Automatic syringe with variable plunger force

Abstract

The present invention provides an auto-injector and related methods that optimize administration accuracy, such as reducing residual drug after injection, and prevent drug leakage through or around the cartridge's end stopper. [Solution] Disclosed is a method for administering a drug and an automatic injector 4. The processing unit is configured to control a drive module to push a plunger rod at a plunger rod speed and move it toward a plunger rod position, to determine the plunger rod position, to receive a resistance signal, and to control the drive module to adjust the movement of the plunger rod when the resistance signal indicates resistance to movement of the plunger rod beyond a high resistance threshold, the high resistance threshold being based on the plunger rod position.

Description

Technical Field

[0001] The present disclosure relates to an autoinjector such as an electronic autoinjector, a system comprising an autoinjector and a cartridge, and a method of operating an autoinjector.

Background Art

[0002] Subcutaneous syringes are widely used for delivering fluids to the body. Subcutaneous syringes applicable to manual operation are known. However, autoinjectors such as electronic autoinjectors have been developed and are widely used to assist in the administration of fluids or drugs to the body.

[0003] There is a growing interest in autoinjectors automatically performing as many injection processes as possible to avoid relying on the user performing a particular task correctly.

[0004] However, for the safety of the user, such autoinjectors are continuously desired to prevent adverse use and ensure or facilitate proper administration of the drug, or to prevent or reduce incorrect use or the consequences of incorrect use, such as incorrect dosage or infection.

[0005] Enabling accurate control of the amount of drug to be injected and / or absorbed by the tissue is even more important. Therefore, there is a growing interest in reducing the risk of drug leakage or spillage and further reducing the amount of residual drug in the cartridge after injection.

[0006] The force of the plunger is often limited to avoid backflow of the drug during injection, i.e., to avoid backflow of the drug around the stopper opposite to being discharged through the needle. Other purposes for limiting the force of the plunger include, for example, preventing drug leakage or preventing damage to the cartridge structure.

Summary of the Invention

Problems to be Solved by the Invention

[0007] While known solutions exist, there is a need for auto-injectors and related methods to optimize administration accuracy, such as reducing residual drug after injection, and to prevent drug leakage through or around the cartridge's end stopper. [Means for solving the problem]

[0008] Accordingly, an automatic syringe for administering drugs is disclosed. The automatic syringe comprises a housing, a cartridge receiving section, a drive module, a resistance sensor, and a processing section.

[0009] The cartridge receiving section is configured to receive a cartridge equipped with a first stopper. The drive module is connected to move the plunger rod between the retraction plunger rod position and the push plunger rod position, for example, forward. The plunger rod is configured to move the first stopper, for example, forward.

[0010] The resistance sensor is configured to provide a resistance signal indicating the resistance to the movement of the plunger rod.

[0011] The processing unit is connected to the drive module. The processing unit is connected to the resistance sensor.

[0012] The processing unit is configured to control the drive module to push the plunger rod at the plunger rod speed and move it toward the plunger rod position, for example, forward; to determine the plunger rod position; to receive a resistance signal; and to control the drive module to adjust the movement of the plunger rod if the resistance signal indicates resistance to movement exceeding a high resistance threshold of the plunger rod. The high resistance threshold is based on the plunger rod position.

[0013] The housing may contain one or more of the following: a cartridge receiving section, a drive module, a resistance sensor, and a processing section.

[0014] The system is also disclosed. This system comprises an automatic syringe and a cartridge equipped with a first stopper, the cartridge being configured to be received in a cartridge receiving section.

[0015] A method for controlling an automatic syringe is also disclosed. The method includes the steps of receiving a cartridge equipped with a first stopper, pushing a plunger rod at a plunger rod speed and moving it toward a plunger rod position, determining the plunger rod position, receiving a resistance signal indicating resistance to movement of the plunger rod, and adjusting the movement of the plunger rod if the resistance signal indicates resistance to movement exceeding a high resistance threshold of the plunger rod, the high resistance threshold being based on the plunger rod position.

[0016] The advantage of this disclosure is that it provides a method to optimize administration accuracy by more completely emptying the drug cartridge during injection by applying more force to the stopper and maintaining such increased force for a certain period of time, thereby forcing the stopper to deform / compress and make better contact (fill) with the shoulder region of the internal cartridge, thereby pushing out any residual drug present therein. In addition, the approach of the disclosure also provides improved drug utilization, as less drug is wasted from each cartridge.

[0017] The plunger rod speed can be further optimized, for example, to optimize the injection procedure time, such as the time required to inject the drug and / or the preparation for injection.

[0018] A further benefit of this disclosure is that it enhances patient safety, for example, by reducing the risk of drug misadministration.

[0019] Furthermore, this disclosure offers the advantage of enabling improved accuracy in drug utilization and reducing the amount of unused drug. Therefore, a further advantage of this disclosure is the reduction of the cost of unused drug.

[0020] The high resistance threshold may be based on the plunger rod position. The high resistance threshold may be a first high resistance threshold and / or a second high resistance threshold and / or a third high resistance threshold.

[0021] The processing unit may be configured to determine a high resistance threshold based, for example, the plunger rod position.

[0022] The high resistance threshold may be the first high resistance threshold when the plunger rod position is between the pull-back plunger rod position and the first plunger rod position. Alternatively or additionally, the high resistance threshold may be the second high resistance threshold when the plunger rod position is between the second plunger rod position and the push-in plunger rod position.

[0023] The second high-resistance threshold may be higher than the first high-resistance threshold. If the second high-resistance threshold corresponds to the plunger rod position at the end of drug injection, the high-resistance threshold may be higher for the purpose of effectively emptying the cartridge without the risk of leakage at the stopper or septum at the end of injection, as the contribution of needle flow resistance to the pressure in the cartridge is low.

[0024] The first high resistance threshold may be between 50 and 80 N, for example, 50 N, 55 N, 60 N, 65 N, 70 N, 75 N, or 80 N. In one example, the first high resistance threshold is 55 N.

[0025] The second high resistance threshold may be between 70 and 100 N, for example between 75 and 85 N, or for example between 80 and 90 N, or for example 70 N, 75 N, 80 N, 85 N, or 90 N. In one example, the second high resistance threshold is 80 N.

[0026] The high resistance threshold value may be the third high resistance threshold value when the plunger rod position is between the first plunger rod position and the second plunger rod position. The high resistance threshold value may be the third high resistance threshold value when the plunger rod position is at the third plunger rod position. The third plunger rod position may be between the first plunger rod position and the second plunger rod position.

[0027] The third high resistance threshold value may be higher than the first high resistance threshold value. The third high resistance threshold value may be lower than the second high resistance threshold value. The third high resistance threshold value may be between the first high resistance threshold value and the second high resistance threshold value.

[0028] The high resistance threshold value, for example, the third high resistance threshold value, may increase as the plunger rod position moves from the first plunger rod position to the second plunger rod position.

[0029] The distance between the pushed-in plunger rod position and the first plunger rod position may be between 1 and 3 mm, for example, 2 mm.

[0030] The distance between the pulled-back plunger rod position and the first plunger rod position may be between 0 and 60 mm.

[0031] The distance between the pulled-back plunger rod position and the first plunger rod position may be between 50 and 60 mm, for example, 55 mm, 56 mm, or 57 mm.

[0032] The automatic syringe may be equipped with a code sensor. The code sensor may be configured to read cartridge code functions, such as cartridge code functions on and / or attached to the cartridge. The code sensor may be configured to transmit a code signal indicating a cartridge code function. The code sensor may be configured to read cartridge code functions at multiple locations. The cartridge code sensor may be movable. The cartridge code sensor may comprise multiple sensors, such as multiple transmitters and / or receivers.

[0033] The code sensor may include an optical sensor. The code sensor may include an optical sensor comprising a transmitter and receiver, such as an optical transmitter and an optical receiver. The code sensor may be configured to read cartridge code functions. The code sensor may be configured to read QR codes (registered trademark), barcodes, color codes, and / or any combination thereof.

[0034] The processing unit may be connected to a code sensor. The processing unit may be configured to receive a code signal from the code sensor indicating the cartridge code function. The processing unit may be configured to determine the plunger rod positions, such as the first plunger rod position and / or the second plunger rod position, based on the code signal.

[0035] The resistance sensor may be configured to measure the pressure and / or force applied to the front end of the plunger rod. The front end of the plunger rod may be configured to engage with a first stopper of the cartridge. The resistance sensor may be configured to measure the pressure and / or force between the plunger rod and the stopper. For example, the resistance sensor may include a pressure transducer and / or force transducer at the front end of the plunger rod. The plunger rod may include the resistance sensor.

[0036] Alternatively or additionally, the resistance sensor may be configured to determine the current flowing through the drive module and / or the power consumed by the drive module. For example, the resistance sensor may be configured to measure the electrical resistance, current, and / or voltage of the drive module. The resistance sensor may comprise an electrical resistance sensor, a current sensor, and / or a voltage sensor. The resistance signal may be based on the power consumed by the drive module, for example, the determined power consumed by the drive module. The resistance signal may be based on the current flowing through the drive module, for example, the measured current flowing through the drive module. The drive module may comprise a resistance sensor.

[0037] Instead of applying a dedicated force sensor, a practical way to monitor the force or resistance of an equivalent plunger, due to the cost and structural complexity of applying such a sensor between, for example, a plunger and a cartridge stopper, is to monitor the current flowing through the drive module, for example, the motor of the drive module. In the case of electromechanical systems, this correlates well with the output. The force acting on an inductor in a magnetic field can be expressed as F = B * I * l, where B is the strength of the magnetic field, I is the inductor current, and l is the length of the inductor in the magnetic field.

[0038] The automatic syringe may be an electronic automatic syringe. The automatic syringe may be equipped with a battery. The housing may accommodate the battery. The battery may be a rechargeable battery. For example, the battery may be a lithium-ion battery, a NiCd battery, or a NiMH battery. The battery may be configured to be charged by connecting a charger.

[0039] The drive module may comprise one or more electrical elements. The drive module may be configured to receive power from a battery. The drive module may be electrically connected to a battery to receive power. The drive module may comprise a motor such as an electromechanical motor, including a DC motor such as a brushed or brushless DC motor. The drive module may comprise a solenoid motor. The drive module may comprise a shape memory metal engine. The drive module may comprise an array of springs configured to actuate a plunger rod. The drive module may contain pressurized gas configured to actuate a plunger rod. A cartridge, for example, a cartridge compartment of a cartridge, may contain a drug. The movement of the first stopper may discharge the drug from the cartridge, for example, from the cartridge compartment through the cartridge outlet, and / or discharge air from the cartridge, for example, from the cartridge compartment through the cartridge outlet.

[0040] The plunger rod position, including the plunger rod position at a specific moment and the current plunger rod position, may be determined, for example, by a processing unit. The plunger rod position may also be determined based on detection from a sensor, such as a plunger rod position sensor.

[0041] The automatic syringe may be equipped with a plunger rod position sensor. The plunger rod position sensor may be configured to detect the position of the plunger rod and / or the position of the first stopper. The drive module may be equipped with a plunger rod position sensor.

[0042] The automatic syringe may be equipped with a tachometer. The plunger rod position sensor may be equipped with a tachometer. The plunger rod position sensor may also be a tachometer. The tachometer may be configured to count the rotation of the drive module, for example, the motor of the drive module, such as the rotation of the drive module from a point where the position of the plunger rod is known, such as the retracted plunger rod position, for example, the position when the plunger rod is fully retracted. The rotations of the drive module may be used to determine the plunger rod position, i.e., the position of the plunger rod at a particular moment.

[0043] The tachometer may be configured to provide a tachometer signal indicating the rotational speed of the drive module. The processing unit may be connected to the tachometer. The processing unit may be configured to receive the tachometer signal. The processing unit may be configured to determine the current plunger rod position based on the tachometer signal.

[0044] The processing unit may be connected to the plunger rod position sensor. The processing unit may receive a first plunger rod position sensor signal from the plunger rod position sensor, such as a tachometer signal indicating the rotational speed of the drive module. The processing unit may determine the position of the plunger rod based on the first plunger rod position sensor signal, for example, the tachometer signal. The processing unit may receive a second plunger rod position sensor signal from the plunger rod position sensor, for example, a second plunger rod position signal indicating a plunger rod in a known position, such as a fully retracted plunger rod position. The processing unit may be configured to determine the position of the plunger rod based on the first plunger rod position sensor signal, for example, the tachometer signal, and the second plunger rod position sensor signal. The processing unit may be configured to determine the plunger rod position based on the tachometer signal and the retracted plunger rod position. For example, the processing unit may be configured to determine the plunger rod position based on the rotational speed of the drive module since the plunger rod was in the retracted plunger rod position.

[0045] The process of adjusting the movement of the plunger rod may include reducing the plunger rod speed.

[0046] The process of adjusting the movement of the plunger rod may include stopping the movement of the plunger rod.

[0047] The step of adjusting the movement of the plunger rod may include preventing the plunger rod from moving to the retraction plunger rod position during the residence time. Alternatively or additionally, the step of adjusting the movement of the plunger rod may include maintaining the position of the plunger rod during the residence time. By preventing retraction or movement to the retraction plunger rod position, backflow of the drug due to a decrease in pressure within the cartridge can be prevented.

[0048] The process of adjusting the movement of the plunger rod may include retracting the plunger rod and moving it to the plunger rod position. For example, the plunger rod may be retracted and moved to the plunger rod position after a dwell time.

[0049] The process of adjusting the movement of the plunger rod may include gradually reducing the plunger rod speed, stopping the plunger rod speed, preventing the plunger rod from moving to the retracted plunger rod position, and moving the plunger rod to the retracted plunger rod position after a dwell time.

[0050] After adjusting the movement of the plunger rod, the movement of the plunger rod may be readjusted. The processing unit may be configured to control the drive module to readjust the movement of the plunger rod after adjusting the movement of the plunger rod. For example, if the resistance to the movement of the plunger rod falls below a high resistance threshold, the movement of the plunger rod may be readjusted after adjusting the movement of the plunger rod. If the resistance signal indicates that the resistance to the movement of the plunger rod falls below a high resistance threshold, the processing unit may be configured to control the drive module to readjust the movement of the plunger rod after adjusting the movement of the plunger rod. The step of readjusting the movement of the plunger rod includes increasing the plunger rod speed. The plunger rod speed may be changed. For example, the plunger rod speed may be based on the plunger rod position. The plunger rod speed may be the first plunger rod speed when the plunger rod position is between the pull-back plunger rod position and the fourth plunger rod position. The plunger rod speed may be the second plunger rod speed when the plunger rod position is between the fifth plunger rod position and the push-in plunger rod position. The second plunger rod speed may be slower than the first plunger rod speed. Alternatively, the second plunger rod speed may be faster than the first plunger rod speed. The processing unit may be configured to determine the plunger rod speed, for example, based on the plunger rod position.

[0051] The position of the fourth plunger rod may be the same as the position of the first plunger rod. The position of the fifth plunger rod may be the same as the position of the second plunger rod. The position of the first plunger rod and the position of the second plunger rod may be the same as the position of the second plunger rod. The position of the fourth plunger rod and the position of the fifth plunger rod may be the same as the position of the second plunger rod.

[0052] A cartridge configured to be received by an automatic syringe, for example by the cartridge receiving section of the automatic syringe, may have a cartridge outlet at a first cartridge end. The cartridge may have a cartridge rear at a second cartridge end, for example, on the opposite side of the cartridge outlet. The cartridge rear may have a cartridge rear end opening. The cartridge rear end opening allows a plunger rod, for example, the plunger rod of the automatic syringe, to access a first stopper.

[0053] The cartridge compartment may contain a drug. The cartridge outlet may be configured to communicate fluidly with the cartridge compartment, for example, at the first cartridge end. The cartridge may be configured to discharge the drug through the cartridge outlet. The cartridge outlet may be connected to a needle, such as a subcutaneous injection needle, to provide the drug to be discharged through the needle.

[0054] The first stopper of the cartridge may be movable within the cartridge compartment. The cartridge may have a second stopper that is movable within the cartridge compartment. The second stopper may be located between the first stopper and the cartridge outlet. The cartridge may have a third stopper that is movable within the cartridge compartment. The third stopper may be located between the second stopper and the cartridge outlet. The first stopper, the second stopper, and / or the third stopper may be movable within the cartridge compartment toward the cartridge outlet, for example toward the first cartridge end, toward the first stopper. For example, the drug may be discharged through the cartridge outlet when the first stopper, the second stopper, and / or the third stopper move, for example toward the first stopper and / or toward the cartridge outlet.

[0055] The cartridge may be a dual-chamber cartridge. The cartridge compartment may have a first cartridge subcompartment and a second cartridge subcompartment. The first cartridge subcompartment may be located between a first stopper and a second stopper. The second cartridge subcompartment may be located between a second stopper and a cartridge outlet and / or a third stopper.

[0056] The first cartridge subcompartment may contain the first drug component of the drug. The second cartridge subcompartment may contain the second drug component of the drug. The first drug component and / or the second drug component may each be a powder composition, a fluid, a liquid, a gel, a gas, and / or any combination thereof. The first drug component and / or the second drug component may be a solute, such as a powder composition. The first drug component and / or the second drug component may be a solvent, such as a fluid composition including a liquid composition. The second drug component may be a powder composition, and the first drug component may be a fluid composition, such as water, ethanol, saline solution, a buffer solution, or a storage solution. The second drug component may be a solute. The first drug component may be a solvent. The drug is envisioned to be any drug that can be injected subcutaneously via a needle after drug reconstitution. The drug may be growth hormone. The drug may be human growth hormone. The drug may be, for example, a long-acting human growth hormone depot formulation. The second drug component may be a powder composition of human growth hormone. The cartridge may have a bypass section, for example, when a second stopper is placed in the bypass section, a fluid communication is established between the first cartridge subcompartment and the second cartridge subcompartment. The cartridge may have multiple bypass sections, for example, when a stopper separating adjacent cartridge subcompartments is placed in each bypass section, a fluid communication is established between adjacent cartridge subcompartments. The disclosed auto-injector may be a reusable auto-injector. Reusable auto-injectors are particularly useful when the cartridge has multiple subcompartments. For example, auto-injectors for multi-compartment or multi-chamber cartridges may be more advanced, and therefore it may be beneficial to allow the auto-injector to be used multiple times. For example, the auto-injector may provide an automated process for mixing drug components, such as mixing the drug components originally contained in different subcompartments of the cartridge.

[0057] Any embodiment or element described in relation to any one aspect is intended to be used in conjunction with any other aspect or embodiment, with necessary modifications.

[0058] The above and other features and advantages of the present invention will be readily apparent to those skilled in the art by describing exemplary embodiments thereof in detail below with reference to the accompanying drawings. [Brief explanation of the drawing]

[0059] [Figure 1] Figure 1 shows a schematic representation of an exemplary automatic syringe. [Figure 2] Figure 2 schematically shows an exemplary automatic syringe with a cartridge. [Figure 3] Figure 3 shows a schematic representation of an exemplary cartridge. [Figure 4] Figure 4 schematically shows an exemplary automatic syringe with a cartridge. [Figure 5] Figure 5 shows a block diagram of an exemplary automatic syringe. [Figure 6] Figure 6 shows a schematic representation of an exemplary automatic syringe. [Figure 7] Figure 7 shows an exemplary graph of resistance threshold versus plunger position. [Figure 8] Figure 8 shows an exemplary graph of the resistor vs. plunger position. [Figure 9]Figure 9 shows an exemplary graph of plunger velocity versus plunger position. [Figure 10] Figure 10 shows a flowchart of an exemplary method. [Figure 11] Figure 11 shows a flowchart of an exemplary method. [Figure 12] Figure 12 shows a flowchart of an exemplary method. [Figure 13] Figure 13 shows a flowchart of an exemplary method. [Figure 14] Figure 14 shows a flowchart of an exemplary method. [Modes for carrying out the invention]

[0060] Various embodiments are described below with reference to the drawings. Throughout this description, similar reference numerals refer to similar elements. Therefore, similar elements may not be described in detail with respect to each figure. It should also be noted that the figures are intended solely to facilitate the description of the embodiments. They are not intended to be an exhaustive description of the claimed invention or a limitation on the scope of the claimed invention. Furthermore, the illustrated embodiments do not necessarily have all the aspects or advantages shown. Aspects or advantages described in relation to a particular embodiment are not necessarily limited to that embodiment and may be implemented in other embodiments even if they are not illustrated or explicitly described in that way.

[0061] Throughout the text, the same reference number is used for identical or corresponding parts.

[0062] Figure 1 shows an exemplary auto-injector 4. The auto-injector 4 may be configured to administer a drug. The auto-injector 4 may also be an electronic auto-injector. The automatic syringe 4 includes a housing 6. The automatic syringe 4 includes a cartridge receiving section 300. The cartridge receiving section is configured to receive a cartridge and / or a cartridge assembly containing a cartridge. The cartridge may contain a drug. The cartridge receiving section 300 has a cartridge receiving opening 301. The cartridge receiving section 300 is configured to receive a cartridge and / or cartridge assembly through the cartridge receiving opening 301 in the cartridge receiving direction 304 along the longitudinal axis L.

[0063] The automatic syringe 4 may include a user interface 1100, as shown in the figure. The automatic syringe 4 includes a trigger member such as a contact member 1102. The contact member 1102 may be configured to be pressed against the injection site. When pressed against the injection site, the contact member 1102 may be movable relative to the housing in the cartridge receiving direction 304. The contact member 1102 may be part of the user interface 1100.

[0064] The user interface 1100 may include a first input member 1108, such as a button, as shown in the figure. The first input member 1108 may provide user input from the user. For example, the first input member 1108 may be used to receive a push from the user to proceed to the next step. The user interface 1100 may include a first output component 1110, such as a plurality of LEDs, as shown in the figure. The first output component 1110 may provide user output to the user. The user interface 1100 may also include a second output component (not shown), such as a speaker. The second output component may be configured to provide audible output to the user. For example, the first output component 1110 and / or the second output component may be used to show the user the steps of a procedure and / or to show error messages.

[0065] Figure 2 shows an exemplary system 2. System 2 comprises an automatic syringe 4 described in relation to Figure 1 and an exemplary cartridge 700 that is received in a cartridge receiving section 300. The cartridge 700 includes a first stopper (not shown). The cartridge 700 is shown together with a needle cover 908. As shown, the needle cover 908 can be removed from the cartridge 700 by extending it from the contact member 1102.

[0066] Figure 3 schematically shows an exemplary cartridge 700, such as a cartridge 700 configured to be received in the cartridge receiving section of an autoinjector, like the autoinjector described in relation to the previous figure.

[0067] The cartridge 700 includes a cartridge compartment 702, which may be configured to hold a drug. The cartridge 700 has a first end 718 and a second end 720. The cartridge 700 has a cartridge outlet 714 at the first cartridge end 718. The cartridge may be configured to discharge the drug through the cartridge outlet 714.

[0068] The cartridge includes a first stopper 708 that is movable within the cartridge compartment 702, for example toward a first cartridge end 718, for example in a first stopper direction 722. For example, the drug may be discharged through the cartridge outlet 714 when the first stopper 708 moves in the first stopper direction 722. The cartridge 700 has a cartridge rear 716 at a second cartridge end 720. The cartridge rear 716 has a cartridge rear end opening to allow the plunger rod to access the first stopper 708.

[0069] As shown in the figure, the cartridge 700 may be a dual-chamber cartridge. Accordingly, the cartridge 700 includes a second stopper 710 that is movable within the cartridge compartment 702, for example toward the first cartridge end 718, for example in the first stopper direction 722. The cartridge compartment 702 comprises a first cartridge subcompartment 704 and a second cartridge subcompartment 706. The first cartridge subcompartment 704 is located between the first stopper 708 and the second stopper 710. The first cartridge subcompartment 704 may contain a liquid such as sterile water or buffer solution. The second cartridge subcompartment 706 is located between the second stopper 710 and the cartridge outlet 714. The second cartridge subcompartment 706 may contain a dry agent such as a drug dried by freeze-drying. The cartridge 700 includes a bypass section 712 for fluid communication between the first cartridge subcompartment 704 and the second cartridge subcompartment 706. The bypass section 712 provides fluid communication between the first cartridge subcompartment 704 and the second cartridge subcompartment 706 when the second stopper 710 is positioned in the bypass section 712.

[0070] Figure 4 shows an exemplary system 2. System 2 comprises an auto-injector 4, as described, for example, in relation to Figure 1, and an exemplary cartridge assembly 600. The cartridge assembly 600 comprises a cartridge 700 having a cartridge compartment 702, a needle assembly 900, and an optional cartridge code function 1000. In the illustrated example, the cartridge assembly 600 is received by the auto-injector 4.

[0071] The cartridge assembly 600 includes a cartridge holder 800. The cartridge holder is configured to hold the cartridge 700 in the cartridge receiving section 300 of the auto-injector 4. The cartridge holder 800 includes a cartridge holding member 808. The cartridge holding member engages with the cartridge receiving section 300 to receive the cartridge 700 and the cartridge assembly 600 into the cartridge receiving section.

[0072] The needle assembly 900 comprises a needle 902 and a needle hub 904. The needle assembly 900 is attached to the cartridge 700 by the needle hub 904 having a cartridge holder connector 906, such as a threaded connector, which engages with a needle assembly connector 812 of the cartridge holder 800, for example. The needle 902 extends through a cartridge outlet 714 of the cartridge 700. The cartridge outlet 714 may be blocked by an elastic seal through which the needle 902 passes when the needle assembly 900 is attached to the cartridge 700.

[0073] The automatic syringe 4 includes an optional code sensor 24 configured to read the cartridge code function 1000. When the cartridge assembly 600 is inserted as shown in the figure, the cartridge code function 1000 is aligned with the code sensor 24.

[0074] The automatic syringe 4 includes a plunger rod 400. The plunger rod 400 is configured to advance the first stopper of the cartridge 700. The plunger rod 400 includes an outer plunger rod 404 having an inner thread and an inner plunger rod 402 having an outer thread. The thread of the inner plunger rod 402 engages with the thread of the outer plunger rod 404. The outer plunger rod 404 is configured not to rotate relative to the housing of the automatic syringe. Movement of the plunger rod 400 includes rotation of the inner plunger rod 402. The rotation of the inner plunger rod 402 results in translational motion of the outer plunger rod 404 because the rotation of the outer plunger rod 404 is restricted. When the outer plunger rod 404 translates in the first stopper direction 722, it contacts the first stopper of the cartridge 700 and is configured to move the first stopper in the first stopper direction 722.

[0075] The drive module 500 is connected to operate the plunger rod 400. The drive module 500 is electrically connected to a battery to receive power. The drive module 500 includes a motor 502, such as a DC motor or other electromechanical motor. The drive module 500 includes a transmission 504 for connecting the motor 502 to the inner plunger rod 402 of the plunger rod 400.

[0076] The example shown includes a motor 502, which may be an electromechanical motor, but it will be easy to see that an automatic syringe 4 can be realized with an alternative drive module, such as a solenoid motor, a shape memory metal engine, an array of springs configured to actuate a plunger rod 400, and / or pressurized gas.

[0077] The automatic syringe 4 includes a plunger rod position sensor 26. The plunger rod position sensor 26 is configured to detect the position of the plunger rod 400. In the illustrated example, the plunger rod position sensor 26 includes a tachometer configured to count / detect the rotation of the motor 502. Thus, the position of the plunger rod 400 can be determined. Based on the detection of the position of the plunger rod 400, the plunger rod position sensor 26 can detect the discharge of drug and / or air from the cartridge compartment. The position of the plunger rod 400 indicates the position of the first stopper 708 of the cartridge 700.

[0078] Figure 5 shows a block diagram of an exemplary automatic syringe 4. The automatic syringe 4 comprises a plurality of sensors 22, 24, 26, 28, 30, 32, 34, a processing unit 20, a drive module 500, and a user interface 1100. Sensors 22, 24, 26, 28, 30, 32, and 34 are connected to the processing unit 20. The user interface 1100 is connected to the processing unit 20. The processing unit is connected to the drive module 500.

[0079] The processing unit 20 receives signals from sensors 22, 24, 26, 28, 30, 32, 34 and the user interface 1100. The processing unit 20 is configured to control the drive module 500. The processing unit 20 may control the drive module 500 based on one or more signals received from sensors 22, 24, 26, 28, 30, 32, 34 and the user interface 1100. The automatic syringe 4 includes a direction sensor 22. The direction sensor 22 is configured to provide a direction signal indicating the orientation of the cartridge received in the automatic syringe 4. For example, the direction sensor 22 may be configured to detect the orientation of the automatic syringe 4. The orientation of the cartridge may be determined based on the orientation of the automatic syringe 4. The direction sensor 22 may be configured to detect the direction of gravity. For example, the direction sensor 22 may include an accelerometer.

[0080] The processing unit 20 is connected to the orientation sensor 22. The processing unit 20 is configured to receive an orientation signal. The processing unit 20 may determine the orientation of the cartridge based on the orientation signal. The processing unit 20 may control the drive module 500 based on the orientation signal. For example, the processing unit 20 may be configured to control the drive module 500 to move the plunger rod based on the orientation signal. For example, the processing unit 20 may be configured to push the plunger rod in and move it toward the plunger rod position by controlling the drive module 500 only when the cartridge outlet is facing upward. Alternatively or additionally, the processing unit 20 may provide a user output via the user interface 1100 based on the orientation signal.

[0081] The automatic syringe 4 includes a code sensor 24. The code sensor 24 is configured to read cartridge code functions. The code sensor 24 is configured to provide a code signal indicating a cartridge code function. For example, the code sensor may be configured to read / detect color codes.

[0082] The processing unit 20 is connected to the code sensor 24. The processing unit 20 is configured to receive code signals. The processing unit 20 may determine the cartridge code function of the cartridge assembly based on the code signals. The processing unit 20 may be configured to determine the first plunger rod position and / or the second plunger rod position based on the code signals. The processing unit 20 may control the drive module 500 based on the code signals. For example, the processing unit 20 may be configured to push the plunger rod toward the plunger rod position by controlling the drive module 500 based on the code signals. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the code signals.

[0083] The automatic syringe 4 is equipped with a plunger rod position sensor 26. The plunger rod position sensor 26 is configured to detect the position of the plunger rod of the automatic syringe 4 and to provide a plunger rod position sensor signal indicating the position of the plunger rod. The plunger rod position sensor 26 may also include a tachometer connected to the drive module 500.

[0084] The processing unit 20 is connected to the plunger rod position sensor 26. The processing unit 20 is configured to receive the plunger rod position sensor signal. The processing unit 20 may determine the position of the plunger rod based on the plunger rod position sensor signal. The processing unit 20 may control the drive module 500 based on the plunger rod position sensor signal. For example, the processing unit 20 may be configured to start, stop, or continue the movement of the plunger rod by controlling the drive module 500 based on the plunger rod position sensor signal. For example, the processing unit 20 may be configured to determine the plunger rod position based on the plunger rod position sensor signal. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the plunger rod position sensor signal.

[0085] The processing unit 20 is connected to the cartridge sensor 28. The processing unit 20 is configured to receive the cartridge sensor signal. The processing unit 20 may control the drive module 500 based on the cartridge sensor signal. For example, the processing unit 20 may be configured to control the drive module 500 to start moving the plunger rod only when the cartridge assembly is accepted and / or only when the cartridge assembly is accepted. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the cartridge sensor signal.

[0086] The code sensor 24 and the cartridge sensor 28 may be the same sensor; for example, the code sensor 24 may be configured to detect the acceptance of a cartridge assembly and subsequently read the cartridge code function.

[0087] The automatic syringe 4 includes a needle sensor 30. The needle sensor 30 is configured to detect the needle of the cartridge assembly and / or the needle assembly and / or the needle cover of the needle assembly when the cartridge assembly is accepted into the automatic syringe 4. The needle sensor 30 provides a needle signal indicating the presence of the needle of the cartridge assembly and / or the needle assembly and / or the needle cover of the needle assembly.

[0088] The processing unit 20 is connected to the needle sensor 30. The processing unit 20 is configured to receive the needle signal. The processing unit 20 may control the drive module 500 based on the needle signal. For example, the processing unit 20 may be configured to control the drive module 500 to start moving the plunger rod only if the needle is present and / or if the needle cover is absent, e.g., removed. Detection of the needle cover may indicate the presence of the needle. The processing unit 20 may be configured to control and start the drive module 500 only if the needle cover is detected and subsequently removed. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the needle signal.

[0089] The automatic syringe 4 is equipped with a temperature sensor 32. The temperature sensor 32 is configured to detect temperatures such as the temperature of the automatic syringe and / or the cartridge and / or the drug. The temperature sensor 32 is configured to provide a temperature signal indicating the temperature.

[0090] The processing unit 20 is connected to the temperature sensor 32. The processing unit 20 is configured to receive a temperature signal. The processing unit 20 may be configured to determine a temperature, such as the temperature of the automatic syringe and / or cartridge and / or drug, based on the temperature signal. The processing unit 20 may control the drive module 500 based on the temperature signal. For example, the processing unit 20 may be configured to push the plunger rod in and move it toward the plunger rod position by controlling the drive module 500 based on the temperature signal. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the temperature signal.

[0091] The automatic syringe 4 includes a resistance sensor 34. The resistance sensor 34 is configured to detect resistance to the movement of the plunger rod of the automatic syringe 4. The resistance sensor 34 may be configured to detect resistance to the movement of the plunger rod based on measurements from the drive module 500. For example, the resistance sensor 34 may be configured to detect the motor current of the drive module 500. For example, the resistance sensor 34 may be configured to determine the current flowing through the drive module. Alternatively or additionally, the resistance sensor 34 may be configured to measure the pressure and / or force applied to the front end of the plunger rod. The resistance sensor 34 is configured to provide a resistance signal indicating resistance to the movement of the plunger rod.

[0092] The processing unit 20 is connected to the resistance sensor 34. The processing unit 20 is configured to receive a resistance signal. The processing unit 20 may be configured to determine the resistance to the movement of the plunger rod based on the resistance signal. The processing unit 20 may control the drive module 500 based on the resistance signal. For example, the processing unit 20 may be configured to adjust the movement of the plunger rod by controlling the drive module 500 based on the resistance signal. For example, the processing unit 20 may be configured to start, stop, or continue the movement of the plunger rod by controlling the drive module 500 based on the resistance signal.

[0093] The movement of the plunger rod results in a plunger rod speed. The processing unit 20 may be configured to determine the plunger rod speed. The processing unit 20 may be configured to control the drive module 500 to adjust, for example, the movement of the plunger rod when the resistance signal indicates resistance to movement of the plunger rod beyond a high resistance threshold. The processing unit 20 may further be configured to control the drive module 500 to adjust, for example, readjust the movement of the plunger rod, and the adjustment of the movement of the plunger rod may include increasing or decreasing the plunger rod speed. Alternatively or additionally, the processing unit 20 may provide a user output via the user interface 1100 based on the resistance signal. The high resistance threshold may be based on the plunger rod position. The processing unit 20 may be configured to determine the high resistance threshold based on, for example, the plunger rod position. The processing unit 20 may be configured to determine the high resistance threshold based on, for example, the plunger rod position sensor signal received from the plunger rod position sensor 26.

[0094] An automatic syringe 4 equipped with all of the above sensors is shown. However, alternatively, the automatic syringe may be equipped with only one or any combination of the above sensors.

[0095] The automatic syringe includes a user interface 1100. The user interface 1100 may include one or more input members, for example, a first input member, for receiving user input. The user interface is configured to provide user input signals indicating the received user input.

[0096] The processing unit 20 is connected to the user interface 1100. The processing unit 20 is configured to receive user input signals. The processing unit 20 may control the drive module 500 based on the user input signals. For example, the processing unit 20 may be configured to push the plunger rod in and move it toward the plunger rod position by controlling the drive module 500 based on the user input signals.

[0097] The automatic syringe comprises a housing 6 that accommodates sensors 22, 24, 26, 28, 30, 32, 34, a processing unit 20, a user interface 1100, and a drive module 500.

[0098] Figure 6 schematically shows a system 2 comprising an exemplary auto-syringe 4 into which a cartridge assembly comprising a cartridge 700 and a needle assembly 900 is inserted. The auto-syringe 4 as shown in Figure 6 illustrates various methods for implementing sensing of the plunger rod position and the resistance to movement of the plunger rod.

[0099] The plunger rod comprises an outer plunger rod 404 having an inner thread and an inner plunger rod 402 having an outer thread. The thread of the inner plunger rod 402 engages with the thread of the outer plunger rod 404. The outer plunger rod 404 is configured not to rotate relative to the housing 6 of the automatic syringe 4. Rotation of the inner plunger rod 402 results in translational motion of the outer plunger rod 404 because the rotation of the outer plunger rod 404 is restricted. When the outer plunger rod 404 translates in the first stopper direction 722, it contacts the first stopper 708 of the cartridge 700 and is configured to move the first stopper in the first stopper direction 722. The front end 410 of the plunger rod is configured to contact the first stopper 708.

[0100] The motor 502 is connected to drive the plunger rod via the transmission 504. The motor 502 rotates the first part of the transmission 504, which in turn rotates the second part of the transmission 504, and the inner plunger rod 402 connected to it rotates.

[0101] The motor 502 is controlled by the processing unit 20. The automatic syringe 4, including the motor 502 and / or the processing unit 20, is powered by a battery 10, such as a rechargeable battery.

[0102] The positions of the plunger rods, such as the position of the outer plunger rod 404 and / or the position of the plunger rod front end 410, may be determined by one or more position sensors 26a, 26b, 26c. For example, as shown, the plunger rod position may be determined by a position sensor 26a configured to sense the position through a linear sensor connected to the plunger rod, for example, the outer plunger rod 404. Alternatively or additionally, and as shown, the plunger rod position may be determined by a position sensor 26b, such as a tachometer, configured to count / detect the rotation of the motor 502. Alternatively or additionally, and as shown, the plunger rod position may be determined by a position sensor 26c, such as a tachometer, configured to count / detect the rotation of the transmission 504 and / or a portion of the transmission 504.

[0103] The resistance to the movement of the plunger rod may be determined by one or more resistance sensors 34a, 34b, 34c, 34d. For example, as shown in the figure, the resistance to the movement of the plunger rod may be determined by a resistance sensor 34a, such as a force sensor located in front of the cartridge 700, and when the plunger rod advances the first stopper 708, the cartridge pushes against the sensor 34a. Alternatively or additionally, as also shown in the figure, the resistance to the movement of the plunger rod may be determined by a resistance sensor 34b, such as a force sensor located at the front end 410 of the plunger rod. Alternatively or additionally, as also shown in the figure, the resistance to the movement of the plunger rod may be determined by a resistance sensor 34c, such as a force sensor, located to sense the reaction force from the plunger rod on the first stopper 708, for example, the sensor 34c may be located behind the inner plunger rod 402. Alternatively or additionally, as also shown, the resistance to the movement of the plunger rod may be determined by a resistance sensor 34d configured to measure / detect the amount of current and / or power drawn by the motor 502.

[0104] Figure 7a shows a resistance graph 1200 that indicates a high resistance threshold that depends on the stopper position / plunger rod position, such as the high resistance threshold and plunger rod position, as described in relation to the previous figure, and / or the plunger rod position, as described in relation to the previous figure. The plunger rod 400 is configured to move the first stopper 708, and therefore the position of the first stopper 708 is determined by the position of the plunger rod 400. Thus, the position of the first stopper 708 may correspond to the position of the plunger rod 400. The plunger rod position may specify the part of the plunger rod whose front end is in contact with, for example, the first stopper 708.

[0105] The resistance graph 1200 has a first axis 1200X showing the stopper position / plunger rod position and a second axis 1200Y showing the resistance. The solid and dashed lines show different examples of how the high resistance threshold changes depending on the stopper position / plunger rod position.

[0106] Figures 7(b) to 7(f) show the cartridge 700 with the plunger rod 400 and the first stopper 708 in corresponding exemplary plunger rod positions as described below. Figure 7(b) shows the plunger rod 400 in the retraction plunger rod position 1228. Figure 7(c) shows the plunger rod 400 in a position between the retraction plunger rod position 1228 and the first plunger rod position 1220. The first stopper 708 has moved accordingly. Figure 7(d) shows the plunger rod 400 in the first plunger rod position 1220. The first stopper 708 has moved accordingly. Figure 7(e) shows the plunger rod 400 in the second plunger rod position 1222. The first stopper 708 has moved accordingly. Figure 7(f) shows the plunger rod 400 in a position between the second plunger rod position 1222 and the push plunger rod position 1229. The first stopper 708 moves accordingly. The plunger rod position shown in Figure 7(f) may also be the push plunger rod position 1229.

[0107] As shown in the graph of Figure 7a, the high resistance threshold may be the first high resistance threshold 1201 when the plunger rod position is between the pull-back plunger rod position 1228 and the first plunger rod position 1220. The high resistance threshold may be the second high resistance threshold 1202 when the plunger rod position is between the second plunger rod position 1222 and the push-in plunger rod position 1229.

[0108] The second high resistance threshold 1202 may be higher than the first high resistance threshold 1201. For example, the first high resistance threshold 1201 may be between 50 and 80N, for example 50N, 55N, 60N, 65N, 70N, 75N, or 80N. For example, the second high resistance threshold 1202 may be between 70 and 100N, for example between 75 and 85N, or for example between 80 and 90N, or for example 70N, 75N, 80N, 85N, or 90N.

[0109] As shown by the solid line, the high resistance threshold may be a second high resistance threshold 1202 when the plunger rod position is between the first plunger rod position 1220 and the push plunger rod position 1229. Alternatively or additionally, the high resistance threshold may be a third high resistance threshold 1204 when the plunger rod position is between the first plunger rod position 1220 and the second plunger rod position 1222, for example, when the plunger rod position is at the third plunger rod position 1223. The third high resistance threshold 1204 may be higher than the first high resistance threshold 1201. The third high resistance threshold 1204 may be lower than the second high resistance threshold 1202.

[0110] The high resistance threshold may increase as a function of the plunger rod position. For example, as shown in the figure, the high resistance threshold may increase as the plunger rod moves from the first plunger rod position 1220 to the second plunger rod position 1222. The solid and dashed lines illustrate an exemplary increase in the high resistance threshold as the plunger rod moves from the first plunger rod position 1220 to the second plunger rod position 1222. The first slope 1206 shows a stepwise increase. The second slope 1208 shows a nonlinear increase. The third slope 1210 shows a linear increase.

[0111] Figure 8 shows an exemplary trace T of the resistance R to the movement of the plunger rod, depending on the position of the plunger rod P. The plunger rod moves from the retracted position 1228 to the pushed-in position 1229. At the start of the movement, the resistance to the movement of the plunger rod is a constant value Ex1, for example, the plunger rod has not yet pressed the stopper. Subsequently, the front end of the plunger rod contacts the first stopper of the cartridge, and the resistance to the movement of the plunger rod increases to Ex2. The increase in resistance is caused by the resistance to the movement of the first stopper, such as friction. As shown in the figure, the resistance may decrease slightly after the first stopper has started to move. As the plunger rod approaches the pushed-in plunger rod position 1229, the resistance increases again to Ex3, for example, due to the first stopper approaching the end of the cartridge.

[0112] Trace T is an example of resistance to plunger rod movement when the accepted cartridge is new and / or unused and / or a normal cartridge. Other situations in which the accepted cartridge is obviously defective are illustrated by additional exemplary trace T1.

[0113] Trace T1 indicates an exemplary situation in which, for example, the resistance to movement increases beyond a first high resistance threshold 1201 before the plunger rod position passes the first plunger rod position 1220. For example, such a situation may indicate that the movement of the first stopper is blocked, for example, that the cartridge is defective. In such a situation, the plunger rod is pulled back to the retracted position and an error message is provided through the user interface.

[0114] At certain plunger rod positions, such as the first plunger rod position 1220, the high resistance threshold may be changed, for example, to allow for higher resistance before stopping the movement of the plunger rod. As shown in the figure, at the end of the forward movement of the plunger rod, the resistance R increases to a resistance that exceeds the first high resistance threshold 1201, for example at the second plunger rod position 1222. However, since the high resistance threshold at the second plunger rod position is the second high resistance threshold 1202, the movement of the plunger rod continues. Finally, as shown in the figure, the resistance to movement reaches the second high resistance threshold 1202, for example between the second plunger rod position and the pushed plunger rod position 1229, and the movement of the plunger rod stops. Thresholds such as the first high-resistance threshold 1201 and / or the second high-resistance threshold 1202 may be determined individually for each accepted cartridge. For example, the processing unit may be configured to determine one or more thresholds based on the cartridge code function of the accepted cartridge and / or cartridge assembly.

[0115] Figure 9a shows a resistance graph 1300 that indicates the plunger rod speed, plunger rod position, and / or the plunger rod speed that depends on the stopper position associated with the plunger rod position, as described in relation to the previous figure. The plunger rod 400 is configured to move the first stopper 708, and therefore the position of the first stopper is determined by the position of the plunger rod 400. Thus, the position of the first stopper may correspond to the position of the plunger rod 400. The plunger rod position may specify the part of the plunger rod whose front end is in contact with, for example, the first stopper 708.

[0116] The velocity graph 1300 has a first axis 1300X that shows the stopper position / plunger rod position and a second axis 1300Y that shows the velocity, such as the plunger rod velocity. The solid and dashed lines show different examples of how the plunger rod velocity changes depending on the stopper position / plunger rod position.

[0117] Figures 9(b) to 9(e) show the cartridge 700 with the plunger rod 400 and the first stopper 708 in corresponding exemplary plunger rod positions as described below. Figure 9(b) shows the plunger rod 400 in a position between the retraction plunger rod position 1228 and the fourth plunger rod position 1224. Figure 9(c) shows the plunger rod 400 in the fourth plunger rod position 1224. Accordingly, the first stopper 708 has moved to the fourth stopper position. Figure 9(d) shows the plunger rod 400 in the fifth plunger rod position 1226. Accordingly, the first stopper 708 has moved to the fifth stopper position. Figure 9(e) shows the plunger rod 400 in a position between the fifth plunger rod position 1226 and the push plunger rod position 1229. Accordingly, the first stopper 708 has moved. The plunger rod position shown in Figure 9(e) may also be the push-in plunger rod position 1229.

[0118] As shown in the graph of Figure 9a, the plunger rod speed is based on the position of the plunger rod. For example, the plunger rod speed may be the first plunger rod speed 1240 when the plunger rod position is between the retraction plunger rod position 1228 and the fourth plunger rod position 1224. The plunger rod speed may be the second plunger rod speed 1242 when the plunger rod position is between the fifth plunger rod position 1226 and the push plunger rod position 1229. The second plunger rod speed 1242 may be slower than the first plunger rod speed 1240. Alternatively, the second plunger rod speed 1242 may be faster than the first plunger rod speed 1240 for the purpose of effectively emptying the cartridge.

[0119] A plunger rod position may coincide with another plunger rod position. For example, as described in relation to Figure 7, the fourth plunger rod position 1224 may be the first plunger rod position 1220. As described in relation to Figure 7, the fifth plunger rod position 1226 may be the second plunger rod position 1222.

[0120] The plunger rod velocity may decrease as a function of the plunger rod position. For example, the plunger rod velocity may decrease as the plunger rod moves from the fourth plunger rod position 1224 to the fifth plunger rod position 1226. The solid line shows an exemplary linear decrease in the plunger rod velocity as the plunger rod moves from the fourth plunger rod position 1224 to the fifth plunger rod position 1226. Other examples may be nonlinear decreases and stepwise decreases, as illustrated by the dashed line.

[0121] Figure 10 shows a flowchart of an exemplary method 3000 for operating and / or controlling an automatic syringe, such as the automatic syringe described in the previous figure.

[0122] Method 3000 includes the steps of: receiving a cartridge equipped with a first stopper 3001; pushing in a plunger rod and moving it toward a plunger rod position 3002; determining the plunger rod position 3004; receiving a resistance signal 3006; and adjusting the movement of the plunger rod 3010.

[0123] The cartridge receiving step 3001 may include receiving the cartridge into the cartridge receiving section of the autosyner.

[0124] Step 3002 for moving the plunger rod may include pulling the plunger rod back and moving it away from the plunger rod position. Step 3002 for moving the plunger rod may also include moving the plunger rod in the direction of the first plunger rod.

[0125] The step 3004 for determining the plunger rod position may be determined by the processing unit of the automatic syringe. The step 3004 for determining the plunger rod position may also be based on detection from a sensor, such as a plunger rod position sensor equipped with a tachometer.

[0126] Step 3006, which involves receiving a resistance signal, may include receiving a resistance signal from a resistance sensor. The resistance signal may indicate resistance to movement of the plunger rod, such as movement toward the push plunger rod position, for example, movement toward the first plunger rod.

[0127] Step 3010 to adjust the movement may include stopping the movement of the plunger rod. Alternatively or additionally, step 3010 to adjust the movement may include preventing the plunger rod from moving to the retracted plunger rod position for the duration of the residence time, for example, to prevent drug backflow. Alternatively or additionally, step 3010 to adjust the movement may include maintaining the position of the plunger rod for the duration of the residence time, for example, to prevent drug backflow. Alternatively or additionally, step 3010 to adjust the movement may include moving the plunger rod to the retracted plunger rod position. Alternatively or additionally, step 3010 to adjust the movement may include reducing the plunger rod speed.

[0128] The step 3010 for adjusting the movement of the plunger rod may be based on a resistance signal. For example, the movement of the plunger rod may be adjusted so that the resistance is kept below a high resistance threshold. The step 3010 for adjusting the movement of the plunger rod may include adjusting the movement of the plunger rod when the resistance signal indicates resistance to movement of the plunger rod beyond a high resistance threshold. The high resistance threshold may be based on the plunger rod position, for example, a first high resistance threshold when the plunger rod position is within one range, and a second high resistance threshold when the plunger rod position is within a second range.

[0129] The steps of the exemplary method 3000, for example, the step 3002 of moving the plunger rod, the step 3004 of determining the plunger rod position, the step 3006 of receiving a resistance signal, and the step 3010 of adjusting the movement of the plunger rod, may be controlled by a processing unit such as the processing unit of an automatic syringe.

[0130] Figure 11 shows a flowchart of an exemplary method 3300 for moving the plunger rod of an automatic syringe.

[0131] First, the plunger rod is moved, for example, in the direction of the first plunger rod, and at, for example, the velocity of the first plunger rod.

[0132] The resistance to the movement of the plunger rod is monitored, for example, continuously. A first resistance criterion 3304 determines whether the resistance to the movement of the plunger rod exceeds a second high resistance threshold. If the resistance to the movement of the plunger rod does not exceed the second high resistance threshold (the first resistance criterion 3304 answers no), a second resistance criterion 3308 determines whether the resistance to the movement of the plunger rod exceeds the first high resistance threshold. If the resistance to the movement of the plunger rod does not exceed the first high resistance threshold (the second resistance criterion 3304 answers no), the movement of the plunger rod continues 3302. The first plunger threshold may be lower than the second high resistance threshold.

[0133] The position of the plunger rod is monitored, for example, continuously. If the resistance to the movement of the plunger rod exceeds a first high resistance threshold (second resistance criterion 3308 answers yes), the first position criterion 3310 determines whether the plunger rod has reached and / or passed through a predetermined plunger rod position, such as the first plunger rod position, the second plunger rod position, the third plunger rod position, the fourth plunger rod position, and / or the fifth plunger rod position (see, for example, Figures 7 and 9 for exemplary positions). If the plunger rod position reaches and / or passes through a predetermined plunger rod position (first position criterion 3310 answers yes), the movement of the plunger rod continues 3302. Therefore, if the plunger rod reaches and / or passes through a predetermined plunger rod position, the first high resistance threshold may be exceeded.

[0134] If the plunger rod position has not reached and / or passed through a predetermined plunger rod position (the first position criterion 3310 responds "no"), the movement of the plunger rod stops 3312, and an error is communicated to the user, for example, through the user interface. Therefore, an error may occur if the first high resistance threshold is exceeded before the plunger rod reaches and / or passes through a predetermined plunger rod position.

[0135] If the resistance to the movement of the plunger rod exceeds the second high resistance threshold (the first resistance criterion 3304 answers yes), the movement of the plunger rod is stopped 3306, and the injection may be considered complete. In the step of stopping the movement of the plunger rod 3306, the plunger rod may be locked in place for a period of time, for example, to prevent a sudden drop in pressure inside the cartridge, or to prevent backflow of the drug.

[0136] Figure 12 shows a flowchart of an exemplary method 3100 for moving the plunger rod of an automatic syringe.

[0137] First, the plunger rod moves 3102 in the direction of the first plunger rod at a first plunger rod velocity.

[0138] The resistance to the movement of the plunger rod is monitored, for example, continuously. A first resistance criterion 3104 determines whether the resistance to the movement of the plunger rod exceeds a first high resistance threshold. If the resistance to the movement of the plunger rod exceeds the first high resistance threshold (the first resistance criterion 3104 answers yes), the movement of the plunger rod is stopped 3106, and an error is communicated to the user, for example, through a user interface.

[0139] The position of the plunger rod is monitored, for example, continuously. If the resistance to the movement of the plunger rod does not exceed a first high resistance threshold (first resistance criterion 3104 answers no), the first position criterion 3108 determines whether the plunger rod has reached and / or passed through a predetermined plunger rod position, such as the first plunger rod position, the second plunger rod position, the third plunger rod position, the fourth plunger rod position, and / or the fifth plunger rod position (see, for example, Figures 7 and 9 for exemplary positions). If the plunger rod position has not reached and / or passed through a predetermined plunger rod position (first position criterion 3108 answers no), the movement of the plunger rod continues at the first plunger rod speed 3102.

[0140] When the plunger rod position reaches and / or passes a predetermined plunger rod position (the first position criterion 3108 answers yes), the plunger rod moves 3110 at a second plunger rod speed, for example, in the direction of the first plunger rod. The second plunger rod speed may be slower than the first plunger rod speed. By reducing the plunger rod speed, the amount of drug that needs to be pushed into the needle per unit time is reduced, thereby reducing the amount of force required to advance the stopper.

[0141] The second resistance criterion 3112 determines whether the resistance to the movement of the plunger rod exceeds the second high resistance threshold. If the resistance to the movement of the plunger rod does not exceed the second high resistance threshold (the second resistance criterion 3112 answers "no"), the movement of the plunger rod continues at the second plunger rod speed 3110.

[0142] If the resistance to the movement of the plunger rod exceeds the second high resistance threshold (the second resistance criterion 3112 answers yes), the movement of the plunger rod stops 3114, and the injection may be considered complete. In the step of stopping the movement of the plunger rod 3114, the plunger rod may be locked in place for a period of time, for example, to prevent a sudden drop in pressure inside the cartridge, or to prevent backflow of the drug.

[0143] Figure 13 shows a flowchart of an exemplary method 3200 for moving the plunger rod of an automatic syringe.

[0144] First, the plunger rod is moved, for example, in the direction of the first plunger rod, and at, for example, the velocity of the first plunger rod.

[0145] The resistance to the movement of the plunger rod is monitored, for example, continuously. The resistance criterion 3204 determines whether the resistance to the movement of the plunger rod exceeds high resistance thresholds, such as a first high resistance threshold and / or a second high resistance threshold.

[0146] If the resistance to the movement of the plunger rod does not exceed the high resistance threshold (resistance criterion 3204 answers "no"), the movement speed of the plunger rod increases 3206.

[0147] If the resistance to the movement of the plunger rod exceeds the high resistance threshold (resistance criterion 3204 answers yes), then velocity criterion 3208 determines whether the plunger rod velocity is zero, i.e., whether the plunger rod is not moving.

[0148] If the plunger rod speed is not zero (speed criterion 3208 answers no), the plunger rod speed decreases 3210. If the plunger rod speed is zero (speed criterion 3208 answers yes), the process is stopped 3212. In the stopping step 3212, the plunger rod may be locked in place for a period of time, for example, to prevent a sudden drop in pressure in the cartridge, or to prevent backflow of the drug.

[0149] The high resistance threshold of the resistance criterion 3204 may be determined based on the position of the plunger rod. In the process of stopping the process 3212, the position of the plunger rod may be used to determine whether sufficient chemicals have been discharged and / or whether an error has stopped the process prematurely. Corresponding messages are provided to the user, for example, through a user interface.

[0150] Method 3200 adjusts the speed to be as fast as possible without exceeding the resistance threshold.

[0151] Figure 14 shows a flowchart of an exemplary method 3400 for moving the plunger rod of an automatic syringe.

[0152] First, the plunger rod is moved, for example, in the direction of the first plunger rod, at, for example, the velocity of the first plunger rod.

[0153] The resistance to the movement of the plunger rod is monitored, for example, continuously. A first resistance criterion 3404 determines whether the resistance to the movement of the plunger rod exceeds a first high resistance threshold.

[0154] If the resistance to the movement of the plunger rod does not exceed the first high resistance threshold (the first resistance criterion 3404 is answered as no), the movement speed of the plunger rod increases 3406.

[0155] The position of the plunger rod is monitored, for example, continuously. If the resistance to the movement of the plunger rod exceeds a first high resistance threshold (first resistance criterion 3404 answers yes), the first position criterion 3408 determines whether the plunger rod has reached and / or passed through a predetermined plunger rod position, such as the first plunger rod position, the second plunger rod position, the third plunger rod position, the fourth plunger rod position, and / or the fifth plunger rod position (see, for example, Figures 7 and 9 for exemplary positions).

[0156] If the plunger rod position has not reached and / or passed through a predetermined plunger rod position (the first position criterion 3408 is answered as no), the movement speed of the plunger rod decreases 3410.

[0157] If the plunger rod position reaches and / or passes a predetermined plunger rod position (the first position criterion 3408 answers yes), the movement of the plunger rod may continue. Therefore, if the plunger rod reaches and / or passes a predetermined plunger rod position, the first high resistance threshold may be exceeded. In this case, the second resistance criterion 3412 determines whether the resistance to the movement of the plunger rod exceeds the second high resistance threshold.

[0158] If the resistance to the movement of the plunger rod does not exceed the second high resistance threshold (the second resistance criterion 3412 is answered as no), the movement speed of the plunger rod increases 3406.

[0159] If the resistance to the movement of the plunger rod exceeds the second high resistance threshold (the second resistance criterion 3412 answers yes), the velocity criterion 3414 determines whether the plunger rod velocity is zero, i.e., whether the plunger rod is not moving.

[0160] If the plunger rod speed is not zero (speed criterion 3414 answers no), the plunger rod speed decreases 3410. If the plunger rod speed is zero (speed criterion 3414 answers yes), the process is stopped 3416. In the stopping step 3416, the plunger rod may be locked in place for the duration of the residence time, for example to prevent a sudden drop in pressure in the cartridge, or to prevent backflow of the drug. In the stopping step 3416, the completion of the injection may be assumed. Method 3400 adjusts the speed to be as high as possible without exceeding the resistance threshold.

[0161] While certain features have been shown and described, it will be understood that these are not intended to limit the claimed invention. Furthermore, it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the essence and scope of the claimed invention. Therefore, the specification and drawings should be considered illustrative rather than restrictive. The claimed invention is intended to encompass all alternatives, modifications, and equivalents. [Explanation of symbols]

[0162] 2 Systems 4 auto-injector 6 Housing 10 batteries 20 Processing Units 22 Directional Sensors 24 Code Sensors 26 Plunger rod position sensor 28 Cartridge Sensor 30 Needle Sensor 32 Temperature Sensors 34 Resistance Sensor 300 Cartridge receiving section 301 Cartridge receiving opening 304 Reception direction 400 Plunger Rod 402 Inner plunger rod 404 Outer plunger rod 500 drive module 502 Motor 600 cartridge assembly 700 cartridges 701 Dual Chamber Cartridge 702 Cartridge Components 704 First Cartridge Subcomponent 706 Second Cartridge Subcomponent 708 First Stopper 710 Second Stopper 712 Bypass Section 714 Cartridge Outlet 716 Cartridge back 718 First end 720 Second end 722 First stopper direction 800 Cartridge Holder 808 Cartridge holding member 812 Needle Assembly Connection 900 Needle Assembly 902 needle 904 Needle Hub 906 Cartridge holder connecting part 908 Needle Cover 1000 Cartridge Code Function 1100 User Interface 1102 Contact Member 1108 First input member 1110 First output component 1200 Resistance Graph 1200X position axis 1200Y resistance axis 1201 First high resistance threshold 1202 Second High Resistance Threshold 1204 Third High Resistance Threshold 1206 First Slope 1208 Second Slope 1210 Third Slope 1220 Position of the first plunger rod 1222 Position of the second plunger rod 1223 Position of the third plunger rod 1224 Position of the 4th plunger rod 1226 Position of the 5th plunger rod 1228 Pull-back plunger rod position 1229 Push-in plunger rod position 1240 First plunger rod speed 1242 Second plunger rod speed 1300 Speed ​​Graph 1300X position axis 1300Y speed axis 3000 ways 3001 Acceptance process 3002 Moving process 3004 Decision-making process 3006 Receiving process 3010 Adjustment process 3100 method 3102 Move the plunger rod at the first speed. 3104 1st resistance standard 3106 Stop the movement of the plunger rod. 3108 1st position reference 3110 Move the plunger rod at the second speed. 3112 2nd resistance standard 3114 Stop the movement of the plunger rod. 3200 method 3202 Move the plunger rod at the first speed. 3204 Resistance Reference 3206 Increase speed 3208 Speed ​​Standard 3210 Reduce speed 3212 Stop the movement of the plunger rod. 3300 method 3302 Move the plunger rod at the first speed. 3304 1st resistance standard 3306 Stop the movement of the plunger rod. 3308 2nd resistance standard 3310 1st position reference 3312 Stop the movement of the plunger rod. 3400 method 3402 Move the plunger rod at the first speed. 3404 1st resistance standard 3406 Increase speed 3408 1st position reference 3410 Reduce speed 3412 2nd resistance standard 3414 Speed ​​Standard 3416 Stop the movement of the plunger rod.

Claims

1. An automatic syringe for administering medication, Housing and A cartridge receiving section configured to receive a cartridge equipped with a first stopper, A drive module is connected to a plunger rod configured to move the first stopper, so as to move the plunger rod between the pull-back plunger rod position and the push-in plunger rod position, A resistance sensor configured to provide a resistance signal indicating resistance to the movement of the plunger rod, The drive module and the resistance sensor are connected to a processing unit, Equipped with, The aforementioned processing unit, The drive module is configured to control the plunger rod to move toward the push plunger rod position at the plunger rod speed, It is configured to determine the plunger rod position, It is configured to receive the aforementioned resistance signal, and The drive module is configured to control and adjust the movement of the plunger rod when the resistance signal indicates resistance to movement exceeding a high resistance threshold of the plunger rod. The aforementioned high resistance threshold is based on the plunger rod position in an automatic syringe.

2. The high resistance threshold is a first high resistance threshold when the plunger rod position is between the pull-back plunger rod position and the first plunger rod position, and the high resistance threshold is a second high resistance threshold when the plunger rod position is between the second plunger rod position and the push-in plunger rod position, and the second high resistance threshold is higher than the first high resistance threshold. The automatic syringe according to claim 1.

3. The first high-resistance threshold is between 50 and 80 N, for example, 50 N, 55 N, 60 N, 65 N, 70 N, 75 N, or 80 N. The automatic syringe according to claim 2.

4. The first high resistance threshold is 55N. The automatic syringe according to claim 3.

5. The second high resistance threshold is between 70 and 100 N, for example between 75 and 85 N, or for example between 80 and 90 N, or for example 70 N, 75 N, 80 N, 85 N, or 90 N. An automatic syringe according to any one of claims 2 to 4.

6. The second high resistance threshold is 80 N. The automatic syringe according to claim 5.

7. The high resistance threshold is a third high resistance threshold when the plunger rod position is between the first plunger rod position and the second plunger rod position, and the third high resistance threshold is higher than the first high resistance threshold and lower than the second high resistance threshold. An automatic syringe according to any one of claims 2 to 6.

8. The third high resistance threshold increases as the plunger rod position moves from the first plunger rod position to the second plunger rod position. The automatic syringe according to claim 7.

9. The distance between the push plunger rod position and the first plunger rod position is between 1 and 3 mm, for example, 2 mm. An automatic syringe according to any one of claims 2 to 8.

10. The distance between the retraction plunger rod position and the first plunger rod position is between 0 and 60 mm. An automatic syringe according to any one of claims 2 to 9.

11. The distance between the retraction plunger rod position and the first plunger rod position is between 50 and 60 mm, for example, 55 mm, 56 mm, or 57 mm. An automatic syringe according to any one of claims 2 to 10.

12. The system includes a code sensor configured to read the cartridge code function, the processing unit is connected to the code sensor, the processing unit is configured to receive a code signal indicating the cartridge code function from the code sensor, and the processing unit is configured to determine the position of the first plunger rod and / or the position of the second plunger rod based on the code signal. An automatic syringe according to any one of claims 2 to 11.

13. The resistance sensor is configured to determine the current passing through the drive module. An automatic syringe according to any one of claims 1 to 12.

14. The resistance sensor is configured to measure the pressure and / or force applied to the front end of the plunger rod. An automatic syringe according to any one of claims 1 to 13.

15. The drive module is equipped with a tachometer configured to provide a tachometer signal indicating the rotational speed of the drive module, the processing unit is connected to the tachometer, and the processing unit is configured to receive the tachometer signal and determine the plunger rod position based on the tachometer signal. An automatic syringe according to any one of claims 1 to 14.

16. Adjusting the movement of the plunger rod includes stopping the movement of the plunger rod. An automatic syringe according to any one of claims 1 to 15.

17. Adjusting the movement of the plunger rod further includes preventing the plunger rod from moving to the retraction plunger rod position during the residence time. The automatic syringe according to claim 16.

18. Adjusting the movement of the plunger rod includes moving the plunger rod to the position of the retraction plunger rod. An automatic syringe according to any one of claims 1 to 17.

19. Adjusting the movement of the plunger rod includes reducing the speed of the plunger rod. An automatic syringe according to any one of claims 1 to 18.

20. The processing unit is further configured to adjust the movement of the plunger rod and then control the drive module to readjust the movement of the plunger rod if the resistance signal indicates that the resistance to the movement of the plunger rod falls below the high resistance threshold. An automatic syringe according to any one of claims 1 to 19.

21. Adjusting the movement of the plunger rod includes increasing the speed of the plunger rod. The automatic syringe according to claim 20.

22. The plunger rod speed is based on the plunger rod position. An automatic syringe according to any one of claims 1 to 21.

23. The plunger rod speed is the first plunger rod speed when the plunger rod position is between the pull-back plunger rod position and the fourth plunger rod position, and the plunger rod speed is the second plunger rod speed when the plunger rod position is between the fifth plunger rod position and the push-in plunger rod position, and the second plunger rod speed is slower than the first plunger rod speed. The automatic syringe according to claim 22.

24. The plunger rod speed is the first plunger rod speed when the plunger rod position is between the pull-back plunger rod position and the fourth plunger rod position, and the plunger rod speed is the second plunger rod speed when the plunger rod position is between the fifth plunger rod position and the push-in plunger rod position, and the second plunger rod speed is faster than the first plunger rod speed. The automatic syringe according to claim 22.

25. A system comprising an automatic syringe according to any one of claims 1 to 24 and a cartridge having a first stopper, wherein the cartridge is configured to be received in a cartridge receiving section.

26. The aforementioned cartridge is a dual-chamber cartridge. The system according to claim 25.

27. A method for controlling an automatic syringe, wherein the method is A process for receiving a cartridge equipped with a first stopper, The process involves pushing the plunger rod in at the plunger rod speed and moving it toward the plunger rod position, The process of determining the plunger rod position, The process of receiving a resistance signal indicating resistance to the movement of the plunger rod, When the resistance signal indicates resistance to movement of the plunger rod exceeding a high resistance threshold, the step of adjusting the movement of the plunger rod is performed. A method comprising the above, wherein the high resistance threshold is based on the plunger rod position.

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