CN107530490B - 多针注射器 - Google Patents

多针注射器 Download PDF

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CN107530490B
CN107530490B CN201680014152.4A CN201680014152A CN107530490B CN 107530490 B CN107530490 B CN 107530490B CN 201680014152 A CN201680014152 A CN 201680014152A CN 107530490 B CN107530490 B CN 107530490B
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J·G·昂格尔
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Eligen Sales Co ltd
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Abstract

描述了一种改进的注射器针装置，该注射器针装置在组织扩张期间当被插入到皮下端口内时具有用于增加线性流动速率且因此减少手术时间的固有属性。本文公开了一种用于在组织扩张期间通过多个针将流体注射到皮下端口内的流体注射器装置，该流体注射器装置包括基座、连接所述针的导管以及基座流体注射系统，以增加线性流动速度和减少手术时间。

Description

多针注射器
相关申请的交叉引用
此申请要求享有2015年3月10日提交的美国临时申请No.62/131,064的权益，该美国临时申请通过整体引用的方式纳入本文。
技术领域
本发明总体上涉及在组织扩张和向皮下组织内注射流体期间使用多个针增加流动速率的装置和方法。
背景技术
现今乳房再造是在整形外科手术中执行的最常见程序之一。八分之一的女性在她们的一生中将患乳腺癌，她们中的大多数将经历再造。当前，联邦法律命令，必须为患有乳腺癌的任何女性提供再造。去年执行了96,000例乳房再造，乳房再造中的绝大多数是基于扩张器植入物的再造。需要注意的是，许多情况是双边的，且因此，每年在乳房再造中使用超过100,000个扩张器。
典型的乳房再造过程涉及在乳房切除(乳腺移除)之后将紧缩的组织扩张器放置在胸袋内。该扩张器包括一个端口，能够迫使无菌生理盐水通过该端口，从而导致该扩张器的体积增加。通常在手术室内将该扩张器填充有无菌生理盐水，之后闭合皮肤中的外科手术开口。然后患者在两周后返回诊所进行进一步扩张。由于该端口被皮肤覆盖，因此在端口定位器磁体的帮助下定位该端口。一旦该端口被定位，就将针穿过皮肤放置到该端口内并且注射无菌生理盐水。此程序每周进行一次，直到皮肤包膜被扩张到足够大的尺寸以使适当尺寸的乳房丘(breast mound)适应期望的植入物尺寸。通常，在准备好扩张器/植入物交换之前，单独执行扩张程序四至八次。
此程序不被限制于乳房再造。组织扩张器也被用在烧伤再造和需要皮肤扩张的多种其他类型的再造中。
与乳房扩张和其他类型的组织扩张相关联的最紧迫的问题是在当前的系统(诸如品牌为MENTOR的有翼的输液器)中使用与该系统的其余部分的管道(pipe)直径相比极其细的针。整个系统的瓶颈在于用来注射该端口的21g(gauge)的针。该针的内直径为0.51mm(外直径为0.81mm)，由于该端口的性质，按照制造商的说明(参见Mentor产品网站)，该针是最大可允许规格的针。细针导致无菌生理盐水的缓慢流动，并且要求更多的时间来填充组织扩张器。在手术室中的填充过程可能长达10至15分钟，在此时间期间，外科医生和护士必须耐心地等待扩张器填充同时患者仍然是伤口外露。简单地较大的针将会使硅胶空心并且将使端口泄漏，并且因此导致手术失败。
发明内容
本文公开了一种用于在组织扩张期间通过多个针将流体注射到皮下端口内的流体注射器装置，其包括基座、连接所述针的导管以及基座流体注射系统，以增加线性流动速度和减少手术时间。
本文还公开了一种在组织扩张期间通过多个针将流体注射到皮下端口内的方法，其包括基座、连接所述针的导管以及基座流体注射系统，以增加线性流动速度和减少手术时间。
附图说明
当结合附图考虑时，通过参考对优选实施方案的详细描述，本发明的另一些优点将变得明了：
图1是多针注射器装置的俯视图。
图2是多针注射器装置的主视图。
图3是用于针保护的塑料套筒的主视图。
图4是多针注射器装置的立体图。
图5是多针注射器装置的俯视图。
图6A-图6D是多针注射装置的一个实施方案的视图。独立地，图6A是该装置的集线器(hub)的立体图。图6B是多针注射器装置的横截面视图。图6C是该装置的集线器的俯视图。图6D是沿着图6B的线6D-6D取得的该装置的集线器的横截面视图。
图7A-图7D是多针注射器装置的一个实施方案的视图。独立地，图7A是该装置的集线器的立体图。图7B是该装置的集线器的俯视图。图7C是沿着图7B的线7C-7C取得的该装置的聚合式锥体的横截面视图。图7D是在增加的放大率下该装置的图7C的聚合式锥体的横截面视图。
图8A-图8C是具有插入到集线器内的多个针的装置的一个实施方案的视图。独立地，图8A是该装置的集线器的立体图。图8B是该装置的集线器的右侧视图。图8C是该装置的多个针和集线器的横截面视图。
图9A-9C是具有插入到集线器内的多个针的装置的一个实施方案的视图。独立地，图9A是该装置的集线器的立体图。图9B是该装置的集线器的右侧视图。图9C是该装置的聚合式锥体的横截面视图。
图10是该装置的集线器的一个实施方案的横截面视图。
图11是具有插入的多个针的装置的集线器的一个实施方案的横截面视图。
具体实施方式
呈现以下详细描述以使得本领域技术人员能够制造和使用本发明。出于解释目的，阐述了具体细节，以提供对本发明的透彻理解。然而，本领域技术人员将明了，实践本发明不需要这些具体细节。提供对具体应用的描述仅作为代表性实施例。对优选实施方案的多种修改是本领域技术人员容易明了的，并且在不脱离本发明的范围的前提下，本文限定的一般原理可以应用于其他实施方案和应用。本发明不意在被限制于示出的实施方案，而是符合与本文公开的原理和特征一致的最广泛的可能范围。
为了克服由于单个注射针造成的缓慢流动问题，本发明使用多个针。典型的注射端口的直径是将近3cm。因此，在大的单个针将导致失败时，可以同时将多个小的针容易地放置到硅树脂圆顶内，而不会破坏密封。本发明将通过允许与当前标准和唯一现有选项相比四倍的流动速度增加来解决极其小的针的问题，这是通过允许在蝴蝶形导管的端部处在一个构造内包含多个单独的针来实现，因此在手术室以及诊所中能够实现极大的时间节省。
本文公开了这样的一种允许提高流体进入组织扩张器内的流动速率的装置。该装置具有可以被同时插入到端口内的多个针，因此允许更多的流体流动到扩张器内。由于流动增加，因此填充组织扩张器的时间显著减少。
参考附图，图2例示了多针装置1，该多针装置1主要由从集线器5向外突出的针2和用于将该集线器连接到流体源的导管4组成。
针2从集线器5的第一端(注射侧)突出，使得它们大体上彼此平行。如图1和图4中示出的，所述针被隔开，使得它们全部都可以同时进入乳腺组织扩张器上的注射端口。在示出的实施例中，所述针之间隔开不超过五(5)毫米。针2可以比当前使用的针更短，或者它们可具有超薄的壁，因此减少增加流体进入组织扩张器内的流动所需的压力。可以在设备中使用允许液体流动的任何类型和尺寸的针，尽管在一个优选实施方案中，在装置1中使用的是标准皮下注射。
应理解，可以选择任何尺寸的集线器5来容纳多个针。在图6中描绘的实施方案中，集线器5的直径可以大到三(3)厘米，或其直径可以小到四分之一(0.25)厘米。另外，所述针可以通过压力固定到该集线器内，如图8A-图8C中示出的，或通过胶水固定到该集线器内如图9A-图9C中示出的。
集线器5的第二端6与该集线器的针侧相对地定位。第二端6被配置为接收IV导管(IV tubing)。在示出的实施例中，蝴蝶状IV导管将连接到第二端6。如图6中示出的，集线器5理想地将由塑料制成，并且具有能够有助于将针插入到注射端口内的塑料把手7。
如图4中示出的，该装置的优选实施方案具有平行定位的四个4.5cm长的21g的针2，所述针允许在组织扩张程序期间被精确地放置到皮下端口的硅树脂圆顶内，因此增加进入装置1内的线性流动速率。在此实施方案中，集线器5的优选实施方案的实际直径是大约5毫米。通过在集线器的第二端6之上拉伸导管来在第二端6处将导管6附接到集线器5。应理解，尽管集线器被示出为具有与导管的永久连接，但是它可以被构造成使得导管是可拆卸的。导管4在另一端处终止于鲁尔锁(leur lock)基座3的凹形连接内。
如图10中示出的，导管4到集线器5的连接的一个潜在实施方案包括用于导管4的进入端口，该进入端口具有与导管4的外直径相等的内直径。导管4被固定地附接到集线器5的第二端6，允许流体畅通无阻地流动通过导管4进入集线器5内，如图11中示出的。
为了使用装置1，鲁尔锁基座3被附接到流体源(诸如注射筒)。然后流体被推动通过导管4。
如图6A-图6D中示出的，装置1的优选实施方案具有渐变的引导壁8，该引导壁8在流体进入点处具有最窄的部分(导管4的直径)并且在流体退出点处具有最宽的部分(多个针2)，如图6B中绘制的。如图6C中示出的，由此成角度的引导壁8创建的该系统的直径的逐渐变化改善了层流。
当流体传递通过集线器5时，经由引导锥体9将该流体分配到多个针2内。该引导锥体9促进并且引导从集线器5的近侧端到针2内的流动。如果没有引导锥体9，流体将需要90度的方向改变才可以进入多个针2内。因此，以通过引导锥体9创建的渐变方式增加方向流动改善了层流，由此改善了装置1所实现的流动速率。
当所述针填充有流体时，所述针被插入到组织扩张器的注射端口内，并且然后流体填充该组织扩张器。
针2的潜在实施方案包括多个皮下注射针、圆锥形针、逐渐变细的针或1.5英寸的针，其中直径实际上从较大规格(即18g)逐渐变细到在针中发生端口刺穿的点附近的较小的21g的尺寸，因为仅进入该端口的部分需要21g的部段。另外，可以想到比标准针壁薄接近六(6)倍的薄壁针作为本发明的一个实施方案。
针2另一个潜在实施方案包括超薄的壁21g的针，所述针保持了相同的0.81毫米的外直径，但是内直径更大。
如图2中示出的，本发明的优选实施方案具有鲁尔锁基座3，以允许注射筒或其它流体源的固定附接。
如图2中示出的，本发明的优选实施方案由连接所述针的大约11英寸的IV导管4组成。然而，应理解，装置1可以包括能够连接针2的任何类型或长度的导管5。
如图6B和图7C-图7D中示出的，本发明的一个潜在实施方案由集线器5中的锥形切口(cut out)组成，该锥形切口以分级的方式引导流体从基座3流动到针2内。如图7D中示出的，此聚合式锥体10具有与集线器5的内直径减去引导锥体9的直径的二分之一相等的直径(公式：DAC＝1/2(D集线器-DDC))。因此，在每个针基座周围，存在一个渐变的壁，该渐变的壁由通向针的基座的直径在内部逐渐减小形成，以导引流体从引导壁8的最宽的部分流动到导引锥体9的基座并且增加层流速率。
IV导管4的其他潜在实施方案包括：无滚球锁，以止挡IV流动(IV flow)；较宽的导管，以允许改善流动，尤其是在蝴蝶状部段中；一系列单向阀，代替四向旋塞(stopcock)以创建“无接触”系统，该“无接触”系统允许抽吸和注射到端口内，而无需将装柄(stocking)手动地转动到正确的位置中；以及，自动注射器，其用预设量的生理盐水(即，35、50或60cc)预填充注射筒。所述单向阀将需要两个单向阀，以允许从IV包流入和通过针侧流出，并且该自动注射器可以由塑料把手和预加载弹簧创建，该预加载弹簧将注射筒拉回到期望的水平。
在另一个潜在实施方案中，本发明可以被用在需要高体积填充有流体或流体悬浮液(诸如在乳腺组织和皮下肿胀中)的皮下端口。
应理解，本发明还可以具有包括一系列阀、导管、注射筒和NaCL0.9％IV流体储存器的流体注射系统。
如图3中示出的，装置1可以包括塑料套筒11，以在不使用时保护针2。
为了证明本发明与当前标准相比的效率，在单盲(single-blind)研究中进行了流动速度测量，如表1中示出的。使用品牌为BRAUN的21G的有翼的针输液器7B3050进行对当前标准的测量。本发明采用了四个21g的皮下注射针。
表1.本发明的和当前标准的报告为注射时间的流动速率数据以及使用本发明而非当前标准的对应的时间节省。
Figure BDA0001400269430000061
Figure BDA0001400269430000071
如表1中示出的，进行的评估示出，多针注射器的平均流动速率比BRAUN 21g的有翼的针输液器7B3050大4.2倍。对于多针注射器，二十(20)次试验(在所述试验中装置被填充有60cc的流体)的平均注射时间为6.075秒，而BRAUN 21g标准花费了25.525秒。每个装置的标准差分别是0.71秒和1.96秒。此次评估的双侧(two-tailed)P值小于0.0001，这按常规标准考虑在统计上是极其显著的差异。此外，多针注射器减去当前标准的平均值等于19.450秒，对于从18.507至20.393的此差异，具有95％的置信区间。应理解，使用四个针的本发明实现大于四倍的注射速率增加。
基于此评估的结果，本发明的大于四倍的流动速度的增加使得繁重且痛苦的注射过程执行得更加舒适。由于注射需要较少的力，因此将导致较少的由于压靠肋骨或腹部而造成的身体瘀伤，并且将导致较少的拇指损伤。例如，拇指的基部关节经受从在压迫部位处创建的负荷增加13倍的负荷。如果用拇指以每平方英寸二十(20)磅的压力按压注射筒，拇指基部关节经受每平方英寸二百六十(260)磅，因此降低了由于进行这样的注射而造成关节炎发展的风险。最重要地是，更快的注射对应于更快的外科手术时间，从而患者处于麻醉的时间更少。因此，患者将具有更好的恢复周期、更低的感染机会以及可能更快从医院出院，这是由于本发明提供的时间节省。
此外，与多针注射器相关联的更快的过程将可能节省总手术时间，从而导致成本节省。例如，在双侧再造程序中，在中度的术中填充体积的情况下，更快的过程将可能节省十(10)分钟以上。以每分钟平均$62.00的成本经由2005年同行评议研究量化了此成本节省。此成本不包括麻醉成本，也不包括消耗品费用。因此，实际节省甚至更高。
另外，如表2中示出的，测量了在注射期间从端口释放的流体以确定本发明的泄漏。
表2.在插入到端口的中心内并且从端口的中心移除三十(30)次之后多针注射器的泄漏数据
Figure BDA0001400269430000081
如表2示出的，在检查九十(90)天后，未发现组织扩张器泄漏。该多针注射器被用在三(3)个不同的组织扩张器样品(1个Mentor；2个Allergan)中，并且同样地流体被注射到该装置内。该装置被翻转成倒置，以使得端口在最低点处，并且然后被擦干。在相对于重力端口处在最低点的情况下，采用用手动压力进行对多针注射器的压缩。执行了可看得见且可感知的测试，以寻找从端口释放的流体的任何证据。缺少与本发明相关联的泄漏数据进一步指示本发明的设计的可靠性和效率。
虽然本文将本发明描述为与乳腺组织扩张器一起使用，但是可以想到，本发明可以被用在具有可以容纳多针的注射端口的任何组织扩张器或任何其他设备中。
如在本文的权利要求和说明书中使用的术语“包括”、“包含”以及“具有”应被认为指示开放的组，其可能包括未指定的其他要素。术语“一”、“一个”以及词语的单数形式应被认为包括相同词语的复数形式，使得这些术语意味着提供一个或多个某物。术语“一个”或“单个”可以被用来指示意在一个或仅一个某物。类似地，当意在具体数目的事物时，可以使用其他具体整数值，诸如“两个”。术语“优选地”、“优选的”、“优选”、“可选地”、“可以”以及类似的术语被用来指示提到的项、条件或步骤是本发明的可选的(不是必需的)特征。
已经参考多个具体且优选的实施方案和技术描述了本发明。然而，应理解，在保持在本发明的精神和范围内的同时，可以做出许多变体和改型。本领域普通技术人员将明了，除本文具体描述的方法、设备、设备元件、材料、程序和技术以外的方法、设备、设备元件、材料、程序和技术可以被应用于如本文宽泛公开的发明的实践，而无需依靠过多实验。本文描述的方法、设备、设备元件、材料、程序和技术的所有本领域已知的功能等同物意在被本发明涵盖。每当公开一个范围，所有子范围和个体值都意在被涵盖。本发明不受公开的实施方案限制，包括在附图中示出的或在说明书中示例的任何实施方案，所述实施方案是通过实施例的方式而不是通过限制的方式给出的。
虽然已经参考有限数目的实施方案描述了本发明，但是得益于此公开内容的本领域技术人员将理解，可以设想不脱离如本文公开的发明的范围的其它实施方案。因此，本发明的范围应仅由所附权利要求限制。
整个此申请中的所有参考文献(例如包括公布的或授权的专利或等同物、专利申请出版物以及非专利文献文件的专利文件或其他源材料)通过整体引用的方式纳入本文，如同通过引用的方式单独地纳入，达到每个参考文献与本申请中的公开内容至少部分地不一致的程度(例如，部分地不一致的参考文献除了该参考文献的部分地不一致的部分以外通过引用的方式纳入)。

Claims (17)

1.一种流体注射设备，包括：
a.多个针；以及
b.一个集线器，其具有第一端部、第二端部、位于第二端部处的多个针基座，以及从第二端部延伸的引导锥体，其中所述多个针基座至少部分地围绕所述引导锥体，所述引导锥体在远离第一端部的方向上逐渐变细，以用于使流动朝着多个针基座转向并且引导从集线器的近侧端到针内的流动，使得经由引导锥体将流体分配到多个针内，所述多个针中的每一个与多个针基座中的对应的一个针基座流体连通，且从该集线器的所述第一端部突出，以及
基座部件，其与集线器的第二端部是分立的并且能够附接至集线器的第二端部，当所述引导锥体附接到基座部件时所述引导锥体在多个针基座的上游延伸到基座部件的腔内，所述基座部件包括用于将所述设备连接到流体源的入口。
2.根据权利要求1所述的设备，其中所述多个针由两个针组成。
3.根据权利要求1所述的设备，其中所述多个针由三个针组成。
4.根据权利要求1所述的设备，其中所述多个针由四个针组成。
5.根据权利要求1所述的设备，其中所述多个针由五个针组成。
6.根据权利要求1所述的设备，其中所述多个针由六个针组成。
7.根据权利要求1所述的设备，其中所述针由皮下注射针组成。
8.根据权利要求1所述的设备，其中所述针由21g的针组成。
9.根据权利要求1所述的设备，其中所述针是圆锥形的。
10.根据权利要求1所述的设备，其中所述集线器由塑料制成。
11.根据权利要求1所述的设备，其中所述集线器包括用于使得能够将所述针更容易地插入到注射端口内的把手。
12.根据权利要求1所述的设备，其中所述集线器具有围绕多个针基座的每个基座的渐变的壁，其中渐变的壁包括逐渐减小的直径以增加层流。
13.根据权利要求1所述的设备，其中所述针被配置为同时进入组织扩张器的注射端口。
14.一种流体注射设备，包括一个集线器、导管和一个基座部件，该集线器具有第一端部、第二端部和沿着所述第二端部形成的多个针基座，所述第一端部被配置为接收多个针，以允许所述多个针从该集线器的所述第一端部突出，所述多个针中的每一个与多个针基座中的对应的一个针基座流体连通，该集线器还包括引导表面，该引导表面朝着针基座成角度并具有锥形形状，该锥形形状具有对应于导管直径的最窄部分且在流体退出点处具有最宽部分，所述针基座被布置成在引导表面周围，以增加流体沿着引导表面朝着针基座的层流流动，所述基座部件与集线器的第二端部是分立的并且能够附接至集线器的第二端部，当所述引导表面附接到基座部件时所述引导表面在多个针基座上游延伸到基座部件的腔内，所述基座部件包括用于将所述设备连接到流体源的入口。
15.一种多注射器装置，其包括集线器、集线器中的多个针基座、附接到集线器并与多个针基座流体连通的多个针、实心引导锥体，以及基座部件，所述引导锥体从集线器延伸并在远离多个针基座的方向上逐渐变细，以用于使流动朝着多个针基座转向并且引导从集线器的近侧端到针内的流动，使得经由引导锥体将流体分配到多个针内，所述基座部件与集线器的第二端部是分立的并能够附接到集线器的第二端部，当所述引导锥体附接到基座部件时所述引导锥体在多个针基座上游延伸到基座部件的腔内，所述基座部件包括用于将所述装置连接至流体源的入口。
16.根据权利要求15所述的装置，其中实心引导锥体逐渐变细成截头圆锥尖端，该截头圆锥尖端在多个针基座上游延伸到基座部件的腔内。
17.根据权利要求15所述的装置，其中所述基座部件包括导管连接区段和介于导管连接区段和腔之间的中心区段，在所述管连接区段处具有第一直径，所述中心区段包括小于第一直径的第二直径。
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US20160263358A1 (en) 2016-09-15
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US20200038133A1 (en) 2020-02-06
CN107530490A (zh) 2018-01-02
RU2715685C2 (ru) 2020-03-02
CA2976544A1 (en) 2016-09-15
US10433928B2 (en) 2019-10-08
RU2017133044A3 (zh) 2019-08-08
WO2016145230A1 (en) 2016-09-15
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SG11201706680SA (en) 2017-09-28
BR112017019272A2 (pt) 2018-05-02

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