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WO2025221053A1 - Dispositif d'injection de médicament - Google Patents

Dispositif d'injection de médicament

Info

Publication number
WO2025221053A1
WO2025221053A1 PCT/KR2025/005230 KR2025005230W WO2025221053A1 WO 2025221053 A1 WO2025221053 A1 WO 2025221053A1 KR 2025005230 W KR2025005230 W KR 2025005230W WO 2025221053 A1 WO2025221053 A1 WO 2025221053A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
drug injection
protection cap
injection device
patch
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/KR2025/005230
Other languages
English (en)
Korean (ko)
Inventor
진명호
김재우
황철진
주은화
신운섭
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sogang University Research Foundation
CareMedi Co Ltd
Original Assignee
Sogang University Research Foundation
CareMedi Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from KR1020250033130A external-priority patent/KR20250154231A/ko
Application filed by Sogang University Research Foundation, CareMedi Co Ltd filed Critical Sogang University Research Foundation
Publication of WO2025221053A1 publication Critical patent/WO2025221053A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube

Definitions

  • the present invention relates to a patch-type drug injection device.
  • medications can be administered orally, subcutaneously, or intravenously.
  • Drug infusion devices utilizing drug pumps can automatically inject medication into the body at the desired rate and dose at the required time. Therefore, drug infusion devices utilizing drug pumps can be utilized in a variety of ways, not just in hospitals or patients' daily lives.
  • An insulin pump commonly called an insulin injector, is a medical device that acts like a pancreas to control blood sugar levels by supplying insulin from outside the body at a set time precisely for diabetic patients who do not secrete insulin or secrete only a small amount.
  • insulin pumps are used by patients with insulin-dependent diabetes, and can deliver medication continuously 24 hours a day while attached to the patient. Because insulin injectors require patients to administer medication periodically over long periods of time, active technology development is underway to miniaturize and automate insulin injectors for greater user convenience.
  • Insulin injectors are generally attached to the user's body for a specified period of use.
  • the process of operating the insulin injector and attaching it to the user can be somewhat complicated, so a technology is needed to guide the user through the initial process of operating the insulin injector so that the user can handle it easily.
  • the present invention provides a drug injection device capable of guiding an initial process for operating the drug injection device through a needle protection cap coupled to a needle of an injection assembly for injecting a drug.
  • a patch-type drug injection device comprises: a housing including a cover part and a contact surface; a needle discharge port formed in an area of the contact surface; a power button disposed adjacent to the needle discharge port on the contact surface; a drug injection port formed adjacent to the needle discharge port on the contact surface; and a needle protection cap formed to have a predetermined area, coupled to the needle discharge port, and selectively detachable from the needle discharge port, wherein the needle protection cap is formed to cover the needle discharge port and the power button when coupled to the needle discharge port.
  • the needle is protected through a needle protection cap, and the user can easily attach the drug injection device to the body by intuitively guiding the user through the sequence until the drug injection device is attached to the user.
  • FIG. 1 is a front perspective view of a drug injection device according to one embodiment of the present invention.
  • Figures 2 and 3 are rear plan views of a drug injection device according to one embodiment of the present invention.
  • Figure 4 is an inner plan view of the needle protection cap illustrated in Figure 3.
  • FIG. 5 is a rear plan view of a drug injection device with a needle protection cap attached according to another embodiment of the present invention.
  • Figure 6 is an inner plan view of the needle protection cap illustrated in Figure 5.
  • Figure 7 is a drawing showing a sequence mark printed on a needle protection cap according to another embodiment of the present invention.
  • Figure 8 is an exploded perspective view of the housing illustrated in Figure 1.
  • Figure 9 is a block diagram schematically showing the configuration of the pump assembly illustrated in Figure 8.
  • Fig. 10 is a block diagram schematically showing the configuration of the driving unit illustrated in Fig. 9.
  • Fig. 11 is an example diagram schematically showing the operation of the driving unit illustrated in Fig. 10.
  • Figure 12 is a perspective view of the injection assembly illustrated in Figure 8.
  • ordinal terms such as “first,” “second,” etc. are used solely to distinguish one component from another and do not limit the order or relationship of the components.
  • first component of the present invention may be referred to as the "second component”
  • second component may also be referred to as the "first component.”
  • FIG. 1 is a front perspective view of a drug injection device according to an embodiment of the present invention
  • FIGS. 2 and 3 are rear plan views of the drug injection device according to an embodiment of the present invention.
  • the patch-type drug injection device (100) includes a housing (110) and components arranged inside the housing (110).
  • the housing (110) includes a cover portion (111) and a contact surface (112), and a mounting space is formed between the cover portion (111) and the contact surface (112).
  • the cover portion (111) has rounded corners, so that the patch-type drug injection device (100) can be continuously attached to the injection target without a foreign body sensation.
  • the contact surface (112) is configured to be attached to an injection target, and includes a needle discharge port (112a) formed in one area, a power button (112b) positioned adjacent to the needle discharge port (112a), a drug injection port (112c) positioned adjacent to the needle discharge port (112a), and a needle protection cap fastening groove (112d).
  • the needle discharge port (112a) is for protruding a needle through which a drug is injected into the injection target to the outside, and a silicone cap can be coupled to the needle discharge port (112a) to fix the needle.
  • the drug injection port (112c) is formed on the opposite side of the power button (112b) with respect to the needle discharge port (112a).
  • the housing (110) is coupled with a needle protection cap (113).
  • the needle protection cap (113) is formed to have a predetermined area, is coupled to the needle discharge port (112a), and is selectively detachable from the needle discharge port (112a).
  • the needle protection cap (113) is formed to cover the needle discharge port (112a) and the power button (112b).
  • the drug injection port (112c) is not covered by the needle protection cap (113).
  • the needle protection cap (113) covers the power button (112b), and the drug injection port (112c) is maintained in an exposed state, thereby guiding the user to first perform a drug injection procedure for the drug injection port (112c).
  • Fig. 4 is a rear perspective view of the needle protection cap illustrated in Fig. 3.
  • the needle protection cap (113) may have an insertion tube (113a) formed on the inner surface thereof, which is coupled with a needle outlet (112a).
  • the insertion tube (113a) is formed to protrude from the inner surface of the needle protection cap (113), and when the insertion tube (113a) is coupled to the needle outlet (112a), the needle penetrates the center of the insertion tube (113a) and is placed within the insertion tube (113a). With this structure, the needle can be safely protected within the space within the insertion tube (113a) of the needle protection cap (113).
  • a rubber material finishing component (113b) that increases the sealing force when inserting the insertion tube (113a) may be combined on the outside of the insertion tube (113a).
  • the needle protection cap (113) may have an air filter (114) combined on the outer surface facing the insertion tube (113a). The air filter (114) closes the internal space where the needle of the insertion tube (113a) is placed, and communicates air with the inside of the drug injection device (100) through the needle outlet (112a). Through this, a sterilizing gas can be introduced into the inside of the drug injection device (100) to sterilize the needle.
  • the needle protection cap (113) has a fastening protrusion (113c) formed on the inner surface, and the fastening protrusion (113c) is inserted into a fastening groove (112d) formed on the contact surface (112) to be coupled with the needle discharge port (112a). Accordingly, the needle protection cap (113) can be coupled and fixed to the contact surface (112) of the drug injection device (100).
  • the needle protection cap (113) can be implemented in a form in which the fastening protrusion (113c) is formed on the contact surface (112), and a fastening groove (112d) is formed on the inner surface of the needle protection cap (113).
  • the needle protection cap (113) may be formed with a grip portion (113d) on one side for easy removal.
  • the grip portion (113d) is formed in a dome shape so that the user's fingertips can enter when removing the needle protection cap (113), thereby making it easy to remove the needle protection cap (113).
  • the contact surface (112) includes an adhesive sheet so as to be attached to an injection target, and a release sheet (112e) is attached to the adhesive sheet.
  • the release sheet (112e) may include a sequence mark printed adjacent to the drug injection port (112a), the needle protection cap (113), and the power button (112b).
  • the sequence mark guides the initial operation of the drug injection device (100), and may include a first sequence mark (1) guiding the injection of a drug into the drug injection port (112c), a second sequence mark (2) guiding the removal of the needle protection cap (113), and a third sequence mark (3) guiding the pressing of the power button (112b).
  • the order markings may be printed on one side of the needle protection cap (113) and the release liner (112e).
  • the first order marking (1) and the second order marking (2) may be printed on a portion adjacent to the drug injection port (112a) and the grip portion (113d) of one side of the needle protection cap (113), and the third order marking (3) may be printed on a portion adjacent to the power button (112b) of the surface of the release liner (112e).
  • the user can operate the drug injection device (100) by first injecting the drug through the drug injection port (112c) according to the first order indication (1), removing the needle protection cap (113) according to the second order indication (2), and then pressing the power button (112b) according to the third order indication (3).
  • the release paper (112e) When the initial operation of the drug injection device (100) is completed through the sequence display, the release paper (112e) is removed and attached to the injection target.
  • the release paper (112e) may have a pre-processed cut portion formed in the center so that only a portion can be removed, and a guide portion exposed to the outside may be formed to facilitate removal.
  • FIG. 5 is a rear plan view of a drug injection device with a needle protection cap attached according to another embodiment of the present invention
  • FIG. 6 is an inner plan view of the needle protection cap illustrated in FIG. 5.
  • a needle protection cap (113) according to another embodiment of the present invention is formed larger than the needle protection cap (113) illustrated in FIG. 3 to cover the drug injection port (112c), and a drug injection hole (115) can be formed at a position corresponding to the drug injection port (112c).
  • a drug injection hole (115) may be formed in the needle protection cap (113) in an area corresponding to the area where the drug injection port (112c) is arranged.
  • the needle protection cap (113) when the needle protection cap (113) is coupled to the needle discharge port (112a), it may be formed to cover the needle discharge port (112a), the power button (112b), and the drug injection port (112c).
  • a user can inject a drug into the drug injection port (112c) by penetrating the drug injection hole (115) while the needle protection cap (113) is coupled.
  • Fig. 8 is an exploded perspective view of the housing illustrated in Fig. 1.
  • the mounting space formed in the housing (110) expands in a direction perpendicular to the insertion direction of the needle, and major components are combined.
  • the PCB circuit part is first arranged over the entire or most of the plane of the device, and then the drug storage part or pump, etc. are arranged on top of it, so there is a problem that the thickness of the device is formed thick.
  • the patch-type drug injection device (100) of the present invention the area where each component overlaps with each other is minimized.
  • the components may include a drug storage unit (120), a pump assembly (130), a circuit unit (140), and an injection assembly (150).
  • the arrangement structure of each component may be such that the injection assembly (150) is arranged in the central region, and the drug storage unit (120), the pump assembly (130), and the circuit unit (140) are arranged in a form surrounding the injection assembly (150).
  • the injection assembly (150) including the needle is positioned in the central region so that the patch-type drug injection device (100) can remain connected to the user without the insertion tube coming off even when the insertion tube is shaken due to the user's movement.
  • the drug storage unit (120) stores drugs and varies in thickness depending on the amount of drugs stored.
  • the drug storage unit (120) can be formed as a flat pouch bag made of polymer material, and is formed thinly using a flexible material, thereby enabling the patch-type drug injection device (100) to be implemented thinner and lighter.
  • FIG. 9 is a block diagram schematically showing the configuration of the pump assembly illustrated in FIG. 8.
  • the pump assembly (130) draws in a drug from the drug storage unit (120) and delivers the drug to the injection assembly (150).
  • the pump assembly (130) includes an electroosmotic pump (131) and a port connector (132).
  • the electroosmotic pump (131) is an electrochemically driven pump, and is electrochemically driven by a control signal to generate positive and negative pressures, draw in a drug from the drug storage unit (120), store it in the transfer chamber unit (134), and discharge the drug stored in the transfer chamber unit (134) to the injection assembly (150).
  • the electroosmotic pump (131) includes a driving unit (133) and a transfer chamber unit (134).
  • the driving unit (133) is electrochemically driven by a control signal to generate positive and negative pressures, thereby drawing in a drug from the drug storage unit (120), storing it in the transfer chamber unit (134), and discharging the drug stored in the transfer chamber unit (134) to the injection assembly (150).
  • the transfer chamber unit (134) receives the drug drawn from the drug storage unit (120) according to the pressure of the driving unit (133).
  • the drug is a drug that must be injected into a specific patient, and an example of this is insulin that is injected into a diabetic patient.
  • Fig. 10 is a block diagram schematically showing the configuration of the driving unit illustrated in Fig. 9, and Fig. 11 is an exemplary diagram schematically showing the operation of the driving unit illustrated in Fig. 9.
  • the driving unit (133) is a pump that uses the movement of fluid by the electroosmotic phenomenon that occurs when voltage or current is applied using electrodes at both ends of the pumping unit (membrane, 133a).
  • the driving unit (133) includes a membrane (133a) and a first electrode (133b) and a second electrode (133c) arranged on both sides of the membrane (133a), and when voltage or current is applied to the first electrode (133b) and the second electrode (133c) through a power source (133d), the fluid moves and the electroosmotic phenomenon occurs.
  • the driving unit (133) may include a first diaphragm (133e) and a second diaphragm (133f).
  • Each diaphragm (133e, 133f) is provided on one side and the other side of the pumping unit (133a) and changes shape by the movement of the pumping solution as positive and negative pressures are alternately generated.
  • the first diaphragm (133e) and the second diaphragm (133f) transfer the negative and positive pressures generated by the driving of the pumping unit (133a) to the drug.
  • the first diaphragm (133e) and the second diaphragm (133f) moves backward (when moving in the direction 1), and the fluid to be transported is sucked into the transport chamber portion (134).
  • positive pressure at least a portion of the first diaphragm (133e) and the second diaphragm (133f) moves forward (when moving in the direction 2), and the drug is discharged from the transport chamber portion (134).
  • the membrane (133a) is generally made of silica, glass, etc., and when immersed in an aqueous solution, the surface thereof becomes negatively charged.
  • the membrane (133a) has numerous paths through which fluids can pass, and when one of these is enlarged, the surface of the fluid passage with a negative charge (bound anion) can be in a state where the charge is balanced by cations with a movable (+) charge.
  • a (+) voltage is applied to the first electrode (133b) and a (-) voltage is applied to the second electrode (133c)
  • a negative pressure is generated, and the fluid inside the driving unit (133) moves in the 1 direction due to this negative pressure.
  • the drug flows into the transport chamber unit (134) through the suction valve (135) of the port connector (132).
  • the discharge valve (136) is closed.
  • a pump utilizing this principle is an electroosmotic pump (131).
  • the driving means can be manufactured thinner than other technologies using electric motors, etc. Accordingly, the overall thickness of the patch-type drug injection device (100) can be manufactured thinner, allowing for more stable bonding to the skin.
  • the port connector (132) connects the drug storage unit (120) and the injection assembly (150) to the electroosmotic pump (131).
  • the port connector (132) includes an inlet check valve (135) that allows the drug to flow into the transfer chamber unit (134) and a discharge check valve (136) that discharges the drug discharged from the transfer chamber unit (134) to the injection assembly (150).
  • the inlet check valve (135) and the discharge check valve (136) are arranged parallel to each other.
  • the port connector (132) is formed with an inlet path (132a) through which the drug flows from the drug storage unit (120) into the electroosmotic pump (131) and a discharge path (132b) through which the drug is discharged from the electroosmotic pump (131) to the injection assembly (150).
  • the circuit unit (140) is equipped with electronic components necessary for driving and controlling the pump assembly (130) and may include a battery for supplying power.
  • Fig. 12 is a perspective view of the injection assembly illustrated in Fig. 8.
  • the injection assembly (150) includes a needle (151) and a needle mover (152), and can inject a drug discharged from a pump assembly (130) into a subject to be injected.
  • One side (151a) of the needle (151) is coupled to a discharge path (132b) of a port connector (132), and the other side (151b) is inserted into the subject to be injected.
  • the needle (151) is formed in a shape extending from the discharge path (132b) toward the needle outlet (112a) of the contact surface (112).
  • the needle mover (152) is fixed by inserting a part of the needle (151), and moves by an external force to insert the needle (151) into the subject to be injected.
  • a shooting hole (111a) is formed in a region corresponding to the region where the injection assembly (150) is placed in the cover portion (111) of the housing (110).
  • the shooting hole (111a) is a hole (111a) into which a shooting member of an applicator (not shown) that presses a needle mover (152) so that the needle (151) can be inserted into the injection target is inserted.
  • the force with which the shooting member presses the needle mover (152) causes the other side (151b) of the needle (151) and the needle mover (152) to move toward the needle outlet (112a), so that a part of the other side (151b) of the needle (151) is inserted into the injection target.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Un dispositif d'injection de médicament de type patch selon un mode de réalisation de la présente invention comprend : un boîtier comprenant une partie couvercle et une surface de contact ; une sortie d'aiguille formée dans une zone de la surface de contact ; un bouton d'alimentation disposé adjacent à la sortie d'aiguille sur la surface de contact ; un orifice d'injection de médicament formé adjacent à la sortie d'aiguille sur la surface de contact ; et un capuchon de protection d'aiguille formé pour avoir une zone prédéterminée, couplé à la sortie d'aiguille, et séparable sélectivement de la sortie d'aiguille, le capuchon de protection d'aiguille étant formé pour recouvrir la sortie d'aiguille et le bouton d'alimentation lorsqu'il est couplé à la sortie d'aiguille.
PCT/KR2025/005230 2024-04-19 2025-04-17 Dispositif d'injection de médicament Pending WO2025221053A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR20240052441 2024-04-19
KR10-2024-0052441 2024-04-19
KR1020250033130A KR20250154231A (ko) 2024-04-19 2025-03-14 약물 주입 장치
KR10-2025-0033130 2025-03-14

Publications (1)

Publication Number Publication Date
WO2025221053A1 true WO2025221053A1 (fr) 2025-10-23

Family

ID=97403981

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2025/005230 Pending WO2025221053A1 (fr) 2024-04-19 2025-04-17 Dispositif d'injection de médicament

Country Status (1)

Country Link
WO (1) WO2025221053A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040116866A1 (en) * 2002-12-17 2004-06-17 William Gorman Skin attachment apparatus and method for patient infusion device
KR20180028232A (ko) * 2016-09-08 2018-03-16 중소기업은행 약액 주입장치
JP7083913B2 (ja) * 2018-03-15 2022-06-13 イプスメッド・アクチェンゲゼルシャフト 改善されたハウジングと、リリースライナーを使用して無菌バリアフィルムを除去するためのリリースライナーとを含む注射または注入デバイス
US20230038182A1 (en) * 2021-06-24 2023-02-09 Becton, Dickinson And Company User removable fill closure tab with integrated membrane
KR102619176B1 (ko) * 2021-11-04 2023-12-29 이오플로우(주) 약액 주입 장치

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040116866A1 (en) * 2002-12-17 2004-06-17 William Gorman Skin attachment apparatus and method for patient infusion device
KR20180028232A (ko) * 2016-09-08 2018-03-16 중소기업은행 약액 주입장치
JP7083913B2 (ja) * 2018-03-15 2022-06-13 イプスメッド・アクチェンゲゼルシャフト 改善されたハウジングと、リリースライナーを使用して無菌バリアフィルムを除去するためのリリースライナーとを含む注射または注入デバイス
US20230038182A1 (en) * 2021-06-24 2023-02-09 Becton, Dickinson And Company User removable fill closure tab with integrated membrane
KR102619176B1 (ko) * 2021-11-04 2023-12-29 이오플로우(주) 약액 주입 장치

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