WO2023132475A1 - 누액을 감지하는 약액 주입 장치 - Google Patents
누액을 감지하는 약액 주입 장치 Download PDFInfo
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- WO2023132475A1 WO2023132475A1 PCT/KR2022/018702 KR2022018702W WO2023132475A1 WO 2023132475 A1 WO2023132475 A1 WO 2023132475A1 KR 2022018702 W KR2022018702 W KR 2022018702W WO 2023132475 A1 WO2023132475 A1 WO 2023132475A1
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- WIPO (PCT)
- Prior art keywords
- leak
- leak detection
- processor
- injection device
- signal
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
- A61M5/5086—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
- A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/15—Detection of leaks
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/18—General characteristics of the apparatus with alarm
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3546—Range
- A61M2205/3561—Range local, e.g. within room or hospital
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
Definitions
- One embodiment of the present invention relates to a chemical solution injection device that detects leakage of a chemical solution or an inflow of a liquid from the outside.
- a drug solution injection device such as an insulin injection device is used to inject a drug solution into a patient's body.
- a liquid injection device is also used by professional medical personnel such as doctors and nurses, but in most cases, it is used by ordinary people such as patients themselves or their guardians.
- a drug injection device in the form of a patch attached to the human body for a certain period of time is being developed, and this drug injection device can be used while being attached to the body such as the abdomen or waist of a patient for a certain period of time.
- the drug solution inside the drug injection device may leak due to a patient's excessive movement, shock, or an unexpected situation.
- external liquid may leak into the inside of the liquid injection device.
- the drug injection device In order to increase the effect through the injection of the chemical solution, the drug injection device must be controlled to accurately inject the drug solution in a predetermined amount into the patient's body at a predetermined time. However, if the patient or the user does not detect the leakage of the chemical solution in advance and the response is delayed, a problem may occur in terms of controlling the amount of the chemical solution. In addition, there is a problem in that the drug injection device is turned off undesirably by the patient or is broken because the leaked drug solution or external liquid invades the circuit board in the drug solution injection device and causes problems.
- One embodiment of the present invention provides a chemical solution injection device that detects leakage of a chemical solution or an inflow of an external liquid and informs the user of this.
- the technical problem to be achieved by the present embodiment is not limited to the technical problems described above, and other technical problems can be inferred from the following embodiments.
- the leak detection device in a liquid injection device attached to a user's body and injecting a liquid liquid, includes one or more tear detection pads mounted on a control module and generating a leak signal by detecting liquid. unit; and a processor mounted in the control module, electrically connected to the leak detection unit, receiving the leak signal, determining whether or not to leak, and notifying the user of information related to the leak when leakage occurs. Initiate.
- an alarm unit that is electrically connected to the processor and generates an alarm of sound, light, or vibration to notify the user of information related to the leakage; or a remote device communicating with the processor and notifying the user of information related to the tear; can include more.
- the information related to the tear includes at least one of whether or not the tear has occurred, the location of the tear, and the type of the tear.
- the leak detection pad includes a first pattern electrically connected to a power source and a second pattern electrically connected to the processor with a predetermined gap therebetween,
- the detection unit includes the one or more leak detection pads connected in parallel; and a voltage divider interposed between the one or more leak detection pads connected in parallel and the processor.
- the leak detection unit includes one or more components including a first pattern electrically connected to a power source and a second pattern electrically connected to the processor with a predetermined gap therebetween. leak detection pad; and one or more voltage dividers interposed between each of the one or more second patterns of the one or more leak detection pads and the processor, wherein the one or more leak detection pads are mounted on the control module at different locations, and the leak detection A unit generates each leak signal from the one or more leak detection pads and inputs it to the processor.
- the leakage signal is a voltage value
- the processor determines the type of leakage through the voltage value and informs the user of the leakage related information.
- the leak detection unit includes a comparator for receiving a reference signal through a first input unit, receiving a modified signal through a second input unit, and outputting the leak signal.
- the deformation signal is input to the second input unit.
- the leak signal has a waveform
- the processor determines the type of leak through at least one of a duty, a pulse width, and a delay of the waveform, and uses information related to the leak as information related to the leak. inform
- the drug injection device is mounted on the first accommodating part formed in the control module and includes a needle assembly including a needle; and a reservoir unit mounted on a second accommodating part formed in the control module to receive the chemical solution, and being connected to one end of the needle to deliver the received chemical solution to the user.
- the one or more leak detection pads are located around the reservoir unit and the needle assembly among the control modules.
- the leakage when leakage occurs in the liquid injection device, the leakage is detected and the user can recognize it, thereby preventing damage to the circuit board or forcible shutdown of the system due to leakage in advance and improving the reliability of the device. There is an effect that can be increased.
- FIG. 1 shows a chemical solution injection system according to an embodiment of the present invention.
- FIG. 2 is an exploded perspective view showing an internal arrangement of the chemical solution injection device of FIG. 1;
- FIG. 3 is a bottom perspective view of the chemical solution injection device of FIG. 2;
- FIG. 4 is a view showing a state in which the attaching portion is removed in FIG. 3 .
- FIG. 5 is a view showing the lower surface of the control module in a state in which the lower cover is removed in FIG. 4 .
- FIG. 6 is a plan view showing the upper surface of the control module and a partially enlarged view showing the inside of the reservoir unit in a state in which parts of FIG. 2 are removed.
- FIG. 7 is a block diagram functionally illustrating the configuration of a control module according to an embodiment of the present invention.
- FIG. 8 illustrates a leak detection unit according to an embodiment of the present invention.
- FIG 9 illustrates a leak detection unit according to another embodiment of the present invention.
- 15 is a flowchart of a tear management method of a chemical solution injection system.
- FIG. 16 illustrates a leak detection unit according to another embodiment of the present invention.
- 17 and 18 show signals related to the leak detection unit of FIG. 16 .
- the leak detection device in a liquid injection device attached to a user's body and injecting a liquid liquid, includes one or more tear detection pads mounted on a control module and generating a leak signal by detecting liquid. unit; and a processor mounted in the control module, electrically connected to the leak detection unit, receiving the leak signal, determining whether or not to leak, and notifying the user of information related to the leak when leakage occurs. Initiate.
- leaking liquid used throughout this specification means not only the leaking of a liquid in a specific container, or the leaked liquid, but also the flowing in of a liquid from the outside into a specific space, or the liquid that has entered. can do.
- the expression "leak detection” used throughout this specification may be a concept encompassing the process of sensing, detecting, or later analyzing both the leaked liquid and the inflow liquid. there is.
- FIG. 1 shows a chemical solution injection system (S) according to an embodiment of the present invention.
- the drug injection system S includes a drug injection device 1 and a remote device 2 .
- the drug solution injection device 1 may be attached to a drug injection object and inject the drug solution stored therein in a set amount to a user.
- the drug solution injection device 1 may be mounted on a user's body.
- the drug solution injection device 1 may be mounted on an animal to inject the drug solution.
- the drug solution injection device 1 may be used for various purposes depending on the type of drug solution to be injected.
- the drug solution may include an insulin-based drug solution for diabetics, other pancreas drug solutions, and other various types of drug solutions for the heart.
- the drug solution injection device 1 may be connected to the remote device 2 connected by wire or wirelessly.
- the user can use the drug injection device 1 by manipulating the remote device 2 and can monitor the use state of the drug injection device 1 .
- the user can monitor the amount of drug injected from the drug injection device 1, the number of injections of the drug, the amount of drug stored in the reservoir, the user's bio information, etc. through the remote device 2.
- the user can drive the chemical solution injection device 1 .
- the user can monitor whether leakage of the chemical solution or intrusion of an external liquid occurs from the chemical solution injection device 1 through the remote device 2, and based on this, the chemical solution injection device 1 can be efficiently managed. there is.
- the remote device 2 refers to a communication terminal capable of using an application in a wired/wireless communication environment.
- the remote device 2 may be a user's portable terminal.
- the remote device 2 is a computer (eg desktop, laptop, tablet, etc.), a media computing platform (eg cable, satellite set-top box, digital video recorder), a handheld computing device (eg For example, PDAs, e-mail clients, etc.), any form of cell phone, any form of wearable device that can be attached to or attached to the user's body, or any form of other type of computing or communication platform.
- the present invention is not limited thereto.
- the drug injection device 1 and the remote device 2 may communicate through a communication network.
- the communication network refers to a communication network that provides an access path so that the remote device 2 can transmit and receive data after accessing the service server (not shown).
- Communication networks include, for example, wired networks such as LANs (Local Area Networks), WANs (Wide Area Networks), MANs (Metropolitan Area Networks), and ISDNs (Integrated Service Digital Networks), wireless LANs, wireless networks such as CDMA, Bluetooth, and satellite communication.
- wired networks such as LANs (Local Area Networks), WANs (Wide Area Networks), MANs (Metropolitan Area Networks), and ISDNs (Integrated Service Digital Networks)
- wireless LANs wireless networks
- wireless networks such as CDMA, Bluetooth, and satellite communication.
- CDMA Code Division Multiple Access
- the remote device 2 is shown as a single device, but the present invention is not necessarily limited thereto, and may include a plurality of devices capable of communicating with the liquid injection device 1.
- FIG. 2 is an exploded perspective view showing an internal arrangement of the chemical solution injection device 1 of FIG. 1 .
- 3 is a bottom perspective view of the chemical solution injection device 1 .
- FIG. 4 is a view showing a state in which the attaching portion 12 in FIG. 3 is removed.
- FIG. 5 is a view showing the lower surface of the control module 700 with the lower cover 17 removed in FIG. 4 .
- 6 is a plan view showing the upper surface of the control module 700 and a partial enlarged view showing the inside of the reservoir unit 200.
- FIGS. 2 to 6 it will be described with reference to FIGS. 2 to 6 .
- the drug solution injection device 1 may include an outer housing 11 covering the outside and an attachment portion 12 positioned adjacent to the user's skin.
- the drug injection device 1 includes a plurality of parts disposed in an inner space between the outer housing 11 and the attaching part 12 .
- a separate bonding means may be further interposed between the attachment part 12 and the user's skin, and the drug solution injection device 1 may be fixed to the skin by the bonding means.
- the drug injection device 1 includes a base body 13, a needle assembly 100, a reservoir unit 200, a pump module 300, a driving unit 400, a clutch unit 500, a trigger member 600, It may include a control module 700 , a leak detection unit 800 , a battery 350 , an alarm unit 900 and a needle cover assembly 150 .
- the base body 13 forms a basic frame of the outer housing 11 and is mounted in the inner space of the outer housing 11 .
- the base body 13 may be provided in plurality.
- a first body 13a covering upper portions of internal components and a second body 13b covering lower portions of internal components may be provided.
- the first body 13a and the second body 13b may be assembled to fix internal parts of the drug injection device 1 to a preset position.
- the base body 13 may be formed as one integral frame.
- the needle assembly 100 may be mounted in a receiving portion implemented in the base body 13 and the control module 700.
- the needle assembly 100 may include a needle N, and one end of the needle N.
- the silver reservoir unit 200 is connected to deliver the drug solution, and the other end is inserted into the user so that the drug solution can be injected into the user along the needle N.
- the user may simply rotate the needle assembly 100 to insert the needle N into the subject and start injecting the drug solution.
- the reservoir unit 200 is mounted on the receiving portion implemented in the base body 13 and the control module 700 and is connected to the needle assembly 100.
- the reservoir unit 200 includes a reservoir 210 and a plunger 230 disposed inside the reservoir and linearly moved by being driven by the pump module 300 and the driving unit 400 .
- the chemical solution is stored in the internal space of the reservoir 210, and the chemical solution can be transferred to the needle N in a fixed amount according to the movement of the plunger 230.
- the pump module 300 may generate driving force and transmit the driving force to the driving unit 400 .
- the pump module 300 may be any type of device having a power to suck in the chemical solution and to discharge the chemical solution by electricity.
- all types of pumps such as mechanical displacement type micropumps and electromagnetic motion type micropumps can be used.
- the driving unit 400 is installed between the pump module 300 and the reservoir unit 200, and moves the plunger 230 disposed inside the reservoir 210 in advance with the driving force generated by the pump module 300.
- the chemical solution may be discharged through the needle N.
- the pump module 300 and the driving unit 400 are driven and engaged with each other by the clutch unit 500 .
- the pump module 300 rotates the drive wheel 420 of the drive unit 400 and is connected to the plunger 230 by the rotation of the drive wheel 420.
- the plunger 230 may move by linearly moving the rod 410 .
- the trigger member 600 may generate a mechanical signal for injecting the drug solution of the drug solution injection device 10 .
- the trigger member 600 is rotatably disposed on one side of the base body 13, the trigger member 600 rotates to start driving the pump module 300, and at the same time the clutch unit 500 drives the drive unit 400. ) can be driven.
- the knob (knob) of the needle assembly 100 presses the end of the trigger member 600, the rotation of the trigger member 600 can be initiated.
- the clutch unit 500 is activated, and the plunger 230 moves forward by coupling or connecting the rod 410 of the driving unit 400 and the driving wheel 420 by the clutch unit.
- the battery 350 may supply electricity to the liquid injection device 1 to activate each part.
- the drawing shows a pair of batteries 350, it is not limited thereto, and may be variously set according to the capacity, use range, use time, etc. of the chemical solution injection device 1.
- the control module 700 may be disposed below the second base body 13b and covered by the lower cover 17 .
- the control module 700 is a circuit board on which at least one processor (750 in FIG. 7) is mounted.
- the control module 700 may have a space capable of accommodating the needle assembly 100, the reservoir unit 200, the pump module 300, and the battery 350.
- the control module 700 is a movement path of electrical signals for electrically connecting the pump module 300, the battery 350, the leak detection unit 800, the alarm unit 900, etc., and the processor (750 in FIG. 7) (not shown). city), for example, wiring.
- the processor (750 in FIG. 7 ) may control the overall operation of the chemical solution injection device 1 . A detailed description of the processor (750 in FIG. 7) will be described later.
- the leak detection unit 800 may be mounted on the control module 700 .
- the leak detection unit 800 may be connected to a wire on the control module 700 to receive a voltage and transmit a signal to the processor (750 in FIG. 7 ).
- the leakage detection unit 800 may be located anywhere on the control module 700, but may be particularly located around a place where the liquid medicine is stored or a path along which the liquid medicine moves.
- the leak detection unit 800 is concerned with leaks among the surfaces facing the outer housing 11, which is the “upper surface” of the control module 700, such as the periphery of the reservoir unit 200 or It may be disposed around the needle assembly 100 .
- the leak detection unit 800 is a part of the control module 700 facing the lower cover 17, which is the “lower surface” of the control module 700, where leakage is a concern, for example, the periphery of the reservoir unit 200 or It may be disposed around the needle assembly 100 .
- the leak detection unit 800 may be disposed on a part close to the base body 13, which is the “side” of the control module.
- the leak detection unit 800 includes a part adjacent to the base body 13, a part adjacent to the battery 350 or the driving unit 400, and a control module 700 corresponding to the lower cover 17. ), it can be located anywhere as long as it is a part where liquid can flow from the outside, such as the upper surface, lower surface, side and both sides. A detailed description of the leak detection unit 800 will be described later.
- the battery 350 is disposed adjacent to the driving unit 400 and may supply electricity to the driving unit 400 .
- the battery 350 is connected to the control module 700 and may supply voltage to the leak detection unit 800 through the control module 700 .
- the alarm unit 900 is disposed inside or outside the drug injection device 1, and can inform a user of normal operation or malfunction of the drug injection device 1. For example, the alarm unit 900 may inform the user of leakage of liquid through an alarm. The alarm unit 900 may deliver an alarm to a user by generating a warning sound, light, or vibration.
- the alarm unit 900 is disposed under the outer housing 11 and is electrically connected to the control module 700 which is a circuit board.
- a movement path (not shown) of an electrical signal for transmitting an alarm signal to the alarm unit 900 may be formed on the control module 700 .
- FIG. 7 is a block diagram functionally illustrating the configuration of a processor 750 according to an embodiment of the present invention.
- the processor 750 may be mounted on the control module 700 to control overall operation of the chemical solution injection device 1 .
- the processor 750 is electrically connected to the pump module 300, the battery 350, the leak detection unit 800, the alarm unit 900, etc., controls their overall operation, and communicates with the remote device 2. .
- the processor 750 may be implemented as a Micro Controller Unit (MCU). However, it is not limited thereto, and a digital signal processor (DSP), microprocessor, TCON (Time controller), central processing unit (CPU), and MPU (micro processing unit) process digital signals. unit), a controller, an application processor (AP), a communication processor (CP), or an ARM processor.
- the processor may be implemented as a system on chip (SoC) having a processing algorithm, a large scale integration (LSI), or a field programmable gate array (FPGA).
- SoC system on chip
- the processor 750 is electrically connected to the leak detection unit 800, receives a signal, communicates with the remote device 2, and manages leak issues.
- the leakage issue includes an issue in which an external liquid flows into the chemical solution injection device 1 in addition to an issue in which the chemical solution stored in the chemical solution injection device 1 leaks.
- contents of the processor 750 related to the leakage issue will be described in detail.
- the processor 750 may include a leakage management unit 710 , a communication unit 720 , and a memory 730 .
- these components are examples, and the control module 700 may further include additional components or omit some of the components described above as needed.
- the leak management unit 710 analyzes the electrical signal or data input from the leak detection unit 800 to determine whether or not the leak occurs, the location of the leak, and the type of leaked or introduced liquid. In addition, when an issue related to leakage occurs, the leakage management unit 710 may notify the user of the leakage issue by controlling the alarm unit 900 or generating a message to be sent to the remote device 2 .
- the communication unit 720 exchanges and communicates data with the remote device 2 through the aforementioned communication network, transmits a message generated by the leakage management unit 710 to the remote device 2, and receives data from the remote device 2. do.
- the memory 730 has a function of temporarily storing data received from the leak detection unit 800, temporarily storing data processed by the leak management unit 710, or temporarily storing data from the remote device 2. do. In addition, the memory 730 stores information and data necessary for determining the location of leaked liquid and the type of leaked or introduced liquid.
- processor 750 is shown as being included in the control module 700 of the drug injection device 1 in FIG. 7, the present invention is not limited thereto and according to an optional embodiment, the processor 750 may be included in the remote device 2 It may be implemented as a configuration included in.
- FIG 8 shows a leak detection unit 800 according to an embodiment of the present invention.
- 9 shows a leak detection unit 800 according to another embodiment of the present invention.
- the leak detection unit 800 includes at least one or more leak detection pads 810 .
- the leak detection pad 810 is installed on the control module 700, which is a circuit board (see FIGS. 5 and 6).
- the leak detection pad 810 includes a first pattern 811 electrically connected to a power source through the control module 700 and a second pattern 812 electrically connected to the processor (750 in FIG. 7 ) through the control module 700. , and a gap 813 having a predetermined size is formed between one side boundary of the first pattern 811 and one side boundary of the second pattern 812 .
- the first pattern 811 of the leak detection pad 810 is connected to a battery through an electrical movement path on the circuit board to receive a constant reference voltage (V DD ), and the second pattern 812 is connected to the battery through an electrical movement path on the circuit board. It is connected to the input pin of the processor (750 in FIG. 7) through an electrical movement path and can input a predetermined signal to the leak management unit (710 in FIG. 7).
- the signal may be a digital signal or an analog signal.
- the leak detection unit 800 may further include a voltage divider 820 .
- the voltage divider 820 may be, for example, a resistor, and is electrically connected between one end of the second pattern 812 electrically connected to the processor (750 in FIG. 7) and an input pin of the processor (750 in FIG. 7). Thus, stable driving of the leak detection unit 800 can be guaranteed.
- the voltage divider 820 is selected to have a resistance greater than the resistance of the leaked or introduced liquid. This is because when a resistance smaller than the resistance of the leak is selected, the current consumption increases, making it difficult to stably drive the leak detection unit 800 .
- the resistance value of the voltage divider can be selected to be about 800 to 1200 kilohm (kilohm), preferably 1M ⁇ (megaohm).
- FIG. 8 illustrates an embodiment in which a plurality of leak detection pads 810 are electrically connected to one input pin to transmit a comprehensive signal to the processor (750 in FIG. 7 ).
- the processor (750 in FIG. 7 ) may only determine whether leakage occurs in the liquid injection device 1 .
- a plurality of leak detection pads 810 may be electrically connected to a plurality of input pins, respectively, to transmit respective signals (sensing_1 to sensing_N) to the processor (750 in FIG. 7 ).
- the processor (750 in FIG. 7 ) may determine whether or not leakage has occurred as well as “at what position” within the liquid injection device 1 the leakage has occurred.
- the leak detection pad 810 may be implemented in various forms.
- the leak detection pad 810 may be implemented in a circular shape, a polygonal shape, a linear shape, a polygonal shape, a curved shape, and the like. Any structure with a constant gap 813 between 812 is possible.
- the boundary of the first pattern 811 and the boundary of the adjacent second pattern 812 may be designed to have a surface area adjacent to each other as wide as possible.
- the gap 813 between the first pattern 811 and the second pattern 812 may be designed to have a curved or zigzag shape to increase the leak detection success rate.
- FIG. 14 schematically shows the location of the leak detection pad 810 on the control module 700 .
- the leak detection pad 810 may be applied to any part such as the upper surface (a), lower surface (b), side surface (c), or both surfaces (d) of the control module 700 as long as there is a risk of leakage. placed without restrictions.
- the leak detecting pad 810 may be located on a circuit board near a reservoir unit (RU seat) in which the liquid medicine is stored or near a needle assembly (NU seat) through which the liquid medicine is moved.
- RU seat reservoir unit
- NU seat needle assembly
- 15 is a flow chart of a tear management method of the chemical solution injection system (S) or the chemical solution injection device (1).
- a leakage issue occurs in step 101 .
- the drug injection device (1 in FIG. 1 ) is attached to the user with the drug solution stored therein, and can inject the drug solution in a set amount to the user.
- the drug solution is stored in the internal space of the reservoir unit (200 in FIG. 2), and the drug solution is injected into the user through a needle (N in FIG. 2).
- the chemical solution may leak due to unexpected circumstances during the process of storing the chemical solution or attaching and using the chemical solution injection device 1 .
- liquid may flow into the chemical solution injection device 1 from the outside.
- the control module (700 in FIG. 5) which is a circuit board, is damaged due to leaking or inflowing liquid, or the chemical solution injection device 1 is turned off. It is necessary to detect the leak before it becomes available and notify the user.
- step 102 the leak detection unit (800 in FIGS. 5 and 8) senses the leaked fluid.
- the leak detection pad 810 included in the leak detection unit 800 includes a first pattern 811 and a second pattern 812 made of a conductive material.
- a predetermined voltage (V DD ) is applied to the first pattern 811 and the second pattern 812 may be connected to the ground or low voltage through the voltage divider 820 .
- V DD voltage
- the first pattern 811 and the second pattern 812 do not contact each other and maintain a constant gap 813, so that the leakage management unit electrically connected to the second pattern 812 (FIG. 7) In 710), it is confirmed that there is no input of the voltage value of OV or the voltage value.
- step 103 the processor (750 in FIG. 7) receives a leak related signal from the leak detecting unit 800.
- the processor (750 in FIG. 7 ) receives a leak signal such as a changed voltage value from the leak detecting unit 800 when a leak issue occurs.
- the leak management unit ( 710 in FIG. 7 ) may receive an on/off signal or a high/low signal as the leak signal.
- step 104 the processor (750 in FIG. 7) may determine whether liquid is leaked.
- the leak management unit ( 710 in FIG. 7 ) of the processor ( 750 in FIG. 7 ) may analyze the leak signal input from the leak detecting unit 800 to determine whether or not fluid is leaked. For example, the leak managing unit (710 in FIG. 7 ) may determine that a leak issue has occurred when a change in a voltage value input from the leak detecting unit 800 reaches a set range. As an optional embodiment, when the tear management unit ( 710 in FIG. 7 ) receives an on/off signal or a high/low signal as a leak signal, it may be determined that a leak issue has occurred through a change in the signal.
- the processor may determine the leak location.
- each leak detection pad 810 may respectively input an individual leak signal to the processor (750 in FIG. 7 ). Accordingly, the leak management unit (710 in FIG. 7 ) of the processor (750 in FIG. 7 ) may determine the location of the leak by checking from which leak detection pad the leak signal is input. The information connecting the leak signal and the leak location may be stored in the memory (730 in FIG. 7) of the processor (750 in FIG. 7), and the leak management unit (710 in FIG. 7) stores the information in the memory (730 in FIG. 7). The location of leakage may be determined using the stored information.
- the processor may determine the type of leakage.
- a voltage value may be input as a leak signal to the processor (750 in FIG. 7 ).
- the leak management unit ( 710 in FIG. 7 ) of the processor ( 750 in FIG. 7 ) may determine which liquid has caused the leak issue when a change in the voltage value input from the leak detection unit 800 reaches a specific range.
- the resistance of insulin is about 300 k ⁇ (kilohm) to 500 k ⁇ (kilohm). If the reference voltage (V DD ) input to one end of the leak detection unit 800 is 3V (volt), when insulin is detected on the leak detection pad 810, about 2V to 2.3V as a leak signal is supplied to the leak management unit (Fig.
- the drug injection device 1 can determine that insulin has leaked or flowed in.
- water has a resistance of about 2 k ⁇ (kilohm) to 200 k ⁇ (kilohm).
- V DD reference voltage
- the reference voltage (V DD ) input to one end of the leak detection unit is 3V (volt)
- the reference voltage (V DD ) input to one end of the leak detection unit is 3V (volt)
- the chemical solution injection device 1 can determine that water has leaked or flowed in.
- Salt water for example, has a resistivity of about 0.2 ohms. If the reference voltage (V DD ) input to one end of the leak detection unit 800 is 3V (volt), when salt water is detected on the leak detection pad 810, about 3V as a leak signal is sent to the leak management unit (710 in FIG. 7 ). ) is entered. Therefore, if 3V is input as the leakage signal, the chemical solution injection device 1 may determine that saline water has leaked or flowed in.
- the above-mentioned leak signal and information connecting the leak type may be stored in the memory (730 of FIG. 7) of the processor (750 of FIG. 7). Therefore, the leak management unit (710 in FIG. 7 ) may determine which liquid has leaked or flowed through a leak signal, specifically, a voltage value, using information stored in a memory (730 in FIG. 7 ).
- the leakage management unit (710 in FIG. 7 ) notifies the user of the leakage issue through various methods.
- the processor may control the alarm unit 900 electrically connected to the control module 700 to generate a leak alarm.
- the alarm unit 900 may generate any one or more of light or vibration to inform the user of the leakage issue.
- the alarm unit 900 generates sound, light, or vibration at predetermined intervals, generates sounds of a specific height, intensity, or style, emits light of a specific color or interval, or emits light of a specific intensity, interval, or time.
- a light may be issued to inform the user of the leakage issue.
- the tear management unit (710 in FIG. 7) in step 109, the tear management unit (710 in FIG. 7) generates an alarm message notifying that an issue related to the tear has occurred and controls the communication unit (720 in FIG. 7) to transmit the message to the remote device (2).
- the alarm message may also include information on the location of the leak determined in step S105 and the type of leak determined in step S106, in addition to whether or not leakage occurs.
- step 110 the remote device 2 connected to the drug injection device 1 through a communication network receives the message and informs the user that leakage has occurred in the drug injection device 1 in various ways.
- the remote device 2 displays an alarm message on the display screen so that the user can check the leakage issue. Through the message, the user can check not only the occurrence of the leak, but also the location and type of the leak. In addition, the remote device 2 may inform the user that a message related to the leakage issue has been received through sound, vibration, light, or the like.
- Steps 107 and 108 and 109 and 110 of the present invention may be performed simultaneously, or only steps 107 and 108 or only steps 109 and 110 may be performed according to a user's selection or setting method.
- the leakage when leakage occurs in the liquid injection device 1, the leakage is detected and the user can recognize it, thereby preventing damage to the circuit board and forcible shutdown of the system due to the leakage in advance and improving the quality of the device. It has the effect of increasing reliability.
- the liquid injection device 1 when leakage occurs in the liquid injection device 1, it is possible to determine not only whether the leakage occurred, but also the location where the liquid leaked or flowed in or the type of leaked or inflowed liquid, so that the user can quickly and effectively solve the leakage issue. It has the advantage of being able to respond accurately.
- 16 shows a leak detection unit 800 according to another embodiment of the present invention.
- 17 and 18 show signals related to the leak detection unit 800 of FIG. 16 .
- the leak detection unit 800 further includes a comparator 840 in addition to the leak detection pad 810 .
- the comparator 840 includes a first input unit (1) and a second input unit (2), and the first input unit (1) and the second input unit (2) are electrically connected to the waveform generator 850 for receiving a constant waveform. Connected.
- One end of the leak detection pad 810 for example, the first pattern 811, may be electrically connected between the waveform generator 850 and the second input unit 2.
- the other end of the leak detection pad 810 for example, the second pattern 812, may be electrically connected to the ground or low voltage.
- the first pattern 811 and the second pattern 812 made of a conductive material do not contact each other, and a predetermined gap exists between the two patterns.
- a reference signal is input to the first input unit (1) of the comparator 840, and the same reference signal is input to the second input unit (2).
- the signal generated by the waveform generator 850 may be a PWM (pulse width modulation) signal as shown in FIGS. 17 and 18, but is not limited thereto, and may be a square wave or a sine wave.
- the output value of the comparator 840 may have a first value or a second value, and is input to a processor (750 in FIG. 7).
- the comparator When the same signal is input to the first input unit (1) and the second input unit (2) of the comparator 840, the comparator outputs a first value (eg, a low value), and the first input unit (1) of the comparator
- the comparator When a different signal is input to the second input unit (2), the comparator may output a second value (eg, a high value).
- the leakage management unit (710 in FIG. 7 ) of the processor (750 in FIG. 7 ) may determine that the leakage issue has not occurred if the first value is input, and may determine that the leakage issue has occurred if the second value is input. there is.
- a diode 860 for protecting elements from reverse current is provided between the waveform generator 850 and the first input unit 1 and between the waveform generator 850 and one end of the leakage detection pad 810, respectively. can intervene.
- the signal input to the second input unit (2) of the comparator 840 is not affected by the leak detection pad 810.
- the signal (second input unit input signal) input to the second input unit (2) of the comparator 840 has the same duty and pulse width as the reference signal (Ref signal) and no delay. . Therefore, the output value of the comparator 840 outputs a first value, and this output value is input to the processor (750 in FIG. 7 ), and the leak management unit (710 in FIG. 7 ) determines that the leak issue does not occur.
- the signal input to the second input unit (2) is deformed due to the capacitance of 810).
- the signal input to the second input unit 2 (second input unit input signal) has a duty different from that of the reference signal (Ref signal), a pulse width different from that of the reference signal, or a reference signal. It may be a signal in which a delay occurs compared to the signal. Therefore, the output value of the comparator 840 outputs a second value, and this output value is input to the processor (750 in FIG. 7), and the leak management unit (710 in FIG. 7) determines that the leak issue has occurred.
- the tear management unit (710 in FIG. 7 ) may determine the type of tear through the output value of the comparator 840 .
- the second input value (2) input to the comparator 840 has a unique duty and pulse width depending on the type of leaked or introduced liquid.
- a modified signal having a width and/or a delay may be generated. Therefore, when a liquid leakage issue occurs, the comparator 840 compares the reference signal input to the first input unit 1 and the modified signal input to the second input unit 2, so that the output value of the comparator is set to a constant duty, pulse width and/or Alternatively, it can be output as a signal with a delay.
- the output value of the comparator 840 is input to the processor (750 in FIG.
- Information linking the aforementioned output value and the type of leakage may be stored in a memory ( 730 in FIG. 7 ) of the processor ( 750 in FIG. 7 ). Therefore, the leak management unit 710 may determine which liquid has leaked or flowed in by analyzing the output value of the leak detection unit 800 using the information stored in the memory 730 .
- Embodiments according to the present invention described above may be implemented in the form of a computer program that can be executed on a computer through various components, and such a computer program may be recorded on a computer-readable medium.
- the medium is a magnetic medium such as a hard disk, a floppy disk and a magnetic tape, an optical recording medium such as a CD-ROM and a DVD, a magneto-optical medium such as a floptical disk, and a ROM hardware devices specially configured to store and execute program instructions, such as RAM, flash memory, and the like.
- the computer program may be specially designed and configured for the present invention, or may be known and usable to those skilled in the art of computer software.
- An example of a computer program may include not only machine language code generated by a compiler but also high-level language code that can be executed by a computer using an interpreter or the like.
- One embodiment of the present invention relates to a chemical solution injection device that detects leakage of a chemical solution or an inflow of a liquid from the outside.
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Abstract
Description
Claims (10)
- 사용자의 몸에 부착되어 약액을 주입하는 약액 주입 장치에 있어서,제어 모듈에 장착되며 액체의 감지에 의해 누액 신호를 생성하는 하나 이상의 누액 감지 패드를 포함하는 누액 감지 유닛; 및상기 제어 모듈에 장착되어 상기 누액 감지 유닛과 전기적으로 연결되며 상기 누액 신호를 입력받아 누액 여부를 판단하여, 누액이 발생한 경우 누액과 관련된 정보를 상기 사용자에게 알리는 프로세서;를 포함하는, 약액 주입 장치.
- 제1항에 있어서,상기 프로세서와 전기적으로 연결되며 소리, 빛 또는 진동의 알람을 발생하여 상기 사용자에게 상기 누액과 관련된 정보를 알리는 알람 유닛; 및상기 프로세서와 통신하며 상기 사용자에게 상기 누액과 관련된 정보를 알리는 원격 장치; 더 포함하는, 약액 주입 장치.
- 제1항에 있어서,상기 누액과 관련된 정보는 누액이 발생하였는지 여부, 누액의 발생 위치 및 발생한 누액의 종류 중 하나 이상을 포함하는, 약액 주입 장치.
- 제1항에 있어서,상기 누액 감지 패드는 전원에 전기적으로 연결된 제1패턴, 상기 제1패턴과 일정한 갭을 사이에 두고 상기 프로세서와 전기적으로 연결된 제2패턴을 포함하며,상기 누액 감지 유닛은병렬로 연결된 상기 하나 이상의 누액 감지 패드; 및상기 병렬로 연결된 하나 이상의 누액 감지 패드와 상기 프로세서 사이에 개재된 하나의 전압 디바이더;를 더 포함하는, 약액 주입 장치.
- 제1항에 있어서,상기 누액 감지 유닛은전원에 전기적으로 연결된 제1패턴, 상기 제1패턴과 일정한 갭을 사이에 두고 상기 프로세서와 전기적으로 연결된 제2패턴을 포함하는 상기 하나 이상의 누액 감지 패드; 및상기 하나 이상의 누액 감지 패드의 제2패턴 각각과 상기 프로세서 사이에 개재된 하나 이상의 전압 디바이더;를 포함하며,상기 하나 이상의 누액 감지 패드는 각각 서로 다른 위치의 상기 제어 모듈에 장착되고, 상기 누액 감지 유닛은 상기 하나 이상의 누액 감지 패드로부터 각각의 누액 신호를 생성하여 상기 프로세서로 입력하는, 약액 주입 장치.
- 제4항에 있어서,상기 누액 신호는 전압값이며 상기 프로세서는 상기 전압값을 통해 누액의 종류를 판단하여 상기 누액과 관련된 정보로써 상기 사용자에게 알리는, 약액 주입 장치.
- 제1항에 있어서,상기 누액 감지 유닛은제1입력부로 레퍼런스 신호를 입력받고 제2입력부로 변형 신호를 입력받고 상기 누액 신호를 출력하는 비교기를 포함하고,상기 제2입력부에는 상기 누액 감지 패드가 전기적으로 연결되어 누액이 발생한 경우 상기 변형 신호를 상기 제2입력부에 입력하는, 약액 주입 장치.
- 제7항에 있어서,상기 누액 신호는 파형을 가지며, 상기 프로세서는 상기 파형의 듀티, 펄스폭 및 딜레이 중 적어도 하나를 통해, 누액의 종류를 판단하여 상기 누액과 관련된 정보로써 상기 사용자에게 알리는, 약액 주입 장치.
- 제1항에 있어서,상기 약액 주입 장치는상기 제어 모듈에 형성된 제1수용부에 장착되며 니들을 포함하는 니들 조립체; 및상기 제어 모듈에 형성된 제2수용부에 장착되며 상기 약액을 수용하고, 상기 니들의 일단과 연결되어 수용된 상기 약액을 상기 사용자에게 전달하는 레저버 유닛;을 더 포함하는, 약액 주입 장치.
- 제9항에 있어서,상기 하나 이상의 누액 감지 패드는 상기 제어 모듈 중에서도 상기 레저버 유닛의 주변 및 상기 니들 조립체의 주변에 위치하는, 약액 주입 장치.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US18/725,582 US20260077138A1 (en) | 2022-01-04 | 2022-11-24 | Liquid medicine injection device for sensing leakage |
| EP22919012.9A EP4461331A4 (en) | 2022-01-04 | 2022-11-24 | Liquid medicine injection device for sensing leakage |
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR10-2022-0001046 | 2022-01-04 | ||
| KR20220001046 | 2022-01-04 | ||
| KR1020220048653A KR102776937B1 (ko) | 2022-01-04 | 2022-04-20 | 누액을 감지하는 약액 주입 장치 |
| KR10-2022-0048653 | 2022-04-20 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2023132475A1 true WO2023132475A1 (ko) | 2023-07-13 |
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ID=87073879
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/KR2022/018702 Ceased WO2023132475A1 (ko) | 2022-01-04 | 2022-11-24 | 누액을 감지하는 약액 주입 장치 |
Country Status (3)
| Country | Link |
|---|---|
| US (1) | US20260077138A1 (ko) |
| EP (1) | EP4461331A4 (ko) |
| WO (1) | WO2023132475A1 (ko) |
Citations (5)
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| KR100605000B1 (ko) * | 2003-04-28 | 2006-07-26 | 가부시키가이샤 네모또 쿄린도 | 혈관에 주입되는 약액의 누출을 펄스신호를 이용하여검출하는 누출검출장치 |
| JP4762147B2 (ja) * | 2004-09-14 | 2011-08-31 | 株式会社根本杏林堂 | 漏出検出装置 |
| JP6019115B2 (ja) * | 2012-06-14 | 2016-11-02 | タツタ電線株式会社 | 液体検知センサー |
| US20160317739A1 (en) * | 2015-05-01 | 2016-11-03 | Medtronic Minimed, Inc. | Method and System for Leakage Detection in Portable Medical Devices |
| JP2021171302A (ja) * | 2020-04-24 | 2021-11-01 | 国立大学法人浜松医科大学 | 漏出検出装置 |
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| US6461329B1 (en) * | 2000-03-13 | 2002-10-08 | Medtronic Minimed, Inc. | Infusion site leak detection system and method of using the same |
| WO2011087059A1 (ja) * | 2010-01-15 | 2011-07-21 | 株式会社根本杏林堂 | 漏出検出ユニットおよび漏出検出システム |
| US10384002B2 (en) * | 2015-01-30 | 2019-08-20 | Mackay Memorial Hospital | Sensor patch, system, and method for detecting fluid leakage |
| CN108348675B (zh) * | 2015-11-26 | 2020-12-22 | 深圳市泽智知识产权有限公司 | 用于医疗器械的漏液检测装置 |
-
2022
- 2022-11-24 WO PCT/KR2022/018702 patent/WO2023132475A1/ko not_active Ceased
- 2022-11-24 EP EP22919012.9A patent/EP4461331A4/en not_active Withdrawn
- 2022-11-24 US US18/725,582 patent/US20260077138A1/en active Pending
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| KR100605000B1 (ko) * | 2003-04-28 | 2006-07-26 | 가부시키가이샤 네모또 쿄린도 | 혈관에 주입되는 약액의 누출을 펄스신호를 이용하여검출하는 누출검출장치 |
| JP4762147B2 (ja) * | 2004-09-14 | 2011-08-31 | 株式会社根本杏林堂 | 漏出検出装置 |
| JP6019115B2 (ja) * | 2012-06-14 | 2016-11-02 | タツタ電線株式会社 | 液体検知センサー |
| US20160317739A1 (en) * | 2015-05-01 | 2016-11-03 | Medtronic Minimed, Inc. | Method and System for Leakage Detection in Portable Medical Devices |
| JP2021171302A (ja) * | 2020-04-24 | 2021-11-01 | 国立大学法人浜松医科大学 | 漏出検出装置 |
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Also Published As
| Publication number | Publication date |
|---|---|
| EP4461331A1 (en) | 2024-11-13 |
| EP4461331A4 (en) | 2025-04-23 |
| US20260077138A1 (en) | 2026-03-19 |
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