WO2024021332A1 - 输液容器用无外盖式覆膜盖及输液容器 - Google Patents

输液容器用无外盖式覆膜盖及输液容器 Download PDF

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Publication number
WO2024021332A1
WO2024021332A1 PCT/CN2022/127541 CN2022127541W WO2024021332A1 WO 2024021332 A1 WO2024021332 A1 WO 2024021332A1 CN 2022127541 W CN2022127541 W CN 2022127541W WO 2024021332 A1 WO2024021332 A1 WO 2024021332A1
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Prior art keywords
puncture
cover
inner plug
film
infusion
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PCT/CN2022/127541
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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
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Hunan China Sun Pharmaceutical Machinery Co Ltd
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Hunan China Sun Pharmaceutical Machinery Co Ltd
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Publication of WO2024021332A1 publication Critical patent/WO2024021332A1/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 overall structure of the inner plug will not loosen during infusion, and it 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 outer cover usually has a pull ring to pull it apart. Cover the outside to reveal the inner plug.
  • the outer cover cannot be damaged before use, and the pull ring cannot be broken during use, but the center part of the outer cover must be broken to expose the inner plug.
  • the above requirements must be met to ensure that the outer cover is The material requirements are high, which makes the material cost of the inner cover relatively expensive, which increases the overall manufacturing cost of the infusion container cover.
  • the inner plug mostly uses a rubber inner plug.
  • the main component of the rubber inner plug is synthetic rubber, which also contains sulfur, zinc oxide, carbon ink, talcum powder, etc. These impurities are easy to fall off and form insoluble particles;
  • the rubber inner plug has side holes. The side hole puncture needle and the oblique puncture needle will penetrate the inner plug and the inner cover in sequence during the puncture process.
  • the side hole needle or the oblique hole needle will carry the insoluble particles generated by the inner plug and the inner cover into the infusion solution, causing the infusion solution to leak. Increased insoluble particles.
  • the clinical use of traditional products shows that almost all side-hole needles produce internal plugging debris during puncture, and oblique-hole needles almost all produce inner cover plastic debris.
  • the invention provides a non-covered film cover for an infusion container and an infusion container to solve the problem that the manufacturing cost of the infusion container cover is high due to the expensive material cost of the outer cover of the existing infusion container cover, and at the same time, it is easy for the puncture needle to
  • the technical problem is that the insoluble particles produced by the inner plug and inner cover are substituted into the medicinal solution.
  • a coverless cover for an infusion container which includes an inner cover.
  • the inner cover includes a puncture cavity.
  • An inner plug is arranged in the puncture cavity.
  • the inner cover also includes a plug arranged at the bottom of the puncture cavity.
  • a barrier tube used to seal the bottom of the puncture chamber.
  • the side hole part of the side hole puncture needle is completely To break away from the clearance distance of the inner plug, the top of the puncture cavity is provided with an outer pressure edge that is bent and molded by hot pressing to hold the inner plug in place.
  • the upper end of the outer pressure edge is also attached with a seal for sealing the puncture cavity.
  • the easy-to-tear film on the top has two puncture cavities, which are used for infusion and dispensing respectively.
  • the puncture cavities, inner plugs, barrier tubes and outer pressure edges are arranged in one-to-one correspondence.
  • the thickness of the portion to be punctured at the bottom of the barrier tube ranges from 0.30 to 0.50 mm.
  • the upper end surface of the outer pressing edge is provided with a welding protrusion convexly upward
  • the lower end surface of the easy-to-tear film is concavely provided with a welding groove for welding connection with the welding protrusion.
  • the edge of the easy-tearing film is provided with an easy-tearing edge formed by bending downward.
  • the clearance distance is ⁇ 4.5mm.
  • the top of the inner plug is provided with a first inner spherical surface that is concave downward and arranged centrally, and the outer pressing edge is provided with a pressing boss for forming by hot pressing and pressing against the first inner spherical surface.
  • a first mounting protrusion that abuts the outer annular surface of the pressing boss is protruded upward from the corner between the upper end surface of the inner plug and the first inner spherical surface.
  • the bottom of the inner plug is provided with a second inner spherical surface that is concave upward and arranged centrally.
  • the upper end surface of the barrier tube is in close contact with the lower end surface of the inner plug, and a second mounting protrusion is protruded downward at the corner between the lower end surface of the inner plug and the second inner spherical surface to contact the inner wall surface of the barrier cylinder. rise.
  • an infusion container which includes the above-mentioned coverless cover for an infusion container.
  • the infusion container of the present invention uses a non-covered film cover.
  • an inner cover with two puncture cavities is obtained through an injection molding process, and then the inner plug for dispensing and the inner plug for infusion are inserted into two independent cavities that are isolated from each other.
  • the puncture cavity it makes dispensing and infusion convenient and safe, and avoids contamination of the medicinal solution.
  • the bottom of the puncture cavity is sealed by a barrier cylinder.
  • the barrier cylinder is designed with a sinking structure in the inner cavity of the non-covered film cover to avoid the infusion container.
  • the liquid inside is contaminated due to contact with the inner plug, and the clearance distance allows the side hole puncture needle to completely separate from the inner plug when the side hole puncture needle penetrates the site to be punctured at the bottom of the barrier tube, thereby effectively avoiding side hole puncture.
  • the puncture cutting force is increased from small to maximum to minimum, thereby eliminating the chipping of the inner plug caused by the needle puncture of the side hole or minimizing the chance of chipping of the inner plug.
  • the outer holder and the inner cover are integrally formed using an injection molding process.
  • the inner cover is axially extended to form an unbent outer edge, and then the outer edge is bent toward the inner plug through a hot pressing process, and the matrix density of the outer edge increases during the hot pressing and bending process, and the strength of the matrix increases. , the surface smoothness is increased, the bent outer pressure edge is completely close to and covering the surface of the inner plug, and finally the easy-tearing film is welded and covered on the upper end surface of the outer pressure edge through a welding process to seal the top of the puncture cavity to avoid The inner plug is contaminated due to contact with the external environment.
  • This solution uses the inner cover, outer pressure edge and easy-tear film to cooperate with each other to achieve the fixation and sealing of the inner plug, and the setting of the barrier tube and two puncture cavities, side hole puncture
  • the needle is not prone to puncture chips, and dispensing and infusion can be performed separately to eliminate or eliminate to the greatest extent the possibility of contamination of the inner plug by the external environment and contamination of the medicinal solution.
  • the external pressure edge and the easy-tear film work together to replace the outer cover with high material requirements and relatively expensive price, which greatly reduces the manufacturing cost of the infusion container cover.
  • the easy-tear film is less difficult to open than the outer cover, making it easier for medical staff to use. , highly practical and suitable for widespread promotion and application.
  • Figure 1 is a schematic structural diagram of a coverless 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 a coverless film-covered cover for an infusion container according to a preferred embodiment of the present invention.
  • Inner cover 11. Puncture chamber; 12. Barrier tube; 13. Puncture part; 2.
  • Inner plug 21. First inner spherical surface; 22. First mounting protrusion; 23. Second inner spherical surface; 24. 2. Installation protrusion; 3. External pressure edge; 31. Welding protrusion; 32. Holding boss; 4. Easy tearing film; 41. Easy tearing edge.
  • Figure 1 is a schematic structural diagram of a coverless film cover for an infusion container according to a preferred embodiment of the present invention
  • Figure 2 is a schematic cross-sectional view of a coverless film cover for an infusion container according to a preferred embodiment of the present invention.
  • the infusion container of this embodiment uses a non-covered film cover, including an inner cover 1.
  • the inner cover 1 includes a puncture chamber 11, and an inner plug 2 is arranged in the puncture chamber 11.
  • the inner cover 1 It also includes a barrier tube 12 arranged at the bottom of the puncture chamber 11 for sealing the bottom of the puncture chamber 11. There is a gap between the bottom of the barrier tube 12 and the site to be punctured of the inner plug 2 for the side hole puncture needle to puncture the barrier tube 12.
  • the side hole puncture needle at the bottom is to be punctured, the side hole part is completely separated from the clearance distance of the inner plug 2.
  • the top of the puncture chamber 11 is provided with a bending molding for pressing and fixing the inner plug 2 by bending and molding by hot pressing.
  • the outer pressing edge 3 has an easy-tearing film 4 attached to the upper end surface of the outer pressing edge 3 for sealing the top of the puncture chamber 11.
  • the puncture chamber 11 and the inner plug 2 , the barrier tube 12 and the outer pressure edge 3 are arranged in one-to-one correspondence.
  • the infusion container of the present invention uses a non-covered film cover. First, an inner cover 1 with two puncture cavities 11 is obtained through an injection molding process, and then the inner plug 2 for dispensing and the inner plug 2 for infusion are inserted into the two containers respectively.
  • the puncture chamber 11 is separated into independent cavities, which makes dispensing and infusion convenient and safe, and avoids contamination of the medicinal solution.
  • the bottom of the puncture chamber 11 is sealed by a barrier tube 12, and the barrier tube 12 is in the inner chamber without an outer cover. It has a sunken structure design to avoid contamination caused by contact between the medicinal solution in the infusion container and the inner plug 2, and the clearance distance allows the side hole puncture needle to penetrate the site to be punctured at the bottom of the barrier tube 12.
  • the outer edge 3 and the inner cover 2 are integrally formed using an injection molding process.
  • the inner cover 1 extends axially to form an unbent outer edge 3, and then the outer edge 3 faces the inner plug 2 through a hot pressing process. direction of bending, and the matrix density of the outer edge 3 increases during the hot press bending process, and the strength and surface smoothness of the matrix increase.
  • the bent outer edge 3 is completely attached to and covered with the surface of the inner plug 2, and finally
  • the easy-tearing film 4 is welded and covered on the upper end surface of the outer pressure edge 3 through a welding process to seal the top of the puncture cavity 11 and avoid contamination caused by the contact between the inner plug 2 and the external environment.
  • This solution uses the inner cover 1, the outer pressure edge 3 and The easy-to-tear films 4 cooperate with each other to achieve fixation and sealing of the inner plug 2, and with the arrangement of the blocking tube 12 and the two puncture cavities 11, the side hole puncture needle is less likely to produce puncture chips, and dispensing and infusion can be performed separately, so as to Prevent or eliminate to the greatest extent the probability that the inner plug 2 is contaminated by the external environment and the medicinal liquid.
  • the outer pressure edge 3 and the easy-tearing film 4 work together
  • the function is to replace the outer cover with high material requirements and relatively expensive price, greatly reducing the manufacturing cost of the infusion container cover, and the easy-tear film 4 is less difficult to open than the outer cover, which is convenient for medical staff to use, has strong practicability, and is suitable for widespread promotion and application.
  • the inner plug 2 is made of silicone with certain elasticity.
  • the clearance distance can effectively ensure that the inner plug 2 is not too compacted, eliminates the internal stress of the inner plug 2 under pressure, gives the inner plug 2 a relatively free space to expand during puncture, and gives full play to the elasticity of the inner plug 2 itself. Minimize the cutting resistance generated by the puncture needle, thereby eliminating or minimizing the probability of chipping of the inner plug 2 produced by the puncture needle of the side hole.
  • the clearance distance can also isolate the debris generated by the inner plug 2 during puncture, and is blocked between the blocking cylinder 12 and the inner plug 2, thereby preventing or minimizing the possibility of the debris from the inner plug 2 entering the medicinal solution. probability.
  • 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.
  • a steel needle can be used for dispensing medicine, but a plastic needle may be used for infusion. Therefore, 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 are respectively in different colors to facilitate medical staff to distinguish them when using.
  • the thickness of the portion to be punctured at the bottom of the barrier tube 12 ranges from 0.30 to 0.50 mm. Specifically, when the thickness of the portion to be punctured at the bottom of the barrier tube 12 is between 0.30-0.50 mm, the strength of the portion to be punctured at the bottom of the barrier tube 12 is appropriate, the difficulty of puncture is low, and the puncture needle is not easy to break when punctured. Plug 2 chips fall into the liquid; when the thickness of the part to be punctured at the bottom of the barrier tube 12 is less than 0.30mm, it is easy to be burned through during the injection molding process. The strength of the part to be punctured at the bottom of the barrier tube 12 is too low, and the puncture needle will puncture.
  • the thickness of the portion to be punctured at the bottom of the barrier tube 12 ranges from 0.39 to 0.45 mm.
  • the upper end surface of the outer pressure edge 3 is provided with a welding protrusion 31 convex upward, and the lower end surface of the easy-tear film 4 is recessed with a welding groove for welding connection with the welding protrusion 31 .
  • the easy-tearing film 4 is reliably welded to the upper end surface of the outer edge 3 through the welding groove and the welding protrusion 31 .
  • the edge of the easy-tear film 4 is provided with an easy-tear edge 41 formed by bending downward.
  • the easy-tear edge 41 facilitates medical staff to tear open the easy-tear film 4 to expose the inner plug 2 .
  • the easy-tearing edge 41 is provided with anti-skid patterns for increasing friction, and the anti-skid patterns have a concave-convex structure.
  • 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 top of the inner plug 2 is provided with a first inner spherical surface 21 that is concave downward and arranged centrally.
  • the pressing boss 32 of the spherical surface 21 is used to reduce the puncture distance when the puncture needle pierces the inner plug 2 and the difficulty of puncture is reduced, and then the pressing boss 32 is pressed against the first inner spherical surface 21 to achieve stable fixation of the inner plug 2 .
  • the pressing boss 32 is formed by hot pressing. Therefore, the pressing boss 32 hugs the first inner spherical surface 21 during the hot pressing process, and the reliability is high.
  • a first mounting protrusion is protruded upward at the corner between the upper end surface of the inner plug 2 and the first inner spherical surface 21 to abut against the outer annular surface of the pressing boss 32 . twenty two. Specifically, the first mounting protrusion 22 abuts the outer ring surface of the abutment boss 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 fixation of the inner plug 2 .
  • the bottom of the inner plug 2 is concave upward with a second inner spherical surface 23 arranged centrally.
  • the second inner spherical surface 23 reduces the puncture distance when the puncture needle pierces 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.
  • the upper end surface of the blocking tube 12 is in close contact with the lower end surface of the inner plug 2 , and a downwardly protruding groove is formed at the corner between the lower end surface of the inner plug 2 and the second inner spherical surface 23 .
  • the second mounting protrusion 24 is in contact with the inner wall surface of the barrier tube 12 .
  • the inner wall surface of the blocking tube 12 is in contact with the second mounting protrusion 24 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 .
  • a recessed bending angle is provided between the outer edge 3 and the inner cover 1 to facilitate length determination and bending of the outer edge 3 during hot pressing.
  • the setting of the bending concave angle makes it easy to bend the outer edge 3 during hot pressing to ensure the level of the upper end surface of the outer edge 3 after bending and forming, thereby improving the sealing after welding and covering the barrier film, and the bending length It is easy to depend on the position of the bending concave angle, so that the dimensions of the outer pressure edge 3 are relatively fixed, which is convenient for injection molding.
  • the base thickness of the bending concave corner is thin, and after hot pressing, the bending concave corner 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 outer pressing edge 3 and the inner cover 1 where the bending recessed corner is provided ranges from 0.4 to 0.8 mm. Specifically, when the thickness of the corner between the outer pressure edge 3 and the inner cover 1 where the bending recessed corner is between 0.4-0.8 mm, the outer pressure edge 3 is easy to bend, and the outer pressure edge 3 and the inner pressure edge 3 are easily bent.
  • the strength of the corner between the cover 1 and the concave corner is guaranteed; when the thickness of the corner between the outer pressing edge 3 and the inner cover 1 and the concave bending angle is less than 0.4mm, the outer pressing edge The strength of the corner where the recess between 3 and the inner cover 1 is provided with a recessed bend cannot be guaranteed, and it is easy to break during hot pressing or during use; When the thickness at the corner is greater than 0.8mm, the outer pressing edge 3 is not easy to bend.
  • the side of the free end of the outer pressure edge 3 away from the inner plug 2 is chamfered. Specifically, the material on the side of the free end of the outer edge 3 away from the inner plug 2 is reduced by chamfering, so that the outer edge 3 can be bent downward through hot pressing.
  • the thickness of the outer edge 3 ranges from 1.0 to 2.0 mm. Specifically, when the thickness of the outer edge 3 is between 1.0-2.0mm, the strength of the outer edge 3 is appropriate and it is easy to bend and form during hot pressing; when the thickness of the outer edge 3 is less than 1.0mm, the outer edge 3 The strength of 3 cannot be guaranteed and may break during the hot pressing and bending process, making the bending difficult; when the thickness of the outer edge 3 is greater than 2.0mm, the internal stress during bending of the outer edge 3 is too large, and it is easy to bend during bending. It breaks at various places and is difficult to bend.
  • the outer pressing edge 3 encloses a puncture hole for matching the puncture needle, and the diameter of the puncture hole ranges from 5.3 to 5.6 mm. 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 infusion container of this embodiment includes the above-mentioned non-covered film cover for the infusion container. Specifically, by adopting the above-mentioned non-covered film cover for the infusion container, the manufacturing cost of the infusion container can be reduced, while the inner stopper 2 and the medicinal solution can be prevented from being contaminated.
  • the invention has strong practicability and is easy to promote and use.

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Abstract

一种输液容器用无外盖式覆膜盖及输液容器，包括内盖（1），内盖（1）包括穿刺腔（11），穿刺腔（11）内布设有内塞（2），内盖（1）还包括布设于穿刺腔（11）的底部的用于密封穿刺腔（11）的底部的阻隔筒（12），阻隔筒（12）的底部和内塞（2）的待穿刺部位之间留有用于侧孔穿刺针穿刺阻隔筒（12）的底部的待穿刺部位时、侧孔穿刺针的侧孔部位完全脱离内塞（2）的净空距离，穿刺腔（11）的顶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）的外压边（3），外压边（3）的上端面上还附着有用于密封穿刺腔（11）的顶部的易撕膜（4），穿刺腔（11）有两个并分别用于输液和配药，穿刺腔（11）、内塞（2）、阻隔筒（12）和外压边（3）一一对应布设。

Description

输液容器用无外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，外盖上通常具有拉环来拉开外盖以露出内塞。
然而，由于输液产品的特殊性，外盖在使用前不能被损害，拉环在使用时不能被拉断，但必须将外盖中心部分拉破以露出内塞，要满足上述要求使得外盖的材料要求高，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。
同时，随着产品设计、注塑制造、药品生产工艺摩擦、临床使用穿刺针切割等方法的不同，以及传统产品结构设计的不合理，经反复试验、验证，证明其产生的微粒污染程度也不同；其次，内塞多采用橡内塞，橡内塞主要成分为合成橡胶，还包含有硫、氧化锌、碳墨、滑石粉等，这些杂质易脱落，形成不溶性微粒；再次，带有侧孔的侧孔穿刺针和斜口穿刺针在穿刺过程中会依次贯穿内塞和内盖，侧孔针或斜口针会顺势携带内塞和内盖产生的不溶性微粒进入输液溶液，而导致输液溶液的不溶性微粒增多。且传统产品临床使用表现为侧孔针穿刺时基本全部产生内塞屑，斜口针基本全部为内盖塑料屑。
发明内容
本发明提供了一种输液容器用无外盖式覆膜盖及输液容器，以解决现有的输液容器盖由于外盖的材料成本昂贵，导致输液容器盖的制造成本高，同时穿刺针容易将内塞和内盖产生的不溶性微粒代入药液内的技术问题。
根据本发明的一个方面，提供一种输液容器用无外盖式覆膜盖，包括内盖，内盖包括穿刺腔，穿刺腔内布设有内塞，内盖还包括布设于穿刺腔的底部的用于密封穿刺腔的底部的阻隔筒，阻隔筒的底部和内塞的待穿刺部位之间留有用于侧孔穿刺针穿刺阻隔筒的底部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，穿刺腔的顶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外压边，外压边的上端面上还附着有用于密封穿刺腔的顶部的易撕膜，穿刺腔有两个并分别用于输液和配药，穿刺腔、内塞、阻隔筒和外压边一一对应布设。
进一步地，作为上述技术方案的进一步改进：
进一步地，阻隔筒的底部的待穿刺部位的厚度范围为0.30-0.50mm。
进一步地，外压边的上端面向上凸设有焊接凸起，易撕膜的下端面凹设有用于与焊接凸起焊接连接的焊接凹槽。
进一步地，易撕膜的边缘设有向下弯折形成的易撕边。
进一步地，净空距离≥4.5mm。
进一步地，内塞的顶部设有向下凹设并居中布设的第一内球面，外压边设有用于通过热压形成并抵紧第一内球面的抵紧凸台。
进一步地，内塞的上端面与第一内球面之间的转角处向上凸设有与抵紧凸台的外环面抵接的第一安装凸起。
进一步地，内塞的底部设有向上凹设并居中布设的第二内球面。
进一步地，阻隔筒的上端面与内塞的下端面抵紧，内塞的下端面与第二内球面之间的转角处向下凸设有与阻隔筒的内壁面抵接的第二安装凸起。
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外盖式覆膜盖。
本发明具有以下有益效果：
本发明的输液容器用无外盖式覆膜盖，首先通过注塑工艺获得具有两个穿刺腔的内盖，然后将配药的内塞和输液的内塞分别塞入两个彼此隔离独立成腔的穿刺腔中，使配药及输液方便、安全，避免药液受到污染，穿刺腔的底部通过阻隔筒密封，阻隔筒在无外盖式覆膜盖内腔中呈下沉式结构设计，避免输液容器内的药液与内塞接触而污染，且通过净空距离使得侧孔穿刺针穿刺阻隔筒的底部的待穿刺部位时侧孔穿刺针的侧孔部位完全脱离内塞，以有效避开侧孔穿刺针穿刺阻隔筒时由小到最大到最小的穿刺切削力，进而杜绝侧孔针穿刺产生的内塞落屑或者最大限度减少内塞产生落屑的几率，外压边和内盖采用注塑工艺一体成型且注塑时内盖轴向延伸形成未弯折的外压边，然后通过热压工艺使外压边朝向内塞方向折弯，且外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，弯折成型的外压边完全贴紧和包覆于内塞表面，最后通过焊接工艺将易撕膜焊接覆盖在外压边的上端面上，以密封穿刺腔的顶部，避免内塞与外界环境接触而污染，本方案通过内盖、外压边和易撕膜相互协同配合，以实现对内塞的固定和密封，且阻隔筒和两个穿刺腔的设置，侧孔穿刺针不易产生穿刺落屑，且配药和输液可分别进行，以杜绝或者最大程度的消除内塞被外界环境污染和药液被污染的几率，同时相对于现有技术，在实现固定密封内塞的基础上，通过外压边和易撕膜共同作用以取代材料要求高、价格较为昂贵的外盖，大大降低输液容器盖的制造成本，且易撕膜相对于外盖打开难度低，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外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外盖式覆膜盖的剖面示意图。
图例说明：
1、内盖；11、穿刺腔；12、阻隔筒；13、穿刺部；2、内塞；21、第一内球面；22、第一安装凸起；23、第二内球面；24、第二安装凸起；3、外压边；31、焊接凸起；32、抵紧凸台；4、易撕膜；41、易撕边。
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外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外盖式覆膜盖的剖面示意图。
如图1-图2所示，本实施例的输液容器用无外盖式覆膜盖，包括内盖1，内盖1包括穿刺腔11，穿刺腔11内布设有内塞2，内盖1还包括布设于穿刺腔11的底部的用于密封穿刺腔11的底部的阻隔筒12，阻隔筒12的底部和内塞2的待穿刺部位之间留有用于侧孔穿刺针穿刺阻隔筒12的底部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，穿刺腔11的顶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的外压边3，外压边3的上端面上还附着有用于密封穿刺腔11的顶部的易撕膜4，穿刺腔11有两个并分别用于输液和配药，穿刺腔11、内塞2、阻隔筒12和外压边3一一对应布设。具体地，本发明的输液容器用无外盖式覆膜盖，首先通过注塑工艺获得具有两个穿刺腔11的内盖1，然后将配药的内塞2和输液的内塞2分别塞入两个彼此隔离独立成腔穿刺腔11中，使配药及输液方便、安全，避免药液受到污染，穿刺腔11的底部通过阻隔筒12密封，阻隔筒12在无外盖式覆膜盖内腔中呈下沉式结构设计，避免输液容器内的药液与内塞2接触而污染，且通过净空距离使得侧孔穿刺针穿刺阻隔筒12的底部的待穿刺部位时侧孔穿刺针的侧孔部位完全脱离内塞2，以有效避开侧孔穿刺针穿刺阻隔筒12时由小到最大到最小的穿刺切削力，进而杜绝侧孔针穿刺产生的内塞2落屑或者最大限度减少内塞2产生落屑的几率，外压边3和内盖2采用注塑工艺一体成型且注塑时内盖1轴向延伸形成未弯折的外压边3，然后通过热压工艺使外压边3朝向内塞2方向折弯，且外压边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，弯折成型的外压边3完全贴紧和包覆于内塞2表面，最后通过焊接工艺将易撕膜4焊接覆盖在外压边3的上端面上，以密封穿刺腔11的顶部，避免内塞2与外界环境接触而污染，本方案通过内盖1、外压边3和易撕膜4相互协同配合，以实现对内塞2的固定和密封，且阻隔筒12和两个穿刺腔11的设置，侧孔穿刺针不易产生穿刺落屑，且配药和输液可分别进行，以杜 绝或者最大程度的消除内塞2被外界环境污染和药液被污染的几率，同时相对于现有技术，在实现固定密封内塞2的基础上，通过外压边3和易撕膜4共同作用以取代材料要求高、价格较为昂贵的外盖，大大降低输液容器盖的制造成本，且易撕膜4相对于外盖打开难度低，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采用具有一定弹性的硅胶制成。应当理解的是，净空距离，可有效确保内塞2不过于压实，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，充分发挥内塞2本身的弹性作用，最大限度减少穿刺针产生切削阻力，从而杜绝或最大限度减少侧孔穿刺针穿刺产生的内塞2落屑产生的几率。净空距离，也可对穿刺时如果内塞2产生的落屑起到隔离的作用，并被阻隔在阻隔筒12与内塞2之间，从而杜绝或最大限度减少内塞2落屑进入药液中的几率。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。
本实施例中，阻隔筒12的底部的待穿刺部位的厚度范围为0.30-0.50mm。具体地，当阻隔筒12的底部的待穿刺部位的厚度处于0.30-0.50mm之间时，阻隔筒12的底部的待穿刺部位强度适当，穿刺难度低，且穿刺针穿刺时不易破裂而使内塞2落屑落入药液中；当阻隔筒12的底部的待穿刺部位的厚度小于0.30mm时，注塑过程中易被烧穿，阻隔筒12的底部的待穿刺部位强度过低，穿刺针穿刺时易破裂而导致内塞2落屑落入药液中；当阻隔筒12的底部的待穿刺部位的厚度大于0.5mm时，阻隔筒12的底部的待穿刺部位过高，穿刺针穿刺难度大。优选地，阻隔筒12的底部的待穿刺部位的厚度范围为0.39-0.45mm。
如图2所示，本实施例中，外压边3的上端面向上凸设有焊接凸起31，易撕膜4的下端面凹设有用于与焊接凸起31焊接连接的焊接凹槽。具体地，通过焊接凹槽和焊接凸起31以将易撕膜4可靠焊接于外压边3的上端面上。
如图2所示，本实施例中，易撕膜4的边缘设有向下弯折形成的易撕边41。具体地，通过易撕边41便于医护人员撕开易撕膜4，进而露出内塞2。可选地，易撕边41上布设有用于增加摩擦力的防滑纹，防滑纹为凹凸状结构。
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的顶部设有向下凹设并居中布设的第一内球面21，外压边3设有用于通过热压形成并用于抵紧第一内球面21的抵紧凸台32。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，再通过抵紧凸台32抵紧第一内球面21，实现对内塞2的稳定固定。应当理解的是，抵紧凸台32通过热压形成，因此，热压过程中抵紧凸台32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的上端面与第一内球面21之间的转角处向上凸设有与抵紧凸台32的外环面抵接的第一安装凸起22。具体地，通过第一安装凸起22抵接抵接凸台 的外环面，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的稳定固定。
如图2所示，本实施例中，内塞2的底部向上凹设有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，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。
如图2所示，本实施例中，阻隔筒12的上端面与内塞2的下端面抵紧，内塞2的下端面与第二内球面23之间的转角处向下凸设有与阻隔筒12的内壁面抵接的第二安装凸起24。具体地，通过阻隔筒12的内壁面与第二安装凸起24抵接，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。
如图2所示，本实施例中，外压边3和内盖1之间凹设有用于便于外压边3热压时定长度和弯折成型的折弯凹角。具体地，折弯凹角的设置，外压边3热压时易于弯折，以保证外压边3弯折成型后上端面的水平，进而提高焊接覆盖阻隔膜后的密封性，且弯折长度易取决于折弯凹角的位置，使得外压边3各个尺寸相对固定，便于注塑成型。应当理解的是，折弯凹角部分基体厚度薄，经过热压，在折弯凹角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，外压边3和内盖1之间的凹设有折弯凹角的转角处的厚度范围为0.4-0.8mm。具体地，当外压边3和内盖1之间的凹设有折弯凹角的转角处的厚度处于0.4-0.8mm之间时，外压边3易于弯折，且外压边3和内盖1之间的凹设有折弯凹角的转角处的强度有保证；当外压边3和内盖1之间的凹设有折弯凹角的转角处的厚度小于0.4mm时，外压边3和内盖1之间的凹设有折弯凹角的转角处强度无法保证，容易热压时或者使用过程中断裂；当外压边3和内盖1之间的凹设有折弯凹角的转角处的厚度大于0.8mm时，外压边3不易弯折。
如图2所示，本实施例中，外压边3的自由端的远离内塞2的一侧设置为倒角。具体地，通过倒角减少外压边3的自由端的远离内塞2的一侧的用材，便于外压边3通过热压向下弯折成型。
本实施例中，外压边3的厚度范围为1.0-2.0mm。具体地，当外压边3的厚度处于1.0-2.0mm之间时，外压边3的强度适当，热压时容易弯折成型；当外压边3的厚度小于1.0mm时，外压边3的强度无法保证，可能在热压弯折过程中断裂，弯折难度大；当外压边3的厚度大于2.0mm时，外压边3弯折时的内应力过大，易在折弯处断裂，弯折难度大。
本实施例中，外压边3围合形成用于与穿刺针匹配的穿刺孔，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。
本实施例的输液容器，包括上述的输液容器用无外盖式覆膜盖。具体地，通过采用上述的输液容器用无外盖式覆膜盖，以降低输液容器的制造成本，同时避免内塞2和药液受到污染，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. 一种输液容器用无外盖式覆膜盖，包括内盖(1)，内盖(1)包括穿刺腔(11)，穿刺腔(11)内布设有内塞(2)，其特征在于，内盖(1)还包括布设于穿刺腔(11)的底部的用于密封穿刺腔(11)的底部的阻隔筒(12)，阻隔筒(12)的底部和内塞(2)的待穿刺部位之间留有用于侧孔穿刺针穿刺阻隔筒(12)的底部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，穿刺腔(11)的顶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)的外压边(3)，外压边(3)的上端面上还附着有用于密封穿刺腔(11)的顶部的易撕膜(4)，穿刺腔(11)有两个并分别用于输液和配药，穿刺腔(11)、内塞(2)、阻隔筒(12)和外压边(3)一一对应布设。
  2. 根据权利要求1所述的输液容器用无外盖式覆膜盖，其特征在于，阻隔筒(12)的底部的待穿刺部位的厚度范围为0.30-0.50mm。
  3. 根据权利要求1所述的输液容器用无外盖式覆膜盖，其特征在于，外压边(3)的上端面向上凸设有焊接凸起(31)，易撕膜(4)的下端面凹设有用于与焊接凸起(31)焊接连接的焊接凹槽。
  4. 根据权利要求1所述的输液容器用无外盖式覆膜盖，其特征在于，易撕膜(4)的边缘设有向下弯折形成的易撕边(41)。
  5. 根据权利要求1所述的输液容器用无外盖式覆膜盖，其特征在于，净空距离≥4.5mm。
  6. 根据权利要求1所述的输液容器用无外盖式覆膜盖，其特征在于，内塞(2)的顶部设有向下凹设并居中布设的第一内球面(21)，外压边(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(32)。
  7. 根据权利要求6所述的输液容器用无外盖式覆膜盖，其特征在于，内塞(2)的上端面与第一内球面(21)之间的转角处向上凸设有与抵紧凸台的外环面抵接的第一安装凸起(22)。
  8. 根据权利要求1所述的输液容器用无外盖式覆膜盖，其特征在于，内塞(2)的底部设有向上凹设并居中布设的第二内球面(23)。
  9. 根据权利要求8所述的输液容器用无外盖式覆膜盖，其特征在于，阻隔筒(12)的上端面与内塞(2)的下端面抵紧，内塞(2)的下端面与第二内球面(23)之间的转角处向下凸设有与阻隔筒(12)的内壁面抵接的第二安装凸起(24)。
  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外盖式覆膜盖。
PCT/CN2022/127541 2022-07-29 2022-10-26 输液容器用无外盖式覆膜盖及输液容器 Ceased WO2024021332A1 (zh)

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CN115177525A (zh) * 2022-07-29 2022-10-14 湖南千山制药机械股份有限公司 输液容器用无外盖式覆膜盖及输液容器
CN115778813A (zh) * 2022-11-16 2023-03-14 湖南千山制药机械股份有限公司 闭孔整体式外覆膜接头及输液袋
CN115887218A (zh) * 2022-11-16 2023-04-04 湖南千山制药机械股份有限公司 热压闭孔式易撕膜接头及输液袋
CN116022454A (zh) * 2023-01-05 2023-04-28 湖南千山制药机械股份有限公司 组装外覆膜内一体式西林瓶盖及西林瓶

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