Drug delivery device

Abstract

A drug delivery device comprising: a housing; a syringe assembly comprising a barrel, a bung, a cannula, and a rigid needle guard that receives at least a portion of the cannula, wherein at least a portion of the syringe assembly is located within the housing; a drive assembly, at least a portion of the drive assembly is located within the housing; a cap secured to the housing, wherein the cap comprises an outer portion that defines an interior space and a retainer, the retainer comprising a main body having a removal protrusion configured to remove the rigid needle guard upon axial movement of the outer portion of the cap away from the housing; and a needle cover having a pre-use position, an actuated position, and a post-use position. The outer portion receives a portion of the needle cover, wherein the outer portion is configured to prevent movement of the needle cover from the pre-use position to the actuated position.

Description

[0001] This application is a divisional application of Chinese invention patent application No. 202080016912.1, which is entitled "Automatic Injector with Cap" and whose international application date is February 26, 2020, PCT / EP2020 / 055008 and has entered the Chinese national phase. Technical Field

[0002] This disclosure generally relates to a drug delivery device, and more particularly to an autoinjector. Background Technology

[0003] Various types of automated injection devices have been developed to allow untrained personnel to administer drug solutions and other liquid therapeutic preparations or to self-inject. Typically, these devices include a reservoir pre-filled with the liquid therapeutic preparation and some type of automated needle injection mechanism that can be triggered by the user. Many of these devices, such as autoinjectors, are designed to assemble the reservoir, such as a pre-filled syringe, into the device during device assembly. In addition to automated needle injection mechanisms, many drug delivery devices also automatically shield the needle after use to prevent any accidental contact with the needle. Summary of the Invention

[0004] In one aspect, a drug delivery device includes: a housing; a syringe assembly including a syringe barrel, a stopper, a cannula, and a rigid needle guard receiving at least a portion of the cannula, wherein at least a portion of the syringe assembly is positioned within the housing; a drive assembly configured to move the stopper within the syringe barrel upon actuation of the drive assembly, wherein at least a portion of the drive assembly is positioned within the housing; a cap secured to the housing, wherein the cap includes an outer portion defining an internal space and a retainer including a body having a removal protrusion configured to remove the rigid needle guard upon axial movement of the outer portion of the cap away from the housing; and a needle cap having a pre-use position, an actuated position, and a post-use position, wherein in the pre-use position the cannula is positioned within the needle cap, in the actuated position the drive assembly is actuated, and in the post-use position the cannula is positioned within the needle cap. The outer portion receives a portion of the needle cap, wherein the outer portion is configured to prevent the needle cap from moving from the pre-use position to the actuated position.

[0005] The outer portion includes a protrusion received by a cap opening defined by the needle cap, wherein the protrusion of the outer portion is configured to engage the needle cap when the needle cap is moved from the pre-use position to the actuated position.

[0006] A portion of the retainer may be received within the interior space of the outer portion, wherein the retainer is secured to the outer portion and is axially movable relative to the outer portion. The outer portion may include a retaining tab received by a retainer opening defined by the body of the retainer, wherein the retaining tab disengages from the body of the retainer when the outer portion is secured to the housing, and the retaining tab of the outer portion is configured to engage the retainer when the outer portion moves axially away from the housing and when the outer portion moves axially relative to the retainer. The retainer may include a pair of wings extending radially outward from the body of the retainer, wherein each wing is configured to engage a rib extending radially inward from the body of the outer portion.

[0007] The retaining tab can extend radially outward through the retainer opening of the retainer. The retaining tab of the outer portion can be secured to the body of the cap via an extension arm, wherein the retaining tab can move radially inward via the extension arm. The retainer may include a flange that engages with the outer portion when the outer portion is secured to the housing. The flange of the retainer may be spaced apart from the outer portion as the outer portion moves axially away from the housing. The surface from which the protrusion is removed may be planar, and the corresponding surface of the rigid needle guard may also be planar.

[0008] The body of the retainer may include a first end and a second end positioned opposite the first end, wherein a removal extension extends radially inward from the body of the retainer via a removal arm, and the removal arm extends radially inward in a direction extending from the second end of the body to the first end of the body. The removal extension is movable relative to the body of the retainer via the removal arm.

[0009] The device may also include a syringe holder positioned within the housing, wherein the syringe holder receives the syringe assembly and is movable relative to the housing. When the outer portion is secured to the housing, the syringe holder can disengage from the drive assembly, wherein the syringe holder engages with the drive assembly as the outer portion moves axially away from the housing.

[0010] The surface from which the protrusion is removed can be configured to engage a corresponding surface of the rigid needle guard to remove the rigid needle guard as the outer portion of the cap moves axially away from the housing, wherein the surface from which the protrusion is removed disengages from the corresponding surface of the rigid needle guard when the outer portion is secured to the housing. The protrusion can be configured to be removed from the cap opening before the surface from which the protrusion is removed engages with the corresponding surface of the rigid needle guard as the outer portion moves axially away from the housing.

[0011] The outer portion may include one of a locking protrusion and a locking recess, and the housing may include the other of a locking protrusion and a locking recess, wherein the locking protrusion is received by the locking recess to secure the outer portion to the housing, and wherein the locking protrusion separates from the locking recess before the corresponding surface of the rigid needle guard is engaged on the surface of the removed protrusion when the outer portion moves axially away from the housing.

[0012] The device may include one or more of the following features, either individually or according to all possible combinations of technologies:

[0013] - A drug delivery device may include: a housing; a syringe assembly including a syringe barrel, a stopper, a cannula, and a rigid needle guard receiving at least a portion of the cannula, at least a portion of the syringe assembly being positioned within the housing; a drive assembly configured to move the stopper within the syringe barrel upon actuation of the drive assembly, at least a portion of the drive assembly being positioned within the housing; and a cap attached to the housing, the cap including an outer portion defining an internal space and a retainer including a body having a removal protrusion configured to remove the rigid needle guard upon axial movement of the outer portion of the cap away from the housing; and a needle cap having a pre-use position, an actuated position, and a post-use position, wherein in the pre-use position the cannula is located within the needle cap, in the actuated position the drive assembly is actuated, and in the post-use position the cannula is located within the needle cap, wherein the outer portion receives a portion of the needle cap, the outer portion being configured to prevent the needle cap from moving from the pre-use position to the actuated position;

[0014] - The outer portion may include a protrusion received by a cap opening defined by the needle cap, the protrusion of the outer portion being configured to engage the needle cap when the needle cap is moved from the pre-use position to the actuated position.

[0015] - A portion of the retainer can be received within the inner space of the outer portion of the cap, and the retainer is fixed to the outer portion and is axially movable relative to the outer portion.

[0016] - The outer portion may include a retaining tab that is received by a retainer opening defined by the body of the retainer. When the outer portion is secured to the housing, the retaining tab disengages from the body of the retainer. The retaining tab of the outer portion is configured to engage the retainer when the outer portion moves axially away from the housing and when the outer portion moves axially relative to the retainer.

[0017] - The retainer may include a pair of wings extending radially outward from the body of the retainer, each wing being configured to engage a rib extending radially inward from the body of the outer portion;

[0018] - The retaining tab can extend radially outward through the retainer opening of the retainer;

[0019] - The retaining tab of the outer part can be fixed to the body of the outer part by the extension arm, and the retaining tab can be moved radially inward by the extension arm;

[0020] - The retainer may include a flange that engages with the outer portion when the outer portion is secured to the housing.

[0021] - The retainer flange can be spaced apart from the outer portion when the outer portion moves axially away from the housing;

[0022] - The surface from which the protrusion is removed can be flat, and the corresponding surface of the rigid needle guard is flat.

[0023] - The body of the retainer may include a first end and a second end positioned opposite to the first end. The removal extension extends radially inward from the body of the retainer via a removal arm, which extends radially inward and in a direction from the second end of the body to the first end of the body.

[0024] - The extension can be removed by moving the removal arm relative to the body of the retainer;

[0025] - A syringe holder may be positioned within a housing, the syringe holder receiving a syringe assembly, the syringe holder being movable relative to the housing, wherein the syringe holder is disengaged from the drive assembly when the outer portion is secured to the housing, and wherein the syringe holder engages with the drive assembly when the outer portion moves axially away from the housing.

[0026] - The surface from which the protrusion is removed can be configured to engage with the corresponding surface of the rigid needle guard so that the rigid needle guard is removed when the outer portion of the cap moves away from the housing axially, and when the outer portion is fixed to the housing, the surface from which the protrusion is removed disengages from the corresponding surface of the rigid needle guard.

[0027] - The outer portion may include either a locking protrusion or a locking recess, and the housing includes the other of the locking protrusion and the locking recess. The locking protrusion is received by the locking recess to secure the outer portion to the housing, and wherein the locking protrusion separates from the locking recess before the corresponding surface of the rigid needle guard is engaged on the surface of the removed protrusion when the outer portion moves axially away from the housing.

[0028] - A drug delivery device may include: a housing; a syringe assembly including a syringe barrel, a stopper, a cannula, and a rigid needle guard receiving at least a portion of the cannula, at least a portion of the syringe assembly being positioned within the housing; a drive assembly configured to move the stopper within the syringe barrel when the drive assembly is actuated, at least a portion of the drive assembly being positioned within the housing; and a cap attached to the housing, the cap including an outer portion defining an internal space and a retainer including a body having a removal protrusion, wherein a surface of the removal protrusion is configured to engage a corresponding surface of the rigid needle guard to remove the rigid needle guard when the outer portion of the cap is moved axially away from the housing, and when the outer portion is attached to the housing, the surface of the removal protrusion disengages from the corresponding surface of the rigid needle guard;

[0029] - A drug delivery device may include: a housing; a syringe assembly including a syringe barrel, a stopper, a cannula, and a rigid needle guard receiving at least a portion of the cannula, at least a portion of the syringe assembly being positioned within the housing; a drive assembly configured to move the stopper within the syringe barrel when the drive assembly is actuated, at least a portion of the drive assembly being positioned within the housing; and a cap attached to the housing, the cap including an outer portion defining an internal space and a retainer including a body having a removable protrusion, wherein a portion of the retainer is received within the internal space of the outer portion of the cap, and wherein the retainer is attached to the outer portion and is axially movable relative to the outer portion, the outer portion including a retaining tab received by a retainer opening defined by the body of the retainer, the retaining tab disengaging from the body of the retainer when the outer portion is attached to the housing, the retaining tab of the outer portion being configured to engage the retainer when the outer portion is axially moved away from the housing and when the outer portion is axially moved relative to the retainer;

[0030] - A drug delivery device may include: a housing; a syringe assembly including a syringe barrel, a stopper, a cannula, and a rigid needle guard receiving at least a portion of the cannula, at least a portion of the syringe assembly being positioned within the housing; a drive assembly configured to move a stopper within the syringe barrel upon actuation of the drive assembly, at least a portion of the drive assembly being positioned within the housing; a cap attached to the housing including an outer portion defining an internal space and a retainer including a body having a removable protrusion; and a syringe holder positioned within the housing receiving the syringe assembly, the syringe holder being movable relative to the housing, wherein the syringe holder disengages from the drive assembly when the outer portion is attached to the housing, and wherein the syringe holder engages with the drive assembly as the outer portion moves axially away from the housing. Attached Figure Description

[0031] The above and other features and advantages of this disclosure, and the ways in which they are obtained, will become more apparent from the following description, taken in conjunction with the accompanying drawings, and the disclosure itself will be better understood, wherein:

[0032] Figure 1A This is a perspective view of a drug delivery device according to one aspect of this application, showing the storage location of the device.

[0033] Figure 1B This is a perspective view of the drug delivery device in Figure 1, showing the device in its pre-use position.

[0034] Figure 2A Figure 1 is a cross-sectional view of the drug delivery device, showing the storage location of the device.

[0035] Figure 2B Figure 1 is a cross-sectional view of the drug delivery device, showing the device in its pre-use position.

[0036] Figure 3 This is a perspective view of the drug delivery device in Figure 1, showing the actuation position of the device.

[0037] Figure 4 Figure 1 is a cross-sectional view of the drug delivery device, showing the actuation position of the device.

[0038] Figure 5 This is a perspective view of the drug delivery device in Figure 1, showing the injection site of the device.

[0039] Figure 6 Figure 1 is a cross-sectional view of the drug delivery device, showing the injection site of the device.

[0040] Figure 7 This is a perspective view of the drug delivery device in Figure 1, showing the device in its post-use position.

[0041] Figure 8 Figure 1 is a cross-sectional view of the drug delivery device, showing the device in its post-use position.

[0042] Figure 9 This is a perspective view of the drug delivery device in Figure 1, showing the locking clip.

[0043] Figure 10 This is an exploded perspective view of the drug delivery device in Figure 1, showing the locking clip.

[0044] Figure 11A This is a partial cross-sectional view of the drug delivery device in Figure 1, showing the locking arm of the housing.

[0045] Figure 11B yes Figure 11AAn enlarged cross-sectional view of the region shown.

[0046] Figure 12 Figure 1 is a cross-sectional view of the drug delivery device, showing the post-use position of the device before complete drug delivery.

[0047] Figure 13A Figure 1 shows a partial cross-sectional view of the drug delivery device, which illustrates the cap of the device.

[0048] Figure 13B yes Figure 13A An enlarged cross-sectional view of the region shown.

[0049] Figure 14 Figure 1 shows a partial cross-sectional view of the drug delivery device, illustrating the lever actuation component when the device is in the storage position.

[0050] Figure 15A Figure 1 shows a partial cross-sectional view of the drug delivery device, illustrating the storage location of the device and the movement of the needle cap.

[0051] Figure 15B yes Figure 15A An enlarged cross-sectional view of the region shown.

[0052] Figure 15C yes Figure 15A An enlarged cross-sectional view of the region shown.

[0053] Figure 16 This is a perspective view of a lever actuation member according to one aspect of this application.

[0054] Figure 17A Figure 1 is a cross-sectional view of the drug delivery device, showing the storage location of the device.

[0055] Figure 17B yes Figure 17A An enlarged cross-sectional view of the region shown.

[0056] Figure 17C yes Figure 17A An enlarged cross-sectional view of the region shown.

[0057] Figure 17D yes Figure 17A An enlarged cross-sectional view of the region shown.

[0058] Figure 17E yes Figure 17A An enlarged cross-sectional view of the region shown.

[0059] Figure 17F yes Figure 17A An enlarged cross-sectional view of the region shown.

[0060] Figure 18A Figure 1 shows a partial cross-sectional view of the drug delivery device, illustrating the initial removal of the device's cap.

[0061] Figure 18B yes Figure 18A An enlarged cross-sectional view of the region shown.

[0062] Figure 18C yes Figure 18A An enlarged cross-sectional view of the region shown.

[0063] Figure 18D yes Figure 18A An enlarged cross-sectional view of the region shown.

[0064] Figure 18E yes Figure 18A An enlarged cross-sectional view of the region shown.

[0065] Figure 18F yes Figure 18A An enlarged cross-sectional view of the region shown.

[0066] Figure 19A Figure 1 shows a partial cross-sectional view of the drug delivery device, illustrating the removal of the device's cap.

[0067] Figure 19B yes Figure 19A An enlarged cross-sectional view of the region shown.

[0068] Figure 19C yes Figure 19A An enlarged cross-sectional view of the region shown.

[0069] Figure 19D yes Figure 19A An enlarged cross-sectional view of the region shown.

[0070] Figure 19E yes Figure 19A An enlarged cross-sectional view of the region shown.

[0071] Figure 19F yes Figure 19A An enlarged cross-sectional view of the region shown.

[0072] Figure 20A Figure 1 shows a partial cross-sectional view of the drug delivery device, illustrating the removal of the device's cap.

[0073] Figure 20B yes Figure 20A An enlarged cross-sectional view of the region shown.

[0074] Figure 20C yes Figure 20A An enlarged cross-sectional view of the region shown.

[0075] Figure 20D yes Figure 20A An enlarged cross-sectional view of the region shown.

[0076] Figure 20E yes Figure 20A An enlarged cross-sectional view of the region shown.

[0077] Figure 20F yes Figure 20A An enlarged cross-sectional view of the region shown.

[0078] Figure 21A Figure 1 shows a partial cross-sectional view of the drug delivery device, illustrating the removal of the device's cap.

[0079] Figure 21B yes Figure 21A An enlarged cross-sectional view of the region shown.

[0080] Figure 21C yes Figure 21A An enlarged cross-sectional view of the region shown.

[0081] Figure 21D yes Figure 21A An enlarged cross-sectional view of the region shown.

[0082] Figure 21E yes Figure 21A An enlarged cross-sectional view of the region shown.

[0083] Figure 21F yes Figure 21A An enlarged cross-sectional view of the region shown.

[0084] Figure 22A Figure 1 shows a partial cross-sectional view of the drug delivery device, illustrating the removal of the device's cap.

[0085] Figure 22B yes Figure 22A An enlarged cross-sectional view of the region shown.

[0086] Figure 22C yes Figure 22A An enlarged cross-sectional view of the region shown.

[0087] Figure 22D yes Figure 22A An enlarged cross-sectional view of the region shown.

[0088] Figure 22E yes Figure 22A An enlarged cross-sectional view of the region shown.

[0089] Figure 22F yes Figure 22A An enlarged cross-sectional view of the region shown.

[0090] Figure 23 This is a perspective view of a cap, retainer, and rigid needle guard according to one aspect of this application.

[0091] Figure 24 This is a perspective view of a retainer according to one aspect of this application.

[0092] Figure 25 This is a perspective view of a drug delivery device according to another aspect of this application, showing the storage location of the device.

[0093] Figure 26 It is along Figure 25 The cross-sectional view shown is taken by line 26-26.

[0094] Figure 27 yes Figure 25 A top-down perspective view of the motor body of the drug delivery device.

[0095] Figure 28 yes Figure 27 A bottom-view perspective view of the motor body.

[0096] Figure 29 yes Figure 25 A front perspective view of the plunger body of a drug delivery device.

[0097] Figure 30 yes Figure 29 Rear perspective view of the plunger body.

[0098] Figure 31 yes Figure 25 A front perspective view of the plunger section of a drug delivery device.

[0099] Figure 32 yes Figure 31 Rear perspective view of the plunger rod section.

[0100] Figure 33 yes Figure 25 A top perspective view of the lever actuation component of a drug delivery device.

[0101] Figure 34 yes Figure 33 A bottom perspective view of the lever actuation component of a drug delivery device.

[0102] Figure 35 yes Figure 25 Front perspective view of the syringe holder of the drug delivery device.

[0103] Figure 36 yes Figure 35 Rear perspective view of the syringe holder of the drug delivery device.

[0104] Figure 37 yes Figure 25A front perspective view of the needle cap of a drug delivery device.

[0105] Figure 38 yes Figure 37 Rear perspective view of the needle cap of the drug delivery device.

[0106] Figure 39 yes Figure 25 A top-view perspective view of the casing of the drug delivery device.

[0107] Figure 40 yes Figure 39 A bottom perspective view of the casing of the drug delivery device.

[0108] Figure 41 yes Figure 25 A top-down perspective view of the cap of the drug delivery device.

[0109] Figure 42 It is along Figure 41 The cross-sectional view taken from line 42-42 in the diagram.

[0110] Figure 43 yes Figure 25 A perspective view of the holder of the drug delivery device.

[0111] Figure 44 yes Figure 25 A cross-sectional view of the housing on the outer shell of the drug delivery device.

[0112] Figure 45 yes Figure 25 A perspective view of the lower housing of the drug delivery device.

[0113] Figure 46 It is along Figure 45 The cross-sectional view taken from line 46-46 in the diagram.

[0114] Figure 47 yes Figure 25 A cross-sectional view of the drug delivery device, showing the injection site of the device.

[0115] Figure 48 yes Figure 25 A partial cross-sectional view of a drug delivery system.

[0116] Figure 49 yes Figure 25 A cross-sectional view of a drug delivery system.

[0117] Throughout these views, corresponding reference numerals denote corresponding parts. The examples illustrated herein illustrate exemplary aspects of this disclosure, and these examples should not be construed as limiting the scope of this disclosure in any way. Detailed Implementation

[0118] The following description is provided to enable those skilled in the art to make and use the described concepts to implement embodiments of the invention. However, various modifications, equivalents, variations, and substitutions will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0119] For the purposes described below, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives should be understood in relation to the orientation of the invention as shown in the accompanying drawings. However, it should be understood that the invention may take various alternative variations unless expressly stated otherwise. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0120] Reference Figure 1A-10 According to one aspect of the invention, a drug delivery device 10 includes a first sub-assembly 12, a second sub-assembly 14, and a syringe assembly 16. The first sub-assembly 12 includes a cap 18 having an outer portion 20, a needle cap 22, a syringe holder 24, a housing 26, and a lower housing 28. The second sub-assembly 14 includes a drive assembly 40, a motor body 42, a lever actuation member 44, and an upper housing 46. The syringe assembly 16 is received by the syringe holder 24 and includes a syringe barrel 52, a stopper 54, a cannula 56, and a rigid needle guard (RNS) 58. While a rigid needle guard is used, other suitable needle guard configurations may also be used. The lower housing 28, the housing 26, and the upper housing 46 integrally form the housing for the various components of the receiving device 10, but other suitable housing configurations may also be used. As discussed in more detail below, the first sub-assembly 12 and the second sub-assembly 14 are secured to each other during assembly by locking clips 64, but other suitable configurations may also be used. The drug delivery device 10 may be an autoinjector, but the features described herein may also be incorporated into other suitable drug delivery devices.

[0121] The drug delivery device 10 is configured to automatically deliver a dose of medication from the syringe assembly 16 to a patient when the device 10 is actuated. More specifically, when the drug delivery device 10 is actuated, the drive assembly 40 is configured to engage the stopper 54 of the syringe assembly 16, displacing the syringe assembly 16 so that the cannula 56 punctures the patient's skin, and displacing the stopper 54 within the syringe barrel 52 of the syringe assembly 16 to deliver the medication within the syringe barrel 52. The drug delivery device 10 includes a storage location ( Figure 1A and 2A ), position before use ( Figure 1B and 2B ), Actuation position ( Figure 3 and 4 ), injection site ( Figure 5 and 6 ) and post-use location ( Figure 7 and 8 As discussed in more detail below, when the device 10 is in the pre-use and post-use positions, the needle cap 22 is configured to shield the cannula 56 of the syringe assembly 16 from the patient. Specifically, the needle cap 22 is movable between a pre-use position, an actuated position, and a post-use position, wherein a spring 68 biases the needle cap 22 toward the pre-use and post-use positions. The spring 68 is located between the needle cap 22 and the syringe holder 24, but other suitable configurations may also be used. The lever actuation member 44 is movable between a locked position that prevents movement of the drive assembly 40 and a released position that allows movement of the drive assembly 40. More specifically, the lever actuation member 44 is rotatable about a rotation axis 70 between the locked and released positions. When the lever actuation member 44 is in the locked position, it engages with the motor body 42 and the drive assembly 40 to prevent movement of the drive assembly 40. When the lever actuation member 44 is in the released position, it disengages from the motor body 42, thereby allowing movement of the drive assembly 40 toward the syringe assembly 16. The rotation axis 70 of the lever actuation member 44 extends perpendicular to the longitudinal axis of the device 10, but other suitable configurations may also be used.

[0122] Referring again to Figures 1-10, the drive assembly 40 includes a plunger body 80 having a plunger rod portion 82 and a drive member 84. The drive member 84 is a compression spring received within a drive opening 86 defined by the plunger body 80; however, other suitable drive members may be used, including but not limited to compressed gas, an electric motor, hydraulic pressure, other types of springs, etc. The drive member 84 engages the plunger body 80 and the motor body 42 and biases the plunger body 80 in a direction extending from the second sub-assembly 14 toward the first sub-assembly 12. The plunger body 80 defines a lever opening 88 that receives the lever actuation member 44 and defines the axis of rotation 70 of the lever actuation member 44. The lever actuation member 44 prevents the plunger body 80 from moving when the lever actuation member 44 is in a locked position through engagement with the motor body 42. When the lever actuation member 44 rotates from the locked position to the released position, the lever actuation member 44 disengages from the motor body 42, thereby allowing the drive member 84 to move the plunger body 80 and the plunger rod portion 82 toward the first sub-assembly 12. The plunger rod portion 82 and the drive member 84 are spaced apart from each other and parallel to each other and extend in the longitudinal direction of the device 10.

[0123] The drive assembly 40 also includes a spring guide member 90 fixed to the upper housing 46 and received within a drive opening 86 of the plunger body 80. The drive member 84 is received by the spring guide member 90 such that it is positioned between the plunger body 80 and the spring guide member 90. The drive assembly 40 also includes a plunger rod cap 92 that receives a plunger rod portion 82 of the plunger body 80. The plunger rod cap 92 is configured to guide the plunger rod portion 82 into the syringe barrel 52 of the syringe assembly 16 and engage the stopper 54 of the syringe assembly 16 to dispense medication from the syringe barrel 52 of the syringe assembly 16. The plunger rod cap 92 and the plunger rod portion 82 may be integrally formed or each may be formed as separate components.

[0124] The plunger body 80 of the drive assembly 40 also includes an audible indicator member 94 configured to provide an audible indication to the user when the device 10 is switched to the post-use position. As discussed in more detail below, the audible indicator member 94 is configured to engage one or more ribs 96 of the housing 26 when the device 10 is in the injection position, thereby deflecting the audible indicator member 94. When the drug delivery device 10 is switched from the injection position to the post-use position, the audible indicator member 94 disengages from the ribs (or ribs) 96 of the housing 26 and contacts the lower housing 28 of the outer casing to provide an audible click, although the audible indicator member 94 may also contact other suitable parts of the device 10 to provide an audible indication.

[0125] Reference Figure 1A-2B In the storage position, the cap 18 is secured to the lower housing 28 and engages with the needle cap 22. Movement of the needle cap 22 from the pre-use position to the actuated position causes engagement between the needle cap 22 and the lever actuation member 44, thereby actuating the drive assembly 40. After removing the cap 18 by grasping the outer portion 20, the needle cap 22 can be moved from the pre-use position to the actuated position by pressing the needle cap 22 against the patient's skin surface and axially pressing the device 10 against the skin surface. As detailed below, the engagement between the cap 18 and the needle cap 22 prevents the needle cap 22 from moving into engagement with the lever actuation member 44. Therefore, removing the cap 18 from the device 10 allows actuation of the device 10. As discussed in more detail below, Figure 1B and 2B As shown, the cannula 56 is exposed by removing the cap 18 from the device 10 and the rigid needle guard 58 from the syringe barrel 52, which was still received in the needle cap 22 in the pre-use position of the device 10.

[0126] Reference Figure 3 and 4In the actuated position, the cap 18 is removed and the needle cap 22 is positioned in the actuated position by engaging with the patient's skin surface, which causes the needle cap 22 to move further within the device 10 toward the second sub-assembly 14. When the needle cap 22 has moved a sufficient distance within the device 10, a portion of the needle cap 22 engages the lever actuation member 44, which causes the lever actuation member 44 to rotate about the rotation axis 70 from the locked position to the released position.

[0127] Reference Figure 5 and Figure 6 In the injection position, the lever actuation member 44 is in the released position, which allows the plunger body 80 of the drive assembly 40 to move toward the first sub-assembly 12, such that the plunger body 80 or plunger rod cap 92 engages the stopper of the syringe assembly 16. The initial engagement of the drive assembly 40 with the syringe assembly 16 causes the syringe assembly 16 and syringe holder 24 to move relative to the housing 26 within the device 10 until the syringe holder 24 abuts against the stop 102 defined by the housing 26. During the initial movement of the syringe assembly 16 and syringe holder 24 (where the needle cap 22 presses against the patient's skin surface), the cannula 56 of the syringe assembly 16 extends beyond the needle cap 22 and pierces the patient's skin surface. Further movement of the plunger body 80, driven by the drive member 84, causes the stopper 54 to move relative to the syringe barrel 52 of the syringe assembly 16 to dispense medication from the syringe barrel 52 of the syringe assembly 16 into the patient through the cannula 56. The plunger body 80 continues to move until the stopper 54 bottoms out on the syringe 52 of the syringe assembly 16. As the stopper 54 bottoms out, or just before it does, the audible indicator member 94 disengages from the ribs (or ribs) 96 of the housing 26 and contacts the lower housing 28 substantially simultaneously to provide the patient with an audible indication that a dose of medication has been delivered. In addition to the audible indication, the medication delivery device 10 provides one or more visual indicators to notify the patient of the status of the device 10. Specifically, the housing 26 may be formed of a transparent material to allow visual confirmation of the movement of the stopper 54 and / or the movement of another visual indicator provided by the drive assembly 40, the syringe holder 24, and / or the syringe assembly 16. The lower housing 28 also defines an indicator opening 104, which provides a visual indication that the plunger body 80 is in its final position and a dose of medication has been delivered. The visual indicators may utilize contrasting colors, symbols, patterns, or any other suitable visual markings to indicate various states of the device.

[0128] Reference Figure 7 , 8 11A, 11B, and 12, in the post-use position, when the needle cap 22 is removed from the patient's skin surface, the needle cap 22 extends to the post-use position to shield the cannula 56. (See also...) Figure 11BAs shown more clearly, housing 26 includes at least one locking arm 106, and needle cap 22 includes at least one locking protrusion 108, although other suitable configurations may also be used. The locking arm 106 of housing 26 engages the locking protrusion 108 of needle cap 22 to prevent any further use of device 10 and to prevent exposure of the cannula 56 of syringe assembly 16. During the transition of device 10 from the injection position to the post-use position, the locking arm 106 of housing 26 deflects to allow the locking protrusion 108 of needle cap 22 to pass over housing 26, while the locking arm 106 returns to its original position to prevent needle cap 22 from moving back toward the pre-use and actuated positions. In the pre-use position of needle cap 22, a portion of needle cap 22 engages the cap stop 110 of syringe holder 24 to limit axial movement of needle cap 22 in a direction extending from the second sub-assembly 14 toward the first sub-assembly 12. After use of device 10, syringe holder 24 is displaced within housing 26 relative to needle cap 22, allowing needle cap 22 to extend to its post-use position when the patient removes it from the skin surface. Figure 12 As shown, when the needle cap 22 is removed from the patient's skin, the needle cap 22 will move to the post-use position, regardless of the position of the stopper 54 within the syringe barrel 52 of the syringe assembly 16. Therefore, if the patient removes the needle cap 22 from the skin after only a portion of the medication has been delivered, the needle cap 22 will still move to the post-use position and will prevent further use of the device 10.

[0129] Reference Figure 1A , 1B As described above in 13A-15C, the engagement between the cap 18 and the needle cover 22 prevents the needle cover 22 from moving into engagement with the lever actuation member 44. When the needle cover 22 is in the pre-use and post-use positions, the sleeve 56 is positioned within the needle cover 22. The needle cover 22 is configured to actuate the drive assembly 40 when the needle cover 22 is in the actuated position. Actuation of the device 10 is permitted by removing the cap 18 from the device 10. More precisely, in one aspect of this application, the outer portion 20 of the cap 18 includes a body 116 defining an internal space 118 that receives a portion of the needle cover 22 when the device 10 is in the storage position, wherein the outer portion 20 is secured to the lower housing 28 of the outer casing. The outer portion 20 of the cap 18 is secured to the lower housing 28 by a locking protrusion 112 received by a locking recess 114 defined by the body 116 of the outer portion 20 of the cap 18. The outer portion 20 also includes a gripping surface 130 to facilitate gripping of the outer portion 20 of the cap 18 and the outer portion for removing the cap from the lower housing 28 of the outer housing.

[0130] The outer portion 20 includes a pair of protrusions 120 received by a cap opening 122 defined by the needle cap 22, but one or more protrusions 120 and one or more cap openings 122 may also be used. The protrusions 120 of the outer portion 20 are configured to engage the needle cap 22 when the needle cap 22 is moved from a pre-use position to an actuated position. For example, when the device 10 is in the storage position and the outer portion 20 is secured to the lower housing 28, if the device 10 is dropped or impacted, applying force to the needle cap 22, the lever actuation member 44, and / or other components, the protrusions 120 of the outer portion 20 restrict the movement of the needle cap 22, preventing any accidental actuation of the device 10. The protrusions 120 of the outer portion 20 may be movable in the radial direction via an extension arm 124 of the outer portion 20. Figure 13B As shown, for example, the engagement between the extension arm 124 and the lower housing 28 prevents the protrusion 120 from moving radially outward. More precisely, the lower housing 28 includes a skirt configured to surround the extension arm 124 of the outer portion 20 when the outer portion 20 is mounted on the lower housing 28, thereby preventing the protrusion 120 from moving radially outward as long as the outer portion 20 is mounted on the lower housing 28. The protrusion 120 is configured to be removed from the cap opening 122 of the needle cap 122 during axial movement of the outer portion 20. In particular, the protrusion 120 is configured to engage the needle cap 22 and deflect radially outward during axial movement of the outer portion 20 of the cap 18.

[0131] Reference Figure 13B Each protrusion 120 defines a first cam surface 126, and the pin cap 22 defines a second cam surface 128. The first cam surface 126 is configured to engage the second cam surface 128 such that each protrusion 120 is radially deflected outward, which allows the outer portion 20 to separate from the pin cap 22. The first and second cam surfaces 126, 128 are complementary inclined surfaces, but other suitable configurations may also be used.

[0132] Reference Figure 14-16 When the needle cap 22 is in the pre-use position, the needle cap 22 prevents the lever actuation member 44 from moving or rotating from the locked position to the released position. The lever actuation member 44 includes a body 132 having a limiting surface 134 configured to engage the needle cap 22 and limit rotation of the lever actuation member 44 when the needle cap 22 is in the pre-use position. When the device 10 is in the storage position, if the device 10 is dropped or impacted, applying force to the lever actuation member 44, the lever actuation member 44 is prevented from fully rotating to allow actuation of the drive assembly 40 due to the engagement between the limiting surface 134 of the lever actuation member 44 and the needle cap 22. When the device 10 is in the storage and pre-use positions, the limiting surface 134 is spaced apart from the needle cap 22 to form a gap 136 to prevent any increase in friction during movement of the needle cap 22, while still preventing accidental actuation of the device 10.

[0133] The body 132 of the lever actuation member also includes an assembly surface 138 configured to engage a locking pin (not shown) received by a pin opening 140 defined by the motor body 42. Prior to assembly, the second sub-assembly 14 may include a locking pin extending through the pin opening 140, which prevents rotation of the lever actuation member 44 and accidental actuation of the drive assembly 40 during assembly of the device 10. The body 132 of the lever actuation member also includes a needle cap contact surface 142, a motor body contact surface 144, and defines a recessed region 146. When the needle cap 22 is moved to the actuated position, the needle cap contact surface 142 of the lever actuation member 44 engages the lever contact portion 148 of the needle cap 22, thereby rotating the lever actuation member 44 from the locked position to the released position. When the lever actuation member 44 is in the locked position, the motor body contact surface 144 of the lever actuation member 44 engages the stop surface 150 of the motor body 42, which prevents movement of the plunger body 80. When the lever actuating member 44 rotates from the locked position to the released position, the motor body contact surface 144 disengages from the stop surface 150 of the motor body 42, which allows the drive member 84 to move the plunger body 80.

[0134] The recessed region 146 of the lever actuation member 44 provides a clearance for the lever contact portion 148 of the needle cap 22, allowing the lever actuation member 44 to rotate from the locked position to the released position. When the needle cap 22 is in the pre-use position, the position of the limiting surface 134 of the lever actuation member 44 overlaps with the position of the lever contact portion 148 of the needle cap 22 in the axial direction of the device 10 until the needle cap 22 has been fully moved to the actuated position, which prevents accidental actuation of the device 10 as described above. When the needle cap 22 is fully moved to the actuated position, the lever contact portion 148 of the needle cap 22 no longer overlaps with the position of the limiting surface 134 of the lever actuation member, but instead overlaps with the position of the recessed region 146 in the direction extending along the axial direction of the device 10 and engages the needle cap contact surface 142 to rotate the lever actuation member 44 as described above. The limiting surface 134 of the lever actuation member 44 is planar and configured to engage a corresponding planar surface on the bottom of the needle cap contact surface 142 when the needle cap 22 is in the pre-use position, but other suitable configurations may also be used.

[0135] Reference Figure 17A-24According to one aspect of this application, the device further includes a retainer 160 having a body 162 with a removal protrusion 164 configured to remove the rigid needle guard 58 as the outer portion 20 of the cap 18 moves axially away from the lower housing 28. A portion of the retainer 160 is received within an interior space 118 of the outer portion 20. The outer portion 20 includes a retaining tab 166 received by a retainer opening 168 defined by the body 162 of the retainer 160 to secure the retainer 160 to the outer portion 20. As detailed below, the retaining tab 166 is configured to engage the retainer 160 as the outer portion 20 moves axially away from the lower housing 28. Figure 23 and 24 As shown more clearly, the retainer 160 also includes a pair of wings 170 extending radially outward from the body 162 of the retainer 160, wherein each wing 170 is configured to engage a rib 172 extending radially inward from the body 162 of the outer portion 20. Once the outer portion 20, the retainer 160, and the rigid needle guard 58 have been removed, the wings 170 prevent swaying between the outer portion 20 and the retainer 160.

[0136] like Figure 17C As shown, when the outer portion 20 is secured to the lower housing 28 and the device 10 is in the storage position, the retaining tab 166 of the outer portion 20 disengages from the retainer 160. Figure 20C , 21C As shown in Figure 22C, when the outer portion 20 is secured to the lower housing 28, the retaining tab 166 of the outer portion 20 disengages from the retainer 160. The retaining tab 166 of the outer portion 20 is secured to the body 116 of the outer portion 20 via an extension arm 174. The retaining tab 166 can be moved radially inward via the extension arm 174. When the retaining tab 166 engages the retainer 160, the flexibility of the extension arm 174 facilitates the assembly of the retainer 160 onto the outer portion 20 by allowing the retaining tab 166 to deflect radially inward until the retaining tab 166 is received within the retainer opening 168. The retainer 160 includes a flange 176 that engages with the outer portion 20 when the outer portion 20 is secured to the lower housing 28. As the outer portion 20 moves axially away from the lower housing 28, the flange 176 of the retainer 160 is spaced apart from the outer portion 20.

[0137] like Figure 17EAs shown, the body 162 of the retainer 160 is cylindrical and includes a first end 178 and a second end 180 positioned opposite the first end 178. A removal extension 164 extends radially inward from the body 162 of the retainer 160 via a removal arm 182. The removal arm 182 extends radially inward and in a direction extending from the second end 180 of the body 162 to the first end 178 of the body 162, allowing the retainer 160 to be positioned over the rigid needle guard 58 and the syringe assembly 16 during the outer portion 20 and during the assembly of the retainer 160 onto the device 10. The removal extension 164 is movable relative to the body 162 of the retainer 160 via the removal arm 182. More specifically, the removal extension 164 is radially outward during the assembly of the retainer 160 onto the rigid needle guard 58 and radially inward during the removal of the outer portion 20 and the retainer 160. The removal protrusion 164 includes a surface 184 configured to engage a complementary surface 186 of the rigid needle guard 58. When the outer portion 20 is secured to the lower housing 28, the surface 184 of the removal protrusion 164 of the retainer 160 disengages from the corresponding surface 186 of the rigid needle guard 58. The surface 184 of the removal protrusion 164 is planar, but other suitable shapes and configurations may also be used. The corresponding surface 186 of the rigid needle guard 58 is planar, but other suitable shapes and configurations may also be used. The corresponding surface 186 of the rigid needle guard 58 is defined by a flange portion of the rigid needle guard 58.

[0138] Reference Figure 17F When the outer portion 20 is secured to the lower housing 28, the syringe holder 24 disengages from the plunger body 80 of the drive assembly 40. For example, refer to... Figure 19F As the outer portion 20 of the cap 18 moves axially away from the lower housing 28, the syringe holder 24 engages with the plunger body 80 of the drive assembly 40. More specifically, a pair of arms extend from the syringe holder 24 and engage with the sound indicator member 94 of the plunger body 80, although other suitable configurations may also be used. The engagement between the syringe holder 24 and the plunger body 80 of the drive assembly 40 prevents removal of the outer portion 20 and prevents the rigid needle guard 58 from causing movement of the syringe holder 24 relative to the housing 26. The engagement between the syringe holder 24 and the plunger body 80 also limits axial movement of the syringe holder 24 within the device 10 caused by gravity or movement of the device 10 when the device is in the pre-use position.

[0139] Reference Figure 17A-17F When the device 10 is in the storage position and the outer portion 20 is secured to the lower housing assembly 28, the flange 176 of the retainer 160 abuts against the outer portion 20. Figure 17BThe retaining tab 166 of the outer portion 20 is positioned within the retainer opening 168 and spaced apart from the proximal portion of the body 162 of the retainer 160. Figure 17C The protrusion 120 of the cap is received within the cap opening 122 of the needle cap 22 and spaced apart from the needle cap 22. Figure 17D The surface 184 of the protrusion 164 is separated from the corresponding surface 186 of the rigid needle guard 58. Figure 17E Furthermore, the syringe holder 24 is spaced apart from the plunger body 80 of the drive assembly 40. Figure 17F In the storage position of device 10, retainer 160 engages with syringe holder 24. When the flange 176 of retainer 160 abuts against outer portion 20, the planar surface 184 of removal extension 164 of retainer 160 is properly positioned relative to the complementary surface 186 of rigid needle guard 58. In other words, the abutment of flange 176 against outer portion 20 ensures that retainer 160 is positioned sufficiently axially toward lower housing 28 to allow removal of rigid needle guard 58 as described below.

[0140] Reference Figures 18A-18F As the outer portion 20 initially moves axially away from the lower housing 28 ( Figure 18B Furthermore, the locking protrusion 112 is only partially received within the locking recess 114, the flange 176 of the retainer 160 is spaced apart from the outer portion 20, and the retaining tab 166 remains spaced apart from the body 162 of the retainer 160. Figure 18C The protrusion 120 of the outer portion 20 engages with the needle cap 22. Figure 18D The surface 184 of the protrusion 164 is separated from the corresponding surface 186 of the rigid needle guard 58. Figure 18E Furthermore, the syringe holder 24 is spaced apart from the plunger body 80 of the drive assembly 40. Figure 18F ).

[0141] Reference Figures 19A-19F As the outer portion 20 continues to move axially away from the lower housing 28 ( Figure 19B Furthermore, the locking protrusion 112 is only partially received within the locking recess 114, the flange 176 of the retainer 160 is spaced apart from the outer portion 20, and the retaining tab 166 remains spaced apart from the body 162 of the retainer 160. Figure 19C ), the protrusion 120 of the outer part 20 and the needle cap 22 ( Figure 19D The surface 184 of the removed protrusion 164 is spaced apart from the corresponding surface 186 of the rigid needle guard 58. Figure 19E ), and the syringe holder 24 engages with the plunger body 80 of the drive assembly 40. Figure 19F ).

[0142] Reference Figure 20A-20F As the outer portion 20 continues to move axially away from the lower housing 28 ( Figure 20B Furthermore, the locking protrusion 112 separates from the locking recess 114, the flange 176 of the retainer 160 is further spaced apart from the outer portion 20, and the retaining tab 166 engages with the body 162 of the retainer 160. Figure 20C This causes the outer portion 20 and the retainer 160 to move axially away from the lower housing 28, disengaging the protrusion 120 of the outer portion 20 from the needle cap 22. Figure 20D ) and remove from the cap opening 122, removing the surface 184 of the protrusion 164 spaced apart from the corresponding surface 186 of the rigid needle guard 58. Figure 20E ), and the syringe holder 24 engages with the plunger body 80 of the drive assembly 40. Figure 20F ).

[0143] Reference Figure 21A-21F As the outer portion 20 continues to move axially away from the lower housing 28 ( Figure 21B The flange 176 of the retainer 160 is spaced apart from the outer portion 20 and the retaining tab 166 engages with the body 162 of the retainer 160. Figure 21C This causes the outer portion 20 and the retainer 160 to move axially away from the lower housing 28, and the protrusion 120 of the outer portion 20 continues to disengage from the needle cap 22. Figure 21D Remove the surface 184 of the protrusion 164 and engage the corresponding surface 186 of the rigid needle guard 58. Figure 21E ), and the syringe holder 24 engages with the plunger body 80 of the drive assembly 40. Figure 21F ).

[0144] Reference Figures 22A-22F As the outer portion 20 continues to move axially away from the lower housing 28 and separates from the lower housing 28 ( Figure 22B The flange 176 of the retainer 160 is spaced apart from the outer portion 20 and the retaining tab 166 engages with the body 162 of the retainer 160. Figure 22C This causes the outer portion 20 and the retainer 160 to move axially away from the lower housing 28, and the protrusion 120 of the outer portion 20 continues to disengage from the needle cap 22. Figure 22D The surface 184 of the removed protrusion 164 continues to engage with the corresponding surface 186 of the rigid needle guard 58, causing the rigid needle guard 58 to be axially displaced relative to the syringe barrel 52 of the syringe assembly 16. Figure 22E ), and the syringe holder 24 engages with the plunger body 80 of the drive assembly 40. Figure 22F ).

[0145] Reference Figure 23After the outer portion 20 is completely removed from the lower housing 28, the rigid needle guard 58 remains engaged with the retainer 160, but the rigid needle guard 58 is completely separated from the syringe barrel 552 of the syringe assembly 16.

[0146] Refer again Figure 17A-24 As described above, the outer portion 20 and the retainer 160 are configured to minimize the force required to remove them from the device 10 by separating the components sequentially rather than simultaneously. By sequentially removing the outer portion 20 from the lower housing 28, separating the protrusion 120 of the outer portion 20 from the needle cap 22, and removing the rigid needle shield 58 from the syringe assembly 16, the patient only needs to apply sufficient force for each step in the sequence, rather than the greater force required to remove these components simultaneously. This sequence is provided, as described above, by relative movement between the outer portion 20 and the retainer 160, relative movement between the outer portion 20 and the needle cap 22, and relative movement between the retainer 160 and the rigid needle shield 58.

[0147] Reference Figure 25-49 This illustrates a drug delivery device 300 according to another aspect of the invention. The drug delivery device 300 is similar to... Figure 1A-24 The drug delivery device 10 shown below has some differences discussed in detail below. Among other components, the drug delivery device 300 includes a motor body 302, a plunger body 304, a plunger rod portion 306, a lever actuation member 308, a syringe holder 310, a needle cap 312, a housing 314, a cap 316, a retainer 318, an upper housing 320, and a lower housing 322.

[0148] Reference Figure 24-28 Motor body 302 and Figure 1A-24The motor body 42 is similar in appearance and function to the motor body 302, but also includes a longitudinal groove 324, reinforcing ribs (or multiple reinforcing ribs) 326, and a clamp (or multiple clamps) 328. The longitudinal groove 324 is configured to receive the molded parting line of the plunger body 304 to ensure smooth sliding between the motor body 302 and the plunger body 304. The reinforcing ribs (or multiple reinforcing ribs) 326 provide additional support for a pair of arms 260 of the motor body 302. The clamps (or multiple clamps) 328 are received by an opening (or multiple openings) 330 defined by a housing 314 to secure the motor body 302 to the housing 314, which will be discussed in more detail below. The box clip (or multiple box clips) 328 includes an inclined surface 332 and a flat surface 334, the flat surface being configured to allow the box clip (or multiple box clips) 328 to be inserted into the opening (or multiple openings) 330 of the box body 314, but to prevent easy removal of the box clip (or multiple box clips) 328 once inserted into the opening (or multiple openings) 330 of the box body 314. The bottom surface 336 of the motor body 302 includes a chamfered portion 338 to aid in the assembly of the device 300.

[0149] Reference Figure 26 and Figure 29-32 The plunger body 304 is formed separately from, rather than integrally with, the plunger rod portion 306. Furthermore, the device 300 does not include a plunger rod cap 92. The plunger body 304 defines an opening 340 for receiving a plunger rod clamp 342 of the plunger rod portion 306. The plunger rod clamp 342 is barbed and configured to insert into the opening 340 of the plunger body 304 but not easily removed from it; however, other suitable shapes and configurations may also be used. The plunger rod clamp 342 defines a central opening 344 that allows the plunger rod clamp 342 to compress when inserted into the opening 340 of the plunger body 304 and to expand to its original shape once received within the plunger body 304. The plunger rod portion 306 includes a plunger body stop (or multiple plunger body stops) 346 and a biasing member 348. A plunger body stop (or multiple plunger body stops) 346, which may be one or more protruding portions, contacts the plunger body 304 when the plunger rod clamp 342 is inserted into the opening 340 of the plunger body 304. A biasing member 348 engages the plunger body 304 and biases the plunger rod portion 306 toward the plunger body 304 during the insertion of the plunger rod clamp 342 into the opening 340 of the plunger body 304. The biasing member 348 provides additional leeway for inserting the plunger rod clamp 342 into the opening 340 of the plunger body 304 while ensuring that there is no gap between the plunger body 304 and the plunger rod portion 306 after assembly. The biasing member 348 of the plunger rod portion 306 is annular, but other suitable shapes and configurations may also be used.

[0150] The plunger rod portion 306 also includes a plug interface 350 received by the plug 54. The plug interface 350 is a cross-shaped extension, but other suitable shapes and configurations may also be used. The plunger rod portion 306 has a conical outer shape configured to reduce stress on the syringe assembly 16, but other suitable shapes may also be used. The plunger body 304 includes a lever rib 352 extending into a lever opening 88 of the plunger body 304. The lever rib 352 is configured to be received by a lever actuation member 308, as discussed in more detail below.

[0151] Reference Figure 33 and 34 The lever actuating component 308 is the same as the above-mentioned... Figure 1A-24 The lever actuation member 44 shown is similar in appearance and function. However, the lever actuation member 308 defines a groove 354 at the axis of rotation 70, which receives the lever rib 352 of the plunger body 304. The engagement between the groove 354 and the lever rib 352 prevents relative lateral movement between the plunger body 304 and the lever actuation member 308. The needle cap contact surface 142 of the lever actuation member 308 includes a... Figure 1A-24 The needle cap contact surface 142 of the lever actuation component 44 is larger than the surface.

[0152] Reference Figure 35 and 36 Syringe holder 310 and Figure 1A-24 The syringe holder 24 is similar in appearance and function. However, the syringe holder 310 also includes a plurality of ribs 356 extending circumferentially around the syringe holder 310. These ribs engage springs 68. The retaining ring 220 of the syringe holder 310 also includes a plurality of radially inwardly extending protrusions 358. The protrusions 358 engage the syringe assembly 16 to eliminate any gaps between the outer surface of the syringe assembly 16 and the syringe holder 310. The protrusions 358 are resilient and compressible when the syringe assembly 16 is received within the syringe holder 310.

[0153] Reference Figure 37 and 38 , needle cap 312 and Figure 1A-24 The needle cap 22 is similar in appearance and function. The needle cap 312 includes a spring rib 360 that engages a spring 68 to hold the spring 68 between the needle cap 312 and the syringe holder 310. The needle cap 312 also includes a housing rib (or multiple housing ribs) 362 to guide movement of the needle cap 312 relative to the housing 314.

[0154] Reference Figure 39 , 40 48 and 49, box 314 and Figure 1A-24The housing 26 is similar in appearance and function. As described above, the housing 314 includes an opening (or multiple openings) 330 for receiving a clamp (or multiple clamps) 328 of the motor body 302. The housing 314 includes a needle cap clamp (or multiple needle cap clamps) 364 that engages a clamping surface (or multiple clamping surfaces) 366 of the needle cap 312. The clamping surface (or multiple clamping surfaces) 366 of the needle cap 312 is planar, but other suitable shapes and configurations may also be used. The needle cap clamp (or multiple needle cap clamps) 364 is configured to restrict axial movement of the needle cap 312 relative to the housing 314. The housing 314 also includes a motor body rib (or multiple motor body ribs) 368 and an outer housing rib (or multiple outer housing ribs) 370, which are configured to engage corresponding portions of the motor body 302 and the outer housing 320 to aid in the assembly of the device 300. The housing 314 also includes syringe retainer stops (or multiple syringe retainer stops) 372, which are configured to engage multiple portions of the syringe retainer 310 to restrict axial movement of the syringe retainer 310 relative to the housing 314. Although Figure 48 It is not shown in the diagram, but the locking clip 64 can also be used with the drug delivery device 300.

[0155] Reference Figures 41-46 Hat 316 and the above are in Figure 1A-24 The caps 18 shown are similar and functionally similar. The cap 316 includes a protrusion (or protrusions) 374 received by a cap opening (or multiple cap openings) 376 defined by the pin cap 312, the protrusions being positioned relative to... Figure 1A-24 The elements of the cap 18 are positioned at 90 degrees. The protrusions (or protrusions) 374 of the cap 316 are configured to engage the needle cap 312 when it is moved from its pre-use position to its actuated position. For example, when the device 300 is in its storage position and the cap 316 is secured to the lower housing 322, if the device is dropped or impacted, applying force to the needle cap 312, the lever actuation member 308, and / or other components, the protrusions (or protrusions) 374 restrict movement of the needle cap 312, preventing any accidental actuation of the device 300. The cap 316 also includes retainer clips (or retainer clips) 378 and ribs (or ribs) 380 for engaging the wing (or wing) 382 of the retainer 318. The retainer clips (or retainer clips) 378 and ribs (or ribs) 380 secure the retainer 318 to the cap 316 and prevent any movement or wobbling of the retainer 318 relative to the cap 316. The retainer 318 is configured to remove the rigid pin guard 58 when the cap 316 is removed from the lower housing 322. The cap 316 includes a lower housing clip (or multiple lower housing clips) 384 for engaging the lower housing 322 to secure the cap 316 to the lower housing 322. The upper housing 320 and the lower housing 322 are as discussed above and in... Figure 1A-24 The upper housing 46 and lower housing 28 shown are similar and functionally similar. However, the lower housing 322 has a cap interface 386 to receive a lower housing clip (or multiple lower housing clips) 384 for a cap 316.

[0156] Reference Figure 47 The drug delivery device 300 is shown in the injection position. The injection depth of the cannula 56 is determined by the contact between the syringe holder 310 and the housing 314 at point X and the contact between the needle cap 312 and the syringe holder 310 at point Y.

[0157] Reference Figure 47 The drug delivery device 300 includes a sound indicator component 388, which is related to the above-mentioned... Figure 1A-24 The sound indicator component 94 shown is similar in appearance and function. In the same manner as the sound indicator component 94 described above, the sound indicator component 388 of the drug delivery device 300 is configured to provide an audible indication to the user when the device 300 is switched to the post-use position. The sound indicator component 388 is configured to engage the ribs (or ribs) 390 of the housing 314 when the device 300 is in the injection position, thereby deflecting the sound indicator component 388. The sound indicator component 388 disengages from the ribs (or ribs) 390 of the housing 314, and when the drug delivery device 300 is switched from the injection position to the post-use position, the sound indicator component contacts the lower housing 322 of the outer casing to provide an audible click. However, the distal ends 392 of the ribs (or ribs) 390 of the housing 314 are tilted rearward toward the upper housing 320, engaging with... Figure 1A-24 Compared to the configuration of the ribs (or multiple ribs) 96 of the housing 26 discussed above, this advantageously provides a louder click.

[0158] In one aspect or embodiment, the distal end 392 of the rib (or ribs) 390 of the housing 314 has an angle Z greater than 5 degrees relative to a plane extending perpendicular to the longitudinal axis of the device 300. In one aspect or embodiment, the angle Z of the distal end 392 of the rib (or ribs) 390 is greater than 10 degrees. In one aspect or embodiment, the angle Z of the distal end 392 is 25 degrees.

[0159] Elements of a disclosed aspect may be combined with elements of one or more other disclosed aspects to form different combinations, all of which are considered to fall within the scope of the invention.

[0160] While this disclosure has been described as having an exemplary design, it can be further modified within the spirit and scope of this disclosure. Therefore, this application is intended to cover any variations, uses, or changes of this disclosure using its general principles. Furthermore, this application is intended to cover deviations from known or conventional practice falling within the scope of this disclosure and the limitations of the appended claims.

Claims

1. A drug delivery device (10), comprising: Casing (320, 322); A syringe assembly (16) includes a syringe barrel (52), a stopper (54), a cannula (56), and a rigid needle guard (58), the rigid needle guard receiving at least a portion of the cannula (56), and at least a portion of the syringe assembly (16) being positioned within the housing (320, 322). A drive assembly (40) configured to move the plug (54) within the syringe (52) when the drive assembly (40) is actuated, at least a portion of the drive assembly (40) being located within the housing (320, 322); A cap (316) is attached to the housing (320, 322), the cap (316) including an outer portion defining an interior space and one or more ribs (380), clips (378) and one or more protrusions (374) extending radially inward into the interior space. A retainer (318), the retainer being at least partially received within the cap (316), and the retainer comprising a body (162) having a pair of wings (382) extending radially outward from the body (162), the retainer (318) further comprising a removal protrusion (164) configured to remove the rigid needle guard (58) as the cap (316) moves axially away from the housing (320, 322); and A needle cap (312) has a pre-use position, an actuated position, and a post-use position. In the pre-use position, the cannula (56) is positioned within the needle cap (312). In the actuated position, the drive assembly (40) is actuated. In the post-use position, the cannula (56) is positioned within the needle cap (312). A cap (316) receives a portion of the needle cap (312) and is configured to prevent the needle cap (312) from moving from the pre-use position to the actuated position. The main body (162) of the retainer (318) includes a first end (178) and a second end (180) positioned opposite to the first end. The removal extension (164) extends radially inward from the main body (162) of the retainer (318) via a removal arm (182), which extends radially inward and in a direction from the second end (180) of the main body (162) to the first end (178) of the main body (162).

2. The drug delivery device (10) according to claim 1, wherein, One or more of the wings (382) are configured to engage with one or more of the one or more ribs (380) or clips (378) to secure the retainer (318) to the cap (316).

3. The drug delivery device (10) according to claim 1 or 2, wherein, The needle cap (312) includes one or more cap openings (376) configured to receive the one or more protrusions (374) of the cap (316).

4. The drug delivery device (10) according to claim 3, wherein, The interaction of the one or more protrusions (374) restricts the movement of the needle cap (312), thereby preventing the drug delivery device (10) from being accidentally actuated.

5. The drug delivery device (10) according to claim 1 or 2, wherein, The cap (316) also includes one or more clips (384) configured to secure the cap (316) to the housing (322).

6. The drug delivery device (10) according to claim 5, wherein, The housing (322) includes a cap interface (386) disposed at the distal end of the housing and configured to receive the cap (316) by one or more clips (384).

7. The drug delivery device (10) according to claim 1 or 2, wherein, The surface (184) of the removal protrusion (164) is configured to engage the corresponding surface (186) of the rigid needle guard (58) to remove the rigid needle guard (58) as the cap (316) moves axially away from the housing (320, 322), and the surface (184) of the removal protrusion (164) disengages from the corresponding surface (186) of the rigid needle guard (58) when the cap (316) is fixed to the housing (320, 322).

8. The drug delivery device (10) according to claim 7, wherein, The surface (184) of the removed protrusion (164) is planar, and the corresponding surface (186) of the rigid needle guard (58) is planar.

9. The drug delivery device (10) according to claim 7, wherein, The cap (316) includes a protrusion (120) received by a cap opening (122) defined by the needle cap (312), the protrusion (120) of the cap (316) being configured to engage the needle cap (312) when the needle cap (312) is moved from the pre-use position to the actuated position.

10. The drug delivery device (10) according to claim 9, wherein, The protrusion (120) is configured to be removed from the cap opening (122) before the surface (184) of the removed protrusion (164) engages the corresponding surface (186) of the rigid needle guard (58) as the cap (316) moves axially away from the outer shell (320, 322).

11. The drug delivery device (10) according to claim 1, wherein, The removal extension (164) is movable relative to the body (162) of the retainer (318) via the removal arm (182).

12. The drug delivery device (10) according to claim 1 or 2 further includes a syringe holder (24) positioned within the housing (320, 322), the syringe holder (24) receiving the syringe assembly (16), the syringe holder (24) being movable relative to the housing (320, 322), wherein, When the cap (316) is secured to the housing (320, 322), the syringe holder (24) disengages from the drive assembly (40), and wherein the syringe holder (24) engages with the drive assembly (40) as the cap (316) moves axially away from the housing (320, 322).

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