SYRINGE UNIT FOR A REUSABLE INJECTION DEVICE

Information

  • Patent Application
  • 20250161588
  • Publication Number
    20250161588
  • Date Filed
    January 21, 2025
    11 months ago
  • Date Published
    May 22, 2025
    7 months ago
Abstract
A disposable syringe unit for an injection device adapted for releasable attachment to a reusable drive unit of the injection device includes a prefilled syringe with a reservoir and an injection needle, a syringe holder for holding the prefilled syringe, a cover member guided by guiding means thereby movable along the longitudinal axis relative to the syringe holder between a covering position in which the injection needle is covered and a retracted position in which the injection needle protrudes from the cover member, and a cap releasably attached to a distal end of the cover member or the syringe holder. Apart from the prefilled syringe, the syringe unit includes in total not more than three separate parts.
Description
TECHNICAL FIELD

The present disclosure relates to drug delivery devices or medicament delivery devices for injecting, delivering, administering, infusing or dispensing substances and/or liquids such as insulin, hormone preparations or vaccines. More particularly, provided is an injection device comprising a reusable drive unit and a disposable syringe unit configured for releasable attachment to the drive unit.


BACKGROUND

A variety of diseases exist that require regular treatment by subcutaneous administration of a medicament, and a number of drug delivery devices have been developed to support a patient in accurately and controllably delivering an amount of drug in a self-administration process. Delivery devices include injection devices that are removed from the injection site after each medication event or drug delivery process, as well as infusion devices with a cannula or needle that remains in the skin of the patient for a prolonged period of time.


By way of example, diabetes may be treated by self-administration of insulin or its derivatives with the help of multi-variable-dose insulin injection pens. An injection pen device generally has an elongate device body defining a longitudinal main device axis. An automatic injection device has a motor or a drive spring for biasing a plunger rod and shifting a piston in a container barrel, where the drive spring may have to be charged or strained manually prior to injection of a dose. A manually powered delivery drive requires a user to manually provide the energy to move the piston, for instance by applying a distal force component to the injection device.


The medicament dose to be injected may typically be manually selected by turning a dosage knob and observing the actual dialed dose from a dose window or display of the insulin pen. A dose is dispensed by inserting the needle into a suited portion of human skin and by moving the piston manually or by pressing a release button of an automatic injection device. Automatic injection devices may include an electronic dose dial mechanism to automatically set a dose.


Also known is the use of autoinjectors with syringes. Autoinjectors usually include a body for housing a syringe as well as a drive mechanism in order to move the plunger of the syringe upon actuation of the autoinjector. The drive mechanism typically includes a source of drive, such as a motor or strong spring for moving a transfer element, for example a rod, which acts on the plunger of the syringe.


For safety and hygiene reasons it is desirable that the needle does not protrude from a housing of the auto injector with the exception of the time when the needle is used for injection of a medicament. Thus, either the autoinjector moves the needle out of the housing for the injection and back into the housing after injection or the housing provides a needle guard which may be moved to unsheathe the needle for injection and which may be moved back to a needle covering position after the injection.


The majority of autoinjectors are configured as single use devices which incorporate both the syringe and the drive mechanism in the same housing. Such devices are usually disposable for hygiene reasons.


Disposable auto injectors comprising an electric actuator or an electronic control require a source of energy which is usually in the form of a battery. However, in this case, the autoinjectors should not be disposed in the regular waste, but have to be subjected to special disposal or to recycling, which is an additional burden to the patient. Further, disposing a battery, motor and/or electronics after a single use is a waste of resources and increases the costs of the auto injector.


In order to account for a need to handle and dispose the autoinjector parts differently semi-reusable autoinjectors have been developed. Such autoinjectors typically include a reusable drive unit as well as a disposable syringe unit which may be releasably coupled to the drive unit. The drive unit usually includes the drive mechanism and electronics whereas the syringe unit includes the syringe with the needle and a needle cover sleeve. The user can thus discard the syringe unit when it is empty or after use and can load the drive unit with a new syringe unit for the upcoming injection.


WO 2010/046569 discloses a reusable autoinjector, where a syringe unit is to be coupled to a drive unit by a bayonet connection. Once a cam of the drive unit is inserted in a slot in the syringe unit housing a cover sleeve is unlocked and can be moved to unsheathe the needle for an injection. The syringe unit includes a unit-housing, a shield, a syringe holder and two springs biasing the shield to a covering position.


WO 2021/069106 discloses an autoinjector comprising a disposable syringe unit and a reusable drive unit. Apart from a syringe barrel with a rigid needle shield the syringe unit includes a syringe holder, a syringe holder support tube, syringe holder arms, a cassette housing, a sensor sleeve, an outer shield tube and a cassette cap mounted on a distal end of the syringe unit.


WO 2012/145685 discloses further a reusable autoinjector with a disposable or single-use cassette and a reusable drive unit. The cassette includes an outer housing, an inner sleeve, a shield remover, a movable cover and a lock cap locking the syringe to the inner sleeve.


SUMMARY

It is an objective of the disclosure to provide a simplified manufacturing, handling and to reduce waste for semi-reusable injection devices.


The disclosure relates to a disposable or single-use syringe unit (or reservoir unit) for an injection device configured for releasable attachment to a reusable drive unit of the injection device. According to the disclosure the syringe unit consists of:

    • a prefilled syringe comprising a reservoir and an injection needle (18) permanently connected to the reservoir and optionally covered by a needle shield in a shipping state, e.g., prior to use;
    • a syringe holder (30) for holding the prefilled syringe (15), the syringe holder (30) comprising guiding means (31) and defining a longitudinal axis;
    • a cover member (20) guided by the guiding means (31) thereby movable along the longitudinal axis relative to the syringe holder (30) between a covering position in which the injection needle (18) is covered and a retracted position in which the injection needle (18) exposes and protrudes from the cover member (20);
    • a cap (10) releasably attached to a distal end of the cover member (20) or the syringe holder (30);


Apart from the prefilled syringe (including syringe elements) the syringe unit (30) includes in total not more than three separate parts.


Syringe elements may be an injection needle in separately connected to a glass syringe barrel, a piston movably arranged inside the syringe barrel and a needle shield directly mounted onto the metallic injection needle in an unused or shipping state, e.g., prior to use.


That means according to the disclosure the syringe unit includes or consists of in total at maximum three separate parts (prefilled syringe with syringe elements not counted) made of plastic or metal or both plastic and metal, the three parts may be separately produced.


As apart from the prefilled syringe the syringe unit includes not more than three parts the manufacturing, the assembly, the handling and storage of the syringe unit is simplified compared to syringe units with more parts. A reduced amount of parts can thus help to reduce the overall production costs and reduce the complexity of the syringe unit.


Besides that, the amount of discarded parts and thus the waste of a reusable injection device concept can be reduced which is advantageous from an environmental perspective.


The disposable syringe unit is part of the semi-disposable or semi-reusable injection device. The syringe unit is hence not operational without a reusable drive unit of the injection device. To prepare the injection device for an injection the user has to attach or to connect the syringe unit to a drive unit. The drive unit may include drive means adapted to dispense the liquid drug from the syringe hold inside the syringe unit once the syringe unit is attached to the drive unit.


The injection device may be a manual or an automatic injection device. Automatic devices or autoinjectors typically include automatic drive means such as an elastic element (for example a pre-tensioned spring) or an electric motor to drive a dispensing member to dispense the liquid drug form the syringe. Manual injection devices include a manual drive such as a dispensing button that has to be pressed by the user to move the dispensing member in dispensing direction.


The cover member or needle cover is movable along the longitudinal axis and guided by the syringe holder. The cover member may be implemented as shield or sleeve or sleeve-shaped element adapted to cover or envelop a needle of a prefilled syringe mounted inside the syringe holder. The movement of the needle cover allows to switch between a safety state in which the needle is covered and the needle does not protrude from a device housing and an injection state in which the needle is uncovered and exposes or protrudes from the housing.


In an embodiment the cover member is the outermost part of the disposable syringe unit. That means the syringe unit does not include any outer housing or shell but only the movable cover member. This provides for a simple design.


The syringe holder, the cover member and the cap may be separate plastic parts. The term “separate” means that before assembly the parts can be handled independently from each other and may be produced separately and independently from other parts. That does not exclude that the parts may be connected upon assembly of the syringe unit. The parts may be connected to each other, for example, by a snap-fit or a thread.


As stated above the prefilled syringe with its possibly present needle shield (often named as rigid needle shield, RNS) is not counted as the syringe is usually inserted and fixed to the pre-assembled syringe unit at a later stage. Likewise, a possibly present label, sticker or tag attached to an outside or exterior surface of one of the syringe unit parts does not count as a separate part.


The syringe holder, the cover sleeve and the cap may be individually injection-molded thermoplastic plastics parts. That means the syringe holder, cover sleeve and the cap are not made from an elastomeric material. In comparison a piston or bung arranged inside the glass barrel of the syringe may be made of an elastomeric material like rubber. Such a piston or bung is a syringe element.


The injection-molded parts allow for a cost-effective production of the syringe unit parts in particular in case of a high volume production.


The syringe may be non-movably arranged within the syringe holder after assembly. That means during an injection the syringe does not move relative to the syringe holder meaning that the user has to insert or penetrate the injection needle into the injection site by a manual insertion force.


The syringe includes usually a cylindrical barrel made of glass and an injection needle made of steel inseparably connected to the barrel. Furthermore, the syringe may include the rigid needle shield which is directly mounted onto the injection needle upon production of the syringe and which prevents access to the needle before removal of the rigid needle shield.


The syringe with the barrel, the injection needle and the rigid needle shield are thus produced as a unit which can be mounted inside the syringe holder.


In an embodiment apart from the syringe with its syringe elements (piston, needle, rigid needle shield directly mounted on the needle in a shipping state, e.g., prior to use) the syringe unit includes exclusively plastic parts and the syringe unit may include exclusively injection molded thermoplastic plastic parts (apart from the syringe and its syringe elements). That means the syringe unit is devoid of or free of any metal parts such as springs, clamps or the like. This facilitates the production and contributes to a cost-efficient design.


Optionally, the syringe holder includes at least one radially protruding flexible arm with a free end portion and where the cover member includes at least one stop surface and where the free end portion is adapted to engage the stop surface to hold the cover member in the covering position and thus preventing a movement of the cover member out of the covering position towards a retracted position. That means the arm allows for a reliable holding of the cover member in the covering position in which it covers the injection needle. Furthermore, by a movement of the arm or of the free end portion the cover member may be unlocked and thus allowing a quick unlock of the cover member such that it can be retracted to uncover the injection needle.


The stop surface may be arranged, for example, on a ledge or protrusion and may be arranged inside a cover member shell or cover member shell.


The at least one arm is in an embodiment integrally formed in the syringe holder. That means the arm is monolithic with the syringe holder. That allows for an efficient production and handling as the syringe holder and the arm can be produced by one single injection-molded plastic part.


Advantageously, the end portion of the at least one arm engages the at least one stop surface in a non-deflected position of the arm and the end portion is disengaged from the ledge in a deflected state of the arm thereby allowing the cover member to be moved out of the covering position towards a retracted position in which the injection needle is uncovered or exposes. The deflectable arm allows for a quick and reliable lock or unlocking of the cover member.


In a an embodiment the cover member includes a machine-readable code attached on a surface of the cover member. The code includes syringe unit-specific identification information. An external code reader may read the information from the code and based on read identification information the syringe unit and the drug inside the syringe may be identified. The identification information may include data about the syringe, the drug, a volume, and an expiration date or injection instruction for the drug contained inside the syringe.


The external code reader may be an external device or it may be in the drive unit and adapted to read the code once the syringe unit is attached to the drive unit.


The machine-readable code may be implemented in form of optical code or a code readable based on electromagnetic fields. Examples for an optical code are an Object Identifier code (OID), QR codes, bar codes, color codes and optical patterns. Examples for codes based on electromagnetic fields are a radio-frequency identification (RFID) tag or near-field communication (NFC) tags.


The code may be attached on an outside or exterior surface of the cover member, for example, by means of a label or sticker including the code. Alternatively, the code may be on an interior surface or integrally formed in a wall of the cover member as electromagnetic tag or chip.


The cover member is a sleeve in a an embodiment. The syringe holder is then concentrically arranged inside the sleeve. Therefore, the cover sleeve is movable along the longitudinal axis outside and relative to the syringe holder if the cover member is not blocked or hold in the covering position. The sleeve form allows for a compact design.


The cover sleeve may include a first radial opening or an opening. The arm of the syringe holder is thus accessible from the outside or exterior through the first opening. Therefore, the arm can be actuated through the opening to move or release the arm which in turn allows to unlock the cover member from the covering position or to lock the cover member in the covering position, respectively.


Furthermore, the syringe holder may include a radially extending protrusion or rim for holding the syringe unit by the reusable unit when the syringe unit is attached or connected to the drive unit. The sleeve may include a second radial opening where the protrusion or rim is accessible from the outside or exterior through the second opening.


Thus, the syringe unit may be held by a clamp or holding arms extending through the second opening in the cover member sleeve.


The guiding means of the syringe holder includes a longitudinal groove or a longitudinal spline on an outside or exterior surface and the cover sleeve includes on an interior surface the other of the longitudinal groove or the longitudinal spline. The cover sleeve is thus reliably guided by the spline and groove and can be moved along the longitudinal axis.


The spline may be implemented as protrusion or ledge or as swallowtail. The guiding means may be implemented alternatively as rail and clamp adapted to engage the rail.


The disclosure relates further to an injection device comprising the disposable syringe unit as described above and the reusable drive unit. The latter may include a plunger rod and a drive for moving the plunger rod in a dispensing direction to dispense the drug from the syringe. The syringe unit is releasably attachable to the drive unit.


As mentioned above the injection device may be a manual injection device requiring a user force to drive the plunger rod to dispense the drug or alternatively the injection device may be an automatic injection device including an automatic drive, for example, in form of a biased spring member or an electric motor.


The drive unit may further include flexible holding arms engaging the radial extending protrusion or rim of the syringe holder if the syringe unit is attached to the drive unit. The flexible holding arms allow for a releasably attachment of the syringe unit to the drive unit.


In an embodiment the cover member may be locked to the syringe holder in the covering position, and the cover member may be unlocked by relative movement between the syringe unit and the drive unit. The syringe unit may be moved manually by a user or automatically by the automatic drive of the drive unit.


The injection device may be a semi-reusable (or semi-disposable) autoinjector. The automatic drive may include an electric motor adapted to drive the plunger rod to dispense the drug from the syringe.





BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter of the disclosure will be explained in more detail in the following text with reference to exemplary embodiments which are illustrated in the attached drawings, in which:



FIG. 1 depicts an isometric view of a semi-reusable autoinjector according to the disclosure;



FIG. 2 depicts an exploded view of the syringe unit of the autoinjector from FIG. 1;



FIG. 3 depicts a sectional view of the drive unit of the autoinjector;



FIG. 4 depicts the drive unit with an inserted syringe unit; and



FIG. 5 depicts a sectional view of the autoinjector where the syringe unit is locked to the drive unit.





The reference symbols used in the drawings, and their primary meanings, are listed in summary form in the list of designations. In principle, identical parts are provided with the same reference symbols in the figures.


DETAILED DESCRIPTION
Definitions

In the present context, the terms “substance”, “drug”, “medicament” and “medication” are to be understood to include any flowable medical formulation suitable for controlled administration through a means such as, for example, a cannula or a hollow needle, and includes a liquid, a solution, a gel or a fine suspension containing one or more medical active ingredients. A medicament can be a composition comprising a single active ingredient or a pre-mixed or co-formulated composition with more than one active ingredient present in a single container. Medication includes drugs such as peptides (e.g., insulin, insulin-containing drugs, GLP-1 containing drugs or derived or analogous preparations), proteins and hormones, active ingredients derived from, or harvested by, biological sources, active ingredients based on hormones or genes, nutritional formulations, enzymes and other substances in both solid (suspended) or liquid form but also polysaccharides, vaccines, DNA, RNA, oligonucleotides, antibodies or parts of antibodies but also appropriate basic, auxiliary and carrier substances


The term “injection system” or “injector” refers to a device that is removed from the injection site after each medication event or drug delivery process, whereas the term “infusion system” refers to a device with a cannula or needle that remains in the skin of the patient for a prolonged period of time, for example, several hours.


The term “distal” is meant to refer to the direction or the end of the drug delivery device carrying an injection needle or an injection cannula, whereas the term “proximal” is meant to refer to the opposite direction or end pointing away from the needle or cannula. In the present description the term “distal” refers to the side where the injection needle is located. This is on the left hand side in the FIGS. 1 to 5. The term “proximal” refers to the opposite side or rear end of the device and is on the right hand side in the figures.



FIG. 1 shows a perspective view of a drug delivery device of a first embodiment of the disclosure in form of a semi-reusable autoinjector 1. The autoinjector 1 includes a disposable syringe unit 2 and a reusable drive unit 3. As shown in FIG. 1 the drive unit 3 has an elongated housing defining a longitudinal axis and includes a button 4 at its proximal end.


In the following the structural features of the syringe unit and the drive unit will be descripted in detail. Subsequently, the function of the semi-reusable autoinjector 1 will be explained.



FIG. 2 depicts an exploded view of the syringe unit 2. As shown in FIG. 2 the syringe unit 2 includes a syringe holder 30, a cover sleeve 20 coaxially arranged around the syringe holder 30 and movable relative to the syringe holder along the longitudinal axis, a label 25 wrapped around the cover sleeve 20, a cap 10 and a prefilled syringe 15 comprising a liquid drug and a rigid needle shield 17 on the injection needle. The syringe holder 30, the cover sleeve 20 and the cap 10 are individually injection-molded plastic parts.


The prefilled syringe 15 with a barrel made of glass is rotationally and axially fixed inside the sleeve-shaped syringe holder 30. For that purpose, the syringe holder 30 includes clamping elements pressing on an outer surface of the syringe barrel and a distal shoulder of the syringe abuts a bearing surface 34 (see FIG. 4) inside the syringe holder 30. As shown in FIG. 2 the syringe holder 30 further features longitudinal guiding rails 31 on its outside for the cover sleeve 20 such that the cover sleeve 20 can be shifted exclusively in the longitudinal direction relative to the syringe holder 30. Furthermore, the syringe holder 30 includes two radially deflectable lock elements in form of locking arms 32 arranged on opposite sides of the syringe holder 30. In an initial state the locking arms 32 are in a non-deflected state and in a locking position and prevent a movement of the cover sleeve 20 relative to the syringe holder 30 in a proximal direction. Hence, the cover sleeve 20 shields or covers the injection needle of the syringe 15 in a covering position. For that purpose, a free end of the locking arms 32 abut stop surfaces (24) inside the cover sleeve 20. As will be descripted below once the locking arms 32 are deflected radially inwards the cover sleeve 20 can be pushed proximally. The syringe holder 30 further includes two oppositely arranged and radially protruding ledges 33 at a proximal end of the syringe holder 30 for engagement with clamping arms 61 (FIG. 4) inside the drive unit 3.


The cover sleeve 20 has a non-circular cross section in a plane perpendicular to the longitudinal axis. That means two sides of the cover sleeve are flattened. The cover sleeve includes a first lateral opening 21 for access to the locking arms 32 and a proximal second opening 22 for access to the ledges 33 from outside. The label 25 wrapped around the cover sleeve 20 includes a machine-readable tag in form of a RFID or QR code 26 identifying the syringe unit 2.


At a distal end of the cover sleeve 20 the cap 10 is releasably attached by a snap-fit connection. The cap 10 includes on two sides two deflectable elements or tongues 11 and on each side a protrusion engaging in a corresponding indentation 23 in the cover sleeve 20 for the snap-fit connection. Alternatively, the cap 10 may have an ellipse shape in a plane perpendicular to the longitudinal axis where inside the ellipse form the protrusions engage the indentation in the cover sleeve. The ellipse can be deformed to a circular shape to release the protrusions from the indentation 23. The release of the snap-fit will be descripted below with respect to the de-capping of the syringe unit 2. The cap 10 includes in its inside a sleeve-shaped holder 12 connectable to the rigid needle shield (RNS) 17 of the syringe 15 such that the RNS 17 is removed with the cap 10 if the cap is released from the needle cover.


The syringe 15 inside the syringe holder 30 has a barrel made of glass and inside the barrel a movable piston 16 (FIG. 4). An injection needle 18 (FIG. 4) is non-releasably connected to a distal end of the syringe barrel. In an unused state the injection needle 18 is covered by the RNS 17. The latter in turn is axially and radially fixedly connected to the cap 10 by the holder 12 once the syringe 15 is mounted to the syringe holder 30.



FIG. 3 depicts a sectional view of a first embodiment of the drive unit 3. The cut of the sectional view runs along the longitudinal axis of the device. The drive unit 3 includes a housing 80 including an outer housing cover and inside the cover a sleeve mechanism 83 comprising a radial wall 84 that separates the drive 3 unit in a distal portion and a proximal portion. The sleeve mechanism 83 is immovably connected to the housing 80. Inside the housing 80 and distally the separating wall 84 is a distal housing insert 81 whereas proximal the wall 84 a proximal housing insert 85 is located. The distal and proximal housing inserts 81, 85 are immovably connected to the housing 80. Furthermore, the drive unit 3 includes an opening on its distal side adapted to accommodate a proximal portion of the syringe unit 2.


Inside the distal housing portion and guided by the distal housing insert 81 a gripper sleeve 60 is arranged and movable relative to the housing 80 along the longitudinal axis. Coaxially to the gripper sleeve 60 a trigger sleeve 50 is arranged. Again inside the trigger sleeve 50 a cover sleeve connector 45 is located and biased in distal direction by a cover sleeve spring 46. The spring abuts on its distal end the cover sleeve connector 45 and on its proximal end the radial wall 84 of the sleeve mechanism 83. A sleeve-shaped syringe connector 47 is coaxially arranged inside the cover sleeve connector 45 and biased distally by a syringe connector spring 48 coaxially inside the cover sleeve spring 46 and proximally supported by the wall 84. The spring 46 ensures that the syringe connector 45 pushes the syringe 15 of an inserted syringe unit 2 in distal direction.


The proximal housing portion accommodates the proximal housing insert 85 which supports and guides a sleeve-shaped trigger sleeve connector 51 movable along the longitudinal axis, a drive assembly with an electric motor 91, a pinion 92 and a gear 93 connecting the motor 91 with a threaded rod 41, a battery 94, the treaded rod 41 and a plunger rod 40 in threadedly connected to the threaded rod 41. The proximal housing portion further accommodates an electronic module with a controller configured to control the electronic motor 91 and providing information to the user via a display or LEDs or a communication module. The trigger sleeve connector 51 is fixedly and immovably connected to the trigger sleeve 50 and distally pressed onto a proximal end of the plunger rod 40 by a trigger sleeve spring 53. The plunger rod 40 non-rotatably guided by the sleeve mechanism 83 and includes on its distal end a flange 49 adapted to engage the piston 16 (see FIG. 4) during dispensing.


Inside the proximal housing portion is further an axially arranged detection pin axially movable by the cover sleeve connector 45. The detection pin is connected to and interacts with a TMR position sensor. The presence of a syringe unit 2 inside the drive unit housing 80 is thus detectable via detection pin and the position sensor which provides a corresponding signal to the controller of the electronic module.


The gripper sleeve 60 includes two axially extending and deflectable clamping arms 61 having a clamp 62 at their free distal end adapted to accommodate the syringe holder ledges 33. The clamping arms 61 can be deflected radially outwards allowing the clamps 62 to snap onto the ledges 33 of the syringe holder 30 when the syringe unit is inserted into the opening in the drive unit 3. On its outside the gripper sleeve 60 includes splines running in corresponding longitudinal grooves in the distal housing insert 81 guiding the gripper sleeve 60 during an axial movement relative to the housing 80. Furthermore, each clamping arm 61 provides a support for an axially aligned gripper sleeve spring 64 which biases the clamping arms 61 in a holding position.


The trigger sleeve 50 is axially guided by the gripper sleeve 60 as well as by the distal housing insert 81 and shiftable relative thereto. For this purpose, the trigger sleeve 50 includes longitudinal guiding rails engaging longitudinal grooves in both the distal housing insert 81 and the gripper sleeve 60. As it can be seen in FIG. 3 the trigger sleeve 50 incudes oppositely arranged trigger arms 54 which include on their proximal free end 56 a guiding surface or sloped contact surface 55. The trigger arms 54 are deflectable radially inwards upon contact of the contact surface 55 with a counter guiding surface or counter sloped contact surfaces 82 of the distal housing insert 81. As mentioned above the trigger sleeve 50 is further immovably connected to the trigger sleeve connector 51 in the proximal housing portion. As the trigger sleeve connector 51 is biased by the trigger sleeve spring 53 the trigger sleeve 50 is biased too in distal direction. The trigger sleeve connector 51 in turn is connected to the plunger rod via ledges 52 which engage a proximal shoulder of the plunger rod 40 such that an axial movement of the plunger rod 40 in proximal direction also moves the trigger sleeve 50 proximally.


In the state shown in FIG. 3 the drive unit 3 is ready to be loaded with a syringe unit 2. The controller displays the current state to the user via display by showing a message like “Syringe Unit Insertion” or via green or red LEDs.


In order to prepare the autoinjector 1 for an injection the user attaches a syringe unit 2 to the drive unit 3. The electronics in the drive unit 3 are switched from an inactive state or sleep mode to an active mode. Alternatively, the user can press the button 4 to activate the electronics.



FIG. 4 depicts a sectional view of the drive unit 3 with an inserted syringe unit 2. The syringe unit 2 has been inserted with its proximal end portion into the distal opening of the drive unit housing 80. In the state shown in FIG. 4 the proximal ledges 33 of the syringe holder 30 are snapped into recesses of the clamps 62 of the gripper sleeve clamping arms 61. The syringe unit 2 is thus held in the drive unit 3 by the clamping arms 61. However, in the shown state in FIG. 4 the syringe unit 2 can still be pulled out of the drive unit housing by overcoming a holding force. Hence, if the user pulls the syringe unit 2 in a distal direction the syringe holder 30 with the syringe 15 are firstly moved in distal direction relative to the cover sleeve 20 until stop and subsequently the cover sleeve 20 is moved distally too. This brings inclined release surfaces 27 of the cover sleeve 20 into contact with inclined counter surfaces 65 of the clamping arms 61. If the cover sleeve 20 is further pulled in distal direction the clamping arms 61 are deflected radially outwards via release surfaces 27 and counter surfaces 65. The ledges 33 of the syringe holder 30 are therefore released from the clamping arms 61 and the syringe unit 2 can be removed from the drive unit 3. out of the drive unit 3 the clamping arms 61 may deflect radially outwards and release the ledges 33.


That means in the state shown in FIG. 4 the syringe unit 2 is held inside the drive unit 3 but not yet locked inside the drive unit 3.



FIG. 5 depicts the autoinjector 1 in a locked state without cap. When the syringe unit 2 is inserted as described above the syringe unit 2 moves the detection pin and thus the position sensor detects the movement and automatically sends a signal to the controller in the electronic module which detects the presence of the syringe unit 2 inside the drive unit housing. A code reader in form of an NFC reader or QR code reader inside the drive unit 3 reads the RFID or QR code 26 of the syringe unit 2. Subsequently, the controller of the drive unit sends the read medication information from the read code 26 to an external device to verify the drug or medication with predefined information. Alternatively, the controller compares the read medication information from the code 26 with predefined information stored in a memory inside the drive unit 2.


In case of successful medication verification the controller receives an enable signal (either from the external device or from the internal comparison). The controller then controls the electric motor 91 to rotate the threaded rod 41 to move the trigger sleeve 50 a short distance of several millimeters in proximal direction. Such a trigger sleeve 50 movement is achieved by a kinematic chain as described as follows.


The motor 91 rotates the pinion 92 and the gear 93 transfers the rotation to the threaded rod 41 which in turn moves the non-rotating plunger rod 40 in proximal direction. As the trigger sleeve connector 51 is connected via its ledges 52 to a proximal shoulder of the plunger rod 40 the latter causes the trigger sleeve connector 51 to move and thus the trigger sleeve 50 is shifted in proximal direction too.


The proximal movement of the trigger sleeve 50 brings the sloped contact surfaces 55 of the trigger arms 54 into contact with the counter sloped contact surfaces 82 of the distal housing insert 81. As the two sloped surfaces 55, 82 slide along each other the trigger arms 54 are forced to deflect radially inwards when the trigger sleeve 50 is further moved in proximal direction. The free ends 56 of the deflected trigger arms 54 in turn come into contact with the locking arms 32 of the syringe holder 30. Subsequently, the trigger arms 54 deflect the locking arms 32 radially inwards and thus move the locking arms 32 out of a locking position. As a consequence, the locking arms 32 no longer engage the stop surface (24) of the cover sleeve 20 and thus allow for the cover sleeve 20 to move out of a covering position and move inside the housing 80 in proximal direction relative to the syringe holder 30 and relative to the drive unit housing 80.


At the same time, the radially inwards deflected trigger sleeve arms 54 abut a distal stop surface of the syringe holder 30 and thereby lock the syringe holder 30 relative to the trigger sleeve 50 such that a movement of the trigger sleeve 50 is transferred to the syringe unit 2. Thus, in this state (FIG. 5) the syringe unit 2 can no longer pulled out of the drive unit 3.


The controller displays the locked state to the user via display. As in this state the cap is still mounted onto the distal end of the cover sleeve 20 the next step is the de-capping which may be started by pressing the button 4. The controller then drives the motor 91 to move additionally the trigger sleeve 50 a short distance of 1 to 5 mm in proximal direction and immediately the same distance back in distal direction. As the trigger arms 54 fix the syringe unit 2 relative trigger sleeve 50 the syringe unit 2 (and the gripper sleeve 60) are moved back and forth too. The proximal movement of the syringe unit 2 with the cap 10 relative to the drive unit housing 80 compresses the trigger sleeve spring 53. In FIG. 5 it can be seen the trigger sleeve connector 51 was moved a distance in proximal direction (see distance between ledges 52 and proximal end of the sleeve mechanism 83). The proximal movement of the syringe unit 2 relative to the housing 80 further causes the deflectable cap tongues 11 (FIG. 2) of the cap 10 to abut against a triangle-shaped protrusion 86 (FIG. 3) on a distal end of the drive unit housing 80. As a consequence, if the syringe unit 2 is further moved into the drive unit housing 80 the protrusion 86 deflects the cap tongues 11 and thereby releases the snap-fit connection of the cap 10 with the cover sleeve 20. Consequently, the cap 10 is wiped off. This leads to the state shown in FIG. 5. The controller moves then motor 91 in counter direction to move the plunger rod 40 back the short distance of 1 to 5 mm but without unlocking the syringe unit 2. The syringe unit 2, the trigger sleeve 50 and the gripper sleeve 60 are moved back due to the spring force of the trigger sleeve spring 53.


The autoinjector 1 is now de-capped and ready for an injection. The controller displays a corresponding notification on the display.


As a next step the user places the distal end of the cover sleeve 20 onto an injection site and pushes the autoinjector 1 towards the injection site. This causes the cover sleeve 20 to move proximally from the distal covering position into the drive unit housing 80 (push on skin) and compresses the cover sleeve spring 46 which biases the cover sleeve 20 in distal direction via cover sleeve connector 45. Upon push on skin the cover sleeve connector 45 is moved proximally and thus the detection pin is further moved proximally. This further movement is detected by a further TMR position sensor which triggers the controller in the electronic module to start the injection. That means the controller drives the electric motor 91 in dispensing direction and thus rotates the threaded rod 41 and thereby moves the plunger rod 40 in distal direction. As the trigger sleeve spring 53 biases the trigger sleeve connector 45 on the proximal shoulder of the plunger rod 40 (alternatively the trigger sleeve connector 45 is immovably connected to the plunger rod 40) the trigger sleeve 50 is also moved in distal dispensing direction. The distal flange 49 of the plunger rod 40 moves the piston 16 inside the syringe 15 in distal direction and thus dispenses liquid drug through the injection needle out of the syringe 15.


The distal movement of the plunger rod 40 moves the trigger sleeve via trigger sleeve connector 51 in distal direction to its initial position. That means the trigger arms 54 can move radially outwards back into their non-deflected position. However, as the cover sleeve 20 is in a retracted proximal position the locking arms 32 are prevented from being moved back into the locking position.


The controller displays a holding time indicating a time period during that the user has to hold the autoinjector 1 onto the injection side after the injection to ensure that the drug is completely administered and absorbed. The controller may display a down counter informing the user about the remaining holding time. Once the holding time is elapsed a notification is shown to the user that the autoinjector can be removed from the injection site. Alternatively, the end of the holding time may be indicated only by a LED.


When the user removes the autoinjector 1 from the injection site the compressed cover sleeve spring 46 can release and thus it can move the cover sleeve 20 back distally into the needle covering position.


During dispensing the trigger sleeve 50 was moved in its initial distal and unlocking position in which the trigger arms 54 are not deflected anymore and thus do not contact the locking arms 32 of the syringe holder 30. That means the locking arms 32 are no longer completely pressed radially inwards and upon movement of the cover sleeve 20 into its covering position the locking arms 32 are able to switch back into their locking position in which the free end of the arms 32 abuts the contact surface inside the cover sleeve 20 thereby locking the cover sleeve 20 in its covering position as in the state shown in FIG. 4.


Furthermore, as the trigger arms 54 are not deflected anymore and thus do not contact the distal stop surface of the syringe holder 30 the entire syringe unit 2 can be pulled out of the drive unit housing 80 by the user. The user can now discard the syringe unit 2 and the drive unit 3 is ready to be loaded with a new syringe unit.


In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. For example “an arm” does not exclude the fact that there may be two arms that functionally or structurally fulfill the purpose of “an arm”. The mere fact that certain elements or steps are recited in distinct claims shall not preclude the existence of further meaningful combinations of these elements or steps.


While the disclosure has been described in detail in the drawings and foregoing description, such description is to be considered illustrative or exemplary and not restrictive. Variations to the disclosed embodiments can be understood and effected by those skilled in the art and practising the claimed disclosure, from a study of the drawings, the disclosure, and the appended claims.












LIST OF DESIGNATIONS


















1
autoinjector



2
syringe unit



3
drive unit



4
button



10
cap



11
deflectable tongues



12
clamps



15
prefilled syringe



16
piston



17
rigid needle shield



18
injection needle



20
cover sleeve



21
first opening



22
second opening



23
indentation



24
stop surface



25
label



26
RFID tag



27
release surface



30
syringe holder



31
longitudinal rail



32
locking arms



33
ledge



34
bearing surface



40
plunger rod



41
threaded rod



45
cover sleeve




connector



46
cover sleeve spring



47
syringe connector



48
syringe connector




spring



49
flange



50
trigger sleeve



51
trigger sleeve connector



52
ledge



53
trigger sleeve spring



54
trigger arm



55
arm sloped contact




surface



56
free end



60
gripper sleeve



61
clamping arms



62
clamp



64
gripper sleeve spring



65
counter release surface



80
housing



81
distal housing insert



82
contact surface



83
sleeve mechanism



84
wall



85
proximal housing insert



86
protrusion



91
electric motor



92
pinion



93
gear



94
battery









Claims
  • 1. A disposable syringe unit for an injection device adapted for releasable attachment to a reusable drive unit of the injection device, the syringe unit comprising: a prefilled syringe comprising a reservoir and an injection needle permanently connected to the reservoir and covered by a needle shield prior to use;a syringe holder configured for holding the prefilled syringe, the syringe holder comprising guiding means and defining a longitudinal axis;a cover member guided by the guiding means and movable along the longitudinal axis relative to the syringe holder between a covering position in which the injection needle is covered and a retracted position in which the injection needle protrudes from the cover member; anda cap releasably attached to a distal end of the cover member or the syringe holder,wherein apart from the prefilled syringe, the syringe unit comprises in total not more than three separate parts.
  • 2. The disposable syringe unit according to claim 1, wherein the syringe holder, the cover sleeve and the cap are injection-molded thermoplastic plastics parts.
  • 3. The disposable syringe unit according to claim 1, wherein the syringe is non-movably arranged within the syringe holder after assembly.
  • 4. The disposable syringe unit according to claim 1, wherein the syringe comprises a cylindrical barrel made of glass and an injection needle made of steel inseparably connected to the barrel.
  • 5. The disposable syringe unit according to claim 1, wherein the syringe unit, other than the prefilled syringe, is devoid of metallic parts.
  • 6. The disposable syringe unit according to claim 1, wherein the syringe holder comprises a radially protruding flexible arm configured with a free end portion, wherein the cover member comprises a stop surface, and wherein the free end portion is adapted to engage the stop surface to hold the cover member in the covering position.
  • 7. The disposable syringe unit according to claim 6, wherein the flexible arm is integrally formed by the syringe holder.
  • 8. The disposable syringe unit according to claim 6, wherein the end portion engages the stop surface in a non-deflected position of the arm and the end portion is disengaged from the stop surface in a deflected state of the arm thereby allowing the cover member to be moved out of the covering position.
  • 9. The disposable syringe unit according to claim 1, wherein the cover member comprises a machine-readable code attached to a surface of the cover member, the code comprising syringe unit-specific identification information.
  • 10. The disposable syringe unit according to claim 1, wherein the cover member is a sleeve, and wherein the syringe holder is concentrically arranged inside the sleeve.
  • 11. The disposable syringe unit according to claim 10, wherein the sleeve comprises a first radial opening, and wherein a radially protruding flexible arm configured with a free end portion of the syringe holder is accessible from an exterior through the first opening.
  • 12. The disposable syringe unit according to claim 11, wherein the syringe holder comprises a radially extending protrusion for holding the syringe unit by the reusable unit, and wherein the sleeve comprises a second radial opening and the protrusion is accessible from the exterior through the second opening.
  • 13. The disposable syringe unit according to claim 10, wherein the guiding means of the syringe holder comprises a longitudinal groove or a longitudinal spline on an exterior surface, and wherein the sleeve comprises the other of the longitudinal groove or the longitudinal spline on an interior surface.
  • 14. A disposable syringe unit for an injection device adapted for releasable attachment to a reusable drive unit of the injection device, the syringe unit comprising: a prefilled syringe comprising a reservoir and an injection needle permanently connected to the reservoir;a syringe holder configured for holding the prefilled syringe and comprising a radially protruding flexible arm with a free end portion;a cover member movable relative to the syringe holder along a longitudinal axis of the disposable syringe unit between a covering position in which the injection needle is covered and a retracted position in which the injection needle protrudes from the cover member; anda cap releasably attached to a distal end of the cover member or the syringe holder,wherein the cover member comprises a stop surface and the free end portion is adapted to engage the stop surface to hold the cover member in the covering position, andwherein apart from the prefilled syringe, the syringe unit comprises in total not more than three separate parts.
  • 15. An injection device comprising a disposable syringe unit and a reusable drive unit comprising a plunger rod and a drive for moving the plunger rod in a dispensing direction to dispense a drug from the syringe, wherein the syringe unit is releasably attachable to the drive unit, and wherein the syringe unit comprises: a prefilled syringe comprising a reservoir and an injection needle permanently connected to the reservoir and covered by a needle shield prior to use;a syringe holder configured for holding the prefilled syringe, wherein the syringe is non-movably arranged within the syringe holder after assembly;a cover member movable relative to the syringe holder along a longitudinal axis of the syringe unit between a covering position in which the injection needle is covered and a retracted position in which the injection needle protrudes from the cover member; anda cap releasably attached to a distal end of the cover member or the syringe holder,wherein apart from the prefilled syringe, the syringe unit comprises in total not more than three separate parts.
  • 16. The injection device according to claim 15, wherein the injection device is a semi-reusable autoinjector, and wherein the drive unit comprises an electric motor.
Priority Claims (1)
Number Date Country Kind
22186392.1 Jul 2022 EP regional
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Patent Application No. PCT/EP2023/068232, filed Jul. 3, 2023, which in turn claims priority to European Patent Application No. 22186392.1, filed Jul. 22, 2022, each of which is incorporated by reference herein, in the entirety and for all purposes.

Continuations (1)
Number Date Country
Parent PCT/EP2023/068232 Jul 2023 WO
Child 19033033 US