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WO2025146393A1 - Dispositif de délivrance de médicament et ensemble de délivrance de médicament - Google Patents

Dispositif de délivrance de médicament et ensemble de délivrance de médicament Download PDF

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Publication number
WO2025146393A1
WO2025146393A1 PCT/EP2024/088168 EP2024088168W WO2025146393A1 WO 2025146393 A1 WO2025146393 A1 WO 2025146393A1 EP 2024088168 W EP2024088168 W EP 2024088168W WO 2025146393 A1 WO2025146393 A1 WO 2025146393A1
Authority
WO
WIPO (PCT)
Prior art keywords
medicament delivery
dosing
rotation
engaging structures
plunger rod
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/EP2024/088168
Other languages
English (en)
Inventor
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 WO2025146393A1 publication Critical patent/WO2025146393A1/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
    • A61M5/24—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—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
    • A61M5/31581—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 rotationally moving or pivoting actuator operated by user, e.g. an injection lever or handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—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

Definitions

  • the invention is in the field of medicament delivery devices.
  • it relates to automatic medicament delivery devices and to medicament delivery devices for delivering multiple fixed doses of a medicament.
  • Such medicament delivery devices and medicament delivery assemblies should generally be safe to use and easy to handle, and they should ensure delivery of the designated dose of the medicament with high accuracy.
  • Such multi-dose medicament delivery devices cannot depend on the filling equipment for dosing accuracy and are instead relying on the device design, i.e., the medicament delivery device has to comply with corresponding regulations such as ISO requirements for dose accuracy.
  • the medicament delivery device has to comprise a mechanism for reliably delivering accurate medicament doses.
  • the dosing amount should be dependent on as few components as possible to minimize the risk of tolerance stack-up possibly causing an under- or overdose. Manufacturing tolerances need to be low, and long links of assembled parts need to be avoided.
  • Another object of the invention is to create a medicament delivery device which is particularly environment-friendly and/or has a small carbon footprint.
  • the medicament delivery device should be advantageous in terms of safety, reliability, ease of use. Further objects and various advantages emerge from the description and embodiments below.
  • the medicament delivery device defines a device axis, more particularly a proximodistal axis, and comprises a plunger rod device comprising at least one cooperation element, e.g., a protrusion, and being axially movable; a biasing device, e.g., a spring, configured to force the plunger rod device in a proximal direction; a dosing device for controlling a dosing amount for each of the doses.
  • a plunger rod device comprising at least one cooperation element, e.g., a protrusion, and being axially movable
  • a biasing device e.g., a spring
  • the plunger rod device can be cooperating with a stopper device of the medicament container.
  • Such a multi-dose fixed-dose medicament delivery device can enable to successively expel accurate pre-determined dosing amounts from a single medicament container.
  • the dosing device can provide stops for inhibiting proximal movement of the plunger rod device which come into effect at different rotational positions (of the dosing device relative to the plunger rod device, more particularly to at least one cooperation element), such that the plunger rod device can move (forced by the biasing device), in reaction to a rotation (from a first to a second such rotational position), from an initial axial position taken at the beginning of a delivery of a dose to a final axial position taken at the end of a delivery of the respective dose.
  • the plunger rod device can thus cooperate with a stopper device of the medicament container so as to proximally move the stopper device from an initial position (at the beginning of a delivery) to a final position (at the end of a delivery).
  • the plunger rod device can abut the stopper device in its initial axial position and in its final axial position.
  • the dosing amount can be defined by the axial distance between the initial position and the final position of the stopper device which again can be defined by the axial distance between the initial axial position and the final axial position of the plunger rod device.
  • Said axial movement is also sometimes referred to as axial stroke and can define the respective dosing amount of the respective dose.
  • an axial movement (of the clutch device) can be used to activate the medicament delivery device.
  • a user can operate an activation button by pressing, and a corresponding axial movement, e.g., proximal movement, of the activation button can be coupled to the clutch device which, accordingly, moves proximally then.
  • the rotation of the dosing device can be derived from the proximal movement of the clutch device by the cooperation of the first engaging structures with the engaging structures of the dosing device.
  • medicament delivery device 2 comprises an alignment member 14 and a clutch device 9 which cooperates with alignment member 14 and dosing device 8 to effect a step-wise rotation of dosing device 8.
  • the cooperation elements 61 have abutting surfaces 61 which, at the beginning of the expelling of a dose, are in contact with a first retaining structure 81a, more precisely with an abutting surface constituted by first retaining structure 81a (first abutting surface), and which, at the end of the expelling of the dose, are in contact with a second retaining structure 81b, more precisely with an abutting surface constituted by second retaining structure 81b (second abutting surface).
  • a start position of the proximal movement of plunger rod device 6 for the expelling of a dose is well- defined (first spring 7 forcing plunger rod device 6 proximally, the proximal movement being blocked by the first retaining structure 81a); and an end position of the proximal movement of plunger rod device 6 for the expelling of a dose is well-defined (first spring 7 forcing plunger rod device 6 proximally, the proximal movement being blocked by the second retaining structure 81b).
  • the proximal stroke of plunger rod device 6 is thus defined and predetermined by an axial distance of the respective first retaining structure 81a and second retaining structure 81b; in the illustrated embodiment, said distance is even identical to said proximal stroke, but however can be different in other embodiments.
  • said axial distance is illustrated by a double arrow.
  • a corresponding pair of retaining structures is provided for each of the doses.
  • two such pairs (retaining structures 81a, 81b and retaining structures 82a, 82b) are shown.
  • there are even two such pairs for each of the doses one for cooperating with a first one of the cooperation elements 61 and another one for cooperating with the other one of the cooperation elements 61.
  • a first retaining structure 81a of a pair can be identical to a second retaining structure 82b of another pair.
  • a final axial position of the plunger rod device for one dose (defined by retaining structure 81b) can be identical to an initial axial position of the plunger rod device for another dose, in particular for the next dose (defined by retaining structure 82a).
  • other implementations are possible.
  • dosing device 8 forms a tubular body, however other implementations are possible.
  • the retaining structures form a shelf structure, however other implementations are possible.
  • dosing device 8 is suitably rotated and to the operation of the medicament delivery device 2.
  • Alignment member 14 is fixed to distal housing part 4b, e.g., like in the illustrated embodiment, by means of a snap fit connection provided by opening 41 and part 14a (cf. Fig. 2). Thus, alignment member 14 neither rotates nor translates relative to housing 4.
  • Clutch device 9 is locked to activation button 10, such that their axial movements (proximally and distally) are fixedly coupled to one another, e.g., like in the illustrated embodiment, by means of two snap fit connections, such as provided by protrusions 9a of clutch device 9 cooperating with openings 10b of activation button 10 on the one hand and by protrusions 10a of activation button 10 cooperating with opening 9b of clutch device 9 on the other hand; cf. Figs. 6A, 6B, 6C. Clutch device 9 and activation button 10 could alternatively be embodied as a unitary part or be integrally formed - if assembly of the medicament delivery device 2 is then still possible.
  • a rotation (about axis A) of clutch device 9 in a (second) sense of rotation, such as ccw (counterclockwise), is blocked, e.g., as illustrated, by blocking elements 9c of clutch device 9 (cf. Figs. 6B, 6C) cooperating with blocking elements 42, e.g., ribs, of housing 40 (more particular of proximal housing part 4a), cf.
  • Clutch device 9 comprises first engaging structures 91 cooperating with engaging structures 83 of dosing device 8, and further comprises second engaging structures 92 cooperating with engaging structures 141 of alignment member 14.
  • both, clutch device 9 and dosing device 8 are rotatable (about axis A).
  • the cooperation between engaging structures 141 and engaging structures 92 enables to derive a rotation of clutch device 9 from a translation of clutch device 9 (at least when these engaging structure are not in line).
  • the cooperation between engaging structures 83 and engaging structures 91 enables to effect (i) a rotation (cw; clockwise) of dosing device 8 from a translation (proximally) of clutch device 9, and (ii) a rotation of clutch device 9 (cw) from a rotation of dosing device 8 (cw).
  • Activation of the medicament delivery device 2 requires two steps.
  • clutch device 9 is re-positioned (rotation-wise) with respect to dosing device 8, and at the same time, activation button 10 is released, i.e. is distally moved, by the force exerted by second spring 11, from a first position (inner position; Figs. 9A, 9D) to a second position (outer position; Fig. 9C).
  • activation button 10 When then activation dial 12 is released (and allowed to return into its rest position), a further distal movement of activation button 10 is not blocked anymore (not blocked anymore by cooperation of protrusions 10c and blocking structures 12b), and activation button 10 can move distally to reach said second position (outer position; Fig. 9C) in which it is ready to be operated (pressed) again, so as to be ready for the second activation step.
  • the distal movement of activation button 10 will effect a corresponding distal movement of clutch device 9.
  • clutch device 9, more particularly its first engaging structures 91 are engaged with engaging structures 83 of dosing device 8.
  • clutch device 9, more particularly its second engaging structures 92 By said corresponding distal movement of clutch device 9, clutch device 9, more particularly its second engaging structures 92, are brought into contact with (and are engaged with) engaging structures 141 of alignment member 14. And first engaging structures 91 and engaging structures 83 are disengaged.
  • the engaging structures (83, 91, 92, 141) comprise steep sections, which in particular can be aligned parallel to axis A, and inclined sections, as is exemplarily shown in Fig. 6B for engaging structures 92 of clutch device 9, indicating inclined sections 92a and steep sections 92b; cf. also inclined sections 91a and steep sections 91b in Fig. 6C.
  • the user operates, more particularly presses, activation button 10, thus proximally moving clutch device 9, which again effects that clutch device 9 and dosing device 8 engage (with their respective engaging elements 91, 83); and engaging elements 92 and 141 disengage.
  • a cw rotation of dosing device 8 is this way effected (as will be described below; ccw rotation of clutch device 9 is prevented, cf.
  • moving dosing device 8 out of a first rotational position, which again effects that plunger rod device 6 is not anymore blocked from moving proximally by a respective first retaining structure, such that first spring 7 can move plunger rod device 6 proximally, such that a respective fixed dose is expelled, wherein expelling the dose ends when plunger rod device 6 is blocked from moving further proximally by a respective second retaining structure; as described above.
  • Figs. 9A to 9D show the medicament delivery device 2 in different states, wherein some parts of medicament delivery device 2 are not shown, such as housing 4.
  • Fig. 9A illustrates the situation at the beginning of the first activation step (activation button 10 in the first (inner) position; activation dial 12 in the rest position).
  • Fig. 9B illustrates the situation during the first activation step, with activation button 10 in the intermediate position, and with activation dial 12 in the deflected position.
  • Fig. 9C illustrates the situation at the end of the first activation step, with activation button 10 in the second (outer) position, and with activation dial 12 again in the rest position.
  • Fig. 9D illustrates the situation at the end of the second activation step, with activation button 10 again in the first (inner) position, and with activation dial 12 still in the rest position.
  • This situation can correspond to the situation illustrated in Fig. 9A, but for the next dose.
  • a mechanism should be present which effects this, i.e., a mechanism which rotates clutch device 9, e.g., further cw, after clutch device 9 has disengaged from alignment member 14 and before it re-engages alignment member 14 at the end of the first activation step.
  • Various mechanisms can be used to accomplish this.
  • a particular elegant mechanism is implemented. This mechanism involves inclined portions 84 of the retaining structures, cf. Fig. 4. One can say it creates an “over-rotation” of dosing device 8.
  • dosing device 8 When engaging structures 91 have engaged engaging structures 83 and effected the corresponding cw rotation of dosing device 8 provided by the interaction of clutch device 9 and dosing device 8, dosing device 8 will move out of the first rotational position towards a second rotational position and let plunger rod device 6 movement proximally (dosing device 8 discontinues blocking of the proximal movement). However, during this, cooperation elements 61 of plunger rod device 6 (biased by first spring 7) will effect an additional cw rotation of dosing device 8, namely when they cooperate with the inclined portions 84 of dosing device 8, as dosing device 8 is rotatable, whereas plunger rod device 6 is not.
  • the medicament delivery device can as well be embodied with the senses of rotation (cw; ccw) inverted (to ccw; cw). Besides, embodiments with merely cw rotations are possible, and embodiments with merely ccw rotations are possible too.
  • the illustrated medicament delivery device 2 (and medicament delivery device assembly 1) is suitable for multi-dose, fixed-dose injection in a safe way, such that medically trained personnel and also not specifically medically trained people such as a patient himself / herself can apply it, as an autoinjector.
  • the plunger rod device e.g., an abutting surface of a plunger rod of the plunger rod device
  • the plunger rod device can be operating a stopper device of the medicament container continuously from the beginning of the delivery of the first dose until the end of the delivery of the last dose. No mechanical play (or, at most, a negligible mechanical play) is present during that between the plunger rod device and the stopper device.
  • the medicament delivery device can be operated without a need for priming after start of the delivery of the first dose.
  • Dosing amounts can be delivered with high accuracy.
  • the delivery devices described herein can be used for the treatment and/or prophylaxis of one or more of many different types of disorders.
  • Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia and/or dyslipidemia, cardiovascular disease, diabetes (e.g.
  • 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, 100 U/mL Heparin Lock Flush Solution, or

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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 de délivrance de médicament pour recevoir un contenant de médicament contenant un médicament et pour expulser de multiples doses du médicament à partir du contenant de médicament définit un axe de dispositif et comprend - un dispositif de tige de piston (6) comprenant au moins un élément de coopération (61) et étant axialement mobile ; - un dispositif de sollicitation (7) configuré pour forcer le dispositif de tige de piston (6) dans une direction proximale ; - un dispositif de dosage (8) pour contrôler une quantité de dosage pour chacune des doses. Le dispositif de dosage (8) comprend de multiples structures de retenue (81a, 81b, 82a, 82b) configurées pour coopérer avec l'élément ou les éléments de coopération (61) pour bloquer un mouvement proximal du dispositif de tige de piston (6). Pour chacune des doses les éléments suivants s'appliquent : - les structures de retenue (81a, 81b, 82a, 82b) comprennent un ensemble respectif comprenant une première structure de retenue (81a, 82a) respective et une seconde structure de retenue (81b, 82b) respective ; - le dispositif de dosage (8) peut tourner par rapport au dispositif de tige de piston (6) d'une première position de rotation respective à une seconde position de rotation respective, dans la première position de rotation respective, un mouvement proximal du dispositif de tige de piston (6) est bloqué par coopération de l'élément ou des éléments de coopération (61) avec la première structure de retenue (81a, 82a) respective, et dans la seconde position de rotation respective, un mouvement proximal du dispositif de tige de piston (6) est bloqué par coopération de l'élément ou des éléments de coopération (61) avec la seconde structure de retenue (81b, 82b) respective ; - une distance axiale entre la première structure de retenue (81a, 82a) respective et la seconde structure de retenue (81b, 82b) respective définit un mouvement axial respectif du dispositif de tige de piston (6).
PCT/EP2024/088168 2024-01-03 2024-12-20 Dispositif de délivrance de médicament et ensemble de délivrance de médicament Pending WO2025146393A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP24150239 2024-01-03
EP24150239.2 2024-01-03

Publications (1)

Publication Number Publication Date
WO2025146393A1 true WO2025146393A1 (fr) 2025-07-10

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Application Number Title Priority Date Filing Date
PCT/EP2024/088168 Pending WO2025146393A1 (fr) 2024-01-03 2024-12-20 Dispositif de délivrance de médicament et ensemble de délivrance de médicament

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100036320A1 (en) * 2008-08-05 2010-02-11 Cox Janice L Multiple dosage injector
US20170348487A1 (en) * 2011-09-09 2017-12-07 Merck Patent Gmbh Auto-injector for epinephrine injection
US20180050159A1 (en) * 2015-03-05 2018-02-22 Carebay Europe Ltd Medicament delivery device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100036320A1 (en) * 2008-08-05 2010-02-11 Cox Janice L Multiple dosage injector
US20170348487A1 (en) * 2011-09-09 2017-12-07 Merck Patent Gmbh Auto-injector for epinephrine injection
US20180050159A1 (en) * 2015-03-05 2018-02-22 Carebay Europe Ltd Medicament delivery device

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