Continuous micro-dose delivery device and injection method

Abstract

This invention provides a continuous micro-dose delivery device and injection method, including a needle device, a drug storage device, a piston pusher device, a power storage device, a power release device, and a control device. Under the action of the control device, the power release device releases a specified piston stroke, and the power storage device pushes the piston pusher device to move a specified piston stroke into the drug storage device, through which the drug solution in the drug storage device is discharged via the needle device. Using the power storage device as a power source, the piston is driven by rotation or direct push. The required number of pulses is calculated based on the dosage to be infused or the distance the piston travels, and the control device precisely controls the power release device to release the specified piston stroke, thus improving the accuracy of the drug delivery dosage. A coupling assembly consisting of multiple gears connects the rotary magnetic brake assembly and the piston pusher device, enabling the rotary magnetic brake assembly to control a larger force from the power storage device with a smaller force.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a continuous micro-dose delivery device and injection method. Background Technology

[0002] Continuous dosing refers to administering a drug continuously every day to maintain an effective blood concentration. In current clinical practice, continuous dosing is frequently used in treatments 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 glucose 1-2 times a day; the other is intensive treatment, which involves monitoring blood glucose multiple times a day and continuously infusing insulin in a manner that mimics the way pancreatic islet cells secrete insulin, in order to bring blood glucose as close to normal levels as possible. This method is mostly achieved using an insulin pump.

[0004] In 1993, the Diabetes Control and Complications Trial (DCCT) conducted a large-scale, long-term clinical trial using the two methods described above to observe the benefits of intensive glycemic control. The results showed that the average glycated hemoglobin (HbA1c) in the well-controlled group was 2% lower than in the poorly controlled group, significantly reducing the risk of chronic diabetic complications: the risk of diabetic retinopathy decreased by approximately 76%, and the risk of kidney and neuropathy was reduced to the same extent.

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

[0006] Existing automated insulin injection devices are difficult to control precisely, have complex structures, and are costly to manufacture, thus requiring improvement. Summary of the Invention

[0007] In view of the deficiencies in the prior art, the purpose of this invention is to provide a continuous micro-dose delivery device and injection method.

[0008] A continuous micro-dose delivery device according to the present invention includes a needle device, a drug storage device, a piston pusher device, a power storage device, a power storage release device, and a control device; under the action of the control device, the power storage release device releases a specified piston stroke, the power storage device pushes the piston pusher 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 energy 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. The energy storage device outputs rotational torque or linear thrust to the piston push rod device.

[0010] Preferably, the rotary magnetic brake assembly includes a fixed coil and a rotatably mounted 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 be positioned. An output gear is fixedly mounted on the permanent magnet. The energy storage device includes an elastic element in a compressed state. The coupling assembly includes a gear set. The output gear meshes with the transmission start gear of the gear set. A winding wheel is mounted on the transmission end gear of the gear set. A pull wire is wound on the winding wheel. The pull wire extends from the end of the elastic element away from the piston push rod device along the extension and retraction direction of the elastic element to the piston push rod device and connects to the piston push rod device.

[0011] Preferably, the rotary magnetic brake assembly includes a fixed coil and a rotatably mounted permanent magnet. The permanent magnet is radially magnetized, and 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 be positioned. An output gear is fixedly mounted on the permanent magnet. The energy storage device includes a first torsion spring, which is in a compressed state. The coupling assembly includes a gear set, and the output gear meshes with the transmission start gear of the gear set. A worm gear is mounted on the transmission end gear of the gear set. The piston push rod device includes a piston, a lead screw, a sleeve assembly, and a worm wheel. The piston is disposed inside the drug storage device. One end of the lead screw is fixedly connected to the piston body, and the other end of the lead screw 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 meshes 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 lead screw sleeve, a worm gear sleeve, and a locking assembly. The lead screw sleeve extends into the worm gear sleeve, and the outer wall of the lead screw sleeve and the inner wall of the worm gear sleeve slide in axial engagement along the sleeve assembly. The locking assembly fixes the lead screw sleeve and the worm gear sleeve together. The lead screw extends into the lead screw sleeve, and the worm gear is disposed on the outer wall of the worm gear sleeve.

[0013] Preferably, the locking assembly includes a locking ball and a locking groove. The locking groove is fixedly connected to the worm gear sleeve. The lead screw sleeve passes through the locking groove and extends into the worm gear sleeve. The locking ball is disposed on the outer surface of the lead screw sleeve. The locking groove has a receiving groove with a gradually decreasing diameter on the side near the locking ball. The locking 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. The safety valve includes a valve body, a diaphragm, and a sealing ring. The valve body has a liquid outlet that communicates with the needle device. The sealing ring and the diaphragm are sequentially arranged on the valve body. The liquid outlet is located in the middle of the sealing ring, and the side of the diaphragm facing away from the sealing ring communicates with the drug storage device. The diaphragm has a liquid inlet, the sealing ring has a flow limiting orifice, and the valve body has a flow guide groove. The liquid inlet, the flow limiting orifice, and the flow guide groove are sequentially connected. When the safety valve is in the open state, a liquid outlet cavity is formed between the diaphragm and the liquid outlet, and the flow guide groove communicates with the liquid outlet cavity. When the safety valve is in the 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. The rotating needle seat is rotatably and vertically disposed within the vertical needle seat. A rotating needle seat guide groove is provided on the outer wall of the rotating needle seat, which spirally extends downward from the upper end of the rotating needle seat to the lower end, and then spirally extends upward from the lower end of the rotating needle seat to the upper end. A vertical needle seat guide groove is vertically disposed on the inner wall of the vertical needle seat. The soft needle seat and the hard needle seat are slidably disposed in the vertical needle seat guide groove from bottom to top. A soft needle is connected to the lower part of the soft needle seat, and a hard needle is connected to the lower part of the hard needle seat. The hard needle passes through the soft needle seat and the soft needle sequentially from top to bottom, and the hard needle seat is slidably disposed within the rotating needle seat guide groove.

[0016] An injection method for a continuous micro-dose delivery device provided by the present invention includes the following steps:

[0017] Step S1: Add sufficient liquid medicine to the medicine storage device;

[0018] Step S2: The control device receives an externally input injection command or injection program;

[0019] Step S3: The control device starts the control accumulator release device to release the specified piston stroke. The accumulator pushes the piston rod device to move the specified piston stroke into the drug 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 command or injection program into a series of corresponding electrical pulse signals and transmits them to the fixed coil;

[0022] Step S3.2: The fixed coil drives the permanent magnet to make corresponding movements to make the output gear rotate, and drives the worm gear to rotate through the gear set. The lead screw sleeve moves into the worm gear sleeve until the locking steel ball is embedded in the receiving groove of the locking slot, so that the lead screw sleeve and the worm gear sleeve are locked together.

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

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

[0025] 1. This invention uses a power storage device as a power source to drive the piston by rotation or direct push. The required number of pulses is calculated based on the dosage to be infused or the distance the piston moves. The power storage device is then precisely controlled by the control device to release the specified piston stroke, which helps to improve the accuracy of the drug delivery dosage.

[0026] 2. The present invention connects the rotary magnetic brake assembly and the piston push rod device through a coupling assembly composed of multiple gears, thereby enabling the rotary magnetic brake assembly to control a larger force of the energy storage device with a smaller force.

[0027] 3. The present invention enables the lead screw and lead screw sleeve to move into the worm sleeve when the drug solution is injected into the drug storage cavity through the sleeve assembly. During injection, the worm wheel rotates and locks the lead screw sleeve and worm sleeve with the help of the locking assembly, which solves the problem that the worm wheel sleeve and the lead screw sleeve need to slide freely during filling the drug but are locked to each other during injection.

[0028] 4. In the event of a safety valve coupling failure, the pressure on the diaphragm near the drug storage device increases suddenly under the restriction of the flow limiting orifice, causing the diaphragm to deform towards the liquid outlet. The arc-shaped sealing surface of the diaphragm attached to the sealing boss structure covers the liquid outlet, sealing it and preventing the liquid from flowing out, thus solving the safety problem when the equipment fails. Attached Figure Description

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

[0030] Figure 1 This is a schematic diagram illustrating the overall structure of the injection device, which is the main feature of this invention.

[0031] Figure 2 This is an exploded view of the overall structure of the rotary magnetic brake assembly, which is the main feature of this invention.

[0032] Figure 3 This is a schematic diagram illustrating the overall structure of the rotary magnetic brake assembly, which is the main feature of this invention.

[0033] Figure 4 This is a schematic diagram illustrating the cooperative structure of the coupling component and the energy storage device in Embodiment 1 of the present invention.

[0034] Figure 5 This is an exploded view illustrating the overall structure of the needle device of this invention.

[0035] Figure 6 This is a schematic diagram illustrating the needle holder structure of the needle device, which is the main feature of this invention.

[0036] Figure 7 This is an exploded view illustrating the overall structure of the safety valve, which is the main feature of this invention.

[0037] Figure 8 This is a cross-sectional view that mainly illustrates the overall structure of the safety valve in this invention;

[0038] Figure 9 This is an exploded view illustrating the overall structure of the injection device in Embodiment 2 of the present invention;

[0039] Figure 10 This is an exploded view illustrating the overall structure of the locking component, which is the main feature of this invention.

[0040] Figure 11 This is a cross-sectional view that mainly illustrates the overall structure of the piston push rod device of this invention.

[0041] As shown in the figure:

[0042] Energy storage and release device 1, lead screw 32, rotating needle seat guide groove 57

[0043] Rotary magnetic brake assembly 11, worm gear 33, vertical pin seat guide groove 58

[0044] Fixed coil 111, sleeve assembly 34, second torsion spring 59

[0045] Permanent magnet 112, lead screw sleeve 341, needle insertion button 510

[0046] Output gear 113, worm gear sleeve 342, control device 6

[0047] Magnetic sheet 114, Locking assembly 35, Circuit board 61

[0048] Limit hole 115, locking ball 351, safety valve 7

[0049] Coupling assembly 12, locking slot 352, valve body 71

[0050] Gear assembly 121, receiving groove 353, diaphragm 72

[0051] Transmission starting gear 122, locking trigger spring 354, liquid inlet 721

[0052] Transmission end gear 123, guide rod 36, sealing ring 73

[0053] Winding reel 124, medicine storage device 4, flow limiting orifice 731

[0054] Pull wire 125, drug storage cavity 41, liquid outlet 74

[0055] Worm 126, Needle device 5, Flow guide groove 75

[0056] Guide post 127, Vertical needle seat 51, Annular receiving groove 76

[0057] Energy storage device 2, rotating needle seat 52, sealing boss structure 77

[0058] Compression spring 21, hard needle seat 53, housing 8

[0059] First torsion spring 22, soft needle seat 54, sleeve locking signal switch 81, piston push rod device 3, hard needle 55, guide seat 82

[0060] Piston body 31, soft needle 56 Detailed Implementation

[0061] The present invention will now be described in detail with reference to specific embodiments. These embodiments will help those skilled in the art to further understand the present invention, but do not limit the invention in any way. It should be noted that those skilled in the art can make several changes and improvements without departing from the concept of the present invention. These all fall within the protection scope of the present invention.

[0062] Example 1

[0063] like Figure 1As shown, a continuous micro-dose administration device according to the present invention includes a needle device 5, a drug storage device 4, a piston pusher device 3, a power storage device 2, a power storage release device 1, and a control device 6. Under the action of the control device 6, the power storage release device 1 releases a specified piston stroke, and the power storage device 2 pushes the piston pusher device 3 to move a specified piston stroke into the drug storage device 4, and the drug solution in the drug storage device 4 is discharged through the needle device 5.

[0064] The specified piston stroke in this application refers to the infusion command issued by the operator to the control device 6 via Bluetooth communication or other information transmission methods. After receiving the infusion command, the control device 6 sends a corresponding electrical pulse to the accumulator release device 1 to release the specified piston stroke. This allows the accumulator device 2 to push the piston push rod device 3 to move the specified piston stroke into the drug storage device 4, thereby squeezing the liquid medicine in the drug storage device 4 and discharging the squeezed liquid medicine through the tubing and then through the needle of the needle device 5.

[0065] Specifically, the injection device also includes a housing 8, which serves as the mounting base for the components on the injection device and has a certain structural strength. The energy storage and release device 1 includes a rotary magnetic brake assembly 11 and a coupling assembly 12. The rotary magnetic brake assembly 11 is electrically connected to the control device 6. The rotary magnetic brake assembly 11 controls the piston stroke of the piston push rod device 3 through the coupling assembly 12. The energy storage device 2 outputs linear thrust to the piston push rod device 3.

[0066] like Figure 1 , Figure 2 , Figure 3 As shown, 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, causing the permanent magnet 112 to rotate or be positioned. 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 by fasteners. A magnetic conductive sheet 114 is also fixedly mounted on the housing 8 by fasteners. The magnetic conductive sheet 114 is provided with a limiting hole 115 that allows the permanent magnet 112 to rotate and be positioned. 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 through a coaxially arranged rotating shaft. The magnetic sheet 114 can be used to generate an alternating magnetic field. The magnetic field generated by the fixed coil 111 can interact with the magnetic field of the permanent magnet 112, causing the permanent magnet 112 to rotate at a certain angle, especially 180 degrees. The output gear 113 is coaxially and firmly mounted on the permanent magnet 112. The rotation of the permanent magnet 112 can drive the output gear 113 to rotate.

[0067] It should be noted that the rotary magnetic brake assembly 11 of this application can also be a magnetic brake, electromagnetic swing fork or electromagnetic ring, etc., which are capable of outputting torque in the prior art.

[0068] The control device 6 includes a circuit board 61, which integrates a communication module, a data processing module, a data storage module, and a signal conversion module. 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 wired or wireless infusion command signals or infusion programs from the outside. According to the received infusion information, the data processing module can automatically control the signal conversion module to generate corresponding electrical pulse signals as needed. The electrical 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.

[0069] like Figure 1 , Figure 2 , Figure 3 as well as Figure 4 As shown, the coupling assembly 12 includes a gear set 121, which comprises multiple meshing gear structures. Each gear in the gear set 121 is rotatably connected to the housing 8 via a rotating shaft. The gear set 121 includes at least one transmission starting gear 122 and at least one transmission ending gear 123. The output gear 113 meshes with the transmission starting gear 122 of the gear set 121. At least one intermediate transmission gear is provided between the transmission starting gear 122 and the transmission ending gear 123. The intermediate transmission gear meshes with the transmission starting gear 122 and another intermediate transmission gear, or with the transmission ending gear 123 and another intermediate transmission gear, or with two other intermediate transmission gears.

[0070] The energy storage device 2 includes an elastic element. The elastic element is in a compressed state. The elastic element of this application outputs a linear thrust. It can be an elastic device that can store potential energy, such as a compression spring 21, a rubber band, or a compressed air spring in the prior art. The elastic element in this embodiment is preferably a compression spring 21.

[0071] A winding wheel 124 is coaxially mounted on the transmission end gear 123 of the gear set 121. A pull wire 125 is wound on the winding wheel 124. The end of the pull wire 125 away from the piston push rod device 3 extends along the extension and contraction direction of the compression spring 21 to the piston push rod device 3 and is connected to the piston push rod device 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 in a certain proportion. When it is necessary to inject medicine, the user sends a specific infusion command to the control device 6. After receiving the specific infusion command, the control device 6 sends a corresponding electrical 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 pull wire 125 through the gear set 121 to release the specified piston stroke. At this time, the specified piston stroke and the length of the released pull wire 125 are the same.

[0072] Furthermore, the gear set 121 and the compression spring 21 are arranged side by side, and the housing 8 is provided with a guide post 127. The guide post 127 is located on the side of the compression spring 21 away from the piston push rod device 3. The pull line 125 on the take-up reel first passes around the guide post 127 and then extends along the extension and retraction direction of the compression spring 21 to the piston push rod device 3 and connects with the piston push rod device 3.

[0073] The piston pusher 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 slides against 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 from leaking out from the connection between the piston body 31 and the inner wall of the drug storage cavity 41. The direction of movement of the piston body 31 in the drug storage cavity 41 is parallel to the extension and retraction direction of the compression spring 21. The compression spring 21 is connected to or pressed against 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, the piston body 31 can move a certain length into the drug storage cavity 41 under the action of the compression spring 21. It should be noted that the cross-sectional area of ​​the drug storage cavity 41 can be determined during processing. When the piston body 31 moves a certain length into the drug storage cavity 41, the volume of the drug liquid discharged when the piston body 31 moves a certain length into the drug storage cavity 41 can be calculated, thereby realizing the quantitative infusion of the drug liquid and helping to improve the accuracy of drug liquid infusion.

[0074] By means of gear set 121, the small force of the rotary magnetic brake assembly 11 can be used to control a larger force of the energy storage device 2. Under the same clinical requirements, compared with servo motors and shape memory alloys, the cost of the technical solution of this application is greatly reduced, and the power consumption required is only one-tenth or even one-hundredth, which can greatly reduce the cost of purchasing medical equipment for patients and reduce battery consumption and pollution.

[0075] like Figure 5 and Figure 6 As shown, 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 insertion 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 insertion button 510 are arranged coaxially from bottom to top inside the vertical needle seat 51. The rotating needle seat 52 is rotated and lifted inside the vertical needle seat 51, and the rotating needle seat 52 is rotatably engaged with the inner wall of the vertical needle seat 51. A rotating needle holder guide groove 57 is provided on the outer wall of the rotating needle holder 52. The rotating needle holder guide groove 57 extends spirally downward from the upper end of the rotating needle holder 52 to the lower end of the rotating needle holder 52, and then extends spirally upward from the lower end of the rotating needle holder 52 to the upper end of the rotating needle holder 52. The lower end of the second torsion spring 59 is connected or pressed to the upper end of the rotating needle holder 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 holder 52 to rotate downward in the vertical direction.

[0076] A vertical needle holder guide groove 58 is vertically arranged on the inner wall of the vertical needle holder 51. A soft needle holder 54 and a hard needle holder 53 are arranged sequentially from bottom to top within the vertical needle holder guide groove 58, and both the soft needle holder 54 and the hard needle holder 53 slide in engagement with the vertical needle holder guide groove 58. A soft needle 56 is connected below the soft needle holder 54, and a hard needle 55 is connected below the hard needle holder 53. The hard needle 55 passes through the soft needle holder 54 and the soft needle 56 sequentially from top to bottom, and the hard needle holder 53 is simultaneously slidably arranged within the rotating needle holder guide groove 57. It should be noted that the soft needle 56 is coaxially sleeved outside the hard needle 55, and the hard needle 55 provides support for the soft needle 56 when it is inserted into the skin.

[0077] Pressing the needle insertion button 510 causes the second torsion spring 59 to push the rotating needle seat 52 to rotate downwards. The hard needle seat 53 cannot move left or right under the restriction of the vertical needle seat guide groove 58. It can only slide within the rotating needle seat guide groove 57 and be pushed by the rotating needle seat guide groove 57 to move up and down within the vertical needle seat guide groove 58. When the rotating needle seat guide groove 57 rotates the first half turn, it pushes the hard needle seat 53, hard needle 55, soft needle seat 54 and soft needle 56 to move downwards together, inserting the hard needle 55 and soft needle 56 into the subcutaneous tissue. When the rotating needle seat guide groove 57 rotates the second half turn, it pushes the hard needle seat 53 to move upwards and pulls out the hard needle 55, leaving the soft needle 56 under the skin.

[0078] The soft needle 56 is connected to the drug storage cavity 41 through a pipe. A safety valve 7 is installed on the connecting pipe between the drug storage device 4 and the needle device 5. The safety valve 7 is used to connect or block the liquid path between the drug storage device 4 and the needle device 5.

[0079] like Figure 7 Figure 8 As shown, the safety valve 7 includes a valve body 71, a diaphragm 72, and a sealing ring 73. The valve body 71 has a liquid outlet 74, which communicates with the flexible 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 communicates with the drug storage device 4. Specifically, one side of the valve body 71 has an annular receiving groove 76, with the liquid outlet 74 coaxially arranged with the annular receiving groove 76. The sealing ring 73 is embedded in the annular receiving groove 76, and the diaphragm 72 is attached to the sealing ring 73.

[0080] The diaphragm 72 is provided with an 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 guiding groove 75. The inlet hole 721, the flow limiting hole 731 and the flow guiding groove 75 are connected in sequence.

[0081] When the safety valve 7 is open, a liquid outlet cavity is formed between the diaphragm 72 and the liquid outlet 74, and the guide channel 75 is connected to the liquid outlet cavity. The liquid medicine in the drug storage device 4 flows into the guide channel 75 sequentially through the inlet hole 721 on the diaphragm 72 and the flow limiting hole 731 on the sealing ring 73. The center 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 it gradually recesses from its peripheral edge to the 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 channel 75 extends from the annular receiving groove 76 into the sealing boss structure 77. The liquid medicine in the drug storage device 4 enters the liquid outlet cavity through the inlet hole 721, the flow limiting hole 731, and the guide channel 75, and then enters the needle device 5 through the liquid outlet 74, thereby completing the injection of the liquid medicine.

[0082] When the coupling fails, the piston body 31 is pushed rapidly, and the pressure on the side of the diaphragm 72 near the drug storage device 4 increases suddenly under the action of the inlet hole 721 and the flow limiting hole 731. This causes the diaphragm 72 to deform towards the 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 outlet 74 and completely covers the outlet 74. The safety valve 7 is in the closed state, and the drug cannot flow out.

[0083] This allows the system to suddenly lose its restraint on the energy storage mechanism when the coupling component 12 fails. The piston body 31 is then rapidly pushed forward, and under the constraint of the flow-limiting orifice 731, the surface pressure of the diaphragm 72 near the drug storage device 4 increases sharply. This causes the diaphragm 72 to deform towards the outlet 74, and the arc-shaped sealing surface of the sealing boss structure 77 covers the outlet 74, sealing it and preventing the drug from flowing out. By adopting the structure of the diaphragm safety valve 7, the safety problem in the event of equipment failure is solved.

[0084] An injection method for a continuous micro-dose delivery device provided by the present invention includes the following steps:

[0085] Step S1: Add sufficient medicine solution to the medicine storage device 4.

[0086] Step S2: Control device 6 receives externally input injection instructions or injection procedures.

[0087] Step S3: The control device 6 starts the control accumulator release device 1 to release the specified piston stroke, and the accumulator device 2 pushes the piston push rod device 3 to move into the drug storage device 4 to move the specified piston stroke, thus completing the quantitative injection.

[0088] Specifically, before use, the continuous micro-dose delivery device is empty of medication. The user needs to inject the medication into the storage cavity 41 using a syringe. Therefore, an injection hole is provided on the side wall at the end of the piston extension stroke of the storage cavity 41. During the injection of medication into the storage cavity 41, the piston body 31 of the storage device moves backward as the medication is injected, and the compression spring 21 is compressed until the storage cavity 41 is filled with sufficient medication. When injection is needed, the user can send a specific infusion command to the control device 6 via Bluetooth communication or other means. After receiving the specific infusion command, the control device 6 sends a corresponding electrical pulse signal to the fixed coil 111, causing the permanent magnet 112 and the output gear 113 to rotate at a certain angle. The output gear 113 releases a certain length of pull wire 125 through the gear set 121 to release the specified piston stroke. At this time, the specified piston stroke and the length of the release pull wire 125 are the same. The compression spring 21, which is in a compressed state, returns to its original position and pushes the piston push rod device 3 to move into the storage device 4 for the specified piston stroke, completing the quantitative injection.

[0089] Example 2

[0090] Based on Example 1, such as Figure 9 , Figure 10 as well as Figure 11As shown, according to the continuous micro-dose delivery device provided by the present invention, this application also proposes a feasible combination of piston push rod device 3, power storage device 2 and power storage release device 1. The power storage release device 1 includes a rotary magnetic brake assembly 11 and a coupling assembly 12. The rotary magnetic brake assembly 11 is electrically connected to the control device 6. The rotary magnetic brake assembly 11 controls the piston stroke of the piston push rod device 3 through the coupling assembly 12. The power storage device 2 outputs rotational torque to the piston push rod device 3.

[0091] 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, causing the permanent magnet 112 to rotate or be positioned. 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 by fasteners. A magnetic conductive sheet 114 is also fixedly mounted on the housing 8 by fasteners. The magnetic conductive sheet 114 is provided with a limiting hole 115 that allows the permanent magnet 112 to rotate and be positioned. The shape of the limiting hole 115 enables the permanent magnet to be positioned. 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 by a coaxially mounted rotating shaft. The magnetic sheet 114 can be used to generate a specific magnetic field, such as an alternating magnetic field. The magnetic field generated by the fixed coil 111 can interact with the magnetic field of the permanent magnet 112, causing the permanent magnet 112 to rotate at a certain angle, especially 180 degrees. The output gear 113 is coaxially and securely mounted on the permanent magnet 112. The rotation of the permanent magnet 112 can drive the output gear 113 to rotate.

[0092] The control device 6 includes a circuit board 61, which integrates a communication module, a data processing module, a data storage module, and a signal conversion module. 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 wired or wireless infusion command signals or infusion programs from the outside. According to the received infusion information, the data processing module can automatically control the signal conversion module to generate corresponding electrical pulse signals as needed. The electrical 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.

[0093] The coupling assembly 12 includes a gear set 121, which comprises multiple meshing gear structures. Each gear in the gear set 121 is rotatably connected to the housing 8 via a rotating shaft. The gear set 121 includes at least one transmission starting gear 122 and at least one transmission ending gear 123. The output gear 113 meshes with the transmission starting gear 122 of the gear set 121. A worm gear 126 is provided on the transmission ending gear 123 of the gear set 121. At least one intermediate transmission gear is provided between the transmission starting gear 122 and the transmission ending gear 123. The intermediate transmission gear meshes with the transmission starting gear 122 and another intermediate transmission gear, or with the transmission ending gear 123 and another intermediate transmission gear, or with two other intermediate transmission gears.

[0094] The power storage device 2 outputs rotational torque. The power storage device 2 includes a first torsion spring 22, which is in a compressed state. The piston push rod device 3 includes a piston body 31, a lead 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 lead screw 32 is fixedly connected to the piston body 31, and the other end of the lead 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.

[0095] Furthermore, the sleeve assembly 34 includes a lead screw sleeve 341, a worm gear sleeve 342, and a locking assembly 35. The lead screw sleeve 341 extends into the worm gear sleeve 342, and the outer wall of the lead screw sleeve 341 and the inner wall of the worm gear sleeve 342 are slidably engaged along the axial direction of the sleeve assembly 34. The locking assembly 35 fixes the lead screw sleeve 341 and the worm gear sleeve 342 together. Before the locking assembly 35 fixes the lead screw sleeve 341 and the worm gear sleeve 342 together, the lead screw sleeve 341 can slide along the axis of the sleeve assembly 34 within the worm gear sleeve 342. After the locking assembly 35 fixes the lead screw sleeve 341 and the worm gear sleeve 342 together, there is no relative movement between them.

[0096] The locking assembly 35 includes a locking ball 351 and a locking groove 352. The locking groove 352 is fixedly connected to the worm gear sleeve 342. The lead screw sleeve 341 passes through the locking groove 352 and extends into the worm gear sleeve 342. The locking ball 351 is disposed on the outer surface of the lead screw sleeve 341. The locking groove 352 has a receiving groove 353 with a gradually decreasing diameter on the side near the locking ball 351. The locking ball 351 is embedded and fitted into the receiving groove 353. The receiving groove 353 is formed by the inner wall of the locking groove 352 and the outer wall of the lead screw sleeve 341, and the cross-sectional shape of the receiving groove 353 is approximately "V". When the locking ball 351 enters the locking groove 352 and reaches a certain distance where the gap is less than the diameter of the locking ball 351, the locking ball 351, the locking groove 352, and the lead screw sleeve 341 are mutually locked, and the lead screw sleeve 341 and the worm gear sleeve 342 are mutually locked.

[0097] Furthermore, a locking trigger spring 354 is coaxially sleeved on the lead screw sleeve 341. The locking trigger spring 354 is located on the side of the locking steel ball 351 facing away from the locking slot 352, and the locking trigger spring 354 has a semi-circular 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 lead screw sleeve 341, and the semi-circular grooves on the locking trigger spring 354 correspond to the locking steel balls 351. A sleeve locking signal switch 81 is provided on the housing 8.

[0098] Before use, there is no medicine in the drug storage device 4. The user needs to inject the medicine into the drug storage cavity 41 using a syringe. At this time, the piston body 31 will move backward as the medicine is injected. The lead screw 32 and lead screw sleeve 341 connected to the piston body 31 need to slide freely backward in the worm gear sleeve 342. When the injection begins, the worm gear sleeve 342 and lead screw sleeve 341 must be locked and cannot slide freely in order for the lead screw 32 to push the piston body 31 forward to inject the medicine.

[0099] When injection begins, the turbine starts rotating, and the locking trigger spring 354 rotates along with the turbine. When the sleeve locking signal switch 81 can no longer block the locking trigger spring 354, the locking trigger spring 354 pushes the locking steel ball 351 into the locking slot 352. The gap between the inside of the locking slot 352 and the lead screw sleeve 341 is V-shaped, and the gap decreases as it goes deeper into the locking slot 352. When the locking steel ball 351 reaches a certain distance inside the locking slot 352 where the gap is smaller than the diameter of the locking steel ball 351, the locking steel ball 351, the locking slot 352, and the lead screw sleeve 341 are mutually locked, and the lead screw sleeve 341 and the worm gear sleeve 342 are mutually locked. This solves the problem that the worm gear sleeve 342 and the lead screw sleeve 341 need to slide freely during filling but are locked together during injection.

[0100] Furthermore, a guide rod 36 is fixedly installed on the piston body 31. The length direction of the guide rod 36 is parallel to the length direction of the lead screw 32. A guide seat 82 is provided on the housing 8. The guide rod 36 passes horizontally through the guide seat 82 and slides with it.

[0101] An injection method for a continuous micro-dose delivery device provided by the present invention includes the following steps:

[0102] Step S1: Add sufficient medicine solution to the medicine storage device 4.

[0103] Step S2: Control device 6 receives externally input injection instructions or injection procedures.

[0104] Step S3: The control device 6 starts the control accumulator release device 1 to release the specified piston stroke, and the accumulator device 2 pushes the piston push rod device 3 to move into the drug storage device 4 to move the specified piston stroke, thus completing the quantitative injection.

[0105] Step S3 includes the following sub-steps:

[0106] Step S3.1: The control device 6 converts the externally input injection command or injection program into a series of corresponding electrical pulse signals and transmits them to the fixed coil.

[0107] Step S3.2: The fixed coil 111 drives the permanent magnet 112 to make corresponding movements, causing the output gear 113 to rotate, and through the gear set 121, it drives the worm gear 33 to rotate. The lead 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, thus locking the lead screw sleeve 341 and the worm gear sleeve 342.

[0108] In step S3.3, the control device 6 obtains the locking signals of both the lead screw sleeve 341 and the worm gear sleeve 342, and releases the piston stroke contained in the externally input injection command through the coil, output gear 113 and gear set 121 to complete the quantitative injection.

[0109] During initial installation, the energy release device 1, energy storage device 2, and piston pusher device 3 are installed in place. Because the three are coupled and static, the piston is positioned at the top of the drug storage cavity 41. The user injects insulin into the drug storage cavity 41 through the injection port using a syringe. The piston body 31 is pushed back by the force, triggering the power switch to connect the circuit. After the injection is completed, the user issues an infusion command via Bluetooth communication through the controller. After receiving the command, the control device 6 sends out a corresponding electrical pulse. The rotating magnetic brake assembly 11 is deflected at an angle under the electrical pulse, and the output gear 113 also rotates at the corresponding angle. The corresponding angle is transmitted through the coupling mechanism, and the locking assembly 35 locks the screw sleeve 341 and the turbine sleeve 342, allowing the energy storage device 2 to push the piston body 31 to make corresponding movements. The squeezed liquid flows out through the tubing and out of the needle tip of the soft needle 56.

[0110] In the description of this application, it should be understood that the terms "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They 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, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0111] Specific embodiments of the present invention have been described above. It should be understood that the present invention is not limited to the specific embodiments described above, and those skilled in the art can make various changes or modifications within the scope of the claims, which do not affect the essence of the present invention. Unless otherwise specified, the embodiments and features described in this application can be arbitrarily combined with each other.

Claims

1. A continuous micro-dose delivery device, characterized in that, It includes a needle device (5), a drug storage device (4), a piston rod device (3), a power storage device (2), a power storage release device (1), and a control device (6); Under the action of the control device (6), the power release device (1) releases the specified piston stroke, the power storage device (2) pushes the piston rod device (3) to move the specified piston stroke into the drug storage device (4), and the drug liquid in the drug storage device (4) is discharged through the needle device (5). The energy storage and release device (1) includes a rotary magnetic brake assembly (11) and a coupling assembly (12). The rotary magnetic brake assembly (11) is electrically connected to the control device (6). The rotary magnetic brake assembly (11) controls the piston stroke of the piston push rod device (3) through the coupling assembly (12). The energy storage device (2) outputs rotational torque or linear thrust to the piston push rod device (3). 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 be positioned. An output gear (113) is fixedly mounted on the permanent magnet (112). The energy storage device (2) includes an elastic element, which is in a compressed state; The coupling assembly (12) includes a gear set (121), the output gear (113) meshes with the transmission start end gear (122) of the gear set (121), and a winding wheel (124) is provided on the transmission end gear (123) of the gear set (121). A pull wire (125) is wound on the winding wheel (124), and the pull wire (125) extends from one end of the elastic element away from the piston push rod device (3) along the extension and retraction direction of the elastic element to the piston push rod device (3) and is connected to the piston push rod device (3).

2. The continuous micro-dose delivery device as described in claim 1, characterized in that, A safety valve (7) is provided on the connecting pipeline between the drug storage device (4) and the needle device (5). 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 connected to the needle device (5). The sealing ring (73) and the diaphragm (72) are arranged sequentially 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) facing away from the sealing ring (73) is connected to the drug storage device (4). The diaphragm (72) is provided with an 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). The inlet hole (721), the flow limiting hole (731) and the flow guide groove (75) are connected in sequence. 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; When the safety valve (7) is in the closed state, the diaphragm (72) seals the outlet (74).

3. The continuous micro-dose delivery device as described in claim 1, characterized in that, 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), and a soft needle (56). The rotating needle seat (52) is rotated and raised within the vertical needle seat (51). The outer wall of the rotating needle seat (52) is provided with a rotating needle seat guide groove (57). The rotating needle seat guide groove (57) extends spirally downward from the upper end of the rotating needle seat (52) to the lower end of the rotating needle seat (52), and then extends spirally upward from the lower end of the rotating needle seat (52) to the upper end of the rotating needle seat (52). The vertical needle seat (51) has a vertical needle seat guide groove (58) vertically arranged on its inner wall. 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. 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) from top to bottom. The hard needle seat (53) is slidably arranged in the rotating needle seat guide groove (57).

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