EA046799B1 - DEVICE FOR INTRODUCING FLUID - Google Patents

Abstract

A device for introducing a fluid into the vitreous body of the eye is described, comprising: a first driving part that can rotate for axial movement of the main unit acting on the plug by means of a lead screw; a drive spring that can be partially released by actuating the first driving part and, at least partially, can be released by actuating the second driving part of the device for introduction; an actuator comprising a locking element that locks the main unit in the axial direction, both in the insertion position and in the final position of the main unit, and/or an indicator part that can rotate under the action of the axially moving main unit

Description

The invention relates to a device for introducing a fluid, preferably for use in ophthalmology, in particular for introducing a fluid into the vitreous body of the eye.

The invention relates generally to the field of injection devices for introducing/delivering a pharmaceutical fluid, in particular a drug, into the body of a patient, human or animal.

The administration device of the present invention is preferably intended for delivery, in particular for injection of a drug (directly) into the eye, in particular into the vitreous, anterior and/or posterior chambers of the eye, human or animal. Thus, the present invention relates in particular to injection devices for the administration/delivery of a fluid in ophthalmology, in particular for the injection of a fluid, in particular a drug, into the vitreous body of the eye. However, the administration device of the present invention can also be used to administer/deliver a fluid, in particular a drug, to other parts of the human or animal body.

WO 2014/005728 A1 relates to a small volume syringe suitable for ophthalmic injection, the syringe being pre-filled with a medicinal product and including a body, a piston plug and a rod. The syringe rod is provided with a contact surface configured to contact the stopper so that the rod can be used to advance the stopper toward the outlet of the syringe, resulting in delivery of fluid contained in the syringe.

Document US 2006/0069350 A1 relates to a medical syringe pen with a housing in which the syringe is located. The handle is provided with a drive mechanism and a drive member for releasing the drive mechanism and driving the device to deliver fluid from the syringe to the user.

Document US 2010/0231102 A1 relates to a device for intravitreal injections of the eye, including an injection unit designed to contain a syringe. The injection unit is adapted to automatically deliver a syringe to a patient's eye for injection of a fluid contained in the syringe.

It is an object of the present invention to provide an improved, in particular fully mechanical, insertion/delivery device that is convenient and/or easy to use, intuitive and/or safe to use, and/or minimizes or at least reduces the risk of misuse, contamination, erroneous and/or imprecise dosing, and/or introduction/delivery of air bubbles, and/or minimizing or reducing the requirements and/or complexity of the manufacturing process of such a device.

The above goal is achieved using a device for introducing a fluid according to claim 1 of the formula. Other preferred embodiments are the subject of dependent claims.

The administration/delivery device, hereinafter referred to as an administration device, according to the present invention is preferably designed to (fixedly) hold a generally cylindrical container for a fluid and/or containing a fluid, in particular a drug. The administration device preferably comprises a container and/or a plunger/piston/plug movably mounted within the container, in particular such that upon axial movement of the plunger/piston/plug (hereinafter referred to as a plug) towards the outlet of the container, fluid is released contained in the container.

In addition, the insertion device comprises a frame/body (hereinafter referred to as frame), wherein preferably the container is held or can be held motionless by the frame and/or is at least partially housed within the frame.

The insertion device comprises an actuator mechanism for actuating the insertion device and/or for moving the stopper within the container, in particular for so-called initialization of the insertion device before injecting fluid and/or dispensing fluid from the container, as this will be described below.

The insertion device, in particular its actuator, comprises a main unit acting on the plug, in particular directly and/or in the axial direction, preferably a pre-stressed/compressed drive spring acting on the main unit, in particular directly and/or in the axial direction , a first drive portion and a second drive portion, wherein these portions are movably attached to the frame, and/or the main assembly is particularly movable in an axial direction relative to and/or located in the frame, and/or the main assembly is movable in an axial direction relative to the frame by activating the first drive part and/or the second drive part, in particular to initialize the device for introducing and/or dispensing fluid from the container.

The insertion device actuator is preferably configured to (axially) move the main assembly, plug and/or drive spring from an initial position (device not engaged) to an insertion/ready-for-use position (device initialized) during the initialization process, before injection and/or by activation of the first drive part, and/or from the insertion/ready-for-use position (initialization device

- 1 046799 rovanny) to the end position (device triggered, end of use) after initialization, in the (subsequent) injection process and/or by at least partially releasing the drive spring and/or by actuating the second drive part.

In accordance with one aspect of the present invention, the insertion device, in particular the actuator, comprises a lead screw, wherein the first drive part and the main assembly can (directly) movably interact with each other and/or can be connected (directly) to each other another moveable by means of a lead screw, and/or the first drive part can be rotated (manually), in particular relative to the frame and/or container, to axially move the main assembly, in particular relative to the frame and/or container, so that rotation is preferable the first drive part causes the main assembly and/or the (compressed) drive spring to move axially towards the plug and/or from the initial position (device not engaged) to the insertion/ready for use position (device initialized).

In preferred embodiments, the first driving part forms the axial end and/or the (rotational) cap of the insertion device, which can be actuated manually, in particular by rotation, to move the main assembly in the axial direction.

By actuating, in particular by rotating, the first driving part and accordingly moving the main assembly, the plug and the driving spring, it is possible, at least partially manually, to initiate the insertion device and/or to expel the air/gas contained in the container and/or in a needle attached to it.

This ensures simple, intuitive and convenient initialization of the insertion device.

In the context of the present invention, the term initiate/initialize preferably refers to the (necessary) preparation of the injection device (immediately) before injection of the fluid contained in the injection device, in particular in its container.

In preferred embodiments, during the initialization process, the main assembly is moved (axially) in such a manner and/or until the main assembly, in particular its rod/connecting rod, abuts the plug.

In the most preferred embodiments, the main assembly is moved (axially) in such a way that it, in particular its rod/connecting rod, moves/pushes the plug, in particular in the direction of the outlet, and/or in such a way that a (small) part of the fluid is released and /or air, that is, air bubbles contained in the fluid, in the container and/or in the needle attached thereto, are removed, in particular pushed out.

In preferred embodiments, the insertion device is held in a vertical position during the initialization process so that the outlet of the container and/or the needle attached thereto is directed upward and air can be at least partially pushed out of the container.

In preferred embodiments, the volume of fluid contained in the container after initialization corresponds to the required/predetermined dose to be administered to the patient/user.

Typically, the volume of fluid contained in the (prefilled) container exceeds the volume of the dose to be administered, so that air contained in the fluid, in the container and/or in the needle attached thereto can be removed at least partially during the initialization process without adversely affecting the dose to be injected.

However, initialization of the injection device does not mean that the container is actually filled with fluid and/or that a portion of that fluid is released. In particular, the actuator, most preferably the first drive part, can also be actuated even when the container is empty and/or without moving and/or affecting the stopper.

In other words, initialization specifically means the movement of the main assembly, plug and/or drive spring from the initial position (device not engaged) to a certain position, which is referred to below as the insertion/ready for use position (device initialized), in particular before injection of fluid , and/or by driving the first drive part.

Accordingly, all actions performed before injection of fluid and/or before activation of the second drive part should be considered as initialization and/or initialization process.

In preferred embodiments, the initialization is/is performed solely (entirely) by actuating, in particular by rotating, the first drive part.

In the context of the present invention, the term administration/administration preferably refers to the (actual) delivery/dispensing of fluid from the administration device, preferably from its container, most preferably through an injection needle attached thereto.

Although in preferred embodiments, the administration device of the present invention is used to administer a fluid, in particular a drug, directly into the patient's body, for example, using an injection needle and/or by injecting the fluid directly

- 2 046799 intravenously into the patient's eye, in particular into the vitreous body of the eye, the term introduction/administration also refers to the delivery/delivery of the fluid without the patient.

Preferably, insertion/insertion means and/or includes movement of the main assembly and/or plug from the insertion/ready-for-use position (device initialized) to the final position (device triggered, end of use), in particular after initialization and/or after (full) insertion into action of the first driving part.

The home position (device not engaged), hereinafter referred to as the home position, is preferably the (axial) position of the main assembly, plug and/or drive spring relative to the frame and/or container before initializing the insertion device and/or before actuating the first drive parts, and/or in the original state of the insertion device.

In the initial state of the insertion device, and/or when the main assembly, plug and/or drive spring are/are in the initial position, the first drive part and the second drive part are not activated, and/or the drive spring is tensioned (to the greatest extent).

In preferred embodiments, it is not possible to (directly) actuate the second drive part and/or (directly) inject fluid in the initial state of the injection device, and/or when the main assembly, plug and/or drive spring are/are in the initial position. The main assembly, plug and/or drive spring can be moved from the rest position and/or from the rest position to the insertion/ready-for-use position (device initialized), in particular solely by actuating the first drive part.

The insertion/ready-to-use position (device initialized), hereinafter referred to as the insertion position, is preferably the (axial) position of the main assembly, plug and/or drive spring relative to the frame and/or container (immediately) after initialization and/or (immediately g) after (completed) activation, in particular by rotation, of the first driving part and/or (immediately) before the injection, and/or in the state of insertion/ready for use (device initialized) of the injection device, hereinafter referred to as the state of insertion .

In the insertion state of the insertion device, and/or when the main assembly, plug and/or drive spring are/are in the insertion position, the first driving part is (fully) driven, and the second driving part is (not yet) driven.

In the insertion state/position, the main assembly, plug and/or drive spring are/are closer to the outlet of the insertion device, in particular the container, and/or further from the first driving part compared to the initial state/position. In particular, the main assembly and/or plug is inserted/entered further into the container in the insertion state/position compared to the initial state/position.

In the insertion state of the insertion device, and/or when the main assembly, plug and/or drive spring are/are in the insertion position, the main assembly, in particular its rod/connecting rod, abuts the plug, and/or the insertion device is ready for use, the second drive part can be (directly) driven and/or the fluid can be administered to the patient without performing other steps than driving the second drive part.

In preferred embodiments, the first driving part cannot be (again) activated and/or deactivated in the insertion state/position.

Completion/device actuation/end of use, hereinafter referred to as the end position, preferably represents the (axial) position of the main assembly and/or plug relative to the frame and/or container (immediately) after injection, and/or after (full) actuation of the second actuator parts, and/or in the end state/device triggered/end of use of the insertion device, hereinafter referred to as the end state.

In the final state of the injection device, and/or when the main assembly and/or plug are/are in the final position, fluid is injected, the second drive part is (fully) actuated, and/or the drive spring is at least partially released/released. elastic spring force/spring energy.

In the final state/position, the main assembly and/or plug are/are closer to the outlet of the insertion device and/or further from the first driving part, compared to the initial state/position and/or the insertion state/position (fluid).

In preferred embodiments, the main assembly and/or plug is inserted/introduced further into the container in a final state/position compared to the initial state/position and/or insertion state/position.

Specifically, the drive spring is less stressed in the end state/position compared to the insertion state/position and/or the end state/position.

However, in preferred embodiments, to ensure dose accuracy, the drive spring is all

- 3 046799 is still tense, in particular compressed, in its final state/position.

In particular, fluid is no longer dispensed/injected in the end state and/or after reaching the end position.

In preferred embodiments, the first drive part cannot be (again) activated and/or deactivated in the end state and/or after reaching the end position.

As already indicated, in preferred embodiments, the first drive part is actuated (manually) by rotating it relative to the frame and/or container, most preferably about and/or at least substantially transversely/perpendicular to the main axis of the administration device and/or the direction of injection .

In preferred embodiments, the second drive portion is actuated (manually) by pressing against the frame and/or container, most preferably around and/or at least substantially transverse/perpendicular to the main axis of the administration device and/or the direction of injection. In this way, the possible negative impact of the actuation of the first drive part and/or the second drive part on the injection side is minimized or at least reduced.

According to another aspect of the present invention, which can also be implemented independently, the drive spring/spring force/spring energy of the actuator can be at least partially decompressed/released, in particular by rotation of the first drive part and/or in a process, in particular by end, initialization and/or before injection, and at least partially (additionally) released by actuation, in particular by pressing, of the second drive part and/or after initialization and/or during the injection process.

In other words, the first drive part is configured to at least partially decompress, in particular release, the drive spring/spring force/spring energy in the first step, and the second drive part is configured to at least partially (further) decompress, in particular release, drive spring/spring force/spring energy in the second/subsequent step, wherein preferably the second drive part can only be actuated after the first drive part has been (fully) actuated and/or in the insertion state of the insertion device and/or in the insertion position of the main node and/or plug.

In preferred embodiments, the first drive part is configured to move the main assembly, the plug and/or the drive spring, in particular together with each other and/or as an integral part, from the rest position to the release/release position, in which the drive spring/spring force/ the energy of the spring is at least partially released/released so that further/subsequent movement of the main assembly and/or plug is supported and/or completed by the drive spring, in particular due to its elastic force, and/or so that the main assembly and/or the plug is/is moved further/then from the release position to the insertion position, in particular automatically and/or solely under the action of the drive spring, in particular under the action of its elastic force.

In other words, the main assembly, plug and/or drive spring is first moved/moved in the first step and/or from the initial position to the release/release position manually and/or (solely) by actuating, in particular by rotation, the first driving part and are then moved/moved in a second step and/or from the release/release position to the insertion position automatically, and/or, in particular, exclusively by partial release of the drive spring, that is, due to the elastic force/energy of the drive spring. In particular, the initialization and/or termination of the initialization process is preferably carried out exclusively by the drive spring, that is, under the action of the elastic force of the spring.

The release/release position, hereinafter referred to as the release position, is preferably an (axial) position of the main assembly, plug and/or drive spring relative to the frame and/or container during the initialization process and/or between the initial position and the insertion position and/or (directly ) before reaching the insertion position, injection state and/or completion of initialization.

In the release position, and/or during the initialization process and/or (immediately) before reaching the insertion position, the drive spring/spring force/spring energy is (automatically) at least partially released/released, in particular in such a way that subsequent movement of the main assembly and/or the plugs to the insertion position, and/or the transition of the insertion device from the initial state to the insertion state is completed and/or supported by the drive spring.

Thus, in accordance with one aspect of the invention, the initialization and/or movement of the main assembly and/or plug during the initialization process and/or from the initial position to the insertion position is performed half manually/half automatically and/or manually in both cases, that is, by actuation, in particular by rotation, of the first drive part and automatically, that is, by at least partially decompressing/releasing the drive spring/its elastic force

- 4 046799 ly.

In preferred embodiments, the drive spring/spring force/spring energy is at least partially decompressed/released and/or the drive spring is less compressed in the insertion state, and/or when the main assembly, plug and/or drive spring are in the insertion position, according to compared to the original state, and/or when the main assembly, plug and/or drive spring are in the original position.

The advantages of half-manual/half-automatic initialization include increased usability of the inserter and improved control of the initialization process compared to fully automatic initialization.

The drive spring, in particular its elastic force, ensures the transition from the initial state to the insertion state of the insertion device. In addition, the decompression/release of the drive spring/spring force/spring energy during the initialization process clearly indicates to the user/practitioner that the manual portion of the initialization process has been completed correctly.

In addition, the critical components, namely, the components that mechanically interact with each other during the insertion process, are already moved/pushed into the desired position during the initialization process by the drive spring, so that the shock effect caused by the decompression/release of the drive spring/spring force /spring energy, first occurs (less critically) during the initialization process and before (more critically) fluid injection. Thus, the risk of incorrect and/or inaccurate dosing is reduced and the negative impact of geometric deviations during the administration process is reduced.

According to another aspect of the present invention, which can also be implemented independently, the first drive part can be driven to move, in particular in the axial direction, the main assembly, the plug and/or the drive spring, in particular together with each other and/ or integrally, from the release position to the release position, wherein the actuator preferably includes a locking element configured to prevent decompression/release of the drive spring/spring force/spring energy when the main assembly and/or drive spring is moved from the release position to the release position and for at least partially decompressing/releasing the drive spring/spring force/spring energy, in particular automatically, in the release position and/or upon reaching the release position, preferably such that the insertion position is reached automatically and/or exclusively by means of the drive spring, namely due to its elastic force, and/or without additional actuation of the first drive part, as has already been described.

In this way, corresponding advantages and benefits can be ensured.

In preferred embodiments, the first drive part comprises or forms a locking element, which is in particular in the form of an internal screw thread engaged with the main assembly, in particular an end part thereof, and/or the locking element can be disengaged by actuation , in particular by rotation, of the first driving part.

According to another aspect of the present invention, which can also be implemented independently, the second drive part can be actuated, in particular by pressing, to at least partially (further) decompress/release the drive spring/spring force/spring energy and/ or moving the main assembly and/or plug from the insertion position to the final position, the actuator, in particular the second driving part, comprising a locking element configured to axially lock the main assembly, in particular to move it in an axial direction, in the insertion position, that is , before actuation of the second drive part, as well as in the final position, that is, after actuation of the second drive part.

In other words, the blocking element/part stops the axial movement of the main unit and/or plug at the end of the initialization and, subsequently, at the end of the injection process.

In preferred embodiments, the locking element/part is configured to axially lock the main assembly (only) after at least partially decompressing/releasing the drive spring/spring force/spring energy by the first drive part and/or upon reaching the insertion position, in the position introduction of the insertion device and/or after completion of the initialization process and/or after at least partial decompression/release of the drive spring/spring force/spring energy by the second drive part, and/or upon reaching the end position, in the end state of the device for administration and/or after completion of the administration (injection) process. However, in the initial state of the insertion device and/or in the initial position of the main assembly and/or plug, the locking element/part preferably does not axially block or engage the main assembly.

Using the (same) blocking element to determine the end of processes

- 5 046799 initialization and injection increases dosing accuracy and, accordingly, minimizes the requirements for product manufacturing technology.

The main assembly, in particular its rod, preferably includes a first stopper and a second stopper, wherein preferably the first stopper and the second stopper are axially offset relative to each other, and/or the locking element is designed to axially engage the first stopper in the position/state of insertion and/or after completion of the initialization process, and/or (the same) locking element is designed to axially engage with the second stopper in the final position/state and/or after completion of the injection process.

According to another aspect of the present invention, which can also be implemented independently, the insertion device includes an indicator portion indicating the state of the insertion device and/or the (axial) position of the main assembly and/or plug relative to the frame and/or container, wherein the indicator portion can be rotated, in particular driven into rotation, by (directly) (axial) movement of the main assembly, preferably only after the initialization process and/or upon reaching the injection position, preferably only after the initialization process and/or upon reaching the insertion position and/or only when moving the main unit from the insertion position to the end position.

In this way, a simple and reliable (visual) indication of the status of the inserter and/or the axial position of the main assembly and/or plug is provided, thereby reducing the risk of misuse of the inserter due to possible misunderstanding of the status of the device.

In preferred embodiments, the indicator part is made in the form of a hollow cylinder and/or sleeve, which is preferably located inside the frame with the possibility of rotation.

In preferred embodiments, the main assembly extends axially through the indicator portion, and/or the indicator portion (radially) surrounds/encloses the main assembly, in particular the intermediate portion thereof.

In preferred embodiments, the indicator part is designed to indicate the initial position, the release position, the insertion position and/or the final position of the main assembly and/or plug, and/or the initial state, the insertion state and/or the final state of the insertion device, in particular by means of its angular position relative to the main assembly, container, stopper and/or frame.

For rotating the indicator part, the main assembly, in particular the intermediate part thereof, preferably includes at least one protrusion, such as a radially directed pin, the protrusion/pin preferably engaging and/or engaging with the spiral or inclined slot and/or the surface of the indicator part into engagement, in particular in such a way that the axial movement of the main unit leads to rotation of the indicator part. This ensures a simple mechanical connection between the main unit and the indicator part.

In addition, the protrusion/pin and/or indicating means of the main assembly may be visible from the outside of the insertion device, indicating the state of the insertion device and/or the axial position of the main assembly and/or plug, in particular the initial position, the release position, the insertion position and/or an end position, most preferably in addition to the indicator part.

In most preferred embodiments, the protrusion/pin and/or indicating means are configured to indicate the state of the insertion device and/or the axial position of the main assembly and/or plug during initialization, and the indicator portion is configured to indicate the state of the insertion device and/or the axial position of the main assembly. node and/or plug during insertion.

This improves usability and reduces the risk of incorrect operation due to possible misunderstanding of the insertion device status.

In addition, the indicator portion is designed to limit visibility of the interior portions of the insertion device and to focus the user/practitioner's attention on the indicator portion and/or the pin, at least during the initialization process.

Another aspect of the present invention relates to a method of using an administration device, the method comprising at least one of the following steps:

Rotation (manually) of the first drive part, which results in axial movement of the main assembly, plug and/or drive spring relative to the frame and/or container, preferably together with each other and/or as a whole, in particular by means of an actuator lead screw, and/or

Actuation (manually), in particular by rotation, of the first drive part, which leads to at least partial decompression/release of the drive spring/spring force/spring energy, in particular in the release position of the main assembly and/or upon reaching the release position, and then actuating (manually), in particular by pressing, the second driving part, which leads to at least partial (additional) release

- 6 046799 tension/release of the drive spring/spring force/spring energy, in particular in the insertion position of the main unit, and/or

Actuation (manually), in particular by rotation, of the first drive part, which causes (axial) movement of the main assembly, plug and/or drive spring, preferably together with each other and/or as a whole, from the rest position to the release position , in which the drive spring/spring force/spring energy, in particular automatically, is partially expanded/released, and/or

Actuation (manually), in particular by pressing, of the second drive part, which leads to at least partial decompression/release of the drive spring/spring force/spring energy, which then moves, in particular pushes, the main assembly and/or plug from an insertion position into an end position in which the main assembly is locked axially by a locking element of the actuator, both in the insertion position and/or before actuation of the second drive part, and in the end position, and/or after actuation of the second drive part, and/ or

Rotation of the indicator part of the insertion device by (axial) movement of the main assembly, in particular its pin.

In this way, corresponding advantages and benefits can be ensured.

The above-described aspects and features of the present invention, as well as the aspects and features of the present invention that will be apparent from the claims and the following description, can in principle be implemented independently of each other, as well as in any combinations or in any order.

Other aspects, advantages, features and properties of the present invention will become apparent from the claims and from the following description of a preferred embodiment of the invention with reference to the drawings, in which:

in fig. 1 is a schematic perspective view of the proposed insertion device;

in fig. 2 is a schematic perspective view of an insertion device without a casing, the first driving part being transparent;

in fig. 3 - disassembled view of the insertion device;

in fig. 4 is an exploded view of the insertion device, rotated 90° about its major axis, compared to FIG. 3;

in fig. 5 is a schematic longitudinal sectional view of the insertion device in its initial position/state;

in fig. 6 is a schematic longitudinal sectional view of the insertion device in its initial position/state, rotated 90° about its main axis, compared to FIG. 5;

in fig. 7 is a schematic longitudinal sectional view of the insertion device in its release position/state;

in fig. 8 is a schematic longitudinal sectional view of the insertion device in its release position/state rotated 90° about its main axis, compared with FIG. 7;

in fig. 9 is a schematic longitudinal sectional view of the insertion device in an insertion position/state;

in fig. 10 is a schematic longitudinal sectional view of the insertion device in an insertion position/state rotated 90° about its main axis, compared with FIG. 9;

in fig. 11 is a schematic longitudinal sectional view of the insertion device in its final position/state;

in fig. 12 is a schematic longitudinal sectional view of the insertion device in a final position/state rotated 90° about its major axis, compared to FIG. eleven;

in fig. 13 is a partial cross-sectional perspective view of the insertion device in its initial state/position;

in fig. 14 is a partial cross-sectional perspective view of the insertion device in an insertion state/position;

in fig. 15 is a partial cross-sectional perspective view of the insertion device in its final state/position.

The same reference numerals are used to indicate the same or similar parts and components in the figures, resulting in corresponding comparable properties, features and advantages, even if those properties, features and advantages are not repeatedly described. The structure and components/parts of the proposed insertion device 100 will be described below with reference to FIGS. 1-4. The interaction of the components/parts and the use of the administration device 100 will be described with reference to FIGS. 5-15, with some reference symbols omitted from these figures (for simplicity) although corresponding features/components/parts are shown therein.

In fig. 1 is a schematic perspective view of the proposed insertion device 100 in its original state. Fig. 2 corresponds to Fig. 1, with some components of the device 100 for

- 7 046799 insertions are closed and shown transparent to illustrate the internal components of the insertion device 100. In fig. 3 and fig. 4 shows views of the insertion device 100 in an disassembled state/position at different angles.

The insertion device 100 is a multi-part structure and/or contains multiple parts/components, with preferably some or all of the portions of the insertion device 100 being connected to each other using a snap/clamp connection and/or without the use of screws.

The terms snap-on, clamp-on and/or snap-on/clamp connection are preferably understood as an assembly/connection method in which at least two parts/two components are assembled/connected to each other, in particular by means of a tight fit, using the elasticity/resilience of the assembled/ parts/components to be connected and/or without the use of (additional) fastening elements such as pins, screws, bolts, etc.

As this is best seen in FIG. 3 and fig. 4, the insertion device 100 preferably includes a container 10, a frame 20, a housing 30, an indicator portion 40, and an actuator with a main assembly 50, preferably a compressed/prestressed drive spring 60, a first drive portion 70, a second drive portion 80, and/or optionally initiating device 90.

Preferably, some or all of the parts/components of the insertion device 100, such as the container 10, frame 20, housing 30, indicator portion 40 and actuator, main assembly 50, first drive portion 70, second drive portion 80, and/or optional initiating device 90 made, in particular by injection molding, from plastics, most preferably from polyethylene and/or polypropylene. The insertion device 100 is preferably elongated and/or rod/handle shaped. In particular, the administration device 100 is configured as a hand-held device and/or is shaped such that it fits comfortably in the hand of a user/practitioner.

The insertion device 100, in particular the container 10, the housing 30, the indicator part 40, the drive spring 60 and/or the first drive part 70 preferably has at least an overall cylindrical and/or axisymmetric shape.

Preferably, the insertion device 100, in particular the container 10, has/forms a major axis A, this axis being a central, longitudinal axis of symmetry and/or rotation of the insertion device 100, in particular the container 10, and the major axis A extends centrally through the insertion device 100 administration, in particular through the container 10, the frame 20, the casing 30, the indicator part 40, the main unit 50, the drive spring 60, the first drive part 70 and/or the needle 19 (not shown in Fig. 1-4) attached to the injection device 100.

In the following description, the spatial arrangement of parts, in particular the indications radial or radial, and/or axial or axial, refers to the main axis A of the introduction device 100, in particular the container 10, unless expressly indicated otherwise.

The first drive portion 70 forms the (first) axial end and/or the rear end, and/or the container 10, in particular its tip/outlet, forms the (second) axial end and/or the front end of the insertion device 100.

In the normal use position of the administration device 100, the container 10 preferably faces away from the user/practitioner and/or toward the patient, and the first drive portion 70 faces toward the user/practitioner and/or away from the patient.

The housing 30 has at least a substantially cylindrical shape and/or is a hollow cylinder, in particular having an inner and/or outer diameter that varies along a major axis A.

The housing 30 preferably encloses/covers some or all portions/components of the insertion device 100 radially/laterally and/or externally. Preferably, the housing 30 encloses/encloses the container 10, the frame 20, the indicator portion 40, the main assembly 50, the drive spring 60, the first drive portion 70, the second drive portion 80 and/or the initiating device 90, at least partially or completely, radially/laterally and/or outside.

In the exemplary embodiment, the housing 30 partially encloses/radially/laterally encloses the container 10, the first drive portion 70, and/or the second drive portion 80, and the housing 30 completely encloses/encloses the frame 20, the indicator portion 40, the main assembly 50, the drive spring 60, and/or or initiating device 90, radially/laterally and/or externally.

Most preferably, the first drive portion 70 and/or container 10 extends axially from the housing 30 and/or the second drive portion 80 extends radially from the housing 30.

Preferably, the housing 30 is a multi-part structure. In particular, the casing 30 includes a first casing part 31 and a second casing part 32, and preferably the first casing part 31 and the second casing part 32 are configured as halves of the casing, and/or the first casing part 31 and the second casing part 32 are connected to each other using snap/clamp connection.

- 8 046799

In preferred embodiments, the housing 30 is open in the axial direction. In particular, the housing 30 has a first axial opening 33 and a second axial opening 34, with preferably a first drive portion 70 protruding from the first axial opening 33 and/or a container 10 protruding from the second axial opening 34. Most preferably, the first axial opening 33 is larger second axial hole 34.

In addition, the housing 30, in particular the second housing portion 32, preferably has a radial opening 35 and/or a housing window 36, wherein preferably a second driving portion 80 and/or an interior portion of the insertion device 100 protrudes from the radial opening 35, in In particular, the indicator portion 40 is at least partially visible through the housing window 36.

As already indicated in the previous part, the administration device 100 is intended for injecting/supplying a fluid 11, in particular a drug, to a patient, that is, a human or an animal. Preferably, container 10 is pre-filled with fluid 11 and/or already contains fluid 11 in the initial state of administration device 100.

The administration device 100 is preferably designed to inject/supply fluid 11 from the container 10, in particular from its outlet, to the patient, most preferably through its actuator, as will be described below in more detail.

The container 10 is preferably formed as one piece/one piece. Most preferably, the container 10 is made of glass or injection molded plastic.

The container 10 preferably has an elongated shape and/or is shaped like a hollow cylinder.

In preferred embodiments, the container 10 includes a main body 12, preferably in the shape of a hollow cylinder, and/or the internal diameter of the main body 12 is constant in its longitudinal direction.

In preferred embodiments, the container 10 has a first axial end 13 and a second axial end 14, wherein the first axial end 13 is in the form of a flange/shoulder and/or its outer diameter is larger than the outer diameter of the main body 12 and/or the second axial end 14.

In preferred embodiments, the second axial end 14 is configured as the tip of the container 10 and/or includes or forms the outlet of the container 10.

In particular, the second axial end 14 of the container 10 has a conical shape and/or tapers towards an end. In the most preferred embodiment, the inner and/or outer diameter of the second axial end 14 is smaller than the inner and/or outer diameter of the main body 12 and/or the first axial end 13.

In preferred embodiments, the second axial end 14 of the container 10 is configured as a connecting part for the needle 19 (not shown in FIGS. 1-4).

As shown in FIG. 1 and fig. 2, the insertion device 100, in particular the container 10, is optionally provided with a closing/locking portion 15, in particular a luer lock, to protect/seal the insertion device 100, in particular the container 10, most preferably at its second axial end 14, and/or to provide a connection to the needle 19. In preferred embodiments, the needle 19 may be attached to the container 10, in particular to the second axial end 14, by a locking portion 15, most preferably using a tight fit of the connecting parts.

In preferred embodiments, the locking portion 15 includes a connector 16 and/or a cap 17, wherein the connector 16 and/or cap 17 is preferably attached to the second axial end 14 of the container 10, particularly using a press fit, and the cap 17 axially closes the second axial end 14 and /or connector 16, which is most preferably in the initial state of the device 100 for introduction.

The connector 16 is preferably designed to connect the needle 19 to the container 10, in particular to its second axial end 14.

To connect the needle 19 to the container 10, the cap 17 can be removed from the container 10 and/or connector 16. The needle 19 can then be attached to the connector 16.

In preferred embodiments, the locking part 15, in particular the connector 16, has an internal thread so that the needle 19 can be screwed into the locking part 15, in particular into the connector 16. In this way, a particularly secure connection between the needle 19 and the locking part 15 can be ensured. However, other design solutions are also possible.

The administration device 100, in particular the container 10, preferably includes a plug 18, the plug 18 being preferably movably mounted within the container 10, in particular within its main body.

In preferred embodiments, the main body 12 of the container 10 and the plug 18 form the fluid chamber 11.

The plug 18 is preferably made, in particular by injection molding, from a plastic material, in particular from an elastomer.

The plug 18 preferably has a cylindrical shape and/or an outer diameter corresponding

- 9 046799 being at least substantially the inner diameter of the container 10, in particular the main body 12, and/or (slightly) larger than it, so that the stopper 18 is pressed tightly against the inner wall of the container 10. In preferred embodiments, the stopper 18 is pressed tightly against the inner wall of the container 10, in particular the main body 12, and/or contains or forms at least one (radial) sealing element, in particular such that the fluid 11 cannot leak and/or penetrate the gap between the plug 18 and the inner wall of the main buildings 12.

By moving/pushing the plug 18 towards the second axial end 14 of the container 10, in particular through an actuator, it is possible to reduce the volume of the chamber formed by the main body 12 and the plug 18, thereby discharging the fluid contained in the container 10.

As already indicated, the insertion device 100 preferably includes a frame 20, with some or all parts/components of the insertion device 100 preferably (directly) mounted on and/or in the frame 20, in particular rigidly/fixedly or movably attached to this frame and /or held by him.

Thus, the frame 20 preferably serves as a support/connection/mounting structure for other parts/components of the insertion device 100, in particular the container 10, the housing 30, the indicator part 40, the main assembly 50, the first drive part 70, the second drive part 80 and/or initiating device 90.

In preferred embodiments, container 10 and/or casing 30 is rigidly/immovably supported by and/or attached to frame 20.

In preferred embodiments, the indicator portion 40, the main assembly 50, the first drive portion 70, the second drive portion 80, and/or the initiating device 90 are movably attached to the frame 20 and/or movably positioned within the frame, as will be described below in more detail.

The frame 20 preferably includes a mounting portion 21, preferably open radially/sideways, for the container 10 and/or the second drive portion 80 and a frame 22, preferably open axially, for the indicator portion 40, the main assembly 50, the first drive portion 70 and/or the initiating device 90.

The mounting part 21 and the frame 22 are preferably made of the same material and/or formed, in particular by injection molding, as one piece. The frame 20, in particular the mounting part 21, is preferably designed to hold the container 10 in a stationary position, preferably using a clamp connection, and/or in particular in such a way that the container 10 is held in radial and axial directions within the frame 20, in particular within the mounting part 21, and/or by means of this frame.

In preferred embodiments, the container 10 is inserted radially/laterally, particularly using a press fit/clamp connection, into the frame 20, most preferably into the mounting portion 21.

For this purpose, the internal shape/contour of the mounting portion 21 preferably matches at least substantially the external shape/contour of the container 10.

In preferred embodiments, the mounting part 21 includes in particular a slot-shaped socket 21A for the first axial end 13 of the container 10 and/or a retainer 21B, preferably in the form of a half-shell, for the main body 12 of the container 10.

In the most preferred embodiments, the first axial end 13 of the container 10 is inserted (radially), particularly using a press fit/clamp connection, into the seat 21A, and/or the main body 12 is inserted (radially), particularly using a press fit/clip connection, into the retainer 21B, in particular in such a way that the container 10 is held in a stationary position by the frame 20, in particular by the mounting part 21.

In preferred embodiments, the frame 20, in particular the frame 22, is configured to receive (axially) and/or support (radially) an indicator portion 40, a main assembly 50, a first drive portion 70, a second drive portion 80, and/or an initiating device. 90, in particular in such a way that the indicator part 40 and/or the second driving part 70 can be rotated relative to the frame 20 and/or held in the axial direction by the frame 20, in particular by the frame 22, and/or such that the main assembly 50 and/ or the initiating device 90 can be rotated axially relative to the frame 20 and/or within the frame 20, in particular within the frame 22, as will be described below.

In preferred embodiments, the indicator portion 40, the main assembly 50, the first driving portion 70, and/or the initiating device 90 are inserted axially into the frame 20, most preferably into the frame 22. In preferred embodiments, the indicator portion 40, the main assembly 50, and/or the initiating device 90 is inserted completely and/or the first drive part 70 is inserted partially inside the frame 20, most preferably inside the frame 22.

The frame 20, in particular the frame 22, preferably includes, in particular, an at least substantially cylindrical receiving portion 22A for an indicator portion 40, a main assembly 50, a first driving portion 70, and/or an initiating device 90, with the receiving portion 22A being preferably

- 10 046799 is open in the axial direction.

In the most preferred embodiments, the frame 20, in particular the frame 22, has an axial opening 22B for insertion into the frame 20 of an indicator portion 40, a main assembly 50, a first drive portion 70, and/or an initiating device 90.

As already indicated, the first drive part 70 is preferably cap-shaped and/or at least substantially cylindrical in shape.

The first drive portion 70 preferably contains/forms the axial end of the insertion device 100.

In preferred embodiments, the first drive portion 70 includes a knob/dial 71, a collar 72, and/or a connector 73, wherein the bead 72 is preferably (axially) located between the knob/dial 71 and the connector 73, and/or the outer diameter of the bead 72 is greater than the outer diameter handle/cone scale 71 and/or connector 73.

In preferred embodiments, handle 71 extends from frame 20, particularly from axial opening 22B. In preferred embodiments, the collar 72 axially covers the frame 20 and/or the casing 30, in particular the gap between the connector 73 and the frame 20 and/or the gap between the frame 20 and the casing 30.

In preferred embodiments, the first drive portion 70 is directly attached, in particular axially attached, to the frame 20, in particular to the frame 22.

In preferred embodiments, the first drive portion 70, in particular its connector 73, is attached axially, particularly using a press fit/clamp connection, to the frame 20, in particular to the frame 22, most preferably at the axial opening 22B.

In preferred embodiments, the frame 20, in particular the frame 22, includes a group of locking elements 22C that engage radially with the first drive part 70, preferably with the connector 73 and/or with corresponding projections and/or recesses formed therein (not shown). , most preferably such that the first drive part 70 is axially fixed in the frame 20, in particular in the frame 22. However, in preferred embodiments, the first drive part 70 can move, in particular rotate, relative to the frame 20 in a given direction of rotation, as indicated by the arrow in fig. 1 and fig. 2.

In preferred embodiments, the actuator, in particular the first drive part 70, can be manually actuated by rotating it relative to the frame 20.

To facilitate rotation of the first drive portion 70, the outer surface of the first drive portion 70, in particular the handle 71, may be at least partially grooved or otherwise profiled.

In preferred embodiments, the insertion device 100, in particular the actuator and/or the first drive part 70, has/forms a rotation axis R, and preferably the first drive part 70 can rotate about the rotation axis R.

The rotation axis R preferably corresponds to or coincides with the major axis A of the insertion device 100. However, other solutions are also possible in which the rotation axis R is different from the main axis A, in particular the rotation axis R can be inclined relative to the main axis A.

In preferred embodiments, the first drive portion 70 can only be rotated in one direction, and/or the insertion device 100, in particular the frame 20, includes anti-rotation means, such as a ratchet mechanism, for the first drive portion 70.

The desired direction of rotation may be indicated on the first drive part 70, in particular on its handle 71, by means of a label, mark or the like, for example as shown in FIG. 1-3.

In the present embodiment, and as best shown in FIG. 4, the frame 20, in particular the frame 22, includes at least one anti-reverse rotation device 22D, and the first drive portion 70 includes at least one (corresponding) anti-reverse rotation stopper 74, preferably the anti-reverse rotation device 22D , the frame 20, and the stopper 74 of the first driving part 70 interact with each other in the radial direction, in particular in such a way that rotation of the driving part 70 is possible only in a given direction of rotation, and/or in such a way that reverse rotation of the first driving part is prevented or limited part 70, that is, in the direction opposite to the given direction. Specifically, the stopper 74 of the first driving portion 70 and the reverse rotation preventing device 22D of the frame 20 cooperate with each other such that they abut each other in a direction opposite to the predetermined rotation direction and/or slide against each other, for example, due to the elasticity/temporary deformation/bending of the stopper 74 of the first drive portion 70 and/or the anti-reverse rotation device 22D of the frame 20 in a predetermined direction of rotation.

In the exemplary embodiment, the frame 20, particularly the frame 22, includes a reverse rotation preventing device 22D in the form of a flexible arm extending into the interior of the frame 20, particularly the receiving portion 22A, and the first driving portion 70 includes a group of reverse rotation preventing devices 74. rotation, in the form of a set of teeth. However, other design solutions are also possible.

Anti-reverse rotation device reduces the risk of incorrect use

- 11 046799 of the insertion device 100 by rotating the first drive portion 70 in the opposite direction and can provide tactile/acoustic feedback during the initiation process, thereby increasing the usability of the insertion device 100.

Optionally, the frame 20 and/or the first drive part 70 comprises a drive stop 22E for limiting the action, in particular the rotation, of the first drive part 70 relative to the frame 20, in particular in the direction of rotation.

As this is best seen in FIG. 4, in the exemplary embodiment, the actuation stop 22E is configured as a protrusion extending radially inside the axial opening 22B/receiving portion 22A of the frame 20.

The first drive part 70 preferably includes a corresponding actuation stop (not shown), and in preferred embodiments, this stopper of the first drive part 70 abuts the stopper 22E of the frame 20 in the circumferential direction when a predetermined angular position of the first drive part 70 is reached, in particular when it reaches release positions.

As already indicated, the insertion device 100 includes, in addition to the first drive part 70, a second drive part 80.

The second drive part 80 is preferably radially/laterally attached to the frame 20, in particular to the mounting part 21. In the most preferred embodiments, the second drive part 80 and the container 10 are mounted on the frame 20, in particular to the mounting part 21 on opposite sides. Thus, the second driving part 80 and the container 10 can be mounted on the frame 20 independently of each other.

In preferred embodiments, the second drive part 80 is attached, in particular rotatably attached, to the frame 20, in particular to the mounting part 21.

In preferred embodiments, the second drive part 80 is in the form of a shell and/or laterally covers the frame 20, in particular the mounting part 21, on one side and/or partially.

In preferred embodiments, the second drive part 80 is pressed against the frame 20, in particular against the mounting part 21, most preferably in a rotatable manner.

The insertion device 100, in particular the frame 20, most preferably the mounting part 21, and/or the second driving part 80, defines/determines an axis P of rotation, and preferably the second driving part 80 can be rotated relative to the frame 20 about this axis.

As best seen in FIG. 1 and fig. 2, the rotation axis P of the second drive part preferably extends transversely, in particular at least substantially perpendicular to the major axis A of the insertion device 100 and/or the rotation axis R of the first drive part 70.

In preferred embodiments, frame 20 comprises or forms two pivot pins 23, preferably pins 23 defining a pivot axis P.

The pivot pins 23 are preferably designed as projections/fingers that extend transversely and/or radially from the frame 20.

In preferred embodiments, the second drive portion 80 comprises two slots 81, preferably each slot 81 being configured to receive a corresponding rotation pin 23, and/or each pivot pin 23 being (directly) clamped into one corresponding slot 81 of the second drive portion 80. However, others are possible. designs, in particular the second drive part 80 may contain or form rotation pins 23, and the frame 20 in this case contains or forms sockets 81 for the rotation pins 23.

In preferred embodiments, the second drive portion 80 is elongated and/or has a first (axial) end 82 and a second (axial) end 83, the rotation axis P preferably extending through the second drive portion 80 at least substantially centrally and/or between the first end is 82 and the second end is 83.

Thus, in preferred embodiments, the second drive portion 80 can be tilted relative to the frame 20, and/or the second drive portion 80 is configured as a two-state switch.

In preferred embodiments, the second drive portion 80, in particular the first end 82, preferably comprises or forms a button 84 having an oval shape, the button 84 being configured as a radial protrusion and/or projecting radially/laterally from the insertion device 100, particularly through a radial opening. 35 of the casing 30, in particular of the second casing part 32.

In preferred embodiments, the second drive part 80 can be activated by pressing the button 84, in particular in the direction of the frame 20 and/or the main axis A.

By actuating the second drive part 80, in particular by pressing the button 84, the second end 83 of the second drive part 80 is preferably lifted and/or moved away from the frame 20 and/or moved towards the housing 30.

In preferred embodiments, the second end 83 of the second drive part 80 is in the form of a radial, in particular plate-like, protrusion and/or projects radially into the frame 20, in particular into the frame 22 of the frame 20, and/or in the direction of the main axis A.

In preferred embodiments, the second drive portion 80, in particular its second end 83, with

- 12 046799 holds or forms at least one drive spring 83A, most preferably in the form of an elastic projection/bracket.

The frame 20, preferably the frame 22, in particular the receiving part 22A, preferably includes a lower part 22F, with the second end 83 of the second driving part 80, in particular the driving spring 83A, preferably bearing radially on the lower part 22F. In other words, the lower portion 22F preferably serves as a support and/or forms a support surface for the drive spring 83A.

In preferred embodiments, the drive spring 83A in the home position of the insertion device 100 is prestressed, particularly by the bottom portion 22F, so that it is most preferable that the second drive portion 80 can be actuated against the elastic force/energy of the drive spring 83A. In this way, the risk of unintentionally actuating the second drive portion 80 is reduced.

In preferred embodiments, the second drive portion 80, particularly its second end 83, comprises or forms a frame 83B and/or an opening 83C, with the main assembly 50 preferably extending through the frame 83B and/or the opening 83C.

By actuating the second drive portion 80, in particular pressing the button 84, the (radial) position of the frame 83B and/or the hole 83C relative to the main assembly 50 is changed, resulting in an axial locking or release of the main assembly 50, as will be described below in more detail. .

Typically, medical devices, such as, for example, the delivery device 100, are sterilized, in particular with and/or under the influence of a sterilizing agent, in particular with a sterilizing gas such as ethylene oxide. In such sterilization processes, it is especially important to expose all surfaces of the medical device that the user/practitioner may come into contact with the sterilizing agent.

For this purpose, the casing 30 and/or the second driving part 80 preferably contains/contains at least one spacer 85, wherein preferably the spacer 85 is adapted to provide clearance between the casing 30 and the second driving part 80, in particular in the immediate vicinity of the button 84, and /or even in the initial state of the insertion device 100 (the device is not activated).

In this way, the contact surface when sterilizing the administration device 100 is maximized. In particular, a sterilizing agent, such as ethylene oxide, may penetrate into the gap between the housing 30 and the second drive portion 80 during the sterilization process, so that the entire button 84 is exposed to the sterilizing agent. As already indicated, the device 100 for introduction, in particular its actuator, contains a main node 50, and the main node 50 is preferably located within the frame 20 and/or relative to it with the ability to move.

In preferred embodiments, the main assembly 50 is adapted to (directly) act on and/or support the plug 18. In particular, the main assembly 50 is adapted to push the plug 18 towards the outlet of the container 10 and/or to push the fluid 11 therefrom.

However, in preferred embodiments, the plug 18 is not rigidly attached to the main assembly 50, particularly to its tip. In preferred embodiments, plug 18 is simply pressed against and/or loosely connected to main assembly 50, particularly its tip. In other words, the main assembly 50 and plug 18 are configured to connect only under pressure, and/or when the main assembly 50 pushes the plug 18. In preferred embodiments, the main assembly 50 and plug 18 are configured to release under tension, and/or when the main assembly 50 is withdrawn /pulled out of the container 10. In this case, air is prevented from being sucked into the container 10, for example during the sterilization process.

In the initial position of the insertion device 100, the plug 18 may also be separated from the main assembly 50 in the axial direction such that the main assembly 50 will abut the plug 18 only when the first drive portion 70 is actuated.

The main assembly 50 is preferably elongated and/or rod-shaped.

In the most preferred embodiments, the main assembly 50 extends (fully) axially through the insertion device 100, preferably through the frame 20, in particular from the first drive part 70 through the frame 20 into the container 10.

In particular, the main assembly 50 extends from the housing 30, in particular from the second axial opening 34.

In preferred embodiments, the main assembly 50 includes a rod/connecting rod 51, an intermediate portion 52, and/or an end portion 53, with the intermediate portion 52 (in the axial direction) located between the rod/connecting rod 51 and the end portion 53.

The rod/connecting rod 51, referred to below as the rod rod 51, preferably contains or forms the (first) axial end and/or tip of the main assembly 50. In preferred embodiments, the rod rod 51 fits into the container 10 and/or (directly) faces the side

- 13 046799 plugs 18.

The end portion 53 of the main assembly 50 preferably contains or forms the (second) axial end of the main assembly 50. In preferred embodiments, the end portion 53 faces away from the plug 18 and/or mechanically cooperates with the first driving portion 70 and/or at least partially engages it, as will be described below in more detail.

The rod rod 51 is preferably elongated and/or rod-shaped.

In the exemplary embodiment, the rod rod 51 preferably has at least a substantially rectangular cross-section. However, other design solutions are also possible, in particular the rod rod 51 may have a circular cross-section.

In preferred embodiments, the outer dimensions of the rod rod 51 are smaller than the internal diameter of the container 10, in particular its main body 12, so that preferably the rod rod 51 can move freely and/or without friction within the container 10. In preferred embodiments, the rod rod 51 has a front portion 51A and rear part 51B.

In preferred embodiments, the front portion 51A is a portion of the rod shaft 51 that at least partially engages the container 10 and/or (directly) faces or abuts the plug 18.

In preferred embodiments, the rear portion 51B is a portion of the rod shaft 51 that protrudes from the container 10 and/or constitutes or forms a transition between the front portion 51A and the intermediate portion 52 of the main assembly 50.

In preferred embodiments, the rod rod 51, particularly the front portion 51A, has a constant shape. However, the shape of the rod rod 51, particularly its rear portion 51B and/or the portion adjacent to the intermediate portion 52, may also vary in the direction of the major axis A.

In preferred embodiments, the rear portion 51B of the rod shaft 51 is stepped and/or radially offset compared to the front portion 51A of the stem shaft 51. In preferred embodiments, the rod shaft 51, particularly the rear portion 51B thereof, comprises or forms a first stopper 51C and/or a second stopper 51D, preferably the first stopper 51C and/or the second stopper 51D being formed/formed by the (radial) shoulder/protrusion of the stem shaft 51 , in particular its rear portion 51B, best illustrated in FIG. 6.

In preferred embodiments, the second drive portion 80, in particular the frame 83B, comprises or forms a locking element/locking portion 83D, wherein the locking element/locking portion 83D is preferably configured to lock the main assembly 50 in an axial direction, particularly by engaging the first stopper 51C and/or with a second stopper 51D.

By activating the first drive portion 70 and/or the second drive portion 80, the main assembly 50 preferably moves toward the outlet of the container 10 and/or further into the container 10 and/or away from the first drive portion 70.

In preferred embodiments, the direction of movement of the main assembly 50 is parallel, in particular along the main axis A.

In addition to, or instead of, the anti-reverse rotation device for the first drive portion 70, the insertion device 100 may be provided with a reverse movement inhibitor, in particular a ratchet mechanism, for the main assembly 50, preferably to prevent or at least limit the reverse movement of the main assembly 50 , in particular (only) during the initialization process and/or during the sterilization process of the administration device 100.

In preferred embodiments, the frame 20 and the main assembly 50 interact mechanically and/or axially with each other such that the main assembly 50 can move in a (predetermined) direction and/or further into the container 10 and/or further away from the first actuator part 70, and/or that the main assembly 50 is prevented from moving back, that is, moving the main assembly 50 out of the container 10 and/or away from the container outlet, particularly (only) during the initialization process.

As can best be seen in FIG. 5, which shows a longitudinal sectional view of the insertion device 100 in its initial position/state, the frame 20, in particular the lower part 22F of the receiving part 22A, preferably includes an opening/slot 22G for the main assembly 50, in particular for the rod shaft 51, wherein the main assembly 50, particularly the rod shaft 51, preferably extends through an opening/slot 22G of the frame 20. In preferred embodiments, the opening 22G radially guides the main assembly 50 and/or prevents or limits possible rotation of the main assembly 50 relative to the frame 20.

In preferred embodiments, frame 20, particularly frame 22, includes at least one backstop 24, best illustrated in FIG. 5.

In preferred embodiments, the main assembly 50, in particular the rod shaft 51, includes a (corresponding) backstop 51E, wherein the backstop 24 of the frame 20 and the backstop 51E of the main assembly 50 form a backstop of the insertion device 100 and/or interact axially each other such that the main assembly 50 can only move in a (predetermined) direction towards the container 10 and/or further into the container 10, and/or that the movement of the main assembly 50 in the direction opposite to the (predetermined) direction movement in and/or out of the container 10 and/or towards the first driving part 70 is prevented or at least limited, in particular only or at least during the initialization and/or actuation of the first driving part 70.

Specifically, the backstop 24 of the frame 20 and the backstop 51E of the main assembly 50 cooperate with each other so that they abut each other in a direction opposite to the predetermined direction of movement and/or slide against each other, for example, by elasticity/temporary deformation/bending of the backstop 24 of the frame 20 and/or the backstop 51E of the main assembly 50, in a given direction of movement.

In the present embodiment, the main assembly 50, in particular the rod rod 51, preferably includes a group of backstops 51E, in particular in the form of a series of teeth located on opposite sides of the rod rod 51, in particular its front part 51A.

In preferred embodiments, the frame 20 includes a group of corresponding backstops 24 in the form of (two) elastic brackets that interact radially with the corresponding backstops 51E of the main assembly 50 on both sides.

In most preferred embodiments, the backstops 51E located on one side of the rod bar 51 are axially offset relative to the backstops 51E located on the other side of the rod bar 51, particularly in such a way that the ends of the stoppers 51E on each side of the rod bar 51 are not aligned. . Thus, the axial position of the main assembly relative to the frame 20 is reliably ensured in small steps. In preferred embodiments, the backstops 24 of the frame 20 and the backstops 51E of the main assembly 50 form a backstop, such as a ratchet.

In preferred embodiments, the group of stops 51E is located only on a portion of the main assembly 50, particularly on the rod shaft 51, most preferably on the front portion 51A thereof, and/or not throughout the main assembly 50, in particular not on the entire stem shaft 51, most preferably not along the entire front of 51A.

As already indicated, in preferred embodiments, reverse movement of the main node 50, that is, movement of the main node from the container 10, is prevented or at least limited only or at least during the initialization process.

In other words, the group of stoppers 51E of the main assembly 50 and the stoppers 24 of the frame 20 preferably only or at least mechanically interact with each other and/or (axially) engage with each other during the initialization and/or actuation of the first drive part 70 .

The backstop may provide acoustic/tactile feedback during the initialization process, particularly in addition to and/or different from the acoustic/tactile feedback of the anti-backlash device, most preferably such that the user/practitioner can clearly discern the initialization, and/or when the insertion position/state is reached.

As shown in FIG. 3 and fig. 4, the main assembly 50, in particular the intermediate portion 52, preferably contains or forms at least one indicator means. In the exemplary embodiment, the indicator means is in the form of a pin 52A/52B, the pin 52A/52B preferably projecting radially from the main assembly 50 and/or towards and/or into the frame 20, in particular the frame 22. However, other design solutions are also possible, for example, the indicator means can be made in the form of a strip, preferably having an arcuate shape, in particular extending radially from the main unit 50.

In preferred embodiments, the frame 20 includes in particular a longitudinal and/or axial recess 22H/22J, the pin 52A/52B being preferably guided by this recess 22H/22J, in particular in a circumferential direction and/or in such a way that rotation is prevented or at least limited main node 50 relative to frame 20.

In preferred embodiments, the indicator means, particularly the pin 52A/52B, is visible from the outside of the insertion device 100 and/or through the housing window 36, as shown in FIG. 1. Thus, the axial position of the main assembly 50 relative to the frame 20 is indicated and/or visible to the user/practitioner of the administration device 100. Thus, in preferred embodiments, indicator means, particularly pin 52A/52B, are used to both guide the main assembly 50 and indicate its axial position.

In preferred embodiments, the frame 20 is made at least in part from a transparent material. In the most preferred embodiments, at least the portion of the frame 20 covering the indicator means, in particular the pin 52A/52B, is at least partially transparent so that the indicator means, in particular the pin 52A/52B, is visible from the outside and/or through the housing window 36. However, the frame 20 may also be provided with a cutout so that the indicator means, in particular the pin 52A/52B, is visible from the outside and/or through the housing window 36.

- 15 046799

In the exemplary embodiment, the main assembly 50 preferably includes a first pin 52A and a second pin 52B, and the frame 20 preferably includes a first recess 22H and a second recess 22J, particularly on opposite sides of the main assembly 50 and frame 20, and preferably the first pin 52A fits into the first recess 22H, and the second pin 52B fits into the second recess 22J. In this way, the main assembly 50 is guided on both sides and the risk of jamming is reduced.

As already indicated, the insertion device 100 preferably includes an indicator portion 40 for indicating the status of the insertion device 100 and/or the axial position of the main assembly 50 relative to the frame 20.

In preferred embodiments, the indicator part 40 is made in the form of a hollow cylinder and/or sleeve.

In preferred embodiments, the indicator portion 40 is located within the frame 20, particularly within the receiving portion 22A.

In preferred embodiments, the main assembly, in particular the intermediate portion 52, is located within the indicator portion 40.

In preferred embodiments, the indicator portion 40 radially surrounds the main assembly 50, in particular the intermediate portion 52, and/or is located radially between the main assembly 50, in particular between the intermediate portion 52, and the frame 20, in particular the frame 22. However, the main assembly 50, in in particular, its indicating means may also partially cover the indicator part 40 and/or be viewed from the outside, in particular when designed in the form of an arcuate strip in the preferred embodiments.

In preferred embodiments, the indicator portion 40 may rotate relative to and/or within the frame 20, particularly relative to/within the receiving portion 22A, and/or relative to and/or around the main assembly 50, particularly relative to/around the intermediate portion 52. However, in preferred embodiments the indicator part 40 is fixed in the axial direction within the frame 20 and/or by the frame 20.

In accordance with one aspect of the present invention, the indicator portion 40 can preferably be rotated (directly) by axial movement of the main assembly 50, in particular its pin 52A/52B. In preferred embodiments, the indicator portion 40 can be rotated by (direct) (axial) movement of the main assembly 50, in particular its pin 52A/52B.

In other words, in preferred embodiments, actuation, in particular rotation of the first drive part 70, causes axial movement of the main assembly 50, which in turn causes rotation of the indicator part 40.

In one preferred embodiment (not shown), the indicator portion 40 is rotated (directly) by the (axial) movement of the main assembly 50 only after reaching the insertion position/state and/or when moving from the insertion position/state to the final position/state, in particular to indicate that the end position/state has been reached. In this embodiment, the indicator portion 40 preferably does not rotate during the initialization process.

In preferred embodiments, the indicator portion 40 includes an axial hole 41A/41B and/or a helical/oblique slot/surface 42A/42B, wherein the pin 52A/52B can preferably be inserted axially into the hole 41A/41B and/or the helical/oblique slot/surface 42A/42B of the indicator portion 40, particularly through an opening 41A/41B into the helical/oblique slot/surface 42A/42B, and/or the main assembly 50, in particular the pin 52A/52B, axially bears/engages with the helical/oblique slot/surface 42A/42B, in particular only after reaching the insertion position/state and/or during the transition from the insertion position/state to the final position/state.

In preferred embodiments, the hole 41A/41B is extended by a helical/oblique slot/surface 42A/42B, and/or the hole 41A/41B is formed by an (axial) helical/oblique slot/surface 42A/42B, and/or a helical/oblique slot/surface 42A/ 42B extends helically in the circumferential direction of the indicator portion 40.

In preferred embodiments, the pin 52A/52B projects radially into the slot/surface 42A/42B such that axial movement of the main assembly 50, particularly the pin 52A/52B, causes the indicator portion 40 to rotate relative to the frame 20 and/or relative to the main assembly 50.

In the exemplary embodiment, the indicator portion 40 includes a first axial hole 41A and/or a first helical slot/surface 42A for the first pin 52A, and a second axial hole 41B and/or a second helical slot/surface 42B for the second pin 52B. Thus, jamming of the indicator portion 40 can be prevented.

In one preferred embodiment (not shown), the main assembly 50 axially engages/supports the helical slot/surface 42A/42B only after reaching the insertion position/state and/or during the transition from the insertion position/state to the final position/state, in particular in such a way that the indicator part 40 is driven into rotation

- 16 046799 (axial) movement of the main assembly 50 only after reaching the insertion position/state and/or during the transition from the insertion position/state to the final position/state.

In preferred embodiments, the indicator portion 40 is configured to indicate the status of the insertion device 100 and/or the axial position of the main assembly 50. For this purpose, the indicator portion 40 preferably includes at least one indicator means 43, such as, for example, a label, mark or similar indicator , on the outer surface of the indicator portion 40, as best shown in FIG. 4.

In preferred embodiments, the indicator portion 40, in particular the indicator means 43, is visible from the outside and/or through the housing window 36, in particular continuously, during initialization, injection and/or in the initial position/state, in the insertion position/state and/or in final position/state.

As already indicated, the insertion device 100 can be initialized, in particular by actuating, most preferably rotating, the first driving part 70.

By activating, most preferably by rotation, the first drive part 70, the main assembly 50 moves (axially), in particular such that the rod rod 51 moves/pushes the plug 18 further into the container 10 and/or towards its outlet. In preferred embodiments, the insertion device 100, in particular the actuator, includes an initiating device 90 that mechanically connects the main assembly 50 to the first driving part 70 and/or mechanically interacts with the first driving part 70, in particular in such a way that the actuation, in particular, rotation of the first driving part 70 causes axial movement of the main assembly 50, in particular to initialize the insertion device 100.

The design and features of the initiating device 90 will be described below with reference to FIGS. 5 and fig. 6, where FIG. 5 is a schematic longitudinal sectional view of the insertion device 100 in its initial position/state, and FIG. 6 is a schematic longitudinal sectional view of the insertion device 100 in its initial position/state, rotated 90° about its major axis A, compared with FIG. 5.

As already indicated, the initiating device 90 is preferably at least partially located within the first driving part 70, at least in the initial position/state.

In preferred embodiments, the first driving portion 70 comprises or forms a receiving portion 75, with the initiating device 90 preferably located within and/or being received within the receiving portion 75 of the first driving portion 70, at least in its initial position/state.

However, the first drive part 70, in particular its connector 73, may also be inserted and/or at least partially located within the initiating device 90.

In preferred embodiments, the initiating device 90 is of a multi-component design and/or contains multiple parts/components.

In preferred embodiments, initiating device 90 includes a first portion 91 and a second portion 92.

In preferred embodiments, the second portion 92 is rigidly coupled to the main assembly 50, particularly its end portion 53, or formed by the main assembly 50. Most preferably, the second portion 92 and the main assembly 50 are formed as one piece/piece. However, the second part 92 may also be a separate part/component.

In preferred embodiments, the initiating device 90, in particular its first part 91 and/or its second part 92, is/is designed in the form of a hollow cylinder. In preferred embodiments, the initiating device 90, in particular its first part 91 and/or its second part 92, comprises and/or forms a spring chamber 93, in particular in the radial and axial directions.

In preferred embodiments, the drive spring 60 is located within the initiating device 90, particularly in the spring chamber 93, and/or is enclosed in the initiating device 90, in particular in the first portion 91 and in the second portion 92.

In preferred embodiments, the first part 91 and the second part 92 are axially connected to each other with the possibility of their separation. In particular, the first part 91 and the second part 92 are (axially) inserted into each other, for example, using a press fit.

In particular, the drive spring 60/spring force/spring energy is designed to move, in particular push the first part 91 and the second part 92 away from each other.

In preferred embodiments, the drive spring 60 is pre-tensioned, most preferably compressed, in the initial state of the insertion device 100, particularly in such a way that the first part 91 and the second part 92 are repelled by the spring 60 from each other.

In preferred embodiments, the drive spring 60 is in the form of a cylindrical/coil spring and/or made of metal, in particular stainless steel.

In preferred embodiments, the first portion 91 and the second portion 92 of the initiating device 90 comprise a rear portion 91A/92A, respectively, and/or preferably a cylindrical wall

- 17 046799

91B/92B, wherein the rear portion 91A of the first portion 91 and the rear portion 92A of the second portion 92 define the spring chamber 93 in the axial direction, and/or the wall 91B of the first portion 91 and/or the wall 92B of the second portion 92 define/limit the spring chamber 93 radially direction.

In preferred embodiments, the rear portion 91A of the first portion 91 and the rear portion 92A of the second portion 92 are located (axially) on opposite sides and/or define the spring chamber 93 (axially) on opposite sides. In the present embodiment, the second part 92 is partially inserted into the first part 91, in particular in such a way that the wall 91B of the first part 91 at least partially surrounds the wall 92B of the second part 92 and/or is located (immediately) adjacent to the first driving part 70.

However, the first part 91 may also be included in the second part 92.

In preferred embodiments, drive spring 60 is axially supported and/or pressed against rear portion 91A of first portion 91 and rear portion 92A of second portion 92.

The first part 91, in particular its rear part 91A, preferably contains or forms a (first) seat 91C of the spring 60, and the second part 91, in particular its rear part 92A, preferably contains or forms a (second) seat 92C of the spring 60, in particular for the corresponding (axial) ends of the spring 60.

In particular, to prevent bending of the drive spring 60, the rear portion 91A of the first portion 91 and/or the rear portion 92A of the second portion 92 may be provided with or form a spring pin 91D, which pin extends axially within the spring 60.

In accordance with another aspect of the present invention, the insertion device 100, in particular its actuator, includes a lead screw, the first driving part 70 on the one hand, and the main assembly 50 and/or the initiating device 90 on the other hand (directly) interact with each other in a movable manner and/or are (directly) connected to each other by means of a lead screw, and/or the first drive part 70 is rotatable (manually), in particular relative to the frame 20 and/or the container 10 for axial movement of the main assembly 50, the drive spring 60 and/or the initiating device 90, particularly relative to the frame and/or the container 10, most preferably such that rotation of the first drive part 70 causes the main assembly 50, the drive spring 60 and/or the initiating device 90 to move from from the initial position to the release position and/or in the direction of the insertion position, axially and/or in the direction of the plug 18 and/or the outlet of the container 10.

Thus, the lead screw is designed to convert rotation (by hand) of the first drive portion 70 into linear, particularly axial, movement of the main assembly 50, the drive spring 60 and/or the initiating device 90. In preferred embodiments, the first drive portion 70 includes a screw thread 76, and/or the initiator device 90 includes a screw thread 94, wherein preferably the screw thread 76 of the first drive portion 70 and the screw thread 94 of the initiator portion 90 (mechanically) cooperate with each other.

In the present embodiment, the screw thread 76 of the first driving part 70 is formed in the form of an internal screw thread, and the screw thread 94 of the initiating part 90 is formed in the form of an external screw thread. However, the screw thread 76 of the first drive portion 70 may also be formed as an external screw thread, and the screw thread 94 of the initiation portion 90 may also be formed as an internal screw thread.

Thus, in preferred embodiments, the initiating device 90 is screwed into the first driving part 70, in particular into the receiving part 75, at least in the initial position/state, and/or can be unscrewed from the first driving part 70, in particular from its receiving part part 75 by rotating the first drive part 70.

In preferred embodiments, the screw thread 76 of the first drive portion 70 is formed by a helical projection that extends into the receiving portion 75.

In preferred embodiments, the screw thread 94 of the initiation portion 90 is formed by a projection and/or recess on the wall 91B of the first portion 91 and/or on the wall 92B of the second portion 92 thereof.

In most preferred embodiments, the screw thread 94 is formed by both a first portion 91, particularly its wall 91B, and a second portion 92, particularly its wall 92B.

In preferred embodiments, the first portion 91, in particular its wall 91B, contains or forms a (first) threaded portion 91E, and the second portion 92, in particular its wall 92B, contains or forms a (second) threaded portion 92E, wherein the threaded portion 91E and the threaded portion portion 92E (together) form, in particular, a continuous screw thread 94 of the initiating device 90.

As can best be seen in FIG. 3 and fig. 4, the threaded portion 91E and/or the wall 91B of the first portion 91 is preferably partially recessed/cut out. In preferred embodiments, the first portion 91, in particular its wall 91B, includes a cutout 91F for the second portion 92, in particular its threaded portion 92E.

In preferred embodiments, a threaded portion 92E of the second portion 92 may be inserted or inserted (axially) into the first portion 91, particularly its slot 91F, such that the threaded portion 91E of the first portion 91 and the threaded portion 92E of the second portion 92 form a (continuous) screw thread 94 initiations

- 18 046799 routing device 90.

In preferred embodiments, the threaded portion 92E of the second portion 92 is formed by a radial projection of the wall 92B of the second portion 92 that extends through/into the wall 91B of the first portion 91, particularly the slot 91F, and/or that is flush with the outer surface of the wall 92B of the second portion 92.

In other words, the second part 92, in particular its threaded part 92E, engages with the first part 91, in particular its wall 91B and/or the slot 91F, radially/rotational and/or in the circumferential direction, and/or thus that the first part 91 and the second part 92 cannot be rotated relative to each other, preferably at least during the initialization process and/or until the insertion position is reached.

Optionally, the first portion 91 and the second portion 92 may be engaged with each other using additional elements. In the present embodiment, the first part 91, in particular its wall 91B, contains a groove 91G, and the second part 92, in particular its wall 92B, contains a corresponding protrusion 92G, this protrusion 92G preferably being in engagement with the groove 91G, radially/rotational and/ or in the circumferential direction, preferably at least during the initialization process and/or until the insertion position is reached.

Various states of the insertion device 100 and interactions between parts/components of the insertion device 100 during use will be described with reference to FIGS. 5-15.

In fig. 5 and fig. 6 shows the insertion device 100 in its initial position/state, that is, before the first driving part 70 is activated. FIG. 7 and fig. 8 shows the insertion device 100 in the release position, that is, after the first driving part 70 has been activated. FIG. 9 and fig. 10 shows the insertion device 100 in the insertion position/state, that is, after initialization and/or immediately after activation of the second driving part 80. In FIG. 11 and fig. 12 shows the insertion device 100 in its final position/state, that is, after the second drive part 80 has been activated.

In preferred embodiments, the home position is the (axial) position of the main assembly 50, plug 18, drive spring 60, and/or initiating device 90 relative to the frame 20 and/or container 10 before initializing the insertion device 100 and/or before actuating the first actuator parts 70 and/or in the initial state of the insertion device 100.

In the initial state of the insertion device 100, and/or when the main assembly 50, the plug 18, the drive spring 60 and/or the initiating device 90 are/is in the initial position, the first driving part 70 and the second driving part 80 are not driven.

In preferred embodiments, it is not possible to (directly) actuate the second drive portion 80 and/or (directly) inject fluid 11 in the initial state of the injection device 100, and/or when the main assembly 50, plug 18, drive spring 60 and/or trigger the device 90 is/is in its original position.

In the initial position/state, the initiating device 90, in particular its first part 91 and/or the second part 92, and/or the end part 53 of the main assembly 50 is preferably completely located inside the first driving part 70, in particular inside its receiving part 75.

In preferred embodiments, the rear portion 91A of the first portion 91 (axially) rests on the axial end of the first drive portion 70 in the initial state/position.

In preferred embodiments, the (axial) length of the drive spring 60 corresponds to the (axial) length of the spring chamber 93, that is, the (axial) distance between the rear portion 91A/spring seat 91C of the first portion 91 and the rear portion 92A/spring seat 92C of the second portion 92.

In the initial position/state, the drive spring 60 is (most) tense/compressed, the spring chamber 93 is compressed to the greatest extent, and/or the length of the drive spring 60 and/or the spring chamber 93 is minimal compared to other positions/states, and/ or corresponds to the first and/or minimum length L1 (see Fig. 5), wherein the first/minimum length L1 is greater than 10 mm or 15 mm, and/or less than 30 mm or 25 mm. As already indicated, the drive spring 60 preferably moves, in particular pushes, the first part 91 and the second part 92/main assembly 50 away from each other.

In preferred embodiments, the first drive portion 70 comprises or forms a locking element 77, which element is preferably configured to prevent release of the drive spring 60 and/or movement of the second portion 92/main assembly 50 relative to the first portion 91 in the original position/state, and/or during the actuation of the first drive portion 70, and/or during the movement of the plug 18, the main assembly 50, the drive spring 60 and/or the initiating device 90 from the initial position to the release position.

In preferred embodiments, the locking element is in the form of a protrusion/rib that fits helically into the receiving portion 75 of the first drive portion 70.

In preferred embodiments, the locking element 77 comprises or forms a screw thread 76 of the first drive portion 70, or vice versa. However, other design solutions are also possible, in particular the fixing element 77 and the screw thread can be made as separate

- 19 046799 parts/elements.

In preferred embodiments, the locking element 77/screw thread 76 is/is designed to hold the first part 91 and the second part 92/main assembly 50 together in the axial direction, at least in the initial position/state, until the release position is reached, and/or during the actuation of the first drive part 70, and/or during the movement of the plug 18, the main assembly 50, the drive spring 60 and/or the initiating device 90 from the initial position to the release position.

In particular, the locking element 77/screw thread 76 is (axially) engaged with the threaded part 92E of the second part 92, so that the second part 92, in particular the threaded part 92E of the second part 92, cannot be pushed away from the first part 91, in particular from its slot 91F, by means of the drive spring 60, at least in the initial position/state, and/or until the release position is reached, and/or during the actuation process of the first drive part 70, and/or during the movement of the plug 18, the main assembly 50, drive spring 60 and/or initiating device 90 from the release position to the release position. As already indicated, in preferred embodiments, the second drive part 80 cannot be actuated in the initial state/position, during the actuation of the first drive part 70 and/or while the plug 18, the main assembly 50, the drive spring 60 and/or the initiating device are moving 90 from the starting position to the insertion position.

As already indicated, in preferred embodiments, the second drive part 80 cannot be actuated in the initial state/position, during the actuation of the first drive part 70 and/or while the plug 18, the main assembly 50, the drive spring 60 and/or the initiating device are moving 90 from the starting position to the insertion position.

The second drive portion 80, in particular its second end 83, most preferably the frame 83B, preferably contains or forms a locking element 83E, wherein the locking element 83E preferably prevents the second drive portion 80 from being activated in the initial state/position and/or before reaching the position/ state of administration, as best seen in FIG. 6.

In preferred embodiments, the locking element 83E engages/supports radially on the main assembly 50, in particular on the rod rod 51, most preferably in such a way that the second drive part 80, in particular its button 84, cannot be operated, in particular pressed.

In preferred embodiments, the position and/or angle of rotation of the second drive part 80, in particular relative to the axis P of rotation, is at least fixed and/or limited in the initial state/position and/or during the movement of the plug 18, the main assembly 50, the drive spring 60 and the initiating device 90 from the starting position to the insertion position by means of a frame 83B that is engaged or supported by the main assembly 50, in particular the rod rod 51, on both sides, as shown in FIG. 6 below and above.

In particular, the position and/or rotation angle of the second drive portion 80 is at least substantially fixed and/or limited in the initial state/position and/or during movement of the plug 18, the main assembly 50, the drive spring 60 and/or the initiating device 90 from the initial position to the insertion position by means of the locking member 83E engaged or supported by the main assembly 50, in particular the rod rod 51, on one side, from the bottom in FIG. 6, and by means of a locking element 83D engaged or supported by the main assembly 50, in particular the rod rod 51, on the other hand, from above in FIG. 6. As best seen in FIG. 5, the backstop, particularly the backstop 51E of the main assembly 50 and the backstop 24 of the frame 20, is preferably not (yet) engaged and/or latched properly in the original state/position.

By actuating, in particular by rotating, the first drive part 70, the plug 18, the main assembly 50, the drive spring 60 and/or the initiating device 90 can be moved, in particular pushed, from the initial position, in particular from the initial position to the release position, and/or from the release position to the insertion position.

In preferred embodiments, the initiating device 90, in particular the first part 91 and/or the second part 92, and/or the main assembly 50 can be unscrewed from the first driving part 70 by actuating, in particular rotating, the first driving part 70 using a lead screw .

In preferred embodiments, before reaching the release position, the first part 91 and the second part 92/main assembly 50 are moved together and/or as a unit and/or without moving the first part 91 and the second part 92/main assembly 50 relative to each other.

That is, in preferred embodiments, the length of the drive spring 60 and/or the spring chamber 94 remains constant and/or does not change until the release position is reached and/or until the locking element 77/screw thread 76 of the first drive portion 70 engages with the initiating part 90, in particular with the first part 91, most preferably with its threaded part 91E.

- 20 046799

In fig. 7 and fig. 8 shows the insertion device 100 in the release position, that is, after the first driving part 70 has been activated.

In preferred embodiments, the release position is the (axial) position of the main assembly 50, plug 18, drive spring 60 and/or initiating device 90 relative to the frame 20 and/or container 10 between the initial position and the insertion position, and/or after completion of the first actuation part 70, and/or (immediately) before reaching the insertion position/state and/or (immediately) before completing the initialization. By actuating, in particular by rotation, the first drive part 70, the plug 18, the main assembly 50, the drive spring 60 and/or the initiating device 90 are axially moved, in particular pushed/pushed, towards the outlet of the insertion device 100 and/or or container 10 and/or away from the first drive part 70, preferably at least 5 mm or 8 mm, and/or at most 30 mm or 20 mm, in particular at least substantially 10 mm.

In particular, the distance D between the main assembly 50 and/or the initiating device 90, in particular the first part 91, most preferably its rear part 91A, on the one hand, and the first driving part 70, in particular its rear part, on the other hand, increases.

At the release position and/or upon reaching the release position, the drive spring 60/spring force/spring energy is preferably (automatically) at least partially released/released such that subsequent movement of the main assembly 50, the second portion 92 and/or the plug 18 in the direction the injection position and/or in the outlet direction of the injection port 100 is completed and/or supported by the drive spring 60, and/or the transition of the injection device 100 from the initial state to the injection state is completed and/or supported by the drive spring 60.

In the release position and/or upon reaching the release position, the screw thread 76/locking element 77 and the second part 92, in particular the threaded part 92E thereof, are (axially) disengaged, most preferably such that the drive spring 60 is partially released and/or can be partially released, and/or the second part 92, in particular its threaded part 92E, can be at least partially pushed out of the first part 91, in particular from the slot 91F, by means of the drive spring 60. Thus, the initialization is completed, and/or insertion position reached.

Thus, in accordance with one aspect of the invention, the initialization and/or movement of the main assembly 50, the second part 92 and/or the plug 18 during the initialization process and/or from the initial position to the insertion position is completed half manually/half automatically and/or manually, that is, by actuating, in particular by rotation, the first drive part 70 and automatically, that is, by at least partially decompressing/releasing the drive spring 60/spring force/spring energy (after reaching the release position and/or transition from release position to insertion position). As already indicated, the first part 91 and the second part 92 of the initiating device 90 are in engagement with each other, and/or the second part 92 is preferably configured to limit the radial/rotational movement of the second part 92 and/or its movement in the circumferential direction, preferably thus that the first part 91 and the second part 92 cannot rotate relative to each other, in particular at least during the initialization process and/or until the insertion position is reached.

In one preferred embodiment (not shown), the first portion 91 and the second portion 92 of the initiating device 90 are disengaged from each other, and/or the second portion 92 is preferably configured to release the second portion 92 for radial/rotational movement and/or movement in the circumferential direction, preferably in such a way that the first part 91 and the second part 91 can be rotated relative to each other after initialization, and/or at least temporarily, and/or upon reaching the insertion position.

In preferred embodiments, after initialization and/or upon reaching the insertion position, the drive spring 60/spring force/spring energy is at least partially released/released (optional) and/or the first part 91 moves, in particular rotates, back into the first drive part 70 and/or towards it under the action of the drive spring 60, most preferably until the first part 91 and the second part 92 reengage with each other and/or until the first part 91 strikes the corresponding stop of the second parts 92.

In this way, an acoustic/tactile feedback signal is provided which clearly indicates the end of the initialization and/or the achievement of the insertion position, in particular as a distinguishable complement to the acoustic/tactile signal of the backstop, most preferably in such a way that the user/practitioner can clearly distinguish between initialization and/or achievement of the insertion position/state.

By actuating, in particular by rotating, the first driving part 70, an axial movement of the main assembly 50, in particular its rod rod 51, is carried out, in particular the main assembly 50 is pushed (further) through the rear part 22F of the frame 22, and/or (further) through second end

- 21 046799

83, and/or through the hole 83C, and/or through the frame 83B of the second drive part 80.

As best seen in FIG. 7, after actuation of the first driving part 70, and/or at least between the initial position and the release position, and/or during the initialization process, the backstop of the actuator is preferably activated, and/or the backstop 24 of the frame 20 is preferably activated ( axially) engages with the reverse stopper 51E of the main assembly 50.

Thus, after actuation of the first driving part 70 and/or at least between the initial position and the release position and/or during the initialization process, backtracking of the main assembly 50 is preferably prevented or at least limited by the backstop in the direction out of the container 10 and/or in the direction of the first driving part 70.

As best seen in FIG. 8, the position and/or rotation angle of the second driving part 80 is preferably (still) at least substantially fixed and/or limited in the release position by the frame 83B, in particular by the locking element 83E and/or the locking element 83D located (radially) in engaged with or supported by the main assembly 50, in particular the rod rod 51, on both sides, in FIG. 8 below and above.

In preferred embodiments, the second drive portion 80, in particular the locking member 83D of the second drive portion 80, is axially spaced from the first stopper 51C of the main assembly 50 and/or is not axially engaged/blocking the main assembly 50, in particular the rod rod 51, most preferably in the initial position/state, and/or in the release position, and/or throughout the initialization process.

In preferred embodiments, the second drive part 80, in particular the locking element 83D of the second drive part 80, is axially engaged/locks the main assembly 50, in particular the rod rod 51, only after completion of initialization and/or injection, and/or only in position/ the insertion state, and/or the final position/state, as will be described below with reference to FIGS. 9, 10, and also in Fig. 11, 12.

In fig. 9 and fig. 10 shows the insertion device 100 in the insertion position, that is, after the drive spring 60 has been partially released and/or after initialization has been completed.

In preferred embodiments, the insertion position is the (axial) position of the main assembly 50, plug 18 and/or initiating device 90 relative to the frame 20 and/or container 10 (immediately) after completion of the initialization process, and/or (immediately) after (complete ) actuating, in particular rotating, the first driving part 70. and/or (immediately) before performing an injection, and/or in a state of insertion of the injection device 100. In the insertion state of the insertion device 100, the first driving part 70 has been (fully) operated, and the second driving part 80 has not (yet) been driven.

In particular, in the state of insertion of the administration device 100, the second driving part 80 can be (directly) actuated, in particular pressed, and/or the fluid can be administered to the patient without performing further steps other than actuating the second driving part 80.

As already indicated, the drive spring 60 preferably moves, in particular pushes, the first part 91 and the second part 92 of the initiating device 90 in a direction away from each other.

After reaching the release position, the second part 92/main assembly 50 moves relative to the first part 91, in particular as a result of repulsion, and/or towards the container 10 to the insertion position/state by means of the drive spring 60.

Thus, in the insertion position/state, the drive spring 60 is preferably less tense/compressed, and/or further decompressed, and/or the spring chamber 93 is longer/less compressed, compared to the initial position/state, and/or the release position.

In the insertion position/state, the length of the drive spring 60 and/or the spring chamber 93 increases, compared with the initial position/state and/or the release position, preferably by at least 0.1 mm or 0.3 mm, and/ or at most by 2 mm or by 1 mm, in particular by at least substantially 0.5 mm.

In preferred embodiments, the length of the drive spring 60 and/or the spring chamber 93 in the insertion position/state corresponds to the second and/or intermediate length L2 (see FIG. 9), and preferably the second/intermediate length L2 is greater than the first/minimum length L1, preferably by the value of X1, as shown in Fig. 9, and/or by at least 0.1 mm or by 0.3 mm, and/or by at most 2 mm or by 1 mm, in particular by at least substantially 0.5 mm.

In other words, after reaching the release position, the drive spring 60 preferably pushes the main assembly 50, in particular the rod rod 51, further into the container 10, preferably at least 0.1 mm or 0.3 mm, and/or at most 2 mm or 1 mm, in particular at least substantially 0.5 mm, and/or until the main assembly 50, in particular the rod rod 51, most preferably the first stopper 51C, abuts/impacts (axially) the frame 83B and/or into the locking element 83D of the second drive portion 80, as seen in FIG. 10.

- 22 046799

Thus, in preferred embodiments, in the insertion position, the second drive part 80, in particular the frame 83B and/or the locking element 83D of the second drive part 80 (axially) engages with the main assembly 50, in particular with the rod rod 51, most preferably with its the first stopper 51C, as a result, further advancement of the main assembly 50 into the container 10 is blocked.

Further decompression/release of the drive spring 60/spring force/spring energy and/or advancement of the main assembly 50, in particular the rod rod 51, into the container 10 is prevented by the second drive part 80, in particular the frame 83B and/or the locking element 83D of the second drive part 80, which is engaged with the main assembly 50, in particular with the rod rod 51, most preferably with its first stopper 51C, axially and/or abutting each other.

As already indicated, the second driving part 80 can be directly engaged in the insertion position/state.

In preferred embodiments, due to the (stepped) rear portion 51B of the rod shaft 51, the locking member 83E of the second drive portion 80 preferably no longer interacts with/relies on the rod shaft 51 in the injection position/state.

In preferred embodiments, the frame 83B and/or the locking element 83E of the second drive part 80, on the one hand, and the rod 51 of the main assembly 50, in particular the rear part 51B, on the other hand, are radially spaced at a certain distance from each other, in particular such that the second driving part 80, in particular its button 84, can be operated, in particular pressed, in the insertion position/state, as best shown in FIG. 10.

That is to say, in preferred embodiments, the rod rod 51 does not prevent the second drive portion 80 from being activated, in particular pressing the button 84, in the insertion position/state. By actuating the second drive part 80, in particular by pressing the button 84, the fluid 11 can be injected and/or the main assembly 50 and/or the plug 18 can be moved to the final position.

By actuating, in particular pressing, the second driving part 80, in particular its button 84, the second driving part 80, in particular its second end 83, is rotated about the rotation axis P and/or is at least substantially moved relative to the main assembly 50 and/or away from it, in particular such that the locking element 83D is (axially) disengaged from the main assembly 50, in particular its first stopper 51C, and/or the drive spring 60/spring force/spring energy ( again) can be expanded, and/or (additionally) released, and/or move the main assembly 50, in particular its rod rod 51, further into the container 10.

The second drive part 80 can be actuated, in particular by pressing the button 84, preferably until the locking element 83E (again) engages/butts radially against the main assembly 50, in particular the rod rod 51. Thus, in preferred embodiments, in the final position/state, the locking element 83E (again) radially abuts/engages with the main assembly 50, in particular the rod rod 51, thereby preventing the second drive portion 80 from being further pressed.

In fig. 11 and fig. 12 shows the insertion device 100 in its final position/state, that is, after the second drive part 80 has been activated.

In preferred embodiments, the end position is the (axial) position of the main assembly 50 and/or plug 18 relative to the frame 20 and/or container 10 (immediately) after injection and/or after (full) actuation of the second drive part 80 and/or in the final state of the insertion device 100.

In the final state of the injection device 100, and/or when the main assembly 50 and/or the plug 18 are/are in the final position, the fluid 11 is injected, the second drive portion 80 is (fully) actuated, and/or at least drive spring 60 is partially (additionally) released.

In the final state/position, the main assembly 50, the plug 18 and/or the second part 92 are located closer to the outlet of the insertion device 100 and/or further from the first driving part 70 and/or from the first part 91, and/or inserted/ inserted further into the container 10 compared to the initial state/position and/or the insertion state/position.

In preferred embodiments, in the final position/state, the second part 92/main assembly 50 is moved further, in particular pushed, away from the first part 91 by the drive spring 60 compared to the insertion state/position.

In the final position/state, the drive spring 60 is less tense/compressed, and/or further decompressed, and/or the spring chamber 93 is longer/less compressed, compared to the initial position/state, and/or the injection position/state.

In the final position/state, the length of the drive spring 60 and/or the spring chamber 93 (optional) increases compared to the injection position/state, preferably by

- 23 046799 by at least 1 mm or 2 mm, and/or at most by 10 mm or 8 mm, in particular by at least substantially 5 mm.

In preferred embodiments, the length of the drive spring 60 and/or the spring chamber 93 in the final position/state corresponds to the third and/or intermediate length L3 (see FIG. 11), and preferably the third/intermediate length L3 is greater than the first/minimum length L1 and/or second/intermediate length L2, preferably by the amount X2, as shown in FIG. 11, and/or by at least 1 mm or by 2 mm, and/or by at most by 10 mm or by 8 mm, in particular by at least substantially 5 mm.

In other words, upon actuation of the second drive part 80, the drive spring 60 preferably pushes the main assembly 50, in particular the rod rod 51, further into the container 10, preferably at least 1 mm or 2 mm, and/or at most 10 mm or 8 mm, in particular at least substantially 5 mm, and/or until the main assembly 50, in particular the rod rod 51, most preferably the second stopper 51D, abuts/impacts (axially) the frame 83B and/ or into the blocking member 83D of the second drive portion 80, thereby preventing the main assembly 50 from further moving into the container 10.

Thus, in accordance with one aspect of the present invention, the drive spring 60/spring force/spring energy can be at least partially expanded/released by actuating, in particular rotating, the first drive portion 70 and/or can be at least partially decompressed/released by actuating, in particular pressing, the second driving part 80. Thus, in preferred embodiments, the energy stored in the pre-stressed driving spring 60 is released in two steps and/or by actuating the first driving part 70 and then second drive part 80.

Thus, the usability of the injection device 100 is improved, and the transition from the initial state/position to the injection state/position and to the final state/position is facilitated.

In accordance with another aspect of the present invention, the axial movement of the main assembly 50 is limited by means of the second driving part 80, in particular by its locking element 83D, in both the insertion position/state and the end position/state.

The use of the (same) locking element 83D to block the axial movement of the main assembly 50 after initialization and injection improves dosing accuracy and accordingly minimizes product manufacturing requirements.

In preferred embodiments, in the final position/state, the position and/or angle of rotation of the second drive portion 80 (again) is at least substantially fixed and/or limited by a frame 83B that engages/abuts the main assembly 50, in particular the rod 51 rod, on both sides, in Fig. 12 below and above.

In particular, the position and/or rotation angle of the second drive portion 80 is preferably at least substantially fixed and/or limited in its final state/position by a locking element 83E engaged/supported by the main assembly 50, in particular the rod rod 51 , on the one hand, in Fig. 12 from below, and by means of a locking element 83D engaged/supported by the main assembly 50, in particular the rod rod 51, on the other hand, in FIG. 12 from top.

Further with references to Fig. 13-15, the mechanical interaction between the main assembly 50 and the indicator portion 40 will be described.

In fig. 13 is a partial cross-sectional perspective view of the insertion device 100 in its initial state. In fig. 14 is a partial cross-sectional perspective view of the insertion device 100 in an insertion state. In fig. 15 is a partial cross-sectional perspective view of the insertion device 100 in a final state. As already indicated, the main assembly 50, in particular its intermediate part 52, most preferably the pin 52A/52B, preferably fits radially into the indicator part 40, in particular into its axial hole 41A/41B and/or into the spiral slot/surface 42A/42B , and/or is axially engaged with it, most preferably only after reaching the insertion position/state and/or during movement from the insertion position/state to the final position/state.

Axial movement of the main assembly 50, in particular its pin 52A/52B, is most preferable after reaching the insertion position, which preferably causes rotation of the indicator portion 40, in particular about and/or relative to the main assembly 50, in particular relative to the intermediate portion 52. Thus , the rotation angle of the indicator part 40 is associated with the axial position of the main unit 50.

In preferred embodiments, the indicating means of the main assembly 50, in particular the pin 52A/52B, and the indicating part 40, in particular its indicating means 43, are visible from the outside and/or through the housing window 36.

In preferred embodiments, the indicating means of the main assembly 50, in particular the pin 52A/52B, moves axially within the preferably elongated housing window 36, in particular

- 24 046799 from one end to the other end of the casing window 36, in FIG. 13-15 from top to bottom.

Thus, the position of the indicating means of the main assembly 50, in particular the pin 52A/52B, within the housing window 36 directly indicates the axial position of the main assembly 50 and/or plug 18, in particular the initial position, release position, insertion position and/or end position.

The housing 30, in particular the housing window 36, may be provided with a label, mark or similar indicator corresponding to the initial position, the release position, the insertion position and/or the final position, such that the position of the indicating means of the main assembly 50, in particular the pin 52A/52B, relative to a label, mark or similar indicator indicates the position of the main assembly 50 and/or plug 18.

The indicator portion 40, in particular its indicating means 43, preferably moves substantially transversely relative to the longitudinal direction of the (elongated) housing window 36, thereby preferably providing an indication of the status of the insertion device 100 and/or the axial position of the main assembly 50 and/or plug 18 , in particular the initial position, the release position, the insertion position and/or the final position.

In the most preferred embodiments, the indicator portion 40, in particular its indicating means 43, is adapted to indicate the state of the insertion device 100 and/or the axial position of the main assembly 50 and/or plug 18, in particular when a final state/position has been reached.

In the present embodiment, the indicating means 43 is in the form of an elongated mark, preferably of a contrasting color, which enters substantially transversely into the housing window 36 when the end position/state is reached.

In this way, usability is improved and the risk of misoperation due to possible misunderstanding of the status of the administration device 100 is reduced.

In addition, the indicator portion 40 limits the visibility of the interior portions of the insertion device 100, particularly through the housing window 36, causing the user/practitioner's attention to be focused on the indicator portion 40 and/or the indicating means of the main assembly 50, particularly its pin. 52A/52B.

A preferred method of using the delivery device 100 preferably includes at least one of the following steps:

(manual) actuation, in particular by rotation, of the first drive part 70, which causes axial movement of the main assembly 50, plug 18, drive spring 60 and/or initiating device 90 relative to the frame 20 and/or relative to the container 10, in particular by means of the actuator lead screw, most preferably by means of the screw thread 94 of the initiating device 90 engaging the screw thread 76 of the first drive part 70, and/or (manual) actuating, in particular by rotation, the first drive part 70, in particular until the position is reached release of the main assembly 50, thereby releasing the second part 92, in particular the threaded part 92E, and/or partially decompressing/releasing the drive spring 60/spring force/spring energy, in particular such that the first part 91 and the second part 92 of the initiating device 90 are moved away from each other by the action of the drive spring 60, and/or the initialization is completed automatically and/or by the elastic force/energy of the drive spring 60, and/or (manual) actuation, in particular by pressing, of the second drive part 80 , in particular its buttons 84, causing the locking element 83D of the second drive part 80 to disengage (in the axial direction) from the main assembly 50, and/or (again) at least partially (further) decompress/release the drive spring 60/ elastic spring force, particularly such that the main assembly 50 and/or plug 18 moves from the insertion position to the end position automatically and/or under the action of the elastic force/energy of the drive spring 60.

As already indicated, the injection device 100 may be adapted for injection in the field of ophthalmology. In one embodiment, the administration device 100 is suitable for injection into the eyeball and has a suitably small volume for this purpose.

The delivery device 100, in particular the container 10, may also contain no silicone or substantially no silicone, or may contain minor amounts of silicone for use as a lubricant. In one embodiment, the administration device 100 and/or container 10 may meet the requirements of USP789.

The administration device 100, in particular the container 10, can be filled with any liquid drug 11 suitable for injection.

In one embodiment, the administration device 100, in particular the container 10, is filled with a fluid 11, in particular a drug suitable for injection, which contains an active component for the treatment of eye diseases. Examples of eye diseases include choroidal neovascularization, age-related macular degeneration (wet and dry forms), macular edema,

- 25 046799 resulting from retinal vein occlusion, including branch retinal vein occlusion and central retinal vein occlusion, choroidal neovascularization resulting from pathological myopia, diabetic macular edema, diabetic macular ischemia, geographic atrophy, diabetic retinopathy and proliferative retinopathy.

In one embodiment, the fluid 11, in particular the injectable drug, contains a biological active ingredient. The biological active ingredient may be an antibody (or fragment thereof) or a non-antibody protein. In one embodiment, the fluid 11, particularly the injectable drug, contains a VEGF antagonist, a multispecies anti-VEGF/Ang2 antibody or fragment thereof, a multispecies anti-VEGF/AngPT2 antibody or fragment thereof, a multispecies anti-VEGF/TrkB agonist, or a multispecies C3-inhibitor. anti-VEGF/APL-2 complement such as ranibizumab, bevacizumab, aflibercept, brolucizumab, conbercept (KH902) and the related glycoform KH906, farcinab or pazopanib.

Certain aspects and features of the present invention and individual method steps and/or method variations can be implemented independently of each other, as well as in any combinations and/or in any order.

In particular, the present invention also relates to any of the following aspects, which may be implemented independently or in any combination, as well as in combinations with any of the above aspects:

1. A device (100) for introducing, in particular for conducting a fluid medium (11) into the vitreous body of the eye, wherein the device (100) for introducing contains:

a frame (20) in which a container (10) containing a fluid (11) can be held, and an actuator containing a main unit (50) acting on a plug (18) located inside the container (10) with the possibility of movement, driving a spring (60) acting on the main assembly (50), the first drive part (70) and the second drive part (80), the first drive part (70) and the second drive part (80) being movably attached to the frame (20) , characterized in that the actuator includes a lead screw, wherein the first drive part (70) can be rotated to axially move the main assembly (50) and/or the drive spring (60) by means of the lead screw, and/or the drive spring (60) can be partially released by actuating the first driving part (70) and at least partially can be released by actuating the second driving part (80), and/or the first driving part (70) can be activated to move the main assembly ( 50) and/or the drive spring (60) from the rest position to the release position, the actuator comprising a locking element (77) configured to prevent the release of the drive spring (60) when the main assembly (50) and/or the drive spring (60) moves ) from the release position to the release position and to partially release the drive spring (60) upon reaching the release position, and/or the second drive portion (80) may be actuated to at least partially release the drive spring (60) and move the main assembly (50) from the insertion position to the end position, the actuator comprising a locking element (83D) configured to lock the main assembly (50) in the axial direction at both the insertion position and the end position, and/or a device (100) for insertion device comprises an indicator portion (40) indicating the state of the insertion device (100) and/or the axial position of the main assembly (50), wherein the indicator portion (40) can be rotated by axial movement of the main assembly (50).

2. An insertion device, preferably in accordance with aspect 1, characterized in that the actuator is configured to move the main assembly (50) from a home position to an insertion position during the initialization of the insertion device (100), and/or by actuation the first driving part (70), and from the injection position to the final position during subsequent fluid injection (11), and/or by actuating the second driving part (80).

3. An insertion device, preferably in accordance with aspect 1 or aspect 2, characterized in that the first driving part (70) is configured to move the main assembly (50) and/or the driving spring from the resting position to the release position, in which the driving spring (60) is partially released so that the main assembly (50) moves from the release position to the insertion position, in particular automatically and/or solely under the action of the drive spring (60).

4. An insertion device, preferably in accordance with any of the previous aspects, characterized in that the first drive part (70) can only be rotated in one direction, and/or the insertion device (100) includes a device that prevents reverse rotation, in particular a ratchet mechanism for the first driving part (70), and/or an insertion device (100)

- 26 046799 contains a backstop, in particular a ratchet mechanism, for the main assembly (50).

5. An insertion device, preferably in accordance with any of the previous aspects, characterized in that the actuator comprises an initiating device (90) which is movable relative to the frame (20) in an axial direction, the initiating device (90) comprising a first portion ( 91) and a second part (92), which are preferably releasably connected to each other axially, and/or the second part (92) is connected to or formed by the main assembly (50), in particular its end part (53).

6. An insertion device, preferably in accordance with aspect 5, characterized in that the drive spring (60) is located at least partially inside the initiating device (90), and/or the initiating device (90), in particular its first part (91 ), the second part (92) and/or the drive spring (60) is located at least partially inside the first drive part (70), at least in the initial state of the insertion device (100), and/or the drive spring (60 ) is configured to move the first part (91) and the second part (92) away from each other.

7. An insertion device, preferably in accordance with aspect 5 or aspect 6, characterized in that the actuator comprises a lead screw, a first driving part (70) and an initiating part (90), in particular its first part (91) and second part (92), interact with each other in a movable manner using a lead screw, and/or the first driving part (70) can be rotated to axially move the initiating device (90), in particular its first part (91) and second part (92 ), and/or the drive spring (60), in particular together with each other and/or as a whole.

8. An insertion device, preferably in accordance with aspects 5-7, characterized in that the initiating device (90), in particular its first part (91) and second part (92), contains/contains in particular an external screw thread (94 ), and the first driving part (70) includes in particular an internal screw thread (76), wherein the screw thread (94) of the initiating device (90) and the screw thread (76) of the first driving part (70) interact with each other.

9. An insertion device, preferably in accordance with any of the previous aspects, characterized in that the first driving part (70) contains a locking element (77), in particular in the form of an internal screw thread (76), and/or holds together the first part (91) and the second part (92) in the axial direction only until the release position is reached, and/or the locking element (77) can be released by actuating the first driving part (70).

10. An insertion device, preferably in accordance with any of the previous aspects, characterized in that the second driving part (80) contains or forms a frame (83B), and the main assembly (50), in particular the rod rod (51), passes through frame (83B).

11. An insertion device, preferably in accordance with any of the previous aspects, characterized in that the second drive part (80), in particular the frame (83B), contains or forms a locking element (83D) which is configured to lock the main assembly (50 ) in the axial direction after partial release of the drive spring (60) by the first drive part (70), and/or upon reaching the insertion position, and/or the locking element (83D) is configured to lock the main assembly (50) in the axial direction after at least as the drive spring (60) is partially released by the second drive part (80) and/or when the end position is reached.

12. An insertion device, preferably in accordance with any of the previous aspects, characterized in that the main assembly (50), in particular the rod rod (51), contains or forms a first stopper (51C) and/or a second stopper (51D), wherein the locking element (83D) is adapted for axial engagement with the first stopper (51C) in the insertion position and/or after completion of the initialization process, and/or for axial engagement with the second stopper (51D) in the final position and/or after completion of insertion.

13. An insertion device, preferably in accordance with any of the previous aspects, characterized in that the main assembly (50), in particular the intermediate part (52), contains at least one indicating means, which is preferably visible from the outside of the device (100) for introduction.

14. An insertion device, preferably in accordance with any of the previous aspects, characterized in that the indicator portion (40) includes at least one spiral slot and/or surface (42A, 42B).

15. An insertion device, preferably in accordance with aspect 13 and aspect 14, characterized in that the main assembly (50) fits radially into and/or axially engages the slot and/or surface (42A, 42B) such that axial movement of the main assembly (50) rotates the indicator portion (40), preferably only while moving the main assembly (50) from the insertion position to the end position.

16. Device (100) for introduction, preferably in accordance with any of the previous rules

- 27,046,799 pects, in particular for injection into the vitreous body of the eye of a fluid (11), wherein the injection device (100) contains:

a frame (20) in which a container (10) containing a fluid (11) can be held, and an actuator comprising a main assembly (50) acting on a plug (18) disposed movably inside the container (10), preferably a pre-stressed/compressed drive spring (60) acting on the main assembly (50), the first drive part (70) and the second drive part (80), the first drive part (70) and the second drive part (80) being preferably attached to the frame (20) movably, and/or the first drive part (70) is preferably axially attached to the frame (20) and/or can be rotated (manually) relative to the frame (20), and/or the second drive part (80) is preferably radially attached /transversely attached to the frame (20) and/or can be rotated/pressed (manually) relative to the frame (20), and/or the actuator preferably comprises a lead screw, the first drive part (70) and the main assembly (50) preferably ( directly) movably interact with each other and/or are (directly) movably connected to each other by a lead screw, and/or the first drive part (70) can be rotated (manually) to axially move the main assembly (50) and /or the (compressed) drive spring (60) by means of the lead screw, in particular from the resting position to the release position, and/or the drive spring (60)/spring force/spring energy can preferably be partially decompressed/released by actuating the first driving part (70) and can at least partially be decompressed/released by actuating the second driving part (80), and/or the first driving part (70) can preferably be activated (manually), in particular rotated relative to the frame (20), for (axial) movement of the main assembly (50) and/or the (compressed) drive spring (60) from the initial position to the release position, and/or by means of a lead screw, and/or the actuator preferably includes a locking element (77 ) configured to prevent the drive spring (60) from being released while the main assembly (50) and/or the (compressed) drive spring (60) is moving from the rest position to the release position, and/or to release the drive spring (60) when the position is reached release, and/or preferably at the release position and/or upon reaching the release position, and after release, the drive spring (60) preferably moves/pushes the main assembly (50) in the axial direction and/or from the release position to the insertion position, and/ or until the main assembly (50) abuts/impacts in the axial direction against the locking element (83D) of the second driving part (80), in particular such that the insertion device (100) is initialized and/or the second driving part (80 ) can preferably be (manually) actuated, in particular pressed (into the housing 30), such that the second driving part (80), in particular its locking element (83D), is disengaged (in the axial direction) with the main assembly (50), in particular with its first stop (51C), and/or such that the drive spring (60) is (again) released and/or can be expanded (further) and/or moved the main assembly (50) from the insertion position to the final position, in particular automatically, preferably pushing out the fluid (11), and/or the actuator preferably includes a locking element (83D) configured to lock the main assembly (50) in the axial direction, both in the insertion position and in the final position, and/or the insertion device (100) preferably includes an indicator portion (40) indicating the state of the insertion device (100) and/or the axial position of the main assembly (50), wherein the indicator portion (40) can be rotated by an axial movement of the main unit (50).

17. An injection device (100), preferably in accordance with any of the previous aspects, in particular for injecting a fluid (11) into the vitreous body of the eye, the injection device (100) comprising:

a frame (20) in which a container (10) containing a fluid (11) can be held, and an actuator comprising a main assembly (50) acting on a plug (18) disposed movably inside the container (10), preferably a pre-stressed/compressed drive spring (60) acting on the main assembly (50), the first drive part (70) and the second drive part (80), the first drive part (70) and the second drive part (80) being preferably attached to the frame (20) movably, and/or the first drive part (70) is preferably axially attached to the frame (20) and/or can be rotated (manually) relative to the frame (20), and/or

- 28 046799 the second driving part (80) is preferably radially/transversely attached to the frame (20) and/or can be rotated/pressed (manually) relative to the frame (20), and/or the first driving part (70) can preferably be driven in action (manually), in particular rotated relative to the frame (20), to (axially) move the main assembly (50) and/or the (compressed) drive spring (60) from the rest position to the release position, and/or by means of a lead screw and/ or engagement in a helical groove of the main assembly (50) with the first driving part (70), and/or the actuator preferably includes a locking element (77) configured to prevent release of the drive spring (60) during movement of the main assembly (50) and/ or the (compressed) drive spring (60) from the release position to the release position, and/or to release the drive spring (60) upon reaching the release position, and/or preferably at the release position and/or upon reaching the release position, and after release, the drive spring (60) preferably moves/pushes the main assembly (50) axially and/or from a release position to an insertion position, and/or until the main assembly (50) abuts/impacts axially against the locking element (83D) the second driving part (80), in particular such that the insertion device (100) is initiated and/or the second driving part (80) can preferably be (manually) actuated, in particular pressed (into the housing 30), such that such that the second drive part (80), in particular its locking element (83D), disengages (in the axial direction) from the main assembly (50), in particular its first stopper (51C), and/or in such a way that the drive spring (60) is (again) released and/or can be released (optional) and/or moves the main assembly (50) from the insertion position to the end position, in particular automatically, preferably introducing fluid (11).

List of reference designations

100 insertion device 34 second axial hole of the casing 35 radial hole (casing) 10 container 36 casing window eleven fluid 12 main building 40 indicator part 13 first axial end 41A 1st axial hole ind. parts 14 second axial end 41B 2nd axial hole ind. parts 15 locking part 42A first spiral slot 16 connector 42V second spiral slot 17 cap 43 indicator 18 cork 19 needle 50 main node 51 rod rod 20 frame 51A front end 21 installation part 51B rear end 21A nest (frame) 51C first stopper 21B retainer 51D second stopper 22 frame (frame) 51E reverse stopper

- 29 046799

22A receiving part (frame) 52 intermediate part 22V axial hole (frame) 52A first pin 22C fixing element 52V second pin 22D 22E reverse stopper, rotation (frame) drive stopper 53 end part 22F 22G lower part (frame) hole (frame) 60 drive spring 22N first recess 70 first drive part 22J second recess 71 pen 23 rotation pin 72 collar 24 reverse stopper, travel (frame) 73 74 connector (1st drive part) reverse rotation stopper (1st drive part) thirty casing leading part) 31 first part of the casing 75 receiving part 32 second part of the casing 76 screw thread 33 first ax. casing hole 77 fixing element 80 second driving part A main axis 81 socket (2nd drive, part) D distance 82 first end (2nd drive, part) L1 first length 83 second end (2nd drive, part) L2 second length 83A drive spring L3 third length 83B frame (2nd drive, part) R rotation axis 83С hole R axis of rotation 83D blocking element XI magnitude of difference 83E 84 85 90 91 91A 91B 91С 91D 91E 91F 91G 92 92A 92V 92С 92E 92G 93 94 blocking element button spacer initiating device (ID) first part back part (1st part of PS) wall (IS) seal springs (1st part of DUT) spring pin (1st part of DUT) threaded part (1st part of DUT) slot (1st part of DUT) groove (1st part of DUT) second part of DUT back part (2nd part of the PS) wall (2nd part of the PS) seal springs (2nd part of the control unit) threaded part (2nd part of the control device) protrusion (2nd part of the control device) spring chamber screw thread X2 magnitude of difference

-

Claims (20)

CLAIM 1. Device (100) for introducing fluid (11), containing: a frame (20) configured to hold a container (10) containing a fluid (11), and an actuator containing a main unit (50) acting on a plug (18) movably located inside the container (10), driving a spring (60) acting on the main assembly (50), the first drive part (70) and the second drive part (80), the first drive part (70) and the second drive part (80) being movably attached to the frame (20) , and the first driving part (70) is attached to the frame (20) in the axial direction with the possibility of rotation relative to the frame (20), characterized in that the first driving part (70) is configured to be actuated to move the main assembly (50) and drive spring (60) together with each other from the initial position to the release position, and the actuator includes a locking element (77) configured to prevent release/unclamping of the drive spring (60) when the main assembly (50) and the drive spring (60) are moved ) from the release position to the release position and at least partially release/decompress the drive spring (60) upon reaching the release position, so that the main assembly (50) moves from the release position to the insertion position under the action of the drive spring (60), and the second drive part (80) includes a locking element (83D) configured to lock the main assembly (50) in the axial direction when the insertion position is reached, the second driving part (80) being operable to at least partially release/unclamp the driving part spring (60) and movement of the main assembly (50) from the insertion position to the end position. 2. The insertion device according to claim 1, characterized in that the actuator is configured to move the main assembly (50) from the initial position to the insertion position during the initialization of the insertion device (100) and/or by actuating the first driving part (70), and from the insertion position to the final position during the subsequent introduction of the fluid (11) and/or by actuating the second drive part (80). 3. The insertion device according to any of the previous paragraphs, characterized in that the first driving part (70) is configured to move the main assembly (50) and/or the drive spring (60) from the initial position to the release position, in which the drive spring ( 60), at least partially, is released/unclamped so that the main assembly (50) moves from the release position to the insertion position, and/or until the main assembly (50) abuts/impacts in the axial direction against the locking element (83D) of the second driving part (80), in particular automatically and/or solely under the action of the driving spring (60). 4. Insertion device according to any of the previous paragraphs, characterized in that the first driving part (70) is rotatable in one direction only, and/or the insertion device (100) contains a device that prevents reverse rotation, in particular a ratchet mechanism , for the first drive part (70), and/or the insertion device (100) contains a backstop, in particular a ratchet mechanism, for the main assembly (50). 5. The insertion device according to any of the previous paragraphs, characterized in that the actuator includes an initiating device (90) configured to move relative to the frame (20) in the axial direction, wherein the initiating device (90) contains a first part (91) and a second portion (92), which are preferably axially releasably connected to each other, and/or a second portion (92) is connected to or formed by the main assembly (50), in particular its end portion (53). 6. Insertion device according to claim 5, characterized in that the drive spring (60) is located at least partially inside the initiating device (90), and/or the initiating device (90), in particular its first part (91) , the second part (92) and/or the drive spring (60) is located at least partially inside the first drive part (70), at least in the initial state of the insertion device (100), and/or the drive spring ( 60) is configured to move the first part (91) and the second part (92) away from each other. 7. Insertion device according to claim 5 or 6, characterized in that the actuator comprises a lead screw, a first driving part (70) and an initiating part (90), in particular its first part (91) and second part (92) , configured to interact with each other with movement through a lead screw, and/or the first driving part (70) is rotatable for axial movement of the initiating device (90), in particular its first part (91) and second part (92) , and/or the drive spring (60), in particular together with each other and/or as a whole. 8. Injection device according to any one of claims 5 to 7, characterized in that the initiating device (90), in particular its first part (91) and second part (92), contains/contains, in particular, an external - 31 046799 screw thread (94), and the first driving part (70) comprises, in particular, an internal screw thread (76), wherein the screw thread (94) of the initiating device (90) and the screw thread (76) of the first driving part (70 ) interact with each other. 9. An insertion device according to any one of claims 5 to 8, characterized in that the first part (91) and the second part (92) are in rotational engagement with each other, so that the first part (91) and the second part (92) cannot be rotated relative to each other, in particular at least until the insertion position is reached. 10. An insertion device according to any one of claims 5 to 9, characterized in that the first part (91) and the second part (92) are configured to come out of rotational engagement with each other when the insertion position is reached, such that the first part (91) and the second part (92) can be rotated relative to each other. 11. Device for administration according to any one of paragraphs. 5-10, characterized in that, upon reaching the insertion position, the first part (91) is able to move, in particular rotate, back into the first drive part (70) and/or in its direction by means of a drive spring (60), most preferably while the first part (91) and second part (92) will not reengage with each other, and/or until the first part (91) hits the corresponding stop of the second part (92). 12. An insertion device according to any of the previous paragraphs, characterized in that the first driving part (70) contains a locking element (77), which is in the form of a screw thread (76) and/or holds the first part (91) and the second part together (92) in the axial direction only until the release position is reached and/or the locking element (77) can be disengaged by actuating the first driving part (70). 13. The insertion device according to any of the previous claims, characterized in that the second driving part (80) contains or forms a frame (83B), and the main assembly (50), in particular the rod rod (51), passes through the frame (83B) . 14. The insertion device according to any of the previous paragraphs, characterized in that the second driving part (80), in particular the frame (83B), contains or forms a locking element (83D), which is configured to lock the main assembly (50) in an axial direction after at least partial release/decompression of the drive spring (60) by the first drive part (70), and/or upon reaching the insertion position, and/or the locking element (83D) is configured to lock the main assembly (50) in the axial direction after at least partial release/decompression of the drive spring (60) by means of the second drive part (80) and/or upon reaching the end position. 15. The insertion device according to any of the previous paragraphs, characterized in that the main assembly (50), in particular its rod rod (51), contains or forms a first stopper (51C) and/or a second stopper (51D), wherein the locking element (83D) is adapted for axial engagement with the first stopper (51C) in the insertion position and/or after completion of the initialization process, and/or for axial engagement with the second stopper (51D) in the final position and/or after completion of insertion. 16. An insertion device according to any of the previous claims, characterized in that the second driving part (80) is operable so that the second driving part (80) disengages from the main assembly (50) and/or so that the drive spring (60) is released and/or can be released and/or moves the main assembly (50) from the insertion position to the end position. 17. The insertion device according to any of the previous paragraphs, characterized in that it contains an indicator part (40) for indicating the state of the insertion device (100) and/or the axial position of the main assembly (50), wherein the indicator part (40) is made with the possibility of rotation through axial movement of the main unit (50). 18. The insertion device according to claim 17, characterized in that the main assembly (50), in particular its intermediate part (52), contains at least one, preferably arcuate, indicating means, which preferably extends along the indicator part ( 40) and/or is visible from the outside of the insertion device (100). 19. Insertion device according to claim 17 or 18, characterized in that the indicator part (40) contains at least one spiral or inclined slot and/or surface (42A, 42B). 20. An insertion device according to claim 18 or 19, characterized in that the main assembly (50) enters radially and/or axially engages the slot and/or surface (42A, 42B), so that the axial movement of the main assembly (50 ) rotates the indicator part (40), preferably only while moving the main assembly (50) from the insertion position to the end position. -