Drug delivery device and method of operating the same

Abstract

To provide a medicine delivery device to be an in vivo insertion type device controlling medicine discharge on the basis of light stimulus, and an operation method for the same.SOLUTION: A medicine delivery device according to the current invention is a medicine delivery device (Drug Delivery Device) having: a light emitting part which is arranged in the body and outputs light by a control signal; a medicine carrier (a drug reservoir) discharging medicine by responding to the light from the light emitting part; a photosensitive part detecting light passing the medicine carrier; and a control part which uses a light quantity detected by the photosensitive part and monitors the degree to which the medicine carrier responds to light.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a drug delivery device and an operation method thereof, and particularly to a drug delivery device which is an implantable device for controlling drug release based on light stimulation and an operation method thereof.

Background Art

[0002] When repeated injection dosing is required, such as in the case of insulin or hormonal agents, the development of an implantable drug delivery system is required to improve patient inconvenience and high medical costs. Such a drug release implant system is roughly classified into a controlled drug release system and an activation modulated drug delivery system. The controlled drug release system is a method in which the drug is gradually released into the body mainly depending on the in-vivo degradation rate inherent to the substance, and the activation modulated drug delivery system is a method in which the drug is released while the characteristics of the drug carrier are deformed by stimuli inside and outside the body.

[0003] In recent years, the development of an activation modulated drug delivery system that does not act as a stimulus to other cells in the body and minimizes unintended reactions in the body has become an issue.

Summary of the Invention

Problems to be Solved by the Invention

[0004] The present invention has been made in view of the problems in the above-described conventional activation modulated drug delivery system, and an object of the present invention is to provide a drug delivery device which is an implantable device for controlling drug release based on light stimulation and an operation method thereof.

Means for Solving the Problems

[0005] The drug delivery device according to the present invention made to achieve the above object is a drug delivery device, comprising: a light emitting unit disposed in the body and outputting light according to a control signal; a drug reservoir that releases a drug in response to light from the light emitting unit; a photosensitive unit that detects light that has passed through the drug reservoir; and a control unit that monitors the degree to which the drug reservoir has reacted to light using the amount of light detected by the photosensitive unit.

[0006] Preferably, the control unit determines the absorbance of the drug reservoir based on the amount of light output from the light emitting unit and the amount of light detected by the photosensitive unit, and determines the degree of reaction of the drug reservoir using the absorbance. The control unit Drug carrier Preferably, based on the degree of reaction, determines the amount of drug released from the drug reservoir. Preferably, the control unit determines a change in state of the drug reservoir based on a change in absorbance of the drug reservoir over time. Preferably, the control unit controls the amount of drug released from the drug reservoir by adjusting one or a combination of two or more of the amount of light and exposure time of the light output from the light emitting unit based on the degree of reaction of the drug reservoir. Preferably, the control unit determines whether or not to replace the drug reservoir based on the degree of reaction of the drug reservoir. Preferably, the control unit controls at least one of the amount of light, exposure time, and wavelength of the light output from the light emitting unit using the control signal. Preferably, when light having an active wavelength corresponding to the drug reservoir is received from the light emitting unit, the drug reservoir releases the drug in response to the reception. When the drug reservoir contains a plurality of drugs having different active wavelengths, preferably, the drug reservoir releases the drug corresponding to the wavelength of the light received from the light emitting unit among the plurality of drugs. Preferably, the light emitting unit includes one or more light sources arranged so that light is radiated uniformly to the drug reservoir.

[0007] Preferably, the drug carrier includes any one of: a substance in which the drug is bound by a photosensitive linker; a genetically engineered cell that changes intracellular physiology by light to secrete the drug; a photothermomechanical substance that releases the drug using a substance that generates heat or expands by light; and a photovoltaic material that changes its magnetic properties by light to secrete the drug. Preferably, the drug carrier is received by a selective permeation membrane that blocks immunoreactive substances that may be generated when the drug delivery device is inserted into the body and allows necessary substances for retaining the drug carrier and the drug to pass through arbitrarily. Preferably, the control unit transmits information regarding at least one of the reaction degree of the drug carrier, the drug release amount, and the necessity of replacing the drug carrier to an electronic device outside the drug delivery device. It further has an electrochemical sensor for detecting a target molecule, and preferably, the control unit controls the drug release amount by adjusting one or a combination of two or more of the light amount and exposure time of the light output from the light emitting unit based on the result of detecting the target molecule by the electrochemical sensor. Preferably, the control unit determines the metabolic state in the body based on the concentration of the detected target molecule, and determines whether to apply a light stimulus to the drug carrier according to the determined metabolic state in the body. The electrochemical sensor detects the blood glucose level in the body, and preferably, the control unit controls the light emitting unit to apply a light stimulus that promotes insulin secretion of the drug carrier to the drug carrier in response to the detected blood glucose level exceeding a threshold level. Preferably, the control unit controls the light output from the light emitting unit based on one or a combination of two or more of the signals received from an electronic device outside the drug delivery device and the information stored in advance. Preferably, the drug carrier includes an exchange portal through which additional drugs can be injected from outside the drug delivery device. Preferably, it further includes a heat sink pathway that discharges heat generated by the output of light from the light emitting unit to the outside of the drug delivery device when in contact with the light emitting unit.

[0008] A method for operating a drug delivery device according to the present invention made to achieve the above object is as follows. An operating method of a drug delivery device disposed in the body and having a light emitting unit, a drug carrier, a photosensitive unit, and a control unit including a processor, wherein the processor performs the following steps: Releasing a drug in response to light The Outputting light to the drug carrier The Controlling the light emitting unit; The processor performs the following steps: Monitoring the degree to which the drug carrier reacts to light using the amount of light detected by the photosensitive unit after passing through the drug carrier, wherein the light emitting unit is characterized by being disposed inside the body.

[0009] A drug delivery device according to the present invention made to achieve the above object includes a light emitting unit that outputs light based on a control signal, a drug carrier disposed inside the body that releases a drug based on the output light, a photosensitive unit that detects the light that has passed through the drug carrier, and a control unit that monitors the drug carrier based on the amount of light detected by the photosensitive unit.

[0010] Preferably, the control unit controls one or a combination of two or more of the light amount, exposure time, and wavelength output from the light emitting unit to adjust the amount of drug released from the drug carrier. Preferably, the protective biocompatible layer is disposed between the light emitting unit and the drug carrier. Preferably, the reactivity change of the drug carrier is calibrated after the drug carrier is disposed inside the body. Preferably, two or more drugs are disposed on the drug carrier, and the drug carrier arbitrarily releases one of the two or more drugs in response to the wavelength of the output light.

Advantages of the Invention

[0011] According to the drug delivery device and its operation method according to the present invention, drug release can be controlled based on light stimulation, and unintended reactions in the body can be minimized.

Brief Description of the Drawings

[0012]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Embodiments for Carrying Out the Invention

[0013] Next, specific examples of embodiments for implementing the drug delivery device and its operation method according to the present invention will be described with reference to the drawings.

[0014] When it is determined that a specific description of a known technique related to the description of the embodiment makes the gist of the present invention unnecessarily ambiguous, the detailed description thereof is omitted. The specific structural or functional description of the embodiment is disclosed for illustrative purposes only and can be changed into various forms. Therefore, the embodiment is not limited to a specific disclosed form, and the scope of this specification includes changes, equivalents or alternatives included in the technical idea. Terms such as first or second may be used to describe a plurality of components, but such terms must be interpreted only for the purpose of distinguishing one component from another component. For example, the first component can be named the second component, and similarly the second component can also be named the first component.

[0015] Singular expressions include plural expressions unless the context clearly gives a different meaning. In this specification, terms such as "including" or "having" indicate the presence of the features, numbers, steps, operations, components, parts described in the specification or combinations thereof, and should not be understood as precluding the possibility of the existence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof. Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by those of ordinary skill in the technical field to which this embodiment belongs. Generally used pre-defined terms should be interpreted to have a meaning consistent with the meaning they have in the context of the related art, and should not be interpreted as having an ideal or overly formal meaning unless clearly defined in this specification.

[0016] FIG. 1 is a block diagram for explaining the schematic configuration of a drug delivery device according to an embodiment of the present invention. Referring to FIG. 1, a drug delivery device 100 according to an embodiment of the present invention includes a light emitting unit 110, a drug carrier 120, a photosensitive unit 130, and a control unit 140. The drug delivery device 100 is an implantable device that controls drug release based on light stimulation, and is implanted in the body to continuously or repeatedly release drugs.

[0017] The light emitting unit 110 outputs light based on a control signal from the control unit 140. The light output from the light emitting unit 110 acts as a light stimulus on the drug carrier 120. Different from other stimuli using physics, chemistry, electricity, etc., the light stimulus does not act as a stimulus on other cells in the body and can minimize unintended reactions in the body. Since the wavelength, intensity, and range of light can be freely adjusted, it is applicable to various fields according to the type of cells expressing the light protein. In addition, by implanting the light emitting unit 110 in the body, various wavelengths can be utilized without being restricted. For example, the light emitting unit 110 can utilize various wavelengths from UV (ultraviolet) to IR (infrared), but is not limited thereto, and can be utilized without limitation as long as it is a wavelength that gives a light stimulus to the drug carrier 120. The light emitting unit 110 outputs light at one or more wavelengths that induce the reaction of the drug carrier 120. In other words, the light emitting unit 110 outputs light of a specific active wavelength having activity on the drug carrier 120. The light emitting unit 110 outputs light by the light amount and / or exposure time according to the control signal of the control unit 140.

[0018] The drug carrier 120 releases drugs in response to the light from the light emitting unit 110. The drug carrier 120 is a substance that absorbs the light energy delivered from the light emitting unit 110 and releases drugs into the body, and reacts to the light stimulus of a predetermined active wavelength. For example, the drug carrier 120 may include a substance in which the drug is bound to a photosensitive linker (e.g., photo-responsive polymers, etc.), a genetically engineered cell that changes intracellular physiology upon light and secretes the drug, a photosthermomechanical substance that releases the drug using a substance that at least one of generates heat or expands upon light, and a photovoltaic material that changes its magnetic properties upon light and secretes the drug. The drug carrier 120 can have a structure with a large surface area to facilitate the exchange of substances with the outside.

[0019] After that, although it will be described in detail, the drug can be released into the body through the selective permeation membrane. In this specification, the drug carrier 120 may be referred to as a therapeutic matrix, a therapeutic material, a therapeutic agent, etc. The drug refers to a substance having pharmacological activity that affects the diagnosis, treatment, alleviation, treatment, prevention of diseases, or the physiological functions of the human body. In this specification, the drug is mainly described as insulin as a substance having pharmacological activity that mainly affects the physiological functions of the human body. Insulin is a substance that must be administered continuously or repeatedly to treat, alleviate, treat, or prevent diabetes. However, the drug is not limited to insulin, and the descriptions in this specification may also apply to other drugs.

[0020] The photosensitive unit 130 detects the light that has passed through the drug carrier 120. Among the light output from the light emitting unit 110, the remaining part excluding the part used to release the drug by the drug carrier 120 is detected by the photosensitive unit 130. The photosensitive unit 130 detects the amount of light that has passed through the drug carrier 120 and transmits it to the control unit 140.

[0021] The control unit 140 monitors the degree to which the drug carrier 120 has reacted to light using the amount of light detected by the photosensitive unit 130. For example, the control unit 140 can determine the absorbance of the drug carrier 120 based on the amount of light output by the light emitting unit 110 and the amount of light detected by the photosensitive unit 130, and judge the degree of reaction of the drug carrier 120 from the determined absorbance. Since the drug is released according to the reaction of the drug carrier 120 to light stimulation, the control unit 140 can determine the amount of drug released in the drug carrier 120 based on the reaction information of the drug carrier 120. The control unit 140 controls at least one of the amount of light, exposure time, and wavelength of the light output from the light emitting unit 110 via a control signal, thereby adjusting the amount of drug released in the drug carrier 120. If the amount of drug released is less than the reference value, the control unit 140 can increase the amount of light and / or exposure time output from the light emitting unit 110. Conversely, if the amount of drug released is more than the reference value, the control unit 140 can reduce the amount of light and / or exposure time output from the light emitting unit 110.

[0022] FIG. 2 is a block diagram for explaining the operation of a drug carrier according to an embodiment of the present invention. Referring to FIG. 2, an example is shown for explaining the process in which a photoreaction occurs in the drug carrier 220 according to an embodiment of the present invention. The light emitting unit 210 includes a light source 211 arranged so that light is uniformly radiated onto the drug carrier 220. For example, the light emitting unit 210 includes light sources 211 (for example, a plurality of LEDs, etc.) arranged in one dimension or two dimensions. The light sources arranged in one dimension have an equally spaced line form, and the light sources arranged in two dimensions can have an equally spaced lattice form (for example, a triangular lattice, a square lattice, etc.).

[0023] The protective layer 213 included in the light emitting unit 210 can be a transparent substance for protecting the light source 211. The protective layer 213 does not require direct contact with the drug carrier 220 and can be biocompatible with the living body. The light-emitting unit 210 converts electrical energy into light energy and provides it to the drug carrier 220. The drug carrier 220 absorbs a part of the light energy from the light-emitting unit 210 and releases the drug, and the rest that has passed through the drug carrier 220 is transmitted to the photosensitive unit 230 and detected.

[0024] The drug carrier 220 that releases the drug in response to the light reaction is surrounded by the selective permeable membrane 240. The selective permeable membrane 240 can block various immunoreactive substances that may occur when the drug carrier 220 is inserted into the body, and prevent damage and destruction of the drug carrier 220 by the immunoreactive substances. In addition, the selective permeable membrane 240 can allow necessary substances (such as nutrients, O2, body fluid, etc.) for the survival and retention of the drug carrier 220 to pass through and be supplied to the drug carrier 220. In addition, the selective permeable membrane 240 can allow the drug released by the light reaction of the drug carrier 220 to pass through and be delivered into the body.

[0025] When the drug is released repeatedly over a long period of time, the drug carrier 220 may corrode or swell, or in the case of optogenetically designed cells, may move by itself and deviate from the designated position. However, the selective permeable membrane 240 plays an important role in preventing this and maintaining a constant drug release amount for a long time. And the selective permeable membrane 240 suppresses the structural deformation of the drug carrier 220 and enables long-term monitoring of absorbance changes. In addition, the selective permeable membrane 240 can suppress the translocation of toxic substances or malignant cells. Thus, the selective permeation membrane 240 can be a nano-porous membrane that arbitrarily allows only substances with a certain low molecular weight level to pass through.

[0026] The light-sensitive part 230 detects the amount of light that has passed through the drug carrier 220. If the drug carrier 220 absorbs light energy and reacts, the amount of light detected by the light-sensitive part 230 becomes smaller than the amount of light output from the light-emitting part 210. Using this, the degree of reaction of the drug carrier 220 can be monitored. The photoreaction in the drug carrier 220 is expressed as shown in Equation 1 below.

Equation

[0027] In the above Equation 1, A represents absorbance, P0 represents the amount of light output from the light-emitting part 210 and radiated to the drug carrier 220, and P represents the amount of light that passes through the drug carrier 220 and is detected by the light-sensitive part 230. Also, ε represents the molar absorptivity, which is a substance-specific value indicating how much light the drug carrier 220 absorbs per mole, c represents the concentration of the drug carrier 220, and l represents the optical path length through which light passes through the drug carrier 220.

[0028] In the light-emitting part 210, since light is output according to a control signal, P0 is known, and P can be detected from the light-sensitive part 230. Also, ε and l are values determined in advance by the drug carrier 220. Therefore, the concentration of the drug carrier 220 is obtained through Equation 1. Using the characteristic that the concentration of the drug carrier 220 decreases as the drug is released from the drug carrier 220, based on the concentration change obtained from the absorbance change over time, the state change of the drug carrier 220 can be determined. Moreover, since only the difference between P0 and P is utilized for drug release by the photoreaction of the drug carrier 220, the degree of reaction of the drug carrier 220 can be determined using the difference between P0 and P. Furthermore, the drug release amount can also be determined based on the degree of reaction of the drug carrier 220.

[0029] Based on the degree of reaction of the drug carrier 220, by adjusting the light quantity and / or exposure time of the light output from the light emitting unit 210, the drug release amount in the drug carrier 220 can be kept constant. Therefore, a closed-loop drug delivery device is provided that can keep the drug release amount constant for a relatively long time. If all the drugs contained in the drug carrier 220 are released and no further photoreaction occurs, a relatively large amount of light is received by the photosensitive unit 230, and the control unit thereby determines that it is necessary to replace the drug carrier 220. To more accurately monitor the photoreaction of the drug carrier 220, a calibration is performed to analyze the change in the reactivity of the drug carrier 220 based on the above formula 1 immediately after the drug carrier 220 is first inserted into the body. Structurally, for example, the light emitting unit 210, the drug carrier 220, and the photosensitive unit 230 are arranged in a straight line considering the rectilinear propagation of light, enabling the light output from the light emitting unit 210 to pass through the drug carrier 220 and reach the photosensitive unit 230.

[0030] FIG. 3 is a graph for explaining the process of monitoring a drug carrier based on absorbance according to an embodiment of the present invention. Referring to FIG. 3, the change in absorbance according to an embodiment of the present invention is exemplarily shown. As described above, the absorbance is determined based on the light quantity P0 output from the light emitting unit and provided (irradiated) to the drug carrier, and the light quantity P transmitted through the drug carrier and detected by the photosensitive unit. Since a part of the light quantity provided to the drug carrier that remains after being used for a photoreaction is detected by the photosensitive unit, the drug release amount of the drug carrier can be determined based on the value of the absorbance. In addition, the drug release amount of the drug carrier corresponds to the degree of reaction of the drug carrier to light stimulation. Also, if there is less drug remaining in the drug carrier due to long-term drug release, the light reaction of the drug carrier becomes weaker. The weaker the light reaction, the closer the amount of light P detected by the photosensitive part passing through the drug carrier approaches the amount of light P0 output from the light emitting part and delivered to the drug carrier. In other words, the absorbance gradually decreases, and based on such absorbance changes, it is possible to judge the state change of the drug carrier (for example, the concentration of the drug carrier decreases, etc.).

[0031] FIG. 4 is a diagram for explaining drug release using a plurality of wavelengths according to an embodiment of the present invention. Referring to FIG. 4, an example is shown in which a plurality of drugs are arbitrarily released based on the first wavelength λ1 and the second wavelength λ2 according to an embodiment of the present invention. According to the embodiment, the drug carrier contains a plurality of drugs, and for example, it may contain insulin and glucagon. Glucagon is a substance that acts in the opposite way to insulin. When light of the first wavelength λ1 is incident on the drug carrier, the drug carrier reacts to the light of the first wavelength λ1 and releases insulin into the body. When light of the second wavelength λ2 is incident on the drug carrier, the drug carrier reacts to the light of the second wavelength λ2 and releases glucagon into the body. In this way, by controlling the wavelength of the light output from the light emitting part, it is possible to arbitrarily provide the required drug from among a plurality of drugs. In FIG. 4, an example using two wavelengths is shown for convenience of explanation, but embodiments in which various numbers of wavelengths are used can also be applied without limitation.

[0032] FIGS. 5 and 6 are block diagrams for explaining the schematic configuration and operation of a drug delivery device and an electronic device according to an embodiment of the present invention. Referring to FIG. 5, a drug delivery device 500 according to an embodiment of the present invention includes a light emitting unit 510, a drug carrier 520, a photosensitive unit 530, a control unit 540, a power management unit 550, and a communication unit 560. For the light emitting unit 510, the drug carrier 520, the photosensitive unit 530, and the control unit 540, since the foregoing description may be similarly applicable, a more detailed description is omitted.

[0033] The power management unit 550 provides power to the drug delivery device 500 and may include a battery. In addition, it receives power wirelessly transmitted from an external electronic device 570 and provides it to the drug delivery device 500 and / or charges the battery. The communication unit 560 performs wireless communication with the external electronic device 570. For example, the communication unit 560 transmits information regarding at least one of the reaction degree of the drug carrier 520, the drug release amount, the necessity of replacing the drug carrier 520, the remaining battery amount, and the scheduled light stimulation schedule to the electronic device 570. The communication unit 560 communicates with the electronic device 570 based on various wireless communication methods such as BLE (Bluetooth (registered trademark) Low Energy), MICS (Medical Implant Communication Service), or NFC (Near Field Communication).

[0034] The electronic device 570 is a device controlled by a user in whom the drug delivery device 500 is implanted and / or a medical professional who diagnoses and treats the corresponding user, and includes, for example, various computing devices such as smartphones, tablets, laptops, and personal computers, various wearable devices such as smartwatches and smart glasses, various home appliances such as smart speakers, smart TVs, and smart refrigerators, smart cars, smart kiosks, IoT (Internet of Things) devices, and the like.

[0035] In one embodiment, the drug delivery device 500 may be a light stimulation-based artificial pancreas device implanted in a patient with diabetes. The drug carrier 520 may include optogenetically engineered pancreatic beta cells (β-cells) and be capable of secreting insulin based on the light of the activation wavelength provided by the light-emitting unit 510. Such a drug delivery device 500 has a simpler device structure compared to an electrical stimulation system, can provide quantitative stimulation for exactly the desired time, and can monitor the reactivity of beta cells in real time.

[0036] Referring to FIG. 6, an example of controlling light stimulation according to another embodiment of the present invention is shown. As an example, the drug delivery device 600 further includes a memory 650. Based on the setting information stored in the memory 650, the light stimulation output from the light-emitting unit 610 is controlled. For example, the memory 650 stores information regarding the period, light amount, exposure time, etc. of outputting light stimulation, and the light-emitting unit 610 outputs light stimulation according to the settings stored in the memory 650.

[0037] Also, the drug delivery device 600 further includes a sensor 660, and the sensor 660 can be an electrochemical sensor for detecting a target molecule. For example, the electrochemical sensor, as a kind of transducer, may include a substance (e.g., an enzyme) that chemically reacts with a target molecule (e.g., blood glucose) to generate electricity and an electrode to which the corresponding substance is applied or in contact or connection with the corresponding substance. However, the electrochemical sensor is not limited thereto.

[0038] The control unit 640 can electrochemically monitor the concentration of the target molecule in the body via the electrochemical sensor. The control unit 640 adjusts the light amount and / or exposure time of the light output from the light-emitting unit 610 based on the result of detecting the target molecule by the sensor 660. The control unit 640 determines the metabolic state in the body based on the detected concentration of the target molecule, and decides whether to apply light stimulation with the drug carrier 620 according to the determined metabolic state in the body. The metabolic state in the body is classified into a hyperglycemic state, a normal state, a hypoglycemic state, etc. For example, the sensor 660 detects the blood glucose level in the body, and when the detected blood glucose level exceeds the threshold level, the control unit 640 controls the light emitting unit 610 to apply a light stimulus that promotes insulin secretion of the drug carrier 620 to the drug carrier 620.

[0039] Also, the drug delivery device 600 applies a light stimulus by a signal received from an external electronic device 690 via the communication unit 670 to the drug carrier 620. An input from the user and / or medical personnel is received by the communication unit 670 via the electronic device 690, and a corresponding light stimulus is applied to the drug carrier 620. Also, the drug delivery device 600 may include an exchange portal 680 for periodic drug exchange or refill. When the photoreaction at the drug carrier 620 weakens or no longer occurs due to long-term drug release, a new drug can be injected into the drug carrier 620 via the exchange portal 680 without performing an operation to replace the entire drug delivery device 600. Thereby, the usage period of the drug delivery device 600 inserted into the body can be increased, and minimization of surgery can be achieved.

[0040] FIG. 7 is a diagram for explaining a heat sink pathway according to an embodiment of the present invention. Referring to FIG. 7, the light emitting unit 710 according to an embodiment of the present invention contacts the heat sink pathway 720 and transmits heat generated by light output from the light emitting unit 710 near the selective transmission membrane 730, so that it can be discharged to the outside of the drug delivery device. Therefore, it is possible to prevent malfunction or performance degradation of the drug carrier 740 due to heat generated by the light emitting unit 710. For example, the heat sink pathway 720 includes a metal with high thermal conductivity and is configured with a structure in which heat is efficiently transmitted.

[0041] FIG. 8 is a block diagram for explaining a schematic configuration of a drug delivery device according to another embodiment of the present invention. Referring to FIG. 8, a light emitting unit 823 according to an embodiment of the present invention is included in an external device 820. Regarding the power management unit, sensors, memory, etc., they are the same as those in FIGS. 5 and 6 described above, and are omitted in FIG. 8 for convenience of explanation. The external device 820 is paired with the drug delivery device 810 and is arranged adjacent to the drug delivery device 810. The communication units (813, 821) included in each of the drug delivery device 810 and the external device 820 exchange information via wireless communication. If a light stimulation is requested by the control unit 811, a control signal for the light stimulation is transmitted to the light emitting unit 823 via the corresponding wireless communication. The light output by the light emitting unit 823 under the control signal passes through the human tissue and is delivered to the drug carrier 815. Regarding the operations such as the light reaction in the drug carrier 815 and detecting the light transmitted through the photosensitive unit 817, the foregoing description can be directly applied, and thus a more detailed description is omitted.

[0042] FIG. 9 is a flowchart for explaining an operation method of a drug delivery device according to an embodiment of the present invention. The operations in FIG. 9 can change the order of some operations or omit some operations without departing from the illustrated exemplary ideas and scopes, but can also be executed in the order and manner shown in FIG. 9. The operations shown in FIG. 9 can be executed in parallel or simultaneously. One or more blocks and combinations of blocks shown in FIG. 9 can be realized by a special-purpose hardware-based computer such as a processor that performs the specified functions or a combination of special-purpose hardware and computer instructions. As an example, the operation method shown in FIG. 9 is executed by a processor included in the drug delivery device. In addition to the following description of FIG. 9, the descriptions shown in FIGS. 1 to 8 are also applicable to FIG. 9 and are included herein by reference. Therefore, the above description is not repeated here.

[0043] In step S910, the drug delivery device controls a light-emitting unit that outputs light to a drug carrier that releases a drug in response to light. In step S920, the drug delivery device monitors the degree to which the drug carrier has reacted to light using the amount of light that has passed through the drug carrier and been detected by a photosensitive unit. Here, the light-emitting unit is inserted into the body.

[0044] The drug delivery device according to an embodiment of the present invention is a closed-loop optical stimulation drug release implant system capable of simultaneously performing optical substrate stimulation and monitoring, and has fewer side effects compared to drug release implant systems that utilize other stimuli, and can monitor the drug release amount in real time with high accuracy. Therefore, it can be applied to various therapeutic devices. In addition, the drug delivery device can be utilized for the treatment of diseases that require repeated medication as needed, and can be applied to, for example, implantable medical devices in the body for the treatment of diabetes, hormone treatment devices, obesity treatment devices, and the like.

[0045] The above-described embodiments are implemented by hardware components, software components, or a combination of hardware components and software components. For example, the devices and components described in this embodiment are implemented using one or more general-purpose computers or special-purpose computers, such as, for example, a processor, a controller, an ALU (arithmetic logic unit), a digital signal processor, a microcomputer, an FPA (field programmable array), a PLU (programmable logic unit), a microprocessor, or different devices that execute instructions and respond.

[0046] Software includes a computer program, code, instructions, or a combination of one or more of them, and can configure a processing device to operate as desired or can command the processing device independently or in combination. Software and / or data can be permanently or temporarily embodied in any type of machine, component, physical device, virtual device, computer storage medium or device, or signal wave being transmitted, in order to be interpreted by a processing device or to provide instructions or data to the processing device. Software can be distributed over a computer system connected to a network and stored or executed in a distributed manner. Software and data can be stored in one or more computer-readable recording media.

[0047] The method according to this embodiment is embodied in the form of program instructions implemented via various computer means and recorded on a computer-readable recording medium. The recording medium includes program instructions, data files, data structures, etc. alone or in combination. The recording medium and the program instructions may be specially designed and configured for the purpose of the present invention, or may be known and usable to those skilled in the art of computer software technology.

[0048] Examples of computer-readable recording media include magnetic media such as hard disks, floppy (registered trademark) disks, and magnetic tapes, optical recording media such as CD-ROMs, DVDs, magneto-optical media such as floptical disks, and hardware devices specially configured to store and execute program instructions such as ROMs, RAMs, flash memories, etc. Examples of program instructions include not only machine language code generated by a compiler, but also high-level language code executed by a computer using an interpreter or the like. The hardware device may be configured to operate as one or more software modules to perform the operations shown in the present invention, and vice versa.

[0049] As described above, the embodiments have been described, for example, with reference to the limited drawings. However, those of ordinary skill in the art can apply various technical modifications and variations based on the above description. For example, the described techniques may be performed in an order different from the described method, and / or the components of the described system, structure, device, circuit, etc. may be combined or assembled in a form different from the described method, and appropriate results can be achieved even if they are replaced or substituted by other components or equivalents.

Explanation of Reference Numerals

[0050] 100, 500, 600, 810 Drug delivery device 110, 210, 510, 610, 710, 823 Light emitting part 120, 220, 520, 620, 740, 815 Drug carrier 130, 230, 530, 630, 817 Photosensitive part 140, 540, 640, 811 Control part 211 Light source 213 Protective layer 240, 730 Selective transmission film 550 Power management part 560, 670, 821, 813 Communication part 570, 690, 820 (External) electronic device 650 Memory 660 Sensor 720 Heat sink pathway

Claims

**Claim 1** A drug delivery device, comprising: a light-emitting unit disposed in the body and outputting light in response to a control signal; a drug reservoir that releases a drug in response to light from the light-emitting unit; a photosensitive unit that detects light that has passed through the drug reservoir; a control unit that monitors the degree to which the drug reservoir reacts to light using the amount of light detected by the photosensitive unit. **Claim 2** The drug delivery device according to claim 1, wherein the control unit determines the absorbance of the drug reservoir based on the amount of light output from the light-emitting unit and the amount of light detected by the photosensitive unit, and determines the degree of reaction of the drug reservoir using the absorbance. **Claim 3** The drug delivery device according to claim 2, wherein the control unit determines the amount of drug released from the drug reservoir based on the degree of reaction of the drug reservoir. **Claim 4** The drug delivery device according to claim 2, wherein the control unit determines a change in the state of the drug reservoir based on a change in absorbance of the drug reservoir over time. **Claim 5** The drug delivery device according to claim 2, wherein the control unit controls the amount of drug released from the drug reservoir by adjusting one or a combination of two or more of the amount of light and exposure time of the light output from the light-emitting unit based on the degree of reaction of the drug reservoir. **Claim 6** The drug delivery device according to claim 1, wherein the control unit determines whether or not to replace the drug reservoir based on the degree of reaction of the drug reservoir. **Claim 7** The drug delivery device according to claim 1, wherein the control unit controls at least one of the amount of light, exposure time, and wavelength of the light output from the light-emitting unit using the control signal. **Claim 8** The drug delivery device according to claim 1, wherein the drug reservoir releases the drug in response to reception of light having an active wavelength corresponding to the drug reservoir. **Claim 9** The drug delivery device according to claim 1, wherein when the drug reservoir contains a plurality of drugs having different active wavelengths, the drug reservoir releases the drug corresponding to the wavelength of the light received from the light-emitting unit among the plurality of drugs. **Claim 10** The drug delivery device according to claim 1, wherein the light emitting unit includes one or more light sources arranged such that light is radiated uniformly to the drug carrier.

11. The drug carrier includes a substance in which the drug is bound by a photosensitive linker, a cell designed by optogenetics that changes intracellular physiology by light and secretes the drug, a photothermal mechanical substance that releases the drug using a substance that performs at least one of generating heat or expanding by light, The drug delivery device according to claim 1, characterized in that it includes any one of a photovoltaic material whose magnetic properties are changed by light and which secretes the drug.

12. The drug carrier is received in a selective permeation membrane that blocks immunoreactive substances that may be generated when the drug delivery device is inserted into the body and allows necessary substances for holding the drug carrier and the drug to pass through arbitrarily. The drug delivery device according to claim 1, characterized in that.

13. The control unit is characterized in that it transmits information regarding at least one of the reaction degree of the drug carrier, the amount of drug released, and the necessity of replacing the drug carrier to an electronic device outside the drug delivery device. The drug delivery device according to claim 1.

14. It further includes an electrochemical sensor for detecting a target molecule, The control unit controls the amount of drug released by adjusting one or a combination of two or more of the light amount and exposure time of the light output from the light emitting unit based on the result of detecting the target molecule with the electrochemical sensor. The drug delivery device according to claim 1, characterized in that.

15. The control unit determines the metabolic state in the body based on the concentration of the detected target molecule, and determines whether or not to apply a light stimulus to the drug carrier according to the determined metabolic state in the body. The drug delivery device according to claim 14, characterized in that.

16. The electrochemical sensor detects the blood glucose level in the body, The control unit controls the light emitting unit so as to apply a light stimulus that promotes insulin secretion of the drug carrier to the drug carrier in response to the detected blood glucose level exceeding a threshold level. The drug delivery device according to claim 14, characterized in that.

17. The drug delivery device according to claim 1, wherein the control unit controls the light output from the light emitting unit based on one or a combination of two or more of the signals received from an electronic device outside the drug delivery device and the information stored in advance.

18. The drug delivery device according to claim 1, wherein the drug carrier includes an exchange portal through which additional drugs from outside the drug delivery device can be injected.

19. The drug delivery device according to claim 1, further comprising a heat sink pathway that discharges heat generated by light output from the light emitting unit in contact with the light emitting unit to the outside of the drug delivery device.

20. A method of operating a drug delivery device disposed in the body and having a light emitting unit, a drug carrier, a photosensitive unit, and a control unit including a processor, a step of controlling, by the processor, the light emitting unit that outputs light to the drug carrier that releases a drug in response to light; a step of monitoring, by the processor, the degree to which the drug carrier reacts to light using the amount of light detected by the photosensitive unit after passing through the drug carrier, and having, The light emitting unit is disposed in the body, which is a method of operating a drug delivery device.

21. a light emitting unit that outputs light based on a control signal; a drug carrier disposed in the body and releasing a drug based on the output light; a photosensitive unit that detects the light that has passed through the drug carrier; a drug delivery device comprising a control unit that monitors the drug carrier based on the amount of light detected by the photosensitive unit.

22. The drug delivery device according to claim 21, wherein the control unit controls one or a combination of two or more of the amount of light, exposure time, and wavelength output from the light emitting unit to adjust the amount of drug released from the drug carrier.

23. The drug delivery device according to claim 21, wherein the biocompatible protective layer is disposed between the light emitting unit and the drug carrier.

24. The drug delivery device according to claim 21, wherein the reactive change of the drug carrier is calibrated after the drug carrier is disposed in the body.

25. Two or more drugs are disposed in the drug carrier, The drug delivery device according to claim 21, wherein the drug carrier arbitrarily releases one of the two or more drugs in response to the wavelength of the output light.

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