CN112657014A - 用于注射药物的皮下输注设备 - Google Patents
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Abstract
用于注射药物的皮下输注设备。提供了一种用于输送药物到使用者身体内的药物输送设备。可折叠毂(18)具有左翼(20)和右翼(22),其中毂在一端附接至管(16),并在相反端附接至针头(28)。至少一条第一肋(32)设置于左翼上,以及至少一条第二肋(34)设置于右翼上。在翼远离针头折叠回并捏到一起时,第一和第二肋阻止了在针头插入到使用者皮肤内期间翼相对于彼此的扭转和/或滑动,进而防止了由于翼的非期望运动引起的针头破损。
Description
本申请是申请日为2015年3月25日、申请号为201580017380.2(国际申请号为PCT/US2015/022494)、发明名称为“用于注射药物的皮下输注设备”的发明专利申请的分案申请。
技术领域
本公开总体上涉及用于注射药物的设备,以及更加特别地涉及一种用于将粘性液体药物皮下给药到使用者的身体内的医用流体输送设备。
背景技术
皮下输注设备在医疗领域中是公知的,其用于将选定药物给药到位于患者或使用者的皮肤下方的期望输注部位。这种输注设备中常常包括有管状套管或导管,其由毂支撑并从毂伸出,用于经由输送管路接受药物。典型地,毂包括刚好插入到皮肤表面下方的小针头,并保持就位达数天。
更加具体而言,这些输注设备提供了药物静态输送的替代方案,并允许药物穿过紧挨真皮和表皮下方的皮肤层给药。如本领域所公知的,皮下输注设备的这种使用减少了患者需要注射以接收经常给药的药物的次数。尽管不是所有药物都能够通过这种输注设备给药,但它们是给药的一种有效且方便的方式,而无需在患者上施加多次注射。
然而,一些药物是高粘性的(即,在3-10cP或厘泊的范围内),并且以高流量输送,而常规的皮下输注设备没有设计为以这样的速率输送该高粘性物质。因此,在该物质的输送期间可能会发生过度输送压力的累积,并且在输注期间会在针头或其紧邻区域发生堵塞。此外,由于输送设备中使用的针头通常弯曲约90度,在针头的弯曲部处或附近的扭结风险相对较高。
常用输注设备的另一问题是毂的运动会引起针头在使用期间破损。可折叠夹紧翼通常附接至毂,用于在将针头相对于皮肤表面以90度直接插入到期望输注部位时牢固地保持针头。具体而言,翼从针头折叠回并在两个手指之间捏到一起。有时,折叠的翼在插入步骤期间彼此抵靠滑动,使得针头插入是相当挑战性的。此外,如果针头制成为较小的直径,针头不会被牢固地支撑,并引起针头在使用期间破损。
因此,存在对改进皮下输注设备以促进插入步骤期间针头在皮肤上更加稳定保持的需求,以及减小输送步骤期间高粘性物质的流阻的需求。
发明内容
本公开涉及一种医用流体输送设备,其用于将粘性液体药物皮下给药至使用者或患者的身体内。该输注设备设计为用于减小在粘性液体或溶液至使用者皮肤的皮下空间内的输送步骤期间发生的压力下降(或流阻)。如下文中更加详细地描述的,由于毂和针头的几何形状,该输注设备以相比常规设备来说更高的流量输送粘性液体。
该输送设备的一个方面是针对高粘性液体(例如3-20cP)在皮下输送期间在从40至400ml/hr(或毫升/小时)的流量范围内实现了低流阻。具体而言,提供具有细管状壁的24G(或规格)针头用于适应粘性液体,以及该针头的中间区域是以预定曲率半径稍微弯曲,从而使得中间区域围绕位于毂的外端处的支撑区域。
另一重要方面是该输注设备提供了针头的牢固就位,其减小了对期望输注部位的扰动,并增强了输注期间的舒适度。多个基本对角布置的肋设置于毂的底侧上,用于阻止在使用者佩戴期间毂的非期望运动。更加具体而言,对角底侧肋以如下方式成角度,即,使得阻止朝向针头尖端的向前运动,而允许远离针头尖端的向后运动。此外,对角模式还针对针头安装之后的横向扰动稳定了毂。该布置减小了针头弯曲部上的剪切和/或法向应力。
该设备的另一方面是毂的顶侧包括至少两条肋,其中每一条分别定位在毂的左翼和右翼上。每条肋非对称地布置在翼上,从而使得在翼从针头折叠回并捏到一起时,两条肋阻止了在针头插入到皮肤内期间翼相对于彼此的扭转和/或滑动。因此,针头保持了插入期间的稳定和直进,阻止了由于翼的不期望运动引起的针头的破损。
附图说明
图1是该输注设备的顶部透视图,其表征具有顶侧肋的带翼毂;
图2是沿图1中线2-2截取的且基本在所指方向上的竖直剖面图;
图3是该毂的顶视图,其表征了成角度的底侧肋;
图4是沿图3中线4-4截取的且基本在所指方向上的竖直剖面图;
图5是准备将针头插入到输注部位时从针头折叠回的带翼毂的前视图;
图6是正插入到输注部位的该输注设备的透视图;
图7是输注期间的该输注设备的透视图;以及
图8是在针头插入到输注部位后的带翼毂的放大透视图。
具体实施方式
现在参照图1-2,该皮下输注设备总体指示为10,并设计用于皮下地输送药物到真皮和表皮下方。示例性药物可包括营养产品和中草药产品。能够预想到的是该设备10是一次性的。设备10中包括鲁尔帽12,其构造用于在一端接收液体,以及在相反端使用互补螺旋的螺纹部附接至母鲁尔连接器14,用于将帽和连接器可螺接地固定。为了运送粘性液体药物至输注部位,柔性细长管16在一端附接至母鲁尔连接器14,以及在相反端附接至具有左翼或第一翼20和右翼或第二翼22的可折叠毂18。
管16的示例性长度是大约24英寸,但也可以预想到的是能够利用任意的管长度来适合不同应用。通过相对于管的纵向轴线横向地调节滑动夹24来实现调节管16内粘性液体药物的流动。作为示例,在滑动夹24的中间设置可动释放槽26,从而通过相对于管16来选择性地滑动释放槽,使得夹能够在堵塞位置和非堵塞位置之间切换。
在优选实施方式中,带翼毂18是通过注塑模制等来模制的,从而使得毂及其连接元件整体地形成。然而,也可以预想到的是,毂18可通过化学胶粘剂、溶剂粘合、超声焊接或其他常用固定技术来附接至连接元件。更加具体而言,毂18在一端附接至管16,而在相反端附接至针头28,针头28在不使用时可滑动地配合至针头保护器30并由其保护。可预想到的是,在毂18模制后,针头28使用胶粘剂组装在毂18上。可替代地,毂18可以包覆模制(over-molded)在针头28上。
示例性针头尺寸是约24G,用于确保输注期间的舒适度,以及示例性针头长度基于应用可以是6、9或12mm(或毫米)中的一个。优选地,针头28具有薄的管壁,以适于粘性液体药物。
该毂18的一个重要方面是,毂的可折叠左翼20和右翼22中的每个具有至少一条顶肋32、34,这些肋沿相应翼的整个纵向长度延伸。每条顶肋32、34布置于相应翼20、22的上表面36上,从而使得在翼折叠时,顶肋32、34直接接触对应相对翼的上表面36。由此,设置于左翼20上的顶肋32接合右翼22的上表面36,以及相反地,设置于右翼22上的顶肋34接合左翼20的上表面36。
如示例性图1和5的实施方式中示意的,左或第一顶肋32与右或第二顶肋34非对称地设置,从而使得在翼20、22远离针头28折叠回并捏到一起时(图5),第一顶肋32与第二顶肋34并置。更加具体而言,第一顶肋32与毂18的细长中间部38平行地间隔第一预定距离DA(图1),而第二顶肋34与该中间部平行地间隔第二预定距离DB(图1),其中第一距离DA不同于第二距离DB。
例如,如图5实施方式中所最佳示出的,第一距离DA长于第二距离DB,以及第一肋32越过第二肋34行进,从而使得肋32、34在翼20、22折叠回时靠近彼此定位。因此,顶肋32、34的该特定构造阻止了翼20、22相对于彼此扭曲或滑动,进而减少了在针头插入到皮肤内期间针头28破损的风险。
现在返回图1-2,在中间部38的第一端处的第一插入开口40构造用于适应针头28的插入,以及在中间部的第二相反端处与管16流体连通的第二插入开口42构造用于适于管的插入。在优选实施方式中,管16插入到第一插入开口40内中间部38的大约一半长度,以减小针头28的总长度(图2)。
两个开口40、42提供了用于液体药物输送的通道。该通道针对高粘性液体(例如3-20cP)在皮下输送期间在40至400ml/hr之间的流量范围内提供了低流阻,而不会使流体压力下降超过10psi(或磅每平方英寸)。更加具体而言,具有薄管壁的示例性24G无菌针头28构造用于适于该粘性液体药物,以及针头28的中间区域44以预定曲率半径(例如,通常0.125”,以及不小于0.060”或不大于0.200”)稍微弯曲,从而使得针头的中间区域围绕定位于中间部38的第一插入开口40处或附近的支撑区域46。
优选地是,针头28的中间区域44以45至90度(名义上接近90度)的角度逐渐弯曲,从而使得支撑区域46支撑针头的弯曲中间区域。针头28的尖端从中间部38的第一插入开口40向外延伸,以使得针头的尖端横向于中间部的纵向轴线布置。因此,支撑区域46减小了针头破坏的风险,并且不仅在针头28插入皮肤期间,而且在附接至使用者身体时,提供了针对弯曲中间区域44的整体支撑。
现在参照图2-4和8,多个基本对角线布置的底肋48a、48b设置在每个翼20、22的下或底面50上,用于防止使用期间毂18不期望的运动。优选地是,底肋48a、48b平行地基本均匀间隔,并沿相应翼20、22的整个对角长度延伸。底肋48a、48b以如下方式成角度或倾斜,即使得阻止朝向针头28的尖端的向前运动,而允许远离针头尖端的向后运动。该特定布置减小了使用期间针头28的弯曲中间区域44上的剪切和/或法向应力。
在优选实施方式中,毂18的第一和第二翼20、22两者都具有底肋48a、48b,这些底肋以相对于中间部38的纵向轴线大约45度的角度定位在下表面50上。然而,肋48a、48b的一个重要方面是,布置于第一翼20下表面50上的每个底肋48a从第一翼的左侧朝向中间部38向上斜或倾斜到第一翼的右侧。在镜像方向上,布置于第二翼22下表面50上的每个底肋48b从靠近中间部38的第二翼的左侧向下斜或倾斜到第二翼的右侧。总体上,底肋48a、48b构造和布置为人字形或箭尾形模式,由此阻止了附接至使用者身体期间毂18的非期望运动。
由肋48a、48b提供的增强摩擦阻止了使用期间毂18自皮肤的滑动。然而对角线布置的肋48a、48b出于示意目的而示出,任意类型的滚花或纹路肋、脊、槽或块可预想用于部署作为翼20、22的下表面50上的摩擦构成,用于以该方式增强摩擦。此外,肋48a、48b的角度方向和/或间距可变化,以适应形势。
现在参照图5-7,以更详细方式示意了该输注设备的示例性使用。在将针头28插入到皮肤之前,使用者将翼20、22远离针头28折叠回,并将翼捏在两个手指之间。然后,使用者随后从针头28移除针头保护器30,并丢弃保护器(图5)。在准备插入时,使用者在期望输注部位处捏住一英寸的清洁皮肤,并将针头28以投掷动作以90度角度(图6)直接插入到输注部位内。接下来,使用者通过向后拉柱塞54来检查针头与注射器52的定位。如果在注射器52内观察到血液,则在使用一次性设备的情形下移除该设备10并丢弃。否则,使用者重复准备该设备10和输注部位的过程。在注射器52内没有观察到血液时,使用者将针头28固定就位,并由医疗护理专业人员引导开始输注。
尽管已经示出并描述了该输注设备的特定实施方式,本领域技术人员将理解的是,可以在不偏离本公开的情形下在其更广义方面上并如权利要求书所提出的对本发明做出改变和修改。
Claims (21)
1.一种皮下输注设备,其包括:
可折叠毂,所述可折叠毂具有左翼和右翼,所述毂被构造用于在第一端接收管,其中所述左翼和右翼中的每一个的下表面被构造用于放置为与使用者的皮肤相接触;
设置在所述毂的与所述第一端相反的第二端处的支撑区域;以及
附接至所述毂的针头,其中所述针头包括第一部分和第二部分,其中所述第一部分和第二部分通过所述针头的中间区域连接,所述中间区域以预定曲率半径弯曲,从而使得所述中间区域围绕所述支撑区域。
2.如权利要求1所述的输注设备,其中所述针头的所述中间区域以45至90度的角度弯曲,从而使得所述支撑区域支撑所述针头的弯曲的所述中间区域。
3.如权利要求1所述的输注设备,其中所述针头的第二部分包括所述针头的尖端,所述尖端从所述针头的中间区域向外延伸,以使得所述针头的尖端横向于所述毂的纵向轴线布置。
4.如权利要求3所述的输注设备,其中所述尖端垂直于所述毂的纵向轴线,并且其中所述第二部分是直的。
5.如权利要求1所述的输注设备,其中所述左翼和右翼中的每一个的下表面包括肋,所述肋被构造用于放置为与使用者的皮肤相接触,以防止所述毂在使用期间的非期望运动。
6.如权利要求1所述的输注设备,其中所述毂终止于所述针头的第一部分处。
7.如权利要求1所述的输注设备,其中所述毂被构造用于将所述管以大约一半接收到所述输注设备的中间部的纵向长度中,其中所述中间部包括所述毂和所述支撑区域。
8.如权利要求1所述的输注设备,其中所述针头延伸穿过所述毂的第二端。
9.一种皮下输注设备,其包括:
可折叠毂,所述可折叠毂具有左翼和右翼,所述毂被构造用于在第一端接收管;
设置在所述毂的与所述第一端相反的第二端处的支撑区域;以及
附接至所述毂的针头,其中所述针头包括第一部分和第二部分,第二部分包括所述针头的尖端,其中所述第一部分和第二部分通过所述针头的中间区域连接,所述中间区域以预定曲率半径弯曲,从而使得所述中间区域围绕所述支撑区域,并且其中所述毂终止于所述针头的第一部分处。
10.如权利要求9所述的输注设备,其中所述针头的所述中间区域以45至90度的角度弯曲,从而使得所述支撑区域支撑所述针头的弯曲的所述中间区域。
11.如权利要求9所述的输注设备,其中所述针头的第二部分包括所述针头的尖端,所述尖端从所述针头的中间区域向外延伸,以使得所述针头的尖端横向于所述毂的纵向轴线布置。
12.如权利要求11所述的输注设备,其中所述尖端垂直于所述毂的纵向轴线,并且其中所述第二部分是直的。
13.如权利要求9所述的输注设备,其中所述左翼和右翼中的每一个的下表面包括肋,所述肋被构造用于放置为与使用者的皮肤相接触,以防止所述毂在使用期间的非期望运动。
14.如权利要求9所述的输注设备,其中所述毂被构造用于将所述管以大约一半接收到所述输注设备的中间部的纵向长度中,其中所述中间部包括所述毂和所述支撑区域。
15.一种皮下输注设备,其包括:
中间部,所述中间部包括:
可折叠毂,所述可折叠毂具有左翼和右翼;和
设置在所述毂的与第一端相反的第二端处的支撑区域;
管,所述管插入到所述毂的第一端,进入所述中间部的纵向长度大约一半;以及
附接至所述毂的针头,其中所述针头包括第一部分和第二部分,其中所述第一部分和第二部分通过所述针头的中间区域连接,所述中间区域以预定曲率半径弯曲,从而使得所述中间区域围绕所述支撑区域。
16.如权利要求15所述的输注设备,其中所述针头的所述中间区域以45至90度的角度弯曲,从而使得所述支撑区域支撑所述针头的弯曲的所述中间区域。
17.如权利要求15所述的输注设备,其中所述针头的第二部分包括所述针头的尖端,所述尖端从所述针头的中间区域向外延伸,以使得所述针头的尖端横向于所述毂的纵向轴线布置。
18.如权利要求17所述的输注设备,其中所述尖端垂直于所述毂的纵向轴线,并且其中所述第二部分是直的。
19.如权利要求15所述的输注设备,其中所述左翼和右翼中的每一个的下表面包括肋,所述肋被构造用于放置为与使用者的皮肤相接触,以防止所述毂在使用期间的非期望运动。
20.如权利要求15所述的输注设备,其中所述针头的第一部分和中间区域具有的纵向长度为所述中间部的大约一半。
21.如权利要求15所述的输注设备,其中所述第一端包括适应所述针头的第一插入开口,并且其中所述第二端包括适应所述针头的第一部分的第二插入开口。
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