WO2016173367A1 - 一次性安全型胰岛素注射针头 - Google Patents

一次性安全型胰岛素注射针头 Download PDF

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Publication number
WO2016173367A1
WO2016173367A1 PCT/CN2016/078038 CN2016078038W WO2016173367A1 WO 2016173367 A1 WO2016173367 A1 WO 2016173367A1 CN 2016078038 W CN2016078038 W CN 2016078038W WO 2016173367 A1 WO2016173367 A1 WO 2016173367A1
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WO
WIPO (PCT)
Prior art keywords
main casing
needle
seat
outer sheath
sleeve
Prior art date
Application number
PCT/CN2016/078038
Other languages
English (en)
French (fr)
Inventor
施国平
霍斯特曼安东尼·斯科特
Original Assignee
苏州施莱医疗器械有限公司
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 苏州施莱医疗器械有限公司 filed Critical 苏州施莱医疗器械有限公司
Publication of WO2016173367A1 publication Critical patent/WO2016173367A1/zh

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    • 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
    • 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

Definitions

  • the present invention relates to a medical insulin injection tool, and more particularly to a disposable safe insulin injection needle.
  • a medical insulin injection tool and more particularly to a disposable safe insulin injection needle.
  • Such an injection needle can be used with an insulin pen for self-administration or other administration, wherein the insulin pen can be reused and the injection needle is a single-use needle.
  • Diabetes is a metabolic disease characterized by hyperglycemia. There is no cure at present, but injecting insulin into patients can effectively control the disease.
  • the insulin injection needle of the present invention is an injection tool for use with an insulin pen, wherein the insulin pen carries a prescribed amount of insulin liquid medicine, which can be reused, and the injection needle is a kind. Disposable needle with safety device.
  • a needle body for injecting insulin and a needle holder for fixing the needle body
  • a main housing for connecting to an insulin pen
  • An outer sheath for protecting the entire injection needle which is not shown in the drawings of the above two patents, but which can be seen in actual products and is generally indispensable. In practical applications, the outer sheath is set on the outer side of the main casing. After the injection needle is mounted to the insulin pen in use, the outer sheath can be manually removed, and then the skin is injected into the human skin to inject insulin.
  • the outer sheath and the main casing are sleeved, and there is a safety hazard from the protection function of the outer sheath, that is, when the user or other person accidentally pulls out the outer sheath, the injection needle is polluted and The risk of stabbing others;
  • the present invention improves upon the above-described prior art from the perspective of safety and convenience of use of an injection needle to overcome the drawbacks of the prior art.
  • the present invention provides a disposable safety insulin injection needle whose purpose is to solve the safety and convenience problems existing in the prior art use described above.
  • a disposable safety insulin injection needle comprising:
  • a needle body having an injection section extending toward the front end, a connecting section extending toward the rear end direction, and a fixing section between the injection section and the connecting section;
  • the fixed section of the needle body is fixed on the needle seat, the injection section of the needle body protrudes from the front end of the needle seat, and the connecting section of the needle body protrudes from the rear end of the needle seat;
  • the main housing is a cylindrical structure, in the assembled state, the needle seat and the needle body are located in the main housing, and the rear end of the main housing is used for connecting the insulin pen;
  • the outer sheath is a sleeve structure, and the outer sheath is sleeved outside the main casing in an assembled state before use for protecting the whole of the injection needle;
  • the needle seat is provided with a seat plate, the outer edge of the seat plate is matched with the inner edge of the main casing, and the outer edge of the corresponding seat plate is axially spaced apart from the inner edge of the main casing to provide a first positioning position and a a positioning position in which an axial thrust generated by the insulin pen head against the needle seat forces the seat pan to move axially forward from the first positioning position in the main housing during installation of the injection needle into the insulin pen a second positioning position, so that the needle seat and the main housing form a sliding positioning connection relationship; in the first positioning position, the outer edge of the seat plate and the inner edge of the main housing are matched by the first positioning structure, The outer edge of the seat plate and the inner edge of the main casing are matched by the second positioning structure; the first positioning structure adopts a concave-convex positioning structure, an elastic positioning structure or a friction positioning structure; and the second positioning structure adopts a concave-convex Positioning structure, elastic positioning structure, friction positioning structure, card locking position
  • the side wall of the main casing cylinder is provided with a bayonet, and the bayonet is arranged corresponding to the second positioning position in the axial direction of the main casing, and the bayonet is a through hole penetrating between the inner and outer walls of the main casing, corresponding to the through hole
  • the hole is provided with a block on the inner wall of the outer sheath sleeve, and the card block is inserted into the bayonet and protrudes into the main casing in the state of the outer sheath set main casing, so that the outer sheath is lockedly connected with the main casing;
  • the outer edge of the seat plate pushes up the block on the outer sheath, so that the outer sheath is deformed, and finally the block and the bayonet are buckled, thereby realizing the outer sheath and the main shell.
  • the body is unlocked, and the outer sheath is allowed to be removed in this state.
  • the "front” in the “front end”, “forward”, “front and rear”, “front”, “front”, “front end” refers to the disposable safe insulin of the present invention.
  • the "back end”, “front and rear”, “Back” in “backward”, “back”, and “rear” refers to the opposite direction of "front”.
  • an inwardly protruding rib may be arranged on the inner wall of the sleeve of the outer sheath, and the outer sheath is set in the main casing. After the outer side, a gap is provided between the inner wall of the outer sheath and the outer wall of the main casing for deformation of the outer sheath.
  • a chute extending in the direction of the front end may be provided at the bayonet of the main casing.
  • the concave-convex positioning structure is formed by a groove provided in a circumferential direction of the outer edge of the seat plate and a convex rib provided on an inner edge of the main casing.
  • the elastic positioning structure is formed by the elastic bead pin and the recess, and one of the elastic bead pin and the recess is disposed on the outer edge of the seat pan, and the other is disposed on the inner edge of the main casing.
  • the friction positioning structure is formed by frictional engagement between the outer edge of the seat plate and the inner edge of the main housing.
  • the card locking position structure is formed by the outer edge of the seat plate and the front and rear end faces being engaged with the card slots provided on the inner edge of the main casing.
  • the end face abutment positioning structure is formed by abutting the front end surface of the outer edge of the seat plate against the inner end surface of the inner edge of the main casing.
  • the meaning of the word "corresponding" in the “mounting of the bayonet in the axial direction of the main casing corresponding to the second positioning position” includes three cases: the first is that the bayonet is located in the axial direction of the main casing.
  • the second position is that the bayonet is located in the vicinity of the second positioning position in the axial direction of the main casing and on the front side; and the third is that the bayonet is located in the vicinity of the second positioning position in the axial direction of the main casing and on the rear side.
  • the design principle and effect of the present invention are:
  • the present invention relates to a disposable safety insulin injection needle that needs to be used in conjunction with an insulin pen.
  • the technical idea of the present invention is:
  • the locking structure is added on the basis of the original sleeve and the original sleeve of the main casing, and the reliability problem of the injection needle is protected by the outer sheath sleeve to ensure that the outer sheath is not removed before the injection needle is officially used. Improve safety;
  • connection between the needle holder for fixing the needle body and the main housing is designed to be slidingly positioned, that is, the axial thrust of the needle holder is forced by the insulin pen head when the injection needle is mounted, and the seat on the needle holder is forced. Stopping the disk from the first positioning position to the second positioning position, thereby associating the information of whether the injection needle is in place with the moving position of the seat disk on the needle seat in the main housing;
  • the present invention fully exerts the role and effectiveness of the outer sheath in terms of safety protection from the perspective of product design. And the reasonable use of the axial thrust and position of the injection needle to achieve the purpose of automatic unlocking of the outer sheath. Its technical concept is clever, the design scheme is reasonable, with outstanding substantive features and significant technological progress, fully reflecting the safety and convenience of the use of injection needles.
  • FIG. 1 is a perspective view of a disposable safety insulin injection needle according to an embodiment of the present invention.
  • FIG. 2 is an exploded perspective view of a disposable safety insulin injection needle according to an embodiment of the present invention
  • Figure 3 is a perspective view of a tail cap according to an embodiment of the present invention.
  • Figure 4 is a perspective view of a needle holder and a needle body according to an embodiment of the present invention.
  • Figure 5 is a perspective view, partly in section, of the main casing of the embodiment of the present invention.
  • Figure 6 is a perspective view of a front sleeve of an embodiment of the present invention.
  • Figure 7 is a perspective view, partly in section, of the front sleeve of the embodiment of the present invention.
  • Figure 8 is a perspective view of a trigger tube according to an embodiment of the present invention.
  • Figure 9 is a perspective view showing a partial cross section of a trigger tube according to an embodiment of the present invention.
  • Figure 10 is a perspective view, partly in section, of an embodiment of the present invention.
  • Figure 11 is an end elevational view of a disposable safety insulin injection needle with an A-A cross-sectional mark in accordance with an embodiment of the present invention
  • Figure 12 is an end elevational view of a disposable safety insulin injection needle with a B-B cross-sectional mark in accordance with an embodiment of the present invention
  • Figure 13 is an end elevational view of a disposable safety insulin injection needle with a C-C cross-sectional mark in accordance with an embodiment of the present invention
  • Figure 14 is a cross-sectional view taken along line A-A of the embodiment before use in the embodiment of the present invention.
  • Figure 15 is a cross-sectional view taken along line C-C of the embodiment before use in the embodiment of the present invention.
  • Figure 16 is a cross-sectional view of the A-A after the tail cover is hidden in the state before use according to the embodiment of the present invention
  • Figure 17 is a cross-sectional view of the A-A of the embodiment of the present invention when the insulin pen is screwed into the injection needle using the first stage;
  • Figure 18 is a cross-sectional view along line A-A of the embodiment of the present invention when the second stage insulin pen is used to continue to be screwed into the injection needle;
  • Figure 19 is a cross-sectional view taken along the line A-A of the embodiment of the present invention when the third stage insulin pen is used to continue to be screwed into the injection needle;
  • Figure 20 is a cross-sectional view taken along line B-B of the embodiment of the present invention when the third stage insulin pen is used to continue to be screwed into the injection needle;
  • Figure 21 is a cross-sectional view taken along line C-C of the embodiment of the present invention when the fourth stage insulin pen is used to continue to be screwed into the injection needle;
  • Figure 22 is a cross-sectional view taken along line A-A of the embodiment of the present invention when the fourth stage insulin pen is used to continue to be screwed into the injection needle;
  • Figure 23 is a cross-sectional view taken along line B-B of the embodiment of the present invention when the fourth stage insulin pen is used to continue to be screwed into the injection needle;
  • Figure 24 is a perspective view showing the fifth stage of the removal of the sheath according to the embodiment of the present invention.
  • Figure 25 is a cross-sectional view along line A-A of the fifth stage of the present invention using the fifth embodiment
  • Figure 26 is a cross-sectional view along line A-A of the embodiment of the present invention when the sixth stage needle is used to start piercing human skin;
  • Figure 27 is a cross-sectional view along line A-A of the embodiment of the present invention when the seventh stage needle is used to penetrate human skin;
  • Figure 28 is a cross-sectional view of the A-A of the embodiment of the present invention using the eighth stage needle to completely penetrate the human skin and inject insulin.
  • Figure 29 is a cross-sectional view showing the A-A of the ninth stage after the injection of the insulin needle from the skin is carried out according to an embodiment of the present invention.
  • Figure 30 is a cross-sectional view taken along line B-B of the ninth stage after the injection of the insulin needle from the skin is carried out according to an embodiment of the present invention
  • Figure 31 is a cross-sectional view taken along the line A-A of the embodiment of the present invention when the injection needle is rotated using the tenth stage insulin pen;
  • Figure 32 is a cross-sectional view taken along line A-A of the embodiment of the present invention.
  • Figure 33 is a perspective view of the front sleeve of the present invention for displaying a "station";
  • Figure 34 is a perspective view showing the trigger tube of the present invention as a display "block";
  • Figure 35 is a cross-sectional view taken along line B-B showing the cooperation of the "station” and the "stop”;
  • Figure 36 is a perspective view of an insulin injection needle according to another embodiment of the present invention.
  • Figure 37 is a perspective view of a needle hub in another embodiment of the present invention.
  • Figure 38 is a cross-sectional view taken along the line A-A in a state before use according to another embodiment of the present invention.
  • Figure 39 is a cross-sectional view taken along line B-B of the embodiment before use according to another embodiment of the present invention.
  • Figure 40 is a cross-sectional view along line A-A of the embodiment of the present invention in which the outer sheath is removed;
  • Figure 41 is a cross-sectional view along line B-B of the embodiment of the present invention when the outer sheath is removed;
  • Figure 42 is a cross-sectional view taken along line A-A of the other embodiment of the present invention.
  • Figure 43 is a cross-sectional view taken along line B-B of the embodiment of the present invention in use.
  • tail cover 11. contact hook; 12. bevel; 13. stop; 14. sharp corner; 15. cap; 16. front leg;
  • Needle seat 21. Groove; 22. Convex; 23. Seat; 24. Seatpost;
  • main housing 31. first cassette step; 32. evasion slot; 33. rib; 34. card slot; 35. second card step; 36. anti-back groove; 37. ;38. bayonet; 39. chute;
  • Trigger tube 51. recess; 52. plug; 53.
  • outer sheath 81. card block; 82. ribs.
  • Example 1 Disposable Safe Insulin Injection Needle (with Front Tip Protection and Rear Tip Protection)
  • the injection needle is composed of a needle body 6, a needle holder 2, a main casing 3, an outer sheath 8, a tail cover 1, a front sleeve 4, and a touch.
  • the hair tube 5 and the spring 7 (see Fig. 2).
  • the needle body 6 is for injecting an insulin needle, the needle body 6 has an injection section extending toward the front end, a connecting section extending toward the rear end direction, and a fixed section between the injection section and the connecting section. .
  • the needle holder 2 is used for fixing the needle body 6 (see FIG. 4), and the fixing portion of the needle body 6 is fixed on the needle holder 2.
  • the injection section of the needle body 6 protrudes from the front end of the needle holder 2, and the connecting portion of the needle body 6 Extending from the rear end of the hub 2.
  • the needle seat 2 is composed of a seat pan 23 and a seat post 24.
  • the seat post 24 is located at the front end of the seat pan 23 and is fixedly connected with the seat pan 23.
  • the seat post 24 is provided with a convex portion 22, and the seat plate 23 is provided with two retaining slots. 25, a groove 21 is provided in the circumferential direction of the outer edge of the seat pan 23.
  • the main casing 3 is for accommodating the outer casing 8 except for the sheath 8 (see Fig. 5).
  • the main casing 3 has a cylindrical structure in which components such as the hub 2 and the needle 6 are located in the assembled state.
  • a first latching step 31 is disposed in a middle portion of the inner wall of the main housing 3
  • a second latching step 35 is disposed at a front end of the inner wall of the main housing 3
  • a third latching step is disposed at a rear portion of the inner wall of the main housing 3. 37.
  • the front wall of the main casing 3 is provided with an anti-retracting groove 36.
  • the front part of the inner wall of the main casing 3 is further provided with a escaping groove 32.
  • the inner edge of the main casing 3 is provided with a rib 33 and a card slot 34.
  • the rib 33 is located at a first positioning position of the main housing 3 in the axial direction
  • the slot 34 is located at a second positioning position of the main housing 3 in the axial direction. If the rear end of the main housing 3 is used as a reference, the first positioning position is to the main position.
  • the distance of the rear end of the housing 3 is smaller than the distance from the second positioning position to the rear end of the main housing 3.
  • the side wall of the main casing 3 is provided with a bayonet 38.
  • the bayonet 38 is axially located at a second positioning position of the main casing 3, and the bayonet 38 is a through hole extending through the inner and outer walls of the main casing 3.
  • the bayonet 38 is provided with a sliding slot 39 extending in the direction of the front end (to facilitate the separation of the latch 81 from the bayonet 38).
  • the rear end of the main casing 3 is used for connecting an insulin pen, and the connection structure may be a screw connection method, a plug connection method, a plug-and-spin rotation connection method, or the like.
  • the main housing 3 of Fig. 5 shows a threaded connection.
  • the outer sheath 8 is used to protect the entire injection needle (see Figure 10).
  • the outer sheath 8 is of a sleeve structure, and the outer sheath 8 is fitted outside the main casing 3 in an assembled state before use.
  • the inner wall of the sleeve of the outer sheath 8 is provided with a latching block 81.
  • the latching block 81 corresponds in position to the bayonet 38 on the side wall of the tubular body of the main casing 3, and the latching block 81 is in the state of the outer sheath 8 in the state of the main casing 3.
  • the card insertion opening 38 extends into the main casing 3 to lock the outer casing 8 to the main casing 3.
  • the inner wall of the sleeve of the outer sheath 8 is provided with an inwardly projecting rib 82 in the axial direction.
  • the tail cap 1 is used to protect the connecting section of the needle body 6 (see Fig. 3).
  • the tail cap 1 is composed of a cap 15 and two front legs 16.
  • the cap 15 is an end cap or an annular body, and the center of the cap 15 is provided with a pinhole hole 17 for inserting only the connecting portion of the needle body 6, so that the axis of the pinhole 17 is parallel to the axis of the main casing 3, and the two front legs 16 are fixedly connected.
  • each front leg 16 On the front end of the cap 15, and symmetrically arranged with respect to the axis of the pinhole 17, the inner side of each front leg 16 is provided with a bevel 12 at the root position and an inwardly extending stop 13 at the central position, at the end The contact hooks 11 are provided at the position; the outer side of each of the front legs 16 is provided with a pointed latch 14 at a central position.
  • the front sleeve 4 is used to protect the injection section of the needle body 6 after use (see Figures 6 and 7).
  • the main structure of the front sleeve 4 is a tubular body, and the front end of the front sleeve 4 is provided with an inner end surface 44; the rear end of the front sleeve 4 is provided with a resilient latch 41 extending rearward and an elastic tail 43 extending rearward.
  • the elastic latch 41 and the elastic tail 43 are circumferentially staggered in the front sleeve 4; the outer side of the front sleeve 4 is provided with an outwardly extending projection 42, and the projection 42 and the elastic latch 41 are circumferentially of the front sleeve 4.
  • the projection 42 is provided with an inclined surface 45 on the side of the elastic latch 41.
  • the trigger tube 5 is used to protect the injection section of the needle body 6 (see Figs. 8 and 9).
  • the main structure of the trigger tube 5 is a tube body.
  • the rear end of the trigger tube 5 is provided with two plugs 52 extending rearward, and the plug 52 is provided with a barb.
  • the trigger tube 5 is provided with a recess 51 in the tube body.
  • the spring 7 is used to push the front sleeve 4 and the tail cap 1.
  • a locking structure is added on the basis of the original sleeve 8 and the main casing 3 being originally socketed. That is, a bayonet 38 is disposed on the side wall of the main body 3 cylinder, and the bayonet 38 is disposed on the inner wall of the outer sheath 8 sleeve, and the outer block 8 is provided with the main casing 3 81 snaps into the bayonet 38 and extends into the main housing 3 to lock the outer sheath 8 to the main housing 3.
  • this structural feature solves the problem of reliability and safety of the outer sheath 8 to protect the injection needle, and ensures that the outer sheath 8 will not be removed before the injection needle is officially used.
  • the needle holder 2 for fixing the needle body 6 and the main casing 3 are designed to be in a slidingly positioned connection relationship. That is, the outer edge of the upper seat pan 23 of the needle seat 2 cooperates with the inner edge of the main casing 3, and the outer edge of the corresponding seat plate 23 is axially spaced apart from the inner edge of the main casing 3 to be provided with a first positioning position and a second positioning position.
  • the axial thrust generated by the insulin pen head on the needle hub 2 forces the seat pan 23 to axially forward from the first positioning position within the main casing 3. Moving to the second positioning position, the needle seat 2 and the main housing 3 form a sliding positioning connection relationship.
  • the first positioning position the outer edge of the seat plate 23 is engaged with the inner edge of the main casing 3 by a first positioning structure.
  • the second positioning position the outer edge of the seat plate 23 and the inner edge of the main casing 3 pass the second positioning.
  • the structure is matched.
  • the first set The bit structure is a concave-convex positioning structure which is specifically formed by a groove 21 provided in the circumferential direction of the outer edge of the seat disk 23 and a rib 33 provided on the inner edge of the main casing 3.
  • the second positioning structure is a card locking position structure.
  • the card locking position structure is specifically formed by the outer edge of the seat plate 23 and the front and rear side end faces being engaged with the card slots 34 provided on the inner edge of the main casing 3.
  • connection relationship is to utilize the axial thrust of the insulin pen head against the needle hub 2 when the injection needle is mounted, forcing the seat pan 23 on the needle hub 2 to move forward from the first positioning position to the second positioning position.
  • the information of stopping, thereby mounting the injection needle in position is associated with the position of movement of the seat pan 23 on the hub 2 within the main housing 3.
  • the bayonet 38 on the main casing 3 is disposed at a second axially positioned position of the main casing 3.
  • the outer edge of the seat plate 23 pushes up the block 81 on the outer sheath 8 to deform the outer sheath 8, eventually resulting in the block 81 and the bayonet 38.
  • the tripping is performed to unlock the outer casing 8 and the main casing 3, and the outer casing 8 is allowed to be removed in this state.
  • the positional relationship feature associates the information of whether the injection needle is in place through the position of movement of the seat pan 23 within the main housing 3 with whether the outer sheath 8 is unlocked, and ultimately whether the outer sheath 8 and the insulin pen are allowed to be removed.
  • the state in which the injection needle is ready for injection is associated, thereby greatly improving the safety and convenience of the use of the injection needle.
  • the outer sheath 8 in the assembled state before use, the outer sheath 8 is fitted outside the main casing 3, and the block 81 on the outer sheath 8 is snapped into the bayonet 38 of the main casing 3 and extends into the main In the casing 3, the outer sheath 8 is lockedly connected with the main casing 3; the needle seat 2 and the needle body 6 are located in the main casing 3, and the seat pan 23 on the needle seat 2 is in the first positioning position in the main casing 3. In the first positioning position, the groove 21 in the circumferential direction of the outer edge of the seat plate 23 cooperates with the rib 33 on the inner edge of the main casing 3 to form a concave-convex positioning structure (see FIG.
  • the tail cover 1 is located at the rear end of the main casing 3. Inside, the cap 15 on the tail cap 1 is located behind the seat pan 23 for protecting the connecting section of the needle body 6 (see Figs. 14 and 15), and the two front legs 16 on the tail cap 1 pass through two of the seat pans 23
  • the retaining groove 25 is extended forward (see FIGS. 14 and 15); the front sleeve 4 is located in the main casing 3, and the elastic latch 41 on the front sleeve 4 is firstly caught on the main casing 3. On the step 31, the front sleeve 4 is restricted from moving forward relative to the main casing 3 (see FIG.
  • the trigger tube 5 is located in the front end of the main casing 3 and extends outside the front end.
  • the rear portion of the trigger tube 5 is fitted on the seat post 24 of the needle holder 2, and the rear portion of the trigger tube 5 is located in the front sleeve 4, and the front end of the trigger tube 5 is approached.
  • the recess 51 on the trigger tube 5 is caught on the convex portion 22 of the seat post 24 to form a position (see Figs. 15 and 16); the spring 7 is abutted against the tail cover at one end.
  • the two front legs 16 are on the stop 13 and the other end abuts against the inner end face 44 of the front sleeve 4 (see Figure 14).
  • the first stage is a first stage
  • Figure 17 shows the state of the first phase.
  • the user screwes the insulin pen head into the injection needle of this embodiment.
  • the head of the insulin pen pushes the tail cap 1 forward, and the arrow in Fig. 17 indicates the thrust generated by the head of the insulin pen, while the contact hook 11 of the tail cap 1 is topped by the inclined surface 45 on the projection 42 of the front sleeve 4.
  • Figure 18 shows the state of the second phase. As can be seen from Fig. 18, in this state, the insulin pen continues to be screwed into the injection needle, and the contact hook 11 of the tail cap 1 passes over the projection 42 of the front sleeve 4, while the inclined surface 12 of the tail cover 1 presses the front sleeve 4 The upper elastic click 41 is bent inward.
  • the third stage is the third stage.
  • the latch 81 on the outer sheath 8 snaps into the bayonet 38 of the main casing 3 and projects into the main casing 3, and the dial 23 on the hub 2 remains In the first positioning position, the tail cap 1 gradually contacts the seat pan 23 on the needle hub 2.
  • 21, 22, and 23 show the state of the fourth stage.
  • the insulin pen continues to be screwed into the injection needle, and the cap 15 on the tail cap 1 abuts against the seat pan 23 of the hub 2 and pushes the seat pan 23 forward from the first positioning position to the second positioning position (see FIG. 21), in the second positioning position, the outer edge of the seat pan 23 and the front and rear end faces are engaged in the card slot 34 on the inner edge of the main casing 3 to form a card locking position structure, and the seat pan 23 is locked in the second positioning position. You can't move forward or move backwards.
  • 25 and 26 show the state of the fifth stage. In this state, the outer sheath 8 is removed by hand.
  • Fig. 26 shows the state of the sixth stage.
  • the trigger tube 5 is brought into contact with human skin, and the needle body 6 starts to penetrate into the human skin.
  • the trigger tube 5 moves backward, at which time the plug 52 on the trigger tube 5 lifts up the stopper 13 on the tail cover 1, forcing the contact hook 11 of the tail cover 1 and the front
  • the projections 42 of the sleeve 4 are gradually separated.
  • the seventh stage is the seventh stage.
  • Fig. 27 shows the state of the seventh stage.
  • the trigger tube 5 continues to move backward until the contact hook 11 is completely separated from the projection 42 and the front sleeve 4 is moved forward by the spring 7 and protrudes from the front end of the main casing 3, the front sleeve Front of tube 4 The end face is blocked by the human skin, and is flush with the front end surface of the trigger tube 5 and moves together.
  • Fig. 28 shows the state of the eighth stage. In this state, the needle 6 is completely injected into the human skin and begins to inject insulin.
  • the ninth stage is the eighth stage.
  • 29 and 30 show the state of the ninth stage.
  • the injection needle is pulled out from the human skin, at which time the front sleeve 4 is pushed out of the front end of the main casing 3 by the spring 7 until the projection 42 on the front sleeve 4 is second by the main casing 3.
  • the cassette step 35 intercepts and stops extending forward, at which time the front sleeve 4 serves to protect the injection section of the needle body 6 (see Fig. 29).
  • the elastic tail 43 of the front sleeve 4 is extended and then snapped into the anti-retraction groove 36 of the main casing 3 to form a limit for the rear sleeve 4 to move backward, preventing the front sleeve 4 from retreating (see FIG. 30). ).
  • Fig. 31 shows the state of the tenth stage.
  • the insulin pen is screwed out of the injection needle, and the tail cap 1 is moved backward by the spring 7, while the two stoppers 13 on the tail cap 1 clamp the plug 52 on the trigger tube 5, and trigger the trigger.
  • the tube 5 moves backward.
  • Fig. 32 shows the state after use.
  • the trigger tube 5 continues to move backward until the front end of the seat post 24 on the needle hub 2 is lowered by the front inner end surface of the trigger tube 5 to stop.
  • the pointed latch 14 on the tail cover 1 falls into the third latching step 37 of the main housing 3 to form a limit for the forward movement of the tail cap 1, and the barb and the two stoppers of the plug 5 of the triggering tube 5 are triggered.
  • the latch 81 of the outer sheath 8 cooperates with the bayonet 38 of the main casing 3 for locking the outer sheath 8 and the main casing 3;
  • the elastic latch 41 of the front sleeve 4 cooperates with the first latching step 31 of the main housing 3 for limiting the forward movement of the front sleeve 4 within the main housing 3;
  • the elastic latch 41 of the front sleeve 4 cooperates with the contact hook 11 of the tail cover 1 for limiting the rearward movement of the tail cover 1 relative to the front sleeve 4;
  • the inclined surface 12 of the tail cap 1 cooperates with the elastic latch 41 of the front sleeve 4 for releasing the restriction of the forward movement of the front sleeve 4 in the main casing 3. Specifically, in use, as the tail cap 1 moves forward, the inclined surface 12 presses the elastic latch 41 inwardly, eventually forcing the elastic latch 41 to be unhooked from the first latching step 31, releasing the front sleeve 4 in the main casing a limit for forward movement within the body 3;
  • the contact hook 11 of the tail cover 1 cooperates with the projection 42 of the front sleeve 4 for limiting the forward movement of the front sleeve 4.
  • the tail cap 1 moves forward, and the contact hook 11 is raised by the slant of the protrusion 42 and then passes over the protrusion 42 and is in the elastic cassette 41 and the After the hook step 31 is unhooked, the contact hook 11 hooks the protrusion 42 to limit the forward movement of the front sleeve 4 (the protrusion 42 is intercepted by the contact hook 11 in the forward movement);
  • the elastic latch 41 of the front sleeve 4 cooperates with the escaping groove 32 of the main casing 3 for avoiding interference of the elastic latch 41 with the spring 7.
  • the elastic latch 41 passes over the first latching step 31 of the main housing 3 and falls into the escaping slot 32 in order to avoid interference of the elastic latch 41 against the spring 7 (to prevent the elastic latch 41 from coming into contact)
  • the spring 7 forms an interference
  • the cap 15 of the tail cap 1 cooperates with the seat pan 23 of the hub 2 for moving positioning. Specifically, in use, as the tail cap 1 moves forward, the cap 15 gradually contacts the seat pan 23, and pushes the seat pan 23 to break off the first position, and continues to move forward until it falls into the second position and cannot be moved again. ;
  • the seat 23 of the needle hub 2, the engagement between the block 81 of the outer sheath 8 and the bayonet 38 of the main casing 3, is used to allow the removal of the sheath 8 and the insulin pen and the injection needle
  • the state of the injection is ready to be associated. Specifically, in use, when the seat pan 23 on the needle hub 2 falls into the card slot 34 on the main casing 3, firstly, it indicates that the injection needle has been officially mounted to the insulin pen head; secondly, outside the seat pan 23 The ribs lift the latches 81 on the outer sheath 8 to deform the outer sheath 8 , and finally the latches 81 on the outer sheath 8 are released from the bayonet 38 on the main casing 3, thereby achieving external protection.
  • the sleeve 8 is unlocked from the main casing 3, and the sheath 8 can be removed at this time; thirdly, since the front end of the trigger tube 5 abuts against the inner end surface of the outer sheath 8, when the needle holder 2 moves forward, the needle holder 2 The positioning between the upper convex portion 22 and the concave portion 51 on the trigger tube 5 is unlocked, indicating that the trigger tube 5 has entered a state that can be triggered;
  • the plug 52 of the trigger tube 5 cooperates with the stopper 13 of the tail cap 1 for releasing the limit of the forward movement of the front sleeve 4. Specifically, when the front end of the trigger tube 5 is in contact with the human skin, the trigger tube 5 moves backward. At this time, the plug 52 on the trigger tube 5 lifts the stopper 13 on the tail cover 1 to force the contact hook of the tail cover 1 11 is gradually separated from the protrusion 42 of the front sleeve 4 until the front sleeve 4 is moved forward by the action of the spring 7 after being completely separated, and protrudes from the front end of the main casing 3, and the front end surface of the front sleeve 4 is blocked by the human body. The skin, flush with the front end surface of the trigger tube 5, and move together until the needle has completely entered the human skin and begins to inject insulin.
  • the projection 42 of the front sleeve 4 cooperates with the second latching step 35 of the main casing 3 for achieving a limit of the front sleeve 4 projecting outward from the main casing 3 (preventing the front sleeve 4 Sliding out of the main casing 3);
  • the elastic tail 43 of the front sleeve 4 cooperates with the anti-retraction groove 36 of the main casing 3 for realizing the limit of the front sleeve 4 retreating inward from the main casing 3 (preventing the front casing 4 from the main Retracting in the housing 3);
  • the tail cap 1 sharp angle latch 14 cooperates with the third latching step 37 of the main casing 3 to prevent the tail cap 1 from moving forward under the external force in the main casing 3, preventing the needle from being used twice.
  • Example 2 Disposable safe insulin injection needle (with front end needle protection without rear end needle protection) As shown in Fig. 36, the injection needle is composed of a needle body 6, a needle holder 2, a main casing 3, and an external protection The sleeve 8, the front sleeve 4, the trigger tube 5 and the spring 7.
  • Example 2 After fully understanding the insulin injection needle of Example 1, Example 2 has only a front end needle protection structure and no rear end needle protection structure as compared to Example 1. Specifically, there are the following differences in structural design: First, Embodiment 2 cancels the tail cover 1 in Embodiment 1;
  • the two front legs 16 of the tail cover 1 of the embodiment 1 are transplanted to the needle holder 2 of the embodiment 1, as shown in FIG.
  • Embodiment 2 retains the stopper 13 and the contact hook 11 provided on the front leg 16.
  • the second embodiment eliminates the sharp-angled latches 14 provided on the front legs 16.
  • the third latching step 37 is provided correspondingly to the rear portion of the inner wall of the main casing 3.
  • the outer sheath 8 in the assembled state before use, the outer sheath 8 is fitted outside the main casing 3, and the block 81 on the outer sheath 8 is snapped into the bayonet 38 of the main casing 3 and extends into the main In the casing 3, the outer sheath 8 is lockedly connected with the main casing 3; the needle seat 2 and the needle body 6 are located in the main casing 3, and the seat pan 23 on the needle seat 2 is in the first positioning position in the main casing 3.
  • the groove 21 in the circumferential direction of the outer edge of the seat plate 23 cooperates with the rib 33 on the inner edge of the main casing 3 to form a concave-convex positioning structure, and the two front legs 16 extending forward on the seat plate 23 are extended toward
  • the front sleeve 4 is located in the main casing 3, and the elastic latch 41 on the front sleeve 4 is caught on the first latching step 31 on the main casing 3, and the front sleeve 4 is restrained from the main casing 3 moving forward;
  • the trigger tube 5 is located in the front end of the main housing 3 and extends outside the front end for protecting the injection section of the needle body 6.
  • the trigger tube 5 is provided with a limit for moving forward relative to the main housing 3.
  • the rear portion of the trigger tube 5 is fitted over the seat post 24 of the hub 2, The rear portion of the trigger tube 5 is located in the front sleeve 4, and the trigger tube 5 is in the third positioning position.
  • the front end of the trigger tube 5 approaches or abuts against the front inner end surface of the outer sheath 8, and the recess 51 on the trigger tube 5 is stuck.
  • Positioning is formed on the convex portion 22 of the seat post 24, at which time the seat pan 23 on the hub 2 is in a first positioning position with respect to the main housing 3; one end of the spring 7 abuts against the two front legs 16 of the hub 2 The other end of the stopper 13 abuts against the inner end surface 44 of the front sleeve 4.
  • Figs. 40 and 41 in use, when the user screwes the insulin pen head into the injection needle of the embodiment, the head of the insulin pen pushes the seat pan 23 forward, and the slope of the inner side of the front leg 16 12 Pressing the elastic latch 41 inwardly, finally forcing the elastic latch 41 to be unhooked from the first latching step 31 and falling into the escaping slot 32, releasing the limit of the forward movement of the front sleeve 4 in the main housing 3, at this time The front sleeve 4 is moved forward by the spring 7 until the projection 42 is intercepted by the contact hook 11 to stop moving and to limit the forward movement of the front sleeve 4; at the same time, the seat 23 is from the first The positioning position is moved forward to the second positioning position.
  • the outer edge of the seat plate 23 and the front and rear end faces are engaged with the card slots 34 on the inner edge of the main casing 3 to form a card locking position structure.
  • the second positioning position is locked, and it is neither able to move forward nor move backward.
  • the front end of the trigger tube 5 abuts against the front inner end surface of the outer sheath 8, when the needle holder 2 moves forward, between the convex portion 22 on the needle holder 2 and the concave portion 51 on the trigger tube 5
  • the third position is unlocked, at which point the trigger tube 5 forms a sliding connection with the seat post 24.
  • the outer edge of the seat plate 23 pushes up the block 81 on the outer sheath 8, and the block 81 and the bayonet 38 are released, causing the outer sheath 8 and the main casing 3 to be unlocked.
  • the outer sheath 8 is removed.
  • the trigger tube 5 is brought into contact with the human skin, the needle body 6 begins to penetrate into the human skin, and the trigger tube 5 is moved backward.
  • the plug 52 on the trigger tube 5 pushes up the stopper 13 on the front leg 16, forcing the front leg.
  • the contact hook 11 of the 16 is gradually separated from the projection 42 of the front sleeve 4 until the front sleeve 4 is moved forward by the spring 7 after being completely separated, and protrudes from the front end of the main casing 3, the front sleeve 4
  • the front end face is blocked by the human skin, flushes with the front end surface of the trigger tube 5 and moves together until the needle completely enters the human skin and begins to inject insulin.
  • the front sleeve 4 when the injection needle is withdrawn from the human skin after use, the front sleeve 4 is pushed out of the front end of the main casing 3 by the spring 7 until the projection 42 on the front sleeve 4 is received by the main casing
  • the second latching step 35 on the 3 intercepts and stops extending forward, at which time the front sleeve 4 is used to protect the injection section of the needle body 6; at the same time, the elastic tail fin 43 of the front sleeve 4 is extended and then snapped into the main casing 3
  • the retaining groove 36 forms a limit for the rear sleeve 4 to move backward, prevents the front sleeve 4 from retreating, and finally removes the injection needle from the insulin pen head.
  • the first positioning structure adopts a concave-convex positioning structure, and instead of the elastic positioning structure or the friction positioning structure, the same or similar technical effects can be obtained.
  • the first positioning structure should adopt a non-locking positioning structure because the outer edge of the front seat plate 23 and the inner edge of the main casing 3 are in the first positioning position, and the outer edge of the middle seat plate 23 and the main casing are used. Axial sliding is required between the inner edges of the body 3.
  • the elastic positioning structure is formed by a matching elastic pin and a recess, and one of the elastic bead and the recess is disposed at The other side of the seat pan 23 is provided on the outer edge of the main casing 3.
  • the friction positioning structure is formed by frictional engagement of the outer edge of the seat plate 23 with the inner edge of the main casing 3.
  • the card positioning structure adopted by the second positioning structure may be replaced by an elastic positioning structure, a friction positioning structure or an end surface abutting positioning structure, and the same or similar may be obtained.
  • the technical effect is understood by those skilled in the art.
  • the second positioning structure can adopt a non-locking positioning structure, or a locking structure.
  • the elastic positioning structure, the friction positioning structure or the end surface abutment positioning structure should belong to a non-locking positioning structure, and in the above embodiment, the outer edge of the seat plate 23 and the front and rear side end faces are disposed on the inner edge of the main casing 3.
  • the card locking position structure formed by the cooperation of the card slot 34 should belong to a locking structure.
  • the seat pan 23 can slide back and forth in the card slot 34, thereby converting into Non-locking nature of the positioning structure.
  • the end face abutment positioning structure is formed by the front end surface of the outer edge of the seat plate 23 abutting against the inner end surface of the inner edge of the main casing 3.
  • the bayonet 38 is axially located in the second positioning position of the main housing 3, and the position of the bayonet 38 may be in the second positioning position or the second positioning position.
  • the vicinity refers to a point at the front or a rear side with the second positioning position as a base point.
  • such a positional relationship is set in order to satisfy a specific relationship: when the seat pan 23 is moved from the first positioning position to the second positioning position, the outer edge of the seat plate 23 is raised from the outer sheath.
  • the block 81 on the 8 deforms the outer sheath 8 and finally causes the block 81 to be released from the bayonet 38, thereby unlocking the outer sheath 8 and the main casing 3, and finally whether or not the outer sheath 8 is allowed to be removed.
  • the insulin pen is associated with the state in which the injection needle is ready for injection.
  • the limit of the trigger tube 5 being provided with respect to the main housing 3 for forward movement is formed by the front end of the trigger tube 5 approaching or abutting against the front inner end surface of the outer sheath 8.
  • the stop 53 of the trigger tube 5 abuts against the front inner end surface 44 of the front sleeve 4.
  • the card table 46 is formed with a limit for the forward movement of the trigger tube 5 relative to the main housing 3.
  • the present invention mainly relates to the hub 2, the main casing 3 and The outer sheath 8 and the structure and connection relationship therebetween are not associated with the tail cap 1, the front sleeve 4, the trigger tube 5, and the spring 7.
  • the tail cap 1, the front sleeve 4, the trigger tube 5, and the spring 7 are optional structures for the present invention, allowing them to undergo some changes, such as a front sleeve for protecting the injection section of the needle 2 4 and the trigger tube 5 is replaced by a tube body; the tail cover 1 for protecting the connecting portion of the needle body 2 is omitted; the technical solution of the present invention is applied to the Chinese patent CN101563124A introduced in the background art; the technology of the present invention is applied The scheme is applied to US Patent US 2011/0288491 A1 and the like.

Abstract

一次性安全型胰岛素注射针头，包括针体(6)、针座(2)、主壳体(3)以及外护套(8)，外护套(8)套装在主壳体(3)外，在外护套(8)与主壳体(3)之间设置卡块(81)和卡口(38)配合的锁定结构；在针座(2)上设置座盘(23)，座盘(23)外缘与主壳体(3)内缘具有滑动定位的连接关系，在安装注射针头时利用胰岛素笔头部的轴向推力使座盘(23)从第一定位位置移动至第二定位位置，座盘(23)外缘顶起外护套(8)上的卡块(81)，使卡块(81)与卡口(38)脱扣，外护套(8)与主壳体(3)解锁，在此状态下允许摘除外护套，提高了使用的安全性和便利性。

Description

一次性安全型胰岛素注射针头 技术领域
本发明涉及医用胰岛素注射工具，特别涉及一种一次性使用的安全型胰岛素注射针头。这种注射针头与胰岛素笔配套使用可用于自我给药或他人给药，其中胰岛素笔可重复使用，而注射针头为一次性使用针头。
背景技术
糖尿病是一种以高血糖为特征的代谢性疾病，目前尚无根治的方法，但给患者注射胰岛素可以有效控制病情。
胰岛素的注射工具多种多样，其中本发明所述的胰岛素注射针头是一种与胰岛素笔配套使用的注射工具，其中胰岛素笔携带规定量的胰岛素液体药物，可重复使用，而注射针头为一种带有安全保护装置的一次性使用针头。
中国专利CN101563124A公开了一种名称为《带有远侧和近侧针保护器的针保护装置》的发明专利申请；美国专利US2011/0288491A1公开了一种名称为《安全针组件》的发明专利申请。这两个专利申请均涉及胰岛素注射针头，其基本结构均包括：
1.用于注射胰岛素的针体以及固定针体的针座；
2.用来与胰岛素笔连接的主壳体；
3.用于保护针体使用前后安全的套管；
4.用于移动套管的弹簧；
5.用于保护注射针头整体的外护套，该外护套在上述两件专利的附图中未体现，但在实际产品中可以看到，且通常情况下不可缺少。实际应用中，外护套套装在主壳体的外侧，使用中当注射针头安装到胰岛素笔之后，可以手动摘除外护套，然后刺入人体皮肤注射胰岛素。
上述现有注射针头存在的不足是：
1.外护套与主壳体之间套接，从外护套的保护功能来看存在安全隐患，即当使用者或者其他人不小心拔出外护套时，注射针头就存在被污染和刺伤他人的风险；
2.从产品设计和使用的角度看，很难掌握外护套套接主壳体松紧适度的效果，松了容易摘除，但存在脱落风险；紧了尽管能够确保套接的稳定性，但使用中不易摘除(手感不好)，给使用者带来不便。特别是在大批量生产前提下，外护套套接主壳体松紧的一致性更难保证；
3.从产品设计的安全性角度看，是否允许摘除外护套与胰岛素笔和注射针头是否准备好注射的状态无关联性。
为此，本发明从注射针头使用的安全性和便利性角度入手对上述现有技术进行改进，以克服现有技术存在的缺陷。
发明内容
鉴于以上现有技术指出的缺点，本发明提供一种一次性安全型胰岛素注射针头，其目的是要解决上述现有技术使用中存在的安全性和便利性问题。
为达到上述目的，本发明采用的技术方案是：一种一次性安全型胰岛素注射针头，包括：
针体，该针体具有一个向前端方向延伸的注射段、一个向后端方向延伸的连接段和一个位于注射段和连接段之间的固定段；
针座，该针座用于固定针体，所述针体的固定段固定在针座上，针体的注射段从针座前端伸出，针体的连接段从针座后端伸出；
主壳体，该主壳体为筒体结构，在装配状态下针座和针体位于主壳体内，主壳体的后端用于连接胰岛素笔；
外护套，该外护套为套筒结构，在使用前装配状态下外护套套装在主壳体外侧，用于保护所述注射针头整体；
其创新在于：
所述针座上设有一个座盘，该座盘的外缘与主壳体的内缘相配合，对应座盘外缘在主壳体内缘上沿轴向间隔设有第一定位位置和第二定位位置，在所述注射针头安装到所述胰岛素笔的过程中，利用胰岛素笔头部对针座产生的轴向推力迫使座盘在主壳体内从第一定位位置沿轴向向前移动至第二定位位置，从而使针座与主壳体之间形成滑动定位的连接关系；在第一定位位置上座盘的外缘与主壳体的内缘通过第一定位结构进行配合，在第二定位位置上座盘的外缘与主壳体的内缘通过第二定位结构进行配合；所述第一定位结构采用凹凸定位结构、弹性定位结构或者摩擦定位结构；所述第二定位结构采用凹凸定位结构、弹性定位结构、摩擦定位结构、卡锁定位结构或者端面抵靠定位结构；
所述主壳体筒体侧壁上设有卡口，卡口在主壳体轴向上对应第二定位位置布置，该卡口为一个贯穿主壳体内外壁之间的通孔，对应该通孔在外护套套筒内壁上设有卡块，在外护套套装主壳体状态下卡块卡入卡口并伸入主壳体内，使外护套与主壳体锁定连接；当座盘从第一定位位置移动至第二定位位置时，座盘外缘顶起外护套上的卡块，使外护套发生变形，最终导致卡块与卡口脱扣，从而实现外护套与主壳体解锁，在此状态下允许摘除外护套。
上述技术方案中的有关内容解释如下：
1.在本发明中，所述“前端”、“向前”、“前后”、“前部”、“前方”、“前端面”中的“前”是指以本发明一次性安全型胰岛素注射针头注射段针尖所指的方向。所述“后端”、“前后”、 “向后”、“后部”、“后方”中的“后”是指“前”的反方向。
2.上述方案中，为了有利于外护套与主壳体脱扣解锁，可以在外护套的套筒内壁上沿轴向设有向内突出的筋条，当外护套套装在主壳体外侧后，外护套内壁与主壳体外壁之间留有供外护套发生变形的间隙。
3.上述方案中，为了方便外护套上的卡块脱离主壳体上的卡口，可以在主壳体的卡口处设有向前端方向延伸的滑槽。
4.上述方案中，所述凹凸定位结构由设在座盘外缘圆周方向的凹沟与设在主壳体内缘上的凸筋配合形成。
5.上述方案中，所述弹性定位结构由弹性珠销与凹陷配合形成，弹性珠销和凹陷两者中，一者设在座盘外缘上，另一者设在主壳体内缘上。
6.上述方案中，所述摩擦定位结构由座盘外缘与主壳体内缘摩擦配合形成。
7.上述方案中，所述卡锁定位结构由座盘外缘及前后侧端面与主壳体内缘上所设的卡槽配合形成。
8.上述方案中，所述端面抵靠定位结构由座盘外缘的前侧端面与主壳体内缘的内端面抵靠配合形成。
9.上述方案中，“卡口在主壳体轴向上对应第二定位位置布置”中的“对应”两字的含意包含三种情况：第一是卡口在主壳体轴向位于第二定位位置上；第二是卡口在主壳体轴向位于第二定位位置的附近且靠前方；第三是卡口在主壳体轴向位于第二定位位置的附近且靠后方。
本发明设计原理和效果是：本发明涉及一种需要与胰岛素笔配套使用的一次性安全型胰岛素注射针头。为了解决上述现有技术中指出的安全性和便利性问题，本发明的技术构思是：
第一，在外护套与主壳体原有套接的基础上增加了锁定结构，解决外护套套接保护注射针头可靠性问题，保证外护套在注射针头正式使用前不会被摘除，提高安全性；
第二，将用来固定针体的针座与主壳体之间设计成滑动定位的连接关系，即在安装注射针头时利用胰岛素笔头部对针座的轴向推力迫使针座上的座盘从第一定位位置向前移动至第二定位位置后停止，从而将注射针头是否安装到位的信息与针座上的座盘在主壳体内的移动位置关联起来；
第三，将注射针头是否安装到位的信息通过座盘在主壳体内的移动位置与外护套是否解锁关联起来，最终将是否允许摘除外护套与胰岛素笔和注射针头是否准备好注射的状态关联起来，从而大大提高了注射针头使用的安全性和便利性。
总之，本发明从产品设计的角度充分发挥了外护套在安全保护方面的作用和效能， 并且合理利用了安装注射针头的轴向推力及位置使外护套达到自动解锁的目的。其技术构思巧妙，设计方案合理，具有突出的实质性特点和显著的技术进步，充分体现了注射针头使用的安全性和便利性。
附图说明
附图1为本发明实施例一次性安全型胰岛素注射针头的立体图；
附图2为本发明实施例一次性安全型胰岛素注射针头的立体分解图；
附图3为本发明实施例尾盖的立体图；
附图4为本发明实施例针座和针体的立体图；
附图5为本发明实施例主壳体带局部剖的立体图；
附图6为本发明实施例前套管的立体图；
附图7为本发明实施例前套管带局部剖的立体图；
附图8为本发明实施例触发管的立体图；
附图9为本发明实施例触发管带局部剖的立体图；
附图10为本发明实施例外护套带局部剖的立体图；
附图11为本发明实施例带A-A剖视标记的一次性安全型胰岛素注射针头的端面视图；
附图12为本发明实施例带B-B剖视标记的一次性安全型胰岛素注射针头的端面视图；
附图13为本发明实施例带C-C剖视标记的一次性安全型胰岛素注射针头的端面视图；
附图14为本发明实施例使用前状态下的A-A剖视图；
附图15为本发明实施例使用前状态下的C-C剖视图；
附图16为本发明实施例使用前状态下隐去尾盖后的A-A剖视图；
附图17为本发明实施例使用第一阶段将胰岛素笔旋入注射针头时的A-A剖视图；
附图18为本发明实施例使用第二阶段胰岛素笔继续旋入注射针头时的A-A剖视图；
附图19为本发明实施例使用第三阶段胰岛素笔继续旋入注射针头时的A-A剖视图；
附图20为本发明实施例使用第三阶段胰岛素笔继续旋入注射针头时的B-B剖视图；
附图21为本发明实施例使用第四阶段胰岛素笔继续旋入注射针头时的C-C剖视图；
附图22为本发明实施例使用第四阶段胰岛素笔继续旋入注射针头时的A-A剖视图；
附图23为本发明实施例使用第四阶段胰岛素笔继续旋入注射针头时的B-B剖视图；
附图24为本发明实施例使用第五阶段摘除外护套时的立体图；
附图25为本发明实施例使用第五阶段摘除外护套时的A-A剖视图；
附图26为本发明实施例使用第六阶段针体开始刺入人体皮肤时的A-A剖视图；
附图27为本发明实施例使用第七阶段针体刺入人体皮肤时的A-A剖视图；
附图28为本发明实施例使用第八阶段针体完全刺入人体皮肤并注射胰岛素时的A-A剖视 图；
附图29为本发明实施例使用第九阶段注射完胰岛素针体从皮肤中拔出后时的A-A剖视图；
附图30为本发明实施例使用第九阶段注射完胰岛素针体从皮肤中拔出后时的B-B剖视图；
附图31为本发明实施例使用第十阶段胰岛素笔旋出注射针头时的A-A剖视图；
附图32为本发明实施例使用后状态下的A-A剖视图；
附图33为本发明前套管为显示“卡台”的立体图；
附图34为本发明触发管为显示“挡台”的立体图；
附图35为显示“卡台”与“挡台”配合的B-B剖视图；
附图36为本发明另一实施例胰岛素注射针头的立体图；
附图37为本发明另一实施例中针座的立体图；
附图38为本发明另一实施例使用前状态下的A-A剖视图；
附图39为本发明另一实施例使用前状态下的B-B剖视图；
附图40为本发明另一实施例使用中摘除外护套时的A-A剖视图；
附图41为本发明另一实施例使用中摘除外护套时的B-B剖视图；
附图42为本发明另一实施例使用后状态下的A-A剖视图；
附图43为本发明另一实施例使用后状态下的B-B剖视图。
以上附图中：
1.尾盖；11.触脚钩；12.斜面；13.挡块；14.尖角卡榫；15.盖帽；16.前腿；17.让位孔；
2.针座；21.凹沟；22.凸部；23.座盘；24.座杆；25.让位槽；
3.主壳体；31.第一卡榫台阶；32.规避槽；33.凸筋；34.卡槽；35.第二卡榫台阶；36.防退槽；37.第三卡榫台阶；38.卡口；39.滑槽；
4.前套管；41.弹性卡榫；42.凸起；43.弹性尾翼；44.内端面；45.倾斜面；46.卡台；
5.触发管；51.凹部；52.插头；53.挡台；
6.针体；
7.弹簧；
8.外护套；81.卡块；82.筋条。
具体实施方式
下面结合附图及实施例对本发明作进一步描述：
实施例1：一次性安全型胰岛素注射针头(带前端针尖保护和后端针尖保护)
如图1-10所示，该注射针头由针体6、针座2、主壳体3、外护套8、尾盖1、前套管4、触 发管5以及弹簧7(见图2)。
下面依次描述本实施例一次性安全型胰岛素注射针头的各零部件结构：
1.针体6
所述针体6是一个用于注射胰岛素管针，该针体6具有一个向前端方向延伸的注射段、一个向后端方向延伸的连接段和一个位于注射段和连接段之间的固定段。
2.针座2
所述针座2用于固定针体6(见图4)，针体6的固定段固定在针座2上，针体6的注射段从针座2前端伸出，针体6的连接段从针座2后端伸出。针座2由座盘23和座杆24组成，座杆24位于座盘23前端并与座盘23固定连接，座杆24上设有凸部22，座盘23上设有两个让位槽25，座盘23外缘圆周方向设有凹沟21。
3.主壳体3
所述主壳体3是用来容纳除外护套8而外其他零部件壳体(见图5)。主壳体3为筒体结构，在装配状态下针座2和针体6等零部件位于主壳体3内。主壳体3筒体内壁中部设有第一卡榫台阶31，主壳体3筒体内壁前端设有第二卡榫台阶35，主壳体3筒体内壁后部设有第三卡榫台阶37，主壳体3筒体内壁前部设有防退槽36，主壳体3筒体内壁前部还设有规避槽32，主壳体3内缘上设有凸筋33和卡槽34，凸筋33位于主壳体3轴向的第一定位位置，卡槽34位于主壳体3轴向的第二定位位置，如果以主壳体3后端为基准，第一定位位置至主壳体3后端的距离小于第二定位位置至主壳体3后端的距离。主壳体3筒体侧壁上设有卡口38，卡口38在主壳体3轴向位于第二定位位置上，该卡口38为一个贯穿主壳体3内外壁之间的通孔，卡口38处设有向前端方向延伸的滑槽39(以有利于卡块81与卡口38脱离)。主壳体3的后端用于连接胰岛素笔，其连接结构可以采用螺纹连接方式，也可以采用插拔连接方式，还可以采用插拔旋转扣接方式等等。在本实施例中，图5主壳体3显示的是螺纹连接方式。
4.外护套8
所述外护套8用于保护所述注射针头整体(见图10)。该外护套8为套筒结构，在使用前装配状态下外护套8套装在主壳体3外侧。外护套8套筒内壁上设有卡块81，卡块81在位置上对应主壳体3筒体侧壁上的卡口38，在外护套8套装主壳体3状态下卡块81卡入卡口38并伸入主壳体3内，使外护套8与主壳体3锁定连接。外护套8的套筒内壁上沿轴向设有向内突出的筋条82，当外护套8套装在主壳体3外侧后，外护套8内壁与主壳体3外壁之间留有供外护套8发生变形的间隙。
5.尾盖1
所述尾盖1用于保护针体6的连接段(见图3)。尾盖1由一个盖帽15和两个前腿16组成， 盖帽15为端盖或环状体，盖帽15的中央设有仅供针体6连接段穿插的让针孔17，让针孔17轴线与主壳体3轴线平行，两个前腿16固定连接在盖帽15前端上，并且以让针孔17轴线为基准对称布置，每个前腿16的内侧在根部位置上设有斜面12，在中部位置上设有向内延伸的挡块13，在末端位置上设有触脚钩11；每个前腿16的外侧在中部位置上设有尖角卡榫14。
6.前套管4
所述前套管4用于保护使用后针体6的注射段(见图6和图7)。前套管4的主体结构为管体，前套管4的前端内侧设有内端面44；前套管4的后端设有向后延伸的弹性卡榫41和向后延伸的弹性尾翼43，弹性卡榫41与弹性尾翼43在前套管4周向错开布置；前套管4的中部外侧设有向外延伸的凸起42，凸起42和弹性卡榫41在前套管4周向位置对应，凸起42靠弹性卡榫41一侧设有倾斜面45。
7.触发管5
所述触发管5用于保护使用前针体6的注射段(见图8和图9)。触发管5的主体结构为管体，触发管5的后端设有向后延伸的两个插头52，插头52上设有倒钩，触发管5管体内设有凹部51。
8.弹簧7
所述弹簧7用于推压前套管4和尾盖1。
下面描述为解决本发明技术问题所需要的结构、连接关系和位置关系：
1.结构特征
在外护套8与主壳体3原有套接的基础上增加了锁定结构。即在主壳体3筒体侧壁上设有卡口38，对应该卡口38位置在外护套8套筒内壁上设有卡块81，在外护套8套装主壳体3状态下卡块81卡入卡口38并伸入主壳体3内，使外护套8与主壳体3锁定连接。
总之，该结构特征解决了外护套8套接保护注射针头的可靠性和安全性问题，保证外护套8在注射针头正式使用前不会被摘除。
2.连接关系特征
将用来固定针体6的针座2与主壳体3之间设计成滑动定位的连接关系。即针座2上座盘23的外缘与主壳体3的内缘相配合，对应座盘23外缘在主壳体3内缘上沿轴向间隔设有第一定位位置和第二定位位置，在所述注射针头安装到所述胰岛素笔的过程中，利用胰岛素笔头部对针座2产生的轴向推力迫使座盘23在主壳体3内从第一定位位置沿轴向向前移动至第二定位位置，从而使针座2与主壳体3之间形成滑动定位的连接关系。
在第一定位位置上座盘23的外缘与主壳体3的内缘通过第一定位结构进行配合，在第二定位位置上座盘23的外缘与主壳体3的内缘通过第二定位结构进行配合。所述第一定 位结构为凹凸定位结构，该凹凸定位结构具体由设在座盘23外缘圆周方向的凹沟21与设在主壳体3内缘上的凸筋33配合形成。所述第二定位结构为卡锁定位结构，该卡锁定位结构具体由座盘23外缘及前后侧端面与主壳体3内缘上所设的卡槽34配合形成。
总之，该连接关系特征目的是要在安装注射针头时利用胰岛素笔头部对针座2的轴向推力迫使针座2上的座盘23从第一定位位置向前移动至第二定位位置后停止，从而将注射针头是否安装到位的信息与针座2上的座盘23在主壳体3内的移动位置关联起来。
3.位置关系特征
将主壳体3上的卡口38位置设在主壳体3轴向第二定位位置上。当座盘23从第一定位位置移动至第二定位位置时，座盘23外缘顶起外护套8上的卡块81，使外护套8发生变形，最终导致卡块81与卡口38脱扣，从而实现外护套8与主壳体3解锁，在此状态下允许摘除外护套8。
总之，该位置关系特征将注射针头是否安装到位的信息通过座盘23在主壳体3内的移动位置与外护套8是否解锁关联起来，最终将是否允许摘除外护套8与胰岛素笔和注射针头是否准备好注射的状态关联起来，从而大大提高了注射针头使用的安全性和便利性。
本实施例一次性安全型胰岛素注射针头在使用前装配状态下各零部件的连接关系及位置关系描述如下：
如图14-16所示，在使用前装配状态下，外护套8套装在主壳体3外侧，外护套8上的卡块81卡入主壳体3的卡口38并伸入主壳体3内，使外护套8与主壳体3锁定连接；针座2和针体6位于主壳体3内，针座2上的座盘23处于主壳体3内第一定位位置，在第一定位位置上座盘23外缘圆周方向的凹沟21与主壳体3内缘上的凸筋33配合形成凹凸定位结构(见图15)；尾盖1位于主壳体3后端内，尾盖1上的盖帽15位于座盘23后方用于保护针体6的连接段(见图14和图15)，尾盖1上的两个前腿16穿过座盘23上的两个让位槽25伸向前方(见图14和图15)；所述前套管4位于主壳体3内，前套管4上的弹性卡榫41卡在主壳体3上的第一卡榫台阶31上，限制前套管4相对主壳体3向前运动(见图16)，同时尾盖1两个前腿16上的触脚钩11勾在前套管4的弹性卡榫41上(见图14)；所述触发管5位于主壳体3前端内并延伸至前端外，用于保护针体6的注射段(见图14)，触发管5的后部套装在针座2的座杆24上，触发管5的后部位于前套管4内，触发管5的前端接近或顶靠在外护套8的前部内端面上，触发管5上的凹部51卡在座杆24的凸部22上形成定位(见图15和图16)；所述弹簧7一端抵靠在尾盖1两个前腿16的挡块13上，另一端抵靠在前套管4的内端面44上(见图14)。
本实施例一次性安全型胰岛素注射针头的使用过程描述如下：
第一阶段：
图17表示第一阶段的状态。从图17中可以看出，在此状态下，使用者将胰岛素笔头部旋入本实施例所述注射针头。胰岛素笔的头部推动尾盖1向前移动，图17中的箭头表示胰岛素笔头部产生的推力，同时尾盖1的触脚钩11被前套管4凸起42上的倾斜面45顶起。
第二阶段：
图18表示第二阶段的状态。从图18中可以看出，在此状态下，胰岛素笔继续旋入注射针头，尾盖1的触脚钩11越过前套管4凸起42，同时尾盖1的斜面12压迫前套管4上的弹性卡榫41向内弯曲。
第三阶段：
图19和图20表示第三阶段的状态。在此状态下，胰岛素笔继续旋入注射针头，弹性卡榫41继续向内弯曲，最终迫使弹性卡榫41与第一卡榫台阶31脱钩并落入规避槽32，解除了前套管4在主壳体3内向前运动的限位，此时在弹簧7的推动下前套管4向前移动，直到凸起42被触脚钩11拦截而停止移动并对前套管4向前运动进行限位(见图19)。从图20中可以看出，在此状态下，外护套8上的卡块81卡入主壳体3的卡口38并伸入主壳体3内，针座2上的座盘23仍处于第一定位位置，而尾盖1渐渐接触针座2上的座盘23。
第四阶段：
图21、图22和图23表示第四阶段的状态。在此状态下，胰岛素笔继续旋入注射针头，尾盖1上的盖帽15抵靠针座2的座盘23并推动座盘23从第一定位位置向前移动至第二定位位置(见图21)，在第二定位位置上座盘23外缘及前后侧端面卡入主壳体3内缘上的卡槽34中配合形成卡锁定位结构，座盘23在第二定位位置上被锁定，既不能向前继续移动，也不能向后移动。在此状态下，由于触发管5前端顶靠在外护套8的前部内端面上，当针座2向前移动时，针座2上的凸部22与触发管5上的凹部51之间的定位被解锁(见图22)。在此状态下，座盘23外缘顶起外护套8上的卡块81，使卡块81与卡口38脱扣，导致外护套8与主壳体3解锁，在此状态下允许摘除外护套8(见图23)。
第五阶段：
图25和图26表示第五阶段的状态。在此状态下，用手摘除外护套8。
第六阶段：
图26表示第六阶段的状态。在此状态下，将触发管5与人体皮肤接触，针体6开始刺入人体皮肤。当触发管5的前端与人体皮肤接触时，触发管5向后移动，此时触发管5上的插头52顶起尾盖1上的挡块13，迫使尾盖1的触脚钩11与前套管4的凸起42渐渐分离。
第七阶段：
图27表示第七阶段的状态。在此状态下，触发管5继续向后移动，直到触脚钩11与凸起42完全分离后在弹簧7的推动下前套管4向前移动，并伸出主壳体3前端，前套管4的前 端面受阻于人体皮肤，与触发管5前端面平齐并一起运动。
第八阶段：
图28表示第八阶段的状态。在此状态下，针体6完全进入人体皮肤后开始注射胰岛素。
第九阶段：
图29和图30表示第九阶段的状态。在此状态下，从人体皮肤拔出所述注射针头，此时前套管4被弹簧7推出主壳体3前端，直到前套管4上的凸起42被主壳体3上的第二卡榫台阶35拦截而停止向前伸出，此时前套管4用来保护针体6的注射段(见图29)。在此状态下，前套管4的弹性尾翼43伸展后卡入主壳体3的防退槽36中形成前套管4向后移动的限位，防止前套管4回退(见图30)。
第十阶段：
图31表示第十阶段的状态。在此状态下，将胰岛素笔旋出注射针头，尾盖1在弹簧7推动下向后移动，同时尾盖1上的两个挡块13夹持住触发管5上的插头52，并带动触发管5向后移动。
使用后状态：
图32表示使用后状态。在此状态下，随着胰岛素笔不断旋出，触发管5继续向后移动直到针座2上的座杆24前端低靠触发管5前部内端面而停止。接着，尾盖1上的尖角卡榫14落入主壳体3的第三卡榫台阶37形成尾盖1向前移动的限位，而触发管5插头52的倒钩与两个挡块13配合，用来限制尾盖1在主壳体3后端内向后移动，此时尾盖1用来保护针体6的连接段，同时防止所述注射针头被二次使用。
从以上实施例中可以看出，本发明一次性安全型胰岛素注射针头中各个零部件结构之间的配合与其实现功能的关系如下：
1.在使用前状态下，有下列关系：
(1)外护套8的卡块81与主壳体3的卡口38配合，用于实现外护套8与主壳体3的锁定；
(2)针座2的凹沟21与主壳体3的凸筋33配合，用于实现针座2与主壳体3的定位(第一定位)；
(3)针座2的凸部22与触发管5的凹部51配合，用于实现触发管5与针座2的定位；
(4)前套管4的弹性卡榫41与主壳体3的第一卡榫台阶31配合，用于实现前套管4在主壳体3内向前运动的限位；
(5)前套管4的弹性卡榫41与尾盖1的触脚钩11配合，用于实现尾盖1相对前套管4向后运动的限位；
(6)弹簧7、尾盖1的挡块13与前套管4的内端面44之间的配合，其中，弹簧7一端抵靠在尾盖1的挡块13上，另一端抵靠在前套管4的内端面44，用于实现尾盖1、前套管4 和弹簧7之间的连接和定位。
2.在使用中状态下，有下列关系：
(1)尾盖1的斜面12与前套管4的弹性卡榫41配合，用于解除前套管4在主壳体3内向前运动的限位。具体是：在使用中，随着尾盖1向前移动，斜面12压迫弹性卡榫41向内弯曲，最终迫使弹性卡榫41与第一卡榫台阶31脱钩，解除前套管4在主壳体3内向前运动的限位；
(2)尾盖1的触脚钩11与前套管4的凸起42配合，用于实现对前套管4向前运动进行限位。具体是：在使用中，随着胰岛素笔不断旋入注射针头，尾盖1向前移动，触脚钩11被凸起42斜面顶起，之后越过凸起42，并在弹性卡榫41与第一卡榫台阶31脱钩后，触脚钩11勾住凸起42对前套管4向前运动进行限位(凸起42在向前运动中被触脚钩11拦截)；
(3)针座2的座盘23与主壳体3的卡槽34配合，用于实现针座2与主壳体3的定位(第二定位)；
(4)前套管4的弹性卡榫41与主壳体3的规避槽32配合，用于避免弹性卡榫41对弹簧7的干涉。具体是：在使用中，弹性卡榫41越过主壳体3的第一卡榫台阶31后落入规避槽32中是为了避免弹性卡榫41对弹簧7的干涉(避免弹性卡榫41碰到弹簧7形成干涉)；
(5)尾盖1的盖帽15与针座2的座盘23配合，用于实现移动定位。具体是：在使用中，随着尾盖1向前移动，盖帽15渐渐接触座盘23，并推动座盘23挣脱上述第一定位，继续向前移动，直到落入第二定位后不能再动；
(6)针座2的座盘23、外护套8的卡块81与主壳体3的卡口38之间的配合，用来将是否允许摘除外护套8与胰岛素笔和注射针头是否准备好注射的状态关联起来。具体是：在使用中，当针座2上的座盘23落入主壳体3上的卡槽34时，首先，表明注射针头已正式安装到胰岛素笔头部；其次，座盘23的外缘顶起外护套8上的卡块81，使外护套8在发生变形，最终导致外护套8上的卡块81与主壳体3上的卡口38脱扣，从而实现外护套8与主壳体3的解锁，此时可以摘除外护套8；第三，由于触发管5前端抵靠在外护套8的内端面上，当针座2向前移动时，针座2上的凸部22与触发管5上的凹部51之间的定位被解锁，表明触发管5已进入可以触发的状态；
(7)触发管5的插头52与尾盖1的挡块13配合，用于解除前套管4向前移动的限位。具体是：当触发管5的前端与人体皮肤接触时，触发管5向后移动，此时触发管5上的插头52顶起尾盖1上的挡块13，迫使尾盖1的触脚钩11与前套管4的凸起42渐渐分离，直到完全分离后在弹簧7的作用下前套管4向前移动，并伸出主壳体3前端，前套管4的前端面受阻于人体皮肤，与触发管5前端面平齐并一起运动，直到针完全进入人体皮肤后开始注射胰岛素。
3.在使用后状态下，有下列关系：
(1)前套管4的凸起42与主壳体3的第二卡榫台阶35配合，用于实现前套管4从主壳体3向外伸出的限位(防止前套管4从主壳体3中滑出)；
(2)前套管4的弹性尾翼43与主壳体3的防退槽36配合，用于实现前套管4从主壳体3向内回退的限位(防止前套管4从主壳体3中回退)；
(3)尾盖1尖角卡榫14与主壳体3的第三卡榫台阶37配合，用来阻止尾盖1在主壳体3内在外力作用下向前移动，防止针头二次使用。
实施例2：一次性安全型胰岛素注射针头(带前端针尖保护，而不带后端针尖保护)如图36所示，该注射针头由针体6、针座2、主壳体3、外护套8、前套管4、触发管5以及弹簧7。
在完全理解了实施例1胰岛素注射针头之后，实施例2与实施例1相比仅带有带前端针尖保护结构，不带有后端针尖保护结构。具体来说，在结构设计方面存在如下不同：第一，实施例2取消了实施例1中的尾盖1；
第二，实施例2将实施例1尾盖1中的两个前腿16移植到实施例1针座2上，见图37所示。实施例2保留了前腿16上所设的挡块13和触脚钩11。实施例2取消了前腿16上所设的尖角卡榫14。
第三，实施例2由于取消了前腿16上所设的尖角卡榫14，所以对应取消了主壳体3筒体内壁后部设有第三卡榫台阶37。
第四，实施例2与实施例1相比由于在使用前装配状态下前腿16的位置发生了变化(比原来位置靠前向，已越过前套管4的凸起42)，所以对应取消了凸起42一侧的倾斜面45。
实施例2所述胰岛素注射针头的其余结构与实施例1完全相同，为了节省篇幅这理不再进行重复描述，本领域技术人员完全理解实施例1之后应容易理解实施例2。
实施例2胰岛素注射针头的使用过程简述如下：
如图38和39所示，在使用前装配状态下，外护套8套装在主壳体3外侧，外护套8上的卡块81卡入主壳体3的卡口38并伸入主壳体3内，使外护套8与主壳体3锁定连接；针座2和针体6位于主壳体3内，针座2上的座盘23处于主壳体3内第一定位位置，在第一定位位置上座盘23外缘圆周方向的凹沟21与主壳体3内缘上的凸筋33配合形成凹凸定位结构，座盘23上向前延伸的两个前腿16伸向前方；所述前套管4位于主壳体3内，前套管4上的弹性卡榫41卡在主壳体3上的第一卡榫台阶31上，限制前套管4相对主壳体3向前运动；所述触发管5位于主壳体3前端内并延伸至前端外，用于保护针体6的注射段，触发管5相对主壳体3设有向前移动的限位，触发管5的后部套装在针座2的座杆24上， 触发管5的后部位于前套管4内，触发管5处于第三定位位置上，触发管5的前端接近或顶靠在外护套8的前部内端面上，触发管5上的凹部51卡在座杆24的凸部22上形成定位，此时，针座2上的座盘23相对主壳体3处于第一定位位置上；所述弹簧7一端抵靠在针座2两个前腿16的挡块13上，另一端抵靠在前套管4的内端面44上。
如图40和41所示，在使用中，当使用者将胰岛素笔头部旋入本实施例所述注射针头时，胰岛素笔的头部推动座盘23向前移动，前腿16内侧的斜面12压迫弹性卡榫41向内弯曲，最终迫使弹性卡榫41与第一卡榫台阶31脱钩并落入规避槽32，解除前套管4在主壳体3内向前运动的限位，此时在弹簧7的推动下前套管4向前移动，直到凸起42被触脚钩11拦截而停止移动并对前套管4向前运动进行限位；与此同时，座盘23从第一定位位置向前移动至第二定位位置，在第二定位位置上座盘23外缘及前后侧端面卡入主壳体3内缘上的卡槽34中配合形成卡锁定位结构，座盘23在第二定位位置上被锁定，既不能向前继续移动，也不能向后移动。在此状态下，由于触发管5前端顶靠在外护套8的前部内端面上，当针座2向前移动时，针座2上的凸部22与触发管5上的凹部51之间的第三定位被解锁，此时触发管5与座杆24形成滑动连接。同时，在此状态下，座盘23外缘顶起外护套8上的卡块81，使卡块81与卡口38脱扣，导致外护套8与主壳体3解锁，在此状态下摘除外护套8。接着，将触发管5与人体皮肤接触，针体6开始刺入人体皮肤，触发管5向后移动，此时触发管5上的插头52顶起前腿16上的挡块13，迫使前腿16的触脚钩11与前套管4的凸起42渐渐分离，直到完全分离后在弹簧7的推动下前套管4向前移动，并伸出主壳体3前端，前套管4的前端面受阻于人体皮肤，与触发管5前端面平齐并一起运动，直到针完全进入人体皮肤后开始注射胰岛素。
如图42和43所示，在使用后从人体皮肤拔出所述注射针头时，前套管4被弹簧7推出主壳体3前端，直到前套管4上的凸起42被主壳体3上的第二卡榫台阶35拦截而停止向前伸出，此时前套管4用来保护针体6的注射段；同时前套管4的弹性尾翼43伸展后卡入主壳体3的防退槽36中形成前套管4向后移动的限位，防止前套管4回退，最后从所述胰岛素笔头部拆除所述注射针头。
以上实施例中的有关内容和变化说明如下：
1.以上两个实施例中，所述第一定位结构采用的是凹凸定位结构，除此而外可以采用弹性定位结构或者摩擦定位结构来替换，也可获得相同或相似的技术效果，这是本领域技术人员可理解的。从理论上讲第一定位结构应采用非锁死性质的定位结构，因为在使用前座盘23外缘与主壳体3内缘处于第一定位位置，而使用中座盘23外缘与主壳体3内缘之间需要轴向滑动。
所述弹性定位结构由弹性珠销与凹陷配合形成，弹性珠销和凹陷两者中，一者设在 座盘23外缘上，另一者设在主壳体3内缘上。
所述摩擦定位结构由座盘23外缘与主壳体3内缘摩擦配合形成。
2.以上两个实施例中，所述第二定位结构采用的卡锁定位结构，除此而外可以采用弹性定位结构、摩擦定位结构或者端面抵靠定位结构来替换，也可获得相同或相似的技术效果，这是本领域技术人员可理解的。从理论上讲第二定位结构可以采用非锁死性质的定位结构，也可以采用锁死性质的定位结构。弹性定位结构、摩擦定位结构或者端面抵靠定位结构应属于非锁死性质的定位结构，而以上实施例中，由座盘23外缘及前后侧端面与主壳体3内缘上所设的卡槽34配合形成的卡锁定位结构应属于锁死性质的定位结构。但是在这种卡锁定位结构中，当卡槽34的宽度大于座盘23厚度时就存在间隙，当这种间隙大到一定程度座盘23便可以在卡槽34中来回滑动，从而转化成非锁死性质的定位结构。
所述端面抵靠定位结构由座盘23外缘的前侧端面与主壳体3内缘的内端面抵靠配合形成。
3.以上两个实施例中，所述卡口38在主壳体3轴向位于第二定位位置上，实际上卡口38的位置只要在第二定位位置上或者第二定位位置附近均可以获得相同或相似的技术效果。所述附近是指以第二定位位置为基点靠前方一点或靠后方一点。在本发明中这样的位置关系是为了满足特定关系而设定的，这种特定关系是：当座盘23从第一定位位置移动至第二定位位置时，座盘23外缘顶起外护套8上的卡块81，使外护套8发生变形，最终导致卡块81与卡口38脱扣，从而实现外护套8与主壳体3解锁，最终将是否允许摘除外护套8与胰岛素笔和注射针头是否准备好注射的状态关联起来。
4.以上实施例中，所述触发管5相对主壳体3设有向前移动的限位由触发管5的前端接近或顶靠在外护套8的前部内端面上形成。为了实现对触发管5向前移动的限位还可以采用其他结构形式，比如参见附图33-图35所示，触发管5的挡台53顶靠在前套管4的前部内端面44上的卡台46上形成触发管5相对主壳体3设有向前移动的限位。
5.以上两个实施例是为了说明本发明技术方案而给出的一个实例，从本发明背景技术介绍以及需要解决的技术问题和发明目的来看，主要涉及针座2、主壳体3和外护套8及其他们之间的结构和连接关系，与尾盖1、前套管4、触发管5以及弹簧7关联不大。换句话说，尾盖1、前套管4、触发管5以及弹簧7对于本发明来说属于非必要结构，可以允许他们发生一些变化，比如，用于保护针体2注射段的前套管4和触发管5使用一根管体来代替；省去用于保护针体2连接段的尾盖1；将本发明的技术方案应用于背景技术介绍的中国专利CN101563124A中；将本发明的技术方案应用于美国专利US2011/0288491A1中等等。
上述实施例只为说明本发明的技术构思及特点，其目的在于让熟悉此项技术的人士能够了解本发明的内容并据以实施，并不能以此限制本发明的保护范围。凡根据本发明精 神实质所作的等效变化或修饰，都应涵盖在本发明的保护范围之内。

Claims (9)

  1. 一种一次性安全型胰岛素注射针头，包括：
    针体(6)，该针体(6)具有一个向前端方向延伸的注射段、一个向后端方向延伸的连接段和一个位于注射段和连接段之间的固定段；
    针座(2)，该针座(2)用于固定针体(6)，所述针体(6)的固定段固定在针座(2)上，针体(6)的注射段从针座(2)前端伸出，针体(6)的连接段从针座(2)后端伸出；
    主壳体(3)，该主壳体(3)为筒体结构，在装配状态下针座(2)和针体(6)位于主壳体(3)内，主壳体(3)的后端用于连接胰岛素笔；
    外护套(8)，该外护套(8)为套筒结构，在使用前装配状态下外护套(8)套装在主壳体(3)外侧，用于保护所述注射针头整体；
    其特征在于：
    所述针座(2)上设有一个座盘(23)，该座盘(23)的外缘与主壳体(3)的内缘相配合，对应座盘(23)外缘在主壳体(3)内缘上沿轴向间隔设有第一定位位置和第二定位位置，在所述注射针头安装到所述胰岛素笔的过程中，利用胰岛素笔头部对针座(2)产生的轴向推力迫使座盘(23)在主壳体(3)内从第一定位位置沿轴向向前移动至第二定位位置，从而使针座(2)与主壳体(3)之间形成滑动定位的连接关系；在第一定位位置上座盘(23)的外缘与主壳体(3)的内缘通过第一定位结构进行配合，在第二定位位置上座盘(23)的外缘与主壳体(3)的内缘通过第二定位结构进行配合；所述第一定位结构采用凹凸定位结构、弹性定位结构或者摩擦定位结构；所述第二定位结构采用凹凸定位结构、弹性定位结构、摩擦定位结构、卡锁定位结构或者端面抵靠定位结构；
    所述主壳体(3)筒体侧壁上设有卡口(38)，卡口(38)在主壳体(3)轴向上对应第二定位位置布置，该卡口(38)为一个贯穿主壳体(3)内外壁之间的通孔，对应该通孔在外护套(8)套筒内壁上设有卡块(81)，在外护套(8)套装主壳体(3)状态下卡块(81)卡入卡口(38)并伸入主壳体(3)内，使外护套(8)与主壳体(3)锁定连接；当座盘(23)从第一定位位置移动至第二定位位置时，座盘(23)外缘顶起外护套(8)上的卡块(81)，使外护套(8)发生变形，最终导致卡块(81)与卡口(38)脱扣，从而实现外护套(8)与主壳体(3)解锁，在此状态下允许摘除外护套(8)。
  2. 根据权利要求1所述的注射针头，其特征在于：所述外护套(8)的套筒内壁上沿轴向设有向内突出的筋条(82)，当外护套(8)套装在主壳体(3)外侧后，外护套(8)内壁与主壳体(3)外壁之间留有供外护套(8)发生变形的间隙。
  3. 根据权利要求1所述的注射针头，其特征在于：所述主壳体(3)的卡口(38)处设有向前端方向延伸的滑槽(39)，以有利于卡块(81)与卡口(38)脱离。
  4. 根据权利要求1所述的注射针头，其特征在于：所述凹凸定位结构由设在座盘(23)外缘圆周方向的凹沟(21)与设在主壳体(3)内缘上的凸筋(33)配合形成。
  5. 根据权利要求1所述的注射针头，其特征在于：所述弹性定位结构由弹性珠销与凹陷配合形成，弹性珠销和凹陷两者中，一者设在座盘(23)外缘上，另一者设在主壳体(3)内缘上。
  6. 根据权利要求1所述的注射针头，其特征在于：所述摩擦定位结构由座盘(23)外缘与主壳体(3)内缘摩擦配合形成。
  7. 根据权利要求1所述的注射针头，其特征在于：所述卡锁定位结构由座盘(23)外缘及前后侧端面与主壳体(3)内缘上所设的卡槽(34)配合形成。
  8. 根据权利要求1所述的注射针头，其特征在于：所述端面抵靠定位结构由座盘(23)外缘的前侧端面与主壳体(3)内缘的内端面抵靠配合形成。
  9. 根据权利要求1所述的注射针头，其特征在于：所述针座(2)上设有座杆(24)，座杆(24)位于座盘(23)前端并与座盘(23)固定连接，座杆(24)上设有凸部(22)，座盘(23)上设有两个让位槽(25)；
    所述主壳体(3)筒体内壁中部设有第一卡榫台阶(31)，主壳体(3)筒体内壁前端设有第二卡榫台阶(35)，主壳体(3)筒体内壁后部设有第三卡榫台阶(37)，主壳体(3)筒体内壁前部设有防退槽(36)；
    在所述主壳体(3)内设有尾盖(1)、前套管(4)、触发管(5)以及弹簧(7)；
    所述尾盖(1)由一个盖帽(15)和两个前腿(16)组成，盖帽(15)为端盖或环状体，盖帽(15)的中央设有仅供针体(6)连接段穿插的让针孔(17)，让针孔(17)轴线与主壳体(3)轴线平行，两个前腿(16)固定连接在盖帽(15)前端上，并且以让针孔(17)轴线为基准对称布置，每个前腿(16)的内侧在根部位置上设有斜面(12)，在中部位置上设有向内延伸的挡块(13)，在末端位置上设有触脚钩(11)；每个前腿(16)的外侧在中部位置上设有尖角卡榫(14)；
    所述前套管(4)的主体结构为管体，前套管(4)的前端内侧设有内端面(44)；前套管(4)的后端设有向后延伸的弹性卡榫(41)和向后延伸的弹性尾翼(43)，弹性卡榫(41)与弹性尾翼(43)在前套管(4)周向错开布置；前套管(4)的中部外侧设有向外延伸的凸起(42)，凸起(42)和弹性卡榫(41)在前套管(4)周向位置对应，凸起(42)靠弹性卡榫(41)一侧设有倾斜面(45)；
    所述触发管(5)的主体结构为管体，触发管(5)的后端设有向后延伸的两个插头(52)，插头(52)上设有倒钩，触发管(5)管体内设有凹部(51)；
    在使用前装配状态下，所述座盘(23)处于主壳体(3)内第一定位位置，尾盖(1)位于主壳体(3)后端内，尾盖(1)上的盖帽(15)位于座盘(23)后方用于保护针体(6) 的连接段，尾盖(1)上的两个前腿(16)穿过座盘(23)上的两个让位槽(25)伸向前方；所述前套管(4)位于主壳体(3)内，前套管(4)上的弹性卡榫(41)卡在主壳体(3)上的第一卡榫台阶(31)上，限制前套管(4)相对主壳体(3)向前运动，同时尾盖(1)两个前腿(16)上的触脚钩(11)勾在前套管(4)的弹性卡榫(41)上；所述触发管(5)位于主壳体(3)前端内并延伸至前端外，用于保护针体(6)的注射段，触发管(5)的后部套装在针座(2)的座杆(24)上，触发管(5)的后部位于前套管(4)内，触发管(5)的前端接近或顶靠在外护套(8)的前部内端面上，触发管(5)上的凹部(51)卡在座杆(24)的凸部(22)上形成定位；所述弹簧(7)一端抵靠在尾盖(1)两个前腿(16)的挡块(13)上，另一端抵靠在前套管(4)的内端面(44)上；
    在使用中，当所述注射针头安装到所述胰岛素笔时，胰岛素笔的头部推动尾盖(1)向前移动，尾盖(1)的触脚钩(11)被前套管(4)凸起(42)上的倾斜面(45)顶起，之后越过凸起(42)，同时尾盖(1)的斜面(12)压迫弹性卡榫(41)向内弯曲，最终迫使弹性卡榫(41)与第一卡榫台阶(31)脱钩，解除前套管(4)在主壳体(3)内向前运动的限位，此时在弹簧(7)的推动下前套管(4)向前移动，直到凸起(42)被触脚钩(11)拦截而停止移动并对前套管(4)向前运动进行限位；与此同时，尾盖(1)上的盖帽(15)抵靠针座(2)的座盘(23)并推动座盘(23)从第一定位位置向前移动至第二定位位置，此时座盘(23)外缘顶起外护套(8)上的卡块(81)，使卡块(81)与卡口(38)脱扣，导致外护套(8)与主壳体(3)解锁，在此状态下允许摘除外护套(8)；同时，由于触发管(5)前端顶靠在外护套(8)的前部内端面上，当针座(2)向前移动时，针座(2)上的凸部(22)与触发管(5)上的凹部(51)之间的定位被解锁；接着，当触发管(5)的前端与人体皮肤接触时，触发管(5)向后移动，此时触发管(5)上的插头(52)顶起尾盖(1)上的挡块(13)，迫使尾盖(1)的触脚钩(11)与前套管(4)的凸起(42)渐渐分离，直到完全分离后在弹簧(7)的推动下前套管(4)向前移动，并伸出主壳体(3)前端，前套管(4)的前端面受阻于人体皮肤，与触发管(5)前端面平齐并一起运动，直到针完全进入人体皮肤后开始注射胰岛素；
    在使用后从人体皮肤拔出所述注射针头时，前套管(4)被弹簧(7)推出主壳体(3)前端，直到前套管(4)上的凸起(42)被主壳体(3)上的第二卡榫台阶(35)拦截而停止向前伸出，此时前套管(4)用来保护针体(6)的注射段；同时前套管(4)的弹性尾翼(43)伸展后卡入主壳体(3)的防退槽(36)中形成前套管(4)向后移动的限位，防止前套管(4)回退；
    在使用后从所述胰岛素笔头部拆除所述注射针头时，尾盖(1)在弹簧(7)推动下向后移动，同时尾盖(1)上的两个挡块(13)夹持住触发管(5)上的插头(52)，并带动触发管(5)向后移动，直到针座(2)上的座杆(24)前端低靠触发管(5)前部内端面而停 止；接着，尾盖(1)上的尖角卡榫(14)落入主壳体(3)的第三卡榫台阶(37)形成尾盖(1)向前移动的限位，而触发管(5)插头(52)的倒钩与两个挡块(13)配合，用来限制尾盖(1)在主壳体(3)后端内向后移动，此时尾盖(1)用来保护针体(6)的连接段，同时防止所述注射针头被二次使用。
PCT/CN2016/078038 2015-04-28 2016-03-31 一次性安全型胰岛素注射针头 WO2016173367A1 (zh)

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