Container Adapter and Delivery Assembly

Abstract

A container adapter (1) for a medical delivery device, the medical delivery device having a container seat for holding a container in place, a dosing chamber, a dosing mechanism for transferring liquid from a container held in the container seat to the dosing chamber, and a locking mechanism adapted to prevent operation of the dosing mechanism when the container is not held in the container seat and to allow operation of the dosing mechanism when the container is held in the container seat. The container adapter (1) includes an adapter container seat (11), a connecting structure (12), and a locking mechanism. The adapter container seat (11) is configured to hold the container in place. The connecting structure (12) is removably disposed within the container seat of the medical delivery device and is configured to connect the adapter container seat (11) to the dosing mechanism of the medical delivery device (3) when the connecting structure (12) is disposed within the container seat of the medical delivery device (3). The unlocking mechanism is configured to activate the locking mechanism of the medical delivery device when the joining structure (12) is disposed within the container seat of the medical delivery device and the container is properly held within the adapter container seat (11), and to prevent activation of the locking mechanism of the medical delivery device when the container is not properly held within the adapter container seat (11).

Description

[Technical Field]

[0001] The present invention relates to a container adapter according to the preamble of independent claim 1, and more particularly to a medical delivery device and a delivery assembly comprising such an adapter.

[0002] Such container adapters typically have an adapter seat configured to hold the container in place and a mating structure configured to be removably disposed on the container seat of the medical delivery device and to connect the adapter seat to a dosing mechanism of the medical delivery device when the mating structure is disposed on the container seat of the medical delivery device. They can be used to deliver a definable dose of a liquid stored in the container, such as a drug or drug substance stored in a vial. For example, such delivery can be by injection. [Background technology]

[0003]

[0003] The delivery of liquids or other fluids from a container is required in many medical applications and is accomplished in several different ways. Specific devices are commonly used, particularly when it is essential that the liquid be delivered relatively precisely. For example, liquid medicines or drug substances are often provided in glass or plastic vials closed by a septum or rubber plug and a cap or other similar sealing cover clamped therearound.

[0004] Conventionally, a syringe is used to deliver a pharmaceutical substance from a vial. A transfer needle attached to the syringe penetrates a septum or cover, and the pharmaceutical substance is drawn into the syringe through the transfer needle. Once transferred to the syringe, the pharmaceutical substance is delivered in an appropriate manner. For example, the substance can be injected, for example, subcutaneously or intramuscularly, through a syringe needle, or can be orally applied, for example, to the patient's eyes or nose, or can be provided as liquid drops.

[0005] However, delivering liquid from a vial or container using a syringe is typically relatively difficult and typically requires the involvement of an educated person, such as a doctor or nurse. Patients typically cannot perform the delivery themselves when using a syringe or similar device, especially when the dosage of the delivered liquid must be relatively precise, e.g., when small volumes, such as in the range of 10 microliters to about 1 milliliter, are involved.

[0006] Devices exist that allow for particularly convenient and easy administration, enabling accurate delivery of pharmaceutical substances or drug substances into containers or vials. For example, International Publication No. 2017 / 102760 discloses a medical delivery device having a vial seat for holding a vial in place, a dosing chamber, and a dosing mechanism for transferring a liquid substance from the vial to the dosing chamber. For safety reasons, a locking mechanism is provided that prevents operation of the dosing mechanism when a vial is not held in the vial seat and allows operation of the dosing mechanism when a vial is held in the vial seat. In use, a vial containing the drug substance to be administered is placed in the vial seat. This pierces the cap of the vial to access the interior of the vial. The locking mechanism is then activated to free the medical delivery device for administration. By rotating a dial unit of the medical delivery device relative to the body of the medical delivery device, the drug substance is removed from the vial into the dosing chamber in a controlled and well-defined manner. Once the appropriate amount has been administered, the dial unit is retracted from the body portion together with the vial and the active pharmaceutical ingredient is delivered from the dosing chamber, for example by injection.

[0007] However, a problem that arises in many pharmaceutical applications is that drug substances are not stable enough to be stored for an appropriate period of time. Alternatively, they may require relatively tedious handling or storage to remain intact before administration. Furthermore, the specific composition of a drug substance may vary depending on the application to one patient or another. Therefore, some drug substances are provided in multiple components that must be mixed before administration. For example, it is known to provide drug substance components in multiple vials. Before administration, the components are mixed, for example, by transferring the components from one vial to another vial using a syringe. This usually makes it difficult to maintain hygiene or aseptic standards and ensure accurate handling.

[0008] Furthermore, in some applications, it may be desirable to combine the contents of different vials to prepare an appropriate dose. In particular, vials of drug substance with different fill volumes may be combined to achieve a specific dose. This allows the drug substance to be provided in a smaller volume, so that drug substance waste can be reduced. This can be beneficial, especially when a relatively expensive drug substance is involved.

[0009] To address these issues, WO 2019 / 086589 proposes a container or vial adapter used as an intermediate carrier for attaching a container or vial to a medical delivery device. Specifically, for use with a vial, the vial adapter includes an adapter seat configured to hold the vial in place and a mating structure configured to be removably positioned within the medical delivery device seat and connect the adapter seat to a dosing mechanism of the medical delivery device. The detachable nature of the vial adapter allows multiple vials to be sequentially connected to the medical delivery device. In this manner, substances from multiple vials can be combined prior to administration. For example, a first liquid drug substance can be removed from a first vial placed within the first vial adapter. Once the correct amount of the first drug substance is in the dosing chamber of the medical delivery device, the first vial adapter is removed from the medical delivery device. A second vial adapter holding a second vial containing a second or the same first liquid drug substance is then placed within the medical delivery device seat. The second drug substance is then removed from the second vial and transferred to a dosing chamber of the medical delivery device, whereby the drug substances of the first and second vials are combined within the dosing chamber of the medical delivery device.

[0010] While such container adapters are suitable for addressing the problems described above in connection with known medical delivery devices, problems can arise from the fact that, when the container adapter is placed in the container seat of the medical delivery device, the medical delivery device is in an unlocked state that allows the medical delivery device to be operated to dispense a quantity of substance into the dispensing chamber. If the purpose of providing a locking mechanism on the medical delivery device is to ensure that dispensing, i.e., withdrawal of liquid into the dispensing chamber, is possible only when a container or vial is placed in the container seat of the medical delivery device, this security measure becomes inoperative when the container adapter is used. More specifically, since the container adapter itself activates the unlocking mechanism so that the medical delivery device is in an unlocked state when the adapter is placed in the container seat, it is not possible to ensure that the container adapter is the only container or vial connected to the medical delivery device. Therefore, it may happen that a container is not placed in the container adapter when the container adapter is placed in the container seat of the medical delivery device. Or, the container may not be properly held in the container adapter, such that its interior cannot be accessed as intended. Such an incorrect configuration can result in impaired dispensing via the medical delivery device.

[0011] Therefore, there is a need for a system that can increase the operational safety of a medical delivery device and ensure the dosing accuracy of the medical delivery device when using a container adapter. Summary of the Invention

[0012] According to the present invention, this need is solved by a container adapter as defined by the features of independent claim 1 and by a delivery assembly as defined by the features of independent claim 12. Preferred embodiments are the subject of the dependent claims.

[0013] In one aspect, the present invention is a container adapter for a medical delivery device. The medical delivery device may be, in particular, a device for administering a liquid substance. For example, it may be a drug delivery device for applying a liquid drug or drug substance. Using such a delivery device, the liquid substance or drug substance can be delivered or administered in a suitable form by ophthalmic drops, oral administration, etc. In particular, the medical delivery device may be an injection device for subcutaneously or intramuscularly injecting the drug substance.

[0014] Medical delivery devices typically have a delivery orifice that can be shaped for a particular application or administration of the substance or agent to be delivered. For example, if the medical delivery device is for injecting an agent, the delivery orifice may be a needle. In such embodiments, the delivery orifice or needle may extend from the interior of the housing through a proximal opening thereof and from the housing or a particular portion thereof. The delivery orifice may also be adapted to be connected to a delivery member. For example, it may include a male or female portion of a Luer lock or Luer taper connector, and the delivery member may be equipped with a corresponding female or male Luer lock connector. Other examples of delivery orifices are nozzles, valves, fluid guides, etc.

[0015] In particular, a medical delivery device associated with a container adapter according to the present invention may be a medical delivery device such as that described in WO 2017 / 102760. Such a medical delivery device specifically comprises a container seat for holding a container in place, a dosing chamber, a dosing mechanism for transferring liquid from a container held in the container seat to the dosing chamber, and a locking mechanism adapted to prevent operation of the dosing mechanism when the container is not held in the container seat and to allow operation of the dosing mechanism when the container is held in the container seat.

[0016] The container adapter has an adapter container seat, a mating structure, and an unlocking mechanism. The adapter container seat is configured to hold the container in place. The mating structure is removably disposed within the container seat of the medical delivery device and configured to connect the adapter container seat to a dosing mechanism of the medical delivery device when the mating structure is disposed within the container seat of the medical delivery device. The unlocking mechanism is configured to activate a locking mechanism of the medical delivery device when the mating structure is disposed within the container seat of the medical delivery device and the container is properly held within the adapter container seat. Furthermore, the unlocking mechanism is configured to prevent activation of the locking mechanism of the medical delivery device when the container is not properly held within the adapter container seat.

[0017] The term "container" as used herein may refer to any liquid reservoir suitable for storing and transporting liquids, other fluids, lyophilized substances, or powders, such as capsules. When the liquid, fluid, or powder is a drug substance or a component thereof, the container may specifically be a vial. The term "vial" as used in this context may refer to a relatively small container or bottle commonly used to store pharmaceutical substances, medicines, or drugs in liquid, powder, or encapsulated form. Vials can be made of glass or plastic, e.g., sterilizable materials such as polypropylene. A container can also contain multiple subcontainers, such as multiple vials. The term "predetermined position" in this context may be such that the opening of the container is oriented toward the delivery orifice. Such a container seat allows the container to be connected in a sufficiently predetermined position and orientation, thereby enabling the container to be efficiently coupled to a system or medical delivery device.

[0018] The term "drug" as used herein relates to therapeutically active agents, also commonly referred to as active pharmaceutical ingredients (APIs), as well as combinations of multiple such therapeutically active substances. The term also encompasses diagnostic or imaging agents that must be administered to a patient in liquid form, such as contrast agents (e.g., MRI contrast agents), tracers (e.g., PET tracers), and hormones.

[0019] The terms "drug substance," "drug substance," or "medicine" as used herein relate to a drug as defined above that has been formulated or reconstituted in a form suitable for administration to a patient. For example, in addition to the drug, the drug substance may further comprise excipients and / or other auxiliary ingredients. Particularly preferred drug substances in the context of the present invention are pharmaceutical solutions, in particular solutions for oral administration, injection, or infusion.

[0020] The term "drug product" as used herein or in the like refers to a finished product containing a drug substance or multiple drug substances. In particular, a drug product may be a ready-to-use product having a drug substance in an appropriate dosage and / or in an appropriate form for administration. For example, a drug product may include an administration device such as a pre-filled syringe.

[0021] The mating structure is suitably positioned to be removably positionable within the container seat of the medical delivery device, thereby having a shape or configuration that matches the configuration of the container seat of the medical delivery device. Thus, the mating structure of the container adapter is positioned to be retained by the container seat of the medical delivery device with which it is intended to be used but is not permanently secured. For example, the mating structure can have a portion shaped to correspond to a portion of the container to which the medical delivery device is adapted.

[0022] The adapter container seat can be embodied similarly or essentially identically to the container seat of the medical delivery device. As such, it can receive and hold the container in the same specific manner as the medical delivery device. As one skilled in the art will recognize, container seats of medical delivery devices can be configured in many ways to hold the container in place. In particular, they are typically tailored to the shape or design of the particular container with which they are used. For example, the container seat can be configured with a snap mechanism, e.g., having flexible arms and / or protrusions, for gripping the neck of the container, a clamping mechanism for clamping the body of the container, a sleeve for receiving and guiding the container, etc.

[0023] The term "properly held" in reference to a container and adapter seat refers to a container positioning that allows intended access to the container's interior, such that the container can be placed in a particular position and / or orientation within the adapter seat. If the container is only partially placed within the seat or is not pressed / moved on the seat to a sufficient degree, the container will not be properly held. The term "not properly held" in this context also encompasses situations in which the container is not placed or held in the adapter seat at all.

[0024] The term "activating the locking mechanism" in relation to the unlocking mechanism relates to adapting the medical delivery device to allow a dispensing operation of the medical delivery device that would normally be prevented or impossible without activating the locking mechanism, but after activation the medical delivery device is in a dispensing position. Activating the locking mechanism thereby can include changing the medical delivery device from a locked state in which dispensing is prevented or locked to a dispensing state in which dispensing is possible.

[0025] By including a locking release mechanism, the container adapter according to the present invention can ensure that the locking mechanism of the medical delivery device functions properly even when the container adapter is used instead of seating the container directly within the medical delivery device. More specifically, the locking release mechanism can ensure that the locking mechanism of the medical delivery device is activated only when the container is properly held within the adapter container seat. Activation of the locking mechanism can thereby cause the medical delivery device to change from a locked state to a dispensing state. In this dispensing state, the medical delivery device can be operated, i.e., a substance can be transferred from a container in the container adapter to a dispensing chamber of the medical delivery device. If a container is not placed within the adapter container seat or if the container is not properly held within the adapter container seat, the locking mechanism of the medical delivery device will not activate. Thus, the medical delivery device can remain in a locked state in which dispensing is not possible.

[0026] Thus, compared to known container adapters of this type, the container adapter according to the invention makes it possible to increase the operational safety of the medical delivery device and to ensure the dosing accuracy of the medical delivery device.

[0027] Preferably, the unlocking mechanism includes an actuating member movable relative to the adapter container seat from an inactivated position, in which the locking mechanism of the medical delivery device is not activated when the mating structure is disposed within the container seat of the medical delivery device, to an activated position, in which the locking mechanism of the medical delivery device is activated when the mating structure is disposed within the container seat of the medical delivery device. The actuating member may be a multi-component unit, or more specifically, a single-component unit. Because the adapter container seat is typically located at a location different from where activation of the locking mechanism must be initiated, recognition that the container is properly held within the adapted container seat must be transmitted to the location where the locking mechanism should be activated. Such transmission can be efficiently achieved by moving the actuating member. In a reliable and relatively simple embodiment, the movement of the actuating member can be quasi-linear, particularly along the longitudinal axis of the medical delivery device or the axis of the container adapter.

[0028] Thereby, the actuating member of the unlocking mechanism is preferably arranged to be moved from the inactive position to the active position by the container while the container is seated in the adapter seat. Such simultaneous movement of the actuating member and seating of the container in the adapter seat can ensure that the actuating member is in the active position once the container is properly seated or positioned. Thereby, the term "seated in the adapter seat" can relate to the period during which the container is placed in the adapter seat.

[0029] The actuating member of the unlocking mechanism preferably has a container surface, and the unlocking mechanism is configured such that the container contacts the container surface to move the actuating member while the container is being placed in the adapter container seat. Such a container surface can enable positive movement of the actuating member while the container is being placed in the adapter container seat.

[0030] Preferably, the actuating member of the unlocking mechanism has a locking mechanism surface configured to contact a pushing portion of the locking mechanism of the medical delivery device when the container is held in the adapter container seat and while the joining structure is disposed in the container seat of the medical delivery device to actuate the locking mechanism of the medical delivery device. In particular, the pushing portion of the locking mechanism can be axially displaced while the container adapter is attached to the medical delivery device when the container is held in the adapter container seat. Such a locking mechanism surface allows for efficient movement of the locking mechanism of the medical delivery device via the pushing portion.

[0031] The actuating member of the unlocking mechanism preferably has a stem portion extending from the adapter container seat to the mating structure. The stem portion can form an efficient transmission for initiating actuation of the locking mechanism of the delivery device when the container is held within the adapter container seat. The stem portion can extend along the longitudinal axis of the medical device or system, which can be essentially linear or define an essentially linear axis itself.

[0032] Thus, the container surface is preferably located at one longitudinal end of the stem portion and the locking mechanism surface is located at the other longitudinal end of the stem portion, thereby enabling the stem portion to reliably contact the actuating member with the container and the locking mechanism at different positions.

[0033] Preferably, the actuating member of the unlocking mechanism has a guide portion configured to guide the actuating member along a predetermined path, allowing the actuating member to move reliably and preventing the actuating member from moving in other directions that are not required to actuate the locking mechanism.

[0034] Thereby, the guide portion of the actuation member preferably comprises a ring. Such a ring can be disposed around the axial portion of the adapter container to ensure that the actuation member moves only in the axial direction. For example, the ring can be disposed around the post of a mating structure necessary to transfer fluid from the container to the medical delivery device.

[0035] Preferably, the unlocking mechanism includes a retention structure configured to retain the actuation member in the inactivated position. Such retention structure may be embodied by the actuation member engaging a portion of the container adapter, such as the adapter container seat or mating structure. For example, the actuation member, or a stem portion thereof, may include a recess that engages a portion of the adapter container seat.

[0036] Thereby, the actuating member of the unlocking mechanism is preferably configured to elastically deform while the container is placed in the adapter container seat such that the actuating member is disengaged. In particular, when disengaged, the actuating member is not retained. Thus, the actuating member is active, and in particular movable to actuate the locking mechanism of the medical delivery device.

[0037] Additionally, the adapter seat may have a securing structure adapted to permanently hold the container in place, and in particular, the securing structure of the adapter seat may comprise a clip arranged to snap behind the head portion of the container when the container is held in the adapter seat.

[0038] The container adapter can include an alignment formation configured to ensure that the container adapter is in a predetermined orientation relative to the medical delivery device when the mating structure is placed within the container seat of the medical delivery device.

[0039] The joining structure can be configured to form an airtight duct between the interior of the container and the administration mechanism of the medical delivery device when the container is held in the adapter container seat and the joining structure is positioned within the container seat of the medical delivery device.

[0040] The adapter seat may include a spike configured to pierce a cap of an opening of a container when the container is held in the adapter seat. The spike of the adapter seat may include a tip. Further, the spike may have a conduit extending longitudinally through the spike from the tip.

[0041] The container adapter can further include a seal that seals the container seat of the medical delivery device to the mating structure when the mating structure is disposed within the container seat of the medical delivery device. The mating structure can include a seal holder within which the seal is tightly disposed.

[0042] In another aspect, the invention is a delivery assembly including the container adapter described above and a medical delivery device including a container seat for holding a container in place, a dosing chamber, a dosing mechanism for transferring liquid from a container held in the container seat to the dosing chamber, and a locking mechanism adapted to prevent operation of the dosing mechanism when the container is not held in the container seat and to allow operation of the dosing mechanism when the container is held in the container seat.

[0043] The delivery assembly according to the invention and the embodiments thereof described below make it possible to achieve the effects and benefits described above in relation to the container adapter according to the invention and its preferred embodiments.

[0044] The container seat of the medical delivery device preferably has a securing structure adapted to permanently hold the container in place, and the mating structure of the container adapter is arranged to prevent interaction with the securing structure of the container seat of the medical delivery device when the container adapter is held in the container seat of the medical delivery device. For example, the mating structure can be formed to have a smaller diameter in at least one direction compared to the container to prevent interaction. Such a configuration allows the container adapter to be attached to the medical delivery device without being secured by the medical delivery device. In this way, the container adapter can be retracted or removed from the medical delivery device after administration, leaving the medical delivery device ready to accept an additional container or additional container adapter.

[0045] Preferably, the locking mechanism of the medical delivery device includes a push-in portion, and the push-in portion of the locking mechanism and the actuating member of the container adapter are arranged to interact when the container adapter is fed into the container seat of the medical delivery device, such that the push-in portion of the locking mechanism is axially displaced while the mating structure of the container adapter is positioned in the container seat of the medical delivery device and when a container is held in the adapter container seat of the container adapter. The push-in portion can have an abutment surface that contacts a locking mechanism surface of the actuating member of the unlocking mechanism of the container adapter when the locking mechanism of the medical delivery device is actuated. Such a configuration allows the medical delivery device to be unlocked, i.e., the locking mechanism to be actuated, efficiently and automatically when the mating structure of the container adapter is placed in the container seat of the medical delivery device or when the container is placed in the adapter container seat.

[0046] Preferably, the locking mechanism of the medical delivery device includes a tension portion, and the unlocking mechanism of the container adapter includes an engagement surface, the tension portion of the locking mechanism and the engagement surface of the unlocking mechanism being arranged to interengage when the container adapter is advanced into the container seat of the medical delivery device, whereby the tension portion of the locking mechanism is axially displaced when the container adapter is retracted from the medical delivery device. In particular, the unlocking member can tension the locking mechanism when the container adapter is removed. Such a configuration allows for efficient and automatic relocking of the medical delivery device when the container adapter is removed or retracted from the medical delivery device.

[0047] A container adapter according to the invention and a delivery assembly according to the invention are described in more detail below by way of exemplary embodiments and with reference to the accompanying drawings, in which: FIG. [Brief explanation of the drawings]

[0048] [Figure 1] FIG. 1 is a perspective view of one embodiment of a container adapter according to the present invention. [Figure 2] FIG. 2 is a side cross-sectional view of the container adapter of FIG. 1. [Figure 3] 2 is a side cross-sectional view of one embodiment of a delivery assembly according to the present invention including the container adapter of FIG. 1, with a vial not properly seated within the container adapter. [Figure 4] 4 is a cross-sectional side view of the delivery assembly of FIG. 3 with a vial properly placed within the container adapter. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0049] In the following description, certain terminology is used for convenience and is not intended to limit the invention. The terms "right," "left," "up," "down," "under," and "above" refer to directions in the figures. The terms include those explicitly mentioned as well as derivatives and terms of similar meaning. In addition, spatially relative terms such as "beneath," "below," "lower," "above," "upper," "proximal," and "distal" may be used to describe the relationship of one element or feature to another, as shown in the figures. These spatially relative terms are intended to encompass different positions and orientations of the device during use or operation in addition to the position and orientation shown in the figures. For example, if the device in the figures were turned over, elements described as "below" or "below" other elements or features would now be "above" or "above" the other elements or features. Thus, the exemplary term "downward" can encompass both upward and downward positions and orientations. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, descriptions of movement along and about various axes include various particular device positions and orientations.

[0050] To avoid repetition in the figures and descriptions of various aspects and exemplary embodiments, it should be understood that many features are common to many aspects and embodiments. The omission of an aspect from a description or figure does not mean that the aspect is missing from an embodiment incorporating that aspect. Instead, the aspect may be omitted for clarity and to avoid redundant description. In this regard, the following applies to the remainder of this description: For clarity of the drawings, if a drawing includes a reference number that is not described in the directly relevant portion of the description, please refer to the preceding or following description section. Furthermore, for clarity, if not all features of a part are referenced in a drawing, please refer to other drawings showing the same part. Like reference numbers in two or more drawings represent the same or similar elements.

[0051] FIG. 1 shows a perspective view of a vial adapter 1 as one embodiment of a container adapter according to the present invention. The vial adapter 1 includes an upper adapter vial seat 11 as an adapter container seat and a lower connecting structure 12. The adapter vial seat 11 has a ring-shaped upper end portion with a plurality of vertical guide ribs 112 on its inner periphery as alignment formations. The lower end of the adapter vial seat 11 is formed by a base plate 114. The adapter vial seat 11 further includes two lateral clip arms 111 as fixing structures. The connecting structure 12 includes a spike recess 121 having a post portion with an essentially cylindrical outer periphery.

[0052] The vial adapter 1 further includes an unlocking mechanism having an actuating member 13. The actuating member 13 has a guide portion in the form of a ring 134 disposed around the post portion of the spike recess 121 of the mating structure 12. The actuating member further has a stem portion 133 having a lateral recess 135. The stem portion 133 extends vertically upward from the ring 134. The recess 135 opens radially toward the longitudinal adapter central axis 14 of the vial adapter 1. More specifically, the base plate 114 of the adapter vial seat 11 extends into the recess 135 of the actuating member 13 so as to form a retention structure that retains the actuating member 13 in the unactuated position. The uppermost end of the stem portion 133 of the actuating member defines a container surface 131, and the lower end defines a locking mechanism surface 132.

[0053] 2 shows a central cross section of vial adapter 1 along adapter axis 14. It can be seen that adapter spike 113 extends vertically from base plate 114 into the interior of adapter vial seat 11. Adapter spike 113 has a tip and an inner duct that exits radially below the tip. The duct of adapter spike 113 passes through the hollow interior of spike recess 121, which opens downwards.

[0054] As best seen in Figure 2, the stem portion 133 of the actuating member 13 extends from the mating structure 12 above the base plate 114 into the interior of the adapter vial seat 11. In this manner, the actuating member forms a connection between the adapter vial seat 11 and the mating structure 12. The clip arm 113 extends downward from the upper end portion of the adapter vial seat and is angled toward the adapter axis 14.

[0055] FIG. 3 illustrates an embodiment of a delivery assembly 4 according to the present invention, including a medical delivery device 3 and a vial adapter 1. The medical delivery device 3 includes an upper dial unit 31 and a lower housing 34. The dial unit 31 includes a vial seat 33 as a container seat, configured similarly to the adapter container seat 11 described above. Specifically, the vial seat 33 has a bottom base plate 332 from which a spike 331 extends vertically upward. The vial seat 33 further includes a plurality of clip arms 333 as a securing structure inclined toward a central longitudinal device axis 36. The vial adapter 1 is set within or attached to the medical delivery device 3 by disposing the connecting structure 12 within the vial seat 33. The connecting structure 12 is thereby configured so that the clip arms 333 of the vial seat 33 do not engage with or interact with the vial adapter 1. Therefore, the vial adapter 1 is not secured to the medical delivery device 3 and can be removed as needed. The adapter axis 14 is aligned with the device axis 36.

[0056] The spike 331 of the medical delivery device 3 extends into the hollow interior of the spike recess 121 of the vial adapter 1. The needle 35 is located at the bottom end of the spike 331, thereby forming a continuous duct from the needle through the spike 331, where the adapter spike 113 opens into the interior of the adapter vial seat 11.

[0057] The medical delivery device 3 further includes a locking mechanism 32 having a vertical push-in portion 321. In particular, in Figure 3, the locking mechanism 32 is shown in a locked state that prevents rotation of the dial unit 31 relative to the housing 34 about the device axis 36. Thus, in the locked state, the push-in portion 321 of the locking mechanism 32 is positioned a short distance adjacent to the actuation member 13.

[0058] As shown in Figure 3, vial 2 is introduced from top to bottom into adapter vial seat 11. Vial 2 is a conventional glass vial having a body 23 that passes through neck 21 into head 22. Head 22 has an opening closed by a septum-equipped cover. In the situation shown in Figure 3, vial 2 is not fully seated within adapter vial seat 11, i.e., it is not properly held within adapter vial seat 11. This causes the unlocking mechanism of vial adapter 1 to remain in the inactive position.

[0059] 4, however, vial 2 is shown fully seated within adapter vial seat 13, i.e., properly held within adapter vial seat 11, where clip arms 113 of adapter vial seat 13 clip onto the back of head 21 of vial 2, permanently attaching the vial to vial adapter 1. This causes adapter spike 113 to pierce the septum of head 21 of vial 2 such that the interior of vial 2 is accessed by adapter spike 113.

[0060] When the vial 2 is moved from the position shown in FIG. 3 to the position shown in FIG. 4 , the head 22 abuts against the container surface 131 of the actuating member 13. Due to the inclined design of the container surface 131 and the resilience of the stem portion 133, the actuating member 13 is bent outward so that the recess 135 disengages from the base plate 114. Thus, the actuating member 13 is no longer held, and the head 22 of the vial 2 moves downward by being pushed into the actuated position. The locking mechanism surface 132 of the actuating member 13 then abuts against the pushing portion 321 of the locking mechanism 32 of the medical delivery device 3, moving the pushing portion 321 downward. Thus, the locking mechanism 32 is actuated by changing the dial unit 31 to an unlocked state in which it can rotate about the axis 36 relative to the housing 34. Such rotation transfers the liquid inside the vial 2 through the adapter spike 113, the spike 331, and the needle 36 into the dispensing chamber (not shown) of the medical delivery device 3. Thus, the actuation member 13 of the vial adapter 1 makes it possible to prevent operation of the dial unit 31 when the vial 2 is not properly positioned within the adapter vial seat 11 .

[0061] This description and the accompanying drawings illustrating aspects and embodiments of the present invention should not be construed as limiting the scope of the claims defining the protected invention. In other words, while the present invention has been illustrated and described in detail in the drawings and the foregoing description, such illustration and description should be considered exemplary or illustrative, and not limiting. Various mechanical, compositional, structural, electrical, and operational changes can be made without departing from the spirit and scope of the specification and claims. In some instances, well-known circuits, structures, and techniques have not been shown in detail so as not to obscure the invention. It will therefore be understood that changes and modifications can be made by those skilled in the art within the scope and spirit of the following claims. In particular, the present invention encompasses further embodiments having any combination of features from the different embodiments described above and below.

[0062] The present disclosure also individually encompasses all additional features shown in the drawings, which may not be described above or in the following description. Furthermore, single alternatives to the embodiments and single alternatives to the features described in the drawings and description may be discarded from the subject matter of the present invention or disclosed subject matter. The present disclosure includes subject matter consisting of features defined in the claims or exemplary embodiments, as well as subject matter consisting of said features.

[0063] Furthermore, in the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "a" does not exclude a plurality. A single unit or step may fulfill the functions of several features recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. The terms "essentially," "about," "approximately," and the like, in connection with an attribute or value also specifically define that exact attribute or exact value, respectively. The term "about" in the context of a given numerical value or range refers, for example, to a value or range that is within 20%, within 10%, within 5%, or within 2% of the given value or range. Components described as coupled or connected may be directly coupled electrically or mechanically, or indirectly coupled via one or more intermediate components. Any signs in the claims should not be construed as limiting the scope. [Explanation of symbols]

[0064] 1 vial adapter (container adapter) 11 Adapter vial seat (adapter container seat) 111 Clip arm (fixed structure) 112 Guide rib (alignment forming part) 113 Adapter spike 114 Base Plate 12 Joint structure 121 spike recess 13 Actuating member 131 Container Surface 132 Locking mechanism surface 133 Stem part 134 Ring (guide part) 135 Recess (retaining structure) 14 Adapter axis 2 vials (containers) 21 Neck 22 heads 23 Main Unit 3 Medical devices 31 Dial unit 32 Locking mechanism 33 Vial seat (container seat) 331 Spike 332 base plate 333 Clip arm (fixed structure) 34 Housing 35 needles 36 Equipment axis

Claims

1. 1. A container adapter (1) for removably coupling a container (2) to a container seat (33) of a medical delivery device (3), the medical delivery device (3) comprising: the container seat (33) for holding the container (2) in place; a dosing chamber; a dosing mechanism (31) for transferring liquid from the container (2) held in the container seat (33) to the dosing chamber; and a locking mechanism (32) adapted to operate to prevent operation of the dosing mechanism (31) when the container (2) is not held in the container seat (33) and to allow operation of the dosing mechanism (31) when the container (2) is held in the container seat (33), the container adapter (1) comprising: an adapter container seat (11) configured to hold the container (2) in place; a connecting structure (12) configured to be removably disposed within the container seat (33) of the medical delivery device (3) and configured to connect the adapter container seat (11) to the dosing mechanism (31) of the medical delivery device (3) when the connecting structure (12) is disposed within the container seat (33) of the medical delivery device (3); Including, An unlocking mechanism, activating the locking mechanism (32) of the medical delivery device (3) when the joining structure (12) is placed in the container seat (33) of the medical delivery device (3) and the container (2) is properly held in the adapter container seat (11); Preventing actuation of the locking mechanism (32) of the medical delivery device (3) when the container (2) is not properly held within the adapter container seat (11); and a lock release mechanism configured to: the unlocking mechanism includes an actuating member (13) movable relative to the adapter container seat (11) from an inactive position in which the locking mechanism (32) of the medical delivery device (3) is not activated when the joining structure (12) is placed on the container seat (33) of the medical delivery device (3) to an active position in which the locking mechanism (32) of the medical delivery device (3) is activated when the joining structure (12) is placed on the container seat (33) of the medical delivery device (3); the actuating member (13) of the unlocking mechanism is arranged to be moved from the inoperative position to the operative position by the container (2) while the container (2) is set in the adapter container seat (11); The actuating member (13) of the unlocking mechanism has a container surface (131), and the unlocking mechanism is configured such that, while the container (2) is set in the adapter container seat (11), the container (2) contacts the container surface (131) to move the actuating member (13); the actuating member (13) of the unlocking mechanism has a locking mechanism surface (132), and the unlocking mechanism is configured such that when the container (2) is held in the adapter container seat (11) and while the joining structure (12) is disposed in the container seat (33) of the medical delivery device (3), when the container (2) contacts the container surface (131) to move the actuating member (13) to the actuated position, the locking mechanism surface (132) contacts a pushing portion (321) of the locking mechanism (32) of the medical delivery device (3) to actuate the locking mechanism (32) of the medical delivery device (3).

2. 2. The container adapter (1) of claim 1, wherein the actuating member (13) of the unlocking mechanism has a stem portion (133) extending from the adapter container seat (11) to the mating structure (12).

3. 3. A container adapter (1) as described in claim 1 or 2, wherein the container surface (131) is arranged at one longitudinal end of the stem portion (133), and the locking mechanism surface (132) is arranged at the other longitudinal end of the stem portion (133).

4. 4. A container adapter (1) as claimed in any one of claims 1 to 3, wherein the actuating member (13) of the unlocking mechanism has a guide portion (134) configured to define movement of the actuating member (13) along a predetermined path.

5. 5. A container adapter (1) according to claim 4, wherein the guide portion (134) of the actuation member (13) comprises a ring configured to be disposed around an axial portion of the container adapter (1).

6. 6. A container adapter (1) as claimed in any one of claims 1 to 5, wherein the unlocking mechanism includes a retaining structure (135) configured to engage the actuating member (13) to retain the actuating member (13) in the inactivated position.

7. 7. The container adapter (1) of claim 6, wherein the actuating member (13) of the unlocking mechanism is configured to elastically deform while the container (2) is set in the adapter container seat (11) so that the actuating member (13) is disengaged.

8. 8. A delivery assembly (4) comprising: a container adapter (1) according to any one of claims 1 to 7; and a medical delivery device (3), the medical delivery device (3) comprising: a container seat (33) for holding a container (2) in place; a dosing chamber; a dosing mechanism (31) for transferring liquid from the container (2) held in the container seat (33) to the dosing chamber; and a locking mechanism (32) adapted to operate to prevent operation of the dosing mechanism (31) when the container (2) is not held in the container seat (33) and to allow operation of the dosing mechanism (31) when the container (2) is held in the container seat (33).

9. 9. The delivery assembly (4) of claim 8, wherein the container seat (33) of the medical delivery device (3) has a securing structure adapted to non-removably hold the container (2) in place, and the joining structure (12) of the container adapter (1) is arranged to prevent interaction with the securing structure of the container seat (33) of the medical delivery device (3) when the container adapter (1) is held in the container seat (33) of the medical delivery device (3).

10. 10. The delivery assembly (4) of claim 8 or 9, wherein the locking mechanism (32) of the medical delivery device (3) comprises the pushing portion (321) that is axially displaced when pushed by the locking mechanism surface (132) of the actuation member (13) of the unlocking mechanism of the container adapter (1).

11. 11. The delivery assembly (4) of any one of claims 8 to 10, wherein the locking mechanism (32) of the medical delivery device (3) includes a tension portion and the unlocking mechanism of the container adapter (1) includes an engagement surface, the tension portion of the locking mechanism (32) and the engagement surface of the unlocking mechanism being arranged to interengage when the container adapter (1) is advanced into the container seat (33) of the medical delivery device (3), whereby the tension portion of the locking mechanism (32) is axially displaced when the container adapter (1) is retracted from the medical delivery device (3).

Images