CN104159527A - 包含止血糊剂的压力容器 - Google Patents

包含止血糊剂的压力容器 Download PDF

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CN104159527A
CN104159527A CN201380012440.2A CN201380012440A CN104159527A CN 104159527 A CN104159527 A CN 104159527A CN 201380012440 A CN201380012440 A CN 201380012440A CN 104159527 A CN104159527 A CN 104159527A
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梅特·克罗格·詹森
克里斯蒂安·拉森
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    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
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Abstract

本发明涉及一种适应于在压力下分配其内容的容器。本发明的容器包括通过可滑动的活塞分离的两个彼此分离的隔间。本发明的容器含有止血糊剂。

Description

包含止血糊剂的压力容器
技术领域
本发明涉及一种适应于在压力下分配其内容的容器。本发明的容器由两个分离的隔间组成,这两个分离的隔间通过可滑动的活塞彼此隔开。本发明的容器包含止血糊剂。
背景技术
在外科治疗中,使用止血剂对出血进行控制。已经知道了止血剂、补充压力、绷带和其他控制毛细管、静脉和动脉出血的传统方法。
现在,在止血控制领域,市场上存在不同的用于实施止血剂的设备。
一种这样的产品是应用于敷药器尖端的预填式注射器。该注射器在容积中包含糊剂形式的止血剂,其允许止血剂在容纳单元中与任何其他药剂(比如水、生理盐水和凝血酶)适当混合。人工混合止血剂和其他药剂后,在注射器中形成止血糊剂。
仅在已经形成这样的止血糊剂后,用户才可以将该糊剂应用于出血部位。
注射器的设计导致了需要从后面在位于容纳单元中的活塞上施加手动压力,这导致损失一些对敷药器尖端所指方向的控制,即,这使得正确瞄准出血部位更加困难。
由于在混合后形成于容纳单元中的止血糊剂的粘性,因此用户为了将止血糊剂从容纳单元排空到出血部位上,不得不对活塞端部施加相当大的力。
由于需要相对大的力,因此该产品的实施精度有限并且该设备具有有限的用户友好性。
因此,在止血控制领域中,需要一种易用设备,其从无菌容器直接对出血部位提供止血糊剂,其具有高的精度并且易于用户使用。
通常从加压容器中分配出大范围的材料。存在能够使产品保持不接触推进物的特殊容器。一般来说,这些容器有两种类型,“折叠袋”型和“活塞”型。“折叠袋”型包括一种折叠袋装置,将产品保持在与具有出口阀的容器颈部固定的柔性袋中。将推进物保持在袋子和容器壁之间。在压力下,袋子折叠并且使产品从出口阀突出。在高压下通过阀实现袋子的填充,其引起糊剂产品中的相分离。因此,经过阀的产品的填充使其在完成填充后,在阀的开口处保留有剩余的糊剂。该剩余的糊剂将起到糊剂塞子的作用,在使用该设备之前,必须将其清除。并且,阀的开口是受限的,其使填充、特别是排空会很困难。
“活塞”型容器通过内部活塞分成两个腔体,产品和推进物凭借该活塞彼此分离地保持。在推进物的压力下,活塞迫使产品从容器经过阀。
“活塞”型容器通常用于液体、流体、糊剂和塑料形式的产品,比如食品(蛋黄酱、奶油等)、化妆品(牙膏、剃须膏等)、药品(药膏、杀鼠剂等)和化学产品(密封剂、粘合剂等)。
发明内容
本发明涉及一种用于在压力下从容器分配止血糊剂的设备,该设备具有内部,该内部包括彼此分离的产品隔间和推进物隔间,该设备还具有分离产品隔间与推进物隔间的可滑动的活塞。
该设备提供止血糊剂,可以以高精度且使用极小的力支配该止血糊剂。优选地,止血糊剂可以随时使用。在本文中,随时使用的意思是其可以直接从加压容器应用至对象。这不排除在将止血糊剂排出加压容器后,将其他成分混合加入止血糊剂中的可能性。
具体实施方式
在止血控制领域,有益的是能够提供一种具有高精度并且用户使用少量力的直接从加压容器到出血部位的止血糊剂。使用止血糊剂,需要将糊剂与推进物分离存储,旨在将糊剂保持在压力下。为此,通过能够以抵靠容器主体内表面密封接触而滑动的活塞将糊剂与推进物分离保存。
为了获得活塞的所需优势,这样的系统需要其贯穿设备的生命周期,即,从首次使用到最后一次使用,通过推进物挤压的压力必须大于产品的蒸汽压力。
本发明涉及一种用于在压力下从容器分配止血糊剂的设备。
通过这种方式,提供无菌的和易支配的止血糊剂。外科医生表示现在的注射器型敷药器需要施加相当大的力,这损失了精度。本发明克服了这个问题,其通过使用推进物作为驱动力,使得对止血糊剂的支配更容易。此外,本发明的设备设计为能够指向各个方向,同时仍然可能完全清空容器。这在外科治疗过程中出血部位可能在难以到达的位置处是非常重要的。如上所述,以前的产品为了应用于出血部位通常需要相当大的手动力量,精确应用止血剂是困难的并且需要外科医生的一些力气。
本发明的设备包括具有内部的容器,该内部包括彼此分离的产品隔间和推进物隔间,所述容器具有第一末端,该第一末端具有从产品隔间延伸的止血糊剂出口,所述出口是可打开并且可闭合的。阀定位为与产品隔间的第一末端连通。该阀可以定位为与止血糊剂出口连接,以允许止血糊剂经过止血糊剂出口流到设备外部。可滑动的活塞使产品隔间与推进物隔间分离。
该活塞可包括主活塞,其具有接合主壁的裙部,以及辅助活塞,其具有接合辅助壁的裙部,插入的可变形密封剂材料位于所述主活塞和辅助活塞之间。
在压力下,所述可变形材料可以在主活塞和辅助活塞之间被压缩,其抵靠容器壁推进以形成密封。为了确保这种功能,主活塞优选地与所包含的壁摩擦接合并且辅助活塞优选地处于松动配合,从而促进所插入的可变形密封剂材料的压缩。主活塞和辅助活塞的这种设置使其可以在推进物腔体和产品腔体之间提供有效密封,确保推进物在任何时候都不与产品混合。
可变形密封剂材料可以与其在使用中将接触到的材料化学地兼容的任何液体或半固态材料。如海藻酸材料中的水凝胶这样的水性材料是适合的,许多有机矿物油脂、润滑脂和蜡也是适合的。在一个实施例中,密封剂材料可以选自由乙二醇、二甘醇、丁二醇、戊烯醇、丙三醇、甘油聚合物、甘油、聚乙烯醇、硅胶、丙烯酸树脂组成的组。
在一个实施例中,可变形密封剂材料是凝胶。在一个更优选的实施例中,可变形密封剂是水凝胶。
用于本发明的阀优选地设置为允许止血糊剂容易流经止血糊剂出口并且允许糊剂经过阀被分配排出。由于止血糊剂是粘性的糊剂,因此阀可以设有优化的流体通道,例如该流体通道具有大的入口和/或出口的开口、光滑表面和/或糊剂可以在不受弯曲处、突出物等限制的情况下流经的通道。
在一些有利实施例中,阀还装配有可替换的、可弯曲的和/或可切割的已知类型的长尖端。例如,将这种尖端与止血糊剂敷药器结合使用。
为了允许在难以到达的位置支配止血糊剂,可以选择可替换的尖端,以允许具有特定粘度的流体通过和/或在特定流动率下支配流体。
如果提供可切割的长尖端,则该尖端可以鉴于支配环境被切割成需要的长度,例如流体(止血糊剂)的粘度、支配区域等。如果长尖端至少部分是锥形的,则该尖端可以被切割以提供特定直径的尖端出口。
可选择地,提供可弯曲的尖端,其在弯曲后保持其形状,并且优选地,弯曲时不扭结。该可弯曲的尖端在各个方向可以是可弯曲的。
因此,用户可以为了支配特定流体和/或为了在难以到达的区域支配流体而优化尖端的形状。例如,可替换的尖端可以弯曲以具有最佳曲率,并且可以由用户切割为具有需要的长度。
在一个实施例中,尖端的长度在5-20cm之间,例如长度为10-20cm、15-20cm。
在一个实施例中,尖端是不可弯曲的。
当使用长尖端时,例如上面提到的可弯曲尖端,加强了对控制保持和移动的要求。这是由于用户的手的任何移动会在远处的尖端增强。
优选地,该设备包括与阀门构件连接的可移动的致动器,以便致动器的驱动运动将阀门构件驱动到打开位置。例如,致动器可以是这样的形式:致动器的手柄部件沿容器侧面距离容器一定的距离和角度定位,该距离和角度使用户容易达到并下压,优选地,手的位置变化微小。
此外,为了驱动阀并且支配止血糊剂,致动器可以优选地设置为需要用户极小的力。例如,这可以通过具有铰接的杠杆臂的致动器设置来实现,该杠杆臂将用户施加的力传递到可移动的阀门构件。当需要少量的力驱动阀时,用户具有更可能稳定的手并且不太可能对设备造成故意的移动,这确保了对止血糊剂的可靠而优化的支配。
在一个实施例中,在室温下,推进物腔体中的压力的范围是100-500kPa,更优选地,范围是200-500kPa,例如,300-500kPa,更优选地,400-500kPa。在另一个实施例中,在室温下,推进物腔体中的压力的范围是100-400kPa,例如,100-300kPa,更优选地,100-200kPa。
推进物可以选自由氮气、氧气、压缩空气、丁烷、丙烷、含氯氟烃、氟碳和二甲醚组成的组。在一个优选实施例中,推进物是氮气、氧气或压缩空气。
示例1对填充的优选方法和设备的装配进行了简单描述。
在室温下,本发明的止血糊剂的粘度的范围是700-4,000Pa·s,比如在1,000-4,000Pa·s之间,例如1,200-4,000Pa·s,比如在1,400-4,000Pa·s之间,例如1,600-4,000Pa·s,比如在1,800-4,000Pa·s之间,例如2,000-4,000Pa·s,比如在2,200-4,000Pa·s之间,例如2,400-4,000Pa·s,比如在2,600-4,000Pa·s之间,例如2,800-4,000Pa·s,比如在3,000-4,000Pa·s之间,例如3,200-4,000Pa·s,比如在3,400-4,000Pa·s之间,例如3,600-4,000Pa·s,比如在3,800-4000Pa·s之间。
在本发明的另一个实施例中,本发明的止血糊剂的粘度在700-4,000Pa·s的范围内,例如700-3,800Pa·s,比如在700-3,600Pa·s的范围内,例如700-3,400Pa·s,比如在700-3,200Pa·s的范围内,例如700-3,000Pa·s,比如在700-2,800Pa·s的范围内,例如700-2,600Pa·s,比如在700-2,400Pa·s的范围内,例如700-2,200Pa·s,比如在700-2,000Pa·s的范围内,例如700-1,800Pa·s,比如在700-1,600Pa·s的范围内,例如700-1,400Pa·s,比如在700-1,200Pa·s的范围内,例如700-1,000Pa·s,比如在700-900Pa·s的范围内,例如700-800Pa·s。
本发明的止血糊剂可以包含10-25%体积比(v/v)的明胶或胶原蛋白和适当的液体。适当的液体可以选自由无菌水、无菌生理盐水和无菌磷酸(PBS)缓冲液组成的组。止血糊剂可以与另外的活性成分相结合。可以对止血糊剂添加适量的另外的活性成分。这种另外的活性成分可以选自由杀菌剂、防腐剂、抗菌剂、凝血因子、纤维蛋白溶解抑制剂、表面活性剂、促进愈合的生长因子、辅助凝固的钙离子、肾上腺素或其他能够收缩血管的物质组成的组。
凝血因子的具体例子包括从由凝血酶、纤维蛋白原、抑肽酶、纤连蛋白、因子XIII、因子VII、因子VIII以及它们的组合组成的组选择的凝血因子。这样的化合物可以来源于任何哺乳动物,比如来源于猪或人类,或者可以通过技术人员熟知的方法通过重组方式获得。应当理解的是,明胶和胶原蛋白不能被认为是凝血因子。
纤维蛋白溶解抑制剂可以选自由氨甲环酸、H-氨基己酸(H-aminocaproicacid)、抑肽酶、胃酶抑素、亮抑蛋白酶肽、抗蛋白酶、糜蛋白酶抑制素、加贝酯及其混合物组成的组。如果存在纤维蛋白溶解抑制剂,则优选为氨甲环酸。
抗菌剂可以选自杀菌剂或抑菌剂,比如抗生素和磺胺类药、抗病毒化合物、抗真菌剂和抗感染药。
表面活性剂可以选自由阴离子表面活性剂、阳离子表面活性剂、非离子表面活性剂和表面活性生物调节剂组成的组。
然而,在本发明的一个优选实施例中,组合物不包含另一种活性剂,即,所述组合物不包含杀菌剂、凝血因子、纤维蛋白溶解抑制剂、表面活性剂、抗菌剂、防腐剂、生长因子、钙离子、肾上腺素和/或其他能够收缩血管的物质。
止血糊剂的全部成分应当能够经受辐射杀菌并且仍旧保持活性。
在本发明的设备中,在室温下,优选地,止血糊剂最少具有两年的保质期。
在使用中,将阀打开,释放内部压力,推进物腔体中的推进物扩张,从而迫使辅助活塞进入更加紧密地接触抵靠容器壁向外推进的密封剂。主活塞前进并使产品从阀突出。
优选地,主活塞和辅助活塞最好由塑料材料制成,该塑料材料选自由聚乙烯(HDPE)、聚苯乙烯、丙烯腈-丁二烯-苯乙烯(ABS)、聚铣胺(PA)、聚丙烯和聚氯乙烯(PVC)组成的组。优选地,主活塞和辅助活塞由HDPE制成。
优选地,该容器由内侧镀有涂层的铝制成。该涂层可以选自由食品及药物管理局(FDA)批准的涂层组成的组,例如但不限于,PPG2497-303/A(PPG Industries Lackfabrik公司)、PPG2956-401/A(PPG IndustriesLackfabrik公司)和J3121(Valspar)。
设备的阀可以安装有适合的致动器。为了排空设备,需要用户施加在致动器上的压力可以根据致动器的不同类型而改变。
优选地,该设备及其全部组件由可以经受伽玛辐射和β辐射灭菌的材料制成。在一个实施例中,所述灭菌在10-50kGy下进行,更优选地,在10-40kGy,例如10-30kGy,更优选地,10-20kGy。在另一个实施例中,灭菌在10-50kGy下进行,例如20-50kGy,更优选地,30-50kGy,例如40-50kGy。在一个优选实施例中,灭菌在25-30kGy下进行。
优选地,本发明的设备完全不透气和不透光。通过辐射对设备灭菌后,存在于产品腔体中的止血糊剂被灭菌直到使用时都保持这样。
下面,参照附图进一步详细描述本发明。但是,所有附图是示例性的并且不能被认为是限制本发明。
附图说明
图1示出了本发明设备的整体设计,
图2示出了活塞的优选实施例,以及
图3示出了用于本发明的致动器的实施例。
参照图1和图2,该设备包括拉长的圆柱形容器1(其可以是挤压的或接缝的罐子)具有顶部2和内弯的圆顶基底3,顶部具有颈部4并且其中安装有带瓣的出口挤压阀5。
在容器1中,从顶部到底部连续定位主活塞6、辅助活塞7和薄膜隔离物8。在活塞6和7之间定位有大量可变形的密封剂材料9。这些部件将容器的内部容积分为用于待分配的止血糊剂的腔体10和用于推进物的腔体11。薄膜8的存在是选择性的,但是,当存在时,其与基底3形成推进物隔间12。基底3通常具有用于在填充过程中引导推进物的中心孔,填充后用塞子13闭合该中心孔。
主活塞6顶部通常被成形为符合容器顶部的内部结构和阀5的内部部件,以便使得通过活塞排出产品的数量最大化。
容器的基底3是圆顶的并且通常具有用于在填充过程中引导推进物的中心孔,该中心孔在填充后用塞子13闭合。因此,用于填充推进物的所述孔可以打开和闭合。
图3示出了用于本发明的可移动致动器4的实施例。该致动器包括杠杆臂15,其通过铰链17与设备16的止血糊剂出口连接,以及杠杆手柄18,其从杠杆臂15以大约90度角延伸。在所示结构中,杠杆手柄17通过箭头F表示的力朝容器1下压,从而打开阀,以允许糊剂从容器1内侧经过,穿过阀并且穿出尖端19。该力通过用户(图中未示出)的抓握来提供。
当用户释放该力时,杠杆臂15和手柄18将移向阀关闭的放松状态。杠杆手柄18向放松位置的移动由箭头R表示。
当用户下压杠杆手柄18时,即,当用户施加力F以打开阀时,杠杆手柄被带到平行于或接近平行于容器纵向的位置。当放松该力时,手柄沿R方向移回至容器壁。因此,当关闭阀时,杠杆手柄相对地接近容器壁并且定位在能够使用户容易地从使用全部手指抓握容器周围改变为使用一个或多个手指抓握杠杆手柄周围的角度,以便施加力F以驱动(即,打开)阀,并且支配止血糊剂直到释放力F。图3中所示的尖端19朝向尖端的远端20略微成锥形。
示例
示例1
止血糊剂的准备和设备的填充
交联明胶粉与液体混合,以致粉末完全变湿。将糊剂填充到本发明的设备中,通过打开的容器的顶部进入产品隔间。以这种方式,可以将产品填充到产品隔间中,而不使用阀并且无需在压力下。通过将阀体连接到容器,闭合容器。阀与容器通过阀体的压接固定密封。一旦阀密封容器,推进物就在压力下经过推进物隔间的开口被填充到推进物隔间中。然后用活塞(例如橡胶塞)密封推进物隔间。

Claims (27)

1.一种用于在压力下分配止血糊剂的设备,该设备包括:
a.具有内部的容器,所述内部包括彼此分离的产品隔间和推进物隔间,所述容器具有带有从产品隔间延伸的止血糊剂出口的第一末端,所述出口是可打开的并且是可闭合的;
b.与产品隔间的第一末端连通的阀;
c.包含在产品隔间中的止血糊剂;
d.提供在推进物隔间中的推进物;
e.使产品隔间与推进物隔间分离的可滑动的活塞。
2.根据权利要求1所述的设备,其中,所述活塞包括具有接合主壁的裙部的主活塞、具有接合辅助壁的裙部的辅助活塞和在所述主活塞和辅助活塞之间的插入的可变形密封剂材料。
3.根据权利要求2所述的设备,其中,在压力下,所述可变形材料在活塞之间被压缩,并且抵靠容器壁推进,以形成密封。
4.根据权利要求2-3中任一项权利要求所述的设备,其中,主活塞与壁摩擦接合,辅助活塞松动配合,从而促进插入的可变形密封剂材料的压缩。
5.根据权利要求2-4中任一项权利要求所述的设备,其中,可变形密封剂材料是凝胶。
6.根据权利要求2-5中任一项权利要求所述的设备,其中,可变形密封剂材料是水凝胶。
7.根据前述任一项权利要求所述的设备,其中,推进物选自由氮气、氧气、压缩空气、丁烷、丙烷、含氯氟烃、氟碳和二甲醚组成的组。
8.根据前述任一项权利要求所述的设备,其中,所述推进物腔体还包括推进物入口,所述入口是可打开的并且是可闭合的。
9.根据前述任一项权利要求所述的设备,其中,在室温下,推进物隔间中的压力是100-500kPa。
10.根据前述任一项权利要求所述的设备,其中,止血糊剂是明胶糊剂或胶原蛋白糊剂。
11.根据权利要求10所述的设备,其中,止血糊剂是明胶糊剂,所述明胶糊剂包含10-25%v/v的明胶、适合的液体以及选择性地一种或多种防腐剂。
12.根据权利要求10所述的设备,其中,止血糊剂是胶原蛋白糊剂,所述胶原蛋白糊剂包含10-25%v/v的胶原蛋白、适合的液体以及选择性地一种或多种防腐剂。
13.根据前述任一项权利要求所述的设备,其中,在室温下,止血糊剂的粘度范围是500-6,000Pa·s。
14.根据前述任一项权利要求所述的设备,其中,阀包括可移动的阀门构件,所述阀门构件配置为从闭合位置移动到打开位置,以使止血糊剂能够流经设备的止血糊剂出口。
15.根据权利要求14所述的设备,其中,阀由塑料材料制成,所述塑料材料选自由聚乙烯(HDPE)、聚苯乙烯、丙烯腈-丁二烯-苯乙烯(ABS)、聚铣胺(PA)、聚丙烯和聚氯乙烯(PVC)组成的组。
16.根据前述任一项权利要求所述的设备,还包括与阀门构件连接的可移动的致动器,以便致动器的驱动运动将阀门构件驱动到打开位置。
17.根据前述任一项权利要求所述的设备,其中,所述阀还包括使阀门构件向闭合位置偏置的偏置构件。
18.根据前述任一项权利要求所述的设备,其中,所述阀还包括当阀门构件在闭合位置时与阀门构件配合以防止止血糊剂从阀流出的密封件。
19.根据前述任一项权利要求所述的设备,其中,所述容器由金属或塑料制成。
20.根据权利要求19所述的设备,其中,所述容器由铝制成。
21.根据前述任一项权利要求所述的设备,其中,所述容器涂覆有FDA批准的涂层,所述涂层选自由PPG2497-303/A、PPG2956-401/A和J3121组成的组。
22.根据前述任一项权利要求所述的设备,其中,所述容器的产品隔间具有5-250ml范围的体积。
23.根据前述任一项权利要求所述的设备,其中,所述容器的推进物隔间具有5-250ml范围的体积。
24.一种对出血部位应用止血糊剂的方法,该方法包括:
a.提供前述任一权利要求所述的设备,
b.将可弯曲的或不可弯曲的和/或可切割的尖端连接到设备,
c.驱动阀,以从设备分配止血糊剂,以及
d.将被分配的止血糊剂引导到出血部位。
25.一种制造前述任一权利要求所述的设备的方法,该方法包括:
a.提供前述任一权利要求所述的设备,
b.提供止血糊剂,
c.将止血糊剂经过打开的容器的顶部填充到产品隔间中,
d.将阀连接到容器的开口端,
e.通过阀体围绕容器顶部的颈部的压接,使阀与容器固定密封,
f.在压力下,用适合的推进物经过推进物隔间的开口填充推进物隔间,
g.通过将塞子插入推进物隔间的开口,密封推进物隔间。
26.根据权利要求25所述的方法,其中,使用辐射对设备杀菌,优选地,其中,在杀菌前,对设备填充止血糊剂和推进物。
27.根据权利要求26所述的方法,其中,杀菌是伽玛辐射或β辐射。
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