CN102231995A - 注射装置 - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
- A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
- A61M25/0625—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard with a permanent connection to the needle hub, e.g. a guiding rail, a locking mechanism or a guard advancement mechanism
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3293—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle hub
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/04—Skin
Abstract
注射装置(10)包括:注射器(12),其具有主体(14)以及开口远端,在该主体中设有活塞;以及布置在主体内供活塞注射的粘性流体。设有针头组件(26),其包括具有鲁尔接头的插管(30),该鲁尔接头与所述注射器远端相接合,所述鲁尔接头包括轴套。通过注射器远端的内螺纹和轴套的外螺纹的方式提供了配接,所述螺纹的螺距足以防止所述轴套与所述注射器远端在注射所述粘性流体的过程中分离。另外,布置在所述轴套内的阶梯型腔室进一步防止所述轴套与所述注射器远端在注射所述粘性流体的过程中分离。
Description
发明人:Ahmet Tezel、Kevin McNerney、Christopher S.Mudd、Blake R.Storie以及Bastien Mandaroux
相关申请
本申请要求享有于2008年12月2日提交的美国临时专利申请No.61/119,298的权利,以及于2008年12月19日提交的美国临时专利申请No.61/139,430的权利,上述各个申请的全部内容都通过这种明确引用的方式纳入本文。
背景技术
本发明总体涉及用于修正皮肤轮廓缺陷和老化的非手术装置,更具体地,涉及一种能够将皮肤填充物(dermal filler)通过插管(cannula)引入人体的体表位置的注射装置。
通过使用非常细的注射器针头(syringe needles),诸如透明质酸基制剂的皮肤填充物(例如JuvedermTM)已用于治疗鼻唇褶(nasallabial folds)、唇部增大、泪槽,以及用于面部丰隆(facialvolumizing)。
皮肤填充物具有高粘性,这提供了高效地——优选基本均匀地——将皮肤填充物悬挂进入体表位置中。
优选使用相对小尺寸和小规格的针头来输送皮肤填充物,以便减少并发症以及缩短恢复时间。然而,这与相对高粘性的皮肤填充物同时存在会产生针头组件与注射器分离的问题,这是由于为了从注射器中将所述皮肤填充物穿过细针头推出并将其推进病人体内,作用于高粘性皮肤填充物的活塞产生了高压。
本发明通过提供如下的注射装置来克服这个问题,即所述注射装置消除或者大大降低了在手术过程中针头组件/注射器分离的可能性。
发明内容
根据本发明的注射装置总体包括注射器,该注射器具有主体以及开口远端,在该主体中设有活塞。
设有针头组件,其包括插管以及与注射器远端相接合的鲁尔接头。所述针头或者插管——下文称为“插管”——具有约18到约25的规格或者更大规格。所述鲁尔接头包括轴套(hub),该轴套具有支撑所述插管的远端和与所述注射器远端相配合的近端。
在一个实施方案中,本发明还包括粘性流体,例如透明质酸基的皮肤填充物,其布置在所述注射器的主体内,并且可被所述活塞通过所述插管注射进人体或动物体的体表位置。
除了在锥形注射器锥部和所述轴套的锥形内表面之间的配接以外,例如在所述轴套和所述注射器远端之间的配接是通过布置在所述注射器远端的内螺纹和布置在所述轴套上的外螺纹提供的。所述内螺纹具有如下螺距,该螺距足以防止所述轴套与所述注射器远端在将所述粘性流体注射进入人体或动物体的体表位置的过程中分离。
更具体地,在一个实施方案中,所述内螺纹具有的螺距在约2mm到约5mm之间。例如,所述内螺纹具有的螺距为约3mm。所述内螺纹可以是双线螺丝螺纹(double lead screw threads)。另外,布置在所述轴套上的外螺纹也可是双线螺丝螺纹,并且所述双线螺丝螺纹提供如下优点,其允许每旋转所述轴套一圈,就使所述轴套能够行进两倍距离与所述注射器远端相配接。在其他实施方案中,所述内螺纹具有的螺距为约2.0mm、约3.0mm、约3.5mm、约4mm、约4.5mm或者约5mm。另外,所述外螺纹可具有的螺距为约2.0mm、约3.0mm、约3.5mm、约4mm、约4.5mm或者约5mm。
在一个具体实施方案中,正如下文将进一步详细说明的,所述外螺纹包括单圈双线螺丝螺纹。
另外,在所述轴套内布置有一个腔室,例如阶梯型腔室。所述腔室不仅用于减小注射器内的死区(dead space),还显著降低了所述轴套与所述注射器远端在操作活塞通过插管喷射所述粘性流体的过程中分离的概率。从而,所述腔室可被视为轴套保持腔室(hub retentioncavity)。
附图说明
通过结合附图考虑下面的说明,将更好地理解本发明的优点和特征,在所述附图中:
图1图示了使用根据本发明的注射装置用于将粘性流体注射进人的体表位置,总体示出了注射器,该注射器具有带活塞的主体以及针头组件;
图2是图1中示出的注射器的横截面图,其更加清晰地示出了注射器主体,以及带有与注射器的远端相接合的鲁尔(luer)接头的针头组件,以及布置在所述注射器主体内的粘性流体;
图3是在鲁尔接头轴套和注射器的远端之间配接的放大横截面图,其清楚示出了得以能够配接的布置在注射器远端上的内螺纹以及沿着轴套的外螺纹,以及布置在轴套内的一个腔室,该腔室被构造为轴套保持腔室。
图4是轴套的端视图,示出了双线螺丝;
图5是针头组件和注射器主体的开口远端的放大横截面视图,示出了与针头组件轴套的锥形内表面相接合的锥形注射器锥部;以及
图6是接合有注射器的开口远端的针头组件的横截面图。
具体实施方式
参照图1,其示出了根据本发明的注射装置10,该装置包括具有主体14的注射器12,主体14内布置有活塞18。
另外参照图2和图3,注射器14包括开口远端22以及针头组件26。所述针头组件包括连同护套34的插管30以及可与注射器开口远端22相接合的鲁尔接头38,所述鲁尔接头包括轴套42,所述轴套具有远端46以及与注射器远端22配合的近端50。
内螺纹52、54和外螺纹56、58使得能够配接。螺纹52、54的螺距(P)使得一旦操作活塞18就能够将粘性流体62通过插管30喷出,而没有如图1所示的在喷出粘性流体62的过程中轴套42与注射器开口远端22相分离。
一些实施方案中,粘性流体62是皮肤填充物。一些实施方案中,所述粘性流体是粘度在约50,000厘泊到约500,000厘泊之间的透明质酸基的流体,所述粘度是使用受控应力流变计(RS600 TA仪器)和锥形板几何结构(40mm,2°)在约25℃下测量的。在一些实施方案中,所述粘性流体是粘度大于约130,000厘泊的透明质酸基皮肤填充物。
当以13mm/min(挤压速度)以及规格在21G到32G之间的针头,使用圆柱牵引测试(traction column test)(Versatest,Mecmesin)时,所述粘性流体可具有在约5N一直到200N之间的挤压力,更具体地,在约10N到约150N之间的挤压力。
在一个示例性实施方案中,轴套螺纹52、54的螺距在约2mm到约5mm之间。优选地,所述螺距是约3mm。所述螺纹52、54和56、58优选地为至少双线螺丝螺纹,但是也可使用三线螺纹,甚至四线螺纹。如图4中最清晰示出的,在一个具体实施方案中,螺纹52、54具有两个相互成180°径向偏差的螺纹起始点66、68。
如上所述,这使得轴套42能够与注射器开口远端22快速接合。
在一个实施方案中,轴套42由低弹性材料制成,例如,丙烯酸树脂或聚碳酸脂,而非一般用于注射器轴套的聚丙烯,如下文关于针头保持测试所述。这进一步增强了对轴套46与注射器开口远端22分离的防范。
参照图5和图6,轴套42包括由轴套42的内表面84和台阶(step)88限定的轴套保持腔室80,由此提供独特的阶梯状内表面。当所述轴套被旋转到注射器上并且如图6所示最大限度地就位时,锥形注射器锥部90未能到达台阶88,从而形成一个被台阶88缩小的死区92。在锥部90和内表面84(其也是锥形的)之间的接合形成它们之间的密封。小的死区减少了不能被给药的流体的量。这非常重要,因为通过注射来给药的流体通常都非常昂贵。
台阶88出乎意料地防止了或极大地降低了在注射粘性流体62的过程中轴套42从注射器锥部90以及注射器开口远端22分离的可能性。
即是说,正如在如下的对比试验中发现的,具有在轴套42的腔室轴套保持腔室80中形成的台阶88时,平均分离力明显较大。
本试验中利用的测试方法使用Omnica公司专为力矩设置和分离测试而设计的设备。
力矩设置单元利用数控的马达和力矩传感器,将针头轴套42紧固到注射器开口远端22,预定的力矩设置测试表明,与标准聚丙烯轴套(未示出)时所观察的结果相比,针头轴套42和注射器开口远端22材料之间的静摩擦产生更多的超规定量。
分离测试器利用数控马达驱动直线托架抵住一个受压换能器。
在对比测试中,所有的轴套(未示出)都以0.07Nm(牛顿米)的力矩附接至注射器开口远端22和锥部90。所有测试都是在具有相同尺寸的0.8cc注射器上进行的,例如,具有大约4mm入口直径D(参见图6)的注射器开口远端22。
不同设计因素组合下的额定力矩静态测试针头保持的结果在表1中示出。
表1示出了当常规的聚丙烯轴套以0.07Nm的力附接至具有5mm螺纹的注射器时,配合至所述注射器的所述常规聚丙烯轴套具有46.1N(牛顿)的平均分离力。
表1
不同设计因素组合下的额定力矩静态测试针头保持
在附接至具有螺距为3mm的螺纹的注射器主体的常规聚丙烯轴套中,显示出些许提高,平均分离力约为56.2N。
利用聚碳酸脂而非聚丙烯的轴套42,以及螺距为5mm的螺纹用于附接导致平均分离力为83.2N。
结合聚碳酸酯轴套42以及螺距为3mm的螺纹,但没有台阶88导致平均分离力为96N。
出乎意料地,对于所述轴套42以及螺距为3mm的螺纹,及包括死区缩小台阶88的分离力,其导致平均分离力为200N以上。
设想了其他结构也可用于以相对于常规的注射器/针头组合有效增加分离力的方式缩小死区。例如,在本发明的范围内,设想了可以通过如下方式实现缩小的死区:即,减小注射器鲁尔顶端的外径,增加轴套腔室的内径,和/或有效增加注射器顶端与轴套的接合长度的其他方式。
实施例
进行一个多中心的、双盲、随机平行控制预期对照试验,以测试针头分离率。这项试验测试了根据本发明的聚碳酸酯轴套和具有螺距为3mm的螺纹以及阶梯型腔室的注射器(试验装置)与常规的聚丙烯轴套和具有螺距为5mm的螺纹的注射器(常规装置)相比的针头分离率。每一个常规装置和试验装置的针头都是30G×1/2″针头。用于所述试验的注射材料是JuvedermTM超精度可注射凝胶(皮肤填充物)。
存在多达288个试验参与者。每个试验参与者都进行了使用或者以常规装置或者以试验装置包装的两注射器的皮肤填充物来改善他/她的两侧鼻唇褶的处理。
结果表明,在常规装置和试验装置之间的针头脱离率方面存在显著差异。据报道,试验装置没有脱离接合的报道。常规装置的针头的3%到7%在注射过程中意外脱离。
尽管上文出于示出其中本发明用于产生良好效果的方式的目的,描述了根据本发明的具体注射装置,但应理解本发明不限于此。即是说,本发明可合适地包括所述元件,由所述元件组成,或者基本上由所述元件组成。而且,此处被合适地公开示出的本发明可在缺少未在此处具体公开的任何元件的情况下被实施。相应地,本领域技术人员可联想到的任意和所有修改、变化或等同布置都应认为落在如所附权利要求所限定的本发明的范围内。
Claims (20)
1.注射装置,包括:
注射器,其具有主体以及开口远端,在该主体中设有活塞;
针头组件,其包括插管和鲁尔接头,所述鲁尔接头与注射器远端相接合,所述插管具有大于约25的规格,所述鲁尔接头包括轴套,该轴套具有支撑所述插管的远端和与所述注射器远端相配合的近端;
粘性流体,其具有的粘度在约50,000厘泊到约200,000厘泊之间,所述粘性流体被布置在所述主体内,并且被所述活塞通过所述插管注射进人体或动物体的体表位置;
阶梯型死区缩小腔室,其布置在所述轴套内,用于防止所述轴套与所述注射器远端在注射所述粘性流体的过程中分离;以及
布置在所述注射器远端的内螺纹和布置在所述轴套上的外螺纹,所述内螺纹和所述外螺纹使得能够配接,以及使得一旦操作所述活塞就能够将所述粘性流体通过所述插管喷射出,所述内螺纹的螺距足以进一步防止所述轴套与所述注射器远端在注射所述粘性流体的过程中分离。
2.根据权利要求1所述的装置,其中所述轴套由聚碳酸酯制成。
3.根据权利要求1所述的装置,其中所述内螺纹具有的螺距为约3mm。
4.根据权利要求3所述的装置,其中所述内螺纹包括双线螺丝螺纹。
5.根据权利要求4所述的装置,其中所述外螺纹包括双线螺丝螺纹。
6.根据权利要求1所述的装置,其中所述外螺纹包括单圈双线螺丝螺纹。
7.根据权利要求1所述的装置,其中所述粘性流体包括透明质酸基的皮肤填充物。
8.根据权利要求1所述的装置,其中所述粘性流体的粘度至少为约130,000厘泊。
9.根据权利要求7所述的装置,其中所述粘性流体的粘度至少为约130,000厘泊。
10.一种注射装置,包括:
注射器,其具有主体以及开口远端,在所述主体中设有活塞;
针头组件,其包括插管和鲁尔接头,所述鲁尔接头与注射器远端相接合,所述插管具有大于约25的规格,所述鲁尔接头包括轴套,该轴套具有支撑所述插管的远端和与所述注射器远端相配合的近端;
粘性流体,其具有的粘度大于约130,000厘泊,所述粘性流体被布置在所述主体内,并且被所述活塞通过所述插管注射进人体或动物体的体表位置;
轴套保持腔室,其布置在所述轴套内,用于防止所述轴套与所述注射器远端在注射所述粘性流体的过程中分离;以及
布置在所述注射器远端的内螺纹和布置在所述轴套上的外螺纹,所述内螺纹和所述外螺纹使得能够配接,以及使得一旦操作所述活塞就能够将所述粘性流体通过所述插管喷射出,所述内螺纹的螺距足以进一步防止所述轴套和注射器远端在注射所述粘性流体的过程中分离。
11.根据权利要求10所述的装置,其中所述轴套由聚碳酸酯制成。
12.根据权利要求10所述的装置,其中所述粘性流体包括透明质酸基的皮肤填充物。
13.根据权利要求10所述的装置,其中所述内螺纹具有的螺距为约3mm。
14.根据权利要求13所述的装置,其中所述内螺纹包括双线螺丝螺纹。
15.根据权利要求14所述的装置,其中所述外螺纹包括双线螺丝螺纹。
16.根据权利要求15所述的装置,其中所述粘性流体包括透明质酸基的皮肤填充物。
17.根据权利要求10所述的装置,其中所述轴套保持腔室包括阶梯型内表面。
18.一种注射装置,包括:
注射器,其具有主体以及开口远端,在该主体中设有活塞;
针头组件,其包括插管和鲁尔接头,所述鲁尔接头与注射器远端相接合,所述插管具有大于约25的规格,所述鲁尔接头包括轴套,该轴套具有支撑所述插管的远端和与所述注射器远端相配合的近端,所述轴套包括一个轴套保持腔室,该轴套保持腔室包括一个阶梯型内表面;以及
布置在所述注射器远端的内螺纹和布置在所述轴套上的外螺纹,所述内螺纹和所述外螺纹使得能够配接,以及使得一旦操作所述活塞就能够将所述粘性流体通过所述插管喷射出,其中所述内螺纹具有的螺距在约2mm到约5mm之间。
19.根据权利要求18所述的装置,其中所述内螺纹具有的螺距为约3mm。
20.根据权利要求19所述的装置,其中所述注射器包括锥形注射器锥部,以及所述轴套的所述内表面与所述锥形注射器锥部成相对应的锥形,由此在所述内表面和所述锥形注射器锥部之间提供密封。
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