Filling guide for injecting liquid medicine into liquid medicine injection device, and liquid medicine injection device having same

Abstract

The present invention provides a filling guide for a liquid medicine injection device, having one side to which a coupling member connected to the end of a tube of a liquid medicine injection device is attachably / detachably coupled, the filling guide comprising: a first space part (430) formed in a circular recess shape on the surface of the one side thereof; a cylindrical member (480) protruding in a circular shape from the other side thereof such that a second space part (470) is formed therein; a partition wall (440) positioned between the first space part and the second space part; an injection passage (450) formed in the center of the partition wall so as to allow the first space part to communicate with the second space part, thereby serving as a passage through which liquid medicine is injected; and a sealing rubber member (430a) and an air filter (430b), which are inserted into the first space part (430).

Description

A filling guide for injecting a drug solution into a drug solution injection device and a drug solution injection device equipped with the same

[0001] The present invention relates to a technology for completely filling the cartridge and the inside of the passage with a drug solution while simultaneously removing internal air from the entire passage including the cartridge during the process of filling the cartridge with a drug solution in the inside of a drug solution injection device.

[0002] For diabetes treatment, insulin infusion devices are used to inject medication into the patient's body. While these devices are sometimes used by medical professionals, such as doctors and nurses, they are often used by the patient themselves or by their guardians. Diabetics, especially those with pediatric diabetes, require the injection of medications like insulin at regular intervals. Therefore, patch-type medication infusion devices, which are attached to the body for a set period of time, are being developed. These devices can be used in a patch-like manner on the patient's body for a set period of time.

[0003] It is important for a drug injection device to inject the drug in a precise amount. To achieve this, the device must have a structure that precisely dispenses small amounts of the drug in a precise amount. Furthermore, it is desirable to manufacture the device in a compact size that can be easily attached to the human body. Furthermore, a drug injection device can be comprised of a combination of a rechargeable module that can be reused repeatedly and a disposable module that is replaced after use. When the drug in the internal cartridge (reservoir) is completely depleted, the disposable module must be replaced and the internal cartridge must be refilled with new drug.

[0004] Looking at this drug filling process, the drug is filled into the cartridge using a syringe needle, but since air exists in the cartridge and the path where the drug is to be filled in the drug injection device, it is important to effectively remove this air and fill the cartridge and the path with the drug. However, since the existing drug injection devices have a structure that simply injects the drug into the path where air exists, there was a problem in that the air in the cartridge and the path could not be completely removed during the drug injection process.

[0005] The purpose of the present invention is to provide a structure that effectively discharges air existing in a cartridge and a passage during the process of filling a medicine into a medicine injection device and completely fills the inside of the passage with the medicine.

[0006] The present invention provides a filling guide for a chemical injection device, comprising: a first space (430) detachably connected to one side of a connecting member connected to the end of a tube of a chemical injection device, the first space having a circular groove shape on the surface of the one side; a cylindrical member (480) protruding in a circular shape from the other side to form a second space (470) therein; a partition wall (440) positioned between the first space and the second space; an injection passage (450) formed at the center of the partition wall to connect the first space and the second space and serve as a passage through which a chemical is injected; and a sealing rubber member (430a) and an air filter (430b) inserted into the first space (430).

[0007] The present invention provides a drug injection device comprising: a reservoir in which a drug is stored; a piston-check valve module for supplying the drug stored in the reservoir to the inside and discharging it to the outside by a piston reciprocating motion; a first check valve (CV1) for allowing the drug to move only from the reservoir to the piston-check valve module and preventing it from moving in the opposite direction; a filling guide according to claim 1; and a coupling member connected to the end of a tube of the drug injection device and coupled to the filling guide.

[0008] A drug injection port (CP) formed on the rear of the drug injection device and into which a syringe needle is inserted when filling the reservoir with the drug; an imaginary vertical line that is perpendicular to the rear of the drug injection device and passes through the drug injection port (CP) is formed to pass through between the first check valve (CV1) and the reservoir (230) inside the drug injection device.

[0009] It further includes a connector (240) that connects the reservoir and the piston-check valve module to deliver the liquid, and the end of the syringe needle inserted into the liquid injection port (CP) is located in the connector.

[0010] The present invention provides a method for filling a medicine with a medicine injection device, comprising: a first step of inserting a syringe into a second space of a cylindrical member of the filling guide and pulling the syringe piston to remove air inside a reservoir and a flow path; a second step of inserting the syringe needle into the medicine injection port and filling the reservoir with the medicine inside the syringe; and a third step of inserting a syringe into the second space of the cylindrical member of the filling guide and pulling the syringe piston to discharge the medicine inside the reservoir into the flow path and fill the flow path with the medicine.

[0011] The present invention enables the complete removal of air inside a cartridge and a passage during the process of filling a drug solution into a drug solution injection device, and the complete filling of these spaces with the drug solution.

[0012] Figures 1 and 2 are front and rear views of the drug injection device according to the present invention.

[0013] Figure 3 is a view showing the reusable module and the disposable module separated from the liquid injection device according to the present invention.

[0014] Figure 4 is an exploded perspective view of the reuse module of the liquid injection device according to the present invention.

[0015] Figure 5 is an exploded perspective view of a disposable module in a liquid injection device according to the present invention.

[0016] Figures 6 to 9 are drawings showing the internal structure of a liquid injection device according to the present invention and the operation of a piston check valve module.

[0017] Figures 10 and 11 are front and rear perspective views of the coupling member of the drug injection device according to the present invention.

[0018] Figures 12 and 13 are front and rear perspective views of the filling guide of the liquid injection device according to the present invention.

[0019] Figure 14 is an exploded perspective view of some parts of the filling guide of the liquid injection device according to the present invention.

[0020] Figures 15 and 16 show the internal structure of the filling guide of the present invention.

[0021] Figures 17 and 18 are front and rear perspective views of the filling guide and the coupling member of the liquid injection device according to the present invention.

[0022] Figure 19 sequentially illustrates the process of filling a drug solution into the drug solution injection device according to the present invention.

[0023] Figure 20 shows the internal structure of a part of a drug injection device according to the present invention, showing the location where drug filling takes place.

[0024] Hereinafter, embodiments of the present invention will be described in detail with reference to the attached drawings so that those skilled in the art can easily implement the present invention. However, the present invention may be implemented in various different forms and is not limited to the embodiments described herein.

[0025] Hereinafter, the present invention will be described in detail with reference to the attached drawings.

[0026] In the following description, the forward / retreat etc. are expressed as 'forward' when the moving body or piston, which is a component of the device of the present invention, moves upward as seen in the drawing, and 'retreat' when the moving body or piston moves downward as seen in the drawing, but this is only an expression for convenience of explanation and does not limit the scope of the rights of the present invention. In addition, the 'up and down' direction used in the following description is a direction based on the drawing for convenience of explanation, and such direction does not limit the scope of the rights of the invention.

[0027] Referring to FIGS. 1 to 3, a drug injection device according to one embodiment of the present invention is formed by combining a rechargeable module (100) that can be reused repeatedly and a disposable module (200) that is replaced after use, and includes a tube (T) that is a path for discharging the drug inside the drug injection device to the outside. The disposable module is provided with an attachment member (not shown) on the rear side for attaching it to the user's body, and a coupling member (300) is provided at the end of the tube, and the coupling member (300) is coupled to a needle (not shown) that has been inserted into the body. With this structure, the drug inside the drug injection device is injected into the body through the tube (T), the coupling member (300), and the needle (not shown, inserted into the body). The coupling member (300) is coupled to a filling guide (400) to fill the drug inside the device, which will be described in detail below.

[0028] A separation button (B) for separating the reusable module and the disposable module from the drug injection device is provided on the upper surface, and the reusable module and the disposable module can be separated from each other by pressing the separation button. Fig. 3 illustrates the separated appearance. In Fig. 2, the unexplained symbol CP indicates a location for filling the drug using a syringe, and for convenience, it is referred to as a "drug injection port" (described below).

[0029] In this way, the present invention uses a reusable module (100) and a disposable module (200) in combination. To replace the disposable module, these modules must be separated from each other. However, with the miniaturization of the device, this separation operation is becoming more difficult. This advantage will be briefly described and further explained in the following sections.

[0030] [Structure of reusable and disposable modules]

[0031] Referring to Fig. 4, the structure of the reusable module (100) will be examined. The reusable module (100) has a structure that can be separated from the disposable module (200) using a separation button (B), and can be reused repeatedly. The reusable module (100) has an upper case (111) and a lower case (112), and inside these cases, a main PCB (114), a lower bracket (116), and an upper bracket (118) are provided. And, as a member accommodated by the upper bracket and the lower bracket, etc., it comprises a battery (120) that stores electric power, a solenoid (130) that receives electric power from the battery and generates magnetic force, a first moving body (140) that reciprocates up and down with the magnetic force generated by the solenoid, and a second moving body (150) that performs an up and down reciprocating motion linked to the up and down reciprocating motion of the first moving body and discharges the medicine stored in the disposable module (200). In addition, a lever (160) that links the up and down reciprocating motions of the first moving body and the second moving body is provided.

[0032] In Fig. 5, a disposable module (200) of a drug injection device according to the present invention is illustrated. The disposable module (200) includes an inner case (210) and an outer case (220) coupled on top of the inner case, and includes a reservoir (230) for storing a drug as a member provided inside the cases, a piston-check valve module (250) for discharging a certain amount of the drug, and a connector (240) for connecting the reservoir and the piston-check valve module to transmit the drug. The drug stored in the reservoir (230) is transmitted to the piston-check valve module (250) via the connector (240).

[0033] [Quantitative Control Structure]

[0034] Referring to FIGS. 6 to 9, a structure for discharging a liquid in a state where the reusable module (100) and the disposable module (200) are combined will be described.

[0035] The first moving body (140) of the above reusable module (100) is composed of a central axis (142) and an outer member (144). The entire first moving body (140) may be composed of magnets, or it may be located at the center and only the central axis (142) may be composed of magnets. The first moving body moves up and down by the magnetic force generated by the solenoid (130). In addition, the lever (160) is a member whose left and right ends move up and down based on a pivot axis (162) that is arranged approximately horizontally and is located at a certain point between the two ends.

[0036] In the up-and-down reciprocating motion described here, the meaning of “up-and-down direction” refers to the upward and downward directions as seen in the drawing of Fig. 6, and refers to the direction parallel to the longitudinal direction of the central axis (142).

[0037] The upper end of the central axis (142) of the first moving body (140) is coupled with one end (164) of the lever (160), and the other end (166) of the lever (160) is coupled to the second moving body (150). The pivot axis (162) may be positioned closer to the other end rather than at the exact center point between the two ends, and in the present invention, the pivot axis (162) is positioned at a point closer to the second moving body.

[0038] By configuring the position of the pivot axis to be biased toward the second moving body in this way, there is an advantage in that small amount of liquid can be controlled and the second moving body can be reciprocated with a relatively small force on the solenoid side. That is, by making the vertical reciprocating movement distance of the second moving body smaller than the vertical reciprocating movement distance of the first moving body, the liquid discharged from the quantitative control space (251) to be described below can be controlled in a smaller amount, and also, by the lever principle, the second moving body can be operated with a smaller force than the force required for the vertical movement of the first moving body.

[0039] When the first moving body (140) moves forward (moves upward), the second moving body (150) moves backward (moves downward) (as shown in FIG. 6), and when the first moving body (140) moves backward (moves downward), the second moving body (150) moves forward (moves upward) (as shown in FIG. 8).

[0040] Figures 6 and 8 show the overall operation of the first and second moving bodies, and Figures 7 and 9 are enlarged detailed drawings for explaining the operation structure of the piston-check valve module (250) of the disposable module (200) in Figures 6 and 8.

[0041] First, the structure of the piston-check valve module (250) of the disposable module (200) will be examined. The piston-check valve module (250) has a quantitative control space (251) where a certain amount of chemical liquid is supplied and received, an injection passage (252) through which the chemical liquid is injected is formed in the horizontal direction of the quantitative control space (251), and a discharge passage (253) through which the chemical liquid is discharged is formed on the upper side of the quantitative control space (251). The quantitative control space (251) is a cylindrical space formed in the vertical direction, and a piston (255) moves up and down reciprocally inside the quantitative control space (251). A circular piston lower member (256) formed with an increasing radius is provided at the lower portion of the piston (255). The injection passage (252) is provided inside the connector (240).

[0042] And, the piston lower member (256) is coupled to the upper end of the second moving body (150) of the reuse module (100) and moves up and down together with the second moving body, and as a result, the piston moves up and down. The piston lower member (256) is coupled to the upper end of the second moving body (150) of the reuse module (100) by a coupling member (M) located inside the piston lower member (256). When the first moving body (140) moves up and down by the operation of the solenoid (130) of the reuse module (100), the second moving body (150) moves up and down accordingly, and as a result, the piston (255) moves up and down inside the quantitative control space (251).

[0043] At this time, when the piston (255) moves down, the quantitative control space (251) is opened, and an injection process is performed in which the chemical liquid stored in the reservoir (230) is injected into the quantitative control space through the injection passage (252) (Figs. 6 and 7). Then, when the piston (255) moves up, the chemical liquid in the quantitative control space (251) is discharged to the outside through the discharge passage (253) and discharged to the tube (T in Fig. 1) (Figs. 8 and 9). The piston also functions as a kind of check valve during the chemical liquid discharge process. When looking at the process in which the chemical liquid is discharged to the outside from the quantitative control space, the piston (255) has a structure in which the injection passage (252) is closed by the outer surface of the side surface, so that the chemical liquid does not move to the injection passage (252) on the reservoir side, and also functions as a kind of check valve.

[0044] In addition, first and second check valves (CV1, CV2) are arranged in each of the injection passage (252) through which the chemical liquid is injected into the quantitative control space (251) and the discharge passage (253) through which the chemical liquid from the quantitative control space (251) is discharged to block reverse flow. The first check valve (CV1) allows the chemical liquid to move only from the connector (240) to the quantitative control space (251) and prevents it from moving in the opposite direction, and the second check valve (CV2) allows the chemical liquid to move only from the quantitative control space (251) toward the tube and prevents it from moving in the opposite direction.

[0045] The present invention has developed a compact structure in which two check valves are configured in a direction perpendicular to each other in an injection passage and a discharge passage together with a quantitative control space using a piston as described above, and these are configured as a single integrated module, thereby drastically reducing the size of the product.

[0046] [Liquid filling structure]

[0047] Hereinafter, a method for filling a drug solution into the drug injection device of the present invention will be described with reference to FIGS. 10 to 20. The present invention relates to a structure for filling a drug solution into the internal reservoir (230) and flow path of a disposable module when using the drug injection device. The drug solution filling can be applied both when the device is first used and when it is reused.

[0048] As described in FIGS. 1 to 3, the medicinal solution stored in the reservoir (230) inside the medicinal solution injection device is injected into the human body and consumed through the tube (T) and the coupling member (300). When the medicinal solution inside the reservoir (230) is completely exhausted, the disposable module (100) is separated from the reusable module (200) and replaced with a new disposable module. Before the new disposable module is coupled to the reusable module, the medicinal solution is filled into the internal reservoir (230) and the flow path of the disposable module, as described below. That is, after the medicinal solution is filled into the disposable module, it is coupled to the reusable module.

[0049] The present invention is characterized in that air existing inside the tube is first discharged to the outside before filling the liquid, and for this purpose, a joining member (300) and a filling guide (400) are included.

[0050] Referring to FIGS. 10 and 11, the coupling member (300) is a member that is coupled to the end of the tube and is coupled to a needle (not shown) attached to the human body to serve as a passage for injecting the drug into the human body, and is also a member that is used in the process of refilling the drug into the reservoir. The coupling member (300) is provided with a front body (310) into which the tube is inserted at the front, and wing parts (320) that exert elastic force when fastened to the filling guide are provided on both rear sides of the front body. An opening (350) that connects the inside and the outside of the tube is positioned on the lower surface of the front body (310), and a circular sealing protrusion (360) is provided surrounding the opening.

[0051] Referring to FIGS. 12 and 13, the filling guide (400) is a member to which the connecting member (300) is detachably connected, and a front connecting portion (410) to which the front body (310) of the connecting member is connected and a wing connecting portion (420) to which the wing portion (320) of the connecting member is connected are formed on the upper surface (the surface facing the lower surface of the connecting member (300). In addition, a first space portion (430) having a circular groove shape is formed in a sunken shape in the front connecting portion (410). A sealing rubber member (430a) and an air filter (430b) to be described below are inserted into the first space portion (430). A cylindrical cylindrical member (480) having a second space portion (470) therein is provided on the lower surface of the filling guide. Between the first space (430) and the second space (470), a partition wall (440) separates the first space (430) and the second space (470), and an injection passage (450) having a relatively small diameter and communicating the first space (430) and the second space (470) is formed in the center of the partition wall. The injection passage (450) is a passage through which a drug injected from the outside passes and is filled into the reservoir. The second space (470) inside the cylindrical member (480) is a space into which an external syringe is inserted during the drug filling process.

[0052] The first space (430) is a space into which a sealing rubber member (430a) and an air filter (430b) are inserted, and the second space (470) is a space into which a syringe is inserted in the filling process described below (described in FIG. 19). In the drug filling process, the sealing rubber member (430a) seals the inside and outside when the sealing protrusion (360) of the connecting member (300) comes into contact with it. The air filter (430b) is located on the inside of the sealing rubber member (430a) and is a member that allows only gas to pass through and not the drug to pass through. By using this, it is possible to remove air in the reservoir and the flow path during the drug filling process. In addition, when the drug (insulin) is filled throughout the flow path, the drug is filled only up to the air filter and no more drug is filled. The above air filter is made of a material that allows only air to pass through but not the chemical liquid, and examples of materials that can be used include polytetrafluoroethylene (PTFE), Tyvek, Kynar, and polyvinylidene fluoride (PVDF).

[0053] Fig. 14 shows a perspective view of the sealing rubber member (430a) and the air filter (430b) separated from the filling guide (400), Fig. 15 shows the filling guide (400) with the sealing rubber member (430a) and the air filter (430b) removed, and Fig. 16 shows a cross-sectional view of the XY portion of Fig. 15.

[0054] Figures 17 and 18 are front and rear perspective views of the sealing rubber member (430a) being joined with the sealing projection (360) of the connecting member (300) to seal the path through which the liquid is injected from the outside by connecting the filling guide and the connecting member.

[0055] Figures 19 (a) to (c) sequentially illustrate the process of filling a drug solution into the interior of a drug injection device. A syringe is used in the drug solution filling process, and the device is configured to enable filling using a commonly used syringe.

[0056] Looking at the first filling process illustrated in (a) of Fig. 19, first, the inlet of a syringe (not shown) is inserted into the second space (470) of the cylindrical member (480) of the filling guide (400) to remove air inside the cartridge (reservoir) and the passage. At this time, a syringe without a needle is used. That is, after the syringe inlet is positioned in the injection passage (450) inside the cylindrical member (480), the piston is pulled to remove air inside the reservoir and the passage. As the volume of the reservoir and the passage contracts, the internal air escapes to the outside.

[0057] Figure 19 (b) illustrates a two-step filling process. A drug solution is placed inside a syringe, and a needle is mounted on the syringe inlet. Then, the syringe needle (not shown) is inserted into the drug injection port (CP in Figure 2) located at the rear of the disposable module (200), and the syringe piston is pushed to fill the drug solution inside the syringe into the drug injection device. During this process, the drug solution is filled into the drug injection device reservoir (230).

[0058] At this time, the location where the syringe needle is located is located in the path between the reservoir (230) and the piston (255). Referring to Fig. 6, the syringe needle is located in the connector (240). That is, the syringe needle is inserted into the connector (240, between the reservoir (230) and the piston-check valve module) inside the drug injection device through the drug injection port (CP). Fig. 20 shows the internal structure of a part of the drug injection device according to the present invention, and shows the location where the drug is filled from a different angle from Fig. 6. In the drawing, CP-1 is a location inside the drug injection device corresponding to the drug injection port (CP).

[0059] And, the drug solution injected from the syringe is injected into the reservoir (230) and fills the reservoir. And, the injected drug solution is filled only up to the first check valve (CV1 in Fig. 7) in the direction of the piston-check valve module. This is because the pressure may be weak for the drug solution injected from the syringe to enter through the first check valve. In this way, the place where the drug solution is filled in the second filling step is from the first check valve (CV1) to the reservoir (230). The drug solution is filled in the path from the first check valve toward the tube (T) in the third filling step, which will be described below.

[0060] Looking at the three-step filling process illustrated in (c) of Fig. 19, it is a process of filling the flow path with a drug solution using a syringe that does not include a needle, and the flow path is filled as the drug solution stored inside the reservoir is discharged. After positioning the syringe inlet in the injection passage (450) inside the cylindrical member (480) and pulling the piston, the drug solution filled in the reservoir (230) in the second filling step is discharged into the flow path by negative pressure. That is, the drug solution inside the reservoir is discharged through the flow path while passing through the first check valve, the piston-check valve module, and the second check valve, and in this process, the drug solution is filled throughout the flow path. However, the drug solution is filled only up to the error filter (460) and no more drug solution is filled. To this end, the function of an air filter that only passes air is utilized.

[0061] The present invention removes air from the reservoir and the entire flow path and fills the reservoir with a liquid through the processes of (a) to (c) of FIG. 19. Arrows A, B, and C in FIG. 19 indicate the positions where the syringe is inserted during this process.

[0062] The present invention completely removes the air inside the cartridge and the passage during the process of filling the drug solution into the drug solution injection device, and completely fills these spaces with the drug solution. In addition, the present invention creates a syringe insertion structure that enables sealing while using a regular syringe as is in the filling guide, and applies an air filter to allow only gas to pass through, thereby enabling the removal of air inside the cartridge while allowing the entire passage to be filled with the drug solution, insulin.

[0063] Although the preferred embodiments of the present invention have been described in detail above, the scope of the present invention is not limited thereto, and various modifications and improvements made by those skilled in the art using the basic concept of the present invention defined in the following claims also fall within the scope of the present invention.

Claims

1. As a filling guide for injecting the drug into the drug injection device, A connecting member connected to the tube end of the above-mentioned liquid injection device is detachably connected to one side, A first space portion (430) formed in a circular groove shape on the surface of the above one side; A cylindrical member (480) that protrudes in a circular shape from the other side and forms a second space (470) inside; A partition wall (440) located between the first space and the second space; An injection passage (450) formed in the center of the above bulkhead and connecting the first space and the second space to serve as a passage through which the drug is injected; and A filling guide for a liquid injection device including a sealing rubber member (430a) and an air filter (430b) inserted into the first space portion (430).

2. In paragraph 1, A filling guide for a chemical injection device, characterized in that the air filter is placed between a sealing rubber member and a bulkhead and allows air to pass through but does not allow chemical to pass through.

3. Reservoir where the drug is stored; A piston-check valve module that supplies the drug solution stored in the reservoir to the inside and discharges it to the outside by the piston reciprocating motion; A first check valve (CV1) that allows the liquid to move only from the reservoir to the piston-check valve module and prevents it from moving in the opposite direction; Filling guide of paragraph 1; and A liquid injection device comprising a coupling member connected to the tube end of the liquid injection device and coupled to the filling guide.

4. In paragraph 3, A drug injection port (CP) formed on the rear of the drug injection device and into which a syringe needle is inserted when filling the reservoir with drug; A drug injection device characterized in that an imaginary vertical line perpendicular to the rear of the drug injection device and passing through the drug injection port (CP) passes between the first check valve (CV1) and the reservoir (230) inside the drug injection device.

5. In paragraph 4, It further includes a connector (240) that connects the reservoir and the piston-check valve module to deliver the liquid, A drug injection device characterized in that the tip of the syringe needle inserted into the above drug injection port (CP) is located in the connector.

6. A method for filling a drug solution using the drug solution injection device of Article 4, A first step of inserting a syringe into the second space of the cylindrical member of the above-mentioned filling guide and pulling the syringe piston to remove air inside the reservoir and the flow path; A second step of inserting the syringe needle into the drug injection port and filling the drug inside the syringe into the reservoir; A method for filling a medicine in a medicine injection device, comprising: a third step of inserting a syringe into the second space of the cylindrical member of the above-mentioned filling guide, pulling the syringe piston, and filling the medicine in the passage by releasing the medicine inside the reservoir into the passage.

7. In paragraph 6, A method for filling a liquid in a liquid injection device, characterized in that in the third step, the liquid inside the reservoir is filled into the flow path, but is filled only up to the air filter.

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