WO2023179179A1 - 一种针头防护式预灌封注射器 - Google Patents

一种针头防护式预灌封注射器 Download PDF

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Publication number
WO2023179179A1
WO2023179179A1 PCT/CN2023/070631 CN2023070631W WO2023179179A1 WO 2023179179 A1 WO2023179179 A1 WO 2023179179A1 CN 2023070631 W CN2023070631 W CN 2023070631W WO 2023179179 A1 WO2023179179 A1 WO 2023179179A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
cantilever
protective cover
cover unit
proximal end
Prior art date
Application number
PCT/CN2023/070631
Other languages
English (en)
French (fr)
Inventor
郭融
Original Assignee
上海新耀湃科医疗科技股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海新耀湃科医疗科技股份有限公司 filed Critical 上海新耀湃科医疗科技股份有限公司
Publication of WO2023179179A1 publication Critical patent/WO2023179179A1/zh

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202Devices for protection of the needle before use, e.g. caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3213Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning

Definitions

  • the invention belongs to the technical field of pre-filled syringes, and in particular relates to a needle-protected pre-filled syringe.
  • Prefilled syringes are a new form of pharmaceutical packaging. From another perspective, they can be understood as "an injectable pharmaceutical packaging". Since prefilled syringes are also a type of syringe, there is also a risk of the syringe needle injuring people when discarded after use. Therefore, in order to solve this problem, there is a device on the market that destroys the needle before discarding, such as the announcement number
  • the Chinese utility model patent CN210936412U with an announcement date of 2020-07-07, discloses a needle shearing device for an integrated syringe, which includes: a first shearing part, and the first shearing part is defined with a needle extending along its axial direction.
  • a first chamber with one end open, the first chamber can accommodate the syringe needle and the syringe to pass through, the other end of the first shearing member is provided with a first shearing port connected to the first chamber, the needle and the connecting part can Passing through the first shearing opening; a first blade, the first blade is provided at the first shearing opening; a second shearing member, the second shearing member defines a second cavity extending along its axial direction and with one end open.
  • one end of the second chamber is sleeved on the other end of the first shearing part, a driving part is provided in the second shearing part, and the second shearing part can rotate around its axis so that the driving part drives the connecting part to stop against the first blade and was broken by the first blade.
  • this shearing device has the following shortcomings: First, there is a lot of injection work in the hospital, and nurses even need to go to each ward to complete the injection task. It is very inappropriate to require nurses to carry the shearing device with them, and nurses cannot guarantee that they will remember to carry the shearing device at all times. Second, the shearing process may cause the needle to fly out, causing the needle to be lost or even directly injuring others; third, the sheared needle still needs to be discarded, although the volume of medical waste is greatly reduced and can be processed centrally. However, the problem of needle exposure when discarded has not been fundamentally solved, and centralized processing is also time-consuming and laborious.
  • the object of the present invention is to provide a needle-protected pre-filled syringe.
  • the invention uses an injection syringe, a needle, a needle mounting piece, a protective cover unit and a needle cover unit to cover the needle, thereby preventing the syringe from stabbing others during the discarding process. technical effects.
  • a needle-protected pre-filled syringe which includes an injection syringe, a needle, a needle mounting piece, a protective cover unit and a needle cover unit;
  • the needle is mounted on the needle mounting piece
  • the needle cover unit is sleeved on the needle and part of the needle mounting piece;
  • the protective cover unit is sleeved on the needle cover unit and part of the injection syringe;
  • the protective cover unit includes a protective cover main body and a front engaging piece provided on the protective cover main body;
  • the needle mounting member is disposed at the distal end of the injection syringe, and forms a groove with the injection syringe for engaging the front engaging member.
  • the protective cover unit further includes a rear engaging piece on the protective cover main body; wherein:
  • the proximal end of the rear engaging member axially pushes up the distal end of the maximum outer diameter of the needle mounting member.
  • the protective cover unit further includes a wide stop hook; wherein:
  • the distal end of the wide stop hook is connected to the proximal end of the protective cover body, and the proximal end of the wide stop hook is engaged in the groove.
  • the protective cover unit further includes a cantilever member and a cantilever port; wherein:
  • the cantilever port is provided on the wide stop hook
  • the cantilever component is installed on the inner side of the cantilever port.
  • a further preferred technical solution is that the cantilever port extends distally to part of the main body of the protective cover.
  • the protective cover unit further includes a narrow stop hook; wherein:
  • the distal end of the narrow stop hook is connected to the proximal end of the protective cover body, and the proximal end of the narrow stop hook is engaged with the proximal side of the maximum outer diameter of the needle mounting member;
  • the narrow stop hook is arranged between the two wide stop hooks.
  • a further preferred technical solution is that the wide stop hooks are arranged symmetrically.
  • a further preferred technical solution is that the narrow stop hooks are arranged symmetrically.
  • the cantilever member includes a cantilever elastic member and a cantilever engaging member; wherein;
  • the distal end of the cantilever elastic member is arranged on the inner side of the cantilever mouth;
  • the distal end of the cantilever engaging member is disposed on the proximal end of the cantilever elastic member
  • the proximal end of the cantilever engaging member abuts the proximal side of the maximum outer diameter of the needle mounting member.
  • the cantilever member further includes a proximal chamfer; wherein:
  • the proximal chamfer is provided at the proximal end of the cantilever engaging member so that when the protective cover body is opened, the cantilever engaging member passes over the maximum outer diameter of the needle mounting member.
  • the cantilever member further includes a distal chamfer; wherein:
  • the distal chamfer is provided at the distal end of the cantilever engaging member so that the cantilever engaging member passes over the maximum outer diameter of the needle mounting member when the protective cover body is closed.
  • the needle mounting part includes a ridge part; wherein:
  • the distal end of the convex rib member engages with the cantilever engaging member, and the proximal end of the convex rib member engages with the wide stop hook and the narrow stop hook.
  • the needle mounting member includes a convex edge chamfer; wherein:
  • the convex edge chamfer is provided on the distal end of the convex edge component, so that when the protective cover main body is opened, the cantilever engaging component passes over the convex edge component.
  • a component of a needle-protected pre-filled syringe further includes a sealing plug, and a push rod inserted into the sealing plug.
  • a method for installing components of a needle-protected prefilled syringe including the following steps:
  • the first step install the needle cover unit into the main body of the protective cover;
  • Step 2 Install the protective cover body and needle cover unit on the needle mounting piece
  • Step 3 Install the sealing plug in the injection syringe
  • Step 4 Install the push rod on the sealing plug.
  • a drug filling method for components of a needle-protected pre-filled syringe including the following steps:
  • multiple stop hooks are provided at the proximal end of the protective cover to improve the stability of the protective cover after it is fixed.
  • the stop hooks are in close contact with the surface of the syringe, so that the protective cover is fixed on the outer ring of the syringe. The surface effect will not slip during the injection process.
  • a hollow structure is designed on the stop hook, and a cantilever and stop hook are combined to fix the protective cover in it, so that the force is evenly distributed.
  • the cantilever is provided with a chamfer structure corresponding to the main part of the syringe, making the process of passing over the convex parts smoother and less likely to get stuck.
  • Figure 1 is an exploded view of the overall structure of the prefilled syringe of the present invention.
  • Figure 2 is a schematic structural diagram of the protective cover unit installed on the needle mounting piece when the needle cover unit is not covered on the needle head in the present invention.
  • Figure 3 is a schematic structural diagram of the protective cover unit being installed on the needle mounting piece when the needle cover unit is wrapped on the needle head according to the present invention.
  • Figure 4 is a schematic structural diagram of the protective cover unit in the present invention.
  • FIG. 5 is a cross-sectional view cut along line AA in FIG. 2 .
  • FIG. 6 is a cross-sectional view taken along line BB in FIG. 3 .
  • Figure 7 is an enlarged view of area A in Figure 5.
  • each number is as follows: injection syringe 11, needle 12, needle mounting part 1, protective cover unit 2, needle cover unit 3, convex edge part 101, convex edge chamfer 102, protective cover main body 201 , wide stop hook 202, cantilever member 203, cantilever mouth 204, narrow stop hook 205, cantilever elastic member 203a, cantilever engaging member 203b, proximal chamfer 203c, distal chamfer 203d.
  • Distal end refers to the end facing the needle.
  • Proximal end refers to the end far away from the needle.
  • Axis refers to an object with a regular cross-section, and the vertical line through which the cross-section passes through its centroid.
  • Opening direction refers to the direction in which the needle or needle cover unit can be exposed during operation.
  • Closing direction refers to the direction that can cover the needle or needle cover unit 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 needle-protected pre-filled syringe includes an injection syringe 11, a needle 12, a needle mounting part 1, a protective cover unit 2 and a needle cover unit 3; wherein :
  • the needle 12 is installed on the needle mounting member 1;
  • the needle cover unit 3 is sleeved on the needle 12 and part of the needle mounting member 1;
  • the protective cover unit 2 is sleeved on the needle cover unit 3 and part of the injection syringe 11;
  • the protective cover unit 2 includes a protective cover main body 201 and a front engaging piece provided on the protective cover main body 201;
  • the needle mounting member 1 is disposed at the distal end of the injection syringe 11 and forms a groove with the injection syringe 11 for engaging the front engaging member.
  • the injection syringe 11 and the needle 12 constitute a syringe device commonly used in the prior art.
  • the injection syringe 11 is not provided with a push rod, but is provided by a downstream manufacturer. After the medicine is filled, the appropriate push rod is added according to the specifications of the syringe 11 to ensure the sealing performance.
  • the entire protective cover unit 2 is first connected to the needle sleeve unit 3, and then during the installation process The needle cover unit 3 is covered with the needle head 12 , and a part of the protective cover unit 2 is sleeved on the needle mounting member 1 .
  • the first step is to push the protective cover unit 2 proximally to expose the needle cover unit 3;
  • the third step is to push the push rod to perform the injection operation
  • the fourth step is to push the protective cover unit 2 to the distal end, re-cover the needle 12 and discard it.
  • the protective cover main body 201 and the front engaging piece are the main components of the protective cover unit 2, and the protective cover main body 201 is disposed at the far end of the entire protective cover unit 2.
  • the front engaging piece is disposed on the proximal side of the protective cover unit 2, and the minimum inner diameter of the front engaging piece is smaller than the maximum outer diameter of the needle mounting piece 1 and the injection syringe 11, so that In the fourth step, the front engaging member engages with the groove to cause the protective cover body 201 to stay in a position covering the needle 12, thereby achieving a protective effect.
  • the front latch can be expanded so that its minimum inner diameter is larger than the maximum outer diameter of the injection syringe 11, so that in the first step, the shield body 201 slides proximally to unlock it.
  • the injection operation is performed by coating the needle 12 .
  • the protective cover unit 2 also includes a rear engaging piece on the protective cover main body 201; wherein
  • the proximal end of the rear engaging member axially pushes up the distal end of the maximum outer diameter of the needle mounting member 1 .
  • the groove is a naturally formed feature between the maximum outer diameter of the needle mounting member 1 and the injection syringe 11.
  • the front engaging member When the front engaging member is engaged in the groove When, its distal end will axially push up the proximal end at the maximum outer diameter of the needle mounting part 1, and at the same time, the proximal end of the rear engaging piece axially lifts up the distal end at the maximum outer diameter of the needle mounting part 1 , in this way, the front engaging part and the rear engaging part cooperate to clamp the maximum outer diameter of the needle mounting part 1, thereby firmly fixing the protective cover main body 201 in the fourth step. , instead of relying solely on the force of the front engaging member engaging in the groove.
  • the rear engaging member in order to smoothly push the protective cover body 201, can be manually expanded to release the engagement state with the maximum outer diameter of the needle mounting member 1, Thus, the protective cover body 201 is smoothly pushed.
  • the needle cover unit 3 when the needle cover unit 3 exists, the needle cover unit 3 will radially push up the rear engaging member so that it is released from the maximum outer diameter of the needle mounting member 1
  • the shield body 201 can be pushed only by pushing force.
  • the needle cover unit 3 has been removed, and when the rear engaging member engages the maximum outer diameter of the needle mounting member 1 again, the position of the protective cover body 201 cannot be adjusted solely by pushing force, which plays a role in adjusting the position of the protective cover body 201.
  • the protective effect of the needle C when the needle cover unit 3 exists, there is no need to manually expand, and the shield body 201 can be pushed only by pushing force.
  • the protective cover unit 2 also includes a wide stop hook 202; wherein:
  • the distal end of the wide stop hook 202 is connected to the proximal end of the protective cover body 201, and the proximal end of the wide stop hook 202 is engaged in the groove.
  • the wide stop hook 202 is a form of the front engaging piece, and its proximal end has a radially extending engaging block for engaging in the groove. That is, the proximal end surface at the maximum outer diameter of the needle mounting member 1 is axially pushed up.
  • the wide stop hook 202 itself is elastic and can expand the inner diameter through bending, thereby exceeding the groove and releasing the engagement state. .
  • the protective cover unit 2 also includes a cantilever member 203 and a cantilever port 204; wherein:
  • the cantilever port 204 is provided on the wide stop hook 202;
  • the cantilever member 203 is installed on the inner side of the cantilever port 204 .
  • the cantilever member 203 is one of the forms of the rear engaging member
  • the cantilever port 204 is disposed close to the distal side of the wide stop hook 202
  • the cantilever member 203 is one of the forms of the rear engaging member.
  • 203 is disposed on the inner side of the distal side of the cantilever port 204 and extends toward the proximal side, so that the proximal end of the cantilever port 204 and the proximal end of the wide stop hook 202 form a clamping component.
  • the locking effect is achieved at the maximum outer diameter of the needle mounting member 1 .
  • the cantilever member 203 is installed by setting the cantilever port 204 so that the cantilever member 203 is integrated with the wide stop hook 202.
  • the cantilever member 203 is the wide stop hook.
  • the position hook 202 is integrally prepared, so that the cantilever member 203 does not tilt up.
  • the advantage of this is that the nurse can grasp the protective cover unit 2 with a gesture similar to holding a pencil when injecting. This is unnecessary.
  • the angular design greatly improves the comfort of the nurse during use. Compared with other products on the market with protruding cantilevers, the use experience is better.
  • the cantilever opening 204 extends distally to part of the protective cover body 201 .
  • the extension of the cantilever port 204 makes the internal space larger, and the cantilever member 203 with a longer radial length can be installed, which actually increases the radial expansion range of the cantilever member 203. This makes it easier to cross the maximum outer diameter of the needle mount 1 when opening the shield body 201 .
  • the protective cover unit 2 also includes a narrow stop hook 205; wherein:
  • the distal end of the narrow stop hook 205 is connected to the proximal end of the protective cover body 201, and the proximal end of the narrow stop hook 205 engages with the proximal side of the maximum outer diameter of the needle mounting member 1;
  • the narrow stop hook 205 is provided between the two wide stop hooks 202 .
  • the actual function of the narrow stop hook 205 is the same as that of the wide stop hook 202.
  • the difference is that the cantilever member 203 is not installed on the narrow stop hook 205 and only serves as a restriction.
  • the shield body 201 moves radially toward the distal end, but this design makes full use of the vacant position between the wide stop hooks 202 .
  • two wide stop hooks 202 are generally provided at the proximal end of the protective cover body 201.
  • a balancing force can be provided, that is, the narrow stop hooks 205 can provide a balancing force.
  • the wide stop hooks 202 are arranged symmetrically.
  • the narrow stop hooks 205 are arranged symmetrically.
  • the wide stop hook 202 and the narrow stop hook 205 are symmetrically designed, which on the one hand makes the protective cover unit 2 more beautiful, on the other hand keeps the engagement force balanced and reduces the protection The cover body 201 shakes.
  • the cantilever member 203 includes a cantilever elastic member 203a and a cantilever engaging member 203b, wherein;
  • the distal end of the cantilever elastic member 203a is provided on the inner side of the cantilever port 204;
  • the distal end of the cantilever engaging member 203b is provided on the proximal end of the cantilever elastic member 203a;
  • the proximal end of the cantilever engaging member 203b abuts the proximal side of the maximum outer diameter of the needle mounting member 1 .
  • the cantilever member 203 is composed of two parts.
  • the first part is a cantilever elastic member 203a provided on the cantilever installation opening 204 and bent radially toward the protective cover body 201.
  • the engaging member 203b is disposed on the end surface of the end of the cantilever elastic member 203a, so that the end surface of the cantilever engaging member 203b can be pushed together with the distal end surface at the maximum outer diameter of the needle mounting member 1, and used for When it is closed, it pushes up the distal end surface at the maximum outer diameter of the needle mounting member 1, and when it is opened, it exerts a friction limiting effect on the surface of the needle barrel body A.
  • the cantilever member 203 also includes a proximal chamfer 203c; where:
  • the proximal chamfer 203c is provided at the proximal end of the cantilever engaging member 203b, so that the cantilever engaging member 203b passes over the maximum outer diameter of the needle mounting member 1 when the shield body 201 is opened.
  • the proximal chamfer 203c axially pushes up the distal end surface at the maximum outer diameter of the needle mounting member 1, which will A radial force is generated, driving the cantilever elastic member 203a to expand radially, thereby crossing the maximum outer diameter of the needle mounting member 1, so that the shield body 201 continues to move axially.
  • the cantilever member 203 also includes a distal chamfer 203d; where:
  • the distal chamfer 203d is provided at the distal end of the cantilever engaging member 203b so that the cantilever engaging member 203b passes over the maximum outer diameter of the needle mounting member 1 when the shield body 201 is closed.
  • the distal chamfer 203d axially pushes up the proximal end surface at the maximum outer diameter of the needle mounting member 1, driving
  • the cantilever elastic member 203a expands radially to cross the maximum outer diameter of the needle mounting member 1, so that the cantilever engaging member 203b engages with the distal end of the maximum outer diameter of the needle mounting member 1.
  • the needle mounting part 1 includes a ridge part 101, wherein:
  • the distal end of the rib member 101 engages with the cantilever engaging member 203b, and the proximal end of the rib member 101 engages with the wide stop hook 202 and the narrow stop hook. 205 snaps together.
  • the rib member 101 is a form of expression at the maximum outer diameter of the needle mounting member 1, and its function is to lift its distal end from the cantilever engaging member 203b, and its proximal end from the cantilever engaging member 203b.
  • the wide stop hook 202 and the narrow stop hook 205 push up and form an annular groove with the injection syringe 11 for engaging the proximal ends of the wide stop hook 202 and the narrow stop hook 205 Snap block.
  • the rib member 101 prevents the protective cover body 201 from being disengaged no matter how it is rotated once it is locked.
  • the needle mount 1 includes a convex edge chamfer 102, wherein:
  • the convex edge chamfer 102 is provided on the distal end of the convex edge member 101, so that the cantilever engaging member 203b passes over the convex edge member 101 when the protective cover main body 201 is opened.
  • the chamfer slope of the convex edge chamfer 102 is the same as the distal chamfer 203d, so that in the first step, the distal chamfer 203d offsets the convex edge chamfer 102, so that The radial expansion force of the cantilever elastic member 203a is increased, making it easier for the cantilever member 203 to pass over the ridge member 101.
  • a component of a needle-protected pre-filled syringe further includes a sealing plug, and a push rod inserted into the sealing plug.
  • an engaging groove for installing one end of the push rod is left behind the sealing plug.
  • a method for installing components of a needle-protected prefilled syringe including the following steps:
  • the first step install the needle cover unit 3 into the protective cover body 2;
  • Step 2 Install the protective cover body 2 and the needle sleeve unit 3 on the needle mounting piece 1;
  • Step 3 Install the sealing plug in the injection syringe 11;
  • Step 4 Install the push rod on the sealing plug.
  • the protective cover main body 2 and the needle sleeve unit 3 are installed together in a simpler manner, which is convenient for application in an assembly line installation process.
  • a drug filling method for components of a needle-protected pre-filled syringe including the following steps:
  • the sealing plug is installed behind the injection syringe 11, and there is no air left in the injection syringe 11, so the operator can directly inject.

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  • Engineering & Computer Science (AREA)
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Abstract

一种针头防护式预灌封注射器。通过注射针筒(11),针头(12),针安装件(1),防护罩单元(2)以及针套单元(3)起到了包覆针头(12)从而避免注射器在丢弃过程中刺伤他人的技术效果,具有以下优点:第一,利用防扩罩单元(2)对针头(12)进行包覆,使得针头(12)不会暴露刺伤他人,并且露出针头(12)的同时,防护罩单元(2)不会与针筒(11)脱离;第二,设置多个止位钩(202,205),在打开防护罩单元(2)时实现固定在针筒(11)外环面的效果,在注射过程中不会下滑;第三,在止位钩(202,205)上设计了中空结构,并在其中设置了悬臂(203)与止位钩(202,205)联合固定防护罩单元(2),受力均匀;第四,悬臂(203)上设有与注射器主体部分相对应的倒角结构(203c,203d),使其越过凸棱件(101)的过程更加顺滑,不易产生卡死现象。

Description

一种针头防护式预灌封注射器 技术领域
本发明属于预灌封注射器技术领域,尤其涉及一种针头防护式预灌封注射器。
背景技术
预灌封注射器是一种新型的药品包装形式,从另一个角度来看,可以理解成“一种可注射式的药品包装”。由于预灌封注射器亦为注射器的一种,所以也存在着使用后丢弃时注射器针头伤人的风险,所以为了解决这一问题,市场上存在一种在丢弃前破坏针头的装置,例如公告号为CN210936412U,公告日为2020-07-07的中国实用新型专利公开了一种一体式注射器的针头剪切装置,包括:第一剪切件,第一剪切件内限定有沿其轴向延伸且一端敞开的第一腔室,第一腔室能够容纳注射器针头和注射器穿过,第一剪切件的另一端设有与第一腔室连通的第一剪切口,针头和连接部能够穿过第一剪切口;第一刀片,第一刀片设在第一剪切口处;第二剪切件,第二剪切件内限定有沿其轴向延伸且一端敞开的第二腔室,第二腔室的一端套设在第一剪切件的另一端上,第二剪切件内设有驱动部,第二剪切件绕其轴线可转动以使驱动部带动连接部止抵第一刀片并被第一刀片折断。
但是,这种剪切装置具有下列缺点:第一,医院注射工作繁多,甚至需要护士去每个病房完成注射任务,要求护士随身携带剪切装置十分不妥,且护士不能保证随时都会记得携带剪切装置;第二,剪切过程有几率会导致针头飞出,造成针头丢失甚至直接伤害他人;第三,剪切后的针头依旧需要丢弃,虽然大大减少了医疗废物的体积量可以集中处理,但是没有从根本上解决丢弃时针头露出的问题,集中处理也要费时费力。
技术问题
所以综上所述,为了解决这一问题,目前急需一种保证使用后丢弃时不会露出针头刺伤他人的预灌封注射器。
技术解决方案
本发明目的是提供一种针头防护式预灌封注射器,本发明通过注射针筒,针头,针安装件,防护罩单元以及针套单元起到了包覆针头从而避免注射器在丢弃过程中刺伤他人的技术效果。
本发明解决上述问题采用的技术方案是:一种针头防护式预灌封注射器,包括注射针筒,以及针头,还包括针安装件,防护罩单元以及针套单元;其中:
所述针头安装在所述针安装件上;
所述针套单元套接在所述针头及部分所述针安装件上;
所述防护罩单元套接在所述针套单元及部分所述注射针筒上;
所述防护罩单元包括防护罩主体,以及设置在所述防护罩主体上的前卡合件;
所述针安装件设置在所述注射针筒远端,并与所述注射针筒之间形成凹槽用于卡合所述前卡合件。
进一步优选的技术方案在于:所述防护罩单元还包括所述防护罩主体上的后卡合件;其中:
所述后卡合件近端轴向顶起所述针安装件的最大外径处远端。
进一步优选的技术方案在于:所述防护罩单元还包括宽止位钩;其中:
所述宽止位钩远端连接所述防护罩主体近端,所述宽止位钩近端卡合在所述凹槽中。
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,以及悬臂口;其中:
所述悬臂口设置在所述宽止位钩上;
所述悬臂件安装在所述悬臂口内侧面上。
进一步优选的技术方案在于:所述悬臂口向远端延伸至部分所述防护罩主体上。
进一步优选的技术方案在于:所述防护罩单元还包括窄止位钩;其中:
所述窄止位钩远端连接所述防护罩主体近端,所述窄止位钩近端与所述针安装件最大外径处近端一侧卡合;
所述窄止位钩设置在两个所述宽止位钩之间。
进一步优选的技术方案在于:所述宽止位钩对称设置。
进一步优选的技术方案在于:所述窄止位钩对称设置。
进一步优选的技术方案在于:所述悬臂件包括悬臂弹性件,以及悬臂卡合件;其中;
所述悬臂弹性件远端设置在所述悬臂口内侧面上;
所述悬臂卡合件远端设置在所述悬臂弹性件近端上;
所述防护罩主体关闭时,所述悬臂卡合件近端抵在所述针安装件最大外径处近端一侧。
进一步优选的技术方案在于:所述悬臂件还包括近端倒角;其中:
所述近端倒角设置在所述悬臂卡合件近端,在所述防护罩主体打开时,使悬臂卡合件越过所述针安装件的最大外径处。
进一步优选的技术方案在于:所述悬臂件还包括远端倒角;其中:
所述远端倒角设置在所述悬臂卡合件远端,在所述防护罩主体关闭时,使所述悬臂卡合件越过所述针安装件的最大外径处。
进一步优选的技术方案在于:所述针安装件包括凸棱件;其中:
在所述防护罩主体关闭时,所述凸棱件远端与所述悬臂卡合件卡合,所述凸棱件近端与所述宽止位钩和窄止位钩卡合。
进一步优选的技术方案在于:所述针安装件包括凸棱倒角;其中:
所述凸棱倒角设置在所述凸棱件远端上,在所述防护罩主体打开时,使所述悬臂卡合件越过所述凸棱件。
一种针头防护式预灌封注射器的部件,还包括密封塞,以及插接设置在所述密封塞上的推动杆。
一种针头防护式预灌封注射器的部件的安装方法,包括以下步骤:
第一步:将所述针套单元装入所述防护罩主体中;
第二步:将所述防护罩主体和针套单元安装在所述针安装件上;
第三步:将所述密封塞安装在所述注射针筒中;
第四步:将所述推动杆安装在所述密封塞上。
一种针头防护式预灌封注射器的部件的药品灌封方法,包括以下步骤:
1.将所述注射针筒开口向上并垂直于水平面放置,并向所述注射针筒中灌注定量液体药品;
2.将所述密封塞,通过套筒安装在所述注射针筒中,所述套筒最大外径小于所述注射针筒最小内径;
3.将所述推动杆安装在所述密封塞上。
有益效果
本发明具有以下优点:
第一,利用可轴向活动的防护罩对针头进行包覆,使得针头不会暴露刺伤他人,并且通过防护罩的滑动,可以在注射过程中露出针头的同时,防护罩不会与针筒脱离,便于注射完毕后直接推回,重新包覆针头然后丢弃。
第二,在防护罩近端设置多个止位钩,提高防护罩固定后的稳定性,并且在打开防护罩时,止位钩与针筒表面紧贴,实现防护罩固定在针筒外环面上的效果,在注射过程中不会下滑。
第三,在止位钩上设计了中空结构,并在其中设置了悬臂与止位钩联合固定防护罩,受力均匀。
第四,悬臂上设有与注射器主体部分相对应的倒角结构,使其在越过凸棱件的过程更加顺滑,不易产生卡死现象。
附图说明
图1为本发明中预灌装注射器整体结构的爆炸图。
图2为本发明中针套单元未包覆在针头上时,防护罩单元安装在针安装件上的结构示意图。
图3为本发明中针套单元包覆在针头上时,防护罩单元安装在针安装件上的结构示意图。
图4为本发明中防护罩单元的结构示意图。
图5为图2中沿AA线切割形成的剖面图。
图6为图3中沿BB线切割形成的剖面图。
图7为图5中区域A的放大图。
附图中,各标号所代表的部件如下:注射针筒11,针头12,针安装件1,防护罩单元2,针套单元3,凸棱件101,凸棱倒角102,防护罩主体201,宽止位钩202,悬臂件203,悬臂口204,窄止位钩205,悬臂弹性件203a,悬臂卡合件203b,近端倒角203c,远端倒角203d。
本发明的实施方式
定义:
1.远端:指朝向所述针头一端。
2.近端:指远离所述针头一端。
3.轴线:指具有规整横截面的物体,截面经过其形心的垂直线。
4.打开方向:指在操作过程中能够暴露出所述针头或者针套单元的方向。
5.关闭方向:指在操作过程中能够包覆所述针头或者针套单元的方向。
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1-7所示,一种针头防护式预灌封注射器,包括注射针筒11,以及针头12,还包括针安装件1,防护罩单元2以及针套单元3;其中:
所述针头12安装在所述针安装件1上;
所述针套单元3套接在所述针头12及部分所述针安装件1上;
所述防护罩单元2套接在所述针套单元3及部分所述注射针筒11上;
所述防护罩单元2包括防护罩主体201,以及设置在所述防护罩主体201上的前卡合件;
所述针安装件1设置在所述注射针筒11远端,并与所述注射针筒11之间形成凹槽用于卡合所述前卡合件。
在本实施例中,所述注射针筒11以及针头12构成了现有技术中常用的注射器装置,为了方便预灌装药品,在所述注射针筒11中未设置推杆,而由下游厂家经药品灌装后,自行根据所述针筒11的规格添加合适的所述推杆,以保证密封性能,所述防护罩单元2整体先套接在所述针套单元3,然后在安装过程中连同所述针套单元3一同包覆在所述针头12,并且所述防护罩单元2的一部分套接在所述针安装件1上。
灌装药品后,针筒的使用方法为:
第一步,向近端推动所述防护罩单元2,露出所述针套单元3;
第二步,取下所述针套单元3,使得所述针头12露出;
第三步,推动推杆进行注射作业;
第四步,将所述防护罩单元2向远端推动,重新包覆所述针头12,并丢弃。
此外,优选的情况下,所述防护罩主体201和所述前卡合件为所述防护罩单元2的主要组成部分,所述防护罩主体201设置在所述防护罩单元2整体远端一侧,所述前卡合件设置在所述防护罩单元2整体近端一侧,所述前卡合件最小内径处小于所述针安装件1以及注射针筒11的最大外径处,这样在第四步时,所述前卡合件通过与所述凹槽的卡合作用即可使得所述防护罩主体201停留在包覆所述针头12的位置,从而实现保护作用。
此外,所述前卡合件可通过扩张使其最小内径处大于所述注射针筒11的最大外径处,这样在第一步时,所述防护罩主体201向近端滑动,从而解开对所述针头12的包覆作用而进行注射作业。
所述防护罩单元2还包括所述防护罩主体201上的后卡合件;其中
所述后卡合件近端轴向顶起所述针安装件1的最大外径处远端。
在本实施例中,所述凹槽即为所述针安装件1的最大外径处与所述注射针筒11自然形成的特征,当所述前卡合件卡合在所述凹槽中时,其远端会轴向顶起所述针安装件1的最大外径处近端,同时所述后卡合件近端轴向顶起所述针安装件1的最大外径处远端,这样一来,所述前卡合件和后卡合件配合对所述针安装件1的最大外径处起到了夹持作用,从而在第四步时牢牢固定所述防护罩主体201,而不必仅靠所述前卡合件卡合在所述凹槽中的作用力。
此外,在第一步时,为了顺利推动所述防护罩主体201,可通过手动扩张所述后卡合件的方式使其解除与所述针安装件1的最大外径处的卡合状态,从而顺利推动所述防护罩主体201。
此外,优选的情况下,当所述针套单元3存在时,所述针套单元3会径向顶起所述后卡合件,使其解除与所述针安装件1的最大外径处的卡合状态,这样的好处在于,当所述针套单元3存在时,无需手动扩张,仅靠推动力即可推动所述防护罩主体201,而当第四步时,所述针套单元3已被取下,这时所述后卡合件再次卡合所述针安装件1的最大外径处时,便不能仅靠推动力来调整所述防护罩主体201的位置,起到了对所述针头C的保护作用。
所述防护罩单元2还包括宽止位钩202;其中:
所述宽止位钩202远端连接所述防护罩主体201近端,所述宽止位钩202近端卡合在所述凹槽中。
在本实施例中,所述宽止位钩202即为所述前卡合件的一种表现形式,其近端具有径向延伸的卡合块,用于卡合在所述凹槽中,即轴向顶起所述针安装件1的最大外径处近端面,所述宽止位钩202本身具有弹性,可通过弯曲进行内径扩张,从而越出所述凹槽,解除卡合状态。
所述防护罩单元2还包括悬臂件203,以及悬臂口204;其中:
所述悬臂口204设置在所述宽止位钩202上;
所述悬臂件203安装在所述悬臂口204内侧面上。
在本实施例中,所述悬臂件203为所述后卡合件的其中一种表现形式,所述悬臂口204靠向所述宽止位钩202远端侧进行设置,并且所述悬臂件203设置在所述悬臂口204远端侧的内侧面上,并向近端侧延伸,这样所述悬臂口204的近端与所述宽止位钩202的近端形成一个夹持部件,用于夹持所述针安装件1的最大外径处实现卡合作用。
此外,通过设置所述悬臂口204安装所述悬臂件203,使得所述悬臂件203与所述宽止位钩202一体化,事实上在制备时,所述悬臂件203即为所述宽止位钩202中一体制备而成,便没有了所述悬臂件203翘起的情况,这样的好处在于,护士在注射时会以类似拿铅笔的手势抓握所述防护罩单元2,这种无棱角的设计大大提高了护士使用过程的舒适度,相比于市场上其他悬臂突出的产品,使用体验更佳。
所述悬臂口204向远端延伸至部分所述防护罩主体201上。
在本实施例中,所述悬臂口204延伸后使其内部空间更大,可以安装径向长度更长的所述悬臂件203,事实上提高了所述悬臂件203径向扩张的活动范围,使其更容易在打开所述防护罩主体201时越过所述针安装件1的最大外径处。
所述防护罩单元2还包括窄止位钩205;其中:
所述窄止位钩205远端连接所述防护罩主体201近端,所述窄止位钩205近端与所述针安装件1最大外径处近端一侧卡合;
所述窄止位钩205设置在两个所述宽止位钩202之间。
在本实施例中,所述窄止位钩205实际功能与所述宽止位钩202相同,不同的是,所述窄止位钩205上未安装有所述悬臂件203,只起到限制所述防护罩主体201朝向远端径向移动的作用,但是这种设计充分利用了所述宽止位钩202之间的空余位置。
此外,所述宽止位钩202一般在所述防护罩主体201近端设置两个,所述窄止位钩205设置在所述宽止位钩202之间时,可以提供平衡力,即所述宽止位钩202与所述悬臂件203夹持所述针安装件1的最大外径处时,避免所述防护罩主体201晃动。
所述宽止位钩202对称设置。
所述窄止位钩205对称设置。
在本实施例中,所述宽止位钩202以及所述窄止位钩205对称设计,一方面使得所述防护罩单元2更为美观,另一方面使得卡合力保持平衡,减少所述防护罩主体201的晃动。
所述悬臂件203包括悬臂弹性件203a,以及悬臂卡合件203b,其中;
所述悬臂弹性件203a远端设置在所述悬臂口204内侧面上;
所述悬臂卡合件203b远端设置在所述悬臂弹性件203a近端上;
所述防护罩主体201关闭时,所述悬臂卡合件203b近端抵在所述针安装件1最大外径处近端一侧。
在本实施例中,所述悬臂件203由两个部分组成,第一部分为设置在所述悬臂安装口204上的悬臂弹性件203a,并朝向所述防护罩主体201径向弯曲,所述悬臂卡合件203b设置在所述悬臂弹性件203a末端的端面上,这样使得所述悬臂卡合件203b的端面可以与针安装件1的最大外径处的远端面顶在一起,并且用于在关闭时顶起所述针安装件1的最大外径处远端面,以及打开时对所述针筒主体A表面产生摩擦力限制作用。
所述悬臂件203还包括近端倒角203c;其中:
所述近端倒角203c设置在所述悬臂卡合件203b近端,在所述防护罩主体201打开时,使悬臂卡合件203b越过所述针安装件1的最大外径处。
在本实施例中,所述第一步轴向推动所述防护罩主体201时,所述近端倒角203c在轴向顶起所述针安装件1的最大外径处远端端面,会产生一个径向的力,带动所述悬臂弹性件203a径向扩张,从而越过所述针安装件1的最大外径处,使得所述防护罩主体201继续轴向移动。
所述悬臂件203还包括远端倒角203d;其中:
所述远端倒角203d设置在所述悬臂卡合件203b远端,在所述防护罩主体201关闭时,使所述悬臂卡合件203b越过所述针安装件1的最大外径处。
在本实施例中,所述第四步轴向推动所述防护罩主体201时,所述远端倒角203d在轴向顶起所述针安装件1的最大外径处近端端面,带动所述悬臂弹性件203a径向扩张,从而越过所述针安装件1的最大外径处,使得所述悬臂卡合件203b与所述针安装件1的最大外径处远端卡合。
所述针安装件1包括凸棱件101,其中:
在所述防护罩主体201关闭时,所述凸棱件101远端与所述悬臂卡合件203b卡合,所述凸棱件101近端与所述宽止位钩202和窄止位钩205卡合。
在本实施例中,所述凸棱件101即为所述针安装件1的最大外径处的一种表现形式,作用在于其远端与所述悬臂卡合件203b顶起,近端与所述宽止位钩202和窄止位钩205顶起,并且与所述注射针筒11形成一个环形凹槽,用于卡合所述宽止位钩202和窄止位钩205的近端卡合块。
此外,所述凸棱件101使得一旦卡死后,无论所述防护罩主体201如何旋转都不会与其脱离卡合状态。
所述针安装件1包括凸棱倒角102,其中:
所述凸棱倒角102设置在所述凸棱件101远端上,在所述防护罩主体201打开时,使所述悬臂卡合件203b越过所述凸棱件101。
在本实施例中,所述凸棱倒角102的倒角斜率与所述远端倒角203d相同,这样在第一步时,所述远端倒角203d与凸棱倒角102相抵,从而提高了所述悬臂弹性件203a的径向扩张力,便于所述悬臂件203越过所述凸棱件101。
一种针头防护式预灌封注射器的部件,还包括密封塞,以及插接设置在所述密封塞上的推动杆。
在本实施例中,所述密封塞后留有安装所述推动杆一端的卡合槽。
一种针头防护式预灌封注射器的部件的安装方法,包括以下步骤:
第一步:将所述针套单元3装入所述防护罩主体2中;
第二步:将所述防护罩主体2和针套单元3安装在所述针安装件1上;
第三步:将所述密封塞安装在所述注射针筒11中;
第四步:将所述推动杆安装在所述密封塞上。
在本实施例中,所述防护罩主体2和针套单元3一同安装的方式更为简便,便于应用在流水线式的安装过程中。
一种针头防护式预灌封注射器的部件的药品灌封方法,包括以下步骤:
1.将所述注射针筒11开口向上并垂直于水平面放置,并向所述注射针筒11中灌注定量液体药品;
2.将所述密封塞,通过套筒安装在所述注射针筒11中,所述套筒最大外径小于所述注射针筒最小内径;
3.将所述推动杆安装在所述密封塞上。
在本实施例中,所述密封塞安装在所述注射针筒11后,所述注射针筒11内不留有空气,操作人员可以直接进行注射。
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 (13)

  1. 一种针头防护式预灌封注射器,包括注射针筒(11),以及针头(12),其特征在于,还包括针安装件(1),防护罩单元(2)以及针套单元(3);其中:
    所述针头(12)安装在所述针安装件(1)上;
    所述针套单元(3)套接在所述针头(12)及部分所述针安装件(1)上;
    所述防护罩单元(2)套接在所述针套单元(3)及部分所述注射针筒(11)上;
    所述防护罩单元(2)包括防护罩主体(201),以及设置在所述防护罩主体(201)上的前卡合件;
    所述针安装件(1)设置在所述注射针筒(11)远端,并与所述注射针筒(11)之间形成凹槽用于卡合所述前卡合件。
  2. 根据权利要求1所述的一种针头防护式预灌封注射器,其特征在于,所述防护罩单元(2)还包括所述防护罩主体(201)上的后卡合件;其中:
    所述后卡合件近端轴向顶起所述针安装件(1)的最大外径处远端。
  3. 根据权利要求1所述的一种针头防护式预灌封注射器,其特征在于,所述防护罩单元(2)还包括宽止位钩(202);其中:
    所述宽止位钩(202)远端连接所述防护罩主体(201)近端,所述宽止位钩(202)近端卡合在所述凹槽中。
  4. 根据权利要求3所述的一种针头防护式预灌封注射器,其特征在于,所述防护罩单元(2)还包括悬臂件(203),以及悬臂口(204);其中:
    所述悬臂口(204)设置在所述宽止位钩(202)上;
    所述悬臂件(203)安装在所述悬臂口(204)内侧面上。
  5. 根据权利要求4所述的一种针头防护式预灌封注射器,其特征在于,所述悬臂口(204)向远端延伸至部分所述防护罩主体(201)上。
  6. 根据权利要求3所述的一种针头防护式预灌封注射器,其特征在于,所述防护罩单元(2)还包括窄止位钩(205);其中:
    所述窄止位钩(205)远端连接所述防护罩主体(201)近端,所述窄止位钩(205)近端与所述针安装件(1)最大外径处近端一侧卡合;
    所述窄止位钩(205)设置在两个所述宽止位钩(202)之间。
  7. 根据权利要求3所述的一种针头防护式预灌封注射器,其特征在于,所述宽止位钩(202)对称设置。
  8. 根据权利要求6所述的一种针头防护式预灌封注射器,其特征在于,所述窄止位钩(205)对称设置。
  9. 根据权利要求4所述的一种针头防护式预灌封注射器,其特征在于,所述悬臂件(203)包括悬臂弹性件(203a),以及悬臂卡合件(203b);其中;
    所述悬臂弹性件(203a)远端设置在所述悬臂口(204)内侧面上;
    所述悬臂卡合件(203b)远端设置在所述悬臂弹性件(203a)近端上;
    所述防护罩主体(201)关闭时,所述悬臂卡合件(203b)近端抵在所述针安装件(1)最大外径处近端一侧。
  10. 根据权利要求9所述的一种针头防护式预灌封注射器,其特征在于,所述悬臂件(203)还包括近端倒角(203c);其中:
    所述近端倒角(203c)设置在所述悬臂卡合件(203b)近端,在所述防护罩主体(201)打开时,使悬臂卡合件(203b)越过所述针安装件(1)的最大外径处。
  11. 根据权利要求9所述的一种针头防护式预灌封注射器,其特征在于,所述悬臂件(203)还包括远端倒角(203d);其中:
    所述远端倒角(203d)设置在所述悬臂卡合件(203b)远端,在所述防护罩主体(201)关闭时,使所述悬臂卡合件(203b)越过所述针安装件(1)的最大外径处。
  12. 根据权利要求9所述的一种针头防护式预灌封注射器,其特征在于,所述针安装件(1)包括凸棱件(101);其中:
    在所述防护罩主体(201)关闭时,所述凸棱件(101)远端与所述悬臂卡合件(203b)卡合,所述凸棱件(101)近端与所述宽止位钩(202)和窄止位钩(205)卡合。
  13. 根据权利要求9所述的一种针头防护式预灌封注射器,其特征在于,所述针安装件(1)包括凸棱倒角(102);其中:
    所述凸棱倒角(102)设置在所述凸棱件(101)远端上,在所述防护罩主体(201)打开时,使所述悬臂卡合件(203b)越过所述凸棱件(101)。
PCT/CN2023/070631 2022-03-21 2023-01-05 一种针头防护式预灌封注射器 WO2023179179A1 (zh)

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CN114796728A (zh) * 2022-05-07 2022-07-29 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、使用方法
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

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