WO2020070608A1 - Reset connector for an injection device and an injection device trainer - Google Patents

Reset connector for an injection device and an injection device trainer

Info

Publication number
WO2020070608A1
WO2020070608A1 PCT/IB2019/058251 IB2019058251W WO2020070608A1 WO 2020070608 A1 WO2020070608 A1 WO 2020070608A1 IB 2019058251 W IB2019058251 W IB 2019058251W WO 2020070608 A1 WO2020070608 A1 WO 2020070608A1
Authority
WO
WIPO (PCT)
Prior art keywords
actuator
shield
injection device
distal
proximal
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.)
Ceased
Application number
PCT/IB2019/058251
Other languages
English (en)
French (fr)
Inventor
Hung Mach
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.)
Janssen Pharmaceuticals Inc
Original Assignee
Janssen Pharmaceuticals Inc
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 to BR112021005975-0A priority Critical patent/BR112021005975A2/pt
Priority to EP19780434.7A priority patent/EP3860695A1/en
Priority to CA3114128A priority patent/CA3114128A1/en
Priority to JP2021542297A priority patent/JP7576554B2/ja
Priority to MX2021003868A priority patent/MX2021003868A/es
Priority to AU2019351943A priority patent/AU2019351943B2/en
Application filed by Janssen Pharmaceuticals Inc filed Critical Janssen Pharmaceuticals Inc
Priority to KR1020217012989A priority patent/KR20210070337A/ko
Priority to CN201980079542.3A priority patent/CN113164693B/zh
Publication of WO2020070608A1 publication Critical patent/WO2020070608A1/en
Priority to IL281928A priority patent/IL281928A/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61M5/178—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
    • A61M5/3157—Means providing feedback signals when administration is completed
    • 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
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A61M5/31586—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by rotationally moving or pivoted actuator, e.g. an injection lever or handle
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3257—Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
    • A61M5/502—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/285—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B9/00—Simulators for teaching or training purposes
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3143—Damping means for syringe components executing relative movements, e.g. retarders or attenuators slowing down or timing syringe 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3254—Shielding of proximal needles, e.g. for pen needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
    • A61M5/502—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston
    • A61M2005/5033—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston by use of an intermediate blocking member positioned between the syringe barrel and the piston rod to prevent retraction of the latter, e.g. toothed clip placed on the piston rod
    • 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
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • 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
    • 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
    • A61M5/31571—Means preventing accidental administration
    • 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

Definitions

  • This disclosure relates to an injection device for administering an injection and an injection device trainer for training a user to use an injection device.
  • a conventional syringe for administering injections includes a barrel for holding medicament, a plunger that fits within the barrel and a needle through which the medicament is expelled when the plunger is pushed inside the barrel.
  • the syringe will have a cap for shielding the needle when the syringe is not being used to administer an injection, which can be removed in order to expose the needle.
  • a specific problem with a conventional syringe is that a patient might accidentally stick themselves, or someone else, with the needle before administering the injection. Another specific problem is that it can be difficult to align the needle with the target site correctly, and thus an injection might be administered in the wrong place. Therefore, conventional syringes can be complicated and potentially unsafe to use, particularly for patients with limited dexterity.
  • Injection devices exist that have been designed to overcome these issues with conventional syringes.
  • One such device includes a needle shield and a plunger which can be actuated in order to force medicament from the needle and into the patient.
  • the needle shield retracts when pressed against the target site in order to expose the needle, and the plunger can be pressed at the same time for administering the injection.
  • This allows the injection to be administered in a single motion by pressing the plunger of the device down onto the target site.
  • This allows a patient to administer themselves with an injection in a safe and simple manner.
  • these devices are designed so that they can be used only once, for instance by locking the needle shield in a position that covers the needle once the injection is complete. This prevents a patient from using a needle more than once, which has hygiene and health benefits.
  • an injection device trainer for training a user to use an injection device, the injection device trainer comprising a body portion, an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position, a shield positioned towards a distal end of the body portion, the shield moveable between: an initial position; a retracted position that is more proximal relative to the body portion than the initial position; and an extended position that is more distal relative to the body portion than the initial position, and a locking member rotatable between a first orientation in which the locking member resists movement of the actuator from the proximal position to the distal position; and a second orientation in which the locking member permits the actuator to move from the proximal position to the distal position.
  • the first orientation of the locking member is configured to hold the shield in the initial position such that the shield is prevented from moving from the initial position to the extended position, and permits movement of the shield from the initial position to the retracted position.
  • the shield is configured to contact with the locking member when moving from the initial position to the retracted position in order to move the locking member from the first orientation to the second orientation. Movement of the actuator by a first distance towards the distal position unlocks the shield from the locking member such that the shield is allowed to move towards the extended position.
  • the injection device trainer accurately simulates use of an injection device which improves the training process.
  • the user can practice administering an injection more times than in comparison to the situation in which training is only possible when a real injection is required.
  • the locking member provides a mechanism for simulating use of the injection device.
  • an injection device comprising, a needle coupled with a chamber for storing fluid, a body portion, an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle, a shield positioned towards a distal end of the body portion, the shield moveable between: an initial position in which the shield covers the needle; a retracted position in which the shield exposes the needle, wherein the retracted position is more proximal relative to the body portion than the initial position; and an extended position in which the shield covers the needle, wherein the extended position is more distal relative to the body portion than the initial position, and a locking member rotatable between a first orientation in which the locking member resists movement of the actuator from the proximal position to the distal position; and a second orientation in which the locking member permits the actuator to move from the proximal position to the distal position.
  • the first orientation of the locking member is configured to hold the shield in the initial position such that the shield is prevented from moving from the initial position to the extended position, and permits movement of the shield from the initial position to the retracted position.
  • the shield is configured to contact the locking member when moving from the initial position to the retracted position in order to move the locking member from the first orientation to the second orientation. Movement of the actuator by a first distance towards the distal position unlocks the shield from the locking member such that the shield is allowed to move towards the extended position.
  • an injection device trainer comprising, a body portion, an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position, a shield positioned towards a distal end of the body portion, the shield moveable between: an initial position; a retracted position that is more proximal relative to the body portion than the initial position; and an extended position that is more distal relative to the body portion than the initial position, and a locking member rotatable between a first orientation in which the locking member resists movement of the actuator from the proximal position to the distal position; and a second orientation in which the locking member permits the actuator to move from the proximal position to the distal position.
  • the first orientation of the locking member is configured to hold the shield in the initial position such that the shield is prevented from moving from the initial position to the extended position, and permits movement of the shield from the initial position to the retracted position.
  • the method further comprises moving the shield from the initial position to the retracted position so that the shield contacts with the locking member in order to move the locking member from the first orientation to the second orientation, and moving the actuator by a first distance towards the distal position to unlock the shield from the locking member such that the shield moves towards the extended position.
  • a method of administering an injection comprising providing an injection device comprising, a needle coupled with a chamber for storing fluid, a body portion, an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle, a shield positioned towards a distal end of the body portion, the shield moveable between: an initial position in which the shield covers the needle; a retracted position in which the shield exposes the needle, wherein the retracted position is more proximal relative to the body portion than the initial position; and an extended position in which the shield covers the needle, wherein the extended position is more distal relative to the body portion than the initial position, and a locking member rotatable between a first orientation in which the locking member resists movement of the actuator from the proximal position to the distal position; and a second orientation in which the locking member permits the actuator to move from
  • the first orientation of the locking member is configured to hold the shield in the initial position such that the shield is prevented from moving from the initial position to the extended position, and permits movement of the shield from the initial position to the retracted position.
  • the method further comprises moving the shield from the initial position to the retracted position so that the shield contacts the locking member in order to move the locking member from the first orientation to the second orientation, and moving the actuator by a first distance towards the distal position to unlock the shield from the locking member such that the shield moves towards the extended position.
  • an injection device trainer for training a userto use an injection device, the injection device trainer comprising, a body portion and an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position.
  • the body portion comprises a body protrusion and the actuator comprises a latch that is arranged to couple with the body protrusion when the actuator is in the distal position, thus holding the actuator in the distal position.
  • an injection device comprising a needle coupled with a chamber for storing fluid, a body portion, and an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle.
  • the body portion comprises a body protrusion and the actuator comprises a latch that is arranged to couple with the body protrusion when the actuator is in the distal position, thus holding the actuator in the distal position.
  • an injection device trainer for training a user to use an injection device, the injection device trainer comprising a body portion and an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position.
  • the body portion comprises a body protrusion and the actuator comprises a latch that is arranged to contact the body protrusion when the actuator is in the distal position and to emit an audible sound.
  • the audible sound indicates that the actuator has reached the distal position which simulates completion of an injection being administering by an injection device. Therefore, the user can be trained to determine that an injection has been administered properly.
  • the audible sound may have an intensity that enables a user to hear the sound at 1 m away from the device, or at least at an arm’s length from the device.
  • the latch may be configured to emit an audible sound above a predetermined threshold intensity at a certain distance from the device (e.g. 30cm).
  • the predetermined threshold intensity may be 40 dB, such that the intensity of the sound emitted is above the normal sound intensity of a quiet room. This enables the user to hear the sound in a normal working environment.
  • the predetermined threshold intensity may be 50 dB, 60 dB or even 70 dB in order to ensure that the user can hear the sound in a variety of different environments.
  • the sound may be in the form of a‘click’, which is a short sound (e.g. less than a second long). The sound is emitted due to the mechanical interaction between the latch and the body protrusion, and is not emitted by an electronic device.
  • an injection device comprising a needle coupled with a chamber for storing fluid, a body portion, and an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position for dispensing the fluid stored in the chamber from the needle.
  • the body portion comprises a body protrusion and the actuator comprises a latch that is arranged to contact the body protrusion when the actuator is in the distal position and to emit an audible sound.
  • the audible sound indicates that the actuator has reached the distal position which indicates completion of an injection being administering by the injection device. Therefore, the user can more accurately determine that the injection has been administered properly.
  • a method for training a user to use an injection device comprising providing an injection device trainer comprising a body portion and an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position.
  • the body portion comprises a body protrusion and the actuator comprises a latch.
  • the method further comprises moving the actuator from the proximal position to the distal position so that the latch couples with the body protrusion when the actuator is in the distal position, thus holding the actuator in the distal position.
  • a method of administering an injection comprising providing an injection device comprising a needle coupled with a chamber for storing fluid, a body portion, and an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle.
  • the body portion comprises a body protrusion and the actuator comprises a latch.
  • the method further comprises moving the actuator from the proximal position to the distal position so that the latch couples with the body protrusion when the actuator is in the distal position, thus holding the actuator in the distal position.
  • a method for training a user to use an injection device comprising providing an injection device trainer comprising a body portion and an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position.
  • the body portion comprises a body protrusion and the actuator comprises a latch.
  • the method further comprises moving the actuator from the proximal position to the distal position so that the latch contacts the body protrusion when the actuator is in the distal position and emits an audible sound.
  • a method of administering an injection comprising providing an injection device comprising a needle coupled with a chamber for storing fluid, a body portion, and an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position for dispensing the fluid stored in the chamber from the needle.
  • the body portion comprises a body protrusion and the actuator comprises a latch.
  • the method further comprises moving the actuator from the proximal position to the distal position so that the latch contacts the body protrusion when the actuator is in the distal position and emits an audible sound.
  • an injection device trainer for training a user to use an injection device, the injection device trainer comprising a body portion, an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position, a shield positioned towards a distal end of the body portion, the shield moveable between: an initial position; an extended position that is more distal relative to the body portion than the initial position, and a connector that connects the actuator to the shield such that movement of the actuator from the distal position towards the proximal position pulls the shield from the extended position to the initial position.
  • an injection device comprising a needle coupled with a chamber for storing fluid, a body portion, an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle, a shield positioned towards a distal end of the body portion, the shield moveable between: an initial position in which the shield covers the needle; a retracted position in which the shield exposes the needle, wherein the retracted position is more proximal relative to the body portion than the initial position; and an extended position in which the shield covers the needle wherein the extended position is more distal relative to the body portion than the initial position, and a connector that connects the actuator to the shield such that movement of the actuator from the distal position towards the proximal position pulls the shield from the extended position to the initial position.
  • a method of administering an injection comprising providing an injection device comprising a needle coupled with a chamber for storing fluid, a body portion, an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle, a shield positioned towards a distal end of the body portion, the shield moveable between: an initial position in which the shield covers the needle; a retracted position in which the shield exposes the needle, wherein the retracted position is more proximal relative to the body portion than the initial position; and an extended position in which the shield covers the needle wherein the extended position is more distal relative to the body portion than the initial position, and a connector that connects the actuator to the shield.
  • the method further comprises moving the actuator from the distal position towards the proximal position in order to pull the shield from the extended position to the initial position using the connector.
  • an injection device trainer for training a user to use an injection device, the injection device trainer comprising a body portion an actuator assembly positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position, wherein the actuator assembly is coupled with a rotor, such that movement of actuator from the proximal position to the distal position causes the rotor to rotate, and a damping element coupled, or coupleable, to the rotor in order to damp the rotation of the rotor.
  • an injection device comprising a needle coupled with a chamber for storing fluid a body portion, an actuator assembly positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position for dispensing the fluid stored in the chamber from the needle, wherein the actuator assembly is coupled with a rotor, such that movement of the actuator from proximal position to the distal position causes the rotor to rotate, and a damping element coupled, or coupleable, to the rotor in order to damp the rotation of the rotor.
  • a method for training a user to use an injection device comprising providing an injection device trainer comprising a body portion, an actuator assembly positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position, wherein the actuator assembly is coupled with a rotor, such that movement of actuator from the proximal position to the distal position causes the rotorto rotate, and a damping element coupled, or coupleable, to the rotor in order to damp the rotation of the rotor.
  • the method further comprises moving the actuator from the proximal position to the distal position during which the damping element damps rotation of the rotor and thus damps movement of the actuator towards the distal position.
  • a method of administering an injection comprising providing an injection device comprising a needle coupled with a chamber for storing fluid, a body portion, an actuator assembly positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position for dispensing the fluid stored in the chamber from the needle, wherein the actuator assembly is coupled with a rotor, such that movement of the actuator from proximal position to the distal position causes the rotorto rotate, and a damping element coupled, or coupleable, to the rotor in order to damp the rotation of the rotor.
  • the method further comprises moving the actuator from the proximal position to the distal position during which the damping element damps rotation of the rotor and thus damps movement of the actuator towards the distal position.
  • the locking member may comprise an actuator resistance surface that is arranged to resist movement of the actuator from the proximal position to the distal position, when the locking member is in the first orientation.
  • the actuator resistance surface may comprise a protrusion extending from the locking member.
  • the actuator may comprise an abutment surface that is arranged to abut the actuator resistance surface when the actuator is in the proximal position and the locking member is in the first orientation.
  • the abutment surface may comprise a protrusion extending from the actuator.
  • the locking member may comprise at least two (or a pair of) actuator resistance surfaces.
  • the pair of actuator resistance surfaces may be located on opposite sides of the locking member with respect to one another.
  • the actuator may comprise at least two (or a pair of) abutment surfaces.
  • the pair of abutment surfaces may be located on opposite sides of the actuator with respect to one another.
  • the locking member may comprise a cylindrical housing, and the actuator resistance surface may comprise a protrusion that protrudes from the surface of the cylindrical housing.
  • the protrusion may span only partially around the circumference of the cylindrical housing.
  • the locking member may comprise a ramp.
  • the shield may comprise a ramp interface. The ramp interface of the shield may be arranged to interact with the ramp of the locking member when moving from the initial position to the retracted position in order to rotate the locking member from the first orientation to the second orientation. This provides a simple and reliable mechanism for rotating the locking member into the second orientation.
  • the locking member may comprise a third orientation in which the shield is allowed to move from the initial position to the extended position.
  • the actuator may be configured to move by a first distance in order to move the locking member into the third orientation. In this way, the shield is prevented from moving to the extended position until the actuator has been at least partially depressed.
  • the extended position simulates a locked-out state of an injection device, indicating that injection has been completed. Therefore, the trainer cannot simulate completion of the injection procedure until the actuator has been activated by the user.
  • the locking member may comprise a stop that is arranged to sit within a recess in the shield, thus holding the shield in the initial position. This provides a simple and reliable mechanism for keeping the shield in the initial position.
  • the stop may be arranged to move along a slot in the shield in order to allow the shield to move to the extended position.
  • the stop may sit outside of the slot in the recess thus holding the shield in the initial position when the locking member is in the first orientation. In this way, the stop can be used to allow the shield to move from the initial position to the extended position by moving the stop from the recess into the slot.
  • the stop may be coupled to a resilient member that is configured to bend in order to move the stop inwards from a resting state towards the longitudinal axis of the trainer into a flexed state.
  • the stop in the resting state holds the shield in the initial position.
  • the stop in the flexed state permits the stop to move into the slot. This provides a reliable mechanism for allowing the shield to move from the initial position to the extended position.
  • the trainer may comprise a biasing element that biases the shield to move distally.
  • the shield can move automatically from the retracted position to either the initial position or the extended position, depending on the orientation of the locking member.
  • the actuator resistance surface of the locking member may comprise a deflector portion.
  • the actuator may be arranged to interface with the deflector portion to move the locking member from the second orientation to the third orientation. Therefore, the actuator pushes down on the deflector portion in order to move the locking member into the orientation that permits the shield to move to the extended position.
  • the trainer may comprise a biasing element arranged to bias the locking member in a first rotational direction.
  • the biasing element may comprise a torsion spring.
  • the biasing element may bias the locking member to rotate away from the second orientation or the third orientation towards the first orientation. Therefore, it is possible to automatically reset the trainer.
  • the biasing element may bias the locking member towards a fourth orientation such that once the actuator has moved a distance towards the distal position and the shield is in the extended position the locking member moves into the fourth orientation.
  • the locking member in the fourth orientation may prevent the shield from moving from the extended position to the initial position. Therefore, the shield can automatically be positioned in a locked- out state, once the actuator has been depressed.
  • the actuator may be configured to interfere with the locking member when moving from the distal position to the proximal position to move the locking member towards the first orientation thus allowing the shield to move from the extended position to the initial position. This allows the user to reset the trainer by moving the actuator back to the proximal position from the distal position.
  • the locking member may comprise a shield resistance surface that is arranged to resist proximal movement of the shield when the locking member is in the fourth orientation and the shield is in the extended position.
  • the shield may comprise an abutment surface that abuts the shield resistance surface when the locking member is in the fourth orientation and the shield is in the extended position. This assists in maintaining the shield in the locked-out state.
  • the proximal position of the actuator simulates an unactivated position of a plunger of an injection device.
  • the distal position ofthe actuator simulates an activated position of a plunger of an injection device.
  • the initial position of the shield simulates covering of a needle of an injection device.
  • the retracted position of the shield simulates exposing a needle of an injection device.
  • the extended position of the shield simulates a locked-out state of an injection device in which the shield is prevented from exposing a needle. Therefore, the trainer can accurately simulate the operation of an injection device.
  • the latch may be configured such that an audible sound is emitted when the latch couples with the body protrusion, thus indicating that the actuator is in the distal position.
  • the audible sound indicates that the actuator has reached the distal position which simulates completion of an injection being administering by an injection device so that the user can more accurately determine that an injection has been administered properly when using the injection device.
  • the latch may be configured to hold the actuator in the distal position when the latch is coupled with the body protrusion. Coupling of the latch to the body protrusion indicates that the actuator has reached the distal position which simulates completion of an injection being administering by an injection device so that the user can more accurately determine that an injection has been administered properly when using the injection device.
  • the latch may comprise a resilient member.
  • the latch may be moveable between an uncoupled state in which the latch is not coupled with the body protrusion and a coupled state in which the latch is coupled with the body protrusion. Therefore, the latch simply can be bent into coupling with the body portion.
  • the resilient member may be arranged to move from the coupled state to the uncoupled state when a force above a threshold is applied to the actuator in moving the actuator from the distal position to the proximal position. Therefore, the latch can hold the actuator in the distal position securely, while allowing the trainer to return to its initial configuration when a user purposefully applies a force above the threshold to the actuator.
  • the latch may comprise a latch deflector portion that is arranged to interface with the body protrusion in order to move the latch from the uncoupled state into the coupled state.
  • the latch may comprise a gripping element that grips the body portion in the coupled state. In this way, the deflector portion assists in moving the latch into coupling with the body, and the gripping element assists in maintain the latch and body in connection with one another.
  • the resilient member may comprise the deflector portion and/or the gripping element.
  • the deflector portion and the gripping element may be provided on opposite sides of the latch. This provides a reliable construction for the latch.
  • the connector may resist the shield from moving distally away from the initial position when the actuator is in the proximal position. In this way, the connector assists in maintaining the shield in the initial position.
  • the connector may allow the shield to move towards the retracted position when the actuator is in the proximal position. In this way, the connector does not impede retraction of the shield to the retracted position.
  • the connector may allow the shield to move distally towards the extended position when the actuator moves towards the distal position. Thus, the connector can act to release the shield.
  • the connector may have an actuator interface that abuts a portion of the actuator to resist the shield from moving distally away from the initial position when the actuator is in the proximal position. The abutment of the actuator interface and the actuator provides a mechanism for holding the shield in the initial position.
  • the actuator interface may abut a surface of the actuator that faces the proximal direction.
  • the connector can be moved by the actuator when the actuator moves proximally, but the actuator does not move the connector when it moves distally.
  • the connector may have a shield interface that abuts a portion of the shield to resist the shield from moving distally away from the initial position when the actuator is in the proximal position. This provides a mechanism for holding the shield in the initial position.
  • the shield interface may abut a surface of the shield that faces the distal direction.
  • the connector can move the shield when the actuator moves proximally, but the connector does not move the shield when it moves distally.
  • kit of parts configured for assembly into an injection device trainer or an injection device as described herein.
  • Figure 1 illustrates an injection device trainer for training a user to use an injection device
  • Figure 2A illustrates a cap attached to a distal end of the injection device trainer
  • Figure 2B illustrates the injection device trainer with an actuator in a proximal position and a shield in an initial position
  • Figure 2C illustrates the actuator in the proximal position and the shield in a retracted position
  • Figure 2D illustrates the actuator moved distally from the proximal position and the shield in the retracted position
  • Figure 2E illustrates the actuator in a distal position and the shield in the retracted position
  • Figure 3A illustrates the actuator in the distal position and the shield in an extended position
  • Figure 3B illustrates the actuator as it moves proximally towards distal position and the shield in an extended position
  • Figure 3C illustrates the actuator in the distal position and the shield in the initial position
  • Figure 4 illustrates an exploded view of the injection device trainer
  • Figure 5A illustrates a side view of internal components of the injection device trainer with the actuator in the proximal position and the shield in the initial position;
  • Figure 5B illustrates a perspective view of internal components of the injection device trainer with the actuator in the proximal position and the shield in the initial position;
  • Figure 6 illustrates an exploded view of an inner shield portion and a locking member
  • Figure 7A illustrates a side view of internal components of the injection device trainer with the actuator in the proximal position and the shield in the retracted position;
  • Figure 7B illustrates a perspective view of internal components of the injection device trainer with the actuator in the proximal position and the shield in the retracted position;
  • Figure 8 illustrates a perspective view of internal components of the injection device trainer with the actuator in the distal position and the shield in the extended position;
  • Figure 9 illustrates an exploded view of the injection device trainer with a connector
  • Figure 10 illustrates an exploded view of the injection device trainer with a latch
  • Figure 1 1 B illustrates a perspective view of internal components of the injection device trainer and damping element.
  • Figure 12A illustrates a perspective view of the rotor.
  • Figure 12B illustrates a top view of the rotor, in which the angled teeth can be seen.
  • Figure 12C illustrates a bottom view of the rotor.
  • Figure 13A illustrates a side view of the rotor.
  • Figure 13B illustrates a cutaway view taken along section A-A.
  • Figure 14A illustrates a second side view of the rotor.
  • Figure 14B illustrates a cutaway view taken along section B-B.
  • Figure 15 illustrates a side view of the rotor and damping element, when fully engaged.
  • an injection device trainer 1 for training a user to use an injection device.
  • the trainer 1 comprises a body portion 3 which has a proximal end 5 and a distal end 7.
  • the distal end 7 of the body portion 3 is positioned towards a surface of the user’s body, which may be a target site into which the user would normally administer an injection.
  • the proximal end 5 of the body portion 3 is positioned towards the user’s hand that is used to activate the trainer 1 .
  • the body portion 3 also has a window 12 in each side of the body portion 3 which simulates a window in an injection device that is used to view the medicament contained within the device.
  • proximal and“distal” are used herein to describe the device, these terms are used to provide context and do not require the trainer 1 to be used in any particular orientation.
  • the terms“first end” and“second end” could be used in place of the terms“distal end” and“proximal end” without changing the intended meaning.
  • the injection device trainer 1 also comprises an actuator 9 and a shield 1 1 .
  • the actuator 9 simulates the plunger in an injection device that is used to dispense medicament from a needle.
  • the shield 1 1 simulates the needle shield in an injection device that is used to cover and expose the needle.
  • the trainer 1 has a removable cap 13 that can be positioned over the shield 1 1 in order to prevent accidental retraction of the shield 1 1 .
  • the cap 13 comprises a pair of indents 15 on its inner surface. These indents 15 are arranged to be positioned over a pair of raised portions 17 on an outer surface of the distal end 7 of the body portion 3. This holds the cap 13 in place.
  • the distal end 7 of the body portion 3 also comprises a pair of nodes 19 on opposite sides of each indent 15 that abut with the surface of the shield 1 1 , so that the shield 1 1 is prevented from progressing further towards the proximal end 5 once the indents 15 have interfaced with the raised portions 17.
  • Figures 2A-E there is a sequence for training a user on administering an injection using the injection device trainer 1 .
  • Figure 2A represents the trainer 1 as described with reference to Figure 1 .
  • Figure 2B illustrates the trainer 1 with the cap 13 removed which exposes the shield 1 1 .
  • the shield 1 1 is in an initial position which simulates the position of a needle shield of an injection device in which the needle is covered.
  • the user can grip the trainer 1 by the actuator 9 and position the shield 1 1 over the target site. Then, the user can push the actuator 9 towards the distal end 7 of the body portion 3. This action causes the shield 1 1 to move in the direction of the proximal end 5 to a retracted position of the shield 1 1 .
  • the actuator 9 is prevented from moving towards the distal end 7 relative to the body portion 3, when the shield 1 1 is in the initial position. Therefore, the actuator 9 is held in a proximal position and cannot advance forward. However, once the shield 1 1 is in the retracted the position, the actuator 9 is allowed to move in the distal direction along the longitudinal axis of the trainer 1 .
  • Figure 2C illustrates the shield 1 1 in the retracted position which is a position more proximal relative to the body portion 3 than the initial position.
  • the shield 1 1 is partially retracted inside the body portion 3 when in the retracted position. This position simulates the position of a needle shield of an injection device in which the needle is exposed for administering an injection.
  • the actuator 9 is allowed to move distally once the shield 1 1 is in the retracted position.
  • Figure 2D illustrates the actuator 9 progressing towards the distal end 7.
  • Figure 2E illustrates the actuator 9 in a distal position which simulates the position of the plunger in an injection device once the injection has been administered.
  • Figures 3B-C the user can pull the actuator 9 towards the proximal end 5 in order to reset the trainer 1 so that the sequence described with reference to Figures 2A-E can be repeated.
  • Figure 3B illustrates the actuator 9 progressing towards the proximal position
  • Figure 3C illustrates the actuator 9 once it has reached the proximal position.
  • Figure 4 illustrates an exploded view on the injection device trainer 1 .
  • the body portion 3 comprises a base portion 21 that connects with a main portion 23 which is encased by a first outer portion 25 and a second outer portion 27.
  • the component parts of the body portion 3 fit together in orderto form a body assembly.
  • the body portion 3 could be formed of a single piece.
  • the shield 1 1 of the trainer 1 comprises an outer shield portion 29 and an inner shield portion 31 .
  • the outer shield portion 29 extends from the base portion 21 while the inner shield portion 31 sits within the body portion 3.
  • the plunger 41 is coupled with damping element 45 that is used to damp the rotation of the plunger 41 which, in turn, damps movement of the actuator 9 towards the distal position.
  • the trainer 1 further comprises a locking member 47 comprising a first locking portion 51 and a second locking portion 53.
  • the first and second locking portions 51 , 53 are separate components that connect together to form the locking member 47.
  • the locking member 47 is formed from a single piece.
  • the locking member 47 is rotatable about the longitudinal axis of the trainer 1 such that the locking member 47 can be placed in different rotational orientations.
  • the locking member 47 can rotate but cannot move proximally or distally with respect to the body portion 3.
  • the locking member 47 has a first orientation in which the locking member 47 resists movement of the actuator 9 from its proximal position (as shown in the Figures 2A-B) to the distal position (as shown in Figure 2E). Therefore, the first orientation of the locking member 47 is configured to hold the actuator 9 in the configuration described with reference to Figures 2A-B.
  • the trainer 1 also comprises a biasing element 55, which in this example is a torsion spring.
  • the biasing element 55 biases the locking member 47 in a first rotational direction 57.
  • the first rotation direction 57 may be clockwise or anticlockwise depending on the orientation of the trainer 1 .
  • the trainer 1 further comprises an inner housing 59 that simulates a syringe of an injection device, and a grip 61 that holds the inner housing in place.
  • Figures 5A-B illustrate the trainer 1 in the same configuration as described with reference to Figures 2A-2B with the actuator 9 in the proximal position and the shield 1 1 in the initial position.
  • the locking member 47 is in the first orientation which prevents the actuator 9 moving in the distal direction.
  • the locking member 47 comprises an actuator resistance surface 63 which comprises a protrusion that protrudes from a part of the outside surface of the cylindrical housing of the locking member 47.
  • the actuator resistance surface 63 protrudes from the locking member 47 in a direction away from the longitudinal axis of the trainer 1 .
  • the actuator 9 comprises an abutment surface 65 which comprises a protrusion that protrudes from a part of the inside surface of the actuator 9.
  • the abutment surface 65 protrudes from the actuator 9 in a direction towards the longitudinal axis of the trainer 1 .
  • the abutment surface 65 is arranged to abut against the actuator resistance surface 63. Therefore, the actuator resistance surface 63 is arranged to resist movement of the actuator 9 from the proximal position to the distal position when the locking member 47 is in the first orientation.
  • the trainer 1 there are two actuator resistance surfaces 63.
  • the actuator resistance surfaces 63 are positioned on opposite sides of the locking member 47 to one another. This allows the force of the actuator 9 being pressed down to be spread across the locking member 47.
  • the locking member 47 comprises a stop 67 that is arranged to sit within a recess 69 in the inner shield portion 31 of the shield 1 1 .
  • the stop 67 prevents the shield 1 1 from moving distally from the initial position to the extended position, but permits the shield 1 1 to move proximally towards the retracted position.
  • the locking member 47 comprises a pair of stops 67 positioned on opposite sides of the locking member 47 to one another.
  • the inner shield portion 31 comprises a pair of corresponding recesses 69 on opposite sides of the inner shield portion 31 to one another.
  • the recesses 69 define an aperture with similar, or the same, dimensions as the window 12 described with reference to Figure 1 .
  • FIGs 7A-B illustrate the trainer 1 in the same configuration as described with reference to Figures 2C with the actuator 9 in the proximal position and the shield 1 1 in the retracted position.
  • the locking member 47 has been rotated into the second orientation which permits the actuator 9 to move in the distal direction, as is described in more detail below.
  • the locking member 47 comprises a ramp 71 which in this example is an angled surface that extends from the outside surface of the second locking portion 53.
  • the inner shield portion 31 comprises a ramp interface 73 which in this example is an angled surface in a recess in the inner shield portion 31 .
  • the ramp 71 and the ramp interface 73 are shaped and positioned such that when the shield 1 1 is moved from the initial position to the retracted position the ramp interface 73 causes the locking member 47 to rotate.
  • the ramp 71 and ramp interface 73 cause the locking member 47 to rotate in a second rotational direction 75 which is the opposite rotational direction to the first rotational direction 57 towards which the locking member 47 is biased.
  • the locking member 47 comprises a pair of ramps 71 and the shield 1 1 comprises two ramp interfaces 73.
  • Each ramp 71 may be on an opposite side of the locking member 47 to the other.
  • Each ramp interface 73 may be on an opposite side of shield 1 1 to the other. This assists in reducing the frictional forces on the locking member 47 and the shield 1 1 .
  • the actuator resistance surface 63 of the locking member 47 comprises a deflector portion 79 that is configured to interface with the abutment surface 65 of the actuator when the actuator moves distally.
  • this causes the locking member 47 to move further in the second rotational direction 75 from the second orientation to a third orientation.
  • the abutment surface 65 moves to sit inside the gap 77 in the locking member 47. Therefore, the force of the actuator 9 moves the locking member 47 into the third orientation, which moves the stop 67 into a slot 81 in the inner surface of the inner shield portion 31 .
  • the slot 81 in the inner shield portion 31 forms a track within which the stop 67 can slide.
  • the slot 81 has an opening 83 at a proximal end of the inner shield portion 31 .
  • the slot 81 permits the shield 1 1 to move in the distal direction from the retracted position towards the extended position, and once the stop 67 reaches the opening 83 the inner shield portion 31 is released from contact with the locking member 47.
  • the shield 1 1 is allowed to move into the extended position when the stop 67 exits the opening 83 of the slot 81 . This permits the shield 1 1 to move past the locking member 47 to the extended position, which is more distal than the position of the locking member 47 and more distal than the initial position.
  • the location of the shield 1 1 relative to the locking member 47 when the shield 1 1 is in the extended position is shown in Figure 8, which is the configuration described with reference to Figure 3A.
  • the stop 67 comprises a resilient member 85 that is configured to be flexed inwards by the inner shield portion 31 .
  • the resilient member 85 and the stop 67 can move inwards towards the longitudinal axis of the trainer 1 .
  • the stop 67 is forced against an edge of the recess 69 when the actuator 9 forces the locking member 47 to rotate from the second orientation to the third orientation. This pushes the stop 67 and the resilient member 85 inwards, so that the stop 67 can enter the slot 81 in the inner shield portion 31 .
  • the stop 67 has an angled surface, which assists in flexing the resilient member 85 inwards.
  • the user can reset the trainer 1 by pulling the actuator 9 from the distal position back to the proximal position.
  • the actuator 9 moves in the proximal direction the abutment surface 65 interfaces with an angled surface of the reset deflector 87 in order to rotate the locking mechanism 47 from the fourth orientation into the first orientation.
  • the shield resistance surface 89 is no longer directly above the proximal end of the inner shield portion 31 in the direction of the longitudinal axis of the trainer 1 . Instead, the shield resistance surface 89 is directly above a recess in the inner shield portion 31 in the direction of the longitudinal axis of the trainer 1 . Therefore, the shield 1 1 is able to move towards the initial position from the extended position.
  • a reset connector 91 is provided that automatically pulls the shield 1 1 from the extended position into the initial position when the actuator 9 is pulled from the distal position into the proximal position.
  • the reset connector 91 is a rod of fixed length comprising an actuator interface, such as a first hook 93, at its proximal end.
  • the first hook 93 is arranged to interface with a portion of the actuator 9, such as a ledge 95 on the inner piece 39 of the actuator 9.
  • the ledge 95 faces in the proximal direction and therefore movement of the actuator in the proximal direction causes the reset connector 91 to move in the proximal direction when the ledge 95 contacts the first hook 93.
  • movement of the actuator 9 in the distal direction does not force the reset connector 91 to move in this direction, since no force can be applied by the actuator 9 on the first hook 93 in this direction.
  • the rest connector 91 also comprises a shield interface, such as a second hook 97 at its distal end.
  • the second hook 97 is arranged to abut with a portion of the shield 1 1 , for instance by being received by an aperture 92 in the shield 1 1 .
  • a proximal end 92a of the aperture 92 contacts the second hook 97. This permits the reset connector 91 to pull the shield 1 1 toward the initial position in order to reset the trainer 1 .
  • the aperture 92 may be configured, as illustrated by Figure 9, as an elongated aperture extending distally along the inner shield portion 31 .
  • the second hook 97 may be positioned within the aperture at all times during operation of the trainer 1 .
  • the second hook 97 tracks along the aperture 92 as the actuator 9 is moved distally from the proximal position, shown in Figure 2B, to the distal position, shown in Figure 2E, and moved proximally from the distal position towards the proximal position, until the second hook 97 contacts the proximal end 92a of the aperture, as described above, to permit the reset connector 91 to pull the shield 1 1 toward the initial position in order to reset the trainer 1 .
  • the aperture 92 may be formed in any suitable part of the shield 1 1 .
  • the aperture may be formed in the outer shield portion 29, and function in substantially the same manner as described above.
  • the aperture 92 may extend, in a direction perpendicular to the longitudinal axis of the trainer 1 , through the portion of the shield in which it is formed.
  • the aperture may be an etched portion, or indent, in the surface of the shield 1 1 .
  • the aperture 92 may have a closed distal end.
  • the aperture may be formed as a slot in the distal end of the inner and/or outer shield portion, having a closed, proximal end 92a against which the second hook 97 abuts, and an open distal end.
  • the aperture may not extend along the shield 1 1 so distally that the second hook 97 is positioned within the aperture at all times during operation of the trainer 1 .
  • the aperture 92 may be configured as an approximately circular aperture in the shield 1 1 .
  • the reset rod 91 may be configured such that the second hook 97 is resiliently biased into the aperture as the actuator is moved towards its proximal position, to permit contact between the second hook 97 and proximal end 92a of the aperture and, therefore, pulling of the shield 1 1 toward the initial position in order to reset the trainer 1 .
  • the second hook 97 may be shaped, at its distal end, to cam against a closed distal end of the aperture.
  • the injection device trainer 1 comprises a latch 99 that is configured to attach to the inner piece 39 of the actuator 9.
  • the latch 99 comprises a piece of resilient wire formed in a loop 101 that is arranged to be placed around a circular protrusion 103 on the inner piece 39. Since the latch 99 is resilient, the diameter of the loop 101 can be expanded to place it around the circular protrusion. Then, the loop can be released at which point the diameter of the loop 101 contracts so that the latch holds the circular protrusion 103.
  • the latch 99 also comprises a first extension 105 that is configured to be located between a pair of holders 107 that hold the latch 99 in place.
  • the latch 99 further comprises a second extension 109 that in this example is longer than the first extension 105.
  • the second extension 109 comprises a first portion 1 1 1 that extends in the distal direction and a second portion 1 13 that is angled with respect to the first portion 1 1 1 .
  • the second portion 1 13 forms a deflection portion on its distal side and gripping element on its proximal side. After the actuator 9 has moved a certain distance from the proximal position to the distal position, the second portion 1 13 comes into contact with a body protrusion 1 15 on the main portion 23 of the body portion 3.
  • the body protrusion 1 15 exerts force on the latch 99.
  • this force exceeds a threshold
  • the gripping element of the second portion 1 13 bends in a direction that is perpendicular to the direction that extends away from the longitudinal axis of the trainer 1 .
  • the gripping element passes by the body protrusion 1 15, so that the actuator 9 can be released from distal position.
  • the threshold force required to bend the latch ensures that the actuator 9 is held securely in the distal position.
  • the threshold force also permits the actuator 9 to snap back into the proximal position, once the gripping element releases the body protrusion.
  • the rotor 1 17 As the rotor 1 17 rotates, the rotor 1 17 uncoils the torsion spring 1 19 which damps rotation of the rotor 1 17 and thus damps progression of the actuator 9 towards the distal position.
  • the properties of the spring 1 19 may be selected according to the resistance desired. For example, if high resistance is desired, a spring 1 19 having a high spring constant may be selected.
  • the damping element 45 also comprises a ratchet 121 that comprises a plurality of angled teeth which interface with angled teeth 130 on the rotor 1 17.
  • a ratchet 121 that comprises a plurality of angled teeth which interface with angled teeth 130 on the rotor 1 17.
  • the damping element 45 and rotor 1 17 may be configured according to the point at which, during depression of the actuator, engagement of the rotor 1 17 and ratchet 121 , and therefore formation of the anti-rotation mechanism, is desired.
  • a spring 1 19 of high spring constant it may be desirable for the anti-rotation mechanism to engage earlier in depression of actuator 9, to assist a user in resisting the biasing of spring 1 19 back to its coiled state.
  • Earlier engagement of the anti-rotation mechanism earlier may be achieved, for example, by providing angled teeth of the ratchet 121 having a greater height along the longitudinal axis of the trainer 1 .
  • the plunger 41 moves the angled teeth of the rotor 1 17 out of engagement with the angled teeth of the ratchet 121 . This permits the rotor to move in the first rotational direction 57 when the plunger 41 moves proximally which moves the spring back to the coiled state.
  • the decoupling distance - the distance by which the actuator 9, plunger 41 , and rotor 1 17 are moved proximally in order to move the angled teeth of the rotor 1 17 out of engagement with the angled teeth of the ratchet 121 - is a distance greater than the height, along the longitudinal axis of the trainer 1 , of the angled teeth of the ratchet. In some embodiments, the decoupling distance may be approximately 2mm.
  • the damping element may be implemented in the trainer 1 in order to simulate a large volume and/or high viscosity dose.
  • the damping element may also be utilised in injection devices, to force a user to depress the actuator 9 slowly when delivering a large dose or a substance of low viscosity (which, itself, may offer little resistance to depression) to mitigate harmful side effects of injecting a substance too quickly, such as excessive bruising, pain, pooling of the injected substance within the patient, etc.
  • the torsion spring may be coupled to the ratchet.
  • the rotor interfaces with the thread of the plunger, and therefore the plunger causes the rotor to rotate in the second rotational direction as the plunger moves distally with the actuator.
  • the rotor is configured such that the straight edges of each tooth face in the second rotational direction. In other words, the straight edge of each angled tooth leads when the rotor is caused to rotate as the plunger moves distally with the actuator.
  • the initial rotation of the rotor in this embodiment does not cause uncoiling of the torsion spring. Hence, initial progression of the actuator towards the distal position is met by little, or no, resistance.
  • the alternative damping element comprises a ratchet coupled with the torsion spring that is biased towards a coiled state.
  • the ratchet comprises a plurality of angled teeth which interface with angled teeth on the rotor.
  • Rotation of the ratchet uncoils the torsion spring, which damps rotation of the ratchet and rotor and thus damps further progression of the actuator towards the distal position.
  • the configuration of the damping element and rotor for example the spring properties and teeth height, may be selected according to the desired resistance profile.
  • the rotor 1 17 and/or damping element 45 may be replaceable parts of a trainer or injection device.
  • the device may be configured such that torsion spring 1 19 may be replaced with another spring, of higher or lower spring constant. This facilitates, for example, a single trainer device to be used to train a user in delivering substances of various different viscosities.
  • An injection device in the context of this application may be an automatic injection device (an auto-injector).
  • the actuator 9 is operated by, or replaced by, an automated actuator such as a drive spring, a pneumatic piston operated by a compressed gas canister, or a solenoid, in an electrically powered automatic injection device.
  • the damping element 45 may be utilised to damp, slow or control the force applied by the actuator to a container which contains the substance to be injected and/or a delivery mechanism, e.g. a plunger on the drug container, such as a syringe.
  • the damping element may be useful in tuning the speed of an injection by an auto-injector, without requiring alteration of the automated actuator.
  • the damping element may be configured to operate during any portion of the actuation sequence.
  • the damping element may be configured such that progression of an actuator towards the distal position is damped for the entire duration of the progression, or for only a select portion.
  • the injection device may be configured such that damping of progression of the actuator begins at the point of full extension of a needle on the drug container, for example to ensure full delivery of the injection substance by an autoinjector.
  • references herein to“element” can additionally correspond to“means” for the element performing a particular function as stated herein.
  • An injection device trainer for training a user to use an injection device comprising:
  • an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position;
  • a shield positioned towards a distal end of the body portion, the shield moveable between: an initial position; an extended position that is more distal relative to the body portion than the initial position; and
  • a connector that connects the actuatorto the shield such that movement of the actuator from the distal position towards the proximal position pulls the shield from the extended position to the initial position.
  • the connector comprises an actuator interface that is configured to abut with a portion of the actuator to resist the shield from moving distally away from the initial position when the actuator is in the proximal position.
  • the connector comprises a shield interface arranged to abut with a portion of the shield to resist the shield from moving distally away from the initial position when the actuator is in the proximal position.
  • the actuator is coupled with a rotor, such that movement of actuator from the proximal position to the distal position causes the rotor to rotate;
  • the injection device trainer further comprises a damping element coupled or coupleable to the rotor in order to damp the rotation of the rotor.
  • a damping element coupled or coupleable to the rotor in order to damp the rotation of the rotor.
  • a needle coupled with a chamber for storing fluid
  • an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle;
  • a shield positioned towards a distal end of the body portion, the shield moveable between: an initial position in which the shield covers the needle; a retracted position in which the shield exposes the needle, wherein the retracted position is more proximal relative to the body portion than the initial position; and an extended position in which the shield covers the needle wherein the extended position is more distal relative to the body portion than the initial position; and
  • the actuator is coupled with a rotor, such that movement of actuator from the proximal position to the distal position causes the rotor to rotate;
  • the injection device further comprises a damping element coupled or coupleable to the rotor in order to damp the rotation of the rotor.
  • a kit of parts configured for assembly into an injection device trainer of any one of aspects 1 to 10 or an injection device of aspect 11 or aspect 12.
  • a method for training a user to use an injection device comprising providing an injection device trainer comprising:
  • an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position; a shield positioned towards a distal end of the body portion, the shield moveable between: an initial position; an extended position that is more distal relative to the body portion than the initial position; and
  • the method further comprises moving the actuator from the distal position towards the proximal position in order to pull the shield from the extended position to the initial position using the connector.
  • the actuator is coupled with a rotor, such that movement of actuator from the proximal position to the distal position causes the rotor to rotate;
  • the method further comprises moving the actuator from the proximal position to the distal position during which the damping element damps rotation of the rotor and thus damps movement of the actuator towards the distal position.
  • a method of administering an injection comprising providing an injection device comprising:
  • a needle coupled with a chamber for storing fluid
  • an actuator positioned towards a proximal end of the body portion, the actuator moveable from a proximal position to a distal position for dispensing fluid stored in the chamber from the needle;
  • a shield positioned towards a distal end of the body portion, the shield moveable between: an initial position in which the shield covers the needle; a retracted position in which the shield exposes the needle, wherein the retracted position is more proximal relative to the body portion than the initial position; and an extended position in which the shield covers the needle wherein the extended position is more distal relative to the body portion than the initial position; and
  • the actuator is coupled with a rotor, such that movement of actuator from the proximal position to the distal position causes the rotor to rotate;
  • the injection device further comprises a damping element coupleable to the rotor in order to damp the rotation of the rotor;
  • the method further comprises moving the actuator from the proximal position to the distal position during which the damping element damps rotation of the rotor and thus damps movement of the actuator towards the distal position.

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PCT/IB2019/058251 2018-10-01 2019-09-27 Reset connector for an injection device and an injection device trainer Ceased WO2020070608A1 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
EP19780434.7A EP3860695A1 (en) 2018-10-01 2019-09-27 Reset connector for an injection device and an injection device trainer
CA3114128A CA3114128A1 (en) 2018-10-01 2019-09-27 Reset connector for an injection device and an injection device trainer
JP2021542297A JP7576554B2 (ja) 2018-10-01 2019-09-27 注入装置及び注入装置訓練器具のためのリセットコネクタ
MX2021003868A MX2021003868A (es) 2018-10-01 2019-09-27 Conector de restablecimiento para un dispositivo de inyección y un dispositivo de entrenamiento de inyección.
AU2019351943A AU2019351943B2 (en) 2018-10-01 2019-09-27 Reset connector for an injection device and an injection device trainer
BR112021005975-0A BR112021005975A2 (pt) 2018-10-01 2019-09-27 conector de reinicialização para um dispositivo de injeção e um treinador para dispositivo de injeção
KR1020217012989A KR20210070337A (ko) 2018-10-01 2019-09-27 주사 장치 및 주사 장치 트레이너를 위한 리셋 커넥터
CN201980079542.3A CN113164693B (zh) 2018-10-01 2019-09-27 用于注射装置和注射装置训练器的重置连接器
IL281928A IL281928A (en) 2018-10-01 2021-03-31 Reset connector for injection device and trainer for injection device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1816034.1A GB2577693B (en) 2018-10-01 2018-10-01 Reset connector for an injection device and an injection device trainer
GB1816034.1 2018-10-01

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WO2020070608A1 true WO2020070608A1 (en) 2020-04-09

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EP (1) EP3860695A1 (https=)
JP (1) JP7576554B2 (https=)
KR (1) KR20210070337A (https=)
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KR20210070337A (ko) 2021-06-14
GB2577693A (en) 2020-04-08
GB2577693B (en) 2022-06-22
MX2021003868A (es) 2021-09-08
US11915608B2 (en) 2024-02-27
US20200101234A1 (en) 2020-04-02
BR112021005975A2 (pt) 2021-06-29
AU2019351943A1 (en) 2021-05-06
IL281928A (en) 2021-05-31
EP3860695A1 (en) 2021-08-11
AU2019351943B2 (en) 2025-03-13
TW202025109A (zh) 2020-07-01
CN113164693A (zh) 2021-07-23
CN113164693B (zh) 2023-05-26
JP7576554B2 (ja) 2024-10-31
JP2022508563A (ja) 2022-01-19
CA3114128A1 (en) 2020-04-09

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