Syringe assembly

Abstract

The utility model discloses a syringe assembly, syringe assembly includes integral needle tube, and the inside of integral needle tube forms and forms the closed pipe section and the lead -through pipe section with the needle tube inner wall of injection cavity, and the middle part piston and bottom piston, and the middle part piston sets up in the injection cavity and with injection cavity front part cavity between define first cavity, and bottom piston sets up in the bottom of injection cavity and with middle part piston between define second cavity, and form the inner runner with the lead -through pipe section in the closed pipe section, and bottom piston moves towards middle part piston optionally, and middle part piston moves to the position of cooperation with lead -through pipe section from the cooperation position with closed pipe section under the pressure effect. First cavity and second cavity respectively pre -fill in the mixture of waiting, and utilize bottom piston and the linkage of middle part piston realize accurate mixing, and the second cavity of complete emptying makes excess filling amount reduce significantly, and the closed mixing mechanism effectively prevents the risk of outside pollution.

Description

Technical Field

[0001] This invention relates to the field of syringes, and more particularly to a syringe assembly. Background Technology

[0002] In related technologies, syringes are used to store various liquids or agents containing different active ingredients or components. These drugs are typically dispensed into two or more different containers and transferred to a single syringe before injection, where they are thoroughly mixed. This process carries risks of particulate contamination and microbial contamination. Furthermore, to offset dosage loss during transfer, overfilling is often necessary, increasing costs. Summary of the Invention

[0003] This invention aims to at least solve one of the technical problems existing in the prior art. To this end, one object of this invention is to propose a syringe assembly with two chambers, a first chamber and a second chamber, respectively for containing different mixtures to be mixed. The first chamber and the second chamber are pre-filled with the mixtures to be mixed. Precise mixing is achieved by the linkage of the bottom piston and the middle piston. The second chamber can be completely emptied, which significantly reduces the amount of overfilling. The closed mixing mechanism effectively eliminates the risk of external contamination.

[0004] In one embodiment of this application, the syringe assembly includes: an integral needle tube having an injection chamber formed inside, the inner wall of the injection chamber having a closed section and a through section; a middle piston and a bottom piston, the middle piston being disposed within the injection chamber and defining a first cavity between it and a front cavity of the injection chamber, the bottom piston being disposed at the bottom of the injection chamber and defining a second cavity between it and the middle piston, the first cavity and the second cavity being respectively used to accommodate two different mixtures to be mixed; an inner flow channel being formed in the through section, the middle piston being movable within the integral needle tube to selectively move to engage with the through section or with the closed section; wherein the bottom piston is selectively movable toward the middle piston, the middle piston being moved under pressure from a position engaging with the closed section to a position engaging with the through section, and when the middle piston moves to the through section, the bottom piston approaches the middle piston, causing the volume of the second cavity to gradually decrease.

[0005] By setting a middle piston and a bottom piston, and under the action of the inner flow channel, the mixture to be mixed in the first chamber and the second chamber can be completely mixed. The two different mixtures can correspond to the drug and the solvent respectively. On the one hand, it reduces contamination during the mixing process. On the other hand, the syringe of this application does not need to carry excessive solvent, and the dosage control of the solvent is more precise. After the bottom piston and the middle piston stop, the medium to be mixed in the second chamber will completely enter the first chamber through the inner flow channel. In large-volume drug production, reducing the excessive filling dosage of a single syringe assembly can reduce the overall cost and reduce unnecessary waste.

[0006] In some embodiments of this application, a first stop surface is formed at the bottom of the middle piston, and a second stop surface is formed at the top of the bottom piston. The bottom piston moves toward the middle piston and keeps the first stop surface in face-to-face contact with the second stop surface to stop and guide the medium in the second cavity into the first cavity.

[0007] In some embodiments of this application, the first stop surface and the second stop surface are constructed as flat wall surfaces perpendicular to the extension direction of the injection cavity.

[0008] In some embodiments of this application, at least one of the first stop surface and the second stop surface has an end face protrusion.

[0009] In some embodiments of this application, the outer peripheral walls of the middle piston and the bottom piston are respectively formed with protruding waterproof lines.

[0010] In some embodiments of this application, the syringe assembly further includes a piston rod, the end of which is connected to the bottom piston and adapted to push the bottom piston toward a direction close to the middle piston.

[0011] In some embodiments of this application, the end of the piston rod is formed with a connecting column section, the outer surface of the connecting column section is formed with external threads, and the bottom of the bottom piston is formed with a recessed mating hole section, the mating hole section being adapted to receive the connecting column section and having internal threads formed on its inner surface.

[0012] In some embodiments of this application, the inner flow channel is configured as a groove formed on the inner wall of the guide pipe section, the groove extending along the movement direction of the central piston, and the groove having a width extending circumferentially in the guide pipe section.

[0013] In some embodiments of this application, the grooves are configured as a plurality of grooves spaced apart circumferentially on the inner wall of the conductive pipe section.

[0014] In some embodiments of this application, the end of the integrated needle tube is formed with a Luer cone, a drug delivery channel communicating with the injection cavity is formed inside the Luer cone, and a fitting sleeve is formed around the outer periphery of the Luer cone at the end of the integrated needle tube, and a Luer lock thread is formed on the inner surface of the fitting sleeve.

[0015] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0016] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which:

[0017] Figure 1 This is a schematic diagram of the syringe assembly according to an embodiment of this application.

[0018] Figure 2 This is a schematic diagram of the integrated needle tube of the syringe assembly according to an embodiment of this application;

[0019] Figure 3 This is a schematic diagram of the structure of the central piston of the syringe assembly according to an embodiment of this application;

[0020] Figure 4 This is a schematic diagram of the bottom piston of the syringe assembly according to an embodiment of this application;

[0021] Figure 5 This is a schematic diagram of the piston rod of the syringe assembly according to an embodiment of this application;

[0022] Figure 6 This is a schematic diagram illustrating the use of a syringe assembly according to an embodiment of this application.

[0023] Figure label:

[0024] Syringe assembly 100

[0025] Integrated needle tube 1

[0026] Needle outer wall 101, needle inner wall 102, inner flow channel 103, bottom flange 104, Luer lock thread 105, Luer taper 106, drug dispensing channel 107.

[0027] 2. Middle piston, 201. First waterproof line, 202. End face protrusion.

[0028] Bottom piston 3, second waterproof line 301, internal thread 302, end face boss 303

[0029] Piston push rod 4, flange 401, rod body 402, external thread 403, reinforcing rib 404.

[0030] 5. Luer lock cap, 6. First component, 7. Second component, 8. Mixed medicine solution. Detailed Implementation

[0031] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0032] The following is for reference. Figures 1-6 A syringe assembly 100 according to an embodiment of the present invention is described.

[0033] The syringe assembly 100 according to this application includes an integral needle tube 1, a middle piston 2, and a bottom piston 3. An injection chamber is formed inside the integral needle tube 1. The inner wall 102 of the injection chamber has a closed section and a through section. The middle piston 2 is disposed within the injection chamber and defines a first cavity between itself and the front cavity of the injection chamber. The bottom piston 3 is disposed at the bottom of the injection chamber and defines a second cavity between itself and the middle piston 2. The first and second cavities are respectively used to accommodate two different mixtures to be prepared. By placing the two different mixtures to be prepared in the first and second cavities, the drug can be effectively preserved.

[0034] An inner flow channel 103 is formed in the conductive tube section. The middle piston 2 moves within the integrated needle tube 1 to selectively move to cooperate with the conductive tube section or with the closed tube section. The bottom piston 3 can selectively move toward the middle piston 2. The pressure of the bottom piston 3 pushes the middle piston 2 from the closed tube section to the conductive tube section. When the middle piston 2 moves to the conductive tube section, the bottom piston 3 approaches the middle piston 2, causing the volume of the second cavity to gradually decrease.

[0035] In this application, in the initial state, the middle piston 2 is in contact with the closed tube section, and the first cavity and the second cavity remain sealed. During the process of pushing the bottom piston 3, since the second cavity remains closed, the pressure is transmitted to the middle piston 2 through the action of air pressure or hydraulic pressure to drive the middle piston 2 to move, so that the middle piston 2 cooperates with the connecting tube section, thereby using the internal flow channel 103 provided on the connecting tube section to connect the first cavity and the second cavity. The two different mixtures located in the first cavity and the second cavity are fully mixed to form a prepared drug for injection.

[0036] After the middle piston 2 moves to the connecting tube section, the pressure inside the second chamber changes because it is connected to the first chamber through the internal flow channel 103. Under the continuous action of the bottom piston 3, the volume of the second chamber gradually decreases until the bottom piston 3 and the middle piston 2 come into contact, thus completely mixing the media in the first and second chambers. Further pushing the bottom piston 3 will drive the middle piston 2 to move, allowing the mixed drug in the first chamber to be pushed and injected.

[0037] In this application, by setting the middle piston 2 and the bottom piston 3, and under the action of the inner flow channel 103, the mixture to be mixed in the first chamber and the second chamber can be completely mixed. The two different mixtures can correspond to the drug and the solvent respectively. On the one hand, it reduces the contamination during the mixing process. On the other hand, the syringe of this application does not need to carry excessive solvent, and the dosage control of the solvent is more precise. After the bottom piston 3 and the middle piston 2 stop, more of the medium to be mixed in the second chamber will enter the first chamber through the inner flow channel 103, thereby reducing the excessive filling dosage of a single syringe assembly 100, which can reduce the overall cost and reduce unnecessary waste.

[0038] According to some embodiments of this application, a first stop surface is formed at the bottom of the middle piston 2, and a second stop surface is formed at the top of the bottom piston 3. The bottom piston 3 moves toward the middle piston 2 until the first stop surface contacts the second stop surface, thus introducing the medium from the second cavity into the first cavity. The bottom of the middle piston 2 and the top of the bottom piston 3 are respectively provided with a first stop surface and a second stop surface. The stop surface between the first stop surface and the second stop surface compresses all the agent in the second cavity into the first cavity, thereby discharging all the mixture to be mixed in the first and second cavities, further improving the accuracy of agent control.

[0039] In some embodiments, the face-to-face contact between the first stop surface and the second stop surface can be understood as complete contact between the first stop surface and the second stop surface, reducing the space of the second cavity to a state with almost no space, thereby squeezing the mixture to be mixed in the second cavity into the first cavity. Through the face-to-face contact between the first stop surface and the second stop surface, the mixture to be mixed in the second cavity can be fully introduced into the first cavity. Therefore, the syringe assembly 100 of this application greatly reduces the overfilling dosage of the mixture to be mixed in the second cavity, thereby reducing the cost.

[0040] In some embodiments of this application, the first and second abutment surfaces are constructed as flat walls perpendicular to the extension direction of the injection cavity. Setting the first and second abutment surfaces as flat walls allows for sufficient contact between them, reducing the gap between them after abutment, minimizing the residual amount of the mixture in the second cavity, and helping to reduce the amount of overfilled drug. Simultaneously, constructing the first and second abutment surfaces as flat walls effectively pushes the drug in the second cavity, ensuring effective pressure transmission, allowing the central piston 2 to be fully compressed and move from the position cooperating with the closed section to the position cooperating with the open section.

[0041] According to some embodiments of this application, at least one of the first stop surface and the second stop surface is provided with an end face protrusion 202. The end face protrusion 202 provided between the first stop surface and the second stop surface can prevent the middle piston 2 and the bottom piston 3 from sticking together during the manufacturing process.

[0042] In some embodiments of this application, the middle piston 2 and the bottom piston 3 are constructed as flexible members, and end face protrusions 202 are provided on at least one of the first stop surface and the second stop surface, which can help to provide a better sealing effect after they come into contact with each other.

[0043] In some other embodiments of this application, the first stop surface and the second stop surface may also be constructed as conical surfaces or curved surfaces with exactly the same shape and angle.

[0044] According to some embodiments of this application, the outer peripheral walls of the middle piston 2 and the bottom piston 3 are respectively formed with protruding waterproof lines. These waterproof lines can contact the wall of the injection chamber to maintain a seal between the middle piston 2 and the injection chamber, ensuring that the first chamber does not leak when the middle piston 2 engages with the closed tubing section, thus ensuring a reliable seal between the first and second chambers and preventing drug deterioration; they also ensure a seal between the bottom piston 3 and the injection chamber, allowing the bottom piston 3 to effectively seal the second chamber, while reducing leakage during the pushing of the bottom piston 3, ensuring reliable pressure transmission to the middle piston 2, and improving the reliability of the syringe assembly 100.

[0045] In some embodiments of this application, the waterproof line can be configured as an annular first waterproof line 201 surrounding the outer periphery of the central piston 2, and the first waterproof line 201 can be configured as a plurality of spaced apart in the axial direction; the waterproof line can be configured as an annular second waterproof line 301 surrounding the outer periphery of the bottom piston 3, and the second waterproof line 301 can be configured as a plurality of spaced apart in the axial direction.

[0046] In some embodiments of this application, the syringe assembly 100 further includes a piston rod 4, one end of which is connected to the bottom piston 3 and adapted to push the bottom piston 3 toward the central piston 2. The other end of the piston rod 4 extends out of the injection chamber, and the length of the piston rod 4 can be set slightly longer than the length of the injection chamber, so that when pushing the bottom piston 3, the piston rod 4 can completely push the bottom piston 3 to the front end of the injection chamber.

[0047] In some embodiments of this application, the bottom piston 3 is provided with an end face boss 303 on the side opposite to the middle piston 2. The end face boss 303 is used to improve the strength of the connecting piston push rod 4.

[0048] In some embodiments, the end of the piston rod 4 is formed with a connecting column section, the outer surface of the connecting column section is formed with an external thread 403, and the bottom of the bottom piston 3 is formed with a recessed mating hole section, the mating hole section is adapted to receive the connecting column section and the inner surface is formed with an internal thread 302.

[0049] In some embodiments of this application, the piston push rod 4 includes a flange 401, a rod body 402, an external thread 403, and a reinforcing rib 404. The end of the rod body 402 is provided with a connecting column section, and the bottom of the rod body 402 is provided with a flange 401, which increases the area of ​​the pushing end of the piston push rod 4 to facilitate pushing. Multiple reinforcing members 404 are provided on the surface of the rod body 402. The reinforcing members 404 may protrude in the extension direction of the rod body 402 or protrude in the circumferential direction of the rod body 402.

[0050] In some embodiments of this application, the inner flow channel 103 is constructed as a groove formed on the inner wall of the guide tube section. The groove extends along the moving direction of the central piston 2 and has a width extending circumferentially in the guide tube section. The groove formed on the inner wall of the guide tube section ensures that the outer wall 101 of the integrated needle tube 1 does not change in shape, facilitating transportation and use. When the central piston 2 moves to the position where the groove is provided, a passage is formed between the outer peripheral wall of the central piston 2 and the groove to connect the first cavity and the second cavity, allowing the first cavity to communicate with the second cavity. Under pressure, the liquid in the second cavity enters the first cavity through this passage to complete mixing.

[0051] In some embodiments of this application, the grooves are configured as multiple grooves spaced apart circumferentially on the inner wall of the conductive pipe section. By providing multiple grooves, the flow rate of the passage between the first cavity and the second cavity can be increased, thereby accelerating the mixing speed.

[0052] In some embodiments of this application, the end of the integrated needle tube 1 is formed with a Luer cone 106, and a drug delivery channel 107 communicating with the injection cavity is formed inside the Luer cone 106. The end of the integrated needle tube 1 is formed with a mating sleeve surrounding the outer periphery of the Luer cone 106, and a Luer lock thread 105 is formed on the inner surface of the mating sleeve.

[0053] In some embodiments of this application, the bottom of the integrated needle tube 1 is provided with a bottom flange 104, which protrudes radially from the outer wall 101 of the needle tube of the integrated needle tube 1.

[0054] The arrangement of the Luer cone 106 and the fitting sleeve allows the syringe assembly 100 to engage with either the injection needle or the Luer lock cap. During filling and lyophilization, the syringe assembly 100 engages with the Luer lock cap, which can selectively open or close the first chamber to the outside environment to meet the lyophilization requirements of the drug within the first chamber. When injection is required, the Luer lock cap is removed, and the injection needle locks with the Luer cone 106 and the fitting sleeve to facilitate drug delivery and injection.

[0055] like Figure 6 As shown, when using the syringe assembly 100 of this application, the Luer lock cap 5 is unscrewed and removed, and the injection needle is installed through the Luer lock thread 105. Then, the piston rod 4 is installed. The piston rod 4 is pushed by the engagement of its external thread 403 and the internal thread 302 of the bottom piston 3, pushing all of the first component 6 from the cavity away from the drug outlet into the cavity near the drug outlet, where it is thoroughly mixed with the second component 7 to form a mixed drug solution 8. The piston rod 4 is pushed again to expel the gas from the cavity near the drug outlet, preparing for injection. The first component 6 is a liquid, and the second component 7 can be either a liquid or a solid; the first component 6 and the second component 7 are the two different mixtures mentioned above.

[0056] In one specific embodiment of this application, the material of the integrated needle tube 1 may be borosilicate glass, polypropylene, polyethylene, polystyrene, polycarbonate, polymethyl methacrylate, cyclic olefin copolymers, cyclic olefin polymers, and cyclic olefin block polymers. Preferably, the material of the integrated needle tube 1 is a cyclic olefin copolymer or a cyclic olefin polymer. The inner flow channel 103 of the Luer lock dual-lumen needle tube has a locally recessed feature on the inner wall. The corresponding position on the outer wall 101 of the needle tube should be smooth and flat or have locally protruding. The locally protruding can form an inner flow channel 103 on the corresponding inner wall 102 of the needle tube. The number of inner flow channels 103 is one or more. In some specific embodiments, the number of inner flow channels 103 is two.

[0057] The middle piston 2 and the bottom piston 3 can be made of polyisoprene, brominated butyl rubber, chlorinated butyl rubber, fluororubber, and thermoplastic elastomers, with a hardness range of 20–80 HA. In some specific embodiments, the bottom piston 3 and the middle piston 2 are made of chlorinated butyl or brominated butyl rubber, with a hardness range of 35–55 HA. The internal thread 302 of the bottom piston 3 matches the external thread of the bottom piston 3 push rod. In some specific embodiments, the middle piston 2 should be symmetrically arranged about the central waterproof line.

[0058] The piston push rod 4 can be made of polypropylene, polyethylene, polystyrene, polycarbonate, polymethyl methacrylate, acrylonitrile-butadiene-styrene copolymer, or acrylic-butadiene-styrene copolymer. The internal thread 302 of the bottom piston 3 matches the external thread of the piston push rod 4.

[0059] According to the syringe assembly 100 of this application, the storage, mixing and injection of multi-active ingredient drugs can be completed using only a single syringe, which greatly simplifies the injection operation process of multi-active ingredient drugs. The closed system ensures a sterile environment and controls the overfilling dosage to a low level, thereby reducing costs.

[0060] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention 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 invention.

[0061] In the description of this invention, "first feature" and "second feature" may include one or more of the features.

[0062] In the description of this invention, "a plurality of" means two or more.

[0063] In the description of this invention, the first feature being "above" or "below" the second feature may include the first and second features being in direct contact, or it may include the first and second features not being in direct contact but being in contact through another feature between them.

[0064] In the description of this invention, the terms "above," "over," and "on top" for the first feature and the second feature include the first feature being directly above or diagonally above the second feature, or simply indicating that the first feature is at a higher horizontal level than the second feature.

[0065] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0066] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A syringe assembly comprising: include: An integrated needle tube, wherein an injection cavity is formed inside the integrated needle tube, and a closed tube section and a conductive tube section are formed on the inner wall of the injection cavity needle tube; The middle piston and the bottom piston are provided. The middle piston is disposed in the injection chamber and defines a first cavity between the middle piston and the front cavity of the injection chamber. The bottom piston is disposed at the bottom of the injection chamber and defines a second cavity between the middle piston. The first cavity and the second cavity are respectively used to accommodate two different mixtures to be mixed. An internal flow channel is formed in the conductive tube section, and the central piston moves within the integral needle tube to selectively engage with the conductive tube section or with the closed tube section; wherein The bottom piston can selectively move toward the middle piston. The middle piston is moved by pressure from a position that engages with the closed pipe section to a position that engages with the open pipe section. When the middle piston moves to the open pipe section, the bottom piston moves closer to the middle piston, causing the volume of the second cavity to gradually decrease.

2. The syringe assembly of claim 1, wherein, The bottom of the middle piston has a first stop surface, and the top of the bottom piston has a second stop surface. The bottom piston moves toward the middle piston and keeps the first stop surface and the second stop surface in face-to-face contact to stop and guide the medium in the second cavity into the first cavity.

3. The syringe assembly of claim 2, wherein, The first stop surface and the second stop surface are constructed as flat wall surfaces perpendicular to the extension direction of the injection cavity.

4. The syringe assembly of claim 3, wherein, At least one of the first stop surface and the second stop surface has an end face protrusion.

5. The syringe assembly according to claim 3, characterized in that, The outer peripheral walls of the middle piston and the bottom piston are respectively formed with protruding waterproof lines.

6. The syringe assembly of claim 1, wherein, Also includes: A piston push rod, the end of which is connected to the bottom piston and adapted to push the bottom piston toward a direction closer to the middle piston.

7. The syringe assembly of claim 6, wherein, The piston rod has a connecting column section at its end, and the outer surface of the connecting column section has an external thread. The bottom of the bottom piston has a recessed mating hole section, which is adapted to receive the connecting column section and has an internal thread on its inner surface.

8. The syringe assembly of claim 1, wherein, The inner flow channel is constructed as a groove formed on the inner wall of the guide pipe section, the groove extending along the movement direction of the central piston, and the groove having a width extending circumferentially in the guide pipe section.

9. The syringe assembly of claim 8, wherein, The grooves are constructed by arranging multiple grooves at intervals along the circumference of the inner wall of the conductive pipe section.

10. The syringe assembly of claim 1, wherein, The end of the integrated needle tube is formed with a Luer cone, and a drug delivery channel communicating with the injection cavity is formed inside the Luer cone. The end of the integrated needle tube is formed with a fitting sleeve around the outer periphery of the Luer cone, and the inner surface of the fitting sleeve is formed with Luer locking threads.

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