Nitrogen filling trocar structure

Abstract

The nitrogen filling trocar structure comprises two distribution pipe assemblies and a plurality of trocar bodies, a main channel and a peripheral channel are axially arranged in each trocar body, the top of each main channel is communicated with a liquid medicine inlet, each peripheral channel is communicated with a nitrogen inlet in the side face, and the bottom end of each main channel is provided with a liquid medicine outlet, and the bottom end of each peripheral channel is provided with a nitrogen outlet; medium inlets are formed in the two ends of the distribution pipe assembly, and a plurality of medium outlets are distributed in the periphery of the distribution pipe assembly. According to the utility model, the synchronization of liquid medicine filling and nitrogen filling protection can be realized, the single operation time is obviously shortened, and the production efficiency is effectively improved. Meanwhile, the double-channel isolation design of the trocar avoids mixing of liquid medicine and nitrogen, annular nitrogen distribution is matched, and the uniformity of nitrogen charging is greatly improved, so that the control performance of the residual oxygen amount is remarkably improved, and the product quality is better guaranteed.

Description

Technical Field

[0001] This utility model relates to a needle sleeve structure that enables simultaneous filling and nitrogen filling, belonging to the field of pharmaceutical filling machinery technology. Background Technology

[0002] The chemical stability of injectable drugs is significantly correlated with the residual oxygen content inside the packaging. As a strong oxidizing gas, excessive oxygen content in the headspace of the packaging can trigger oxidative degradation of the active pharmaceutical ingredient, causing critical quality attributes to exceed pharmacopoeia standards and directly affecting the drug's shelf life and safety.

[0003] In the field of injectable drug manufacturing, nitrogen purging is a common industry practice to control headspace residual oxygen levels. Specifically, this involves pre-purging with nitrogen using an independent inflation needle before filling, post-purging with nitrogen after filling, and nitrogen purging before stoppering. This process provides some protection for conventional drugs. However, for highly oxygen-sensitive drugs (such as monoclonal antibodies and peptide formulations), even a small amount of oxygen introduced during the filling process can lead to oxidation of the active pharmaceutical ingredient, thus affecting product quality. Therefore, it is necessary to implement nitrogen purging during the filling process to ensure the stability and efficacy of these highly oxygen-sensitive drugs. Summary of the Invention

[0004] The technical problem this invention aims to solve is to provide an integrated needle sleeve structure that, through a dual-channel design, simultaneously completes drug filling and nitrogen filling. During the filling process, nitrogen protection is provided, and the oxygen in the headspace inside the bottle is directly replaced, keeping the residual oxygen level low. Furthermore, it is compatible with high-precision filling equipment and isolator environments, thus solving a key technical bottleneck in the production of oxygen-sensitive drugs.

[0005] To address the aforementioned problems, this utility model provides a nitrogen-filling needle structure, characterized by comprising two distribution tube assemblies and multiple needles. Each needle has an axially arranged main channel and an outer peripheral channel. The top of the main channel is connected to the liquid inlet, and the outer peripheral channel is connected to the nitrogen inlet on the side. The bottom ends of the main channel and the outer peripheral channel are the liquid outlet and the nitrogen outlet, respectively. Both ends of the distribution tube assembly are media inlets, and multiple media outlets are distributed on the outer periphery.

[0006] Preferably, the medium inlet of one of the distribution tube assemblies is a nitrogen inlet, and the medium outlet of the distribution tube assembly is connected to the nitrogen inlet of the needle; the medium inlet of the other distribution tube assembly is a drug inlet, and the medium outlet of the distribution tube assembly is connected to the drug inlet of the needle.

[0007] Preferably, the nitrogen-filling needle structure further includes a needle holder for fixing the needle to the filling station.

[0008] More preferably, the needle holder is provided with a gripper for limiting the needle, and the gripper has a groove that cooperates with the connecting section on the needle. The upper and lower parts of the connecting section are provided with gripper limiting structures to ensure stable installation of the needle.

[0009] More preferably, the needle holder is provided with countersunk holes for fixing it.

[0010] More preferably, the back of the needle holder is an inclined surface designed to reduce interference with laminar airflow, thereby optimizing the working environment.

[0011] More preferably, the dispensing tube assembly is fixed above the filling station.

[0012] Furthermore, the distribution pipe assembly is fixed by a screw connection.

[0013] Preferably, the medium outlet of the distribution pipe assembly is provided with a nozzle.

[0014] More preferably, the nozzle is threadedly connected to the dispensing tube assembly, and the nozzle is connected to the corresponding port of the needle via a silicone hose.

[0015] The needle of this invention includes two inlets and one outlet. It adopts a dual-channel design: the top inlet connects to the central main channel for drug injection; the side inlet connects to the outer peripheral channel for nitrogen filling; and the outlet at the end of the needle is used to simultaneously inject the drug and nitrogen into the container.

[0016] Compared with existing technologies, the advantages of this invention are as follows: The integrated needle sleeve structure, compared to traditional separate filling needles and nitrogen filling needles, enables simultaneous drug filling and nitrogen purging, significantly shortening the single operation time. It is particularly suitable for high-capacity production lines, effectively improving production efficiency. Simultaneously, the dual-channel isolation design of the needle sleeve prevents the mixing of drug and nitrogen, and the annular nitrogen distribution greatly improves the uniformity of nitrogen purging, thereby significantly improving the control performance of residual oxygen and better ensuring product quality. Furthermore, the middle section of the needle sleeve adopts a reduced-diameter structure, forming a step that facilitates its matching with the needle holder's grippers. This allows the needle tube to be securely clamped onto the needle holder's grippers. The side-insertion method, compared to top insertion, reduces the contact area with the needle holder, effectively avoiding the risk of needle contamination and further ensuring the aseptic nature of the filling process. Attached Figure Description

[0017] Figure 1 This is the front view of the needle;

[0018] Figure 2 for Figure 1 The left view;

[0019] Figure 3 for Figure 2A cross-sectional view of the AA plane;

[0020] Figure 4 This is the front view of the needle holder;

[0021] Figure 5 This is the main view of the distribution pipe component;

[0022] Figure 6 This is one embodiment of the present utility model. Detailed Implementation

[0023] To make this utility model more apparent and understandable, preferred embodiments are described in detail below with reference to the accompanying drawings.

[0024] Example

[0025] like Figure 1 , 2 As shown, the needle sleeve of this invention has a liquid medicine inlet 11, a nitrogen inlet 12, and nested liquid medicine outlets and nitrogen outlets. Both inlets adopt a threaded nozzle design for easy connection with silicone tubing. The cylindrical part of the needle sleeve 1 adopts a diameter reduction structure in the middle section, forming a step. This step matches the clamps of the needle holder 2, allowing the needle sleeve 1 to be securely engaged with the clamps of the needle holder 2.

[0026] like Figure 3 As shown, the cannula 1 adopts a dual-channel design. The top inlet connects to the central main channel 13 for injecting the medication; the side inlet connects to the outer peripheral channel 14 for filling with nitrogen. The outlet at the end of the cannula is used to simultaneously inject the medication and nitrogen into the container. The two channels are completely isolated by a 316L stainless steel partition, effectively avoiding cross-contamination between the medication and nitrogen.

[0027] like Figure 4 As shown, the needle holder 2 has multiple grippers (only 6 are shown in the figure), and each gripper has a groove inside that fits the needles, which can hold 6 needles. The bottom of the needle holder 2 has two countersunk holes for fixed connection with the needle holder moving assembly.

[0028] like Figure 5 The diagram shows the distribution tube assembly, including the distribution tube itself, a media inlet, and a media outlet. Multiple media outlets (only six are shown in the diagram) are located on the outer circumference of the distribution tube wall. Each media outlet has a nozzle with a threaded design, which connects to the nozzle of the needle via a silicone hose to achieve uniform distribution of nitrogen and liquid. Both ends of the media inlet nozzles (air / liquid inlets) have threads; the bottom thread engages with the thread of the distribution tube inlet to ensure a tight connection; the top thread connects to the silicone hose and can be connected to a pumping system for air or liquid inlet.

[0029] like Figure 5The diagram illustrates one embodiment of this invention. The needle 1 is fixed to the gripper of the needle holder 2, and two distribution tube assemblies are fixed above the filling station via screw connections or other supporting structures. During operation, the liquid medicine and nitrogen are delivered to the dual channels of the needle 1 through independent distribution tube assembly 3 connected to distribution tube assembly 4. The medium inlet of distribution tube assembly 3 is the liquid medicine inlet 31, and the medium outlet is the liquid medicine outlet 32. The medium inlet of distribution tube assembly 4 is the nitrogen gas inlet, and the medium outlet is the nitrogen gas outlet. During filling, the liquid medicine is injected into the central main channel 13 through the liquid medicine inlet 11 at the top of the needle 1, and then poured into the container. Simultaneously, nitrogen gas is introduced from the side nitrogen gas inlet 12 and fills the container through the outer peripheral channel 14, forming an inert gas protective layer to prevent oxidation of the liquid medicine.

[0030] As a preferred technical solution, in this embodiment, the cylindrical clamping section of the needle adopts a reduced diameter design in the middle section. The diameter of the reduced diameter section is adapted to the inner diameter of the needle holder jaws, so that the needle tube can be firmly clamped by the jaws.

[0031] As a preferred technical solution, in this embodiment, the needle 1 is installed by inserting into the clamp of the needle holder 2 from the side. Compared with the method of inserting from the top, this reduces the contact area with the needle holder and effectively avoids the risk of needle contamination.

[0032] As a preferred technical solution, in this embodiment, the needle tube of the sheath 1 adopts a dual-channel design. The top inlet connects to the central main channel 13 for drug injection. The side inlet connects to the outer peripheral channel 14 for nitrogen filling. The outlet at the end of the sheath is used to simultaneously inject the drug and nitrogen into the container. The two channels are completely isolated by a 316L stainless steel partition to avoid cross-contamination between the drug and nitrogen.

[0033] As a preferred technical solution, in this embodiment, the middle part of the needle holder 2 is hollowed out and the back is provided with an inclined surface to reduce interference with the laminar flow and optimize the working environment.

Claims

1. A nitrogen-filling sleeve structure, characterized in that, It includes two distribution tube assemblies and multiple needles (1). The needles (1) are provided with a main channel (13) and an outer peripheral channel (14) in the inner axis. The top of the main channel (13) is connected to the liquid inlet (11), and the outer peripheral channel (14) is connected to the nitrogen inlet (12) on the side. The bottom ends of the main channel (13) and the outer peripheral channel (14) are the liquid outlet and the nitrogen outlet, respectively. The two ends of the distribution tube assembly are medium inlets, and multiple medium outlets are distributed on the outer periphery.

2. The filling and nitrogen-filling needle structure as described in claim 1, characterized in that, One of the distribution tube assemblies has a nitrogen inlet at its media inlet and its media outlet is connected to the nitrogen inlet (12) of the needle (1); the other distribution tube assembly has a liquid medicine inlet at its media inlet and its media outlet is connected to the liquid medicine inlet (11) of the needle (1).

3. The filling and nitrogen-filling needle structure as described in claim 1, characterized in that, It also includes a needle holder (2) for securing the needle (1) to the filling station.

4. The filling and nitrogen-filling needle structure as described in claim 3, characterized in that, The needle holder (2) is provided with a gripper for limiting the sleeve needle (1). The gripper has a groove that matches the connecting section on the sleeve needle (1). The upper and lower parts of the connecting section are provided with gripper limiting structures.

5. The filling and nitrogen-filling needle structure as described in claim 3, characterized in that, The needle holder (2) is provided with countersunk holes for fixing it.

6. The filling and nitrogen-filling needle structure as described in claim 3, characterized in that, The back of the needle holder (2) is an inclined surface designed to reduce interference with laminar airflow.

7. The filling and nitrogen-filling needle structure as described in claim 3, characterized in that, The distribution tube assembly is fixed above the filling station.

8. The filling and nitrogen-filling needle structure as described in claim 5, characterized in that, The distribution pipe assembly is fixed by a screw connection.

9. The filling and nitrogen-filling needle structure as described in claim 1, characterized in that, The medium outlet of the distribution pipe assembly is equipped with a nozzle.

10. The filling and nitrogen-filling needle structure as described in claim 9, characterized in that, The nozzle is threadedly connected to the distribution tube assembly, and the nozzle is connected to the corresponding port of the sleeve (1) through a silicone hose.

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