Patent Description:
This application is directed to a primary container assembly for storing and dispensing a drug. Specifically, this application relates to a primary container assembly for ensuring sterility of a fluid path from manufacturing, through introduction of the drug in the primary container assembly, and to the end user.

In order to dispense a drug into the subcutaneous tissue, intramuscular tissue, or veins of a patient, a fluid path is required to allow the drug to flow out of a primary container storing the drug and through a needle. As a result, an interface is required between the primary container, fluid path, and needle. To form such a connection, conventional primary containers can have an adaptive end (septum, Luer lock) or other interfacing features. However, when interfacing the primary container with the fluid path, needle, or other components of a dispensing system, sterility of the primary container assembly can be compromised. For example, when interfacing a primary container, fluid path, and needle, the connection point between each of these components can have compromised sterility during or after connection, thus leading to a loss of sterility of the system. This can necessitate swabbing of various fittings with alcohol wipes prior to connection to mitigate or minimize risk, leading to greater process complexity. Additionally, such interfacing efforts often require an arrangement of several unique and specially designed interface features that further increase the components through which sterility can be compromised, as well as increase costs and complexity associated with assembling a dispensing device with the goal of ensuring end-to-end sterility.

As a result, there is a need for a primary container assembly having decreased complexity that ensures end-to-end sterility in a drug loading and dispensing process.

<CIT> describes a syringe assembly for a drug delivery device. The syringe assembly includes a syringe barrel having a proximal end, a distal end, and a longitudinal axis. A needle assembly is operatively coupled to the syringe barrel and includes a needle hub and a needle attached to the needle hub. A flexible connection is disposed between the syringe barrel and the needle hub and forms a fluid pathway between the syringe barrel and the needle. The flexible connection enables the needle assembly to be moveable from a filling position, in which a longitudinal axis of the needle assembly is parallel to a longitudinal axis of the syringe barrel, to an assembled position, in which the longitudinal axis of the needle assembly is not parallel to the longitudinal axis of the syringe barrel.

The invention to which this European patent relates is defined in the appended claims.

An example described herein is a primary container assembly comprising a primary container defining a body having a proximal end defining an opening configured to receive a plunger, a distal end opposite the proximal end and defining an outlet, and a chamber extending from the proximal end to the distal end that is configured to receive a drug. The primary container assembly further comprises a tube extending from a first end that is integrally attached to the distal end of the primary container to a second end opposite the first end, where the tube defines a channel extending from the first end to the second end. The primary container assembly also comprises a hollow needle configured to penetrate skin of a patient, wherein the hollow needle is integrally attached to the second end of the tube, where the tube is configured to direct the drug from the chamber of the primary container to the needle.

Also described herein is a method for assembling a primary container assembly. The method includes providing a primary container defining a body having a proximal end defining an opening configured to receive a plunger, a distal end opposite the proximal end and defining an outlet, and a chamber extending from the proximal end to the distal end that is configured to receive a drug. The method further includes attaching a first end of a tube to the distal end of the primary container, such that the tube is in fluid communication with the outlet, and attaching a hollow needle to a second end of the tube.

The foregoing summary, as well as the following detailed description, will be better understood when read in conjunction with the appended drawings. The drawings show illustrative embodiments of the disclosure. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown.

Described herein are primary container assemblies <NUM>, <NUM>' for storing and dispensing a supply of a drug. Certain terminology is used to describe the primary container assemblies <NUM>, <NUM>' in the following description for convenience only and is not limiting. The words "right", "left", "lower," and "upper" designate directions in the drawings to which reference is made. The words "inner" and "outer" refer to directions toward and away from, respectively, the geometric center of the description to describe primary container assemblies <NUM>, <NUM>' and related parts thereof. The words "forward," "rearward," "proximal," and "distal" refer to directions toward or away the proximal or distal ends of body of the component of the primary container assemblies <NUM>, <NUM>' being referred to. The terminology includes the above-listed words, derivatives thereof and words of similar import.

An embodiment of the present disclosure comprises a primary container assembly <NUM> configured to store and deliver a supply of a drug. The primary container assembly <NUM> can include a primary container <NUM>, plunger <NUM>, tube <NUM>, needle <NUM>, needle hub <NUM>, needle <NUM>, needle shield <NUM>, cup <NUM>, and/or second cup <NUM>, each of which will be described in detail below. Referring to <FIG>, the primary container <NUM> can define a body <NUM> that extends from a proximal end 24a to a distal end 24b opposite the proximal end 24a, where the body <NUM> can be comprised of a plastic, such as cyclic olefin or other medical grade plastic, or glass. The body <NUM> can define a substantially elongate, cylindrical shape, though other shapes are contemplated. In one embodiment, the primary container <NUM> is configured as a syringe as described in International Patent Application No. <CIT>, assigned to West Pharmaceutical Services, Inc. of Exton, PA, though the present disclosure is not intended to be limited to such. The body <NUM> of the primary container <NUM> further defines a chamber <NUM> extending from the proximal end 24a to the distal end 24b, where the chamber <NUM> is configured to receive and store a supply of a drug, and from which the drug is ultimately dispensed, as will be described below.

The proximal end 24a of the primary container <NUM> can define a flange to enable easier grasping or ensure proper positioning of the primary container <NUM> within a dispensing device. The proximal end 24a can also define an opening <NUM> configured to provide access to the chamber <NUM>. Likewise, the distal end 24b can define an outlet <NUM> configured to further provide access to the chamber <NUM>. The opening <NUM> can define a diameter that is larger than a diameter of the outlet <NUM>, such that the opening <NUM> is configured to receive a plunger <NUM>. In operation, the chamber <NUM> can be filled from a drug source (not shown) through the opening <NUM>. The plunger <NUM> can be disposed within the chamber <NUM> after the chamber <NUM> has been filled so as to prevent drug from leaking out of the chamber <NUM> through the opening <NUM>. Further, in operation the plunger <NUM> can be translated distally through the chamber <NUM> while sealingly engaging the inner surface of the body <NUM> so as to force the drug from the chamber <NUM> through the outlet <NUM> while maintain a fluid seal with the primary container <NUM>. The plunger <NUM> can comprise a conventional rubber or plastic plunger, though other embodiments are contemplated. The plunger <NUM> can be operably attached to an actuation mechanism (not shown) for selectively translating the plunger <NUM> through the chamber <NUM>, where the actuation mechanism can comprise a motor, spring, pneumatic device, telescoping assembly, or other means capable of causing linear actuation. In one embodiment, the distal end 24b of the primary container <NUM> comprises a Luer connection, though the distal end 24b can include any structure capable of interfacing with a length of tube <NUM>, which will be described further below.

Referring to <FIG>, the tube <NUM> of the primary container assembly <NUM> will be described in greater detail. The tube <NUM> can have a body <NUM> that extends from a first end 64a to a second end 64b opposite the first end 64a. The body <NUM> can define a channel <NUM> extending therethrough from the first end 64a to the second end 64b, such that the body <NUM> is substantially configured as a hollow tube. The body <NUM> can be comprised of a medical grade plastic, metal, such as steel or nitinol, etc., though the present disclosure is not intended to be limited to such. In one embodiment, the body <NUM> is substantially rigid, and as a result defines a fixed shape. In another embodiment, the body <NUM> is flexible, and as a result can be reconfigured and reshaped by a manufacturer or user as desired. For example, the tube <NUM> can be coiled during initial packaging and uncoiled during end use. To place the tube <NUM> in the coiled configuration, the tube <NUM> can be sequentially wrapped around an extension <NUM> of the primary container <NUM> so as to cause at least a portion of the tube <NUM> to take a coiled configuration comprising a plurality of axially arranged coils. A cup <NUM> can be placed over the coiled portion of the tube <NUM> to secure the tube <NUM> in the coiled configuration, as will be described below. However, in other embodiments the cup <NUM> can also comprise a portion of the body <NUM> of the primary container <NUM> (molded together or as an attachment).

As shown in <FIG>, the first end 64a of the tube <NUM> can be integrally attached to the distal end 24b of the primary container <NUM>. Specifically, the distal end 24b of the primary container <NUM> can include an extension <NUM> extending distally therefrom, where the extension <NUM> can comprise one or more concentrically arranged hollow cylindrical necks. For example, in the depicted embodiment the extension <NUM> comprises an inner neck 36a and an outer neck 36b concentrically positioned around the inner neck 36a, though other embodiments are contemplated. The inner neck 36a of the extension <NUM> can define the portion of the distal end 24b that defines the outlet <NUM>. In one embodiment (<FIG>), the extension <NUM> of the primary container <NUM> can be molded over the first end 64a of the tube <NUM>. In another embodiment, the first end 64a of the tube <NUM> can be integrally attached to a Luer connection (not shown) of the primary container <NUM>. Optionally, the extension <NUM> of the primary container <NUM> can be molded over a portion of a needle <NUM> (<FIG>), where the first end 64a of the tube <NUM> is configured to engage another portion of the needle <NUM>. As a result, the needle <NUM> can define an interface between the primary container <NUM> and the tube <NUM>. It is contemplated that the tube <NUM> can be irremovably attached to the primary container <NUM>. It is also contemplated that the primary container <NUM> and tube <NUM> can be formed such that the primary container <NUM> and tube <NUM> define a one-piece, monolithic structure, such as through co-injection molding. In another embodiment, an interface component (not shown) can be attached to the first end 64a of the tube <NUM>, where the interface component is configured to snap onto or frictionally engage the distal end 24b of the primary container <NUM>.

The second end 64b of the tube <NUM> can be integrally attached to a needle hub <NUM> that defines an interface between a hollow needle <NUM> and the tube <NUM>. Though depicted as a hollow needle, it is contemplated that in other embodiments the needle <NUM> can be replaced with a rigid or soft cannula. The needle <NUM> can comprise an elongate, hollow metal needle, though other configurations are contemplated. For example, the body of the needle <NUM> can define a <NUM>-degree angle in some embodiments, or any other angle desired. The needle <NUM> can define a body <NUM> that extends from a first end 104a to a second end 104b opposite the first end 104a. The second end 104b of the hollow needle <NUM> can be configured to penetrate skin of a patient, i.e., administer the drug from the chamber <NUM> of the primary container <NUM> to the patient. As such, the second end 104b can define a sharp tip. Whereas the primary container <NUM> is attached to the first end 64a of the tube <NUM>, the first end 104a of the needle <NUM> is attached to the second end 64b of the tube <NUM>. Due to the inclusion of the tube <NUM>, in this configuration the number of materials used to create the fluid path is minimized, thus eliminating multiple adhesive joints. Further, this design provides the ability to place the needle <NUM> anywhere on the delivery device without any structural constraints related to the primary container <NUM>.

The primary container assembly <NUM> can further include a needle hub <NUM> attached to the needle <NUM>. The needle hub <NUM> can have a body <NUM> defining an outer surface 82a, as well as a channel <NUM> extending therethrough. The second end 64b of the tube <NUM> is configured to be secured at least partially within the channel <NUM> of the needle hub <NUM>. Additionally, the hollow needle <NUM> is configured to be secured at least partially within the channel <NUM>. It is contemplated that in some embodiments, the needle <NUM> can be at least partially received within the channel <NUM> of the tube <NUM>.

A first embodiment of a needle hub <NUM> is shown in <FIG>, <FIG>, while a second embodiment of a needle hub <NUM>' is shown in <FIG>. The body <NUM> of the needle hub <NUM> can extend substantially coaxially along a singular axis. Further, a portion of the body <NUM> can be frustoconical in shape, the function of which will be described below. For example, the body <NUM> of the needle hub <NUM> can define a first section 83a at the proximal end of the body <NUM>, and a second section 83b extending distally from the first section 83a. The first section 83a can define a substantially elongate tube, while the second section 83b can have a frustoconical shape. In contrast, the needle hub <NUM>' can have a portion that extends at substantially a <NUM>-degree angle relative to another portion of the needle hub <NUM>'. It is contemplated that the needle hubs <NUM>, <NUM>' can be irremovably attached to the tube <NUM>. The different shapes of the needle hubs <NUM>, <NUM>' can be configured to create particular interferences with primary container assembly components or components of the device within which the primary container assembly <NUM>, <NUM>' is to be received.

As shown in <FIG>, the tube <NUM> can define a first length L<NUM> measured along an axis coaxial with the body <NUM> of the tube <NUM> from the first end 64a to the second end 64b. Likewise, the needle <NUM> can define a second length L<NUM> measured from its base to its skin-piercing tip, where the first length L<NUM> is greater than the second length L<NUM>. Optionally, the first length L<NUM> can be two times, three time, four times, etc. greater than the second length L<NUM>.

As described above, the primary container assembly <NUM> is configured to cause, under force applied by the plunger <NUM>, the drug to flow from the chamber <NUM> of the primary container <NUM>, through the tube <NUM>, through the needle hub <NUM> and needle <NUM>, and into the patient. The configuration of the primary container <NUM>, tube <NUM>, and needle <NUM> as an integral assembly creates ensured sterility of the drug environment throughout transportation and initial setup of the primary container assembly <NUM> at the end use site. In conventional primary containers, the primary container must be fluidly attached to other components of a dispensing system through complicated and time intensive processes at the end use site, potentially compromising the sterility of the fluid pathway. The primary container assembly <NUM> provides a singular fluid path with greatly increased risks for compromised sterility.

To further ensure fluid pathway sterility and prevent unintended injury from contact with the needle <NUM>, the primary container assembly <NUM> can include a needle shield <NUM> disposed over at least a portion of the needle <NUM> and releasably connected to the needle hub <NUM>. Referring to <FIG>, the needle shield <NUM> can have a body <NUM> that extends from a first end 114a to a second end 114b opposite the first end 114a. It is contemplated that the needle shield <NUM> can be comprised of a soft or rigid material. For example, the body <NUM> of the needle shield <NUM> can be comprised of rubber, though other types of materials are contemplated. The needle shield <NUM> can define a cavity <NUM> extending into the body <NUM> from the first end 114a, where the cavity <NUM> terminates at a location axially between the first and second ends 114a, 114b. In operation, the cavity <NUM> can be sized to receive a portion of the needle <NUM> and at least a portion of the needle hub <NUM> so as to cover the needle <NUM>, thus ensuring sterility of the needle <NUM> and preventing injury from human contact with the second end 104b of the needle <NUM>.

When disposed within the cavity <NUM>, a portion of the needle hub <NUM> can frictionally engage the needle shield <NUM> so as to secure the needle shield <NUM> to the needle hub <NUM>. For example, the second section 83b (the frustoconical portion) can frictionally engage the needle hub <NUM>. When the needle hub <NUM> is inserted into the cavity <NUM>, a progressively increasing diameter of the second section 83b of the needle hub <NUM> can come into contact with the needle shield <NUM>, thus leading to an eventual frictional engagement with the needle shield <NUM>. Additionally, the cavity <NUM> can be designed so as to ensure that a predetermined exposure length of the needle <NUM> is maintained throughout transportation of the needle assembly <NUM>. By maintaining a predetermined length of the needle <NUM> in contact with the needle shield <NUM> through transportation, the primary container assembly <NUM> can ensure sterility of the needle <NUM> is maintained and the needle <NUM> does not repeatedly impact the needle shield <NUM> during transportation, which may otherwise create material fragments.

Referring to <FIG>, the primary container assembly <NUM> can further include a cup <NUM> attached to the distal end 24b of the primary container <NUM>. The cup <NUM> can have a substantially hollow body <NUM> that extends from an open proximal end 134a to a substantially closed distal end 134b. Specifically, the proximal end 134a can define an opening <NUM>, and the body <NUM> defines a cavity <NUM> extends into the body <NUM> from the opening <NUM>. The proximal end 134a can be configured to releasably attach to the distal end 24b of the primary container <NUM>. In one embodiment, the cup <NUM> can be frictionally attached to the primary container <NUM>. However, it is contemplated that the cup <NUM> can be attached to the primary container <NUM> through a snap fit, threaded engagement, label applied or shrink-wrapped to the primary container <NUM> and cup <NUM>, etc. When attached to the primary container <NUM>, the cup <NUM> can be disposed at least partially over the tube <NUM> when the tube <NUM> is in the coiled configuration. As a result, when the tube <NUM> is placed in the coiled configuration, the tube <NUM> can be substantially received within the cavity <NUM> of the cup <NUM>. This can function to keep the tube <NUM> in the coiled configuration throughout transportation until the primary container assembly <NUM> is unpackaged for filling or use.

Once the needle shield <NUM> is attached to the needle hub <NUM>, the cup <NUM> can be utilized to secure the needle shield <NUM> to the primary container <NUM>. As shown in <FIG>, the cup <NUM> can include an extension <NUM> extending from its distal end 134b, where the extension <NUM> defines a channel <NUM> extending therethrough. When the cup <NUM> is placed over the portion of the tube <NUM> in the coiled configuration and releasably attached to the primary container <NUM>, the needle hub <NUM> and at least a portion of the tube <NUM> attached thereto can be fed through the channel <NUM> of the extension <NUM>, at which point the needle shield <NUM> can be disposed over the needle hub <NUM> and the needle <NUM>. The needle shield <NUM> can further be releasably secure to the cup <NUM>, and in particular the extension <NUM> of the cup <NUM>. The needle shield <NUM> can be releasably attached to the cup <NUM> through a snap fit, threaded engagement, label applied or shrink-wrapped to the needle shield <NUM> and cup <NUM>, etc..

Once the primary container assembly <NUM> has reached the final assembly, the components can be unpackaged as follows. First, the needle shield <NUM> can be detached from the cup <NUM> and the needle hub <NUM>. Then, the cup <NUM> can be detached from the primary container <NUM> and removed from placement over the tube <NUM> in the coiled configuration. At this point, the user can be free to transition the tube <NUM> from the coiled configuration to an uncoiled configuration, in which the tube <NUM> is uncoiled from around the distal end 24b of the primary container, particularly the extension <NUM> of the primary container <NUM>.

Though the primary container assembly <NUM> is depicted and described as including the cup <NUM> for securing the tube <NUM> in the coiled configuration, it is contemplated that in other embodiments other devices can be utilized for this purpose. For example, it is contemplated that circumferential grooves (for example, spiraling threads) can be defined by the extension <NUM>, where the tube <NUM> can be coiled around the extension <NUM> such that the tube <NUM> is fitted within the grooves to secure the tube <NUM> to the extension <NUM>. In this or other configurations, the cup <NUM> may or may not be included.

<FIG> depicts a primary container assembly <NUM> including a single cup <NUM> utilized to secure the tube <NUM> in the coiled configuration and the needle shield <NUM> to the primary container <NUM>. However, as shown in <FIG>, another embodiment of a primary container assembly <NUM>' is depicted that includes a second cup <NUM>. The primary container assembly <NUM> has many similar features as the primary container assembly <NUM>', and such features will be similarly labeled and not described herein for brevity. The second cup <NUM> can have a body <NUM> defining an open first end 164a and a substantially closed second end 164b opposite the first end 164a. Specifically, the first end 164a can define an opening <NUM>, and the body <NUM> defines a cavity <NUM> extends into the body <NUM> from the opening <NUM>. The first end 164a can be configured to releasably attach to the distal end 134b of the cup <NUM>. In one embodiment, the second cup <NUM> can be frictionally attached to the first cup <NUM>. However, it is contemplated that the second cup <NUM> can be attached to the cup <NUM> through a snap fit, threaded engagement, label applied or shrink-wrapped to the cup <NUM> and second cup <NUM>, etc. Alternatively, the cup <NUM> and second cup <NUM> can be formed as a monolithic body. In such an embodiment, the cup <NUM> and second cup <NUM> can be formed with breakable members at their interface for manual separation of the cup <NUM> and second cup <NUM>.

When attached to the cup <NUM>, the second cup <NUM> can be disposed at least partially over the needle shield <NUM> when the tube <NUM> is in the coiled configuration. Additionally, the second cup <NUM> can be disposed at least partially over the needle hub <NUM> and needle <NUM> when the needle <NUM> is received within the needle shield <NUM>. The second cup <NUM> can function to secure the needle shield <NUM> during transport of the primary container assembly <NUM>' and offer further protection to the sterility of components of the primary container assembly <NUM>'. Though embodiments of a primary container assembly <NUM>, <NUM>' including cup <NUM> and/or second cup <NUM> are shown and described in relation to <FIG>, it is contemplated that in other embodiments of a primary container assembly, no such cups may be included. One benefit of the embodiment shown in <FIG> is the symmetry of the primary container assembly <NUM>' about its central axis, which provides certain benefits during filling, handling, and inspection of the primary container <NUM>. For example, the second cup <NUM> is configured to interface with a conventional filling machine.

The primary container assemblies <NUM>, <NUM>' can be advantageous in that they define a relatively constant mass about their longitudinal central axis, which allows them to be filled and inspected in conventional ways. For example, the primary container assemblies <NUM>, <NUM>' can be rotated at a high RPM during camera inspection of the drug contents. Such processes would be difficult with a non-symmetric mass around the longitudinal central axis, especially one that allows the needle to be biased away from the central axis line of the primary container.

Referring to <FIG>, a schematic diagram is depicted of a dispensing device <NUM> configured to dispense a drug. For example, the dispensing device <NUM> can be a wearable injection device, handheld injection device, or type of device capable of injecting a drug into a patient, though other types of devices are also contemplated. As shown in <FIG>, the dispensing device <NUM> can be configured to utilize the primary container assembly <NUM>, <NUM>' as the source for the drug. In one embodiment, the primary container assembly <NUM>, <NUM>' can be manually loaded into the dispensing device <NUM> by the end user (after removing needle shield <NUM>, cup <NUM>, and/or second cup <NUM>, as described above). Alternatively, the dispensing device <NUM> can be pre-loaded with components of the primary container assembly <NUM>, <NUM>' by the manufacturer of the dispensing device <NUM>.

The dispensing device <NUM> can include a body <NUM> configured to at least partially receive and secure components (such as the primary container <NUM>, plunger <NUM>, tube <NUM>, and needle hub <NUM>) of the primary container assembly <NUM>, <NUM>'. As such, the body <NUM> can be at least partially hollow. The dispensing device <NUM> can further include an input <NUM> configured to engage the needle hub <NUM> and/or needle <NUM> when components of the primary container assembly <NUM>, <NUM>' are installed within the body <NUM> of the dispensing device <NUM>. This engagement can be such that the tube <NUM> is in fluid communication with the input <NUM>. The dispensing device <NUM> can also include an output component <NUM> in fluid communication with the input <NUM>. The output component <NUM> can be a needle or cannula configured to pierce the skin of a patient, though other output components are contemplated. Alternatively, it is contemplated that the dispensing device <NUM> can include no output component <NUM>, and rather the needle <NUM> of the primary container assembly <NUM>, <NUM>' can function as the output component. In operation, when the components of the primary container assembly <NUM>, <NUM>' are received within the dispensing device <NUM>, the needle hub <NUM> and/or the needle <NUM> can releasably engage the input <NUM>. For example, the engagement can comprise an interference fit, threaded engagement, snap-fit, etc., though other types of attachment are also contemplated. When the needle hub <NUM> and/or the needle <NUM> are engaged with the input <NUM>, the dispensing device <NUM> can be configured to selectively dispense the drug from the primary container <NUM>, through the tube <NUM>, through the needle hub <NUM> and needle <NUM> and into the input <NUM>, from the input <NUM> to the output component <NUM>, and out of the output component <NUM> to the patient. A benefit of utilizing the primary container assembly <NUM>, <NUM>' is that the dispensing device <NUM> does not require sterilization prior to attachment of the primary container assembly <NUM>, <NUM>', as may be the case in other dispensing devices. This is because the fluid path defined by the primary container assembly <NUM>, <NUM>' maintains sterility throughout assembly.

Referring to <FIG>, a method <NUM> for assembly of the primary container assembly <NUM>, <NUM>' is depicted. Method <NUM> can begin with step <NUM>, which includes providing the primary container <NUM>, where the primary container <NUM> defines a body <NUM> having a proximal end 24a defining an opening <NUM> configured to receive a plunger <NUM>, a distal end 24b opposite the proximal end 24a and defining an outlet <NUM>. The primary container <NUM> also defines a chamber <NUM> extending from the proximal end 24a to the distal end 24b and is configured to receive a drug. Step <NUM> can include attaching a first end 64a of the tube <NUM> to the distal end 24b of the primary container <NUM>, such that the tube <NUM> is in fluid communication with the outlet <NUM>. Step <NUM> can comprise molding the distal end 24b of the primary container <NUM> over the first end 64a of the tube <NUM>. Step <NUM> can further comprise monolithically forming the tube <NUM> and the primary container <NUM>. After step <NUM>, in step <NUM> a hollow needle <NUM> can be attached to the second end 64b of the tube <NUM>. Then, in step <NUM>, the primary container <NUM> can be filled with the drug.

Referring to <FIG>, the primary container assembly <NUM>, <NUM>' can be configured to interface with a nest assembly <NUM>. Specifically, the nest assembly <NUM> can define a plurality of apertures <NUM> configured to receive a respective one of the primary container assemblies <NUM>, <NUM>'. As shown particularly with respect to <FIG>, which a primary container assembly <NUM>, <NUM>' is received by the nest assembly <NUM> in a position where the primary container assembly <NUM>, <NUM>' is oriented for filling with a medicament, none of the tube <NUM>, needle shield <NUM>, cup <NUM>, or other related components interfere with the nest assembly <NUM> or the orientation of the primary container assembly <NUM>, <NUM>' generally.

Claim 1:
A primary container assembly, comprising:
a body (<NUM>) having:
a proximal end (24a) defining an opening (<NUM>) configured to receive a plunger (<NUM>);
a distal end (24b) opposite the proximal end (24a) and defining an outlet (<NUM>); and
a chamber (<NUM>) extending from the proximal end (24a) to the distal end (24b) that is configured to receive a drug;
a tube (<NUM>) extending from a first end (64a) that is integrally attached to the distal end (24b) to a second end (64b) opposite the first end (64a), wherein the tube (<NUM>) defines a channel (<NUM>) extending from the first end (64a) to the second end (64b);
a hollow needle (<NUM>) configured to penetrate skin of a patient, wherein the hollow needle (<NUM>) is integrally attached to the second end (64b) of the tube (<NUM>); and
wherein the tube (<NUM>) is configured to direct the drug from the chamber (<NUM>) to the hollow needle (<NUM>),
characterised in that
the primary container assembly further comprises a cup (<NUM>) attached to the distal end (24b) and
wherein the tube (<NUM>) is configured to be placed in a coiled configuration, in which a portion of the tube (<NUM>) is coiled around a portion of the distal end (24b) and substantially disposed within the cup (<NUM>).