Needle press fitting tool for pre-filled syringe with ultra-high viscosity medicine

Abstract

The utility model relates to a needle press -fitting frock of pre -filled syringe for ultrahigh viscosity medicine, including press, be equipped with needle press -fitting frock between the base and upper pressure head of press, needle press -fitting frock includes needle seat, guide rod to and the syringe seat that constitutes by guide seat, sliding seat, connecting seat, pressure seat, needle seat is fixed on the base of press, and the guide rod is fixed on needle seat, and guide seat is worn on the guide rod, sliding seat is connected with connecting seat, and the bottom of sliding seat is set up in the upper portion of guide rod, and connecting seat is connected with the upper pressure head of press, and pressure seat is installed in connecting seat, the needle press -fitting frock of pre -filled syringe for ultrahigh viscosity medicine of the utility model is designed according to the structural characteristics of pre -filled syringe for ultrahigh viscosity medicine, has realized the assembly of needle assembly in the end of syringe cylinder high -efficient, reliable, utilizes pressure spring to adjust the pressure size of press -fitting, makes the press -fitting process safe and reliable.

Description

Technical Field

[0001] This utility model relates to a tooling for press-fitting needles into pre-filled syringes for high-viscosity drugs, and belongs to the field of medical devices. Background Technology

[0002] In the biopharmaceutical field, some pharmaceutical products have high, or even extremely high, viscosity. To facilitate the injection of these drugs, the applicant has specifically designed a syringe suitable for high-viscosity medications, such as... Figure 1 , Figure 2 As shown, a longer and thinner syringe barrel and a thinner needle reduce the diameter contraction ratio from the inside of the syringe barrel to the needle tip, thus facilitating the injection of the drug into the needle. In contrast, pre-filled syringes for these ultra-high viscosity drugs typically require pre-filling with the drug from the end, followed by assembly of the needle assembly after filling. Further details are as follows... Figure 3 As shown, the medication inside the syringe is sealed using a needle.

[0003] To achieve a good seal, the needle component needs to be pressed into the syringe tip with a large force. Therefore, a special needle pressing tool needs to be designed to facilitate the assembly of the needle component. Utility Model Content

[0004] The purpose of this invention is to provide a needle pressing tool for a pre-filled syringe for ultra-high viscosity drugs, which facilitates the pressing of a needle hub into the cavity at the connection end of the syringe barrel, thereby improving the pressing efficiency and yield of the needle assembly.

[0005] To achieve the above-mentioned utility model objectives, this utility model provides a needle pressing fixture for a pre-filled syringe for ultra-high viscosity drugs, including a press machine, with the needle pressing fixture provided between the base and the upper press head of the press machine.

[0006] The needle pressing fixture includes a needle seat, a guide rod, and a syringe seat consisting of a guide seat, a sliding seat, a connecting seat, and a pressure seat;

[0007] The needle holder is fixed to the base of the press, and a guide rod is fixed on the needle holder. The guide seat is sleeved on the guide rod and can move up and down along the guide rod. The sliding seat is connected to the connecting seat, and the bottom of the sliding seat is sleeved on the upper part of the guide rod. The connecting seat is connected to the upper pressure head of the press. The pressure application seat is installed in the connecting seat.

[0008] The needle holder has a needle-accepting hole;

[0009] The guide seat is located above the needle holder. The guide seat has a guide hole and slides with the guide rod. The guide seat has a guide hole that runs through the needle from top to bottom.

[0010] The lower sides of the sliding seat have sliding holes, which are fitted onto the upper part of the guide rod and slide in cooperation with the guide rod; the lower part of the sliding seat has a cylinder mounting groove; the upper part of the sliding seat has a flange mounting groove.

[0011] The connecting seat is fixed above the sliding seat, and the interior of the connecting seat forms a cavity with a pressure seat. The height of the pressure seat is less than the height of the cavity inside the connecting seat, and the pressure seat is slidably installed in the cavity of the connecting seat.

[0012] An adjusting screw hole is provided on the lower side of the top of the connector, and an adjusting screw is installed in the adjusting screw hole;

[0013] The top of the connector is provided with a push rod mounting slot;

[0014] The inner side of the pressure seat is provided with a push rod mounting groove, and the lower side of the push rod mounting groove forms a pressure surface;

[0015] The upper part of the pressure seat is provided with a spring hole, which is a blind hole, and a pressure spring is installed in the spring hole; the top of the pressure spring abuts against the bottom of the adjusting screw;

[0016] The syringe holder body, consisting of a guide seat, a sliding seat, a connecting seat, and a pressure seat, forms an open syringe holder from top to bottom, consisting of a push rod top placement groove, a push rod placement groove, a flange placement groove, and a barrel placement groove. This groove is aligned with the guide hole on the guide seat and the needle receiving hole on the needle holder.

[0017] As a further improvement of this utility model, the syringe mounting slot is provided in two or more sets, and the needle holder is provided with two or more needle receiving holes; the syringe mounting slot and the needle receiving hole correspond one-to-one.

[0018] As a further improvement of this utility model, the upper surface of the needle holder protrudes upward to form a needle holder platform, and a guide hole is provided in the needle holder platform, which extends downward to form a needle receiving hole.

[0019] Furthermore, the guide hole of the guide seat is a multi-stage stepped hole, with a guide cone hole at the top and a guide limiting hole in the middle;

[0020] The lower part of the guide hole is provided with a needle seat that inserts into the guide hole, and the needle seat is connected to the guide limiting hole;

[0021] The inner diameter of the needle holder insertion guide hole is larger than the outer diameter of the needle holder platform, and the needle holder platform can be inserted into the needle holder insertion guide hole.

[0022] As a further improvement of this utility model, two vertical guide rods are fixed on both sides of the needle holder. The guide rod body is cylindrical. The guide rod body has a lower latch and an upper latch at both ends that slide up and down along the guide seat.

[0023] The side of the guide seat has a positioning hole opposite to the guide hole, and a positioner is installed inside it; the positioning end of the positioner matches the lower and upper bayonets.

[0024] Furthermore, the positioning hole is a threaded hole that extends both internally and externally;

[0025] The positioner is a ball screw with a threaded housing that is screwed into a threaded hole.

[0026] The threaded housing is fitted with a protruding or concealable steel ball, and a spring is provided behind the steel ball;

[0027] The ball bearing protrudes from the guide hole wall, and when the ball bearing is hidden, it is completely concealed within the hole wall.

[0028] As a further improvement of this utility model, the middle of the sliding seat is hollowed out to form a cavity.

[0029] Furthermore, the upper part of the sliding seat is provided with an adjusting screw hole, and an adjusting screw is installed in the adjusting screw hole. The adjusting screw is screwed into the adjusting screw hole from bottom to top. The top of the adjusting screw extends beyond the sliding seat, forming a limiting protrusion that abuts against the bottom surface of the pressure seat.

[0030] As a further improvement of this utility model, screw holes are provided on both sides of the connecting seat, and mounting screws are provided in the screw holes;

[0031] The upper two sides of the sliding seat are provided with connecting screw holes;

[0032] Screw the mounting screws into the connecting screw holes to securely connect the sliding seat and the connecting seat.

[0033] Furthermore, the upper part of the screw hole is a countersunk hole, and the head of the screw is recessed into the screw hole.

[0034] The bottom of the screw hole has a stepped countersunk hole; the top of the connecting screw hole of the sliding seat protrudes upward to form a positioning step, which matches the stepped countersunk hole; the positioning step is inserted into the stepped countersunk hole, so that the screw hole and the connecting screw hole are connected.

[0035] As a further improvement of this utility model, guide blocks are provided on both sides of the cavity of the connecting seat;

[0036] The pressure seat has guide grooves on both sides, which match the guide blocks to form a straight guide.

[0037] The needle pressing tooling for the pre-filled syringe for ultra-high viscosity drugs of this invention is used as follows:

[0038] Step 1: Place the pre-filled syringe and insert the syringe barrel (pre-filled with ultra-high viscosity drug, with a piston and push rod inside) into the barrel mounting slot. The flange of the syringe barrel should be inserted into the flange mounting slot, and the part of the push rod extending beyond the syringe barrel should be inserted into the push rod mounting slot. The top of the push rod should be inserted into the push rod top mounting slot. At this time, the bottom connecting end of the syringe barrel will be exposed downwards at the bottom of the sliding seat. At this time, the guide seat will rest on the needle seat.

[0039] Using step two, manually push the guide seat upwards until it locks into the upper bayonet; this allows the guide hole of the guide seat to cover the connecting end; at this point, the ball bearing of the guide seat's positioner will lock into the recess of the upper bayonet, thus leaving the guide seat at the top and exposing the upper surface of the needle seat below.

[0040] Using step three, place the needle assembly into the needle holder platform of the needle holder, insert the needle into the needle receiving hole, and place the needle holder above the needle holder platform.

[0041] Using step three, operate the press to apply pressure for assembly. The upper chuck drives the syringe body to move downwards along the guide rod, pressing against the needle seat.

[0042] The connecting end at the bottom of the syringe barrel is pressed downwards against the needle seat; the guide seat moves precisely along the guide rod, accurately positioning the connecting end of the syringe barrel towards the needle seat via the guide hole, ensuring accurate positioning during the pressing process and improving the pressing accuracy. During this process, the needle seat platform is inserted into the needle seat insertion guide hole.

[0043] Using step four, the press is reset. The upper clamp drives the syringe holder body to move upward along the guide rod to reset. At this time, the needle holder is successfully inserted into the connecting end, and the needle is driven to leave the needle holder along with the syringe barrel; while the guide seat remains at the needle holder.

[0044] At this point, a pre-filled syringe with a needle is formed, i.e., a syringe. The syringe can be removed from the mounting groove of the syringe holder body, thus restoring the needle pressing fixture of the pre-filled syringe for ultra-high viscosity drugs of this invention to the ready state of step one, and step one can be repeated to place new needle assemblies to be assembled in the pre-filled syringe.

[0045] This invention relates to a needle pressing fixture for a pre-filled syringe for ultra-high viscosity drugs. Designed based on the structural characteristics of the pre-filled syringe for ultra-high viscosity drugs, it enables efficient and reliable assembly of the needle assembly at the end of the syringe barrel. The pressure is adjusted by using a pressure spring, ensuring a safe and reliable pressing process. Attached Figure Description

[0046] Figure 1This is a schematic diagram of the external structure of a pre-filled syringe for ultra-high viscosity drugs.

[0047] Figure 2 A schematic diagram of the internal structure of a pre-filled syringe for ultra-high viscosity drugs;

[0048] Figure 3 for Figure 2 A magnified view of a portion of the image;

[0049] In the diagram: 1-syringe; 10-medicine; 11-syringe barrel; 12-flange; 13-connecting end; 14-piston; 15-push rod; 16-needle hub; 17-needle;

[0050] Figure 4 This is a schematic diagram of the overall structure of the needle pressing tooling for the pre-filled syringe for ultra-high viscosity drugs of this utility model.

[0051] Figure 5 This is a schematic diagram of the overall structure of a manual press.

[0052] In the diagram: 2-press; 21-base; 211-mounting slot; 22-column;

[0053] 23-Working head; 24-Upper chuck; 242-Fixing screw hole; 25-Operating handle; 252-Ball head;

[0054] Figure 6 This is a schematic diagram of the overall structure of the needle pressing fixture of this utility model;

[0055] Figure 7 This is a schematic diagram of the needle holder and guide seat before assembly;

[0056] Figure 8 This is a cross-sectional view of the needle holder;

[0057] Figure 9 This is a schematic diagram of the assembly structure of the needle holder and guide seat;

[0058] Figure 10 A sectional view of the needle holder and guide seat after assembly;

[0059] Figure 11 This is a partially enlarged schematic diagram of the internal structure of the guide seat;

[0060] Figure 12 This is a schematic diagram of the overall assembly structure of the syringe holder;

[0061] Figure 13 This is a general sectional view of the syringe holder.

[0062] Figure 14 This is a schematic diagram of the syringe housing components before assembly.

[0063] Figure 15 A schematic diagram of the components of the upper structure of the syringe holder before assembly;

[0064] Figure 16 This is an overall sectional view of the syringe holder;

[0065] Figure 17 This is a schematic diagram of the overall structure of step one of the use of this utility model;

[0066] Figure 18 for Figure 17 A magnified view of a portion of the image;

[0067] Figure 19 This is a schematic diagram of the overall structure of step two in the use of this utility model;

[0068] Figure 20 for Figure 19 A magnified view of a portion of the image;

[0069] Figure 21 This is a partially enlarged schematic diagram of step three in the use of this utility model;

[0070] Figure 22 This is an overall sectional view of the needle pressing fixture in step three of the use of this utility model;

[0071] Figure 23 for Figure 22 Enlarged view of a part Figure 1 ;

[0072] Figure 24 for Figure 22 Enlarged view of a part Figure 2 ;

[0073] Figure 25 This is a schematic diagram of the overall structure of step four in the use of this utility model;

[0074] Figure 26 This is an overall sectional view of the needle pressing fixture in step four of the use of this utility model;

[0075] Figure 27 for Figure 26 Enlarged view of a part Figure 1 ;

[0076] Figure 28 for Figure 26 Enlarged view of a part Figure 2 ;

[0077] Figure 29 This is a schematic diagram of the overall structure of step five in the use of this utility model;

[0078] Figure 30 for Figure 29 A magnified view of a portion of the image. Detailed Implementation

[0079] The specific embodiments of this utility model will be further described in detail below with reference to the accompanying drawings.

[0080] The purpose of this invention is to provide a needle filling tooling for a pre-filled syringe for ultra-high viscosity drugs, aiming to... Figures 1-3 The needle assembly (needle hub 16 and needle 17) shown is smoothly assembled into the cavity of the connecting end 13 at the bottom of the syringe barrel 11, thereby forming a pre-filled syringe for ultra-high viscosity drugs.

[0081] This utility model discloses a needle pressing tooling for a pre-filled syringe for ultra-high viscosity drugs. The overall structure can be referred to as follows: Figure 4 The needle pressing fixture needs to be installed entirely inside a press. The fixture used in this implementation is as follows: Figure 5 The manual press 2 shown can adjust the height of the working head 23 along the column 22, thereby adjusting the distance between the upper chuck 24 and the base 21 to adapt to the overall height of the needle pressing fixture of this utility model. The base 21 is generally provided with a mounting groove 211 or mounting hole for fixed connection with the bottom of the needle pressing fixture. The upper chuck 24 is generally provided with a mounting hole, and the top of the needle pressing fixture is connected by screwing a fixing screw into the fixing screw hole 242. By rotating the operating handle 25, the upper chuck 24 can be extended downward to press down. The end of the operating handle 25 is generally provided with a ball head 252 for easy gripping by the operator.

[0082] If necessary, an electric / automatic press can also be used, as long as the base mounting interface and top mounting interface can be adapted according to the structure of the press.

[0083] The key feature of this invention is to provide a needle pressing fixture, the overall structure of which is as follows: Figure 6 As shown, it includes a needle holder 3, a guide rod 4, and a syringe holder body composed of a guide seat 5, a sliding seat 6, a connecting seat 7, and a pressure seat 8; wherein, the bottom of the needle holder 3 is provided with an installation interface for connecting to the base 21, and the top of the connecting seat 7 is also provided with an installation handle 9 for connecting to the upper clamp 24.

[0084] The needle pressing fixture of this utility model has two stations to improve pressing efficiency, which can simultaneously press needle assemblies onto two syringes.

[0085] The specific structure of the needle holder 3 of the needle pressing tool of this utility model is as follows: Figures 7-10 As shown; the main body of the needle holder 3 is a square block, namely the needle holder body 31; the bottom of the needle holder body 31 is provided with a holder fixing head 32. In this embodiment, the holder fixing head 32 adopts a cylindrical design, and... Figure 5The structure of the mounting groove 211 on the base 21 of the manual press 2 shown is different. When the base fixing head 32 is cylindrical, it is adapted to a base with mounting holes. When the base is a mounting groove, the base fixing head 32 with a T-shaped mounting head is used. The specific adaptation can be made according to the mounting interface of the press base.

[0086] A guide rod 4 is fixedly mounted upward on the needle holder 31, preferably with two circular guide rods 4; in this embodiment, guide rod mounting holes 33 are provided on both sides of the needle holder 31, and a limiting platform 34 is provided in the guide rod mounting holes 33; a screw hole 35 is provided at the bottom of the guide rod mounting hole 33, and a stepped through hole 352 is formed between the guide rod mounting hole 33 and the screw hole 35; correspondingly, the guide rod 4 has a cylindrical guide rod body 41, and a limiting surface 43 is provided at the bottom, so that the bottom of the guide rod body 41 can be The guide rod 41 is inserted into the guide rod mounting hole 33, and the limiting surface 43 is adapted to the limiting platform 34, so that the direction of the guide rod 41 is fixed relative to the needle seat 31. The bottom of the guide rod 41 is provided with a mounting screw hole, and the mounting screw 36 is inserted into the screw hole 35 of the needle seat 31. The screw hole 35 is a countersunk hole that can accommodate the screw head of the mounting screw 36, while the screw part further passes through the stepped through hole 352 and is screwed into the mounting screw hole at the bottom of the guide rod 41, thus realizing the fixed installation of the guide rod 4 on the needle seat 3.

[0087] The needle holder body 31 of the needle holder 3 preferably protrudes upward to form a needle holder platform 37. The needle holder platform 37 is provided with a guide hole 38, and the guide hole 38 extends downward to form a needle receiving hole 39.

[0088] Two vertical guide rods 4 are fixed on both sides of the needle holder 3. The guide rod body 41 of the guide rod 4 is preferably cylindrical. A guide seat 5 that can slide up and down is sleeved on the guide rod 4. The guide rod body 41 of the guide rod 4 has a lower locking slot 44 and an upper locking slot 45 respectively at both ends that slide up and down along the guide seat 5.

[0089] The structure of guide seat 5 can be further referred to Figure 11The guide seat 5 has a relatively flat guide body 51, and guide holes 52 are provided on both sides of the guide body 51. The guide holes 52 are sleeved on the guide rod body 41 to realize sliding guidance. The side of the guide body 51 has a positioning hole 53 opposite to the guide hole 52, and a positioner 54 is installed in it. In this embodiment, the positioner 54 is a standard ball screw, which has a threaded housing 541 and a steel ball 542 that can protrude or be hidden. A spring 543 is provided behind the steel ball 542. The positioning hole 53 is a threaded hole. The positioner 54 of the ball screw is screwed into the positioning hole 53, so that the steel ball 542 at the end protrudes from the guide. When the guide hole 52 is located in the cylindrical section of the guide rod 41, the guide rod 41 applies force to push the steel ball 542 into the threaded housing 541. When the guide hole 52 moves to the lower latch 44 or upper latch 45 of the guide rod 41, the steel ball 542, under the action of the spring 543, will protrude from the threaded housing 541 and be inserted into the recess of the lower latch 44 or upper latch 45. This causes the guide seat 5 to be temporarily held in the lower latch 44 or upper latch 45 of the guide rod 41. A certain force needs to be applied to push the steel ball 542 back into the threaded housing 541, so that the guide seat 5 can resume free sliding up and down.

[0090] In this embodiment, the lower latch 44 or the upper latch 45 is a single-phase recess, or it can be a concave ring around the guide rod 41. When a concave ring is used, the guide rod 4 does not need to be positioned and installed with the needle holder 3 (no need to set the limiting platform 34 and the limiting surface 43).

[0091] The guide seat 5 has two through guide holes 55.

[0092] The guide seat 5, sliding seat 6, connecting seat 7, and pressure seat 8 constitute a syringe holder, used to accommodate a syringe pre-filled with ultra-high viscosity drugs (including a syringe barrel 11 containing the drug 10, and then fitted with a piston 14 and a push rod 15). Figure 12 , Figure 13 As shown; the sliding seat 6 is connected to the connecting seat 7, and the pressure seat 8 is installed inside the connecting seat 7. The three can move up and down along the guide rod 4.

[0093] Sliding seat 6, further reference Figure 14The sliding seat 61 has a hollowed-out middle section forming a cavity 616. The lower sides of the sliding seat 61 have sliding holes 62, which are fitted onto the upper part of the guide rod 4. The upper sides of the sliding seat 61 have connecting screw holes 63. The lower part of the sliding seat 61 has two cylinder mounting slots 64, and the upper part of the sliding seat 61 also has two mounting slots, but larger in size, consisting of a connecting mounting slot 65 and a flange mounting slot 66. The upper part of the sliding seat 61 also has an adjusting screw hole 67, in which an adjusting screw 68 is installed. The adjusting screw 68 is screwed into the adjusting screw hole 67 from bottom to top. The head of the adjusting screw 68 is located within the cavity 616, while the top of the adjusting screw 68 can extend beyond the sliding seat 6, forming a limiting protrusion 688.

[0094] Connector 7, see further reference Figure 15 The connecting seat 71 has a "door"-shaped design. Both sides of the connecting seat 71 have screw holes 72, which are countersunk holes at the top, allowing the mounting screws 73 to be fully inserted. More preferably, the bottom of the screw holes 72 has a stepped countersunk hole 722. Correspondingly, the top of the connecting screw hole 63 of the sliding seat 61 protrudes upwards to form a positioning step 633, which matches the stepped countersunk hole 722. When the connecting seat 7 and the sliding seat 6 are installed together, further reference is made to... Figure 16 The positioning step 633 is inserted into the countersunk hole 722, so that the screw hole 72 and the connecting screw hole 63 are connected. The mounting screw 73 is inserted into the screw hole 72, and the stud passes through the screw hole 72 and is screwed into the connecting screw hole 63, thereby fixing the connecting seat 7 and the sliding seat 6.

[0095] The pressure seat 8 is slidably installed in the cavity of the connecting seat 7. The pressure seat 8 can move up and down along the connecting seat 7, and a linear guide is provided between the two. That is, guide blocks 74 are provided on both sides of the cavity of the connecting seat 7, and guide grooves 82 are provided on both sides of the pressure seat 8. The guide grooves 82 match the guide blocks 74.

[0096] The lower side of the top of the connecting seat 7 is provided with an adjusting screw hole 75, and the upper side is provided with a mounting screw hole 78; preferably, the adjusting screw hole 75 and the mounting screw hole 78 are interconnected, and their threads are the same and connected. An adjusting screw 76 is installed in the adjusting screw hole 75, and a mounting handle 9 is installed in the mounting screw hole 78. The mounting handle 9 has a connecting post 91 and a mounting stud 92. The connecting post 91 is connected to the upper chuck 24, and the mounting stud 92 is screwed into the mounting screw hole 78 and connected to the connecting seat 7.

[0097] The top of the connector 7 is also provided with two push rod mounting slots 79.

[0098] The pressure seat 8 has a pressure seat body 81, and guide grooves 82 are formed on both sides of the pressure seat body 81; two push rod mounting grooves 83 are provided on the inner side of the pressure seat body 81, and a pressure surface 84 is formed on the lower side of the push rod mounting grooves 83; a spring hole 85 is provided in the middle of the upper part of the pressure seat body 81. The spring hole 85 is a blind hole, and a pressure spring 77 is installed in it.

[0099] like Figure 16 As shown, a pressure spring 77 is installed in the spring hole 85 of the pressure seat 8, and an adjusting screw 76 is screwed into the top of the connecting seat 7. Then, the guide grooves 82 on both sides of the pressure seat 8 are aligned with the guide blocks 74 of the connecting seat 7 to achieve pre-installation. Then, a sliding seat 6 is installed below the connecting seat 7, and the sliding seat 6 is fixed to the connecting seat 7 by the mounting screw 73. At this time, the pressure seat 8 is confined within the connecting seat 7. An adjusting screw 68 is screwed into the adjusting screw hole 67 at the top of the sliding seat 6, so that the top of the adjusting screw 68 exceeds the limiting protrusion 688 formed by the sliding seat 6 and abuts against the bottom of the pressure seat 8. By adjusting the protrusion height of the adjusting screw 68, the distance between the pressure surface 84 at the bottom of the pressure seat 8 and the bottom surface of the sliding seat 6 can be adjusted. The upper part of the pressure seat is subjected to the action of the pressure spring 77. By adjusting the adjusting screw 76, the pre-compression length of the pressure spring 77 can be adjusted, thereby adjusting the elastic force applied by the pressure spring 77 to the pressure seat 8. A clearance cavity 88 is formed between the top of the pressure seat 8 and the top of the connecting seat 7, and the spacing of this part is adjusted by the extension length of the adjusting screw 76.

[0100] Further as Figure 13 As shown, the syringe holder body, composed of guide seat 5, sliding seat 6, connecting seat 7, and pressure seat 8, has, from top to bottom, a push rod mounting slot 79, a push rod mounting slot 83, a flange mounting slot 66, a connecting mounting slot 65, and a barrel mounting slot 64, forming an open syringe mounting slot. There are two such slots, aligned with the two guide holes 55 on the guide seat 5, and further as shown... Figure 6 As shown, it is aligned with the two needle bases 37 on the needle base 3 (and the internal guide hole 38, and the lower needle receiving hole 39).

[0101] After the needle pressing fixture of this utility model is installed into the manual press 2, it forms the needle pressing fixture for the pre-filled syringe for ultra-high viscosity drugs of this utility model. The usage process is as follows: Figures 17-30 As shown.

[0102] Use step one, such as Figure 17 , Figure 18As shown, a pre-filled syringe is placed, and the syringe barrel 11 is inserted into the barrel placement groove 64, while the flange 12 of the syringe barrel 11 is inserted into the flange placement groove 66. The flange 12 generally has a reinforcing rib below it, which is then inserted into the connection placement groove 65. The part of the push rod 15 that extends beyond the syringe barrel 11 is inserted into the push rod placement groove 83, and the top of the push rod 15 is inserted into the push rod top placement groove 79. At this time, the bottom connecting end 13 of the syringe barrel 11 is exposed downward at the bottom of the sliding seat 6. At this time, the guide seat 5 rests on the needle seat 3.

[0103] Use step two, such as Figure 19 , Figure 20 As shown, manually push the guide seat 5 upwards until it engages with the upper latch 45; this causes the guide hole 55 of the guide seat 5 to cover the connecting end 13; see further details. Figure 23 The guide hole 55 is a multi-stage stepped hole, with a guide cone hole 551 at the top and a guide limiting hole 552 in the middle. Through the guide cone hole 551, when the guide seat 5 is pushed upward, it can quickly align with the bottom of the connecting end 13 of the syringe barrel 11, so that the connecting end 13 can be smoothly inserted into the guide limiting hole 552. The lower part of the guide hole 55 is also provided with a needle seat insertion guide hole 553, which is in communication with the guide limiting hole 552, and the diameter of the needle seat insertion guide hole 553 matches the diameter of the opening hole of the connecting end 13. Preferably, the bottom of the needle seat insertion guide hole 553 is also provided with an arc-shaped guide 554 to facilitate the connection with the needle seat 16.

[0104] At this time, the ball 542 of the ball screw of the positioner 54 of the guide seat 5 is precisely inserted into the recess of the upper slot 45, thereby keeping the guide seat 5 in the upper part and exposing the upper surface of the needle seat 3 below.

[0105] Use step three, such as Figure 21 , Figure 22 , Figure 24 As shown, needle assemblies are placed in the two needle bases 37 of the needle base 3, so that the needle 17 is inserted into the needle receiving hole 39, and the needle base 16 is located above the needle base 37.

[0106] Use step three, such as Figure 25 , Figure 26 , Figure 27 , Figure 28 As shown, the press is operated to apply pressure for assembly. In this embodiment, the operating handle 25 is pressed down, so that the upper clamp 24 drives the syringe seat body to move downward along the guide rod 4 and press against the needle seat 3.

[0107] The connecting end 13 is pressed downwards against the needle seat 16 by a force, and the force application process is as follows: Figure 17As shown, the press applies downward pressure to the connecting seat 7①, the connecting seat 7 applies downward pressure through the adjusting screw 76②, the pressure spring 77 is compressed and generates pressure③, the pressure spring 77 applies pressure to the pressure seat 8④, the pressure surface 84 of the pressure seat 8 applies pressure to the upper surface of the flange 12 at the top of the syringe barrel 11⑤, thereby causing the syringe barrel 11 to generate downward pressure⑥. This pressure allows the connecting end 13 at the bottom of the syringe barrel 11 to be press-fitted with the needle seat 16. By setting the pressure spring 77 and the pressure seat 8, the pressure applied to the syringe barrel 11 is the elastic force of the pre-adjusted pressure spring 77, thereby avoiding excessive pressure generated by the syringe seat body during the operation of the press from directly acting on the syringe barrel 11, causing excessive pressure between the connecting end 13 and the needle seat 16, and resulting in damage.

[0108] During this process, the needle seat 37 is inserted into the needle seat insertion guide hole 553. Therefore, it is necessary to adjust the protrusion height of the adjusting screw 68 according to the length of the syringe barrel 11, thereby adjusting the distance between the pressure surface 84 and the bottom surface of the sliding seat 6, and thus adjusting the distance between the pressure surface 84 and the needle seat 37, so as to avoid hard contact between the connecting end 13 of the syringe barrel 11 and the needle seat 37, which would lead to damage to the syringe barrel 11.

[0109] During this process, the guide seat 5 moves precisely along the guide rod 4 and precisely positions the connecting end 13 of the syringe barrel 11 through the guide hole 55 to move towards the needle seat 16 on the needle seat 3, so that the positioning of the pressing process is accurate and the pressing accuracy is improved.

[0110] Use step four, such as Figure 29 , Figure 30 As shown, the press resets, and the upper chuck 24 drives the syringe holder body to move upward along the guide rod 4 to reset. At this time, the needle holder 16 is smoothly inserted into the connecting end 13, driving the needle 17 to leave the needle holder 3 along with the syringe barrel 11; and the ball bearing 542 of the ball screw of the guide seat 5's positioner 54 also fits into the recess of the lower jaw 44, leaving the guide seat 5 at the needle holder 3. The gravity of the guide seat 5 itself also keeps it in place.

[0111] At this point, a pre-filled syringe with a needle tip, namely syringe 1, is formed. Syringe 1 can be removed from the mounting groove of the syringe holder body, thereby restoring the needle pressing tool of the pre-filled syringe for ultra-high viscosity drugs of this invention to the ready state of step one, and step one can be repeated to place new needle tip assemblies into the pre-filled syringe.

[0112] The preferred embodiments of this utility model have been described in detail above, but this utility model is not limited to the embodiments described. Those skilled in the art can make various equivalent modifications or substitutions without departing from the spirit of this utility model, and these equivalent modifications or substitutions are all included within the scope defined by the claims of this application.

Claims

1. A needle-filling tooling for a pre-filled syringe for ultra-high viscosity drugs, characterized in that, Includes a press, with a needle pressing fixture provided between the base and the upper press head of the press; The needle pressing fixture includes a needle seat, a guide rod, and a syringe seat consisting of a guide seat, a sliding seat, a connecting seat, and a pressure seat; The needle holder is fixed to the base of the press, and a guide rod is fixed on the needle holder. The guide seat is sleeved on the guide rod and can move up and down along the guide rod. The sliding seat is connected to the connecting seat, and the bottom of the sliding seat is sleeved on the upper part of the guide rod. The connecting seat is connected to the upper pressure head of the press. The pressure application seat is installed in the connecting seat. The needle holder has a needle-accepting hole; The guide seat is located above the needle holder. The guide seat has a guide hole and slides with the guide rod. The guide seat has a guide hole that runs through the needle from top to bottom. The lower sides of the sliding seat have sliding holes, which are fitted onto the upper part of the guide rod and slide in cooperation with the guide rod; the lower part of the sliding seat has a cylinder mounting groove; the upper part of the sliding seat has a flange mounting groove. The connecting seat is fixed above the sliding seat, and the interior of the connecting seat forms a cavity with a pressure seat. The height of the pressure seat is less than the height of the cavity inside the connecting seat, and the pressure seat is slidably installed in the cavity of the connecting seat. The lower side of the top of the connector is provided with an adjusting screw hole, and an adjusting screw is installed in the adjusting screw hole; The top of the connector is provided with a push rod mounting slot; The inner side of the pressure seat is provided with a push rod mounting groove, and the lower side of the push rod mounting groove forms a pressure surface; The upper part of the pressure seat is provided with a spring hole, which is a blind hole, and a pressure spring is installed in the spring hole; the top of the pressure spring abuts against the bottom of the adjusting screw; The syringe holder body, consisting of a guide seat, a sliding seat, a connecting seat, and a pressure seat, forms an open syringe holder from top to bottom, consisting of a push rod top placement groove, a push rod placement groove, a flange placement groove, and a barrel placement groove. This groove is aligned with the guide hole on the guide seat and the needle receiving hole on the needle holder.

2. The needle pressing tooling for the pre-filled syringe for ultra-high viscosity drugs as described in claim 1, characterized in that, The syringe mounting slot is provided in two or more sets, and the needle holder is provided in two or more needle receiving holes; the syringe mounting slot and the needle receiving hole correspond one-to-one.

3. The needle pressing tooling for a pre-filled syringe for ultra-high viscosity drugs as described in claim 1, characterized in that, The upper surface of the needle holder protrudes upward to form a needle holder platform, and a guide hole is provided inside the needle holder platform. The guide hole extends downward to form a needle receiving hole.

4. The needle pressing tooling for a pre-filled syringe for ultra-high viscosity drugs as described in claim 3, characterized in that, The guide hole of the guide seat is a multi-stage stepped hole, with a guide cone hole at the top and a guide limiting hole in the middle; The lower part of the guide hole is provided with a needle seat that inserts into the guide hole, and the needle seat is connected to the guide limiting hole; The inner diameter of the needle holder insertion guide hole is larger than the outer diameter of the needle holder platform, and the needle holder platform can be inserted into the needle holder insertion guide hole.

5. The needle pressing tooling for a pre-filled syringe for ultra-high viscosity drugs as described in claim 1, characterized in that, Two vertical guide rods are fixed on both sides of the needle holder. The guide rod body is cylindrical. The guide rod body has a lower locking slot and an upper locking slot at both ends that slide up and down along the guide seat. The side of the guide seat has a positioning hole opposite to the guide hole, and a positioner is installed inside it; the positioning end of the positioner matches the lower and upper bayonets.

6. The needle pressing tooling for a pre-filled syringe for ultra-high viscosity drugs as described in claim 5, characterized in that, The positioning hole is a threaded hole that runs through both the inside and outside; The positioner is a ball screw with a threaded housing that is screwed into a threaded hole. The threaded housing is fitted with a protruding or concealable steel ball, and a spring is provided behind the steel ball; The ball bearing protrudes from the guide hole wall, and when the ball bearing is hidden, it is completely concealed within the hole wall.

7. The needle pressing tooling for a pre-filled syringe for ultra-high viscosity drugs as described in claim 1, characterized in that, The middle of the sliding seat is hollowed out, forming a cavity.

8. The needle pressing tooling for a pre-filled syringe for ultra-high viscosity drugs as described in claim 7, characterized in that, The upper part of the sliding seat is provided with an adjusting screw hole, and an adjusting screw is installed in the adjusting screw hole. The adjusting screw is screwed into the adjusting screw hole from bottom to top. The top of the adjusting screw extends beyond the sliding seat, forming a limiting protrusion that abuts against the bottom surface of the pressure seat.

9. The needle pressing tooling for a pre-filled syringe for ultra-high viscosity drugs as described in claim 1, characterized in that, The connector has screw holes on both sides, and mounting screws are installed in the screw holes; The upper two sides of the sliding seat are provided with connecting screw holes; Screw the mounting screws into the connecting screw holes to securely connect the sliding seat and the connecting seat.

10. The needle pressing tooling for a pre-filled syringe for ultra-high viscosity drugs as described in claim 1, characterized in that, Guide blocks are provided on both sides of the cavity of the connector; The pressure seat has guide grooves on both sides, which match the guide blocks to form a straight guide.

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