CN108430537A - 具有滑动运动副的贴片式注射器 - Google Patents

具有滑动运动副的贴片式注射器 Download PDF

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CN108430537A
CN108430537A CN201680072344.0A CN201680072344A CN108430537A CN 108430537 A CN108430537 A CN 108430537A CN 201680072344 A CN201680072344 A CN 201680072344A CN 108430537 A CN108430537 A CN 108430537A
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syringe
needle body
kinematic pair
path
skin
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CN108430537B (zh
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O·卡比里
P·H·诺顿
R·希斯基安胡
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Western Medicine Services To Israel Branch
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Western Medicine Services To Israel Branch
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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
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  • Anesthesiology (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Ceramic Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

一种注射器，包括具有针体的至少一个流体储存器、与皮肤附接并连接所述流体储存器的表面，其连接通过至少一个第一运动副和一个第二运动副，所述运动副中至少一个的一部分可滑动或具有互锁臂。所述第一运动副的所述可滑动部分的平移路径的至少一部分和所述第二运动副的平移路径的一部分相对于彼此成角度。

Description

具有滑动运动副的贴片式注射器
技术领域和背景技术
本发明在一些实施例中涉及一种自注射器，更具体地但非排他地涉及贴片式自注射器。皮下(SC)注射是一种在皮肤下施用药物的方法，通常进入皮肤和肌肉之间的脂肪组织。目前生物制剂的皮下注射趋势使使用者能够在家自注射，其使用诸如可重复使用的和一次性的笔、自动注射器和粘附在皮肤表面的贴片注射器的皮下注射生物制品的自动注射器。
在许多情况下，重新配制的药物可能更浓，有时更粘稠并且所需的注射容积大于1mL。对于高粘度产品，在10秒内输送可导致注射疼痛，这可能导致使用者不遵循其治疗方案。对于使用者而言，在持续超过10秒或几分钟的注射期间，很难保持笔或其他直立式注射器静止并位于注射的正确角度。因此，用于自注射SC注射的贴片自动注射器或自注射器正变得越来越普遍。
另外的背景技术包括专利号6,843,782的美国专利和专利号5,858,001的美国专利。
发明内容
根据本发明一些实施例的一方面，提供一种注射器，包括一个或多个流体储存器，所述流体储存器具有针体、与皮肤附接并连接所述流体储存器的表面，其连接通过一个或多个第一运动副和一个或多个第二运动副，所述运动副之一的一个或多个部分可滑动。
根据本发明的一些实施例，所述第一运动副的可滑动部分的平移路径的一个或多个部分以及所述第二运动副的平移路径的一部分相对于彼此成角度，并且所述第二运动副的所述部分的所述平移路径的一个或多个部分阻挡所述第一运动副的所述部分的所述平移路径的一个或多个部分。
根据本发明的一些实施例，所述第二运动副的平移路径的一个或多个部分是弯曲的。根据本发明的一些实施例，所述第二运动副的平移路径的一个或多个部分是正弦的。根据本发明的一些实施例，所述第二运动副的平移路径的一个或多个部分是蛇形线的(serpentine)。
根据本发明的一些实施例，一个或多个所述运动副具有相对于表面的至少两个自由度，一个或多个是旋转自由度，两个自由度均在同一平面。当所述的流体储存器相对于所述表面旋转时，由至少所述两个自由度限定的所述针体的一个或多个部分的行进路径的一个或多个部分沿着直线穿过所述皮肤的表面。根据本发明的一些实施例，所述部分是所述针体的斜面的近边缘。根据本发明的一些实施例，所述针体的倾斜角基本平行于直线路径。根据本发明的一些实施例，所述针体形成直径(φ)的进入孔，直径(φ)是针体直径(φ’)的两倍。
根据本发明的一些实施例，当所述的流体储存器相对于所述表面旋转时，由至少所述两个平移路径限定的所述针体的一个或多个部分的行进路径的一个或多个部分沿着直线穿过所述皮肤的表面。根据本发明的一些实施例，一个或多个平移路径与所述皮肤平行并且所述针体沿路径行进，路径的一个或多个部分由旋转自由度和平移自由度的结合限定。
根据本发明的一些实施例，所述针体沿路径行进，路径的一个或多个部分由一个或多个旋转自由度和平移自由度的结合限定。根据本发明的一些实施例，所述的部分是所述针体的尖端。根据本发明的一些实施例，所述的部分是所述针体的斜面的上端。
根据本发明的一些实施例，至少两个自由度限定行进路径，在行进路径上，所述针体的一个或多个部分以相对于直线小于3度的角度穿过皮肤表面。根据本发明的一些实施例，所述的部分是尖端，尖端包括面向前(远离所述流体储存器本体)的倾斜开口并且所述针体的一个或多个部分切于由旋转自由度限定的曲线。根据本发明的一些实施例，所述针体的一个或多个部分垂直于由旋转自由度限定的曲线半径。
根据本发明的一些实施例，一个或多个运动副包括一个或多个槽内销铰链。根据本发明的一些实施例，一个或多个槽定向为平行于皮肤表面。根据本发明的一些实施例，一个或多个第一运动副和第二运动副定位在注射器的后端(非针端部)和注射器的前端(针端部)之间。
根据本发明的一些实施例，所述流体储存器还包括一个或多个成角度的头部和与所述头部端部连接的柱塞，其中一个或多个运动副包括一个或多个与表面连接的带槽缸体并且尺寸设置成并安装成滑动地容纳成角度的头部和柱塞。
根据本发明的一些实施例，所述针体的一个或多个部分是弹性的。根据本发明的一些实施例，所述针体的一个或多个部分是弯曲的。根据本发明的一些实施例，一个或多个运动副包括一个或多个凹槽并且一个或多个突出部可滑动地容纳在凹槽内。根据本发明的一些实施例，一个或多个运动副包括弹性构件。
根据本发明一些实施例的一方面，提供一种注射器，包括一个或多个流体储存器，所述流体储存器具有针体、与皮肤附接并连接所述流体储存器的表面，其连接通过一个或多个第一运动副和一个或多个第二运动副，一个或多个运动副包括至少两个互锁臂。根据本发明的一些实施例，一个或多个互锁臂枢接于皮肤表面。根据本发明的一些实施例，互锁臂彼此枢接。
根据本发明的一些实施例的一方面，提供了一种注射方法，包括相对于皮肤表面旋转流体储存器的针体，与此同时沿平移自由度移动针体，并且将针体的一个或多个部分沿直线插过皮肤表面。根据本发明的一些实施例，将针体的一个或多个部分以偏离直线小于3度的角度穿过皮肤表面。根据本发明的一些实施例，所述平移自由度相对于皮肤是轴向的。根据本发明的一些实施例，所述平移自由度的移动是前后方向。根据本发明的一些实施例，同时旋转和移动针体包括调整进入皮肤的针体的行进路径或倾斜角。根据本发明的一些实施例，还包括在调节前将针体倾斜面上的背压最小化到80-85％之间的背压。根据本发明的一些实施例，还包括在皮肤上形成直径(φ)的进入孔，直径(φ)是针体直径(φ’)的两倍。
除非另外定义，否则本文使用的所有技术和/或科学术语具有与本发明所属领域的普通技术人员通常理解的相同的含义。尽管在本发明的实施例的实践或测试中可以使用与本文所述的方法和材料类似或等同的方法和材料，但是下面描述示例性的方法和/或材料。如果发生冲突，将控制包括定义在内的专利说明。另外，这些材料、方法和实例仅是说明性的，并非意在限制。
附图说明
这里仅通过举例的方式参照附图来描述本发明的一些实施例。现在具体参照附图详细说明，需强调所示出的细节是作为示例并且出于对本发明的实施例的说明性讨论的目的。就此而言，对于本领域技术人员而言，利用附图所作的描述对于可以如何实施本发明的实施例是显而易见的。
在附图中：
图1A和1B是本领域已知的自注射器的剖面图简图；
图2是借由固定长度半径将切点连接至旋转点的曲线路径形成的简化图；
图3A、3B和3C是可选运动副的简化图，其将通过半径连接到旋转点的切点的曲线路径转换成基本上直线的运动路径；
图4A、4B和4C是自注射器的示例性实施例操作阶段的侧视简化图；
图5A、5B、5C、5D和5E是，自注射针体以及在针体刺入皮肤时运动副对针角度的影响的侧视简化图；
图5F和5G是显示注射器运动副调节对进入皮肤的斜面背压的效果曲线图；
图6A、6B、6C和6D是自注射器的示例性实施例操作阶段的侧视剖视简化图；
图7A、7B、7C和7D是自注射器的示例性实施例操作阶段的侧视剖视简化图；
图8A、8B和8C，其为自注射器的示例性实施例的侧视和俯视简化图；以及
图9A和9B是根据本发明的自注射器的示例性实施例的侧视简化图。
具体实施方式
本发明在一些实施例中涉及一种自注射器，更具体地但非排他地涉及贴片式自注射器。
本发明的一些实施例的一个方面涉及一种自注射器，其具有连接表面至少一部分的至少两个运动副，所述表面附接至皮肤和流体储存器，其中一个运动副的至少一部分相对于运动副其他部分可滑动。在一些实施例中，至少一个运动副包括滑动运动副。在一些实施例中，第二运动副的平移路径限制第一运动副的部分的平移路径。在一些实施例中，限制取决于平移路径之间的角度。在一些实施例中，角度是锐角。在一些实施例中，该角度小于90度。在一些实施例中，两个运动副的平移路径位于同一平面上。
在一些实施例中，流体储存器是注射筒。在一些实施例中，流体储存器是药筒。在一些实施例中，流体储存器是药水瓶。
在一些实施例中，运动副包括至少一个槽。在一些实施例中，运动副包括至少一个导轨。在一些实施例中，运动副包括至少一个凹槽。在一些实施例中，运动副包括至少一个套筒。在一些实施例中，套筒围绕针体定位。在一些实施例中，套筒包括至少一个槽。在一些实施例中，流体储存器和框架可相对于彼此滑动。在一些实施例中，至少一个运动副包括至少两个互锁臂。
在一些实施例中，至少一个运动副设置在注射器的后端(非针头端)。在一些实施例中，至少一个运动副设置在注射器的前端(针头端)处。在一些实施例中，至少一个运动副设置在注射器的后端(非针头端)和前端(针头端)之间。在一些实施例中，保持皮肤的进入点同时注射针的刺入角度改变。在一些实施例中，注射针沿着至少两个平面同时移动，保持皮肤进入点同时，改变其相对于行进路径的刺入角度。
在一些实施例中，至少一个运动副包括平面运动副。在一些实施例中，至少一个运动副包括非平面运动副。在一些实施例中，运动副注射器同时包括平面运动副和非平面运动副。在一些实施例中，接合平面运动副和非平面运动副的至少部分位于同一平面上，该平面垂直于旋转轴线。在一些实施例中，平面运动副和非平面运动副不在同一平面上，该平面垂直于旋转轴线。在一些实施例中，平面运动副包括槽内销运动副。在一些实施例中，至少一个运动副具有一个自由度。在一些实施例中，运动副具有两个自由度。在一些实施例中，运动副具有超过两个的自由度。在一些实施例中，运动副具有至少一个轴向线性自由度。在一些实施例中，运动副具有至少一个旋转自由度和一个轴向自由度。在一些实施例中，旋转自由度和轴向线性自由度在同一平面上。在一些实施例中，至少一个运动副防止框架和流体储存器相对于彼此围绕垂直于旋转轴线的旋转轴的旋转运动。
本发明的一些实施例的一个方面涉及一种自注射器，其具有连接皮肤表面至少一部分的至少两个运动副，所述表面附接到皮肤和流体储存器上，一个或多个运动副包括至少两个相对于表面的自由度，至少一个是旋转自由度。在一些实施例中，两个自由度都在同一平面上。在一些实施例中，该平面垂直于皮肤。
本发明的一些实施例的一个方面涉及流体储存器针体的至少一部分的行进路径，其由连接表面的至少一部分的至少两个运动副限定，所述表面附接到皮肤和具有针体的流体储存器。在一些实施例中，一个或多个运动副包括相对于表面的至少两个自由度，其中至少一个是旋转自由度。在一些实施例中，由两个自由度限定的针体的至少一部分的行进路径沿着直线穿过皮肤的表面。
本发明的一些实施例的一个方面涉及一行进路径，在行进路径上流体储存器针体沿着直线穿过皮肤，并且相对于直线具有小于3度的角度。在一些实施例中，流体储存器的针体的至少一部分的刺入角度由连接表面至少一部分的至少两个运动副限定，表面附接到皮肤和具有针体的流体储存器。在一些实施例中，一个或多个运动副包括相对于表面的至少两个自由度，其中至少一个是旋转自由度。在一些实施例中，针体包括斜面尖端。在一些实施例中，针尖处的斜面面向前(远离流体储存器)。在一些实施例中，针体是弯曲的。
为了更好地理解本发明的一些实施例，如附图的图3-8所示，首先参考如图1A和1B(统称为图1)所示的自动注射装置的构造和操作，图1A和图1B是本领域已知的自动注射器的剖面图简图。
如图1A所示，自注射器102包括流体储存器104和针体106，针体106定向为大致垂直于流体储存器104的纵向轴线。流体储存器104经由铰链110可旋转地连接到基座108，铰链110固定就位，即不能从固定位置移动。在操作中并且如图1B所示，基座108抵靠皮肤表面112放置，并且流体储存器104围绕铰链110沿箭头150指示的方向旋转，从而使针体106在入口点170处穿透皮肤的表面112。
在将针体106插入皮肤中时，针体106的尖端114遵循由箭头190指示的曲线路径，其分力是指向流体储存器旋转轴线运动的向内径向分量(也参见图2)。在一些情况下，针尖114的向内指向的径向运动伴随曲线路径190可在入口点170与最终静止点175之间拉伸并且可能撕裂组织116。如图1B所示，尖端114包括斜面开口118，该斜面开口118面向流体储存器的主体或与其连接的旋转轴线。沿入口点170与最终静止点175之间的针尖114的曲线路径190，组织可被迫进入开口118并阻塞针尖114。
图2是示出形成诸如图1B的路径290的曲线路径的简化图。在图2中，切点202通过固定长度半径(r)连接到旋转点(P)。旋转点(P)固定就位，即不能从其位置移动。当点202沿箭头250指示的方向穿过水平线(h)移动，固定长度半径(r)和固定在位的旋转点(P)限制点202在曲线路径270上运动。沿着曲线路径270的运动可以包括朝向旋转点(P)的向内径向的运动分量275。在一些情况下，点202可以代表针体106的尖端114并且水平线(h)可以代表皮肤的表面112。
在详细解释本发明的至少一个实施例之前，应当理解的是，本发明在其应用中不一定限于后文描述和/或附图和/或示例中阐述的部件的构造和布置和/或方法的细节。本发明能够具有其他实施例或以各种方式实践或执行。
在一些自注射器中，注射针体行进路径的形状是重要的。如上所述，在一些情况下，基本上沿着直线(线性)行进路径穿透组织的针体(最小化运动的向内径向分量275)可减轻组织损伤(例如过度的组织拉伸和可能的沿着穿过组织的行进路径撕裂(例如，116，图1B))。如上所述，图3A和图3B(统称为图3)是示出可选机构的简图，这些机构将借由半径(r)连接到旋转点(P)的切点的行进路径从曲线路径转换为基本上直线(线性)运动路径并且使运动的向内径向分量275最小化。在一些实施例中，切点包括针体的一部分，该针体垂直于半径(r)。
在一些实施例中，从水平线(h)以上到水平线(h)以下的切点304的曲线运动可以转化成箭头352指示方向的沿着切向直线路径306的线性运动。在图3A所示的一些示例性实施例中，半径(r)包括至少一个弹性构件308，例如允许半径(r)范围的弹簧。在一些实施例中，弹性构件308可以是线性弹性构件。在一些实施例中，弹性构件308延伸将点304保持在路径306上。可替代地并且可选地，在图3B中示出的一些示例性实施例中，半径(r)具有固定的长度并且允许旋转点(P)根据需要移动接近路径306以将点304维持在路径306上。
在如图3A、3B和3C所示的示例中，3A、3B和3C是沿着与圆相切的路径行进的针体的空间指向示意图，点304可代表针的尖端，水平线(h)可代表皮肤的表面(112)。在一些示例中，限制因素(例如，弹性构件308(图3A)或物理障碍物的阻力)可限制点304到路径306的平移。
在较小的尺度上，如图3C所示，并且在本公开的别处更详细地解释，在一些情况下，由于机械限制，运动副(例如，图3A和3B中所示的运动副操作机构)可以消除沿着路径306行进的针体尖端的向内径向分量275。然而，如图3C所示，当沿着直线路径306行进时针体的主体可能稍微旋转，并且针体的尖端(切点403)可能仍然微小地偏离路径306。在一些示例中，限制因素(例如弹性构件308(图3A)或物理障碍物的阻力)可能将穿过水平线(h)处针体的角度维持在距路径306小于3度处。如图3A-3C所示，并且在本公开的别处更详细地解释，在一些实施例中，旋转点(P)包括运动副，运动副相对于附接到皮肤的表面具有两个或更多个的自由度，其中至少一个是旋转自由度。在一些实施例中，两个自由度均在同一平面上。在一些实施例中，该平面垂直于皮肤。在一些实施例中，平移自由度限定直线。在一些实施例中，平移自由度平行于所述皮肤。
如本公开别处所解释的，注射的不适主要由针体刺穿皮肤所沿的路径以及针体相对于其进入皮肤的穿刺路径的角度的本质引起。例如，沿着曲线路径穿透皮肤的针(也参见1B)可能使皮肤和皮下组织破裂，从而导致使用者感到不适。另外或可选地，相对于皮肤刺穿的直线路径过度倾斜的针也可能导致使用者不适。
现在参考图4A，4B和4C(统称为图4)，这些图是侧视简化图，示出了在将其针体引入皮肤期间自注射器的示例性实施例的三个连续操作阶段。在一些实施例中，自注射器400是粘附到使用者皮肤表面的贴片自注射器。在一些实施例中，自注射器包括将表面404和流体储存器408与至少一个针体410联接的至少一个运动副402/420。在一些实施例中，框架404被附接到使用者的皮肤。在一些实施例中，表面404包括框架。在一些实施例中，运动副402/420具有至少一个自由度。在一些实施例中，运动副402/420具有相对于表面404的至少两个或更多的自由度。在一些实施例中，至少一个自由度是旋转自由度，例如围绕运动副402/420旋转流体储存器408，使得针体410穿过皮肤412的表面并刺穿皮肤412。在一些实施例中，两个自由度均在垂直于皮肤412的同一平面上。在一些实施例中，至少一个自由度包括平移运动自由度，例如可选地轴向地前后方向移动流体储存器408(即，以注射器400后端(非针头端)朝注射器400前端(针头端)的方向，或与之相反)。
在图4的示例性实施例中，流体储存器408由支撑板406支撑，该支撑板406装配成至少支撑流体储存器408和至少一个针体410。在示例性实施例中，自注射器400包括旋转地连接支撑板406和框架404的一个或多个运动副402/420。图4中描绘的实施例的运动副402包括至少一个第一销405，其连接到支撑板406并且经由框架404中的细长槽418可滑动地接合框架404。细长槽可以是直线形、曲线形、蛇形线形、正弦线形或任何几何形式，其被计算为使针体410以直线行进并以本公开别处所述的适当调整的倾斜角度(β)进入皮肤412的表面。在一些实施例中，细长槽418纵向定向，平行于框架404的长轴线、流体储存器408的长轴线和皮肤表面412，从而为第一销405提供可选地轴向地前后方向移动的自由度[即，以注射器400后端(非针头端)朝注射器400前端(针头端)的方向，或与之相反]。在一些实施例中，销405和细长槽418在垂直于皮肤表面412的平面上形成平行于框架404长轴的槽内销运动副。在一些实施例中，销405和细长槽418在平行于皮肤表面412的平面上形成平行于框架404长轴的槽内销运动副。
在一些实施例中，支撑板406安装成支撑至少一个流体储存器408，该流体储存器408具有从流体储存器408成角度的颈部416突出的至少一个针体410。在一些实施例中，针体410的至少一部分垂直于流体储存器408的纵向轴线。在一些实施例中，针体410的至少一部分垂直于支撑板406。
在图4所示的示例性实施例中，支撑板406相对于框架404围绕运动副402以箭头450所示的方向的旋转引起由其支撑的流体储存器408的共同旋转，从而使针体410朝向表面412移动。在一些实施例中，运动副402向前[即，从注射器400的后端(非针头端)朝向注射器400的前端(针头端)]向后支撑流体储存器408相对于框架404(可选地，轴向)的移动。
在一些实施例中，注射器400包括至少第二运动副420，第二运动副420包括附接到支撑板406并且经由框架404中的细长槽424可滑动地接合框架404的第二销422。在一些实施例中，运动副420限制运动副402的前向和后向，可选地轴向移动。限制水平取决于运动副402和420的平移的路径之间的角度(α)。在图4中，平移路径分别由每个运动副402/420中的细长槽418/424限定。在图4的示例性实施例中，细长槽424定向为以角度(α)沿着斜坡426向前倾斜，其角度(α)为运动副402和420的平移路径之间40度和90度之间、50度和80度之间、60度和70度之间、大于90度或小于40度或中间角度。当支撑板406相对于框架404绕运动副402旋转时，细长槽424沿着斜坡426引导销422，该斜坡又可选地沿轴向将支撑板和第一销405向上拉至由角度(α)限定的极限。
支撑板406和流体储存器408的向前移动以及支撑板406和由其支撑的流体储存器408相对于框架404的旋转同时进行有助于将具有角度的颈部416在流体储存器408的前端(针头端)的曲线运动转化成本公开别处描述的针尖414的线性切向运动，如本公开别处所述。如图4A、4B和4C，这些图代表针尖414引入皮肤的连续阶段，支撑板406和流体储存器408继续旋转，可选地从升高的角度状态旋转到与皮肤表面412平行的最终水平状态，针尖414沿由本公开中别处讨论的至少两个自由度限定的路径行进、接近并最终刺穿皮肤的表面412。可选地，针尖414沿着切向直线路径452移动，类似于图3A和3B中箭头455指示方向的路径306。
运动副402/420的组合作用的潜在优点是形成针尖414穿过皮肤表面412行进的直线路径，并且减少了在将针体引入皮肤期间使用者的不适。
现在参考图5A、5B、5C、5D和5E(统称为图5)，均为侧视图，示出了针体410的尖端414的简化图示，显示了如图3所示的运动副在尖端414刺入皮肤412的点处的针角度的示例性实施例的效果。
如本公开其他部分所述，在一些实施例中，运动副402/420不仅可以减少针体尖端运动的向内径向分量275，而且还可以补偿针体410的主体行进直线路径306的倾斜或角度。角度(β)越小，使用者在将针体410引入皮肤时所经历的不适越少。如图5A所示，在一些实施例中，针体410具有角度(β)的角度。在一些实施例中，角度(β)相对于直线路径452可小于5度，小于3度，小于1度，大于5度或中间角度。
在一些实施例中，针体410相对于直线路径452的角度(β)使针尖414与直线路径452略微偏离。图5A-5E中，由于参考行进路径452的针体角度的改变，尖端414可能稍微偏离路径452一偏差距离(d)。在一些实施例中，测量针尖414进入皮肤表面412的入口点504到皮下组织的末端412的最终静止位置506之间的偏差距离(d)。
可选地，为了避免针体开口堵塞的可能(如本其他部分所讨论的)和产生高背压，在一些实施例中，针尖414的倾斜开口502面向前方(即远离被贴附的流体储存器的本体)。
图5B示出了一个示例性实施例，其中运动副402/420被适当地调节，使得针体410的倾斜角度接近平行于路径452，导致针尖414与路径452的最小偏差(d)并且在皮肤表面412内产生最佳尺寸入口孔506。针尖414从入口点504到最终静止位置575的运动压缩尖端414之后(即，在流体储存器418主体侧面)的组织508并且向前拉伸组织510(即，在远离流体储存器418主体的一侧)并且远离尖端414开口502，减少了背压抵抗注射的发生以及针尖414的开口堵塞的发生。
在一些实施例中并且如图5C所示，当针体410的倾斜角度(β)被适当地调节时，在到达注射部位的最终静止位置575时形成最佳尺寸的进入孔506，其孔具有的直径(Φ)为针体410的直径(Φ')的1.5至2.5倍之间，例如Φ＝1.5Φ'、Φ＝2Φ'、Φ＝2.25Φ'、Φ＝2.35Φ'、Φ＝2.5Φ'或中间倍数。
最佳尺寸的进入孔506的潜在优点在于，与皮肤表面的撕裂相关的疼痛是最小的，并且在整个注射周期中皮肤表面中的开口的小直径最小化被注射的血管注射剂泄漏的风险以及到皮肤表面以外的风险。
在一些实施例中并且如图5D所示，运动副402/420的过补偿(即运动副402的过度向前移动)可能使针体414过度地向后倾斜(即朝向流体储存器418的主体倾斜)，从而向尖端414前方(即，在远离流体储存器418本体的一侧)压缩组织510并向尖端414后面(即，在流体储存器418本体的一侧)拉伸组织508，增加了背压抵抗注射的发生并且阻塞了如箭头552所示的针尖414的斜角开口502。
在一些实施例中，并且如图5E所示，在运动副402/420的补偿(即，运动副402的向前移动不足)可能使针体414过度向前倾斜(即远离流体储存器418的主体倾斜)，拉伸皮肤表面412并且扩大由刺穿皮肤41产生的孔512。如箭头554所示，大穿刺孔可允许注射材料从注射部位泄漏。
在一些实施例中，运动副402/420被定向使得至少斜面502的近端(上端)525(图5A)遵循直线路径452。在一些实施例中，运动副402/420被定向为使得针体410的至少中心纵向轴线遵循直线路径452。一旦已知路径452和皮肤表面412之间的交叉点(即，针尖414进入皮肤表面412的进入点504)，运动副402/420可被设定为使得运动副402/420/808的至少部分的向前运动使得针体410尖端412保持在路径452上并且保持针体410的角度尽可能平行于路径452，使得尖端412在期望入口点504处进入皮肤的表面412。
至少运动副402/420的组合作用的潜在优点是针尖414穿过皮肤表面412行进形成的直线路径，保持针体410的角度尽可能与行进路径平行并且减少了在将针体引入皮肤期间使用者的不适。
角度(β)越小，使用者在将针体410引入皮肤时所经历的不适越少。在一些实施例中，由针体410倾斜引起的针尖414与路径452的偏差的距离(d)在0.1mm-1.0mm、0.2mm-0.5mm，0.3mm-0.4mm，小于0.1mm，大于1.0mm或任何中间距离。
图5F和5G是显示注射器运动副调节(例如，补偿)对由进入皮肤的针体行进路径引起的针体斜面背压的效果曲线图。图5F描绘了由于缺乏调节(例如补偿进入皮肤的针体行进路径和/或倾斜角)而导致的注射到皮肤中的血管注射剂的高背压(阻力)(也参见图5D)。如图5F所示，大约51秒后停止注射，并在86秒进行第二次尝试。在两种情况下，注射阻力最初在0psi和33psi之间以指数方式增加，然后在24psi和43-45psi之间以对数方式增加。
然而，如图5G所示，在施加补偿的情况下，15秒和29秒之间背压的较小初始峰值之后跟随整个注入周期中3-4psi水平的低稳定水平。图5F和图5G示出当穿过皮肤表面时的针体行进路径和倾斜角度的适当调整补偿可将背压减小到非补偿针体行进路径和倾斜角度的80-85％的水平。
现在参考图6A，6B和6C(统称为图6)，这些图是侧视局部剖面简化图，示出了在将其针体引入皮肤期间自注射器的示例性实施例的三个连续操作阶段。还参考图6D，其是沿着W-W截面的剖视图，从箭头650所指示的方向的运动副602接合视图的简化图示。
在一些实施例中，自注射器600是粘附到使用者皮肤表面的贴片自注射器。在图6的示例性实施例中，自注入器600包括一个或多个运动副602并且旋转地连接流体储存器408和框架404。另外并且可选地，运动副402旋转地连接支撑板406和框架404。
在一些实施例中，运动副602包括至少一个开槽缸体604，其联接到框架404并且其尺寸设计成可滑动地且可选地部分回转容纳成角度的头部416的柱塞606。在一些实施例中，缸体602沿着背面方向(面对流体储存器408)开槽。在一些实施例中，可选地当自注射器600从升高的角度状态旋转到平行于皮肤表面412的最终水平状态时，槽608被安装成允许成角度的头部416自由地上下移动缸体604。可选地，在一些实施例中，槽608被安装成允许成角度的头部416在缸体604内部分自由旋转。在一些实施例中，弯曲缸体602壁以滑动地容纳成角度的头部416和针尖414的曲线路径。
当支撑板406和流体储存器408相对于框架404旋转时(可选地从升高的角度状态旋转到平行于皮肤表面412的最终水平状态)，柱塞606滑动地接合缸体604的壁并且沿缸体604壁引导柱塞606使得针尖414接近并且最终刺穿皮肤的表面412，可选地沿着大体上垂直于皮肤表面412的切向直线路径452并且沿由箭头455指示的方向移动。可选地，柱塞606沿着弯曲缸体604壁的运动可导致流体储存器408和附接到其上的支撑板406的向前运动。
在一些实施例中，柱塞606由弹性材料即软聚合物或弹性体(例如硅酮)制成。
可选地，图6中示出的示例性实施例可以包括类似于运动副402的运动副，其操作参照图4进行解释，不再赘述。
现在参考图7A，7B和7C(统称为图7)，这些图是侧视简化图，示出了在将其针体引入皮肤期间自注射器的示例性实施例的三个连续操作阶段。还参考图7D，其是沿着W-W截面的剖视图，从箭头750所指示的方向的运动副702视图的简化图示。
在一些实施例中，自注射器700是粘附到使用者皮肤表面的贴片自注射器。在图7的示例性实施例中，自注入器700包括一个或多个运动副702并且旋转地连接流体储存器408和框架404。另外并且可选地，运动副402旋转地连接支撑板406和框架404。
在一些实施例中，运动副702包括理论缸壁704的至少一部分，该理论缸壁704具有至少一个联接到框架404的槽，并且尺寸设计成滑动地容纳成角度的头部416。在图7的示例性实施例中，理论缸壁704包括至少一个连接到成角度的头部416的销722，并且销722经由细长槽724沿着理论缸壁704可滑动地接合缸体704。在图7的示例性实施例中，弯曲细长槽724以允许理论缸壁704滑动地容纳成角度头部416和针尖414的曲线路径。可选地，图7中示出的示例性实施例可以包括类似于运动副402的运动副，其操作在本公开的其他地方进行解释并且将不会重复。
当支撑板406和流体储存器408相对于框架404旋转时(可选地从升高的角度状态旋转到平行于皮肤表面412的最终水平状态)，销722滑动地接合理论缸壁704槽724并且沿槽724引导销606使得针尖414接近并且最终刺穿皮肤的表面412，可选地沿着大体上垂直于皮肤表面412的切向直线路径452。可选地，销722沿着弯曲槽724壁的运动可导致流体储存器408和附接到其上的支撑板406的向前运动。
可选地，图7中示出的示例性实施例可以包括类似于运动副402的运动副，其操作在本公开其它部分进行解释，不再赘述。
现在参考图8A和8B，其为自注射器的示例性实施例的侧视和俯视简化图。在一些实施例中，自注射器800是粘附到使用者皮肤表面的贴片自注射器。
在图8A、8B和8C所示的示例的实施例包括运动副，该运动副包括与运动副702相似的一个或多个运动副802，其旋转地连接流体储存器408和框架404。运动副702的操作在本公开中的其他部分进行了解释，不再赘述。
图8A和8B示出了自注射器的示例性实施例，其包括至少一个运动副802，运动副802包括框架404中的凹槽804和附接到支撑板406并滑动地容纳在凹槽804内的突出部806。在一些实施例中，凹槽804位于支撑板406中，并且突出部806附接至框架404。在一些实施例中，运动副802位于框架404表面和支撑板406表面之间。在一些实施例中，运动副802位于平行于皮肤表面412的框架404表面和支撑板406的表面之间。在图8A和8B的示例性实施例中，突出部806呈翅片形式，然而，突出部806可具有适于与凹槽804滑动接合的任何几何形状。凹槽804平行于流体储存器408的纵向轴线设置。
当支撑板406和流体储存器408相对于框架404旋转时(可选地从高角度状态到平行于皮肤表面412的最终水平状态)，突出部806滑动地接合凹槽804并沿着凹槽804引导突出部806。在一些实施例中，如参照图6所解释的，由于通过运动副602销622沿着弯曲槽624的运动而拉动流体储存器408和支撑板406向前，因此槽804的宽度确定允许支撑板40相对于框架404旋转的程度。
在图8C所示的示例的实施例，注射器800包括至少一个与运动副602相似的运动副，其旋转地连接流体储存器408和框架404。运动副602的操作在本公开中的其他部分进行了解释，不再赘述。在一些实施例中，注射器800包括支撑板406和框架404之间的一个或多个运动副808。在一些实施例中，运动副808包括一个或多个弹性构件810。在图8C中的一些示例的实施例中，弹性构件由弹簧代表。
在一些实施例中，当支撑板406和流体储存器408旋转时(可选地从升高的角度状态旋转到平行于皮肤的表面412的最终水平状态时)，弹性构件810阻止流体储存器408和支撑板406相对于框架404向前移动和旋转，因为它们通过运动副602销622沿着弯曲槽624的运动被向前拉动，如参照图6所解释的。在图8C所示的示例性实施例中，流体储存器408和支撑板406处于最终的水平状态(图6C)，这由流体储存器408和支撑板406被运动副802向前拉动而在支撑板406和框架404之间形成的显而易见的间隙850。
在一些示例性实施例中，当流体储存器408和支撑板406处于其升高的角度状态时，运动副808可以是处于压缩状态的弹簧。在这样的构造中，一旦完成注射过程并且流体储存器408和支撑板406旋转回到其升高的角度状态，运动副808弹性构件810可以辅助重新逼近流体储存器408和支撑板406和框架404。在一些实施例中，当流体储存器408和支撑板406处于升高的角度状态时，运动副808可以是静止状态下的弹簧。
现在参考图9A和9B，其为自注射器的示例性实施例的侧视简化图。在一些实施例中，自注射器900包括粘附到使用者皮肤表面的贴片自注射器。在一些实施例中，自注射器包括将表面904和流体储存器908与至少一个针体910联接的至少一个运动副902/920。在一些实施例中，框架表面904包括被附接到使用者的皮肤的框架906。在一些实施例中，运动副902/920具有至少一个自由度。在一些实施例中，运动副902/920具有相对于框架表面904的至少两个或更多的自由度。在一些实施例中，至少一个自由度是旋转自由度(例如旋转流体储存器908)，使得针体910穿过皮肤412的表面。在一些实施例中，两个自由度均在垂直于皮肤412的同一平面上。在一些实施例中，至少一个自由度包括平移运动自由度，例如可选地沿轴前后方向移动流体储存器908和针体910[即，以注射器900后端(非针端部)朝注射器900前端(针头端)的方向，或与之相反]。
在图9A和9B的示例性实施例中，诸如注射筒、药水瓶、药筒的流体储存器408由支撑板906支撑，该支撑板406被安装成至少支撑流体储存器908和至少一个针体910。在示例性实施例中，自注射器900包括旋转地连接支撑板906和框架904的一个或多个运动副902/920。如图9A和9B所述的实施例中的运动副902包括至少一个运动副，其包括至少两个互锁臂。
在一些实施例中，支撑板906被安装以支撑至少一个流体储存器908，该流体储存器908具有从流体储存器408成角度的颈部916突出的至少一个针体910。在一些实施例中，针体910的至少一部分垂直于流体储存器908的纵向轴线。在一些实施例中，针体910的至少一部分垂直于支撑板906。
在一些实施例中，注射器900包括至少第二运动副920，第二运动副920包括附接到支撑板906并且经由框架904中的细长槽924可滑动地接合框架904的销922。细长槽可以是直线形、曲线形、蛇形线形、正弦线形或任何几何形式，其被计算为使针体410以直线行进并以本公开其他地方所述的适当调整的倾斜角度(β)进入皮肤412的表面。
在一些实施例中，运动副920限制运动副902的运动。限制水平取决于运动副902和920的平移的路径之间的角度(α)。图9A和9B中，运动副902/920的平移路径由运动副920中的细长槽918、一个或多个互锁臂950的长度以及将互锁臂互相连接以及支撑板906和框架904枢转点的旋转限制限定。在图9A和9B的示例性实施例中，细长槽924定向为以角度(α)沿着斜坡926向前倾斜，其角度(α)为运动副902和920的平移路径之间40度和90度之间、50度和80度之间、60度和70度之间、大于90度或小于40度或中间角度。当支撑板906相对于框架904绕运动副902旋转时，细长槽924沿着斜坡926引导销922，该斜坡将支撑板和第一运动副902向上拉至由角度(α)限定的极限。
运动副902/920的组合作用的潜在优点是形成针尖914穿过皮肤表面412行进的直线路径，并且减少了在将针体引入皮肤期间使用者的不适。
术语“包括”，“包括有”，“包含”，“包含于”，“具有”及其结合意味着“包括但不限于”。
术语“由...组成”表示“包括并限于”。
术语“基本上由...组成”是指组合物、方法或结构可以包括附加的成分、步骤和/或部分，但仅指附加成分、步骤和/或部分不会实质上改变要求保护的组合物、方法或结构的基本特征和新颖特征。
如本文所用，除非上下文另外明确指出，否则单数形式“一”，“一个”和“该”包括复数指代。
在整个申请中，本发明的实施例可以参考范围形式来呈现。应该理解的是，范围形式的描述仅仅是为了方便和简洁，并且不应该被解释为对本发明范围的不灵活的限制。因此，范围的描述应被视为具体公开了所有可能的子范围以及该范围内的单个数值。例如，诸如“1至6”范围的描述应该被认为具有特定公开的子范围，例如“从1到3”、“从1到4”、“从1到5”、“从2到4”、“从2至6”，“从3至6”等。以及该范围内的个别数字，例如1、2、3、4、5和6。适用于所有范围的宽度。
本文中无论何时指示数字范围(例如“10-15”、“10至15”或由这些另一范围指示链接的任何一对数字)，其旨在包括指示范围限制内的任何数字(分数或整数)，包括范围限制，除非上下文另有明确规定。在本文中，第一指示数字和第二指示数字之间的“范围/排列/范围于”和从第一指示数“到”，“达到”，“直到”或“通过”(或另一个这样的范围指示术语)第二指示数字可互换地使用，并且旨在包括第一指示数字和第二指示数字以及其间的所有分数和整数。
除非另外指明，否则本文使用的数字和基于其的任何数字范围是本领域技术人员所理解的合理测量精确度和舍入误差内的近似值。
应该认识到，为了清楚起见，在单独实施例的上下文中描述的本发明的某些特征也可以在单个实施例中组合提供。相反地，为了简洁起见，在单个实施例的上下文中描述的本发明的各种特征也可以单独地或以任何合适的子组合或者在本发明的任何其他描述的实施例中合适地提供。除非实施例在没有那些元件的情况下不起作用，否则在各种实施例的上下文中描述的某些特征不被认为是那些实施例的基本特征。
虽然已经结合其具体实施例描述了本发明，但对于本领域技术人员而言，许多替代、修改和变化将是显而易见的。因此，旨在涵盖落入所附权利要求的精神和广泛范围内的所有这些替代、修改和变化。
本说明书中提及的所有出版物、专利和专利申请在此通过引用整体并入本说明书，其程度如同每个单独的出版物、专利或专利申请被具体和单独地指出通过引用并入本文。另外，本申请中任何参考文献的引用或标识不应被解释为承认这种参考文献可作为本发明的现有技术。在使用章节标题的范围内，不应将其解释为限制。

Claims (39)

1.一种注射器，其特征在于，包括：
至少一个流体储存器，所述流体储存器包括针体；
与皮肤附接并连接所述流体储存器的表面，其连接通过
至少一个第一运动副和一个第二运动副，所述运动副中至少一个的一部分可滑动。
2.根据权利要求1所述的注射器，其特征在于，所述第一运动副的所述可滑动部分的平移路径的至少一部分和所述第二运动副的平移路径的一部分相对于彼此成角度。
3.根据权利要求2所述的注射器，其特征在于，所述第二运动副的所述部分的所述平移路径的至少一部分限制所述第一运动副的所述部分的所述平移路径的至少一部分。
4.根据权利要求2和3的任一所述的注射器，其特征在于，所述第二运动副的所述平移路径的至少一部分是弯曲的。
5.根据权利要求2和3的任一所述的注射器，其特征在于，所述第二运动副的所述平移路径的至少一部分是正弦的。
6.根据权利要求2和3的任一所述的注射器，其特征在于，所述第二运动副的所述平移路径的至少一部分是蛇形线的。
7.根据权利要求1所述的注射器，其特征在于，所述运动副的至少一个具有相对于所述表面的至少两个自由度，至少一个是旋转自由度。
8.根据权利要求7所述的注射器，其特征在于，两个自由度均在同一平面。
9.根据权利要求7所述的注射器，其特征在于，当所述的流体储存器相对于所述表面旋转时，由至少所述两个自由度限定的所述针体的行进路径的至少一部分沿着直线穿过所述皮肤的表面。
10.根据权利要求9的所述注射器，其特征在于，所述的部分是所述针体的斜面的近边缘。
11.根据权利要求1-10任一所述的注射器，其特征在于，所述针体的倾斜角基本平行于所述直线路径。
12.根据权利要求1-10任一所述的注射器，其特征在于，所述针体在皮肤上形成直径(φ)的进入孔，直径(φ)是针体直径(φ’)的两倍。
13.根据权利要求1-3任一所述的注射器，其特征在于，当所述的流体储存器相对于所述表面旋转时，由至少所述两个平移路径限定的所述针体的至少一部分的行进路径的至少一部分沿着直线穿过所述皮肤的表面。
14.根据权利要求2所述的注射器，其特征在于，至少一个平移路径的至少一部分平行于所述皮肤。
15.根据权利要求4所述的注射器，其特征在于，所述针体沿一路径行进，路径的至少一部分由所述旋转自由度和所述平移自由度的结合限定。
16.根据权利要求4所述的注射器，其特征在于，所述针体沿一路径行进，路径的至少一部分由所述旋转自由度和所述平移自由度中的至少一个限定。
17.根据权利要求9的所述注射器，其特征在于，所述的部分是所述针体的尖端。
18.根据权利要求9所述的注射器，其特征在于，至少两个自由度限定行进路径，在行进路径上，所述针体的至少一部分以相对于所述直线小于3度的角度穿过皮肤表面。
19.根据权利要求9所述的注射器，其特征在于，所述的部分是尖端，所述尖端包括面向前(远离所述流体储存器主体)的倾斜开口。
20.根据权利要求4所述的注射器，其特征在于，所述针体的至少一部分切于由所述旋转自由度限定的曲线。
21.根据权利要求4所述的注射器，其特征在于，所述针体的至少一部分垂直于由所述旋转自由度限定的曲线半径。
22.根据权利要求1所述的注射器，其特征在于，至少一个所述运动副包括至少一个槽内销铰链。
23.根据权利要求22所述的注射器，其特征在于，至少一个槽定向为平行于所述皮肤表面。
24.据权利要求1所述的注射器，其特征在于，第一运动副和第二运动副的至少一个定位在所述注射器的后端(非针端部)和注射器的前端(针端部)之间。
25.根据权利要求1所述的注射器，其特征在于，所述流体储存器还包括至少一个成角度的头部和与所述头部尖端连接的柱塞，其中至少一个所述运动副包括至少一个与所述表面连接的带槽缸体并且尺寸设置成并安装成滑动地容纳所述成角度的头部和柱塞。
26.根据权利要求1-3、7-10和14-25的任一所述的注射器，其特征在于，所述针体的至少一部分是弹性的。
27.根据权利要求1-3、7-10和14-25的任一所述的注射器，其特征在于，所述针体的至少一部分是弯曲的。
28.根据权利要求1-3、7-10和14-25的任一所述的注射器，其特征在于，至少一个运动副包括至少一个凹槽和可滑动地容纳于所述凹槽的至少一个突出部。
29.根据权利要求1-3、7-10和14-25的任一所述的注射器，其特征在于，至少一个运动副包括弹性构件。
30.一种注射器，其特征在于，包括：
至少一个流体储存器，所述流体储存器包括针体；
与皮肤附接并连接所述流体储存器的表面，其连接通过
至少一个第一运动副和一个第二运动副，至少一个运动副包括至少两个互锁臂。
31.根据权利要求30所述的注射器，其特征在于，所述互锁臂的至少一个枢接于所述表面。
32.根据权利要求28-31所述的任一注射器，其特征在于，所述的互锁臂彼此枢接。
33.一种注射方法，其特征在于，包括：
相对于皮肤表面旋转流体储存器的针体；
同时沿着平移自由度移动所述针体；及
将所述针体的至少一部分沿直线插过皮肤表面。
34.根据权利要求33所述的方法，其特征在于，将针体的至少一部分以偏离所述直线小于3度的角度穿过皮肤表面。
35.根据权利要求33所述的方法，其特征在于，所述的平移自由度相对于皮肤是轴向的。
36.根据权利要求35所述的方法，其特征在于，所述的平移自由度的中的所述移动是前后方向的。
37.根据权利要求33所述的方法，其特征在于，所述同时旋转和移动所述针体包括调整进入皮肤的针体的行进路径和/或倾斜角。
38.根据权利要求37所述的方法，其特征在于，还包括在调节前将所述针体倾斜面上的背压最小化到80-85％背压之间的背压。
39.根据权利要求37所述的注射器，其特征在于，还包括在皮肤上形成直径(φ)的进入孔，直径(φ)是针体直径(φ’)的两倍。
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