Injection device and injection solution transferring system

JP2025081554A5Pending Publication Date: 2025-10-28NOVARTIS AG
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Patent Information

Application Number
JP2025025963
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2019-12-12
Filing Date
2025-02-20
Publication Date
2025-10-28

AI Technical Summary

Technical Problem

Existing injection devices struggle to accurately and reliably administer micro-dose injection solutions, particularly when the required dose differs from the syringe's filling volume or when precise dosing is necessary.

Method used

The injection device features an injection solution container made of sterilized plastic, with a Luer taper for secure connection to a syringe, and a plunger with stop mechanisms to control the dosage, allowing for precise displacement and administration of micro-doses.

Benefits of technology

This solution enables accurate and reliable administration of micro-doses, ensuring precise control over the dosage and ease of use, particularly suitable for pediatric patients and ophthalmic applications.

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Abstract

To provide an injection device, in particular, a micro dose injection device such as, for example, an ophthalmic injection device.SOLUTION: An injection device 200 comprises: a rotatable plunger 204; a solution receptacle 202 having a first end configured to slidably receive the rotatable plunger and a second end configured to dispense solution contained in the solution receptacle; a first stop member 240 configured to prevent the rotatable plunger from being slidably displaced to a second position while the rotatable plunger is at a first position and in a first orientation; and a second stop member 242 configured to prevent the rotatable plunger from rotating in a first direction about the first axis while the rotatable plunger is at the first position and in the first orientation, wherein slidably displacing the rotatable plunger from the first position to the second position dispenses a specific quantity of the solution contained in the solution receptacle.SELECTED DRAWING: Figure 35a
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Description

Technical Field

[0001] Cross - reference to related applications This application claims priority to U.S. Provisional Patent Application No. 62 / 947,462, filed on December 12, 2019, entitled "INJECTION DEVICE AND INJECTION SOLUTION TRANSFERRING SYS TEM", the entire content of which is incorporated herein by reference for all purposes.

[0002] The present disclosure relates to injection devices, particularly micro - dose injection devices, such as ophthalmic injection devices for use in the eye, etc. Further, the present disclosure relates to an injection solution transfer system for transferring an injection solution from a syringe to such an injection device.

Background Art

[0003] Typically, an injection solution administered to a patient for a medical treatment is stored in a syringe having a container for containing the injection solution and a plunger displaceable relative to the container to discharge the injection solution from the container. When a medical treatment plan for a patient provides for the administration of a dose of the injection solution corresponding to the filling volume of the syringe, or when the dose of the injection solution is of low importance for the desired therapeutic effect, the injection solution may be administered directly from the syringe to the patient. However, when a medical treatment plan for a patient requires the administration of a dose of the injection solution different from the filling volume of the syringe and / or when an accurate dose of the injection solution is required, the injection solution may be transferred from the syringe to an injection device that is ultimately used to inject the desired dose of the injection solution into the patient's body before administration.

Summary of the Invention

Problems to be Solved by the Invention

[0004] The present disclosure aims to enable accurate and reliable administration of a micro-dose injection solution to a patient. An injection device is provided. Further, the present disclosure aims to provide an injection solution transfer system for transferring an injection solution from a syringe to this type of injection device.

Means for Solving the Problems

[0005] The injection device includes an injection solution container. The injection solution container and the protective outer barrel can be made of any suitable material, or a combination of materials including a plastic material, or glass. Suitable plastic materials include, for example, cycloolefin polymers or cycloolefin copolymers. An example of a glass material can be borosilicate glass. Preferably, the glass material does not contain tungsten. In one embodiment, the injection solution container can be non-coated. Non-coated means that the injection solution container does not contain any other material other than the material from which the injection solution container is made. Alternatively, the injection solution container may include an inner coating. The inner coating means a coating on the inner side of the injection solution container that contacts the injection solution. Examples of such inner coatings include a silicone coating or a fluorocarbon film made from a modified ethylene-tetrafluoroethylene copolymer. The injection solution container may not contain silicone, or may be substantially free of silicone, or may contain a low level of silicone as a lubricant. ​​​​​​​​​​​​​-ン may be included. Preferably, the injection solution container is made of a sterilized plastic material It is. Preferably, the injection solution container is made of a sterilized plastic material. Preferably, The injection solution container does not include an inner coating. In one embodiment, the injection solution container can meet USP789.

[0006] The injection solution container can be designed in the form of an inner injection solution container housed within a protective outer barrel It can be. An injection solution container designed in the form of an inner injection solution container can be integrally formed with the protective outer barrel The protective outer barrel can be provided with a flange element at the region of its proximal end to serve the role of connecting the protective outer barrel and the inner injection solution container to the housing of the injection device For example, the housing of the injection device can receive the flange element and thus can be provided with a container of suitable shape and dimensions for fastening the protective outer barrel and the inner injection solution container to the housing

[0007] At the distal end of the injection solution container of the injection device, a male part of a Luer taper can be provided to be adapted to interact with the female part of the Luer taper The female part of the Luer taper can be provided at the connection port of the adapter element of a filling adapter that can be used to connect the injection device to a syringe that houses the injection solution transferred from, for example, a syringe to the injection solution container of the injection device In this case, a luer thread can be provided, and the luer thread is adapted to interact with a complementary luer thread provided on the second connection port of the adapter element of the filling adapter, especially in the region of its outer periphery. As a result, a secure connection between the outer barrel of the injection device and the adapter element of the filling adapter can also be achieved. The injection device further comprises a plunger. The plunger can be made of polycarbonate. At least a part of the plunger is slidably received within the injection solution container. The plunger is displaceable distally relative to the injection solution container along the longitudinal axis of the plunger in order to expel the injection solution contained in the injection solution container from the injection solution container. The proximal end of the plunger, which can protrude proximally from the injection solution container, can support an activation button, and the activation button can be depressed by the user in order to displace the plunger distally relative to the injection solution container along the longitudinal axis of the plunger. The plunger can be provided at its distal end with a tip element that can be attached to the plunger rod. The connection between the plunger rod and the tip element can be made, for example, by the interaction between a tip catch provided at the distal end of the plunger rod and a catch receiver of the tip element. Furthermore, the tip element can be provided with a sealing element, which can be provided, for example, in the region of the outer peripheral surface of the tip element and which interacts to seal with the inner peripheral surface of the injection solution container.

[0008]

[0009] In the first dosing position, the plunger is in a distal position relative to the injection solution container in the distal direction. ​​​​​​​​​​​​​​​It further comprises a first plunger stop mechanism adapted to stop the displacement of the plunger. Furthermore, the injection device is configured to stop the displacement of the plunger in the distal direction from the first dosing position at the second dosing position, and comprises a second plunger stop mechanism. The first and second dosing positions of the plunger are selected such that when the plunger is displaced relative to the injection solution container between the first dosing position and the second dosing position, it is adapted to discharge the desired dose of the injection solution contained in the injection solution container from the injection solution container. After filling the injection solution container with the injection solution to be administered to the patient, the user of the injection device can discharge the excess injection solution from the injection solution container by displacing the plunger in the distal direction relative to the injection solution container until the plunger reaches the first dosing position.

[0010] When the first dosing position is reached, the first plunger stop mechanism stops any further displacement of the plunger in the distal direction. As a result, the user is prevented from discharging too much injection solution from the injection solution container. The remaining injection solution contained in the injection solution container can then be further displaced in the distal direction by the plunger until the plunger reaches the second dosing position and administered to the patient. When the second dosing position is reached, the second plunger stop mechanism stops any further displacement of the plunger in the distal direction, thereby preventing too much injection solution from being administered to the patient.

[0011] The present injection device enables accurate and reliable administration of a micro-dose of injection solution to a patient. Furthermore, the injection device can be easily and comfortably handled by the user. Therefore, the injection device is particularly suitable for treating pediatric patients. In particular, the injection device can be designed in the form of an ophthalmic injection device for use within the eye.

[0012] In one embodiment, the injection device is filled with an injection solution having a dosage volume of about 1 μL to about 50 μL, preferably about 10 μL to about 20 μL (i.e., the volume of the injection solution intended to be delivered to the patient ). In another embodiment, the injection device is filled with an injection solution having a dosage volume of 50 μL to 250 μL . In yet another embodiment, the injection device is filled with an injection solution having a dosage volume of 25 μL to 125 μL. In a preferred embodiment, the injection de vice is filled with an injection solution having a dosage volume of 5 μL, 10 μL, 20 μL or 30 μL .

[0013] The injection device can be filled with any injection solution, for example, an injectable drug. In one embodiment, the injection device is filled with an injectable drug containing an active ingredient suitable for the treatment of eye diseases. Examples of such eye diseases include retinopathy of prematurity, geographic atrophy, glaucoma , choroidal neovascularization, age-related macular degeneration (both exudative and atrophic), macular edema secondary to retinal vein occlusion (RVO )(including both branch RVO (bRVO) and central RVO (cRVO)), choroidal neovascularization secondary to pathologic myopia (PM), diabetic macular edema (DME), diabetic retinopathy, retinitis pigmentosa, Leber congenital amaurosis, Best vitelliform dystrophy, and proliferative retinopathy. In one embodiment, the drug contains a small molecule drug. In one embodiment , the drug contains a biologically active substance. The biologically active substance is an antibody (or a fragment thereof ) is a non-antibody protein, nucleic acid for gene therapy, or cell substance for cell therapy Obtained. In one embodiment, the agent comprises a VEGF inhibitor. Suitable VEGF inhibitors include ranibizumab (Lucentis TM ), bevacizumab (Avastin TM ), brolucizumab (Beovu®, also known as RTH258), aflibercept (Eylea ), also known as VEGF-Trap Eye), conbercept (International Publication No. WO 2005 / 121176, incorporated herein by reference, described as FP3 in the pamphlet, KH902 of Chengdu Kanghong Biotechnology Co., Ltd.), and related glycoforms TM KH906 or pazopanib (GlaxoSmithKline). technologies Co., Ltd.), and related glycoforms KH906 or pazopanib (GlaxoSmithKline).

[0014] In a preferred embodiment, the injection device is filled with 0.1 mg or 0.2 mg of ranibizumab in a 20 μL injection solution. In the most preferred embodiment, the injection device is filled with 20 μl of ranibizumab (0.2 mg) and used for the treatment of retinopathy of prematurity.

[0015] In a preferred embodiment of the injection device, the first plunger stop mechanism comprises a dosing element, the dosing element is attached to the plunger and adapted to abut against a first dosing surface provided on the housing element. Alternatively or in addition thereto, the second plunger stop mechanism can comprise a dosing element, the dosing element is attached to the plunger and adapted to abut against a second dosing surface provided on the housing element.

[0016] Preferably, the dosing element of the first and / or second plunger stop mechanism is integrally formed with the plunger. For example, the dosing element can be designed in the form of ribs that can protrude from the surface of the operating button of the plunger in the direction of the inner solution container. Basically, the injection device can be considered to comprise a first dosing element associated with the first plunger stop mechanism and a second dosing element associated with the second plunger stop mechanism. However, preferably, the injection device is provided with only one dosing element that is attached to the plunger and is associated with both the first and second plunger stop mechanisms. The single dosing element is adapted to first contact the first dosing surface when the plunger reaches the first dosing position during distal movement of the plunger, and then to contact the second dosing surface when the plunger reaches the second dosing position during further distal movement of the plunger from the first dosing position in the distal direction. The first and second dosing surfaces can be provided on different housing elements of the injection device. However, in a preferred embodiment of the injection device, the first and second dosing surfaces are both formed on the first housing element, i.e., the same housing element of the injection device. The first and second dosing surfaces preferably extend substantially parallel to each other, and the second dosing surface can be arranged parallel and offset distally with respect to the first dosing surface. The distance between the first dosing surface and the second dosing surface in the distal direction can correspond to the desired movement distance of the plunger in the distal direction between the first dosing position and the second dosing position. Thereby, by suitably arranging the first and second dosing surfaces, the desired plunger displacement between the first dosing position and the second dosing position can be achieved. When the plunger moves in the distal direction, it first contacts the first dosing surface when the plunger reaches the first dosing position, and then, when the plunger further moves in the distal direction from the first dosing position, it contacts the second dosing surface when the plunger reaches the second dosing position. When the plunger moves further in the distal direction from the first dosing position, it contacts the second dosing surface when the plunger reaches the second dosing position. When the plunger reaches the second dosing position, it contacts the second dosing surface.

[0017] The first and second dosing surfaces can be provided on different housing elements of the injection device. However, in a preferred embodiment of the injection device, the first and second dosing surfaces are both formed on the first housing element, i.e., the same housing element of the injection device. The first and second dosing surfaces preferably extend substantially parallel to each other, and the second dosing surface can be arranged parallel and offset distally with respect to the first dosing surface. The distance between the first dosing surface and the second dosing surface in the distal direction can correspond to the desired movement distance of the plunger in the distal direction between the first dosing position and the second dosing position. Thereby, by suitably arranging the first and second dosing surfaces, the desired plunger displacement between the first dosing position and the second dosing position can be achieved. The first and second dosing surfaces are preferably formed on the same housing element of the injection device, i.e., the first housing element. The first and second dosing surfaces preferably extend substantially parallel to each other, and the second dosing surface can be arranged parallel and offset distally with respect to the first dosing surface. The distance between the first dosing surface and the second dosing surface in the distal direction can correspond to the desired movement distance of the plunger in the distal direction between the first dosing position and the second dosing position. This allows for a suitable arrangement of the first and second dosing surfaces to achieve the desired plunger displacement between the first dosing position and the second dosing position. By suitably arranging the first and second dosing surfaces, the desired plunger displacement between the first dosing position and the second dosing position can be achieved. position, and thus the desired dosage of the injection solution to be discharged from the injection solution container when displacing the plunger from the first dosing position to the second dosing position can be set. The first and second dosing surfaces can extend substantially parallel to the abutment surface of the dosing element. For example, together with the first and second dosing surfaces, the abutment surface of the dosing element can extend substantially perpendicular to the longitudinal axis of the plunger. The first plunger stop mechanism is adapted to stop the displacement of the plunger at the first dosing position, but can be designed, for example, to provide a resistance force that can be overcome by increasing the actuating force acting on the plunger. However, in a particularly preferred embodiment of the injection device, the first plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., it is adapted to prevent the plunger from being displaced distally from the first dosing position relative to the injection solution container without damaging the first plunger stop mechanism. In particular, when the first plunger stop mechanism is designed as a hard stop for the plunger, the injection device preferably further comprises a plunger release mechanism, which is adapted to deactivate the first plunger stop mechanism in order to release the plunger and thus enable the displacement of the plunger relative to the injection solution container in the distal direction from the first dosing position, i.e., in the direction of the second dosing position. The second plunger stop mechanism is also configured to stop the displacement of the plunger at the second dosing position, but can be designed, for example, by increasing the actuating force acting on the plunger. The first and second dosing surfaces can extend substantially parallel to the abutment surface of the dosing element. For example, together with the first and second dosing surfaces, the abutment surface of the dosing element can extend substantially perpendicular to the longitudinal axis of the plunger. to extend.

[0018] The first plunger stop mechanism is adapted to stop the displacement of the plunger at the first dosing position, but can be designed, for example, to provide a resistance force that can be overcome by increasing the actuating force acting on the plunger. However, in a particularly preferred embodiment of the injection device, the first plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., it is adapted to prevent the plunger from being displaced distally from the first dosing position relative to the injection solution container without damaging the first plunger stop mechanism. In particular, when the first plunger stop mechanism is designed as a hard stop for the plunger, the injection device preferably further comprises a plunger release mechanism, which is adapted to deactivate the first plunger stop mechanism in order to release the plunger and thus enable the displacement of the plunger relative to the injection solution container in the distal direction from the first dosing position, i.e., in the direction of the second dosing position. to be overcome. However, in a particularly preferred embodiment of the injection device, the first plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., it is adapted to prevent the plunger from being displaced distally from the first dosing position relative to the injection solution container without damaging the first plunger stop mechanism. In particular, when the first plunger stop mechanism is designed as a hard stop for the plunger, the injection device preferably further comprises a plunger release mechanism, which is adapted to deactivate the first plunger stop mechanism in order to release the plunger and thus enable the displacement of the plunger relative to the injection solution container in the distal direction from the first dosing position, i.e., in the direction of the second dosing position. In a particularly preferred embodiment of the injection device, the first plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., it is adapted to prevent the plunger from being displaced distally from the first dosing position relative to the injection solution container without damaging the first plunger stop mechanism. In particular, when the first plunger stop mechanism is designed as a hard stop for the plunger, the injection device preferably further comprises a plunger release mechanism, which is adapted to deactivate the first plunger stop mechanism in order to release the plunger and thus enable the displacement of the plunger relative to the injection solution container in the distal direction from the first dosing position, i.e., in the direction of the second dosing position. In a particularly preferred embodiment of the injection device, the first plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., it is adapted to prevent the plunger from being displaced distally from the first dosing position relative to the injection solution container without damaging the first plunger stop mechanism. In particular, when the first plunger stop mechanism is designed as a hard stop for the plunger, the injection device preferably further comprises a plunger release mechanism, which is adapted to deactivate the first plunger stop mechanism in order to release the plunger and thus enable the displacement of the plunger relative to the injection solution container in the distal direction from the first dosing position, i.e., in the direction of the second dosing position. The first plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., it is adapted to prevent the plunger from being displaced distally from the first dosing position relative to the injection solution container without damaging the first plunger stop mechanism. In particular, when the first plunger stop mechanism is designed as a hard stop for the plunger, the injection device preferably further comprises a plunger release mechanism, which is adapted to deactivate the first plunger stop mechanism in order to release the plunger and thus enable the displacement of the plunger relative to the injection solution container in the distal direction from the first dosing position, i.e., in the direction of the second dosing position. The first plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., it is adapted to prevent the plunger from being displaced distally from the first dosing position relative to the injection solution container without damaging the first plunger stop mechanism. In particular, when the first plunger stop mechanism is designed as a hard stop for the plunger, the injection device preferably further comprises a plunger release mechanism, which is adapted to deactivate the first plunger stop mechanism in order to release the plunger and thus enable the displacement of the plunger relative to the injection solution container in the distal direction from the first dosing position, i.e., in the direction of the second dosing position. The first plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., it is adapted to prevent the plunger from being displaced distally from the first dosing position relative to the injection solution container without damaging the first plunger stop mechanism. In particular, when the first plunger stop mechanism is designed as a hard stop for the plunger, the injection device preferably further comprises a plunger release mechanism, which is adapted to deactivate the first plunger stop mechanism in order to release the plunger and thus enable the displacement of the plunger relative to the injection solution container in the distal direction from the first dosing position, i.e., in the direction of the second dosing position. The first plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., it is adapted to prevent the plunger from being displaced distally from the first dosing position relative to the injection solution container without damaging the first plunger stop mechanism. In particular, when the first plunger stop mechanism is designed as a hard stop for the plunger, the injection device preferably further comprises a plunger release mechanism, which is adapted to deactivate the first plunger stop mechanism in order to release the plunger and thus enable the displacement of the plunger relative to the injection solution container in the distal direction from the first dosing position, i.e., in the direction of the second dosing position. The first plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., it is adapted to prevent the plunger from being displaced distally from the first dosing position relative to the injection solution container without damaging the first plunger stop mechanism. In particular, when the first plunger stop mechanism is designed as a hard stop for the plunger, the injection device preferably further comprises a plunger release mechanism, which is adapted to deactivate the first plunger stop mechanism in order to release the plunger and thus enable the displacement of the plunger relative to the injection solution container in the distal direction from the first dosing position, i.e., in the direction of the second dosing position. The first plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., it is adapted to prevent the plunger from being displaced distally from the first dosing position relative to the injection solution container without damaging the first plunger stop mechanism. In particular, when the first plunger stop mechanism is designed as a hard stop for the plunger, the injection device preferably further comprises a plunger release mechanism, which is adapted to deactivate the first plunger stop mechanism in order to release the plunger and thus enable the displacement of the plunger relative to the injection solution container in the distal direction from the first dosing position, i.e., in the direction of the second dosing position. The first plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., it is adapted to prevent the plunger from being displaced distally from the first dosing position relative to the injection solution container without damaging the first plunger stop mechanism. In particular, when the first plunger stop mechanism is designed as a hard stop for the plunger, the injection device preferably further comprises a plunger release mechanism, which is adapted to deactivate the first plunger stop mechanism in order to release the plunger and thus enable the displacement of the plunger relative to the injection solution container in the distal direction from the first dosing position, i.e., in the direction of the second dosing position.

[0019] The second plunger stop mechanism is also configured to stop the displacement of the plunger at the second dosing position, but can be designed, for example, by increasing the actuating force acting on the plunger. However, in a particularly preferred embodiment of the injection device, the first plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., it is adapted to prevent the plunger from being displaced distally from the first dosing position relative to the injection solution container without damaging the first plunger stop mechanism. In particular, when the first plunger stop mechanism is designed as a hard stop for the plunger, the injection device preferably further comprises a plunger release mechanism, which is adapted to deactivate the first plunger stop mechanism in order to release the plunger and thus enable the displacement of the plunger relative to the injection solution container in the distal direction from the first dosing position, i.e., in the direction of the second dosing position. It can be designed to provide a resistance that can be overcome. However , in a particularly preferred embodiment, the second plunger stop mechanism is adapted to provide a hard stop for the plunger, i.e., to prevent the plunger from being displaced distally from the second dosing position relative to the injection solution container without damaging the second plunger stop mechanism. This allows the dose of the injection solution to be administered to the patient to be set in a particularly accurate manner. Preferably, the plunger release mechanism is adapted to allow movement of at least one of the dosing element and the first dosing surface in order to disengage the dosing element from the first dosing surface. The movement of the dosing element and / or the first dosing surface can be manually induced by the user of the injection device. In a particularly preferred embodiment of the injection device, it is sufficient for the user to move only the first dosing surface in order to disengage the dosing element from the first dosing surface. As a result, the user does not need to cause movement of the plunger in order to activate the plunger release mechanism. For example, it may be sufficient to move the housing element supporting the first dosing surface in order to activate the plunger release mechanism, while the plunger can remain in its position, thereby simplifying the use of the injection device. The plunger release mechanism can be adapted to allow a rotational movement of at least one of the dosing element and the first dosing surface in order to disengage the dosing element from the first dosing surface. For example, the plunger release mechanism can be activatable by a manually induced rotation of the plunger and / or the first dosing surface. In particular, the plunger release mechanism is activated by a manually induced rotation of the plunger release mechanism.

[0020] Preferably, the plunger release mechanism is adapted to allow movement of at least one of the dosing element and the first dosing surface to disengage the dosing element from the first dosing surface. The movement of the dosing element and / or the first dosing surface can be caused manually by the user of the injection device. In a particularly preferred embodiment of the injection device, it is sufficient for the user to move only the first dosing surface to disengage the dosing element from the first dosing surface. As a result, the user does not need to cause movement of the plunger to activate the plunger release mechanism. For example, it may be sufficient to move the housing element supporting the first dosing surface to activate the plunger release mechanism, while the plunger can remain in its position. This simplifies the use of the injection device. For example, to activate the plunger release mechanism, it may be sufficient to move the housing element supporting the first dosing surface, while the plunger can remain in its position. This simplifies the use of the injection device.

[0021] The plunger release mechanism can be adapted to allow a rotational movement of at least one of the dosing element and the first dosing surface to disengage the dosing element from the first dosing surface. For example, the plunger release mechanism can be activatable by a manually induced rotation of the plunger and / or the first dosing surface. In particular, the plunger release mechanism can be activatable by a manually induced rotation of the plunger and / or the first dosing surface. In particular, the plunger release mechanism is activated by a manually induced rotation of the plunger release mechanism. adapted to allow rotational movement of a housing element that supports a first dosing surface for movement The actuation of the rotational movement of the plunger and / or the first dosing surface, in particular only the first dosing surface, can be easily identified by the user from the pressing actuation of the plunger that moves the plunger in the distal direction. As a result, the use of the injection device is further simplified.

[0022] In a preferred embodiment of the injection device, the first and second dosing surfaces are offset from each other circumferentially of the plunger and are arranged, for example, on different or the same housing element. Therefore, the plunger release mechanism disengages the dosing element from the first dosing surface and simultaneously aligns the second dosing surface with the dosing element so that the dosing element abuts against the second dosing surface when the plunger reaches the second dosing position as the plunger is displaced distally from the first dosing position. The plunger release mechanism can be adapted to displace the first and second dosing surfaces circumferentially of the plunger. Such a design of the plunger release mechanism enables particularly simple and reliable handling of the injection device.

[0023] Preferably, the first and second dosing surfaces are formed on a first housing element that is rotatable relative to the plunger. When the first and second dosing surfaces are offset from each other on the first housing element circumferentially of the plunger, the disengagement of the dosing element from the first dosing surface and the simultaneous arrangement of the second dosing surface in a position ready to engage the dosing element can be easily achieved by simply rotating the first housing element by an appropriate amount when the plunger reaches the second dosing position as the plunger is displaced distally from the first dosing position. ​​​​​​​​​​​​

[0024] The second dosing surface may be defined by a bottom surface of a recess formed in the first dosing surface. Preferably, the recess is designed to allow a dosing element to be received in the recess. The plunger is disposed in the first dispensing position and the dispensing When the medication element abuts the first medication surface, a recess defined in the first medication surface contacts the first housing element. Through the rotational movement of the first The dosing element is received in the recess and the plunger is disengaged from the dosing surface. in the distal direction until the abutment surface formed thereon abuts a second dosing surface defined by a bottom surface of the recess. The distance between the first and second dosing surfaces in the distal direction The depth of the recess that defines the first and second dosing positions is determined by the distance in the distal direction between the first and second dosing positions. This allows the desired travel distance of the actuator to be accommodated.

[0025] A first housing element, which supports the first and second dosing surfaces, in particular in the region of its outer surface, is provided with a gripping mechanism. For example, the gripping structure may be adapted to accommodate the shape of the exterior surface of the first housing element. and a gripping member including individual gripping ribs extending in a direction substantially along the longitudinal axis of the plunger. The gripping structure can be designed in the form of a gripping rib arrangement. However, this is simplified.

[0026] Preferably, the plunger release mechanism is adapted to indicate activation of the plunger release mechanism. The marker system may, for example, be located in the area of ​​its outer surface. A first marker element is provided on a first housing element that supports the first and second dispensing surfaces. It can include. The marker system can further include a second marker element provided on the second housing element of the syringe, especially in the region of its outer surface. The first and second marker elements are positioned offset from each other in the circumferential direction of the plunger, for example, when the plunger release mechanism is not activated. However, when the plunger release mechanism is activated, the first and second housing elements can be arranged at positions where they are aligned with each other. The marker system provides the user with guiding information regarding how to activate the plunger release mechanism, thereby simplifying the handling of the injection device. It can include a second marker element provided on the second housing element of the syringe. When the plunger release mechanism is not activated, for example, the first and second marker elements are positioned offset from each other in the circumferential direction of the plunger. However, when the plunger release mechanism is activated, the first and second housing elements can be arranged at positions where they are aligned with each other. The marker system provides the user with guiding information regarding how to activate the plunger release mechanism, thereby simplifying the handling of the injection device. The injection device preferably further includes an activation mechanism. The activation mechanism is adapted to prevent the activation of the plunger release mechanism as long as the plunger is not placed in the first dosing position, and is adapted to enable the activation of the plunger release mechanism when the plunger is placed in the first dosing position. The activation mechanism can be adapted to prevent the dosing element and / or the first dosing surface from moving relative to each other as long as the plunger is not placed in the first dosing position.

[0027] In a preferred embodiment of the injection device, the activation mechanism includes a guiding channel provided on the circumferential surface of the plunger extending along the longitudinal axis of the plunger. The guiding element provided on the housing element is engaged with the injection solution container when the plunger is displaced. As long as the plunger is not placed in the first dosing position, the activation mechanism is adapted to prevent the activation of the plunger release mechanism. When the plunger is placed in the first dosing position, the activation mechanism is adapted to enable the activation of the plunger release mechanism. As long as the plunger is not placed in the first dosing position, the activation mechanism is adapted to prevent the dosing element and / or the first dosing surface from moving relative to each other. In particular, as long as the plunger is not placed in the first dosing position, the activation mechanism can be adapted to prevent the rotation of the first housing element supporting the first and second dosing surfaces relative to the plunger supporting the dosing element. In a preferred embodiment of the injection device, the activation mechanism includes a guiding channel provided on the circumferential surface of the plunger extending along the longitudinal axis of the plunger. The guiding element provided on the housing element is engaged with the injection solution container when the plunger is displaced. The activation mechanism can be adapted to prevent the rotation of the first housing element supporting the first and second dosing surfaces relative to the plunger supporting the dosing element as long as the plunger is not placed in the first dosing position.

[0028] In a preferred embodiment of the injection device, the activation mechanism includes a guiding channel provided on the circumferential surface of the plunger extending along the longitudinal axis of the plunger. The guiding channel is provided on the circumferential surface of the plunger extending along the longitudinal axis of the plunger. The guiding element provided on the housing element is engaged with the injection solution container when the plunger is displaced. The guiding element provided on the housing element is engaged with the injection solution container when the plunger is displaced. Accept in such a manner that the induction channel is displaced relative to the induction element. By the interaction between the induction element and the opposing surface of the induction channel, the plunger and the housing element can be prevented from rotating relative to each other. When the starting mechanism comprises an induction channel extending along the longitudinal axis of the plunger and a corresponding induction element, the starting mechanism enables, on the one hand, the induced displacement of the plunger in the direction of its longitudinal axis and, at the same time, serves a dual function of preventing the first plunger stop mechanism from inadvertently coming to a stop when the plunger is not in the first dosing position. The induction element can be provided on a first housing element that also supports the first dosing surface and preferably the second dosing surface. The starting mechanism can further comprise a starting channel branching off from the induction channel. For example, the starting channel can extend circumferentially of the plunger substantially perpendicular to the induction channel. The starting channel is preferably adapted to receive the induction element when the plunger is in the first dosing position and the first housing element, which also supports the induction element and preferably the first and second dosing surfaces, has rotated relative to the plunger. Such a design of the starting mechanism defines the first dosing position of the plunger by the position of the starting channel along the longitudinal axis of the plunger. The first and second dosing surfaces can be formed on a first housing element that is rotatable relative to the plunger. When the first and second dosing surfaces are offset from each other in the circumferential direction of the plunger on the first housing element, the disengagement of the dosing element from the first dosing surface

[0029]

[0030] ​​​​​​​​​​​​​​and the simultaneous arrangement of the second dosing surface at a position where the second dosing surface is ready to engage with the dosing element is such that when the plunger is displaced distally from the first dosing position, it reaches the second dosing position and can be easily achieved by simply rotating the first housing element by an appropriate amount of rotation.

[0031] The second dosing surface can be defined by the bottom surface of the recess formed in the first dosing surface. Preferably the recess is designed to allow the dosing element to be received in the recess, i.e. of such shape and dimensions. When the plunger is disposed in the first dosing position and the dosing element abuts against the first dosing surface, the recess formed in the first dosing surface can be aligned with the dosing element via the rotational movement of the first housing element. As a result, the dosing element is disengaged from the first dosing surface, and the plunger can be displaced further distally until the dosing element is received in the recess and the abutment surface formed on the dosing element abuts against the second dosing surface defined by the bottom surface of the recess.

[0032] The plunger release mechanism can further comprise a locking arrangement which is adapted to lock the first dosing surface in place relative to the dosing element after the first dosing surface has been moved relative to the dosing element to disengage from the dosing element. Thus, due to the locking arrangement, the plunger release mechanism can be used only once to stop the first plunger stop mechanism. As a result, reuse of the injection device is reliably prevented.

[0033] The locking arrangement can comprise an elastic locking clip which When the dosing surface moves relative to the dosing element such that it is disengaged from the dosing element, the locking element is adapted to be elastically pushed out from the rest position by interaction with the , for example. An elastic locking clip can be provided on the second housing element, but the locking element can be provided on the first housing element that supports the first dosing surface and optionally also the second dosing surface. Therefore, the elastic locking clip can be elastically deformed when the first housing element rotates relative to the second housing element. The locking clip is preferably also adapted to deform so as to return to its rest position after completion of the movement of the first dosing surface and to interact with the locking element so as to lock the first dosing surface in place relative to the dosing element. In particular, the locking clip is for disengaging the first dosing surface from the dosing element and for aligning the second dosing surface with the dosing element, and can interact with the locking element so as to prevent reverse rotation of the first housing element relative to the second housing element and the plunger after one rotation of the first housing element.

[0034] The injection device can further comprise a limiting mechanism that is adapted to limit the movement of the dosing element and / or both the first and second dosing surfaces in order to disengage the dosing element from the first dosing surface and to align the dosing element with the second dosing surface. The limiting mechanism prevents the user of the injection device from moving the dosing element and the first and second dosing surfaces relative to each other in an excessive manner. Further, the limiting mechanism ensures that the dosing element is properly disengaged from the first dosing surface and aligned with the second dosing surface, i.e., the first plunger stop Provide haptic feedback to the user that the stop mechanism has entered the stopped state.

[0035] The limiting mechanism can in particular comprise a first limiting element provided on a first housing element that supports the first and second dosing surfaces. Further, the limiting mechanism can comprise a second limiting element provided on a second housing element, the second housing element being adapted to remain stationary when the first housing element moves, in particular rotates, in order to bring the first plunger stop mechanism into the stopped state. The first limiting element can be adapted to abut against the second limiting element when the dosing element is disengaged from the first dosing surface and aligned with the second dosing surface.

[0036] If the injection device comprises the activation mechanism described above, including an activation channel and a guiding element formed in a first housing element that also supports the first and second dosing surfaces, the movement of the first dosing surface relative to the dosing element attached to the plunger can also be restricted by the interaction between the guiding element and the end face of the activation channel, the end face of the activation channel acting as an abutment surface for the guiding element when the first housing element has rotated relative to the plunger and the dosing element has been disengaged from the first dosing surface and aligned with the second dosing surface.

[0037] The injection device can further comprise a first drag mechanism adapted to apply a holding force that holds the plunger in its current position relative to the injection solution container. Thus, the first drag mechanism prevents the plunger from being displaced unintentionally relative to the injection solution container, or rather, the presence of the first drag mechanism, for example, by applying a pressing force, prevents the plunger from being displaced relative to the injection solution container.​​​​​​​​​​​​​​ Active manual actuation, effected by this, is necessary to displace the plunger relative to the injection solution container. The first drag mechanism can be provided, for example, on the second housing element. The first drag mechanism can comprise an elastic drag element. The elastic drag element can be adapted to exert an elastic holding force on the plunger. That is, the elastic drag element can elastically push the plunger from the rest position to the biasing position by interacting with the plunger, and due to its elasticity, an elastic reaction force can be applied to the plunger, by which the plunger is held in the current position. The elastic drag element can in particular interact with a drag rib, which is provided on the outer peripheral surface of the plunger and extends substantially parallel to the longitudinal axis of the plunger. As an alternative or in addition to this, the injection device can also comprise a second drag mechanism, which is adapted to apply a holding force that holds the first housing element in its current position, i.e., holds the first housing element in place relative to the second housing element. Thus, the second drag mechanism prevents the first housing element from being displaced unintentionally relative to the second housing element, and thus prevents the first plunger stop mechanism from unintentionally coming to a stop. The second drag mechanism can comprise a friction element, which is provided on the first limiting element of the limiting mechanism and is adapted to interact with the holding element of the second housing element.

[0038] The injection device can further comprise a plunger positioning mechanism, which is adapted to displace the plunger relative to the injection solution container in the proximal direction from the proximal end position.

[0039] ​ is adapted to prevent it. The plunger positioning mechanism can include, for example, the distal end face of the guiding channel provided on the circumferential surface of the plunger. And, the interaction between the distal end face of the guiding channel and the guiding element received therein can define the proximal end position of the plunger. The injection device can be pre-filled with a compound via a pre-filled syringe (14), vial or other reservoir. In one embodiment, the injection device (regardless of whether it is pre-filled or not) is provided in a sterilized and sealed package. In one embodiment, the injection device is pre-filled with a suitable injection solution and finally sterilized. Such a final sterilization step can include known techniques such as ethylene oxide sterilization or hydrogen peroxide sterilization. Herein, an example of a solution metering and discharging device is disclosed. The example of the solution metering and discharging device has a rotatable plunger and a solution container. The solution container has a first end configured to slidably receive the rotatable plunger and a second end configured to meter and discharge the solution contained in the solution container. The solution metering and discharging device is configured to enable the rotatable plunger to be slidably displaced along a first axis to a first position relative to the solution container while the rotatable plunger is in a first orientation, and to enable the rotatable plunger to be slidably displaced along the first axis from the first position to a second position relative to the solution container while the rotatable plunger is in a second orientation. The second position is closer to the second end of the solution container than the first position, and the rotatable plunger is moved from the first position.

[0040] The injection device can be pre-filled with a compound via a pre-filled syringe (14), vial or other reservoir. In one embodiment, the injection device (regardless of whether it is pre-filled or not) is provided in a sterilized and sealed package. In one embodiment, the injection device is pre-filled with a suitable injection solution and finally sterilized. Such a final sterilization step can include known techniques such as ethylene oxide sterilization or hydrogen peroxide sterilization.

[0041] Herein, an example of a solution metering and discharging device is disclosed. The example of the solution metering and discharging device has a rotatable plunger and a solution container. The solution container has a first end configured to slidably receive the rotatable plunger and a second end configured to meter and discharge the solution contained in the solution container. The solution metering and discharging device is configured to enable the rotatable plunger to be slidably displaced along a first axis to a first position relative to the solution container while the rotatable plunger is in a first orientation, and to enable the rotatable plunger to be slidably displaced along the first axis from the first position to a second position relative to the solution container while the rotatable plunger is in a second orientation. The second position is closer to the second end of the solution container than the first position, and the rotatable plunger is moved from the first position. In one embodiment, the injection device (regardless of whether it is pre-filled or not) is provided in a sterilized and sealed package. In one embodiment, the injection device is pre-filled with a suitable injection solution and finally sterilized. Such a final sterilization step can include known techniques such as ethylene oxide sterilization or hydrogen peroxide sterilization. Herein, an example of a solution metering and discharging device is disclosed. The example of the solution metering and discharging device has a rotatable plunger and a solution container. The solution container has a first end configured to slidably receive the rotatable plunger and a second end configured to meter and discharge the solution contained in the solution container. The solution metering and discharging device is configured to enable the rotatable plunger to be slidably displaced along a first axis to a first position relative to the solution container while the rotatable plunger is in a first orientation, and to enable the rotatable plunger to be slidably displaced along the first axis from the first position to a second position relative to the solution container while the rotatable plunger is in a second orientation. The second position is closer to the second end of the solution container than the first position, and the rotatable plunger is moved from the first position. In one embodiment, the injection device (regardless of whether it is pre-filled or not) is provided in a sterilized and sealed package. In one embodiment, the injection device is pre-filled with a suitable injection solution and finally sterilized. Such a final sterilization step can include known techniques such as ethylene oxide sterilization or hydrogen peroxide sterilization.

[0042] Herein, an example of a solution metering and discharging device is disclosed. The example of the solution metering and discharging device has a rotatable plunger and a solution container. The solution container has a first end configured to slidably receive the rotatable plunger and a second end configured to meter and discharge the solution contained in the solution container. The solution metering and discharging device is configured to enable the rotatable plunger to be slidably displaced along a first axis to a first position relative to the solution container while the rotatable plunger is in a first orientation, and to enable the rotatable plunger to be slidably displaced along the first axis from the first position to a second position relative to the solution container while the rotatable plunger is in a second orientation. The second position is closer to the second end of the solution container than the first position, and the rotatable plunger is moved from the first position. Herein, an example of a solution metering and discharging device is disclosed. The example of the solution metering and discharging device has a rotatable plunger and a solution container. The solution container has a first end configured to slidably receive the rotatable plunger and a second end configured to meter and discharge the solution contained in the solution container. The solution metering and discharging device is configured to enable the rotatable plunger to be slidably displaced along a first axis to a first position relative to the solution container while the rotatable plunger is in a first orientation, and to enable the rotatable plunger to be slidably displaced along the first axis from the first position to a second position relative to the solution container while the rotatable plunger is in a second orientation. The second position is closer to the second end of the solution container than the first position, and the rotatable plunger is moved from the first position. Herein, an example of a solution metering and discharging device is disclosed. The example of the solution metering and discharging device has a rotatable plunger and a solution container. The solution container has a first end configured to slidably receive the rotatable plunger and a second end configured to meter and discharge the solution contained in the solution container. The solution metering and discharging device is configured to enable the rotatable plunger to be slidably displaced along a first axis to a first position relative to the solution container while the rotatable plunger is in a first orientation, and to enable the rotatable plunger to be slidably displaced along the first axis from the first position to a second position relative to the solution container while the rotatable plunger is in a second orientation. The second position is closer to the second end of the solution container than the first position, and the rotatable plunger is moved from the first position. Herein, an example of a solution metering and discharging device is disclosed. The example of the solution metering and discharging device has a rotatable plunger and a solution container. The solution container has a first end configured to slidably receive the rotatable plunger and a second end configured to meter and discharge the solution contained in the solution container. The solution metering and discharging device is configured to enable the rotatable plunger to be slidably displaced along a first axis to a first position relative to the solution container while the rotatable plunger is in a first orientation, and to enable the rotatable plunger to be slidably displaced along the first axis from the first position to a second position relative to the solution container while the rotatable plunger is in a second orientation. The second position is closer to the second end of the solution container than the first position, and the rotatable plunger is moved from the first position. Herein, an example of a solution metering and discharging device is disclosed. The example of the solution metering and discharging device has a rotatable plunger and a solution container. The solution container has a first end configured to slidably receive the rotatable plunger and a second end configured to meter and discharge the solution contained in the solution container. The solution metering and discharging device is configured to enable the rotatable plunger to be slidably displaced along a first axis to a first position relative to the solution container while the rotatable plunger is in a first orientation, and to enable the rotatable plunger to be slidably displaced along the first axis from the first position to a second position relative to the solution container while the rotatable plunger is in a second orientation. The second position is closer to the second end of the solution container than the first position, and the rotatable plunger is moved from the first position. Herein, an example of a solution metering and discharging device is disclosed. The example of the solution metering and discharging device has a rotatable plunger and a solution container. The solution container has a first end configured to slidably receive the rotatable plunger and a second end configured to meter and discharge the solution contained in the solution container. The solution metering and discharging device is configured to enable the rotatable plunger to be slidably displaced along a first axis to a first position relative to the solution container while the rotatable plunger is in a first orientation, and to enable the rotatable plunger to be slidably displaced along the first axis from the first position to a second position relative to the solution container while the rotatable plunger is in a second orientation. The second position is closer to the second end of the solution container than the first position, and the rotatable plunger is moved from the first position. Herein, an example of a solution metering and discharging device is disclosed. The example of the solution metering and discharging device has a rotatable plunger and a solution container. The solution container has a first end configured to slidably receive the rotatable plunger and a second end configured to meter and discharge the solution contained in the solution container. The solution metering and discharging device is configured to enable the rotatable plunger to be slidably displaced along a first axis to a first position relative to the solution container while the rotatable plunger is in a first orientation, and to enable the rotatable plunger to be slidably displaced along the first axis from the first position to a second position relative to the solution container while the rotatable plunger is in a second orientation. The second position is closer to the second end of the solution container than the first position, and the rotatable plunger is moved from the first position. Herein, an example of a solution metering and discharging device is disclosed. The example of the solution metering and discharging device has a rotatable plunger and a solution container. The solution container has a first end configured to slidably receive the rotatable plunger and a second end configured to meter and discharge the solution contained in the solution container. The solution metering and discharging device is configured to enable the rotatable plunger to be slidably displaced along a first axis to a first position relative to the solution container while the rotatable plunger is in a first orientation, and to enable the rotatable plunger to be slidably displaced along the first axis from the first position to a second position relative to the solution container while the rotatable plunger is in a second orientation. The second position is closer to the second end of the solution container than the first position, and the rotatable plunger is moved from the first position. By slidably displacing it to the second position, a certain amount of the solution contained in the solution container is quantitatively discharged. While the rotatable plunger is in the first position and in the first direction configured to prevent the rotatable plunger from slidably displacing to the second position a first stop member, and while the rotatable plunger is in the first position and in the first direction configured to prevent the rotatable plunger from rotating in the first direction about the first axis and a second stop member.

[0043] In this specification, a method example of quantitatively discharging a solution from a solution metering device having a rotatable plunger, a solution container, a first stop member, and a second stop member is disclosed. The method example includes a step of slidably inserting the rotatable plunger into the first end of the solution container, wherein the second end of the solution container is configured to quantitatively discharge the solution contained in the solution container, a step, and while the rotatable plunger is in the first direction, slidably displacing the rotatable plunger along the first axis until it reaches the first position relative to the solution container. The first stop member, while the rotatable plunger is in the first position and in the first direction, prevents the rotatable plunger from slidably displacing to a second position closer to the second end of the solution container than the first position relative to the solution container. The second stop member, while the rotatable plunger is in the first position and in the first direction, prevents the rotatable plunger from rotating in the first direction about the first axis. A step, and rotating the rotatable plunger in the second direction about the first axis until the rotatable plunger is in the first position and in the second direction. A step, and while the rotatable plunger is in the second position, the rotatable plunger relative to the solution container while the plunger is in the first position and in the first direction, the rotatable plunger is centered on the first axis to prevent rotation in the first direction. A step, and rotating the rotatable plunger in the second direction about the first axis until the rotatable plunger is in the second position and in the second direction. A step, and while the rotatable plunger is in the second position, the rotatable plunger relative to the solution container and while the rotatable plunger is in the second position, the rotatable plunger relative to the solution container A step of displaceably sliding a rotatable plunger along a first axis until it reaches a second position, wherein displacing the rotatable plunger slidably from a first position to a second position causes a certain amount of the solution contained in the solution container to be quantitatively discharged.

Brief Description of the Drawings

[0044]

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DETAILED DESCRIPTION OF THE INVENTION

[0045] Figures 1 and 2 show an injection solution transfer system including an injection device 10 and a filling adapter 12 and a stem 100. The filling adapter 12 serves to connect a syringe 14 containing an injection solution to the injection device 10 for filling the injection device 10 with the injection solution from the syringe 14 as shown in FIGS. 33a-33d and as further described hereinafter. The syringe 14 is designed in the form of a prefilled syringe 14 containing an injection solution for use in the eye.

[0046] The filling adapter 12 includes a hollow sleeve 16 shown in more detail in FIGS. 4 and 5. The hollow sleeve 16 is made of a colored plastic material, for example, polycarbonate / acrylonitrile butadiene styrene (PC-ABS), has a lumen provided therein, and the lumen is dimensioned to allow insertion of at least a distal portion of the syringe 14 at one end and insertion of at least a distal portion of the injection device 10 at the opposite end. In an exemplary embodiment of the filling adapter 12 shown in the drawings, the hollow sleeve 16 has a substantially circular hollow cylindrical shape, and the lumen extending therethrough has a substantially circular cross-sectional shape.

[0047] The filling adapter 12 further includes an adapter element 18, which is received within the hollow sleeve 16 and includes a first connection port 20 and a second connection port 22. The adapter element 18 can be made of, for example, polycarbonate and is shown in more detail in FIGS. 6-10. In particular, as shown in FIG. 8, the adapter element 18 is provided with two retaining shoulders 23 protruding from the outer peripheral surface of the adapter element 18 in opposite directions from each other. Each retaining shoulder 23 In order to fix the adapter element 18 in place within the hollow sleeve 16, the hollow sleeve 16 interacts with a pair of complementary crush ribs 24 that project from the inner peripheral surface thereof. The retaining shoulder 23 and the complementary crush ribs 24 form an interference fit to securely fix the adapter element 18 in place within the hollow sleeve 16.

[0048] When the filling adapter 12 is connected to the syringe 14 as shown in FIGS. 33a - 33c, the first connection port 20 of the adapter element 18 is adapted to be connected to the syringe 14, i.e., the distal end of the syringe 14. As is particularly apparent from FIG. 10, the first connection port 20 of the adapter element 18 forms a female luer taper that is adapted to interact with a male luer taper provided at the distal end of the syringe 14 to establish a fluid - tight connection between the syringe 14 and the adapter element 18. The second connection port 22 of the adapter element 18 is adapted to be connected to the injection device 10.

[0049] The adapter element 18 is provided with a through - opening 26 that extends through the adapter element 18 in a direction substantially parallel to the longitudinal axis L1 of the filling adapter 12 (see particularly FIG. 1 0). The cannula 27 projects from the second connection port 22 of the adapter element 18 and is disposed in fluid communication with the through - opening 26 that extends through the adapter element 18 (see particularly FIGS. 9 and 10). The cannula 27 is made of stainless steel. However, the hollow sleeve 16 of the filling adapter 12 extends beyond the distal tip of the cannula 27. As a result, the user is protected from the cannula 27 during handling of the filling adapter 12.

[0050] The adapter element 18 serves to establish a fluid connection between the syringe 14 and the injection device 10, that is, as shown in Fig. 33a, when the syringe 14 is connected to the first connection port 20 of the adapter element 18 and the injection device 10 is connected to the second connection port 22 of the adapter element 18, the injection solution contained in the syringe 14 can be transferred from the distal end of the syringe 14 into the injection solution container 30 of the injection device 10 through the through opening 26 provided in the adapter element 18 and further through the cannula 27, as shown in Figs. 33b and 33c, by manually pressing the plunger 28 of the syringe 14. In particular, as is apparent from Figs. 4 and 5, the hollow sleeve 16 of the filling adapter 12 is provided with at least one elastic clip 32 (see Figs. 33a and 33b) adapted to engage with the collar 34 of the syringe 14 when the syringe 14 engages with the first connection port 20 of the adapter element 18 in the region of the first end facing the syringe 14 when the syringe 14 engages with the first connection port 20 of the adapter element 18. In the embodiment of the hollow sleeve 16 shown in the drawings, two elastic clips 32 are provided on the hollow sleeve 16. Each elastic clip 32 comprises an arm 36 which extends in a recess 38 provided in the hollow sleeve 16 substantially parallel to the longitudinal axis L1 of the filling adapter 12 in the direction of the first end of the hollow sleeve 16. A latch nose 40 projects from the inner surface of the arm 36 in the region of the free end of the arm 36.

[0051]

[0052] ​​​​​​​​​​​​​​​When the syringe 14 engages with the first connection port 20, due to the interaction with the color 34 of the syringe 14, the elastic clip 32 is bent outward. However, as soon as the syringe 14 reaches its final position with respect to the adapter element 18, that is, when the distal tip of the syringe 14 is connected to the first connection port 20 of the adapter element 18 and the syringe 14 assumes the position shown in FIG. 33b with respect to the hollow sleeve 16, the elastic clip 32 resumes its original position substantially parallel to the longitudinal axis L1 of the filling adapter 12, causing the latch nose 40 to engage with the end face of the color 34 of the syringe 14. As a result, the syringe 14 is firmly connected to the hollow sleeve 16. On the outer peripheral surface of the hollow sleeve 16, in the region of its first end, two first gripping structures 42 are provided, and each gripping structure 42 is designed in the form of a knob arrangement. The first gripping structure simplifies the handling of the filling adapter 12 while the syringe 14 is being connected to the filling adapter 12. Further, the hollow sleeve 16 has an outer diameter larger than the outer diameter of the hollow sleeve 16 in the intermediate section disposed between the first end and the second end in the region of its first end and in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. Such a design of the hollow sleeve 16 further simplifies the gripping and thus the handling of the filling adapter 12. As shown in FIG. 11, the injection solution container 30 of the injection device 10 is designed in the form of an inner injection solution container 30 housed in a protective outer barrel 44. When the syringe 14 reaches its final position with respect to the adapter element 18, that is, when the distal tip of the syringe 14 is connected to the first connection port 20 of the adapter element 18 and the syringe 14 assumes the position shown in FIG. 33b with respect to the hollow sleeve 16, the elastic clip 32 resumes its original position substantially parallel to the longitudinal axis L1 of the filling adapter 12, causing the latch nose 40 to engage with the end face of the color 34 of the syringe 14. As a result, the syringe 14 is firmly connected to the hollow sleeve 16. On the outer peripheral surface of the hollow sleeve 16, in the region of its first end, two first gripping structures 42 are provided, and each gripping structure 42 is designed in the form of a knob arrangement. The first gripping structure simplifies the handling of the filling adapter 12 while the syringe 14 is being connected to the filling adapter 12. Further, the hollow sleeve 16 has an outer diameter larger than the outer diameter of the hollow sleeve 16 in the intermediate section disposed between the first end and the second end in the region of its first end and in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. Such a design of the hollow sleeve 16 further simplifies the gripping and thus the handling of the filling adapter 12. When the syringe 14 reaches its final position with respect to the adapter element 18, that is, when the distal tip of the syringe 14 is connected to the first connection port 20 of the adapter element 18 and the syringe 14 assumes the position shown in FIG. 33b with respect to the hollow sleeve 16, the elastic clip 32 resumes its original position substantially parallel to the longitudinal axis L1 of the filling adapter 12, causing the latch nose 40 to engage with the end face of the color 34 of the syringe 14. As a result, the syringe 14 is firmly connected to the hollow sleeve 16. On the outer peripheral surface of the hollow sleeve 16, in the region of its first end, two first gripping structures 42 are provided, and each gripping structure 42 is designed in the form of a knob arrangement. The first gripping structure simplifies the handling of the filling adapter 12 while the syringe 14 is being connected to the filling adapter 12. Further, the hollow sleeve 16 has an outer diameter larger than the outer diameter of the hollow sleeve 16 in the intermediate section disposed between the first end and the second end in the region of its first end and in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. Such a design of the hollow sleeve 16 further simplifies the gripping and thus the handling of the filling adapter 12. When the syringe 14 reaches its final position with respect to the adapter element 18, that is, when the distal tip of the syringe 14 is connected to the first connection port 20 of the adapter element 18 and the syringe 14 assumes the position shown in FIG. 33b with respect to the hollow sleeve 16, the elastic clip 32 resumes its original position substantially parallel to the longitudinal axis L1 of the filling adapter 12, causing the latch nose 40 to engage with the end face of the color 34 of the syringe 14. As a result, the syringe 14 is firmly connected to the hollow sleeve 16.

[0053] On the outer peripheral surface of the hollow sleeve 16, in the region of its first end, two first gripping structures 42 are provided, and each gripping structure 42 is designed in the form of a knob arrangement. The first gripping structure simplifies the handling of the filling adapter 12 while the syringe 14 is being connected to the filling adapter 12. Further, the hollow sleeve 16 has an outer diameter larger than the outer diameter of the hollow sleeve 16 in the intermediate section disposed between the first end and the second end in the region of its first end and in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. Such a design of the hollow sleeve 16 further simplifies the gripping and thus the handling of the filling adapter 12. On the outer peripheral surface of the hollow sleeve 16, in the region of its first end, two first gripping structures 42 are provided, and each gripping structure 42 is designed in the form of a knob arrangement. The first gripping structure simplifies the handling of the filling adapter 12 while the syringe 14 is being connected to the filling adapter 12. Further, the hollow sleeve 16 has an outer diameter larger than the outer diameter of the hollow sleeve 16 in the intermediate section disposed between the first end and the second end in the region of its first end and in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. Such a design of the hollow sleeve 16 further simplifies the gripping and thus the handling of the filling adapter 12. On the outer peripheral surface of the hollow sleeve 16, in the region of its first end, two first gripping structures 42 are provided, and each gripping structure 42 is designed in the form of a knob arrangement. The first gripping structure simplifies the handling of the filling adapter 12 while the syringe 14 is being connected to the filling adapter 12. Further, the hollow sleeve 16 has an outer diameter larger than the outer diameter of the hollow sleeve 16 in the intermediate section disposed between the first end and the second end in the region of its first end and in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. Such a design of the hollow sleeve 16 further simplifies the gripping and thus the handling of the filling adapter 12. On the outer peripheral surface of the hollow sleeve 16, in the region of its first end, two first gripping structures 42 are provided, and each gripping structure 42 is designed in the form of a knob arrangement. The first gripping structure simplifies the handling of the filling adapter 12 while the syringe 14 is being connected to the filling adapter 12. Further, the hollow sleeve 16 has an outer diameter larger than the outer diameter of the hollow sleeve 16 in the intermediate section disposed between the first end and the second end in the region of its first end and in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. Such a design of the hollow sleeve 16 further simplifies the gripping and thus the handling of the filling adapter 12. On the outer peripheral surface of the hollow sleeve 16, in the region of its first end, two first gripping structures 42 are provided, and each gripping structure 42 is designed in the form of a knob arrangement. The first gripping structure simplifies the handling of the filling adapter 12 while the syringe 14 is being connected to the filling adapter 12. Further, the hollow sleeve 16 has an outer diameter larger than the outer diameter of the hollow sleeve 16 in the intermediate section disposed between the first end and the second end in the region of its first end and in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. Such a design of the hollow sleeve 16 further simplifies the gripping and thus the handling of the filling adapter 12. On the outer peripheral surface of the hollow sleeve 16, in the region of its first end, two first gripping structures 42 are provided, and each gripping structure 42 is designed in the form of a knob arrangement. The first gripping structure simplifies the handling of the filling adapter 12 while the syringe 14 is being connected to the filling adapter 12. Further, the hollow sleeve 16 has an outer diameter larger than the outer diameter of the hollow sleeve 16 in the intermediate section disposed between the first end and the second end in the region of its first end and in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. Such a design of the hollow sleeve 16 further simplifies the gripping and thus the handling of the filling adapter 12. On the outer peripheral surface of the hollow sleeve 16, in the region of its first end, two first gripping structures 42 are provided, and each gripping structure 42 is designed in the form of a knob arrangement. The first gripping structure simplifies the handling of the filling adapter 12 while the syringe 14 is being connected to the filling adapter 12. Further, the hollow sleeve 16 has an outer diameter larger than the outer diameter of the hollow sleeve 16 in the intermediate section disposed between the first end and the second end in the region of its first end and in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. Such a design of the hollow sleeve 16 further simplifies the gripping and thus the handling of the filling adapter 12. On the outer peripheral surface of the hollow sleeve 16, in the region of its first end, two first gripping structures 42 are provided, and each gripping structure 42 is designed in the form of a knob arrangement. The first gripping structure simplifies the handling of the filling adapter 12 while the syringe 14 is being connected to the filling adapter 12. Further, the hollow sleeve 16 has an outer diameter larger than the outer diameter of the hollow sleeve 16 in the intermediate section disposed between the first end and the second end in the region of its first end and in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. Such a design of the hollow sleeve 16 further simplifies the gripping and thus the handling of the filling adapter 12.

[0054] As shown in FIG. 11, the injection solution container 30 of the injection device 10 is designed in the form of an inner injection solution container 30 housed in a protective outer barrel 44. On the outer peripheral surface of the hollow sleeve 16, in the region of its first end, two first gripping structures 42 are provided, and each gripping structure 42 is designed in the form of a knob arrangement. The first gripping structure simplifies the handling of the filling adapter 12 while the syringe 14 is being connected to the filling adapter 12. Further, the hollow sleeve 16 has an outer diameter larger than the outer diameter of the hollow sleeve 16 in the intermediate section disposed between the first end and the second end in the region of its first end and in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. Such a design of the hollow sleeve 16 further simplifies the gripping and thus the handling of the filling adapter 12. The protective outer barrel 44 is integrally formed with each other and is made of a sterilized plastic material. The protective outer barrel 44 is provided with a flange element 46 in the region of its proximal end. A male Luer taper 48 is provided at the distal end of the injection solution container 30. The male Luer taper 48 interacts with a female Luer taper 50 provided at the second connection port 22 of the adapter element 18 of the filling adapter 12 when the filling adapter 12 is connected to the injection device 10 as shown in FIGS. 2 and 3. The male and female Luer tapers 48 and 50 can establish a fluid-tight connection between the distal end of the injection solution container 30 and the adapter element 18 of the filling adapter 12. As can be further seen from FIG. 11, the outer barrel 44 of the injection device 10 is provided with a Luer thread 52 in the region of its distal end. When the filling adapter 12 is connected to the injection device 10 as shown in FIGS. 2 and 3, the Luer thread 52 interacts with a complementary Luer thread 54 provided on the outer periphery of the second connection port 22 of the adapter element 18 (see FIGS. 6 and 8-10). As a result, a secure connection between the outer barrel 44 of the injection device 10 and the adapter element 18 of the filling adapter 12 can also be achieved.

[0055] To simplify the handling of the filling adapter 12 when engaging the injection device 10 with the second connection port 22 of the adapter element 18, the hollow sleeve 16 is provided with a second gripping structure 56 on its outer peripheral surface in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. The second gripping structure 56 As shown in FIGS. 2 and 3, when the filling adapter 12 is connected to the injection device 10, the Luer thread 52 interacts with a complementary Luer thread 54 provided on the outer periphery of the second connection port 22 of the adapter element 18 (see FIGS. 6, 8-10). As a result, a reliable connection between the outer barrel 44 of the injection device 10 and the adapter element 18 of the filling adapter 12 can also be achieved. (See FIGS. 6, 8-10). To simplify the handling of the filling adapter 12 when engaging the injection device 10 with the second connection port 22 of the adapter element 18, the hollow sleeve 16 is provided with a second gripping structure 56 on its outer peripheral surface in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18.

[0056] When engaging the injection device 10 with the second connection port 22 of the adapter element 18, to simplify the handling of the filling adapter 12, the hollow sleeve 16 is provided with a second gripping structure 56 on its outer peripheral surface in the region of its second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. The second gripping structure 56 is provided on the outer peripheral surface in the region of the second end facing the injection device 10 when the injection device 10 engages with the second connection port 22 of the adapter element 18. The second gripping structure 56 is designed in the form of two gripping rib arrays, with each individual gripping rib extending substantially parallel to the longitudinal axis L1 of the filling adapter 12.

[0057] Furthermore, as shown in FIG. 15, the hollow sleeve 16 is provided with longitudinal guide ribs 58 that project from the inner peripheral surface of the hollow sleeve 16 and extend substantially parallel to the longitudinal axis L1 of the filling adapter 12. The guide ribs 58 serve to guide the injection device 10 so as to engage with the second connection port 22. The guiding function of the guide ribs 58 prevents the cannula 27 from contacting the injection solution container 30 of the injection device 10 when connecting the filling adapter 12 to the injection device 10. The hollow sleeve 16 and the longitudinal guide ribs 58 are designed such that a sliding fit occurs between the guide ribs 58 and the outer surface of the outer barrel 54 of the injection device 10, i.e., they have such a shape and dimensions.

[0058] Returning to FIGS. 9 and 10, the through-opening 26 that extends through the adapter element 18 includes an inlet section 26a disposed adjacent to the first connection port 20. When the filling adapter 12 is in use, the injection solution discharged from the syringe 14 flows into the through-opening 26 through its inlet section 26a, and the inlet section 26a has a reduced flow cross-sectional area in the direction of the flow of the injection solution discharged from the syringe 14. Further, the through-opening 26 includes an intermediate section 26b, and the intermediate section 26b is disposed downstream of the inlet section 26a in the direction of the flow of the injection solution discharged from the syringe 14 during use of the filling adapter 12. The intermediate section 26b of the through-opening 26 is adjacent to the intermediate section 26b. ​​​​​​​​​​​​​​​A substantially constant flow that substantially corresponds to the minimum flow cross-sectional area of the inlet section 26a in contact has a cross-sectional area. Finally, the through-opening 26 includes a receiving section 26c, and the receiving section 26c is downstream of the intermediate section 26b, i.e., adjacent to the second connection port 22, in the direction of the flow of the injection solution discharged from the syringe 14 during use of the filling adapter 12. The receiving section 26c is arranged adjacent to the second connection port 22. The receiving section 26c has a flow cross-sectional area larger than that of the intermediate section 26b. As can be further seen from FIGS. 9 and 10, the cannula 27 extends into at least a part of the intermediate section 26b of the through-opening 26, whereby the intermediate section 26b or a part thereof of the through-opening 26 forms a cannula receiving bore of the adapter element 18 to which the proximal end of the cannula 27 is fixed. The cannula 27 is received in the cannula receiving bore by an interference fit. In addition, the cannula 27 is provided with an inclined end.

[0059] This design of the cannula 27 and the cannula receiving bore minimizes the generation of wear particles when the cannula 27 is attached to the cannula receiving bore. The final connection between the adapter element 18 and the cannula 27 is made by a UV-curing adhesive. The cannula 27 extends from the intermediate section 26b of the through-opening 26, through the receiving section 26c of the through-opening 26 and the second connection port 22, and projects from the second connection port 22. The receiving section 26c of the through-opening 26, the second connection port 22, and the hollow sleeve 16 of the filling adapter 12 define a concentric arrangement around the cannula 27 (see FIG. 3 in particular). The cannula 27 extends so as to project from the second connection port 22. The receiving section 26c of the through-opening 26, the second connection port 22, and the hollow sleeve 16 of the filling adapter 12 define a concentric arrangement around the cannula 27. This design of the cannula 27 and the cannula receiving bore minimizes the generation of wear particles when the cannula 27 is attached to the cannula receiving bore. The final connection between the adapter element 18 and the cannula 27 is made by a UV-curing adhesive. The cannula 27 extends from the intermediate section 26b of the through-opening 26, through the receiving section 26c of the through-opening 26 and the second connection port 22, and projects from the second connection port 22. The receiving section 26c of the through-opening 26, the second connection port 22, and the hollow sleeve 16 of the filling adapter 12 define a concentric arrangement around the cannula 27. The receiving section 26c of the through-opening 26, the second connection port 22, and the hollow sleeve 16 of the filling adapter 12 define a concentric arrangement around the cannula 27. The receiving section 26c of the through-opening 26, the second connection port 22, and the hollow sleeve 16 of the filling adapter 12 define a concentric arrangement around the cannula 27. The receiving section 26c of the through-opening 26, the second connection port 22, and the hollow sleeve 16 of the filling adapter 12 define a concentric arrangement around the cannula 27. (See FIG. 3 in particular).

[0060] In particular, as shown in FIG. 8, the adapter element 18 is provided with two retaining shoulders 60 , and these retaining shoulders 60 project from the outer peripheral surface of the adapter element 18 in opposite directions in the region of the inlet section 26a and the intermediate section 26b of the through-opening 26 that extends through the adapter element 18.

[0061] When the filling adapter 12 is connected to the injection device 10, the cannula 27 extends into the injection solution container 30 of the injection device 10, that is, the distal tip of the cannula 27 is disposed at a distance from the distal end of the injection solution container 30 inside the injection solution container 30 (see FIG. 3 in particular). As a result, when transferring the injection solution from the syringe 14 to the injection device 10, the injection solution exiting from the syringe 14 via the cannula 27 is supplied to the injection solution container 30 of the injection device 10 at a position inside the injection solution container 30 that is at a distance from the distal end of the injection solution container 30, rather than in the region of the distal end of the injection solution container 30.

[0062] As shown in FIGS. 33a to 33c, the longitudinal axis L1 of the filling adapter 12 and the longitudinal axis L2 of the injection device 10 are substantially perpendicular, and with the distal end of the injection device 10 facing downward, simply holding the filling adapter 12 and the injection device 10 in the upright position can cause a downward flow of the injection solution in the direction of the distal end of the injection solution container 30 and further in the direction of the adapter element 18, based on the gravity of the injection solution. The portion of the injection solution that is discharged from the distal tip of the cannula 27 and flows back in the direction of the adapter element 18 in a manner driven by gravity It is received in the receiving section 26c of the opening 26 provided in the adapter element 18. Injection is trapped in the solution, and thus the air bubbles to be transferred from the syringe 14 to the injection solution container 3 0 together with the liquid phase of the injection solution are carried along with this gravity-driven flow, and due to the higher density ratio of the liquid phase of the injection solution, they are pushed in the direction of the distal end of the injection solution container 30 and further in the direction of the adapter element 18.

[0063] Finally, the adapter element 18 is provided with a venting device 64, and the venting device 6 4 is adapted to exhaust the gas introduced from the syringe 14 into the injection device 10, i.e., into the injection solution container 3 0, into the surrounding environment through the through-opening 26 and the cannula 27. Thus, by means of the venting device, the above-described gravity -driven flow of the injection solution can discharge the trapped air bubbles, especially air bubbles, which are conveyed back from the distal tip of the cannula 27 to the adapter element 18, into the surrounding environment . Thus, the filling adapter 12 enables bubble-free filling of the injection solution into the injection device 10. As a result, before connecting the syringe 14 to the filling adapter 12 , it is possible to dispense with manually discharging the trapped gas from the syringe 14. Furthermore, it becomes possible to accurately and reliably prepare the desired dose of the injection solution in the injection device 10 . .

[0064] The venting device 64 comprises two radial bores 66 that connect the through-opening 26 extending through the adapter element 18 to the surrounding environment . In particular, the radial bores 66 connect the receiving section 26c of the through-opening 2 6 to the outer peripheral surface of the adapter element 18 and thus to the surrounding environment is present. In the illustrated embodiment of the filling adapter 18, the radial bore 66 of the venting device 64 of the adapter element 18 extends coaxially from the outer peripheral surface of the adapter element 18 to the receiving section 26c of the through opening 26 so as to connect the receiving section 26c of the through opening 26 to the ambient environment. To ensure that air bubbles trapped in the injection solution can be vented to the ambient environment as required without discharging a substantial amount of the liquid phase of the injection solution to the ambient environment, the flow cross-sectional area, i.e., the diameter, of the radial bore 66 is selected according to the physical properties of the injection solution transferred from the syringe 14 to the injection device 10, in particular the density ratio, viscosity and surface tension. To ensure proper functioning of the venting device 64, the retaining shoulder 23 projects from the outer peripheral surface of the adapter element 18 in the regions of the inlet section 26a and the intermediate section 26b of the through opening 26 that extend through the adapter element 18. Such a configuration ensures that there is a gap 68 between the outer peripheral surface of the adapter element 18 and the inner peripheral surface of the hollow sleeve 16 in the region of the receiving section 26c of the through opening 26, thereby enabling unobstructed discharge of gas from the receiving section 26c via the radial bore 66 of the venting device 64. The injection device 10 of the injection solution transfer system 100 further comprises a plunger 70 shown in more detail in FIG. 12. In the illustrated embodiment of the injection device 10, the plunger 70

[0065] is made of polycarbonate. At least a part of the plunger 70 is slidably received within the injection solution container 30 of the injection device 10. The plunger 70 is injected extends through the adapter element 18 in the regions of the inlet section 26a and the intermediate section 26b of the through opening 26 that extend through the adapter element 18, projecting from the outer peripheral surface of the adapter element 18. With such a configuration, a gap 68 is ensured to exist between the outer peripheral surface of the adapter element 18 and the inner peripheral surface of the hollow sleeve 16 in the region of the receiving section 26c of the through opening 26, thereby enabling unobstructed discharge of gas from the receiving section 26c via the radial bore 66 of the venting device 64. is present between the outer peripheral surface of the adapter element 18 and the inner peripheral surface of the hollow sleeve 16 in the region of the receiving section 26c of the through opening 26, thereby ensuring that the gas from the receiving section 26c through the radial bore 66 of the venting device 64 is not obstructed and can be discharged.

[0066] The injection device 10 of the injection solution transfer system 100 further comprises a plunger 70 shown in more detail in FIG. 12. In the illustrated embodiment of the injection device 10, the plunger 70 is made of polycarbonate. At least a part of the plunger 70 is slidably received within the injection solution container 30 of the injection device 10. The plunger 70 is injected is slidably received within the injection solution container 30 of the injection device 10. The plunger 70 is To discharge the injection solution contained in the injection solution container 30 of the device 10 from the injection solution container 30 it is displaceable distally relative to the injection solution container 30 along the longitudinal axis of the plunger 70. At the proximal end protruding proximally from the injection solution container 30, the plunger 70 supports an activation button 72, and the activation button 72 is used to displace the plunger 70 distally relative to the injection solution container 30 along the longitudinal axis of the plunger 70 and can be depressed by the user.

[0067] At its distal end, the plunger 70 is provided with a tip element 74 attached to a plunger rod 76 (see FIG. 13). The connection between the plunger rod 76 and the tip element 7 4 is effected by the interaction of a tip catch 78 provided at the distal end of the plunger rod 76 with a catch receiving portion 80 of the tip element 74. Further, the tip element 74 is provided with a sealing element 82, and the sealing element 82 is provided in a region of the outer peripheral surface of the tip element 74 and interacts to seal with the inner peripheral surface of the injection solution container 30.

[0068] The plunger 70 of the injection device 10 can be arranged in a filling position as shown in FIGS. 33a to 33d. When the plunger 70 is arranged in its filling position and the injection device 10 engages with the second connection port 22 of the adapter element 18 of the filling adapter 12, the distal tip of the plunger 70, i.e., the distal end face of the tip element 74 provided at the distal tip of the plunger 70, is arranged at a desired close distance D from the distal tip of the cannula 27 of the filling adapter 12 (see FIG. 14). For example, the injection device 10 and the filling adapter 12 are such that the distal tip of the plunger 70, i.e., the distal end face of the tip element 74 provided at the distal tip of the plunger 70, is arranged at a desired close distance D from the distal tip of the cannula 27 of the filling adapter 12 (see FIG. 14). For example, the injection device 10 and the filling adapter 12 are such that the distal tip of the plunger 70 is The distance D between the tip and the distal tip of the cannula 27 can be designed to be set to approximately 1.5 mm ± 0.5 mm. The distal tip of the plunger 70 and the distal tip of the cannula 27 are arranged at a close distance. By doing so, the injection solution supplied to the injection solution container 30 through the cannula 27 is surely caused to flow in the direction of the venting device 64. As a result, it is possible to surely ensure airless filling of the injection solution into the injection solution container 30.

[0069] Finally, the hollow sleeve 16 is provided with two observation windows 83 for observing the filling of the injection solution from the syringe 14 into the injection device 10. Through the observation windows 83, it is possible to view the inside of the injection device 10 and the distal tip of the cannula 27 without being obstructed.

[0070] The plunger 70 is displaceably received in the housing 84 of the injection device 10, and the housing 84 comprises a first housing element 86 shown in more detail in FIGS. 16 to 19 and a second housing element 88 shown in more detail in FIGS. 20 to 23. Both the first and second housing elements 86, 88 are made of polycarbonate / acrylic nitrile butadiene styrene and have different colors. The first housing element 86 is provided with a plunger through-hole 90, and the plunger through-hole 90 is configured to receive the plunger rod 76 so that the plunger 70 can be displaced relative to the first housing element 86 in a direction along its longitudinal axis. The guiding element 92 is provided on the first housing element 86 so as to project into the plunger through-hole 90. When the plunger 70, i.e., the plunger rod 76, is received in the plunger through-hole 90 of the first housing element 86, each guiding element 92 guides The guide channel 94 engages the plunger 70, i.e., the plunger rod. The plunger 70 is provided on the periphery of the head 76 and extends along the longitudinal axis of the plunger 70 ( See especially Figures 19a and 19b).

[0071] To assemble the plunger 70 to the first housing element 86, the plunger rod 76 An assembly channel 96 is provided on the outer peripheral surface of the guide channel 96. 94 and extends circumferentially through the plunger rod 76 into the guide channel 94. The plunger 70 is assembled to the first housing element 86. During insertion, the guide element 92 engages with the assembly channel 96. The plunger 70 then 19a and 19b, until the guide element 92 is received in the guide channel 94 in a guided manner (see FIG. 19a and FIG. 19b). See Figure 19b).

[0072] To simplify the handling of the injection solution transfer system 100, the injection device 10 is With the plunger 70 disposed in its filling position corresponding to the position of the proximal end of the plunger 70, The plunger positioning mechanism 98 positions the plunger 70 at its proximal end position. 30 in a proximal direction relative to the injection solution container 30 from its filling position. However, the plunger positioning mechanism 98 prevents the plunger 7 from 0 from its filling position in a distal direction relative to the injection solution container 30. Specifically, the plunger positioning mechanism 98 is provided on the circumferential surface of the plunger rod 78. The distal end surface 102 of the guide channel 94 and the guide element provided in the first housing element 86. 92. The plunger 70 is positioned at its proximal end corresponding to its fill position. When disposed at the portion position, the guiding element 92 abuts against the distal end face 102 of the guiding channel 94. . Therefore, due to the interaction between the distal end face 102 of the guiding channel 94 and the guiding element 92, the plunger 70 is prevented from moving further in the proximal direction, and thus the proximal end position of the plunger 70, that is, the filling position, is defined.

[0073] The second housing element 88 includes two identical parts (see FIGS. 20 and 21), and each part is provided with an interference fit pin 104 and an interference fit receiving portion 106. The two housing parts of the second housing element 88 are assembled by engaging the interference fit pin 104 with the respective interference fit receiving portions 106 as shown in FIG. 22. Alignment pins 108 are provided to align the parts of the second housing element 88 with each other during assembly, and the alignment pins 108 are received in the respective alignment receiving portions 110 when connecting the parts of the second housing element 88. The injection solution container 30 and the protective outer barrel 44 are continued to the second housing element 88 via a flange element 46 extending from the proximal end of the outer barrel 44. Specifically, the flange element 46 is received in a receiving portion 112 having an appropriate shape and dimensions of the second housing element 88 (see FIG. 23).

[0074] Particularly as shown in FIG. 26, a plunger guide 114 is provided on the second housing element 88, and the plunger guide 114 restrains the plunger rod 76 so as to prevent the plunger 70 from rotating with respect to the second housing element 88. The first drag mechanism 1 16 applies a holding force to hold the plunger 70 in the current position with respect to the second housing element 88. ​​​​​​​​​is adapted to be as follows. Therefore, the first drag mechanism 116 prevents the plunger 70 from being inadvertently displaced relative to the injection solution container 3 0, so that an active manual actuation of the plunger 70 is required, for example, by applying a pressing force to the actuation button 72, in order to displace the plunger 70 relative to the injection solution container 30 0. The first drag mechanism 116 includes an elastic drag element 118 provided on the second housing element 88. The elastic drag element 118 elastically holds the plunger 70, that is, the elastic drag element 11 8 is elastically pushed from the rest position to the biasing position by interaction with the plunger 70, and due to its elasticity, an elastic reaction force is applied to the plunger 70, and by this reaction force, the plunger 70 is held in the current position. Specifically, the elastic drag element 118 interacts with the drag rib 1 20, and the drag rib 120 is provided on the outer peripheral surface of the plunger rod 76 and extends substantially parallel to the longitudinal axis of the plunger 70 0.

[0075] The injection device 10 further includes a plunger lock mechanism 122. The plunger lock mechanism 122 interacts with the filling adapter 12, that is, the hollow sleeve 16 of the filling adapter 12, so that when the injection device 10 is connected to the filling adapter 12, the plunger 70 of the injection device 10 is prevented from moving relative to the injection solution container 30 in the distal direction from its filling position, that is, in the direction of the distal tip of the cannula 27 0. The plunger lock mechanism 122 serves to prevent inadvertent contact between the distal tip of the plunger 70, that is, the plunger 70, and the distal tip of the cannula 27. Here, the plunger lock mechanism 122 The function of mechanism 122 will now be explained in more detail with reference to Figures 27 to 32.

[0076] Specifically, the plunger lock mechanism 122 includes a lever element 124 (see FIGS. 27 and 28). 28), the lever element 124 is mounted in the second housing element 88 as shown in FIGS. The lever can be displaced between an active position shown in FIG. When the element 124 is placed in its active position, the injection device 10 is As plunger 70 moves distally from its loading position when connected to actuator 12, 2 and 3. The plunger 70 and hollow sleeve 16 of the filling adapter 12 interact to prevent Conversely, when the lever element 124 is disposed in its inactive position, the injection When the device 10 is not connected to the fill adapter 12, the plunger 70 The lever element 124 is configured to move distally from its active position. and its inactive position. Specifically, the lever element 124 is provided with a hinge 126. The hinge 126 connects the lever element 124 to the pivot shaft 12 provided in the second housing element 88. 8 and rotatably attached.

[0077] The lever element 124 further includes a pair of foot elements 130. extend substantially parallel to one another and move the lever element 124 in its active position. To maintain the filling adapter in place, when the injection device 10 is connected to the filling adapter 12, In particular, as shown in FIG. 29, the foot element 130 is in contact with the fill adapter 12. When facing 2 and the injection device 10 is connected to the filling adapter 12, the injection device 1 contacts the locking rim 132 of the hollow sleeve 16 facing 0. Due to the interaction between the locking rim 132 of the hollow sleeve 16 and the foot element 130, the lever element 124 is pushed proximally substantially parallel to the longitudinal axis of the plunger 70 and comes into contact with the plunger 70, and thus is held in its active position shown in FIGS. 29 and 31.

[0078] The lever element 124 is provided with a stop device 134 having two tabs extending from the proximal end face of the lever element 124. Furthermore, the proximal portion of the plunger 70 extends further in a direction substantially perpendicular to the longitudinal axis of the plunger 70 than the distal portion of the plunger 70. As a result, a shoulder defining a contact surface 1 36 is formed in the transition region between the distal portion and the proximal portion of the plunger 70. Specifically, the contact surface 136 is defined by the outer portion of the distal end face of the proximal plunger portion protruding from the outer peripheral surface of the distal plunger portion. When the lever element 124 is disposed in its active position shown in FIG. 29, the two tabs of the stop device 134 contact the contact surface 136 of the plunger 70. As a result, the lever element 124 is held in its active position, and at the same time, the plunger 70 is prevented from moving distally from its filling position.

[0079] The plunger locking mechanism 122 also includes a holding device 138, and the holding device 138 is such that when the lever element 124 is maintained in its active position by the interaction between the locking rim 132 and the foot element 130, the foot element 130 is the locking rim of the filling adapter 12. When the lever element 124 is maintained in its active position by the interaction between the locking rim 132 and the foot element 130, the foot element 130 is the locking rim of the filling adapter 12. When the lever element 124 is maintained in its active position by the interaction between the locking rim 132 and the foot element 130, the foot element 130 is the locking rim of the filling adapter 12. 132 of the lever element 124. In particular, the holding device 138 is adapted to hold the lever element 124 When the foot element 130 is pushed into engagement with the plunger 70, the foot element 130 extends through the hollow sleeve 16. 132, thereby preventing it from disengaging from the fill adapter 12. The retaining device is provided in the second housing element 88 and is designed in the form of a retaining rib. The retaining rib prevents the foot element 130 of the lever element 124 from being pulled forward by the plunger 70. The deformation away from the plunger 70 in a direction substantially perpendicular to the longitudinal axis It is prevented.

[0080] As discussed above and as shown in Figures 33a-33c, plunger 70 is disposed in the fill position. In the state where the injection device 10 is placed in the injection position, the injection solution is dispensed from the syringe 14 into the injection solution container 30 of the injection device 10. After the transfer is completed, the female luer provided on the second connection port 22 of the adapter element 18 is The taper 50 engages the male luer taper 48 provided at the distal end of the injection solution container 30. By releasing the luer thread 54 on the second connection port 22, the luer thread 54 is released from the luer thread 54 on the second connection port 22. 2, by disengaging the luer threads 52 on the distal end of the outer barrel 44. The filling adapter 12 and the syringe 14 are then removed from the injection device 10 (see FIG. 33d). (see).

[0081] As soon as the filling adapter 12 is removed from the injection device 10, That is, the locking rim 132 of the hollow sleeve 16 is engaged with the foot element 130 of the lever element 124. Therefore, the plug moves distally within the injection solution container 30 of the injection device 10. To displace the plunger 70, when a pressing force is applied to the plunger 70, the lever element 1 24 is displaced to the non - active position shown in FIG. 30. In particular, the lever element 124 rotates from its active position to its non - active position about its pivot axis 128, whereby it no longer obstructs the plunger 70. As a result, the displacement of the plunger 70 is no longer hindered. As a result, for example, a needle (not shown in the drawings) can be attached to the injection device 10 using the luer thread 52 provided at the distal end of the outer barrel 44, and the injection device 10 can be operated as will be described later. To administer an accurate dose of the injection solution contained in the injection solution container 30, particularly an accurate micro - dose of, for example, 10 μl to a patient, in a first step, as shown in FIG. 34a, the plunger 70 is displaced distally with respect to the injection solution container 30 so that excess injection solution must be discharged from the injection solution container 30. Thereafter, the desired dose of the injection solution can be injected into the patient.

[0082]

[0083] Thus, the injection device 10 is provided with a first plunger stop mechanism 140 (see FIG. 34) adapted to stop the plunger 70 from displacing distally with respect to the injection solution container 30 at the first dosing position P1. Further, the injection device 10 is provided with a second plunger stop mechanism 14 2 adapted to stop the plunger 70 from displacing distally with respect to the injection solution container 30 from the first dosing position P1 at the second dosing position P2 (see FIG. 34d). The first and second dosing positions P1, P2 of the plunger 70 are the ​​​​​​​​​​​When the plunger 70 is displaced relative to the injection solution container 30 between the first dosing position P1 and the second dosing position P2, it is selected to be adapted to discharge a desired dose of the injection solution contained in the injection solution container 30 from the injection solution container 30. Thereby, during use of the injection device 10, the user displaces the plunger 70 in the distal direction relative to the injection solution container 30 until the plunger 70 reaches the first dosing position P1, so that the excess injection solution can be discharged from the injection solution container 30. When the first dosing position P1 is reached, the first plunger stop mechanism 140 stops the plunger 70 from being further displaced in the distal direction. As a result, the user is prevented from discharging the injection solution from the injection solution container excessively.

[0084] Then, the remaining injection solution contained in the injection solution container can be administered to the patient by further displacing the plunger 70 in the distal direction until the plunger 70 reaches the second dosing position P2. When the second dosing position P2 is reached, the second plunger stop mechanism 142 stops the plunger 70 from being further displaced in the distal direction, thereby preventing the injection solution from being administered to the patient excessively.

[0085]

[0085] In particular, as shown in FIGS. 12, 16 and 18, the first plunger stop mechanism 140 includes a dosing element 144 which is attached to the plunger 70 and is adapted to abut against a first dosing surface 146 provided on the first housing element 86. The dosing element 144 also forms part of the second plunger stop mechanism 142 and, as part of the second plunger stop mechanism 142, is also provided on the first housing element 86 with a second dosing surface 14 is adapted to abut against 8. The dosing element 144 is integrally formed with the plunger 70 and is designed in the form of a rib protruding from the lower surface of the actuating button 72 in the direction of the inner solution container 30 .

[0086] The first and second dosing surfaces 146, 148 extend substantially parallel to each other and parallel to the abutment surface 150 of the dosing element 144 which is substantially perpendicular to the longitudinal axis of the plunger 70 . The second dosing surface 148 is offset parallel to the first dosing surface 146 in the distal direction and is arranged. The distance S between the first dosing surface 146 and the second dosing surface 148 in the distal direction corresponds to the desired movement distance of the plunger 70 in the distal direction between the first dosing position P1 and the second dosing position P2 (see particularly FIG. 18). Thus, due to the distance S between the first dosing surface 146 and the second dosing surface 148 in the distal direction, when displacing the plunger 70 from the first dosing position P1 to the second dosing position P2, the desired injection volume to be discharged from the injection solution container 30 is set . Furthermore, the first and second dosing surfaces 146, 148 are offset from each other in the circumferential direction of the plunger 70 . Specifically, the second dosing surface 148 is defined by the bottom surface of a recess 152 formed in the first dosing surface 146 provided on the first housing element 86 .

[0087] When the plunger 70 moves distally from its filling position shown in FIG. 34a during use of the injection device 10 , when the plunger 70 reaches the first dosing position P1 as shown in FIG. 34b , the abutment surface 150 of the dosing element 144 abuts against the first dosing surface 146. The first of the dosing element 144

[0088] When the plunger 70 moves distally from its filling position shown in FIG. 34a during use of the injection device 10 , when the plunger 70 reaches the first dosing position P1 as shown in FIG. 34b , the abutment surface 150 of the dosing element 144 abuts against the first dosing surface 146. The first of the dosing element 144 ​The interaction with the dosing surface 146 prevents the plunger from being further displaced in the distal direction. Thereby, the first plunger stop mechanism 140 provides a hard stop for the plunger 70 at the first dosing position P1. Thus, the injection device 10 further comprises a plunger release mechanism 154, and the plunger release mechanism 154 is configured to deactivate the first plunger stop mechanism 140 so that the plunger 70 can be released and thus displaced relative to the injection solution container 30 in the distal direction from the first dosing position P1, i.e., in the direction of the second metering position P2.

[0089] The plunger release mechanism 154 is adapted to allow the dosing element 144 to move relative to the first dosing surface 146, i.e., to disengage the dosing element 144 from the first dosing surface 146. Specifically, the plunger release mechanism 154 is adapted to allow the first dosing surface 146 to rotate relative to the dosing element 144, i.e., to disengage the dosing element 144 from the first dosing surface 146. To allow the first dosing surface 146 to rotate relative to the dosing element 144, the first housing element 86 that supports the first and second dosing surfaces 146, 148 is designed to be manually rotatable relative to the second housing element 88 (see FIG. 34c). Since the plunger 70 is prevented from rotating relative to the second housing element 88 by the plunger guide 114, rotation of the first housing element 86 relative to the second housing element 88 necessarily results in rotation of the first housing element 86 relative to the plunger 70. ​​​​​​​​​​​​​​​​

[0090] Since it is rotatable relative to the second housing element 88 in an induction pattern, a holding recess 156 is provided in the first housing element 86 (see FIGS. 17, 18, and 24), and the holding recess 156 receives a holding element 158 formed on the second housing element 88 (see FIG. 20). Further, in order to simplify the handling of the plunger release mechanism 154, a gripping structure 159 is provided in a region of the outer surface of the first housing element 86. The gripping structure 159 is designed in the form of a gripping rib arrangement in which individual gripping ribs extend substantially in a direction along the longitudinal axis of the plunger 70. Since it is rotatable relative to the second housing element 88 in an induction pattern, a holding recess 156 is provided in the first housing element 86 (see FIGS. 17, 18, and 24), and the holding recess 156 receives a holding element 158 formed on the second housing element 88 (see FIG. 20). Further, in order to simplify the handling of the plunger release mechanism 154, a gripping structure 159 is provided in a region of the outer surface of the first housing element 86. The gripping structure 159 is designed in the form of a gripping rib arrangement in which individual gripping ribs extend substantially in a direction along the longitudinal axis of the plunger 70. Since it is rotatable relative to the second housing element 88 in an induction pattern, a holding recess 156 is provided in the first housing element 86 (see FIGS. 17, 18, and 24), and the holding recess 156 receives a holding element 158 formed on the second housing element 88 (see FIG. 20). Further, in order to simplify the handling of the plunger release mechanism 154, a gripping structure 159 is provided in a region of the outer surface of the first housing element 86. The gripping structure 159 is designed in the form of a gripping rib arrangement in which individual gripping ribs extend substantially in a direction along the longitudinal axis of the plunger 70. Since it is rotatable relative to the second housing element 88 in an induction pattern, a holding recess 156 is provided in the first housing element 86 (see FIGS. 17, 18, and 24), and the holding recess 156 receives a holding element 158 formed on the second housing element 88 (see FIG. 20). Further, in order to simplify the handling of the plunger release mechanism 154, a gripping structure 159 is provided in a region of the outer surface of the first housing element 86. The gripping structure 159 is designed in the form of a gripping rib arrangement in which individual gripping ribs extend substantially in a direction along the longitudinal axis of the plunger 70. Since it is rotatable relative to the second housing element 88 in an induction pattern, a holding recess 156 is provided in the first housing element 86 (see FIGS. 17, 18, and 24), and the holding recess 156 receives a holding element 158 formed on the second housing element 88 (see FIG. 20). Further, in order to simplify the handling of the plunger release mechanism 154, a gripping structure 159 is provided in a region of the outer surface of the first housing element 86. The gripping structure 159 is designed in the form of a gripping rib arrangement in which individual gripping ribs extend substantially in a direction along the longitudinal axis of the plunger 70. Since it is rotatable relative to the second housing element 88 in an induction pattern, a holding recess 156 is provided in the first housing element 86 (see FIGS. 17, 18, and 24), and the holding recess 156 receives a holding element 158 formed on the second housing element 88 (see FIG. 20). Further, in order to simplify the handling of the plunger release mechanism 154, a gripping structure 159 is provided in a region of the outer surface of the first housing element 86. The gripping structure 159 is designed in the form of a gripping rib arrangement in which individual gripping ribs extend substantially in a direction along the longitudinal axis of the plunger 70. Since it is rotatable relative to the second housing element 88 in an induction pattern, a holding recess 156 is provided in the first housing element 86 (see FIGS. 17, 18, and 24), and the holding recess 156 receives a holding element 158 formed on the second housing element 88 (see FIG. 20). Further, in order to simplify the handling of the plunger release mechanism 154, a gripping structure 159 is provided in a region of the outer surface of the first housing element 86. The gripping structure 159 is designed in the form of a gripping rib arrangement in which individual gripping ribs extend substantially in a direction along the longitudinal axis of the plunger 70.

[0091] The amount of rotation of the first housing element 86 relative to the second housing element 88, and thus relative to the plunger 70, is set such that the recess 152 formed in the first dosing surface 146 is aligned with the dosing element 144 protruding from the actuating button 72 of the plunger 70. Accordingly, the plunger release mechanism 154 is adapted to displace the first and second dosing surfaces 146, 148 in the circumferential direction of the plunger 70 in order to disengage the dosing element 144 from the first dosing surface 146 and at the same time align the second dosing surface 148 with the dosing element 144. The amount of rotation of the first housing element 86 relative to the second housing element 88, and thus relative to the plunger 70, is set such that the recess 152 formed in the first dosing surface 146 is aligned with the dosing element 144 protruding from the actuating button 72 of the plunger 70. Accordingly, the plunger release mechanism 154 is adapted to displace the first and second dosing surfaces 146, 148 in the circumferential direction of the plunger 70 in order to disengage the dosing element 144 from the first dosing surface 146 and at the same time align the second dosing surface 148 with the dosing element 144. The amount of rotation of the first housing element 86 relative to the second housing element 88, and thus relative to the plunger 70, is set such that the recess 152 formed in the first dosing surface 146 is aligned with the dosing element 144 protruding from the actuating button 72 of the plunger 70. Accordingly, the plunger release mechanism 154 is adapted to displace the first and second dosing surfaces 146, 148 in the circumferential direction of the plunger 70 in order to disengage the dosing element 144 from the first dosing surface 146 and at the same time align the second dosing surface 148 with the dosing element 144. The amount of rotation of the first housing element 86 relative to the second housing element 88, and thus relative to the plunger 70, is set such that the recess 152 formed in the first dosing surface 146 is aligned with the dosing element 144 protruding from the actuating button 72 of the plunger 70. Accordingly, the plunger release mechanism 154 is adapted to displace the first and second dosing surfaces 146, 148 in the circumferential direction of the plunger 70 in order to disengage the dosing element 144 from the first dosing surface 146 and at the same time align the second dosing surface 148 with the dosing element 144. The amount of rotation of the first housing element 86 relative to the second housing element 88, and thus relative to the plunger 70, is set such that the recess 152 formed in the first dosing surface 146 is aligned with the dosing element 144 protruding from the actuating button 72 of the plunger 70. Accordingly, the plunger release mechanism 154 is adapted to displace the first and second dosing surfaces 146, 148 in the circumferential direction of the plunger 70 in order to disengage the dosing element 144 from the first dosing surface 146 and at the same time align the second dosing surface 148 with the dosing element 144. The amount of rotation of the first housing element 86 relative to the second housing element 88, and thus relative to the plunger 70, is set such that the recess 152 formed in the first dosing surface 146 is aligned with the dosing element 144 protruding from the actuating button 72 of the plunger 70. Accordingly, the plunger release mechanism 154 is adapted to displace the first and second dosing surfaces 146, 148 in the circumferential direction of the plunger 70 in order to disengage the dosing element 144 from the first dosing surface 146 and at the same time align the second dosing surface 148 with the dosing element 144. The amount of rotation of the first housing element 86 relative to the second housing element 88, and thus relative to the plunger 70, is set such that the recess 152 formed in the first dosing surface 146 is aligned with the dosing element 144 protruding from the actuating button 72 of the plunger 70. Accordingly, the plunger release mechanism 154 is adapted to displace the first and second dosing surfaces 146, 148 in the circumferential direction of the plunger 70 in order to disengage the dosing element 144 from the first dosing surface 146 and at the same time align the second dosing surface 148 with the dosing element 144.

[0092] When the user activates the plunger release mechanism 154, the first housing element 86 is rotated in the correct direction relative to the second housing element 88 by the correct amount of rotation necessary to disengage the dosing element 144 from the first dosing surface 146 and at the same time align the second dosing surface 148 with the dosing element 144. To ensure this, the plunger release mechanism 154 is When the user activates the plunger release mechanism 154, the first housing element 86 is rotated in the correct direction relative to the second housing element 88 by the correct amount of rotation necessary to disengage the dosing element 144 from the first dosing surface 146 and at the same time align the second dosing surface 148 with the dosing element 144. To ensure this, the plunger release mechanism 154 is When the user activates the plunger release mechanism 154, the first housing element 86 is rotated in the correct direction relative to the second housing element 88 by the correct amount of rotation necessary to disengage the dosing element 144 from the first dosing surface 146 and at the same time align the second dosing surface 148 with the dosing element 144. To ensure this, the plunger release mechanism 154 is When the user activates the plunger release mechanism 154, the first housing element 86 is rotated in the correct direction relative to the second housing element 88 by the correct amount of rotation necessary to disengage the dosing element 144 from the first dosing surface 146 and at the same time align the second dosing surface 148 with the dosing element 144. To ensure this, the plunger release mechanism 154 is , a marker system 160 adapted to indicate the activation of the plunger release mechanism 154 comprises. The marker system 160 includes a first marker element 162 provided on the outer surface of the first housing element 86. The marker system 160 further includes a second marker element 164 provided on the outer surface of the second housing element 88. The first and second marker elements 162, 16 4 are positioned offset from each other circumferentially of the plunger 70 when the plunger release mechanism 154 is not actuated in the first and second housing elements 86, 88, but are positioned aligned with each other when the plunger release mechanism 154 is actuated in such a position that they are positioned. Compare FIGS. 34b and 34c.

[0093] The injection device 10 further comprises a limiting mechanism 166, which is adapted to disengage the dosing element 144 from the first dosing surface 146 and to align the dosing element 144 with the second dosing surface 146 by restricting the movement of the first and second dosing surfaces 146, 148 (see FIGS. 16 and 20). The limiting mechanism 166 comprises a first limiting element 168 provided on the first housing element 86 that supports the first and second dosing surfaces 146, 1 48. Furthermore, the limiting mechanism 166 comprises a second limiting element 170 provided on the second housing element 88 that remains stationary when the first housing element 86 rotates to stop the first plunger stop mechanism 140 in a stopped state. When the dosing element 144 is disengaged from the first dosing surface 146 by the rotation of the first housing element 86 relative to the plunger 70 and is aligned with the second dosing surface 148, the first limiting element 168 is the second limiting element 17 ​​​​​​​​abuts against 0. The limiting mechanism 166 prevents the user of the injection device 10 from rotating the first housing element 86 excessively with respect to the second housing element 88. Further, the limiting mechanism 1 66 provides tactile feedback to the user that the first plunger stop mechanism 140 has reached the stopped state.

[0094] The second drag mechanism 172 serves to apply a holding force to hold the first housing element 86 in its current position with respect to the second housing element 88. Due to the presence of the second drag mechanism 172, active manual actuation is required to rotate the first housing element 86 with respect to the second housing element 88. Thus, the second drag mechanism 172 prevents the first housing element 86 from being unintentionally displaced with respect to the second housing element 88, and thus prevents the plunger release mechanism 154 from being unintentionally actuated. The second drag mechanism 172 includes a friction element 174, which is provided on the first limiting element 168 of the limiting mechanism 166 and is adapted to interact with the holding element 158 of the second housing element 88 by friction.

[0095] The injection device 10 further includes an activation mechanism 176, which is adapted to prevent the activation of the plunger release mechanism 154 until the plunger 7 0 is disposed at the first dosing position P1, and is adapted to enable the activation of the plunger release mechanism 154 when the plunger 70 is disposed at the first dosing position P1 (see FIGS. 12, 16, and 19a). Specifically, the activation mechanism 176 prevents the rotation of the first housing element 86 with respect to the plunger 70, thereby preventing dosing until the plunger 70 is disposed at the first dosing position P1. The element 144 and the first dispensing surface 144 are prevented from moving relative to each other.

[0096] The actuation mechanism 176 includes a guide channel 94 that guides the plunger 70. The plunger 70 extends along the longitudinal axis of the injection solution container 30. Upon displacement of the plunger 70 relative to the guide element 92, the guide channel 94 is displaced relative to the guide element 92. The first housing element 86 receives the inductive element 92 provided therein. and the interaction of the opposing faces of the guide channel 94 with the plunger 70 and the first The housing elements 86 are prevented from rotating relative to one another. On the one hand, to allow the plunger 70 to be guided and displaced in the direction of the longitudinal axis. , and at the same time, when plunger 70 is not disposed in the first dispensing position, the first plunger The stopping mechanism 154 serves a dual function to prevent unintentional stopping.

[0097] The actuation mechanism 176 further comprises an actuation channel 178. The actuation channel 178 is A plunger branching off from the guide channel 94 and substantially perpendicular to the guide channel 94. The plunger 70 is disposed at the first dispensing position P1. When the first housing element 86 rotates relative to the plunger 70, the actuation channel 178 The plunger 70 receives the guide element 92. This allows the first dispensing position P1 of the plunger 70 to be The position of the actuation channel 178 along the longitudinal axis of the jar 70 .

[0098] Finally, the plunger release mechanism 154 further comprises a locking arrangement 180. 80 is for the first dosing surface 146 to be disengaged from the dosing element 144, so that after the dosing element 144 moves relative thereto, the first dosing surface 146 is locked in place relative to the dosing element 144 (see FIGS. 17, 21 and 25). Specifically, the locking arrangement 180 includes an elastic locking clip 182, which is provided on the second housing element 88 and when the first dosing surface 146 moves relative to the dosing element 144 so as to be disengaged from the dosing element 144, that is, when the first housing element 86 rotates relative to the second housing element 88, it is elastically pushed out from the rest position by interaction with a locking element 184 provided on the first housing element 86. After the movement of the first dosing surface 146 is completed, that is, after the rotation of the first housing element 86 is completed, the locking clip 182 deforms to return to its rest position and interacts with the locking element 184 to lock the first housing element 86 relative to the second housing element 88 and the plunger 70. In particular, the locking clip 182 interacts with the locking element 184 to prevent the first housing element 86 from rotating in the reverse direction relative to the second housing element 88 and the plunger 70 after the first housing element 86 has rotated once, so as to disengage the first dosing surface 146 from the dosing element 144 and

[0099] align the second dosing surface 148 with the dosing element 144. As a result, the first dosing surface 146 is locked in place relative to the dosing element 144. The locking arrangement 180 enables the plunger release mechanism 154 to be used only once to put the first plunger stop mechanism 140 in a stopped state. As a result, reuse of the injection device 10 is prevented. In particular, the locking clip 182 interacts with the locking element 184 to prevent the first housing element 86 from rotating in the reverse direction relative to the second housing element 88 and the plunger 70 after the first housing element 86 has rotated once, so as to disengage the first dosing surface 146 from the dosing element 144 and align the second dosing surface 148 with the dosing element 144. As a result, the first dosing surface 146 is locked in place relative to the dosing element 144. The locking arrangement 180 enables the plunger release mechanism 154 to be used only once to put the first plunger stop mechanism 140 in a stopped state. As a result, reuse of the injection device 10 is prevented. As a result, the first dosing surface 146 is locked in place relative to the dosing element 144. The locking arrangement 180 enables the plunger release mechanism 154 to be used only once to put the first plunger stop mechanism 140 in a stopped state. As a result, reuse of the injection device 10 is prevented. As a result, reuse of the injection device 10 is prevented.

[0100] With the plunger 70 disposed at the first dosing position P1, after the rotational movement of the first housing element 86 relative to the second housing element 88 is completed, the dosing element 144 is aligned with the recess 152 formed in the first dosing surface 146. As a result, the abutment surface 150 of the dosing element 144 is disposed parallel to the second dosing surface 148 at a distance S. As a result, the plunger 70 can be further displaced distally by a distance S within the second dosing position P2 from the first dosing position P1 until the dosing element 144, i.e., its abutment surface 150, abuts against the second dosing surface 148 (compare FIGS. 34c and 34d). Similar to the first plunger stop mechanism 140, the second plunger stop mechanism 142 also provides a hard stop for the plunger 70, i.e., prevents the plunger 70 from being displaced distally from the second dosing position P2 relative to the injection solution container 30. Thus, the dose of the injection solution to be administered to the patient can be set in a particularly accurate manner. After the rotational movement of the first housing element 86 relative to the second housing element 88 is completed with the plunger 70 disposed at the first dosing position P1, the dosing element 144 is aligned with the recess 152 formed in the first dosing surface 146. As a result, the abutment surface 150 of the dosing element 144 is disposed parallel to the second dosing surface 148 at a distance S. As a result, the plunger 70 can be further displaced distally by a distance S within the second dosing position P2 from the first dosing position P1 until the dosing element 144, i.e., its abutment surface 150, abuts against the second dosing surface 148 (compare FIGS. 34c and 34d). Similar to the first plunger stop mechanism 140, the second plunger stop mechanism 142 also provides a hard stop for the plunger 70, i.e., prevents the plunger 70 from being displaced distally from the second dosing position P2 relative to the injection solution container 30. Thus, the dose of the injection solution to be administered to the patient can be set in a particularly accurate manner. Similar to the first plunger stop mechanism 140, the second plunger stop mechanism 142 also provides a hard stop for the plunger 70, i.e., prevents the plunger 70 from being displaced distally from the second dosing position P2 relative to the injection solution container 30. Thus, the dose of the injection solution to be administered to the patient can be set in a particularly accurate manner. Similar to the first plunger stop mechanism 140, the second plunger stop mechanism 142 also provides a hard stop for the plunger 70, i.e., prevents the plunger 70 from being displaced distally from the second dosing position P2 relative to the injection solution container 30. Thus, the dose of the injection solution to be administered to the patient can be set in a particularly accurate manner. Similar to the first plunger stop mechanism 140, the second plunger stop mechanism 142 also provides a hard stop for the plunger 70, i.e., prevents the plunger 70 from being displaced distally from the second dosing position P2 relative to the injection solution container 30.

[0101] FIGS. 35a - 35c show exploded views of injection devices according to various examples. With respect to FIGS. 35a - 35c, FIGS. 36a - 36c showing the use of the injection device according to various examples will be described hereinafter with reference thereto simultaneously. As shown in FIG. 35a, the injection device 200 includes an injection solution container 202, a plunger 204, a tip element 206, and a housing 208. In some examples, the injection solution transfer system 100 includes the injection device 200 instead of the injection device 10. The injection device 200 has similar functionality as the injection device 10 (e.g., accurately administering a microdose of injection solution to a patient). With respect to FIGS. 35a - 35c, FIGS. 36a - 36c showing the use of the injection device according to various examples will be described hereinafter with reference thereto simultaneously.

[0102] As shown in FIG. 35a, the injection device 200 includes an injection solution container 202, a plunger 204, a tip element 206, and a housing 208. In some examples, the injection solution transfer system 100 includes the injection device 200 instead of the injection device 10. The injection device 200 has similar functionality as the injection device 10 (e.g., accurately administering a microdose of injection solution to a patient). In some examples, the injection solution transfer system 100 includes the injection device 200 instead of the injection device 10. Providing accurate and reliable administration), and injecting in a manner similar to the injection device 10 Interacts with other components of the solution transfer system 100 (e.g., the filling adapter 12) However, unlike the injection device 10, the injection device 200 is reusable So as to be configured (e.g., to be used to quantitatively discharge and / or inject the injection solution more than once) Furthermore, the injection device 200 has a more intuitive design that is shown to reduce user errors (e.g., when quantitatively discharging and / or injecting the injection solution)

[0103] Similar to the injection solution container 30 of the injection device 10, the injection solution container 202 of the injection device 200 Is designed in the form of an inner injection solution container 210 housed within a protective outer barrel 212 The inner injection solution container 210 and the protective outer barrel 212 are integrally formed with each other and are made of a sterilized plastic material The protective outer barrel 212 includes a flange element 214 in the region of its proximal end

[0104] In some examples, the surface of the inner injection solution container 210 (e.g., the inner circumferential surface) is coated with a plasma-enhanced chemical vapor deposition (PECVD) coating or a treatment useful for providing a smooth lubricating layer In some examples, the surface of the inner injection solution container 210 (e.g., the inner circumferential surface) Is coated with a lubricant coating created from a PECVD process using octamethylcyclotetrasiloxane (OMCTS) as a precursor In some examples, the injection solution container 202 / inner injection solution container 210 is at least under ISO class 8 conditions during operation and ISO class 7 conditions during rest, in accordance with ISO 14644 4 manufactured by a PECVD process using high-frequency power composed of silicon, carbon, and oxygen under PECVD coating and treatment are known in the art and are described in at least the following U.S. patents, each of which is incorporated herein by reference in its entirety: U.S. Patent No. 10,390,744, U.S. Patent No. 10,363,3 70, U.S. Patent No. 10,327,986, U.S. Patent No. 10,258,718 , U.S. Patent No. 10,201,660, U.S. Patent No. 10,189,603, U.S. Patent No. 10, 059,047, U.S. Patent No. 10,016,338, U.S. Patent No. 9,981,794 , U.S. Patent No. 9,952,147, U.S. Patent No. 9,937,099, U.S. Patent No. 9 ,903,782, U.S. Patent No. 9,878,101, U.S. Patent No. 9,863,042 , U.S. Patent No. 9,855,577, U.S. Patent No. 9,764,093, U.S. Patent No. 9 ,664,626, U.S. Patent No. 9,662,450, U.S. Patent No. 9,572,526 , U.S. Patent No. 9,554,968, U.S. Patent No. 9,545,360, U.S. Patent No. 9 ,554,968, U.S. Patent No. 9,545,360, U.S. Patent No. 9 ,475,225, U.S. Patent No. 9,458,536, U.S. Patent No. 9,381,687 , U.S. Patent No. 9,345,846, U.S. Patent No. 9,272,095 and U.S. Patent No. 8,83 4,954.

[0105] At the distal end of the injection solution container 202, a male luer taper 216 and a luer thread 218 are provided, which are respectively a female luer taper and a complementary luer thread (e.g., when the filling adapter 12 is connected to the injection device 200, the female luer taper 50 and the complementary luer provided at the second connection port 22 of the adapter element 18 of the filling adapter 12 thread, for example, thread). - interacts with the thread 54). Using the luer taper 216 and the luer thread 218, a fluid-tight connection can be established between the distal end of the injection solution container 202 and a component having a female luer taper and a complementary luer thread (e.g., the adapter element 18 of the filling adapter 12).

[0106] The outer barrel 212 further includes a clip receiver 220. The clip receiver 220 is configured to be releasably connected to the housing clip 234 of the housing 208 (as will be described in more detail later). In some examples, the outer barrel 212 does not include a clip receiver 220. In these examples, the housing clip 234 is directly releasably connected to the outer peripheral surface of the outer barrel 212.

[0107] In some examples, the diameter 222 of the inner injection solution container 210 is increased or decreased based on the amount (e.g., volume) of the injection solution to be delivered and / or injected quantitatively. In other words, in some examples, the diameter 222 of the inner injection solution container 210 is increased or decreased to increase or decrease the amount of the injection solution to be delivered quantitatively by the injection device 200. For example, as shown in FIG. 35b, the diameter 222 is increased (e.g., doubled) so that the inner injection solution container 210 holds and can later deliver quantitatively an increased amount of the solution. To increase or decrease the diameter 222, it is necessary to increase or decrease the diameter of the outer barrel 212 and the diameter of the tip element 206. For example, as shown in FIG. 35b, the outer barrel 212 houses the inner injection solution container 210, and the tip element 206 is associated with the increase in the diameter 222. so as to seal with (as will be described in more detail later) the inner peripheral surface of the inner injection solution container 210 and interact with each other, increase the diameters of the outer barrel 212 and the tip element 206. In some examples, the length of the injection solution container 202 (and thus the length of the inner injection solution container 210) is increased or decreased based on the amount (e.g., volume) of the injection solution to be dispensed and / or injected. By increasing or decreasing the diameter and / or length of the inner injection solution container 210 as described above, the total amount of the injection solution that can be accommodated in the inner injection solution container 210 increases or decreases. For example, depending on the diameter and length of the inner injection solution container 210, the inner injection solution container 210 can accommodate any amount between 100 μL and 1000 μL. In one embodiment, the inner injection solution container 210 can accommodate at least 100 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate at least 200 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate at least 300 μL of the injection solution. The inner injection solution container 210 can accommodate at least 400 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate at least 500 μL of the injection solution. The inner injection solution container 210 can accommodate at least 600 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate at least 700 μL of the injection solution. The inner injection solution container 210 can accommodate at least 800 μL of the injection solution. As described above, by increasing or decreasing the diameter and / or length of the inner injection solution container 210, the total amount of the injection solution that can be accommodated in the inner injection solution container 210 increases or decreases. For example, depending on the diameter and length of the inner injection solution container 210, the inner injection solution container 210 can accommodate any amount between 100 μL and 1000 μL. Reduce.

[0108] As described above, by increasing or decreasing the diameter and / or length of the inner injection solution container 210, the total amount of the injection solution that can be accommodated in the inner injection solution container 210 increases or decreases. For example, depending on the diameter and length of the inner injection solution container 210, the inner injection solution container 210 can accommodate any amount between 100 μL and 1000 μL. Thereby, the total amount of the injection solution that can be accommodated in the inner injection solution container 210 increases or decreases. For example, depending on the diameter and length of the inner injection solution container 210, the inner injection solution container 210 can accommodate any amount between 100 μL and 1000 μL. For example, depending on the diameter and length of the inner injection solution container 210, the inner injection solution container 210 can accommodate any amount between 100 μL and 1000 μL. In one embodiment, the inner injection solution container 210 can accommodate any amount between 100 μL and 1000 μL.

[0109] In one embodiment, the inner injection solution container 210 can accommodate at least 100 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate at least 200 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate at least 300 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate at least 400 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate at least 500 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate at least 500 μL of the injection solution. The inner injection solution container 210 can accommodate at least 600 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate at least 700 μL of the injection solution. The inner injection solution container 210 can accommodate at least 800 μL of the injection solution. It can accommodate. In one embodiment, the inner injection solution container 210 can accommodate at least 9 00 μL of the injection solution. The inner injection solution container 210 can accommodate at least 1 000 μL of the injection solution.

[0110] In one embodiment, the inner injection solution container 210 can accommodate 100 - 900 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 100 - 800 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 100 - 700 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 100 - 600 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 100 - 500 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 100 - 400 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 10 0 - 300 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 100 - 200 μL of the injection solution.

[0111] In one embodiment, the inner injection solution container 210 can accommodate 200 - 1000 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 300 - 10 00 μL of the injection solution. In one embodiment, the inner injection solution container 2 10 can accommodate 400 - 1000 μL of the injection solution. In one embodiment , the inner injection solution container 210 can accommodate 500 - 1000 μL of the injection solution. . In one embodiment, the inner injection solution container 210 can accommodate an injection solution of 600 to 1000 μL and can accommodate an injection solution of 700 to 10 00 μL. In one embodiment, the inner injection solution container 2 10 can accommodate an injection solution of 800 to 1000 μL. In one embodiment , the inner injection solution container 210 can accommodate an injection solution of 900 to 1000 μL .

[0112] In one embodiment, the inner injection solution container 210 can accommodate an injection solution of 200 to 900 μL and can accommodate an injection solution of 300 to 800 μL. In one embodiment, the inner injection solution container 210 can accommodate an injection solution of 400 to 700 μL. In one embodiment, the inner injection solution container 210 can accommodate an injection solution of 500 to 600 μL.

[0113] In one embodiment, the inner injection solution container 210 can accommodate an injection solution of 100 to 200 μL and can accommodate an injection solution of 200 to 300 μL. In one embodiment, the inner injection solution container 210 can accommodate an injection solution of 300 to 400 μL. In one embodiment, the inner injection solution container 210 can accommodate an injection solution of 400 to 500 μL. In one embodiment, the inner injection solution container 210 can accommodate an injection solution of 500 to 600 μL and can accommodate an injection solution of 600 to 700 μL It is possible to accommodate the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 70 to 800 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 800 to 900 μL of the injection solution. In one embodiment the inner injection solution container 210 can accommodate 900 to 1000 μL of the injection solution. It is possible.

[0114] In one embodiment, the inner injection solution container 210 can accommodate 100 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 200 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 300 μL of the injection solution. The inner injection solution container 210 can accommodate 400 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 500 μL of the injection solution. The inner injection solution container 210 can accommodate 600 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 700 μL of the injection solution. The inner injection solution container 210 can accommodate 800 μL of the injection solution. In one embodiment, the inner injection solution container 210 can accommodate 900 μL of the injection solution. The inner injection solution container 210 can accommodate 1000 μL of the injection solution. It is possible to accommodate.

[0115] The injection device 200 can be configured to quantitatively discharge a predetermined ratio (for example, a predetermined ratio of 2.5% to 12.5%) of the total volume of the injection solution accommodated in the inner injection solution container 210, and as will be described in more detail with reference to FIG. 36c, when using the injection device 200 It can be configured to discharge a predetermined ratio (for example, a predetermined ratio of 2.5% to 12.5%) of the total volume of the injection solution accommodated in the inner injection solution container 210, and as will be described in more detail with reference to FIG. 36c, when using the injection device 200 it can be configured to quantitatively discharge a predetermined ratio (for example, a predetermined ratio of 2.5% to 12.5%) of the total volume of the injection solution accommodated in the inner injection solution container 210, and as will be described in more detail with reference to FIG. 36c, when using the injection device 200 The user can quickly and easily change the metered discharge and / or the amount (e.g., volume) of the injection solution to be injected by replacing the injection solution container 202 of the injection device 200 with another injection solution container 202 that can hold a greater or lesser total volume of the injection solution. For example, if the injection device 200 is configured to deliver 12.5% of the total injection solution volume contained in the inner injection solution container 210, the injection device 200 will meteredly discharge and / or inject 50 μL of the injection solution if the inner injection solution container 210 contains 400 μL of the injection solution, and 25 μL of the injection solution if the inner injection solution container 210 contains 200 μL of the injection solution. Returning to FIG. 35a, the injection device 200 further includes a plunger 204. The plunger 204 includes an actuation button 224, a plunger flange 226, one or more guide channels 227, a plunger rod 228, one or more activation channels 229, and a tip bearing 230. Similar to the plunger 70 of the injection device 10, the plunger 204 is configured such that at least a portion of the plunger 204 (e.g., at least a portion of the plunger rod 228) is slidably received within the inner injection solution container 210 of the injection solution container 202. Further, the plunger 204 is displaceable distally relative to the injection solution container 202 along the longitudinal axis of the plunger 204 to discharge the injection solution contained within the injection solution container 202. However, unlike the plunger 70, the plunger 204 is rotatable about the longitudinal axis of the plunger 204 after the inner injection solution container 210 has slidably received at least a portion of the plunger 204 (as will be described in more detail later). When the inner injection solution container 210 contains 400 μL of the injection solution, it will inject 50 μL of the injection solution, and when the inner injection solution container 210 contains 200 μL of the injection solution, it will inject 25 μL of the injection solution, for metered discharge and / or injection.

[0116] Returning to FIG. 35a, the injection device 200 further includes a plunger 204. The plunger 204 includes an actuation button 224, a plunger flange 226, one or more guide channels 227, a plunger rod 228, one or more activation channels 229, and a tip bearing 230. Similar to the plunger 70 of the injection device 10, the plunger 204 is configured such that at least a portion of the plunger 204 (e.g., at least a portion of the plunger rod 228) is slidably received within the inner injection solution container 210 of the injection solution container 202. Further, the plunger 204 is displaceable distally relative to the injection solution container 202 along the longitudinal axis of the plunger 204 to discharge the injection solution contained within the injection solution container 202. However, unlike the plunger 70, the plunger 204 is rotatable about the longitudinal axis of the plunger 204 after the inner injection solution container 210 has slidably received at least a portion of the plunger 204 (as will be described in more detail later). Further, the plunger 204 is displaceable distally relative to the injection solution container 202 along the longitudinal axis of the plunger 204 to discharge the injection solution contained within the injection solution container 202. However, unlike the plunger 70, the plunger 204 is rotatable about the longitudinal axis of the plunger 204 after the inner injection solution container 210 has slidably received at least a portion of the plunger 204 (as will be described in more detail later). However, unlike the plunger 70, the plunger 204 is rotatable about the longitudinal axis of the plunger 204 after the inner injection solution container 210 has slidably received at least a portion of the plunger 204 (as will be described in more detail later). However, unlike the plunger 70, the plunger 204 is rotatable about the longitudinal axis of the plunger 204 after the inner injection solution container 210 has slidably received at least a portion of the plunger 204 (as will be described in more detail later). 04, and about the longitudinal axis of the plunger 204 after the inner injection solution container 210 has slidably received at least a portion of the plunger 204 (as will be described in more detail later). is configured to rotate (e.g., clockwise and counterclockwise).

[0117] The actuation button 224 is positioned at the proximal end of a plunger 204 that projects in a proximal direction from the injection solution container 202. The actuation button 224 is positioned along the longitudinal axis of the plunger 204 and is depressed by a user to displace the plunger 204 in a distal direction relative to the injection solution container 202 in the distal direction along the longitudinal axis of the plunger 204. As shown in FIG. 35a, the actuation button 224 includes a plurality of ridges that assist the user in rotating the plunger 204. In some examples, the actuation button 224 does not include a plurality of ridges (e.g., similar to the actuation button 72). for displacing the plunger 204 in a distal direction relative to the injection solution container 202 along the longitudinal axis of the plunger 204 and is depressed by a user. As shown in FIG. 35a, the actuation button 224 includes a plurality of ridges that assist the user in rotating the plunger 204. In some examples, the actuation button 224 does not include a plurality of ridges (e.g., similar to the actuation button 72). The plunger flange 226 is positioned at the proximal end of the plunger 204 below the actuation button 224. As will be described in more detail hereinafter (e.g., with reference to FIGS. 36a and 36b), the plunger flange 226 is configured to interact with a plunger stop mechanism 238 such that, based on the longitudinal position and / or the rotational orientation of the plunger flange 226, the plunger stop mechanism 238 prevents the plunger 204 from displacing in a distal direction along the longitudinal axis of the plunger 204 and / or prevents the plunger 204 from rotating clockwise and / or counterclockwise about the longitudinal axis of the plunger 204. The plunger flange 226 is rectangular in shape in FIG. 35a, but in some examples, the plunger flange 226 has a different shape (e.g., triangular, diamond-shaped, oval, etc.). Further, the plunger flange 226 is positioned directly below the actuation button 224, but in some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction). The plunger flange 226 is positioned at the proximal end of the plunger 204 below the actuation button 224. As will be described in more detail hereinafter (e.g., with reference to FIGS. 36a and 36b), the plunger flange 226 is configured to interact with a plunger stop mechanism 238 such that, based on the longitudinal position and / or the rotational orientation of the plunger flange 226, the plunger stop mechanism 238 prevents the plunger 204 from displacing in a distal direction along the longitudinal axis of the plunger 204 and / or prevents the plunger 204 from rotating clockwise and / or counterclockwise about the longitudinal axis of the plunger 204. The plunger flange 226 is rectangular in shape in FIG. 35a, but in some examples, the plunger flange 226 has a different shape (e.g., triangular, diamond-shaped, oval, etc.). Further, the plunger flange 226 is positioned directly below the actuation button 224, but in some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction). The plunger flange 226 is positioned at the proximal end of the plunger 204 below the actuation button 224. As will be described in more detail hereinafter (e.g., with reference to FIGS. 36a and 36b), the plunger flange 226 is configured to interact with a plunger stop mechanism 238 such that, based on the longitudinal position and / or the rotational orientation of the plunger flange 226, the plunger stop mechanism 238 prevents the plunger 204 from displacing in a distal direction along the longitudinal axis of the plunger 204 and / or prevents the plunger 204 from rotating clockwise and / or counterclockwise about the longitudinal axis of the plunger 204. The plunger flange 226 is rectangular in shape in FIG. 35a, but in some examples, the plunger flange 226 has a different shape (e.g., triangular, diamond-shaped, oval, etc.). Further, the plunger flange 226 is positioned directly below the actuation button 224, but in some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction).

[0118] The plunger flange 226 is positioned at the proximal end of the plunger 204 below the actuation button 224. As will be described in more detail hereinafter (e.g., with reference to FIGS. 36a and 36b), the plunger flange 226 is configured to interact with a plunger stop mechanism 238 such that, based on the longitudinal position and / or the rotational orientation of the plunger flange 226, the plunger stop mechanism 238 prevents the plunger 204 from displacing in a distal direction along the longitudinal axis of the plunger 204 and / or prevents the plunger 204 from rotating clockwise and / or counterclockwise about the longitudinal axis of the plunger 204. The plunger flange 226 is rectangular in shape in FIG. 35a, but in some examples, the plunger flange 226 has a different shape (e.g., triangular, diamond-shaped, oval, etc.). Further, the plunger flange 226 is positioned directly below the actuation button 224, but in some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction). The plunger flange 226 is positioned at the proximal end of the plunger 204 below the actuation button 224. As will be described in more detail hereinafter (e.g., with reference to FIGS. 36a and 36b), the plunger flange 226 is configured to interact with a plunger stop mechanism 238 such that, based on the longitudinal position and / or the rotational orientation of the plunger flange 226, the plunger stop mechanism 238 prevents the plunger 204 from displacing in a distal direction along the longitudinal axis of the plunger 204 and / or prevents the plunger 204 from rotating clockwise and / or counterclockwise about the longitudinal axis of the plunger 204. The plunger flange 226 is rectangular in shape in FIG. 35a, but in some examples, the plunger flange 226 has a different shape (e.g., triangular, diamond-shaped, oval, etc.). Further, the plunger flange 226 is positioned directly below the actuation button 224, but in some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction). As will be described in more detail hereinafter (e.g., with reference to FIGS. 36a and 36b), the plunger flange 226 is configured to interact with a plunger stop mechanism 238 such that, based on the longitudinal position and / or the rotational orientation of the plunger flange 226, the plunger stop mechanism 238 prevents the plunger 204 from displacing in a distal direction along the longitudinal axis of the plunger 204 and / or prevents the plunger 204 from rotating clockwise and / or counterclockwise about the longitudinal axis of the plunger 204. The plunger flange 226 is rectangular in shape in FIG. 35a, but in some examples, the plunger flange 226 has a different shape (e.g., triangular, diamond-shaped, oval, etc.). Further, the plunger flange 226 is positioned directly below the actuation button 224, but in some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction). The plunger flange 226 is configured to interact with a plunger stop mechanism 238 such that, based on the longitudinal position and / or the rotational orientation of the plunger flange 226, the plunger stop mechanism 238 prevents the plunger 204 from displacing in a distal direction along the longitudinal axis of the plunger 204 and / or prevents the plunger 204 from rotating clockwise and / or counterclockwise about the longitudinal axis of the plunger 204. The plunger flange 226 is rectangular in shape in FIG. 35a, but in some examples, the plunger flange 226 has a different shape (e.g., triangular, diamond-shaped, oval, etc.). Further, the plunger flange 226 is positioned directly below the actuation button 224, but in some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction). The plunger flange 226 is configured to interact with a plunger stop mechanism 238 such that, based on the longitudinal position and / or the rotational orientation of the plunger flange 226, the plunger stop mechanism 238 prevents the plunger 204 from displacing in a distal direction along the longitudinal axis of the plunger 204 and / or prevents the plunger 204 from rotating clockwise and / or counterclockwise about the longitudinal axis of the plunger 204. The plunger flange 226 is rectangular in shape in FIG. 35a, but in some examples, the plunger flange 226 has a different shape (e.g., triangular, diamond-shaped, oval, etc.). Further, the plunger flange 226 is positioned directly below the actuation button 224, but in some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction). The plunger flange 226 is configured to interact with a plunger stop mechanism 238 such that, based on the longitudinal position and / or the rotational orientation of the plunger flange 226, the plunger stop mechanism 238 prevents the plunger 204 from displacing in a distal direction along the longitudinal axis of the plunger 204 and / or prevents the plunger 204 from rotating clockwise and / or counterclockwise about the longitudinal axis of the plunger 204. The plunger flange 226 is rectangular in shape in FIG. 35a, but in some examples, the plunger flange 226 has a different shape (e.g., triangular, diamond-shaped, oval, etc.). Further, the plunger flange 226 is positioned directly below the actuation button 224, but in some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction). The plunger flange 226 is configured to interact with a plunger stop mechanism 238 such that, based on the longitudinal position and / or the rotational orientation of the plunger flange 226, the plunger stop mechanism 238 prevents the plunger 204 from displacing in a distal direction along the longitudinal axis of the plunger 204 and / or prevents the plunger 204 from rotating clockwise and / or counterclockwise about the longitudinal axis of the plunger 204. The plunger flange 226 is rectangular in shape in FIG. 35a, but in some examples, the plunger flange 226 has a different shape (e.g., triangular, diamond-shaped, oval, etc.). Further, the plunger flange 226 is positioned directly below the actuation button 224, but in some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction). The plunger flange 226 is rectangular in shape in FIG. 35a, but in some examples, the plunger flange 226 has a different shape (e.g., triangular, diamond-shaped, oval, etc.). Further, the plunger flange 226 is positioned directly below the actuation button 224, but in some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction). The plunger flange 226 is rectangular in shape in FIG. 35a, but in some examples, the plunger flange 226 has a different shape (e.g., triangular, diamond-shaped, oval, etc.). Further, the plunger flange 226 is positioned directly below the actuation button 224, but in some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction). The plunger flange 226 is positioned directly below the actuation button 224, but in some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction). In some examples, the plunger flange 226 is on the plunger rod 228 (in the distal direction). ) It is positioned further below the longitudinal axis of the plunger 204. For example, the plunger flange 226 may be positioned at the midpoint of the plunger rod 228.

[0119] The plunger rod 228 of the plunger 204 is connected at its distal end to the tip element 206 of the injection device 200. The tip element 206 is identical to the tip element 74 (described in more detail with reference to FIG. 13). Further, the tip element 206 is connected to the plunger 204 in a manner similar to how the tip element 74 is connected to the plunger 70. Specifically, the connection between the plunger rod 228 and the tip element 206 is effected by the interaction between the tip hook 230 positioned at the distal end of the plunger rod 228 and the hook receiver (e.g., hook receiver 80) of the tip element 206. The sealing element (e.g., sealing element 82) of the tip element 206 interacts to seal against the inner circumferential surface of the inner injection solution container 210.

[0120] The housing 208 of the injection device 200 includes a flange receiver 232, a housing clip 234, a plunger through-hole 236, and a plunger stop mechanism 238. The housing 2 08 is releasably connected to the injection solution container 202 and is configured to slidably receive the plunger 204.

[0121] The housing 208 is releasably connected to the injection solution container 202 via (1) the interaction between the flange receiver 232 and the flange element 214 and (2) the interaction between the housing clip 234 and the clip receiver 220, as shown in FIGS. 36a and 36b, for example. Specifically, the flange receiver 232 is sized to receive the flange element 214. Specifically, the flange receiver 232 is sized to receive the flange element 214. In that example, it has a suitable shape and dimensions so as to hold the flange element 214 in place. Furthermore, the housing clip 234 is configured to be removably connected to the clip receiver 220 of the injection solution container 202 (as shown, for example, in FIGS. 36a and 36b). In the above-described example where the outer barrel 212 does not include the clip receiver 220, the housing clip 234 is removably directly connected to the outer peripheral surface of the outer barrel 212. By connecting the injection solution container 202 and the housing 208 as described above, the housing 208 can be easily and quickly detached from the injection solution container 202, and in some examples, (for example, when the plunger 204 is not inserted into the injection solution container 202 and the housing 208) it can be exchanged for another housing. The plunger through-hole 236 is sized to slidably receive the plunger rod 228 such that the inner injection solution container 210 can slidably receive the plunger 204 through the plunger through-hole 236 (for example, with the tip element 206 attached to the plunger rod 228). In this way, the plunger 204 is displaceable relative to the housing 208 and the injection solution container 202 in a direction along its longitudinal axis.

[0122] In some examples, the housing 208 includes one or more guiding elements (not shown) that project into the plunger through-hole 236. In some examples, one or more guiding elements of the housing 208 are the same as the guiding elements 92 of the first housing element 86 (described above with reference to FIG. 16, for example). When the plunger 204 is in the plunger through-hole 236 of the housing 208

[0123] When received within the plunger rod 228, each guide element is positioned on a surface of the plunger rod 228. A guide channel 222 is formed in the plunger rod 228 and extends along the longitudinal axis of the plunger rod 228. 7. Opposing one or more guide elements and their corresponding guide channels 227 Each guide element interacts with a corresponding side surface on the surface of plunger rod 228. The plunger 204 and the housing 208 are rotated relative to each other until aligned with the actuation channel 229. The rotation relative to the

[0124] Each actuation channel 229 on the surface of the plunger rod 228 extends from a guide channel 227 The plunger rod 22 is bifurcated and substantially perpendicular to its corresponding guide channel 227. In some examples, one on the surface of the plunger rod 228 extends circumferentially. Alternatively, the actuation channels 229 are identical to the actuation channels 178 of the plunger 70 . Each actuation channel 229 is aligned such that the plunger 204 (1) extends along the longitudinal axis of the plunger 204; (2) the plunger 204 is rotated in a first direction about the longitudinal axis of the plunger 204 to be disposed at a first dispensing position P1; When the rotational orientation, angular position, or rotational attitude about the longitudinal axis is O1, For example, FIG. 36a shows the first dispensing position P1 and the first direction 1 shows plunger 204 at O1.

[0125] To this end, the housing 208 contains one or more guide elements and the plunger rod 22 In the example where the plunger 8 includes one or more guide channels 227 / actuation channels 229, The first dosing position P1 of 204 may be one or more positions along the longitudinal axis of the plunger rod 228. The distance between the first and second actuation channels 229 is at least partially defined by the position of the first and second actuation channels 229. One or more activation channels 229 are positioned on the plunger rod 228 such that, when the plunger flange 226 contacts the plunger stop mechanism 238 (as shown, for example, in FIG. 36a), one or more guide elements are aligned with one or more activation channels 229. Accordingly, the interaction between the one or more guide elements and the guide channel 227 serves a dual function of enabling the plunger 204 to be guided and displaced in a direction along its longitudinal axis and, at the same time, preventing the plunger 204 from rotating inadvertently when it is not positioned at the first dosing position P1 in the first orientation O1. This makes the use of the injection device 200 easier and thus reduces user errors (e.g., when metering and / or injecting an injection solution). When the plunger flange 226 contacts the plunger stop mechanism 238, one or more guide elements are aligned with one or more activation channels 229, as shown in FIG. 36a for example. One or more activation channels 229 are positioned on the plunger rod 228 such that, when the plunger flange 226 contacts the plunger stop mechanism 238 (as shown, for example, in FIG. 36a), one or more guide elements are aligned with one or more activation channels 229. Accordingly, the interaction between the one or more guide elements and the guide channel 227 serves a dual function of enabling the plunger 204 to be guided and displaced in a direction along its longitudinal axis and, at the same time, preventing the plunger 204 from rotating inadvertently when it is not positioned at the first dosing position P1 in the first orientation O1. This makes the use of the injection device 200 easier and thus reduces user errors (e.g., when metering and / or injecting an injection solution). One or more activation channels 229 are positioned on the plunger rod 228 such that, when the plunger flange 226 contacts the plunger stop mechanism 238 (as shown, for example, in FIG. 36a), one or more guide elements are aligned with one or more activation channels 229. Accordingly, the interaction between the one or more guide elements and the guide channel 227 serves a dual function of enabling the plunger 204 to be guided and displaced in a direction along its longitudinal axis and, at the same time, preventing the plunger 204 from rotating inadvertently when it is not positioned at the first dosing position P1 in the first orientation O1. This makes the use of the injection device 200 easier and thus reduces user errors (e.g., when metering and / or injecting an injection solution). One or more activation channels 229 are positioned on the plunger rod 228 such that, when the plunger flange 226 contacts the plunger stop mechanism 238 (as shown, for example, in FIG. 36a), one or more guide elements are aligned with one or more activation channels 229. Accordingly, the interaction between the one or more guide elements and the guide channel 227 serves a dual function of enabling the plunger 204 to be guided and displaced in a direction along its longitudinal axis and, at the same time, preventing the plunger 204 from rotating inadvertently when it is not positioned at the first dosing position P1 in the first orientation O1. This makes the use of the injection device 200 easier and thus reduces user errors (e.g., when metering and / or injecting an injection solution). One or more activation channels 229 are positioned on the plunger rod 228 such that, when the plunger flange 226 contacts the plunger stop mechanism 238 (as shown, for example, in FIG. 36a), one or more guide elements are aligned with one or more activation channels 229. Accordingly, the interaction between the one or more guide elements and the guide channel 227 serves a dual function of enabling the plunger 204 to be guided and displaced in a direction along its longitudinal axis and, at the same time, preventing the plunger 204 from rotating inadvertently when it is not positioned at the first dosing position P1 in the first orientation O1. This makes the use of the injection device 200 easier and thus reduces user errors (e.g., when metering and / or injecting an injection solution). One or more activation channels 229 are positioned on the plunger rod 228 such that, when the plunger flange 226 contacts the plunger stop mechanism 238 (as shown, for example, in FIG. 36a), one or more guide elements are aligned with one or more activation channels 229. Accordingly, the interaction between the one or more guide elements and the guide channel 227 serves a dual function of enabling the plunger 204 to be guided and displaced in a direction along its longitudinal axis and, at the same time, preventing the plunger 204 from rotating inadvertently when it is not positioned at the first dosing position P1 in the first orientation O1. This makes the use of the injection device 200 easier and thus reduces user errors (e.g., when metering and / or injecting an injection solution). One or more activation channels 229 are positioned on the plunger rod 228 such that, when the plunger flange 226 contacts the plunger stop mechanism 238 (as shown, for example, in FIG. 36a), one or more guide elements are aligned with one or more activation channels 229. Accordingly, the interaction between the one or more guide elements and the guide channel 227 serves a dual function of enabling the plunger 204 to be guided and displaced in a direction along its longitudinal axis and, at the same time, preventing the plunger 204 from rotating inadvertently when it is not positioned at the first dosing position P1 in the first orientation O1. This makes the use of the injection device 200 easier and thus reduces user errors (e.g., when metering and / or injecting an injection solution).

[0126] The plunger stop mechanism 238 is positioned on the proximal surface of the housing 208 adjacent to (e.g., at least partially surrounding) the plunger through-hole 236. The plunger stop mechanism 238 includes a longitudinal stop member 240, a rotation stop member 242, and a dosing surface 244. As shown in FIG. 35a, the longitudinal stop member 240, the rotation stop member 242, and the dosing surface 244 project proximally from the proximal surface of the housing 208, and the rotation stop member 242 projects further proximally than the longitudinal stop member 240 and the dosing surface 244. Specifically, the height of the rotation stop member 242 is greater than the height of the longitudinal stop member 240, and the height of the longitudinal stop member 240 is greater than the height of the dosing surface 244. In some examples, the dosing surface 244 does not project from the proximal surface of the housing 208. In these examples, the longitudinal stop The plunger stop mechanism 238 is positioned on the proximal surface of the housing 208 adjacent to (e.g., at least partially surrounding) the plunger through-hole 236. The plunger stop mechanism 238 includes a longitudinal stop member 240, a rotation stop member 242, and a dosing surface 244. As shown in FIG. 35a, the longitudinal stop member 240, the rotation stop member 242, and the dosing surface 244 project proximally from the proximal surface of the housing 208, and the rotation stop member 242 projects further proximally than the longitudinal stop member 240 and the dosing surface 244. Specifically, the height of the rotation stop member 242 is greater than the height of the longitudinal stop member 240, and the height of the longitudinal stop member 240 is greater than the height of the dosing surface 244. In some examples, the dosing surface 244 does not project from the proximal surface of the housing 208. In these examples, the longitudinal stop The plunger stop mechanism 238 is positioned on the proximal surface of the housing 208 adjacent to (e.g., at least partially surrounding) the plunger through-hole 236. The plunger stop mechanism 238 includes a longitudinal stop member 240, a rotation stop member 242, and a dosing surface 244. As shown in FIG. 35a, the longitudinal stop member 240, the rotation stop member 242, and the dosing surface 244 project proximally from the proximal surface of the housing 208, and the rotation stop member 242 projects further proximally than the longitudinal stop member 240 and the dosing surface 244. Specifically, the height of the rotation stop member 242 is greater than the height of the longitudinal stop member 240, and the height of the longitudinal stop member 240 is greater than the height of the dosing surface 244. In some examples, the dosing surface 244 does not project from the proximal surface of the housing 208. In these examples, the longitudinal stop The plunger stop mechanism 238 is positioned on the proximal surface of the housing 208 adjacent to (e.g., at least partially surrounding) the plunger through-hole 236. The plunger stop mechanism 238 includes a longitudinal stop member 240, a rotation stop member 242, and a dosing surface 244. As shown in FIG. 35a, the longitudinal stop member 240, the rotation stop member 242, and the dosing surface 244 project proximally from the proximal surface of the housing 208, and the rotation stop member 242 projects further proximally than the longitudinal stop member 240 and the dosing surface 244. Specifically, the height of the rotation stop member 242 is greater than the height of the longitudinal stop member 240, and the height of the longitudinal stop member 240 is greater than the height of the dosing surface 244. In some examples, the dosing surface 244 does not project from the proximal surface of the housing 208. In these examples, the longitudinal stop The plunger stop mechanism 238 is positioned on the proximal surface of the housing 208 adjacent to (e.g., at least partially surrounding) the plunger through-hole 236. The plunger stop mechanism 238 includes a longitudinal stop member 240, a rotation stop member 242, and a dosing surface 244. As shown in FIG. 35a, the longitudinal stop member 240, the rotation stop member 242, and the dosing surface 244 project proximally from the proximal surface of the housing 208, and the rotation stop member 242 projects further proximally than the longitudinal stop member 240 and the dosing surface 244. Specifically, the height of the rotation stop member 242 is greater than the height of the longitudinal stop member 240, and the height of the longitudinal stop member 240 is greater than the height of the dosing surface 244. In some examples, the dosing surface 244 does not project from the proximal surface of the housing 208. In these examples, the longitudinal stop The plunger stop mechanism 238 is positioned on the proximal surface of the housing 208 adjacent to (e.g., at least partially surrounding) the plunger through-hole 236. The plunger stop mechanism 238 includes a longitudinal stop member 240, a rotation stop member 242, and a dosing surface 244. As shown in FIG. 35a, the longitudinal stop member 240, the rotation stop member 242, and the dosing surface 244 project proximally from the proximal surface of the housing 208, and the rotation stop member 242 projects further proximally than the longitudinal stop member 240 and the dosing surface 244. Specifically, the height of the rotation stop member 242 is greater than the height of the longitudinal stop member 240, and the height of the longitudinal stop member 240 is greater than the height of the dosing surface 244. In some examples, the dosing surface 244 does not project from the proximal surface of the housing 208. In these examples, the longitudinal stop The plunger stop mechanism 238 is positioned on the proximal surface of the housing 208 adjacent to (e.g., at least partially surrounding) the plunger through-hole 236. The plunger stop mechanism 238 includes a longitudinal stop member 240, a rotation stop member 242, and a dosing surface 244. As shown in FIG. 35a, the longitudinal stop member 240, the rotation stop member 242, and the dosing surface 244 project proximally from the proximal surface of the housing 208, and the rotation stop member 242 projects further proximally than the longitudinal stop member 240 and the dosing surface 244. Specifically, the height of the rotation stop member 242 is greater than the height of the longitudinal stop member 240, and the height of the longitudinal stop member 240 is greater than the height of the dosing surface 244. In some examples, the dosing surface 244 does not project from the proximal surface of the housing 208. In these examples, the longitudinal stop The plunger stop mechanism 238 is positioned on the proximal surface of the housing 208 adjacent to (e.g., at least partially surrounding) the plunger through-hole 236. The plunger stop mechanism 238 includes a longitudinal stop member 240, a rotation stop member 242, and a dosing surface 244. As shown in FIG. 35a, the longitudinal stop member 240, the rotation stop member 242, and the dosing surface 244 project proximally from the proximal surface of the housing 208, and the rotation stop member 242 projects further proximally than the longitudinal stop member 240 and the dosing surface 244. Specifically, the height of the rotation stop member 242 is greater than the height of the longitudinal stop member 240, and the height of the longitudinal stop member 240 is greater than the height of the dosing surface 244. In some examples, the dosing surface 244 does not project from the proximal surface of the housing 208. In these examples, the longitudinal stop The plunger stop mechanism 238 is positioned on the proximal surface of the housing 208 adjacent to (e.g., at least partially surrounding) the plunger through-hole 236. The plunger stop mechanism 238 includes a longitudinal stop member 240, a rotation stop member 242, and a dosing surface 244. As shown in FIG. 35a, the longitudinal stop member 240, the rotation stop member 242, and the dosing surface 244 project proximally from the proximal surface of the housing 208, and the rotation stop member 242 projects further proximally than the longitudinal stop member 240 and the dosing surface 24 The proximal surface of the housing 208 between the member 240 and the rotation stop member 242 serves as the dosing surface 24 4. In some examples, the plunger stop mechanism 238 is (instead of the two longitudinal stop members 240 and the two rotation stop members 242 as shown in FIG. 35a ) includes only a single longitudinal stop member 240 and a single rotation stop member 242. In some examples the plunger stop mechanism includes three or more longitudinal stop members and three or more rotation stop members and .

[0127] In some examples, the injection device 200 is used to dispense and / or inject an accurate dose of the solution (e.g., a dose in the range of 5 μL to 250 μL of the injection solution) contained within the inner injection solution container 210 . In a first step, the plunger 204 is displaced distally relative to the inner injection solution container 210 (e.g., while the plunger 204 is in a first orientation O1 about the longitudinal axis of the plunger 204) until the plunger 204 reaches a first dosing position P1 along the longitudinal axis of the plunger 204, whereby excess injection solution is expelled from the inner injection solution container 210. As shown in FIG. 36a, when the plunger flange 226 contacts the longitudinal stop member 240 and the rotation stop member 242, the plunger 204 is in the first dosing position P1 and the first orientation O1. Thereafter, a desired dose / amount of the injection solution can be dispensed and / or injected (e.g., into the patient's tissue). As shown in FIG. 36a, the longitudinal stop member 240, at the first dosing position P1, causes the plunger 204 to be distally relative to the injection solution container 202 / inner injection solution container 210 and in the first orientation O1 .

[0128] As shown in FIG. 36a, at the first dosing position P1, the longitudinal stop member 240 causes the plunger 204 to be distally relative to the injection solution container 202 / inner injection solution container 210 and configured to prevent displacement. Specifically, the longitudinal stop member 240 prevents the plunger 204 from displacing distally when contacting / abutting against the plunger flange 226 . Further, the rotational stop member 242 is configured to prevent the plunger 204 from rotating about its longitudinal axis in a counterclockwise direction when the plunger 204 is at the first dosing position P1 and in the first orientation O1. Specifically, the rotational stop member 242 prevents the plunger 204 from rotating in a counterclockwise direction when contacting / abutting against the plunger flange 226 . In some examples, both rotational stop members 242 are positioned on the other side of their adjacent longitudinal stop members 240 (e.g., on the side opposite their positions shown in FIG. 35a) . In these examples, the rotational stop member 242 prevents the plunger 204 from rotating in a clockwise direction when contacting / abutting against the plunger flange 226 . Thus, during use of the injection device 200, the user can displace the plunger 204 distally against the inner injection solution container 210 until the plunger 204 reaches the first dosing position P1 (e.g., until the plunger flange 226 contacts the longitudinal stop member 240) to expel excess injection solution from the inner injection solution container 210

[0129] . When the first dosing position P1 is reached, the longitudinal stop member 240 prevents the plunger 204 from further displacing distally . As a result, the user of the injection device 200 is prevented from expelling too much injection solution from the inner injection solution container 210 . And the residual injection solution contained in the inner injection solution container 210 is when the plunger 204 reaches the second dosing position P2 . ​​​​Until then, by further displacing the plunger 204 in the distal direction, metered dispensing and / or injection can be performed. Specifically, as shown in FIG. 36c, the plunger flange 2 26 (e.g., the bottom surface / distal surface of the plunger flange 226) contacts / abuts the dosing surface 244 and the plunger 204 reaches the second dosing position P2. When the second dosing position P2 is reached, the dosing surface 244 prevents further displacement of the plunger 204 in the distal direction, thus preventing over-dispensing and / or injection of the injection solution.

[0130] However, the user of the injection device 200 can, before displacing the plunger 204 to the second dosing position P2 rotate the plunger 204 manually (e.g., using the actuating button 224) from the first orientation O1 to the second orientation O2 about the longitudinal axis of the plunger 204 in a clockwise direction as shown in FIG. 36b. Specifically, after the plunger flange 226 has rotated in the clockwise direction and again contacts / abuts the rotation stop member 242, the plunger 204 is in the second orientation O2. FIG. 36b shows the plunger 204 rotated 90 degrees clockwise from the first orientation O1 to the second orientation O2, although in some examples the user may rotate the plunger 204 more than or less than 90 degrees (e.g., 110 degrees or 45 degrees) from the first orientation O1 to the second orientation O2. In these examples, the longitudinal stop member 240, the rotation stop member 242, and the dosing surface 244 are shaped to accommodate a greater or lesser rotational movement of the plunger 204 and are positioned on the proximal surface of the housing 208 such that. In this way, the plunger flange ​​For example, the lunge 226 remains in the first orientation O1 and in the second orientation O2. As a result, it comes into contact / abuts against the rotation stop member 242.

[0131] The plunger 204 is rotated in a first orientation O1 (while the plunger 204 is in the first dispensing position P1). When rotated from the first orientation O1 to the second orientation O2, the plunger flange 226 contacts the dispensing surface 244 (and The height difference between the hand direction member 240 / rotation stop member 242 and the dispensing surface 244 allows for a longitudinal Directly above the directional member 240 / recess formed between the rotation stop member 242 and the dispensing surface 244 In other words, the plunger 204 is aligned in the second orientation as shown in FIG. When at O2, the distal / bottom surface of the plunger flange 226 is oriented parallel to the dispensing surface 244. As a result, a user of the injection device 200 can see that the plunger flange 226 is in the position to dispense the medication. The plunger 204 is moved distally to the first dosing position P1 until it contacts / abuts the surface 244. to a second dispensing position P2. 204 and prevents the plunger 204 from the second dosing position P2. 202 / inner injection solution container 210) in the distal direction. Thus, the dose of injection solution to be administered to the patient can be determined in a particularly accurate manner. It is possible.

[0132] Specifically, the distance between the first dosing position P1 and the second dosing position P2 of the plunger 204 is When the plunger 204 is displaced from the first dispensing position P1 to the second dispensing position P2, the inner injection A predetermined percentage (for example, 2.5% to 3.5%) of the total volume of the injection solution contained in the solution container 210 In other words, the distal direction is selected to expel the a longitudinal stop member (e.g., contacting the bottom / far surface of the plunger flange 226) Based on the distance between the upper surface / near surface of 240 and the dosing surface 244, when displacing the plunger 204 from the first dosing position P1 to the second dosing position P2, the desired injection solution dosage to be discharged from the inner injection solution container 210 is set.

[0133] Therefore, by changing the height of the longitudinal stop member 240 (e.g., the distal distance from the upper surface / near surface of the longitudinal stop member 240 to the dosing surface 244), (e.g., when the total volume of the injection solution contained in the inner injection solution container 210 does not change) the metered discharge and / or the amount of the dosage to be injected changes. For example, as shown in FIG. 35c, the height of the longitudinal member 24 0 (e.g., the proximal distance from the near surface / upper surface of the housing 208) (therefore, the height of the rotation stop member) can be increased without changing the dosing surface 244. Thus in this example, by increasing the distal distance between the near surface / upper surface of the longitudinal member 240 and the dosing surface 244, the plunger 204 moves a greater distance along its longitudinal axis and therefore, more injection solution contained in the inner injection solution container 210 is metered out so that a larger proportion of the total volume of the injection solution contained in the inner injection solution container 210 is metered out and / or injected. For example, when the inner injection solution container 21 0 contains 200 μL of injection solution, by increasing the distal distance between the near surface / upper surface of the longitudinal member 240 and the dosing surface 244 such that the plunger 204 meters out 12.5% instead of 2.5% of the total volume of the injection solution, (e.g., 2.5% of 200 μL 0, ​​​​​​is 5 μL, and since 12.5% of 200 μL is 25 μL), the plunger 204 is at the When the plunger 204 is displaced from the first dosing position P1 to the second dosing position P2, the amount of the injection solution discharged from the inner injection solution container 210 by the plunger 204 increases by 20 μL.

[0134] The longitudinal stop member 240 and the rotational stop member 242 can prevent the plunger 204 from being displaced distally when (the plunger 204 is at the first dosing position P1 and in the first orientation O1), and can prevent the plunger 204 from rotating certainly when (the plunger 204 is at the first dosing position P1 and in the first orientation O1 or the second orientation O2). As a result, various benefits are provided regarding accurately metering and discharging and / or injecting a precise micro-dose of the injection solution. For example, due to the longitudinal stop member 240 and the rotational stop member 242, the user of the injection device 200 can easily and comfortably deliver a precise micro-dose of the injection solution. Specifically, the longitudinal member 240 prevents the plunger 204 from slidingly displacing distally beyond the range necessary to prime the injection device, so that the user can quickly and easily prime the injection device 200 without accidentally metering and discharging and / or injecting the injection solution for a desired micro-dose. Further, when the plunger 204 is at the first dosing position P1 and in the first orientation O1, the rotational stop member 242 prevents the user from accidentally rotating the plunger 204 in the counterclockwise direction (or in the clockwise direction in some examples), and then displacing the plunger 204 to the second dosing position P2 (and metering and discharging and / or injecting the injection solution) and when the plunger 204 is at the first dosing position P1 and in the first orientation O1, the rotational stop member 242 prevents the user from accidentally rotating the plunger 204 in the counterclockwise direction (or in the clockwise direction in some examples), and then displacing the plunger 204 to the second dosing position P2 (and metering and discharging and / or injecting the injection solution) ) to prevent this. Thus, the rotational direction member 242 then displaces the plunger 204 to the second injection In order to quantitatively discharge and / or inject the injection solution by displacing it to the position P2, the user of the injection device 200 intentionally rotates the plunger 204 in a single direction (e.g., clockwise or counterclockwise) towards the second orientation O2.

[0135] Therefore, at least for the above reasons, the longitudinal stop member 240 and the rotational stop member 24 2 guide the displacement of the plunger 204 by the user and prevent the user from accidentally quantitatively discharging and / or injecting the injection solution (e.g., accidentally over-discharging / injecting the injection solution excessively and / or at an inappropriate time and / or at an inaccurate location (e.g., inaccurate patient tissue)) to quantitatively discharge / inject the injection solution. This makes the injection device 200 particularly easy to use and thus reduces user errors. For example, Table (1) below includes the results of a simulated usage survey of the injection device 2 00. As shown, the simulated usage survey evaluated various operations for using the injection device 200. Before the evaluation, representative training was provided to ophthalmologists / retinal surgeons (i.e., participants), and after a decay period of 1 - 7 weeks, an evaluation session was conducted. Overall, based on the evaluation, n = 25 / 30 (83%) of the participants successfully performed the first injection without any usage errors, and n = 24 / 30 (80%) of the participants successfully performed the second injection without any usage errors. For a total of 22 out of 26 steps (84.6%), the implementation was successful without any usage errors. Therefore, at least for the above reasons, the injection device 200 is particularly suitable for injecting injection solutions into pediatric patients, for example (e.g., / 30 people (83%) of the participants successfully performed the first injection without any usage errors, and n = 24 / 30 people (80%) of the participants successfully performed the second injection without any usage errors. For a total of 22 out of 26 steps (84.6%), the implementation was successful without any usage errors. Therefore, at least for the above reasons, the injection device 200 is particularly suitable for injecting injection solutions into pediatric patients, for example (e.g., / 30 people (83%) of the participants successfully performed the first injection without any usage errors, and n = 24 / 30 people (80%) of the participants successfully performed the second injection without any usage errors. Therefore, at least for the above reasons, the injection device 200 is particularly suitable for injecting injection solutions into pediatric patients, for example (e.g., , pediatric ophthalmic injection), as pediatric patients usually do not remain still when receiving an injection (due to fear of the injection and / or pain caused by the injection), and in a standard injection device that does not induce displacement of the plunger by the user, incorrect inaccurate injections are more likely to occur.

[0136]

Table 1

[0137] Returning to FIG. 35a, as described above, the housing 208 can be easily and quickly separated from the injection solution container 202 and, in some examples, can be exchanged with another housing. This enables, for example, the housing 2 08 to be quickly exchanged with another housing based on, for example, the metered discharge and / or the amount of injection solution to be injected. For example, the housing 2 08 in FIG. 35a can be exchanged with a housing having a longitudinal stop member with a greater height (for example, the housing 208 in FIG. 35c, etc.). In this way, the injection device 200 can be reused multiple times to accurately meter and / or inject a micro-dose of injection solution even when different amounts of injection solution are desired for each individual use of the injection device 200 (since the housing 208 is a modular component that can be exchanged based on the desired micro-dose). Further, due to the modularity of the housing 208, the user can, for example, (for example, when multiple injections of different amounts of injection solution are required for patient treatment) quickly exchange the housing 208 based on the desired amount of injection solution to be metered and / or injected during patient treatment.

[0138] In some examples, the plunger stop mechanism 238 (specifically, the longitudinal stop member 240 , the rotational stop member 242, and / or the dosing surface 244) is positioned / fixed on the plunger 204 rather than on the proximal surface / upper surface of the housing 208. In these examples, the plunger stop mechanism 238 faces in the distal direction (e.g., toward the housing 208) rather than in the proximal direction . In other words, the longitudinal stop member 240 and the rotational stop member 242 project in the distal direction .

[0139] In some examples, the plunger stop mechanism 238 is positioned / fixed on the distal surface / bottom surface of the actuating button 224 of the plunger 204 such that the longitudinal stop member 240, the rotational stop member 242, and / or the dosing surface 244 project distally from the distal surface / bottom surface of the actuating button 224 toward the housing 208 (and thus are adjacent to and / or surround the plunger rod 228). In some examples, only the longitudinal stop member 240 and the rotational stop member 242 project distally from the distal surface / bottom surface of the actuating button 224. In these examples , the dosing surface 244 is the distal surface / bottom surface of the actuating button 224 .

[0140] In some examples, the plunger stop mechanism 238 is positioned / fixed on the plunger rod 228. In these examples, the plunger stop mechanism 238 has a proximal surface / upper surface that attaches the plunger stop mechanism 238 to the plunger rod 228 from which the longitudinal stop member 240, the rotational stop member 242, and / or the dosing surface 244 project distally . Specifically, the plunger rod 228 intersects through the proximal surface / upper surface and the pla nger stop mechanism 238 is attached to the plunger rod 228. From there, the longitudinal stop member 240, the rotational stop member 242, and / or the dosing surface 244 project distally . Specifically, the plunger rod 228 intersects through the proximal surface / upper surface, and the pla ​​The plunger stop mechanism is permanently (e.g., immovably) attached to the plunger rod 228 at this intersection. In some examples, the plunger stop mechanism 238 replaces the plunger flange 226 of the plunger 204 (thus, the plunger stop mechanism 238 is positioned where the plunger flange 226 is positioned in FIGS. 35a - 36b). In some examples, the plunger stop mechanism 238 is positioned further below the longitudinal axis of the plunger 204 (in the distal direction) on the plunger rod 228. For example, the plunger stop mechanism 238 may be positioned at the midpoint of the plunger rod 228. In some examples, the plunger stop mechanism 238 is positioned further below the longitudinal axis of the plunger 204 (in the distal direction) on the plunger rod 228. For example, the plunger stop mechanism 238 replaces the plunger flange 226 of the plunger 204 (thus, the plunger stop mechanism 238 is positioned where the plunger flange 226 is positioned in FIGS. 35a - 36b). In some examples, the plunger stop mechanism 238 is positioned further below the longitudinal axis of the plunger 204 (in the distal direction) on the plunger rod 228. In some examples, the plunger stop mechanism 238 is positioned further below the longitudinal axis of the plunger 204 (in the distal direction) on the plunger rod 228. For example, the plunger stop mechanism 238 may be positioned at the midpoint of the plunger rod 228. For example, the plunger stop mechanism 238 may be positioned at the midpoint of the plunger rod 228. For example, the plunger stop mechanism 238 may be positioned at the midpoint of the plunger rod 228.

[0141] Note that the various embodiments of the plunger stop mechanism 238 described above (e.g., higher / lower longitudinal stop members 240, different degrees of rotation of the plunger 204 to reach the second orientation O2, and different numbers of longitudinal stop members 240 and / or rotation stop members 242) still apply in the above examples where the plunger stop mechanism 238 is positioned on the plunger 204. Note that the various embodiments of the plunger stop mechanism 238 described above (e.g., higher / lower longitudinal stop members 240, different degrees of rotation of the plunger 204 to reach the second orientation O2, and different numbers of longitudinal stop members 240 and / or rotation stop members 242) still apply in the above examples where the plunger stop mechanism 238 is positioned on the plunger 204. Note that the various embodiments of the plunger stop mechanism 238 described above (e.g., higher / lower longitudinal stop members 240, different degrees of rotation of the plunger 204 to reach the second orientation O2, and different numbers of longitudinal stop members 240 and / or rotation stop members 242) still apply in the above examples where the plunger stop mechanism 238 is positioned on the plunger 204. Note that the various embodiments of the plunger stop mechanism 238 described above (e.g., higher / lower longitudinal stop members 240, different degrees of rotation of the plunger 204 to reach the second orientation O2, and different numbers of longitudinal stop members 240 and / or rotation stop members 242) still apply in the above examples where the plunger stop mechanism 238 is positioned on the plunger 204. Note that the various embodiments of the plunger stop mechanism 238 described above (e.g., higher / lower longitudinal stop members 240, different degrees of rotation of the plunger 204 to reach the second orientation O2, and different numbers of longitudinal stop members 240 and / or rotation stop members 242) still apply in the above examples where the plunger stop mechanism 238 is positioned on the plunger 204.

[0142] When the plunger stop mechanism 238 is positioned on the plunger 204 (e.g., on the distal face / bottom face of the actuating button 224 or on the plunger rod 228), the housing 208 is configured to interact with the components of the plunger stop mechanism 238 in the same manner as the plunger flange 226 interacts with the components of the plunger stop mechanism 238 when the plunger stop mechanism 238 is positioned on the housing 208. For example, the housing 208 interacts with the longitudinal stop member 240 to cause the plunger 204 to reach the first When the plunger stop mechanism 238 is positioned on the plunger 204 (e.g., on the distal face / bottom face of the actuating button 224 or on the plunger rod 228), the housing 208 is configured to interact with the components of the plunger stop mechanism 238 in the same manner as the plunger flange 226 interacts with the components of the plunger stop mechanism 238 when the plunger stop mechanism 238 is positioned on the housing 208. When the plunger stop mechanism 238 is positioned on the plunger 204 (e.g., on the distal face / bottom face of the actuating button 224 or on the plunger rod 228), the housing 208 is configured to interact with the components of the plunger stop mechanism 238 in the same manner as the plunger flange 226 interacts with the components of the plunger stop mechanism 238 when the plunger stop mechanism 238 is positioned on the housing 208. When the plunger stop mechanism 238 is positioned on the plunger 204 (e.g., on the distal face / bottom face of the actuating button 224 or on the plunger rod 228), the housing 208 is configured to interact with the components of the plunger stop mechanism 238 in the same manner as the plunger flange 226 interacts with the components of the plunger stop mechanism 238 when the plunger stop mechanism 238 is positioned on the housing 208. When the plunger stop mechanism 238 is positioned on the plunger 204 (e.g., on the distal face / bottom face of the actuating button 224 or on the plunger rod 228), the housing 208 is configured to interact with the components of the plunger stop mechanism 238 in the same manner as the plunger flange 226 interacts with the components of the plunger stop mechanism 238 when the plunger stop mechanism 238 is positioned on the housing 208. For example, the housing 208 interacts with the longitudinal stop member 240 to cause the plunger 204 to reach the first configured to prevent further distal displacement of the plunger 204 when it is at the dosing position P1 and in the first orientation O1. As another example, the housing 208 interacts with a rotation stop member 242 to prevent the plunger 204 from rotating about its longitudinal axis in a counterclockwise direction (or in some examples, a clockwise direction) when the plunger 204 is at the first dosing position P1 and in the first orientation O1. Specifically, in some examples, at least a portion of the proximal surface / upper surface of the housing 208 surrounding the plunger through-hole 236 projects proximally along the longitudinal axis of the plunger 204 (such that the plunger through-hole 236 can still slidably receive the plunger rod 228) towards the plunger mechanism 238. In these examples, the protruding proximal surface / upper surface of the housing 208 has a height that is at least equal to the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242 (i.e., the surface of the rotation stop member 242 facing distally towards the housing 208). Thus, when the dosing surface 244 contacts / abuts against the protruding proximal surface / upper surface of the housing 208 (at the second dosing position P2), the distal surface of the rotation stop member 242 is either (1) coplanar with the non-protruding portion of the proximal surface / upper surface of the housing 208 in the proximal direction (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is equal to the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) or (2) (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is greater than the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) the housing 208 In some examples, is configured to prevent the plunger 204 from rotating about its longitudinal axis in a counterclockwise direction (or in some examples, a clockwise direction).

[0143] Specifically, in some examples, at least a portion of the proximal surface / upper surface of the housing 208 surrounding the plunger through-hole 236 projects proximally along the longitudinal axis of the plunger 204 (such that the plunger through-hole 236 can still slidably receive the plunger rod 228) towards the plunger mechanism 238. In these examples, the protruding proximal surface / upper surface of the housing 208 has a height that is at least equal to the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242 (i.e., the surface of the rotation stop member 242 facing distally towards the housing 208). Thus, when the dosing surface 244 contacts / abuts against the protruding proximal surface / upper surface of the housing 208 (at the second dosing position P2), the distal surface of the rotation stop member 242 is either (1) coplanar with the non-protruding portion of the proximal surface / upper surface of the housing 208 in the proximal direction (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is equal to the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) or (2) (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is greater than the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) the housing 208 projects proximally towards the plunger mechanism 238. The protruding proximal surface / upper surface of the housing 208 is the distal surface of the dosing surface 244 and the rotation stop member 242 (i.e., the surface of the rotation stop member 242 facing distally towards the housing 208) and has a height that is at least equal to the distal distance therebetween. Thus, when the dosing surface 244 contacts / abuts against the protruding proximal surface / upper surface of the housing 208 (at the second dosing position P2), the distal surface of the rotation stop member 242 is either (1) coplanar with the non-protruding portion of the proximal surface / upper surface of the housing 208 in the proximal direction (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is equal to the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) or (2) (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is greater than the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) the housing 208 is in contact / abutment with the protruding proximal surface / upper surface of the housing 208, the distal surface of the rotation stop member 242 is either (1) coplanar with the non-protruding portion of the proximal surface / upper surface of the housing 208 in the proximal direction (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is equal to the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) or (2) (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is greater than the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) the housing 208 is either (1) coplanar with the non-protruding portion of the proximal surface / upper surface of the housing 208 in the proximal direction (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is equal to the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) or (2) (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is greater than the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) the housing 208 is either (1) coplanar with the non-protruding portion of the proximal surface / upper surface of the housing 208 in the proximal direction (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is equal to the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) or (2) (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is greater than the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) the housing 208 is either (1) coplanar with the non-protruding portion of the proximal surface / upper surface of the housing 208 in the proximal direction (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is equal to the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) or (2) (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is greater than the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) the housing 208 is either (1) coplanar with the non-protruding portion of the proximal surface / upper surface of the housing 208 in the proximal direction (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is equal to the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) or (2) (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is greater than the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) the housing 208 is either (1) coplanar with the non-protruding portion of the proximal surface / upper surface of the housing 208 in the proximal direction (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is equal to the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) or (2) (e.g., when the height of the protruding proximal surface / upper surface of the housing 208 is greater than the distal distance between the dosing surface 244 and the distal surface of the rotation stop member 242) the housing 208 It does not contact the non-projecting part in the proximal direction of the proximal surface / upper surface. Further, the housing 20 The protruding proximal surface / upper surface of 8 has a shape that conforms to the recess formed between the longitudinal member 240 / rotation stop member 242 and the dosing surface 244 and. In some examples, the housing 2 The protruding proximal surface / upper surface of 08 is the same as the plunger flange 226 in FIGS. 35a to 35c has a rectangular shape. In some examples, the protruding proximal surface / upper surface of the housing 208 is long depending on the shape of the recess formed between the hand direction member 240 / rotation stop member 242 and the dosing surface 244 has different shapes (for example, triangular, rhombic, oval, etc.).

[0144] In the above example where the plunger stop mechanism is on the plunger 204, the plunger 204 is for example, (when the plunger stop mechanism 238 is on the proximal surface / upper surface of the housing 208 in the same way as the housing 208 can be replaced) the injection solution to be quantitatively discharged and / or injected can be replaced with another plunger 204 based on the amount. In other words, the plunger 20 4 can be replaced with another plunger 204 having different (for example, higher or lower) longitudinal members 240, rotation stop members 24 2 and / or dosing surfaces 244. Thus, the injection device 200 can accurately quantitatively discharge and / or inject different amounts of injection solution for each individual use of the injection device 200 (even when the plunger 204 is a modular component that can be replaced based on the desired micro-dose) and can be reused multiple times to inject the micro-dose of injection solution accurately. Further, due to the modularity of the plunger 204 (including the plunger stop mechanism 238 ), for example, (for example, different in the treatment of patients ), ​If multiple injections of the injection solution amount are required, the user can quickly replace the plunger 204 based on the desired amount of the injection solution to be metered and / or injected during the treatment of the patient. and / or can quickly replace the plunger 204 based on the desired amount of the injection solution to be injected. This is possible.

[0145] Figures 37a and 37b show flowcharts of the process of metering and discharging a certain amount of solution using a solution metering device according to various embodiments. Process 3700 is implemented, for example, using the injection device 10 or the injection device 200. In process 3700, some blocks are optionally combined, the order of some blocks is optionally changed, and some blocks are optionally omitted. In some examples, additional steps may be implemented in combination with process 3700. In some examples, additional steps may be performed in combination with process 3700.

[0146] In block 3702, a rotatable plunger (e.g., plunger 204) is slidably inserted into the first end of the solution container (e.g., the inner injection solution container 30 or the inner injection solution container 210), where the second end of the solution container (e.g., the male luer taper 48 or the luer taper 216) is configured to discharge the solution contained in the solution container. In some examples, the solution contains, as shown in block 3704, a vascular endothelial growth factor (VEGF) antagonist (e.g., ranibizumab (i.e., Lucentis ))). In TM some examples, the solution contains, as shown in block 3706, a nucleic acid. In some examples, the solution contains Beovu® (brolucizumab). In some examples, the solution contains Eylea® (aflibercept). In some examples, the solution contains Eylea® (aflibercept). In some examples, the solution including Luxturna (registered trademark) (voretigene neparvovec).

[0147] In block 3708, while the rotatable plunger is in a first orientation (e.g., a rotational orientation, an angular position, a rotational attitude with respect to a first axis) (e.g., a first orientation O1), the rotatable plunger is displaced slidably along a first axis until it reaches a first position (e.g., a first dosing position P1) with respect to the solution container.

[0148] In block 3710, a first stop member (e.g., a longitudinal stop member 240) prevents the rotatable plunger from slidingly displacing to a second position (e.g., a second dosing position P2) with respect to the solution container that is closer to a second end of the solution container than the first position while the rotatable plunger is in the first position and the first orientation (e.g., the rotatable plunger is slidably displaceable further into the solution container when in the second position than when in the first position).

[0149] In some examples, as shown in block 3712, the first stop member is positioned on the rotatable plunger. In some examples, the first stop member is positioned on a bottom surface of an actuating button (e.g., actuating button 72 or actuating button 224) positioned at an end of the rotatable plunger that cannot be slidably received by the solution container (e.g., the bottom surface is closer to a first end of the solution container (along the first axis) than an upper surface of the actuating button). In some examples, the first stop member is positioned at a location along a shaft of the rotatable plunger (e.g., a midpoint of the rotatable plunger).

[0150] ​​​​​​​​​​​In some examples, the rotatable plunger is rotatable, as shown in block 3714. While the rotatable plunger is in the first position and in the first orientation, it contacts the first stop member and prevents the rotatable plunger from slidingly displacing to the second position, a flange (e.g., fixed to the rotatable plunger and rotating about the first axis with the rotatable plunger) having a first shape (e.g., rectangular, elliptical, diamond-shaped, etc.) is included (e.g., flange 226). In some examples, the flange is slidably received by the solution container positioned at an end of the rotatable plunger that cannot be slidably received (e.g., directly below the bottom surface of the actuating button of the rotatable plunger). In some examples, the flange is positioned at a location along the shaft of the rotatable plunger (e.g., the midpoint of the shaft of the rotatable plunger).

[0151] In block 3716, the second stop member (e.g., rotation stop member 242) prevents the rotatable plunger from rotating about the first axis in a first direction (e.g., rotating in a first direction (e.g., counterclockwise) to reach a second orientation) while the rotatable plunger is in the first position and in the first orientation.

[0152] In some examples, as shown in block 3718, the second stop member is positioned on the rotatable plunger. In some examples, the second stop member is positioned on the bottom surface of the actuating button positioned at an end of the rotatable plunger that cannot be slidably received by the solution container (e.g., the bottom surface is closer to the first end of the solution container (along the first axis) than the top surface of the actuating button). In some examples, the second stop member is on the shaft of the rotatable plunger. ​​​​​​​​​​​It is positioned at a location along the plunger (e.g., the midpoint of the rotatable plunger).

[0153] In some examples, the rotatable plunger is rotatable as shown in block 3720 while the rotatable plunger is in the first position and in the first direction, it contacts the second stop member and prevents the rotatable plunger from rotating about the first axis, a flange (e.g., a first-shaped flange fixed to the rotatable plunger and rotating about the first axis together with the rotatable plunger (e.g., rectangular, elliptical, diamond-shaped, etc.) having a shape). including a flange).

[0154] In some examples, the solution metering and discharging device is configured to prevent the rotatable plunger from rotating about the first axis until the rotatable plunger is positioned at the first position as shown in block 3722 (e.g., preventing the rotatable plunger from rotating in any direction (e.g., the first or second direction)). In some examples, the solution metering and discharging device is further configured to engage with one or more guiding channels (e.g., guiding channel 227 ) of the rotatable plunger and prevent the rotatable plunger from rotating about the first axis until the rotatable plunger is positioned at the first position. In some examples, the solution container includes a guiding element (e.g., at the first end). In some examples, the housing includes a guiding element (e.g., in the plunger through-hole). one or more guiding elements (e.g., guiding element 92) configured to engage with the rotatable plunger and prevent the rotatable plunger from rotating about the first axis until the rotatable plunger is positioned at the first position. In some examples, the solution container includes a guiding element (e.g., at the first end). In some examples, the housing includes a guiding element (e.g., (e.g., at the first end) includes a guiding element. In some examples, the housing includes a guiding element (e.g., in the plunger through-hole).

[0155] In block 3724, rotate the rotatable plunger in the second direction about the first axis until the rotatable plunger is in the first position and in the second orientation (e.g., the second orientation O2). ​In some examples, a third stop member (e.g., the rotating member 242) is shown in block 3726 such that while the rotatable plunger is in the first position and in the second orientation, the rotatable plunger is prevented from rotating in a second direction about the first axis (e.g., rotating in a second direction (e.g., clockwise) to reach the first orientation).

[0156] In block 3728, while the rotatable plunger is in the second orientation, the rotatable plunger is displaced slidably along the first axis until the rotatable plunger reaches a second position relative to the solution container, whereupon a certain amount (e.g., a fixed volume, a metered volume) of the solution contained within the solution container is dispensed in a metered manner. In some examples, as shown in block 3730, the amount of solution dispensed in a metered manner when the rotatable plunger is displaced slidably from the first position to the second position is selected from the group consisting of 5 μL, 10 μL, and 20 μL.

[0157] In some examples, the solution container holds from 100 μL to 1000 μL of solution. In some examples, the amount of solution dispensed in a metered manner when the rotatable plunger is displaced slidably from the first position to the second position is from 2.5% to 12.5% of the solution contained within the solution container.

[0158] In some examples, the method (e.g., process 3700) is used for pediatric ophthalmic injections, as shown in block 3732. In some examples, the method (e.g., process 37 00) is used for gene therapy, as shown in block 3734.

[0159] In some examples, as shown in block 3736, the solution metering and dispensing device further includes a housing (e.g., a fixed housing that does not rotate about a first axis) (e.g., housing 208) configured to be removably connected to the solution container (e.g., using a releasable clip included in the housing to connect to the solution container), where the housing is configured to slidably receive a rotatable plunger and to enable the solution container to slidably receive the rotatable plunger, and includes a plunger through-hole (e.g., a plunger through-hole or plunger through-hole 236). In some examples, as shown in block 3738, the first stop member is positioned on the housing (e.g., positioned adjacent to the plunger through-hole on the upper surface of the housing, where the upper surface is farther from the first end of the solution container than the bottom surface of the housing). In some examples, as shown in block 3740, the second stop member is positioned on the housing (e.g., positioned adjacent to the plunger through-hole on the upper surface of the housing, where the upper surface is farther from the first end of the solution container than the bottom surface of the housing). In some examples, as shown in block 3742, the first stop member has a first height, and the amount of solution dispensed when the rotatable plunger is slidably displaced from the first position to the second position is at least partially based on the first height. Figures 38a through 38s show additional views of an injection device (e.g., injection device 200) and its components according to various examples. For example, the plunger through-hole or plunger through-hole 236). For example, the upper surface is farther from the first end of the solution container than the bottom surface of the housing).

[0160] In some examples, as shown in block 3738, the first stop member is positioned on the housing (e.g., positioned adjacent to the plunger through-hole on the upper surface of the housing, where the upper surface is farther from the first end of the solution container than the bottom surface of the housing). For example, positioned adjacent to the plunger through-hole on the upper surface of the housing, where the upper surface is farther from the first end of the solution container than the bottom surface of the housing). For example, the upper surface is farther from the first end of the solution container than the bottom surface of the housing).

[0161] In some examples, as shown in block 3740, the second stop member is positioned on the housing (e.g., positioned adjacent to the plunger through-hole on the upper surface of the housing, where the upper surface is farther from the first end of the solution container than the bottom surface of the housing). For example, positioned adjacent to the plunger through-hole on the upper surface of the housing, where the upper surface is farther from the first end of the solution container than the bottom surface of the housing). For example, the upper surface is farther from the first end of the solution container than the bottom surface of the housing).

[0162] In some examples, as shown in block 3742, the first stop member has a first height, and the amount of solution dispensed when the rotatable plunger is slidably displaced from the first position to the second position is at least partially based on the first height. When the rotatable plunger is slidably displaced from the first position to the second position, the amount of solution dispensed is at least partially based on the first height.

[0163] Figures 38a through 38s show additional views of an injection device (e.g., injection device 200) and its components according to various examples. and its components according to various examples.

[0164] An exemplary solution metering and dispensing device and method are described in the following items. 1. A solution metering and dispensing device (200), comprising: A rotatable plunger (204); A solution container (202) having a first end configured to slidably receive the rotatable plunger and a second end configured to meteringly dispense the solution contained within the solution container, wherein the solution metering and dispensing device enables the rotatable plunger to be slidably displaced along a first axis such that when the rotatable plunger is in a first orientation (O1), it is positioned at a first position (P 1) with respect to the solution container, and enables the rotatable plunger to be slidably displaced along the first axis from the first position to a second position (P2) with respect to the solution container when the rotatable plunger is in a second orientation (O2), wherein the second position is closer to the second end of the solution container than the first position, and wherein displacing the rotatable plunger slidably from the first position to the second position causes a quantity of the solution contained within the solution container to be meteringly dispensed; A first stop member (240) configured to prevent the rotatable plunger from being slidably displaced to the second position while the rotatable plunger is in the first position and in the first orientation; A second stop member (24 2) configured to prevent the rotatable plunger from rotating about the first axis in a first direction while the rotatable plunger is in the first position and in the first orientation; and A third stop member (2 42) configured to prevent the rotatable plunger from rotating about the first axis in a second direction while the rotatable plunger is in the first position and in the second orientation. 2. A third stop member (2 42) configured to prevent the rotatable plunger from rotating about the first axis in a second direction while the rotatable plunger is in the first position and in the second orientation. A first stop member (240) configured to prevent the rotatable plunger from being slidably displaced to the second position while the rotatable plunger is in the first position and in the first orientation; And A second stop member (24 2) configured to prevent the rotatable plunger from rotating about the first axis in a first direction while the rotatable plunger is in the first position and in the first orientation; And A solution metering and dispensing device (200) comprising the above. 3. A third stop member (2 42) configured to prevent the rotatable plunger from rotating about the first axis in a second direction while the rotatable plunger is in the first position and in the second orientation. 42 The solution metering and discharging device according to item 1, further comprising 3. The solution metering and discharging device according to item 1 or 2, wherein the first stop member is positioned on the rotatable plunger . 4. The solution metering and discharging device according to any one of items 1 to 3, wherein the second stop member is positioned on the rotatable plunger . 5. A housing (208) configured to be releasably connected to the solution container, the housing including a plunger through hole (23 6) configured to slidably receive the rotatable plunger and to enable the solution container to slidably receive the rotatable plunger , the solution metering and discharging device according to any one of items 1 to 4 . 6. The solution metering and discharging device according to item 5, wherein the first stop member is positioned on the upper surface of the housing, and the first stop member protrudes proximally along the first axis from the upper surface of the housing . 7. The solution metering and discharging device according to item 5 or 6, wherein the second stop member is positioned on the upper surface of the housing, and the second stop member protrudes proximally along the first axis from the upper surface of the housing . 8. The solution metering and discharging device according to any one of items 5 to 7, wherein the first stop member has a first height with respect to the upper surface of the housing, and the amount of solution metered and discharged when the rotatable plunger slidably displaces from the first position to the second position is at least partly based on the first height . 9. The solution metering and discharging device according to item 8, wherein the second stop member has a second height greater than the first height with respect to the upper surface of the housing . 10. The outer surface of the solution container includes a clip receiving element (220), the housing includes a housing clip (234), Any one of items 5 to 9, wherein the housing clip is releasably connected to the clip receiving element The solution metering and discharging device according to any one of the preceding items. 11. The first end of the solution container includes a flange element (214), and the housing is configured to slidably receive the flange element when the clip is releasably connected to the clip receiving element. The solution metering and discharging device according to item 10. 12. The rotatable plunger includes a flange (226), and the flange contacts the first stop member to prevent the rotatable plunger from slidingly displacing to the second position while the rotatable plunger is in the first position and in the first orientation. The flange contacts the second stop member to prevent the rotatable plunger from rotating about the first axis in the first direction while the rotatable plunger is in the first position and in the first orientation. The solution metering and discharging device according to any one of items 1 to 11. 13. The solution metering and discharging device according to any one of items 1 to 12, wherein the rotatable plunger is configured to be prevented from rotating about the first axis until it is positioned at the first position. 14. The amount of the solution to be metered and discharged when the rotatable plunger slidably displaces from the first position to the second position is selected from the group consisting of 5 μL, 10 μL, and 20 μL. The solution metering and discharging device according to any one of items 1 to 13. 15. The inner surface of the solution container (210) is coated with a plasma enhanced chemical vapor deposition (PECVD) coating, and the PECVD coating provides a smooth lubricating layer on the inner surface. The solution metering and discharging device according to any one of items 1 to 14. 16. The inner surface of the solution container is coated with octamethylcyclotetrasiloxane (OMCTS) as a precursor. 17. The solution metering and discharging device according to any one of items 1 to 15. 18. The solution metering and discharging device according to any one of items 1 to 16, wherein the solution container is made of a material selected from the group consisting of polypropylene, polyethylene, and cyclic olefin copolymer. 19. The solution metering and discharging device according to any one of items 1 to 17, wherein the solution container has a wall thickness of 0.1 mm to 1 mm. 20. The solution metering and discharging device according to any one of items 1 to 18, wherein the solution container has a volume of 10 μL to 100 μL. 21. The solution metering and discharging device according to any one of items 1 to 19, wherein the solution container has a height of 5 mm to 20 mm. 22. The solution metering and discharging device according to any one of items 1 to 20, wherein the solution container has a diameter of 3 mm to 10 mm. 23. The solution metering and discharging device according to any one of items 1 to 21, wherein the housing has a length of 20 mm to 50 mm. 24. The solution metering and discharging device according to any one of items 1 to 22, wherein the housing has a width of 10 mm to 30 mm. 25. The solution metering and discharging device according to any one of items 1 to 23, wherein the housing has a height of 5 mm to 20 mm. Lubricant-coated by a PECVD process using S), and the solution metering and discharging device according to any one of items 1 to 15. The solution metering and discharging device according to any one of items 1 to 15, which is coated with a lubricant coating created from a PECVD process. 17. The solution container is made of silicon, carbon, and oxygen under at least ISO class 8 conditions during operation and ISO class 7 conditions during rest according to ISO 14644, and is manufactured by a PECVD process using high-frequency power. The solution metering and discharging device according to any one of items 1 to 16. The solution metering and discharging device according to any one of items 1 to 16, which is manufactured by a PECVD process using high-frequency power of silicon, carbon, and oxygen under at least ISO class 8 conditions during operation and ISO class 7 conditions during rest according to ISO 14644. The solution metering and discharging device according to any one of items 1 to 16, which is manufactured by a PECVD process using high-frequency power of silicon, carbon, and oxygen under at least ISO class 8 conditions during operation and ISO class 7 conditions during rest according to ISO 14644. The solution metering and discharging device according to any one of items 1 to 16, which is manufactured by a PECVD process using high-frequency power of silicon, carbon, and oxygen under at least ISO class 8 conditions during operation and ISO class 7 conditions during rest according to ISO 14644. 18. A method for metering and discharging a solution from a solution metering and discharging device (200), the solution metering and discharging device having a rotatable plunger (204), a solution container (202), a first stop member (240), and a second stop member (242). The step of slidably inserting the rotatable plunger into the first end of the solution container, wherein the second end of the solution container is configured to meter and discharge the solution contained in the solution container. The step of slidably inserting the rotatable plunger into the first end of the solution container, wherein the second end of the solution container is configured to meter and discharge the solution contained in the solution container. The step of slidably displacing the rotatable plunger along the first axis until the rotatable plunger reaches the first position (P1) relative to the solution container while the rotatable plunger is in the first orientation (O1). The step of slidably displacing the rotatable plunger along the first axis until the rotatable plunger reaches the first position (P1) relative to the solution container while the rotatable plunger is in the first orientation (O1). The step of slidably displacing the rotatable plunger along the first axis until the rotatable plunger reaches the first position (P1) relative to the solution container while the rotatable plunger is in the first orientation (O1). The step of slidably displacing the rotatable plunger along the first axis until the rotatable plunger reaches the first position (P1) relative to the solution container while the rotatable plunger is in the first orientation (O1). The step of slidably displacing the rotatable plunger along the first axis until the rotatable plunger reaches the first position (P1) relative to the solution container while the rotatable plunger is in the first orientation (O1). The step of slidably displacing the rotatable plunger along the first axis until the rotatable plunger reaches the first position (P1) relative to the solution container while the rotatable plunger is in the first orientation (O1). The step of preventing the rotatable plunger from slidably displacing to a second position (P2) closer to the second end of the solution container than the first position relative to the solution container while the rotatable plunger is in the first position and the first orientation, and the first stop member. The step of preventing the rotatable plunger from slidably displacing to a second position (P2) closer to the second end of the solution container than the first position relative to the solution container while the rotatable plunger is in the first position and the first orientation, and the first stop member. The step of preventing the rotatable plunger from slidably displacing to a second position (P2) closer to the second end of the solution container than the first position relative to the solution container while the rotatable plunger is in the first position and the first orientation, and the first stop member. The step of preventing the rotatable plunger from rotating in the first direction about the first axis while the rotatable plunger is in the first position and the first orientation, and the second stop member. The step of preventing the rotatable plunger from rotating in the first direction about the first axis while the rotatable plunger is in the first position and the first orientation, and the second stop member. The step of rotating the rotatable plunger until the rotatable plunger reaches the second orientation (O2) at the first position. , a step of rotating in a second direction about a first axis; While the rotatable plunger is in the second position, the rotatable plunger is moved to a second position relative to the solution container until the rotatable plunger reaches the second position, a step of displacing the rotatable plunger slidably along the first axis wherein by slidably displacing the rotatable plunger from the first position to the second position, a certain amount of the solution contained in the solution container is quantitatively discharged; 19. The method according to item 18, wherein the third stop member (242) prevents the rotatable plunger from rotating in the second direction about the first axis while the rotatable plunger is in the first position and facing in the second direction. 20. The method according to item 18 or 19, wherein the first stop member is positioned on the rotatable plunger. 21. The method according to any one of items 18 to 20, wherein the second stop member is positioned on the rotatable plunger. 22. The solution metering device further includes a housing (208) configured to be releasably connected to the solution container, the housing being configured to slidably receive the rotatable plunger and to enable the solution container to slidably receive the rotatable plunger, the method according to any one of items 18 to 21, including a plunger through hole (236). 23. The method according to item 22, wherein the first stop member is positioned on the housing. 24. The method according to item 22 or 23, wherein the second stop member is positioned on the housing. 25. The first stop member has a first height, and the amount of the solution quantitatively discharged when the rotatable plunger is slidably displaced from the first position to the second position is at least partially based on the first height. ​​​​​​​​​, the method according to any one of items 22 to 24. 26. The rotatable plunger includes a flange (226), while the rotatable plunger is in the first position and in the first orientation, the flange contacts the first stop member and prevents the rotatable plunger from slidingly displacing to the second position, while the rotatable plunger is in the first position and in the first orientation, the flange contacts the second stop member and prevents the rotatable plunger from rotating about the first axis in the first direction , the method according to any one of items 18 to 25. 27. The solution metering and discharging device is configured to prevent the rotatable plunger from rotating about the first axis until the rotatable plunger is positioned in the first position, item 18 ~ the method according to any one of 26. ~ the method according to any one of 26. 28. When the rotatable plunger slides from the first position to the second position, the amount of the solution to be metered and discharged is selected from the group consisting of 5 μL, 10 μL, and 20 μL, the method according to any one of items 18 to 27. 29. The solution container contains 100 μL to 1000 μL of the solution, the method according to any one of items 18 to 28 . 30. When the rotatable plunger slides from the first position to the second position, the amount of the solution to be metered and discharged is 2.5% to 12.5% of the solution contained in the solution container, the method according to any one of items 18 to 29. 31. The solution contains a vascular endothelial growth factor (VEGF) antagonist, the method according to any one of items 18 to 30 . 32. The solution contains Beovu (registered trademark) (brolucizumab), the method according to any one of items 18 to 31 . 33. The solution contains Eylea (registered trademark) (aflibercept), the method according to any one of items 18 to 32 The method according to any one of the preceding items. 34. The method according to any one of items 18 to 33, wherein the solution contains Luxturna (registered trademark) (voretigene neparvovec). The method according to any one of items 18 to 33. 35. The method according to any one of items 18 to 34, wherein the solution contains nucleic acid. 36. The method according to any one of items 18 to 35, which is used for pediatric ophthalmic injection. 37. The method according to any one of items 18 to 36, which is used for gene therapy.

Claims

1. A solution dispensing device, comprising: a rotatable plunger; a solution container having a first end configured to slidably receive the rotatable plunger and a second end configured to dispense a solution contained within the solution container, the solution dispensing device comprising: allowing the rotatable plunger to be slidably displaced along a first axis while in a first orientation to be positioned at a first position relative to the solution container; allowing the rotatable plunger to be slidably displaced along the first axis from the first position to a second position relative to the solution container while in a second orientation; It is configured as follows: the second position is closer to the second end of the solution container than the first position; a solution container, wherein slidable displacement of the rotatable plunger distally from the first position to the second position dispensing a quantity of the solution contained within the solution container; a housing configured to be releasably connected to the solution container, the housing including a plunger through-bore configured to slidably receive the rotatable plunger and to allow the solution container to slidably receive the rotatable plunger; a first stop member configured to prevent slidable displacement of the rotatable plunger to the second position while the rotatable plunger is in the first position and in the first orientation, the first stop member projects proximally from a top surface of the housing along the first axis and away from the second end; a first stop member, the first stop member having a first height relative to the top surface of the housing; a second stop member configured to prevent the rotatable plunger from rotating in a first direction about the first axis while the rotatable plunger is in the first position and in the first orientation; the second stop member projects proximally from a top surface of the housing along the first axis and away from the second end; a second stop member having a second height relative to the top surface of the housing that is greater than the first height; A solution dispensing device comprising:

2. a third stop member configured to prevent the rotatable plunger from rotating in a second direction about the first axis while the rotatable plunger is in the first position and in the second orientation; The solution dispensing device of claim 1 further comprising:

3. 3. The solution dispensing device of claim 1, wherein the amount of solution dispensed when the first stop member causes the rotatable plunger to be slidably displaced from the first position to the second position is based at least in part on the first height.

4. an exterior surface of the solution container including a clip-receiving element; the housing includes a housing clip; The solution dispensing device according to any one of claims 1 to 3, wherein the housing clip is releasably connected to the clip receiving element.

5. 5. The solution dispensing device of claim 4, wherein the first end of the solution container includes a flange element, and the housing is configured to slidably receive the flange element when the housing clip is releasably connected to the clip receiving element.

6. the rotatable plunger includes a flange; the flange contacts the first stop member to prevent the rotatable plunger from slidably displacing to the second position while the rotatable plunger is in the first position and in the first orientation; 6. A solution dispensing device according to claim 1, wherein the flange contacts the second stop member to prevent the rotatable plunger from rotating about the first axis in the first direction while the rotatable plunger is in the first position and in the first orientation.

7. 7. A solution dispensing device according to claim 1, configured to prevent the rotatable plunger from rotating about the first axis until the rotatable plunger is positioned at the first position.

8. 8. A solution dispensing device according to any one of claims 1 to 7, wherein the amount of solution dispensed when the rotatable plunger is slidably displaced from the first position to the second position is selected from the group consisting of 5 μL, 10 μL and 20 μL.

9. 9. A solution dispensing device according to any one of claims 1 to 8, wherein the inner surface of the solution container is coated with a plasma enhanced chemical vapor deposition (PECVD) coating, the PECVD coating providing a smooth lubricious layer on the inner surface.

10. 10. The solution dispensing device of any one of claims 1 to 9, wherein the inner surface of the solution container is coated with a lubricant coating made from a PECVD process using octamethylcyclotetrasiloxane (OMCTS) as a precursor.

11. 11. The solution dispensing device of any one of claims 1 to 10, wherein the solution container is manufactured in accordance with ISO 14644 by a PECVD process using radio frequency power consisting of silicon, carbon and oxygen under at least ISO class 8 conditions during operation and ISO class 7 conditions at rest.

12. 1. A method of dispensing a solution from a solution dispensing device, the solution dispensing device having a rotatable plunger, a solution container, a housing, a first stop member, and a second stop member, the method comprising: slidably inserting the rotatable plunger into a first end of the solution container, the second end of the solution container being configured to dispense a solution contained within the solution container; While the rotatable plunger is in a first orientation, slidably displacing the rotatable plunger along a first axis until the rotatable plunger is in a first position relative to the solution container; the housing is configured to be releasably connected to the solution container and includes a plunger through-hole configured to slidably receive the rotatable plunger and to allow the solution container to slidably receive the rotatable plunger; a first stop member that prevents the rotatable plunger from slidably displacing relative to the solution container to a second position closer to the second end of the solution container than the first position while the rotatable plunger is in the first position and the first orientation; the first stop member projects proximally from a top surface of the housing along the first axis and away from the second end; the first stop member has a first height relative to the top surface of the housing; the second stop member prevents the rotatable plunger from rotating in a first direction about the first axis while the rotatable plunger is in the first position and in the first orientation; the second stop member projects proximally from a top surface of the housing along the first axis and away from the second end; a step, the second stop member having a second height relative to the top surface of the housing that is greater than the first height; rotating the rotatable plunger in a second direction about the first axis until the rotatable plunger is in a second orientation at the first position; while the rotatable plunger is in the second orientation, slidably displacing the rotatable plunger along the first axis until the rotatable plunger is in the second position relative to the solution container, wherein slidably displacing the rotatable plunger distally from the first position to the second position dispenses a quantity of the solution contained within the solution container; A method comprising:

13. 13. The method of claim 12, wherein a third stop member prevents the rotatable plunger from rotating in a second direction about the first axis while the rotatable plunger is in the first position and in the second orientation.

14. 14. The method of claim 12 or 13, wherein the amount of the solution dispensed when the rotatable plunger is slidably displaced from the first position to the second position is based at least in part on the first height.

15. the rotatable plunger includes a flange; the flange contacts the first stop member while the rotatable plunger is in the first position and in the first orientation to prevent the rotatable plunger from slidably displacing to the second position; 15. The method of any one of claims 12 to 14, wherein the flange contacts the second stop member while the rotatable plunger is in the first position and first orientation to prevent the rotatable plunger from rotating about the first axis in the first direction.

16. 16. The method of any one of claims 12 to 15, wherein the solution dispensing device is configured to prevent the rotatable plunger from rotating about the first axis until the rotatable plunger is positioned at the first position.

17. 17. The method of any one of claims 12 to 16, wherein the amount of solution dispensed when the rotatable plunger is slidably displaced from the first position to the second position is selected from the group consisting of 5 μL, 10 μL, and 20 μL.

18. The method of any one of claims 12 to 17, wherein the solution container contains between 100 μL and 1000 μL of solution.

19. 19. The method of any one of claims 12 to 18, wherein the amount of solution dispensed when the rotatable plunger is slidably displaced from the first position to the second position is between 2.5% and 12.5% ​​of the solution contained in the solution container.

20. The method of any one of claims 12 to 19, wherein the solution comprises a vascular endothelial growth factor (VEGF) antagonist.

21. 21. The method of any one of claims 12 to 20, wherein the solution comprises Beovu® (brolucizumab).

22. 22. The method of any one of claims 12 to 21, wherein the solution comprises Eylea® (aflibercept).

23. 23. The method of any one of claims 12 to 22, wherein the solution comprises Luxturna® (boretigene neparvovec).

24. The method of any one of claims 12 to 23, wherein the solution comprises nucleic acids.

25. The method according to any one of claims 12 to 24, for use in pediatric ophthalmic injections.

26. The method according to any one of claims 12 to 25, which is used in gene therapy.