WO2018086192A1 - 一种安全注射针 - Google Patents

一种安全注射针 Download PDF

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Publication number
WO2018086192A1
WO2018086192A1 PCT/CN2016/110122 CN2016110122W WO2018086192A1 WO 2018086192 A1 WO2018086192 A1 WO 2018086192A1 CN 2016110122 W CN2016110122 W CN 2016110122W WO 2018086192 A1 WO2018086192 A1 WO 2018086192A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
safety
sheath
hook
buckle
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/CN2016/110122
Other languages
English (en)
French (fr)
Inventor
王兴国
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.)
Berpu Medical Technology Co Ltd
Original Assignee
Berpu Medical Technology Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Berpu Medical Technology Co Ltd filed Critical Berpu Medical Technology Co Ltd
Priority to ES16921192T priority Critical patent/ES2930851T3/es
Priority to RU2019118213A priority patent/RU2729549C1/ru
Priority to KR1020197014505A priority patent/KR20190080895A/ko
Priority to BR112019009528-4A priority patent/BR112019009528B1/pt
Priority to US16/349,285 priority patent/US11033213B2/en
Priority to EP16921192.7A priority patent/EP3539598B1/en
Priority to CA3046821A priority patent/CA3046821C/en
Publication of WO2018086192A1 publication Critical patent/WO2018086192A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150541Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150572Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150664Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
    • A61B5/150671Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element comprising means to impede repositioning of protection sleeve from covering to uncovering position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150732Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • 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
    • A61M5/3216Caps placed transversally onto the needle, e.g. pivotally attached to the needle base
    • 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
    • A61M5/3216Caps placed transversally onto the needle, e.g. pivotally attached to the needle base
    • A61M2005/3217Means to impede repositioning of protection cap from needle covering to needle uncovering position, e.g. catch mechanisms

Definitions

  • the present invention relates to the technical field of medical devices, and more particularly to a safety injection needle.
  • a safe blood collection needle including a needle seat and a needle through the needle a double-ended needle tube having a venous puncture needle at one end and a cannula needle at the other end, wherein the safety lancet further comprises a safety sheath, a connecting mechanism and a card seat.
  • the card holder is fixed on the needle seat, the safety sheath is connected to the card seat by a connecting mechanism, and the safety sheath can be rotated around a connecting mechanism, wherein the safety sheath is a hollow cavity body, At least one needle safety hook is provided in the cavity.
  • the safety sheath is a barrel, and a side of the side wall of the safety sheath facing the needle is provided with an opening, the length of the opening being greater than the length of the needle, the side of the safety sheath Positions on both sides of the opening on the wall respectively form a protective flap, and the two protective flaps are oppositely disposed.
  • the safety sheath is provided with two needle safety hooks, and the hook body root of the needle safety hook is located on the inner side wall of the safety sheath between the two protection fins, and the bending point of the needle safety hook body Forming an acute angle of the inner side wall of the safety sheath between the two protective flaps, the hooks of the two needle safety hooks are opposite in direction, and the needle safety hook can be hooked on the needle tube.
  • the safety sheath is provided with two sheath buckles, the sheath buckle is a protruding block, the two jacket buckles are oppositely positioned, and the sheath buckle is disposed on the protection flap.
  • the card holder On the inner side wall, the card holder is provided with two bayonet ports corresponding to the shape of the sheath buckle, and the sheath clip can be stuck on the bayonet.
  • the card seat is a ring and is sleeved on an outer surface of the needle seat, and the ring has a size and a shape corresponding to the outer side of the needle seat.
  • the card seat is a hollow cavity, and is sleeved on an outer surface of the needle seat, and the cavity has a size and a shape corresponding to the needle seat.
  • the sheath snap is disposed on an inner side wall of the safety sheath adjacent to the attachment mechanism.
  • the connecting mechanism includes a fold The mechanism and an elastic mechanism, the two ends of the elastic mechanism are respectively connected to two ends of the folding mechanism, and the elastic mechanism is located directly below the folding mechanism.
  • the venipuncture needle is externally provided with a puncture needle cap, and the puncture needle cap is stuck on the needle seat;
  • the cannula needle is externally provided with a cannula needle cap, and the cannula needle cap is stuck on the needle seat on.
  • a safety syringe including a cylinder and a needle
  • the needle The utility model comprises a needle seat and a needle tube, characterized in that the safety syringe further comprises a safety sheath, a connecting mechanism and a card seat, the card seat is fixed on the needle seat, and the safety sheath is connected
  • the mechanism is coupled to the card holder, and the safety sheath is rotatable about a connection mechanism.
  • the safety sheath is a hollow cavity body, and at least one needle safety hook is disposed in the cavity.
  • the safety sheath is a barrel, and a side of the side wall of the safety sheath facing the needle is provided with an opening, the length of the opening being greater than the length of the needle, the side of the safety sheath Positions on both sides of the opening on the wall respectively form a protective flap, and the two protective flaps are oppositely disposed.
  • the safety sheath is provided with two needle safety hooks, and the hook body root of the needle safety hook is located on the inner side wall of the safety sheath between the two protection fins, and the bending point of the needle safety hook body Forming an acute angle of the inner side wall of the safety sheath between the two protective flaps, the hooks of the two needle safety hooks are opposite in direction, and the needle safety hook can be hooked on the needle tube.
  • the safety sheath is provided with two sheath buckles, the sheath buckle is a protruding block, the two jacket buckles are oppositely positioned, and the sheath buckle is disposed on the protection flap.
  • the card holder On the inner side wall, the card holder is provided with two bayonet ports corresponding to the shape of the sheath buckle, and the sheath clip can be stuck on the bayonet.
  • the card seat is a ring and is sleeved on an outer surface of the needle seat, and the ring has a size and a shape corresponding to a lower portion of the needle seat.
  • the card seat is a hollow cavity, and is sleeved on an outer surface of the needle seat, and the cavity has a size and a shape corresponding to the needle seat.
  • the sheath snap is disposed on an inner side wall of the safety sheath adjacent to the attachment mechanism.
  • the connecting mechanism includes a folding mechanism and an elastic mechanism. Two ends of the elastic mechanism are respectively connected to two ends of the folding mechanism, and the elastic mechanism is located directly below the folding mechanism.
  • a needle cap is disposed outside the needle, and the bottom of the needle cap is sleeved on the card seat.
  • the existing safety injection needles adopt a lateral safety sheath structure, and the safety sheath is provided with a hook body matched with the injection needle tube, and the engagement of the hook body and the needle tube is realized.
  • the safety sheath and the needle tube are relatively fixed, and the needle tube is hidden in the safety sheath, so that the safety of the injection needle is finally realized, and the accidental stab wound accident is effectively avoided.
  • the safety injection needles described in the prior art still have many problems in the use process.
  • 1. When the safety sheath is buckled, a large force must be used, and the medical personnel operate when the clinical mass is used. Difficult; 2, the hook structure and the needle tube have certain defects, when subjected to a certain degree of external force, the two are prone to detachment, stability and safety are not ideal; 3, when the safety sheath and After the needle tube is engaged, the needle tube remains in a straight state, the bite strength between the hook body and the needle tube is not large, and there is room for movement of the needle tube in the hook body, resulting in poor stability of the needle tube locking structure; 4. convenient for use after use.
  • the needle tip is locked in the safety cover, and many patents additionally increase the buckled parts or change the ordinary needle holder, because the use of the disposable product is very large, resulting in waste of plastic and increased production cost.
  • the elastic root When the button is inserted, the elastic root is snapped open and the hand feel is very easy. After testing, the required thrust is about 0.5N. It can be operated comfortably with one hand during clinical use. If the safety cover is to be opened after the buckle, the buckle is buckled.
  • the elastic root is inclined with the direction of the force of the needle hook component, which generates a strong tensile force, and it is difficult to open the safety cover, thereby overcoming the shortcomings and deficiencies in the prior art.
  • a safety injection needle comprising an injection needle, the injection needle being composed of a needle holder and a needle tube, the needle holder being connected to the safety protection sleeve by a flexible folding mechanism, Two symmetrically distributed needle seat hooks are arranged on the side wall of the needle seat, the safety cover is safe
  • the protective sleeve has a long strip structure, the inner cavity of the safety protective sleeve is hollow, the lower end of the safety protective sleeve is connected with one end of the elastic folding mechanism, and the other end of the elastic folding mechanism is fixedly connected with the side wall of the needle seat.
  • the upper end of the safety cover is suspended, and the safety cover is turned over with the folding of the elastic folding mechanism.
  • the safety protection sleeve forms an opening near the side of the needle tube, and the other side of the safety protection sleeve is opposite to the opening.
  • two symmetrically distributed sheath buckles with elastic roots are arranged, and the two sheath buckles cooperate with the two needle seat hooks, and the sheath buckles
  • a jacket snap stop is provided on the outside.
  • the invention discloses a safety injection needle, which adopts a double needle seat hook structure disposed on the side wall of the needle seat, and cooperates with a double sheath buckle provided in the inner cavity of the safety protection sleeve, and the sheath buckle and the needle seat hook
  • the clamping process is light and convenient, and the required thrust is only about 0.5N, which can realize one-hand operation.
  • the outer side of the sheath buckle is also provided with a sheath buckle block, which can effectively prevent the sheath buckle and the needle holder from being caught. Loose.
  • the needle seat portion of the patent technology still uses the design structure of the conventional conventional needle seat, and only the needle seat hook is added, the structure can be formed at one time, and the volume of the needle seat is not required to increase the safety buckle function or one is added. It can catch other components of the helmet, effectively control the cost, save materials, and realize the safe operation of the product simply and effectively.
  • another advantage of using the conventional needle holder is that the position of the needle seat is smaller and the product is assembled. One tooling can assemble more products at a time, and the production efficiency is higher.
  • the overall design of the product is ingeniously realized with various functions, and the stability and safety can achieve the desired effect.
  • Figure 1 is a schematic view showing the structure of a safety injection needle of the present invention.
  • Figure 2 is a perspective view of a safety injection needle of the present invention.
  • Fig. 3 is a view showing the first use state of the safety injection needle of the present invention.
  • Fig. 4 is a view showing the second use state of the safety injection needle of the present invention.
  • Fig. 5 is a view showing a third use state of the safety injection needle of the present invention.
  • Figure 6 is a schematic view showing the locked state of the injection needle and the safety protective cover of the present invention.
  • Figure 7 is a schematic view showing the structure of a first embodiment of the present invention.
  • Figure 8 is a perspective view of a first embodiment of the present invention.
  • Figure 9 is a first use state diagram of the first embodiment of the present invention.
  • Figure 10 is a second use state diagram of the first embodiment of the present invention.
  • Figure 11 is a third use state diagram of the first embodiment of the present invention.
  • FIG. 12 is a schematic view showing the locked state of the injection needle and the safety protection cover according to the first embodiment of the present invention.
  • Figure 13 is a schematic view showing the structure of a second embodiment of the present invention.
  • Figure 14 is a perspective view of a second embodiment of the present invention.
  • Figure 15 is a first use state diagram of a second embodiment of the present invention.
  • Figure 16 is a second use state diagram of the second embodiment of the present invention.
  • Figure 17 is a view showing a third use state of the second embodiment of the present invention.
  • Figure 18 is a schematic view showing the locked state of the injection needle and the safety protective cover according to the second embodiment of the present invention.
  • FIG. 19 is a first schematic view showing the first state of the process of fitting the socket hook and the sheath buckle according to the present invention.
  • FIG. 20 is a schematic view showing the second state of the process of fitting the socket hook and the sheath buckle according to the present invention.
  • FIG. 21 is a schematic view showing the third state of the process of fitting the socket hook and the sheath buckle according to the present invention.
  • FIG. 22 is a fourth schematic view showing the process of fitting the socket hook and the sheath buckle according to the present invention.
  • the invention discloses a safety injection needle, as shown in FIG. 1 and FIG. 2, which comprises an injection needle 1 which is composed of a needle holder 101 and a needle tube 102, which is different from the prior art in that the needle
  • the seat 101 is connected to the safety cover 2 through a flexible folding mechanism 4.
  • the side wall of the needle holder 101 is provided with two symmetrically distributed needle holders 103.
  • the safety cover 2 has a long strip structure and is safe.
  • the inner cavity of the protective cover 2 is hollow, and the lower end of the protective cover 2 is connected to one end of the elastic folding mechanism 4, and the other end of the elastic folding mechanism 4 is fixedly connected with the side wall of the needle holder 101, and the safety cover 2 is The upper end is suspended, and the safety cover 2 is turned over with the folding of the elastic folding mechanism 4, and the opening of the safety protection sleeve 2 near the needle tube 102 forms an opening 201, and the other side of the safety protection sleeve 2 opposite to the opening 201 is Form a closed surface 202, the hollow inner cavity of the safety protective sleeve 2 is provided with two symmetrically distributed sheath buckles 203, and the buckle 203 has a root portion 2031 which can be bounced (no other materials are needed, only the part needs to be made)
  • the two sheath buckles 203 are matched with the two needle seat hooks 103, and the outer side of the sheath buckles 203 are provided with a sheath buckle. Stop 204.
  • the upper end portion of the needle holder hook 103 is formed with a hook end 1031 bent toward one side
  • the sheath buckle 203 is composed of an elastic root portion 2031 and a buckle end portion 2030, and the sheath buckle 203
  • the buckle end 2030 forms a bend of the closing surface 202
  • the initial contact point of the needle hook 103 and the sheath buckle 203 is a bend of the hook end and a bend of the buckle end 2030, and the hook The end is opposite to the direction in which the buckle end 2030 is bent.
  • the structural design can ensure that when the needle seat hook 103 and the sheath buckle 203 are in initial contact, the touch surfaces of the two are curved surfaces of two arcs, or one of them is a curved surface of a circular arc, the purpose is to The thrust that triggers the occlusion of both is minimized.
  • the sheath buckle 203 has an elastic root portion 2031.
  • the needle seat hook 103 is pressed against the sheath buckle 203, and the elastic root portion 2031 is inclined in the direction of the top of the needle holder hook 103 (direction A in FIG. 20).
  • the sheath buckle 203 rebounds in the direction of FIG. 21 and is buckled into the needle holder 103.
  • the force of the buckle is verified by experiments to be only about 0.5N. This technical feature is currently not possible with similar products on the market. (Partial enlargement is shown in Figure 19- Figure 21)
  • the hook 103 pulls the buckle 203 in the direction of FIG. 22, and the elastic root of the buckle 203 is inclined in the direction of C.
  • the safety sheath and the needle seat are The opening force becomes: 1.
  • the force of the deformation of the head of the buckle 203 is deformed and slipped. We can thicken the plastic of the head of the hook 203 and become difficult to deform; 2.
  • the head of the hook 103 is deformed and slipped, but one side of the hook 103 is fixed on the needle seat and will not be deformed.
  • the opening force is very large.
  • the sheath snap block 204 defines the end of the sheath buckle 203 between the edge of the safety cover 2 and the needle seat, so that the protection The end of the sleeve 203 cannot be deflected left and right to prevent the sheath buckle 203 from slipping off from both sides of the needle holder 103, and The sheath buckle 203 cooperates with the sheath snap blocks 204 on both sides to form a continuous blocking structure for the needle holder hooks 103.
  • the elastic folding mechanism 4 is composed of a fixed connecting plate 401 and a right angle connecting plate 402.
  • the fixed connecting plate 401 is vertically and fixedly connected to the side wall of the needle holder 101, and the other end of the fixed connecting plate 401 and the right angle connecting plate 402 are fixed.
  • One end of the right angle connecting plate 402 is fixedly connected to the lower end of the safety protective cover 2, and the joint of the fixed connecting plate 401 and the right angle connecting plate 402 forms a crease line 403, and the right angle connecting plate 402 is inverted along the crease line 403.
  • a reinforcing rib 104 is disposed at each of the two outer walls of the upper portion of the upper portion of the needle holder 101, and the needle seat hook 103 is disposed at the top end of the reinforcing rib 104.
  • the closing surface 202 is composed of an upper portion 2021 and a lower portion 2022.
  • the connection between the upper portion 2021 and the lower portion 2022 is a continuous curved surface 2023, and the upper portion 2021 and the lower portion 2022 form an inner portion of less than 178 degrees and greater than 120 degrees. Angle.
  • the design structure can ensure that the needle tube is compressed and bent in the occluded state, and forms a reverse force on the inner wall of the closed surface 202 to increase the firmness coefficient. At the same time, the design structure can also minimize the volume of the product, which is conducive to packaging and transportation.
  • a hollow tube fixing hook 205 is disposed in the hollow inner cavity of the safety protective sleeve 2, and the needle tube fixing hook 205 is matched with the needle tube 102.
  • the sheath buckle forms a directional force C under the release of the saving force B, and under the action of the hook, the needle holder hook is hung and interlocked to complete the hooking action of the two.
  • the above process is the action of the safety cover and the injection needle being engaged. Step, because the sheath buckle is deformed by the force to complete the hook, the magnitude of the force deformation force is related to the operation feel, because the deformation part of the sheath buckle is very thin, after the test calculation, the force value is very small, about 0.5N, the operation feel Very mild and very comfortable for clinical use.
  • the bite between the sheath buckle and the needle seat hook is a barbed type.
  • the stability is excellent, very firm and the only failure. It may only be that the buckle and the hook are deformed or broken. After testing and taking into account the characteristics of the material itself, the deformation release force value needs to reach 15N or more (regardless of the force value of the needle tube disengagement). Both the safety factor and the stability factor of the instrument have reached the expected effect value.
  • the injection needle 1 is connected to the blood collection tube 5.
  • the injection needle 1 is connected to the insulin pen 6.
  • the needle holder hook 103 is formed by thermal deformation at the upper end of the rib 104.
  • the utility model has the advantages that the mold structure is simple, the mold release rate is high, and the heat deformation is completed at the time of product assembly.
  • the hub hook 103 is formed at the upper end of the rib 104 by a Haval mold. Its characteristic is that it can be molded by one injection molding.

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

Abstract

一种安全注射针,注射针(1)由针座(101)和针管(102)构成,针座(101)通过一弹性翻折机构(4)与安全保护套(2)连接,针座(101)的侧壁上设有两个对称分布的针座卡勾(103),安全保护套(2)中空的内腔中设有两个对称分布的护套卡扣(203),两个护套卡扣(203)与两个针座卡勾(103)相配合,两个护套卡扣(203)的外侧均设有一护套卡扣挡块(204)。注射针采用设置于针座(101)侧壁的双针座卡勾(103)结构,配合设置于安全保护套(2)内腔的双护套卡扣(203),护套卡扣(203)与针座卡勾(103)卡合过程轻巧便捷,所需推力只需要0.5N左右,可实现单手操作,护套卡扣(203)的外侧还设置了护套卡扣挡块(204),能有效防止护套卡扣(203)与针座卡勾(103)发生松脱。

Description

一种安全注射针 技术领域
本发明涉及医疗器械的技术领域,具体地说是一种安全注射针。
背景技术
对比文件一,专利申请号:201410114478.7,申请日:2014.03.26,专利权人:温州市贝普科技有限公司,本案公开了“一种安全采血针”,包括一针座及一贯穿所述针座的双头针管,所述双头针管一端为静脉穿刺针,其另一端为插管针,其特征在于:所述安全采血针还包括一安全护套、一连接机构及一卡座,所述卡座固定在所述针座上,所述安全护套通过连接机构连接至所述卡座,所述安全护套可以以连接机构为中心转动,所述安全护套为中空腔体,其腔体内设有至少一针管安全钩。所述安全护套为一筒状物,所述安全护套的侧壁上朝向所述针头的一侧设有一开口,所述开口的长度大于所述针头的长度,所述安全护套的侧壁上位于所述开口两侧的位置分别形成一保护翼片,两个保护翼片相对设置。所述安全护套内设有两个针管安全钩,所述针管安全钩的钩体根部位于两个保护翼片之间的安全护套内侧壁上,所述针管安全钩钩体的弯折点处形成一正对两个保护翼片之间的安全护套内侧壁的锐角,两个针管安全钩的钩体方向相反,针管安全钩可以钩在针管上。所述安全护套内设有两个护套卡扣,所述护套卡扣为一突起的块状物,两个护套卡扣位置相对,所述护套卡扣设置于保护翼片的内侧壁上,所述卡座上设有与所述护套卡扣形状相应的两个卡口,所述护套卡扣可以卡在所述卡口上。所述卡座为一环状物,套在所述针座外表面,该环的大小、形状与所述针座外侧相对应。所述卡座为一中空腔体,套在所述针座外表面,该腔体的大小、形状与所述针座相对应。所述护套卡扣设置于靠近连接机构处的安全护套内侧壁上。所述连接机构包括一翻折 机构及一弹性机构,所述弹性机构的两端分别连接至所述翻折机构的两端,所述弹性机构位于所述翻折机构正下方。所述静脉穿刺针外部设有一穿刺针帽,所述穿刺针帽卡在所述针座上;所述插管针外部设有一插管针帽,所述插管针帽卡在所述针座上。
对比文件二,专利申请号:201410114477.2,申请日:2014.03.26,专利权人:温州市贝普科技有限公司,本案公开了“一种安全注射器”,包括一筒体及一针头,所述针头包括一针座及一针管,其特征在于:所述安全注射器还包括一安全护套、一连接机构及一卡座,所述卡座固定在所述针座上,所述安全护套通过连接机构连接至所述卡座,所述安全护套可以以连接机构为中心转动,所述安全护套为中空腔体,其腔体内设有至少一针管安全钩。所述安全护套为一筒状物,所述安全护套的侧壁上朝向所述针头的一侧设有一开口,所述开口的长度大于所述针头的长度,所述安全护套的侧壁上位于所述开口两侧的位置分别形成一保护翼片,两个保护翼片相对设置。所述安全护套内设有两个针管安全钩,所述针管安全钩的钩体根部位于两个保护翼片之间的安全护套内侧壁上,所述针管安全钩钩体的弯折点处形成一正对两个保护翼片之间的安全护套内侧壁的锐角,两个针管安全钩的钩体方向相反,针管安全钩可以钩在针管上。所述安全护套内设有两个护套卡扣,所述护套卡扣为一突起的块状物,两个护套卡扣位置相对,所述护套卡扣设置于保护翼片的内侧壁上,所述卡座上设有与所述护套卡扣形状相应的两个卡口,所述护套卡扣可以卡在所述卡口上。所述卡座为一环状物,套在所述针座外表面,该环的大小、形状与所述针座下部相对应。所述卡座为一中空腔体,套在所述针座外表面,该腔体的大小、形状与所述针座相对应。所述护套卡扣设置于靠近连接机构处的安全护套内侧壁上。所述连接机构包括一翻折机构及一弹性机构,所述弹性机构的两端分别连接至所述翻折机构的两端,所述弹性机构位于所述翻折机构正下方。所述针头外部设有一针帽,所述针帽底部套在卡座上。
从现有两份对比文件中可以看出,现有安全注射针均采用侧向安全护套结构,安全护套内设置有与注射针针管配合的钩体,利用钩体与针管的咬合来实现安全护套与针管的相对固定,针管被隐藏在安全护套内,最终实现注射针的安全防护,有效避免意外刺伤事故。
在临床使用过程中,现有技术所记载的安全注射针在使用过程中仍然存在诸多问题,1、安全护套扣入的时候,必须要用较大的力,临床大批量使用时医护人员操作困难;2、钩体结构与针管之间的卡合存在一定的缺陷,当受到一定程度的外力时,两者容易发生脱离,稳定性和安全性均不甚理想;3、当安全护套与针管卡合后,针管仍然保持在笔直的状态,钩体与针管之间的咬合强度不大,针管在钩体内还有活动的余地,导致针管锁定结构稳定性差;4、为了实现使用后方便的将针尖扣锁在安全保护套内,很多专利另外增加了扣锁的部件或者将普通注射针针座改大,因为一次性产品的使用量非常大,造成塑料浪费、增加生产成本。
发明内容
本发明的目的在于提供一种安全注射针,其在针座侧壁上设置卡勾部件并且与安全保护套内的反向具有弹性根部卡扣部件相配合,该设计结构使得安全保护套在被扣入时弹性根部弹开扣入,手感非常轻松,经过测试计算,所需推力约为0.5N左右,临床使用时可以单手操作非常舒适;扣入后如果要打开安全保护套,卡扣的弹性根部随着针座卡勾部件作用力的方向倾斜,产生很强的抗拉力,很难打开安全保护套,克服了现有技术中存在的缺点和不足。利用普通针座的设计,最少程度增加用于实现安全功能的部件,减少产品体积,让产品成本更低更环保。
为了实现上述目的,本发明的技术方案为:一种安全注射针,它包括注射针,所述注射针由针座和针管构成,所述针座通过一弹性翻折机构与安全保护套连接,针座的侧壁上设有两个对称分布的针座卡勾,所述安全保护套,安全 保护套整体呈长条状结构,安全保护套的内腔呈中空状,安全保护套的下端与上述弹性翻折机构的一端连接,弹性翻折机构的另一端与针座的侧壁固定连接,安全保护套的上端呈悬空状,安全保护套随弹性翻折机构的翻折而翻转,安全保护套靠近上述针管的一侧形成开口,安全保护套处与开口相对的另一侧呈形成一封闭面,安全保护套中空的内腔中设有两个对称分布的具有弹性根部的护套卡扣,所述的两个护套卡扣与上述两个针座卡勾相配合,护套卡扣的外侧均设有一护套卡扣挡块。
本发明公开了一种安全注射针,其采用设置于针座侧壁的双针座卡勾结构,配合设置于安全保护套内腔的双护套卡扣,护套卡扣与针座卡勾卡合过程轻巧便捷,所需推力只需要0.5N左右,可实现单手操作,护套卡扣的外侧还设置了护套卡扣挡块,能有效防止护套卡扣与针座卡勾发生松脱。本专利技术的针座部分仍然沿用了现有常规针座的设计结构,仅仅增设了针座卡勾,该结构可一次成型,不需要为了实现安全卡扣功能而增加针座的体积或增加一个可以卡住安全帽的其它组件,有效控制成本、节省材料、简单而且有效的实现了产品的安全操作,另外,沿用常规针座的另一个好处在于,针座的位置更小,产品装配时,一条工装一次可以装配更多产品,生产效率也更高。产品整体设计用简洁的结构巧妙的实现了各项功能要求,稳定性和安全性均可达到理想效果。
附图说明
图1为本发明安全注射针结构示意图。
图2为本发明安全注射针立体图。
图3为本发明安全注射针第一使用状态图。
图4为本发明安全注射针第二使用状态图。
图5为本发明安全注射针第三使用状态图。
图6为本发明注射针与安全保护套锁定状态示意图。
图7为本发明第一实施例结构示意图。
图8为本发明第一实施例立体图。
图9为本发明第一实施例第一使用状态图。
图10为本发明第一实施例第二使用状态图。
图11为本发明第一实施例第三使用状态图。
图12为本发明第一实施例注射针与安全保护套锁定状态示意图。
图13为本发明第二实施例结构示意图。
图14为本发明第二实施例立体图。
图15为本发明第二实施例第一使用状态图。
图16为本发明第二实施例第二使用状态图。
图17为本发明第二实施例第三使用状态图。
图18为本发明第二实施例注射针与安全保护套锁定状态示意图。
图19为本发明针座卡勾与护套卡扣配合过程第一状态示意图。
图20为本发明针座卡勾与护套卡扣配合过程第二状态示意图。
图21为本发明针座卡勾与护套卡扣配合过程第三状态示意图。
图22为本发明针座卡勾与护套卡扣配合过程第四状态示意图。
具体实施方式
下面参照附图,对本发明进一步进行描述。
本发明公开了一种安全注射针,如图1和图2所示,它包括注射针1,所述注射针1由针座101和针管102构成,其区别于现有技术在于:所述针座101通过一弹性翻折机构4与安全保护套2连接,针座101的侧壁上设有两个对称分布的针座卡勾103,所述安全保护套2整体呈长条状结构,安全保护套2的内腔呈中空状,安全保护套2的下端与上述弹性翻折机构4的一端连接,弹性翻折机构4的另一端与针座101的侧壁固定连接,安全保护套2的上端呈悬空状,安全保护套2随弹性翻折机构4的翻折而翻转,安全保护套2靠近上述针管102的一侧形成开口201,安全保护套2处与开口201相对的另一侧呈形成 一封闭面202,安全保护套2中空的内腔中设有两个对称分布的护套卡扣203,卡扣203具有可以弹动的根部2031(不需要使用其他材料,只需要将该部位做到一定薄度,和安全保护套一次注塑成型),所述的两个护套卡扣203与上述两个针座卡勾103相配合,护套卡扣203的外侧均设有一护套卡扣挡块204。
在具体实施时,所述针座卡勾103的上端部形成向一侧折弯的勾端1031,护套卡扣203由具有弹性的根部2031和卡扣端部2030构成,护套卡扣203的卡扣端部2030形成一向封闭面202的折弯,针座卡勾103与护套卡扣203的初始接触点为勾端的折弯处和卡扣端部2030的折弯处,并且,勾端与卡扣端部2030的折弯方向相反。该结构设计能确保针座卡勾103与护套卡扣203的初始接触时,两者的触摸面是两个圆弧的折弯面,或者其中一个是圆弧的折弯面,目的是将触发两者咬合的推力降到最低。同时护套卡扣203具有弹性根部2031,当扣安全护套时针座卡勾103顶住护套卡扣203,弹性根部2031顺着针座卡勾103顶的方向(图20的A方向)倾斜,卡勾顶部1030顶过卡扣203顶部时,护套卡扣203按照图21的方向回弹,扣入针座卡勾103,该扣入的力通过实验证实只需要0.5N左右。该技术特性是目前市场上同类产品所无法实现的。(局部放大见图19-图21)
当用外力想要将安全护套和针座打开时,卡勾103以图22的方向拉动卡扣203,卡扣203的弹性根部顺势向C的方向倾斜,这个时候安全护套和针座的打开力变成了:1、卡扣203头部变形滑脱的力,我们可以加厚卡勾203头部的塑料变的很难变形;2、变成拉断弹性根部2031的力,想要拉断塑料是非常困难的;3、卡勾103头部变形滑脱,但是卡勾103的一边是固定在针座上的,不会变形。综上所述所以打开力是很大的。
在具体实施时,所述勾端1031与卡扣端部2030咬合时,护套卡扣挡块204将护套卡扣203的端部限定于安全保护套2边沿和针座之间,使得护套卡扣203的端部不能左右偏离,防止护套卡扣203从针座卡勾103的两侧滑脱,并且, 护套卡扣203与两侧的护套卡扣挡块204配合对针座卡勾103形成一连续的阻挡结构。从上述结构可以看出,当勾端与卡扣端通过反向结构咬合后,通过外力还是有可能将两者分开的,理由是,护套卡扣203可以从针座卡勾103的两侧滑脱,但当护套卡扣203的两侧被护套卡扣挡块204所阻挡后,这种可能性就接近于零。
在具体实施时,所述弹性翻折机构4由固定连接板401和直角连接板402构成,固定连接板401与针座101侧壁垂直固定连接,固定连接板401的另一端与直角连接板402的一端连接,直角连接板402的另一端与安全保护套2的下端固定连接,固定连接板401与直角连接板402的连接处形成折痕线403,直角连接板402沿折痕线403翻转。
在具体实施时,所述针座101上段的两侧外壁处各设有一条加强筋104,上述针座卡勾103设置于加强筋104的顶端处。
在具体实施时,所述封闭面202由上部2021和下部2022构成,上部2021和下部2022的连接处为连续的弧面2023,上部2021和下部2022之间形成小于178度并大于120度的内夹角。该设计结构能确保在咬合状态下针管受压弯曲,并对封闭面202内壁形成反向作用力,增加牢固系数。同时,该设计结构还能最大程度的减少产品体积,利于包装和运输。
在具体实施时,所述安全保护套2中空的内腔中设有一针管固定钩205,该针管固定钩205与上述针管102相配合。
在具体操作过程中,如图3中所示,当注射完成后,将安全保护套沿着着力点A的方向下压时,带动护套卡扣往下呈弧形轨迹位移,当护套卡扣触及针座卡勾时,护套卡扣会被阻挡,经支点3向后变形,形成储蓄力B,如图4中所示,继续下压,当护套卡扣的顶点超过针座卡勾的顶点时,护套卡扣在储蓄力B的释放下形成方向力C,在其作用下抱住针座卡勾,相互咬合,完成两者的挂钩动作。如图4中所示,上述整个过程为安全保护套与注射针卡合的动作 步骤,因为护套卡扣受力变形完成挂钩,受力变形力的大小关系到操作手感,因为护套卡扣的变形部位很薄,经过测试计算,力值非常小,约0.5N,操作手感非常轻微,临床使用非常舒适。
在具体操作过程中,如图5和图6中所示,将安全保护套沿着力D的方向拉动时,带动护套卡扣沿着力E方向拉伸,会造成两个护套卡扣向两侧边发生移动,带来脱钩的风险,故本技术方案中增设了护套卡扣挡块,用于阻挡护套卡扣,故护套卡扣只承受力E,不影响护套卡扣与针座卡勾的咬合状态,故在实际使用过程中,完全杜绝了脱钩的问题,达到强化安全的目的。本产品的安全性能的考量在于卡扣与卡钩脱开失效的力值大小,护套卡扣与针座卡勾之间的咬合为倒钩式咬合,稳定性极佳,非常牢固,唯一失效的可能仅在于卡扣与卡勾变形或断裂,经测试计算,并考虑到材料本身的特性,变形脱开力值需要达到15N以上(不考虑针管脱开的力值),由此,可见产品本身的安全系数和稳定系数均达到预期的效果值。
在本发明第一实施例中,如图7-图12所示,所述注射针1与采血管5连接。
在本发明第二实施例中,如图13-图18所示,所述注射针1与胰岛素笔6连接。
在具体实施时,所述针座卡勾103在加强筋104上端通过热变形成形。其特点是,模具结构简单,出模率高,热变形在产品组装时候完成。
在具体实施时,所述针座卡勾103在加强筋104上端通过哈弗模具成形。其特点是,可以一次注塑加工成型。
以上内容是结合具体的优选实施方式对本发明所作的进一步详细说明,不能认定本发明具体实施只局限于上述这些说明。对于本发明所属技术领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干简单推演或替换,都应当视为属于本发明的保护范围。

Claims (11)

  1. 一种安全注射针,它包括注射针(1),所述注射针(1)由针座(101)和针管(102)构成,其特征在于:所述针座(101)通过一弹性翻折机构(4)与安全保护套(2)连接,针座(101)的侧壁上设有两个对称分布的针座卡勾(103),所述安全保护套(2)整体呈长条状结构,安全保护套(2)的内腔呈中空状,安全保护套(2)的下端与上述弹性翻折机构(4)的一端连接,弹性翻折机构(4)的另一端与针座(101)的侧壁固定连接,安全保护套(2)的上端呈悬空状,安全保护套(2)随弹性翻折机构(4)的翻折而翻转,安全保护套(2)靠近上述针管(102)的一侧形成开口(201),安全保护套(2)处与开口(201)相对的另一侧呈形成一封闭面(202),安全保护套(2)中空的内腔中设有两个对称分布的护套卡扣(203),所述的两个护套卡扣(203)与上述两个针座卡勾(103)相配合,护套卡扣(203)的外侧均设有一护套卡扣挡块(204)。
  2. 根据权利要求1所述的一种安全注射针,其特征在于:所述针座卡勾(103)的上端部形成向一侧折弯的勾端(1031),护套卡扣(203)由具有弹性的根部(2031)和卡扣端部(2030)构成,护套卡扣(203)的卡扣端部(2030)形成一向封闭面(202)的折弯,针座卡勾(103)与护套卡扣(203)的初始接触点为勾端的折弯处和卡扣端部(2030)的折弯处,并且,勾端与卡扣端部(2030)的折弯方向相反。
  3. 根据权利要求2所述的一种安全注射针,其特征在于:所述勾端(1031)与卡扣端部(2030)咬合时,护套卡扣挡块(204)将护套卡扣(203)的端部限定于安全保护套(2)边沿和针座之间,使得护套卡扣(203)的端部不能左右偏离,防止护套卡扣(203)从针座卡勾(103)的两侧滑脱,并且,护套卡扣(203)与两侧的护套卡扣挡块(204)配合对针座卡勾(103)形成一连续 的阻挡结构。
  4. 根据权利要求1所述的一种安全注射针,其特征在于:所述弹性翻折机构(4)由固定连接板(401)和直角连接板(402)构成,固定连接板(401)与针座(101)侧壁垂直固定连接,固定连接板(401)的另一端与直角连接板(402)的一端连接,直角连接板(402)的另一端与安全保护套(2)的下端固定连接,固定连接板(401)与直角连接板(402)的连接处形成折痕线(403),直角连接板(402)沿折痕线(403)翻转。
  5. 根据权利要求1所述的一种安全注射针,其特征在于:所述针座(101)上段的两侧外壁处各设有一条加强筋(104),上述针座卡勾(103)设置于加强筋(104)的顶端处。
  6. 根据权利要求1所述的一种安全注射针,其特征在于:所述封闭面(202)由上部(2021)和下部(2022)构成,上部(2021)和下部(2022)的连接处为连续的弧面(2023),上部(2021)和下部(2022)之间形成小于178度并大于120度的内夹角。
  7. 根据权利要求1所述的一种安全注射针,其特征在于:所述安全保护套(2)中空的内腔中设有一针管固定钩(205),该针管固定钩(205)与上述针管(102)相配合。
  8. 根据权利要求1所述的一种安全注射针,其特征在于:所述注射针(1)与采血管(5)连接。
  9. 根据权利要求1所述的一种安全注射针,其特征在于:所述注射针(1)与胰岛素笔(6)连接。
  10. 根据权利要求1所述的一种安全注射针,其特征在于:所述针座卡勾(103)在加强筋(104)上端通过热变形成形。
  11. 根据权利要求1所述的一种安全注射针,其特征在于:所述针座卡勾(103)在加强筋(104)上端通过哈弗模具成形。
PCT/CN2016/110122 2016-11-11 2016-12-15 一种安全注射针 Ceased WO2018086192A1 (zh)

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BR112019009528-4A BR112019009528B1 (pt) 2016-11-11 2016-12-15 Agulha de injeção de segurança
US16/349,285 US11033213B2 (en) 2016-11-11 2016-12-15 Secure injection needle
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