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 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.

Description

Technical Field

[0001] The present invention relates to a drug infusion 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 environment of a patient's daily life 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 it is a medical device that plays a role like the pancreas in accurately supplying insulin from the outside into the body 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 worn on the patient. Thus, since an insulin injector must inject a drug regularly for a long period for diabetic patients, active technological development for miniaturization and automation of the insulin injector has been carried out 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, and this is the main cause of the occlusion phenomenon. In particular, when the amount of the drug 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 a drug infusion device based on an electroosmotic pump for immediate infusion. 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 for solving the above-mentioned 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 a drug from a drug storage and discharges the drawn drug to an object to be injected, and a control unit that outputs a control signal to the drug injector corresponding to a volume-based injection sequence that drives the electroosmotic pump in immediate injection mode, wherein the volume-based injection sequence includes at least one pulse block that defines a voltage pulse or current pulse applied to the electroosmotic pump, each of which defines a pair of pulse signals applied to the electroosmotic pump, including a forward pulse and a reverse pulse that alternately generate negative pressure and positive pressure, and the electroosmotic pump 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 volume-based infusion sequence to operate a drug infusion device in 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, the electroosmotic pump alternately generates negative and positive pressure for each pulse block to inhale and discharge the drug, wherein the volume-based infusion sequence includes at least one pulse block that defines a voltage pulse or current pulse 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 applied to the electroosmotic pump and alternately generates negative and positive pressure. [Effects of the Invention]

[0011] According to the aforementioned solution to the problem of the present invention, a drug injector utilizing an electroosmotic pump can be controlled to inject a fixed amount of drug by setting a volume-based injection sequence according to the drug injection conditions. [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 volume-based injection sequence according to one embodiment of the present invention. [Figure 4] This table shows examples of multiple pulse blocks according to one embodiment of the present invention. [Figure 5] This is an illustrative diagram showing the signal structure for a quantity-based injection sequence according to one embodiment of the present invention. [Figure 6] This is an illustrative diagram showing the signal structure for a velocity-based injection sequence according to one embodiment of the present invention. [Figure 7] This table shows an example of a basal injection mode according to one embodiment of the present invention. [Figure 8] It is an exemplary diagram showing the signal structure for the base injection mode shown in FIG. 7. [Figure 9] It is an exemplary diagram showing the signal structure to which a quantity-based injection sequence is applied to the base injection mode shown in FIG. 8. [Figure 10] It is a block diagram schematically showing the configuration of the electroosmotic pump shown in FIG. 2. [Figure 11] It is a block diagram schematically showing the configuration of the drive unit shown in FIG. 10. [Figure 12] It is an exemplary diagram schematically showing the configuration of the drive unit shown in FIG. 6. [Figure 13] It is an exemplary diagram showing an application example of a drug injection device according to an embodiment of the present invention. [Figure 14] It is a block diagram schematically showing the configuration of the drug injection device shown in FIG. 13. [Figure 15] It is a block diagram schematically showing the configuration of the drug injection device shown in FIG. 13. [Figure 16] It is a flowchart for explaining a drug injection method according to an embodiment of the present invention. [Figure 17] It is a flowchart for explaining the process of applying the control signal shown in FIG. 16 to the electroosmotic pump.

Embodiments for Carrying Out the Invention

[0013] [[ID=3,6]] Hereinafter, the present invention will be described in detail with reference to the accompanying drawings. However, the present invention can be embodied in various different forms and is not limited to the embodiments described herein. Also, the attached drawings are only for facilitating the understanding of the embodiments disclosed in this specification and the technical idea disclosed in this specification is not limited by the attached drawings. In order to clearly explain the present invention in the drawings, parts not related to the explanation are omitted, and the sizes, forms, and shapes of each component shown in the drawings can be variously deformed. The same / similar parts throughout the specification are given the same / similar drawing reference numerals.

[0014] Suffixes such as "module" and "section" for components used in the following description are given or used interchangeably only for ease of preparing the specification, and do not have distinct meanings or roles by themselves. Also, when explaining the embodiments disclosed in this specification, if it is determined that a detailed 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 (comprised or had)" without excluding other components, unless otherwise stated.

[0016] Terms representing ordinal numbers such as first, second, etc. used in this specification are used only for the purpose of distinguishing one component from another, 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 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 immediate infusion mode to draw drug from the drug storage and dispense 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 volume-based injection sequence that drives the electroosmotic pump (110) in immediate infusion mode. Here, immediate infusion mode is a drug infusion mode in which a predetermined amount of drug is immediately injected into the user to lower the blood glucose level to a normal range when the user's blood glucose level rises rapidly or is expected to rise rapidly.

[0020] The control unit (200) may 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 injection 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 immediate injection mode of the drug injection device (10).

[0022] Figure 3 illustrates the concept of a volume-based injection sequence according to one embodiment of the present invention. The volume-based injection sequence will be explained in detail with reference to Figure 3.

[0023] A volume-based infusion sequence consists of multiple pulse blocks (20) arranged to meet the drug infusion volume, depending on the drug infusion conditions, including the drug infusion volume. In this case, an immediate infusion sequence is composed of multiple pulse blocks (20) that meet the drug infusion volume arranged continuously without intervals. Immediate infusion is sometimes defined as bolus infusion in a standard insulin infusion device.

[0024] Referring to Figure 3, the volume-based infusion sequence consists of multiple pulse blocks (20) arranged sequentially without any pauses between them. Each pulse block (20) defines a voltage or current pulse applied to the electroosmotic pump (110), and the duration of these pulses determines the amount of drug injected.

[0025] Figure 4 is a table showing examples of multiple pulse blocks according to one embodiment of the present invention, and Figure 5 is an illustrative diagram showing the signal structure for a quantity-based injection sequence according to one embodiment of the present invention.

[0026] Referring to Figures 4 and 5, the structure of a volume-based infusion sequence will be explained with an example. A volume-based infusion sequence is set up as follows to satisfy drug infusion conditions, including the amount of drug to be injected. A volume-based infusion sequence is a structure in which M pulse blocks (20) (M is less than or equal to N, a natural number) selected according to the amount of drug to be injected are arranged sequentially from N pulse blocks (20) (N is a natural number greater than or equal to 1) that supply different amounts of drug as shown in Figure 4. Here, the minimum number of pulse blocks (20) that can satisfy the amount of drug to be injected may be used, and among the pulse blocks (20) that can satisfy the amount of drug to be injected, the pulse block (20) that supplies the largest amount of drug is preferentially arranged.

[0027] For example, if the drug infusion volume is 5 μL, the volume-based infusion sequence consists of a fourth pulse block that delivers 3 μL and a third pulse block that delivers 2 μL, with the fourth pulse block being executed first, followed by the third pulse block. The fourth and third pulse blocks are executed without any gaps; once the fourth pulse block is completed, the third pulse block is executed immediately afterward.

[0028] Next, referring to Figures 4 and 5, the pulse blocks (20) are described as follows: Each pulse block (20) contains information for a pair of pulse signals, including a forward pulse and a reverse pulse, and includes information for 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, thereby alternately generating negative and positive pressure in each pulse block (20), causing the drug to be inhaled and discharged.

[0029] The pair of pulse signals (21,22) included in the pulse block (20) are either voltage pulse signals or current pulse signals. A pair of voltage pulse signals may consist of a forward voltage pulse and a reverse voltage pulse, and a pair of current pulse signals may consist of a forward current pulse and a reverse current pulse. Here, a pair of voltage pulse signals may include information on the magnitude and duration of each voltage pulse, and a pair of current pulse signals may include information on the magnitude and duration of each current pulse. For example, in the quantity-based injection sequence shown in Figure 5, the magnitude of the pulse signal may be 2V and the duration may be 10s.

[0030] Each pulse block (20) included in the quantity-based injection sequence may include voltage pulses having different voltages or current pulses having different currents. Alternatively, each pulse block (20) may include pulses having the same voltage or current pulses having the same current, but with different durations.

[0031] 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 maintained at the same level.

[0032] 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 5 is supplied with a constant voltage of 2V.

[0033] 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, so that the area of ​​the forward pulse and the area of ​​the reverse pulse are the same, and the amount of inhaled drug and the amount of drug dispensed are maintained to be equal.

[0034] 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 operation of the electroosmosis pump (110) can be stabilized through the stabilization pulse (23). Here, if the pulse block (20) of the volume-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.

[0035] The control unit (200) generates a control signal, such as a voltage pulse or current pulse, corresponding to the volume-based infusion sequence, based on the information of the pulse block (20) included in such a volume-based infusion sequence, and applies it to the drug injector (100). The drug injector (100), upon receiving the control signal, immediately performs the immediate infusion mode through the volume-based infusion sequence. However, if the drug injector (100) is operating in basal infusion mode by 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 and outputs the control signal corresponding to the volume-based infusion sequence to the drug injector (100).

[0036] Subsequently, once the drug injector (100) completes the immediate infusion mode, the control unit (200) again outputs a control signal to the drug injector (100) for the temporarily suspended rate-based infusion sequence. Here, the control unit (200) omits the operations set for the rate-based infusion sequence while the immediate infusion mode is being performed, and outputs a control signal for the rate-based infusion sequence that was set when the operations of the immediate infusion mode are completed.

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

[0038] The basal infusion mode consists of multiple rate-based infusion sequences arranged sequentially within a set drug infusion period. The basal infusion mode can be divided into multiple sequences by user settings. Each segment contains information regarding its duration and drug infusion rate during that duration, and each segment is constructed by repeatedly arranging a set rate-based infusion sequence per unit time to satisfy the drug infusion rate during its duration. The duration and drug infusion rate of each segment can be set by the user.

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

[0040] Referring to Figures 7 and 8, the basal infusion mode is explained with an example. In the basal infusion mode shown in Figure 7, 24 hours is divided into multiple segments, each with a set duration and drug infusion rate. The drug injector (100) performs the basal infusion mode by proceeding through each segment in the order shown in Figure 8. If the immediate infusion mode is executed at time t1 while the drug injector (100) is performing the second segment, a volume-based infusion sequence is placed in the middle of the second segment as shown in Figure 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) performs the basal infusion mode again. Here, the portion of the rate-based infusion sequence from time t1 to time t2 is omitted by the volume-based infusion sequence.

[0041] When a control signal corresponding to such a volume-based infusion sequence is applied to the electroosmotic pump (110), the electroosmotic pump (110) alternately generates negative and positive pressure in each pulse block, thereby 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).

[0042] Figure 10 is a block diagram schematically showing the configuration of the electroosmotic pump shown in Figure 2.

[0043] Referring to Figure 10, 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, which discharges the drug. The chamber (112) draws the drug from the drug storage unit (120) by the pressure of the drive unit (111) and then discharges the drug into the insertion unit (130). Here, the drug is a drug to be injected into a specific patient, and insulin injected into a diabetic patient can be given as an example.

[0044] Figure 11 is a schematic block diagram showing the configuration of the drive unit shown in Figure 10, and Figure 12 is an illustrative diagram showing the configuration of the drive unit shown in Figure 11.

[0045] Referring specifically to Figures 11 and 12, 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.

[0046] 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 are advanced (moving in the direction of circled number 2), and the fluid to be transferred is discharged from the chamber (112).

[0047] 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).

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

[0049] 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.

[0050] 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.

[0051] 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. The repeated occurrence of forward and reverse electrochemical reactions causes the fluid inside the electroosmotic pump to perform repeated reciprocating motion. Furthermore, the repeated reversible forward and reverse electrochemical reactions cause repeated consumption and regeneration of the fluid at the first electrode (111b) and the second electrode (111c). When an inhalation valve (140) and a discharge valve (150) are connected to the chamber (112) of such an electroosmotic pump (110), during inhalation, the drug in the drug storage unit (120) is drawn in through the inhalation passage (141) 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).

[0052] 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.

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

[0054] The drug infusion device (10) receives predetermined information from the user and sets a volume-based infusion sequence based on this information. The process of setting a volume-based infusion sequence can be divided into different parts depending on the data used to set the volume-based infusion sequence. The process of setting a volume-based infusion sequence will be described below.

[0055] Referring to Figure 14, the process by which a drug infusion device (10) according to one embodiment of the present invention sets a volume-based infusion sequence is described.

[0056] The drug infusion device (10) can set a volume-based infusion sequence using drug infusion conditions, where the drug infusion conditions include the drug infusion volume. 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 volume-based infusion sequence corresponding to the drug infusion conditions and transmits a corresponding control signal to the drug injector (100).

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

[0058] 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).

[0059] Furthermore, the drug infusion device (10) can set a volume-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 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. The control unit (200) then sets a volume-based infusion sequence corresponding to the drug infusion conditions and transmits a control signal corresponding to the volume-based infusion sequence to the drug injector (100).

[0060] Furthermore, the drug infusion device (10) can set a volume-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 volume-based infusion sequence corresponding to the drug infusion conditions and transmits a control signal corresponding to the volume-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.

[0061] Next, referring to Figure 15, we will explain the process by which the drug infusion device sets up a volume-based infusion sequence.

[0062] The drug infusion device (10) can set a volume-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.

[0063] The control unit (200) sets a volume-based 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 volume-based infusion sequence is not set using the drug infusion conditions, but can also be selected directly by the user through the user interface module (400).

[0064] 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).

[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 a volume-based infusion sequence via a touchscreen display.

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

[0067] Figure 16 is a flowchart 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. The drug infusion method (S100) sets a volume-based infusion sequence to operate the drug infusion device (10) in immediate infusion mode (step S110), and applies a control signal corresponding to the volume-based infusion sequence to the electroosmotic pump (110) (step S120). Subsequently, in response to the control signal, the electroosmotic pump (110) alternately generates negative and positive pressure in each pulse, inhales and discharges the drug, and injects the drug into the user (step S130). Here, the volume-based infusion sequence includes at least one pulse block that defines a voltage pulse or current pulse 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] The following sections will explain each stage in detail.

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

[0071] 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 volume-based infusion sequence corresponding to the drug infusion conditions and transmits a corresponding control signal to the drug injector (100). However, the volume-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).

[0072] 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 volume-based infusion sequence corresponding to the drug infusion conditions and transmits a control signal to the drug injector (100). Here, the volume-based infusion sequence is not set using the drug infusion conditions, but can also be selected directly by the user through the user interface module (400).

[0073] Furthermore, the drug infusion device (10) can set a volume-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. 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 volume-based infusion sequence corresponding to the drug infusion conditions and transmits a control signal corresponding to the volume-based infusion sequence to the drug injector (100).

[0074] Furthermore, the drug infusion device (10) can set a volume-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 volume-based infusion sequence corresponding to the drug infusion conditions and transmits a control signal corresponding to the volume-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.

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

[0076] Figure 17 is a flowchart illustrating the process of applying the control signal shown in Figure 16 to the electroosmotic pump.

[0077] Referring to Figure 17, in the process of applying a control signal to the electroosmotic pump (step S120), if the drug injector (100) is operating in 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 infusion sequence may include a voltage pulse pair containing a forward voltage pulse and a reverse voltage pulse, or a current pulse pair containing a forward current pulse and a reverse current pulse, through which the electroosmotic pump alternately generates negative and positive pressure for each pulse block, performing the operation of inhaling and discharging the drug, and infusing the drug to the user in immediate infusion mode (step S130).

[0079] Subsequently, once the immediate infusion mode is complete, the control unit (200) again outputs a control signal to the drug injector (100) for the temporarily interrupted rate-based infusion sequence. Here, the control unit (200) omits the operations set for the rate-based infusion sequence while the immediate infusion mode is being performed, and outputs a control signal for the rate-based infusion sequence that was set at the time the immediate infusion mode operation was completed.

[0080] A method according to one embodiment of the present invention may also be embodied in the form of a recording medium containing commands 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.

[0081] 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.

[0082] A person with ordinary skill in the art to which this invention belongs will understand that, based on the above description, the invention can be easily modified into other specific forms without altering the technical idea or essential features. Therefore, the embodiments described above should be understood to be illustrative and not limiting in all respects. The scope of this invention is indicated 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 this invention.

[0083] The scope of this application is indicated 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 drugs from a drug storage chamber and discharges the drawn drugs 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 volume-based infusion sequence that drives the electroosmotic pump in immediate infusion mode. The aforementioned volume-based injection sequence is Multiple pulse blocks, which define voltage pulses or current pulses applied to the electroosmotic pump and supply different amounts of drug, are arranged to satisfy the drug injection amount according to drug injection conditions, including the drug injection amount. 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 to inhale and discharge the drug.

2. In the drug injection device according to claim 1, The aforementioned volume-based injection sequence is A drug infusion device comprising M pulse blocks (where M is less than or equal to N) selected from N pulse blocks (where N is a natural number) that supply different amounts of drug, wherein the pulse block that best satisfies the target drug infusion amount is preferentially arranged.

3. In the drug injection device according to claim 1, The aforementioned volume-based injection sequence is a drug infusion device in which multiple types of pulse blocks are arranged in sequence.

4. In the drug injection device according to claim 1, A drug infusion 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 the amount of drug discharged by the electroosmotic pump are the same.

5. 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.

6. In the drug injection device according to claim 1, The control unit, When the drug injector is operating in basal infusion mode according to a preset rate-based infusion sequence, the output of the control signal corresponding to the rate-based infusion sequence is temporarily suspended, and the output of the control signal corresponding to the volume-based infusion sequence is then released. The velocity-based injection sequence is A drug infusion device comprising at least one pulse block defining 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.

7. In the drug infusion device according to claim 6, The control unit, A drug infusion device that, once the operation of the immediate infusion mode in accordance with the volume-based infusion sequence is completed, continues to output the control signal for the interrupted rate-based infusion sequence.

8. In the drug infusion device according to claim 6, The control unit, Once the operation of the immediate injection mode according to the volume-based injection sequence is completed, the control signal for the temporarily suspended rate-based injection sequence is output again. A drug infusion device that omits the operation according to the rate-based infusion sequence that was scheduled during the interrupted period, and performs the operation according to the rate-based infusion sequence that was scheduled when the operation of the immediate infusion mode is completed.

9. 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, after drawing a drug from the drug storage chamber according to the pressure of the drive unit, discharges the drug into the insertion unit.

10. In the drug injection device according to claim 1, The drug injection device is A drug infusion device that receives the drug infusion conditions from a user terminal or user input / output interface module.

11. In the drug injection device according to claim 8, 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 volume-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.

12. 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 volume-based injection sequence corresponding to the drug injection conditions. A drug infusion device in which the user's biometric data includes the user's blood glucose information or the user's activity information.

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

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

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

16. A method for operating a drug infusion device including a control unit and an electroosmotic pump, The control unit sets a volume-based infusion sequence to operate the drug infusion device in immediate infusion mode. The control unit applies a control signal to the electroosmotic pump corresponding to the volume-based injection sequence, and The step 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 aforementioned volume-based injection sequence is Multiple pulse blocks, which define voltage pulses or current pulses applied to the electroosmotic pump and supply different amounts of drug, are arranged to satisfy the drug injection amount according to drug injection conditions, including the drug injection amount. 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.

17. In the method of operating the drug injection device according to claim 16, The step in which the control unit sets the volume-based injection sequence is: A method for operating a drug injection device, wherein the control unit arranges M types of pulse blocks (M being less than or equal to N) selected from N types of pulse blocks (N being a natural number) that supply different amounts of drug, and preferentially arranges the largest pulse block that satisfies the target drug injection amount.

18. In the method of operating the drug injection device according to claim 16, The step in which the control unit sets the volume-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 signals to set the volume-based infusion sequence so 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 the same.

19. In the method of operating the drug injection device according to claim 16, 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.

20. In the method of operating the drug injection device according to claim 16, The step in which the control unit sets the volume-based injection sequence is: A method for operating a drug infusion device, wherein the control unit sets the volume-based infusion sequence corresponding to the drug infusion conditions received from a user terminal or user input / output interface module.

21. In the method of operating the drug injection device according to claim 16, The step in which the control unit sets the volume-based injection sequence is: The control unit calculates the drug injection conditions based on user input data received from the user terminal, and sets a quantity-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.

22. In the method of operating the drug injection device according to claim 16, The step in which the control unit sets the volume-based injection sequence is: The control unit calculates the drug injection conditions based on the user's biometric measurement data received from an external measuring device, and sets a volume-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.

23. In the method of operating a drug infusion device according to any one of claims 20 to 22, The step in which the control unit sets the volume-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 volume-based infusion sequences are stored for each drug infusion condition and sets the volume-based infusion sequence corresponding to the drug infusion condition.

24. In the method of operating the drug injection device according to claim 16, The step in which the control unit sets the volume-based injection sequence is: A method for operating a drug infusion device, wherein the control unit receives the volume-based infusion sequence set by a user terminal or user input / output interface module and sets it as the volume-based infusion sequence.

25. In the method of operating the drug injection device according to claim 16, The step in which the control unit sets the volume-based injection sequence is: A method for operating a drug infusion device, wherein the control unit receives the volume-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 volume-based infusion sequence.

26. In the method of operating the drug injection device according to claim 16, The step of the control unit applying the control signal to the electroosmotic pump is: When the drug infusion device is operating in basal infusion mode with a pre-set rate-based infusion sequence, The control unit temporarily suspends the output of the control signal corresponding to the rate-based injection sequence, and The control unit includes the step of outputting the control signal corresponding to the quantity-based injection sequence, The velocity-based injection sequence is A method for operating a drug infusion device, comprising at least one pulse block defining 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.

27. In the method of operating the drug injection device according to claim 26, A method for operating a drug infusion device, further comprising the step of the control unit continuing to output the control signal for the temporarily interrupted rate-based infusion sequence once the immediate infusion mode according to the volume-based infusion sequence is completed.

Images