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 having a hub with a distal end and a proximal end; a needle fixed to the hub and having a distal end, for insertion into a patient, and a proximal end; an inner shield disposed proximally of the hub; a spring disposed between the inner shield and the hub and configured to bias the hub distally; an outer shield with a distal end, a proximal end, and a tubular body at least partially encircling a portion of the needle with at least portions located radially outward further from the needle than the inner shield such that the outer shield at least partially encases the hub, the needle, the inner shield, and the spring; and a releasable retaining assembly configured to releasably retain the hub in a first locked state against the biasing of the spring. The distal end of the needle is covered by the outer shield with the hub being in a first locked state. Upon release of the releasable retaining assembly, the hub moves under force of the spring to an unlocked second state. In the unlocked second state, the distal end of the needle extends distally from the distal end of the outer shield.

<CIT> discloses a device for storing and administering a drug. The device includes a housing, a sealing element and a separate low friction plunger which is substantially-permeable to gas over time. The sealing element is typically broken to allow delivery of the drug. The housing may be filled with the drug through an opening other than the opening through which the pusher enters the housing.

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

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 may, in some embodiments, include 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 one aspect, a needle assembly includes a needle handling container that can be used to mount the needle assembly to the device, that is subsequently removed from the needle assembly for operation of the device, and then reused as a tool to remove the needle assembly from the device and contain the used 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.

In another aspect, a needle assembly includes a needle handling container that is integrated into the needle assembly, which can be used to mount the needle assembly to the device, that remains with the needle assembly for operation of the device, and then used as a tool to remove the needle assembly from the device and contain the used 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 above by a patient, caregiver or healthcare professional to deliver medicament to a person.

A schematic of a drug delivery device and a sequence of operations of an illustrative embodiment of a drug delivery device is shown in <FIG>. The drug delivery device includes a needle assembly <NUM> and a drug device <NUM>. In this embodiment, the needle assembly includes a needle carrier <NUM> and a needle <NUM> having a proximal end <NUM> and a distal end <NUM>. The drug device <NUM> includes a medicament container <NUM> and a coupling end <NUM> configured to be received by the needle carrier <NUM> of the needle assembly <NUM>.

In <FIG>, the needle assembly <NUM> is in the process of being coupled to the coupling end <NUM> of the drug device <NUM>. The coupling end <NUM> of the drug device <NUM> is inserted into the needle carrier, resulting in the arrangement shown in <FIG> in which the drug device <NUM> is coupled to the needle carrier <NUM>. As shown in the cross-sectional view of <FIG>, with the drug device <NUM> coupled to the needle carrier <NUM>, the proximal end <NUM> of the needle <NUM> pierces through a septum <NUM> of the medicament container <NUM>. As also shown in the cross-section of <FIG>, the medicament container <NUM> also includes an interior <NUM> and a piston <NUM> that is moveable relative to the interior <NUM> and the septum <NUM>. As appreciated by those skilled in the art, the piston can be moved by various piston-drive device actuators that are conventional in the art.

In the next step in the sequence, shown in <FIG>, the needle <NUM> is moved to an extended position such that a distal end <NUM> of the needle extends beyond a distal end <NUM> of the needle carrier <NUM> by a distance D in order to pierce a subject's skin. As seen in <FIG>, the piston <NUM> is then driven distally to expel medicament out of the interior <NUM> of the medicament container <NUM> through the needle <NUM> and into the subject. In some embodiments, shown in <FIG>, the needle <NUM> may be moveable to a retracted position in which a distal end <NUM> of the needle is moved to a position proximal to a distal end <NUM> of the needle carrier <NUM>. In other embodiments, however, the needle remains in an extended position.

<FIG> depict a series of schematics of a drug delivery device according to one embodiment undergoing a sequence of operational steps.

As shown in <FIG>, the drug delivery device includes a needle assembly <NUM> and a drug device <NUM>. In this illustrative embodiment, the needle assembly <NUM> is initially contained within a container <NUM> having a body <NUM> and a cover <NUM>. The drug device may include a first portion <NUM> and a second portion <NUM>. In some embodiments, the first portion <NUM> includes a coupling end <NUM> that is configured to be coupled with the needle assembly <NUM>. In some embodiments, the first portion <NUM> of the drug device <NUM> may house a medicament container. In some embodiments, the second portion <NUM> of the drug device <NUM> may include a device actuator. In some embodiments, activation of the device actuator serves to expel medicament from the medicament container.

As a first step, the cover <NUM> is removed from the container body <NUM> to expose the needle assembly <NUM> that is located within the container <NUM>. Next, the needle assembly <NUM> is coupled to the drug device <NUM>. In some embodiments, with the needle assembly <NUM> positioned within the container body <NUM>, a user couples the carrier <NUM> of the needle assembly <NUM> to the drug device <NUM> by holding the container body <NUM> and moving the container body toward the coupling end <NUM> of the drug device <NUM> until the needle assembly <NUM> contacts and couples to the drug device <NUM>. As shown in <FIG>, the needle assembly <NUM> may remain within the container body <NUM> during coupling of the needle assembly <NUM> to the coupling end <NUM> of the drug device <NUM>.

Afterwards, as shown in <FIG>, with the carrier <NUM> of the needle assembly coupled to the drug device <NUM>, the container body <NUM> may be removed from the needle assembly <NUM> and the drug device <NUM>.

In the next step, shown in <FIG>, the drug delivery device may be prepared to deliver a dose of medicament by pulling back on an actuator <NUM>. It should be appreciated, however, that the drug delivery device may utilize other types of actuators and delivery mechanisms that do not require the actuator to be pulled back for dose delivery.

Next, as seen in <FIG>, the drug delivery device is placed against a subject's skin <NUM>. In some embodiments, the needle assembly may include a trigger <NUM> that is placed flush against the skin. The trigger structure may also be a shield around the needle <NUM> to visually hide the needle from the subject. In some embodiments, the trigger does not actually trigger the needle extension, but is a biased retractable shield and the trigger of the needle extension is performed by another actuation button or movement by the subject.

As shown in <FIG>, to initiate piercing of the subject's skin, a user may push the drug delivery device down on the user's skin and thus cause the trigger <NUM> to be pushed into the carrier <NUM> of the needle assembly, which may actuate extension of needle <NUM> out of the carrier <NUM> and into the subject's skin <NUM>. Next, as shown in <FIG>, a user may push down on the actuator <NUM> to cause medicament to be expelled from a medicament container within the drug device and out through the needle <NUM> to inject the medicament into the subject.

As shown in <FIG>, after delivery of medicament to the subject, the drug delivery device is removed from the skin <NUM>. As can be appreciated by a review of the sequence of schematics, the trigger <NUM> may remain retracted within the carrier; however, in other embodiments (not shown), the trigger <NUM> may return to its extended position by a biasing action once the device is removed from the subject's skin. A user may then begin the process of removing the needle assembly from the drug device <NUM>. In <FIG>, the user may push the container body <NUM> back onto the needle assembly to couple the needle assembly <NUM> to the container body <NUM>.

As shown in <FIG>, to remove the needle assembly from the drug device, the user may turn the container body <NUM> relative to the drug device to unlock the needle assembly from the coupling end <NUM> of the drug device, and then pull the container body <NUM> away from the drug device to remove the needle assembly from the drug device. As shown in <FIG>, in some embodiments, the needle <NUM> remains in an extended position during removal of the needle assembly from the drug device. In other embodiments, however, the drug delivery device may include an ability to retract the needle prior to removal of the needle assembly.

In some embodiments, a drug delivery device may be packaged as a kit with a drug device and a plurality of needle assemblies each packaged in their own individual containers. As seen in <FIG>, a kit may include a drug device <NUM> having a coupling end <NUM>, an actuator <NUM>, and a needle drive in the form of a drive spring <NUM>. In some embodiments, the spring is a coil spring. In some embodiments, the spring is a torsion spring. In some embodiments, the spring is a leaf spring. In some embodiments, the soring is a bellville washer. In some embodiments, the spring is a wave spring. In some embodiments, the actuator <NUM> may initiate release of medicament from a medicament container housed within the drug device <NUM>. In some embodiments, the drive spring <NUM> may play a role in moving a needle of a needle assembly from a retraction position to an extension position, as will be discussed in more detail below. The plurality of needle assemblies <NUM> may each be contained within individually sealed containers <NUM> having a container body <NUM> and a cover <NUM>. In some embodiments, the cover <NUM> is a peelable seal that may be removably affixed to the container body, e.g. via adhesive. The cover may have a pull tab <NUM> to facilitate removal. However, other types of covers may be used, such as a cap that engages with the container body, e.g. via threads or other mechanical interlock, or an interference fit. It should also be appreciated that a spring need not be employed and instead a motor, a magnet an elastomeric compound or any other device suitable as a carrier drive element that can impart a motion may be employed, as the present disclosure is not limited in this regard.

<FIG> depict a series of needle assembly states as the drug delivery device undergoes a sequence of steps. <FIG> shows the needle assembly <NUM> prior to actuation of the needle <NUM>. The trigger <NUM> is in a protruding position, and the needle <NUM> is in a retracted position. In some embodiments, the needle assembly is arranged as shown in <FIG> when held within a container prior to being coupled to a drug device.

<FIG> shows the needle assembly when the needle <NUM> has been moved to an extended position. As also shown in <FIG>, the trigger <NUM> has been pressed into the carrier <NUM> in a retracted position.

Finally, <FIG> shows the needle assembly moved back into a container body <NUM> for removal of the needle assembly from the drug device.

An exploded view of an illustrative embodiment of a drug delivery device is shown in <FIG>. The drug delivery device includes a needle assembly, including a needle <NUM>, a carrier <NUM>, a trigger <NUM>, and a needle hub <NUM>. The needle assembly is initially housed within a container having a container body <NUM> and a cover <NUM>. The container body <NUM> may include a recess <NUM> formed in the inner wall of the body <NUM> for receiving a fin <NUM> on the carrier <NUM> to enable the needle assembly to couple to the container body <NUM> when housed within the container body <NUM>. Of course it should be appreciated that a fin may be formed in the inner wall of the body <NUM> and a corresponding recess may be formed in the carrier <NUM>, as the present disclosure is not limited in this respect. Detailed views of the carrier are provided at <FIG>. Detailed views of the container body <NUM> are provided at <FIG>.

The drug delivery device also includes a drug device, including a first portion <NUM> and a second portion <NUM>, which is represented schematically in <FIG>. In some embodiments, the first portion <NUM> of the drug device houses a medicament container. In some embodiments, the second portion <NUM> of the drug devices includes an actuator that, when activated, causes medicament to be expelled from the medicament container.

As will be discussed in detail, in some embodiments, the needle assembly couples to the drug device via the carrier <NUM> of the needle assembly physically interlocking with a coupling end <NUM> of the drug device. A drive spring <NUM> may be disposed in the coupling end <NUM>.

<FIG> depict a sequence of steps illustrating coupling of a needle assembly to a drug device, and extension of a needle. Starting with <FIG>, a needle assembly is initially held within a sealed container <NUM>, which includes a container body <NUM> and a cover <NUM>. Next, as shown in <FIG>, the cover <NUM> is removed from the container body <NUM>, exposing the needle assembly such that the needle assembly can be coupled to a coupling end <NUM> of a first portion <NUM> of a drug device. In the illustrative embodiment of <FIG>, the first portion <NUM> of the drug device includes a medicament container <NUM> and a drive spring <NUM> that is also shown in <FIG>.

Next, as shown in <FIG>, with the needle assembly held inside the container body <NUM>, the container body is mounted over the coupling end <NUM> of the first portion <NUM> of the drug device by pushing the container body <NUM> onto the coupling end <NUM>, which is hidden in view by the body <NUM>. During this process, the needle assembly inside the container body <NUM> is coupled to the coupling end <NUM> of the first portion <NUM> of the drug device.

As shown in <FIG>, the container body <NUM> is removed from the needle assembly <NUM>, leaving the needle assembly <NUM> coupled to the first portion <NUM> of the drug device. In this illustrative embodiment, the container body <NUM> may be used as a tool to couple the needle assembly to the drug device by pushing the container body <NUM> straight onto the drug device, as will be discussed further in relation to <FIG>. The container body <NUM> is then removed from the needle assembly <NUM> by pulling the container body <NUM> straight off of the drug device and the needle assembly. In some embodiments, no relative twisting between the container body and the needle assembly and/or the drug device is needed for coupling of the needle assembly to the drug device and/or removal of the container body from the needle assembly. In other embodiments, however, a relative twisting motion may be used.

In <FIG>, with the container body removed, the needle assembly <NUM> can be seen. The needle assembly <NUM> includes a carrier <NUM> and a trigger <NUM> mounted to the end of the carrier <NUM>. The needle assembly <NUM> also includes a needle <NUM>, where at least a portion of the needle is positioned within the carrier <NUM>. At least a portion of the needle may be positioned within a bore <NUM> of the trigger <NUM>. Initially, the needle is in a retracted position in which a distal end <NUM> of the needle does not extend beyond a distal end <NUM> of the trigger <NUM>.

To actuate extension of the needle, a force is exerted upon the trigger <NUM> in a proximal direction, as represented by the arrow shown in <FIG>. This force may be created, for example, by pressing the trigger <NUM> flush against the skin of a subject. Pushing on this trigger actuates the needle <NUM> to move distally to an extended position, shown in <FIG>. In the extended position, the distal end <NUM> of the needle <NUM> has moved out of the bore <NUM> of the trigger, and instead is positioned distal to the distal end <NUM> of the trigger <NUM>.

Finally, <FIG> illustrate removal of the needle assembly from the drug device. As shown in <FIG>, with the needle <NUM> still in the extended position, a user moves the container body <NUM> toward the needle assembly until the needle assembly is received within the container body <NUM>. To unlock the needle assembly from the drug device, a user twists the container body <NUM> in either direction relative to the drug device. Then, to remove the needle assembly from the drug device, the user pulls the container body <NUM> straight off and away from the drug device.

A detailed view of the coupling end of the drug device and the carrier of the needle assembly is shown in <FIG>, with the carrier shown in phantom. The carrier <NUM> includes pawls <NUM> that interact with the coupling end <NUM> of the drug device. When pushing the carrier <NUM> axially onto the coupling end <NUM>, the pawl <NUM> moves into an on-ramp <NUM> of the coupling end <NUM> until the pawl <NUM> snaps over a snap edge <NUM> and into a recess <NUM> to lock the carrier <NUM> onto the drug device. The recess is defined in the sidewall of the device and has a distal boundary defined by the snap edge <NUM>, a proximal boundary defined by the device body, and a pair of circumferential boundaries defined by bumps <NUM>. The wall thickness of the coupling end varies in a manner such that there may be only clearance for pawls <NUM> to enter the on-ramps and thus into a coupling arrangement at certain angular orientations.

If, during initial placement of the carrier onto the drug device, the carrier is not in the correct rotational orientation relative to the drug device, the pawl <NUM> may be guided by the protruding sides <NUM> of the on-ramp <NUM> to rotate the carrier toward an aligned position relative to the drug device. The sides <NUM> are shown in a tapering arrangement. Pawl flanks <NUM> of the pawl <NUM> may slide against the sides <NUM> of the on-ramp <NUM> during mounting of the carrier <NUM> to the coupling end <NUM>. The sides <NUM> may act as a funnel that defines a narrowing width of the on-ramp in a direction toward the snap edge <NUM> and the recess <NUM>.

<FIG> depicts the carrier <NUM> coupled to the drug device. The pawl <NUM> has snapped over the snap edge <NUM> and into the recess <NUM> to rotationally and axially lock the carrier <NUM> to the drug device.

<FIG> depict the carrier in the process of being removed from the first portion of the drug device. As shown in <FIG>, to remove the carrier <NUM> from the first portion <NUM> of the drug device, the parts are twisted relative to one another. The carrier pawls <NUM> first climb up removal bumps <NUM> on the drug device. Sliding of the carrier pawls <NUM> against the removal bumps provides a detent feel. The pawls <NUM> then encounter and enter off-ramps <NUM> of the drug device. Continued relative twisting causes the carrier pawls to slide along the helical sides <NUM> of the off-ramps (<FIG>), resulting in separation of the carrier from the drug device (<FIG>). The radial elevation of the off-ramps <NUM> may be greater than the elevation of the on-ramps
Detailed views of the carrier are provided at <FIG>. Detailed views of the first portion of the drug device and its coupling end are provided at <FIG>.

Operation of the drug delivery device will now be described via a sequence of cross-sectional views. <FIG> depict cross-sectional views of a needle assembly being coupled to a first portion of a drug device. As shown in <FIG>, the needle assembly, which includes a carrier <NUM>, trigger <NUM>, needle hub <NUM> and needle <NUM>, is initially housed within the container body <NUM>. The carrier <NUM> includes fins <NUM> that are received within recesses <NUM> of the container body <NUM>. The carrier also includes axial guide ribs <NUM> with radial tips <NUM> that initially retain the needle hub <NUM> prior to use.

In <FIG>, the carrier <NUM> has been pushed onto the first portion <NUM> of the drug device to engage and align the carrier to the first portion <NUM> of the drug device. At this stage, where the needle carrier <NUM> has not yet fully engaged the drug device, the needle <NUM> has not yet entered the septum <NUM> of the drug device.

As the needle carrier <NUM> is further pushed onto the drug device into a fully engaged position, as shown in <FIG>, the proximal end <NUM> of the needle <NUM> pierces through the septum <NUM> of the drug device. As shown in the enlarged view of <FIG>, the trigger <NUM> includes a rib <NUM> that interacts with legs <NUM> of the hub <NUM>, as will be discussed below. Engagement of the carrier <NUM> to the drug device also axially compresses a drive spring <NUM> located on the drug device against the trigger <NUM>, also referred to as loading the spring. The spring <NUM> remains compressed due to engagement of the carrier <NUM> to the drug device, and due to the needle hub being initially locked to the carrier. As shown in the enlarged view of <FIG>, the legs <NUM> are engaged to ledges <NUM> of the carrier. More specifically, each of the legs <NUM> includes a notch region 41a defined by a radial portion 41b extending outward from an axial leg portion 41c. A catch surface 41d is therefore formed that engages exterior surface 29a of a ledge <NUM>. Accordingly, the exterior surface 29a is sized to fit within the not 41a to facilitate a fixed position prior to deployment. It should be appreciated that in some embodiments, engagement of the carrier <NUM> to the drug device need not load the drive spring <NUM>.

Next, <FIG> shows the trigger <NUM> of the drug delivery device being pushed against skin <NUM> of a subject. As a result, the trigger <NUM> moves in a proximal direction toward the needle carrier <NUM>. As shown in the enlarged view in <FIG>, movement of the trigger in the proximal direction causes a contact surface <NUM> of the trigger rib <NUM> to contact and push against a hub leg <NUM> of the needle hub <NUM>, thus moving the hub leg <NUM> radially inward until the hub leg clears the inner surface of the rib <NUM> and releases from a ledge <NUM> of the carrier <NUM>, thus freeing the needle hub <NUM> to be moveable relative to the carrier <NUM>. With the needle hub <NUM> free to move distally relative to the carrier <NUM>, the spring <NUM>, which had been exerting a force against the needle hub, is free to axially expand and release its stored potential energy, pushing the needle hub <NUM> to move distally relative to the carrier, as shown in <FIG>. The needle <NUM>, which is attached to the needle hub <NUM>, moves distally together with the needle hub into an extension position in which the distal end <NUM> of the needle <NUM> moves through the bore <NUM> of the trigger <NUM> and pierces into the subject's skin <NUM>.

As shown in the enlarged view of <FIG>, in some embodiments, distal movement of the needle hub causes the needle hub legs <NUM> to move toward and into radial recesses <NUM> in the interior of trigger <NUM>, locking the hub <NUM> to the trigger <NUM>. In some embodiments, with the needle hub locked in place, the needle cannot be redeployed.

Detailed views of the needle hub are provided at <FIG>. Detailed views of the trigger are provided at <FIG>.

Finally, <FIG> shows the container body <NUM> being used to remove the needle assembly <NUM> from the drug device. The container body <NUM> may serve as sharps protection to help prevent the needle from being inadvertently contacted.

<FIG> depict various views of the needle carrier <NUM> according to one illustrative embodiment. The fins <NUM> that are received by the recesses of the container body can be seen in the perspective views of <FIG>, as well as in the end views of <FIG>, and the side view of <FIG>. The guide ribs <NUM> can be seen in the cross-sectional view of <FIG>, and the pawls <NUM> can be seen in <FIG>. As shown in this embodiment, the needle carrier <NUM> includes a generally cup-shaped cylindrical carrier body <NUM> defining a cavity <NUM> therein. The carrier body <NUM> includes a head portion <NUM> with a reduced cross-sectional area relative to the body portion <NUM>. The fins <NUM> are shown extending axially along and radially outward from the body portion <NUM>. The pawls <NUM> are formed at the end of pawl arms 22a along the body portion <NUM>. The head portion <NUM> is configured to receive the trigger <NUM> (not shown) which is shaped to fit over the head portion <NUM>. The head portion <NUM> includes axial slots to receive guide ribs. A first of the axial slots <NUM> are configured to receive support ribs <NUM>. A second of the axial slots <NUM> are configured to receive the trigger guide ribs <NUM>. Head portion defines a longitudinal bore <NUM> extending therein. The guide ribs <NUM> may be defined as a continuous surface that defines the bore such the proximal end of the guide ribs <NUM>, with the radial tips <NUM> protruding within cavity <NUM> of the body portion. Bore <NUM> is formed in the end wall <NUM> of the head portion <NUM>.

<FIG> depict various views of the first portion <NUM> of the drug device according to one illustrative embodiment. The coupling end <NUM> can be seen in the perspective view of <FIG> and the side view of <FIG>. The coupling end <NUM> includes an on-ramp <NUM> bounded by protruding sides <NUM>, and off-ramps <NUM> that each have helical sides <NUM>. The coupling end <NUM> also includes a snap edge <NUM> and a recess <NUM>, as well as removal bumps <NUM>.

<FIG> depict various views of the needle hub <NUM> according to one illustrative embodiment. The needle hub <NUM> includes a plurality of legs <NUM> that are able to move in the radially inward and outward direction. The hub also includes slots <NUM> configured to receive the guide ribs <NUM> from the carrier <NUM>. The hub <NUM> also includes a bore <NUM> through which a needle is positioned. 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. Hub <NUM> may have a generally cup-shaped body <NUM> having an axial end wall <NUM> and a cylindrical sidewall <NUM> extend from the end wall. Legs <NUM> are formed along the sidewall. In one embodiment, there are three legs circumferentially spaced apart. Legs <NUM> may be integrally formed in to the sidewall <NUM> and cantilevered attached thereto such that the leg <NUM> can flex. A center axial body <NUM> is shown extending distally from the end wall <NUM> and includes the bore <NUM>. Slots <NUM> are shown having a first portion <NUM> formed in the end wall <NUM> and extending radially outward from the center body <NUM> and a second portion <NUM> extending axially along the sidewall <NUM>.

<FIG> depict various views of the trigger <NUM> according to one illustrative embodiment. The trigger includes ribs <NUM> having a contact surface <NUM> for pushing the needle hub legs radially inward to release the needle hub for needle extension, as described above. As also described above, a recess <NUM> distal to the ribs receives the needle hub leg after needle extension to lock the needle hub in place to prevent subsequent needle deployments. Trigger <NUM> includes a cup-shaped body <NUM> with an axial end wall <NUM> and cylindrical sidewall <NUM> shaped to define a trigger cavity <NUM> to receive the head portion <NUM> of the carrier body <NUM>. Ribs <NUM> are axially disposed along the inner surface of the sidewall and circumferentially spaced apart from one another. Support ribs <NUM> are axially interdisposed between the ribs <NUM> along the inner surface and circumferentially spaced apart from one another. Bore <NUM> is formed in the end wall <NUM>.

<FIG> depict various views of the container body <NUM> according to one illustrative embodiment. The container body includes recesses <NUM> that receive the fins <NUM> of the needle carrier to couple the container body to the needle assembly. The body <NUM> is generally cup-shaped with an axial end wall <NUM> and a sidewall <NUM> extending from the end wall <NUM> to define a container cavity <NUM> sized and shaped to receive the carrier <NUM>. A radial flange <NUM> may extend from the proximal end of the sidewall <NUM> and sized to provide more contact surface for the cover seal. Recesses <NUM> are defined along the inner surface of the sidewall. The end wall <NUM> may be generally hemispherical.

According to one aspect, a drug delivery device may be configured such that the needle of the device remains hidden from a subject throughout all operational steps of the device. For example, the needle may remain hidden during attachment of a needle assembly to a drug device and during removal of the needle assembly from the drug device. The drug delivery device may include a deployment mechanism that moves the needle from a retracted position to an extended position to pierce a subject and permit delivery of medicament to the subject, and a retraction mechanism that retracts the needle after injection of the medicament.

<FIG> depict a series of schematics of a drug delivery device according to one embodiment undergoing a sequence of operational steps. As shown in <FIG>, a drug delivery device may include a needle assembly <NUM> and a drug device <NUM>. The drug device may include a first portion <NUM> that houses a medicament container, and a second portion <NUM> that includes an actuator <NUM> and an actuation arrangement that serves to expel medicament from the medicament container for injection into a subject.

The first portion <NUM> of the drug device may include a coupling end <NUM> for coupling to the needle assembly <NUM>. <FIG> illustrates a process of coupling a needle carrier <NUM> of the needle assembly <NUM> to the drug device. As will be discussed in greater detail below, in some embodiments, to couple the carrier to the drug device, a user pushes the carrier onto the drug device, turns the carrier relative to the drug device, and then again pushes the carrier further onto the drug device.

Next, as shown in <FIG>, the drug delivery device is set for injection by pulling back on the actuator <NUM>. It should be appreciated that many different types of actuation mechanisms may be integrated into the drug delivery device, and what is shown in the provided illustrative embodiments are not intended to limit the drug delivery device.

Next, as shown in <FIG>, the drug delivery device is placed flush with the subject's skin, with the needle carrier <NUM> in contact with the skin <NUM>.

The drug delivery device is now ready to be actuated to inject medicament into the subject. In some embodiments, actuation of the device actuator <NUM>, e.g. by pushing the actuator in a distal direction, may cause multiple actions to occur. First, as shown in <FIG>, pressing down on the actuator <NUM> may cause a needle <NUM> to extend from the needle carrier <NUM> and pierce into the skin <NUM>. Next, the device may permit medicament to be expelled from the medicament container, out through the needle, and into the subject. Finally, as shown in <FIG>, the device may retract the needle back into the needle carrier <NUM>. As a result, with the needle retracted inside the needle carrier, when the drug delivery device is removed from the subject's skin, the needle is no longer external to the device, helping to prevent inadvertent contact with the needle, and allowing a subject to avoid seeing the needle.

Finally, as shown in <FIG>, the needle assembly may be removed from the drug device <NUM> by pulling the needle carrier <NUM> off of the drug device in a distal direction.

An exploded view of an illustrative embodiment of a drug delivery device is shown in <FIG>. The drug delivery device includes a needle assembly, including a needle <NUM>, a carrier <NUM>, a needle hub <NUM>, and a cam <NUM>. In some embodiments, the carrier <NUM> may initially house the other components of the needle assembly. In some embodiments, a proximal cover <NUM> may be positioned on a proximal end of the carrier <NUM>, and a distal cover <NUM> may be positioned on a distal end of the carrier <NUM>. In some embodiments, the proximal cover <NUM> is removable from the needle carrier <NUM> in order to expose the components within the carrier and to permit coupling of the needle carrier to a drug device. In some embodiments, the proximal cover is a peelable seal. 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 other embodiments, however, the distal cover <NUM> is configured to be removed.

The drug device side may include a first portion <NUM> and a second portion <NUM>. The first portion <NUM> may house a medicament container. In some embodiments, the second portion <NUM> may include a device actuator, and may include an actuation mechanism that serves to trigger release of medicament from a medicament container. As shown in <FIG>, the drug device also includes a collar <NUM>, a drive spring <NUM>, a retraction trigger <NUM>, and an extension trigger <NUM>. In some embodiments, the drive spring <NUM> is a torsion spring.

As will be discussed in detail, in some embodiments, the needle assembly couples to the drug device via the carrier <NUM> physically interlocking with a coupling end <NUM> of the drug device.

<FIG> depict the drug delivery device of <FIG> undergoing a sequence of steps including coupling of a needle assembly to a drug device, extension of a needle, and retraction of the needle. Starting with <FIG>, components of a needle assembly are initially held within the needle carrier <NUM>, which is sealed via a proximal cover <NUM> and a distal cover <NUM>. Next, as shown in <FIG>, the proximal cover <NUM> is removed from the carrier <NUM>, exposing the other components of the needle assembly and preparing the carrier <NUM> to be coupled to a coupling end <NUM> of a first portion <NUM> of a drug device. In the illustrative embodiment of <FIG>, the first portion <NUM> of the drug device includes a collar <NUM> at the coupling end <NUM> of the drug device.

In some embodiments, the collar <NUM> is rotatable between a deactivated orientation in which the needle carrier cannot be coupled to the collar, and an activated orientation in which the needle carrier can be coupled to the collar. <FIG> shows the collar in the deactivated state. In this state, the needle carrier <NUM> is physically blocked from sliding onto the collar.

In <FIG>, the collar <NUM> has been rotated to an activated orientation. The needle carrier can now be slid onto the collar <NUM>. A user first pushes the carrier <NUM> onto the collar, then rotates the carrier relative to the collar, and finally pushes the carrier further onto the collar, resulting in the needle assembly being coupled to the drug device as shown in <FIG> and <FIG>. The needle carrier may be retained to the drug device via a detent, which will be discussed in further detail below.

Next, as shown in <FIG>, a user actuates the drug device and causes the extension trigger <NUM> to activate, which causes needle <NUM> to move from a retracted position to an extended position, piercing through distal cover <NUM> in the process. It should be appreciated that in this embodiment, both the extension and retraction triggers are provided; however the present disclosure is not limited in this regard. Thus, in one embodiment, only the extension trigger is provided. In another embodiment, only the retraction trigger is provided.

Following this, a retraction trigger <NUM> is activated, which causes the needle <NUM> to move back to a retracted position within the carrier <NUM>.

In some embodiments, a user may be able to remove the needle assembly from the drug device. As shown in <FIG>, the needle carrier <NUM> may be pulled straight off of the drug device to remove the needle assembly. In some embodiments, the needle assembly is configured to prevent re-attachment of the used needle assembly back to the drug device, as will be described in further detail below.

A series of cross-sectional views of the drug delivery device of <FIG> as the device undergoes a sequence of operational steps is provided at <FIG>.

<FIG> shows the drug delivery device in a state in which the needle assembly is not yet coupled to the drug device. The needle assembly includes a needle carrier <NUM>, as well as a needle <NUM>, needle hub <NUM> and cam <NUM> housed within the needle carrier <NUM>. A distal cover <NUM> is also located at a distal end of the needle carrier <NUM>. On the drug device side, the drug device includes a collar <NUM> and a torsion spring <NUM>.

In <FIG>, the collar <NUM> is shown in a deactivated state. In the deactivated state, the collar is in a rotational orientation relative to the needle carrier that prevents the needle carrier from sliding onto the collar. As seen in <FIG>, in the deactivated state, collar arms <NUM> are aligned with tabs <NUM> of the needle carrier. The presence of the collar arms <NUM> physically interfere with the tabs <NUM> of the needle carrier, thus preventing the needle carrier from being moved onto the collar.

As shown in <FIG>, the collar can be rotated to an activated state relative to the needle carrier. In the activated state, slots <NUM> on the collar are now rotationally aligned with the carrier tabs <NUM>, thus giving the carrier clearance to be pushed onto the collar.

The spring <NUM> is initially held in a wound state. In other words, prior to actuation of the drug delivery device, the spring <NUM> has stored spring potential energy. With the collar in the position shown in <FIG>, the spring <NUM> is held in its wound state by the presence of extension trigger <NUM>. As shown in the enlarged view of <FIG>, the extension trigger <NUM> physically blocks the collar <NUM> from rotating, which in turn prevents the spring <NUM> from being able to unwind.

<FIG> shows the needle carrier <NUM> pushed onto the collar <NUM>, with the carrier tabs <NUM> received within the slots of the collar. At this initial engagement stage, the needle <NUM> has not yet entered the septum <NUM> of the medicament container <NUM>.

After this initial engagement with the drug device, the needle carrier is turned relative to the drug device and then further pushed onto the drug device, resulting in full engagement of the needle carrier with the drug device, shown in <FIG>. At the full engagement stage, the proximal end <NUM> of the needle <NUM> has penetrated through the septum <NUM> and entered the interior of the medicament container <NUM>. As shown in the enlarged view of <FIG>, at full engagement, the carrier <NUM> and the first portion <NUM> of the drug device are in an area of contact <NUM>. As the user pushes the needle carrier against an injection site, axial forces between the needle carrier and the drug device are transferred in the area of contact <NUM>. Detailed views of the carrier are shown in <FIG> and detailed views of the collar are shown in <FIG>.

Next, in preparation for injection of medicament into a subject, the drug delivery device is held against the skin <NUM> of the subject, with the distal cover <NUM> at the end of the needle carrier being held in contact against the skin.

The user actuates the drug delivery device to pull back on the extension trigger <NUM>, moving the trigger in the proximal direction, which frees the collar <NUM> to rotate due to unwinding of the torsion spring <NUM>. Rotation of the collar rotates the cam <NUM>, which, because the radial ends <NUM> of the arms <NUM> ride on the cam surfaces <NUM>, causes the needle hub <NUM> to extend the needle <NUM>, moving the needle from a retracted position to an extended position in which the distal end <NUM> of the needle <NUM> penetrates through the distal cover <NUM> and into the subject's skin <NUM>, as shown in <FIG>.

At the needle extension stage shown in <FIG>, the torsion spring <NUM> is still partially wound. The spring <NUM> is prevented from further unwinding due to the presence of the retraction trigger <NUM>. As shown in the enlarged view of <FIG>, the retraction trigger <NUM> physically blocks rotation of the collar <NUM>, which in turn prohibits further unwinding of the spring.

Next, the retraction trigger <NUM> is released, pulling the retraction trigger in a proximal direction away from the collar <NUM>, freeing the collar to rotate due to unwinding of the spring <NUM>. This further rotation of the collar drives the cam <NUM> and needle hub <NUM> to retract the needle. Releasing the retraction trigger may be accomplished by any suitable arrangement. For example, pulling the device away from the user's skin could cause the retraction trigger to release. Completing the injection along with needle withdrawal and a short time delay could cause the retraction trigger to release. In one embodiment, the retraction trigger is actuated automatically after completion of injection. For a complete dose, and to avoid excessive "drooling" after the needle is withdrawn, a suitable delay after the injection is completed may be desired. Such a delay could be ~<NUM> seconds before needle is retracted. Such a delay may be automatic or may be an instruction to the user to hold the device against the skin and then the release trigger is moved when the device is removed from the user's skin.

In some embodiments, the needle assembly may be removed from the drug device after injection of medicament. As shown in <FIG>, the needle carrier <NUM> is removed from the collar <NUM> by pulling the carrier off of the collar in a distal direction. The tabs <NUM> of the carrier slide out of the slots <NUM> of the collar, and the arms <NUM> flex radially inwardly to permit removal of the carrier from the collar. The carrier is shown fully removed from the drug device in <FIG>. Here, the needle carrier <NUM> is a multi-function component in that the carrier may be used to mount the needle assembly to the device, may remain with the needle assembly for operation of the device, may be used as a tool to remove the needle assembly from the device, and contains the used needle assembly after use.

<FIG> depict the rotational positions of the collar relative to the drug device of the embodiment of <FIG> as the drug delivery device undergoes a sequence of operational steps. For ease of visualizing components, the collar is shown in phantom.

First, <FIG> show two perspective views of the collar prior to use, when the collar is in the deactivated state. The collar is rotationally mounted to a housing <NUM> of the first portion of the drug device. The collar includes first and second collar stops <NUM> and <NUM> that are initially in contact against the housing <NUM>. As seen in <FIG>, the first collar stop <NUM> is initially in contact with first housing stop <NUM>. As seen in <FIG>, the second collar stop <NUM> is initially in contact with second housing stop <NUM>. Detailed views of the collar are shown in <FIG>, and detailed views of the housing are shown in <FIG>.

<FIG> show two perspective views of the collar after it has been rotated and placed in the activated state. In this state, the first collar stop <NUM> is in contact with the extension trigger <NUM>, and the second collar stop <NUM> is in the air. Contact between the first collar stop <NUM> and the extension trigger <NUM> prevents the collar from further rotating and prevents the spring <NUM> from unwinding.

Next, when the extension trigger <NUM> is released and pulled back in a proximal direction, the collar is permitted to rotate due to unwinding of the spring <NUM> until the second collar stop <NUM> contacts the retraction trigger <NUM>, as shown in <FIG>. The first collar stop <NUM> is in the air, as shown in <FIG>.

Next, when the retraction trigger <NUM> is released and pulled back in a proximal direction, the collar is permitted to further rotate due to unwinding of the spring <NUM> until the first and second collar stops contact the housing <NUM> of the first portion of the drug device, as shown in <FIG>.

<FIG> depict the arrangements of the cam and needle hub of the needle assembly as the drug delivery device undergoes a sequence of needle extension steps. For ease of visualizing components, the carrier is shown in phantom. <FIG> shows the cam <NUM> in the initial angular position prior to use of the drug delivery device. The cam may include tabs <NUM> that are initially aligned with the carrier tabs <NUM> to permit coupling of the carrier <NUM> with the collar of the drug device. The cam may include detents <NUM> that are received by an inner wall surface <NUM> of the carrier <NUM> to help maintain the position of the cam within the carrier prior to use. The cam may include teeth <NUM> that abut against arms <NUM> of the needle hub <NUM> to retain the hub in place during piercing of the septum with the proximal end of the needle. The cam may include extension cam surfaces <NUM> (also referred to as extension helices <NUM>) on which rides the radial ends <NUM> of the arms <NUM>. The cam may also include retraction cam surfaces (also referred to as retraction helices <NUM>) defined by radially inwardly extending lips 1053a that also interacts with a radial end <NUM> of an arm <NUM> during rotation of the cam. Specifically, a first surface <NUM> (see <FIG>) of the radial end <NUM> rides along the extension cam surface <NUM> when the cam is being rotated in one direction and a second surface <NUM> (see <FIG>) of the radial end <NUM> rides along the retraction cam surface <NUM> when the cam is being rotated in the opposite direction. Detailed views of the hub are shown in <FIG> and detailed views of the cam are shown in <FIG>.

<FIG> shows the state of the cam an intermediate angular position when the extension trigger has been released and the collar rotates, causing the cam to rotate (shown in the counter clockwise direction) as well. Rotation of the cam causes the extension helices <NUM> of the cam to push against the arms <NUM> of the hub, driving the hub <NUM> in the distal direction to move the needle <NUM> into an extended position, shown in <FIG>, where the cam is at the final angular position for needle extension. In the extended state, the hub <NUM> is held between the cam's extension helices <NUM> and retraction helices <NUM>.

<FIG> depict the arrangements of the needle carrier as the drug delivery device undergoes a sequence of needle retraction steps. <FIG> shows the state of the cam when the retraction trigger has been released and the collar rotates, causing the cam to rotate as well (still in the counter clockwise direction). Rotation of the cam causes the retraction helices <NUM> to pull against the arms <NUM> of the hub <NUM> in the proximal direction, thus moving the needle <NUM> into a retracted position, shown in <FIG>. The internal radial lip 1053a is formed along the retraction helices <NUM> that catches the end of the arms of the needle hub during retraction.

In this retracted state, the detents <NUM> on the cam engage with the carrier wall, preventing the cam from rotating. In addition, in some embodiments, the cam tabs <NUM> are misaligned with the carrier tabs <NUM>, which prohibits the carrier from being mounted onto the collar of the drug device. Such an arrangement may help to prevent re-use of the needle.

<FIG> depict various views of the needle carrier <NUM> according to one illustrative embodiment. The needle carrier <NUM> includes a cylindrical body <NUM>. The tabs <NUM> are formed on the inner wall of the body adjacent to an end and extend along a portion of the axial length of the body <NUM> and extend radially inwardly. A central bore region <NUM> extends along the central axis and acts to guide the hub, specifically the central axle <NUM> of the hub <NUM> (see <FIG>). Radially inwardly extending struts <NUM> attach the hub guide to the inner wall of the body. A bearing surface <NUM> on each strut supports the central bore <NUM> of the cam <NUM>. Retention snaps hold the cam to the carrier <NUM>. Cam rotation detents <NUM> (start of cam rotation) and cam rotation snaps <NUM> (end of cam rotation) limit the extent of rotational displacement of the cam.

<FIG> depict various views of the cam <NUM> according to one illustrative embodiment. The cam <NUM> includes a generally cylindrical body <NUM> on which the extension cam surfaces <NUM> and retraction cam surfaces <NUM> are formed. Also formed on the body is are the tabs <NUM>. The body further includes a bearing wall <NUM> through which extends the central bore <NUM>. As discussed above, the cam may include teeth <NUM> (which in this embodiment extends axially on the cylindrical body in the same direction as the cam surfaces), detents <NUM> (which are provided on the outer cylindrical body at an apex of the retraction cam surface), extension helices <NUM> and retraction helices <NUM>.

<FIG> depict various views of the needle hub <NUM> according to one illustrative embodiment. The hub may include arms <NUM> that interact with the cam of the needle assembly during extension and retraction of a needle. As described above, the hub includes a central axle <NUM>. The axle1058 may also include a bore <NUM> through which the needle extends. The radially extending arms <NUM> is sized to fit within the space <NUM> formed in the central bore region <NUM> of the needle carrier <NUM>. Each arm <NUM> includes a radial end <NUM> having first surface <NUM> and second surface <NUM>. The first surface is configured to ride along the extension cam surface <NUM> when the cam is being rotated in one direction and the second surface <NUM> is configured to ride along the retraction cam surface <NUM> when the cam is being rotated in the opposite direction. A forward face <NUM> is configured to aid in allowing the needle to pierce the septum. In this respect, face <NUM> acts as a bearing surface to transmit the force applied to the carrier as the carrier is being inserted onto the first portion <NUM> of the drug device.

<FIG> depict various views of the collar <NUM> according to one illustrative embodiment. As seen in the figures, the collar has a generally cylindrical body <NUM> formed with arms <NUM> and slots <NUM>. The arms include an abutment surface <NUM> that precludes the insertion of the needle carrier <NUM> along the slot <NUM> defined by the arm <NUM>. The arms also include a ramp <NUM> that causes the arm to flex radially inward (due to the gap <NUM> between the arms and the body) to permit removal of the needle carrier. The slots <NUM> may be configured to receive tabs of the needle carrier upon insertion, as discussed above. The collar may include a first collar stop <NUM> and a second collar stop <NUM> that interact with the housing of the drug device and with the retraction and extension triggers that demark the end of travel. The collar may further include a split rib <NUM> that engages a collar retention groove <NUM> to holds the collar onto the first portion <NUM>. A notch <NUM> may be formed along the inner surface to anchor an end of the torsion spring.

<FIG> depict various views of the housing <NUM> of the first portion <NUM> of the drug device according to one illustrative embodiment. As discussed above, the housing <NUM> may include a first housing stop <NUM> and a second housing stop <NUM> that interact with the collar during operation of the device. As seen in <FIG>, the housing may include a retraction trigger slot <NUM> through which a retraction trigger can move, as well as an extension trigger slot <NUM> through which an extension trigger can move. The housing may also include alignment slots <NUM> configured to receive tabs of the needle carrier during coupling of the needle carrier to the housing. A trigger slot <NUM> may be formed on an inner wall of the housing. The distal end of the housing includes the collar retention groove <NUM>.

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, comprising:
a needle assembly (<NUM>) including a needle carrier (<NUM>), a needle hub (<NUM>) moveable relative to the needle carrier, and a needle (<NUM>) coupled to the needle hub;
a drug device (<NUM>) having a container with a septum (<NUM>) disposed at a container end opening and a carrier drive element (<NUM>), the needle carrier (<NUM>) removably coupleable to the drug device; and
a deployment trigger (<NUM>) configured to activate the carrier drive element (<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 distally relative to the septum from a retracted needle position to an extended needle position.