Pre-filled syringe

Abstract

The utility model relates to a pre-filled syringe which comprises a needle head pre-assembly and a container pre-assembly. The needle head pre-assembly is formed by pre-assembling a hard protective cap, a soft protective cap, a needle tube seat and a sealing gasket; the needle tube seat is formed by combining a needle tube and a seat body, the needle tube is inserted into the soft protective cap, and the soft protective cap is assembled in the hard protective cap; a locking groove and a sealing groove are formed in a seat body of the needle tube seat, and a sealing gasket is embedded in the sealing groove; the container pre-assembly is formed by pre-assembling a piston, a core rod, a needle head protection sleeve and an outer sleeve; the piston and the core rod are connected together and installed in the medicine containing cavity of the outer sleeve. A needle head protection sleeve is arranged outside the lower part of the outer sleeve; a mounting head is arranged at the bottom of the outer sleeve, and a buckle is arranged on the mounting head; the installation head is inserted into the needle tube seat, and the buckle is clamped into the sealing groove, so that the needle head pre-assembly and the container pre-assembly are assembled together. The device is simple in structure and easy to manufacture and assemble; the use process is convenient to operate, and the needle head can be protected.

Description

Technical Field

[0001] The utility model relates to a prefilled syringe for medical injection, belonging to the field of medical syringes. Background Art

[0002] A prefilled syringe (Prefilled Syringe, PFS), also known as a pre-filled syringe, is a new form of liquid drug packaging that combines "drug storage" and "injection function"; a prefilled syringe is a syringe with a drug and a needle built in, which eliminates the transfer step of the drug from the package to the syringe barrel, effectively reducing waste caused by adsorption, and avoiding cross-contamination and secondary contamination of the drug; prefilled syringes have been widely recognized and applied in the pharmaceutical industry, especially in the field of biological products.

[0003] For example, in a prefilled glass syringe with the Chinese patent publication number CN102068735A, in existing prefilled syringes, the needle is generally pre-assembled on the syringe barrel. After being delivered to a pharmaceutical company, the pharmaceutical company fills the syringe barrel with a medicament, and then assembles a piston and a piston rod to achieve sealing.

[0004] However, after such prefilled syringes are used, the needles are exposed; if one wants to achieve the effect of protecting and shielding the needles, a special needle protection device needs to be equipped for use, increasing the use cost to a certain extent.

[0005] Therefore, it is necessary to make certain improvements to the structure of the prefilled syringe, in order to facilitate shielding the needle after use, prevent accidental injury to the operator, or cause needle contamination. Summary of the Utility Model

[0006] The purpose of the utility model is to provide a prefilled syringe, which is delivered in the form of a needle pre-assembly and a container pre-assembly. After filling the medicament in the container pre-assembly, the needle pre-assembly is assembled; after use, by directly operating the needle protection sleeve, the shielding and protection of the needle can be achieved, with simple operation and low overall manufacturing cost; there are no metal parts in the main part of the whole prefilled syringe, and it can be sterilized by irradiation as a whole, improving the safety and reliability of medicament storage and transportation.

[0007] To achieve the above-mentioned utility model purpose, the utility model provides a prefilled syringe, including a needle pre-assembly and a container pre-assembly;

[0008] The needle pre-assembly is pre-assembled together by a hard cap, a soft cap, a needle tube seat and a sealing gasket;

[0009] The needle tube seat is formed by combining a needle tube and a seat body. The needle tube is inserted into the soft cap, and the soft cap is assembled in the hard cap;

[0010] The needle tube seat is provided with a locking groove and a sealing groove in the seat body, and a sealing gasket is embedded in the sealing groove;

[0011] The container pre-assembly is pre-assembled by a piston, a core rod, a needle protection sleeve, and a jacket;

[0012] The piston is connected with the core rod and installed in the medicine-containing cavity of the outer jacket; a needle protection sleeve is installed outside the lower part of the outer jacket;

[0013] A mounting head is provided at the bottom of the jacket, and a buckle is provided on the mounting head;

[0014] The mounting head is inserted into the needle tube seat, and the buckle is snapped into the sealing groove, so that the needle pre-assembly and the container pre-assembly are assembled together.

[0015] As a further improvement of the utility model, the hard protective cap is provided with a cap body, and the inner wall of the cap body is provided with a plurality of barbs;

[0016] The outer wall of the soft protective cap matches the inner wall of the cap body;

[0017] The soft protective cap is installed into the hard protective cap, and the barbs of the hard protective cap are clamped into the outer wall of the soft protective cap.

[0018] Furthermore, the end of the cap body of the hard protective cap is sealed, and a plurality of air holes are opened at the sealed end;

[0019] The opening end of the cap body extends outward to form a supporting wing;

[0020] The barb is arranged near the vent hole.

[0021] As a further improvement of the present invention, the opening end of the seat body of the needle tube seat extends outward to form a blocking wing;

[0022] The opening end of the cap body of the hard protective cap extends outward to form a supporting wing; a side surface of the opening end of the cap body is provided with a giving way groove; and the blocking wing of the needle tube seat is inserted into the giving way groove of the hard protective cap.

[0023] Furthermore, a locking groove is provided in the seat body of the needle tube seat, and the locking groove includes an entry groove, a pressure groove, and a fixing groove, and the three grooves are interconnected;

[0024] The entry groove extends to the open end of the needle tube seat; the pressurizing groove is a spiral groove; the fixed groove is a horizontal groove, which is lower than the pressurizing groove;

[0025] The bottom of the cartridge of the outer sleeve shrinks inwards to form a mounting head, and a protruding buckle is provided on the mounting head;

[0026] After the buckle is inserted into the entry groove of the needle tube seat along the axial direction, it rotates along the pressurizing groove and enters into the fixing groove.

[0027] Further, a sealing groove is provided inside the closed end of the seat body. A syringe fixing sleeve is provided in the sealing groove, and a syringe is connected inside the syringe fixing sleeve. The top of the syringe fixing sleeve is flush with the top of the syringe.

[0028] The sealing gasket is embedded in the sealing groove of the syringe seat.

[0029] After the sealing gasket is installed in place in the sealing groove, in the natural state, the sealing gasket extends beyond the sealing groove, and the top of the sealing gasket is higher than the tops of the syringe fixing sleeve and the syringe.

[0030] When the buckle of the outer sleeve rotates along the pressure groove, the buckle moves in a spiral motion, and the end of the mounting head of the outer sleeve compresses the sealing gasket.

[0031] When the buckle of the outer sleeve reaches the fixing groove, the end of the mounting head of the outer sleeve is flush with the tops of the syringe fixing sleeve and the syringe.

[0032] As a further improvement of the present utility model, the main body of the outer sleeve is a medicine-containing cylinder with openings at both ends. A cylindrical medicine-containing cavity is provided inside the medicine-containing cylinder, and the piston can move to the bottom of the medicine-containing cylinder.

[0033] When the outer sleeve and the syringe seat are assembled together, the end of the mounting head of the outer sleeve is flush with the tops of the syringe fixing sleeve and the syringe, and the end of the medicine-containing cylinder of the outer sleeve is connected to the top of the syringe.

[0034] As a further improvement of the present utility model, the top of the medicine-containing cylinder of the outer sleeve extends outward to form a finger wing.

[0035] As a further improvement of the present utility model, the needle protection sleeve, the main body of which is a protection cylinder with openings at both ends.

[0036] An inner upper part of the protection cylinder extends inward to form a limiting ring. A guiding groove and a passing groove are provided on the limiting ring.

[0037] An elastic slotted opening is provided on the upper part of the wall surface of the protection cylinder to form an elastic claw. The top of the elastic claw extends inward to form a limiting claw. The longitudinal section of the limiting claw is triangular. The top surface of the limiting claw is a horizontal plane to form a limiting surface. The inner side surface of the limiting claw is an inclined surface to form an unlocking inclined surface.

[0038] The guiding groove and the elastic claw are not on the same side, and the passing groove and the elastic claw are on the same side.

[0039] The main body of the outer sleeve is a cylindrical medicine-containing cylinder. A positioning ring extends outward at the middle and lower part of the medicine-containing cylinder.

[0040] A raised guiding strip is provided along the axis on the outer edge of the cylindrical wall at the middle and lower part of the medicine-containing cylinder. The shape and position of the guiding strip match the shape and position of the guiding groove. The guiding strip is snapped into the guiding groove.

[0041] A raised locking block is provided outside the cylindrical wall at the lower part of the medicine-containing cylinder, and the shape and position of the locking block match those of the through slot.

[0042] The open end of the body of the syringe barrel seat extends outward to form a retaining wing.

[0043] Before the needle protection sleeve is used, the positioning ring is located between the unlocking slope of the spring claw and the limit ring.

[0044] When the needle protection sleeve realizes needle protection, the spring claw and the limit ring of the needle protection sleeve are clamped by the locking block of the outer sleeve and the retaining wing of the syringe barrel seat; the protection cylinder of the needle protection sleeve sleeves the syringe barrel, and the bottom of the protection cylinder exceeds the bottom of the syringe barrel.

[0045] Furthermore, the outer sleeve is provided with 2 guiding slots, 2 through slots, and 2 spring claws; there are 2 guiding bars.

[0046] The 2 guiding slots and the 2 through slots are distributed at an interval of 90°.

[0047] Above the through slot is the spring claw.

[0048] The present utility model is delivered to the pharmaceutical manufacturer in the form of a needle pre-assembly and a container pre-assembly. The pharmaceutical manufacturer fills the medicine into the container pre-assembly, and then the needle pre-assembly and the container pre-assembly are assembled together. Specifically, the mounting head of the outer sleeve is inserted into the opening of the syringe barrel seat, the buckle on the mounting head is inserted into the entry slot of the syringe barrel seat, the end of the mounting head abuts against the sealing gasket, and force is applied to rotate the needle pre-assembly relative to the container pre-assembly, that is, the buckle moves along the spiral pressure groove. At this time, the spiral groove drives the buckle together with the container pre-assembly to generate not only a radial rotational movement but also an axial movement, so that the sealing gasket is compressed; finally, the sealing gasket is fully compressed, the medicine-containing cavity of the outer sleeve is communicated with the syringe barrel and is sealed by the sealing gasket, and the buckle enters the fixing groove, so that the outer sleeve and the syringe barrel seat are reliably connected together, that is, the needle pre-assembly and the container pre-assembly are connected together to form the assembled and stored and transported state of the pre-filled syringe of the present utility model, which is convenient for storage and transportation. At this time, the end of the mounting head is flush with the needle fixing sleeve and the top of the syringe barrel.

[0049] When the pre-filled syringe of the present utility model is used:

[0050] Step 1, remove the protective cap; Remove the hard protective cap and the soft protective cap, and then expose the syringe barrel.

[0051] Step 2, insert the needle, inject, and withdraw the needle; Hold the medicine - containing cylinder by hand, insert the syringe into the patient's body; then place the thumb against the pusher head, hook the other fingers on the finger wings, apply force with the palm, so that the rod drives the piston to move in the medicine - containing cavity, and then injects the medicine stored in the medicine - containing cavity into the patient's body through the syringe. Until the piston reaches the bottom of the medicine - containing cavity, the injection is completed. Then, hold the medicine - containing cylinder by hand again and pull out the syringe from the patient's body, and the needle - pulling is completed; in the present utility model, the medicine - containing cavity is a cylindrical tube, so the piston can move all the way to the bottom of the medicine - containing cavity, directly reaching the top of the syringe fixing sleeve and the syringe, and the medicine in the medicine - containing cavity can be completely pushed out, and only the medicine remains in the syringe, thus making full use of the medicine and reducing medicine waste.

[0052] Step 3, needle protection; Hold the needle protection sleeve by hand and move it downward relative to the outer sleeve and the syringe seat until the needle protection sleeve completely wraps the syringe to complete the needle protection.

[0053] Step 3.1 When the needle protection sleeve moves downward, the unlocking inclined surface of the spring claw of the needle protection sleeve contacts the positioning ring, and the spring claw opens outward along the inclined surface until the spring claw passes over the positioning ring;

[0054] Step 3.2 When the needle protection sleeve continues to move downward, the spring claw resets and moves below the positioning ring;

[0055] Step 3.3 When the needle protection sleeve continues to move downward, the unlocking inclined surface of the spring claw of the spring claw contacts the locking block, and the spring claw opens outward along the inclined surface until the spring claw passes over the locking block;

[0056] Step 3.4 When the needle protection sleeve moves downward sufficiently until the spring claw passes over the locking block and resets, at this time, in the upper part, the limiting surface of the spring claw is blocked by the locking block, and in the lower part, the limiting ring is blocked by the blocking wing, that is, the spring claw and the limiting ring of the needle protection sleeve are clamped by the locking block of the outer sleeve and the blocking wing of the syringe seat, and both ends are limited; at this time, the protection cylinder of the needle protection sleeve extends out sufficiently to cover the syringe, and the bottom of the protection cylinder exceeds the bottom of the syringe, realizing needle protection.

[0057] The pre - filled syringe of the present utility model has a simple structure and is easy to manufacture and assemble.

[0058] For the pre - filled syringe of the present utility model, the piston and the core rod are pre - assembled in the medicine - containing cavity of the outer sleeve to form a container pre - assembly, and the medicine can be filled from the medicine - discharging end of the medicine - containing cavity, which is more convenient to operate; the assembly process of the container pre - assembly and the syringe pre - assembly is also convenient to operate.

[0059] When in use, the pre - filled syringe of the present utility model can be directly taken for use, and the injection process is the same as that of a conventional syringe; after the injection is completed, only a simple single - direction movement of the needle protection sleeve is required to achieve needle protection, which is convenient to operate. Brief Description of the Drawings

[0060] Figure 1 This is an exploded view of the components of the prefilled syringe of the present utility model;

[0061] Figure 2 This is a schematic diagram of the overall structure of the needle pre-assembly of the present utility model;

[0062] Figure 3 This is a schematic diagram of the overall structure of the container pre-assembly of the present utility model Figure 1 ;

[0063] Figure 4 This is a schematic diagram of the overall structure of the container pre-assembly of the present utility model Figure 2 ;

[0064] Figure 5 This is a schematic diagram of the state before the needle pre-assembly and the container pre-assembly are assembled;

[0065] Figure 6 This is a schematic diagram of the assembled, stored and transported state of the prefilled syringe of the present utility model Figure 1 ;

[0066] Figure 7 This is a schematic diagram of the assembled, stored and transported state of the prefilled syringe of the present utility model Figure 2 ;

[0067] Figure 8 This is a schematic diagram of the overall structure of the hard protective cap of the present utility model;

[0068] Figure 9 This is a schematic diagram of the internal structure of the hard protective cap of the present utility model;

[0069] Figure 10 This is a schematic diagram of the internal structure of the assembled state of the hard protective cap and the soft protective cap;

[0070] Figure 11 This is a schematic diagram of the overall structure of the needle tube seat of the present utility model;

[0071] Figure 12 This is a semi-sectional view of the needle tube seat of the present utility model;

[0072] Figure 13 This is a schematic diagram of the internal structure of the needle pre-assembly of the present utility model;

[0073] Figure 14 This is a schematic diagram of the assembly process of the piston and the core rod;

[0074] Figure 15 This is a schematic diagram of the overall structure of the needle protection sleeve of the present utility model;

[0075] Figure 16 Internal structure schematic diagram of the needle protection sleeve of the present utility model;

[0076] Figure 17 Top view of the needle protection sleeve of the present utility model;

[0077] Figure 18 Top view of the limiting ring of the needle protection sleeve of the present utility model;

[0078] Figure 19 Overall structure schematic of the outer sleeve of the present utility model Figure 1 ;

[0079] Figure 20 Overall structure schematic of the outer sleeve of the present utility model Figure 2 ;

[0080] Figure 21 Internal structure schematic diagram of the container pre-assembly of the present utility model;

[0081] Figure 22 Internal structure schematic diagram of the assembled, stored and transported state of the pre-filled syringe of the present utility model;

[0082] Figure 23 is Figure 22 Partial enlarged schematic diagram;

[0083] Figure 24 Schematic diagram of the injection preparation state of the pre-filled syringe of the present utility model;

[0084] Figure 25 Schematic diagram of the injection process of the pre-filled syringe of the present utility model;

[0085] Figure 26 Schematic diagram of the syringe after injection of the pre-filled syringe of the present utility model;

[0086] Figure 27 Partial enlarged schematic diagram of the internal structure after injection of the pre-filled syringe of the present utility model;

[0087] Figure 28 Schematic diagram of the start of operation of the needle protection sleeve;

[0088] Figure 29 is Figure 28 Partial enlarged schematic diagram of the internal structure in the state;

[0089] Figure 30 Schematic diagram of the operation process of the needle protection sleeve Figure 1 ;

[0090] Figure 31 Schematic diagram of the operation process of the needle protection sleeve Figure 2 ;

[0091] Figure 32 For Figure 31 the main sectional partial enlarged schematic diagram of the state;

[0092] Figure 33 is the overall structural schematic diagram of the needle protection sleeve in the needle protection state Figure 1 ;

[0093] Figure 34 is the overall structural schematic diagram of the needle protection sleeve in the needle protection state Figure 2 ;

[0094] Figure 35 For Figure 34 the internal structural partial enlarged schematic diagram of the state;

[0095] Figure 36 For Figure 34 the main sectional partial enlarged schematic diagram of the state. Specific embodiments

[0096] The following further describes the specific embodiments of the present utility model in detail with reference to the accompanying drawings.

[0097] As Figure 1 shown, the prefilled syringe of the present utility model includes parts such as a hard cap 1, a soft cap 2, a syringe barrel seat 3, a sealing gasket 4, as well as a piston 5, a core rod 6, a needle protection sleeve 7, and an outer sleeve 8; among them, the hard cap 1, the soft cap 2, the syringe barrel seat 3, and the sealing gasket 4 are pre-assembled together to form a needle pre-assembly 91 as Figure 2 shown; the piston 5, the core rod 6, the needle protection sleeve 7, and the outer sleeve 8 are pre-assembled together to form a container pre-assembly 92 as Figure 3 , Figure 4 shown.

[0098] The needle pre-assembly 91 and the container pre-assembly 92 are delivered to the pharmaceutical manufacturer in the state, and the pharmaceutical manufacturer fills the container pre-assembly 92 with the medicine, that is, as Figure 5 shown; finally, the needle pre-assembly 91 and the container pre-assembly 92 are assembled together, that is, the prefilled syringe of the present utility model is formed, as Figure 6 , Figure 7 shown.

[0099] Hard protective cap 1 , the specific structure is as Figure 8 , Figure 9 As shown, it is injection-molded from plastics such as polypropylene (PP), and is provided with a cap body 11 in a cylindrical or conical shape. The end of the cap body 11 is sealed, and a number of ventilation holes 12 are provided at the sealed end; the open end of the cap body 11 extends outward to form a support wing 13 for convenient gripping and rotating operation; a relief groove 14 is provided on the side of the open end of the cap body 11; a number of barbs 15 are provided on the inner wall of the cap body 11. In this embodiment, the barbs 15 are provided near the ventilation holes 12.

[0100] Soft protective cap 2 , made of polyisoprene-based elastic material, the outer wall matches the inner wall of the cap body 11, and a needle receiving cavity 22 is provided inside; the soft cap 2 is installed into the hard cap 1 to form a combination as shown in Figure 10 As shown, the soft cap 2 has a certain elasticity, and the barbs 15 of the hard cap 1 are stuck into the outer wall of the soft cap 2, so that the two are tightly combined together; especially when removing the cap, only by pulling the hard cap 1 can the soft cap 2 be removed together.

[0101] Syringe barrel base 3 , the specific structure is as shown in Figure 11 、 Figure 12 As shown, it is formed by combining a needle tube 31 and a seat body 32. The needle tube 31 is made of stainless steel-like material, while the seat body 32 is injection-molded from plastics such as polypropylene (PP). The needle tube 31 and the seat body 32 are connected together during injection molding, so the connection is more reliable; the seat body 32 is cylindrical as a whole, and the open end of the seat body 32 extends outward to form a retaining wing 33; a locking groove is provided inside the seat body 32, and the locking groove includes an entry groove 34, a pressurizing groove 35, and a fixing groove 36, and the three grooves are connected; the entry groove 34 extends to the open end to facilitate the entry of the buckle, and the pressurizing groove 35 is a spiral groove; the fixing groove 36 is a horizontal groove, lower than the pressurizing groove 35. A sealing groove 37 is provided on the inner side of the closed end of the seat body 32, and a needle tube fixing sleeve 38 is provided in the sealing groove 37, and the needle tube 31 is connected inside the needle tube fixing sleeve 38; the top of the needle tube fixing sleeve 38 is preferably flush with the top of the needle tube 31.

[0102] Sealing gasket 4 , made of polyisoprene-based elastic material, is an annular gasket and can be installed in the sealing groove 37 of the needle tube seat 3.

[0103] Syringe pre-assembly 91 , the internal structure is as shown in Figure 13 As shown, the syringe holder 3 is inserted into the combined body of the hard cap 1 and the soft cap 2. The syringe 31 is inserted into the needle receiving cavity 22 of the soft cap 2 and is tightly wrapped by the soft cap 2 to achieve sealing. The retaining wing 33 is snapped into the relief groove 14 of the hard cap 1 to achieve positioning. That is, when the hard cap 1 is rotated, the syringe holder 3 can be driven to rotate. The sealing gasket 4 is installed into the sealing groove 37 of the syringe holder 3. After the sealing gasket 4 is installed in place, in its natural state (without external force applied), the sealing gasket 4 protrudes beyond the sealing groove 37, and the top of the sealing gasket 4 is slightly higher than the tops of the syringe fixing sleeve 38 and the syringe 31 by about 0.5 mm.

[0104] Piston 5, plunger rod 6 , such as Figure 14 shown; the piston 5 is generally made of an elastic material such as bromobutyl rubber and is generally a standard part with an installation hole 52 inside; the core rod 6 is generally made of a plastic material with relatively high strength such as polycarbonate (PC), including a slender rod body 61 (with relatively high strength requirements due to mainly bearing force), a relatively large push head 62, and a connecting head 63; the installation hole 52 of the piston 5 matches the connecting head 63 of the core rod 6, and the connecting head 63 is inserted into the installation hole 52, that is, the piston 5 is assembled onto the core rod 6.

[0105] Needle protection sleeve 7 , the specific structure is as Figure 15 、 Figure 16 、 Figure 17 、 Figure 18 shown. It is generally injection molded from a plastic such as polycarbonate (PC), and the main body is a cylinder with openings at both ends, that is, the protection cylinder 71; the upper inner side of the protection cylinder 71 extends inward to form a limiting ring 72, and several openings are provided on the limiting ring 72, including a guiding groove 73 and a passing groove 74; an elastic slotted opening is provided on the upper part of the wall surface of the protection cylinder 71 to form an elastic claw 75, and the top of the elastic claw 75 extends inward to form a limiting claw. The longitudinal section of the limiting claw is triangular, that is, the top surface of the limiting claw is a horizontal plane to form a limiting surface 76, and the inner side surface of the limiting claw is an inclined surface to form an unlocking inclined surface 77. The guiding groove 73 and the elastic claw 75 are not on the same side, and the passing groove 74 and the elastic claw 75 are on the same side; in this embodiment, there are 2 guiding grooves 73, 2 passing grooves 74, and 2 elastic claws 75, among which the guiding groove 73 and the passing groove 74 are distributed at an interval of 90°, and the elastic claw 75 is above the passing groove 74.

[0106] Outer sleeve 8 , the specific structure is as Figure 19 、 Figure 20 As shown, it is generally injection-molded from plastics such as polypropylene (PP). The main body is a cylinder with openings at both ends, namely the medicine-containing cylinder 81. Its interior is a cylindrical medicine-containing cavity 82 for accommodating medicine. The top of the medicine-containing cylinder 81 extends outward to form finger wings 83. The bottom of the medicine-containing cylinder 81 contracts inward to form a mounting head 84, and the mounting head 84 is provided with a protruding buckle 85. At the middle and lower part of the medicine-containing cylinder 81, a positioning ring 86 extends outward. Along the axis on the outer edge of the cylinder wall at the middle and lower part of the medicine-containing cylinder 81, there are two protruding guiding strips 87. The shape and position of the guiding strips 87 match the shape and position of the guiding grooves 73. The positioning ring 86 is connected to the tops of the two guiding strips 87. On the outer side of the cylinder wall at the lower part of the medicine-containing cylinder 81, there are two protruding locking blocks 88. The shape and position of the locking blocks 88 match the shape and position of the through grooves 74.

[0107] Container pre-assembly 92 , the internal structure is as Figure 21 As shown, the piston 5 is assembled onto the core rod 6, and then the whole is inserted into the medicine-containing cavity 82 of the outer sleeve 8. The outer sleeve 8 is inserted into the needle protection sleeve 7. During the process, the guiding strips 87 are snapped into the guiding grooves 73, pushing the spring claws 75 outward to open, crossing over the locking blocks 88, and the through grooves 74 also cross over the locking blocks 88. Finally, the spring claws 75 cross over the positioning ring 86, making the positioning ring 86 located between the unlocking inclined surface 77 of the spring claws 75 and the limit ring 72, holding the outer sleeve 8 on the outer side of the middle and lower part of the needle protection sleeve 7.

[0108] After the needle pre-assembly 91 and the container pre-assembly 92 are delivered to the medicine manufacturer, the medicine manufacturer fills the medicine into the container pre-assembly 92, and then the needle pre-assembly 91 and the container pre-assembly 92 are assembled together. Specifically, the mounting head 84 of the outer sleeve 8 is inserted into the opening of the needle tube seat 3, and the buckle 85 on the mounting head 84 is inserted into the entry groove 34 of the needle tube seat 3. The end of the mounting head 84 abuts against the sealing gasket 4. Applying force, the needle pre-assembly 91 is rotated relative to the container pre-assembly 92, that is, the buckle 85 moves along the spiral pressing groove 35. At this time, the spiral groove drives the buckle 85 together with the container pre-assembly 92 to generate not only a radial rotational movement but also an axial movement, compressing the sealing gasket 4. Finally, the sealing gasket 4 is fully compressed, the medicine-containing cavity 82 of the outer sleeve 8 is in communication with the needle tube 31 and is sealed by the sealing gasket 4, and the buckle 85 enters the fixing groove 36, making the outer sleeve 8 and the needle tube seat 3 reliably connected together, that is, the needle pre-assembly 91 and the container pre-assembly 92 are connected together, forming the assembled and storage / transport state of the pre-filled syringe of the present utility model, which is convenient for storage and transport. At this time, preferably, the end of the mounting head 84 is flush with the top of the needle tube fixing sleeve 38 and the needle tube 31. After assembly, irradiation sterilization can be carried out. Since there are no metal parts outside the medicine-containing cavity 82, reliable irradiation sterilization can be performed.

[0109] The usage process of the prefilled syringe of the present utility model is as follows.

[0110] Step 1, remove the protective cap; As Figure 24 shown, remove the hard protective cap 1 and the soft protective cap 2, thereby exposing the syringe barrel 31.

[0111] Step 2, insert the needle, inject, and withdraw the needle; As Figure 25 、 Figure 26 shown, hold the medicine containing cylinder 81 by hand, insert the syringe barrel 31 into the patient's body; then place the thumb against the push head 62, hook the other fingers on the finger wings 83, apply force with the palm, so that the rod body 61 drives the piston 5 to move in the medicine containing cavity 82, thereby injecting the medicine stored in the medicine containing cavity 82 into the patient's body through the syringe barrel 31. Until the piston 5 reaches the bottom of the medicine containing cavity 82, the injection is completed. You can then hold the medicine containing cylinder 81 by hand and pull out the syringe barrel 31 from the patient's body, thus completing the needle withdrawal; in the present utility model, the medicine containing cavity 82 is a cylindrical barrel, so the piston 5 can move all the way to the bottom of the medicine containing cavity 82, directly against the top of the syringe barrel fixing sleeve 38 and the syringe barrel 31, so that the medicine in the medicine containing cavity 82 can be completely pushed out, and the medicine only remains in the syringe barrel 31, thereby making full use of the medicine and reducing medicine waste.

[0112] Step 3, needle protection; As Figures 28 - 36 shown, hold the needle protection sleeve 7 by hand and move it downward relative to the outer sleeve 8 and the syringe barrel base 3 until the needle protection sleeve 7 completely wraps the syringe barrel 31, completing the needle protection.

[0113] Step 3.1 , as Figure 28 、 Figure 29 shown, when the needle protection sleeve 7 moves downward, the unlocking inclined surface 77 of the spring claw 75 of the needle protection sleeve 7 contacts the positioning ring 86, and the spring claw 75 spreads outward along the inclined surface until the spring claw 75 crosses the positioning ring 86;

[0114] Step 3.2 , as Figure 30 shown, the needle protection sleeve 7 continues to move downward, the spring claw 75 resets, and the spring claw 75 moves below the positioning ring 86;

[0115] Step 3.3 , as Figure 31 、 Figure 32 shown, the needle protection sleeve 7 continues to move downward, the unlocking inclined surface 77 of the spring claw 75 of the spring claw 75 of the needle protection sleeve 7 contacts the locking block 88, and the spring claw 75 spreads outward along the inclined surface until the spring claw 75 crosses the locking block 88;

[0116] Step 3.4 , as Figure 33 、 Figure 34 、 Figure 35 、 Figure 36As shown, the needle protection sleeve 7 moves fully downward until the spring pawl 75 passes over the locking block 88 and resets. At this time, at the upper part, the limiting surface 76 of the spring pawl 75 is blocked by the locking block 88, and at the lower part, the limiting ring 72 is blocked by the blocking wing 33. That is, the spring pawl 75 and the limiting ring 72 of the needle protection sleeve 7 are clamped by the locking block 88 of the outer sleeve 8 and the blocking wing 33 of the syringe barrel seat 3, and both ends are limited. At this time, the protection cylinder 71 of the needle protection sleeve 7 extends fully out, covering the syringe barrel 31, and the bottom of the protection cylinder 71 exceeds the bottom of the syringe barrel 31, achieving needle protection.

[0117] The prefilled syringe of the present utility model has a simple structure and is easy to manufacture and assemble. That is, the piston 5 and the core rod 6 are pre-assembled in the medicine-containing cavity 82 of the outer sleeve 8 to form a container pre-assembly 92, and the medicine can be filled from the medicine-out end of the medicine-containing cavity 82. The assembly process with the syringe barrel pre-assembly 91 is also convenient. When in use, it can be directly taken, and the injection process is the same as that of a conventional syringe. After injection, only a simple single-direction movement of the needle protection sleeve 7 is required to achieve needle protection, and the operation is convenient.

[0118] The preferred embodiments of the present utility model have been specifically described above, but the present utility model is not limited to the described embodiments. Those skilled in the art can make various equivalent modifications or substitutions without departing from the spirit of the present utility model, and these equivalent modifications or substitutions are all included within the scope defined by the claims of this application.

Claims

1. A prefilled syringe, characterized in that: It includes a needle pre-assembly and a container pre-assembly; The needle pre-assembly is pre-assembled by a hard protective cap, a soft protective cap, a needle tube seat, and a sealing gasket; The needle tube seat is formed by combining a needle tube and a seat body, the needle tube is inserted into the soft protective cap, and the soft protective cap is assembled in the hard protective cap; The needle tube seat is provided with a locking groove and a sealing groove in the seat body, and a sealing gasket is embedded in the sealing groove; The container pre-assembly is pre-assembled by a piston, a core rod, a needle protection sleeve, and a jacket; The piston is connected with the core rod and installed in the medicine-containing cavity of the outer jacket; a needle protection sleeve is installed outside the lower part of the outer jacket; A mounting head is provided at the bottom of the jacket, and a buckle is provided on the mounting head; The mounting head is inserted into the needle tube seat, and the buckle is snapped into the sealing groove, so that the needle pre-assembly and the container pre-assembly are assembled together.

2. The prefilled syringe according to claim 1, characterized in that: The hard protective cap is provided with a cap body, and the inner wall of the cap body is provided with a plurality of barbs; The outer wall of the soft protective cap matches the inner wall of the cap body; The soft protective cap is installed into the hard protective cap, and the barbs of the hard protective cap are clamped into the outer wall of the soft protective cap.

3. The prefilled syringe according to claim 2, characterized in that: The end of the cap body of the hard protective cap is sealed, and a plurality of air holes are opened at the sealed end; The opening end of the cap body extends outward to form a supporting wing; The barb is arranged near the vent hole.

4. The prefilled syringe according to claim 1, characterized in that: The opening end of the seat body of the needle tube seat extends outward to form a blocking wing; The opening end of the cap body of the hard protective cap extends outward to form a supporting wing; a side surface of the opening end of the cap body is provided with a giving way groove; and the blocking wing of the needle tube seat is inserted into the giving way groove of the hard protective cap.

5. The prefilled syringe according to claim 4, characterized in that: The needle tube seat is provided with a locking groove in the seat body, and the locking groove includes an entry groove, a pressure groove, and a fixing groove, and the three grooves are interconnected; The entry groove extends to the open end of the needle tube seat; the pressurizing groove is a spiral groove; the fixed groove is a horizontal groove, which is lower than the pressurizing groove; The bottom of the cartridge of the outer sleeve shrinks inwards to form a mounting head, and a protruding buckle is provided on the mounting head; After the buckle is inserted into the entry groove of the needle tube seat along the axial direction, it rotates along the pressurizing groove and enters into the fixing groove.

6. The prefilled syringe according to claim 5, characterized in that: A sealing groove is provided on the inner side of the closed end of the seat body, a needle tube fixing sleeve is provided in the sealing groove, and a needle tube is connected to the needle tube fixing sleeve; the top of the needle tube fixing sleeve is flush with the top of the needle tube; The sealing pad is embedded in the sealing groove of the needle tube seat; After the sealing gasket is installed in place in the sealing groove, in a natural state, the sealing gasket exceeds the sealing groove, and the top of the sealing gasket is higher than the top of the needle tube fixing sleeve and the needle tube; When the buckle of the outer jacket rotates along the pressurized groove, the buckle moves spirally, and the end of the mounting head of the outer jacket compresses the sealing gasket; When the buckle of the outer jacket reaches the fixing groove, the end of the mounting head of the outer jacket is flush with the needle tube fixing sleeve and the top of the needle tube.

7. The prefilled syringe according to claim 1, characterized in that: The main body of the outer jacket is a medicine-containing cartridge with openings at both ends, a cylindrical medicine-containing chamber is arranged in the medicine-containing cartridge, and a piston can move to the bottom of the medicine-containing cartridge; When the outer jacket is assembled with the needle tube seat, the end of the mounting head of the outer jacket is flush with the needle tube fixing sleeve and the top of the needle tube, and the end of the drug containing cartridge of the outer jacket is connected with the top of the needle tube.

8. The prefilled syringe according to claim 1, characterized in that: The top of the cartridge of the outer sleeve extends outward to form a finger wing.

9. The prefilled syringe according to claim 1, characterized in that: The needle protection sleeve has a main body which is a protection tube with openings at both ends; The inner upper part of the protection tube extends inward to form a limiting ring, and the limiting ring is provided with a guide groove and a passing groove; An elastic groove is provided on the upper part of the wall of the protection tube to form an elastic claw, the top of the elastic claw extends inward to form a limiting claw, and the longitudinal section of the limiting claw is a triangle; the top surface of the limiting claw is a horizontal plane to form a limiting surface; the inner side surface of the limiting claw is an inclined plane to form an unlocking inclined plane; The guide groove and the spring claw are not on the same side, but the over groove and the spring claw are on the same side; The outer sleeve has a main body which is a cylindrical cartridge, and the lower middle portion of the cartridge extends outward to form a positioning ring; A raised guide strip is provided along the axis of the outer side of the cylindrical wall at the middle and lower part of the cartridge, and the shape and position of the guide strip match the shape and position of the guide groove; the guide strip is inserted into the guide groove; A protruding locking block is provided on the outer side of the cylindrical wall at the lower part of the drug container, and the shape and position of the locking block match the shape and position of the slot; The opening end of the seat body of the needle tube seat extends outward to form a blocking wing; Before the needle protection sleeve is used, the positioning ring is located between the unlocking inclined surface of the spring claw and the limiting ring; When the needle protection sleeve realizes needle protection, the elastic claw and the limit ring of the needle protection sleeve are clamped by the locking block of the outer sleeve and the retaining wing of the needle tube seat; the protective tube of the needle protection sleeve covers the needle tube, and the bottom of the protective tube exceeds the bottom of the needle tube.

10. The prefilled syringe according to claim 9, characterized in that: The outer jacket is provided with 2 guide grooves, 2 over-grooves, and 2 spring claws; there are 2 guide strips; The two guide grooves and the two over-grooves are spaced 90 degrees apart; Above the slot is a spring claw.

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