筒258的外径和纵向孔256的内径优选地被选择成允许伸缩式套筒258从附图6所示的第一、伸出位置纵向滑动到第二收缩位置(没有特别示出)。
驱动壳体254的第二端部254b除了开口262外基本是封闭的,开口262优选地尺寸构造成可以接纳驱动轴238。驱动轴238的旋转可以通过与开口256相邻的驱动壳体250的部分被传递。驱动壳体254可用于把来自驱动轴238的旋转力或钻进力传递到可释放啮合到柱塞运行和药筒驱动机构250上的药筒组件。
附图7A和7B显示了柱塞运行和药筒驱动机构50b的部分,药筒组件130a可释放连接到其上。释放机构180通常被描述为套爪闭锁组件,该组件具有多个套爪夹指182,各套爪头184位于每个套爪夹指182的端部。套爪闭锁组件180可符合要求地用于可释放地啮合在驱动壳体54b的第一端部54a附近的药筒组件130a的驱动连接器150a。
柱塞套82a可包括在其外部形成的凹部或槽188。当相关联的柱塞套82a从待击发位置转换到释放位置,槽188将与套爪夹指182的第二端部186对准。优选地,槽188的尺寸选择成允许每个套爪夹指182的第二端部186被接纳在其中。相关联的伸缩式套筒(没有特别示出)可包括扩大的内径部分,其适应套爪夹指182和相关联套爪头184的径向膨胀,以释放它们与驱动连接器150a的啮合。因此,相关联的驱动装置可以从药筒组件130a上移走。
附图8A和8B显示了柱塞运行和药筒驱动机构50c的部分,药筒组件130a可释放地连接到其上。释放机构180a通常被描述为套爪闭锁组件,该组件具有多个套爪夹指182a,各套爪头184a位于每个套爪夹指182a的端部。套爪闭锁组件180a可符合要求地用于可释放地啮合在驱动壳体54c的第一端部54a附近的药筒组件130a的驱动连接器150a上。
柱塞轴或柱塞杆142b可包括在其外部形成的凹部或槽176。当相关联的柱塞套(没有特别示出)从待击发位置移动到释放位置,凹部或槽176将与滚珠172a以及每个套爪夹指182a的第二端部186a对准。优选地,凹部176的尺寸选择成允许滚珠172a被接纳在其中。相关联的伸缩式套筒(没有特别示出)可包括扩大的内径部分,其适应套爪夹指182a和相关联套爪头184a的径向膨胀,以释放它们与驱动连接器150a的啮合。因此,相关联的驱动装置可以从药筒组件130a移走。
装置20或220可以用于进入身体内任何骨的骨髓,包括但不限于胫骨、肱头或胸骨。装置20或220可被用于进入股骨、桡骨、尺骨、髂骨脊突和内踝或任何其它包括非骨目标的身体的目标位置。装置20或200可被用于进入成人、儿童和任何动物种类的骨和骨髓。装置20或200也可以用于进入其它组织或体腔。
装置20和220可以用于以任何适于配送的形式向骨髓或其它目标位置配送单位剂量的药物。这样的药物包括但不限于在治疗心搏停止过程中的用于复活的药物、抗生素、毒药解毒剂、神经毒气解毒剂和用于保护身体免受辐射的辐射防护剂。装置20或220可用于配送任何合适的流体或其它适于注入身体内骨髓或其它位置的物质。这样的流体包括但不限于生理盐水、乳酸Ringer溶液、血液、血浆、白蛋白或其它生物兼容流体。
根据本公开教导构成的装置20和220可以具有人体工程学的设计,其允许插入压力或作用力,例如旋转、钻进、冲击、纵向和/或手动力,被相对容易地施加,同时允许插入从相关联药筒组件延伸的骨穿透器。当动力驱动器旋转可释放地啮合的药筒组件时,其中骨穿透器从药筒组件延伸,把手22和222可以与操作人员的手和手腕的解剖学的中立位置对齐。这种对齐可以允许当相关联的骨穿透器被插入骨髓或其它目标位置时装置20和220更好地轴向定向,同时骨穿透器过度运动和/或失准的概率变小了,而这种过度运动和/或失准将导致相关插入孔不期望的变宽和/或伸长。
尽管本公开及其优点已经详细描述,应当理解可以进行各种变化、替代和改变而不脱离由所附的权利要求所限定的公开的实质和范围。
Claims (2)
1.一种用于向骨的骨髓输送一定量流体的装置,包括:
柱塞运行和药筒驱动机构;和
具有流体贮存器和骨穿透针的药筒组件。
2.如权利要求1所述的装置,其中,所述柱塞运行和药筒驱动机构还包括柱塞套、置于柱塞套内的弹簧、和用于释放弹簧以提供充足的力以把流体从流体贮存器注入骨髓中的闭锁机构。
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US8684978B2 (en) | 2014-04-01 |
CA3023005C (en) | 2021-04-20 |
CN101198367B (zh) | 2010-12-01 |
US8038664B2 (en) | 2011-10-18 |
EP1919538B1 (en) | 2017-06-14 |
WO2007018809A2 (en) | 2007-02-15 |
EP3228344B1 (en) | 2020-02-26 |
US20120109061A1 (en) | 2012-05-03 |
US20100160868A1 (en) | 2010-06-24 |
US7811260B2 (en) | 2010-10-12 |
EP1919538A2 (en) | 2008-05-14 |
CA2612483C (en) | 2018-12-18 |
CN101791448A (zh) | 2010-08-04 |
US20090112168A1 (en) | 2009-04-30 |
US20090326486A1 (en) | 2009-12-31 |
CA3023005A1 (en) | 2007-02-15 |
US11065382B2 (en) | 2021-07-20 |
US20050261693A1 (en) | 2005-11-24 |
EP3228344A1 (en) | 2017-10-11 |
WO2007018809A3 (en) | 2007-04-05 |
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