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WO2025111000A1 - Adaptateur pour le remplissage et la fermeture ultérieure d'un contenant de composition pharmaceutique, et contenant pourvu d'un adaptateur - Google Patents

Adaptateur pour le remplissage et la fermeture ultérieure d'un contenant de composition pharmaceutique, et contenant pourvu d'un adaptateur Download PDF

Info

Publication number
WO2025111000A1
WO2025111000A1 PCT/US2023/080899 US2023080899W WO2025111000A1 WO 2025111000 A1 WO2025111000 A1 WO 2025111000A1 US 2023080899 W US2023080899 W US 2023080899W WO 2025111000 A1 WO2025111000 A1 WO 2025111000A1
Authority
WO
WIPO (PCT)
Prior art keywords
adapter
container
housing
push rod
axis
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2023/080899
Other languages
English (en)
Inventor
Christoph EGLOFF
Urs Jann
Lukas Bannwart
Mariano MUMPOWER
Christopher James FRANZESE
Florence Olivia STEVENSON
Joshua Thomas HARTL
Chester Boyd LARROW
James Thomas HAWTHORNE
Allison Marie SHEARS
Martin Michael COYNE III
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shl Pharma LLC
Original Assignee
Shl Pharma LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shl Pharma LLC filed Critical Shl Pharma LLC
Priority to PCT/US2023/080899 priority Critical patent/WO2025111000A1/fr
Publication of WO2025111000A1 publication Critical patent/WO2025111000A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/04—Methods of, or means for, filling the material into the containers or receptacles
    • B65B3/045—Methods of, or means for, filling the material into the containers or receptacles for filling flexible containers having a filling and dispensing spout, e.g. containers of the "bag-in-box"-type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/04—Methods of, or means for, filling the material into the containers or receptacles
    • B65B3/10—Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material
    • B65B3/12—Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material mechanically, e.g. by pistons or pumps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B39/00—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers
    • B65B39/06—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers adapted to support containers or wrappers
    • B65B39/08—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers adapted to support containers or wrappers by means of clamps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/02—Closing containers or receptacles deformed by, or taking-up shape, of, contents, e.g. bags, sacks

Definitions

  • the present disclosure relates to the filling of a drug container.
  • the disclosure is particularly, but not exclusively, applicable to an adapter for filling and subsequently closing a pharmaceutical composition container, such as a flat medicament bag made of plastics.
  • An exemplary drug container is a flat medicament bag made of one or more plastics showing excellent barrier properties that may allow long storage like glass vials.
  • Such an exemplary drug container may contain three main parts: a film of one or more layers, which is welded to form a bag; a port, which contains interfaces and provides access to the interior of the bag; and a closure to close the port.
  • US 8 763 798 B2 relates to a closure for filling and sealing receptacles containing medicinal fluids, a method for filling a receptacle with a medicinal fluid and sealing the receptacle.
  • the closure used in the method comprises a mounting piece that may be attached to the receptacle and a connector piece that may be connected to a connector piece of a filling device.
  • a closure body is arranged between the mounting piece and the connector piece, in which a closure piece for sealing the closure sits.
  • the closure piece may be slid between a position sealing the closure and a position which opens the closure.
  • the closure is sealed tight with a removable protective cap.
  • the receptacle is filled through the closure in a clean room. After filling, the closure is sealed by pressing the closure piece into the closure.
  • Such drug containers have generally been developed to be filled in industrial environment on an automated filling station in aseptic environment, in order to minimize the risk of contamination. However, this can be inconvenient and involve undesirable logistics.
  • An object of the invention is to provide a filling tool that allows for the filling of a drug container and to provide a medicament bag designed for being filled in either an industrial environment or in a clinical setting, such as a treatment room or pharmacy, by a medical practitioner, nurse or pharmacist. This object is achieved with the features of the independent claims. Preferred embodiments are defined in the dependent claims.
  • an adapter for filling and subsequent closing of a pharmaceutical composition container comprising: a housing having a first axis, the housing having a cavity with a cavity opening coupleable to a port of the container; a closure element arranged in the cavity and displaceable from a first position to a second position, in a direction along the first axis; a push rod being arranged at least partially outside the cavity and being movable by a user in a direction along the first axis for displacing the closure element; the housing having an entry port with an entry port opening in communication with the cavity, at least part of the entry port opening being located axially between the first position of the closure element and the cavity opening when viewed along the first axis.
  • the entry port has an entry port channel, at least part of the length of which is perpendicular to or is inclined with respect to the first axis.
  • the adaptor has two opposing sides along the first axis, one side being the side where the adapter is connectable to a port of the container, the other, second side for being held and/or operated by a user.
  • the push rod has a generally T-shape in cross-section along the first axis.
  • the adapter further comprises a pierceable septum in the entry port channel.
  • the entry port comprises one or more of a self-sealing elastomeric septum, needleless connector, female Luer connection, male Luer connection, Luer access valve, Luer activated device, or combinations thereof, at the end opposite to the cavity opening.
  • the entry port is configured to cooperate with at least one or more of a male Luer connector, female Luer connector, vial adapter, vial spike, IV tubing set spike, or combinations thereof.
  • the entry port is configured to cooperate with at least one closed-system transfer device or component.
  • the closure element is adapted to seal the port of the container.
  • the closure element is configured to remove substantially all of a drug from the cavity.
  • the closure element is configured to remove substantially all of a drug from the cavity after filling and displacement of the closure element.
  • the closure element is adapted to enter into a connection with the port of the container and to be released from the adapter upon removal of the adapter from the container.
  • the closure element is a plunger for expelling fluid from the cavity.
  • the closure element is a substantially elastomeric material.
  • the closure element is a blend of thermoplastic elastomer and an olefin polymer.
  • the cavity is made from an olefin polymer.
  • the adapter is configured such that one or more portions of the adapter or the housing are removed from the container after filling.
  • the adapter is configured such that one or more portions of the adapter or the housing are removed from the container after filling and displacement of the closure element.
  • the adapter housing has a protruding structure for being gripped by a user during use, preferably to avoid inadvertent gripping of other structures.
  • the adapter housing may be generally elongate along the direction of the first axis, preferably generally cylindrical.
  • the push rod protrudes along the first axis from the adapter housing at the side for being held and/or operated by a user.
  • the push rod protrudes along the first axis from the adapter housing at the side for being held and/or operated by a user.
  • the adapter housing has one or more connecting elements for connecting the adapter housing with the container housing.
  • the one or more connecting elements may provide a releasable connection between the adapter housing with the container housing.
  • the releasable connection may be a snap connection or a screw connection.
  • the adapter housing has a second axis perpendicular to the first axis, and wherein the adapter housing has two opposite connecting elements for connecting the adapter housing with the container housing, opposite along the second axis.
  • the connecting elements may be flexible elements providing a releasable connection to the container housing.
  • Each flexible element may be at its one end integral with the adapter housing and the opposite flexible end comprising a locking feature.
  • the adapter comprises a push rod assembly wherein the push rod is provided at the push rod assembly.
  • the push rod assembly is movable in the direction along the first axis.
  • the adapter further comprises a feedback mechanism configured to provide an audible and/or tactile and/or visual feedback signal when or after the closure element is in the second position.
  • the push rod comprises an inner rod and a sleeve surrounding the inner rod.
  • the sleeve is coaxially movable with respect to the inner rod.
  • a spring is configured to bias the sleeve in the first axis direction towards the container.
  • the push rod assembly is configured to be pushed against a force of the spring in a releasing position after the closure element is in the second position, thereby pushing the inner rod in the sleeve.
  • the push rod assembly is configured to release a connection between the connection elements and the container housing when the push rod assembly is in the releasing position.
  • the push rod assembly is configured to release the connection by a mechanical interaction of the housing and the connecting elements.
  • the mechanical interaction is at least one of pushing, sliding, deflecting, or twisting.
  • the adapter further comprises a detachable protective element configured to, when attached to the adapter, prevent movement of the push rod assembly.
  • the protective element is a cap configured to cover the push rod assembly.
  • the cap abuts a shoulder of the housing when attached.
  • the protective element is a bracket provided between the housing and the push rod assembly.
  • the protective element is configured to cover the housing apart from a side, where the cavity opening is provided.
  • the protective element comprises a flap pivotably coupled to the protective element and comprising a port cut-out configured to allow access to the entry port.
  • the protective element is configured to cover the adapter connecting elements.
  • the port cut-out is configured to block removal of the protective element.
  • the port cut-out is configured to block removal of the protective element when a syringe is attached to the entry port.
  • the flap is configured to translate a pivot movement of the flap into movement of the push rod along the first axis.
  • the push rod assembly comprises a receiving recess in a direction perpendicular to the first axis and a blocking member releasably provided in the receiving recess.
  • the blocking member is a pin, a plate-like member or a member having a U-shape or O-shape.
  • the housing is formed to be narrower at a centre portion than at an end directed towards the container.
  • the adapter further comprises a sliding cover moveable along the first axis and configured to selectively cover the adapter connecting elements.
  • the sliding cover is configured to at least partially cover the housing. In a locking position, the sliding cover is configured to at least partially cover the adapter connecting elements. In a releasing position, the sliding cover is configured to expose the adapter connecting elements.
  • the housing comprises at least one leg protruding in a direction along the first axis.
  • the at least one leg protrudes downwards.
  • the at least one leg protrudes towards the container, if attached.
  • the at least one leg is configured to contact an outer surface of the container, if attached.
  • the at least one leg is configured to prevent rotational movement and/or tilting movement of the housing with respect to the container.
  • the push rod is embedded in the adapter housing such that the outermost end surface is flush with a surface of the adapter housing.
  • the adapter housing may have a stepped structure so that the push rod is displaceable towards the container.
  • the stepped structure may be generally a U-shaped structure.
  • the entry port comprises a valve element for connecting the entry port with a syringe.
  • the syringe may be a needleless syringe.
  • a container for a pharmaceutical composition having a separable and removable adapter for filling and subsequent closing of the container, the adapter as defined in any one of the preceding aspects, the container further comprising a medicament bag, and a port configured for being removably connected with the adapter.
  • the medicament bag is a flexible medicament bag, preferably a flat flexible bag.
  • the container further comprises a container housing accommodating the medicament bag.
  • the port may be part of the medicament bag or part of the container housing.
  • the container housing comprises one or more container connecting elements mating with the adapter connecting elements.
  • Each container connecting element may comprises a locking feature.
  • the locking feature may be a corresponding groove or ledge.
  • a container for a flexible bag having an inner space to accommodate a volume of liquid
  • the container comprising: a container housing for accommodating the flexible bag; an outlet port for communication of the inner space of the flexible bag with the exterior of the container; and one or more container connecting elements mating with connecting elements of a flexible bag filling adapter.
  • each container connecting element comprises a locking feature.
  • the container housing has a container housing case and a container housing lid.
  • the one or more container locking feature comprise a case locking feature and a lid locking feature.
  • the container connecting element is formed as a recess in the circumferential walls of the container housing case and the container housing lid.
  • the locking feature may be formed as a ridge at the wall of the recess.
  • the container further comprises an adapter for filling and subsequent closing of the flexible bag in the container.
  • the adapter comprises: a housing having a cavity with a cavity opening coupleable to a port of the container; a closure element arranged in the cavity; a push rod being arranged at least partially outside the cavity and being movable by a user; the housing having an entry port with an entry port opening in communication with the cavity.
  • an adapter for filling and subsequent closing of a pharmaceutical composition container and a container frame comprising: a housing having a first axis, the housing having a cavity with a cavity opening; a closure element arranged in the cavity and displaceable from a first position to a second position, in a direction along the first axis; a push rod being arranged at least partially outside the cavity and being movable by a user in a direction along the first axis for displacing the closure element; the housing having an entry port with an entry port opening in communication with the cavity, at least part of the entry port opening being located axially between the first position of the closure element and the cavity opening when viewed along the first axis; wherein the adapter housing has one or more connecting elements for connecting the adapter housing with the container frame.
  • the one or more connecting elements provide a releasable connection between the adapter housing with the container frame.
  • the releasable connection is a snap connection or a screw connection.
  • One advantage of the invention is that it allows for filling the drug container in multiple scenarios, e.g. in an industrial environment or in a clinical setting.
  • Fig. 1 is a perspective view of a container with an adapter according to a first embodiment of the present invention.
  • Fig. 2 is a front view of the container with an adapter of Fig. 1 according to the first embodiment of the present invention.
  • Fig. 3 shows the medicament bag of the container in communication with the adapter according the first embodiment of the present invention.
  • Fig. 4 shows the medicament bag of the container decoupled from the adapter according the first embodiment of the present invention.
  • Fig. 6 shows an exploded perspective view of the adapter according to the first embodiment of the present invention.
  • Fig. 7 shows a perspective bottom view of the housing of the adapter according to the first embodiment of the present invention.
  • Fig. 8 shows a different exploded perspective view of the adapter according to the first embodiment of the present invention.
  • Fig. 9 shows a perspective top view of the housing of the adapter according to the first embodiment of the present invention.
  • Fig.10 shows a perspective cross-sectional view of the housing of the adapter according to the first embodiment of the present invention.
  • Fig. 11 shows a perspective view of a different cross-section of the housing of the adapter according to the first embodiment of the present invention.
  • Figs. 12A to 12D show cross-sectional views of an adapter and a container according to an embodiment.
  • Figs. 13A to 13C show an adapter having a protective element according to an embodiment.
  • Figs. 14A to 14D show an adapter having a protective element according to embodiments.
  • Figs. 15A to 15E show a process of removing a protective element according to an embodiment.
  • Figs. 15F to 15H show further embodiments of an adapter comprising a protective element.
  • Fig. 16A to 16E show configurations of preventing accidental activation and/or removal of the adapter.
  • Fig. 17 shows a cross-section of an adapter according to a second embodiment of the present invention.
  • Fig. 18 illustrates the use of the adapter of the second embodiment of the present invention.
  • Fig. 19 illustrates further steps of the use of the adapter of the second embodiment of the present invention.
  • Fig. 20 illustrates details of the container according to an embodiment of the present invention.
  • Fig. 21 illustrates an exploded perspective view of the container of Fig. 20.
  • Fig. 22 illustrates a perspective inner view of the container housing case.
  • the first axis direction (A-axis, length direction) refers to a longitudinal direction along the highest elongation of the adapter 100 and the container 300.
  • the second axis direction (B-axis, width direction) refers to a lateral direction perpendicular to the first axis direction.
  • the third axis direction (C-axis, height direction) refers to a height direction perpendicular to the first and the second axis.
  • the axes are also shown in Fig. 2.
  • Fig. 1 is a perspective view of a container 300 with an adapter 100 according to a first embodiment of the present invention.
  • Fig. 1 shows the adapter 100 releasably coupled to the container 300.
  • the adapter 100 has an entry port and a syringe 400 is shown releasably connected to the adapter 100 at the entry port.
  • the container 300 has a container housing 320, and a medicament bag (not shown) is in the container housing 320.
  • the medicament bag in the container 300 can be filled from the syringe 400 via the adapter 100.
  • Fig. 1 also shows a push rod assembly 147 of the adapter 100 and the connecting elements releasably connecting the adapter 100 to the housing 320 of the container 300.
  • Fig. 1 also shows a push rod assembly 147 of the adapter 100 and the connecting elements releasably connecting the adapter 100 to the housing 320 of the container 300.
  • the container connecting element 340 is seen.
  • the outer appearance of the push rod assembly 147 may be a push button or the like.
  • the push rod assembly 147 may have a generally T-shape in cross section along the first axis (A). It can also be seen that in this embodiment the top surface of the push rod assembly 147 is flush with the top surface of the adapter housing 110.
  • the top surface of the push rod assembly 147 may be referred to as an outermost end surface 141. However, the flush configuration is optional, the top surface of the push rod assembly 147 can also protrude from the top surface of the adapter housing 100 or be recessed in relation thereto.
  • the function of the push rod assembly 147 and the push rod 140 will be described in more detail below.
  • Fig. 1 also illustrates the second aspect of the invention.
  • the second aspect is a ccontainer 300 for a pharmaceutical composition having a separable and removable adapter 100 for filling and subsequent closing of the container 300, both being pre-assembled.
  • the container 300 and the adapter 100 are provided preassembled as a kit set.
  • the syringe 400 containing the pharmaceutical composition with which the medicament bag is to be filled is provided separately and is connected by the user to the adapter 100 of the pre-assembled kit.
  • the syringe 400 is removed from the adapter 100, and the adapter 100 is decoupled or released from the container 300.
  • the adapter 100 with the syringe 400 still being connected to it is removed from the container 300.
  • Fig. 2 is a front view of an adapter 100 of Fig. 1 with the container 300 of Fig. 1 according to the first embodiment of the present invention.
  • the front view of the adapter 100 is defined as the view showing the entry port 150 (see Fig. 4).
  • Fig. 2 also shows 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.
  • the first axis is the vertical axis
  • the second axis is a horizontal axis from left to right. Reference will be made to these axes below.
  • the adapter housing 110 has a connecting element 160 for releasably securing the adapter housing 110 to the container housing 320.
  • a connecting element 160 for releasably securing the adapter housing 110 to the container housing 320.
  • there are two connecting elements 160 opposed to one another, e.g. in the sense that they are operable in opposing directions - in the illustrated embodiment by being pressed towards one another.
  • two connecting element 160 are provided, they are arranged in symmetry with respect to the entry port into the medicament bag. Such symmetrical arrangement allows for a simple coupling of the adapter 100 of the container 300 because the user does not have to care about correct orientation of the adapter 100 with respect to the container 300.
  • the adapter housing 110 has a generally rectangular cross section in the vertical plane (e.g., the plane of the drawing of Fig. 2 defined by axes A and B). It may also have a generally rectangular cross-section in the horizontal plane (i.e., the plane to which axis A is perpendicular).
  • the two connecting elements 160 are provided at the opposite smaller sides of the adapter housing 110.
  • the container 300 also has a generally rectangular cross section in the horizonal and vertical planes.
  • alternative shapes are also encompassed by the present invention. For example, a square cross-section of the adapter 100 and/or the container 300 in horizontal and or vertical planes(s) is also envisaged.
  • the container 300 has an elliptical, semicircular, or even circular cross section in the horizontal plane.
  • the cross section of the adapter 100 might be adapted to such cross section of the container 300, and so the adapter 100 in an alternative embodiment has a circular cross section in the horizontal plane.
  • three connecting elements 160 may be provided, spaced from each other by 120° around the vertical center axis, and operable by a user with three fingers.
  • 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 elements 160 are flexible elements providing a releasable connection to the container housing 320.
  • each flexible element is at its one end integral with the adapter housing 110 and the opposite flexible end comprises the locking feature 161.
  • the locking feature 161 is a ledge extending in a direction perpendicular to the plane defined by axis A and B and projecting along axis B.
  • the locking feature is a groove extending in a direction perpendicular to the plane defined by axis A and B and being recessed along axis B.
  • the locking feature 341 of the container 300 is a corresponding, mating groove or ledge.
  • Such mating locking features 161, 341 provide a releasable securing of the adapter 100 to the container 300 along the first axis A.
  • the locking features 161, 341 are shaped such that a sliding movement along the axis of the entry port 150 (i.e., perpendicular to axis A) is required to couple the adapter 100 to the container 300.
  • the connecting elements 160, 340 have a curved shape (curved around the first axis) or helical shape so that the adapter 10 is connected to the container 300 with a rotational movement over some degrees of rotation, bringing the connecting elements 160, 340 slidingly into engagement. With such a configuration the connecting elements 160 of the adapter 100 need not be flexible but can be formed as protrusions of the adapter housing 110.
  • Fig. 3 shows the medicament bag of the container 300 in fluid communication with the adapter 100 according the first embodiment of the present invention.
  • the container housing 320 is removed so that the medicament bag 310 can be seen.
  • Fig. 4 shows the medicament bag 310 of the container released from the adapter 100 according the first embodiment of the present invention.
  • the container housing 320 is also not shown, and the adapter 100 is shown in a disconnected state, for example prior to connecting it to the container 300 before filling the medicament bag 310, or after the filling has been completed.
  • the medicament bag 310 has a port 330 to which the adapter 100 is couplable at a corresponding coupling element.
  • the push rod assembly 147 is shown in its first, for example, initial position where the outer surface 141 is flush with the outer surface 111 of the adapter housing 110. Consequently, the push rod 140 further described below (not shown, as it is internally provided) is also in the first/initial position.
  • Fig. 5 shows the adapter 100 according to the first embodiment of the present invention.
  • the adapter 100 is shown in a state where push rod assembly 147 and thus the push rod 140 has already been operated by a user.
  • the push rod 140 has been displaced along the first axis towards the medicament bag (not shown).
  • the push rod 140 has been displaced downwards by pushing the push rod assembly 147 (negative A-axis direction). This may be done, e.g., via the outermost end surface 141.
  • This displacement may in some embodiments require a stepped structure of the adapter housing 110, which will be clearer below.
  • the housing 110 and the push rod assembly 147 may be provided with a snap-in connection locking the push rod assembly 147 in the pushed position.
  • the housing 110 may comprise recesses or cut-outs and one of the walls of the push rod assembly 147 may comprise corresponding protrusions engaging the recesses or cut-outs (see Fig. 6).
  • Fig. 6 shows an exploded perspective view of the adapter 100 according to the first embodiment of the present invention.
  • Fig. 6 shows the adapter housing 110 with the adapter connecting elements 160 with its ledges 161 and the entry port 150.
  • Fig. 6 also shows part of a cavity 120 of the adapter housing 110, which cavity 120 is open towards a cavity opening 121 for fluid communication with the medicament bag 310.
  • Fig. 6 also shows the push rod assembly 147 in more detail.
  • the push rod assembly 147 may comprise the push rod 140, outermost end surface 141, side element 142, recess 143, O-ring 144, O-ring 145 and gasket 146.
  • the push rod assembly 147 may also be referred to as a (push) button.
  • a closure element 130 may be provided releasably provided in the cavity 120 as described below or may be releasably provided on an end surface of the push rod 140 (in the negative A-axis direction).
  • the push rod 140 may be provided internally of the push rod assembly 147 as shown in Fig. 6.
  • the push rod 140 may protrude in the A-axis (first axis A) direction.
  • the push rod 140 may protrude in the negative A-axis direction from the lower side of the outermost end surface 141.
  • the push rod 140 may protrude towards the container 300.
  • the push rod 140 is at least partially arranged outside the cavity 120 and is movable by a user in a direction along the first axis A for displacing the closure element 130 within the cavity 120.
  • the push rod 140 may be movable via operation of the push rod assembly 147, e.g., the outermost end surface 141.
  • Fig. 1 The wording "at least partially arranged outside the cavity” refers to a state shown in Fig. 1, for example, where the push rod 140 (not shown) is in its initial position. Upon moving it towards the medicament bag to reach a state as shown in Fig. 5, the push rod 140 is moved into the cavity 120 to displace the closure element 130.
  • Fig. 6 further shows O-rings 144, 145, and gasket 146.
  • the O-rings 144, 145 are located on push rod 140 and cooperate with an inner surface of the cavity 120 to provide a fluid tight seal. This helps to ensure that the pharmaceutical composition is expelled from the cavity 120 as the medicament container 300 is closed.
  • the gasket 146 is located between the adapter 100 and the container 300 and helps to ensure a fluid tight seal between the adapter 100 and the port 330 of the container 300.
  • a feedback mechanism may be provided.
  • the feedback mechanism may be triggered after the closure element 130 has been correctly positioned to seal the medicament bag 310 and provide an audible and/or tactile and/or visual feedback to the patient when the push rod 140 is pushed beyond the final closure element 130 position.
  • the mechanism may ensure that the adapter 100 is not prematurely released from the container 300.
  • the push rod 140 may be subdivided in an inner rod 1401 and a sleeve 1402.
  • the sleeve 1402 may be slidably provided surrounding the inner rod 1401.
  • a spring 1403 may be provided biasing the sleeve 1402 downwards, i.e., towards the port element 330 (A- axis direction).
  • the inner rod 1401 may protrude along the first axis (A-axis).
  • the inner rod 1401 may protrude from a lower side of the outermost end surface 141 of the push rod assembly 147.
  • the sleeve 1402 may be formed as a substantially hollow cylindrical body.
  • the sleeve 1402 may be configured to coaxially slide with respect to the inner rod 1401.
  • An abutment, stopper, collar or the like may limit the maximum extension of the sleeve 1402 with respect to the inner rod 1401.
  • the lower end of the sleeve 1402 i.e., the end directed towards the container 300, may be configured to releasably seat the closure element 130.
  • the sleeve 1402 may be configured for displacing the closure element 130.
  • the spring 1403 may be configured such that the force of the spring 1403 is greater than a friction between the closure element 130 and the cavity 120. Hence, when the push rod assembly 147 (button) is actuated, the spring 1403 is not or only slightly compressed enabling the closure element 130 to be moved from the first position to the second position to seal the medicament bag 310.
  • the following description may particularly be combined with the embodiment shown in Figs. 1 to 11. Unless indicated otherwise, the configurations of Figs. 1 to 16 are compatible with each other.
  • Fig. 12A shows an adapter 100 attached to a container 300 as described above.
  • the adapter 100 is releasably fixated to the container 300 by interaction of the adapter connecting elements 160 and the container connecting elements 340.
  • the closure element 130 is in its first position and may be provided at an end of the sleeve 1402.
  • the push rod assembly 147 is actuated, as shown in Fig. 12B, the push rod 140 consisting of the inner rod 1401 and the sleeve 1402 biased downwards by the force of the spring 1403, pushes the closure element 130 towards the medicament bag 310 until the port element 330 is closed as described above (closing position of the push rod assembly 147).
  • the mechanical interaction may be a pushing movement, sliding movement, deflecting movement, twisting movement, or the like. Said mechanical interaction may also produce an audible and/or tactile feedback signal ("click").
  • the adapter connecting elements 160 may be provided within the housing 110 (internally, as opposed to Figs. 1 to 11) such that they cannot be reached by a user (pharmacist or patient) and an unintentional release of the adapter 100 from the container 300 is prevented.
  • the adapter connecting elements 160 may be provided at inner walls of the housing 110. They may be structurally similar to the adapter connecting elements 160 described above.
  • the adapter 100 may also be connected to the container 300 via a twist-lock. Opposing cam surfaces of the adapter connecting elements 160 and a release mechanism of the push rod assembly 147 may turn the twist-lock between the adductor 100 and the container 300, thus releasing the adapter 100 from the container 300.
  • the outer side walls of the housing 110 may themselves from the adapter connecting elements 160 with locking features 161 protruding to the inside.
  • elongated sidewalls of the push rod assembly 147 may mechanically interact with the adapter connecting elements 160 releasing them from the corresponding container connecting elements 340.
  • the adapter connecting elements 160 may be tapered towards the container connecting elements 340 such that the push rod assembly 147, when moved downwards as indicated by the arrow, biases the adapter connecting elements 160 outwards and causes them to deflect, thereby releasing engagement with the container connecting elements 340.
  • the orientation of the adapter locking features 161 and the corresponding container locking features 341 is not limited to the above-described configuration.
  • the releasable connection between the adapter 100 and the container 300 may be achieved by a cantilevered or hinged snap.
  • the downward movement of the push rod assembly 147 may translate into a rotational movement of the adapter locking features 161 to release the adapter 100 from the container 300.
  • the push rod assembly 147 may remain in the pushed position after the above described mechanical interaction. This may be achieved, e.g., by corresponding ledgers and protrusions locking the push rod assembly 147 in the releasing position. In that manner, a visual indication of sealing the medicament bag 310 may be provided as shown in, e.g., Fig. 5.
  • filling of a cassette 300 may be performed as follows.
  • a user connects a syringe 400 to the entry port 150.
  • Locking tabs (adapter connecting elements 160), which may be hidden, hold the adapter 100 at the cassette 300 without any (exposed) touch points where a user could grip the adapter 100 and accidentally remove it.
  • 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 compression force that is strongerthan the force required to slide and seat the closure element 130 in the second position.
  • the push rod assembly 147 (button), that is, the rod 1401, sleeve 1402 and spring 1403, slides together until the closure element 130 reaches its second position (sealing position).
  • the spring 1403 compresses allowing the push rod assembly 147 (button) to continue travelling down the adapter housing 110.
  • the button 147 contacts the locking tabs (adapter connecting elements 160) and releases their connection to the cassette connecting elements 340 through a mechanical interaction as described above.
  • This mechanical interaction also produces an audible and/or tactile feedback signal ("click") indicating to a user that the pressing action and closing of the medicament bag 310 is complete. Consequently, the adapter 100 can be removed from the cassette 300.
  • the push rod assembly 147 of this exemplary embodiment has generally a T- shape.
  • the vertical part of the T being formed by a generally cylindrical part (inter alia, the push rod 140), and the horizontal part being formed by a substantially flat plate forming the outer surface 141.
  • the push rod 140 may have opposing side elements 142 extending parallel to the central vertical part or stem so that the space formed by the push rod 140 is closed and guided by the adapter housing 110.
  • one side element may have a recess 143 the shape of which is mating with the shape of the entry port 150 so that upon movement of the push rod 140 there is no conflict with the entry port 150.
  • the push rod assembly 147 may also be formed as a substantially cylindrical body and oval-shaped elongated member or the like. Further, the housing 110 may have a T-shape or a curved shape having gripping areas/features.
  • Fig. 6 also shows the stepped structure of the adapter housing 110.
  • the stepped structure is generally a U-shaped structure.
  • the stepped structure allows for a displacement of the push rod 140 from an initially flush position (as sown in Fig. 1) to the position shown in Fig. 5.
  • the flush configuration is a design option, and the push rod 140 can likewise protrude upwards from the surface 111 of the adapter housing 110.
  • no stepped structure of the adapter housing 110 is necessary, i.e., the upper surface 111 of the adapter housing is contiguous.
  • Fig. 6 shows a valve element 170, for example, a swabable valve, for attaching or connecting or coupling a syringe, for example a needle-free syringe.
  • a valve element 170 for example, a swabable valve, for attaching or connecting or coupling a syringe, for example a needle-free syringe.
  • Fig. 7 shows a perspective bottom view of the housing 110 of the adapter 100 according to the first embodiment of the present invention.
  • the cavity 120 and its arrangement relative to the entry port 150 is clearly seen.
  • Fig. 8 shows a different exploded perspective view of the adapter 100 according to the first embodiment of the present invention.
  • the entry port opening 151 is seen.
  • the entry port 150 is in fluidic communication with the cavity 120 of the adapter housing 110.
  • Fig. 9 shows a perspective top view of the housing of the adapter 100 according to the first embodiment of the present invention. Again, the cylindrical cavity 120 is illustrated in this drawing, and the entry port 150.
  • Fig. 10 shows a perspective cross-sectional view of the housing 110 of the adapter 100 according to the first embodiment of the present invention.
  • the cross section is drawn in the plane formed by the first axis A and a third axis being perpendicular to the first axis A and the second axis B.
  • This cross-sectional view shows the entry port 150 with its entry port channel 152 and the entry port opening 151.
  • the axis of the entry port channel 152 is perpendicular to the axis of the cavity 120.
  • the opening 151 enters into the cavity 120 at a location along first axis A that is between the closure element 130 in its first, for example initial, position, and the cavity opening 121.
  • the opening 151 is located axially between the first position of the closure element 130 and the cavity opening 121 when viewed along the first axis A.
  • the axial position of the opening 151 is preferably such that the closure element 130 when being in its initial position does not overlap with the opening 151, and that the closure element 130 in its final position does also not overlap with the opening 151.
  • partial overlap in one or both of these positions of the closure element 130 with the opening 151 is encompassed by the present disclosure.
  • the cavity 120 has a portion of slightly larger diameter towards the cavity opening 121. This facilitates mating with the port 330 of the medicament bag 310.
  • the cavity 120 also has a portion of slightly larger diameter towards the other end, e.g. the end opposite to that of the cavity opening 121, and on a side of the entry port 150 that is away from the cavity opening. This helps to keep the closure element 130 in place before using the adapter 100.
  • Fig. 11 shows a perspective view of a different cross-section of the housing of the adapter according to the first embodiment of the present invention.
  • This cross section is drawn in a plane formed by the first axis A and the second axis B.
  • the opening 151 connecting the entry port channel 152 with the cavity is seen, and also the cavity opening 121.
  • an accidental closure prevention mechanism may be provided.
  • a protective element 148 hindering the actuation of the push rod assembly 147 and thus the push rod 140 may be provided.
  • the protective element 148 may be, e.g., a cap covering the push rod assembly 147 as shown in Fig. 13A. As long as the cap 148 is attached to the adapter 100, the push rod assembly 147 cannot be actuated.
  • the cap 148 may sit on an upper shoulder of the housing 110.
  • the cap 148 may be attached to the housing 110 by a form fit feature, e.g., a snap fit, or friction. Gripping features may be provided to facilitate removal of the protective element 148.
  • the protective element 148 may be provided as a bracket between the push rod assembly 147 in the initial position and the housing 100 as shown in Fig. 13B.
  • the bracket 148 may physically obstruct activation of the push rod assembly 147 until removed.
  • the bracket 148 may be provided in a substantial U-shape.
  • the bracket 148 may be supported by an upper shoulder of the housing 110 and a lower surface of the outermost end surface 141.
  • the push rod assembly 147 may have an outer appearance in a T-shape or may have recesses or cutouts allowing the bracket 148 to fit between the housing 110 and the push rod assembly 147.
  • Fig. 13C shows a further configuration of the protective element 148, where the protective element may be provided as a protrusion to be gripped by the user and pulled from a slot, revealing the push rod (see left drawing of Fig. 13C).
  • a protrusion 148 may contain indicators such as arrows or textured features to encourage gripping and make removal obvious to the user (see right drawing of Fig. 13C).
  • a blocking member 1491 may be provided blocking movement of the push rod assembly 147 and thus the push rod 140 along the A-axis direction until the blocking member 1491 is removed.
  • the push rod assembly 147 may comprise a receiving recess 1492, e.g., a slit or a hole, configured to receive the blocking member 1491.
  • the receiving recess 1492 may be provided in a third axis direction (C-axis) perpendicular to the first axis (A-axis) and optionally also perpendicular to the second axis (B- axis).
  • C-axis third axis direction
  • the blocking member 1491 protrudes in the third axis direction and abuts a shoulder of the housing 100. Thereby, actuation of the push rod assembly 147 is prevented.
  • the push rod assembly 147 can be actuated to move the closure element 130 from the first position to the second position.
  • the blocking member 1491 can be formed as an elongated member (e.g., a pin), may have a U-shape or a substantial O-shape as shown in Fig. 14A. It may also be formed as a plate-like member.
  • the receiving recess 1492 may be formed in correspondence to the blocking member 1491. In the blocking position, the blocking member 1491 may at least partially protrude from the receiving recess 1492 such that removal by a user is facilitated. That is, the receiving recess 1492 may be formed to be shorter than a length of the blocking member 1491.
  • the receiving recess 1492 for receiving the blocking member 1491 may be formed in one side element 142 or both side elements 142.
  • the receiving recess 1492 may be provided at at least 1 of the lateral sides thereof (recessed in the second and/or third axis direction, B-/C-axis).
  • Fig. 14B shows a further possibility of preventing inadvertent actuation of the push rod assembly 147, where the blocking member 1491 is formed as an elongated member located parallel to the push rod assembly 147.
  • the push rod assembly 147 may be recessed to allow a user's finger to be placed between the elongated member 1491 and the push rod assembly 147, i.e., inside the cavity (see top drawing of Fig. 14B).
  • the elongated member 1491 may be removed at an angle perpendicular to the filling port 150 without obstructing the opposite side of the filling port 150, allowing access to the elongated member 1491 while the filling tool is lying flat (e.g., on the surface of a compounding hood) with the filling port 150 facing up (see bottom middle and right drawings of Fig. 14B.
  • the shape of the elongated member 1491 may also be designed to indicate to the user which direction to pull to remove it (e.g., an arrow shape as in the bottom left drawing of Fig. 14B).
  • the elongated member 1491 may be connected to the push rod assembly 147 or the housing 110 via a breaking point. Moreover, the elongated member 1491 may be configured to either physically obstruct travel of the push rod assembly 147, when still in place, or hinder a user to comfortably reach and actuate the push rod assembly 147.
  • the elongated member 1491 may have a U-shape and may be received in slots of the protective member 148.
  • the protective member 148 may also serve as a push button and may thus be provided with a push rod 140.
  • the protective member 148 may have a smaller extension in the B-axis direction (side and back walls) allowing downward movement, i.e., actuation, of the protective member 148 having the push rod 140 to move the closure element 130 to seal the medicament bag 310.
  • the adapter housing 110 may also have a smaller height. In the initial state, a gap between an upper surface of the adapter housing 110 and an inner surface of the protective element 148 may be present which is closed when the protective element 148 is moved downwards.
  • the protective element 148 may be subdivided into a push button portion having the push rod 140 (i.e., at a centre portion of the protective element 148) which is moveable independent from the protective element 148.
  • Fig. 14D is a cross sectional view of Fig. 14C showing the inserted elongated member 1491 in a blocking position.
  • the elongated member 1491 may sit, when inserted, on an upwardly directed surface 1101 of the adapter housing 110 (see also Fig. 15H) and may be provided with blocking protrusions or shoulders 1493 configured to abut an inner surface of the protective member 148 (or push rod assembly 147). Hence, movement of the protective member 148 (or the push rod assembly 147) and thus movement of the closure element 130 is blocked.
  • the shoulders 1493 may protrude, as shown in Fig. 14D, in the B-axis direction, or in the A- axis direction.
  • the elongated member 1491 In order to remove the elongated member 1491, it may be squeezed. That is, the two legs of the elongated member 1491 may be pushed towards each other (to the inside). Thereby, the abutment of the shoulders 1493 on the protective member 148 is released and the elongated member 1491 can be removed from the protective member 148 by pulling it upwards (A-axis direction).
  • the slots have a width sufficient for allowing the shoulders 1493 to pass, when the elongated member 1491 is pushed together.
  • the above described mechanism for preventing accidental closure of the medicament bag 310 can also be used without the protective member 148 by providing slots for inserting the elongated member 1491 in the push rod assembly 147, in particular in the outermost end surface 141.
  • an inner surface of the push rod assembly 147 sits on the shoulders 1493 as previously explained, thus blocking downward movement of the push rod assembly 147.
  • a locking interaction of the syringe 400 and the adapter 100 may also be used to prevent placing the closure element 130 during syringe 400 connection and dispense.
  • a protective element 148 e.g., a cap, may be placed over the push rod assembly 147.
  • the locking mechanism may be formed as, e.g., a pin engaging the protective element 148 when a syringe 400 is attached to the adapter 100.
  • the pin may be moved together with the turning movement of the syringe 400 to engage a corresponding groove or recess at the protective element 148. Consequently, when the syringe 400 is unscrewed, i.e., the syringe 400 is removed, the pin is also turned back, thus releasing the protective element 148. Also, a latch or the like may lock removal of the protective element 148 as long as the syringe 400 is attached to the adapter 100.
  • the pin or latch described above may be provided inside the housing 110.
  • the push rod assembly 147 may also contain an external feature (e.g., protrusion or groove) that obstructs travel of the push rod to the necessary position to close the medicament bag 310 when a syringe 400 is attached to the filling tool port.
  • an external feature e.g., protrusion or groove
  • the push rod assembly 147 can be actuated to close the medicament bag 310.
  • the locking mechanism can be formed as, e.g., a nose protruding from the push rod assembly 147/button 147 in the third axis direction (to the right in Fig. 15) which sits on the syringe 400 and thus prevents pushing the push rod assembly 147 downwards as long as the syringe 400 is connected to the adapter 100.
  • closure element mechanism described above can only be actuated once the syringe 400 is removed from the adapter 100.
  • Figs. 15F to 15H show further embodiments of an adapter 100 comprising a protective element 148.
  • the protective element 148 may be formed as a cover covering exposed sides of the housing 110. That is, a shape of the protective element 148 may substantially follow the shape of the housing 110.
  • the protective element 148 may cover all sides except the one at which a container 300 can be attached.
  • the protective element 148 may be formed as a substantially box-shaped member.
  • the boxshaped member 148 may have no bottom wall (i.e., the wall in the negative A-axis direction, towards the container 300) such that it can be placed over the housing 110 (Fig. 15F).
  • a side wall of the box-shaped member 148 corresponding to the side of the entry port 150 on the housing 110 may be formed as a flap 1481.
  • the flap 1481 may be pivotable around the B-axis.
  • the flap 1481 may be hingedly coupled to an upper wall of the box-shaped member 148 (i.e., 1 the uppermost wall in the positive A-axis direction, distant from the container 300).
  • the flap 1481 may further comprise a port cut-out 1482 at a position corresponding to the entry port 150 and allowing access thereto.
  • the syringe 400 is attached to the adapter 100 via the entry port 150 with the box-shaped member 148 placed over the housing 110 as shown in Fig. 15F.
  • the syringe 400 When the syringe 400 is placed in the port cut-out 1482, it blocks upward removal of the box-shaped member 148.
  • the flap 1481 cannot be pivoted upwards due to the syringe 400. Access to the push rod assembly 147 (button) is therefore blocked and the medicament bag 310 can thus not be accidentally and prematurely sealed by the closure element 130.
  • access to the adapter connecting elements 160 is blocked and removal of the adapter 100 from the container 300 is prevented.
  • the syringe 400 is removed from the entry port 150.
  • upward removal of the box-shaped member 148 may still not be possible.
  • the flap 1481 may be pivoted upwards as shown in Fig. 15G. In that manner, the box-shaped member 148 can be removed from the housing 100 to allow a user to actuate the push rod assembly 147 and the adapter connecting elements 160.
  • the movement of the flap 1481 may actuate the push rod assembly 147 to move the closure element 130 from the first position to the second position.
  • a protrusion protruding towards the housing 110 may be provided and configured to translate the pivoting movement to a downward movement of the push rod assembly 147.
  • a handle 180 (e.g., an arched bracket) may be formed at the housing 110 as shown in Fig. 16A.
  • the handle 180 may protect the push rod assembly 147 from being accidentally activated.
  • a user enters the handle 180 with a finger and pushes down the push rod assembly 147 as described above.
  • the housing 110 may be shaped such that the user is biased to grip the adapter 100 at a particular and predefined position to prevent accidentally actuating a release mechanism before the closure element 130 is correctly placed.
  • the housing 110 may have gripping areas inwardly recessed (B-axis direction) from an outer surface of the housing 110 with respect to the adapter connecting elements 160.
  • gripping areas may for example be formed as a neck or a narrow part on at least one, preferably two, lateral side(s) of the housing 110 (B-axis direction).
  • the housing 110 may be formed slimmer/narrower at a centre portion than at the top and/or the bottom (wherein the bottom portion refers to an end portion towards the adapter connecting elements 160/towards the container 300).
  • the gripping areas encourage the user to hold the adapter 100 in a location away from the adapter connecting elements 160 (release tabs).
  • a sliding cover 190 may be provided at the adapter 100.
  • the sliding cover 190 may be movable along the first axis direction (A-axis). It may be movable to selectively cover or reveal the release feature (in particular, the connecting elements 160).
  • the sliding cover 190 may partially or fully surround the housing 110. Also, the sliding cover 190 may be guided in the first axis direction (A-axis) in slots provided at the lateral sides of the housing 110.
  • the sliding cover 190 may be connected to the housing 110 in such a manner that the friction between the two elements is sufficient to hold the sliding cover 190 in place.
  • the sliding cover 190 may be biased downwards, i.e., towards the container 300, to hinder or block access to the adapter connecting elements 160.
  • a spring may be provided between the housing 110 and the sliding cover 190, pushing the sliding cover 190 towards the container 300.
  • Fig. 16C is a front view of an adapter 100 comprising a sliding cover 190 as described above.
  • Fig. 16D as a perspective review of a container 300 with an attached adapter 100 having a sliding cover 190.
  • Fig. 16D shows the sliding cover 190 in the upper position exposing the adapter connecting elements 160 for disconnecting the adapter 100 from the container 300 after the drug has been transferred into the medicament bag 310 as explained above.
  • the sliding cover 190 may substantially fully cover the adapter 100, apart from the entry port 150, in a locking position (left image). Moreover, lateral cutouts 191 may be provided. In the locking position, a user is able to attach a syringe 400 to the entry port 150 but cannot reach any actuating members through the lateral cut-outs 191. In turn, the sliding cover 190 is blocked from being moved downwards by the attached syringe 400. After transfer of the drug, the syringe 400 can be removed from the adapter 100 and the sliding cover 190 may be pushed downwards into a releasing position.
  • This downward movement may additionally actuate the push rod assembly 147 for moving the closure element 130 from the first position to the second position.
  • the adapter connecting elements 160 are exposed for removing the adapter 100 from the container 300.
  • the sliding cover 190 may also comprise inner protrusions pushing and releasing the adapter connecting elements 160 when the sliding cover 190 is moved in the releasing position. In that case, the cut-outs 191 may be omitted.
  • the sliding cover 190 may be slidably connected to the housing 110 by a groove and tongue connection.
  • the housing 110 may comprise a guiding slot at an outer surface and the sliding cover 190 may comprise a corresponding protrusion at an inner surface thereof (or vice versa), allowing the sliding cover 190 to be moved in the first axis direction.
  • a procedure is as follows.
  • a user fills the medicament bag 310 through the adapter 100 as explained above and moves the closure element 130 by actuation of the push rod assembly 147.
  • the closure element 130 may be moved together with the sliding cover 190.
  • the sliding cover 190 is moved by the user, exposing the adapter connecting elements 160 and allowing the adapter 100 to be disconnected from the container 300. In that manner, an accidental removal of the adapter 100 from the container 300 during drug transfer or before sealing of the medicament bag 310 can be prevented.
  • Fig. 16E it is shown that the sliding cover 190 extends beyond the lowest point of the adapter 100 and thus reaches over the container 300. This feature can be applied to all embodiments described above.
  • tongues or legs 192 may be provided to reduce the rotational and tilting degrees of freedom of the adapter 100 with respect to the container 300.
  • the legs 192 may protrude from the housing 110 in a direction along the first axis A (negative A-axis direction).
  • the legs 192 may contact an outer surface of the container 300, if attached.
  • the adapter housing 110 shown in Figs. 1 or 2 may have at least two, preferably four, legs, tongues, or protrusions 192 extending downwards and over the container 300.
  • the legs 192 may be provided on both a front and a rear side (in the C-axis direction) of the adapter housing 110.
  • the legs, tongues or protrusions 192 may also reduce a degree of tilt of the adapter 100 with respect to the container 300.
  • a length of the legs 192 may be chosen according to the desired stability.
  • Fig. 17 shows a cross-section of an adapter 500 according to a second embodiment of the present invention.
  • the adapter 500 has a different configuration.
  • the adapter 500 of this embodiment has a housing 510 that is generally elongate, and in this preferred embodiment at least is generally cylindrical in shape.
  • the housing 510 defines a cavity 520 that has a cavity opening 521 at the end facing the medicament bag 310 or the medicament container 300, respectively, when the adapter 500 is in use.
  • the housing 510 has a structure for mounting the adapter 500 to the container 300.
  • the adapter 500 is shown coupled to the port 330 of the medicament bag 310 in the container 300.
  • a closure element 530 is located in the cavity 520.
  • a push rod 540 (also referred to as a push rod assembly 540), which may be T-shaped in cross section, is shown at least partially arranged outside the cavity 520 (and at least partially within the cavity 520) and is movable by a user in a direction along the first axis A for displacing the closure element 530 within the cavity 520.
  • the housing 510 has wings 560 for being gripped by a user during use of the adapter 500.
  • the housing 510 has an entry port 550 with an entry port opening 551 and an entry port channel 552.
  • the entry port channel 552 is closed with a septum 555.
  • the entry port channel 552 is shown inclined with regard to the first axis A.
  • at least part of the length of entry port channel 552 is inclined with respect to the first axis A (or the second axis B).
  • the axis of at least part of the length of entry port channel 552 lies in the plane defined by axes A and B.
  • the axis of at least part of the length of entry port channel 552 may further be inclined with regard to the plane defined by axes A and B.
  • the entry port channel 552 may also be oriented perpendicular to the first axis A, like it is shown in the first embodiment, i.e., along the second axis B.
  • the entry port channel 552 may be oriented perpendicular to the first axis A and also inclined with respect to the plane defined by axes A and B.
  • the opening 551 enters into the cavity 520 at a location along first axis A that is between the closure element 530 in its first, for example initial, position, and the cavity opening 521 .
  • the opening 551 is located axially between the first position of the closure element 530 and the cavity opening 521 when viewed along the first axis A.
  • the axial position of the opening 551 is preferably such that the closure element 530 when being in its initial position does not overlap with the opening 551, and that the closure element 530 in its final position does also not overlap with the opening 551.
  • partial overlap in one or both of these positions of the closure element 530 with the opening 551 is encompassed by the present disclosure.
  • the container 300 is (pre- )assembled with the adapter 500 for the pharmacy or clinic filling scenario.
  • This assembly can be packed as a single piece.
  • the adapter 500 contains the closure 530 which is needed to close the system.
  • the design of adapter 500 is like a syringe, but instead of a plunger in a syringe the closure element 530 in the adapter 500 is moved by the push rod 540 inside the cavity 520.
  • a connection to the adapter cavity 520 by the entry port 550 allows the filling of the drug container 300.
  • Fig. 17 shows a septum 555 which can be pierced with a cannula multiple time.
  • the septum 555 is arranged in the entry port channel 552 as a closure of the entry port 550 at the end opposite to the entry port opening 551.
  • a Luer connection or both, other non-Luer connections, or other suitable connectors may be provided for a closed-system transfer device (CSTD) or components thereof to avoid user exposure to a medication filled into the drug container using the apparatus.
  • CSTD closed-system transfer device
  • Fig. 18 illustrates the use of the adapter 500 of the second embodiment of the present invention.
  • the left-hand figure shows the (pre-)assembled adapter 500 and drug container 300.
  • the next stage of use is shown in the right-hand figure. It illustrates how the septum 555 is pierced by the filling syringe, and the medicament is transferred via the cavity 520 and through the cavity opening 521 into the medicament container 300 (medicament flow highlighted by the two arrows).
  • the syringe is removed, as by withdrawal, unscrewing, etc. If needed, one or more further components can be inserted this way into the container 300. Thus, this process may be repeated any number of times if necessary.
  • Fig. 19 illustrates further steps of the use of the adapter 500 of the second embodiment of the present invention.
  • Fig. 19 shows the stoppering and the removal of the adapter 500 from the drug container. When all drug components are in the drug container 300, the push rod 540 of the adapter 500 is pressed.
  • the closure element 530 acts as a plunger and pushes all drug elements remaining in the cavity 520 into the drug container 300.
  • the user may push with the thumb on the push rod 540 and concurrently holds the two wings 560 with index finger and middle finger to apply a force on the push rod 540 (see left-hand figure).
  • the closure element 530 is connected to the port, it for example snaps in, and seals and closes the drug container 300.
  • the push rod 540 of the adapter (right-hand figure) until the push rod 540 contacts the housing 510, the connection between the closure element 530 and the adapter 500 releases and the adapter 500 can be removed from the drug container 300 and discarded.
  • the closure element 530 is now arranged on the drug container 300.
  • the right-hand figure shows that the adapter housing 510 is already lifted a certain distance from the drug container 300.
  • the push rod 540 may comprise feedback means indicating that the closure of the medicament bag 310 has been completed.
  • Figs. 20 to 22 show the container 300 according to an aspect of the present invention in more detail.
  • the container 300 is adapted to accommodate the medicament bag 310.
  • the medicament bag 310 is flexible.
  • the medicament bag 310 has an inner space to accommodate a volume of liquid.
  • the container 300 comprises a container housing 320 for accommodating the flexible bag 310, and in the illustrated embodiment supporting the medicament bag 310.
  • the container 300 also has an entry port (or outlet port, respectively) 343 for accommodating or receiving the port 330 of the medicament bag 310 for communication of the inner space of the medicament bag 310 with the exterior of the container 300.
  • the inlet port 343 is formed as a through hole.
  • the container 300 has a container housing case or container frame 322 and a container housing lid 321.
  • the lid 321 When the lid 321 is connected to the case or frame 322, the inner space for the medicament bag 310 is provided.
  • the lid 321 is a preferred element, the container 300 could accommodate the flexible bag 310 without being closed by lid 321.
  • the container housing lid 321 and the container housing case 322 each have a perimeter wall 323, 324.
  • the perimeter walls 323, 324 provide rigidity to the container housing 320.
  • the container 300 also has one or more container connecting elements 340.
  • the connecting elements 340 are adapted to mate with corresponding connecting elements of a flexible bag filling adapter, such as the adapter 100,500 of the present disclosure.
  • two connecting elements 340 are provided. These are preferably arranged one on each side of the inlet port 343.
  • each container connecting element 340 comprises a locking feature 341.
  • the one or more container locking features 341 comprise a case locking feature 3411 and a lid locking feature 3412.
  • the adapter 100, 500 is coupled or connected to the container housing case 322 and the container housing lid 321.
  • This allows for a coupling direction along the axis of the port 343.
  • the locking features 3411 and 3412 on the lid and on the case provide for a snap-on connection of the adapter on the container 300.
  • the locking feature is provided only in the container housing case 322 and not in the container housing lid 321. With such a configuration the adapter 100, 500 can be coupled to the container 300 for example in a sliding movement perpendicular to the axis of the port 343.
  • the container connecting element 340 is formed as a recess in the circumferential walls 323, 324 of the container housing case 322 and the container housing lid 321.
  • the respective locking feature 341 is preferably formed as a ridge or ledge at the wall of the recess. The ridge or ledge can mate with a corresponding ledge on the adapter connecting element to releasably couple the two components together.
  • the adapter 100, 500, adapter housing 110, 510, and push rod 140, 540 may be constructed of one or more rigid plastic materials, such as polypropylene, polycarbonate, acrylonitrile butadiene styrene, polyamide, polystyrene, or combinations thereof.
  • portions of adapter housing 110, 510, and push rod 140, 540 may be over-molded on the side closest to the container 300 body with a soft, compliant material, such as thermoplastic elastomer or thermoplastic polyurethane, to improve comfort for a user of the device during filling of the container 300 or placement of the closure element 130, 530.
  • the present disclosure also relates to a system comprising the adapter 100, 500 and the cassette 300 described above, i.e., a combination of the adapter 100, 500 and the cassette 300.
  • the devices described herein can be used for the treatment and/or prophylaxis of one or more of many different types of disorders.
  • Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), hypercholesterolaemia and/or dyslipidemia, cardiovascular disease, diabetes (e.g.
  • psoriasis psoriatic arthritis
  • spondyloarthritis spondyloarthritis
  • hidradenitis suppurativa Sjogren's syndrome
  • migraine cluster headache
  • multiple sclerosis neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behcet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute
  • Exemplary types of drugs that could 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 therapies, radioisotopes and/or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.
  • Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
  • immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
  • Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism 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 polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Cl esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modul
  • Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-la, interferon beta-lb, peginterferon beta-la, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-
  • Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab- pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90- Yttrium-ibritum
  • Exemplary drugs that could be included in the delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the "innovator” or “branded” version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.
  • Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid.
  • adjuvant or neoadjuvant chemotherapy such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid.
  • Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.
  • Exemplary drugs that could be included in the delivery devices 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, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer's solution, Heparin Lock Flush solution, 100 U/mL Heparin Lock Flush Solution, or
  • compositions including, but not limited to, any drug described herein are also contemplated for use in the delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier.
  • Such formulations may include 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 include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.
  • Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen 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-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

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un adaptateur pour le remplissage et la fermeture ultérieure d'un contenant de composition pharmaceutique, l'adaptateur comprenant un logement présentant un premier axe, le logement comprenant une cavité dotée d'une ouverture pouvant être raccordée à un orifice du contenant ; un élément de fermeture agencé dans la cavité et pouvant être déplacé d'une première position à une seconde position, dans une direction le long du premier axe ; une tige de poussée étant au moins en partie agencée à l'extérieur de la cavité et pouvant être déplacée par un utilisateur dans une direction le long du premier axe pour déplacer l'élément de fermeture ; le logement comprenant un orifice d'entrée doté d'une ouverture d'orifice d'entrée en communication avec la cavité, au moins une partie de l'ouverture d'orifice d'entrée étant située axialement entre la première position de l'élément de fermeture et l'ouverture lorsqu'elle est observée le long du premier axe.
PCT/US2023/080899 2023-11-22 2023-11-22 Adaptateur pour le remplissage et la fermeture ultérieure d'un contenant de composition pharmaceutique, et contenant pourvu d'un adaptateur Pending WO2025111000A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2023/080899 WO2025111000A1 (fr) 2023-11-22 2023-11-22 Adaptateur pour le remplissage et la fermeture ultérieure d'un contenant de composition pharmaceutique, et contenant pourvu d'un adaptateur

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2023/080899 WO2025111000A1 (fr) 2023-11-22 2023-11-22 Adaptateur pour le remplissage et la fermeture ultérieure d'un contenant de composition pharmaceutique, et contenant pourvu d'un adaptateur

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WO2025111000A1 true WO2025111000A1 (fr) 2025-05-30

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5318015A (en) * 1992-09-03 1994-06-07 Sven Mansson Inhaler having ejector structure that provides primary and secondary atomization of an actuated dose of medicament
US20100137833A1 (en) * 2006-11-15 2010-06-03 Glynn Kenneth P Methodology for drug delivery device with sliding valve
US20210252269A1 (en) * 2003-10-30 2021-08-19 Simplivia Healthcare Ltd. Safety drug handling device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5318015A (en) * 1992-09-03 1994-06-07 Sven Mansson Inhaler having ejector structure that provides primary and secondary atomization of an actuated dose of medicament
US20210252269A1 (en) * 2003-10-30 2021-08-19 Simplivia Healthcare Ltd. Safety drug handling device
US20100137833A1 (en) * 2006-11-15 2010-06-03 Glynn Kenneth P Methodology for drug delivery device with sliding valve

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