Injection device for injecting a pharmaceutical substance, and method for controlling an injection device

Abstract

The invention relates to an injection device (1) for injecting a pharmaceutical substance, comprising: an injection main part (3), which has a primary packaging means holder (19) and a pressure generating device (21) with a pressure line (23), wherein the primary packaging means holder (19) is designed and configured to receive a primary packaging means (25), the pressure line (23) is positioned and designed so as to connect the pressure generating device (21) to the primary packaging means (25) so as to conduct pressure, and the pressure-generating device (21) is designed to apply a discharge pressure to a displaceable stopper (29) of the primary packaging means (25), the stopper delimiting a packaging means volume of the primary packaging means (25), via the pressure line (23) by means of a pressure medium when the primary packaging means (25) is received in the primary packaging means holder (19). The invention also relates to a method for controlling such an injection device (1) for injecting a pharmaceutical substance from a primary packaging means (25).

Description

[0001] 2024-01

[0002] 1

[0003] Vetter Pharma-Fertigung GmbH & Co. KG

[0004] DESCRIPTION

[0005] Injection device for injecting a pharmaceutical substance and control method for an injection device

[0006] The invention relates to an injection device for injecting a pharmaceutical substance and a control method for an injection device for injecting a pharmaceutical substance.

[0007] Such injection devices can have various designs, for example, as syringes, injection pens, autoinjectors, and electromechanical injection devices. With an autoinjector, the skin puncture and injection of the pharmaceutical substance are carried out using a spring-based mechanism, which is why autoinjectors can be manufactured relatively inexpensively. The autoinjector has a pre-tensioned and locked spring, which is released during an injection. The spring expands, thereby puncturing the skin and injecting the pharmaceutical substance. Upon release, the spring usually expands abruptly and strikes a stopper in the primary packaging, resulting in a perceptible injection pulse under the skin, which is unpleasant for the patient.Furthermore, autoinjectors are typically designed for single use and are disposed of after a single injection. Alternatively, electromechanical injection devices have become established. In these devices, an electric drive moves a piston rod, which displaces a plug in the primary packaging, thereby injecting the pharmaceutical substance. Because the piston rod's movement speed can be adjusted via the electric drive, such an injection produces a much smaller, or even no, injection pulse. With an electromechanical injection device, the piston rod is not inserted into the primary packaging when not in use. Consequently, the housing of an electromechanical injection device is comparatively large, as space must be provided within the housing for the extended piston rod.While a multiple injections can be performed with such an electromechanical injection device.

[0008] 212220 PCT - KO-HF 2024-01

[0009] 2, however, this one has significantly more components than an autoinjector and is therefore comparatively expensive to manufacture.

[0010] The invention is therefore based on the objective of creating an injection device for injecting a pharmaceutical substance and a control method for an injection device for injecting a pharmaceutical substance, wherein the aforementioned disadvantages are at least reduced, preferably avoided.

[0011] The problem is solved by providing the present technical teaching, in particular the teaching of the independent claims as well as the embodiments disclosed in the dependent claims and the description.

[0012] The problem is solved, in particular, by providing an injection device for injecting a pharmaceutical substance. The injection device comprises an injection body that includes a primary packaging receptacle and a pressure generation device with a pressure line. The primary packaging receptacle is designed and configured to receive, and in particular to hold, a primary packaging material, in particular an interchangeable one, and in particular such that the primary packaging material can be arranged, and in particular inserted, in the primary packaging receptacle in an interchangeable manner. The pressure line is arranged and configured to connect the pressure generation device to the primary packaging material in a pressure-conducting manner, in particular when the primary packaging material is received, and in particular held, arranged, and in particular inserted, in the primary packaging receptacle.The pressure generation device is configured to apply a pressure, in particular a time-dependent pressure profile, to a movable plug of the primary packaging, which limits the packaging volume of the primary packaging, via the pressure line using a pressure medium, when the primary packaging is received in the primary packaging receptacle, in particular so that the movable plug is displaced along a central axis of the primary packaging in such a way that the packaging volume is reduced, so that the pharmaceutical substance is dispensed, in particular injected, from the primary packaging by means of an injection end.

[0013] 212220 PCT - KO-HF 2024-01

[0014] 3

[0015] The injection device advantageously enables a more comfortable injection of the pharmaceutical substance for the patient than with an autoinjector. The delivery pressure does not act abruptly on the stopper, but rather builds up gradually from a lower pressure, particularly ambient pressure, over a predetermined period. This results in a smooth, and especially non-jerky, displacement of the stopper, advantageously reducing, and preferably eliminating, the injection impulse that occurs with autoinjectors and is felt under the skin. A large number of injections can be performed with the injection device, as only the primary packaging needs to be replaced. The injection device is therefore reusable—apart from the primary packaging—which leads to a significant reduction in waste compared to an autoinjector.Since the repositioning of the stopper is achieved by means of the pressure medium, the injection device advantageously does not have a piston rod. In particular, the repositioning of the stopper occurs directly, especially without intermediate mechanical elements, by means of the pressure medium. Specifically, the pressure medium acts directly, especially on the reverse side of the stopper opposite the pharmaceutical substance. Thus, it is not necessary to provide space in the injection device for the extended piston rod, which is why the injection device is more compact than an electromechanical injection device with a piston rod.Since the pressure generating device is connected to the primary packaging material via a pressure line that can be freely routed within certain limits in the injection device, it is not necessary for the pressure generating device to be arranged along a displacement axis of the plug behind the primary packaging material. Instead, it is possible for the pressure generating device to be arranged transversely to the displacement axis next to the primary packaging material. The injection device is not rod-shaped, like an autoinjector or an electromechanical injection device, but rather cuboid-shaped, which facilitates a user's secure grip and hold of the injection device before and during injection. In particular, the injection device is designed as a manageable handheld device that can preferably be gripped and used with one hand.In particular, the injection device is designed to be pocket-sized.

[0016] In one embodiment, the injection device has an on / off switch which is configured to selectively turn the injection device on and off.

[0017] 212220 PCT - KO-HF 2024-01

[0018] 4

[0019] In one embodiment, the injection body has a distal end and a proximal end opposite the distal end, the distal end facing, in particular, a skin surface into which the pharmaceutical substance is injected, while the proximal end faces away from the skin surface. In another embodiment, the injection body is designed as a housing for the injection device, in which the primary packaging receptacle, the pressure generation device, and the pressure line are arranged. The housing is particularly box-shaped, especially cuboid. Advantageously, this makes the injection device particularly compact. The injection device can thus be transported, in particular, in a trouser pocket. The housing, in particular, has recessed gripping sections for gripping by a user.In particular, the gripping sections comprise a friction-enhancing material, especially a plastic, particularly a rubber, and optionally a friction-enhancing surface structure, particularly a structured surface. In one embodiment, the distal end comprises several irritation elements designed to irritate the skin surface of a patient. In particular, the irritation elements are designed as pointed elements that project transversely, in particular orthogonally, from the distal end, in particular from a distal surface that comes into contact with the skin surface of a patient during injection. In particular, the irritation elements comprise a plastic, in particular a hard plastic, in particular a rubber, in particular a hard rubber, or are formed from a plastic, in particular a hard plastic, in particular a rubber, in particular a hard rubber.Advantageously, when the injection device is placed on the skin surface with its distal surface, the irritation elements irritate the skin surface in such a way that a patient no longer fully perceives the puncturing of the skin surface and, in particular, cannot clearly feel the location of the puncture.

[0020] In one embodiment, the injection device, in particular the injection base body, has a status indicator device. In one embodiment, the status indicator device has at least one light-emitting diode (LED) which is designed and configured to indicate at least one state of the injection device. In particular, the state is selected from a group consisting of: a charge state of an energy storage device of the injection device, a current position selected from a connected position and a disconnected position, a 212220 PCT - KO-HF 2024-01

[0021] 5

[0022] The status indicator device displays the pressure medium interface, in particular whether the pressure line is pressure-conducting and connected to the primary packaging material, and the injection progress, in particular whether the injection is complete, and in particular whether the pharmaceutical substance has been fully injected. In one embodiment, the status indicator device has an annular LED, which is arranged, in particular, at the proximal end. In particular, the annular LED is configured to emit light in different colors. Advantageously, at least one state, and in particular several states, of the injection device can be indicated by means of the different colors. In another embodiment, the status indicator device alternatively or additionally has three LEDs, wherein a first LED of the three LEDs indicates the charge state of the energy storage device, a second LED of the three LEDs indicates the current position of the pressure medium interface, and a third LED of the three LEDs indicates the injection progress.In particular, each of the three LEDs has a shape corresponding to the state it indicates, allowing a user to intuitively recognize which state each LED is meant to display. Specifically, the shape is selected from a group consisting of a battery shape, a hook shape, and a teardrop shape. Alternatively or additionally, the status indicator device features a progress bar that displays the injection progress. Specifically, the progress bar has multiple LEDs. Specifically, the ring-shaped LED is configured to display the injection progress, particularly as a ring-shaped progress bar.

[0023] In one embodiment, the primary packaging receptacle has at least one retaining element, in particular two retaining elements, which is designed and arranged to securely hold the primary packaging. In particular, the retaining element has a groove into which a retaining section of the primary packaging engages. In particular, the primary packaging receptacle has a stop element which is designed and arranged to interact with a counter-stop element of the primary packaging to hold the primary packaging in a predetermined position. In particular, the retaining element is designed as the stop element. In particular, the primary packaging receptacle has two, in particular three, in particular four stop elements as the stop element, wherein the primary packaging also has two, in particular three, in particular four counter-stop elements as the counter-stop element.In particular, the primary packaging receptacle has a packaging locking device which is arranged and set up 212220 PCT - KO-HF 2024-01.

[0024] 6 is to selectively release and lock the primary packaging material, in particular to selectively release and lock the insertion of the primary packaging material into the primary packaging material receptacle and the removal of the primary packaging material from the primary packaging material receptacle. In particular, the injection device has a release / lock switch which is operatively connected to the packaging material locking device in order to switch the packaging material locking device between a locked switching state and a release switching state.

[0025] In one embodiment, the pressure generating device is configured to generate a pressure different from ambient pressure, in particular a standard atmospheric pressure of 1013.25 hPa, and in particular a pressure greater than the standard atmospheric pressure. Specifically, the pressure generating device is configured to generate a pressure different from ambient pressure of up to 1 MPa, in particular at least 0.1 MPa, in particular at least 0.2 MPa, in particular at least 0.4 MPa, in particular at least 0.6 MPa, in particular at least 0.7 MPa, and in particular at least 0.9 MPa. This makes it possible, in particular, to inject pharmaceutical substances with a dynamic viscosity r) of up to 150 mPa s, in particular up to 145 mPa s. Specifically, the pressure generating device is configured to generate the dispensing pressure, in particular the dispensing pressure profile over time. In particular, the pressure generating device draws the pressure medium from the surrounding environment.In particular, the pressure generating device compresses the pressure medium and introduces it into the pressure line.

[0026] In one embodiment, the pressure line is flexible, in particular bendable down to a minimum bending radius. Specifically, the pressure line is connected at a first end to a pressure outlet of the pressure generating device. In particular, the pressure line is attached to at least one fastening element of the injection base body.

[0027] In one embodiment, the primary packaging comprises a packaging base body, a stopper that is movable, particularly along the central axis, and the injection end. Specifically, the packaging base body, together with the movable stopper, defines the packaging volume in which the pharmaceutical substance is contained, and in particular stored. The primary packaging also has a [missing information - likely a specific feature or feature] adjacent to the rear of the stopper and opposite the pharmaceutical substance with respect to the stopper.

[0028] 212220 PCT - KO-HF 2024-01

[0029] 7

[0030] A pressure chamber is created into which the pressure medium flows during injection, subjecting the plug to the dispensing pressure. In particular, the pressure chamber is sectionally delimited by the packaging body and the plug. Specifically, the plug is displaceable, particularly along its central axis, relative to the packaging body, such that the pharmaceutical substance is dispensed from the packaging volume via the injection end when the displaceable plug is moved along its central axis in such a way that the packaging volume decreases. In one embodiment, the injection end has a puncturing element or is designed as a puncturing element. In particular, the puncturing element is a needle. Specifically, the needle is detachably connected to the packaging body at its distal end, particularly by means of a so-called Luer connection system.Alternatively, the needle is preferably fixedly connected to the packaging base body, which is also referred to as a staked needle configuration. In particular, when the primary packaging is received in the primary packaging receptacle, the puncturing element points towards the distal end or projects from the distal end during injection. In one embodiment, the packaging base body has a retaining section, in particular several retaining sections. In another embodiment, the primary packaging has a packaging frame, preferably made of plastic, in which the packaging base body is mounted. In particular, the packaging frame has a retaining section, in particular several retaining sections. In particular, the packaging frame has an injection end shield device that is arranged and configured to cover, in particular shield, the injection end after the pharmaceutical substance has been injected.This allows for the safe removal of the empty primary packaging.

[0031] In one embodiment, the primary packaging is designed as a glass body sealed by a stopper, with the injection end, particularly the puncture element, being arranged opposite the stopper. In another embodiment, the primary packaging is designed as a plastic body sealed by a stopper, with the injection end, particularly the puncture element, being arranged opposite the stopper. In particular, the primary packaging is a prefilled syringe, also referred to as a Prefilled Syringe System (PFS). Preferably, the primary packaging has a volume of 1 ml to 3 ml. In particular, the volume is 1 ml (long format), 1 ml, or 2.25 ml. 212220 PCT - KO-HF 2024-01

[0032] 8

[0033] In particular, the primary packaging includes an injection end protection cap, especially a needle shield, which covers the injection end, specifically by being attached to the injection end, so that accidental puncture is prevented. Specifically, the pre-filled syringe (PFS) includes the injection end protection cap – also known as a rigid needle shield.

[0034] In one embodiment, the pressure medium is a gas, in particular air, which is drawn in and compressed by the pressure generating device in order to apply the dispensing pressure to the plug of the primary packaging material when the primary packaging material is arranged in the primary packaging receptacle.

[0035] In the context of this technical teaching, dispensing pressure is understood to mean, in particular, an instantaneous pressure of the pressure medium acting on the back side of the plug. Specifically, the dispensing pressure is locally constant along a pressure line path from the pressure-generating device to the pressure chamber of the primary packaging material, since there are no or only negligible local pressure differences due to dynamic flow, especially dynamic pressure components. In particular, several dispensing pressures from different, especially subsequent, points in time constitute the temporal dispensing pressure profile. Specifically, the dispensing pressure profile is either discrete, i.e., exhibits specific dispensing pressure values, or continuous, i.e., exhibits a continuous pressure profile.

[0036] According to a further development of the invention, the pressure generating device comprises a drive device and a compressor device. The compressor device is connected to the pressure line in a pressure-conducting manner, the drive device being designed and configured to drive the compressor device, and the compressor device being designed and configured to apply the dispensing pressure to the movable plug via the pressure line.

[0037] The compressor device compresses the pressure medium, in particular gas, especially air, with particular efficiency. Since compressor devices are available on the market in various sizes, a compressor device that is comparatively compact and small in design is preferred here, so that it can be completely arranged within the injection body, and in particular, fixed within it.

[0038] 212220 PCT - KO-HF 2024-01

[0039] 9

[0040] In one embodiment, the drive device is designed as the sole drive device, in particular as the sole drive, of the injection device. In another embodiment, the injection device has a gear unit, wherein the drive device is operatively connected to the gear unit to achieve a

[0041] to introduce drive torque into the transmission device. In particular, the

[0042] The gearbox device is drive-connected to the compressor device in order to...

[0043] To introduce the drive torque of the drive device, in particular as an output torque of the gearbox device, into the compressor device in order to apply the discharge pressure to the movable plug, particularly via the pressure line.

[0044] In one embodiment, the compressor device includes a compressor or is designed as a compressor. In the context of this technical teaching, a compressor is understood to be, in particular, a fluid energy machine that supplies mechanical work to an enclosed gas, especially the pressure medium. Preferably, the mechanical work is supplied by means of a piston compressor. However, other embodiments are also conceivable, such as, for example, a screw compressor. The compressor device specifically includes a pressure outlet to which the pressure line is connected, and in particular attached, to the first line end. The compressor device also specifically includes an intake inlet designed and arranged such that the pressure medium, in particular gas, especially air, is drawn in from the surrounding environment.In particular, the injection body has at least one corresponding intake opening which is partially congruent with the intake inlet, so that the gas, in particular air, flows from the environment through the intake opening into the intake inlet of the compressor device when the drive device drives the compressor device.

[0045] According to a further development of the invention, the injection device comprises an energy storage device and an electric drive device. The energy storage device is electrically connected to the electric drive device and configured to store and release electrical energy for the electric drive device. The electric drive device is designed and configured to apply the dispensing pressure to the movable plug by means of the pressure medium.

[0046] 212220 PCT - KO-HF 2024-01

[0047] 10

[0048] The injection device is advantageously designed as a mobile, and in particular portable, device, especially a handheld device, due to its energy storage device. In particular, it is not necessary for the injection device to be connected to a power supply, especially a wall socket, during an injection. The injection device can be freely positioned, allowing injections to be carried out successively in different locations, especially in different rooms, without having to disconnect the power supply (i.e., unplug the device) and reconnect it at a different location (i.e., plug it back in). Furthermore, it is advantageously possible to recharge the injection device during periods of inactivity when no injections are being performed, especially overnight.Advantageously, the energy storage device has an energy storage capacity sufficient to perform several injections at least on one day, and in particular several injections on several days, without having to recharge the energy storage device in between.

[0049] In one embodiment, the energy storage device is an electrochemical energy storage device. In another embodiment, the energy storage device is permanently installed in the injection base body. In particular, it is not intended that a user remove the energy storage device from the injection base body for charging and reinsert it. Specifically, the injection base body has a charging socket for charging the energy storage device. Specifically, the energy storage device can be charged by means of an electrical charging device that is plugged into the charging socket. In another embodiment, the energy storage device is designed as at least one commercially available battery, in particular as a micro battery, specifically an AA or AAA battery.In particular, the injection unit body has a battery compartment covered by a removable cover. If the battery charge is too low to perform an injection, the cover can be removed and the battery replaced, specifically with a fully charged battery.

[0050] In one embodiment, the electric drive device is designed as the sole drive device, in particular as the only drive, of the injection device.

[0051] 212220 PCT - KO-HF 2024-01

[0052] 11 In one embodiment, the electric drive device is designed and configured to drive the compressor device, in particular via the gearbox, and to apply the discharge pressure to the movable plug via the pressure line using the compressor device.

[0053] According to a further development of the invention, the injection device includes a primary packaging material detection device. The

[0054] Primary packaging detection device designed and configured to detect whether a primary packaging material is received in the primary packaging receptacle, in particular held, in particular arranged therein, in particular inserted therein.

[0055] The primary packaging detection device offers the advantage of allowing for quick and easy detection of whether a primary packaging material is received, and in particular held, in the primary packaging receptacle. Specifically, it enables at least one function of the injection device to be enabled, and in particular activated, or disabled, and in particular deactivated, depending on whether a primary packaging material is received, and in particular held, in the primary packaging receptacle.

[0056] In one embodiment, the primary packaging detection device has a mechanical push button that is arranged and configured to be actuated when the primary packaging is received, and in particular held, in the primary packaging receptacle. Specifically, the push button has two switching states: an "inserted" switching state, in which the primary packaging is received, and in particular held, in the primary packaging receptacle, and an "empty" switching state, in which the primary packaging is not received, and in particular not held, in the primary packaging receptacle. Specifically, when the primary packaging is inserted into the primary packaging receptacle, the push button is switched to the "inserted" switching state by the primary packaging itself—in particular, due to the primary packaging striking the push button, or in particular, due to pressure exerted against the push button.In particular, when the primary packaging material is removed, the button is switched to the empty switching state by the primary packaging material receptacle, especially because the primary packaging material no longer acts on the button after removal and the button has a return element, in particular a spring, which forces the switch into the empty switching state. In another embodiment, the primary packaging material detection device has a

[0057] 212220 PCT - KO-HF 2024-01

[0058] 12. Optical detection device, in particular an optical sensor, which is arranged and configured to detect whether the primary packaging material is received, in particular held, in the primary packaging receptacle. In particular, the optical detection device detects a change in brightness due to the presence of the primary packaging material. In particular, the primary packaging detection device is configured to generate an electrical insertion signal when the primary packaging material is received, in particular held, in the primary packaging receptacle or not, and to transmit the electrical insertion signal to a control device of the injection device. In particular, the electrical insertion signal contains information as to whether the primary packaging material is received, in particular held, in the primary packaging receptacle or not.

[0059] Alternatively or additionally to the primary packaging material handling device, the primary packaging material holder has at least one locking element, wherein the packaging material base or the packaging material frame has a counter-locking element. In particular, the locking element and the counter-locking element are designed and interact such that the primary packaging material locks into place in the primary packaging material holder with an audible click. This design is advantageously particularly cost-effective to manufacture.

[0060] According to a further development of the invention, the injection device has a pressure sensor. The pressure sensor is arranged and configured to detect pressure, in particular the application pressure, and especially the application pressure profile over time, in the pressure line.

[0061] Advantageously, the pressure sensor makes it possible to monitor at least one pressure-related function of the injection device, particularly a pressure-influencing and pressure-dependent function, and especially to detect smooth operation of the injection device as well as any deviations from smooth operation. In particular, the at least one pressure-influencing and pressure-dependent function could be selected from a group consisting of: an energy storage function, specifically whether the energy storage device has a sufficient charge; a pressure generation device function, specifically whether the pressure generation device is functional; and a sealing function, specifically whether the pressure line path of the

[0062] 212220 PCT - KO-HF 2024-01

[0063] 13

[0064] The pressure medium is leak-free, and an injection function, in particular whether the plug is displaced and the pharmaceutical substance is injected.

[0065] In one embodiment, the pressure sensor is arranged in the pressure line path of the pressure line. In particular, the pressure sensor is arranged and configured to detect an instantaneous pressure in the pressure line. In another embodiment, the pressure sensor is configured to generate an electrical pressure signal and to transmit this electrical pressure signal to the control device of the injection device. Specifically, the electrical pressure signal contains information about the value of the measured pressure.

[0066] According to a further development of the invention, the injection device has a movable pressure medium interface. The pressure line, in particular with a second line end different from the first line end, opens into the pressure medium interface. The pressure medium interface is arranged and configured to be moved between the connected position, in which the pressure line is pressure-conductingly connected to the primary packaging material, in particular to the movable plug, and the disconnected position, in which the pressure line is separated from the primary packaging material, in particular pressure-decoupled from the movable plug.

[0067] The pressure medium interface allows the primary packaging material to be connected to and disconnected from the pressure line in a pressure-conducting manner, particularly easily and quickly, especially semi-automatically or automatically, using a pressure-conducting interface.

[0068] In one embodiment, the pressure medium interface is arranged in a pressure-conducting manner at the second end of the pressure line. In particular, the second end of the line is attached to the pressure medium interface. In another embodiment, the pressure medium interface has a pressure line channel that extends through the pressure medium interface. In particular, the pressure medium interface has a first channel opening and a second channel opening, which are arranged opposite each other at the pressure medium interface and are connected to each other in a pressure-conducting manner by means of the pressure line channel. In particular, the pressure line, especially the second end of the pressure line, is connected to the first channel opening in a pressure-conducting manner. In particular, the second channel opening opens when the 212220 PCT - KO-HF 2024-01

[0069] 14

[0070] The primary packaging material is inserted into the primary packaging holder and the pressure medium interface is in the connected position, into the pressure chamber of the primary packaging material. In particular, the second channel opening is pressure-conducting with the

[0071] primary packaging material connected, so that in particular the pressure generated by the pressure generating device, especially the dispensing pressure, passes through the pressure line and the

[0072] The pressure line extends to the pressure chamber and the plug, and the plug is pressurized with the application pressure. In one embodiment, the pressure sensor is arranged in a pressure line path of the pressure line. In particular, the pressure sensor is arranged and configured to detect a pressure, especially an instantaneous pressure, particularly the application pressure, in the pressure line.

[0073] In one embodiment, the pressure medium interface is arranged and configured to be moved along a central axis of the primary packaging between the bonded position and the separated position. In particular, when moving into the bonded position, the pressure medium interface is inserted section by section into the primary packaging, specifically retracted, while when moving into the separated position, the pressure medium interface is moved section by section, specifically completely, out of the primary packaging.

[0074] As an alternative to locking the primary packaging material by means of the packaging locking device, in another embodiment the primary packaging material is only locked in the connected position in the injection device, in particular such that the primary packaging material cannot be removed from the primary packaging receptacle. Specifically, locking the primary packaging material in the connected position is achieved by having the pressure medium interface partially contact the primary packaging material, thereby blocking its removal from the injection device. In particular, the primary packaging material is released in the disconnected position, so that it can be removed from the primary packaging receptacle.

[0075] In one embodiment, the pressure medium interface has a position detection device which is arranged and configured to detect whether the pressure medium interface is in the connected position or in the disconnected position.

[0076] 212220 PCT - KO-HF 2024-01

[0077] 15

[0078] According to a further development of the invention, the pressure medium interface has an expandable sealing element for sealing the pressure medium interface to the primary packaging material, wherein the expandable sealing element is connected to the pressure line in a pressure-conducting manner.

[0079] The expandable sealing element advantageously ensures a cost-effective and preferably leak-free seal between the pressure medium interface and the primary packaging. The expandable sealing element expands solely due to the pressure generated by the pressure-generating device, in particular the dispensing pressure, so that no moving parts, and especially no complex mechanical displacement and sealing mechanisms, are necessary.

[0080] In one embodiment, the expandable sealing element is hollow and limits an expansion volume, at least in sections. In particular, the expandable sealing element, together with the pressure medium interface, limits the expansion volume. Specifically, the expandable sealing element has an elastic sealing element wall, wherein at least one section, and in particular two sections, of the sealing element wall are attached to the pressure medium interface, and in particular connected to it, and in particular connected without leakage. Specifically, the expansion volume is limited in sections—with the exception of at least one sealing element supply channel—by means of an interface wall between the pressure medium interface and the sealing element wall.In particular, the pressure medium interface has at least one sealing element supply channel, and in particular two sealing element supply channels, which connects the pressure generating device to the expansion volume in a pressure-conducting manner. In particular, the sealing element supply channel branches off from the pressure line channel and opens into the expansion volume. In particular, the two sealing element supply channels branch off from the pressure line channel at two opposite pressure line channel sections. In particular, the expandable sealing element has an elastic material, in particular an elastic plastic, in particular rubber, or is made of an elastic material, in particular an elastic plastic, in particular rubber.

[0081] 212220 PCT - KO-HF 16

[0082] In one embodiment, the expandable sealing element is designed and arranged to expand in the connected position when the movable plug is subjected to the dispensing pressure, particularly due to the dispensing pressure, and to be forced to seal against the primary packaging material, especially when the pressure medium introduced into the pressure line by the pressure generating device flows into the expansion volume. In particular, the pressure generated by the pressure generating device, especially the dispensing pressure, acts directly, particularly immediately, and especially originating from the expansion volume, on the expandable sealing element and expands it. In particular, the pressure, especially the dispensing pressure, acts on a first side of the sealing element wall facing the expansion volume.In particular, the expandable sealing element is pressed against the primary packaging material with one of the two sides of the sealing element wall opposite the first side in relation to the sealing element wall.

[0083] According to a further development of the invention, the pressure medium interface is inserted at least section by section into the primary packaging material in the connected position along an insertion direction. Here, the expandable sealing element, particularly within the primary packaging material, surrounds an insertion section of the pressure medium interface in an annular manner and is arranged locally between the insertion section and the primary packaging material in the connected position.

[0084] Advantageously, an annular gap is formed between the insertion section and the primary packaging, particularly within the primary packaging, in which the expandable sealing element is arranged. This ensures a virtually leak-free seal between the insertion section and the primary packaging when the expandable sealing element is expanded. Furthermore, it is advantageous that the expandable sealing element does not expand when the pressure medium interface is moved into the connected or disconnected position, and thus has a smaller diameter, making it easier to insert or remove the insertion section from the primary packaging.

[0085] In one embodiment, the insertion section is cylindrical, in particular circular cylindrical. In particular, the insertion section has the second

[0086] 212220 PCT - KO-HF 2024-01

[0087] 17

[0088] The channel opening of the pressure line channel leads into the pressure chamber of the primary packaging. In particular, the insertion section has an insertion chamfer that annularly surrounds the second channel opening and simplifies the insertion of the insertion section into the primary packaging. Specifically, a cylinder axis of the insertion section is oriented parallel to or congruent with the insertion direction when the insertion section is inserted section by section into the primary packaging. In particular, the expandable sealing element expands radially with respect to the cylinder axis when subjected to pressure, especially dispensing pressure, and in particular additionally in at least one axial direction, especially in two axial directions, which are preferably opposite.

[0089] In one embodiment, the expandable sealing element, particularly within the primary packaging material—especially when the insertion section with the expandable sealing element is inserted section by section into the primary packaging material—encircles the pressure line channel in an annular manner, and particularly the insertion direction in an annular manner. In another embodiment, the expandable sealing element, particularly the sealing element wall, is annular in shape. Specifically, the sealing element wall partially encircles a circumferential direction that surrounds the pressure line channel. Specifically, the sealing element wall has a cross-section, particularly a radial section, open towards the pressure medium interface, particularly towards the interface wall, with respect to the cylinder axis of the insertion section. Specifically, the two sections of the sealing element wall are arranged opposite each other and spaced apart from each other, particularly with respect to the expansion volume.In particular, the two sections are connected to each other by means of a third section of the sealing element wall, so that the cross-section, in particular radial section, is C-shaped, with one open side of the C-shape facing the interface wall.

[0090] According to a further development of the invention, the pressure medium interface has an elastic second sealing element that is different from the expandable sealing element and is arranged and designed in such a way that the second sealing element is pressed against the primary packaging material in the connected position.

[0091] 212220 PCT - KO-HF 2024-01

[0092] 18

[0093] The second sealing element advantageously ensures an improved seal between the pressure medium interface and the primary packaging. In particular, the second sealing element is designed as an O-ring, which is relatively inexpensive and readily available on the market.

[0094] In one embodiment, the O-ring comprises an elastic material, in particular an elastic plastic, in particular a rubber, or is made of an elastic material, in particular an elastic plastic, in particular a rubber.

[0095] According to a further development of the invention, the second sealing element surrounds the insertion section in a ring shape and is arranged along the insertion direction in front of the expandable sealing element.

[0096] The fact that the second sealing element is arranged upstream of the expandable sealing element along the insertion direction means, in the context of the present technical teaching, in particular that when the insertion section is inserted into the primary packaging material in stages, especially when the pressure medium interface is moved into the connected position, the second sealing element is inserted into the primary packaging material first, followed by the expandable sealing element. Specifically, the second sealing element and the expandable sealing element are spaced apart from each other along the cylinder axis of the insertion section. In particular, the second sealing element is arranged closer to the second channel opening of the pressure medium interface than the expandable sealing element.

[0097] In one embodiment, the insertion section has an annular groove, particularly one that encompasses the cylinder axis, in which the second sealing element is arranged, and in particular inserted. The groove is open radially outwards with respect to the cylinder axis. The second sealing element has an outer diameter that is larger than the inner diameter of the primary packaging, so that the second sealing element is advantageously pressed against the primary packaging and the base of the groove in the connected position. In one embodiment, the second sealing element encompasses the pressure line channel and, in particular, the insertion direction in an annular manner, particularly within the primary packaging. The second sealing element also encompasses the insertion section in an annular manner.

[0098] 212220 PCT - KO-HF 2024-01

[0099] 19

[0100] According to a further development of the invention, the injection device includes a pressure adjustment device. The pressure adjustment device is configured to adjust the application pressure, in particular to set the application pressure profile over time.

[0101] Advantageously, the pressure adjustment device is configured to adapt, and in particular reduce, the raw pressure generated by the pressure-generating device to the application pressure, especially to the pressure profile over time. The raw pressure is, in particular, the pressure obtained when the pressure-generating device is operated continuously, especially for a predetermined duration. It is advantageously possible to perform various injections with different application pressures. In particular, this allows for setting an injection time, with higher application pressures resulting in faster injections, especially shorter injection times, and lower application pressures resulting in slower injections, especially longer injection times. Furthermore, it is advantageously possible to adjust the application pressure to the viscosity of the pharmaceutical substance.In particular, a pharmaceutical substance with a comparatively high viscosity is injected at a higher delivery pressure than a pharmaceutical substance with a comparatively low viscosity. This allows for similar injection times to be achieved with pharmaceutical substances of different viscosities.

[0102] In one embodiment, the pressure adjustment device is designed as a pressure valve. In particular, the pressure valve is configured to switch continuously, especially steplessly, between an open position, a closed position, and at least one intermediate position. In another embodiment, the pressure adjustment device does not have a pressure valve; instead, the result of the pressure valve, in particular different output pressures, is achieved by the pressure generation device itself, which is configured to operate at different power levels. Specifically, the pressure generation device generates different output pressures at different power levels.In particular, when injecting a pharmaceutical substance with a comparatively high viscosity, a higher power level and thus a higher delivery pressure is used than when injecting a pharmaceutical substance with a comparatively low viscosity. In particular, this can...

[0103] 212220 PCT - KO-HF 20 thus similar injection times can be achieved with pharmaceutical substances of different viscosities.

[0104] According to a further development of the invention, the injection device includes a packaging repositioning device. The packaging repositioning device is configured to reposition the primary packaging receptacle, particularly together with the primary packaging when the primary packaging is received in the primary packaging receptacle, relative to the injection base body between an injection position and a rest position. In this case, the injection end of the primary packaging projects from the injection base body, particularly from the distal end, in the injection position, particularly for an injection, when the primary packaging is received, particularly held, particularly arranged, and particularly inserted in the primary packaging receptacle.The injection end is concealed in the injection base body in the rest position when the primary packaging material is received, in particular held, in particular arranged, in particular inserted in the primary packaging receptacle.

[0105] This allows for the advantageous semi-automated or automated puncturing of a skin surface. After an injection, the injection tip is automatically retracted into the injection base, specifically by moving the primary packaging receptacle into its resting position. This effectively prevents unintended punctures, particularly needlestick injuries, that may occur after the injection is completed.

[0106] In the context of the present technical teaching, the fact that the injection end is concealed in the injection base body in the rest position means in particular that the injection end is completely arranged in the injection base body in the rest position and does not protrude from the injection base body, in particular from the distal end, even partially.

[0107] In one embodiment, the packaging material relocation device is arranged in and attached to the injection base body. In particular, the packaging material relocation device has a relocatable support element, especially a relocatable slide, which is configured to be relocated relative to the injection base body. In one embodiment, the pressure medium interface and / or the 212220 PCT - KO-HF 21

[0108] The pressure adjustment device is connected to the packaging transfer device, in particular the movable support element, and is specifically attached to it and arranged to be moved together with the movable support element, in particular without changing their relative position to each other. In particular, the pressure medium interface is in turn movably attached to the movable support element and arranged to be moved relative to the movable support element.

[0109] In one embodiment, the injection device has an injection release lock which is configured to lock the packaging transfer device in the rest position, in particular to prevent transfer into the injection position when an injection surface detection sensor does not detect contact with an injection surface, in particular a skin surface, and to release the packaging transfer device, in particular to release transfer into the injection position, when the injection surface detection sensor detects contact with the injection surface.

[0110] In one embodiment, the packaging transfer device includes a device position detection device which is arranged and configured to detect whether the primary packaging receptacle is in the injection position or in the rest position.

[0111] According to a further development of the invention, the injection device has a stripping device which is arranged and designed to strip the injection end protective cap of the injection end for an injection when the primary packaging material is received, in particular held, in particular arranged therein, in particular inserted therein, in particular received in the primary packaging material receptacle.

[0112] Advantageously, the injection end cap is removed semi-automatically or automatically. In particular, the injection device can be held with one hand, eliminating the need to manually remove the injection end cap with another hand. Thus, the injection device allows for advantageous single-handed injections.

[0113] In one embodiment, the stripping device has at least one movable, in particular pivotable, stripping element, which is designed and arranged to act on the injection end protection cap and strip it from the injection end. 212220 PCT - KO-HF 2024-01

[0114] 22

[0115] In particular, the wiping device has two wiping elements which are arranged opposite each other with respect to the injection end cap, in particular transversely to the central axis of the primary packaging material, so that in particular a uniform effect on the injection end cap, and in particular a uniform wiping, is enabled. Advantageously, this prevents the injection end cap from sticking, in particular from becoming wedged in or on the injection device.

[0116] In one embodiment, the injection device has an actuable wiper button which is designed and configured to activate the wiper device when the wiper switch is actuated and to wipe off the injection end protection cap.

[0117] According to a further development of the invention, the drive device is operatively connected to the movable pressure medium interface in order to move it between the connected position and the disconnected position. Alternatively or additionally, the drive device is operatively connected to the packaging material relocation device in order to move the primary packaging material receptacle between the injection position and the rest position. Alternatively or additionally, the drive device is operatively connected to the stripping device in order to strip the injection end protection cap from the injection end for injection.

[0118] Advantageously, the drive device allows at least one step of the injection process to be performed semi-automatically or automatically, thus simplifying the overall injection procedure. This eliminates manual steps, particularly those performed by hand, resulting in a smooth injection process. Specifically, the at least one step is selected from a group consisting of: the pressure-conducting connection of the pressure medium interface to the primary packaging material, the removal of the injection end cap, the movement of the primary packaging material receptacle into the injection position, the application of the dispensing pressure to the movable plug, the movement of the primary packaging material receptacle into the rest position, and the movement of the pressure medium interface into the disconnection position.

[0119] In particular, the drive device is drive-actively connected to the pressure medium interface in order to move the pressure medium interface from the connected position to the 212220 PCT - KO-HF 2024-01

[0120] 23

[0121] The drive device is specifically connected to the packaging transfer device to move the primary packaging material holder from the injection position to the rest position and vice versa, and optionally to at least one, and in particular several, intermediate positions.

[0122] In one embodiment, the drive device is driven by means of the transmission device, by means of which the drive device is drivenly connected to the compressor device, to the movable pressure medium interface and / or the packaging material transfer device and / or the stripping device. In one embodiment, the transmission device has at least one switchable clutch device, which is designed and configured to interrupt, in particular to disconnect, a drive torque path, especially between the drive device and an output device selected from the compressor device, the pressure medium interface, the

[0123] Packaging transfer device and stripping device. In particular, the transmission device has a separate coupling device for each output device, which are arranged and configured to selectively open, in particular interrupt, and close, in particular connect, a drive torque path of the respective output device independently of the other output devices.

[0124] According to a further development of the invention, the injection device includes an injection surface detection sensor, which is arranged at a distal end and configured to detect contact with the injection surface, in particular a skin surface, and to automatically generate an injection command. Alternatively or additionally, the injection device includes an injection button, which is configured to manually generate an injection command.

[0125] The injection device offers the advantage of flexible application and the option of starting an injection automatically or manually. In particular, the injection device features an operating mode selector switch configured to determine whether the injection surface detection sensor or the injection button is used to generate the injection command. This allows the user to advantageously determine whether the

[0126] 212220 PCT - KO-HF 24

[0127] The injection device is designed to perform the injection automatically upon contact with the skin surface or only upon activation of the injection button.

[0128] In one embodiment, the injection surface detection sensor is configured to detect contact with the skin surface, in particular, contact with the skin surface. Specifically, the injection surface detection sensor is configured as an optical sensor, a capacitive sensor, or a thermal sensor. In one embodiment, the capacitive sensor has at least one sensor area located at the distal end of the injection base body. In particular, the irritation elements border the sensor area. Preferably, the sensor area is surrounded by the irritation elements. Specifically, the injection surface detection sensor is configured to generate an electrical contact signal and to transmit this electrical contact signal, as the injection command, to the control device of the injection device.In particular, the electrical contact signal contains information about whether the injection surface detection sensor detects contact with the injection surface, especially the skin surface, or not. In another embodiment, the injection button is configured to generate an electrical tactile signal and to transmit this signal as the injection command to the control device of the injection device. In particular, the electrical tactile signal contains information about whether the injection button is actuated or not. In one embodiment, the injection button is arranged laterally, especially in the area of ​​the gripping section, and / or at the proximal end, on the injection base body and is configured to be actuated by a user's finger.In another embodiment, the injection button is arranged at the distal end and configured to be actuated from the skin surface when the injection device is pressed onto the skin surface.

[0129] According to a further development of the invention, the injection device includes the control device. Here, the control device is interconnected with the pressure generation device and / or with the primary packaging material detection device and / or with the pressure sensor and / or with the pressure medium interface and / or with the pressure adjustment device and / or with the packaging material transfer device and / or with the wiper device and / or with the injection surface detection sensor and / or with the injection button in order to carry out an injection upon the injection command.

[0130] 212220 PCT - KO-HF 25

[0131] In particular, the control device is interconnected with the transmission device and with the at least one switchable clutch device.

[0132] Advantageously, the control device executes the steps to be carried out in the intended sequence, thus ensuring a smooth injection process.

[0133] In one embodiment, the control device is interconnected with the pressure generation device to switch the pressure generation device, particularly the drive device, on and off, and to adjust a power level of the pressure generation device. Specifically, the control device is interconnected with the primary packaging detection device to receive the electrical insertion signal from the primary packaging detection device. Specifically, the control device is interconnected with the pressure sensor to receive the electrical pressure signal. Specifically, the control device is interconnected with the pressure medium interface to move the pressure medium interface, particularly by means of the drive device and the at least one gear unit, between the connected position and the disconnected position.In particular, the control device is operatively linked to the pressure adjustment device in order to adjust the dispensing pressure. In particular, the control device is operatively linked to the packaging transfer device in order to...

[0134] The primary packaging material is moved between the injection position and the rest position, in particular by means of the drive device and the at least one gear device. In particular, the control device is interconnected with the stripping device to strip the injection end protection cap for injection. In particular, the control device is interconnected with the injection surface detection sensor and / or the injection button to receive the injection command, in particular the electrical contact signal and / or the electrical touch signal.

[0135] In one embodiment, at least one injection program, in particular an injection method, in particular a control method for the injection device, is stored on the control device, wherein the control device is configured to operate the injection device with the control method, in particular to perform the injection

[0136] 212220 PCT - KO-HF 2024-01

[0137] 26 of a pharmaceutical substance. In particular, the control procedure described below is stored on the control device.

[0138] The embodiments described and statements made in connection with the injection device according to the invention also relate, mutatis mutandis, to the control method described according to the invention and vice versa.

[0139] The problem is also solved by creating a control method for an injection device for injecting a pharmaceutical substance from a primary packaging material, wherein the primary packaging material comprises a packaging material body, in particular with a central axis, a plug that is displaceable, in particular along the central axis, and an injection end, wherein the packaging material body together with the displaceable plug defines a packaging material volume in which the pharmaceutical substance is contained, wherein the plug is displaceable, in particular along the central axis, in particular relative to the packaging material body, in order to dispense the pharmaceutical substance from the packaging material volume by means of the injection end.In this process, the movable plug is subjected to a pressure, particularly a pressure profile over time, by means of a pressure medium, causing the movable plug to shift and the pharmaceutical substance to be dispensed, particularly injected, from the primary packaging. The advantages of this control method are particularly evident in the context of the injection device already described.

[0140] In one embodiment, the movable plug is pressurized by the pressure medium with the dispensing pressure, in particular the pressure profile over time, by means of the pressure medium, in particular by means of the pressure generating device, especially starting from ambient pressure, to a first peak dispensing pressure value that is sufficiently high to displace the movable plug. In particular, the pressure generating device is switched off when the first peak dispensing pressure value is reached. In particular, the displacement of the plug and the associated enlargement of a pressure chamber of the primary packaging material adjacent to the plug and opposite the pharmaceutical substance relative to the plug leads to a decreasing dispensing pressure over time. In particular, the dispensing pressure decreases, especially starting from the first peak dispensing pressure value, over an injection time until a value exceeding the

[0141] 212220 PCT - KO-HF 2024-01

[0142] 27

[0143] The dispensing pressure acting on the plug falls below the minimum displacement force required to overcome the frictional force resulting from the viscosity of the pharmaceutical substance, thus leading to the plug being held in place, specifically to a cessation of its displacement. The initial peak dispensing pressure is selected based on the viscosity of the pharmaceutical substance, with a higher initial peak dispensing pressure being chosen for a pharmaceutical substance with a comparatively high viscosity than for one with a comparatively low viscosity.

[0144] According to a further development of the invention, the movable plug is subjected to an initial application pressure by means of the pressure medium. This initial pressure is lower than a plug-breakdown pressure threshold, above which the movable plug shifts. The application pressure is then increased from the initial application pressure until the plug-breakdown pressure threshold is exceeded and the movable plug shifts.

[0145] Advantageously, this method allows the delivery pressure to be increased relatively cautiously until the stopper-breakdown pressure threshold is exceeded. In particular, this reduces, or preferably eliminates, the injection impulse, as the delivery pressure is only increased to the point where it surpasses the stopper-breakdown pressure threshold. This results in a particularly gentle injection, with the patient preferably perceiving only a reduced, or preferably no, injection impulse at all.

[0146] In one embodiment, the application pressure is continuously increased from the initial application pressure until the plugless breakaway pressure threshold is exceeded. In another embodiment, the application pressure is gradually increased from the initial application pressure until the plugless breakaway pressure threshold is exceeded.

[0147] In one embodiment, the dispensing pressure is increased to the first peak dispensing pressure value, which is only slightly above the stopper breakaway pressure threshold, particularly when the pharmaceutical substance has a dynamic viscosity (r) of less than 60 mPa s. Specifically, the dispensing pressure is not increased further when the stopper is displaced. This results in a particularly gentle injection, but with a comparatively long injection time. In another embodiment, the 212220 PCT - KO-HF 2024-01

[0148] 28

[0149] The application pressure is increased to the first peak application pressure value, which is higher than the plug-less breakout pressure threshold by a first differential application pressure value. In particular, the application pressure is further increased as the plug is displaced until the first peak application pressure value is reached. The first differential application pressure value should be considered primarily as an injection time reduction pressure surcharge, which aims to shorten the injection time.

[0150] According to a further development of the invention, the application pressure is increased at least once more after exceeding the plugless breakaway pressure threshold and displacing the movable plug, in particular by a second differential application pressure value and / or by a differential test peak pressure value.

[0151] This advantageously shortens the injection time. In particular, it makes it possible to inject even relatively viscous pharmaceutical substances with a relatively manageable, and especially short, injection time. Furthermore, it is advantageous to prevent the delivery force of the delivery pressure from falling below the minimum displacement force.

[0152] In one embodiment – ​​when the plug has completely dispensed, in particular injected, the pharmaceutical substance, and has been completely displaced within the packaging body towards the injection end – the plug abuts a shoulder of the primary packaging body. This, in particular, prevents the dispensing pressure from decreasing further, as the pressure chamber no longer expands. Based on the dispensing pressure not decreasing further – which is known via the pressure sensor – it is inferred, in particular, that the pharmaceutical substance has been completely dispensed.Since the pressure sensor cannot distinguish whether the minimum displacement force has been undershot or whether the plug is hitting the shoulder – both of which result in a constant, and in particular, non-decreasing application pressure – it is advantageous to increase the application pressure once more, specifically to raise the test differential peak pressure value to a test peak pressure value below the second peak application pressure value, in order to check whether the plug has stopped before the shoulder or is hitting the shoulder. In particular, if the plug has stopped before the shoulder, increasing the application pressure leads to a further displacement of the plug, which in turn – due to the increase in the pressure chamber – from the test value...

[0153] 212220 PCT - KO-HF 2024-01

[0154] 29

[0155] The peak pressure value leads to a subsequent decrease in the application pressure. In particular, if the plug is already touching the shoulder, increasing the application pressure does not result in any further displacement of the plug and therefore no decrease in application pressure, but rather in a constant application pressure at the pressure level of the test peak pressure value.

[0156] In one embodiment, the application pressure is increased exactly once after exceeding the plugless breakout pressure threshold and displacing the movable plug, specifically by the second differential application pressure value to a second peak application pressure value. In particular, the second peak application pressure value is below or above the first peak application pressure value. In another embodiment, the application pressure is increased several times after exceeding the plugless breakout pressure threshold and displacing the movable plug, specifically first by the second differential application pressure value to the second peak application pressure value and, more specifically, subsequently, particularly after a period of pause between increases, by at least one further differential application pressure value to at least one further peak application pressure value.

[0157] A peak application pressure value, selected from the first peak application pressure value, the second peak application pressure value, the test peak pressure value, and the subsequent peak application pressure value, is in particular an application pressure value at which the previously increasing application pressure, especially the application pressure profile over time, begins to decrease, i.e., in particular, a positive sign of the slope of the application pressure profile changes to a negative sign. In particular, the peak application pressure value is a local extreme value of the application pressure, especially of the application pressure profile over time. In particular, the application pressure profile over time has at least one peak application pressure value, preferably at least two peak application pressure values, namely the first peak application pressure value and the second peak application pressure value.In particular, the application pressure curve includes at least one peak application pressure value, selected from the first peak application pressure value, the second peak application pressure value, the test peak pressure value, and the subsequent peak application pressure value. Specifically, the application pressure curve includes all application pressures detected by the pressure sensor in connection with the injection, in particular from the activation of the injection device, in particular from the start of the injection, in particular 212220 PCT - KO-HF 2024-01.

[0158] 30 from the issuing of the injection command until the end of the injection, in particular until the primary packaging receptacle and the primary packaging held therein are moved together with the end of the injection into the rest position, in particular until the injection device is switched off.

[0159] In particular, the application pressure is increased once or several times depending on at least one increase trigger parameter, wherein the at least one increase trigger parameter is selected from a group consisting of: a time duration, a time interval for increasing, a time-specific application duration, a displacement rate of the plug and a combination of at least two of the aforementioned increase trigger parameters.

[0160] According to a further development of the invention, after exceeding the plugless breakaway pressure threshold and moving the movable plug, the dispensing pressure is kept constant for a predetermined constant pressure period.

[0161] Advantageously, this allows particularly viscous pharmaceutical substances to be injected within a relatively short injection time using the injection device, while simultaneously reducing, and in particular avoiding, the injection pulse.

[0162] In one embodiment, the dispensing pressure is increased to the first peak dispensing pressure value, which is particularly above the stopper breakaway pressure threshold, leading to a displacement of the stopper. This displacement of the stopper results in an increase in the pressure chamber, whereby the resulting decrease in dispensing pressure is compensated for by the continued operation of the pressure-generating device, in particular by not switching it off, and in particular by further compressing the pressure medium, thus maintaining the dispensing pressure constant at the first peak dispensing pressure value. When the stopper has completely dispensed, in particular injected, the pharmaceutical substance, the stopper abuts the shoulder of the primary packaging. Since the pressure medium continues to be compressed, this leads to an increase in the dispensing pressure. This is detected, in particular, by the pressure sensor, which indicates the end of the injection.

[0163] According to a further development of the invention, the application pressure is increased stepwise, in particular iteratively, from the initial application pressure by at least one

[0164] 212220 PCT - KO-HF 2024-01

[0165] 31

[0166] The application pressure increase step is increased, whereby after increasing by one application pressure increase step it is checked whether the movable plug is displaced, in particular whether the plug breakaway pressure threshold is exceeded.

[0167] In this way it is advantageously possible to increase the application pressure only as much as is necessary to displace the plug, resulting in a particularly pleasant injection.

[0168] In one embodiment, it is checked whether the displaceable plug is being moved by measuring the dispensing pressure using the pressure sensor. A constant dispensing pressure is particularly characteristic of a constant pressure chamber, from which it is concluded that the plug has not yet broken free. Furthermore, a decreasing dispensing pressure is particularly characteristic of an increasing pressure chamber, from which it is concluded that the plug has broken free and is being moved.

[0169] According to a further development of the invention, a leak test is carried out before the movable plug is subjected to the pressure medium with the dispensing pressure, in particular with the dispensing pressure profile over time, whereby it is checked whether the pressure generating device and the primary packaging material are connected to each other in a pressure-conducting manner as far as possible, in particular completely without leakage.

[0170] This advantageously ensures that the injection device functions as intended. A pressure-conducting connection that is as leak-free as possible, and ideally completely leak-free, is necessary to adhere to a predetermined injection duration and, more importantly, to be able to perform an injection at all. Without a leak test, it is difficult to detect any existing leakage, as the pressurized medium delivered by the pressure-generating device escapes from the pressure line through the leak. This leads, in particular, to an application pressure that is too low, making injection impossible or preventing its completion.

[0171] According to a further development of the invention, the leak test is carried out by applying a pressure to the movable plug using the pressure medium at a discharge pressure increased to a leak test pressure value, wherein the leak test pressure value is lower than the plug breakaway pressure threshold value, and it is tested whether the leak test pressure is increased to the specified leak test value. 212220 PCT - KO-HF 2024-01

[0172] 32

[0173] The test pressure value remains constant at the increased application pressure, whereby a falling application pressure indicates that the pressure generating device and the primary packaging material are not leak-free and pressure-conductingly connected to each other.

[0174] This method offers the advantage of a simple way to verify that the pressure generation device and the primary packaging material are connected to each other without leakage. No additional components are required for the leak test, as it is performed using the components already present for injection.

[0175] In particular, the leak test pressure value is chosen such that during the leak test the movable plug does not yet shift and the pharmaceutical substance is not yet dispensed from the primary packaging material, in particular injected, wherein the dispensing pressure increased to the leak test pressure value is in particular sufficiently high to force the expandable sealing element to seal against the primary packaging material.

[0176] According to a further development of the invention, the control method is used to operate an injection device according to the invention or an injection device according to one or more of the embodiments described above.

[0177] The following describes three different injection variants as examples of how an injection can be carried out using the injection device operated by the control method. The following description is not exhaustive, so steps, especially user steps or process steps, may be added or existing, optional steps omitted.

[0178] In the first injection procedure, referred to as the active variant, the injection device is switched on by the user using the on / off switch. At this stage, no primary packaging material has yet been inserted into the primary packaging holder. The primary packaging holder is in the rest position, and the pressure medium interface is in the disconnect position. Furthermore, all sensors are deactivated. The electrical injection release lock is also active, which locks the packaging transfer device, thus preventing any injection. The user then activates the release / lock switch, which unlocks the primary packaging holder, allowing the user to insert a pharmaceutical 212220 PCT - KO-HF 2024-01

[0179] 33

[0180] The user can insert the substance-filled primary packaging into the primary packaging receptacle. The primary packaging detection device detects the inserted primary packaging and locks it in the receptacle. The pressure medium interface then moves from the disconnect position to the connected position, thus connecting the primary packaging to the pressure generating device. The user activates the wiper switch, whereupon the injection end protection cap is automatically removed by the wiper. The injection device is now fully prepared for injection and ready for use. The user grasps the injection device and places the distal end onto the patient's skin.The injection surface detection sensor detects contact with the skin surface and deactivates the injection release lock. Immediately afterward, the packaging repositioning device automatically repositions the packaging receptacle and the primary packaging it holds, along with the injection tip, and punctures the patient's skin. The injection device performs a leak test by having the pressure generation device increase the delivery pressure to the leak test pressure value. This forces the expandable sealing element against the primary packaging to seal it against the pressure medium interface. After a successful leak test, the pressure generation device increases the delivery pressure to the first peak delivery pressure value. When the stopper breakaway pressure threshold is exceeded, the stopper repositions and the pharmaceutical substance is injected.Here, the delivery pressure is optionally increased a further time, specifically to the second peak delivery pressure value. Once the stopper has been fully mobilized, it strikes the shoulder of the primary packaging body, at which point the delivery pressure stops decreasing. This is detected by the pressure sensor, which indicates the end of the injection. The primary packaging receptacle then moves to its rest position, withdrawing the injection end from the patient's skin surface and concealing it within the injection body. The pressure generation device is switched off, and the electrical injection release lock is reactivated. The user activates the release / lock switch, which unlocks the primary packaging receptacle, allowing the user to remove the empty primary packaging from the receptacle.The user switches off the injection device using the on / off switch and optionally places it in a charging device or plugs it in.

[0181] 212220 PCT - KO-HF 2024-01

[0182] 34. Insert a charging cable of a charger into the charging socket to charge the energy storage device of the injection device.

[0183] A second injection procedure, referred to as a hybrid variant, is identical to the first with the following difference: The injection device does not have a stripping mechanism that automatically removes the injection end cap. Instead, the injection end cap has a gripping element that protrudes from the injection body at the distal end. The user grasps this element with one hand and manually pulls the injection end cap off the injection end. The remaining procedure is identical to the first injection procedure.

[0184] A third injection procedure, referred to as the passive variant, is identical to the second procedure with the following difference: After the injection release lock is deactivated, the packaging repositioning device does not automatically reposition the primary packaging receptacle and the primary packaging held within it, along with the injection tip, due to the injection device resting on the patient's skin. Instead, the primary packaging receptacle remains in its resting position. Only when the user manually activates the injection switch does the packaging repositioning device move the primary packaging receptacle and the primary packaging held within it, along with the injection tip, into the injection position and puncture the patient's skin. The remaining procedure is identical to the second injection procedure.

[0185] The invention will be explained in more detail below with reference to the drawing. The drawing shows:

[0186] Figure 1 shows a schematic representation of a first embodiment of a

[0187] Injection device for injecting a pharmaceutical substance,

[0188] Figure 2 shows a schematic representation of a second embodiment of a

[0189] Injection device for injecting a pharmaceutical substance in a first view,

[0190] Figure 3 shows a schematic representation of the injection device of Figure 2 in a second view,

[0191] 212220 PCT - KO-HF 2024-01

[0192] 35

[0193] Figure 4 shows a schematic representation of a pressure medium interface of the injection device of Figure 2 in a first and a second view.

[0194] Figure 5 shows a schematic representation of the printing medium interface of Figure 4 in a third view.

[0195] Figure 6 shows different application pressure profiles when injecting a pharmaceutical substance with the injection device of Figure 2, and

[0196] Figure 7 shows a schematic, partially enlarged representation of the proximal end of the injection device of Figure 2.

[0197] Figure 1 shows a schematic representation of a first embodiment of an injection device 1 for injecting a pharmaceutical substance.

[0198] The injection device 1 comprises an injection body 3 having a distal end 5 and a proximal end 7 opposite the distal end 5, wherein the distal end 5 faces a skin surface 9 into which the pharmaceutical substance is injected, and the proximal end 7 faces away from the skin surface 9. The injection body 3 is designed as a housing for the injection device 1. The housing is box-shaped, in particular cuboid, and has recessed gripping sections 11 for gripping by a user. Optionally, the gripping sections 11 have a friction-enhancing material, in particular a plastic, in particular a rubber, and optionally a friction-enhancing surface structure, in particular a textured surface.

[0199] The injection device 1 further comprises an injection surface detection sensor 13, which is arranged at the distal end 5 and configured to detect contact with the skin surface 9 and to automatically generate an injection command. Additionally, the injection device 1 comprises an injection button 12, which is configured to manually generate an injection command when the injection button 12 is pressed by a user. The injection button 12 is arranged, in particular, in the area of ​​the gripping cut 11 and / or at the proximal end 7, with both variants shown here for illustrative purposes. In this case, the injection surface detection sensor 13 is designed as a capacitive sensor, which has at least one sensor area 15 that is attached to

[0200] 212220 PCT - KO-HF 36 is arranged at the distal end 5 of the injection base body. The sensor surface 15 is surrounded by several irritation elements 17, in particular pointed elements, which project transversely, in particular orthogonally, from the distal end 5.

[0201] Figure 2 shows a schematic representation of a second embodiment of an injection device 1 for injecting a pharmaceutical substance in a first view, in particular a front view.

[0202] Identical and functionally equivalent elements are provided with the same reference symbols in all figures, so that reference is made to the preceding description in each case.

[0203] The injection device 1 comprises the injection base body 3, which includes a primary packaging receptacle 19 and a pressure generation device 21 (see Figure 3) with a pressure line 23. The primary packaging receptacle 19 is designed and configured to receive, and in particular to hold, a primary packaging material 25, in particular in an exchangeable manner, and in particular such that the primary packaging material 25 can be arranged, and in particular inserted, in the primary packaging receptacle 19 in an exchangeable manner. The pressure line 23 is designed and configured to connect the pressure generation device 21 to the primary packaging material 25 in a pressure-conducting manner, in particular when the primary packaging material 25 is received, and in particular held, arranged, and in particular inserted, in the primary packaging receptacle 19.The pressure generating device 21 is configured to apply a pressure medium with a discharge pressure, in particular a time-dependent discharge pressure profile, to a movable plug 29 of the primary packaging 25, which limits a packaging volume 27 of the primary packaging 25, via the pressure line 23, which is pressure-conductingly attached to the pressure generating device 21 with a first line end 31.1, when the primary packaging 25 is received in the primary packaging receptacle 19, in particular so that the movable plug 29 is displaced along a central axis 33 of the primary packaging 25 shown in dashed lines, such that the packaging volume 27 is reduced, so that the pharmaceutical substance is dispensed, in particular injected, from the primary packaging 25 by means of an injection end 35, which is covered here by an injection end protective cap 47.

[0204] 212220 PCT - KO-HF 2024-01

[0205] 37

[0206] The injection device 1 further comprises a primary packaging detection device 37. The primary packaging detection device 37 is designed and configured to detect whether a primary packaging material 25 is received, in particular held, in particular arranged therein, in particular inserted therein, in particular received, in the primary packaging receptacle 19.

[0207] The injection device 1 further comprises a movable pressure medium interface 39, which is described in detail in Figure 4. The pressure medium interface 39 is arranged and configured to be moved between a connected position, in which the pressure line 23 is pressure-conductingly connected to the primary packaging material 25, in particular to the movable plug 29, and a disconnected position, in which the pressure line 23 is separated from the primary packaging material 25, in particular pressure-decoupled from the movable plug 29, as indicated by a double arrow A.

[0208] The injection device 1 further comprises a pressure sensor 41, which is arranged in the pressure medium interface 39. The pressure sensor 41 is arranged and configured to detect pressure, in particular the application pressure, and especially the application pressure profile over time, in the pressure line 23.

[0209] The injection device 1 further comprises a packaging repositioning device 43. The packaging repositioning device 43 is configured to reposition the primary packaging receptacle 19, particularly together with the primary packaging 25 when the primary packaging 25 is received in the primary packaging receptacle 19, relative to the injection base body 3 between an injection position and a rest position – represented by a double arrow B. In this position, the injection end 35 of the primary packaging 25 projects from the injection base body 3, particularly from the distal end 5, when the primary packaging 25 is received, held, arranged, or inserted in the primary packaging receptacle 19.The injection end 35 is concealed in the rest position within the injection base body 3 when the primary packaging material 25 is received, in particular held, arranged, or inserted in the primary packaging material receptacle 19. The packaging material transfer device 43 includes a device position detection device 38, which is arranged and configured to detect whether the primary packaging material receptacle 19 is in the injection position or in the rest position.

[0210] 212220 PCT - KO-HF 2024-01

[0211] 38

[0212] The injection device 1 further comprises a stripping device 45 which is arranged and designed to strip an injection end protective cap 47 of the injection end 35 for an injection when the primary packaging material 25 is received in the primary packaging receptacle 19, in particular held, in particular arranged therein, in particular inserted therein.

[0213] The injection device 1 further includes the injection surface detection sensor 13, which is located at the distal end 5 and is configured to detect contact with the skin surface 9 and to automatically generate an injection command.

[0214] Figure 3 shows a schematic representation of the injection device 1 of Figure 2 in a second view, in particular a rear view.

[0215] The pressure generating device 21 further comprises a drive device 49 and a compressor device 51. The compressor device 51 is connected to the pressure line 23 in a pressure-conducting manner, the drive device 49 being designed and configured to drive the compressor device 51, the compressor device 51 being designed and configured to apply the discharge pressure to the movable plug 29 via the pressure line 23.

[0216] The injection device 1 further comprises a gear unit 53, wherein the drive device 49 is connected to the compressor device 51 by means of the gear unit 53.

[0217] The injection device 1 further comprises an energy storage device 55 and an electric drive device 50 as the drive device 49. The energy storage device 55 is electrically connected to the electric drive device 50 and configured to store and release electrical energy for the electric drive device 50. The electric drive device 50 is designed and configured to apply the dispensing pressure to the movable plug 29 by means of the pressure medium – mediated via the compressor device 51.

[0218] The drive device 49 is operatively connected to the movable pressure medium interface 39 in order to move it between the connected position and the disconnected position. Additionally, the drive device 49 is connected to the packaging material relocation device 43 in order to

[0219] 212220 PCT - KO-HF 2024-01

[0220] 39

[0221] The primary packaging receptacle 19 is moved between the injection position and the rest position and is drive-connected. Additionally, the drive device 49 is drive-connected with the stripping device 45 to strip the injection end protection cap 47 of the injection end 35 for injection.

[0222] The injection device 1 further comprises a control device 59. The control device 59 is interconnected with the pressure generation device 21, the primary packaging material detection device 37, the pressure sensor 41, the pressure medium interface 39, the packaging material transfer device 43, the wiper device 45, and the injection surface detection sensor 13 to carry out an injection upon the injection command. Furthermore, the control device 59 is interconnected with the transmission device 53 and with at least one switchable clutch device (not shown).

[0223] Figure 4 shows a schematic representation of a pressure medium interface 39 of the injection device 1 of Figure 2. Partial figure 4a shows the pressure medium interface 39 in a first view and partial figure 4b shows the pressure medium interface 39 in a second view, in particular a sectional view.

[0224] The pressure line 23, shown here in simplified form, terminates in the pressure medium interface 39 at a second line end 31.2, which differs from the first line end 31.1. The pressure medium interface 39 has an expandable sealing element 61 for sealing the pressure medium interface 39 to the primary packaging material 25, the expandable sealing element 61 being pressure-conductingly connected to the pressure line 23. The pressure medium interface 39 also has a second elastic sealing element 62, distinct from the expandable sealing element 61, which is arranged and designed such that the second sealing element 62 is pressed against the primary packaging material 25 in the connected position. The second sealing element 62 surrounds an insertion section 63 in an annular manner and is arranged along an insertion direction 65 – indicated by an arrow – in front of the expandable sealing element 61.

[0225] The pressure medium interface 39 has a pressure line channel 67 that runs through the pressure medium interface 39 along a channel axis 64. The pressure medium interface 39 has a first channel opening 69.1 and a second channel opening 212220 PCT - KO-HF 40

[0226] 69.2, which are arranged opposite each other at the pressure medium interface 39 and are connected to each other in a pressure-conducting manner via the pressure line channel 67. The pressure line 23, in particular the second line end 31.2 of the pressure line 23, is connected to the first channel opening 69.1 in a pressure-conducting manner. The pressure medium interface 39 has two sealing element supply channels 71. The sealing element supply channels 71 branch off from the pressure line channel 67 and open into an expansion volume 73 of the expandable sealing element 61.

[0227] Figure 5 shows a schematic representation of the printing medium interface 39 of Figure 4 in a third view.

[0228] The pressure medium interface 39 is inserted, at least partially, into the primary packaging material 25, in particular into a packaging base body 26, in the connected position shown here along the insertion direction 65. The expandable sealing element 61, particularly within the primary packaging material 25, surrounds the insertion section 63 of the pressure medium interface 39 in an annular manner and is located between the insertion section 63 and the primary packaging material 25 in the connected position. A flow path of the pressure medium is shown by arrows C. The pressure medium flows into the expansion volume 73 and expands the expandable sealing element 61, so that it is forced against the packaging base body 26.Also recognizable are two sections 68 of a sealing element wall 66 of the expandable sealing element 61, which are connected to each other by means of a third section 70 of the sealing element wall 66, so that the cross-section shown by means of a dashed line 72, in particular radial section, is C-shaped.

[0229] Figure 6 shows different application pressure profiles when injecting a pharmaceutical substance with the injection device 1 of Figure 2.

[0230] At that time to, the output pressure is at the level of the ambient pressure, in particular at 1013.25 hPa, since the pressure generating device 21 is switched off.

[0231] The pressure generating device 21 increases the dispensing pressure to a leak test pressure value from time to time t1 until time t2. The injection device 1 performs a leak test, which is completed at time t2.

[0232] 212220 PCT - KO-HF 41

[0233] Upon successful leak testing, the pressure generating device 21 increases the dispensing pressure from time t2 to time t3 to an initial peak dispensing pressure value that is above the stopper-breaking pressure threshold. When the dispensing pressure exceeds the stopper-breaking pressure threshold, the stopper 29 of the primary packaging 25 is displaced and the injection of the pharmaceutical substance begins.

[0234] In this embodiment, the application pressure is continuously increased from time t2 until the plugless breakout pressure threshold is exceeded. In another embodiment, not shown here, the application pressure is increased gradually, in particular in stages, from time t2 until the plugless breakout pressure threshold is exceeded.

[0235] The pressure-generating device 21 is switched off at time t3 in a first variant VI, represented by a short-dashed application pressure curve, and in a second variant V2, represented by a solid application pressure curve. Since the pressure chamber of the primary packaging material 25 is enlarged, the application pressure drops until time t4. Variants VI and V2 essentially coincide from time t0 to time t4.

[0236] In the first variant VI, the pressure generating device 21 remains switched off from that point onward, and the dispensing pressure continues to fall until it reaches the minimum displacement pressure threshold at time t? Below this threshold, the dispensing force can no longer overcome the frictional force present due to the viscosity of the pharmaceutical substance. When the dispensing pressure falls below the minimum displacement pressure threshold, the plug 29 comes to a stop.

[0237] In the second variant V2, the pressure generating device 21 is switched on at time t4. The pressure generating device 21 increases the application pressure to a second peak application pressure value by time ts. At time ts, the pressure generating device 21 is switched off. The application pressure then falls from this second peak application pressure value until, at time te, it reaches the minimum displacement pressure threshold and the plug 29 comes to a stop. It is particularly noticeable that the further increase in application pressure to the second peak application pressure value reduces the injection time – from t? to E.

[0238] 212220 PCT - KO-HF 2024-01

[0239] 42

[0240] In a third variant V3, represented by a long-dashed dispensing pressure curve, the pressure generating device 21 remains switched on beyond time t3 – as an alternative to switching it off at time t3 in variants VI and V2 – with variant V3 essentially being identical to variants VI and V2 from time to time t3. After exceeding the stopper breakaway pressure threshold and displacing the movable stopper 29, the dispensing pressure is held constant for a predetermined constant pressure duration, here until time ts. At time ts, the pressure generating device 21 is switched off. Preferably, the dispensing pressure is held constant until the pharmaceutical substance is completely injected, in particular until the stopper 29 abuts a shoulder of the packaging body 26, thus enabling a comparatively rapid injection.

[0241] Figure 7 shows a schematic, partially enlarged representation of the proximal end 7 of the injection device 1 of Figure 1.

[0242] The injection device 1, in particular the injection body 3, has a status indicator device 75. In particular, the status indicator device 75 has three light-emitting diodes 77 (LEDs) which are designed and configured to indicate at least one state of the injection device 1. In particular, the state is selected from a group consisting of: a charge state of the energy storage device 55 of the injection device 1, a momentary position selected from the connected position and the disconnected position, the pressure medium interface 39, in particular whether the pressure line 23 is pressure-conductingly connected to the primary packaging material 25, and an injection progress, in particular whether the injection is complete, in particular whether the pharmaceutical substance has been completely injected. In particular, a first LED 77.1 of the three LEDs 77 indicates the charge state of the energy storage device 55, a second LED 77.Two of the three LEDs 77 indicate the current position of the print medium interface 39, and a third LED 77.3 indicates the injection progress. Specifically, each of the three LEDs 77 has a shape corresponding to the state it indicates, allowing a user to intuitively recognize which state is meant to be displayed by the respective LED 77. The shape is selected from a group consisting of: a battery shape, a hook shape, and a droplet shape.

[0243] 212220 PCT - KO-HF

Claims

2024-01 43 REQUIREMENTS 1. Injection device (1) for injecting a pharmaceutical substance, comprising: - an injection base body (3) comprising a primary packaging receptacle (19) and a pressure generating device (21) with a pressure line (23), wherein - the primary packaging receptacle (19) is designed and equipped to receive a primary packaging (25), wherein - the pressure line (23) is arranged and designed to connect the pressure generating device (21) to the primary packaging material (25) in a pressure-conducting manner, wherein - the pressure generating device (21) is set up to apply a pressure to a movable plug (29) of the primary packaging (25) limiting a packaging volume of the primary packaging (25) via the pressure line (23) by means of a pressure medium when the primary packaging (25) is received in the primary packaging receptacle (19).

2. Injection device (1) according to claim 1, wherein the pressure generating device (21) comprises a drive device (49) and a compressor device (51), wherein - the compressor device (51) is connected to the pressure line (23) in a pressure-conducting manner, wherein - the drive device (49) is designed and configured to drive the compressor device (51), wherein the compressor device (51) is designed and configured to apply the discharge pressure to the movable plug (29) via the pressure line (23).

3. Injection device (1) according to claim 2, comprising an energy storage device (55) and an electric drive device (50) as the drive device (49), wherein the energy storage device (55) is electrically connected to the electric drive device (50) and is configured to store and release electrical energy for the electric drive device (50), wherein 212220 PCT - KO-HF 2024-01 44 - the electric drive device (50) is designed and set up to apply the discharge pressure to the movable plug (29) by means of the pressure medium.

4. Injection device (1) according to one of the preceding claims, comprising a primary packaging detection device (37), wherein - the primary packaging detection device (37) is designed and configured to detect whether a primary packaging (25) has been received in the primary packaging receptacle (19).

5. Injection device (1) according to one of the preceding claims, comprising a pressure sensor (41), wherein - the pressure sensor (41) is arranged and set up to detect pressure in the pressure line (23).

6. Injection device (1) according to one of the preceding claims, comprising a movable pressure medium interface (39), wherein - the pressure line (23) leads into the pressure medium interface (39), whereby - the pressure medium interface (39) is arranged and set up to be moved between a connected position in which the pressure line (23) is pressure-conductingly connected to the primary packaging material (25) and a disconnected position in which the pressure line (23) is separated from the primary packaging material (25).

7. Injection device (1) according to claim 6, wherein - the pressure medium interface (39) has an expandable sealing element (61) for sealing the pressure medium interface (39) to the primary packaging material (25), wherein - the expandable sealing element (61) is connected to the pressure line (23) in a pressure-conducting manner.

8. Injection device (1) according to claim 7, wherein - the print medium interface (39) is inserted at least section by section into the primary packaging material (25) in the connected position along an insertion direction (65), wherein 212220 PCT - KO-HF 2024-01 45 - the expandable sealing element (61) surrounds an insertion section (63) of the pressure medium interface (39) in a ring shape and is located in the connected position between the insertion section (63) and the primary packaging material (25).

9. Injection device (1) according to claim 7 or 8, wherein - the pressure medium interface (39) has an elastic second sealing element (62) that is different from the expandable sealing element (61) and is arranged and designed such that the second sealing element (62) is pressed against the primary packaging material (25) in the connected position.

10. Injection device (1) according to claim 9, wherein - the second sealing element (62) surrounds the insertion section (63) in a ring shape and is arranged along the insertion direction (65) in front of the expandable sealing element (61).

11. Injection device (1) according to one of the preceding claims, comprising a pressure adjustment device, wherein - the pressure adjustment device is set up to adjust the application pressure.

12. Injection device (1) according to one of the preceding claims, comprising a packaging transfer device (43), wherein - the packaging transfer device (43) is configured to transfer the primary packaging receptacle (19) relative to the injection base body (3) between an injection position and a rest position, wherein - in the injection position, an injection end (35) of the primary packaging (25) protrudes from the injection base body (3) when the primary packaging (25) is received in the primary packaging receptacle (19), wherein - in the rest position the injection end (35) is hidden in the injection base body (3) when the primary packaging (25) is received in the primary packaging receptacle (19).

13. Injection device (1) according to one of the preceding claims, comprising a scraper device (45), wherein 212220 PCT - KO-HF 2024-01 46 - the stripping device (45) is arranged and designed to strip off an injection end protection cap (47) of the injection end (35) for an injection when the primary packaging (25) is received in the primary packaging receptacle (19).

14. Injection device (1) according to one of the preceding claims, wherein the drive device (49) - with the movable pressure medium interface (39) to move it between the connected position and the disconnected position, and / or - with the packaging transfer device (43) to transfer the primary packaging receptacle (19) between the injection position and the rest position, and / or - is connected to the drive mechanism of the stripping device (45) to strip the injection end protection cap (47) of the injection end (35) for injection.

15. Injection device (1) according to any one of the preceding claims, which - has an injection surface detection sensor (13) located at a distal end (5) and configured to detect contact with an injection surface and to automatically generate an injection command, and / or the - has an injection button (12) that is set up to manually generate an injection command.

16. Injection device (1) according to one of the preceding claims, comprising a control device (59) which - with the pressure generating device (21), and / or - with the primary packaging detection device (37), and / or - with the pressure sensor (41), and / or - with the print medium interface (39), and / or - with the pressure adjustment device, and / or - with the packaging transfer device (43), and / or - with the scraper device (45), and / or - with the injection surface detection sensor (13), and / or - is connected to the injection button (12) for control purposes, in order to perform an injection upon the injection command. 212220 PCT - KO-HF 2024-01 47 17. Control method for an injection device (1) for injecting a pharmaceutical substance from a primary packaging material (25), wherein the primary packaging material (25) comprises a packaging material base body (26), a movable stopper (29) and an injection end (35), wherein the packaging material base body (26) together with the movable stopper (29) defines a packaging material volume in which the pharmaceutical substance is contained, wherein the stopper (29) is movable such that the pharmaceutical substance can be dispensed from the packaging material volume by means of the injection end (35), wherein in the method - the movable plug (29) is subjected to a dispensing pressure by means of a pressure medium, so that the movable plug (29) moves and the pharmaceutical substance is dispensed from the primary packaging material (25).

18. Control method according to claim 17, wherein - the movable plug (29) is subjected to an initial dispensing pressure by means of the pressure medium, which is less than a plug breakaway pressure threshold value, upon exceeding which the movable plug (29) moves, wherein - the application pressure is increased from the initial application pressure until the plugless breakout pressure threshold is exceeded and the movable plug (29) is displaced.

19. Control method according to claim 18, wherein - the application pressure is increased at least once more after exceeding the plugless breakout pressure threshold and moving the movable plug (29).

20. Control method according to claim 18 or 19, wherein - after exceeding the plugless breakaway pressure threshold and moving the movable plug (29), the discharge pressure is kept constant for a predetermined constant pressure period.

21. Control method according to one of claims 18 to 20, wherein - the application pressure is gradually increased from the initial application pressure by at least one application pressure increase step, whereby 212220 PCT - KO-HF 2024-01 48 - after increasing the application pressure by one step, it is checked whether the movable plug (29) is moved.

22. Control method according to one of claims 17 to 21, wherein - before applying the pressure medium to the movable plug (29) with the dispensing pressure, a leak test is carried out, checking whether the pressure generating device (21) and the primary packaging material (25) are connected to each other in a pressure-conducting manner without leakage.

23. Control method according to claim 22, wherein - the leak test is carried out by applying a pressure to the movable plug (29) using the pressure medium at a pressure increased to a leak test pressure value, wherein the leak test pressure value is less than the plug breakaway pressure threshold value, whereby it is checked whether the pressure increased to the leak test pressure value remains constant, wherein a falling pressure is concluded that the pressure generating device (21) and the primary packaging material (25) are not leak-free and pressure-conductingly connected to each other.

24. Control method according to one of claims 17 to 23, wherein - an injection device (1) according to one of claims 1 to 16 is operated by the control method. 212220 PCT - KO-HF

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