Drug liquid infusion device and manufacturing method therefor

Abstract

Disclosed are a drug liquid infusion device and a manufacturing method therefor. The drug liquid infusion device comprises a first separate unit and a second separate unit. The first separate unit comprises a driving pump, an injector, and a circuit board, the injector comprises a power liquid cavity and a drug liquid cavity separated by a first piston, the power liquid cavity is connected to a liquid outlet of the driving pump by means of a pipe, the circuit board is provided with a control circuit and is electrically connected to the driving pump, and a first quick-connection structure is arranged at a liquid inlet of the driving pump. The second separate unit comprises a volume-variable driving liquid container, and a second quick-connection structure is arranged at a liquid outlet of the driving liquid container. When the first separate unit and the second separate unit are combined to form the drug liquid infusion device in a use state, the first quick-connection structure and the second quick-connection structure form a sealed connection and enable the driving liquid container to be in communication with the driving pump. According to the drug liquid infusion device of the present invention, by means of structural improvement, the manufacturing difficulty is effectively reduced, and therefore the production efficiency can be improved.

Description

A drug infusion device and its manufacturing method

[0001] This application claims priority to Chinese Patent Application No. 202410497945.2, filed on April 24, 2024, entitled "A Drug Infusion Device and a Method for Manufacturing the Same", the entire contents of which are incorporated herein by reference. Technical Field

[0002] This invention relates to the field of medical device technology, and in particular to a drug infusion device and its manufacturing method. Background Technology

[0003] Medical devices must be sterilized before leaving the factory. However, for medical devices that contain both liquids (such as kinetic fluid) and circuit boards, the liquids and circuit boards are not compatible with the same sterilization methods, which poses a great challenge to manufacturing.

[0004] Summary of the Invention

[0005] In view of this, the object of the present invention is to provide a drug infusion device, which, through structural improvements, effectively reduces manufacturing difficulty and thus helps to improve production efficiency. Another object of the present invention is to provide a method for manufacturing the drug infusion device.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] A drug infusion device, comprising:

[0008] The first split unit includes a drive pump, a syringe, and a circuit board. The syringe includes a power fluid chamber and a drug fluid chamber separated by a first piston. The power fluid chamber is connected to the outlet of the drive pump through a pipeline. The circuit board is provided with a control circuit and is electrically connected to the drive pump. The inlet of the drive pump is provided with a first quick-connect structure.

[0009] The second split unit includes a variable-volume driving liquid container, and the outlet of the driving liquid container is provided with a second quick-connect structure.

[0010] When the first split unit and the second split unit are combined to form the drug infusion device in use, the first quick-connect structure and the second quick-connect structure are sealed together and connected to the drive liquid container and the drive pump.

[0011] Optionally, in the above-mentioned drug infusion device, the first quick-connect structure and the second quick-connect structure are connected by plugging and / or screwing.

[0012] Optionally, in the above-mentioned drug infusion device, the first quick-connect structure is configured as a needle and the second quick-connect structure is configured as a rubber stopper; or, the first quick-connect structure is configured as a rubber stopper and the second quick-connect structure is configured as a needle.

[0013] Optionally, in the above-mentioned drug infusion device, the driving liquid container is configured as a soft bag or a rigid cylinder containing a second piston.

[0014] Optionally, in the above-mentioned drug infusion device, the first split unit includes a first rigid shell, the drive pump, the syringe and the circuit board are located inside the first rigid shell, and the surface of the first rigid shell has a first opening for exposing the first quick-connect structure;

[0015] The second split unit includes a second rigid housing, the driving fluid container is located inside the second rigid housing, and the surface of the second rigid housing has a second opening for exposing the second quick-connect structure.

[0016] Optionally, the above-mentioned drug infusion device includes a first vacuum-sealed bag and a second vacuum-sealed bag, wherein the first split unit is located inside the first vacuum-sealed bag and the second split unit is located inside the second vacuum-sealed bag.

[0017] Optionally, in the above-mentioned drug infusion device, the first rigid shell is shaped as an irregular body with a regular groove structure, and the second rigid shell is shaped as a regular body that matches the regular groove structure. When the first split unit and the second split unit are combined to form the drug infusion device in use, the second rigid shell fills the gap of the first rigid shell at the regular groove structure and obtains a combination body with a regular body shape.

[0018] A method for manufacturing a drug infusion device, wherein the drug infusion device is a drug infusion device as disclosed in any of the preceding claims, the method comprising:

[0019] The first and second separate units are sterilized independently. The first separate unit is sterilized by ethylene oxide, and the second separate unit is sterilized by irradiation.

[0020] Optionally, the above manufacturing method further includes:

[0021] After sterilization, the first and second separate units are bagged independently. The first separate unit is placed into a first vacuum-sealed bag, and the second separate unit is placed into a second vacuum-sealed bag.

[0022] Optionally, the above manufacturing method further includes:

[0023] After the first and second separate units are bagged independently, the first vacuum-sealed bag and the second vacuum-sealed bag are packaged into an outer packaging bag with an easy-tear opening.

[0024] The drug infusion device provided by this invention has the following beneficial effects:

[0025] The drug infusion device of the present invention, through structural improvements, achieves the effect that the circuit board and the driving liquid container belong to different separate units, while the driving liquid container and the driving pump can be quickly connected. This avoids the need to find a compatible sterilization method for the circuit board and the driving liquid. Therefore, during the manufacturing process, the first separate unit and the second separate unit can be sterilized independently, which effectively reduces the manufacturing difficulty and helps to improve production efficiency. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0027] Figure 1 is a schematic diagram of the first split unit of the drug infusion device provided in Embodiment 1 of the present invention;

[0028] Figure 2 is a schematic diagram of the second split unit of the drug infusion device provided in Embodiment 1 of the present invention;

[0029] Figure 3 is a schematic diagram of the drug infusion device provided in Embodiment 1 of the present invention in use;

[0030] Figure 4 is a schematic diagram of the commercially available drug infusion device provided in Embodiment 1 of the present invention.

[0031] Figure 5 is a schematic diagram of the second split unit of the drug infusion device provided in Embodiment 2 of the present invention;

[0032] Figure 6 is a schematic diagram of the first split unit of the drug infusion device provided in Embodiment 3 of the present invention;

[0033] Figure 7 is a schematic diagram of the second split unit of the drug infusion device provided in Embodiment 3 of the present invention.

[0034] The following are labeled in the diagram: 1. Circuit board; 2. Cable; 3. Drive pump; 4. Rubber stopper; 5. Pipeline; 6. First piston; 7. First rigid shell; 8. Dosing port; 9. Discharge port; 10. Second rigid shell; 11. Drive fluid container; 12. Drive fluid; 13. Needle; 14. First vacuum sealing bag; 15. Second vacuum sealing bag; 16. Second piston. Detailed Implementation

[0035] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0036] Referring to Figures 1-4, Embodiment 1 of the present invention provides a drug infusion device, comprising a first split unit and a second split unit. The first split unit includes a drive pump 3, a syringe, and a circuit board 1. The syringe includes a power fluid chamber and a drug fluid chamber separated by a first piston 6. The power fluid chamber is connected to the outlet of the drive pump 3 via a pipe 5. The circuit board 1 is equipped with a control circuit and is electrically connected to the drive pump 3. A first quick-connect structure is provided at the inlet of the drive pump 3. The second split unit includes a variable-volume drive fluid container 11, and a second quick-connect structure is provided at the outlet of the drive fluid container 11. When the first and second split units are combined to form the drug infusion device in use, the first and second quick-connect structures are sealed together and conduct electricity between the drive fluid container 11 and the drive pump 3. In the non-use state of the drug infusion device, such as the commercially available state shown in Figure 4, the first and second split units are not combined, i.e., they are in a separate state.

[0037] Referring to Figures 1 and 2, since the first and second separate units can exist relatively independently when the drug infusion device is not in use, they can be sterilized independently during the manufacturing process. For example, the first separate unit can be sterilized with ethylene oxide, completely avoiding the risk of damage to the circuit board 1 from irradiation sterilization, while the second separate unit can be sterilized by irradiation, effectively sterilizing the driving fluid 12 in the driving fluid container 11. Thus, the drug infusion device of the present invention can implement the sterilization process more quickly and efficiently. Compared to the manufacturing difficulties faced by traditional drug infusion devices due to the need to find compatible sterilization methods for the circuit board 1 and the driving fluid 12, the drug infusion device of the present invention, through structural improvements, achieves the effect that while the circuit board 1 and the driving fluid container 11 belong to different separate units, the driving fluid container 11 and the driving pump 3 can be quickly connected. This avoids the necessity of finding compatible sterilization methods for the circuit board 1 and the driving fluid 12, effectively reducing manufacturing difficulty and helping to improve production efficiency.

[0038] It should be noted that the quick-connect structure in this invention refers to a structure that enables rapid connection and assembly. This is easily understood; medical devices should be assembled as quickly as possible during use to save time spent on intermediate steps. There are various forms of quick-connect structures to choose from. In a preferred embodiment, the first and second quick-connect structures are connected by insertion and / or screwing. For example, one of the first and second quick-connect structures can be a needle, and the other a rubber stopper, achieving a quick connection through insertion. Another example is that one of the first and second quick-connect structures can be a connector with external threads, and the other a connector with internal threads, achieving a quick connection through screwing. Yet another example is that one of the first and second quick-connect structures can be a connector with external threads and a rubber stopper, and the other a connector with internal threads and a needle at its center; while the internal and external threads are screwed together, the needle is inserted into the rubber stopper.

[0039] In Embodiment 1 shown in Figures 1 and 2, the first quick-connect structure is configured as a rubber stopper 4, and the second quick-connect structure is configured as a needle 13. In Embodiment 3 shown in Figures 6 and 7, the first quick-connect structure is configured as a needle 13, and the second quick-connect structure is configured as a rubber stopper 4. The working principle of the drug infusion device provided in Embodiments 1 and 3 is the same. For simplicity, the working principle of the drug infusion device will be described below through Embodiment 1. Referring to Figures 1 to 3, when using the drug infusion device to infuse medication into a patient, the first and second split units combine to form the drug infusion device in the usage state shown in Figure 3. The needle 13 passes through the rubber stopper 4 to connect the drive fluid container 11 with the drive pump 3. The control circuit of the circuit board 1 sends control commands to the drive pump 3 through the cable 2 to control the operation of the drive pump 3. Under the action of the drive pump 3, the drive fluid 12 in the drive fluid container 11 first flows into the drive pump 3, and then flows into the power fluid chamber of the syringe through the tube 5, pushing the first piston 6 to move, thereby pushing the medication in the medication chamber out from the medication outlet 9. Finally, the medication enters the patient's body through the infusion tube.

[0040] In practical applications, the type of drive pump 3 can be varied, such as a peristaltic pump or a volumetric pump. It should be noted that the power required by the drive pump 3 can be provided by a power storage module (e.g., a battery) mounted on the circuit board 1; that is, the cable 2 can include wires for transmitting power, or the power storage module can be integrated into the drive pump 3. Before infusing medication to a patient, the medication to be infused should be added to the syringe's medication chamber through the syringe's injection port 8. Before the first and second split units are combined, the first split unit does not contain kinetic fluid; therefore, when the first split unit is stored at low temperatures, liquid expansion due to freezing will not occur, thus preventing damage and leakage to the drive pump 3.

[0041] The variable volume of the driving fluid container 11 means that when the driving pump 3 delivers the driving fluid 12 from the driving fluid container 11 to the syringe, the volume of the driving fluid container 11 gradually decreases under atmospheric pressure as the amount of driving fluid 12 decreases. In practical applications, the structure of the driving fluid container 11 can be varied. For example, in Embodiment 1 shown in Figure 2 and Embodiment 3 shown in Figure 7, the driving fluid container 11 is configured as a soft bag, which gradually deflates as the amount of driving fluid 12 decreases. As another example, in Embodiment 2 shown in Figure 5, the driving fluid container 11 is configured as a rigid cylinder containing a second piston 16, which moves along the rigid cylinder under atmospheric pressure as the amount of driving fluid 12 decreases.

[0042] In a preferred embodiment, the first modular unit includes a first rigid housing 7, within which the drive pump 3, syringe, and circuit board 1 are located. The surface of the first rigid housing 7 has a first opening for exposing the first quick-connect structure. The second modular unit includes a second rigid housing 10, within which the drive fluid container 11 is located. The surface of the second rigid housing 10 has a second opening for exposing the second quick-connect structure. The rigid housing protects the components of the modular unit and facilitates assembly. For example, when the first and second quick-connect structures are connected via a plug-in connection, the operator only needs to hold the first rigid housing 7 and the second rigid housing 10 to assemble them, avoiding the need to handle numerous components.

[0043] More preferably, the first rigid outer shell 7 is shaped like an irregular shape with a regular groove structure, and the second rigid outer shell 10 is shaped like a regular body that matches the regular groove structure. When the first and second separate units are combined to form a drug infusion device in use, the second rigid outer shell 10 fills the gap in the regular groove structure of the first rigid outer shell 7 and obtains a combination body with a regular body shape. It should be understood that a regular body refers to an object with a regular geometric shape, such as a cylinder, cuboid, or cube. Through the above structural design, the structure itself guides the operator to correctly assemble the drug infusion device. For example, in Embodiment 1 shown in Figures 1 and 2, the operator sees that the second rigid outer shell 10 can fit precisely into the gap in the first rigid outer shell 7, and can quickly think of placing the second separate unit into the gap in the first rigid outer shell 7 to achieve combination with the first separate unit. In addition, since the combination body obtained after the first and second separate units are combined is a regular body shape, the drug infusion device has strong overall stability in use, that is, the first and second separate units are not easily misaligned or separated.

[0044] As shown in Figure 4, in a preferred embodiment, the drug infusion device includes a first vacuum-sealed bag 14 and a second vacuum-sealed bag 15. The first separate unit is located inside the first vacuum-sealed bag 14, and the second separate unit is located inside the second vacuum-sealed bag 15. The drug infusion device can be sold in the state shown in Figure 4. Alternatively, the complete set of the first and second separate units can be packaged together in the same outer packaging (e.g., a box or bag) for sale.

[0045] This invention also provides a method for manufacturing a drug infusion device, used to manufacture the drug infusion device provided by this invention. The manufacturing method includes: independently sterilizing a first separate unit and a second separate unit, wherein the first separate unit is sterilized by ethylene oxide, and the second separate unit is sterilized by irradiation. It should be noted that the process parameters during sterilization can use conventional parameters, which will not be described in detail here.

[0046] More preferably, the manufacturing method of the drug infusion device further includes: after sterilization, independently bagging the first split unit and the second split unit, wherein the first split unit is placed into a first vacuum-sealed bag 14, and the second split unit is placed into a second vacuum-sealed bag 15. It should be understood that the above bagging process includes vacuuming and sealing operations, and conventional process parameters can be used, which will not be described in detail here.

[0047] More preferably, the manufacturing method of the drug infusion device further includes: after independently bagging the first split unit and the second split unit, packaging the first vacuum-sealed bag 14 and the second vacuum-sealed bag 15 into an outer packaging bag with an easy-tear opening. In this way, the complete set of the first split unit and the second split unit are packaged in the same outer packaging bag for easy access. Product information of the drug infusion device can be printed on the outer packaging bag; for example, if the drug infusion device is a micro-infusion device, the outer packaging bag can be printed with the words "medical micro-infusion device." In addition, illustrations showing the combined operation process of the first split unit and the second split unit can also be printed on the outer packaging bag.

[0048] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0049] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A drug infusion device, characterized in that, include: The first split unit includes a drive pump, a syringe, and a circuit board. The syringe includes a power fluid chamber and a drug fluid chamber separated by a first piston. The power fluid chamber is connected to the outlet of the drive pump through a pipeline. The circuit board is provided with a control circuit and is electrically connected to the drive pump. The inlet of the drive pump is provided with a first quick-connect structure. The second split unit includes a variable-volume driving liquid container, and the outlet of the driving liquid container is provided with a second quick-connect structure. When the first split unit and the second split unit are combined to form the drug infusion device in use, the first quick-connect structure and the second quick-connect structure are sealed together and connected to the drive liquid container and the drive pump.

2. The drug infusion device according to claim 1, characterized in that, The first quick-connect structure and the second quick-connect structure are connected by plugging and / or screwing.

3. The drug infusion device according to claim 1, characterized in that, The first quick-connect structure is configured as a needle, and the second quick-connect structure is configured as a rubber stopper; or, the first quick-connect structure is configured as a rubber stopper, and the second quick-connect structure is configured as a needle.

4. The drug infusion device according to claim 1, characterized in that, The driving fluid container is configured as a soft bag or a rigid cylinder containing a second piston.

5. The drug infusion device according to any one of claims 1 to 4, characterized in that, The first split unit includes a first rigid housing, the drive pump, the syringe and the circuit board are located inside the first rigid housing, and the surface of the first rigid housing has a first opening for exposing the first quick-connect structure; The second split unit includes a second rigid housing, the driving fluid container is located inside the second rigid housing, and the surface of the second rigid housing has a second opening for exposing the second quick-connect structure.

6. The drug infusion device according to claim 5, characterized in that, It includes a first vacuum-sealed bag and a second vacuum-sealed bag, with the first split unit located inside the first vacuum-sealed bag and the second split unit located inside the second vacuum-sealed bag.

7. The drug infusion device according to claim 5, characterized in that, The first rigid shell is shaped as an irregular shape with a regular groove structure, and the second rigid shell is shaped as a regular shape that matches the regular groove structure. When the first split unit and the second split unit are combined to form the drug infusion device in use, the second rigid shell fills the gap of the first rigid shell at the regular groove structure and obtains a combination body with a regular shape.

8. A method for manufacturing a drug infusion device, characterized in that, The drug infusion device is the drug infusion device as described in any one of claims 1 to 7, and the manufacturing method includes: The first and second separate units are sterilized independently. The first separate unit is sterilized by ethylene oxide, and the second separate unit is sterilized by irradiation.

9. The manufacturing method according to claim 8, characterized in that, Also includes: After sterilization, the first and second separate units are bagged independently. The first separate unit is placed into a first vacuum-sealed bag, and the second separate unit is placed into a second vacuum-sealed bag.

10. The manufacturing method according to claim 9, characterized in that, Also includes: After the first and second separate units are bagged independently, the contents are then... The first vacuum-sealed bag and the second vacuum-sealed bag are packaged into an outer packaging bag with an easy-tear opening.

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