Pre-filling needle with reinforcing rib at tail part
By designing a reinforcing rib structure at the tail of the pre-filled needle, the problem of insufficient sealing under low-temperature storage conditions is solved, and the stability and safety of the pre-filled needle in low-temperature environments are achieved, making it suitable for the preservation of cell and gene therapy drugs.
Patent Information
- Application Number
- CN202423040487.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-10
- Publication Date
- 2025-11-25
- Estimated Expiration
- 2034-12-10
AI Technical Summary
Existing vials and pre-filled syringes are not airtight enough under low-temperature storage conditions, which cannot meet the preservation requirements of cell and gene therapy drugs and poses a risk of drug leakage and contamination.
A pre-filled needle with a reinforcing rib at the tail was designed. By setting a reinforcing rib structure between the rivet cap and the flange, the stability and sealing of the needle tail are enhanced, deformation caused by temperature changes is reduced, and the integrity and safety of the medicine are ensured during low-temperature storage.
It improves the sealing performance and structural stability of the pre-filled needle in low-temperature environments, prevents drug leakage and contamination, ensures the stability and consistency of drug quality, and meets the low-temperature storage requirements of cell and gene therapy drugs.
Smart Images
Figure CN223586340U_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The utility model relates to the field of medical apparatus and instruments, especially to pre-filled syringe. BACKGROUND
[0002] Cell and gene therapy (CGT) products in clinical applications usually include gene therapy products, vaccines, stem cell gene therapy products, immune cell therapy products, etc. These products have important value in treating human diseases. Such drugs are extremely sensitive to temperature, and improper storage conditions can lead to drug failure and reduced efficacy. In the selection of cell therapy product formulation forms, although fresh cell preparations have their advantages, with industry research and technological progress, the mainstream view gradually tends to use cryopreservation form. Cryopreserved cell preparations are more in line with the basic characteristics of drug preparations, which is conducive to arranging production, completing necessary finished product testing and release procedures, supporting multi-dose production and large-scale application, and also meets the requirements of new drug application (NDA) form.
[0003] For cell and gene therapy drugs, the current industry sterile cryopreservation packaging form mainly uses a vial cryopreservation packaging. After aseptic filling, plugging and capping process, the vial is stored and transported at low temperature after freezing. When used clinically, medical staff reconstitutes the drug and administers it to patients using a syringe, i.e. the "vial + syringe" process.
[0004] However, vial packaging has limitations in low-temperature storage. At low temperatures, the expansion of the bottle body and the rubber plug, as well as the low-temperature brittleness of the aluminum cap, affect its sealing effect, so vial packaging integrity and sealing are challenged at low temperatures. The low-temperature capping process is difficult to develop and cannot fully meet the needs of the CGT industry for low-temperature storage.
[0005] Although pre-filled syringes (PFS) have advantages such as convenience, dose accuracy and safety at room temperature, the current pre-filled syringe packaging process mainly includes filling and plugging, which cannot meet the packaging requirements of temperature-sensitive drugs that need to be cryopreserved. Low-temperature preservation involves a temperature change process from freezing to reconstitution. During the temperature change process, the materials of the pre-filled syringe may shift due to temperature changes, damaging the sealing of the drug package and causing leakage, and the drug may be contaminated by particles and microorganisms.
[0006] Therefore, whether it is a vial or a pre-filled syringe, there are limitations in low-temperature storage, and it cannot fully meet the requirements of the CGT industry for low-temperature preservation of drugs. The industry urgently needs to develop a new type of packaging form that can adapt to low-temperature storage and ensure drug quality and safety to promote the clinical application and industrialization development of CGT products. SUMMARY
[0007] In order to solve the above problems, the utility model provides a kind of pre-filled needle with reinforcing rib in tail part, which can keep stable sealing effect and has high strength.
[0008] In order to achieve the above purpose, the utility model discloses a pre-filled needle with reinforcing rib in tail part, which comprises a needle tube, a plunger and an injection head, the injection head is arranged at the front end of the needle tube, the plunger is sealingly arranged in the needle tube and forms a space for containing pre-filled medicament between the injection head, the tail end of the needle tube is provided with a flange with a convex edge, a rivet cover is arranged on the flange with a convex edge to seal the opening of the tail part of the needle tube, a sealing gasket is arranged between the rivet cover and the tail flat surface of the flange with a convex edge, and a reinforcing rib is formed on the tail flat surface in the form of a ring and protrudes towards the sealing gasket.
[0009] Further, in the cross section of the reinforcing rib, the width of the connecting part of the reinforcing rib and the tail flat surface is greater than the width of the contact part of the reinforcing rib and the sealing gasket.
[0010] The size of the reinforcing rib protruding from the tail flat surface is 0.4-0.5mm, and in the profile of the cross section of the reinforcing rib, the slope of the first edge close to the inner side of the needle tube is greater than the slope of the second edge close to the outer side of the needle tube.
[0011] The first edge is a straight line and is connected to the straight line where the tail flat surface is located through a first round corner, and the second edge is a curve directly connected to the straight line where the tail flat surface is located.
[0012] The angle between the first edge and the diameter of the needle tube is 30 degrees, and the second edge is a circular arc with a radius of 0.8mm.
[0013] The first edge and the second edge are connected through a circular arc with a radius of 0.1mm, and the first edge and the straight line where the tail flat surface is located are connected through a circular arc with a radius of 0.3mm.
[0014] Further, the reinforcing rib is two, and the cross section profiles of the two reinforcing ribs are in mirror image relationship.
[0015] The utility model provides a kind of pre-filled needle with reinforcing rib in tail part, which designs reinforcing rib structure to enhance its overall stability in low temperature environment. By reducing the shrinkage and expansion of materials at low temperature, the reinforcing rib effectively reduces the deformation caused by temperature change, improves the structural stability of the flange with a convex edge of the tail part of the needle tube, and thus ensures the integrity and safety of the drug during low-temperature storage.
[0016] On the other hand, rivet cover may cause large pressure concentration when fixing flange with a convex edge, and reinforcing rib design can effectively disperse and balance this pressure. This method not only improves the strength of the tail structure, but also prevents deformation or damage caused by pressure concentration, so that the overall pressure resistance and structural stability of the pre-filled needle are improved.
[0017] Under the riveting cover pressure, the reinforcing rib forms a transverse fixation to the sealing gasket, reduces the risk of displacement of the sealing gasket due to temperature change, avoids the possible drug pollution due to sealing failure, and improves the sealing performance of the pre-filled needle under different temperature conditions.
[0018] Meanwhile, the size of the reinforcing rib and its related components is designed in detail to ensure that the adhesion of the sealing gasket and the needle tube is not affected while the reinforcing rib structure is increased. This precise size design ensures the strength of the structure and maintains excellent sealing effect.
[0019] In summary, the pre-filled needle with a reinforcing rib at the tail part is designed, the reinforcing rib structure is creatively designed on the sealing surface to cope with the expansion, shrinkage and sealing failure problems that may occur during low-temperature storage, thereby providing a safe and reliable drug storage environment. The sealing design of the riveting cover structure design has low production complexity, is convenient for large-scale production, and can also ensure the stability and consistency of product quality. BRIEF DESCRIPTION OF DRAWINGS
[0020] Figure 1 is a sectional view of the pre-filled needle with a reinforcing rib at the tail part of Example 1.
[0021] Figure 2 is an enlarged view of A in Example 1. Figure 1
[0022] Figure 3 is a finite element analysis diagram of the adhesion of the sealing gasket and the convex flange of Example 1.
[0023] Figure 4 is a sectional view of the convex flange of Example 2.
[0024] Figure 5 is a finite element analysis diagram of the adhesion of the sealing gasket and the convex flange of Example 2.
[0025] Figure 6 is a structural schematic diagram of the convex flange of Example 3.
[0026] Figure 7 is a finite element analysis diagram of the adhesion of the sealing gasket and the convex flange of Example 4.
[0027] Figure 8 is a structural schematic diagram of the convex flange of Example 4. DETAILED DESCRIPTION
[0028] The preferred embodiments of the present application are described below in conjunction with the accompanying drawings, and it should be understood that the preferred embodiments described herein are only used to illustrate and explain the present application, and are not used to limit the present application.
[0029] Example 1.
[0030] As Figure 1 shown in the embodiment, the pre-filled needle with the reinforcing rib 6 includes a needle tube 1, a plunger (not shown in the figure) and a injection head 2 (not shown in the figure), the injection head 2 is arranged at the front end of the needle tube 1, the plunger is sealingly arranged in the needle tube 1 and forms a pre-filled medicament containing space with the injection head 2, the tail end of the needle tube 1 is provided with a flange 3, the flange 3 is provided with a rivet cover (not shown in the figure) closing the tail end opening of the needle tube 1, and a sealing gasket 5 is arranged between the rivet cover and the tail end plane 4 of the flange 3, the tail end plane 4 is formed with a reinforcing rib 6 in the shape of a ring and protruding towards the sealing gasket 5.
[0031] As Figure 2 shown, in the cross section of the reinforcing rib 6, the reinforcing rib 6 is connected with the tail end plane 4 and forms a whole triangle. The size of the reinforcing rib 6 protruding from the tail end plane 4 is 0.4mm, the top is a circular chamfer 7 with a radius of 0.1mm, the first side 8 close to the inner side of the needle tube 1 is a straight line, and the included angle α with the diameter of the needle tube 1 is 30°, the end of the first side 8 is connected with the straight line where the tail end plane 4 is located through a first circular corner 9, and the first circular corner 9 is a circular arc with a radius of 0.3mm.
[0032] In the cross section of the reinforcing rib 6, the second side 10 close to the outer side of the needle tube 1 is a circular arc curve with a radius of 0.8mm, and is directly connected with the straight line where the tail end plane 4 is located.
[0033] It should be noted that in the embodiment, the slope of the second side 10 is taken as the chord of the circular arc line.
[0034] The above structure is subjected to finite element analysis, the needle tube 1 and the flange 3 are set as rigid materials, the sealing gasket 5 is set as rubber of 45A, and Neo-Hookean model is adopted. The contact type of the flange 3 and the sealing gasket 5 is rough (no penetration, separable, no slip), and the analysis type is: direct solver, large deformation open; the boundary condition is: the flange 3 does not displace in Y direction, the sealing gasket 5 displaces in Y direction +2mm, corresponding to 1mm compression of 3mm thick rubber gasket. In the following embodiments, finite element analysis is adopted, and the conditions are consistent.
[0035] The final analysis result is shown in Figure 3 .
[0036] After the sealing gasket 5 is deformed by the rivet cover, the shape of the sealing gasket 5 is deformed in cooperation with the reinforcing rib 6, that is, the reinforcing rib 6 is extruded to the surface of part of the sealing gasket 5, it can be seen that the deformation of the sealing gasket 5 at the tip of the reinforcing rib 6 is the largest and is red, thereby forming a limitation on the transverse position of the sealing gasket 5.
[0037] Embodiment 2.
[0038] As Figure 4 , 5 shown, the tail of the pre-filled needle with reinforcing rib described in this embodiment is different from that of embodiment 1 in that the second side 10 is a straight line, the angle β between the second side 10 and the diameter of the needle tube 1 is 60°, and the end of the second side 10 is fixedly connected to the straight line where the tail plane 4 is located through the second round corner 11, and the second round corner 11 is a circular arc with a radius of 0.3 mm.
[0039] As Figure 5 can be seen, after being pressed by the riveting cover, the sealing gasket 5 and the flange 3 with a convex edge can also be well fitted.
[0040] Embodiment 3.
[0041] As Figures 7-8 shown, the tail of the pre-filled needle with reinforcing rib described in this embodiment is different from that of embodiment 1 in that the second side 10 is a straight line, the angle α between the second side 10 and the diameter of the needle tube 1 is 30°, and the end of the second side 10 is fixedly connected to the straight line where the tail plane 4 is located through the first round corner 9, and the first round corner 9 is a circular arc with a radius of 0.3 mm. That is, the first side 8 and the second side 10 of the reinforcing rib 6 and the curves where they transition to the tail plane 4 are completely symmetrical.
[0042] As Figure 8 can be seen, after being pressed by the riveting cover, the sealing gasket 5 and the flange 3 with a convex edge can also be well fitted.
[0043] Specifically, the finite element analysis results of the three embodiments are analyzed as follows:
[0044] In the Figure 8 of embodiment 3, the left side of the reinforcing rib 6 has a relatively obvious gap, but the outside of the gap is well fitted with the sealing gasket 5 and the tail plane 4.
[0045] In the Figure 5 of embodiment 2, the right side of the reinforcing rib 6 has a very small gap that is almost invisible and can be ignored, and other parts are well fitted, and the sealing effect is better than that of embodiment 3.
[0046] In the Figure 3 of embodiment 1, the sealing gasket 5 is well fitted with the reinforcing rib 6, and from the overall shape, the width of the reinforcing rib 6 on the tail platform is smaller than that of embodiment 2. Therefore, under the condition of achieving the same effect as embodiment 2, it uses less material, and it is also beneficial to obtain the mold ejection area in production, and it is the optimal scheme among the three embodiments.
[0047] Embodiment 4.
[0048] As Figure 6As shown, the embodiment described in the tail with the reinforcing rib 6 of the pre-filled needle, in the convex flange 3 tail plane 4 has two circles of reinforcing rib 6. The inner circle reinforcing rib 6 contour size and position are exactly the same as embodiment 1, and the outer circle reinforcing rib 6 contour shape is mirror image with the inner circle reinforcing rib 6. By two mirror image reinforcing rib 6, the sealing gasket 5 can be formed from two directions respectively to the horizontal movement of the obstacles, so as to better fix the position of the sealing gasket. At the same time, two circles of reinforcing rib 6 also form a certain labyrinth effect, to a certain extent, improve the sealing effect.
[0049] In the description of the present application, it should be pointed out that the terms "vertical", "upper", "lower", "horizontal" and the like indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, therefore it cannot be understood as a limitation of the present application.
[0050] In the description of the present application, it should be pointed out that, unless otherwise specified and limited, the terms "set", "install", "connect", "connect" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or indirectly connected through an intermediate medium, or it can be the communication between two elements. For ordinary skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.
[0051] Finally, it should be pointed out that: the above only for the preferred embodiments of the present application, and not for the limitation of the present application, although the present application has been described in detail with reference to the foregoing embodiments, for those skilled in the art, it can still modify the technical solutions recorded in the foregoing embodiments, or make equivalent replacement for some technical features. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application shall be included in the protection scope of the present application.
Claims
1. A pre-filled needle with a reinforcing rib at the tail, comprising a needle tube, a plunger and an injection head, the injection head is arranged at the front end of the needle tube, the plunger is sealingly arranged in the needle tube and forms a pre-filled medicament containing space with the injection head, characterized in that: The tail end of the needle tube is provided with a flange, a rivet cover is arranged on the flange to seal the opening of the tail end of the needle tube, a sealing gasket is arranged between the rivet cover and the tail end plane of the flange, and a reinforcing rib is formed on the tail end plane and protrudes towards the sealing gasket.
2. The rib-reinforced pre-charged syringe of claim 1 wherein In the cross section of the reinforcing rib, the width of the connecting part of the reinforcing rib and the tail end plane is greater than the width of the contact part of the reinforcing rib and the sealing gasket.
3. The pre-filled needle with a tail end and a reinforcing rib according to claim 2, wherein the size of the reinforcing rib protruding from the tail end plane is 0.4-0.5 mm, and in the cross section of the reinforcing rib, the slope of the first side close to the inner side of the needle tube is greater than the slope of the second side close to the outer side of the needle tube.
4. The pre-filled needle with a tail end and a reinforcing rib according to claim 3, wherein in the cross section of the reinforcing rib, the first side is a straight line and is connected to the straight line of the tail end plane through a first round corner, and the second side is a curved line and is directly connected to the straight line of the tail end plane.
5. The pre-filled needle with a tail end and a reinforcing rib according to claim 4, wherein in the cross section of the reinforcing rib, the first side forms an angle of 30 degrees with the diameter of the needle tube, and the second side is a circular arc line with a radius of 0.8 mm.
6. The rib-reinforced pre-charged syringe of claim 3 wherein The first side and the second side are connected through a circular arc line with a radius of 0.1 mm, and the first side and the straight line of the tail end plane are connected through a circular arc with a radius of 0.3 mm.
7. The rib-reinforced pre-charged syringe of any of claims 1-6, wherein The reinforcing rib is two, and the cross section profiles of the two reinforcing ribs are mirror images.