Ampoule adapter and method of use

Abstract

Adapters for resealing an ampoule after it has been broken open and related methods are disclosed. The adapter may include a body portion configured to receive at least a portion of the ampoule, a proximal open end, and a distal open end. The adapter may further include one or more inner seal members disposed at least partially within the body portion and configured to sealingly engage an outer surface of the ampoule. Furthermore, at least when the adapter is in an assembled or functional state, the adapter may include a cap or end seal member which covers the distal open end of the body portion. The one or more inner seal members and the end seal member may be configured to at least partially define a sealed interior space in which an open end of the ampoule can be safely stored.

Description

AMPOULE ADAPTER AND METHOD OF USECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] Priority is claimed to United States Provisional Patent Application No. 63 / 611,486, filed December 18, 2023, the entire contents of which are hereby incorporated by reference herein.FIELD OF DISCLOSURE

[0002] The present disclosure generally relates to the storage of pharmaceuticals and chemicals, and, more particularly, ampoules for storing such substances.BACKGROUND

[0003] Ampoules are a common form of packaging used in the pharmaceutical and chemical industries to store and preserve various liquids, including, for example, drugs, vaccines, and chemical reagents. Ampoules are typically made of glass and hermetically sealed to protect their contents from air and contaminants. To open an ampoule, one must break or snap the ampoule at a designated point to create an opening. Once opened, the ampoule cannot be resealed absent substantial efforts such as melting and bending the glass, processes which may be impractical to perform in the settings where ampoules are typically used.

[0004] As a result, in many cases the contents of an ampoule must be used or transferred to another container very quickly once the ampoule has been broken open. Otherwise, the contents of the opened ampoule risk being contaminated or degraded by the surrounding environment and potentially rendered unusable. The limited ability to reseal an ampoule often leads to the waste of its contents, especially when the entire volume is not required at once.

[0005] To address one or one of the needs and challenges mentioned herein and other related needs and challenges, the present disclosure set forth advantageous devices and methods for resealing ampoules and other similar containers after they have been opened.SUMMARY

[0006] One aspect of the present disclosure provides an adapter for an ampoule. The adapter may include a body portion configured to receive at least a portion of the ampoule. The adapter may further include a first inner seal member disposed at least partially within the body portion and configured to sealingly engage the ampoule.

[0007] Another aspect of the present disclosure provides a method of resealing an ampoule after the ampoule has been opened. The method may include: (a) inserting an open end of the ampoule into a body portion of an adapter; and (b) sealingly engaging the ampoule with a first inner seal member disposed within the body portion of the adapter.

[0008] A further aspect of the present disclosure provides an ampoule assembly including an adapter and an ampoule. The adapter may include a body portion and a first inner seal member. At least a portion of the first inner seal member may be disposed within the body portion. The ampoule may include an outer surface, and the first inner seal member of the adapter may sealingly engage the outer surface of the ampoule.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the drawings may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some drawings are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly delineated in the corresponding written description. Also, none of the drawings is necessarily drawn to scale.

[0010] Fig. 1 is a side view of an embodiment of an ampoule in accordance with various embodiments.

[0011] Fig. 2 is a side view depicting the ampoule of Fig. 1 disposed within an adapter in an initial or pre-assembled state in accordance with various embodiments. The adapter in Fig. 2 is illustrated as being semi-transparent for illustrative purposes only.

[0012] Fig. 3 is cross-sectional view of the adapter in Fig. 2 taken along the longitudinal axis A. The ampoule is omitted in Fig. 3.

[0013] Fig. 4 is a perspective view of the adapter of Fig. 2 in an assembled or functional state in accordance with various embodiments.

[0014] Fig. 5 is cross-sectional view of the adapter in Fig. 4 taken along longitudinal axis A. The ampoule of Fig. 1, after having been broken open to access its contents and then disposed within the adapter for resealing, is also shown in crosssection in Fig. 5.DETAILED DESCRIPTION

[0015] The present disclosure generally pertains to resealing an ampoule after it has been broken open, so as to protect its contents from degradation potentially resulting from exposure to the external environment. Further to this goal, the present disclosure describes an adapter which fits over an opened ampoule and sealingly engages its outer surface to form a sealed interior space. By housing an open end of the ampoule within the sealed interior space, the adapter may help preserve the integrity of the ampoule’s contents by shielding them from external elements such as air and contaminants, and additionally, may extend the usability of the ampoule’s contents by maintaining a controlled internal environment. Furthermore, the adapter is designed to be compatible with a variety of ampoule sizes and shapes, offering a versatile and practical tool for multiple applications in, for example, the pharmaceutical, chemical, and medical fields. Moreover, the adapter or portion(s) thereof may be sized to emulate various dimension(s) of a standard vial. This aspect of the adapter may facilitate its integration into existing processes and equipment, including, for example, automated systems designed to handle standard vials. Accordingly, the embodiments of the adapter described herein provide the option of employing existing infrastructure for handling an ampoule prior to and / or after being broken open. These and other advantages will be apparent to one of ordinary skill in the art reviewing the present disclosure.

[0016] Fig. 1 illustrates an ampoule, designated as item 10, which serves as a non-limiting example of the type of ampoule which can be utilized with the embodiments of the adapter described herein. The ampoule 10 has a sealed interior space for containing and preserving a substance, typically a liquid but also potentially a solid or gas. The substance may be a drug, vaccine, chemical, sample, or any other substance for which preventing contamination prior to use is important or essential. In some embodiments, the ampoule 10 may be hermetically sealed so that its contents are not exposed to external elements such as air and contaminants during storage.

[0017] In some embodiments, the ampoule 10 may be made of a single, continuous or substantially continuous piece of material including, for example, glass or plastic. So configured, the ampoule 10 may eliminate or substantially eliminate the likelihood of external elements contaminating or degrading the substance within the ampoule 10. In other embodiments, the ampoule 10 may have a multi-piece construction, with the different pieces being sealed to each other to prevent the ingress of contaminants. The material(s) used to construct the ampoule 10 may be selected for its / their chemical inertness and / or ability to withstand various storage conditions without reacting with the contents of the ampoule 10 and / or degrading over time.

[0018] The ampoule 10 may have a hollow, elongated shape with a proximal end 14 and distal end 16. The proximal end 14 of the ampoule 10 may include a cylindrical or substantially cylindrical wall and may be closed off at its proximal-most end by a planar or substantially wall. The distal end 16 of the ampoule 10 may have diameter or width that is less than that of the proximal end 14 of the ampoule 10 and may be closed off at its distal-most end by a hemispherical or substantially hemi-spherical wall. The distal end 16 of the ampoule 10 may be configured to be broken or snapped off of, or otherwise permanently or semipermanently detached from, the proximal end 14 of the ampoule 10, manually by a person or by other means. Pursuant to this, the ampoule 10 may include a neck 18 which connects the distal end 16 to the proximal end 14 and which has a reduced wall strength as compared to the proximal end 14 and / or distal end 16. In some embodiments, this configuration may be achieved by etching a score line or forming a groove in the neck 18 such that the neck 18 has a reduced wall thickness as compared to theproximal end 14 and / or distal end 16 of the ampoule 10. Once the neck 18 is broken, the distal end 16 of the ampoule 10 may be removed from the proximal end 14, thereby creating an opening 20 (see Fig. 5) in the proximal end 14 of the ampoule 10.Subsequently, the contents of the ampoule 10 may be accessed and withdrawn through the opening 20, for example, by a needle of a syringe.

[0019] The dimensions of the ampoule 10, including its length, diameter, and volume capacity, can vary depending on its intended use. In some embodiments, a glass or plastic wall of the ampoule 10 may be clear or colored and can include labeling areas or markings, which can be etched, printed, or labeled with essential information such as, for example, contents, dosage, and expiration date.

[0020] In some embodiments, a volume of a liquid disposed in the ampoule 10 may be within a range between approximately (e.g., ±10%) 1 - 20 mL, or within a range between approximately (e.g., ±10%) 1 - 10 mL, or within a range between approximately (e.g., ±10%) 1 - 5 mL, or within a range between approximately (e.g., ±10%) 1 - 4 mL, or within a range between approximately (e.g., ±10%) 1 - 3 mL, or within a range between approximately (e.g., ±10%) 1 - 2 mL, or less than or equal to approximately (e.g., ±10%) 10 mL, or less than or equal to approximately (e.g., ±10%) 5 mL, or less than or equal to approximately (e.g., ±10%) 4 mL, or less than or equal to approximately (e.g., ±10%) 3 mL, or less than or equal to approximately (e.g., ±10%) 2 mL, or less than or equal to approximately (e.g., ±10%) 1 mL, or any other suitable volume.

[0021] Turning to Figs. 2-5, an embodiment of an adapter, identified with reference numeral 30, will now be described. Figs. 2 and 3 illustrate an initial or pre-assembled state of the adapter 30 where it is configured to be fit over the ampoule 10 prior to the ampoule 10 being opened to access its contents. Figs. 4 and 5 illustrate a functional or assembled state of the adapter 30 where it is configured to reseal the ampoule 10 after the ampoule 10 has been opened.

[0022] The adapter 30 may include a body portion 32 having a hollow, elongated shape configured to receive a portion of or the entirety of the ampoule 10. The body portion 32 may include a proximal open end 34, a distal open end 36, and a cylindrical or substantially cylindrical wall 38 extending therebetween. Accordingly, the body portion 32 generally may have a sleeve-like or tubular shape. Furthermore, the body portion 32 may have a longitudinal axis A about which the cylindrical wall 38 is centered or substantially centered. Inserting the ampoule 10 into the body portion 32 may involve moving the ampoule 10 in a distal direction along the longitudinal axis A, with the distal end 16 of the ampoule 10 initially being inserted through the proximal open end 34 of the ampoule 10. A length L of the body portion 32 may be parallel or substantially parallel to the longitudinal axis A. As seen in Fig. 2, the length L of the body portion 32 may be less than a length of the ampoule 10 such that the distal end 16 of the ampoule 16 protrudes out through the distal open end 36 of the adapter 30 in the initial or pre-assembled state.

[0023] The body portion 32 may be made of any suitable rigid and / or non-porous material or combination of material. In some embodiments, the body portion 32 may be made of any one or combination of the following: metal (e.g., stainless steel), plastic (e.g., polyethylene or polypropylene), and glass. In Fig. 2, the body portion 32 of the adapter 30 is shown as being semitransparent for illustrative purposes only.

[0024] The cylindrical wall 38 of adapter 30 may include a proximal portion 38a, a distal portion 38b, and a middle portion 38c. The middle portion 38c of the cylindrical wall 38 may be disposed in the axial direction between the proximal portion 38a and the distal portion 38b of the cylindrical wall 38. The distal portion 38b of the cylindrical wall 38 may include a flange 40 which protrudes radially outwardly of the rest of the distal portion 38b of the cylindrical wall 38. The flange 40 may extend, in a circumferential direction, partially or entirely around the distal open end 36 of the body portion 32. The flange 40 may define a distal end surface 42 of the body portion 32, and the distal end surface 42 may be perpendicular or otherwise non-paral lei to the longitudinal axis A and generally face in the distal direction. In some embodiments, the flange 40 may be omitted such the distal end surface 42 does not protrude radially outwardly of a portion of the cylindrical wall 38 located immediately adjacent thereto.

[0025] In some embodiments, at least the distal portion 38b of the cylindrical wall 38 may be dimensioned and / or shaped to emulate (e.g., match or substantially match) the dimensioning and / or shape of the distal end of a standard vial, including, forexample, a vial having a standard ISO 20 mm finish. This feature may render the adapter 30 compatible with standard stoppers and / or crimp rings, including, for example, standard 20 mm stoppers and / or standard 20 mm aluminum crimp rings. Furthermore, by emulating the dimensions and / or shape of a standard vial, the cylindrical wall 38 or a portion thereof may be compatible with automated systems that normally process standard vials, including, for example, vials having a standard ISO 20 mm finish.

[0026] In some embodiments, the inner and / or outer diameters of some or all of the proximal portion 38a, distal portion 38b, and middle portion 38c of the cylindrical wall 38 may differ from one another. In the embodiment illustrated in Figs. 2-5, the proximal portion 38a of the cylindrical wall 38 has an inner diameter ID1 and an outer diameter OD1, the distal portion 38b of the cylindrical wall 38 has an inner diameter ID2, the distal portion 38b of the cylindrical wall 38 excluding the flange 40 has an outer diameter OD2, the middle portion 38c has an inner diameter ID3 and an outer diameter OD3, and the flange 40 has an outer diameter OD4. The inner diameter ID2 may be less than the inner diameter ID3, which may be less than the inner diameter ID1. The outer diameter OD2 may be less than each of the outer diameters OD1, OD3, and OD4. The outer diameters OD1 and OD3 may be equal and each may be larger than the outer diameter OD4.

[0027] In some embodiments: the inner diameter ID1 may be equal to approximately (e.g., ±10%) 18.2 mm; the outer diameter OD1 may be equal to approximately (e.g., ±10%) 21.9 mm; the inner diameter ID2 may be equal to approximately (e.g., ±10%) 13.3 mm; the outer diameter OD2 may be equal to approximately (e.g., ±10%) 16.5 mm; the inner diameter ID3 may be equal to approximately (e.g., ±10%) 15.3 mm; the outer diameter OD3 may be equal to approximately (e.g., ±10%) 21.9 mm; and / or the outer diameter OD4 may be equal to approximately (e.g., ±10%) 19.9 mm.

[0028] The cylindrical wall 38 may include an inner surface 44 which generally faces in a radially inward direction. As shown in Fig. 3, the inner surface 44 may be parallel to the longitudinal axis A, except for: a first portion 44a that is disposed in the axial direction between the proximal portion 38a and the middle portion 38c of the cylindrical wall 38, and a second portion 44b that is disposed in the axial direction between the middle portion 38c and the distal portion 38b of the cylindrical wall 38. The first portion 44a and / or the second portion 44b of the inner surface 44 may be arranged at an angle relative to the longitudinal axis A, including, for example, an angle of approximately (e.g., ±10%) 45 degrees. The angling of the first portion 44a and / or the second portion 44b of the inner surface 44 may assist in guiding the ampoule 10 into a desired position within the adapter 30 when the ampoule 10 is inserted into the adapter 30.

[0029] One or more recesses may be formed in the inner surface 44 of the cylindrical wall 38 and each may be configured to receive a respective seal member for sealingly engaging an outer surface of the ampoule 10. As used herein, the term “recess” refers to any portion of a wall that is set back with respect to an adjacent portion of the wall and encompasses without limitation a groove, a slot, a depression, a channel, and the like. In the embodiment illustrated in Figs. 2-5, a first recess 46 and a second recess 48 are formed in the inner surface 44 of the middle portion 38c of the cylindrical wall 38 of the adapter 30. The first recess 46 and / or the second recess 48 may have an annular or ring-like shape and each may be configured to receive, as discussed in more detail below, a respective seal member such as an O-ring. The first recess 46 and the second recess 48 may each be centered around the longitudinal axis A and may be spaced apart from each other in the axial direction. In some embodiments, each of the recesses 46 and 48 may have a width extending in the axial direction equal to approximately (e.g., ±10%) 1.65 mm.

[0030] The adapter 30 may include one or more inner seal members disposed at least partially within the body portion 32 and configured to sealingly engage an outer surface (e.g., a radially outwardly facing surface) of the ampoule 10. The embodiment of the adapter 30 illustrated in Figs. 2-5 includes a first inner seal member 52 and a second inner seal member 54; however, alternative embodiments may include additional inner seal members or a single inner seal member. The first inner seal member 52 may be disposed at least partially in the first recess 46 and include a radially inwardly facing surface configured to sealingly engage a radially outwardly facing surface of the proximal end 14 of the ampoule 10. The second inner seal member 54 may be disposed at least partially in the second recess 48 and include a radially inwardly facing surface configured to sealingly engage a radially outwardly facing surface of the proximal end 14 of the ampoule 10. The first inner seal member 52 and / or the secondinner seal member 54 may form an air-tight or substantially air-tight and / or fluid-tight seal or substantially fluid-tight seal with the radially outwardly facing surface of the proximal end 14 of the ampoule 10. The first inner seal member 52 and / or the second inner seal member 54 may have an annular or ring-like shape. In some embodiments, the first inner seal member 52 and / or the second inner seal member 54 may be an O-ring or any other gasket made of an elastomeric material or any other material suitable for forming a seal with an outer surface of the ampoule 10.

[0031] In addition to providing a sealing function, the first inner seal member 52 and / or the second inner seal member 54 may frictionally engage the radially outwardly facing surface of the ampoule 10 to secure the ampoule 10 within the adapter 10, for example, to inhibit or prevent unintentional movement of the ampoule 10 along the longitudinal axis A with respect to the adapter 30. For example, the first inner seal member 52 and / or the second inner seal member 54 may slidably engage the radially outwardly facing surface of the ampoule 10 while ampoule 10 is being inserted into the adapter, but once the ampoule 10 reaches its intended or final position within the adapter 30, the friction between the first inner seal member 52 and the radially outwardly facing surface of the ampoule 10 and / or the friction between the second inner seal member 54 and the radially outwardly facing surface of the ampoule 10 may prevent unintentional movement of the ampoule 10 with respect to the adapter 30, including, for example, movement resulting from gravity pulling the ampoule 10 in a downward direction when the adapter 30 is lifted off of a resting surface such as a table. However, the first inner seal member 52 and / or the second inner seal member 54 may be configured such that the friction at the point of contact with the ampoule 10 is less than, for example, the pull force(s) which an average person is able to manually exert when attempting to remove the ampoule 10 from the adapter 30.

[0032] In alternative embodiments, one or more of the first inner seal member 52 and / or the second inner seal member 54 may be integrally formed with the cylindrical wall 38 of the body portion 32 of the adapter 30, such that the first inner seal member 52 and / or the second inner seal member 54 is / are not structure(s) which are separate from the cylindrical wall 38 of the body portion 32.

[0033] An opening or window 50 may be formed in the proximal portion 38a of the cylindrical wall 38, or any other portion of the cylindrical wall 38, to allow a user to view a lateral side of the ampoule 10 when the ampoule 10 is received in the adapter 30. The opening or window 50 may be distal to the proximal open end 34 of the body portion 32 and proximal to the distal open end 36 of the body portion 32. Additional similar such openings or windows may be formed in the cylindrical wall 30. Alternatively, the cylindrical wall 30 may be completely solid with no openings or windows for viewing the ampoule 10 laterally from the side.

[0034] In the initial or pre-assembled state, the distal open end 36 of the body portion 32 of the adapter 30 may be uncovered such that the distal end 16 of ampoule 10 extends outside of the adapter 30 as seen in Fig. 2. In other embodiments, the entirety of the ampoule 10 may be disposed within the adapter 30 in the initial or pre-assembled state. Storing the ampoule 10 within the adapter 30 prior to the ampoule 10 being broken open may be an optional feature. A potential benefit of storing the unopened ampoule 10 within the adapter 30 is that the adapter 30 may make the unopened ampoule 10 compatible for processing and / or handling by equipment, tools, automated systems, etc. designed for processing and / or handling standard vials.

[0035] In order to convert the adapter 30 from the initial or pre-assembled state (Figs. 2 and 3) into the functional or assemble state (Figs. 4 and 5), a cap or end seal member 60 may be secured to the flange 40 or another portion of the cylindrical wall 38 to cover the distal open end 36 of the body portion 32. This step may be performed at the point-of-use or point-of-care, including, for example, shortly before or after the ampoule 10 has been broken open by the user. Doing so may limit potential exposure of the end seal member 60 to contaminants in the surrounding environment in the time between when it is secured to the body portion 32 and when the opened ampoule 10 is inserted into the body portion 32.

[0036] The end seal member 60 may include a proximal end surface 60a configured to sealingly engage the distal end surface 42 of the cylindrical wall 38. As an example, the proximal end surface 60a of the end seal member 60 may form an air-tight or substantially air-tight and / or fluid-tight seal or substantially fluid-tight seal with the distal end surface 42 of the cylindrical wall 38.As such, the end seal member 60 may prevent the ingress of air, water, and / or other contaminants into the interior of the adapter 30 through the distal open end 36 of the body portion 32 of the adapter 30.

[0037] In some embodiments, the end seal member 60 may be made entirely or partially of a pierceable septum. As an example, the end seal member 60 may be configured to be pierced by a needle of a syringe. As a further example, the end seal member 60 may be a standard 20 mm stopper for vials.

[0038] In some embodiments, a fastener 62 may be used to secure the end seal member 60 to the cylindrical wall 38. The fastener 62 may be configured to hold or clamp the proximal end surface 60a of the end seal member 60 against the distal end surface 42 of the cylindrical wall 38. A clamping force provided by the fastener 62 may help ensure an air-tight or substantially air-tight and / or fluid-tight seal or substantially fluid-tight seal between the proximal end surface 60 of the end seal member 60 and the distal end surface 42 of the cylindrical wall 38. In some embodiments, including the embodiment illustrated in Figs. 4 and 5, the fastener 62 may take the form of a crimp ring, including, for example, a standard 20 mm aluminum crimp ring for vials. The crimp ring may be applied to the flange 40 of the cylindrical wall 38 using a crimping tool in some embodiments. As seen in Fig.5, the crimp ring may include radially inwardly extending flanges that abut against, respectively, a proximal end surface 40a of the flange 40 and a distal end surface 60b of the end seal member 60.

[0039] In addition to or as an alternative to the fastener 62, an adhesive and / or a threaded engagement, snap-like engagement, and / or other direct mechanical engagement may be used to secure the end seal member 60 to the cylindrical wall 38.

[0040] In some embodiments, the fastener 62 may removably couple the end seal member 60 to the body portion 32, such that, for example, the used end seal member 60 can be decoupled from the body portion 32 and replaced with a new end seal member. In other embodiments, the fastener 62 may permanently couple the end seal member 60 to the body portion 32.

[0041] Referring to Fig. 5, when the ampoule 10, after having been opened, is arranged in the body portion 32 with the first and second inner sealing members 52 and 54 sealingly engaging the outer surface of the opened ampoule 10, a sealed interior space 64 within the adapter 30 may be formed. This sealed interior space 64 may be defined, partially or entirely, by the first sealing member 52 and / or the second sealing member 54, the cylindrical wall 38, and the end seal member 60. Furthermore, the sealed interior space 64 may be free of or substantially free of contaminants. Since the opening 20 caused by breaking open the ampoule 10 may be disposed within the sealed interior space 64, contaminants and / or other elements from the external environment may be prevented or inhibited from entering the ampoule 10 through the opening 20 and potentially degrading and / or contaminating the contents of the ampoule 10.

[0042] Accordingly, the adapter 30 in its assembled or functional state may reseal the ampoule 10 after it has been broken open. Any unused contents of the ampoule 10 therefore may be preserved for use at a later time. Furthermore, as the exterior dimensions of the adapter 30 may emulate those of a standard vial as discussed above, the combined adapter 30 and opened ampoule 10 may be compatible for processing and / or handling by equipment, tools, automated systems, etc. designed for processing and / or handling standard vials.

[0043] An embodiment of a method of using the adapter 30 in conjunction with the ampoule 10 will now be described. Any one or combination of the the following steps may be performed manually by a person and / or automatically by a machine.

[0044] Initially, with the adapter 30 in the initial or pre-assembled state, a user or manufacturer may insert the (unopened) ampoule 10 through the proximal open end 34 of the body portion 32 and move the ampoule 10 in the distal direction along the longitudinal axis A until it reaches the position shown in Fig. 2, where the distal end 16 of ampoule 10 protrudes out through the distal open end 36 of the body portion 32. When moving the ampoule 10 distally through the body portion 32, the outer surface of the proximal end 14 of the ampoule 10 may slidably and sealingly engage the first and second inner sealing members 52 and 54. The ampoule 10 may be stored in this position within the adapter 30 until there is a need to access the contents of the ampoule 10. At that point, the ampoule 10 may be pulled out of the body portion 32 by moving the ampoule 10 in a proximaldirection along the longitudinal axis A. When moving the ampoule 10 proximally through the body portion 32, the outer surface of the proximal end 14 of the ampoule 10 may slidably engage the first and second inner sealing members 52 and 54 of the adapter 30. In alternative embodiments, the unopened ampoule 10 may not be stored within the adapter 30 in the initial or preassembled state.

[0045] Next, the distal end 16 of the ampoule 10 may be broken or snapped off of, or otherwise permanently or semipermanently detached from, the proximal end 14 of the ampoule 10. In some embodiments, this may involve a user grasping the distal end 16 of the ampoule 10 in one hand, grasping the proximal end 14 of the ampoule 10 in the other hand, and then breaking or snapping off the distal end 16 from the proximal end 14. By detaching the distal end 16, the opening 20 may be formed in the proximal end 14. The user may then withdraw the contents of the ampoule 10. An example, the user may cause a needle of a syringe to penetrate through the end seal member 60 into the ampoule 10 and then suction the contents of the ampoule 10 through the needle into a barrel of the syringe.

[0046] Shortly prior to or shortly after breaking open the ampoule 10, the user may convert the adapter 30 from its initial or pre-assembled state into the functional or assembled state. This may involve the user covering the distal 36 of the body portion 32 with the end seal member 60 and securing the end seal member 60 to the body portion 32 via, for example, the fastener 62. In securing the end seal member 60, the user may seal the interface between the distal end surface 42 of the body portion 32 and the proximal end surface 60a of the end seal member 60. In embodiments where the fastener 62 is a crimp ring, securing the end seal member 60 to the body portion 32 may involve use of a crimping tool for folding the axial ends of the crimp ring at least partially over, respectively, the distal end surface 60b of the end seal member 60 and the proximal end surface 40a of the flange 40.

[0047] Subsequently, the user may insert the opened ampoule 10 through the proximal open end 34 of the body portion 32 and move the ampoule 10 in the distal direction along the longitudinal axis A until it reaches the position shown in Fig. 5, where the opening 20 of the ampoule 10 is disposed within the distal portion 38b of the body portion 32. When moving the ampoule 10 distally through the body portion 32, the outer surface of the proximal end 14 of the ampoule 10 may slidably and sealingly engage the first and second inner sealing members 52 and 54. Once the ampoule 10 is positioned as shown in Fig. 5, the opening 20 of the ampoule 10 may be shielded from external elements in the surrounding environment as a result of being positioned within the sealed interior space 64, which is defined partially or entirely, by the first sealing member 52 and / or the second sealing member 54, the cylindrical wall 38, and the end seal member 60. Accordingly, the ampoule 10 may be effectively resealed. In alternative embodiments, the end seal member 60 may be secured to the body portion 32 after the opened ampoule 10 has been inserted into the body portion.

[0048] When there is a need or desire to once again access the contents of the ampoule 10, the ampoule 10 may be pulled out of the body portion 32 by moving the ampoule 10 in a proximal direction along the longitudinal axis A. When moving the ampoule 10 proximally through the body portion 32, the outer surface of the proximal end 14 of the ampoule 10 may slidably engage the first and second inner sealing members 52 and 54 of the adapter 30. Subsequently, if desired, the ampoule 10 can be inserted into the adapter 30 to reseal the ampoule 10 again.

[0049] In some embodiments, the adapter 30 may be reused for resealing multiple different ampoules. For example, after the adapter 30 has been used to reseal an ampoule and this ampoule has been emptied or discarded, the end seal member 60 may be removed from the adapter 30 and replaced with a new end seal member. Thereafter, another ampoule may be inserted into the adapter 30 for resealing and this process can be repeated as needed.

[0050] All features described herein, including in the specification, claims, abstract, and drawings, and all the steps in any method or process described herein, may be combined in any combination, except combinations where one or more of the features and / or steps are mutually exclusive.

[0051] As will be recognized, the systems and methods according to the present disclosure may have one or more advantages relative to conventional technology, any one or more of which may be present in a particular embodiment in accordance with the features of the present disclosure included in that embodiment. Other advantages not specifically listed herein may also be recognized as well.

[0052] The above description describes various devices, assemblies, components, subsystems and methods for use related to a drug delivery device. The devices, assemblies, components, subsystems, methods or drug delivery devices can further comprise or be used with a drug including but not limited to those drugs identified below as well as their generic and biosimilar counterparts. The term drug, as used herein, can be used interchangeably with other similar terms and can be used to refer to any type of medicament or therapeutic material including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biologies, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics. Non-therapeutic injectable materials are also encompassed. The drug may be in liquid form, a lyophilized form, or in a reconstituted from lyophilized form. The following example list of drugs should not be considered as all-inclusive or limiting.

[0053] The drug will be contained in a reservoir. In some instances, the reservoir is a primary container that is either filled or pre-filled for treatment with the drug. The primary container can be a vial, a cartridge or a pre-filled syringe.

[0054] In some embodiments, the reservoir of the drug delivery device may be filled with or the device can be used with colony stimulating factors, such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include but are not limited to Neulasta® (pegfilgrastim, pegylated filgastrim , pegylated G-CSF, pegylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim- bmez).

[0055] In other embodiments, the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, an ESA is an erythropoiesis stimulating protein. As used herein, “erythropoiesis stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor. Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK- 2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, as well as the molecules or variants or analogs thereof.

[0056] Among particular illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL specific antibodies, peptibodies, related proteins, and the like (also referred to as RANKL specific antibodies, peptibodies and the like), including fully humanized and human OPGL specific antibodies, particularly fully humanized monoclonal antibodies; Myostatin binding proteins, peptibodies, related proteins, and the like, including myostatin specific peptibodies; IL-4 receptor specific antibodies, peptibodies, related proteins, and the like, particularly those that inhibit activities mediated by binding of IL-4 and / or IL-13 to the receptor; Interleukin 1-receptor 1 (“IL1-R1”) specific antibodies, peptibodies, related proteins, and the like; Ang2 specific antibodies, peptibodies, related proteins, and the like; NGF specific antibodies, peptibodies, related proteins, and the like; CD22 specific antibodies, peptibodies, related proteins, and the like, particularly human CD22 specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgGantibodies, such as, a dimer of a human-mouse monoclonal h LL2 gamma-chain disulfide linked to a human-mouse monoclonal h LL2 kappa-chain, for example, the human CD22 specific fully humanized antibody in Epratuzumab, CAS registry number 501423-23-0; IGF-1 receptor specific antibodies, peptibodies, and related proteins, and the like including but not limited to anti- IGF-1 R antibodies; B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (“B7RP-1” and also referring to B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human monoclonal lgG2 antibodies, including but not limited to fully human lgG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells; IL-15 specific antibodies, peptibodies, related proteins, and the like, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, such as, for instance, 145c7; IFN gamma specific antibodies, peptibodies, related proteins and the like, including but not limited to human IFN gamma specific antibodies, and including but not limited to fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, and the like, and other TALL specific binding proteins; Parathyroid hormone (“PTH”) specific antibodies, peptibodies, related proteins, and the like; Thrombopoietin receptor (“TPO-R”) specific antibodies, peptibodies, related proteins, and the like;Hepatocyte growth factor (“HGF”) specific antibodies, peptibodies, related proteins, and the like, including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter (HGF / SF); TRAIL-R2 specific antibodies, peptibodies, related proteins and the like; Activin A specific antibodies, peptibodies, proteins, and the like; TGF-beta specific antibodies, peptibodies, related proteins, and the like; Amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like; c-Kit specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind OX40L and / or other ligands of the 0X40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa) Erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], Darbepoetin alfa, novel erythropoiesis stimulating protein (NESP); Epogen® (epoetin alfa, or erythropoietin); GLP- 1, Avonex® (interferon beta-1 a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti- a4B7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TN F-receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, Human Growth Hormone); Herceptin® (trastuzumab, anti-HER2 / neu (erbB2) receptor mAb); Kanjinti ™ (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar to Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancers; Humatrope® (somatropin, Human Growth Hormone); Humira® (adalimumab); Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand, Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxy polyethylene glycol- epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1 A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1);OvaRex® (B43.13); Nuvion® (visilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFa monoclonal antibody); Reopro® (abciximab, anti-GP llb / llia receptor monoclonal antibody); Actemra® (anti-l L6 Receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); MvasiTM (bevacizumab- awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A®-(interferon alfa-2a); Simulect® (basiliximab);Prexige® (lumiracoxib); Synagis® (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri® (natalizumab, anti-a4integrin mAb); Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the Fc portion of human IgG 1 and the extracellular domains of both IL-1 receptor components (the Type I receptor and receptor accessory protein)); VEGF trap (Ig domains of VEGFR1 fused to IgG 1 Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-l L-2Ra mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-lg); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); ONTO 148 (golimumab, anti-TNFa mAb); HGS-ETR1 (mapatumumab; human anti- TRAIL Receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-a5 1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti- C. difficile Toxin A and Toxin B C mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF Idiopathic Pulmonary Fibrosis Phase I Fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; antiganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF Receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-IFNa mAb (MEDI-545, MDX-198); anti-IGF1 R mAb; anti-IGF-1 R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-l L12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-l L2Ra mAb (HuMax-TAC); anti-l L5 Receptor mAb; anti-integrin receptors mAb (MDX-018, CNTO 95); anti-IP10 Ulcerative Colitis mAb (MDX-1100); BMS-66513; anti-Mannose Receptor / hCGp mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1mAb (MDX-1106 (ONO-4538)); anti-PDGFRa antibody (IMC-3G3); anti-TGFB mAb (GC-1008); anti-TRAIL Receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti- VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0057] In some embodiments, the drug delivery device may contain or be used with a sclerostin antibody, such as but not limited to romosozumab, blosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for treatment of postmenopausal osteoporosis and / or fracture healing and in other embodiments, a monoclonal antibody (IgG) that binds human Proprotein Convertase Subtilisin / Kexin Type 9 (PCSK9). Such PCSK9 specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with or the device can be used with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers including but are not limited to OncoVEXGALV / CD; OrienXOW; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors of metalloproteinases (TIMPs) such as but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor) or another product containing erenumab for the treatment of migraine headaches. Antagonistic antibodies for human calcitonin gene-related peptide (CGRP) receptor such as but not limited to erenumab and bispecific antibody molecules that target the CGRP receptor and other headache targets may also be delivered with a drug delivery device of the present disclosure. Additionally, bispecific T cell engager (BITE®) molecules such as but not limited to BLINCYTO® (blinatumomab) can be used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used with an APJ large molecule agonist such as but not limited to apelin or analogues thereof. In some embodiments, a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used with AvsolaTM (infliximab-axxq), anti- TNF a monoclonal antibody, biosimilar to Remicade® (infliximab) (Janssen Biotech, Inc.) or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used withKyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2- ((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used with Otezla® (apremilast), N-[2-[(1 S)-1 -(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1 ,3-dioxo- 1 H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases. In some embodiments, the drug delivery device may contain or be used with ParsabivTM (etelcalcetide HCI, KAI-4169) or another product containing etelcalcetide HCI for the treatment of secondary hyperparathyroidism (sHPT) such as in patients with chronic kidney disease (KD) on hemodialysis. In some embodiments, the drug delivery device may contain or be used with ABP 798 (rituximab), a biosimilar candidate to Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF antagonist such as a non-antibody VEGF antagonist and / or a VEGF-Trap such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2, fused to Fc domain of IgG 1 ). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate to Soliris®, or another product containing a monoclonal antibody that specifically binds to the complement protein C5. In some embodiments, the drug delivery device may contain or be used with Rozibafusp alfa (formerly AMG 570) is a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with Omecamtiv mecarbil, a small molecule selective cardiac myosin activator, or myotrope, which directly targets the contractile mechanisms of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with Sotorasib (formerly known as AMG 510), a KRASG12C small molecule inhibitor, or another product containing a KRASG12C small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with Tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to Interleukin-15 (IL-15) or another product containing a human monoclonal antibody that binds to Interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein(a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that lowers lipoprotein(a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human I gG 1 kappa antibody), a biosimilar candidate to Stelara®, or another product that contains human I gG 1 kappa antibody and / or binds to the p40 subunit of human cytokines interleukin (I L)- 12 and IL-23. In some embodiments, the drug delivery device may contain or be used with AmjevitaTM or AmgevitaTM (formerly ABP 501) (mab anti-TNF human IgG 1 ), a biosimilar candidate to Humira®, or another product that contains human mab anti-TNF human lgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160, or another product that contains a half-life extended (HLE) anti- prostate-specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cellular therapy. In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cellular therapy. In some embodiments, the drug delivery device may contain or be used with AMG 133, or another product containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and GLP-1 R agonist. In some embodiments, the drug delivery device may contain or be used with AMG 171 or another product containing a Growth Differential Factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with AMG 176 or another product containing a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199 or another product containing a half-life extended (HLE) bispecific T cell engager construct (BITE®). In some embodiments, the drug delivery device may contain or be used with AMG 256 or another product containing an anti-PD- 1 x IL21 mutein and / oran IL-21 receptor agonist designed to selectively turn on the Interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330 or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404 or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 427 or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 430 or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506 or another product containing a multi-specific FAP x 4-1 BB-targeting DARPin® biologic under investigation as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 509 or another product containing a bivalent T-cell engager and is designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG 562 or another product containing a half-life extended (HLE) CD19 x CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with Efavaleukin alfa (formerly AMG 592) or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with AMG 596 or another product containing a CD3 x epidermal growth factor receptor vl 11 (EGFRvlll) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with AMG 673 or another product containing a half-life extended (HLE) anti-CD33 x anti- CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 701 or another product containing a half-life extended (HLE) anti-B-cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 757 or another product containing a half-life extended (HLE) anti- delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0058] Although the drug delivery devices, assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the present disclosure. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent that would still fall within the scope of the claims defining the invention(s) disclosed herein.

[0059] Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the above described embodiments without departing from the spirit and scope of the invention(s) disclosed herein, and that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept(s).

Claims

What is claimed is:

1. An adapter for an ampoule, the adapter comprising: a body portion configured to receive at least a portion of the ampoule; and a first inner seal member disposed at least partially within the body portion and configured to sealingly engage the ampoule.

2. The adapter of claim 1, wherein the body portion comprises a proximal open end and a distal open end.

3. The adapter of claim 2, comprising an end seal member covering the distal open end of the body portion.

4. The adapter of claim 3, wherein the first inner seal member and the end seal member are configured to at least partially define a sealed interior space in which an open end of the ampoule can be disposed.

5. The adapter of any one of claims 2 to 4, wherein the end seal member comprises a pierceable septum.

6. The adapter of any one of claims 2 to 5, wherein the end seal member is removably coupled with the body portion.

7. The adapter of any one of claims 2 to 6, comprising an opening allowing a user to view a lateral side of the ampoule when the ampoule is received in the adapter.

8. The adapter of claim 7, wherein the opening is positioned in an axial direction between the first inner seal member and the proximal open end of the body portion.

9. The adapter of any one of claims 1 to 8, wherein the first inner seal member is coupled with or formed by an inner surface of the body portion.

10. The adapter of any one of claims 1 to 9, wherein at least a portion of the first inner seal member is ring-shaped and made of an elastomeric material.

11. The adapter of any one of claims 1 to 10, wherein the first inner seal member comprises an O-ring.

12. The adapter of any one of claims 1 to 11, comprising a second inner seal member disposed at least partially within the body portion and configured to sealingly engage the ampoule.

13. The adapter of claim 12, wherein the first inner seal member and the end seal member are disposed at respective axial positions along a longitudinal axis of the body portion.

14. The adapter of any one of claims 1 to 13, wherein the body portion comprises a cylindrical wall.

15. The adapter of claim 14, wherein a proximal portion of the cylindrical wall has a first inner diameter and a distal portion of the cylindrical wall has a second inner diameter, wherein the second inner diameter is less than the first inner diameter.

16. The adapter of claim 15, wherein the first inner seal member is coupled with or formed by an inner surface of the proximal portion of the cylindrical wall.

17. A method of resealing an ampoule after the ampoule has been opened, the method comprising: inserting an open end of the ampoule into a body portion of an adapter; and sealingly engaging the ampoule with a first inner seal member disposed at least partially within the body portion of the adapter.

18. The method of claim 17, wherein the body portion of the adapter comprises a proximal open end and a distal open end.

19. The method of claim 18, comprising, prior to inserting the open end of the ampoule into the body portion of the adapter, covering the distal open end of the body portion of the adapter with an end seal member.

20. The method of claim 19, comprising coupling the end seal member to the body portion with a fastener.

21. The method of claim 20, wherein the fastener comprises a crimp ring.

22. The method of any one of claims 19 to 21, comprising positioning the open end of the ampoule in an axial direction between the first inner seal member and the end seal member.

23. The method of any one of claims 19 to 22, wherein the end seal member comprises a pierceable septum.

24. The method of any one of claims 19 to 23, comprising inserting a needle through the end seal member and the open end of the ampoule into an interior of the ampoule.

25. The method of claim 24, comprising withdrawing a liquid from the ampoule via the needle.

26. The method of any one of claims 17 to 25, wherein the adapter comprises the adapter of any one of claims 1 to 16.

27. An ampoule assembly comprising: an adapter comprising a body portion and a first inner seal member, wherein at least a portion of the first inner seal member is disposed at least partially within the body portion; and an ampoule comprising an outer surface, wherein the first inner seal member of the adapter sealingly engages the outer surface of the ampoule.

28. The ampoule assembly of claim 27, wherein the body portion of the adapter comprises a proximal open end and a distal open end.

29. The ampoule assembly of claim 28, wherein the ampoule has a proximal end disposed within the body portion of the adapter and a distal end extending out through the distal open end of the body portion of the adapter.

30. The ampoule assembly of claim 28, wherein the adapter comprises an end seal member covering the distal open end of the body portion.

31. The ampoule assembly of claim 30, wherein the ampoule comprises an open end positioned in an axial direction between the first inner seal member and the end seal member.

32. The ampoule assembly of any one of claims 27 to 31, wherein the ampoule is made partially or entirely of glass.

33. The ampoule assembly of any one of claims 27 to 32, wherein the ampoule, prior to being opened, comprises a sealed interior space filled at least partially with a liquid.

34. The ampoule assembly of claim 33, wherein the liquid comprises a drug.

35. The ampoule assembly of any one of claims 27 to 34, wherein the adapter comprises the adapter of any one of claims 1 to 16.

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