Drug delivery devices and methods of operating drug delivery devices

Abstract

A drug delivery device and a method of operating a drug delivery device are provided. The drug delivery device includes a light emitter disposed in a body to emit light based on a control signal, a drug reservoir configured to react to the light emitted from the light emitter and release a drug, a photosensor configured to sense the light passing through the drug reservoir, and a controller configured to monitor a degree to which the drug reservoir reacts to the light based on an amount of the light sensed by the photosensor.

Description

[0001] This application claims the benefit of Korean Patent Application No. 10-2020-0100663, filed on August 11, 2020, with the Korean Intellectual Property Office, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

[0002] The following description relates to a drug delivery device and a method of operating the drug delivery device. Background Technology

[0003] When insulin or hormone preparations require repeated injections, implantable drug delivery systems are needed to avoid inconvenience and high medical costs. Such implantable drug delivery systems can be broadly classified into controlled drug release systems and activation-modulated drug delivery systems. Controlled drug release systems primarily release drugs slowly into the body based on the inherent degradation rate of substances within the body, while activation-modulated drug delivery systems release drugs in response to changes in the properties of the drug carrier caused by stimuli from within and outside the body. Summary of the Invention

[0004] The present invention is provided in a brief form to introduce the choice of concepts further described in the following detailed description. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter.

[0005] In one general aspect, a drug delivery device is provided, the drug delivery device comprising: a light emitter disposed within the body to emit light based on a control signal; a drug reservoir configured to: respond to light emitted from the light emitter and release a drug; a photoelectric sensor configured to: sense light passing through the drug reservoir; and a controller configured to: monitor the degree to which the drug reservoir responds to light based on the amount of light sensed by the photoelectric sensor.

[0006] The controller can be configured to determine the absorbance of the drug reservoir based on the amount of light emitted from the light emitter and the amount of light sensed by the photoelectric sensor, and to determine the degree to which the drug reservoir responds to light based on the absorbance.

[0007] The controller can be configured to determine the amount of drug released from the drug reservoir based on the degree to which the drug reservoir responds to light.

[0008] The controller can be configured to determine changes in the state of the drug reservoir based on changes in the absorbance of the drug reservoir over time.

[0009] The controller can be configured to control the amount of drug released from the drug reservoir by adjusting one or more of the amount of light emitted from the light emitter and the exposure time based on the degree to which the drug reservoir responds to light.

[0010] The controller can be configured to determine whether to replace the drug reservoir based on the degree to which the drug reservoir responds to light.

[0011] The controller can be configured to control any one or any combination of the amount, wavelength, and exposure time of light emitted from the light emitter based on control signals.

[0012] The drug reservoir can be configured to release a drug in response to receiving light with an active wavelength corresponding to the drug reservoir from a light emitter.

[0013] The drug reservoir can be configured to release a drug that corresponds to the wavelength of light received from a light emitter, from among a variety of drugs containing different active wavelengths.

[0014] A light emitter may include at least one light source arranged to emit light uniformly.

[0015] Drug reservoirs may include one of the following: a substance coupled to a drug via a photosensitive connector; a photogenerated cell that secretes a drug in response to changes in intracellular physiological function caused by light; a photothermal mechanical substance that releases a drug using a substance that generates heat or expands through light; and a photovoltaic substance that secretes a drug in response to changes in magnetic properties caused by light.

[0016] The drug reservoir may be housed in a selective membrane configured to: block immune response substances generated in response to insertion of the drug delivery device into the body, allow the drug to pass selectively, and allow substances for maintaining the drug reservoir to pass selectively.

[0017] The controller can be configured to send information to an external electronic device regarding the degree to which the drug reservoir responds to light, the amount of drug released, and whether the drug reservoir needs to be replaced, or any combination thereof.

[0018] The drug delivery device may include: an electrochemical sensor configured to sense a target molecule, wherein the controller is configured to control the amount of drug released by adjusting any one or any combination of the amount of light emitted from a light emitter and the exposure time based on the result obtained by sensing the target molecule with the electrochemical sensor.

[0019] The controller can be configured to determine the metabolic state in vivo based on the concentration of the sensed target molecule, and to determine whether to apply light stimulation to the drug reservoir based on the determined metabolic state.

[0020] An electrochemical sensor can be configured to sense blood glucose levels in the body, and a controller can be configured to: in response to the sensed blood glucose level exceeding a threshold level, control a light emitter to apply light stimulation that promotes the secretion of insulin from a drug reservoir.

[0021] The controller can be configured to control the light emitted from the light emitter based on signals received from any or any combination of electronic devices outside the drug delivery device and pre-stored information.

[0022] The drug reservoir may include a replacement inlet, through which additional drugs can be injected from outside the drug delivery device.

[0023] The drug delivery device may include a heat sink passage configured to discharge heat generated by the light emitter to the outside of the drug delivery device, the heat sink passage being in contact with the light emitter.

[0024] In another general aspect, a method of operating a drug delivery device is provided, the method comprising: controlling a light emitter to emit light into a drug reservoir, the drug reservoir being configured to respond to the light and release a drug; and monitoring the degree to which the drug reservoir responds to the light based on the amount of light passing through the drug reservoir and sensed by a photoelectric sensor, wherein the light emitter is disposed within the body.

[0025] In another general aspect, a drug delivery device is provided, the drug delivery device comprising: a light emitter that emits light based on a control signal; a drug reservoir disposed within the body and configured to release a drug based on the emitted light; a photoelectric sensor configured to sense light passing through the drug reservoir; and a controller configured to monitor the drug reservoir based on the amount of light sensed by the photoelectric sensor.

[0026] The controller can be configured to control any one or any combination of the amount, wavelength, and exposure time of light emitted from the light emitter to regulate the amount of drug released from the drug reservoir.

[0027] A protective biocompatible layer can be placed between the light emitter and the drug reservoir.

[0028] After a drug reservoir is placed in the body, changes in the reactivity of the drug reservoir can be calibrated.

[0029] Two or more drugs may be placed in a drug reservoir, and the drug reservoir may be configured to selectively release one of the two or more drugs in response to the wavelength of the emitted light.

[0030] Other features and aspects will become clear from the following detailed description, drawings, and claims. Attached Figure Description

[0031] Figure 1 An example of a drug delivery device is shown.

[0032] Figure 2 An example of a drug storage device is shown.

[0033] Figure 3 An example of processing based on absorbance monitoring of a drug reservoir is shown.

[0034] Figure 4 An example of drug release using multiple wavelengths is shown.

[0035] Figure 5 and Figure 6 Examples of the operation of drug delivery devices and electronic devices are shown.

[0036] Figure 7 An example of a heatsink path is shown.

[0037] Figure 8 Another example of a drug delivery device is shown.

[0038] Figure 9 An example of a method for operating a drug delivery device is shown.

[0039] Throughout the accompanying drawings and detailed embodiments, unless otherwise described or provided, the same reference numerals will be understood to denote the same elements, features, and structures. The drawings may not be to scale, and for clarity, illustration, and convenience, the relative sizes, proportions, and depictions of elements in the drawings may be exaggerated. Detailed Implementation

[0040] The following detailed embodiments are provided to aid the reader in gaining a comprehensive understanding of the methods, apparatus, and / or systems described herein. However, various changes, modifications, and equivalents of the methods, apparatus, and / or systems described herein will become apparent upon understanding this disclosure. For example, the order of operations described herein is merely illustrative and is not limited to those orders set forth herein, but may be changed as will become clear upon understanding this disclosure, except for operations that must occur in a specific order. Furthermore, for clarity and conciseness, descriptions of features known in the art may be omitted.

[0041] The features described herein may be implemented in different forms and should not be construed as limited to the examples described herein. Rather, the examples described herein have been provided merely to illustrate some of the many feasible ways of implementing the methods, apparatus, and / or systems described herein that will be clear upon understanding the disclosure of this application.

[0042] The following structural or functional descriptions of the examples disclosed in this disclosure are intended only for illustrative purposes, and the examples may be implemented in various forms. The examples are not intended to be limiting, but rather to include various modifications, equivalents, and substitutions within the scope of the claims.

[0043] Although the terms "first" or "second" are used to describe various components, the components are not limited to the terms. These terms should be used only to distinguish one component from another. For example, within the scope of the conception of this disclosure, a "first" component may be referred to as a "second" component, or similarly, a "second" component may be referred to as a "first" component.

[0044] It will be understood that when a component is referred to as being "connected to" another component, the component may be directly connected to or combined with the other component, or there may be an intermediate component.

[0045] As used herein, unless the context clearly indicates otherwise, the singular form is intended to include the plural form as well. It should also be understood that the term "comprising," when used in this specification, indicates the presence of the stated features, integrals, steps, operations, elements, components, or combinations thereof, but does not exclude the presence or addition of one or more other features, integrals, steps, operations, elements, components, and / or groups thereof.

[0046] In the following description, examples will be described in detail with reference to the accompanying drawings, and the same reference numerals in the drawings always denote the same elements.

[0047] Figure 1 An example of a drug delivery device 100 is shown.

[0048] Reference Figure 1 The drug delivery device 100 includes a light emitter 110, a drug reservoir 120, a photoelectric sensor 130, and a controller 140. The drug delivery device 100 may be an implantable device configured to control drug release based on light stimulation, and may be implanted in the body to continuously or repeatedly release drugs.

[0049] The light emitter 110 can emit light based on a control signal from the controller 140. The light emitted from the light emitter 110 can act as photostimulation for the drug reservoir 120. Since photostimulation does not stimulate other cells in the body, unlike other stimuli based on physical, chemical, and electrical processes, it minimizes unintended reactions within the body. Furthermore, because the wavelength, intensity, and range of the light are freely controllable, photostimulation can be applied to various fields based on the type of photoprotein expressing cell. The light emitter 110 can be implanted in the body, allowing various wavelengths to be used without limitation. For example, the light emitter 110 can utilize various wavelengths (e.g., wavelengths ranging from ultraviolet (UV) to infrared (IR), however, examples are not limited to this. All wavelengths capable of applying photostimulation to the drug reservoir 120 can be used without limitation.

[0050] The light emitter 110 can emit light having at least one wavelength that causes a response in the drug reservoir 120. For example, the light emitter 110 can emit light having a predetermined active wavelength to the drug reservoir 120. The light emitter 110 can emit light based on the amount of light and / or exposure time according to a control signal from the controller 140.

[0051] Drug reservoir 120 is responsive to light emitted from light emitter 110 and can release a drug. Drug reservoir 120 can be, for example, a substance that absorbs light energy emitted from light emitter 110 and releases the drug into the body, and is responsive to stimulation by light having a predetermined active wavelength. Drug reservoir 120 may include at least one of the following: a substance conjugated to a drug via a photosensitive linker (e.g., a photo-responsive polymer); an optogenetically engineered cell that secretes a drug in response to changes in intracellular physiological function induced by light; a photothermomechanical material that releases a drug using a substance that generates heat or expands through light; and a photovoltaic material that secretes a drug in response to changes in magnetic properties induced by light. Drug reservoir 120 may have a structure with a large surface area to facilitate exchange with external substances. The drug can be released into the body through a selective membrane, as will be described below. In this specification, the drug reservoir 120 may also be referred to as a "therapeutic matrix", "therapeutic substance" or "therapeutic agent".

[0052] A drug can refer to a substance having pharmacological activity that affects the diagnosis, treatment, relief, cure, and prevention of a disease or the physiological function of the body (such as a human or animal body). In the following description, reference is primarily made to the human body; however, it is understood that "human body" generally refers to any living organism. The term "drug" as used herein refers to a substance having pharmacological activity that affects the physiological function of the human body (such as insulin). Insulin can be a substance that needs to be administered continuously or repeatedly to treat, relieve, cure, or prevent diabetes. However, drugs are not limited to insulin, and the description in this specification may also apply to other drugs.

[0053] The photoelectric sensor 130 can sense light passing through the drug reservoir 120. The photoelectric sensor 130 can sense the amount of light emitted from the light emitter 110, excluding the portion used to release the drug through the drug reservoir 120. The photoelectric sensor 130 can sense the amount of light passing through the drug reservoir 120 and can transmit the sensed amount of light to the controller 140.

[0054] The controller 140 can monitor the degree to which the drug reservoir 120 responds to light based on the amount of light sensed by the photoelectric sensor 130. For example, the controller 140 can determine the absorbance of the drug reservoir 120 based on the amount of light emitted from the light emitter 110 and the amount of light sensed by the photoelectric sensor 130, and can determine the degree to which the drug reservoir 120 responds to light based on the determined absorbance. Since a drug can be released through the response of the drug reservoir 120 to light stimulation, the controller 140 can determine the amount of drug to be released from the drug reservoir 120 based on the response information of the drug reservoir 120.

[0055] The controller 140 can control one or more of the amount, wavelength, and exposure time of light emitted from the light emitter 110 based on control signals to regulate the amount of drug released from the drug reservoir 120. For example, when the amount of drug released from the drug reservoir 120 is less than a reference value, the controller 140 can increase the amount of light emitted from the light emitter 110 and the exposure time. When the amount of drug released is greater than a reference value, the controller 140 can decrease the amount of light emitted from the light emitter 110 and the exposure time.

[0056] Figure 2 An example of a drug storage device 220 is shown.

[0057] Figure 2 An example of a process in which a photoreaction occurs in drug reservoir 220 is shown.

[0058] The light emitter 210 may include a light source 211 (e.g., at least one light source) arranged to allow light to be uniformly delivered to the drug reservoir 220. For example, the light emitter 210 may include a one-dimensional or two-dimensional arrangement of light sources 211 (e.g., light-emitting diodes (LEDs)). A one-dimensional arrangement of light sources may be in the form of equally spaced lines, and a two-dimensional arrangement of light sources may be in the form of equally spaced grids (e.g., triangular grids or square grids).

[0059] The protective layer 213 included in the light emitter 210 may be a transparent material that protects the light source 211. The protective layer 213 does not need to directly contact the drug reservoir 220, therefore the protective layer 213 is biocompatible. In one example, the protective layer 213 may be a protective biocompatible layer and may be disposed between the light emitter and the drug reservoir.

[0060] The light emitter 210 can convert electrical energy into light energy and provide the light energy to the drug reservoir 220. The drug reservoir 220 can absorb a portion of the light energy received from the light emitter 210 and release the drug. The remaining light energy passing through the drug reservoir 220 can be transmitted to and sensed by the photoelectric sensor 230.

[0061] A drug reservoir 220 that releases a drug in response to a photoreaction may be encapsulated (or contained) by a selective membrane 240. The selective membrane 240 blocks various immune response substances that may be generated when the drug reservoir 220 (or drug delivery device 100) is implanted in the body, preventing damage and destruction of the drug reservoir 220 due to these substances. Furthermore, the selective membrane 240 allows the passage of substances necessary for the survival and maintenance of the drug reservoir 220 (e.g., nutrients, O2, or body fluids), enabling the supply of these substances to the drug reservoir 220. Additionally, the selective membrane 240 allows the passage of the drug released due to the photoreaction of the drug reservoir 220, enabling the drug to be delivered into the body. For example, when the drug is repeatedly released over a relatively long period, the drug reservoir 220 may be eroded or swollen, and photoengineered cells may migrate and deviate from their intended location. In this example, by preventing these phenomena, the selective membrane 240 performs the important function of maintaining a constant amount of the drug to be released. Furthermore, the selective membrane 240 can inhibit structural deformation of the drug reservoir 220, enabling monitoring of absorbance changes over a relatively long period. Additionally, the selective membrane 240 can inhibit the translocation of toxic substances or malignant cells. The selective membrane 240 can be a nanoporous membrane that selectively allows substances with relatively small molecular weights to pass through.

[0062] The photoelectric sensor 230 can sense the amount of light passing through the drug reservoir 220. When the drug reservoir 220 absorbs and responds to light energy, the amount of light sensed by the photoelectric sensor 230 can become less than the amount of light emitted from the light emitter 210, which allows the degree of response of the drug reservoir 220 to be monitored. The photoreaction in the drug reservoir 220 can be represented by Equation 1 shown below.

[0063] Equation 1

[0064]

[0065] In Equation 1, A represents absorbance, P0 represents the amount of light emitted from light emitter 210 and transmitted to drug reservoir 220, and P represents the amount of light passing through drug reservoir 220 and sensed by photoelectric sensor 230. Furthermore, ε represents molar absorptivity as a material-specific value indicating the amount of light absorbed per mol of drug reservoir 220, c represents the concentration of drug reservoir 220, and l represents the length of the optical path traversed by drug reservoir 220.

[0066] Since light is emitted from light emitter 210 based on a control signal, P0 can be known, and P can be sensed by photoelectric sensor 230. Furthermore, ε and l can correspond to predetermined values ​​based on drug reservoir 220. Therefore, the concentration of drug reservoir 220 can be obtained using Equation 1. Based on the characteristic that the concentration of drug reservoir 220 decreases as the amount of drug released from drug reservoir 220 increases, the change in the state of drug reservoir 220 can be determined based on the change in concentration due to changes in absorbance. For example, the change in the state of drug reservoir 220 can be determined based on the change in absorbance over time. Furthermore, the difference between amount P0 and amount P can be used for drug release via the light reaction of drug reservoir 220, thus the degree of reaction of drug reservoir 220 can be determined based on the difference between amount P0 and amount P. Additionally, the amount of drug released from drug reservoir 220 can be determined based on the degree of reaction of drug reservoir 220.

[0067] When the amount of light emitted from the light emitter 210 and / or the exposure time are adjusted based on the responsiveness of the drug reservoir 220, a constant amount of drug released from the drug reservoir 220 can be maintained. Therefore, a closed-loop drug delivery device capable of maintaining a constant amount of drug to be released over a relatively long period of time can be provided.

[0068] In one embodiment, the controller may determine whether to replace the drug reservoir 220 based on the degree to which the drug reservoir 220 responds to light. For example, when all the drugs contained in the drug reservoir 220 have been released and no further light response has occurred, a relatively large amount of light may be received by the photoelectric sensor 230, and the controller may determine that the drug reservoir 220 needs to be replaced.

[0069] To more accurately monitor the drug reservoir 220's response to light, calibration can be performed immediately after the drug reservoir 220 is initially inserted into the body to analyze changes in the reactivity of the drug reservoir 220 based on Equation 1. In one embodiment, changes in the reactivity of the drug reservoir 220 are calibrated after the drug reservoir 220 has been placed in the body.

[0070] Structurally, in one example, taking into account the straightness of light, the light emitter 210, the drug reservoir 220, and the photoelectric sensor 230 can be arranged in a straight line, such that light emitted from the light emitter 210 can pass through the drug reservoir 220 to reach the photoelectric sensor 230.

[0071] Figure 3 An example of processing based on absorbance monitoring of a drug reservoir is shown.

[0072] Figure 3 The change in absorbance is illustrated. As described above, absorbance can be determined based on the amount P0 of light emitted from the light emitter and transmitted to the drug reservoir, and the amount P of light passing through the drug reservoir and sensed by the photodetector. A portion of the light supplied to the drug reservoir can be used for photoreaction, and the remaining light can be sensed by the photodetector; therefore, the amount of drug released from the drug reservoir can be determined based on the absorbance value. Furthermore, the amount of drug released from the drug reservoir can correspond to the degree to which the drug reservoir responds to light stimulation.

[0073] When a small amount of drug remains in the drug reservoir due to drug release over a relatively long period, the photoreaction of the drug reservoir may weaken. As the photoreaction weakens, the amount P may become close to the amount P0. In other words, the absorbance may gradually decrease, and the change in the state of the drug reservoir (e.g., a decrease in the concentration of the drug reservoir) can be determined based on the change in absorbance.

[0074] Figure 4 An example of drug release using multiple wavelengths is shown.

[0075] exist Figure 4In this system, multiple drugs can be selectively released based on a first wavelength λ1 and a second wavelength λ2. According to an example, the drug reservoir may include multiple drugs (e.g., insulin and glucagon). Glucagon may be a substance that acts oppositely to insulin. When light with the first wavelength λ1 is incident on the drug reservoir, the reservoir reacts to the light and releases insulin into the body. When light with the second wavelength λ2 is incident on the drug reservoir, the reservoir reacts to the light and releases glucagon into the body. Therefore, by controlling the wavelength of the light emitted from the light emitter, a desired drug among multiple drugs can be selectively delivered. Although for ease of description... Figure 4 Two wavelengths are shown, but there is no limit to the number of wavelengths that can be used.

[0076] Figure 5 and Figure 6 Examples of the operation of drug delivery devices and electronic devices are shown.

[0077] Reference Figure 5 The drug delivery device 500 may include a light emitter 510, a drug reservoir 520, a photoelectric sensor 530, a controller 540, a power manager 550, and a communicator 560. The above description also applies to the light emitter 510, the drug reservoir 520, the photoelectric sensor 530, and the controller 540, therefore, further descriptions will not be repeated here.

[0078] The power manager 550 can supply power to the drug delivery device 500 and may include a battery. Furthermore, the power manager 550 can wirelessly receive power from the electronics 570 to supply power to the drug delivery device 500 or to charge the battery. The electronics 570 may be located outside the body.

[0079] The communicator 560 can wirelessly communicate with the electronic device 570. For example, the communicator 560 can send information to the electronic device 570 regarding one or more of the following: the responsiveness of the drug reservoir 520, the amount of drug released from the drug reservoir 520, whether the drug reservoir 520 needs to be replaced, the remaining battery power, and a predetermined photostimulation schedule. The communicator 560 can communicate with the electronic device 570 based on various wireless communication schemes, such as Bluetooth Low Energy (BLE), Medical Implantable Communication Services (MICS), or Near Field Communication (NFC).

[0080] Electronic device 570 can be a device controlled by a user with an implanted drug delivery device 500 and / or by a medical professional diagnosing and treating the user's illness. Electronic device 570 may include, for example, various computing devices (such as smartphones, tablets, laptops, or personal computers (PCs)), various wearable devices (such as smartwatches or smart glasses), various home appliances (such as smart speakers, smart TVs (TVs), or smart refrigerators), smart vehicles, smart automated service terminals, or Internet of Things (IoT) devices.

[0081] The drug delivery device 500 may be a light-stimulation-based artificial pancreas implanted in a patient with diabetes. The drug reservoir 520 may include photoengineered pancreatic β cells and may secrete insulin based on light of an active wavelength (e.g., a first wavelength λ1) supplied from a light emitter 510. Optionally, the drug reservoir 520 may include, or may also include, photoengineered pancreatic α cells and may secrete glucagon based on light of an active wavelength (e.g., a second wavelength λ2) supplied from a light emitter 510. The drug delivery device 500 may have a simpler device structure than an electrical stimulation system, delivers quantitative stimulation precisely at a desired time, and allows for real-time monitoring of β-cell responsiveness.

[0082] Figure 6 An example of controlling light stimulation is shown.

[0083] In one example, the drug delivery device 600 may also include a memory 650. The light stimulation output from the light emitter 610 can be controlled based on setting information stored in the memory 650. For example, the memory 650 may store information about the period of the output light stimulation, the amount of light, and the exposure time, and the light emitter 610 may output the light stimulation based on the setting information stored in the memory 650.

[0084] Furthermore, the drug delivery device 600 may also include a sensor 660. The sensor 660 may be an electrochemical sensor configured to sense a target molecule. For example, the electrochemical sensor may be a transducer and may include a substance (e.g., an enzyme) that generates electricity through a chemical reaction with the target molecule (e.g., blood glucose) and an electrode that is applied to, in contact with, or connected to the substance. However, examples are not limited to electrochemical sensors.

[0085] The controller 640 may use an electrochemical sensor to electrochemically monitor the concentration of target molecules in the body. The controller 640 may adjust the amount of light emitted from the light emitter 610 and / or the exposure time based on the results obtained by sensing the target molecules with sensor 660. The controller 640 may determine the metabolic state in the body based on the sensed concentration of the target molecules and may determine whether to apply light stimulation to the drug reservoir 620 based on the determined metabolic state. The metabolic state may be classified as hyperglycemic, normal, and hypoglycemic. For example, sensor 660 may sense the blood glucose level in the body, and in response to the sensed blood glucose level exceeding a threshold level, the controller 640 may control the light emitter 610 to apply light stimulation that promotes insulin secretion from the drug reservoir 620 to the drug reservoir 620.

[0086] The drug delivery device 600 can apply light stimulation to the drug reservoir 620 corresponding to a signal received from an externally located electronic device 690 via a communicator 670. Input from a user and / or medical personnel can be received from the electronic device 690 via the communicator 670, and the light stimulation corresponding to the input can be applied to the drug reservoir 620. In one example, the light stimulation output from the light emitter 610 can be controlled based on both setting information stored in the memory 650 and the signal received from the externally located electronic device 690.

[0087] Furthermore, the drug delivery device 600 may include a replacement inlet 680 for periodically replacing or refilling the drug. When the photoreaction in the drug reservoir 620 weakens or no further photoreaction occurs due to drug release over a relatively long period of time, new drug can be injected into the drug reservoir 620 through the replacement inlet 680 without the need for surgery to replace the drug delivery device 600. Therefore, surgery can be minimized by extending the usage period of the implanted drug delivery device 600.

[0088] Figure 7 An example of heat sink passage 720 is shown.

[0089] Reference Figure 7 The light emitter 710 may contact the heat sink passage 720, and heat generated in response to light emission from the light emitter 710 may be transferred to a location near the selective membrane 730, allowing heat to dissipate from the drug delivery device. Therefore, performance degradation due to heat generated in the light emitter 710, or malfunction of the drug reservoir 740 due to heat generated in the light emitter 710, can be prevented. For example, the heat sink passage 720 may comprise a metal with high thermal conductivity and may be configured with a structure that efficiently transfers heat.

[0090] Figure 8 An example of a drug delivery device 810 is shown.

[0091] Reference Figure 8 The light emitter 823 may be included in the external device 820. The power manager, sensor, and memory have already been described above, and therefore, for ease of description, their descriptions will not be repeated here.

[0092] External device 820 can be positioned adjacent to drug delivery device 810 by pairing with it. The communicator 813 of drug delivery device 810 and the communicator 821 of external device 820 can exchange information wirelessly. When light stimulation is requested by controller 811, a control signal for light stimulation can be transmitted wirelessly to light emitter 823. Light emitted from light emitter 823 based on the control signal can be transmitted through human tissue to drug reservoir 815. The above description is applicable to, for example, the operation of light response in drug reservoir 815 and the sensing of light penetrating drug reservoir 815; therefore, further description of this operation will not be repeated here.

[0093] Figure 9 An example of a method for operating a drug delivery device is shown. Although Figure 9 The operations can be performed in the order and manner shown, but without departing from the spirit and scope of the illustrative examples described, the order of some operations may be changed or some operations may be omitted. Figure 9 Many of the operations shown can be performed in parallel or simultaneously. Figure 9 One or more blocks, and combinations thereof, can be executed by a computer based on dedicated hardware (such as a processor) that performs the specified function, or by a combination of dedicated hardware and computer instructions. In one example, Figure 9 The operation method can be performed by a processor included in the drug delivery device. In addition to the following... Figure 9 In addition to the description, Figures 1 to 8 The description can also be applied to Figure 9 And it is included here by reference. Therefore, the above description need not be repeated here.

[0094] In operation 910, the drug delivery device controls a light emitter to emit light onto a drug reservoir configured to respond to the light and release the drug. In operation 920, the drug delivery device monitors the degree to which the drug reservoir responds to the light based on the amount of light passing through the drug reservoir and sensed by a photoelectric sensor. The light emitter may be inserted into the body.

[0095] According to the example, the drug delivery device can be an implantable closed-loop photostimulation drug delivery system capable of simultaneously performing light-based stimulation and monitoring. The drug delivery device may have fewer side effects than implantable drug delivery systems based on other stimuli, and can monitor the amount of drug to be released in real time with high accuracy; therefore, the drug delivery device is suitable for a variety of devices used for treatment. Furthermore, the drug delivery device can be used for the treatment of disease conditions requiring on-demand repeated administration, and is suitable for, for example, implantable medical devices for treating diabetes, hormone therapy devices, or obesity treatment devices.

[0096] The controllers 140, 540, 550, 560, 640, 670, 811, 813, and 821 described herein, as well as other devices, units, modules, apparatuses, and components, are implemented by hardware components. Examples of hardware components that can be used to perform the operations described herein include, where appropriate, controllers, sensors, generators, drivers, memories, comparators, arithmetic logic units, adders, subtractors, multipliers, dividers, integrators, and any other electronic components configured to perform the operations described herein. In other examples, one or more of the hardware components performing the operations described herein are implemented by computing hardware (e.g., by one or more processors or computers). The processor or computer may be implemented by one or more processing elements, such as logic gate arrays, controllers and arithmetic logic units, digital signal processors, microcomputers, programmable logic controllers, field-programmable gate arrays, programmable logic arrays, microprocessors, or any other means or combination of means configured to respond to and execute instructions in a defined manner to achieve a desired result. In one example, the processor or computer includes or is connected to one or more memories storing instructions or software executed by the processor or computer. Hardware components implemented by the processor or computer can execute instructions or software (such as an operating system (OS) and one or more software applications running on the OS) for performing the operations described herein. The hardware components can also access, manipulate, process, create, and store data in response to the execution of the instructions or software. For simplicity, the singular terms "processor" or "computer" are used in the description of the examples described herein; however, in other examples, multiple processors or computers may be used, or a processor or computer may include multiple processing elements, or multiple types of processing elements, or both. For example, a single hardware component, or two or more hardware components, may be implemented by a single processor, or two or more processors, or a processor and a controller. One or more hardware components may be implemented by one or more processors, or a processor and a controller, and one or more other hardware components may be implemented by one or more other processors, or another processor and another controller. One or more processors, or a processor and a controller, may implement a single hardware component, or two or more hardware components.The hardware components may be any one or more with different processing configurations. Examples of different processing configurations include: a single processor, a standalone processor, a parallel processor, a single instruction single data (SISD) multiprocessor, a single instruction multiple data (SIMD) multiprocessor, multiple instruction single data (MISD) multiprocessor, multiple instruction multiple data (MIMD) multiprocessor, a controller and arithmetic logic unit (ALU), a DSP, a microcomputer, an FPGA, a programmable logic unit (PLU), a central processing unit (CPU), a graphics processing unit (GPU), a neural processing unit (NPU), or any other device capable of responding to and executing instructions in a defined manner.

[0097] The methods for performing the operations described in this application are executed by computing hardware (e.g., by one or more processors or a computer), which is implemented as the execution instructions or software described above to perform the operations performed by the methods described in this application. For example, a single operation, or two or more operations, may be executed by a single processor, or two or more processors, or a processor and a controller. One or more operations may be executed by one or more processors, or a processor and a controller, and one or more other operations may be executed by one or more other processors, or another processor and another controller. One or more processors, or a processor and a controller, may execute a single operation, or two or more operations.

[0098] Instructions or software for controlling a processor or computer to implement hardware components and perform the methods described above are written as computer programs, code segments, instructions, or any combination thereof to individually or collectively instruct or configure the processor or computer to operate as a machine or special-purpose computer to perform operations performed by the hardware components and methods described above. In one example, the instructions or software include machine code (such as machine code generated by a compiler) that is directly executed by the processor or computer. In one example, the instructions or software include at least one of a applet, dynamic link library (DLL), middleware, firmware, device driver, and application that stores methods for operating a drug delivery device. In another example, the instructions or software include high-level code that is executed by the processor or computer using an interpreter. Programmers skilled in the art can readily write instructions or software based on the block diagrams and flowcharts shown in the accompanying drawings and the corresponding descriptions in the specification, which disclose algorithms for performing operations performed by the hardware components and methods described above.

[0099] Instructions or software used to control a processor or computer to implement hardware components and perform the methods described above, along with any associated data, data files, and data structures, are recorded, stored, or fixed in, or on, one or more non-transitory computer-readable storage media. Examples of non-transitory computer-readable storage media include: read-only memory (ROM), programmable random access read-only memory (PROM), electrically erasable programmable read-only memory (EEPROM), random access memory (RAM), dynamic random access memory (DRAM), static random access memory (SRAM), flash memory, non-volatile memory, CD-ROM, CD-R, CD+R, CD-RW, CD+RW, DVD-ROM, DVD-R, DVD+R, DVD-RW, DVD+RW, DVD-RAM, BD-ROM, BD-R, BD-R LTH, BD-RE, Blu-ray or optical disc storage, hard disk drive (HDD), solid-state drive (SSD), card storage (such as multimedia cards or microcards (e.g., Secure Digital (SD) or Extreme Digital (XD))), magnetic tape, floppy disk, magneto-optical data storage device, optical data storage device, hard disk, solid-state drive, and any other device configured to store instructions or software and any associated data, data files, and data structures in a non-transitory manner, and to provide instructions or software and any associated data, data files, and data structures to a processor or computer so that the processor or computer can execute the instructions.

[0100] While this disclosure includes specific examples, it will be clear upon understanding this disclosure that various changes in form and detail may be made in these examples without departing from the spirit and scope of the claims and their equivalents. The examples described herein should be considered descriptive only and not for limiting purposes. The description of features or aspects in each example should be considered applicable to similar features or aspects in other examples. Suitable results may be achieved if the described techniques are performed in a different order, and / or if components in the described system, architecture, apparatus, or circuit are combined in a different manner, and / or replaced or supplemented by other components or their equivalents. Therefore, the scope of the disclosure is not limited by the specific embodiments but by the claims and their equivalents, and all variations within the scope of the claims and their equivalents should be construed as included in the disclosure.

Claims

1. A drug delivery device, comprising: A light emitter, installed inside the body, emits light based on control signals; A drug reservoir is configured to react to light emitted from a light emitter and release the drug. A photoelectric sensor is configured to sense light passing through the drug reservoir; and The controller is configured to monitor the degree to which the drug reservoir responds to light based on the amount of light sensed by a photoelectric sensor. The light emitter comprises multiple light sources arranged in a two-dimensional pattern. A photoelectric sensor is positioned below the light emitter, and a drug reservoir is positioned between the light emitter and the photoelectric sensor. The light emitter, drug reservoir, and photoelectric sensor are arranged in a straight line, such that light emitted from the light emitter passes through the drug reservoir to reach the photoelectric sensor. The controller is further configured to determine the absorbance of the drug reservoir based on the difference between the amount of light emitted from the light emitter and the amount of light sensed by the photoelectric sensor, and to determine the degree to which the drug reservoir responds to light based on the absorbance.

2. The drug delivery device according to claim 1, wherein, The controller is also configured to determine the amount of drug released from the drug reservoir based on the degree to which the drug reservoir responds to light.

3. The drug delivery device according to claim 1, wherein, The controller is also configured to determine changes in the state of the drug reservoir based on changes in the absorbance of the drug reservoir over time.

4. The drug delivery device according to claim 1, wherein, The controller is also configured to control the amount of drug released from the drug reservoir by adjusting one or more of the amount of light emitted from the light emitter and the exposure time based on the degree to which the drug reservoir responds to light.

5. The drug delivery device according to any one of claims 1 to 4, wherein, The controller is also configured to determine whether to replace the drug reservoir based on the degree to which the drug reservoir responds to light.

6. The drug delivery device according to any one of claims 1 to 4, wherein, The controller is also configured to control one or more of the amount, wavelength, and exposure time of light emitted from the light emitter based on control signals.

7. The drug delivery device according to any one of claims 1 to 4, wherein, The drug reservoir is also configured to release the drug in response to receiving light with an active wavelength corresponding to the drug reservoir from a light emitter.

8. The drug delivery device according to any one of claims 1 to 4, wherein, The drug reservoir is also configured to release, among a variety of drugs containing different active wavelengths, the drug corresponding to the wavelength of light received from the light emitter.

9. The drug delivery device according to any one of claims 1 to 4, wherein, The light emitter includes at least one light source arranged to emit light uniformly.

10. The drug delivery device according to any one of claims 1 to 4, wherein, The drug reservoir includes one of the following: a substance attached to a drug via a photosensitive connector; Photogenic cells that secrete drugs in response to changes in intracellular physiological functions induced by light; Photothermal mechanical substances that release drugs by generating heat or expanding through light; And photovoltaic substances that secrete drugs in response to changes in magnetic properties caused by light.

11. The drug delivery device according to any one of claims 1 to 4, wherein, The drug reservoir is housed in a selective membrane configured to block immune response substances generated in response to insertion of the drug delivery device into the body, allow the drug to pass selectively, and allow substances for maintaining the drug reservoir to pass selectively.

12. The drug delivery device according to any one of claims 1 to 4, wherein, The controller is also configured to send one or more pieces of information to an electronic device external to the drug delivery device, including the degree to which the drug reservoir responds to light, the amount of drug released, and whether the drug reservoir needs to be replaced.

13. The drug delivery device according to any one of claims 1 to 4, further comprising: Electrochemical sensors are configured to sense target molecules. The controller is configured to control the amount of drug released by adjusting one or more of the amount of light emitted from the light emitter and the exposure time based on the results obtained by sensing the target molecule with an electrochemical sensor.

14. The drug delivery device according to claim 13, wherein, The controller is also configured to determine the metabolic state in vivo based on the concentration of the sensed target molecule, and to determine whether to apply light stimulation to the drug reservoir based on the determined metabolic state.

15. The drug delivery device according to claim 13, wherein, The electrochemical sensor is configured to sense blood glucose levels in the body, and The controller is also configured to: in response to a sensed blood glucose level exceeding a threshold level, control the light emitter to apply light stimulation that promotes the secretion of insulin from the drug reservoir.

16. The drug delivery device according to any one of claims 1 to 4, wherein, The controller is also configured to control the light emitted from the light emitter based on one or more of signals received from electronic devices outside the drug delivery device and pre-stored information.

17. The drug delivery device according to any one of claims 1 to 4, wherein, The drug reservoir includes a replacement inlet, through which additional drug can be injected from outside the drug delivery device.

18. The drug delivery device according to any one of claims 1 to 4, further comprising: A heat sink passage is configured to discharge heat generated by the light emitter to the outside of the drug delivery device, and the heat sink passage is in contact with the light emitter.

19. A non-transitory computer-readable storage medium storing instructions, wherein, When the instruction is executed by the processor, it causes the processor to: A light emitter is controlled to emit light into a drug reservoir, which is configured to respond to the light and release the drug; and The degree to which the drug reservoir responds to light is monitored by the amount of light passing through it and sensed by a photoelectric sensor. The light emitter is located inside the body. The light emitter comprises multiple light sources arranged in a two-dimensional pattern. A photoelectric sensor is positioned below the light emitter, and a drug reservoir is positioned between the light emitter and the photoelectric sensor. The light emitter, drug reservoir, and photoelectric sensor are arranged in a straight line, such that light emitted from the light emitter passes through the drug reservoir to reach the photoelectric sensor. The process of monitoring the degree to which a drug reservoir responds to light based on the amount of light passing through the drug reservoir and sensed by a photoelectric sensor includes: determining the absorbance of the drug reservoir based on the difference between the amount of light emitted from the light emitter and the amount of light sensed by the photoelectric sensor, and determining the degree to which the drug reservoir responds to light based on the absorbance.

20. A drug delivery device, comprising: A light emitter emits light based on control signals; A drug reservoir, located in the body, is configured to release drugs based on emitted light; A photoelectric sensor is configured to sense light passing through the drug reservoir; and The controller is configured to monitor the drug reservoir based on the amount of light sensed by a photoelectric sensor. The light emitter comprises multiple light sources arranged in a two-dimensional pattern. A photoelectric sensor is positioned below the light emitter, and a drug reservoir is positioned between the light emitter and the photoelectric sensor. The light emitter, drug reservoir, and photoelectric sensor are arranged in a straight line, such that light emitted from the light emitter passes through the drug reservoir to reach the photoelectric sensor. The controller is further configured to determine the absorbance of the drug reservoir based on the difference between the amount of light emitted from the light emitter and the amount of light sensed by the photoelectric sensor, and to determine the degree to which the drug reservoir responds to light based on the absorbance.

21. The drug delivery device according to claim 20, wherein, The controller is also configured to control one or more of the amount, wavelength, and exposure time of light emitted from the light emitter to regulate the amount of drug released from the drug reservoir.

22. The drug delivery device according to claim 20, wherein, A protective biocompatible layer is placed between the light emitter and the drug reservoir.

23. The drug delivery device according to claim 20, wherein, After the drug reservoir is placed in the body, changes in the reactivity of the drug reservoir are calibrated.

24. The drug delivery device according to claim 20, wherein, Two or more drugs are placed in a drug reservoir, and the drug reservoir is also configured to selectively release one of the two or more drugs in response to the wavelength of the emitted light.

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