Drug injection device and method
The electroosmotic pump-based drug infusion device addresses clogging issues in insulin injectors by using a rate-based infusion sequence with alternating pressures, ensuring stable and precise drug delivery.
Patent Information
- Application Number
- JP2025512002
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-06-07
- Filing Date
- 2023-06-26
- Publication Date
- 2025-08-15
- Estimated Expiration
- 2043-06-26
AI Technical Summary
Insulin injectors face challenges in maintaining stable operation due to back pressure at the cannula tip caused by drug-biological fluid reactions, particularly when injecting small amounts or at slow rates, leading to clogging issues.
A drug infusion device using an electroosmotic pump driven by electrochemical means, with a controller implementing a rate-based infusion sequence that includes pulse blocks for alternating negative and positive pressures to aspirate and expel drugs, and pause blocks to maintain zero voltage or current, preventing clogging.
The device ensures precise and continuous drug delivery while minimizing clogging by alternately generating negative and positive pressures, allowing for stable operation and accurate dosing.
Smart Images

Figure 2025527027000001_ABST
Abstract
Description
[Technical Field]
[0001] The present invention relates to a drug infusion device and method. [Background technology]
[0002] Drugs can be injected into the body in various ways, such as orally, subcutaneously, or intravenously, depending on the type, purpose, and method of treatment. Drug injectors using drug pumps can automatically inject drugs into the body at a desired rate and volume at a required time. Therefore, drug injectors using drug pumps can be used in a variety of ways, not only in hospitals and in patients' daily lives.
[0003] Insulin pumps, commonly known as insulin syringes, are medical devices for diabetics who do not secrete insulin or who secrete only small amounts of it. They act like the pancreas, supplying insulin to the body from the outside at precise times to regulate blood sugar levels.
[0004] Such insulin pumps are used by insulin-dependent diabetics and can inject medicine continuously 24 hours a day while attached to the patient. Because insulin injectors must inject medicine into diabetics regularly over a long period of time, active development is underway to miniaturize and automate insulin injectors for user convenience.
[0005] However, as insulin injectors become smaller and more automated, it is becoming increasingly difficult to ensure stable operation of the insulin injector. This is mainly due to back pressure at the tip of the cannula or needle caused by various reactions between the drug and biological fluids. This clogging problem becomes more serious when the amount of drug being injected is small or is injected slowly.
[0006] Therefore, there is a need for a method for continuously injecting a drug into a patient, while at the same time stably injecting a precise amount of drug and controlling the drug injection so that the drug injection channel does not become clogged during drug injection. Summary of the Invention [Problem to be solved by the invention]
[0007] SUMMARY OF THE INVENTION In order to solve the above-mentioned problems, the technical object of the present invention is to provide a drug infusion method for basal infusion in an electroosmotic pump-based drug infusion device.
[0008] However, the technical problem that this embodiment aims to achieve is not limited to the above-mentioned technical problem, and other technical problems may exist. [Means for solving the problem]
[0009] As a technical solution to the above-mentioned technical problems, one embodiment of the present invention provides a drug infusion device that includes a drug injector that electrochemically drives an electroosmotic pump to inhale a drug from a drug reservoir and expel the inhaled drug to an infusion target, and a controller that outputs a control signal to the drug injector corresponding to a rate-based infusion sequence that operates the electroosmotic pump in a basal infusion mode. The rate-based infusion sequence includes at least one pulse block that applies a voltage pulse or a current pulse to the electroosmotic pump, and at least one pause block that maintains a 0 V voltage or 0 A current for a predetermined period of time after the application of the pulse block. 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 and positive pressures. The electroosmosis inhales and expels the drug by alternately generating negative and positive pressures for each pulse block.
[0010] Furthermore, a drug infusion method according to one embodiment of the present invention includes the steps of setting a rate-based infusion sequence for operating a drug infusion device in a basal infusion mode, applying a control signal corresponding to the rate-based infusion sequence to the electroosmotic pump, and, in response to the control signal, causing the electroosmotic pump to alternately generate negative and positive pressure for each pulse block to inhale and expel drug. 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 period of 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 pressure. [Effects of the Invention]
[0011] According to the above-described means for solving the problems of the present invention, a rate-based injection sequence according to drug injection conditions can be set for a drug injector that uses an electroosmotic pump, and the drug injector can be controlled to inject a fixed amount of drug. [Brief explanation of the drawings]
[0012] [Figure 1] 1 is a block diagram that illustrates a schematic diagram of a drug injection device according to an embodiment of the present invention; [Figure 2] FIG. 2 is a block diagram showing a schematic configuration of the drug injector shown in FIG. 1. [Figure 3] FIG. 1 is a conceptual diagram that outlines a rate-based injection sequence in accordance with an embodiment of the present invention. [Figure 4] 1 is a table illustrating several exemplary rate-based injection sequences according to one embodiment of the present invention. [Figure 5] 10 is a table illustrating an example of multiple pulse blocks according to one embodiment of the present invention. [Figure 6] 1 is a table showing an example of a drug infusion period according to one embodiment of the present invention. [Figure 7]FIG. 10 is an exemplary diagram illustrating a signal structure for a rate-based injection sequence according to one embodiment of the present invention. [Figure 8] FIG. 3 is a block diagram showing a schematic configuration of the electroosmotic pump shown in FIG. 2. [Figure 9] FIG. 9 is a block diagram schematically showing the configuration of a drive unit shown in FIG. 8. [Figure 10] 10 is an exemplary diagram illustrating a schematic configuration of a driving unit illustrated in FIG. 9. FIG. [Figure 11] 1 is an exemplary application diagram of a drug injection device according to an embodiment of the present invention; [Figure 12] FIG. 12 is a block diagram showing the general configuration of the drug injection device shown in FIG. [Figure 13] FIG. 12 is a block diagram showing the general configuration of the drug injection device shown in FIG. [Figure 14] 1 is a flow chart illustrating a drug injection method according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION
[0013] The present invention will be described in detail below with reference to the accompanying drawings. However, the present invention may be embodied in various different forms and is not limited to the embodiments described herein. Furthermore, the accompanying drawings are merely provided to facilitate understanding of the embodiments disclosed herein, and the technical ideas disclosed herein are not limited by the accompanying drawings. To clearly illustrate the present invention in the drawings, parts that are not relevant to the description are omitted, and the size, shape, and form of each component shown in the drawings may be modified in various ways. The same or similar reference numerals are used throughout the specification to refer to the same or similar parts.
[0014] The suffixes "module" and "section" for components used in the following description are given or mixed for the sole purpose of facilitating the preparation of the specification, and do not have any distinct meanings or roles. In addition, in describing the embodiments disclosed herein, if it is determined that a detailed description of related publicly known technology may obscure the gist of the embodiments disclosed herein, such a detailed description has been omitted.
[0015] Throughout this specification, a part being "coupled (connected, in contact, or coupled)" to another part includes not only a "directly coupled (connected, in contact, or coupled)" part, but also an "indirectly coupled (connected, in contact, or coupled)" part with another member interposed therebetween. Furthermore, when a part "includes (comprises or comprises)" a certain component, it does not exclude other components, but means that it may further "include (comprises or comprises)" the other components, unless otherwise specified.
[0016] As used herein, ordinal terms such as "first," "second," etc. are used only to distinguish one component from another, and do not limit the order or relationship of the components. For example, a first component of the present invention may be designated as a second component, and similarly, the second component may be designated as a first component.
[0017] FIG. 1 is a block diagram showing the configuration of a drug injection device according to one embodiment of the present invention, and FIG. 2 is a block diagram showing the configuration of the drug injector shown in FIG.
[0018] Referring to FIGS. 1 and 2, a drug injection device (10) according to one embodiment of the present invention will be described. The drug injection device (10) includes a drug injector (100) and a control unit (200).
[0019] The drug injector 100 electrochemically operates the electroosmotic pump 110 in a basal infusion mode to inhale a drug from a drug reservoir and discharge the inhaled drug into an infusion target. The control unit 200 outputs a control signal corresponding to a rate-based infusion sequence to the drug injector 100, which drives the electroosmotic pump 110 in the basal infusion mode. The basal infusion mode is a drug infusion mode in which a drug is infused into a user for a certain period of time to maintain a constant blood glucose level of the user.
[0020] The control unit (200) may refer to a data processing device built into hardware having a circuit physically structured to perform a function expressed by a code or command contained in a program. Examples of such a data processing device built into hardware include a microprocessor, a central processing unit (CPU), a processor core, a multiprocessor, an application-specific integrated circuit (ASIC), a field programmable gate array (FPGA), a microcontroller unit (MCU), an embedded processor, etc., but the scope of the present invention is not limited thereto.
[0021] Meanwhile, the control unit (200) may be implemented not only in a form independently built into the drug injection device (10), but also in a form connected to the user terminal (40) described later via a communication module, with the user terminal (40) and the control unit (200) integrated to control the basal infusion mode of the drug injection device (10).
[0022] Figure 3 is a diagram illustrating the concept of a rate-based injection sequence according to an embodiment of the present invention, and Figures 4 to 7 are exemplary diagrams illustrating a rate-based injection sequence according to an embodiment of the present invention. Hereinafter, the rate-based injection sequence will be described in detail with reference to Figures 3 to 7.
[0023] The rate-based infusion sequence is configured by arranging multiple pulse blocks (20) to satisfy a drug infusion rate according to drug conditions including the drug infusion period and the drug infusion rate. In this case, the rate-based infusion sequence is configured by arranging multiple pulse blocks to satisfy a drug infusion rate during a unit time (e.g., 1 hour or 30 minutes), and repeating this during the drug infusion period.
[0024] Referring to Figure 3(a), a rate-based infusion sequence consists of multiple pulse blocks (20) and multiple pause blocks (30), beginning with a pulse block (20) and followed by a pause block (30). The pulse block (20) defines a voltage or current pulse applied to the electroosmotic pump (110), and the amount of drug infused varies depending on its duration. The pause block (30) maintains a 0 V voltage or 0 A current for a predetermined period of time after the application of the pulse block (20).
[0025] To satisfy the drug infusion conditions, including the drug infusion period and the drug infusion rate, a rate-based infusion sequence is set as follows. First, to satisfy the drug infusion rate, pulse blocks must be placed to satisfy the drug infusion amount per unit time. In the present invention, various pulse blocks can be set through the electroosmotic pump (110). However, during the drug infusion period, multiple or a predetermined number of pulse blocks are placed, if possible, so that the pause periods of the pause blocks placed after each pulse block are as short as possible to prevent the drug from drying out or the occurrence of a blockage phenomenon. To satisfy these conditions, a rate-based infusion sequence can be set as follows.
[0026] A rate-based infusion sequence includes M pulse blocks (20) (M is a natural number equal to or smaller than N) selected from N pulse blocks (20) (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) that make up the rate-based infusion sequence are configured in a combination in which 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) that make up the rate-based infusion sequence is a preset number according to the unit time or the maximum number that can indicate the drug infusion rate.
[0027] The total duration of the multiple pulse blocks (20) included in the rate-based infusion sequence and the multiple pause blocks (30) placed after the pulse blocks (20) is set to correspond to a unit time, and the pulse blocks (20) are placed so that the pulse block (20) that supplies the largest amount of drug among the pulse blocks (20) is output first, but the placement of subsequent pulse blocks (20) may be changed by selection.
[0028] The M pulse blocks (20) that make up the rate-based infusion sequence may also be set so 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, so that 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 showing several exemplary rate-based infusion sequences, and Figure 5 is a table showing an exemplary set of N pulse blocks 30 for infusing different amounts of drug. Rate-based infusion sequences will now be described by way of example with reference 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 is composed of a combination of M pulse blocks (20) from the N pulse blocks (20) shown in Figure 5 that deliver different amounts of drug, 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 delivers the largest amount of drug is output first among the pulse blocks (20) that make up the rate-based infusion sequence.
[0031] Here, the rate-based infusion sequence is configured so that 12 pulse blocks (20) can be placed. When all 12 pulse blocks (20) are placed, the sequence is configured to combine pulse blocks (20) to satisfy the drug infusion rate. For example, a rate-based infusion sequence with a drug infusion rate of 0.7 U / hr is configured with two pulse blocks (20) that deliver 0.5 μL and 1 μL, with the 1 μL pulse block (20) placed first. The total number of times each of the 0.5 μL and 1 μL pulse blocks (20) is used is a preset number of 12. Here, in Figure 4, the drug infusion volume of the rate-based infusion sequence is expressed in U units, and in Figure 5, the drug infusion volume of the pulse block (20) is expressed in μ units. 1 U is the same as 10 μL. Therefore, 0.35 U is the same as 3.5 μL.
[0032] Although not shown in the table, a pause block 30 is always placed after a pulse block 20, and the duration of the pause block 30 is set to less than the recommended duration to prevent blockage. 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 explain the process of setting the duration of a pause block 30, for example, in Figure 4, each rate-based injection sequence has a structure in which 12 pulse blocks 20 are arranged, so 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 arranged after a pulse block 20 that injects 0.5 μL is 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, so the duration of the pause block 30 is set to 294.6 seconds, which is 300 seconds minus 5.4 seconds.
[0034] Furthermore, a rate-based infusion sequence may encounter situations where there are no pulse blocks (20) that meet the preset number. This can occur if the number of pulse blocks is less than or exceeds the preset number. For example, in FIG. 4, a rate-based infusion sequence with a drug infusion rate of 0.35 U / hr to 0.55 U / hr is configured with fewer than 12 pulse blocks (20). In such cases, the maximum number of pulse blocks (20) that can be placed to meet the drug infusion rate is determined. For a rate-based infusion sequence with a rate of 3.45 U / hr, the number of pulse blocks (20) is 13, exceeding 12. In such cases, the structure of the rate-based infusion sequence is reconfigured to one where 13 pulse blocks (20) are placed per hour, and pulse blocks (20) and pause blocks (20) can be placed.
[0035] Although FIG. 4 shows an example of a rate-based injection sequence structure in which the unit time is set to one hour, this is not limiting, and the number and structure of pulse blocks (20) constituting the rate-based injection sequence may vary depending on the set unit time.
[0036] Such rate-based infusion sequences are continuously arranged during a drug infusion period. Specifically, the drug infusion period can be divided into at least one or more segments, each of which includes information about a duration and a drug infusion rate during the 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 the duration. Here, the duration and drug infusion rate of each segment can be set by the user.
[0037] An example of a drug infusion period configured with rate-based infusion sequences will be described with reference to FIG. 6. FIG. 6 shows a state in which the drug infusion period is set to 24 hours and the 24 hours are divided into a plurality of segments each having a predetermined time slot. Regarding the structure of the first segment, the first segment is a period in which a drug is infused at a rate of 0.7 U / hour for 2 hours, and two rate-based infusion sequences having a drug infusion rate of 0.7 U / hour as shown in FIG. 4 are arranged consecutively. Here, each segment is set in one-hour increments, but this is not limiting and the segments may be divided by a predetermined unit of time.
[0038] 3(b) and 7, the pulse block 20 will be described. Each pulse block 30 includes information about a pair of pulse signals including a forward pulse and a reverse pulse, and information about the amplitude and duration of each pulse. The pair of pulse signals including a forward pulse and a reverse pulse are applied to the electroosmotic pump 110 to generate alternating negative and positive pressures, thereby generating alternating negative and positive pressures for each pulse block 20, thereby inhaling and exhaling the drug.
[0039] The pair of pulse signals (21, 22) included in the pulse block (30) may be voltage pulse signals or current pulse signals. The pair of voltage pulse signals may be composed of a forward voltage pulse and a reverse voltage pulse, and the pair of current pulse signals may be composed of a forward current pulse and a reverse current pulse. Here, the pair of voltage pulse signals may include information 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 rate-based injection sequence shown in FIG. 7, the magnitude of the pulse signals may be 2 V and the hold time may be 10 s.
[0040] Each pulse block 20 included in a rate-based injection sequence can include voltage pulses having different voltage magnitudes or current pulses having different current magnitudes, or each pulse block 20 can include pulses having the same voltage magnitude or current magnitude but with different durations.
[0041] The forward pulse (21) and the reverse pulse (22) included in the pulse block (20) are set to have the same magnitude and duration, so that the amount of drug inhaled and expelled by the electroosmotic pump (110) can be kept the same.
[0042] Furthermore, the pair of pulse signals (21, 22) included in the pulse block (20) can be provided by a constant voltage or a constant current, and the amount of drug inhaled and exhaled by each pulse block can be adjusted by adjusting the duration of the pulse signal provided by the constant voltage or constant current. For example, the pulse block (20) in Figure 7 is provided by a constant voltage of 2 V.
[0043] Furthermore, the pair of pulse signals (21, 22) can be adjusted in both magnitude and duration so that the amounts of inhaled and exhaled drug are equal. For example, the forward voltage pulse can be set to a magnitude of 2 V and a duration of 10 s, and the subsequent reverse voltage pulse can be set to a magnitude of 1 V and a duration of 20 s, with the areas of the forward pulse and the reverse pulse set to the same, so that the amounts of inhaled and exhaled drug are kept equal.
[0044] Each pulse block (20) may further include a stabilization pulse (23), which maintains a 0 V voltage for a predetermined time after the application of the forward voltage pulse (21) and the reverse voltage pulse (22). The stabilization pulse (23) may stabilize the operation of the electroosmotic pump (110). Here, if the pulse block (20) of the rate-based injection sequence is composed of a pair of current pulses, the pulse block (20) may further include a stabilization pulse (23) which maintains a 0 A current for a predetermined time after the application of the forward current pulse and the reverse current pulse.
[0045] Next, the pause block (30) is placed after the pulse block (20) is applied and is a signal in which 0V voltage or 0A current is maintained for a predetermined period of time. The drug infusion device (10) of the present invention injects a drug into the user for a predetermined drug infusion amount over a predetermined period of time. Therefore, the pause block (30) included in the rate-based infusion sequence can control the time during which the target drug infusion amount is injected, and by minimizing the time during which no drug is injected, it is possible to prevent the flow path of the drug injector (100) from becoming clogged during periods during which no drug is injected.
[0046] The control unit (200) generates a control signal consisting of a voltage pulse or a current pulse corresponding to the rate-based injection sequence based on the information of the pulse block (20) included in the rate-based injection sequence and applies it to the drug injector (100).
[0047] When a control signal corresponding to such a rate-based injection sequence is applied to the electroosmotic pump 110, the electroosmotic pump 110 alternately generates negative and positive pressure for each pulse block, thereby drawing in and expelling the drug. Here, the control signal may be a signal consisting of a voltage pulse pair including a forward voltage pulse and a reverse voltage pulse or a current pulse pair including a forward current pulse and a reverse current pulse for each pulse block 20.
[0048] FIG. 8 is a block diagram showing a schematic configuration of the electroosmotic pump shown in FIG.
[0049] 8, the electroosmotic pump 110 includes a driving unit 111 and a chamber 112. The driving unit 111 is electrochemically driven by a control signal to generate positive and negative pressures and discharge a drug in response to the positive and negative pressures, while the chamber 112 draws in a drug from a drug reservoir 120 in response to the pressure of the driving unit 111 and then discharges the drug into the insertion unit 130. The drug is a drug that must be injected into a specific patient, such as insulin injected into a diabetic patient.
[0050] FIG. 9 is a block diagram schematically illustrating the configuration of the driving unit shown in FIG. 8, and FIG. 10 is an exemplary diagram schematically illustrating the configuration of the driving unit shown in FIG.
[0051] 9 and 10, the driving unit (111) is a pump that utilizes the electroosmotic phenomenon that occurs when a voltage or current is applied to both ends of a porous membrane (membrane 111a) using electrodes to move a fluid. The driving unit (111) includes a power source (111d) that applies a voltage or current to the membrane (111a) and first and second electrodes (111b and 111c) disposed on both sides of the membrane (111a), and a flow path for moving the fluid.
[0052] The actuator 111 may include a first diaphragm 111e disposed adjacent to the first electrode 111b and a second diaphragm 111f disposed adjacent to the second electrode 111c. Each diaphragm 111e, 111f is provided on one side and the other side of the membrane 111a, and changes shape as the pumping solution moves due to the alternating generation of positive and negative pressures. For example, the first diaphragm 111e and the second diaphragm 111f transmit the negative and positive pressures generated by the actuation of the membrane 111a to the fluid to be pumped. More specifically, when negative pressure is generated, at least a portion of the first diaphragm (111e) and the second diaphragm (111f) retreats (when moving in the direction of the circled number 1), and the fluid to be transferred is sucked into the chamber (112); conversely, when positive pressure is generated, at least a portion of the first diaphragm (111e) and the second diaphragm (111f) advances (when moving in the direction of the circled number 2), and the fluid to be transferred is discharged from the chamber (112).
[0053] The porous membrane (111a) is typically made of silica or glass, which becomes negatively charged when immersed in an aqueous solution. The porous membrane (111a) has numerous fluid-passing channels. A close-up of one of these channels reveals that the negatively charged fluid surface can be balanced by mobile positively charged cations. Applying a positive voltage to the first electrode (111b) and a negative voltage to the second electrode (111c) generates negative pressure, which moves the fluid inside the actuator (111) in the direction indicated by the circled number 1. The drug is then inhaled through the inhalation channel (141) and flows into the chamber (112) via the inhalation valve (140). The discharge valve (150) is closed, preventing negative pressure from being transmitted to the discharge channel (151). Conversely, when a negative voltage is applied to the first electrode (111b) and a positive voltage is applied to the second electrode (111c), a reversible electrochemical reaction generates a positive pressure in the opposite direction. This positive pressure causes the fluid inside the actuator (111) to move in the direction of the circled number 2. At this time, the drug stored in the chamber (112) flows into the subject through the discharge valve (150) and the discharge passage (151). At this time, the intake valve (140) is closed, preventing positive pressure from being transmitted to the intake passage (141).
[0054] This phenomenon is called electroosmosis, and the pump that utilizes this principle is the electroosmotic pump (110).
[0055] The electrodes used in the driving unit (111) may be provided in the form of porous electrodes such as platinum mesh, porous carbon paper or fiber, or various electrode materials coated on a porous structure to facilitate fluid movement.
[0056] In addition, the electrodes used in the actuator 111 may be applied to a non-transparent substrate and may be coated with various immobilizable materials by drop coating, spin coating, etc. In this case, the non-transparent substrate may be a plate-shaped substrate including at least one of a conductive material, a semiconductor material, and a non-conductive material, and the electrode material coated thereon may be a metal, a metal oxide, a conducting polymer, a metal hexacyanoferrate, a carbon nanostructure, or a composite thereof.
[0057] The driving unit (111) alternately supplies voltage or current polarity to the first electrode (111b) and the second electrode (111c), respectively, causing reversible forward and reverse electrochemical reactions. The repeated forward and reverse electrochemical reactions cause the fluid inside the electroosmotic pump to repeatedly reciprocate. The repeated reversible forward and reverse electrochemical reactions also cause the fluid to be repeatedly consumed and regenerated at the first electrode (111b) and the second electrode (111c). When the suction valve (140) and the discharge valve (150) are respectively connected to the chamber (112) of the electroosmotic pump (110), the drug in the drug reservoir (120) is drawn in through the suction passage (141) during the suction operation, passes through the suction valve (140), and is stored in the chamber (112). During the discharging operation, the medicine stored in the chamber (112) is discharged through the discharge valve (150) and the discharge passage (151) into the insertion part (130).
[0058] Therefore, by controlling the magnitude and duration of the voltage or current applied to the first and second electrodes (111b, 111c), the pressure generated by the electroosmotic pump (110) and the volume of drug ejected can be controlled.
[0059] Figure 11 is an example of an application of a drug injection device according to one embodiment of the present invention, Figure 12 is a block diagram showing the configuration of the drug injection device shown in Figure 11, and Figure 13 is a block diagram showing the configuration of the drug injection device shown in Figure 11. The operation of drug injection device 10 will be described in detail with reference to Figures 11 to 13.
[0060] The drug injection device 10 receives predetermined information from the user and sets a rate-based infusion sequence based on the information. The process of setting a rate-based infusion sequence can be categorized according to the data used to set the rate-based infusion sequence. The process of setting a 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 up 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, which include a drug infusion period and a drug infusion rate. A 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. The drug infusion device 10 then sets a rate-based infusion sequence based on the conditions set for each segment.
[0063] The drug injection device 10 may further include a communication module 300 for receiving drug injection conditions from a user terminal 40. The drug injection conditions are input by a user via the user terminal 40, which is communicatively connected to the drug injection device 10 via the communication module 300. The control unit 200 then sets a rate-based injection sequence corresponding to the drug injection conditions and transmits a control signal to the drug injector 100. Here, the rate-based injection sequence is not set using the drug injection conditions, but may be directly selected by the user via the user terminal 40, or may be calculated and received via an external computing device based on the user's past use of the drug injection device.
[0064] The user terminal 40 may be embodied as a computer or a mobile terminal that can connect to the drug injection device 10 via wireless communication. Here, the computer may include, for example, a notebook computer, desktop computer, or laptop computer equipped with a web browser, and the mobile terminal may include, for example, any type of handheld-based wireless communication device, such as various smartphones, tablet PCs, or smart watches, as a wireless communication device that ensures portability and mobility. The user terminal 40 is managed by the wearer of the drug injection device 10 or a medical professional, and drug injection conditions can be set through an application running on the user terminal 40.
[0065] Drug injection device 10 can also set a rate-based infusion sequence using user input data. Here, user input data includes the user's blood glucose level or the user's dietary information. The user input data is input by the user through user terminal 40, which is communicatively connected to drug injection device 10 via communication module 300. Control unit 200 calculates drug injection conditions based on the received user input data. Then, it sets a rate-based infusion sequence corresponding to the drug injection conditions and transmits a control signal corresponding to the rate-based infusion sequence to drug injector 100.
[0066] Drug injection device (10) can also 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 through an external measurement device (50) that is communicatively connected to drug injection device (10) via communication module (300), and control unit (200) calculates drug injection conditions based on the received user's biometric data. Then, it sets a rate-based infusion sequence corresponding to the drug injection conditions and transmits a control signal corresponding to the rate-based infusion sequence to drug injector (100). Here, external measurement device (50) may be a device that senses the user's blood glucose level.
[0067] Next, with reference to FIG. 13, the process by which the drug injection device sets up a rate-based injection sequence will be described.
[0068] The drug injection device 10 can set a rate-based injection sequence using the drug injection conditions. The drug injection device 10 can further include a user input / output interface module 400, through which the drug injection conditions are input by the user. In an embodiment in which the drug injection device 10 includes the user input / output interface module 400, the user can input the drug injection conditions, etc. directly into the user input / output interface module 400 without using a separate user terminal 40, thereby controlling the operation of the drug injection device 10. In such a case, the communication module 300 can be selectively omitted.
[0069] The control unit 200 sets an injection sequence corresponding to the drug injection conditions input through the user input / output interface module 400 and transmits a corresponding control signal to the drug injector 100. Here, the rate-based injection sequence is not set using the drug injection conditions, but can 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 the external housing including the drug injection device (10) and a signal processing circuit that transmits signals generated by operation of the physical input / output buttons to the control unit (200).
[0071] Alternatively, the user input / output interface module (400) can output a UI that guides the user to input information regarding drug infusion conditions or rate-based infusion sequences through a touchscreen display.
[0072] Furthermore, in the process of setting the above-mentioned rate-based injection sequence, the control unit (200) can also set a rate-based injection sequence corresponding to the drug injection condition by referring to a table in which multiple rate-based injection sequences are stored for each drug injection condition.
[0073] FIG. 14 is a flow chart illustrating a drug injection method according to one embodiment of the present invention.
[0074] 1, 2, and 14, a drug infusion method (S100) according to one embodiment of the present invention is described. The drug infusion method (S100) includes setting a rate-based infusion sequence for operating the drug infusion device (10) in a basal infusion mode (step S110) and applying a control signal corresponding to the rate-based infusion sequence to the electroosmotic pump (step S110) (step S120). In response to the control signal, the electroosmotic pump (110) then alternately generates negative and positive pressure for each pulse block to inhale and expel the drug, thereby injecting the drug into the user (step S130). Here, the rate-based infusion sequence includes at least one pulse block that defines a voltage or current pulse to be applied to the electroosmotic pump (110) and at least one pause block that maintains a 0 V voltage or 0 A current for a predetermined time after the application of the pulse block. 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] Each stage will be explained in detail below.
[0076] In the process of setting the rate-based infusion sequence (step S110), the drug infusion device 10 can set the rate-based infusion sequence using drug infusion conditions, and various embodiments can be used depending on when the drug infusion conditions are input. Here, the drug infusion conditions include a drug infusion duration and a drug infusion rate, or a drug infusion amount and a drug infusion duration.
[0077] Drug injection device 10 can receive drug injection conditions input from a user via user terminal 40, which is communicatively connected to drug injection device 10 via communication module 300. Control unit 200 then sets a rate-based injection sequence corresponding to the drug injection conditions and transmits a corresponding control signal to drug injector 100. Here, the rate-based injection sequence is not set using the drug injection conditions, but can be directly selected by the user via user terminal 40.
[0078] Additionally, drug injection device 10 may receive drug injection conditions input from the user using user input / output interface module 400, and control unit 200 may set a rate-based injection sequence corresponding to the drug injection conditions and transmit a control signal to drug injector 100. Here, the rate-based injection sequence may not be set using the drug injection conditions, but may be directly selected by the user through user input / output interface module 400.
[0079] Drug injection device (10) can also 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 by the user through user terminal (40) that is communicatively connected to drug injection device (10) via communication module (300). Control unit (200) calculates drug injection conditions based on the received user input data. Then, it sets a rate-based infusion sequence corresponding to the drug injection conditions and transmits a control signal corresponding to the rate-based infusion sequence to drug injector (100).
[0080] Drug injection device (10) can also set a rate-based injection sequence using the user's biometric data. Here, the user's biometric data includes the user's blood glucose information. The user's biometric data is received through external measurement device (50) communicatively connected to drug injection device (10) via communication module (300), and control unit (200) calculates drug injection conditions based on the received user's biometric data. Then, the control unit (200) sets a rate-based injection sequence corresponding to the drug injection conditions and transmits a control signal corresponding to the rate-based injection sequence to drug injector (100). Here, external measurement device (50) may be a device that senses the user's blood glucose level.
[0081] Meanwhile, in the process of setting a rate-based injection sequence, the control unit (200) can set a rate-based injection sequence corresponding to the drug injection condition by referring to a table in which multiple rate-based injection sequences are stored for each drug injection condition.
[0082] Then, in the process of applying a control signal to the electroosmotic pump (step S120), the control signal corresponding to the rate-based injection sequence may include a voltage pulse pair including a forward voltage pulse and a reverse voltage pulse or a current pulse pair including a forward current pulse and a reverse current pulse in pulse block units. Through such control signal, the electroosmotic pump generates negative and positive pressure alternately for each pulse block, and performs the operation of inhaling and exhaling (step S130), thereby injecting the drug into the user.
[0083] A method according to an embodiment of the present invention may be embodied in the form of a recording medium containing computer-executable commands, such as program modules executed by the computer. A computer-readable medium may be any available medium accessible by a computer, including both volatile and nonvolatile media, removable and non-removable media. A computer-readable medium may also include computer storage media. A computer storage medium includes both volatile and nonvolatile, removable and non-removable media embodied in any method or technology for storage of information, such as computer-readable commands, data structures, program modules, or other data.
[0084] Additionally, although the methods and systems of the present invention have been described in connection with particular embodiments, some or all of their components or operations may be implemented using a computer system having a general-purpose hardware architecture.
[0085] Those skilled in the art will understand that the present invention can be easily modified into other specific forms based on the above description without changing the technical idea or essential characteristics of the present invention. Therefore, the above-described embodiments should be understood to be illustrative in all respects and not limiting. The scope of the present invention is defined by the claims set forth below, and all modifications and variations derived from the meaning and scope of the claims and their equivalents should be construed as being within the scope of the present invention.
[0086] The scope of the present application is indicated by the claims that follow rather than by the above detailed description, and all modifications and variations that fall within the meaning and scope of the claims and their equivalents should be construed as being included within the scope of the present application.
Claims
1. In a drug injection device, A drug injector that electrochemically drives an electroosmotic pump to inhale a drug from a drug reservoir and then ejects the inhaled drug into an injection target; and a controller that outputs a control signal to the drug injector corresponding to a rate-based infusion sequence that operates the electroosmotic pump in a basal infusion mode; The rate-based injection sequence comprises: The electroosmotic pump includes at least one pulse block that defines a voltage pulse or a current pulse to be applied to the electroosmotic pump, and at least one rest block that maintains a 0 V voltage or a 0 A current for a predetermined time after application of the pulse block, each of the pulse blocks defines a pair of pulse signals to be applied to the electroosmotic pump, the pulse signals including a forward pulse and a reverse pulse that alternately generate negative and positive pressures; The electroosmotic pump alternately generates negative and positive pressure for each pulse block to inhale and expel the drug.
2. 10. The drug injection device of claim 1, The rate-based injection sequence comprises: A plurality of pulse blocks are arranged to satisfy a drug infusion rate according to drug infusion conditions including a drug infusion period and a drug infusion rate, A drug injection 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 injection period.
3. 10. The drug injection device of claim 1, The rate-based injection sequence comprises: The plurality of pulse blocks and pause blocks are arranged for a unit time, The control unit A drug infusion device that provides the rate-based infusion sequence repeatedly during the drug infusion period.
4. 3. The drug injection device of claim 2, The rate-based injection sequence comprises: A drug infusion device configured such that the duration of each pause block is less than the recommended pause period.
5. 3. The drug injection device of claim 2, The rate-based injection sequence comprises: A drug injection device, wherein the plurality of pulse blocks are arranged so that the pulse block that supplies the most drug is output first.
6. 10. The drug injection device of claim 1, The rate-based injection sequence comprises: M pulse blocks (M is a natural number equal to or smaller than N) are selected from N pulse blocks (N is a natural number) that supply different amounts of drugs according to drug injection conditions, and The drug infusion conditions include a drug infusion period and a drug infusion rate; A drug injection device, wherein the sum of the durations of the selected M pulse blocks and the durations of the plurality of pause blocks placed after each pulse block is set to correspond to the drug injection period.
7. 10. The drug injection device of claim 1, The rate-based injection sequence includes: A drug injection device in which the M pulse blocks are set so that the total number of times each selected pulse block is used is a predetermined number or a maximum number while satisfying the drug injection rate of the drug injection conditions, and so that the duration of the pause block placed after each pulse block is less than the recommended pause period.
8. 3. The drug injection device of claim 2, The rate-based injection sequence comprises: A drug injection device in which the arrangement of pulse blocks and pause blocks assigned to each segment is set according to the segments into which the drug injection period is divided into predetermined time units, so that the drug injection rate is the same for some segments and different for other segments.
9. 10. The drug injection device of claim 1, One of the pulse blocks and one of the pause blocks are formed into one group, and the duration of the group is set to a first time; The duration of the pause block is: The drug infusion device is set to a second time equal to the first time minus the duration of the pulse block.
10. 10. The drug injection device of claim 1, The pair of pulse signals It consists of a voltage pulse pair including a forward voltage pulse and a reverse voltage pulse, and includes a stabilization pulse that maintains a 0V voltage for a predetermined time after the application of the forward voltage pulse and the reverse voltage pulse, or A drug injection device comprising a current pulse pair including a forward current pulse and a reverse current pulse, and including a stabilization pulse that maintains a 0 A current for a predetermined period of time after the application of the forward current pulse and the reverse current pulse.
11. 10. The drug injection device of claim 1, The electroosmotic pump comprises: a driving unit that is electrochemically driven by the control signal and alternately generates positive pressure and negative pressure; and The drug injection device includes a chamber that draws in a drug from a drug source in response to the pressure of the drive unit and then discharges the drug into the insertion unit.
12. 10. The drug injection device of claim 1, The drug injection device comprises: receiving drug infusion conditions from a user terminal or a user input / output interface module; The control unit The control signal is output using a rate-based infusion sequence corresponding to the drug infusion condition, A drug infusion device, wherein the drug infusion conditions include a drug infusion period and a drug infusion rate.
13. 10. The drug injection device of claim 1, The drug injection device comprises: receiving user input data from a user terminal; The control unit A drug injection condition is calculated based on the user input data, and the control signal is output using a rate-based injection sequence corresponding to the drug injection condition. the user input data includes a user's blood glucose level, user activity information, or user diet information; A drug infusion device, wherein the drug infusion conditions include a drug infusion period and a drug infusion rate.
14. 10. The drug injection device of claim 1, The drug injection device comprises: receiving biometric data of the user from an external measurement device; The control unit A drug injection condition is calculated based on the biometric data of the user, and the control signal is output using a rate-based injection sequence corresponding to the drug injection condition. the user's biometric data includes user's blood glucose information or user's activity information; A drug infusion device, wherein the drug infusion conditions include a drug infusion period and a drug infusion rate.
15. 15. The drug injection device according to any one of claims 12 to 14, A drug injection device, wherein the control unit refers to a table in which multiple rate-based injection sequences are stored for each drug injection condition, and sets a rate-based injection sequence corresponding to the drug injection condition.
16. 10. The drug injection device of claim 1, The drug injection device comprises: receiving a rate-based injection sequence set by a user terminal or a user input / output interface module; The control unit A drug infusion device that utilizes the rate-based infusion sequence to output the control signal.
17. 10. The drug injection device of claim 1, The drug infusion device, wherein the rate-based infusion sequence is calculated and received via an external computing device based on a user's past drug infusion device usage history.
18. 1. A method for injecting a drug using a drug infusion device including an electroosmotic pump, comprising: setting a rate-based infusion sequence that operates the drug infusion device in a basal infusion mode; applying a control signal to the electroosmotic pump corresponding to the rate-based injection sequence; and In response to the control signal, the electroosmotic pump alternately generates negative and positive pressure for each pulse block to inhale and expel the drug, The rate-based injection sequence comprises: The electroosmotic pump includes at least one pulse block that defines a voltage pulse or a current pulse to be applied to the electroosmotic pump, and at least one rest block that maintains a 0 V voltage or a 0 A current for a predetermined time after application of the pulse block, A drug injection method for a drug injection device, wherein each pulse block defines a pair of pulse signals including a forward pulse and a reverse pulse that are applied to the electroosmotic pump and generate alternating negative and positive pressures.
19. 20. The drug injection method for a drug injection device according to claim 18, The step of configuring the rate-based injection sequence comprises: A drug injection method for a drug injection device, comprising arranging a plurality of pulse blocks that satisfy a drug injection rate according to drug injection conditions including a drug injection period and a drug injection rate, and setting the sum of the durations of the plurality of pulse blocks and the durations of a plurality of pause blocks that are arranged after the pulse blocks to correspond to the drug injection period.
20. 20. The drug injection method for a drug injection device according to claim 18, The step of configuring the rate-based injection sequence comprises: A drug injection method for a drug injection device, which arranges the plurality of pulse blocks and pause blocks in a unit time to set the rate-based injection sequence.
21. 20. The drug injection method for a drug injection device according to claim 19, The step of configuring the rate-based injection sequence comprises: A drug injection method for a drug injection device, wherein the duration of each pause block is set to be less than a recommended pause period.
22. 20. The drug injection method for a drug injection device according to claim 19, The step of configuring the rate-based injection sequence comprises: A drug injection method for a drug injection device, which sets the rate-based injection sequence by arranging the plurality of pulse blocks so that the pulse block that supplies the greatest amount of drug is output first.
23. 20. The drug injection method for a drug injection device according to claim 18, The step of configuring the rate-based injection sequence comprises: setting the rate-based infusion sequence by arranging M pulse blocks (M is a natural number equal to or smaller than N) selected from N pulse blocks (N is a natural number) that supply different amounts of drugs according to drug infusion conditions; The drug infusion conditions include a drug infusion period and a drug infusion rate; A drug injection method for a drug injection device, wherein the rate-based injection sequence is set so that the sum of the durations of the selected M pulse blocks and the durations of multiple pause blocks placed after each pulse block corresponds to the drug injection period.
24. 24. The drug injection method for a drug injection device according to claim 23, The step of configuring the rate-based injection sequence comprises: A drug injection method for a drug injection device, which sets the rate-based injection sequence so that the M pulse blocks satisfy the drug injection rate of the drug injection conditions, the total number of times each selected pulse block is used is a preset number or a maximum number, and the duration of the pause block placed after each pulse block is less than a recommended pause period.
25. 20. The drug injection method for a drug injection device according to claim 19, The step of configuring the rate-based injection sequence comprises: A drug injection method for a drug injection device, in which the arrangement of pulse blocks and pause blocks assigned to each segment is set according to the segments into which the drug injection period is divided in predetermined time units, so that the drug injection rate is the same for some segments and different for other segments.
26. 20. The drug injection method for a drug injection device according to claim 18, The step of configuring the rate-based injection sequence comprises: A drug injection method for a drug injection device, which sets the rate-based injection sequence by adjusting the magnitude and duration of the pair of voltage pulse signals or the magnitude and duration of the pair of current signals so that the amount of drug inhaled and expelled by the pair of voltage pulse signals or the pair of current pulse signals is the same.
27. 20. The drug injection method for a drug injection device according to claim 18, The pair of pulse signals It consists of a voltage pulse pair including a forward voltage pulse and a reverse voltage pulse, and includes a stabilization pulse that maintains a 0V voltage for a predetermined time after the application of the forward voltage pulse and the reverse voltage pulse, or A drug injection method for a drug injection device, comprising a current pulse pair including a forward current pulse and a reverse current pulse, and including a stabilization pulse that maintains a 0 A current for a predetermined time after the application of the forward current pulse and the reverse current pulse.
28. 20. The drug injection method for a drug injection device according to claim 18, The step of configuring the rate-based injection sequence comprises: the drug infusion device sets a rate-based infusion sequence corresponding to drug infusion conditions received from a user terminal or a user input / output interface module; A drug injection method for a drug injection device, wherein the drug injection conditions include a drug injection period and a drug injection rate.
29. 20. The drug injection method for a drug injection device according to claim 18, The step of configuring the rate-based injection sequence comprises: The drug injection device calculates the drug injection conditions based on user input data received from a user terminal, and sets a rate-based injection sequence corresponding to the drug injection conditions; The user input data includes a blood glucose level of the user and activity information of the user; A drug injection method for a drug injection device, wherein the drug injection conditions include a drug injection period and a drug injection rate.
30. 20. The drug injection method for a drug injection device according to claim 18, The step of configuring the rate-based injection sequence comprises: The drug injection device calculates the drug injection conditions based on the user's biometric data received from an external measurement device, and sets a rate-based injection sequence corresponding to the drug injection conditions; the user's biometric data includes user's blood glucose information or user's activity information; A drug injection method for a drug injection device, wherein the drug injection conditions include a drug injection period and a drug injection rate.
31. 31. A drug injection method for a drug injection device according to any one of claims 28 to 30, The step of configuring the rate-based injection sequence comprises: A drug injection method for a drug injection device, which refers to a table in which a plurality of speed-based injection sequences are stored for each drug injection condition, and sets a speed-based injection sequence corresponding to the drug injection condition.
32. 20. The drug injection method for a drug injection device according to claim 18, The step of configuring the rate-based injection sequence comprises: A drug injection method for a drug injection device, comprising receiving a rate-based injection sequence set by a user terminal or a user input / output interface module and setting the rate-based injection sequence.
33. 20. The drug injection method for a drug injection device according to claim 18, The step of configuring the rate-based injection sequence comprises: A drug injection method for a drug injection device, which receives a rate-based injection sequence calculated based on the user's past usage history of the drug injection device via an external computing device and sets the rate-based injection sequence.
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