Patent Description:
The inventors have appreciated that, with some drug delivery devices, a user may be required to attach and/or detach a needle from the drug delivery device prior to and/or after use. The inventors have recognized a need for an arrangement that facilitates attachment and detachment of a needle assembly from the drug delivery device.

<CIT> discloses a pen needle assembly for use with a medical injector containing an injector body and a reservoir sealed by a septum encased in the injector body. The pen needle assembly includes a hub and a needle fixed to the hub. The hub is formed to be telescopingly mounted onto the distal end of the injector body using a track that accommodates a guide key. When mounting the pen needle assembly onto the injector body, a first portion of the track is configured to receive the guide key and to guide the guide key in a straight line across sufficient distance to permit the proximal end of the needle to fully pierce through the septum, without rotation of the needle. A second portion of the track is configured to permit the pen needle assembly to be turned with the proximal end of the needle being located proximally of the septum.

<CIT> discloses an auto-injector that confines all functional components inside an enclosed housing, to keep its needle out-of-sight, at all times. Within the housing, a needle holder positions a needle at a location. A drive mechanism then simultaneously engages the needle with a fluid source and accelerates it with a predetermined momentum for insertion into a patient. After fluid delivery, the withdrawn needle is moved to storage within the housing for subsequent disposal.

<CIT> discloses a continuous syringe with automatic replacing needles, comprising a rotatable revolver-type needle magazine.

<CIT> discloses a device for administering injections. The device includes a housing having an upper end, a lower end including a bottom surface with an injection needle opening, and an axis extending between the upper and lower ends. The device also includes an injection needle disposed within the housing for moving between a retracted position and an extended position.

Further aspects and preferred embodiments of the invention are defined in the dependent claims.

Other advantages and novel features of the present invention will become apparent from the following detailed description of various non-limiting embodiments of the invention when considered in conjunction with the accompanying figures. In cases where the present specification and a document referred to include conflicting and/or inconsistent disclosure, the present specification shall control.

Additional embodiments of the disclosure, as well as features and advantages thereof, will become more apparent by reference to the description herein taken in conjunction with the accompanying drawings. The components in the figures are not necessarily to scale. Moreover, in the figures, like-referenced numerals designate corresponding parts throughout the different views.

The present disclosure relates to drug delivery devices having needle assemblies that are removably attachable to another portion of the drug delivery device. This other portion of the drug delivery device will be referred to herein as a drug device, while the combination of the needle assembly with the drug device will be referred to herein as a drug delivery device. A drug device includes the portion of the drug delivery device that contains or is configured to contain a medicament.

In one aspect, a needle assembly is configured to be attached to a drug device by a user without requiring the user to contact and/or view the needle of the needle assembly.

In another aspect, a needle assembly is configured to be removed from a drug device by a user without requiring the user to contact the needle of the needle assembly, and in some embodiments, without requiring the user to view the needle of the needle assembly.

As discussed above, in some embodiments, the drug device portion of the drug delivery device may contain a medicament. The term "medicament" refers to one or more therapeutic agents including but not limited to insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-<NUM> receptor agonists such as dulaglutide or liraglutide , glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies and any therapeutic agent that is capable of delivery by the above device. The medicament as used in the device may be formulated with one or more excipients. The device is operated in a manner generally as described herein by a patient, caregiver or healthcare professional to deliver medicament to a person.

An illustrative embodiment of a drug delivery device is shown in <FIG>, with an exploded view of the drug delivery device shown in <FIG>. The drug delivery device <NUM> may include a needle assembly <NUM>, a drug device <NUM>, and a medicament container <NUM>. In some embodiments, the needle assembly and the medicament container are disposable components. The needle assembly may be configured to be used only once and replaced each time. In other embodiments, however, all of or portions of the needle assembly may be re-used. In some embodiments, the medicament container may be used to deliver medicament multiple times, as in a multi-dose arrangement. In other embodiments, the medicament container is configured to deliver all of its contents in a single dose. In some embodiments, all or portions of the drug device may be durable component(s) that may be reused many times. In other embodiments, however, the drug device is a single-use disposable component.

In some embodiments, as shown in <FIG>, the medicament container <NUM> is formed as a generally cylindrical body having a septum <NUM> at a distal end thereof, an interior volume <NUM> to hold the medicament prior to dispensing, and a piston <NUM> disposed in the interior volume at a proximal end of the container <NUM> and moves distally through the interior volume <NUM> toward the septum <NUM> to expel medicament out of the medicament container. In some embodiments, a portion of a container drive for moving the piston may be part of the medicament container <NUM>. In one embodiment, the piston <NUM> is driven by a container drive. In the embodiment of <FIG>, such a container drive includes a first portion <NUM> located at a proximal end of the medicament container and, as will be discussed in more detail below, this first portion <NUM> of the container drive may cooperate with a second portion of the container drive, which may be located on the drug device.

An exploded view of the needle assembly is shown in <FIG>. In this illustrative embodiment, the needle assembly <NUM> includes a generally cylindrical carrier <NUM> having a relatively flat section <NUM> formed with rails <NUM>, a needle hub <NUM> (which may be wing-shaped as shown), a needle <NUM>, a cam <NUM>, a proximal cover <NUM> and a distal cover <NUM>. The needle <NUM> includes a proximal end <NUM> and a distal end <NUM>. In some embodiments, the needle <NUM> may be fixed to the needle hub <NUM> such that movement of the hub <NUM> causes the needle <NUM> to move as well.

In the illustrative embodiment of <FIG>, the cam <NUM> includes drive helices <NUM> that engages within a notch <NUM> disposed on the hub <NUM> to move the needle hub <NUM> in deployment and/or retraction directions as the cam rotates relative to the carrier <NUM>, as will be explained below. The cam <NUM> includes a driven gear <NUM> having teeth <NUM> that are driven by a drive gear on the drug device. Other suitable drive elements may be employed. Thus, deployment and retraction of the needle are driven by a needle drive mechanism on the drug device, as will be explained below.

In some embodiments, the proximal cover <NUM> is a peelable seal that may be removably affixed to the carrier <NUM>, e.g. via a suitable adhesive. The proximal cover <NUM> may have a pull tab <NUM> that may be easily graspable to facilitate removal. In this regard, the distal position of the pull tab <NUM> may extend beyond the distal end of the needle assembly facilitating ease of grasping and manipulation. However, other types of covers may be used, such as a cap that engages with the carrier, e.g. via threads or other mechanical interlock, or an interference fit.

In some embodiments, the distal cover <NUM> is not configured to be removed, but instead is configured to be pierced through by a needle. In some embodiments, the distal cover may be a thin pierceable layer of material such as a foil seal, and may be affixed to the carrier via adhesive or other suitable arrangement. In other embodiments, however, the distal cover is configured to be removed. Examples of removable distal covers include, for example, a cap that engages with the carrier, e.g. via threads or other mechanical interlock, or an interference fit. Also, like the proximal cover, in one embodiment (not shown) the distal cover may include a peelable seal that includes a graspable portion extending beyond the edges of the needle assembly facilitating ease of grasping and manipulation.

A sequence of steps for assembly of the drug delivery device is shown in <FIG>. First, as seen in <FIG>, the medicament container is inserted distally with the septum end inserted into the drug device <NUM>. Next, as seen in <FIG>, a cap <NUM>, which fits over the distal end of the drug device, is removed. In addition, the proximal cover <NUM> is removed from the carrier <NUM> of the needle assembly <NUM> by peeling the pull tab <NUM> off of the carrier. The rest of the needle assembly <NUM> is housed inside the carrier <NUM>. With the proximal cover <NUM> and the cap <NUM> removed, the carrier <NUM> can be coupled to the drug device <NUM> to couple the needle assembly to the drug device. As shown in <FIG>, the carrier <NUM> may include rails <NUM> that that slide into corresponding slots or grooves in the drug device <NUM> to couple the carrier to the drug device. The rails may fit in a dovetail like manner with the corresponding slots/grooves. <FIG> shows the drug delivery device <NUM> in its final assembled state. It should be appreciated that the order of the above is not important and that any suitable order for assembling the device may be employed.

A sequence of steps for operation of the drug delivery device is shown in <FIG>. <FIG> shows the drug delivery device <NUM> ready to be used. The drug delivery device is first placed against the subject's skin (not shown) such that the distal end of the device is in contact with the intended injection site. Next, the drug delivery device <NUM> is actuated to move the needle to an extended position, as shown in <FIG>. As seen in the enlarged view of FIG. 5B-I, when the needle moves to the extended position, the distal end <NUM> of the needle extends past the distal end of the carrier, which in this embodiment, is the distal cover <NUM>. In this embodiment, the distal end <NUM> of the needle pierces through the distal cover <NUM> when moved to the extended position. With the needle in the extended position, the drug delivery device expels medicament from the medicament container, out through the needle, and into the subject. Next, after medicament delivery is complete, the drug delivery device <NUM> moves the needle from the extended position to a retracted position, as shown in <FIG>. In the retracted position, the distal end <NUM> of the needle may be located inside the carrier <NUM> to prevent inadvertent viewing and/or contact with the needle.

In some embodiments, the needle assembly is removed from the drug device after use, and may be discarded. <FIG> depicts the needle assembly <NUM> being removed from the drug device <NUM> by sliding the carrier <NUM> out of engagement with the drug device <NUM>. Finally, as seen in <FIG>, a cap <NUM> may be placed on the distal end of the drug device, thereby covering distal end of the medicament container and the septum to close off the drug device.

Cross-sections of the drug delivery device as the drug delivery device undergoes a sequence of operational steps are shown in <FIG>.

<FIG> shows the needle assembly <NUM> prior to coupling to the drug device <NUM>. In <FIG>, the medicament container <NUM> has already been inserted into the drug device <NUM>. The septum <NUM> has not yet been pierced by the needle of the needle assembly, and the piston <NUM> is in a proximal position, indicating that the medicament container has not yet expelled medicament. With the medicament container <NUM> coupled to the drug device, the first portion <NUM> of the container drive engages with a second portion <NUM> of the container drive located in the drug device to form a complete container drive. In the illustrative embodiment of <FIG>, the second portion <NUM> of the container drive includes a motor assembly <NUM> that turns a drive shaft <NUM> attached to a drive gear <NUM> that couples to the first portion <NUM> of the container drive, which in turn causes the piston <NUM> to move distally.

In one illustrative embodiment, the first portion <NUM> of the container drive includes a drive ribbon having a retracted configuration defining a spiral and an extended configuration defining a helix. The drive ribbon is movable from the retracted configuration to the extended configuration, where movement to the extended configuration advances the piston <NUM> in a distal direction. A drive member may be disposed radially inside the drive ribbon to engage and rotate the drive ribbon to move the drive ribbon between the retracted and extended configurations. Such a container drive including a drive ribbon is described in <CIT>.

Other container drive mechanisms may be used, as this aspect is not so limited.

In some embodiments, the motor assembly <NUM> drives a drive gear <NUM> that couples to a driven gear <NUM> (see also <FIG>), which in turn is attached to a cam that converts rotational motion to translational motion of the piston <NUM>. Other possible container drive mechanisms include, but are not limited to, a stepper motor, a pneumatic actuator, spring-driven mechanisms, whether linear or rotary, a syringe pump, or a servo motor as the disclosure is not so limited.

As also seen in <FIG>, the drug device includes a needle drive <NUM> that includes a drive gear <NUM>. The drive gear may be driven by a motor or other suitable actuator. In some embodiments, the needle drive may share an actuator with the second portion <NUM> of the container drive, while in other embodiments, the needle drive may have its own actuator, such as a motor.

As seen in <FIG>, in which the needle assembly <NUM> has been coupled to the drug device <NUM>, the drive gear <NUM> is configured to couple to a driven gear <NUM> of the needle assembly <NUM>. In some embodiments, the driven gear <NUM> is coupled to or otherwise integrally formed with of a cam <NUM> of the needle assembly. Detailed views of the cam are shown in <FIG>. As also seen in <FIG>, with the needle assembly <NUM> fully coupled to the drug device, the proximal end <NUM> of the needle has pierced through the septum <NUM> of the medicament container and entered the interior <NUM> of the medicament container.

Turning to <FIG>, with the drug delivery device fully assembled, the drug delivery device <NUM> is brought into contact with the subject's skin <NUM> such that a distal end of the drug delivery device <NUM> is flush against the skin <NUM>. In this illustrative embodiment, the distal cover <NUM> of the needle assembly is flush against the skin <NUM> and as such, the distal cover <NUM> need not be removed.

The drug delivery device <NUM> is then actuated to extend the needle into the skin. As shown in <FIG>, actuation of the drug delivery device <NUM> occurs by pressing actuator button <NUM>. In some embodiments, pressing the actuator button <NUM> may trigger a controller (not shown) to activate a motor (not shown) of the needle drive <NUM> to rotate drive gear <NUM> of the needle drive <NUM>, which causes rotation of the driven gear <NUM>, which in turn causes rotation of the cam <NUM>. As will discussed in greater detail below, rotation of the cam <NUM> may cause distal movement of a needle hub <NUM> that is attached to a needle, causing the needle to move distally to an extended position. As a result, as shown in <FIG>, the needle is moved to an extended position in which the distal end <NUM> of the needle moves out of the carrier <NUM> and is pierced into the subject's skin <NUM>. With the needle pierced into the subject's skin, the drug delivery device may proceed to expel medicament out of the medicament container and through the needle. In this regard, the second portion <NUM> of the container drive is activated to drive the first portion <NUM> of the container drive, causing the piston <NUM> to advance distally. As seen in <FIG>, the piston <NUM> has moved distally to expel medicament out through the needle and into the subject's skin.

Following delivery of medicament to the subject, the needle <NUM> is retracted. As shown in <FIG>, retraction of the needle occurs with a motor or other actuator of the needle drive <NUM> being activated to rotate drive gear <NUM>, which causes rotation of the driven gear <NUM>, which in turn causes rotation of the cam <NUM>. In some embodiments, the rotation directions of the drive gear, driven gear, and/or cam during needle retraction is opposite to the rotation directions of these same components during needle extension. Rotation of the cam <NUM> causes proximal movement of the needle hub <NUM>, causing the needle <NUM> to move proximally to a retracted position. As a result, as shown in <FIG>, the needle is moved to a retracted position in which the distal end <NUM> of the needle is moved back into the carrier <NUM>.

The drug delivery device is then removed from the subject's skin <NUM>, as shown in <FIG>. In some embodiments, with the needle <NUM> in the retracted position inside the carrier, the needle cannot be seen by the subject.

It should be appreciated that aspects described herein are not limited with respect to the needle drive and/or piston drive arrangements as other suitable drive assemblies may be employed.

After use, the needle assembly <NUM> may be removed from the drug device <NUM> and discarded, as shown in <FIG>. As shown in <FIG>, a new needle assembly <NUM> may be attached to the drug device, and the drug delivery device may be closed off by a cap <NUM>. Alternatively, the cap may be installed without also installing a new needle assembly.

<FIG> depicts the sequence of interactions between the drive gear of the drug device and the driven gear of the needle assembly as the drug delivery device undergoes a sequence of operations.

According to one aspect, the needle assemblies are assembled such that its components are in a ready position in which the assembly can be installed to a drug device. In some embodiments, the drive gear and the driven gear may each have a ready position that complement one another to permit the gears to be coupled to one another.

In State <NUM> of <FIG>, the driven gear <NUM> of the needle assembly <NUM> is in its ready position, and the drive gear <NUM> of the drug device is in its ready position. With both gears in the ready position, the relative alignment of the teeth <NUM> of the drive gear <NUM> and the teeth <NUM> of the driven gear <NUM> permit the gears to mesh with one another, which in turn allows the needle assembly <NUM> to be coupled to the drug device <NUM>.

In some embodiments, the drug device controls the drive gear <NUM> to turn to a preset rotational position to set the drive gear in the ready position. Moving the drive gear to a ready position may occur automatically in response to detection of a condition of the drug device. For example, the drug device may detect removal of a used needle assembly and, in response, automatically turn the drive gear to the ready position. In some embodiments, a user may instruct the drug device to move the drive gear to the ready position. For example, the user may interact with a user interface of the drug device, e.g. pushing a "prepare for needle assembly attachment" button, or by simply powering on the device.

In State <NUM> of <FIG>, the drive gear <NUM> is rotated, driving the driven gear <NUM> in the opposite direction. In this illustrative embodiment, the drive gear <NUM> is rotated counter clockwise, causing the driven gear <NUM> to rotate clockwise. In this illustrative embodiment, clockwise rotation of the driven gear <NUM> causes needle extension, as will be discussed in further detail below.

Next, in State <NUM> of <FIG>, to retract the needle, the drive gear <NUM> is rotated in the opposite direction to the direction it moved in State <NUM>. In this illustrative embodiment, the drive gear <NUM> is rotated clockwise, causing the driven gear <NUM> to rotate counter clockwise. In this illustrative embodiment, counter clockwise rotation of the driven gear <NUM> causes needle retraction, as will be discussed in further detail below.

As shown in State <NUM> of <FIG>, the drive gear <NUM> rotates clockwise until the driven gear <NUM> reaches a locked position. The needle assembly <NUM> is then removed from the drug device such that the driven gear <NUM> is disengaged from the drive gear <NUM>. Finally, in State <NUM> of <FIG>, the drive gear, which is no longer in engagement with a driven gear, returns to its ready position. A new needle assembly and driven gear can then be engaged to the drive gear, returning the sequence back to State <NUM>.

In some embodiments, moving the driven gear into a locked position in State <NUM> serves as a feature to prevent re-use of the needle assembly. In the locked position, the driven gear may be rotationally oriented in a manner that prevents engagement of the driven gear to the drive gear.

In some embodiments, as shown in <FIG>, the driven gear <NUM> may include a plurality of evenly spaced teeth <NUM>, along with one or more areas that do not have the same teeth spacing, referred to as blocking portions <NUM>. When the driven gear is in the locked position, the blocking portions <NUM> may be rotationally positioned to physically interfere with teeth <NUM> on the drive gear. As shown in <FIG>, which depicts a used driven gear <NUM> in a locked position and the drive gear <NUM> in a ready position, one or more of the teeth <NUM> of the drive gear <NUM> may collide with the blocking portion <NUM> of the driven gear <NUM>, preventing engagement between the gears. As a result, the needle assembly cannot be coupled to the drug device, thus preventing re-use of the drug assembly.

<FIG> depict the interaction between the cam <NUM>, needle hub <NUM> and carrier <NUM> of a needle assembly <NUM> as a drug delivery device undergoes a sequence of operations for needle extension. In <FIG>, the cam <NUM> is shown in the ready position. The cam includes a protrusion <NUM> that interacts with protrusions and indentations <NUM> on the carrier to form a detent, where rotation of the cam <NUM> is resisted by the protrusions and indentations <NUM> on the carrier until a sufficient amount of force is applied to the cam to rotate the cam protrusion <NUM> past the carrier protrusions <NUM>. In some embodiments, the detent may function similar to a ratchet and pawl arrangement, where the protrusion <NUM> on the cam functions as a pawl and the protrusions and indentations <NUM> on the carrier function as a ratchet.

The needle hub <NUM> is mounted to drive helices <NUM> on the cam. In this regard, the notches <NUM> formed in the wing tips of the needle hub (see also <FIG> and <FIG>). Thus, rotation of the cam in a first direction moves the hub in an extension direction, and rotation of the cam in a second direction opposite to the first direction moves the hub in a retraction direction. This is illustrated in <FIG>.

In <FIG>, the cam <NUM> is being turned in a counter clockwise direction due to turning of the driven gear <NUM> by the drive gear of the drug device. Rotation of the drive helices <NUM> of the cam in the counter clockwise direction causes the helices <NUM> to push the needle hub <NUM> in a distal direction due to the engagement of the helices <NUM> within the notches <NUM>. As a result, shown in <FIG>, the needle <NUM> that is coupled to the hub <NUM> is moved to an extended position. Detailed views of the carrier are shown in <FIG>, detailed views of the cam are shown in <FIG>, and detailed views of the needle hub are shown in <FIG> for ease of reference of the relevant components and structures.

<FIG> depict the interaction between the cam, needle hub and carrier of the needle assembly as the drug delivery device undergoes a sequence of operations for needle retraction. In <FIG>, the cam <NUM> is being turned in a clockwise direction due to turning of the driven gear <NUM> by the drive gear of the drug device. Rotation of the drive helices <NUM> of the cam in the clockwise direction causes the helices <NUM> to pull the needle hub <NUM> in a proximal direction, again due to the engagement of the helices <NUM> within the notches <NUM>. As a result, shown in <FIG>, the needle <NUM> that is coupled to the hub <NUM> is moved to a retracted position. In <FIG>, the cam is shown in a ready position in which the cam can be rotated to extend the needle.

In some embodiments, after medicament delivery, the cam is rotated to a locked position. In some embodiments, moving the cam to a locked position may prevent the needle assembly from being re-used. As shown in <FIG>, the cam is being rotated clockwise beyond the ready position of <FIG>. The protrusion <NUM> of the cam moves past a snap edge <NUM> of the carrier <NUM> and into a lock recess <NUM> of the carrier. When the protrusion <NUM> of the cam is received in the lock recess <NUM>, the cam is locked in place and can no longer rotate in either direction relative to the carrier, thus preventing any further movement of the needle <NUM>.

<FIG> depict various views of the carrier <NUM> of the needle assembly according to one illustrative embodiment. As seen in <FIG> and as discussed above, the carrier may include a cylindrical sidewall <NUM> including a dovetail features <NUM> that serve to couple the carrier to the drug device by sliding into corresponding slots in the drug device. As seen in <FIG> (which is a cross section taken along line 11C-11C of <FIG>, the carrier may include hub guides <NUM> that receive the needle hub. Hub guides <NUM> may be supported by radial support members that interconnect the hub guides to the carrier cylindrical sidewall <NUM>. The guides <NUM> may be sized and shaped to prohibit rotation of the needle hub relative to the carrier and permit only linear sliding of the needle hub relative to the carrier. As seen in <FIG>, the carrier may include surface features that interact with a protrusion on the cam to form a detent, as discussed above. The carrier may include protrusions and indentations <NUM> on an inner wall surface <NUM> of the carrier. The carrier may also include a snap edge <NUM> and a lock recess <NUM>. Turning to the cross-sectional view of the carrier in <FIG>, the carrier may include a cam retention rib <NUM> that engages with a corresponding circumferential trough <NUM> on an outer surface of the cam <NUM> (see <FIG>). The carrier may also have a cam rotational bearing surface <NUM> within which the cam rotates.

<FIG> depict various views of the cam <NUM> according to one illustrative embodiment. As seen in <FIG>, the cam may include a cylindrical body <NUM> with a driven gear <NUM> having a plurality of teeth <NUM> and a blocking portion <NUM> along one axial end of body <NUM>. As seen in <FIG>, the cam may have hub drive helices <NUM> along the opposite axial end of body <NUM> that move the needle hub between extended and retracted positions. As also seen in <FIG>, the cam may include a protrusion <NUM> that interacts with surface features on the carrier to form a detent. As seen in <FIG>, the cam may include a hub lock rib <NUM> that helps restrain movement of the needle hub during piercing of the medicament container septum by the needle and when the cam is in the locked position.

<FIG> depict various views of the needle hub <NUM> according to one illustrative embodiments. As seen in <FIG>, the hub may include a bore <NUM> for receiving a needle. The needle may be fixed to the hub in any suitable manner, for example via an adhesive, insert molding, mechanical interlock, welding, being integrally formed with the needle, UV light activated glue, or any other suitable arrangement.

As seen in <FIG>, the hub may include ribs <NUM>, <NUM> that form a plus-sign shape and are sized to be received within the hub guide <NUM> of the carrier. As discussed above, the needle hub ribs <NUM>, <NUM> complement the shape of the hub guide <NUM> of the carrier to permit the needle hub to slide linearly within the carrier but prohibit rotation of the needle hub relative to the carrier.

As also seen in <FIG>, the needle hub includes arms 47a and 47B, which may be wing-shaped, each with notch <NUM> formed in the outermost edge of the arm. The notches <NUM> have a plurality of contact surfaces that interact with different components of the needle assembly. The needle hub includes a first helical face <NUM> that is pushed distally by the hub drive helix of the cam to move the hub and the needle in an extension direction. The needle hub also includes a second helical face <NUM> that is pulled proximally by the hub drive helix of the cam to move the hub and the needle in a retraction direction. The needle hub may include a forward face <NUM>. During septum piercing and when the cam is in the locked position, the hub lock rib <NUM> of the cam contacts against the forward face <NUM> of the needle hub to help restrain movement of the needle hub.

It should be understood that the drug devices shown are illustrative, as the needle assemblies described herein can be adapted for use with variously configured drug devices, including differently constructed pen-shaped medication injection devices, differently shaped injection devices, and infusion pump devices. The medication may be any of a type that may be delivered by such a drug device. The devices shown are intended to be illustrative and not limiting as the needle assemblies described may be used in other differently configured devices.

To clarify the use of and to hereby provide notice to the public, the phrases "at least one of <A>, <B>,. and <N>" or "at least one of <A>, <B>,. <N>, or combinations thereof" or "<A>, <B>,. and/or <N>" are defined by the Applicant in the broadest sense, superseding any other implied definitions hereinbefore or hereinafter unless expressly asserted by the Applicant to the contrary, to mean one or more elements selected from the group comprising A, B,. In other words, the phrases mean any combination of one or more of the elements A, B,. or N including any one element alone or the one element in combination with one or more of the other elements which may also include, in combination, additional elements not listed.

Claim 1:
A drug delivery device (<NUM>), comprising:
a needle assembly (<NUM>) including a needle carrier (<NUM>), a needle hub (<NUM>) moveable within the needle carrier, and a needle (<NUM>) coupled to the needle hub; and
a drug device (<NUM>) having an actuator and a needle drive gear (<NUM>), the needle carrier (<NUM>) coupleable to the drug device to position a proximal end (<NUM>) of the needle (<NUM>) for insertion through a septum (<NUM>) in fluid communication within a container (<NUM>) of the drug delivery device;
wherein the actuator is configured to activate rotation of the needle drive gear (<NUM>) to move the needle hub (<NUM>) distally from a retracted needle hub position to an extended needle hub position and to move the needle (<NUM>) distally relative to the septum (<NUM>) from a retracted needle position to an extended needle position; and
wherein the needle assembly (<NUM>) is removable from the drug device (<NUM>).