Pre-filled syringe suitable for complex formulation applications
By designing a cylindrical syringe with open ends, the problem of incomplete filling and injection of viscous drugs was solved, achieving complete filling and injection of the drug, ensuring full utilization of the drug and ease of operation.
Patent Information
- Application Number
- CN202423150948.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-19
- Publication Date
- 2026-03-13
- Estimated Expiration
- 2034-12-19
AI Technical Summary
Existing pre-filled syringes have problems with incomplete filling and injection when handling highly viscous drugs, especially drug accumulation at the needle tip, which affects the treatment effect.
A cylindrical syringe with open ends was designed. The special structure of the piston and needle seat achieves a sealed and reliable connection of the drug, ensuring that the drug does not come into contact with air during the sealed filling and injection process in the syringe.
It achieves complete filling and injection of the drug, reduces drug residue, ensures full utilization of the drug, and is simple and convenient to operate.
Smart Images
Figure CN223988040U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to a disposable pre-filled syringe suitable for complex formulation applications, belonging to the field of medical injection devices. Background Technology
[0002] Currently, commercially available syringes, especially prefilled syringes (PFS), are of standard size and have a relatively fixed structure. The bottom of the syringe barrel tapers to form a needle hub for attaching the needle. In the biopharmaceutical field, some pharmaceutical products have high viscosity. When using standard-sized syringes for drug filling, if a fine-diameter syringe is used, the long, thin syringe barrel is not conducive to drug filling (because the drug has high viscosity and poor flowability, a long, thin filling head is required when filling from the top, and this long, thin filling head is difficult to maintain). If a regular-diameter syringe is used, the difference between the inner diameter of the syringe barrel and the diameter of the needle is large, which is not conducive to the final drug injection, especially at the needle tip, where the drug accumulates in the dead corner of the syringe barrel, resulting in incomplete drug injection and affecting the therapeutic effect.
[0003] Therefore, for complex formulations such as drugs with high viscosity, the structure of the pre-filled syringe needs to be specially designed to take into account both the pre-filling requirements of the drug and the requirements for injection. Utility Model Content
[0004] The purpose of this invention is to provide a pre-filled syringe suitable for complex formulation applications. It improves the structure of the barrel and sets up a cylindrical drug chamber with openings at both ends, allowing the drug to be filled from the needle tip. The drug pushes the piston to achieve real-time sealing, making it particularly suitable for complex formulation applications. After the drug is filled, the needle hub and needle tip seal the barrel, creating a reliable seal.
[0005] To achieve the above-mentioned utility model objectives, this utility model provides a pre-filled syringe suitable for complex formulation applications, including a barrel, a piston, a needle hub, and a needle; the piston is located inside the barrel, the needle is assembled on the needle hub, and the needle hub is assembled and fixed to the barrel after the drug is filled.
[0006] A tube, having a cylindrical body, with the interior of the body being a cylindrical medicine container open at both ends;
[0007] The lower part of the cylinder has an installation cylinder;
[0008] The piston has a plug body with a sealing ring on it; in the free state, the diameter of the sealing ring is larger than the inner diameter of the medicine chamber, and the sealing ring is tightly attached to the medicine chamber.
[0009] The needle hub has a seat sleeve, which is connected and fixed together with the mounting sleeve of the tube.
[0010] The inner bottom surface of the needle seat matches the bottom surface of the piston body. When the piston contacts the needle seat, the inner bottom surface of the needle seat completely fits the bottom surface of the piston body.
[0011] The needle is connected to the middle of the needle hub.
[0012] As a further improvement of this utility model, the mounting cylinder of the tube is located outside the tube body, and the inner wall of the mounting cylinder of the tube has a needle seat joint.
[0013] The inner side of the needle seat is a receiving cavity, which matches the lower part of the tube;
[0014] The wall of the seat tube is provided with a fixing part that matches the needle seat joint.
[0015] As a further improvement of this utility model, the bottom inner side of the needle seat is provided with a sealing plane, which contacts and seals with the bottom plane of the tube body.
[0016] The bottom of the piston body is a push-push plane, which is a plane and perpendicular to the axis of the piston and the drug chamber.
[0017] Furthermore, the needle has a syringe tube, the top of which extends upward and is flush with the sealing surface.
[0018] As a further improvement of this utility model, a push rod is provided; the piston is combined with the end of the push rod.
[0019] As a further improvement of this utility model, a soft protective cap is provided, which has a soft cap body and a needle cavity sealed at one end inside the soft cap body; the top of the soft cap body has a sealing surface.
[0020] The soft protective cap is fitted onto the bottom of the needle hub, and the sealing surface covers the bottom of the needle hub;
[0021] The soft cap houses the needle within the needle cavity.
[0022] Furthermore, the bottom of the needle hub is provided with a protective cap connecting protrusion, which supports the top of the soft protective cap from the inside.
[0023] Furthermore, it is equipped with a hard cap, which has a hard cap body and a soft cap cavity inside the hard cap body;
[0024] The hard cap is placed over the soft cap, and the soft cap is contained inside the soft cap cavity.
[0025] Furthermore, the top of the soft cap protrudes outward to form a snap-fit ring;
[0026] The top inner side of the hard cap body is provided with a snap-fit groove;
[0027] The snap-fit groove and snap-fit ring are combined.
[0028] As a further improvement of this utility model, the upper part of the cylinder body has reinforcing ribs, and the top of the cylinder body has a flange.
[0029] This utility model discloses a pre-filled syringe suitable for complex formulation applications. The manufacturer produces each component separately: the barrel, piston, plunger, needle hub, needle, soft cap, and hard cap. The needle and needle hub are reliably connected to form a needle hub assembly. The piston and plunger are combined to form a piston-push-rod assembly. Then, the piston and plunger are inserted into the barrel to form a barrel assembly. Finally, the needle hub assembly is combined with the soft and hard caps to form a needle hub assembly, which is then delivered to the drug manufacturer.
[0030] After receiving the syringe and needle hub assemblies, the pharmaceutical manufacturer first takes the syringe assembly and fills it with the medication. The piston is pushed to the bottom of the syringe, and then the syringe is installed on the medication filling equipment, ensuring a tight seal between the bottom of the syringe and the medication outlet, with the piston also close to the outlet, leaving virtually no air between them. The medication is then injected from the bottom of the syringe. Once inside the cartridge, the medication pushes the piston and push rod upwards, maintaining a sealed environment within the cartridge and preventing air from being generated. This process continues until the cartridge is fully filled. Next, the needle hub assembly is taken and inserted into the bottom of the syringe to seal the cartridge. At this point, the pre-filled syringe of this invention, suitable for complex formulations, is fully filled with medication and can be combined with other components or used directly for storage and transportation.
[0031] This invention relates to a pre-filled syringe suitable for complex formulation applications. The syringe is filled with medication from the needle tip and then assembled with the needle hub assembly to establish a sterile barrier. A special connection structure is used between the needle hub and the syringe barrel to fully ensure sealing and connection reliability.
[0032] This invention relates to a pre-filled syringe suitable for complex formulation applications. Upon reaching the point of use, the hard cap and soft cap are removed to expose the needle. After inserting the needle into the injection site, the plunger is pushed to inject the medication directly from the cartridge into the needle. After the medication is injected, the piston rests against the end of the cartridge, tightly against the sealing surface of the needle hub, ensuring that the medication is completely pushed into the needle. This minimizes residual dosage, eliminates any dead zones of medication residue within the syringe, and ensures full utilization of the medication.
[0033] This invention relates to a pre-filled syringe suitable for complex formulation applications. Through structural modifications, the syringe facilitates drug filling without requiring a long, thin filling tube and without contact with air during the filling process. After filling, the syringe is sealed using the needle hub. The entire process of filling and injecting the drug is virtually identical to existing syringes, making operation simple and convenient. Attached Figure Description
[0034] Figure 1 This is a schematic diagram of the overall structure of the pre-filled syringe of this utility model, suitable for complex formulation applications.
[0035] Figure 2 Exploded view of the components of the pre-filled syringe suitable for complex formulation applications according to this utility model;
[0036] Figure 3 This is a schematic diagram of the overall structure of the tube of this utility model;
[0037] Figure 4 This is a schematic diagram of the internal structure of the tube of this utility model;
[0038] Figure 5 for Figure 4 A magnified view of a portion of the image;
[0039] Figure 6 This is a schematic diagram of the overall structure of the piston of this utility model. Figure 1 ;
[0040] Figure 7 This is a schematic diagram of the overall structure of the piston of this utility model. Figure 2 ;
[0041] Figure 8 This is a schematic diagram of the internal structure of the piston of this utility model;
[0042] Figure 9 This is a schematic diagram of the combined structure of the push rod and piston of this utility model;
[0043] Figure 10 This is a schematic diagram of the end structure of the push rod of this utility model;
[0044] Figure 11 This is a schematic diagram of the specific connection structure of the push rod and piston assembly of this utility model;
[0045] Figure 12 This is a schematic diagram of the overall structure of the needle holder and needle tip in the combined state of this utility model.
[0046] Figure 13 This is a schematic diagram of the internal structure of the needle holder and needle tip in the combined state of this utility model.
[0047] Figure 14 A schematic diagram showing the specific connection structure between the needle hub and the needle tip and the tube;
[0048] Figure 15 This is a schematic diagram of the overall structure of the soft protective cap of this utility model;
[0049] Figure 16 This is a schematic diagram of the internal structure of the soft protective cap of this utility model;
[0050] Figure 17 This is a schematic diagram of the overall structure of the hard protective cap of this utility model;
[0051] Figure 18 This is a schematic diagram of the internal structure of the hard protective cap of this utility model;
[0052] Figure 19 A schematic diagram showing the specific structure for installing soft and hard protective caps on the needle hub to shield the needle tip;
[0053] Figure 20 This is a schematic diagram showing the delivery status of components of the pre-filled syringe suitable for complex formulation applications according to this utility model.
[0054] Figure 21 This is a schematic diagram of the process of filling the tube assembly with the agent according to this utility model;
[0055] Figure 22 This is a schematic diagram of the tube assembly of this utility model after the filling of the agent is completed;
[0056] Figure 23 This is a schematic diagram of the assembly and sealing of the pre-filled syringe of the present invention, which is suitable for complex formulation applications, after the drug is filled, i.e., a schematic diagram of the drug delivery and storage status.
[0057] Figure 24 for Figure 23 A magnified view of a portion of the image;
[0058] Figure 25 A schematic diagram illustrating the ready-to-use state of the pre-filled syringe suitable for complex formulation applications according to this utility model.
[0059] Figure 26 This is a schematic diagram showing the injection completed state of the pre-filled syringe of this utility model, which is suitable for complex formulation applications.
[0060] Figure 27 for Figure 26 A magnified view of a portion of the image. Detailed Implementation
[0061] The specific embodiments of this utility model will be further described in detail below with reference to the accompanying drawings.
[0062] like Figure 1 The diagram shown is a schematic representation of the overall structure of the pre-filled syringe of this invention, suitable for complex formulation applications. Figure 2The diagram shown is an exploded view of the specific components. The pre-filled syringe of this invention, suitable for complex formulation applications, mainly includes the following components: barrel 1, piston 2, push rod 3, needle seat 4, needle 5, soft cap 6, and hard cap 7. Among them, piston 2 and push rod 3 are assembled together, and piston 2 is located inside barrel 1. The needle 5 is always assembled on needle seat 4. After the drug is filled, needle seat 4 is assembled and fixed to the bottom of barrel 1. Soft cap 6 is installed inside hard cap 7 and is removed together when the syringe is used to expose needle 5.
[0063] Spool 1, such as Figure 3 , Figure 4 , Figure 5 As shown, it has a cylindrical body 11, the interior of which is a cylindrical medicine container 12 with openings at both ends; the upper part of the cylindrical body 11 has a reinforcing rib 13, and the top of the cylindrical body 11 has a flange 14; the lower part of the cylindrical body 11 has a mounting cylinder 15, and the inner wall of the mounting cylinder 15 has a needle seat joint 16, specifically including a joint recess 161 and a joint protrusion 162.
[0064] Piston 2, such as Figure 6 , Figure 7 , Figure 8 As shown, it is generally made of rubber and has a plug body 21. The plug body 21 is provided with several sealing rings 22. In the free state, the diameter of the sealing rings 22 is slightly larger than the inner diameter of the medicine chamber 12. So when the piston 2 is inserted into the tube 1, the sealing rings 22 are compressed and tightly adhere to the medicine chamber 12. The plug body 21 has an installation hole 23 inside. The installation hole 23 is a blind hole and the lower part is a conical hole 24. The bottom of the plug body 21 is a push-push plane 25. The push-push plane 25 is a plane and is perpendicular to the axis of the piston 2 and the medicine chamber 12.
[0065] The piston 2 is reliably fixed to the end of the push rod 3 through the mounting hole 23 and the tapered hole 24. Figure 9 , Figure 11 As shown; the push rod 3 itself has a slender rod body 31, and further has several protruding ribs 32 along the rod body 31 to reinforce the rod body 31 and prevent bending deformation under force; one or both ends of the push rod 3 are provided with push heads 33, such as Figure 10 , Figure 11 As shown, the outer side of the pusher 33 is a cone 331, whose structure matches the cone hole 24. The inner side of the cone 331 is provided with a push neck 332, which matches the mounting hole 23. The innermost side of the pusher 33 is provided with a mounting limiting flange 333, whose diameter is larger than the push neck 332 but smaller than the inner diameter of the medicine chamber 12, which limits the piston 2 to be mounted on the push rod 3.
[0066] Needle hub 4, needle tip 5, such as Figure 12 , Figure 13As shown, the needle holder 4 has a seat 41, the inner side of which is a receiving cavity 42, and the bottom of the receiving cavity 42 is provided with a sealing plane 422; the wall of the seat 41 is provided with a fixing part 43 that matches the needle holder coupling part 16; the bottom of the seat 41 is provided with a limiting seat 44; the lower part of the needle holder 4 is tapered downwards, and a needle 5 is connected in the middle; the needle 5 has a needle tube 51, the top of the needle tube 51 extends upwards and is flush with the sealing plane 422, and the bottom of the needle tube 51 is provided with a sharp needle tip 52 for puncture. The bottom of the needle holder 4 is provided with a protective cap coupling protrusion 45.
[0067] like Figure 14 As shown, the needle holder 4 can be fixedly installed on the tube 1. The seat cylinder 41 is inserted into the mounting cylinder 15. The receiving cavity 42 of the seat cylinder 41 covers the lower part of the tube 11, and the sealing surface 422 abuts against the bottom surface of the tube 11. The needle holder connecting part 16 and the fixing part 43 are combined to form a positioning, limiting, and fixing mechanism, thereby reliably installing the needle holder 4 on the tube 1. The limiting seat 44 blocks the mounting cylinder 15 to prevent the mounting cylinder 15 from opening, thus preventing the needle holder 4 from falling off.
[0068] Soft protective cap 6, such as Figure 15 , Figure 16 As shown, it is generally made of elastic rubber and has a soft cap body 61. The soft cap body 61 contains a needle cavity 62 that is sealed at one end. The top of the soft cap body 61 has a sealing surface 63. The top of the soft cap body 61 protrudes outward to form a snap ring 64.
[0069] Hard protective cap 7, such as Figure 17 , Figure 18 As shown, it is generally made of hard plastic and has a hard cap body 71, inside which is a soft cap cavity 72; the bottom of the hard cap body 71 generally has an opening 73, so that the soft cap cavity 72 is connected to the outside. When the soft cap 6 is installed into the hard cap 7, the air in the soft cap cavity 72 can be discharged from the opening 73, preventing the air from compressing the soft cap 6 and causing it to deform, especially when in contact with the needle tip 52, making the soft cap 6 easy to be punctured by the needle tip 52; the top inner side of the hard cap body 71 has a snap-fit groove 74; the lower outer side of the hard cap body 71 has a cap-pulling protrusion 75.
[0070] like Figure 19As shown, the soft cap 6 and hard cap 7 are installed at the bottom of the needle holder 4 to seal and shield the needle 5. The soft cap 6 is fitted onto the needle holder 4, completely accommodating the needle 5 within the needle cavity 62. The sealing surface 63 of the soft cap 6 mates with the bottom of the needle holder 4 to form a seal. Simultaneously, the cap of the needle holder 4, combined with the protruding ring 45, supports the soft cap 6 from the inside, making the seal more reliable. The hard cap 7 is fitted over the soft cap 6, completely accommodating the soft cap within the soft cap cavity 72. Specifically, the upper part, through the engagement of the snap-fit groove 74 and the snap-fit ring 64, secures the soft cap 6 and hard cap 7 together. The hard cap 7 forms a rigid support on the outside of the soft cap 6, further preventing the soft cap 6 from being squeezed and deformed under external impact, thus ensuring the safety of the needle 5.
[0071] This utility model discloses a pre-filled syringe suitable for complex formulation applications. The manufacturer produces each component separately: barrel 1, piston 2, push rod 3, needle hub 4, needle 5, soft cap 6, and hard cap 7. The needle 5 and needle hub 4 are reliably connected together to form a needle hub assembly with a needle. The piston 2 and push rod 3 are combined to form a piston-push rod assembly. Then, the piston 2 and push rod 3 are inserted into the barrel 1 to form a barrel assembly. The needle hub assembly is then combined with the soft cap 6 and hard cap 7 to form a needle hub assembly, i.e., as shown... Figure 20 The two components shown are delivered to the drug manufacturer.
[0072] After receiving the tubing assembly and needle seat assembly, the pharmaceutical manufacturer first takes the tubing assembly and fills it with the pharmaceutical agent; then pushes the piston 2 to the bottom of the tubing 1, and then installs the tubing 1 onto the pharmaceutical filling equipment, so that the bottom surface of the cylinder 11 is aligned and sealed with the outlet. The pharmaceutical agent is then injected from the bottom of the cylinder 11. Figure 21 As shown, after the medicine enters the medicine chamber 12, it pushes the piston 2 and the push rod 3 upward. During the process, the medicine chamber 12 remains sealed and no air is generated; until... Figure 22 As shown, the medicine has been fully filled into the medicine chamber 12. Then, remove the needle hub assembly and insert the needle hub 4 into the bottom of the tube 1, using the needle hub 4 to seal the medicine chamber 12, as shown. Figure 23 , Figure 24 As shown. At this point, the pre-filled syringe of this invention, suitable for complex formulation applications, is fully loaded with medication and can be combined with other components or directly stored and transported.
[0073] This invention relates to a pre-filled syringe suitable for complex formulation applications. The syringe is filled with medication from the needle tip and then assembled with the needle hub assembly to establish a sterile barrier. The needle hub 4 and the barrel 1 use a special connection structure to fully ensure sealing and connection reliability.
[0074] This invention relates to a pre-filled syringe suitable for complex formulation applications. Upon reaching the usage end, it is ready for use, such as... Figure 25 As shown, remove the hard cap 7 along with the soft cap 6 to expose the needle 5. Insert the needle 5 into the injection site, and then inject by pushing the plunger 3. The medication enters the needle 5 directly from the medication cartridge 12. After the medication is injected, as shown... Figure 26 , Figure 27 As shown, the piston 2 abuts against the end of the drug chamber 12 and is pressed against the sealing plane 422 of the needle seat 4, thereby ensuring that the drug is completely pushed into the needle 5, minimizing the residual dosage, eliminating drug residue dead zones in the syringe, and ensuring full utilization of the drug.
[0075] 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 pre-filled syringe suitable for complex formulation applications, characterised in that, It comprises a barrel, a piston, a needle seat, and a needle; the piston is located in the barrel, the needle is assembled on the needle seat, and the needle seat is assembled and fixed to the barrel after the medicine is filled; The barrel has a barrel body, and the inside of the barrel body is a cylindrical medicine chamber with both ends open; The lower part of the barrel body has a mounting barrel; The piston has a plug body, and a sealing ring is arranged on the plug body; in a free state, the diameter of the sealing ring is greater than the inner diameter of the medicine chamber, and the sealing ring is tightly attached to the medicine chamber; The needle seat has a seat barrel, and the seat barrel is combined with the mounting barrel of the barrel to be connected and fixed; The inner side bottom surface of the seat barrel of the needle seat matches the bottom surface of the plug body of the piston, and when the piston contacts the needle seat, the inner side bottom surface of the seat barrel of the needle seat completely matches the bottom surface of the plug body of the piston; The needle seat is connected with the needle.
2. A pre-filled syringe suitable for complex formulation applications as claimed in claim 1, wherein, The mounting barrel of the barrel is located outside the barrel body, and the inner wall of the mounting barrel of the barrel has a needle seat combination part; The inner side of the seat barrel of the needle seat is a containing cavity, which matches the lower part of the barrel; The wall surface of the seat barrel is provided with a fixing part matched with the needle seat combination part.
3. The pre-filled syringe suitable for complex formulation application as claimed in claim 1, wherein, The inner side bottom of the seat barrel of the needle seat is provided with a sealing plane, which contacts and seals with the bottom plane of the barrel body of the barrel; The bottom of the plug body of the piston is a medicine pushing plane, which is a plane and is perpendicular to the axis of the piston and the medicine chamber.
4. A pre-filled syringe suitable for complex formulation applications as claimed in claim 3, wherein, The needle has a needle tube, and the top of the needle tube extends upward and is flush with the sealing plane.
5. The pre-filled syringe suitable for complex formulation applications as claimed in claim 1, wherein, A push rod is arranged; the piston is combined with the end of the push rod.
6. The pre-filled syringe suitable for complex formulation applications as claimed in claim 1, wherein, A soft cap is arranged, which has a soft cap body and a needle cavity with one end sealed in the soft cap body; The top of the soft cap body has a sealing surface; The soft cap is sleeved on the bottom of the needle seat, and the sealing surface wraps the bottom of the needle seat; The soft cap contains the needle in the needle cavity.
7. A pre-filled syringe suitable for complex formulation applications as claimed in claim 6, wherein, The bottom of the needle seat is provided with a cap combination convex ring which supports the top of the soft cap from the inside.
8. A pre-filled syringe suitable for complex formulation applications as claimed in claim 6, wherein, A hard cap is arranged, which has a hard cap body and a soft cap cavity in the hard cap body; The hard cap is sleeved outside the soft cap and contains the soft cap into the soft cap cavity.
9. A pre-filled syringe suitable for complex formulation applications as claimed in claim 8, wherein, The top of the soft cap body is outwardly protruding to form a clamping ring; The inner side of the top of the hard cap body is provided with a clamping groove; The clamping groove is combined with the clamping ring.
10. The pre-filled syringe suitable for complex formulation applications as claimed in claim 1, wherein, The upper part of the barrel body has a reinforcing rib, and the top of the barrel body has a flange.