WO2015007243A1 - Disposable multi-needle injection needle and pre-fillable syringe having same - Google Patents

Disposable multi-needle injection needle and pre-fillable syringe having same Download PDF

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Publication number
WO2015007243A1
WO2015007243A1 PCT/CN2014/082577 CN2014082577W WO2015007243A1 WO 2015007243 A1 WO2015007243 A1 WO 2015007243A1 CN 2014082577 W CN2014082577 W CN 2014082577W WO 2015007243 A1 WO2015007243 A1 WO 2015007243A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
tube
injection
disposable multi
needle tube
Prior art date
Application number
PCT/CN2014/082577
Other languages
French (fr)
Chinese (zh)
Inventor
岳瑞峰
王燕
Original Assignee
清华大学
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 清华大学 filed Critical 清华大学
Publication of WO2015007243A1 publication Critical patent/WO2015007243A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
    • A61M5/3298—Needles arranged in parallel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/288—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened by piercing without internal pressure increase

Definitions

  • the present invention relates to the field of medical device technology, and in particular to a disposable injection needle and a prefilled syringe including the same. Background technique
  • the injection pen is provided at one end of the insulin injection pen, and the cylindrical barrel of the disposable needle is placed on the interface of the injection reservoir during use, while the needle in the column is pierced through the top of the injection reservoir.
  • the elastic layer is used to extract the liquid medicine.
  • the needle holder of the existing array needle and even the needle holder of the needle holder are connected to the reservoir, and the liquid medicine is directly contacted during use, so it is necessary to ensure a reliable seal between them to prevent leakage, and the sealing material
  • the preparation materials for the needle holder and the needle holder must use special medical materials suitable for transporting the liquid medicine. Therefore, the selection of the above materials, the needle structure and the sealing assembly process have very strict requirements, and the structure and process are complicated, resulting in manufacturing. Higher cost and lower yield.
  • the disposable injection needles on the existing insulin injection pens must be used in conjunction with the insulin injection pens, which are stored separately in the same time and temporarily assembled together during use.
  • the entire injection device is bulky and heavy, and is only suitable for injecting insulin. Summary of the invention
  • the present invention aims to solve at least one of the technical problems existing in the prior art.
  • one object of the present invention is The invention provides a disposable multi-needle injection needle, which solves the problem that the injection of the existing insulin pen with a disposable injection needle is too concentrated under the skin, resulting in slow absorption and easy induration at the injection site.
  • the problem of easy liquid leakage, long injection time and inconvenient use solves the problems of the existing structure and manufacturing process of the array needle, and the high cost and low yield.
  • Another object of the present invention is to provide a prefilled syringe comprising the injection needle.
  • a disposable multi-needle injection needle comprising: a needle hub, the needle hub comprising a cylindrical barrel and a top cover, the upper end and the lower end of the cylindrical barrel being open, the top cover
  • the top cover is provided with a through hole;
  • the top cover is provided with a through hole;
  • the positioning structure the positioning structure is disposed on the top cover;
  • the needle tube fixing member the needle tube fixing member is positioned by the positioning structure a plurality of needle tubes, the needle tube passing through the needle tube fixing member and fixed to the needle tube fixing member, the lower end of the needle tube extending into the cylindrical barrel through the through hole for breaking into the injection liquid reservoir Taking the liquid, the upper end of the needle tube extends upward for piercing the skin and is injected, and the plurality of needle tubes are spaced apart from each other, and the upper end and the lower end of the needle tube have a needle tip.
  • the needle cannula holder includes a substrate portion that is positioned in the positioning structure, wherein a plurality of the needle tubes pass through the substrate portion and are fixed to the substrate portion.
  • the substrate portion is formed as a flat plate or a curved panel.
  • the needle tube fixture further includes: a filling portion, the filling portion is connected to the substrate portion, the filling portion is located in or through the through hole, and the needle tube is worn The substrate portion and the filling portion are fixed to the substrate portion and the filling portion.
  • the substrate portion and the filling portion are integrally formed of a polymer.
  • the substrate portion and the filling portion are integrally molded with a resin.
  • the positioning structure comprises: a positioning clip wall, the positioning clip wall is disposed on an upper surface of the top cover, and the needle tube fixing member is installed in the positioning clip wall.
  • the positioning clip walls are annular clip walls or a plurality of sub-clamping wall portions spaced apart from each other along the circumferential direction of the cylindrical barrel.
  • the positioning clip wall is provided with a protrusion for clamping the substrate portion.
  • the top of the needle cannula protrudes from the positioning clip wall and extends toward the top of the positioning clip wall.
  • the positioning structure further includes a protrusion extending downward from a lower surface of the top cover, the through hole penetrating the protrusion, wherein a lower end of the needle passes through the protrusion The starting portion projects into the cylindrical barrel.
  • the cross section of the through hole gradually increases in a direction from top to bottom or from bottom to top, and the needle tube fixing member is formed by a structural adhesive filled in the through hole to fix the needle tube.
  • the needle is extended from the upper surface of the positioning wall to 0. 2mm-4mm, the needle
  • the length of the tube extending into the cylindrical barrel is 0. 5mm-15mm, and the outer diameter of the needle tube is 60um_450um, and the inner diameter is 30um - 250um.
  • the outer surface of the cylindrical barrel is provided with a non-slip groove or a non-slip groove.
  • the plurality of through holes are plural, and the plurality of the needle tubes respectively pass through the through holes in a one-to-one correspondence.
  • the normal direction of the liquid outlet of the tip of at least two of the needle tubes is different.
  • At least two of the needle tubes extend beyond the positioning structure for piercing the skin and the length of the injected portion is unequal.
  • the shape and/or level of the needle tips of the upper ends of at least two of the needle tubes are not equal.
  • the disposable multi-needle injection needle further includes a needle protection sleeve and a needle holder, and the needle protection sleeve is disposed on an outer surface of the positioning structure on the top cover for protecting the needle tube.
  • the needle guard sleeve is sleeved outside the needle seat and the needle guard, and the lower end of the needle guard is open and closed by a layer of sealing material.
  • a prefilled syringe comprising: a disposable multi-needle injection needle according to an embodiment of the first aspect of the present invention; an injection reservoir, the injection reservoir and an inner wall of the cylindrical barrel
  • the injection reservoir includes a barrel, an elastomer layer, and a piston, the barrel having an opening at the top and the bottom thereof and a volumetric scale on the barrel, the elastomer layer being fixed on the top of the barrel An opening for sealing the top of the cylinder, the piston being disposed at the bottom of the cylinder.
  • the lower end of the barrel is integrally connected with a bent section, and the free end of the bent section is screwed or snapped with the outer wall of the cylindrical barrel.
  • a disposable multi-needle injection needle wherein a plurality of needle tubes are directly passed through a through hole in the needle cover top cover and are fixedly disposed on the top cover of the needle holder by the needle tube fixing member
  • needle tips at both ends of the needle tube which are used for liquid extraction and injection respectively, so that a certain dose of insulin can be injected into the skin at the same time, the penetration force is small, the injection time is short, and the absorption of insulin is facilitated, and the liquid is not leaked, which is effective. Avoid inferior fat hyperplasia at the injection site and produce induration.
  • this disposable multi-needle injection needle does not need to be sealed between the needle holder and the needle holder and the drug reservoir because only the needle tube contacts the liquid medicine.
  • the structure and manufacturing process become simpler, the yield rate is greatly improved, the cost is low, and the risk that the needle cannot be used due to clogging of the single liquid take-up needle during the threading process is reduced, and the reliability of the injection is improved;
  • the insertion or removal operation is suitable for a stable and reliable connection with the reservoir interface produced by all pharmaceutical companies. Therefore applicability, ease of use.
  • the needle tube protrudes from the positioning structure for piercing the skin and the length of the injected portion is short, conventional injection techniques such as pinching and needle tilting can be omitted, and the effective injection in the arm, thigh, abdomen, etc. can be conveniently performed. Inject the site without worrying about intramuscular injection.
  • Prefilled syringe combines a disposable multi-needle injection needle with an injection reservoir Together, it is more convenient and quick to use, the device is small and light, and is not limited to insulin injection. It can also be applied to other drug injections, and the application prospect is more extensive.
  • FIG. 1 is a cross-sectional view of a disposable multi-needle injection needle according to a first embodiment of the present invention
  • FIG. 2 is a cross-sectional view of a disposable multi-needle injection needle according to a second embodiment of the present invention, wherein the positioning wall and the figure are
  • Figure 3 is a cross-sectional view of a disposable multi-needle injection needle according to a third embodiment of the present invention, wherein the needle holder is different from Figure 1;
  • Figure 4 is a cross-sectional view of a disposable multi-needle injection needle according to a fourth embodiment of the present invention, showing another needle holder;
  • Figure 5 is a cross-sectional view of a disposable multi-needle injection needle according to a fifth embodiment of the present invention.
  • Figure 6 is a cross-sectional view of a disposable multi-needle injection needle according to a sixth embodiment of the present invention, showing another needle holder;
  • Figure 7 is a cross-sectional view of a disposable multi-needle injection needle according to a seventh embodiment of the present invention, showing a further needle holder;
  • Figure 8 is a perspective view showing the structure of a disposable multi-needle injection needle according to an eighth embodiment of the present invention.
  • FIG. 9 is a schematic perspective structural view of a disposable multi-needle injection needle according to Embodiment 9 of the present invention.
  • Figure 10 is a cross-sectional view showing the structure of a prefilled syringe according to an embodiment of the present invention.
  • connection should be understood broadly, and may be either fixed or detachable, unless explicitly stated or defined otherwise.
  • Connected, or connected integrally can be mechanical or electrical; can be directly connected, or indirectly connected through an intermediate medium, can be the internal communication of the two components.
  • the specific meaning of the above terms in the present invention can be understood in the specific case for those skilled in the art.
  • a disposable multi-needle injection needle according to an embodiment of the first aspect of the present invention will now be described with reference to Figs.
  • a disposable multi-needle injection needle according to an embodiment of the present invention includes: a needle hub 1, a positioning structure, a needle tube fixing member 9, and a plurality of needle tubes 2, as shown in Fig.
  • the needle holder 1 is formed as a hollow cylindrical barrel 5
  • the lower end of the needle hub 1 is open and the top end has a top cover 3, and the top cover 3 has a through hole 4,
  • the positioning structure is disposed on the top cover 3,
  • the needle tube fixing member 9 is positioned by the positioning structure, and the needle tube 2 passes through the needle tube fixing member 9 and
  • the needle tube 2 is fixed on the needle tube fixing member 9, and the lower end of the needle tube 2 is inserted into the cylindrical barrel 5 through the through hole 4 for taking in the injection liquid to take the liquid.
  • the upper end of the needle tube 2 is extended upward for the skin to be injected and injected, and the plurality of needle tubes are inserted. 2 is spaced apart from each other.
  • the number of the needle tubes 2 in the embodiment is not limited to three, and may be two, four or more.
  • the distribution of the needle tubes 2 is not limited to the array arrangement, as long as they are discretely arranged.
  • the needle tube fixing member 9 can be used.
  • the plurality of needle tubes 2 are arranged in a one-dimensional array, and in another alternative example, the plurality of needle tubes 2 are arranged in a planar two-dimensional array.
  • each needle tube has a needle tip, and the needle tip structure at both ends may be different.
  • the needle tip located above the top cover 3 is used for breaking into the skin and the injection, and the needle tip placed in the column barrel 5 is used for breaking into the injection liquid storage so as to be Extract the liquid.
  • the needle tube fixing member 9 is stably disposed on the top cover 3 of the needle holder 1 by a positioning structure, thereby forming An array of multi-needle injection needles through which a dose of insulin can be dispensed into the skin simultaneously.
  • the small insertion force and short injection time are beneficial to the rapid absorption of insulin and are not easy to leak. It avoids the phenomenon that the injection of insulin in a single needle tube is too long at the injection site to cause subcutaneous fat hyperplasia and induration. When injected, it can be injected vertically. Easy to use.
  • the needle holder 9 includes: a substrate portion 7 positioned in the positioning structure, wherein the plurality of needle tubes 2 pass through the substrate portion 7 and are fixed to the substrate portion 7, as shown in FIG.
  • the substrate portion 7 is formed as a flat plate or a curved panel.
  • the needle tube fixing member 9 further includes: a filling portion 10 connected to the lower end of the substrate portion 7, and the filling portion 10 is located in or through the through hole 4, and the needle tube 2 passes through The substrate portion 7 and the filling portion 10 are fixed to the substrate portion 7 and the filling portion 10. As shown in Fig.
  • the needle tube fixing member 9 is a convex structure including an integrated substrate portion 7 and a filling portion 10, the substrate portion 7 is located above the top cover 3, and the filling portion 10 passes through the through hole 4, since the needle tube is usually
  • the portion which is very thin and located in the cylindrical barrel is long, and the length of contact between the needle tube 2 and the needle tube fixing member 9 can be increased by the filling portion 10, and the length of the needle tube 2 exposed in the cylindrical barrel 5 can be effectively reduced, thereby making the needle tube 2 It is relatively stable and the mechanical strength is further improved to facilitate the infusion into the injection reservoir.
  • the length of the filling portion 10 should not affect the withdrawal of the needle tube 2.
  • the substrate portion 7 and the filling portion 10 are integrally molded with a polymer.
  • the substrate portion 7 and the filling portion 10 are integrally molded with a resin, and the substrate portion 7 and the filling portion 10 can be integrally molded by using an epoxy resin, and at the same time, the plurality of needle tubes 2 can be firmly fixed therein in accordance with a set distribution.
  • the positioning structure includes a positioning clip wall 6, and a positioning clip wall 6 is provided on the upper surface of the top cover 3.
  • the inner surface of the positioning wall 6 has a recess 62 in which the edge of the base portion 7 is accommodated.
  • the positioning clip wall 6 is provided with a card protrusion 61 for fastening the substrate portion 7.
  • the card protrusion 61 can define the groove 62 between the top cover 3 for the card.
  • the substrate portion 7 is fixed.
  • the needle tube fixing member can be directly inserted into the positioning clip wall 6 to be fixed by the card protrusion 61 and the groove 62, and the processes such as bonding and curing are not required, so that the assembly process becomes very simple, the yield can be greatly improved, and the cost can be reduced. .
  • a plurality of needle tubes 2 are arranged in a row, and the needle tube fixing member 9 is inverted L-shaped, and the needle tube fixing member 9 can be firmly fixed even if a part of the positioning clip wall 6 is not provided with the recess 62 and the tab protrusion 61.
  • structural adhesives can be used to further increase the fixing strength.
  • the needle tube fixing member 9 in this embodiment may have other deformations, and the substrate portion 7 may be made of a polymer such as a plastic plate and a structural adhesive, and the plastic plate is connected to the needle tube 2. The portion is filled with a structural adhesive, and the material of the filling portion 10 of the needle holder 9 is a structural adhesive.
  • the needle tube 2 of the present invention can be selected from medical metal needle tubes such as stainless steel, and the structural adhesive can be selected from epoxy resin or structural adhesives of other material types, and the epoxy resin structure adhesive can be combined with metal needle tubes 2, The materials form a strong bond.
  • the needle holder 1 can be made of plastic such as polypropylene, polyethylene or polyvinyl chloride.
  • the positioning clip wall 6 can be integrally formed with the needle holder 1 by injection molding.
  • the positioning wall 6 can also be integrally formed with the needle holder 9 in which a positioning groove (not shown) is provided on the top cover 3 of the needle holder 1 and then fixed in the positioning groove. As shown in FIGS.
  • the positioning wall 6 on the top cover 3 can take a variety of shapes, for example, the projection of the positioning wall 6 on the top cover 3 is formed into a circular shape, an elliptical shape, or a polygonal shape.
  • the positioning clip wall 6 is formed both as an annular clamping wall, while in another alternative example, the positioning clip wall 6 is formed as a plurality of sub-clips spaced apart from one another in the circumferential direction of the cylindrical barrel 1. Wall (not shown).
  • the cylindrical barrel 5 can generally adopt a circular shape similar to a conventional commercially available injection pen needle, but may be other shapes such as a polygonal shape as long as it can be firmly fitted over the interface of the injection liquid reservoir 14.
  • the top cover 3 has a plurality of through holes 4 spaced apart from each other, wherein the plurality of needle tubes 2 are fixed in one-to-one correspondence through the through holes 4, respectively.
  • an array of three through holes 4 is arranged on the top cover 3 of the needle holder 1, and three stainless steel needle tubes 2 each having a needle tip at both ends are directly fixed to the through hole 4 by using an epoxy resin adhesive.
  • the substrate portion 7 and the filling portion 10 of the needle tube fixing member 9 are epoxy resin structural adhesives, and the top portion of the substrate portion 7 may be protruded from the positioning wall 6 and covered in the assembly. The top of the clamping wall 6 is positioned.
  • the needle fixing member 9 in the embodiment is formed by filling the structural adhesive in the three through holes 4 and the needle cover 3, the needle fixing member 9 and the through hole 4 can be formed.
  • the inner wall and the positioning wall 6 are well bonded, so that it is not necessary to provide the tab 61 and the recess 62 on the positioning wall 6.
  • the needle holder top cover 3 extends downwardly from the convex portion 31, and the substrate of the needle tube fixing member 9 on the needle holder top cover 3
  • the portion 7 is integrally formed with the filling portion 10 located in the through hole 4 and the boss portion 31.
  • the through hole 4 in the needle cover 3 may be a tapered hole, that is, the cross section of the through hole 4 is from the upper end (for example, the upper end in FIG. 7) to the lower end (for example, in FIG. 7). The lower end) is gradually increased.
  • the through hole 4 may also be a straight hole, that is, the cross section of the through hole 4 is constant from the upper end to the lower end.
  • the epoxy tube structural adhesive may be used to fix the needle tube 2 from the upper surface of the needle seat top cover 3, or the epoxy resin structure adhesive may be used to fix the needle tube 2 from the lower surface of the needle tube top cover 3, and the epoxy resin structure is adhesive.
  • the needle tube fixing member 9 is formed, and the boss portion 31 also serves to define the needle tube fixing member 9.
  • the needle tube 2 may be disposed to protrude from the needle tip of the positioning wall 6 of the top cover 3.
  • the normal direction of the liquid port can be different.
  • the shape and/or the level of the tips of the upper ends of at least two of the needle tubes 2 are not equal, for example, the length of the portion of the needle tube 2 extending out of the positioning clip wall 6 for piercing the skin and being injected may be unequal.
  • the shape and size of the needle tip at both ends of the needle tube 2 can also be different, but it must be structurally strong, easy to wear, and difficult to block the pipe.
  • the needle tube array may be a one-dimensional array arranged in a row or a planar two-dimensional array.
  • an anti-slip pattern may be provided on the outer surface of the cylindrical barrel 5, and an anti-slip pattern may be provided even on the outer surface of the needle tube protective cover 11. Therefore, it can be directly inserted or pulled out during use, and has strong applicability and convenient use.
  • a projection may also be provided on the inner wall of the hub protector 12 to make it easier to remove the hub 1.
  • the needle tube used is very thin and the length of the needle tube for injecting the injection is very short, it is possible to use a vertical injection in an effective injection site such as an arm, a thigh or an abdomen without taking into consideration an injection method such as kneading, and the injection needle 2 can be completely subcutaneously injected into the skin. It is very convenient to use, and it is easy to implement the injection of the rotating part without the risk of intramuscular injection. It can easily achieve slight pain or even no painful injection, thereby obviously improving the patient's compliance and treatment effect.
  • the needle tube 2 can be made of various medical metal materials such as stainless steel, and the needle holder 1 can be made of plastic such as polypropylene or polyethylene.
  • the above-mentioned injection needle can be used in combination with an existing insulin pen, and can also be used in combination with an existing or future syringe or injection reservoir of other drugs, and a plurality of syringes in the column of the present invention.
  • the plurality of liquid intake ports can be used in combination with injection solutions of different drugs.
  • the disposable multi-needle injection needle can also include a needle guard 12 and a needle guard 11.
  • the positioning structure on the top cover 3 of the needle holder 1 is provided with a needle protection sleeve 11, and the needle holder 1 and the needle protection sleeve 11 are provided with a needle holder 12, and the lower end of the needle holder 12 is opened and the sealing material layer 13 is provided. Closed.
  • the sealing material may be made of medical materials such as sealed dialysis paper.
  • the needle protection sleeve 11 and the needle holder 12 can be prepared by using various materials such as polypropylene, polyvinyl chloride, etc.
  • the needle protection sleeve 11 can prevent the needle from being bent and damaged during storage and transportation, and the needle holder can be protected by setting the needle holder.
  • the sleeve 12 and the sealing material layer 13 ensure that the needle tube is kept in a clean and sterile environment for a period of use after the needle is sterilized by epoxy oxime or the like.
  • a disposable multi-needle injection needle in accordance with various embodiments of the present invention is described below with reference to Figures 1-9.
  • the injection needle includes a needle holder 1, three needle tubes 2, a needle tube fixing member 9, a positioning wall 6, a needle tube protective sleeve 11, a needle holder 12 and a sealing material layer 13.
  • the needle holder 1 is a cylindrical barrel 5 having an opening at one end and a top cover 3 at the other end, and a through hole 4 is formed in the top cover 3 of the needle holder 1.
  • the needle tube 2 passes through the through hole 4 of the top cover 3 of the needle holder 1 and is fixedly disposed on the top cover 3 of the needle holder 1 by the needle tube fixing member 9.
  • the needle tube 2 has a needle tip at both ends, and the needle tip structure at both ends can be Differently, the needle tip located above the top cover 3 is used for breaking into the skin and the injection, and the needle tip placed in the cylindrical barrel 5 is used for breaking into the injection liquid reservoir for extracting the medical liquid.
  • the needle tube fixing member 9 is a convex structure including an integrated substrate portion 7 and a filling portion 10, the substrate portion 7 is located above the top cover 3, and the filling portion 10 passes through the through hole 4, since the needle tube is usually very thin and is located in the column tube
  • the inner portion is longer, and the length of contact between the needle tube 2 and the needle tube fixing member 9 can be increased by the filling portion 10, and the length of the needle tube 2 exposed in the cylindrical barrel 5 can be effectively reduced, thereby making the needle tube 2 relatively stable and further mechanically strong. Increased to facilitate injection into the injection reservoir
  • the liquid is taken, of course, the length of the filling portion 10 should not affect the liquid taking of the needle tube 2; the substrate portion 7 and the filling portion 10 are integrally manufactured using a polymer material or a structural adhesive.
  • a positioning clip wall 6 is disposed above the top cover 3 for defining a radial position of the base portion 7 of the needle holder 9 , and an inner wall of the positioning wall 6 has a projection 61 and a recess 62 for engaging the substrate portion 7 in the recess 62
  • the needle tube fixing member 9 can be made more stable.
  • the substrate portion 7 of the needle tube fixing member 9 can be bonded to the top cover 3 of the needle holder 1 by using a structural adhesive.
  • a needle protection sleeve 11 is sleeved on the outer wall of the positioning wall 6
  • a needle protection sleeve 12 is sleeved on the outside of the needle protection sleeve 11 and the needle holder 1
  • a sealing material layer 13 is disposed at the opening of the lower portion of the needle holder 12
  • the sealing material can be selected from medical materials such as sealed dialysis paper.
  • the number of the needle tubes 2 in the present embodiment is not limited to three, and may be two, four or more.
  • the distribution of the needle tubes 2 is not limited to the array arrangement, as long as it can be dispersedly disposed on the needle tube fixing member 9, can.
  • the needle tube 2 is dispersedly disposed on the needle tube fixing member 9 made of epoxy resin, and then the needle tube fixing member 9 is directly inserted into the positioning clip wall 6, through the card protrusion 61 and the groove
  • the structure of the 62 can be stably disposed on the top cover 3 of the needle holder 1, thereby forming an array type multi-needle tube 2 injection needle, which does not require bonding, curing, etc., so that the assembly process becomes very simple, and the yield can be significantly improved. Significantly reduce costs.
  • a certain dose of insulin can be injected into the skin at the same time, and the injection time is short, which is beneficial to the rapid absorption of insulin and is not easy to leak, and avoids the excessive accumulation of insulin in a single needle tube at the injection site for a long time to cause subcutaneous fat hyperplasia.
  • induration it can be injected vertically and conveniently used.
  • the needle protection sleeve 11 and the needle seat protection sleeve 12 can be selected from various types.
  • the material is prepared by plastics such as polypropylene and polyvinyl chloride.
  • the needle protection sleeve 11 can prevent the needle from being bent and damaged during the storage and transportation process.
  • the injection needle in this embodiment is substantially the same as that in the first embodiment, except that a plurality of needle tubes are arranged in a row, and the needle tube fixing member 9 is inverted L-shaped even if a part of the positioning clip wall 6 is formed.
  • the provision of the clip 61 and the recess 62 in the middle can also securely fix the needle holder 9 and further increase the fixing strength by using a structural adhesive.
  • Embodiment 3
  • the injection needle in the present embodiment is substantially the same as that in the first embodiment, except that the needle tube fixing member 9 is directly simplified to the substrate portion 7, which is a flat plate, but may be Curved panel.
  • the substrate portion 7, which is a flat plate, but may be Curved panel is a flat plate, but may be Curved panel.
  • the injection needle in this embodiment is substantially the same as that in the first embodiment, except that the needle tube fixing member 9 in this embodiment may have other deformations, and the substrate portion 7 may be made of a polymer.
  • the plastic sheet is made of a structural adhesive, and the material of the filling portion 10 of the needle fixing member 9 is a structural adhesive.
  • the injection needle in this embodiment is substantially the same as that in the first embodiment, except that the number of the through holes 4 in the needle hub top cover 3, the needle tube fixing member 9 and the structure of the positioning clip wall 6 are shown. .
  • an array of three through holes 4 is arranged on the top cover 3 of the needle holder 1, and three stainless steel needle tubes 2 each having a needle tip at both ends are directly fixed by an epoxy resin structural adhesive.
  • the substrate portion 7 and the filling portion 10 of the needle tube fixing member 9 are epoxy resin structural adhesives, and the top portion of the substrate portion 7 protrudes from the positioning wall 6 and is covered by The top of the clamping wall 6 is positioned. Since the needle fixing member 9 in the embodiment is formed by filling the structural adhesive in the three through holes 4 and the needle cover 3, the needle fixing member 9 and the through hole 4 can be formed.
  • the inner wall and the positioning wall 6 are well bonded, so that it is not necessary to provide the tab 61 and the recess 62 on the positioning wall 6.
  • the injection needle in this embodiment is substantially the same as that in the fifth embodiment, except that in order to improve the stability of the needle tube 2 on the needle tube fixing member 9, the lower surface of the needle holder top cover 3 may be provided.
  • the boss portion 31 defining the needle tube fixing member 9 is also provided to extend downward, and the base plate portion 7 of the needle tube fixing member 9 on the needle holder top cover 3 is integrally connected with the filling portion 10 located in the through hole 4 and the boss portion 31.
  • the through hole 4 in the needle cover 3 can be a straight hole or a tapered hole, and the needle tube 2 can be fixed from the upper surface of the needle cover 3 by using an epoxy resin adhesive.
  • the needle tube 2 is fixed from the lower surface of the needle cap 3 by using an epoxy resin structural adhesive.
  • the needle fixing member 9 is formed, and the convex portion 31 is disposed under the top cover 3 of the needle holder 1.
  • the convex portion 31 extends downward from the array area of the tapered through holes 4 on the top cover 3 of the needle holder 1.
  • the through hole 4 in the convex portion 31 is a downward extension of the through hole 4 in the needle cover 3
  • the boss 31 also serves to define the needle holder 9 .
  • the positioning clip wall 6 in this embodiment has a square structure, that is, the projection of the positioning clip wall 6 on the top cover 3 is formed into a square shape.
  • the positioning wall 6 in this embodiment has a cylindrical structure, that is, the projection of the positioning wall 6 on the top cover 3 is formed into a circular shape.
  • a disposable multi-needle injection needle according to an embodiment of the present invention has the following advantages:
  • a plurality of needle tubes are directly passed through the through holes in the top cover of the needle holder and are fixedly disposed on the top cover of the needle holder by the needle tube fixing member, and the needle ends are provided at both ends of the needle tube, respectively It is used for liquid extraction and injection, so that a certain dose of insulin can be injected into the skin at the same time.
  • the injection time is short, which is beneficial to the absorption of insulin and does not leak liquid. It can effectively avoid subcutaneous fat hyperplasia at the injection site and produce induration.
  • the disposable multi-needle injection needle has a simple structure and a simple manufacturing process, and is low in cost, and reduces the risk that the needle cannot be used due to clogging of a single needle tube, thereby improving the reliability of the injection.
  • a prefilled syringe according to an embodiment of the second aspect of the present invention including a disposable multi-needle injection needle according to the above-described first embodiment, and an injectable reservoir 14 will be described with reference to FIG.
  • the injection reservoir 14 cooperates with and is relatively movable with the inner wall of the cylindrical barrel 5.
  • the injection reservoir includes a barrel, an elastomer layer 16 and a piston 17, and the top and bottom of the barrel are provided with openings, the opening of the barrel and the needle tube
  • the elastomer layer 16 is located at the top of the cylinder for sealing the opening of the top of the cylinder.
  • the elastomer layer 16 is easily pierced by the needle tip of the needle tube 2 in the cylindrical barrel 5.
  • the material of the elastomer layer 16 is rubber.
  • the piston 17 is disposed at the bottom of the cylinder, and the space between the piston 17 and the elastomer layer 16 stores the injection liquid 15.
  • the opening at the bottom of the cylinder facilitates pressing the piston 17, and the injection liquid reservoir 14 is connected to the column cylinder 5, specifically
  • the bottom end of the cylinder is also integrally connected with a bent portion 19, and the free end of the bent portion 19 and the outer wall of the cylindrical barrel 5 have corresponding threaded connection portions 18, and the injection liquid reservoir 14 and the cylindrical barrel 5 are connected thereto.
  • Zone 18 is connected.
  • the free end of the bending section 19 and the outer wall of the cylindrical barrel 5 may also be provided with a matching bayonet structure, and the two may also be snap-fitted by the bayonet.
  • the cylinders of the cylindrical barrel and the injection reservoir are each made of a transparent material such as conventional polypropylene, so that the volume of the volume of the injection reservoir can be easily viewed.
  • the injection reservoir 14 can be manually rotated out of the threaded connection area 18 or the fixed bayonet, and then the injectable reservoir 14 and the cylindrical barrel 5 of the disposable multi-needle injection needle can be relatively slid, and the injection liquid is stored at this time.
  • Device The needle is moved toward the disposable multi-needle injection needle, and the needle is pierced through the top elastic layer 16 until it contacts the injection liquid 15, and finally the bottom end of the piston 17 is squeezed through the injection liquid 15 to perform the injection through the needle tube 2.
  • the use is convenient and quick, the device is small and light, and is not limited to insulin injection, and can also be applied to other drug injections, and is widely used.
  • the disposable multi-needle injection needle and the injection reservoir can be assembled into one body, and are simultaneously sterilized and enclosed in the needle holder 12, or the disposable multi-needle injection needle and the injection reservoir can be separately used. Store and assemble into one when using.
  • the various products of the above embodiments can be manufactured by using existing mature processing techniques and prescribed conventional or new medical materials, and the manufacturing process is simple and the cost is low.
  • the above-mentioned disposable multi-needle injection needle and the injection liquid reservoir are combined, which is more convenient and quick to use, the device is small and light, and is not limited to insulin injection, and can also be applied to other drug injections. , the application prospects are more extensive.

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Abstract

Disclosed are a disposable multi-needle injection needle and a pre-fillable syringe having the injection needle. The injection needle comprises a needle seat (1), a locating structure, a needle fixing piece (9) and a plurality of needles (2); the needle seat (1) comprises a columnar cylinder (5) and a top cover (3), the upper and lower ends of the columnar cylinder (5) are open, the top cover (3) is arranged on the upper end of the columnar cylinder (5) and is provided with a through hole (4); the locating structure is arranged on the top cover (3); the needle fixing piece (9) is located via the locating structure; the needles (2) pass through the needle fixing piece (9) and are fixed on the needle fixing piece (9), the lower ends of the needles (2) stretch into the columnar cylinder (5) via the through hole (4) in order to pierce into an injection storage unit for obtaining the injection, the upper ends of the needles (2) extend upwards with the aim of piercing into skin and completing the injection, the plurality of needles (2) are distributed at intervals, and both the upper end and lower end of each needle (2) are provided with a bevel.

Description

一次性多针管注射针头及具有其的预灌装注射器  Disposable multi-needle injection needle and pre-filled syringe with same
技术领域 Technical field
本发明涉及医疗器械技术领域，尤其涉及一种一次性注射针头及包括该注射针头的 预灌装注射器。 背景技术  The present invention relates to the field of medical device technology, and in particular to a disposable injection needle and a prefilled syringe including the same. Background technique
现在胰岛素注射笔的一端都设置有注射液存储器，使用时需将一次性笔用注射针头 的柱状筒套在注射液存储器的接口上， 与此同时柱状筒内的针管会剌穿注射液存储器 顶端的弹性层以便提取药液。 目前的胰岛素注射笔用注射针头上均只有一根针管， 在 注射同一剂量的情况下， 药剂都集中注射在同一个部位， 针管长度越短、 剌入的深度 越浅， 虽然能够减小痛感， 但受表皮对药液吸收速率的限制会造成注射时间明显增加， 由于胰岛素本身是种生长因子， 胰岛素在注射部位的长时间积聚必然会导致该部位皮 下脂肪增生而产生硬结。 今后再在这里注射， 胰岛素的吸收率就会明显下降， 必然影 响药效的发挥导致血糖控制的不稳定。 在实际操作中， 因为注入皮下的药液短时间内 未能完全扩散与吸收， 常会有药液从针眼处滴出， 造成漏液， 这样就无法确保治疗剂 量的准确性。 此外， 由于纤细的针管易于堵塞， 如果采用只有一根针管的针头， 糖尿 病患者在注射胰岛素过程中一旦发生针管堵塞后果将不堪设想。  At present, the injection pen is provided at one end of the insulin injection pen, and the cylindrical barrel of the disposable needle is placed on the interface of the injection reservoir during use, while the needle in the column is pierced through the top of the injection reservoir. The elastic layer is used to extract the liquid medicine. At present, there is only one needle on the injection needle for insulin injection. When the same dose is injected, the medicament is concentrated in the same place. The shorter the length of the needle and the shallower the depth of the incision, although the pain can be reduced, However, the limitation of the absorption rate of the drug solution by the epidermis will result in a significant increase in the injection time. Since insulin itself is a growth factor, the long-term accumulation of insulin at the injection site will inevitably lead to infiltration of subcutaneous fat in the site and cause induration. In the future, if the injection is made here, the absorption rate of insulin will be significantly reduced, which will inevitably affect the instability of blood sugar control. In practice, because the liquid injected into the skin is not completely diffused and absorbed in a short time, the liquid will often drip from the eye of the needle, causing leakage, which will not ensure the accuracy of the therapeutic dose. In addition, since the slender needle is prone to clogging, if a needle with only one needle is used, it is unimaginable for a diabetic patient to have a needle blockage during insulin injection.
由于各个药厂生产的胰岛素注射笔用注射液存储器上的接口纹饰结构的不同，要求 笔用注射针头的柱状筒内必须设有匹配的接口结构才能使用， 其必然形成对注射针头 和注射液存储器市场的垄断， 也给购买与使用带来很大的不便。  Due to the difference in the interface pattern structure on the injection container for insulin injection pens produced by various pharmaceutical companies, it is required that a matching interface structure must be provided in the cylindrical barrel of the pen needle for injection, which inevitably forms a pair of injection needles and injection reservoirs. The monopoly of the market also brings great inconvenience to purchase and use.
现有阵列式注射针头的针管固定件甚至安装针管固定件的针座都与储药池相通， 使用 时将直接接触药液， 所以必须确保它们之间具有可靠的密封以免漏液， 且密封材料与针管 固定件和针座的制备材料均必须采用适于传输药液的特种医用材料， 因此对上述材料的选 择、 针头结构与密封组装工艺都有非常严格的要求， 结构、 工艺复杂， 导致制造成本较高、 成品率较低。  The needle holder of the existing array needle and even the needle holder of the needle holder are connected to the reservoir, and the liquid medicine is directly contacted during use, so it is necessary to ensure a reliable seal between them to prevent leakage, and the sealing material The preparation materials for the needle holder and the needle holder must use special medical materials suitable for transporting the liquid medicine. Therefore, the selection of the above materials, the needle structure and the sealing assembly process have very strict requirements, and the structure and process are complicated, resulting in manufacturing. Higher cost and lower yield.
另外， 现有胰岛素注射笔上的一次性注射针头必须结合胰岛素注射笔配套使用， 平 时分开存放， 使用时再临时组装在一起， 整个注射装置体积与重量较大， 且仅适用于 注射胰岛素。 发明内容  In addition, the disposable injection needles on the existing insulin injection pens must be used in conjunction with the insulin injection pens, which are stored separately in the same time and temporarily assembled together during use. The entire injection device is bulky and heavy, and is only suitable for injecting insulin. Summary of the invention
本发明旨在至少解决现有技术中存在的技术问题之一。为此， 本发明的一个目的在 于提出一种一次性多针管注射针头， 所述注射针头一方面解决了现有的胰岛素笔用一 次性注射针头使用时存在的注射液在皮下过于集中导致吸收缓慢、 易使注射部位皮下 产生硬结、 易漏液、 注射时间长和使用不便的问题， 另一方面同时解决现有的阵列式 注射针头存在的结构与制作工艺复杂以及成本较高、 成品率较低问题。 The present invention aims to solve at least one of the technical problems existing in the prior art. To this end, one object of the present invention is The invention provides a disposable multi-needle injection needle, which solves the problem that the injection of the existing insulin pen with a disposable injection needle is too concentrated under the skin, resulting in slow absorption and easy induration at the injection site. The problem of easy liquid leakage, long injection time and inconvenient use, on the other hand, solves the problems of the existing structure and manufacturing process of the array needle, and the high cost and low yield.
本发明的另一个目的是提供一种包括所述注射针头的预灌装注射器。  Another object of the present invention is to provide a prefilled syringe comprising the injection needle.
根据本发明第一方面实施例的一种一次性多针管注射针头， 包括： 针座， 所述针座包 括柱形筒和顶盖， 所述柱形筒的上端和下端敞开， 所述顶盖设在所述柱形筒的上端， 所述 顶盖上开设有通孔； 定位结构， 所述定位结构设在所述顶盖上； 针管固定件， 所述针管固 定件由所述定位结构定位； 多根针管， 所述针管穿过所述针管固定件且固定在所述针管固 定件上， 所述针管的下端通过所述通孔伸入所述柱形筒内用于剌入注射液存储器取液， 所 述针管的上端向上延伸用于穿剌皮肤并注射， 多根所述针管彼此间隔开分布， 所述针管的 上端和下端均具有针尖。  A disposable multi-needle injection needle according to an embodiment of the first aspect of the present invention, comprising: a needle hub, the needle hub comprising a cylindrical barrel and a top cover, the upper end and the lower end of the cylindrical barrel being open, the top cover The top cover is provided with a through hole; the top cover is provided with a through hole; the positioning structure, the positioning structure is disposed on the top cover; the needle tube fixing member, the needle tube fixing member is positioned by the positioning structure a plurality of needle tubes, the needle tube passing through the needle tube fixing member and fixed to the needle tube fixing member, the lower end of the needle tube extending into the cylindrical barrel through the through hole for breaking into the injection liquid reservoir Taking the liquid, the upper end of the needle tube extends upward for piercing the skin and is injected, and the plurality of needle tubes are spaced apart from each other, and the upper end and the lower end of the needle tube have a needle tip.
在一些实施例中，所述针管固定件包括：基板部，所述基板部定位在所述定位结构中， 其中多根所述针管均穿过所述基板部并固定在所述基板部上。  In some embodiments, the needle cannula holder includes a substrate portion that is positioned in the positioning structure, wherein a plurality of the needle tubes pass through the substrate portion and are fixed to the substrate portion.
可选地， 所述基板部形成为平面板或曲面板。  Optionally, the substrate portion is formed as a flat plate or a curved panel.
在一些实施例中， 所述针管固定件还包括： 填充部分， 所述填充部分与所述基板部相 连， 所述填充部分位于所述通孔内或穿过所述通孔， 所述针管穿过所述基板部与填充部分 并固定在所述基板部与填充部分上。  In some embodiments, the needle tube fixture further includes: a filling portion, the filling portion is connected to the substrate portion, the filling portion is located in or through the through hole, and the needle tube is worn The substrate portion and the filling portion are fixed to the substrate portion and the filling portion.
可选地， 所述基板部和所述填充部分采用聚合物一体成型。  Optionally, the substrate portion and the filling portion are integrally formed of a polymer.
在一些实施例中， 所述基板部和所述填充部分采用树脂一体成型。  In some embodiments, the substrate portion and the filling portion are integrally molded with a resin.
在一些实施例中， 所述定位结构包括： 定位夹壁， 所述定位夹壁设在所述顶盖的上表 面上， 所述针管固定件安装在所述定位夹壁内。  In some embodiments, the positioning structure comprises: a positioning clip wall, the positioning clip wall is disposed on an upper surface of the top cover, and the needle tube fixing member is installed in the positioning clip wall.
可选地， 所述定位夹壁为环形夹壁或为沿所述柱形筒的周向彼此间隔开的多个子夹壁 部。  Optionally, the positioning clip walls are annular clip walls or a plurality of sub-clamping wall portions spaced apart from each other along the circumferential direction of the cylindrical barrel.
可选地， 所述定位夹壁上设有用于卡固所述基板部的卡凸。  Optionally, the positioning clip wall is provided with a protrusion for clamping the substrate portion.
在一些实施例中， 所述针管固定件的顶部凸出所述定位夹壁并向所述定位夹壁的顶部 延伸。  In some embodiments, the top of the needle cannula protrudes from the positioning clip wall and extends toward the top of the positioning clip wall.
在一些实施例中， 所述定位结构还包括从所述顶盖的下表面向下延伸的凸起部， 所述 通孔贯穿所述凸起部， 其中所述针管的下端穿过所述凸起部伸入所述柱形筒内。  In some embodiments, the positioning structure further includes a protrusion extending downward from a lower surface of the top cover, the through hole penetrating the protrusion, wherein a lower end of the needle passes through the protrusion The starting portion projects into the cylindrical barrel.
可选地， 所述通孔的横截面沿从上向下或从下向上的方向逐渐增大， 所述针管固定件 由填充在所述通孔内以固定所述针管的结构胶黏剂形成。  Optionally, the cross section of the through hole gradually increases in a direction from top to bottom or from bottom to top, and the needle tube fixing member is formed by a structural adhesive filled in the through hole to fix the needle tube. .
在一些实施例中， 所述针管伸出所述定位夹壁的上表面的长度为 0. 2mm-4mm， 所述针 管伸入所述柱状筒内的长度为 0. 5mm-15mm， 所述针管的外径为 60um_450um， 内径为 30um - 250um。 2毫米-4毫米的针, The needle is extended from the upper surface of the positioning wall to 0. 2mm-4mm, the needle The length of the tube extending into the cylindrical barrel is 0. 5mm-15mm, and the outer diameter of the needle tube is 60um_450um, and the inner diameter is 30um - 250um.
在一些实施例中， 所述柱形筒的外表面设有防滑槽或防滑纹。  In some embodiments, the outer surface of the cylindrical barrel is provided with a non-slip groove or a non-slip groove.
在一些实施例中， 所述通孔为多个， 多根所述针管分别一一对应地穿过所述通孔。 在一些实施例中， 至少两根所述针管的针尖的出液口的法线方向不同。  In some embodiments, the plurality of through holes are plural, and the plurality of the needle tubes respectively pass through the through holes in a one-to-one correspondence. In some embodiments, the normal direction of the liquid outlet of the tip of at least two of the needle tubes is different.
在一些实施例中， 至少两根所述针管伸出所述定位结构用于穿剌皮肤并注射的部分的 长度不相等。  In some embodiments, at least two of the needle tubes extend beyond the positioning structure for piercing the skin and the length of the injected portion is unequal.
在一些实施例中， 至少两根所述针管的上端的针尖的形状和或水平高度不相等。 在一些实施例中， 所述一次性多针管注射针头还包括针管保护套和针座保护套， 所述 针管保护套设在所述顶盖上的定位结构外表面上用于保护所述针管， 所述针座保护套套在 所述针座和针管保护套外面， 所述针座保护套的下端敞开且由密封材料层封闭。  In some embodiments, the shape and/or level of the needle tips of the upper ends of at least two of the needle tubes are not equal. In some embodiments, the disposable multi-needle injection needle further includes a needle protection sleeve and a needle holder, and the needle protection sleeve is disposed on an outer surface of the positioning structure on the top cover for protecting the needle tube. The needle guard sleeve is sleeved outside the needle seat and the needle guard, and the lower end of the needle guard is open and closed by a layer of sealing material.
根据本发明第二方面实施例的一种预灌装注射器，包括：根据本发明第一方面实施例 的一次性多针管注射针头； 注射液存储器， 所述注射液存储器与所述柱状筒的内壁相配合， 所述注射液存储器包括筒体、 弹性体层和活塞， 所述筒体的顶部和底部均设有开口且筒体 上设置有容量刻度， 所述弹性体层固定在筒体的顶部用于密封筒体顶部的开口， 所述活塞 设置在所述筒体的底部。  A prefilled syringe according to an embodiment of the second aspect of the present invention, comprising: a disposable multi-needle injection needle according to an embodiment of the first aspect of the present invention; an injection reservoir, the injection reservoir and an inner wall of the cylindrical barrel In conjunction, the injection reservoir includes a barrel, an elastomer layer, and a piston, the barrel having an opening at the top and the bottom thereof and a volumetric scale on the barrel, the elastomer layer being fixed on the top of the barrel An opening for sealing the top of the cylinder, the piston being disposed at the bottom of the cylinder.
在一些实施例中， 所述筒体的下端一体连接有弯折段， 所述弯折段的自由端与所述柱 状筒的外壁螺纹连接或者卡接。  In some embodiments, the lower end of the barrel is integrally connected with a bent section, and the free end of the bent section is screwed or snapped with the outer wall of the cylindrical barrel.
本发明的上述技术方案具有如下优点：  The above technical solution of the present invention has the following advantages:
根据本发明实施例的一次性多针管注射针头，使多个针管直接穿过所述针座顶盖上 的通孔并且通过所述针管固定件分散地固定设置在所述针座的顶盖上， 针管的两端均 有针尖， 分别用于取液和注射， 这样可以将一定剂量的胰岛素同时分散地注入皮下， 剌入力小， 注射时间短， 有利于胰岛素的吸收， 不漏液， 能有效避免注射部位皮下脂 肪增生而产生硬结， 同时这种一次性多针管注射针头由于只有针管会接触药液， 所以 针管固定件与针座和储药器之间都无需密封连接， 制备材料的选择面大大拓宽， 结构 与制造工艺变得更加简单， 成品率大幅度提高、 成本低廉， 并且降低了针头因单根取 液针管在穿剌过程堵塞而不能使用的风险， 提高了注射的可靠性； 直接采用***或拔出 的操作方式适于与所有药厂生产的储药器接口实现稳固可靠的连接， 因此适用性强、使用 方便。 由于针管伸出所述定位结构用于穿剌皮肤并注射的部分的长度较短， 可以不必 考虑捏皮、 针管倾斜等常规注射技巧， 能够非常方便地在手臂、 大腿、 腹部等多个有 效注射部位注射而不必担心造成肌肉注射。  A disposable multi-needle injection needle according to an embodiment of the present invention, wherein a plurality of needle tubes are directly passed through a through hole in the needle cover top cover and are fixedly disposed on the top cover of the needle holder by the needle tube fixing member There are needle tips at both ends of the needle tube, which are used for liquid extraction and injection respectively, so that a certain dose of insulin can be injected into the skin at the same time, the penetration force is small, the injection time is short, and the absorption of insulin is facilitated, and the liquid is not leaked, which is effective. Avoid inferior fat hyperplasia at the injection site and produce induration. At the same time, this disposable multi-needle injection needle does not need to be sealed between the needle holder and the needle holder and the drug reservoir because only the needle tube contacts the liquid medicine. Greatly widened, the structure and manufacturing process become simpler, the yield rate is greatly improved, the cost is low, and the risk that the needle cannot be used due to clogging of the single liquid take-up needle during the threading process is reduced, and the reliability of the injection is improved; The insertion or removal operation is suitable for a stable and reliable connection with the reservoir interface produced by all pharmaceutical companies. Therefore applicability, ease of use. Since the needle tube protrudes from the positioning structure for piercing the skin and the length of the injected portion is short, conventional injection techniques such as pinching and needle tilting can be omitted, and the effective injection in the arm, thigh, abdomen, etc. can be conveniently performed. Inject the site without worrying about intramuscular injection.
根据本发明实施例的预灌装注射器将一次性多针管注射针头与注射液存储器组合 在一起， 使用更加方便快捷， 装置小巧轻便， 并且不限于胰岛素注射， 也可以适用于 其他药物注射， 应用前景更为广泛。 Prefilled syringe according to an embodiment of the present invention combines a disposable multi-needle injection needle with an injection reservoir Together, it is more convenient and quick to use, the device is small and light, and is not limited to insulin injection. It can also be applied to other drug injections, and the application prospect is more extensive.
本发明的附加方面和优点将在下面的描述中部分给出，部分将从下面的描述中变得 明显， 或通过本发明的实践了解到。 附图说明  The additional aspects and advantages of the invention will be set forth in part in the description which follows. DRAWINGS
本发明的上述和 /或附加的方面和优点从结合下面附图对实施例的描述中将变得明 显和容易理解， 其中：  The above and/or additional aspects and advantages of the present invention will become apparent and readily understood from
图 1是根据本发明实施例一的一次性多针管注射针头的剖视图；  1 is a cross-sectional view of a disposable multi-needle injection needle according to a first embodiment of the present invention;
图 2是根据本发明实施例二的一次性多针管注射针头的剖视图 其中定位夹壁与图 2 is a cross-sectional view of a disposable multi-needle injection needle according to a second embodiment of the present invention, wherein the positioning wall and the figure are
1不同； 1 different;
图 3是根据本发明实施例三的一次性多针管注射针头的剖视图，其中针管固定件与 图 1不同；  Figure 3 is a cross-sectional view of a disposable multi-needle injection needle according to a third embodiment of the present invention, wherein the needle holder is different from Figure 1;
图 4是根据本发明实施例四的一次性多针管注射针头的剖视图，其中示出了另一种 针管固定件；  Figure 4 is a cross-sectional view of a disposable multi-needle injection needle according to a fourth embodiment of the present invention, showing another needle holder;
图 5是根据本发明实施例五的一次性多针管注射针头的剖视图；  Figure 5 is a cross-sectional view of a disposable multi-needle injection needle according to a fifth embodiment of the present invention;
图 6是根据本发明实施例六的一次性多针管注射针头的剖视图，其中示出了另一种 针管固定件；  Figure 6 is a cross-sectional view of a disposable multi-needle injection needle according to a sixth embodiment of the present invention, showing another needle holder;
图 7是根据本发明实施例七的一次性多针管注射针头的剖视图，其中示出了再一种 针管固定件；  Figure 7 is a cross-sectional view of a disposable multi-needle injection needle according to a seventh embodiment of the present invention, showing a further needle holder;
图 8为根据本发明实施例八的一次性多针管注射针头的立体结构示意图;  Figure 8 is a perspective view showing the structure of a disposable multi-needle injection needle according to an eighth embodiment of the present invention;
图 9为根据本发明实施例九的一次性多针管注射针头的立体结构示意图;  9 is a schematic perspective structural view of a disposable multi-needle injection needle according to Embodiment 9 of the present invention;
图 10为根据本发明实施例的预灌装注射器的结构剖视图 附图标记：  Figure 10 is a cross-sectional view showing the structure of a prefilled syringe according to an embodiment of the present invention.
1： 针座； 2 : 针管； 3 : 顶盖； 31 : 凸起部； 4: 通孔； 5 : 柱状筒； 6 : 定位夹壁; 61： 卡凸； 62 : 凹槽； 7 : 基板部； 9 : 针管固定件； 10 : 填充部分；  1: needle seat; 2: needle tube; 3: top cover; 31: raised portion; 4: through hole; 5: cylindrical tube; 6: positioning wall; 61: card convex; 62: groove; ; 9 : needle tube fixture; 10 : filling portion;
11： 针管保护套； 12 : 针座保护套； 13 : 密封材料层；  11: needle guard; 12: needle guard; 13: sealing material layer;
14： 注射液存储器； 15 : 注射液； 16 : 弹性体层； 17 : 活塞； 18 : 螺纹连接区； 19： 弯折段。 具体实施方式 下面详细描述本发明的实施例， 所述实施例的示例在附图中示出， 其中自始至终相 同或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。 下面通过参考 附图描述的实施例是示例性的， 仅用于解释本发明， 而不能理解为对本发明的限制。 14: Injection reservoir; 15: Injection; 16: Elastomeric layer; 17: Piston; 18: Threaded connection; 19: Bent section. detailed description The embodiments of the present invention are described in detail below, and the examples of the embodiments are illustrated in the drawings, wherein the same or similar reference numerals are used to refer to the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the drawings are intended to be illustrative of the invention and are not to be construed as limiting.
在本发明的描述中， 需要理解的是， 术语"上"、 "下"、 "前"、 "后"、 "左"、 "右" 、 "顶" 、 "底" 、 "内" 、 "外" 等指示的方位或位置关系为基于附图所示 的方位或位置关系， 仅是为了便于描述本发明和简化描述， 而不是指示或暗示所指的 装置或元件必须具有特定的方位、 以特定的方位构造和操作， 因此不能理解为对本发 明的限制。 此外， 术语 "第一" 、 "第二 " 仅用于描述目的， 而不能理解为指示或暗 示相对重要性或者隐含指明所指示的技术特征的数量。 由此， 限定有 "第一" 、 "第 二" 的特征可以明示或者隐含地包括一个或者更多个该特征。 在本发明的描述中， 除 非另有说明， "多个" 的含义是两个或两个以上。  In the description of the present invention, it is to be understood that the terms "upper", "lower", "previous", "rear", "left", "right", "top", "bottom", "inner", " The orientation or positional relationship of the "indicative" is based on the orientation or positional relationship shown in the drawings, and is merely for the convenience of the description of the present invention and the simplified description, rather than indicating or implying that the device or component referred to has a specific orientation, The specific orientation and operation are not to be construed as limiting the invention. Moreover, the terms "first" and "second" are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, features defining "first" and "second" may include one or more of the features, either explicitly or implicitly. In the description of the present invention, the meaning of "plurality" is two or more unless otherwise stated.
在本发明的描述中， 需要说明的是， 除非另有明确的规定和限定， 术语 "安装" 、 "相连" 、 "连接" 应做广义理解， 例如， 可以是固定连接， 也可以是可拆卸连接， 或一体地连接； 可以是机械连接， 也可以是电连接； 可以是直接相连， 也可以通过中 间媒介间接相连， 可以是两个元件内部的连通。 对于本领域的普通技术人员而言， 可 以具体情况理解上述术语在本发明中的具体含义。  In the description of the present invention, it should be noted that the terms "installation", "connected", and "connected" should be understood broadly, and may be either fixed or detachable, unless explicitly stated or defined otherwise. Connected, or connected integrally; can be mechanical or electrical; can be directly connected, or indirectly connected through an intermediate medium, can be the internal communication of the two components. The specific meaning of the above terms in the present invention can be understood in the specific case for those skilled in the art.
下面参考图 1-图 9描述根据本发明第一方面实施例的一种一次性多针管注射针头。 根据本发明实施例的一次性多针管注射针头， 包括： 针座 1、 定位结构、 针管固定 件 9、 和多根针管 2， 如图 1所示， 针座 1形成为中空的柱形筒 5， 针座 1的下端敞开 且上端具有顶盖 3， 顶盖 3上具有通孔 4， 定位结构设在顶盖 3上， 针管固定件 9由定 位结构定位， 针管 2穿过针管固定件 9且固定在针管固定件 9上， 针管 2的下端通过通 孔 4伸入柱形筒 5内用于剌入注射液存储器取液，针管 2的上端向上延伸用于穿剌皮肤并 注射， 多根针管 2彼此间隔开分布， 当然， 本实施例中针管 2 的数目不限于三个， 可 以为两个、 四个或者更多数目， 针管 2 的分布不限于阵列式的排列， 只要能分散地设 置在针管固定件 9上即可。 在一个可选的示例中， 多根针管 2排列成一维阵列， 而在 另一个可选的示例中， 多根针管 2排列成平面二维阵列。  A disposable multi-needle injection needle according to an embodiment of the first aspect of the present invention will now be described with reference to Figs. A disposable multi-needle injection needle according to an embodiment of the present invention includes: a needle hub 1, a positioning structure, a needle tube fixing member 9, and a plurality of needle tubes 2, as shown in Fig. 1, the needle holder 1 is formed as a hollow cylindrical barrel 5 The lower end of the needle hub 1 is open and the top end has a top cover 3, and the top cover 3 has a through hole 4, the positioning structure is disposed on the top cover 3, the needle tube fixing member 9 is positioned by the positioning structure, and the needle tube 2 passes through the needle tube fixing member 9 and The needle tube 2 is fixed on the needle tube fixing member 9, and the lower end of the needle tube 2 is inserted into the cylindrical barrel 5 through the through hole 4 for taking in the injection liquid to take the liquid. The upper end of the needle tube 2 is extended upward for the skin to be injected and injected, and the plurality of needle tubes are inserted. 2 is spaced apart from each other. Of course, the number of the needle tubes 2 in the embodiment is not limited to three, and may be two, four or more. The distribution of the needle tubes 2 is not limited to the array arrangement, as long as they are discretely arranged. The needle tube fixing member 9 can be used. In an alternative example, the plurality of needle tubes 2 are arranged in a one-dimensional array, and in another alternative example, the plurality of needle tubes 2 are arranged in a planar two-dimensional array.
每根针管的上端和下端均具有针尖， 两端的针尖结构可以不同， 其中位于顶盖 3 上方的针尖用于剌入皮肤与注射， 置于柱状筒 5 内的针尖用于剌入注射液存储器以便 提取药液。  The upper end and the lower end of each needle tube have a needle tip, and the needle tip structure at both ends may be different. The needle tip located above the top cover 3 is used for breaking into the skin and the injection, and the needle tip placed in the column barrel 5 is used for breaking into the injection liquid storage so as to be Extract the liquid.
根据本发明的一次性多针管注射针头， 通过将多根针管 2分散地设在针管固定件 9 上， 针管固定件 9又通过定位结构稳固地设置在针座 1的顶盖 3上， 从而形成了阵列 式多针管注射针头， 通过这种针头， 可以将一定剂量的胰岛素分散地同时注入皮下， 剌入力小， 注射时间短， 有利于胰岛素的快速吸收而不易漏液， 避免了单根针管注射 胰岛素积聚在注射部位时间过长导致皮下脂肪增生而产生硬结的现象， 注射时， 可以 垂直注射， 使用方便。 According to the disposable multi-needle injection needle of the present invention, by disposing a plurality of needle tubes 2 on the needle tube fixing member 9, the needle tube fixing member 9 is stably disposed on the top cover 3 of the needle holder 1 by a positioning structure, thereby forming An array of multi-needle injection needles through which a dose of insulin can be dispensed into the skin simultaneously, The small insertion force and short injection time are beneficial to the rapid absorption of insulin and are not easy to leak. It avoids the phenomenon that the injection of insulin in a single needle tube is too long at the injection site to cause subcutaneous fat hyperplasia and induration. When injected, it can be injected vertically. Easy to use.
在一些实施例中， 针管固定件 9包括： 基板部 7， 基板部 7定位在定位结构中， 其 中多根针管 2均穿过基板部 7并固定在基板部 7上， 如图 3所示， 基板部 7形成为平 板或曲面板。  In some embodiments, the needle holder 9 includes: a substrate portion 7 positioned in the positioning structure, wherein the plurality of needle tubes 2 pass through the substrate portion 7 and are fixed to the substrate portion 7, as shown in FIG. The substrate portion 7 is formed as a flat plate or a curved panel.
如图 1和图 2所示， 针管固定件 9还包括： 填充部分 10， 填充部分 10连接在基板部 7的下端， 填充部分 10位于通孔 4内或穿过通孔 4， 针管 2穿过基板部 7与填充部分 10并 固定在基板部 7与填充部分 10上。 如图 1所示， 针管固定件 9为一凸形结构， 包括连为一 体的基板部 7和填充部分 10， 基板部 7位于顶盖 3上方， 填充部分 10穿过通孔 4， 由于针 管通常很细且位于柱状筒内的部分较长， 通过填充部分 10可以增大针管 2与针管固定件 9 的接触长度， 并有效减小在柱状筒 5内露出的针管 2的长度， 从而使针管 2比较稳固且机 械强度进一步提高以利于剌入注射液存储器取液，当然该填充部分 10的长度应不会影响针 管 2取液。 可选地， 基板部 7和填充部分 10采用聚合物一体成型。 进一步地， 基板部 7和 填充部分 10采用树脂一体成型， 如采用环氧树脂可将基板部 7和填充部分 10—体成型并 同时可将多根针管 2按照设定分布牢固的固定于其中。  As shown in FIGS. 1 and 2, the needle tube fixing member 9 further includes: a filling portion 10 connected to the lower end of the substrate portion 7, and the filling portion 10 is located in or through the through hole 4, and the needle tube 2 passes through The substrate portion 7 and the filling portion 10 are fixed to the substrate portion 7 and the filling portion 10. As shown in Fig. 1, the needle tube fixing member 9 is a convex structure including an integrated substrate portion 7 and a filling portion 10, the substrate portion 7 is located above the top cover 3, and the filling portion 10 passes through the through hole 4, since the needle tube is usually The portion which is very thin and located in the cylindrical barrel is long, and the length of contact between the needle tube 2 and the needle tube fixing member 9 can be increased by the filling portion 10, and the length of the needle tube 2 exposed in the cylindrical barrel 5 can be effectively reduced, thereby making the needle tube 2 It is relatively stable and the mechanical strength is further improved to facilitate the infusion into the injection reservoir. Of course, the length of the filling portion 10 should not affect the withdrawal of the needle tube 2. Alternatively, the substrate portion 7 and the filling portion 10 are integrally molded with a polymer. Further, the substrate portion 7 and the filling portion 10 are integrally molded with a resin, and the substrate portion 7 and the filling portion 10 can be integrally molded by using an epoxy resin, and at the same time, the plurality of needle tubes 2 can be firmly fixed therein in accordance with a set distribution.
在一些可选的示例中，定位结构包括：定位夹壁 6，定位夹壁 6设在顶盖 3的上表面上。 可选地， 例如如图 1所示， 定位夹壁 6的内表面具有凹槽 62， 其中基板部 7的边缘容纳在 凹槽内。 可选地， 如图 1和图 2所示， 定位夹壁上 6设有用于卡固基板部 7的卡凸 61， 卡 凸 61可以与顶盖 3之间限定出上述凹槽 62， 以便卡固基板部 7。 这样， 直接将针管固定件 ***定位夹壁 6内通过卡凸 61和凹槽 62即可固定， 无需粘结、 固化等工序， 使得组装工 艺变得非常简单、 可大幅度提高成品率并降低成本。  In some optional examples, the positioning structure includes a positioning clip wall 6, and a positioning clip wall 6 is provided on the upper surface of the top cover 3. Alternatively, for example, as shown in Fig. 1, the inner surface of the positioning wall 6 has a recess 62 in which the edge of the base portion 7 is accommodated. Optionally, as shown in FIG. 1 and FIG. 2, the positioning clip wall 6 is provided with a card protrusion 61 for fastening the substrate portion 7. The card protrusion 61 can define the groove 62 between the top cover 3 for the card. The substrate portion 7 is fixed. In this way, the needle tube fixing member can be directly inserted into the positioning clip wall 6 to be fixed by the card protrusion 61 and the groove 62, and the processes such as bonding and curing are not required, so that the assembly process becomes very simple, the yield can be greatly improved, and the cost can be reduced. .
如图 2所示， 多根针管 2排成一列， 针管固定件 9变成倒 L形， 即使一部分定位夹壁 6 中没有设置凹槽 62和卡凸 61也能够将针管固定件 9牢固地固定， 另外还可以采用结构胶 黏剂进一步增加固定强度。 进一步地， 如图 4所示， 本实施例中的针管固定件 9也可以有 其他变形， 其基板部 7可以由聚合物如塑料板和结构胶黏剂制成， 塑料板中与针管 2连接 的部位填充有结构胶黏剂， 针管固定件 9的填充部分 10的材料为结构胶黏剂。  As shown in Fig. 2, a plurality of needle tubes 2 are arranged in a row, and the needle tube fixing member 9 is inverted L-shaped, and the needle tube fixing member 9 can be firmly fixed even if a part of the positioning clip wall 6 is not provided with the recess 62 and the tab protrusion 61. In addition, structural adhesives can be used to further increase the fixing strength. Further, as shown in FIG. 4, the needle tube fixing member 9 in this embodiment may have other deformations, and the substrate portion 7 may be made of a polymer such as a plastic plate and a structural adhesive, and the plastic plate is connected to the needle tube 2. The portion is filled with a structural adhesive, and the material of the filling portion 10 of the needle holder 9 is a structural adhesive.
本发明中的针管 2 可以选择不锈钢等医用金属针管， 结构胶黏剂可选用环氧树脂或者 其他材料类型的结构胶黏剂， 环氧树脂结构粘胶剂可以与包括金属针管 2在内的多种材料 形成牢固的粘结。 针座 1可以选用聚丙烯、 聚乙烯、 聚氯乙烯等塑料制备。 其中， 定位夹 壁 6可以与针座 1采用注塑法一体制作。 当然， 定位夹壁 6也可以与针管固定件 9一体制 作， 此时需在针座 1的顶盖 3上设置定位槽 （图未示出）， 然后将其固定在该定位槽中。 如图 8和图 9所示， 顶盖 3上的定位夹壁 6可以采用多种形状， 例如定位夹壁 6在顶 盖 3上的投影形成为圆形、 椭圆形、 或多边形。 在一个可选的示例中， 定位夹壁 6既形成 为环形夹壁， 而在另一个可选的示例中， 定位夹壁 6形成为沿柱形筒 1的周向彼此间隔开 的多个子夹壁部 （图未示出）。 柱状筒 5通常可以采用与现有市售注射笔针头类似的圆形， 但也可以是多边形等其他形状， 只要能够稳固地套在注射液存储器 14接口上即可。 The needle tube 2 of the present invention can be selected from medical metal needle tubes such as stainless steel, and the structural adhesive can be selected from epoxy resin or structural adhesives of other material types, and the epoxy resin structure adhesive can be combined with metal needle tubes 2, The materials form a strong bond. The needle holder 1 can be made of plastic such as polypropylene, polyethylene or polyvinyl chloride. Wherein, the positioning clip wall 6 can be integrally formed with the needle holder 1 by injection molding. Of course, the positioning wall 6 can also be integrally formed with the needle holder 9 in which a positioning groove (not shown) is provided on the top cover 3 of the needle holder 1 and then fixed in the positioning groove. As shown in FIGS. 8 and 9, the positioning wall 6 on the top cover 3 can take a variety of shapes, for example, the projection of the positioning wall 6 on the top cover 3 is formed into a circular shape, an elliptical shape, or a polygonal shape. In an alternative example, the positioning clip wall 6 is formed both as an annular clamping wall, while in another alternative example, the positioning clip wall 6 is formed as a plurality of sub-clips spaced apart from one another in the circumferential direction of the cylindrical barrel 1. Wall (not shown). The cylindrical barrel 5 can generally adopt a circular shape similar to a conventional commercially available injection pen needle, but may be other shapes such as a polygonal shape as long as it can be firmly fitted over the interface of the injection liquid reservoir 14.
根据本发明的一些实施例， 顶盖 3上具有彼此间隔开的多个通孔 4， 其中多根针管 2 分别一一对应地穿过通孔 4固定。如图 5所示， 在针座 1的顶盖 3上设置三个通孔 4阵列， 采用环氧树脂结构胶黏剂将三根两端均具有针尖的不锈钢针管 2分别直接固定在具有通孔 4阵列的针座顶盖 3上，针管固定件 9的基板部 7和填充部分 10均为环氧树脂结构胶黏剂， 组装时可能会使基板部 7的顶部凸出定位夹壁 6并覆盖在定位夹壁 6的顶部， 由于本实施 例中针管固定件 9均是通过将结构胶黏剂填充在三个通孔 4中和针座顶盖 3上形成， 针管 固定件 9可以与通孔 4内壁和定位夹壁 6很好地粘结， 所以不需要在定位夹壁 6上设置卡 凸 61和凹槽 62。  According to some embodiments of the present invention, the top cover 3 has a plurality of through holes 4 spaced apart from each other, wherein the plurality of needle tubes 2 are fixed in one-to-one correspondence through the through holes 4, respectively. As shown in FIG. 5, an array of three through holes 4 is arranged on the top cover 3 of the needle holder 1, and three stainless steel needle tubes 2 each having a needle tip at both ends are directly fixed to the through hole 4 by using an epoxy resin adhesive. On the needle top cover 3 of the array, the substrate portion 7 and the filling portion 10 of the needle tube fixing member 9 are epoxy resin structural adhesives, and the top portion of the substrate portion 7 may be protruded from the positioning wall 6 and covered in the assembly. The top of the clamping wall 6 is positioned. Since the needle fixing member 9 in the embodiment is formed by filling the structural adhesive in the three through holes 4 and the needle cover 3, the needle fixing member 9 and the through hole 4 can be formed. The inner wall and the positioning wall 6 are well bonded, so that it is not necessary to provide the tab 61 and the recess 62 on the positioning wall 6.
进一步地， 如图 6所示， 为了提高针管 2在针管固定件 9上的稳固性， 针座顶盖 3向 下延伸出凸起部 31， 针管固定件 9在针座顶盖 3上的基板部 7与位于通孔 4和凸起部 31 内的填充部分 10连为一体。  Further, as shown in FIG. 6, in order to improve the stability of the needle tube 2 on the needle tube fixing member 9, the needle holder top cover 3 extends downwardly from the convex portion 31, and the substrate of the needle tube fixing member 9 on the needle holder top cover 3 The portion 7 is integrally formed with the filling portion 10 located in the through hole 4 and the boss portion 31.
可选地， 如图 7所示， 针座顶盖 3上的通孔 4可以为锥形孔， 即通孔 4的横截面从上 端 （例如图 7中的上端） 向下端 （例如图 7中的下端）逐渐增大， 在另一个可选的示例中， 通孔 4也可为直孔， 即通孔 4的横截面从上端向下端恒定。 其中， 可以采用环氧树脂结构 胶黏剂从针座顶盖 3的上面固定针管 2， 也可以采用环氧树脂结构胶黏剂从针管顶盖 3的 下面固定针管 2， 环氧树脂结构胶黏剂凝固后即形成针管固定件 9， 凸起部 31同样对针管 固定件 9起限定作用。  Optionally, as shown in FIG. 7, the through hole 4 in the needle cover 3 may be a tapered hole, that is, the cross section of the through hole 4 is from the upper end (for example, the upper end in FIG. 7) to the lower end (for example, in FIG. 7). The lower end) is gradually increased. In another alternative example, the through hole 4 may also be a straight hole, that is, the cross section of the through hole 4 is constant from the upper end to the lower end. Wherein, the epoxy tube structural adhesive may be used to fix the needle tube 2 from the upper surface of the needle seat top cover 3, or the epoxy resin structure adhesive may be used to fix the needle tube 2 from the lower surface of the needle tube top cover 3, and the epoxy resin structure is adhesive. After the agent is solidified, the needle tube fixing member 9 is formed, and the boss portion 31 also serves to define the needle tube fixing member 9.
如图 6和图 7所示， 为了提高注射液在体内的分散性以利于吸收和减小药液在皮下局 部的积聚时间， 可以设置针管 2伸出顶盖 3上定位夹壁 6的针尖出液口的法线方向可以不 相同。至少两根针管 2的上端的针尖的形状和 /或水平高度不相等， 例如针管 2伸出定位夹 壁 6用于穿剌皮肤并注射的部分的长度可以不相等。 针管 2两端的针尖形状与尺寸也可以 不同， 但必须结构坚固、 便于穿剌、 且不易堵塞管道。  As shown in FIG. 6 and FIG. 7, in order to improve the dispersibility of the injection solution in the body to facilitate absorption and reduce the accumulation time of the liquid in the subcutaneous portion, the needle tube 2 may be disposed to protrude from the needle tip of the positioning wall 6 of the top cover 3. The normal direction of the liquid port can be different. The shape and/or the level of the tips of the upper ends of at least two of the needle tubes 2 are not equal, for example, the length of the portion of the needle tube 2 extending out of the positioning clip wall 6 for piercing the skin and being injected may be unequal. The shape and size of the needle tip at both ends of the needle tube 2 can also be different, but it must be structurally strong, easy to wear, and difficult to block the pipe.
本发明实施例中， 针管阵列可以是排成一排的一维阵列， 也可以是平面二维阵列。 为 了便于插拔操作， 可以在柱状筒 5的外表面设置防滑纹， 甚至在针管保护套 11的外表面也 可以设置防滑纹。 由此， 使用时可以直接***或拔出， 适用性强， 使用方便。 在针座保护 套 12的内壁上还可以设置凸起以便更容易取出针座 1。 根据注射液存储器 14接口的结构， 还可以在柱状筒 5的筒壁上设置与其相应的螺纹或固定卡口， 用于与注射液储存器可拆卸 连接。 In the embodiment of the present invention, the needle tube array may be a one-dimensional array arranged in a row or a planar two-dimensional array. In order to facilitate the insertion and removal operation, an anti-slip pattern may be provided on the outer surface of the cylindrical barrel 5, and an anti-slip pattern may be provided even on the outer surface of the needle tube protective cover 11. Therefore, it can be directly inserted or pulled out during use, and has strong applicability and convenient use. A projection may also be provided on the inner wall of the hub protector 12 to make it easier to remove the hub 1. According to the structure of the interface of the injection reservoir 14, it is also possible to provide a corresponding thread or a fixed bayonet on the wall of the cylindrical barrel 5 for detachable from the injection reservoir. Connected.
进一步地， 针管 2的外径为 60um-450um， 内径为 30um_250um， 伸出于定位夹壁 6用于 穿剌注射的针管 2长度为 0. 2mm-4. 0mm, 位于柱状筒 5内用于从注射液储存器中提取注射 液的针管长度为 0. 5mm-15mm。 由于采用的针管很细和用于剌入注射的针管长度很短， 不必 考虑捏皮等注射手法就可以在手臂、 大腿、 腹部等有效注射部位采用垂直注射， 注射针管 2 全部剌入皮下即可， 使用起来非常方便， 便于实施轮换部位注射而不会有肌肉注射的风 险， 能轻松实现微痛甚至无疼注射， 进而明显提高患者的注射依从性与治疗效果。  2mm-4. 0mm, located in the cylindrical barrel 5 for use in the cylindrical tube 5, the outer diameter of the needle tube 2 is 60um-450um, the inner diameter is 30um_250um, and the length of the needle tube 2 is 0. 2mm-4. 5毫米-15毫米。 The length of the needle is 0. 5mm-15mm. Since the needle tube used is very thin and the length of the needle tube for injecting the injection is very short, it is possible to use a vertical injection in an effective injection site such as an arm, a thigh or an abdomen without taking into consideration an injection method such as kneading, and the injection needle 2 can be completely subcutaneously injected into the skin. It is very convenient to use, and it is easy to implement the injection of the rotating part without the risk of intramuscular injection. It can easily achieve slight pain or even no painful injection, thereby obviously improving the patient's compliance and treatment effect.
针管 2可以采用不锈钢等多种医用金属材料制造， 针座 1可以选用聚丙烯、 聚乙烯等 塑料制备。  The needle tube 2 can be made of various medical metal materials such as stainless steel, and the needle holder 1 can be made of plastic such as polypropylene or polyethylene.
上述注射针头除可用于与现有胰岛素笔相结合使用外， 如选择合适的接口结构还可与 现有或未来其它药物的注射器或注射液存储器结合使用， 并且由于本发明柱状筒中有多个 针管用作取液口， 该多个取液口可分别和不同药物的注射液存储器结合使用。  The above-mentioned injection needle can be used in combination with an existing insulin pen, and can also be used in combination with an existing or future syringe or injection reservoir of other drugs, and a plurality of syringes in the column of the present invention. Used as a liquid intake port, the plurality of liquid intake ports can be used in combination with injection solutions of different drugs.
在根据本发明的一些实施例中， 如图 1所示， 一次性多针管注射针头还可以包括针座 保护套 12和针管保护套 11。  In some embodiments according to the present invention, as shown in Figure 1, the disposable multi-needle injection needle can also include a needle guard 12 and a needle guard 11.
针座 1的顶盖 3上的定位结构外套设有针管保护套 11，针座 1和针管保护套 11外套设 有针座保护套 12， 针座保护套 12的下端敞开且由密封材料层 13封闭。 密封材料可选用密 封透析纸等医用材料。 针管保护套 11和针座保护套 12可以选用多种材料如聚丙烯、 聚氯 乙烯等塑料制备， 通过针管保护套 11可以防止针头在储运过程中折弯损坏针管 2， 通过设 置针座保护套 12和密封材料层 13， 在针头经过环氧乙垸等消毒灭菌后就可以保证针管在 使用有效期内一直处于清洁无菌的环境中。  The positioning structure on the top cover 3 of the needle holder 1 is provided with a needle protection sleeve 11, and the needle holder 1 and the needle protection sleeve 11 are provided with a needle holder 12, and the lower end of the needle holder 12 is opened and the sealing material layer 13 is provided. Closed. The sealing material may be made of medical materials such as sealed dialysis paper. The needle protection sleeve 11 and the needle holder 12 can be prepared by using various materials such as polypropylene, polyvinyl chloride, etc. The needle protection sleeve 11 can prevent the needle from being bent and damaged during storage and transportation, and the needle holder can be protected by setting the needle holder. The sleeve 12 and the sealing material layer 13 ensure that the needle tube is kept in a clean and sterile environment for a period of use after the needle is sterilized by epoxy oxime or the like.
下面参考图 1-图 9描述根据本发明多个具体实施例的一次性多针管注射针头。  A disposable multi-needle injection needle in accordance with various embodiments of the present invention is described below with reference to Figures 1-9.
实施例一，  Embodiment 1,
如图 1所示， 在本实施例中， 注射针头包括针座 1、 三根针管 2、 针管固定件 9、 定位 夹壁 6、 针管保护套 11、 针座保护套 12和密封材料层 13。 该针座 1是为一端开口、 另一 端具有顶盖 3的柱状筒 5， 针座 1的顶盖 3上开设有一个通孔 4。针管 2穿过针座 1的顶盖 3的通孔 4并且通过针管固定件 9阵列式地固定设置在针座 1的顶盖 3上， 针管 2的两端 均具有针尖， 两端的针尖结构可以不同， 其中位于顶盖 3上方的针尖用于剌入皮肤与注射， 置于柱状筒 5内的针尖用于剌入注射液存储器以便提取药液。  As shown in Fig. 1, in the present embodiment, the injection needle includes a needle holder 1, three needle tubes 2, a needle tube fixing member 9, a positioning wall 6, a needle tube protective sleeve 11, a needle holder 12 and a sealing material layer 13. The needle holder 1 is a cylindrical barrel 5 having an opening at one end and a top cover 3 at the other end, and a through hole 4 is formed in the top cover 3 of the needle holder 1. The needle tube 2 passes through the through hole 4 of the top cover 3 of the needle holder 1 and is fixedly disposed on the top cover 3 of the needle holder 1 by the needle tube fixing member 9. The needle tube 2 has a needle tip at both ends, and the needle tip structure at both ends can be Differently, the needle tip located above the top cover 3 is used for breaking into the skin and the injection, and the needle tip placed in the cylindrical barrel 5 is used for breaking into the injection liquid reservoir for extracting the medical liquid.
针管固定件 9为一凸形结构， 包括连为一体的基板部 7和填充部分 10， 基板部 7位于 顶盖 3上方， 填充部分 10穿过通孔 4， 由于针管通常很细且位于柱状筒内的部分较长， 通 过填充部分 10可以增大针管 2与针管固定件 9的接触长度，并有效减小在柱状筒 5内露出 的针管 2的长度， 从而使针管 2比较稳固且机械强度进一步提高以利于剌入注射液存储器 取液， 当然该填充部分 10的长度应不会影响针管 2取液； 基板部 7和填充部分 10采用聚 合物材料或结构粘胶剂一体制造。 The needle tube fixing member 9 is a convex structure including an integrated substrate portion 7 and a filling portion 10, the substrate portion 7 is located above the top cover 3, and the filling portion 10 passes through the through hole 4, since the needle tube is usually very thin and is located in the column tube The inner portion is longer, and the length of contact between the needle tube 2 and the needle tube fixing member 9 can be increased by the filling portion 10, and the length of the needle tube 2 exposed in the cylindrical barrel 5 can be effectively reduced, thereby making the needle tube 2 relatively stable and further mechanically strong. Increased to facilitate injection into the injection reservoir The liquid is taken, of course, the length of the filling portion 10 should not affect the liquid taking of the needle tube 2; the substrate portion 7 and the filling portion 10 are integrally manufactured using a polymer material or a structural adhesive.
顶盖 3上方设置有定位夹壁 6用于限定针管固定件 9的基板部 7的径向位置， 定位夹 壁 6的内壁具有卡凸 61和凹槽 62， 将基板部 7卡在凹槽 62中， 可以使针管固定件 9更加 稳固， 当然也可以使用结构胶黏剂将针管固定件 9的基板部 7粘结在针座 1顶盖 3上。  A positioning clip wall 6 is disposed above the top cover 3 for defining a radial position of the base portion 7 of the needle holder 9 , and an inner wall of the positioning wall 6 has a projection 61 and a recess 62 for engaging the substrate portion 7 in the recess 62 In this case, the needle tube fixing member 9 can be made more stable. Of course, the substrate portion 7 of the needle tube fixing member 9 can be bonded to the top cover 3 of the needle holder 1 by using a structural adhesive.
定位夹壁 6外壁上套设有针管保护套 11，在针管保护套 11和针座 1的外部可套设有针 座保护套 12; 针座保护套 12下部的开口处设置有密封材料层 13， 密封材料可选用密封透 析纸等医用材料。 然， 本实施例中针管 2的数目不限于三个， 可以为两个、 四个或者更多 数目， 针管 2的分布不限于阵列式的排列， 只要能分散地设置在针管固定件 9上即可。  A needle protection sleeve 11 is sleeved on the outer wall of the positioning wall 6 , and a needle protection sleeve 12 is sleeved on the outside of the needle protection sleeve 11 and the needle holder 1 ; a sealing material layer 13 is disposed at the opening of the lower portion of the needle holder 12 The sealing material can be selected from medical materials such as sealed dialysis paper. However, the number of the needle tubes 2 in the present embodiment is not limited to three, and may be two, four or more. The distribution of the needle tubes 2 is not limited to the array arrangement, as long as it can be dispersedly disposed on the needle tube fixing member 9, can.
根据本发明实施例的注射针头， 通过将针管 2分散地设置在材料为环氧树脂的针管固 定件 9上， 随后将针管固定件 9直接***定位夹壁 6内， 通过卡凸 61和凹槽 62结构即可 稳固地设置在针座 1的顶盖 3上， 从而形成了阵列式多针管 2注射针头， 无需粘结、 固化 等工序， 使得组装工艺变得非常简单、 可以明显提高成品率和大幅度降低成本。 通过这种 针头， 可以将一定剂量的胰岛素分散地同时注入皮下， 注射时间短， 有利于胰岛素的快速 吸收而不易漏液， 避免了单根针管注射胰岛素积聚在注射部位时间过长导致皮下脂肪增生 而产生硬结的现象， 注射时， 可以垂直注射， 使用方便； 本实施例只有三个针管与药液和 皮肤接触， 所以可以将针头中除针管外的其他部件的材料选择面大大拓宽， 结构与制造 工艺变得更加简单， 成本低廉， 针管可靠性高， 并且降低针头因个别针管 2堵塞而不能使 用的风险， 提高了注射的可靠性； 针管保护套 11和针座保护套 12可以选用多种材料如聚 丙烯、 聚氯乙烯等塑料制备， 通过针管保护套 11可以防止针头在储运过程中折弯损坏针管 2， 通过设置针座保护套 12和密封材料层 13， 在针头经过环氧乙垸等消毒灭菌后就可以保 证针管 2在使用有效期内一直处于清洁无菌的环境中。 实施例二，  According to the injection needle of the embodiment of the present invention, the needle tube 2 is dispersedly disposed on the needle tube fixing member 9 made of epoxy resin, and then the needle tube fixing member 9 is directly inserted into the positioning clip wall 6, through the card protrusion 61 and the groove The structure of the 62 can be stably disposed on the top cover 3 of the needle holder 1, thereby forming an array type multi-needle tube 2 injection needle, which does not require bonding, curing, etc., so that the assembly process becomes very simple, and the yield can be significantly improved. Significantly reduce costs. Through this kind of needle, a certain dose of insulin can be injected into the skin at the same time, and the injection time is short, which is beneficial to the rapid absorption of insulin and is not easy to leak, and avoids the excessive accumulation of insulin in a single needle tube at the injection site for a long time to cause subcutaneous fat hyperplasia. In the case of induration, it can be injected vertically and conveniently used. In this embodiment, only three needle tubes are in contact with the liquid medicine and the skin, so that the material selection surface of the needles other than the needle tube can be greatly broadened, the structure and The manufacturing process becomes simpler, the cost is lower, the reliability of the needle tube is high, and the risk that the needle cannot be used due to clogging of the individual needle tubes 2 is reduced, and the reliability of the injection is improved; the needle protection sleeve 11 and the needle seat protection sleeve 12 can be selected from various types. The material is prepared by plastics such as polypropylene and polyvinyl chloride. The needle protection sleeve 11 can prevent the needle from being bent and damaged during the storage and transportation process. By setting the needle seat cover 12 and the sealing material layer 13, the needle passes through the epoxy After disinfection and sterilization, the needle tube 2 can be guaranteed to be in use. Straight in a clean sterile environment. Embodiment 2,
如图 2所示， 在本实施例中的注射针头与实施例一中大致相同， 不同之处在于， 多根 针管排成一列， 针管固定件 9变成倒 L形， 即使一部分定位夹壁 6中没有设置卡凸 61和凹 槽 62也能够将针管固定件 9牢固的固定，另外还可以采用结构胶黏剂进一步增加固定强度。 实施例三，  As shown in Fig. 2, the injection needle in this embodiment is substantially the same as that in the first embodiment, except that a plurality of needle tubes are arranged in a row, and the needle tube fixing member 9 is inverted L-shaped even if a part of the positioning clip wall 6 is formed. The provision of the clip 61 and the recess 62 in the middle can also securely fix the needle holder 9 and further increase the fixing strength by using a structural adhesive. Embodiment 3,
如图 3所示， 在本实施例中的注射针头与实施例一中大致相同， 不同之处在于， 针管 固定件 9直接简化为基板部 7， 该基板部 7为平面板， 但也可以为曲面板。 实施例四， As shown in FIG. 3, the injection needle in the present embodiment is substantially the same as that in the first embodiment, except that the needle tube fixing member 9 is directly simplified to the substrate portion 7, which is a flat plate, but may be Curved panel. Embodiment 4,
如图 4所示， 在本实施例中的注射针头与实施例一中大致相同， 不同之处在于， 本实 施例中的针管固定件 9也可以有其他变形， 其基板部 7可以由聚合物如塑料板和结构胶黏 剂制成， 塑料板中与针管 2连接的部位填充有结构胶黏剂， 针管固定件 9的填充部分 10的 材料为结构胶黏剂。 实施例五，  As shown in FIG. 4, the injection needle in this embodiment is substantially the same as that in the first embodiment, except that the needle tube fixing member 9 in this embodiment may have other deformations, and the substrate portion 7 may be made of a polymer. The plastic sheet is made of a structural adhesive, and the material of the filling portion 10 of the needle fixing member 9 is a structural adhesive. Embodiment 5,
如图 5所示， 在本实施例中的注射针头与实施例一中大致相同， 不同之处在于， 针座 顶盖 3上通孔 4的数目、 针管固定件 9以及定位夹壁 6的结构。  As shown in Fig. 5, the injection needle in this embodiment is substantially the same as that in the first embodiment, except that the number of the through holes 4 in the needle hub top cover 3, the needle tube fixing member 9 and the structure of the positioning clip wall 6 are shown. .
具体而言， 如图 5所示， 在针座 1的顶盖 3上设置三个通孔 4阵列， 采用环氧树脂结 构胶黏剂将三根两端均具有针尖的不锈钢针管 2分别直接固定在具有通孔 4阵列的针座顶 盖 3上， 针管固定件 9的基板部 7和填充部分 10均为环氧树脂结构胶黏剂， 且基板部 7的 顶部凸出定位夹壁 6并覆盖在定位夹壁 6的顶部， 由于本实施例中针管固定件 9均是通过 将结构胶黏剂填充在三个通孔 4中和针座顶盖 3上形成， 针管固定件 9可以与通孔 4内壁 和定位夹壁 6很好地粘结， 所以不需要在定位夹壁 6上设置卡凸 61和凹槽 62。 实施例六，  Specifically, as shown in FIG. 5, an array of three through holes 4 is arranged on the top cover 3 of the needle holder 1, and three stainless steel needle tubes 2 each having a needle tip at both ends are directly fixed by an epoxy resin structural adhesive. On the needle top cover 3 having the array of through holes 4, the substrate portion 7 and the filling portion 10 of the needle tube fixing member 9 are epoxy resin structural adhesives, and the top portion of the substrate portion 7 protrudes from the positioning wall 6 and is covered by The top of the clamping wall 6 is positioned. Since the needle fixing member 9 in the embodiment is formed by filling the structural adhesive in the three through holes 4 and the needle cover 3, the needle fixing member 9 and the through hole 4 can be formed. The inner wall and the positioning wall 6 are well bonded, so that it is not necessary to provide the tab 61 and the recess 62 on the positioning wall 6. Embodiment 6,
如图 6所示， 在本实施例中的注射针头与实施例五中大致相同， 不同之处在于， 为了 提高针管 2在针管固定件 9上的稳固性， 可以在针座顶盖 3下表面向下延伸也设置限定针 管固定件 9的凸起部 31， 针管固定件 9在针座顶盖 3上的基板部 7与位于通孔 4和凸起部 31内的填充部分 10连为一体。  As shown in FIG. 6, the injection needle in this embodiment is substantially the same as that in the fifth embodiment, except that in order to improve the stability of the needle tube 2 on the needle tube fixing member 9, the lower surface of the needle holder top cover 3 may be provided. The boss portion 31 defining the needle tube fixing member 9 is also provided to extend downward, and the base plate portion 7 of the needle tube fixing member 9 on the needle holder top cover 3 is integrally connected with the filling portion 10 located in the through hole 4 and the boss portion 31.
实施例七， Embodiment 7,
如图 7所示， 针座顶盖 3上的通孔 4可以为直孔也可为锥形孔， 可以采用环氧树脂结 构胶黏剂从针座顶盖 3 的上面固定针管 2， 也可以采用环氧树脂结构胶黏剂从针管顶盖 3 的下面固定针管 2， 环氧树脂结构胶黏剂凝固后即形成针管固定件 9， 在针座 1顶盖 3的下 方设置凸起部 31， 该凸起部 31为针座 1顶盖 3上的锥形通孔 4阵列区域向下的延伸， 该 凸起部 31上的通孔 4为针座顶盖 3上通孔 4向下的延伸， 该凸起部 31同样对针管固定件 9起限定作用。 实施例八， 如图 8所示， 本实施例中的定位夹壁 6为方形结构， 即定位夹壁 6在顶盖 3上的投影 形成为方形。 实施例九， As shown in FIG. 7, the through hole 4 in the needle cover 3 can be a straight hole or a tapered hole, and the needle tube 2 can be fixed from the upper surface of the needle cover 3 by using an epoxy resin adhesive. The needle tube 2 is fixed from the lower surface of the needle cap 3 by using an epoxy resin structural adhesive. After the epoxy resin structure is solidified, the needle fixing member 9 is formed, and the convex portion 31 is disposed under the top cover 3 of the needle holder 1. The convex portion 31 extends downward from the array area of the tapered through holes 4 on the top cover 3 of the needle holder 1. The through hole 4 in the convex portion 31 is a downward extension of the through hole 4 in the needle cover 3 The boss 31 also serves to define the needle holder 9 . Embodiment 8 As shown in FIG. 8, the positioning clip wall 6 in this embodiment has a square structure, that is, the projection of the positioning clip wall 6 on the top cover 3 is formed into a square shape. Embodiment IX,
如图 9所示， 本实施例中的定位夹壁 6为圆筒形结构， 即定位夹壁 6在顶盖 3上的投 影形成为圆形。 根据本发明实施例的一次性多针管注射针头， 具有以下优点：  As shown in Fig. 9, the positioning wall 6 in this embodiment has a cylindrical structure, that is, the projection of the positioning wall 6 on the top cover 3 is formed into a circular shape. A disposable multi-needle injection needle according to an embodiment of the present invention has the following advantages:
第一， 使多个针管直接穿过所述针座顶盖上的通孔并且通过所述针管固定件分散地固 定设置在所述针座的顶盖上， 针管的两端均有针尖， 分别用于取液和注射， 这样可以将一 定剂量的胰岛素同时分散地注入皮下， 注射时间短， 有利于胰岛素的吸收， 不漏液， 能有 效避免注射部位皮下脂肪增生而产生硬结。  First, a plurality of needle tubes are directly passed through the through holes in the top cover of the needle holder and are fixedly disposed on the top cover of the needle holder by the needle tube fixing member, and the needle ends are provided at both ends of the needle tube, respectively It is used for liquid extraction and injection, so that a certain dose of insulin can be injected into the skin at the same time. The injection time is short, which is beneficial to the absorption of insulin and does not leak liquid. It can effectively avoid subcutaneous fat hyperplasia at the injection site and produce induration.
第二， 这种一次性多针管注射针头的结构和制造工艺简单， 成本低廉， 并且降低了针 头因单根针管堵塞而不能使用的风险， 提高了注射的可靠性。  Second, the disposable multi-needle injection needle has a simple structure and a simple manufacturing process, and is low in cost, and reduces the risk that the needle cannot be used due to clogging of a single needle tube, thereby improving the reliability of the injection.
第三， 由于针管伸出所述定位结构用于穿剌皮肤并注射的部分的长度较短， 可以不必 考虑捏皮、 针管倾斜等常规注射技巧， 能够非常方便的在手臂、 大腿、 腹部等多个有效注 射部位注射而不必担心造成肌肉注射。 下面参考图 10描述根据本发明第二方面实施例的一种预灌装注射器，包括根据上述第 一方面实施例的一次性多针管注射针头， 以及注射液存储器 14。  Thirdly, since the needle tube protrudes from the positioning structure for piercing the skin and the length of the injected portion is short, conventional injection techniques such as pinching and needle tilting can be omitted, and the arm, the thigh, the abdomen, etc. can be conveniently used. An effective injection site is injected without fear of causing intramuscular injection. A prefilled syringe according to an embodiment of the second aspect of the present invention, including a disposable multi-needle injection needle according to the above-described first embodiment, and an injectable reservoir 14 will be described with reference to FIG.
注射液储存器 14与柱状筒 5的内壁相配合且可相对移动， 注射存储器包括筒体、 弹性 体层 16和活塞 17， 筒体的顶部和底部均设有开口， 筒体顶部的开口与针管 2相对应， 弹 性体层 16位于筒体的顶部用于密封筒体顶部的开口， 同时， 弹性体层 16易于被柱状筒 5 内针管 2的针尖剌穿， 一般弹性体层 16的材料选用橡胶， 活塞 17设置在筒体的底部， 活 塞 17和弹性体层 16之间的空间存储有注射液 15， 筒体底部的开口方便按压活塞 17， 注射 液存储器 14与柱状筒 5连接， 具体地讲， 筒体的底端还一体连接有弯折段 19， 弯折段 19 的自由端与柱状筒 5的外壁上均具有相应的螺纹连接区 18， 注射液存储器 14与柱状筒 5 在该螺纹连接区 18连接。 当然弯折段 19的自由端与柱状筒 5的外壁上也可以设置有相配 合的卡口结构， 两者也可以采取卡口卡接。 柱状筒和注射液存储器的筒体均由常规的聚丙 烯等透明材料制成， 这样注射液存储器的筒体上可以设置便于观测的容量刻度。  The injection reservoir 14 cooperates with and is relatively movable with the inner wall of the cylindrical barrel 5. The injection reservoir includes a barrel, an elastomer layer 16 and a piston 17, and the top and bottom of the barrel are provided with openings, the opening of the barrel and the needle tube Correspondingly, the elastomer layer 16 is located at the top of the cylinder for sealing the opening of the top of the cylinder. At the same time, the elastomer layer 16 is easily pierced by the needle tip of the needle tube 2 in the cylindrical barrel 5. Generally, the material of the elastomer layer 16 is rubber. The piston 17 is disposed at the bottom of the cylinder, and the space between the piston 17 and the elastomer layer 16 stores the injection liquid 15. The opening at the bottom of the cylinder facilitates pressing the piston 17, and the injection liquid reservoir 14 is connected to the column cylinder 5, specifically The bottom end of the cylinder is also integrally connected with a bent portion 19, and the free end of the bent portion 19 and the outer wall of the cylindrical barrel 5 have corresponding threaded connection portions 18, and the injection liquid reservoir 14 and the cylindrical barrel 5 are connected thereto. Zone 18 is connected. Of course, the free end of the bending section 19 and the outer wall of the cylindrical barrel 5 may also be provided with a matching bayonet structure, and the two may also be snap-fitted by the bayonet. The cylinders of the cylindrical barrel and the injection reservoir are each made of a transparent material such as conventional polypropylene, so that the volume of the volume of the injection reservoir can be easily viewed.
使用时， 可以先手动旋转将注射液储存器 14转出螺纹连接区 18或固定卡口， 之后注 射液存储器 14和一次性多针管注射针头的柱状筒 5可以相对滑动，此时按压注射液储存器 朝向一次性多针管注射针头移动， 并将针头剌穿顶端的弹性体层 16直至接触注射液 15， 最后推动底端的活塞 17挤压注射液 15通过针管 2实施注射。 本实施例通过将一次性多针 管注射针头与注射液储存器组合在一起， 使用方便快捷， 装置小巧轻便， 并且不限于胰岛 素注射， 也可以适用于其他药物注射， 应用更为广泛。 In use, the injection reservoir 14 can be manually rotated out of the threaded connection area 18 or the fixed bayonet, and then the injectable reservoir 14 and the cylindrical barrel 5 of the disposable multi-needle injection needle can be relatively slid, and the injection liquid is stored at this time. Device The needle is moved toward the disposable multi-needle injection needle, and the needle is pierced through the top elastic layer 16 until it contacts the injection liquid 15, and finally the bottom end of the piston 17 is squeezed through the injection liquid 15 to perform the injection through the needle tube 2. In this embodiment, by combining the disposable multi-needle injection needle with the injection reservoir, the use is convenient and quick, the device is small and light, and is not limited to insulin injection, and can also be applied to other drug injections, and is widely used.
在制造时， 可以将一次性多针管注射针头和注射液储存器组装成一体， 并一同被消毒 封闭在针座保护套 12内， 也可以平时将一次性多针管注射针头和注射液储存器分别存放， 使用时再组装成一体。 上述实施例的各种产品， 均可采用现有成熟的加工工艺和规定的常 规或新型医用材料制造， 制造工艺简单， 成本低廉。  At the time of manufacture, the disposable multi-needle injection needle and the injection reservoir can be assembled into one body, and are simultaneously sterilized and enclosed in the needle holder 12, or the disposable multi-needle injection needle and the injection reservoir can be separately used. Store and assemble into one when using. The various products of the above embodiments can be manufactured by using existing mature processing techniques and prescribed conventional or new medical materials, and the manufacturing process is simple and the cost is low.
根据本发明实施例的预灌装注射器， 将上述一次性多针管注射针头与注射液储存器组 合在一起， 使用更加方便快捷， 装置小巧轻便， 并且不限于胰岛素注射， 也可以适用于其 他药物注射， 应用前景更为广泛。  According to the prefilled syringe of the embodiment of the present invention, the above-mentioned disposable multi-needle injection needle and the injection liquid reservoir are combined, which is more convenient and quick to use, the device is small and light, and is not limited to insulin injection, and can also be applied to other drug injections. , the application prospects are more extensive.
在本说明书的描述中，参考术语"一个实施例"、 "一些实施例"、 "示意性实施例"、 "示 例"、 "具体示例"、 或 "一些示例"等的描述意指结合该实施例或示例描述的具体特征、 结 构、 材料或者特点包含于本发明的至少一个实施例或示例中。 在本说明书中， 对上述术语 的示意性表述不一定指的是相同的实施例或示例。 而且， 描述的具体特征、 结构、 材料或 者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。  In the description of the present specification, the description with reference to the terms "one embodiment", "some embodiments", "illustrative embodiment", "example", "specific example", or "some examples", etc. Particular features, structures, materials or features described in the examples or examples are included in at least one embodiment or example of the invention. In the present specification, the schematic representation of the above terms does not necessarily mean the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in a suitable manner in any one or more embodiments or examples.
尽管已经示出和描述了本发明的实施例， 本领域的普通技术人员可以理解： 在不脱 离本发明的原理和宗旨的情况下可以对这些实施例进行多种变化、 修改、 替换和变型， 本发明的范围由权利要求及其等同物限定。  While the embodiments of the present invention have been shown and described, the embodiments of the invention may The scope of the invention is defined by the claims and their equivalents.

Claims

权利要求书 claims
1、 一种一次性多针管注射针头， 其特征在于， 包括： 1. A disposable multi-tube injection needle, characterized by including:
针座， 所述针座包括柱形筒和顶盖， 所述柱形筒的上端和下端敞开， 所述顶盖设在所 述柱形筒的上端， 所述顶盖上开设有通孔； Needle seat, the needle seat includes a cylindrical barrel and a top cover, the upper and lower ends of the cylindrical barrel are open, the top cover is provided at the upper end of the cylindrical barrel, and a through hole is provided on the top cover;
定位结构， 所述定位结构设在所述顶盖上； Positioning structure, the positioning structure is provided on the top cover;
针管固定件， 所述针管固定件由所述定位结构定位； Needle tube fixing part, the needle tube fixing part is positioned by the positioning structure;
多根针管， 所述针管穿过所述针管固定件且固定在所述针管固定件上， 所述针管的下 端通过所述通孔伸入所述柱形筒内用于剌入注射液存储器取液， 所述针管的上端向上延伸 用于穿剌皮肤并注射， 多根所述针管彼此间隔开分布， 所述针管的上端和下端均具有针尖。 A plurality of needle tubes pass through the needle tube fixing member and are fixed on the needle tube fixing member. The lower end of the needle tube extends into the cylindrical barrel through the through hole for inserting into the injection reservoir and taking out the injection liquid. liquid, the upper end of the needle tube extends upward for puncturing the skin and injecting, a plurality of the needle tubes are spaced apart from each other, and both the upper and lower ends of the needle tube have needle tips.
2、根据权利要求 1所述的一次性多针管注射针头，其特征在于，所述针管固定件包括: 基板部， 所述基板部定位在所述定位结构中， 其中多根所述针管均穿过所述基板部并 固定在所述基板部上。 2. The disposable multi-tube injection needle according to claim 1, characterized in that the needle tube fixing member includes: a base plate portion, the base plate portion is positioned in the positioning structure, wherein a plurality of the needle tubes pass through Pass through the base plate part and be fixed on the base plate part.
3、 根据权利要求 2所述的一次性多针管注射针头， 其特征在于， 所述基板部形成为平 板或曲面板。 3. The disposable multi-tube injection needle according to claim 2, characterized in that the base plate part is formed into a flat plate or a curved plate.
4、 根据权利要求 2或 3所述的一次性多针管注射针头， 其特征在于， 所述针管固定件 还包括： 填充部分， 所述填充部分与所述基板部相连， 所述填充部分位于所述通孔内或穿 过所述通孔， 所述针管穿过所述基板部与填充部分并固定在所述基板部与填充部分上。 4. The disposable multi-tube injection needle according to claim 2 or 3, characterized in that the needle tube fixing member further includes: a filling part, the filling part is connected to the base plate part, the filling part is located at the The needle tube passes through the base plate part and the filling part and is fixed on the base plate part and the filling part.
5、 根据权利要求 4所述的一次性多针管注射针头， 其特征在于， 所述基板部和所述填 充部分采用聚合物一体成型。 5. The disposable multi-tube injection needle according to claim 4, characterized in that the base plate part and the filling part are integrally formed of polymer.
6、 根据权利要求 4所述的一次性多针管注射针头， 其特征在于， 所述基板部和所述填 充部分采用树脂一体成型。 6. The disposable multi-tube injection needle according to claim 4, characterized in that the base plate part and the filling part are integrally molded with resin.
7、 根据权利要求 2-6中任一项所述的一次性多针管注射针头， 其特征在于， 所述定位 结构包括： 7. The disposable multi-tube injection needle according to any one of claims 2-6, characterized in that the positioning structure includes:
定位夹壁， 所述定位夹壁设在所述顶盖的上表面上， 所述针管固定件安装在所述定位 夹壁内。 A positioning clamp wall is provided on the upper surface of the top cover, and the needle tube fixing member is installed in the positioning clamp wall.
8、 根据权利要求 7所述的一次性多针管注射针头， 其特征在于， 所述定位夹壁为环形 夹壁或为沿所述柱形筒的周向彼此间隔开的多个子夹壁部。 8. The disposable multi-tube injection needle according to claim 7, wherein the positioning clamping wall is an annular clamping wall or a plurality of sub-clamping wall portions spaced apart from each other along the circumferential direction of the cylindrical barrel.
9、 根据权利要求 8所述的一次性多针管注射针头， 其特征在于， 所述定位夹壁上设有 用于卡固所述基板部的卡凸。 9. The disposable multi-tube injection needle according to claim 8, characterized in that the positioning clip wall is provided with a latching protrusion for latching the base plate part.
10、 根据权利要求 7所述的一次性多针管注射针头， 其特征在于， 所述针管固定件的 顶部凸出所述定位夹壁并向所述定位夹壁的顶部延伸。 10. The disposable multi-tube injection needle according to claim 7, wherein the top of the needle tube holder protrudes from the positioning clamp wall and extends toward the top of the positioning clamp wall.
11、 根据权利要求 7所述的一次性多针管注射针头， 其特征在于， 所述定位结构还包 括从所述顶盖的下表面向下延伸的凸起部， 所述通孔贯穿所述凸起部， 其中所述针管的下 端穿过所述凸起部伸入所述柱形筒内。 11. The disposable multi-tube injection needle according to claim 7, wherein the positioning structure further includes a protrusion extending downward from the lower surface of the top cover, and the through hole penetrates the protrusion. A raised portion, wherein the lower end of the needle tube extends into the cylindrical barrel through the raised portion.
12、 根据权利要求 11所述的一次性多针管注射针头， 其特征在于， 所述通孔的横截面 沿从上向下或从下向上的方向逐渐增大， 所述针管固定件由填充在所述通孔内以固定所述 针管的结构胶黏剂形成。 12. The disposable multi-tube injection needle according to claim 11, wherein the cross-section of the through hole gradually increases in the direction from top to bottom or from bottom to top, and the needle tube fixing member is filled in The through hole is formed with a structural adhesive that fixes the needle tube.
13、 根据权利要求 7-12中任一项所述的一次性多针管注射针头， 其特征在于， 所述针 管伸出所述定位夹壁的上表面的长度为 0. 2mm-4mm， 所述针管伸入所述柱状筒内的长度为 0. 5mm- 15mm, 所述针管的外径为 60um- 450um， 内径为 30um_250um。 13. The disposable multi-tube injection needle according to any one of claims 7-12, characterized in that the length of the needle tube extending from the upper surface of the positioning clamp wall is 0.2mm-4mm, The length of the needle tube extending into the cylindrical tube is 0.5mm-15mm, the outer diameter of the needle tube is 60um-450um, and the inner diameter is 30um-250um.
14、 根据权利要求 1-13中任一项所述的一次性多针管注射针头， 其特征在于， 所述柱 形筒的外表面设有防滑槽或防滑纹。 14. The disposable multi-tube injection needle according to any one of claims 1 to 13, characterized in that the outer surface of the cylindrical barrel is provided with anti-slip grooves or anti-slip patterns.
15、根据权利要求 1-14所述的一次性多针管注射针头，其特征在于，所述通孔为多个， 多根所述针管分别一一对应地穿过所述通孔。 15. The disposable multi-tube injection needle according to claims 1-14, characterized in that there are a plurality of through holes, and the plurality of needle tubes pass through the through holes in one-to-one correspondence.
16、 根据权利要求 1-15中任一项所述的一次性多针管注射针头， 其特征在于， 至少两 根所述针管的针尖的出液口的法线方向不同。 16. The disposable multi-tube injection needle according to any one of claims 1 to 15, characterized in that the normal directions of the liquid outlets of the needle tips of at least two of the needle tubes are different.
17、 根据权利要求 1-16中任一项所述的一次性多针管注射针头， 其特征在于， 至少两 根所述针管的上端的针尖的形状和 /或水平高度不相等。 17. The disposable multi-tube injection needle according to any one of claims 1 to 16, characterized in that the shapes and/or horizontal heights of the needle tips at the upper ends of at least two of the needle tubes are unequal.
18、 根据权利要求 1-17中任一项所述的一次性多针管注射针头， 其特征在于， 还包括 针管保护套和针座保护套， 所述针管保护套设在所述顶盖上的定位结构外表面上用于保护 所述针管， 所述针座保护套套在所述针座和针管保护套外面， 所述针座保护套的下端敞开 且由密封材料层封闭。 18. The disposable multi-tube injection needle according to any one of claims 1 to 17, characterized in that it also includes a needle tube protective cover and a needle base protective cover, and the needle tube protective cover is provided on the top cover. The outer surface of the positioning structure is used to protect the needle tube. The needle seat protective cover is placed outside the needle seat and the needle tube protective cover. The lower end of the needle seat protective cover is open and closed by a sealing material layer.
19、 一种预灌装注射器， 其特征在于， 包括： 19. A prefilled syringe, characterized in that it includes:
根据权利要求 1-18任一项所述的一次性多针管注射针头； The disposable multi-tube injection needle according to any one of claims 1-18;
注射液存储器， 所述注射液存储器与所述柱状筒的内壁相配合， 所述注射液存储器包 括筒体、 弹性体层和活塞， 所述筒体的顶部和底部均设有开口且所述筒体上设置有容量刻 度， 所述弹性体层固定在所述筒体的顶部用于密封筒体顶部的开口， 所述活塞设置在所述 筒体的底部。 Injection storage, the injection storage matches the inner wall of the cylindrical barrel, the injection storage includes a barrel, an elastomer layer and a piston, the top and bottom of the barrel are both provided with openings and the barrel A capacity scale is provided on the body, the elastomer layer is fixed on the top of the cylinder for sealing the opening at the top of the cylinder, and the piston is provided on the bottom of the cylinder.
20、 根据权利要求 19所述的预灌装注射器， 其特征在于， 所述筒体的下端一体连接有 弯折段， 所述弯折段的自由端与所述柱状筒的外壁螺纹连接或者卡接。 20. The prefilled syringe according to claim 19, wherein the lower end of the barrel is integrally connected with a bending section, and the free end of the bending section is threadedly connected or locked with the outer wall of the cylindrical barrel. catch.
PCT/CN2014/082577 2013-07-19 2014-07-21 Disposable multi-needle injection needle and pre-fillable syringe having same WO2015007243A1 (en)

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