WO2020045693A1 - Système de mesure et de gestion de la quantité d'entrée à usage général monté sur un bouton de réglage de dose pour dispositif d'injection de type stylo - Google Patents
Système de mesure et de gestion de la quantité d'entrée à usage général monté sur un bouton de réglage de dose pour dispositif d'injection de type stylo Download PDFInfo
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- WO2020045693A1 WO2020045693A1 PCT/KR2018/009879 KR2018009879W WO2020045693A1 WO 2020045693 A1 WO2020045693 A1 WO 2020045693A1 KR 2018009879 W KR2018009879 W KR 2018009879W WO 2020045693 A1 WO2020045693 A1 WO 2020045693A1
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- Prior art keywords
- dose
- setting knob
- dose setting
- pen
- injection device
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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
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31566—Means improving security or handling thereof
- A61M5/31568—Means keeping track of the total dose administered, e.g. since the cartridge was inserted
-
- 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
-
- 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
- A61M5/31—Details
-
- 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
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
-
- 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
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31525—Dosing
- A61M5/31528—Dosing by means of rotational movements, e.g. screw-thread mechanisms
-
- 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
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31545—Setting modes for dosing
- A61M5/31548—Mechanically operated dose setting member
- A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
-
- 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
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
- A61M5/3158—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by axially moving actuator operated by user, e.g. an injection button
-
- 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
-
- 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
- A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
-
- 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
- A61M5/31—Details
- A61M2005/3125—Details specific display means, e.g. to indicate dose setting
- A61M2005/3126—Specific display means related to dosing
-
- 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
- A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
Definitions
- the present invention relates to a dose setting knob-mounted general-purpose dose measurement and management system for a pen-type injection device, comprising: a pen-type injection device (1) in a dose measurement and management system mounted on the pen-type injection device (1) to measure the dose of a drug;
- the main body 110 is detachably coupled to the dose setting knob 12 of the 1) via the dose setting knob mounting portion 120; And, the body 110 is installed, the dose setting knob 12 Dose measuring sensor 130 for detecting and measuring any one or more of the rotational movement and the position movement movement of the; and the rotational movement and position of the dose setting knob 12 measured by the dose measuring sensor 130
- Main control unit 150 for calculating and administering the drug dose set by the dose setting knob 12 through any one or more of the movement movement to manage and display the infusion history information;
- It relates to a dose setting knob-mounted universal dose measurement and management system 100 for a pen-type injection device, characterized in that it comprises a.
- insulin which is a drug for treating diabetic metabolic disease
- the meal-type insulin is injected into the human body three times a day on an empty stomach before meals, which is intended to prevent a rapid rise in blood sugar of post-prandial diabetic metabolic disease, and the basic insulin gradually decreases the action of insulin in the body for 24 hours. It is insulin that is maintained.
- diabetes is a disease that occurs when the body does not make enough insulin or does not use insulin properly to convert blood sugar, ie, glucose into energy.
- blood sugar ie, glucose into energy.
- it should be injected at a predetermined time, so it is considered more important to inject insulin at a fixed time than to inject a dose.
- the infusion device includes a cartridge mounting portion in which a cartridge filled with insulin is mounted, and a pusher for pushing the cartridge to eject insulin through a discharge portion and injecting the same into a patient.
- Such a portable injection device is commonly referred to as an "insulin pen” and has advantages such as easy and convenient injection while going out compared to an insulin syringe, and accurate dosage can be injected by simple dial operation.
- an insulin pen As a patent document relating to such an insulin pen, a number of patent documents have been published, including a "pen-type drug injection device equipped with a dose setting and resetting mechanism (Korean Patent Publication No. 10-2016-0049538)".
- Such a manual portable injector has a characteristic that the dose setting knob 12 and the injection button 11 protrude or retract accordingly when the dose setting knob 12 is rotated in the process of setting the dose. Is common.
- the injection process has an operating characteristic that the dose setting knob 12, which has been protruded when the injection button 11 is pressed, is stored again while rotating (hereinafter, the case having such an operating characteristic is referred to as 'protrusion type'. ).
- the dose setting knob 12 does not have a separate injection button 11 at all, and is integrated with the injection button. There is even a manual portable injection device (hereinafter, the case having such operating characteristics is referred to as 'injection button integrated').
- 'injection button integrated' the case having such operating characteristics is referred to as 'injection button integrated'.
- the length of the operating part and the position / diameter / thickness of the dose setting knobs are all different, so it can only be manufactured to be applied to only one type of injection device to use universally The problem was that it was impossible at all. In addition, since only the axial movement of the dose setting knob can be detected, there is a problem in that the measurement accuracy is poor.
- the present invention solves the problems of the existing invention described above, and through the configuration to mount the dose measurement and management system to the dose setting knob, having a variety of specifications, shapes and sizes, while administering for the dose setting in its operating characteristics
- the protruding type of the injection button protrudes and the non-protruding disposable or reusable pen type injection device that does not protrude the injection button, as well as the injection button integrated disposable or
- the injection button integrated disposable or Like a reusable pen injection device it can be installed universally on all pen injection devices with various operating characteristics regardless of its size, shape and operation characteristics.
- pen-type injection device that can systematically manage the input history such as time
- the disposable or reusable pen-type injection device it is possible to set the operation range by measuring the zero point and the maximum position, and to provide a dosage-type knob-type universal input measurement and management system for the pen-type injection device that can measure the dosage more accurately. Let it be the subject.
- the pen-type injection device capable of more accurately measuring the dosage and systematically managing the effective input history
- the pen-type injection device capable of more accurately measuring the dosage and systematically managing the effective input history
- the dose setting knob-mounted general-purpose dose measurement and management system for a pen-type injection device of the present invention is mounted in a pen-type injection device 1 in the dose measurement and management system for measuring the dose of a drug
- a main body 110 detachably coupled to the dose setting knob 12 of the pen-type injection device 1 through the dose setting knob mounting unit 120; and installed on the main body 110, wherein the dose Dose measurement sensor 130 for detecting and measuring any one or more of the rotational movement and the position movement movement of the setting knob 12;
- the dose setting knob 12 measured by the dose measuring sensor 130 A main control unit 150 configured to calculate and manage the medication dose set by the dose setting knob 12 through any one or more of a rotational movement and a position movement movement of the infusion history information; Characterized in that comprises a.
- the main control unit 150 in the rotational movement and positional movement of the dose setting knob 12 measured by the dose measuring sensor 130, the rotational movement of the dose setting knob 12 is When the position movement of the dose setting knob 12 is detected in the direction of the pen-type injection device 1 without being detected, it is determined that the infusion process is started, and the dose measuring sensor 130 before then The drug dose is calculated through at least one of the rotational movement and the position movement movement of the dose setting knob 12.
- the main body 110 further includes an injection detection sensor 140 capable of detecting a state in which the injection button 11 is pressed to be pressed in the injection process, and the main controller 150 is When the injection button 11 is detected to be operated by the injection detection sensor 140, the rotation of the dose setting knob 12 measured by the dose measurement sensor 130 before then is detected.
- the drug dosage is calculated through one or more of exercise and position movement exercise.
- the injection operation button 110 is configured to press the injection button 11 in contact with the injection button 11 of the pen-type injection device (1) during the injection process;
- Dosage setting knob-mounted universal dosage measurement and management system for pen-type injection device characterized in that it further comprises a.
- the injection operation button 110 is configured to further include an injection detection sensor 140 capable of detecting a state in which the injection button 11 is operated to be pressed in the injection process, the main controller 150 ), When the injection button 11 is detected to be actuated to be pressed through the infusion detection sensor 140, the dose setting knob 12 measured by the dose measurement sensor 130 before then.
- the drug dose is calculated through any one or more of the rotational movement and the position movement movement of the.
- the main controller 150 when measuring the rotational movement of the dose setting knob 12 measured by the dose measuring sensor 130 in the dose setting process, the dose measuring sensor 130 Through the periodic deviation of the rotational speed of the dose setting knob 12 measured in, characterized in that for calculating the amount of rotation of the dose setting knob 12 spaced apart.
- the dose setting knob mounting portion 120 is installed along the inner surface of the main body 110, is configured to have the main body 110 is mounted to the dose setting knob 12 of various diameters and elasticity Being elastic mounting portion 121; Characterized in that further comprises.
- the main body 110 is composed of a first main body 110a and a combination 110b connected through the operation unit 112, the dose setting knob mounting portion 120, the first main body 110a Variable coupling means (122) for coupling the coupling unit 110b with each other to be mounted on the dose setting knob 12 of various diameters; Characterized in that further comprises a.
- the dose setting knob mounting portion 120 is elastic, a plurality of coupling ribs 125 inclined from the lower side of the main body 110 in the direction of the central axis (CA) of the pen-type injection device (1). ); And, coupled to the lower outer side of the coupling ribs 125, the coupling ribs 125 being configured to come into close contact with the dose setting knob 12 by approaching in the direction of the central axis CA when the mounting coupling is performed.
- Ring 126 Characterized in that further comprises a.
- a wireless communication unit 170 Characterized in that further comprises.
- the user terminal 200 characterized in that further comprises a camera 210, the user terminal 200, the pen-shaped scanning device 1 of the photographed through the camera 210
- the ampoule information regarding the type and dose of the drug injected according to the housing or the captured image of the insulin container 14 is extracted and transmitted to the main control unit 150 through the wireless communication unit 170.
- the dosage measurement and management system is configured to be mounted on the dosage setting knob to rotate the dosage setting knob for setting the dosage amount in various operating conditions and shapes while having various specifications, shapes and sizes.
- a protruding injection button protrudes and a non-protruding disposable or reusable pen injection device without protruding injection buttons, as well as a disposable injection or reusable pen injection device integrated with an injection button integrated with a dose setting knob and injection button.
- the pen-type injection device with various operating characteristics can be installed universally regardless of its size, shape, or operating characteristics.
- Dose setting knob for pen-type injection device that can be managed systematically The advantage is that it is possible to provide a dose measurement and management system.
- the operation range is set by measuring the zero point reference point and the maximum position, and the dosage setting for the pen-type injection device that enables more accurate dosage measurement.
- the pen-type injection device capable of more accurately measuring the dosage and systematically managing the effective input history It is an advantage that it is possible to provide a universal dosage measurement and management system equipped with a dose setting knob for the application.
- FIG. 1 is a view showing the configuration of a pen-type injection device according to an embodiment of the existing invention.
- FIG. 2 is a view showing the appearance of a conventional injection button-integrated pen-type injection device.
- FIG. 3 is an external view of a dose setting knob-mounted universal dose measurement and management system for a pen-type injection device according to an embodiment of the present invention.
- FIG. 4 is a cross-sectional view showing a state in which a dose setting knob-mounted universal dose measuring and management system for a pen-type injection device according to an embodiment of the present invention is mounted.
- FIG. 5 is an external view of a dose setting knob-mounted universal dose measurement and management system for a pen-type injection device according to a second embodiment of the present invention.
- FIG. 6 is a cross-sectional view showing a state in which a dose setting knob-mounted universal dose measurement and management system for a pen-type injection device according to a second embodiment of the present invention is mounted.
- FIG. 7 is a block diagram of a dosage setting knob-mounted universal dosage measurement and management system for a pen-type injection device according to an embodiment of the present invention.
- FIG. 8 A diagram showing a first embodiment of a dose setting knob mounting portion of the dose setting knob-mounted general-purpose dose measuring and management system for a pen-type injection device according to the present invention.
- Fig. 9 A diagram showing various mounting examples of the first embodiment of the dose setting knob mounting portion of the dose setting knob-mounted universal dose measuring and management system for a pen-type injection device according to the present invention.
- FIG. 11 is a view showing a second embodiment of a dose setting knob mounting portion of the dose setting knob-mounted universal dose measuring and management system for a pen-type injection device according to the present invention
- Fig. 12 shows various mounting examples of the second embodiment of the dose setting knob mounting portion of the dose setting knob-mounted universal dose measuring and management system for a pen-type injection device according to the present invention.
- Needle 16 Internal Needle Cap
- CA central axis
- 110a first body 110b: joined body
- first tooth portion 122b elastic mounting tooth band
- 3-axis acceleration sensor 132 3-axis gyro sensor
- the pen-type injection device 1 may have a variety of specifications, sizes, shapes, etc. as described above, and may be classified as disposable or reusable. In terms of scanning, they have something in common.
- FIG. 1 is an exploded view of, for example, a Sanofi Solostar (R), which is an exploded view of a pen-type injection device 1 that can represent an insulin injection pen.
- R Sanofi Solostar
- the pen-shaped injection device 1 of FIG. 1 is a pre-filled, disposable injection pen with a housing 10 and equipped with an insulin container 14 to which the needle 15 can be fixed.
- the needle is protected by an inner needle cap 16 and an outer needle cap 17, and consequently can be covered by the cap 18.
- the dose of insulin discharged from the pen-type injection device 1 can be selected by turning the dose setting knob 12, and the dose thus selected is, for example, a dose display in the form of a multiple of the so-called international unit (IU). Or via display 13, where 1 IU is the biological equivalent of about 45.5 micrograms of pure crystalline insulin (1/22 mg).
- An example of a selected dose displayed in the dose display window or display 13 may be, for example, 30 IU as shown in FIG. 1.
- the selected dose may be displayed differently, for example by an electronic display. It will be appreciated that the dosage display relates to the portion of the injection device in which the selected dosage can be visually seen through or over it.
- the dose setting knob 12 generates a mechanical click sound, giving the user acoustic feedback.
- the numbers shown in the dose indication window or display 13 are printed on the sleeve which is housed in the housing 10 and which mechanically interacts with the piston in the insulin container 14.
- the process of setting the dose by turning the dose setting knob 12 may both increase or decrease the dose, in which case the sleeve may be raised or raised with rotation of the dose setting knob 12. Although this characteristic is lowered (this characteristic is shown by a dotted line in FIG. 1, and thus has an operating characteristic of "protrusion type"), the scanning liquid is not discharged in a state where the scanning button 11 is not pressed.
- the needle 15 is inserted into the patient's skin and then the injection button 11 is pressed, the injection button 11 is pushed in a predetermined distance and then advanced together with the sleeve and the insulin dose displayed on the display 13 is not until the injection device is released. It is discharged from (1).
- the injection button 11 is pressed, if the needle 15 of the injection device 1 remains inside the skin portion for a certain time, a large amount of dose is actually injected into the patient's body. Mechanical click sounds also occur when the insulin dose is dispensed, but this is different from the sound produced when using the dose setting knob 12.
- the injection device 1 can be used for several injection procedures until the insulin container 14 is completely empty or until the expiration date of the injection device 1 (eg 28 days after first use).
- the dose setting knob 12 does not provide a separate injection button 11 at all. Configured to perform together.
- a dosage setting knob-mounted universal dose measurement and management system for a pen-type injection device will be described in detail.
- Dosage setting knob-mounted universal dose measurement and management system for a pen-type injection device according to an embodiment of the present invention as shown in Figure 3 or 5, the body 110, the dosage setting knob mounting unit 120, the dosage Characterized by comprising a measurement sensor 130 and the main controller 150.
- the main body 110 will be described. 3 or 5, the main body 110 is configured to be detachably coupled to the dose setting knob 12 of the pen-type injection device 1 through the dose setting knob mount 120.
- the dose setting knob 12 is attached to the main body 110 as shown in FIGS. 3 and 4. It is possible to form a through-hole that can be inserted and coupled.
- the main body 110 when mounted in a pen-type injection device having a separate injection button 11 as shown in Figure 1, the main body 110, as shown in (A) in Figure 4, to the upper side of the main body 110
- the scan button 11 is preferably configured to protrude out. This arrangement is particularly advantageous when the dose setting knob-mounted universal dose measurement and management system of the present invention is miniaturized and implemented.
- the main body 110 is mounted on an injection button integrated pen type injection device as shown in Fig. 2, as shown in Fig. 4B, the main body 110 has the dose setting knob 12 It is also possible to be configured in a shape that completely covers the.
- the main body 110 is an operation unit 112 as shown in Figure 9 so that it can be universally mounted to the dose setting knob 12 having a variety of diameters according to the type of the pen-type injection device (1) It is possible to be composed of the first body (110a) and the coupling body (110b) connected through.
- the dose setting knob mounting portion 120 is configured through the variable body coupling means 122 as described below, it is to be universally mounted and fixed to the dose setting knob 12 having a variety of diameters It becomes possible.
- injection button (110) configured to contact the injection button (11) of the pen-type injection device (1) to press the injection button (11) in the process; It is possible to be configured to include more.
- the dose setting knob mounting unit 120 has a function of detachably coupling the main body 110 to the dose setting knob 12.
- the dose setting knob mounting portion 120 may be formed to be in close contact with the dose setting knob 12 on the inner surface of the body 110.
- the dose setting knob mounting portion 120 is installed along the inner surface of the body 110, as shown in Figure 4, and has the elasticity and the body ( It is preferable to further comprise an elastic mounting portion 121 is configured to be mounted 110.
- the main body 110 as shown in Figure 8 which is a cross-sectional view when viewed from the upper side as shown in FIG.
- the first body 110a and the combiner 110b are connected to each other, and the dose setting knob mounting unit 120 combines the first main body 110a and the combiner 110b to each other to administer the various diameters.
- the operation unit 112 is integrally formed with a material having elasticity together with the first body 110a and the assembly 110b, so that the first body 110a and the assembly 110b approach each other. It is preferably formed to have elasticity in the direction.
- variable coupling means 122 can also be implemented in a wide variety of embodiments. In such embodiments, it is possible to select any of the configurations that can be fastened while adjusting the length of engagement using a Velcro or a coupling band provided with a magnet.
- variable coupling means 122 as shown in Figure 8 or 9, is formed in any one of the first body (110a) or the combination (110b), inclined in one direction A resilient mounting tooth band 122b having a first tooth portion 122a formed therein, and a length formed at another one of the first main body 110a or the coupling body 110b and coupled to the first tooth portion 122a.
- variable coupling means 122 when the operating unit 112 is formed to have sufficient elasticity in the direction in which the first body (110a) and the assembly (110b) approaches each other, the variable coupling means 122 to be configured to omit It is also possible. That is, when the operating unit 112 provides sufficient elasticity in the direction in which the first body 110a and the assembly 110b approach each other, the user separately moves the body 110 to the dose setting knob 12.
- the main body 110 may be stably mounted to the dose setting knob 12 by sufficient elasticity unless it is removed.
- the dose setting knob mounting portion 120 having the above-described configuration, as shown in (A) of FIG. 9, it is possible to attach to the dose setting knob 12 having a small diameter. It is also possible to mount to the dose setting knob 12 having a large diameter as shown in (B) in, it is possible to universally mount to the dose setting knob 12 of various sizes.
- the dose setting knob mounting unit 120 has elasticity and is formed with a plurality of coupling ribs 125 inclined from the lower side of the main body 110 in the direction of the central axis CA of the pen-type injection device 1. And coupled to the lower outer side of the coupling ribs 125, the coupling ribs 125 being in close contact with the dose setting knob 12 when approaching the coupling ribs 125 in the direction of the central axis CA. It is possible to further comprise a coupling ring 126.
- the mounting ring 126 is an embodiment in which the coupling ribs 125 are brought into close contact with the dose setting knob 12 in the direction of the central axis (CA) in the mounting coupling, FIG.
- the outer side of the coupling ribs 125 is formed so that the coupling rib threaded portion (125a) is formed, the inner side of the coupling ring 126 to the coupling rib threaded portion (125a) It is possible to configure such that the engagement ring threaded portion 126a is formed. According to this configuration, as shown in FIG.
- the coupling ring 126 approaches the coupling ribs 125 in the direction of the central axis CA so that the coupling ring 126 comes into close contact with the dose setting knob 12.
- a coupling fastening depression 125c is further formed at an outer upper end of each of the coupling ribs 125, and a coupling ring coupling protrusion 126b is formed inside the coupling ring 126. It is possible to further form).
- the coupling ribs 126 are inclined toward the central axis CA, respectively.
- the lower ends of the coupling ribs 125 are operated to approach in the direction of the central axis CA, respectively, as they ride up the 125. Meanwhile, in the state in which the coupling ring 126 is raised as much as possible, the coupling ring coupling protrusion 126b may be inserted into the coupling coupling depression 125c and the coupling ring 126 may be fixed.
- the lower end of each of the resilient coupling ribs 125 is in close contact with the dose setting knob 12 and consequently the main body 110 for the dose setting knob 12 having various diameters. Correspondingly, it is possible to fix it universally.
- the coupling ring 126 is preferably formed on the outer end of the lower end of each of the coupling ribs 125 so that the coupling ring drop prevention protrusion 125b is further formed so that the coupling ring 126 is not completely separated.
- the dose measuring sensor 130 is installed in the main body 110, and is implemented to detect and measure any one or more of a rotational movement and a position movement movement of the dose setting knob 12.
- the dose measuring sensor 130 includes a three-axis acceleration sensor 131 as shown in FIG. 7. It is preferable to be configured.
- the three-axis acceleration sensor 131 is a sensor for detecting the acceleration in the x-axis, y-axis, and z-axis direction in a three-dimensional space, by using the acceleration value in the three-axis direction measured in this way Integral operations can be used to measure velocity and displacement.
- the dose sensor 130 is preferably configured to further comprise a three-axis gyro sensor 132.
- a three-axis gyro sensor 132 As described above, when the three-axis acceleration sensor 131 and the three-axis gyro sensor 132 are used together, the x-axis along with the acceleration / speed / displacement in the x-axis, y-axis, and z-axis directions in three-dimensional space It is possible to measure the angular acceleration / angular velocity / rotation angle with each of the rotational axes, y-axis, and z-axis as the rotational axes, and as a result, it is possible to accurately measure both the rotational motion and the positional movement motion in three-dimensional space.
- the dose setting process is performed in a relatively short set-up time (typically within a few seconds to 1 minute), the total amount of rotation during that time is also a few turns, the position movement is also within a few centimeters, the three-axis acceleration
- the configuration using the sensor 131 and the three-axis gyro sensor 132 can ensure a sufficient precision for measuring the rotational movement and the position movement movement of the dose setting knob 12.
- no mechanical interlocking component for operation is required, such mechanical interlocking configuration There is no room for measurement error due to factors, and it is advantageous in that it is not influenced by external factors such as ambient noise or contrast.
- the dose measuring sensor 130 is preferably configured to further comprise a temperature sensor 133. That is, depending on the characteristics of the user, there may be a case where the pen-type injection device 1 is stored and used in a refrigerator or the like while the dose setting knob-mounted universal dose measurement and management system 100 of the present invention is mounted. have.
- the measurement characteristics of the three-axis acceleration sensor 131 and the three-axis gyro sensor 132 may change according to the temperature change, by using the temperature measured through the temperature sensor 133 to the temperature It is desirable to be able to correct the measured value in consideration of the change in measurement characteristics.
- the infusion detection sensor 140 has a function of detecting that the injection button 11 is operated to be pressed during the infusion process, so as to detect the completion of the dose setting process up to that point. It is configured to. That is, in the dose setting process, the user operates the dose setting knob 12 to increase or decrease the dose, and this dose setting operation may be repeatedly performed several times. Thus, when this dose setting process is terminated and infusion is initiated, the dose set just before the infusion is initiated becomes the actual dose. Therefore, it is important to detect this injection process. To this end, the injection process may be started through the operation method of the main controller 150 according to the operating characteristics of the pen-type injection device 1 as described below, but the injection detection sensor 140 may be It is also possible to detect the start of the injection process directly.
- the injection detection sensor 140 is preferably configured so that the user can detect a state in which a finger touches or a pressure is applied in order to press the injection button 11, a touch sensor or pressure that can usually detect the touch It is possible to be spherical through the crimping sensor that can detect the.
- the injection detection sensor 140 may be installed to be exposed to the upper side of the main body 110 as shown in FIG. 3. That is, when the user starts the injection process, it is possible to be installed in the main body 110 of the contacted or compressed portion when the user presses with a finger.
- the injection detection sensor 140 when the main body 110 is provided with a separate injection operation button 111 as shown in Figure 5, the injection detection sensor 140 is the injection It is preferable to be provided above the operation button 111.
- the main controller 150 may control the dose setting knob through at least one of rotational movement and positional movement of the dose setting knob 12 measured by the dose detecting sensor 130. It is configured to perform a function of calculating and administering the drug dosage set in 12 to manage and display the infusion history information. That is, the actual drug dosage is determined according to any one or more of the rotational position variation or positional variation of the dose setting knob 12 set during the dose setting process. Therefore, by measuring any one or more of the rotational position change or positional change of the dose setting knob 12 set before the start of administration, it is possible to calculate the drug dose based on this.
- the main control unit 150 stores and manages the infusion history information including each drug dose and infusion time so that the history management can be performed in the case of a diabetic agent in which systematic and cumulative administration history is important. It is desirable to.
- the main controller 150 may be configured to operate in other ways as follows.
- the dose setting knob 12 sets the dose while protruding or retracting while rotating
- the dose rotating knob 12 has an operating characteristic that operates to be retracted without rotation.
- the main control unit 150 rotates the dose setting knob 12 in the rotational movement and positional movement of the dose setting knob 12 measured by the dose measuring sensor 130.
- the position movement of the dose setting knob 12 is detected in the direction of the pen-type injection device 1 (ie, in the direction of receiving) without being detected, it is determined that the injection process is started. It is preferable to calculate the drug dose through any one or more of the rotational movement and positional movement of the dose setting knob 12 measured by the dose measuring sensor 130 up to that point.
- the main control unit 150 is operated so that the injection button 11 is pressed through the injection detection sensor 140. It is possible to calculate the drug dose via any one or more of rotational movement and positional movement of the dose setting knob 12 measured by the dose measuring sensor 130 up to now. .
- the pen-type injection device 1 is such that the rotational operation of the dose setting knob 12 intermittently generates a mechanical click sound in the dose setting process for each unit of the injection dose that can be set according to the mechanical configuration feature.
- the rotational movement of the dose setting knob 12 is characterized in that a variation in speed occurs for each unit of the injection dose as shown in FIG. 8 in the rotational speed thereof.
- the dose measuring sensor Through the periodic deviation of the rotational speed of the dose setting knob 12 measured at 130, the amount of rotation of the dose setting knob 12 is spaced apart (that is, the It is preferably configured to calculate (in units of scan doses settable) according to the characteristics of the mechanical configuration.
- the main controller 150 may further be connected to an input / output interface 160 that receives a user's operation input and displays an operation state.
- the input / output interface 160 may be implemented in various embodiments.
- the input / output interface 160 may include a display 161 indicating an operation state, as shown in FIG. It may be configured to include an operation switch 162 for receiving a user's operation input, such as administration dose setting.
- the display 161 and the operation switch 162 may be integrally implemented through a touch screen display.
- the input / output interface 160 further includes sound output means 163 for outputting a warning sound or a notification sound, as shown in FIG.
- the main control unit 150 includes the user terminal 200 through the communication network N as shown in FIG. 7. It is preferable that the wireless communication unit 170 is connected to any one or more of the medical institution server 300 and the guardian terminal 400 to transmit the injection history information.
- the user terminal 200 and the guardian terminal 400 may be a personal computer, a portable terminal, or an internet of things based terminal.
- the user terminal 200 and the guardian terminal 400 are illustrated in a shape similar to a smart phone, but the spirit of the present invention is not limited thereto, and the terminal equipped with the terminal application as described above. May be borrowed without limitation.
- the user terminal 200 and the guardian terminal 400 may include a computer (eg, desktop, laptop, tablet, etc.), a media computing platform (eg, cable, satellite set-top box, digital video). Recorder), handheld computing device (e.g., PDA, email client, etc.), any form of cellular phone, any form of other type of computing or communication platform, but the present invention is not limited thereto.
- the user terminal 200 may be configured to include a continuous glucose monitoring (CGM) system.
- CGM continuous glucose monitoring
- the communication network N serves to connect any one or more of the user terminal 200, the medical institution server 300, and the guardian terminal 400 with the wireless communication unit 170. That is, the communication network (N) is a communication network that provides a connection path so that any one or more of the user terminal 200, medical institution server 300 and the guardian terminal 400 and the wireless communication unit 170 can transmit and receive data. Means.
- the communication network (N) is, for example, wired networks such as LANs (Local Area Networks), Wide Area Networks (WANs), Metropolitan Area Networks (MANs), Integrated Service Digital Networks (ISDNs), or wireless LANs, CDMA, Bluetooth, satellite communications. Although it may include a wireless network such as, but the scope of the present invention is not limited thereto.
- the user terminal 200 is preferably configured to further include a camera 210 as shown in FIG.
- the user terminal 200 is printed with the image of the housing of the pen-type injection device 1 or the insulin container 14 photographed through the camera 210 (in particular, a barcode or QR code). Extracting ampoule information regarding the type and dosage of the drug to be injected and delivering the ampoule information to the main control unit 150 through the wireless communication unit 170.
- the ampoule information delivered as described above may be included in the infusion history information and managed, as well as being useful in the setting operation process or drug dosage calculation process to be described later.
- the dose setting knob-mounted universal dose measurement and management system for a pen-type injection device is preferably performed first before use (S10).
- the setting process (S10) is once mounted to the dose setting knob 12 of the pen-type injection device 1, the main body 110 of the dose setting knob-mounted universal dosage measurement and management system 100 for pen-type injection device, After turning the dose setting knob 12 to the minimum value (ie, the dose '0') in the direction set, the first position of the main body 110 was measured through the dose detection sensor 130 (S11). After that, it is set as the zero reference position.
- the dose setting knob 12 is rotated to set the maximum injection dose, and then the position at the maximum injection dose of the main body 110 is measured through the dose detection sensor 130 in the state ( S12).
- the maximum injection dose is given in advance according to the type / standard of the pen-type injection device 1 used.
- the ampoule information including the dose of the drug stored in the insulin container 14 it is also possible to receive and provide through the ampoule information extraction process (S30) through the user terminal 200 as shown in FIG. That is, the user terminal 200 captures a captured image (particularly, a barcode or QR code portion, etc.) of the housing of the pen-type injection device 1 or the insulin container 14 through the camera 210 ( S31). Thereafter, the image is processed (S32), and the ampoule corresponding to the photographed image among the ampoule information of various manufacturers / types of drugs / insulin container ampoules stored in the database 240 of the user terminal 200. Search for the information (S33), extract the corresponding ampoule information (S34) and then transfer it to the main control unit 150 through the wireless communication unit 170 using the communication network (N), more conveniently and quickly It is also possible to proceed with the setting process (S10).
- S30 the ampoule information extraction process
- any one or more of the position or rotational position of the measurement knob 130 is continuously measured through the dose detection sensor 130 (S21).
- the injection button 11 when the injection button 11 is pressed for the injection, the injection process is started through the operating characteristics in the injection process detected by the injection detection sensor 140 or the dose detection sensor 130, the injection button It is determined that (11) is pressed and the administration is started (S22), and any one of the position or rotational position of the dose setting knob 12 until the start of administration measured through the dose sensor 130 is detected. Using the above, the dosage is calculated by calculation (S23).
- the drug dosage and the dosing time measured in this way are managed by the universally mounted dose measurement and management system 100 itself as injection history information (S40), or through the communication network (N), the user terminal 200 and the medical institution server ( It may be delivered to any one or more of the 300 and the guardian terminal 400 may be managed by an external device (S50).
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Abstract
La présente invention concerne un système de mesure et de gestion de la quantité d'entrée à usage général monté sur un bouton de réglage de dose pour dispositif d'injection de type stylo, où le système est monté sur un dispositif d'injection de type stylo pour mesurer une quantité d'entrée d'un médicament. Le système de mesure et de gestion de la quantité d'entrée à usage général monté sur un bouton de réglage de dose pour dispositif d'injection de type stylo comprend : un corps accouplé de manière détachable à un bouton de réglage de dose d'un dispositif d'injection de type stylo à l'aide d'une pièce de montage de bouton de réglage de dose ; un capteur de mesure de dose installé dans le corps, et la détection et la mesure d'au moins l'un du mouvement de rotation et du mouvement de décalage de position du bouton de réglage de dose ; et une unité de commande principale pour calculer une dose de médicament ayant été définie par le bouton de réglage de dose, sur la base d'au moins l'un du mouvement de rotation et du mouvement de décalage de position du bouton de réglage de dose, qui ont été mesurés par le capteur de mesure de dose, afin de gérer et d'afficher la dose comme informations d'historique d'injection.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR10-2018-0100277 | 2018-08-27 | ||
| KR1020180100277A KR20200023850A (ko) | 2018-08-27 | 2018-08-27 | 펜형 주사장치의 투여량 설정 노브 장착형 범용 투입량 측정 및 관리 시스템 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2020045693A1 true WO2020045693A1 (fr) | 2020-03-05 |
Family
ID=69643135
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/KR2018/009879 Ceased WO2020045693A1 (fr) | 2018-08-27 | 2018-08-27 | Système de mesure et de gestion de la quantité d'entrée à usage général monté sur un bouton de réglage de dose pour dispositif d'injection de type stylo |
Country Status (2)
| Country | Link |
|---|---|
| KR (1) | KR20200023850A (fr) |
| WO (1) | WO2020045693A1 (fr) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023280419A1 (fr) * | 2021-07-09 | 2023-01-12 | Sanofi | Appareil de collecte de données pour détermination de dose |
| CN116139369A (zh) * | 2023-03-06 | 2023-05-23 | 仲伟营 | 用于检测从注射装置递送的药剂剂量的设备 |
| WO2023160304A1 (fr) * | 2022-02-22 | 2023-08-31 | 上海微创生命科技有限公司 | Appareil d'acquisition de quantité d'injection et système d'injection d'insuline |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR102657616B1 (ko) | 2022-06-20 | 2024-04-12 | 안영환 | 2중 아이엠유 센서를 이용한 펜형 주사장치의 범용 투입량 측정 및 관리 시스템 |
| KR102787877B1 (ko) * | 2022-12-26 | 2025-03-31 | 주식회사 푸른소나무 | 약물 주입 기록 장치 |
| KR102787881B1 (ko) * | 2022-12-26 | 2025-03-31 | 주식회사 푸른소나무 | 약물 주입 기록 장치 |
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| TW201521810A (zh) | 2013-09-03 | 2015-06-16 | Sanofi Sa | 驅動機構 |
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- 2018-08-27 WO PCT/KR2018/009879 patent/WO2020045693A1/fr not_active Ceased
- 2018-08-27 KR KR1020180100277A patent/KR20200023850A/ko not_active Ceased
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| US20050043676A1 (en) * | 2002-02-01 | 2005-02-24 | Axel Remde | Means for administering an injectable product in doses |
| JP2012519026A (ja) * | 2009-02-27 | 2012-08-23 | ライフスキャン・インコーポレイテッド | 薬物送達システム |
| JP2015511835A (ja) * | 2012-02-13 | 2015-04-23 | サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | 手動で動作可能な注射デバイス向けの補助デバイス |
| JP2017507735A (ja) * | 2014-03-12 | 2017-03-23 | アセンシア・ディアベティス・ケア・ホールディングス・アーゲー | 薬剤搬送デバイスを増強するための方法および装置 |
| KR20180076034A (ko) * | 2016-12-27 | 2018-07-05 | 최규동 | 펜형 주사장치의 범용 장착형 투입량 측정 및 관리 시스템 |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023280419A1 (fr) * | 2021-07-09 | 2023-01-12 | Sanofi | Appareil de collecte de données pour détermination de dose |
| WO2023160304A1 (fr) * | 2022-02-22 | 2023-08-31 | 上海微创生命科技有限公司 | Appareil d'acquisition de quantité d'injection et système d'injection d'insuline |
| CN116139369A (zh) * | 2023-03-06 | 2023-05-23 | 仲伟营 | 用于检测从注射装置递送的药剂剂量的设备 |
| CN116139369B (zh) * | 2023-03-06 | 2023-08-18 | 仲伟营 | 用于检测从注射装置递送的药剂剂量的设备 |
Also Published As
| Publication number | Publication date |
|---|---|
| KR20200023850A (ko) | 2020-03-06 |
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