Auto-injector with pump

Abstract

The present invention relates to an automatic injector comprising: a housing (105) configured to receive a working reservoir (120, 220) having a fluid; and a pump device (100, 200) configured to force fluid therethrough from the working reservoir (120, 220) towards an outlet (180) of the automatic injector during a dispensing operation.

Description

[Technical Field]

[0001] The present disclosure relates to an auto-injector having a pump. [Background technology]

[0002] In a typical drug delivery device, a single drive mechanism that can be housed in the housing of the drug delivery device is used in conjunction with several cartridges or ampoules to dispense the drug contained in the cartridges or ampoules from the device, and a cartridge holder of the device is typically releasably connected to the housing and can be removed from the housing to replace used cartridges.

[0003] However, this type of device is designed to house a cartridge and syringe, and because of the shape of those components, the overall shape of the device is adapted to the syringe and cartridge, which is typically the determining factor for the form factor of the device. Summary of the Invention [Problem to be solved by the invention]

[0004] It is an object of the present disclosure to provide an alternative auto-injector. That object is achieved by the present disclosure, in particular by the subject matter of the independent claims. Advantageous embodiments and refinements are subject to the dependent claims. [Means for solving the problem]

[0005] The present disclosure relates to an automatic injector including a housing configured to receive a working reservoir having a fluid, e.g., a liquid, and a pump device configured to force fluid therethrough from the working reservoir toward an outlet of the automatic injector during a dispensing operation.

[0006] Using a pump to force fluid from the working reservoir to the outlet has the advantage that the amount of fluid to be moved and delivered through the outlet can be controlled by the pump, and there is some freedom in choosing the shape of the reservoir, which can, for example, have a different shape than a syringe.

[0007] In one embodiment, the working reservoir comprises a tube, pipe, or another hollow shaped body configured to move fluid therethrough.

[0008] In one embodiment, the working reservoir comprises a flexible material, such as a flexible plastic, preferably an elastomer. The working reservoir may be elastically deformable; that is, when deformed, the working reservoir tends to regain its undeformed shape. This may be particularly appropriate, for example, in the case of a peristaltic pumping device, where the pumping device involves deforming the working reservoir during its operation. The pouch may comprise two or more materials that are particularly compatible on its interior and exterior according to chemical and / or mechanical requirements. For example, for the exterior of the pouch, the material may be mechanically robust against pressures applied to the pouch by squeezing. For the interior of the pouch, a material that does not participate in chemical reactions with the fluid contained in the pouch may be required.

[0009] In one embodiment, the outlet includes a needle that can be used to administer medication to a patient.

[0010] In one embodiment, the pumping device includes a movable element operatively coupled to the working reservoir such that movement of the movable element forces at least a portion of the fluid from the working reservoir to the needle. The movable element can be configured to perform repeated, preferably cyclic, repetitive movements such that a portion of the fluid is moved from the working reservoir to the needle with each repetition. The total amount of fluid moved from the working reservoir to the needle can then be determined by the number of repetitions.

[0011] In one embodiment, the auto-injector includes a spiral spring configured to move the movable element. The spiral spring is energizable when assembled with the movable element. The spiral spring can be activated using a trigger, thereby converting its stored potential energy into kinetic energy, thereby driving the movable element. The movable element then forces fluid from the working reservoir. The total distance of movement can be determined depending on the configuration of the spiral spring relative to the stored energy. By predetermining the distance the movable element moves, the amount of fluid forced through the working reservoir and needle can be indirectly predetermined. If the fluid involves a drug, the dose of the drug can be adjusted, for example, by the size of the reservoir or the number of revolutions of the movable element relative to the spring design. These adjustments can be made during the device assembly process. Once the device is assembled, the dose delivered by the configuration is released.

[0012] In one embodiment, the auto-injector includes a reserve reservoir in fluid communication with the working reservoir and configured to replenish the working reservoir with fluid during a dosing operation, which maintains a larger amount of fluid available to be supplied to the outlet for the dosing operation.

[0013] The working reservoir advantageously has a smaller diameter than the reserve reservoir. As fluid is forced through the working reservoir, the fluid in the reserve reservoir directly replaces the volume of fluid displaced from the working reservoir. The larger volume of fluid and the larger diameter of the reserve reservoir create fluid pressure from the reserve reservoir to the working reservoir. As soon as fluid is displaced out of the working reservoir, a continuous flow of fluid from the reserve reservoir to the working reservoir can be established. This is important when administering medication, where a continuous flow of liquid is essential and, at the same time, a predetermined dose must be ensured.

[0014] In one embodiment, the reserve reservoir comprises a flexible primary pack, which may be a pouch. Employing a flexible primary pack has the advantage of improved robustness, particularly compared to glass syringes, which are fragile and prone to breakage. Furthermore, since the reservoir contains only one opening, on the injection side, that needs to be sealed, the integrity of the drug is improved and the risk of contamination is reduced. In auto-injectors with syringes, the stopper side must also be sealed.

[0015] Another advantage is that the reservoir can be adjusted to fit the device configuration, allowing for different configurations with maneuverability benefits. Its compactness and conformance avoids large PFS tolerances, reducing injection variability. Specifically, the reservoir can be made of plastic instead of glass, which can be manufactured with greater precision than glass. Furthermore, because no stopper is required, there is a lower risk of stalling and no stopper friction. The reservoir can be filled by vacuum filling, which eliminates any air, or by steam purging before closing the container. In the case of vacuum filling, the pouch can be pulled apart (e.g., by vacuum), which creates a vacuum within the pouch. This draws liquid from the connected container into the pouch.

[0016] In one embodiment, the reserve reservoir may be flexible, and in particular collapsible. A collapsible reservoir may have an inner cross-section that decreases as fluid is drained or removed from the reservoir. When the reservoir is emptied, the previously spaced apart inner surfaces that define the diameter of the reservoir may come into contact with one another.

[0017] In one embodiment, the working reservoir and the reserve reservoir are externally closeable apart from their fluid connection to the outlet of the auto-injector and their fluid interconnection to each other.

[0018] In one embodiment, the auto-injector includes circumferentially arranged elements surrounding the axis of rotation and positioned radially inwardly adjacent to the reserve reservoir, which ensures stable placement of the reserve reservoir and provides packaging efficiency.

[0019] In one embodiment, the movable element includes a squeeze unit having at least one squeeze element configured to squeeze the working reservoir, the squeeze unit being rotatable about an axis of rotation such that the at least one squeeze element rotates about the axis of rotation, thereby squeezing the working reservoir and forcing fluid within the working reservoir. Squeezing the working reservoir rather than the fluid itself is advantageous. In such a configuration, the fluid is moved by the indirect movement of the squeeze element toward the working reservoir. The fluid can be maintained in a closed loop and only released upon exiting the needle. Rotation of the squeeze element further has the advantage that squeezing the working reservoir, thereby causing fluid movement, is repeatable.

[0020] The squeezing element can include or be a roller. The squeezing element can be configured to rotate about the rotation axis while simultaneously rotating about a further rotation axis. The further rotation axis can extend through the squeezing element. The rotation axis can be external to the squeezing element. The further rotation axis can extend parallel to the rotation axis or can form an acute angle, e.g., less than 10°, with the rotation axis.

[0021] The squeezing unit may include a radially extending or radially oriented arm. The arm may have a first end closer to the axis of rotation and a second end located radially outward relative to the first end, i.e., further from the axis of rotation. The squeezing element may be located at one end of the arm, for example at the second end of the arm.

[0022] The pressing unit may comprise two or more, for example three, such arms. Each arm may be assigned to a pressing element. The arms may be arranged symmetrically around the axis of rotation.

[0023] The squeezing unit may be arranged such that when the squeezing element squeezes the working reservoir, the squeezing element presses against the working reservoir in a radially outward direction, in other words the working reservoir is radially compressed and / or axially stretched when squeezed.

[0024] In one embodiment, the working reservoir comprises a flexible material so that it can be effectively squeezed: rotation of the squeeze element about the axis of rotation ensures associated squeezing of the working reservoir.

[0025] A pumping device including a working reservoir with a squeezing element can include a peristaltic pump.

[0026] In one embodiment, the working reservoir is arranged circumferentially around the axis of rotation. In this way, a squeezing element rotatable about the axis of rotation can continuously squeeze the working reservoir, thereby causing a continuous flow of fluid through the needle. The working reservoir can be arranged circumferentially around the axis of rotation and include an arcuate cross-section. In such a configuration, the reserve reservoir can be arranged radially outward relative to the working reservoir. The reserve reservoir can also be arranged circumferentially around the axis of rotation. The reserve reservoir can also include an arcuate cross-section, with one end of the reserve reservoir in fluid communication with the working reservoir, whereby the larger, radially outer-located reserve reservoir is connected to the radially inner-mounted working reservoir including a smaller arcuate radius. The reserve reservoir and working reservoir comprise a spiral arrangement. The open end of the working reservoir is connected to the needle.

[0027] In one embodiment, the circumferentially arranged element is radially arranged between the working reservoir and the reserve reservoir. The circumferentially arranged element can be in mechanical contact with the working reservoir and / or the reserve reservoir. For example, the circumferentially arranged element mechanically supports the working reservoir while it is radially squeezed by at least one squeezing element.

[0028] During rotation of the squeezing element, the working reservoir is squeezed and thereby pushed radially outward. The circumferentially arranged element is arranged radially outward and is preferably adjacent to the working reservoir. The working reservoir pushed radially outward can be mechanically supported by the circumferentially arranged element. This not only ensures that a part of the working reservoir is moved outward, but also ensures that the force of the squeezing element towards the working reservoir is reliably transmitted to cause squeezing and, as a result, fluid to move through the working reservoir.

[0029] In one embodiment, the circumferentially arranged elements include cylindrical walls. The cylindrical shape provides a uniform surface in a direction around the axis of rotation. The cylindrical walls may have a cross section that is an arc of a circle.

[0030] In one embodiment, at least one squeezing element includes a roller configured to squeeze the working reservoir. The roller can be arranged at a radially outer end of the squeezing unit so as to be in direct contact with the working reservoir to squeeze it. The roller squeezes the working reservoir when the squeezing unit rotates about its rotation axis. The roller itself rotates about its own rotation axis, which is radially offset from the rotation axis of the squeezing unit and extends through the roller. The roller can rotate in a rotational direction opposite to that of the squeezing unit. While the roller is moved around the rotation axis of the squeezing unit together with the rotating squeezing unit, the rolling function of the roller reduces the resistance caused by friction between the roller and the working reservoir.

[0031] In one embodiment, the squeezing unit comprises at least two squeezing elements, preferably at angularly offset positions, configured to squeeze the working reservoir simultaneously, ensuring that continuous movement of fluid through the working reservoir is maintained.

[0032] In one embodiment, the compression unit includes three compression elements, which are arranged in a circular path around the rotation axis. The three compression elements can be arranged at equal intervals along the circle. Preferably, every two compression elements are spaced apart by an angle of 120°. The three intervals between the compression elements can also be 90°, 130°, and 70°. There can also be four or more compression elements.

[0033] In one embodiment, the spiral spring is mechanically coupled to the squeezing unit, providing rotational energy to drive the squeezing unit in a rotational direction. The spiral spring can be biased when assembled with the moving element. The spiral spring can be activated using a trigger, thereby converting its stored potential energy into kinetic energy, thereby driving the squeezing unit. The squeezing unit and squeezing element then force fluid from the working reservoir. The total distance of movement can be determined depending on the configuration of the spiral spring relative to the stored energy. By predetermining the distance the squeezing element moves, the amount of fluid forced through the working reservoir and needle can be indirectly determined. If the fluid is a drug, the dose of the drug can be adjusted, for example, by the number of revolutions of the moving element relative to the size of the reservoir or the design of the spring. These adjustments can be made during the device assembly process. The dose is set when the device is assembled.

[0034] In one embodiment, the automatic injector includes a rotary gear system mechanically coupled to the squeezing unit and configured to rotate the squeezing unit about an axis of rotation, the rotational speed of the squeezing unit being determined by a gear ratio of the rotary gear system. The gear ratio of the rotary gear system can be adjusted to reduce the force required to rotate the rotary gear system, which drives the squeezing unit, thereby compensating for resistance in the working reservoir and fluid. This is advantageous when the squeezing unit is rotated using an energy source with a limited amount of stored energy to drive the squeezing unit. Such an energy source can be a spiral spring, which is mechanically coupled to the rotary gear system and provides rotational energy to the rotary gear system.

[0035] In one embodiment, the rotary gear system may include a planetary gear system including a shaft that rotates about an axis of rotation.

[0036] In one embodiment, the movable element includes a diaphragm actuator incorporated in a diaphragm pump in fluid communication with the working reservoir, the diaphragm actuator configured to move axially, e.g., parallel to the axis of rotation, such that at least a portion of the fluid flows from the working reservoir through the diaphragm pump to the needle. The housing of the diaphragm pump can be stationary, while the corresponding diaphragm actuator and diaphragm are moving. According to the principle of the diaphragm pump, the movement of the diaphragm is inclined, preferably perpendicular to the direction of fluid movement within the pump housing. Thus, the diaphragm pump requires only a small space during operation.

[0037] In one embodiment, the circumferentially arranged element is rotatable about an axis of rotation and includes a mechanical guiding feature, and the diaphragm actuator is coupled to the mechanical guiding feature such that when the circumferentially arranged element rotates about the axis of rotation, the diaphragm actuator is moved parallel to the axis of rotation, thereby causing fluid to flow towards the needle.

[0038] The movement of the diaphragm actuator may be a variation of movement in one direction parallel to the axis of rotation followed by movement in an opposite direction parallel to the axis of rotation.

[0039] The use of a diaphragm pump is advantageous because no external load is applied to the working reservoir. Fluid flow occurs solely through the movement of the diaphragm actuator, which pushes and pulls the diaphragm, causing fluid movement through the working reservoir. Also, such an arrangement does not require a separate gearing system. Such a pumping device has lower torque requirements compared to peristaltic pumping devices, which increases pumping efficiency and facilitates smaller device size.

[0040] In one embodiment, the mechanical guiding function comprises a sinusoidal circumferential guiding function that ensures cyclic movement of the diaphragm actuator and / or the provision of a continuous flow of fluid through the working reservoir.

[0041] As the circumferentially arranged element rotates clockwise, the sinusoidal shape of the guiding feature can move the diaphragm actuator upward, following the wave. This draws fluid from the operating reservoir and fills the diaphragm. As the circumferentially arranged element continues to rotate, the sinusoidal shape at some point moves the diaphragm actuator downward, forcing the drug out of the pump. As the circumferentially arranged element continues to rotate, the diaphragm actuator moves upward again, refilling the pump. The two axial end faces of the guiding feature, facing in different directions along the axis, can guide the movement of the actuator during operation of the device. One axial end can guide movement upward, i.e., away from the fluid or housing, and the other can guide movement downward.

[0042] The circumferentially arranged element may include a cylindrical cam rotatable about an axis of rotation.

[0043] In one embodiment, the mechanical guiding features are arranged radially inside or outside the circumferentially arranged elements, which then support the integrated device since the diaphragm pump is also arranged radially inside the cylindrical cam.

[0044] In one embodiment, the mechanical guide feature comprises a groove or ridge. A groove has the advantage that a mechanical link with the diaphragm actuator can be established using a simple pin that engages the groove. A ridge has the advantage that the mechanical link needs to be secured from two sides of the ridge, which may be more stable than a single pin that enters the groove.

[0045] In one embodiment, the working reservoir and reserve reservoir are arranged in a common plane perpendicular to the axis of rotation, except for an end portion of the working reservoir near the outlet, if applicable, which end portion can be connected to a needle.

[0046] In one embodiment, the automatic injector includes an exit drive mechanism, the exit drive mechanism comprising: - Exit and an interface element coupled to or integral with the outlet, the interface element being movable from a first axial position to a second axial position along the axis of rotation; a trigger operably coupled to the interface element, the trigger being movable along the axis of rotation from a first trigger position to a second trigger position; and Including, in the first trigger position, the interface element is releasably locked against movement from the first axial position to the second axial position; in the second trigger position, the interface element is movable to a second axial position; Movement of the trigger from the first trigger position to the second trigger position releases the interface element from the first axial position and moves the interface element to the second axial position.

[0047] The outlet can include a needle. The interface element can include at least one interface feature. The interface element can include a needle holder. The interface feature can include a needle holder surface, the needle holder surface being disposed on the needle holder and oriented perpendicular to the rotation axis. Preferably, the needle holder includes a needle holder ledge, and the needle holder surface is disposed on the needle holder ledge. The needle holder can include two needle holder ledges, the needle holder ledges being disposed on opposite sides of the rotation axis, each including a needle holder surface. The needle holder can include a cylindrical body, the axis of which is the rotation axis. The two needle holder ledges are disposed radially outside the cylindrical body of the needle holder. The needle holder can include a mechanical guide, for example, an axial groove on the radial outside of the cylindrical body, to guide movement of the trigger along the rotation axis.

[0048] The 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 terminal ends of the trigger arms. The trigger interfaces may include an angled trigger surface.

[0049] When the trigger moves along the rotation axis, the trigger arm can be guided by a mechanical guide in the needle holder, which prevents the trigger arm from rotating. The trigger arm can also be prevented from rotating by a base element, which includes the mechanical guide and is fixed to or integrated with the housing of the device. 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 disposed on the rotation axis and configured so that the needle can move through the hole along the rotation axis. The hole can be sealed by a seal that seals the hole and the housing from the outside. The needle can penetrate the seal when moved toward the hole by the drive spring. The base element can include base element arms, which extend from the base element body toward the inside of the housing of the device. The base element arms are disposed around the rotation axis and spaced apart to have a gap. The spacing between the base element arms is configured to receive the radially outer member of the trigger arm for axially guiding the member in the assembled state, and the needle holder ledge is received in another spacing between the base element arms and is non-rotatable relative to the base element, and the base element is fixed to or integral with the housing, so that the needle holder ledge and needle holder are non-rotatable relative to the housing in the assembled state.

[0050] When the trigger is moved from the first trigger position to the second trigger position, the outlet drive mechanism enables release of the needle to move into position for injection. To prevent 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.

[0051] In one embodiment, the auto-injector includes a retention element, the retention element being in mechanical contact with the interface element; - the retaining element is rotatable about a rotation axis from a blocking position to a releasing position relative to the interface element; - in the blocking position, the interface element is releasably locked against movement from the first axial position to the second axial position by the retaining element; - in the released position, the interface element is movable from a first axial position to a second axial position; - Movement of the trigger from the first trigger position to the second trigger position causes the retaining element to rotate from the blocking position to the release position.

[0052] The retaining element can include at least one first retaining interface configured to interact with one of the trigger surfaces. The retaining element can include a collar. The collar can include one or more collar trigger arms, preferably two trigger arms, arranged opposite each other with respect to the rotation axis. The one or more collar trigger arms can include a first retaining interface. The first retaining interface can include a first retaining surface, which can be an inclined retaining surface, facing the trigger interface, which can be an inclined trigger surface along the rotation axis. 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 over each other. When the trigger is moved from the first trigger position to the 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 the surfaces slide over one another, axial movement of the trigger arm and inclined trigger surface exerts an axial force on the inclined retaining surface and collar trigger arm, causing the collar trigger arm and collar to rotate about an axis of rotation relative to the needle holder and needle holder ledge, which are prevented from rotating.

[0053] It is also possible that only one of the trigger surface and the retaining surface is inclined.

[0054] The retaining element further includes at least one second retaining interface, which is configured to interact with an interface element, specifically, with an interface feature that may be a surface of the needle holder ledge. The retaining element can include one or more collar retaining arms, preferably two retaining arms, which are arranged opposite each other with respect to the axis of rotation. Each collar retaining arm includes a second retaining interface, which may include a second retaining surface. Each second retaining surface faces an interface feature that may be a needle holder surface. In the first axial position of the needle holder, the needle holder surface is in mechanical contact with the second retaining surface such that the needle holder surface slides over the second retaining surface when the collar retaining arm rotates relative to the needle holder. The second retaining surface thereby blocks axial movement of the needle holder surface.

[0055] The one or more collar trigger arms and the one or more collar retaining arms are arranged alternately around the axis of rotation, with adjacent collar trigger arms and collar retaining arms separated by a spacing configured to receive the needle holder and / or trigger arm.

[0056] In the assembled state of the outlet drive mechanism, the collar is disposed inside the volume enclosed by the base element arms so as to be able to rotate within the base element.

[0057] When the trigger is moved from the first trigger position to the second trigger position, a force applied to the collar trigger arm causes the collar trigger arm to rotate relative to the needle holder and needle holder ledge until the needle holder ledge faces the collar space.

[0058] The needle holder ledge is blocked from axial movement by a collar retaining arm in the first axial position of the needle holder. In the release position of the retaining element, the drive spring moves the needle holder to the second axial position. The collar's blocked and released positions differ only in rotation / angle, not axial position.

[0059] The trigger interface is further configured to translate axial motion of the trigger and its interface into rotational motion of the retaining element. The trigger interface can include an arm extending along the axis of rotation for mechanical interaction with the collar.

[0060] The collar provides additional safety against accidental needle movement. The needle holder is released only when the collar undergoes a rotational movement, which is dependent on the axial movement of the trigger. The needle holder is blocked from rotation and cannot rotate on its own. Furthermore, in the blocking position of the collar, the surface of the collar retaining arm is pressed against the surface of the needle holder ledge by the compressed drive spring. This ensures that the collar cannot be rotated accidentally.

[0061] In one embodiment, the auto-injector includes an outlet drive unit operably coupled to the trigger and the interface element; - the outlet drive unit is configured to supply energy to move the interface element from a first axial position to a second axial position, the outlet drive unit having a first drive unit state and a second drive unit state; - in a first drive unit state, the outlet drive unit has stored energy, the interface element is in a first axial position, the retaining element is in a blocking position, and the interface element is prevented from moving to a second axial position; - in a second drive unit state, when the retaining element is in the released position, the outlet drive unit is capable of transmitting energy to the interface element such that the interface element is moved from the first axial position to the second axial position along the rotation axis; Movement of the trigger from the first trigger position to the second trigger position causes the outlet drive unit to change from a first drive unit state to a second drive unit state.

[0062] The outlet drive unit can include a drive spring. The drive spring can be disposed between the trigger and the needle holder along the rotation axis. 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 elongated and can transfer mechanical energy to the needle holder. Under the force of the elongated drive spring, the needle holder moves along the rotation axis to its second axial position.

[0063] When the release of the needle holder is initiated by the trigger, the needle holder is then moved by the drive spring to a second axial position, which can be a position for injection and administration. In this way, the trigger initiates the injection, which occurs automatically, and is driven by the drive spring when the trigger initiates the release of the needle holder.

[0064] In one embodiment, the trigger may also cause the dispensing of a fluid.

[0065] In one embodiment, the housing can have a shape with a general base that is greater in diameter than it is tall along the longitudinal axis, hi one embodiment, the shape comprises a cylinder, specifically a cylinder with rounded edges.

[0066] In one embodiment, the auto-injector is a disposable or single-use device for delivering a single dose.

[0067] Embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0068] [Figure 1A] 1A to 1F show schematic diagrams of a peristaltic pumping device.FIG. 1A shows a top view of a schematic peristaltic pumping device.FIG. [Figure 1B] 1 shows a perspective view of a peristaltic pump device. [Figure 1C] FIG. 1 shows a top perspective view of a peristaltic pump device with planetary gears. [Figure 1D] FIG. 1 shows a bottom perspective view of a peristaltic pump device with planetary gears. [Figure 1E] FIG. 1 shows a perspective view of a planetary gear with a spiral spring. [Figure 1F] 1 shows a cross-sectional view of a peristaltic pump device and needle drive mechanism. [Figure 2A] FIG. 1 shows a perspective view of a diaphragm pump device. [Figure 2B] 1 shows a cross-sectional view of a diaphragm pump device and a needle drive mechanism. [Figure 2C] 1 shows a perspective view of a diaphragm pump device having a spiral spring. [Figure 3A] 1A-1C show cutaway views of a diaphragm pump in different operating positions. [Figure 3B] 1A-1C show cutaway views of a diaphragm pump in different operating positions. [Figure 3C] 1A-1C show cutaway views of a diaphragm pump in different operating positions. [Figure 4A] An exploded view of the needle drive mechanism is shown. [Figure 4B] 1 shows a view of a needle drive mechanism having a drive spring in a first state and assembled with a base element; [Figure 4C] 1 shows a diagram of a needle drive mechanism with a drive spring in a first state. [Figure 4D] 10 shows a diagram of a needle drive mechanism with a drive spring in a second state. DETAILED DESCRIPTION OF THE INVENTION

[0069] Like reference numbers refer to like features throughout the figures and the following description.

[0070] FIG. 1A shows a top view of a first embodiment of the present disclosure. The figure illustrates a schematic peristaltic pump device 100. A compression unit 130 is rotatably disposed about a rotation axis Xro. The compression unit 130 includes three rollers 140. The compression unit 130 includes three arms that extend radially outward. Each roller 140 is disposed at the radially outer end of one arm of the compression unit 130 relative to the rotation axis Xro. The rollers 140 can rotate together with the compression unit 130 about the rotation axis Xro. During this rotation, the rollers also rotate about their own rotation axes in the opposite direction to the rotation axis Xro. The rollers 140 are evenly distributed circumferentially about the rotation axis Xro so that they are spaced apart at an angle of approximately 120°. The rollers 140 can also be spaced apart at various angles. In addition to the rotation of the compression unit 130 about the rotation axis Xro, the rollers 140 can rotate separately about their own rotation axes. The rollers 140 are configured to squeeze the tube 120 in a radially outward direction. The tube 120 contains a fluid material, such as a liquid drug or drug formulation. The tube 120 is positioned around the rotation axis Xro and radially spaced from the rotation axis Xro so that the rollers 140 can squeeze the tube 120. The tube 120 includes a cross section of an arc. One end of the tube 120 is in fluid communication with the needle 180. That end is not on the arc of the tube 120 but is positioned at a location along the rotation axis Xro that is away from the injection location. Furthermore, one section of the tube 120 is connected to the arc so that the squeezing unit 130 does not interfere with that section of the tube 120 during rotation.

[0071] Tube 120 is mechanically supported by cylindrical wall 125, which is positioned radially outwardly of tube 120 to prevent tube 120 from moving radially outward when rollers 140 squeeze it. As the three rollers 140 rotate, they press tube 120 against wall 125, which forces fluid through tube 120 and into needle 180. Tube 120 then expands and returns to its original shape, drawing in more drug from a flexible primary pack 110, such as pouch 110, which is in fluid communication with tube 120 through opening 135. Pouch 110 has a larger diameter than tube 120 and can accommodate a larger volume than tube 120. As soon as fluid is moved from tube 120 to needle 180, fluid from the collapsible pouch refills tube 120 with fluid, which ensures a continuous flow of fluid from tube 120 to needle 180.

[0072] FIG. 1B shows a perspective view of the schematic peristaltic pump device 100 shown in FIG. 1A. The figure shows an open-ended cylindrical wall 125 for mechanically supporting the tubing 120 as it is squeezed by the rollers 140. Also shown is a needle 180 coupled to a needle drive mechanism 300. The needle drive mechanism 300 is disposed inside the central gear 160 of the planetary gear 150 (not shown here) and is coupled to or integral with the housing 105. The needle drive mechanism 300 is mechanically decoupled from the central gear 160 so that the needle drive mechanism does not rotate when the central gear 160 rotates about the rotation axis Xro.

[0073] 1C shows a top perspective view of a peristaltic pumping apparatus including a planetary gear 150 for driving the compressing unit 130. The planetary gear has a central axis that is the rotation axis Xro. The planetary gear 150 includes a ring gear 155 that rotates about the rotation axis Xro. The planetary gear further includes three planetary gears 190 that are in rotational communication with the ring gear 155 and the central gear 160, which also rotate about the rotation axis Xro. The planetary gears 190 rotate about the central gear 160 and simultaneously rotate about their own rotation axes Xp1, Xp2, and Xp3. Each of the planetary gears 190 has the same diameter, which is larger than the diameter of the central gear 160 and smaller than the diameter of the ring gear 155. The ring gear 155, planetary gears 190, and central gear 160 are rotationally coupled to define a gear ratio that determines the force required to rotate the radially outermost ring gear 155 and the force required to rotate the central gear 160. The central gear 160 is mechanically coupled to the compression unit 130 so that movement of the central gear 160 moves the compression unit 130 in the same direction.

[0074] FIG. 1D shows a bottom perspective view of a peristaltic pumping device including a planetary gear 150 for driving a squeezing unit 130, viewed from a different angle compared to the view of FIG. 1C.

[0075] 1E shows a perspective view of planetary gears 150 with spiral springs 170, e.g., torsion springs. Planetary gears 150 are driven by spiral springs 170, which in turn drive ring gear 155. The rotation of ring gear 155 is then transferred to central gear 160 via planetary gears 190 at a predetermined gear ratio.

[0076] In one example, the dead volume within the tube 120 can be minimized by using a small diameter tube 120. The diameter of the tube 120 can be, for example, 0.5 mm to 1 mm, particularly 0.86 mm or 0.9 mm. In this example, the spiral spring 170 can only provide approximately 20 to 25 revolutions when fully energized, but the pump requires 120 revolutions to empty the primary pack. This necessitates the use of a gearing system to achieve the required pump revolutions. For this reason, a planetary gear with a gear ratio of 1:5 can be employed. This can be achieved by using an epicyclic gear.

[0077] In such a configuration, all fluid movement is by pulling or pushing through the working reservoir, thereby placing no load on the pouch 110. The pump device is also fundamentally suitable for patch pump applications.

[0078] Figure IF shows a cross section of peristaltic pump device 100 and needle drive mechanism 300, which includes needle 180. Needle drive mechanism 300 is shown in detail in Figures 4A-4D.

[0079] FIG. 2A illustrates a second embodiment of the present disclosure. The figure shows a perspective view of a diaphragm pump apparatus 200. The diaphragm pump apparatus 200 includes a diaphragm pump 230 having a diaphragm actuator 235 for actuating a diaphragm within the pump in a direction along an axis of rotation Xro. The diaphragm pump 230 is in fluid communication with a pipe 220 containing fluid such that, when the diaphragm actuator 235 is moved along the axis of rotation Xro, fluid is either pulled into or pushed out of the pump 230, depending on the direction the diaphragm actuator 235 is moving. Thus, the movement of the diaphragm actuator 235 is not along the axis of fluid movement, but is at an angle relative to that axis. The angle may be 90°, so that when the movement of the diaphragm actuator 235 is along the axis of rotation Xro, the fluid is moved perpendicular thereto. To effect fluid flow, the diaphragm actuator 235 must alternately move in one direction along the rotation axis Xro, followed by movement in the opposite direction along the rotation axis Xro. Movement in one direction allows fluid to flow into the diaphragm pump 230 from one side of the pipe 220, and subsequent movement in the opposite direction pushes fluid out of the diaphragm pump 230 on the other side, with the diaphragm pump 230 positioned between the two sides. The pipe 220 is in fluid communication with the needle 180. Fluid transported through the pipe 220 is moved through the needle 180 for dispensing. In this configuration, the diaphragm pump 230 is stationary, while the diaphragm actuator 235 within the diaphragm pump 230 moves along the rotation axis Xro. The movement of the diaphragm actuator 235 is driven by a cylindrical cam 240 that rotates about the rotation axis Xro. The cylindrical cam 240 includes a sinusoidal groove 250 on its radially inner side. Diaphragm actuator 235 is mechanically coupled to groove 250. As cylindrical cam 240 rotates, diaphragm actuator 235's motion follows the shape of groove 250, the motion of which is shown in detail in Figures 3A-3C.The amplitude of the sinusoidal shape is transferred to the diaphragm actuator 235 by a mechanism of the diaphragm actuator 235 that is mechanically coupled to and follows the shape of the groove 250. The diaphragm actuator 235 is thereby forced to undergo a periodic oscillation, which ensures a continuous flow of fluid through the pipe 220 and needle 180. The mechanism further includes a flexible primary pack, which may be pouch 110. The pouch 110 is in fluid communication with the pipe 220 and ensures that there is a continuous fluid in the pipe 220 that can move to the needle 180.

[0080] The diaphragm pump device further includes a spiral spring 170 (not shown), which is mechanically coupled to the cylindrical cam 240. The rotation of the cylindrical cam 240 is driven by the spiral spring 170. When the spiral spring 170 is energized, it has a certain amount of potential energy. This energy is sufficient for the cylindrical cam 240 to rotate a certain number of times around the rotation axis Xro. The number of rotations is related to the rate of movement of the diaphragm actuator 235, which in turn is related to the amount of fluid moved through the pipe 220 and ultimately through the needle 180. Therefore, the amount of fluid moved through the needle 180 can be preset by setting the energy of the spiral spring 170. If the fluid contains a drug, the drug dose can be set by setting the energy of the spiral spring 170.

[0081] To minimize dead volume and maximize dose accuracy, a low-volume, high-frequency pump is preferred. This can be achieved using a pump whose single-stroke volume is at least 1 / 50th of the total volume delivered by the device. Testing has shown this to require more than 20 strokes (the spiral spring provides 20 revolutions). By using a cylindrical cam with a sinusoidal wave profile, 420 pump strokes can be achieved without the need for additional gearing.

[0082] The mechanism further includes a needle drive mechanism 300 having a drive spring 310. Needle drive mechanism 300 is shown in detail in Figures 4A-4D.

[0083] Figure 2B shows a cross section of the diaphragm pump device 200 and a needle drive mechanism 300 having a drive spring 310. The needle 180 is disposed in the needle drive mechanism 300. The needle drive mechanism 300 is mechanically coupled to the spiral spring 170 such that when the needle 180 fills with fluid during a pumping stroke, a trigger (310) moves the needle along the axis of rotation Xro into the patient's tissue, followed by injection of a medication when the needle reaches a predetermined depth in the patient's tissue. This is explained in more detail in Figures 4A-4D.

[0084] FIG. 2C shows a perspective view of a diaphragm pumping device 200 having a spiral spring 170.

[0085] 3A-3C show cutaway views of the diaphragm pump in different operating positions. To illustrate this, markers 260 are shown radially inward of cylindrical cam 240 to indicate the movement of diaphragm actuator 235 caused by and relative to cylindrical cam 240. In this example, cylindrical cam 240 moves clockwise.

[0086] 3A, the actuator 235 is moved to the positive peak of the sinusoidal wave amplitude, and the marker 260 is positioned in a counterclockwise direction. The upward movement of the diaphragm actuator 235 to the positive peak of the sinusoidal wave causes fluid to be drawn from the operating reservoir 220 into the diaphragm pump 230.

[0087] In Figure 3B, cylindrical cam 240 has further rotated clockwise, causing the sinusoidal wave to move diaphragm actuator 235 downward to the negative peak of the sinusoidal wave, thereby pushing fluid through working reservoir 220 toward needle 180. As shown in Figure 3B, diaphragm actuator 235 has reached the position of marker 260.

[0088] 3C, the movement of diaphragm actuator 235 repeats that described in FIG. 3A. As cylindrical cam 240 continues to rotate, the sinusoidal wave causes diaphragm actuator 235 to move further counterclockwise, away from marker 260. Diaphragm actuator 235 reaches the next positive peak of the sinusoidal wave, drawing more fluid from operating reservoir 220 into diaphragm pump 230.

[0089] This mechanism ensures cyclical movement of the diaphragm actuator 235 resulting in a continuous flow of fluid through the working reservoir 220 to the needle 180 .

[0090] The mechanism works on the same principle when the cylindrical cam 240 moves counterclockwise.

[0091] The device can have a height of 10 to 40 mm, particularly 15 to 30 mm. The base of the device can have a diameter of 45 to 90 mm, particularly 50 to 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 where the device is triggered is much smaller.

[0092] Figure 4A shows an exploded view of needle drive mechanism 300. Both the first embodiment according to Figures 1A-1F for a peristaltic pump and the second embodiment according to Figures 2A-3C for a diaphragm pump can include needle drive mechanism 300 according to Figures 4A-4D unless otherwise specified.

[0093] 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 coupled to the needle holder 340.

[0094] 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 has a cylindrical shape, with a height or thickness smaller than its diameter, forming an overall disk-like shape. The trigger button body 325 may also have any other shape, such as a rectangular or square thin plate. The trigger button body 325 may be coupled to or integral with the device housing 105 and may have the same thickness as the housing 105. The two trigger button arms 330 are disposed on opposite sides of 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 its end away from the trigger body 325 relative to the rotation axis Xro. The inclined surface is disposed on the radially inner member.

[0095] The drive spring 310 is disposed between the trigger button body 325 and the needle holder 340 along the rotation axis Xro, and is extensible and compressible along the rotation axis Xro. The collar 360 can be disposed inside the base element 400. When the drive spring 310 is compressed, the needle holder 340 is disposed between the collar 360 and the drive spring 310.

[0096] The needle holder 340 includes a cylindrical body and two needle holder ledges 350 that extend radially outward from the body and are disposed on opposite sides of the rotation axis Xro. The needle holder 340 is operatively coupled to the drive spring 310 such that when the drive spring 310 extends along the rotation axis Xro, the needle holder 340 and needle 180 move along the rotation axis Xro away from the trigger button body 325. The needle holder ledges 350 may have a wedge shape, with their cross sections narrowing radially inward.

[0097] The collar 360 includes a collar base 365, two collar retention arms 380, and two collar trigger arms 390. The two collar retention 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 retention arms 380 are disposed on opposite sides of the rotation axis Xro. The two collar trigger arms 390 are disposed on opposite sides of the rotation axis Xro. The collar retention arms 380 and the collar trigger arms 390 are alternately disposed around the rotation axis Xro and are spaced apart by a collar spacing 370. The collar retention arms 380 include a rectangular shape. The collar trigger arms 390 also include a rectangular base shape, but have a sloped surface at their end that faces away from the collar base 365 and faces the sloped surface of the radially inner member of the trigger button arm 330. Either the trigger button arm 330 or the collar trigger arm 390 may include a sloped surface. For example, if only the trigger button arm 330 includes a ramped surface, that ramped surface will press against the edge of the collar trigger arm, thereby causing further movement along the rotational axis Xro, which will also rotate the collar 360. The collar base 365 includes a hole so that the needle 180 can pass through the hole and move along the rotational axis Xro.

[0098] The base element 400 includes a base element body 405 and four base element arms 410, each extending from the base element body 405 along a rotation axis Xro 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 disk-like shape. The base element body 405 may also include any other shape, such as a rectangular or square thin plate. The base element body 405 may be coupled to or integral with the device housing 105. The base element arms 410 extend from the base element body 405 along and are disposed about 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 separated from one another by a spacing 420. Two of the gaps 420 are configured to receive the radially outer member of the trigger button arm 330, such that the trigger button arm 330 is axially guided within the gaps 420 but cannot rotate. The other two gaps are configured to receive the needle holder 350 along the rotation axis Xro, whereby the needle holder 350 cannot rotate. The base element body 405 includes a hole so that the needle 180 can pass through the hole and move along the rotation axis Xro to the outside of the device for injection. The hole can be sealed with a seal that can be penetrated by a needle.

[0099] 4B shows a diagram of the needle drive mechanism 300 in an assembled state. The drive spring 310 is compressed between the trigger button 320 and the needle holder 340 relative to the rotation axis Xro such that the drive spring 310 biases the needle holder 340. The trigger button arm 330 is partially within the base element space 420 so as to be movable along the rotation axis Xro and is guided by the base element arm 410 that forms the base element space 420. The trigger button arm 330 is prevented from rotating by the base element arm 410 when it is axially movable within the base element space.

[0100] Alternatively, the trigger button arm 330 can be made non-rotatable by the needle holder 340. The cylindrical body of the needle holder 340 can include an additional groove, which is oriented along the rotation axis Xro and configured to mechanically guide the trigger button arm 330 along the rotation axis Xro, thereby making the arm 330 non-rotatable.

[0101] The needle holder ledge 350 is similarly arranged in the base element space 420. In this manner, the needle holder ledge 350 is prevented from rotating by the base element 400, and when the base element 400 is part of the housing 105 of the device, the needle holder ledge 350 and the needle holder 340 are prevented from rotating by the housing 105. Furthermore, the needle holder ledge 350 is axially blocked by the collar 360. The collar 360 is arranged in the space enclosed by the base element arms 410.

[0102] The needle holder 340 includes a hole for receiving a pipe (not shown). The hole may be directed radially inward from the needle holder ledge 350. The pipe is in fluid communication with the needle 180 and either the tubing 120 according to the embodiment of FIGS. 1A-1F or the tubing 220 according to the embodiment of FIG. 2A. In this manner, fluid in the pouch 110 can be transferred to the needle 180 for administration. In the embodiment of the peristaltic pump according to FIGS. 1A-1F, a portion of the pipe is disposed between the base element 400 and the central gear 160 and is connected to the tubing 120 at the central gear 160, so that one of the ends of the pipe can be connected to the tubing 120 to establish fluid communication. This mechanism ensures that the pipe is decoupled from the rotational movement of the central gear 160.

[0103] FIG. 4C shows a view of 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 relative to the rotation axis Xro, such that the drive spring 310 biases the needle holder 340. The needle holder 340 is disposed between the drive spring 310 and the collar 360, relative to the rotation axis Xro. The needle holder ledge 350 is in mechanical contact with the terminal 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 disposed radially outward relative to the drive spring 310 and the needle holder 340. The terminal end of the trigger button arm 330 faces the terminal end of the collar trigger arm 390, but is spaced axially apart. The terminal end of the trigger button arm 330 and the terminal end of the collar trigger arm 390 both include an inclined surface, so that when the inclined surface of the trigger button arm 330 is pressed against the surface of the collar trigger arm 390, the surfaces slide toward each other, and 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 collar 360 to rotate.

[0104] 4D shows a view of the assembled needle drive mechanism 300 without the base element. In the figure, the drive spring 310 is extended along the rotation axis Xro. The needle holder 340 is moved along the rotation axis Xro away from the trigger button body 325 by the force of the extending drive spring 310. The needle holder ledge 350 is thereby engaged with the collar spacer 370, thereby guiding the movement of the needle holder 340 along the rotation axis Xro.

[0105] 4B or 4C , i.e., when the drive spring 310 is compressed and movement of the needle holder 340 away from the trigger button body 325 is blocked, pressing the trigger button 320 along the rotation axis Xro toward the drive spring 310 moves the trigger button arm 330 toward the collar trigger arm 390. When the inclined surface of the trigger button arm 330 is pressed toward the surface of the collar trigger arm 390, the axial movement of the trigger button arm 330 causes rotational movement of the collar trigger arm 390 and the collar 360. 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 disengages from the collar trigger arm 390. The needle holder 340 then 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 for the collar retaining arm 380 to be the same length as the collar trigger arm 390. In that case, the trigger button arm 330 would need to have its length adjusted. The needle holder ledge 350 then engages the collar gap 370, and the needle holder 340, together with the needle 180, moves away from the trigger button body 325, towards the base element 400, and toward the injection site under the force of the expanding drive spring 310.

[0106] The scope of protection is not limited to the examples given herein above. Every invention disclosed herein is embodied in each and every novel feature and each combination of features, and they include in particular any combination of any features set out in the claims, even if that feature or combination of features is not explicitly set out in the claims or examples.

[0107] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease or otherwise improve physical or mental well-being. Drugs or medications can be used for a limited duration or periodically for chronic disorders.

[0108] As described below, drugs or pharmaceutical agents 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 with a molecular weight of 500 Da or less, polypeptides, peptides, and proteins (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, such as 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 contemplated.

[0109] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can occur at room temperature (e.g., about 20°C) or refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components prior to and / or during administration to the 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 to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0110] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent 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 embolism. Further examples of disorders include acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as Rote Liste 2014 (e.g., but not limited to, Main Group 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0111] 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 a human insulin analog or derivative; glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof; a dipeptidyl peptidase-4 (DPP4) inhibitor; or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residue can be either a codable amino acid residue, another naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, for example, the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable ones, are added to the naturally occurring peptide.

[0112] Examples of insulin analogues are 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 the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0113] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); 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; B30-N-myristoyl-ThrB29LysB30 human insulin. 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®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0114] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin -4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C, CM-3, GLP-1 Erigen, ORMD-0901, NN-9924, NN-9926, NN-9927, nodexene, Viadol-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.

[0115] An example of an oligonucleotide is, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia.

[0116] Examples of DPP4 inhibitors are vidagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0117] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0118] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low-molecular-weight heparin or ultra-low-molecular-weight heparin or derivatives thereof, 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 include Hylan G-F20 (Synvisc®) and sodium hyaluronate.

[0119] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, antibody fragment, or mutant that does not support Fc receptor binding, e.g., has a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins (CODVs) with a crossover binding region orientation.

[0120] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, e.g., bivalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular 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.

[0121] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and that are primarily responsible for maintaining the proper orientation of the CDR sequences to enable antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDRs to interact with the antigen.

[0122] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0123] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use as drugs or medicaments in drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0124] Those skilled in the art will understand that modifications (additions and / or omissions) can be made to the various components, formulations, devices, methods, systems and embodiments of the API described herein without departing from the overall scope and spirit of the invention, and that the invention encompasses such modifications and all equivalents thereof.

[0125] This patent application claims priority from European Patent Application No. 20315494.3, the disclosure of which is incorporated herein by reference. [Explanation of symbols]

[0126] 100 Peristaltic pump device 105 Housing 110 Flexible Primary Pack 120 tubes 125 Cylindrical Wall 130 Compression Unit 135 Opening 140 Laura 150 Planetary Gear 155 Ring Gear 160 Central Gear 170 Spiral spring 180 needles 190 Planetary Gear Xro rotation axis Xp1, Xp2, Xp3 Planetary gear rotation axis 200 Diaphragm pump device 220 Pipe 230 Diaphragm Pump 235 Diaphragm Actuator 240 cylindrical cam 250 groove 260 Marker 300 Needle drive mechanism 310 Drive spring 320 Trigger Button 325 Trigger button body 330 Trigger Button Arm 340 Needle Holder 350 Needle Holder Ledge 360 Color 365 Color Base 370 color spacing 380 Collar Holding Arm 390 Color Trigger Arm 400 base elements 405 Base Element Body 410 Base element arm 420 base element spacing

Claims

1. 1. An auto-injector comprising: a housing (105) configured to receive a working reservoir (120, 220) having a fluid; a pump device (100, 200) configured to force fluid from an operating reservoir (120, 220) toward and through an outlet (180) of the automatic injector during a dispensing operation; The automatic injector comprising:

2. 2. The automatic injector of claim 1, wherein the pump device (100, 200) includes a movable element (130, 230) operatively coupled to the operating reservoir (120, 220) such that movement of the movable element (130, 230) forces at least a portion of the fluid from the operating reservoir (120, 220) to the outlet (180).

3. a reserve reservoir (110) in fluid communication with the working reservoir (120, 220) and configured to replenish the working reservoir (120, 220) with fluid during a dosing operation; and / or 3. The automatic injector according to claim 1 or 2, comprising circumferentially arranged elements (125, 240) surrounding the axis of rotation (Xro) and arranged radially inside and adjacent to the reserve reservoir (110).

4. The automatic injector of any one of claims 1 to 3, comprising a spiral spring (170) configured to move the movable element (130, 230).

5. The moving element (130, 230) comprises a pressing unit (130), which at least one squeeze element (140) configured to squeeze the working reservoir (120); 5. The automatic injector according to claim 2, wherein the squeezing unit (130) is rotatable about an axis of rotation (Xro) such that at least one squeezing element (140) rotates about the axis of rotation (Xro) and thereby squeezes the working reservoir (120) and forces fluid in the working reservoir (120).

6. and / or the circumferentially arranged element (125) is arranged radially between the working reservoir (120) and the reserve reservoir (110) so as to mechanically support the working reservoir (120) while the working reservoir (120) is radially squeezed by the at least one squeeze element (140); 6. The automatic injector of claim 5, further comprising a rotary gear system (150) mechanically coupled to the squeezing unit (130) and configured to rotate the squeezing unit (130) about a rotation axis (Xro), the rotation speed of the squeezing unit (130) being determined by a gear ratio of the rotary gear system (150).

7. 7. The automatic injector of claim 6, wherein the spiral spring (170) is mechanically coupled to the rotary gear system (150) and provides rotational energy to the rotary gear system (150).

8. 5. The automatic injector of claim 2, wherein the movable element (230) comprises a diaphragm actuator (235) incorporated in a diaphragm pump (200) in fluid communication with the working reservoir (220), the diaphragm actuator (235) configured to move parallel to the axis of rotation (Xro) such that at least a portion of the fluid flows from the working reservoir (200) through the diaphragm pump (230) to the outlet (180).

9. 9. The automatic injector according to claim 8, wherein the circumferentially arranged element (240) is rotatable about a rotation axis (Xro) and comprises a mechanical guiding feature (250), and the diaphragm actuator (235) is coupled to the mechanical guiding feature (250) such that when the circumferentially arranged element (240) rotates about the rotation axis (Xro), the diaphragm actuator (235) is moved parallel to the rotation axis (Xro), thereby causing the fluid to flow towards the needle (180).

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, the outlet drive unit (310) having a first drive unit state and a second drive unit state; 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 is a disposable or single-use device for delivering a single dose; and / or The automatic injector includes a reserve reservoir (110) in fluid communication with the working reservoir (120, 220) and configured to replenish the working reservoir (120, 220) with fluid during a dosing operation; The automatic injector includes circumferentially arranged elements (125, 240) surrounding a rotation axis (Xro) and arranged radially inside and adjacent to a reserve reservoir (110); The automatic injector according to any one of claims 1 to 12, wherein a circumferentially arranged element (125) is arranged radially between the working reservoir (120) and the reserve reservoir (110) and mechanically supports the working reservoir (120).

14. The squeezing unit (130) includes radially oriented arms, The squeezing element (140) is a roller located at one end of an arm; the squeezing element (140) is configured to rotate about the rotation axis while simultaneously rotating about a further rotation axis, the further rotation axis being parallel to the rotation axis; The automatic injector according to claim 5 or any one of claims 6 to 13 dependent on claim 5, wherein the squeezing unit (130) is arranged such that when the squeezing element (140) squeezes the working reservoir (120), the squeezing element (140) presses the working reservoir (120) in a radially outward direction.

15. The automatic injector of any one of claims 1 to 14, further comprising a working reservoir (120, 220) containing a fluid, the fluid being a liquid medicament.

Images