Syringe system and method for manufacturing prefilled syringe

Abstract

To provide a syringe system having a function capable of filling a lumen of a tubular member with liquid without removing the tumular member from an injection needle or a catheter in a state where the injection needle is punctured into a treatment object part or a catheter is inserted therein, and manufacturing method of a prefilled syringe using the syringe system.SOLUTION: A syringe system 1 includes a tubular member 10 having a distal end and a proximal end and an inlet 20 formed proximal to the distal end and distal to the proximal end, a gasket 30 disposed in a lumen of the tubular member 10, a plunger 40 connected to the gasket 30, and a container 50 communicably connected to the lumen of the tubular member 10 via the inlet 20, and is configured to fill the lumen of the tubular member 10 with liquid 2 contained in the container 50 via the inlet 20. The manufacturing method of the prefilled syringe using the syringe system is also provided.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] The present invention relates to a syringe system and a method for manufacturing a pre-filled syringe. [Background technology]

[0002] 2. Description of the Related Art When administering a liquid such as a drug solution to a patient, the liquid may be directly injected into the body using a syringe and injection needle or a catheter.

[0003] In recent years, there has been active research into a treatment known as regenerative medicine, which uses cells and tissues cultured outside the body. In the field of regenerative medicine, a cell suspension containing cells to be transplanted is filled into a syringe connected to an injection needle and then directly injected into the organ to be treated, or a cell suspension containing cells to be transplanted is filled into a syringe connected to a catheter and then injected after the distal end of the catheter has been transported to the site to be treated.

[0004] When performing treatment by directly administering liquids such as drug solutions or cell suspensions into the body, the operation of filling a syringe with the liquid on-site is cumbersome and time-consuming. In order to reduce the workload on-site, a prefilled syringe and a storage container for a prefilled syringe, as described in Patent Document 1, have been developed that can be transported in a state where the syringe is prefilled with the liquid. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2001-104475 Summary of the Invention [Problem to be solved by the invention]

[0006] However, the prefilled syringe described in Patent Document 1 has a limited liquid capacity. If the amount of liquid prefilled in the syringe is insufficient, the empty syringe must be removed from the injection needle or catheter and a new prefilled syringe must be connected after the injection needle or catheter has been inserted into the treatment target area, or the empty syringe must be removed from the injection needle or catheter and a new prefilled syringe must be connected. Alternatively, the empty syringe must be removed from the injection needle or catheter and the plunger must be pulled to aspirate additional liquid into the syringe, which must then be refilled and reconnected to the injection needle or catheter. Such procedures are prone to contamination and air contamination, which increase the risk of cell death and damage to the target organ. In particular, transplanting a cell suspension into the brain increases the risk of affecting the nervous system. Furthermore, such procedures require the syringe to be removed from and connected to the injection needle while the injection needle is still inserted into the treatment target area. Similarly, in the case of catheterization, the syringe must be removed from and connected to the catheter while the catheter is still inserted into the treatment target area. This also poses the problem of changing the puncture position of the injection needle or the insertion position of the catheter before and after the syringe is connected. This not only makes it difficult to inject liquid into a specific location in a specific organ, but also increases the risk of damaging the surrounding tissue by requiring the needle or catheter to be readjusted, and increases the burden on the patient or user by lengthening the procedure time.

[0007] The present invention has been made in consideration of the above circumstances, and its purpose is to provide a syringe system and a method for manufacturing a prefilled syringe that have the function of filling a syringe with a liquid without removing the syringe from the injection needle or catheter when the injection needle is inserted into the treatment area or when a catheter is inserted into the treatment area. [Means for solving the problem]

[0008] One embodiment of the syringe system of the present invention that solves the above-mentioned problems comprises a tubular member having a distal end and a proximal end, and an injection port formed proximal to the distal end and distal to the proximal end, a gasket disposed in the lumen of the tubular member, a plunger disposed in the lumen of the tubular member and connected to the gasket, and a container connected to the lumen of the tubular member so as to be communicatively connected to the lumen of the tubular member via the injection port, and is configured so that a liquid contained in the container can be filled into the lumen of the tubular member via the injection port. With this configuration, the liquid contained in the container can be filled into the lumen of the tubular member via the injection port of the tubular member. Therefore, when a treatment target area is punctured with an injection needle or a catheter is inserted into the treatment target area, the liquid can be filled into the lumen of the tubular member without removing the tubular member from the injection needle or catheter.

[0009] The container is preferably equipped with a pressurizing device.

[0010] The tubular member preferably has a first region and a second region located proximal to the first region and having an outer diameter larger than that of the first region.

[0011] The inlet may be formed in the second region.

[0012] The second region may extend from the proximal end of the first region and have a tapered portion where the lumen becomes smaller toward the distal side, and the injection port may be formed in the tapered portion.

[0013] The inlet may be formed in the first region.

[0014] The configuration may include a tube connecting the inlet and the container.

[0015] At least one of the inlet and the tube preferably has a first control section that can block communication between the lumen of the tubular member and the container.

[0016] The first control unit preferably has a lid portion capable of blocking communication between the inner cavity of the cylindrical member and the container, and an operating portion for operating the opening and closing of the lid portion.

[0017] In a syringe system in which the tube is provided with a stopcock and two or more containers are provided, it is preferable that the lumen of the tubular member and the two or more containers are communicatively connected via the tube and the stopcock.

[0018] It is preferable that the device is equipped with a calculation processing unit that measures the amount of liquid filled in the inner cavity of the tubular member and the amount of liquid placed in the container, and calculates the amount of liquid to be filled from the container into the inner cavity of the tubular member based on the measured values.

[0019] It is preferable that at least one of the cylindrical member and the container has a marking formed thereon by laser printing.

[0020] The liquid may be a cell suspension.

[0021] One embodiment of the method for manufacturing a prefilled syringe of the present invention that solves the above-mentioned problems is characterized by the steps of preparing the syringe system and a liquid, pouring the liquid into a container, decompressing the lumen of the tubular member by moving the gasket from the distal side to the proximal side of the tubular member, and filling the lumen of the tubular member with the liquid from the container by decompression. This configuration makes it possible to manufacture a prefilled syringe that can fill the lumen of the tubular member with the liquid contained in the container through the inlet of the tubular member. With a prefilled syringe manufactured in this way, even if the amount of liquid previously filled is small, the lumen of the tubular member can be refilled with liquid when the injection needle is inserted into the treatment area or the catheter is inserted, without removing the tubular member from the injection needle or catheter.

[0022] Another embodiment of the method for manufacturing a prefilled syringe of the present invention that solves the above-mentioned problems is characterized by comprising the steps of preparing the syringe system, filling a container with the liquid, applying pressure to the liquid, and filling the lumen of a tubular member with the liquid from the container by the applied pressure. This configuration makes it possible to manufacture a prefilled syringe that can fill the lumen of the tubular member with the liquid contained in the container through the inlet of the tubular member. With a prefilled syringe manufactured in this way, even if the amount of liquid previously filled is small, the lumen of the tubular member can be refilled with liquid when the injection needle is inserted into the treatment area or the catheter is inserted, without removing the tubular member from the injection needle or catheter.

[0023] The method for manufacturing a pre-filled syringe may further include a step of packaging the syringe system after the step of filling the lumen of the tubular member with liquid from a container. [Effects of the Invention]

[0024] The syringe system of the present invention has the function of being able to fill the lumen of the tubular member with a liquid when the injection needle is inserted into the treatment area or when a catheter is inserted, without removing the tubular member from the injection needle or catheter. Furthermore, the method for manufacturing a prefilled syringe of the present invention can be used to manufacture a prefilled syringe that has the function of being able to fill the lumen of the tubular member with a liquid when the injection needle is inserted into the treatment area or when a catheter is inserted, without removing the tubular member from the injection needle or catheter. [Brief explanation of the drawings]

[0025] [Figure 1] 1 is a cross-sectional view of a syringe system according to an embodiment of the present invention. [Figure 2] 10 is a cross-sectional view showing a modified example of a cylindrical member provided in the syringe system according to the embodiment of the present invention. FIG. [Figure 3] 10 is a cross-sectional view showing a modified example of a cylindrical member provided in the syringe system according to the embodiment of the present invention. FIG. [Figure 4] 10 is a cross-sectional view showing a modified example of a cylindrical member provided in the syringe system according to the embodiment of the present invention. FIG. [Figure 5] 10 is a cross-sectional view showing a modified example of a cylindrical member provided in the syringe system according to the embodiment of the present invention. FIG. [Figure 6] FIG. 10 is a cross-sectional view showing a modified example of the syringe system according to the embodiment of the present invention. [Figure 7] 10 is a cross-sectional view showing a modified example of a tube provided in a syringe system according to an embodiment of the present invention. [Figure 8] 10 is a cross-sectional view showing a modified example of a tube provided in a syringe system according to an embodiment of the present invention. [Figure 9] FIG. 10 is a cross-sectional view (partial side view) showing a modified example of the syringe system according to the embodiment of the present invention. [Figure 10] FIG. 10 is a cross-sectional view (partial side view) showing a modified example of the syringe system according to the embodiment of the present invention. [Figure 11] FIG. 10 is a side view showing a modified example of the syringe system according to the embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0026] The present invention will be described in detail below with reference to the drawings. However, the present invention is not limited to the illustrated examples, and appropriate modifications may be made within the scope of the spirit described above and below, and all such modifications are within the technical scope of the present invention. In the drawings, hatching and symbols may be omitted for convenience. In such cases, reference should be made to the specification and other drawings. Furthermore, the dimensions of various parts in the drawings may differ from the actual dimensions, as priority is given to helping understand the features of the present invention.

[0027] A syringe system according to one embodiment of the present invention includes a tubular member having a distal end and a proximal end, and an injection port formed proximal to the distal end and distal to the proximal end, a gasket disposed in the lumen of the tubular member, a plunger disposed in the lumen of the tubular member and connected to the gasket, and a container connected to the lumen of the tubular member so as to be able to communicate with the lumen of the tubular member via the injection port, and is configured so that a liquid contained in the container can be filled into the lumen of the tubular member via the injection port. With this configuration, the liquid contained in the container can be filled into the lumen of the tubular member via the injection port of the tubular member. Therefore, when a treatment target area is punctured with an injection needle or a catheter is inserted into the treatment target area, the liquid can be filled into the lumen of the tubular member without removing the tubular member from the injection needle or the catheter.

[0028] Syringe systems are used to administer liquids such as medicinal solutions to patients undergoing treatment.

[0029] The liquid may be, for example, a drug solution, blood, a cell suspension, etc. Among these, the liquid may be suitably used when injecting a cell suspension into a treatment target area.

[0030] The overall configuration of a syringe system will be described with reference to FIGS. 1 to 11. FIG. 1 is a cross-sectional view of a syringe system according to an embodiment of the present invention. FIG. 2 is a cross-sectional view showing a modified example of a cylindrical member included in a syringe system according to an embodiment of the present invention. FIG. 3 is a cross-sectional view showing a modified example of a cylindrical member included in a syringe system according to an embodiment of the present invention. FIG. 4 is a cross-sectional view showing a modified example of a cylindrical member included in a syringe system according to an embodiment of the present invention. FIG. 5 is a cross-sectional view showing a modified example of a cylindrical member included in a syringe system according to an embodiment of the present invention. FIG. 6 is a cross-sectional view showing a modified example of a syringe system according to an embodiment of the present invention. FIG. 7 is a cross-sectional view showing a modified example of a tube included in a syringe system according to an embodiment of the present invention. FIG. 8 is a cross-sectional view showing a modified example of a tube included in a syringe system according to an embodiment of the present invention. FIG. 9 is a cross-sectional view (partially a side view) showing a modified example of a syringe system according to an embodiment of the present invention. FIG. 10 is a cross-sectional view (partially a side view) showing a modified example of a syringe system according to an embodiment of the present invention. FIG. 11 is a side view showing a modified example of a syringe system according to an embodiment of the present invention. 1, 6, 9, and 10 show examples of the configuration of a syringe system 1 including a tubular member 10 having an injection port 20 formed therein, a gasket 30 disposed in the lumen of the tubular member 10, a plunger 40 disposed in the lumen of the tubular member 10 and connected to the gasket 30, and a container 50 connected so as to be communicable with the lumen of the tubular member 10 via the injection port 20. In each drawing, the upper side of the paper corresponds to the proximal side of the tubular member 10, and the lower side of the paper corresponds to the distal side of the tubular member 10.

[0031] In this specification, the proximal side refers to the side closer to the user in the extension direction of the tubular member 10, and the distal side refers to the side opposite the proximal side, i.e., the side to be treated. The distal portion of the tubular member 10 refers to the distal half of the tubular member 10, and the proximal portion of the tubular member 10 refers to the proximal half of the tubular member 10. The extension direction of the tubular member 10 is referred to as the longitudinal axis direction. The radial direction refers to the radial direction of the tubular member 10, and in this specification, the inward direction refers to the radial direction toward the axial center of the tubular member 10, and the outward direction refers to the direction opposite the inward direction.

[0032] It is preferable that the materials of the components constituting the syringe system 1 are biocompatible.

[0033] As shown in Figure 1, the syringe system 1 includes a tubular member 10 having a distal end and a proximal end. The tubular member 10 may have multiple lumens, but preferably has only one lumen. The shape of the tubular member 10 is not particularly limited as long as it has a lumen, and it can be, for example, a hollow cylinder or a hollow polygonal prism. Hereinafter, a cross section perpendicular to the longitudinal axis of the lumen of the tubular member 10 will be referred to as a lumen cross section.

[0034] The shape of the cross section of the lumen of the tubular member 10 is not particularly limited, but may be, for example, a circle, an oval, a polygon, a star, or a combination of these. Note that the oval shape includes an ellipse, an egg, and a rounded rectangle. The same applies to the following description.

[0035] The cylindrical member 10 can be made of materials including, for example, hard borosilicate glass, cyclic olefin polymer, polypropylene, etc. These may be used alone or in combination of two or more.

[0036] The distal end of the tubular member 10 can be connected to an injection needle to inject a liquid directly into the body from the distal end of the needle. The distal end of the tubular member 10 can be connected to a catheter to inject a liquid directly into the body from the distal end of the catheter. The distal end of the tubular member 10 and the injection needle may be connected via a catheter.

[0037] As shown in FIG. 1, an injection port 20 through which a liquid can be injected into the lumen of the tubular member 10 is formed proximal to the distal end of the tubular member 10 but distal to the proximal end. The injection port 20 is preferably formed on the side surface of the tubular member 10. The injection port 20 allows a liquid to pass through. As shown in FIGS. 2 to 5, the injection port 20 is preferably a hole or opening that connects the lumen of the tubular member 10 to the outside of the tubular member 10. Note that the injection port 20 may be a hole or opening that connects the lumen of the tubular member 10 to the outside of the tubular member 10 as shown in FIGS. 2 to 5, and the interior of the injection port 20 may be hollow, or a filter or the like may be attached to sterilize the liquid passing through.

[0038] The shape of the injection port 20 is not particularly limited as long as it allows liquid to be injected into the inner cavity of the tubular member 10. For example, the shape of the injection port 20 when viewed from the radially outside of the tubular member 10 can be circular, oval, polygonal, star-shaped, or a combination of these.

[0039] As shown in FIGS. 2 to 5, the tubular member 10 preferably has a first region 11 and a second region 12 located proximal to the first region 11 and having a larger outer diameter than the first region 11. This makes it easier to adjust the amount of liquid that can be filled into the lumen of the tubular member 10 by adjusting the outer diameter of the second region 12 of the tubular member 10. Although not shown, the tubular member 10 may be formed into a cylindrical shape having a constant outer diameter from its distal end to its proximal end. The outer diameter of the tubular member 10 is measured in a cross section perpendicular to the longitudinal axis of the tubular member 10. If the outer shape of the tubular member 10 in the cross section perpendicular to the longitudinal axis is not a perfect circle, the outer diameter is defined as the diameter of the circumscribing circle of the outer shape. This also applies to the following description.

[0040] The first region 11 can be shaped to have any desired outer diameter. The outer diameter of the first region 11 may be constant or may vary.

[0041] The second region 12 refers to a region of the tubular member 10 having a larger outer diameter than the first region 11, and is preferably located closer to the proximal side than the first region 11. The second region 12 can be shaped to have any outer diameter. The outer diameter of the second region 12 may be constant or may vary. As shown in FIGS. 2 to 4, the entire second region 12 may be located closer to the proximal side than the first region 11. As shown in FIG. 5, only a portion of the second region 12 may be located closer to the proximal side than the first region 11.

[0042] 4, the injection port 20 may be formed in the first region 11. This configuration makes it easier to fill the lumen of the tubular member 10 with liquid even after the gasket 30 has been moved to the distal end of the second region 12.

[0043] 2, 3, and 5, the injection port 20 may be formed in the second region 12. Since the second region 12 has a larger outer diameter than the first region 11, it is easier to form the injection port 20 during manufacturing.

[0044] As shown in FIGS. 3 to 5 , the second region 12 may have a tapered diameter section 13 extending from the proximal end of the first region 11, the inner diameter of which decreases distally. The tapered diameter section 13 is a section in which the inner diameter decreases distally. The first region 11 may extend from the distal end of the tapered diameter section 13 as shown in FIGS. 3 and 4 , or the first region 11 may extend from any position proximal to the distal end of the tapered diameter section 13 as shown in FIG. 5 . As shown in FIGS. 3 and 5 , the injection port 20 may be formed in the tapered diameter section 13. Forming the injection port 20 in the tapered diameter section 13 makes it easier to fill the inner lumen of the tubular member 10 with liquid even after the gasket 30 has been moved to the distal end of the second region 12. Furthermore, since the outer diameter of the second region 12 is larger than that of the first region 11, the injection port 20 can be easily formed during manufacturing.

[0045] The syringe system 1 includes a gasket 30 disposed in the inner cavity of the tubular member 10. The gasket 30 is a member that can move in the longitudinal direction of the inner cavity of the tubular member 10 while maintaining a liquid-tight seal. By moving the gasket 30, the liquid filled in the inner cavity of the tubular member 10 can be expelled from the distal end of the tubular member 10.

[0046] The shape of the gasket 30 may be designed appropriately to match the shape of the lumen of the tubular member 10, and may be, for example, a cylindrical shape as shown in Fig. 2 or a shape in which a truncated cone is combined with the distal end of a cylinder as shown in Fig. 3. Although not shown, the shape of the gasket 30 may be a polygonal pillar, or a shape in which a cone is combined with the distal end of a cylinder.

[0047] The gasket 30 can be made of materials including, for example, butyl rubber, isoprene rubber, butadiene rubber, ethylene propylene rubber, silicone rubber, epichlorohydrin rubber, neoprene rubber, etc. These materials may be used alone or in combination of two or more.

[0048] The syringe system 1 is provided with a plunger 40 disposed in the lumen of the tubular member 10 and connected to the gasket 30. By pressing the plunger 40 toward the distal side of the tubular member 10, the gasket 30 moves toward the distal side of the tubular member 10. This causes the liquid to be dispensed from the distal end of the tubular member 10. From the viewpoint of operability, it is preferable that the proximal end of the plunger 40 protrudes from the proximal end of the tubular member 10.

[0049] The plunger 40 can be made of materials including, for example, polypropylene, polystyrene, polyethylene, etc. These may be used alone or in combination of two or more.

[0050] The syringe system 1 includes a container 50. The container 50 is for holding a liquid.

[0051] The container 50 can be made of materials including, for example, polystyrene, polypropylene, polyethylene, fluororesin, borosilicate glass, etc. These may be used alone or in combination of two or more.

[0052] The shape of the container 50 is not particularly limited as long as it can hold a liquid. For example, it may be cylindrical, polygonal, bag-like, etc. As shown in Figures 1 and 6, the container 50 may have a spout 51 for extracting the liquid contained in the container 50.

[0053] The container 50 is connected to the inner cavity of the tubular member 10 via the injection port 20 so as to be able to communicate with it. For example, as shown in FIG. 6 , by providing a tube 60 connecting the injection port 20 and the container 50, the container 50 and the inner cavity of the tubular member 10 can be connected to be able to communicate with it via the injection port 20. In this case, it is preferable to connect the injection port 20 of the tubular member 10 to the pouring outlet 51 of the container 50 so as to be able to communicate with it via the injection port 20. Although not shown, the pouring outlet 51 of the container 50 may be directly connected to the injection port 20 of the tubular member 10 without using a tube. As described above, by connecting the container 50 to the inner cavity of the tubular member 10 via the injection port 20, the liquid 2 contained in the container 50 can be filled into the inner cavity of the tubular member 10 via the injection port 20 of the tubular member 10. Therefore, when the injection needle is inserted into the treatment area or the catheter is inserted, the liquid 2 can be filled into the inner cavity of the tubular member 10 without removing the tubular member 10 from the injection needle or catheter.

[0054] At least one of the injection port 20 and the tube 60 of the syringe system 1 preferably has a first control unit 70 capable of blocking communication between the lumen of the tubular member and the container. Figures 7 and 8 are cross-sectional views showing modified examples of the tube 60 provided in the syringe system according to the embodiment of the present invention. Here, the tube 60 is shown to have a first control unit 70 capable of blocking communication between the lumen of the tubular member and the container. The first control unit may be provided only in the tube, only in the injection port, or both in the tube and the injection port.

[0055] As the first control unit 70, for example, a stopcock, which is known as a device that is attached midway in a pipeline to stop the flow of a fluid or to adjust the flow rate, pressure, etc., may be used.

[0056] 7 shows an embodiment in which the first control unit 70 includes a lid unit 71 that can block communication between the inner cavity of the cylindrical member and the container, and an operating unit 72 that operates to open and close the lid unit 71. The lid unit 71 is preferably capable of blocking the injection port 20 or the tube 60 in a liquid-tight manner. The shape of the lid unit 71 is not particularly limited as long as it can block communication between the inner cavity of the cylindrical member and the container, but it can be, for example, plate-shaped. The operating unit 72 can be, for example, a lever or button that operates to open and close the lid unit 71.

[0057] FIG. 8 shows an embodiment having a first control section 70 that can pinch the tube 60 and crush the inner cavity to block communication between the inner cavity of the tubular member and the container.

[0058] By providing the first control unit 70 as described above, it is possible to connect the container and the lumen of the tubular member via the injection port only when it is necessary to fill the lumen of the tubular member with liquid from the container. Furthermore, when injecting the liquid filled in the lumen of the tubular member into the treatment target area, the first control unit 70 can block the communication, thereby preventing the liquid from flowing out toward the container. This makes it easier to control the movement of liquid between the tubular member and the container.

[0059] Next, we will explain a more specific embodiment for filling the liquid 2 contained in the container 50 into the inner cavity of the tubular member 10 through the injection port 20 of the tubular member 10 in the syringe system 1, in which the container 50 and the inner cavity of the tubular member 10 are connected so as to be able to communicate with each other through the injection port 20 of the tubular member 10.

[0060] In the syringe system 1 in which the container 50 and the inner cavity of the tubular member 10 are communicatively connected via the injection port 20, the inner cavity of the tubular member 10 can be depressurized by moving the plunger 40 proximally through the inner cavity of the tubular member 10 and moving the gasket 30 connected to the plunger 40 proximally through the inner cavity of the tubular member 10. This allows the liquid 2 contained in the container 50 to be filled into the inner cavity of the tubular member 10 via the injection port 20 of the tubular member 10. Therefore, when a treatment target part is punctured with an injection needle or a catheter is inserted, the liquid 2 can be filled into the inner cavity of the tubular member 10 without removing the injection needle or catheter. In this case, there is a possibility that the liquid 2 injected into the treatment target part from the distal end of the tubular member 10 will re-flow into the inner cavity of the tubular member 10 due to the depressurization of the inner cavity of the tubular member 10. To prevent this re-flow, it is preferable that the tubular member 10 has a second control unit 80 at its distal portion that can block communication with the lumen of the tubular member 10, as shown in Figure 9. The specific configuration of the second control unit 80 can be the same as that of the first control unit 70. This makes it possible to prevent the liquid 2 injected from the distal end of the tubular member 10 into the treatment target area from re-flowing into the lumen of the tubular member 10. It is preferable that the second control unit 80 is provided distal to the injection port 20. When the tubular member 10 has a first region and a second region, it is preferable that the second control unit 80 is provided in the first region.

[0061] The syringe system 1 according to an embodiment of the present invention may be configured so that the liquid 2 contained in the container 50 can be filled into the inner cavity of the tubular member 10 through the injection port 20 of the tubular member 10 only by reducing the pressure in the inner cavity of the tubular member 10 as described above.

[0062] Another embodiment for filling the lumen of the tubular member 10 with the liquid 2 contained in the container 50 through the injection port 20 of the tubular member 10 involves applying pressure to the liquid 2 in the container 50. For example, the user can apply pressure by gripping the container 50 with their hand, thereby filling the lumen of the tubular member 10 with the liquid 2 contained in the container 50 through the injection port 20 of the tubular member 10. Therefore, with the injection needle punctured into the treatment area or with the catheter inserted, the lumen of the tubular member 10 can be filled with the liquid 2 without removing the tubular member 10 from the injection needle or catheter.

[0063] As another embodiment for applying pressure to the liquid 2 in the container 50, as shown in FIG. 6 , the container 50 may be provided with a pressurizing device 52. The pressurizing device 52 provided in the container 50 may be, for example, a device that applies pressure directly to the liquid 2 by moving the liquid 2 inside the container 50 in a liquid-tight state. The pressurizing device 52 may also be a device that applies pressure to the liquid 2 by injecting air into the container 50. The pressurizing device 52 may also be a device that applies pressure to the liquid 2 by gradually crushing the container 50 itself. The above configuration makes it easier to stably apply pressure to the liquid 2 contained in the container 50. This makes it easier to move the liquid 2 inside the container 50 into the lumen of the tubular member 10 through the inlet 20 of the tubular member 10. Note that it is preferable that the liquid 2 be exposed to air for a short period of time. Therefore, a device that applies pressure directly to the liquid 2 by moving the liquid 2 inside the container 50 or a device that applies pressure to the liquid 2 by crushing the container 50 itself is preferable.

[0064] When applying pressure to the liquid 2 in the container 50 as described above, there is a possibility that the liquid 2 may flow into the treatment target area from the distal end of the tubular member 10 at an unintended timing. To prevent this, the second control unit 80 described above may be provided at the distal portion of the tubular member 10.

[0065] As described above, the syringe system 1 according to the embodiment of the present invention may be configured so that the liquid 2 in the container 50 can be filled into the lumen of the tubular member 10 through the injection port 20 of the tubular member 10 only by applying pressure to the liquid 2 in the container 50. Furthermore, the syringe system 1 according to the embodiment of the present invention may be configured so that the liquid 2 in the container 50 can be filled into the lumen of the tubular member 10 through the injection port 20 of the tubular member 10 by either reducing the pressure in the lumen of the tubular member 10 or applying pressure to the liquid 2 in the container 50.

[0066] As shown in FIG. 10 , the syringe system 1 preferably includes a processor 90 that measures the amount of liquid filled in the lumen of the tubular member 10 and the amount of liquid placed in the container, and calculates the amount of liquid to be filled from the container 50 into the lumen of the tubular member based on the measured values. For example, sensors 91 and 92 connected to the processor 90 can be disposed on the inner walls of the tubular member 10 and the container 50 to sense the position of the liquid surface and measure the amount of liquid present in the tubular member 10 and the container 50. The processor 90 can then compare the amount of liquid lost from the tubular member 10 with the amount of liquid remaining in the container 50 and calculate the amount of liquid to be refilled into the lumen of the tubular member 10 within a range equal to or less than the amount of liquid remaining in the container 50. The sensors 91 and 92 and the processor 90 can be connected by wires or the like.

[0067] As shown in FIG. 11 , it is preferable that at least one of the tubular member 10 and the container 50 has a marking formed thereon by a laser. The marking may be formed only on the tubular member 10, only on the container 50, or on both the tubular member 10 and the container 50. The marking may be printed on the inner surface or the outer surface of the tubular member. The marking may be printed on the inner surface or the outer surface of the container. By forming a marking on the tubular member by a laser, it becomes easier to check the amount of liquid in the tubular member. By forming a marking on the container by a laser, it becomes easier to check the amount of liquid in the container.

[0068] As shown in FIG. 9 , the syringe system 1 includes a tube 60 equipped with a stopcock 73 and two or more containers 50. Preferably, the lumen of the tubular member 10 is communicatively connected to the two or more containers 50 via the tube 60 and the stopcock 73. The stopcock 73 is a known device that is installed midway through a conduit to stop the flow of a fluid or adjust the flow rate, pressure, etc. As shown in FIG. 9 , the stopcock 73 is preferably a three-way stopcock that can adjust the flow path. While FIG. 9 shows an embodiment in which three containers 50 are provided, the number of containers 50 may be two or four or more. With this configuration, the liquid 2 contained in the container 50 can be filled into the lumen of the tubular member 10 through the inlet 20 of the tubular member 10. Therefore, when a syringe needle is inserted into a treatment area or a catheter is inserted, the liquid 2 can be filled into the lumen of the tubular member 10 without removing the tubular member 10 from the syringe needle or catheter. Furthermore, with the above-described configuration, it becomes possible to store different types of liquids 2 in multiple containers 50. This makes it easier to inject multiple types of liquids 2 into the treatment target area in a predetermined order.

[0069] Next, a method for manufacturing a pre-filled syringe according to an embodiment of the present invention will be described. In the description of the syringe system 1, the same reference numerals will be used to designate the same components as those already described, and the description thereof will be omitted.

[0070] A method for manufacturing a prefilled syringe according to one embodiment of the present invention is characterized in that it includes the steps of preparing the syringe system 1 and the liquid 2, pouring the liquid 2 into a container 50, reducing the pressure in the cavity of the tubular member 10 by moving the gasket 30 from the distal side toward the proximal side of the tubular member 10, and filling the liquid 2 from the container 50 into the cavity of the tubular member 10 by reducing the pressure.

[0071] First, the syringe system 1 and the liquid 2 are prepared, and the liquid 2 is placed in the container 50. Before placing the liquid 2 in the container 50, it is preferable to move the gasket 30 to the distal side of the tubular member 10. Thereafter, the gasket 30 is moved from the distal side toward the proximal side of the tubular member 10 to reduce the pressure in the lumen of the tubular member 10. For example, this is done by moving the plunger 40 toward the distal side of the tubular member 10 by pulling it in the proximal direction of the tubular member 10. By reducing the pressure in the lumen of the tubular member 10, the liquid 2 can be filled from the container 50 into the lumen of the tubular member 10.

[0072] This configuration makes it possible to manufacture a prefilled syringe that can fill the inner cavity of the tubular member 10 with the liquid 2 contained in the container 50 through the inlet 20 of the tubular member 10. With the prefilled syringe manufactured in this way, even if the amount of liquid 2 that was previously filled is small, the inner cavity of the tubular member 10 can be refilled with the liquid 2 when the injection needle is inserted into the treatment area or when the catheter is inserted, without removing the tubular member 10 from the injection needle or catheter.

[0073] A method for manufacturing a prefilled syringe according to another embodiment of the present invention is characterized in that it includes the steps of preparing the syringe system 1 and the liquid 2, placing the liquid 2 in a container 50, applying pressure to the liquid 2, and filling the inner cavity of the tubular member 10 with the liquid 2 from the container 50 by the applied pressure.

[0074] The syringe system 1 and the liquid 2 described above are prepared, and the liquid 2 is placed in the container 50. Before placing the liquid 2 in the container 50, it is preferable to move the gasket 30 to the distal side of the tubular member 10. Thereafter, pressure is applied to the liquid 2 placed in the container 50. The pressure can be applied by the method described above. Note that the pressurization of the liquid 2 may be performed by the pressurizing device 52 described above. Pressure is applied to the liquid 2 in the container 50 by the pressurization, and the liquid 2 can be filled into the lumen of the tubular member 10.

[0075] This configuration makes it possible to manufacture a prefilled syringe that can fill the inner cavity of the tubular member 10 with the liquid 2 contained in the container 50 through the inlet 20 of the tubular member 10. With the prefilled syringe manufactured in this way, even if the amount of liquid 2 that was previously filled is small, the inner cavity of the tubular member 10 can be refilled with the liquid 2 when the injection needle is inserted into the treatment area or when the catheter is inserted, without removing the tubular member 10 from the injection needle or catheter.

[0076] The method may include a step of packaging the syringe system after the step of filling the inner cavity of the tubular member 10 with the liquid 2 from the container 50. Furthermore, the method may further include a step of refilling the container 50 with the liquid 2 after the step of filling the inner cavity of the tubular member 10 with the liquid 2 from the container 50 and before the step of packaging the syringe system. [Explanation of symbols]

[0077] 1: Syringe system 2: Liquid 10: Cylindrical member 11: First area 12: Second area 13: Reduced diameter section 20: Inlet 30: Gasket 40: Press 50: Container 51: Spout 52: Pressure device 60: Tube 70: First Control Section 71: Lid 72: Operation section 80: Second control section 90: Processing unit 91: Sensor 92: Sensor

Claims

1. a cylindrical member having a distal end and a proximal end, and an injection port formed proximal to the distal end and distal to the proximal end; a gasket disposed in the inner cavity of the tubular member; a plunger disposed in the inner cavity of the tubular member and connected to the gasket; a container connected to the inner cavity of the tubular member via the injection port so as to be able to communicate with the inner cavity of the tubular member; The liquid contained in the container can be filled into the inner cavity of the cylindrical member through the filling port, A syringe system comprising an arithmetic processing unit that measures the amount of liquid filled in the inner cavity of the tubular member and the amount of liquid placed in the container, and calculates the amount of liquid to be filled from the container into the inner cavity of the tubular member based on the measured amount of liquid filled in the inner cavity of the tubular member and the amount of liquid placed in the container.

2. The syringe system according to claim 1 , wherein the container is provided with a pressurizing device.

3. The syringe system according to claim 1 or 2, wherein the cylindrical member has a first region and a second region located proximal to the first region and having an outer diameter larger than that of the first region.

4. The syringe system according to claim 3 , wherein the injection port is formed in the second region.

5. The second region extends from a proximal end of the first region and has a tapered portion whose lumen becomes smaller toward a distal side, The syringe system according to claim 3 , wherein the injection port is formed in the reduced diameter portion.

6. The syringe system according to claim 3 , wherein the injection port is formed in the first region.

7. 7. The syringe system according to claim 1, further comprising a tube connecting the injection port and the container.

8. 8. The syringe system according to claim 7, wherein at least one of the injection port and the tube has a first control section capable of blocking communication between the inner cavity of the tubular member and the container.

9. The syringe system according to claim 8 , wherein the first control unit includes a lid portion capable of blocking communication between the inner cavity of the cylindrical member and the container, and an operating unit for operating to open and close the lid portion.

10. The tube is provided with a stopcock; A syringe system including two or more of the containers, The syringe system according to any one of claims 7 to 9, wherein the inner cavity of the cylindrical member and two or more of the containers are communicably connected via the tube and the stopcock.

11. 11. The syringe system according to claim 1, wherein at least one of the cylindrical member and the container has a marking formed thereon by a laser.

12. The syringe system according to any one of claims 1 to 11, wherein the liquid is a cell suspension.

13. Providing a syringe system according to any one of claims 1 to 12 and a liquid; placing a liquid in the container; decompressing the lumen of the tubular member by moving the gasket from a distal side toward a proximal side of the tubular member; and filling the liquid from the container into the inner cavity of the cylindrical member by the reduced pressure.

14. Providing a syringe system according to any one of claims 1 to 12 and a liquid; placing a liquid in the container; applying pressure to the liquid; and filling the liquid from the container into the lumen of the tubular member by applied pressure.

15. The method for manufacturing a prefilled syringe according to claim 13 or 14, further comprising a step of packaging the syringe system after the step of filling the liquid from the container into the inner cavity of the cylindrical member.

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