Protective type pre-filled syringe
By setting up a convex member and a spacing step in the needle holder unit of the protective pre-filled syringe, the problem of accidental driving of the protective cover when the needle cover is pulled out is solved, and the safety and stability of the operation are improved.
Patent Information
- Application Number
- PCT/CN2024/108075
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-08-25
- Filing Date
- 2024-07-29
- Publication Date
- 2025-03-06
AI Technical Summary
The existing protective pre-filled syringe is prone to accidentally drive the protective cover when the needle cover is pulled out, causing the protective cover to fall out of the syringe barrel, posing a safety hazard.
By providing the ridge member and the spacer step in the needle seat unit, the needle sleeve is not completely close to the distal end surface of the ridge member when the needle sleeve is pulled, so that the protective cover unit will not be driven to move when the needle sleeve is pulled out.
It effectively avoids the phenomenon of accidentally driving the protective cover when pulling out the needle cover, improves the safety and stability of the operation, and reduces the risk of misoperation.
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Figure CN2024108075_06032025_PF_FP_ABST
Abstract
Description
A protective prefilled syringe Technical Field
[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a protective prefilled syringe. Background Art
[0002] Prefilled syringes are injection devices used in the medical field that integrate the functions of a syringe and a medication container. These syringes are pre-filled with medication during the manufacturing process and sealed to protect the drug's purity and effectiveness. This pre-filled design makes use more convenient and quicker for medical staff, reducing the time and steps required for medication preparation. Furthermore, because prefilled syringes are single-use, they avoid the risk of cross-infection and enhance patient safety. Furthermore, strict sealing measures are implemented during the manufacturing process to effectively protect the drug's purity and stability, extending its shelf life.
[0003] The main components of a prefilled syringe include the syringe body, medication container, piston, needle, and protective cap. The syringe body is typically made of transparent material, allowing medical personnel to clearly observe the dosage and status of the medication solution. The medication container is typically made of glass or plastic, with a capacity tailored to the needs, allowing for different dosages of medication. The piston pushes the medication into the needle for injection. The needle then delivers the medication into the patient. The protective cap protects the needle before and after use.
[0004] However, existing prefilled syringes are often discarded after use, leaving the needle exposed and dangerous. To address this issue, operators often replace the removed protective cap. However, this approach has many drawbacks. First, the protective cap is custom-made for the needle, with a small opening, making it difficult to reinsert after removal. Second, the reinstallation process can easily result in the needle pricking the operator's hand.
[0005] To solve the above problems, a protective prefilled syringe with a protective cover has been proposed on the market. The inventor has previously applied for an invention patent in the related field, specifically CN114642793A, a prefilled syringe with a front shield. The protective cover can adjust the axial position by pushing and pulling, which is used to expose the needle to complete the injection, and to cover the needle and discard it after the injection to avoid needle sticks to others.
[0006] However, during actual use of the aforementioned syringe, it was discovered, referring to the specification of the application, that during step S1 of using the pre-filled syringe, if the operator accidentally applied a force perpendicular to the axial direction to the shield while pushing the shield unit in the proximal axial direction, the shield could be directly separated from the syringe barrel. This is because when the force perpendicular to the axial direction is applied to the shield, the gap between the two adjacent stop hooks that hold the syringe barrel expands outward, resulting in an excessive gap between the two stop hooks, allowing the syringe barrel to pass directly through the two stop hooks, causing the shield to be separated from the syringe barrel.
[0007] Therefore, there is a need for a pre-filled syringe that can effectively prevent the protective cover from being accidentally driven when the needle cover is pulled out. Technical Solutions
[0008] The present invention aims to provide a protective prefilled syringe, which is designed to prevent the needle cover from moving along the axial direction of the syringe when the needle cover is pulled out.
[0009] The technical solution adopted by the present invention to solve the above problems is: a protective prefilled syringe, comprising:
[0010] Syringes, used to package liquids;
[0011] A needle seat unit is mounted at the distal end of the syringe;
[0012] a needle, mounted on the needle hub unit and connected to the syringe to allow the liquid to flow;
[0013] a protective cover unit, at least partially sleeved on the syringe, and at least partially sleeved on the needle base unit;
[0014] a needle sheath, at least partially sheathed on the needle hub unit to completely sheath the needle;
[0015] The needle seat unit includes a convex ridge and a spacing step provided on the distal end surface of the convex ridge and used for lifting the needle sleeve.
[0016] The presence of the spacing step ensures that the needle guard does not completely adhere to the distal end surface of the ridge when the needle guard is mounted on the needle. As a result, when the protective cover unit is pulled upward along the proximal end to completely expose the needle guard, there is no overlapping portion between the needle guard and the protective cover unit. That is, when the needle guard is pulled out along the axial direction, the protective cover unit will not be moved at all, thereby avoiding the phenomenon of accidentally moving the protective cover unit when the needle guard is pulled out.
[0017] A further preferred technical solution is that: the protective cover unit includes a protective cover, and a shrink ring provided at the distal end of the protective cover and used for engaging the ridge piece.
[0018] A further preferred technical solution is that: the needle seat unit further includes a needle seat for mounting the needle, and the ridge piece is arranged on the needle seat.
[0019] A further preferred technical solution is that the needle seat unit further includes an expansion step provided on the needle seat and used for mounting the needle sleeve.
[0020] A further preferred technical solution is that the expansion step is connected to the spacing step.
[0021] A further preferred technical solution is that the convex ridge member includes a distal stop surface, a proximal stop surface, and a side stop surface for connecting the distal stop surface and the proximal stop surface.
[0022] A further preferred technical solution is that the spacing step is provided on the distal stop surface.
[0023] A further preferred technical solution is that: the shrink ring includes a distal stop ring surface and a proximal stop ring surface; the maximum diameter of the distal stop ring surface is smaller than the minimum diameter of the proximal stop ring surface.
[0024] A further preferred technical solution is that the minimum diameter of the distal stop annular surface is greater than the maximum diameter of the distal stop surface.
[0025] A further preferred technical solution is that the maximum diameter of the distal stop ring surface is smaller than the minimum diameter of the proximal stop surface.
[0026] A further preferred technical solution is that: a guide slope is provided at the distal end of the syringe; the protective cover unit also includes a cantilever arranged at the proximal end of the protective cover and used to lift the distal stop surface, and a stop hook arranged at the proximal end of the protective cover and used to engage the proximal stop surface.
[0027] A further preferred technical solution is that: a position indicating ring is provided at the proximal end of the needle sleeve, and the minimum outer diameter of the position indicating ring is greater than the maximum inner diameter of the distal stop ring surface.
[0028] A further preferred technical solution is that: two, three, or four interval steps are provided, and the angles between the interval steps are equal.
[0029] A further preferred technical solution is that a guide slope is provided at the distal end of the syringe.
[0030] A further preferred technical solution is that the needle cover material includes one of polypropylene, polyethylene, and polystyrene, or a combination thereof. Beneficial effects
[0031] In summary, completely separating the protective cover from the needle sleeve ensures that the protective cover does not come into contact with the needle sleeve when it is removed from the needle, which can bring the following benefits:
[0032] 1. Avoid misoperation: Separating the protective cover from the needle sleeve prevents the protective cover from accidentally sliding when removing the needle sleeve. This reduces the risk of misoperation and ensures that the operator can safely remove the needle sleeve without disturbing the position of the protective cover.
[0033] 2. Improved stability: By separating the protective cover from the needle sleeve, the protective cover can be ensured to remain stable during the needle sleeve removal process. This can prevent the protective cover from accidentally sliding or falling to the distal end, reduce the false triggering rate, and improve overall safety.
[0034] 3. Convenient and Fast: The design of the separate protective cover and needle sleeve makes operation more convenient and quick. The operator can focus on removing the needle sleeve without paying extra attention to the position of the protective cover. This saves time and energy and improves operational efficiency.
[0035] 4. Simplify design and manufacturing: Separating the protective cover from the needle sleeve can simplify the overall design and manufacturing process. There is no need to consider the coupling and coordination between the needle sleeve and the protective cover, which reduces manufacturing costs and complexity.
[0036] In general, completely separating the protective cover from the needle guard can prevent misuse, improve safety, increase convenience, and simplify the design and manufacturing process. This design can further enhance the safety and ease of use of prefilled syringes. BRIEF DESCRIPTION OF THE DRAWINGS
[0037] FIG1 is a schematic structural diagram of a protective prefilled syringe.
[0038] FIG2 is a schematic diagram of the explosion of the protective prefilled syringe in FIG1 .
[0039] FIG3 is a schematic diagram of a cross section of the protective prefilled syringe in FIG1 along line AA′.
[0040] FIG4 is a schematic diagram of the protective cover unit in FIG3 sliding toward the proximal end.
[0041] FIG5 is an enlarged schematic diagram of area C in FIG4 .
[0042] FIG6 is a schematic structural diagram of the syringe and needle seat unit.
[0043] Figure 7 is a schematic diagram of the cross-sectional structure of the syringe and needle seat unit
[0044] FIG8 is a schematic structural diagram of a protective cover unit.
[0045] FIG9 is a schematic diagram of the cross-sectional structure of the protective cover unit.
[0046] FIG10 is a schematic structural diagram of a needle sleeve.
[0047] FIG11 is an enlarged schematic diagram of area B in FIG7 .
[0048] FIG12 is a schematic diagram of the front view of the cross section of the needle seat unit in FIG11.
[0049] FIG13 is a schematic diagram showing the protective cover unit being engaged with the needle seat unit after the needle sleeve is removed.
[0050] In the accompanying drawings, the components represented by each reference numeral are as follows: syringe 1, needle seat unit 2, needle, protective cover unit 4, needle sleeve 5, guide slope 101, ridge member 201, spacing step 202, needle seat 203, expansion step 204, protective cover 401, shrinkage ring 402, cantilever 403, stop hook 404, indicating ring 501, distal stop surface 201a, proximal stop surface 201b, side stop surface 201c, distal stop ring surface 402a, proximal stop ring surface 402b. Modes for Carrying Out the Invention
[0051] definition:
[0052] 1. Distal end: refers to the syringe and the various components installed on the syringe in a normal manner, which is the end facing the needle.
[0053] 2. Proximal end: refers to the syringe and the various components installed on the syringe in a normal manner, which is away from the needle.
[0054] 3. Axis: refers to the line connecting the centroids of all cross sections of a component with a symmetrical cross section.
[0055] 4. Open: refers to the ability to expose the needle or needle sheath during operation.
[0056] 5. Closed: refers to the ability to cover the needle or needle cover during operation.
[0057] 6. Socketing: refers to the act of installing component one on the outer surface of component two when the inner diameter of component one is larger than the outer diameter of component two.
[0058] 7. Setting: refers to any method used to combine two parts together, such as bonding, snapping, welding, screwing, placement, etc.
[0059] 8. Lifting: refers to component one exerting force on component two, causing component two to move in a direction opposite to the position of component one.
[0060] 9. Minimum / Maximum Diameter: For components with a distinct axis, a cross-section perpendicular to the axis is taken. If the cross-section is approximately circular or polygonal, the narrowest portion of the cross-section is the minimum diameter of the component, and the widest portion of the cross-section is the maximum diameter. The minimum diameter of a given cross-section should not be greater than its maximum diameter.
[0061] The present invention will be further described in detail below with reference to the accompanying drawings.
[0062] This specific embodiment is merely an explanation of the present invention and is not intended to limit the present invention. After reading this specification, those skilled in the art may make non-creative modifications to this embodiment as needed. However, as long as such modifications are within the scope of the claims of the present invention, they are protected by patent law. Example 1
[0063] In this embodiment, the protective prefilled syringe includes: a syringe 1, a needle seat unit 2, a needle, a protective cover unit 4, and a needle cover 5, wherein:
[0064] The needle hub unit 2 includes a ridge member 201 and a step 202 .
[0065] The protective cover unit 4 includes a protective cover 401 and a shrink ring 402 .
[0066] Referring to Figure 1, a schematic diagram of the structure of a protective prefilled syringe is shown. It includes a syringe 1 for encapsulating liquid, and a protective cover unit 4 at least partially attached to the syringe 1. The figure shows the protective prefilled syringe in its unused state, with the protective cover unit 4 attached to the syringe 1 and completely covering the needle guard 5. The protective cover unit 4 is coaxial with the syringe 1 and can slide proximally along the syringe 1.
[0067] Refer to Figure 2, which shows an exploded view of the protective prefilled syringe shown in Figure 1. The needle hub unit 2 is mounted on the distal end of the syringe barrel 1; the needle is mounted on the hub unit 2 and communicates with the syringe barrel 1 to allow fluid flow; and the needle guard 5 is used to receive the needle. While the needle is not shown for ease of illustration, the specific location of the needle in the hub unit 2 can be imagined from a typical syringe. The syringe barrel 1, the hub unit 2, the protective cover unit 4, and the needle guard 5 all share a common axis.
[0068] Referring to Figure 3, a schematic diagram of the protective prefilled syringe shown in Figure 1, taken along line AA', is shown. It can be seen that the syringe 1 has a cylindrical hollow structure for encapsulating liquid. The syringe 1 is also equipped with an injection piston, as used in conventional syringes. By pushing the injection piston, the liquid medicine is pushed into the needle hub unit 2. The needle hub unit 2 has a channel at its axis that connects to the cylindrical cavity within the syringe 1. This channel also connects to the hollow structure within the needle, allowing liquid entering the needle hub unit 2 to pass through the needle to complete the injection process. A protective cover unit 4 can be seen, which is at least partially fitted onto the syringe 1 and at least partially fitted onto the needle hub unit 2. Furthermore, a needle cap 5 is at least partially fitted onto the needle hub unit 2 to completely fit the needle.
[0069] Referring to Figure 4, there is shown a schematic diagram of the shield unit sliding toward the proximal end in Figure 3. This step is to expose the needle guard 5 to the outside, so as to facilitate the next step of removing the needle guard toward the distal end and exposing the needle for injection.
[0070] Referring to Figure 6, a schematic diagram of the structure of the syringe and needle hub unit is shown. It can be seen that the needle hub unit 2 includes a ridge 201 and spaced steps 202 provided on the distal end of the ridge 201. The figure shows a scene in which four spaced steps 202 are provided on the distal end of the ridge 201, and the angles between each spaced step 202 are 90 degrees.
[0071] Referring to Figure 8, a schematic diagram of the structure of the protective cover unit is shown. It can be seen that the protective cover unit 4 includes a protective cover 401 and a shrinking ring 402 disposed at the distal end of the protective cover 401. The shrinking ring 402 is structured to gradually shrink from the proximal end to the distal end, and a distal stop ring surface 402a is formed at the distal end of the shrinking ring 402. Conversely, a proximal stop ring surface 402b is formed at the beginning of the shrinking ring 402.
[0072] Referring to Figure 11 , an enlarged schematic diagram of region B in Figure 7 is shown. It can be seen that the ridge member 201 gradually expands outward from the distal end to the proximal end, forming a frustum structure. The frustum has a smaller bottom surface and a larger bottom surface. The smaller bottom surface is the distal stop surface 201a, and the larger bottom surface is the proximal stop surface 201b. The curved side surfaces of the frustum constitute the lateral stop surfaces 201c.
[0073] Referring to Figure 5, an enlarged schematic view of area C in Figure 4 is shown. It can be seen that when the protective cover 401 is pulled proximally until the shrink ring 402 contacts the ridge 201, the distal stop surface 402a is able to pass over the distal stop surface 201a because the minimum diameter of the distal stop surface 402a is greater than the maximum diameter of the distal stop surface 201a. Furthermore, the maximum diameter of the distal stop surface 402a is smaller than the minimum diameter of the proximal stop surface 402b. Therefore, the distal stop surface 402a cannot pass over the proximal stop surface 402b. Ultimately, the distal stop surface 402a comes to rest and abuts the lateral stop surface 201c. Furthermore, due to the presence of the spacing step 202, the proximal end of the needle guard 5 does not abut the distal stop surface 201a, so the shrink ring 402 is completely separated from the needle guard 5. In other words, the process of removing the needle guard 5 does not affect the protective cover 401. And because the distal stop ring surface 402a cannot cross the proximal stop ring surface 402b, no matter how the operator pulls the protective cover 401, the protective cover 401 will not be directly pulled completely onto the syringe 1. The advantage of this is that the protective cover 401 is always at the distal end of the syringe, which is convenient for the operator to operate with one hand. Example 2
[0074] In this embodiment, the structure of the protective prefilled syringe is substantially the same as that of the first embodiment, except that the minimum outer diameter of the needle guard 5 is greater than the maximum inner diameter of the distal stop ring surface 402a.
[0075] Referring to Figure 10, a schematic diagram of the needle guard's structure is shown. It can be seen that the position indicator ring 501, located at the proximal end of the needle guard 5, has the largest outer diameter of the entire guard 5. Referring again to Figure 5, operators often wish to know to what extent the protective cover 401 must be pulled proximally for the retraction ring 402 to completely separate from the guard 5. The guard 5 is made of a material capable of undergoing a certain degree of elastic deformation, such as polypropylene, polyethylene, or polystyrene. When the minimum outer diameter of the positioning ring 501 is larger than the maximum inner diameter of the distal stop ring surface 402a, the distal stop ring surface 402a will be blocked by the positioning ring 501 when it just contacts the positioning ring 501. At this time, if the protective cover 401 is pulled hard, the positioning ring 501 can be squeezed to make the distal stop ring surface 402a pass over the positioning ring 501, and this force application process can give the operator a message, that is, at this time the shrink ring 402 is completely out of the area where the needle sleeve 5 is located, and pulling out the needle sleeve 5 at this time will not have any impact on the protective cover 401. Example 3
[0076] In this embodiment, the structure of the protective prefilled syringe in the first or second embodiment is included, and in addition:
[0077] The protective cover unit 4 further includes a cantilever 403 and a stop hook 404 .
[0078] Referring to Figure 8, a schematic diagram of the structure of the protective cover unit is shown. It can be seen that the protective cover unit 4 also includes a cantilever 403 disposed at the proximal end of the protective cover 401, and a stop hook 404 disposed at the proximal end of the protective cover 401. The stop hook 404 has a mounting slot, and the cantilever 403 is located in the mounting slot.
[0079] Referring to Figure 13, a schematic diagram illustrating the protective cover unit engaging with the needle hub unit after the needle guard has been removed is shown. As can be seen, when the protective cover 401 is engaged with the ridge member 201, the proximal end surface of the cantilever 403 abuts against the distal stop surface 201a, and the distal end surface of the stop hook 404 hooks onto the proximal stop surface 201b, one in front of the other, to secure the protective cover 401 to the ridge member 201.
[0080] In addition, when the needle guard 5 is sleeved on the needle hub unit 2, the needle guard 5 just pushes the cantilever 403 outward, so that the proximal end surface of the cantilever 403 no longer rests on the distal stop surface 201a. At this time, the protective cover 401 can be pulled proximally. After the needle guard 5 is removed, the protective cover 401 is pulled distally, so that the proximal end surface of the cantilever 403 rests on the distal stop surface 201a, and the distal end surface of the stop hook 404 is hooked on the proximal stop surface 201b, that is, the protective cover 401 is stuck on the ridge member 201.
[0081] In summary, in this embodiment, the method for using the protective prefilled syringe is as follows:
[0082] S01. Pull the protective cover 401 proximally until the shrink ring 402 rests against the ridge member 201;
[0083] S02. Remove the needle sheath 5 and complete the injection;
[0084] S03. Pull the protective cover 401 toward the distal end, so that the cantilever 403 falls and engages with the stop hook 404 to be clamped on the ridge member 201, thereby completely covering the needle. Example 4
[0085] In this embodiment, the structure of the protective prefilled syringe in the first embodiment, the second embodiment, or the third embodiment is included, and in addition:
[0086] The needle seat unit 2 further includes a needle seat 203 and an expansion step 204 .
[0087] Referring again to FIG. 11 , it can be seen that needle hub 203 has a hollow structure with inwardly extending needle mounting protrusions disposed therein. A needle can be mounted between the respective needle mounting protrusions and inserted continuously along the hollow structure of needle hub 203 until it communicates with syringe 1. Expansion steps 204 are disposed on the outer surface of needle hub 203, the same number as spacing steps 202. The expansion steps serve to press the inner surface of needle guard 5 outward when needle guard 5 is mounted on needle hub 203, thereby ensuring a more secure attachment of needle guard 5 to needle hub 203 even in the presence of spacing steps 202.
[0088] In addition, the same or similar reference numerals are used in the drawings and description to refer to the same or similar parts or steps whenever possible. The drawings are presented in simplified form and are not drawn to exact scale. For convenience and clarity only, directional terms such as top, bottom, left, right, upward, above, above, below, below, rear, and front may be used in the drawings. These and similar directional terms should not be construed as limiting the scope of this disclosure in any way.
Claims
1. A protective prefilled syringe, comprising: A syringe (1), used for packaging liquid; A needle seat unit (2) mounted at the distal end of the syringe (1); A needle, mounted on the needle seat unit (2) and connected to the syringe (1) to allow the liquid to flow; A protective cover unit (4) at least partially sleeved on the syringe (1) and at least partially sleeved on the needle seat unit (2); A needle sleeve (5) at least partially sleeved on the needle hub unit (2) to completely sleeve the needle; The needle seat unit (2) is characterized in that it comprises a convex ridge member (201) and a spacing step (202) arranged on the distal end surface of the convex ridge member (201) and used to lift the needle sleeve (5).
2. A protective prefilled syringe according to claim 1, characterized in that: The protective cover unit (4) comprises a protective cover (401) and a shrink ring (402) arranged at the far end of the protective cover (401) and used for engaging the convex ridge piece (201).
3. A protective prefilled syringe according to claim 1, characterized in that: The needle seat unit (2) further comprises a needle seat (203) for mounting the needle, and the convex ridge member (201) is arranged on the needle seat (203).
4. A protective prefilled syringe according to claim 3, characterized in that: The needle seat unit (2) further comprises an expansion step (204) arranged on the needle seat (203) and used for mounting the needle sleeve (5).
5. A protective prefilled syringe according to claim 4, characterized in that: The expansion step (204) is connected to the spacing step (202).
6. A protective prefilled syringe according to claim 2, characterized in that: The convex ridge member (201) comprises a distal stop surface (201a), a proximal stop surface (201b), and a side stop surface (201c) used for connecting the distal stop surface (201a) and the proximal stop surface (201b).
7. A protective prefilled syringe according to claim 6, characterized in that: The spacing step (202) is arranged on the distal end stop surface (201a).
8. The protective prefilled syringe according to claim 6, characterized in that: The contraction ring (402) comprises a distal stop ring surface (402a) and a proximal stop ring surface (402b); the maximum diameter of the distal stop ring surface (402a) is smaller than the minimum diameter of the proximal stop ring surface (402b).
9. The protective prefilled syringe according to claim 8, characterized in that: The minimum diameter of the distal stop ring surface (402a) is greater than the maximum diameter of the distal stop surface (201a).
10. The protective prefilled syringe according to claim 8, characterized in that: The maximum diameter of the distal stop ring surface (402a) is smaller than the minimum diameter of the proximal stop surface (201b).
11. The protective prefilled syringe according to claim 6, characterized in that: The protective cover unit (4) further comprises a cantilever (403) arranged at the proximal end of the protective cover (401) and used to lift up the distal stop surface (201a), and a stop hook (404) arranged at the proximal end of the protective cover (401) and used to engage with the proximal stop surface (201b).
12. The protective prefilled syringe according to claim 8, characterized in that: A positioning ring (501) is provided at the proximal end of the needle sleeve (5), and the minimum outer diameter of the positioning ring (501) is greater than the maximum inner diameter of the distal stop ring surface (402a).
13. The protective prefilled syringe according to claim 1, characterized in that: The number of the spacing steps (202) is two, three, or four, and the angles between the spacing steps (202) are equal.
14. The protective prefilled syringe according to claim 1, characterized in that: The distal end of the syringe (1) is provided with a guiding inclined surface (101).
15. The protective prefilled syringe according to claim 1, characterized in that: The needle sleeve (5) material comprises one or more combinations of polypropylene, polyethylene and polystyrene.
Citation Information
Patent Citations
Safety needle assembly
CN101912651A
Needle protection type pre-filled syringe
CN114642792A
Pre-filled syringe with front shield
CN114642793A
Pre-filled syringe with protective cover, assembly of pre-filled syringe, assembly assembling method and medicine filling method
CN114652920A
Articulated needle shield and needle assembly
CN115052646A