Patent Description:
Various types of automatic injection devices have been developed to allow drug solutions and other liquid therapeutic preparations to be administered by untrained personnel or to be self-injected. Generally, these devices include a reservoir that is pre-filled with the liquid therapeutic preparation, and some type of automatic needle-injection mechanism that can be triggered by the user. Many of these devices, such as auto-injectors, are designed so that the reservoir, such as a pre-filled syringe, is assembled into the device during assembly of the device. In addition to automatically deploying the needle-injection mechanism, many drug delivery devices also automatically shield the needle after use of the device to prevent any unintended contact with the needle. Documents <CIT>, <CIT> and <CIT> describe automatic injection devices.

In one aspect, a drug delivery device includes a housing, a syringe assembly including a barrel, a stopper, and a cannula, with at least a portion of the syringe assembly positioned within the housing, a drive assembly configured to move the stopper within the barrel upon actuation of the drive assembly, with at least a portion of the drive assembly positioned within the housing, a needle cover having a pre-use position where the cannula is positioned within the needle cover, an actuation position where the needle cover is configured to actuate the drive assembly, and a post-use position where the cannula is positioned within the needle cover, and a cap receiving a portion of the needle cover, with the cap configured to prevent movement of the needle cover from the pre-use position to the actuation position.

The cap may be engaged with the housing. The cap may include a protrusion received by a cap opening defined by the needle cover. The protrusion of the cap may be configured to engage the needle cover upon movement of the needle cover from the pre-use position to the actuation position. The protrusion of the cap may be moveable via an extension arm of the cap, and where engagement between the extension arm and the housing prevents radially outward movement of the protrusion. The protrusion may be configured to be removed from the cap opening of the needle cover upon axial movement of the cap. The protrusion may be configured to engage the needle cover and deflect radially outward upon axial movement of the cap. The protrusion may define a first cam surface and the needle cover may define a second cam surface, with the first cam surface configured to engage the second cam surface to deflect the protrusion radially outward.

The housing may include a lower housing shell and an upper housing shell. The housing may also further include a cassette body received by the lower housing shell.

The cap may include an outer portion, with the protrusion extending from the outer portion. The cap may further include a retainer and the syringe assembly may further include a rigid needle shield, with at least a portion of the retainer positioned within the outer portion of the cap and the retainer configured to remove the rigid needle shield upon removal of the outer portion from the housing.

The device further includes a lever actuation member moveable between a locked position where actuation of the drive assembly is prevented and a released position where actuation of the drive assembly is allowed, with the needle cover engaging the lever actuation member and moving the lever actuation member to the released position when the needle cover is in the actuation position. The needle cover may prevent movement of the lever actuation member from the locked position to the released position when the needle cover is in the pre-use position. The lever actuation member is rotatable about a rotation axis between the locked position and the released position. The lever actuation member may include a restriction surface configured to engage the needle cover and restrict rotation of the lever actuation member when the needle cover is in the pre-use position. The restriction surface of the lever actuation member may be spaced from the needle cover to form a gap when the needle cover is in the pre-use position.

The device may include one or several of the following features, taken individually or according to all technical possible combinations:.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary aspects of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner.

The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art.

Referring to <FIG> a drug delivery device <NUM> according to one aspect of the present invention includes a first subassembly <NUM>, a second subassembly <NUM>, and a syringe assembly <NUM>. The first subassembly <NUM> includes a cap <NUM> having an outer portion <NUM>, a needle cover <NUM>, a syringe holder <NUM>, a cassette body <NUM>, and a lower housing shell <NUM>. The second subassembly <NUM> includes a drive assembly <NUM>, a motor body <NUM>, a lever actuation member <NUM>, and an upper housing shell <NUM>. The syringe assembly <NUM> is received by the syringe holder <NUM> and includes a barrel <NUM>, a stopper <NUM>, a cannula <NUM>, and a rigid needle shield (RNS) <NUM>. Although an RNS is utilized, other suitable needle shield arrangements may be utilized. The lower housing shell <NUM>, the cassette body <NUM>, and the upper housing shell <NUM> generally form a housing for receiving the various components of the device <NUM>, although other suitable housing arrangements may be utilized. As discussed in more detail below, the first subassembly <NUM> and the second subassembly <NUM> are secured to each other during assembly by a locking clip <NUM>, although other suitable arrangements may be utilized. The drug delivery device <NUM> may be an auto-injector, although the features described herein may be incorporated into other suitable drug delivery devices.

The drug delivery device <NUM> is configured to automatically deliver a dose of medicament from the syringe assembly <NUM> to a patient upon actuation of the device <NUM>. More specifically, upon actuation of the drug delivery device <NUM>, the drive assembly <NUM> is configured to engage the stopper <NUM> of the syringe assembly <NUM>, displace the syringe assembly <NUM> such that the cannula <NUM> pierces the skin of the patient, and displace the stopper <NUM> within the barrel <NUM> of the syringe assembly <NUM> to deliver the medicament within the barrel <NUM>. The drug delivery device <NUM> includes a storage position (<FIG> and <FIG>), a pre-use position (<FIG> and <FIG>), an actuation position (<FIG>), an injection position (<FIG>), and a post-use position (<FIG>). As discussed in more detail below, the needle cover <NUM> is configured to shield the cannula <NUM> of the syringe assembly <NUM> from the patient when the device <NUM> is in the pre-use and the post-use positions. In particular, the needle cover <NUM> is moveable between a pre-use position, an actuation position, and a post-use positon, with a spring <NUM> biasing the needle cover <NUM> towards the pre-use position and the post-use position. The spring <NUM> is positioned between the needle cover <NUM> and the syringe holder <NUM>, although other suitable arrangements may be utilized. The lever actuation member <NUM> is moveable between a locked position where movement of the drive assembly <NUM> is prevented and a released position where movement of the drive assembly <NUM> is allowed. More specifically, the lever actuation member <NUM> is rotatable about a rotation axis <NUM> between the locked position and the released position. When the lever actuation member <NUM> is in the locked position, the lever actuation member <NUM> is engaged with the motor body <NUM> and the drive assembly <NUM> to prevent movement of the drive assembly <NUM>. When the lever actuation member <NUM> is in the released position, the lever actuation member <NUM> is disengaged from the motor body <NUM> thereby allowing movement of the drive assembly <NUM> toward the syringe assembly <NUM>. The rotation axis <NUM> of the lever actuation member <NUM> extends perpendicular to a longitudinal axis of the device <NUM>, although other suitable arrangements may be utilized.

Referring again to <FIG>, the drive assembly <NUM> includes a plunger body <NUM> having a plunger rod portion <NUM> and a drive member <NUM>. The drive member <NUM> is a compression spring received within a drive opening <NUM> defined by the plunger body <NUM>, although other suitable drive members may be utilized, including, but not limited to, compressed gas, an electric motor, hydraulic pressure, other types of springs, etc. The drive member <NUM> engages the plunger body <NUM> and the motor body <NUM> and biases the plunger body <NUM> in a direction extending from the second subassembly <NUM> toward the first subassembly <NUM>. The plunger body <NUM> defines a lever opening <NUM> that receives the lever actuation member <NUM> and defines the rotation axis <NUM> of the lever actuation member <NUM>. The lever actuation member <NUM> prevents movement of the plunger body <NUM> when the lever actuation member <NUM> is in the locked position through engagement of the lever actuation member <NUM> with the motor body <NUM>. Upon rotation of the lever actuation member <NUM> from the locked position to the released position, the lever actuation member <NUM> is disengaged from the motor body <NUM> thereby allowing the drive member <NUM> to move the plunger body <NUM> and the plunger rod portion <NUM> toward the first subassembly <NUM>. The plunger rod portion <NUM> and the drive member <NUM> are spaced from and parallel to each other and extend in a longitudinal direction of the device <NUM>.

The drive assembly <NUM> further includes a spring guide member <NUM> secured to the upper housing shell <NUM> and received within the drive opening <NUM> of the plunger body <NUM>. The drive member <NUM> is received by the spring guide member <NUM> such that the drive member <NUM> is positioned between the plunger body <NUM> and the spring guide member <NUM>. The drive assembly <NUM> also includes a plunger rod cover <NUM> that receives the plunger rod portion <NUM> of the plunger body <NUM>. The plunger rod cover <NUM> is configured to guide insertion of the plunger rod portion <NUM> into the barrel <NUM> of the syringe assembly <NUM> and engage the stopper <NUM> of the syringe assembly <NUM> to dispense the medicament from the barrel <NUM> of the syringe assembly <NUM>. The plunger rod cover <NUM> and the plunger rod portion <NUM> may be formed integrally or formed as separate components.

The plunger body <NUM> of the drive assembly <NUM> also includes an audio indicator member <NUM> configured to provide an audible indication to a user when the device <NUM> transitions to the post-use position. As discussed in more detail below, the audio indicator member <NUM> is configured to engage one or more ribs <NUM> of the cassette body <NUM> when the device <NUM> is in the injection position thereby deflecting the audio indicator member <NUM>. When the drug delivery device <NUM> transitions from the injection position to the post-use position, the audio indicator member <NUM> disengages from the rib(s) <NUM> of the cassette body <NUM> and contacts the lower housing shell <NUM> to provide an audible click, although the audio indicator member <NUM> could also contact other suitable portions of the device <NUM> to provide the audible indicator.

Referring to <FIG>, in the storage position, the cap <NUM> is secured to the lower housing shell <NUM> and engaged with the needle cover <NUM>. Movement of the needle cover <NUM> from the pre-use position to the actuation position causes engagement between the needle cover <NUM> and the lever actuation member <NUM> thereby actuating the drive assembly <NUM>. After removal of the cap <NUM> by grasping the outer portion <NUM>, the needle cover <NUM> may be moved from the pre-use position to the actuation position by pressing the needle cover <NUM> against a skin surface of a patient and axially pressing the device <NUM> against the skin surface. As detailed below, the engagement between the cap <NUM> and the needle cover <NUM> prevents the needle cover <NUM> from moving into engagement with the lever actuation member <NUM>. Accordingly, removal of the cap <NUM> from the device <NUM> allows for the actuation of the device <NUM>. As discussed in more detail below, removal of the cap <NUM> from the device <NUM>, as shown in <FIG> and <FIG>, also removes the RNS <NUM> from the syringe barrel <NUM> thereby exposing the cannula <NUM>, which is still received within the needle cover <NUM> in the pre-use position of the device <NUM>.

Referring to <FIG>, in the actuation position, the cap <NUM> is removed and the needle cover <NUM> is positioned in the actuation position by engaging a skin surface of a patient, which moves the needle cover <NUM> further within the device <NUM> toward the second subassembly <NUM>. When the needle cover <NUM> has moved a sufficient distance within the device <NUM>, a portion of the needle cover <NUM> engages the lever actuation member <NUM>, which rotates the lever actuation member <NUM> about the rotation axis <NUM> from the locked position to the released position.

Referring to <FIG>, in the injection position, the lever actuation member <NUM> is in the released position, which allows the plunger body <NUM> of the drive assembly <NUM> to move toward the first subassembly <NUM> such that the plunger body <NUM> or the plunger rod cover <NUM> engages the stopper of the syringe assembly <NUM>. Initial engagement of the drive assembly <NUM> with the syringe assembly <NUM> moves the syringe assembly <NUM> and the syringe holder <NUM> within the device <NUM> and relative to the cassette body <NUM> until the syringe holder <NUM> abuts a stop <NUM> defined by the cassette body <NUM>. During this initial movement of the syringe assembly <NUM> and syringe holder <NUM> with the needle cover <NUM> pressed against a skin surface of a patient, the cannula <NUM> of the syringe assembly <NUM> extends beyond the needle cover <NUM> and pierces the skin surface of the patient. Further movement of the plunger body <NUM>, which is driven by the drive member <NUM>, moves the stopper <NUM> relative to the barrel <NUM> of the syringe assembly <NUM> to dispense medicament from the barrel <NUM> of the syringe assembly <NUM>, through the cannula <NUM>, and into the patient. The plunger body <NUM> will continue moving until the stopper <NUM> bottoms out on the barrel <NUM> of the syringe assembly <NUM>. When the stopper <NUM> bottoms out or just before the stopper <NUM> bottoms out, the audio indicator member <NUM> will disengage from the rib(s) <NUM> of the cassette body <NUM> and contact the lower housing shell <NUM> at approximately the same time to provide the audible indication to the patient that the dose of medicament has been delivered. In addition to the audible indication, the drug delivery device <NUM> provides one or more visual indicators to notify a patient of the status of the device <NUM>. In particular, the cassette body <NUM> may be formed from transparent material to allow visual confirmation of movement of the stopper <NUM> and/or another visual indicator provided by the drive assembly <NUM>, syringe holder <NUM>, and/or syringe assembly <NUM>. The lower housing shell <NUM> also defines an indicator opening <NUM>, which provides visual indication that the plunger body <NUM> is in a final position and the dose of medicament has been delivered. The visual indicators may utilize contrasting colors, symbols, patterns, or any other suitable visual indicia to indicate the various statuses of the device.

Referring to <FIG>, <FIG>, and <FIG>, in the post-use position, the needle cover <NUM> extends to the post-use position to shield the cannula <NUM> when the needle cover <NUM> is removed from a skin surface of a patient. As shown more clearly in <FIG>, the cassette body <NUM> includes at least one lock arm <NUM> and the needle cover <NUM> includes at least one lock protrusion <NUM>, although other suitable configurations may be utilized. The lock arm <NUM> of the cassette body <NUM> engages the lock protrusion <NUM> of the needle cover <NUM> to prevent any further use of the device <NUM> and exposing of the cannula <NUM> of the syringe assembly <NUM>. During the transition of the device <NUM> from the injection position to the post-use position, the lock arm <NUM> of the cassette body <NUM> deflects to allow the lock protrusion <NUM> of the needle cover <NUM> to pass by the cassette body <NUM> with the lock arm <NUM> returning to its original position to prevent movement of the needle cover <NUM> back toward the pre-use and actuation positions. In the pre-use position of the needle cover <NUM>, a portion of the needle cover <NUM> engages a cover stop <NUM> of the syringe holder <NUM> to limit axial movement of the needle cover <NUM> in a direction extending from the second subassembly <NUM> toward the first subassembly <NUM>. After use of the device <NUM>, the syringe holder <NUM> is displaced within the cassette body <NUM> relative to the needle cover <NUM>, which allows the needle cover <NUM> to extend to the post-use position when a patient removes the needle cover <NUM> from a skin surface. As shown in <FIG>, the needle cover <NUM> will move to the post-use position when the needle cover <NUM> is removed from a skin surface of a patient regardless of a position of the stopper <NUM> within the barrel <NUM> of the syringe assembly <NUM>. Accordingly, if a patient removes the needle cover <NUM> from a skin surface after only a portion of the dose of medicament has been delivered, the needle cover <NUM> will still move to the post-use position and will prevent further use of the device <NUM>.

Referring to <FIG>, and <FIG>, as discussed above, engagement between the cap <NUM> and the needle cover <NUM> prevents the needle cover <NUM> from moving into engagement with the lever actuation member <NUM>. The cannula <NUM> is positioned within the needle cover <NUM> when the needle cover <NUM> is in the pre-use position and the post-use position. The needle cover <NUM> is configured to actuate the drive assembly <NUM> when the needle cover <NUM> is in the actuation position. Removal of the cap <NUM> from the device <NUM> allows for the actuation of the device <NUM>. More precisely, in one aspect of the present application, the outer portion <NUM> of the cap <NUM> includes a body <NUM> defining an interior space <NUM> that receives a portion of the needle cover <NUM> when the device <NUM> is in the storage position with the outer portion <NUM> secured to the lower housing shell <NUM>. The outer portion <NUM> of the cap <NUM> is secured to the lower housing shell <NUM> via a lock protrusion <NUM> that is received by a lock recess <NUM> defined by the body <NUM> of the outer portion <NUM> of the cap <NUM>. The outer portion <NUM> also includes a grip surface <NUM> to facilitate the grasping and removal of the outer portion <NUM> of the cap <NUM> from the lower housing shell <NUM>.

The outer portion <NUM> includes a pair of protrusions <NUM> received by cap openings <NUM> defined by the needle cover <NUM>, although one or more protrusions <NUM> and one or more cap openings <NUM> may be utilized. The protrusions <NUM> of the outer portion <NUM> are configured to engage the needle cover <NUM> upon movement of the needle cover <NUM> from the pre-use position to the actuation position. For instance, with the device <NUM> in the storage position with the outer portion <NUM> secured to the lower housing shell <NUM>, if the device <NUM> is dropped or impacted to apply a force to the needle cover <NUM>, the lever actuation member <NUM>, and/or other component, the protrusions <NUM> of the outer portion <NUM> restrict movement of the needle cover <NUM>, which prevents any unintended actuation of the device <NUM>. The protrusions <NUM> of the outer portion <NUM> are moveable in a radial direction via extension arms <NUM> of the outer portion <NUM> of the cap <NUM>. As shown in <FIG>, for example, engagement between the extension arms <NUM> and the lower housing shell <NUM> prevents radially outward movement of the protrusions <NUM>. More precisely, the lower housing shell <NUM> includes a skirt configured to surround the extension arms <NUM> of the outer portion <NUM> when the outer portion <NUM> is mounted on the lower housing shell <NUM>, which prevents radially outward movement of the protrusions <NUM> as long as the outer portion <NUM> is mounted on the lower housing shell <NUM>. The protrusions <NUM> are configured to be removed from the cap opening <NUM> of the needle cover <NUM> upon axial movement of the outer portion <NUM>. In particular, the protrusions <NUM> are configured to engage the needle cover <NUM> and deflect radially outward upon axial movement of the outer portion <NUM> of the cap <NUM>.

Referring to <FIG>, the protrusions <NUM> each define a first cam surface <NUM> and the needle cover <NUM> defines a second cam surface <NUM>, with the first cam surface <NUM> configured to engage the second cam surface <NUM> to deflect each protrusion <NUM> radially outward, which allows separation of the outer portion <NUM> from the needle cover <NUM>. The first and second cam surfaces <NUM>,<NUM> are complementary, inclined surfaces, although other suitable arrangements may be utilized.

Referring to <FIG>, the needle cover <NUM> prevents movement or rotation of the lever actuation member <NUM> from the locked position to the released position when the needle cover <NUM> is in the pre-use position. The lever actuation member <NUM> includes a body <NUM> having a restriction surface <NUM> configured to engage the needle cover <NUM> and restrict rotation of the lever actuation member <NUM> when the needle cover <NUM> is in the pre-use position. When the device <NUM> is in the storage position, if the device <NUM> is dropped or impacted to apply a force to the lever actuation member <NUM>, the lever actuation member <NUM> is prevented from fully rotating to allow actuation of the drive assembly <NUM> due to the engagement between the restriction surface <NUM> of the lever actuation member <NUM> and the needle cover <NUM>. The restriction surface <NUM> is spaced from the needle cover <NUM> to form a gap <NUM> when the device <NUM> is in the storage and pre-use positions to prevent any increase in friction in the movement of the needle cover <NUM> while still preventing unintended actuation of the device <NUM>.

The body <NUM> of the lever actuation member also includes an assembly surface <NUM> configured to engage a locking pin (not shown) received by a pin opening <NUM> defined by the motor body <NUM>. Prior to assembly, the second subassembly <NUM> may include a locking pin that extends through the pin opening <NUM>, which prevents rotation of the lever actuation member <NUM> and unintentional actuation of the drive assembly <NUM> during assembly of the device <NUM>. The body <NUM> of the lever actuation member also includes a needle cover contact surface <NUM>, a motor body contact surface <NUM>, and defines a recessed area <NUM>. The needle cover contact surface <NUM> of the lever actuation member <NUM> engages a lever contact portion <NUM> of the needle cover <NUM> when the needle cover <NUM> is moved to the actuation position thereby rotating the lever actuation member <NUM> from the locked position to the released position. The motor body contact surface <NUM> of the lever actuation member <NUM> engages a stop surface <NUM> of the motor body <NUM> when the lever actuation member <NUM> is in the locked position, which prevents movement of the plunger body <NUM>. When the lever actuation member <NUM> rotates from the locked position to the released position, the motor body contact surface <NUM> disengages from the stop surface <NUM> of the motor body <NUM>, which allows the drive member <NUM> to move the plunger body <NUM>.

The recessed area <NUM> of the lever actuation member <NUM> provides clearance for the lever contact portion <NUM> of the needle cover <NUM> to allow for rotation of the lever actuation member <NUM> from the locked position to the released position. The position of the restriction surface <NUM> of the lever actuation member <NUM> overlaps in an axial direction of the device <NUM> with the position of the lever contact portion <NUM> of the needle cover <NUM> when the needle cover <NUM> is in the pre-use position and until the needle cover <NUM> has fully moved to the actuation position, which prevents unintentional actuation of the device <NUM> as discussed above. When the needle cover <NUM> is fully moved to the actuation position, the lever contact portion <NUM> of the needle cover <NUM> no longer overlaps with the position of the restriction surface <NUM> of the lever actuation member and, instead, overlaps with the position of the recessed area <NUM> in a direction extending in an axial direction of the device <NUM> and engages the needle cover contact surface <NUM> to rotate the lever actuation member <NUM> as described above. The restriction surface <NUM> of the lever actuation member <NUM> is planar and is configured to engage a corresponding planar surface on the bottom of the needle cover contact surface <NUM> when the needle cover <NUM> is in the pre-use position, although other suitable configurations may be utilized.

Referring to <FIG>, according to one aspect of the present application, the cap <NUM> further includes a retainer <NUM> having a body <NUM> with a removal projection <NUM> configured to remove the RNS <NUM> upon axial movement of the outer portion <NUM> of the cap <NUM> away from the lower housing shell <NUM>. A portion of the retainer <NUM> is received within the interior space <NUM> of the outer portion <NUM>. The outer portion <NUM> includes a retaining tab <NUM> received by a retainer opening <NUM> defined by the body <NUM> of the retainer <NUM> to secure the retainer <NUM> to the outer portion <NUM>. As detailed below, the retaining tab <NUM> is configured to engage the retainer <NUM> upon axial movement of the outer portion <NUM> away from the lower housing shell <NUM>. As shown more clearly in <FIG>, the retainer <NUM> further includes a pair of wings <NUM> extending radially outward from the body <NUM> of the retainer <NUM>, with each wing <NUM> configured to engage a rib <NUM> extending radially inward from the body <NUM> of the outer portion <NUM>. The wings <NUM> prevent wobbling between the outer portion <NUM> and the retainer <NUM> once the outer portion <NUM>, the retainer <NUM>, and the RNS <NUM> has been removed.

As shown in <FIG>, the retaining tab <NUM> of the outer portion <NUM> is disengaged from the retainer <NUM> when the outer portion <NUM> is secured to the lower housing shell <NUM> with the device <NUM> in the storage position. As shown in <FIG>, <FIG>, and <FIG>, the retaining tab <NUM> of the outer portion <NUM> is disengaged from the retainer <NUM> when the outer portion <NUM> is secured to the lower housing shell <NUM>. The retaining tab <NUM> of the outer portion <NUM> is secured to the body <NUM> of the outer portion <NUM> via an extension arm <NUM>. The retaining tab <NUM> is moveable radially inward via the extension arm <NUM>. The flexibility of the extension arm <NUM> facilitates the assembly of the retainer <NUM> to the outer portion <NUM> by allowing the retaining tab <NUM> to deflect radially inward as the retaining tab <NUM> engages the retainer <NUM> until the retaining tab <NUM> is received within the retainer opening <NUM>. The retainer <NUM> includes a flange <NUM>, which is engaged with the outer portion <NUM> when the outer portion <NUM> is secured to the lower housing shell <NUM>. The flange <NUM> of the retainer <NUM> is spaced from the outer portion <NUM> upon axial movement of the outer portion <NUM> away from the lower housing shell <NUM>.

As shown in <FIG>, the body <NUM> of the retainer <NUM> is cylindrical and includes a first end <NUM> and a second end <NUM> positioned opposite the first end <NUM>. The removal projection <NUM> extends radially inward from body <NUM> of the retainer <NUM> via a removal arm <NUM>. The removal arm <NUM> extends radially inward and in a direction extending from the second end <NUM> of the body <NUM> to the first end <NUM> the body <NUM>, which allows the retainer <NUM> to be positioned over the RNS <NUM> and syringe assembly <NUM> during assembly of the outer portion <NUM> and the retainer <NUM> onto the device <NUM>. The removal projection <NUM> is moveable relative to the body <NUM> of the retainer <NUM> via the removal arm <NUM>. More specifically, the removal projection <NUM> is moveable radially outward during assembly of the retainer <NUM> to the RNS <NUM> and moveable radially inward during removal of the outer portion <NUM> and the retainer <NUM>. The removal projection <NUM> includes a surface <NUM> that is configured to engage a complementary surface <NUM> of the RNS <NUM>. The surface <NUM> of the removal projection <NUM> of the retainer <NUM> is disengaged from the corresponding surface <NUM> of the RNS <NUM> when the outer portion <NUM> is secured to the lower housing shell <NUM>. The surface <NUM> of the removal projection <NUM> is planar, although other suitable shapes and configurations may be utilized. The corresponding surface <NUM> of the RNS <NUM> is planar, although other suitable shapes and configurations may be utilized. The corresponding surface <NUM> of the RNS <NUM> is defined by a flange portion of the RNS <NUM>.

Referring to <FIG>, the syringe holder <NUM> is disengaged with the plunger body <NUM> of the drive assembly <NUM> when the outer portion <NUM> is secured to the lower housing shell <NUM>. Referring to <FIG>, for example, the syringe holder <NUM> is engaged with the plunger body <NUM> of the drive assembly <NUM> upon axial movement of the outer portion <NUM> of the cap <NUM> away from the lower housing shell <NUM>. More specifically, a pair of arms extend from the syringe holder <NUM> and engage the audio indicator member <NUM> of the plunger body <NUM>, although other suitable configurations may be utilized. The engagement between syringe holder <NUM> and the plunger body <NUM> of the drive assembly <NUM> prevents the removal of the outer portion <NUM> and the RNS <NUM> from moving the syringe holder <NUM> relative to the cassette body <NUM> due to the friction between the syringe assembly <NUM> and the syringe holder <NUM>. The engagement between the syringe holder <NUM> and the plunger body <NUM> also restricts the axial movement of the syringe holder <NUM> within the device <NUM> caused by movement of the device <NUM> or by gravity when the device is in the pre-use position.

Referring to <FIG>, when the device <NUM> is in the storage position with the outer portion <NUM> secured to the lower shell assembly <NUM>, the flange <NUM> of the retainer <NUM> abuts the outer portion <NUM> (<FIG>), the retaining tab <NUM> of the outer portion <NUM> is positioned within the retainer opening <NUM> and spaced from the proximal portion of the body <NUM> of the retainer <NUM> (<FIG>), the protrusion <NUM> of the outer portion <NUM> is received within the cap opening <NUM> of the needle cover <NUM> and spaced from the needle cover <NUM> (<FIG>), the surface <NUM> of the removal projection <NUM> is spaced from the corresponding surface <NUM> of the RNS <NUM> (<FIG>), and the syringe holder <NUM> is spaced from the plunger body <NUM> of the drive assembly <NUM> (<FIG>). In the storage position of the device <NUM>, the retainer <NUM> is engaged with the syringe holder <NUM>. When the flange <NUM> of the retainer <NUM> abuts the outer portion <NUM>, the planar surface <NUM> of the removal projection <NUM> of the retainer <NUM> is properly positioned relative to the complementary surface <NUM> of the RNS <NUM>. In other words, abutment of the flange <NUM> with the outer portion <NUM> ensures the retainer <NUM> is sufficiently positioned axially towards the lower housing shell <NUM> to allow removal of the RNS <NUM> as described below.

Referring to <FIG>, as the outer portion <NUM> is initial axially moved away from the lower housing shell <NUM> (<FIG>) with the lock protrusion <NUM> only partially received within the lock recess <NUM>, the flange <NUM> of the retainer <NUM> is spaced from the outer portion <NUM> and the retaining tab <NUM> is still spaced from the body <NUM> of the retainer <NUM> (<FIG>), the protrusion <NUM> of the outer portion <NUM> is engaged with the needle cover <NUM> (<FIG>), the surface <NUM> of the removal projection <NUM> is spaced from the corresponding surface <NUM> of the RNS <NUM> (<FIG>), and the syringe holder <NUM> is spaced from the plunger body <NUM> of the drive assembly <NUM> (<FIG>).

Referring to <FIG>, as the outer portion <NUM> continues to be axially moved away from the lower housing shell <NUM> (<FIG>) with the lock protrusion <NUM> only partially received within the lock recess <NUM>, the flange <NUM> of the retainer <NUM> is spaced from the outer portion <NUM> and the retaining tab <NUM> is still spaced from the body <NUM> of the retainer <NUM> (<FIG>), the protrusion <NUM> of the outer portion <NUM> is engaged with the needle cover <NUM> (<FIG>), the surface <NUM> of the removal projection <NUM> is spaced from the corresponding surface <NUM> of the RNS <NUM> (<FIG>), and the syringe holder <NUM> is engaged with the plunger body <NUM> of the drive assembly <NUM> (<FIG>).

Referring to <FIG>, as the outer portion <NUM> continues to be axially moved away from the lower housing shell <NUM> (<FIG>) with the lock protrusion <NUM> separated from the lock recess <NUM>, the flange <NUM> of the retainer <NUM> is further spaced from the outer portion <NUM> and the retaining tab <NUM> is engaged with the body <NUM> of the retainer <NUM> (<FIG>) such that the outer portion <NUM> and the retainer <NUM> move together axially away from the lower housing shell <NUM>, the protrusion <NUM> of the outer portion <NUM> disengages with the needle cover <NUM> (<FIG>) and is removed from the cap opening <NUM>, the surface <NUM> of the removal projection <NUM> is spaced from the corresponding surface <NUM> of the RNS <NUM> (<FIG>), and the syringe holder <NUM> is engaged with the plunger body <NUM> of the drive assembly <NUM> (<FIG>).

Referring to <FIG>, as the outer portion <NUM> continues to be axially moved away from the lower housing shell <NUM> (<FIG>), the flange <NUM> of the retainer <NUM> is spaced from the outer portion <NUM> and the retaining tab <NUM> is engaged with the body <NUM> of the retainer <NUM> (<FIG>) such that the outer portion <NUM> and the retainer <NUM> move together axially away from the lower housing shell <NUM>, the protrusion <NUM> of the outer portion <NUM> continues to be disengaged from the needle cover <NUM> (<FIG>), the surface <NUM> of the removal projection <NUM> engages the corresponding surface <NUM> of the RNS <NUM> (<FIG>), and the syringe holder <NUM> is engaged with the plunger body <NUM> of the drive assembly <NUM> (<FIG>).

Referring to <FIG>, as the outer portion <NUM> continues to be axially moved away from and separated from the lower housing shell <NUM> (<FIG>), the flange <NUM> of the retainer <NUM> is spaced from the outer portion <NUM> and the retaining tab <NUM> is engaged with the body <NUM> of the retainer <NUM> (<FIG>) such that the outer portion <NUM> and the retainer <NUM> move together axially away from the lower housing shell <NUM>, the protrusion <NUM> of the outer portion <NUM> continues to be disengaged from the needle cover <NUM> (<FIG>), the surface <NUM> of the removal projection <NUM> continues to be engaged with the corresponding surface <NUM> of the RNS <NUM> and axially displaces the RNS <NUM> relative to the barrel <NUM> of the syringe assembly <NUM> (<FIG>), and the syringe holder <NUM> is engaged with the plunger body <NUM> of the drive assembly <NUM> (<FIG>).

Referring to <FIG>, upon complete removal of the outer portion <NUM> from the lower housing shell <NUM>, the RNS <NUM> continues to remain engaged with the retainer <NUM> with the RNS <NUM> entirely separated from the barrel <NUM> of the syringe assembly <NUM>.

Referring again to <FIG>, as discussed above, the outer portion <NUM> and the retainer <NUM> of the cap <NUM> are configured to minimize the amount of force required to remove the outer portion <NUM> and retainer <NUM> from the device <NUM> by separating the various components from each other sequentially, rather than at the same time. By sequencing the removal of the outer portion <NUM> from the lower housing shell <NUM>, the separation of the protrusion <NUM> of the outer portion <NUM> from the needle cover <NUM>, and the removal of the RNS <NUM> from the syringe assembly <NUM>, a patient is only required to apply sufficient force for each step in the sequence rather than a larger force that would be required to remove such components at the same time. As discussed above, such sequencing is provided via the relative movement between the outer portion <NUM> and the retainer <NUM>, relative movement between the outer portion <NUM> and the needle cover <NUM>, and the relative movement between the retainer <NUM> and the RNS <NUM>.

Referring to <FIG>, a drug delivery device <NUM> according to a further aspect of the present invention is shown. The drug delivery device <NUM> is similar to the drug delivery device <NUM> shown in <FIG>, with certain differences discussed below in detail. The drug delivery device <NUM> includes, among other components, a motor body <NUM>, a plunger body <NUM>, a plunger rod portion <NUM>, a lever actuation member <NUM>, a syringe holder <NUM>, a needle cover <NUM>, a cassette body <NUM>, a cap <NUM>, a retainer <NUM>, an upper housing shell <NUM>, and a lower housing shell <NUM>.

Referring to <FIG>, the motor body <NUM> is similar and functions similarly to the motor body <NUM> of <FIG>, but further includes a longitudinal groove <NUM>, reinforcing rib(s) <NUM>, and cassette clip(s) <NUM>. The longitudinal groove <NUM> is configured to receive a molding split line of the plunger body <NUM> to ensure smooth sliding between the motor body <NUM> and the plunger body <NUM>. The reinforcing rib(s) <NUM> provide additional support for the pair of arms <NUM> of the motor body <NUM>. The cassette clip(s) <NUM> is received by an opening(s) <NUM> defined by the cassette body <NUM> to secure the motor body <NUM> to the cassette body <NUM>, which is discussed in more detail below. The cassette clip(s) <NUM> include an angled face <NUM> and a planar face <NUM>, which is configured to allow insertion of the cassette clip(s) <NUM> into the opening(s) <NUM> of the cassette body <NUM>, but prevent the easy removal of the cassette clip(s) <NUM> once inserted into the opening(s) <NUM> of the cassette body <NUM>. A bottom surface <NUM> of the motor body <NUM> includes chamfered portions <NUM> to aid assembly of the device <NUM>.

Referring to <FIG> and <FIG>, the plunger body <NUM> is formed separately from the plunger rod portion <NUM> rather than being formed integrally. Further, the device <NUM> does not include the plunger rod cover <NUM>. The plunger body <NUM> defines an opening <NUM> that receives a plunger rod clip <NUM> of the plunger rod portion <NUM>. The plunger rod clip <NUM> is barb-shaped and configured to be inserted into the opening <NUM> of the plunger body <NUM>, but not easily removed from the opening <NUM>, although other suitable shapes and configurations may be utilized. The plunger rod clip <NUM> defines a central opening <NUM>, which allows the plunger rod clip <NUM> to compress as the plunger rod clip <NUM> is inserted into the opening <NUM> of the plunger body <NUM> and expand to its original shape once received within the plunger body <NUM>. The plunger rod portion <NUM> includes a plunger body stop(s) <NUM> and a biasing member <NUM>. The plunger body stop(s) <NUM>, which may be one or more projections, contact the plunger body <NUM> when the plunger rod clip <NUM> is inserted into the opening <NUM> of the plunger body <NUM>. The biasing member <NUM> engages the plunger body <NUM> during insertion of the plunger rod clip <NUM> into the opening <NUM> of the plunger body <NUM> and biases the plunger rod portion <NUM> toward the plunger body <NUM>. The biasing member <NUM> provides additional leeway for insertion of the plunger rod clip <NUM> into the opening <NUM> of the plunger body <NUM> while ensuring there is no gap between the plunger body <NUM> and the plunger rod portion <NUM> after assembly. The biasing member <NUM> of the plunger rod portion <NUM> is annular, although other suitable shapes and configurations may be utilized.

The plunger rod portion <NUM> further includes a stopper interface <NUM> that is received by the stopper <NUM>. The stopper interface <NUM> is a cruciform projection, although other suitable shapes and configurations may be utilized. The plunger rod portion <NUM> has a conical external shape configured to reduce stress on the syringe assembly <NUM>, although other suitable shapes may be utilized. The plunger body <NUM> includes a lever rib <NUM> extending into the lever opening <NUM> of the plunger body <NUM>. The lever rib <NUM> is configured to be received by the lever actuation member <NUM>, as discussed in more detail below.

Referring to <FIG>, the lever actuation member <NUM> is similar to and functions similarly to the lever actuation member <NUM> described above and shown in <FIG>. The lever actuation member <NUM>, however, defines a groove <NUM> at the rotation axis <NUM> that receives the lever rib <NUM> of the plunger body <NUM>. The engagement between the groove <NUM> and the lever rib <NUM> prevents relative lateral movement between the plunger body <NUM> and the lever actuation member <NUM>. The needle cover contact surface <NUM> of the lever actuation member <NUM> includes a larger surface compared to the needle cover contact surface <NUM> of the lever actuation member <NUM> of <FIG>.

Referring to <FIG>, the syringe holder <NUM> is similar to and functions similarly to the syringe holder <NUM> of <FIG>. The syringe holder <NUM>, however, further includes a plurality of ribs <NUM> extending circumferentially around the syringe holder <NUM>. The plurality of ribs engage the spring <NUM>. The securing ring <NUM> of the syringe holder <NUM> further includes a plurality of projections <NUM> that extend radially inward. The plurality of projections <NUM> engage the syringe assembly <NUM> to remove any gap between the outer surface of the syringe assembly <NUM> and the syringe holder <NUM>. The plurality of projections <NUM> are elastomeric and may compress when the syringe assembly <NUM> is received within the syringe holder <NUM>.

Referring to <FIG>, the needle cover <NUM> is similar to and functions similarly to the needle cover <NUM> of <FIG>. The needle cover <NUM> includes a spring rib <NUM> which engages the spring <NUM> to hold the spring <NUM> between the needle cover <NUM> and the syringe holder <NUM>. The needle cover <NUM> also includes a cassette rib(s) <NUM> to guide movement of the needle cover <NUM> relative to the cassette body <NUM>.

Referring to <FIG>, <FIG>, the cassette body <NUM> is similar to and functions similarly to the cassette body <NUM> of <FIG>. As discussed above, the cassette body <NUM> includes the opening(s) <NUM> that receive the cassette clip(s) <NUM> of the motor body <NUM>. The cassette body <NUM> includes a needle cover clip(s) <NUM> that engage clip surface(s) <NUM> of the needle cover <NUM>. The clip surface(s) <NUM> of the needle cover <NUM> are planar, although other suitable shapes and configurations may be utilized. The needle cover clip(s) <NUM> are configured to restrict the axial movement of the needle cover <NUM> relative to the cassette body <NUM>. The cassette body <NUM> further includes motor body rib(s) <NUM> and upper housing shell rib(s) <NUM>, which are configured to engage corresponding portions of the motor body <NUM> and the upper housing shell <NUM> to aid in the assembly of the device <NUM>. The cassette body <NUM> also includes syringe holder stop(s) <NUM>, which are configured to engage portions of the syringe holder <NUM> to limit the axial movement of the syringe holder <NUM> relative to the cassette body <NUM>. Although not shown in <FIG>, the locking clip <NUM> may also be utilized with the drug delivery device <NUM>.

Referring to <FIG>, the cap <NUM> is similar to and functions similarly to the cap <NUM> described above and shown in <FIG>. The cap <NUM> includes a protrusion(s) <NUM> that is received by a cap opening(s) <NUM> defined by the needle cover <NUM>, which is positioned <NUM> degrees relative to the position of those elements of the cap <NUM> of <FIG>. The protrusion(s) <NUM> of the cap <NUM> is configured to engage the needle cover <NUM> upon movement of the needle cover <NUM> from the pre-use position to the actuation position. For instance, with the device <NUM> in the storage position with the cap <NUM> secured to the lower housing shell <NUM>, if the device is dropped or impacted to apply a force to the needle cover <NUM>, the lever actuation member <NUM>, and/or other component, the protrusion(s) <NUM> restricts movement of the needle cover <NUM>, which prevents any unintended actuation of the device <NUM>. The cap <NUM> further includes a retainer clip(s) <NUM> and a rib(s) <NUM> for engaging a wing(s) <NUM> of the retainer <NUM>. The retainer clip(s) <NUM> and the rib(s) <NUM> secure the retainer <NUM> to the cap <NUM> and prevent any movement or wobbling of the retainer <NUM> relative to the cap <NUM>. The retainer <NUM> is configured to remove the RNS <NUM> when the cap <NUM> is removed from the lower housing shell <NUM>. The cap <NUM> includes a lower housing shell clip(s) <NUM> for engaging the lower housing shell <NUM> to secure the cap <NUM> to the lower housing shell <NUM>. The upper housing shell <NUM> and the lower housing shell <NUM> are similar and function similarly to the upper housing shell <NUM> and the lower housing shell <NUM> discussed above and shown in <FIG>. The lower housing shell <NUM>, however, has a cap interface <NUM> to receive the lower housing shell clip(s) <NUM> of the cap <NUM>.

Referring to <FIG>, the drug delivery device <NUM> is shown in an injection position. The injection depth of the cannula <NUM> is determined by contact between the syringe holder <NUM> and the cassette body <NUM> at point X and contact between the needle cover <NUM> and the syringe holder <NUM> at point Y.

Referring to <FIG>, the drug delivery device <NUM> includes an audio indicator member <NUM>, which is similar to and functions similarly to the audio indicator member <NUM> described above and shown in <FIG>. In the same manner as the audio indicator member <NUM>, which is described above, the audio indicator member <NUM> of the drug delivery device <NUM> is configured to provide an audible indication to a user when the device <NUM> transition to the post-use position. The audio indicator member <NUM> is configured to engage rib(s) <NUM> of the cassette body <NUM> when the device <NUM> is in the injection position thereby deflecting the audio indicator member <NUM>. The audio indicator member <NUM> disengages from the rib(s) <NUM> of the cassette body <NUM> and contacts the lower housing shell <NUM> to provide an audible click when the drug delivery device <NUM> transition from the injection position to the post-use position. However, a distal end <NUM> of the rib(s) <NUM> of the cassette body <NUM> is angled rearward toward the upper housing shell <NUM>, which beneficially provides a louder audible click compared to the arranged of the rib(s) <NUM> of the cassette body <NUM> discussed above in connection with <FIG>.

In one aspect or embodiment, an angle Z of the distal end <NUM> of the rib(s) <NUM> of the cassette body <NUM> relative to a plane extending perpendicularly to a longitudinal axis of the device <NUM> is greater than <NUM> degrees. In one aspect or embodiment, the angle Z of the distal end <NUM> of the rib(s) <NUM> is greater than <NUM> degrees. In one aspect or embodiment, the angle Z of the distal end <NUM> is <NUM> degrees.

Claim 1:
A drug delivery device (<NUM>) comprising:
a housing (<NUM>, <NUM>, <NUM>);
a syringe assembly (<NUM>) comprising a barrel (<NUM>), a stopper (<NUM>), and a cannula (<NUM>), at least a portion of the syringe assembly (<NUM>) positioned within the housing (<NUM>, <NUM><NUM>);
a drive assembly (<NUM>) configured to move the stopper (<NUM>) within the barrel (<NUM>) upon actuation of the drive assembly (<NUM>), at least a portion of the drive assembly (<NUM>) positioned within the housing (<NUM>, <NUM>, <NUM>);
a needle cover (<NUM>) having a pre-use position where the cannula (<NUM>) is positioned within the needle cover (<NUM>), an actuation position where the needle cover (<NUM>) is configured to actuate the drive assembly (<NUM>), and a post-use position where the cannula (<NUM>) is positioned within the needle cover (<NUM>);
a cap (<NUM>) receiving a portion of the needle cover (<NUM>), the cap (<NUM>) comprising a protrusion (<NUM>) received by a cap opening (<NUM>) defined by the needle cover (<NUM>) and configured to prevent movement of the needle cover (<NUM>) from the pre-use position to the actuation position; and
a lever actuation member (<NUM>) moveable between a locked position where actuation of the drive assembly (<NUM>) is prevented and a released position where actuation of the drive assembly (<NUM>) is allowed, the needle cover (<NUM>) engaging the lever actuation member (<NUM>) and moving the lever actuation member (<NUM>) to the released position when the needle cover (<NUM>) is moved in the actuation position,
characterized in that the lever actuation member (<NUM>) is rotatable about a rotation axis (<NUM>) between the locked position and the released position, the rotation axis (<NUM>) extending perpendicular to the longitudinal axis of the drug delivery device (<NUM>).