WO2022077910A1 - 一种自动注射器 - Google Patents

一种自动注射器 Download PDF

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Publication number
WO2022077910A1
WO2022077910A1 PCT/CN2021/095525 CN2021095525W WO2022077910A1 WO 2022077910 A1 WO2022077910 A1 WO 2022077910A1 CN 2021095525 W CN2021095525 W CN 2021095525W WO 2022077910 A1 WO2022077910 A1 WO 2022077910A1
Authority
WO
WIPO (PCT)
Prior art keywords
housing
needle
push rod
rear end
inner tube
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/CN2021/095525
Other languages
English (en)
French (fr)
Inventor
倪世利
孙小峰
徐千贺
李文政
李志飞
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.)
Shandong Weigao Prefills Pharmaceutical Packaging Co Ltd
Original Assignee
Shandong Weigao Prefills Pharmaceutical Packaging Co Ltd
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=81208870&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2022077910(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from CN202011110579.9A external-priority patent/CN112076364B/zh
Priority claimed from CN202022322096.7U external-priority patent/CN212914096U/zh
Priority to EP25156845.7A priority Critical patent/EP4529937A3/en
Priority to ES21878964T priority patent/ES3017862T3/es
Priority to EP25156849.9A priority patent/EP4527431A3/en
Priority to EP25156842.4A priority patent/EP4527430A3/en
Application filed by Shandong Weigao Prefills Pharmaceutical Packaging Co Ltd filed Critical Shandong Weigao Prefills Pharmaceutical Packaging Co Ltd
Priority to EP21878964.2A priority patent/EP4230241B1/en
Priority to US18/032,160 priority patent/US20230390502A1/en
Publication of WO2022077910A1 publication Critical patent/WO2022077910A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2418—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for damping shocks on ampoule
    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2433—Ampoule fixed to ampoule holder
    • A61M2005/2437—Ampoule fixed to ampoule holder by clamping means
    • 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • 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
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A61M5/3204—Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices

Definitions

  • the invention relates to the technical field of medical instruments, in particular to an automatic injector.
  • An auto-injector is a medical device that can automatically inject a liquid drug in a prefilled syringe into a patient's body, which can meet the needs of users for self-administration.
  • Auto-injector is a kind of medical device used by patients. Since the general patient is not a professional medical staff, the auto-injector is usually required to be easy to use, high reliability, comfortable experience, etc., and can send a prompt signal after the injection is completed. to help prompt the user to confirm that the injection is complete.
  • the puncture and injection are generally achieved by simply pressing the front end of the syringe against the site to be injected and requiring the rear end of the syringe to be moved by hand.
  • the activation part on the auto-injector is pressed to activate the auto-injector, the needle can quickly pierce the skin, and the drug is automatically injected through the needle.
  • the existing auto-injector has a complex structure and a large number of internal parts, which is easy to cause product function failure, resulting in poor product reliability, and many product processing and assembly procedures, resulting in high product cost.
  • the purpose of the present invention is to provide an automatic injector with simple structure, high reliability, easy product assembly and low cost.
  • the present invention provides the following technical solutions:
  • An automatic injector comprising: a casing, a needle guard, a push rod, a sounding cylinder, an inner tube, a release ring, a driving elastic member, and a reset elastic member;
  • the casing is provided with a needle cylinder fixing structure for fixing the needle cylinder, and the front end of the casing is provided with an opening for the needle to extend;
  • the inner side of the housing is provided with the release ring and the needle guard slidably in sequence from the rear end to the front end, and the needle guard can protrude from the front end of the housing and can be backward relative to the housing
  • the end slides and pushes the release ring, the reset elastic piece acts on the release ring and drives the release ring to push the needle guard to slide toward the front end of the housing;
  • a needle guard limiting structure for the forward sliding distance of the needle guard relative to the housing;
  • the push rod is slidably arranged inside the housing along the axial direction, and the front end of the push rod is used to push the piston in the needle cylinder, and the driving elastic member acts on the push rod and drives the push rod.
  • the rod slides toward the front end of the needle cylinder, and the outer periphery of the push rod is provided with a push rod limit structure;
  • the ratchet is axially slidably sleeved on the outer circumference of the push rod, and the driving elastic piece acts on the rattle and drives the rattle to slide toward the rear end of the housing.
  • a push rod limit matching structure and a sound barrel limit structure is arranged between the sound barrel and the inner tube;
  • the inner tube is fixed inside the casing and is sleeved on the outer circumference of the sound barrel, the release ring is slidably sleeved on the outer circumference of the inner tube, and the inner tube is provided with a radially elastically movable a first clip, which is displaced radially outward under the action of its own elastic force;
  • the first clip can be displaced radially inwardly under the limiting action of the inner wall of the release ring, and is mutually clamped and limited by the push rod limit matching structure and the push rod limit structure,
  • the clapboard limiting structure can limit the relative sliding of the clapboard and the inner tube under the support of the outer wall of the push rod, and the push rod can be disengaged from the push rod after sliding a preset distance to the front end.
  • the support of the limit structure of the rattle can be displaced radially inwardly under the limiting action of the inner wall of the release ring, and is mutually clamped and limited by the push rod limit matching structure and the push rod limit structure,
  • the clapboard limiting structure can limit the relative sliding of the clapboard and the inner tube under the support of the outer wall of the push rod, and the push rod can be disengaged from the push rod after sliding a preset distance to the front end.
  • the support of the limit structure of the rattle can be displaced radially inward
  • the rear end of the casing is provided with a signal structure for impacting and limiting the position of the sound barrel.
  • the signal structure is an end plate fixed to the rear end of the housing.
  • a needle cap is also included, and the needle cap is detachably connected to the front end of the needle guard.
  • the rear end of the needle cap is provided with a hook claw for mutually engaging with the rear end of the needle sheath, and the hook claw can exert a pulling force in the direction of the front end of the needle sheath.
  • an anti-separation concave-convex matching structure is provided between the inner ring of the needle cap and the circumferential direction of the needle guard.
  • a needle cap limiting structure for restricting the movement of the needle cap in the rearward direction relative to the housing is provided between the housing and the needle cap.
  • the needle cylinder fixing structure is a needle cylinder fixing cylinder fixed on the inner side of the housing, and the front end of the needle cylinder fixing cylinder is provided with a needle cylinder clip for limit matching with the front end shoulder of the needle cylinder claw.
  • the rear end of the syringe fixing barrel is provided with a support body for cooperating with the rear end flange of the syringe barrel, and the support body is connected to the front end surface of the rear end flange of the syringe barrel.
  • the front end of the inner tube abuts against the rear end surface of the rear end flange of the syringe, and the rear end of the inner tube abuts against the rear end of the housing.
  • the rear end of the housing is provided with an annular protrusion coaxially cooperating with the rear end of the inner tube, and a side wall of the housing and the inner tube is provided with an annular protrusion for preventing the inner tube Rotation limit structure for tube rotation.
  • the push rod limit matching structure is a squeak avoidance notch formed on the side wall of the squeak, and the squeak avoidance notch is arranged along the axial direction of the squeak.
  • the rattle tube limiting structure includes a rattle tube protrusion disposed on the outer wall of the rattle tube, and an inner tube clamping hole opened on the inner tube and used for limit clamping with the rattle tube protrusion .
  • the inner tube is provided with an inner tube avoidance slot extending in the axial direction
  • the release ring is provided with a second clip that is slidably matched with the inner tube avoidance slot, and the second clip can Interacting with the ratchet
  • the outer side of the rattle is provided with a clip limiting structure for restricting the movement of the second clip toward the rear end of the housing.
  • the push rod is a hollow rod-shaped structure
  • the driving elastic member is a push rod spring arranged inside the push rod, and the push rod spring is compressed and arranged at the front end of the push rod and the ring. between the rear ends of the barrel.
  • a spring guide rod is slidably arranged inside the push rod, and the push rod spring is sleeved on the outer circumference of the spring guide rod.
  • the return elastic member is a return spring, and the return spring is compressed and arranged between the release ring and the housing.
  • the casing includes a front casing and a rear casing, and the front casing is connected to the front end of the rear casing.
  • both the housing and the needle guard are provided with observation windows extending in the axial direction.
  • the needle guard limiting structure includes a first limiting step provided on the inner wall of the housing and a second limiting step provided on the outer wall of the needle guard.
  • the inside of the housing of the automatic injector can be pre-installed and fixed with a pre-filled syringe, the needle is arranged toward the front end opening of the housing, and the needle can be protected by a needle sheath.
  • the needle shield protrudes from the housing. The front end of the body and can protect the needle and needle sheath.
  • the first clip of the inner tube is released from the limit of the inner wall of the release ring, thereby releasing the clip limit of the push rod, and the push rod moves downward under the action of the driving elastic member
  • the front end of the syringe slides, and the liquid in the syringe is injected into the body through the needle through the piston, thereby realizing automatic injection.
  • the outer wall of the push rod can provide continuous support to the squeezing cylinder limiting structure, thereby ensuring that the positions of the squeezing cylinder and the inner tube are relatively fixed; and when the push rod slides a preset distance, that is, the push rod After the pre-set amount of liquid in the syringe is injected, the ringing cylinder limiting structure is separated from the support of the outer wall of the push rod, so that the ringing cylinder can slide to the rear end of the housing under the action of the driving elastic member.
  • the sounding cylinder can prompt the user to complete the injection by sounding, illuminating, impacting and vibrating. The user simply pulls the needle out of the body to complete the entire injection process.
  • the automatic injector provided by this scheme can realize the automatic injection function of the prefilled syringe through eight parts. Compared with the automatic injector in the prior art, this scheme has a simple structure and a small number of parts;
  • FIG. 1 is a schematic diagram of the overall external structure of an automatic injector in a specific embodiment of the present invention
  • Fig. 2 is the first internal structure schematic diagram of the automatic injector in the specific embodiment of the present invention.
  • Fig. 3 is the second internal structure schematic diagram of the automatic injector in the specific embodiment of the present invention.
  • FIG. 4 is a schematic diagram of the positional relationship between the needle cap, the needle cylinder and the needle sheath in a specific embodiment of the present invention
  • FIG. 5 is a schematic structural diagram of a needle cap in a specific embodiment of the present invention.
  • FIG. 6 is a schematic diagram of the position-limiting assembly of the needle cap and the front housing in a specific embodiment of the present invention.
  • FIG. 7 is a schematic diagram of the axial limit of the needle guard and the front housing in a specific embodiment of the present invention.
  • FIG. 8 is a schematic diagram of the axial limit of the needle guard and the needle cap in the specific embodiment of the present invention.
  • FIG. 9 is a schematic diagram of the positioning of the front housing and the shoulder of the syringe in a specific embodiment of the present invention.
  • FIG. 10 is a schematic diagram of the positional relationship between the cushion block and the rear end flange in a specific embodiment of the present invention.
  • FIG. 11 is a schematic diagram of the positional relationship between the cushion block and the front housing in a specific embodiment of the present invention.
  • FIG. 12 is a schematic diagram of the external structure of a push rod in a specific embodiment of the present invention.
  • FIG. 13 is a schematic diagram of a hollow structure of a push rod in a specific embodiment of the present invention.
  • FIG. 14 is a schematic diagram of the assembly structure of a push rod and a push rod spring in a specific embodiment of the present invention.
  • 15 is a schematic diagram of the external structure of the rattle in a specific embodiment of the present invention.
  • 16 is a schematic diagram of the internal structure of the assembly of the rattle cylinder and the push rod in a specific embodiment of the present invention.
  • 17 is a schematic diagram of the external structure of the assembly of the rattle cylinder and the push rod in a specific embodiment of the present invention.
  • FIG. 18 is a schematic diagram of the external structure of the inner tube in a specific embodiment of the present invention.
  • 19 is a schematic diagram of the assembly structure of the inner tube, the sounding cylinder and the push rod in a specific embodiment of the present invention.
  • Figure 20 is a schematic diagram of the internal structure of the inner tube, the sound cylinder, and the push rod assembled in a specific embodiment of the present invention
  • 21 is a schematic diagram of the positional relationship between the inner pipe and the rear end flange in a specific embodiment of the present invention.
  • 22 is a schematic diagram of the axial limit of the inner tube and the push rod in a specific embodiment of the present invention.
  • FIG. 23 is a schematic diagram of the external structure of the release ring in a specific embodiment of the present invention.
  • 24 is a schematic diagram of the internal structure of the release ring, the inner tube, and the push rod assembled in a specific embodiment of the present invention
  • 25 is a schematic diagram of the external structure of the release ring, the inner tube, and the push rod assembled in a specific embodiment of the present invention
  • Figure 26 is a schematic diagram of the axial limit of the release ring and the rattle cylinder in a specific embodiment of the present invention.
  • FIG. 27 is a schematic structural diagram of a push rod spring in a specific embodiment of the present invention.
  • FIG. 29 is a schematic structural diagram of a rear casing in a specific embodiment of the present invention.
  • FIG. 30 is a schematic diagram of the assembly structure of the rear casing and the inner tube in a specific embodiment of the present invention.
  • FIG. 31 is a schematic structural diagram of a return spring in a specific embodiment of the present invention.
  • 32 is a schematic structural diagram of the automatic injector in a specific embodiment of the present invention after the needle cap is removed;
  • FIG. 33 is a schematic structural diagram of the needle tip exposed after the needle guard is retracted in a specific embodiment of the present invention.
  • Figure 34 is a first longitudinal cross-sectional schematic diagram of the automatic injector in use in a specific embodiment of the present invention.
  • Figure 35 is a second longitudinal cross-sectional schematic diagram of the automatic injector in use in a specific embodiment of the present invention.
  • Fig. 36 is the third longitudinal cross-sectional schematic diagram of the automatic injector in the specific embodiment of the present invention during use;
  • Fig. 37 is the fourth longitudinal cross-sectional schematic diagram of the automatic injector in the specific embodiment of the present invention during use;
  • Fig. 38 is the fifth longitudinal cross-sectional schematic diagram of the automatic injector in the specific embodiment of the present invention during use;
  • Fig. 39 is the sixth longitudinal cross-sectional schematic diagram of the automatic injector in use in the specific embodiment of the present invention.
  • FIG. 40 is a schematic longitudinal cross-sectional view of the automatic injector in a specific embodiment of the present invention after use;
  • FIG. 41 is an enlarged view of a partial longitudinal section of the automatic injector in the specific embodiment of the present invention after use.
  • the present invention provides an automatic injector, including: a housing 1, a needle guard 2, a push rod 3, a rattle 4, an inner tube 5, a release ring 6, a driving elastic member, and a reset elastic member pieces.
  • the auto-injector can pre-assemble the pre-filled syringe 9 into the housing 1 during assembly, and then leave the factory as a syringe containing a pre-filled syringe.
  • the housing 1 is the main support and protection component of the entire automatic injector, used to fix components such as the syringe 9, the inner tube 5, etc., and also provide space for other components to install and act.
  • the housing 1 can be designed as shown in the figure.
  • the hollow cylindrical structure shown in Figure 1 can also be designed with an ergonomic adaptation structure on the outside of the housing 1 that is more convenient for human hands to hold. The user holds the housing 1 for pressing operations during injection.
  • the casing 1 is provided with a needle cylinder fixing structure for fixing the needle cylinder 9, and the front end of the casing 1 is provided with an opening for the needle head 91 to extend; the inner side of the casing 1 is sequentially slidable from the rear end to the front end.
  • Needle guard 2 the needle guard 2 can protrude from the front end of the housing 1 and can slide to the rear end relative to the housing 1 and push the release ring 6, the reset elastic piece acts on the release ring 6 and drives the release ring 6 to push the needle guard
  • the cover 2 slides toward the front end of the housing 1 ;
  • the housing 1 is provided with a needle guard limiting structure for limiting the forward sliding distance of the needle guard 2 relative to the housing 1 .
  • the limiting structure of the needle guard includes a first limiting step 111 provided on the inner wall of the housing 1 and a second limiting step 22 provided on the outer wall of the needle guard 2. As shown in FIG. 7, the needle guard is limited The structure is used to prevent the needle guard 2 from coming out of the housing 1 .
  • the limiting structure of the needle guard can also be designed in other shapes.
  • the inner wall of the front part of the housing 1 is designed to be a tapered inner wall that gradually decreases from the rear end to the front end, and the outer wall of the needle guard 2 is designed to match the inner wall.
  • the matching tapered outer wall can prevent the needle guard 2 from coming out; or a limit stop pin and other structures are designed between the needle guard 2 and the inner wall of the housing 1, which can also play a limiting role.
  • the front end mentioned in this solution refers to the end of the automatic injector that is injected toward the human body when in use, that is, the end of the automatic injector that extends out of the needle 91 , when the automatic injector does not contain the syringe 9 and the needle 91 , the front end refers to the end of the needle guard 2 protruding from the housing 1 ; the rear end in this solution is opposite to the aforementioned front end, that is, the other end of the automatic injector that is opposite to the front end.
  • the push rod 3 is the main component used to directly push the piston 93 to realize automatic injection.
  • the push rod 3 is slidably arranged inside the housing 1 along the axial direction, and the front end of the push rod 3 is used to push the piston 93 in the syringe 9 to drive the
  • the elastic piece acts on the push rod 3 and drives the push rod 3 to slide toward the front end of the syringe 9, so that the push rod 3 can automatically complete the injection action under the elastic force of the driving elastic piece, and the driving elastic piece and the push rod 3 can be connected to other components. It is kept in the initial assembled state under the limiting action of the cylinder 9 to avoid the liquid medicine in the syringe 9 being pushed out by the push rod 3.
  • the outer periphery of the push rod 3 is provided with a push rod limit structure, and the push rod limit structure is used to interact with other components. act to keep the push rod 3 in the initial assembled state.
  • the rattle 4 is the main action component that sends out a prompt signal after the push rod 3 is injected.
  • the rattle 4 is sleeved on the outer periphery of the push rod 3 along the axial direction, and the driving elastic piece acts on the rattle 4 and drives the rattle 4 to the shell.
  • the rear end of the body 1 slides, so that the rattle 4 can realize the function of signal prompting under the action of the elastic force of the driving elastic member, and the driving elastic member and the rattle 4 can be kept in the initial assembled state under the restriction of other components to avoid noise.
  • the cylinder 4 slides to the rear end of the housing 1; the clattering cylinder 4 is provided with a push rod limit matching structure; the clattering cylinder 4 and the inner pipe 5 are provided with a clattering cylinder limiting structure, which is used to keep the clattering cylinder in the initial assembly state The relative position between 4 and the inner tube 5 is fixed.
  • the push rod 3 in the present invention can be designed as a solid or hollow rod-shaped structure, or a tubular structure, etc.;
  • the driving elastic member can be a coil spring, elastic rope, metal shrapnel, etc.
  • the push rod 3 is a hollow rod-shaped structure, and the driving elastic member is a push rod spring 7 arranged inside the push rod 3 . Since the push rod spring 7 is in a compressed state, the push rod 3 can be pressurized toward the front end of the housing 1 , and at the same time, a pressure toward the rear end of the housing 1 can be exerted on the rattle 4 .
  • the push rod 3 will move to the front end of the housing 1 under the elastic force of the push rod spring 7, and push the piston 93 for injection;
  • the cylinder 4 will move towards the rear end of the housing 1 under the elastic force of the push rod 7, and a prompt signal will be issued at the same time.
  • a spring guide rod 71 is slidably disposed inside the push rod 3 , the push rod spring 7 is sleeved on the outer circumference of the spring guide rod 71 , and the rear end of the push rod spring 7 abuts against the guide rod end of the rear end of the spring guide rod 71 . 711, the front end of the push rod spring 7 is in contact with the front end of the push rod 3, and the spring guide rod 71 acts as a guide for the push rod spring 7. Therefore, the push rod spring 7 can follow the spring guide during the compression, reset and release process.
  • the rod 71 performs telescopic motion, thereby reducing the twist amount of the push rod spring 7 and ensuring the smooth expansion and contraction of the push rod spring 7 .
  • the inner tube 5 is a tubular part fixed in position relative to the housing 1 , which can provide guidance for the axial movement of the rattle tube 4 .
  • the inner tube 5 can act together with the release ring 6 in the initial assembly state to fix the push rod 3 and the rattle 4, and can release the push rod 3 after the release ring 6 moves to the rear end, so as to realize the automatic injection function of the push rod 3 .
  • the inner tube 5 is fixed inside the housing 1 and is sleeved on the outer circumference of the rattle 4, the release ring 6 is slidably sleeved on the outer circumference of the inner tube 5, and the inner tube 5 is provided with a first clip 55 that can elastically move in the radial direction, The first clip 55 is deflected radially outward under the action of its own elastic force, so that the first clip 55 can release the axial fixation of the push rod 3 in time after losing the limiting effect of the release ring 6, thereby realizing Automatic injection.
  • the release ring 6 When the auto-injector is in the initial assembled state, that is, the state before injection, the release ring 6 is in a position that can press the first clip 55 radially toward the ratchet 4 and the push rod 3, that is, the first clip 55 Under the limiting action of the inner wall of the release ring 6, it can be displaced radially inward, and the push rod 3 can be clamped and limited by the push rod limit matching structure and the push rod limit structure, so that the push rod 3 can be fixed by the first clip 55. to avoid axial movement of the push rod 3 before injection.
  • the push rod limit structure can be designed as a pit structure, a groove structure or a sawtooth structure that can limit the axial position with the first clip 55, etc.
  • the push rod limit structure in this solution is designed to surround The push rod ring groove 31 provided on the outer circumference of the push rod 3 is shown in FIG. 12 to FIG. 14 .
  • the push rod limiting structure is used to provide an avoidance space for the snap fit between the first clip 55 and the push rod limiting structure, or to transmit the clamping force of the first clip 55 to the push rod limiting structure.
  • the push rod limit matching structure is a squeak avoidance notch 42 formed on the side wall of the squeak 4, and the squeak 42 extends along the axial direction of the squeak 4, as shown in FIG. 15 and FIG. 17 .
  • the rattle tube limit structure can limit the relative sliding of the rattle tube 4 and the inner tube 5 under the support of the outer wall of the push rod 3, and the push rod 3 can be separated from the limit structure of the rattle tube after sliding a preset distance to the front end. support, so that the push rod 3 can release the axial fixation of the sounding cylinder 4 after the injection of the preset amount of medicinal liquid or the injection is completed, so that the driving elastic member can push the sounding cylinder 4 to the rear end of the housing 1, and at the same time Send an alert signal.
  • the clattering tube limiting structure can be designed in the form of a pin, a bump, a sawtooth, etc.
  • the clattering cylinder limiting structure in this solution includes a clattering cylinder bump 41 arranged on the outer wall of the clattering cylinder 4 and an inner tube
  • the inner tube clamping hole 53 on the 5 is used to limit the clamping connection with the sounding cylinder protrusion 41, as shown in FIG. 15 to FIG. 19 .
  • the ratchet 4 can be moved to the rear end of the housing 1 under the driving of the driving elastic member by releasing the support for the limiting structure of the rattle.
  • different types of prompt signals can be issued in various ways to remind the user that the injection is completed.
  • a sound prompt signal can be sent out through the mutual collision between the rattle 4 and a structure in the rear end direction of the housing 1; A through hole is opened at the rear end of the shell 1 and the rattle 4 can slide out of the through hole, so that the user's hand can be hit and a tactile reminder signal is generated; or a buzzer or a prompt can be triggered when the ratchet 4 slides to a certain position lights, so as to achieve sound or light prompts, and so on.
  • a voice prompt is used to remind the user that the injection is completed.
  • the signal structure may be an end plate structure at the rear end of the casing 1 , or a press sounding structure disposed at the rear end of the casing 1 , or a metal sheet, or the like.
  • the signal structure in this solution is the end plate 120 fixed to the rear end of the housing 1, as shown in Figures 29 and 30, after the injection of the push rod 3 is completed, the rattle 4 hits the end plate 120 backwards, At the same time, an impact sound is emitted to remind the user.
  • the end plate 120 is designed as a structure with relatively high rigidity, such as a glass plate, a resin plate, a metal plate, etc., or the end plate 120 and the sound barrel 4 are on the opposite side It is designed with a metal sheet or glass sheet with high rigidity, so that when the two collide with each other, a clear and easy-to-recognize prompt sound signal can be issued.
  • the needle 91 in the automatic injector containing the pre-filled syringe 9 in the initial assembly state, in order to protect the needle 91 from external pollution, the needle 91 can be protected by the needle sheath 92 that comes with the syringe 9, and the needle 91 can be protected.
  • the needle sheath 92 and the needle 91 can be secondary protected by designing other protective structures at the front end of the automatic injector.
  • the protective structure can also limit and protect the above-mentioned needle guard 2 to avoid accidental triggering of the automatic injection function.
  • the automatic injector provided in this solution further includes a needle cap 14 , and the needle cap 14 is detachably connected to the front end of the needle guard 2 . Before injection is required, the user can manually pull out the needle cap 14 , so that the needle guard 2 can move toward the rear end of the housing 1 under a pressing action and expose the needle 91 or the needle sheath 92 .
  • the rear end of the needle cap 14 is provided with a hook 143 for mutually engaging with the rear end of the needle sheath 92 , and the hook 143 can exert a pulling force on the needle sheath 92 towards the front end. As shown in FIGS.
  • the needle cap 14 has a cylindrical structure as a whole, and the inner side of the needle cap 14 is provided with a needle cap inner cylinder 145 , and the inner circle of the needle cap inner cylinder 145 forms a needle for accommodating the needle sheath 92
  • the sheath mounting hole 141, the front end of the needle cap inner cylinder 145 and the front end of the needle cap outer cylinder are fixedly connected or designed as an integral structure, the rear end of the needle cap inner cylinder 145 is provided with one or more pairs of hook claws 143, the hook claws 143 are The elastic hook-like structure extends from the side wall of the needle cap inner cylinder 143 to the inside of the needle sheath mounting hole 141.
  • the rear of the hook 143 is installed.
  • the end surface is designed as a guiding slope gradually approaching the center of the inner barrel 145 of the needle cap from back to front, as shown in FIG. 4 and FIG. 5 .
  • the hook 143 can be clamped into the rear end face of the needle sheath 92 from the front end to the rear end.
  • the hook 143 can be used to apply a pulling force to the needle sheath 92, thereby The needle sheath 92 is released from the needle 91 .
  • the hook claws 143 extend inward and toward the front end of the needle cap 14 , so that the needle sheath 92 can be hooked more firmly and the needle sheath 92 can be effectively removed.
  • a space for inserting the front end of the needle guard 2 is reserved between the outer cylinder of the needle cap 14 and the inner cylinder 145 of the needle cap.
  • the inner ring of the needle cap 14 and the circumferential direction of the needle guard 2 are provided with an anti-removal concave-convex matching structure, which can prevent the needle cap 14 from accidentally detaching from the housing 1 or the needle guard before using the syringe.
  • an anti-separation concave-convex matching structure is provided between the inner wall of the outer cylinder of the needle cap 14 and the outer wall of the needle guard 2 .
  • the two can be interchanged, that is, the needle cap anti-disconnection limiting portion 142 is a concave structure, and the needle guard anti-disconnection limiting portion 21 is a convex structure, which can also play the role of preventing and limiting the position.
  • the anti-falling concave-convex matching structure can also be arranged between the inner cylinder 145 of the needle cap and the needle guard 2 , which will not be repeated herein.
  • a needle cap limiting structure 144 is provided between the housing 1 and the needle cap 14 for restricting the movement of the needle cap 14 in the rearward direction relative to the housing 1 .
  • the needle cap limiting structure 144 is specifically designed as a convex structure fixed to the rear end of the outer cylinder of the needle cap 14 , and the front end of the housing 1 is designed with a groove structure matched with it.
  • the needle cap limiting structure 144 cooperates with the groove structure, which can not only restrict the movement of the needle cap 14 to the rear end relative to the housing 1, but also restrict the rotation of the needle cap 14 relative to the housing 1 in the circumferential direction.
  • the needle cylinder fixing structure is a needle cylinder fixing cylinder 110 fixed on the inner side of the housing 1 , and the front end of the needle cylinder fixing cylinder 110 is provided with a needle for limit matching with the front end shoulder of the needle cylinder 9
  • the barrel clamp 112, the main body of the syringe 9 is accommodated in the inside of the syringe fixing barrel 110, and the front shoulder of the syringe 9 abuts against the syringe clamp 112.
  • the syringe 9 can be stably fixed to the syringe
  • the fixed cylinder 110 does not shake, and also prevents the rear end flange 94 of the needle cylinder 9 from breaking so that the needle cylinder 9 is pressed out of the housing 1 .
  • the syringe fixing structure in the present invention can also be designed as a syringe fixing ring fixed on the inner side of the housing 1 or a syringe fixing step and other structures, which will not be described in detail herein.
  • the rear end of the needle cylinder fixing cylinder 110 is provided with a support body 114 for cooperating with the rear end flange 94 of the needle cylinder 9 in a limited position.
  • An elastic spacer 113 is provided between the front end surfaces of the end flanges 94 . Its main function is to provide an elastic support for the needle barrel 9 during the injection process, so as to avoid the bursting of the glass needle barrel 9 due to the excessive thrust released instantaneously.
  • the front end of the inner tube 5 abuts against the rear end surface of the rear end flange 94 of the syringe 9 , and the rear end of the inner tube 5 abuts against the rear end of the housing 1 .
  • the inner tube 5 is fixed inside the housing 1 through the abutting action of both ends, and provides stable support for the syringe 9 .
  • the front end 52 of the inner tube of the inner tube 5 is in contact with the rear end flange 94 of the syringe 9, and the front end 52 of the inner tube can be designed as an elastic support foot structure, and the front end of the inner tube can be designed as an elastic support foot structure.
  • the rear end of the housing 1 is provided with an annular protrusion 121 coaxially cooperating with the rear end of the inner tube 5 , and between the side wall of the housing 1 and the inner tube 5 is provided a rotation for preventing the inner tube 5 from rotating Limit structure.
  • the annular protrusion 121 is used to ensure that the inner tube 5 does not shake in the casing 1, thereby providing a stable sliding support for the release ring 6 and the rattle 4 and other components, and can also be used to ensure that the inner tube 5 and the casing
  • the rotation limiting structure ensures that the inner tube 5 will not rotate relative to the casing 1 .
  • the rotation limit structure can be designed in various structural forms, for example, a limit block structure is arranged between the side wall of the housing 1 and the inner tube 5, or a limit groove structure is arranged, or the end section of the inner tube 5 is arranged
  • the outer contour of the inner tube 5 is designed to be square, oval and other non-circular structures, and the rotation of the inner tube 5 is restricted by the shape fit, and so on.
  • an inner tube anti-rotation limiting groove 122 is designed on the inner wall of the housing 1, which can be specifically designed as a T-shaped notch groove, and the front end of the inner tube 5 is designed with a corresponding inner tube anti-rotation protrusion. 51, as shown in Figures 29 and 30.
  • the housing 1 of the automatic injector provided by the present invention can be designed as an integral structure, or can be designed as a split structure, for example, it is divided into two or more sections of cylindrical structure, preferably, as shown in FIG. 1, the shell
  • the body 1 includes a front case 11 and a rear case 12 , and the front case 11 is connected to the front end of the rear case 12 .
  • the front housing 11 mainly provides installation support for the pre-filled syringe 9 and ensures that the needle guard 2 maintains stable axial movement
  • the rear housing 12 mainly provides installation space for other components such as the inner tube 5 and the reset elastic member.
  • the front casing 11 and the rear casing 12 can be connected and fixed in various ways, such as screw connection, snap connection, etc.
  • a rear casing installation ring groove 123 is designed at the front end of the rear casing 12 , used to connect and fix the front housing 11, as shown in Figure 29.
  • the housing 1 is of a split design, and the syringe assembly manufacturer assembles the pre-filled syringe 9 into the housing 1, and then assembles the front housing 11 and the front housing 11.
  • the rear casing 12 is connected and fixed.
  • the solution also designs a tamper-proof structure at the connection between the front casing 11 and the rear casing 12, for example, by using an adhesive fixing method or an interference fit method. Or the connection between the two is designed as a one-time connection structure that is easily broken, and cannot be connected again after being disassembled, and so on.
  • both the housing 1 and the needle guard 2 are provided with an observation window 13 extending in the axial direction, that is, opened on the side walls of the housing 1 and the needle guard 2 cutout opening.
  • the observation window 13 can also be designed as a transparent cover structure, or the parts located on the outer periphery of the syringe 9 such as the housing 1, the needle guard 2, and the syringe 9 itself can be designed as transparent structures, which can also be easily used. Observe the injection situation.
  • the release ring 6 is a sliding part with a cylindrical structure, and its main function is to limit the first clip 55 of the inner tube 5 to bounce outwards in the initial assembly state, so as to ensure that the push rod 3 is fixed before injection. After the 6 moves toward the rear end of the housing 1 and the release ring 6 releases the radial restriction on the first clip 55, the first clip 55 can release the axial restriction on the push rod 3. Therefore, the push rod 3 can be released.
  • the automatic injection is realized under the action of the push rod spring 7 .
  • Another function of the release ring 6 is to interact with the ratchet 4 after the injection is completed and return to the initial axial position, thereby ensuring that the syringe will not be reused.
  • the needle guard 2 drives the release ring 6 to overcome the elastic force of the reset elastic member together, so that the release ring 6 slides toward the rear end of the housing 1.
  • the inner tube 5 is provided with an inner tube avoidance slot 54 extending along the axial direction
  • the release ring 6 is provided with a second clip 62 slidably matched with the inner tube avoidance slot 54 , and the second clip 62 can interact with the rattle 4
  • a clip limiting structure for restricting the movement of the second clip 62 to the rear end direction of the housing 1 is provided on the outer side of the sound barrel 4 .
  • the second clip 62 can be designed as an elastic clip structure that can elastically deform in the radial direction, and the second clip 62 can interact with the rattle 4 to make the two abut or rub against each other in the axial direction Wait.
  • the ratchet 4 moves to the rear end of the housing 1, and the front end of the needle guard 2 is moved away from the injection part.
  • the second clip 62 of 6 moves to interact with the clip limit structure of the rattle 4, due to the axial limit effect of the clip limit structure and the second clip 62, the release ring 6 cannot move to the shell again.
  • the rear end of the body 1 moves in the direction of the rear end, thus further making the automatic injector unable to perform secondary injection and ensuring the safety of use.
  • the clip limit structure can be designed into various structural forms, such as a limit hole structure, a limit sawtooth structure, a limit friction surface structure, etc. 15 to 17 and FIG. 26, it can be seen from the illustration that in the initial assembly state, the clip limit opening 43 is located at the front end of the second clip 62, therefore, the clip limit opening 43 The second clip 62 cannot be axially limited. When the injection is completed (as shown in FIG. 26 ), the second clip 62 moves to the front end and is inserted into the clip limit opening 43. At this time, the clip is limited.
  • a clip avoidance opening 44 is also designed on the side wall of the rattle 4, as shown in FIGS. 15 to 17 and 26, the clip The avoidance opening 44 is located in the direction of the rear end of the clip limiting opening 43 .
  • the reset elastic member serves as a retaining member for keeping the release ring 6 and the needle guard 2 in the initial axial position and a restoring member for restoring the release ring 6 and the needle guard 2 to the initial axial position after the injection is completed.
  • the reset elastic member can provide a continuous elastic force applied to the front end direction for the release ring 6.
  • elastic parts such as coil springs, elastic ropes or metal shrapnel can be used.
  • the reset elastic member is a reset spring 8, as shown in Figure 31.
  • the return spring 8 is arranged in compression between the release ring 6 and the housing 1 . As shown in FIG.
  • the rear end of the release ring 6 is also designed with a rear end flange 61 of the release ring for abutting with the return spring 8 , and the front end of the return spring 8 abuts against the rear end flange 61 of the release ring , the rear end of the return spring 8 is in contact with the inner wall of the rear end of the rear housing 12 , and the return spring 8 may also be in a compressed state in the initial assembled state.
  • the needle cap 14, the needle guard 2, the front housing 11 and the elastic spacer 113 described above constitute the holding assembly of the front housing and are mainly used to maintain and fix the position of the needle cylinder 9;
  • the push rod 3, the sounding cylinder 4, the inner tube 5, the release ring 6, the push rod spring 7, the spring guide rod 71, the return spring 8, and the rear casing 12 constitute the driving assembly of the rear casing. It is used to realize the function of driving injection.
  • each part of the automatic injector of the present invention can be made of various materials (such as resin, metal, etc. commonly used in medical equipment), and can also have different specifications and structures.
  • FIGS. 1 to 3 and FIGS. 32 to 41 please refer to FIGS. 1 to 3 and FIGS. 32 to 41 to introduce the complete use process of the automatic injector provided by the present invention.
  • FIGS. 1 to 3 are a schematic diagram of the overall external structure and two longitudinal cross-sectional diagrams of the auto-injector before use, respectively.
  • the needle cap 14 of the auto-injector is also mounted on the front end of the housing 1 .
  • the front housing 11 is adapted to hold a syringe 9 containing a medicament.
  • the syringe 9 may be a pre-filled syringe and has a needle 91 disposed at the front end of the syringe 9.
  • the syringe 9 may be suitable for A medicament cartridge to which needle 91 is removably attached.
  • the needle 91 is arranged towards the front opening of the front housing 11, and the needle 91 can be protected by a needle sheath 92.
  • the needle guard 2 protrudes from the front end of the housing 1 and can protect the needle 91 and the needle sheath 92 .
  • the needle cap 14 when preparing for injection, the needle cap 14 is removed to the front, and the front end of the needle guard 2 is exposed outside the housing 11, and the needle 91 is still covered by the needle guard 2. Then, hold the housing 1 and make the front end of the housing 1 align with the part of the body that needs to be injected, align the needle guard 2 with the part that needs to be injected and press it hard, at this time, the needle guard 2 shrinks to the inside of the housing 1, And the needle 91 is exposed, so that the needle 91 can pierce the site to be injected.
  • the needle guard 2 When the needle guard 2 is pushed backwards, the rear end surface of the needle guard 2 will abut the front end of the release ring 6 , the needle guard 2 overcomes the elastic force of the return spring 8 and drives the release ring 6 to the rear end relative to the housing 1 . Move and compress the return spring 8 until the second clip 62 of the release ring 6 abuts against the inner tube escape slot 54 of the inner tube 5 , as shown in FIGS. 33 to 35 . At the same time, the inner ring protrusion 23 of the needle guard provided on the inner wall of the needle guard 2 will abut against the needle cylinder clamping claw 112 inside the front housing 11 to provide auxiliary support for the shoulder of the front end of the needle cylinder 9 .
  • the outer wall of the push rod 3 can provide continuous support to the rattle cylinder bump 41, thereby ensuring that the positions of the rattle cylinder 4 and the inner tube 5 are relatively fixed; and when the push rod 3 slides a preset distance That is, after the push rod 3 injects the preset amount of liquid in the syringe 9 , the rattle cylinder bump 41 is separated from the support of the outer wall of the push rod 3 , so that the rattle cylinder 4 can be moved downward under the action of the push rod spring 7 .
  • the rear end direction of the casing 1 slides.
  • the sounding cylinder 4 can prompt the user to complete the injection through various methods such as sound, light, friction, impact and vibration.
  • the inner ring-shaped protrusions 121 collide with each other to make a sound to prompt the completion of injection, as shown in FIG. 38 and FIG. 39 . The user only needs to pull out the needle 91 from the body to complete the entire injection process.
  • the rattle tube 4 is axially limited by the clip limit opening 43 and cannot move backward again, as shown in Figure 40 and Figure 41, so that the protection can be locked.
  • the axial position of the needle shield 2 prevents the needle 91 from being exposed, that is, prevents the automatic injector from being reused, thereby ensuring high safety in use.
  • the automatic injector provided by this scheme can realize the automatic injection function of the prefilled syringe through eight parts. Compared with the automatic injector in the prior art, this scheme has a simple structure and a small number of parts;

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Abstract

一种自动注射器，包括：壳体（1）、护针罩（2）、推杆（3）、响筒（4）、内管（5）、释放环（6）、驱动弹性件、复位弹性件。使用时，针筒（9）固定于壳体（1）内，针头（91）伸出于壳体（1）前端，护针罩（2）可伸缩连接于壳体（1），护针罩（2）可推动释放环（6）向壳体（1）后端滑动，释放环（6）向后端移动后，内管（5）的第一卡夹（55）释放对推杆（3）的卡接限位，推杆（3）在驱动弹性件的作用下推动活塞（93）将针筒（9）内的液体注射到身体需要注射的部位，实现自动注射的目的。注射完毕后，响筒（4）脱离内管（5）的限位并且向壳体（1）后端滑动，以便于发出注射完毕的信号。本方案提供的自动注射器通过八个零部件即可实现预灌封针筒的自动注射功能，相对于现有技术，本方案结构简单、零件数目少、机构动作原理简单、可靠度高。

Description

一种自动注射器
本申请要求于2020年10月16日提交中国专利局、申请号为202011110579.9、发明名称为“一种自动注射器”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
本申请要求于2020年10月16日提交中国专利局、申请号为202022322096.7、发明名称为“一种自动注射器”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本发明涉及医疗器械技术领域，尤其涉及一种自动注射器。
背景技术
自动注射器是一种可以将预灌封注射筒内的液体药物自动注射到患者体内的医疗器械，可以满足使用者自我给药的需求。自动注射器是一种患者自用式的医疗器械，由于一般患者并非专业的医护人员，因此，通常要求自动注射器具有简单易用、可靠性高、体验舒适等特点，并且能够在注射完毕后发出提示信号以帮助提示使用者确认注射完毕。
现有的自动注射器在使用时，一般通过将针筒的前端简单地压靠在需要注射的部位并需要手执针筒后端进行移动来实现穿刺和注射。当自动注射器的前端定位于患者的注射部位时，自动注射器上的启动部件被按压，以激活自动注射器，针头即可迅速穿刺皮肤，药物经针头进行自动注射。
然而，现有的自动注射器结构较为复杂，内部零件数量较多，易造成产品功能失效，导致产品可靠性较差，产品加工和组装工序较多，使得产品成本较高。
因此，如何提高自动注射器的可靠性，是本领域技术人员目前需要解决的技术问题。
发明内容
有鉴于此，本发明的目的在于提供一种自动注射器，该自动注射器结构简单、可靠性高，产品易于组装，成本较低。
为了实现上述目的，本发明提供了如下技术方案：
一种自动注射器，包括：壳体、护针罩、推杆、响筒、内管、释放环、驱动弹性件、复位弹性件；
所述壳体内设有用于固定针筒的针筒固定结构，所述壳体的前端设有供针头伸出的开口；
所述壳体内侧由后端至前端方向依次滑动设置有所述释放环和所述护针罩，所述护针罩能够伸出于所述壳体的前端且能够相对所述壳体向后端滑动并推动所述释放环，所述复位弹性件作用于所述释放环并驱使所述释放环推动所述护针罩向所述壳体的前端滑动；所述壳体设置有用于限定所述护针罩相对所述壳体向前的滑动距离的护针罩限位结构；
所述推杆沿轴向滑动设置于所述壳体内部，且所述推杆的前端用于推动所述针筒内的活塞，所述驱动弹性件作用于所述推杆并驱使所述推杆向所述针筒的前端滑动，所述推杆的外周设有推杆限位结构；
所述响筒沿轴向滑动套设于所述推杆的外周，所述驱动弹性件作用于所述响筒并驱使所述响筒向所述壳体的后端滑动，所述响筒设有推杆限位配合结构，所述响筒与所述内管之间设有响筒限位结构；
所述内管固定于所述壳体内部并且套设于所述响筒的外周，所述释放环滑动套设于所述内管的外周，所述内管设有能够沿径向弹性移动的第一卡夹，所述第一卡夹在自身弹力作用下沿径向向外偏移；
所述第一卡夹能够在所述释放环的内壁的限位作用下沿径向向内偏移并通过所述推杆限位配合结构与所述推杆限位结构相互卡接限位，所述响筒限位结构能够在所述推杆的外壁的支撑作用下限制所述响筒与所述内管的相对滑动，所述推杆能够在向前端滑动预设距离后脱离对所述响筒限位结构的支撑。
优选地，所述壳体的后端设有用于与所述响筒撞击限位的信号结构。
优选地，所述信号结构为固定于所述壳体的后端的端板。
可选地，还包括针帽，所述针帽可拆卸地连接于所述护针罩的前端。
优选地，所述针帽的后端设有用于与针鞘的后端相互卡接的勾爪，所述勾爪能够对所述针鞘施加向前端方向的拉力作用。
优选地，所述针帽的内圈与所述护针罩的周向之间设有防脱凹凸配合结构。
优选地，所述壳体与所述针帽之间设有用于限制所述针帽相对所述壳体向 后端方向移动的针帽限位结构。
优选地，所述针筒固定结构为固定于所述壳体内侧的针筒固定筒，所述针筒固定筒的前端设有用于与所述针筒的前端肩部限位配合的针筒夹爪。
优选地，所述针筒固定筒的后端设有用于与所述针筒的后端法兰限位配合的支撑体，所述支撑体与所述针筒的后端法兰的前端面之间设有弹性垫块。
优选地，所述内管的前端抵接于所述针筒的后端法兰的后端面，所述内管的后端抵接于所述壳体的后端。
优选地，所述壳体的后端设有与所述内管的后端同轴配合的环状凸起，所述壳体的侧壁与所述内管之间设有用于防止所述内管旋转的旋转限位结构。
优选地，所述推杆限位配合结构为开设于所述响筒的侧壁上的响筒避让缺口，所述响筒避让缺口沿所述响筒的轴向延伸布置。
优选地，所述响筒限位结构包括设置于所述响筒外壁的响筒凸块以及开设于所述内管上的用于与所述响筒凸块限位卡接的内管卡孔。
优选地，所述内管设有沿轴向延伸的内管避让槽孔，所述释放环设有与所述内管避让槽孔滑动配合的第二卡夹，且所述第二卡夹能够与所述响筒相互作用，所述响筒的外侧设有用于限制所述第二卡夹向所述壳体的后端方向移动的卡夹限位结构。
优选地，所述推杆为中空的杆状结构，所述驱动弹性件为设置于所述推杆内部的推杆弹簧，所述推杆弹簧压缩布置于所述推杆的前端和所述响筒的后端之间。
优选地，所述推杆的内部滑动设置有弹簧导杆，所述推杆弹簧套设于所述弹簧导杆的外周。
优选地，所述复位弹性件为复位弹簧，所述复位弹簧压缩布置于所述释放环和所述壳体之间。
优选地，所述壳体包括前壳体和后壳体，所述前壳体连接于所述后壳体的前端。
优选地，所述壳体和所述护针罩均设有沿轴向延伸的观察窗口。
优选地，所述护针罩限位结构包括设置于所述壳体内壁的第一限位台阶和设置于所述护针罩外壁的第二限位台阶。
本发明提供的自动注射器的工作原理如下：
该自动注射器的壳体内部可以预先安装固定有预灌封的针筒，针头朝壳体 的前端开口布置，针头可由针鞘保护，在注射之前的初始组装状态时，护针罩伸出于壳体的前端并能够保护针头和针鞘。
需要注射时，取下保护针头的针鞘，然后，手持壳体并使壳体的前端对准身体需要注射的部位，将护针罩对准需要注射的部位并用力按压，此时，护针罩克服复位弹性件的弹力并带动释放环一同相对壳体向后端移动，从而使针头能够刺入需要注射的部位。在释放环向壳体后端移动的过程中，内管的第一卡夹脱离释放环的内壁的限位，从而释放对推杆的卡接限位，推杆在驱动弹性件的作用下向针筒的前端滑动，并通过活塞将针筒内的液体经针头注射到身体内，从而实现自动注射。
在推杆注射过程中，推杆的外壁能够对响筒限位结构提供持续的支撑作用，从而保证响筒与内管的位置相对固定；而当推杆滑动预设距离后，即，推杆将针筒内的预设量的液体注射完毕后，响筒限位结构脱离推杆的外壁的支撑，从而使得响筒能够在驱动弹性件的作用下向壳体的后端滑动。响筒在滑动过程中或者在滑动一定距离后，可以通过发声、发光、撞击振动等多种方式提示使用者注射完毕。使用者只需将针头从身体拔出即可完成整个注射过程。
本发明方案具有以下有益效果：
1)本方案提供的自动注射器通过八个零部件即可实现预灌封针筒的自动注射功能，相对于现有技术中的自动注射器，本方案结构简单，零件数目少；
2)本方案通过按压方式即可实现自动注射的功能，机构动作原理简单、可靠度高；
3)产品易于组装，降低人工组装成本，提高产品良率。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本发明具体实施例中的自动注射器的整体外部结构示意图；
图2为本发明具体实施例中的自动注射器的第一内部结构示意图；
图3为本发明具体实施例中的自动注射器的第二内部结构示意图；
图4为本发明具体实施例中的针帽与针筒、针鞘位置关系示意图；
图5为本发明具体实施例中的针帽的结构示意图；
图6为本发明具体实施例中的针帽与前壳体限位组装示意图；
图7为本发明具体实施例中的护针罩与前壳体轴向限位示意图；
图8为本发明具体实施例中的护针罩与针帽轴向限位示意图；
图9为本发明具体实施例中的前壳体与针筒肩部定位示意图；
图10为本发明具体实施例中的垫块与后端法兰的位置关系示意图；
图11为本发明具体实施例中的垫块与前壳体的位置关系示意图；
图12为本发明具体实施例中的推杆的外部结构示意图；
图13为本发明具体实施例中的推杆的中空结构示意图；
图14为本发明具体实施例中的推杆与推杆弹簧组装结构示意图；
图15为本发明具体实施例中的响筒的外部结构示意图；
图16为本发明具体实施例中的响筒与推杆组装的内部结构示意图；
图17为本发明具体实施例中的响筒与推杆组装的外部结构示意图；
图18为本发明具体实施例中的内管的外部结构示意图；
图19为本发明具体实施例中的内管与响筒、推杆组装结构示意图；
图20为本发明具体实施例中的内管与响筒、推杆组装内部结构示意图；
图21为本发明具体实施例中的内管与后端法兰位置关系示意图；
图22为本发明具体实施例中的内管与推杆轴向限位示意图；
图23为本发明具体实施例中的释放环的外部结构示意图；
图24为本发明具体实施例中的释放环与内管、推杆组装的内部结构示意图；
图25为本发明具体实施例中的释放环与内管、推杆组装的外部结构示意图；
图26为本发明具体实施例中的释放环与响筒轴向限位示意图；
图27为本发明具体实施例中的推杆弹簧的结构示意图；
图28为本发明具体实施例中的弹簧导杆的结构示意图；
图29为本发明具体实施例中的后壳体的结构示意图；
图30为本发明具体实施例中的后壳体与内管组装结构示意图；
图31为本发明具体实施例中的复位弹簧的结构示意图；
图32为本发明具体实施例中的自动注射器在拔除针帽之后的结构示意图；
图33为本发明具体实施例中的护针罩缩回后露出针头的结构示意图；
图34为本发明具体实施例中的自动注射器在使用过程中的第一纵截面示意图；
图35为本发明具体实施例中的自动注射器在使用过程中的第二纵截面示意图；
图36为本发明具体实施例中的自动注射器在使用过程中的第三纵截面示意图；
图37为本发明具体实施例中的自动注射器在使用过程中的第四纵截面示意图；
图38为本发明具体实施例中的自动注射器在使用过程中的第五纵截面示意图；
图39为本发明具体实施例中的自动注射器在使用过程中的第六纵截面示意图；
图40为本发明具体实施例中的自动注射器在使用完毕后的纵截面示意图；
图41为本发明具体实施例中的自动注射器在使用完毕后的局部纵截面放大图。
图1至图41中的各项附图标记的含义为：
1-壳体、11-前壳体、12-后壳体、13-观察窗口、110-针筒固定筒、111-第一限位台阶、112-针筒夹爪、113-弹性垫块、114-支撑体、120-端板、121-环状凸起、122-内管防转限位槽、123-后壳体安装环槽；
14-针帽、141-针鞘安装孔、142-针帽防脱限位部、143-勾爪、144-针帽限位结构、145-针帽内筒；
2-护针罩、21-护针罩防脱限位部、22-第二限位台阶、23-护针罩内圈凸起；
3-推杆、31-推杆环槽；
4-响筒、41-响筒凸块、42-响筒避让缺口、43-卡夹限位开口、44-卡夹避 让开口；
5-内管、51-内管防转凸起、52-内管前端、53-内管卡孔、54-内管避让槽孔、55-第一卡夹；
6-释放环、61-释放环后端凸缘、62-第二卡夹；
7-推杆弹簧、71-弹簧导杆、711-导杆端部；
8-复位弹簧；
9-针筒、91-针头、92-针鞘、93-活塞、94-后端法兰。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
请参照图1至图41，本发明提供了一种自动注射器，包括：壳体1、护针罩2、推杆3、响筒4、内管5、释放环6、驱动弹性件、复位弹性件。该自动注射器可以在组装时将预灌封的针筒9预先组装到壳体1内部，作为含有预灌封针筒的注射器出厂。
其中，壳体1是作为整个自动注射器的主要支撑和保护部件，用于固定针筒9、内管5等部件，同时也为其他部件提供安装和动作的空间，壳体1可设计为如图1中所示的中空的筒状结构，当然，也可以在壳体1外侧设计有更便于人手握持的符合人体工学的适配结构，使用者在注射时手持壳体1进行按压操作。壳体1内设有用于固定针筒9的针筒固定结构，壳体1的前端设有供针头91伸出的开口；壳体1内侧由后端至前端方向依次滑动设置有释放环6和护针罩2，护针罩2能够伸出于壳体1的前端且能够相对壳体1向后端滑动并推动释放环6，复位弹性件作用于释放环6并驱使释放环6推动护针罩2向壳体1的前端滑动；壳体1设置有用于限定护针罩2相对壳体1向前的滑动距离的护针罩限位结构。优选地，护针罩限位结构包括设置于壳体1内壁的第一限位台阶111和设置于护针罩2外壁的第二限位台阶22，如图7所示，护针罩限位结构用于防止护针罩2从壳体1中脱出。当然，护针罩限位结构还可以设计为其他形状结构，例如将壳体1的前段部分的内壁设计成由后端至前端逐渐 缩小的锥形内壁，护针罩2的外壁设计成与之配合的锥形外壁，从而防止护针罩2脱出；或者在护针罩2与壳体1内壁之间设计有限位挡销等结构，同样能够起到限位作用。
需要说明的是，本方案中所述的前端是指该自动注射器在使用时朝向人体注射的一端，即，该自动注射器伸出针头91的一端，当该自动注射器不含有针筒9及针头91时，前端是指护针罩2伸出于壳体1的一端；本方案中所述的后端与前述的前端相对，即，自动注射器的与前端相对的另一端。
推杆3是用于直接推动活塞93以实现自动注射的主要部件，推杆3沿轴向滑动设置于壳体1内部，且推杆3的前端用于推动针筒9内的活塞93，驱动弹性件作用于推杆3并驱使推杆3向针筒9的前端滑动，从而使推杆3能够在驱动弹性件的弹力作用下自动完成注射动作，驱动弹性件和推杆3能够在其他部件的限制作用下保持在初始组装状态以避免针筒9内的药液被推杆3推出，推杆3的外周设有推杆限位结构，该推杆限位结构就是用于与其他部件相互作用以使推杆3保持在初始组装状态。
响筒4是在推杆3注射完毕后发出提示信号的主要动作部件，响筒4沿轴向滑动套设于推杆3的外周，驱动弹性件作用于响筒4并驱使响筒4向壳体1的后端滑动，从而使响筒4能够在驱动弹性件的弹力作用下实现信号提示的功能，驱动弹性件和响筒4能够在其他部件的限制作用下保持在初始组装状态以避免响筒4向壳体1的后端滑动；响筒4设有推杆限位配合结构；响筒4与内管5之间设有响筒限位结构，用于在初始组装状态时保持响筒4与内管5之间的相对位置固定。
需要说明的是，本发明中的推杆3可以设计为实心或空心的杆状结构，或管状结构等；驱动弹性件可以采用螺旋弹簧、弹力绳、金属弹片等，优选地，本方案中的推杆3为中空的杆状结构，驱动弹性件为设置于推杆3内部的推杆弹簧7，推杆弹簧7压缩布置于推杆3的前端和响筒4的后端之间。由于推杆弹簧7处于压缩状态，因此，可以对推杆3施加向壳体1前端方向的压力，同时对响筒4施加向壳体1后端方向的压力，一旦推杆3脱离内管5的轴向限位，推杆3就会在推杆弹簧7的弹力作用下向壳体1前端方向移动，同时推动活塞93进行注射；一旦响筒4脱离内管5的轴向限位，响筒4就会在推杆7的弹力作用下向壳体1后端方向移动，同时发出提示信号。
优选地，推杆3的内部滑动设置有弹簧导杆71，推杆弹簧7套设于弹簧 导杆71的外周，推杆弹簧7的后端抵接于弹簧导杆71后端的导杆端部711，推杆弹簧7的前端则抵接于推杆3的前端，弹簧导杆71作为推杆弹簧7的导引件，因此，推杆弹簧7在压缩及复位释放过程中可以沿着弹簧导杆71进行伸缩运动，从而减小推杆弹簧7的扭曲量，保证推杆弹簧7的顺利伸缩。
内管5是相对壳体1位置固定的一个管状零件，其能为响筒4提供轴向运动的导引。内管5能够在初始组装状态与释放环6一同作用，从而固定推杆3和响筒4，并且能够在释放环6向后端移动后释放推杆3，从而实现推杆3的自动注射功能。内管5固定于壳体1内部并且套设于响筒4的外周，释放环6滑动套设于内管5的外周，内管5设有能够沿径向弹性移动的第一卡夹55，第一卡夹55在自身弹力作用下沿径向向外偏移，从而使得第一卡夹55能够在失去释放环6的限位作用后能够及时解除对推杆3的轴向固定，进而实现自动注射。
在自动注射器处于初始组装状态时，即注射之前的状态时，释放环6所处的位置能够将第一卡夹55沿径向压向响筒4及推杆3，即，第一卡夹55能够在释放环6的内壁的限位作用下沿径向向内偏移并通过推杆限位配合结构与推杆限位结构相互卡接限位，从而利用第一卡夹55固定推杆3的轴向位置，避免推杆3在注射前发生轴向移动。其中，推杆限位结构可以设计成凹坑结构、凹槽结构或能够与第一卡夹55轴向限位的锯齿结构等等，优选地，本方案中的推杆限位结构设计为环绕推杆3的外周设置的推杆环槽31，如图12至图14所示。推杆限位配合结构用于为第一卡夹55与推杆限位结构的卡接配合提供避让空间，或者用于传递第一卡夹55对推杆限位结构的夹持力。优选地，推杆限位配合结构为开设于响筒4的侧壁上的响筒避让缺口42，响筒避让缺口42沿响筒4的轴向延伸布置，如图15和图17所示。
另外，响筒限位结构能够在推杆3的外壁的支撑作用下限制响筒4与内管5的相对滑动，推杆3能够在向前端滑动预设距离后脱离对响筒限位结构的支撑，从而使推杆3在推注预设量药液或推注完毕后能够解除对响筒4的轴向固定，进而使得驱动弹性件能够将响筒4向壳体1后端推动，同时发出提示信号。其中，响筒限位结构可以设计成销、凸块、锯齿等结构形式，优选地，本方案中的响筒限位结构包括设置于响筒4外壁的响筒凸块41以及开设于内管5上的用于与响筒凸块41限位卡接的内管卡孔53，如图15至图19所示。
需要说明的是，当推杆3注射完毕后，可以通过解除对响筒限位结构的支 撑的方式，使响筒4能够在驱动弹性件的驱动下向壳体1后端方向移动，在响筒4移动过程中或移动到指定位置时可以通过多种方式发出不同类型的提示信号，用以提醒使用者注射完毕。例如，可以通过响筒4与壳体1后端方向某结构相互撞击并发出声音提示信号；或者通过响筒4在向后移动过程中与内管5内壁的相互摩擦发出声音提示信号；或者通过在壳体1后端开设通孔并使响筒4能够滑出通孔，从而可以撞击使用者手部并产生触觉提醒信号；或者通过响筒4在滑动至某位置时触发蜂鸣器或提示灯，从而实现声音或灯光提示，等等。优选地，本方案采用声音提示的方式来提醒使用者注射完毕，壳体1的后端设有用于与响筒4撞击限位的信号结构。具体的，该信号结构可以为壳体1后端的端板结构，或者设置于壳体1后端的按压发声结构，或者金属片，等等。优选地，本方案中的信号结构为固定于壳体1的后端的端板120，如图29和图30所示，当推杆3注射完毕后，响筒4向后撞击到端板120，同时发出撞击声音，从而提醒使用者。为了增大撞击声音，便于使用者听觉识别，本方案将端板120设计为刚性较大的结构，例如玻璃板、树脂板、金属板等，或者在端板120和响筒4相向的一侧设计有刚性较高的金属片或玻璃片等，从而使得两者相互撞击时能够发出清脆、易辨识的提示声音信号。
需要说明的是，本方案在初始组装状态含有预灌封的针筒9的自动注射器中，为了保护针头91不受外界污染，可以采用针筒9自带的针鞘92对针头91保护，还可以通过在自动注射器的前端设计其他保护结构，对针鞘92和针头91二次保护，该保护结构还可以对上述护针罩2进行限位和保护，避免意外触发自动注射功能。优选地，如图4所示，本方案提供的自动注射器还包括针帽14，针帽14可拆卸地连接于护针罩2的前端。在需要注射之前，使用者可以手动将针帽14拔除，从而使护针罩2可以在按压动作下向壳体1后端方向移动并露出针头91或针鞘92。
优选地，针帽14的后端设有用于与针鞘92的后端相互卡接的勾爪143，勾爪143能够对针鞘92施加向前端方向的拉力作用。如图4和图5所示，针帽14整体呈筒状结构，且针帽14的内侧贯穿设置有针帽内筒145，针帽内筒145的内圈形成用于容纳针鞘92的针鞘安装孔141，针帽内筒145的前端与针帽外筒的前端固定连接或设计为一体式结构，针帽内筒145的后端设有一对或多对勾爪143，勾爪143为由针帽内筒143的侧壁向针鞘安装孔141的内侧延伸的弹性钩状结构，在组装时为了便于将勾爪143卡入针鞘92的后端，本方 案将勾爪143的后端面设计为由后至前逐渐靠近针帽内筒145中心的引导斜面，如图4和图5所示。在组装自动注射器时，勾爪143可以由前端至后端方向卡入针鞘92后端端面，在使用自动注射器时，拔除掉针帽14时可以利用勾爪143对针鞘92施加拉力，从而使针鞘92脱离针头91。其中，勾爪143向内且向针帽14前端延伸，从而可以更加牢固地钩住针鞘92，保证有效拔除针鞘92。另外，针帽14的外侧筒与针帽内筒145之间还预留有供护针罩2的前端插入的空间。
优选地，针帽14的内圈与护针罩2的周向之间设有防脱凹凸配合结构，在使用注射器之前，该防脱凹凸配合结构可以避免针帽14意外脱离壳体1或护针罩2。具体的，如图4所示，本方案在针帽14的外筒的内壁与护针罩2的外壁之间设有防脱凹凸配合结构，该防脱凹凸配合结构具体包括针帽防脱限位部142和护针罩防脱限位部21，图4所示的针帽防脱限位部142为凸起结构，护针罩防脱限位部21为与之配合的凹陷结构，当然，两者可以互换，即，针帽防脱限位部142为凹陷结构，护针罩防脱限位部21为凸起结构，同样能够起到防脱限位的作用。当然，本发明还可以将防脱凹凸配合结构设置于针帽内筒145与护针罩2之间，本文不再赘述。
优选地，壳体1与针帽14之间设有用于限制针帽14相对壳体1向后端方向移动的针帽限位结构144。如图5和图6所示，针帽限位结构144具体设计为固定于针帽14的外筒的后端的凸起结构，壳体1前端则设计有与其配合的凹槽结构，当针帽14安装于壳体1前端时，针帽限位结构144与凹槽结构配合，不仅可以限制针帽14相对壳体1向后端移动，还可以限制针帽14相对壳体1沿周向转动。
如图9所示，优选地，针筒固定结构为固定于壳体1内侧的针筒固定筒110，针筒固定筒110的前端设有用于与针筒9的前端肩部限位配合的针筒夹爪112，针筒9的主体容纳于针筒固定筒110的内部，针筒9的前端肩部则抵接在针筒夹爪112，在注射时，针筒9能稳定固定在针筒固定筒110内不发生晃动，也防止针筒9的后端法兰94断裂使得针筒9压出壳体1。当然，本发明中的针筒固定结构还可以设计为固定于壳体1内侧的针筒固定环或针筒固定台阶等结构，本文不再赘述。
如图10和图11所示，优选地，针筒固定筒110的后端设有用于与针筒9的后端法兰94限位配合的支撑体114，支撑体114与针筒9的后端法兰94的 前端面之间设有弹性垫块113。其主要功能是在注射过程中为针筒9提供一弹性支撑，避免瞬间释放的推力过大造成玻璃制的针筒9发生破裂。
优选地，内管5的前端抵接于针筒9的后端法兰94的后端面，内管5的后端抵接于壳体1的后端。如此设置，内管5通过两端的抵接作用固定于壳体1内部，并且为针筒9提供稳定支撑。进一步优选地，如图18和图21所示，内管5的内管前端52与针筒9的后端法兰94抵接，其内管前端52可设计为弹性支撑脚结构，内管前端52会持续压在后端法兰94上，提供稳定的压力，使针筒9的后端法兰94可以一直压在弹性垫块113上，同时避免压损后端法兰94。
优选地，壳体1的后端设有与内管5的后端同轴配合的环状凸起121，壳体1的侧壁与内管5之间设有用于防止内管5旋转的旋转限位结构。具体的，环状凸起121用于保证内管5在壳体1内不发生晃动，从而为释放环6和响筒4等部件提供稳固的滑动支撑，还可以用于保证内管5与壳体1的同轴度，此时，当响筒4运动至壳体1的后端时，响筒4的后端会撞击到环状凸起121的前端面，从而发出撞击声音信号以实现提示。旋转限位结构则保证内管5不会相对壳体1发生转动。其中，旋转限位结构可以设计为多种结构形式，例如在壳体1的侧壁与内管5之间布置限位块结构，或者布置限位槽结构，或者将内管5的端部截面的外轮廓设计成方形、椭圆形等非圆形结构，通过型面配合来限制内管5的旋转，等等。优选地，本方案在壳体1的内壁设计有内管防转限位槽122，具体可设计成T型缺口槽，内管5的前端则设计有与之对应配合的内管防转凸起51，如图29和图30所示。
需要说明的是，本发明提供的自动注射器的壳体1可以设计为一体式结构，也可以设计为分体式结构，例如分成两段或多段筒状结构，优选地，如图1所示，壳体1包括前壳体11和后壳体12，前壳体11连接于后壳体12的前端。前壳体11主要为预灌封的针筒9提供安装支撑并确保护针罩2维持稳定的轴向运动，后壳体12主要为内管5和复位弹性件等其他部件提供安装空间。具体的，前壳体11和后壳体12可通过多种方式连接固定，例如螺纹连接、卡扣连接等，优选地，本方案在后壳体12的前端设计有后壳体安装环槽123，用于连接固定前壳体11，如图29所示。进一步优选地，本方案提供的自动注射器在作为半成品出厂时，壳体1为分体设计，注射器组装厂家再将预灌封的针筒9组装到壳体1中，然后将前壳体11和后壳体12连接固定，为了避免使 用者重复利用注射器，本方案还在前壳体11与后壳体12连接处设计有防拆结构，例如采用胶粘固定方式，或者采用过盈配合方式，或者将两者连接处设计为易折断的一次性连接结构，在拆开后无法再次连接到一起，等等。
优选地，为了便于使用者观察推杆3的推注情况，壳体1和护针罩2均设有沿轴向延伸的观察窗口13，即开设于壳体1和护针罩2侧壁上的镂空开口。当然，本发明中还可以将观察窗口13设计为透明盖结构，或者将壳体1、护针罩2等位于针筒9外周的零部件以及针筒9本身设计为透明结构，也能便于使用者观察注射情况。
释放环6是一个呈筒状结构的滑动零件，其主要功能是在初始组装状态限制内管5的第一卡夹55向外弹起，从而保证在注射之前使推杆3固定，当释放环6向壳体1后端方向移动并且释放环6解除对第一卡夹55的径向限制后，可以使第一卡夹55释放对推杆3的轴向限位，因此，推杆3可以在推杆弹簧7的作用下实现自动注射。释放环6的另一个功能是在注射完毕并回到初始轴向位置后能够与响筒4相互作用，从而保证注射器不会被二次利用。
在需要注射时，护针罩2带动释放环6一同克服复位弹性件的弹力，从而使释放环6向壳体1后端方向滑动，为了便于释放环6相对内管5滑动，优选地，内管5设有沿轴向延伸的内管避让槽孔54，释放环6设有与内管避让槽孔54滑动配合的第二卡夹62，且第二卡夹62能够与响筒4相互作用，响筒4的外侧设有用于限制第二卡夹62向壳体1的后端方向移动的卡夹限位结构。其中，第二卡夹62可设计为能够沿径向发生弹性变形的弹性卡夹结构，第二卡夹62能够与响筒4相互作用以使两者在沿轴向方向上相互抵接或摩擦等。当注射完毕后，响筒4移动至壳体1的后端，护针罩2的前端从注射部位移开，此时，释放环6受到复位弹性件的作用而向前端方向移动，当释放环6的第二卡夹62移动至与响筒4的卡夹限位结构相互作用时，由于卡夹限位结构与第二卡夹62的轴向限位作用，使得释放环6无法再次向壳体1后端方向移动，因此，进一步使得该自动注射器无法进行二次注射，保证了使用安全性。其中，卡夹限位结构可以设计成多种结构形式，例如限位孔结构、限位锯齿结构、限位摩擦面结构等，优选地，本方案在响筒4的侧壁设计有卡夹限位开口43，如图15至图17以及图26所示，由图示可见，在初始组装状态下，卡夹限位开口43位于第二卡夹62的前端，因此，卡夹限位开口43无法对第二卡夹62进行轴向限位，当注射完毕后(图26所示)，第二卡夹62向前端方向移动并 卡入卡夹限位开口43内，此时，卡夹限位开口43的后端内侧边缘与第二卡夹62的后端端面相互抵接，从而限制第二卡夹62再次向壳体1后端方向移动。另外，为了方便第二卡夹62与响筒4之间的相对移动，本方案还在响筒4侧壁设计有卡夹避让开口44，如图15至图17以及图26所示，卡夹避让开口44位于卡夹限位开口43的后端方向。
需要说明的是，复位弹性件作为保持释放环6和护针罩2处于初始轴向位置的保持件以及在注射完毕后使释放环6和护针罩2恢复至初始轴向位置的恢复件，复位弹性件可以为释放环6提供持续的向前端方向施加的弹力作用，其具体可采用螺旋弹簧、弹力绳或金属弹片等弹性零件，优选地，复位弹性件为复位弹簧8，如图31所示，复位弹簧8压缩布置于释放环6和壳体1之间。如图34所示，本方案中还在释放环6的后端设计有用于与复位弹簧8抵接的释放环后端凸缘61，复位弹簧8的前端抵接于释放环后端凸缘61，复位弹簧8的后端则抵接于后壳体12的后端内壁，复位弹簧8在初始组装状态时也可处于压缩状态。
上文中所介绍的针帽14、护针罩2、前壳体11和弹性垫块113这四个零件组成前壳体的保持组件，主要用于保持固定针筒9的位置；上文中所介绍的推杆3、响筒4、内管5、释放环6、推杆弹簧7、弹簧导杆71、复位弹簧8、后壳体12这八个零部件组成后壳体的驱动组件，主要用于实现驱动注射的功能。
需要说明的是，本发明自动注射器的各个零件可以由各种不同的材料制作而成(例如医疗器材中常用的树脂、金属等)，也可以具有不同的规格和结构。
下面，请参照图1至图3以及图32至图41，介绍一下本发明提供的自动注射器的完整使用过程。
图1至图3分别是在使用之前的自动注射器的整体外部结构示意图以及两个纵向截面示意图，此时，该自动注射器的针帽14还安装于壳体1的前端。前壳体11适于保持容纳药剂的针筒9，针筒9可以是预填充的注射筒，并且具有布置在针筒9前端的针头91，在其他实施例中，针筒9可以是适于可拆除地连接针头91的药剂筒。针头91朝前壳体11的前端开口布置，针头91可由针鞘92保护，在注射之前的初始组装状态时，护针罩2伸出于壳体1的前端并能够保护针头91和针鞘92。
如图32所示，在准备注射时，将针帽14向前端拔除掉，护针罩2的前端 则露出于壳体11之外，针头91仍被护针罩2遮蔽。然后，手持壳体1并使壳体1的前端对准身体需要注射的部位，将护针罩2对准需要注射的部位并用力按压，此时，护针罩2向壳体1内部收缩，并露出针头91，从而使针头91能够刺入需要注射的部位。当护针罩2被向后推进时，护针罩2的后端面会抵住释放环6的前端，护针罩2克服复位弹簧8的弹力并带动释放环6一同相对壳体1向后端移动并压缩复位弹簧8，直到释放环6的第二卡夹62抵接于内管5的内管避让槽孔54，如图33至图35所示。同时，护针罩2内壁设置的护针罩内圈凸起23会抵接于前壳体11内部的针筒夹爪112，以提供对针筒9前端肩部的辅助支撑。
在释放环6向壳体1后端方向移动的过程中，内管5的第一卡夹55脱离释放环6的内壁的限位，从而释放对推杆3的卡接限位，如图36至图37所示，推杆3在推杆弹簧7的作用下向针筒9的前端滑动，并通过活塞93将针筒9内的液体经针头91注射到身体内，从而实现自动注射。
在推杆3注射过程中，推杆3的外壁能够对响筒凸块41提供持续的支撑作用，从而保证响筒4与内管5的位置相对固定；而当推杆3滑动预设距离后，即，推杆3将针筒9内的预设量的液体注射完毕后，响筒凸块41脱离推杆3的外壁的支撑，从而使得响筒4能够在推杆弹簧7的作用下向壳体1的后端方向滑动。响筒4在滑动过程中或者在滑动一定距离后，可以通过发声、发光、摩擦、撞击振动等多种方式提示使用者注射完毕，本方案中采用响筒4与后壳体12的端板120内侧的环状凸起121的相互撞击发出声音的方式来提示注射完毕，如图38和图39所示。使用者只需将针头91从身体拔出即可完成整个注射过程。
另外，由于释放环6被向后推时压缩了复位弹簧8，所以一旦护针罩2的前端离开了注射部位，释放环6失去了向后端方向的推压力，释放环6便被复位弹簧8向前端方向推动，从而迫使护针罩2回到前壳体11的第一限位台阶111处，如图40所示。而当护针罩2回到初始轴向位置后，由于响筒4的轴向位置已经向壳体1后端方向移动了一段距离，因此，释放环6的第二卡夹62会卡入到响筒4的卡夹限位开口43中，从而使得响筒4受到卡夹限位开口43的轴向限位而无法再次向后移动，如图40和图41所示，这样就可以锁定护针罩2的轴向位置并避免针头91外露，即，避免该自动注射器被二次利用，从而保证了较高的使用安全性。
本发明方案具有以下有益效果：
1)本方案提供的自动注射器通过八个零部件即可实现预灌封针筒的自动注射功能，相对于现有技术中的自动注射器，本方案结构简单，零件数目少；
2)本方案通过按压方式即可实现自动注射的功能，机构动作原理简单、可靠度高；
3)产品易于组装，降低人工组装成本，提高产品良率。
对所公开的实施例的上述说明，使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。

Claims (20)

  1. 一种自动注射器，其特征在于，包括：壳体(1)、护针罩(2)、推杆(3)、响筒(4)、内管(5)、释放环(6)、驱动弹性件、复位弹性件；
    所述壳体(1)内设有用于固定针筒(9)的针筒固定结构，所述壳体(1)的前端设有供针头(91)伸出的开口；
    所述壳体(1)内侧由后端至前端方向依次滑动设置有所述释放环(6)和所述护针罩(2)，所述护针罩(2)能够伸出于所述壳体(1)的前端且能够相对所述壳体(1)向后端滑动并推动所述释放环(6)，所述复位弹性件作用于所述释放环(6)并驱使所述释放环(6)推动所述护针罩(2)向所述壳体(1)的前端滑动；所述壳体(1)设置有用于限定所述护针罩(2)相对所述壳体(1)向前的滑动距离的护针罩限位结构；
    所述推杆(3)沿轴向滑动设置于所述壳体(1)内部，且所述推杆(3)的前端用于推动所述针筒(9)内的活塞(93)，所述驱动弹性件作用于所述推杆(3)并驱使所述推杆(3)向所述针筒(9)的前端滑动，所述推杆(3)的外周设有推杆限位结构；
    所述响筒(4)沿轴向滑动套设于所述推杆(3)的外周，所述驱动弹性件作用于所述响筒(4)并驱使所述响筒(4)向所述壳体(1)的后端滑动，所述响筒(4)设有推杆限位配合结构，所述响筒(4)与所述内管(5)之间设有响筒限位结构；
    所述内管(5)固定于所述壳体(1)内部并且套设于所述响筒(4)的外周，所述释放环(6)滑动套设于所述内管(5)的外周，所述内管(5)设有能够沿径向弹性移动的第一卡夹(55)，所述第一卡夹(55)在自身弹力作用下沿径向向外偏移；
    所述第一卡夹(55)能够在所述释放环(6)的内壁的限位作用下沿径向向内偏移并通过所述推杆限位配合结构与所述推杆限位结构相互卡接限位，所述响筒限位结构能够在所述推杆(3)的外壁的支撑作用下限制所述响筒(4)与所述内管(5)的相对滑动，所述推杆(3)能够在向前端滑动预设距离后脱离对所述响筒限位结构的支撑。
  2. 根据权利要求1所述的自动注射器，其特征在于，所述壳体(1)的后 端设有用于与所述响筒(4)撞击限位的信号结构。
  3. 根据权利要求2所述的自动注射器，其特征在于，所述信号结构为固定于所述壳体(1)的后端的端板(120)。
  4. 根据权利要求1所述的自动注射器，其特征在于，还包括针帽(14)，所述针帽(14)可拆卸地连接于所述护针罩(2)的前端。
  5. 根据权利要求4所述的自动注射器，其特征在于，所述针帽(14)的后端设有用于与针鞘(92)的后端相互卡接的勾爪(143)，所述勾爪(143)能够对所述针鞘(92)施加向前端方向的拉力作用。
  6. 根据权利要求4所述的自动注射器，其特征在于，所述针帽(14)的内圈与所述护针罩(2)的周向之间设有防脱凹凸配合结构。
  7. 根据权利要求4所述的自动注射器，其特征在于，所述壳体(1)与所述针帽(14)之间设有用于限制所述针帽(14)相对所述壳体(1)向后端方向移动的针帽限位结构(144)。
  8. 根据权利要求1所述的自动注射器，其特征在于，所述针筒固定结构为固定于所述壳体(1)内侧的针筒固定筒(110)，所述针筒固定筒(110)的前端设有用于与所述针筒(9)的前端肩部限位配合的针筒夹爪(112)。
  9. 根据权利要求8所述的自动注射器，其特征在于，所述针筒固定筒(110)的后端设有用于与所述针筒(9)的后端法兰(94)限位配合的支撑体(114)，所述支撑体(114)与所述针筒(9)的所述后端法兰(94)的前端面之间设有弹性垫块(113)。
  10. 根据权利要求1所述的自动注射器，其特征在于，所述内管(5)的前端抵接于所述针筒(9)的后端法兰(94)的后端面，所述内管(5)的后端抵接于所述壳体(1)的后端。
  11. 根据权利要求10所述的自动注射器，其特征在于，所述壳体(1)的后端设有与所述内管(5)的后端同轴配合的环状凸起(121)，所述壳体(1)的侧壁与所述内管(5)之间设有用于防止所述内管(5)旋转的旋转限位结构。
  12. 根据权利要求1所述的自动注射器，其特征在于，所述推杆限位配合结构为开设于所述响筒(4)的侧壁上的响筒避让缺口(42)，所述响筒避让缺口(42)沿所述响筒(4)的轴向延伸布置。
  13. 根据权利要求1所述的自动注射器，其特征在于，所述响筒限位结构包括设置于所述响筒(4)外壁的响筒凸块(41)以及开设于所述内管(5)上 的用于与所述响筒凸块(41)限位卡接的内管卡孔(53)。
  14. 根据权利要求1所述的自动注射器，其特征在于，所述内管(5)设有沿轴向延伸的内管避让槽孔(54)，所述释放环(6)设有与所述内管避让槽孔(54)滑动配合的第二卡夹(62)，且所述第二卡夹(62)能够与所述响筒(4)相互作用，所述响筒(4)的外侧设有用于限制所述第二卡夹(62)向所述壳体(1)的后端方向移动的卡夹限位结构。
  15. 根据权利要求1所述的自动注射器，其特征在于，所述推杆(3)为中空的杆状结构，所述驱动弹性件为设置于所述推杆(3)内部的推杆弹簧(7)，所述推杆弹簧(7)压缩布置于所述推杆(3)的前端和所述响筒(4)的后端之间。
  16. 根据权利要求15所述的自动注射器，其特征在于，所述推杆(3)的内部滑动设置有弹簧导杆(71)，所述推杆弹簧(7)套设于所述弹簧导杆(71)的外周。
  17. 根据权利要求1所述的自动注射器，其特征在于，所述复位弹性件为复位弹簧(8)，所述复位弹簧(8)压缩布置于所述释放环(6)和所述壳体(1)之间。
  18. 根据权利要求1所述的自动注射器，其特征在于，所述壳体(1)包括前壳体(11)和后壳体(12)，所述前壳体(11)连接于所述后壳体(12)的前端。
  19. 根据权利要求1所述的自动注射器，其特征在于，所述壳体(1)和所述护针罩(2)均设有沿轴向延伸的观察窗口(13)。
  20. 根据权利要求1所述的自动注射器，其特征在于，所述护针罩限位结构包括设置于所述壳体(1)内壁的第一限位台阶(111)和设置于所述护针罩(2)外壁的第二限位台阶(22)。
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EP4230241C0 (en) 2025-03-12
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