CN106880494B - Wrapper Components to Prevent Premature Activation - Google Patents

Abstract

The present invention relates to a packaging assembly (10) for preventing premature activation for a drug reconstitution assembly (100), comprising a body (14), a drug reconstitution assembly (100) and a removable cover (12). The body includes a plurality of protrusions (16, 18) configured to mate with corresponding parts of the drug reconstitution assembly to restrain the drug reconstitution assembly and its component parts during shipping and handling Axial and rotational translation. By preventing axial and rotational movement during transport, premature and accidental puncture or contamination of drug or punctures within the drug reconstitution assembly is minimized.

Description

Wrapper Components to Prevent Premature Activation

This application is a divisional application of the Chinese application with the application number 201280070539.3, the application date is February 22, 2012, and the title is "Packaging Components for Preventing Premature Activation".

technical field

The present disclosure relates generally to a medical packaging device assembly, and more particularly to the combination of the packaging and the medical device.

Background technique

Certain drugs are supplied in lyophilized form. Freeze-dried drugs must be mixed with water to reconstitute the drug into a form suitable for injection into the patient. In particular, the components forming the injectable solution must be sterile in order to avoid infection. The reconstitution process presents difficulties for patients or caregivers who need to inject themselves or have someone else inject them, such as in a residential setting. The patient or caregiver must follow the order of the drug container, dilution container and transfer syringe, with the patient or caregiver piercing the stopper associated with the respective container with a needle. Patients or caregivers need to follow established aseptic techniques to avoid contamination.

As described in U.S. Patent Application No. 13/217,967 ("the '967' application"), the disclosure of which is hereby incorporated by reference in its entirety, upon shipment from the manufacturer, distributor, or assembler to the end user, The drug container, dilution container and transfer syringe of the device are mounted in the same housing. Due to the particular arrangement of the transfer syringe relative to each of the drug containers, special care is taken to prevent accidental premature puncture or activation of the container stopper by the transfer syringe during shipping and handling. Shipping of reconstituted devices thus presents challenges in preventing premature activation of the product, ensuring sterility and enabling easy use of the product by the end user. Freeze-dried drugs are often very expensive, making it even more important to minimize accidental activation or contamination during shipping.

Contents of the invention

The present disclosure provides a packaging assembly including a packaging and reconstitution assembly and related medical product that prevents premature activation of the reconstitution assembly. The package is shaped like a reconstituted component in a cradle. The package integrates the relevant parts of the reconstituted assembly and maintains the various parts of the reconstituted assembly isolated from each other in the package during shipping and handling.

In one embodiment, a reconstitution assembly includes a housing having an upper sleeve and a lower sleeve. The housing defines a generally tubular passage and includes a plurality of radially spaced holes in the upper sleeve and a plurality of radially spaced windows in the lower sleeve. The transfer set assembly is arranged in the shell, between the upper casing and the lower casing. The transfer set assembly includes a pair of opposed piercings including a lower piercing and an upper piercing. The upper and lower punctures form part of the flow path.

The first container is disposed at least partially within the upper sleeve of the housing, in the channel and proximate to the upper piercing. The first container includes a first vial and a first stopper, the first stopper providing a sterile barrier to medical contents held within the first vial. In one embodiment, the first container is arranged such that the first cork faces downwards or towards the center of the housing. The second container is disposed within the lower sleeve, in the channel and proximate to the lower puncture. The second container includes a second vial and a second stopper, the second stopper providing a sterile barrier to the contents of the second vial. In one embodiment, the second container is arranged such that the second cork faces upwardly towards the first cork. The flow paths formed by the piercings allow the containers to be in fluid communication with each other when pierced.

In an embodiment, the upper piercing of the transfer set assembly pierces the first cork upon application of the first force to the first container. This force can come from a patient or caregiver squeezing down on the first container, pushing the first container into the housing and onto the upper puncture. After the upper piercing pierces the first cork of the first container, the second container is allowed to move axially relative to the transfer set assembly. The lower piercing of the transfer set assembly then pierces the second vial 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. When the second cork is pierced, a vacuum is entered into the second container. The first and second forces may be predetermined forces, or may be at desired levels.

In an embodiment, the first container encloses the liquid and the second container encloses the lyophilized product. The first cork of the first container is pierced with the upper piercing, and the second cork of the second container is pierced with the lower piercing, so that the first and second containers are 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 container or the second container within the housing. Prevents accidental or premature puncture of the first cork of a first container by an upper puncture or the second cork of a second container by a lower puncture by inhibiting any appreciable axial translation of the first or second container within the housing .

In an embodiment, the package includes an interior chamber formed with a plurality of indentations and protrusions shaped to complement mating components of the reconstitution assembly. The interior chamber of the package is formed such that the recombination 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 cradle the first and second vials of the first and second containers extending from the outer shell of the reconstitution assembly. Protrusions extending into the interior chamber of the package mate with and extend through apertures in the upper sleeve and apertures in the lower sleeve of the housing of the reconstitution assembly.

A hole in the shell allows the protrusion of the package body to extend into the channel formed by the shell, and the hole engages the vial around a portion of the neck of the vial, which can be a vial with a neck opening. The protrusion catches the aperture of the housing to prevent rotation of the first and second respective containers 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 relative to each other and relative to the transfer set assembly, the protrusions of the interior chamber of the package body maintain the upper and lower piercings at a distance from each of the first and second containers, respectively. A separation distance of the container. Since axial translation of components of the reconstitution assembly during shipping and handling is minimized or prevented, premature puncture of the first and second containers by corresponding puncture of the transfer set assembly is also minimized.

Other features and advantages are described herein and will be apparent from the following detailed description and accompanying drawings.

Description of drawings

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

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

3 is a body side view of one embodiment of the assembled packaging and drug reconstitution assembly of the present disclosure.

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

Figure 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 .

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

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

Detailed ways

The present disclosure provides a packaging assembly including an assembled packaging and a reconstitution assembly. Packaging components are particularly useful to prevent premature activation of reconstituted components during shipping and handling. Although packaging components are described herein primarily as including reconstitution components, it should be understood that suitably configured packaging may be used during shipment of other pharmaceutical components or other products having components separated prior to use.

Referring now to the drawings and in particular to FIGS. 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 drug reconstitution assembly 100 (FIG. 2).

Removable cover 12 can be made of any one or more high density polyethylene fibers such as Foil material or paper material, and in one embodiment, removable cover 12 is adhered to main body 14 by heat activated adhesive. The adhesive and application process allows the removable cover 12 to remain securely adhered to the body 14, but is also relatively easily removable by the patient.

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

As shown in FIGS. 1 and 2 , lid 12 is sealingly and removably attached to body 14 , thereby enclosing pharmaceutical reconstitution assembly 100 within package 10 . The removable cover 12 can provide a flat surface on which manufacturer instructions and identifying information can be displayed. Information identifiers can include barcodes, graphic codes, company information, and Internet addresses to direct users to more detailed information. This information may include medical information, patient identifying and prescribing information, manufacturer information, licensing and government agency information, manufacturing and expiration date information, and directions for use.

As shown in FIGS. 1 and 2 , the body 14 is formed to define an interior chamber including a plurality of protrusions 16 and 18 protruding into the chamber, and wells 20 a to 20 c extending 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 cavity of body 14, while a well extends generally away from the interior center of the cavity.

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

Referring now to FIG. 3 , a view of the body side of the assembled package 10 from the outside is shown. The first pair of protrusions 16 and the second pair of protrusions 18 extend from the surrounding surface of the body 14 into the interior cavity to contact mating components of the drug reconstitution assembly 100 . Wells 20 a , 20 b , and 20 c extend outwardly from the interior chamber relative to the surrounding surface of body 14 . Well 20a, well 20b and well 20c are at least substantially flat and coplanar with each other (see also FIGS. On a stable surface, the package 10 can be seated on the main body side. As shown in FIGS. 1 to 3 , the body 14 also forms wells for the end portions 22 and 24 at the upper and lower ends of the body 14 .

Referring now to FIG. 4 , there is illustrated a cross-sectional side view taken along line IV-IV of FIG. 3 . Due to the radial spacing and geometry of the protrusions 16 compared to the radial spacing and geometry of the protrusions 18, the line IV-IV has been exaggerated in FIG. 3 to better show the protrusions in the single view of FIG. 16 and the cross section of both protrusion 18. A cross-sectional view of the reconstitution assembly 100 and its housing 110 illustrates the contents of the reconstitution assembly. Specifically, the 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 hereby incorporated by reference, the transfer set assembly 200 includes an upper piercing 202 , a lower piercing 204 and a flow path that travels through the upper piercing 202 and the lower piercing 204 . The upper piercing 202 faces the first opening 128 of the upper container 120 , while the lower piercing 204 faces the second opening 138 of the lower container 130 . In various embodiments, the plastic portion of the transfer set assembly 200 is made of a suitable moldable and sterilizable plastic, such as acrylonitrile-butadiene-styrene ("ABS"), polycarbonate ( "PC") or acrylic.

Upper piercing 202 can include an upper boot 206 configured to cover and maintain sterility of the lower portion of the upper piercing and the flow path portion of the upper piercing. Similarly, lower piercing 204 includes a lower shield 208 configured to cover and maintain sterility of the upper portion and flow path portion in the lower piercing. In one embodiment, the upper shield 206 and the lower shield 208 are made of an elastomeric material that is easier to be pierced by the upper 202 and lower 204 pierces, respectively, once the drug reconstitution assembly 100 is activated. pierce.

The transfer set assembly 200 can also include a syringe port passageway (as shown in FIG. 2 , under the access port plug 140 ) that is generally perpendicular to the flow path traveling through the upper piercing 202 and the lower piercing 204 and maintained in contact with the piercing. Valved fluid communication of the flow paths that travel through the upper puncture 202 and the lower puncture 204 . The syringe port passage can alternatively extend non-perpendicularly from the flow path of the transfer set assembly 200 . The syringe port passage communicates with a syringe port extending through the housing 110 of the reconstitution assembly 100 . In FIG. 2, contact port plug 140 engages the syringe port to maintain sterility of the fluid pathway in the port and connection.

After fully activating the drug reconstitution assembly 100, the user removes the access port plug 140 to expose the syringe port for user access through a detached syringe. The contact port plug 140 is made of an elastomeric or rubber material so that the contact port plug 140 can be bent for gripping and removal. The syringe port passage and piercing flow path allow for fluid communication from the syringe port to the upper reservoir 120 and the lower reservoir 130 .

Upper container 120 and lower container 130 include upper and lower vials 121, 131, for example, made of suitable medical grade sterilizable glass or plastic. Both upper vial 121 and lower vial 131 are generally cylindrical and have similar geometries, including upper and lower necks 122a, 132a, base portions 122c and 132c, and upper and lower rims 126,136. The upper and lower necks 122a, 132a have a smaller diameter than the base portions 122c, 132c or the upper and lower rims 126, 136. The upper stopper 124 hermetically plugs the first opening 128 of the upper vial 121 , thereby preventing contamination or leakage of the contents of the upper container 120 . Similarly, a lower stopper 134 hermetically plugs the second opening 138 of the lower vial 131 , thereby preventing contamination or leakage of the lower container 130 . The upper cork 124 and the lower cork 134 can be made of rubber or elastomeric material. It should be understood that the assembly of upper vial 121 and upper cork 124 is defined herein as upper container 120 . Similarly, the assembly of lower vial 131 and lower cork 134 is defined herein as lower container 130 .

The housing 110 of the drug reconstitution assembly 100 includes an upper housing portion 112 and a lower housing portion 114, which 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 and the lower housing portion 114 includes or defines a plurality of apertures 118 (as best shown in FIG. 2 ). Both apertures or windows 116 and 118 are radially spaced about a respective housing. Apertures 116 and 118 allow sterile gas to flow to the interior portions and components of drug reconstitution assembly 100 . In addition to ease of sterilization handling, apertures 116 and 118 provide at least partial contact with upper container 120 and lower container 130 when housed in reconstitution housing 110 .

As discussed in more detail in the '967 application, once the drug reconstitution assembly 100 is activated, the upper piercing 202 pierces the upper shield 206 and the upper stopper 124 to access the contents of the upper container 120, after which the lower piercing 204 pierces the lower A protective cover 208 and a lower cork 134 to access the contents of the lower container 130 . When upper punctures 202 and lower punctures 204 have contacted the contents of upper container 120 and lower container 130 , respectively, a flow path is created between upper container 120 and lower container 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 piercing 202 and that the upper cork 124 is closed before the lower piercing 204 can contact the lower cork 134 of the lower container 130. Piercing 202 pierces completely.

4 illustrates how the upper container 120 and the lower container 130 fit in the housing 110 of the drug reconstitution assembly 100 and how the drug reconstitution assembly 100 fits in the interior cavity of the package body 14 during shipping (inactive state). As shown, the upper container 120 at least partially fits within the upper housing portion 112 . Both the upper rim 126 of the upper vial 121 and the upper stopper 124 are oriented towards the transfer set assembly 200 and the upper piercing 202 . In the shown inactive state, the upper cork 124 of the upper container 120 is arranged close to, but not in contact with, the upper piercing 202 .

The upper housing portion 112 in one embodiment includes three apertures 116 radially disposed substantially uniformly about the upper housing portion 112 , as partially shown in FIG. 2 . It should be appreciated that any number of holes 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 transport configuration, various components of the upper vial 121, such as the upper shoulder 122b, upper neck 122a and upper rim 126 are longitudinally aligned with the aperture 116 .

Like upper container 120 , lower container 130 at least partially fits within lower housing portion 114 . Both the lower lip 136 of the lower vial 131 and the lower stopper 134 are oriented toward the lower piercing 204 of the transfer set assembly 200 . In the inactive state (as shown), the lower cork 134 of the lower container 130 is disposed proximate to the lower piercing 204 , but not contacting the lower piercing 204 of the diverter assembly 200 .

The lower housing portion 114 in one embodiment includes six apertures 118 uniformly and radially disposed about the lower housing portion 114 , as partially shown in FIG. 2 . Any number of holes 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 part 114 are visible. Lower housing portion 114 is formed such that various components of lower vial 131 , such as lower shoulder 132b, lower neck 132a and lower rim 136 are longitudinally aligned with aperture 118 when lower container 130 is secured in its transport configuration.

It is important that upper container 120 and lower container 130 not move out of their delivery configurations until drug reconstitution assembly 100 is intentionally activated by a user. Such undesired displacement of the upper container 120 or lower container 130 by shipping, handling, or mishandling can result in premature contact between the upper punctures 202 or lower punctures 204 and the corresponding upper 124 or lower 134 corks. . Even, rupture or interference of the upper shield 206 and the lower shield 208 caused by the respective upper piercings 202 and lower piercings 204 can destroy the sterility of the flow paths traveling through the upper piercings 202 and the lower piercings 204 of the transfer set assembly 200 surroundings. As discussed in more detail below, package 10 prevents these unwanted displacements.

It should be understood that for purposes of this disclosure, undesired displacement defines any one of a number of different resulting positions of the following components, namely: upper container 120 and lower container 130, upper puncture 202 and lower puncture 204, upper cork 124 and lower bottle stopper 134, upper shield 206 and lower shield 208, transfer suit assembly 200 and housing 110. Each of the undesired displacement positions that can occur accidentally during transport are prevented by the interaction of the body 14 with the drug reconstitution assembly 100 . Described below are several undesirable displacement positions. It should be understood that while discussed with respect to both the upper and lower containers, it is contemplated that each of the undesired displacement positions applies to the upper container 120 and the lower container 130 individually or collectively.

In the first undesired displaced position, the upper container 120 or the lower container 130 is axially offset relative to the transfer set assembly 200 such that the upper bottle stopper 124 or the lower bottle stopper 134 is in contact with the upper protective cover 206 or the lower protective cover 208, Either upper shield 206 or lower shield 208 then contacts and is at least partially pierced by upper puncture 202 or lower puncture 204 , respectively. It will be appreciated that in the first undesired displaced position, the respective upper piercing 202 and lower piercing 204 do not fully penetrate the upper cork 124 or the lower cork 134 . In the first undesired displaced position, the upper shield 206 and the lower shield 208 are pierced by the respective upper 202 and lower punctures 204 , making the transfer set assembly 200 and its flow path susceptible to contamination.

In the second undesired displaced position, the upper container 120 or the lower container 130 is moved axially relative to the transfer set assembly 200 such that the upper cork 124 or the lower cork 134 is in contact with 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 piercing 202 or the lower piercing 204 by the axial translation of the respective container. In the second undesired displacement position, either the upper piercing 202 or the lower piercing 204 completely pierces the corresponding upper shield 206 and lower shield 208 and at least partially pierces the upper bottle of the respective upper container 120 and lower container 130 Stopper 124 and lower bottle stopper 134. In a second, undesired displaced position of various embodiments, the upper piercing 202 and the lower piercing 204 completely penetrate the respective upper 124 and lower 134 corks. In the second undesired displacement position, the upper cork 124 or the lower cork 134 is partially or completely pierced by the upper puncture 202 or the lower puncture 204, resulting in a chance of contamination of the transfer set assembly 200 and the upper container 120 or lower container 130. The chance of contamination of the contents increases.

In the third undesired displaced position, the upper container 120 or the lower container 130 is displaced radially or axially relative to the housing 110 , thereby causing a failure of the seal between the upper vial 121 , the lower vial 131 and the interior of the housing 110 . In a third, undesired displacement position, a failed seal can reduce the secure positioning of the upper and lower containers 120, 130 in the housing 110, thereby increasing the likelihood of premature axial translation and causing additional undesired displacements Location.

Prior to attaching the removable cover 12 to the body 14 , the drug reconstitution assembly 100 is inserted into the interior cavity of the body 14 . During this time, the protrusions 16 and 18 and the wells 20a to 20c, the wells for the end portions 22 and 24 are matched to those included in the drug reconstitution assembly 100 and are retained within the drug reconstitution assembly 100 Different components of the upper container 120 and the lower container 130.

Referring now to Figures 5 and 6, the protrusions and wells are further illustrated. Wells 20a, 20b, and 20c extend outwardly from body 14 and form substantially coplanar surfaces upon which drug reconstitution assembly 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 is down towards the bottom of the assembly to match the well 20c. Engagement of the contact port plug 140 with the well 20c inhibits rotational movement of the port within the body 14 . The contact port plug 140 also mates with the well 20c to provide additional axial restraint on the housing 100 relative to the body 14 . Orienting the access port plug 140 downwardly towards the lower end of the assembly 100 prevents the user from removing the drug reconstitution assembly 100 through the access port plug 140 when peeling back the removable cap 12, which could cause the access port plug 140 to dislodge from the syringe. The possibility of accidental port separation increases. Instead, the contact port plug 140 should be removed just prior to connecting the assembly 100 via an external syringe.

Figure 5 illustrates two protrusions 16 extending inwardly from the package body 14 into the interior cavity of the body. As shown in FIG. 6 , the protrusion 16 includes several geometrical features formed to cooperate with mating parts of the drug reconstitution assembly 100 . In particular, each protrusion 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 16e. FIGS. 1 to 6 clearly show that two protrusions 16 extend from the exterior of the body 14 at equal intervals on either side of the longitudinal center of the body 14 .

FIG. 2 shows an exploded view of how drug reconstitution assembly 100 fits within body 14 . When drug reconstitution assembly 100 is inserted into body 14 , two protrusions 16 extend through two corresponding holes 116 of upper housing portion 112 . As shown in FIG. 4 , the protrusion 16 extends through the aperture 116 toward the upper container 120 . In particular, the body side 16c of the protrusion 16 is constructed and arranged to engage the first profile 116a of the upper housing portion 112 forming the aperture 116, and the cover side 16b of the protrusion 16 is constructed and arranged to engage the upper housing forming the aperture 116. The side 116b of the body portion 112, the upper surface 16d are constructed and arranged to engage the side 116c of the upper housing portion 112 forming the aperture 116, and the lower surface 16e is constructed and arranged to engage the side of the upper housing portion 112 forming the aperture 116 116d.

Engagement between protrusion 16 and aperture 116 prevents axial translation or rotation of drug reconstitution assembly 100 within body 14 . In particular, lid side 16b contacts side 116b of upper housing portion 112 forming aperture 116, and body side 16c contacts first contour 116a of upper housing portion 112 forming aperture 116 to prevent drug reconstitution assembly 100 from within body 14. rotate. 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 constant or any contact with the sides 116c, 116d of the aperture 116 while in physical contact with the upper vial 121 of the upper container 120. . It should be appreciated that the protrusion 16 helps to securely hold the upper container 120 within the upper housing portion 112, because the protrusion 16 inhibits any axial deflection of the upper container 120, and the same protrusion 16 inhibits the hole 116 (i.e. , any axial offset of the upper housing portion 112). Since the protrusions 16 extend between the holes 116 and between the upper neck 122a and the upper edge 126 of the upper vial 121 of the upper container 120, the protrusions 16 and thus the body 14 prevent the axis of the upper container 120 relative to the upper housing part 112. offset.

Similar to the protrusions 16 described above, the body 14 also includes at its lower end two protrusions 18 that extend inwardly from the body 14 into the interior cavity of the body. In Fig. 6, one of the protrusions 18 is shown in more detail. Like protrusion 16 , protrusion 18 includes several geometrical features dimensioned and arranged relative to body 14 so as to cooperate with mating parts of drug reconstitution assembly 100 when inserted into package 10 . In particular, the protrusion 18 includes a second tapered face 18a, a lid side 18b, a body side 18c, a lower face 18d and an upper face 18e. As is clear from FIGS. 1 to 6 , two protrusions 18 extend inwardly from the main body 14 , equally spaced on either side of the longitudinal center of the main body 14 .

FIG. 2 shows that when the drug reconstitution assembly 100 is inserted into the body 14, two protrusions 18 extend through two corresponding holes 118 of the lower housing portion 114. As shown in FIG. As shown in FIG. 4 , the protrusion 18 extends through the hole 118 toward the lower container 130 . In particular, the body side 18c of the protrusion 18 is configured to engage the second profile 118a of the lower housing portion 114 forming the aperture 118, and the cover side 18b of the protrusion 18 is configured to engage the second contour 118a of the lower housing portion 114 forming the aperture 118. Side 118b , bottom 18d are configured to engage side 118c of lower housing portion 114 forming aperture 118 , and upper face 18e is configured to engage side 118d of lower housing portion 114 forming aperture 118 .

Engagement between protrusion 18 and aperture 118 prevents axial translation or rotation of drug reconstitution assembly 100 within body 14 . In particular, lid side 18b contacts side 118b of lower housing portion 114 forming aperture 118, and body side 18c contacts second profile 118a of lower housing portion 114 forming aperture 118 to prevent drug reconstitution assembly 100 from within body 14. rotate. 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 constant or any contact with the sides 118c and 118d of the aperture 118 while in physical contact with the lower vial 131 of the lower container 130 . It should be appreciated that the protrusion 18 helps to hold the lower container 130 securely within the lower housing portion 114 because the protrusion 18 inhibits any axial movement of the lower container 130 and the bore 118 (i.e., the lower Any axial movement of the housing portion 114). Since the protrusions 18 extend between the holes 119 and between the lower neck 132a and the lower edge 136 of the lower vial 131 of the lower container 130, the protrusions 18 and thus the body 14 prevent axial movement of the lower container 130 relative to the lower housing part 114. move.

Accordingly, protrusion 16 and protrusion 18 cooperate to prevent both axial and rotational movement of housing 110 of drug reconstitution assembly 100 within package 10 . While every two protrusions 16 and 18 are illustrated as matching every two holes 116 and holes 118, respectively, other embodiments include each protrusion 16 and protrusion 18 matching a corresponding hole 116 and hole 118, or more than every two protrusions. 16 and protrusion 18 mate over two corresponding holes 116 and 118 . It should be appreciated that internal mechanisms and friction in drug reconstitution assembly 100 serve to secure upper and lower containers 120, 130 relative to housing 110 for reasons discussed in greater detail in the '967 application.

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

Referring again to FIGS. 3 to 6 , the matching relationship between the main body 14 and each of the upper vial 121 of the upper container 120 and the lower vial 131 of the lower container 130 is further discussed and illustrated. In addition to the interaction between the protrusion 16 and the hole 116 of the housing 110 and the protrusion 18 and the hole 118 of the housing 110 to prevent the above-mentioned movement of the housing 110, the protrusion 16 also mates with different parts of the upper vial 121 and the protrusion 18 also mates with the lower vial 131 different parts of the container to prevent significant movement of the upper container 120 and the lower container 130. For this purpose, both protrusion 16 and protrusion 18 extend through respective holes 116 and 118 to contact upper vial 121 and lower vial 131 . In various embodiments, axial translation of the upper container 120 and the lower container 130 with respect to the housing 110, and more specifically with respect to the upper housing portion 112 and the lower housing portion 114, respectively, is prevented by engagement of the protrusion 16 with the upper housing portion simultaneously. The engagement of the vial 121 and the hole 116 , and the simultaneous engagement of the protrusion 18 with the lower vial 131 and the hole 118 .

As mentioned above, the upper container 120 and the lower container 130 are arranged such that the respective upper and lower shoulders 122b and 132b, the upper and lower necks 122a and 132a and the upper rim 126 and the lower The rim 136 is aligned with each of the holes 116, 118, respectively. In the illustrated embodiment, protrusion 16 is configured to contact three distinct portions of upper vial 121 , namely upper shoulder 122b , upper neck 122a and upper rim 126 . Similarly, the protrusion 18 contacts three different parts of the lower vial 131 , namely the lower shoulder 132b , the lower neck 132a and the lower rim 136 . Figure 2 shows that contact port plug 140 ensures that bore 116 and bore 118 are properly rotated to receive protrusion 16 and protrusion 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 thus retain the upper shoulder 122b. Likewise, the tapered portion 18c of the protrusion 18 of the body 14 is configured to follow the contour of the lower shoulder 132b of the lower vial 131 and thus retain the lower shoulder 132b. Correspondingly, the first tapered surface 16a and the second tapered surface 18a also serve to support each of the upper vial 121 and the lower vial 131 so as to prevent the respective upper container 120 and the lower container 130 from being visibly separated within the package 10. Panning moves. In order 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, 132b. Due to the contoured nature of the upper and lower shoulders 122b, 132b and the corresponding tapered shapes of the first tapered surface 16a, the lid side 16b, the upper container 120 and the lower container 130 are urged against each other relative to the body 14 and housing 110. offset. The contoured shape of the body also provides a hugging effect which ensures a snug fit between the upper 121 and lower 131 vials and the body 14 .

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

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

Additionally, due to the orientation of the first tapered surface 16a and the second tapered surface 18a formed in the body 14, the upper container 120 and the lower container 130 are urged away from the transfer set assembly 200, if anything. As shown in Figures 4 and 6, the upper shoulder 122b and the lower shoulder 132b of the upper vial 121 and the lower vial 131 respectively sit on the first contour 116a and the second contour 118a, the first contour 116a and the second contour 118a is angled so that in the absence of all other axial obstructions, the upper container 120 and lower container 130 will also not be able to move inwardly, or toward the transfer set assembly 200, and specifically toward the upper piercer 202 and upper shield 206 and The lower piercer 204 and lower shield 208 are offset and into an undesired displaced position. It should be appreciated that upper container 120 and lower container 130 are prevented from axially translating relative to each other for at least the same reasons that upper container 120 and lower container 130 are prevented from axially translating relative to transfer set assembly 200 .

End portion 22 of body 14 is formed to support and constrain the various components of drug reconstitution assembly 100 when assembled into package 10 . FIG. 4 shows that the end portion 22 of the body 14 is configured to constrain the upper container 120 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, end portion 24 of body 14 is configured to constrain lower container 130 by limiting downward axial movement of 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 body 14 toleranced such that end portion 22 and end portion 24 contact or come into close contact with the respective bottoms of upper vial 121 and lower vial 131 , respectively. In various embodiments, end portion 22 and end portion 24 do not contact the bottom of upper vial 121 and lower vial 131 , respectively.

As should be apparent from the foregoing discussion, the geometry and features of the formed body 14 interact at multiple contact locations with: (i) the drug reconstitution assembly 100 to prevent rotational and translational movement of the drug reconstitution assembly 100; and (ii) The upper container 120 and the lower container 130 to prevent the upper container 120 and the lower container 130 from rotationally and translationally moving to an undesired displacement position.

Aspects of the subject matter described herein may be used alone or in combination with one or more other aspects described herein. Without limiting the foregoing, 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) at least partially and (iii) a piercing assembly disposed within the housing so as to be able to puncture the container; and a body shaped to accommodate a drug reconstitution assembly, the body comprising a hole extending through the housing and extending to the housing at least one protrusion in the interior of the at least one protrusion, wherein the at least one protrusion is positioned and arranged to prevent movement of the container towards the piercing assembly until the container achieves an undesired displacement relative to the piercing assembly.

According to a second aspect of the present disclosure usable in conjunction with the first aspect, the second aspect includes a cover attached to the body and configured to hermetically enclose the pharmaceutical reconstitution assembly within the body.

In accordance with a third aspect of the present disclosure which may be used in combination with any one or more of the above aspects, wherein the cover is attached to the body by a heat activated adhesive.

According to a fourth aspect of the present disclosure, usable 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 which 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 assembly from rotating within the body.

According to a sixth aspect of the present disclosure which 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 so as to prevent the body from rolling.

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

According to an eighth aspect of the present disclosure usable 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 a pharmaceutical reconstitution assembly, the housing At least one second hole is formed, 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 hole and into the interior of the housing, and at The second protrusion prevents movement of the second container toward the piercing assembly until the second container reaches an undesired displacement relative to the piercing assembly.

According to a ninth aspect of the present disclosure usable 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 is arranged relative to the housing such that at least a portion of the first The neck of the 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 achieves an undesired displacement relative to the piercing assembly .

According to a tenth aspect of the present disclosure usable 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 the housing of the pharmaceutical reconstitution assembly, and the second The second container is a vial comprising a neck and a shoulder, the outer shell forms at least one second aperture, the second container is arranged relative to the outer shell 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 protrusion is a first protrusion and the body forms a second protrusion positioned and arranged to extend through the second aperture and into the interior of the housing towards the neck of the second container, and at the second The second protrusion engages the shoulder of the second container before the second container achieves an undesired displacement relative to the piercing assembly.

According to an eleventh aspect of the present disclosure which may be used in combination with any one or more of the above aspects, a drug delivery product includes: a drug reconstitution assembly including a housing and a container placed in the housing; and packaging, the The package includes a body shaped to receive the pharmaceutical reconstitution assembly and at least one protrusion extending from the body, the at least one protrusion positioned and arranged to engage the housing and the container to resist axial translation of the container relative to the housing.

According to a twelfth aspect of the present disclosure usable 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 comprises a second container placed within the housing, The protrusion is a first protrusion and the body includes a second protrusion positioned and arranged to engage the housing to resist axial translation of the second container relative to the housing.

A thirteenth aspect according to the present disclosure usable in combination with any one or more of the above aspects in combination with the eleventh aspect, wherein the first protrusion engages the housing at a first position adjacent to the first container, and the second The protrusion engages the housing at a second location adjacent to the second container.

According to a fourteenth aspect of the present disclosure usable in combination with any one or more of the above aspects in combination with the eleventh aspect, wherein the first and second engagements comprise first and second protrusions, said first and second The protrusions extend through the first and second apertures of the housing, respectively.

According to a fifteenth aspect of the present disclosure usable in combination with any one or more of the above aspects in combination with the eleventh aspect, wherein there is at least one of the following: (i) the first holes are radially spaced around the housing One of a plurality of first holes, or (ii) the second hole is one of a plurality of second holes radially spaced around the housing.

According to a sixteenth aspect of the present disclosure usable in combination with any one or more of the above aspects in combination with the eleventh aspect, wherein the first and second protrusions extending through the first and second apertures further prevent the housing from moving relative to the The rotational movement of the subject.

According to a seventeenth aspect of the present disclosure usable in combination with any one or more of the above aspects in combination with the eleventh aspect, wherein the first and second containers are contacted by a transfer set comprising The port of contact, the body includes a well positioned and arranged to engage the port, or includes a plug that plugs the port, thereby preventing axial movement of the housing.

According to an eighteenth aspect of the present disclosure usable in combination with the eleventh aspect with any one or more of the above aspects, wherein engagement of the drug reconstitution assembly by the at least one protrusion also prevents rotational movement of the housing relative to the body.

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

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 reconstituted assembly comprises: providing a package having a removable lid and a body configured to contain A drug reconstitution assembly, the body including at least one protrusion extending from the body; a drug reconstitution assembly having a housing comprising at least one aperture and a container at least partially disposed within the housing, wherein the neck portion of the container is in contact with the aligning at least one of the holes of the housing; assembling the drug reconstitution assembly within the main body of the package so that at least one protrusion of the body extends through at least one of the holes of the housing, wherein the orientation of the drug reconstitution assembly within the package is controlled constrained to a predetermined number of orientations; and sealing the drug reconstitution assembly within the body of the package by means of a removable cover.

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 invention and without diminishing its intended advantages. Therefore, it is intended to cover such changes and modifications in the appended claims.

Claims (9)

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.