Safety control mechanism for drug injection system

Abstract

To provide a safety control mechanism for a drug injection system.SOLUTION: A drug injection system includes a needle output mechanism 10, a drug storage module, and a control unit. A safety control mechanism includes a contact end cap slidably attached in a casing and a confirmation switch electrically connected to the control unit. The contact end cap can be forcibly made to progress in the casing in order to release a needle output element. When the contact end cap is pressed to an end position, the confirmation switch is actuated to switch the control unit into an injection preparation state.SELECTED DRAWING: Figure 4

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application is a divisional application of Japanese Patent Application No. 2023-579383, which is the Japanese national stage of PCT / CN2022 / 125386 filed on October 14, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates to the field of drug injection technology, and in particular to safety control mechanisms for drug injection systems. [Background technology]

[0003] Conventionally, a drug injection system for injecting a drug solution subcutaneously into a human body mainly uses an injection mechanism that can be operated manually or electrically, in which a drug container is connected, a needle set of the injection mechanism is inserted into the human body, and the hard needle of the needle set is pulled out while the soft needle of the needle set is left pierced into the skin of the human body, and the drug solution is then manually or electrically injected into the subcutaneous tissue of the human body through the soft needle pierced into the human body.

[0004] The aforementioned injection mechanism has a composite needle set including a soft needle and a hard needle, and provides a component for subcutaneous injection into the human body. However, the conventional injection mechanism is operated by a complicated needle output operation mechanism, so that the needle set is inserted into the human body with the soft needle sleeved around the hard needle, and then the hard needle is withdrawn, leaving the soft needle in the human body. The operation of the needle set is relatively cumbersome.

[0005] In addition, in view of the above-mentioned problems of the conventional injection mechanism, after the adapter mechanism combined with the injection mechanism is connected to the drug storage mechanism, the transport path of the drug liquid is also relatively complicated. In addition, the combined structure of each mechanism in the drug injection system also makes it difficult to provide an ideal injection method. In particular, the drug injection system has a problem of insufficient safety performance. It is necessary to further optimize the needle output mechanism in the drug injection system. Summary of the Invention

[0006] The main objective of the present invention is to provide a safety control mechanism for a drug injection system to solve the problem of insufficient safety performance of the conventional drug injection system.

[0007] The technical solution proposed by the present invention is a safety control mechanism for a drug injection system, the drug injection system comprising a needle output mechanism, a drug storage module for storing a drug solution, and a control unit. The needle output mechanism includes a casing, a puncture assembly assembled in the casing, and a needle output operation assembly assembled in the casing for operating the puncture assembly. A needle output element of the needle output operation assembly is movable and lockable in the casing. The safety control mechanism comprises a contact end cap mounted in the casing and movable within a movement stroke. A portion of the contact end cap protrudes from the casing. The contact end cap can be forced into the casing to release the needle output element from a locked state.

[0008] The present invention further proposes a technical solution in a safety control mechanism for a drug injection system, the drug injection system comprising a control unit and a drug storage module for storing a drug solution. The safety control mechanism comprises a contact end cap and a confirmation switch. The contact end cap is mounted in a casing and movable within a movement stroke. A portion of the contact end cap protrudes from the casing. The confirmation switch is disposed at an end position of the movement stroke of the contact end cap and is electrically connected to the control unit. When the contact end cap is pushed back to the end position of the movement stroke, the contact end cap activates the confirmation switch.

[0009] In the safety control mechanism of the drug injection system configured in this manner, the contact end cap is movable within a moving stroke within a casing of the needle output mechanism of the drug injection system, a portion of the contact end cap protrudes from the casing, and the contact end cap can be forced into the casing to release the needle output element from the locked state. Therefore, it is possible to reliably prevent the piercing assembly from piercing before the needle output mechanism of the drug injection system is properly unlocked, and a good safety control function can be provided for the drug injection system.

[0010] The safety control mechanism further includes a confirmation switch disposed at the end of the stroke of the contact end cap, the confirmation switch being electrically connected to the control unit, and the confirmation switch can be activated when the contact end cap is pressed to retract to the end position, so that the confirmation switch can send a confirmation signal to the control unit, switch the control unit to an injection preparation state, and activate the drug injection system to inject the drug solution, thus improving the safety performance of the drug injection system. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 is a schematic perspective view of one embodiment of a needle output mechanism of a pharmaceutical injection system of a safety control mechanism of the pharmaceutical injection system of the present invention. [Diagram 2] FIG. 2 is a schematic exploded perspective view of the embodiment of the needle output mechanism shown in FIG. [Diagram 3] FIG. 3 is a schematic top view showing the combination of the needle force element and the rotation element of the embodiment of the needle force mechanism shown in FIG. [Figure 4] FIG. 4 is a schematic cross-sectional side view of the embodiment of the needle output mechanism shown in FIGS. [Diagram 5] FIG. 5 is a schematic cross-sectional side view of another aspect of the embodiment of the needle output mechanism shown in FIGS. [Figure 6] FIG. 6 is a schematic perspective view of one embodiment of an injection pathway module of a drug injection system of a safety control mechanism of the drug injection system of the present invention. [Figure 7] FIG. 7 is a schematic exploded view of the embodiment of the infusion pathway module shown in FIG. [Figure 8] FIG. 8 is a schematic exploded perspective view of an adapter mechanism for the embodiment of the infusion pathway module shown in FIG. [Figure 9] 9 is a schematic exploded perspective view of another view of the adapter mechanism of the embodiment of the infusion pathway module shown in FIG. [Figure 10] FIG. 10 is a schematic partial cross-sectional view of the embodiment of the infusion pathway module shown in FIG. [Figure 11] FIG. 11 is a schematic perspective view of one embodiment of the safety control mechanism for the drug injection system of the present invention. [Figure 12] FIG. 12 is a schematic exploded perspective view of the embodiment of the drug injection system shown in FIG. [Figure 13] FIG. 13 is a schematic exploded perspective view of a drug storage module of the embodiment of the drug infusion system shown in FIGS. [Figure 14] FIG. 14 is a schematic partial cross-sectional view of the combined drug storage module and infusion pathway module shown in FIGS. [Figure 15] FIG. 15 is a schematic, partially exploded perspective view of a drive module of the embodiment of the drug injection system shown in FIGS. [Figure 16] FIG. 16 is a schematic top view of the drive module shown in FIG. 15 with the housing cover removed. [Figure 17] FIG. 17 is a schematic top view of the embodiment of the drug injection system shown in FIGS. 11 and 12 with the housing cover and other components removed. [Figure 18] FIG. 18 is a schematic perspective view of a motor in combination with a transmission assembly of a drive module which connects with the piston rod of the adapter mechanism shown in FIGS. 15 to 17. [Figure 19] FIG. 19 is a schematic operational perspective view of a motor in combination with a transmission assembly of a drive module connecting with a piston rod of the adapter mechanism shown in FIGS. 15 to 17. [Figure 20] FIG. 20 is a schematic diagram (1) of an embodiment of a drug injection system showing the needle output mechanism performing a needle output operation. [Figure 21] FIG. 21 is a schematic diagram (2) of an embodiment of a drug injection system showing the needle output mechanism performing a needle output operation. [Figure 22] FIG. 22 is a schematic diagram of an embodiment of a drug injection system (3) showing the needle output mechanism performing a needle output operation. [Figure 23] FIG. 23 is a schematic diagram (1) of an embodiment of a drug injection system showing the drive mechanism that drives the piston rod to deliver the drug fluid. [Figure 24] FIG. 24 is a schematic diagram (2) of an embodiment of a drug injection system showing the drive mechanism that drives the piston rod to deliver the drug solution. [Diagram 25] FIG. 25 is a schematic diagram (1) of an embodiment of a drug injection system showing the contact end cap of the needle output mechanism being pressed to unlock the needle output element. [Figure 26] FIG. 26 is a schematic diagram (2) of an embodiment of a drug injection system showing the contact end cap of the needle output mechanism being pressed to unlock the needle output element. [Figure 27] FIG. 27 is a schematic diagram of an embodiment of a drug injection system showing the needle output element of the needle output mechanism being depressed. [Explanation of symbols]

[0012] 1. Infusion pathway module; 2. Drug storage module; 3. Drive module 10 needle output mechanism; 11 casing; 111 base; 1111 first engagement hole; 1112 second engagement hole; 112 outer casing; 113 contact end cap; 1131 unlocking pressing portion; S moving stroke; 114 elastic element; 12 needle output operation assembly; 121 needle output element; L operation stroke; 1211 elongated rail groove; 1212 toothed drive portion; 12121 forward rotating rack segment; 12122 reverse rotating rack segment; 1213 engagement hook; 122 rotating element; 1220 screw hole; 1221 gear portion; 123 needle seat plug; 1231 receiving chamber; 1232 liquid injection chamber; 1233 connection port; 1234 seal portion; 1235 stop portion; 124 needle seat; 1241 screw portion; 13 puncture assembly; 131 Puncture needle; 132 conduit element; 1321 needle end attachment part 20 adapter mechanism; 21 adapter seat; 211 chemical inflow passage; 212 chemical outflow passage; 22 flow path switching valve; 221 one-way input valve portion; 222 one-way output valve portion; 23 piston barrel; 230 piston chamber; 231 connection end portion; 2311 chemical inflow port; 2312 chemical outflow port; 232 barrel open end portion; 24 piston rod 30 drug solution storage container; 31 container body; 32 container connector; 321 connector body; 3210 injection path; 3211 container connection end; 3212 injection connection end; 3213 injection end portion; 32131 injection branch path; 3214 injection plug; 32141 plug end 40 Outer cover 50 housing; 51 housing body; 52 housing cover; 53 power supply unit; 54 electrical connector; 55 insulating sheet; 56 contact sheet 60 control unit; 61 switch; 62 actuation switch; 63 confirmation switch; 64 counting element; 65 indicator light; 66 sound generator 70 Motor 80 transmission assembly; 81 drive wheel; 82 connecting rod; 83 drive element DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The technical means adopted by the present invention to achieve the intended objects of the present invention will be further described below with reference to the drawings and embodiments of the present invention.

[0014] The present invention relates to a safety control mechanism of a drug injection system. The drug injection system includes an injection path module 1, a drug storage module 2, and a driving module 3. The injection path module 1 includes a needle output mechanism 10 and an adapter mechanism 20. The drug injection system will be described below with reference to the drawings.

[0015] 1-5, there is disclosed one embodiment of a needle output mechanism 10. As can be seen in the drawings, the needle output mechanism 10 includes a casing 11, a needle output manipulation assembly 12, and a puncture assembly 13.

[0016] As shown in Figs. 1 to 5, the casing 11 has an assembly chamber. The needle output manipulation assembly 12 and the puncture assembly 13 are assembled in the assembly chamber of the casing 11. In this embodiment, the casing 11 includes a base 111 and an outer casing 112 provided around the base 111 in a sleeve shape. A contact end cap 113 movable within a movement stroke S and an elastic element 114 disposed between the outer casing 112 and the contact end cap 113 are attached to the rear side of the outer casing 112. As the elastic element, a coil spring, a leaf spring, or other elastic elements can be used. In this embodiment, a compression spring is used as the elastic element 114.

[0017] As shown in FIGS. 1 to 5 , the needle output manipulation assembly 12 is attached to the casing 11 and coupled to the puncture assembly 13. The needle output manipulation assembly 12 includes a needle output element 121, a rotating element 122, and a needle seat 124. The needle output element 121 is movably attached within the casing 11. The rotating element 122 is rotatably attached within the casing 11, and the rotating element 122 is adapted to be rotationally driven by the needle output element 121. The needle seat 124 is movably attached within the rotating element 122. The needle seat 124 is driven by the rotating element 122 and can move between a first position and a second position.

[0018] As shown in Figs. 1 to 5, the needle output element 121 is attached so as to move linearly within the casing 11, and is movable along the operation stroke L within the casing 11. The needle output element 121 is lockable at the start position of the operation stroke L and at the end position of the operation stroke L. The rotating element 122 is attached to the base 111 of the casing 11, and is driven to rotate forward and backward by the needle output element 121. In this embodiment, the needle output element 121 is formed as a button-type component, and the rotating element 122 is formed as a sleeve-type component. However, the shapes of the needle output element 121 and the rotating element 122 are not limited to this.

[0019] 1 to 5, a gear portion 1221 is provided at the upper end of the rotating element 122, and a toothed driving portion 1212 is provided inside the needle output element 121. The toothed driving portion 1212 may be connected to the gear portion 1221 or may be separated from the gear portion 1221. When the needle output element 121 is pressed, the rotating element 122 is driven to rotate in a forward rotation direction and then in a reverse rotation direction through the transmission between the meshed toothed driving portion 1212 and the gear portion 1221.

[0020] 1 to 5, the needle output element 121 has an elongated rail groove 1211, the length of which is defined as an operating stroke L, and the toothed drive unit 1212 includes a forward rotating rack segment 12121 and a reverse rotating rack segment 12122. The forward rotating rack segment 12121 and the reverse rotating rack segment 12122 are two different parts respectively arranged along the Z-axis of the elongated rail groove 1211 and are arranged on two opposite sides. The length of the forward rotating rack segment 12121 and the length of the reverse rotating rack segment 12122 are half of the operating stroke L. The gear portion 1221 of the rotating element 122 is arranged in the elongated rail groove 1211, and as the needle output element 121 moves along the operating stroke L, the gear portion 1221 of the rotating element 122 can mesh with either the forward rotating rack segment 12121 or the reverse rotating rack segment 12122, respectively, so that the rotating element 122 can be driven to rotate in the forward rotation direction and the reverse rotation direction.

[0021] As shown in FIG. 1 to FIG. 5, the needle output operation assembly 12 may further include a needle seat plug 123. The needle seat plug 123 is a soft member made of a rubber material or the like. The needle seat plug 123 is attached to the base 111 and adjacent to the back surface of the casing 11. The needle seat plug 123 has an accommodation chamber 1231, a liquid injection chamber 1232 arranged at the lower end of the accommodation chamber 1231, a connection port 1233 arranged on the side of the liquid injection chamber 1232 and communicating with the liquid injection chamber 1232, and a seal portion 1234 arranged at the lower end of the liquid injection chamber 1232 and exposed to the back surface of the casing 11. A stop portion 1235 is provided between the accommodation chamber 1231 and the liquid injection chamber 1232. The needle seat 124 is movably attached within the rotating element 122. The needle seat 124 is rotationally driven by the rotating element 122 and is vertically movable between the rotating element 122 and the needle seat plug 123.

[0022] 3 and 25 to 27, the needle output element 121 is attached in the base 111 and is movable within a distance of an operation stroke L. The needle output element 121 is locked to the base 111 at the start position and the end position of the operation stroke L, respectively, to be in a locked state. The elastic force of the elastic element 114 acts on the contact end cap 113, and a part of the contact end cap 113 protrudes from the rear surface of the outer casing 112. The contact end cap 113 can be forcibly inserted into the outer casing 112 to release the needle output element 121 located at the start position of the operation stroke L from the locked state.

[0023] As shown in Figs. 25 to 27, the base 111 has a first engagement hole 1111 (115) disposed at the start position of the operation stroke L and a second engagement hole 1112 (116) disposed at the end position of the operation stroke L. An engagement hook 1213 is provided at the rear end of the needle output element 121. The engagement hook 1213 can selectively engage with the first engagement hole 1111 or the second engagement hole 1112. The contact end cap 113 has an unlocking pressing portion 1131. When the contact end cap 113 is pushed into the outer casing 112, the unlocking pressing portion 1131 presses the engagement hook 1213 of the needle output element 121 to separate it from the first engagement hole 1111, thereby releasing the locked needle output element 121 from the locked state.

[0024] As shown in FIGS. 1 to 5, the puncture assembly 13 is mounted in the casing 11, and the puncture assembly 13 is operable between a needle output state and a needle retract state. The puncture assembly 13 includes a puncture needle 131 and a conduit element 132. The puncture needle 131 is connected to the needle seat 124 of the needle output manipulation assembly 12. The conduit element 132 is connectable to the puncture needle 131. In the needle output state, the puncture assembly 13 formed by combining the conduit element 132 and the puncture needle 131 is driven by the needle output manipulation assembly 12 to protrude at least a portion of the puncture assembly 13 from the casing 11. In the needle retract state, the puncture needle 131 moves upward together with the needle seat 124, causing the puncture needle 131 to retract.

[0025] As shown in Figures 4, 5 and 20 to 22, an upper portion of the puncture needle 131 of the puncture assembly 13 is connected to the needle seat 124, and a lower portion of the puncture needle 131 protrudes downward into the needle seat plug 123. The conduit element 132 is disposed inside the needle seat plug 123 and is provided around the lower portion of the puncture needle 131 in a sleeve-like manner. A needle end attachment portion 1321 is provided at the upper end of the conduit element 132, and the needle end attachment portion 1321 is provided at the lower end of the needle seat 124 in a sleeve-like manner. In the needle output state, the puncture assembly 13 formed by combining the conduit element 132 and the puncture needle 131 is operable to penetrate downward through the seal portion 1234 at the bottom of the needle seat plug 123. In the needle retracted state, the puncture needle 131 moves upward together with the needle seat 124 to retract the puncture needle 131, and the conduit element 132 remains. A portion of the conduit element 132 is disposed outside the casing 11 , protruding from the seal portion 1234 .

[0026] As shown in FIG. 1 to FIG. 5, the rotating element 122 and the needle seat 124 are connected via a screw. That is, the rotating element 122 has a screw hole 1220 formed therein, and the screw portion 1241 is provided on the outer peripheral side surface of the needle seat 124 and engages with the screw hole 1220 of the rotating element 122, so that the forward and reverse rotation of the rotating element 122 can drive the needle seat 124 to move up and down. In this embodiment, in order to further set the needle output element 121 to the operation stroke L, the needle output element 121 can first drive the rotating element 122 to rotate forward to drive the needle seat 124, and press the puncture assembly 13 to move downward and output the needle. Next, the needle output element 121 can drive the rotating element 122 to rotate reversely, and drive the needle seat 124 and the puncture needle 131 connected thereto to move upward to retract the needle, and keep a part of the conduit element 132 protruding from the casing 11.

[0027] The needle output mechanism 10 can be used in a syringe. With reference to Figures 3 to 5 and 20 to 27, when the needle output mechanism 10 is not in use, the puncture assembly 13 of the needle output mechanism 10 is hidden in the casing 11. When outputting a needle, the user places the back side of the needle output mechanism 10 facing the intended injection site of the human body, applies a pressing force to the casing 11, and retracts the contact end cap 113 on the back side of the casing 11 into the casing 11 by pressing, and the lock release pressing portion 1131 of the contact end cap presses the engagement hook 1213 of the needle output element 121 in a direction away from the first engagement hole 1111, thereby releasing the needle output element 121 located at the start position of the operation stroke L from the locked state until the back side of the casing 11 is attached to the intended injection site of the human body.

[0028] Then, when the needle output element 121 is pressed to move the needle output element 121 from the start position to the end position of the operation stroke L, the needle output element 121 first rotates the rotating element 122 in the forward rotation direction, and drives the needle washer 124 and the puncture assembly 13 formed by combining the conduit element 132 and the puncture needle 131 connected to the needle washer 124 from the needle washer plug 123 to pierce the human body. When the needle output element 121 further moves to the end position of the operation stroke L, the rotating element 122 is further rotated in the reverse rotation direction, and the needle washer 124 and the puncture needle 131 connected to the needle washer 124 are housed in the needle washer plug 123, while the conduit element 132 is retained. A part of the conduit element 132 is disposed outside the casing 11 while protruding from the needle washer plug 123. The conduit element 132 remains at the position where it pierces the human body. Meanwhile, the engagement hook 1213 of the needle output element 121 that has moved to the end position of the operating stroke L can engage with the second engagement hole 116 of the base 111 to keep the needle output element 121 in a locked state, allowing the user to inject the medicinal liquid without pressing the needle output element 121. After the injection of the medicinal liquid is completed and the needle output mechanism 10 is removed from the human body, the contact end cap 113 is pushed back by the elastic force of the elastic element 114, returns to its original position, and is attached around and outside the lower part of the puncture needle 131 to provide safety protection.

[0029] The conduit element 132 may be a soft needle or a soft tube such as a heat-shrinkable soft tube. However, the conduit element 132 is not limited thereto. Any element that is suitable for puncturing the human body in combination with the puncture needle 131, suitable for being left in the human body, and forms a flow path through which liquid flows into the human body is suitable for use as the conduit element 132.

[0030] 6 and 7, one embodiment of the infusion pathway module 1 is disclosed. As can be seen from the drawings, the infusion pathway module 1 includes a needle output mechanism 10 and an adapter mechanism 20. The structure of the needle output mechanism 10 has been disclosed above and will not be repeated below.

[0031] As shown in FIG. 7, FIG. 8 and FIG. 10, the adapter mechanism 20 includes an adapter seat 21, a flow path switching valve 22, a piston barrel 23 and a piston rod 24. The adapter seat 21 can be assembled to the side surface of the casing 11. The adapter seat 21 has a liquid medicine inlet 211 and a liquid medicine outlet 212. The flow path switching valve 22 is attached to the adapter seat 21, and the flow path switching valve 22 includes a one-way input valve portion 221 and a one-way output valve portion 222. The two ends of the piston barrel 23 are a connecting end 231 and a barrel opening end 232, respectively. The connecting end 231 is disposed in the adapter seat 21 and connected to the flow path switching valve 22. The barrel opening end 232 can protrude from the adapter seat 21. The piston barrel 23 has a piston chamber 230 formed therein. The connecting end 231 has a liquid medicine inlet 2311 and a liquid medicine outlet 2312 that communicate with the piston chamber 230. The liquid medicine inlet 2311 is connected to the one-way input valve section 221. The liquid medicine outlet 2312 is connected to the one-way output valve section 222. The piston rod 24 is assembled to the piston chamber 230 of the piston barrel 23 and protrudes from the adapter seat 21. The piston rod 24 can be driven to move linearly in the piston chamber 230 of the piston barrel 23. When the piston rod 24 moves rearward, the liquid medicine is drawn in one direction into the piston chamber 230 via the liquid medicine inlet passage 211 and the one-way input valve section 221. When the piston rod 24 moves forward, the liquid medicine in the piston chamber 230 is output in one direction to the liquid medicine outlet passage 212 via the one-way output valve section 222, and the liquid medicine for injection is input to the injection mechanism 10.

[0032] 7, 8 and 10, the piston rod 24 of the injection route module 1 may be operated manually, or the injection route module 1 may be driven to inject the medicinal liquid using a manual drive module 3 or an electric drive module 3 externally connected to the piston rod 24. In the injection route module 1, the injection operation of introducing the medicinal liquid into the injection mechanism 10 via the switching mechanism 20 is as described above, and will not be repeated below.

[0033] 11 to 12, the drug injection system includes the injection channel module 1, the drug storage module 2, and the driving module 3. The structure of the injection channel module 1 is as disclosed above, and will not be repeated below.

[0034] As shown in FIG. 12 to FIG. 14, the drug storage module 2 includes a drug solution storage container 30 and an outer cover 40. The drug solution storage container 30 includes a container body 31 and a container connector 32. The container body 31 can be filled with a drug solution inside. That is, the container body 31 is a member that can be filled with a drug solution in advance. Alternatively, the container body 31 is a part that is not originally filled with a drug solution, and a predetermined drug solution is injected into the container body 31 before use. The container connector 32 is assembled to the container body 31. The drug solution storage container 30 can be connected to the drug solution inflow path 211 of the adapter mechanism 20 of the injection path module 1 by the container connector 32. The outer cover 40 is provided in a sleeve shape around the drug solution storage container 30 and can be connected to the casing 11 of the needle output mechanism.

[0035] 12 to 14, a bag-shaped member, a bottle-shaped member, or the like for storing a liquid medicine can be used as the container body 31. In this embodiment, a bag-shaped member is used as the container body 31, but the present invention is not limited to this. A container connector 32 is connected to the container body 31. The container connector 32 has an injection path 3210 that communicates with the container body 31, and is connected to the liquid medicine inflow path 211 of the adapter mechanism 20 via the injection path 3210.

[0036] 12 to 14, container connector 32 includes a connector body 321. Connector body 321 includes a container connection end 3211 and an injection connection end 3212. Injection path 3210 extends from container connection end 3211 to injection connection end 3212, and is connected to container body 31 via container connection end 3211, and is connected to drug solution inflow path 211 of adapter mechanism 20 via injection connection end 3212.

[0037] As shown in Figs. 12 to 14, the connector body 321 may further include an injection end portion 3213. The injection end portion 3213 has an injection branch passage 32131 communicating with the injection passage 3210 and an injection plug 3214 attached to the injection branch passage 32131, and the injection plug 3214 seals the injection branch passage 32131. The injection plug 3214 has a plug end 32141 exposed to the outside of the connector body 321. The plug end 32141 is exposed at the back surface of the outer cover 40. Therefore, by piercing the plug end 32141 with a syringe, the medicinal solution to be added can flow into the container body 31 of the medicinal solution storage container 30 through the injection branch passage 32131 and the injection passage 3210.

[0038] As shown in FIG. 12 and FIG. 15 to FIG. 17, the drive module 3 is an electric drive module 3. The drive module 3 is detachably assembled to the injection path module 1. The drive module 3 includes a power supply unit 53 or can be connected to an external power supply. The drive module 3 includes a housing 50, a control unit 60, a motor 70, and a transmission assembly 80. The control unit 60, the motor 70, and the transmission assembly 80 are all mounted in the housing 50. The motor 70 is electrically connected to the control unit 60 and controlled by the control unit 60. The control unit 60 has a switch 61 exposed to the outside of the housing 50. The transmission assembly 80 is connected to the motor 70 and detachably connected to the piston rod 24 of the adapter mechanism 20. The control unit 60 can determine the operation timing of the motor 70 according to a preset injection mode, and start the motor 70 under control to drive and operate the piston rod 24 via the transmission assembly 80.

[0039] As shown in FIG. 12 and FIG. 15 to FIG. 17, the housing 50 includes a housing main body 51 and a housing cover 52 attached to the housing main body 51. A power supply unit 53 can be attached to the housing 50. The power supply unit 53 may be a battery, a battery pack composed of a plurality of batteries, or the like. Two electrical connectors 54 electrically connected to the control unit 60 are attached inside the housing 50. Two electrode terminals of the power supply unit 53 are connected to the two electrical connectors 54, respectively, and electrically connected to the control unit 60 via the two electrical connectors 54 to supply power to the control unit 60 and the motor 70 of the drive module 3. When the drive module 3 is not in use, an insulating sheet 55 is provided between an end of the power supply unit 53 and one of the electrical connectors 54 corresponding to that position for insulation and separation. The insulating sheet 55 protrudes from the housing 50. When in use, the insulating sheet 55 is pulled out to electrically connect the power supply unit 53 to the electrical connector 54.

[0040] As shown in Figures 15 to 17 and Figures 18 to 19, the transmission assembly 80 includes a driving wheel 81, a connecting rod 82, and a driving element 83. The driving wheel 81 is assembled to the central shaft of the motor 70. One end of the connecting rod 82 is eccentrically connected to the driving wheel 81 so as to be rotatable. The other end of the connecting rod 82 is connected to the driving element 83, and is detachably connected to the tip of the piston rod 24 via the driving element 83. Preferably, the moving direction of the connecting rod 82 and the driving element 83 is parallel to the central axis of the piston rod 24, so that the transmission assembly 80 drives the piston rod 24 to perform a linear and smooth reciprocating motion in the piston barrel 23. Referring to Figures 8, 18 to 19, the connection structure between the driving element 83 and the tip of the piston rod 24 may be an intermediate L-shaped connecting groove formed in the piston rod 24, a central hole of the driving element 83, and a connecting protrusion disposed on the inner side wall of the central hole. Therefore, the piston rod 24 is axially attached to the central hole of the drive element 83, and the connecting protrusion moves linearly along the L-shaped connecting groove and rotates to engage with the tip position of the connecting groove, facilitating assembly of the piston rod 24 and the drive element 83.

[0041] 16 to 17 and 20 to 22, the drive module 3 further includes an activation switch 62. The activation switch 62 is attached to the housing 50 and disposed at the end position of the operation stroke L of the needle output element 121. The activation switch 62 is electrically connected to the control unit 60. When the needle output element 121 is pressed to the end position, the activation switch 62 is activated, and the control unit 60 drives the motor 70 to inject the liquid.

[0042] As shown in Figures 16 to 17 and 20 to 22, the driving module 3 further includes a confirmation switch 63. The confirmation switch 63 is electrically connected to the control unit 60, and is disposed at the end position of the moving stroke S of the contact end cap 113. Alternatively, an abutment seat 56 that is positionally corresponding to the confirmation switch 63 is further provided on the housing body 51. When the contact end cap 113 is certainly pushed into the casing 11, the confirmation switch 63 is operated directly or through the abutment seat to confirm that the contact end cap 113 is attached to the human body and is in a ready-to-inject state (i.e., standby mode). If the contact end cap 113 is not pushed into the inside of the casing 11 so that the confirmation switch 63 is operated, the contact end cap 113 is in an idle state.

[0043] As shown in Figures 16-17 and 18-19, the driving module 3 further includes a counting element 64. The counting element 64 is mounted in the housing 50 and electrically connected to the control unit 60. The counting element 64 is disposed at a predetermined position on the moving path of the driving element 83. When the driving element 83 is moved to the predetermined position, the counting element 64 is activated and outputs an injection signal to the control unit 60. The control unit 60 receives the injection signal, calculates the number of injections, and determines the injection amount.

[0044] As shown in FIG. 11 to FIG. 17, the driving module 3 further includes an indicator light 65. The indicator light 65 is electrically connected to the control unit 60 and can illuminate the housing 50. The indicator light 65 can be controlled to generate signals indicating on, off, and various states. The indicator light 65 includes a first light-emitting element and a second light-emitting element that emit different colors of light. For example, the first light-emitting element is a blue light-emitting element capable of emitting blue light, and the second light-emitting element is a red light-emitting element capable of emitting red light. However, the first light-emitting element and the second light-emitting element that emit different colors of light are not limited to a blue light-emitting element and a red light-emitting element. Under the control of the control unit 60 according to different states, the first light-emitting element (blue light-emitting element) and the second light-emitting element (red light-emitting element) of the indicator light 65 are turned on or off, respectively. Furthermore, the driving module 3 may further include a sound generator 66. The sound generator 66 may be a buzzer, and is electrically connected to the control unit 60, and the sound generator 66 can be controlled to generate sounds to indicate on, off, and various states.

[0045] In the drug injection system, the back surface of the casing 11 of the needle output mechanism 10, the back surface of the outer cover 40 of the drug storage module 2, and the back surface of the housing 50 of the driving module 3 are provided with an adhesive film and a release film disposed on the outer surface of the adhesive film. When using the drug injection system, the release film is first peeled off. After the release film is peeled off, the adhesive film on the back surface of the drug injection system can be adhered to the human body for injection. Preferably, the adhesive film is breathable.

[0046] 11 and 20 to 24, regarding the method of using the drug injection system, the needle output mechanism 10 and the adapter mechanism 20 can be pre-assembled to the injection path module 1 and connected to the drug storage module 2 and the driving module 3. In this way, the contact end cap 113 protrudes from the casing 11 by the elastic force of the elastic element 114, and the breathable adhesive film with the release film is pre-attached to the back of the drug injection system. After being sterilized, the drug injection system can be pre-stored in a sterile container sealed with a sterile film paper.

[0047] When in use, the sterile film paper of the container is torn to take out the drug injection system. The normal appearance of the drug injection system is confirmed by observing whether the contact end cap 113 protrudes outside the casing 11 and checking whether the release film is damaged or contaminated. Before use, confirm that the drug injection system has a normal appearance.

[0048] Meanwhile, the user must first check whether the medicinal liquid filled in the container body 31 of the medicine storage module 2 of the medicine injection system is correct. Confirm that the medicinal liquid is correct before injection. If the container body 31 of the medicine storage module 2 is an empty container that has not been filled with a medicinal liquid in advance, it is necessary to aspirate the correct medicinal liquid with a syringe before injection, pierce the injection end portion 3213 of the container connector 32 with the needle of the syringe, and inject the medicinal liquid in the syringe into the container body 31 via the container connector 32, and then injection is possible.

[0049] 15 to 17, before injection, insulating sheet 55 is peeled off, and power supply unit 53 of drive module 3 is electrically connected to electrical connector 54 to be electrically connected to control unit 60. When switch 61 is switched to the on state, indicator light 65 is lit. Thereafter, the release film on the back of the drug injection system is peeled off, the back of the drug injection system is placed facing the intended injection site of the human body, and contact end cap 113 is brought into contact with the intended injection site of the human body and pressed. When contact end cap 113 is pressed, elastic element 114 is compressed and stored in casing 11, and the breathable adhesive film on the back of the drug injection system is positioned in close contact with the human body. 25 to 27, when the contact end cap 113 is pressed so as to retract to the end position of the movement stroke S in the casing 11, the unlock pressing portion 1131 of the contact end cap 113 presses the engagement hook 1213 of the needle output element 121 in a direction away from the first engagement hole 1111, thereby releasing the needle output element 121 located at the start position of the operation stroke L from the locked state. Meanwhile, the contact end cap 113 presses the abutment seat to activate the confirmation switch 63. The confirmation switch 63 sends a confirmation signal to the control unit 60, and switches the control unit 60 of the pharmaceutical injection system to an injection preparation state (i.e., a standby mode).

[0050] Then, the needle output element 121 is pressed. When the needle output element 121 is pressed to move along the operation stroke L, the toothed drive portion 1212 of the needle output element 121 drives the gear portion 1221 of the rotating element 122 using the forward rotating rack segment 12121 and the reverse rotating rack segment 12122 in succession, so that the rotating element 122 is driven to rotate in the forward rotating direction by the needle output element 121 and then to rotate in the reverse rotating direction. Furthermore, the rotating element 122 drives the needle seat 124 connected to the puncture assembly 13 to move downward and then upward. Due to the downward movement of the needle seat 124, the puncture assembly 13 formed by combining the conduit element 132 and the puncture needle 131 is driven to penetrate downward the seal portion 1234 on the bottom surface of the needle seat plug 123 in the needle output state, and is punctured into the human body. Thereafter, in the needle retracted state, the puncture needle 131 moves upward together with the needle washer 124 to retract the puncture needle 131, and the conduit element 132 is left in place. A part of the conduit element 132 protrudes from the seal portion 1234 and is disposed outside the casing 11. The conduit element 132 remains inserted into the human body. On the other hand, as shown in Figs. 25 to 27 and 22, the engagement hook 1213 of the needle output element 121 that has been moved to the end position of the operation stroke L can engage with the second engagement hole 1112 of the base 111 without pressing the needle output element 121, thereby holding the needle output element 121 in a locked state. On the other hand, when the needle output element 121 is pressed to the end position, the actuation switch 62 is actuated to start the injection state. The control unit 60, which was originally in the injection preparation state (i.e., standby mode), operates the motor 70 upon receiving a signal from the activation switch 62, drives the piston rod 24 of the adapter mechanism 20 to move it at a predetermined speed via the transmission assembly 80, and causes the medicinal liquid in the medicine storage module 2 to flow into the liquid injection chamber 1232 of the needle seat plug 123 via the adapter mechanism 20, and injects the medicinal liquid from the liquid injection chamber 1232 into the human body via the conduit element 132. The counting element 64 can be activated every time the driving element 83 connected to the piston rod 24 performs a pushing injection operation. The control unit 60 determines the timing to stop the motor 70 according to the injection signal received from the counting element 64.The control unit 60 starts timing when it receives an injection signal generated by the active counting element 64. After waiting a predetermined number of seconds, the transmission assembly 80 drives the piston rod 24 of the adapter mechanism 20 to perform the next injection stroke.

[0051] In the above description, as shown in Fig. 11 and Fig. 20 to Fig. 24, when the piston rod 24 is driven to move backward by the drive module 3, the piston chamber 230 in the piston barrel 23 becomes negative pressure, the one-way output valve portion 222 of the flow path switching valve 22 of the adapter mechanism 20 is closed, and the one-way input valve portion 221 is opened. Therefore, the medicinal liquid in the medicine storage module 2 flows into the piston chamber 230 via the container connector 32, the medicinal liquid inflow path 211, and the one-way input valve portion 221 of the adapter mechanism 20. Then, when the piston rod 24 is driven to move forward by the drive module 3, the medicinal liquid in the piston chamber 230 is pushed to become a positive pressure state, the one-way output valve portion 222 of the flow path switching valve 22 of the adapter mechanism 20 is opened, and the one-way input valve portion 221 is closed. Therefore, the medicinal liquid in the piston chamber 230 flows into the liquid injection chamber 1232 of the needle seat plug 123 of the needle output mechanism 10 via the medicinal liquid outflow path 212 and the one-way output valve portion 222 of the adapter mechanism 20, and is injected from the liquid injection chamber 1232 into the human body via the conduit element 132.

[0052] As shown in Figures 11 and 20 to 24, the control unit 60 determines that the target total injection amount of the drug has been reached according to the number of injection signals sent by the counting element 64, and then stops the motor 70 and ends the injection. The user can then remove the drug injection system. In this way, the contact end cap 113 protrudes from the casing 11 due to the elastic force of the elastic element 114 and moves away from the confirmation switch 63, so that the confirmation switch 63 sends a signal to the control unit 60 and is switched to an idle state. Furthermore, the conduit element 132 is disposed on the contact end cap 113 protruding from the casing 11. The contact end cap 113 is sleeved on the conduit element 132, ensuring safety during use.

[0053] In addition, the control unit 60 of the pharmaceutical injection system can also provide warning functions and safety mechanisms using light and sound through a built-in control program in cooperation with a confirmation switch 63, an indicator light 65 including a first light-emitting element (such as a blue light-emitting element) and a second light-emitting element (such as a red light-emitting element) that emit light of different colors, and a sound generator 66, as described in detail below.

[0054] To display or warn of the usage status of the pharmaceutical injection system, the indicator light 65 is under the control of the control unit 60. The indicator light 65 can turn on or off a first light-emitting element (such as a blue light-emitting element) and a second light-emitting element (such as a red light-emitting element) that emit light of different colors according to different states.

[0055] When the insulating sheet 55 is pulled out, the power supply unit 53 supplies power to the control unit 60 of the drive module 3 via the electrical connector 54. When the control unit 60 determines that the power of the power supply unit 53 is greater than a predetermined value or a predetermined ratio, the control unit 60 enters a normal idle state. Then, the first light-emitting element (blue light-emitting element) and the second light-emitting element (red light-emitting element) of the indicator light 65 are controlled to be turned on, and the sound generator 66 is controlled to emit a prompting sound. Thereafter, the second light-emitting element (red light-emitting element) is controlled to be turned off, and the first light-emitting element (blue light-emitting element) maintains the turned-on state. Also, when the control unit 60 determines that the power of the power supply unit 53 is less than a predetermined value or a predetermined ratio, for example, less than 25% of the original stored power, the control unit 60 controls the second light-emitting element (red light-emitting element) of the indicator light 65 to be turned on to enter a flashing cycle, and controls the sound generator 66 to emit a warning sound. Then, the second light-emitting element (red light-emitting element) is controlled to be turned off, and the pharmaceutical injection system is automatically shut down and locked due to a power shortage of the power supply unit 53, and cannot be used for safety reasons.

[0056] When the drug injection system is attached to the human body, the contact end cap 113 presses the abutment seat 56 to activate the confirmation switch 63. The confirmation switch 63 sends a confirmation signal to the control unit 60, which switches the control unit 60 of the drug injection system to an injection preparation state (i.e., standby mode). In the standby mode, if the attachment becomes loose, the contact end cap 113 cannot continue to activate the confirmation switch 63. Then, under the control of the control unit 60, the idle state is resumed. If the drug injection system is reattached to the human body within a specific time (e.g., 10 seconds) for the contact end cap 113 to activate the confirmation switch 63 again, the standby mode can be resumed. If the contact end cap 113 does not return to activate the confirmation switch 63 after the specific time has elapsed, the drug injection system is automatically shut down and locked under the control of the control unit 60.

[0057] When the drug injection system is correctly attached to the human body and the needle output element 121 is pushed to the end position, the activation switch 62 is activated to enter the injection state. In the injection state, if the attachment becomes loose, the contact end cap 113 cannot continue to activate the confirmation switch 63. Then, under the control of the control unit 60, the second light-emitting element (red light-emitting element) of the indicator light 65 is turned on and the sound generator 66 emits a warning sound. Then, if the drug injection system is reattached to the human body within a specific time (for example: 5 seconds) for the contact end cap 113 to activate the confirmation switch 63 again, the injection state can be resumed and the injection of liquid can be continued. If the contact end cap 113 does not return and the confirmation switch 63 does not operate even after the specific time has elapsed, the drug injection system is automatically stopped and locked under the control of the control unit 60, and cannot be used for safety reasons.

[0058] When the liquid injection is normally completed, the pharmaceutical injection system enters an idle state. Under the control of control unit 60, the first light-emitting element (blue light-emitting element) of indicator light 65 remains lit for a certain period of time and then goes out, and the pharmaceutical injection system is locked.

[0059] As described above, by systematically combining the control program built into the control unit 60 with the confirmation switch 63, indicator light 65 and sound generator 66, the drug injection system provides light and sound warning functions and safety mechanisms during use of the drug injection system, ensuring the safety of using the drug injection system of the present invention.

[0060] Although numerous characteristics and advantages of the present invention have been set forth in the foregoing description, together with details of the structure and features of the invention, the disclosure is merely illustrative, and changes may be made in details, particularly in matters of shape, size and arrangement of parts, within the scope of the spirit of the invention to the fullest extent indicated by the broad general meaning of the terms as expressed in the appended claims.

Claims

1. A safety control mechanism for a drug injection system, the drug injection system including: a needle output mechanism, a drug storage module for storing a drug solution, and a control unit; the needle output mechanism including: a casing, a puncture assembly assembled in the casing, and a needle output manipulation assembly assembled in the casing and for manipulating the puncture assembly; a needle output element of the needle output manipulation assembly is movable and lockable within the casing; The safety control mechanism of the drug injection system is characterized in that it comprises a contact end cap mounted within the casing and movable within a travel stroke; a portion of the contact end cap protruding from the casing; and the contact end cap can be forcibly advanced into the casing to release the needle output element from a locked state.

2. 2. The safety control mechanism for a pharmaceutical injection system according to claim 1, A safety control mechanism for a drug injection system, characterized in that the needle output element of the needle output actuation assembly is movable along an actuation stroke within the casing and is lockable at a start position of the actuation stroke.

3. 2. The safety control mechanism for a pharmaceutical injection system according to claim 1, The safety control mechanism of the pharmaceutical injection system further comprises an elastic element arranged between the casing and the contact end cap, and the elastic force of the elastic element acts on the contact end cap to cause the portion of the contact end cap to protrude from the casing.

4. 2. The safety control mechanism for a pharmaceutical injection system according to claim 1, The casing includes a base and an outer casing sleeved around the base, the contact end cap is attached to a rear surface of the outer casing, and a resilient element is disposed between the outer casing and the contact end cap; a contact end cap having an unlocking pressing portion, the contact end cap being forcibly inserted into the outer casing, the unlocking pressing portion pressing the engagement hook of the needle output element to disengage it from the first engagement hole, and releasing the locked needle output element from the locked state.

5. 2. The safety control mechanism for a pharmaceutical injection system according to claim 1, A safety control mechanism for a drug injection system, characterized in that when the needle output element is locked, the needle output element stops the puncture of the puncture assembly.

6. A safety control mechanism for a drug injection system, the drug injection system comprising: a control unit; and a drug storage module for storing a drug solution; The safety control mechanism includes a contact end cap mounted within the casing and movable through a travel stroke; a portion of the contact end cap protruding from the casing; The safety control mechanism of the pharmaceutical injection system comprises a confirmation switch disposed at an end position of the movement stroke of the contact end cap and electrically connected to the control unit; when the contact end cap is pressed so as to be retracted to the end position of the movement stroke, the contact end cap activates the confirmation switch.

7. 7. The safety control mechanism for a pharmaceutical injection system according to claim 6, The drug injection system further comprises a needle output mechanism including the casing; the needle output mechanism further includes a needle output operating assembly assembled within the casing for operating a puncture assembly; the needle output operating assembly includes a needle output element movable within the casing and lockable to stop the puncture assembly from puncturing; the contact end cap can be forcibly advanced into the casing to release the needle output element from a locked state; and when the confirmation switch is activated, the confirmation switch sends a confirmation signal to the control unit, switching the control unit to an injection ready state.

8. 7. The safety control mechanism for a pharmaceutical injection system according to claim 6, The pharmaceutical injection system has a ready-to-inject state and an idle state; and if, in the ready-to-inject state, the contact end cap fails to keep the confirmation switch activated, the control unit switches the pharmaceutical injection system from the ready-to-inject state to the idle state.

9. 9. The safety control mechanism for a pharmaceutical injection system according to claim 8, A safety control mechanism for a pharmaceutical injection system, characterized in that if the contact end cap returns and activates the confirmation switch within a specific time, the injection preparation state is resumed; if the contact end cap does not return and activate the confirmation switch after the specific time has elapsed, the pharmaceutical injection system is automatically stopped and locked under the control of the control unit.

10. 7. The safety control mechanism for a pharmaceutical injection system according to claim 6, The pharmaceutical injection system has an injection state; and if, in the injection state, the contact end cap fails to continue to activate the confirmation switch, the pharmaceutical injection system, under the control of the control unit, issues an alarm. A safety control mechanism for a pharmaceutical injection system.

11. 11. The safety control mechanism for a pharmaceutical injection system according to claim 10, A safety control mechanism for a pharmaceutical injection system, characterized in that if the contact end cap returns and activates the confirmation switch within a specific time, the injection state is resumed and liquid injection is continued; if the contact end cap does not return and activate the confirmation switch after the specific time has elapsed, the pharmaceutical injection system is automatically stopped and locked under the control of the control unit.

12. 7. The safety control mechanism for a pharmaceutical injection system according to claim 6, A safety control mechanism for a pharmaceutical injection system, characterized in that when the contact end cap is pushed to the end position of the movement stroke, the contact end cap activates the confirmation switch via a contact seat.

Images