WO2023179178A1 - 一种带有前置护罩的预灌封注射器 - Google Patents

一种带有前置护罩的预灌封注射器 Download PDF

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Publication number
WO2023179178A1
WO2023179178A1 PCT/CN2023/070630 CN2023070630W WO2023179178A1 WO 2023179178 A1 WO2023179178 A1 WO 2023179178A1 CN 2023070630 W CN2023070630 W CN 2023070630W WO 2023179178 A1 WO2023179178 A1 WO 2023179178A1
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WIPO (PCT)
Prior art keywords
needle
protective cover
unit
syringe
outer diameter
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/CN2023/070630
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English (en)
French (fr)
Inventor
郭融
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.)
Shanghai Xinyao Paike Medical Technology Co Ltd
Original Assignee
Shanghai Xinyao Paike Medical Technology Co Ltd
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Application filed by Shanghai Xinyao Paike Medical Technology Co Ltd filed Critical Shanghai Xinyao Paike Medical Technology Co Ltd
Publication of WO2023179178A1 publication Critical patent/WO2023179178A1/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
    • 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
    • A61M5/31—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
    • A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • 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
    • A61M5/31—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
    • 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

Definitions

  • the invention belongs to the technical field of syringes, and in particular relates to a prefilled syringe with a front shield.
  • a syringe is a medical device used to inject liquid medicine into the human body or for cleaning purposes. When used for human injection, it is often equipped with a needle. Because the syringe needs to be filled with medicine before injection. The traditional way of filling medicine is to insert the needle tip into the medicine bottle to draw out the medicine liquid. However, this is time-consuming, laborious and wastes medicine. Therefore, prefilled syringes are currently on the market.
  • the sealing equipment fills the syringe with medicine in advance, so that when the syringe is actually used, the medicine is already inside, saving time and effort.
  • the syringe needs to be discarded after use.
  • the exposed needle carries the risk of injuring people, and the blood and bacteria remaining in the needle can cause infection in the process of injuring people. Therefore, how to ensure that the needle of the syringe is not exposed during the discarding process becomes a syringe preparation process.
  • a protective cover is generally used to cover the needle when the syringe is discarded.
  • the Chinese invention patent with the publication number CN1913933B and the publication date of 2012-12-26 discloses a medical device.
  • a guard system and a syringe connected to the guard system including a syringe bracket and a shield slidably connected to the bracket.
  • the spring presses the guard from the retracted position to the extended position.
  • the limiting member is provided on the bracket and the protective cover and is used to keep the protective cover in the retracted position.
  • the syringe is slidably connected to the bracket and extends within the protective cover. Axial movement of the syringe relative to the carriage causes separation of the stop members, allowing the spring to move the shield to the extended position.
  • the locking part is provided on the bracket and is used to keep the protective cover in the extended position, reducing the risk of needle stick injuries.
  • the protective cover part of this invention uses a spring to move, and the spring surrounds the syringe, which affects the user's view of the medical liquid in the syringe, and further affects the user's judgment of the state of the medical liquid inside the syringe.
  • the filling device needs to fix the syringe when adding medicine to the prefilled syringe.
  • This design of the protective cover on the syringe affects the fixing process of the filling device to a certain extent. , causing the dosing process to be unstable.
  • the object of the present invention is to provide a prefilled syringe with a front shield.
  • the invention uses a needle, a syringe barrel, a needle cover, a needle seat unit, and a protective cover unit to cover the needle without covering the syringe. Surface technical effects.
  • a prefilled syringe with a front shield including a needle, a syringe barrel, and a needle cover, a needle seat unit, and a protective cover unit, wherein:
  • the needle, syringe barrel, needle cover, needle seat unit, and protective cover unit are coaxially arranged;
  • the protective cover unit includes a lower stopper and an upper stopper
  • the lower stopper is close to the distal side of the protective cover unit, and the upper stopper is close to the proximal side of the protective cover unit;
  • the minimum inner diameter of the lower stopper and the upper stopper is both smaller than the maximum outer diameter of the syringe barrel, and the minimum inner diameter of the upper stopper is also smaller than the maximum outer diameter of the needle seat unit;
  • the inner diameter of the upper stopper can be expanded to make its minimum inner diameter larger than the maximum outer diameter of the syringe barrel.
  • the protective cover unit further includes a stop piece, wherein:
  • the lower stopper is located between the lower stopper and the upper stopper;
  • the minimum inner diameter of the stop piece is smaller than the maximum outer diameter of the needle seat unit
  • the inner diameter of the stop member can be expanded to make its minimum inner diameter larger than the maximum outer diameter of the needle seat unit.
  • the protective cover unit includes a protective cover main body and a stop hook, wherein:
  • the distal end of the stop hook is connected to the proximal end of the protective cover body
  • the proximal end of the stop hook is in contact with the proximal side of the maximum outer diameter of the needle seat unit.
  • the protective cover unit further includes a limiting ring, wherein:
  • the limiting ring is provided at the distal end of the protective cover body
  • the proximal end of the limiting ring is fitted to the distal side of the maximum outer diameter of the syringe barrel.
  • stop hook includes an elastic member and a snapping member; wherein:
  • the distal end of the elastic member is disposed on the proximal end of the protective cover body;
  • the engaging member is provided on the proximal end of the elastic member
  • the distal end of the engaging member is in contact with the proximal side of the maximum outer diameter of the needle seat unit.
  • the prefilled syringe with a front shield also includes a retraction end, wherein:
  • the retraction end is provided at the distal end of the syringe barrel and is used to install the needle seat unit;
  • the distal end of the retracting end has a slope, so that when the main body of the protective cover is opened, the engaging member passes over the retracting end.
  • stop hook also includes a proximal bevel, wherein;
  • the proximal inclined surface is provided at the proximal end of the engaging member, allowing the engaging member to pass over the retracted end when the main body of the protective cover is opened.
  • the needle seat unit includes a needle mounting part and a ridge part, wherein:
  • the needle is mounted on the proximal end of the needle mounting member
  • the rib member is installed on the distal end of the needle mounting member
  • the distal end of the convex rib member is in contact with the proximal end of the stop member;
  • the proximal end of the rib member is in contact with the distal end of the engaging member.
  • a further preferred technical solution is that the maximum outer diameter of the convex rib member is smaller than the maximum outer diameter of the retraction end.
  • the protective cover unit further includes a demoulding groove, wherein:
  • the demoulding groove is provided on the limiting ring
  • the demoulding groove provides the space for retraction when the inner diameter of the limiting ring is expanded.
  • the protective cover unit further includes a cantilever member, wherein:
  • the distal end of the cantilever member is disposed on the proximal end of the protective cover body;
  • the proximal end of the cantilever member is in contact with the distal end of the rib member.
  • the needle seat unit further includes a concave groove; wherein:
  • the recessed groove is provided on the needle mounting piece.
  • the protective cover unit further includes a fingertip groove; wherein:
  • the fingertip groove is provided at the distal end of the protective cover body
  • the fingertip groove is used for pinching and exerting force by the fingertips when opening the main body of the protective cover.
  • the protective cover unit further includes force-guiding protruding strips; wherein:
  • the force-guiding protruding strip is arranged on the inner bottom surface of the fingertip groove
  • the force-guiding protruding strips are used to increase the frictional resistance when pinched by the fingertips.
  • the range of movement of the protective cover is near the needle of the syringe, which does not affect the operator's view of the medicinal liquid through the syringe, nor does it affect the light inspection.
  • the axial position of the protective cover can be adjusted by pushing and pulling to expose the needle to complete the injection, and to cover the needle and discard it after the injection is completed to prevent the needle from injuring others.
  • the limiting ring is designed to snap between the ridge and the retracted end when the protective cover is opened, stably fixing the position of the protective cover.
  • a demoulding groove is designed on the limit ring. On the one hand, it facilitates the separation of the limit ring from the grinding tool during production. On the other hand, it gives the limit ring a larger expansion space, making it easier to cross the convex edge piece on the convex edge. between the piece and the retracting end.
  • Figure 1 is an exploded view of the overall structure of the syringe of the present invention.
  • Figure 2 is a schematic structural diagram of the protective cover unit in the present invention when it is opened.
  • Figure 3 is a schematic structural diagram of the protective cover unit in the present invention when it is closed.
  • Figure 4 is a cross-sectional view taken along line AA in Figure 2 .
  • Figure 5 is a schematic structural diagram of the protective cover unit in the present invention.
  • each number the components represented by each number are as follows: needle seat unit 1, protective cover unit 2, needle cover 3, retraction tip 4, syringe barrel 5, needle 6, needle mounting piece 101, ridge piece 102, recess Groove 103, protective cover body 201, stop hook 202, limit ring 203, demoulding groove 204, cantilever member 205, fingertip groove 206, force guide protruding strip 207, elastic member 202a, engaging member 202b, near End bevel 202c.
  • Distal end refers to the end of the syringe facing the needle.
  • Proximal end refers to the end of the syringe away from the needle.
  • Axis refers to the line connecting the centroids of all cross-sections of a component with a symmetrical cross-section.
  • Open refers to the ability to expose the needle or needle cover during operation.
  • Socketing refers to the act of installing component one on the outer surface of component two when the inner diameter of component one is larger than the outer diameter of component two.
  • Pushing up means that component one exerts force on component two, causing component two to move in the direction opposite to the position of component one.
  • a prefilled syringe with a front shield includes a needle 6, a syringe barrel 5, and a needle cover 3, and also includes a needle seat unit 1 and a protective cover unit. 2, among which:
  • the needle 6, syringe barrel 5, needle cover 3, needle seat unit 1, and protective cover unit 2 are coaxially arranged;
  • the protective cover unit 2 includes a lower stopper and an upper stopper;
  • the lower stopper is close to the distal side of the protective cover unit 2, and the upper stopper is close to the proximal side of the protective cover unit 2;
  • the minimum inner diameter of the lower stopper and the upper stopper is both smaller than the maximum outer diameter of the syringe barrel 5, and the minimum inner diameter of the upper stopper is also smaller than the maximum outer diameter of the needle seat unit 1;
  • the inner diameter of the upper stopper can be expanded to make its minimum inner diameter larger than the maximum outer diameter of the syringe barrel 5 .
  • the "front” means that the protective cover unit 2 is located at the distal end of the entire syringe without covering the syringe barrel 5 at the proximal end of the entire syringe.
  • the needle 6 and the syringe barrel 5 constitute the main part of the syringe.
  • the needle seat unit 1 is arranged at the distal end of the syringe barrel 5 and sleeves the needle 6 through the hole opened along its axis. In this way, the syringe barrel 5 is The medicinal liquid can pass through the hole in the needle seat unit 1 and flow out of the needle 6 .
  • a push rod is installed at the proximal opening of the syringe to complete the overall assembly of the syringe.
  • the needle sleeve 3 is connected to the needle seat unit 1 and is The needle 6 is covered and sealed to prevent bacteria from entering and avoid the risk of leakage of the medicinal liquid.
  • the protective cover unit 2 is installed on the needle seat unit 1.
  • the upper stopper is engaged with the needle seat unit 1.
  • the upper stopper can be subjected to a radial force, thereby radially expanding to Its minimum inner diameter is larger than the maximum outer diameter of the syringe barrel 5 , so that the protective cover unit 2 can move axially to the outer ring surface of the syringe barrel 5 .
  • the protective cover unit 2 moves toward the proximal axial direction to the closed state, the lower stopper engages with the maximum outer diameter of the needle seat unit 1, and at this time, the protective cover unit 2 stops. Move to avoid blocking the syringe barrel 5, so that the range of movement of the protective cover unit 2 is limited to the vicinity of the needle 6, and does not affect the inspector's line of sight during the light inspection.
  • the protective cover unit 2 is in the position of covering the needle seat unit 1 and the syringe barrel 5 is not blocked. This has the advantage that it does not affect filling. The lighting inspection process after filling, and when the nurse receives the filled product, it does not affect the nurse's visual inspection of the medicine and the check of the scale.
  • the protective cover unit 2 also includes a stop piece, wherein:
  • the lower stopper is located between the lower stopper and the upper stopper;
  • the minimum inner diameter of the stop member is smaller than the maximum outer diameter of the needle seat unit 1;
  • the inner diameter of the stop member can be expanded to make its minimum inner diameter larger than the maximum outer diameter of the needle seat unit 1 .
  • the stop bit and the upper stop bit are respectively in contact with each other.
  • the distal end and the proximal end at the maximum outer diameter of the needle seat unit 1 form a clamping effect on the needle base unit 1, thereby achieving a fixing effect on the protective cover unit 2.
  • the protective cover unit 2 includes a protective cover body 201 and a stop hook 202, wherein:
  • the distal end of the stop hook 202 is connected to the proximal end of the protective cover body 201;
  • the proximal end of the stop hook 202 is in contact with the proximal side of the maximum outer diameter of the needle seat unit 1 .
  • the protective cover body 201 is the main component covering the needle 6 and can switch the covering state between the needle 6, the needle seat unit 1 and the syringe barrel 5 along the axial direction.
  • the stop hook 202 is a form of the upper stop member.
  • the proximal end of the stop hook 202 has a radially downwardly extending engaging member for connecting with the maximum outer diameter of the needle hub unit 1
  • the proximal side of the stop hook 202 also includes an elastic member connected to the proximal end of the proximal end of the protective cover body 201 and a distal end connected to the proximal end of the protective cover body 201.
  • step S1 the protective cover is pushed
  • the elastic member receives the pushing force from the outer ring surface of the syringe barrel 5 and expands radially, thereby driving the engaging member to expand radially and fit on the surface of the syringe barrel 5 .
  • the protective cover unit 2 also includes a limiting ring 203, wherein:
  • the limiting ring 203 is provided at the distal end of the protective cover body 201;
  • the proximal end of the limiting ring 203 is in contact with the distal side of the maximum outer diameter of the syringe barrel 5 .
  • the limit ring 203 is a form of the lower stop member, which is integrally formed with the main body 201 of the protective cover. It will not pinch your hand during the pushing process, and it fits in an annular manner. It is more secure when it is pressed against the distal side of the maximum outer diameter of the syringe barrel 5, and will not cross the distal side of the maximum outer diameter of the syringe barrel 5 due to deformation, causing the protective cover main body 201 to continue along the The axis moves proximally, thereby blocking the syringe barrel 5 .
  • the stop hook 202 includes an elastic member 202a and a locking member 202b; wherein:
  • the distal end of the elastic member 202a is provided on the proximal end of the protective cover body 201;
  • the engaging member 202b is provided on the proximal end of the elastic member 202a;
  • the distal end of the engaging member 202b is in contact with the proximal side of the maximum outer diameter of the needle seat unit 1 .
  • the front shield for prefilled syringes also includes a retraction end 4, wherein:
  • the retraction end 4 is provided at the distal end of the syringe barrel 5 and is used to install the needle seat unit 1;
  • the distal end of the retracting end 4 has an inclined surface, so that the engaging member 202b passes over the retracting end 4 when the protective cover body 201 is opened.
  • the inclined surface forms a groove with the proximal side of the maximum outer diameter of the needle seat unit 1.
  • the groove can be used in the initial position of the protective cover body 201 in S1 and in the protective cover main body 201 in S3.
  • the engaging member 202b is engaged, and at the same time cooperates with the stop member to push up the distal end surface at the maximum outer diameter of the needle seat unit 1, so that the protective cover main body 201 is covering the needle.
  • the stop hook 202 also includes a proximal bevel 202c, wherein;
  • the proximal inclined surface 202c is provided at the proximal end of the engaging member 202b, so that the engaging member 202b passes over the retracting end 4 when the protective cover body 201 is opened.
  • the slope of the proximal slope 202c is the same as the slope of the slope.
  • the proximal slope 202c is in contact with the slope.
  • the proximal inclined surface 202c can easily cross the inclined surface, thereby preventing the latch 202b from getting stuck in the groove.
  • the needle seat unit 1 includes a needle mounting part 101 and a ridge part 102, wherein:
  • the needle 6 is installed on the proximal end of the needle mounting member 101;
  • the rib member 102 is installed on the distal end of the needle mounting member 101;
  • the distal end of the rib member 102 is engaged with the proximal end of the stop member
  • the proximal end of the rib member 102 is in contact with the distal end of the engaging member 202b.
  • the needle mounting member 101 contains the hole, the hole is connected with the syringe barrel 5, and the needle 6 is installed in the hole, so that in S3, the syringe barrel 5
  • the pre-filled medicinal liquid in the injection mold can flow out from the needle 6 along the hole to complete the injection.
  • the convex rib member 102 is an expression of the maximum outer diameter of the needle seat unit 1 , and the proximal end surface of the convex rib member 102 and the distal end surface of the retracting tip 4 form a The groove, the rib member 102 is an annular structure, so that at the initial position of the protective cover main body 201 in S1 and the final position of the protective cover main body 201 in S3, no matter how the protective cover main body 201 rotates, the The distal end surface of the engaging member 202b is always in contact with the proximal end surface of the rib member 102
  • the maximum outer diameter of the rib member 102 is smaller than the maximum outer diameter of the retraction end 4 . in:
  • the limiting ring 203 can enlarge its inner diameter so as to pass over the rib member 102 and fit on the distal end of the retracting head 4 .
  • the limiting ring 203 has elasticity within a certain range, but the elasticity is not enough to allow the minimum inner diameter of the limiting ring 203 to expand larger than the maximum outer diameter of the retracting end 4 , that is, the limiting ring 203 has elasticity within a certain range.
  • the limit ring 203 cannot cross the retracted end 4 and enter the outer ring surface of the protective cover body 201. Therefore, during the S1 process, according to the maximum inner diameter of the limit ring 203, its design scheme There are three types:
  • the minimum inner diameter of the limiting ring 203 is smaller than the maximum outer diameter of the rib member 102 , and the elasticity of the limiting ring 203 is not enough to allow the minimum inner diameter of the limiting ring 203 to expand to greater than
  • the maximum outer diameter of the rib member 102 is such that when the shield body 201 moves to the final position during the S1 process, the proximal end face of the limiting ring 203 is in contact with the distal end face of the rib member 102 .
  • the minimum inner diameter of the limiting ring 203 is smaller than the maximum outer diameter of the rib member 102, but the elasticity of the limiting ring 203 can make the minimum inner diameter of the limiting ring 203 expand to be larger than the maximum outer diameter of the limiting ring 203.
  • the maximum outer diameter of the rib member 102 is set so that when the shield body 201 moves to the final position during the S1 process, the limiting ring 203 will cross over the rib member 102 and snap into place on the rib member. 102 and the retraction end 4 in the groove.
  • the minimum inner diameter of the limiting ring 203 is greater than the maximum outer diameter of the rib member 102 , so that when the shield body 201 moves to the final position during the S1 process, the limiting ring 203 The proximal end face is in contact with the distal end face of the retracting tip 4 .
  • the fixing effect is better when the protective cover body 201 moves to the final position during the S1 process, which is the preferred design of the limiting ring 203.
  • the protective cover unit 2 also includes a demoulding groove 204, wherein:
  • the demoulding groove 204 is provided on the limiting ring 203;
  • the demoulding groove 204 gives the limiting ring 203 a retraction space when its inner diameter expands.
  • the limiting ring 203 needs to be prepared by a mold during the product manufacturing process.
  • the limiting ring 203 has a convex structure inside the ring for pushing up the rib member 102, as
  • the mold cannot actually make the convex structure.
  • forced demoulding can only be used.
  • the risk brought by this is that the product shell of the limit ring 203 may break.
  • the demoulding groove 204 is provided on the limit ring 203, it will give the limit ring 203 a retreat space when demoulding, increase the toughness of the shell structure, reduce and prevent the product from breaking during the forced demoulding process. risk.
  • the demoulding groove 204 gives the limiting ring 203 a larger retreat space, that is to say, the limiting ring 203 is increased.
  • the elasticity makes it easier to pass over the ridge member 102 and snap into the groove.
  • the protective cover unit 2 also includes a cantilever member 205, wherein:
  • the distal end of the cantilever member 205 is provided on the proximal end of the protective cover body 201;
  • the proximal end of the cantilever member 205 is engaged with the distal end of the rib member 102 .
  • the cantilever member 205 is a form of the stop member, and its distal end face is a vertical plane, which can push up the proximal end face of the ridge member 102, so that when lifting In this state, the protective cover body 201 will not move axially toward the proximal direction.
  • the needle base unit 1 also includes a recessed groove 103; wherein:
  • the recessed groove 103 is provided on the needle mounting member 101 .
  • the recessed groove 103 is axially opened on the needle mounting member 101 so that the needle mounting member 101 forms a cross-shaped structure.
  • This structure can be used when the mold temperature is too high or too low. It avoids the problem of injection shrinkage, and can achieve material reduction and reduce the overall weight of the syringe.
  • the protective cover unit 2 also includes a fingertip groove 206; wherein:
  • the fingertip groove 206 is provided at the distal end of the protective cover body 201;
  • the fingertip grooves 206 are used for pinching and exerting force with the fingertips when opening the protective cover body 201 .
  • the protective cover body 201 is relatively smooth and difficult to exert force, and once the finger slips, there is a risk of being stuck on the needle 6, so the fingertip groove 206 is provided. The user's fingers can rest against the inner surface of the fingertip groove 206 to facilitate exerting force.
  • the protective cover unit 2 also includes force-guiding protruding strips 207; wherein:
  • the force-guiding protruding strip 207 is provided on the inner bottom surface of the fingertip groove 206;
  • the force-guiding protruding strips 207 are used to increase the frictional resistance when pinched by the fingertips.
  • the inner bottom surface of the fingertip groove 206 is still a smooth surface.
  • a plurality of the force-guiding protruding strips 207 are provided on the inner bottom surface of the fingertip groove 206. Generally, there are three. When the user's fingers are pinching, they can fit more firmly with the inner bottom surface of the fingertip groove 206 without causing misalignment.
  • An assembly of a prefilled syringe with a front shield including an injection piston, and an injection push rod installed on the injection piston through plugging.
  • the injection piston is used to push out the medical liquid in the syringe barrel 5 to complete the injection process
  • the injection push rod is a device that pushes the injection piston
  • An assembly method of a prefilled syringe assembly with a front shield including the following steps:
  • the needle cover 3 when the needle cover 3 pushes up the stop hook 202, it is installed at a prescribed position. While installing the protective cover unit 2 on the needle mounting member 101, a grab is also used. The holding device aligns the needle sleeve 3 with the needle 6 and pushes the needle sleeve 3 to be installed on the needle 6 to complete the sealing.
  • a drug filling method for an assembly of a pre-filled syringe with a front shield including the following steps:
  • the purpose of making the liquid level of the liquid medicine perpendicular to the inner surface of the syringe barrel 5 is so that when the injection piston is installed in the next step, there will be no gap between the liquid level and the medicine liquid level. There is air.
  • the injection piston is installed in the sleeve in a compressed state, which means that there is a gap between the sleeve and the syringe barrel 5 for discharging gas.
  • the injection piston is installed in the syringe barrel. 5, the diameter is expanded and pressed against the inner surface of the syringe barrel 5, achieving the effect of "drug potting".

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Abstract

一种带有前置护罩的预灌封注射器。该预灌封注射器通过针（6），注射器筒（5），以及针套（3），针座单元（1），以及防护罩单元（2）起到了包覆针头的同时不遮盖针筒表面的技术效果。该预灌封注射器具有以下优点：第一，防护罩的活动范围在注射器的针（6）附近，不影响操作者通过针筒观察药液的视线，不影响灯检；第二，防护罩通过推拉动作即可调整轴向位置，用于露出针头完成注射，以及注射完毕后包覆针头丢弃，避免针刺伤他人；第三，设计限位环（203）在打开防护罩时，可以卡合在凸棱件（102）与回缩端头（4）之间，稳定固定防护罩的位置；第四，在限位环（203）上设计了脱模槽（204），利于限位环（203）制作时与磨具脱离同时给予限位环（203）更大的扩张空间，便于越过凸棱件（102）并与回缩端头（4）卡合。

Description

一种带有前置护罩的预灌封注射器 技术领域
本发明属于注射器技术领域，尤其涉及一种带有前置护罩的预灌封注射器。
 背景技术
注射器是一种用于将液体药物注入人体，或者用于清洗用途的医用器材，当用于人体注射时，往往配有针头。因为注射前需要对注射器中填充药物，传统填充药物的方式是将针尖插入药瓶中抽取药液，但是这样做费时费力，且浪费药品，所以目前市场中出现了预灌封式注射器，通过灌封设备提前对注射器中填充药品，这样在注射器实际使用时，内部已经装有药品，使用起来省时省力。
然而注射器使用完毕后需要丢弃，暴露在外的针头存在伤人的风险，并且针头残留的血液、细菌会在伤人的过程中造成感染，于是如何保证注射器在丢弃过程中针头不外露成为注射器制备过程急需解决的问题，现有技术中，一般使用防护罩在注射器丢弃时对针头进行包覆，例如公开号为CN1913933B，公开日为2012-12-26的中国发明专利公开了一种医疗装置，其包括防护系统和连接到所述防护系统的注射器，该防护系统包括注射器托架和可滑动地连接到该托架的防护罩。弹簧将防护罩从缩回位置压迫到伸出位置。限位构件设在托架和防护罩上，用于将防护罩保持在缩回位置。注射器可滑动地连接到托架，并在防护罩内延伸。注射器相对于托架的轴向移动造成限位构件的分离，从而允许弹簧将防护罩移动到伸出位置。卡止部设在托架上，用于将防护罩保持在延伸位置，降低了针刺伤害的风险。
然而该发明的保护罩部分利用了弹簧进行移动，而所述弹簧环绕在针筒上，影响使用者观察注射器内药液的视线，进而影响使用者对注射器内部药液状态的判断。
另一方面，灌封装置在对预灌装注射器进行加药过程时，需要对针筒进行固定，这种出现在针筒上的防护罩设计，在一定程度上影响了灌封装置的固定过程，导致加药过程不稳定。
 技术问题
所以综上所述，目前急需一种用于包覆针头，并且不遮盖针筒表面的注射器防护罩装置。
 技术解决方案
本发明目的是提供一种带有前置护罩的预灌封注射器，本发明通过针，注射器筒，以及针套，针座单元，以及防护罩单元起到了包覆针头的同时不遮盖针筒表面的技术效果。
本发明解决上述问题采用的技术方案是：一种带有前置护罩的预灌封注射器，包括针，注射器筒，以及针套，还包括针座单元，以及防护罩单元，其中：
所述针，注射器筒，针套，针座单元，以及防护罩单元同轴线设置；
所述防护罩单元包括下止位件和上止位件；
所述下止位件靠近所述防护罩单元远端侧，所述上止位件靠近所述防护罩单元近端侧；
所述下止位件和上止位件的最小内径均小于所述注射器筒的最大外径，并且所述上止位件的最小内径还小于所述针座单元的最大外径；
在所述防护罩单元打开时，所述上止位件内径可扩张，使其最小内径大于所述注射器筒的最大外径。
进一步优选的技术方案在于：所述防护罩单元还包括中止位件，其中：
所述下止位件位于所述下止位件和上止位件中间；
所述中止位件的最小内径小于所述针座单元的最大外径；
在防护罩单元打开时，所述中止位件内径可扩张，使其最小内径大于所述针座单元的最大外径处。
进一步优选的技术方案在于：所述防护罩单元包括防护罩主体，以及止位钩，其中：
所述止位钩远端连接所述防护罩主体近端；
所述止位钩的近端与所述针座单元最大外径处近端一侧贴合。
进一步优选的技术方案在于：所述防护罩单元还包括限位环，其中：
所述限位环设置在所述防护罩主体远端；
所述限位环的近端与所述注射器筒最大外径处远端一侧贴合。
进一步优选的技术方案在于：所述止位钩包括弹性件，以及卡合件；其中：
所述弹性件远端设置在所述防护罩主体近端上；
所述卡合件设置在所述弹性件近端上；
所述卡合件远端与所述针座单元的最大外径处近端一侧贴合。
进一步优选的技术方案在于：所述一种带有前置护罩的预灌封注射器还包括回缩端头，其中：
所述回缩端头设置在所述注射器筒远端，且用于安装所述针座单元；
所述回缩端头远端具有斜面，在所述防护罩主体打开时，使得所述卡合件越过所述回缩端头。
进一步优选的技术方案在于：所述止位钩还包括近端斜面，其中；
所述近端斜面设置在所述卡合件近端，在所述防护罩主体打开时，使所述卡合件越过所述回缩端头。
进一步优选的技术方案在于：所述针座单元包括针安装件，以及凸棱件，其中：
所述针安装在所述针安装件近端上；
所述凸棱件安装在所述针安装件远端上；
所述凸棱件远端与所述中止位件近端贴合；
所述凸棱件近端与所述卡合件远端贴合。
进一步优选的技术方案在于：所述凸棱件最大外径小于所述回缩端头最大外径。
进一步优选的技术方案在于：所述防护罩单元还包括脱模槽，其中：
所述脱模槽设置在所述限位环上；
所述脱模槽给予所述限位环内径扩大时的回缩空间。
进一步优选的技术方案在于：所述防护罩单元还包括悬臂件，其中：
所述悬臂件远端设置在所述防护罩主体近端上；
在所述防护罩主体关闭时，所述悬臂件近端贴合在所述凸棱件远端上。
进一步优选的技术方案在于：所述针座单元还包括凹陷槽；其中：
所述凹陷槽设置在所述针安装件上。
进一步优选的技术方案在于：所述防护罩单元还包括指尖凹槽；其中：
所述指尖凹槽设置在所述防护罩主体远端；
所述指尖凹槽用于打开所述防护罩主体时供手指指肚捏持发力。
进一步优选的技术方案在于：所述防护罩单元还包括导力凸起条；其中：
所述导力凸起条设置在所述指尖凹槽内侧底面上；
所述导力凸起条用于提高手指指肚捏持时的摩擦阻力。
 有益效果
本发明具有以下优点：
第一，防护罩的活动范围在注射器的针附近，不影响操作者通过针筒观察药液的视线，不影响灯检。
第二，防护罩通过推拉动作即可调整轴向位置，用于露出针头完成注射，以及注射完毕后包覆针头丢弃，避免针刺伤他人。
第三，设计限位环在打开防护罩时，可以卡合在凸棱件与回缩端头之间，稳定固定防护罩的位置。
第四，在限位环上设计了脱模槽，一方面利于限位环制作时与磨具脱离，另一方面给予限位环更大的扩张空间，便于越过所述凸棱件在凸棱件与回缩端头之间卡合。
 附图说明
图1为本发明中注射器整体结构的爆炸图。
图2为本发明中防护罩单元打开时的结构示意图。
图3为本发明中防护罩单元关闭时的结构示意图。
图4为图2沿AA线切割的剖面图。
图5为本发明中防护罩单元的结构示意图。
附图中，各标号所代表的部件如下：针座单元1，防护罩单元2，针套3，回缩端头4，注射器筒5，针6，针安装件101，凸棱件102，凹陷槽103，防护罩主体201，止位钩202，限位环203，脱模槽204，悬臂件205，指尖凹槽206，导力凸起条207，弹性件202a，卡合件202b，近端斜面202c。
 本发明的实施方式
定义：
1.远端：指注射器朝向所述针一端。
2.近端：指注射器远离所述针一端。
3.轴线：指具有对称截面的部件，沿其所有横截面形心的连线。
4.打开：指在操作过程中能够暴露出针或者针套。
5.关闭：指在操作过程中能够包覆针或者针套。
6.套接：指部件一的内径大于部件二的外径时，将所述部件一安装在所述部件二外表面上的行为。
7.设置：指通过粘接、卡合、焊接、螺接、放置等一切用于将两个部件结合在一起的方式。
8.顶起：指部件一将力作用在部件二上，使得所述部件二朝向所述部件一位置相反的方向移动。
以下所述仅为本发明的较佳实施例，并非对本发明的范围进行限定。
实施例：如附图1-5所示，一种带有前置护罩的预灌封注射器，包括针6，注射器筒5，以及针套3，还包括针座单元1，以及防护罩单元2，其中：
所述针6，注射器筒5，针套3，针座单元1，以及防护罩单元2同轴线设置；
所述防护罩单元2包括下止位件和上止位件；
所述下止位件靠近所述防护罩单元2远端侧，所述上止位件靠近所述防护罩单元2近端侧；
所述下止位件和上止位件的最小内径均小于所述注射器筒5的最大外径，并且所述上止位件的最小内径还小于所述针座单元1的最大外径；
在所述防护罩单元2打开时，所述上止位件内径可扩张，使其最小内径大于所述注射器筒5的最大外径。
在本实施例中，所述“前置”指的是所述防护罩单元2处于所述注射器整体的远端，而不会遮盖到所述注射器整体近端的所述注射器筒5，所述针6以及注射器筒5构成注射器的主要部分，所述针座单元1设置在所述注射器筒5远端，并通过沿其轴线开设的孔道套接所述针6，这样所述注射器筒5中的药液便可以通过所述针座单元1中的所述孔道，从所述针6中流出。预灌装注射器的注射器筒5中灌装药液后，在其近端的开口处安装推杆即可完成注射器整体的组装，所述针套3套接在所述针座单元1上，并用于对所述针6进行包覆式密封，防止细菌进入，并且避免存在药液泄露的风险。
此外，所述针套3包覆在所述针6上时，所述防护罩单元2安装在所述针座单元1上，此时所述上止位件卡合在所述针座单元1的最大外径处与所述注射器筒5远端之间形成的卡合槽中，用力推动所述防护罩单元2，即可令所述上止位件受到径向力，从而径向扩张至其最小内径大于所述注射器筒5的最大外径，使得所述防护罩单元2可以轴向移动至所述注射器筒5的外环面上。
此外，在所述防护罩单元2朝近端轴向移动至关闭状态时，所述下止位件与所述针座单元1的最大外径处卡合，此时所述防护罩单元2停止移动，避免对注射器筒5进行遮挡，这样所述防护罩单元2的活动范围被限制在了所述针6附近，在灯检过程中不影响检查者的视线。
此外，药厂在拿到灌装前的产品时，所述防护罩单元2正处于包覆所述针座单元1的位置，所述注射器筒5未被遮挡，这样的优势在于，不影响灌装后的灯检工艺，并且护士在拿到灌装后的产品时，亦不影响护士对药物进行视觉检查，以及核对刻度。
预灌装注射器使用步骤如下：
S1.向轴向近端方向推动所述防护罩单元2，致使所述下止位件与所述针座单元1的最大外径处贴合为止；
S2.沿轴向拔出所述针套3，并完成注射过程；
S3.向轴向远端方向推动所述防护罩单元2，使得所述上止位件与所述针座单元1的最大外径处贴合为止，此时所述防护罩单元2对所述针6实现完全包覆。
所述防护罩单元2还包括中止位件，其中：
所述下止位件位于所述下止位件和上止位件中间；
所述中止位件的最小内径小于所述针座单元1的最大外径；
在防护罩单元2打开时，所述中止位件内径可扩张，使其最小内径大于所述针座单元1的最大外径处。
在本实施例中，所述S1中刚开始推动所述防护罩单元2，以及所述S3中所述防护罩单元2推动完毕时，所述中止位件与所述上止位件分别贴合所述针座单元1的最大外径处的远端以及近端，对其形成了夹持作用，实现了对所述防护罩单元2的固定效果。
此外，在所述S1中，为了能推动所述防护罩单元2，需要对所述中止位件施加外力，使其径向扩张，从而可以越过所述针座单元1的最大外径处，由此可知，在所述S3中，当所述中止位件越过所述针座单元1的最大外径处后，在未施加外力的情况下，所述防护罩单元2将保持在关闭位置，从而包覆所述针6避免露出伤人。
所述防护罩单元2包括防护罩主体201，以及止位钩202，其中：
所述止位钩202远端连接所述防护罩主体201近端；
所述止位钩202的近端与所述针座单元1最大外径处近端一侧贴合。
在本实施例中，所述防护罩主体201为包覆所述针6的主要部件，并可沿轴向在所述针6、针座单元1以及注射器筒5之间切换包覆状态。
所述止位钩202为所述上止位件的一种表现形式，所述止位钩202近端具有径向向下延伸的卡合件，用于与所述针座单元1最大外径处近端一侧贴合，并且所述止位钩202还包括近端连接所述卡合件，远端连接所述防护罩主体201近端的弹性件，在步骤S1中推动所述防护罩主体201时，所述弹性件受到来自所述注射器筒5外环面的顶起力而径向扩张，从而带动所述卡合件径向扩张从而贴合在所述注射器筒5表面。
此外，在所述S3中，回推所述防护罩主体201时，仅需在握持所述注射器筒5的情况下，用一根手指推动所述卡合件，从而推动所述防护罩主体201轴向移动并对所述针6完成包覆，当所述中止位件越过所述针座单元1最大外径处时，会听到“咔哒”一声，以表示卡合成功，所述针6完成包覆，可以丢弃，无需肉眼确认省时省力。
所述防护罩单元2还包括限位环203，其中：
所述限位环203设置在所述防护罩主体201远端；
所述限位环203的近端与所述注射器筒5最大外径处远端一侧贴合。
在本实施例中，所述限位环203为所述下止位件的一种表现形式，其与所述防护罩主体201一体成型，在推动过程中不会硌手，并且环形贴合方式使其顶在所述注射器筒5最大外径处远端一侧时更加牢固，不会因为形变而越过所述注射器筒5最大外径处远端一侧，导致所述防护罩主体201继续沿轴向近端移动，从而遮挡所述注射器筒5。
所述止位钩202包括弹性件202a，以及卡合件202b；其中：
所述弹性件202a远端设置在所述防护罩主体201近端上；
所述卡合件202b设置在所述弹性件202a近端上；
所述卡合件202b远端与所述针座单元1的最大外径处近端一侧贴合。
在本实施例所述S1中，当所述止位钩202受到径向力时，所述弹性件202a会径向向外扩张，从而带动所述卡合件202b解除对所述针座单元1的最大外径处近端一侧的贴合状态，所述弹性件202a在向外扩张后具有径向向内回缩的趋势，从而使得所述卡合件202b紧贴在所述注射器筒5的外环面上，产生一定摩擦力，这种摩擦力会使得所述防护罩主体201在不受轴向推动力的情况下位置相对于所述注射器筒5固定，从而方便操作者在所述S2中使用针6进行注射。
所述一种用于预灌封注射器的前置护罩还包括回缩端头4，其中：
所述回缩端头4设置在所述注射器筒5远端，且用于安装所述针座单元1；
所述回缩端头4远端具有斜面，在所述防护罩主体201打开时，使得所述卡合件202b越过所述回缩端头4。
在本实施例所述S1中，轴向推动所述防护罩主体201时，所述止位钩202受到的径向力来自于所述斜面顶起所述卡合件202b近端而产生的径向向外的分力，促使所述弹性件202a会径向向外扩张。
此外，所述斜面与所述针座单元1的最大外径处近端一侧形成凹槽，所述凹槽可以在所述S1中防护罩主体201初始位置以及所述S3中防护罩主体201最终位置处，卡合所述卡合件202b，同时配合所述中止位件顶起所述针座单元1的最大外径处远端端面，使得所述防护罩主体201在包覆所述针6位置处固定。
所述止位钩202还包括近端斜面202c，其中；
所述近端斜面202c设置在所述卡合件202b近端，在所述防护罩主体201打开时，使所述卡合件202b越过所述回缩端头4。
在本实施例中，所述近端斜面202c的斜率与所述斜面的斜率相同，在所述S1中，轴向推动所述防护罩主体201时，所述近端斜面202c与所述斜面贴在一起，在所述斜面固定的情况下，所述近端斜面202c可以轻易越过所述斜面，避免了所述卡合件202b卡死在所述凹槽中的情况发生。
所述针座单元1包括针安装件101，以及凸棱件102，其中：
所述针6安装在所述针安装件101近端上；
所述凸棱件102安装在所述针安装件101远端上；
所述凸棱件102远端与所述中止位件近端卡合；
所述凸棱件102近端与所述卡合件202b远端贴合。
在本实施例中，所述针安装件101中含有所述孔道，所述孔道与所述注射器筒5连通，所述针6安装在所述孔道中，这样在S3中，所述注射器筒5中的预灌装药液便可以顺着所述孔道从所述针6流出完成注射。
此外，所述凸棱件102为所述针座单元1的最大外径处的一种表现形式，所述凸棱件102的近端端面与所述回缩端头4的远端端面构成所述凹槽，所述凸棱件102为环形结构，这样使得在S1中防护罩主体201初始位置以及所述S3中防护罩主体201最终位置处，无论所述防护罩主体201如何转动，所述卡合件202b远端端面始终与所述凸棱件102近端端面贴合
所述凸棱件102最大外径小于所述回缩端头4最大外径。其中：
在所述防护罩主体201打开时，所述限位环203可扩大内径从而越过所述凸棱件102并贴合在所述回缩端头4远端上。
在本实施例中，所述限位环203具有一定范围内的弹性，但是该弹性不足以使得所述限位环203最小内径扩张至大于所述回缩端头4的最大外径，即所述限位环203无法越过所述回缩端头4进入到所述防护罩主体201外环面上，于是在所述S1过程中，根据所述限位环203的最大内径大小，其设计方案有三种：
第一种设计方案，所述限位环203的最小内径小于所述凸棱件102的最大外径，并且所述限位环203的弹性不足以使得所述限位环203最小内径扩张至大于所述凸棱件102的最大外径，这样在所述S1过程中防护罩主体201运动到最终位置时，所述限位环203近端端面与所述凸棱件102远端端面贴合。
第二种设计方案，所述限位环203的最小内径小于所述凸棱件102的最大外径，但所述限位环203的弹性可以使得所述限位环203最小内径扩张至大于所述凸棱件102的最大外径，这样在所述S1过程中防护罩主体201运动到最终位置时，所述限位环203会越过所述凸棱件102而卡合在所述凸棱件102与所述回缩端头4之间的所述凹槽中。
第三种设计方案，所述限位环203的最小内径大于所述凸棱件102的最大外径，这样在所述S1过程中防护罩主体201运动到最终位置时，所述限位环203近端端面与所述回缩端头4远端端面贴合。
其中所述第二种设计方案下，在所述S1过程中防护罩主体201运动到最终位置时固定效果更好，为所述限位环203的优选设计方案。
所述防护罩单元2还包括脱模槽204，其中：
所述脱模槽204设置在所述限位环203上；
所述脱模槽204给予所述限位环203内径扩大时的回缩空间。
在本实施例中，所述限位环203在产品制作过程中需要经过模具制备而成，所述限位环203在环内部具有用于顶起所述凸棱件102的凸起结构，为倒扣形状，但是模具无法真正做出来，为了形成该凸起结构，只能采取强制脱模的方法，这样带来的风险就是所述限位环203的产品外壳有可能发生断裂，当在所述限位环203上设置所述脱模槽204后，就会给予所述限位环203脱模时的回退空间，增加外壳结构的韧性，减轻以致杜绝产品在强脱过程中发生断裂的风险。
此外，在所述限位环203第二种设计方案下，所述脱模槽204给予了所述限位环203更大的回退空间，也就是说增大了所述限位环203的弹性，使其更容易越过所述凸棱件102从而卡合在所述凹槽中。
所述防护罩单元2还包括悬臂件205，其中：
所述悬臂件205远端设置在所述防护罩主体201近端上；
在所述防护罩主体201关闭时，所述悬臂件205近端卡合在所述凸棱件102远端上。
在本实施例中，所述悬臂件205为所述中止位件的一种表现形式，其远端端面为竖直平面，可以顶起所述凸棱件102的近端端面，使得在顶起状态下，所述防护罩主体201不会沿轴向向近端方向移动。
所述针座单元1还包括凹陷槽103；其中：
所述凹陷槽103设置在所述针安装件101上。
在本实施例中，所述凹陷槽103轴向开设在所述针安装件101上，使得所述针安装件101形成十字花的结构，这种结构在模具温度过高或者过低时，可以避免注塑缩水的问题，并且可以实现材料减肉，减轻注射器整体重量。
所述防护罩单元2还包括指尖凹槽206；其中：
所述指尖凹槽206设置在所述防护罩主体201远端；
所述指尖凹槽206用于打开所述防护罩主体201时供手指指肚捏持发力。
在本实施例中，所述限位环203第二种设计方案下，为了使得所述限位环203会越过所述凸棱件102，需要对所述防护罩主体201施加较大的轴向力，但是所述防护罩主体201的表面较为光滑，不好发力，并且在一旦手指发生滑动，会存在扎到所述针6上的风险，所以设置了所述指尖凹槽206，使用者的手指可以抵在所述指尖凹槽206的内侧面上，便于发力。
所述防护罩单元2还包括导力凸起条207；其中：
所述导力凸起条207设置在所述指尖凹槽206内侧底面上；
所述导力凸起条207用于提高手指指肚捏持时的摩擦阻力。
在本实施例中，所述指尖凹槽206内侧底面仍为光滑面，为了提高其摩擦阻力，在所述指尖凹槽206内侧底面上设置了多个所述导力凸起条207，一般为三个，使用者手指捏持过程中可以更牢固的与所述指尖凹槽206内侧底面贴合，不会发生错位现象。
一种带有前置护罩的预灌封注射器的组装件，包括注射活塞，以及通过插接作用安装在所述注射活塞上的注射推杆。
在本实施例中，所述注射活塞用于将所述注射器筒5内的药液推出完成注射过程，所述注射推杆为推动所述注射活塞的器件。
一种带有前置护罩的预灌封注射器的组装件的组装方法，包括以下步骤：
a.将所述针套3首先安装在所述防护罩单元2中，且将所述针套3远端顶起所述止位钩202。
b. 将所述防护罩单元2安装在所述针安装件101上，同时所述针套3套接在所述针6上。
在本实施例中，所述针套3顶起所述止位钩202时，即安装到了规定位置，将所述防护罩单元2安装在所述针安装件101上的同时，另外使用一个抓持装置将所述针套3对准针6并推动所述针套3安装在所述针6上，完成密封。
一种带有前置护罩的预灌封注射器的组装件的药品灌封方法，包括以下步骤：
a.将所述注射器筒5竖直放置，并向所述注射器筒5灌注液体药品，使得液面与所述注射器筒5的内侧面垂直；
b.利用套筒将所述注射活塞放入所述注射器筒5中，所述注射活塞与药品液面之间不留有空气；
c.将所述注射推杆插入所述注射器筒5中并安装在所述注射活塞上。
在本实施例中，灌注药品时，液体药品的液面与所述注射器筒5的内侧面垂直的目的在于，使得下一步安装所述注射活塞时，可与所述药品液面之间不留有空气。
此外，所述注射活塞安装在所述套筒中呈压缩状态，意味着所述套筒与所述注射器筒5之间留有孔隙，用于排出气体，所述注射活塞安装在所述注射器筒5之后，直径扩张并抵在所述注射器筒5内侧面上，实现了“药品灌封”的效果。
上面结合附图对本发明的实施方式作了详细说明，但是本发明不限于上述实施方式，在所述技术领域普通技术人员所具备的知识范围内，还可以在不脱离本发明宗旨的前提下做出各种修改。这些都是不具有创造性的修改，只要在本发明的权利要求范围内都受到专利法的保护。

Claims (14)

  1. 一种带有前置护罩的预灌封注射器，包括针（6），注射器筒（5），以及针套（3），其特征在于，还包括针座单元（1），以及防护罩单元（2），其中：
    所述针（6），注射器筒（5），针套（3），针座单元（1），以及防护罩单元（2）同轴线设置；
    所述防护罩单元（2）包括下止位件和上止位件；
    所述下止位件靠近所述防护罩单元（2）远端侧，所述上止位件靠近所述防护罩单元（2）近端侧；
    所述下止位件和上止位件的最小内径均小于所述注射器筒（5）的最大外径，并且所述上止位件的最小内径还小于所述针座单元（1）的最大外径；
    在所述防护罩单元（2）打开时，所述上止位件内径可扩张，使其最小内径大于所述注射器筒（5）的最大外径。
  2. 根据权利要求1所述的一种带有前置护罩的预灌封注射器，其特征在于，所述防护罩单元（2）还包括中止位件，其中：
    所述下止位件位于所述下止位件和上止位件中间；
    所述中止位件的最小内径小于所述针座单元（1）的最大外径；
    在防护罩单元（2）打开时，所述中止位件内径可扩张，使其最小内径大于所述针座单元（1）的最大外径处。
  3. 根据权利要求2所述的一种带有前置护罩的预灌封注射器，其特征在于，所述防护罩单元（2）包括防护罩主体（201），以及止位钩（202），其中：
    所述止位钩（202）远端连接所述防护罩主体（201）近端；
    所述止位钩（202）的近端与所述针座单元（1）最大外径处近端一侧贴合。
  4. 根据权利要求3所述的一种带有前置护罩的预灌封注射器，其特征在于，所述防护罩单元（2）还包括限位环（203），其中：
    所述限位环（203）设置在所述防护罩主体（201）远端；
    所述限位环（203）的近端与所述注射器筒（5）最大外径处远端一侧贴合。
  5. 根据权利要求3所述的一种带有前置护罩的预灌封注射器，其特征在于，所述止位钩（202）包括弹性件（202a），以及卡合件（202b）；其中：
    所述弹性件（202a）远端设置在所述防护罩主体（201）近端上；
    所述卡合件（202b）设置在所述弹性件（202a）近端上；
    所述卡合件（202b）远端与所述针座单元（1）的最大外径处近端一侧贴合。
  6. 根据权利要求5所述的一种带有前置护罩的预灌封注射器，其特征在于，还包括回缩端头（4），其中：
    所述回缩端头（4）设置在所述注射器筒（5）远端，且用于安装所述针座单元（1）；
    所述回缩端头（4）远端具有斜面，在所述防护罩主体（201）打开时，使得所述卡合件（202b）越过所述回缩端头（4）。
  7. 根据权利要求6所述的一种带有前置护罩的预灌封注射器，其特征在于，所述止位钩（202）还包括近端斜面（202c），其中；
    所述近端斜面（202c）设置在所述卡合件（202b）近端，在所述防护罩主体（201）打开时，使所述卡合件（202b）越过所述回缩端头（4）。
  8. 根据权利要求6所述的一种带有前置护罩的预灌封注射器，其特征在于，所述针座单元（1）包括针安装件（101），以及凸棱件（102），其中：
    所述针（6）安装在所述针安装件（101）近端上；
    所述凸棱件（102）安装在所述针安装件（101）远端上；
    所述凸棱件（102）远端与所述中止位件近端贴合；
    所述凸棱件（102）近端与所述卡合件（202b）远端贴合。
  9. 根据权利要求8所述的一种带有前置护罩的预灌封注射器，其特征在于，所述凸棱件（102）最大外径小于所述回缩端头（4）最大外径。
  10. 根据权利要求4所述的一种带有前置护罩的预灌封注射器，其特征在于，所述防护罩单元（2）还包括脱模槽（204），其中：
    所述脱模槽（204）设置在所述限位环（203）上；
    所述脱模槽（204）给予所述限位环（203）内径扩大时的回缩空间。
  11. 根据权利要求8所述的一种带有前置护罩的预灌封注射器，其特征在于，所述防护罩单元（2）还包括悬臂件（205），其中：
    所述悬臂件（205）远端设置在所述防护罩主体（201）近端上；
    在所述防护罩主体（201）关闭时，所述悬臂件（205）近端贴合在所述凸棱件（102）远端上。
  12. 根据权利要求8所述的一种带有前置护罩的预灌封注射器，其特征在于，所述针座单元（1）还包括凹陷槽（103）；其中：
    所述凹陷槽（103）设置在所述针安装件（101）上。
  13. 根据权利要求3所述的一种带有前置护罩的预灌封注射器，其特征在于，所述防护罩单元（2）还包括指尖凹槽（206）；其中：
    所述指尖凹槽（206）设置在所述防护罩主体（201）远端；
    所述指尖凹槽（206）用于打开所述防护罩主体（201）时供手指指肚捏持发力。
  14. 根据权利要求13所述的一种带有前置护罩的预灌封注射器，其特征在于，所述防护罩单元（2）还包括导力凸起条（207）；其中：
    所述导力凸起条（207）设置在所述指尖凹槽（206）内侧底面上；
    所述导力凸起条（207）用于提高手指指肚捏持时的摩擦阻力。
PCT/CN2023/070630 2022-03-21 2023-01-05 一种带有前置护罩的预灌封注射器 Ceased WO2023179178A1 (zh)

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CN114642793A (zh) * 2022-03-21 2022-06-21 上海新耀湃科医疗科技股份有限公司 一种带有前置护罩的预灌封注射器
CN114796728B (zh) * 2022-05-07 2026-01-02 上海新耀湃科医疗科技股份有限公司 一种针头保护式预灌封针筒及其组件，组件的安装方法
CN117180556B (zh) * 2023-08-25 2024-06-14 上海新耀湃科医疗科技股份有限公司 一种防护式预灌封注射器
CN117182544B (zh) 2023-08-25 2026-01-13 上海新耀湃科医疗科技股份有限公司 一种预灌封注射器的组装方法

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