Luer taper with exhaust function and pre-filling needle

Abstract

According to the Luer taper with the exhaust function and the pre-filling needle, the Luer taper comprises a first connector and a second connector, the first connector and the second connector are connected through threads, and the first connector or the second connector is provided with an exhaust structure communicated with the outside. The exhaust structures are arranged in the radial direction and the axial direction respectively. The exhaust structure is arranged on the Luer taper, so that internal gas can be exhausted in time when internal and external air pressures of the taper are different, and the risk of fracture of the taper caused by accumulation of gas pressure in a low-temperature liquid nitrogen storage environment is avoided.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to Luer connectors and pre-filled syringes. Background Technology

[0002] Cell and gene therapy (CGT) products in clinical applications typically include gene therapy products, vaccines, stem cell gene therapy products, and immune cell therapy products, which are of significant value in treating human diseases. These drugs are extremely sensitive to temperature; improper storage conditions can lead to drug inactivation and reduced efficacy. Regarding the choice of formulation for cell therapy products, although fresh cell formulations have their advantages, with industry research and technological advancements, the mainstream view is increasingly favoring cryopreserved formulations. Cryopreserved cell formulations better meet the basic characteristics of drug formulations, facilitate production planning, complete necessary finished product testing and release procedures, support multi-dose production and large-scale application, and are also more compatible with the format required for New Drug Applications (NDAs).

[0003] For cell and gene therapy drugs, the current industry primarily uses vials for aseptic cryopreservation packaging. After aseptic filling, capping, and crimping, the vials are frozen and stored and transported at low temperatures. In clinical use, healthcare professionals thaw the vials and administer the medication to patients using syringes—a process known as "via vial + syringe."

[0004] However, vial packaging has shortcomings in low-temperature storage. At low temperatures, factors such as the expansion of the vial and stopper, and the brittleness of the aluminum cap, affect its sealing performance. Therefore, the integrity and airtightness of vial packaging face challenges at low temperatures. Furthermore, the development of a low-temperature capping process is difficult and cannot fully meet the low-temperature storage requirements of the CGT industry.

[0005] While pre-filled syringes (PFS) offer advantages such as convenience, dosage accuracy, and safety at room temperature, their tips are often equipped with Luer connectors for quick connection. However, during cryopreservation and thawing at low temperatures, the drastic temperature changes can cause uneven stress in the thin-walled sections of the Luer connector due to these temperature variations, potentially leading to cracks or even complete breakage.

[0006] Furthermore, when medications require cryogenic storage in liquid nitrogen, the filled syringes are directly immersed in liquid nitrogen for freezing. In this case, liquid nitrogen may seep into the threaded gaps of the Luer connector. When remelting is needed, the liquid nitrogen in these gaps rapidly vaporizes, and the excess pressure, unable to release, can cause the Luer connector to burst. Summary of the Invention

[0007] To address the aforementioned issues, this invention provides a Luer connector with venting function that meets the requirements for low-temperature storage and effectively prevents cracking of the Luer connector, as well as a syringe.

[0008] To achieve the above objectives, the present invention provides a Luer connector with an exhaust function, comprising a first connector and a second connector, wherein the first connector and the second connector are connected by threads, and the first connector or the second connector is provided with an exhaust structure that communicates with the outside.

[0009] Furthermore, the exhaust structure includes a vent hole, which is positioned in the radial direction of the Luer connector to allow gas exchange between the internal space of the Luer connector and the outside.

[0010] Furthermore, the exhaust structure includes an exhaust groove that penetrates the threaded connection structure, and the exhaust groove is disposed in the axial direction of the Luer joint.

[0011] To ensure the effectiveness of the venting groove, the bottom of the venting groove is lower than the bottom groove of the thread.

[0012] Meanwhile, the first connector is provided with a guide post, and the guide post is provided with a flow guide hole. The second connector is fixed with a plug that cooperates with the guide post.

[0013] This utility model also provides a pre-filled needle, including a needle tube, the front end of which is provided with the aforementioned Luer connector.

[0014] The specific solution is that the front end of the needle tube is integrally formed with the first connector and the guide post, and at least one ventilation hole is provided at the connection between the first connector and the needle tube.

[0015] When the second connector is fully connected to the first connector by threads, the end of the second connector directly forms a gap with the bottom of the first connector. The position of the vent hole matches the gap, and the central axis of the vent hole is inclined towards the needle tube.

[0016] The exhaust groove is provided on the first connector or on the second connector.

[0017] In summary, this utility model provides a Luer joint with a venting groove, a structural design to prevent the Luer joint from breaking due to pressure imbalance in low-temperature environments. Specifically, by providing a venting structure on the Luer joint, internal gas can be promptly discharged when a pressure difference occurs between the inside and outside of the joint, thereby avoiding the risk of joint breakage caused by gas pressure accumulation, such as in a low-temperature liquid nitrogen storage environment.

[0018] The venting structure includes radial vent holes and venting grooves through the threaded connection structure. The radial vent holes ensure gas exchange in the joint during drastic temperature changes, while the bottom of the venting groove is designed to be lower than the thread tooth groove. This design effectively enhances venting even under rapid temperature drops, further reducing the possibility of the joint breaking due to a sudden increase in gas pressure. At the same time, the through-type venting groove design segments the thread and also provides space for the thread to deform due to temperature changes.

[0019] Meanwhile, this invention also provides a pre-filled needle for cell and gene therapy drugs that require operation in low-temperature environments. This invention proposes an improved design to ensure stability and safety during cryopreservation and thawing. The pre-filled needle features an integrally molded Luer connector with venting capabilities, enabling it to adapt to drastic changes in temperature and pressure, and preventing drug leakage or failure due to connector damage.

[0020] This invention is particularly effective in the liquid nitrogen cryopreservation of cell and gene therapy agents. When a pre-filled syringe is placed in a liquid nitrogen environment for cryopreservation, liquid nitrogen may seep into and accumulate in the threaded gaps of the Luer connector. During thawing, the liquid nitrogen rapidly vaporizes, and this gas is released through a pre-designed venting structure, ensuring that the connector does not rupture due to a rapid increase in internal pressure. This maintains the sterility and safety of the agent during thawing and improves the usability of the Luer connector. Attached Figure Description

[0021] Figure 1 This is an exploded view of the overall structure of the pre-filled needle in Example 1.

[0022] Figure 2 This is a cross-sectional view of the pre-filled needle in Example 1.

[0023] Figure 3 This is an enlarged cross-sectional view of the pre-charge needle Luer connector in Example 1.

[0024] Figure 4 This is a perspective view of the exhaust groove provided on the second connector in Embodiment 1.

[0025] Figure 5 This is a cross-sectional view of the exhaust groove provided on the second connector in Embodiment 1. Detailed Implementation

[0026] The preferred embodiments of the present invention will be described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are for illustration and explanation only and are not intended to limit the present invention.

[0027] Example 1.

[0028] like Figure 1This embodiment describes a pre-filled needle, including a needle tube 1. A female head, i.e., a first connector 2, is integrally formed at the front end of the needle tube 1. A guide post 3 is provided at the center of the first connector 2 at the front end of the needle tube 1, and a flow guide hole 4 communicating with the interior of the needle tube 1 is provided at the center of the guide post 3. The inner wall of the first connector 2 has internal threads, and it is connected to a male head, i.e., a second connector 5, which has external threads on its outer wall, through the internal threads. The second connector 5 is a hollow tubular structure, and a plug 6 is provided inside the hollow tubular structure. An inwardly protruding annular retaining ring 7 is provided on the inner wall of the second connector 5. The plug 6 is confined within the second connector 5 by engaging with the annular groove on the plug 6 through the annular retaining ring.

[0029] like Figure 2 , Figure 3 As shown, the second connector 5 is screwed into the first connector 2 via a threaded connection. When it reaches its innermost limit position, a gap, or annular space 8, is formed between the end of the second connector 5 and the bottom of the first connector 2. A vent 9 is provided at this corresponding position, i.e., at the transition point between the first connector 2 and the needle tube 1. The vent 9, located on the side wall of the first connector 2, is generally radial, but it is not required to be completely parallel to the radial cross-section of the needle tube 1; it can be appropriately tilted towards the needle tube 1. This structural design, with the vent 9 located at the transition point between the first connector 2 and the needle tube 1, and the central axis of the vent 9 tilted towards the needle tube 1, is a special design for the remelting application scenario. During the remelting process, the user holds the end of the needle tube 1 and inserts it into warm water, i.e., the front end of the needle tube 1 is inserted downwards into the warm water. The vent 9, located at the connection point between the first connector 2 and the needle tube 1 and tilted towards the needle tube 1, is entirely above the Luer connector and tilted upwards, making it easier to expel gas and thus making pressure relief smoother.

[0030] In some embodiments, the number of vent holes 9 can be one or multiple evenly distributed in a ring.

[0031] The outer wall of the second connector 5 is provided with an external thread, and the end of the external thread is a ring retaining ring 10, which is used to cooperate with the front end of the first connector 2 to define the relative position of the two connectors.

[0032] like Figure 4 , Figure 5 As shown, the threaded section of the second connector 5 is provided with an exhaust groove 11 that runs through all the threads. The depth of the exhaust groove 11 formed on the outer wall of the second connector 5 is deeper than the root groove 12 of the thread, thereby preventing the thread from completely blocking the exhaust groove 11 when the threads are engaged, thus reducing the exhaust effect. In some embodiments, the number and position of the exhaust grooves 11 on the circumference are opposite to the vent hole 9.

[0033] In this embodiment, the first connector 2 has an internal thread, and the second connector 5 has an external thread. However, in some embodiments, the opposite can be true, with the internal thread on the second connector 5 and the external thread on the first connector 2. The position of the vent groove 11 is also flexible; it can be located on the first connector 2 or the second connector 5, or on either the internal or external thread. These variations do not affect the function of the vent groove 11.

[0034] Although this embodiment describes a pre-filled needle, the technical solution of this application is not limited to the field of pre-filled needles. The Luer connector and corresponding syringes equipped with Luer connectors described in this application can be used in all scenarios involving injection. As mentioned above, the venting structure at the front end of the Luer connector only connects the interior of the Luer connector to the exterior. In the entire structure, the plug and guide post are responsible for sealing. The threaded connection connects the first connector supported on the plug to the guide post on the second connector, thereby pressing the plug tightly against the guide post to provide a sealing effect.

[0035] In the description of this utility model, it should be noted that the terms "vertical", "up", "down", "horizontal", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0036] In the description of this utility model, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0037] Finally, it should be noted that the above description is merely a preferred embodiment of this utility model and is not intended to limit the utility model. Although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this utility model should be included within the protection scope of this utility model.

Claims

1. A luer fitting having a venting function comprising a first fitting and a second fitting, said first and second fittings being threadably connected, characterised in that The first joint or the second joint is provided with an exhaust structure in communication with the outside.

2. The luer connector with venting function according to claim 1, characterized in that The exhaust structure comprises a vent hole arranged in the radial direction of the luer joint, so that the internal space of the luer joint exchanges gas with the outside.

3. The luer connector with venting function according to claim 1, characterized in that The exhaust structure comprises an exhaust groove penetrating the threaded connection structure, and the exhaust groove is arranged in the axial direction of the luer joint.

4. The luer connector with venting function according to claim 3, characterized in that The bottom of the exhaust groove is lower than the tooth bottom groove of the thread.

5. The luer connector with venting function according to any one of claims 1-4, characterized in that The first joint is provided with a guide column, and the guide column is provided with a flow guide hole.

6. A pre-filled syringe comprising a needle cannula, characterized in that The front end of the needle tube is provided with the luer joint as claimed in claims 1-5.

7. The pre-filled syringe of claim 6, wherein The front end of the needle tube is integrally formed with the first joint and the guide column, and at least one vent hole is arranged at the connection between the first joint and the needle tube.

8. The pre-filled needle of claim 7, wherein When the second joint is completely connected with the first joint through the thread, the end of the second joint directly forms a gap with the bottom of the first joint, the vent hole is matched with the position of the gap, and the central axis of the vent hole is inclined towards the direction of the needle tube.

9. The pre-filled syringe of claim 8, wherein The exhaust groove is arranged on the first joint or the second joint.

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