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CN107773813B - Prefilled preparation of erythropoietin injection with safety protection device - Google Patents

Prefilled preparation of erythropoietin injection with safety protection device Download PDF

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Publication number
CN107773813B
CN107773813B CN201610786780.6A CN201610786780A CN107773813B CN 107773813 B CN107773813 B CN 107773813B CN 201610786780 A CN201610786780 A CN 201610786780A CN 107773813 B CN107773813 B CN 107773813B
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CN
China
Prior art keywords
needle
inner cylinder
needle tube
cylinder
protection device
Prior art date
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Application number
CN201610786780.6A
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Chinese (zh)
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CN107773813A (en
Inventor
周永春
厉颖
戴素霞
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 CHEMO WANBANG BIOPHARMA CO Ltd
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SHANGHAI CHEMO WANBANG BIOPHARMA CO Ltd
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Priority to CN201610786780.6A priority Critical patent/CN107773813B/en
Publication of CN107773813A publication Critical patent/CN107773813A/en
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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
    • A61M5/3129Syringe barrels
    • A61M5/3134Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
    • 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
    • A61M5/3257Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention relates to the field of medical equipment, in particular to a prefilled preparation of an erythropoietin injection with a safety protection device. The invention firstly provides a prefilled syringe with a safety protection device, which comprises the safety protection device, wherein the safety protection device comprises an outer cylinder and a first inner cylinder sleeved in the outer cylinder, the first inner cylinder is movably sleeved outside a needle tube through an elastic part, the rear end of the outer cylinder is provided with a needle tube flange displacement limiting part, the first inner cylinder comprises a needle head protecting part, and the outer wall of the first inner cylinder and the inner wall of the outer cylinder are correspondingly provided with a first limiting component for preventing the rear end of the first inner cylinder from falling out of the outer cylinder and a second limiting component for preventing the front end of the first inner cylinder from moving towards the needle head. When the needle tube of the prefilled syringe is prefilled with the erythropoietin liquid medicine, the prefilled preparation of the erythropoietin injection with the safety protection device is formed. The invention can pop out after injection is completed by arranging the safety protection device, thereby protecting the needle from hurting medical staff and patients.

Description

Prefilled preparation of erythropoietin injection with safety protection device
Technical Field
The invention relates to the field of medical equipment, in particular to a prefilled preparation of an erythropoietin injection with a safety protection device.
Background
At present, the erythropoietin products in the domestic medicine market comprise two dosage forms of injection and freeze-dried powder injection, and are packaged by a penicillin bottle or pre-filled package, and when the penicillin bottle is used, the packaging needs to be opened firstly and then the product is sucked by a syringe, so that secondary pollution is easily caused. The dead space at the joint of the needle head and the needle tube of the injector is easy to generate liquid medicine residue, and the usage amount is inaccurate. In addition, the common needle has large subcutaneous injection area, so that the pain of patients is increased. Similarly, the powder injection needs to be added with liquid for re-dissolution and then used, and the same problems can be caused.
The prefilled syringe is an inner package taking the prefilled syringe as a product, and is characterized in that the injected medicine is directly filled in the prefilled needle tube, and the needle tube is provided with an injection needle, so that the syringe and the medicine liquid packaging container are combined into a whole, and the prefilled syringe is directly injected when in use, thereby being very convenient. As an inner packing material directly contacting with the medicine, the prefilled syringe is safer and more convenient compared with the traditional packing material (penicillin bottle or ampoule package).
However, the prefilled syringes in the market at present are not provided with safety protection devices, and the needle heads of the prefilled syringes are easy to stab medical staff and patients, so that the infection risk is high.
Disclosure of Invention
In view of the above-mentioned drawbacks of the prior art, the present invention aims to provide a prefilled preparation of an erythropoietin injection with a safety device. The safety protection device can pop out after the injection is finished, and the needle is protected from hurting medical staff and patients.
In order to achieve the above object and other related objects, the present invention adopts the following technical scheme:
The invention provides a prefilled syringe with a safety protection device, which comprises a needle tube, a piston, a needle head protective cap and a push rod, wherein the needle tube is an open hollow cylinder, the needle head is fixed on a cone head at the front end of the needle tube, the needle head is sleeved with the needle head protective cap, a sealing rubber plug matched with the needle head is arranged in the needle head protective cap, the piston is arranged in the needle tube and connected with the push rod, and the rear end of the needle tube is provided with a needle tube flange; the prefilled syringe still includes safety device, safety device includes urceolus and the first inner tube of cover in locating the urceolus, first inner tube is established through elastic component movable sleeve outside the needle tubing, the rear end of urceolus is equipped with needle tubing flange displacement limiting part, first inner tube includes syringe needle protection part, and the outer wall of first inner tube and the inner wall of urceolus correspond and are equipped with the first spacing subassembly that prevents that first inner tube rear end from deviating from the urceolus and stop the second spacing subassembly that first inner tube front end was toward syringe needle direction motion.
Preferably, the first limiting component comprises a first limiting part arranged on the outer wall of the first inner cylinder, and a second limiting part protruding inwards is arranged on the inner wall of the outer cylinder.
Preferably, the first limiting parts are provided in plurality and are uniformly distributed along the circumferential direction.
Preferably, the second limiting assembly comprises a first clamping part and a second clamping part, the first clamping part is arranged on the outer wall of the first inner cylinder and protrudes outwards, the second clamping part is positioned at the front end of the outer cylinder, and the first clamping part is in elastic contact with the second clamping part.
Preferably, the second clamping part is provided with a plurality of grooves, and the plurality of grooves are distributed along the circumferential direction.
Preferably, the prefilled syringe is a spring, and the spring surrounds the outer wall of the first inner cylinder.
Preferably, a second inner cylinder is arranged in the outer cylinder and is fixed on the needle tube flange displacement limiting component, a clamping groove is arranged in the second inner cylinder, and one end of the elastic component is fixed on the clamping groove.
Preferably, a fixing frame is arranged at the rear end of the outer cylinder, the fixing frame is fixed on the needle tube flange displacement limiting component, and the flange is positioned between the fixing frame and the needle tube flange displacement limiting component.
Preferably, the diameter of the needle head is 0.2-0.5 mm, and the needle tip of the needle head is double inclined plane, triple inclined plane or five inclined planes.
Preferably, the needle tube volume is 1ml, 2ml, 2.25ml, 2.5ml, 3ml or 5ml.
Preferably, the outer surface of the needle head protective cap is provided with anti-skid patterns.
Preferably, the needle tube of the prefilled syringe is prefilled with an erythropoietin liquid medicine, wherein the erythropoietin liquid medicine is selected from recombinant human erythropoietin, recombinant human erythropoietin-hybrid Fc fusion protein, recombinant human erythropoietin-Fc fusion protein, recombinant human erythropoietin, polyethylene glycol recombinant human erythropoietin or carbamylated derivatives of recombinant human erythropoietin, and the prefilled preparation of the erythropoietin injection with the safety protection device is formed.
As described above, the prefilled syringe and the prefilled preparation of the erythropoietin injection with the safety protection device according to the present invention have the following beneficial effects: the medical care use is extremely convenient, the suction is not needed, the needle head is not needed to be installed, and the injection cost of a patient is reduced;
1. Avoiding the generation of rubber plug scraps caused by repeated suction after the diluent is used, and reducing the residual and secondary pollution opportunities;
2. the design of no dead space can be fully utilized, no residual liquid medicine exists, and the dosage is more accurate;
3. The unit dose is small in volume, and the swelling pain is light during injection;
4. the needle is sharp, the operation is convenient, and the pricking sensation is reduced;
5. disposable, direct injection, pollution risk reduction and patient medication safety improvement;
6. After the injection is completed, the safety device is manually activated, and after the inner cylinder is ejected, the injection needle is completely sleeved, so that medical staff can be effectively protected from the risk of needle penetration infection.
Drawings
FIG. 1 is a schematic diagram of the structure of the present invention when not excited.
FIG. 2 is a schematic diagram of the structure of the present invention after excitation.
Fig. 3 is a schematic plan view of the second clamping portion.
Description of element reference numerals
10. Needle tube
11. Piston
12. Needle head
13. Needle protective cap
14. Push rod
15. Needle tube flange
20. Safety protection device
30. Outer cylinder
31. Needle tube flange displacement limiting member
311. Through hole
32. Second limit part
33. Fixing frame
40. First inner cylinder
400. Needle protecting part
41. First limit part
42. First clamping part
43. Second clamping part
431. Groove
50. Elastic component
60. Second inner cylinder
61. Clamping groove
Detailed Description
Further advantages and effects of the present invention will become apparent to those skilled in the art from the disclosure of the present invention, which is described by the following specific examples.
It should be understood that the structures, proportions, sizes, etc. shown in the drawings are for illustration purposes only and should not be construed as limiting the invention to the extent that it can be practiced, since modifications, changes in the proportions, or otherwise, used in the practice of the invention, are not intended to be critical to the essential characteristics of the invention, but are otherwise, required to achieve the objective and effect taught by the invention. Also, the terms such as "upper", "lower", "left", "right", "middle", and the like are used herein for descriptive purposes only and are not intended to limit the scope of the invention for which the invention may be practiced or for which the relative relationships may be altered or modified without materially altering the technical context.
As shown in fig. 1 and 2, the invention provides a prefilled syringe with a safety protection device, which comprises a needle tube 10, a piston 11, a needle head 12, a needle head protective cap 13 and a push rod 14, wherein the needle tube 10 is an open hollow cylinder, the needle head 12 is fixed on a cone head at the front end of the needle tube 10, the needle head 12 is detachably sleeved with the needle head protective cap 13, a sealing rubber plug matched with the needle head 12 is arranged in the needle head protective cap 13, the needle tube is internally provided with the piston 11 as a sealing cover of liquid medicine in the needle tube, the piston 11 can slide and seal in the needle tube, the piston 11 is connected with the push rod 14, the push rod 14 is provided with a section which is inserted into the needle tube and can drive the piston 11 to move in the needle tube, and the rear end of the needle tube 10 is provided with a needle tube flange 15.
As shown in fig. 1 to 3, the prefilled syringe further includes a safety device 20, the safety device includes an outer cylinder 30 and a first inner cylinder 40 sleeved in the outer cylinder 30, the first inner cylinder 40 is movably sleeved outside the needle tube 10 via an elastic member 50, a needle tube flange displacement limiting member 31 is disposed at the rear end of the outer cylinder 30, a through hole 311 is disposed on the needle tube flange displacement limiting member 31, and the needle tube flange displacement limiting member 31 can be used to block the needle tube flange 15 and prevent the needle tube flange 15 from entering the outer cylinder 30. The first inner barrel 40 comprises a needle head protection part 400, when the first inner barrel 40 pops up, the needle head protection part 400 is sleeved on the periphery of the needle head 12, a first limiting component for preventing the rear end of the first inner barrel from falling out of the outer barrel and a second limiting component for preventing the front end of the first inner barrel 40 from moving towards the needle head direction are correspondingly arranged on the outer wall of the first inner barrel 40 and the inner wall of the outer barrel 30, and the first limiting component ensures that the first inner barrel 40 cannot leave the outer barrel 30 when popping up. When not excited, the rear end of the first inner cylinder 40 passes through the through hole 311 to be in contact with the needle tube flange 15, the front end is in elastic contact with the outer cylinder 30, the front end of the outer cylinder 30 is clamped with the first inner cylinder 40 through elastic force, and the second limiting assembly ensures that the first inner cylinder 40 cannot move forwards under the condition of no external acting force. The elastic member 50 is positioned between the first inner cylinder 40 and the outer cylinder 30, and the elastic member 50 applies an elastic force to the first stopper 41 so that the first inner cylinder 40 receives a forward force, but since the force is smaller than the force by which the front end of the outer cylinder 30 binds the first inner cylinder 40, the first inner cylinder 40 does not move forward without an external pushing force.
Preferably, the first limiting component comprises a first limiting part 41 arranged on the outer wall of the first inner cylinder 40, and a second limiting part 32 protruding inwards is arranged on the inner wall of the outer cylinder 30. Preferably, the first limiting portions 41 are provided in plurality and are uniformly arranged along the circumferential direction. After the excitation of the present invention, the first limiting part 41 moves to the front end of the outer cylinder 30, and at this time, the second limiting part 32 at the rear end can clamp the first limiting part 41, preventing the first inner cylinder 40 from moving backward, and further ensuring the safety of use. Preferably, the elastic member 50 is a spring, and the spring surrounds the outer wall of the first inner cylinder 40. Preferably, a second inner cylinder 60 is provided in the outer cylinder 30, the second inner cylinder 60 is fixed to the syringe flange displacement restricting member 31, a locking groove 61 is provided in the second inner cylinder 60, and one end of the elastic member 60 is fixed to the locking groove 61.
As shown in fig. 1 to 3, preferably, the second limiting assembly includes a first clamping portion 42 provided on an outer wall of the first inner cylinder 40 to protrude outward, and a second clamping portion 43 provided at a front end of the outer cylinder 30, and the first clamping portion 42 is elastically contacted with the second clamping portion 43. The second clamping part 43 of the prefilled syringe elastically clamps the first clamping part 42, so that the first inner cylinder 40 is prevented from being ejected when not excited, when the invention is excited, the experimenter forcefully pushes the push rod 14 forward, the needle tube flange 15 pushes the first inner cylinder 40 forward, the first clamping part 42 is separated from the elastic constraint of the second clamping part 43, and the first inner cylinder 40 is ejected forward under the elastic action of the elastic component 50. Preferably, the second clamping portion 43 is provided with a plurality of grooves 431, and the plurality of grooves 431 are distributed along the circumferential direction, so as to ensure that the first inner cylinder 40 can be ejected smoothly.
Preferably, a fixing frame 33 is provided at the rear end of the outer cylinder 30, the fixing frame 33 is fixed to the needle tube flange displacement limiting member 31, and the needle tube flange 15 is located between the fixing frame 33 and the needle tube flange displacement limiting member 31. Preferably, the diameter of the needle 12 is 0.2-0.5 mm, the tip of the needle is the thinnest, sharpest, double bevel, triple bevel or pentabevel, and the patient has only a slight feel when injecting. Preferably, the needle tube is made of borosilicate glass material, the piston is made of butyl rubber material, and the material is selected to reduce the adsorption of liquid medicine. Preferably, the needle cannula 10 has a volume of 1ml, 2ml, 2.25ml, 2.5ml, 3ml or 5ml, and new gauges may be added depending on medical and marketing requirements. Because of different clinical recommended usage amounts of various liquid medicines and also because of different usage amounts of individual differences of patients, the specifications of the prefilled syringe of the erythropoietin medicines can be various.
After the prefilled syringe is sterilized and detected, different prefilled syringes are respectively filled with recombinant human erythropoietin injection, recombinant human erythropoietin-hybrid Fc fusion protein, recombinant human erythropoietin-Fc fusion protein, recombinant human erythropoietin, PEGylated recombinant human erythropoietin injection and carbamylated derivative injection of recombinant human erythropoietin into a cavity surrounded by a needle tube, a cone head and a piston under the condition of local hundred grades, and after each liquid medicine is respectively filled with 1000IU,2000IU,3000IU,4000IU,5000IU,6000IU,10000IU,20000IU,40000IU,0.1mg,0.2mg,0.3mg,0.4mg,0.5mg,0.6mg,1.0mg,1.5mg,, the whole prefilled syringe is filled into a safety device, and then is packaged by aluminum foil or a bubble cap to form the prefilled preparation of the erythropoietin injection with the safety device. The filling, the light inspection, the labeling, the rod screwing, the loading into the safety device and the plastic packaging of the pre-filled preparation of the erythropoietin injection with the safety protection device are all completed by adopting an automatic production line.
Through trial production, the prefilled syringe with the safety protection device and the prefilled preparation of the erythropoietin injection with the safety protection device are convenient to use, can effectively reduce the risk of clinical infection, and have good clinical application prospect.
In summary, the present invention effectively overcomes the disadvantages of the prior art and has high industrial utility value.
The above embodiments are merely illustrative of the principles of the present invention and its effectiveness, and are not intended to limit the invention. Modifications and variations may be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the invention. Accordingly, it is intended that all equivalent modifications and variations of the invention be covered by the claims, which are within the ordinary skill of the art, be within the spirit and scope of the present disclosure.

Claims (7)

1. The prefilled syringe with the safety protection device comprises a needle tube (10), a piston (11), a needle head (12), a needle head protective cap (13) and a push rod (14), wherein the needle tube (10) is an open hollow cylinder, the needle head (12) is fixed on a cone head at the front end of the needle tube (10), the needle head (12) is sleeved with the needle head protective cap (13), a sealing rubber plug matched with the needle head (12) is arranged in the needle head protective cap (13), the piston (11) is arranged in the needle tube (10), and the piston (11) is connected with the push rod (14), and is characterized in that a needle tube flange (15) is arranged at the rear end of the needle tube (10); the pre-filled syringe further comprises a safety protection device (20), the safety protection device comprises an outer cylinder (30) and a first inner cylinder (40) sleeved in the outer cylinder (30), the first inner cylinder (40) is movably sleeved outside the needle tube (10) through an elastic component (50), the rear end of the outer cylinder (30) is provided with a needle tube flange displacement limiting component (31), the first inner cylinder comprises a needle head protection part (400), the outer wall of the first inner cylinder (40) and the inner wall of the outer cylinder (30) are correspondingly provided with a first limiting component for preventing the rear end of the first inner cylinder from falling out of the outer cylinder and a second limiting component for blocking the front end of the first inner cylinder (40) from moving towards the needle head direction, the first limiting component comprises a first limiting part (41) arranged on the outer wall of the first inner cylinder (40), the inner wall of the outer cylinder (30) is provided with a second limiting part (32) protruding inwards, the second limiting component comprises a first inner cylinder part (42) arranged on the outer wall of the first inner cylinder (40) and a second clamping part (43) arranged at the front end of the first inner cylinder (30), and the second limiting component is in contact with the first clamping part (43); the elastic component (50) is a spring, and the spring surrounds the outer wall of the first inner cylinder (40).
2. The prefilled syringe with safety shield of claim 1, wherein: the first limiting parts (41) are arranged in a plurality and are uniformly distributed along the circumferential direction.
3. The prefilled syringe with safety shield of claim 1, wherein: the second clamping part (43) is provided with a plurality of grooves (431), and the grooves (431) are distributed along the circumferential direction.
4. The prefilled syringe with safety shield of claim 1, wherein: the outer cylinder (30) is internally provided with a second inner cylinder (60), the second inner cylinder (60) is fixed on the needle tube flange displacement limiting component (31), the second inner cylinder (60) is internally provided with a clamping groove (61), and one end of the elastic component (50) is fixed on the clamping groove (61).
5. The prefilled syringe with safety shield of claim 1, wherein: the rear end of the outer cylinder (30) is provided with a fixing frame (33), the fixing frame (33) is fixed on the needle tube flange displacement limiting component (31), and the needle tube flange (15) is positioned between the fixing frame (33) and the needle tube flange displacement limiting component (31).
6. The prefilled syringe with safety shield of claim 1, wherein: further comprising any one or more of the following features: 1) The diameter of the needle head (12) is 0.2-0.5 mm, and the needle tip of the needle head is double inclined planes, triple inclined planes or five inclined planes; 2) The volume of the needle tube (10) is 1ml, 2ml, 2.25ml, 2.5ml, 3ml or 5ml; 3) The outer surface of the needle head protective cap (13) is provided with anti-skid patterns.
7. The prefilled syringe with safety shield of claim 1, wherein: the needle tube (10) of the prefilled syringe is prefilled with an erythropoietin liquid medicine, wherein the erythropoietin liquid medicine is selected from recombinant human erythropoietin, recombinant human erythropoietin-hybrid Fc fusion protein, recombinant human erythropoietin-Fc fusion protein, recombinant human erythropoietin, PEGylated recombinant human erythropoietin or carbamylated derivatives of recombinant human erythropoietin.
CN201610786780.6A 2016-08-31 2016-08-31 Prefilled preparation of erythropoietin injection with safety protection device Active CN107773813B (en)

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CN107773813B true CN107773813B (en) 2024-08-30

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CN109364334A (en) * 2018-09-28 2019-02-22 黄桂庭 A kind of syringe
CN111888581A (en) * 2020-09-10 2020-11-06 苏州赛卫生物科技有限公司 Safety syringe with needle protector
CN113082379A (en) * 2021-03-26 2021-07-09 江苏盛泽医院 Integrated injector suitable for infectious vaccine injection
CN117414503A (en) * 2023-08-28 2024-01-19 梵颖(上海)生物科技有限公司 A syringe protection device and safety syringe

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CN101879342A (en) * 2009-05-05 2010-11-10 萨克哈拉姆·D·马赫卡 Universal safety syringe
CN104027875A (en) * 2009-05-05 2014-09-10 萨克哈拉姆·D·马赫卡 Universal safety syringe
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