Drug injection device and method

The electroosmotic pump-based drug infusion device addresses clogging issues in insulin injectors by alternating pressures for stable and precise drug delivery, ensuring consistent operation.

JP2025527026AActive Publication Date: 2025-08-15CAREMEDI CO LTD +1
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Patent Information

Application Number
JP2025512001
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-06-07
Filing Date
2023-06-26
Publication Date
2025-08-15
Estimated Expiration
2043-06-26

AI Technical Summary

Technical Problem

Insulin injectors face challenges in stable operation due to back pressure at the cannula tip caused by drug-biological fluid reactions, particularly when injecting small amounts or at slow rates, leading to clogging issues.

Method used

A drug infusion device using an electroosmotic pump driven by electrochemical means, with a controller implementing a volume-based infusion sequence that alternates negative and positive pressures through forward and reverse pulses to ensure precise drug delivery without clogging.

Benefits of technology

The device ensures stable and precise drug injection by alternately generating negative and positive pressures, preventing clogging and maintaining consistent delivery, even with small or slow drug amounts.

✦ Generated by Eureka AI based on patent content.

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Abstract

A drug infusion device according to the present invention includes a drug injector that electrochemically drives an electroosmotic pump to aspirate a drug from a drug reservoir and eject the aspirated drug into an injection target, and a controller that outputs a control signal to the drug injector corresponding to a volume-based injection sequence that drives the electroosmotic pump in an immediate injection mode, the volume-based injection sequence including at least one pulse block that defines voltage pulses or current pulses to be applied to the electroosmotic pump, each pulse block defining a pair of pulse signals including a forward pulse and a reverse pulse that are applied to the electroosmotic pump and generate alternating negative and positive pressures, and the electroosmotic pump generates alternating negative and positive pressures for each pulse block to aspirate and eject the drug.
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Description

[Technical Field]

[0001] The present invention relates to a drug infusion device and method. [Background technology]

[0002] Drugs can be injected into the body in various ways, such as orally, subcutaneously, or intravenously, depending on the type, purpose, and method of treatment. Drug injectors using drug pumps can automatically inject drugs into the body at a desired rate and volume at a required time. Therefore, drug injectors using drug pumps can be used in a variety of ways, not only in hospitals and in patients' daily lives.

[0003] Insulin pumps, commonly known as insulin syringes, are medical devices for diabetics who do not secrete insulin or who secrete only small amounts of it. They act like the pancreas, supplying insulin to the body from the outside at precise times to regulate blood sugar levels.

[0004] Such insulin pumps are used by insulin-dependent diabetics and can inject medication continuously 24 hours a day while worn by the patient. Because insulin injectors must inject medication into diabetics regularly over a long period of time, active technological development is underway to miniaturize and automate insulin injectors for user convenience.

[0005] However, as insulin injectors become smaller and more automated, it can be difficult to ensure stable operation of the insulin injector. This is mainly due to back pressure at the tip of the cannula or needle caused by various reactions between the drug and biological fluids. This clogging problem becomes more serious when the amount of drug being injected is small or is injected slowly.

[0006] Therefore, there is a need for a method for continuously injecting a drug into a patient, while at the same time stably injecting a precise amount of drug and controlling the drug injection so that the drug injection channel does not become clogged during drug injection. Summary of the Invention [Problem to be solved by the invention]

[0007] SUMMARY OF THE INVENTION In order to solve the above-mentioned problems, the technical object of the present invention is to provide a drug infusion method for real-time infusion with an electroosmotic pump-based drug infusion device.

[0008] However, the technical problem that this embodiment aims to achieve is not limited to the above-mentioned technical problem, and other technical problems may exist. [Means for solving the problem]

[0009] As a technical solution to the above-mentioned technical problems, one embodiment of the present invention provides a drug infusion device that includes a drug injector that electrochemically drives an electroosmotic pump to inhale a drug from a drug reservoir and discharge the inhaled drug into an infusion target, and a controller that outputs a control signal to the drug injector corresponding to a volume-based infusion sequence that drives the electroosmotic pump in an immediate infusion mode, the volume-based infusion sequence including at least one pulse block that defines voltage pulses or current pulses to be applied to the electroosmotic pump, each pulse block defining a pair of pulse signals that include a forward pulse and a reverse pulse that are applied to the electroosmotic pump and generate alternating negative and positive pressures, and the electroosmotic pump alternately generates negative and positive pressures for each pulse block to inhale and discharge the drug.

[0010] Furthermore, a drug infusion method according to one embodiment of the present invention includes the steps of setting a volume-based infusion sequence for operating a drug infusion device in an immediate infusion mode, applying a control signal corresponding to the volume-based infusion sequence to the electroosmotic pump, and, in response to the control signal, causing the electroosmotic pump to alternately generate negative and positive pressure for each pulse block to inhale and expel drug, wherein the volume-based infusion sequence includes at least one pulse block that defines voltage pulses or current pulses to be applied to the electroosmotic pump, and each of the pulse blocks defines a pair of pulse signals that include a forward pulse and a reverse pulse that are applied to the electroosmotic pump to alternately generate negative and positive pressure. [Effects of the Invention]

[0011] According to the above-described means for solving the problems of the present invention, a quantity-based injection sequence according to the drug injection conditions can be set for a drug injector that uses an electroosmotic pump, and the drug injector can be controlled to inject a fixed amount of drug. [Brief explanation of the drawings]

[0012] [Figure 1] 1 is a block diagram illustrating a drug injection device according to an embodiment of the present invention; [Figure 2] FIG. 2 is a block diagram showing a schematic configuration of the drug injector shown in FIG. 1. [Figure 3] FIG. 1 is a conceptual diagram illustrating a volume-based injection sequence according to an embodiment of the present invention. [Figure 4] 10 is a table illustrating an example of multiple pulse blocks according to one embodiment of the present invention. [Figure 5] FIG. 10 is an exemplary diagram illustrating a signal structure for a dose-based injection sequence according to one embodiment of the present invention. [Figure 6] FIG. 10 is an exemplary diagram illustrating a signal structure for a rate-based injection sequence according to one embodiment of the present invention. [Figure 7] 1 is a table illustrating exemplary basal infusion modes according to one embodiment of the present invention. [Figure 8] FIG. 8 is an exemplary diagram illustrating a signal structure for the fundamental injection mode shown in FIG. 7. [Figure 9] 9 is an exemplary diagram showing a signal structure when a dose-based injection sequence is applied to the basal injection mode shown in FIG. 8. [Figure 10] FIG. 3 is a block diagram showing a schematic configuration of the electroosmotic pump shown in FIG. 2. [Figure 11] FIG. 11 is a block diagram schematically illustrating the configuration of a driving unit illustrated in FIG. [Figure 12] 7 is an exemplary diagram illustrating a schematic configuration of a driving unit shown in FIG. 6. FIG. [Figure 13] 1 is an exemplary application diagram of a drug injection device according to an embodiment of the present invention; [Figure 14] FIG. 14 is a block diagram showing the schematic configuration of the drug injection device shown in FIG. 13. [Figure 15] FIG. 14 is a block diagram showing the schematic configuration of the drug injection device shown in FIG. 13. [Figure 16] 1 is a flow chart illustrating a drug injection method according to an embodiment of the present invention. [Figure 17] 17 is a flow chart illustrating a process of applying the control signals shown in FIG. 16 to an electroosmotic pump. DETAILED DESCRIPTION OF THE INVENTION

[0013] The present invention will be described in detail below with reference to the accompanying drawings. However, the present invention may be embodied in various different forms and is not limited to the embodiments described herein. Furthermore, the accompanying drawings are merely provided to facilitate understanding of the embodiments disclosed herein, and the technical ideas disclosed herein are not limited by the accompanying drawings. To clearly illustrate the present invention in the drawings, parts that are not relevant to the description are omitted, and the size, shape, and form of each component shown in the drawings may be modified in various ways. The same or similar reference numerals are used throughout the specification to refer to the same or similar parts.

[0014] The suffixes "module" and "section" used in the following description for components are given or used interchangeably only for the sake of ease of drafting the specification, and do not have any distinct meanings or roles. Furthermore, in describing the embodiments disclosed herein, if it is determined that a detailed description of related publicly known technology may obscure the gist of the embodiments disclosed herein, such a detailed description has been omitted.

[0015] Throughout this specification, a part being "coupled (connected, in contact, or coupled)" to another part includes not only a "directly coupled (connected, in contact, or coupled)" part, but also an "indirectly coupled (connected, in contact, or coupled)" part with another member interposed therebetween. Furthermore, when a part "includes (comprises or comprises)" a certain component, it does not exclude other components, but means that it may further "include (comprises or comprises)" the other components, unless otherwise specified.

[0016] As used herein, ordinal terms such as "first," "second," etc. are used only to distinguish one component from another, and do not limit the order or relationship of the components. For example, a first component of the present invention may be designated as a second component, and similarly, the second component may be designated as a first component.

[0017] FIG. 1 is a block diagram showing the configuration of a drug injection device according to one embodiment of the present invention, and FIG. 2 is a block diagram showing the configuration of the drug injector shown in FIG.

[0018] Referring to FIGS. 1 and 2, a drug injection device (10) according to one embodiment of the present invention will be described. The drug injection device (10) includes a drug injector (100) and a control unit (200).

[0019] The drug injector (100) electrochemically operates the electroosmotic pump (110) in an immediate injection mode to inhale a drug from a drug reservoir and discharge the inhaled drug into the injectee. The control unit (200) outputs a control signal corresponding to a volume-based injection sequence to the drug injector (100) to operate the electroosmotic pump (110) in the immediate injection mode. The immediate injection mode is a drug injector mode in which a predetermined amount of drug is immediately injected into a user to lower the user's blood glucose level to a normal range when the user's blood glucose level has suddenly increased or is expected to increase.

[0020] The control unit (200) may refer to a data processing device built into hardware having a circuit physically structured to perform functions expressed by codes or commands contained in a program. Examples of such data processing devices built into hardware include a microprocessor, a central processing unit (CPU), a processor core, a multiprocessor, an application-specific integrated circuit (ASIC), a field programmable gate array (FPGA), a microcontroller unit (MCU), an embedded processor, etc., but the scope of the present invention is not limited thereto.

[0021] Meanwhile, the control unit (200) may be implemented not only as a separate unit built into the drug injection device (10), but also as a unit connected to the user terminal (40) described below via a communication module, whereby the user terminal (40) and the control unit (200) are integrated to control the instantaneous injection mode of the drug injection device (10).

[0022] FIG. 3 is a diagram illustrating the concept of a dose-based injection sequence according to one embodiment of the present invention. The dose-based injection sequence will be specifically described with reference to FIG.

[0023] A volume-based infusion sequence is a sequence of pulse blocks (20) that satisfy a drug infusion volume according to drug infusion conditions, including the drug infusion volume. An immediate infusion sequence is a sequence of pulse blocks (20) that satisfy a drug infusion volume, arranged consecutively without intervals. Immediate infusion is sometimes defined as bolus infusion in conventional insulin infusion devices.

[0024] 3, a volume-based infusion sequence comprises multiple pulse blocks (20) arranged consecutively with no rest between them. The pulse blocks (20) define voltage or current pulses applied to the electroosmotic pump (110) whose durations vary to infuse different amounts of drug.

[0025] FIG. 4 is a table illustrating an example of multiple pulse blocks according to one embodiment of the present invention, and FIG. 5 is an exemplary diagram illustrating a signal structure for a dose-based injection sequence according to one embodiment of the present invention.

[0026] 4 and 5, the structure of the amount-based infusion sequence will be described by way of example. The amount-based infusion sequence is set as follows to satisfy drug infusion conditions, including the drug infusion amount. The amount-based infusion sequence has a structure in which M (M is a natural number equal to or smaller than N) pulse blocks 20 selected according to the drug infusion amount are consecutively arranged from among N (N is a natural number greater than or equal to 1) pulse blocks 20 that supply different amounts of drug shown in FIG. 4. Here, the minimum number of pulse blocks 20 that can satisfy the drug infusion amount can be used for the multiple pulse blocks 20 that make up the amount-based infusion sequence, and among the pulse blocks 20 that can satisfy the drug infusion amount, the pulse block 20 that supplies the largest amount of drug is preferentially arranged.

[0027] For example, if the drug injection volume is 5 μL, the volume-based injection sequence would consist of a fourth pulse block delivering 3 μL and a third pulse block delivering 2 μL, with the fourth pulse block placed first and the third pulse block placed second. The fourth and third pulse blocks are then immediately followed by the third pulse block upon completion of the fourth pulse block without a gap.

[0028] 4 and 5, each pulse block 20 includes information about a pair of pulse signals including a forward pulse and a reverse pulse, and information about the amplitude and duration of each pulse. The pair of pulse signals including a forward pulse and a reverse pulse are applied to the electroosmotic pump 110 to generate alternating negative and positive pressures, thereby generating alternating negative and positive pressures in each pulse block 20, thereby inhaling and exhaling the drug.

[0029] The pair of pulse signals (21, 22) included in the pulse block (20) are voltage pulse signals or current pulse signals. The pair of voltage pulse signals may be composed of a forward voltage pulse and a reverse voltage pulse, and the pair of current pulse signals may be composed of a forward current pulse and a reverse current pulse. Here, the pair of voltage pulse signals may include information regarding the magnitude and duration of each voltage pulse, and the pair of current pulse signals may include information regarding the magnitude and duration of each current pulse. For example, in the dose-based injection sequence shown in FIG. 5, the magnitude of the pulse signals may be 2 V and the maintenance time may be 10 seconds.

[0030] Each pulse block 20 included in a dose-based injection sequence can include voltage pulses having different voltage magnitudes or current pulses having different current magnitudes, or each pulse block 20 can include pulses having the same voltage magnitude or current magnitude but with different durations.

[0031] The forward pulse (21) and the reverse pulse (22) included in the pulse block (20) are set to have the same magnitude and duration, so that the amount of drug inhaled and expelled by the electroosmotic pump (110) can be maintained the same.

[0032] Furthermore, the pair of pulse signals (21, 22) included in the pulse block (20) may be provided at a constant voltage or a constant current, and the amount of drug inhaled and exhaled by each pulse block may be adjusted by adjusting the duration of the pulse signal provided by the constant voltage or constant current. For example, the pulse block (20) in FIG. 5 is provided at a constant voltage of 2 V.

[0033] Furthermore, the pair of pulse signals (21, 22) can be adjusted in both magnitude and duration so that the amounts of inhaled and exhaled drug are equal. For example, the forward voltage pulse can be set to a magnitude of 2 V and a duration of 10 s, and the subsequent reverse voltage pulse can be set to a magnitude of 1 V and a duration of 20 s, so that the areas of the forward pulse and the reverse pulse are set to be the same, thereby maintaining the amounts of inhaled and exhaled drug equal.

[0034] Each pulse block 20 may further include a stabilization pulse 23, which maintains a 0 V voltage for a predetermined time after the application of the forward voltage pulse 21 and the reverse voltage pulse 22. The stabilization pulse 23 may stabilize the operation of the electroosmotic pump 110. Here, if the pulse block 20 of the volume-based injection sequence is composed of a pair of current pulses, the pulse block 20 may further include a stabilization pulse 23, which maintains a 0 A current for a predetermined time after the application of the forward current pulse and the reverse current pulse.

[0035] The control unit 200 generates a control signal consisting of a voltage pulse or a current pulse corresponding to the volume-based injection sequence based on the information of the pulse block 20 included in the volume-based injection sequence, and applies the control signal to the drug injector 100. Upon receiving the control signal, the drug injector 100 immediately performs an immediate injection mode through the volume-based injection sequence, but if the drug injector 100 is operating in a basal injection mode using a preset rate-based injection sequence, the control unit 200 temporarily suspends output of the control signal corresponding to the rate-based injection sequence and outputs a control signal corresponding to the volume-based injection sequence to the drug injector 100.

[0036] Thereafter, when the drug injector 100 completes the immediate injection mode, the control unit 200 again outputs a control signal for the temporarily suspended rate-based injection sequence to the drug injector 100. Here, the control unit 200 omits the operations set in the rate-based injection sequence while the immediate injection mode is being performed, and outputs a control signal for the rate-based injection sequence set at the time when the operation of the immediate injection mode is completed.

[0037] 6 is an exemplary diagram showing the signal structure of a basal injection sequence according to one embodiment of the present invention. Referring to FIG. 6, the rate-based injection sequence includes at least one pulse block (20) that defines a voltage pulse or current pulse to be applied to the electroosmotic pump (110), and at least one pause block (30) that maintains a 0 V voltage or 0 A current for a predetermined time after the application of the pulse block.

[0038] The basal infusion mode is a mode in which multiple rate-based infusion sequences are arranged consecutively during a set drug infusion period. In the basal infusion mode, the drug infusion period can be divided into multiple sequences according to user settings. Here, each segment includes information on the duration and the drug infusion rate during the duration, and each segment is configured by repeatedly arranging the rate-based infusion sequence set per unit time to satisfy the drug infusion rate during the duration. Here, the duration and drug infusion rate of each segment can be set by the user.

[0039] FIG. 7 is a table showing an example of a basal injection mode according to one embodiment of the present invention, FIG. 8 is an example diagram showing a signal structure for the basal injection mode shown in FIG. 7, and FIG. 9 is an example diagram showing a signal structure when a dose-based injection sequence is applied to the basal injection mode shown in FIG. 8.

[0040] The basal infusion mode will be described with reference to FIGS. 7 and 8. In the basal infusion mode shown in FIG. 7, 24 hours are divided into a plurality of segments, each of which has a set duration and a drug infusion rate. The drug injector 100 performs the basal infusion mode by progressing through each segment in the order shown in FIG. 8. If the drug injector 100 performs the second segment and executes the immediate infusion mode at time t1, a volume-based infusion sequence is placed in the middle of the second segment, as shown in FIG. 9, and the volume-based infusion sequence is executed. Then, when the immediate infusion mode ends at time t2, the control unit 200 transmits the rate-based infusion sequence set at time t2 to the drug injector 100, and the drug injector 100 resumes the basal infusion mode. Here, the portion of the rate-based infusion sequence from time t1 to time t2 is omitted due to the volume-based infusion sequence.

[0041] When a control signal corresponding to such a volume-based injection sequence is applied to the electroosmotic pump 110, the electroosmotic pump 110 generates alternating negative and positive pressures in each pulse block, drawing in and expelling the drug. Here, the control signal may be a signal consisting of a voltage pulse pair including a forward voltage pulse and a reverse voltage pulse or a current pulse pair including a forward current pulse and a reverse current pulse for each pulse block 20.

[0042] FIG. 10 is a block diagram showing a schematic configuration of the electroosmotic pump shown in FIG.

[0043] 10, the electroosmotic pump 110 includes a driving unit 111 and a chamber 112. The driving unit 111 is electrochemically driven by a control signal to generate positive and negative pressures, which then expel a drug, and the chamber 112 draws in the drug from the drug reservoir 120 using the pressure of the driving unit 111, and then expels the drug into the insertion unit 130. Here, the drug is a drug to be injected into a specific patient, such as insulin for diabetes patients.

[0044] FIG. 11 is a block diagram schematically illustrating the configuration of the driving unit shown in FIG. 10, and FIG. 12 is an exemplary diagram schematically illustrating the configuration of the driving unit shown in FIG.

[0045] 11 and 12, the driving unit (111) is a pump that utilizes the electroosmotic phenomenon that occurs when a voltage or current is applied to both ends of a porous membrane (membrane 111a) using electrodes, causing fluid to move. The driving unit (111) includes a power source (111d) that applies a voltage or current to the membrane (111a) and first and second electrodes (111b and 111c) disposed on both sides of the membrane (111a), and a flow path for the fluid to move.

[0046] The actuator 111 may also include a first diaphragm 111e disposed adjacent to the first electrode 111b and a second diaphragm 111f disposed adjacent to the second electrode 111c. Each diaphragm 111e, 111f is provided on one side and the other side of the membrane 111a, and changes shape as the pumping solution moves due to the alternating generation of positive and negative pressures. For example, the first diaphragm 111e and the second diaphragm 111f transmit the negative and positive pressures generated by the actuation of the membrane 111a to the fluid to be pumped. More specifically, when negative pressure is generated, at least a portion of the first diaphragm (111e) and the second diaphragm (111f) retreats (when they move in the direction of the circled number 1), and the fluid to be transferred is sucked into the chamber (112); conversely, when positive pressure is generated, at least a portion of the first diaphragm (111e) and the second diaphragm advances (when they move in the direction of the circled number 2), and the fluid to be transferred is discharged from the chamber (112).

[0047] The porous membrane (111a) is typically made of silica or glass, which becomes negatively charged when immersed in an aqueous solution. The porous membrane (111a) has numerous fluid-passing channels. A close-up of one of these channels reveals that the negatively charged fluid surface can be balanced by mobile positively charged cations. Applying a positive voltage to the first electrode (111b) and a negative voltage to the second electrode (111c) generates negative pressure, which moves the fluid inside the actuator (111) in the direction indicated by the circled number 1. The drug is then inhaled through the inhalation channel (141) and flows into the chamber (112) via the inhalation valve (140). The discharge valve (150) is closed, preventing negative pressure from being transmitted to the discharge channel (151). Conversely, when a negative voltage is applied to the first electrode (111b) and a positive voltage is applied to the second electrode (111c), a reversible electrochemical reaction generates a positive pressure in the opposite direction. This positive pressure causes the fluid inside the actuator (111) to move in the direction of the circled number 2. At this time, the drug stored in the chamber (112) flows into the subject through the discharge valve (150) and the discharge passage (151). At this time, the intake valve (140) is closed, preventing positive pressure from being transmitted to the intake passage (141).

[0048] This phenomenon is called electroosmosis, and the pump that utilizes this principle is the electroosmotic pump (110).

[0049] The electrodes used in the driving unit (111) may be provided in the form of porous electrodes such as platinum mesh, porous carbon paper or fiber, or various electrode materials coated on a porous structure to facilitate fluid movement.

[0050] In addition, the electrodes used in the actuator 111 may be applied to a non-transparent substrate and coated with various immobilizable materials by drop coating, spin coating, etc. In this case, the non-transparent substrate may be a plate-shaped substrate including at least one of a conductive material, a semiconductor material, and a non-conductive material, and the electrode material coated thereon may be a metal, a metal oxide, a conducting polymer, a metal hexacyanoferrate, a carbon nanostructure, or a composite thereof.

[0051] The driving unit (111) alternately supplies voltage or current polarity to the first electrode (111b) and the second electrode (111c), respectively, causing reversible forward and reverse electrochemical reactions. The repeated forward and reverse electrochemical reactions cause the fluid inside the electroosmotic pump to repeatedly reciprocate. The repeated reversible forward and reverse electrochemical reactions also cause the fluid to be repeatedly consumed and regenerated at the first electrode (111b) and the second electrode (111c). When the suction valve (140) and the discharge valve (150) are respectively connected to the chamber (112) of the electroosmotic pump (110), the drug in the drug reservoir (120) is drawn in through the suction passage (141) during the suction operation, passes through the suction valve (140), and is stored in the chamber (112). During the discharge operation, the medicine stored in the chamber (112) is discharged through the discharge valve (150) and the discharge passage (151) into the insertion part (130).

[0052] Therefore, the pressure generated by the electroosmotic pump (110) and the volume of the drug discharged can be controlled by controlling the magnitude and duration of the voltage or current applied to the first and second electrodes (111b, 111c).

[0053] Figure 13 is a diagram showing an application example of a drug injection device according to one embodiment of the present invention, Figure 14 is a block diagram showing a schematic configuration of the drug injection device shown in Figure 13, and Figure 15 is a block diagram showing a schematic configuration of the drug injection device shown in Figure 13. The operation of drug injection device 10 will be described in detail with reference to Figures 13 to 15.

[0054] The drug injection device 10 receives predetermined information from the user and sets up a volume-based infusion sequence based on the information. The process of setting up a volume-based infusion sequence can be categorized according to the data used to set up the volume-based infusion sequence. The process of setting up a volume-based infusion sequence is described below.

[0055] Referring to Figure 14, the process by which a medication infusion device 10 according to one embodiment of the present invention sets up a volume-based infusion sequence will be described.

[0056] Drug injection device 10 can set a volume-based injection sequence using drug injection conditions, where the drug injection conditions include a drug injection amount. Drug injection device 10 can further include a communication module 300 for receiving the drug injection conditions from user terminal 40. The drug injection conditions are input by a user through user terminal 40, which is communicatively connected to drug injection device 10 via communication module 300. Controller 200 then sets a volume-based injection sequence corresponding to the drug injection conditions and transmits a corresponding control signal to drug injector 100.

[0057] Here, the volume-based injection sequence is not set using drug injection conditions, but may be selected directly by the user via the user terminal (40), or may be calculated and received via an external computing device based on the user's past drug injection device usage history.

[0058] The user terminal 40 may be embodied as a computer or a mobile terminal that can connect to the drug injection device 10 via wireless communication. Here, the computer may include, for example, a notebook computer, desktop computer, or laptop computer equipped with a web browser, and the mobile terminal may include, for example, any type of handheld-based wireless communication device, such as various smartphones, tablet PCs, or smart watches, which are wireless communication devices that ensure portability and mobility. The user terminal 40 is managed by the wearer of the drug injection device 10 or a medical professional, and drug injection conditions can be set through an application running on the user terminal 40.

[0059] Drug injection device (10) can also set a volume-based injection sequence using user input data. Here, the user input data includes the user's blood glucose level or the user's dietary information. The user input data is input by the user through user terminal (40) that is communicatively connected to drug injection device (10) via communication module (300), and control unit (200) calculates drug injection conditions based on the received user input data. Then, control unit (200) sets a volume-based injection sequence corresponding to the drug injection conditions and transmits a control signal corresponding to the volume-based injection sequence to drug injector (100).

[0060] Furthermore, drug injection device (10) can set a volume-based injection sequence using the user's biometric data. Here, the user's biometric data includes the user's blood glucose information. The user's biometric data is received through external measurement device (50) communicatively connected to drug injection device (10) via communication module (300), and control unit (200) calculates drug injection conditions based on the received user's biometric data. Then, it sets a volume-based injection sequence corresponding to the drug injection conditions and transmits a control signal corresponding to the volume-based injection sequence to drug injector (100). Here, external measurement device (50) may be a device that senses the user's blood glucose level.

[0061] Next, with reference to FIG. 15, the process by which the drug injection device sets up a volume-based injection sequence will be described.

[0062] The drug injection device 10 can set a volume-based injection sequence using the drug injection conditions. The drug injection device 10 can further include a user input / output interface module 400, through which the drug injection conditions are input by the user. In an embodiment in which the drug injection device 10 includes the user input / output interface module 400, the user can input the drug injection conditions, etc. directly into the user input / output interface module 400 without using a separate user terminal 40, thereby controlling the operation of the drug injection device 10. In such a case, the communication module 300 can be selectively omitted.

[0063] The control unit 200 sets a volume-based injection sequence corresponding to the drug injection conditions input through the user input / output interface module 400 and transmits a corresponding control signal to the drug injector 100. Here, the volume-based injection sequence may be directly selected by the user through the user interface module 400 without being set using the drug injection conditions.

[0064] The user input / output interface module (400) may include physical input / output buttons coupled to the external housing including the drug injection device (10) and a signal processing circuit that transmits signals generated by operation of the physical input / output buttons to the control unit (200).

[0065] Alternatively, the user input / output interface module (400) can output a UI that guides the user to input information for drug infusion conditions or volume-based infusion sequences through a touchscreen display.

[0066] Furthermore, in the process of setting the aforementioned volume-based injection sequence, the control unit (200) can also refer to a table in which multiple volume-based injection sequences are stored for each drug injection condition, and set a volume-based injection sequence corresponding to the drug injection condition.

[0067] FIG. 16 is a flow chart illustrating a drug injection method according to one embodiment of the present invention.

[0068] Referring to Figures 1, 2, and 16, a drug infusion method (S100) according to one embodiment of the present invention will be described. In the drug infusion method (S100), a volume-based infusion sequence for operating the drug infusion device (10) in an immediate infusion mode is set (step S110), and a control signal corresponding to the volume-based infusion sequence is applied to the electroosmotic pump (110) (step S120). In response to the control signal, the electroosmotic pump (110) then alternately generates negative and positive pressure for each pulse, thereby inhaling and expelling the drug and injecting the drug into the user (step S130). Here, the volume-based infusion sequence includes at least one pulse block that defines voltage or current pulses to be applied to the electroosmotic pump (110), and each pulse block defines a pair of pulse signals including a forward pulse and a reverse pulse that are applied to the electroosmotic pump (110) to alternately generate negative and positive pressure.

[0069] Each stage will be explained in detail below.

[0070] In the process of setting the volume-based injection sequence (step S110), the drug injection device 10 can set the volume-based injection sequence using drug injection conditions, and various embodiments can be implemented depending on when the drug injection conditions are input. Here, the drug injection conditions include the drug injection amount.

[0071] Drug injection device 10 can receive drug injection conditions input from a user via user terminal 40, which is communicatively connected to drug injection device 10 via communication module 300. Control unit 200 then sets a volume-based injection sequence corresponding to the drug injection conditions and transmits a corresponding control signal to drug injector 100. Here, the volume-based injection sequence can be directly selected by the user via user terminal 40, rather than being set using the drug injection conditions.

[0072] Furthermore, the drug injection device 10 can receive drug injection conditions input from the user using the user input / output interface module 400, and the control unit 200 sets a volume-based injection sequence corresponding to the drug injection conditions and transmits a control signal to the drug injector 100. Here, the volume-based injection sequence can also be directly selected by the user through the user interface module 400 without being set using the drug injection conditions.

[0073] Drug injection device (10) can also set a volume-based injection sequence using user input data. Here, the user input data includes the user's blood glucose level or the user's dietary information. The user input data is input by the user through user terminal (40) that is communicatively connected to drug injection device (10) via communication module (300). Control unit (200) calculates drug injection conditions based on the received user input data. Then, it sets a volume-based injection sequence corresponding to the drug injection conditions and transmits a control signal corresponding to the volume-based injection sequence to drug injector (100).

[0074] Furthermore, drug injection device (10) can set a volume-based injection sequence using the user's biometric data. Here, the user's biometric data includes the user's blood glucose information. The user's biometric data is received through external measurement device (50) communicatively connected to drug injection device (10) via communication module (300), and control unit (200) calculates drug injection conditions based on the received user's biometric data. Then, the control unit (200) sets a volume-based injection sequence corresponding to the drug injection conditions and transmits a control signal corresponding to the volume-based injection sequence to drug injector (100). Here, external measurement device (50) may be a device that senses the user's blood glucose level.

[0075] Meanwhile, in the process of setting a volume-based injection sequence, the control unit (200) can refer to a table in which multiple volume-based injection sequences are stored for each drug injection condition, and set a volume-based injection sequence corresponding to the drug injection condition.

[0076] FIG. 17 is a flow chart illustrating a process for applying the control signals shown in FIG. 16 to an electroosmotic pump.

[0077] Referring to FIG. 17, in the process of applying a control signal to the electroosmotic pump (step S120), if the drug injector (100) is operating in a basal infusion mode according to a preset rate-based infusion sequence, the control unit (200) temporarily suspends the output of the control signal corresponding to the rate-based infusion sequence (step S121) and outputs a control signal corresponding to the volume-based infusion sequence to the drug injector (100) (step S122).

[0078] The control signal corresponding to the volume-based injection sequence may include a voltage pulse pair including a forward voltage pulse and a reverse voltage pulse or a current pulse pair including a forward current pulse and a reverse current pulse in units of pulse blocks. Through such control signals, the electroosmotic pump can alternately generate negative and positive pressure for each pulse block, perform the operation of inhaling and expelling the drug, and inject the drug into the user in an immediate injection mode (step S130).

[0079] Thereafter, when the immediate injection mode is completed, the control unit 200 again outputs a control signal for the temporarily suspended rate-based injection sequence to the drug injector 100. Here, the control unit 200 omits the operations set for the rate-based injection sequence while the immediate injection mode is being performed, and outputs a control signal for the rate-based injection sequence set at the time when the operation of the immediate injection mode is completed.

[0080] A method according to an embodiment of the present invention may also be embodied in the form of a recording medium containing computer-executable commands, such as program modules executed by a computer. A computer-readable medium may be any available medium accessible by a computer, including both volatile and nonvolatile media, removable and non-removable media. A computer-readable medium may also include computer storage media. A computer storage medium includes both volatile and nonvolatile, removable and non-removable media embodied in any method or technology for storage of information, such as computer-readable commands, data structures, program modules, or other data.

[0081] Additionally, although the methods and systems of the present invention have been described in connection with particular embodiments, some or all of their components or operations may be implemented using a computer system having a general-purpose hardware architecture.

[0082] Those skilled in the art will understand that the present invention can be easily modified into other specific forms based on the above description without changing the technical idea or essential characteristics of the present invention. Therefore, the above-described embodiments should be understood to be illustrative in all respects and not limiting. The scope of the present invention is defined by the claims set forth below, and all modifications and variations derived from the meaning and scope of the claims and their equivalents should be construed as being within the scope of the present invention.

[0083] The scope of the present application is indicated by the claims that follow rather than by the above detailed description, and all modifications and variations that fall within the meaning and scope of the claims and their equivalents should be construed as being included within the scope of the present application.

Claims

1. In a drug injection device, A drug injector that electrochemically drives an electroosmotic pump to inhale a drug from a drug reservoir and then ejects the inhaled drug into an injection target; and a controller that outputs a control signal to the drug injector corresponding to a volume-based injection sequence that operates the electroosmotic pump in an immediate injection mode; The volume-based injection sequence comprises: at least one pulse block defining voltage or current pulses applied to the electroosmotic pump; each of the pulse blocks defines a pair of pulse signals to be applied to the electroosmotic pump, the pulse signals including a forward pulse and a reverse pulse that alternately generate negative and positive pressures; The electroosmotic pump alternately generates negative and positive pressure for each pulse block to draw in and expel the drug.

2. 10. The drug injection device of claim 1, The volume-based injection sequence comprises: A drug injection device in which M pulse blocks (M is a natural number equal to or smaller than N) selected from N pulse blocks (N is a natural number) that supply different amounts of drug are arranged, with the largest pulse block that satisfies the target drug injection amount being arranged preferentially.

3. 10. The drug injection device of claim 1, The volume-based injection sequence comprises: A drug infusion device, wherein when including a plurality of pulse blocks, the pulse blocks are arranged consecutively.

4. 10. The drug injection device of claim 1, A drug injection device in which the forward pulse and the reverse pulse included in the pair of pulse signals are set to have the same magnitude and duration so that the amount of drug inhaled and expelled by the electroosmotic pump is the same.

5. 10. The drug injection device of claim 1, The pair of pulse signals It consists of a voltage pulse pair including a forward voltage pulse and a reverse voltage pulse, and includes a stabilization pulse that maintains a 0V voltage for a predetermined time after the application of the forward voltage pulse and the reverse voltage pulse, or A drug injection device comprising a current pulse pair including a forward current pulse and a reverse current pulse, and including a stabilization pulse that maintains a 0 A current for a predetermined period of time after the application of the forward current pulse and the reverse current pulse.

6. 10. The drug injection device of claim 1, The control unit If the drug injector is operating in a basal infusion mode with a preset rate-based infusion sequence, suspending output of the control signal corresponding to the rate-based infusion sequence and outputting the control signal corresponding to the volume-based infusion sequence; The rate-based injection sequence comprises: A drug injection device comprising at least one pulse block that defines a voltage pulse or current pulse to be applied to the electroosmotic pump, and at least one rest block that maintains a 0 V voltage or 0 A current for a predetermined period of time after the application of the pulse block.

7. 7. The drug injection device of claim 6, The control unit The drug infusion device continues to output the control signal for the suspended rate-based infusion sequence upon completion of the immediate infusion mode operation according to the volume-based infusion sequence.

8. 7. The drug injection device of claim 6, The control unit when the immediate injection mode operation according to the volume-based injection sequence is completed, continue to output the control signal for the suspended rate-based injection sequence; A drug injection device that omits operations according to a scheduled rate-based injection sequence during the suspended period and performs operations according to the scheduled rate-based injection sequence upon completion of operations in the immediate injection mode.

9. 10. The drug injection device of claim 1, The electroosmotic pump comprises: a driving unit that is electrochemically driven by the control signal and alternately generates positive pressure and negative pressure; and The drug injection device further comprises a chamber that draws in a drug from a drug source in accordance with the pressure of the driving unit and then discharges the drug into the insertion portion.

10. 10. The drug injection device of claim 1, The drug injection device comprises: receiving drug infusion conditions from a user terminal or a user input / output interface module; The control unit The control signal is output using a volume-based injection sequence corresponding to the drug injection condition, A drug injection device, wherein the drug injection conditions include a drug injection amount.

11. 9. The drug injection device of claim 8, The drug injection device comprises: receiving user input data from a user terminal; The control unit A drug injection condition is calculated based on the user input data, and the control signal is output using a volume-based injection sequence corresponding to the drug injection condition. the user input data includes a user's blood glucose level, user activity information, or user diet information; A drug injection device, wherein the drug injection conditions include a drug injection amount.

12. 10. The drug injection device of claim 1, The drug injection device comprises: receiving biometric data of the user from an external measurement device; The control unit A drug injection condition is calculated based on the biometric data of the user, and the control signal is output using a volume-based injection sequence corresponding to the drug injection condition. the user's biometric data includes user's blood glucose information or user's activity information; A drug injection device, wherein the drug injection conditions include a drug injection amount.

13. 11. The drug injection device according to any one of claims 8 to 10, The control unit A drug infusion device that references a table in which a plurality of volume-based infusion sequences are stored for each drug infusion condition, and sets a volume-based infusion sequence corresponding to the drug infusion condition.

14. 10. The drug injection device of claim 1, The drug injection device comprises: receiving a volume-based injection sequence set by a user terminal or a user input / output interface module; The control unit A drug infusion device that utilizes the volume-based infusion sequence to output the control signal.

15. 10. The drug injection device of claim 1, The drug infusion device, wherein the volume-based infusion sequence is calculated and received via an external computing device based on a user's past drug infusion device usage history.

16. 1. A method for injecting a drug using a drug infusion device including an electroosmotic pump, comprising: setting up a volume-based infusion sequence that operates the drug infusion device in an immediate infusion mode; applying a control signal to the electroosmotic pump corresponding to the volume-based injection sequence; and In response to the control signal, the electroosmotic pump alternately generates negative and positive pressure for each pulse block to inhale and expel the drug, The volume-based injection sequence comprises: at least one pulse block defining voltage or current pulses applied to the electroosmotic pump; A drug injection method for a drug injection device, wherein each pulse block defines a pair of pulse signals including a forward pulse and a reverse pulse that are applied to the electroosmotic pump and generate alternating negative and positive pressures.

17. 17. The drug injection method for a drug injection device according to claim 16, Establishing the volume-based injection sequence includes: A drug injection method for a drug injection device in which M pulse blocks (M is a natural number smaller than or equal to N) selected from N pulse blocks (N is a natural number) that supply different amounts of drug are placed, with priority given to placing the largest pulse block that satisfies the target drug injection amount.

18. 17. The drug injection method for a drug injection device according to claim 16, Establishing the volume-based injection sequence includes: A drug injection method for a drug injection device, which adjusts the magnitude and duration of the pair of voltage pulse signals or the magnitude and duration of the pair of current signals, and sets the amount-based injection sequence so that the amount of drug inhaled and expelled by the pair of voltage pulse signals or the pair of current pulse signals is the same.

19. 17. The drug injection method for a drug injection device according to claim 16, The pair of pulse signals It consists of a voltage pulse pair including a forward voltage pulse and a reverse voltage pulse, and includes a stabilization pulse that maintains a 0V voltage for a predetermined time after the application of the forward voltage pulse and the reverse voltage pulse, or A drug injection method for a drug injection device, comprising a current pulse pair including a forward current pulse and a reverse current pulse, and including a stabilization pulse that maintains a 0 A current for a predetermined time after the application of the forward current pulse and the reverse current pulse.

20. 17. The drug injection method for a drug injection device according to claim 16, Establishing the volume-based injection sequence includes: the drug infusion device sets a volume-based infusion sequence corresponding to drug infusion conditions received from a user terminal or a user input / output interface module; A drug injection method for a drug injection device, wherein the drug injection conditions include a drug injection amount.

21. 17. The drug injection method for a drug injection device according to claim 16, Establishing the volume-based injection sequence includes: The drug injection device calculates the drug injection conditions based on user input data received from a user terminal, and sets a volume-based injection sequence corresponding to the drug injection conditions; The user input data includes a blood glucose level of the user and activity information of the user; A drug injection method for a drug injection device, wherein the drug injection conditions include a drug injection amount.

22. 17. The drug injection method for a drug injection device according to claim 16, Establishing the volume-based injection sequence includes: The drug injection device calculates the drug injection conditions based on the user's biometric data received from an external measurement device, and sets a volume-based injection sequence corresponding to the drug injection conditions; the user's biometric data includes user's blood glucose information or user's activity information; A drug injection method for a drug injection device, wherein the drug injection conditions include a drug injection amount.

23. 23. A drug injection method for a drug injection device according to any one of claims 20 to 22, Establishing the volume-based injection sequence includes: A drug injection method for a drug injection device, comprising: referencing a table in which a plurality of volume-based injection sequences are stored for each drug injection condition, and setting a volume-based injection sequence corresponding to the drug injection condition.

24. 17. The drug injection method for a drug injection device according to claim 16, Establishing the volume-based injection sequence includes: A drug infusion method for a drug infusion device, comprising receiving a volume-based infusion sequence set by a user terminal or a user input / output interface module, and setting the volume-based infusion sequence.

25. 17. The drug injection method for a drug injection device according to claim 16, Establishing the volume-based injection sequence includes: A drug injection method for a drug injection device, which receives a volume-based injection sequence calculated based on the user's past usage history of the drug injection device through an external computing device and sets the volume-based injection sequence.

26. 17. The drug injection method for a drug injection device according to claim 16, applying the control signal to the electroosmotic pump described If the drug injector is operating in a basal infusion mode with a preset rate-based infusion sequence, suspending output of control signals corresponding to the rate-based injection sequence; and outputting the control signal corresponding to the volume-based injection sequence; The rate-based injection sequence comprises: A drug injection method for a drug injection device, comprising at least one pulse block that defines a voltage pulse or current pulse to be applied to the electroosmotic pump, and at least one rest block that maintains a 0 V voltage or 0 A current for a predetermined period of time after the application of the pulse block.

27. 27. The drug injection method for a drug injection device according to claim 26, A drug injection method for a drug injection device, further comprising the step of continuing to output the control signal for the suspended rate-based injection sequence when the immediate injection mode according to the volume-based injection sequence is completed.

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