Continuous micro-dose administration apparatus and injection method

Abstract

A continuous micro-dose administration apparatus, comprising a needle apparatus (5), a drug storage apparatus (4), a piston push rod apparatus (3), a force accumulating apparatus (2), an accumulated force release apparatus (1), and a control apparatus (6). Under the action of the control apparatus (6), the accumulated force release apparatus (1) releases a specified piston stroke, the force accumulating apparatus (2) pushes the piston push rod apparatus (3) to move towards the drug storage apparatus (4) by the specified piston stroke, and a drug liquid in the drug storage apparatus (4) is discharged through the needle apparatus (5). The force accumulating apparatus (2) serves as a power source, a piston body (31) is pushed in a rotating or direct pushing mode, the required number of pulses is calculated according to the required dose of infusion or the piston movement distance, and the control apparatus (6) accurately controls the accumulated force release apparatus (1) to release the specified piston stroke, thereby helping to improve the accuracy of the dose of administration. A rotary magnetic brake assembly (11) is connected to the piston push rod apparatus (3) by means of a coupling assembly (12) formed by a gear set (121) consisting of a plurality of gears, so that a smaller force of the rotary magnetic brake assembly (11) is used to control a larger force of the force accumulating apparatus (2).

Description

Continuous microdosing device and injection method Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a continuous micro-dosing device and an injection method. Background Art

[0002] Continuous drug administration refers to daily administration to maintain effective blood drug concentrations. In the current clinical medical system, continuous drug administration is often used for treatment in medical fields such as endocrinology and analgesia.

[0003] Taking the treatment of diabetes as an example, there are currently two main methods for the treatment and control of diabetes: one is conventional treatment, which involves injecting insulin 1-2 times a day and monitoring blood sugar 1-2 times a day; the other is intensive treatment, which involves multiple blood sugar monitoring sessions a day, simulating the way pancreatic cells secrete insulin, and continuously infusing insulin to keep blood sugar levels as close to normal as possible. This method is often achieved using an insulin pump.

[0004] In 1993, the Diabetes Control and Complications Trial (DCCT) used these two approaches to conduct the largest long-term clinical trial, aiming to investigate the benefits of intensive blood sugar control. The results showed that the average glycated hemoglobin level in the well-controlled group decreased by 2% compared with the poorly controlled group, significantly reducing the risk of chronic complications of diabetes. The risk of diabetic eye disease decreased by approximately 76%, and the risk of kidney and neuropathy was similarly reduced.

[0005] The existing Chinese patent application document with publication number CN113633850B discloses an automatic insulin injection device, including an insulin pen, wherein the needle end of the insulin pen is connected to a protective sleeve for wrapping the needle, and a connecting device is provided between the injection push button of the insulin pen and the protective sleeve for automatically injecting the insulin pen and allowing the needle to enter the patient's skin. This automatic insulin injection device enables the needle to be inserted into the patient's subcutaneous fat to automatically trigger the completion of the insulin dose push injection.

[0006] The conventional automated insulin injection device is difficult to precisely control the dosage of insulin, and has a complex structure and high manufacturing cost, so there is room for improvement. Summary of the Invention

[0007] In view of the defects in the prior art, the object of the present invention is to provide a continuous micro-dosing device and an injection method.

[0008] According to the present invention, a continuous micro-dosing device is provided, comprising a needle device, a drug storage device, a piston push rod device, a force storage device, a force storage release device and a control device; under the action of the control device, the force storage release device releases a specified piston stroke, the force storage device pushes the piston push rod device to move a specified piston stroke into the drug storage device, and the drug liquid in the drug storage device is discharged through the needle device.

[0009] Preferably, the force storage and release device includes a rotary magnetic brake assembly and a coupling assembly, the rotary magnetic brake assembly is electrically connected to the control device, the rotary magnetic brake assembly controls the piston stroke of the piston push rod device through the coupling assembly, and the force storage device outputs rotational torque or linear thrust to the piston push rod device.

[0010] Preferably, the rotating magnetic brake assembly includes a fixed coil and a rotatably arranged permanent magnet, the permanent magnet is radially magnetized, the magnetic field generated by the fixed coil interacts with the radial magnetic field of the permanent magnet to drive the permanent magnet to rotate or position, and an output gear is fixedly arranged on the permanent magnet; the force storage device includes an elastic member, and the elastic member is in a compressed state; the coupling assembly includes a gear set, the output gear is meshed with the transmission starting end gear of the gear set, and a winding wheel is provided on the transmission end gear of the gear set, and a pull wire is wound on the winding wheel, and the pull wire extends through one end of the elastic member away from the piston push rod device along the telescopic direction of the elastic member to the piston push rod device and is connected to the piston push rod device.

[0011] Preferably, the rotating magnetic brake assembly includes a fixed coil and a rotatable permanent magnet, the permanent magnet is radially magnetized, the magnetic field generated by the fixed coil interacts with the radial magnetic field of the permanent magnet to drive the permanent magnet to rotate or position, and an output gear is fixedly provided on the permanent magnet; the force storage device includes a first torsion spring, and the first torsion spring is in a compressed state; the coupling assembly includes a gear set, the output gear is meshed with the transmission starting end gear of the gear set, and a worm is provided on the transmission end gear of the gear set; the piston push rod device includes a piston, a screw rod, a sleeve assembly and a worm wheel, the piston is arranged in the medicine storage device, one end of the screw rod is fixedly connected to the piston body, the other end of the screw rod extends into the sleeve assembly and is threadedly connected to the inner wall of the sleeve assembly, the worm wheel is fixedly connected to the outer wall of the sleeve assembly, and the worm wheel is meshed with the worm; one end of the first torsion spring is fixedly connected to the sleeve assembly, and the other end of the first torsion spring is fixedly connected to the injection device housing.

[0012] Preferably, the sleeve assembly includes a screw sleeve, a worm gear sleeve and a locking assembly, the screw sleeve extends into the worm gear sleeve, and the outer wall of the screw sleeve and the inner wall of the worm gear sleeve slide together along the axial direction of the sleeve assembly; the locking assembly fixedly connects the screw sleeve and the worm gear sleeve, the screw extends into the screw sleeve, and the worm gear is arranged on the outer wall of the worm gear sleeve.

[0013] Preferably, the locking assembly includes a locking steel ball and a locking slot, the locking slot is relatively fixedly connected to the worm gear sleeve, and the screw sleeve passes through the locking slot and extends into the worm gear sleeve; the locking steel ball is arranged on the outer surface of the screw sleeve, and the locking slot is provided with a receiving groove with a gradually decreasing diameter on the side close to the locking steel ball, and the locking steel ball is embedded in the receiving groove.

[0014] Preferably, a safety valve is provided on the connecting pipeline between the drug storage device and the needle device, and the safety valve includes a valve body, a diaphragm and a sealing ring. The valve body is provided with a liquid outlet, and the liquid outlet is connected to the needle device; the sealing ring and the diaphragm are arranged on the valve body in sequence, the liquid outlet is located in the middle of the sealing ring, and the side of the diaphragm away from the sealing ring is connected to the drug storage device; the diaphragm is provided with a liquid inlet, the sealing ring is provided with a limiting flow hole, and the valve body is provided with a guide groove, and the liquid inlet, the limiting flow hole and the guide groove are connected in sequence; when the safety valve is in an open state, a liquid outlet cavity is formed between the diaphragm and the liquid outlet, and the guide groove is connected to the liquid outlet cavity; when the safety valve is in a closed state, the diaphragm is in contact with the liquid outlet.

[0015] Preferably, the needle device includes a vertical needle seat, a rotating needle seat, a hard needle seat, a soft needle seat, a hard needle and a soft needle, and the rotating needle seat is rotatably raised and lowered in the vertical needle seat; a rotating needle seat guide groove is provided on the outer wall of the rotating needle seat, and the rotating needle seat guide groove spirally extends downward from the upper end of the rotating needle seat to the lower end of the rotating needle seat, and then spirally extends upward from the lower end of the rotating needle seat to the upper end of the rotating needle seat; a vertical needle seat guide groove is vertically provided on the inner wall of the vertical needle seat, and the soft needle seat and the hard needle seat are both slidably arranged in the vertical needle seat guide groove from bottom to top in sequence, a soft needle is connected to the bottom of the soft needle seat, and a hard needle is connected to the bottom of the hard needle seat, the hard needle passes through the soft needle seat and the soft needle in sequence from top to bottom, and the hard needle seat is slidably arranged in the rotating needle seat guide groove.

[0016] According to the present invention, an injection method of a continuous micro-dosing device is provided, and the injection method comprises the following steps:

[0017] Step S1, adding a sufficient amount of liquid medicine into the medicine storage device;

[0018] Step S2: the control device obtains an injection instruction or injection program input from the outside;

[0019] Step S3: The control device starts to control the force storage release device to release the specified piston stroke, and the force storage device pushes the piston push rod device to move the specified piston stroke into the medicine storage device to complete the quantitative injection.

[0020] Preferably, step S3 includes the following sub-steps:

[0021] Step S3.1: The control device converts the externally input injection instruction or injection program into a series of corresponding electric pulse signals and transmits them to the fixed coil;

[0022] Step S3.2: The fixed coil drives the permanent magnet to move accordingly, causing the output gear to rotate, and the worm gear to rotate through the gear set, causing the screw sleeve to move into the worm gear sleeve until the locking steel ball is embedded in the receiving groove of the locking slot, thereby locking the screw sleeve and the worm gear sleeve;

[0023] Step S3.3: The control device obtains the locking signals of the screw sleeve and the worm gear sleeve, and releases the piston stroke contained in the externally input injection instruction through the coil, the output gear and the gear set to complete the quantitative injection.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] 1. The present invention uses a force storage device as a power source to push the piston by rotation or direct push. The required number of pulses is calculated according to the required infusion dose or the distance the piston moves. The control device accurately controls the force storage release device to release the specified piston stroke, which helps to improve the accuracy of the drug administration dose.

[0026] 2. The present invention connects the rotating magnetic brake assembly and the piston push rod device through a coupling assembly composed of a gear set composed of multiple gears, thereby achieving the goal of using the smaller force of the rotating magnetic brake assembly to control the larger force of the power storage device.

[0027] 3. The present invention uses a sleeve assembly to enable the screw and the screw sleeve to move into the worm sleeve when the medicine liquid is injected into the medicine storage cavity. During injection, the worm gear rotates to lock the screw sleeve and the worm sleeve with the help of the locking assembly, thereby solving the problem that the worm gear sleeve and the screw sleeve need to slide freely during filling and lock each other during injection.

[0028] 4. The present invention uses a safety valve. When the coupling fails, the surface pressure of the diaphragm close to the medicine storage device suddenly increases under the restriction of the flow limiting hole, causing the diaphragm to deform toward the liquid outlet. The arc-shaped sealing surface of the sealing boss structure of the diaphragm covers the liquid outlet, sealing the liquid outlet and preventing the medicine from flowing out, thereby solving the safety problem when the equipment fails. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Other features, objects and advantages of the present invention will become more apparent upon reading the detailed description of non-limiting embodiments with reference to the following drawings:

[0030] FIG1 is a schematic diagram of the overall structure of the injection device mainly embodied in the present invention;

[0031] FIG2 is an exploded schematic diagram of the overall structure of a rotary magnetic brake assembly according to the present invention;

[0032] FIG3 is a schematic diagram of the overall structure of a rotary magnetic brake assembly according to the present invention;

[0033] FIG4 is a schematic diagram of the structure of the coupling assembly and the power storage device in the first embodiment of the present invention;

[0034] FIG5 is an exploded schematic diagram of the overall structure of the needle device according to the present invention;

[0035] FIG6 is a schematic diagram of the needle seat structure of the needle device according to the present invention;

[0036] FIG7 is an exploded view of the overall structure of the safety valve according to the present invention;

[0037] FIG8 is a cross-sectional view showing the overall structure of the safety valve according to the present invention;

[0038] FIG9 is an exploded schematic diagram of the overall structure of the injection device in the second embodiment of the present invention;

[0039] FIG10 is an exploded schematic diagram of the overall structure of the locking assembly according to the present invention;

[0040] FIG11 is a cross-sectional view showing the overall structure of the piston push rod device of the present invention.

[0041] As shown in the figure: Accumulated force release device 1, screw 32, rotating needle seat guide groove 57, rotating magnetic brake assembly 11, worm gear 33, vertical needle seat guide groove 58, fixed coil 111, sleeve assembly 34, second torsion spring 59, permanent magnet 112, screw sleeve 341, needle button 510, output gear 113, worm gear sleeve 342, control device 6, magnetic conductive sheet 114, locking assembly 35, circuit board 61, limiting hole 115, locking steel ball 351, safety valve 7, coupling assembly 12, locking slot 352, valve body 71, gear set 121, receiving groove 353, diaphragm 72, transmission starting end gear 122, locking trigger reed 354, liquid inlet hole 721, transmission end gear 123, guide rod 36, sealing ring 73, winding wheel 124, medicine storage device 4, flow limiting hole 731, pull wire 125, medicine storage cavity 41, liquid outlet 74 Worm 126, needle assembly 5, guide groove 75, guide post 127, vertical needle seat 51, annular receiving groove 76, force storage device 2, rotating needle seat 52, sealing boss structure 77, compression spring 21, hard needle seat 53, housing 8, first torsion spring 22, soft needle seat 54, sleeve lock signal switch 81, piston push rod assembly 3, hard needle 55, guide seat 82, piston body 31, soft needle 56 DETAILED DESCRIPTION

[0042] The present invention will be described in detail below with reference to specific embodiments. The following examples will help those skilled in the art to further understand the present invention, but are not intended to limit the present invention in any form. It should be noted that, for those skilled in the art, several changes and improvements can be made without departing from the scope of the present invention. These all fall within the scope of protection of the present invention.

[0043] Example 1

[0044] As shown in FIG1 , a continuous micro-dosing device according to the present invention comprises a needle device 5, a drug storage device 4, a piston push rod device 3, a force storage device 2, a force release device 1, and a control device 6. Under the action of the control device 6, the force release device 1 releases a specified piston stroke, the force storage device 2 pushes the piston push rod device 3 into the drug storage device 4 to move a specified piston stroke, and the drug liquid in the drug storage device 4 is discharged through the needle device 5.

[0045] The designated piston stroke in this application is an infusion instruction issued by the staff to the control device 6 via information transmission methods such as Bluetooth communication. After receiving the infusion instruction, the control device 6 sends a corresponding electric pulse to the force release device 1 to release the designated piston stroke. This enables the force storage device 2 to push the piston push rod device 3 into the drug storage device 4 to move the designated piston stroke, thereby squeezing the liquid medicine in the drug storage device 4 and expelling the squeezed liquid medicine through the pipeline and then through the needle of the needle device 5.

[0046] Specifically, the injection device also includes a housing 8, which serves as a mounting base for its components and possesses a certain degree of structural strength. The force storage and release device 1 includes a rotating magnetic brake assembly 11 and a coupling assembly 12. The rotating magnetic brake assembly 11 is electrically connected to the control device 6 and controls the piston stroke of the piston push rod assembly 3 via the coupling assembly 12. The force storage device 2 outputs linear thrust to the piston push rod assembly 3.

[0047] As shown in Figures 1, 2, and 3, more specifically, the rotary magnetic brake assembly 11 includes a fixed coil 111 and a rotatably mounted permanent magnet 112. The permanent magnet 112 is radially magnetized. The magnetic field generated by the fixed coil 111 interacts with the radial magnetic field of the permanent magnet 112 to drive the permanent magnet 112 to rotate or position. An output gear 113 is fixedly mounted on the permanent magnet 112. The fixed coil 111 includes a coil and a fixed bracket. The coil is wound on the fixed bracket, which is fixedly mounted on the housing 8 via fasteners. A magnetic conductive sheet 114 is also fixedly mounted on the housing 8 via fasteners. The magnetic conductive sheet 114 is provided with a limiting hole 115 that allows the permanent magnet 112 to rotate and position. The permanent magnet 112 is cylindrical in shape. The cylindrical permanent magnet 112 is placed in the limiting hole 115 and is rotatably mounted on the housing 8 via a coaxial rotating shaft. Magnetic sheet 114 is capable of generating an alternating magnetic field. The magnetic field generated by fixed coil 111 interacts with the magnetic field of permanent magnet 112, causing permanent magnet 112 to rotate by a certain angle, particularly 180 degrees. Output gear 113 is coaxially secured to permanent magnet 112, and rotation of permanent magnet 112 drives output gear 113 to rotate.

[0048] It should be noted that the rotary magnetic brake assembly 11 of the present application can also be a magnetoelectric brake, an electromagnetic swing fork or an electromagnetic ring that can output torque in the prior art.

[0049] The control device 6 includes a circuit board 61, on which a communication module, a data processing module, a data storage module and a signal conversion module are integrated. The signal conversion module and the communication module are electrically connected, and the circuit board 61 is electrically connected to the fixed coil 111. The communication module of the control device 6 can receive external wired or wireless infusion command signals or infusion programs. According to the received infusion information, the data processing module can automatically control the signal conversion module to generate corresponding electric pulse signals as required. The electric pulse signals are transmitted to the fixed coil 111 to control the permanent magnet 112 to rotate a certain angle, thereby controlling the output gear 113 to rotate a certain angle.

[0050] As shown in Figures 1, 2, 3, and 4, the coupling assembly 12 includes a gear set 121, which includes a plurality of meshing gear structures. Each gear of the gear set 121 is rotationally connected to the housing 8 via a rotating shaft. The gear set 121 includes at least one transmission starting end gear 122 and at least one transmission ending gear 123. The output gear 113 meshes with the transmission starting end gear 122 of the gear set 121. At least one intermediate transmission gear is disposed between the transmission starting end gear 122 and the transmission ending gear 123. The intermediate transmission gear meshes with the transmission starting end gear 122 and another intermediate transmission gear, or meshes with the transmission ending gear 123 and another intermediate transmission gear, or meshes with two other intermediate transmission gears.

[0051] The force storage device 2 includes an elastic part, which is in a compressed state. The elastic part of the present application outputs a linear thrust and can be an elastic device such as a compression spring 21, a rubber band, a compressed air spring, etc. in the prior art that can store potential energy. The elastic part of the embodiment of the present application is preferably a compression spring 21.

[0052] A winding wheel 124 is coaxially mounted on the transmission terminal gear 123 of the gear set 121. A pull wire 125 is wound around the pull wire 125. The pull wire 125 extends from the end of the compression spring 21 away from the piston push rod assembly 3 along the expansion and contraction direction of the compression spring 21 to the piston push rod assembly 3 and is connected to the piston push rod assembly 3. The gear set 121 can convert the rotation angle of the output gear 113 into the linear motion stroke of the pull wire 125 at a certain ratio. When a medical solution needs to be injected, the user sends a specific infusion instruction to the control device 6. After receiving the specific infusion instruction, the control device 6 sends a corresponding electric pulse signal to the fixed coil 111, causing the permanent magnet 112 and the output gear 113 to rotate a certain angle. The output gear 113 then releases a certain length of the pull wire 125 through the gear set 121, thereby releasing the specified piston stroke. In this case, the specified piston stroke is the same as the length of the released pull wire 125.

[0053] Furthermore, the gear set 121 and the compression spring 21 are arranged side by side, and a guide column 127 is provided on the housing 8. The guide column 127 is arranged on the side of the compression spring 21 away from the piston push rod device 3. The pull wire 125 on the take-up wheel first bypasses the guide column 127 and then extends through the end of the compression spring 21 away from the piston push rod device 3 along the telescopic direction of the compression spring 21 to the piston push rod device 3 and is connected to the piston push rod device 3.

[0054] The piston push rod device 3 includes a piston body 31, and the drug storage device 4 includes a drug storage cavity 41. The piston body 31 extends into the drug storage cavity 41 and is slidably connected to the inner wall of the drug storage cavity 41. A dynamic seal is provided between the piston body 31 and the inner wall of the drug storage cavity 41 to prevent the drug liquid from leaking out from the connection between the piston body 31 and the inner wall of the drug storage cavity 41. The movement direction of the piston body 31 in the drug storage cavity 41 is parallel to the expansion and contraction direction of the compression spring 21, and the compression spring 21 is connected or crimped to the piston body 31. Since the compression spring 21 is in a compressed state, it stores sufficient elastic potential energy. When the gear set 121 releases a certain length of the pull wire 125, under the action of the compression spring 21, the piston body 31 can move a certain length into the drug storage cavity 41. It should be noted that the cross-sectional area of ​​the medicine storage cavity 41 can be determined during processing. When the piston body 31 moves a certain length into the medicine storage cavity 41, the volume of the medicine liquid discharged when the piston body 31 moves a certain length in the medicine storage cavity 41 can be calculated, thereby realizing quantitative infusion of the medicine liquid, which helps to improve the accuracy of the medicine liquid infusion.

[0055] With the help of gear set 121, the tiny force of the rotating magnetic brake assembly 11 can be used to control the larger force of the force storage device 2. While meeting the same clinical needs, the technical solution of this application greatly reduces the cost compared to servo motors and memory alloys, and the required power and energy consumption is only one-tenth or even one-hundredth, which can greatly reduce the cost of medical equipment for patients and reduce battery consumption and pollution.

[0056] As shown in Figures 5 and 6, the needle device 5 includes a vertical needle seat 51, a rotating needle seat 52, a hard needle seat 53, a soft needle seat 54, a hard needle 55, a soft needle 56, a second torsion spring 59 and a needle-piercing button 510. The vertical needle seat 51 is fixedly mounted on the housing 8. The rotating needle seat 52, the second torsion spring 59 and the needle-piercing button 510 are coaxially arranged in the vertical needle seat 51 from bottom to top. The rotating needle seat 52 is rotatably raised and lowered in the vertical needle seat 51, and the rotating needle seat 52 rotates and cooperates with the inner wall of the vertical needle seat 51. A rotating needle seat guide groove 57 is provided on the outer wall of the rotating needle seat 52. The rotating needle seat guide groove 57 spirally extends downward from the upper end of the rotating needle seat 52 to the lower end of the rotating needle seat 52, and then spirally extends upward from the lower end of the rotating needle seat 52 to the upper end of the rotating needle seat 52. The lower end of the second torsion spring 59 is connected or crimped to the upper end of the rotating needle seat 52, and the upper end of the second torsion spring 59 is connected to the needle insertion button 510. When the torsion spring is subjected to vertical pressure, it can drive the rotating needle seat 52 to rotate downward in the vertical direction.

[0057] A vertical needle seat guide groove 58 is vertically provided on the inner wall of the vertical needle seat 51. The soft needle seat 54 and the hard needle seat 53 are sequentially arranged in the vertical needle seat guide groove 58 from bottom to top, and both the soft needle seat 54 and the hard needle seat 53 slide and cooperate with the vertical needle seat guide groove 58. A soft needle 56 is connected to the bottom of the soft needle seat 54, and a hard needle 55 is connected to the bottom of the hard needle seat 53. The hard needle 55 passes through the soft needle seat 54 and the soft needle 56 in sequence from top to bottom, and the hard needle seat 53 is simultaneously slidably arranged in the rotating needle seat guide groove 57. It should be noted that the soft needle 56 is coaxially sleeved on the outside of the hard needle 55, and the hard needle 55 provides support for the soft needle 56 when piercing the skin.

[0058] Press the needle insertion button 510, the second torsion spring 59 pushes the rotating needle seat 52 to rotate downward, and the hard needle seat 53 cannot move left and right under the restriction of the vertical needle seat guide groove 58, and can only slide in the rotating needle seat guide groove 57 and be pushed by the rotating needle seat guide groove 57 to move up and down in the vertical needle seat guide groove 58. When the rotating needle seat guide groove 57 rotates the first half circle, it pushes the hard needle seat 53, hard needle 55, soft needle seat 54 and soft needle 56 to move downward together to insert the hard needle 55 and soft needle 56 into the subcutaneous tissue. When the rotating needle seat guide groove 57 rotates the second half circle, it pushes the hard needle seat 53 to move upward and pull out the hard needle 55, leaving the soft needle 56 under the skin.

[0059] The soft needle 56 is connected to the drug storage cavity 41 through a pipeline. A safety valve 7 is provided on the communication pipeline between the drug storage device 4 and the needle device 5. The safety valve 7 is used to connect or block the fluid path between the drug storage device 4 and the needle device 5.

[0060] As shown in Figures 7 and 8, the safety valve 7 includes a valve body 71, a diaphragm 72, and a sealing ring 73. The valve body 71 is provided with a liquid outlet 74, which is in communication with the soft needle 56 of the needle device 5. The sealing ring 73 and the diaphragm 72 are sequentially arranged on the valve body 71, with the liquid outlet 74 located in the middle of the sealing ring 73. The side of the diaphragm 72 facing away from the sealing ring 73 is in communication with the drug storage device 4. Specifically, an annular receiving groove 76 is provided on one side of the valve body 71. The liquid outlet 74 and the annular receiving groove 76 are arranged coaxially. The sealing ring 73 is embedded in the annular receiving groove 76, and the diaphragm 72 is attached to the sealing ring 73.

[0061] The diaphragm 72 is provided with a liquid inlet hole 721, the sealing ring 73 is provided with a flow limiting hole 731, and the valve body 71 is provided with a guide groove 75. The liquid inlet hole 721, the flow limiting hole 731 and the guide groove 75 are connected in sequence.

[0062] When the safety valve 7 is in the open state, a liquid outlet cavity is formed between the diaphragm 72 and the liquid outlet 74, and the guide groove 75 is connected to the liquid outlet cavity. The liquid in the drug storage device 4 flows into the guide groove 75 through the liquid inlet hole 721 on the diaphragm 72 and the flow-limiting hole 731 on the sealing ring 73. The central portion of the annular receiving groove 76 on the valve body 71 is a sealing boss structure 77. The sealing boss structure 77 is circular and gradually concave from its circumferential edge to its center to form an arc-shaped sealing surface. The gap between the arc-shaped sealing surface of the sealing boss structure 77 and the diaphragm 72 is the liquid outlet cavity. The guide groove 75 extends from the annular receiving groove 76 into the sealing boss structure 77. The liquid in the drug storage device 4 passes through the liquid inlet hole 721, the flow-limiting hole 731, and the guide groove 75 into the liquid outlet cavity, and then enters the needle device 5 through the liquid outlet 74, thereby completing the injection of the liquid.

[0063] When the coupling fails, the piston body 31 is pushed quickly, and the pressure on the side of the diaphragm 72 close to the medicine storage device 4 suddenly increases under the action of the liquid inlet hole 721 and the flow limiting hole 731, causing the diaphragm 72 to deform toward the liquid outlet 74 until the diaphragm 72 is completely in contact with the arc-shaped sealing surface of the sealing boss structure 77. At this time, the diaphragm 72 is in contact with the liquid outlet 74 and completely covers the liquid outlet 74. The safety valve 7 is in a closed state and the medicine cannot flow out.

[0064] Thus, when coupling assembly 12 fails, the restraint on the force storage mechanism is suddenly lost, piston body 31 is pushed at an extremely high speed, and the surface pressure of diaphragm 72 near drug storage device 4 increases suddenly under the restriction of flow restriction hole 731, causing diaphragm 72 to deform toward liquid outlet 74. The arc-shaped sealing surface of diaphragm 72, which contacts sealing boss structure 77, covers liquid outlet 74, sealing it and preventing the drug from flowing out. The use of thin film safety valve 7 solves the safety problem of equipment failure.

[0065] According to the present invention, an injection method of a continuous micro-dosing device is provided, and the injection method comprises the following steps:

[0066] Step S1: Fill a sufficient amount of liquid medicine into the medicine storage device 4.

[0067] Step S2: The control device 6 obtains an injection instruction or injection program input from the outside.

[0068] Step S3 , the control device 6 starts to control the force release device 1 to release a specified piston stroke, and the force storage device 2 pushes the piston push rod device 3 to move the specified piston stroke into the drug storage device 4 to complete the quantitative injection.

[0069] Specifically, before use, the continuous micro-dosing device is empty of liquid medicine. The user is required to inject the liquid medicine into the drug storage cavity 41 using a syringe. Therefore, a liquid injection hole is reserved on the sidewall of the drug storage cavity 41 at the end of the piston's extension stroke. During the injection of the liquid medicine into the drug storage cavity 41, the piston body 31 of the drug storage device moves backward as the liquid medicine is injected, compressing the compression spring 21 until a sufficient amount of liquid medicine is added to the drug storage cavity 41. When an injection is required, the user can send a specific infusion instruction to the control device 6 via Bluetooth communication or other means. Upon receiving the specific infusion instruction, the control device 6 sends a corresponding electric pulse signal to the fixed coil 111, causing the permanent magnet 112 and the output gear 113 to rotate a certain angle. The output gear 113 releases a certain length of the pull wire 125 via the gear set 121, thereby releasing the specified piston stroke. The specified piston stroke is now the same as the length of the release pull wire 125. The compressed compression spring 21 resets, pushing the piston push rod assembly 3 into the drug storage device 4 to move the specified piston stroke, completing the quantitative injection.

[0070] Example 2

[0071] Based on Example 1, as shown in Figures 9, 10 and 11, according to a continuous micro-dosing device provided by the present invention, the present application also proposes a feasible combination of a piston push rod device 3, a force storage device 2 and a force storage release device 1, the force storage release device 1 includes a rotating magnetic brake assembly 11 and a coupling assembly 12, the rotating magnetic brake assembly 11 is electrically connected to the control device 6, the rotating magnetic brake assembly 11 controls the piston stroke of the piston push rod device 3 through the coupling assembly 12, and the force storage device 2 outputs a rotational torque to the piston push rod device 3.

[0072] More specifically, the rotating magnetic brake assembly 11 includes a fixed coil 111 and a rotatably mounted permanent magnet 112. The permanent magnet 112 is radially magnetized. The magnetic field generated by the fixed coil 111 interacts with the radial magnetic field of the permanent magnet 112 to drive the permanent magnet 112 to rotate or position. An output gear 113 is fixedly mounted on the permanent magnet 112. The fixed coil 111 includes a coil and a fixed bracket. The coil is wound on the fixed bracket, which is fixedly mounted on the housing 8 via fasteners. The housing 8 is also fixedly mounted with a magnetic conductive sheet 114 via fasteners. The magnetic conductive sheet 114 is provided with a limiting hole 115 that allows the permanent magnet 112 to rotate and position. The shape of the limiting hole 115 enables the permanent magnet 112 to be positioned by the limiting hole. The permanent magnet 112 is cylindrical in shape. The cylindrical permanent magnet 112 is placed in the limiting hole 115 and is rotatably mounted on the housing 8 via a coaxial rotating shaft. Magnetic sheet 114 can be used to generate a specific magnetic field, such as an alternating magnetic field. The magnetic field generated by fixed coil 111 interacts with the magnetic field of permanent magnet 112, causing permanent magnet 112 to rotate a certain angle, particularly 180 degrees. Output gear 113 is coaxially mounted on permanent magnet 112, and rotation of permanent magnet 112 drives output gear 113 to rotate.

[0073] The control device 6 includes a circuit board 61, on which a communication module, a data processing module, a data storage module and a signal conversion module are integrated. The signal conversion module and the communication module are electrically connected, and the circuit board 61 is electrically connected to the fixed coil 111. The communication module of the control device 6 can receive external wired or wireless infusion command signals or infusion programs. According to the received infusion information, the data processing module can automatically control the signal conversion module to generate corresponding electric pulse signals as required. The electric pulse signals are transmitted to the fixed coil 111 to control the permanent magnet 112 to rotate a certain angle, thereby controlling the output gear 113 to rotate a certain angle.

[0074] Coupling assembly 12 includes a gear set 121, which comprises a plurality of meshing gears. Each gear in gear set 121 is rotationally connected to housing 8 via a rotating shaft. Gear set 121 includes at least one starting transmission gear 122 and at least one final transmission gear 123. Output gear 113 meshes with starting transmission gear 122 of gear set 121, and final transmission gear 123 of gear set 121 is provided with a worm 126. At least one intermediate transmission gear is disposed between starting transmission gear 122 and final transmission gear 123. The intermediate transmission gear meshes with starting transmission gear 122 and another intermediate transmission gear, with final transmission gear 123 and another intermediate transmission gear, or with two other intermediate transmission gears.

[0075] The force storage device 2 outputs rotational torque and includes a first torsion spring 22, which is in a compressed state. The piston push rod device 3 includes a piston body 31, a screw 32, a sleeve assembly 34, and a worm gear 33. The piston body 31 is disposed within the drug storage device 4. One end of the screw 32 is fixedly connected to the piston body 31, and the other end of the screw 32 extends into the sleeve assembly 34 and is threadedly connected to the inner wall of the sleeve assembly 34. The worm gear 33 is fixedly connected to the outer wall of the sleeve assembly 34 and meshes with the worm 126. One end of the first torsion spring 22 is fixedly connected to the sleeve assembly 34, and the other end of the first torsion spring 22 is fixedly connected to the housing 8 of the injection device.

[0076] Furthermore, the sleeve assembly 34 includes a screw sleeve 341, a worm gear sleeve 342, and a locking assembly 35. The screw sleeve 341 extends into the worm gear sleeve 342, and the outer wall of the screw sleeve 341 and the inner wall of the worm gear sleeve 342 slide together along the axial direction of the sleeve assembly 34. The locking assembly 35 fixedly connects the screw sleeve 341 and the worm gear sleeve 342. Before the locking assembly 35 fixedly connects the screw sleeve 341 and the worm gear sleeve 342, the screw sleeve 341 can slide along the axis of the sleeve assembly 34 on the worm gear sleeve 342. After the locking assembly 35 fixedly connects the screw sleeve 341 and the worm gear sleeve 342, the screw sleeve 341 and the worm gear sleeve 342 do not produce relative movement.

[0077] The locking assembly 35 includes a locking steel ball 351 and a locking slot 352. The locking slot 352 is fixedly connected to the worm gear sleeve 342. The screw sleeve 341 passes through the locking slot 352 and extends into the worm gear sleeve 342. The locking steel ball 351 is disposed on the outer surface of the screw sleeve 341. A receiving groove 353 with a gradually decreasing diameter is provided on the side of the locking slot 352 near the locking steel ball 351. The locking steel ball 351 fits into the receiving groove 353. The receiving groove 353 is formed by the inner wall of the locking slot 352 and the outer wall of the screw sleeve 341. The cross-section of the receiving groove 353 is approximately V-shaped. When the locking steel ball 351 enters the locking slot 352 a certain distance and reaches a gap smaller than the diameter of the locking steel ball 351, the locking steel ball 351, the locking slot 352, and the screw sleeve 341 are locked together, and the screw sleeve 341 and the worm gear sleeve 342 are locked together.

[0078] Furthermore, a locking trigger spring 354 is coaxially mounted on the screw sleeve 341. This spring is located on the side of the locking steel ball 351 facing away from the locking slot 352. The locking trigger spring 354 includes a semicircular groove that engages with the locking steel ball 351. One or more locking steel balls 351 are evenly spaced around the central axis of the screw sleeve 341. The semicircular grooves on the locking trigger spring 354 correspond to the locking steel balls 351. A sleeve lock signal switch 81 is provided on the housing 8.

[0079] Before use, there is no medicine liquid in the medicine storage device 4. The user needs to use a syringe to inject the medicine liquid into the medicine storage cavity 41. At this time, the piston body 31 will move backward with the injection of the medicine liquid. The screw rod 32 and the screw rod sleeve 341 connected to the piston body 31 need to slide freely backward in the worm gear sleeve 342. When the injection starts, the worm gear sleeve 342 and the screw rod sleeve 341 must be locked and cannot slide freely. Only then can the screw rod 32 push the piston body 31 forward to inject the medicine liquid.

[0080] When the turbine starts to rotate during injection, the locking trigger spring 354 rotates along with the turbine. When the sleeve locking signal switch 81 rotates to the point where it cannot block the locking trigger spring 354, the locking trigger spring 354 pushes the locking steel ball 351 into the locking groove 352. The gap between the locking groove 352 and the screw sleeve 341 is V-shaped, and the gap between the locking steel ball 351 and the screw sleeve 341 decreases as it moves into the locking groove 352. When the locking steel ball 351 enters the locking groove 352 a certain distance and reaches a point where the gap is smaller than the diameter of the locking steel ball 351, the locking steel ball 351, the locking groove 352, and the screw sleeve 341 are locked together, and the screw sleeve 341 is locked with the worm gear sleeve 342. This solves the problem of the worm gear sleeve 342 and the screw sleeve 341 needing to slide freely during filling but being locked during injection.

[0081] Furthermore, a guide rod 36 is fixedly provided on the piston body 31, and the length direction of the guide rod 36 is parallel to the length direction of the screw rod 32. A guide seat 82 is provided on the housing 8, and the guide rod 36 horizontally passes through the guide seat 82 and slides therewith.

[0082] According to the present invention, an injection method of a continuous micro-dosing device is provided, and the injection method comprises the following steps:

[0083] Step S1: Fill a sufficient amount of liquid medicine into the medicine storage device 4.

[0084] Step S2: The control device 6 obtains an injection instruction or injection program input from the outside.

[0085] Step S3 , the control device 6 starts to control the force release device 1 to release a specified piston stroke, and the force storage device 2 pushes the piston push rod device 3 to move the specified piston stroke into the drug storage device 4 to complete the quantitative injection.

[0086] Step S3 includes the following sub-steps:

[0087] Step S3.1: The control device 6 converts the externally input injection instruction or injection program into a series of corresponding electric pulse signals and transmits them to the fixed coil.

[0088] Step S3.2, the fixed coil 111 drives the permanent magnet 112 to make corresponding movements to rotate the output gear 113, and drives the worm gear 33 to rotate through the gear set 121, and the screw sleeve 341 moves into the worm gear sleeve 342 until the locking steel ball 351 is embedded in the receiving groove 353 of the locking slot 352 to lock the screw sleeve 341 and the worm gear sleeve 342.

[0089] Step S3.3: The control device 6 obtains the locking signals of the screw sleeve 341 and the worm sleeve 342, and releases the piston stroke contained in the externally input injection instruction through the coil, the output gear 113 and the gear set 121 to complete the quantitative injection.

[0090] During initial installation, the force release device 1, the force storage device 2, and the piston push rod device 3 are installed in place. Because the three are coupled and static, the piston is lifted to the top of the medicine storage cavity 41. The user uses a syringe to inject insulin into the medicine storage cavity 41 through the filling hole. The piston body 31 is forced to retreat, triggering the power switch to connect the circuit. After the filling is completed, the user issues an infusion instruction through the controller via Bluetooth communication. After receiving the instruction, the control device 6 sends a corresponding electric pulse. The rotating magnetic brake assembly 11 is angularly offset by the electric pulse, and the output gear 113 also rotates by a corresponding angle. The corresponding angle is transmitted through the coupling mechanism, and the locking assembly 35 is activated to lock the screw sleeve 341 and the turbine sleeve 342, so that the force storage device 2 can push the piston body 31 to make the corresponding movement. The squeezed liquid medicine flows out of the needle tip of the soft needle 56 through the pipeline.

[0091] In the description of this application, it should be understood that the terms "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application.

[0092] The above describes specific embodiments of the present invention. It should be understood that the present invention is not limited to the specific embodiments described above, and those skilled in the art may make various changes or modifications within the scope of the claims, which do not affect the essence of the present invention. The embodiments of this application and the features in the embodiments may be combined with each other in any manner unless there is a conflict.

Claims

1. A continuous micro-dosing device, characterized in that: It comprises a needle device (5), a medicine storage device (4), a piston push rod device (3), a force storage device (2), a force storage release device (1) and a control device (6); Under the action of the control device (6), the force storage release device (1) releases a specified piston stroke, the force storage device (2) pushes the piston push rod device (3) to move a specified piston stroke into the medicine storage device (4), and the medicine liquid in the medicine storage device (4) is discharged through the needle device (5).

2. The continuous micro-dosing device according to claim 1, characterized in that: The force storage release device (1) comprises a rotating magnetic brake component (11) and a coupling component (12); the rotating magnetic brake component (11) is electrically connected to a control device (6); the rotating magnetic brake component (11) controls the piston stroke of a piston push rod device (3) via the coupling component (12); and the force storage device (2) outputs a rotational torque or a linear thrust to the piston push rod device (3).

3. The continuous micro-dosing device according to claim 2, characterized in that: The rotating magnetic brake assembly (11) comprises a fixed coil (111) and a rotatably arranged permanent magnet (112), wherein the permanent magnet (112) is radially magnetized, and the magnetic field generated by the fixed coil (111) interacts with the radial magnetic field of the permanent magnet (112) to drive the permanent magnet (112) to rotate or position, and an output gear (113) is fixedly arranged on the permanent magnet (112); The force storage device (2) comprises an elastic member, and the elastic member is in a compressed state; The coupling assembly (12) comprises a gear set (121), the output gear (113) meshes with a transmission start end gear (122) of the gear set (121), a winding wheel (124) is provided on the transmission end gear (123) of the gear set (121), a pulling wire (125) is wound around the winding wheel (124), and the pulling wire (125) extends to the piston push rod device (3) along the extension direction of the elastic member through an end of the elastic member away from the piston push rod device (3) and is connected to the piston push rod device (3).

4. The continuous micro-dosing device according to claim 2, characterized in that: The rotating magnetic brake assembly (11) comprises a fixed coil (111) and a rotatably arranged permanent magnet (112); the permanent magnet (112) is radially magnetized; the magnetic field generated by the fixed coil (111) interacts with the radial magnetic field of the permanent magnet (112) to drive the permanent magnet (112) to rotate or position; and an output gear (113) is fixedly arranged on the permanent magnet (112); The force storage device (2) comprises a first torsion spring (22), wherein the first torsion spring (22) is in a compressed state; The coupling assembly (12) comprises a gear set (121), the output gear (113) meshes with a transmission start-end gear (122) of the gear set (121), and a worm (126) is provided on the transmission end gear (123) of the gear set (121); The piston push rod device (3) comprises a piston body (31), a screw rod (32), a sleeve assembly (34) and a worm gear (33); the piston body (31) is arranged in the medicine storage device (4); one end of the screw rod (32) is fixedly connected to the piston body (31); the other end of the screw rod (32) extends into the sleeve assembly (34) and is threadedly connected to the inner wall of the sleeve assembly (34); the worm gear (33) is fixedly connected to the outer wall of the sleeve assembly (34); and the worm gear (33) is meshed with the worm (126); One end of the first torsion spring (22) is fixedly connected to the sleeve assembly (34), and the other end of the first torsion spring (22) is fixedly connected to the housing (8).

5. The continuous micro-dosing device according to claim 4, characterized in that: The sleeve assembly (34) comprises a screw sleeve (341), a worm gear sleeve (342) and a locking assembly (35); the screw sleeve (341) extends into the worm gear sleeve (342), and the outer wall of the screw sleeve (341) and the inner wall of the worm gear sleeve (342) are slidably matched along the axial direction of the sleeve assembly (34); The locking assembly (35) fixedly connects the screw sleeve (341) and the worm gear sleeve (342); the screw (32) extends into the screw sleeve (341); and the worm gear (33) is arranged on the outer wall of the worm gear sleeve (342).

6. The continuous micro-dosing device according to claim 5, characterized in that: The locking assembly (35) comprises a locking steel ball (351) and a locking slot (352), the locking slot (352) being relatively fixedly connected to the worm gear sleeve (342), and the screw sleeve (341) passes through the locking slot (352) and extends into the worm gear sleeve (342); The locking steel ball (351) is arranged on the outer surface of the screw sleeve (341), and a receiving groove (353) with a gradually decreasing diameter is arranged on the side of the locking slot (352) close to the locking steel ball (351), and the locking steel ball (351) is embedded and matched with the receiving groove (353).

7. The continuous micro-dosing device according to claim 1, characterized in that: A safety valve (7) is provided on the communication pipeline between the drug storage device (4) and the needle device (5), the safety valve (7) comprising a valve body (71), a diaphragm (72) and a sealing ring (73), the valve body (71) being provided with a liquid outlet (74), the liquid outlet (74) being communicated with the needle device (5); The sealing ring (73) and the diaphragm (72) are sequentially arranged on the valve body (71), the liquid outlet (74) is located in the middle of the sealing ring (73), and the side of the diaphragm (72) away from the sealing ring (73) is connected to the drug storage device (4); The diaphragm (72) is provided with a liquid inlet hole (721), the sealing ring (73) is provided with a flow limiting hole (731), and the valve body (71) is provided with a flow guide groove (75), and the liquid inlet hole (721), the flow limiting hole (731) and the flow guide groove (75) are sequentially connected; When the safety valve (7) is in an open state, a liquid outlet cavity is formed between the diaphragm (72) and the liquid outlet (74), and the guide groove (75) is in communication with the liquid outlet cavity; When the safety valve (7) is in a closed state, the diaphragm (72) seals the liquid outlet (74).

8. The continuous micro-dosing device according to claim 1, characterized in that: The needle device (5) comprises a vertical needle seat (51), a rotating needle seat (52), a hard needle seat (53), a soft needle seat (54), a hard needle (55) and a soft needle (56); the rotating needle seat (52) is rotatably and liftably arranged in the vertical needle seat (51); A rotating needle seat guide groove (57) is provided on the outer wall of the rotating needle seat (52), and the rotating needle seat guide groove (57) spirally extends downward from the upper end of the rotating needle seat (52) to the lower end of the rotating needle seat (52), and then spirally extends upward from the lower end of the rotating needle seat (52) to the upper end of the rotating needle seat (52); A vertical needle seat guide groove (58) is vertically arranged on the inner wall of the vertical needle seat (51), and the soft needle seat (54) and the hard needle seat (53) are slidably arranged in the vertical needle seat guide groove (58) from bottom to top in sequence, and a soft needle (56) is connected to the bottom of the soft needle seat (54), and a hard needle (55) is connected to the bottom of the hard needle seat (53). The hard needle (55) passes through the soft needle seat (54) and the soft needle (56) in sequence from top to bottom, and the hard needle seat (53) is slidably arranged in the rotating needle seat guide groove (57).

9. An injection method of a continuous micro-dosing device, characterized in that: Using the continuous micro-dosing device according to any one of claims 1 to 8, the injection method comprises the following steps: Step S1, adding a sufficient amount of liquid medicine into the medicine storage device (4); Step S2, the control device (6) obtains an injection instruction or injection program input from the outside; Step S3, the control device (6) starts to control the force storage release device (1) to release a specified piston stroke, and the force storage device (2) pushes the piston push rod device (3) to move the specified piston stroke into the medicine storage device (4), thereby completing the quantitative injection.

10. The injection method of the continuous micro-dosing device according to claim 9, characterized in that: Step S3 includes the following sub-steps: Step S3.1, the control device (6) converts the injection instruction or injection program input from the outside into a series of corresponding electric pulse signals and transmits them to the fixed coil (11); Step S3.2, the fixed coil (111) drives the permanent magnet (112) to make corresponding movements to rotate the output gear (113), and drives the worm wheel (33) to rotate through the gear set (121), and the screw sleeve (341) moves into the worm wheel sleeve (342) until the locking steel ball (351) is embedded in the receiving groove (353) of the locking slot (352) to lock the screw sleeve (341) and the worm wheel sleeve (342); Step S3.3, the control device (6) obtains the locking signals of the screw sleeve (341) and the worm sleeve (342), and releases the piston stroke contained in the externally input injection instruction through the fixed coil (111), the output gear (113) and the gear set (121), thereby completing the quantitative injection.

Images