WO2013056588A1 - 一次性阵列式微型注射针头及其预灌装注射器 - Google Patents

一次性阵列式微型注射针头及其预灌装注射器 Download PDF

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Publication number
WO2013056588A1
WO2013056588A1 PCT/CN2012/079773 CN2012079773W WO2013056588A1 WO 2013056588 A1 WO2013056588 A1 WO 2013056588A1 CN 2012079773 W CN2012079773 W CN 2012079773W WO 2013056588 A1 WO2013056588 A1 WO 2013056588A1
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WO
WIPO (PCT)
Prior art keywords
needle
injection
disposable
fixing groove
disposable array
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2012/079773
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English (en)
French (fr)
Chinese (zh)
Inventor
岳瑞峰
王燕
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tsinghua University
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Tsinghua University
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 Tsinghua University filed Critical Tsinghua University
Priority to JP2014536094A priority Critical patent/JP2014533998A/ja
Priority to IN1031KON2014 priority patent/IN2014KN01031A/en
Priority to EP12841214.5A priority patent/EP2749306B1/en
Priority to RU2014119788/14A priority patent/RU2581253C2/ru
Priority to US14/352,987 priority patent/US10058691B2/en
Publication of WO2013056588A1 publication Critical patent/WO2013056588A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/28Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/281Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/283Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by telescoping of ampoules or carpules with the syringe body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023Drug applicators using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/003Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0061Methods for using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3295Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
    • A61M5/3298Needles arranged in parallel
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04CROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
    • F04C2270/00Control; Monitoring or safety arrangements
    • F04C2270/04Force
    • F04C2270/042Force radial
    • F04C2270/0421Controlled or regulated

Definitions

  • the present invention relates to the field of medical cosmetic instruments and medical technology, and more particularly to a disposable array microinjection needle and a prefilled syringe based thereon. Background technique
  • Injection technology and injection devices play an important role in the treatment of diabetes, even as important as the choice of insulin preparations, which is related to the success or failure of glycemic control.
  • Many health care providers and diabetic patients receiving insulin injections often ignore the effects of injection technology itself on glycemic control.
  • Clinicians often consider the reasons for not meeting the expected glycemic control goals from the perspective of insulin preparations, blood glucose self-monitoring, etc., but ignore the impact of injection technology on glycemic control, and the process by which insulin enters the body through the injection device is very important. Link.
  • the body is suitable for injecting insulin not only in the abdomen, but also on the outside of the thigh, 1/4 of the outside of the arm and the buttocks.
  • the rotation of different injection sites refers to the rotation injection between the abdomen, arms, thighs and buttocks.
  • the method of rotating the injection site can effectively improve the curative effect and avoid the possibility of complications.
  • the length of the insulin injection needle is different, and the injection angle and technique are different. For needles of 8 mm and 12.7 mm in length, the skin must be pinched and injected at a 45 ° angle to increase the thickness of the subcutaneous tissue and reduce the risk of injecting insulin into the muscle layer.
  • the pen-type insulin injection has been widely used in diabetic patients because of its advantages such as being easy to learn, accurate in dosage, convenient and durable, slightly painful, and effective.
  • the needles of 8mm X 30G are used for injection in the clinic. According to the instructions, the needle should be left under the skin for at least 6 seconds to 10 seconds after the injection, and continue to hold the push button until The needle is completely pulled out.
  • the liquid medicine is often dripped from the needle eye, so that the accuracy of the therapeutic dose cannot be ensured.
  • the length of the needle of the disposable needle is usually greater than 15 mm, even if the disposable needle on the insulin injection pen has a diameter of 0.25 mm. Kneading can't be directly injected directly into the arm and other parts, and the pain during injection will still make many patients, especially the children, daunting. Since there is only one needle on each needle, the shorter the length of the needle, the lower the length of the needle, the lower the length of the needle. However, after injection and after injection, the needle must be left in the skin, waiting for the liquid to be fully absorbed. The time will inevitably increase significantly. These factors will undoubtedly bring a lot of inconvenience to the patient, which is easy to understand, reduces the patient's compliance with the correct method of injection therapy, and affects the efficacy.
  • the disposable injection needles on the existing insulin injection pens must be used in combination with the insulin injection pens. They are usually stored separately and temporarily assembled together during use. The entire injection device is large in volume and weight and is only suitable for insulin injection. Summary of the invention
  • One technical problem to be solved by the present invention is how to enable a patient to rapidly inject a drug such as insulin into the skin rapidly, without leaking, painlessly, safely and conveniently in the abdomen, arms, thighs, buttocks, etc., and can effectively prevent intramuscular injection. Improve patient compliance and efficacy, reduce pain and complications.
  • Another technical problem to be solved by the present invention is how to enable a wider variety of drugs to be injected using such a needle, and to improve the convenience of the application of the syringe.
  • a disposable array microinjection needle comprising: a lower needle holder, which is a cylindrical barrel having an open end and a top cover at one end for connection with the injection reservoir;
  • the upper needle seat is disposed above the lower needle cover and forms a cavity with the top cover;
  • the top cover is provided with a through hole communicating with the columnar cylinder and the cavity, and the liquid needle is installed in the through hole;
  • One end of the liquid needle communicates with the cavity, and the other end is located in the cylindrical barrel for extracting the injection liquid from the injection reservoir to the cavity;
  • the upper needle seat is mounted with at least two needle tubes, one end of which is a needle tip for puncture and injection of injection, and the other end is mounted on the upper needle holder and communicates with the cavity.
  • the top cover has a positioning clip wall for fixing and sealing the upper and lower needle holders, and the positioning clip wall and the lower needle seat are integrally formed.
  • the upper needle seat is fixed and sealed at the positioning clip wall by a joint action of a structural adhesive or a rubber pad, or both.
  • the bottom cover has a fixing groove, and the fixing groove is coaxially disposed and communicated with the through hole.
  • the inner diameter of the fixing groove is equal to or larger than the inner diameter of the through hole; the liquid taking needle passes through the fixing groove, and It is sealed and fixed in the fixing groove and the through hole by the fixing groove itself structure or structural adhesive.
  • the bottom cover has a fixing groove, and the fixing groove is coaxially disposed and communicated with the through hole.
  • the inner diameter of the fixing groove is smaller than the inner diameter of the through hole or the outer diameter of the liquid taking needle;
  • the fixing groove is fixed in the fixing groove and the through hole by the fixing groove itself.
  • the inner cylinder wall of the cylindrical barrel of the lower needle holder or the outer cylinder wall is provided with a thread and/or a fixed bayonet for detachable connection with the injection reservoir.
  • the outer diameter of the needle tube is 80unT400um, the inner diameter is 30unT200um, and the height from the top of the upper needle holder to the tip of the needle is 0. 2mnT5mm; the outer diameter of the liquid take-up needle is 120unT l000um, the inner diameter is 50unT500um, from the bottom of the fixed groove 2mnTl5 ⁇ The length of the needle tip of the liquid to the needle is 0. 2mnTl5mm.
  • the needle tube and the liquid take-up needle have a needle tip at one or both ends, the needle tip has an elliptical annulus or at least a circular arc surface is cut on the elliptical annulus to have a sharp angle, the elliptical torus and the needle shaft The angle formed is 5 ° ⁇ 88 °.
  • the upper needle seat is a flat substrate or a curved substrate.
  • the needle tube and the liquid take-up needle are made of a metal material
  • the upper needle seat and the lower needle seat are made of one or more polymer materials
  • the polymer comprises plastic, resin and rubber.
  • the upper needle seat and/or the lower needle seat are made of a polymer material, and the direct contact between the needle tube and the upper needle seat and/or between the liquid take-up needle and the lower needle seat forms a tight fit, and no other materials exist. And Fixed sealing structure.
  • the upper needle seat is provided with a positioning groove or an outlet corresponding to the number of needle tubes, and the needle tube is fixed in the corresponding positioning groove or the outlet through the positioning groove or the outlet itself or by using a structural adhesive.
  • the positioning groove or the outlet is integrally formed with the upper needle seat or is produced separately.
  • the sidewall of the upper needle seat is provided with at least one opening or groove, and the opening or the four slots are filled with a structural adhesive, and the structural adhesive is wrapped around the outside of the needle tube and fixed to the positioning of the upper needle seat. Inside the tank or outlet.
  • the upper needle housing is provided with a needle protection sleeve; the upper and lower needle housings are provided with a needle seat protection sleeve; the lower portion of the needle holder protection sleeve has a sealing material layer, and the sealing material layer is preferably It is a sealed dialysis paper.
  • the present invention provides a disposable prefilled syringe using the disposable array microinjection needle described above, characterized in that:
  • the disposable prefilled syringe is composed of the disposable array microinjection needle and an injectable reservoir, which is a sealed container internally filled with a medical liquid, all or part of which is disposed in the lower needle
  • the container has a top end which can be pierced by the liquid take-up needle, and has a movable part or a piston at the bottom end thereof, and the liquid take-up needle can be pierced into the above by manually rotating and/or pressing the container during use.
  • the top of the container and the bottom of the container push the movable part or the piston to squeeze the liquid through the liquid take-up needle for injection.
  • the disposable array micro injection needle and the injection liquid reservoir are assembled into one body, and are sterilized and enclosed in the needle seat protective sleeve, or the disposable array micro injection needle and the injection liquid storage are separately stored, Reassemble into one when in use.
  • the disposable array micro-injection needle provided by the above technical solution can be directly used on the existing insulin injection pen, and a plurality of slender, short and strong needles arranged at a certain interval are simultaneously injected, without pinching.
  • the abdomen, arms, thighs, buttocks, etc. are fast, liquid-free, painless, safe, and convenient to inject insulin and other drugs vertically under the skin, and completely avoid the hidden dangers that may be directly injected into the muscles, thus providing the majority of patients from the source.
  • An injection tool that can easily rotate the injection site, avoid intramuscular injection, and can perform painless and rapid injection, significantly improves the patient's compliance and treatment effects, and has a profound impact on blood glucose control and rehabilitation of diabetic patients.
  • the disposable prefilled syringe provided by the above technical solution can be large
  • the wide-spread disposable micro-injection needle has a suitable range for the type of injectable medicine, and has a compact structure and is convenient to use.
  • FIG. 1 is a cross-sectional view showing the structure of a disposable array type microinjection needle in which the upper needle holder is a flat substrate according to Embodiment 1 of the present invention
  • FIG. 2 is a cross-sectional view showing a tip structure of a miniature metal needle tube according to Embodiment 1 of the present invention
  • FIG. 3 is a cross-sectional view showing a tip structure of another miniature metal needle tube according to Embodiment 1 of the present invention
  • Figure 5 is a cross-sectional view showing the structure of a disposable array type microinjection needle having an integrated outlet array and a side wall having a groove in the upper needle holder according to Embodiment 2 of the present invention
  • FIG. 6 is a cross-sectional view showing the structure of a disposable array microinjection needle having an integrated outlet array and an opening in the side wall of the upper needle holder according to Embodiment 2 of the present invention
  • FIG. 7 is a cross-sectional view showing the structure of a disposable array microinjection needle having an integrated outlet array and an opening in the side wall of the upper needle holder according to Embodiment 2 of the present invention
  • Figure 8 is a cross-sectional view showing the structure of a disposable array microinjection needle having a split outlet array in the upper needle holder and an opening in the side wall in the second embodiment of the present invention
  • Fig. 9 is a structural schematic view showing a disposable array type microinjection needle having a bayonet on a lower needle holder according to a second embodiment of the present invention.
  • Figure 10 is a cross-sectional view showing the structure of a disposable array type microinjection needle which is fixedly sealed by a structural adhesive in Embodiment 1 of the present invention.
  • Figure 11 is a cross-sectional view showing the structure of a disposable array type microinjection needle which can be fixedly sealed between the needle tube and the upper needle holder and between the liquid take-up needle and the lower needle seat in the first embodiment of the present invention.
  • Figure 12 is a cross-sectional view showing the structure of a disposable array type microinjection needle in which only the upper and lower needle holders are fixedly sealed by a structural adhesive in the first embodiment of the present invention.
  • FIG. 13 is a schematic structural view of a disposable array microinjection needle in which the upper needle holder is a square planar substrate according to Embodiment 1 of the present invention.
  • Figure 14 is a cross-sectional view showing the structure of a disposable prefilled syringe in Embodiment 3 of the present invention.
  • 1 needle tube
  • 2 upper needle seat
  • 3 lower needle seat
  • 4 liquid needle
  • 5 needle tip
  • 5a elliptical torus
  • 5b sharp corner
  • 6 structural adhesive
  • 7 positioning wall
  • 8 thread
  • 8-1 solid
  • FIG. 1 is a cross-sectional view showing the structure of a disposable array type microinjection needle according to an embodiment of the present invention, which includes a lower needle holder 3 having an open end and a cylindrical tube structure having a cap at one end, and the lower needle holder 3 is used for storage with an injection solution.
  • the upper needle holder 2 is disposed above the top cover of the lower needle holder 3, and a cavity 15 is formed between the upper needle holder 2 and the top cover.
  • a through hole communicating with the columnar cylinder and the cavity 15 is opened in the top cover, and a liquid take-up needle 4 is mounted in the through hole, and the liquid take-up needle 4 is selected from a metal needle, one end of which is connected to the cavity 15 and the other end is located in the columnar shape.
  • the liquid take-up needle 4 is selected from a metal needle, one end of which is connected to the cavity 15 and the other end is located in the columnar shape.
  • the needle tube 1 is selected from short and thin micro metal needle tubes, and the needle tubes 1 are arranged on the upper needle holder 2 according to a regular rule to form an array of needle tubes.
  • One end of the needle tube 1 is a needle tip for puncture and injection, and the other end is mounted on the upper needle holder 2 and communicates with the above-mentioned cavity 15.
  • the microinjection needle thus formed is extracted from the injectable reservoir by the liquid take-up needle 4 after being connected to the injectable reservoir, and is sent to the cavity 15 between the upper needle hub 2 and the lower needle hub 3
  • the cavity 15 is used for the outlet joint of the injection fluid to be switched, and then the injection is injected by the needle tube array formed by the needle tube 1.
  • a positioning clip wall 7 for fixing and sealing the upper and lower needle holders is disposed above the top cover of the lower needle holder 3, and the positioning clip wall and the lower needle holder are integrally formed by positioning the clamping wall 7 and the upper needle holder 2
  • the close contact between the upper and lower needle holders is sealed as shown in Figures 1 and 11; as a preferred solution, the upper needle holder 2 can be fixed and sealed by a combination of structural adhesive or rubber pad or both.
  • the cross-sectional shape and size in the positioning wall 7 correspond to the shape and size of the upper needle holder 2 to ensure the tightness of the cavity 15 below the upper needle holder 2, as shown in FIG.
  • a fixing groove 16 is disposed under the top cover of the lower needle holder 3, and the fixing groove 16 is coaxially disposed and communicated with the through hole on the lower needle holder 3, and the inner diameter of the fixing groove 16 is equal to or larger than the inner diameter of the through hole or the liquid take-up needle Outside of 4
  • the liquid take-up needle 4 passes through the fixing groove and is sealed and fixed in the fixing groove and the through hole by the fixing groove itself structure or structural adhesive 6.
  • the inner diameter of the fixing groove 16 is smaller than the inner diameter of the through hole or the outer diameter of the liquid take-up needle 4, and the liquid take-up needle 4 passes through the fixing groove, and the fixing groove is deformed at this time, thereby being fixedly fixed to the fixing groove and the through-sealing structure by the fixing groove itself. Inside the hole.
  • a thread 8 is also provided on the inner or outer cylinder wall of the cylindrical barrel of the lower needle holder 3 for detachable connection with the injection reservoir for facilitating replacement of the disposable injection needle.
  • the thread 8 in this embodiment can also be replaced with a fixed bayonet, correspondingly disposed on the outer wall of the injecting fluid reservoir, and the fixing bayonet can be fixed on the protrusion by rotation to realize the disposable needle. Connection to the injectable reservoir; Disassembly can be achieved by reverse rotation when the needle is removed.
  • both the threaded and fixed bayonet are present on the cylindrical wall of the lower needle holder 3 for better use with certain syringe reservoirs.
  • the upper needle hub 2 is provided with a needle guard 9.
  • the upper and lower needle hubs are provided with a needle guard 10, and the lower portion of the needle guard 10 has a sealed dialysis paper 11 at the opening.
  • the above structure is provided to ensure that the injection needle is sterile and clean, and is not easily damaged.
  • the sealed dialysis paper 11, the needle guard 10 and the needle guard 9 can be removed in sequence.
  • the upper needle holder 2 is a flat substrate as shown in Figs. 1, 11, and 12.
  • the needle tube 1 and the liquid take-up needle 4 are made of a metal material such as stainless steel, and the upper needle holder 2 and the lower needle holder 3 are made of one or more polymer materials, and the polymer includes plastic, resin, and rubber.
  • the upper needle holder 2 and the lower needle holder 3 can be prepared from the same or different polymer materials.
  • a medical polymer material such as epoxy resin or polypropylene or a resin/plastic composite material such as epoxy resin/polypropylene can be used.
  • the lower needle seat 3 can be made of polypropylene, polyvinyl chloride, polyethylene, etc., and the structural adhesive 6 can be selected from medical adhesive materials such as epoxy resin, and can be prepared by using mature processing techniques.
  • the upper or lower needle seat is made of a polymer material, and the direct contact between the needle tube and the upper needle seat and/or between the liquid take-up needle and the lower needle seat forms a tight fit, and no other material exists. And its fixed sealing structure, as shown in Figure 11.
  • FIG. 2 is a cross-sectional view showing the structure of a needle tip of a micro metal needle tube and a liquid take-up needle according to the embodiment, wherein the end of the needle tip 5 of the needle tube 1 and the liquid take-up needle 4 is an elliptical annular surface 5a, and the elliptical annular surface 5a and the needle tube 1 are axially
  • the angle of formation is from 5 ° to 88 °.
  • the needle tube 1 and the liquid take-up needle 4 have a needle tip at one or both ends, and the needle tips at both ends are more suitable for the case where the inner diameter of the fixing groove 16 is smaller than or equal to the inner diameter of the through hole or the outer diameter of the liquid take-up needle 4, so that the needle is easier to insert. Fixing the slot, and even if the tip passes through the cavity 15 against the bottom of the upper seat 2, it is still ensured that the injection liquid is delivered from the reservoir into the cavity 15, as shown in Fig. 12, and the outer diameter of the micro metal needle 1 is 80unT400um, and the inner diameter is 30unT200um, from the upper needle seat. 2 The height from the top to the tip 5 is 0.
  • the needle 1 of this size is slender, short and strong, and the injection can be injected vertically under the skin in the abdomen, arms, thighs, buttocks, etc. without pinching, and Completely avoid the hidden dangers that may be directly injected into the muscles.
  • 2mm ⁇ 15 ⁇ The outer diameter of the tip of the needle is 0. 2mm ⁇ 15mm.
  • Fig. 4 is a cross-sectional view showing the structure of an injection needle having an integral outlet array in the upper needle holder of the embodiment. It is similar to the structure of the injection needle in the first embodiment, and the main difference is that: the upper needle holder 2 is a curved substrate, and has an array of positioning grooves or an outlet array integrally formed with the same, that is, the upper needle
  • the seat 2 is provided with at least two positioning grooves or outlets 12. The number and arrangement positions of the positioning grooves or the outlets 12 are set according to the number of the needle tubes 1 and the array distribution to be formed, and the needle tube 1 is fixed to the positioning by the structural adhesive 6. In the slot or outlet 12.
  • Fig. 5 is a cross-sectional view showing the structure of an injection needle having an integral outlet array in the upper needle holder and having a groove formed in the side wall in the embodiment. It is similar to the structure of the injection needle in FIG. 4, and the main difference is that: the upper needle seat 2 has a groove 13 on one side wall, and the groove 13 is filled with a structural adhesive, and the structural adhesive is wrapped in the micro metal needle 1 The outside is fixed and fixed in the positioning groove or outlet 12 in the upper needle holder 2.
  • Fig. 6 is a cross-sectional view showing the structure of an injection needle having an integral outlet array and an opening in the side wall of the upper needle holder in the embodiment, which is similar to the structure of the injection needle of Fig. 5, and the main difference is that the upper needle
  • the side wall of the middle portion of the seat 2 has an opening 14 at which the structural adhesive is filled, and the structural adhesive is wrapped around the micro metal needle 1 and fixed in the positioning groove or outlet 12 in the upper needle holder 2.
  • Fig. 7 is a cross-sectional view showing the structure of an injection needle having an integral outlet array and an opening in the side wall of the upper needle holder in the embodiment, which is similar to the structure of the injection needle of Fig. 6, and the main difference is that : There is no protruding bayonet at the port of the lower needle retaining clip wall, and it is necessary to completely rely on the structural adhesive to fix and seal the upper needle seat.
  • Fig. 8 is a cross-sectional view showing the structure of the injection needle having the split outlet array in the upper needle holder and the opening in the side wall in the embodiment, which is similar to the structure of the injection needle in Fig. 6, and the main difference is as follows:
  • the seat 2 is formed separately from the positioning groove or the outlet 12, and the opening 14 is filled with a structural adhesive. 6.
  • the structural adhesive 6 is wrapped around the micro metal needle tube 1 and fixed in the positioning groove or the outlet 12 in the upper needle holder 2, and the upper needle holder 2 is bonded and fixed to the positioning groove or the outlet 12 as One.
  • the upper needle holder 2 and the lower needle holder 3 can be made of polypropylene, polyvinyl chloride, polyethylene, etc.
  • the structural adhesive can be selected from medical structural adhesives such as epoxy resin, and can adopt mature processing technology. Preparation was carried out.
  • FIG. 9 is a schematic view showing the structure of an injection needle having a bayonet on the lower needle holder in the embodiment, which is similar to the syringe structure shown in any of FIGS. 1 and 4 to 8.
  • the main difference is as follows: the lower needle holder 3 is provided on the side wall of the cylindrical cylinder as the fixing bayonet 8-1 as described in Embodiment 1.
  • the selection of the specific fixing bayonet or screw depends on the interface structure of the injection reservoir, and other matching interfaces can also be selected. structure.
  • Figure 14 is a cross-sectional view showing the structure of a disposable prefilled syringe using the above disposable array microinjection needle according to an embodiment of the present invention, which is stored by a disposable array microinjection needle and an injectable solution which can have a capacity scale.
  • the injector reservoir is connected to the disposable array microinjection needle by threads and/or a fixed bayonet, both of which are movable relative to each other.
  • the injection reservoir is a sealed container 17 internally filled with a chemical solution 18, all or part of which is disposed in a cylindrical barrel of the lower needle holder 3, and the container 17 has a tip end 19 which is easily pierced by the liquid take-up needle, and has a bottom end having a bottom end
  • the moving part or piston 20, the moving part or piston 20 seals the injection fluid within the container 17.
  • the container 17 can be moved toward the disposable array microinjection needle by manually rotating and/or pressing the container 17, thereby piercing the liquid take-up needle 4 into the top end of the container 17 and pushing the movable part at the bottom end of the container 17 or
  • the piston 20 squeezes the drug solution through the liquid take-up needle for injection.
  • the disposable array micro-injection needle and the injection reservoir are assembled into one body and sterilized and enclosed in the needle seat protective sleeve, or the disposable array micro-injection needle and the injection liquid storage are separately stored, and assembled into one during use. .

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  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
PCT/CN2012/079773 2011-10-18 2012-08-07 一次性阵列式微型注射针头及其预灌装注射器 Ceased WO2013056588A1 (zh)

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JP2014536094A JP2014533998A (ja) 2011-10-18 2012-08-07 使い捨てアレイ型マイクロ注射針ヘッド及びそのプレフィルド注射器
IN1031KON2014 IN2014KN01031A (enExample) 2011-10-18 2012-08-07
EP12841214.5A EP2749306B1 (en) 2011-10-18 2012-08-07 Disposable array-type micro injection needle head and pre-filling injector thereof
RU2014119788/14A RU2581253C2 (ru) 2011-10-18 2012-08-07 Одноразовая многоигольная головка для микроинъекций и предварительно наполненный шприц
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015033349A1 (en) * 2013-09-09 2015-03-12 Nanopass Technologies Ltd. Prefilled syringe devices employing microneedle interfaces for intradermal delivery
WO2015098645A1 (ja) * 2013-12-24 2015-07-02 公立大学法人横浜市立大学 注射針
JP2017514576A (ja) * 2014-04-30 2017-06-08 キンバリー クラーク ワールドワイド インコーポレイテッド 経皮的薬物送達装置のレセプタクル部分および方法

Families Citing this family (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK2384210T3 (da) 2008-12-02 2017-11-27 Allergan Inc Injektionsanordning
CN102327656B (zh) * 2011-10-18 2013-05-08 清华大学 一次性阵列式微型注射针头
CN103127586B (zh) * 2011-11-25 2015-12-02 清华大学 金属针管阵列元件及由其形成的一次性阵列式注射针头
JP6037722B2 (ja) * 2012-08-27 2016-12-07 南部化成株式会社 注射針
EP2716324A1 (en) * 2012-10-04 2014-04-09 Sanofi-Aventis Deutschland GmbH Microneedle arrangement and adapter
US20140350518A1 (en) 2013-05-23 2014-11-27 Allergan, Inc. Syringe extrusion accessory
CN103341228B (zh) * 2013-07-19 2015-08-12 清华大学 一种预灌装注射器
US10029048B2 (en) 2014-05-13 2018-07-24 Allergan, Inc. High force injection devices
CN104043192B (zh) * 2014-06-28 2016-08-24 陈彦彪 一次性微针装置
US10226585B2 (en) 2014-10-01 2019-03-12 Allergan, Inc. Devices for injection and dosing
CN204219537U (zh) * 2014-11-04 2015-03-25 温州市贝普科技有限公司 一次性使用安全自毁胰岛素针
WO2016072060A1 (ja) * 2014-11-05 2016-05-12 凸版印刷株式会社 マイクロニードルセット
WO2016101069A1 (en) * 2014-12-23 2016-06-30 Atkinson Cole Michael Joseph Multiple needle assembly
CA2976544A1 (en) 2015-03-10 2016-09-15 Allergan Pharmaceuticals Holdings (Ireland) Unlimited Company Multiple needle injector
JP6986969B2 (ja) * 2015-04-07 2021-12-22 エルテーエス ローマン テラピー−ジステーメ アーゲー 液体製剤を投与するためのマイクロニードルシステム
EP3367946B1 (en) 2015-10-27 2020-07-08 Nanopass Technologies Ltd. Microneedle device with mechanical guide
US10287543B2 (en) 2015-11-19 2019-05-14 Miltenyi Biotec, Gmbh Process and device for isolating cells from biological tissue
KR102288170B1 (ko) 2016-04-08 2021-08-09 알레간 인코포레이티드 흡인 및 주입 디바이스
JP3207783U (ja) * 2016-09-20 2016-12-01 南部化成株式会社 注射針
EP3318300A1 (en) 2016-11-02 2018-05-09 Miltenyi Biotec GmbH Perfusion device for biological tissue
USD867582S1 (en) 2017-03-24 2019-11-19 Allergan, Inc. Syringe device
JP7037026B2 (ja) * 2017-10-06 2022-03-16 シンクランド株式会社 麻酔シリンジ本体用のキャップ及びアプリケータ
CN107961417A (zh) * 2017-12-28 2018-04-27 无锡顶点医疗器械有限公司 一种胰岛素泵用输注管路结构
WO2019148174A2 (en) * 2018-01-29 2019-08-01 Illume Health LLC Method and system for personalized injection and infusion site optimization
TWI734958B (zh) 2018-03-19 2021-08-01 日商泰爾茂股份有限公司 穿刺針及導管組合體
CN110038193A (zh) * 2019-04-03 2019-07-23 江苏吉春医用器材有限公司 一种带保护套的针头
CN110237358A (zh) * 2019-06-27 2019-09-17 张艳琳 一种高精度胰岛素注射器及其应用
CN110339475B (zh) * 2019-07-31 2024-02-09 清华大学 多针管阵列及具有其的注射针头和注射器
CA3161261A1 (en) * 2019-12-12 2021-06-17 David POGANSKI Pen needle apparatus
CN111588982A (zh) * 2020-05-07 2020-08-28 昆山安卓医疗科技有限公司 一种十六孔水光针
RU2767233C1 (ru) * 2021-05-27 2022-03-17 Инна Игоревна Иванова Игла для шитья вручную
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CN113975546B (zh) * 2021-11-25 2023-12-26 北京快舒尔医疗技术有限公司 注射器主体和注射器
KR102428027B1 (ko) * 2022-02-07 2022-08-01 한상범 마이크로 니들이 장착된 스탬프형 유체 주입용기
CN115463287B (zh) * 2022-09-29 2024-12-06 珠海丽笙医疗科技有限公司 注射针组件及装针方法
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WO2025257272A1 (en) * 2024-06-14 2025-12-18 U-Needle Holding B.V. Microneedle assembly and injection kit

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100998901A (zh) * 2007-01-12 2007-07-18 中国科学院上海微系统与信息技术研究所 多孔硅无痛注射微针阵列及其制备方法
EP1852142A1 (en) * 2006-05-03 2007-11-07 IGEA S.r.l. Fluid dispensing system
US20110092883A1 (en) * 2009-10-16 2011-04-21 Kenichi Uchiyama Transdermal drug administration apparatus and transdermal drug administration unit
CN102327656A (zh) * 2011-10-18 2012-01-25 清华大学 一次性阵列式微型注射针头
CN202342607U (zh) * 2011-10-18 2012-07-25 清华大学 一次性阵列式微型注射针头

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6146361A (en) * 1996-09-26 2000-11-14 Becton Dickinson And Company Medication delivery pen having a 31 gauge needle
JP3035292B1 (ja) * 1999-03-24 2000-04-24 日本イーライリリー株式会社 針ユニット収納ケ―ス
DE19955652A1 (de) * 1999-11-19 2001-06-13 Schott Glas Verschluß für eine vorfüllbare Einmalspritze
CN100349629C (zh) * 2001-09-12 2007-11-21 贝克顿迪肯森公司 用于药物传送的微针为基础的笔装置和使用该装置的方法
JP2003205035A (ja) * 2001-11-12 2003-07-22 Jms Co Ltd 注射針引込み型注射器
US8932264B2 (en) * 2003-08-11 2015-01-13 Becton, Dickinson And Company Medication delivery pen assembly with needle locking safety shield
AU2005291585B2 (en) * 2004-10-04 2011-04-07 Sanofi-Aventis Deutschland Gmbh Drive mechanism for a drug delivery device
US7645264B2 (en) * 2005-04-11 2010-01-12 Becton, Dickinson And Company Injection device with secondary reservoir
US20080125745A1 (en) * 2005-04-19 2008-05-29 Shubhayu Basu Methods and compositions for treating post-cardial infarction damage
JP2010512170A (ja) * 2005-12-08 2010-04-22 ナノパス テクノロジーズ エルティディ. 薬剤投与器用マイクロ・ニードル・アダプタ
US7780637B2 (en) * 2006-11-06 2010-08-24 Steven Jerde Medical device container
JP2008154849A (ja) * 2006-12-25 2008-07-10 Ritsumeikan 注入装置
CA2639320C (en) * 2007-09-07 2016-10-25 Becton, Dickinson And Company Pen-needle assembly for preventing under-torquing and over-torquing of pen-needle
CN201161026Y (zh) * 2007-11-18 2008-12-10 刘泽木 一种带有分体式内针座的不可取下针头的胰岛素注射器
CN101829396B (zh) * 2009-03-27 2013-01-30 清华大学 微针阵列芯片及利用其的经皮给药贴剂及其制备方法
JP2011011000A (ja) * 2009-07-06 2011-01-20 Terumo Corp 針管、医療器具および医療器具の製造方法
JP5702384B2 (ja) * 2009-07-31 2015-04-15 スリーエム イノベイティブ プロパティズ カンパニー 中空マイクロニードルアレイ

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1852142A1 (en) * 2006-05-03 2007-11-07 IGEA S.r.l. Fluid dispensing system
CN100998901A (zh) * 2007-01-12 2007-07-18 中国科学院上海微系统与信息技术研究所 多孔硅无痛注射微针阵列及其制备方法
US20110092883A1 (en) * 2009-10-16 2011-04-21 Kenichi Uchiyama Transdermal drug administration apparatus and transdermal drug administration unit
CN102327656A (zh) * 2011-10-18 2012-01-25 清华大学 一次性阵列式微型注射针头
CN202342607U (zh) * 2011-10-18 2012-07-25 清华大学 一次性阵列式微型注射针头

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015033349A1 (en) * 2013-09-09 2015-03-12 Nanopass Technologies Ltd. Prefilled syringe devices employing microneedle interfaces for intradermal delivery
WO2015098645A1 (ja) * 2013-12-24 2015-07-02 公立大学法人横浜市立大学 注射針
JP2017514576A (ja) * 2014-04-30 2017-06-08 キンバリー クラーク ワールドワイド インコーポレイテッド 経皮的薬物送達装置のレセプタクル部分および方法

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US10058691B2 (en) 2018-08-28
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EP2749306A1 (en) 2014-07-02
IN2014KN01031A (enExample) 2015-10-09
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US20140257190A1 (en) 2014-09-11

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