WO2010105376A1 - Dispositif d'administration à unité de produit interchangeable - Google Patents

Dispositif d'administration à unité de produit interchangeable Download PDF

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Publication number
WO2010105376A1
WO2010105376A1 PCT/CH2010/000058 CH2010000058W WO2010105376A1 WO 2010105376 A1 WO2010105376 A1 WO 2010105376A1 CH 2010000058 W CH2010000058 W CH 2010000058W WO 2010105376 A1 WO2010105376 A1 WO 2010105376A1
Authority
WO
WIPO (PCT)
Prior art keywords
product
piston rod
unit
product unit
movement
Prior art date
Application number
PCT/CH2010/000058
Other languages
German (de)
English (en)
Inventor
Patrick Hostettler
Thomas Schuler
Peter Stettler
Jürgen Wittmann
Original Assignee
Tecpharma Licensing 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 Tecpharma Licensing Ag filed Critical Tecpharma Licensing Ag
Publication of WO2010105376A1 publication Critical patent/WO2010105376A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—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
    • 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
    • A61M5/31545—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/1456—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31541—Means preventing setting of a dose beyond the amount remaining in the cartridge

Definitions

  • the present invention relates to an administration device, preferably in the form of an injection pen, which comprises a dispensing unit with a drive device for generating a drive rotary movement and a replaceable product unit connectable therewith to a product container.
  • an injection pen i. an administration device in stick form for the subcutaneous administration of a liquid medicament, in which the distribution takes place automatically after the metering and release of the pen.
  • the medicament is present in a product container in the form of a carpule, i. in a container with a cylindrical wall portion and plug movable therein.
  • This product container is inserted into a container holder, which is connected to the housing of the pen via a bayonet-type connection.
  • a release of the drug takes place in that the plug is advanced in the carpule.
  • a threaded rod at the distal end of a feed flange is arranged, which acts on the plug of the carpule.
  • the dosing is done by turning a dosing knob.
  • a coil spring is biased.
  • Initiation of administration is accomplished by pressing a release button in the distal direction.
  • the coil spring is released and generates a drive rotary motion. This is converted via a threaded engagement in a feed movement of rotatably guided, serving as a feed element threaded rod.
  • the unit of container holder and product container is separated from the remainder of the pen (also referred to below as the dispensing unit).
  • the Aus passiser contains all other mechanical components, in particular the feed element in the form of the threaded rod and the entire mechanism for converting the drive rotary motion in a feed movement of the threaded rod.
  • the product container is removed from the container holder and replaced with a new product container. Subsequently, the unit of container holder and new product container is reconnected to the Aus welltician.
  • the pen When connecting the unit from the container holder and the new product container, the pen is automatically reset to its initial state. On the one hand, the display of a last set dose is reset to zero. On the other hand, a dose limiting element is reset, which prevents that more than the remaining amount present in the container is metered.
  • the mechanism for resetting the pen is relatively complicated. To reset also relatively large forces are needed.
  • the pen also offers only a limited flexibility, since the slope of the threaded rod is specified and thus the administrable maximum single dose is inevitably predetermined.
  • an injection pen which is modularly constructed as a "semi-disposable" device
  • the pen comprises a reusable dispensing unit and a disposable product unit
  • the disposable product unit comprises besides a container holder and a product container with displaceable product plug also
  • the piston rod has an external thread threadingly engaged with an internal thread of the dose setting member
  • an injection pen is disclosed, which is also constructed as a "semi-disposable" device
  • the pen in turn comprises a dispensing unit with a dosing and actuating mechanism and a product unit. that the piston rod is advanced linearly through the Aus welltician.
  • a device for administering a fluid product which comprises: a dispensing unit with a drive device for generating a
  • Driving rotational movement about an axis of rotation a product container for the fluid product, a piston rod, wherein the fluid product is distributed by a feed movement of the piston rod along the rotational axis in a distal direction from the product container, and a conversion means for converting the drive rotational movement in a feed movement of the piston rod.
  • the product container, the piston rod and the conversion device together form a replaceable product unit, which is detachably fastened to the dispensing unit so that the product unit as a whole, that is to say together with the piston rod and the conversion device, can be removed from the dispensing unit. This is preferably done by a simple movement, which comprises a rotational movement about the axis of rotation and a displacement along the axis of rotation.
  • the product unit may comprise further components, in particular a container holder, which receives the actual product container and to which the conversion device is attached.
  • the conversion device can also be attached directly to a suitably ausgestaltetem product container, which may for example consist of a suitable plastic.
  • the device may be referred to as a semi-disposable device.
  • the reusable unit (“reusable module”) is here the Aus thoroughiser, in which the most important, usually relatively complex and therefore relatively expensive mechanical components are housed to generate the drive rotary motion.
  • the disposable unit (“disposable module”) is the entire product unit together with the components for converting the drive rotary motion into a feed of the piston rod.
  • the device is preferably in the form of a pen, in particular as an injection pen; in this case, the product unit is arranged in a distal area of the pen-shaped device, and the dispensing unit is arranged in a proximal area of the device.
  • the product unit and the Aus thoroughly maybe are arranged substantially coaxially with each other with respect to the axis of rotation, hu area of the proximal end of the device is preferably an actuating element for triggering an administration, which cooperates with the drive means.
  • At the distal end of the device is then preferably an injection needle for piercing into the skin of a patient present, or the distal end is preferably designed specifically for the attachment of such an injection needle, in particular for the attachment of a known needle adapter.
  • the dispensing unit may for example be a purely mechanical device that converts a linear feed movement of an actuating element in the form of a manually operable feed knob into a rotation.
  • Such devices are known from the prior art in various embodiments. But it may also include, for example, a small electric motor or other means for generating the drive rotational movement, wherein the actuating element may then comprise an electrical switch.
  • the Aus thoroughly maybetician includes a mechanically biased spring drive, which allows a battery-independent automatic distribution after triggering the discharge process.
  • the dispensing unit preferably comprises: a rotatable dosing device for setting a dose to be administered by a dosing rotary movement about the axis of rotation; a drive device with a spring element, which can be brought by the Dosierburnterrorism the metering device from an initial state to a prestressed state in which a biasing energy is stored in the spring element, wherein the spring element is adapted to generate the drive rotational movement by moving it from the prestressed state in returns the initial state; as well as a manually operable triggering device, the so by a Actuator is operable to release the spring element for movement from the prestressed state to the initial state.
  • the metering device comprises a sleeve-like metering button, which faces the housing of the dispensing device
  • Triggering device comprises a release button as an actuator, which in the distal
  • the product unit moves some internal mechanical elements of the dispensing unit when it is disconnected from or connected to the dispensing unit.
  • the device preferably has one or more of the following features:
  • the dispensing unit has a housing and a housing-fixed mechanism holder with at least one first curved path and at least one second curved path (this mechanism holder can also be formed integrally with the housing).
  • This mechanism holder can also be formed integrally with the housing.
  • the Aus thoroughly maybe has a bayonet sleeve, which is guided with a pin in the first cam track so that it is forced relative to the mechanism holder for a movement that includes both a rotation about the axis of rotation and a longitudinal displacement along the axis of rotation, and in the at least the piston rod can be inserted.
  • the product unit is feasible with a pin in the second curved path, so that the product unit when loosening and securing the product unit relative to the Aus wellech is also constrained for a movement that includes both a rotation about the axis of rotation and a longitudinal displacement along the axis of rotation.
  • the bayonet sleeve is designed and arranged so that it is at least partially taken along by the product unit when loosening and securing the product unit to the Aus wellech.
  • the second curved path has in one
  • the distal portion preferably prefers a greater pitch (ie, a smaller angle) relative to the longitudinal axis than the first cam track so that the product unit moves relative to the bayonet sleeve along the longitudinal axis when guided in the distal portion of the second cam track.
  • the bayonet sleeve preferably serves in particular for automatically resetting the drive device, in particular a display device for a set dose.
  • the bayonet sleeve is preferably coupled to the drive means, e.g. via a sleeve-like driver, that during its movement when removing the product unit from the Ausurgiiser the drive means resets in its initial state.
  • the apparatus preferably has one or more of the following features:
  • the Aus thoroughlytician has a rotatable coupling input member, which is drivable for carrying out the drive rotational movement.
  • the conversion unit of the product unit has a rotatable coupling output member.
  • the clutch input member and the clutch output member are adapted to cooperate in an assembled state of the product unit and the Aus thoroughly maybehow such that the drive rotational movement is transferable from the clutch input member to the clutch output member to eject the fluid product from the product container.
  • the clutch input member and the clutch output member are at a
  • the coupling input member and the coupling output member preferably have complementary engagement structures, e.g. Gears, to make a positive connection with respect to a rotation about the axis of rotation.
  • complementary engagement structures e.g. Gears
  • the clutch input member and the clutch output member are also preferred for power transmission along the axis of rotation by a Schriappitati connectable.
  • the clutch input member and the clutch output member are preferably configured to at least partially receive the piston rod in its interior.
  • these members are preferably designed as coupling sleeves whose inner diameter is sufficiently large that they can at least partially accommodate the piston rod.
  • the conversion of the rotational movement in a feed movement of the piston rod is preferably carried out by the piston rod is pre-screwed relative to the product container.
  • the piston rod is preferably designed as an (outer) threaded rod and is in a threaded engagement with a threaded nut which is stationary relative to the product container during operation of the device.
  • the conversion device then preferably comprises a rotatable element with which the piston rod is non-rotatably and longitudinally displaceably connected.
  • this rotatable member is engageable with a clutch output member to transmit the drive rotational movement from the clutch output member to the rotatable member and the piston rod.
  • a one-way clutch is formed between the clutch output member and the rotatable member to transmit the drive rotational movement from the clutch output member to the rotatable member, but to prevent rotational movement of the rotatable member in a direction opposite to the drive rotational movement.
  • the present invention provides a replaceable product unit specifically adapted for use in an administering device of the type described above.
  • This comprises a product container for a fluid product, a piston rod with an external thread, a conversion device for converting a drive rotational movement in a feed movement of the piston rod, and at least one connecting element for establishing a connection of the product unit with a complementary Aus hereatti.
  • the conversion device then has preference a nut threadedly disposed with respect to the product container and having an internal thread threadingly engaged with the male thread of the piston rod; and - a member rotatable relative to the threaded nut, to which the piston rod is non-rotatably and longitudinally displaceably connected and which has at least one engagement structure to transmit the drive rotary motion to the piston rod.
  • this unit may also comprise: a rotatable coupling output member having at least one engagement structure for transmitting drive rotational movement to the clutch output member; a one-way clutch is formed between the clutch output member and the rotatable member to permit drive rotation from the clutch output member to the rotatable member but to prevent a rotational movement of the rotatable member in a direction opposite to the drive rotational movement direction.
  • the connecting element preferably comprises at least one (preferably radially projecting) guide pin, which is designed to be guided in a curved path of a Aus wellech.
  • FIG. 1 shows a central longitudinal section of an injection pen in the delivery state
  • FIG. 2 is a partial perspective view of the injection pen of FIG. 1; FIG.
  • FIG. 3 is an enlarged view of the proximal portion of the injection pen of FIG. 1;
  • FIG. 5 shows a perspective partial view of the injection pen in the disassembled state
  • Fig. 6 is a partial view of the Injetationspens in longitudinal section in a position in which the product unit has been rotated by about 34 ° with respect to the dispensing unit to remove the product unit from the dispensing unit;
  • FIG. 7 is a partial perspective view of the injection pen in the condition of FIG. 6;
  • FIG. Fig. 8 is a partial view of the Injetationspens in longitudinal section after rotation of the
  • FIG. 9 is a partial perspective view of the injection pen in the condition of FIG. 8; FIG.
  • Fig. I l is a partial perspective view of the Injetationspens in the state of Fig. 10;
  • FIG. 12 shows a central longitudinal section through a threaded nut element
  • Fig. 13 is a perspective view of the threaded nut member
  • Fig. 14 is a perspective view of a reverse rotation lock
  • Fig. 15 is a perspective view of a driving sleeve
  • Fig. 16 is a perspective view of a mechanism holder
  • Fig. 17 is another perspective view of the mechanism holder; such as
  • Fig. 18 is a perspective view of a distal coupling sleeve together with a coupling shaft.
  • an injection device which is referred to below as injection pen, is shown in different states.
  • the injection pen comprises a product unit 1 ("disposable module”) and a discharge unit 2 ("reusable module").
  • product unit 1 dispenser module
  • discharge unit 2 discharge unit 2
  • FIGS. 6 to 11 these units are shown in various states which occupy these units when the product unit and the discharge unit are connected to each other or detached from each other.
  • the injection pen serves to deliver a drug to a patient through a needle 201 which is attached centrally by means of a needle adapter to the front end of the pen (on the left in Fig. 1).
  • the direction in which the needle points and into which the medicament is administered subsequently defines the distal direction, while the opposite direction is referred to below as the proximal direction.
  • the product unit 1 is arranged in the distal region of the injection pen. It comprises a container holder, referred to as container sleeve 110, in which a product container
  • the container sleeve 1 10 has a circular cylindrical main portion 114 which surrounds the product container 120 radially at least partially and which may have an unillustrated viewing window for controlling the contents of the product container.
  • the product unit 1 furthermore comprises a threaded rod 150, which is provided at its distal end with a feed flange 151 which is rotatably and axially fixedly connected to the threaded rod 150.
  • This threaded rod 150 serves as a feed element or piston rod for advancing the plug 121 and thus for expelling the drug from the product container 120th
  • the threaded rod 150 is held in a threaded nut 130, which is shown alone in Figures 12 and 13. As will be seen below, this nut performs a variety of different tasks.
  • the threaded nut 130 is secured with its sleeve-like distal end portion 131 at least 29iebegeschreibt, preferably also rotationally fixed, in the proximal end portion 1 12 of the container sleeve 110 fixed, as for example can be seen in Fig. 3.
  • the threaded nut Via an inner holding section 132 (FIG. 12) with internal thread 133, the threaded nut is in engagement with the external thread of the rotatable threaded rod 150 and is thus connected to the threaded rod 150 via a screw connection.
  • the proximal guide structures 137 serve to prevent rotation of a mechanism holder 310 described below in more detail (FIGS. 16 and 17) when the product unit is connected to the dispensing unit.
  • the inlet slopes at the proximal end of these radially projecting structures serve as joining aids for the rotational positioning when connecting the product unit to the dispensing unit.
  • the distal guide structures 138 act as snappers and serve as axial securing for a distal coupling sleeve 140 to be described later, when the product unit has been removed from the dispensing unit. This axial securing prevents the distal coupling sleeve 140 from coming out of engagement with the threaded nut 130. This is important because the threaded rod 150 is to remain against rotation when the product unit is removed.
  • the guide structures 138 are deflected radially by the mechanism holder 310 (FIGS. 16 and 17).
  • the distal coupling sleeve 140 is clearly recognizable, in particular in FIGS. 3 and 4, and is illustrated in more detail in FIG. It has, starting from its proximal end, three sections 143, 144, 145, each with a cylindrical outer lateral surface, the respective subsequent section each having a slightly smaller outer diameter in the distal direction. At its distal end, the sleeve has an end Schrägverrien 142 on.
  • the distal coupling sleeve 140 is relative to the threaded nut 130 within longitudinally displaceable within a certain range and is rotatable as long as the product unit is connected to the dispensing unit.
  • a rotatable element in the form of a reverse rotation lock 160 which is shown alone in FIG.
  • the reverse rotation lock 160 has a sleeve-like main portion 161, on the inner circumferential surface of which two longitudinal ribs 162 are formed. These engage in two complementary longitudinal grooves 152 of the threaded rod 150, which can be seen in particular in Figure 5.
  • the main section 161 has an external toothing 163 which is designed to cooperate with the internal toothing 135 of the threaded nut 130 in a rotationally fixed manner (see FIG.
  • the main section 161 On its proximal end side, the main section 161 also has an end helical toothing 164 which cooperates with the complementary helical toothing 142 of the distal coupling sleeve 140 (see FIG.
  • the two helical gears 142, 164 form a one-way clutch Kl (see Fig. 3), whose function will be explained in more detail below.
  • a spring portion 165 To the main portion 161 adjoins in the distal direction, a spring portion 165 which is integrally formed with the main portion 161 as a helical spring.
  • the spring portion 156 By the spring portion 156 abuts with its distal ends on the holding portion 132 of the threaded nut 130, the spring portion acts as a compression spring, which loads the reverse rotation lock 160 in the proximal direction when it is pressed within the threaded nut 130 in the distal direction.
  • the reverse rotation lock 160 When the reverse rotation lock 160 is pressed in this manner relative to the threaded nut 130 in the distal direction, the external teeth 163 out of engagement with the internal teeth 135 of the threaded nut, and the reverse rotation 160 is rotatable relative to the threaded nut 130.
  • This releasable toothing of reverse lock 160 and threaded nut 130 is referred to below as coupling K3 (see Fig. 3).
  • a dose limiting ring 170 which has an internal thread which is in engagement with the external thread of the threaded rod, and in its outer circumferential surface has longitudinal grooves which are in complementary longitudinal ribs 147 engage on the inner circumferential surface of the distal coupling sleeve 140, as can be seen in Fig. 18. The function of this dose-limiting ring 170 will be explained below.
  • the entire product unit consisting of container sleeve 1 10, product container 120, threaded nut 130, distal coupling sleeve 140, threaded rod 150, reverse rotation 160 and dose limiting ring 170 can be completely removed by a simple movement of the Ausschutinheit 2 and thus can easily completely against a new product unit to be replaced when the product container has been emptied.
  • the dispensing unit 2 comprises a housing 210, which is shown only in FIGS. 1 and 3 and has been omitted in the remaining views in order to improve the clarity.
  • the housing consists of a cylindrical, sleeve-like front (distal) housing portion 21 1, in which a viewing window 212 is inserted, to allow the reading of the set dose.
  • the sections 211 and 213 are manufactured as separate parts and subsequently connected; but they can also be made in one piece.
  • a mechanism holder 310 is rigidly connected to the housing and extends into the interior of the housing.
  • the mechanism holder is shown alone in FIGS. 16 and 17. It comprises a distal sleeve-shaped region 311 which is inserted into the housing 210 and to which a proximal region 314 of smaller diameter adjoins.
  • a proximal region of the mechanism holder extends radially spaced from the housing and has 35 in this area an external thread 315 on.
  • On the external thread 315 runs a display drum 330 with a corresponding internal thread, on the outside of which not graphically illustrated numerals are applied to display the set dose. These can be read through the window 212.
  • the display drum 330 is clearly visible particularly in the perspective views of Figures 2, 5, 7, 9 and 11.
  • first and second cam tracks 312, 312 ', 313 and 313' are formed in the distal sleeve-shaped region 311 of the mechanism holder 310 in the distal sleeve-shaped region 311 of the mechanism holder 310. These curved paths are clearly visible in particular in FIGS. 16 and 17.
  • bayonet sleeve 320 In the closed first cam tracks 312, 312 'a bayonet sleeve 320 is guided, which has for this purpose on its outer side two guide pins 321 which engage in the cam tracks 312, 312'. As a result, the bayonet sleeve 320 is forcibly guided along the cam track 312. This is e.g. clearly visible in FIG. 2.
  • the bayonet sleeve 320 has an inner diameter which is larger than the outer diameter of the proximal portion of the threaded nut 130 and thereby allows the threaded rod 150 and the threaded nut 130 of the product unit 1 to be partially inserted into the bayonet sleeve.
  • the container sleeve 110 also has at its proximal end two guide pins 113 (see, e.g., Fig. 5) adapted to engage the two open second cam tracks 313, 313 '.
  • the product unit 1 can be in the manner of a bayonet lock with the Aus thoroughlytician 2 connect and lock by the container sleeve 1 10 is first inserted axially into the mechanism holder 310 and then due to the positive guidance of their guide pins 113 in the cam tracks 313, 313 'a combined Rotary and translational movement by 90 °.
  • the first and second curved paths run parallel to each other, while in their distal region, the first cam tracks 312, 312 'relative to the second cam tracks 313, 313' have different slopes.
  • the second cam tracks 313, 313 'in this area are steeper with respect to the longitudinal axis than the cam tracks 312, 312'.
  • the container sleeve 1 10 rotates due to its positive engagement with the bayonet sleeve 320, the bayonet sleeve and thereby forces them to move along their own curved path 312, 312th '.
  • the entire product unit 1 is moved relative to the dispensing unit 2 in the proximal direction.
  • the distal coupling sleeve 140 engages with a proximal coupling sleeve 251 of a drive device, as will be described below.
  • the drive device is completely housed in the Aus thoroughlytician 2. It comprises a coupling shaft 250, which can be seen particularly well in FIG.
  • This coupling shaft includes a central, axially proximal portion 256 which terminates in a disc-shaped radial flange 253. From this radial flange, an inner, relatively long proximal coupling sleeve 251 extends axially in the distal direction. Radially spaced from the proximal coupling sleeve 251 extends a relatively shorter support sleeve 252 larger diameter on which a transmission sleeve 270 is pushed and rigidly connected thereto.
  • a coil spring 261 mounted on the proximal portion 256 of the coupling shaft 250 is a coil spring 261 whose spiral axis coincides with the longitudinal direction of the injection pin and defines an axis of rotation D (see Fig. 1). This is connected with its outer end with a relative to the housing rotatably fixed spring sleeve 260. Proximal then to the coil spring 261, a clutch disc 240 is rigidly mounted on the clutch shaft. Finally, on the proximal end of the coupling shaft 250, a release button 230 Ag.
  • a Dosierknopf 220 is rotatably and slidably pushed onto the rear housing portion 213.
  • the dosing button can be rotated in discrete steps both clockwise and anticlockwise relative to the housing 210 via a double slip clutch.
  • the double slip clutch is provided by an inner ring 212 which is rotatable and displaceable relative to the metering knob 220, one or more ratchet springs 222 acting in the axial direction, a ratchet ring 290 with helical front teeth on its distal end side and a corresponding helical end toothing on the proximal end of the rear housing section 213 educated.
  • the helical gears are sawtoothed to allow stepwise rotation both clockwise and counterclockwise.
  • the dosing knob 220 engages the clutch disc 240 via the inner ring 221.
  • an external toothing of the clutch disc which is in engagement with an internal toothing of the inner ring.
  • These teeth form a coupling K4, which is releasable by a movement of the clutch disc 240 in the distal direction.
  • the clutch plate 240 which also turns the entire clutch shaft 250 rotates.
  • the spring sleeve 260 which is rotationally fixed relative to the housing, remains stationary, so that upon rotation of the metering knob 220, the coil spring 261 is tensioned accordingly.
  • the coupling shaft 250 also takes over the support sleeve 252 with the transmission sleeve 270, which stands on longitudinal ribs on its outer surface in a rotationally fixed, but longitudinally displaceable connection with longitudinal grooves in the inner circumferential surface of the proximal end portion of the display drum 330.
  • This will do the Display drum 330 a screw movement relative to the mechanism holder 310, so that the numerical values applied to the display drum 330 in a helical arrangement walk under the window 212, can be read through it and so indicate the currently set dose.
  • the coupling shaft 250 also carries the distal coupling sleeve of the product unit 1 via the proximal coupling sleeve 251 and the coupling K5.
  • the threaded rod 150 is thereby decoupled by the Einwegloiskupplung Kl between the distal coupling sleeve 140 and the reverse rotation 160 of this rotation and additionally secured by the coupling K3 between the reverse rotation lock 160 and the threaded nut 130 against rotation.
  • the trigger button 230 is pressed in the distal direction into the dosing button 220.
  • the trigger button 230 pushes the clutch disc 240 in the distal direction.
  • the entire coupling shaft 250 is displaced in the distal direction and thereby takes over the coupling K5 and the distal coupling sleeve 140 in the distal direction with.
  • This in turn gets over the clutch Kl with the reverse rotation lock 160 engages and presses the reverse rotation lock 160 against the restoring force of the spring portions 165 also in the distal direction.
  • a central clutch spring 280 in the form of a helical spring is compressed via the transmission sleeve 270 and thereby tensioned.
  • the clutch spring 280 is connected at its distal end to a bearing ring 300, which is rotatably mounted on the mechanism holder 310 via a bearing, preferably a ball bearing.
  • the clutch Kl is closed, and the clutches K3 and K4 are opened.
  • the clutch K1 between the distal coupling sleeve 140 and the reverse rotation lock 160 is closed.
  • the coupling K3 between reverse rotation lock 160 and threaded nut 130 is opened.
  • the coupling Clutch K4 between the clutch disc 240 and dosing 220 which holds the torque of the coil spring 261, from.
  • other coupling ways are possible.
  • the coil spring 261 is released and generates with the elastic energy stored in it a torque on the clutch shaft 250th
  • This torque is transmitted via the clutch K5 on the distal coupling sleeve 140 and from there via the clutch Kl on the reverse rotation 160 transmitted.
  • the reverse rotation lock 160 in turn transmits over its inner longitudinal ribs 162, the torque on the threaded rod 150, whereby it is rotated relative to the threaded nut 130 in a rotation. Due to the threaded engagement of the threaded rod 150 with the threaded nut 130, this rotation results in a helical advancement movement of the threaded rod in the distal direction and thus advancement of the plug 121 in the container 120 and expulsion of the medicament.
  • the bearing of the rotating parts of the mechanism with respect to the housing 210 is carried out ultimately via the ball bearing between the mechanism holder 310 and bearing ring 300th
  • the push button 230 remains rotationally fixed.
  • a click element 232 is loaded in the direction of the clutch disc via a spring 231, which jumps over frontal projections of the clutch disc 240 away and thereby generates a characteristic clicking sound.
  • the user can determine the already administered dose.
  • the display drum 330 is in turn taken over the driving sleeve 270, so that the indicated dose runs back to the value zero in the course of administration.
  • Dose limiting ring The function of the dose-limiting ring 170, which can be seen in FIG. 3, will be explained below.
  • This dose-limiting ring engages longitudinal grooves on the outside of the distal coupling sleeve 140.
  • the distal coupling sleeve 140 rotates relative to the threaded rod 150, thereby threading the dose-limiting ring 170 on the threaded rod in the proximal direction while the coupling sleeve 140 performs a rotational movement relative to the housing during the dispensing operation together with the threaded rod 150, so that the dose-limiting ring 170 retains its position during the dispensing operation relative to the threaded rod.
  • the position of the dose limiting ring 170 on the threaded rod 150 is thus a direct measure of the cumulative total set since the onset of the product unit dose.
  • the dose-limiting ring abuts a tangential stop at the proximal end of the threaded rod, thus preventing a dose exceeding the available residual dose in the product container.
  • This function of the dose-limiting ring is likewise explained in more detail in the already mentioned WO 2008/031235, and reference is again made in this regard to this document.
  • the bayonet sleeve 320 Due to the rotation of the bayonet sleeve 320 and the pin connection to the mechanism holder 130, the bayonet sleeve also moves in the distal direction.
  • the bayonet sleeve 320 axially engages the distal end of a long drive sleeve 340, shown alone in FIG.
  • the driving sleeve 340 has four snap hooks 342 at its distal end.
  • the drive sleeve 340 extends in the longitudinal direction through the mechanism holder 310 through to the transmission sleeve 270. About a radially projecting annular bead 341, the drive sleeve pulls the transmission sleeve 270 also in the distal direction.
  • clutches K2 remains engaged in this process, however, so that the threaded rod 150 against the container sleeve 110 rotatably and accidentally any remaining product in the container product can be distributed.
  • clutch K3 engages.
  • D 1 between bayonet sleeve 320 and threaded nut 130; D2 between bayonet sleeve 320 and mechanism holder 310; D3 between trigger button 230 and dosing button 220; and D4 between dosing knob 220 and housing 210.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif d'administration qui est conçu comme un appareil semi-jetable et peut être réalisé notamment sous forme de stylo d'injection. Ledit appareil comprend une unité de déversement (2) à usage multiple, pourvue d'un dispositif d'entraînement pour générer un mouvement rotatif d'entraînement, un récipient de produit (120), une tige de piston (150) et un dispositif de conversion (130, 140, 160) pour convertir le mouvement rotatif d'entraînement en un mouvement d'avance de la tige de piston (150). Le récipient de produit, la tige de piston et le dispositif de conversion forment ensemble, selon l'invention, une unité de produit (1). Celle-ci est fixée amovible à l'unité de déversement de manière telle que l'unité de produit dans sa totalité, donc avec la tige de piston et le dispositif de conversion, peut être enlevée de l'unité de déversement.
PCT/CH2010/000058 2009-03-20 2010-03-05 Dispositif d'administration à unité de produit interchangeable WO2010105376A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH430/09 2009-03-20
CH00430/09A CH700643A1 (de) 2009-03-20 2009-03-20 Verabreichungsvorrichtung mit auswechselbarer Produkteinheit.

Publications (1)

Publication Number Publication Date
WO2010105376A1 true WO2010105376A1 (fr) 2010-09-23

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Application Number Title Priority Date Filing Date
PCT/CH2010/000058 WO2010105376A1 (fr) 2009-03-20 2010-03-05 Dispositif d'administration à unité de produit interchangeable

Country Status (2)

Country Link
CH (1) CH700643A1 (fr)
WO (1) WO2010105376A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8834449B2 (en) 2012-01-23 2014-09-16 Ikomed Technologies, Inc. Mixing syringe
EP2829292A1 (fr) * 2013-07-22 2015-01-28 TecPharma Licensing AG Dispositif d'entraînement et de dosage comprenant un élément de limitation pour empêcher le réglage d'une dose plus grande que disponible
EP2881131A1 (fr) * 2013-12-05 2015-06-10 TecPharma Licensing AG Dispositif d'entraînement et de dosage pour un dispositif d'injection doté d'un ressort d'entraînement précontraint
US9751056B2 (en) 2012-01-23 2017-09-05 Merit Medical Systems, Inc. Mixing syringe

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US4978335A (en) * 1989-09-29 1990-12-18 Medex, Inc. Infusion pump with bar code input to computer
WO1997017095A1 (fr) 1995-11-09 1997-05-15 Disetronic Licensing Ag Dispositif d'injection contenant un medicament liquide
FR2770136A1 (fr) * 1997-10-27 1999-04-30 Njc Innovations Dispositif d'administration de substances therapeutiques a seringue motorisee
WO1999038554A1 (fr) * 1998-01-30 1999-08-05 Novo Nordisk A/S Seringue d'injection
EP0980687A1 (fr) * 1998-08-20 2000-02-23 Sooil Development Co., Ltd. Pousse seringue portatif
WO2003011372A2 (fr) 2001-07-30 2003-02-13 Tecpharma Licensing Ag Module de reservoir muni d'une tige de piston
US20040260303A1 (en) * 2003-06-17 2004-12-23 Carrison Harold F. Apparatus and methods for delivering compounds into vertebrae for vertebroplasty
WO2008031235A1 (fr) 2006-09-15 2008-03-20 Tecpharma Licensing Ag Appareil d'injection à entraînement à faibles pertes

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4978335A (en) * 1989-09-29 1990-12-18 Medex, Inc. Infusion pump with bar code input to computer
WO1997017095A1 (fr) 1995-11-09 1997-05-15 Disetronic Licensing Ag Dispositif d'injection contenant un medicament liquide
FR2770136A1 (fr) * 1997-10-27 1999-04-30 Njc Innovations Dispositif d'administration de substances therapeutiques a seringue motorisee
WO1999038554A1 (fr) * 1998-01-30 1999-08-05 Novo Nordisk A/S Seringue d'injection
EP0980687A1 (fr) * 1998-08-20 2000-02-23 Sooil Development Co., Ltd. Pousse seringue portatif
WO2003011372A2 (fr) 2001-07-30 2003-02-13 Tecpharma Licensing Ag Module de reservoir muni d'une tige de piston
US20040260303A1 (en) * 2003-06-17 2004-12-23 Carrison Harold F. Apparatus and methods for delivering compounds into vertebrae for vertebroplasty
WO2008031235A1 (fr) 2006-09-15 2008-03-20 Tecpharma Licensing Ag Appareil d'injection à entraînement à faibles pertes

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9751056B2 (en) 2012-01-23 2017-09-05 Merit Medical Systems, Inc. Mixing syringe
US8834449B2 (en) 2012-01-23 2014-09-16 Ikomed Technologies, Inc. Mixing syringe
US10143806B2 (en) 2013-07-22 2018-12-04 Tecpharma Licensing Ag Drive and dosing device with a stop element for preventing the setting of a dose
CN105407945A (zh) * 2013-07-22 2016-03-16 特克法马许可公司 具有用于防止设置剂量的止动元件的驱动与定量装置
US20160129196A1 (en) * 2013-07-22 2016-05-12 Tecpharma Licensing Ag Drive and dosing device with a stop element for preventing the setting of a dose
WO2015010215A1 (fr) * 2013-07-22 2015-01-29 Tecpharma Licensing Ag Dispositif d'entraînement et de dosage pourvu d'un élément d'arrêt pour empêcher le réglage d'une dose
EP2829292A1 (fr) * 2013-07-22 2015-01-28 TecPharma Licensing AG Dispositif d'entraînement et de dosage comprenant un élément de limitation pour empêcher le réglage d'une dose plus grande que disponible
CN105407945B (zh) * 2013-07-22 2019-01-04 特克法马许可公司 具有用于防止设置剂量的止动元件的驱动与定量装置
US10980947B2 (en) 2013-07-22 2021-04-20 Ypsomed Ag Drive and dosing device with a stop element for preventing the setting of a dose
EP2881131A1 (fr) * 2013-12-05 2015-06-10 TecPharma Licensing AG Dispositif d'entraînement et de dosage pour un dispositif d'injection doté d'un ressort d'entraînement précontraint
WO2015081451A1 (fr) * 2013-12-05 2015-06-11 Tecpharma Licensing Ag Dispositif de dosage et d'entraînement pour un dispositif d'injection à ressort d'entraînement précontraint
CN106029130A (zh) * 2013-12-05 2016-10-12 特克法马许可公司 用于注射装置的带有预紧的驱动弹簧的驱动和配量装置
US10603443B2 (en) 2013-12-05 2020-03-31 Tecpharma Licensing Ag Driving and dosing device for an injection device with a pretensioned driving spring
CN106029130B (zh) * 2013-12-05 2020-05-29 特克法马许可公司 用于注射装置的带有预紧的驱动弹簧的驱动和配量装置

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