Adapter for filling and subsequent closing of a container for pharmaceutical compositions and container with adapter

Abstract

The present invention provides an adapter for filling and subsequently closing a container of a pharmaceutical composition, the adapter comprising: a housing having a first axis, the housing having a cavity having an opening capable of engaging with a port of the container; a closing element disposed in the cavity and capable of being displaced from a first position to a second position in a direction along the first axis; a push rod disposed at least partially outside the cavity and movable by a user in a direction along the first axis to displace the closing element; and the housing having an inlet port having an inlet port opening communicating with the cavity, wherein at least a portion of the inlet port opening is axially located between the first position of the closing element and the opening when viewed along the first axis.

Description

Technical Field

[0001] This disclosure relates to the filling of pharmaceutical containers. This disclosure is particularly, but not exclusively, applicable to adapters for filling and subsequently closing containers of pharmaceutical compositions, such as flat pharmaceutical bags made of plastic. Background Technology

[0002] An exemplary medicine container is a flat medicine bag made of one or more plastics that exhibits excellent barrier properties, allowing for long-term storage like a glass vial. This exemplary medicine container may comprise three main parts: a membrane of one or more layers welded together to form a bag; a port containing an interface and providing access to the interior of the bag; and a closure for closing the port.

[0003] US 8,763,798 B2 relates to a closure for filling and sealing a receiver containing a drug fluid, and a method for filling and sealing the receiver with a drug fluid. The closure used in this method includes a mounting part attachable to the receiver and a connector part connectable to a filling device. A closure body is disposed between the mounting part and the connector part, and a closure part for sealing the closure is located within the closure body. The closure part is slidable between a sealed closure position and an open closure position. The closure is sealed tightly with a removable protective top cover. The receiver is filled through the closure in a cleanroom. After filling, the closure is sealed by pressing the closure part into the closure.

[0004] Such drug containers are typically developed for filling in aseptic, automated filling stations within industrial settings to minimize the risk of contamination. However, this can be inconvenient and involves undesirable logistics. Summary of the Invention

[0005] The object of this invention is to provide a filling tool that allows for the filling of drug containers, and a drug bag designed for filling by practicing physicians, nurses, or pharmacists in industrial or clinical settings, such as treatment rooms or pharmacies. This object is achieved by the characterizing portion of the independent claim. Preferred embodiments are defined in the dependent claims.

[0006] According to a first aspect of this disclosure, an adapter is provided for filling and subsequently closing a container of a pharmaceutical composition, the adapter comprising:

[0007] A housing having a first axis, the housing having a cavity having a cavity opening capable of being connected to a port of the container;

[0008] A closing element, which is disposed in the cavity and is capable of shifting from a first position to a second position in the direction along the first axis;

[0009] A push rod, which is at least partially disposed outside the cavity and is movable by a user in a direction along the first axis, to displace the closing element;

[0010] The housing has an inlet port with an inlet port opening communicating with the cavity, and when viewed along the first axis, at least a portion of the inlet port opening is axially located between the first position of the closing element and the cavity opening.

[0011] According to a preferred aspect, the inlet port has an inlet port channel, at least a portion of the length of which is perpendicular to or inclined relative to the first axis.

[0012] According to a preferred aspect, the adapter has two opposite sides along the first axis, one side being a port on which the adapter can be connected to the container, and the other side being a second side for being held and / or operated by a user.

[0013] According to a preferred aspect, the push rod has a generally T-shaped cross-section along the first axis.

[0014] According to a preferred aspect, the adapter also includes a puncturable diaphragm in the inlet port channel.

[0015] According to a preferred aspect, the inlet port includes one or more of the following at the end opposite to the cavity opening: a self-sealing resilient diaphragm, a pinless connector, a female Luer connector, a male Luer connector, a Luer access valve, a Luer activation device, or a combination thereof.

[0016] According to a preferred aspect, the inlet port is configured to cooperate with at least one or more of a male Luer connector, a female Luer connector, a vial adapter, a vial puncturist, an IV tube assembly puncturist, or a combination thereof.

[0017] According to a preferred aspect, the inlet port is configured to cooperate with at least one closed system transmission device or component.

[0018] According to a preferred aspect, the closure element is adapted to seal the port of the container.

[0019] According to a preferred aspect, the closing element is configured to remove substantially all of the drug from the cavity.

[0020] According to a preferred aspect, the closing element is configured to remove substantially all of the drug from the cavity after the filling and displacement of the closing element.

[0021] According to a preferred aspect, the closure element is adapted to connect to the port of the container and to be released from the adapter when the adapter is removed from the container.

[0022] According to a preferred aspect, the closing element is a plunger for discharging fluid from the cavity.

[0023] According to a preferred aspect, the closure element is essentially an elastomeric material.

[0024] According to a preferred aspect, the closing element is a blend of thermoplastic elastomer and olefin polymer.

[0025] According to a preferred aspect, the cavity is made of an olefin polymer.

[0026] According to a preferred aspect, the adapter is configured such that the adapter or one or more parts of the housing are removed from the container after filling.

[0027] According to a preferred aspect, the adapter is configured such that the adapter or one or more parts of the housing are removed from the container after the filling and displacement of the closing element.

[0028] According to a preferred aspect, the adapter housing has a protruding structure for the user to grip during use, preferably to prevent accidental gripping of other structures. The adapter housing may be generally elongated along this direction of the first axis, and preferably generally cylindrical.

[0029] According to a preferred aspect, the push rod protrudes from the adapter housing along the first axis on the side intended for holding and / or operating by the user.

[0030] According to a preferred aspect, the push rod protrudes from the adapter housing along the first axis on the side intended for holding and / or operating by the user.

[0031] According to a preferred aspect, the adapter housing has one or more connecting elements for connecting the adapter housing to the container housing. The one or more connecting elements provide a releasable connection between the adapter housing and the container housing. This releasable connection can be a snap-fit ​​connection or a threaded connection.

[0032] According to a preferred aspect, the adapter housing has a second axis perpendicular to the first axis, and wherein the adapter housing has two opposing connecting elements along the second axis for connecting the adapter housing to the container housing. The connecting elements may be flexible elements providing a releasable connection to the container housing. Each flexible element may be integral with the adapter housing at one end, and the opposing flexible ends include locking features.

[0033] According to a preferred aspect, the locking feature is a flange that extends in a direction perpendicular to the plane defined by the first axis and the second axis and protrudes along the second axis, or the locking feature is a groove that extends in a direction perpendicular to the plane defined by the first axis and the second axis and is recessed along the second axis.

[0034] According to a preferred aspect, the adapter includes a push rod assembly, wherein the push rod is provided at the push rod assembly. Preferably, the push rod assembly is movable in a direction along a first axis.

[0035] According to a preferred aspect, the adapter further includes a feedback mechanism configured to provide auditory and / or tactile and / or visual feedback signals when or after the closing element is in the second position.

[0036] According to a preferred aspect, the push rod includes an inner rod and a sleeve surrounding the inner rod. Preferably, the sleeve is movable coaxially relative to the inner rod. Preferably, a spring is configured to bias the sleeve toward the container in the first axial direction.

[0037] According to a preferred aspect, the push rod assembly is configured to be pushed to the release position against the force of the spring after the closing element is in the second position, thereby pushing the inner rod into the sleeve.

[0038] According to a preferred aspect, the push rod assembly is configured to release the connection between the connecting element and the container housing when the push rod assembly is in the release position.

[0039] According to a preferred aspect, the push rod assembly is configured to release the connection through mechanical interaction between the housing and the connecting element. Preferably, the mechanical interaction is at least one of pushing, sliding, deflecting, or torsion.

[0040] According to a preferred aspect, the adapter further includes a removable protective element configured to prevent movement of the push rod assembly when attached to the adapter.

[0041] According to a preferred aspect, the protective element is configured as a top cover to cover the push rod assembly. Preferably, the top cover abuts the shoulder of the housing when attached.

[0042] According to a preferred aspect, the protective element is a bracket provided between the housing and the push rod assembly.

[0043] According to a preferred aspect, the protective element is configured to cover the housing except for the side providing the cavity opening.

[0044] According to a preferred aspect, the protective element includes a port cutout that is pivotally connected to the protective element and is configured to allow access to an inlet port.

[0045] According to a preferred aspect, the protective element is configured to cover the adapter connection element.

[0046] According to a preferred aspect, the port cut is configured to prevent the removal of the protective element. Preferably, the port cut is configured to prevent the removal of the protective element when the syringe is attached to the inlet port.

[0047] According to a preferred aspect, the flap is configured to convert the pivotal movement of the flap into the movement of the push rod along the first axis.

[0048] According to a preferred aspect, the push rod assembly includes a receiving recess in a direction perpendicular to the first axis and a blocking member releasably provided in the receiving recess.

[0049] According to a preferred aspect, the blocking member is a pin, a plate-like member, or a member having a U-shape or an O-shape.

[0050] According to a preferred aspect, the shell is formed to be narrower at the central portion than at the end pointing towards the container.

[0051] According to a preferred aspect, the adapter further includes a sliding cover that is movable along the first axis and configured to selectively cover the adapter connecting element.

[0052] According to a preferred aspect, the sliding cover is configured to at least partially cover the housing. In the locked position, the sliding cover is configured to at least partially cover the adapter connection element. In the released position, the sliding cover is configured to expose the adapter connection element.

[0053] According to a preferred aspect, the housing includes at least one leg projecting in a direction along the first axis. Preferably, the at least one leg projects downward. Preferably, if attached, the at least one leg projects toward the container. Preferably, if attached, the at least one leg is configured to contact the outer surface of the container. Preferably, the at least one leg is configured to prevent rotational and / or tilting movement of the housing relative to the container.

[0054] According to a preferred aspect, the push rod is embedded in the adapter housing such that its outermost surface is flush with the surface of the adapter housing. The adapter housing may have a stepped structure, allowing the push rod to be displaced toward the container. The stepped structure may be a generally U-shaped structure.

[0055] According to a preferred aspect, the inlet port includes a valve element for connecting the inlet port to a syringe. The syringe may be a needleless syringe.

[0056] According to another aspect of this disclosure, a container for a pharmaceutical composition is provided, the container having a detachable and removable adapter for filling and subsequently closing the container, the adapter being defined in any of the foregoing aspects, the container further including a medicine pouch and a port configured for removably connecting to the adapter.

[0057] According to the preferred aspect, the medicine bag is a flexible medicine bag, preferably a flat flexible bag.

[0058] According to a preferred aspect, the container also includes a container shell that houses the medicine bag. The port may be part of the medicine bag or part of the container shell.

[0059] According to a preferred aspect, the container housing includes one or more container connection elements that mate with the adapter connection element. Each container connection element may include a locking feature. The locking feature may be a corresponding groove or flange.

[0060] According to another aspect of this disclosure, a container for a flexible bag is provided, the flexible bag having an internal space for containing a volume of liquid, the container comprising:

[0061] A container shell for containing the flexible bag;

[0062] An outlet port is provided to connect the internal space of the flexible bag to the outside of the container; and

[0063] One or more container connecting elements that mate with connecting elements of a flexible bag filling adapter.

[0064] According to a preferred aspect, each container connecting element includes a locking feature.

[0065] According to a preferred aspect, the container shell has a container shell outer shell and a container shell cover.

[0066] According to a preferred aspect, the one or more container locking features include a shell locking feature and a lid locking feature.

[0067] According to a preferred aspect, the container connecting element is formed as a recess in the circumferential wall of the container housing and the container housing lid. The locking feature may be formed as a ridge at the wall of the recess.

[0068] According to a preferred aspect, the container also includes an adapter for filling and subsequently closing the flexible bag within the container.

[0069] According to a preferred aspect, the adapter includes:

[0070] A housing having a cavity having a cavity opening capable of being connected to a port of the container;

[0071] A closing element, which is arranged in the cavity;

[0072] A push rod, which is at least partially disposed outside the cavity and is movable by the user;

[0073] The housing has an inlet port with an inlet port opening communicating with the cavity.

[0074] According to another aspect of this disclosure, a combination of an adapter and a container frame is provided for filling and subsequently closing a container of a pharmaceutical composition, the adapter comprising:

[0075] A housing having a first axis, the housing having a cavity having a cavity opening;

[0076] A closing element, which is disposed in the cavity and is capable of shifting from a first position to a second position in the direction along the first axis;

[0077] A push rod, which is at least partially disposed outside the cavity and is movable by a user in a direction along the first axis, to displace the closing element;

[0078] The housing has an inlet port with an inlet port opening communicating with the cavity, and when viewed along the first axis, at least a portion of the inlet port opening is axially located between the first position of the closing element and the cavity opening;

[0079] The adapter housing has one or more connecting elements for connecting the adapter housing to the container frame.

[0080] According to a preferred aspect, the one or more connecting elements provide a releasable connection between the adapter housing and the container frame.

[0081] According to a preferred aspect, the releasable connection is a snap-fit ​​connection or a threaded connection.

[0082] One advantage of this invention is that it allows for filling drug containers in a variety of scenarios, such as industrial or clinical settings. Attached Figure Description

[0083] The invention will be described with reference to the accompanying drawings, in which:

[0084] Figure 1 This is a perspective view of a container with an adapter according to a first embodiment of the present invention.

[0085] Figure 2 It is according to the first embodiment of the present invention. Figure 1 A front view of a container with an adapter.

[0086] Figure 3 A medicine bag in communication with an adapter is shown according to a first embodiment of the present invention.

[0087] Figure 4 A medicine bag with a container detached from the adapter is shown according to a first embodiment of the present invention.

[0088] Figure 5 An adapter according to a first embodiment of the present invention is shown.

[0089] Figure 6 An exploded perspective view of an adapter according to a first embodiment of the present invention is shown.

[0090] Figure 7 A bottom perspective view of the housing of an adapter according to a first embodiment of the present invention is shown.

[0091] Figure 8 Different exploded perspective views of an adapter according to a first embodiment of the present invention are shown.

[0092] Figure 9 A top perspective view of the housing of an adapter according to a first embodiment of the present invention is shown.

[0093] Figure 10 A cross-sectional perspective view of the housing of an adapter according to a first embodiment of the present invention is shown.

[0094] Figure 11 Perspective views of different cross-sections of the housing of an adapter according to a first embodiment of the present invention are shown.

[0095] Figures 12A to 12D A cross-sectional view of the adapter and container according to the implementation scheme is shown.

[0096] Figures 13A to 13C An adapter with protective elements according to an embodiment is shown.

[0097] Figures 14A to 14D An adapter with protective elements according to an embodiment is shown.

[0098] Figures 15A to 15E The process of removing the protective element according to the implementation scheme is shown.

[0099] Figures 15F to 15H Another embodiment of the adapter including protective elements is shown.

[0100] Figures 16A to 16E A configuration is shown to prevent accidental activation and / or removal of the adapter.

[0101] Figure 17A cross-section of an adapter according to a second embodiment of the present invention is shown.

[0102] Figure 18 An adapter using a second embodiment of the present invention is illustrated.

[0103] Figure 19 Further steps using the adapter of the second embodiment of the present invention are illustrated.

[0104] Figure 20 Details of a container according to an embodiment of the present invention are illustrated.

[0105] Figure 21 Examples Figure 20 An exploded perspective view of the container.

[0106] Figure 22 An internal perspective view of the container shell is shown. Detailed Implementation

[0107] In the diagram, the first axial direction (axis A, length direction) refers to the longitudinal direction along the maximum extension of adapter 100 and container 300. The second axial direction (axis B, width direction) refers to the transverse direction perpendicular to the first axial direction. The third axial direction (axis C, height direction) refers to the height direction perpendicular to the first and second axes. The axes are also... Figure 2 As shown in the image.

[0108] Figure 1 This is a perspective view of a container 300 having an adapter 100 according to a first embodiment of the present invention. Figure 1 An adapter 100 is shown releasably connected to container 300. The adapter 100 has an inlet port, and syringe 400 is shown releasably connected to the adapter 100 at the inlet port. Container 300 has a container housing 320, and a medicine bag (not shown) is located within the container housing 320. The medicine bag in container 300 can be filled from syringe 400 via adapter 100.

[0109] Figure 1 Also shown are the push rod assembly 147 of the adapter 100 and the connecting element that releasably connects the adapter 100 to the housing 320 of the container 300. Figure 1The container connecting element 340 can be seen in the image. This will be described in more detail below. The actuator assembly 147 may appear as a button or the like. The actuator assembly 147 may have a generally T-shaped cross-section along the first axis (A). It can also be seen that, in this embodiment, the top surface of the actuator assembly 147 is flush with the top surface of the adapter housing 110. The top surface of the actuator assembly 147 may be referred to as the outermost end surface 141. However, the flush configuration is optional, and the top surface of the actuator assembly 147 may also protrude from or be recessed relative to the top surface of the adapter housing 100. The functions of the actuator assembly 147 and the actuator 140 will be described in more detail below.

[0110] Figure 1 A second aspect of the invention is also illustrated. The second aspect is a container 300 for a pharmaceutical composition having a detachable and removable adapter 100 for filling and subsequently closing the reservoir 300, both pre-assembled. Thus, according to this aspect of the invention, the container 300 and adapter 100 are provided pre-assembled as a kit. A syringe 400 containing the pharmaceutical composition is provided separately; a medicine bag is filled with the pharmaceutical composition, and the syringe is connected by the user to the adapter 100 of the pre-assembled kit. After the pharmaceutical composition has been filled into the medicine bag and the medicine bag has been closed, the syringe 400 is removed from the adapter 100, and the adapter 100 is detached or released from the container 300. Alternatively, the adapter 100, still connected to the syringe 400, is removed from the container 300.

[0111] Figure 2 It is according to the first embodiment of the present invention having Figure 1 Container 300 Figure 1 A front view of adapter 100. The front view of adapter 100 is defined as a view showing the inlet port 150 (see [reference]). Figure 4 ). Figure 2 It is also shown that the top surface or outermost end surface 141 of the push rod assembly 147 is flush with the top surface 111 of the adapter housing 110. The adapter housing 110 has a first axis A and a second axis B perpendicular to the first axis. Figure 2 In the view, the first axis is a vertical axis, and the second axis is a horizontal axis from left to right. These axes will be referenced below.

[0112] The adapter housing 110 has connecting elements 160 for releasably securing the adapter housing 110 to the container housing 320. In the illustrated embodiment, there are two connecting elements 160 opposite each other, for example, in the sense that they can operate in opposite directions, in the illustrated embodiment by pressing them toward each other. Preferably, when two connecting elements 160 are provided, they are arranged symmetrically with respect to the inlet port into the medicine bag. This symmetrical arrangement allows for simple connection of the adapter 100 to the container 300, because the user does not need to concern themselves with the correct orientation of the adapter 100 relative to the container 300.

[0113] In the illustrated embodiment, the adapter housing 110 is in a vertical plane (e.g., defined by axes A and B). Figure 2 The adapter 100 has a generally rectangular cross-section in the plane of the diagram. It can also have a generally rectangular cross-section in the horizontal plane (i.e., the plane perpendicular to axis A). Two connecting elements 160 are provided on the relatively smaller side of the adapter housing 110. In the illustrated example, the container 300 also has a generally rectangular cross-section in both the horizontal and vertical planes. However, the invention also covers alternative shapes. For example, it is also contemplated that the adapter 100 and / or the container 300 have a square cross-section in the horizontal and / or vertical planes. As another example, the container 300 has an elliptical, semi-circular, or even circular cross-section in the horizontal plane. The cross-section of the adapter 100 can be adapted to be such a cross-section of the container 300, so in an alternative embodiment, the adapter 100 has a circular cross-section in the horizontal plane. In such an alternative embodiment, three connecting elements 160 may be provided, spaced 120° apart from each other around a vertical central axis, and can be operated by a user with three fingers.

[0114] Each connecting element 160 has a locking feature 161 that connects to a mating locking feature 341 of the container connecting element 340, although other arrangements are possible. The connecting element 160 is a flexible element providing a releasable connection to the container housing 320. In the illustrated embodiment, each flexible element is integral with the adapter housing 110 at one end, and the opposing flexible end includes the locking feature 161. The locking feature 161 is a flange extending in a direction perpendicular to the plane defined by axes A and B and projecting along axis B. Alternatively, the locking feature is a groove extending in a direction perpendicular to the plane defined by axes A and B and recessed along axis B. The locking feature 341 of the container 300 is a corresponding mating groove or flange.

[0115] These locking features 161, 341 provide a releasable fixation of the adapter 100 to the container 300 along the first axis A. Alternatively, the locking features 161, 341 are shaped such that sliding movement along the axis of the inlet port 150 (i.e., perpendicular to axis A) is required to engage the adapter 100 to the container 300. As another alternative, the connecting elements 160, 340 have a curved shape (bent around the first axis) or a helical shape, such that the adapter 100 is connected to the container 300 by rotational movement over a certain degree of rotation, thereby causing the connecting elements 160, 340 to slidably engage. With this configuration, the connecting element 160 of the adapter 100 does not need to be flexible, but can be formed as a protrusion of the adapter housing 110.

[0116] Figure 3 A medicine bag of a container 300 in fluid communication with an adapter 100 is shown according to a first embodiment of the invention. In this figure, the container housing 320 is removed so that the medicine bag 310 can be seen.

[0117] Figure 4 A medicine bag 310 of a container released from an adapter 100 according to a first embodiment of the invention is shown. The container housing 320 is also not shown in this figure, and the adapter 100 is shown in a disconnected state, for example, before or after filling the medicine bag 310 and before connecting the adapter to the container 300. The medicine bag 310 has a port 330 to which the adapter 100 can be connected at a corresponding connecting element. Figure 3 and Figure 4 In the diagram, the push rod assembly 147 is shown in its first position, for example, an initial position where the outer surface 141 is flush with the outer surface 111 of the adapter housing 110. Therefore, the push rod 140 (not shown, as it is internally provided), which is described further below, is also in its first / initial position.

[0118] Figure 5 An adapter 100 according to a first embodiment of the invention is shown. In this figure, the push rod assembly 147 and thus the push rod 140 are shown in a state where they have been operated by the user. The push rod 140 has been displaced along a first axis toward a medicine pouch (not shown). Specifically, the push rod 140 has been displaced downward (in the direction of the negative A-axis) by pushing the push rod assembly 147. This can be accomplished, for example, via the outermost end surface 141. Such displacement may require a stepped structure of the adapter housing 110 in some embodiments, which will be explained more clearly below. The housing 110 and the push rod assembly 147 may be provided with a snap-fit ​​connection that locks the push rod assembly 147 in the pushed position. For example, the housing 110 may include a recess or cutout, and one of the walls of the push rod assembly 147 may include a corresponding protrusion engaging the recess or cutout (see...). Figure 6 ).

[0119] Figure 6 An exploded perspective view of an adapter 100 according to a first embodiment of the present invention is shown. Figure 6 An adapter housing 110 is shown, having an adapter connection element 160 and an inlet port 150, the adapter connection element having its flange 161. Figure 6 A portion of cavity 120 of adapter housing 110 is also shown, which opens toward cavity opening 121 for fluid communication with medicine bag 310. Figure 6 The push rod assembly 147 is shown in more detail. The push rod assembly 147 may include a push rod 140, an outermost end surface 141, a side element 142, a recess 143, an O-ring 144, an O-ring 145, and a washer 146. The push rod assembly 147 may also be referred to as a (push) button.

[0120] The closing element 130 may be releasably provided in the cavity 120 as described below, or may be releasably provided on the end surface of the push rod 140 (in the direction of the negative A axis).

[0121] The push rod 140 can be provided inside the push rod assembly 147, such as Figure 6 As shown. Specifically, the push rod 140 may protrude in the direction of axis A (first axis A). For example, the push rod 140 may protrude from the underside of the outermost end surface 141 in the direction of the negative axis A. The push rod 140 may protrude toward the container 300. The push rod 140 is at least partially disposed outside the cavity 120 and is movable by the user in the direction along the first axis A to displace the closure element 130 within the cavity 120. In particular, the push rod 140 may be movable via operation of the push rod assembly 147 (e.g., the outermost end surface 141). The term "at least partially disposed outside the cavity" means Figure 1 The state shown is such that, for example, push rod 140 (not shown) is in its initial position. When push rod 140 is moved toward the medicine bag to achieve the following... Figure 5 In the state shown, the push rod moves into cavity 120 to displace closing element 130. Figure 6 O-rings 144 and 145 and gasket 146 are also shown. O-rings 144 and 145 are located on push rod 140 and cooperate with the inner surface of cavity 120 to provide a fluid tight seal. This helps ensure that the drug composition is discharged from cavity 120 when the drug container 300 is closed. Gasket 146 is located between adapter 100 and container 300 and helps ensure a fluid tight seal between adapter 100 and port 330 of container 300.

[0122] To indicate to the patient that the closure element 130 has been pushed onto the port element 330 of the container 300, thereby sealing the medication bag 310, a feedback mechanism may be provided. This feedback mechanism can be triggered to seal the medication bag 310 after the closure element 130 has been correctly positioned, and provides auditory and / or tactile and / or visual feedback to the patient when the pusher 140 is pushed beyond the final closure element 130 position. Furthermore, this mechanism ensures that the adapter 100 is not prematurely released from the container 300.

[0123] In one embodiment, the push rod 140 can be further subdivided into an inner rod 1401 and a sleeve 1402. The sleeve 1402 can be slidably provided to surround the inner rod 1401. A spring 1403 can be provided that biases the sleeve 1402 downward (i.e., toward the port element 330 (A-axis direction)). The inner rod 1401 can project along a first axis (A-axis). In particular, the inner rod 1401 can project from the underside of the outermost end surface 141 of the push rod assembly 147. The sleeve 1402 can be formed as a substantially hollow cylindrical body. The sleeve 1402 can be configured to slide coaxially relative to the inner rod 1401. Adjacent portions, stops, collars, etc., can limit the maximum extension of the sleeve 1402 relative to the inner rod 1401. The lower end of the sleeve 1402 (i.e., the end pointing toward the container 300) can be configured to releasably accommodate the closure element 130. Sleeve 1402 can be configured to displace closing element 130.

[0124] Spring 1403 can be configured such that the force of spring 1403 is greater than the frictional force between closing element 130 and cavity 120. Therefore, when push rod assembly 147 (button) is actuated, spring 1403 is not compressed or is only slightly compressed, thereby enabling closing element 130 to move from a first position to a second position to seal medicine bag 310.

[0125] The following description may be particularly related to Figures 1 to 11 The illustrated combination of implementation schemes. Unless otherwise stated, Figures 1 to 1 The configurations of 6 are compatible with each other.

[0126] Figure 12A An adapter 100, as described above, is attached to container 300. The adapter 100 is releasably secured to container 300 through the interaction of adapter connecting element 160 and container connecting element 340. Closing element 130 is in its first position and may be provided at the end of sleeve 1402. When push rod assembly 147 is actuated, as... Figure 12B As shown, the push rod 140, consisting of the inner rod 1401 and the sleeve 1402 which is biased downward by the force of the spring 1403, pushes the closing element 130 toward the medicine bag 310 until the port element 330 is closed as described above (closed position of the push rod assembly 147).

[0127] Since the closing element 130 cannot move further, further actuation of the push rod assembly 143 causes compression of the spring 1403. The inner rod 1401 and sleeve 1402 move relative to each other. This further movement causes mechanical interaction between the push rod assembly 147 and the adapter connection element 160, thereby releasing the adapter connection element 160 (the release position of the push rod assembly 147) from the container housing 320 (i.e., the container connection element 340), as... Figure 12C As shown. In Figure 12C In the state shown, adapter 100 can be removed from container 300.

[0128] Mechanical interactions can include pushing, sliding, deflecting, and twisting movements. These interactions can also generate auditory and / or tactile feedback signals ("clicking").

[0129] For example, adapter connection element 160 can be provided within housing 110 (inside, with) Figures 1 to 11 Conversely, this prevents users (pharmacists or patients) from accessing them and prevents the adapter 100 from being accidentally released from the container 300. For example, an adapter connection element 160 may be provided on the inner wall of the housing 110. These may be structurally similar to the adapter connection element 160 described above.

[0130] The adapter 100 can also be connected to the container 300 via a twist lock. The release mechanism of the relative cam surface of the adapter connecting element 160 and the push rod assembly 147 can rotate the twist lock between the adapter 100 and the container 300, thereby releasing the adapter 100 from the container 300.

[0131] Alternatively, the outer wall of the housing 110 may itself form an adapter connection element 160, wherein the locking feature 161 protrudes inward. Figure 12D In the schematically illustrated embodiment, the elongated sidewalls of the push rod assembly 147 (button) can mechanically interact with the adapter connection elements 160, thereby releasing them from the corresponding container connection element 340. The adapter connection elements 160 may taper toward the container connection element 340, such that the push rod assembly 147, as it moves downward as indicated by the arrow, biases and deflects the adapter connection elements 160 outward, thereby releasing engagement with the container connection element 340.

[0132] In other words, the downward movement of the push rod assembly 147 causes the adapter connecting element 160 to bend, thereby releasing the connection between the adapter locking feature 161 and the corresponding container locking feature 341.

[0133] In this configuration, the user cannot accidentally actuate the adapter connection element 160, as he or she can only push them inwards, and therefore the engagement between the adapter locking feature 161 and the corresponding container locking feature 341 cannot be released. To release the connection, the connection element 160 needs to be deflected outwards, as... Figure 12D As shown.

[0134] However, the orientation of the adapter locking feature 161 and the corresponding container locking feature 341 is not limited to the above configuration. Alternatively, the releasable connection between the adapter 100 and the container 300 can be achieved by a cantilever or a hinged snap-fit. Furthermore, downward movement of the push rod assembly 147 can be converted into rotational movement of the adapter locking feature 161 to release the adapter 100 from the container 300.

[0135] Furthermore, the push rod assembly 147 can be held in the pushed position after the aforementioned mechanical interaction. This can be achieved, for example, by locking the corresponding crossbar and protrusion of the push rod assembly 147 in the released position. In this way, visual indication of the sealing of the medicine bag 310 can be provided, such as, for example... Figure 5 As shown.

[0136] In summary, filling the cartridge 300 can be performed as follows. The user connects the syringe 400 to the inlet port 150. A retractable locking tab (adapter connection element 160) holds the adapter 100 in the cartridge 300 without any (exposed) contact points where the user could grasp the adapter 100 and accidentally remove it. When the filling of the medicine bag 310 is complete, the user activates the push rod assembly 147 as described above to place the closure element 130 on the port element 330. The spring 1403 has a compressive force stronger than the force required to slide the closure element 130 into its second position. Therefore, the push rod assembly 147 (button), i.e., the rod 1401, sleeve 1402, and spring 1403, slides together until the closure element 130 reaches its second position (sealed position). As the user continues to press the push rod assembly 147, the spring 1403 compresses, thereby allowing the push rod assembly 147 (button) to continue moving downward along the adapter housing 110. Then, button 147 contacts locking tabs (adapter connecting element 160) and releases their connection to cartridge connecting element 340 through the mechanical interaction described above. This mechanical interaction also generates an audible and / or tactile feedback signal (“click”) to indicate to the user that the pressing action and the closure of the sachet 310 are complete. Therefore, adapter 100 can be removed from cartridge 300.

[0137] According to this configuration, there are no latches or elements that a user could potentially hold and accidentally release from the housing 300 the exposed adapter 100, or such elements are designed to be released internally only by actuating the button 147. Furthermore, a minimal closing force is required before the adapter 100 can be removed. A feedback signal (e.g., a click) and the release of the adapter 100 from the housing 300 occur almost simultaneously or in a closely sequential order, thus confirming to the user that the filling and closing process has been completed.

[0138] In cross-section, the push rod assembly 147 of this exemplary embodiment has a generally T-shape. The vertical portion of the T is formed by a generally cylindrical portion (particularly the push rod 140), and the horizontal portion is formed by a substantially flat plate forming the outer surface 141. Additionally, the push rod 140 may have opposing side elements 142 parallel to the central vertical portion or rod extension, such that the space formed by the push rod 140 is closed and guided by the adapter housing 110. Figure 6 As shown, a side element may have a recess 143 whose shape matches the shape of the inlet port 150 so that it does not interfere with the inlet port 150 when the push rod 140 moves.

[0139] However, the push rod assembly 147 can also be formed as a generally cylindrical or elliptical elongated member, etc. Furthermore, the housing 110 can have a T-shaped or curved shape with a gripping area / feature.

[0140] Figure 6 The stepped structure of the adapter housing 110 is also shown. The stepped structure is generally U-shaped. The stepped structure allows the push rod 140 to start from an initial flush position (e.g., Figure 1 (As shown) Shift to Figure 5 The position is shown. However, as mentioned above, a flush configuration is a design option, and the push rod 140 can also protrude upward from the surface 111 of the adapter housing 110. With this configuration, a stepped structure of the adapter housing 110 is not necessary; that is, the upper surface 111 of the adapter housing is continuous.

[0141] also, Figure 6 A valve element 170, such as a wipeable valve, is shown for attaching, connecting, or coupling a syringe, such as a needleless syringe.

[0142] Figure 7 A bottom perspective view of the housing 110 of an adapter 100 according to a first embodiment of the present invention is shown. Figure 7 In the bottom view, cavity 120 and its arrangement relative to inlet port 150 are clearly visible.

[0143] Figure 8Different exploded perspective views of an adapter 100 according to a first embodiment of the invention are shown. In this figure, an inlet port opening 151 can be seen. At the inlet port opening 151, the inlet port 150 is in fluid communication with a cavity 120 of the adapter housing 110.

[0144] Figure 9 A top perspective view of the housing of an adapter 100 according to a first embodiment of the invention is shown. Also illustrated in this figure are a cylindrical cavity 120 and an inlet port 150.

[0145] Figure 10 A cross-sectional perspective view of the housing 110 of an adapter 100 according to a first embodiment of the invention is shown. The cross-section is drawn in a plane formed by a first axis A and a third axis perpendicular to the first axis A and a second axis B. This cross-section shows an inlet port 150 having its inlet port channel 152 and inlet port opening 151. In this embodiment, the axis of the inlet port channel 152 is perpendicular to the axis of the cavity 120.

[0146] Opening 151 enters cavity 120 at a location along the first axis A, between the closing element 130 in its first position (e.g., initial position) and cavity opening 121. In other words, when viewed along the first axis A, opening 151 is axially located between the first position of closing element 130 and cavity opening 121. The axial position of opening 151 is preferably such that closing element 130 does not overlap with opening 151 in its initial position, and also does not overlap with opening 151 in its final position. However, this disclosure covers partial overlap of one or both of these positions of closing element 130 and opening 151.

[0147] Cavity 120 has a portion with a slightly larger diameter facing the cavity opening 121. This facilitates engagement with port 330 of the medicine bag 310. Cavity 120 also has a portion with a slightly larger diameter facing another end (e.g., the end opposite the end of the cavity opening 121) and on the side of the inlet port 150 away from the cavity opening. This helps to hold the closure element 130 in place before using the adapter 100.

[0148] Figure 11 A perspective view of different cross-sections of the housing of the adapter according to a first embodiment of the invention is shown. These cross-sections are drawn in a plane formed by a first axis A and a second axis B. An opening 151 connecting the inlet port channel 152 to the cavity and a cavity opening 121 are seen.

[0149] To prevent accidental activation of the push rod assembly 147 or push rod 140 and thus premature sealing of the medicine bag 310 by the closing element 130, an accidental closure prevention mechanism may be provided.

[0150] For example, a protective element 148 can be provided that prevents actuation of the push rod assembly 147, and thus prevents actuation of the push rod 140. The protective element 148 can be, for example, a top cover covering the push rod assembly 147, such as... Figure 13A As shown. The push rod assembly 147 cannot be actuated as long as the top cover 148 is attached to the adapter 100. The top cover 148 may be located on the upper shoulder of the housing 110. The top cover 148 may be attached to the housing 110 via a form-fitting feature (e.g., snap-fit ​​or friction). Grip features may be provided to facilitate the removal of the protective element 148.

[0151] Alternatively, the protective element 148 may be provided as a support between the push rod assembly 147 in its initial position and the housing 100, such as... Figure 13B As shown. The bracket 148 can physically prevent activation of the push rod assembly 147 until it is removed. The bracket 148 can be provided in a generally U-shape. The bracket 148 can be supported by the upper shoulder of the housing 110 and the lower surface of the outermost end surface 141. The push rod assembly 147 can have a T-shaped appearance, or it can have a recess or cutout that allows the bracket 148 to be fitted between the housing 110 and the push rod assembly 147.

[0152] Figure 13C Another configuration of the protective element 148 is shown, wherein the protective element can be provided as a protrusion that is grasped by the user and pulled out of the slot to expose the push rod (see [reference]). Figure 13C (See the left image). This protrusion 148 may include indicators such as arrows or textured features to facilitate gripping and make removal readily apparent to the user (see the left image). Figure 13C (The image on the right).

[0153] Alternatively, or as an alternative, such as Figure 14A As shown, a blocking member 1491 may be provided that blocks movement of the push rod assembly 147, and thus blocks movement of the push rod 140 along the A-axis direction until the blocking member 1491 is removed. The push rod assembly 147 may include a receiving recess 1492, such as a slit or hole, configured to receive the blocking member 1491. The receiving recess 1492 may be provided in a third axial direction (C-axis) perpendicular to the first axis (A-axis) and optionally also perpendicular to the second axis (B-axis). When inserted, the blocking member 1491 protrudes in the third axial direction and abuts against the shoulder of the housing 100. This prevents actuation of the push rod assembly 147. When the blocking member 1491 has been removed, the push rod assembly 147 may be actuated to move the closing element 130 from a first position to a second position.

[0154] The blocking member 1491 can be formed as an elongated member (e.g., a pin), and can have a U-shape or a generally O-shape, such as Figure 14AAs shown. It can also be formed as a plate-like member. The receiving recess 1492 can be formed in a corresponding manner to block the member 1491. In the blocking position, the blocking member 1491 can protrude at least partially from the receiving recess 1492, making it easy for the user to remove. That is, the receiving recess 1492 can be formed to be shorter than the length of the blocking member 1491.

[0155] For example, refer to Figure 6 The receiving recess 1492 for receiving the blocking member 1491 can be formed in one or both side elements 142. Typically, since the push rod assembly 147 (button) can have various shapes, the receiving recess 1492 can be provided on at least one side of its lateral side (recessed on the B- / C-axis in the second and / or third axial direction).

[0156] Figure 14B Another possibility for preventing unintentional actuation of the actuator assembly 147 is shown, wherein the blocking member 1491 is formed as an elongated member positioned parallel to the actuator assembly 147. The actuator assembly 147 may be recessed to allow a user's finger to be placed between the elongated member 1491 and the actuator assembly 147, i.e., within a cavity (see [link to documentation]). Figure 14B (Top view). In this position, the elongated member 1491 can be removed at an angle perpendicular to the filling port 150 without obstructing the opposite side of the filling port 150, thereby allowing access to the elongated member 1491 when the filling tool is laid flat (e.g., on the surface of a dispensing cabinet) and the filling port 150 is facing upwards (see top view). Figure 14B (See the bottom middle and right side diagrams). The shape of the slender member 1491 can also be designed to indicate to the user which direction to pull in order to remove it (e.g., as shown in the diagram). Figure 14B (The arrow shape in the lower left image).

[0157] The elongated member 1491 may be connected to the push rod assembly 147 or the housing 110 via a break point. In addition, the elongated member 1491 may be configured to physically impede the movement of the push rod assembly 147 while it is still in the proper position, or to prevent the user from comfortably accessing and actuating the push rod assembly.

[0158] In addition, such as Figure 14C and Figure 14D As shown, it illustrates the following based on Figure 14BIn another configuration of the embodiment, the elongated member 1491 may have a U-shape and may be received in a groove in the protective member 148. The protective member 148 may also function as a button and may therefore be provided with a push rod 140. In this case, the protective member 148 may have a small extension in the B-axis direction (side wall and rear wall), thereby allowing downward movement (i.e., actuation) of the protective member 148, which has the push rod 140 to move the closing element 130 to seal the medicine bag 310. Therefore, the adapter housing 110 may also have a small height. In the initial state, a gap may exist between the upper surface of the adapter housing 110 and the inner surface of the protective element 148, which closes when the protective element 148 moves downward.

[0159] Alternatively, the protective element 148 may be subdivided into a button portion having a push rod 140 (i.e., at the center portion of the protective element 148), which can move independently of the protective element 148.

[0160] Figure 14D yes Figure 14C A cross-sectional perspective view showing the elongated member 1491 inserted in the blocking position. The elongated member 1491 can be positioned on the upward surface 1101 of the adapter housing 110 during insertion (see also...). Figure 15H It may be provided with a blocking protrusion or shoulder 1493, which is configured to abut the inner surface of the protective member 148 (or push rod assembly 147). Therefore, movement of the protective member 148 (or push rod assembly 147) and thus movement of the closing element 130 are blocked. Figure 14D As shown, the shoulder 1493 may protrude in the direction of axis B or in the direction of axis A.

[0161] like Figure 14D As can be seen, because the protective member 148 is supported on the shoulder 1493, it cannot be pushed due to its contact with the upper surface 1101 of the adapter housing 110, i.e., it cannot move in the direction of the A-axis. In other words, the lower part of the elongated member 1491 is clamped between the upper surface 1101 (i.e., the adapter housing 110) and the protective member 148 (or the push rod assembly 147).

[0162] To remove the elongated member 1491, it can be squeezed. That is, the two legs of the elongated member 1491 can be pushed towards each other (inward). This releases the shoulder 1493 from its abutment on the protective member 148, and the elongated member 1491 can be removed from the protective member 148 by pulling it upward (in the direction of axis A). When the elongated members 1491 are pushed together, the groove has a width sufficient to allow the shoulder 1493 to pass through.

[0163] By providing a groove for inserting the elongated member 1491 into the push rod assembly 147, particularly into the outermost end surface 141, the aforementioned mechanism for preventing accidental closure of the medicine bag 310 can also be used without the protective member 148. When the elongated member 1491 is placed in the push rod assembly 147, the inner surface of the push rod assembly 147, as previously described, rests on the shoulder 1493, thereby preventing the push rod assembly 147 from moving downward.

[0164] refer to Figures 15A to 15E The locking interaction between the syringe 400 and the adapter 100 can also be used to prevent the closure element 130 from being placed during syringe 400 connection and dispensing. As described above, a protective element 148 (e.g., a top cap) can be positioned above the push rod assembly 147. When the syringe 400 is attached to the adapter 100, the locking mechanism prevents the protective element 148 from being removed. Therefore, during filling, the medication bag 310 can be prevented from being accidentally closed prematurely by the closure element 130. The locking mechanism can be configured, for example, to engage a pin of the protective element 148 when the syringe 400 is attached to the adapter 100. In the case of a threaded connection of the syringe 400, the pin can move together with the rotational movement of the syringe 400 to engage a corresponding groove or recess at the protective element 148. Therefore, when the syringe 400 is unscrewed, i.e., when the syringe 400 is removed, the pin also turns back, thereby releasing the protective element 148. Furthermore, as long as the syringe 400 is attached to the adapter 100, a latch or the like can lock the removal of the protective element 148. The aforementioned pin or latch may be provided inside the housing 110. The push rod assembly 147 may also include an external feature (e.g., a protrusion or recess) that prevents the push rod from traveling to the necessary position to close the drug bag 310 when the syringe 400 is attached to the filling tool port.

[0165] When the contents of syringe 400 have been completely transferred to medicine bag 310 via adapter 100 ( Figure 15B The syringe 400 is removed from the adapter 100, thereby unlocking the protective element 148 (see...). Figure 15C ).

[0166] In such Figure 15D After the protective element 148 is removed, the push rod assembly 147 can be actuated to close the medicine bag 310.

[0167] Alternatively, the locking mechanism may be formed as, for example, a nose protruding from the push rod assembly 147 / button 147 in a third axial direction (to the right in FIG. 15), which is located on the syringe 400 and thus prevents the push rod assembly 147 from being pushed down as long as the syringe 400 is connected to the adapter 100.

[0168] In other words, the aforementioned closing element mechanism can only be actuated when the syringe 400 is removed from the adapter 100.

[0169] Figures 15F to 15H Another embodiment of the adapter 100, including a protective element 148, is shown. The protective element 148 may be formed as a cover covering the exposed side of the housing 110. That is, the shape of the protective element 148 may substantially conform to the shape of the housing 110. The protective element 148 may cover all sides except the side to which the container 300 may be attached.

[0170] The protective element 148 can be formed as a substantially box-shaped member. The box-shaped member 148 may not have a bottom wall (i.e., a wall facing the container 300 in the negative A-axis direction), so that it can be placed above the housing 110. Figure 15F The sidewall of the box-shaped member 148, corresponding to one side of the inlet port 150 on the housing 110, can be formed as a flap 1481. The flap 1481 can pivot about axis B. The flap 1481 can be hingedly connected to the upper wall of the box-shaped member 148 (i.e., the uppermost wall away from container 300 in the direction of the positive axis A). The flap 1481 may also include a port cutout 1482 at a position corresponding to the inlet port 150 and allowing access to it.

[0171] To fill the medicine bag 310, the syringe 400 is attached to the adapter 100 via the inlet port 150, wherein the box-shaped member 148 is positioned above the housing 110, as... Figure 15F As shown. When the syringe 400 is placed in the port cutout 1482, it prevents the upward removal of the box-shaped member 148. Furthermore, due to the syringe 400, the flap 1481 cannot pivot upwards. Therefore, access to the push rod assembly 147 (button) is blocked, and thus the medicine bag 310 is not accidentally and prematurely sealed by the closing element 130. Additionally, access to the adapter connection element 160 is blocked, and removal of the adapter 100 from the container 300 is prevented.

[0172] After the medication has been transferred to the medication bag 310, the syringe 400 is removed from the inlet port 150. Depending on the type of inlet port 150 used, removing the box-shaped member 148 upwards may still be impossible. However, as Figure 15G As shown, the flap 1481 can pivot upwards. In this way, the box-shaped member 148 can be removed from the housing 100 to allow the user to actuate the push rod assembly 147 and the adapter connection element 160.

[0173] In another embodiment, movement of the flap 1481 can actuate the push rod assembly 147 to move the closing element 130 from a first position to a second position. Specifically, a protrusion projecting toward the housing 110 (or toward the interior space of the box-shaped member 148) can be provided, and this protrusion is configured to convert pivoting movement into downward movement of the push rod assembly 147. Therefore, removal of the protective element / box-shaped member 148 and closure of the medicine bag 310 can be performed in one step.

[0174] As an additional safety mechanism, a handle 180 (e.g., an arched bracket) may be formed at the housing 110, such as... Figure 16A As shown. The handle 180 protects the push rod assembly 147 from accidental activation. To close the container 300, the user inserts their fingers into the handle 180 and pushes the push rod assembly 147 downward as described above.

[0175] In addition, such as Figure 16B As shown, the housing 110 can be shaped such that a user tends to grip the adapter 100 at specific and predetermined locations to prevent accidental actuation of the release mechanism before the closure element 130 is properly positioned. Therefore, the housing 110 can have gripping areas recessed inward (in the B-axis direction) from the outer surface of the housing 110 relative to the adapter connecting element 160. These gripping areas can, for example, be formed as necks or narrow sections on at least one, preferably two, lateral sides (in the B-axis direction) of the housing 110. Thus, the housing 110 can be thinner / narrower at the central portion than at the top and / or bottom (where the bottom portion refers to the end portion facing the adapter connecting element 160 / facing the container 300).

[0176] The grip area encourages the user to keep the adapter 100 in a position away from the adapter connection element 160 (release tab).

[0177] As an alternative solution to prevent accidental activation of the push rod assembly 147, a sliding cover 190 may be provided at the adapter 100. The sliding cover 190 may be movable along a first axial direction (A-axis). It may be movable to selectively cover or expose the release features (particularly the connecting element 160). The sliding cover 190 may partially or completely surround the housing 110. Furthermore, the sliding cover 190 may be guided along the first axial direction (A-axis) in a groove provided on the lateral side of the housing 110. The sliding cover 190 may be connected to the housing 110 in such a way that friction between the two elements is sufficient to hold the sliding cover 190 in place. Alternatively, the sliding cover 190 may be biased downwards, i.e., biased toward the container 300, to impede or block access to the adapter connecting element 160. For example, a spring may be provided between the housing 110 and the sliding cover 190 to push the sliding cover 190 toward the container 300.

[0178] Figure 16C This is a front view of the adapter 100, including the sliding cover 190 as described above. Figure 16D It is a perspective view of a container 300 with an attached adapter 100 having a sliding cover 190. Figure 16D A sliding cover 190 in its upper position is shown, exposing an adapter connection element 160 for separating the adapter 100 from the container 300 after the medication has been transferred into the medicine bag 310 as described above.

[0179] In addition, such as Figure 16E As shown, the sliding cap 190 can substantially completely cover the adapter 100 in the locked position (left figure), except for the inlet port 150. A lateral cutout 191 may also be provided. In the locked position, the user can attach the syringe 400 to the inlet port 150, but cannot reach any actuating member through the lateral cutout 191. Furthermore, the sliding cap 190 is blocked from downward movement by the attached syringe 400. After drug transfer, the syringe 400 can be removed from the adapter 100, and the sliding cap 190 can be pushed downward into the release position. This downward movement can further actuate the push rod assembly 147 to move the closure element 130 from a first position to a second position. In the release position (right figure), the adapter connection element 160 is exposed to remove the adapter 100 from the container 300. The sliding cap 190 may also include an inner protrusion that pushes and releases the adapter connection element 160 when the sliding cap 190 moves in the release position. In this case, the cutout 191 can be omitted.

[0180] The sliding cover 190 can be slidably connected to the housing 110 via a groove and a tongue connection. In addition, the housing 110 may include a guide groove on its outer surface, and the sliding cover 190 may include a corresponding protrusion on its inner surface (and vice versa), thereby allowing the sliding cover 190 to move in the first axial direction.

[0181] Therefore, the process is as follows. The user fills the medicine bag 310 using the adapter 100 as described above and moves the closing element 130 by actuation of the push rod assembly 147. Alternatively, the closing element 130 can move together with the sliding cover 190. The user moves the sliding cover 190, exposing the adapter connection element 160 and allowing the adapter 100 to separate from the container 300. In this way, accidental removal of the adapter 100 from the container 300 during medication transfer or before sealing the medicine bag 310 can be prevented.

[0182] exist Figure 16E In one embodiment, the sliding cover 190 is shown extending beyond the lowest point of the adapter 100 and thus reaching above the container 300. This feature can be applied to all the embodiments described above.

[0183] Specifically, a tongue or leg 192 may be provided to reduce the rotational and tilting degrees of freedom of the adapter 100 relative to the container 300. The leg 192 may protrude from the housing 110 in the direction along the first axis A (negative A-axis direction). If attached, the leg 192 may contact the outer surface of the container 300.

[0184] For example, Figure 1 or Figure 2 The adapter housing 110 shown may have at least two, preferably four, legs, tongues, or protrusions 192 extending downward and over the container 300. The legs 192 may be provided on the front and rear sides of the adapter housing 110 (in the C-axis direction).

[0185] This prevents the adapters (housings) 100, 110 from rotating relative to the container 300. Therefore, a more rigid support for the adapter 100 on the container can be achieved, and the risk of accidental removal of the adapter 100 from the container 300 before the medicine bag 310 is sealed is reduced. The legs, tongue, or protrusion 192 can also reduce the degree of tilt of the adapter 100 relative to the container 300.

[0186] The leg length of 192 can be selected based on the desired stability.

[0187] The configuration described in the context of the adapter is equally valid for containers or combinations of adapters and containers.

[0188] Figure 17 A cross-section of an adapter 500 according to a second embodiment of the invention is shown. In this embodiment, the adapter 500 has a different configuration.

[0189] The adapter 500 of this embodiment has a generally elongated housing 510, and in this preferred embodiment is at least generally cylindrical. The housing 510 defines a cavity 520, which, when the adapter 500 is in use, has a cavity opening 521 at the end facing either the medicine bag 310 or the medicine container 300. At the cavity opening 521, the housing 510 has a structure for mounting the adapter 500 to the container 300. Figure 17 In the diagram, adapter 500 is shown as a port 330 connected to a medicine bag 310 in container 300. Closure element 530 is located in cavity 520. A push rod 540 (also referred to as push rod assembly 540), which may be T-shaped in cross-section, is shown as being at least partially arranged outside (and at least partially inside) cavity 520, and is movable by a user in a direction along a first axis A to displace closure element 530 within cavity 520. Housing 510 has wings 560 for gripping by the user during use of adapter 500.

[0190] The housing 510 has an inlet port 550 with an inlet port opening 551 and an inlet port channel 552. In the illustrated embodiment, the inlet port channel 552 is closed by a diaphragm 555.

[0191] The inlet port channel 552 is shown inclined relative to a first axis A. For example, at least a portion of the length of the inlet port channel 552 is inclined relative to the first axis A (or the second axis B). Therefore, the axis of at least a portion of the length of the inlet port channel 552 lies in the plane defined by axes A and B. In an alternative embodiment, the axis of at least a portion of the length of the inlet port channel 552 may be further inclined relative to the plane defined by axes A and B. However, the inlet port channel 552 may also be oriented perpendicular to the first axis A, as shown in the first embodiment, i.e., oriented along the second axis B. In another alternative embodiment, the inlet port channel 552 may be oriented perpendicular to the first axis A and also inclined relative to the plane defined by axes A and B.

[0192] Opening 551 enters cavity 520 at a location along the first axis A, between the closing element 530 in its first position (e.g., initial position) and cavity opening 521. In other words, when viewed along the first axis A, opening 551 is axially located between the first position of closing element 530 and cavity opening 521. The axial position of opening 551 is preferably such that closing element 530 does not overlap with opening 551 in its initial position, and also does not overlap with opening 551 in its final position. However, this disclosure covers partial overlap of one or both of these positions of closing element 530 and opening 551.

[0193] like Figure 17 As shown, after the main drug container is manufactured, container 300 is (pre-)assembled with adapter 500 for use in pharmacy or clinic filling scenarios. This component can be packaged as a single part. Adapter 500 contains the closure element 530 required for the closure system. The adapter 500 is designed similarly to a syringe, but instead of a plunger, the closure element 530 in the adapter 500 moves within a cavity 520 via a push rod 540. Connection to the adapter cavity 520 via inlet port 550 allows filling of the drug container 300.

[0194] Figure 17 A diaphragm 555 is shown that can be punctured multiple times by a cannula. The diaphragm 555 is arranged in an inlet port channel 552 as a closure at the end of the inlet port 550 opposite to the inlet port opening 551. Alternatively, a Luer connector or both, other non-Luer connectors, or other suitable connectors may be provided. For example, a cooperative connection can be provided for a closed system delivery device (CSTD) or components thereof to prevent user exposure to medication filled into a drug container using the device.

[0195] Figure 18 An adapter 500 using a second embodiment of the invention is illustrated. The left-hand diagram shows the (pre-)assembled adapter 500 and drug container 300. The next stage of use is shown in the right-hand diagram. It shows how the diaphragm 555 is punctured by the filled syringe and how the medication is delivered via the lumen 520 and through the lumen opening 521 into the drug container 300 (the medication flow is highlighted by two arrows). Once the drug container 300 is filled, the syringe is removed by withdrawing, unscrewing, etc. If necessary, one or more additional components can be inserted into the container 300 in this manner. Therefore, the process can be repeated any number of times if needed. For example, if a 50 ml syringe is used with the device and a dose of 100 ml is required in the drug bag, the described process can be repeated twice. Similarly, two 50 ml syringes can each be filled with different medications (e.g., biological drugs and saline) and added to the bag sequentially.

[0196] Figure 19 Further steps using the adapter 500 according to a second embodiment of the present invention are illustrated. Figure 19 The diagram illustrates the blocking and removal of the adapter 500 from the medication container. With all medication components in the medication container 300, press the push rod 540 of the adapter 500. Initially, the closing element 530 acts as a plunger and pushes all medication elements retained in the cavity 520 into the medication container 300. The user can push the push rod 540 with their thumb while simultaneously holding the two wings 560 with their index and middle fingers to apply force to the push rod 540 (see left-hand figure). In the end position (middle figure), the closing element 530 connects to the port, which, for example, snaps in and seals and closes the medication container 300. By further pressing the adapter's push rod 540 (right-hand figure) until the push rod 540 contacts the housing 510, the connection between the closing element 530 and the adapter 500 is released, and the adapter 500 can be removed from the medication container 300 and discarded. The closing element 530 is now positioned on the medication container 300. The diagram on the right shows that the adapter housing 510 has been raised a certain distance from the drug container 300.

[0197] As mentioned above, according to Figures 17 to 19 The push rod 540 of the illustrated embodiment may include a feedback device indicating that the closure of the medicine bag 310 has been completed.

[0198] Figures 20 to 22A container 300 according to one aspect of the invention is shown in more detail. The container 300 is adapted to contain a medicine bag 310. In the illustrated embodiment, the medicine bag 310 is flexible. The medicine bag 310 has an internal space to contain a volume of liquid. The container 300 includes a container housing 320 for containing the flexible bag 310 and, in the illustrated embodiment, supporting the medicine bag 310. The container 300 also has an inlet port (or corresponding outlet port) 343 for receiving or receiving the medicine bag 310, allowing communication between the internal space of the medicine bag 310 and the outside of the container 300. The inlet port 343 is formed as a through-hole. The container 300 has a container housing shell or container frame 322 and a container housing cover 321. When the cover 321 is attached to the shell or frame 322, an internal space for the medicine bag 310 is provided. However, the cover 321 is a preferred element, allowing the container 300 to contain the flexible bag 310 without being closed by the cover 321. The container shell cover 321 and the container shell outer shell 322 each have peripheral walls 323 and 324. The peripheral walls 323 and 324 provide rigidity for the container shell 320.

[0199] Container 300 also has one or more container connecting elements 340. The connecting elements 340 are configured to mate with corresponding connecting elements of flexible bag filling adapters (such as adapters 100, 500 of this disclosure). In the illustrated embodiment, two connecting elements 340 are provided. Preferably, one of the two connecting elements is arranged on each side of the inlet port 343.

[0200] Preferably, each container connection element 340 includes a locking feature 341. More preferably, one or more container locking features 341 include a housing locking feature 3411 and a lid locking feature 3412. In other words, when the container 300 has a lid and the container 300 is coupled to the adapters 100, 500, the adapters 100, 500 are coupled or connected to the container housing housing 322 and the container housing lid 321. This allows for a connection direction along the axis of the port 343. For example, the locking features 3411 and 3412 on the lid and housing provide a snap-fit ​​connection of the adapter to the container 300. Alternatively, the locking features are provided only in the container housing housing 322 and not in the container housing lid 321. With this configuration, the adapters 100, 500 can be coupled to the container 300, for example, with a sliding movement perpendicular to the axis of the port 343.

[0201] exist Figures 20 to 22In the preferred embodiment shown, the container connecting element 340 is formed as a recess in the circumferential walls 323, 324 of the container housing outer shell 322 and the container housing cover 321. A corresponding locking feature 341 is preferably formed as a ridge or flange on the wall of the recess. The ridge or flange can engage with a corresponding flange on the adapter connecting element to releasably connect the two components together.

[0202] Adapters 100, 500, adapter housings 110, 510, and push rods 140, 540 may be made of one or more rigid plastic materials, such as polypropylene, polycarbonate, acrylonitrile butadiene styrene, polyamide, polystyrene, or combinations thereof. In some embodiments, portions of adapter housings 110, 510, and push rods 140, 540 may be overmolded with a soft, compliant material (such as thermoplastic elastomer or thermoplastic polyurethane) on the side closest to the body of container 300 to improve user comfort during filling of container 300 or placement of closure elements 130, 530.

[0203] This disclosure also relates to a system including the aforementioned adapters 100, 500 and box 300, i.e., a combination of adapters 100, 500 and box 300.

[0204] The device described herein can be used to treat and / or prevent one or more of many different types of diseases.

[0205] Exemplary diseases include, but are not limited to: rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g., type 1 or type 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjögren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorders, anemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behçet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetes mellitus). Diseases that may cause macular edema, uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplantation, acute hypoglycemia, obesity, allergic reactions, allergies, sickle cell disease, Alzheimer's disease, Parkinson's disease, Lewy body dementia, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndromes, immunodeficiency (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Leiden factor V), and cancer.

[0206] Exemplary drug types that may be included in the delivery devices described herein include, but are not limited to: small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapy, radioisotopes and / or nuclear drugs, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptides, polypeptides, PEGylated proteins, protein fragments, nucleotides, protein analogs, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T-cell therapy, cell or gene therapy, oncolytic viruses, or immunotherapy.

[0207] Exemplary drugs that may be included in the delivery device described herein include, but are not limited to: immuno-oncology or biological oncology agents, such as immune checkpoints, cytokines, chemokines, differentiation clusters, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or co-stimulatory proteins.

[0208] Exemplary drugs that may be included in the delivery device described herein include, but are not limited to, those exhibiting the proposed mechanisms of action, such as: human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-1 (GLP-1) modulators, glucose-dependent insulinotropic peptide (GIP) modulators, differentiation cluster 38 (CD38) modulators, differentiation cluster 22 (CD22) modulators, C1 esterase modulators, bradykinin modulators, CC chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B cell activator (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, differentiation cluster 79B (CD79B) modulators, tumor-associated calcium signaling transduction protein 2 (Trop-2) modulators, differentiation cluster 52 (CD38) modulators, and differentiation cluster 22 (CD38) modulators. 52) Modulators, B cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, differentiation cluster 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death ligand 1 (PD-1 / PD-L1) inhibitors / modulators, B lymphocyte antigen differentiation cluster 19 (CD19) inhibitors, B lymphocyte antigen differentiation cluster 20 (CD20) modulators, differentiation cluster 3 (CD3) modulators , cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitors, T cell immunoglobulin mucin domain 3 (TIM-3) modulators, T cell immune receptor Ig and ITIM domain-containing modulators (TIGIT) modulators, V domain T cell activation inhibitor (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-associated immunoglobulin domain protein (PVRIG) modulators, lymphocyte activation gene 3 (LAG3);Also known as differentiation cluster 223 (CD223) antagonist, differentiation cluster 276 (CD276 or B7-H3) antigen modulator, differentiation cluster 47 (CD47) antagonist, differentiation cluster 30 (CD30) modulator, differentiation cluster 73 (CD73) modulator, differentiation cluster 66 (CD66) modulator, differentiation cluster w137 (CDw137) agonist, differentiation cluster 158 (CD158) modulator, differentiation cluster 27 (CD27) modulator, differentiation cluster 58 (CD58) modulator, differentiation cluster 80 (CD80) modulator, differentiation cluster 33 (CD33) modulator, differentiation cluster 159 (CD159 or NKG2) modulator, glucocorticoid-induced TNFR-related (GITR) protein modulator, cytotoxic cell immunoglobulin-like receptor (KIR) modulator, growth arrest-specific protein 6 (G Modulators of the AS6 / AXL pathway, APRIL receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B lymphocyte cell adhesion molecule modulators, differentiation cluster w123 (CDw123) modulators, Erbb2 tyrosine kinase receptor modulators, endothelial glycoprotein modulators, mucin modulators, mesothelin modulators, hepatitis A virus cell receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily member 4 (TNFRSF4 or OX40) modulators, adenosine receptor modulators, inducible T cell co-stimulatory molecule (ICOS) modulators, differentiation cluster 40 (CD40) modulators, tumor-infiltrating lymphocyte (TIL) therapy, or T cell receptor (TCR) therapy.

[0209] Exemplary drugs that may be included in the delivery device described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, errinumab, gakanezumab, remimab-vfrm, alicicumab, methotrexate, tocilizumab, interferon β-1a, interferon β-1b, pegylated interferon β-1a, sumatriptan, dapoxetine α, belimumab, sarerucumab, semaglutide, and others. Dupilumab, relizumab, omalizumab, glucagon, adrenaline, naloxone, insulin, amylin, vedolizumab, eculizumab, lavuzizumab, kelzanilizumab-tmca, cytokine, saturizumab (pegylated), saturizumab, denosumab, romozumab, benazeprizumab, emizumab, teirazumab, olizumab, ocrezumab, ocfatumab, natezumab, mepolizumab, resazazumab-rzaaa, ichezumab, and immunoglobulins.

[0210] Exemplary drugs that may be included in the delivery device described herein may also include, but are not limited to, oncology treatments such as: ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, acitumab, ceprimab, rituximab, trastuzumab, trastuzumab emtansine, detrastuzumab, pertuzumab, trastuzumab-pertuzumab, alemtuzumab, mabetoumab- blmf, bevacizumab, berintouzumab, vebutusumab, cetuximab, daratouzumab, ilotusumab, gemutuzumab, yttrium-90 teimozumab, esatatouzumab, moglizazumab, parcitouzumab, octatouzumab, octatouzumab, olazumab, panitumumab, polotouzumab, ramoxituzumab, gosatutuzumab, tancitouzumab, or magitouzumab.

[0211] Exemplary drugs that may be included in the delivery devices described herein include any of the foregoing “generic” or biosimilar equivalents, and the foregoing molecular names should not be construed as limited to “innovator” or “branded” versions of each, as in the non-limiting examples of the innovator drug adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

[0212] Exemplary drugs that may be included in the delivery device described herein also include, but are not limited to, those used as adjuvants or neoadjuvant chemotherapy, such as alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites or topoisomerase inhibitors, enzymes, retinoids or corticosteroids. Exemplary chemotherapy drugs include, for example but not limited to, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dazometazidine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, phenylalanine mustard, methotrexate, pemetrexed, mitomycin, mitoxantrone, tesiromoxim, topotecan, pentorubicin, vincristine, vinblastine, or vinorelbine.

[0213] Exemplary drugs that may be included in the delivery device described herein also include, but are not limited to: analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g., hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, preservatives, anticoagulants, fibrinolytic agents (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytic agents, or diluents such as sterile water for injection (SWFI), 0.9% sodium chloride injection, 0.45% sodium chloride injection, 5% glucose injection, a mixture of 5% glucose and 0.45% sodium chloride, sodium lactate Ringer's injection, heparin Loebrion flushing solution, 100 U / mL heparin Loebrion flushing solution, or 5000 U / mL heparin Loebrion flushing solution.

[0214] Pharmaceutical formulations, including but not limited to any of the drugs described herein, are also considered for use in the delivery devices described herein, such as pharmaceutical formulations comprising the drugs listed herein (or pharmaceutically acceptable salts of drugs) and a pharmaceutically acceptable carrier. Such formulations may contain one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also contain dispersion enhancers (e.g., animal-derived, human-derived, or recombinant hyaluronidase), concentration modifiers or enhancers, stabilizers, buffers, or other excipients, administered alone or co-formulated.

[0215] Exemplary medications that may be included in the delivery devices described herein include, but are not limited to, multi-drug therapy regimens such as AC, dose-dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, dose-dense CHOP, EPOCH, dose-dense adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7+3, 5+ 2, 7+ 4. MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VeIP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC or PE.

[0216] Various modifications to the described embodiments are possible and will be apparent to those skilled in the art without departing from the invention as defined by the appended claims. Unless otherwise stated, the above embodiments can be combined.

Claims

1. An adapter (100, 500) for filling and subsequently closing a pharmaceutical composition container (300), said adapter (100, 500) comprising: A housing (110, 510) having a first axis (A), the housing (110, 510) having cavities (120, 520) having cavity openings (121, 521) capable of being connected to a port of the container (300). Closing elements (130, 530) are arranged in the cavities (120, 520) and are movable from a first position to a second position in the direction along the first axis (A); A push rod (140, 540), which is at least partially disposed outside the cavity (120, 520) and is movable by a user in a direction along the first axis (A) to displace the closing element (130, 530); The housing (110, 510) has an inlet port (150, 550) with an inlet port opening (151, 551) communicating with the cavity (120, 520). When viewed along the first axis (A), at least a portion of the inlet port opening (151, 551) is axially located between the first position of the closing element (130, 530) and the cavity opening (121, 521).

2. The adapter (100, 500) according to claim 1, wherein the inlet port (150, 550) has an inlet port channel (152, 552), at least a portion of the length of the inlet port channel being perpendicular to or inclined relative to the first axis (A).

3. The adapter (100, 500) according to claim 1 or 2, wherein the adapter (100, 500) has two opposite sides along the first axis (A), one side being a side where the adapter (100, 500) can be connected to a port (330) of the container (300), and the other side being a second side for being held and / or operated by a user.

4. The adapter (100, 500) according to any one of the preceding claims, wherein the push rod (140, 540) forms part of a push rod assembly (147, 540) having a generally T-shaped cross-section along the first axis (A).

5. The adapter (100, 500) according to any one of the preceding claims, wherein the adapter (100, 500) further comprises a puncturable diaphragm (555) in the inlet port channel (152, 552).

6. The adapter (100, 500) according to any one of the preceding claims, wherein the inlet port (150, 550) comprises one or more of a self-sealing elastic diaphragm, a pinless connector, a female Luer connector, a male Luer connector, a Luer access valve, a Luer activation device, or a combination thereof at the end opposite to the cavity opening (151, 551).

7. The adapter (100, 500) according to any one of the preceding claims, wherein the inlet port (150, 550) is configured to cooperate with at least one or more of a male Luer connector, a female Luer connector, a vial adapter, a vial puncturist, an IV tube assembly puncturist, or a combination thereof.

8. The adapter (100, 500) according to any one of the preceding claims, wherein the inlet port (150, 550) is configured to cooperate with at least one closed system transmission device or component.

9. The adapter (100, 500) according to any of the preceding claims, wherein the closure element (130, 530) is adapted to seal the port (330) of the container (300) in the second position.

10. The adapter (100, 500) according to any one of the preceding claims, wherein the closing element (130) is configured to remove substantially all of the drug from the cavity (120).

11. The adapter (100, 500) according to any one of the preceding claims, wherein the closing element (130) is configured to remove substantially all of the drug from the cavity (120) after the filling and displacement of the closing element (130, 530).

12. The adapter (100, 500) according to any of the preceding claims, wherein the closure element (130, 530) is adapted to connect to the port (330) of the container (300) and is released from the adapter (100, 500) when the adapter (100, 500) is removed from the container (300).

13. The adapter (100, 500) according to any one of the preceding claims, wherein the closing element (130) is a plunger for discharging fluid from the cavity (120).

14. The adapter (100, 500) according to any one of the preceding claims, wherein the closure element (130, 530) is substantially an elastomeric material.

15. The adapter (100, 500) according to any one of the preceding claims, wherein the closure element (130, 530) is a blend of thermoplastic elastomer and olefin polymer.

16. The adapter (100, 500) according to any one of the preceding claims, wherein the cavity (120, 520) is made of an olefin polymer.

17. The adapter (100, 500) according to any of the preceding claims, wherein the adapter (100, 500) is configured such that one or more portions of the adapter (100, 500) or the housing (110, 510) are removed from the container (300) after filling.

18. The adapter (100, 500) according to any of the preceding claims, wherein the adapter (100, 500) is configured such that one or more portions of the adapter (100, 500) or the housing (110, 510) are removed from the container (300) after the filling and displacement of the closing element (130, 530).

19. The adapter (500) according to any of the preceding claims, wherein the adapter housing (510) has a protruding structure (560) for being gripped by a user during use.

20. The adapter (500) according to claim 19, wherein the adapter housing (510) is generally elongated, preferably generally cylindrical, along the direction of the first axis (A).

21. The adapter (500) according to claim 19 or 20, wherein the push rod (540) protrudes from the adapter housing (510) along the first axis (A) at the side for being held and / or operated by the user.

22. The adapter (100) according to any one of claims 2 to 18, wherein the push rod assembly (147) protrudes from the adapter housing (110) along the first axis (A) at the side for being held and / or operated by the user.

23. The adapter (100) according to claim 22, wherein the adapter housing (110) has one or more connecting elements (160) for connecting the adapter housing (110) to the container housing (320).

24. The adapter (100) of claim 23, wherein one or more connecting elements (160) provide a releasable connection between the adapter housing (110) and the container housing (320).

25. The adapter (100) of claim 24, wherein the releasable connection is a snap-fit ​​connection or a threaded connection.

26. The adapter (100) according to claim 23, 24 or 25, wherein the adapter housing (110) has a second axis (B) perpendicular to the first axis (A), and wherein the adapter housing (110) has two opposing connecting elements (160) for connecting the adapter housing (100) to the container housing (320) and opposite to each other along the second axis (B).

27. The adapter (100) according to claim 26, wherein the connecting element (160) is a flexible element providing a releasable connection to the container housing (320).

28. The adapter (100) according to claim 27, wherein each flexible element is integral with the adapter housing (110) at one end thereof, and the opposing flexible end includes a locking feature (161).

29. The adapter (100) according to claim 28, wherein the locking feature (161) is a flange extending in a direction perpendicular to the plane defined by the first axis (A) and the second axis (B) and protruding along the second axis (B), or the locking feature is a groove extending in a direction perpendicular to the plane defined by the first axis (A) and the second axis (B) and recessed along the second axis (B).

30. The adapter (100, 500) according to any one of the preceding claims, wherein the adapter (100) includes a push rod assembly (147, 540), wherein the push rod (140, 540) is provided at the push rod assembly (147, 540), and The push rod assembly (147, 540) is movable in the direction along the first axis (A).

31. The adapter (100, 500) according to any one of the preceding claims, the adapter further comprising a feedback mechanism configured to provide auditory and / or tactile and / or visual feedback signals when or after the closing element (130, 530) is in the second position.

32. The adapter (100) of claim 31, wherein the push rod (140) comprises an inner rod (1401) and a sleeve (1402) surrounding the inner rod (1401). The sleeve (1402) is capable of moving coaxially relative to the inner rod (1401), and The spring (1403) is configured to bias the sleeve (1402) toward the container (300) in the first axial direction (A).

33. The adapter (100) of claim 32, wherein the push rod assembly (147) is configured to be pushed to a release position against the force of the spring (1403) after the closing element (130) is in the second position, thereby pushing the inner rod (1401) into the sleeve (1402).

34. The adapter (100) according to claim 33, which is dependent on any one of claims 23 to 29, wherein the push rod assembly (147) is configured to release the connection between the connecting element (160) and the container housing (320) when the push rod assembly is in the release position.

35. The adapter (100) of claim 34, wherein the push rod assembly (147) is configured to release the connection via mechanical interaction between the housing (110) and the connecting element (160). Preferably, the mechanical interaction is at least one of pushing, sliding, deflecting, or torsion.

36. The adapter (100) according to any one of claims 30 to 35, the adapter further comprising a removable protective element (148) configured to prevent movement of the push rod assembly (147) when attached to the adapter (100).

37. The adapter (100) of claim 36, wherein the protective element (148) is a top cover configured to cover the push rod assembly (147). The top cover is preferably attached to the shoulder of the housing (110) when attached.

38. The adapter (100) according to claim 36, wherein the protective element (148) is a bracket provided between the housing (110) and the push rod assembly (147).

39. The adapter (100) of claim 36, wherein the protective element (148) is configured to cover the housing (110) except for the side providing the cavity opening (121).

40. The adapter (100) of claim 39, wherein the protective element (148) includes a flap (1481) pivotally coupled to the protective element (148) and includes a port cutout (1482) configured to allow access to the inlet port (150).

41. The adapter (100) according to any one of claims 39 to 40, which are dependent on any one of claims 23 to 29, wherein the protective element (148) is configured to cover the adapter connection element (160).

42. The adapter (100) according to claim 40 or 41, wherein the port cutout (1482) is configured to prevent the removal of the protective element (148), Preferably, the port cut (1482) is configured to prevent the removal of the protective element (148) when the syringe (400) is attached to the inlet port (150).

43. The adapter (100) according to any one of claims 39 to 42, wherein the flap (1481) is configured to convert pivotal movement of the flap (1481) into movement of the push rod (140) along the first axis (A).

44. The adapter (100) according to any one of claims 30 to 43, wherein the push rod assembly (147) includes a receiving recess (1492) in a direction perpendicular to the first axis (A) and a blocking member (1491) releasably provided in the receiving recess.

45. The adapter (100) according to claim 44, wherein the blocking member (1491) is a pin, a plate-like member, or a member having a U-shape or an O-shape.

46. ​​The adapter (100) according to any one of the preceding claims, wherein the housing (110) is formed to be narrower at the central portion than at the end pointing toward the container (300).

47. The adapter (100) according to any one of claims 23 to 46, the adapter further comprising a slide cover (190) movable along the first axis (A) and configured to selectively cover the adapter connecting element (160).

48. The adapter (100) of claim 47, wherein the sliding cover (190) is configured to at least partially cover the housing (110), and In the locked position, the sliding cover (190) is configured to at least partially cover the adapter connection element (160), and In the released position, the slide cover (190) is configured to expose the adapter connection element (160).

49. The adapter (100) according to any one of claims 1 to 48, wherein the housing (110) includes at least one leg (192) projecting in a direction along the first axis (A). The at least one leg (192) is configured to prevent the housing (110) from rotating and / or tilting relative to the container (300).

50. The adapter (100) according to any one of claims 1 to 49, wherein the push rod (140) forms part of a push rod assembly (147), wherein the push rod assembly (147) is embedded in the adapter housing (110) such that the outermost end surface (141) is flush with the surface (111) of the adapter housing (110).

51. The adapter (100) of claim 50, wherein the adapter housing (110) has a stepped structure that allows the push rod assembly (147) to be displaced toward the container (300).

52. The adapter (100) according to claim 51, wherein the stepped structure is a generally U-shaped structure.

53. The adapter (100) according to any one of the preceding claims, wherein the inlet port (150) includes a valve element (170) for connecting the inlet port (150) to the syringe (400).

54. The adapter (100) according to claim 53, wherein the syringe (400) is a needle-free syringe.

55. A container (300) for a pharmaceutical composition, the container having a detachable and removable adapter (100, 500) for filling and subsequently closing the container (300). The adapter (100, 500) is as defined in any of the preceding claims. The container (300) also includes: Medicine bag (310), and Port (330), which is configured to be removably connected to the adapter (100).

56. The container (300) according to claim 55, wherein the medicine bag (310) is a flexible medicine bag, preferably a flat flexible bag.

57. The container (300) of claim 56, wherein the container (300) further comprises a container shell (320) for receiving the medicine bag (310).

58. The container (300) of claim 57, wherein the port (330) is part of the medicine bag (310) or part of the container housing (320).

59. The container (300) according to claim 57 or 58, wherein the container housing (320) includes one or more container connecting elements (340) that mate with the adapter connecting element (160).

60. The container (300) according to claim 59, wherein each container connecting element (340) includes a locking feature (341).

61. The container (300) according to claim 60, wherein the locking feature (341) is a corresponding groove or flange.

62. A container (300) for a flexible bag (310), the flexible bag having an internal space for containing a volume of liquid, the container (300) comprising: Container shell (320) for accommodating the flexible bag (310). An outlet port (343) for communicating the interior space of the flexible bag (310) with the exterior of the container (300); and One or more container connecting elements (340) cooperate with connecting elements (160) of the flexible bag filling adapter (100).

63. The container (300) according to claim 62, wherein each container connecting element (340) includes a locking feature (341).

64. The container (300) according to claim 62 or 63, wherein the container shell (300) has a container shell outer shell (322) and a container shell cover (321).

65. The container (300) according to claim 64, wherein the one or more container locking features (341) include a shell locking feature (3411) and a lid locking feature (3412).

66. The container (300) according to any one of claims 62 to 65, wherein the container connecting element (340) is formed as a recess in the circumferential walls (323, 324) of the container housing shell (322) and the container housing cover (321).

67. The container (300) according to claim 66, wherein the locking feature (341) is formed as a ridge at the wall of the recess.

68. The container (300) according to any one of claims 62 to 67, the container further comprising an adapter (100, 500) for filling and subsequently closing the flexible bag (310) in the container (300).

69. The container of claim 68, wherein the adapter (100, 500) comprises: The housing (110, 510) has cavities (120, 520) with cavity openings (121, 521) capable of being connected to a port of the container (300). Closure elements (130, 530) are arranged in the cavities (120, 520); A push rod (140, 540), which is at least partially disposed outside the cavity (120, 520) and is movable by the user; The housing (110, 510) has an inlet port (150, 550) with an inlet port opening (151, 551) communicating with the cavity (120, 520).

70. A combination of an adapter (100, 500) and a container frame (322) for filling and subsequently closing a pharmaceutical composition container (300), said adapter (100, 500) comprising: A housing (110, 510) having a first axis (A), the housing (110, 510) having cavities (120, 520) having cavity openings (121, 521). Closing elements (130, 530) are arranged in the cavities (120, 520) and are movable from a first position to a second position in the direction along the first axis (A); A push rod (140, 540), which is at least partially disposed outside the cavity (120, 520) and is movable by a user in a direction along the first axis (A) to displace the closing element (130, 530); The housing (110, 510) has an inlet port (150, 550) with an inlet port opening (151, 551) communicating with the cavity (120, 520). When viewed along the first axis, at least a portion of the inlet port opening (151, 551) is axially located between the first position of the closing element (130, 530) and the cavity opening (121, 521). The adapter housing (110) has one or more connecting elements (160) for connecting the adapter housing (110) to the container frame (322).

71. The adapter (100) of claim 70, wherein one or more connecting elements (160) provide a releasable connection between the adapter housing (110) and the container frame (322).

72. The adapter (100) of claim 71, wherein the releasable connection is a snap-fit ​​connection or a threaded connection.

Images