WO2014111370A1 - Medicament delivery device - Google Patents

Medicament delivery device Download PDF

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Publication number
WO2014111370A1
WO2014111370A1 PCT/EP2014/050569 EP2014050569W WO2014111370A1 WO 2014111370 A1 WO2014111370 A1 WO 2014111370A1 EP 2014050569 W EP2014050569 W EP 2014050569W WO 2014111370 A1 WO2014111370 A1 WO 2014111370A1
Authority
WO
WIPO (PCT)
Prior art keywords
drive
spring force
drive member
medicament delivery
delivery device
Prior art date
Application number
PCT/EP2014/050569
Other languages
French (fr)
Inventor
Johan Egerström
Marcus Söderlund
Nils Ronquist
Original Assignee
Carebay Europe Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Carebay Europe Ltd filed Critical Carebay Europe Ltd
Priority to US14/760,865 priority Critical patent/US20150352298A1/en
Priority to CA2897350A priority patent/CA2897350A1/en
Priority to CN201480007685.0A priority patent/CN104994896A/en
Priority to EP14701927.7A priority patent/EP2945666B1/en
Priority to DK14701927T priority patent/DK2945666T3/en
Publication of WO2014111370A1 publication Critical patent/WO2014111370A1/en

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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
    • A61M11/007—Syringe-type or piston-type sprayers or atomisers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • 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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/06—Sprayers or atomisers specially adapted for therapeutic purposes of the injector type
    • 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
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • 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
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • A61M15/0025—Mouthpieces therefor with caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • 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
    • A61M15/00—Inhalators
    • A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • 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
    • A61M15/00—Inhalators
    • A61M15/0091—Inhalators mechanically breath-triggered
    • A61M15/0096—Hindering inhalation before activation of the dispenser
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • 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
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • 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
    • A61M5/3146—Priming, e.g. purging, reducing backlash or clearance
    • 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
    • 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
    • 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
    • A61M5/31543—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change
    • 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
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3156—Mechanically operated dose setting member using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/02—Membranes or pistons acting on the contents inside the container, e.g. follower pistons
    • B05B11/025—Membranes or pistons acting on the contents inside the container, e.g. follower pistons with stepwise advancement of the piston, e.g. for spraying a predetermined quantity of content
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F11/00—Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it
    • G01F11/02—Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers which expand or contract during measurement
    • G01F11/021—Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers which expand or contract during measurement of the piston type
    • G01F11/025—Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers which expand or contract during measurement of the piston type with manually operated pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401—Functional features
    • A61M2005/1402—Priming
    • 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
    • A61M2005/2006—Having specific accessories
    • A61M2005/202—Having specific accessories cocking means, e.g. to bias the main drive spring of an injector
    • 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
    • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A—HUMAN NECESSITIES
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    • 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
    • A61M5/31536—Blocking means to immobilize a selected dose, e.g. to administer equal doses
    • A61M2005/3154—Blocking means to immobilize a selected dose, e.g. to administer equal doses limiting maximum permissible dose
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    • A61M2205/00—General characteristics of the apparatus
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    • A61M2210/00—Anatomical parts of the body
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    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0625—Mouth

Definitions

  • the present invention relates to a medicament delivery device and in particular a device capable of delivering a number of predetermined metered doses.
  • the disclosed device comprises a plunger rod, which, when driven by a pre-tensioned helical spring, forces a stopper into a cartridge containing medicament, whereby a dose of medicament is delivered from an administration member.
  • the administration member could be a mouth piece or a nasal piece.
  • a drawback with the device of WO 201 1/043712 is that there is no indication that a dose has been set and that the device is ready for dose delivery. This may be a drawback where the device user either is not very used to handling the device so that he/she is uncertain that the device has been handled properly for making it ready for dose delivery. Also for experienced users, it is advantageous to be provided with a positive indication that the handling steps prior to dose delivery have been performed correctly.
  • liquid encompasses all solutions, suspensions, emulsions, oils, gels and so forth, which generally behave as liquids at operating temperatures.
  • the term explicitly includes solid compositions dissolved or dispersed in a liquid carrier. Materials behaving as highly viscous liquids are also included.
  • distal part/end refers to the part/end of the medical delivery device, or the parts/ends of the members thereof, which during use of the device is located the furthest away from the delivery site of the patient.
  • proximal part/end refers to the part/end of the device, or the parts/ends of the members thereof, which under use of the device is located closest to the delivery site of the patient.
  • the aim of the present invention is to remedy the drawbacks of the state of the art devices. This is obtained by a medicament delivery device according to the features of the independent patent claim 1. Preferable embodiments of the invention form the subject of the dependent patent claims.
  • the present invention pertains to a medicament delivery device for delivering metered doses of medicament. It comprises preferably at least one generally elongated tubular chassis, the chassis having opposite distal and proximal ends.
  • a threaded plunger rod may be arranged inside said chassis.
  • the plunger rod is arranged to cooperate with a drive nut, which is threadedly connected to the threaded plunger rod.
  • the device may further preferably be provided with a drive member.
  • This drive member is preferably rotatably connected to a spring force tensioning member.
  • the spring force tensioning member is accessible outside the distal end of the chassis. It is however to be understood that the spring force tensioning member may be placed on other locations on the chassis.
  • the drive member is preferably connected to the drive nut via an drive member extension such that said drive member extension and said drive member are operably interconnected for providing a rotational lock of the drive member extension in an opposite direction when said drive member is rotated by said spring force tensioning member.
  • the drive member extension and said drive nut may be operably interconnected for providing a rotational lock of the drive nut in relation to the drive member extension.
  • the device is further arranged with spring force member, that in one preferred embodiment is in the form of a spiral spring. It is however to be understood that other types of spring force member may be used for the same function.
  • the spring force member has a first end connected to the drive member and a second end connected to a fixed point on the chassis such that said spring force member is tensioned when said spring force tensioning member and said drive member are rotated.
  • a guide nut may be arranged with guide ledges which may cooperate with longitudinal grooves of the plunger rod for providing a rotational lock but allowing a longitudinal movement of the plunger rod in relation to the guide nut.
  • a manually operated activation means is releasably interconnected to said drive member extension by engagement means for providing a rotational locking of the drive member extension in any direction when said drive member is rotated and said spring force member is tensioned by handling said spring force tensioning member for setting the device ready for delivery of a dose of medicament.
  • an indicator mechanism operably connected to said drive member and arranged to visibly indicate to a user of the device when said spring force tensioning member has been operated such that the device is ready for dose delivery.
  • the user is informed by the indicator mechanism when the spring force tensioning member has been operated to an extent that the device is ready for use.
  • the user is thus provided with positive information and can be assured that when the indication is visible, the device is ready for dose delivery.
  • the indicator mechanism may comprise a surface operably connected to said drive member, which surface is arranged with a noticeable indication member, the indicator mechanism further comprising an opening in said chassis for viewing said surface.
  • the surface may be operably arranged at said drive member such that said indication member is visible in said opening when said spring force tensioning member has been operated, i.e. showing that the device is ready for dose delivery.
  • the indicator becomes visible only when the spring force tensioning member, and thus the drive member, has been turned such that a dose has been set and the device is ready for dose delivery.
  • the indication member comprises a distinct colour.
  • This colour may for example be a clear green colour, indicating a ready device in a positive way.
  • the colour may be chosen such that it is a clear alert, such as orange, yellow, possibly also fluorescent.
  • the indication member may comprise indicia.
  • the indicia could for example be a check mark, letters, words like "OK", a graphic symbol or the like, just to mention a few.
  • the opening may be arranged with a magnifying lens or the like, where the indication member is even more clearly visible.
  • the medicament delivery device is an inhalation device, an eye spray device or an injector.
  • FIG. 1 is a perspective view of a medicament delivery device comprising the present invention
  • Fig. 2 is an exploded view of the proximal part of Fig. 1
  • Fig 3 is a cross-sectional view of the proximal part of Fig. 2
  • Fig 4 is a detailed view of a distal area of the proximal part of Fig. 2
  • Fig 5 is a perspective view of a distal area of the proximal part of Fig. 2
  • Fig 6 is a perspective view of a distal part of the device of Fig. 1
  • Fig 7 is an exploded view of the distal part of Fig. 6
  • Fig 8 is a cross-sectional view of the distal part of Fig. 6
  • Figs. 9-16 are detailed views of components comprised in the distal part of Fig. 6,
  • Figs. 17-18 are detailed views showing different functional states. DETAILED DESCRIPTION OF THE INVENTION
  • One embodiment of a device shown in the drawings comprises a generally elongated body 10.
  • the body 10 is in the embodiment shown divided into two parts; a proximal part 12 and a distal part 14, Fig. 1.
  • the proximal part 12 comprises generally tubular housing part 16, Fig. 2.
  • a proximal end of the housing part 16 is arranged with an attachment area 18, Fig. 2, onto which a medicament delivery member 20 can be releasably attached.
  • the attachment means between the medicament delivery member 20 and the housing 16 could for example be ledges 22 that snap into corresponding grooves 23, Fig. 3. It is however to be understood that other types of attachment means could be utilized.
  • the medicament delivery member 20 is in the embodiment shown a mouthpiece through which a user inhales when a dose of medicament is to be delivered. It is however to be understood that other types of medicament delivery members could be used, such as nasal pieces, eye pieces and even injection needles and the like.
  • the proximal part 12 is further arranged with a generally elongated tubular
  • the medicament container holder 24 is arranged with generally radially flexing legs 28, Fig. 3, with outwardly extending ledges 30 that fit into recesses 32 in the housing part 16.
  • the medicament container 26 is in the embodiment shown arranged with a proximal neck 34 and a movable stopper 36 inside the container.
  • a nebulizing nozzle 38 is arranged, Figs. 2 and 3.
  • the nebulizing nozzle 38 contains a chip (not shown) with a plurality of micro channels capable of creating an aerosol of droplets of medicament.
  • a medicament container guide member 40 is arranged with a central passage and is intended to be pushed onto the medicament container 26 from its proximal end and into contact with an annular ledge 42 (Fig. 4) at a distal end of the medicament container 26, Fig. 2.
  • the medicament container guide member 40 is arranged with a number of proximally extending arms 44, Fig. 3, arranged generally radially flexible and having outwardly extending protrusions 46. These protrusions 46 are arranged to grip around an annular ledge 48 of the housing for locking the medicament container guide member 40 and thus the medicament container 26 in the radial direction.
  • a medicament holder locking member 50 is arranged to be pushed into the distal end of the medicament container holder 24, and moved in contact with a distally directed end surface of the medicament container 24.
  • the medicament holder locking member 50 is arranged with a central passage 52 and is provided with a number of generally radially flexible tongues 54 having outwardly extending protrusions 56, Fig. 4. These protrusions 56 are arranged to fit into recesses 58 on inner surfaces of the medicament container guide member 40 such that when the medicament holder locking member 50 is in place, the medicament container 26 is locked in the axial direction.
  • the distal part 14 is arranged with a housing. In the embodiment shown the housing is designed as two housing halves 60, 62, Fig. 6. It is however to be understood that the housing may be arranged in other ways and in more parts without departing from the scope of the invention.
  • a generally tubular chassis 64 is arranged, Figs. 7, 9, 10. It is arranged with a transversal interior wall 66, Figs. 9 and 10. The interior wall 66 is further provided with a central passage 68.
  • attachment means 70, Fig. 6, are arranged, in the embodiment shown as grooves for a bayonet connection.
  • the attachment means 70 of the chassis 64 are intended to interact with corresponding attachment means 72 on the distal end of the generally tubular housing part 16, Fig. 5.
  • the plunger rod 74 is intended to be in contact with a stopper arranged in the medicament container.
  • the plunger rod 74 is arranged inside a so called drive member extension 76, Figs. 1 1 and 12, having a generally tubular shape.
  • a proximal end of the drive member extension 76 is arranged with spline grooves 78 on its outer surface, Figs. 1 1 and 12.
  • the spline grooves 78 mate with corresponding spline ridges 80 on an inner surface of a generally tubularly shaped drive nut 82, Fig. 1 1.
  • the inner surface of the drive nut 82, Fig. 1 1 , is further provided with threads 84, which cooperate with threads 86 on the outer surface of the plunger rod 74.
  • the drive nut 82 is further arranged with an annular ledge 88 with a distally directed end surface having a number of slanting wedge-shaped surfaces 90.
  • the proximally directed surface of the interior wall 66 of the chassis 64 is arranged with
  • the plunger rod 74 is further arranged through a guide nut 94, Fig. 1 1.
  • the guide nut 94 is arranged with guide ledges 96 which cooperate with longitudinal grooves 98 of the plunger rod 74, Fig. 6, providing a rotational lock but allowing a longitudinal movement of the plunger rod 74 in relation to the guide nut 94.
  • the guide nut 94 fits into a guide nut lock member 100, which is attached to the chassis 64 via radially outwardly extending protrusions 102 fitting into recesses 104 in the interior surface of the chassis 64, Fig. 9.
  • the nut lock member 100 is arranged with tongues 106 that are arranged flexible in the generally radial direction.
  • the inner surfaces of the flexible tongues 106 are arranged with wedge-shaped teeth 108, Fig. 1 1 , extending in the radial direction.
  • the teeth 108 of the tongues 106 are intended to engage corresponding wedge-shaped teeth 1 10 arranged around the circumference of the guide nut 94.
  • the drive member extension 76 is arranged with a ring-shaped part 1 12, Fig. 1 1 , with a hollow interior, where the inner surface of the interior is arranged with transversal stop ledges 1 14. These stop ledges 1 14 cooperate with flexible arms 1 16 arranged at a proximal end of a generally elongated drive member 1 18, Fig. 12.
  • the stop ledges 1 14 and flexible arms 1 16 are arranged to provide a unidirectional lock such that the drive member 1 18 may only be rotated in one direction in relation to the drive member extension, where the flexible arms 1 16 slide over the stop ledges 1 14. In the other direction, the ends of the flexible arms 1 16 abut the stop ledges 1 14, thereby blocking their relative rotation.
  • the drive member 1 18 is further arranged with a disk-shaped member 120, Fig. 12. On the proximally directed side of the disk-shaped member 120, two stop ledges 122 are arranged diametrically on opposite sides of a longitudinal axis 124, Fig. 1 , of the device.
  • the stop ledges 122 are arranged to co-act with corresponding stop ledges 126, Fig. 10, arranged in the interior of the chassis 64 for limiting the rotation of the drive member 1 18.
  • the drive member 1 18 is arranged with a generally radially outwardly directed surface 128, Fig. 12, preferably arranged with a certain noticeable colour or indicia to be used as an indicator of the state of the device, as will be described.
  • the indicator surface 128 could be arranged with a bright colour, such as bright green or bright orange, or could have certain signs or letters like a check mark or "OK", just to mention a few feasible indicators.
  • the chassis is arranged with an opening or a transparent area 130, Fig. 8, through which the indicator surface may be visible.
  • the housing part 60 is arranged with an opening or a transparent area 132, Fig. 6, where the indicator surface 128 may be viewed.
  • the opening 132 may further be arranged with a magnifying lens so as to increase the visibility of the indicator.
  • a spiral drive spring 134 is arranged around the drive member 1 18 and attached with an inner end in an elongated slit 136, Fig. 12, in the drive member 1 18 and with the other end in a slit 138 in a spring house 140, Fig. 13.
  • the spring house 140 is in turn placed inside the distal part of the chassis 64, Fig. 10, and held fixed in relation to the chassis 64 by longitudinal grooves 142 in the outer surface of the spring house 140 fitting with corresponding ridges 144.
  • the spring house 140 is held in place in the chassis 64 by a spring house cover 146, Fig. 14, which is attached to the chassis 64 by proximally directed arms 148 with passages 150, which
  • the spring house cover 146 is further arranged with a distally directed tubular member 154.
  • the distal end of the drive member 1 18 extends into the tubular member 154 of the spring house cover 146.
  • the distal end of the drive member 64 is arranged with a number of longitudinally extending ledges 156, Fig. 13.
  • a generally tubular guide member 158, Fig. 13, 14, is further provided, having an end wall 160.
  • the end wall 160 is arranged with a central passage 162 with a shape corresponding to a cross- section of the distal end of the drive member 64 with the ledges 156, forming a keying function.
  • the distal end of the drive member 64 with the ledges 156 are further arranged to fit into a corresponding recess 164 on a spring force tensioning member 166, Fig.
  • the spring force tensioning member 166 is operably connected, e.g. rotationally connected, to the drive member.
  • the recess 164 is positioned on a central post 168 inside the spring force tensioning member 166, Fig. 15.
  • the spring force tensioning member 166 is further arranged with a number of proximally directed arms 170, which arms 170 are flexible in the generally radial direction.
  • the free ends of the arms 170 are arranged with inwardly extending ledges 172, which ledges 172 are designed to fit around an annular ledge 174, Fig. 14, arranged on the circumference of the tubular member 154.
  • a spring 176, Fig. 16 is further arranged between the end wall 160 of the guide member 158 and an interior, proximally directed wall of the spring force tensioning member 166, urging the latter in the distal direction.
  • an activation mechanism 178 is arranged in the device. It comprises an activation button 180 extending through an opening of one of the housing parts 60
  • the activation button 180 comprises two inwardly extending arms, 182, one on each side of the longitudinal direction 124 of the device.
  • Each arm 182 is arranged with a first surface 184 facing in the proximal direction.
  • the first surface 184 transitions into a second surface 186, inclined with respect to the first surface 184.
  • the second surface 186 thereafter transitions into a third surface 188 generally parallel with the first surface 184.
  • the arms 182 are in contact with a dose activator 190, Fig, 1 1 , comprising a ring- shaped body 192, Fig.
  • the ring-shaped body 192 is arranged with two elongated posts 194, extending in the longitudinal direction of the device. Each post is arranged with a groove 196, in which grooves the arms 182 of the activation button 180 fit, Fig. 17.
  • a distally directed end surface of the ring-shaped body 192 is arranged with a number of circumferentially directed stop ledges 198, Fig. 1 1 , the function of which will be described below.
  • the stop ledges 198 are to interact with stop ledges 200 on an outer surface of the drive member extension 76.
  • a compression spring 202, Fig. 13, is arranged between an interior surface of the activation button 180 and an outer side surface of the chassis 64 for urging the activation button 180 towards an extended position. Further a second compression spring 204, Fig.
  • the device is intended to function as follows. An appropriate medicament container 26 is placed in the medicament container holder 24 together with the medicament container guide member 40 such that its arms snap in engagement with the medicament holder. The medicament holder is then inserted into the proximal housing part 16. Then the medicament holder locking member 50 is pushed in engagement with the medicament container guide member 40.
  • the proximal housing part 12 is then connected to the distal housing part 14 and the chassis 64 via the attachment means 70, 72.
  • the distal end of the medicament container guide member 40 is designed such that it engages the outer surface of the nut lock member 100, whereby the tongues 106 are pressed radially inwards such that the teeth 108 of the tongues 106 engage the teeth 1 10 of the guide nut 94, whereby the guide nut 94 becomes rotationally locked.
  • the spring force tensioning member 166 When a dose is to be set and delivered the spring force tensioning member 166 is operated, e.g. rotated. In order to connect the spring force tensioning member 166 to the dose setting mechanism, the spring force tensioning member 166 is pushed in the proximal direction against the force of the spring 176. The spring force tensioning member 166 and the drive member 1 18 are then connected in that the ledges 156 fit into the recess 164. Thus, when the spring force tensioning member 166 is rotated, the drive member 1 18 is also rotated. The rotation of the drive member 1 18 causes the spiral drive spring 134 to be tensioned from an initial state where it was pre- tensioned during manufacture of the device.
  • the flexible arms 1 16 of the drive member 1 18 move out of contact with the stop ledges 1 14 of the ring-shaped member 1 12 of the drive member extension 64 until they are moved in contact with subsequent stop ledges 1 14.
  • the drive member 1 18 is prevented from being rotated back because the contact of the flexible arms 1 16 with the stop ledges 1 14.
  • the drive member extension 64 is in turn prevented from rotating because the stop ledges 198 of the dose activator 192 are in contact with the stop ledges 200 on the drive member extension 64.
  • the spring force tensioning member 166 is rotated until the stop ledge 122 of the drive member 1 18 comes in contact with the corresponding stop ledge 126 of the chassis 64.
  • the user may now position the medicament delivery device at the delivery site and may manually activate the medicament delivery device by pressing the activation button 180 into the device against the force of the return spring 202.
  • the movement of the activation button 180 causes the arms 182 to slide in the grooves 196 of the posts 194.
  • the inclined second surface 186 is moved in contact with a distally directed surface of the groove 196 and thereafter the third surface 188, Fig. 18.
  • This contact of the second and third surfaces forces the ring- shaped body 192 in the proximal direction.
  • This in turn causes the stop ledges 198 of the dose activator 190 to move out of contact with the stop ledges 200 of the drive member extension 64.
  • the plunger rod 74 Due to the rotation of the drive nut 82, which is in threaded engagement with the threads 86 of the plunger rod 74, and because of the rotational lock of the plunger rod with the guide nut 94, the plunger rod 74 is axially advanced, which causes it to move the stopper 36 inside the medicament container 26 and to force the

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Abstract

A medicament delivery device for delivering metered doses of medicament, wherein an indicator mechanism (128, 132) is operably connected to an drive member (118) and arranged to visibly indicate to a user of the device when a spring force tensioning member (166) has been operated such that the device is ready for dose delivery.

Description

MEDICAMENT DELIVERY DEVICE
TECHNICAL AREA
The present invention relates to a medicament delivery device and in particular a device capable of delivering a number of predetermined metered doses.
BACKGROUND OF INVENTION
There are a large number of devices for delivering medication for absorption in the respiratory system or for medicament delivery to the eyes and one strong trend is to develop devices for self-administration. Traditionally oral or nasal medication was intended for treatment of diseases in the trachea, bronchi and/or lungs, and in particular acute or chronic symptoms of asthma. However, much research is now performed on administration of medicament via the lungs in treatment of many other ailments due to beneficial absorption rate and reduced side effects. Further, oral administration provides a greater safety than delivery devices using needles because of the problem with possible contamination from a used needle. A similar situation exists for delivery of medicament to the eyes of a patient.
However, there are a number of medicament compositions that are not compatible with existing devices and there are further a number of drawbacks with existing devices. For example aerosol dispensers utilise a propellant which provides the force to aerosolize the medicament in liquid form. However, this requires a special type of pressurised canister, usually of metal, which increases the cost for manufacturing and affects the environment.
One example of a device which could be used for metered oral administration is described in the document WO 201 1/043712. The disclosed device comprises a plunger rod, which, when driven by a pre-tensioned helical spring, forces a stopper into a cartridge containing medicament, whereby a dose of medicament is delivered from an administration member. The administration member could be a mouth piece or a nasal piece. With the device according to WO 201 1/043712, it is possible to set a dose by turning a spring force tensioning member at a distal end of the device. This action also tensions a spiral spring for delivering a dose. The setting and delivery of doses may be made a number of times until the medicament container is empty.
A drawback with the device of WO 201 1/043712 is that there is no indication that a dose has been set and that the device is ready for dose delivery. This may be a drawback where the device user either is not very used to handling the device so that he/she is uncertain that the device has been handled properly for making it ready for dose delivery. Also for experienced users, it is advantageous to be provided with a positive indication that the handling steps prior to dose delivery have been performed correctly.
There is thus still a need for devices where a number of doses may be delivered and where handling steps need to be performed prior to each dose delivery to be provided with information and/or verification that the handling steps have been performed such that the device is ready for dose delivery.
BRIEF DESCRIPTION OF INVENTION
As used herein, the term "liquid" encompasses all solutions, suspensions, emulsions, oils, gels and so forth, which generally behave as liquids at operating temperatures. The term explicitly includes solid compositions dissolved or dispersed in a liquid carrier. Materials behaving as highly viscous liquids are also included. In the present application, when the term "distal part/end" is used, this refers to the part/end of the medical delivery device, or the parts/ends of the members thereof, which during use of the device is located the furthest away from the delivery site of the patient. Correspondingly, when the term "proximal part/end" is used, this refers to the part/end of the device, or the parts/ends of the members thereof, which under use of the device is located closest to the delivery site of the patient.
The aim of the present invention is to remedy the drawbacks of the state of the art devices. This is obtained by a medicament delivery device according to the features of the independent patent claim 1. Preferable embodiments of the invention form the subject of the dependent patent claims.
The present invention pertains to a medicament delivery device for delivering metered doses of medicament. It comprises preferably at least one generally elongated tubular chassis, the chassis having opposite distal and proximal ends.
Inside said chassis, a threaded plunger rod may be arranged. The plunger rod is arranged to cooperate with a drive nut, which is threadedly connected to the threaded plunger rod.
The device may further preferably be provided with a drive member. This drive member is preferably rotatably connected to a spring force tensioning member. In a preferred embodiment, the spring force tensioning member is accessible outside the distal end of the chassis. It is however to be understood that the spring force tensioning member may be placed on other locations on the chassis.
Further, the drive member is preferably connected to the drive nut via an drive member extension such that said drive member extension and said drive member are operably interconnected for providing a rotational lock of the drive member extension in an opposite direction when said drive member is rotated by said spring force tensioning member.
Also, according to a preferred embodiment, the drive member extension and said drive nut may be operably interconnected for providing a rotational lock of the drive nut in relation to the drive member extension.
The device is further arranged with spring force member, that in one preferred embodiment is in the form of a spiral spring. It is however to be understood that other types of spring force member may be used for the same function.
The spring force member has a first end connected to the drive member and a second end connected to a fixed point on the chassis such that said spring force member is tensioned when said spring force tensioning member and said drive member are rotated.
In order to handle the plunger rod, a guide nut may be arranged with guide ledges which may cooperate with longitudinal grooves of the plunger rod for providing a rotational lock but allowing a longitudinal movement of the plunger rod in relation to the guide nut.
In order to facilitate the handling of the medicament delivery device, a manually operated activation means is releasably interconnected to said drive member extension by engagement means for providing a rotational locking of the drive member extension in any direction when said drive member is rotated and said spring force member is tensioned by handling said spring force tensioning member for setting the device ready for delivery of a dose of medicament.
According to the present invention, it is characterised in an indicator mechanism operably connected to said drive member and arranged to visibly indicate to a user of the device when said spring force tensioning member has been operated such that the device is ready for dose delivery.
In this manner, the user is informed by the indicator mechanism when the spring force tensioning member has been operated to an extent that the device is ready for use. The user is thus provided with positive information and can be assured that when the indication is visible, the device is ready for dose delivery.
According to one solution, the indicator mechanism may comprise a surface operably connected to said drive member, which surface is arranged with a noticeable indication member, the indicator mechanism further comprising an opening in said chassis for viewing said surface. Thus, when the drive member is turned, the surface is positioned in line with the opening, and is thus visible to the user.
According to a preferable solution of the invention, the surface may be operably arranged at said drive member such that said indication member is visible in said opening when said spring force tensioning member has been operated, i.e. showing that the device is ready for dose delivery. In this manner, the indicator becomes visible only when the spring force tensioning member, and thus the drive member, has been turned such that a dose has been set and the device is ready for dose delivery.
In order to be clearly distinctive and easily visible to a user, the indication member comprises a distinct colour. This colour may for example be a clear green colour, indicating a ready device in a positive way. However, the colour may be chosen such that it is a clear alert, such as orange, yellow, possibly also fluorescent.
In addition to a colour, or instead of a colour, the indication member may comprise indicia. The indicia could for example be a check mark, letters, words like "OK", a graphic symbol or the like, just to mention a few.
In order to elevate the visibility further, the opening may be arranged with a magnifying lens or the like, where the indication member is even more clearly visible.
According to a further aspect of the invention the medicament delivery device is an inhalation device, an eye spray device or an injector.
These and other aspects of, and advantages with, the present invention will become apparent from the following detailed description of the invention and from the accompanying drawings.
BRIEF DESCRIPTION OF DRAWINGS
In the following detailed description of the invention, reference will be made to the accompanying drawings, of which Fig. 1 is a perspective view of a medicament delivery device comprising the present invention,
Fig. 2 is an exploded view of the proximal part of Fig. 1 , Fig 3 is a cross-sectional view of the proximal part of Fig. 2
Fig 4 is a detailed view of a distal area of the proximal part of Fig. 2
Fig 5 is a perspective view of a distal area of the proximal part of Fig. 2
Fig 6 is a perspective view of a distal part of the device of Fig. 1
Fig 7 is an exploded view of the distal part of Fig. 6
Fig 8 is a cross-sectional view of the distal part of Fig. 6
Figs. 9-16 are detailed views of components comprised in the distal part of Fig. 6,
Figs. 17-18 are detailed views showing different functional states. DETAILED DESCRIPTION OF THE INVENTION
One embodiment of a device shown in the drawings comprises a generally elongated body 10. The body 10 is in the embodiment shown divided into two parts; a proximal part 12 and a distal part 14, Fig. 1.
The proximal part 12 comprises generally tubular housing part 16, Fig. 2. A proximal end of the housing part 16 is arranged with an attachment area 18, Fig. 2, onto which a medicament delivery member 20 can be releasably attached. The attachment means between the medicament delivery member 20 and the housing 16 could for example be ledges 22 that snap into corresponding grooves 23, Fig. 3. It is however to be understood that other types of attachment means could be utilized. The medicament delivery member 20 is in the embodiment shown a mouthpiece through which a user inhales when a dose of medicament is to be delivered. It is however to be understood that other types of medicament delivery members could be used, such as nasal pieces, eye pieces and even injection needles and the like. The proximal part 12 is further arranged with a generally elongated tubular
medicament container holder 24, Fig. 2, arranged to accommodate a medicament container 26. The medicament container holder 24 is arranged with generally radially flexing legs 28, Fig. 3, with outwardly extending ledges 30 that fit into recesses 32 in the housing part 16.
The medicament container 26 is in the embodiment shown arranged with a proximal neck 34 and a movable stopper 36 inside the container. At the proximal end of the medicament container holder 24, a nebulizing nozzle 38 is arranged, Figs. 2 and 3. The nebulizing nozzle 38 contains a chip (not shown) with a plurality of micro channels capable of creating an aerosol of droplets of medicament.
A medicament container guide member 40, Figs. 2 and 3, is arranged with a central passage and is intended to be pushed onto the medicament container 26 from its proximal end and into contact with an annular ledge 42 (Fig. 4) at a distal end of the medicament container 26, Fig. 2. The medicament container guide member 40 is arranged with a number of proximally extending arms 44, Fig. 3, arranged generally radially flexible and having outwardly extending protrusions 46. These protrusions 46 are arranged to grip around an annular ledge 48 of the housing for locking the medicament container guide member 40 and thus the medicament container 26 in the radial direction.
A medicament holder locking member 50, Fig. 4, is arranged to be pushed into the distal end of the medicament container holder 24, and moved in contact with a distally directed end surface of the medicament container 24. The medicament holder locking member 50 is arranged with a central passage 52 and is provided with a number of generally radially flexible tongues 54 having outwardly extending protrusions 56, Fig. 4. These protrusions 56 are arranged to fit into recesses 58 on inner surfaces of the medicament container guide member 40 such that when the medicament holder locking member 50 is in place, the medicament container 26 is locked in the axial direction. The distal part 14 is arranged with a housing. In the embodiment shown the housing is designed as two housing halves 60, 62, Fig. 6. It is however to be understood that the housing may be arranged in other ways and in more parts without departing from the scope of the invention.
Inside the housing parts, a generally tubular chassis 64 is arranged, Figs. 7, 9, 10. It is arranged with a transversal interior wall 66, Figs. 9 and 10. The interior wall 66 is further provided with a central passage 68. At a proximal end of the chassis, attachment means 70, Fig. 6, are arranged, in the embodiment shown as grooves for a bayonet connection. In this context it is to be understood that other types of attachment means may be employed, such as threads, snap-on fittings or the like, all within the imagination of the person skilled in the art. The attachment means 70 of the chassis 64 are intended to interact with corresponding attachment means 72 on the distal end of the generally tubular housing part 16, Fig. 5.
Coaxially arranged inside the chassis 64 and extending in the longitudinal direction of the device is an elongated plunger rod 74, Figs. 6 and 7. The plunger rod 74 is intended to be in contact with a stopper arranged in the medicament container. The plunger rod 74 is arranged inside a so called drive member extension 76, Figs. 1 1 and 12, having a generally tubular shape. A proximal end of the drive member extension 76 is arranged with spline grooves 78 on its outer surface, Figs. 1 1 and 12. The spline grooves 78 mate with corresponding spline ridges 80 on an inner surface of a generally tubularly shaped drive nut 82, Fig. 1 1. The inner surface of the drive nut 82, Fig. 1 1 , is further provided with threads 84, which cooperate with threads 86 on the outer surface of the plunger rod 74. The drive nut 82 is further arranged with an annular ledge 88 with a distally directed end surface having a number of slanting wedge-shaped surfaces 90. The proximally directed surface of the interior wall 66 of the chassis 64 is arranged with
corresponding slanting wedge-shaped surfaces 92, Fig. 9.
The plunger rod 74 is further arranged through a guide nut 94, Fig. 1 1. The guide nut 94 is arranged with guide ledges 96 which cooperate with longitudinal grooves 98 of the plunger rod 74, Fig. 6, providing a rotational lock but allowing a longitudinal movement of the plunger rod 74 in relation to the guide nut 94. The guide nut 94 fits into a guide nut lock member 100, which is attached to the chassis 64 via radially outwardly extending protrusions 102 fitting into recesses 104 in the interior surface of the chassis 64, Fig. 9. The nut lock member 100 is arranged with tongues 106 that are arranged flexible in the generally radial direction. The inner surfaces of the flexible tongues 106 are arranged with wedge-shaped teeth 108, Fig. 1 1 , extending in the radial direction. The teeth 108 of the tongues 106 are intended to engage corresponding wedge-shaped teeth 1 10 arranged around the circumference of the guide nut 94.
Further, the drive member extension 76 is arranged with a ring-shaped part 1 12, Fig. 1 1 , with a hollow interior, where the inner surface of the interior is arranged with transversal stop ledges 1 14. These stop ledges 1 14 cooperate with flexible arms 1 16 arranged at a proximal end of a generally elongated drive member 1 18, Fig. 12.
However the stop ledges 1 14 and flexible arms 1 16 are arranged to provide a unidirectional lock such that the drive member 1 18 may only be rotated in one direction in relation to the drive member extension, where the flexible arms 1 16 slide over the stop ledges 1 14. In the other direction, the ends of the flexible arms 1 16 abut the stop ledges 1 14, thereby blocking their relative rotation. The drive member 1 18 is further arranged with a disk-shaped member 120, Fig. 12. On the proximally directed side of the disk-shaped member 120, two stop ledges 122 are arranged diametrically on opposite sides of a longitudinal axis 124, Fig. 1 , of the device. The stop ledges 122 are arranged to co-act with corresponding stop ledges 126, Fig. 10, arranged in the interior of the chassis 64 for limiting the rotation of the drive member 1 18.
Further, according to the invention, the drive member 1 18 is arranged with a generally radially outwardly directed surface 128, Fig. 12, preferably arranged with a certain noticeable colour or indicia to be used as an indicator of the state of the device, as will be described. The indicator surface 128 could be arranged with a bright colour, such as bright green or bright orange, or could have certain signs or letters like a check mark or "OK", just to mention a few feasible indicators. In connection with this surface 128, the chassis is arranged with an opening or a transparent area 130, Fig. 8, through which the indicator surface may be visible. Also the housing part 60 is arranged with an opening or a transparent area 132, Fig. 6, where the indicator surface 128 may be viewed. The opening 132 may further be arranged with a magnifying lens so as to increase the visibility of the indicator.
A spiral drive spring 134, Fig. 13, is arranged around the drive member 1 18 and attached with an inner end in an elongated slit 136, Fig. 12, in the drive member 1 18 and with the other end in a slit 138 in a spring house 140, Fig. 13. The spring house 140 is in turn placed inside the distal part of the chassis 64, Fig. 10, and held fixed in relation to the chassis 64 by longitudinal grooves 142 in the outer surface of the spring house 140 fitting with corresponding ridges 144. The spring house 140 is held in place in the chassis 64 by a spring house cover 146, Fig. 14, which is attached to the chassis 64 by proximally directed arms 148 with passages 150, which
accommodate ledges 152 on the outer surface of the chassis 64. The spring house cover 146 is further arranged with a distally directed tubular member 154.
The distal end of the drive member 1 18 extends into the tubular member 154 of the spring house cover 146. The distal end of the drive member 64 is arranged with a number of longitudinally extending ledges 156, Fig. 13. A generally tubular guide member 158, Fig. 13, 14, is further provided, having an end wall 160. The end wall 160 is arranged with a central passage 162 with a shape corresponding to a cross- section of the distal end of the drive member 64 with the ledges 156, forming a keying function. The distal end of the drive member 64 with the ledges 156 are further arranged to fit into a corresponding recess 164 on a spring force tensioning member 166, Fig. 15, such that the spring force tensioning member is operably connected, e.g. rotationally connected, to the drive member. The recess 164 is positioned on a central post 168 inside the spring force tensioning member 166, Fig. 15. The spring force tensioning member 166 is further arranged with a number of proximally directed arms 170, which arms 170 are flexible in the generally radial direction. The free ends of the arms 170 are arranged with inwardly extending ledges 172, which ledges 172 are designed to fit around an annular ledge 174, Fig. 14, arranged on the circumference of the tubular member 154. A spring 176, Fig. 16, is further arranged between the end wall 160 of the guide member 158 and an interior, proximally directed wall of the spring force tensioning member 166, urging the latter in the distal direction.
Further, an activation mechanism 178, Fig 17, is arranged in the device. It comprises an activation button 180 extending through an opening of one of the housing parts 60 The activation button 180 comprises two inwardly extending arms, 182, one on each side of the longitudinal direction 124 of the device. Each arm 182 is arranged with a first surface 184 facing in the proximal direction. The first surface 184 transitions into a second surface 186, inclined with respect to the first surface 184. The second surface 186 thereafter transitions into a third surface 188 generally parallel with the first surface 184. The arms 182 are in contact with a dose activator 190, Fig, 1 1 , comprising a ring- shaped body 192, Fig. 1 1 , surrounding a part of the drive member extension 76. The ring-shaped body 192 is arranged with two elongated posts 194, extending in the longitudinal direction of the device. Each post is arranged with a groove 196, in which grooves the arms 182 of the activation button 180 fit, Fig. 17.
A distally directed end surface of the ring-shaped body 192 is arranged with a number of circumferentially directed stop ledges 198, Fig. 1 1 , the function of which will be described below. The stop ledges 198 are to interact with stop ledges 200 on an outer surface of the drive member extension 76. A compression spring 202, Fig. 13, is arranged between an interior surface of the activation button 180 and an outer side surface of the chassis 64 for urging the activation button 180 towards an extended position. Further a second compression spring 204, Fig. 8, is arranged between a proximally directed end surface of the ring-shaped body 192 of the dose activator 190 and a distally directed surface of the transversal wall 66 for urging the ring-shaped body 192 in the distal direction and in engagement between the stop ledges 198 of the ring-shaped body 192 and the stop ledges 200 of the drive member extension 76. The device is intended to function as follows. An appropriate medicament container 26 is placed in the medicament container holder 24 together with the medicament container guide member 40 such that its arms snap in engagement with the medicament holder. The medicament holder is then inserted into the proximal housing part 16. Then the medicament holder locking member 50 is pushed in engagement with the medicament container guide member 40. The proximal housing part 12 is then connected to the distal housing part 14 and the chassis 64 via the attachment means 70, 72. The distal end of the medicament container guide member 40 is designed such that it engages the outer surface of the nut lock member 100, whereby the tongues 106 are pressed radially inwards such that the teeth 108 of the tongues 106 engage the teeth 1 10 of the guide nut 94, whereby the guide nut 94 becomes rotationally locked.
When a dose is to be set and delivered the spring force tensioning member 166 is operated, e.g. rotated. In order to connect the spring force tensioning member 166 to the dose setting mechanism, the spring force tensioning member 166 is pushed in the proximal direction against the force of the spring 176. The spring force tensioning member 166 and the drive member 1 18 are then connected in that the ledges 156 fit into the recess 164. Thus, when the spring force tensioning member 166 is rotated, the drive member 1 18 is also rotated. The rotation of the drive member 1 18 causes the spiral drive spring 134 to be tensioned from an initial state where it was pre- tensioned during manufacture of the device.
During rotation, the flexible arms 1 16 of the drive member 1 18 move out of contact with the stop ledges 1 14 of the ring-shaped member 1 12 of the drive member extension 64 until they are moved in contact with subsequent stop ledges 1 14. The drive member 1 18 is prevented from being rotated back because the contact of the flexible arms 1 16 with the stop ledges 1 14. Further, the drive member extension 64 is in turn prevented from rotating because the stop ledges 198 of the dose activator 192 are in contact with the stop ledges 200 on the drive member extension 64. The spring force tensioning member 166 is rotated until the stop ledge 122 of the drive member 1 18 comes in contact with the corresponding stop ledge 126 of the chassis 64. This ensures that the user cannot turn the spring force tensioning member 166 beyond a pre-set position. Therefore a too large dose cannot be set. Now that a dose is set the device is ready for use. A positive feed-back to the user that the device is ready is shown in the opening or window 132 of the device because the turning of the drive member has positioned the indication surface 128 in line with the opening or window 132 of the device. The user is then able to notice the colour or symbol that is an indication that the device is ready for use.
The user may now position the medicament delivery device at the delivery site and may manually activate the medicament delivery device by pressing the activation button 180 into the device against the force of the return spring 202. The movement of the activation button 180 causes the arms 182 to slide in the grooves 196 of the posts 194. After a certain movement, the inclined second surface 186 is moved in contact with a distally directed surface of the groove 196 and thereafter the third surface 188, Fig. 18. This contact of the second and third surfaces forces the ring- shaped body 192 in the proximal direction. This in turn causes the stop ledges 198 of the dose activator 190 to move out of contact with the stop ledges 200 of the drive member extension 64. The drive member extension 64 and thereby the drive member 1 18, because of the connection between the flexible arms 1 16 and the stop ledges 1 14, are now free to rotate by the force of the spring 134, and due to the splines connection between the drive member extension 64 and the drive nut 82, the latter is also rotated.
Due to the rotation of the drive nut 82, which is in threaded engagement with the threads 86 of the plunger rod 74, and because of the rotational lock of the plunger rod with the guide nut 94, the plunger rod 74 is axially advanced, which causes it to move the stopper 36 inside the medicament container 26 and to force the
medicament through the medicament delivery member, e.g. the nebulizing nozzle 38 and the mouth-piece 20. It is to be understood that the embodiment described above and shown in the drawings is to be regarded only as a non-limiting example of the invention and that it may be modified in many ways within the scope of the patent claims.

Claims

PATENT CLAIMS
1. A metered droplet medicament delivery device comprising:
- a generally elongated tubular chassis (64) having opposite distal and proximal ends;
- a drive mechanism arranged within the chassis;
- a spring force tensioning member (166) accessible outside the distal end of the chassis (64) and operably connected to the drive mechanism;
- spring force member (134) having a first end connected to the spring force tensioning member through the drive mechanism and a second end connected to a fixed point on the chassis (64) such that said spring force member (134) is tensioned when said spring force tensioning member (166) is operated;
- a manually operated activation means (178, 180, 182, 192) releasably interconnected to said drive mechanism and configured to interact with said drive mechanism such that after the spring force member (134) is tensioned, operation of said spring force tensioning member (166) is prevented;
characterised in that the device further comprises an indicator mechanism (128, 132) operably connected to said drive mechanism and arranged to visibly indicate to a user of the device when said spring force tensioning member (166) has been operated such that the device is ready for dose delivery.
2. A metered droplet medicament delivery device according to claim 1 , wherein said drive mechanism comprises
- a threaded plunger rod (74);
- a drive nut (82) threadedly connected to the threaded plunger rod;
- an drive member (1 18) rotatably connected to a spring force tensioning
member (166) accessible outside the distal end of the chassis (64), said drive member (1 18) being connected to the drive nut (82) via an drive member extension (76), wherein said drive member extension (76) and said drive member (1 18) are operably interconnected to provide a unidirectional rotational lock of the drive member (1 18) relative to the drive member extension (76) when said drive member (1 18) is rotated by said spring force tensioning member (166), wherein said drive member extension (76) and said drive nut (82) are operably interconnected for providing a rotational lock of the drive nut (82) in relation to the drive member extension (76); - a guide nut (94) arranged with guide ledges (96) which cooperate with longitudinal grooves (98) of the plunger rod (74) for providing a rotational lock but allowing a longitudinal movement of the plunger rod in relation to the guide nut,
3. A metered droplet medicament delivery device according to claim 2, wherein said manually operated activation means (178, 180, 182, 192) is releasably interconnected to said drive member extension by engagement means (198, 200) for providing a rotational lock of the drive member extension (76) in any direction when said drive member (1 18) is rotated and said spring force member (134) is tensioned by operation of said spring force tensioning member (166) for setting the device ready for delivery of a dose of medicament.
4. A metered droplet medicament delivery device according to claim 2, wherein the first end of said spring force member (134) is connected to the drive member
(1 18).
5. A metered droplet medicament delivery device according to claim 1 , wherein said indicator mechanism (128, 132) is operably connected to said drive member (1 18) and arranged to visibly indicate through the chassis to the user of the device when said spring force tensioning member (166) has been operated such that the device is ready for dose delivery.
A metered droplet medicament delivery device according to claim 5, wherein said
Figure imgf000017_0001
indicator mechanism (128, 132) comprises a surface (128) operably connected to said drive member (1 18), which surface (128) is arranged with a noticeable indication member, and wherein the chassis is arranged with an opening.
7. A metered droplet medicament delivery device according to claim 6, wherein said surface (128) is operably arranged to said drive member (1 18) such that said indication member is visible in said opening when said spring force tensioning member (166) has been operated such that the device is ready for dose delivery.
8. A metered droplet medicament delivery device according to claims 5 or 6 wherein said indication member comprises a distinct colour.
9. A metered droplet medicament delivery device according to claims 5 or 6
wherein said indication member comprises a symbol.
10. A metered droplet medicament delivery device according to any of the claims 6, wherein said opening is arranged with a magnifying lens.
1 1. A metered droplet medicament delivery device according claim 1 , wherein said device is an inhaler.
12. A metered droplet medicament delivery device according claim 1 , wherein said device is an eye spray device.
13. A metered droplet medicament delivery device according claim 1 , wherein said device is an injector.
PCT/EP2014/050569 2013-01-15 2014-01-14 Medicament delivery device WO2014111370A1 (en)

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CA2897350A CA2897350A1 (en) 2013-01-15 2014-01-14 Medicament delivery device
CN201480007685.0A CN104994896A (en) 2013-01-15 2014-01-14 Medicament delivery device
EP14701927.7A EP2945666B1 (en) 2013-01-15 2014-01-14 Medicament delivery device
DK14701927T DK2945666T3 (en) 2013-01-15 2014-01-14 Drug delivery device

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