CN101474088B - 手动式骨内器械 - Google Patents

手动式骨内器械 Download PDF

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CN101474088B
CN101474088B CN2009100066313A CN200910006631A CN101474088B CN 101474088 B CN101474088 B CN 101474088B CN 2009100066313 A CN2009100066313 A CN 2009100066313A CN 200910006631 A CN200910006631 A CN 200910006631A CN 101474088 B CN101474088 B CN 101474088B
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penetration device
joint
needle stand
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CN101474088A (zh
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拉里·J·米勒
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Taliford Life Science Co.,Ltd.
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3472—Trocars; Puncturing needles for bones, e.g. intraosseus injections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/025—Pointed or sharp biopsy instruments for taking bone, bone marrow or cartilage samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3476—Powered trocars, e.g. electrosurgical cutting, lasers, powered knives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A61B17/3496—Protecting sleeves or inner probes; Retractable tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/025—Pointed or sharp biopsy instruments for taking bone, bone marrow or cartilage samples
    • A61B2010/0258—Marrow samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477—Coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3492—Means for supporting the trocar against the body or retaining the trocar inside the body against the outside of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • 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
    • A61B17/92—Impactors or extractors, e.g. for removing intramedullary devices
    • A61B2017/922—Devices for impaction, impact element
    • A61B2017/924—Impact element driving means
    • A61B2017/925—Impact element driving means a spring

Abstract

一种穿透骨头骨髓的器械。该器械包括具有驱动轴的手柄、具有第一和第二端的接头以及具有进入到骨髓内的穿透器的穿透器针座，其中所述第一端可操作而连接到驱动轴上，而第二端可操作而连接到穿透器针座上。

Description

手动式骨内器械
本发明是2005年1月25日提出的名为“手动式骨内器械”的发明专利申请No.200580003261.8的分案申请。
相关申请
本申请要求于2004年1月26日递交的、名称为“手动式骨内器械”的No.60/539171临时专利申请的优先权。
本申请要求于2004年2月26日递交的、名称为“冲击驱动式骨内针”的No.60/547868临时专利申请的优先权。
技术领域
本发明总体上涉及一种用于进入骨髓的医疗器械，更具体地是涉及一种用于穿透骨头并且将穿透器或者针插入到相关的骨髓内的器械和方法。
发明背景
每年，在美国有数百万的患者因为威胁生命的紧急情况而接受治疗。这种紧急情况包括休克、外伤、心脏病、药物过量、糖尿病酮酸中毒、心律失常、烧伤以及癫痫，这里仅仅列举了一些。例如，根据美国心脏协会的统计，每年超过1,500,000的患者受到心脏病的威胁(心肌梗塞)，他们中超过500,000人死于致命的并发症。
处理所有这些紧急情况的关键因素就在于快速确立静脉(IV)注射管，以将药物和流体直接注入到血液循环系统内。无论是在急救车内由护理人员救治，还是在急救室内由应急专家救治，其目标都是相同的——启动静脉注射以将挽救生命的药物和流体注入。在实施进入血管的过程中，成功地处理这些危重紧急情况的能力极大程度地取决操作者的技能和运气。尽管对某些患者启动静脉注射相对容易，但在对大约20％的患者建立静脉进入时，医生、护士和护理人员经常经历极大的困难。在尝试解决此问题时，反复地采用锋利的针刺这些患者，并且可能会需要侵入性的过程以最终建立静脉进入。
在实现进入静脉时另一复杂因素发生在“现场”中，例如，在事故现场或者在救护车的运输途中，这时难于找到目标，并且过分的运动使得进入静脉系统非常困难。
在患者患有慢性疾病或者年纪较大的情况下，根本找不到容易进入的静脉。由于周围静脉的解剖性缺乏、肥胖、极度脱水或者之前采用过IV药物，其他患者可能没有可用的IV位置。对于这些患者，找到用于注入挽救生命的药物的适当位置变成了意义重大而又令人沮丧的任务。在发病率和死亡率统计通常不能得到时，已知的是，由于挽救生命的IV疗法进入血管系统被延迟或者只是不可能，而使许多遭遇威胁生命的紧急情况的患者死于并发症。对于这些患者，需要找到可替代的方法。
例如为注射器、皮下注射器针头、导管、IV管和旋塞的许多医疗装置可包括销式(外螺纹)或者套筒式(内螺纹)路厄式适配件。销的端部或者套筒的端部可包括螺纹，这些螺纹允许相关的医疗器械可拆卸地与其它设备接合，其中所述其它设备具有互补的路厄式适配件。路厄式接头在某些时候被称作路厄式滑套(slip)或者路厄式锁。路厄式滑套需要相关的卡箍拧半圈，从而使销的端部和套筒的端部彼此牢固接合。当被接合并且被拧半圈或者更多圈时，路厄式锁通过在销和套筒之间形成水密式配合而发挥作用。路厄式锁通常包括位于套筒端部上的螺纹锁定卡箍，其中所述卡箍与相关的销端部的耳部或者突出部匹配，从而提供了更为主动的锁定连接。路厄式接头通常形成流体紧密封。一些路厄式接头可包括锥形适配件。
发明内容
根据本发明的教导，提供了一种与骨头的骨髓相通或者进入到其内的器械和方法。该器械可包括具有驱动轴的手柄、具有第一和第二端的接头，其中所述第一端可操作而连接到驱动轴上，而第二端可操作而连接到穿透器针座(hub)上。穿透器针座可包括可操作而进入到骨髓内的穿透器。
在替换实施例中，提供了一种手动式穿透骨头和相关骨髓的器械。该器械可包括具有至少一根驱动轴的手柄、具有第一端和第二端的可拆卸的接头，其中所述第一端可操作而连接到所述至少一根驱动轴上，而第二端可操作而连接到穿透器针座上。穿透器针座具有可操作而连接到接头上的适配件和可操作地而入到骨髓内的穿透器。
在另一实施例中，提供了一种进入骨头骨髓内的方法。该方法可包括利用具有手柄、驱动轴和带有可操作而连接到驱动轴上的第一端和可操作而连接到穿透器组件上的第二端的接头的器械将穿透器插入到骨髓内。对于一些应用场合而言，可将套管针设置在穿透器组件内。在将穿透器组件的部分插入到骨髓内后，可使手柄和接头与穿透器组件脱离开。套管针在使用时可从穿透器组件和相关的穿透器上拆卸下来。
在器械的各个实施例中，手柄可为T形、手枪型、圆形或椭圆形、人体工程学设计的把手或者任何其它适用于通用或特殊用途的形状。在各个实施例中，手柄可包括将骨内针包围的腔室、穿透器和相关的套管针或者任何其它适于与该器械一起使用的附件。
在另一实施例中，提供了一种将骨头的骨髓穿透的动力驱动器械。该器械可包括壳体、马达、齿轮传动组件、至少一根驱动轴和动力源，和至少一根可操作而与辅助装置相连并且还可操作而将旋转能量提供给辅助装置的驱动轴。在各个实施例中，辅助装置可包括环状切割器、吸入装置或闪光灯。
包括本发明教导的器械和方法可用于任何目的进入到人类或者动物的任何骨头的骨髓内，其中所述目的包括输送流体、药物、药剂、化学制品以及任何其它包括血液在内的生物活性物质。本发明的教导还可用于抽取骨髓和/或干细胞。本发明的教导还可用于进入人类或动物的除了骨髓外的身体组织或体腔。
附图的简要说明
结合附图并参照以下说明可对本发明的实施例和其优点进行更为完整和彻底的理解，其中在所述附图中，相同的附图标记表示相同的部件，并且其中：
图1A为可操作用于穿透骨头骨髓的器械的示例图；
图1B为图1A中器械的分解示意图；
图1C为图1A中器械的端部示意图；
图1D为包含本发明教导的驱动器和接头的一个例子的示意图；
图1E为根据本发明的教导的穿透器组件的示例的示意图，其中所述穿透器组件可拆卸地与手柄相接合；
图1F为根据本发明的教导的各部分被剖开的穿透器组件的分解剖面示意图，其中所述穿透器组件具有外穿透器和内穿透器并可拆卸地与手柄接合；
图1G为形成于根据本发明教导的内穿透器上的尖端的放大示意图；
图1H为形成于根据本发明教导的外穿透器上的尖端的放大示意图；
图1I为根据本发明的教导的器械的一个示例的各部分剖开的剖面正视示意图，其中所述器械与骨的骨髓相连通；
图2为根据本发明的教导的用于穿透骨的骨髓的器械的示例图；
图3A为根据本发明的教导的可操作用于穿透骨的骨髓的器械的示例图；
图3B为根据本发明的教导的可操作用于穿透骨的骨髓的器械的示例图；
图3C为根据本发明的教导的可操作用于穿透骨的骨髓的器械的示例图；
图3D为根据本发明的教导的可操作而封闭穿透器组件的容器的立体示意图；
图4A为根据本发明的教导的用于穿透骨的骨髓的器械的另一示例图；
图4B为根据本发明的教导的各部分被剖开的穿透器组件的一个例子的剖面示意图，其中所述穿透器组件可拆卸地与驱动轴接合；
图4C为剖面示意图，它示出了根据本发明的教导的形成于各部分被剖开的穿透器组件内的开口的另一示例，其中所述穿透器组件可拆卸地与驱动轴接合；
图4D为剖面示意图，它示出了根据本发明的教导的形成于各部分被剖开的穿透器组件内的开口的再一示例，其中所述穿透器组件可拆卸地与驱动轴接合；
图5A为根据本发明的教导的改进的辅助装置的示例图，其中所述辅助装置与可操作用于穿透骨的骨髓的装置一同使用；
图5B为可操作用于穿透骨的骨髓并且适于操作辅助装置的动力驱动器械的示例图；
图6A为根据本发明的教导的可操作用于穿透骨的骨髓的器械的另一示例的分解示意图；
图6B为根据本发明的教导的可操作用于穿透骨的骨髓的器械的又一示例的示意图；
图7为根据本发明的教导的适用于使管与针座和穿透器连接的适配件的一个例子的分解示意图。
发明的详细说明
通过参照附图1A-7，可最好地理解本发明的一些优选实施例和它的优点，其中在所述附图中相同的附图标记表示相同和类似的部件。
就治疗人类患者来描述本发明的各个方面。然而，包含本发明教导的器械和方法还可用于治疗动物。
有时候，电池动力的驱动器不能有效地用于或不适用于骨内(IO)进入。这些情况可能涉及军事的特殊行动，因为极端的温度和严格的重量限制限制了在战斗中的可携带物。对于民用紧急医疗服务(EMS)或者第一响应者而言也是一样，因为长时间的存储并且又很少使用使得电池动力的驱动器的方便性不切实际。为此，手动驱动器提供了优于电池动力驱动器的一些优点。有时采用手动驱动器实施骨内进入比采用动力驱动器所需的时间长。但是，采用任一种驱动器都可以将骨头穿透并且进入到相关的骨髓。当使用手动驱动器时，可将人力施加到手柄或者把手上，从而将穿透器或者针插入到骨头内以进入到骨髓。在电池动力驱动器不能执行其功能时，例如由于电源枯竭的情况下，手动驱动器还可用作有用的备用件。
图1A、1B和1C示出了手动驱动器10a的一个实施例，其中手柄12a包括驱动轴16a。手动驱动器10a还可包括如图3A所示的可选择的棘轮机构。手柄12a可被成形为多种形状，例如可形成为具有手指握部20。手柄12a可采用适用于多次使用的材料或者适用于一次性或者可抛弃性使用的材料制成。还可以采用T形手柄12e(参见图3c)、大致为圆形或者卵形手柄12a(参见图1A和1B)、手枪握把式手柄12b(参见图2)或者其它任何在手动插入穿透器时适于人手或手指握持的符合人体工程学设计的形状。
根据本发明的教导，多种技术都可适用于可拆卸地将手柄接合或者连接到相关的接头和/或穿透器上。对于一些应用场合而言，手柄和相关的接头可形成为一个单独的单元。参见图6A和6B。在这种构造中，手柄/接头的组合件可操作地连接到组织穿透器的针座上。手柄和接头可以或者不可以彼此拆开。对于其它一些应用场合而言，手柄可以在不使用接头的情况下可拆卸地与针座和相关的穿透器接合。
图1B示出了部件之间分离的器械10a。手柄12a包括可选择的手指握部或者手指座20。驱动轴或者连接件16a可拆卸地与接头180的端部181接合。内穿透器或者套管针220从接头180的端部182处延伸。接头180和相连的内穿透器220彼此通过路厄式适配件、螺纹式连接或者形成于针座200的第一端201上的其它适当的适配件可拆卸地连接。外穿透器210从针座200的第二端202延伸。
图1C示出了器械10a的端部视图。
图1D中的开口186可形成在第一端181内以接收相关的驱动轴16a。参见图1D。开口186可形成为各种构造和/或尺寸。对于一些应用场合而言，开口186可包括其尺寸适于容纳驱动轴16a部分的通道或通路。一块或多块腹板136可形成在端部181内并从开口186处延伸。开放部分或者空间138可形成在腹板136之间。各个从手柄12a的相邻部分延伸的凸起146可拆卸地与腹板136和空间138接合。开口186和相关的腹板136可用于将接头180与手动驱动器或者动力驱动器可拆卸地连接。图5B示出了动力驱动器的一个例子。
图1E示出了穿透器组件160的放大视图。
如图1F所示，穿透器组件160可包括接头180、针座和相关的针座200、外穿透器210和内穿透器220。穿透器组件160可包括外穿透器(例如套管、中空管或者中空钻头)以及内穿透器(例如管心针或者套管针)。各种管心针和/或套管针都可以设置在外穿透器内。对于一些应用场合而言，外穿透器或者套管210可被描述为基本上细长的管，其尺寸适于把内穿透器或者管心针220接纳于其中。内穿透器220的部分可设置在延伸穿过外穿透器210的纵向通道184内。内穿透器220的外径和纵向通道184的内径可被选择，以便内穿透器220可在外穿透器210内可滑动地布置。
金属盘70可被设置于开口186内，用于可拆卸地将接头180和磁性驱动轴连接。对于一些应用场合而言，驱动轴16a可被磁化。内穿透器220的端部223优选地与金属盘70相间隔，其间设置有绝缘或者非导电性材料。
外穿透器210的尖端211和/或内穿透器220的尖端222可被操作以穿透骨头和相关的骨髓。尖端211和/或222的构造可被选择为以产生的外伤最小的方式穿透骨头或者其它体腔。内穿透器220的第一端或者尖端222可呈梯形，并可包括一个或多个切割表面。在一个实施例中，外穿透器210和内穿透器220可在相关的制造过程中作为一个单元被一起磨削。提供匹配的配合允许各尖端211和222作为一个单独的钻孔单元，当将穿透器组件160的部分插入到骨头和相关的骨髓内时，该单独的钻孔单元有助于插入并且使伤害最小。内穿透器220还可包括纵向凹槽(未明确示出)，该纵向凹槽沿着内穿透器220的侧部延伸，从而当穿透器组件160更深地钻入到相关的骨头内时，允许骨头屑和/或组织从插入处排出。外穿透器210可采用不锈钢、钛或者其它具有适当强度和耐用性的材料制成，以穿透骨头。
针座200可用于在相关的穿透器在所选择的插入位置处插入到患者的皮肤、软组织和相邻骨头时稳定穿透器组件160。针座200的第一端201可操作，以用于与相关的接头180可拆卸地接合或连接。针座200的第二端202的尺寸和构造可与外穿透器210相关的插入位置相适。针座200与外穿透器210的组合有时可被称作为“穿透器装置”或者骨内针。
对于一些应用场合而言，接头180可被描述成基本上为圆筒形的管，它部分地由第一端181和第二端182所限定。接头180的外部可包括与端部181相邻的扩大锥形部。若干纵向凸脊190可形成在接头180的外部上，以在与驱动轴相连时允许操作者抓紧相关的穿透器组件160。参见图1E。当外穿透器210已经插入到骨头和相关的骨髓内时，纵向凸脊190还允许接头180被抓紧，以使其与针座200分开。
接头180的第二端182可包括开口185，此开口185的尺寸适于将针座200的第一端201接收于其内。螺纹188可形成于与接头180的第二端182相邻的开口185内。螺纹适配件188可用于使接头180与和针座200的第一端201相邻的螺纹适配件208可拆卸地连接。
针座200的第一端201可包括形成于其外部上的螺纹连接件208或者其它适合的适配件。第一端201可具有大致为圆柱形销式构造，该构造适于与接头180的第二端或者套筒端182可拆卸地接合。
对于一些应用场合而言，针座200的端部202可具有法兰状的大致构造。尺寸适于容纳保护盖或者针帽234一端的角状狭槽或凹槽204可形成于端部202内。狭槽或凹槽204可用于使盖234与穿透器组件160可拆卸地接合。参见图1A、1E和2。对于一些应用场合而言，盖234可被描述为具有圆形端部232的大致为中空的管。盖234可被设置于相关的狭槽204内，以在与相关手柄相连之前保护外穿透器210的部分和内穿透器220的部分。盖234可包括形成于其外部上的若干纵向凸脊236。纵向凸脊236彼此配合，以允许在不污染相关的穿透器部分的情况下将盖或针帽234安装和拆卸。盖234可由各种塑料和/或金属制成。
针座200的第二端202的尺寸和构造可被改变，以适应各种插入部位和/或患者。针座200可令人满意地与多种法兰或者其它适于接触患者皮肤的构造一同使用。同样，端部202和相关的法兰可与各种针座一同使用。本发明不限于针座200、端部202或者相关的法兰。
通道206可从第一端201延伸通过第二端202。通道206的内径可被选择为牢牢地与穿透器210的外径接合。通道206的尺寸和构造可被选择为保持相关的穿透器组件与针座200相接合。
图1G示出了形成在被设置于外穿透器210内的内穿透器220端部上的尖端222的放大视图。图1H示出了形成于外穿透器210端部上的尖端211的放大视图。
在本发明的一个实施例中，穿透到骨髓中的步骤可包括：转动或者旋转驱动轴，以通过旋转运动将穿透器24(参见图4A)、穿透器110(参见图4B)或者穿透器210(参见图1A-1B)插入到骨头和相关的骨髓内，将相关的驱动轴从接头80或180上脱离开并且将接头80或180从相关的针座100或200上脱离开，让针座100或200以及相连的穿透器24、穿透器110或穿透器210位于骨髓内。穿透到骨和相关骨髓内的深度可由针座100的第二端102和尖端30或者尖端111的极限端之间的距离或者针座200的第二端202和尖端211的极限端之间的距离来决定。对于一些应用场合而言，螺纹连接或者适配件108或208允许与各种类型的路厄式锁和/或路厄式适配件相连，其中与静脉注射管或者注射器相关的所述路厄式锁和/或路厄式适配件与带有针座100的第一端101或者针座200的第一端201相连。
图1I示出了插入到骨头130和相关骨髓140内的外穿透器或者套管110。各种类型的连接方式都可用于使流体通过外穿透器210与骨髓140连通，然后可用于将静脉注射管150连接到外穿透器210上。直角接头132的优点是，允许管150以不会使管150的内腔发生扭结或者箍缩的角度连接到外穿透器110上。锁紧螺母133可用于使直角的接头132与针座200接合。
图1I仅示出了可用于使流体在外穿透器110和管150之间流通的接头的一个实施例。静脉注射管可用于将静脉注射流体和/或药物提供给相关的骨髓。该管还可用于从骨髓内抽取血样。其它接头或者转接器也可用于将穿透器连接到静脉注射管、其它类型的管和/或注射器上。参见图7。
根据本发明教导形成的器械可具有人体工程学设计，允许插入压力或者作用力(例如手动力)相对轻易地被施加，并且同时允许相关的手柄进行旋转动作。在图3C中，当操作者手和手腕内转和外转时，具有相关手柄12e的驱动轴16可与操作者手和手腕解剖学上的中立位置对准。当相关的穿透器插入到骨头和相关骨髓时，这种对准允许穿透器组件的轴向定位更好，穿透器不太可能有过分的运动和/或错位，而所述过分的运动和/或错位也许会导致相关的插入孔非理想的加宽和/或伸长。插入力不限于旋转力，而是可包括由人力所施加的往复或者直接的轴向力。
图2示出了根据本发明教导的器械的另一实施例，它可用于将穿透器插入到骨髓内。图2示出了手动驱动器10b，其中手柄12b包括驱动轴16b。手动驱动器10b还可包括例如由图3A所示的可选的棘轮机构。手柄12b可拆卸地与穿透器组件160接合，并且可用于本发明教导的任何其它的穿透器组件。
如图3A所示的器械10c还可包括第一驱动轴16a和第二驱动轴16c。驱动轴16a和16c可包括各自的棘轮机构14。驱动轴16a和16c可相对于手柄12c以不同的角度设置，从而与相关的穿透器组件的不同插入位置相适应，和/或适应不同类型的穿透器组件。驱动轴16a和16c可具有相同的圆形截面或者可具有不同的截面。
对于例如如图3A所示的本发明的实施例，器械10c可包括内设有至少一个腔40的手柄12c。腔40的构造和尺寸(如图3A的虚线所示)可被选择，以与一个或者多个穿透器组件和/或其它装置相适应。帽42可被固定在手柄12c的一端上，以将穿透器组件或其它装置保持在腔40内。
正如之后将要更详述的，在使用之前穿透器组件优选地被置于密封容器内。图3D示出了根据本发明教导的一个容器的例子。在腔室40内穿透器组件160以虚线示出，以表示根据本发明的教导除了容器43外的其它各种零件也可令人满意地设置在手柄内。腔室40可被构造成容纳一个或多个容器43和/或多个装置。
如图3B所示的器械10d可包括手柄12d，该手柄12d与前述的手柄相比具有改进的构造。驱动轴16b可具有4个侧面，这些侧面限定了大致为正方形或者矩形的截面。驱动轴16b还可具有5个侧面、6个侧面或者呈键形。手柄12d还包括内设有容器43的腔40。如前所述，图3C所示的器械10e可包括大致T形的手柄12e。
如图3D所示，容器43包括与之相连的盖44。盖44包括舌片46，该舌片被构造成用手的一根或多根手指就可被掀开。容器43的盖44可通过操作者的一只手打开。当盖44打开时，操作者可将穿透器组件与拿在操作者另一手上的手动或动力驱动器的驱动轴接合。柔性带48可用于使盖44与容器43可拆卸地相接合。本发明教导的容器允许穿透器组件保持在无菌环境中。当需要使用穿透器组件时，可在不污染穿透器组件的情况下将手动或动力驱动器接合到本发明教导的穿透器组件上。正如下面将要详述的，可令人满意地采用各种机构例如磁体、O形环和/或球形制动件，以允许驱动轴可拆卸地接合穿透器组件。
棘轮机构14(参见图3A、3B和3C)为可选择部件，它可被包括在一些实施例中，以为插入相关的穿透器提供另外的杠杆作用。例如，当以顺时针方向施以旋转动力时，棘轮通过与连在针组件针座上的接头相接合来发挥作用。棘轮机构14可反转，从而相关的手柄可在顺时针或者逆时针方向上旋转。本发明教导的器械可包括可旋转的卡箍(未明确示出)，它被构造成锁定和解锁可反转的棘轮机构，以改变旋转方向。本发明教导的驱动轴可连接到棘轮机构14上，以仅在一个方向上施加旋转力。棘轮机构14可为“静音”型，包括被构造成能够产生理想效果的三个滚珠轴承(未明确示出)，而不会伴有传统棘轮产生的噪音。驱动轴还可在不使用棘轮机构14的情况下连接到本发明教导的手柄上。
各种类型的穿透器和穿透器组件都可令人满意地与根据本发明教导的手柄一起使用。这种穿透器和穿透器组件的例子包括但并不局限于如图1A所示的穿透器组件22、如图4A所示的穿透器组件22以及如图4B所示的穿透器组件60。对于一些应用场合而言，穿透器组件22可包括图4A中所示的接头80、针座100和穿透器24。对于一些应用场合而言，穿透器组件60可包括图4B中所示的接头80、针座100、套管110和套管针120。对于一些应用场合而言，穿透器组件160可包括图1A中所示的接头180、针座200、套管210和套管针或管心针220。本发明教导的器械和方法可与各种手柄、接头、针座和穿透器一起使用。本发明不限于图1A-6B所示的手柄、接头、法兰、穿透器和/或穿透器组件。对于一些应用场合而言，手柄或驱动器可不使用接头就直接连接到穿透器针座上。
对于一些应用场合而言，穿透器组件可仅包括单个中空穿透器。而对另一些应用场合而言，穿透器组件可包括外穿透器(例如套管、中空针或者中空钻头)和内穿透器(例如管心针、套管针或者其它设置于外穿透器内的可拆卸的装置)。穿透器24是作为单个中空穿透器的一个例子。参见图4A。穿透器24可包括一个或多个侧孔(未明确地示出)。套管110和210是作为外穿透器的例子。套管针120和管心针220是内穿透器的例子。参见图1B和1E。
穿透器的尺寸可根据相关的穿透器组件的应用场合发生变化。对于儿科患者而言，穿透器相对较小，对于成人采用中等尺寸的穿透器，对于身材庞大的患者采用大尺寸的穿透器。例如，穿透器的长度可在5mm到30mm的范围内。穿透器的直径可在18标准尺寸(gauge)到10标准尺寸(gauge)的范围内。用在特殊应用场合中的穿透器的长度和直径可依据器械所要作用的骨头的尺寸而定。穿透器根据相关穿透器插入的临床需要可具有各种构造。例如，可有这样一种构造，用于将药物和/或流体施加到患者的骨髓中，另一种可选的构造为，对患者的骨髓和/或血液进行采样。其它构造也适用于骨头和/或活组织检查。一些穿透器可适用于不止一种用途。穿透器的构造和尺寸还可根据所选择的每一穿透器的插入位置而变化。
如图4A所示，穿透器组件22可包括接头80、针座和相关的法兰100以及穿透器24。对于一些应用场合而言，穿透器24通常可被描述为中空针，它适于使流体与骨髓相通。穿透器24可被构造为穿透骨头、骨髓或者其它身体组织或腔体。各种类型的骨内针和/或中空的钻头都可用作为穿透器24。穿透器24的尖端30可适用于响应手柄22的旋转而在骨头中钻孔。开口(未明确示出)可形成在穿透器24中并接近尖端30，从而允许流体在形成于穿透器24内的流体流道(未明确示出)和相邻骨髓之间流通。
如图4A和4B所示，针座100可用于在相关的穿透器在选择的插入位置处插入穿过患者的皮肤、软组织和相邻骨头期间稳定穿透器组件。针座100的第一端101可操作，以和相关的接头80可拆卸地接合或连接。针座100的第二端102和相关法兰的尺寸和构造与穿透器24的相关插入位置相适。针座100和穿透器24的组合有时被称作“穿透器器械或组件”。各种技术可适用于使接头80和针座100以及穿透器24可拆卸地接合。根据本发明的教导，例如，包括但不局限于机械适配件和螺纹连接和/或路厄式锁紧螺母的各种类型的机械紧固件适用于将手柄与穿透器可拆卸地接合。
对于一些应用场合而言，接头80可被描述为部分地由第一端81和第二端82限定的大致为圆柱形的杆。纵向通道84可从第一端81延伸穿过一部分接头80。对于一些实施例，例如图4B中示出的，通道84优选地在盘70之前终止。对于一些应用场合而言，纵向通道84的尺寸可适于容纳管心针或套管针。参见图4B。对于另一些应用场合而言，在无纵向通道84的情况下也可满意地采用接头80。
扩大开口可形成于第一端81内，以接纳驱动轴16。螺纹适配件88可形成为与接头80的第二端82相邻，用于将接头80和针座100的第一端101可拆卸地连接。对于一些应用场合而言，若干凸脊或缺口90可形成于接头80的外部上，以允许操作者在使穿透器组件22与驱动轴16连接时抓住穿透器组件22。凸脊或缺口90还允许当穿透器24已经插入骨头和相关骨髓时抓住接头80，以使其与针座100分开。
对于一些应用场合而言，针座100的端部102可包括环形狭槽或凹槽104，其尺寸适于容纳保护盖32的一端。狭槽或凹槽104可用于将盖32与穿透器组件22和/或穿透器组件60可拆卸地接合。参见图4B。对于一些应用场合而言，盖32可被描述为具有圆端34的大致为中空的管。盖32可设于相关的狭槽104内，以在穿透器与手动或动力驱动器相连之前保护穿透器部分。盖32可由各种塑料和/或金属制成，并且可用于穿透器组件的可替换的实施例中。
针座100的第二端102的尺寸和构造可改变，以适应各种插入位置和/或患者。通道106可从第一端101延伸穿过针座100至第二端102。通道106的内径可被选择为牢固接合穿透器24的外径和/或套管110的外径。通道106的尺寸和构造可被选择为使相关的穿透器牢固地与针座100接合。几种技术和方法都可用于将穿透器固定到针座上，所述技术和方法包括但并不局限于滚花、喷丸硬化处理、法兰(未明确示出)、粘接和/或锯齿状。
针座100的第一端101可包括位于其外部上的螺纹连接108或其它适当的适配件。第一端101可具有大致为圆柱销型的构造，适于与接头80的第二端或套筒端82可拆卸地接合。螺纹连接88可拆卸地与螺纹108相接合。
接头80、80b、80c和80d可具有类似的外部构造和尺寸，它们分别如图4A、4B、4C和4D所示。然而，本发明教导的接头的尺寸和构造与接头80、80b、80c和80d相比可被大大改进。
在每一接头80内的开口86可具有各种构造和尺寸，以与相关的驱动轴可拆卸地接合。对于一些应用场合而言，驱动轴可具有4面、5面、6面或者8面。驱动轴还可具有“D形”截面。驱动轴还可为圆形或者其它任何键形的构造。驱动轴和接头内相关的开口可相对于彼此为锥形(未明确地示出)。
如图4A所示的驱动轴16可具有5面。图4B所示相应的开口86b也可包括5面，适于可拆卸地接纳驱动轴16。对于一些应用场合而言，金属盘70可设置在开口86b内与端部81相对。金属盘70适用于使如图4B所示穿透器组件60可拆卸地与由磁化材料形成的驱动轴接合。驱动轴16可包括或包含被构造成与设置在穿透器组件60内的金属盘70可拆卸地接合的磁体。金属盘70和磁化驱动轴16之间的配合允许将穿透器组件从容器例如容器43内移出。
对于其它应用而言，一个或多个磁体72和74可设置在开口86的侧面内，以使相关的驱动轴可拆卸地与接头80b相接合。磁体72和74在图1B中以虚线示出。磁体72和/或74可用于使接头与由适当金属合金或其它材料制成的驱动轴可拆卸地接合。
对于本发明的实施例而言，例如在图4C中示出的，开口86c可具有大致呈圆形的截面。O形环96可设置在接头80c的开口86c内。O形环96可与相关驱动轴形成令人满意的接合，其中所述驱动轴具有相应的大致为圆形的截面。图3A中所示的驱动轴16a和16c可具有大致为圆形的截面。
如图4D所示的接头80d可包括球96和弹簧98，其中所示球96和弹簧98可与驱动轴内相应的止动部或凹槽(未清楚的示出)相接合。球止动机构96和弹簧98可彼此相配合，以使接头80d和相关的穿透器组件与驱动轴可拆卸地接合。根据本发明的教导其它机构也可适用于使驱动轴与接头可拆卸地接合。这些机构包括但不局限于卡环式接头(未明确示出)、锁键式接头(未明确示出)和类似的可拆卸连接。
对于如图4B所示的实施例而言，各种类型的螺纹连接或其它适当的适配件都可以采用。接头80的端部82优选地包括扩大的开口或通道，它们的尺寸适于容纳针座100的第一端101。形成在端部82内的螺纹88可拆卸地接合形成于端部101外部上的螺纹108。
对于例如由图4B所示的本发明的实施例而言，穿透器组件60可包括外穿透器(例如套管、中空针或者中空钻头)和内穿透器(例如管心针或套管针)。各种类型的管心针或套管针都可设置在外穿透器内。对于一些应用场合而言，外穿透器或套管110可被描述为具有大致细长、中空的管，其尺寸适于将内穿透器或套管针120容纳于其内。套管针120的部分可设置在延伸穿过接头80的纵向通道84内。套管针120的外径和纵向通道84的内径可被选择，以便套管针120可与接头80牢固接合。对于一些应用场合而言，金属盘70可设置在与套管针120相邻的开口86内。
外穿透器110的尖端111和/或内穿透器120的尖端112可操作，以穿透骨头和相关的骨髓。尖端111和/或121的构造可选择，从而以最小的外伤穿透骨头或其它体腔。套管针120的第一端或尖端121可包括一个或多个切割表面。在一个实施例中，外穿透器110和内穿透器120在制造过程中分别磨削，并且之后将它们对齐以确保一精确的配合，从而当穿透器组件60的部分插入到骨头和相关的骨髓时，允许各自的尖端111和121作为一个单独的钻孔单元，以便于插入并且最大程度地减小伤害。尖端111和121由此产生的结构可以最小的伤害穿透骨头或其它体腔。
内穿透器120还可包括纵向凹槽(未明确示出)，它沿着内穿透器120的侧部延伸，以当穿透器组件60更深地钻入相关骨头时，允许将骨头屑和/或组织从插入位置排出。套管110可由不锈钢、钛或者其它具有适当强度和耐用性的材料制成以将骨头穿透。
各种辅助工具和装置经常由紧急医疗服务人员和/或第一响应者所携带。图5A所示的环状切割器50可作为这种辅助工具的代表。环状切割器50可包括拇指柄52和手指保护器54。环状切割刀片56可旋转地安装在从手柄12f延伸的臂58上。
对于一些应用场合而言，环状切割刀片56可与包含本发明教导的针座接合。例如，如图5B所示，环状切割刀片56可与针座100b牢固接合。可对针座110b的第一端101进行改进，以使其具有与关于接头80b描述的开口86b类似的开口86b。对于一些应用场合而言，手柄12、12a、12b、12c、12d和/或12e可拆卸地与针座或者针座100b接合，以使环状切割刀片56旋转。对于其它应用场合而言，动力驱动的驱动器312可与针座或针座100b连接。驱动器312可包括与驱动轴300连接的电机314。电池或者电源318可设置在动力驱动器312内。扳机320可用于启动马达314。
名称为“组织穿透器械及其使用方法”的美国专利6183442和名称为“骨内针钻”的美国专利5554154中示出了可采用针座或法兰的动力驱动器的例子。在于2003年5月30日递交的、名称为“紧急进入骨髓的器械和方法”、申请号为No.10/449503的美国待审专利申请以及于2003年5月30日递交的名称为“进入骨髓的器械和方法”、申请号为10/449476的美国待审专利申请也示出了动力驱动器。
在其它需要旋转力或动力的场合，拥有可靠的动力驱动器对于操作者而言是有利的。例如，驱动轴300可与以旋转或往复运动方式驱动的各种辅助装置相配。可与本发明教导的手柄相连接的辅助或者附加装置(未明确示出)的其它例子包括但不局限于矫形固定装置、便携式吸入装置、闪光灯或者任何其它使用电源的医疗或现场装置。连接到手动或动力驱动器上的闪光灯可包括用于夜视的红灯或者白灯(未明确示出)。这些灯可为LED型。
图1A、2、3A-3C、6A和6B和1B示出了本发明的实施例，所示实施例包括可与根据本发明教导的针座可拆卸地接合的手动驱动器。如图6A所示的器械10f可包括形成一体件的带接头280的手柄12f。各种类型的螺纹连接和/或其它适配件都可满意地用于使驱动器10f与针座200可拆卸地接合。对于一些应用场合而言，螺纹连接188可形成在接头280内，用于与形成在针座200上的螺纹连接208可拆卸地接合。在图6A中，器械10f可包括从手柄12f延伸的穿透器或套管针220。
图6B示出了包括手柄12g和针座200的器械10g。对于例如由图6B所示的本发明的实施例而言，器械10g不包括穿透器或套管针。针座200可包括前述的具有形成于其内的侧口或者开口26的穿透器24。
图7为可满意地形成在针座200和静脉注射管150之间的路厄式适配件或路厄式接头的一个例子的示意图。外螺纹适配件40可插入到管150的一端内。外螺纹适配件40优选地包括锥形表面62，其被设计成与锥形表面64形成流体紧密封，其中所述锥形表面64形成有与端部210相邻的针座200。锥形表面62和64彼此配合，以形成流体紧密封路厄式适配件或接头的部分。路厄式锁紧螺母或路厄式卡箍133可用于使锥形表面62和64彼此牢固接合。路厄式紧固螺母133可与形成在与端部201相邻的针座200的外部上的螺纹208牢固接合。在针座200和相关的穿透器210已经置于所选择的插入位置处后，外螺纹路厄式适配件36可滑动地置于内螺纹路厄式适配件38内。路厄式适配件36和38优选地具有锥形表面，所述锥形表面彼此接合，从而在它们彼此之间形成大致的流体紧密封。路厄式锁133可用于牢固地接合，以在路厄式适配件36和38之间保持牢固接合。
虽然已经详细描述了本发明和它的优点，但是应该理解的是各种改变、替换和修改在不偏离由下面的权利要求所限定的本发明的精神和范围的情况下都可进行。

Claims (4)

1.一种用于穿透骨头和相关骨髓的器械，该器械包括：
具有驱动轴的手柄；
具有第一端(201)和第二端(202)的穿透器针座(200)；
具有第一端(181)和第二端(182)的接头(180)，该接头的第一端(181)用于可拆卸地接合驱动轴，该接头的第二端(182)用于可拆卸地接合穿透器针座(200)的第一端(201)；
外穿透器(210)，其连接于穿透器针座(200)的第二端(202)并且从穿透器针座(200)的第二端(202)延伸，该外穿透器(210)用于进入骨髓；
延伸穿过外穿透器(210)的纵向通道(184)；
螺纹连接(208)，该螺纹连接邻近穿透器针座(200)的第一端(201)设置，以便可拆卸地接合邻近接头(180)的第二端(182)设置的相关螺纹连接(188)；
接头(180)的第一端(181)具有开口(186)，该开口(186)用于接纳所述驱动轴；
设置在接头(180)的第一端(181)内的多个腹板(136)和空间(138)，腹板(136)从用于接纳驱动轴的开口(186)延伸；以及
各个空间(138)设置在各个腹板(136)之间。
2.根据权利要求1所述的器械，还包括：
内穿透器(220)，该内穿透器连接于接头(180)的第二端(182)并且从接头(180)的第二端(182)延伸；以及
当邻近穿透器针座(200)的第一端(201)设置的螺纹连接(208)与邻近接头(180)的第二端(182)设置的相关螺纹连接(188)可拆卸地接合时，该内穿透器(220)用于可滑动地布置在外穿透器(210)的纵向通道(184)内。
3.根据权利权利要求1或2所述的器械，其中，所述接头从包括磁体、O形环机构和球止动机构的组中选择。
4.根据权利要求2所述的器械，还包括从包括管心针和套管针的组中选择的所述内穿透器(220)；和/或
还包括从包括套管、中空管和中空钻头的组中选择的所述外穿透器。
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Patentee before: Tali FraX medical tools Co.,Ltd.