TWI876810B - Safety control mechanism of drug injection system - Google Patents

Abstract

A safety control mechanism for a drug injection system, the drug injection system includes a needle ejection mechanism, a drug storage module capable of storing drug solution, and a control unit. The needle ejection mechanism is provided with a puncture assembly and a needle ejection operating assembly capable of operating the puncture assembly in a housing, the needle ejection element of the needle ejection operating assembly can move in the housing, and the needle ejection element can be locked; the safety control mechanism includes a contact end cover that can move in a movable stroke in the housing, a part of the contact end cover protrudes out of the housing, and the contact end cover can be forced into the housing to release the locking state of the needle ejection element. Or further comprising an installation switch electrically connected to the control unit, when the contact end cover is pressed and moved to the terminal position, the installation switch can be triggered to send an installation signal to the control unit, so that the control unit switches to the injection preparation state, thereby ensuring the safety of the drug injection system.

Description

Safety control mechanism of drug injection system

This invention is a division of the invention application No. 111139134 "Needle ejection mechanism, injection channel module and drug injection system in drug injection system". This invention is particularly a safety control mechanism of the drug injection system.

The existing drug injection system for subcutaneous injection of liquid medicine in the human body mainly uses a manually or electrically operated injection mechanism connected to a drug container, so that the needle set in the injection mechanism can be inserted into the human body, leaving the soft needle in the needle set to remain inserted into the subcutaneous tissue of the human body, retracting the hard needle, and then manually or electrically driving the liquid medicine to be injected into the subcutaneous tissue of the human body through the soft needle inserted into the body.

The aforementioned injection mechanism can have a soft needle and a hard needle composite needle set to provide components for subcutaneous injection in the human body, but the existing injection mechanism uses a complex needle removal operation mechanism to operate, resulting in the needle set being inserted into the human body in the form of a soft needle sleeve on the outside of the hard needle, and then the hard needle is pulled out, leaving the soft needle in the human body. There is a problem of cumbersome operation.

Furthermore, based on the aforementioned problems of the existing injection mechanism, after the adapter mechanism combined with the injection mechanism is connected to the drug storage mechanism, the delivery path of the drug solution is relatively complicated, and the combination structure between the mechanisms in the drug injection system is also difficult to provide a more ideal injection method. In particular, the drug injection system has the problem of insufficient safety performance, and it is necessary to further optimize the design of the drug injection system.

The purpose of the present invention is to provide a safety control mechanism for a drug injection system to solve the problem of insufficient safety of existing drug injection systems.

In order to achieve the above-mentioned purpose, the present invention proposes a safety control mechanism for a drug injection system, the drug injection system includes a needle ejection mechanism, a drug storage module capable of storing drug solution, and a control unit, wherein the needle ejection mechanism is provided with a puncture assembly and a needle ejection operating assembly capable of operating the puncture assembly in a housing, a needle ejection element of the needle ejection operating assembly can move in the housing, and the needle ejection element can be locked; the safety control mechanism includes: a contact end cover, which is installed in the housing and can move in a movable stroke in the housing, a part of the contact end cover protrudes out of the housing, and the contact end cover can be forced into the housing to release the locking state of the needle ejection element.

In order to achieve the above-mentioned purpose, the present invention further proposes a safety control mechanism for a drug injection system, the drug injection system includes a drug storage module capable of storing drug solution, and a control unit; the safety control mechanism includes: a contact end cover, which is installed in the housing and can move in a movable stroke in the housing, and a part of the contact end cover protrudes out of the housing; a fixing switch, which is located at the end position of the movable stroke of the contact end cover, the fixing switch is electrically connected to the control unit, and the contact end cover can be triggered when it is pressed and moved to the end position.

Through the creation of the safety control mechanism in the aforementioned drug injection system, the safety control mechanism mainly utilizes a contact end cover that can move in a movable stroke in the housing of the needle ejection mechanism of the drug injection system. A portion of the contact end cover protrudes out of the housing, and the contact end cover can be forced into the housing to release the locking state of the needle ejection component, ensuring that the puncture assembly cannot eject the needle before the needle ejection mechanism of the drug injection system is correctly unlocked, providing a good safety control function for the drug injection system.

When the safety control mechanism further includes a confirmation switch located at the end position of the movable stroke of the contact end cover, the confirmation switch is electrically connected to the control unit, and when the contact end cover is pressed and moved to the end position, the confirmation switch can be triggered, so that the confirmation switch sends a confirmation signal to the control unit, and the control unit switches to the injection preparation state. Only then can the drug injection system be operated to perform the injection action, thereby improving the safety of the drug injection system.

1: Injection runner module

2: Drug storage module

3:Drive module

10: Needle ejection mechanism

11: Shell

111: Base

1111: First buckle hole

1112: Second buckle hole

112: Shell

113: Contact end cover

1131: Unlock the push part

S:Activity schedule

114: Elastic element

12: Needle removal operation assembly

121: Needle outlet component

L: Operational stroke

1211: Long rail groove

1212: Driving teeth

12121: Clockwise gear segment

12122: Reverse gear segment

1213: Hook

122: Rotating element

1220: screw hole

1221: Gear unit

123: Needle seat plug

1231: Accommodation room

1232: Injection chamber

1233:Connection interface

1234: Sealing section

1235: Stopper

124: Needle holder

1241: Screw connection part

13:Puncture assembly

131:Puncture needle

132: Pipeline components

1321: Needle end socket

20: Transfer agency

21: Adapter

211: Liquid inlet channel

212: Liquid discharge channel

22: Flow channel switching valve

221: One-way input valve

222: One-way output valve

23: Piston cylinder

230: Piston chamber

231:Connection terminal

2311:Medicine liquid entrance

2312: Liquid medicine outlet

232: tube mouth end

24: Piston rod

30: Liquid medicine storage container

31: Container body

32: Container connector

321: Connector body

3210: Infusion channel

3211:Container connection port

3212: Infusion connection terminal

3213: Infusion end

32131: Infusion branch

3214: Infusion embolism

32141: Embolization end

40: Jacket shell

50: Chassis

51: Chassis body

52: Shell

53: Power supply unit

54:Electrical connectors

55: Insulation film

56: contact piece

60: Control unit

61: Switch

62: Start switch

63: Make sure the switch is installed

64: Counting element

65: indicator light

66: Sound generator

70: Motor

80: Transmission components

81: Driving wheel

82: Connecting rod

83: Driving parts

Figure 1 is a three-dimensional schematic diagram of an embodiment of the needle removal mechanism of the drug injection system of the safety control mechanism of the drug injection system of the present invention.

Figure 2 is a three-dimensional exploded schematic diagram of the needle ejection mechanism embodiment shown in Figure 1.

FIG3 is a schematic top view of the needle ejection element and the rotating element combination in the needle ejection mechanism embodiment shown in FIG2.

FIG4 is a schematic side cross-sectional view of the needle removal mechanism embodiment shown in FIG1 to FIG3.

FIG5 is a schematic side cross-sectional view of another viewing angle of the needle removal mechanism embodiment shown in FIG1 to FIG3.

Figure 6 is a three-dimensional schematic diagram of an embodiment of the injection channel module of the drug injection system of the safety control mechanism of the drug injection system of the present invention.

FIG. 7 is a three-dimensional exploded schematic diagram of the embodiment of the injection channel module shown in FIG. 6 .

FIG8 is a three-dimensional exploded schematic diagram of the adapter mechanism in the embodiment of the injection channel module shown in FIG7.

FIG. 9 is a three-dimensional exploded schematic diagram of another viewing angle of the adapter mechanism in the embodiment of the injection channel module shown in FIG. 7 .

FIG10 is a partial cross-sectional schematic diagram of the embodiment of the injection channel module shown in FIG6.

FIG11 is a three-dimensional schematic diagram of an embodiment of the safety control mechanism of the drug injection system of the present invention.

FIG12 is a three-dimensional exploded schematic diagram of the embodiment of the drug injection system shown in FIG11.

FIG. 13 is a three-dimensional exploded schematic diagram of the drug storage module in the drug injection system embodiment shown in FIG. 11 and FIG. 12.

FIG. 14 is a partial cross-sectional schematic diagram of the drug storage module and the injection channel module shown in FIGS. 11 to 13 after being combined.

FIG. 15 is a partial three-dimensional exploded schematic diagram of the drive module in the embodiment of the drug injection system shown in FIG. 11 and FIG. 12 .

FIG16 is a partial top view of the drive module shown in FIG15 with the housing removed.

FIG17 is a schematic top view of the drug injection system embodiment shown in FIG11 and FIG12 after removing the housing and other components.

FIG. 18 is a three-dimensional schematic diagram of the piston rod of the motor-transmission assembly connecting the adapter mechanism in the drive module shown in FIGS. 15 to 17.

FIG. 19 is a three-dimensional schematic diagram of the piston rod of the motor-transmission assembly connecting the adapter mechanism in the drive module shown in FIGS. 15 to 17.

Figure 20 is a schematic diagram of the operation of the needle ejection mechanism of the drug injection system embodiment (I).

Figure 21 is a schematic diagram of the operation of the needle removal mechanism of the drug injection system embodiment performing the needle removal action (II).

Figure 22 is a schematic diagram of the operation of the needle ejection mechanism of the drug injection system embodiment (III).

Figure 23 is a schematic diagram of the operation of the driving mechanism driving the piston rod to enter the drug liquid delivery embodiment of the drug injection system (I).

Figure 24 is a schematic diagram of the operation of the drug injection system embodiment in which the driving mechanism drives the piston rod to enter the drug liquid delivery (II).

Figure 25 is a schematic diagram of the operation of the embodiment of the drug injection system in which the contact end cover of the needle ejection mechanism is pressed to unlock the needle ejection component (I).

Figure 26 is a schematic diagram of the operation of the embodiment of the drug injection system in which the contact end cover of the needle ejection mechanism is pressed to unlock the needle ejection element (II).

Figure 27 is a schematic diagram of the operation of the needle ejection element of the needle ejection mechanism of the drug injection system embodiment being pressed.

The present invention relates to a safety control mechanism of a drug injection system, which includes an injection channel module 1, a drug storage module 2, and a drive module 3. The injection channel module 1 includes a needle ejection mechanism 10 and a switching mechanism 20. The specific components and structures of the drug injection system are described below with reference to the accompanying drawings.

As shown in Figures 1 to 5, an embodiment of the needle removal mechanism 10 is disclosed. As can be seen from the figures, the needle removal mechanism 10 includes a housing 11, a needle removal operating assembly 12, and a puncture assembly 13.

As shown in Figures 1 to 5, the housing 11 has an assembly space, and the needle removal operating assembly 12 and the puncture assembly 13 are assembled in the assembly space of the housing 11. In this embodiment, the housing 11 includes a base 111 and an outer shell 112 sleeved on the outer side of the base 111. The back side of the outer shell 112 is equipped with a contact end cover 113 that can move in a movable stroke S, and there is an elastic element 114 between the outer shell 112 and the contact end cover 113. The elastic element 114 can be a spring, a spring sheet or other elastic elements. In this embodiment, the elastic element 114 is a compression spring.

As shown in Figures 1 to 5, the needle-exiting operating assembly 12 is installed in the housing 11 and connected to the puncture assembly 13. The needle-exiting operating assembly 12 includes a needle-exiting element 121, a rotating element 122, and a needle seat 124. The needle-exiting element 121 can be movably assembled in the housing 11, the rotating element 122 can be rotatably installed in the housing 11, and the rotating element 122 can be driven by the needle-exiting element 121 to rotate, and the needle seat 124 can be movably assembled in the rotating element 122, and the needle seat 124 can be driven by the rotating element 122 to move between a first position and a second position.

As shown in Figures 1 to 5, the needle-exiting element 121 is assembled in the housing 11 so as to be able to move linearly, and can move in an operation stroke L in the housing 11, and the needle-exiting element 121 can be locked at a starting position and an end position of the operation stroke L, and the rotating element 122 is installed in the base 111 of the housing 11 so as to be driven by the needle-exiting element 121 to rotate forward and reverse. In this embodiment, the needle-exiting element 121 is formed into a button-type component, and the rotating element 122 is formed into a sleeve-type component, but the needle-exiting element 121 and the rotating element 122 are not limited to the aforementioned shapes.

As shown in Figures 1 to 5, the upper end of the rotating element 122 has a gear portion 1221, and the needle-exiting element 121 has a driving gear portion 1212, and the driving gear portion 1212 can be engaged with the gear portion 1221. When the needle-exiting element 121 is pushed, the driving gear portion 1212 and the gear portion 1221 that are engaged with each other drive the rotating element 122 to rotate forward first and then reversely.

As shown in FIGS. 1 to 5 , the needle-exiting element 121 has a long rail groove 1211 extending in a straight line along the operation direction, and the length of the long rail groove 1211 is set as the operation stroke L. The driving gear portion 1212 includes a clockwise gear segment 12121 and a counterclockwise gear segment 12122. The clockwise gear segment 12121 and the counterclockwise gear segment 12122 are respectively located at two sections of the long rail groove 1211 that are different in length direction and are located at two different sides. The clockwise gear segment 1212 1 and the length of the reverse gear segment 12122 are approximately half of the operating stroke L. The gear portion 1221 of the rotating element 122 is located in the long rail slot 1211, and as the needle ejection element 121 moves in the operating stroke L, the gear portion 1221 of the rotating element 122 can engage with one of the forward gear segment 12121 and the reverse gear segment 12122, respectively, so that the rotating element 122 can be driven by the needle ejection element 121 to rotate forward and reverse.

As shown in FIGS. 1 to 5 , the needle removal operation assembly 12 may further include a needle seat plug 123, which is a soft component made of rubber material or the like. The needle seat plug 123 is installed in the base 111 and adjacent to the back of the housing 11. The needle seat plug 123 has a receiving chamber 1231, a liquid injection chamber 1232 located at the lower end of the receiving chamber 1231, and a liquid injection chamber 1232 located at one side of the liquid injection chamber 1232 and connected to the receiving chamber 1231. The connection port 1233 and a sealing portion 1234 located at the lower end of the injection chamber 1232 and exposed on the back of the housing 11, a stopper 1235 is provided between the accommodating chamber 1231 and the injection chamber 1232, and the needle seat 124 is movably assembled in the rotating element 122, and the needle seat 124 can be driven by the rotating element 122 and can move up and down between the rotating element 122 and the needle seat plug 123.

As shown in FIG. 3 and FIG. 25 to FIG. 27, the needle-outlet element 121 is installed in the base 111 and can move within the distance of the operation stroke L. The needle-outlet element 121 can be respectively buckled in the base 111 at the starting position and the end position of the operation stroke L to be locked. The elastic force of the elastic element 114 acts on the contact end cover 113, so that a part of the contact end cover 113 protrudes out of the back side of the outer shell 112. The contact end cover 113 can be forced into the outer shell 112 to release the locking state of the needle-outlet element 121 at the starting position of the operation stroke L.

As shown in Figures 25 to 27, the base 111 has a first buckle hole 1111 at the starting point of the operation stroke L, and a second buckle hole 1112 at the end point of the operation stroke L. The rear end of the needle-exiting element 121 has a buckle hook 1213, and the buckle hook 1213 can be selectively buckled in the first buckle hole 1111 or the second buckle hole 1112. The contact end cover 113 has an unlocking push portion 1131. When the contact end cover 113 is forced into the housing 112, the unlocking push portion 1131 can push the buckle hook 1213 of the needle-exiting element 121 out of the first buckle hole 1111, thereby releasing the locked state of the needle-exiting element 121.

As shown in Figures 1 to 5, the puncture assembly 13 is installed in the housing 11, and the puncture assembly 13 can be operated to produce a needle-out state and a needle-retracted state. The puncture assembly 13 includes a puncture needle 131 and a pipeline component 132. The puncture needle 131 is assembled with the needle seat 124 of the needle-out operating assembly 12, and the pipeline component 132 can be combined with the puncture needle 131. In the needle-out state, the puncture assembly 13 after the pipeline component 132 and the puncture needle 131 are combined is driven by the needle-out operating assembly 12, and the puncture assembly 13 at least partially penetrates the housing 11. In the needle-retracted state, the puncture needle 131 rises along with the needle seat 124 and the puncture needle 131 is retracted.

As shown in FIGS. 4, 5 and 20 to 22, the upper section of the puncture needle 131 of the puncture assembly 13 is assembled with the needle seat 124, and the lower section of the puncture needle 131 extends downward into the needle seat plug 123, the pipeline element 132 is located in the needle seat plug 123 and is sleeved on the outer side of the lower section of the puncture needle 131, and the upper end of the pipeline element 132 has a needle end sleeve portion 1321, and the needle end sleeve portion 1321 sleeves the needle seat 1 24, in the needle-out state, the puncture assembly 13 after the pipeline element 132 and the puncture needle 131 are combined can be operated to first pass downward through the sealing portion 1234 at the bottom of the needle seat plug 123, and in the needle-retracting state, the puncture needle 131 rises with the needle seat 124 and the puncture needle 131 is retracted, and the pipeline element 132 is still retained, and a part of the pipeline element 132 maintains the state of passing through the sealing portion 1234 and being located outside the housing 11.

As shown in Figures 1 to 5, the rotating element 122 and the needle seat 124 are in a screw-connected assembly structure. That is, a screw hole 1220 is provided in the rotating element 122, and the outer peripheral surface of the needle seat 124 has a screw connection portion 1241 and is screwed in 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, the needle-exiting element 121 is further configured to be in the operation stroke L. The needle-exiting element 121 can first drive the rotating element 122 to rotate clockwise and drive the needle seat 124 to push the puncture assembly 13 down to remove the needle, and then the needle-exiting element 121 drives the rotating element 122 to rotate counterclockwise and drive the needle seat 124 and the connected puncture needle 131 to rise and retract the needle, and keep a part of the pipeline element 132 extending out of the housing 11.

The needle ejection mechanism 10 can be applied to a syringe. Referring to FIGS. 3 to 5 and 20 to 27, when the needle ejection mechanism 10 is not used, the puncture assembly 13 of the needle ejection mechanism 10 is hidden in the housing 11. When the needle is ejected, the user directs the back of the needle ejection mechanism 10 toward the injection site of the human body and applies pressure to the housing 11 so that the back of the housing 11 is pressed. The contact end cover 113 is compressed and retracted into the housing 11, and the unlocking push portion 1131 of the contact end cover 113 pushes the hook 1213 of the needle ejection element 121 out of the first buckle hole 1111, thereby releasing the buckled locking state of the needle ejection element 121 at the starting position of the operation stroke L, until the back of the housing 11 is attached to the injection site of the human body.

Next, the needle ejection element 121 is pressed, and the needle ejection element 121 is used to move from the starting position of its operation stroke L to the end position, wherein the needle ejection element 121 drives the rotating element 122 to rotate in the forward direction first and drives the needle seat 124 and the pipeline element 132 connected thereto to push the puncture assembly 13 combined with the puncture needle 131 out of the needle seat plug 123 and pierce into the human body. In the process of the needle ejection element 121 continuing to move to the end position of the operation stroke L, the rotating element 122 is driven to rotate in the reverse direction, and drives the needle seat 124 and the pipeline element 132 connected thereto to push the puncture assembly 13 combined with the puncture needle 131 out of the needle seat plug 123 and pierce into the human body. The needle 131 is retracted into the needle seat plug 123, and the pipeline component 132 is still retained. A part of the pipeline component 132 passes through the needle seat plug 123 and is located outside the housing 11. The pipeline component 132 maintains the position of piercing the human body. At this time, the hook 1213 of the needle-exiting component 121 moved to the end position of the operation stroke L can be buckled in the second buckle hole 1112 of the base 111, so that the needle-exiting component 121 is buckled and locked, so that the user does not need to maintain the action of pressing the needle-exiting component 121, and can inject the liquid medicine. The injection of liquid medicine enters the human body through the pipeline component 132. After the injection of the liquid medicine is completed, the needle removal mechanism 10 is removed from the human body, and the contact end cover 113 is pushed up and reset by the elastic force of the elastic element 114, and is sheathed on the outer side of the pipeline element 132 to provide safety protection.

The conduit element 132 can be a soft needle or a soft tube, such as a heat shrink tube. However, the conduit element 132 is not limited to the above. Any element that is suitable for combining with the puncture needle 131 and puncturing the human body, suitable for being left in the human body and having a conduit through which liquid can flow into the human body can be used as the conduit element 132.

As shown in FIG. 6 and FIG. 7, an embodiment of the injection channel module 1 includes a needle ejection mechanism 10 and a switching mechanism 20. The component structure of the needle ejection mechanism 10 is as described above and will not be described in detail here.

As shown in FIG. 7, FIG. 8 and FIG. 10, the adapter mechanism 20 includes an adapter seat 21, a flow channel switching valve 22, a piston cylinder 23 and a piston rod 24. The adapter seat 21 can be assembled on one side of the housing 11 of the needle ejection mechanism 10. The adapter seat 21 has a liquid medicine input flow channel 211 and a liquid medicine output flow channel 212. The flow channel switching valve 22 is installed on the adapter seat 21. The flow channel 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 cylinder 23 are respectively a connecting end 231 and a barrel end 232. The connecting end 231 is located in the adapter 21 and assembled with the flow channel switching valve 22. The barrel end 232 can extend out of the adapter 21. The piston cylinder 23 has a piston chamber 230. The connecting end The piston chamber 230 is provided with a liquid medicine inlet 2311 and a liquid medicine outlet 2312, the liquid medicine inlet 2311 is connected to the one-way input valve 221, and the liquid medicine outlet 2312 is connected to the one-way output valve 222. The piston rod 24 is arranged in the piston chamber 230 of the piston cylinder 23 and extends out of the adapter 21. The piston rod 24 can be driven in the piston chamber 230 of the piston cylinder 23. 30 inner straight line Movement, wherein when the piston rod 24 moves backward, the liquid medicine can be drawn through the liquid medicine input channel 211 and the one-way input valve 221 and inputted into the piston chamber 230 in one direction, and then when the piston rod 24 moves forward, the liquid medicine in the piston chamber 230 is outputted in one direction to the liquid medicine output channel 212 through the one-way output valve 222, and the liquid medicine for injection is inputted into the needle ejection mechanism 10.

As shown in Figures 7, 8 to 10, the piston rod 24 of the injection channel module 1 can be directly operated manually, or the piston rod 24 is externally connected to a manual drive module 3, or an electric drive module 3 is externally connected to drive the injection channel module 1 to perform the injection of the liquid medicine. In the injection channel module 1, the injection action of introducing the liquid medicine into the needle ejection mechanism 10 by using the adapter mechanism 20 is as described above, and will not be repeated here.

As shown in Figures 11 and 12, the drug injection system includes the injection channel module 1, a drug storage module 2 and a drive module 3. The specific structure of the injection channel module 1 is as described above and will not be described in detail here.

As shown in Figures 12 to 14, the drug storage module 2 includes a liquid medicine storage container 30 and an outer shell 40. The liquid medicine storage container 30 includes a container body 31 and a container connector 32. The container body 31 can be filled with liquid medicine, that is, the container body 31 can be a component pre-filled with liquid medicine, or the container body 31 is a component that is not originally filled with liquid medicine. Before use, the predetermined liquid medicine is injected into the container body 31. The container connector 32 is assembled on the container body 31. The liquid medicine storage container 30 can be connected to the liquid medicine input channel 211 of the adapter mechanism 20 of the injection channel module 1 through the container connector 32. The outer shell 40 can be sleeved on the outside of the liquid medicine storage container 30 and connected to the shell 11 of the needle removal module.

As shown in Figures 12 to 14, the container body 31 can be a bag-shaped component or a bottle-shaped component that can store liquid medicine. In this embodiment, the container body 31 is a bag-shaped component, but it is not limited to this. The container connector 32 is assembled with the container body 31. The container connector 32 has an infusion channel 3210 connected to the container body 31, and is connected to the liquid medicine input channel 211 of the adapter 20 through the infusion channel 3210.

As shown in Figures 12 to 14, the container connector 32 includes a connector body 321, and the connector body 321 includes a container connection end 3211 and an infusion connection end 3212. The infusion flow channel 3210 extends from the container connection end 3211 to the infusion connection end 3212, and the container connection end 3211 is assembled with the container body 31, and the infusion connection end 3212 is assembled with the liquid medicine infusion flow channel 211 of the adapter 20.

As shown in Figures 12 to 14, the connector body 321 may further include an infusion end 3213, the infusion end 3213 includes an infusion branch 32131 connected to the infusion channel 3210, and an infusion plug 3214 is installed in the infusion branch 32131, the infusion plug 3214 closes the infusion branch 32131, and the infusion plug 3214 has an embolism end 32141 exposed on the outside of the connector body 321, and the embolism end 32141 is exposed on the back of the outer shell 40, so that the added liquid medicine can be pierced by the syringe through the embolism end 32141 and pass through the infusion branch 32131 and the infusion channel 3210 to enter the container body 31 of the liquid medicine storage container 30.

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 with the injection channel module 1. The drive module 3 contains an electric energy supply unit 53 or can be connected to an external power source. 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 installed on the housing. Inside the housing 50, the motor 70 is electrically connected and controlled by the control unit 60. The control unit 60 has a switch 61 visible outside the housing 50. The transmission assembly 80 is connected to the motor 70 and is detachably connected to the piston rod 24 of the adapter mechanism 20. The control unit 60 determines the actuation timing of the motor 70 according to the preset injection mode, so that the motor 70 can be controlled to start and drive the piston rod 24 to actuate through the transmission assembly 80.

As shown in FIG. 12 and FIG. 15 to FIG. 17 , the housing 50 includes a housing body 51 and a housing cover 52 mounted on the housing body 51. A power supply unit 53 can be mounted in the housing 50. The power supply unit 53 can be a battery or a battery pack composed of a plurality of batteries. Two electrical connectors 54 electrically connected to the control unit 60 are provided in the housing 50. Two electrode ends of the power supply unit 53 can be respectively connected to the two electrical connectors 54, and the control unit 60 is electrically connected to the two electrical connectors 54, and the power supply unit 53 supplies power to the control unit 60 and the motor 70 of the drive module 3. Before the drive module 3 is used, an insulating sheet 55 is provided between one end of the power supply unit 53 and the corresponding electrical connector 54 for insulation isolation, and the insulating sheet 55 extends out of 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.

As shown in FIGS. 15 to 17 and 18 to 19, the transmission assembly 80 includes a driving wheel 81, a connecting rod 82 and a driven member 83. The driving wheel 81 is assembled with the axle of the motor 70. One end of the connecting rod 82 is eccentrically pivoted on the driving wheel 81, and the other end of the connecting rod 82 is connected to the driven member 83, and is detachably connected to the end of the piston rod 24 through the driven member 83. Preferably, the movement directions of the connecting rod 82 and the driven member 83 are parallel to the central axis of the piston rod 24, so that the transmission assembly 80 drives the piston rod 24 to perform a straight line reciprocating motion in the piston cylinder 23 with good smoothness. As shown in FIG8, FIG18 to FIG19, the assembly structure between the driver 83 and the end of the piston rod 24 can form a middle L-shaped assembly groove using the piston rod 24. The driver 83 has a middle hole and an assembly block located on the inner wall of the middle hole, so that the piston rod 24 is axially assembled in the middle hole of the driver 83, and the assembly block is used to move vertically along the L-shaped assembly block and then rotate and engage with the end of the assembly groove for positioning, thereby improving the assembly convenience between the piston rod 24 and the driver 83.

As shown in Figures 16 to 17 and Figures 20 to 22, the drive module 3 further includes a start switch 62, which is disposed on the housing 50 and is located at the end position of the operation stroke L of the needle ejection element 121. The start switch 62 is electrically connected to the control unit 60, so that when the needle ejection element 121 is pressed and moved to the end position, the start switch 62 is triggered, and then the control unit 60 activates the motor 70 to perform the infusion action.

As shown in Figures 16 to 17 and Figures 20 to 22, the drive module 3 also includes a confirmation switch 63, which is electrically connected to the control unit 60, and the confirmation switch 63 is located at the end position of the active stroke S of the contact end cover 113, or the housing body 51 is further provided with a contact piece 56 corresponding to the confirmation switch 63, so that when the contact end cover 113 is pushed into the housing 11, it can be directly or through the contact piece to trigger the confirmation switch 63, which is used to confirm that it is installed on the human body and enter the injection preparation state (i.e., standby state). If the contact end cover 113 is not pushed into the housing 11 to trigger the confirmation switch 63, it is in an idle state.

As shown in Figures 16 to 17 and Figures 18 to 19, the driving module 3 further includes a counting element 64, which is installed in the housing 50 and electrically connected to the control unit 60. The counting element 64 is located at a predetermined position of the moving path of the driving member 83, so that the counting element 64 can be triggered when the driving member 83 is pushed to the predetermined position, and the counting element 64 outputs an injection signal to the control unit 60. The control unit 60 receives the injection signal and counts the number of injections to determine the injection amount.

As shown in FIGS. 11 to 17 , the drive module 3 further includes an indicator light 65, which is electrically connected to the control unit 60 and can emit light to be exposed outside the housing 50. The indicator light 65 can also be controlled to generate indicator lights such as on, off, and status, wherein the indicator light 65 includes a first light emitting element and a second light emitting element that can emit light of different colors, for example: the first light emitting element is a blue light emitting element that can emit blue light, and the second light emitting element is a red light emitting element that can emit red light, but the first light emitting element and the second light emitting element of different colors are not limited to blue light emitting elements and red light emitting elements. 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 will emit light or turn off respectively. Furthermore, the drive module 3 may also include a sound generator 66, which may be a buzzer, etc., and is electrically connected to the control unit 60, so that the sound generator 66 can be controlled to generate indication sounds such as on, off and status.

The drug injection system can also be provided with a rubber film on the back of the housing 11 of the needle ejection mechanism 10, the back of the outer housing 40 of the drug storage module 2, and the back of the housing 50 of the drive module 3, as well as a release film on the outer surface of the rubber film. When using the drug injection system, the release film is first torn off, and after the release film is torn off, the rubber film on the back of the drug injection system can be attached to the human body to perform the injection. Preferably, the rubber film is a breathable rubber film.

As shown in FIG. 11 and FIG. 20 to FIG. 24, in the use of the drug injection system, the needle ejection mechanism 10 and the adapter mechanism 20 can be pre-assembled into an injection channel module 1, and connected to the drug storage module 2 and the drive module 3. At this time, the contact end cover 113 protrudes out of the housing 11 due to the elastic force of the elastic element 114. In addition, a breathable rubber film with a release film on the surface is pre-attached to the back of the drug injection system. After the aforementioned drug injection system is sterilized, it can be pre-installed in a sterilized container box and sealed with a sterilization film paper.

When using, tear off the sterilization film on the container box and take out the drug injection system. Check whether the contact end cover 113 is protruding outside the shell 11 and whether the release film is damaged or contaminated to confirm whether the appearance of the drug injection system is normal. Use it only after confirming that the appearance of the drug injection system is normal.

On the other hand, the user must first confirm whether the drug solution in the container body 31 in the drug storage module 2 of the drug injection system is correct, and then perform the injection after confirming that the drug solution is correct. If the container body 31 of the drug storage module 2 is an empty container that is not pre-filled with drug solution, before injection, first use a syringe to extract the confirmed drug solution, and use the needle of the syringe to pierce the infusion end 3213 of the container connector 32, so that the drug solution in the syringe is injected into the container body 31 through the container connector 32, and then perform the injection action.

Next, as shown in FIGS. 15 to 17 , before the injection, the insulating sheet 55 is removed, the power supply unit 53 of the drive module 3 is electrically contacted with the electrical connector 54 and electrically connected to the control unit 60, the switch 61 is switched to the on state, and the indicator light 65 is turned on. After that, the release film on the back of the drug injection system is torn off, the back of the drug injection system is facing the injection site of the human body, and the contact end cover 113 is contacted with the injection site of the human body and pressure is applied, the contact end cover 113 is compressed and compresses the elastic element 114 and retracts into the housing 11, and the drug injection system is positioned by adhering to the human body with the air-permeable adhesive film on the back. As shown in FIGS. 25 to 27 , when the contact end cover 113 is compressed and returned to the end position of the active stroke S in the housing 11 , the unlocking push portion 1131 of the contact end cover 113 pushes the hook 1213 of the needle ejection element 121 to disengage from the first buckle hole 1111 , thereby releasing the locked state of the needle ejection element 121 at the starting position of the operation stroke L. At the same time, the contact end cover 113 pushes against the abutment sheet to actuate the installation switch 63 , and the installation switch 63 sends a installation signal to the control unit 60 , so that the control unit 60 of the drug injection system switches to the injection preparation state (i.e., the standby state).

Next, the needle ejection element 121 is pressed. During the operation stroke L when the needle ejection element 121 is pressed, the driving gear portion 1212 of the needle ejection element 121 drives the forward gear segment 12121 and the reverse gear segment 12122 of the gear portion 1221 of the rotating element 122 in turn, so that the rotating element 122 is driven by the needle ejection element 121 to rotate forward first and then reversely, and then the rotating element 122 drives the needle seat 124 connected to the puncture assembly 13 to descend and then rise, wherein the puncture assembly 13 after the conduit element 132 is driven to be combined with the puncture needle 131 when the needle seat 124 descends first penetrates downward through the sealing portion 1234 at the bottom of the needle seat plug 123 to be in a needle ejection state and then pierces into the human body. Afterwards, in the needle retracting state, the puncture needle 131 is raised along with the needle holder 124 to retract the puncture needle 131. At this time, the pipeline element 132 is still retained, and a part of the pipeline element 132 passes through the sealing portion 1234 and is located outside the housing 11. The pipeline element 132 continues to penetrate into the human body.

At this time, as shown in FIGS. 25 to 27 and 22, the hook 1213 of the needle-exiting element 121 moved to the end position of the operation stroke L can be buckled in the second buckle hole 1112 of the base 111, so that the needle-exiting element 121 is buckled and locked, so that the user does not need to maintain the action of pressing the needle-exiting element 121. On the other hand, when the needle-exiting element 121 is pressed to the end position, the start switch 62 is triggered to enter the infusion state. The control unit 60, which is originally in the injection preparation state (i.e., the standby state), receives the signal sent by the start switch 62 and starts the motor 70, and drives the piston rod 24 of the adapter mechanism 20 to move at a predetermined speed through the transmission component 80, thereby extracting the drug liquid in the drug storage module 2 and transferring it to the injection chamber 1232 of the needle seat plug 123 through the adapter mechanism 20, and then injecting it into the human body from the injection chamber 1232 through the pipeline component 132. The driving member 83 connected to the piston rod 24 can trigger the counting element 64 every time it performs the push injection action. The control unit 60 determines the timing of stopping the motor 70 according to the injection signal sent by the counting element 64. When the control unit 60 receives the injection signal generated by the triggering of the counting element 64, the control unit 60 can start timing, wait for a predetermined number of seconds, and then make the transmission assembly 80 drive the piston rod 24 of the adapter mechanism 20 to perform the next injection stroke movement.

As shown in FIG. 11 and FIG. 20 to FIG. 24, in the above, when the piston rod 24 is driven by the driving module 3 to move backward, the piston chamber 230 in the piston cylinder 23 is in a negative pressure state, the one-way output valve portion 222 of the flow channel conversion valve 22 of the adapter mechanism 20 is in a closed state, and the one-way input valve portion 221 is in an open state, so that the drug liquid in the drug storage module 2 passes through the container connector 32, the drug liquid input flow channel 211 of the adapter mechanism 20 and the one-way input valve portion 221 into the piston chamber 230; When the moving module 3 is driven to move forward, the liquid medicine in the piston chamber 230 is pushed by the piston rod 24 and is in a positive pressure state, the one-way output valve part 222 of the flow channel conversion valve 22 of the adapter mechanism 20 is in an open state, and the one-way input valve part 221 is in a closed state, so that the liquid medicine in the piston chamber 230 passes through the liquid medicine output flow channel 212 of the adapter mechanism 20 and the one-way output valve part 222 into the injection chamber 1232 of the needle seat plug 123 of the needle removal mechanism 10, and then is injected into the human body from the injection chamber 1232 through the pipeline element 132.

As shown in Figure 11 and Figures 20 to 24, after the control unit 60 determines that the total target drug infusion volume has been reached according to the number of injection signals sent by the counting element 64, the motor 70 is stopped to end the injection action. The user can then remove the drug injection system, wherein the contact end cap 113 protrudes from the housing 11 by the elastic force of the elastic element 114, and disengages from the installation switch 63, so that the installation switch 63 sends a signal to the control unit 60, and switches to an idle state, and the pipeline element 132 is located inside the contact end cap 113 protruding from the housing 11, and the contact end cap 113 is covered on the pipeline element 132 to ensure safety in use.

In addition, the control unit 60 of the drug injection system can also provide light and sound warning functions and safety mechanisms through its built-in control program, combined with the installation switch 63, the indicator light 65 including the first light emitting element (such as a blue light emitting element) and the second light emitting element (such as a red light emitting element) of different colors, and the sound generator 66, which will be described in detail below.

In order to indicate the use status of the drug injection system and for warning purposes, the indicator light 65 is controlled by the control unit 60. According to different states, the first light-emitting element (such as a blue light-emitting element) and the second light-emitting element (such as a red light-emitting element) that can emit different colors of light will light up or go out respectively.

When the insulating sheet 55 is pulled up, the power supply unit 53 drives the control unit 60 of the module 3 to supply power via the electrical connector 54. If the control unit 60 determines that the power of the power supply unit 53 is greater than a preset value or ratio, it normally enters an idle state, and 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 light up, and the sound generator 66 is controlled to emit a prompt sound, and then the second light-emitting element (red light-emitting element) is controlled to go out, and the first light-emitting element (blue light-emitting element) remains lit. If the control unit 60 determines that the power of the power supply unit 53 is less than a preset value or ratio, for example, the power is less than 25% of the original stored power, the second light-emitting element (red light-emitting element) of the indicator light 65 is controlled to light up and enter a flashing cycle, and the sound generator 66 is controlled to emit a warning sound, and then the second light-emitting element (red light-emitting element) is controlled to go out, and the drug injection system automatically shuts down and locks due to insufficient power in the power supply unit 53, and cannot be used again to maintain safety.

When the drug injection system is attached to the human body, the contact end cap 113 pushes against the contact piece 56 to trigger the installation switch 63, and the installation switch 63 sends a installation signal to the control unit 60, so that the control unit 60 of the drug injection system switches to the injection preparation state (i.e., the standby state). In the standby state, if the attachment state becomes loose, the contact end cap 113 cannot maintain the activation of the installation switch 63, and it will return to the idle state under the control of the control unit 60. If the user re-attaches within a specific time (for example: 10 seconds), the contact end cap 113 returns to the activation of the installation switch 63, and then it can return to the standby state. If the contact end cover 113 still cannot be restored to the triggering confirmation switch 63 after the specified time, the drug injection system will be automatically shut down and locked under the control of the control unit 60.

When the drug injection system is correctly attached to the human body, when the needle-out element 121 is pressed to the end position, the start switch 62 is triggered to enter the infusion state. In the infusion state, if the attachment state is loose, so that the contact end cover 113 cannot maintain the triggering and fixing 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 lit, and the sound generator 66 emits a warning sound. If the user can reattach within a specific time (for example, 5 seconds) and the contact end cover 113 returns to the triggering and fixing switch 63, the infusion state can be restored to continue the infusion. If the contact end cover 113 still cannot be restored to the triggering confirmation switch 63 after the specified time, the drug injection system will be automatically shut down and locked under the control of the control unit 60, and cannot be used again to maintain safety.

When the infusion is completed normally, the drug injection system enters an idle state. Under the control of the control unit 60, the first light-emitting element (blue light-emitting element) of the indicator light 65 continues to light up for a specific time and then goes out, and the drug injection system is locked.

As described above, the drug injection system can provide light and sound warning and safety mechanisms during the use of the drug injection system through the built-in control program in the control unit 60, combined with the systemized combination of the switch 63, the indicator light 65 and the sound generator 66, to ensure the safety of the drug injection system of the present invention.

10: Needle ejection mechanism

11: Shell

113: Contact end cover

S:Activity schedule

114: Elastic element

12: Needle removal operation assembly

121: Needle outlet component

1211: Long rail groove

1212: Driving teeth

12122: Reverse gear segment

122: Rotating element

1220: screw hole

1221: Gear unit

123: Needle seat plug

1231: Accommodation room

1232: Injection chamber

1234: Sealing section

1235: Stopper

124: Needle holder

13:Puncture assembly

Claims (11)

A safety control mechanism for a drug injection system, the drug injection system comprising a needle ejection mechanism, a drug storage module capable of storing drug solution, and a control unit, wherein the needle ejection mechanism is provided with a puncture assembly and a needle ejection operating assembly capable of operating the puncture assembly in a housing, a needle ejection element of the needle ejection operating assembly can move in an operating stroke in the housing and drive the puncture assembly to extend out of the housing to eject the needle, and the needle ejection element can be locked at a starting position and an end position of the operating stroke; the safety control mechanism comprises In summary: a contact end cap is mounted on the housing and can move in a movable stroke in the housing, a part of the contact end cap protrudes out of the housing, when the needle ejection element is locked at the starting position of the operation stroke, the contact end cap can be forced into the housing to release the locking state of the needle ejection element, when the needle ejection element is unlocked and operated to move to the end position along the operation stroke, it can be locked at the end position, and a pipeline element of the puncture assembly extends out of the housing, so that the liquid medicine can be transported through the pipeline element. As described in claim 1, the safety control mechanism of the drug injection system further includes an elastic element installed between the housing and the contact end cover, and the elastic force of the elastic element causes a portion of the contact end cover to protrude outside the housing. The safety control mechanism of the drug injection system as described in claim 1, wherein the housing includes a base and an outer shell mounted on the outer side of the base, the contact end cover is installed on the back side of the outer shell, and an elastic element is provided between the outer shell and the contact end cover; the base has a first buckle hole at the starting position of the operation stroke, and has a first buckle hole at the end position of the operation stroke. There is a second buckle hole, and the rear end of the needle-exiting element has a buckle hook, which can be selectively buckled in the first buckle hole or the second buckle hole. The contact end cover has an unlocking push-pushing part. When the contact end cover is forced into the outer shell, the unlocking push-pushing part can push the buckle hook of the needle-exiting element away from the first buckle hole, thereby releasing the locked state of the needle-exiting element. A safety control mechanism for a drug injection system as described in claim 1, wherein the needle removal element prevents the puncture assembly from being removed when the needle removal element is locked. A safety control mechanism for a drug injection system, the drug injection system includes a drug storage module capable of storing drug solution, and a control unit; the safety control mechanism includes: a contact end cover, which is installed in a housing and can move within a movable stroke in the housing, and a portion of the contact end cover protrudes outside the housing; a fixing switch, which is located at the end position of the movable stroke of the contact end cover, the fixing switch is electrically connected to the control unit, and the contact end cover can be triggered when it is pressed and moved to the end position. The safety control mechanism of the drug injection system as described in claim 5, wherein the drug injection system further comprises a needle ejection mechanism having the housing, wherein the needle ejection mechanism is provided with a needle ejection operating assembly capable of operating a puncture assembly in the housing, wherein the needle ejection operating assembly has a needle ejection element movable in the housing, and the needle ejection element can be locked to prevent the puncture assembly from ejecting the needle; the contact end cover can be forced into the housing to release the locking state of the needle ejection element, and when the confirmation switch is triggered, the confirmation switch will send a confirmation signal to the control unit, so that the control unit switches to the injection preparation state. The safety control mechanism of the drug injection system as described in claim 5, wherein the drug injection system has an injection preparation state and an idle state, and when in the injection preparation state, if the contact end cover cannot maintain the triggering of the installation switch, the control unit switches the injection preparation state to the idle state. The safety control mechanism of the drug injection system as described in claim 5, wherein if the contact end cover is restored to the trigger confirmation switch within a specific time, the drug injection system can be restored to the injection preparation state. If the contact end cover cannot be restored to the trigger confirmation switch after the specific time, the drug injection system is automatically shut down and locked under the control of the control unit. The safety control mechanism of the drug injection system as described in claim 5, wherein the drug injection system has an infusion state, and when in the infusion state, if the contact end cover cannot maintain the triggering of the installation switch, the control unit controls the drug injection system to issue an alarm. The safety control mechanism of the drug injection system as described in claim 9, wherein if the contact end cap is restored to trigger the installation confirmation switch within a specific time, the drug injection system is restored to the infusion state and continues to infuse. If the contact end cap fails to be restored to trigger the installation confirmation switch after the specific time, the drug injection system is automatically shut down and locked under the control of the control unit. The safety control mechanism of the drug injection system as described in claim 5, wherein when the contact end cap is pressed and moved to the end position, the contact end cap triggers the installation switch through an abutment sheet.

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