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WO2025195750A1 - Dispositif d'administration de médicament et ensemble d'administration de médicament - Google Patents

Dispositif d'administration de médicament et ensemble d'administration de médicament

Info

Publication number
WO2025195750A1
WO2025195750A1 PCT/EP2025/055621 EP2025055621W WO2025195750A1 WO 2025195750 A1 WO2025195750 A1 WO 2025195750A1 EP 2025055621 W EP2025055621 W EP 2025055621W WO 2025195750 A1 WO2025195750 A1 WO 2025195750A1
Authority
WO
WIPO (PCT)
Prior art keywords
dosing
driver
medicament delivery
rotation
ratchet
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/EP2025/055621
Other languages
English (en)
Inventor
Staffan BURÉN
Daniel SÄLL
Daniel Carlsson
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.)
SHL Medical AG
Original Assignee
SHL Medical AG
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 SHL Medical AG filed Critical SHL Medical AG
Publication of WO2025195750A1 publication Critical patent/WO2025195750A1/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
    • A61M5/31545—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
    • A61M5/31553—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without 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
    • A61M5/31565—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
    • A61M5/31585—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 axially moving actuator, 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • A61M5/2422—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule

Definitions

  • the invention is in the field of medicament delivery devices.
  • it relates to automatic medicament delivery devices.
  • the invention more particularly relates to medicament delivery devices for delivering multiple doses of a medicament from one medicament container, more specifically, wherein a user can set the dosing amount to be delivered (variable dose medicament delivery device).
  • Medicament delivery devices for automatic delivery of a medicament by selfadministration are well-known. Especially, they may be equipped to accommodate a medicament container, for example a medicament container with a septum (or another seal) to be perforated immediately prior to use, or a syringe. Often, the medicament delivery device and the medicament container are pre-assembled to constitute a medicament delivery assembly for self-administration.
  • a medicament container for example a medicament container with a septum (or another seal) to be perforated immediately prior to use, or a syringe.
  • the medicament delivery device and the medicament container are pre-assembled to constitute a medicament delivery assembly for self-administration.
  • Automatic medicament delivery devices which have a pretensioned spring which stores and provides, when a dose release mechanism is activated, the energy required for expelling the medicament from the medicament container.
  • medicament delivery device which can expel multiple doses of a medicament from one medicament container, wherein for each dose, the user can set a desired dosing amount by means of a dose setting mechanism.
  • the user sets a false dosing amount. If the false amount is too low, the user can, in case of various known medicament delivery devices, simply continue the setting process until the desired dosing amount is reached. However, it may happen that the user accidentally sets a too high dose. If the dose setting mechanism does not provide the possibility to correct the dosing amount to a lower value, the dose has to be discarded, and the user has to set the dosing amount anew afterwards.
  • a drug delivery device with reset mechanism is known.
  • the user can set (and increase) a dosing amount by turning a dose setting member in a clockwise (cw) direction, and turn the dose setting member in a counter clockwise (ccw) direction to decrease the dosing amount.
  • the dose setting mechanism involves two ratchet mechanisms.
  • the device should have a high usability and should be safe.
  • Another object of the invention is to provide a medicament delivery device which does not increase its length more and more with increasing dosing amounts set by the user.
  • Another object of the invention is to provide a medicament delivery device which can display an indication of a set dosing amount in a simple way.
  • Another object of the invention is to provide a medicament delivery device which can be manufactured relatively simply.
  • Another object of the invention is to provide a medicament delivery device which comprises a relatively low number of parts to be assembled.
  • the dose setting mechanism comprises
  • ratchet mechanism in particular a releasable one-way ratchet mechanism
  • the first dosing member and the second dosing member are rotationally coupled to one another and axially movable relative to one another. This is more particularly the case in both, in the setting state and in the correcting state (cf. below).
  • An angle of rotation assumed by the first dosing member determines (defines) the dosing amount.
  • the user can set a dosing amount by setting a said angle or rotation. More particularly, it is an angle of rotation assumed by the first dosing member at the time of starting the expelling of a dose (in particular: at the time of releasing the dose release mechanism, cf. below) which determines the dosing amount.
  • Said angle of rotation can be an angle relative to an initial rotational position of the first dosing member.
  • Said angle of rotation assumed by the first dosing member is an angle of rotation assumed by the second ratchet structure relative to an initial rotational position of the the second ratchet structure - because the first and second dosing members are rotationally locked to one another, and the second ratchet structure is comprised in the second dosing member.
  • Said angle of rotation assumed by the first dosing member can also be identified with an angle of rotation by which the second dosing member (and thus the second ratchet structure) is rotated relative to the first ratchet structure (and thus relative to the driver assembly) during setting / correcting a dosing amount (using the dose setting mechanism).
  • the ratchet mechanism comprises a first ratchet structure which is rotationally locked to, in particular comprised in, the driver assembly, and a second ratchet structure rotationally locked to, in particular comprised in, the second dosing member.
  • the first and second ratchet structures are engaged with one another, and, in a correcting state, they are disengaged from one another. Furthermore, in the setting state, they
  • ratchet structures and their interaction can be implemented in a way are known in the art.
  • a rotation of the second dosing member and thus of the second ratchet structure relative to the first ratchet structure in the first sense of rotation can be considered a setting movement.
  • rotational movements of the two parts are locked to one another - e.g., rotational movements of the driver assembly are locked to (and thus identical to) rotational movements of the first ratchet structure; and rotational movements of the second ratchet structure are locked to (and thus identical to) rotational movements of the second dosing member.
  • the second dosing member is operable, in particular rotatable, by the user to set and to correct (if desired) a dosing amount.
  • a rotation of the second ratchet structure relative to the first ratchet structure is, by the ratchet mechanism, inhibited neither in a first sense of rotation nor in the second sense of rotation.
  • the set-control biasing member is configured to bias the second dosing member in a second axial direction, e.g., in a proximal direction, to bias the second ratchet structure to engage with the first ratchet structure.
  • the biasing can bias the second dosing member towards the setting state.
  • the biasing can more specifically be a biasing relative to the base assembly.
  • the control mechanism is operable by a user to selectably switch between the setting state and the correcting state by the user causing a first movement of the second dosing member into the first axial direction, e.g., towards distally, to switch from the setting state into the correcting state, and by the user causing a second movement of the second dosing member into a second axial direction opposite the first axial direction, e.g., towards proximally, to switch from the correcting state into the setting state.
  • the user can switch between the setting state and the correcting state and thus engage and disengage the first and second ratchet structures.
  • the first movement is a movement into the first axial direction.
  • a change from setting to correcting involves a rotating movement caused by the user.
  • the dosing amount setting and correcting can this way be implemented in a user-friendly and intuitively operable way.
  • the medicament delivery device is relatively simple to manufacture, involving a not very high number of parts which are not particularly difficult to manufacture.
  • the medicament delivery device does not increase its length more and more with increasing dosing amounts set by the user. This will be come clearer from the description below.
  • the provision of the first and second dosing members makes possible that the medicament delivery device can display an indication of a set dosing amount in a simple way. This will be come clearer from the description below.
  • the user can cause the first movement, e.g., by pulling the second dosing member, in particular away from the base assembly. And the user can cause the second movement, e.g., by releasing the second dosing member, wherein the set-control biasing member then moves the second dosing member back, e.g., towards proximally and, e.g., towards the base assembly.
  • a dosing amount is settable by the user by rotating the second dosing member in the first sense of rotation
  • a set dosing amount is correctable by a user by rotating the second dosing member.
  • the latter may in particular take place in any of the first sense of rotation and of the second sense of rotation.
  • the user when the user merely rotates the second dosing member (in the first sense of rotation, as rotation in the second sense of rotation being blocked by the ratchet mechanism), the user can set a dosing amount.
  • This corresponds to the normal case of using the medicament delivery device.
  • the user causes the first movement to disengage the first and second ratchet structures, enabling him/her to apply corrections to the dosing amount set so far.
  • the second ratchet structure in the correcting state, the second ratchet structure is rotatable in both senses of rotation, i.e., cw as well as ccw, in the correcting state. Note that in the unusual case that the user would not initially set a dosing amount but initially already cause the first movement, a rotation of the second dosing member (and of the second ratchet structure) would initially be possible only in the first sense of rotation.
  • the first and second movements are, more specifically, movements relative to the base assembly and relative to the first ratchet structure.
  • the device axis is the axis about which the second dosing member is rotatable.
  • the device axis is the axis about which the driver assembly rotates in the driver movement.
  • a first end of the driver biasing member is rotationally locked (in particular is affixed) to the base assembly, and a second end of the driver biasing member is rotationally locked (in particular is affixed) to the second dosing member.
  • the driver biasing member is pre-tensioned such that a rotation of the second end relative to the first end in the first sense of rotation increases a bias of the driver biasing member.
  • one of the base assembly and of the first dosing member comprises a rotation-guiding feature, the other one comprising at least one cooperating feature cooperating with the rotation-guiding feature to guide rotational movements of the first dosing member relative to the base assembly.
  • the rotation-guiding feature comprises a first stop cooperating with the at least one cooperating feature to inhibit a rotation of the first dosing member in the second sense of rotation when the at least one cooperating feature abuts the first stop.
  • the rotational position of the first dosing member in which the at least one cooperating feature abuts the first stop is the initial rotational position.
  • the rotation-guiding feature comprises a second stop cooperating with the at least one cooperating feature to inhibit a rotation of the first dosing member in the first sense of rotation when the at least one cooperating feature abuts the second stop. This way, a maximum angle of rotation of the first dosing member and thus a maximum settable dosing amount can be implemented.
  • the rotation-guiding feature is a helical feature. This way, a rotation of the first dosing member causes an additional translational movement of the first dosing member.
  • the helical feature comprises a thread
  • the rotationguiding feature can be, .e.g., a circular groove in the base assembly, e.g., in a device body of the base assembly, which provides two stops, e.g., a groove of 350°, the io° being not grooved, thus providing, at one end, the first stop and, at its other end, the second stop.
  • the cooperating feature can be, e.g., a protrusion, e.g., a helical protrusion.
  • the medicament delivery device comprises a dose release mechanism operable by a user to release a dose.
  • the dosing amount of an expelled dose can be determined by the dosing amount set (and optionally corrected) when operating (releasing) the dose release mechanism.
  • the medicament delivery device comprises a dose release mechanism comprising a trigger element, wherein the trigger element is operable by a user to release a dose by bringing dose release mechanism from an inhibiting state into a releasing state, wherein the dose release mechanism is couplable to the driver assembly to block the driver movement in the inhibiting state and to enable the driver movement in the releasing state.
  • Operating the dose release mechanism accordingly, can suspend the rotational locking of the driver assembly.
  • the dose release mechanism is in the inhibiting state (not operated), it rotationally locks the driver assembly or, in other words, rotationally couples the driver assembly to the base assembly and to the device body, respectively.
  • the driver assembly can rotate, driven by the driver biasing member.
  • the dose release mechanism can for this purpose comprise a releasable (and re-engageable) splined connection between the trigger element and the driver assembly.
  • the trigger element is operable by a user to be movable from an inhibiting position in which the trigger element is coupled to the driver assembly to block the driver movement, to a releasing position in which the trigger element is decoupled from the driver assembly not to block the driver movement, the dose release mechanism further comprising a trigger biasing member biasing the activation element towards the inhibiting position.
  • the trigger biasing member keeps the trigger element in the inhibiting position (and the release mechanism in the inhibiting state), and for moving the trigger element into the releasing position (and bringing the release mechanism in the releasing state), the user has to counteract the bias of the trigger biasing member.
  • operating the trigger element is sliding the trigger element, in particular sliding the trigger element in a longitudinal direction.
  • Operating the trigger element can comprise sliding the trigger element.
  • the driver biasing member is a torsion spring, in particular a helical torsion spring
  • the driver assembly comprises a plunger nut device cooperating with the plunger rod device.
  • one of the plunger nut device and of the plunger rod device comprises a helical guidance feature
  • the other one comprises a guidance cooperation feature cooperating with the helical guidance feature to obtain the expelling movement from the driver movement, wherein the driver movement is a rotational movement.
  • one of the first dosing member and of the second dosing member comprises first longitudinal splines, the other one comprising second features cooperating with the first longitudinal splines to rotationally couple the first dosing member and the second dosing member to one another while enabling axial relative movements of the first dosing member and the second dosing member.
  • the second features can be, e.g., protrusions or longitudinal splines or longitudinal grooves.
  • the base assembly comprises a generally tubular shaped part, e.g., a device body, the second dosing member comprising a generally tubular shaped section located, at least in part, inside the generally tubular shaped part, at least one of the generally tubular shaped part and of the generally tubular shaped section comprising a guiding structure, the other one comprising a cooperating surface cooperating with the guiding structure to provide guidance for axial and rotational movements of the second dosing member (62) relative to the base assembly.
  • This is a way to enable guided axial movements of the second dosing member which in addition enable rotations of the second dosing member.
  • the second dosing member can comprise, in the tubular shaped section, outwardly protruding protrusions or an outwardly protruding circumferential ridge cooperating with an interior cylindrical surface of the base assembly, e.g., of a device body.
  • one of the base assembly and of the second dosing member comprises a first limiting feature, the other one comprising a second limiting feature, the first limiting feature and the second limiting feature cooperating to provide a stop limiting a distal movement of the second dosing member towards distally. This way, a stop is provided for the first movement or for the second movement (whichever is a distal movement).
  • the first axial direction is a proximal direction.
  • the user presses the second dosing member towards proximally to enter the correcting state, and, releasing the second dosing member, the set-control biasing member moves the second dosing member back towards distally into the setting state.
  • the first ratchet surface (cf. below) faces towards proximally.
  • the base assembly comprises a window
  • the second dosing member comprises a plurality of signs which are distributed over a circumference on an outside face of the second dosing member and arranged to be visible through the window in the setting state to indicate a set dosing amount.
  • the window can be an opening, or a region made of a transparent material.
  • the signs can be provided, e.g., on an outer surface of a generally tubular shaped section of the second dosing member.
  • the ratchet mechanism comprises a first ratchet surface which is aligned perpendicularly to the device axis, the first ratchet structure comprising a plurality of first ratchet teeth which protrude from the first ratchet surface and are radially extended and circumferentially distributed.
  • the ratchet mechanism further comprises a second ratchet surface facing the first ratchet surface, wherein the second ratchet surface which is aligned perpendicularly to the device axis, the second ratchet structure comprising a plurality of second ratchet teeth which protrude from the second ratchet surface and are radially extended and circumferentially distributed.
  • the first ratchet surface faces distally and the second ratchet surface faces proximally. Accordingly, the first ratchet teeth (8sd) protrude distally, whereas the second ratchet teeth (62d) protrude proximally.
  • first and second ratchet are possible, too, e.g., conical first and second ratchet surfaces are possible.
  • first ratchet surface is comprised in the driver assembly.
  • the second ratchet structure is distal relative to the first ratchet structure.
  • the first axial direction is proximal, and that for switching from the setting state to the correcting state, the user pushes the second dosing member proximally (i.e., the user moves the second dosing member proximally); and the first ratchet structure is distal of the second ratchet structure.
  • the second ratchet structure forms a unitary part with the second dosing member. This simplifies the manufacture, reducing the number of parts to be manufactured and assembled.
  • the medicament delivery device is a disposable medicament delivery device.
  • the medicament delivery device is a re-usable medicament delivery device.
  • the medicament delivery device in particular is a variable dose (settable dose) medicament delivery device.
  • the medicament delivery device in particular is ab automatic medicament delivery device.
  • the medicament delivery assembly comprises the medicament delivery device as herein described and further comprises the medicament container assembled with the medicament delivery device.
  • distal direction refers to the direction pointing away from the dose delivery site during use of the medicament delivery device.
  • distal part/end refers to the part/end of the delivery device, or the parts/ends of the members thereof, which during use of the medicament delivery device is/are located furthest away from the dose delivery site.
  • proximal direction refers to the direction pointing towards the dose delivery site during use of the medicament delivery device.
  • proximal part/end this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which during use of the medicament delivery device is/are located closest to the dose delivery site.
  • longitudinal refers to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and/or component.
  • transverse refers to a direction generally perpendicular to the longitudinal direction.
  • Figure 1A a perspective view of a medicament delivery assembly with a needle assembly
  • Figure 1B a perspective view of the medicament delivery device of the medicament delivery assembly of Fig. 1A;
  • Figure 2 the container housing of the medicament delivery assembly of Fig. 1A;
  • Figure 3 the medicament container of the medicament delivery assembly of Fig. 1A;
  • Figures 4 to 19 show various parts of the medicament delivery device of Figs. 1A, 1B;
  • Figure 4 the device body
  • Figure 5A a view onto a cross-section through the medicament delivery device of Figs. 1A, 1B;
  • FIG. 11 the activation slider (trigger element);
  • FIG. 12A the driver cap
  • Figure 12B the driver cap in a different view
  • Figure 13A the front dosing part (first dosing member);
  • FIG. 13B the rear dosing part (second dosing member);
  • Figure 14 the dose setting assembly comprising the first and second dosing members
  • FIG. 15A the locking device
  • Figure 15B a detail of the distal end of the locking device
  • Figure 16A a view onto a cross-section through the locking device assembled with the plunger rod
  • Figure 16B a cross-sectional view of the plunger rod assembled with several further parts of the medicament delivery device
  • Figure 17 a partial assembly of the medicament delivery device
  • Figure 18A shows a perspective view onto a detail of a cross-section through the medicament delivery device perpendicular to the device axis;
  • Figure 19 shows a perspective view onto a cross-section through a partial assembly of the medicament delivery device comprising the rear dosing part.
  • Fig. 1A shows a medicament delivery assembly 1 with a needle assembly 15 mounted which is shown partially transparent.
  • the medicament delivery assembly 1 comprises a container housing 4 in which a medicament container 3 is accommodated and a medicament delivery device 2 to which the container housing 4 can be mounted, as illustrated.
  • Fig. 1B shows the medicament delivery device 2.
  • container housing 4 is mounted to the medicament delivery device 2, more particularly to a device body 5 thereof (cf. Fig. 4)
  • container housing 4 and medicament container 3 are essentially immovable relative to the device body 5.
  • the medicament delivery device 2 and, more particularly, its plunger rod 7 (Fig. 6) or its plunger nut 8 (Fig. 7) defines a device axis A.
  • Fig. 2 shows the container housing 4 in more detail
  • Fig. 3 shows the medicament container 3, e.g., as known in the field, which comprises a vessel 35 containing a medicament 33, and a proximal closure comprising a septum 32 closing off the medicament container towards proximally which is to be pierced by a needle of the needle assembly 15 to expel portions of the medicament 33 therethrough.
  • Medicament container 3 also comprises a plunger 31 initially seated near its distal end, which closes off the medicament container 4 towards distally and which can be moved towards proximally in order to dispense the medicament 33 when a needle assembly 15 is mounted.
  • Container housing 4 (Fig. 2) has a seat for the medicament container 3 which is open towards distally and into which the medicament container 3 is insertable.
  • the proximal end of the container housing 4 has an outer thread 42 for mounting the needle assembly 15. Through housing windows 41, a user may see the medicament container 3 and can estimate how much of the medicament33 is left in it, with the assistance of dose indicators 43.
  • Figs. 4-19 illustrate the elements of the medicament delivery device 2.
  • Fig. 4 shows device body 5 which forms a portion of the housing of the medicament delivery device 2.
  • Fig. 5A shows a view onto a cross-section through the medicament delivery device 2.
  • Fig. 5B shows a view onto a cross-section of a front dosing part 61 assembled with the device body 5.
  • Fig. 6 shows the plunger rod 7 which is to be proximally moved to move the plunger 31 proximally to expel doses of the medicament 33.
  • Fig. 7 shows a plunger nut 8 to cooperate with plunger rod 7 to achieve the proximal movement.
  • Fig. 8 shows a drive spring 9 which is a pre-tensioned helical torsion spring to force plunger nut 8 to rotate for the expelling of a dose.
  • Figs. 12A, 12B show a driver cap 85 which is affixed to plunger nut 8, the two forming a driver assembly.
  • the driver assembly is rotatable but cannot move towards proximally, because its proximal end abuts the device body 5 (cf. the thick arrow in Fig. 5A).
  • Driver cap 85 cooperates with a dose setting assembly 6 (Fig. 14) comprising a front dosing part 61 (Fig. 13A) and a rear dosing part 62 (Fig. 13B).
  • the front dosing part 61 can also be referred to as first dosing member; and the rear dosing part can also be referred to as second dosing member or as dosing element.
  • a distal travel of rear dosing part 62 (relative to device body 5) is limited by cooperation of a flange-like circumferential ridge 62b and a corresponding abutting surface (not shown in the figures) in the interior of device body 5, e.g., a surface of a groove or of a ridge at the interior surface of device body 5. And it is rotatably mounted in device body 5 by ridge 62b, too.
  • the axial distance by which rear dose drum 62 can travel is limited by flange-like circumferential ridge 62b abutting said corresponding abutting surface of, e.g., said groove.
  • the circumferential ridge 62b can provide guidance for movements (axial and rotational) of the rear dosing part 62 relative to the device body 5.
  • Ridge 62b’ can also have one or both of the functions of flange-like circumferential ridge 62b, i.e. provide guidance for movements (especially a rotational mounting) and provide a limitation for movements of the rear dosing part 62 towards distally.
  • rear dosing part 62 is rotationally locked to front dosing part 61 and, at the same time, these two are axially moveable relative to one another.
  • rear dosing part 62 is in splined connection with front dosing part 62, as by cooperation of longitudinal splines 62c in the interior of rear dosing part 62 with longitudinal grooves 61c in the exterior of front dosing part 61.
  • rotating rear dosing part 62 causes a corresponding rotation of front dosing part 61.
  • the two parts are rotationally locked.
  • Front dosing part 61 (Figs. 13A, 14) has a generally tubular configuration, with helical features 61a close to its proximal end, to cooperate with interior threads 51 of device body 5 (Fig. 4).
  • Fig. 5B shows a view onto a crosssection of front dosing part 61 assembled with device body 5.
  • cw turning rear dosing part 62 results in cw turning of front dosing part 61 combined with a distal movement of front dosing part 61.
  • markings such as signs S (symbolically illustrated in Fig. 14), can be provided along a circumference of rear dosing part 62 which can be visible through a body window 52 of device body 5.
  • an indication of a set dosing amount can be provided by the markings.
  • rear dosing part 62 can be rotated and is rotated by more than 360°, the markings will repeat. Accordingly, they cannot correctly represent the set dosing amount in such cases. But if only rotations smaller than 360° are enabled, e.g., by implementation of a suitable stop structure in interior threads 51, the signs S can correctly correspond to (and indicate) set dosing amounts.
  • providing signs on the front dosing part 61 can reflect dosing amounts also beyond 360° (possibly beyond multiples of 360°) because of the distal movement of front dosing part 61 which is linked to the rotational (cw) movement of front dosing part 61.
  • a user can be informed about the set dosing amount also beyond 360° even without further signs such as the signs S on the rear dosing part 62; or, in another implementation, signs distributed along a longitudinal path on the exterior of front dosing part 61 can be used in a combined fashion together with signs S on the exterior of rear dosing part 62 to inform the user about the set dosing amount also beyond 360°.
  • the rear dosing part 62 can (and does) maintain its axial position, even if front dosing part 61 moves distally during dosing amount setting. Accordingly, it does not move distally further and further out of the device body 5 when increasing the set dosing amount.
  • the medicament delivery device 2 thus does not increase its length during dose setting.
  • the helical features 61a can be in an end position of the threads 51, in which no further ccw (counterclockwise) rotation is possible, but only cw rotation. Accordingly, after having set a dose (by cw rotation) and expelling that dose (ccw rotation), the threads 51 can provide a stop for the helical movement (rotation, combined with axial movement) of the front dosing part 61, thus providing a stop and a reference for the setting of the dosing amount. And it defines also the rotational (initial) position of the rear dosing part 62 in the initial state.
  • driver coupling 92 has spline grooves 92d cooperating with the longitudinal splines 62c.
  • Drive spring 9 is, at its proximal end, affixed to drive holder 91 and thus also to device body 5, as snap fit arms 9ie of drive holder 91 cooperate with snap fit openings 59 of device body 5. And at its distal end, drive spring 9 is affixed to driver coupling 92. Already in the initial state, drive spring 9 is pretensioned to force the dose setting assembly 6 to rotate in a ccw direction.
  • rear dosing part 62 forms a first ratchet structure Ri cooperating with a second ratchet structure R2 of the driver cap 85.
  • Driver cap 85 is affixed to plunger nut 8 by a snap fit connection, as snap fit arms 85c of driver cap 85 cooperate with snap fit openings 8e of plunger nut 8.
  • first ratchet structure Ri could also be a separate part which however is affixed to rear dosing part 62.
  • the first ratchet structure Ri comprises a plurality of ratchet teeth 8sr, e.g., an array of ratchet teeth 8sd, each having a stop surface Ris and an inclined surface Rii.
  • the second ratchet structure R2 comprises a plurality of ratchet teeth 62d, e.g., an array of ratchet teeth 62d, each having a stop surface and an inclined surface.
  • the teeth 62d, 8sd are generally radially aligned. And they axially protrude from respective surfaces which are aligned perpendicularly to the device axis A. However, the teeth 62d, 8sd could also protrude from conical surfaces, a convex conical surface facing a corresponding concave conical surface.
  • the teeth 62d and 82d cooperate to facilitate a cw rotation of the rear dosing part 62 relative to the driver cap 85, namely by the respective inclined surfaces sliding along one another and thus causing a slight distal movement of the rear dosing part 62 and letting the teeth 62d pass over the teeth 8sd; and a ccw rotation of the rear dosing part 62 relative to the driver cap 85 is inhibited by an abutting of the stop surfaces - unless further measures are taken, as described below.
  • a user can set a dosing amount by cw turning the read dosing part 62, whereas - unless said further measures are made use of - he/she cannot turn the read dosing part 62 in a ccw direction for achieving a reduction of the set dosing amount.
  • Fig. 18A shows a perspective view onto a detail of a cross-section through the medicament delivery device 2 perpendicular to the device axis A, approximately at the position indicated by the thick dashed lines in Fig. 18.
  • the first and second ratchet structures Ri, R2 are present on surfaces aligned perpendicularly to the device axis A.
  • the teeth 62d protrude towards proximally from a proximally facing surface of rear dosing part 62, and the teeth 82d protrude towards distally from a distally facing surface of driver cap 85.
  • teeth 62d could protrude towards distally from a distally facing surface of rear dosing part 62, and the teeth 82d could protrude towards proximally from a proximally facing surface of driver cap 85.
  • the surfaces could be conical surfaces, as mentioned above already.
  • Rear dosing part 62 is proximally biased. A force exerted by user is required to cause a moving of rear dosing part 62 towards distally.
  • the proximal bias is caused by means of a setting spring 69 which can be integrally formed with rear dosing part 62, cooperating with a stop-forming feature affixed to the device body 7, such as with a flange-like circumferential ridge protruding inwardly from an interior surface of device body 5 (not shown in the figures).
  • Setting spring 69 can be an elastic bar affixed at its ends and describing an arc having an apex towards distally, as illustrated (Fig. 14).
  • other ways of producing the proximal bias on rear dosing part 62 are possible, e.g., based on a flexible bar at the device body 5 or based on a separate spring.
  • the setting spring 69 not only enables the setting of a dose by enabling the slight distal movement of the rear dosing part 62 required for operating the ratchet mechanism (letting the teeth 62d pass over the teeth 8sd) when cw turning the rear dosing part 62. But further enables a user to disengage the ratchet mechanism (and thus to override the ratchet mechanism) by pulling the rear dosing part 62 towards distally, counteracting the bias of setting spring 69.
  • the user can correct a setting made just before (former setting); the medicament delivery device 2 and the dose setting mechanism, respectively, can be considered in a correction state then.
  • the user can selectively turn the rear dose part 62 ccw to reduce the former setting or turn the rear dose part 62 cw to further increase the former setting.
  • the user can correct a setting he/she made.
  • the user would press the rear dosing part 62 towards proximally in order to disengage the ratchet mechanism for changing (correcting) a setting.
  • the user would either pull or press the rear dosing part 62 to disengage the ratchet mechanism for changing a setting, depending on whether the conical surface of the first ratchet part faces partially towards proximally or partially towards distally.
  • the driver coupling 92 When disengaging the ratchet mechanism, the driver coupling 92 continues to be rotationally locked to rear dosing part 62, as does the front dosing part 61, and thus, the user can freely select, by rotating the rear dosing part 62 whether to increase the dose setting (and to which extent) or to reduce the dose setting (and to which extent), wherein the reduction to zero is possible, but not below zero, because when a reduction to zero is selected (by the ccw rotation), the helical features 61a are in an end position of the threads 51, in which no further ccw rotation is possible; the helical features 61a abut a stop at the end of the threads 51.
  • Activation slider 13 is mounted to device body 5 in a longitudinally slidable way: A protrusion 13a cooperates with a guiding slit in device body 5 (not shown); and guiding features 13b cooperating (i) with cooperating slit rims 46 of container housing 4 and (ii) with features 56 of device body 5. Activation slider 13 is mounted to device body 5 in a rotationally locked way.
  • Plunger nut 8 has an interior thread 82 (plunger nut thread) cooperating with an exterior thread 72 (plunger rod thread) of plunger rod 7.
  • the two threads 72, 82 are engaged with one another, so that a ccw rotation of plunger nut 8 causes a proximal movement of plunger rod 7.
  • plunger nut 8 Towards its proximal end, plunger nut 8 is rotatably supported by an interior bore 91a of driver holder 91, and towards its distal end, plunger nut 8 is rotatably supported by an interior bore 92a of driver coupling 91.
  • Device body 5 has a plunger rod guiding portion 54 comprising an opening through which plunger rod 7 extends.
  • the plunger rod guiding portion 54 comprises two guiding protrusions 57 which rotationally lock plunger rod 7 by cooperating with two longitudinal guiding faces 75 of plunger rod 7.
  • plunger rod 7 is moved towards proximally, as driven by the ccw rotation of plunger nut 8 which is driven by drive spring 9. And this ccw rotation is carried out, too, by the distal end of drive spring 9, by driver coupling 92, by driver cap 5, by rear dosing part 62 and by front dosing part 61, wherein the latter also stops the ccw rotation (as described above, in the end position) and thus determines the end of the expelling.
  • the medicament delivery device 2 not only has the described dose setting mechanism but has furthermore a device termination mechanism which can also be referred to as end lock mechanism.
  • the described dose setting mechanism can also be implemented without the device termination mechanism.
  • the device termination mechanism can also be implemented with a different dose setting mechanism, e.g., with a dose setting mechanism which does not allow corrections of a set dosing amount, at least for corrections which shall decrease the set dosing amount.
  • the device termination mechanism can be implemented with a dose setting mechanism corresponding with the described one, but without the correction possibility and/or with merely a single dose setting part (e.g., as if the front and rear dosing parts were one and the same or completely locked to one another).
  • the device termination mechanism ensures that the medicament delivery device 2 is locked after the plunger rod 7 has proximally moved a predetermined maximum length.
  • the device termination mechanism shall ensure that the device 2 is locked when a predetermined maximum amount of the medicament 33 has been expelled from the medicament container 3 and, accordingly, when only a predetermined minimum amount (threshold amount) of the medicament 33 still remains in the medicament container 3, respectively.
  • the ratchet mechanism is locked in the engaged position. This is accomplished by means of locking device 10 interacting on the one hand with plunger rod 7 and on the other hand, with both, the driver cap 85 and the rear dosing part 62. Furthermore, medicament delivery device 2 is locked in that a further movement towards proximally of plunger rod 7 is inhibited.
  • Exemplary drugs that could be included in the delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the “innovator” or “branded” version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab- afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.
  • Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, loo U/mL Heparin Lock Flush Solution,

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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

Le dispositif d'administration de médicament (2) comprend un ensemble de base auquel un récipient de médicament (3) peut être monté et un dispositif de tige de piston (7) mobile axialement pour agir, dans un mouvement d'expulsion vers de manière proximale, sur un piston (31) du récipient de médicament (3) pour expulser le médicament. Il comprend également un élément de sollicitation d'entraînement (9) et un ensemble d'entraînement sollicité par l'élément de sollicitation d'entraînement (9) et couplé au dispositif de tige de piston (7), configuré pour transporter un mouvement d'entraînement provoquant le mouvement d'expulsion. De plus, un mécanisme de réglage de dose pour régler et corriger une quantité de dosage est fourni qui comprend - un premier élément de dosage (61) et un second élément de dosage (62) qui sont couplés en rotation et axialement mobiles l'un par rapport à l'autre, un angle de rotation supposé par le premier élément de dosage (61) déterminant la quantité de dosage - un mécanisme à cliquet avec une première structure à cliquet verrouillée en rotation sur l'ensemble d'entraînement et une seconde structure à cliquet verrouillée en rotation sur le second élément de dosage (62), qui, dans un état de réglage, sont en prise l'une avec l'autre et qui, dans un état de correction, sont dégagées l'une de l'autre, et qui, dans l'état de réglage, o permettent une rotation de la seconde structure à cliquet (R2) par rapport à la première structure à cliquet dans un premier sens de rotation ; et o inhibent une rotation de la seconde structure à cliquet (R2) par rapport à la première structure à cliquet (R1) dans un second sens de rotation opposé au premier sens de rotation.
PCT/EP2025/055621 2024-03-18 2025-03-03 Dispositif d'administration de médicament et ensemble d'administration de médicament Pending WO2025195750A1 (fr)

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EP24164211 2024-03-18

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090054839A1 (en) * 2004-10-21 2009-02-26 Novo Nordisk A/S Injection device with torsion spring and rotatable display
US20100186739A1 (en) * 2005-06-01 2010-07-29 Victor Kronestedt Device for Delivering Medicament
US20110034881A1 (en) * 2008-02-12 2011-02-10 Shl Group Ab Auto-Injector
US20130204193A1 (en) * 2010-04-19 2013-08-08 Shl Group Ab Self-Administration Medicament Delivery Device
US20130245558A1 (en) * 2010-11-18 2013-09-19 Shl Group Ab Medicament Delivery Device
WO2016135237A1 (fr) 2015-02-27 2016-09-01 Novo Nordisk A/S Dispositif d'administration de médicament avec mécanisme de réinitialisation de dose

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090054839A1 (en) * 2004-10-21 2009-02-26 Novo Nordisk A/S Injection device with torsion spring and rotatable display
US20100186739A1 (en) * 2005-06-01 2010-07-29 Victor Kronestedt Device for Delivering Medicament
US20110034881A1 (en) * 2008-02-12 2011-02-10 Shl Group Ab Auto-Injector
US20130204193A1 (en) * 2010-04-19 2013-08-08 Shl Group Ab Self-Administration Medicament Delivery Device
US20130245558A1 (en) * 2010-11-18 2013-09-19 Shl Group Ab Medicament Delivery Device
WO2016135237A1 (fr) 2015-02-27 2016-09-01 Novo Nordisk A/S Dispositif d'administration de médicament avec mécanisme de réinitialisation de dose

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