WO2024021333A1 - 输液容器用无内盖式覆膜盖及输液容器 - Google Patents

输液容器用无内盖式覆膜盖及输液容器 Download PDF

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Publication number
WO2024021333A1
WO2024021333A1 PCT/CN2022/127542 CN2022127542W WO2024021333A1 WO 2024021333 A1 WO2024021333 A1 WO 2024021333A1 CN 2022127542 W CN2022127542 W CN 2022127542W WO 2024021333 A1 WO2024021333 A1 WO 2024021333A1
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Prior art keywords
cover
puncture
film
infusion
covered
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PCT/CN2022/127542
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English (en)
French (fr)
Inventor
刘祥华
谭益民
刘师宏
夏岳韬
郑湘明
陈一
刘超
Original Assignee
湖南千山制药机械股份有限公司
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Publication of WO2024021333A1 publication Critical patent/WO2024021333A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports

Definitions

  • the present invention relates to the technical field of medical packaging, and in particular, to an inner-coverless film-covered cover for an infusion container.
  • the present invention also relates to an infusion container including the above-mentioned inner cover-less film-covered lid for an infusion container.
  • common infusion container covers generally have a combined structure, which mainly includes an outer cover, an inner plug, and an inner cover.
  • the outer cover accommodates the inner plug, and the inner cover is arranged inside the outer cover to fix the inner plug, allowing the needle to puncture.
  • the inner plug prevents the overall structure from loosening during infusion, and also prevents the inner plug from contacting the liquid.
  • the inner plug mainly prevents the liquid from leaking out of the infusion container after the inner cover is punctured by the needle.
  • the inner cover needs to fix the inner plug to prevent the inner plug from loosening, it has certain requirements for its strength. It also needs to avoid being punctured by the needle without breaking, which has certain requirements for its toughness. At the same time, the inner cover is in direct contact with the liquid. There are certain requirements for the particularity of its materials. Based on the above requirements, the material cost of the inner cover is relatively expensive, which increases the overall manufacturing cost of the infusion container cover.
  • the invention provides an inner-cover-less film-covered cover for an infusion container and an infusion container to solve the technical problem of high manufacturing cost of the infusion container cover due to the high material cost of the inner cover of the existing infusion container cover.
  • an inner-capless film-covered cover for an infusion container which includes an outer cover.
  • the outer cover includes a puncture chamber.
  • An inner plug is arranged in the puncture chamber.
  • the top of the puncture chamber is sealed, and the bottom of the puncture chamber is provided with a plug.
  • the film cover also includes a barrier film covering the lower end surface of the inner pressure edge for sealing the bottom of the puncture cavity.
  • a recessed bending angle is provided between the inner pressing edge and the outer cover to facilitate length determination and bending shaping of the inner pressing edge during hot pressing.
  • the thickness of the corner between the inner pressure edge and the outer cover where the bending concave angle is recessed is in a range of 0.4-0.8 mm.
  • a chamfer is provided at the corner between the inner surface of the inner pressure edge and the lower end surface of the inner pressure edge.
  • the thickness of the inner pressure edge ranges from 1.0 to 2.0 mm.
  • the clearance distance is ⁇ 4.5mm.
  • the bottom of the inner plug is recessed upward with a centrally arranged first inner spherical surface, and the inner pressing edge is provided with an upwardly protruding pressing boss for pressing against the first inner spherical surface.
  • the corner between the lower end surface of the inner plug and the first inner spherical surface is provided with a mounting protrusion protruding downward, and the upper end surface of the inner pressure edge is recessed with a mounting protrusion arranged corresponding to the installation protrusion for embedding the installation protrusion. embedded groove.
  • an infusion container which includes the above-mentioned inner-coverless film-covered cover for an infusion container.
  • the infusion container of the present invention uses an inner-cover-less film-covered cover.
  • an outer cover with a puncture cavity is obtained through an injection molding process to insert the inner plug into the puncture cavity.
  • the top of the puncture cavity is in a sealed state to avoid contact between the inner plug and the external environment.
  • Contamination due to contact, the inner pressure edge and the outer cover are integrally formed by the injection molding process, and the outer cover is extended axially to form an unbent inner pressure edge during injection molding, and then the inner pressure edge is bent toward the inner plug through the hot pressing process, and the inner pressure edge is bent towards the inner plug.
  • the hot pressing and bending process the compactness of the matrix increases, and the strength and surface smoothness of the matrix increase.
  • the bent and formed inner crimp completely adheres to and covers the surface of the inner plug, with high reliability.
  • the barrier is removed through the welding process.
  • the membrane welding covers the lower end surface of the inner pressure edge to seal the bottom of the puncture chamber to prevent the medicinal solution in the infusion container from contacting the inner plug and contamination.
  • the barrier film can also prevent the inner plug chips generated by the puncture needle from falling into the medicine. In the liquid, this solution accommodates the inner plug through the outer cover, and then cooperates with the inner pressure edge and the barrier film to fix and seal the inner plug.
  • Figure 1 is a schematic structural diagram of an inner-cover-less film-covered cover for an infusion container according to a preferred embodiment of the present invention
  • Figure 2 is a schematic cross-sectional view of an inner-cover-less film-covered cover for an infusion container according to a preferred embodiment of the present invention.
  • Figure 1 is a schematic structural diagram of a film-covered lid without an inner cover for an infusion container according to a preferred embodiment of the present invention
  • Figure 2 is a schematic cross-sectional view of a film-covered cover without an inner cover for an infusion container according to a preferred embodiment of the present invention.
  • the infusion container of this embodiment uses an inner-cover-less film cover, including an outer cover 1.
  • the outer cover 1 includes a puncture chamber 11, and an inner plug 2 is arranged in the puncture chamber 11.
  • the puncture chamber 11 The top of the puncture chamber 11 is sealed, and the bottom of the puncture chamber 11 is provided with an inner pressure edge 3 for bending and molding by hot pressing to hold the inner plug 2 in place.
  • the lower end surface of the inner pressure edge 3 is also attached with a seal for sealing the bottom of the puncture chamber 11.
  • Barrier film 4 Specifically, the infusion container of the present invention is covered with a non-inner cover. First, the outer cover 1 with the puncture cavity 11 is obtained through an injection molding process, so that the inner plug 2 is inserted into the puncture cavity 11.
  • the top of the puncture cavity 11 is sealed. state to avoid contamination caused by contact between the inner plug 2 and the external environment.
  • the inner pressure edge 3 and the outer cover 1 are integrally formed using an injection molding process. During the injection molding, the outer cover 1 extends axially to form an unbent inner pressure edge 3, which is then heated through a hot pressing process.
  • the inner pressure edge 3 is bent toward the direction of the inner plug 2, and the density of the base body of the inner pressure edge 3 increases during the hot pressing and bending process, and the strength and surface smoothness of the base body increase.
  • the bent inner pressure edge 3 is completely close to and Covered on the surface of the inner plug 2, the reliability is high.
  • the barrier film 4 is welded and covered on the lower end surface of the inner pressure edge 3 through a welding process to seal the bottom of the puncture cavity 11 and prevent the medical solution in the infusion container from interfacing with the inner plug. 2, and the barrier film 4 can also prevent the chips of the inner plug 2 produced by the puncture needle from falling into the liquid.
  • This solution uses the outer cover 1 to accommodate the inner plug 2, and then cooperates with the inner pressure edge 3 and the barrier film 4 , to fix and seal the inner plug 2.
  • the inner pressure edge 3 and the barrier film 4 work together to replace the inner cover with high material requirements and relatively expensive price.
  • the manufacturing cost of the infusion container cover is greatly reduced, and the barrier film 4 is less difficult to puncture than the inner cover, making it easy for medical staff to use, highly practical, and suitable for widespread promotion and application.
  • the inner plug 2 is made of silicone with certain elasticity.
  • a recessed bending angle 33 is provided between the inner pressing edge 3 and the outer cover 1 to facilitate length determination and bending of the inner pressing edge 3 during hot pressing.
  • the setting of the bending concave angle 33 makes it easy to bend the inner pressure edge 3 during hot pressing to ensure the level of the lower end surface of the inner pressure edge 3 after bending and forming, thereby improving the sealing after welding and covering the barrier film 4, and bending.
  • the folding length easily depends on the position of the bending concave corner 33, so that the dimensions of the inner pressure edge 3 are relatively fixed, which facilitates injection molding. It should be understood that the base thickness of the bending concave corner 33 is thin, and after hot pressing, the position of the bending concave corner 33 is partially welded and strengthened to a certain extent, thereby improving the bearing capacity of the bending part.
  • the thickness of the corner between the inner pressure edge 3 and the outer cover 1 where the bent recessed corner 33 is recessed ranges from 0.3 to 1.0 mm. Specifically, when the thickness of the corner between the inner pressure edge 3 and the outer cover 1 where the bending recessed corner 33 is provided is between 0.3-1.0 mm, the inner pressure edge 3 is easy to bend, and the inner pressure edge 3 and The strength of the corner between the outer cover 1 and the outer cover 1 is guaranteed; when the thickness of the corner between the inner pressure edge 3 and the outer cover 1 is less than 0.3mm, The strength of the bending recessed corner 33 in the recess between the inner pressure edge 3 and the outer cover 1 cannot be guaranteed, and it is easy to break during hot pressing or during use; when the recess between the inner pressure edge 3 and the outer cover 1 is not When the thickness of the corner of the bent concave corner 33 is greater than 1.0 mm, the inner pressure edge 3 is not easy to bend.
  • the corner of the free end of the inner pressure edge 3 away from the inner plug 2 is provided with a chamfer. Specifically, chamfering the material at the corner of the free end of the inner pressure edge 3 away from the inner plug 2 facilitates the upward bending and shaping of the inner pressure edge 3 through hot pressing.
  • the thickness of the inner pressure edge 3 ranges from 0.8 to 3.0 mm. Specifically, when the thickness of the inner pressure edge 3 is between 0.8-3.0mm, the strength of the inner pressure edge 3 is reliable, achieving stable support for the inner plug 2 and facilitating bending and molding during hot pressing; when the inner pressure edge 3 When the thickness of the inner pressure edge 3 is less than 0.8mm, the strength of the inner pressure edge 3 cannot be guaranteed, and it may not be possible to achieve stable support for the inner plug 2 when the puncture needle is punctured; when the thickness of the inner pressure edge 3 is greater than 3.0mm, the inner pressure edge 3 will bend When the internal stress is too large, it is easy to break at the bend and it is difficult to bend.
  • the thickness of the inner pressure edge 3 needs to be strictly guaranteed to ensure reliable support. It should be understood that in this application, due to the arrangement of the bending recessed corners 33, even if the thickness of the inner pressure edge 3 is appropriately increased, bending can be achieved. Preferably, the thickness of the inner pressure edge 3 ranges from 1.0 to 2.0 mm.
  • the clearance distance can also effectively ensure that the inner plug 2 is overly compacted, eliminating the pressure of the inner plug 2 stress, giving the inner plug 2 a relatively free space to stretch during puncture, fully preventing the elastic effect of the inner plug 2 itself, minimizing the cutting resistance generated during puncture, and eliminating or minimizing the chips generated by the inner plug 2 when puncturing the side hole needle. probability; at the same time, it can also play a role in isolating the possible chips of the inner plug 2, that is, the chips of the inner plug 2 are stored between the barrier film 4 and the inner plug 2, so as to prevent or minimize the possibility of the chips of the inner plug 2 entering the liquid. probability.
  • the clearance distance is ⁇ 4.5mm. Specifically, when the clearance distance is greater than or equal to 4.5 mm, the side hole puncture needle can have enough room to avoid, and the inner plug 2 is less likely to snap during the puncture process, thereby reducing the debris generated by the cutting of the inner plug 2 of the side hole puncture needle.
  • the bottom of the inner plug 2 is provided with a first inner spherical surface 21 that is concave upward and arranged centrally.
  • the inner pressing edge 3 is provided with a first inner spherical surface 21 formed by hot pressing and pressed against The pressing boss 31.
  • the first inner spherical surface 21 reduces the puncture distance when the puncture needle punctures the inner plug 2, reduces the difficulty of puncture, and increases the avoidance distance to prevent or minimize the generation of chips of the inner plug 2 during puncture, and then through the pressing protrusion
  • the platform 31 is pressed against the first inner spherical surface 21 to achieve stable support for the inner plug 2 .
  • the pressing boss 31 is formed by hot pressing. Therefore, the pressing boss 31 hugs the first inner spherical surface 21 during the hot pressing process, and the reliability is high.
  • a mounting protrusion 22 protrudes downward at the corner between the lower end surface of the inner plug 2 and the first inner spherical surface 21, and the upper end surface of the inner pressure edge 3 has a mounting protrusion 22 for passing heat.
  • the embedding groove 32 is formed by pressing and is in a concave and convex shape and is inlaid with the mounting protrusion 22 .
  • the mounting protrusion 22 is embedded through the embedding groove 32 to prevent the inner plug 2 from moving radially, thereby ensuring the stability of the inner plug 2 when the puncture needle is punctured, and achieving stable support for the inner plug 2 .
  • the embedding groove 32 is formed by hot pressing. Therefore, the embedding groove 32 hugs the mounting protrusion 22 during the hot pressing process, and the reliability is high.
  • the outer cover 1 includes two puncture cavities 11 respectively used for infusion and dispensing.
  • the puncture cavities 11 and the inner plug 2 are arranged in one-to-one correspondence.
  • the inner stopper 2 for dispensing and the inner stopper 2 for infusion are installed in the two puncture cavities 11 respectively, so as to make the dispensing and infusion convenient and safe and avoid the contamination of the medicinal solution.
  • the size of the inner plug 2 used for infusion is larger than the size of the inner plug 2 used for dispensing, so as to facilitate medical staff to distinguish when using. It should be understood that a steel needle can be used for dispensing medicine, but a plastic needle may be used for infusion.
  • the size of the inner stopper 2 for infusion needs to be larger than the size of the inner stopper 2 for dispensing.
  • the size range of the inner plug 2 used for infusion is ⁇ 9mm.
  • the size range of the inner stopper 2 used for dispensing is ⁇ 3mm.
  • the inner plug 2 used for infusion and the inner plug 2 used for dispensing adopt different colors respectively, so as to facilitate medical staff to distinguish when using.
  • the film cover also includes an easy-to-break cap 5 sealingly connected to the top of the puncture chamber 11 for being folded off to expose the inner plug 2 .
  • the easy-folding cap 5 seals the top of the puncture cavity 11 to prevent the inner plug 2 from being contaminated by the external environment. When used again, the easy-folding cap 5 is folded off to expose the inner plug 2, which facilitates puncture needle puncture.
  • the covering cover further includes a pull ring sealingly connected to the top of the puncture chamber 11 .
  • a puncture hole for matching the puncture needle is opened on the top of the puncture chamber 11, and the easy-breaking cap 5 covers the puncture hole to seal the top of the puncture chamber 11.
  • the diameter range of the puncture hole is 5.3-5.6mm. Specifically, when the diameter of the puncture hole is between 5.3-5.6 mm, the puncture hole matches the size of the puncture needle, which facilitates the infusion operation.
  • the top of the outer cover 1 is provided with an upwardly protruding puncture portion 12 , and the bottom of the puncture portion 12 is concave upward to form a puncture cavity 11 .
  • the puncture cavity 11 is formed by the puncture part 12, and the puncture part 12 protrudes upward to guide the puncture needle to facilitate the puncture and infusion operation.
  • the barrier film 4 is a multi-layer co-extruded film, and the multi-layer co-extruded film is provided with 2-5 layers.
  • the thickness of the barrier film 4 ranges from 0.18 to 0.50 mm.
  • the multi-layer co-extruded film has strong barrier properties, can be oxygen-proof, waterproof, and moisture-proof, has strong mechanical properties, high blast resistance, strong puncture resistance and tear resistance, high temperature resistance, low temperature resistance, oil resistance, and good fragrance retention. It is non-toxic and odorless, has good heat sealing performance, is soft and highly transparent, has high composite peel strength and strong environmental resistance.
  • the multi-layer co-extruded film is not prone to puncture and explosion after being applied.
  • the film thickness is uniform and is not prone to puncture and needle blocking. During puncture, the insoluble particles on the surface of the side hole puncture needle can be blocked out, effectively preventing the possibility of the side hole puncture needle carrying insoluble particles into the infusion solution.
  • the elasticity of the multi-layer co-extruded film is used to form the elastic vibration force when the side hole puncture needle punctures the multi-layer co-extruded film, so that the debris on the surface of the side hole puncture needle can pass through the side hole puncture needle during the multi-layer co-extruded film.
  • the hole part and the surface of the needle body are separated and blocked by the multi-layer co-extruded film, reducing or even eliminating puncture debris.
  • the lower end surface of the inner pressure edge 3 is thermally welded or ultrasonic welded to the multi-layer co-extruded film.
  • the characteristics of the multi-layer co-extruded film blow molding production process determine the uniformity, accuracy and stability of the quality control of the production process.
  • the injection molding process has been repeatedly adapted and verified, and the use of multi-layer co-extruded films for infusion can basically eliminate or minimize the chance of debris falling during puncture; it can also reduce insoluble particles in the infusion solution to ensure the safety of the infusion.
  • the multi-layer co-extruded film is provided with two to five layers, and the thickness of the multi-layer co-extruded film is 0.18-0.5mm.
  • the outer cover 1 is cylindrical, and the outer corner of the outer cover 1 is chamfered. Specifically, chamfering reduces mutual friction between assembly machines or trimming machines during the assembly process of the outer cover 1 and reduces the probability of debris generation, thereby reducing debris generated during the assembly process and reducing film coating after assembly. Debris on the inner and outer surfaces of the cover.
  • the top of the inner plug 2 is provided with a second inner spherical surface 23 that is concave downward and arranged centrally.
  • the second inner spherical surface 23 reduces the puncture distance when the puncture needle punctures the inner plug 2 and reduces the difficulty of puncture.
  • the infusion container of this embodiment includes the above-mentioned inner cover-less film cover for an infusion container. Specifically, by adopting the above-mentioned inner-capless film-covered cover for an infusion container, the manufacturing cost of the infusion container is reduced, and the infusion container is highly practical and easy to promote and use.

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Abstract

一种输液容器用无内盖式覆膜盖以及输液容器，包括外盖（1），外盖（1）包括穿刺腔（11），穿刺腔（11）内布设有内塞（2），穿刺腔（11）的顶部密封，穿刺腔（11）的底部设有弯折成型的用于通过热压弯折成型以抵紧固定内塞（2）的内压边（3），覆膜盖还包括覆盖于内压边（3）的下端面上的用于密封穿刺腔（11）的底部的阻隔膜（4），这种结构大大降低输液容器盖的制造成本，且阻隔膜（4）相对于内盖穿刺难度低，便于医护人员使用。

Description

输液容器用无内盖式覆膜盖及输液容器 技术领域
本发明涉及医药包装技术领域，特别地，涉及一种输液容器用无内盖式覆膜盖。此外，本发明还涉及一种包括上述输液容器用无内盖式覆膜盖的输液容器。
背景技术
目前，常见的输液容器盖一般为组合式结构，其主要包括外盖、内塞和内盖，外盖容纳内塞，内盖布设于外盖内以起到固定内塞的作用，使得针管穿刺内塞输液时整体结构不会发生松脱，同时还防止内塞与药液接触，内塞主要避免内盖被针管穿刺后药液渗出输液容器外。
然而，由于内盖需要固定内塞，防止内塞松脱，对其强度有一定要求，同时还需要避免被针管穿刺后不破裂，对其韧性有一定要求，同时内盖与药液直接接触，对其材料的特殊性有一定要求，基于以上要求，导致内盖的材料成本较为昂贵，提高了输液容器盖的整体制造成本。
发明内容
本发明提供了一种输液容器用无内盖式覆膜盖及输液容器，以解决现有的输液容器盖由于内盖的材料成本昂贵，导致输液容器盖的制造成本高的技术问题。
根据本发明的一个方面，提供一种输液容器用无内盖式覆膜盖，包括外盖，外盖包括穿刺腔，穿刺腔内布设有内塞，穿刺腔的顶部密封，穿刺腔的底部设有弯折成型的用于通过热压弯折成型以抵紧固定内塞的内压边，覆膜盖还包括覆盖于内压边的下端面上的用于密封穿刺腔的底部的阻隔膜。
作为上述技术方案的进一步改进：
进一步地，内压边和外盖之间凹设有用于便于内压边热压时定长度和弯折成型的折弯凹角。
进一步地，内压边和外盖之间的凹设有折弯凹角的转角处的厚度范围为0.4-0.8mm。
进一步地，内压边的内侧面与内压边的下端面之间的转角处设有倒角。
进一步地，内压边的厚度范围为1.0-2.0mm。
进一步地，阻隔膜和内塞的待穿刺部位之间留有用于侧孔穿刺针接触阻隔膜的待穿刺部位时侧孔穿刺针的侧孔部位完全脱离内塞的净空距离。
进一步地，净空距离≥4.5mm。
进一步地，内塞的底部向上凹设有居中布设的第一内球面，内压边设有向上凸起的用于抵紧第一内球面的抵紧凸台。
进一步地，内塞的下端面与第一内球面之间的转角处向下凸设有安装凸起，内压边的上端面凹设有与安装凸起对应布设的用于嵌固安装凸起的嵌固凹槽。
根据本发明的另一方面，还提供了一种输液容器，其包括上述的输液容器用无内盖式覆膜盖。
本发明具有以下有益效果：
本发明的输液容器用无内盖式覆膜盖，首先通过注塑工艺获得具有穿刺腔的外盖，以将内塞塞入穿刺腔内，穿刺腔的顶部呈密封状态，避免内塞与外界环境接触而污染，内压边和外盖采用注塑工艺一体成型且注塑时外盖轴向延伸形成未弯折的内压边，然后通过热压工艺使内压边朝向内塞方向折弯，且内压边在热压折弯过程中基体密实度增加，基体强度、表面光滑度增加，弯折成型的内压边完全贴紧和包覆于内塞表面，可靠性高，最后通过焊接工艺将阻隔膜焊接覆盖在内压边的下端面上，以密封穿刺腔的底部，避免输液容器内的药液与内塞接触而污染，同时阻隔膜还可防止穿刺针穿刺产生的内塞落屑落入药液内，本方案通过外盖容纳内塞，再通过内压边和阻隔膜协同配合，以固定和密封内塞，相对于现有技术，在实现固定密封内塞的基础上，通过内压边和阻隔膜共同作用以取代材料要求高、价格较为昂贵的内盖，大大降低输液容器盖的制造成本，且阻隔膜相对于内盖穿刺难度低，便于医护人员使用，实用性强，适于广泛推广和应用。
除了上面所描述的目的、特征和优点之外，本发明还有其它的目的、特征和优点。下面将参照图，对本发明作进一步详细的说明。
附图说明
构成本申请的一部分的附图用来提供对本发明的进一步理解，本发明的示意性实施例及其说明用于解释本发明，并不构成对本发明的不当限定。在附图中：
图1是本发明优选实施例的输液容器用无内盖式覆膜盖的结构示意图；
图2是本发明优选实施例的输液容器用无内盖式覆膜盖的剖面示意图。
图例说明：
1、外盖；11、穿刺腔；12、穿刺部；2、内塞；21、第一内球面；22、安装凸起；23、第二内球面；3、内压边；31、抵紧凸台；32、嵌固凹槽；33、折弯凹角；4、阻隔膜；5、易折帽。
具体实施方式
以下结合附图对本发明的实施例进行详细说明，但是本发明可以由下述所限定和覆盖的多种不同方式实施。
图1是本发明优选实施例的输液容器用无内盖式覆膜盖的结构示意图；图2是本发明优选实施例的输液容器用无内盖式覆膜盖的剖面示意图。
如图1和图2所示，本实施例的输液容器用无内盖式覆膜盖，包括外盖1，外盖1包括穿刺腔11，穿刺腔11内布设有内塞2，穿刺腔11的顶部密封，穿刺腔11的底部设有用于通过热压弯折成型以抵紧固定内塞2的内压边3，内压边3的下端面上还附着有用于密封穿刺腔11的底部的阻隔膜4。具体地，本发明的输液容器用无内盖式覆膜盖，首先通过注塑工艺获得具有穿刺腔11的外盖1，以将内塞2塞入穿刺腔11内，穿刺腔11的顶部呈密封状态，避免内塞2与外界环境接触而污染，内压边3和外盖1采用注塑工艺一体成型且注塑时外盖1轴向延伸形成未弯折的内压边3，然后通过热压工艺使内压边3朝向内塞2方向折弯，且内压边3在热压折弯过程中基体密实度增加，基体强度、表面光滑度增加，弯折成型的内压边3完全贴紧和包覆于内塞2表面，可靠性高，最后通过焊接工艺将阻隔膜4焊接覆盖在内压边3的下端面上，以密封穿刺腔11的底部，避免输液容器内的药液与内塞2接触而污染，同时阻隔膜4还可防止穿刺针穿刺产生的内塞2落屑落入药液内，本方案通过外盖1容纳内塞2，再通过内压边3和阻隔膜4协同配合，以固定和密封内塞2，相对于现有技术，在实现固定密封内塞2的基础上，通过内压边3和阻隔膜4共同作用以取代材料要求高、价格较为昂贵的内盖，大大降低输液容器盖的制造成本，且阻隔膜4相对于内盖穿刺难度低，便于医护人员使用，实用性强，适于广泛推广和应用。可选地，内塞2采用具备一定弹性的硅胶制成。
本实施例中，内压边3和外盖1之间凹设有用于便于内压边3热压时定长度和弯折成型的折弯凹角33。具体地，折弯凹角33的设置，内压边3热压时易于弯折，以保证内压边3弯折成型后下端面的水平，进而提高焊接覆盖阻隔膜4后的密封性，且弯折长度易取决于折弯凹角33的位置，使得内压边3各个尺寸相对固定，便于注塑成型。应当理解的是，折弯凹角33部分基体厚度薄，经过热压，在折弯凹角33位置一定程度进行了局部焊合和加强，进而提高了折弯部位的承载力。
本实施例中，内压边3和外盖1之间的凹设有折弯凹角33的转角处的厚度范围为0.3-1.0mm。具体地，当内压边3和外盖1之间的凹设有折弯凹角33的转角处的厚度处于0.3-1.0mm之间时，内压边3易于弯折，且内压边3和外盖1之间的凹设有折弯凹角33的转角处的强度有保证；当内压边3和外盖1之间的凹设有折弯凹角33的转角处的厚度小于0.3mm时，内压边3和外盖1之间的凹设有折弯凹角33的转角处强度无法保证，容易热压时或者使用过程中断裂；当内压边3和外盖1之间的凹设有折弯凹角33的转角处的厚度大于1.0mm时，内压边3不易弯折。优选地，内压边3和外盖1之间的凹设有折弯凹角33的转角处的厚度范围为0.4-0.8mm。
如图2所示，本实施例中，内压边3的自由端的远离内塞2的一侧转角处设置为倒角。具体地，通过倒角内压边3的自由端的远离内塞2的一侧转角处的用材，便于内压边3通过热压向上弯折成型。
本实施例中，内压边3的厚度范围为0.8-3.0mm。具体地，当内压边3的厚度处于0.8-3.0mm 之间时，内压边3的强度可靠，实现对内塞2的稳定支撑，同时便于热压时弯折成型；当内压边3的厚度小于0.8mm时，内压边3的强度无法保证，可能无法在穿刺针穿刺时实现对内塞2的稳定支撑；当内压边3的厚度大于3.0mm时，内压边3弯折时的内应力过大，易在折弯处断裂，弯折难度大。应当理解的是，由于穿刺针穿刺内塞2时，其压力主要由内压边3承担，因此，需要严格保证内压边3的厚度尺寸，以保证支撑可靠。应当理解的是，本申请由于折弯凹角33的布设，即使内压边3的厚度适当增大，也可实现弯折。优选地，内压边3的厚度范围为1.0-2.0mm。
如图2所示，本实施例中，阻隔膜4和内塞2的待穿刺部位之间留有用于侧孔穿刺针接触阻隔膜4的待穿刺部位时侧孔穿刺针的侧孔部位完全脱离内塞2的净空距离。具体地，通过净空距离，使得侧孔穿刺针穿刺阻隔膜4时侧孔穿刺针的侧孔完全脱离内塞2内部，以有效避免穿刺针穿刺阻隔膜4时由小到最大到最小的穿刺切削力，进而杜绝侧孔穿刺针穿刺产生的内塞2落屑和最大限度减少内塞2产生落屑的几率；且净空距离还可有效确保内塞2部过于压实，消除内塞2受压的内应力，给予穿刺时内塞2相对自由伸展空间，充分防止内塞2本身的弹性作用，最大程度减少穿刺时产生的切削阻力，以杜绝或最大限度减少侧孔针穿刺时内塞2落屑产生的几率；同时也可对可能产生的内塞2落屑起到隔离的作用，即将内塞2落屑收纳于阻隔膜4和内塞2之间，以杜绝或最大限度减少内塞2落屑进入药液的几率。
本实施例中，净空距离≥4.5mm。具体地，当净空距离大于或者等于4.5mm时，可使得侧孔穿刺针有足够的避让空间，穿刺过程中内塞2不易蹦紧，从而减少侧孔穿刺针对内塞2切削产生的碎屑。
如图2所示，本实施例中，内塞2的底部设有向上凹设并居中布设的第一内球面21，内压边3设有用于通过热压形成并抵紧第一内球面21的抵紧凸台31。具体地，通过第一内球面21减少穿刺针穿刺内塞2时的穿刺距离，降低穿刺难度，同时增大避空距离，杜绝或者最大程度减少穿刺时产生内塞2落屑，再通过抵紧凸台31抵紧第一内球面21，实现对内塞2的稳定支撑。应当理解的是，抵紧凸台31通过热压形成，因此，热压过程中抵紧凸台31抱紧第一内球面21，可靠性高。
如图2所示，本实施例中，内塞2的下端面与第一内球面21之间的转角处向下凸设有安装凸起22，内压边3的上端面设有用于通过热压形成的呈凹凸状的并与安装凸起22嵌固配合的嵌固凹槽32。具体地，通过嵌固凹槽32嵌固安装凸起22，以避免内塞2径向移动，进而保证穿刺针穿刺时内塞2的稳定，实现对内塞2的稳定支撑。应当理解的是，嵌固凹槽32通过热压形成，因此，热压过程中嵌固凹槽32抱紧安装凸起22，可靠性高。
如图2所示，本实施例中，外盖1包括分别用于输液和配药的两个穿刺腔11，穿刺腔11与内塞2一一对应布设。具体地，将配药的内塞2和输液的内塞2分别安装在两个穿刺腔11内，以使配药及输液方便、安全，避免药液受到污染。可选地，用于输液的内塞2尺寸大于用于配药的内塞2尺寸，以便于医护人员使用时区分。应当理解的是，配药时可采用钢针配药，而输液时可能需要采用塑料针输液，因此，输液的内塞2尺寸需大于配药的内塞2尺寸。可选地，用于输液的内塞2尺寸范围为≥9mm。可选地，用于配药的内塞2尺寸范围为≥3mm。可选地，用于输液的内塞2和用于配药的内塞2分别采用不同的颜色，以便于医护人员使用 时区分。如图2所示，本实施例中，覆膜盖还包括密封连接于穿刺腔11的顶部的用于折去后露出内塞2的易折帽5。具体地，易折帽5密封穿刺腔11的顶部，避免内塞2受外界环境的污染，再使用时，折去易折帽5，即可露出内塞2，便于穿刺针穿刺。可选地，另一实施例中，覆膜盖还包括密封连接于穿刺腔11的顶部的拉环。
如图2所示，本实施例中，穿刺腔11的顶部开设有用于与穿刺针匹配的穿刺孔，易折帽5覆盖于穿刺孔上以密封穿刺腔11的顶部，穿刺孔的直径范围为5.3-5.6mm。具体地，当穿刺孔的直径处于5.3-5.6mm之间时，穿刺孔与穿刺针的大小相匹配，便于进行输液操作。
如图1和图2所示，本实施例中，外盖1的顶部设有向上凸起的穿刺部12，穿刺部12的底部向上内凹形成穿刺腔11。具体地，通过穿刺部12形成穿刺腔11，且由于穿刺部12向上凸起，以对穿刺针进行导向，便于进行穿刺输液操作。
本实施例中，阻隔膜4为多层共挤膜，多层共挤膜布设有2-5层，阻隔膜4的厚度范围为0.18-0.50mm。具体地，多层共挤膜具有阻隔性强，可以防氧、防水、防潮，机械性能强，抗爆破性能高，抗穿刺抗撕裂性能强，耐高温、低温，耐油、保香性好，无毒无味，热封性能好，柔软高透，复合剥离强度高、耐环境性强等特点，多层共挤膜贴膜后不容易出现穿刺炸裂，薄膜厚度均匀，不容易出现穿刺堵针现象，穿刺时能够将侧孔穿刺针表面的不溶性微粒阻隔在外，有效防止侧孔穿刺针携带不溶性微粒进入输液溶液的几率。利用多层共挤膜的弹性，形成侧孔穿刺针穿刺多层共挤膜时的弹性振动力，使得侧孔穿刺针表面的碎屑在多层共挤膜时能够从而侧孔穿刺针的侧孔部位以及针体表面脱离，并被多层共挤膜阻隔于外，减少甚至消除穿刺落屑。内压边3的下端面上通过热焊接或超声波焊接多层共挤膜，多层共挤膜吹塑生产工艺特性，决定了其生产过程质量控制的均一性、精准性、稳定性远高于注塑成型工艺，反复适应及验证证明，采用输液用多层共挤膜，可基本杜绝或最大限度减少穿刺时落屑的几率；消减输液溶液内的不溶性微粒，以保证输液的安全。同时，多层共挤膜设置有二层至五层，多层共挤膜的厚度为0.18-0.5mm。能够减小侧孔穿刺针对多层共挤膜的切削，从而减少穿刺落屑；形成对侧孔穿刺针的多层抱紧和阻隔，从而将侧孔穿刺针表面的碎屑能够完全被阻隔，减少甚至消除穿刺落屑。
如图1所示，本实施例中，外盖1为圆柱形，外盖1的外圆侧转角处设有倒角。具体地，通过倒角使得外盖1在装配过程中，减少装配机械或修整机械之间的相互摩擦，减少碎屑产生的几率，从而减少装配过程中产生的碎屑，减少装配后的覆膜盖内外表面的碎屑。
如图2所示，本实施例中，内塞2的顶部设有向下凹设并居中布设的第二内球面23。具体地，通过第二内球面23减少穿刺针穿刺内塞2时的穿刺距离，降低穿刺难度。
本实施例的输液容器，包括上述的输液容器用无内盖式覆膜盖。具体地，通过采用上述的输液容器用无内盖式覆膜盖，以降低输液容器的制造成本，实用性强，便于推广使用。
以上所述仅为本发明的优选实施例而已，并不用于限制本发明，对于本领域的技术人员来说，本发明可以有各种更改和变化。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (10)

  1. 一种输液容器用无内盖式覆膜盖，包括外盖(1)，外盖(1)包括穿刺腔(11)，穿刺腔(11)内布设有内塞(2)，其特征在于，穿刺腔(11)的顶部密封，穿刺腔(11)的底部设有用于通过热压弯折成型以抵紧固定内塞(2)的内压边(3)，内压边(3)的下端面上还附着有用于密封穿刺腔(11)的底部的阻隔膜(4)。
  2. 根据权利要求1所述的输液容器用无内盖式覆膜盖，其特征在于，内压边(3)和外盖(1)之间凹设有用于便于内压边热压时定长度和弯折成型的折弯凹角(33)。
  3. 根据权利要求2所述的输液容器用无内盖式覆膜盖，其特征在于，内压边(3)和外盖(1)之间的凹设有折弯凹角(33)的转角处的厚度范围为0.3-1.0mm。
  4. 根据权利要求1所述的输液容器用无内盖式覆膜盖，其特征在于，内压边(3)的自由端的远离内塞(2)的一侧设置为倒角。
  5. 根据权利要求1所述的输液容器用无内盖式覆膜盖，其特征在于，内压边(3)的厚度范围为0.8-3.0mm。
  6. 根据权利要求1所述的输液容器用无内盖式覆膜盖，其特征在于，阻隔膜(4)和内塞(2)的待穿刺部位之间留有用于侧孔穿刺针接触阻隔膜(4)的待穿刺部位时侧孔穿刺针的侧孔部位完全脱离内塞(2)的净空距离。
  7. 根据权利要求6所述的输液容器用无内盖式覆膜盖，其特征在于，净空距离≥4.5mm。
  8. 根据权利要求1所述的输液容器用无内盖式覆膜盖，其特征在于，内塞(2)的底部设于向上凹设并居中布设的第一内球面(21)，内压边(3)设有用于通过热压形成并抵紧第一内球面(21)的抵紧凸台(31)。
  9. 根据权利要求8所述的输液容器用无内盖式覆膜盖，其特征在于，外盖(1)包括分别用于输液和配药的两个穿刺腔(11)，穿刺腔(11)与内塞(2)一一对应布设。
  10. 一种输液容器，其特征在于，包括权利要求1所述的输液容器用无内盖式覆膜盖。
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