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CN114712618A - A dual-chamber syringe and a charging method - Google Patents

A dual-chamber syringe and a charging method Download PDF

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Publication number
CN114712618A
CN114712618A CN202110003783.9A CN202110003783A CN114712618A CN 114712618 A CN114712618 A CN 114712618A CN 202110003783 A CN202110003783 A CN 202110003783A CN 114712618 A CN114712618 A CN 114712618A
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China
Prior art keywords
barrel
syringe
plug
injection
chamber barrel
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Inventor
高静
郑爱萍
李如华
王丹
高翔
邸金威
张慧
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Academy of Military Medical Sciences AMMS of PLA
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Academy of Military Medical Sciences AMMS of PLA
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Priority to CN202110003783.9A priority Critical patent/CN114712618A/en
Publication of CN114712618A publication Critical patent/CN114712618A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/1782Devices aiding filling of syringes in situ
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/19Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3129Syringe barrels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention belongs to the field of medicines and medical instruments, and relates to a double-chamber syringe and a charging method. Specifically, include injection head (21), syringe (10), plug (16) and push rod (32), wherein: the injection cylinder (10) comprises a front chamber cylinder (11) and a rear chamber cylinder (13), wherein the front chamber cylinder (11) is detachable. The invention reduces the preparation process flow of the solid powder after the freeze-drying of the medicine, realizes that the solid medicine and the injection are pre-filled in the same injector, can realize the one-time completion of the medicine dispensing and the injection, has simple and convenient operation, avoids the pollution of the medicine packaging and the medicine dispensing process, and obviously reduces the preparation and use cost.

Description

一种双室注射器以及一种装料方法A dual-chamber syringe and a charging method

技术领域technical field

本发明属于医药和医疗器械领域,涉及一种双室注射器以及一种装料方法。具体地,本发明涉及一种预装冻干药物的双室注射器。本发明还涉及所述双室注射器的装料方法。The invention belongs to the field of medicine and medical equipment, and relates to a double-chamber syringe and a charging method. Specifically, the present invention relates to a dual-chamber syringe prefilled with lyophilized medicine. The present invention also relates to a charging method for the dual-chamber syringe.

背景技术Background technique

对于化学状态不稳定、热敏的粉针剂药物,通常采用西林瓶作为容器盛装药物,冻干后轧盖封装,可以实现较长时间的保存。使用时,通常由医院护士按比例用注射液溶解药物,完成注射药物的配置。这种方法需要专业、熟练的操作人员(如护士)和洁净的环境,且配置过程需要一定的时间,不适合院外患者自用,或突发紧急情况下的使用。For powder injection drugs that are chemically unstable and heat-sensitive, vials are usually used as containers to hold the drugs, and they can be sealed by crimping after lyophilization, which can be stored for a long time. When in use, the hospital nurses usually dissolve the medicine with the injection in proportion to complete the configuration of the injection medicine. This method requires professional and skilled operators (such as nurses) and a clean environment, and the configuration process takes a certain amount of time, which is not suitable for self-use by patients outside the hospital or in emergency situations.

目前,市场上一些固液双室型注射器能够解决上述问题,可在使用时将注射液与药物粉末快速混合,实现配药、注射一次性完成。此类注射器尽管操作过程简单,但是在药物生产制备以及往注射器分装的过程较为复杂,环境要求较高,质量控制比较困难。该类型注射器常用的药物分装的方式是先预充填注射液,然后高温灭菌,最后人工充填药物粉末。这种方法由于高温灭菌,胶塞等密封件会残存一些水分,容易渗透到药物粉末中,影响药物的稳定性;而且人工精确定量充填的操作较为复杂,注射器的药物分装可操作性差。此外,药物粉末的制备工艺较为复杂,在药物冻干的基础上还需要药物粉碎收集,一方面需要严格的洁净环境,保证药物制备过程的无菌;二是药物在粉碎、定量分装过程会需长时间暴露在空气中,需要对环境进行干燥,避免药物暴露在潮湿的空气中,影响药物稳定性。因此,现有的固液双室型注射器虽然操作简单,但在药物充填时过程复杂,可操作性差。At present, some solid-liquid dual-chamber syringes on the market can solve the above problems, and can quickly mix the injection liquid and the drug powder during use, so that the dispensing and injection can be completed at one time. Although the operation process of this type of syringe is simple, the process of drug production and preparation and the process of sub-packaging into the syringe is relatively complicated, the environmental requirements are relatively high, and the quality control is relatively difficult. The commonly used method of drug distribution in this type of syringe is to pre-fill the injection solution, then sterilize it at high temperature, and finally manually fill the drug powder. Due to high temperature sterilization in this method, some water will remain in the seals such as rubber stoppers, which will easily penetrate into the drug powder and affect the stability of the drug. Moreover, the operation of manual accurate quantitative filling is relatively complicated, and the operability of the syringe for drug dispensing is poor. In addition, the preparation process of drug powder is relatively complicated. On the basis of drug freeze-drying, drugs need to be pulverized and collected. On the one hand, a strict clean environment is required to ensure the sterility of the drug preparation process; It needs to be exposed to the air for a long time, and the environment needs to be dried to avoid exposure of the drug to the humid air, which will affect the stability of the drug. Therefore, although the existing solid-liquid dual-chamber syringe is simple to operate, the process of drug filling is complicated and the operability is poor.

目前,需要开发新的双室注射器。Currently, new dual-chamber syringes need to be developed.

发明内容SUMMARY OF THE INVENTION

本发明人经过深入的研究和创造性的劳动,制得了一种前后室筒状结构的预装药物双室注射器,其中前室筒是药物的容器,与液体药物一起冻干,冻干完成后直接组装成注射器;后室筒装载定量的注射用溶媒。在不使用时,前室筒和后室筒相互隔断,前室的药物保持干燥的固体状;使用时,前室筒和后室筒连通,注射液进入前室筒与固体药物混合。由此提供了下述发明:Through in-depth research and creative work, the inventor has produced a pre-filled drug dual-chamber syringe with a front and rear chamber barrel structure, wherein the front chamber barrel is a container for drugs, freeze-dried together with liquid drugs, and directly after the freeze-drying is completed. Assembled into a syringe; the rear chamber barrel is loaded with a dose of vehicle for injection. When not in use, the front chamber barrel and the rear chamber barrel are separated from each other, and the medicine in the front chamber remains dry and solid; when in use, the front chamber barrel and the rear chamber barrel are connected, and the injection enters the front chamber barrel to mix with the solid drug. Thereby the following invention is provided:

本发明的一个方面涉及一种注射器,包括注射头(21)、注射筒(10)、推塞(16)和推杆(32),其中:One aspect of the present invention relates to a syringe, comprising an injection head (21), a syringe barrel (10), a push plug (16) and a push rod (32), wherein:

所述注射筒(10)包括前室筒(11)和后室筒(13),其中,前室筒(11)是可拆装的;The injection barrel (10) includes a front chamber barrel (11) and a rear chamber barrel (13), wherein the front chamber barrel (11) is detachable;

优选地,前室筒(11)能够用于盛装液体并用于冻干。Preferably, the antechamber (11) can be used to contain liquids and for lyophilization.

在本发明的一些实施方式中,所述的注射器,其中,前室筒(11)内有胶塞(14)。In some embodiments of the present invention, in the syringe, there is a rubber stopper (14) in the front chamber barrel (11).

在本发明的一些实施方式中,所述的注射器,其中,后室筒(13)内有靠近后室筒(13)近端(13a)的隔断塞(15),用于前室筒(11)和后室筒(13)的隔断;以及位于后室筒(13)远端(13b)的推塞(16)。In some embodiments of the present invention, the syringe, wherein the rear chamber barrel (13) has a blocking plug (15) close to the proximal end (13a) of the rear chamber barrel (13) for use in the front chamber barrel (11). ) and the partition of the rear chamber barrel (13); and a push plug (16) located at the distal end (13b) of the rear chamber barrel (13).

在本发明的一些实施方式中,所述的注射器,其中,胶塞(14)到前室筒(11)近端(11a)的垂直距离表示为L,L为隔断塞15厚度的1-3倍;In some embodiments of the present invention, in the syringe, the vertical distance from the rubber stopper (14) to the proximal end (11a) of the anterior chamber barrel (11) is represented as L, where L is 1-3 of the thickness of the blocking plug 15 times;

优选地,L为隔断塞15厚度的1.2-1.8倍(例如1.2倍、1.3倍、1.4倍、1.5倍、1.6倍、1.7倍或1.8倍);Preferably, L is 1.2-1.8 times the thickness of the partition plug 15 (eg 1.2 times, 1.3 times, 1.4 times, 1.5 times, 1.6 times, 1.7 times or 1.8 times);

更优选地,L为隔断塞15厚度的1.4-1.6倍。More preferably, L is 1.4-1.6 times the thickness of the blocking plug 15 .

在本发明的一些实施方式中,所述的注射器,其中,所述前室筒(11)和后室筒(13)的通径相同,并且均为独立管体。In some embodiments of the present invention, in the syringe, the front chamber barrel (11) and the rear chamber barrel (13) have the same diameter and are both independent tubes.

在本发明的一些实施方式中,所述的注射器,其中,前室筒(11)的远端(11b)和后室筒(13)的近端(13a)通过连接筒(12)连接,连接筒(12)的通径与前室筒(11)和后室筒(13)的通径相同。In some embodiments of the present invention, in the syringe, the distal end (11b) of the front chamber barrel (11) and the proximal end (13a) of the rear chamber barrel (13) are connected through a connecting barrel (12), and the connection is The diameter of the barrel (12) is the same as that of the front chamber barrel (11) and the rear chamber barrel (13).

在本发明的一些实施方式中,所述的注射器,其中,连接筒(12)中间部位的长度表示为H,H为隔断塞15厚度的1.2-1.8倍(例如1.2倍、1.3倍、1.4倍、1.5倍、1.6倍、1.7倍或1.8倍),优选为1.4-1.6倍,更优选为1.5倍;In some embodiments of the present invention, in the syringe, the length of the middle part of the connecting barrel (12) is represented as H, and H is 1.2-1.8 times (eg 1.2 times, 1.3 times, 1.4 times the thickness of the blocking plug 15) , 1.5 times, 1.6 times, 1.7 times or 1.8 times), preferably 1.4-1.6 times, more preferably 1.5 times;

优选地,H小于隔断塞15和推塞16的厚度之和。Preferably, H is less than the sum of the thicknesses of the blocking plug 15 and the push plug 16 .

在本发明的一些实施方式中,所述的注射器,其中,连接筒(12)中间部位设有一个或多个连通槽(12a);联通槽(12a)用于连通前室筒(11)和后室筒(13),当隔断塞(15)滑动到连接筒(12)中间部位时,前室筒(11)和后室筒(13)联通;In some embodiments of the present invention, in the syringe, one or more communication grooves (12a) are provided in the middle part of the connecting cylinder (12); the communication grooves (12a) are used to communicate with the front chamber cylinder (11) and the the rear chamber barrel (13), when the blocking plug (15) slides to the middle part of the connecting barrel (12), the front chamber barrel (11) and the rear chamber barrel (13) are communicated;

优选地,联通槽(12a)的数量为1-6个,更优选2、3或4个。Preferably, the number of communication grooves (12a) is 1-6, more preferably 2, 3 or 4.

在本发明的一些实施方式中,所述的注射器,其中,连接筒(12)中间部位设有一个或多个阻尼肋(12b);In some embodiments of the present invention, in the syringe, one or more damping ribs (12b) are provided in the middle part of the connecting cylinder (12);

优选地,阻尼肋(12b)的数量为1-6条,更优选2、3或4条。Preferably, the number of damping ribs (12b) is 1-6, more preferably 2, 3 or 4.

在本发明的一些实施方式中,所述的注射器,其中,隔断塞(15)到后室筒(13)近端(13a)的垂直距离表示为M,M为隔断塞(15)厚度的0.5到1倍。In some embodiments of the present invention, in the syringe, the vertical distance from the blocking plug (15) to the proximal end (13a) of the rear chamber barrel (13) is represented as M, where M is 0.5 of the thickness of the blocking plug (15). to 1 times.

在本发明的一些实施方式中,所述的注射器,其中,注射筒(10)的近端(10a)与注射头(21)连接。In some embodiments of the present invention, the syringe, wherein the proximal end (10a) of the syringe barrel (10) is connected with the injection head (21).

在本发明的一些实施方式中,所述的注射器,其中,In some embodiments of the present invention, the syringe, wherein,

注射头(21)内腔的内径D与比胶塞(14)外径大5%至10%;和The inner diameter D of the inner cavity of the injection head (21) is 5% to 10% larger than the outer diameter of the rubber stopper (14); and

注射头(21)的内腔高度N大于胶塞(14)的厚度,优选N为胶塞(14)厚度的1.2-1.4倍。The inner cavity height N of the injection head (21) is greater than the thickness of the rubber stopper (14), preferably N is 1.2-1.4 times the thickness of the rubber stopper (14).

在本发明的一些实施方式中,所述的注射器,其中,In some embodiments of the present invention, the syringe, wherein,

注射头(21)内腔的四周和底部有凹槽(21a),凹槽(21a)连通针嘴(21c),There are grooves (21a) around and at the bottom of the inner cavity of the injection head (21), and the grooves (21a) communicate with the needle nozzle (21c),

优选地,凹槽(21a)为1-6条,优选为2、3或4条;Preferably, there are 1-6 grooves (21a), preferably 2, 3 or 4;

在本发明的一些实施方式中,所述的注射器,其中,注射头(21)内腔的四周有至少2条肋条(21b),所述肋条等间距圆周排列,并且全部肋条围起来的内圆直径等于胶塞(14)直径;In some embodiments of the present invention, in the syringe, there are at least two ribs (21b) around the inner cavity of the injection head (21), the ribs are circumferentially arranged at equal intervals, and the inner circle surrounded by all the ribs The diameter is equal to the diameter of the rubber stopper (14);

优选地,肋条为3-12条,优选为3-6条。Preferably, the number of ribs is 3-12, preferably 3-6.

在本发明的一些实施方式中,所述的注射器,其中,注射头(21)与注射针座(22)相连;注射针座(22)固定了注射针(23);In some embodiments of the present invention, in the syringe, the injection head (21) is connected with the injection needle seat (22); the injection needle seat (22) fixes the injection needle (23);

优选地,注射头(21)与注射针座(22)通过螺纹的形式连接;Preferably, the injection head (21) and the injection needle seat (22) are connected in the form of threads;

优选地,注射针座(22)还连接注射针套(24)。Preferably, the injection needle seat (22) is also connected to the injection needle cover (24).

在本发明的一些实施方式中,所述的注射器,其中,后室筒(13)内的推塞(16)连接推杆(32);In some embodiments of the present invention, in the syringe, wherein the push plug (16) in the rear chamber barrel (13) is connected to the push rod (32);

优选地,推杆(32)与推塞(16)通过螺纹的形式连接;Preferably, the push rod (32) and the push plug (16) are connected in the form of threads;

优选地,注射筒(10)的远端(10b)连接有指柄(31);Preferably, the distal end (10b) of the syringe (10) is connected with a finger handle (31);

优选地,指柄(31和推杆(32)构成注射器单手注射操作的结构;Preferably, the finger handle (31 and the push rod (32) constitute the structure of the syringe for one-handed injection operation;

优选地,在靠近推塞(16)的推杆(32)一侧有一吸水环(33),推杆(32)穿过指柄(31)与吸水环(33)、推塞(16)相连;Preferably, there is a water suction ring (33) on the side of the push rod (32) close to the push plug (16), and the push rod (32) is connected to the water suction ring (33) and the push plug (16) through the finger handle (31). ;

优选地,指柄(31)中间开口直径小于吸水环(33)和推塞(16)的直径。Preferably, the diameter of the middle opening of the finger handle (31) is smaller than the diameters of the water suction ring (33) and the push plug (16).

在本发明的一些实施方式中,所述的注射器,其中,前室筒(11)和胶塞(14)构成的容器(101)可用于盛装液体药物并冻干;In some embodiments of the present invention, in the syringe, the container (101) formed by the front chamber barrel (11) and the rubber stopper (14) can be used to hold liquid medicines and freeze-dried;

优选地,冻干后得到的固体药物可直接用于注射器的封装。Preferably, the solid drug obtained after lyophilization can be directly used for packaging of the syringe.

在本发明的一些实施方式中,所述的注射器,其中,后室筒(13)和隔断塞(15)和推塞(16)构成的容器(102),可用于预充填注射液。In some embodiments of the present invention, the syringe, wherein the back chamber barrel (13) and the container (102) formed by the blocking plug (15) and the push plug (16) can be used for pre-filling the injection solution.

本发明的另一方面涉及本发明中任一项所述的注射器的装料方法,包括如下步骤:Another aspect of the present invention relates to a method for charging a syringe according to any one of the present invention, comprising the steps of:

①将灭菌后的前室筒(11)或者灭菌后的前室筒(11)和胶塞(14)构成的容器(101)盛装固体药物或液体药物;优选地,液体药物在无菌洁净环境下冻干,冻干后得到固体药物;① The sterilized front chamber barrel (11) or the container (101) formed by the sterilized front chamber barrel (11) and the rubber stopper (14) is filled with solid medicine or liquid medicine; Freeze-dried in a clean environment to obtain solid drug after freeze-drying;

②将灭菌后的后室筒(13)和推塞(16)、可选的指柄(31)、推杆(32)以及可选的吸水环(33)进行组装,形成容器(102);② Assemble the sterilized rear chamber cylinder (13), push plug (16), optional finger handle (31), push rod (32) and optional water suction ring (33) to form a container (102) ;

③在无菌洁净环境下,向容器(102)内分装注射液,移液后装入隔断塞(15)。③ In a sterile and clean environment, sub-fill the injection solution into the container (102), and then install the partition plug (15) after pipetting.

在本发明的一些实施方式中,所述注射器为医用注射器。In some embodiments of the invention, the syringe is a medical syringe.

在本发明的一些实施方式中,前室筒中的药物为固体药物或液体药物,优选为适用于冻干的液体药物或者冻干后得到的固体药物例如冻干制剂,优选为冻干粉针剂。In some embodiments of the present invention, the drug in the front chamber is a solid drug or a liquid drug, preferably a liquid drug suitable for lyophilization or a solid drug obtained after lyophilization, such as a lyophilized preparation, preferably a lyophilized powder for injection.

在本发明的一些实施方式中,前室筒中为注射液。In some embodiments of the invention, the anterior chamber cartridge is an injection fluid.

本发明中,如果没有特别说明,术语“近端”是指靠近注射头或者注射针的一端;术语“远端”是指远离注射头或者注射针的一端。In the present invention, unless otherwise specified, the term "proximal end" refers to the end close to the injection head or the injection needle; the term "distal end" refers to the end away from the injection head or the injection needle.

本发明中,如果没有特别说明,术语“通径”是指可通过的直径,多数情况下等于内径。对于11、13来说就是筒体的内径;12内部有槽有肋条,其通径等于内部主圆的直径(还是内径)。通径的大小并不特别限定,可根据需要进行设计,如用药量大,那通径可以大一些,用药量小,通径可以小一些。在本发明的一些实施方式中,各所述通径独立地为3-30mm,优选为5-20mm,更优选为5-15mm,特别优选为8-12mm,例如8mm、9mm、10mm、11mm或12mm。In the present invention, unless otherwise specified, the term "diameter" refers to the diameter that can pass through, and is equal to the inner diameter in most cases. For 11 and 13, it is the inner diameter of the cylinder; 12 has grooves and ribs inside, and its diameter is equal to the diameter of the inner main circle (or the inner diameter). The size of the diameter is not particularly limited, and can be designed according to needs. In some embodiments of the present invention, each of the diameters is independently 3-30mm, preferably 5-20mm, more preferably 5-15mm, particularly preferably 8-12mm, such as 8mm, 9mm, 10mm, 11mm or 12mm.

在本发明的一些实施方式中,为了便于冻干和容纳一定量的药物,前室筒长度为1-10cm,优选为2-8cm,更优选为3-6cm。In some embodiments of the present invention, in order to facilitate lyophilization and contain a certain amount of medicine, the length of the antechamber barrel is 1-10 cm, preferably 2-8 cm, more preferably 3-6 cm.

在本发明的一些实施方式中,为了容纳溶解药物的注射用溶媒,后室筒的大致长度为1-6cm,优选为2-5cm,更优选为3-4cm。In some embodiments of the present invention, the approximate length of the rear chamber barrel is 1-6 cm, preferably 2-5 cm, more preferably 3-4 cm in order to accommodate the injection vehicle for dissolving the drug.

本发明中,如果没有特别说明,术语“注射液”可以含有活性成分,也可以为不含活性成分的注射用溶媒;优选为不含活性成分的注射用溶媒。In the present invention, unless otherwise specified, the term "injection" may contain an active ingredient, or may be an injection vehicle without an active ingredient; preferably an injection vehicle without an active ingredient.

用于预装药剂的注射筒由前室筒、连接筒和后室筒组成,其中前室筒用于装载冻干好的固体药物,后室筒装载用于溶解或分散固体药物的注射用溶媒;前室筒和后室筒通过连接筒连接,中间有多个胶塞用于前室筒和后室筒的隔断,这些可以在整个注射筒内滑动,并保证前后的气密性;前室筒另一端连接注射针套件,后室筒另一端连接注射器推杆和指柄;连接筒具有多条旁通道,当推杆推动注射液向前,中间胶塞到达连接套时,前室筒和后室筒联通,注射液由后室筒进入前室筒与固体药物混合,从而完成注射前的药物准备。前室筒作为盛装液体药物的容器可以直接放入冻干机,冻干完成后可以直接与其他组件装配成型注射器。本发明减少了药物冻干后固体粉末的制备工艺流程,实现将固体药物与注射液预装在同一注射器中,可实现配药、注射一次性完成。其操作简便、避免药物封装、配药过程的污染,制备和使用成本低。The syringe used for prefilled medicament consists of a front chamber barrel, a connecting barrel and a back chamber barrel, wherein the front chamber barrel is used to load the lyophilized solid drug, and the back chamber barrel is loaded with the injection vehicle for dissolving or dispersing the solid drug. ; The front chamber barrel and the rear chamber barrel are connected by a connecting barrel, and there are multiple rubber plugs in the middle for the partition of the front chamber barrel and the rear chamber barrel. These can slide in the entire injection barrel and ensure the airtightness of the front and rear chambers; the front chamber The other end of the barrel is connected to the injection needle kit, and the other end of the rear chamber barrel is connected to the syringe push rod and the finger handle; the connecting barrel has multiple side channels, when the push rod pushes the injection forward and the middle rubber plug reaches the connecting sleeve, the front chamber barrel and the The rear chamber barrel is connected, and the injection liquid enters the front chamber barrel from the rear chamber barrel to be mixed with the solid drug, thereby completing the drug preparation before injection. As a container for liquid medicine, the anterior chamber cylinder can be directly put into the freeze-drying machine, and after the freeze-drying is completed, it can be directly assembled with other components to form a syringe. The invention reduces the preparation process of the solid powder after the freeze-drying of the medicine, realizes that the solid medicine and the injection liquid are pre-packed in the same syringe, and can realize the one-time completion of medicine dispensing and injection. It is easy to operate, avoids the pollution of medicine packaging and dispensing process, and has low preparation and use costs.

发明的有益效果Beneficial Effects of Invention

本发明的双室注射器,可在使用时将注射液与冻干药物混合,实现配药和注射一次性完成,同时解决了固液双室型注射器药物分装存在的难点。The dual-chamber syringe of the present invention can mix the injection liquid with the freeze-dried drug during use, so that the dispensing and injection can be completed at one time, and at the same time, the difficulty in drug sub-packaging of the solid-liquid dual-chamber syringe is solved.

附图说明Description of drawings

下面的附图1至附图7E中,如果没有特别说明,各附图标记的含义如下:In the following accompanying drawings 1 to 7E, unless otherwise specified, the meanings of the reference numerals are as follows:

1,药物;1a,液体药物;1b,固体药物;1, medicine; 1a, liquid medicine; 1b, solid medicine;

2,注射液;2. Injection;

10,注射筒;10a,注射筒近端;10b,注射筒远端;10, the syringe; 10a, the proximal end of the syringe; 10b, the distal end of the syringe;

11,前室筒;11a,前室筒近端(同10a);11b,前室筒远端;11, anterior chamber barrel; 11a, proximal end of anterior chamber barrel (same as 10a); 11b, distal end of anterior chamber barrel;

12,连接筒;12a,联通槽;12b,阻尼肋;12, connecting cylinder; 12a, communicating groove; 12b, damping rib;

13,后室筒;13a,后室筒近端;13b,后室筒远端(同10b);13, the rear chamber barrel; 13a, the proximal end of the rear chamber barrel; 13b, the distal end of the rear chamber barrel (same as 10b);

14,胶塞;15,隔断塞;16,推塞;14, rubber plug; 15, partition plug; 16, push plug;

21,注射头;21a,凹槽;21b,肋条;21c,针嘴;21, injection head; 21a, groove; 21b, rib; 21c, needle mouth;

22,注射针座;23,注射针;24,注射针套;22, injection needle seat; 23, injection needle; 24, injection needle cover;

31,指柄;32,推杆;33,吸水环;31, finger handle; 32, push rod; 33, suction ring;

101,前室筒中用于盛装药物的空间;102,后室筒中用于盛装注射液的空间;101, the space used to hold the medicine in the front chamber barrel; 102, the space used to hold the injection in the rear chamber barrel;

L,胶塞14距离前室筒11近端11a的距离;L, the distance between the rubber stopper 14 and the proximal end 11a of the front chamber barrel 11;

M,隔断塞15距离后室筒13端口的长度;M, the length of the blocking plug 15 from the port of the rear chamber barrel 13;

N,注射头21内腔的高度;N, the height of the inner cavity of the injection head 21;

D:注射头21内腔的内径。D: The inner diameter of the inner cavity of the injection head 21 .

图1:本发明的一个实施方案中,双室注射器的纵向剖面示意图。Figure 1: A schematic longitudinal cross-sectional view of a dual-chamber syringe in one embodiment of the present invention.

图2A:药物冻干前(盛装液体药物)的前室筒纵向剖面示意图。前室筒11和后室筒13。Figure 2A: Schematic diagram of the longitudinal section of the antechamber barrel before the drug is lyophilized (containing the liquid drug). Front chamber tube 11 and rear chamber tube 13 .

图2B:药物冻干后(盛装固体药物)的前室筒纵向剖面示意图。Figure 2B: Schematic diagram of the longitudinal section of the front chamber barrel after the drug is lyophilized (containing solid drug).

图3A:连接筒的纵向剖面示意图。Figure 3A: A schematic longitudinal cross-sectional view of the connecting cylinder.

图3B:连接筒的横截面示意图。Figure 3B: Schematic cross-sectional view of the connecting barrel.

图4:装载注射液的后室筒的纵向剖面示意图。Figure 4: Schematic longitudinal section of the back chamber barrel loaded with injection fluid.

图5A:注射头的纵向剖面示意图。Figure 5A: Schematic longitudinal section of the injection head.

图5B:图5A的局部放大图。Figure 5B: A partial enlarged view of Figure 5A.

图5C:注射头的横截面示意图。Figure 5C: Schematic cross-sectional view of the injection head.

图6:连接筒连接前后室的纵向剖面示意图。Figure 6: Schematic longitudinal section of the connecting cylinder connecting the front and rear chambers.

图7A:注射器使用前的状态(纵向剖面示意图)。Fig. 7A: The state of the syringe before use (schematic longitudinal section).

图7B:注射器前室筒11和后室筒13联通的状态(纵向剖面示意图)。FIG. 7B : a state in which the front chamber barrel 11 and the rear chamber barrel 13 of the syringe communicate with each other (a schematic longitudinal cross-sectional view).

图7C:后室筒13的注射液2全部进入前室筒11的状态(纵向剖面示意图)。FIG. 7C : a state in which the injection solution 2 of the rear chamber barrel 13 has all entered the front chamber barrel 11 (a schematic diagram of a longitudinal section).

图7D:注射器正在排空内部气体的状态(纵向剖面示意图)。Fig. 7D: A state in which the syringe is being evacuated (schematic longitudinal cross-section).

图7E:可用于注射的注射器状态(纵向剖面示意图)。Figure 7E: Syringe ready for injection (schematic longitudinal section).

具体实施方式Detailed ways

下面将结合实施例对本发明的实施方案进行详细描述,但是本领域技术人员将会理解,下列具体实施方式仅用于说明本发明,而不应视为限定本发明的范围。The embodiments of the present invention will be described in detail below with reference to the examples, but those skilled in the art will understand that the following specific embodiments are only used to illustrate the present invention, and should not be regarded as limiting the scope of the present invention.

(1)关于注射器的结构(1) About the structure of the syringe

图1所示,用于预装药物的注射筒10由前室筒11、连接筒12和后室筒13组成;前室筒11的远端11b和后室筒13的近端13a通过连接筒12连接;前室筒11内有胶塞14,距离前室筒11近端11a的距离为L;后室筒13内有两个胶塞,一个是靠近后室筒13近端13a的隔断塞15,用于前室筒11和后室筒13的隔断;另一个是位于后室筒13远端13b的推塞16;前室筒11、连接筒12和后室筒13的通径相同,胶塞14、隔断塞15和推塞16都可以在前室筒内11、连接筒12和后室筒13内滑动,并能够保持气密性。As shown in FIG. 1, the syringe 10 for prefilled medicine is composed of a front chamber barrel 11, a connecting barrel 12 and a rear chamber barrel 13; the distal end 11b of the front chamber barrel 11 and the proximal end 13a of the rear chamber barrel 13 pass through the connecting barrel 12 is connected; there is a rubber plug 14 in the front chamber barrel 11, and the distance from the proximal end 11a of the front chamber barrel 11 is L; there are two rubber plugs in the rear chamber barrel 13, one is a blocking plug close to the proximal end 13a of the rear chamber barrel 13 15, for the partition of the front chamber barrel 11 and the rear chamber barrel 13; the other is the push plug 16 located at the distal end 13b of the rear chamber barrel 13; the front chamber barrel 11, the connecting barrel 12 and the rear chamber barrel 13 have the same diameter, The rubber plug 14 , the blocking plug 15 and the push plug 16 can all slide in the front chamber barrel 11 , the connecting barrel 12 and the rear chamber barrel 13 , and can maintain air tightness.

注射筒10的近端10a(也是前室筒11的近端11a)与注射头21连接;注射头21与注射针座22相连,两者通过螺纹的形式连接;注射针座22固定了注射针23,同时还连接注射针套24,用于保护注射针23。The proximal end 10a of the syringe barrel 10 (also the proximal end 11a of the front chamber barrel 11) is connected with the injection head 21; the injection head 21 is connected with the injection needle seat 22, and the two are connected in the form of threads; the injection needle seat 22 fixes the injection needle 23 , and also connected to the injection needle cover 24 for protecting the injection needle 23 .

注射筒10的远端10b(也是后室筒13的远端13b)连接指柄31;后室筒13内的推塞16连接推杆32,指柄31和推杆32构成注射器单手注射操作的结构;推杆32与推塞16通过螺纹等形式连接;在靠近推塞16的推杆32一侧有一吸水环33。The distal end 10b of the syringe barrel 10 (also the distal end 13b of the rear chamber barrel 13) is connected to the finger handle 31; the push plug 16 in the rear chamber barrel 13 is connected to the push rod 32, and the finger handle 31 and the push rod 32 constitute a one-handed injection operation of the syringe The push rod 32 is connected with the push plug 16 through threads, etc.; there is a water suction ring 33 on the side of the push rod 32 close to the push plug 16.

更详细的结构方案描述如下:A more detailed structural scheme is described as follows:

如图2A和2B所示,前室筒11和胶塞14构成的容器101可用于盛装液体药物1a并冻干;冻干后的固体药物1b可直接用于注射器的封装;胶塞14距离前室筒11近端11a的距离为L;优选地,L为隔断塞15厚度的1-3倍,更优选地,L为隔断塞15厚度的1.2-1.8倍例如1.2、1.3、1.4、1.5、1.6、1.7或1.8倍;特别优选为1.5倍。As shown in Figures 2A and 2B, the container 101 formed by the front chamber barrel 11 and the rubber stopper 14 can be used to hold the liquid medicine 1a and freeze-dried; the freeze-dried solid medicine 1b can be directly used for the packaging of the syringe; The distance from the proximal end 11a of the chamber barrel 11 is L; preferably, L is 1-3 times the thickness of the blocking plug 15, more preferably, L is 1.2-1.8 times the thickness of the blocking plug 15, such as 1.2, 1.3, 1.4, 1.5, 1.6, 1.7 or 1.8 times; particularly preferably 1.5 times.

不拘于理论的限制,隔断塞15向前运动时胶塞14也向前运动,需要保证隔断塞15在刚好全部进入连接筒12时,胶塞14全部或者部分还在前室筒11中,避免前后室混药过程中前室筒11与注射头21连通。如果L过短,则胶塞14会进入注射头21,前室筒11与注射头21联通;如果L过长,虽然不影响功能实现,但也增加了前室筒的无用长度,注射器整体变长。Without being bound by theoretical limitations, when the partition plug 15 moves forward, the rubber plug 14 also moves forward. It is necessary to ensure that when the partition plug 15 just fully enters the connecting cylinder 12, all or part of the rubber plug 14 is still in the front chamber cylinder 11 to avoid. During the mixing process of the front and rear chambers, the front chamber barrel 11 communicates with the injection head 21 . If L is too short, the rubber stopper 14 will enter the injection head 21, and the front chamber barrel 11 is communicated with the injection head 21; if L is too long, although it does not affect the realization of the function, it also increases the useless length of the front chamber barrel, and the syringe as a whole becomes long.

在本发明的一些实施方式中,L满足隔断塞15在刚好全部进入连接筒12时,胶塞14全部或者部分还在前室筒11中。In some embodiments of the present invention, L satisfies that when the blocking plug 15 just fully enters the connecting cylinder 12 , all or part of the rubber plug 14 is still in the front chamber cylinder 11 .

在本发明的一些实施方式中,L满足隔断塞15在刚好全部进入连接筒12时,前室筒11与注射头21不连通。In some embodiments of the present invention, L satisfies that when the blocking plug 15 just fully enters the connecting barrel 12 , the front chamber barrel 11 is not in communication with the injection head 21 .

图3A和图3B所示,连接筒12用于连接前室筒11和后室筒13,连接筒12中间部位的长度H大于隔断塞15的厚度(例如长度H为隔断塞15厚度的1.2-1.8倍,优选1.5倍);优选地,长度H小于隔断塞15和推塞16的厚度之和。连接筒12中间部位设置了连通槽12a和阻尼肋12b;联通槽12a用于连通前室筒11和后室筒13,当隔断塞15滑动到连接筒12中间部位时,前室筒11和后室筒13联通;联通槽12a的数量为2到4个,不宜过多或过少,数量过多,则联通槽残留注射液过多,数量过少则注射液流动慢,需用较大力气操作;阻尼肋12b用于增加隔断塞15经过连接筒12的阻力,避免操作时用力过大,隔断塞15直接冲过连接筒12,起不到连通前室筒和后室筒的作用;阻尼肋12b数量以4为宜。3A and 3B, the connecting cylinder 12 is used to connect the front chamber cylinder 11 and the rear chamber cylinder 13, and the length H of the middle part of the connecting cylinder 12 is greater than the thickness of the blocking plug 15 (for example, the length H is 1.2-1. 1.8 times, preferably 1.5 times); preferably, the length H is less than the sum of the thicknesses of the blocking plug 15 and the push plug 16 . A communication groove 12a and a damping rib 12b are provided in the middle part of the connecting cylinder 12; the communication groove 12a is used to communicate the front chamber cylinder 11 and the rear chamber cylinder 13. When the blocking plug 15 slides to the middle part of the connecting cylinder 12, the front chamber cylinder 11 and the rear chamber cylinder The chamber tube 13 is connected; the number of the communication grooves 12a is 2 to 4, which should not be too much or too little. Operation; the damping rib 12b is used to increase the resistance of the blocking plug 15 passing through the connecting cylinder 12, to avoid excessive force during operation, and the blocking plug 15 directly rushes through the connecting cylinder 12, and cannot achieve the function of connecting the front chamber cylinder and the rear chamber cylinder; damping The number of ribs 12b is preferably four.

不拘于理论的限制,连接筒12的阻尼肋12b圈起来的内圈直径小于隔断塞15的外径,主要作用是减缓隔断塞的运动,避免隔断塞15一下子运动冲过连接筒12。Without being bound by theoretical limitations, the diameter of the inner ring circled by the damping rib 12b of the connecting cylinder 12 is smaller than the outer diameter of the blocking plug 15 .

图4所示,后室筒13和隔断塞15、推塞16构成的容器102,可用于预充填注射液2;隔断塞15位于后室筒13近端13a,距离后室筒13端口13a的长度为M;优选地,M长度为隔断塞15厚度的0.5到1倍。As shown in FIG. 4 , the container 102 composed of the rear chamber barrel 13, the blocking plug 15 and the push plug 16 can be used for pre-filling the injection 2; The length is M; preferably, the M length is 0.5 to 1 times the thickness of the blocking plug 15 .

不拘于理论的限制,在注射器装配过程,M不宜为0,否则隔断塞15容易由于误触掉出来,或者由于误触导致隔断塞15进入连接筒12,导致前后室联通;M也不宜过长,否则导致注射器整体长度过长。因此优选M长度为隔断塞15厚度的0.5到1倍。Without being bound by the limitation of theory, in the process of assembling the syringe, M should not be 0, otherwise the blocking plug 15 will easily fall out due to accidental touch, or the blocking plug 15 will enter the connecting cylinder 12 due to accidental touch, resulting in the communication between the front and rear chambers; M should not be too long. , otherwise the overall length of the syringe will be too long. Therefore, the M length is preferably 0.5 to 1 times the thickness of the blocking plug 15 .

图1所示,推杆32穿过指柄31与吸水环33、推塞16相连,指柄31中间开口直径小于吸水环33和推塞16的直径,可防止推杆32的误拔出;当推塞16经过连接筒12的中间部位时,吸水环可以33吸收联通槽12a内残留的液体,避免残留的液体流出注射器外。As shown in FIG. 1 , the push rod 32 is connected to the water suction ring 33 and the push plug 16 through the finger handle 31, and the diameter of the middle opening of the finger handle 31 is smaller than the diameter of the water suction ring 33 and the push plug 16, which can prevent the push rod 32 from being pulled out by mistake; When the push plug 16 passes through the middle part of the connecting cylinder 12, the water suction ring 33 can absorb the residual liquid in the communication groove 12a, so as to prevent the residual liquid from flowing out of the syringe.

图5A、图5B和图5C所示,注射头21内腔的内径D与比胶塞14外径大5%至10%,既可以保证注射器在注射时操作较为轻松,也可以减少液体注射药物在注射器中的残留;注射头21的内腔高度N大于胶塞14的厚度,约为其1.2-1.4倍;注射头21内腔的四周和底部有凹槽21a,凹槽21a连通针嘴21c,其作用是保证液体能够绕过胶塞14进入注射针23,凹槽21a数量为2-4条;注射头21内腔的四周有肋条21b,数量为3-6条,这些肋条等间距圆周排列,围起来的内圆直径等于胶塞14直径,其作用是保证胶塞14在注射头21内腔中保持同轴(胶塞14在注射头21中不发生偏转),避免胶塞14偏转导致腔内残余过多注射液。As shown in FIGS. 5A, 5B and 5C, the inner diameter D of the inner cavity of the injection head 21 is 5% to 10% larger than the outer diameter of the rubber stopper 14, which can not only ensure that the syringe is easy to operate during injection, but also can reduce the amount of liquid to inject drugs. Residues in the syringe; the height N of the inner cavity of the injection head 21 is greater than the thickness of the rubber plug 14, which is about 1.2-1.4 times; the circumference and bottom of the inner cavity of the injection head 21 have grooves 21a, and the grooves 21a communicate with the needle nozzle 21c , its function is to ensure that the liquid can bypass the rubber stopper 14 and enter the injection needle 23, the number of grooves 21a is 2-4; there are ribs 21b around the inner cavity of the injection head 21, the number is 3-6, these ribs are equally spaced around the circumference Arranged, the diameter of the enclosed inner circle is equal to the diameter of the rubber stopper 14, and its function is to ensure that the rubber stopper 14 remains coaxial in the inner cavity of the injection head 21 (the rubber stopper 14 does not deflect in the injection head 21), so as to prevent the rubber stopper 14 from deflecting This results in excess injection fluid remaining in the cavity.

(2)关于注射器的装料方法(2) About the charging method of the syringe

灭菌后的前室筒11和胶塞14构成一种容器101,图2A所示,容器101盛装液体药物1a,在无菌洁净环境下冻干,冻干后形成固体块状药物,图2B为装载冻干物料的前室状态。The sterilized front chamber barrel 11 and the rubber stopper 14 constitute a container 101. As shown in FIG. 2A, the container 101 contains a liquid medicine 1a, which is freeze-dried in a sterile and clean environment, and a solid block medicine is formed after freeze-drying, as shown in FIG. 2B. The state of the front chamber for loading lyophilized materials.

灭菌后的后室筒13和推塞16、指柄31、推杆32、吸水环33组装完毕,形成可容器102,图4所示;在无菌洁净环境下,可手动或依靠其它移液装置向容器102内分装注射液2,移液后装入隔断塞15,图4为装载注射液的后室状态。The sterilized rear chamber tube 13, the push plug 16, the finger handle 31, the push rod 32, and the water suction ring 33 are assembled to form a container 102, as shown in FIG. The liquid device dispenses the injection solution 2 into the container 102, and installs the blocking plug 15 after pipetting. Fig. 4 shows the state of the rear chamber for loading the injection solution.

图6(整个图6即为注射筒10)为通过连接筒12连接前后室的状态,即完成注射筒10的药物和注射液的装料;在无菌洁净环境下,继续组装针头部分组件,最终完成注射器的组装。Fig. 6 (the entire Fig. 6 is the syringe 10) is the state in which the front and rear chambers are connected through the connecting barrel 12, that is, the filling of the medicine and the injection liquid in the syringe 10 is completed; in a sterile and clean environment, continue to assemble the needle part assembly, Finally complete the assembly of the syringe.

(3)关于注射器的使用方法/注射方法(3) How to use the syringe/injection method

图7A为注射器使用前的状态,使用时注射器针头垂直向上,摘掉注射针套24;推动推杆32,注射筒10内的胶塞14、隔断塞15、推塞16和注射液2向前移动;当隔断塞15移动至连接筒12的中间部位时,图7B所示,前室筒11和后室筒13通过连接筒12的连通槽12a连通;推杆32继续推动,胶塞14和推塞16向前移动,注射液2进入前室筒11,胶塞14进入注射头21的内腔,注射筒10内的气体通过注射针23排出,图7C所示;当推塞16达到隔断塞15时,注射液2全部进入前室筒11,冻干药物1b与注射液2混合溶解,形成注射药液3,图7D所示;推杆32继续向前,将前室筒11中的空气排出,形成可用于注射的注射器状态,图7E所示。Fig. 7A shows the state of the syringe before use. When in use, the needle of the syringe is vertically upward, and the injection needle cover 24 is removed; the push rod 32 is pushed, and the rubber plug 14, the partition plug 15, the push plug 16 and the injection solution 2 in the syringe 10 move forward When the blocking plug 15 moves to the middle part of the connecting cylinder 12, as shown in FIG. 7B, the front chamber cylinder 11 and the rear chamber cylinder 13 are communicated through the communication groove 12a of the connecting cylinder 12; the push rod 32 continues to push, and the rubber plug 14 and The push plug 16 moves forward, the injection liquid 2 enters the front chamber barrel 11, the rubber plug 14 enters the inner cavity of the injection head 21, and the gas in the syringe barrel 10 is discharged through the injection needle 23, as shown in FIG. 7C; when the push plug 16 reaches the partition When plug 15, all the injection liquid 2 enters the front chamber barrel 11, and the freeze-dried drug 1b is mixed and dissolved with the injection liquid 2 to form the injection liquid 3, as shown in FIG. 7D; The air is expelled, resulting in a syringe ready for injection, as shown in Figure 7E.

尽管本发明的具体实施方式已经得到详细的描述,本领域技术人员将会理解。根据已经公开的所有教导,可以对那些细节进行各种修改和替换,这些改变均在本发明的保护范围之内。本发明的全部范围由所附权利要求及其任何等同物给出。Although specific embodiments of the present invention have been described in detail, those skilled in the art will understand. Various modifications and substitutions of those details may be made within the scope of the present invention in light of all the teachings disclosed. The full scope of the invention is given by the appended claims and any equivalents thereof.

Claims (19)

1.一种注射器,包括注射头(21)、注射筒(10)、推塞(16)和推杆(32),其中:1. A syringe comprising an injection head (21), a syringe barrel (10), a push plug (16) and a push rod (32), wherein: 所述注射筒(10)包括前室筒(11)和后室筒(13),其中,前室筒(11)是可拆装的;The injection barrel (10) includes a front chamber barrel (11) and a rear chamber barrel (13), wherein the front chamber barrel (11) is detachable; 优选地,前室筒(11)能够用于盛装液体并用于冻干。Preferably, the antechamber (11) can be used to contain liquids and for lyophilization. 2.根据权利要求1所述的注射器,其中,前室筒(11)内有胶塞(14)。2. The syringe according to claim 1, wherein a rubber stopper (14) is provided in the front chamber barrel (11). 3.根据权利要求1至2中任一权利要求所述的注射器,其中,后室筒(13)内有靠近后室筒(13)近端(13a)的隔断塞(15),用于前室筒(11)和后室筒(13)的隔断;以及位于后室筒(13)远端(13b)的推塞(16)。3. The syringe according to any one of claims 1 to 2, wherein the rear chamber barrel (13) has a blocking plug (15) close to the proximal end (13a) of the rear chamber barrel (13) for the front A partition between the chamber barrel (11) and the rear chamber barrel (13); and a push plug (16) located at the distal end (13b) of the rear chamber barrel (13). 4.根据权利要求3所述的注射器,其中,胶塞(14)到前室筒(11)近端(11a)的垂直距离表示为L,L为隔断塞15厚度的1-3倍;4. The syringe according to claim 3, wherein the vertical distance from the rubber stopper (14) to the anterior chamber barrel (11) proximal end (11a) is represented as L, and L is 1-3 times of the thickness of the blocking plug 15; 优选地,L为隔断塞15厚度的1.2-1.8倍;Preferably, L is 1.2-1.8 times the thickness of the partition plug 15; 更优选地,L为隔断塞15厚度的1.4-1.6倍。More preferably, L is 1.4-1.6 times the thickness of the blocking plug 15 . 5.根据权利要求1至4中任一权利要求所述的注射器,其中,所述前室筒(11)和后室筒(13)的通径相同,并且均为独立管体。5. The syringe according to any one of claims 1 to 4, wherein the front chamber barrel (11) and the rear chamber barrel (13) have the same diameter and are both independent tubes. 6.根据权利要求1至5中任一权利要求所述的注射器,其中,前室筒(11)的远端(11b)和后室筒(13)的近端(13a)通过连接筒(12)连接,连接筒(12)的通径与前室筒(11)和后室筒(13)的通径相同。6. The syringe according to any one of claims 1 to 5, wherein the distal end (11b) of the anterior chamber barrel (11) and the proximal end (13a) of the posterior chamber barrel (13) are connected by a connecting barrel (12) ) connection, the diameter of the connecting cylinder (12) is the same as that of the front chamber cylinder (11) and the rear chamber cylinder (13). 7.根据权利要求6所述的注射器,其中,连接筒(12)中间部位的长度表示为H,H为隔断塞15厚度的1.2-1.8倍,优选为1.4-1.6倍;7. The syringe according to claim 6, wherein the length of the middle part of the connecting cylinder (12) is represented as H, and H is 1.2-1.8 times the thickness of the blocking plug 15, preferably 1.4-1.6 times; 优选地,H小于隔断塞15和推塞16的厚度之和。Preferably, H is less than the sum of the thicknesses of the blocking plug 15 and the push plug 16 . 8.根据权利要求6至7中任一权利要求所述的注射器,其中,连接筒(12)中间部位设有一个或多个连通槽(12a);联通槽(12a)用于连通前室筒(11)和后室筒(13),当隔断塞(15)滑动到连接筒(12)中间部位时,前室筒(11)和后室筒(13)联通;8. The syringe according to any one of claims 6 to 7, wherein one or more communication grooves (12a) are provided in the middle part of the connecting cylinder (12); the communication grooves (12a) are used to communicate with the front chamber cylinder (11) and the rear chamber cylinder (13), when the blocking plug (15) slides to the middle part of the connecting cylinder (12), the front chamber cylinder (11) and the rear chamber cylinder (13) are communicated; 优选地,联通槽(12a)的数量为1-6个,更优选2、3或4个。Preferably, the number of communication grooves (12a) is 1-6, more preferably 2, 3 or 4. 9.根据权利要求6至8中任一权利要求所述的注射器,其中,连接筒(12)中间部位设有一个或多个阻尼肋(12b);9. The syringe according to any one of claims 6 to 8, wherein one or more damping ribs (12b) are provided in the middle part of the connecting barrel (12); 优选地,阻尼肋(12b)的数量为1-6条,更优选2、3或4条。Preferably, the number of damping ribs (12b) is 1-6, more preferably 2, 3 or 4. 10.根据权利要求3至9中任一权利要求所述的注射器,其中,隔断塞(15)到后室筒(13)近端(13a)的垂直距离表示为M,M为隔断塞(15)厚度的0.5到1倍。10. The syringe according to any one of claims 3 to 9, wherein the vertical distance from the blocking plug (15) to the proximal end (13a) of the rear chamber barrel (13) is represented as M, where M is the blocking plug (15) ) 0.5 to 1 times the thickness. 11.根据权利要求1至10中任一权利要求所述的注射器,其中,注射筒(10)的近端(10a)与注射头(21)连接。11. Syringe according to any one of claims 1 to 10, wherein the proximal end (10a) of the syringe barrel (10) is connected to the injection head (21). 12.根据权利要求11所述的注射器,其中,12. The syringe of claim 11, wherein, 注射头(21)内腔的内径D与比胶塞(14)外径大5%至10%;和The inner diameter D of the inner cavity of the injection head (21) is 5% to 10% larger than the outer diameter of the rubber stopper (14); and 注射头(21)的内腔高度N大于胶塞(14)的厚度,优选N为胶塞(14)厚度的1.2-1.4倍。The inner cavity height N of the injection head (21) is greater than the thickness of the rubber stopper (14), preferably N is 1.2-1.4 times the thickness of the rubber stopper (14). 13.根据权利要求11至12中任一权利要求所述的注射器,其中,13. The syringe of any one of claims 11 to 12, wherein, 注射头(21)内腔的四周和底部有凹槽(21a),凹槽(21a)连通针嘴(21c),There are grooves (21a) around and at the bottom of the inner cavity of the injection head (21), and the grooves (21a) communicate with the needle nozzle (21c), 优选地,凹槽(21a)为1-6条,优选为2、3或4条。Preferably, there are 1-6 grooves (21a), preferably 2, 3 or 4 grooves. 14.根据权利要求11至13中任一权利要求所述的注射器,其中,注射头(21)内腔的四周有至少2条肋条(21b),所述肋条等间距圆周排列,并且全部肋条围起来的内圆直径等于胶塞(14)直径;14. The syringe according to any one of claims 11 to 13, wherein at least 2 ribs (21b) are arranged around the inner cavity of the injection head (21), the ribs are circumferentially arranged at equal intervals, and all the ribs surround The diameter of the inner circle is equal to the diameter of the rubber stopper (14); 优选地,肋条为3-12条,优选为3-6条。Preferably, the number of ribs is 3-12, preferably 3-6. 15.根据权利要求11至14中任一权利要求所述的注射器,其中,注射头(21)与注射针座(22)相连;注射针座(22)固定了注射针(23);15. The syringe according to any one of claims 11 to 14, wherein the injection head (21) is connected to the injection needle seat (22); the injection needle seat (22) fixes the injection needle (23); 优选地,注射头(21)与注射针座(22)通过螺纹的形式连接;Preferably, the injection head (21) and the injection needle seat (22) are connected in the form of threads; 优选地,注射针座(22)还连接注射针套(24)。Preferably, the injection needle seat (22) is also connected to the injection needle cover (24). 16.根据权利要求1至15中任一权利要求所述的注射器,其中,后室筒(13)内的推塞(16)连接推杆(32);16. Syringe according to any one of claims 1 to 15, wherein a push plug (16) in the rear chamber barrel (13) is connected to the push rod (32); 优选地,推杆(32)与推塞(16)通过螺纹的形式连接;Preferably, the push rod (32) and the push plug (16) are connected in the form of threads; 优选地,注射筒(10)的远端(10b)连接有指柄(31);Preferably, the distal end (10b) of the syringe (10) is connected with a finger handle (31); 优选地,指柄(31和推杆(32)构成注射器单手注射操作的结构;Preferably, the finger handle (31 and the push rod (32) constitute the structure of the syringe for one-handed injection operation; 优选地,在靠近推塞(16)的推杆(32)一侧有一吸水环(33),推杆(32)穿过指柄(31)与吸水环(33)、推塞(16)相连;Preferably, there is a water suction ring (33) on the side of the push rod (32) close to the push plug (16), and the push rod (32) is connected to the water suction ring (33) and the push plug (16) through the finger handle (31). ; 优选地,指柄(31)中间开口直径小于吸水环(33)和推塞(16)的直径。Preferably, the diameter of the middle opening of the finger handle (31) is smaller than the diameters of the water suction ring (33) and the push plug (16). 17.根据权利要求1至16中任一权利要求所述的注射器,其中,前室筒(11)和胶塞(14)构成的容器(101)可用于盛装液体药物并冻干;17. The syringe according to any one of claims 1 to 16, wherein the container (101) formed by the front chamber barrel (11) and the rubber stopper (14) can be used to hold liquid medicines and freeze-dried; 优选地,冻干后得到的固体药物可直接用于注射器的封装。Preferably, the solid drug obtained after lyophilization can be directly used for packaging of the syringe. 18.根据权利要求1至17中任一权利要求所述的注射器,其中,后室筒(13)和隔断塞(15)和推塞(16)构成的容器(102),可用于预充填注射液。18. Syringe according to any one of claims 1 to 17, wherein the rear chamber barrel (13) and the blocking plug (15) and the push plug (16) constitute a container (102) that can be used for prefilled injections liquid. 19.权利要求1至18中任一项所述的注射器的装料方法,包括如下步骤:19. The charging method of the syringe according to any one of claims 1 to 18, comprising the steps of: ①将灭菌后的前室筒(11)或者灭菌后的前室筒(11)和胶塞(14)构成的容器(101)盛装固体药物或液体药物;优选地,液体药物在无菌洁净环境下冻干,冻干后得到固体药物;① The sterilized front chamber barrel (11) or the container (101) formed by the sterilized front chamber barrel (11) and the rubber stopper (14) is filled with solid medicine or liquid medicine; Freeze-dried in a clean environment to obtain solid drug after freeze-drying; ②将灭菌后的后室筒(13)和推塞(16)、可选的指柄(31)、推杆(32)以及可选的吸水环(33)进行组装,形成容器(102);② Assemble the sterilized rear chamber cylinder (13), push plug (16), optional finger handle (31), push rod (32) and optional water suction ring (33) to form a container (102) ; ③在无菌洁净环境下,向容器(102)内分装注射液,移液后装入隔断塞(15)。③ In a sterile and clean environment, sub-fill the injection solution into the container (102), and then install the partition plug (15) after pipetting.
CN202110003783.9A 2021-01-04 2021-01-04 A dual-chamber syringe and a charging method Pending CN114712618A (en)

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