Needle output mechanism, injection path module and drug injection system

The needle output mechanism and injection path module simplify the operation of drug injection systems by enabling smooth needle protrusion and retraction, ensuring safety and maintaining drug solution integrity through modular design.

JP7765106B2Active Publication Date: 2025-11-06CC BIOTECHNOLOGY CORP
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Patent Information

Application Number
JP2023579383
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Filing Date
2022-10-14
Publication Date
2025-11-06
Estimated Expiration
2042-10-14

AI Technical Summary

Technical Problem

Conventional drug injection systems have complex needle output mechanisms and cumbersome operation methods, with the soft needle being left in the body after the hard needle is withdrawn, and the drug delivery path is complicated.

Method used

A needle output mechanism with a casing containing a needle output manipulation assembly, including a needle output element, rotation element, and needle seat, which allows for the puncture assembly to protrude and retract smoothly, and an injection path module with an adapter mechanism for direct drug solution supply, minimizing contact between the drive module and the solution.

Benefits of technology

Optimizes needle output operation, ensures safety by preventing accidental needle exposure, and maintains drug solution integrity by isolating the drive module from direct contact during injection.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to a needle output mechanism, an infusion pathway module, and a drug injection system. The infusion pathway module includes a needle output mechanism and an adapter mechanism. The drug injection system includes an infusion pathway module, a drug storage module detachably connected to the infusion pathway module, and a drive module. The needle output mechanism includes a casing, and a needle output manipulation assembly and a puncture assembly attached to the casing. The needle seat is driven by a rotating element to complete a needle output movement of the puncture assembly formed by combining the puncture needle and the conduit element, after which the puncture needle is retracted and the conduit element is restrained to protrude from the casing.
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Description

[Technical Field]

[0001] The present invention relates to the technical field of drug injection, and more particularly to a needle output mechanism, an injection path module and a drug injection system. [Background technology]

[0002] Conventional drug injection systems for subcutaneously injecting drug solutions into the human body mainly use a manually or electrically operated injection mechanism, 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 withdrawn while the soft needle of the needle set remains pierced in the skin of the human body, and the drug solution is then injected manually or electrically into the subcutaneous tissue of the human body through the soft needle that has pierced the body.

[0003] The injection mechanism described above has a composite needle set including a soft needle and a hard needle, and provides components for subcutaneous injection into the human body. However, because the conventional injection mechanism is operated by a complex needle output operating mechanism, 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 inside the human body. The operation of the needle set is relatively cumbersome.

[0004] In addition, given the aforementioned problems with conventional injection mechanisms, the delivery path of the drug solution is relatively complicated after connecting the adapter mechanism to the drug storage mechanism. Furthermore, the combined structure of each mechanism in the drug injection system makes it difficult to provide an ideal injection method. Further optimization of the needle output mechanism in the drug injection system is needed. Summary of the Invention

[0005] The technical problem that the present invention aims to solve is to provide a needle output mechanism, an injection path module, and a drug injection system that solves the problem that conventional drug injection systems use complex needle output mechanisms and that the method of operating the puncture assembly is cumbersome, in which a puncture needle with a sleeve-shaped conduit element attached is inserted into the human body, and the conduit element is left in the human body after the puncture needle is withdrawn.

[0006] The technical solution proposed by the present invention is to provide a needle output mechanism, which includes: A casing; a needle output manipulation assembly assembled within the casing and including a needle output element, a rotation element, and a needle seat; a puncture assembly assembled within the casing, the puncture assembly including a puncture needle and a conduit element; the needle output element is movably mounted within the casing; the rotating element is rotatably mounted within the casing and can be driven to rotate by the needle output element; the needle seat is movably mounted within the rotating element and can be driven by the rotating element to move between a first position and a second position; the puncture needle is connected to the needle seat, and the conduit element is connectable to the puncture needle, In the needle output state, the puncture assembly formed by combining the conduit element and the puncture needle is driven by the needle output operating assembly to protrude at least a portion of the puncture assembly from the casing; in the needle retracted state, the puncture needle moves upward together with the needle seat to retract the puncture needle.

[0007] In the needle output mechanism mentioned above, The needle force element is mounted within the casing for linear movement; and the rotation element is mounted within the casing and drivable for forward and reverse rotation by the needle force element.

[0008] In the needle output mechanism mentioned above, The needle output manipulation assembly further includes a needle seat plug, the needle seat plug being mounted within the casing; the puncture needle protruding into the needle seat plug; the conduit element being disposed inside the needle seat plug and sleeve-like around the puncture needle; and the needle seat being drivable by the rotating element to move between the rotating element and the needle seat plug.

[0009] In the needle output mechanism mentioned above, the needle washer plug has a storage chamber, a liquid injection chamber arranged at a lower end of the storage chamber, a connection port arranged at a side of the liquid injection chamber and communicating with the liquid injection chamber, and a seal portion arranged at the lower end of the liquid injection chamber and exposed to a rear surface of the casing, In the needle-out state, the puncture assembly penetrates the seal on the bottom surface of the needle seat plug; in the needle-retracted state, a portion of the conduit element protrudes from the seal.

[0010] In the needle output mechanism mentioned above, the rotating element has a threaded hole formed therein; the needle seat has a threaded portion, which engages with the threaded hole of the rotating element; the rotating element has a gear portion at its upper end; the needle output element has an elongated rail groove and a toothed drive portion disposed within the elongated rail groove, the length of the elongated rail groove being defined as an operating stroke; the toothed drive portion includes a forward rotating rack segment and a reverse rotating rack segment; the forward rotating rack segment and the reverse rotating rack segment are two different parts respectively disposed along the elongated rail groove and disposed on two opposite sides; the gear portion of the rotating element is disposed within the elongated rail groove, As the needle output element moves along the operating stroke, the gear portion of the rotating element can mesh with either the forward rotating rack segment or the reverse rotating rack segment, and the rotating element can be driven to rotate in a forward rotation direction and a reverse rotation direction.

[0011] In the needle output mechanism mentioned above, The casing includes a base and an outer casing sleeve-shaped around the base; a contact end cap movable within a movement stroke is attached to the back surface of the outer casing; an elastic element is disposed between the outer casing and the contact end cap; the needle output element is attached to the base and movable within the distance of the operation stroke; the needle output element can be locked in the base at the start and end positions of the operation stroke, respectively, to enter a locked state; the elastic force of the elastic element acts on the contact end cap, causing a portion of the contact end cap to protrude from the back surface of the outer casing; and the contact end cap can be forcibly inserted into the outer casing to release the needle output element, which is located at the start position of the operation stroke, from the locked state.

[0012] In the needle output mechanism mentioned above, the base has a first engagement hole disposed at the start position of the operating stroke and a second engagement hole disposed at the end position of the operating stroke; an engagement hook is provided at a rear end of the needle output element, and the engagement hook can selectively engage with the first engagement hole or the second engagement hole; the contact end cap has an unlocking pressing portion, When the contact end cap is forcibly inserted into the outer casing, the unlock pressing portion presses the engaging hook of the needle ejection element to disengage it from the first engaging hole, thereby releasing the locked needle ejection element from the locked state.

[0013] The overall structure of the needle output mechanism described above primarily utilizes the combined structure of the needle output element, rotating element, and needle seat of the puncture assembly, allowing the needle output element to drive the rotating element to rotate first forward and then reverse in one operating stroke. Furthermore, the needle seat of the needle seat set is driven by the rotating element, causing the puncture assembly formed by the combination of the conduit element and the puncture needle to output the needle. The puncture needle then moves upward together with the needle seat, retracting the puncture needle, while the conduit element remains protruding from the casing, achieving the needle output state. This facilitates operation of the needle output mechanism when outputting the needle, achieving the objective of product optimization of the present invention.

[0014] The casing of the needle output mechanism of the present invention may further include a base and an outer casing sleeve-shaped around the base. A contact end cap, movable within a stroke, is attached to the rear side of the outer casing. A resilient element is disposed between the outer casing and the contact end cap. The needle output element is attached within the base and movable within the operating stroke. The needle output element can be locked within the base at the start and end positions of the operating stroke, respectively, and enters a locked state. The resilient force of the resilient element acts on the contact end cap, causing a portion of the contact end cap to protrude from the rear side of the outer casing. The contact end cap can be forcibly inserted into the outer casing to release the needle output element, which is located at the start position of the operating stroke, from the locked state. In this way, the needle output mechanism is provided with a safety protection mechanism, so that the needle output element will not accidentally output a needle when the needle output mechanism is not in use. After injection, the contact end cap sleeve-shaped around the lancing assembly can prevent the lancing assembly from being exposed and pricking a person.

[0015] The technical solution proposed by the present invention is to provide an injection path module, which comprises: The needle output mechanism described above; an adapter mechanism attached to a side surface of the needle output mechanism, the adapter mechanism includes an adapter seat, a flow path switching valve, a piston barrel, and a piston rod; The adapter seat is assembled to the needle output mechanism; the flow path switching valve and the piston barrel are both attached to the adapter seat; the adapter seat has a liquid medicine inlet path and a liquid medicine outlet path that communicate with the piston barrel; the flow path switching valve communicates with the connection port of the needle output mechanism via the liquid medicine outlet path of the adapter seat; and the piston rod is assembled to the piston barrel so as to be able to move linearly.

[0016] In the injection pathway module mentioned above, the fluid path switching valve includes a one-way input valve section and a one-way output valve section; the two ends of the piston barrel are a connecting end and a barrel open end, respectively; the connecting end is connected to the fluid path switching valve, and the barrel open end protrudes from the adapter seat; the piston barrel has a piston chamber formed therein; the connecting end has a chemical liquid inlet and a chemical liquid outlet communicating with the piston chamber; the chemical liquid inlet is connected to the one-way input valve section, and the chemical liquid outlet is connected to the one-way output valve section; the piston rod is driven to move linearly within the piston chamber of the piston barrel, and is capable of unidirectionally drawing the chemical liquid into the piston chamber via the chemical liquid inlet path and the one-way input valve section, and unidirectionally outputting the chemical liquid to the chemical liquid outlet path via the one-way output valve section.

[0017] The overall structure of the infusion pathway module described above not only optimizes the needle output movement of the needle output mechanism, but also allows the adapter mechanism to be directly connected to the drug storage module, so that the drug solution can be directly supplied to the needle output mechanism through the adapter mechanism, and the driving module externally connected to the adapter mechanism will not come into contact with the drug solution being injected during the injection process, reducing the possibility of contaminating the drug solution.

[0018] The technical solution proposed by the present invention is to provide a drug infusion system, which comprises: an infusion path module, a drug storage module, and a drive module; the injection path module includes the needle output mechanism and an adapter mechanism, the adapter mechanism being assembled to a side of the needle output mechanism, the adapter mechanism including an adapter seat, a flow path switching valve, a piston barrel, and a piston rod; the adapter seat being assembled to the needle output mechanism; the flow path switching valve and the piston barrel being both attached to the adapter seat; the adapter seat having a liquid medicine inlet path and a liquid medicine outlet path communicating with the piston barrel; the flow path switching valve communicating with the connection port of the needle output mechanism via the liquid medicine outlet path of the adapter seat; the piston rod being assembled to the piston barrel so as to be linearly movable; the drug storage module includes a drug solution storage container and an outer cover; the drug solution storage container includes a container body filled with drug solution and a container connector assembled to the container body; the container connector is connected to the drug solution inflow path of the adapter mechanism of the injection path module; the outer cover is provided in a sleeve shape around the drug solution storage container and can be connected to a casing of the needle output mechanism; The drive module is detachably assembled to the injection path module and is capable of driving the piston rod of the adapter mechanism.

[0019] In the aforementioned drug injection system, The container connector includes a connector body; the connector body includes a container connection end, an injection connection end, and an injection end portion; the injection path of the container connector extends from the container connection end to the injection connection end and is connected to the container body via the container connection end; the injection connection end is connected to the drug solution inlet path of the adapter mechanism; the injection end portion has an injection branch path communicating with the injection path and an injection plug attached to the injection branch path and sealing the injection branch path; the injection plug has a plug end exposed to the outside of the connector body, and the plug end is exposed to the back surface of the outer cover.

[0020] In the aforementioned drug injection system, the casing of the needle force mechanism includes a base and an outer casing sleeve-shaped around the base; a contact end cap movable within a movement stroke is attached to the rear surface of the outer casing; an elastic element is disposed between the outer casing and the contact end cap; the needle force element is attached to the base and movable within a distance of an operation stroke; the needle force element can be locked in the base at the start and end positions of the operation stroke, respectively, to be in a locked state; an elastic force of the elastic element acts on the contact end cap, causing a portion of the contact end cap to protrude from the rear surface of the outer casing; and the contact end cap can be forcibly inserted into the outer casing to release the needle force element, located at the start position of the operation stroke, from the locked state. the flow path switching valve includes a one-way input valve unit and a one-way output valve unit; two ends of the piston barrel are a connection end and a barrel open end, respectively; the connection end is connected to the flow path switching valve, and the barrel open end protrudes from the adapter seat; the piston barrel has a piston chamber formed therein; the connection end has a chemical liquid inlet and a chemical liquid outlet communicating with the piston chamber; the chemical liquid inlet is connected to the one-way input valve unit, and the chemical liquid outlet is connected to the one-way output valve unit; the piston rod is driven to move linearly within the piston chamber of the piston barrel, and is capable of unidirectionally drawing the chemical liquid into the piston chamber via the chemical liquid inlet path and the one-way input valve unit, and unidirectionally outputting the chemical liquid to the chemical liquid outlet path via the one-way output valve unit, The drive module includes a housing, a control unit, a motor having a central axis, and a transmission assembly; the control unit, the motor, and the transmission assembly are all mounted in the housing; the motor is electrically connected to the control unit and controlled by the control unit; the transmission assembly includes a drive wheel, a connecting rod, and a drive element; the drive wheel is assembled to the central axis of the motor, one end of the connecting rod is eccentrically rotatably connected to the drive wheel, and the other end of the connecting rod is connected to the drive element and detachably connected to the tip of the piston rod via the drive element; the movement direction of the connecting rod and the drive element is parallel to the central axis of the piston rod.

[0021] In the aforementioned drug injection system, The housing includes a housing body and a housing cover attached to the housing body; a power supply unit and two electrical connectors can be attached within the housing; the power supply unit can be electrically connected to the control unit via the two electrical connectors; an insulating sheet is provided between an end of the power supply unit and one of the electrical connectors corresponding to that position for insulation and separation; and the insulating sheet protrudes from the housing.

[0022] In the aforementioned drug injection system, the drive module includes an activation switch, a confirmation switch, and a counting element; the activation switch, the confirmation switch, and the counting element are all electrically connected to the control unit; the activation switch is attached to the housing and positioned at the end position of the operating stroke of the needle output element; when the needle output element is pushed to the end position, the activation switch is activated; the confirmation switch is attached to the housing and positioned at an end of the stroke of the contact end cap; and the confirmation switch is activated when the contact end cap is pushed to the end position; The counting element is mounted on the housing and disposed in a path of movement of the drive element; when the drive element is moved, the counting element is actuated.

[0023]

[0006] With the overall structure of the drug injection system described above, in addition to the injection path module having the effect of optimizing the needle output action of the needle output mechanism, the drug solution in the drug container is sent to the piercing assembly for injection by the arrangement of the liquid flow path in the adapter mechanism, the adapter mechanism being detachably connected to the drug solution storage container in the drug storage module, and the piston rod of the adapter mechanism being detachably connected to the drive module and drivable by the drive mechanism. The modular combination structure, the combination structure of the disposable drug injection system, and the adapter mechanism externally connected to the drive module prevents the drive module from coming into contact with the drug solution during the injection process, ensuring safety when using the drug injection system, and the drive assembly can also accurately control the injection driving force and injection amount. [Brief explanation of the drawings]

[0024] [Figure 1] FIG. 1 is a schematic perspective view of one embodiment of the needle output mechanism of the present invention. [Figure 2] FIG. 2 is a schematic exploded perspective view of the embodiment of the needle output mechanism shown in FIG. [Figure 3] FIG. 3 is a schematic top view illustrating 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. [Figure 5] FIG. 5 is a schematic cross-sectional side view of another perspective of the embodiment of the needle output mechanism shown in FIGS. 1-3. [Figure 6] FIG. 6 is a schematic perspective view of one embodiment of an infusion pathway module 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]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. 7. 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 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 the 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 the drive module of the embodiment of the drug injection system shown in FIGS. [Figure 16] FIG. 16 is a schematic plan view of the drive module shown in FIG. 15 with the housing cover removed. [Figure 17] FIG. 17 is a schematic plan 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 that 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 the motor in combination with the transmission assembly of the drive module connecting with the 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 the pharmaceutical injection system of the present invention, showing the needle output mechanism performing a needle output operation. [Figure 21]FIG. 21 is a schematic diagram (2) of an embodiment of the pharmaceutical injection system of the present invention, showing the needle output mechanism performing a needle output operation. [Figure 22] FIG. 22 is a schematic diagram (3) of an embodiment of the pharmaceutical injection system of the present invention, showing the needle output mechanism performing a needle output operation. [Figure 23] FIG. 23 is a schematic diagram (1) of an embodiment of the drug injection system of the present invention showing the drive mechanism that drives the piston rod to deliver the drug solution. [Figure 24] FIG. 24 is a schematic diagram (2) of an embodiment of the drug injection system of the present invention showing the drive mechanism that drives the piston rod to deliver the drug solution. [Figure 25] FIG. 25 is a schematic diagram (1) of an embodiment of a drug injection system of the present invention 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 of the present invention 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 of the present invention showing the needle force element of the needle force mechanism being depressed. [Explanation of symbols]

[0025] 1. Infusion path 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 engaging hook; 122 rotating element; 1220 threaded hole; 1221 gear portion; 123 needle seat plug; 1231 storage chamber; 1232 liquid injection chamber; 1233 connection port; 1234 sealing portion; 1235 stop portion; 124 needle seat; 1241 threaded portion; 13 puncture assembly; 131 Puncture needle; 132 conduit element; 1321 needle end attachment part 20 adapter mechanism; 21 adapter seat; 211 chemical inflow path; 212 chemical outflow path; 22 flow path switching valve; 221 one-way input valve section; 222 one-way output valve section; 23 piston barrel; 230 piston chamber; 231 connection end; 2311 chemical inflow port; 2312 chemical outflow port; 232 barrel open end; 24 piston rod 30 chemical 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 operating 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 INVENTION

[0026] The technical means employed 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.

[0027] According to the description of the invention disclosed above, the present invention comprises a needle output mechanism, an injection path module, and a drug injection system. As shown in Figures 1, 6, and 11, the injection path module 1 includes a needle output mechanism 10 and an adapter mechanism 20. The drug injection system includes the injection path module 1, a drug storage module 2, and a drive module 3. The specific structures of the needle output mechanism 10, the injection path module 1, and the drug injection system of the present invention will be described below with reference to the drawings.

[0028] As shown in FIGS. 1 to 5 , one embodiment of a needle force mechanism 10 of the present invention is disclosed. As can be seen from the drawings, the needle force mechanism 10 includes a casing 11, a needle force manipulation assembly 12, and a puncture assembly 13. As shown in FIGS. 1 to 5 , the casing 11 has an assembly chamber. The needle force 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 that is sleeve-shaped and disposed around the base 111. A contact end cap 113 that is movable within a movement stroke S and a resilient element 114 that is disposed between the outer casing 112 and the contact end cap 113 are attached to the rear side of the outer casing 112. The resilient element may be a coil spring, a leaf spring, or other resilient element. In this embodiment, a compression spring is used as the resilient element 114.

[0029] 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 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.

[0030] 1 to 5, in this embodiment, the needle force element 121 is attached so as to move linearly inside the casing 11. The rotation element 122 is attached to the base 111 of the casing 11 and is driven to rotate forward and backward by the needle force element 121. In this embodiment, the needle force element 121 is formed as a button-type component, and the rotation element 122 is formed as a sleeve-type component. However, the shapes of the needle force element 121 and the rotation element 122 are not limited to this.

[0031] 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 disconnected from the gear portion 1221. When the needle output element 121 is pressed, the rotating element 122 is driven to rotate in the forward rotation direction and then in the reverse rotation direction through transmission between the meshed toothed driving portion 1212 and the gear portion 1221.

[0032] 1 to 5 , in this embodiment, the needle output element 121 has an elongated rail groove 1211, the length of which is defined as the 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 side surfaces. 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 engage 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.

[0033] As shown in FIGS. 1 to 5 , the needle output manipulation 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 a storage chamber 1231, a liquid injection chamber 1232 located at the lower end of the storage chamber 1231, a connection port 1233 located to the side of the liquid injection chamber 1232 and communicating with the liquid injection chamber 1232, and a seal portion 1234 located 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 storage 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 rotated by the rotating element 122 and is movable up and down between the rotating element 122 and the needle seat plug 123.

[0034] As shown in Figures 3 and 25 to 27, the needle drive element 121 is attached to the base 111 and is movable within the distance of the operating stroke L. The needle drive element 121 is locked to the base 111 at the start and end positions of the operating stroke L, respectively, to be in a locked state. The elastic force of the elastic element 114 acts on the contact end cap 113, causing a part of the contact end cap 113 to protrude 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 drive element 121, which is located at the start position of the operating stroke L, from the locked state.

[0035] As shown in FIGS. 25 to 27 , in this embodiment, the base 111 has a first engagement hole 1111 (115) disposed at the start position of the operating stroke L and a second engagement hole 1112 (116) disposed at the end position of the operating stroke L. An engagement hook 1213 is provided at the rear end of the needle force 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 force element 121 to disengage it from the first engagement hole 1111, thereby unlocking the locked needle force element 121.

[0036] As shown in FIGS. 1 to 5 , the puncture assembly 13 is mounted within the casing 11 and is operable between a needle-forward state and a needle-retracted 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-forward 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, causing at least a portion of the puncture assembly 13 to protrude from the casing 11. In the needle-retracted state, the puncture needle 131 moves upward together with the needle seat 124, causing the puncture needle 131 to retract.

[0037] As shown in FIGS. 4, 5, and 20 to 22, in this embodiment, an upper portion of the puncture needle 131 of the puncture assembly 13 is connected to the needle washer 124, and a lower portion of the puncture needle 131 protrudes downward into the needle washer plug 123. The conduit element 132 is disposed inside the needle washer plug 123 and is sleeve-like around the lower portion of the puncture needle 131. A needle end mounting portion 1321 is provided at the upper end of the conduit element 132, and the needle end mounting portion 1321 is sleeve-like on the lower end of the needle washer 124. 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 washer plug 123. In the needle-retracted state, the puncture needle 131 moves upward together with the needle washer 124, retracting the puncture needle 131, while the conduit element 132 remains stationary. A portion of the conduit element 132 is disposed outside the casing 11 , protruding from the seal portion 1234 .

[0038] As shown in FIGS. 1 to 5 , in this embodiment, the rotating element 122 and the needle washer 124 are connected via a screw. That is, the rotating element 122 has a threaded hole 1220 formed therein, and a threaded portion 1241 is provided on the outer circumferential side of the needle washer 124. The threaded portion 1241 engages with the threaded hole 1220 of the rotating element 122, so that forward and reverse rotation of the rotating element 122 can drive the needle washer 124 to move up and down. In this embodiment, to further set the needle output element 121 to the operation stroke L, the needle output element 121 first drives the rotating element 122 to rotate forward to drive the needle washer 124 and press the puncture assembly 13 downward to eject the needle. Next, the needle output element 121 drives the rotating element 122 to rotate backward to drive the needle washer 124 and the puncture needle 131 connected thereto to move upward, thereby retracting the needle and leaving a portion of the conduit element 132 protruding from the casing 11.

[0039] In this embodiment, the needle output mechanism 10 can be used with a syringe. Referring to FIGS. 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 within the casing 11. When outputting a needle, the user positions the back side of the needle output mechanism 10 toward the intended injection site in the human body and applies a pressing force to the casing 11, thereby pushing the contact end cap 113 on the back side of the casing 11 back into the casing 11. The unlock pressing portion 1131 of the contact end cap pushes 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, which is located at the start position of the operating stroke L, from the locked state until the back side of the casing 11 is attached to the intended injection site in the human body.

[0040] When the needle output element 121 is pressed to move it from the start position to the end position of the operating stroke L, the needle output element 121 first rotates the rotating element 122 in the forward direction, pushing the needle washer 124 and the puncture assembly 13, which is connected to the needle washer 124 and is formed by combining the conduit element 132 and the puncture needle 131, out of the needle washer plug 123 and piercing the human body. When the needle output element 121 further moves to the end position of the operating stroke L, the rotating element 122 is further rotated in the reverse 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 portion of the conduit element 132 remains protruding from the needle washer plug 123 and is disposed outside the casing 11. The conduit element 132 remains in the position where it will pierce the human body. Meanwhile, the engagement hook 1213 of the needle output element 121, which has moved to the end position of the operating stroke L, engages 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 and returns to its original position, and is attached around and outside the lower part of the puncture needle 131 to provide safety protection.

[0041] 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 to this. Any element is suitable for use as the conduit element 132 as long as it is suitable for being combined with the puncture needle 131 to puncture the human body, is suitable for being left in the human body, and forms a flow path through which a liquid flows into the human body.

[0042] 6 and 7, one embodiment of the infusion pathway module 1 of the present invention 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.

[0043] As shown in FIGS. 7, 8, and 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 attached to the side of the casing 11. The adapter seat 21 has a liquid chemical inlet channel 211 and a liquid chemical outlet channel 212. The flow path switching valve 22 is attached to the adapter seat 21 and includes a one-way input valve portion 221 and a one-way output valve portion 222. The piston barrel 23 has two ends, a connecting end 231 and a barrel open end 232, respectively. The connecting end 231 is disposed within the adapter seat 21 and connected to the flow path switching valve 22. The barrel open 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 chemical inlet 2311 and a liquid chemical 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 within the piston chamber 230 of the piston barrel 23. When the piston rod 24 moves rearward, the liquid medicine is drawn into the piston chamber 230 in one direction via the liquid medicine inlet channel 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 via the one-way output valve section 222 to the liquid medicine outlet channel 212, and the liquid medicine for injection is input to the injection mechanism 10.

[0044] 7, 8 and 10, the piston rod 24 of the injection pathway module 1 may be operated manually, or the injection pathway 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 pathway 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.

[0045] 11 and 12, one embodiment of the drug injection system of the present invention is disclosed, which includes the injection path module 1, a drug storage module 2, and a driving module 3. The structure of the injection path module 1 has been disclosed above and will not be repeated below.

[0046] As shown in FIGS. 12 to 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 drug solution. That is, the container body 31 is a component that can be filled with drug solution in advance. Alternatively, the container body 31 is a component that is not originally filled with 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 via the container connector 32. The outer cover 40 is provided in a sleeve-like shape around the drug solution storage container 30 and can be connected to the casing 11 of the needle output mechanism.

[0047] 12 to 14, in this embodiment, a bag-shaped member, a bottle-shaped member, or the like for storing a liquid medicine can be used as the container body 31. Note that in this embodiment, a bag-shaped member is used as the container body 31, but this is not limiting. 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 inlet path 211 of the adapter mechanism 20 via the injection path 3210.

[0048] 12 to 14 , the container connector 32 includes a connector body 321. The connector body 321 includes a container connection end portion 3211 and an injection connection end portion 3212. The injection path 3210 extends from the container connection end portion 3211 to the injection connection end portion 3212, and is connected to the container body 31 via the container connection end portion 3211, and is connected to the drug solution inflow path 211 of the adapter mechanism 20 via the injection connection end portion 3212.

[0049] As shown in FIGS. 12 to 14 , in this embodiment, the connector body 321 may further include an injection end portion 3213. The injection end portion 3213 has a branch injection channel 32131 communicating with the injection channel 3210 and an injection plug 3214 attached to the branch injection channel 32131, and the branch injection channel 32131 is sealed by the injection plug 3214. 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 puncturing 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 branch injection channel 32131 and the injection channel 3210.

[0050] As shown in FIGS. 12 and 15 to 17, the drive module 3 is an electric drive module 3. The drive module 3 is detachably assembled to the injection pathway module 1. The drive module 3 includes a power supply unit 53 or is connectable 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 mounted within the housing 50. The motor 70 is electrically connected to and controlled by the control unit 60. The control unit 60 has a switch 61 exposed on the outside of 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 operation timing of the motor 70 according to a preset injection mode, and can controllably start the motor 70 to drive and operate the piston rod 24 via the transmission assembly 80.

[0051] As shown in FIGS. 12 and 15 to 17 , in this embodiment, 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 including multiple batteries, or the like. Two electrical connectors 54 are attached inside the housing 50 and electrically connected to the control unit 60. 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 one end of the power supply unit 53 and one of the electrical connectors 54 corresponding to that end 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.

[0052] As shown in FIGS. 15 to 17 and 18 to 19 , in this embodiment, the transmission assembly 80 includes a drive wheel 81, a connecting rod 82, and a drive element 83. The drive wheel 81 is mounted on the central shaft of the motor 70. One end of the connecting rod 82 is eccentrically rotatably connected to the drive wheel 81. The other end of the connecting rod 82 is connected to the drive element 83, which is detachably connected to the tip of the piston rod 24 via the drive element 83. Preferably, the movement direction of the connecting rod 82 and the drive element 83 is parallel to the central axis of the piston rod 24, thereby allowing the transmission assembly 80 to drive the piston rod 24 to smoothly reciprocate linearly within the piston barrel 23. Referring to FIGS. 8 and 18 to 19 , the connection structure between the drive element 83 and the tip of the piston rod 24 may be an L-shaped connecting groove formed in the middle of the piston rod 24, a central hole in the drive element 83, and a connecting protrusion disposed on the inner sidewall 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.

[0053] 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 is 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 pushed to the end position, the activation switch 62 is activated, and the control unit 60 drives the motor 70 to inject the liquid.

[0054] 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 located at the end of the stroke S of the contact end cap 113. Alternatively, a contact seat 56 that corresponds in position to the confirmation switch 63 is further provided on the housing body 51. When the contact end cap 113 is properly pressed into the casing 11, the confirmation switch 63 is activated directly or via the contact seat to confirm that the device is attached to the body and in a ready-to-inject state (i.e., standby mode). If the contact end cap 113 is not pressed into the casing 11 so that the confirmation switch 63 is activated, the device is in an idle state.

[0055] 16-17 and 18-19, the drive module 3 further includes a counting element 64. The counting element 64 is mounted within the housing 50 and electrically connected to the control unit 60. The counting element 64 is disposed at a predetermined position on the movement path of the drive element 83. When the drive 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.

[0056] As shown in FIGS. 11 to 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 first and second light-emitting elements emitting light of different colors. 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 and second light-emitting elements emitting light of different colors are not limited to blue and red light-emitting elements. 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 respectively turned on and off under the control of the control unit 60 according to different states. 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, which can control the sound generator 66 to generate sounds to indicate on, off, and various states.

[0057] In the drug injection system of the present invention, adhesive films are provided on 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 drive module 3, and release films are disposed on the outer surfaces of the adhesive films. When using the drug injection system, the release films are first peeled off. After the release films are 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 films are breathable.

[0058] 11 and 20 to 24, in a method of using the drug injection system of the present invention, the needle output mechanism 10 and the adapter mechanism 20 can be pre-assembled on the injection path module 1 and connected to the drug storage module 2 and the drive module 3. In this way, the elastic force of the elastic element 114 causes the contact end cap 113 to protrude from the casing 11, and a breathable adhesive film with a release film is pre-attached to the back of the drug injection system. After being sterilized, the drug injection system can be stored in a sterile container sealed with sterile film paper.

[0059] When in use, the sterile film paper of the container is torn to remove the drug injection system. The normal appearance of the drug injection system can be confirmed by observing whether the contact end cap 113 protrudes outside the casing 11 and by checking whether the release film is damaged or contaminated. The normal appearance of the drug injection system can be confirmed before use.

[0060] Meanwhile, the user must first confirm whether the medicinal liquid filled in container body 31 of drug storage module 2 of the drug injection system is correct. Confirming that the medicinal liquid is correct before injection. If container body 31 of drug storage module 2 is an empty container that has not been filled with medicinal liquid beforehand, the user must aspirate the correct medicinal liquid with a syringe before injection, pierce the injection end portion 3213 of container connector 32 with the needle of the syringe, and inject the medicinal liquid in the syringe into container body 31 via container connector 32, after which injection can begin.

[0061] 15 to 17, before injection, insulating sheet 55 is peeled off, and power supply unit 53 of drive module 3 electrically contacts electrical connector 54, thereby electrically connecting to control unit 60. When switch 61 is turned on, indicator light 65 lights up. The release film on the back of the pharmaceutical injection system is then peeled off, the back of the pharmaceutical injection system is placed facing the intended injection site on the human body, and contact end cap 113 is pressed against the intended injection site. When contact end cap 113 is pressed, elastic element 114 is compressed and housed within casing 11, and the breathable adhesive film on the back of the pharmaceutical 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 within the casing 11, the unlock pressing portion 1131 of the contact end cap 113 presses the engagement hook 1213 of the needle ejection element 121 in a direction away from the first engagement hole 1111, thereby releasing the needle ejection element 121, which is 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, switching the control unit 60 of the pharmaceutical injection system to an injection preparation state (i.e., standby mode).

[0062] Then, the needle output element 121 is pressed. When the needle output element 121 is pressed so as to move along the operating 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 rotated in the forward rotation direction and then in the reverse rotation direction by the needle output element 121. Furthermore, the rotating element 122 drives the needle washer 124 connected to the puncture assembly 13 to move downward and then upward. Due to the downward movement of the needle washer 124, the puncture assembly 13 formed by combining the conduit element 132 and the puncture needle 131 is driven so as to penetrate downward through the seal portion 1234 on the bottom surface of the needle washer 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, causing the puncture needle 131 to retract, and the conduit element 132 is left in place. A portion 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. Meanwhile, as shown in FIGS. 25 to 27 and 22, the engaging hook 1213 of the needle force element 121, which has been moved to the end position of the operating stroke L, engages with the second engaging hole 1112 of the base 111 without pressing the needle force element 121, thereby maintaining the needle force element 121 in a locked state. Meanwhile, when the needle force element 121 is pressed to the end position, the activation switch 62 is activated, and the injection state is initiated. The control unit 60, which was originally in an injection preparation state (i.e., standby mode), receives a signal from the activation switch 62 and activates the motor 70, driving the piston rod 24 of the adapter mechanism 20 to move it at a predetermined speed via the transmission assembly 80, causing 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 then injecting 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 drive element 83 connected to the piston rod 24 performs a pushing injection operation. The control unit 60 determines when to stop the motor 70 according to the injection signal received from the counting element 64.The control unit 60 begins timing upon receiving the 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.

[0063] 11 and 20 to 24, when the piston rod 24 is driven to move rearward 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 liquid medicine in the medicine storage module 2 flows into the piston chamber 230 via the container connector 32, the liquid medicine 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 liquid medicine in the piston chamber 230 is pushed to become positive pressure, 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 section 222 of the adapter mechanism 20, and is injected from the liquid injection chamber 1232 into the human body via the conduit element 132.

[0064] 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 based on the number of injection signals sent by the counting element 64, and then stops the motor 70, terminating the injection. The user can then remove the drug injection system. In this manner, the contact end cap 113 protrudes from the casing 11 due to the elastic force of the elastic element 114, moving away from the confirmation switch 63. This causes the confirmation switch 63 to send a signal to the control unit 60, switching it 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 onto the conduit element 132, ensuring safety during use.

[0065] In addition, the control unit 60 of the drug 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.

[0066] Indicator light 65 is under the control of control unit 60 to display the usage status of the pharmaceutical injection system and to provide warnings. Indicator light 65 has 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 can turn them on or off according to different states.

[0067] 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. If the control unit 60 determines that the power of the power supply unit 53 is greater than a predetermined value or a predetermined ratio, it enters a normal idle state. 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 prompting sound. The second light-emitting element (red light-emitting element) is then controlled to light off, 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 predetermined value or a predetermined ratio, for example, less than 25% of the original stored power, it controls the second light-emitting element (red light-emitting element) of the indicator light 65 to light up and enter a flashing cycle, and controls the sound generator 66 to emit a warning sound. The second light-emitting element (red light-emitting element) is then controlled to light off, and the pharmaceutical injection system is automatically shut down and locked due to insufficient power in the power supply unit 53, making it unsafe to use.

[0068] When the drug injection system is attached to the body, the contact end cap 113 presses against the abutment seat 56 to activate the confirmation switch 63. The confirmation switch 63 sends a confirmation signal to the control unit 60, switching the drug injection system's control unit 60 to an injection-ready state (i.e., standby mode). In standby mode, if the attachment becomes loose, the contact end cap 113 will no longer be able to keep the confirmation switch 63 activated. The idle state will then resume under the control of the control unit 60. If the drug injection system is reattached to the body within a specified time (e.g., 10 seconds) for the contact end cap 113 to again activate the confirmation switch 63, the standby mode can be resumed. If the contact end cap 113 does not return to activate the confirmation switch 63 after the specified time has elapsed, the drug injection system will automatically shut down and lock under the control of the control unit 60.

[0069] When the drug injection system is correctly attached to the body and the needle output element 121 is pushed to the end position, the activation switch 62 is activated, entering the injection state. If the attachment becomes loose during the injection state, the contact end cap 113 will no longer be able to keep the confirmation switch 63 activated. Under the control of the control unit 60, the second light-emitting element (red light-emitting element) of the indicator light 65 lights up and the sound generator 66 emits a warning sound. If the drug injection system is then reattached to the body within a specific time (e.g., 5 seconds) for the contact end cap 113 to again activate the confirmation switch 63, the injection state can be resumed and the liquid can be continued. If the contact end cap 113 does not return to its original position and the confirmation switch 63 does not activate after the specific time has elapsed, the drug injection system will automatically stop and lock under the control of the control unit 60, making it unusable for safety reasons.

[0070] When the liquid injection is completed normally, 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.

[0071] 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 of the present invention 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.

[0072] Although numerous features 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 by way of example only, and changes may be made in details, particularly in matters of shape, size and arrangement of parts, within the true spirit of the invention to the fullest extent indicated by the broad general meaning of the terms in which the appended claims are expressed.

Claims

1. A casing; a needle output manipulation assembly assembled within the casing and including a needle output element, a rotation element, and a needle seat; a puncture assembly assembled within the casing, the puncture assembly including a puncture needle and a conduit element; the needle output element is mounted within the casing so as to be linearly movable; the rotating element is mounted within the casing so as to be rotatable, and can be driven by the needle output element to rotate forward and backward; the needle seat is mounted within the rotating element so as to be movably mounted, and can be driven by the rotating element to move between a first position and a second position; the puncture needle is connected to the needle seat, and the conduit element is connectable to the puncture needle, A needle output mechanism characterized in that, in a needle output state, the puncture assembly formed by combining the conduit element and the puncture needle is driven by the needle output operating assembly to cause at least a portion of the puncture assembly to protrude from the casing; and, in a needle retracted state, the puncture needle moves upward together with the needle seat to retract the puncture needle.

2. 2. The needle output mechanism according to claim 1, The needle output mechanism further includes a needle seat plug, the needle seat plug being attached within the casing; the puncture needle protruding into the needle seat plug; the conduit element being disposed inside the needle seat plug and sleeve-like around the puncture needle; and the needle seat being drivable by the rotating element to move between the rotating element and the needle seat plug.

3. 3. The needle output mechanism according to claim 2, the needle washer plug has a storage chamber, a liquid injection chamber arranged at a lower end of the storage chamber, a connection port arranged at a side of the liquid injection chamber and communicating with the liquid injection chamber, and a seal portion arranged at the lower end of the liquid injection chamber and exposed to a rear surface of the casing, A needle force mechanism characterized in that, in the needle force state, the puncture assembly penetrates the seal portion on the bottom surface of the needle seat plug; and, in the needle retracted state, a portion of the conduit element protrudes from the seal portion.

4. 2. The needle output mechanism according to claim 1, the rotating element has a threaded hole formed therein; the needle seat has a threaded portion that engages with the threaded hole of the rotating element; the rotating element has a gear portion at its upper end; the needle output element has an elongated rail groove and a toothed drive portion disposed within the elongated rail groove, the length of the elongated rail groove being defined as an operating stroke; the toothed drive portion includes a forward rotating rack segment and a reverse rotating rack segment; the forward rotating rack segment and the reverse rotating rack segment are two different portions respectively disposed along the elongated rail groove and disposed on two opposite sides; the gear portion of the rotating element is disposed within the elongated rail groove, a gear portion of the rotating element that can be engaged with either the forward rotating rack segment or the reverse rotating rack segment as the needle output element moves along the operating stroke, and the rotating element can be driven to rotate in a forward rotation direction and a reverse rotation direction.

5. The needle output mechanism according to any one of claims 1 to 4, the casing includes a base and an outer casing sleeve-shaped around the base; a contact end cap attached to a rear surface of the outer casing and movable within a movement stroke; an elastic element disposed between the outer casing and the contact end cap; the needle force element attached to the base and movable within a distance of an operating stroke; the needle force element can be locked within the base at a start position and an end position of the operating stroke, respectively, to a locked state; an elastic force of the elastic element acts on the contact end cap, causing a portion of the contact end cap to protrude from the rear surface of the outer casing; and the contact end cap can be forcibly inserted into the outer casing to release the needle force element, located at the start position of the operating stroke, from the locked state.

6. 6. The needle output mechanism according to claim 5, the base has a first engagement hole disposed at the start position of the operating stroke and a second engagement hole disposed at the end position of the operating stroke; an engagement hook is provided at a rear end of the needle output element, and the engagement hook can selectively engage with the first engagement hole or the second engagement hole; the contact end cap has an unlocking pressing portion, when the contact end cap is forcibly inserted into the outer casing, the unlock pressing portion presses the engaging hook of the needle ejection element to disengage it from the first engaging hole, thereby releasing the locked needle ejection element from the locked state.

7. A needle output mechanism; an adapter mechanism attached to a side surface of the needle output mechanism, The needle output mechanism includes: A casing; a needle output manipulation assembly assembled within the casing and including a needle output element, a rotation element, and a needle seat; a puncture assembly assembled within the casing, the puncture assembly including a puncture needle and a conduit element; the needle output element is movably mounted within the casing; the rotating element is rotatably mounted within the casing and can be driven to rotate by the needle output element; the needle seat is movably mounted within the rotating element and can be driven by the rotating element to move between a first position and a second position; the puncture needle is connected to the needle seat, and the conduit element is connectable to the puncture needle, In a needle output state, the puncture assembly formed by combining the conduit element and the puncture needle is driven by the needle output operation assembly to protrude at least a portion of the puncture assembly from the casing; in a needle retracted state, the puncture needle moves upward together with the needle seat to retract the puncture needle; the adapter mechanism includes an adapter seat, a flow path switching valve, a piston barrel, and a piston rod; an adapter seat mounted to the needle output mechanism; the flow path switching valve and the piston barrel are both attached to the adapter seat; the adapter seat has a liquid medicine inlet path and a liquid medicine outlet path communicating with the piston barrel; the flow path switching valve communicates with a connection port of the needle output mechanism via the liquid medicine outlet path of the adapter seat; and the piston rod is mounted to the piston barrel so as to be linearly movable.

8. 8. The infusion pathway module of claim 7, the flow path switching valve includes a one-way input valve unit and a one-way output valve unit; the two ends of the piston barrel are a connection end and a barrel open end, respectively; the connection end is connected to the flow path switching valve, and the barrel open end protrudes from the adapter seat; the piston barrel has a piston chamber formed therein; the connection end has a medicinal liquid inlet and a medicinal liquid outlet communicating with the piston chamber; the medicinal liquid inlet is connected to the one-way input valve unit, and the medicinal liquid outlet is connected to the one-way output valve unit; the piston rod is driven to move linearly within the piston chamber of the piston barrel, and is capable of unidirectionally drawing the medicinal liquid into the piston chamber via the medicinal liquid inlet path and the one-way input valve unit, and unidirectionally outputting the medicinal liquid to the medicinal liquid outlet path via the one-way output valve unit.

9. an infusion path module, a drug storage module, and a drive module; the infusion pathway module includes a needle output mechanism and an adapter mechanism; The needle output mechanism includes: A casing; a needle output manipulation assembly assembled within the casing and including a needle output element, a rotation element, and a needle seat; a puncture assembly assembled within the casing, the puncture assembly including a puncture needle and a conduit element; the needle output element is movably mounted within the casing; the rotating element is rotatably mounted within the casing and can be driven to rotate by the needle output element; the needle seat is movably mounted within the rotating element and can be driven by the rotating element to move between a first position and a second position; the puncture needle is connected to the needle seat, and the conduit element is connectable to the puncture needle, In a needle output state, the puncture assembly formed by combining the conduit element and the puncture needle is driven by the needle output operation assembly to protrude at least a portion of the puncture assembly from the casing; in a needle retracted state, the puncture needle moves upward together with the needle seat to retract the puncture needle; the adapter mechanism is assembled to a side surface of the needle output mechanism, and includes an adapter seat, a flow path switching valve, a piston barrel, and a piston rod; the adapter seat is assembled to the needle output mechanism; the flow path switching valve and the piston barrel are both attached to the adapter seat; the adapter seat has a liquid medicine inlet path and a liquid medicine outlet path that communicate with the piston barrel; the flow path switching valve communicates with a connection port of the needle output mechanism via the liquid medicine outlet path of the adapter seat; the piston rod is assembled to the piston barrel so as to be linearly movable, the drug storage module includes a drug solution storage container and an outer cover; the drug solution storage container includes a container body filled with a drug solution and a container connector assembled to the container body; the container connector is connected to the drug solution inflow path of the adapter mechanism of the injection path module; the outer cover is provided in a sleeve shape around the drug solution storage container and can be connected to the casing of the needle output mechanism; A pharmaceutical injection system, wherein the drive module is detachably attached to the injection path module and is capable of driving the piston rod of the adapter mechanism.

10. 10. The drug injection system of claim 9, The container connector includes a connector body; the connector body includes a container connection end, an injection connection end, and an injection end portion; the injection path of the container connector extends from the container connection end to the injection connection end and is connected to the container body via the container connection end; the injection connection end is connected to the drug solution inlet path of the adapter mechanism; the injection end portion has an injection branch path communicating with the injection path and an injection plug attached to the injection branch path and sealing the injection branch path; the injection plug has a plug end exposed to the outside of the connector body, and the plug end is exposed at the back of the outer cover.

11. 10. The drug injection system of claim 9, the casing of the needle force mechanism includes a base and an outer casing sleeve-shaped around the base; a contact end cap movable within a movement stroke is attached to the rear surface of the outer casing; an elastic element is disposed between the outer casing and the contact end cap; the needle force element is attached to the base and movable within a distance of an operation stroke; the needle force element can be locked in the base at a start position and an end position of the operation stroke, respectively, to be in a locked state; an elastic force of the elastic element acts on the contact end cap, causing a portion of the contact end cap to protrude from the rear surface of the outer casing; and the contact end cap can be forcibly inserted into the outer casing to release the needle force element, located at the start position of the operation stroke, from the locked state. the flow path switching valve includes a one-way input valve unit and a one-way output valve unit; two ends of the piston barrel are a connection end and a barrel open end, respectively; the connection end is connected to the flow path switching valve, and the barrel open end protrudes from the adapter seat; the piston barrel has a piston chamber formed therein; the connection end has a chemical liquid inlet and a chemical liquid outlet communicating with the piston chamber; the chemical liquid inlet is connected to the one-way input valve unit, and the chemical liquid outlet is connected to the one-way output valve unit; the piston rod is driven to move linearly within the piston chamber of the piston barrel, and is capable of unidirectionally drawing the chemical liquid into the piston chamber via the chemical liquid inflow path and the one-way input valve unit, and unidirectionally outputting the chemical liquid to the chemical liquid outflow path via the one-way output valve unit, The drive module includes a housing, a control unit, a motor having a central axis, and a transmission assembly; the control unit, the motor, and the transmission assembly are all attached to the housing; the motor is electrically connected to the control unit and controlled by the control unit; the transmission assembly includes a drive wheel, a connecting rod, and a drive element; the drive wheel is assembled to the central axis of the motor, one end of the connecting rod is eccentrically rotatably connected to the drive wheel, and the other end of the connecting rod is connected to the drive element and detachably connected to the tip of the piston rod via the drive element; a drug injection system characterized in that the movement direction of the connecting rod and the drive element is parallel to the central axis of the piston rod.

12. The drug injection system of claim 11, The housing includes a housing body and a housing cover attached to the housing body; a power supply unit and two electrical connectors can be attached within the housing; the power supply unit can be electrically connected to the control unit via the two electrical connectors; an insulating sheet is provided between an end of the power supply unit and one of the electrical connectors corresponding to that position for insulation and separation; and the insulating sheet protrudes from the housing.

13. The drug injection system of claim 11, the drive module includes an activation switch, a confirmation switch, and a counting element; the activation switch, the confirmation switch, and the counting element are all electrically connected to the control unit; the activation switch is attached to the housing and is disposed at the end position of the operating stroke of the needle output element; when the needle output element is pushed to the end position, the activation switch is activated; the confirmation switch is attached to the housing and positioned at an end position of the stroke of the contact end cap; when the contact end cap is pushed to the end position, the confirmation switch is activated; A drug injection system, characterized in that the metering element is attached to the housing and is disposed in a path of movement of the drive element; and the metering element is actuated when the drive element is moved.

Citation Information

Patent Citations

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  • Injector

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