Automatic injector with a squeezing mechanism

Abstract

The present invention relates to an automatic injector comprising: a housing (125) configured to receive a reservoir (120) having a fluid; and a squeeze mechanism (105) configured to force fluid therethrough from the reservoir (120) towards an outlet (180) of the automatic injector during a dispensing operation.

Description

Technical Field

[0001] The present disclosure relates to an autoinjector.

Background Art

[0002] In conventional drug delivery devices, a single drive mechanism that can be housed in the housing of the drug delivery device is used in combination with several cartridges, syringes, or ampoules to dispense the drug contained in the cartridge, syringe, or ampoule from the device.

[0003] However, this type of device is designed to accommodate cartridges and syringes, and because they are rigid components, due to the shape of those components, the overall shape of the device is applied to the syringe, cartridge, or ampoule. That is usually a determining or at least a constraining factor for the form factor of the device.

Summary of the Invention

Problems to be Solved by the Invention

[0004] One object of the present disclosure is to provide an alternative autoinjector. That object is achieved by the present disclosure, in particular by the subject matter of the independent claims. Advantageous embodiments and improvements are according to the dependent claims.

Means for Solving the Problems

[0005] The present disclosure relates to an autoinjector comprising a housing configured to receive a reservoir having a fluid, for example a liquid, and a squeezing mechanism configured to squeeze the fluid through the reservoir from the reservoir towards the outlet of the autoinjector during a dispensing operation.

[0006] Using a compression mechanism to push fluid from the reservoir to the outlet has the advantage that the amount of fluid that can be moved and delivered through the needle can be controlled by the compression mechanism. Furthermore, there is some freedom in selecting the shape of the reservoir; for example, it can have a different shape from a syringe.

[0007] In one embodiment, the compression mechanism includes a movable element that mechanically interacts with a reservoir such that the movement of the movable element causes compression of the reservoir, pushing at least a portion of the fluid out of the reservoir toward the outlet.

[0008] In one embodiment, the movable element includes or is a roller, which is configured to rotate around a rotation axis while simultaneously rotating around a roller axis, thereby compressing the reservoir. The rolling function of the roller reduces the resistance caused by friction between the roller and the reservoir while the roller is moving around the rotation axis. The roller axis is the main axis of the roller and is positioned at an angle with respect to the rotation axis.

[0009] In one embodiment, the roller includes a cylindrical or conical shape, where the cone widens radially outward with respect to the axis of rotation.

[0010] In one embodiment, the housing may have a shape having a base, the diameter of which is greater than the height extending along the axis of rotation. In one embodiment, the shape includes a cylinder, specifically a cylinder with a rounded edge.

[0011] In one embodiment, the reservoir is circumferentially positioned around the axis of rotation and is oriented along an arc so that the fluid contained in the reservoir can be pushed toward the outlet by the rotation of a movable element, which involves a rotation of less than a full rotation around the axis of rotation. This represents a simple configuration, and the amount of fluid to be released is related to the amount of fluid in the reservoir. Furthermore, the energy required to release all the fluid from the reservoir to the needle is smaller compared to systems where the movable element requires several rotations.

[0012] In one embodiment, the reservoir includes a pouch or another hollow-shaped body configured to move fluid through it. The pouch can be made collapsible.

[0013] In one embodiment, the reservoir comprises a flexible material such as a flexible plastic, the material being crushable, that is, the reservoir may be elastically indeformable. That is, when deformed, the reservoir maintains its deformed shape. The pouch may contain two or more materials that are particularly suitable for its inside and outside according to chemical and / or mechanical requirements. For example, with respect to the outside of the pouch, the material may be mechanically robust against the pressure applied to the pouch by compression. With respect to the inside of the pouch, a material that does not participate in chemical reactions with the fluid contained in the pouch may be required.

[0014] The use of a flexible reservoir offers the advantage of improved robustness compared to glass syringes, which are fragile and prone to breakage. Furthermore, because the reservoir contains only one opening on the injection side that requires sealing, drug integrity is improved and the risk of contamination is reduced. In auto-injectors with syringes, for example, the stopper side must also be sealed.

[0015] Another advantage is that the reservoir can be adjusted to match the device's form factor, allowing for different configurations with improved operability. Its compactness and consistency reduce injection variability by avoiding large pre-filled syringe (PFS) tolerances. Specifically, the reservoir can be made of plastic instead of glass, which can be manufactured with greater precision than glass. Furthermore, since no stopper is required, there is a lower risk of stalling and no stopper friction. The reservoir can be filled by vacuum filling, which removes any air present, or by vapor purging before closing the container. In the case of vacuum filling, the pouch can be separated (for example, by vacuum), which creates a vacuum inside the pouch. This pulls the liquid from the connected container into the pouch.

[0016] In one embodiment, the outlet includes a needle.

[0017] In one embodiment, the auto-injector includes a spring, which is configured to rotate around a pivot axis and is mechanically coupled to a movable element to move the movable element around the pivot axis. Thus, the release of fluid through the reservoir and needle is automated to some extent and therefore easy for the patient to use. The spring can be biased when assembled with the movable element. The spring can be activated using a trigger, so that its stored potential energy is converted into kinetic energy, thereby driving the movable element. The movable element then pushes the fluid from the reservoir to the needle. Depending on the configuration of the spring relative to the stored energy, the total distance of movement of the spring and the movable element can be determined. By predetermining the distance the movable element moves, the amount of fluid that can be pushed through the reservoir and needle can be indirectly predetermined. If the fluid is related to a drug, the dose of the drug can be adjusted, for example, by the size of the reservoir. These adjustments can be made during the device assembly process. Once the device is assembled, the dose supplied by its configuration is released.

[0018] A spring can support a moving element. For example, a portion of the spring can extend into the moving element. A roller shaft can extend through and / or parallel to that portion of the spring.

[0019] In one embodiment, the spring includes a torsion spring, which is configured to move the movable element around the axis of rotation by less than one rotation of the movable element around the axis of rotation, such that the fluid contained in the reservoir is moved toward the outlet. The torsion spring is easy to control, has a compact shape, and the mechanical energy it can release can be predetermined.

[0020] In one embodiment, the housing includes a support element, and the reservoir is positioned between the support element and the movable element such that the reservoir is pressed toward the surface of the support element when the reservoir is compressed by the movable element. This not only ensures that a portion of the fluid is moved, but also ensures that the force of the movable element toward the reservoir is reliably transmitted to perform the compression, and as a result, the fluid moves through the reservoir. The support element may include a plate having a flat surface.

[0021] The support element may include, or may be, a projection extending from the bottom of the housing toward the reservoir. Each support element or projection may extend along a curve parallel to the curve along which the reservoir extends. For example, the support element is positioned along a circular element parallel to the circular element along which the reservoir is positioned.

[0022] For example, the width of the support element measured at the highest point of the protrusion may be smaller than the width of the reservoir. The width of the reservoir is, for example, the maximum width of the reservoir.

[0023] In one embodiment, the auto-injector includes a delivery tube, which is in fluid communication with a reservoir and is positioned between the reservoir and the outlet so that the delivery tube replenishes the outlet with the fluid supplied by the reservoir during the drug dispensing operation.

[0024] The reservoir preferably has a diameter larger than that of the delivery tube. When the amount of fluid is larger and the diameter of the reservoir is larger, fluid pressure from the reservoir to the delivery tube is generated. As soon as the fluid is moved outside the delivery tube, a continuous flow of fluid from the reservoir to the delivery tube can be established. This is important when a continuous flow of liquid is essential and at the same time a drug dosing is carried out which requires ensuring a predetermined dose.

[0025] In one embodiment, the reservoir includes a tapered portion which connects the reservoir and the delivery tube. The tapered portion ensures that the amount of fluid that is pushed into the delivery tube and not released from the reservoir is minimized.

[0026] In one embodiment, the auto-injector includes an outlet drive mechanism which - an outlet, and - an interface element that is connected or integrated with the outlet and is movable along a rotation axis from a first axial position to a second axial position, - a trigger operably connected to the interface element and movable along the rotation axis from a first trigger position to a second trigger position and includes ○ In the first trigger position, the movement of the interface element from the first axial position to the second axial position is releasably locked, ○ In the second trigger position, the interface element is movable to the second axial position, ○ By the movement of the trigger from the first trigger position to the second trigger position, the interface element is released from the first axial position and becomes movable to the second axial position.

[0027] The exit may include a needle. The interface element may include at least one interface function. The interface element may include a needle holder. The interface function may include a needle holder surface, which is positioned on the needle holder and oriented perpendicular to the axis of rotation. Preferably, the needle holder includes a needle holder ledge, and the needle holder surface is positioned on the needle holder ledge. The needle holder may include two needle holder ledges, which are positioned opposite each other with respect to the axis of rotation, and each includes a needle holder surface. The needle holder may include a cylindrical body, the axis of which is the axis of rotation. The two needle holder ledges are positioned radially outward of the cylindrical body of the needle holder. The needle holder may include mechanical guides, such as axial grooves radially outward of the cylindrical body, for guiding the movement of the trigger along the axis of rotation.

[0028] A trigger may include a button, one or more trigger arms, and one or more trigger interfaces. The trigger arms may extend from the button. Preferably, the trigger includes two trigger arms. The trigger interfaces are located at the ends of the trigger arms. The trigger interfaces may include inclined trigger surfaces.

[0029] As the trigger moves along the axis of rotation, the trigger arm can be guided by the mechanical guide of the needle holder, and the mechanical guide of the needle holder prevents the trigger arm from rotating. The trigger arm can also be prevented from rotating by a base element, which includes a mechanical guide and is fixed to or integrated with the device housing. The base element can include a base element body, which is fixed to or integrated with the housing. The base element body can include a hole, which can be positioned on the axis of rotation and configured so that a needle can move through the hole along the axis of rotation. The hole can be sealed by a sealing portion that seals the hole and the housing from the outside. The needle can penetrate the sealing portion when it is moved in the direction of the hole by a drive spring. The base element can include a base element arm, which extends from the base element body toward the inside of the device housing. The base element arm is positioned around the axis of rotation and spaced apart to have a gap between them. The spacing between the base element arms is configured, in the assembled state, to receive the radially outer members of the trigger arm to guide them axially. In the assembled state, the needle holder ledge is received in the other spacing between the base element arms and is immobile relative to the base elements, and since the base elements are fixed to or integrated with the housing, the needle holder ledge and needle holder are immobile relative to the housing.

[0030] When the trigger is moved from the first trigger position to the second trigger position, the exit drive mechanism enables the release of the needle so that it moves to a certain position for injection. To avoid accidental movement of the needle, the needle holder is locked in the first axial position until the trigger is moved to its second trigger position.

[0031] In one embodiment, the automatic syringe includes a retaining element, the retaining element being in mechanical contact with an interface element. - The retaining element is rotatable around the axis of rotation from a blocked position to a released position relative to the interface element. - In the block position, the interface element is locked so that its movement from the first axial position to the second axial position can be released by the holding element. - In the released position, the interface element is movable from a first axial position to a second axial position. - The trigger movement from the first trigger position to the second trigger position causes the holding element to rotate from the blocked position to the released position.

[0032] The retaining element may include at least one first retaining interface configured to interact with one of the trigger surfaces. The retaining element may include a collar. The collar includes one or more collar trigger arms, preferably two trigger arms, which are positioned opposite each other with respect to the axis of rotation. One or more collar trigger arms include the first retaining interface. The first retaining interface may include a first retaining surface, which may be an inclined retaining surface, and which may be a trigger interface, which may be an inclined trigger surface along the axis of rotation. The inclined trigger surface is configured to interact with the inclined retaining surface. The inclined trigger surface and the inclined retaining surface are configured and oriented to slide on each other. When the trigger is moved from a first trigger position to a second trigger position, the inclined trigger surface and the inclined retaining surface come into mechanical contact such that the inclined trigger surface is pressed against the inclined retaining surface. As these surfaces slide against each other, the axial motion of the trigger arm and the inclined trigger surface, which apply axial force to the inclined retaining surface and the collar trigger arm, causes the collar trigger arm and collar to rotate around the axis of rotation. The rotation of the collar is relative to the needle holder and needle holder ledge, which are otherwise immobilized.

[0033] It is also possible for only one of the trigger surface or the retaining surface to be inclined.

[0034] The retaining element further includes at least one second retaining interface, the second retaining interface configured to interact with the interface element and, specifically, with good interface functionality on the surface of the needle holder ledge. The retaining element may include one or more collar retaining arms, preferably two, which are positioned opposite each other with respect to the axis of rotation. Each collar retaining arm includes a second retaining interface, the second retaining interface may include a second retaining surface. Each second retaining surface faces the needle holder surface with good interface functionality. In the first axial position of the needle holder, the needle holder surface is in mechanical contact with the second retaining surface so that the needle holder surface slides on the second retaining surface as the collar retaining arm rotates relative to the needle holder. Thereafter, the second retaining surface blocks the axial movement of the needle holder surface.

[0035] One or more collar trigger arms and one or more collar retaining arms are arranged alternately around the axis of rotation, with a certain spacing between each adjacent collar trigger arm and collar retaining arm. This spacing is configured to accommodate the needle holder ledge and / or trigger arm.

[0036] In the assembled state of the outlet drive mechanism, the collar is positioned inside the volume enclosed by the base element arm so that it can rotate within the base element.

[0037] When the trigger is moved from the first trigger position to the second trigger position, the force applied to the collar trigger arm causes it to rotate relative to the needle holder and needle holder ledge. The rotation continues until the needle holder ledge faces the spacing of the collar.

[0038] Furthermore, the needle holder ledge's axial movement is blocked by the collar retaining arm at the first axial position of the needle holder. Additionally, in the release position of the retaining element, the drive spring moves the needle holder to a second axial position. The collar's blocked and released positions differ only in rotation / angle, not axial position.

[0039] The trigger interface is further configured to convert the axial motion of the trigger and its interface into rotational motion of the holding element. The trigger interface may include an arm extending along the axis of rotation so as to be able to mechanically interact with the collar.

[0040] The collar provides additional safety against accidental needle movement. The needle holder is released only when the collar is subjected to rotational motion, and this rotational motion depends on the axial motion of the trigger. The needle holder is immobile and therefore cannot rotate on its own. Furthermore, in the collar's blocked position, the surface of the collar retaining arm is pressed toward the surface of the needle holder ledge by a compressed drive spring. This ensures that the collar cannot rotate accidentally.

[0041] In one embodiment, the automatic syringe includes an outlet drive unit, the outlet drive unit being operably connected to a trigger and interface element, - The exit drive unit is configured to supply energy to move the interface element from a first axial position to a second axial position, and the exit drive unit has a first drive unit state and a second drive unit state. - In the first drive unit state, energy is stored in the exit drive unit, the interface element is in the first axial position, the retaining element is in the block position, and the interface element is prevented from moving to the second axial position. - In the second drive unit state, when the holding element is in the released position, the exit drive unit can transfer energy to the interface element so that the interface element moves along the axis of rotation from the first axial position to the second axial position. - The trigger movement from the first trigger position to the second trigger position causes the output drive unit to change from the first drive unit state to the second drive unit state.

[0042] The exit drive unit may include a drive spring. The drive spring may be positioned between the trigger and the needle holder along the axis of rotation. When the needle holder is in a first axial position, the drive spring is in a first drive unit state in which the drive spring is compressed. When the needle holder is released and can move to a second axial position, the drive unit is in a second drive unit state in which the drive spring is extended and can transmit mechanical energy to the needle holder. Under the force of the extending drive spring, the needle holder moves along the axis of rotation to its second axial position.

[0043] When the release of the needle holder is initiated by the trigger, the needle holder is then moved to a second axial position by a drive spring. This second axial position can be the position for injection and drug delivery. Thus, the trigger initiates an automatically occurring injection, and the drive spring drives the release of the needle holder when the trigger initiates it.

[0044] In one embodiment, the trigger can also cause the administration of a fluid.

[0045] In one embodiment, the housing may have a shape having an overall base, the base having a diameter greater than the height extending along the longitudinal axis. In one embodiment, the shape includes a cylinder, specifically a cylinder with a rounded edge.

[0046] In one embodiment, the automatic syringe includes a reservoir containing a drug or medication.

[0047] In one embodiment, the auto-injector is a disposable or single-use device for dispensing a single dose.

[0048] Here, an embodiment will be described as a simple example, with reference to the attached drawings. [Brief explanation of the drawing]

[0049] [Figure 1A] This shows schematic top views of an automatic syringe from various angles. [Figure 1B] This shows schematic top views of an automatic syringe from various angles. [Figure 1C] This shows schematic top views of an automatic syringe from various angles. [Figure 2] A side cross-sectional view of an automatic syringe is shown. [Figure 3A] A side cross-sectional view of the compression mechanism is shown. [Figure 3B] A top cross-sectional perspective view of the compression mechanism is shown. [Figure 4A] The exploded view of the needle drive mechanism is shown. [Figure 4B] The diagram shows a needle drive mechanism in its first state, assembled with a drive spring and a base element. [Figure 4C] A diagram of a needle drive mechanism having a drive spring in the first state is shown. [Figure 4D] A diagram of a needle drive mechanism having a drive spring in the second state is shown. [Modes for carrying out the invention]

[0050] Throughout the diagram and the following description, the same reference number corresponds to the same configuration.

[0051] Figures 1A to 1C show schematic top views of the components of an automatic syringe from various angles. As an example related to Figures 1A to 1C, Figure 1A will be described below.

[0052] Figure 1A shows a top view of one embodiment of the automatic syringe 100. The figure shows the compression mechanism 105. A roller 130 is rotatably positioned around a rotation axis Xro. During rotation, the roller 130 also rotates around its own roller axis Zrol, which is positioned at a certain angle toward the rotation axis Xro. The roller 130 rolls in the opposite direction to the rotation around the rotation axis Xro. The roller 130 is configured to compress a pouch 110, which contains a fluid material, such as a liquid drug or pharmaceutical preparation. The pouch 110 is positioned around the rotation axis Xro so as to include an arc cross-section. The pouch 110 is positioned radially away from the rotation axis Xro so that the roller 130 can compress the pouch 110 during rotation. One end of the pouch 110 is in fluid contact with a needle 180. The terminal end includes a tapered section 120, which is in fluid communication with a delivery tube 160. The delivery tube 160 is in fluid communication with a needle 180. An additional spout 165 can be provided to connect the delivery tube 160 and the tapered section 120. The spout 165 enables the connection between the pouch 110 and the delivery tube 160. The spout 165 has different material properties than the pouch 110. For example, it is stiffer so that the alignment of the pouch 110 within the housing 125 is based on the position and orientation of the spout 165. The delivery tube 160 extends radially inward from the pouch 110 to a position where it connects with the needle 180. The needle 180 is located inside a spring 150 and extends along the axis of rotation Xro. The fluid compressed by the roller 130 moves further within the pouch 110 to the tapered section 120, and then through the delivery tube 160 to the needle 180. The fluid in the pouch 110 can be released through the needle 180.

[0053] The roller 130 compresses along the entire length of the pouch 110. It is also possible for the roller 130 to stop before the entire length of the pouch 110 is compressed. However, in that case, at least a portion of the tapered member 120 is compressed. Since the pouch 110 is positioned to include the cross-section of the entire arc, the length compressed by the roller 130 corresponds to the length of that arc. Generally, the roller 130 compresses a length less than the entire circumference. When the roller 130 has compressed the entire length of the arc, it is stopped by a roller stopper 140 located at the end of the tapered portion 120. In this way, the fluid in the pouch 110 is extracted by compression by the roller 130 within the circumferential length of the arc. Furthermore, the roller 130 has a predetermined stopper to prevent uncontrolled movement. The roller stopper 140 can be a block with a rectangular cross-section, including metal or plastic. The roller stopper 140 can be mounted on the housing 125.

[0054] The pouch 110 is positioned on the plate 170, which includes a flat surface facing the pouch 110, so that the pouch 110 is positioned between the plate 170 and the roller 130 during the compression operation. During the compression operation, the roller 130 presses the pouch 110 toward the plate 170. In this situation, the plate 170 supports the pouch 110 and ensures that the force applied to the pouch 110 from the roller is transmitted to the movement of the liquid inside the pouch 110.

[0055] The plate 170 can be mounted inside the housing 125. The plate 170 and the housing 125 may be manufactured as a single piece, or they may be made as separate components.

[0056] The automatic syringe 100 further includes a spring 150, which is mechanically coupled to a roller 130 and drives the roller 130 around a rotation axis Xro, thereby moving the roller 130 itself around a roller axis Zrol. The spring 150 is preferably biased during assembly so that the energy required for the squeezing and dispensing operations is released, for example, by a user triggering the spring 150 in order to drive the roller 130 around the rotation axis Xro. The spring 150 may be a torsion spring 150. The spring 150 is positioned around the rotation axis Xro within the arc of the pouch 110.

[0057] The roller 130 may have a cylindrical or conical shape. The pouch 110 can be a pouch that, if deformed after compression, does not return to its original shape but maintains its deformed state, specifically a collapsible pouch.

[0058] Figure 2 shows a side cross-sectional view of an automatic syringe. The compression mechanism 105 is located within the housing 125. The housing 125 may include two members joined together. The housing 125 includes a needle opening 185 so that the needle can move at least partially along the rotation axis Xro and extend from the housing 125, preferably from a position fully retracted into the housing. For example, when the automatic syringe is used for injection and pressed against the patient's skin, the needle 180 can directly pierce the skin from the automatic syringe through the needle opening 185. The needle opening 185 must be sealed so that the needle 180 meets the cleanliness requirements of the needle 180 for medical use. The movement of the needle 180 is triggerable via a trigger opening 190 located in the housing 125. A user or patient of the automatic syringe can trigger an injection by pressing a button (not shown here) through the trigger opening 190, thereby initiating the movement of the torsion spring 150 or the needle 180 by the needle drive mechanism 300.

[0059] The housing 125 has a cylindrical shape with rounded edges. The rounded edges are advantageous in avoiding injury to the patient's skin from sharp edges. The rotation axis Xro includes the axis of the cylinder.

[0060] The housing 125 also includes a window 195 for monitoring the progress of the compression operation and indicating the end of the compression operation or the end of injection.

[0061] An auto-injector is a disposable or single-use device for dispensing a single dose.

[0062] Figure 3A shows a side cross-sectional view of an automatic syringe. In addition to the previous figure, a pouch cross-section 115 is shown, which can be elliptical. It is also possible for the pouch 110 to be made of two components of material that are bonded together. These two components can include the entire length of the pouch 110. When the pouch cross-section is elliptical, the major axis of the ellipse intersects the area where the two components of the pouch 110 are bonded together. A pouch 110 with an elliptical pouch cross-section 115 has the advantage that its width is greater than its height, and therefore a cylindrical or conical roller 130 can compress the pouch 110 more efficiently compared to a circular pouch cross-section 115 with a greater height.

[0063] Figure 3B shows a schematic top cross-sectional perspective view of the compression mechanism without the torsion spring 150.

[0064] Figure 4A shows a detailed exploded view of the needle drive mechanism 300.

[0065] The needle drive mechanism 300 includes a trigger button 320, a drive spring 310, a needle holder 340, a collar 360, and a base element 400. The needle 180 is mechanically connected to the needle holder 340.

[0066] The trigger button 320 includes a trigger button body 325 and two trigger button arms 330 extending from the trigger button body 325 along the rotation axis Xro. The trigger button body 325 includes a cylindrical shape, with a height or thickness less than its diameter, forming an overall disc-like shape. The trigger button body 325 may also include any other shape, such as a thin rectangular or square plate. The trigger button body 325 can be coupled to or integrated with the device housing 105 and may have the same thickness as the housing 105. The two trigger button arms 330 are positioned opposite each other with respect to the rotation axis Xro. Each trigger button arm 330 includes a radially outer member and a radially inner member. Each trigger button arm 330 includes an inclined surface at the end away from the trigger body 325 with respect to the rotation axis Xro. The inclined surface is located on the radially inner member.

[0067] The drive spring 310 is positioned between the trigger button body 325 and the needle holder 340 along the rotation axis Xro, and is extendable and compressible along the rotation axis Xro. The collar 360 can be positioned inside the base element 400. When the drive spring 310 is compressed, the needle holder 340 is positioned between the collar 360 and the drive spring 310.

[0068] The needle holder 340 includes a cylindrical body and two needle holder ledges 350, the needle holder ledges 350 extending radially outward from the body and positioned on both sides with respect to the rotation axis Xro. The needle holder 340 is operably coupled to the drive spring 310 so that when the drive spring 310 extends along the rotation axis Xro, the needle holder 340 and the needle 180 move away from the trigger button body 325 along the rotation axis Xro. The needle holder ledges 350 may have a wedge shape, with their cross-sections decreasing radially inward.

[0069] The collar 360 includes a collar base 365, two collar retaining arms 380, and two collar trigger arms 390. The two collar retaining arms 380 and the two collar trigger arms 390 each extend from the collar base 365 toward the trigger button body 325 along the rotation axis Xro. The two collar retaining arms 380 are positioned on opposite sides of the rotation axis Xro. The two collar trigger arms 390 are positioned on opposite sides of the rotation axis Xro. The collar retaining arms 380 and the collar trigger arms 390 are arranged alternately around the rotation axis Xro and spaced apart by the collar spacing 370. The collar retaining arms 380 include a rectangular shape. The collar trigger arms 390 also include a rectangular base shape, but have an inclined surface at their ends, which faces away from the collar base 365 and opposite the inclined surface of the radially inner member of the trigger button arm 330. It is also possible that either the trigger button arm 330 or the collar trigger arm 390 includes an inclined surface. For example, if only the trigger button arm 330 includes an inclined surface, that inclined surface pushes against the edge of the collar trigger arm, causing it to move further along the rotation axis Xro, and this movement along the rotation axis Xro also rotates the collar 360. The collar base 365 includes a hole, so that the needle 180 can move through the hole along the rotation axis Xro.

[0070] The base element 400 includes a base element body 405 and four base element arms 410, each of which extends along the rotation axis Xro from the base element body 405 toward the trigger button body 325. The base element body 405 includes a cylindrical shape, with a height or thickness less than its diameter, forming an overall disc-like shape. The base element body 405 may also include any other shape, such as a thin rectangular or square plate. The base element body 405 can be attached to or integrated with the device housing 105. The base element arms 410 extend from the base element body 405 along the rotation axis Xro and are positioned around the rotation axis Xro, thereby enclosing a volume configured to receive the collar 360 when the needle drive mechanism 300 is assembled. The base element arms 410 are spaced apart from each other by a distance 420. Two of the gaps 420 are configured to receive the radially outer member of the trigger button arm 330 so that the trigger button arm 330 is guided axially within the gap 420 but is not rotatable. The other two gaps are configured to receive the needle holder ledge 350 along the rotation axis Xro, in which case the needle holder ledge 350 is not rotatable. The base element body 405 includes a hole so that the needle 180 can move out of the device along the rotation axis Xro through the hole for injection. The hole can be sealed with a sealing portion through which the needle can pass.

[0071] Figure 4B shows the needle drive mechanism 300 in its assembled state. The drive spring 310 is compressed between the trigger button 320 and the needle holder 340 with respect to the rotation axis Xro so that the drive spring 310 biases the needle holder 340. The trigger button arm 330 is partially inserted into the base element spacing 420 so that it can move along the rotation axis Xro, and is guided by the base element arm 410 which forms the base element spacing 420. When the trigger button arm 330 is axially movable within the base element spacing, it is immobilized by the base element arm 410.

[0072] Alternatively, the trigger button arm 330 can be immobilized by a needle holder 340. The cylindrical body of the needle holder 340 may include an additional groove oriented along the axis of rotation Xro and configured to mechanically guide the trigger button arm 330 along the axis of rotation Xro, thereby immobilizing the arm 330.

[0073] The needle holder ledge 350 is positioned in the same manner at the base element spacing 420. Thus, the needle holder ledge 350 is immobilized by the base element 400, and if the base element 400 is a component of the device housing 105, then the needle holder ledge 350 and the needle holder 340 are immobilized by the housing 105. Furthermore, the needle holder ledge 350 is axially blocked by the collar 360, which is positioned within the space enclosed by the base element arm 410.

[0074] The needle holder 340 includes a hole for receiving a pipe (not shown). The hole can be directed radially inward from the needle holder ledge 350. The pipe is in fluid contact with the needle 180 and the delivery tube 160. In this way, the fluid in the pouch 110 can be transferred to the needle 180 for drug administration.

[0075] Figure 4C shows the assembled needle drive mechanism 300 without the base element 400. In the figure, the drive spring 310 is compressed between the trigger button 320 and the needle holder 340 with respect to the rotation axis Xro such that the drive spring 310 biases the needle holder 340. The needle holder 340 is positioned between the drive spring 310 and the collar 360 with respect to the rotation axis Xro. The needle holder ledge 350 is in mechanical contact with the end surface of the collar retaining arm 380 such that the force of the compressed drive spring 310 acts on the collar retaining arm 380 through the needle holder ledge 350. The trigger button arm 330 is positioned radially outward relative to the drive spring 310 and the needle holder 340. The end of the trigger button arm 330 is opposite to the end of the collar trigger arm 390, but spaced apart in the axial direction. Both the end of the trigger button arm 330 and the end of the collar trigger arm 390 include inclined surfaces. Therefore, when the inclined surface of the trigger button arm 330 is pressed against the surface of the collar trigger arm 390, these surfaces slide toward each other. As the trigger button arm 330 moves further along the rotation axis Xro, a force is applied to the collar trigger arm 390, causing the collar trigger arm 390 and the collar 360 to rotate.

[0076] Figure 4D shows a diagram of the assembled needle drive mechanism 300 without the base elements. In the diagram, the drive spring 310 is extended along the rotation axis Xro. The needle holder 340 is moved away from the trigger button body 325 along the rotation axis Xro by the force of the extending drive spring 310. As a result, the needle holder ledge 350 engages with the collar gap 370, thereby guiding the movement of the needle holder 340 along the rotation axis Xro.

[0077] When the needle drive mechanism 300 is in the state shown in Figure 4B or Figure 4C, that is, when the drive spring 310 is compressed and the movement of the needle holder 340 away from the trigger button body 325 is blocked, the trigger button arm 330 is moved toward the collar trigger arm 390 when the trigger button 320 is pressed toward the drive spring 310 along the rotation axis Xro. When the inclined surface of the trigger button arm 330 is pressed toward the surface of the collar trigger arm 390, the axial motion of the trigger button arm 330 causes the collar trigger arm 390 and the collar 360 to rotate. The rotation of the collar 360 is relative to the needle holder ledge 350. As the collar 360 rotates, the collar retaining arm 380 also rotates relative to the needle holder 340. During such rotation, the needle holder ledge 350 is biased axially toward the collar retaining arm 380 by the drive spring 310. The rotation of the collar retaining arm 380 continues until the collar gap 370 faces the needle holder ledge 350. At that point, the needle holder ledge 350 is no longer blocked by the collar retaining arm 380, and the trigger button arm 330 is disengaged from the collar trigger arm 390. At that time, the needle holder 340 moves axially away from the trigger button body 325. The collar retaining arm 380 is longer than the collar trigger arm 390. It is also possible that the collar retaining arm 380 is the same length as the collar trigger arm 390. In that case, the trigger button arms 330 need to be adjusted to their lengths. The needle holder ledge 350 then engages with the collar gap 370, and the needle holder 340, under the force of the extending drive spring 310, moves together with the needle 180 away from the trigger button body 325 towards the base element 400 and further toward the injection site.

[0078] The device can have a height of 10–40 mm, particularly 15–30 mm. The base of the device can have a diameter of 45–90 mm, particularly 50–70 mm. Specifically, the height of the device can be less than one-third the size of a typical auto-injector including a syringe. This is advantageous for users such as patients because the distance from the skin to the point where the device is triggered is much smaller.

[0079] The scope of protection is not limited to the examples given herein. Any invention disclosed herein is embodied in novel features and combinations of features, including, in particular, any combination of any configuration described in the claims, even if such configuration or combination of configurations is not expressly shown in the claims or examples.

[0080] The terms “drug” or “pharmaceutical” are used synonymously herein to describe a pharmaceutical preparation comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API") is, in its broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical is used to treat, cure, prevent or diagnose a disease, or otherwise improve physical or mental well-being. Drugs or pharmaceuticals may be used for a limited duration or, in the case of chronic disorders, regularly.

[0081] As described below, drugs or pharmaceuticals may contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules, polypeptides, peptides, and proteins with molecular weights of 500 Da or less (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (e.g., antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also intended.

[0082] Drugs or pharmaceuticals can be contained in a primary package or “drug container” adapted for use in a drug delivery device. A drug container may be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide chambers suitable for storing one or more drugs (e.g., short-term or long-term storage). For example, in some cases, a chamber may be designed to store a drug for at least one day (e.g., one day to at least 30 days). In some cases, a chamber may be designed to store a drug for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or refrigerated temperature (e.g., about -4°C to about 4°C). In some cases, a drug container may be or include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs) one in each chamber individually. In such cases, the two chambers of a dual-chamber cartridge can be configured to allow mixing of two or more components before and / or during administration to a human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and, optionally, to allow mixing of the two components by the user before administration. Alternatively or additionally, the two chambers can be configured to allow mixing of the components at the time of administration to a human or animal body.

[0083] The drugs or agents contained in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), anguina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are listed in handbooks such as Rote Liste 2014 (for example, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0084] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or human insulin analogs or derivatives; glucagon-like peptides (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, their analogs or derivatives; dipeptidyl peptidase-4 (DPP4) inhibitors; or pharmaceutically acceptable salts or solvates thereof; or mixtures thereof. As used herein, the terms “analog” and “derivative” refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, such as the structure of human insulin, by the deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or the addition of at least one amino acid residue. The added and / or replaced amino acid residue may be any of the coding amino acid residues, other naturally occurring residues, or purely synthetic amino acid residues. Insulin analogs are also called “insulin receptor ligands.” In particular, the term “derivative” refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, such as a polypeptide having the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are bonded to one or more amino acids. In some cases, one or more amino acids present in a naturally occurring peptide are deleted and / or replaced by other amino acids, including non-coding amino acids, or amino acids are added to a naturally occurring peptide, including non-coding ones.

[0085] Examples of insulin analogs include Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which proline at position B28 may be replaced with Asp, Lys, Leu, Val or Ala and Lys at position B29 may be replaced with Pro; Ala(B26) human insulin; Des(B28~B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0086] Examples of insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir (registered trademark)); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; and B30-N-myristoyl-ThrB29LysB30 human insulin. These are B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba (registered trademark)); B29-N-(N-litocoryl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0087] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of Hiramonster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), and r-exendin -4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C, CM-3, GLP-1 Erigen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexene, Biador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN, and Glucagon-XTEN.

[0088] An example of an oligonucleotide is mipomersen sodium (Kynamro®), a cholesterol-lowering antisense agent used to treat familial hypercholesterolemia.

[0089] Examples of DPP4 inhibitors include vidagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0090] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, choriongonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadrelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0091] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or their derivatives, or sulfated polysaccharides, such as the polysulfated forms of the aforementioned polysaccharides, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives are Hylan G-F20 (Synvisc®) and sodium hyaluronate.

[0092] As used herein, the term “antibody” refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind to antigens. Antibodies may be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies may have effector function and be complement-immobilized. In some embodiments, antibodies may have reduced or no ability to bind to Fc receptors. For example, antibodies may be isotypes or subtypes, antibody fragments, or mutants that do not support binding to Fc receptors, for example, having mutations or deletions in the Fc receptor-binding region. The term “antibody” also includes antigen-binding molecules based on quadrivalent bispecific tandem immunoglobulins (TBTIs) and / or bivariable-region antibody-like binding proteins (CODVs) with crossover binding region orientation.

[0093] The terms “fragment” or “antibody fragment” refer to polypeptides derived from antibody polypeptide molecules (e.g., antibody heavy chain and / or light chain polypeptides) that do not contain the full-length antibody polypeptide but still contain at least a portion of a full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may include cleavage portions of the full-length antibody polypeptide, but the term is not limited to such cleavage fragments. Examples of antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-stranded Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, e.g., bispecific, trispecific, quadrispecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, e.g., bivalent, trivalent, quadrivalent and multivalent antibodies, minibodies, chelated recombinant antibodies, tribodies or vibodies, intrabodies, nanobodies, small module immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0094] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light polypeptides that primarily mediates specific antigen recognition. The term "framework region" refers to an amino acid sequence within the variable region of both heavy and light polypeptides that is not a CDR sequence and primarily maintains the proper arrangement of the CDR sequence to enable antigen binding. While the framework region itself is typically not directly involved in antigen binding, as is known in the art, certain residues within the framework region of a particular antibody may directly participate in antigen binding or influence the interaction ability of one or more amino acids in the CDR with the antigen.

[0095] Examples of antibodies include anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0096] Any pharmaceutically acceptable salt of any API described herein is intended for use in drug delivery devices with drugs or pharmaceuticals. Examples of pharmaceutically acceptable salts include acid addition salts and basic salts.

[0097] Without departing from the full scope and spirit of the present invention, various modifications (additions and / or omissions) of the components, formulations, apparatus, methods, systems, and embodiments of the API described herein may be made, and those skilled in the art will understand that the present invention encompasses such modifications and all their equivalents.

[0098] This patent application claims priority to European Patent Application No. 20315495.0, the disclosure of which is incorporated herein by reference. [Explanation of symbols]

[0099] 100 auto-injector 105 Compression mechanism 110 pouches 115 Pouch cross-section 120 Tapered part 125 Housing 130 Laura 140 Low Top 150 Torsion springs 160 delivery tubes 165 Spout 170 Plates 180 needles 185 Needle opening 190 Trigger opening 195 windows 300 Needle drive mechanism 310 Drive spring 320 trigger buttons 325 Trigger Button Body 330 Trigger Button Arm 340 Needle Holder 350 Needle Holder Ledge 360 Color 365 Color Base 370 color interval 380 Color Holding Arm 390 Color Trigger Arm 400 base elements 405 Base element body 410 Base Element Arm 420 base element spacing Xro rotation axis Zrol roller shaft

Claims

1. An automatic injector (100), comprising: a housing (125) configured to receive a reservoir (110) having a fluid; a squeeze mechanism (105) configured to force fluid from the reservoir (110) towards an outlet (180) of the auto-injector during a dispensing operation; The automatic injector (100).

2. 2. The automatic injector of claim 1, wherein the squeezing mechanism includes a movable element that mechanically interacts with the reservoir such that movement of the movable element causes squeezing of the reservoir to force at least a portion of the fluid from the reservoir toward the outlet.

3. 3. The automatic injector (100) according to claim 1 or 2, comprising a spring (150) including a spring portion configured to rotate about an axis of rotation (Xro) and mechanically coupled to the movable element (130) to move the movable element about the axis of rotation (Xro).

4. 4. The automatic injector (100) of claim 3, wherein the spring (150) comprises a torsion spring (150) configured to move the movable element (130) about the axis of rotation (Xro) such that the fluid contained in the reservoir (110) is moved towards the outlet in less than one revolution of the movable element (130) about the axis of rotation (Xro).

5. the reservoirs (110) are arranged circumferentially about an axis of rotation (Xro), the reservoirs being oriented along an arc such that a rotation of the movable element (130) that includes less than a full revolution about the axis of rotation (Xro) can force the fluid contained in the reservoirs (110) towards the outlet (180); and / or The automatic injector (100) of any one of claims 1 to 4, wherein the reservoir (110) comprises a collapsible pouch (110).

6. The housing (125) is arranged such that the bottom of the housing (125) faces the reservoir (110).

6. The automatic injector (100) according to any one of claims 1 to 5, comprising a support element (170) in the form of a protruding projection, the reservoir (110) being arranged between the support element (170) and the movable element (130) in such a way that when the reservoir (110) is squeezed by the movable element (130), a surface of the reservoir (110) is pressed towards the support element (170).

7. The automatic injector (100) according to any one of claims 2 to 6, wherein the movable element (130) comprises a roller (130) configured to rotate about a rotation axis (Xro) while simultaneously rotating about a roller axis (Zrol) to squeeze the reservoir (110).

8. The automatic injector of claim 7, wherein the roller (130) comprises a cylindrical or conical shape.

9. 9. The automatic injector (100) of any one of claims 1 to 8, comprising a delivery tube (160) in fluid communication with the reservoir (110) and disposed between the reservoir (110) and the outlet (180) such that the delivery tube (160) replenishes the outlet (180) with fluid provided by the reservoir (110) during a dosing operation.

10. An outlet drive mechanism (300), comprising: An outlet (180); an interface element (340) coupled to or integral with said outlet (180), said interface element (340) being movable from a first axial position to a second axial position along said axis of rotation (Xro); a trigger (320) operably coupled to the interface element (340); the trigger (320) is movable along an axis of rotation (Xro) from a first trigger position to a second trigger position; In the first trigger position, the interface element (340) is releasably locked against movement from the first axial position to the second axial position; In the second trigger position, the interface element (340) is movable to a second axial position; 10. The automatic injector of claim 1, wherein movement of the trigger (320) from the first trigger position to the second trigger position releases the interface element (340) from the first axial position and moves the interface element (340) to the second axial position.

11. a retaining element (360) in mechanical contact with the interface element (340); the retaining element (360) being rotatable about a rotation axis (Xro) from a blocking position to a release position relative to the interface element (340); In the blocking position, the interface element (340) is releasably locked against movement from the first axial position to the second axial position by the retaining element (360); In the released position, the interface element (340) is movable from a first axial position to a second axial position; 11. The automatic injector of claim 10, wherein movement of the trigger (320) from the first trigger position to the second trigger position causes the retaining element (360) to rotate from the blocking position to the release position.

12. an outlet drive unit (310) operably coupled to a trigger (320) and an interface element (340); The outlet drive unit (310) is configured to provide energy to move the interface element (340) from a first axial position to a second axial position, and the outlet drive unit (310) is configured to provide a first drive unit state and a second drive unit state. Has In a first drive unit state, the outlet drive unit (310) has energy stored therein, the interface element (340) is in a first axial position, the retaining element (360) is in a blocking position, and the interface element (340) is prevented from moving to a second axial position; in a second drive unit state, when the retaining element (360) is in a release position, the outlet drive unit (310) can transmit energy to the interface element (340) such that the interface element (340) is moved from a first axial position to a second axial position along the rotation axis (Xro); 12. The automatic injector of claim 10 or 11, wherein movement of the trigger (320) from the first trigger position to the second trigger position causes the outlet drive unit (310) to change from the first drive unit state to the second drive unit state.

13. The auto-injector (100) includes a reservoir (110) having a drug or medication; and / or The automatic injector (100) of any one of claims 1 to 12, wherein the automatic injector (100) is a disposable or single-use device for delivering a single dose.

14. 14. The automatic injector according to any one of claims 8 to 13, wherein the cone widens radially outwards relative to the axis of rotation (Xro).

15. The automatic injector according to any one of claims 6 to 14, wherein the support element (170) extends along a curve parallel to the curve along which the reservoir (110) extends.

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