CN106880494B

CN106880494B - Packaging assembly for preventing premature activation

Info

Publication number: CN106880494B
Application number: CN201710063621.8A
Authority: CN
Inventors: 斯科特·R·阿里亚格诺; 马克·D·席林; 托马斯·V·普拉
Original assignee: Hundred Deep Co; Hundred Deep LLC
Current assignee: Takeda Pharmaceutical Co Ltd
Priority date: 2012-02-22
Filing date: 2012-02-22
Publication date: 2019-12-31
Anticipated expiration: 2032-02-22
Also published as: PL2817240T3; SG11201405126XA; HUE029693T2; CN106880494A; CN104136344A; EP2817240A1; CA2865002A1; JP2015509401A; KR20140125875A; EP2817240B1; KR101763459B1; CN104136344B; AU2012370463B2; AU2012370463A1; BR112014020595A8; CA2865002C; JP6014868B2; BR112014020595B1; WO2013126055A1; ES2576294T3

Abstract

The present invention relates to a packaging assembly (10) for a pharmaceutical reconstitution assembly (100) that prevents premature activation comprising a body (14), a pharmaceutical reconstitution assembly (100) and a removable lid (12). The body includes a plurality of protrusions (16, 18) configured to mate with a plurality of corresponding components of the drug reconstitution assembly to inhibit axial and rotational translation of the drug reconstitution assembly and its components during shipping and handling. By preventing axial and rotational movement during transport, premature and accidental puncturing or contamination of the medication or puncture within the medication reconstitution assembly is minimized.

Description

Packaging assembly for preventing premature activation

The present application is a divisional application of the chinese application having application number 201280070539.3, application date 2012-2-22 entitled "packaging assembly for preventing premature activation".

Technical Field

The present disclosure relates generally to medical package device assemblies, and more particularly to combinations of packages and medical devices.

Background

The specific drug is supplied in lyophilized form. The lyophilized drug must be mixed with water to reconstitute the drug into a form suitable for injection into a patient. In particular, the components forming the injectable solution must be sterile in order to avoid infection. The reconstitution process presents difficulties to patients or caregivers who need to inject themselves or by others (e.g., in a residential setting). The patient or caregiver must follow the sequential operation of the medication container, the dilution container, and the transfer syringe, and use the needle to pierce the stopper associated with the respective container. The patient or caregiver needs to follow established aseptic procedures to avoid contamination.

As described in U.S. patent application No.13/217,967 ("the' 967 application"), the disclosure of which is incorporated herein by reference in its entirety, the drug container, the dilution container, and the transfer syringe of the device are mounted within the same housing when shipped from the manufacturer, distributor, or assembler to the end user. Due to the particular arrangement of the transfer syringe with respect to each of the drug containers, special care is taken to prevent accidental premature puncturing or activation of the container stopper by the transfer syringe during shipping and handling. Thus, shipping of reconstitution devices presents challenges in preventing premature activation of the product, thereby ensuring sterility and enabling easy use of the product by the end user. Lyophilized drugs are often very expensive, making it even more important to minimize accidental activation or contamination during transport.

Disclosure of Invention

The present disclosure provides a packaging assembly including a package and a reconstitution assembly and related medical products that prevents premature activation of the reconstitution assembly. The package is shaped like placing the reconstituted assembly in a bassinet. The package integrates the associated components of the reconstitution assembly and maintains the various portions of the reconstitution assembly isolated from each other in the package during shipping and handling.

In one embodiment, the reconstitution assembly includes a housing having an upper cannula and a lower cannula. The housing defines a generally tubular passage and includes a plurality of radially spaced apertures in the upper sleeve and a plurality of radially spaced windows in the lower sleeve. A transfer set assembly is disposed within the housing between the upper and lower casings. The transfer set assembly includes a pair of opposing punctures including a lower puncture and an upper puncture. The upper and lower punctures form a portion of the flow path.

The first container is disposed at least partially within the upper sleeve of the housing, in the passageway and proximate the upper spike. The first container includes a first vial and a first stopper that provides a sterile barrier to medical contents held within the first vial. In one embodiment, the first container is arranged such that the first stopper faces downward or towards the centre of the housing. A second container is disposed within the lower cannula in the passageway and proximate the lower spike. The second container includes a second vial and a second stopper that provides a sterile barrier to the contents of the second vial. In one embodiment, the second container is arranged such that the second stopper faces upwardly towards the first stopper. The flow path formed by the piercing allows the containers to be in fluid communication with each other when pierced.

In an embodiment, upon application of a first force to the first container, the upper spike of the transfer set assembly pierces the first stopper. The force can come from the patient or caregiver pressing down on the first container, pushing the first container into the housing and onto the upper spike. After the upper spike pierces the first stopper of the first container, the second container is allowed to move axially relative to the transfer set assembly. Then, upon application of the second force and engagement of the trigger mechanism by the first container, and in particular by the first vial of the first container, the lower spike of the transfer set assembly pierces the second stopper. When the second stopper is pierced, the vacuum of the second container is entered. The first and second forces may be predetermined forces or may be at desired levels.

In an embodiment, the first container encloses a liquid and the second container encloses a lyophilized product. The first stopper of the first container is pierced with an upper puncture and the second stopper of the second container is pierced with a lower puncture placing the first and second containers in fluid communication with each other through the flow path of the transfer set assembly. The vacuum of the second container then causes the liquid of the first container to be drawn into the second container through the fluid pathway. The liquid is mixed with the lyophilized drug to formulate the drug for patient use.

The packaging assembly is configured such that the reconstitution assembly fits within the packaging and the packaging physically inhibits axial translation of the first or second container within the housing. By inhibiting any significant axial translation of the first or second container within the housing, accidental or premature puncturing of the first stopper of the first container by an upper puncture or the second stopper of the second container by a lower puncture is prevented.

In an embodiment, the package includes an interior chamber formed with a plurality of recesses and protrusions shaped to complement mating features of the reconstitution assembly. The interior chamber of the package is formed such that the reconstitution assembly properly engages the complementary recesses and protrusions of the package in a predetermined configuration. For example, there are first and second recesses at the ends of the package that hug (crade) first and second vials of first and second containers extending from the housing of the reconstitution assembly. A plurality of protrusions extending into the interior chamber of the package mate with and extend through a plurality of apertures in the upper sleeve and a plurality of apertures in the lower sleeve of the housing of the reconstitution assembly.

An aperture in the housing allows the protrusion of the packaging body to extend into the channel formed by the housing and engages the vial, which can be a glass vial with a neck opening, around a portion of the neck of the vial. The protrusion engages the aperture of the housing to prevent the first and second respective containers from rotating within the package. The engagement of the protrusions with the vial neck also prevents inadvertent axial translation of the containers relative to each other, relative to the transfer set assembly, or relative to the housing. By keeping the first and second containers substantially axially stationary with respect to each other and with respect to the transfer set assembly, the protrusion of the interior chamber of the package body maintains the upper and lower punctures at a separation distance from each of the first and second containers, respectively. Because axial translation of the components of the reconstitution assembly during shipping and handling is minimized or prevented, premature puncturing of the first and second containers by the respective punctures of the transfer set assembly is also minimized.

Additional features and advantages are described herein, and will be apparent from, the following detailed description and the figures.

Drawings

Fig. 1 is a perspective view of one embodiment of an assembled package of the present disclosure.

FIG. 2 is an exploded view of one embodiment of the package, reconstitution assemblies contained within the package, and a lid for the package of the present disclosure.

Fig. 3 is a body side view of one embodiment of an assembled package and pharmaceutical reconstitution assembly of the present disclosure.

Fig. 4 is a cross-sectional view of the assembled package of fig. 3 taken along line IV-IV of fig. 3.

FIG. 5 is a bottom view of one embodiment of the package of the present disclosure.

Fig. 6 is a cross-sectional view of the package of fig. 5 taken along line VI-VI of fig. 5.

Fig. 7 is a side view of one embodiment of an assembled package of the present disclosure.

Fig. 8 is an end view of one embodiment of an assembled package of the present disclosure.

Detailed Description

The present disclosure provides a packaging assembly comprising an assembled package and a reconstituted assembly. The packaging assembly is particularly useful for preventing premature activation of the reconstitution assembly during shipping and handling. While the packaging assembly is primarily described herein as including a reconstituted assembly, it should be understood that a suitably configured package may be used during shipping of other pharmaceutical assemblies or other products having components that are separated prior to use.

Referring now to the drawings and in particular to fig. 1 and 2, an assembled package 10 is generally indicated. The assembled package 10 generally includes a removable lid 12, a body 14, and a pharmaceutical reconstitution assembly 100 (fig. 2).

The removable cover 12 can be made of any one or more high density polyethylene fibers such asA foil material or paper material, and in one embodiment, the removable cover 12 is adhered to the body 14 by a heat activated adhesive. The adhesive and application process is such that the removable cover 12 remains firmly adhered to the body 14, but may also be more easily removed by the patient.

The body 14 can be constructed of a heat-deformable polyethylene terephthalate ("PET") material. The body 14 can be formed into a desired shape of the body 14 by the protrusions 16 and 18, wells (wells) 20a to 20c, and the like formed by a thermoforming process. In an alternative embodiment, the body 14 is made of a polymeric material and is formed by an injection molding process.

As shown in fig. 1 and 2, the lid 12 is sealingly and removably attached to the body 14, thereby enclosing the pharmaceutical reconstitution assembly 100 within the package 10. The removable cover 12 can provide a flat surface on which manufacturer instructions and identifying information can be displayed. The information identifier may include a bar code, a graphic code, company information, and an internet address to guide the user to more detailed information. This information may include medical information, patient identification and prescription information, manufacturer information, licensing and government agency information, production and expiration date information, and instructions for use.

As shown in fig. 1 and 2, the body 14 is formed to define an interior chamber including a plurality of projections 16 and 18 projecting into the chamber, and wells 20 a-20 c extending out from the interior of the chamber. These features are described in more detail below. As used herein, a protrusion extends generally toward the center of the interior chamber of the body 14, while a well extends generally away from the center of the interior of the chamber.

The interior chamber receives the drug reconstitution assembly 100 illustrated in fig. 2. The drug reconstitution assembly 100 includes a housing 110, the housing 110 having an upper portion 112 (when held in use) and a lower portion 114 (when held in use). The upper portion 112 and the lower portion 114 form a generally cylindrical passage. The pharmaceutical reconstitution assembly 100 also includes: an upper receptacle 120 (when held in use), the upper receptacle 120 being at least partially received within the channel formed by the upper portion 112 of the housing; a lower receptacle 130 (when held in use), the lower receptacle 130 being at least partially received within the channel formed by the lower portion 114 of the housing; and a contact port plug 140, the contact port plug 140 being disposed on an exterior of the housing 110. The removable lid 12 of the package 10 is sealingly attached to the body 14, thereby enclosing the pharmaceutical reconstitution assembly 100 within the body 14.

Referring now to fig. 3, a body side view of the assembled package 10 from the outside is shown. The first and second pairs of projections 16, 18 extend from the surrounding surface of the body 14 into the interior chamber to contact mating components of the drug reconstitution assembly 100. Wells 20a, 20b, and 20c extend outwardly from the interior chamber relative to the surrounding surface of body 14. The wells 20a, 20b and 20c are at least substantially flat and coplanar with each other (see also fig. 1 and 2) so that the package 10 can be seated on the body side by placing the wells 20a, 20b and 20c on a stable surface. As shown in fig. 1-3, the body 14 also forms wells for end portions 22 and 24 at the upper and lower ends of the body 14.

Referring now to FIG. 4, a cross-sectional side view taken along line IV-IV of FIG. 3 is illustrated. Due to the radial spacing and geometry of the projections 16 as compared to the radial spacing and geometry of the projections 18, the line IV-IV has been exaggerated in FIG. 3 to better illustrate the cross-sections of both the projections 16 and the projections 18 in the single view of FIG. 4. The cross-sectional view of the reconstitution assembly 100 and its housing 110 illustrate the contents of the reconstitution assembly. Specifically, reconstitution assembly 100 includes a first or upper container 120, a second or lower container 130, and a transfer set assembly 200.

As discussed in detail in the' 967 application, which is incorporated herein by reference, the transfer set assembly 200 includes an upper puncture 202, a lower puncture 204, and a flow path that travels through the upper puncture 202 and the lower puncture 204. The upper spike 202 faces the first opening 128 of the upper container 120 and the lower spike 204 faces the second opening 138 of the lower container 130. In various embodiments, the plastic portion of transfer set assembly 200 is made of a suitable moldable and sterilizable plastic, such as acrylonitrile-butadiene-styrene ("ABS"), polycarbonate ("PC"), or acrylic.

The upper puncture 202 can include an upper boot 206, the upper boot 206 being configured to cover and maintain sterility of the lower portion of the upper puncture and the flow path portion of the upper puncture. Similarly, the lower puncture 204 includes a lower shield 208, the lower shield 208 configured to cover and maintain sterility of the upper portion and the flow path portion in the lower puncture. In one embodiment, the upper and lower shields 206, 208 are made of an elastomeric material, and the upper and lower shields 206, 208 are more easily pierced by the upper and lower punctures 202, 204, respectively, upon activation of the drug reconstitution assembly 100.

Transfer set assembly 200 can also include a syringe port passage (shown in fig. 2 below contact port plug 140) that is substantially perpendicular to the flow path traveled through upper and lower punctures 202 and 204 and maintains valved fluid communication with the flow path traveled through upper and lower punctures 202 and 204. The syringe port passage can alternatively not extend perpendicularly from the flow path of transfer set assembly 200. The syringe port passageway communicates with a syringe port extending through the housing 110 of the reconstitution assembly 100. In fig. 2, a contact port plug 140 engages the syringe port to maintain sterility of the port and the fluid path in the connection.

After the drug reconstitution assembly 100 is fully activated, the user removes the contact port plug 140 to expose the syringe port for access by the user through the separate syringe. The contact port plug 140 is made of an elastomeric material or a rubber material so that the contact port plug 140 can be bent for grasping and removal. The syringe port passageways and puncture flow paths allow fluid communication from the syringe ports to the upper and lower receptacles 120, 130.

The upper and lower containers 120, 130 comprise upper and lower vials 121, 131, for example, the upper and lower vials 121, 121 are made of a suitable medical grade sterilizable glass or plastic. The upper and lower vials 121, 131 are both generally cylindrical and have similar geometric profiles, including upper and lower neck portions 122a, 132a, base portion 122c, and base portion 132c and upper and lower edges 126, 136. The upper and lower neck portions 122a, 132a have a smaller diameter than the base portions 122c, 132c or the upper and lower edges 126, 136. The upper stopper 124 sealingly closes the first opening 128 of the upper vial 121, thereby preventing contamination or leakage of the contents of the upper container 120. Similarly, the lower stopper 134 sealingly closes the second opening 138 of the lower vial 131, thereby preventing contamination or leakage of the lower container 130. The upper 124 and lower stopper 134 can be made of rubber or an elastomeric material. It should be understood that the assembly of the upper vial 121 and the upper stopper 124 is defined herein as the upper container 120. Similarly, the assembly of the lower vial 131 and the lower stopper 134 is defined herein as the lower container 130.

Housing 110 of drug reconstitution assembly 100 includes an upper housing portion 112 and a lower housing portion 114, and upper housing portion 112 and lower housing portion 114 can also be made of acrylonitrile butadiene styrene ("ABS"), polycarbonate ("PC"), or acrylic. The upper housing portion 112 includes or defines a plurality of apertures 116, while the lower housing portion 114 includes or defines a plurality of apertures 118 (as best shown in FIG. 2). The apertures or windows 116 and 118 are both radially spaced about the respective housing. The apertures 116 and 118 allow the flow of sterilizing gas to the interior portion and components of the pharmaceutical reconstitution assembly 100. In addition to facilitating the sterilization process, apertures 116 and 118 provide at least partial contact to upper receptacle 120 and lower receptacle 130 when housed in reconstitution enclosure 110.

As discussed in more detail in the' 967 application, upon activation of the drug reconstitution assembly 100, the upper spike 202 pierces the upper shield 206 and the upper stopper 124 to contact the contents of the upper container 120, and thereafter, the lower spike 204 pierces the lower shield 208 and the lower stopper 134 to contact the contents of the lower container 130. When the upper and lower punctures 202 and 204 have contacted the contents of the upper and lower containers 120 and 130, respectively, a flow path is created between the upper and lower containers 120 and 130. The' 967 application discusses other internal mechanisms of the drug reconstitution assembly 100 that ensure that the upper container 120 travels toward the upper spike 202 and the upper stopper 124 is fully pierced by the upper spike 202 before the lower spike 204 can contact the lower stopper 134 of the lower container 130.

Fig. 4 illustrates how the upper and lower containers 120, 130 fit within the housing 110 of the drug reconstitution assembly 100 and how the drug reconstitution assembly 100 fits within the interior chamber of the package body 14 during shipping (inactivated state). As shown, the upper receptacle 120 fits at least partially within the upper housing portion 112. The upper rim 126 and the upper stopper 124 of the upper vial 121 are both oriented toward the transfer set assembly 200 and the upper spike 202. In the inactive state shown, the upper stopper 124 of the upper container 120 is disposed proximate to the upper spike 202, but does not contact the upper spike 202.

The upper housing portion 112 in one embodiment includes three apertures 116 arranged substantially uniformly radially about the upper housing portion 112, as partially shown in FIG. 2. It should be appreciated that any number of apertures may be included in the upper housing portion 112 and the spacing need not be equal or radial. The upper housing portion 112 is formed such that when the upper container 120 is secured in its shipping configuration, various components of the upper vial 121, such as the upper shoulder 122b, the upper neck 122a and the upper rim 126, are longitudinally aligned with the aperture 116.

Similar to the upper receptacle 120, the lower receptacle 130 fits at least partially within the lower housing portion 114. The lower rim 136 of the lower vial 131 and the lower stopper 134 are both oriented toward the lower puncture 204 of the transfer set assembly 200. In the inactivated state (as shown), the lower stopper 134 of the lower container 130 is disposed proximate to the lower puncture 204, but does not contact the lower puncture 204 of the shifter assembly 200.

The lower housing portion 114 in one embodiment includes six apertures 118 evenly radially disposed about the lower housing portion 114, as partially shown in FIG. 2. Any number of apertures may be included in the lower housing portion 114 and need not be equally or radially spaced. In fig. 4, two of the holes 118 of the lower housing portion 114 are visible. The lower housing portion 114 is formed such that when the lower container 130 is secured in its shipping configuration, various components of the lower vial 131, such as the lower shoulder 132b, lower neck 132a and lower rim 136, are longitudinally aligned with the aperture 118.

Importantly, the upper and lower containers 120, 130 do not move out of their shipping configuration until the user intentionally activates the drug reconstitution assembly 100. Such undesired displacement of the upper or lower containers 120, 130 due to shipping, handling or mishandling can result in premature contact between the upper or lower punctures 202, 204 and the corresponding upper or lower stoppers 124, 134. Even, the rupture or interference of the upper and lower shields 206, 208 by the respective upper and lower punctures 202, 204 can disrupt the sterile environment of the flow path traveled by the upper and lower punctures 202, 204 of the transfer set assembly 200. As discussed in more detail below, the package 10 prevents these undesirable displacements.

It should be understood that for purposes of this disclosure, an undesirable displacement is defined as any one of a number of different resulting positions of the following components, namely: upper and lower containers 120, 130, upper and lower punctures 202, 204, upper and lower stoppers 124, 134, upper and lower guards 206, 208, transfer set assembly 200, and housing 110. Each of the undesirable displacement positions that can occur accidentally during transport is prevented by the interaction of the body 14 with the pharmaceutical reconstitution assembly 100. Described below are several undesirable displacement positions. It should be appreciated that while discussed with respect to both the upper and lower receptacles, it is contemplated that each of the undesirable displacement positions apply individually or collectively to the upper receptacle 120 and the lower receptacle 130.

In the first undesirable displacement position, the upper container 120 or the lower container 130 is axially offset relative to the transfer set assembly 200 such that the upper stopper 124 or the lower stopper 134 contacts the upper shield 206 or the lower shield 208, which in turn contacts and is at least partially pierced by the upper puncture 202 or the lower puncture 204, respectively. It will be appreciated that in the first undesirable displacement position, the respective upper and lower punctures 202 and 204 do not fully penetrate the upper stopper 124 or the lower stopper 134. In the first undesirable displacement position, the upper and lower shields 206, 208 are pierced by the respective upper and lower punctures 202, 204, rendering the transfer set assembly 200 and its flow path susceptible to contamination.

In the second undesirable displacement position, the upper container 120 or the lower container 130 is axially displaced relative to the transfer set assembly 200 such that the upper stopper 124 or the lower stopper 134 contacts the upper shield 206 or the lower shield 208, respectively. The upper shield 206 or the lower shield 208 is then pressed against the upper spike 202 or the lower spike 204 by axial translation of the respective container. In the second undesired displacement position, either the upper spike 202 or the lower spike 204 fully pierces the respective upper and lower shields 206, 208 and at least partially pierces the upper and lower stoppers 124, 134 of the respective upper and lower containers 120, 130. In the second undesirable displacement position of the various embodiments, the upper and lower punctures 202 and 204 fully pierce the respective upper and lower stoppers 124 and 134. In the second undesired displacement position, the upper stopper 124 or the lower stopper 134 is partially or fully pierced by the upper puncture 202 or the lower puncture 204, resulting in an increased chance of contamination of the transfer set assembly 200 and of the contents of the upper container 120 or the lower container 130.

In the third undesired displacement position, the upper container 120 or the lower container 130 is radially or axially offset with respect to the outer housing 110, resulting in a failure of the seal between the upper vial 121, the lower vial 131 and the interior of the outer housing 110. In the third undesirable displacement position, the failed seal can reduce the secure positioning of the upper and lower vessels 120, 130 in the housing 110, thereby increasing the likelihood of premature axial translation and leading to additional undesirable displacement positions.

The pharmaceutical reconstitution assembly 100 is inserted into the interior chamber of the body 14 prior to attaching the removable lid 12 to the body 14. During this time, the protrusions 16 and 18 and the wells 20 a-20 c, the wells for the end portions 22 and 24, match the different components of the upper and lower containers 120, 130 included in the drug reconstitution assembly 100 and held within the drug reconstitution assembly 100.

Referring now to fig. 5 and 6, the protrusions and wells are further illustrated. Wells 20a, 20b, and 20c extend outwardly from body 14 and form a substantially coplanar surface upon which drug reconstitution assemblies 100 can be supported. The well 20c is shaped to substantially match the profile shape of the contact port plug 140 of the drug reconstitution assembly 100. In the shipping position, the contact port plug 140 faces downwardly toward the bottom of the assembly to mate with the well 20 c. Engagement of contact port plug 140 with well 20c inhibits rotational movement of the port within body 14. Contact port plug 140 also mates with well 20c to provide additional axial restraint on housing 100 relative to body 14. Orienting the contact port plug 140 downwardly towards the lower end of the assembly 100 prevents a user from removing the drug reconstitution assembly 100 through the contact port plug 140 when peeling back the removable cap 12, which can result in an increased likelihood of accidental separation of the contact port plug 140 from the syringe port. Instead, the contact port plug 140 should be removed just prior to passing through the external syringe connection assembly 100.

Fig. 5 illustrates two protrusions 16 extending inwardly from the package body 14 into the interior chamber of the body. As shown in fig. 6, the protrusion 16 comprises several geometric form parts formed to cooperate with mating parts of the drug reconstitution assembly 100. In particular, each projection 16 includes a plurality of faces, including a first tapered face 16a, a lid side 16b, a body side 16c, an upper face 16d, and a lower face 16 e. As best shown in fig. 1-6, two projections 16 extend from the exterior of the body 14, equally spaced on either side of the longitudinal center of the body 14.

Fig. 2 shows an exploded view of how the pharmaceutical reconstitution assembly 100 fits within the body 14. When the drug reconstitution assembly 100 is inserted into the body 14, the two protrusions 16 extend through the two corresponding apertures 116 of the upper housing portion 112. As shown in fig. 4, the projection 16 extends through the aperture 116 toward the upper receptacle 120. In particular, the body side 16c of the protrusion 16 is constructed and arranged to engage the first contour 116a of the upper housing portion 112 that forms the aperture 116, the lid side 16b of the protrusion 16 is constructed and arranged to engage the side 116b of the upper housing portion 112 that forms the aperture 116, the upper side 16d is constructed and arranged to engage the side 116c of the upper housing portion 112 that forms the aperture 116, and the lower side 16e is constructed and arranged to engage the side 116d of the upper housing portion 112 that forms the aperture 116.

The engagement between the protrusion 16 and the aperture 116 prevents the drug reconstitution assembly 100 from translating axially or rotating within the body 14. In particular, the cover side 16b contacts the side 116b of the upper housing portion 112 forming the aperture 116 and the body side 16c contacts the first contour 116a of the upper housing portion 112 forming the aperture 116 to prevent the drug reconstitution assembly 100 from rotating within the body 14. Similarly, lower face 16e contacts side 116d of upper housing portion 112 forming aperture 116, and upper face 16d contacts side 116c of upper housing portion 112 forming aperture 116 to prevent axial translation of drug reconstitution assembly 100 within body 14.

In various embodiments, the protrusion 16 need not be in continuous contact with the sides 116c and 116d of the well 116 or any contact with the sides 116c and 116d of the well 116 while in physical contact with the upper vial 121 of the upper container 120. It will be appreciated that the protrusion 16 helps to securely retain the upper receptacle 120 within the upper housing portion 112 because the protrusion 16 inhibits any axial displacement of the upper receptacle 120 and any axial displacement of the bore 116 (i.e., the upper housing portion 112) is inhibited by the same protrusion 16. Since the projection 16 extends between the apertures 116 and between the upper neck 122a and upper rim 126 of the upper vial 121 of the upper container 120, the projection 16, and therefore the main body 14, prevents axial displacement of the upper container 120 relative to the upper housing portion 112.

Similar to the projections 16 described above, the body 14 also includes two projections 18 at its lower end, the two projections 18 extending inwardly from the body 14 into the interior chamber of the body. In fig. 6, one of the projections 18 is shown in more detail. Like the protrusion 16, the protrusion 18 includes several geometric features that are sized and arranged relative to the body 14 to cooperate with mating features of the pharmaceutical reconstitution assembly 100 when inserted into the package 10. In particular, the projection 18 includes a second tapered surface 18a, a lid side 18b, a body side 18c, a lower face 18d, and an upper face 18 e. As best shown in fig. 1-6, two projections 18 extend inwardly from the body 14, equally spaced on either side of the longitudinal center of the body 14.

Fig. 2 shows that when the pharmaceutical reconstitution assembly 100 is inserted into the body 14, the two protrusions 18 extend through two corresponding apertures 118 of the lower housing portion 114. As shown in fig. 4, the projection 18 extends through the aperture 118 toward the lower receptacle 130. In particular, the body side 18c of the projection 18 is configured to engage the second contour 118a of the lower housing portion 114 that forms the aperture 118, the cap side 18b of the projection 18 is configured to engage the side 118b of the lower housing portion 114 that forms the aperture 118, the lower face 18d is configured to engage the side 118c of the lower housing portion 114 that forms the aperture 118, and the upper face 18e is configured to engage the side 118d of the lower housing portion 114 that forms the aperture 118.

The engagement between the protrusion 18 and the aperture 118 prevents the drug reconstitution assembly 100 from translating axially or rotating within the body 14. In particular, the cap side 18b contacts the side 118b of the lower housing portion 114 that forms the aperture 118 and the body side 18c contacts the second contour 118a of the lower housing portion 114 that forms the aperture 118 to prevent the drug reconstitution assembly 100 from rotating within the body 14. Similarly, lower face 18d contacts side 118c of lower housing portion 114 forming aperture 118 and upper face 18e contacts side 118d of lower housing portion 114 forming aperture 118 to prevent axial translation of drug reconstitution assembly 100 within body 14.

In various embodiments, the protrusion 18 need not be in continuous contact with the sides 118c and 118d of the well 118 or any contact with the sides 118c and 118d of the well 118 while in physical contact with the lower vial 131 of the lower container 130. It will be appreciated that the protrusion 18 helps to securely retain the lower receptacle 130 within the lower housing portion 114 because the protrusion 18 inhibits any axial movement of the lower receptacle 130 and the same protrusion 18 inhibits any axial movement of the aperture 118 (i.e., the lower housing portion 114). Since the projection 18 extends between the apertures 119 and between the lower neck 132a and lower rim 136 of the lower vial 131 of the lower container 130, the projection 18, and therefore the body 14, prevents axial movement of the lower container 130 relative to the lower housing portion 114.

Thus, the projections 16 and 18 cooperate to prevent both axial and rotational movement of the housing 110 of the drug reconstitution assembly 100 within the package 10. Although illustrated as matching each two apertures 116 and 118 for each two protrusions 16 and 18, other embodiments include matching one corresponding aperture 116 and 118 for each protrusion 16 and 18, or matching more than two corresponding apertures 116 and 118 for more than every two protrusions 16 and 18. It should be appreciated that internal mechanisms and friction in the drug reconstitution assembly 100 are used to secure the upper and lower reservoirs 120, 130 relative to the housing 110 for reasons discussed in more detail in the' 967 application.

In various embodiments, the various internal seals or assemblies described in greater detail in the' 967 application can be compromised if either the upper container 120 or the lower container 130 moves radially about the longitudinal axis of the pharmaceutical reconstitution assembly 100. It should be appreciated that the protrusion 20c, the protrusion 16, and the protrusion 18 cooperate to prevent inadvertent rotational movement of the upper or lower containers 120, 130 within the housing 110, or any other component of the pharmaceutical reconstitution assembly 100 within the package 10.

Referring again to fig. 3-6, the mating relationship between the body 14 and each of the upper vials 121 of the upper container 120 and the lower vials 131 of the lower container 130 is further discussed and illustrated. In addition to the interaction between the protrusion 16 and the aperture 116 of the housing 110 and the protrusion 18 and the aperture 118 of the housing 110 to prevent movement of the housing 110 as described above, the protrusion 16 also matches the different parts of the upper vial 121 and the protrusion 18 also matches the different parts of the lower vial 131 to prevent significant movement of the upper and lower containers 120, 130. For this purpose, both the projections 16 and 18 extend through the respective apertures 116 and 118 to contact the upper vial 121 and the lower vial 131. In various embodiments, axial translation of the upper and lower receptacles 120, 130 with respect to the outer shell 110, and more particularly with respect to the upper and lower housing portions 112, 114, respectively, is prevented by the following engagements, namely: the protrusion 16 engages both the upper vial 121 and the well 116, and the protrusion 18 engages both the lower vial 131 and the well 118.

As described above, the upper and lower containers 120, 130 are arranged such that the respective upper and lower shoulders 122b, 132b, 122a, 132a, 126 and 136 of the upper and lower vials 121, 131 are aligned with each of the apertures 116, 118, respectively. In the illustrated embodiment, the protrusion 16 is configured to contact three different portions of the upper vial 121, namely the upper shoulder 122b, the upper neck 122a, and the upper rim 126. Similarly, the protrusion 18 contacts three different portions of the lower vial 131, namely the lower shoulder 132b, the lower neck 132a and the lower rim 136. Fig. 2 shows that the contact port plug 140 ensures that the holes 116 and 118 are rotated properly to receive the projections 16 and 18, respectively.

The tapered portion 16c of the protrusion 16 of the body 14 is configured to follow the contour of the upper shoulder 122b of the upper vial 121 and thereby retain the upper shoulder 122 b. Likewise, the tapered portion 18c of the projection 18 of the body 14 is configured to follow the contour of the lower shoulder 132b of the lower vial 131 and thereby retain the lower shoulder 132 b. Correspondingly, the first and second tapered faces 16a, 18a also serve to support each of the upper and lower vials 121, 131 so as to prevent significant translational movement of the respective upper and lower containers 120, 130 within the package 10. To prevent the vial from moving to an undesired displacement position, it should be appreciated that in various embodiments, the first and second tapered surfaces 16a, 18a need not contact the contoured upper and lower shoulders 122b, 132 b. Due to the contoured nature of upper and lower shoulders 122b, 132b and the respective tapered shapes of first tapered face 16a, cover side 16b, upper and lower receptacles 120, 130 are urged against the offset relative to body 14 and housing 110. The contoured shape of the body also provides a hugging effect which ensures a snug fit between the upper and lower vials 121, 131 and the body 14.

In various embodiments, the lid side 16b of the protrusion 16 of the main body 14 is arranged to extend towards the upper neck 122a of the upper vial 121 between the upper rim 126 and the upper shoulder 122b of the upper vial 121. The cap side 16b, wedged between the upper rim 126 and the upper shoulder 122b, further serves to prevent translational movement of the upper container 120 within the package 10. Similarly, the cap side 18b of the protrusion 18 is configured to extend toward the lower neck 132a of the lower vial 131 between the lower rim 136 and the lower shoulder 132b of the lower vial 131. Wedging the lid side 18b between the lower edge 136 and the lower shoulder 132b further serves to prevent translational movement of the lower container 130 within the package 10. To prevent the vial from moving to an undesired displacement position, it should be appreciated that in various embodiments, the lid side 16b and the lid side 18b need not be in constant contact with the upper rim 126 and the lower rim 136 and the upper shoulder 122b and the lower shoulder 132 b.

It should be appreciated that while transfer set assembly 200 need not be part of upper housing 112 or lower housing 114, transfer set assembly 200 does remain stationary relative to the housings due in part to the connection of transfer set assembly 200 at the syringe port. It will therefore be appreciated that with similar principles as described above with respect to the upper and lower containers 120, 130 and the housing 100, the body 14 and its projections 16, 18 also function to prevent axial translation of the upper and lower containers 120, 130 relative to the transfer set assembly 200.

Additionally, due to the orientation of the first and second tapers 16a, 18a formed in the body 14, the upper and lower containers 120, 130, if any, are urged away from the transfer set assembly 200. As shown in fig. 4 and 6, the upper and lower shoulders 122b, 132b of the respective upper and lower vials 121, 131 sit on the first and second profiles 116a, 118a, respectively, the first and second profiles 116a, 118a being angled so that in the absence of all other axial obstructions, the upper and lower containers 120, 130 will also be unable to shift inwardly, or toward the transfer set assembly 200, and in particular toward the upper and lower punctures 202, 206, and the lower and lower shields 204, 208, and into an undesirable displaced position. It should be appreciated that the upper and lower containers 120, 130 are prevented from axially translating relative to each other, at least for the same reason that the upper and lower containers 120, 130 are prevented from axially translating relative to the transfer set assembly 200.

The end portion 22 of the body 14 is formed to support and restrain the various components of the pharmaceutical reconstitution assembly 100 when assembled into the package 10. Fig. 4 shows that the end portion 22 of the body 14 is configured to: the upper container 120 is restrained by limiting the upward axial movement of the upper vial 121. The end portion 22 also supports the base portion 122c of the upper vial 121. Similarly, the end portion 24 of the body 14 is configured to: the lower container 130 is restrained by limiting the downward axial movement of the lower vial 131. The end portion 24 also supports the base portion 132c of the lower vial 131. It should be appreciated that some embodiments include a body 14, the tolerances of the body 14 being such that the end portions 22 and 24 contact or nearly contact the respective bottoms of the upper and lower vials 121 and 131, respectively. In various embodiments, end portions 22 and 24 do not contact the bottom of upper vial 121 and lower vial 131, respectively.

It should be apparent from the above discussion that the geometry and components of the formed body 14 interact with the following components at multiple contact locations: (i) a drug reconstitution assembly 100 to prevent rotational and translational movement of the drug reconstitution assembly 100; and (ii) the upper and lower receptacles 120, 130 to prevent the upper and lower receptacles 120, 130 from rotationally and translationally moving to an undesired displacement position.

Aspects of the subject matter described herein can be used alone or in combination with one or more other aspects described herein. Without limiting the above description, in a first aspect of the present disclosure, a medical packaging assembly includes: a drug reconstitution assembly comprising (i) a housing forming at least one aperture, (ii) a container disposed at least partially within an interior of the housing, and (iii) a piercing assembly disposed within the housing so as to be capable of piercing the container; and a body shaped to receive the pharmaceutical reconstitution assembly, the body including at least one protrusion extending through the aperture and into the interior of the housing, wherein the at least one protrusion is positioned and arranged to prevent movement of the container toward the spike assembly until the container reaches an undesired displacement relative to the spike assembly.

According to a second aspect of the present disclosure that may be used in conjunction with the first aspect, the second aspect includes a lid attached to the body and configured to sealingly enclose the pharmaceutical reconstitution assembly within the body.

A third aspect of the disclosure that may be used in combination with any one or more of the above aspects, wherein the lid is attached to the body by a heat activated adhesive.

According to a fourth aspect of the present disclosure that may be used in combination with any one or more of the above aspects, wherein the at least one protrusion is configured to prevent axial translation of the container relative to the housing.

According to a fifth aspect of the present disclosure that may be used in combination with any one or more of the above aspects, wherein the at least one protrusion further prevents the drug reconstitution component from rotating within the body.

According to a sixth aspect of the present disclosure that may be used in combination with any one or more of the above aspects, wherein the body is configured with at least one flat surface in order to prevent the body from rolling.

According to a seventh aspect of the present disclosure that may be used in combination with any one or more of the above aspects, wherein the pharmaceutical reconstitution assembly includes a syringe port plug and the body includes a cavity shaped to mate with the syringe port plug of the pharmaceutical reconstitution assembly.

According to an eighth aspect of the present disclosure that may be used in combination with any one or more of the above aspects, wherein the container is a first container, and the present disclosure includes a second container at least partially disposed within a housing of the pharmaceutical reconstitution assembly, the housing forming at least one second aperture, wherein the at least one protrusion is a first protrusion, and the present disclosure includes a second protrusion positioned and arranged to extend through the second aperture and into an interior of the housing, and the second protrusion preventing movement of the second container toward the spike assembly until the second container reaches an undesired displacement relative to the spike assembly.

According to a ninth aspect of the disclosure that may be used in combination with any one or more of the above aspects, wherein the container is a first vial comprising a neck and a shoulder, the first container being arranged relative to the housing such that at least a portion of the neck of the first vial is aligned with the at least one first aperture, the at least one first protrusion being configured to extend toward the neck and engage the shoulder before the first vial reaches an undesired displacement relative to the spike assembly.

A tenth aspect of the disclosure that may be used in combination with any one or more of the above aspects, wherein the container is a first container, and the disclosure includes a second container disposed at least partially within a housing of the pharmaceutical reconstitution assembly, and the second container is a vial including a neck and a shoulder, the housing forming at least one second aperture, the second container being arranged relative to the housing such that at least a portion of the neck of the second container is aligned with the at least one second aperture, wherein the at least one projection is a first projection, and the body forms a second projection positioned and arranged to extend through the second aperture and into an interior of the housing toward the neck of the second container, and engage the shoulder of the second container before the second container reaches an undesirable displacement relative to the spike assembly.

According to an eleventh aspect of the disclosure, which may be used in combination with any one or more of the above aspects, a drug delivery product comprises: a drug reconstitution assembly comprising a housing and a container disposed within the housing; and a package comprising a body shaped to contain the pharmaceutical reconstitution assembly and at least one protrusion extending from the body positioned and arranged to engage the housing and the container to inhibit axial translation of the container relative to the housing.

A twelfth aspect of the disclosure that may be used in combination with the eleventh aspect, with any one or more of the above aspects, wherein the container is a first container, and the disclosure includes a second container disposed within the housing, the protrusion being a first protrusion, the body including a second protrusion positioned and arranged to engage the housing to inhibit axial translation of the second container relative to the housing.

A thirteenth aspect of the disclosure may be used in combination with the eleventh aspect, with one or more of the above aspects, wherein the first protrusion engages the housing at a first location adjacent the first receptacle, and the second protrusion engages the housing at a second location adjacent the second receptacle.

A fourteenth aspect of the present disclosure that may be used in combination with the eleventh aspect, with one or more of the any of the preceding aspects, wherein the first and second engagements comprise first and second protrusions that extend through first and second apertures, respectively, of the housing.

A fifteenth aspect of the present disclosure that may be used in combination with the eleventh aspect, with one or more of the any of the preceding aspects, wherein there is at least one of: (i) the first aperture is one of a plurality of first apertures radially spaced about the housing, or (ii) the second aperture is one of a plurality of second apertures radially spaced about the housing.

A sixteenth aspect of the present disclosure that may be used in combination with the eleventh aspect, with one or more of the preceding aspects, wherein the first and second protrusions extending through the first and second apertures further inhibit rotational movement of the housing relative to the body.

A seventeenth aspect of the disclosure that may be used in combination with the eleventh aspect, with any one or more of the above aspects, wherein the first and second containers are contacted by a transfer set assembly that includes a port accessible by a user, the body including a well positioned and arranged to engage the port, or including a plug to plug the port, thereby preventing axial movement of the housing.

An eighteenth aspect of the disclosure that may be used in combination with the eleventh aspect, with any one or more of the preceding aspects, wherein the drug reconstitution assembly also inhibits rotational movement of the housing relative to the body by engagement of the at least one protrusion.

According to a nineteenth aspect of the present disclosure that may be used in combination with the eleventh aspect, with any one or more of the above aspects, wherein the drug reconstitution assembly also inhibits axial movement of the housing relative to the body by engagement of the at least one protrusion.

According to a twentieth aspect of the present disclosure, which may be used in combination with any one or more of the above aspects, a method of packaging a pharmaceutical reconstitution assembly comprises: providing a package having a removable lid and a body configured to contain a pharmaceutical reconstitution assembly, the body including at least one protrusion extending from the body; providing a pharmaceutical reconstitution assembly having a housing including at least one aperture and a container at least partially disposed within the housing, wherein a neck portion of the container is aligned with at least one of the apertures of the housing; fitting the pharmaceutical reconstitution assembly within the body of the package such that the at least one protrusion of the body extends through at least one of the apertures of the housing, wherein the orientation of the pharmaceutical reconstitution assembly within the package is limited to a predetermined number of orientations; and sealing the pharmaceutical reconstitution assembly within the body of the package by a removable lid.

It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.

Claims

1. A drug delivery product (10) comprising:

a drug reconstitution assembly (100) comprising a housing (110) and a container (120, 130) disposed within the housing (110); and

a package comprising a body (14) shaped to contain the pharmaceutical reconstitution assembly (100), and at least one protrusion (16, 18) extending from the body (14), the at least one protrusion (16, 18) positioned and arranged to engage the housing (11) and the container (120, 130) through at least one aperture (116, 118) in the housing (110) to inhibit axial translation of the container (120, 130) relative to the housing (110), the aperture comprising a hole having a perimeter completely defined by the housing.

2. The drug delivery product of claim 1, wherein the container is a first container and the drug delivery product comprises a second container disposed within the housing, the at least one protrusion is a first protrusion, the body comprises a second protrusion positioned and arranged to engage the housing to inhibit axial translation of the second container relative to the housing.

3. The drug delivery product of claim 2, wherein the first protrusion engages the housing at a first location adjacent the first container and the second protrusion engages the housing at a second location adjacent the second container.

4. The drug delivery product of claim 2, wherein the at least one aperture comprises first and second apertures, wherein the first and second engagements comprise the first and second protrusions, the first and second protrusions extending through the first and second apertures of the housing, respectively.

5. A drug delivery product according to claim 4, wherein at least one of the following is present: (i) the first aperture is one of a plurality of first apertures radially spaced about the housing, or (ii) the second aperture is one of a plurality of second apertures radially spaced about the housing.

6. The drug delivery product of claim 4, wherein the first and second protrusions extending through the first and second apertures further inhibit rotational movement of the housing relative to the body.

7. A drug delivery product as in claim 2, wherein the first and second containers are contacted by a transfer set assembly comprising a port accessible by a user, the body comprising a well positioned and arranged to engage the port, or a plug to plug the port, thereby inhibiting axial movement of the housing.

8. The drug delivery product of claim 1, wherein the drug reconstitution assembly also inhibits rotational movement of the housing relative to the body by engagement of the at least one protrusion.

9. The drug delivery product of claim 1, wherein the drug reconstitution assembly also inhibits axial movement of the housing relative to the body by engagement of the at least one protrusion.