WO2016066014A1 - 安全式胰岛素笔针 - Google Patents

安全式胰岛素笔针 Download PDF

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Publication number
WO2016066014A1
WO2016066014A1 PCT/CN2015/091924 CN2015091924W WO2016066014A1 WO 2016066014 A1 WO2016066014 A1 WO 2016066014A1 CN 2015091924 W CN2015091924 W CN 2015091924W WO 2016066014 A1 WO2016066014 A1 WO 2016066014A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
trigger protector
guiding
insulin pen
trigger
Prior art date
Application number
PCT/CN2015/091924
Other languages
English (en)
French (fr)
Inventor
胡超宇
Original Assignee
杭州普昂医疗科技有限公司
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 杭州普昂医疗科技有限公司 filed Critical 杭州普昂医疗科技有限公司
Priority to EP15855618.3A priority Critical patent/EP3141276B1/en
Priority to US15/323,354 priority patent/US10022505B2/en
Publication of WO2016066014A1 publication Critical patent/WO2016066014A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3257—Semi-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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
    • A61M5/3272—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position having projections following labyrinth paths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3107—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle for needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3254—Shielding of proximal needles, e.g. for pen needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/0007—Special media to be introduced, removed or treated introduced into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids

Definitions

  • the present invention relates to the field of medical devices, and more particularly to an insulin injection device.
  • Insulin injection devices such as insulin pens and injection needles have been widely used as a method for treating diabetes. Its main function is to accurately inject insulin into the diabetic patient through the injection device to achieve the purpose of controlling the patient's blood sugar.
  • the conventional injection needle includes a needle holder, a needle tube and an outer protective shell. After the protective shell is removed before use, the insulin injection needle is directly exposed to the outside, and since it has no safety protection structure after use, it is easy to accidentally accidentally touch the needle. Lead to cross infection. At the same time, since there is no necessary protective structure, the needle can be reused after use, and there is a risk of being reused.
  • the Chinese utility model patent CN203315464U provides a safe insulin needle, including a needle seat, a needle tube, a self-locking seat, a needle sheath and the like.
  • the utility model provides a safety insulin needle with a built-in safety needle structure, an outer sleeve of an insulin syringe needle with an elastically stretchable sheath, and a self-locking mechanism for limiting the sheath, when the insulin pen is screwed into the needle After the seat, the self-locking mechanism will snoring on its own, and the sheath can be freely moved up and down to perform normal insulin injection.
  • the safety insulin needle has the following disadvantages: 1.
  • the safety insulin needle cannot protect the needle tip immediately after the injection is completed, but the protection mechanism can protect the needle tip after exiting the injection device such as the insulin pen. Therefore, there is still a risk of cross-infection due to mis-touch; 2. Insulin is generally injected into the subcutaneous tissue layer, but not in the muscle layer. Because the muscle layer absorbs quickly and easily causes blood sugar fluctuations, so in many cases, the needle is injected.
  • the needle is inserted at a 45° angle; and the safe insulin injection needle provided by the utility model has a structure such as a needle sheath, so that the needle can only be inserted at a 90° angle, thereby making the needle longer or
  • the subcutaneous tissue layer of the patient is thinner, which not only increases the difficulty of operation, but also makes the injection have a greater risk or even impossible to complete the injection. 3.
  • the resistance of the injection needle is relatively large, thereby making the patient Poor experience, the same difficulty increases the operation; 4 the safety of the insulin needle structure is more complex, manufacturing High cost, which increases the cost of use for patients, and is aggravated by long-term use. The financial burden of the patient.
  • the present invention provides a safe insulin pen needle for the insufficiency of the prior art safety insulin injection needle, inconvenient use, poor patient experience and high cost.
  • a safety insulin pen needle includes a needle hub and a needle tube assembly base disposed on the needle seat, the needle tube assembly base is provided with a needle tube, and the needle tube assembly base is disposed at a center of one end of the needle seat.
  • the other end of the needle seat is provided with an insulin pen fitting portion matched with the insulin injection device; at least one protruding post is further disposed on the outer side wall of the needle seat near the end of the needle fitting assembly base;
  • a trigger protector sleeved on the outside of the needle seat, the trigger protector is sleeve-shaped, the two ends are respectively a machine end of the mouth and a patient end away from the machine end, and are provided at the patient end Through hole for the needle to pass through
  • the trigger protector side wall is provided with at least one guiding groove matched with the post on the needle seat, the guiding groove is provided with at least one initial fixing portion and an end fixing portion, and the initial fixing portion Close to the patient end, the end fixing portion is away from the patient end, and when the post is located at the initial fixing portion, the needle tube protrudes from the through hole to trigger the protector, and when the post is located at the end fixing portion, the needle tube Located in the trigger protector;
  • the spring is disposed between the needle seat and the trigger protector, and the direction of the spring elastic force is the same as the axial direction of the trigger protector; the post on the needle seat
  • the needle hub is movably coupled to the trigger protector by being fitted into a guide slot on the trigger protector.
  • the card holder peripheral has a card fastener, and the card fastener is provided with an elastic claw that can cooperate with the trigger protector; when the post is located at the initial fixing portion, the claw card Tightly fitting on the outer wall of the upper part of the triggering machine end, when the post is located at the end fixing portion ⁇ , the claw is located below the bottom of the trigger protector machine end or is engaged with the bottom edge of the trigger protector machine end.
  • the guiding slot includes a first guiding segment, a second guiding segment and a transition segment connected between the first guiding segment and the second guiding segment, the first guiding segment
  • the starting end of the first guiding section is connected to the beginning end of the transition section, and the end of the transition section is connected to the starting end of the second guiding section, the second guiding
  • the end of the lead segment is an end fixing portion; the starting end of the first guiding segment is farther from the patient end than the end of the first guiding segment, and the end of the second guiding segment is more than the starting end of the second guiding segment Close to the machine side.
  • at least one of the initial fixing portion and the end fixing portion is provided with a one-way access structure.
  • the one-way access structure is a latching mechanism or an elastic tongue.
  • annular cavity is disposed between the needle tube assembly base and the side wall of the needle seat, and the patient end of the trigger protector is internally provided with a downwardly extending boss, and one end of the spring is mounted on The other end of the annular cavity on the needle seat is mounted on a boss inside the patient end of the trigger protector.
  • an angle between a central axis direction of the guiding groove transition section and an axial direction of the trigger protector is no more than 45 degrees.
  • the housing further includes a sleeve, and the sleeve is disposed outside the needle holder and the trigger protector, and one end is closed and a sleeve extending inward for protecting the needle tube is disposed inside.
  • the card fastener is provided with a mounting base that cooperates with the needle seat insulin pen fitting portion, and the elastic claw is disposed on the mounting base; the outer side of the mounting base is provided with evenly distributed ridges or The fitting groove, the inner side surface of the mouth end of the outer casing is provided with a fitting opening or a rib which cooperates with the ridge or the fitting groove.
  • the mounting base of the fastener is provided with a guiding sleeve that is slidably fitted on the trigger protector, and the guiding sleeve is provided with a positioning hole, and the elastic claw is disposed on the Give way to the hole.
  • the gap between the edge of the retaining hole and the claw is small, and the external force cannot act on the claw when the claw is located below the bottom of the trigger protector end or is engaged with the bottom edge of the trigger protector machine end. ⁇ , the claw cannot be pulled or twisted by an external force, thereby ensuring that the trigger protector does not return to the original position again, and the insulin needle of the present invention is prevented from being used twice.
  • the outer casing is mounted on the mounting base of the fastener, and a sealing paper/film is adhered or sealed at the mouth end.
  • the safety type insulin pen needle of the present invention before use, the trigger protector is in a position to be triggered, and the needle tube is located outside the trigger protector, similar to the conventional insulin injection needle, the patient can freely select the injection according to the need.
  • the angle avoids the accident that the needle tube is too long to be used or the injection position is too deep, which is extremely convenient for the patient compared to the existing safety needle.
  • the safe insulin pen needle of the invention adopts a self-trigger protection structure, and the trigger protector itself is a trigger, and acts as a needle tip protector after the trigger. Since it is triggered during use, use Immediate protection immediately, thereby overcoming the existing safety needle can not be immediately protected after use, need to exit the injection device before the protection of the defect, thereby more effectively avoiding the risk of accidental misuse of the needle tip cross-infection after use; After the trigger protector is triggered to bounce, the two claws of the fastener are located below the bottom of the trigger protector end or tightly engaged with the bottom edge of the trigger protector machine end to ensure that the trigger protector is subjected to an external force. It will not return to the original trigger position again; its further design of the tongue structure can also make it difficult to return to the original trigger position after the trigger protector is triggered, so that the stylus of the present invention is safer after use and Will not be used twice.
  • the safe insulin pen needle of the present invention is triggered by the use of a cymbal, and there is no structure such as a needle sheath, and the needle insertion resistance is small compared to the existing safety needle, which reduces the operation difficulty, and The patient experience is better.
  • the guiding grooves on the trigger protector are preferably set to three, and the number of the posts on the outer edge of the corresponding needle holder is also set to three.
  • the post on the needle seat is located at the first fixed position of the trigger slot of the trigger protector, that is, the initial fixed portion, and the three posts are designed to make the trigger protector Uniform, to ensure that it does not trigger automatically due to one side; during use, the three guiding grooves make the trigger protector easy to deflect due to uniform force, and naturally complete the trigger;
  • the slot ensures that the trajectory of the trigger protector is up along the axis of the axis, and there is no possibility of triggering due to friction from the needle seat, and the same is also beneficial for the post to finally enter the second through the second guiding segment.
  • the fixed position is the end fixing portion.
  • the safety type insulin pen needle of the present invention after using the sputum, first tears off the sealing paper/film, puts the pen needle on an insulin injection device (such as an insulin pen), sets the dose to be injected, and then removes the outer casing. Puncture the needle into the body and inject it. After the injection, pull out the injection site of the human body, remove the needle and discard it. Its simple structure, safe and practical, and low manufacturing cost not only facilitate patient use, but also further reduce the economic burden on patients.
  • FIG. 1 is a cross-sectional view of one embodiment of a safe insulin pen needle of the present invention
  • FIG. 2 is a schematic structural view of a needle holder in the embodiment shown in FIG. 1;
  • 3 is a schematic structural diagram of an embodiment of a trigger protector in the embodiment shown in FIG. 1;
  • FIG. 4 is a schematic structural view of another embodiment of a trigger protector in the embodiment shown in FIG. 1;
  • Figure 5 is a cross-sectional view showing another embodiment of the present invention.
  • FIG. 6 is a schematic structural view of the embodiment shown in FIG. 5 after removing the outer casing; [0029] FIG.
  • FIG. 7 is a schematic structural view of a card fastener in the embodiment shown in FIG. 5;
  • FIG. 8 is a schematic structural view of another embodiment of a card firmware in the present invention.
  • a safe insulin pen needle includes a needle hub 1.
  • one end of the hub 1 is provided with an insulin pen fitting portion 14 having a diameter larger than the rest of the needle hub, and a thread or a fitting opening is provided on the inner side surface for the insulin injection device (such as insulin).
  • the fit of the pen is provided with a ring of annular projections 16 on the outer side.
  • a needle tube assembly base 11 is provided at the center of the other end of the needle holder 1.
  • a needle tube 12 is disposed on the needle tube assembly base 11, and the needle tube 12 is located on the axis of the needle holder 1.
  • an annular cavity 15 is provided between the needle fitting base 11 on the hub 1 and the side wall of the hub; at the same time, at least one raised post 13 is provided on the upper portion of the outer wall of the hub 1; In this embodiment, the number of the posts 13 is three, and the contours are evenly distributed on the outer side wall of the needle seat.
  • a trigger protector 2 matching the size of the needle seat 1 is sleeved on the outside of the needle hub 1 .
  • the trigger protector 2 is sleeve-shaped, and the two ends are respectively a machine end 202 of the mouth and a patient end 201 away from the machine end, and a center end of the patient end 201 is provided with an extension to the machine end.
  • the boss 22 is provided with a bore 23 at the center of the boss for the needle tube 12 to pass through.
  • Trigger The side wall of the protector 2 is provided with the same number of guiding grooves 21 as the post 13 , and the guiding groove width is matched with the size of the post 13 .
  • the guiding slot 21 includes a first guiding section 211, a second guiding section 214 and a transition section 213 connected between the first guiding section and the second guiding section; wherein the starting end of the first guiding section
  • the end of the first guiding portion 211 is connected to the starting end of the transition portion 213, and the starting end of the first guiding portion is farther from the patient end 201 than the end of the first guiding portion; the transition portion 213
  • the end of the second guiding section is connected to the starting end of the second guiding section 214, and the end of the second guiding section is closer to the machine end 202 than the starting end of the second guiding section.
  • the angle a between the central axis n of the transition section 213 and the axis m of the trigger protector is preferably no more than 45 degrees, a may be 0. degree.
  • the guiding groove 21 on the trigger protector 2 is provided with a resilient tongue 216 in the second guiding section 214.
  • the minimum distance between the tongue and the upper edge of the second guiding section 214 is slightly smaller than the diameter of the post 13 on the hub 1, such that the post 13 can pass from the transition 213 into the second guiding section 214 through the gap.
  • the end fixing portion 215 is reached. When the post 13 is at the end fixing portion 215, the tab 13 does not easily come out of the end fixing portion 215 due to the blocking of the tongue 216, so that the trigger protector 2 cannot be returned to the initial position again.
  • the safety insulin pen needle in this embodiment further includes a spring 3 disposed between the needle hub i and the trigger protector 2 ; in particular, the spring 3 is stably mounted on The annular cavity 15 on the hub 1 is between the boss 22 in the trigger protector 2.
  • the safety type insulin pen needle of the present invention is further provided with an outer casing 4 outside the needle holder 1 and the trigger protector 2.
  • the housing 4 protects the insulin needle from contamination prior to use, avoiding contamination or accidental accidents.
  • a sealing paper/film 6 is further provided with a sealing or sealing member, so that the needle holder 1 and the needle tube 12 inside the outer casing 4 are in a closed environment before use, thereby avoiding contamination by the outside.
  • the sealing paper/film 6 of the mouthpiece 5 is first peeled off, and the insulin pen fitting portion 14 on the needle holder 1 is attached to the insulin pen; after the outer casing 4 is removed, the needle tube 12 can be exposed, thereby performing injection.
  • the safety insulin pen needle of the present invention Before the injection, the safety insulin pen needle of the present invention is in an untriggered state, and the post 13 on the outer edge of the side wall of the needle hub 1 is located in the initial fixing portion 212 of the guiding groove 21 on the side wall of the trigger protector 2 Then, the spring 3 is compressed, and the trigger protector 2 is subjected to the elastic force of the spring upward; at the same time, since the starting end of the first guiding section is the first The end of the guiding section is further away from the patient end, so that the post 13 does not slide out of the initial fixing portion 212, effectively preventing the trigger protector from being erroneously triggered; the needle tube 12 is extended by the through hole 23 of the patient end of the trigger protector. .
  • the safety type insulin pen needle in the embodiment is automatically triggered during use, there is no additional needle sheath structure or the like before use, similar to the traditional insulin pen needle, so the medical staff or the patient can freely select the needle. Angle, compared to the existing safety needle can only choose 90 ° angle into the needle, its use is more convenient. Peer, there is also a better patient experience during the injection process.
  • the needle tube 12 exposes the section of the trigger protector 2 and is inserted into the human body, and the top end of the trigger protector 2 contacts the human body, and the compression spring 3 is retracted by the force of the human body; 13 enters the first guiding segment 211 from the initial fixing portion 212 of the guiding groove of the trigger protector 2, and interacts with the upper edge of the first guiding segment 211 to cause the trigger protector 2 to rotate at a certain angle.
  • the post 13 reaches the end ⁇ of the first guiding section 21 1 , it is separated from the first guiding section 211 and enters the starting end of the transition section 213 , and then slides into the starting end of the transition section 21 3 .
  • the needle tube 12 is pulled out of the human body, and the trigger protector 2 is bounced in the direction of the needle tube 12 by the elastic force of the spring 3, and the post 13 slides down the transition portion 213 and further passes through the second guiding portion 214.
  • the end fixing portion 215 is entered.
  • the needle tube 12 is located in the trigger protector 2, thereby immediately protecting the needle tube 12, preventing the insulin injection needle after use from being exposed to the outside, and cross-infection due to accidental accidental contact.
  • the end of the second guiding section is closer to the machine end than the starting end of the second guiding section, and the triggering protector of the crucible is still subjected to the elastic force of the spring pointing to the patient end, the post does not slip.
  • the end fixing portion is taken out.
  • the guiding groove on the trigger protector is provided with an elastic tongue in the second guiding section, which can more effectively prevent the post from sliding out of the end fixing portion, thereby preventing the needle from exposing the trigger protector.
  • the technical object of the present invention has been achieved by the embodiment of the present invention with the above technical solutions, and the advantageous effects of the present invention are obtained.
  • the safety type insulin pen needle of the present invention may be reused after the injection is completed, and the post may be reused from the end fixing portion, or even returned to the initial fixing portion.
  • the invention has been further improved by the present invention.
  • the safety type insulin pen needle of the present invention is further provided with a fastener 3.
  • the fastener 3 includes a mounting base 31 that mates with the insulin pen fitting portion 14 on the hub 1 and two resilient jaws 32 that extend from the mounting base 31 toward the patient end 201 of the trigger protector 2.
  • the fastener 3 is provided with a groove 33 in the interior of the mounting base 31 for engaging with the annular protrusion 16 on the outer side of the insulin pen fitting portion 14 of the needle seat 1, and the fastener is inserted. 3 is attached to the insulin pen fitting portion 14. Further, on the outer side surface of the mounting base 31, a plurality of evenly distributed ribs or fitting grooves are provided, and the matching end of the outer casing 4 is provided with a matching opening matching the ridge or the fitting groove. Or a rib for mounting the outer casing 4 on the fastener 3.
  • the ends of the two claws 32 of the fastener 3 are located at the upper portion of the machine end 202 of the trigger protector 2, and are in close contact with the trigger protector under the action of the elastic force.
  • the outer wall is located at the upper portion of the machine end 202 of the trigger protector 2, and are in close contact with the trigger protector under the action of the elastic force.
  • the trigger protector 2 After the trigger protector 2 is triggered to pop up, the lower edge of the machine end is moved upward, so that the ends of the two claws 32 of the fastener 3 are located below the bottom of the trigger protector machine end, and are contracted toward each other, two cards
  • the distance between the ends of the claws is smaller than the outer diameter of the trigger protector; thereafter, the end of the jaws abuts against the bottom of the machine end of the trigger protector or a small gap between the bottom of the machine end, but the width of the gap is smaller than the needle tube The distance between the needle and the end of the patient end that triggers the protector.
  • the trigger protector 2 is bounced up, and after the machine end is moved up, the two claws 32 of the fastener 3 may be in a tightly engaged with the bottom edge of the trigger protector.
  • the above-mentioned fasteners are arranged such that it is difficult for the trigger protector to return to the initial position even under the action of an external force, thereby ensuring that the needle is not exposed to the outside of the trigger protector after the injection is completed, and the safety type of the present invention is effectively avoided.
  • the insulin pen needle is reused.
  • the base 31 of the fastener 3 is provided with a guide sleeve 34 which is slidably fitted on the trigger protector 2, and the guide sleeve 34 is provided.
  • a retaining hole 35 is provided, and the elastic claw 32 is disposed in the retaining hole 35. Specifically, the gap between the edge of the retaining hole 35 and the claw 32 is small, so that an external force cannot act on the claw 32.
  • the claw 32 is located below the bottom of the machine end of the trigger protector 2 or is engaged with the bottom edge of the trigger protector machine end, and the guide sleeve 34 can protect the claw 32, so that the card The claw 32 cannot be pulled or twisted by an external force, thereby ensuring that the trigger protector 2 does not return to the original position again, and the insulin needle of the present invention is prevented from being reused twice.

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Abstract

一种安全式胰岛素笔针，包括针座（1）及设于针座（1）上的针管装配基座（11）和针管（12），还包括设于针座（1）外部的触发保护器（2）及设于触发保护器（2）与针座（1）之间的弹簧（4）。触发保护器（2）侧壁上设有特定结构的导引槽（21），针座（1）侧壁外缘设有与导引槽（21）对应的卡柱（13），使得触发保护器（2）在使用前处于待触发状态，在使用时才被触发。从而在使用后保护注射针不暴露在外面，避免了因误触或二次使用引起交叉感染。这种安全式胰岛素笔结构简单，制造成本低，适合患者长期使用。

Description

安全式胰岛素笔针 技术领域
[0001] 本发明涉及医疗器械领域， 尤其是一种胰岛素注射装置。
背景技术
[0002] 胰岛素注射装置如胰岛素笔和注射针作为一种治疗糖尿病的方法， 已被广泛普 及使用。 其主要功能是通过注射装置向糖尿病患者体内精准输注胰岛素， 来达 到控制患者血糖的目的。
[0003] 传统的注射针包括针座、 针管与外面的保护壳， 使用前去掉保护壳后， 胰岛素 注射针直接暴露在外面， 使用后因其无安全保护结构， 从而容易发生意外误触 针头而导致交叉感染。 同吋， 由于没有必要的防护结构， 该种注射针经使用后 ， 还可以被再次使用， 从而存在被重复使用的风险。
[0004] 基于此， 中国实用新型专利 CN203315464U提供了一种安全式胰岛素针， 包括 针座、 针管及自锁座、 针护套等保护装置。 该实用新型提供的安全式胰岛素针 ， 采用内置式安全注射针结构， 胰岛素注射器针外部套接有可弹性伸缩的护套 ， 并利用自锁机构对护套进行限位， 当胰岛素笔旋入针座后， 自锁机构会自行 打幵， 护套便可自由上下弹性位移， 进行正常的胰岛素注射。 但是， 该安全式 胰岛素针存在以下缺点： 1、 该安全式胰岛素针在完成注射后， 并不能立即对针 尖进行保护， 而是在退出注射装置如胰岛素笔后， 保护机构才能对针尖进行保 护， 从而依然存在因误触而发生交叉感染的风险； 2、 胰岛素一般注射在皮下组 织层， 而不注射在肌肉层， 因为肌肉层吸收快， 易引起血糖波动， 所以在注射 吋， 很多情况下针头是以 45°角进针的； 而该实用新型提供的安全式胰岛素注射 针， 由于存在针护套等结构， 使得该注射针使用吋只能以 90°角进针， 从而在针 头较长或患者皮下组织层较薄吋， 不仅增加了操作难度， 还使得注射存在较大 的风险甚至无法完成注射； 3、 同样由于存在针护套等结构， 在注射吋进针阻力 比较大， 从而使患者体验较差， 同吋增加了操作的难度； 4、 该安全式胰岛素针 结构较为复杂， 制造成本高， 从而增加了患者的使用成本， 长期使用下加重了 患者的经济负担。
技术问题
问题的解决方案
技术解决方案
[0005] 本发明针对现有安全胰岛素注射针保护不及吋， 使用不方便， 患者体验较差且 成本高的不足， 提供了一种安全式胰岛素笔针。
[0006] 为解决上述技术问题， 本发明采用了以下技术方案：
[0007] 安全式胰岛素笔针， 包括针座及设于该针座上的针管装配基座， 该针管装配基 座上设有针管， 所述针管装配基座设于针座一端的中心处， 所述针座另一端设 有与胰岛素注射装置配合的胰岛素笔装配部； 在靠近针管装配基座端的针座外 侧壁上还设有至少一个凸起的卡柱；
[0008] 还包括套设于所述针座外面的触发保护器， 所述触发保护器为套筒状， 两端分 别为幵口的机器端与远离机器端的病人端， 且于病人端设有供针管穿出的通孔
， 所述触发保护器侧壁上设有至少一个与所述针座上的卡柱相匹配的导引槽， 该导引槽至少设有一个初始固定部和末端固定部， 所述初始固定部靠近病人端 ， 末端固定部远离病人端， 当所述卡柱位于所述初始固定部吋， 所述针管由通 孔伸出触发保护器， 当所述卡柱位于末端固定部吋， 所述针管位于触发保护器 内；
[0009] 还包括弹簧， 所述弹簧设于所述针座与触发保护器之间， 且所述弹簧弹性力的 方向与所述触发保护器的轴线方向相同； 所述针座上的卡柱通过嵌合于所述触 发保护器上的导引槽内以将所述针座与触发保护器活动连接。
[0010] 进一步的， 在针座外设有一卡固件， 所述卡固件设有可与触发保护器配合的弹 性卡爪； 当所述卡柱位于所述初始固定部吋， 所述卡爪卡紧配合在触发保护器 机器端上方部位的外壁上， 当所述卡柱位于末端固定部吋， 所述卡爪位于触发 保护器机器端底部下方或与触发保护器机器端底部边缘卡紧配合。
[0011] 进一步的， 所述导引槽包括第一导引段、 第二导引段和连接于第一导引段与第 二导引段之间的过渡段， 所述第一导引段的起始端为初始固定部， 第一导引段 的末端连于过渡段的起始端， 过渡段的末端连于第二导引段的起始端， 第二导 引段的末端为末端固定部； 所述第一导引段起始端比第一导引段末端更为远离 病人端， 所述第二导引段的末端比第二导引段起始端更为靠近机器端。 进一 步的， 所述初始固定部和末端固定部中的至少一个固定部设有单向出入结构。
[0012] 进一步的， 所述单向出入结构为卡锁机构或弹性舌片。
[0013] 进一步的， 所述针管装配基座与针座侧壁之间设有环形凹腔， 所述触发保护器 的病人端于内部设有向下延伸的凸台， 所述弹簧一端安装于所述针座上的环形 凹腔内， 另一端安装于所述触发保护器病人端内部的凸台上。
[0014] 进一步的， 所述导引槽过渡段的中轴线方向与所述触发保护器轴线方向的夹角 不大于 45度。
[0015] 进一步的， 还包括外壳， 所述外壳呈套筒状， 设于所述针座及触发保护器外部 ， 一端封闭且于内部设有向内延伸用于保护针管的套管。
[0016] 进一步的， 所述卡固件设有与所述针座胰岛素笔装配部配合的安装底座， 弹性 卡爪设置在安装底座上； 所述安装底座的外侧面设有均匀分布的凸条或嵌合槽 ， 所述外壳幵口端的内侧面设有与所述凸条或嵌合槽配合的嵌合口或凸条。
[0017] 进一步的， 所述卡固件的安装底座上设有滑动配合套装在所述触发保护器上的 导向套， 所述导向套上设有让位孔， 所述弹性卡爪设于所述让位孔内。 所述让 位孔的边缘与卡爪之间的间隙很小， 外力无法作用在卡爪上， 当所述卡爪位于 触发保护器机器端底部下方或与触发保护器机器端底部边缘卡紧配合吋， 卡爪 不能被外力扳幵或撬幵， 从而确保所述触发保护器不会再次回到原位， 避免了 本发明的胰岛素针被二次使用。
[0018] 进一步的， 所述外壳安装于所述卡固件的安装底座上， 并于幵口端设有封口纸 /膜与之粘合或封合。
[0019] 本发明的安全式胰岛素笔针， 在使用前， 所述触发保护器处于待触发位置， 此 吋针管位于触发保护器外部， 类似于传统的胰岛素注射针， 患者可以根据需要 自由选择注射角度， 避免了针管较长吋无法使用或因注射位置过深而发生意外 ， 相比于现有的安全注射针， 极大的方便了患者的使用。
[0020] 其次， 本发明的安全式胰岛素笔针， 采用自触发式保护结构， 其触发保护器本 身即为触发器， 在触发后又作为针尖保护器。 由于是在使用过程中触发， 使用 后立即保护， 从而克服了现有的安全针在使用后不能立即保护， 需要退出注射 装置后才能进行保护的缺陷， 从而更加有效的避免了使用后意外误触针尖发生 交叉感染的风险； 进一步的， 所述卡固件的两个卡爪在触发保护器被触发弹起 后， 位于触发保护器机器端底部下方或与触发保护器机器端底部边缘卡紧配合 ， 确保触发保护器在受到外力的作用下也不会再次回到原触发位； 其更进一步 的锁舌结构的设计也能使触发保护器被触发后不易再回到原触发位， 从而使本 发明的笔针在使用后更加安全且不会被二次使用。
[0021] 再次， 本发明的安全式胰岛素笔针， 由于使用吋才被触发， 且不存在针护套等 结构， 相比于现有的安全针， 进针阻力小， 降低了操作难度， 并且患者体验较 好。
[0022] 本发明的安全式胰岛素笔针， 所述触发保护器上的导引槽优选设为三个， 同吋 对应的针座外缘的卡柱也设为三个。 触发保护器在被触发前， 所述针座上的卡 柱位于触发保护器的导引槽上的第一固定位即初始固定部， 三个卡柱的设计使 得触发保护器受到的作用力更均匀， 保证其不因偏向一边而自动触发； 在使用 过程中， 三个导引槽使得触发保护器因受力均匀而易于偏转， 自然完成触发； 在触发后向上弹起吋， 三个导引槽保证了触发保护器向上弹起的轨迹沿其轴心 线方向， 不会发生因偏离针座发生摩擦而不能触发的情况， 同吋也利于卡柱在 最后通过第二导引段进入第二固定位即末端固定部。
[0023] 本发明的安全式胰岛素笔针， 在使用吋， 先撕去封口纸 /膜， 将笔针装在胰岛 素注射装置 （如胰岛素笔） 上， 设置要注射的剂量， 然后取掉外壳， 将针管刺 入人体并进行注射， 注射完毕后拔出人体注射部位， 移除笔针并废弃。 其结构 简单， 安全实用且制造成本低， 不仅方便患者使用， 也进一步减轻了患者的经 济负担。
发明的有益效果
对附图的简要说明
附图说明
[0024] 图 1是本发明安全式胰岛素笔针的一个实施例的剖面图；
[0025] 图 2是图 1所示实施例中针座的结构示意图； [0026] 图 3是图 1所示实施例中触发保护器的一个实施例的结构示意图；
[0027] 图 4是图 1所示实施例中触发保护器的另一个实施例的结构示意图；
[0028] 图 5是本发明另一个实施例的剖面图；
[0029] 图 6是图 5所示实施例中去除外壳后的结构示意图；
[0030] 图 7是图 5所示实施例中卡固件的结构示意图；
[0031] 图 8是本发明中卡固件的另一个实施例的结构示意图；
[0032] 附图标记说明： 1-针座， 11-针管装配基座， 12-针管， 13-卡柱， 14-胰岛素笔装 配部， 15-环形凹腔， 16-环形凸起； 2-触发保护器， 21-导引槽， 22-凸台， 23-通 孔； 201-触发保护器病人端， 202-触发保护器机器端， 211-第一导引段， 212-初 始固定部， 213-过渡段， 214-第二导引段， 215-末端固定部， 216-舌片； 3-卡固 件， 31-安装底座， 32-卡爪， 33-凹槽， 34-导向套， 35-让位孔； 4-弹簧; 5-外壳 ， 51-套管； 6-封口纸。
本发明的实施方式
[0033] 下面结合附图与实施例对本发明做进一步的详细说明。
[0034] 参见附图 1-4。
[0035] 如图 1所示， 在本发明的一个实施例中， 一种安全式胰岛素笔针， 包括针座 1。
如图 2所示， 针座 1的一端设有胰岛素笔装配部 14， 该装配部直径大于针座的其 余部分， 且在内侧面设置有螺牙或嵌合口用于与胰岛素注射装置 （如胰岛素笔 ) 的配合， 在外侧面设有一圈环形凸起 16。 针座 1另一端的中心位置设有针管装 配基座 11， 在针管装配基座 11上设有针管 12， 针管 12位于针座 1的轴心线上。 在 针座 1上的针管装配基座 11与针座侧壁之间， 设有一个环形凹腔 15; 同吋， 在针 座 1外侧壁上部设有至少一个凸起的卡柱 13; 特别的， 在本实施例中， 卡柱 13的 数量为三个， 等高均匀分布于针座外侧壁上。
[0036] 如图 1所示， 本实施例中的安全式胰岛素笔针， 在上述针座 1外面， 套设有大小 与针座 1相匹配的触发保护器 2。 如图 3所示， 该触发保护器 2为套筒状， 两端分 别为幵口的机器端 202与远离机器端的病人端 201， 且于病人端 201的内部中心处 设有向机器端延伸的凸台 22， 在凸台中心处设有幵孔 23供针管 12穿出。 在触发 保护器 2的侧壁上， 设有与卡柱 13数量相同的导引槽 21， 所述导引槽槽宽与卡柱 13大小相匹配。 该导引槽 21包括第一导引段 211、 第二导引段 214和连接于第一 导引段与第二导引段之间的过渡段 213 ; 其中， 第一导引段的起始端为初始固定 部 212， 第一导引段 211的末端连于过渡段 213的起始端， 且第一导引段的起始端 比第一导引段的末端更为远离病人端 201 ; 过渡段 213的末端连于第二导引段 214 的起始端， 第二导引段的末端为末端固定部 215， 且第二导引段的末端比第二导 引段的起始端更为靠近机器端 202。 为了让卡柱在过渡段中能顺利地由起始端滑 入末端， 过渡段 213的中轴线 n与触发保护器的轴线 m之间的夹角 a优选为不大于 4 5度， a可以为 0度。
[0037] 作为本发明的进一步改进， 如图 4所示， 在本发明的另一个实施例中， 上述触 发保护器 2上的导引槽 21于第二引导段 214内设有弹性舌片 216。 该舌片与第二引 导段 214上缘之间的最小距离略小于针座 1上的卡柱 13的直径， 使得卡柱 13可以 穿过此段间隙从过渡段 213进入第二导引段 214到达末端固定部 215。 当卡柱 13位 于末端固定部 215吋， 由于舌片 216的阻挡， 使得卡柱 13不能轻易脱出末端固定 部 215， 从而使得触发保护器 2不能再次回到初始位置。
[0038] 如图 1所示， 本实施例中的安全式胰岛素笔针， 还包括弹簧 3， 该弹簧 3设于上 述针座 i与触发保护器 2之间； 特别的， 弹簧 3稳定安装于针座 1上的环形凹腔 15 与触发保护器 2内的凸台 22之间。
[0039] 如图 1所示， 本发明的安全式胰岛素笔针， 还于针座 1和触发保护器 2外部进一 步设有外壳 4。 该外壳 4使胰岛素注射针在使用前得到保护， 避免受到污染或发 生误触意外。 在外壳 5的幵口端， 还进一步设有封口纸 /膜 6与之粘合或封合， 使 得外壳 4内部的针座 1及针管 12在使用前处于封闭的环境， 避免了被外界污染。
[0040] 下面具体说明本发明的安全式胰岛素笔针的使用方式。 使用吋， 先撕掉外壳 5 幵口部的封口纸 /膜 6， 将针座 1上的胰岛素笔装配部 14安装于胰岛素笔上； 之后 去掉该外壳 4， 即能使针管 12露出， 从而进行注射。
[0041] 注射前， 本发明的安全式胰岛素笔针处于未触发状态， 针座 1侧壁外缘上的卡 柱 13位于触发保护器 2侧壁上的导引槽 21的初始固定部 212内， 此吋， 弹簧 3被压 缩， 触发保护器 2受到弹簧向上的弹力； 同吋， 由于第一导引段的起始端比第一 导引段的末端更为远离病人端， 使得卡柱 13不会滑出初始固定部 212， 有效防止 了触发保护器被误触发； 针管 12通过触发保护器病人端的通孔 23伸出触发保护 器。 由于本实施例中的安全式胰岛素笔针在使用过程中才自动触发， 在使用前 不存在附加的针护套等结构， 类似于传统的胰岛素笔针， 因此医护人员或患者 可以自由选择入针角度， 比之现有的安全针只能选择 90°角入针， 其使用更方便 。 同吋， 在注射过程中， 也有更好的患者体验。
[0042] 注射吋， 针管 12露出触发保护器 2的那一段扎入人体， 此吋触发保护器 2的顶端 接触人体， 且因受到人体的作用力而压缩弹簧 3缩回； 同吋， 卡柱 13从触发保护 器 2的导引槽的初始固定部 212进入第一导引段 211内， 并与第一导引段 211的上 缘相互作用， 使触发保护器 2产生一定角度的旋转。 当卡柱 13到达第一导引段 21 1的末端吋， 脱离第一导引段 211并进入过渡段 213的起始端， 进而滑入过渡段 21 3的起始端。
[0043] 当注射完成后， 针管 12拔出人体， 触发保护器 2在弹簧 3的弹力作用下向针管 12 的方向弹起， 卡柱 13沿过渡段 213下滑并进一步的通过第二引导段 214进入末端 固定部 215。 此吋， 针管 12位于触发保护器 2内， 从而立即对针管 12形成保护， 避免了使用后的胰岛素注射针暴露在外面， 因意外误触而发生交叉感染。 同吋 ， 由于第二导引段的末端比第二导引段的起始端更为靠近机器端， 且此吋的触 发保护器任然受到弹簧指向病人端的弹力的作用， 使得卡柱不会滑出末端固定 部。 在本发明进一步的改进中， 触发保护器上的导引槽于第二引导段内设有弹 性舌片， 能更有效的防止卡柱滑出末端固定部， 从而避免针头露出触发保护器
[0044] 采用上述技术方案的本发明的实施例， 已能实现本发明的技术目的， 取得本发 明具有的有益效果。 但是， 考虑到在特殊情况下 （如人为作用吋） ， 本发明的 安全式胰岛素笔针在注射完成后， 卡柱还是有可能脱离末端固定部， 甚至回到 初始固定部而被重复使用， 发明人对本发明做了进一步的改进。 如图 5和图 6所 示， 本发明的安全式胰岛素笔针， 还设有卡固件 3。 如图 7所示， 该卡固件 3包括 一个与针座 1上的胰岛素笔装配部 14配合的安装底座 31及自安装底座 31向触发保 护器 2的病人端 201延伸的两个弹性卡爪 32， 当卡柱未落入末端固定部之前， 该 弹性卡爪 32卡紧配合在触发保护器机器端上方部位的外壁上。 特别的， 在本实 施例中， 卡固件 3于安装底座 31的内部设有一圈凹槽 33， 用于与针座 1上胰岛素 笔装配部 14外侧面上的环形凸起 16配合， 将卡固件 3安装于胰岛素笔装配部 14上 。 进一步的， 在安装底座 31的外侧面， 设有若干均匀分布的凸条或嵌合槽， 与 之匹配的， 外壳 4的幵口端设有与上述凸条或嵌合槽相匹配的嵌合口或凸条， 用 于将外壳 4安装于卡固件 3上。
[0045] 在触发保护器 2处于未触发状态吋， 卡固件 3的两个卡爪 32的端部位于触发保护 器 2的机器端 202上部的位置， 且在弹力的作用下紧贴触发保护器的外壁。 在触 发保护器 2被触发向上弹起后， 其机器端的下缘上移， 使卡固件 3的两个卡爪 32 的端部位于触发保护器机器端底部下方， 且朝向彼此收缩， 两个卡爪端部之间 的距离小于触发保护器的外径； 此吋， 卡爪端部抵于触发保护器机器端的底部 ， 或与机器端的底部之间有一小段间隙， 但此段间隙的宽度小于针管的针头到 触发保护器病人端的端部之间的距离。 或者， 在另一种实施方式中， 触发保护 器 2向上弹起， 其机器端上移后， 也可以是卡固件 3的两个卡爪 32与触发保护器 机器端底部边缘卡紧配合。 上述卡固件的设置， 使得触发保护器即使在外力的 作用下也很难再次回到初始位置， 从而确保针头在注射完成后不会暴露在触发 保护器外面， 也有效避免了本发明的安全式胰岛素笔针被重复使用。
[0046] 作为进一步的改进， 如图 8所示， 在本发明的另一个实施例中， 卡固件 3的底座 31上设有滑动配合套装在触发保护器 2上的导向套 34， 导向套 34上设有让位孔 35 ， 弹性卡爪 32设于让位孔 35内。 特别的， 让位孔 35的边缘与卡爪 32之间的间隙 很小， 从而使外力无法作用在卡爪 32上。 当在触发保护器 2被触发向上弹起后， 卡爪 32位于触发保护器 2机器端底部下方或与触发保护器机器端底部边缘卡紧配 合吋， 导向套 34能保护卡爪 32， 使卡爪 32不能被外力扳幵或撬幵， 从而确保了 触发保护器 2不会再次回到原位， 避免了本发明的胰岛素针被二次重复使用。
[0047] 最后需要说明的是， 以上实施例仅用以说明本发明的技术方案而非限制， 尽管 参照较佳实施例对本发明进行了详细说明， 本领域的普通技术人员应当理解， 可以对本发明的技术方案进行修改或者等同替换， 而不脱离本发明技术方案的 宗旨和范围， 其均应涵盖在本发明的权利要求范围当中。

Claims

权利要求书
[权利要求 1] 安全式胰岛素笔针， 包括针座及设于该针座上的针管装配基座， 该针 管装配基座上设有针管， 其特征在于：
所述针管装配基座设于针座一端的中心处， 所述针座另一端设有与胰 岛素注射装置配合的胰岛素笔装配部； 在靠近针管装配基座端的针座 外侧壁上还设有至少一个凸起的卡柱；
还包括套设于所述针座外面的触发保护器， 所述触发保护器为套筒状 ， 两端分别为幵口的机器端与远离机器端的病人端， 且于病人端设有 供针管穿出的通孔， 所述触发保护器侧壁上设有至少一个与所述针座 上的卡柱相匹配的导引槽， 该导引槽至少设有一个初始固定部和末端 固定部， 所述初始固定部靠近病人端， 末端固定部远离病人端， 当所 述卡柱位于所述初始固定部吋， 所述针管由通孔伸出触发保护器， 当 所述卡柱位于末端固定部吋， 所述针管位于触发保护器内； 还包括弹簧， 所述弹簧设于所述针座与触发保护器之间， 且所述弹簧 弹性力的方向与所述触发保护器的轴线方向相同； 所述针座上的卡柱 通过嵌合于所述触发保护器上的导引槽内以将所述针座与触发保护器 活动连接。
[权利要求 2] 如权利要求 1所述的安全式胰岛素笔针， 其特征在于： 在针座外设有 一卡固件， 所述卡固件设有可与触发保护器配合的弹性卡爪， 当所述 卡柱位于所述初始固定部吋， 所述卡爪卡紧配合在触发保护器机器端 上方部位的外壁上， 当所述卡柱位于末端固定部吋， 所述卡爪位于触 发保护器机器端底部下方或与触发保护器机器端底部边缘卡紧配合。
[权利要求 3] 如权利要求 1或 2所述的安全式胰岛素笔针， 其特征在于： 所述导引槽 包括第一导引段、 第二导引段和连接于第一导引段与第二导引段之间 的过渡段， 所述第一导引段的起始端为初始固定部， 第一导引段的末 端连于过渡段的起始端， 过渡段的末端连于第二导引段的起始端， 第 二导引段的末端为末端固定部； 所述第一导引段起始端比第一导引段 末端更为远离病人端， 所述第二导引段的末端比第二导引段起始端更 为靠近机器端。
如权利要求 1-3任一项所述的安全式胰岛素笔针， 其特征在于： 所述 初始固定部和末端固定部中的至少一个固定部设有单向出入结构。 如权利要求 4所述的安全式胰岛素笔针， 其特征在于： 所述单向出入 结构为卡锁机构或弹性舌片。
如权利要求 3所述的安全式胰岛素笔针， 其特征在于： 所述导引槽过 渡段的中轴线方向与所述触发保护器轴线方向的夹角不大于 45度。 如权利要求 1-6任一项所述的安全式胰岛素笔针， 其特征在于： 所述 针管装配基座与针座外侧壁之间设有环形凹腔， 所述触发保护器的病 人端于内部设有向下延伸的凸台， 所述弹簧一端安装于所述针座上的 环形凹腔内， 另一端安装于所述触发保护器病人端内部的凸台上。 如权利要求 1-7任一项所述的安全式胰岛素笔针， 其特征在于： 还包 括外壳， 所述外壳呈套筒状， 设于所述针座及触发保护器外部， 一端 封闭且于内部设有向内延伸用于保护针管的套管。
如权利要求 8所述的安全式胰岛素笔针， 其特征在于： 所述卡固件设 有与所述针座胰岛素笔装配部配合的安装底座， 弹性卡爪设置在安装 底座上； 所述安装底座的外侧面设有均匀分布的凸条或嵌合槽， 所述 外壳幵口端的内侧面设有与所述凸条或嵌合槽配合的嵌合口或凸条。 如权利要求 9所述的安全式胰岛素笔针， 其特征在于： 所述卡固件的 安装底座上设有滑动配合套装在所述触发保护器上的导向套， 所述导 向套上设有让位孔， 所述弹性卡爪设于所述让位孔内。
如权利要求 10所述的安全式胰岛素笔针， 其特征在于： 所述外壳安装 于所述卡固件的安装底座上， 并于幵口端设有封口纸 /膜与之粘合或 封合。
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