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WO2025196054A1 - Dispositif d'injection pour délivrer une pluralité de doses fixes prédéfinies - Google Patents

Dispositif d'injection pour délivrer une pluralité de doses fixes prédéfinies

Info

Publication number
WO2025196054A1
WO2025196054A1 PCT/EP2025/057378 EP2025057378W WO2025196054A1 WO 2025196054 A1 WO2025196054 A1 WO 2025196054A1 EP 2025057378 W EP2025057378 W EP 2025057378W WO 2025196054 A1 WO2025196054 A1 WO 2025196054A1
Authority
WO
WIPO (PCT)
Prior art keywords
dose
injection device
selection button
dose selection
gear wheel
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/EP2025/057378
Other languages
English (en)
Inventor
Kim Frandsen
Ebbe Kiilerich
Antonios GIAKOS
Claus Urup GJØDESEN
Anders Hammelev MARSTRAND
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.)
Novo Nordisk AS
Original Assignee
Novo Nordisk AS
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
Application filed by Novo Nordisk AS filed Critical Novo Nordisk AS
Publication of WO2025196054A1 publication Critical patent/WO2025196054A1/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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31541—Means preventing setting of a dose beyond the amount remaining in the cartridge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/31556—Accuracy improving means
    • A61M5/31558—Accuracy improving means using scaling up or down transmissions, e.g. gearbox
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
    • A61M5/3158—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by axially moving actuator operated by user, e.g. an injection button
    • 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
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
    • A61M5/31595—Pre-defined multi-dose administration by repeated overcoming of means blocking the free advancing movement of piston rod, e.g. by tearing or de-blocking
    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2485—Ampoule holder connected to rest of syringe
    • A61M2005/2488—Ampoule holder connected to rest of syringe via rotation, e.g. threads or bayonet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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

Definitions

  • the invention relates to an injection device for ejecting a plurality of pre-defined fixed doses of a liquid drug from a drug container.
  • the invention preferably relates to the dose selection and dose ejection of the pre-defined fixed doses using a rotatable dose selection button and more preferably to the gearing mechanism of such injection device.
  • the drug container used is preferably an exchangeable medical cartridge thus making the injection device a reusable injection device.
  • the invention further relates to an End-of-Content mechanism for such injection device and to a cartridge change system for changing the exchangeable cartridge in such an injection device.
  • the piston rod is proximally provided with a gear wheel whereby the piston rod can be moved distally by translating a threaded element axially inside the injection device.
  • fixed dose injection devices inject one fixed dose whereafter the whole injection device is discarded.
  • Such injection devices are often referred to as single shot fixed dose injection devices as they only contain one single dose of the liquid drug to be delivered in one single shot.
  • fixed dose injection devices which are able to inject a plurality of predefined fixed doses has been developed.
  • Such injection devices are often referred to as multiuse fixed dose injection devices.
  • these injection devices are pre-filled by the manufacturer with the amount of drug needed for a specific number of injections and once the predetermined number of injections has been delivered the entire injection device is discarded.
  • WO 2020/089167 An example of such pre-filled multiuse fixed dose injection device for ejecting fixed doses of a liquid drug is disclosed in WO 2020/089167.
  • the user can expel a pre-defined fixed dose a predetermined number of times before the injection device is discarded.
  • the particular injection device disclosed is a torsion spring driven injection device wherein each of the fixed doses are automatically ejected by the use of a torsion spring which is strained by the user during selection of the fixed dose.
  • a manual pre-filled injection device suitable for expelling a predetermined number of pre-defined fixed doses is also disclosed in WO 2003/080160.
  • This injection device as disclosed in the embodiments on the figures 10 -19 has a dose selection button which is manually rotated out from the housing during dose selection and which rotates back into the housing during dose expelling.
  • the disclosed injection device further has a gearing mechanism to gear the axial distance the dose selection button is moved relatively to the axial distance the piston rod is moved.
  • the gearing mechanism is highly complicated and comprises a gear wheel having two different rolling diameters and two different toothed racks all rotationally mounted and engaging the gear wheel both during dose selection and during dose expelling.
  • a manually operational injection device with a gearing for manually injecting a plurality of pre-defined fixed doses which comprises a limited number of parts and which is simple in its structure and at the same time robust and reliable.
  • the present invention relates to an injection device for ejecting a number of pre-defined fixed doses of a liquid drug which comprises:
  • a housing structure configured for holding a loaded cartridge containing the liquid drug
  • a dose selection button which is functionally coupled to the housing structure for selecting a fixed dose
  • a piston rod assembly which is adapted to move a plunger inside the loaded cartridge and comprising a piston rod and a gear wheel, which gearwheel is rotatably coupled with the piston rod.
  • the fixed dose injection device further comprises a first toothed rack which is associated with the housing structure and a second toothed rack which is associated with the dose selection button and wherein, the gear wheel and the first toothed rack are engaged with each other both during dose selection and during dose ejection, and the gear wheel and the second toothed rack are disengaged during dose selection and engaged during dose ejection.
  • the gear wheel and the second toothed rack are disengaged during dose selection allowing the dose selection button to rotate helically out from the housing structure preferably independently of the piston rod assembly, to thereby select the pre-defined fixed dose and the gear wheel and the second toothed rack are engaged during dose ejection and the dose selection button is adapted to translate axially back into the housing structure to thereby eject the selected pre-defined fixed dose.
  • the gearing mechanism thus comprises two toothed racks and a gear wheel operationally connected to the piston rod.
  • the first toothed rack is permanently engaged with the gear wheel such that the gear wheel will always roll on the first toothed rack.
  • the first toothed rack is preferably operationally related to the housing structure e.g. via another element.
  • the second toothed rack and the gear wheel can however be brought into and out of engagement with each other.
  • the second toothed rack is preferably linked to the dose selection button.
  • first toothed rack being associated with the housing is preferably meant to imply that the first toothed rack is carried by a constructional element which is somehow linked to the housing structure
  • second toothed rack being associated with the dose selection button is preferably meant to imply that the second toothed rack is somehow linked to the injection button.
  • the dose selection button associated with the second toothed rack is rotated helically out from the housing structure, which decouples the second toothed rack from the gear wheel thereby allowing the dose selection button to be moved any distance out from the housing structure.
  • the pitch on the threaded engagement between the dose selection button and the housing structure are preferably different from the pitch of the threaded connection between the second tooted rack and the gear wheel.
  • the dose selection button is translated axially back into the housing structure without rotation.
  • the gear wheel is in contact with both the toothed racks and thus rolls on both toothed racks.
  • the rolling diameter of the gear wheel thus defines the gearing ratio which in the present example of the invention is set to 1:2 such that the piston rod travels half the translational distance of the distance the dose selection button travels in the second mode.
  • any gearing ratio can be used.
  • the herein described fixed dose device is thus suitable for ejecting a pre-determined number of pre-defined fixed doses from an exchangeable loaded cartridge.
  • the volume of these predefined fixed doses are preferably the same for all doses and determined by the manufacturer of the injection device such that the specific volume of the doses are inherent in the injection device and unchangeable for the user of the injection device.
  • the housing structure or the dose selection button is provided with one or more thread segments and the other of the dose selection button or the housing structure is provided with at least one helical track. Due to this helical interface between the dose selection button and the housing structure, the dose selection button is always rotated helically out from the housing structure when the user selects the pre-defined fixed dose to be injected.
  • the housing structure or the dose selection button are provided with one or more thread segments and the other is provided with at least one translational track. Due to this translational interface between the dose selection button and the housing structure, the dose selection button is always translated axially back into the housing structure when the user ejects the selected predefined fixed dose.
  • the dose selection button is thus able to move helically out from the housing structure during dose selection and to translate axially back into the housing during expelling of the selected pre-define fixed dose by being guided in the housing structure.
  • the clicker arrangement comprises a segment or protrusion having one or more lowered portions which lowered portions engages a raised knob provided in the dedicated position in the track configuration.
  • the segment or protrusion having lowered portions could in a further example be the thread segment carried by the housing structure and the raised knobs could be provided in specific positions along the route the thread segments travel in the helical and/or translational track.
  • An audible and/or tactile signal could then be delivered when the raised knob engages or disengages with one of the lowered portions of the thread segment.
  • the second toothed rack and the gear wheel are rotated out of engagement with each other. This is preferably done by rotating the second toothed rack radially around the longitudinal axis of the injection device to thereby disengage the second toothed rack and the gear wheel.
  • the second toothed rack is preferable linked to the dose selection button to rotate together with the dose selection button during dose selection.
  • the dose selection button is preferably rotated one full revolution to select the dose to be ejected.
  • the full revolution secures that the second toothed rack of the dose selection button always ends up in a position in which the second toothed rack is re-engaged with the gear wheel carried by the piston rod.
  • the rotational span can easy be selected by the manufacturer to be less than one full revolution simply by changing the intersection between the helical track used during dose selection and the position of the translational track used during expelling of the selected pre-defined fixed dose.
  • the housing structure preferably comprises a housing part and a cartridge holder releasable coupled together along the centre axis.
  • the cartridge holder carries a replaceable cartridge and, in another example, the cartridge is embedded in the cartridge holder to form a drug unit or cartridge unit which is replaceable as a whole.
  • the cartridge holder which could also be referred to as the cartridge unit, is preferably connected to the housing part by a bayonet coupling.
  • a cradle supporting the piston rod and carrying the first toothed rack is rotatable connected to the housing structure such that the cradle can be rotated via its engagement with the cartridge holder.
  • the gear wheel which is rotatable connected to the piston rod, preferably at a proximal end thereof also follows the rotation of the cradle to be rotated out of engagement with the second toothed rack during rotation of the cradle by the cartridge holder.
  • the cradle is in one example operational considered a part of the housing structure as the cradle at any time is longitudinal fixated in the housing structure. However, the cradle is thus only axially fixated in the housing structure and hence able to rotate relatively to the housing structure.
  • the cradle is able to pivot in relation to the housing structure preferably between two different positions.
  • the cradle thus being considered a pivotable element associated with the housing structure.
  • an End-of-Content mechanism is provided.
  • An End-of- Content mechanism is generally a mechanism which prevents the user from selecting a further dose once the initial quantum of liquid drug in the cartridge has been used.
  • an end-of-content mechanism secures that once the last of the pre-determined number of doses has been expelled the user cannot select a full dose anymore.
  • such End-of-Content mechanism for the multiple fixed dose device comprises a flexible element such as a small arm or the like connected to, or being part of, the dose selection button which flexible element is bended radially outwardly to engage with the housing structure when a predetermined number of fixed doses has been set and ejected.
  • a flexible element such as a small arm or the like connected to, or being part of, the dose selection button which flexible element is bended radially outwardly to engage with the housing structure when a predetermined number of fixed doses has been set and ejected.
  • the flexible element is bended radially outwardly by the gear wheel when the gear wheel has been moved to its preferred end position.
  • the flexible element preferably engages with the housing structure e.g. via a stop protrusion provided on an inner surface of the housing structure. Hence, the position of this stop protrusion, the position of the flexible element and the position of the gear wheel in its end position defines when the dose selection button is being blocked for further rotation.
  • the multiple fixed dose device is designed to expel four equally sized doses, hence the piston rod is moved forward in the distal direction four times wherein each movement has the same translational distance such that the same volume is expelled in each of the four movements.
  • the pre-defined fixed doses thus refer to the volume ejected. Although the same volume is ejected each time the injection device is operated, the liquid drug contained in different cartridges or cartridge units can have different strengths. Following the fourth and last movement, the gear wheel is brought to its end position and is radially positioned adjacent to the flexible element.
  • the gear wheel will abut and force the flexible element outwardly to engage with the housing structure thus hindering the user in selecting a fifth dose.
  • the engagement between the flexible element and the inner surface of the housing structure can be refined by providing a protrusion of the inner surface of the housing structure and/or provided the flexible element with an engagement feature.
  • the multiple fixed dose injection device described herein is provided with a cartridge change system wherein rotation of the cartridge holder disengages the engagement between the second toothed rack and the gear wheel thereby allowing the piston rod in being moved to its initial position.
  • the cartridge holder is forced to rotate when connected to or disconnected from the housing part containing the drive mechanism due to a bayonet interface, this rotation of the cartridge holder is then utilized to rotate the gear wheel out of engagement with the second toothed rack. Once there is no engagement between the gear wheel and the second toothed rack, the piston rod carrying the gear wheel can be pushed translationally back to its initial position.
  • the cartridge holder being either a regular cartridge holder holding an exchangeable cartridge or a cartridge holder formed as a cartridge unit having a cartridge permanently and irreversible embedded therein.
  • the cartridge holder, or cartridge unit if the cartridge is irreversible fixed in the cartridge unit engages and rotates the cradle.
  • the cradle can thus be in a position in which gear wheel is in contact with the second toothed rack of the dose selection button or the cradle can be pivoted (i.e. rotated) by the cartridge holder to a position wherein the gear wheel is disconnected from the second toothed rack such that the gear wheel and the piston rod can be pressed axially back to its initial position before a new cartridge or cartridge unit is attached.
  • the cradle is preferably able to pivot (rotate) around the longitudinal axis (X) of the housing structure.
  • the multi-use fixed dose injection device herein described and claimed can be either a pre-filled injection device or a re-usable injection device.
  • the multiuse fixed dose injection device described herein consist of only eight simple parts or components which are all preferably moulded from a suitable plastic.
  • the eight components are preferably made from the same polymer or at least from polymers which can be re-cycled together.
  • components which are physically linked together can be made from the same polymer or type of polymers thus being recyclable together without disassemble the linked components.
  • the eight parts are preferably coupled together by using techniques which makes its relatively easy to dissemble the injection device such as threads or simple click fasteners.
  • one or more of the polymers parts can however be moulded from an already re-cycled polymer.
  • the polymer parts being made from re-cycled polymers are preferably the parts not requiring very strict tolerances such as the protective cap and/or the cartridge holder.
  • the polymer parts could also be moulded from other biodegradable materials such as e.g. polymers produced from sugar or e-methanol i.e. methanol produced from renewable energy sources such as wind or solar energy.
  • biodegradable materials such as e.g. polymers produced from sugar or e-methanol i.e. methanol produced from renewable energy sources such as wind or solar energy.
  • Other fossil replacement materials as well as other naturally biological degradable materials could also be used.
  • injection pen or “pen for injection” is typically an injection apparatus having an oblong or elongated shape somewhat like a pen for writing. Although such pens usually have a tubular cross-section, they could easily have a different cross-section such as triangular, rectangular or square or any variation around these geometries.
  • needle Cannula is used to describe the actual conduit performing the penetration of the skin during injection.
  • a needle cannula is usually made from a metallic material such as e.g. stainless steel and connected to a hub to form a complete injection needle also often referred to as a “needle assembly”.
  • a needle cannula could however also be made from a polymeric material or a glass material.
  • the hub also carries the connecting means for connecting the needle assembly to an injection apparatus and is usually moulded from a suitable thermoplastic material.
  • the “connection means” could as examples be a luer coupling, a bayonet coupling, a threaded connection or any combination thereof.
  • Needle unit is used to describe one single needle assembly carried in a container.
  • Such container usually has a closed distal end and an open proximal end which is sealed by a removable seal.
  • the interior of such container is usually sterile such that the needle assembly is ready to use.
  • Needle units specially designed for pen injection systems are defined in ISO standard No. 11608, part 2, and are often referred to as “pen needles”.
  • Pen needles are usually double pointed having a front-end for penetrating through the skin of a user and a back-end for penetrating into the cartridge containing the drug such that liquid communication is established during injection.
  • Liquid drug is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hollow needle cannula in a controlled manner, such as a liquid, solution, gel or fine suspension.
  • Representative drugs include pharmaceuticals such as peptides, proteins (e.g. insulin, insulin analogues and C-peptide), and hormones, biologically derived or active agents, hormonal and gene-based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
  • peptides e.g. insulin, insulin analogues and C-peptide
  • hormones e.g. insulin, insulin analogues and C-peptide
  • hormones e.g. insulin, insulin analogues and C-peptide
  • hormones e.g. insulin, insulin analogues and C-peptide
  • hormonal and gene-based agents e.g., hormonal and gene-based agents
  • nutritional formulas and other substances in both solid (dispensed) or liquid form.
  • Cartridge is the term used to describe the container or ampoule actually containing the drug which are often referred to as the primary packing as it is in direct contact with the liquid drug. Cartridges are usually made from glass but could also be moulded from a suitable polymer. A cartridge or ampoule is preferably sealed at one end by a pierceable membrane referred to as the “septum” which can be pierced e.g. by the non-patient end of a needle cannula. Such septum is usually self-sealing which means that the opening created during penetration seals automatically by the inherent resiliency of the septum material once the needle cannula is removed from the septum.
  • the opposite end of the cartridge is typically closed by a movable “plunger” which is a piston-like element made from rubber or a suitable polymer.
  • the plunger is during use slidable moved inside the cartridge preferably in a distal direction.
  • the space between the pierceable membrane and the movable plunger holds the liquid drug which is pressed out as the plunger decreased the volume of the space holding the liquid drug.
  • the cartridges used for both pre-filled injection devices and for durable injections devices are typically factory filled by the manufacturer with a predetermined volume of a liquid drug.
  • a large number of the cartridges currently available contains either 1 ,5 ml or 3 ml of liquid drug.
  • Pre-filled injection device an injection device in which the cartridge containing the liquid drug is filled by the manufacture of the injection device at a factory facility and permanently embedded in the injection device such that it cannot be removed without permanent destruction of the injection device. Once the pre-filled amount of liquid drug in the cartridge is used, the user normally discards the entire injection device. Usually, the cartridge which has been filled by the manufacturer with a specific volume of liquid drug is secured in a cartridge holder which is then permanently connected in a housing structure such that the cartridge cannot be exchanged.
  • the cartridge is permanently and irreversible embedded in a plastic shell or the like which is removable attached to the housing of the injection device.
  • plastic shell comprising a cartridge permanently embedded therein is often referred to as a “Cartridge unit”.
  • Pre-defined fixed dose is meant a dose of the liquid drug having a predefined fixed volume which is determined by the manufacturer of the injection device and are inherent in the injection device such that the user can only select and expel one or more of the pre-defined fixed doses without any possibility for the user to change the volume of the fixed dose.
  • 2 to 8 pre-defined fixed doses, and preferably 4 to 6 predefined doses, are available in one injection device.
  • Figure 1 A show a side view of the injection device with the protective cap mounted.
  • Figure 1 B show a side-view of the injection device without the protective cap.
  • Figure 2 show an exploded view of the injection device according to the invention.
  • Figure 3A show a cross-sectional view of the injection device in the initial start position.
  • Figure 3B show a cross-sectional view similar to that of figure 3A, however, the injection device has been rotated 90° around the longitudinal axis (X).
  • Figure 4 show a cross-sectional view of the injection device wherein the first predefined fixed dose has been selected.
  • Figure 5 show a perspective view of the gear wheel.
  • Figure 6A-B show different perspective views of the piston rod.
  • Figure 7A-B show different perspective views of the housing part.
  • Figure 8A-B show different perspective views of the cartridge holder.
  • Figure 9 show a perspective view of the protective cap.
  • Figure 10 show a perspective view of the cradle.
  • Figure 11 show a perspective view of the bearing.
  • Figure 12 show a perspective view of the dose selection button.
  • Figure 13A-B show different side views of the dose selection button.
  • Figure 13C show a view of the first thread segment inside the housing part.
  • Figure 14A show a cross-sectional view of the injection device with the piston rod in the end position.
  • Figure 14B show a side view of the injection device with the housing structure visually removed.
  • Figure 14C show a cross-sectional view along the line AA in figure 14B.
  • Figure 15 show an example of a cartridge unit and a different housing structure.
  • distal end in the appended figures is meant to refer to the end of the injection device supporting the injection needle, whereas the term “proximal end” is meant to refer to the opposite end carrying the dose selection button as indicated in figure 1.
  • Distal and proximal is meant to be along an axial orientation extending along the longitudinal axis (X) of the injection device as also shown in figure 1A-B and in figure 3A-B.
  • Translational movement is meant to be a strictly linear movement without any rotation.
  • “Rotational movement” is any movement of rotation around a centre which centre can be a centre point i.e. in one planar or a centre axis i.e. having a longitudinal extension.
  • Axial movement means any movement in an axial direction. Such movement can be a strictly translational movement or include a rotational movement which thus makes it a “Helical movement” as this is meant to be an axial movement combined with a rotational movement.
  • axial is meant in a lengthwise direction but not necessarily along a straight line.
  • Diadial is meant to be at an angle to the axial direction. The angle is not necessarily 90° hence the radial direction is not necessarily perpendicular to the axial direction.
  • Telescopic is meant to cover the situation in which a movable element moves out from, and/or into, a base element. The telescopic movement can be either translational or include a rotation thus making the telescopic movement helical.
  • Figure 1A-B discloses the multiuse fixed dose device as it is delivered to a user.
  • the outer shell of the injection device herein referred to as the housing structure, comprises a housing part 10 and a cartridge holder 30 which are releasable coupled together.
  • the cartridge holder 30 or part thereof Prior to use, the cartridge holder 30 or part thereof is covered by a protective cap 5 which is to be removed before using the injection device.
  • a cartridge 40 containing the liquid drug to be injected is secured by the cartridge holder 30.
  • the cartridge 40 is preferably a so-called PenFill® wherein a plastic adapter top 41 carrying the needle mounted is secured at the distal end of the cartridge 40.
  • the needle mount can be a part of the cartridge holder 30.
  • the injection device is provided with a dose selection button 20 which the user rotates out from the housing part 10 to select the fixed dose to be injected.
  • the dose selection button 20 is in the disclosed example a longitudinal tube shape component which at the proximal end has a finger grip 22.
  • FIG. 2 and figure 3A-B discloses different views of the injection device with the dose selection button 20 in the initial position.
  • the shell of the injection device comprises the housing structure made up from the housing part 10 and the cartridge holder 30.
  • the housing part 10 guides the dose selection button 20 which has both a helical interface and a translational interface with the housing part 10.
  • the dose selection button 20 is helically interfaced with the housing part 10 such that the dose selection button 20 rotates helically out from the proximal end of the housing part 10 during dose selection.
  • the dose selection button 20 is to be pushed translationally and axially back into the housing part 10 by the user as will be explained.
  • the housing part 10 carries the cartridge holder 30 which secures an exchangeable cartridge 40.
  • the cartridge 40 is preferably made from glass and is distally provided with a membrane 42 to be pierced by a double pointed injection needle.
  • the cartridge 40 is provided with a movable piston or plunger 43 which can be moved in the distal direction by a piston rod 50.
  • the cartridge holder 30 is preferably connected to the housing part 10 by a bayonet interface.
  • the cartridge 40 can be removed from the cartridge holder 30 in order to insert a new and fresh cartridge 40 whereafter the cartridge holder 30 is attached to the housing part 10.
  • the cartridge 40 could also be permanently embedded or incapsulated in the injection device to form a so-called pre-filled injection device.
  • the cartridge 40 could be permanently retained in the cartridge holder 30, such that the cartridge 40 and the cartridge holder 30 together form a disposable drug containing unit which can be removed and replaced by a new and fresh drug containing unit.
  • a new and fresh drug containing unit i.e. a cartridge and a cartridge holder permanently locked together would thus be required for each exchange.
  • the cartridge holder 30 and the cartridge 40 could hence be permanently coupled together by the cartridge holder 30 having a protrusion, a knob, or the like which the cartridge 40 has to pass during assembly and which hinders the cartridge 40 from being removed from the cartridge holder 30 once it is inserted into the cartridge holder 30.
  • the cartridge holder 30 can be formed from one or more parts which are irreversible click-fitted together to permanently secure the cartridge 40.
  • the injection device is disclosed in the initial start position before any dose is selected and ejected.
  • the plunger 43 is located proximally inside the cartridge 40 and the dose selection button 20 is in abutment with the housing part 10.
  • the piston rod 50 is in its most proximal position. In this position, the piston rod 50 preferably abuts the plunger 43 such that any movement of the piston rod 50 in the distal direction is directly transferred to a similar movement of the plunger 43.
  • the plunger 43 and the piston rod 50 are mounted such that a small pressure is applied onto the plunger 43 to thereby eliminate tolerances and avoiding an air-gap between the piston rod 50 and the piston 53.
  • the piston rod 50 abuts the movable plunger 43 inside the cartridge 40 such that a further forward movement in the distal direction will build up pressure inside the cartridge 40 and thus force the liquid drug to flow out through a double pointed injection needle attachable to the needle mount on the adapter top 41 at the distal end of the cartridge 40.
  • the piston rod 50 is further provided with a gear wheel 80 such that the piston rod 50 and the gear wheel 80 makes up a piston rod assembly.
  • This gear wheel 80 can be provide in any random position on the piston rod 50 but is preferably attached at the proximal half of the piston rod 50 and most preferably attached to the proximal end of the piston rod 50.
  • a flexible arm 52 provided on the piston rod 50 obstructs the free rotation of the gear wheel 80 as will be explained.
  • the piston rod 50 is disclosed in figure 6A-B and comprises a distal end which is able to abut the movable plunger 43 inside the cartridge 40 during dose expelling.
  • the distal end of the piston rod 50 is provided with a piston rod foot 51 to better distribute the forces onto the plunger 43.
  • this foot 51 can be moulded as an integral part of the piston rod 50 or alternatively configured as a separate part which is attached to the piston rod 50.
  • the distal end of the housing part 10 is further provided with through-going radial openings 13 through which second protrusions 62 provided on the cradle 60 extend thereby locking the cradle 60 axially to the housing part 10. This is also seen in figure 3B.
  • the housing part 10 is also provided with an inner stop protrusion 16 on the inner surface which is part of the End-of-Content mechanism.
  • Cartridge Holder (30) The cartridge holder 30 disclosed in figure 8A-B is distally provided with a ring of teeth 35 which is able to engage and rotationally secure the adapter top 41 of a cartridge 40 as it is generally known in the art.
  • the position of the piston rod relative to the cartridge holder 30, are preferably scanned or photographed by a camera e.g. a camera in a smartphone.
  • the scanned or photographed image can thereafter be processed in an app or the like stored in the smartphone to provide the user with information regarding the selected doses.
  • This information could e.g. refer to the consumption of the fixed doses e.g. which number of dose are being used and how many doses are left in the cartridge which further can support the user in ordering new cartridges for the injection device, e.g. in an automated process.
  • the cartridge 40 and the cartridge holder 30 can be permanently connected to form one drug containing unit which can easily be replaced by a new and fresh drug containing unit using the bayonet interface 11, 32.
  • the bayonet interface 11 , 32 the bayonet protrusions 32 and the bayonet track 11 can be placed on either of the cartridge holder 30 or on the housing part 10 respectively.
  • the cartridge holder 30 is further provided with a number of inwardly pointing knobs 36 for engaging and rotating the cradle 60 as will be explained. In the disclosed example, two such knobs 36 are provided each having a longitudinal slot 37.
  • the cradle disclosed in figure 10 is moulded as a tube-shaped elongated structure wherein the distal part is shaped as a circumferential closed tube and the proximal part is shaped as an open half-circular structure having longitudinal sides 63.
  • the circumferential closed tube is internally, at least on a part thereof, shaped in the same shape as the piston rod 50 such that the piston rod 50 is able to slide inside the circumferential closed tube but unable to rotate relatively to the cradle 60.
  • the piston rod 50 and the cradle 60 can only move axially in relation to each other.
  • a bearing 70 associated with the dose selection button 20 is disclosed in detail in figure 11.
  • the bearing 70 is shaped as a tube-like elongated element having a longitudinal opening 71 and a plurality of radial flanges 72 further supporting the dose selection button 20.
  • the bearing 70 is provided with an outwardly pointing flange 73 (also seen in figure 3A-B) which is secured in a recess provided on the inner surface of the dose selection button 20 making the dose selection button 20 rotational in relation to the bearing 70.
  • the bearing 70 is further provided with an inner recess 74 guided by the longitudinal sides 63 of the cradle 60 such that the bearing 70 cannot rotate relatively to the cradle 60 but is able to rotate together with the cradle 60.
  • the bearing 70 follows the axial movement without rotating as it is rotationally locked by the cradle 60 which again is rotationally locked to the housing part 10.
  • the gear wheel 80 protrudes out though the longitudinal opening 71 of the bearing 70 to engage a second toothed rack 21 provided on the inner surface of the dose selection button 20 as will be explained.
  • the dose selection button 20 is disclosed in figure 12. As seen in figure 12, the inner side is provided with the second toothed rack 21 for moving the gear wheel 80. Also, on the inner surface a flexible EoC arm 45 is provided which is able to be bended outwardly to engage with the housing part 10 following the ejection of the last dose as will be explained.
  • the dose selection button 20 has a grip 22 which a user would grip between the fingers to rotate the dose selection button 20.
  • the grip 22 can in one example be made from a softer polymeric material than the remaining part of the dose selection button 20, either in a 2K moulding or by making the grip 22 as a separate band or separate part connected to the dose selection button 20.
  • On the outer surface the dose selection button (20) is provided with different tracks wherein at least one is a helical track 23.
  • the user rotates the dose selection button 20 helically out from the housing part 10 following the helical track 23 on the dose selection button 20.
  • the toothed rack 21 on the inner surface of the dose selection button 20 is rotated radially out of engagement with the gear wheel 80 which allows the dose selection button 20 to follow the pitch of the helical track 23 on the dose selection button 20.
  • Figure 4 discloses the situation in which the user has selected the first dose.
  • the dose selection button 20 has been rotated one full revolution and the first toothed rack 21 has reengaged the gear wheel 80.
  • the toothing inside the dose selection button 20 do not need to engage with the gear wheel 80 in the initial position, however the second toothed rack 21 needs to engage with the gear wheel 80 when a dose is selected.
  • the dose selection button 20 is further disclosed in figure 13A-B.
  • figure 13B is rotated 90° clockwise when compared with figure 13A.
  • a helical track 23 for guiding the dose selection button 20 during dose selection is provided on the distal half of the outer surface of the dose selection button 20, a helical track 23 for guiding the dose selection button 20 during dose selection is provided. As best seen on figure 13B, this helical track 23 connects to a translational track 24 which guides the dose selection button 20 during dose expelling.
  • the first thread segment 15a (indicated by punctured lines in figure 13A-B) on the inner surface of the housing part 10 is located in the start of the helical track 23 as indicated with broken lines.
  • the dose selection button 20 When a user rotates the dose selection button 20 counterclockwise (as seen from a position distal to the injection device) to select one of the fixed doses, the first thread segment 15a is moved along the arrow “S” in the helical track 23 (the rotational part is though the dose selection button). Following a rotation of one full revolution, the first thread segment 15a enters into the translational track 24 as indicated in figure 13B.
  • a second guiding system can be provided.
  • This system takes form in a second thread segment 15b, also indicated by punctured lines in figure 13A.
  • this second thread segment 15b is guided in a similar helical track 28 and after one full revolution, the second thread segments 15b is guided translationally in a parallel translational track 29 during dose expelling.
  • the first thread segment 15a is preferably shaped with two lowered portions 17a,b as shown in figure 13C wherein the housing part 10 is cut open.
  • a first raised knob 25 in the helical track 23 is positioned in the first lowered portion 17a.
  • the first raised knob 25 snaps out of the first lowered portion 17a which provides the user with a tactile signal that dose selection has been initiated.
  • a second raised knob 26 is provided in the translational track 24. Once the first thread segment 15a enters into the translation track 24, the second lowered portion 17b is caught by this second raised knob 26 providing the user with a further tactile signal informing that the fixed dose has now been selected and can now be released.
  • the two lowered portions 17 a,b in combination with the two knobs 25, 26 being rotationally dislocated in the track 24 provides a very attractive feel to the user when selecting the fixed dose.
  • the dose selection button 20 is proximally in the translational track 24 provided with a flexible wing 27 which can only be passed by the first thread segment 15a in the direction used when expelling the fixed dose. i. e pushing the dose selection button 20 translational in the distal direction. Once the fixed dose has been expelled it is thus not possible to pull the dose selection button 20 away from the housing part 10 as this is hindered by the flexible wing 27 engaging the first thread segment 15a as seen in figure 13A.
  • the second toothed rack 21 provided on the inner surface of the dose selection button 20 is rotated radially out of engagement with the gear wheel 80 which is rotationally locked in the radial direction by the engagement of the piston rod 50 with the cradle 60.
  • the dose selection button 20 is free to rotate independently of the gear wheel 80 following the engagement between the thread segments 15a, 15b and the helical tracks 23, 28.
  • the dose selection button 20 is to be rotated one full revolution the set a dose.
  • the rotational distance from disengagement between the gear wheel 80 and the second toothed rack 21 to a new engagement is thus preferably around 360°.
  • the helical interface to the dose selection button 20 can be such that the dose selection button 20 can be rotated less than one full revolution
  • the second toothed rack 21 has again radially engaged with the gear wheel 80 in a position dictated by the pitch of the helical track 23 on the dose selection button.
  • the pitch of the helical track 23 thus determines the distance the dose selection button 20 is moved out from the housing part 10 and thus determined the length the dose selection button 20 is translated during dose expelling.
  • the distance that the piston rod 50 is moved during dose expelling and the diameter of the cartridge 40 determines the volume of the fixed dose to be delivered. It is thus possible to alter the delivered volume simply by using a different pitch of the helical track 23 and dose selection buttons 20 with different pitches can thus accommodate different dose volumes.
  • the first thread segment 15a slides proximally inside the translational track 24 following the arrow “E” as indicated in figure 13B and once the fixed dose has been expelled, the first thread segment 15a is captured by the first raised knob 25 and the flexible wing 27.
  • the flexible EoC arm 45 provided in the structure of the dose selection button 20 will be bended outwardly and engage with the inner stop protrusion 16 inside the housing part 10 as disclosed on figure 14C.
  • This inner stop protrusion 16 is also shown on figure 7B. The engagement between the outwardly bended EoC arm 45 and the inner stop protrusion 16 will prevent the dose selection button 20 from being rotated further and the user can therefore not select a new dose.
  • the engagement between the first protrusions 61 and the longitudinal recesses 12 inside the housing part 10 both guides the rotation and provides the user with a tactile signal.
  • two such longitudinal recesses 12 are provided for each first protrusion 61, hence in the disclose example; four recesses 12 and two first protrusions 61 are provided.
  • the cradle 60, the bearing 70, the piston rod 50 and the gear wheel 80 are thus rotatable between two different positions, a first position wherein the gear wheel 80 is engaged with the second toothed rack 21 associated with the dose selection button 20 and a second position wherein the gear wheel 80 is rotated out of engagement with the second toothed rack 21. In the latter position, the piston rod 50 with the gear wheel 80 can be moved translational backwards to the initial position as the gear wheel 80 rolls on the first toothed rack 65 associated with the cradle 60 and thus the housing part 10.
  • the user can hence push the piston rod 50 back into the housing part 10 and into the cradle 60.
  • the abutment between the proximal end of the piston rod 50 and the end flanges 66 proximally on the cradle 60 indicates that the piston rod 50 has been pushed back to its initial position.
  • this axial sleeve 119 When connecting the cartridge unit 130 to the housing structure 110, this axial sleeve 119 enters into the radial space between the cartridge itself and the polymer housing of the cartridge unit 130.
  • the proximal part of the cartridge unit 130 partly covering the housing structure proximal to the axial sleeve 119 when the cartridge unit 130 is mounted preferably carries a label which can be inspected by a user at any time, even after a protective cap has been connected to the distal part of the cartridge unit 130.

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  • 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

L'invention concerne un dispositif d'injection de doses fixes à usage multiple pour éjecter de multiples doses fixes prédéfinies d'un médicament liquide. Le dispositif d'injection comprend une structure de boîtier, un bouton de sélection de dose et un ensemble tige de piston. La structure de boîtier est conçue pour maintenir une cartouche chargée contenant le médicament liquide. Le bouton de sélection de dose est fonctionnellement couplé à la structure de boîtier pour sélectionner l'une de la dose fixe prédéfinie et l'ensemble tige de piston est adapté distalement pour déplacer un piston à l'intérieur de la cartouche chargée et adapté pour porter une roue dentée, qui est couplée de manière rotative à une tige de piston. Le dispositif d'injection comprend en outre une première crémaillère dentée associée à la structure de boîtier et une seconde crémaillère dentée associée au bouton de dose. La roue dentée et la première crémaillère dentée sont en prise permanente à la fois pendant la sélection de dose et pendant l'éjection de dose, et la roue dentée et la seconde crémaillère dentée sont désengagées pendant la sélection de dose et mises en prise pendant l'éjection de dose.
PCT/EP2025/057378 2024-03-21 2025-03-18 Dispositif d'injection pour délivrer une pluralité de doses fixes prédéfinies Pending WO2025196054A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP24165122.3 2024-03-21
EP24165122 2024-03-21

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WO2025196054A1 true WO2025196054A1 (fr) 2025-09-25

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5304152A (en) 1990-03-29 1994-04-19 Bernard Sams Dispensing device
WO1996026754A2 (fr) * 1995-02-28 1996-09-06 Bernard Sams Mecanisme incrementiel destine en particulier a une seringue a membrane
WO2003080160A1 (fr) 2002-03-18 2003-10-02 Eli Lilly And Company Appareil de distribution de medicament dote d'un train d'engrenages apportant un avantage technique
US20110306947A1 (en) * 2008-12-02 2011-12-15 Sanofi-Aventis Deutschland Gmbh Medication delivery device and method for operating a medication delivery device
WO2020089167A1 (fr) 2018-10-30 2020-05-07 Novo Nordisk A/S Dispositif d'injection entraîné par un ressort de torsion

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5304152A (en) 1990-03-29 1994-04-19 Bernard Sams Dispensing device
WO1996026754A2 (fr) * 1995-02-28 1996-09-06 Bernard Sams Mecanisme incrementiel destine en particulier a une seringue a membrane
WO2003080160A1 (fr) 2002-03-18 2003-10-02 Eli Lilly And Company Appareil de distribution de medicament dote d'un train d'engrenages apportant un avantage technique
US20110306947A1 (en) * 2008-12-02 2011-12-15 Sanofi-Aventis Deutschland Gmbh Medication delivery device and method for operating a medication delivery device
WO2020089167A1 (fr) 2018-10-30 2020-05-07 Novo Nordisk A/S Dispositif d'injection entraîné par un ressort de torsion

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