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WO2017108558A1 - Dispositif injecteur destiné à faciliter l'assemblage d'une unité d'injection - Google Patents

Dispositif injecteur destiné à faciliter l'assemblage d'une unité d'injection Download PDF

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Publication number
WO2017108558A1
WO2017108558A1 PCT/EP2016/081126 EP2016081126W WO2017108558A1 WO 2017108558 A1 WO2017108558 A1 WO 2017108558A1 EP 2016081126 W EP2016081126 W EP 2016081126W WO 2017108558 A1 WO2017108558 A1 WO 2017108558A1
Authority
WO
WIPO (PCT)
Prior art keywords
injector
force
motor
unit
injector part
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2016/081126
Other languages
English (en)
Inventor
Christian FISHLEIN
Jan Olesen
Esben W. Johansen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Phillips Medisize AS
Original Assignee
Medicom Innovation Partner AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medicom Innovation Partner AS filed Critical Medicom Innovation Partner AS
Publication of WO2017108558A1 publication Critical patent/WO2017108558A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2065—Connecting means having aligning and guiding means
    • 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
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/14216—Reciprocating piston 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
    • 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
    • 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
    • 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
    • A61M2207/00—Methods of manufacture, assembly or production
    • 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
    • A61M2207/00—Methods of manufacture, assembly or production
    • A61M2207/10—Device therefor

Definitions

  • the present invention relates to an injector device for preparing and delivering a drug.
  • the injector device of the invention is capable of assisting a user in assembling a disposable injector unit accommodated in the injector device.
  • injector devices it is necessary to assemble several separate parts, such as a syringe, a vial, an injection needle, mixing equipment, etc., in order to be able to properly handle preparation and administration of the medical drug.
  • Such assembly is normally handled manually by the user. This introduces the risk of errors occurring, e.g. in the form of leaks in the assembled injector device or blocked passages, thereby resulting in medical drug being mixed in an erroneous manner and/or incorrect doses of medical drug being delivered.
  • an injector device for preparing and delivering a medical drug the injector device being capable of assisting a user in assembling an injector unit accommodated in the injector device. It is an even further object of embodiments of the invention to provide a method for assembling at least two injector parts of an injector unit, in which the risk of introducing errors is reduces as compared to prior art methods.
  • the invention provides an injector device for preparing and delivering a medical drug, the injector device comprising:
  • a housing defining a cavity arranged to receive a disposable injector unit
  • disposable injector unit being assembled from at least two separate injector parts, - at least one motor arranged inside the housing,
  • a holding mechanism arranged to fixate a first injector part of the disposable injector unit
  • a force transferring mechanism arranged to transfer a linear force and/or a torque from the motor to a second injector part of the disposable injector unit, thereby causing the second injector part to perform translational and/or rotational movements relative to the first injector part, thereby causing the first injector part and the second injector part to be assembled.
  • the invention provides an injector device for preparing and delivering a medical drug.
  • the term 'injector device' should be interpreted to mean a device being adapted to deliver a dose of medical drug to a user by means of injection.
  • the injector device of the invention is further adapted to prepare the medical drug being delivered, e.g. by mixing or reconstituting the medical drug.
  • the injector device comprises a housing defining a cavity.
  • the term 'housing' should be interpreted to mean a substantially closed part which defines a cavity in an interior part thereof, the cavity being able to accommodate various parts being relevant with respect to preparing and delivering the medical drug.
  • the housing substantially encloses parts being accommodated in the cavity.
  • the cavity of the housing is arranged to receive a disposable injector unit, which is assembled from at least two separate parts.
  • the separate parts could, e.g., include a syringe, a vial, an injection needle, a mixing unit and/or any other suitable part.
  • the disposable injector unit is a unit which contains the medical drug to be delivered and parts required in order to handle the medical drug during preparation and delivery.
  • the medical drug contained in the disposable injector unit could, e.g., be in the form of two or more ingredients which need to be mixed or reconstituted during preparation.
  • the medical drug may be contained only in a vial which can be connected to the disposable injector unit, or which forms part of the disposable injector unit.
  • the disposable injector unit can be positioned in the cavity of the housing of the injector device, used for preparing and delivering the medical drug, and will normally be removed from the cavity and disposed of once the delivery of the medical drug has been completed.
  • the injector device as such, including the housing can be reused for preparing and delivering a new dose of medical drug, using a new disposable injector unit.
  • the injector device further comprises at least one motor arranged inside the housing, e.g. inside the cavity which also accommodates the disposable injector unit.
  • the injector device comprises a holding mechanism arranged to fixate a first injector part of the disposable injector unit.
  • the holding mechanism is capable of engaging the first injector part in such a manner that the first injector part is prevented from performing certain movements with respect to the injector device, notably with respect to the housing.
  • the holding mechanism may prevent the first injector part from performing unintentional translational and/or rotational movements.
  • the injector device comprises a force transferring mechanism arranged to transfer a linear force and/or a torque from the motor to a second injector part of the disposable injector unit.
  • the motor can cause the second injector part to perform translational and/or rotational movements, via the force transferring mechanism. Since the first injector part is fixated by means of the holding mechanism, the second injector part can thereby be caused to perform translational and/or rotational movements relative to the first injector part.
  • the first injector part and the second injector part can be assembled while being accommodated inside the cavity of the housing of the injector device, and using the motor, the holding mechanism and the force transferring mechanism.
  • the injector device either handles the assembly of the injector parts in a completely automatic manner, or the injector device assists the user during the assembly of the injector parts.
  • the injector device may, e.g., be ensured that the first injector part and the second injector part are properly aligned with respect to each other, that an appropriate force or torque is applied, that the connection between the injector parts is properly sealed, etc. Accordingly, the risk of errors arising during the assembly of the first injector part and the second injector part is minimised.
  • the holding mechanism may further be arranged to transfer a counter-force to the first injector part, the counter-force being adapted to counteract the linear force and/or torque being transferred to the second injector part by the force transferring mechanism.
  • the holding mechanism is not merely arranged to fixate the first injector part, but is also capable of providing a counter-force which counteracts the movements of the second injector part as a result of a linear force and/or a torque being transferred to the second injector part from the motor, via the force transferring mechanism.
  • the first injector part will not only remain immovable, but will perform a movement which is similar to, but directed in an opposite direction, as compared to the movement of the second injector part. This will allow the assembly of the first injector part and the second injector part to be performed fast and accurately.
  • the holding mechanism may simply keep the first injector part immovable with respect to the housing.
  • the first injector part and the second injector part may be assembled via a Luer connection or a Luer lock connection.
  • a Luer connection is a connection in which a male tapered connector, formed on one part, is fitted with a corresponding female tapered connector, formed on another part.
  • the male tapered connector and the female tapered connector are fitted to each other by moving them towards each other by means of a relative translational movement.
  • the tapered shape ensures a fluid tight connection between the two parts having the male and the female tapered connectors formed thereon.
  • the force transferring mechanism must be arranged to transfer a linear force from the motor to the second injector part, in order to provide the relative translational movement between the first injector part and the second injector part, thereby causing the first injector part and the second injector part to be assembled via the Luer connection.
  • a Luer lock connection is similar to a Luer connection, in the sense that it includes a male tapered connector formed on one part and a corresponding female tapered connector formed on another part.
  • the tapered connectors are further provided with threaded parts. Accordingly, the connectors are, in this case, fitted to each other by means of relative movements which include translational movements as well as rotational movements.
  • the force transferring mechanism must be arranged to transfer a linear force as well as a torque from the motor to the second injector part, in order to provide the required relative movement between the first injector part and the second injector part, thereby causing the first injector part and the second injector part to be assembled via the Luer lock connection.
  • the linear force and the torque may be provided by the same motor, or the linear force and the torque may be provided by two separate motors.
  • first injector part and the second injector part may be assembled via any other suitable kind of connection.
  • the force transferring mechanism may comprise one or more protruding parts arranged to engage with one or more recesses formed on the second injector part.
  • the linear force and/or the torque is transferred from the motor to the second injector part due to cooperation between the one or more protruding parts and the one or more recesses.
  • the second injector part may be arranged in contact with the force transferring mechanism in such a manner that the one or more protruding parts of the force transferring mechanism are engaging the one or more recesses of the second injector part.
  • the motor may then cause the one or more protruding parts to perform relevant movements, and these relevant movements are transferred to the second injector part, via the connection between the protruding parts and the recesses.
  • the one or more recesses could, e.g., be in the form of ribs formed on the second injector part, such as standard ribs formed on a male Luer lock nut.
  • the force transferring mechanism may comprise a ratchet mechanism.
  • the one or more protruding parts comprises one or more ratchet arms or the like being arranged to engage one or more recesses formed on the second injector part.
  • Yatchet mechanism' should be interpreted to mean a mechanism which allows relative movements between the first injector part and the second injector part along a first direction, but prevents such relative movements along a second direction being opposite to the first direction.
  • the ratchet mechanism could, e.g., comprise a pulling Geneva wheel or a pushing Geneva wheel.
  • the Geneva wheel may be provided with a number of ratchet arms arranged on a rotatable part, the ratchet arms being arranged to sequentially engage with recesses formed on the second injector part, e.g. in the form of ribs formed on a male Luer lock nut, as the Geneva wheel rotates.
  • the ratchet mechanism could, e.g., comprise an eccentric mechanism driving movements of one or more ratchet arms arranged to engage one or more recesses formed on the second injector part.
  • the ratchet mechanism could, e.g., comprise two ratchet arms connected to a gear wheel, the two ratchet arms being arranged to alternatingly engage recesses formed on the second injector part, in such a manner that, at any time, one of the ratchet arms pushes or pulls the second injector part, while the other ratchet arm moves from one recess to another.
  • the ratchet mechanism may comprise two or more ratchet arms.
  • the engaging portions of the ratchet may potentially be prepared with sharp edges and/or may potentially be manufactured in a metal alloy, thereby better securing robust engagement even with slippery and/or wet surfaces, and/or polymers with smooth surfaces.
  • the ratchet(s) may be formed from a material which is harder than the material used for the second injector part. This will allow the ratchet(s) to cut into a surface of the second injector part, deforming a part of surface, thereby providing a secure grip between the ratchet(s) and the second injector part.
  • a tip of the ratchet(s) may be designed in such a manner that a sharp interface is defined between the ratchet(s) and the second injector part. This also allows the ratchet(s) to cut into the surface of the second injector part, deforming a part of the surface, thereby providing a secure grip.
  • the ratchet mechanism could, e.g., be connected to the motor via one or more gear wheels.
  • the protruding parts and the recesses may be provided by means of meshing gear wheels formed on or connected to the force transferring mechanism and the second injector part, respectively.
  • the force transferring mechanism may comprise a belt drive comprising an endless belt having protruding parts formed thereon. The protruding parts of the belt may then engage recesses formed on the second injector part.
  • protruding parts could, alternatively, be formed on the second injector part, while the recesses are formed on the force transferring mechanism.
  • the remarks set forth above are equally applicable in this case.
  • the force transferring mechanism may be arranged to transfer forces to the second injector part by means of friction.
  • the force transferring mechanism may, e.g., comprise one or more drive wheels arranged in contact with the second injector part.
  • the force transferring mechanism may comprise a gripping mechanism arranged to grip the second injector part, e.g. in order to transfer a translational force to the second injector part.
  • the gripping mechanism may transfer the linear force or torque purely by means of friction, or it could be provided with parts which are able to cut into a portion of the second injector part in order to provide a firmer grip.
  • a motor current of the motor may be indicative of a tensioning force of the assembly between the first injector part and the second injector part.
  • the motor moves the second injector part relatively to the first injector part, via the force transferring mechanism, in order to assemble the first injector part and the second injector part, it must be expected that the assembly of or connection between the first injector part and the second injector part becomes increasingly tightened. Thereby the movement of the motor is met with increasing resistance, and this increasing resistance affects the motor current of the motor.
  • the motor current of the motor provides an appropriate measure for the tensioning of the assembly between the first injector part and the second injector part, i.e. for how tightly the first injector part and the second injector part have been connected to each other.
  • the holding mechanism may be arranged to fixate the first injector part by means of friction.
  • the holding mechanism may comprise a gripping mechanism arranged to grip the first injector part, or drive wheels arranged in contact with the first injector part, e.g.
  • the holding mechanism may comprise mating parts formed on the holding mechanism and the first injector part, respectively, the mating parts being arranged to engage, thereby fixing the first injector part.
  • the mating parts could, e.g., be in the form of mating gear wheels, a spline connection, protruding parts and recesses, etc.
  • the injector parts of the injector unit may include at least a syringe and a vial adapter. According to this embodiment, assembly of the syringe and the vial adapter may be performed by or assisted by the motor, the force transferring mechanism and the holding mechanism, in the manner described above.
  • At least one of the at least one motors may be arranged for operating the disposable injector unit in order to cause medical drug to be prepared in and/or delivered from the injector device.
  • the injector device is further adapted to provide automatic or semi-automatic preparation and/or delivery of the medical drug. Thereby the risk of errors is further reduced.
  • the motor being used for operating the disposable injector unit in order to cause medical drug to be prepared and/or delivered may be the same motor which is connected to the force transferring mechanism, and which is thereby used during assembly of the first and second injector parts.
  • the injector device may further comprise a clutch mechanism for selectively connecting the motor to the force transferring mechanism or to relevant parts of the disposable injector unit, in order to cause preparation or delivery of the medical drug.
  • separate motors may be applied for operating the force transferring mechanism and the disposable injector unit, respectively.
  • the invention provides a method for assembling at least two injector parts of a disposable injector unit, the method comprising the steps of: - arranging the at least two injector parts of the disposable injector unit in a housing of an injector device according to the first aspect of the invention, a first injector part being arranged in contact with a holding mechanism of the injector device and a second injector part being arranged in contact with a force transferring mechanism of the injector device, and - operating a motor of the injector device in order to transfer a linear force and/or a torque from the motor to the second injector part, via the force transferring mechanism, thereby causing the second injector part to perform translational and/or rotational movements relative to the first injector part, thereby assembling the first injector part and the second injector part.
  • the method according to the second aspect of the invention is a method for assembling at least two injector parts of a disposable injector unit, using an injector device according to the first aspect of the invention. Accordingly, the remarks set forth above with reference to the first aspect of the invention are equally applicable here. According to the method of the second aspect of the invention, the at least two injector parts to be assembled are initially arranged in a housing of an injector device according to the first aspect of the invention.
  • a first injector part is arranged in contact with a holding mechanism of the injector device, and a second injector part is arranged in contact with a force transferring mechanism of the injector device.
  • the first injector part can be fixed by means of the holding mechanism and the second injector part can be moved by means of the force transferring mechanism, in the manner described above with reference to the first aspect of the invention.
  • a motor of the injector device is operated in order to transfer a linear force and/or a torque from the motor to the second injector part, via the force transferring mechanism.
  • the second injector part is caused to perform translational and/or rotational movements relative to the first injector part, and the first and second injector parts are thereby assembled, in the manner described above with reference to the first aspect of the invention.
  • Figs, la and lb illustrate a disposable injector unit for use in an injector device according to an embodiment of the invention
  • Figs. 2-4 illustrate assembly of two injector parts according to an embodiment of the invention
  • Fig. 5 illustrates an injector device according to a first embodiment of the invention during assembly of two injector parts
  • Figs. 6-8 illustrate the injector device of Fig. 5 during preparation and delivery of medical drug
  • Figs. 9a and 9b illustrate an injector device according to a second embodiment of the invention
  • Figs. 10a and 10b illustrate an injector device according to a third embodiment of the invention
  • Fig. 11 is a perspective view of a force transferring mechanism comprising a ratchet mechanism
  • Figs. 12a-12c are perspective views of an alternative force transferring mechanism comprising a ratchet mechanism
  • Fig. 13 illustrates another alternative force transferring mechanism comprising a ratchet mechanism
  • Fig. 14 illustrates a force transferring mechanism comprising mating protruding parts and recesses
  • Figs. 15 and 16 illustrate various force transferring mechanisms comprising frictional connections
  • Figs. 17-19 illustrate various holding mechanisms comprising frictional connections.
  • Figs, la and lb illustrate a disposable injector unit 1 for use in an injector device according to an embodiment of the invention.
  • the disposable injector unit 1 comprises a syringe 2, a vial adapter and mixing unit 3, a vial 4, and a needle covered by a needle cover 5.
  • Fig. la the mixing unit 3, the vial 4 and the needle are assembled.
  • the syringe 2 is separated from the mixing unit 3.
  • Fig. lb the syringe 2 has been assembled with the mixing unit 3.
  • Fig. la illustrate the relative movements of the syringe 2 and the mixing unit 3 in order to assemble these two parts. Accordingly, the syringe 2 and the mixing unit 3 need to be moved linearly towards each other, and a relative rotational movement need to be provided. Thus, the syringe 2 and the mixing unit 3 may be connected to each other via a
  • Luer lock connection a female Luer lock connector 6 being formed on the mixing unit 3 and a male Luer lock connector comprising a Luer lock not 7 being formed on the syringe 2.
  • the relative linear movement may be provided by moving the syringe 2 as well as the mixing unit 3 linearly. Alternatively, only the syringe 2 may be moved linearly, while the mixing unit 3 is fixed, or only the mixing unit 3 may be moved linearly, while the syringe 2 is fixed.
  • the relative rotational movement may be provided by rotating the syringe 2 as well as the mixing unit 3 in opposite directions.
  • only the syringe 2 may be rotated, while the mixing unit 3 is fixed, or only the mixing unit may be rotated, while the syringe 2 is fixed.
  • only the Luer lock nut 7 may be rotated .
  • Figs. 2-4 illustrate assembly of two injector parts according to an embodiment of the invention.
  • Fig. 2 shows a syringe 2 comprising a syringe barrel 8 and a plunger 9 arranged slidably inside the syringe barrel 8.
  • a male Luer lock connector comprising a Luer lock nut 7 is arranged at a distal end of the syringe 2.
  • Fig. 3 shows a vial adapter and mixing unit 3 having a vial 4 and an injection needle 10, covered by a needle cover 5, connected thereto.
  • the mixing unit 3 is further provided with a female Luer lock connector 6.
  • the female Luer lock connector 6 of the mixing unit 3 shown in Fig. 3 and the male Luer lock connector of the syringe 2 shown in Fig. 2 can be connected, thereby assembling the syringe 2 and the mixing unit 3.
  • the syringe 2 and the mixing unit 3 form the two injector parts being assembled using an injector device according to the invention.
  • FIG. 2 and 3 illustrate how the syringe 2 and the mixing unit 3 need to be moved relative to each other in order to connect the female Luer lock connector 6 of the mixing unit 3 and the male Luer lock connector of the syringe 2.
  • the arrows further indicate positions along the syringe 2 and the mixing unit 3 in which a linear force, a torque or a holding force can be applied to the respective parts 2, 3 during assembly of the syringe 2 and the mixing unit 3.
  • a force and/or a torque may be applied to the plunger 9, to a finger flange 11 of the syringe barrel 8, to the syringe barrel 8 or to the Luer lock nut 7.
  • the force and/or the torque may be applied by means of friction and/or by engaging protruding parts and recesses.
  • a force and/or a torque may be applied to the female Luer lock connector 6 or the needle cover 5.
  • Fig. 4 shows the syringe 2 and the mixing unit 3 in an assembled state, as well as a perspective view of the Luer lock nut 7.
  • Fig. 5 illustrates an injector device 12 according to a first embodiment of the invention during assembly of two injector parts, in the form of a syringe 2 and a vial adapter and mixing unit 3.
  • the injector device 12 comprises a housing 13 defining a cavity in which the injector parts
  • the force transferring mechanism 18 is connected to motor 15 and to the syringe 2. Thereby the force transferring mechanism 18 is capable of transferring a linear force as well as a torque from the motor 15 to the syringe 2. Accordingly, by appropriately operating the motor 15, the syringe 2 can be caused to perform a translational movement towards the mixing unit
  • the mixing unit 3 is fixed by means of the holding mechanism 17, thereby ensuring that the linear force and the torque transferred from the motor 15 to the syringe 2, via the force transferring mechanism 18, results in relative movements between the syringe 2 and the mixing unit 3.
  • the injector device 12 assists the user in assembling the syringe 2 and the mixing unit 3. Thereby the risk of errors occurring during the assembly as well as during the subsequent preparation and delivery of medical drug from the injector device 12 is reduced. Furthermore, proper assembly of the syringe 2 and the mixing unit 3 is ensured, even if the user has reduced dexterity or vision, or suffers from other kinds of impairment.
  • Figs. 6-8 illustrate the injector device 12 of Fig. 5 during preparation and delivery of medical drug after the syringe 2 and the mixing unit 3 have been assembled as described above.
  • a linear force is transferred from motor 16 to the plunger 9 of the syringe 2, thereby causing a diluent contained in the syringe 2 to enter the vial 4.
  • a torque is transferred from motor 14 to the mixing unit 3, causing the vial 4 to be shaken, thereby mixing a medical drug contained in the vial 4 and the diluent which was supplied from the syringe 2, causing reconstitution of the medical drug.
  • FIG. 8 the plunger 9 has been moved as described above.
  • FIGs. 9a and 9b illustrate an injector device 12 according to a second embodiment of the invention.
  • the disposable injector unit does not comprise a mixing unit.
  • the injection needle 10 is mounted directly on the syringe 2, via a needle adapter 19.
  • Two motors 20, 21 are accommodated inside the housing 13 of the injector device 12.
  • Motor 20 is connected to a Luer lock nut 7 of the syringe 2, via a force transferring mechanism 22. Thereby a toque can be transferred from the motor 20 to the Luer lock nut 7, causing the Luer lock nut 7 to perform rotational movements.
  • Motor 21 is connected to a finger flange 11 formed on the syringe barrel 8, via a force transferring mechanism 23. Thereby a linear force can be transferred from the motor 21 to the finger flange 11, via the force transferring mechanism 23, causing the syringe 2 to perform linear movements.
  • the syringe 2 and the injection needle 10 are arranged inside the housing 13 of the injector device 12, in the manner shown in Fig. 9a. Then the motor 21 is operated in order to transfer a linear force to the finger flange 11, via the force transferring mechanism 23, thereby moving the syringe 2 in a distal direction towards the injection needle 10.
  • a part of the needle adapter 19 is positioned inside the Luer lock nut 7 of the syringe 2. This is illustrated in Fig. 9b.
  • the motor 20 is operated in order to transfer a torque from the motor 20 to the Luer lock nut 7, via the force transferring mechanism 22, thereby causing the Luer lock nut 7 to perform rotational movements relative to the needle adapter 19. Thereby the Luer lock connection is tightened.
  • medical drug contained in the syringe barrel 8 may be delivered by applying a linear force to the plunger 9 of the syringe 2. This could be performed manually or by means of an additional motor (not shown).
  • Figs. 10a and 10b illustrate an injector device 12 according to a third embodiment of the invention.
  • the injector device 12 of Figs. 10a and 10b is very similar to the injector device 12 of Figs. 9a and 9b, in that two motors 20, 21 are accommodated inside the housing 13 of the injector device 12, and that the motor 20 is connected to the Luer lock nut 7 via force transferring mechanism 22 and the motor 21 is connected to the finger flange 11 via force transferring mechanism 23.
  • the syringe 2 is, in this case, connected to a mixing unit 3 being provided with a female Luer lock connector 6.
  • the syringe 2 and the mixing unit 3 are assembled essentially in the manner described above with reference to Figs. 9a and 9b.
  • Fig. 11 is a perspective view of a force transferring mechanism 24 for use in an injector device according to an embodiment of the invention.
  • the force transferring mechanism 24 is arranged to transfer a torque from a motor (not shown) to a Luer lock nut 7, and it could be applied in any of the injector devices shown in Figs. 5-10b.
  • the force transferring mechanism 24 comprises a ratchet mechanism which will be described in further detail below.
  • the motor rotates a gear wheel 25 which engages a rotatable arch 26.
  • Two ratchet arms 27 are mounted on the rotatable arch 26 and can be arranged in engagement with recesses formed by ribs on the Luer lock nut 7. Rotational movements of the rotatable arch 26 thereby result in movements of the ratchet arms 27. This movement is transferred to the Luer lock nut 7 in the following manner.
  • the ratchet arms 27 engage the recesses formed on the Luer lock nut 7 in such a manner that, at any time, one of the ratchet arms 27 pushes against a side wall formed in a recess of the Luer lock nut 7, while the other ratchet arm 27 is out of engagement with such a side wall.
  • the engaging ratchet arm 27 thereby pushes the Luer lock nut 7, causing it to rotate and providing a relative movement between the Luer lock nut 7 and the other ratchet arm 27, causing the other ratchet arm 27 to be moved across a rib and into a recess of the Luer lock nut 7.
  • this ratchet arm 27 will be arranged in contact with a side wall of a recess, and will therefore push the Luer lock nut 7, while the first ratchet arm 27 is moved to the next recess.
  • Figs. 12a-12b are perspective views of an alternative force transferring mechanism 24 for use in an injector device according to an embodiment of the invention.
  • the force transferring mechanism 24 is similar to the force transferring mechanism 24 of Fig. 11, in that it comprises a ratchet mechanism and in that it is arranged to transfer a torque from a motor (not shown) to a Luer lock nut 7.
  • the force transferring mechanism 24 of Figs. 12a-12c could be applied in any of the injector devices shown in Figs. 5-10b.
  • the motor rotates a gear wheel 25 which engages a rotatable arch 26.
  • a ratchet arm 27 is mounted on the rotatable arch 26, and thereby movements of the gear wheel 25 are transferred to the ratchet arm 27, via the rotatable arch 26, essentially as described above with reference to Fig. 11.
  • the ratchet arm 27 is supported by a spring force or torque (not shown) which effectively forces the ratchet engagement edge in a direction towards the Luer lock nut 7.
  • the ratchet mechanism is in a position in which the ratchet arm 27 engages a side wall of a recess formed on the Luer lock nut 7.
  • Rotating the gear wheel 25 in a counterclockwise direction causes the rotatable arch 26 to rotate in a clockwise direction, thereby moving the ratchet arm 27 towards the left. Accordingly, the ratchet arm 27 pushes the Luer lock nut 7, causing it to rotate in a clockwise direction. This can continue as long as the ratchet arm 27 remains in contact with the side wall of the recess.
  • Rotating the gear wheel 25 in a clockwise direction causes the rotatable arch 26 to rotate in a counter-clockwise direction, thereby moving the ratchet arm 27 towards the right, thereby sliding over the Luer lock nut 7 ribs without rotating the Luer lock nut 7.
  • the reverse rotation may continue until a predefined angular rotation, e.g. similar as to the position in Fig. 12a is reached, or the reverse rotation may continue until the position shown in Fig. 12c is reached.
  • the ratchet arm 27 furthermore engages with a physical structure (not shown) to press the ratchet arm 27 out of engagement with the Luer lock nut 7, thereby overcoming the influence of spring loading to engage with the Luer lock nut 7. In this position the user may insert or remove the syringe from the injector.
  • Fig. 13 illustrates another alternative force transferring mechanism 24 for use in an injector device according to an embodiment of the invention.
  • the force transferring mechanism 24 of Fig. 13 also comprises a ratchet mechanism, and is also arranged to transfer a torque from a motor (not shown) to a Luer lock nut 7.
  • the force transferring mechanism 24 of Fig. 13 could be applied in any of the injector devices shown in Figs. 5-10b.
  • the force transferring mechanism 24 of Fig. 13 comprises a Geneva wheel 28 provided with three ratchet arms 27.
  • the Geneva wheel 28 is rotated by means of a motor (not shown).
  • the ratchet arm 27 which is arranged in engagement with the Luer lock nut 7 thereby pushes or pulls the Luer lock nut 7, causing it to perform rotational movements.
  • the next ratchet arm 27 will be rotated into engagement with the Luer lock nut 7, and the rotational movement of the Luer lock nut 7 can thereby be continued until it has been properly tightened.
  • Fig. 14 illustrates yet another alternative force transferring mechanism 24 for use in an injector device according to an embodiment of the invention.
  • the force transferring mechanism 24 of Fig. 14 is also arranged to transfer a torque from a motor (not shown) to a Luer lock nut 7.
  • the force transferring mechanism 24 could be applied in any of the injector devices shown in Figs. 5-10b.
  • the force transferring mechanism 24 of Fig. 14 comprises a belt drive with a continuous belt 29 mounted on two drive wheels 30.
  • the belt 29 is provided with a number of protruding parts 31 arranged to engage recesses formed on the Luer lock nut 7.
  • At least one of the drive wheels 30 is connected to the motor. Operating the motor thereby causes the drive wheels 30 to rotate, thereby driving the belt 29. Since the protruding parts 31 of the belt 29 are arranged in engagement with the Luer lock nut 7, this causes the Luer lock nut 7 to rotate.
  • Figs. 15 and 16 illustrate various force transferring mechanisms 24 comprising frictional connections.
  • a torque is transferred to a Luer lock nut 7 from a rotating drive wheel 32 by means of a frictional connection between the drive wheel 32 and the Luer lock nut 7.
  • the drive wheel 32 is rotated by a motor (not shown), and it is biased in a direction towards the Luer lock nut 7, e.g. by means of a spring (not shown), in order to provide a good frictional connection.
  • the force transferring mechanism 24 of Fig. 16 is similar to the force transferring mechanism 24 of Fig. 15. However, the force transferring mechanism 24 of Fig. 16 is provided with three drive wheels 32, each being rotated by means of a motor (not shown). This improves the frictional connection between the drive wheels 32 and the Luer lock nut 7. Since the three drive wheels 32 are distributed along the circumference of the part being fixed, it is not necessary to bias the drive wheels 32 towards the part.
  • Figs. 17-19 illustrate various holding mechanisms 33 comprising frictional connections.
  • the holding mechanisms 33 could, e.g., be used for fixating a substantially cylindrical part of a disposable injector unit, such as a syringe barrel.
  • the holding mechanisms 33 of Figs. 17-19 could be applied in any of the injector devices shown in Figs. 5-10b.
  • the holding mechanism 33 comprises grippers 34 arranged to grip the part to be fixated and to fixate the part by means of friction.
  • the holding mechanism 33 comprises a drive wheel 32, similarly to the force transferring mechanism of Fig. 15.
  • the holding mechanism 33 of Fig. 18 is arranged to provide a counter-force which counteracts a torque being transferred to another part which is to be assembled to the part which is fixed by means of the holding mechanism 33.
  • the holding mechanism 33 comprises three drive wheels 32, similarly to the force transferring mechanism of Fig. 16.
  • the holding mechanism 33 of Fig. 19 is also arranged to provide a counter-force.

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

Abstract

L'invention concerne un dispositif injecteur (12) servant à préparer et à administrer un médicament. Un logement (13) du dispositif injecteur (12) définit une cavité disposée de sorte à recevoir une unité d'injection jetable (1) assembée à partir d'au moins deux parties d'injection (2, 3, 4, 10) distinctes. Un mécanisme de retenue (17, 33) est disposé de sorte à fixer une première partie d'injection (2, 3, 4, 10) de l'unité d'injection jetable (1). Un mécanisme de transfert de force (18, 22, 23, 24) est disposé de sorte à transférer une force linéaire et/ou un couple d'un moteur (15, 20, 21) à une deuxième partie d'injection (2, 3, 4, 10) de l'unité d'injection jetable (1), ce qui entraîne la deuxième partie d'injection (2, 3, 4, 10) à effectuer des mouvements de translation et/ou de rotation par rapport à la première partie d'injection (2, 3, 4, 10), entraînant ainsi l'assemblage automatique ou assisté de la première et de la deuxième partie d'injection (2, 3, 4, 10).
PCT/EP2016/081126 2015-12-22 2016-12-15 Dispositif injecteur destiné à faciliter l'assemblage d'une unité d'injection Ceased WO2017108558A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA201500836 2015-12-22
DKPA201500836 2015-12-22

Publications (1)

Publication Number Publication Date
WO2017108558A1 true WO2017108558A1 (fr) 2017-06-29

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WO (1) WO2017108558A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20190110297A (ko) * 2018-03-20 2019-09-30 가톨릭대학교 산학협력단 이종 주사액 혼합장치
CN112791256A (zh) * 2021-01-25 2021-05-14 魏雪 一种自动切换式无针筒高压造影注射装置

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030105430A1 (en) * 2001-11-30 2003-06-05 Elan Pharma International Limited Wil House Automatic injector
WO2011058560A1 (fr) * 2009-11-12 2011-05-19 Medimop Medical Projects Ltd Module de connexion de seringue pour connecter une seringue à un port de seringue
WO2011077434A1 (fr) * 2009-12-23 2011-06-30 Medimop Medical Projects Ltd Appareil médical et kit à usage unique comprenant un dispositif de régulation du débit destiné à être utilisé avec celui-ci pour la reconstitution et l'administration d'une dose de médicament liquide
WO2013001525A1 (fr) * 2011-06-27 2013-01-03 Medimop Medical Projects Ltd Dispositif de régulation de débit pour reconstitution et administration de dose de médicament liquide, et kit à usage unique et appareil médical pour utilisation avec celui-ci

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030105430A1 (en) * 2001-11-30 2003-06-05 Elan Pharma International Limited Wil House Automatic injector
WO2011058560A1 (fr) * 2009-11-12 2011-05-19 Medimop Medical Projects Ltd Module de connexion de seringue pour connecter une seringue à un port de seringue
WO2011077434A1 (fr) * 2009-12-23 2011-06-30 Medimop Medical Projects Ltd Appareil médical et kit à usage unique comprenant un dispositif de régulation du débit destiné à être utilisé avec celui-ci pour la reconstitution et l'administration d'une dose de médicament liquide
WO2013001525A1 (fr) * 2011-06-27 2013-01-03 Medimop Medical Projects Ltd Dispositif de régulation de débit pour reconstitution et administration de dose de médicament liquide, et kit à usage unique et appareil médical pour utilisation avec celui-ci

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20190110297A (ko) * 2018-03-20 2019-09-30 가톨릭대학교 산학협력단 이종 주사액 혼합장치
KR102296753B1 (ko) 2018-03-20 2021-09-02 가톨릭대학교 산학협력단 이종 주사액 혼합장치
CN112791256A (zh) * 2021-01-25 2021-05-14 魏雪 一种自动切换式无针筒高压造影注射装置
CN112791256B (zh) * 2021-01-25 2021-08-27 西南医科大学附属医院 一种自动切换式无针筒高压造影注射装置

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