WO2013127259A1 - 一种针头回拉式可换针安全自毁注射器 - Google Patents

一种针头回拉式可换针安全自毁注射器 Download PDF

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Publication number
WO2013127259A1
WO2013127259A1 PCT/CN2013/000190 CN2013000190W WO2013127259A1 WO 2013127259 A1 WO2013127259 A1 WO 2013127259A1 CN 2013000190 W CN2013000190 W CN 2013000190W WO 2013127259 A1 WO2013127259 A1 WO 2013127259A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
annular
locking
wall
pullback
Prior art date
Application number
PCT/CN2013/000190
Other languages
English (en)
French (fr)
Inventor
王祖扬
Original Assignee
Wang Zuyang
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 Wang Zuyang filed Critical Wang Zuyang
Priority to EP13754406.0A priority Critical patent/EP2821090B1/en
Priority to US14/381,908 priority patent/US20150133860A1/en
Priority to JP2014559062A priority patent/JP5921727B2/ja
Publication of WO2013127259A1 publication Critical patent/WO2013127259A1/zh
Priority to IN8091DEN2014 priority patent/IN2014DN08091A/en
Priority to ZA2014/07061A priority patent/ZA201407061B/en

Links

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
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • 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
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3221—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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
    • A61M5/502—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston
    • 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
    • A61M2005/3104—Caps for syringes without needle
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • A61M2005/31508—Means for blocking or restricting the movement of the rod or piston provided on the piston-rod
    • 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
    • A61M2005/3206—Needle or needle hub disconnecting devices forming part of or being attached to the hub or syringe 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
    • 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
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3221—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3223—Means impeding or disabling repositioning of used needles at the syringe nozzle
    • A61M2005/3224—Means to disalign the needle tip and syringe nozzle
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • 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
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw

Definitions

  • the present invention relates to the technical field of medical devices, and more particularly to a needle pullback type needle changeable self-destructing syringe, and more particularly to a mechanical connection structure thereof.
  • the core rod body has a certain elasticity, wherein the longitudinal notch is narrow and wide, and the outer wall of the upper core rod of the lateral notch protrudes from the outer wall of the lower core rod, and the lateral gap can be
  • the outer part is low in inner shape
  • the end of the core rod is formed in an arc shape
  • the upper needle seat is formed in a cylindrical shape
  • the upper part of the outer wall of the upper needle seat is provided with a reinforcing wing piece
  • the lower part of the outer wall of the upper needle seat is provided with a fixing needle ring of the upper needle seat
  • the outer diameter of the fixing convex ring is larger than the outer wall diameter of the upper needle seat by 0.05 mm - 0.3 mm
  • the lower needle seat is cylindrical
  • the inner cavity is hollow
  • the inner wall of the lower needle seat cavity is provided with a lower needle seat annular fixing groove
  • the annular fixing groove of the lower needle seat can cooperate with the fixing convex ring of the upper needle seat
  • the inner wall of the cylinder neck of the cylinder body is respectively provided with a cylinder neck upper limit ring and a cylinder neck lower limit ring, and the distance between the cylinder neck upper limit ring and the cylinder neck lower limit ring is o.3 mm - 1.5 mm, the cylinder neck upper limit position
  • the ring protrudes from the inner wall of the upper end ring of the cylinder neck and the lower limit ring of the cylinder neck by 0.1mm - 0.6mm
  • the limit ring protrudes from the inner wall of the upper end ring of the cylinder neck and the lower limit ring of the cylinder neck to 0.02 mm - 0.25 mm
  • the inner wall of the upper cylinder of the upper cylinder of the upper end of the cylinder neck is between the upper limit ring of the inner cylinder and the lower limit ring of the neck
  • the inner wall of the cylinder at the lower part of the rib is provided with a convex rib in the cylinder, the distance between the limiting rib of the cylinder and the rib in the cylinder is the thickness of the annular limiting piece, and the inner diameter of the limiting rib of the cylinder is smaller than that of the annular limiting piece. diameter.
  • the core rod includes a core rod body, the upper end portion of the core rod body is provided with a columnar fastener, and the columnar fastener is sleeved with a rubber plug, wherein the rubber plug is provided with a mounting hole, and the mounting hole is provided with a pouring Hook body.
  • the function of retracting the needle by using the barb body is realized, and safety injection is realized.
  • the barb body is a metal piece or a plastic piece.
  • Metal parts need to be processed and matched or assembled with the core rod.
  • the manufacturing process is complicated, difficult and not stable, which not only increases the processing steps and manufacturing costs, but also increases the safety and product quality of the metal parts themselves and their assembly process. Uncertainty in terms of hidden dangers.
  • Existing plastic barbs still have defects or imperfections in structure, which leads to safety hazards or safety holes in the use of the product.
  • the existing plastic inverted fastener design can realize the needle pullback function, but in use, the needle is still in a normal trajectory after being pulled back, and the needle may be pushed out again, causing the user to be damaged twice.
  • the existing single needle seat back-pull safety self-destructing syringe or safety syringe has the same problem, that is, how to solve the stability of the inner needle seat and the cylinder and achieve a certain strength to meet the stability.
  • sexual requirements At the same time, the required pulling force when retracting the needle holder should not be too large for convenient use.
  • the rigid mating structure can achieve a stable locking effect on the inner needle seat and the inner wall of the cylinder, it is difficult or even impossible to achieve the convenience of use at the same time.
  • the inherent instability of the plastic material and its susceptibility to changes in ambient temperature can result in poor stability of the product of the hard-fit structure, and the quality and precision of the production process are difficult to control, making it almost impossible to achieve mass production.
  • the needle holder in the syringe and the syringe barrel are locked to each other by an elastic buffer engagement mechanism. Clever use of the engaging parts
  • the cushioning gap and the plasticity of the engaging members perfectly achieve the locking and disengaging effects of the two.
  • the elastic buffering and engaging mechanism can be disposed at the inner needle seat or at the inner wall of the cylinder; no matter what way, as long as the corresponding and mutual engagement mechanism is formed at the inner needle seat or the inner wall of the cylinder Just fine.
  • the end of the core rod is provided with an elastic locking function, and the locking member can be locked with the inner cavity of the syringe needle seat by means of engagement.
  • a needle pullback type needle changeable safety self-destructing syringe comprises a cylinder body; an inner needle seat body is arranged in the cylinder neck of the end of the cylinder body; a core rod is arranged in the cylinder body; and the rubber rod is sleeved near the end portion of the core rod.
  • the utility model is characterized in that: an elastic buffer limit engagement mechanism is formed between the cylinder neck and the inner needle seat body, and the elastic buffer limit engagement mechanism can be disposed at the outer wall of the inner needle hub or at the inner wall of the cylinder neck.
  • the present invention discloses a needle pullback type needle changeable safety self-destructing syringe.
  • the end of the syringe core rod is provided with an elastic pull-back locking member with elastic function; the asymmetric structure is matched with the elastic function design, and the BJ ensures that the locking member can be smoothly inserted into the inner cavity of the needle seat and utilizes the function of elastic expansion.
  • the inner sleeve type pull-back locking component engaging portion of the two sides of the asymmetric engaging portion and the needle socket inner cavity are locked and locked.
  • annular groove design of the inner sleeve type pull-back locking assembly has elastic buffering characteristics, when it is in contact with the asymmetric pull-back locking member in time, both of them will generate relative buffer deformation, so that the locking member can be inserted into the inner sleeve. Retracting the inner cavity of the locking assembly; locking the locking member with the inner sleeve type when the locking member is retracted.
  • the needle seat When the needle holder is pulled back into the syringe barrel, under the force of the asymmetric force, the needle seat will be deflected to one side, and the needle will be inverted toward the inner wall of the cylinder in the direction of nearly forty-five degrees.
  • the asymmetric elastic pull-back locking member is a plastic barb.
  • the plastic barb body adopts a design principle of asymmetry and an elastomer structure, and the specific angle and size design make the barb body have an elastic buffer locking function.
  • the above asymmetric elastic pull-back locking member is integrated with the core rod, and the integral part is formed by one-time open molding, which does not require separate processing or subsequent assembly, thereby effectively reducing manufacturing cost and simplifying assembly. Process, reducing the assembly process.
  • the asymmetric elastic pull-back piece at the end of the core rod has excellent engagement and locking effect on the inner cavity of the needle seat, and the overall structure of the product is reasonable, the concept is clever, the operation is simple, the working state is stable, and the utility model is easy to popularize and apply.
  • the design has significant technical breakthroughs, and has outstanding safety and practical features.
  • FIG. 1 is a schematic structural view of the present invention.
  • FIG. 2 is a schematic structural view of a replaceable needle base of the present invention.
  • FIG. 3 is a schematic view of the body structure of the inner needle seat of the present invention.
  • FIG. 4 is a partial enlarged view of FIG. 3.
  • FIG. 5 is a plan view of FIG. 3.
  • FIG. 6 is a schematic structural view of an inner sleeve type pull-back locking assembly according to the present invention.
  • FIG. 7 is a schematic view showing the structure of a cylinder of the present invention.
  • FIG. 8 is a view of FIG. 7A-A.
  • FIG. 9 is a schematic view showing the structure of a core rod of the present invention.
  • FIG. 10 is a schematic structural view of a barb body according to the present invention.
  • FIG. 11 is a schematic view showing the assembly structure of the inner needle seat body and the inner sleeve type [Hi pull lock assembly.
  • FIG. 13 is a second use state diagram of the present invention.
  • 15 is a fourth use state diagram of the present invention.
  • 16 is a fifth use state diagram of the present invention.
  • 17 is a sixth use state diagram of the present invention.
  • the present invention is a needle pullback type needle changeable safety self-destructing syringe. It comprises a tubular body; cylindrical neck portion 2 equipped with the end barrel 3 has a inner needle hub body; 1 cartridge equipped with the stem 5; 5 near the stem has a plug at the socket end portion 6.
  • an elastic buffer limit engagement mechanism is formed between the neck 2 and the inner needle body 3; the elastic buffer limit engagement mechanism can be disposed on the outer wall of the inner needle body 3 or can be disposed At the inner wall of the neck 2 .
  • the elastic buffer limit engagement mechanism enables the inner needle seat body and the cylinder body to Achieving the requirements of stable engagement, and achieving the effect of light exit.
  • the elastic buffer limit engagement mechanism is disposed at the inner needle seat body 3.
  • the inner body of the inner needle seat body 3 is hollow, and the inner sleeve type pull-back locking assembly 4 is disposed in the cavity; or the inner needle seat body 3 is sleeved with a jacket type pull-back locking assembly.
  • the upper part of the inner needle body 3 forms a replaceable needle fitting portion 7; the lower portion of the inner needle seat body 3 forms an elastic sealing limit portion 8; the replaceable needle fitting portion 7 and the elastic sealing limit portion 8 are formed into a single unitary structure .
  • An annular buffer gap 9 is formed on the surface of the elastic sealing limiting portion 8; an outer sealing portion 8 of the elastic sealing limiting portion 8 on the outer side of the annular buffering gap 9 forms an annular sealing limit engaging portion 10; and an outer wall of the elastic sealing limiting portion 8 is provided Anti-side rotation ribs 13.
  • the outer spiral fitting portion 11 is formed at the interchangeable needle fitting portion 7.
  • the end of the core rod 5 is provided with an asymmetric elastic locking pullback member.
  • the elastic buffer limit engagement mechanism is disposed at the inner hub body 3.
  • the inner body of the inner needle seat body 3 is hollow, and the inner sleeve type pull-back locking assembly 4 is disposed in the cavity; or the inner needle seat body 3 is sleeved with a jacket type pull-back locking assembly.
  • the upper part of the inner needle body 3 is formed with a replaceable pin fitting portion 7; the lower portion of the inner needle seat body 3 forms an elastic sealing limit portion 8; the replaceable needle fitting portion 7 and the elastic sealing limit portion 8 are assembled in a component manner.
  • An annular buffer gap 9 is formed on the surface of the elastic sealing limiting portion 8; an outer sealing portion 8 of the elastic sealing limiting portion 8 on the outer side of the annular buffering gap 9 forms an annular sealing limit engaging portion 10; and an outer wall of the elastic sealing limiting portion 8 is provided Anti-side rotation ribs 13.
  • the outer spiral fitting portion 11 is formed at the interchangeable needle fitting portion 7.
  • the end of the core rod 5 is provided with an asymmetric elastic locking pullback member.
  • the asymmetric elastic locking pullback member has a center axis of symmetry of the core rod, wherein each of the two sides of the shaft forms a locking locking portion, and the locking locking portions on both sides are An asymmetrical shape; the one side engaging locking portion is higher or lower than the other side engaging locking portion; the width of the one side engaging locking portion is larger or smaller than the other side engaging locking portion; Or the engaging locking portions on both sides have an elastic structure; the distance between the outer edge of the engaging locking portion of the one side and the symmetrical center line of the rod body is lmm-20 mm.
  • the above structure can realize that the pull-back member has an elastic structure in whole or in part, can be smoothly inserted into the body of the needle holder, and is completely engaged with the needle-backing body.
  • the asymmetric snap locking structure can apply an asymmetrical force to the needle seat, so that the needle seat will deflect to one side after entering the barrel body cavity, thereby achieving safe operation of the syringe.
  • the asymmetric elastic locking pullback member is a barb body 12.
  • the barb body 12 is made of plastic material; and is integrated with the core rod 5; The consistent performance of the material ensures the stability of the overall locking and locking function of the core rod.
  • the integrated structure can omit the assembly process, improve production efficiency and reduce manufacturing costs.
  • the lower end of the barb body 12 forms a base 14; the upper portion of the base portion 14 forms a first folding arm 15 that is deflected to one side; the connection between the first folding arm 15 and the base portion 14
  • the outer side wall defines a concave arcuate corner 16 or a chamfer angle of 45 to 179 degrees.
  • the lower end of the first folding arm 15 is connected to the upper end of the base portion 14; the upper end of the first folding arm 15 is connected to the second folding arm 17 end, and the other end of the second folding arm 17 is suspended.
  • the outer side of the junction of the first folding arm 15 and the second folding arm 17 forms a circular arc surface 18, and the inner side of the junction of the first folding arm 15 and the second folding arm 17 forms an inner angle 39 of 2 to 90 degrees.
  • the width of the opening between the floating end of the second folding arm 17 and the first folding arm 15 is 0.5 mm - 40 mm; the length of the first folding arm 15 is 0.5 mm - 50 mm; the length of the second folding arm 17 It is 0.5mm - 60mm.
  • the hanging end of the second folding arm 17 forms a thorn tip 24, and the hanging end of the second folding arm 17 protrudes from the outer edge of the base portion 14.
  • the limit flap 22 is connected to the rib 21 by at least two contacts 23. After the syringe is assembled, the top end of the limit flap 22 just presses up against the lower end of the barrel to prevent external force from being applied before the syringe is used, causing the core rod to move forward, causing the syringe to be accidentally scrapped. In use, simply bend the limit flap 22 along the contact to fold it away from the rib 21.
  • the outer spiral mounting portion 11 of the interchangeable needle fitting portion 7 is screwed with a replaceable needle holder 24, and the needle holder 25 is provided at the center of the upper end of the needle exchange seat 24, and the needle holder can be replaced.
  • a cylindrical cavity 30 communicating with the needle tube 25 is formed in the inside of 24.
  • the inner wall of the inner cavity of the interchangeable needle holder 24 is formed with an inner spiral fitting portion 31 which cooperates with the outer spiral fitting portion 11; the upper portion of the cylindrical cavity 30 has a truncated cone shape, and the taper body has a taper of 6:100. This taper ensures the sealing performance of the assembly and is an internationally accepted parameter.
  • the outer wall of the elastic sealing limiting portion 8 is uniformly distributed with an anti-side rotation rib 13 in an annular shape, and the end portion of the anti-side rotation rib 13 has a semi-arc shape or a tapered shape.
  • the upper portion of the interchangeable needle fitting portion 7 has a truncated cone shape with a taper of 6:100.
  • the lower outer wall of the interchangeable needle fitting portion 7 forms an outer spiral fitting portion 1 1, which is capable of ensuring the sealing performance of the assembly and is an internationally accepted parameter.
  • an excessive distance between the interchangeable needle fitting portion 7 and the elastic seal limiting portion 8 forms an annular step 26 or an annular slope.
  • the annular buffer gap 9 is an integral annular groove structure, or a non-integral annular segmented structure.
  • the height from the notch to the bottom of the groove is 0.05mm-4mm ; the width of the annular buffer gap 9 is 0.05mm-4mm; the outer groove wall of the annular buffer gap 9 and the surface of the annular seal limit engaging portion 10 are curved
  • the distance between the top of the arc is 0.1mm-6mm; the distance between the groove of the outer groove wall of the annular buffer gap 9 and the outer wall of the annular seal limiting engagement portion 10 is 0.1mm-6mm; the outer groove wall of the annular buffer gap 9
  • the distance between the bottom of the groove and the outer wall of the annular seal limiting engagement portion 10 is 0.1 mm to 6 mm.
  • the surface of the annular seal limiting engaging portion 10 is curved, and the distance from the surface of the annular sealing limit engaging portion 10 to the edge of the curved surface is smaller than the distance from the top of the arc to the lower edge of the curved surface.
  • An annular recess 27 is formed at an outer wall of the elastic seal limiting portion 8 at the lower portion of the annular seal limiting engagement portion 10.
  • the annular recess 27 is located on the same horizontal surface as the groove bottom of the annular buffer gap 9 or above the groove bottom of the annular buffer gap 9.
  • annular sealing ring fitting groove 28 is formed at an outer wall of the elastic sealing limiting portion 8 of the lower portion of the annular step 26, and the annular sealing ring fitting groove 28 is sleeved with an "O" shape. Sealing rubber ring 29.
  • the barrel neck 2 of the barrel 1 is externally sleeved with a barrel sheath 32 for protecting the end portion of the barrel and the end portion of the inner needle holder.
  • the inner wall of the cylinder neck 2 of the cylinder 1 is provided with an annular seal limiting recess 33 that cooperates with the annular seal limiting engagement portion 10.
  • the depth of the annular seal limiting recess 33 is 0.01 mm to 4 mm ; the height of the annular seal limiting recess 33 is 0.01 mm to 6 mm.
  • the bottom of the recess of the annular seal limiting recess 20 is curved, and the inner wall of the lower portion of the annular neck of the annular seal limiting recess 33 forms a reverse anti-side rib 34 which cooperates with the anti-side rib 13 .
  • At least one inner needle seat annular limiting groove 35 is formed in the inner wall of the inner needle seat body 3, and the inner needle seat body 3 is provided with an inner sleeve type pull-back locking component 4, and the inner sleeve At least one of the limiting collars 36 that cooperate with the inner needle ring annular limiting groove 35 is disposed at the outer wall of the pull-back locking assembly 4.
  • the inner sleeve type pull-back locking assembly 4 has a hollow inner cavity, and an inner wall of the inner cavity forms an annular locking locking portion 38 near the lower end opening, and the annular locking locking portion has a certain buffering.
  • Elastic function when the above-mentioned asymmetric elastic locking pullback member is in contact with it during the advancing process, both of them will elastically deform and deform under the action of the interaction force, so that the asymmetric elastic locking pullback member is facilitated during the advancement process. Smoothly pass over the ring-shaped snap lock.
  • the annular groove 37 is formed in an upper portion of the annular engagement locking portion 38.
  • the inner side wall 40 of the annular groove 37 has a thickness of 0.01 mm to 3 mm : the inner side wall of the annular groove (37) forms an angle of 2 to 90 degrees with the outer side wall 41 of the annular groove 37; and the upper end of the inner side wall of the annular groove 37 is formed.
  • the inner diameter is from 1 mm to 80 mm.
  • the interchangeable needle base is rotated into the end of the inner needle seat body, and the two are combined in a spiral structure and a 6:100 taper structure to achieve a sealed assembly. Effect. After the liquid is sucked, the injection is started, and the core rod is slowly advanced. Since the total width of the asymmetric elastic locking pullback member is larger than the inner diameter of the annular groove 37 at the inner sleeve type pull back locking assembly, the asymmetric elastic lock back after the two touches. The side of the pull member is deformed so that the width is narrowed and then enters the inner cavity of the inner sleeve type pull-back locking assembly.
  • the asymmetric elastic locking pullback member When the asymmetric elastic locking pullback member enters the inner cavity, the force is lost, and the asymmetric elastic locking pullback member returns to the original state; after the injection is completed, the core rod is pulled backward, and the asymmetric elastic locking pullback member (the barb body)
  • the side end of the first-folding end of the folding arm is just inserted into the annular groove of the inner sleeve type pull-back locking assembly; under the action of the pulling force of the core rod, the pulling force is transmitted to the inner needle seat body through the inner sleeve type pull-back locking assembly
  • the annular buffer gap at the elastic seal limit portion of the inner needle seat body is deformed by force; as the annular buffer gap is narrowed, the annular seal limit engagement portion slides from the annular seal limit recess at the cylinder body Finally, the entire needle head is pulled into the lumen of the barrel.
  • the needle seat Under the action of the asymmetric elastic locking pull-back member, the needle seat will deflect the needle to one side and disengage from the normal displacement track, so it can not be assembled into the neck again, and the safe self-destruct operation of the syringe is realized.

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Abstract

一种针头回拉式安全自毁注射器，它包括筒体（1），所述筒体（1）端部的筒颈（2）内设有内针座本体（3），筒颈（2）与内针座本体（3）之间形成弹性缓冲限位机构，其注射器芯杆（5）的端部设有带弹性功能的非对称回拉锁定件，弹性功能可实现与针座内腔的外套式回拉锁定组件卡合并锁定，在非对称作用力的受力环境下，针座会在回拉入筒体（1）后向一侧形成偏转，注射针因此会以近四十五角方向倒向筒体（1）内壁一侧，并被筒体颈部锁定，由此导致注射针及针座无法被再次推出筒体颈部，有效防止针头被推出造成的二次损伤，真正实现注射器的安全自毁操作。所述的非对称弹性回拉锁定件为一塑料倒钩体（12），其与芯杆成一次开模成型。

Description

一种针头回拉式可换针安全自毁注射器 技术领域
[0001] 本发明涉及医疗器械的技术领域， 具体的说是一种针头回拉式可换针安 全自毁注射器， 特别涉及其机械连接结构。
背景技术
[0002] 对比文件一， 专利号： ZL200710047077.4, 申请日： 2007.10.16, 公告号: CN101411908, 专利权人： 上海顶尖堂生化科技有限公司， 本案公开了 "一种安 全自毁式疫苗注射器"， 包括筒体， 筒体内设有芯杆， 芯杆靠近端部处设有胶塞， 筒体的筒颈内设有针头， 针头处设有针管， 其特征在于： 所述芯杆端部的杆体侧 壁设有横向缺口，横向缺口与芯杆端部杆体处的纵向缺口相联通，横向缺口与纵 向缺口相配合， 针头由上针座和下针座套接而成， 下针座内腔中空， 下针座成筒 状结构， 下针座相对于安装上针头座的另一端幵口处内壁设有下针头座凸筋， 芯 杆端部设有由横向缺口和纵向缺口联通而形成的弹性体，此处的芯杆杆体具有一 定的弹性， 其中纵向缺口呈上窄下宽状，而横向缺口外部开口处上部芯杆杆体外 壁凸出于此处下部芯杆杆体外壁，横向缺口可为外高内低状，芯杆端部成圆弧状， 上针座成柱体状， 上针座外壁上段设有加强翼片，上针座外壁下段设有上针座固 定凸环， 上针座固定凸环的外直径大于上针座外壁直径 0.05mm— 0.3mm, 所述 下针座成柱体状， 其内腔中空， 下针座腔体内壁处设有下针头座环形固定凹槽， 下针头座环形固定凹槽可与上针座固定凸环相配合，下针头座环形固定凹槽上部 腔体的内径小于上针座固定凸环上部杆体外壁外径 0.1mm— 0.35mm,下针头座 环形固定凹槽下部腔体的内径 上针座固定凸环下部杆体外壁外径，下针座相对 于下针头座凸环的另一端外壁端部处设有下针头座环形凸筋，所述筒体的筒颈内 壁处分别设有筒颈上限位环和筒颈下限位环，筒颈上限位环和筒颈下限位环之间 的距离为 o.3mm— 1.5mm, 筒颈上限位环凸出于筒颈上限位环和筒颈下限位环 之间内壁 0.1mm— 0.6mm，筒颈下限位环凸出于筒颈上限位环和筒颈下限位环之 间内壁 0.02mm— 0.25mm，筒颈上限位环上部筒体内腔的内径 筒颈上限位环和 筒颈下限位环之间筒体内腔的内径，筒颈上限位环和筒颈下限位环之间筒体内腔 的内径 筒颈下限位环下部筒体内腔的内径，筒颈上限位环和筒颈下限位环之间 筒体内腔的内径小于下针头座环形凸筋外径 0.1mm— 0.5mm，筒体内腔相对于筒 颈的另一端内壁处设有筒体限位筋， 筒体限位筋可为线性环形筋、多条竖筋构成 的环形筋、 一条竖筋、 多个凸起点构成的环形筋， 筒体限位筋下部的筒体内壁处 设有筒体内凸筋， 筒体限位筋与筒体内凸筋之间的距离 环形限位片的厚度，筒 体限位筋处的内径小于环形限位片的直径。
[0003] 对比文件二， 专利号： ZL200720067715.4, 申请日： 2007.03.08, 公告号: CN201076648, 专利权人： 上海顶尖堂生化科技有限公司， 本案公开了 "一种带 有金属钩件结构的芯杆"， 包括芯杆体， 芯杆体的上端部设有柱状扣件， 柱状扣 件处套接有胶塞， 其特征在于： 所述胶塞处设有安装孔， 安装孔内设有倒钩体。
[0004] 现有安全注射器结构中有利用倒钩体实现针头回缩的功能， 实现安全注 射。 一般倒钩体为金属件或塑料件。金属件需要加工并与芯杆配合或组装， 制作 工艺复杂， 难度大且稳定性不佳， 不但增加了加工工序和制造成本， 而且金属件 本身及其装配过程会增加产品在安全性及产品质量方面的隐患等不确定性。现有 塑料倒钩件在结构上仍存在缺陷或有不完善的地方，因此导致产品在使用过程中 存在安全隐患或安全漏洞。现有的塑料倒扣件设计， 虽能实现针头回拉功能， 但 在使用中，针头被回拉后仍然处于正常轨迹，针头有可能被再次推出造成使用者 被二次损伤的风险。
[0005] 另外， 现有的单针座回抽式安全自毁式注射器或安全注射器均存在同一 个难题，就是如何解决内针座与筒体之间卡合稳定并达到一定的强度以符合稳定 性要求； 同时， 在回抽针座时所需拉力不能太大以方便使用。硬性配合结构虽然 能达到内针座与筒体内壁稳定的锁定效果，但很难甚至是无法同时达到方便使用 的需求。塑料材料本身存在的不稳定性和易受环境温度变化的特性会导致硬配合 结构的产品稳定性极差，生产过程中质量和精度都难以控制， 几乎无法实现批量 生产。
[0006] 综上所述， 仍然需要对现有回拉式注射器的芯杆结构和内针座与筒体之 间的锁定结构进行进一步改进，以进一步完善产品在使用过程中的安全性和稳定 性， 同时达到简化加工工序， 降低制造成本的目的。
发明内容
[0007] 本发明的目的在于提供一种针头回拉式可换针安全自毁注射器。 注射器 内针座与注射器筒体之间通过弹性缓冲卡合机构相互锁定。巧妙运用卡合部位的 缓冲间隙和卡合部件的可塑性，完美实现两者的锁定和脱离效果。该弹性缓冲卡 合机构可设置于内针座处， 亦可设置于筒体内壁处； 无论采用何种方式， 只要同 时在内针座或筒体内壁处形成相对应和相互配合的卡合机构即可。芯杆端部设有 带弹性功能的非对称锁定件，该锁定件可与注射器针座内腔通过卡合方式相互锁 定。 当针座被回拉至注射器筒体内时， 在非对称弹性结构的力量作用下， 针座会 受力顺势向一侧偏转； 注射针也因此会向近四十五角方向倒向筒体内壁一侧； 当 注射针完全退回筒体后，针头会被筒体颈部锁定， 由此导致注射针及针座无法被 再次推出筒体外，有效防止针头被再次推出造成的二次损伤， 实现注射器的安全 自毁操作， 克服了现有技术中存在的缺点和不足。
[0008] 为了实现上述目的， 本发明的第一技术方案是： 一种针头回拉式可换针 安全自毁注射器。 它包括筒体； 所述筒体端部的筒颈内设有内针座本体； 筒体内 设有芯杆； 芯杆靠近端部处套接有胶塞。其特征在于： 筒颈与内针座本体之间形 成弹性缓冲限位卡合机构， 该弹性缓冲限位卡合机构可设置丁内针座本体外壁 处， 亦可设置于筒颈内壁处。
[0009] 本发明公开了一种针头回拉式可换针安全自毁注射器。 其注射器芯杆的 端部设有带弹性功能的非对称回拉锁定件； 非对称性结构配合弹性功能设计， BJ 确保该锁定件能顺利插入针座内腔， 并利用其弹性扩张的功能， 实现两侧非对称 卡合部与针座内腔的内套式回拉锁定组件卡合部卡合并锁定。由于内套式回拉锁 定组件内腔的环形凹槽设计也具有弹性缓冲特性，当与非对称回拉锁定件在推进 状态触及时，两者都会产生相对的缓冲变形，便于锁定件卡入内套式回拉锁定组 件内腔； 在锁定件回抽时与内套式回拉锁定组件相互锁定。当针座被回拉至注射 器筒体内时， 在非对称作用力的受力环境下， 针座会受力向一侧偏转， 注射针会 因此向近四十五角方向倒向筒体内壁一侧； 当注射针完全退回筒体后，针头会被 筒体颈部锁定， 由此导致注射针及针座无法被再次推出筒体外，有效防止针头被 再次推出造成二次损伤，真正实现注射器的安全自毀操作。在本发明具体实施时， 所述的非对称弹性回拉锁定件为一塑料倒钩体。该塑料倒钩体采用非对称性和弹 性体结构巧妙配合的设计原理，运用特定的角度和尺寸设计，使得倒钩本体具备 弹性缓冲锁定功能。上述非对称弹性回拉锁定件与芯杆成一体结构， 整体部件采 用一次开模成型， 无需单独加工或后续装配， 有效降低了制造成本， 简化了装配 工艺，减少了装配工序。芯杆端部的非对称弹性回拉件与针座内腔的卡合锁定效 果极佳， 产品整体结构合理， 构思巧妙， 操作使用简单， 工作状态稳定， 易于推 广应用。相比现有产品设计和技术而言， 设计上具有显著的技术性突破， 并具有 突出的安全性和实用性特点。
附图说明
[0010] 图 1为本发明结构示意图。
[0011] 图 2为本发明可换针座结构示意图。
[0012] 图 3为本发明内针座本体构示意图。
[0013] 图 4为图 3的局部放大图。
[0014] 图 5为图 3的俯视图。
[0015] 图 6为本发明内套式回拉锁定组件结构示意图。
[0016] 图 7为本发明筒体结构示意图。
[0017] 图 8为图 7A-A视图。
[0018】 图 9为本发明芯杆结构示意图。
[0019] 图 10为本发明倒钩体结构示意图。
[0020] 图 11为内针座本体与内套式 [Hi拉锁定组件装配结构示意图。
[0021] 图 12为本发明第一使用状态图。
[0022] 图 13为本发明第二使用状态图。
[0023] 图 14为本发明第三使用状态图。
[0024] 图 15为本发明第四使用状态图。
[0025] 图 16为本发明第五使用状态图。
[0026] 图 17为本发明第六使用状态图。
具体实施方式
[0027] 下面参照附图， 对本发明进一步进行描述。
[0028] 本发明为一种针头回拉式可换针安全自毁注射器。 它包括筒体 1 ; 所述 筒体 1端部的筒颈 2内设有内针座本体 3 ; 筒体 1内设有芯杆 5; 芯杆 5靠近端 部处套接有胶塞 6。 其区别于现有技术在于： 筒颈 2与内针座本体 3之间形成弹 性缓冲限位卡合机构；该弹性缓冲限位卡合机构可设置于内针座本体 3外壁处亦 可设置与筒颈 2内壁处。该弹性缓冲限位卡合机构使得内针座本体与筒体间既能 达到稳定卡合的要求， 又能实现轻便退出的效果。
[0029] 在本发明具体实施例中，所述弹性缓冲限位卡合机构设置于内针座本体 3 处。 该内针座本体 3内腔中空， 腔体内设有内套式回拉锁定组件 4; 或者， 内针 座本体 3外部套接有外套式回拉锁定组件。所述内针座本体 3上部形成可换针装 配部 7; 内针座本体 3的下部形成弹性密封限位部 8; 可换针装配部 7和弹性密 封限位部 8成一体式单体结构。 弹性密封限位部 8表面开设有环状缓冲间隙 9; 环状缓冲间隙 9外侧的弹性密封限位部 8外壁形成环状密封限位卡合部 10; 弹 性密封限位部 8外壁处设有防侧旋凸筋 13。 可换针装配部 7处形成外螺旋紋装 配部 11。 芯杆 5的端部设有非对称弹性锁定回拉件。
[0030] 在本发明另一具体实施例中， 所述弹性缓冲限位卡合机构设置于内针座 本体 3处。该内针座本体 3内腔中空，腔体内设有内套式回拉锁定组件 4; 或者， 内针座本体 3外部套接有外套式回拉锁定组件。所述内针座本体 3上部形成可换 针装配部 7; 内针座本体 3的下部形成弹性密封限位部 8; 可换针装配部 7和弹 性密封限位部 8成分体式装配结构。弹性密封限位部 8表面开设有环状缓冲间隙 9； 环状缓冲间隙 9外侧的弹性密封限位部 8外壁形成环状密封限位卡合部 10; 弹性密封限位部 8外壁处设有防侧旋凸筋 13。 可换针装配部 7处形成外螺旋紋 装配部 11。 芯杆 5的端部设有非对称弹性锁定回拉件。
[0031] 在具体实施时， 所述非对称弹性锁定回拉件以芯杆的对称中心线为中轴， 其中轴的两侧各形成一卡合锁定部，且两侧的卡合锁定部呈非对称状；所述一侧 卡合锁定部高于或低于另一侧卡合锁定部；所述一侧卡合锁定部的宽度大于或小 于另一侧卡合锁定部； 所述一侧或两侧的卡合锁定部具有弹性结构； 所述一侧的 卡合锁定部外侧边缘与杆体的对称中心线之间的距离为 lmm-20mm。 上述结构 可实现回拉件整体或部分具有弹性结构， 能顺利卡入针座腔体内，并在回抽时与 之完全卡合。非对称卡合锁定结构能对针座施加非对称作用力，使得针座在进入 筒体内腔后会向一侧偏转， 实现注射器的安全操作。
[0032] 在具体实施时， 所述非对称弹性锁定回拉件为一倒钩体 12。 所述倒钩体 12为塑料材质； 且与芯杆 5部成一体结构； 一次开模成型。 材料的一致性能确 保芯杆整体卡合锁定功能的稳定性， 一体结构能省略装配工序， 提高生产效率， 降低制造成本。 [0033] 在具体实施时， 所述倒钩体 12下端形成基座 14; 基座部 14上部形成向 一侧偏转的第一折臂 15 ; 第一折臂 15与基座部 14的连接处外侧壁形成内凹状 的圆弧角 16或折角， 该圆弧角呈 45度至 179度。 第一折臂 15的下端与基座部 14的上端连接； 第一折臂 15的上端与第二折臂 17—端连接， 第二折臂 17另一 端悬空。 第一折臂 15与第二折臂 17连接处的外侧形成圆弧面 18， 第一折臂 15 与第二折臂 17连接处的内侧形成 2度至 90度的内夹角 39。第二折臂 17的悬空 端与第一折臂 15之间形成开口的宽度为 0.5mm— 40mm; 所述第一折臂 15的长 度为 0.5mm— 50mm; 所述第二折臂 17的长度为 0.5mm— 60mm。 所述第二折臂 17的悬空端形成刺尖 24， 且第二折臂 17的悬空端突出于基座部 14外侧边缘。
[0034] 在具体实施时， 所述芯杆 5处形成四片十字形等夹角分布的加强筋 21， 加强筋 21外边缘处设有限位折片 22。所述限位折片 22与加强筋 21之间通过至 少两个触点 23连接。注射器装配完成后， 限位折片 22的顶端刚好向上抵住筒体 下端， 防止注射器使用之前受到外力作用， 导致芯杆向前位移， 导致注射器意外 报废。 使用时， 只需沿着触点弯折限位折片 22 , 便可将其从加强筋 21处折去。
[00351 在具体实施时， 所述可换针装配部 7的外螺旋纹装配部 1 1处旋接有可换 针座 24， 可换针座 24上端中心位设有针管 25， 可换针座 24内形成与针管 25 联通的柱状腔体 30。 可换针座 24内腔的内壁处形成与外螺旋纹装配部 11相配 合的内螺旋纹装配部 31 ; 柱状腔体 30上部呈圆台体状， 该圆台体的锥度为 6: 100。 该锥度能确保装配的密封性能， 为国际通用参数。
[0036] 在具体实施时， 所述弹性密封限位部 8 外壁处呈环状均匀分布有防侧旋 凸筋 13， 所述防侧旋凸筋 13的端部呈半圆弧状或锥状。
[0037] 在具体实施时， 所述可换针装配部 7上部呈圆锥台状， 其锥度为 6: 100。 可换针装配部 7的下部外壁形成外螺旋纹装配部 1 1， 该锥度能确保装配的密封 性能， 为国际通用参数。
[0038] 在具体实施时， 所述可换针装配部 7与弹性密封限位部 8之间的过度处 形成环状台阶 26或环状坡面。
[0039] 在具体实施时， 所述环状缓冲间隙 9 为整体环形槽结构， 或者非整体环 状的分段式结构。其槽口至槽底的高度为 0.05mm-4mm; 环状缓冲间隙 9的宽度 为 0.05mm-4mm; 环状缓冲间隙 9外侧槽壁与环状密封限位卡合部 10表面弧面 弧顶的距离为 0.1mm-6mm; 环状缓冲间隙 9外侧槽壁槽口处与环状密封限位卡 合部 10外壁之间的距离为 0.1mm-6mm;环状缓冲间隙 9外侧槽壁槽底处与环状 密封限位卡合部 10外壁之间的距离为 0.1 mm-6mm。 环状密封限位卡合部 10的 表面成弧面状， 环状密封限位卡合部 10表面弧顶至弧面上边缘的距离小于弧顶 至弧面下边缘的距离。 所述环状密封限位卡合部 10下部的弹性密封限位部 8外 壁处形成环状凹陷 27。
[0040] 在具体实施时， 所述环状凹陷 27与环状缓冲间隙 9的槽底位于同一水平 面或高于环状缓冲间隙 9的槽底。
[0041 J 在具体实施时， 所述环状台阶 26下部的弹性密封限位部 8外壁处形成环 状密封圈装配凹槽 28， 环状密封圈装配凹槽 28内套接有 "O"形密封胶圈 29。
[0042| 在具体实施时， 所述筒体 1的筒颈 2外部套接有筒体护套 32， 用于保护 筒体端部和内针座端部结构。
[0043] 在具体实施时， 所述筒体 1 的筒颈 2内壁处设有与环状密封限位卡合部 10相配合的环状密封限位凹陷 33。环状密封限位凹陷 33的深度为 0.01mm-4mm; 环状密封限位凹陷 33的高度为 0.01mm-6mm。环状密封限位凹陷 20的凹陷底部 成弧面状，环状密封限位凹陷 33下部的筒颈 2内壁处形成与防侧旋凸筋 13相配 合的反向防侧旋凸筋 34。
[00441 在具体实施时， 所述内针座本体 3 腔体内壁处形成至少一内针座环形限 位槽 35， 内针座本体 3腔体内设有内套式回拉锁定组件 4， 内套式回拉锁定组件 4外壁处至少设置一与内针座环形限位槽 35相配合的限位凸环 36。
[0045] 在具体实施时， 所述内套式回拉锁定组件 4 内腔中空， 其内腔内壁靠近 下端开口处形成环状卡合锁定部 38， 该环状卡合锁定部具有一定的缓冲弹性功 能， 当上述非对称弹性锁定回拉件在推进过程中与之触及时，两者均会在相互作 用力的作用下发生弹性缓冲变形，如此便于非对称弹性锁定回拉件在推进过程中 顺利掠过环状卡合锁定部。
[0046] 在具体实施时， 所述环状卡合锁定部 38的上部形成该环形凹槽 37。环形 凹槽 37 内侧壁 40的厚度为 0.01mm-3mm: 环形凹槽 （37 ) 内侧壁与环形凹槽 37外侧壁 41形成 2度至 90度夹角； 环形凹槽 37内侧壁上端处形成的内直径为 l mm-80mm。 上述技术参数确保了环状卡合锁定部 38具备弹性缓冲功能， 尤其 体现在外侧壁 41处。在具体实施时，所述环形凹槽 37的槽口宽度大于槽底宽度。
[0047] 当非对称弹性锁定回拉件滑入内套式回拉锁定组件 4 内后， 向后拉动芯 杆， 非对称弹性锁定回拉件的一侧端部（倒钩体第二折臂的悬空端）刚好卡在环 形凹槽 37内， 导致芯杆端部与内套式回拉锁定组件 4完全咬合。
[0048] 在实际操作中， 如图 12至图 17中所示， 将可换针座旋转入内针座本体 端部， 两者在螺旋纹结构和 6: 100锥度结构的配合下， 实现密封装配的效果。 吸液后开始注射，将芯杆缓缓推进， 由于非对称弹性锁定回拉件的总宽度大于内 套式回拉锁定组件处环形凹槽 37内径， 故两者触及后， 非对称弹性锁定回拉件 一侧变形，使得宽度变窄后进入内套式回拉锁定组件内腔。当非对称弹性锁定回 拉件进入内腔后，失去受力效果，非对称弹性锁定回拉件恢复原状；注射完成后， 向后拉动芯杆， 该非对称弹性锁定回拉件（倒钩体第—折臂的悬空端）侧端刚好 卡在内套式回拉锁定组件的环形凹槽内；在芯杆拉力的作用下，拉力通过内套式 回拉锁定组件传导至内针座本体处，内针座本体的弹性密封限位部处环状缓冲间 隙受力变形； 随着环状缓冲间隙变窄，环状密封限位卡合部从筒体处的环状密封 限位凹陷内滑出，最后整个针头部被拉入筒体内腔。在非对称弹性锁定回拉件的 作用下， 针座会带动针头向一侧偏转， 脱离正常位移轨迹， 故无法再次装配到筒 颈内， 实现注射器的安全自毁操作。
10049] 以上内容是结合具体的优选实施方式对本发明所作的进一步详细说明， 不能认定本发明具体实施只局限于上述这些说明。对于本发明所属技术领域的普 通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干简单推演或替 换， 都应当视为属于本发明的保护范围。

Claims

权 利 要 求 书
1. 一种针头回拉式可换针安全自毀注射器， 它包括： 筒体 （1); 所述筒体 （1) 端部的筒颈 （2) 内设有内针座本体（3); 筒体（1) 内设有芯杆（5); 芯杆（5) 靠近端部处套接有胶塞 （6), 其特征在于： 筒颈 （2) 与内针座本体 （3)之间形 成弹性缓冲限位卡合机构。
2. 根据权利要求 1所述的一种针头回拉式可换针安全自毁注射器， 其特征在于: 所述弹性缓冲限位卡合机构设置于内针座本体（3)处， 该内针座本体（3) 内腔 中空， 腔体内设有内套式回拉锁定组件 （4)， 或者， 内针座本体 （3) 外部套接 有外套式回拉锁定组件， 所述内针座本体 （3) 上部形成可换针装配部 （7)， 内 针座本体（3) 的下部形成弹性密封限位部（8)， 可换针装配部（7)和弹性密封 限位部（8)成一体式单体结构， 弹性密封限位部（8)表面开设有环状缓冲间隙
(9), 环状缓冲间隙（9)外侧的弹性密封限位部（8)外壁形成环状密封限位卡 合部 （10)， 弹性密封限位部 （8) 外壁处设有防侧旋凸筋 （13), 可换针装配部
(7) 处形成外嫘旋纹装配部 （11)， 芯杆 （5) 的端部设有非对称弹性锁定回拉 件。
3. 根据权利要求 1所述的一种针头回拉式可换针安全自毁注射器， 其特征在于: 所述弹性缓冲限位卡合机构设置于内针座本体（3)处， 该内针座本体（3) 内腔 中空， 腔体内设有内套式回拉锁定组件 （4); 或者， 内针座本体 （3) 外部套接 有外套式回拉锁定组件， 所述内针座本体 （3) 上部形成可换针装配部 （7)， 内 针座本体（3) 的下部形成弹性密封限位部（8)， 可换针装配部（7)和弹性密封 限位部（8)成分体式装配结构， 弹性密封限位部（8)表面开设有环状缓冲间隙
(9), 环状缓冲间隙（9)外侧的弹性密封限位部（8)外壁形成环状密封限位卡 合部 （10)， 弹性密封限位部 （8) 外壁处设有防侧旋凸筋 （13)， 可换针装配部
(7) 处形成外螺旋纹装配部 （11)， 芯杆 （5) 的端部设有非对称弹性锁定回拉 件。
4. 根据权利要求 2所述的一种针头回拉式可换针安全自毁注射器， 其特征在于 : 所述非对称弹性锁定回拉件以芯杆的对称中心线为中轴，其中轴的两侧各形成一 卡合锁定部， 且两侧的卡合锁定部呈非对称状；所述一侧卡合锁定部高于或低于 另一侧卡合锁定部； 所述一侧卡合锁定部的宽度大于或小于另一侧卡合锁定部； 所述一侧或两侧的卡合锁定部具有弹性结构；所述一侧的卡合锁定部外侧边缘与 杆体的对称中心线之间的距离为 lmm-20mm。
5. 根据权利要求 2所述的一种针头回拉式可换针安全自毁注射器， 其特征在于： 所述非对称弹性锁定回拉件为一倒钩体 （12), 所述倒钩体 （12) 为塑料材质； 与芯杆 （5 ) 部成一体结构； 一次开模成型。
6. 根据权利要求 5所述的一种针头回拉式可换针安全自毁注射器， 其特征在于： 所述倒钩体 （12) 下端形成基座部 （14); 基座部 （14) 上部形成向一侧偏转的 第一折臂 （15 ); 第一折臂 （15 ) 与基座部 （14) 的连接处外侧壁形成内凹状的 圆弧角 （16) 或折角， 该圆弧角呈 45度至 179度； 第一折臂 （15 ) 的下端与基 座部（14) 的上端连接， 第一折臂 （15 ) 的上端与第二折臂 （17) 端连接， 第 二折臂 （Π) 另一端悬空； 第一折臂 （15 )与第二折臂（Π)连接处的外侧形成 圆弧面 （18)， 第一折臂 （15 ) 与第二折臂 （17) 连接处的内侧形成 2 度至 90 度的内夹角 （39 ); 第二折臂 （17) 的悬空端与第一折臂 （15 ) 之间形成开口的 宽度为 0.5mm— 40mm; 所述第一折臂 （15 ) 的长度为 0.5mm— 50mm; 所述第 二折臂 （17) 的长度为 0.5mm— 60mm。
7. 根据权利要求 1所述的一种针头回拉式可换针安全自毁注射器， 其特征在于： 所述芯杆（5)处形成四片十字形等夹角分布的加强筋 （21 )， 加强筋 （21 )外边 缘处设有限位折片 （22)。
8. 根据权利要求 7所述的一种针头回拉式可换针安全自毁注射器， 其特征在于： 所述限位折片 （22) 与加强筋 （21 ) 之间通过至少两个触点 （23 ) 连接。
9. 根据权利要求 6所述的一种针头回拉式可换针安全自毁注射器， 其特征在于: 所述第二折臂 （Π) 的悬空端形成刺尖 （24)， 且第二折臂 （Π) 的悬空端突出 于基座部 （14) 外侧边缘。
10. 根据权利要求 2所述的一种针头回拉式可换针安全自毀注射器，其特征在于： 所述可换针装配部（7) 的外螺旋纹装配部（Π )处旋接有可换针座（24)， 可换 针座 （24 ) 上端中心位设有针管 （25 ), 可换针座 （24) 内形成与针管 （25 ) 联 通的柱状腔体（30)， 可换针座（24) 内腔的内壁处形成与外螺旋纹装配部（11 ) 相配合的内螺旋纹装配部 （31 )， 柱状腔体 （30) 上部呈圆台体状， 该圆台体的 锥度为 6: 100。
11. 根据权利要求 2所述的一种针头回拉式可换针安全自毁注射器,其特征在于: 所述弹性密封限位部（8〉外壁处呈环状均匀分布有防侧旋凸筋（13)， 所述防侧 旋凸筋 （13 ) 的端部呈半圆弧状或锥状。
12. 根据权利要求 2所述的一种针头回拉式可换针安全自毁注射器，其特征在于： 所述可换针装配部 （7) 上部呈圆锥台状， 其锥度为 6: 100， 可换针装配部 （7) 的下部外壁形成外螺旋纹装配部 （11 )。
13. 根据权利要求 2所述的一种针头回拉式可换针安全自毁注射器,其特征在于: 所述可换针装配部（7)与弹性密封限位部（8)之间的过度处形成环状台阶（26) 或环状坡面。
14. 根据权利要求 2所述的一种针头回拉式可换针安全自毁注射器，其特征在于： 所述环状缓冲间隙 （9) 为环形槽结构， 其槽口至槽底的高度为 0.05mm-4mm， 环状缓冲间隙（9) 的宽度为 0.05mm-4mm， 环状缓冲间隙（9)外侧槽壁与环状 密封限位卡合部 （10) 表面弧面弧顶的距离为 0.1mm-6mm， 环状缓冲间隙 （9) 外侧槽壁槽口处与环状密封限位卡合部 （10) 外壁之间的距离为 0.1mni-6rnm， 环状缓冲间隙 （9) 外侧槽壁槽底处与环状密封限位卡合部 （10) 外壁之间的距 离为 0.1mm-6mm, 环状密封限位卡合部 （10) 的表面成弧面状， 环状密封限位 卡合部（10)表面弧顶至弧面上边缘的距离小于弧顶至弧面下边缘的距离， 所述 环状密封限位卡合部（ 10)下部的弹性密封限位部（8)外壁处形成环状凹陷（27)。
15. 根据权利要求 14所述的一种针头回拉式可换针安全自毀注射器， 其特征在 于： 所述环状凹陷 （27) 与环状缓冲间隙 （9) 的槽底位于同一水平面或高于环 状缓冲间隙 （9) 的槽底。
16. 根据权利要求 13所述的一种针头回拉式可换针安全自毁注射器， 其特征在 于： 所述环状台阶 （26) 下部的弹性密封限位部 （8) 外壁处形成环状密封圈装 配凹槽 （28)， 环状密封圈装配凹槽 （28) 内套接有 "0"形密封胶圈 （29)。
17. 根据权利要求 1所述的一种针头回拉式可换针安全自毁注射器,其特征在于： 所述筒体 （1 ) 的筒颈 （2) 外部套接有筒体护套 （32)。
18. 根据权利要求 1所述的一种针头回拉式可换针安全自毁注射器,其特征在于： 所述筒体（1 ) 的筒颈（2) 内壁处设有与环状密封限位卡合部（10)相配合的环 状密封限位凹陷 （33 )， 环状密封限位凹陷 （33) 的深度为 0.01mm-4mm, 环状 密封限位凹陷（33 ) 的高度为 0.0】mm-6mm， 环状密封限位凹陷 （20) 的凹陷底 部成弧面状， 环状密封限位凹陷 （33 ) 下部的筒颈 （2) 内壁处形成与防侧旋凸 筋 （Π ) 相配合的反向防侧旋凸筋 （34)。
19. 根据权利要求 1所述的一种针头回拉式可换针安全自毁注射器，其特征在于： 所述内针座本体（3 )腔体内壁处形成至少一内针座环形限位槽（35 )， 内针座本 体（3 )腔体内设有内套式回拉锁定组件（4)， 内套式回拉锁定组件（4)外壁处 至少设置一与内针座环形限位槽 （35 ) 相配合的限位凸环 （36)。
20.根据权利要求 2所述的一种针头回拉式可换针安全自毁注射器，其特征在于 : 所述内套式回拉锁定组件 （4) 内腔中空， 其内腔内壁靠近下端开口处形成环状 卡合锁定部 （38)。
21. 根据权利要求 20所述的一种针头回拉式可换针安全自毁注射器， 其特征在 于- 所述环状卡合锁定部 （38) 的上部形成环形凹槽 （37)， 环形凹槽 （37) 内 侧壁（40) 的厚度为 0.01ιηηι-3ηηη， 环形凹槽 （37) 内恻壁与环形凹槽（37 )外 侧壁 （41 ) 形成 2度至 90度夹角， 环形凹槽 （37) 内侧壁上端处形成的内直径 为 lmm-80mm。
22. 根据权利要求 21 所述的一种针头回拉式可换针安全自毁注射器， 其特征在 于： 所述环形凹槽 （37) 的槽口宽度大于槽底宽度。
PCT/CN2013/000190 2012-02-29 2013-02-26 一种针头回拉式可换针安全自毁注射器 WO2013127259A1 (zh)

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