A powder and solvent dual-chamber pre-filled ready-to-use injection device and method

Abstract

The present invention relates to a powder and solvent double-chamber pre-filled ready-to-use injection device and method, comprising a powder syringe, a needle is provided at the end of the powder syringe, a liquid syringe is inserted into the powder syringe, the liquid syringe can move along the axial direction of the powder syringe, a first rubber plug tightly fitted with the inner cylinder surface of the powder syringe is fixed to the end of the liquid syringe inserted into the powder syringe, a first push rod is inserted into the liquid syringe, a second rubber plug tightly fitted with the inner cylinder surface of the liquid syringe is fixed to the end of the first push rod, the first push rod passes through the second push rod, both the first rubber plug and the second rubber plug are provided with an opening for the second push rod to pass through, and the hole surface of the opening can be tightly fitted with the second push rod. The injection device of the present invention takes short time and is not easy to be contaminated by drugs.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a powder and solvent double-chamber pre-filled ready-to-use injection device and method. Background Art

[0002] The statements herein merely provide background information related to the present invention and do not necessarily constitute prior art.

[0003] Solution-type prefilled syringes are mainly composed of a needle tube, a push rod, a rubber piston, an injection needle or a cone head, and a protective cap. The manufacturer prepares the active or functional ingredients into a solution, and then directly loads it into the syringe and stores it under the required temperature and other storage conditions. When using it, you can directly remove the protective cap, and then perform injection, flushing and other operations directly according to the instructions for use, which is simple and convenient. All parts of the syringe must have good sealing properties; have good compatibility with the packaged solution, that is, it does not affect the function and stability of the active or functional components of the solution; and the impurity leaching must meet the requirements of national standards.

[0004] Compared with similar products in the early stage of the powder solution being separated and dissolved during use, the solution-type prefilled syringe has the following advantages: 1. Convenient and safe for clinical use by medical staff: high operating efficiency, significant time saving; preset dosage, not easy to mismatch solution dosage and easy and accurate use of liquid to reduce waste; no preparation process, reducing the chance of microbial contamination; clear labeling, not easy to confuse drug categories, can reduce the occurrence of potential medical accidents, etc.; 2. The manufacturing process is simplified, after the functional ingredients are dissolved, sterilized, and filled into the sterilized prefilled syringe, the two are combined into one, eliminating the need for manufacturers to package powder drugs and solvents separately.

[0005] Although solution-type prefilled syringes have many advantages, the premise is that the activity or function in the solution must be stable. For some drugs or products containing unstable components in the solution, the above-mentioned solution-type prefilled syringes are still useless. For such drugs or products, a more traditional manufacturing method is required: that is, the drug or product powder is packaged separately in a container such as a vial, and the solvent is packaged in another container. When in use, the solution is first extracted with a syringe, then added to the powder bottle, mixed and then absorbed. The inventors found that the products packaged in vials have the following disadvantages when used: 1. The operation of medical staff takes a long time, is easy to contaminate, and the probability of error increases; 2. After the needle pierces the rubber pad, especially when the powder and solution packaging need to be pierced twice, it is easy to become blunt or burred, which will increase the pain when piercing the human body, and the needle may contain rubber components, which may cause allergies in sensitive individuals. Summary of the invention

[0006] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a powder and solvent double-chamber pre-filled ready-to-use injection device, which is time-saving to operate and not prone to contamination.

[0007] To achieve the above object, the present invention adopts the following technical solutions:

[0008] In the first aspect, the present invention provides a powder and solvent dual-chamber pre-filled ready-to-use injection device, comprising a powder syringe, a needle is provided at the end of the powder syringe, a liquid syringe is inserted into the powder syringe, the liquid syringe can move along the axial direction of the powder syringe, a first rubber plug tightly fitting the inner cylinder surface of the powder syringe is fixed to the end of the liquid syringe inserted into the powder syringe, a first push rod is inserted into the liquid syringe, a second rubber plug tightly fitting the inner cylinder surface of the liquid syringe is fixed to the end of the first push rod, the first push rod passes through the second push rod, both the first rubber plug and the second rubber plug are provided with an opening for the second push rod to pass through, and the hole surface of the opening can be tightly fitted with the second push rod.

[0009] In the second aspect, the present invention provides a powder and solvent dual-chamber pre-filled ready-to-use injection device, comprising a powder syringe, a needle is provided at the end of the powder syringe, a liquid syringe is inserted into the powder syringe, the liquid syringe can move along the axial direction of the powder syringe, a first rubber plug tightly fitting with the inner cylinder surface of the powder syringe is fixed to the end of the liquid syringe inserted into the powder syringe, a first push rod is inserted into the inside of the liquid syringe, a second rubber plug tightly fitting with the inner cylinder surface of the liquid syringe is fixed to the end of the first push rod, the first rubber plug is provided with an opening, and a one-way valve is installed at the opening.

[0010] Furthermore, the first rubber plug includes a sealing portion and a connecting portion, the outer peripheral surface of the sealing portion is tightly fitted with the inner cylinder surface of the powder syringe, and the connecting portion is fixedly connected to the end of the liquid syringe.

[0011] Furthermore, the connecting portion is inserted into the liquid medication syringe and fixed to the liquid medication syringe by being squeezed or bonded.

[0012] Furthermore, the outer peripheral surface of the connecting part is provided with a plurality of clamping grooves, the inner cylinder surface of the end of the liquid medication syringe is provided with a plurality of clamping rings, the clamping rings are clamped into the clamping grooves, and the connecting part is clamped and fixed to the liquid medication syringe through the clamping grooves and the clamping rings.

[0013] Furthermore, a connecting tube is provided at the end of the liquid preparation syringe, and the first rubber plug is sleeved and fixed on the outer periphery of the connecting tube.

[0014] Furthermore, the connecting tube is fixed to the first rubber plug by pasting or a plurality of clamping rings are provided on the outer circumference of the connecting tube, and the connecting tube is clamped and fixed to the first rubber plug through the clamping rings and the clamping grooves provided in the first rubber plug.

[0015] Furthermore, the second rubber plug sleeve is disposed on the outer periphery of the end of the first push rod and is fixedly connected to the first push rod.

[0016] Furthermore, it also includes a cap that can be detachably fixedly connected to the end of the powder syringe where the needle is arranged, a third rubber plug is fixed inside the cap, and the needle can be inserted into the third rubber plug.

[0017] In a third aspect, the present invention provides a working method of a powder and solvent dual-chamber pre-filled ready-to-use injection device, comprising the following steps:

[0018] Preliminarily placing a solvent in the liquid preparation syringe, placing powder in the powder preparation syringe, and sealing the opening of the first rubber plug;

[0019] The opening of the first rubber stopper is opened, and the first push rod is operated to push the solvent in the liquid syringe into the powder syringe through the opening of the first rubber stopper, so that the powder and the solvent are mixed;

[0020] After the powder and the solvent are evenly mixed to form a mixed medicine, the opening of the first rubber plug is sealed, and the first push rod continues to push. After the second rubber plug contacts the first rubber plug, the first push rod drives the first rubber plug and the second rubber plug to move together, pushing the mixed medicine to be ejected through the needle.

[0021] Beneficial effects of the present invention:

[0022] 1. In the injection device of the present invention, the powder and the solvent are pre-stored in the powder syringe and the solvent syringe. During use, only the first push rod needs to be pushed to complete the mixing operation and injection operation of the solvent and the powder. The operation is simple and time-saving. Moreover, the solvent and the powder are both located in a closed space and will not cause contamination to the drug.

[0023] 2. Compared with the traditional syringe, the injection device of the present invention does not need to be packaged for powder and solution with two punctures, thus avoiding the needle from becoming blunt or burred, reducing the pain when the needle pierces the human body, and avoiding the phenomenon of allergies in sensitive individuals caused by the rubber component on the needle. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The drawings in the specification, which constitute a part of the present application, are used to provide a further understanding of the present application. The illustrative embodiments of the present application and their descriptions are used to explain the present application and do not constitute a limitation on the present application.

[0025] Figure 1 The overall structure of Example 1 of the present invention is shown in FIG. Figure 1 ;

[0026] Figure 2 The overall structure of Example 1 of the present invention is shown in FIG. Figure 2 ;

[0027] Figure 3 This is a schematic diagram of the overall structure of Embodiment 3 of the present invention;

[0028] Figure 4 This is a flowchart of the fourth embodiment of the present invention;

[0029] Among them, 1. powder syringe, 2. liquid outlet tube, 3. needle, 4. liquid syringe, 5. first rubber plug, 5-1. sealing part, 5-2. connecting part, 6. connecting tube, 7. hollow cylindrical rod, 8. wing plate, 9. second rubber plug, 10. second push rod, 11. cover cap, 12. third rubber plug, 13. powder, 14. solvent, 15. mixed drug, 16. silicone one-way valve. DETAILED DESCRIPTION

[0030] It should be noted that the following detailed descriptions are exemplary and are intended to provide further explanation of the present application. Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those commonly understood by those skilled in the art to which the present application belongs.

[0031] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0032] For the convenience of description, if the words "up", "down", "left" and "right" appear in the present invention, they only indicate that they are consistent with the up, down, left and right directions of the drawings themselves, and do not limit the structure. They are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it cannot be understood as a limitation on the present invention.

[0033] As described in the background art, the existing prefilled syringes are time-consuming and easily contaminated when used for drugs or products containing unstable components in the solution. To address the above problems, the present application proposes a powder and solvent dual-chamber prefilled ready-to-use injection device.

[0034] In a typical implementation example 1 of the present application, Figure 1 As shown, a powder and solvent dual-chamber pre-filled ready-to-use injection device comprises a powder syringe 1 for pre-filling powder, the powder syringe adopts a cylindrical tubular structure with an inner diameter of 5-50mm, one end of the powder syringe is open, preferably, the powder syringe is made of glass or plastic material, and has excellent leaching performance, a liquid outlet pipe 2 is arranged at the center of the other end of the powder syringe, the liquid outlet pipe is connected to the internal space of the powder syringe, the inner diameter of the liquid outlet pipe is 0.5-5mm, the liquid outlet pipe is connected to a needle 3, the solution in the powder syringe can be ejected through the needle, the connection method of the liquid outlet pipe and the needle can adopt the connection method of the liquid outlet pipe and the needle of the existing syringe, which will not be described in detail here.

[0035] The open end of the powder syringe is inserted with a liquid syringe 4, which is coaxially arranged with the powder syringe. The liquid syringe is used to hold a solvent. The liquid syringe is a cylindrical tubular structure with an inner diameter of 4.5-49 mm. The liquid syringe can move along its own axis relative to the powder syringe.

[0036] The end of the liquid syringe extending into the powder syringe is detachably fixed with a first rubber plug 5, the outer peripheral surface of the first rubber plug is tightly fitted with the inner tube surface of the powder syringe, and the central part of the first rubber plug is provided with an opening for the solvent in the liquid syringe to enter the interior of the powder syringe.

[0037] The first rubber plug is made of a flexible material. Preferably, the first rubber plug is made of a halogenated butyl rubber material.

[0038] The first rubber plug includes a sealing portion 5-1 and a connecting portion 5-2. The sealing portion is located outside the liquid medication syringe, and its outer diameter is larger than the outer diameter of the liquid medication syringe. The outer peripheral surface of the sealing portion is tightly fitted with the inner cylinder surface of the powder syringe. The connecting portion is inserted into the liquid medication syringe, and the outer diameter of the connecting portion is slightly larger than the inner diameter of the liquid medication syringe, so that the connecting portion can be squeezed and fixed with the liquid medication syringe, thereby realizing a detachable fixed connection between the first rubber plug and the liquid medication syringe.

[0039] In another embodiment, the connecting portion is inserted into the interior of the powder syringe and is detachably fixedly connected to the inner cylinder surface of the powder syringe by gluing and fixing.

[0040] In the third embodiment, 1-3 clamping rings are arranged on the inner cylinder surface of the end of the liquid medication syringe, and a clamping groove matching the clamping ring is arranged on the connecting part, and the clamping ring is inserted into the clamping groove to achieve the fixation of the connecting part and the liquid medication syringe. It can be understood that a clamping groove can also be arranged on the inner cylinder surface of the liquid medication syringe, and a clamping ring can be arranged on the connecting part to achieve the connection between the connecting part and the liquid medication syringe.

[0041] like Figure 2 As shown, in the fourth embodiment, a connecting tube 6 is provided at the end of the liquid syringe inserted into the powder syringe, the diameter of the connecting tube is smaller than the diameter of the liquid syringe and is communicated with the internal space of the liquid syringe, the first rubber plug is fixed on the connecting tube by means of an open hole sleeve and is glued and fixed to the connecting tube, or 1-3 clamping rings are provided on the connecting tube, the first rubber plug is provided with a clamping groove matching the clamping ring, and the connecting tube is fixedly connected to the first rubber plug through the clamping ring and the clamping groove.

[0042] The other end of the liquid syringe is open and has a first push rod coaxially inserted therein. The first push rod is a hollow cylindrical rod or includes a hollow cylindrical rod 7. A plurality of wing plates 8 are arranged on the cylindrical surface of the hollow cylindrical rod. The plurality of wing plates are evenly distributed along the circumference. Preferably, three wing plates are arranged.

[0043] The end of the first push rod inserted into the liquid syringe is provided with a second rubber plug 9, the outer peripheral surface of the second rubber plug is tightly fitted with the inner cylinder surface of the liquid syringe, and the second rubber plug is made of a flexible material. Preferably, the second rubber plug is made of halogenated butyl rubber.

[0044] The end of the second rubber plug is sleeved on the outer circumference of the first push rod and is bonded and fixed to the first push rod. In another embodiment, a plurality of slots are provided on the second rubber plug, and the wing plate is inserted into the slots to fix the second rubber plug to the first push rod.

[0045] An opening is provided at the center of the second rubber plug, a second push rod 10 passes through the internal cavity of the first push rod, the second push rod passes through the opening of the second rubber plug and is inserted into the opening of the first rubber plug. The second push rod is a solid rod, and its outer diameter is slightly larger than the diameter of the openings provided in the first rubber plug and the second rubber plug, so that it can seal the openings of the first rubber plug and the second rubber plug.

[0046] Preferably, the length of the second push rod is approximately equal to the sum of the length of the first push rod and the length of the liquid syringe.

[0047] The powder and solvent dual-chamber pre-filled ready-to-use injection device also includes a cap 11, which can be threadedly connected to the liquid outlet pipe. A third rubber plug 12 is fixed inside the cap. The third rubber plug is made of a flexible material. Preferably, the third rubber plug is made of halogenated butyl rubber.

[0048] Embodiment 2:

[0049] This embodiment discloses a working method of the powder and solvent dual-chamber pre-filled ready-to-use injection device described in Embodiment 1, comprising the following steps:

[0050] Powder 13 is pre-loaded into the powder syringe, solvent 14 is pre-loaded into the liquid syringe, and the powder syringe, liquid syringe, first push rod, second push rod and cap are assembled. At this time, the second push rod is inserted into the opening of the first rubber plug to seal the opening of the first rubber plug for use.

[0051] When the drug needs to be injected, the second push rod is pulled out so that the end of the second push rod moves into the opening of the second rubber plug, and the first push rod is pushed so that the first push rod, the second push rod and the second rubber plug move in the liquid syringe, and the solvent in the liquid syringe is pressed into the powder syringe through the opening of the first rubber plug, and the solvent and the powder are mixed to form a mixed drug 15. At this time, the first rubber plug and the second rubber plug are in contact, and the second push rod is pushed, and the second push rod is reinserted into the opening of the first rubber plug, thereby achieving the blocking of the opening of the first rubber plug and completing the preparation work before injection.

[0052] When injection is needed, remove the cap and the needle end leaves the third rubber stopper. At this time, continue to push the third push rod, which drives the first rubber stopper, the second rubber stopper, and the liquid syringe to move synchronously toward the needle, push out the air, and eject the mixed drug through the needle.

[0053] The operation is simple and time-saving, and the solvent and powder are both in a closed space, which will not contaminate the drug. Compared with the traditional method of using a syringe, there is no need to puncture the powder and solution package twice, which avoids the needle from becoming blunt or burred, reduces the pain when the needle pierces the human body, and avoids allergies caused by the rubber component on the needle in sensitive individuals.

[0054] Embodiment 3:

[0055] This embodiment discloses a powder and solvent dual chamber pre-filled ready-to-use injection device, such as Figure 3 As shown, the difference from Example 1 is that the second push rod is not provided, and the second rubber plug is not provided with an opening. A one-way valve is installed at the opening of the first rubber plug. Preferably, the one-way valve adopts a silicone one-way valve 16, so that the solvent can only flow from the aqueous syringe to the powder syringe, and will not flow in the opposite direction, thereby playing a role in blocking the opening of the first rubber plug.

[0056] The other structures are the same as those in Example 1 and will not be described in detail here.

[0057] Embodiment 4:

[0058] This embodiment discloses a working method of the powder and solvent dual-chamber pre-filled ready-to-use injection device described in Example 3, such as Figure 4 As shown, the following steps are included:

[0059] Powder is pre-loaded into the powder syringe, solvent is pre-loaded into the liquid syringe, and the powder syringe, liquid syringe, first push rod and cap are assembled.

[0060] When injection is required, the first push rod is pushed, and the second rubber plug injects the solvent into the powder syringe through the silicone one-way valve, and the solvent and powder are mixed to form a mixed drug 15, and the cap is removed to complete the preparation before injection.

[0061] During injection, the first push rod is continuously pushed, and the first push rod drives the first rubber plug, the second rubber plug and the liquid syringe to move, pushes out the air, and ejects the mixed medicine through the needle.

[0062] In this embodiment, since the one-way silicone valve cannot ensure its sealing after being placed for a long time, its use effect is not as good as that of embodiment 1.

[0063] Although the above describes the specific implementation mode of the present invention in conjunction with the accompanying drawings, it is not intended to limit the scope of protection of the present invention. Those skilled in the art should understand that various modifications or variations that can be made by those skilled in the art on the basis of the technical solution of the present invention without creative work are still within the scope of protection of the present invention.

Claims

1. A powder and solvent dual-chamber pre-filled ready-to-use injection device, characterized in that: It comprises a powder syringe, a needle is provided at the end of the powder syringe, a liquid syringe is inserted into the powder syringe, the liquid syringe can move along the axial direction of the powder syringe, a first rubber plug tightly fitting the inner cylinder surface of the powder syringe is fixed to the end of the liquid syringe inserted into the powder syringe, a first push rod is inserted into the liquid syringe, a second rubber plug tightly fitting the inner cylinder surface of the liquid syringe is fixed to the end of the first push rod, a second push rod passes through the first push rod, both the first rubber plug and the second rubber plug are provided with an opening for the second push rod to pass through, and the hole surface of the opening can be tightly fitted with the second push rod; it also comprises a cap that can be detachably fixedly connected to the end of the powder syringe provided with the needle, a third rubber plug is fixed in the cap, and the needle can be inserted into the third rubber plug; The first rubber plug includes a sealing portion and a connecting portion, wherein the outer peripheral surface of the sealing portion is tightly fitted with the inner cylinder surface of the powder syringe, and the connecting portion is fixedly connected to the end of the liquid syringe; The second rubber plug sleeve is located at the periphery of the end of the first push rod and is fixedly connected to the first push rod.

2. A powder and solvent dual-chamber pre-filled ready-to-use injection device as claimed in claim 1, characterized in that: The connecting part is inserted into the liquid medicine syringe and is fixed with the liquid medicine syringe by pressing or bonding.

3. A powder and solvent dual-chamber pre-filled ready-to-use injection device as claimed in claim 1, characterized in that: The outer peripheral surface of the connecting part is provided with a plurality of clamping grooves, and the inner cylinder surface of the end of the liquid medicine syringe is provided with a plurality of clamping rings, which are clamped into the clamping grooves, and the connecting part is clamped and fixed with the liquid medicine syringe through the clamping grooves and the clamping rings.

4. A method for operating the powder and solvent dual-chamber pre-filled ready-to-use injection device according to claim 1, characterized in that: The following steps are involved: Powder is pre-loaded into the powder syringe, solvent is pre-loaded into the liquid syringe, the powder syringe, the liquid syringe, the first push rod, the second push rod, and the cap are assembled, and the second push rod is inserted into the opening of the first rubber plug to seal the opening of the first rubber plug for use; When the drug needs to be injected, the second push rod is pulled out so that the end of the second push rod moves into the opening of the second rubber plug, and the first push rod is pushed so that the first push rod, the second push rod and the second rubber plug move in the liquid syringe, and the solvent in the liquid syringe is pressed into the powder syringe through the opening of the first rubber plug, and the solvent and the powder are mixed to form a mixed drug. At this time, the first rubber plug is in contact with the second rubber plug, and the second push rod is pushed, and the second push rod is reinserted into the opening of the first rubber plug to seal the opening of the first rubber plug, thereby completing the preparation work before injection.

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