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 comprising 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 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, and a needle cover having a pre-use position where the cannula is positioned within the needle cover, an actuation position where the drive assembly is actuated, and a post-use position where the cannula is positioned within the needle cover. The needle cover configured to engage the lever actuation member and move the lever actuation member to the released position when the needle cover is in the actuation position.

The device may further include a syringe holder moveable relative to the housing between a first position and a second position, the syringe assembly received by the syringe holder. The syringe holder is configured to move from the first position to the second position when the needle cover is in the actuation position, with a portion of the cannula of the syringe assembly extending outside of the needle cover when the syringe holder is in the second position and when the needle cover is in the actuation position. A portion of the needle cover may engage a cover stop of the syringe holder to restrict axial movement of the needle cover in at least one direction when the needle cover is in the pre-use position. The drive assembly may include a plunger body having a plunger rod portion and a drive member, with the drive member configured to move the plunger body within the housing. A longitudinal axis of the plunger rod may be spaced from and parallel to a longitudinal axis of the drive member. The drive member may be a compression spring. The drive assembly may further include a plunger rod cover positioned over at least a portion of the plunger rod portion, with the plunger rod cover configured to engage the stopper of the syringe assembly. The drive assembly may further include a spring guide member, with the drive member positioned over the spring guide member.

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 may be 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 needle cover may include a lever contact portion and the lever actuation member may include a needle cover contact surface, with the lever contact portion of the needle cover configured to engage the needle cover contact surface of the lever actuation member and rotate the lever actuation member about the rotation axis from the locked position to the released position when the needle cover is in the actuation position. The lever actuation member may define a recessed area configured to receive a portion of the lever contact portion of the needle cover when the needle cover is in the actuation position. The lever contact portion of the needle cover may define a cylindrical surface and the needle cover contact surface of the lever actuation member may define a planar surface.

The device may further include a motor body receiving at least a portion of the drive assembly, where the motor body includes a stop surface and the lever actuation member includes a motor body contact surface. The motor body contact surface of the lever actuation member may be engaged with the stop surface of the motor body when the lever actuation member is in the locked position and disengaged from the stop surface of the motor body when the lever actuation member is in the released position. The stop surface of the motor body may define a planar surface and the motor body contact surface of the lever actuation member may define a cylindrical surface.

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>. 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 opening <NUM> is cylindrical and the portion of the plunger body <NUM> defining the rotation axis <NUM> is also cylindrical to allow for the smooth rotation of the lever actuation member <NUM> between the locked position and the released position. 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>, which allows the device <NUM> to be more compact and to provide a stronger drive member to inject high viscosity drugs.

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>. In other words, the drive assembly <NUM> is actuated by movement of the needle cover <NUM> to the actuation position, which causes the lever actuation member <NUM> to rotate to the released position thereby releasing or allowing the drive assembly <NUM> to move into engagement with the stopper <NUM> and dispense medicament from the barrel <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>. 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>. The cap <NUM> may include one or more components received within the outer portion <NUM> to facilitate removal of the RNS <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 <NUM> 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, 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 <NUM>.

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>. 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>. The cover stop <NUM> also restricts axial movement of the needle cover <NUM> in the post-use position of the needle cover <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>, 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. More specifically, as discussed above, the drive assembly <NUM> is actuated by movement of the needle cover <NUM> to the actuation position, which causes the lever actuation member <NUM> to rotate to the released position thereby releasing or allowing the drive assembly <NUM> to move into engagement with the stopper <NUM> and dispense medicament from the barrel <NUM>. Removal of the cap <NUM> from the device <NUM> allows for the actuation of the device <NUM>. 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>. As shown in <FIG>, the restriction surface <NUM> is spaced from the needle shield <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 <NUM> 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 <NUM> also includes a needle cover contact surface <NUM>, a motor body contact surface <NUM>, and defines a recessed area <NUM>.

Referring to <FIG> and <FIG>, 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 lever contact portion <NUM> is preferably located on a lever actuation arm <NUM> of the needle cover <NUM>, located at a distal end or at a proximal end of the needle cover <NUM>. The lever actuation arm <NUM> preferably protrudes radially from a proximal end of the needle cover <NUM>. The lever contact portion <NUM> of the needle cover <NUM> defines a cylindrical surface <NUM> and the needle cover contact surface <NUM> of the lever actuation member <NUM> defines a planar surface <NUM>. The engagement between the cylindrical surface <NUM> of the lever contact portion <NUM> and the planar surface <NUM> of the needle cover contact surface <NUM> reduces the amount of effort required to rotate the lever actuation member <NUM>. 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 stop surface <NUM> of the motor body <NUM> defines a planar surface <NUM> and the motor body contact surface <NUM> of the lever actuation member <NUM> defines a cylindrical surface <NUM>. The engagement between the planar surface <NUM> of the stop surface <NUM> and the cylindrical surface <NUM> of the motor body contact surface <NUM> reduces the amount of effort required to rotate the lever actuation member <NUM>.

Referring to <FIG>, 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, which ensures the actuation of the device <NUM>. 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 <NUM> 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.

Referring to <FIG> and <FIG>, the syringe holder <NUM> further includes a securing ring <NUM> configured to receive and secure the syringe assembly <NUM>. In particular, the securing ring <NUM> is positioned at one end of the syringe holder <NUM> with the barrel <NUM> of the syringe assembly <NUM> extending through the securing ring <NUM>. A flange of the barrel <NUM> abuts the securing ring <NUM>. The securing ring <NUM> is formed from a thermoplastic elastomer, although other suitable materials may be utilized.

Referring to <FIG> and <FIG>, the audio indicator member <NUM> is also configured to restrict movement of the syringe holder <NUM> when the plunger body <NUM> is in the pre-use position. As discussed above, the lever actuation member <NUM> prevents movement of the plunger body <NUM> and the syringe holder <NUM> is moveable relative to the cassette body <NUM>. The audio indicator member <NUM> engages at least one arm <NUM> of the syringe holder <NUM> to prevent movement of the syringe holder <NUM> during movement of the device <NUM> in the pre-use position or during removal of the cap <NUM>. The arm(s) <NUM> extend radially outward from the syringe holder <NUM> with a portion of the audio indicator member <NUM> positioned between the arm(s) <NUM> of the syringe holder <NUM> such that movement of the syringe holder <NUM> in a direction extending from the second subassembly <NUM> toward the first subassembly <NUM> causes at least one of the arm(s) <NUM> to engage the audio indicator member <NUM> to restrict any further movement of the syringe holder <NUM>.

Referring to <FIG>, <FIG>, <FIG>, and <FIG>, as mentioned above, the device <NUM> also includes a visual indicator member <NUM> configured to provide a visual indication of a transition of the plunger body <NUM> from the injection position (<FIG>) to the post-use position (<FIG>). The visual indicator member <NUM> is visible via the indicator opening <NUM> defined by the lower housing shell <NUM>. The visual indicator <NUM> member is formed integrally with the plunger body <NUM> and spaced from the audio indicator member <NUM>, although other suitable configurations may be utilized. As noted above, the visual indicator member <NUM> may utilize contrasting colors, symbols, patterns, or any other suitable visual indicia to indicate the various statuses of the device. The lever opening <NUM> of the plunger body <NUM> is positioned between the audio indicator member <NUM> and the visual indicator member <NUM>, although other suitable configurations may be utilized.

Referring to <FIG>, the cassette body <NUM> defines at least one guiding groove <NUM> extending along a longitudinal axis of the cassette body <NUM>. The guide groove(s) <NUM> receives the arm(s) <NUM> of the needle cover <NUM> and guides the movement of the needle cover <NUM> within the device <NUM> and relative to the cassette body <NUM> between the pre-use position, the actuation position, and the post-use position. The guide groove(s) <NUM> fixes the transverse position of the needle cover <NUM> to ensure that the lever contact portion <NUM> of the needle cover <NUM> stays aligned with the needle cover contact surface <NUM> of the lever actuation member <NUM> thereby ensuring the lever contact portion <NUM> engages the needle cover contact surface <NUM> when the needle cover <NUM> moves to the actuation position.

Referring to <FIG>, <FIG>, the motor body <NUM> includes arm <NUM> extending from the motor body <NUM>. As shown in <FIG>, the arm <NUM> is configured to engage a flange <NUM> of the barrel <NUM> of the syringe assembly <NUM>. Accordingly, the barrel <NUM> of the syringe assembly <NUM> constrained at one end by the syringe holder <NUM> and at the other end by the arm <NUM> of the motor body <NUM> thereby securing the syringe assembly <NUM> within the syringe holder <NUM>. The motor body <NUM> includes a pair of arms <NUM> on each side of the motor body <NUM>, although the motor body <NUM> may include one or more arms <NUM>. The arms <NUM> are L-shaped, although other suitable shapes and configurations may be utilized.

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.

Elements of one disclosed aspect can be combined with elements of one or more other disclosed aspects to form different combinations, all of which are considered to be within the scope of the present invention.

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>);
with:
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; and
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 drive assembly (<NUM>) is actuated, and a post-use position where the cannula (<NUM>) is positioned within the needle cover (<NUM>), the needle cover (<NUM>) being configured to engage the lever actuation member (<NUM>) and move the lever actuation member (<NUM>) to the released position when the needle cover (<NUM>) is moved into the actuation position, characterized in that the needle cover (<NUM>) prevents movement 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.