Drug infusion device and method of operating the drug infusion device

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 expel the aspirated drug into an infusion target, and a controller that outputs a control signal to the drug injector corresponding to a rate-based infusion sequence that drives the electroosmotic pump in a basal infusion mode. The rate-based infusion sequence includes at least one pulse block that defines a voltage pulse or current pulse to be applied to the electroosmotic pump, and at least one pause block that maintains a 0 V voltage or 0 A current for a predetermined time after application of the pulse block. Each pulse block defines a pair of pulse signals that are applied to the electroosmotic pump and include a forward pulse and a reverse pulse that alternately generate negative and positive pressures. The electroosmotic pump alternately generates negative and positive pressures for each pulse block to aspirate and expel the drug.

Description

Technical Field

[0001] The present invention relates to a drug injection device and Operation of the drug infusion device a method.

Background Art

[0002] Drugs can be injected into the body in various ways such as orally, subcutaneously, and intravenously depending on the type, treatment purpose, and method. A drug injector utilizing a drug pump can automatically inject a drug into the body at a desired speed and volume for a required time. Therefore, a drug injector utilizing a drug pump can be used not only in a hospital or in the daily life environment of a patient but also in various forms.

[0003] An insulin pump, generally called an insulin syringe, is for diabetic patients in whom insulin is not secreted or only a small amount is secreted, and is a medical device that plays a role like the pancreas that supplies insulin from the outside into the body accurately at a determined time to regulate blood glucose levels.

[0004] Such an insulin pump is used by insulin-dependent diabetic patients and can continuously inject a drug for 24 hours while being attached to the patient. Thus, since an insulin injector must inject a drug for a long period and regularly for diabetic patients, technologies for miniaturization and automation of the insulin injector have been actively developed for the convenience of users.

[0005] However, as the insulin injector is miniaturized and automated, there are cases where it is difficult to actually ensure the stability of the operation of the insulin injector, which is mainly due to back pressure caused by various reactions between the drug and biological fluids at the tip of the cannula or needle, which is the main cause of the occlusion phenomenon. In particular, when the amount of the drug to be injected is small or the injection is slow, the problem of such an occlusion phenomenon becomes more serious.

[0006] Therefore, a method is required to continuously inject drugs into the patient, while simultaneously injecting accurate amounts of drugs stably and controlling the drug injection to prevent blockage of the drug pathway during injection. [Overview of the project] [Problems that the invention aims to solve]

[0007] To solve the aforementioned problems, the present invention provides an electroosmotic pump-based drug infusion device for basal infusion of drugs. Device operation The technical challenge is to provide a method.

[0008] However, the technical challenges that this embodiment aims to address are not limited to those described above, and other technical challenges may exist. [Means for solving the problem]

[0009] As a technical means to solve the aforementioned technical problems, a drug injection device according to one embodiment of the present invention includes a drug injector that electrochemically drives an electroosmotic pump to draw in a drug from a drug storage unit and discharge the drawn drug to an injection target, and a control unit that outputs a control signal to the drug injector corresponding to a rate-based injection sequence that drives the electroosmotic pump in a basic injection mode, wherein the rate-based injection sequence includes at least one pulse block that makes a voltage pulse or current pulse applied to the electroosmotic pump and at least one pause block that maintains a 0V voltage or 0A current for a predetermined time after the application of the pulse block, wherein each pulse block defines a pair of pulse signals that are applied to the osmotic pump and include a forward pulse and a reverse pulse that alternately generate negative pressure and positive pressure, and the electroosmosis draws in and discharges the drug by alternately generating negative pressure and positive pressure for each pulse block.

[0010] Furthermore, a drug infusion method according to one embodiment of the present invention includes the steps of setting a speed-based infusion sequence to operate a drug infusion device in basic infusion mode, applying a control signal corresponding to the speed-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 in each pulse block to inhale and discharge a drug, wherein the speed-based infusion sequence includes at least one pulse block that defines a voltage pulse or current pulse applied to the electroosmotic pump and at least one pause block that maintains a 0V voltage or 0A current for a predetermined time after the application of the pulse block, 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 and alternately generate negative and positive pressure. [Effects of the Invention]

[0011] According to the aforementioned solution to the problem of the present invention, a rate-based injection sequence can be set for a drug injector utilizing an electroosmotic pump, according to the drug injection conditions, and the drug injector can be controlled to inject a fixed amount of drug. [Brief explanation of the drawing]

[0012] [Figure 1] This is a schematic block diagram showing a drug injection device according to one embodiment of the present invention. [Figure 2] Figure 1 is a block diagram illustrating the schematic configuration of the drug injector. [Figure 3] This is a conceptual diagram illustrating a velocity-based injection sequence according to one embodiment of the present invention. [Figure 4] This table shows examples of multiple velocity-based injection sequences according to one embodiment of the present invention. [Figure 5] This table shows examples of multiple pulse blocks according to one embodiment of the present invention. [Figure 6] This table shows an example of the drug infusion period according to one embodiment of the present invention. [Figure 7]This is an illustrative diagram showing the signal structure for a velocity-based injection sequence according to one embodiment of the present invention. [Figure 8] Figure 2 is a block diagram illustrating the schematic configuration of the electroosmotic pump shown. [Figure 9] Figure 8 is a block diagram that schematically shows the configuration of the drive unit. [Figure 10] Figure 9 is an illustrative diagram illustrating the schematic configuration of the drive unit shown. [Figure 11] This is an example diagram illustrating the application of a drug injection device according to one embodiment of the present invention. [Figure 12] Figure 11 is a block diagram illustrating the schematic configuration of the drug injection device shown. [Figure 13] Figure 11 is a block diagram illustrating the schematic configuration of the drug injection device shown. [Figure 14] This is a flowchart illustrating a drug injection method according to one embodiment of the present invention. [Modes for carrying out the invention]

[0013] The present invention will be described in detail below with reference to the accompanying drawings. However, the present invention can be carried out in various different forms and is not limited to the embodiments described herein. Furthermore, the accompanying drawings are merely for the purpose of facilitating the understanding of the embodiments disclosed herein and do not limit the technical ideas disclosed herein. In order to clearly illustrate the present invention with the drawings, parts that are not relevant to the description have been omitted, and the size, form, and shape of each component shown in the drawings can be varied in various ways. Parts that are the same or similar throughout the specification are denoted by the same or similar reference numerals.

[0014] Suffixes such as "module" and "section" for the components used in the following description are given or mixed only for the ease of preparing the specification, and do not have meanings or roles that are distinguishable from each other per se. Also, when explaining the embodiments disclosed in this specification, if it is determined that a specific description of related known technologies may obscure the gist of the embodiments disclosed in this specification, the detailed description thereof is omitted.

[0015] Throughout the specification, when a part is "connected (connected, contacted or coupled)" to another part, it includes not only the case where it is "directly connected (connected, contacted or coupled)", but also the case where it is "indirectly connected (connected, contacted or coupled)" with another member interposed therebetween. Also, when a part "includes (comprises or has)" a certain component, it means that other components can be further "included (comprises or has)" without excluding other components unless otherwise stated.

[0016] Terms representing ordinal numbers such as the first, second, etc. used in this specification are only used for the purpose of distinguishing a certain component from other components, and do not limit the order or relationship of the components. For example, the first component of the present invention may be named the second component, and similarly, the second component may also be named the first component.

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

[0018] Referring to FIGS. 1 and 2, a drug injection device (10) according to an 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 basal infusion mode to draw drug from the drug storage unit and discharges the drawn drug to the target of injection. The control unit (200) then outputs a control signal to the drug injector (100) corresponding to a rate-based infusion sequence that drives the electroosmotic pump (110) in basal infusion mode. Here, basal infusion mode is a drug infusion mode in which drug is injected into the user for a certain period of time in order to maintain the user's blood glucose level at a constant level.

[0020] The control unit (200) can mean a data processing device embedded in hardware, having a physically structured circuit for performing functions expressed by code or commands contained within a program. Examples of such data processing devices embedded in hardware include microprocessors, central processing units (CPUs), processor cores, multiprocessors, ASICs (application-specific integrated circuits), FPGAs (field programmable gate arrays), MCUs (Micro Controller Units), and embedded processors, but the scope of the present invention is not limited thereto.

[0021] On the other hand, the control unit (200) can be implemented not only as a standalone unit built into the drug infusion device (10), but also in a configuration where it is connected to a user terminal (40), described later, via a communication module, and the user terminal (40) and the control unit (200) are integrated to control the basic infusion mode of the drug infusion device (10).

[0022] Figure 3 is a diagram illustrating the concept of a velocity-based injection sequence according to one embodiment of the present invention, and Figures 4 to 7 are illustrative diagrams showing a velocity-based injection sequence according to one embodiment of the present invention. Below, the velocity-based injection sequence will be described in detail with reference to Figures 3 to 7.

[0023] A rate-based infusion sequence is configured by arranging multiple pulse blocks (20) that satisfy the drug infusion rate, depending on drug conditions including the drug infusion period and drug infusion rate. In this case, the rate-based infusion sequence is configured by arranging multiple pulse blocks that satisfy the drug infusion rate in a unit time (e.g., 1 hour or 30 minutes) and repeating this during the drug infusion period.

[0024] Referring to Figure 3(a), the rate-based infusion sequence consists of multiple pulse blocks (20) and multiple pause blocks (30), but it starts with the pulse blocks (20), and the pause blocks (30) are placed after the pulse blocks (20). The pulse blocks (20) define the voltage pulse or current pulse applied to the electroosmotic pump (110), and the amount of drug injected varies depending on the duration. The pause blocks (30) maintain a 0V voltage or 0A current for a predetermined time after the application of the pulse blocks (20).

[0025] To satisfy drug infusion conditions, including drug infusion duration and drug infusion rate, the rate-based infusion sequence is set as follows: First, to satisfy the drug infusion rate, pulse blocks must be arranged that satisfy the drug infusion amount per unit time. In this invention, various pulse blocks can be set via the electroosmotic pump (110). However, during the drug infusion period, if possible, a large or preset number of pulse blocks should be arranged so that the pause period of the pause block placed after each pulse block is as short as possible, preventing the drug from drying out or occlusion from occurring. To satisfy these conditions, the rate-based infusion sequence may be set as follows:

[0026] A rate-based infusion sequence consists of M pulse blocks (20) selected from N pulse blocks (20) (where N is a natural number) that supply different amounts of drug, according to the drug infusion rate per unit time. The multiple pulse blocks (20) and pause blocks (30) constituting the rate-based infusion sequence are composed of combinations where the duration of each pause block (30) is less than the recommended pause period and satisfies the drug infusion rate. Here, the number of pulse blocks (20) constituting the rate-based infusion sequence is a number predetermined according to the unit time, or the maximum number that can represent the drug infusion rate.

[0027] The sum of the durations of the multiple pulse blocks (20) and the multiple pause blocks (30) placed after the pulse blocks (20) in the rate-based infusion sequence is set to correspond to a unit of time, and the arrangement of the pulse blocks (20) is such that the pulse block (20) that delivers the largest amount of drug among the pulse blocks (20) is output first, although the arrangement of subsequent pulse blocks (20) may vary by selection.

[0028] Furthermore, the M pulse blocks (20) constituting the rate-based infusion sequence may also be configured such that the duration of the pause block (30) placed after each pulse block (20) is less than the recommended pause period, while satisfying the drug infusion rate of the drug infusion conditions, and the total number of uses for each selected pulse block (20) is a preset number or a maximum number.

[0029] Figure 4 is a table illustrating examples of multiple rate-based infusion sequences, and Figure 5 is a table illustrating examples of N pulse blocks (30) infusing different amounts of drug. The rate-based infusion sequences will be explained with examples, referring to Figures 4 and 5.

[0030] The multiple rate-based infusion sequences shown in Figure 4 are set at different drug infusion rates. A rate-based infusion sequence consists of a combination of M pulse blocks (20) from among N pulse blocks (20) that supply different amounts of drug, as shown in Figure 5, which can be set so that the duration of each pause block (30) is less than the recommended pause period while satisfying the drug infusion rate. Each rate-based infusion sequence is arranged so that the pulse block (20) that supplies the largest amount of drug among the pulse blocks (20) that make up the rate-based infusion sequence is output first.

[0031] Here, the rate-based infusion sequence is configured so that 12 pulse blocks (20) can be placed, and consists of combinations of pulse blocks (20) that can be placed to satisfy the drug infusion rate. For example, a rate-based infusion sequence with a drug infusion rate of 0.7 U / hr consists of a combination of two pulse blocks (20) that supply 0.5 μL and 1 μL, of which the pulse block (20) that supplies 1 μL is placed first. The total number of times each of the pulse blocks (20) that supply 0.5 μL and 1 μL is used is a number predetermined by 12. Here, in Figure 4, the drug infusion amount of the rate-based infusion sequence is expressed in U units, and in Figure 5, the drug infusion amount of the pulse block (20) is expressed in μ units, but 1 U is the same amount as 10 U. Therefore, 0.35 U is the same amount as 3.5 μ.

[0032] Although not shown in the table, a pause block (30) is always placed after the pulse block (20), and to prevent closure, the duration of the pause block (30) is set to less than the recommended duration. The duration of the pause block (30) is set differently depending on the duration of the pulse block (20) placed immediately before it.

[0033] To illustrate the process of setting the duration of a pause block (30), in Figure 4, each velocity-based injection sequence has a structure in which 12 pulse blocks (20) are arranged. Therefore, the duration of one pulse block (20) and one pause block (30) is set to 300 seconds (3600 seconds / 12). For example, the duration of a pause block (30) placed after a pulse block (20) that injects 0.5 μL would be 300 seconds minus the duration of the pulse block (20) that injects 0.5 μL. Referring to Figure 5, the duration of the pulse block (20) that injects 0.5 μL is 5.4 seconds, which is the sum of the duration of the forward pulse and the duration of the reverse pulse. Therefore, the duration of the pause block (30) is set to 300 seconds - 5.4 seconds, which is 294.6 seconds.

[0034] Furthermore, in rate-based infusion sequences, there may be cases where there are no combinations of pulse blocks (20) that satisfy a preset number. The number may be less than or more than the preset number. For example, in Figure 4, a rate-based infusion sequence with a drug infusion rate of 0.35 U / hr to 0.55 U / hr consists of fewer than 12 pulse blocks (20). In such cases, the pulse blocks (20) are configured to the maximum number possible, less than the preset number, to satisfy the drug infusion rate. Also, in the case of a rate-based infusion sequence with a rate of 3.45 U / hr, there are 13 pulse blocks (20), which is more than 12. In such cases, the structure of the rate-based infusion sequence is reconfigured to accommodate 13 pulse blocks (20) per hour, and pulse blocks (20) and pause blocks (20) may be arranged.

[0035] Furthermore, while Figure 4 shows an example of a velocity-based injection sequence structure with a unit time set to 1 hour, it is not limited to this, and the number and structure of pulse blocks (20) constituting the velocity-based injection sequence may differ depending on the set unit time.

[0036] Such rate-based infusion sequences are arranged sequentially during a drug infusion period. Specifically, a drug infusion period can be divided into at least one segment, each segment containing information about its duration and the drug infusion rate during that duration. Each segment can be configured by repeatedly arranging a rate-based infusion sequence set for a unit time to satisfy the drug infusion rate during its duration. Here, the duration and drug infusion rate of each segment can be set by the user.

[0037] Referring to Figure 6, an example of a drug infusion period consisting of a rate-based infusion sequence will be explained. Figure 6 shows a drug infusion period set to 24 hours, which is divided into multiple segments with predetermined time zones. The structure of the first segment will be described as follows: the first segment is a 2-hour interval in which the drug is infused at a rate of 0.7 U / hour, and consists of two rate-based infusion sequences with the drug infusion rate of 0.7 U / hour shown in Figure 4, arranged consecutively. Here, each segment is set in units of 1 hour, but is not limited to this, and can be divided by a predetermined unit of time.

[0038] Next, referring to Figure 3(b) and Figure 7, the pulse blocks (20) are described as follows: Each pulse block (30) contains information about a pair of pulse signals, including a forward pulse and a reverse pulse, and includes information about the magnitude of each pulse and the duration for which the pulse is maintained. The pair of pulse signals, including the forward pulse and the reverse pulse, are applied to the electroosmotic pump (110), which alternately generates negative and positive pressure. This alternates between negative and positive pressure for each pulse block (20), causing the drug to be inhaled and discharged.

[0039] The pair of pulse signals (21, 22) included in the pulse block (30) are either voltage pulse signals or current pulse signals. The pair of voltage pulse signals may consist of a forward voltage pulse and a reverse voltage pulse, and the pair of current pulse signals may consist of a forward current pulse and a reverse current pulse. Here, the pair of voltage pulse signals may include information about the magnitude and duration of each voltage pulse, and the pair of current pulse signals may include information about the magnitude and duration of each current pulse. For example, in the velocity-based injection sequence shown in Figure 7, the magnitude of the pulse signal may be 2V and the holding time may be 10s.

[0040] Each pulse block (20) included in the velocity-based injection sequence may contain voltage pulses with different voltage magnitudes or current pulses with different current magnitudes. Alternatively, each pulse block (20) may contain pulses with the same voltage magnitude or current pulses with the same current magnitude, but with different durations.

[0041] Furthermore, the forward pulse (21) and reverse pulse (22) contained in the pulse block (20) are set to have the same magnitude and duration, so that the amount of drug inhaled and discharged by the electroosmotic pump (110) can be kept equal.

[0042] Furthermore, the pair of pulse signals (21, 22) included in the pulse block (20) may be supplied with a constant voltage or constant current, and the amount of drug inhaled and dispensed by each pulse block may be adjusted by adjusting the duration of the pulse signals supplied with a constant voltage or constant current. For example, the pulse block (20) in Figure 7 is supplied with a constant voltage of 2V.

[0043] Furthermore, the pair of pulse signals (21, 22) can be adjusted in both magnitude and duration, so that the amount of inhaled drug and the amount of drug dispensed are equal. For example, the magnitude of the forward voltage pulse can be set to 2V and the duration to 10s, and the magnitude of the consecutive reverse voltage pulse can be set to 1V and the duration to 20s, and the area of ​​the forward pulse and the area of ​​the reverse pulse can be set to be the same to maintain the amount of inhaled drug and the amount of drug dispensed being equal.

[0044] Each pulse block (20) may further include a stabilization pulse (23), which is a pulse that maintains a 0V voltage for a predetermined time after the application of a forward voltage pulse (21) and a reverse voltage pulse (22). The stabilization pulse (23) can stabilize the operation of the electroosmosis pump (110). Here, if the pulse block (20) of the rate-based injection sequence consists of a pair of current pulses, the pulse block (20) may further include a stabilization pulse (23) that maintains a 0A current for a predetermined time after the application of a forward current pulse and a reverse current pulse.

[0045] Next, the pause block (30) is placed after the pulse block (20) is applied and is a signal in which a 0V voltage or 0A current is maintained for a predetermined time. The drug infusion device (10) of the present invention injects a drug amount equal to the drug injection amount into the user in a fixed amount of time. Therefore, the pause block (30) included in the rate-based injection sequence can control the time over which the target drug injection amount is injected, and by adjusting the time during which no drug is injected to the minimum, it is possible to prevent the flow path of the drug injector (100) from becoming clogged during periods when no drug is injected.

[0046] The control unit (200) generates a control signal consisting of a voltage pulse or current pulse, etc., corresponding to the velocity-based injection sequence, based on the information of the pulse block (20) included in the velocity-based injection sequence, and applies it to the drug injector (100).

[0047] When a control signal corresponding to such a rate-based infusion sequence is applied to the electroosmotic pump (110), the electroosmotic pump (110) alternately generates negative and positive pressure for each pulse block, inhaling and discharging the drug. Here, the control signal may consist 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, in units of pulse blocks (20).

[0048] Figure 8 is a schematic block diagram showing the configuration of the electroosmotic pump shown in Figure 2.

[0049] Referring to Figure 8, the electroosmotic pump (110) will be described in detail. The electroosmotic pump (110) includes a drive unit (111) and a chamber (112). The drive unit (111) is electrochemically driven by a control signal to generate positive and negative pressure, and dispenses the drug according to the positive and negative pressure. The chamber (112) draws the drug from the drug storage unit (120) according to the pressure of the drive unit (111), and then dispenses the drug into the insertion unit (130). Here, the drug is a drug that must be injected into a specific patient, and insulin injected into a diabetic patient can be given as an example.

[0050] Figure 9 is a block diagram schematically showing the configuration of the drive unit shown in Figure 8, and Figure 10 is an illustrative diagram schematically showing the configuration of the drive unit shown in Figure 9.

[0051] Referring specifically to Figures 9 and 10, the drive 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, thereby causing fluid to move. The drive unit (111) may include the membrane (111a), a power supply (111d) that applies voltage or current to the first electrode (111b) and the second electrode (111c) positioned on both sides of the membrane (111a), and a flow path for the fluid to move.

[0052] Furthermore, the drive unit (111) may include a first diaphragm (111e) positioned adjacent to the first electrode (111b) and a second diaphragm (111f) positioned adjacent to the second electrode (111c). Each diaphragm (111e, 111f) is provided on one side and the other side of the membrane (111a), and its shape is deformed by the movement of the pumping solution as positive and negative pressures are alternately generated. Exemplarily, the first diaphragm (111e) and the second diaphragm (111f) transmit the negative and positive pressures generated by the drive of the membrane (111a) to the fluid to be transferred. More specifically, when negative pressure is generated, at least a portion of the first diaphragm (111e) and the second diaphragm (111f) are retracted (moving in the direction of circled number 1), and the fluid to be transferred is drawn into the chamber (112). Conversely, when positive pressure is generated, at least a portion of the first diaphragm (111e) and the second diaphragm (111f) are advanced (moving in the direction of circled number 2), and the fluid to be transferred is discharged from the chamber (112).

[0053] Generally, silica and glass are used as materials for the porous membrane (111a), and when these are placed in an aqueous solution, their surfaces become negatively charged. The porous membrane (111a) has many pathways through which fluids can pass, and if one of these pathways is magnified, the negatively charged fluid surface can be balanced by mobile cations with a positive charge that can move. In this state, when a positive voltage is applied to the first electrode (111b) and a negative voltage to the second electrode (111c), a negative pressure is generated, and this negative pressure causes the fluid inside the drive unit (111) to move in the direction of the circled number 1. At this time, the drug is inhaled through the inhalation passage (141) and flows into the chamber (112) via the inhalation valve (140). At this time, the discharge valve (150) is closed to prevent negative pressure from being transmitted to the discharge passage (151). Conversely, when a negative voltage is applied to the first electrode (111b) and a positive voltage to the second electrode (111c), a reversible electrochemical reaction generates positive pressure in the opposite direction. This positive pressure causes the fluid inside the drive unit (111) to move in the direction of the circled number 2. At this time, the drug stored in the chamber (112) flows into the target object through the discharge valve (150) and the discharge passage (151). At this time, the inhalation valve (140) is shut off to prevent positive pressure from being transmitted to the inhalation passage (141).

[0054] This phenomenon is called electroosmosis, and a pump that utilizes this principle is called an electroosmotic pump (110).

[0055] The electrodes used in the drive unit (111) may be provided in the form of porous electrodes such as platinum mesh (Pt mesh), porous carbon paper or carbon cloth, or various electrode materials coated on a porous structure, in order to facilitate the movement of fluid.

[0056] Furthermore, the electrodes used in the drive unit (111) can also be realized in the form of being coated with various fixable materials such as drop coating and spin coating applied to an impermeable substrate. In this case, the impermeable substrate is a plate-shaped substrate containing at least one of conductive materials, semiconductor materials, and nonconductive materials, and the electrode material coated thereon may consist of metal, metal oxide, conductive polymer, metal hexacyanoferrate, carbon nanostructure, or a composite thereof.

[0057] The drive unit (111) alternately supplies voltage or current polarity to the first electrode (111b) and the second electrode (111c), thereby reversibly generating forward and reverse electrochemical reactions. As the forward and reverse electrochemical reactions repeatedly occur, the fluid inside the electroosmotic pump repeatedly performs reciprocating motion. Furthermore, the fluid in the first electrode (111b) and the second electrode (111c) is repeatedly consumed and regenerated due to the repeated forward and reverse reversible electrochemical reactions. When an inhalation valve (140) and a discharge valve (150) are connected to the chamber (112) of such an electroosmotic pump (110), the drug in the drug storage unit (120) is drawn in through the inhalation passage (141) during the inhalation operation and stored in the chamber (112) via the inhalation valve (140). Then, during the dispensing operation, the drug stored in the chamber (112) is dispensed through the dispensing valve (150) and the dispensing passage (151) to the insertion section (130).

[0058] Therefore, the magnitude and duration of the voltage or current applied to the first and second electrodes (111b, 111c) can be controlled to control the pressure generated by the electroosmotic pump (110) and the volume of drug discharged.

[0059] Figure 11 is an example diagram illustrating the application of a drug infusion device according to one embodiment of the present invention, Figure 12 is a schematic block diagram showing the configuration of the drug infusion device shown in Figure 11, and Figure 13 is a schematic block diagram showing the configuration of the drug infusion device shown in Figure 11. The operation of the drug infusion device (10) will be specifically described with reference to Figures 11 to 13.

[0060] The drug infusion device (10) receives predetermined information from the user and sets a rate-based infusion sequence based on this information. The process of setting the rate-based infusion sequence can be divided into different parts depending on the data used to set the rate-based infusion sequence. The process of setting the rate-based infusion sequence will be described below.

[0061] Referring to Figure 12, the process by which a drug infusion device (10) according to one embodiment of the present invention sets a rate-based infusion sequence will be described.

[0062] The drug infusion device (10) can set a rate-based infusion sequence using drug infusion conditions. Here, the drug infusion conditions include the drug infusion period and the drug infusion rate. The user can input drug infusion conditions by dividing the drug infusion period into multiple segments having predetermined durations and setting a drug infusion rate for each segment. Then, the drug infusion device (10) sets a rate-based infusion sequence for the conditions set for each segment.

[0063] The drug infusion device (10) may further include a communication module (300) for receiving drug infusion conditions from a user terminal (40). The drug infusion conditions are input from the user via the user terminal (40), which is connected to the drug infusion device (10) via the communication module (300). The control unit (200) then sets a rate-based infusion sequence corresponding to the drug infusion conditions and transmits a control signal to the drug injector (100). Here, the rate-based infusion sequence may not be set using the drug infusion conditions, but may be directly selected by the user via the user terminal (40), or calculated and received via an external computing device based on the user's past usage history of drug infusion devices.

[0064] The user terminal (40) can be a computer or mobile device that can connect to the drug infusion device (10) via wireless communication. Here, the computer includes, for example, a laptop, desktop, or laptop computer equipped with a web browser, and the mobile device can include, for example, any type of handheld wireless communication device that ensures portability and mobility, such as various smartphones, tablet PCs, or smartwatches. Such a user terminal (40) is managed by the wearer of the drug infusion device (10) or a medical professional, and drug infusion conditions can be set through an application running on the user terminal (40).

[0065] Furthermore, the drug infusion device (10) can set a rate-based infusion 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 from the user via a user terminal (40) which is communicated with the drug infusion device (10) via a communication module (300), and the control unit (200) calculates the drug infusion conditions based on the received user input data. Then, it sets a rate-based infusion sequence corresponding to the drug infusion conditions and transmits a control signal corresponding to the rate-based infusion sequence to the drug injector (100).

[0066] Furthermore, the drug infusion device (10) can set a rate-based infusion 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 by an external measuring device (50) which is connected to the drug infusion device (10) via a communication module (300), and the control unit (200) calculates the drug infusion conditions based on the received user's biometric data. Then, it sets a rate-based infusion sequence corresponding to the drug infusion conditions and transmits a control signal corresponding to the rate-based infusion sequence to the drug injector (100). Here, the external measuring device (50) may be a device that senses the user's blood glucose level.

[0067] Next, with reference to Figure 13, we will describe the process by which the drug infusion device sets up a rate-based infusion sequence.

[0068] The drug infusion device (10) can set a rate-based infusion sequence using drug infusion conditions. The drug infusion device (10) may further include a user input / output interface module (400), through which the user can input drug infusion conditions. In embodiments in which the drug infusion device (10) includes a user input / output interface module (400), the user can directly input drug infusion conditions and the like into the user input / output interface module (400) to control the operation of the drug infusion device (10) without using a separate user terminal (40). In such cases, the communication module (300) may be selectively excluded.

[0069] The control unit (200) sets an infusion sequence corresponding to the drug infusion conditions input through the user input / output interface module (400) and transmits a corresponding control signal to the drug injector (100). Here, the rate-based infusion sequence is not set using the drug infusion conditions, but can also be directly selected by the user through the user input / output interface module (400).

[0070] The user input / output interface module (400) may include physical input / output buttons coupled to an external housing including a drug injection device (10), and a signal processing circuit that transmits signals generated by the operation of the physical input / output buttons to a control unit (200).

[0071] Alternatively, the user input / output interface module (400) can output a UI that guides the user to input information about drug infusion conditions or rate-based infusion sequences via a touchscreen display.

[0072] Furthermore, in the process of setting the rate-based infusion sequence as described above, the control unit (200) can also refer to a table in which multiple rate-based infusion sequences are stored for each drug infusion condition and set a rate-based infusion sequence corresponding to the drug infusion condition.

[0073] Figure 14 is a flowchart illustrating a drug injection method according to one embodiment of the present invention.

[0074] Referring to Figures 1, 2, and 14, a drug infusion method (S100) according to one embodiment of the present invention is described as follows: The drug infusion method (S100) sets a rate-based infusion sequence to operate the drug infusion device (10) in basic infusion mode (step S110), and applies a control signal corresponding to the rate-based infusion sequence to the electroosmotic pump (step S110) (step S120). Subsequently, in response to the control signal, the electroosmotic pump (110) alternately generates negative and positive pressure in each pulse block to inhale and discharge the drug, injecting the drug into the user (step S130). Here, the rate-based infusion sequence includes at least one pulse block that defines a voltage pulse or current pulse applied to the electroosmotic pump (110), and at least one pause block that maintains a 0V voltage or 0A current for a predetermined time after the application of the pulse block, 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 to alternately generate negative and positive pressure.

[0075] The following sections will explain each stage in detail.

[0076] In the process of setting a rate-based injection sequence (step S110), the drug infusion device (10) can set a rate-based injection sequence using drug infusion conditions, and can have various embodiments depending on the drug infusion conditions input. Here, the drug infusion conditions include drug infusion period and drug infusion rate, or drug infusion volume and drug infusion period.

[0077] The drug infusion device (10) can receive drug infusion conditions from a user via a user terminal (40) which is connected to the drug infusion device (10) through a communication module (300). The control unit (200) then sets a rate-based infusion sequence corresponding to the drug infusion conditions and transmits a corresponding control signal to the drug injector (100). Here, the rate-based infusion sequence is not set using the drug infusion conditions, but can also be directly selected by the user via the user terminal (40).

[0078] Furthermore, the drug infusion device (10) can receive drug infusion conditions from the user using a user input / output interface module (400), and the control unit (200) sets a rate-based infusion sequence corresponding to the drug infusion conditions and transmits a control signal to the drug injector (100). Here, the rate-based infusion sequence is not set using the drug infusion conditions, but can also be directly selected by the user through the user input / output interface module (400).

[0079] Furthermore, the drug infusion device (10) can set a rate-based infusion 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 received from the user via a user terminal (40) which is connected to the drug infusion device (10) via a communication module (300), and the control unit (200) calculates the drug infusion conditions based on the received user input data. Then, it sets a rate-based infusion sequence corresponding to the drug infusion conditions and transmits a control signal corresponding to the rate-based infusion sequence to the drug injector (100).

[0080] Furthermore, the drug infusion device (10) can set a rate-based infusion sequence using the user's biometric data. Here, the user's biometric data includes the user's blood glucose information. The control unit (200) receives the user's biometric data through an external measuring device (50) which is connected to the drug infusion device (10) via a communication module (300), and calculates the drug infusion conditions based on the received user's biometric data. It then sets a rate-based infusion sequence corresponding to the drug infusion conditions and transmits a control signal corresponding to the rate-based infusion sequence to the drug injector (100). Here, the external measuring device (50) may be a device that senses the user's blood glucose level.

[0081] On the other hand, in the process of setting a rate-based infusion sequence, the control unit (200) can refer to a table in which multiple rate-based infusion sequences are stored for each drug infusion condition and set a rate-based infusion sequence corresponding to the drug infusion condition.

[0082] Then, in the process of applying the control signal to the electroosmotic pump (step S120), the control signal corresponding to the rate-based injection sequence may include a pair of voltage pulses containing a forward voltage pulse and a reverse voltage pulse, or a pair of current pulses containing a forward current pulse and a reverse current pulse, through such a control signal, the electroosmotic pump can perform the operation of alternately generating negative and positive pressure for each pulse block, inhaling and discharging (step S130), and injecting the drug into the user.

[0083] A method according to one embodiment of the present invention may be embodied in the form of a recording medium containing a command that can be executed by a computer, such as a program module executed by a computer. The computer-readable medium may be any available medium accessible by a computer, and includes all volatile and non-volatile media, removable and non-removable media. The computer-readable medium may also include computer storage media. Computer storage media include all volatile and non-volatile, removable and non-removable media embodied by any method or technique for storing information such as computer-readable commands, data structures, program modules, or other data.

[0084] Furthermore, although the methods and systems of the present invention have been described in relation to specific embodiments, some or all of their components or operations can be embodied using a computer system having a general-purpose hardware architecture.

[0085] A person with ordinary skill in the art to which the present invention pertains will understand, based on the above description, that the invention can be readily modified into other specific forms without altering the technical idea or essential features of the invention. Therefore, the embodiments described above should be understood to be illustrative and not limiting in all respects. The scope of the present invention is defined by the claims described below, and all modified or altered forms derived from the meaning and scope of the claims and the concept of equivalents thereto should be interpreted as being included within the scope of the present invention.

[0086] The scope of this application is defined by the claims, which are described below rather than by the detailed description above, and all modified or altered forms derived from the meaning and scope of the claims and the concept of equivalents thereof should be interpreted as being included within the scope of this application.

Claims

1. In a drug infusion device, A drug injector that electrochemically drives an electroosmotic pump to draw in a drug from a drug storage unit and discharges the drawn drug to the target of injection, and The control unit includes a control unit that outputs a control signal to the drug injector corresponding to a rate-based infusion sequence that drives the electroosmotic pump in basal infusion mode, The velocity-based injection sequence is A plurality of pulse blocks of different types that define voltage pulses or current pulses applied to the electroosmotic pump and supply different amounts of drug, comprising a plurality of pulse blocks arranged to satisfy the drug infusion rate according to drug infusion conditions including drug infusion period and drug infusion rate, and a plurality of pause blocks that maintain a 0V voltage or 0A current for a predetermined time after the application of each pulse block, Each of the pulse blocks defines a pair of pulse signals, each including a forward pulse and a reverse pulse, which are applied to the electroosmotic pump and alternately generate negative and positive pressure. The electroosmotic pump is a drug infusion device that alternately generates negative and positive pressure for each pulse block, thereby drawing in and discharging the drug.

2. In the drug injection device according to claim 1, A drug infusion device, wherein the sum of the durations of the plurality of pulse blocks and the durations of the plurality of pause blocks arranged after the pulse blocks is set to correspond to the drug infusion period.

3. In the drug injection device according to claim 1, The velocity-based injection sequence is The plurality of pulse blocks and the plurality of pause blocks are arranged for a unit of time, The control unit, A drug infusion device that repeatedly provides the rate-based infusion sequence during the drug infusion period.

4. In the drug injection device according to claim 2, The velocity-based injection sequence is A drug infusion device in which the duration of each of the aforementioned pause blocks is set to be less than the recommended pause period.

5. In the drug injection device according to claim 2, The velocity-based injection sequence is A drug infusion device in which, among the aforementioned multiple pulse blocks, the pulse block that maximizes the amount of drug to be supplied is output first.

6. In the drug injection device according to claim 1, The velocity-based injection sequence is From among N types of pulse blocks (where N is a natural number) that supply different amounts of drug, M types of pulse blocks (M being less than or equal to N, a natural number) are selected according to the drug injection conditions. A drug infusion device in which the duration of the selected M types of pulse blocks and the sum of the durations of the plurality of pause blocks placed after each pulse block are set to correspond to the drug infusion period.

7. In the drug infusion device according to claim 6, In the aforementioned velocity-based injection sequence, A drug infusion device in which the M-type pulse blocks satisfy the drug infusion rate of the drug infusion conditions, the total number of uses for each selected pulse block is set to a preset number or the maximum number, and the duration of the pause block placed after each pulse block is set to be less than the recommended pause period.

8. In the drug injection device according to claim 2, The velocity-based injection sequence is A drug infusion device in which the arrangement of pulse blocks and pause blocks assigned to each segment is set such that, according to segments obtained by dividing the drug infusion period into predetermined time units, the drug infusion rate is the same for some segments and different for other segments.

9. In the drug injection device according to claim 1, One pulse block and one pause block are formed into one group, The duration of the aforementioned group is set to the first hour. The duration of the aforementioned pause block is: A drug infusion device, which is set to a second time obtained by subtracting the duration of the pulse block from the first time.

10. In the drug injection device according to claim 1, The pair of pulse signals are 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 or the reverse voltage pulse, A drug infusion device comprising a pair of current pulses including a forward current pulse and a reverse current pulse, and including a stabilization pulse that maintains a 0A current for a predetermined time after the application of the forward current pulse or the reverse current pulse.

11. In the drug injection device according to claim 1, The aforementioned electroosmotic pump is A drive unit that is electrochemically driven by the aforementioned control signal and alternately generates positive and negative pressure, and A drug injection device comprising a chamber that inhales a drug from the drug storage section in response to the pressure of the drive section, and then discharges the drug into the insertion section.

12. In the drug injection device according to claim 1, The drug injection device is The drug infusion conditions are received from the user terminal or user input / output interface module. The control unit, A drug infusion device that outputs the control signal using the rate-based infusion sequence corresponding to the drug infusion conditions.

13. In the drug injection device according to claim 1, The drug injection device is Receive user input data from the user terminal. The control unit, Based on the user input data, the drug injection conditions are calculated, and the control signal is output using the rate-based injection sequence corresponding to the drug injection conditions. The drug infusion device includes, as user input data, the user's blood glucose level, user activity information, or user's dietary information.

14. In the drug injection device according to claim 1, The drug injection device is The system receives the user's biometric measurement data from an external measuring device. The control unit, The system calculates the drug injection conditions based on the user's biometric data and outputs the control signal using the rate-based injection sequence corresponding to the drug injection conditions. The aforementioned user biometric data includes the user's blood glucose information or user activity information, and is a drug infusion device.

15. In a drug injection device according to any one of claims 12 to 14, A drug infusion device wherein the control unit sets the rate-based infusion sequence corresponding to the drug infusion condition by referring to a table in which a plurality of rate-based infusion sequences are stored for each drug infusion condition.

16. In the drug injection device according to claim 1, The drug injection device is The rate-based injection sequence set by the user terminal or user input / output interface module is received. The control unit, A drug infusion device that outputs the control signal using the aforementioned velocity-based infusion sequence.

17. In the drug injection device according to claim 1, The rate-based infusion sequence is calculated and received via an external computing device based on the user's past usage history of the drug infusion device, in a drug infusion device.

18. A method for operating a drug infusion device including a control unit and an electroosmotic pump, The control unit sets a rate-based infusion sequence for operating the drug infusion device in basal infusion mode. The control unit applies a control signal corresponding to the rate-based injection sequence to the electroosmotic pump, and The process includes a step in which, in response to the control signal, the electroosmotic pump alternately generates negative and positive pressure for each pulse block to inhale and discharge the drug, The velocity-based injection sequence is A plurality of pulse blocks of different types that define voltage pulses or current pulses applied to the electroosmotic pump and supply different amounts of drug, comprising a plurality of pulse blocks arranged to satisfy the drug infusion rate according to drug infusion conditions including drug infusion period and drug infusion rate, and a plurality of pause blocks that maintain a 0V voltage or 0A current for a predetermined time after the application of each pulse block, A method for operating a drug infusion device, wherein each pulse block defines a pair of pulse signals, including a forward pulse and a reverse pulse, which are applied to the electroosmotic pump and alternately generate negative and positive pressure.

19. In the method of operating the drug injection device according to claim 18, The step of the control unit setting the rate-based injection sequence is: A method for operating a drug infusion device, wherein the control unit sets the duration of the plurality of pulse blocks and the duration of the plurality of pause blocks arranged after the pulse blocks to correspond to the drug infusion period.

20. In the method of operating the drug injection device according to claim 18, The step of the control unit setting the rate-based injection sequence is: A method for operating a drug infusion device, wherein the control unit arranges the plurality of pulse blocks and pause blocks within a unit of time and sets the rate-based infusion sequence.

21. In the method of operating the drug injection device according to claim 19, The step of the control unit setting the rate-based injection sequence is: A method for operating a drug infusion device, wherein the control unit sets the duration of each pause block to be less than the recommended pause period.

22. In the method of operating the drug injection device according to claim 19, The step of the control unit setting the rate-based injection sequence is: A method for operating a drug infusion device, wherein the control unit arranges the pulse block that maximizes the amount of drug to be supplied among the plurality of pulse blocks so that it outputs first, and sets the rate-based infusion sequence.

23. In the method of operating the drug injection device according to claim 18, The step of the control unit setting the rate-based injection sequence is: A method for operating a drug infusion device, wherein the control unit sets the rate-based infusion sequence to include M types of pulse blocks (M being less than or equal to N, a natural number) selected from N types of pulse blocks (N being a natural number) that supply different amounts of drug, according to the drug infusion conditions, and the sum of the durations of the selected M types of pulse blocks and the durations of the plurality of pause blocks placed after each pulse block corresponds to the drug infusion period.

24. In the method of operating the drug injection device according to claim 23, When the control unit sets the rate-based injection sequence, A method for operating a drug infusion device, wherein the control unit sets the rate-based infusion sequence such that the M types of pulse blocks satisfy the drug infusion rate of the drug infusion conditions, the total number of uses for each selected pulse block is a preset number or the maximum number, and the duration of the pause block placed after each pulse block is less than the recommended pause period.

25. In the method of operating the drug injection device according to claim 19, The step of the control unit setting the rate-based injection sequence is: A method for operating a drug infusion device, wherein the control unit sets the arrangement of the pulse blocks and pause blocks assigned to each segment such that, according to segments obtained by dividing the drug infusion period into predetermined time units, the drug infusion rate is the same for some segments and different for other segments.

26. In the method of operating the drug injection device according to claim 18, The step of the control unit setting the rate-based injection sequence is: A method for operating a drug infusion device, wherein the control unit adjusts the magnitude and duration of a pair of voltage pulse signals or the magnitude and duration of a pair of current pulse signals to set the rate-based infusion sequence such that the amount of drug inhaled and the amount of drug discharged by the pair of voltage pulse signals or the pair of current pulse signals are equal.

27. In the method of operating the drug injection device according to claim 18, The pair of pulse signals are 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 or the reverse voltage pulse, A method for operating a drug infusion device, comprising a pair of current pulses including a forward current pulse and a reverse current pulse, and including a stabilization pulse that maintains a 0A current for a predetermined time after the application of the forward current pulse or the reverse current pulse.

28. In the method of operating the drug injection device according to claim 18, The step of the control unit setting the rate-based injection sequence is: A method for operating a drug infusion device, wherein the control unit sets the rate-based infusion sequence corresponding to the drug infusion conditions received by the drug infusion device from a user terminal or user input / output interface module.

29. In the method of operating the drug injection device according to claim 18, The step of the control unit setting the rate-based injection sequence is: The control unit calculates the drug injection conditions based on the user input data received by the drug injection device from the user terminal, and sets the rate-based injection sequence corresponding to the drug injection conditions. The aforementioned user input data includes the user's blood glucose level and user activity information, and the method of operating a drug infusion device.

30. In the method of operating the drug injection device according to claim 18, The step of the control unit setting the rate-based injection sequence is: The control unit calculates the drug injection conditions based on the user's biometric data received by the drug injection device from an external measuring device, and sets the rate-based injection sequence corresponding to the drug injection conditions. A method for operating a drug infusion device, wherein the user's biometric data includes the user's blood glucose information or the user's activity information.

31. In a method for operating a drug infusion device according to any one of claims 28 to 30, The step of the control unit setting the rate-based injection sequence is: A method for operating a drug infusion device, wherein the control unit refers to a table in which a plurality of rate-based infusion sequences are stored for each drug infusion condition, and sets the rate-based infusion sequence corresponding to the drug infusion condition.

32. In the method of operating the drug injection device according to claim 18, The step of the control unit setting the rate-based injection sequence is: A method for operating a drug infusion device, wherein the control unit receives the rate-based infusion sequence set by a user terminal or user input / output interface module and sets it as the rate-based infusion sequence.

33. In the method of operating the drug injection device according to claim 18, The step of the control unit setting the rate-based injection sequence is: A method for operating a drug infusion device, wherein the control unit receives the rate-based infusion sequence calculated based on the user's past usage history of the drug infusion device via an external computing device and sets it to the rate-based infusion sequence.

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