Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
  • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/08—Solutions
• • 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
  • A61M5/178—Syringes
  • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
  • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
  • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection

Definitions

• the present invention relates to a drug distribution service system, needle-free injection device, and management system that distribute medical kits that allow the delivery of needle-free drug cartridges and the injection of drugs into designated areas of patients by opening the cartridges.
• Patent Document 1 discloses, as an example of an injection kit with a built-in needle, that "the present disclosure provides systems, devices, and methods for injecting drugs, substances, and/or chemicals into a patient to improve their effectiveness when injected. Additional treatment is applied to a patient's tissue area into which a drug (e.g., insulin) is injected, exposing the tissue area to various forms of energy or substances to improve the pharmacokinetic and/or pharmacodynamic profile of the drug.”
• a drug e.g., insulin
• Patent Document 2 describes the injection of exosomes as a drug into a patient's vein or by using a catheter.
• paragraph 0004 of Patent Document 2 discloses, "In one aspect, provided herein is a method for treating renal disease in a subject. In certain embodiments, the method comprises administering to the subject an effective amount of isolated secreted renal cell vesicles, wherein the vesicles are administered by intravenous injection or via catheter delivery.”
• Patent Document 3 discloses an injection device in which a drug and an injection needle are integrated. Specifically, paragraph 0027 of Patent Document 3 discloses: "[0091] Referring to FIG. 3B, the housing 112 is configured to accommodate a fluid reservoir 118 having one volume of a drug among a plurality of volumes of the drug. Prior to assembling the injection device 110, the desired volume of the fluid reservoir 118 is selected. In one embodiment, the desired volume of the fluid reservoir 118 is based on a desired maximum single dose that can be injected into a patient. In one embodiment, the injection device 110 is configured to receive one size container or syringe having fluid reservoirs 118 configured to accommodate multiple (e.g., four) different maximum volumes for injection. In other embodiments, the injection device 110 is configured to receive fluid reservoirs configured to accommodate two, three, or five or more different maximum volumes for injection.”
• drugs can also be administered as inhalants or as drops administered intravenously.
• injections drugs can also be administered as inhalants or as drops administered intravenously.
• the present invention has been made to solve the above problems, and aims to provide a drug distribution service system, needle-free injection device, and management system that can freely create a medical service environment in which medical kits for safely administering subcutaneous injections into the patient's buttocks can be safely distributed at the appropriate temperature without imposing an operational burden on the patient, by simply inserting a needle-free drug cartridge, delivered as a kit for injecting drugs into a loaned holder.
• the drug distribution service system is a drug distribution service system that distributes ampoules filled with a specific drug from an injector separated from a needleless injection device that is integrated with the injector by attaching the ampoules to the injector using a transport unit, and is characterized in that the transport unit has at least a three-layer structure to maintain the temperature of the ampoules filled with the specific drug at or below a specific freezing temperature, and has a cold air passage in one layer that circulates cold air toward the upper or lower layer and has the function of circulating cold air taken in from the other layers.
• the needle-free injection device is a needle-free injection device in which an ampoule filled with a specific drug is attached to an injector, and is characterized in that it includes a transport unit that transports a plurality of packages containing the ampoules, and the ampoules contained in the transport unit are transported to a registered destination in a state in which the ampoules are repackaged in a medical kit at a temperature equal to or lower than a first freezing temperature, the ampoules removed from the medical kit are stored in a storage facility at a second freezing temperature higher than the first freezing temperature, and the package removed from the storage facility is opened in a room temperature atmosphere and thawed to a temperature suitable for subcutaneous injection, and the removed ampoules are attached to the injector.
• the management system is a management system that manages the condition of a patient who has been subcutaneously injected with an ampule filled with a specified drug that is delivered periodically, a needleless injection device in which the ampule is attached to an injector, and a data terminal operated by a caregiver who cares for the patient, through communication with each other via a network, and is characterized in that the management server comprises an acquisition means for acquiring an image of the patient from the data terminal, an image storage means for storing the image of the patient acquired by the acquisition means in association with the consumption amount of the specified drug that is delivered periodically, and an analysis means for analyzing changes in the patient's symptoms based on the image of the patient stored in the image storage means and the consumption amount of the specified drug that is delivered periodically.
• a simple operation of inserting a needleless drug cartridge, delivered as a kit for injecting drugs into a rented holder makes it possible to freely create a medical service environment in which frozen drugs can be safely distributed at the correct temperature for safe subcutaneous injection into the patient's buttocks without imposing any operational burden on the patient.
• FIG. 1 is a block diagram illustrating a configuration of a medicine distribution service system according to an embodiment of the present invention.
• FIG. 2 is a block diagram illustrating the hardware configuration of the data terminal and the management server shown in FIG. 1 .
• 3 is a block diagram illustrating a configuration of a data processing program provided by the management server 4 shown in FIG. 2.
• 1 is a diagram for explaining the configuration of a medicine distribution service system according to an embodiment of the present invention
• 1 is a diagram for explaining the configuration of a medicine distribution service system according to an embodiment of the present invention
• 1 is a diagram for explaining the configuration of a medicine distribution service system according to an embodiment of the present invention
• 1 is a diagram for explaining the configuration of a medicine distribution service system according to an embodiment of the present invention
• 1 is a diagram for explaining the configuration of a medicine distribution service system according to an embodiment of the present invention
• 1 is a diagram for explaining the configuration of a medicine distribution service system according to an embodiment of the present invention
• FIG. 1 is a block diagram illustrating the configuration of a medicine distribution service system according to this embodiment.
• reference numeral 1 denotes a network which handles communications between a data terminal 2 operated by a nurse who looks after a patient, a data terminal 3 operated by a doctor who diagnoses the patient's condition, a data terminal 7 operated by a company that delivers drug kits prescribed by the doctor, and a management server 4 which collects and manages the delivery status of the kits and the patient's condition.
• Reference numeral 5 denotes a management unit, which is equipped with a freezer 5A for storing ampoule kits AK of drugs prescribed by doctors at a temperature of, for example, -80°C.
• a freezer 6A is provided in which the frozen ampoule kit AK is taken out from the vacuum insulated cool box 8 and then frozen and stored at, for example, -20°C.
• the Ampoule Kit AK contains a frozen ampoule that is pre-injected with exosomes that have a specific chemical structure and is a medicine prescribed by a doctor, sealed in a package.
• FIG. 2 is a block diagram for explaining the hardware configuration of the data terminals 2, 3, 7 and the management server 4 shown in FIG. 2, reference numeral 11 denotes a communication unit which performs data communication with a management server 4 via a network 1 in accordance with a predetermined protocol.
• a data terminal 2 operated by a nurse for the patient can communicate with a data terminal 3 operated by a doctor via the network 1.
• the data terminal 3 operated by the doctor can communicate via the network 1 with a data terminal 7 operated by a company that delivers the ampoule kit AK to the patient's home.
• the management server 4 and the data terminals 2, 3, and 7 shown in FIG. 1 are capable of communicating with each other, and by connecting to a web page provided by the management server 4 and registering as a user, it is possible to chat via the drug distribution application screen operated by the management server 4. Also, by connecting to a web page provided by the management server 4 and holding a video conference, a function is provided for distributing a video of the patient's facial expression via a camera (described later) provided in the data terminal 2 operated by the nurse who is caring for the patient.
• a camera described later
• the communication unit 21 connects to the data terminals 2, 3, and 7 via the network 1 and performs communication processing.
• the CPU 22 starts up the operating system stored in the ROM 24, and reads various service programs from the external memory 29 onto the RAM 23 and executes them, thereby providing various data communication services to the data terminals 2, 3, and 7.
• a patient database that manages patients who are prescribed a specific medicine, the doctor who prescribed the specific medicine, and the delivery company who delivers the medicine prescribed by the doctor as one group, and also acquires and stores information on the patient's physical condition that changes when the prescribed specific medicine is injected subcutaneously into the patient, as well as video, still images, and audio showing changes in facial expression, from the data terminal 2.
• an evaluation AI unit 28A is constructed in the patient database 28, which learns and accumulates sample pixel information for evaluating changes in a specified medical condition, and the management server 4 uses the evaluation AI unit 28 to provide the information to the data terminal 3 operated by the doctor as needed to determine the progress of the medical condition and the state of improvement of the medical condition.
• 23-1 is a user registration unit that performs the process of registering user accounts set by each operator (nurse, contractor) who operates the data terminals 2 and 7 in the external memory 29.
• 23-2 is a doctor registration unit that performs data processing to register a user account set up by a doctor using this service system by operating the data terminal 3 in the external memory 29.
• 23-3 is the data acquisition unit, which receives videos and still images showing the patient's symptoms and facial expressions written on the rounds form periodically from the data terminal 2, and also performs data processing to register the electronic medical record information received from the data terminal 3, the electronic prescription issued to the patient, and the medical treatment schedule in the patient database 28.
• 23-4 is a drug delivery management unit that processes data, such as drug delivery schedules ordered from vendors operating data terminals 7, and delivery notices returned from vendors, and stores and manages them in external memory 29.
• the evaluation unit 23-5 is the evaluation unit, which analyzes the patient information received from the data terminal 2 based on the evaluation AI unit 28A stored in the patient database 28, performs AI judgment as to whether the symptoms have improved or progressed since the initial diagnosis, and performs data processing to set the evaluation information in a specified diagnostic progress form that notifies the doctor.
• the specified diagnostic progress form is configured so that the doctor can view the latest symptoms by operating the data terminal 3 and entering the patient ID and password.
• 23-6 is a data update unit that performs data processing to update the patient information stored in the patient database 28 to the latest information based on the patient information received from the data terminal 2.
• a needleless injection device consisting of an ampule AP attached to an injector, and a data terminal operated by a caregiver who cares for the patient, communicate through a network configured as described above.
• the management server 4 is equipped with a data acquisition unit 23-3 that acquires images of the patient from the data terminals 2 and 3, a patient database 28 as an image storage means that associates and stores the image of the patient acquired by the data acquisition unit 23-3 with the amount of the prescribed drug consumed that is delivered periodically, and an evaluation unit 23-5 as an analysis means that analyzes changes in the patient's symptoms based on the image of the patient stored in the patient database 28 and the amount of the prescribed drug consumed that is delivered periodically.
• a data acquisition unit 23-3 that acquires images of the patient from the data terminals 2 and 3
• a patient database 28 as an image storage means that associates and stores the image of the patient acquired by the data acquisition unit 23-3 with the amount of the prescribed drug consumed that is delivered periodically
• an evaluation unit 23-5 as an analysis means that analyzes changes in the patient's symptoms based on the image of the patient stored in the patient database 28 and the amount of the prescribed drug consumed that is delivered periodically.
• the amount of a specific drug injected into the ampoule AP can be increased or decreased based on the diagnostic findings specified by the specialist who diagnosed the patient.
• the data terminal 2 has a function for receiving a delivery schedule for ampoules filled with a specified drug that are delivered periodically from the management server 4, and a notification function for notifying the management server of the receipt status of ampoules filled with a specified drug that are delivered periodically.
• the images of the patient transmitted and received between data terminal 2 and data terminal 3 may consist of still images or moving images.
• the diagnostic findings of the specialist who operates the data terminal 3 are sufficient to determine whether or not an incurable disease that occurs during childhood has been improved by subcutaneous injection of beneficial exosomes that are effective against the disease.
• FIG. 4 to 8 are diagrams for explaining the configuration of a medicine kit transport tool used in the medicine distribution service system according to this embodiment.
• 40 is a transport unit that functions as a vacuum insulated cooler box, and stores the ampoule kit AK into which the probiotic exosomes described below have been injected and frozen while maintaining a frozen state at -80°C (storage period June to December).
• One ampoule kit AK contains five ampoules, but there is no limit to the number of ampoules.
• the transport unit 40 which is made up of a vacuum insulated cool box, has a three-layer structure, with the layers housing the lid 41, holder 43, and ice pack 42, and the holder 43 is configured to be able to hold four sets of ampoule kits AK (containing ampoules AP1 to AP4).
• a specific insulating material is placed inside the side walls of the vacuum insulated cool box 40, and it has a freezing temperature retention function that can maintain a temperature of -25°C or below for at least nine hours when storing items frozen at -50°C, for example.
• the delivery person removes the frozen ampoule kit AK from the holder 43 in the vacuum insulated cooler box 40 at the destination patient's home 6 and hands the ampoule kit over to the patient.
• the patient stores the delivered ampoule kit AK in a refrigerator equipped with a freezer 6A at home.
• the temperature of each ampoule in the ampoule kit AK rises from -80°C to -20°C (storage period 3 months), but this does not affect the efficacy of the drug.
• the transport unit 40 configured as described above has a temperature sensor at a predetermined position and has the function of transmitting the internal temperature of the ampule AP detected by the temperature sensor to an external device (e.g., the management server 4).
• an external device e.g., the management server 4
• the other layers can contain dry ice or granular ice as a cooling agent.
• Granular ice looks like sherbet-like snow at first glance, but contains a certain concentration of salt.
• the transport unit 40 has an inner layer of, for example, a three-layer structure, and identification information for specifying the destination is provided on the outer surface of the upper layer, so that a nurse who is caring for a patient can read the information using the camera function of a smartphone to confirm whether the ampoule kit is addressed to him or her.
• the transport unit 40 can be configured to include a component that transmits a GPS signal, thereby checking the transport route of the ampoule kit and notifying the waiting patient's home of the arrival time.
• the system may also include a function for controlling the handover of the ampoule kit to the nurse only when the identification information (e.g., a QR code (registered trademark)) attached to the transport unit 40 is photographed using the camera function of the data terminal 2 operated by the nurse who will be the recipient, and a notification (including an email notification, SNS, or SMS) of a transfer permission instruction is received from the management server 4 to the data terminal 7 operated by the delivery person.
• This makes it possible to prevent medical accidents that may occur when a delivery person mistakenly delivers an ampoule containing a drug other than that specified to a nurse at a delivery destination.
• FIG. 5 is a plan view showing an example of an ampoule kit AK to be stored in the holder 43 shown in FIG. 4.
• the number of kits is "4", but the number of kits may be any number between “1" and "10".
• AP-1 to AP-4 are ampoule enclosures, transparent polyethylene bags that are configured so that the convex and concave sides at the top fit together to allow for easy opening and sealing.
• Ampoule AP is assigned a serial number, storage period, storage temperature, and identification number.
• FIG. 6 is a perspective view illustrating the structure of the needle-free syringe according to this embodiment.
• the needleless syringe (injector) shown in this embodiment has a structure in which a holder 61 shown in (a) is provided with a pressing part 61A, and an ampoule AP shown in (b) is attached from the lower side of the holder 61.
• the ampoule AP is provided with a pressing nozzle 62 that presses the medicine, and with the tip side of the ampoule AP in close contact with, for example, the buttocks of a patient, the upper side of the pressing nozzle 62 is pressed by a spring set in the pressing part 61A of the holder 61, so that the medicine is sprayed against the patient's buttocks, completing the subcutaneous injection.
• FIG. 7 is an explanatory diagram showing a series of steps in an injection operation using the needle-free syringe according to this embodiment. Note that (the direction of the black triangle to the right) indicates the progress of the operation process. Furthermore, P1 to P8 each indicate an injection process.
• the ampoule AP is unopened and thawed at room temperature (15° C. to 25° C.) in tap water in a predetermined thawing device (P1).
• a safety ring (not shown) provided on the holder 61 constituting the injector portion is lowered (P2), and the lid of the reset box is closed to compress the spring (not shown) of the injector portion (P3).
• the lid of the reset box is opened to complete the compression of the injector portion spring (P4).
• the pre-injection operation is completed by pressing the nozzle against the patient's buttocks, which will be the injection point (P7). Note that in the example shown in Figure 7, this is written as 90 degrees, but precision is not required as long as a nurse familiar with the operation can accurately inject the medicine subcutaneously.
• the nurse caring for the patient presses the trigger of the holder pressing part 61 of the injector part to inject the medicine onto the surface of the patient's skin (holding the nozzle so that it is at approximately 90 degrees to the buttock plane) to complete the subcutaneous injection (P8).
• Figure 8 is a diagram explaining the process of subcutaneous injection into the affected area using the needleless syringe shown in Figure 7 and the penetration of the drug, where (a) is a diagram showing the injected side, and (b) is a diagram showing the cross-sectional view of the liquid (including exosomes) sprayed from the ampoule AP penetrating into the subcutaneous tissue.
• the nurse caring for the patient does not need to be aware of the needle when operating the needleless syringe, and can safely and securely complete the operation of injecting the necessary medication into the buttocks of the patient (child).
• the mother can use the camera function of the data terminal she operates to transmit images of the child's facial expression to a data terminal operated by a specialist doctor or to a management server, making it possible to visually check the child's recovery following the subcutaneous injection.
• Second Embodiment In the above embodiment, an example was described in which an ampoule kit is transported in a refrigerated state to a transport unit. However, since it is believed that many nurses are unsure about the operating procedures of the ampoule kit, a service function may be incorporated into the system that allows a nurse to connect to a specific URL and remove the ampoule from the transport unit and thaw it while checking the operating procedures via audio, video, etc., or while chatting, and then attach the thawed ampoule to an injector to smoothly complete a subcutaneous injection into the child's buttocks.
• a pharmaceutical distribution service system that distributes ampoules filled with a specified pharmaceutical drug from a needleless injection device in which the ampoules are attached to an injector to form a single unit, using a transport unit, wherein the transport unit has at least a three-layer structure to maintain the temperature of the ampoules filled with the specified pharmaceutical drug at or below a specified freezing temperature, and is characterized in that one layer has a cold air passage for circulating cold air toward the upper or lower layer and has the function of circulating cold air taken in from other layers.
• the transport unit is characterized by having a function of transmitting the temperature inside the ampoule chamber detected by a temperature sensor provided in the transport unit to an external device.
• the other layer is characterized in that it can contain dry ice or granular ice as a cooling agent.
• the ampoule is characterized in that it contains 0.1 to 1.0 milliliters of the specified drug.
• the tip surface of the ampoule is characterized by having a nozzle for subcutaneously injecting the specified drug.
• the specified drug is characterized in that it is a good exosome.
• the predetermined freezing temperature is -80 to -60°C.
• the outer surface of the upper layer of the three-layer structure is provided with identification information that identifies the shipping destination.
• the identification information is a code or a two-dimensional code that identifies the RF tag.
• the transport unit is characterized by having a component that transmits a GPS signal.
• a needleless injection device in which an ampule filled with a specific drug is attached to an injector and integrated with the device, characterized in that the device includes a transport unit for transporting a plurality of packages containing the ampules, and the ampules contained in the transport unit are transported to a registered destination in a state in which the ampules are repackaged in a medical kit at a temperature equal to or lower than a first freezing temperature, the ampules removed from the medical kit are stored in a storage facility at a second freezing temperature higher than the first freezing temperature, and the package removed from the storage facility is opened in a room temperature atmosphere and thawed to a temperature suitable for subcutaneous injection, and the removed ampule is attached to the injector.
• the ampoule is characterized in that it contains 0.1 to 1.0 milliliters of the specified drug.
• the tip surface of the ampoule is characterized by having a nozzle for subcutaneously injecting the specified drug.
• the specified drug is characterized in that it is a good exosome.
• the first freezing temperature is -80 to -60°C.
• the second freezing temperature is -25 to -15°C.
• a management system that manages the condition of a patient who has been injected subcutaneously with an ampule filled with a specified drug that is regularly delivered, a needleless injection device in which the ampule is attached to an injector, and a data terminal operated by a nurse who cares for the patient communicate with each other via a network
• the management server manages the condition of the patient
• the management server comprising: an acquisition means for acquiring an image of the patient from the data terminal; an image storage means for storing the image of the patient acquired by the acquisition means in association with the amount of consumption of the specified drug that is regularly delivered; and an analysis means for analyzing changes in the patient's symptoms based on the image of the patient stored in the image storage means and the amount of consumption of the specified drug that is regularly delivered.
• the amount of the specified drug to be injected into the ampoule is increased or decreased based on the diagnostic findings specified by the specialist who diagnosed the patient.
• the data terminal is characterized by having a receiving means for receiving a delivery schedule for ampoules filled with the specified medicine that are regularly delivered from the management server, and a notifying means for notifying the management server of the receipt status of the ampoules filled with the specified medicine that are regularly delivered.
• the image of the patient is a still image or a video image.

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Citations (5)

• 2024
  • 2024-02-06 WO PCT/JP2024/003890 patent/WO2024166905A1/ja not_active Ceased
  • 2024-02-06 JP JP2024507876A patent/JPWO2024166905A1/ja active Pending

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