Auto-injector with locking clip

Abstract

A drug delivery device includes a first sub-assembly having a cap, a needle cover, a syringe holder configured to receive a syringe assembly, a cartridge body, and a lower housing case, the cap receiving at least a portion of the needle cover; a second sub-assembly including a drive assembly and a booster body, the drive assembly configured to move a stopper of the syringe assembly, wherein the booster body receives at least a portion of the drive assembly, the cartridge body of the first sub-assembly configured to receive at least a portion of the booster body; a locking clip configured to secure the first sub-assembly to the second sub-assembly when the first sub-assembly is assembled onto the second sub-assembly.

Description

[0001] This divisional application is based on Chinese Invention Patent Application No. 202080016879.2 (International Application No. PCT / EP2020 / 055005), entitled "Automatic Injector with Locking Clip", filed on February 26, 2020. Technical Field

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

[0003] Various types of automated injection devices have been developed to allow drug solutions and other liquid therapeutic preparations to be administered or self-injected by untrained personnel. Typically, these devices include a container 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 (e.g., autoinjectors) are designed such that the container (e.g., a pre-filled syringe) is assembled into the device during the device assembly process. 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 first sub-assembly, a second sub-assembly, and a locking clip. The first sub-assembly includes a cap, a needle cover, a syringe holder configured to receive a syringe assembly, a cartridge body, and a lower housing. The cap receives at least a portion of the needle cover. The second sub-assembly includes a drive assembly and a booster body. The drive assembly is configured to move a stopper of the syringe assembly. The booster body receives at least a portion of the drive assembly. The cartridge body of the first sub-assembly is configured to receive at least a portion of the booster body. The locking clip is configured to secure the first sub-assembly to the second sub-assembly when the first sub-assembly is assembled onto the second sub-assembly.

[0005] The drug delivery device may also include a syringe assembly comprising a barrel, a stopper, a cannula, and a rigid needle shield for receiving at least a portion of the cannula.

[0006] The locking clip may include a body having a protrusion configured to engage a clip surface defined by the booster body of the second subassembly. A housing body may define a clip opening configured to receive a portion of the locking clip. The locking clip may be C-shaped. The clip surface of the booster body may be defined by a recessed portion of the booster body, wherein, when the first subassembly is assembled with the second subassembly, the clip opening of the housing body is configured to align with the clip surface of the booster body, a portion of the locking clip is configured to extend through the clip opening and the recessed portion of the booster body, and the protrusion of the locking clip engages the clip surface of the booster body. The housing body may define a first recess and a second recess, and the booster body defines a first rib and a second rib; the first recess of the housing body is configured to receive the first rib of the booster body, and the second recess of the housing body is configured to receive the second rib of the booster body.

[0007] The locking clip may be integrally formed with the box body. The booster body may define a clip surface configured to engage the locking clip of the box body. The device may further include an upper outer shell configured to be positioned adjacent to a lower outer shell, the upper outer shell being configured to prevent the locking clip from disengaging from the clip surface when the upper outer shell is engaged with the lower outer shell. The booster body may include a first extension defining a first channel, and the box body may define a second extension defining a second channel, the first channel of the booster body being configured to receive the second extension of the box body. The second channel of the box body may be configured to receive the first extension of the booster body. The locking clip may include a first locking clip located on a first side of the box body and a second locking clip located on a second side of the box body.

[0008] In another aspect, a method of assembling a drug delivery device includes: moving a first sub-assembly to engage with a second sub-assembly, wherein the first sub-assembly includes a cap, a needle cover, a syringe holder configured to receive a syringe assembly, a cartridge body, and a lower outer housing, and the second sub-assembly includes a drive assembly and a booster body, the drive assembly being configured to move the plug of the syringe assembly; securing the first sub-assembly to the second sub-assembly with a locking clip; and moving an upper outer housing to engage with the second sub-assembly.

[0009] The method may further include positioning the syringe assembly in a syringe holder of a first sub-assembly, the syringe assembly including a barrel, a stopper, a cannula, and a rigid needle shield for receiving at least a portion of the cannula.

[0010] The method may further include inserting a portion of the locking clip through the clip opening of the box body and engaging the clip surface of the booster body to secure the box body to the booster body.

[0011] The method may further include: positioning the booster body within the housing body until the locking clip of the housing body engages the clip surface of the booster body, thereby securing the first sub-assembly to the second sub-assembly. Moving the upper outer housing to engage with the lower outer housing prevents the locking clip from disengaging from the clip surface.

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

[0013] - The drug delivery device may include: a first sub-assembly, a second sub-assembly, and a locking clip. The first sub-assembly includes a cap, a needle cover, a syringe holder configured to receive a syringe assembly, a cartridge body, and a lower housing. The cap receives at least a portion of the needle cover. The second sub-assembly includes a drive assembly and a booster body. The drive assembly is configured to move a stopper of the syringe assembly. The booster body receives at least a portion of the drive assembly. The cartridge body of the first sub-assembly is configured to receive at least a portion of the booster body. The locking clip is configured to secure the first sub-assembly to the second sub-assembly when the first sub-assembly is assembled onto the second sub-assembly.

[0014] - The drug delivery device may include a syringe assembly comprising a barrel, a stopper, a cannula, and a rigid needle shield for receiving at least a portion of the cannula;

[0015] - The locking clip may include a body having a protrusion configured to engage a clip surface defined by the booster body of the second sub-assembly;

[0016] - The box body may define a clip opening, which is configured to receive part of a locking clip;

[0017] - The locking clip can be C-shaped;

[0018] - The clip surface may be defined by a recessed portion of the booster body, the clip opening of the box body is configured to align with the clip surface of the booster body when the first sub-assembly is assembled with the second sub-assembly, and a portion of the locking clip is configured to extend through the clip opening of the box body and the recessed portion of the booster body, wherein a protrusion of the locking clip engages the clip surface of the booster body.

[0019] - The box body may define a first groove and a second groove, and the booster body defines a first rib and a second rib. The first groove of the box body is configured to receive the first rib of the booster body, and the second groove of the box body is configured to receive the second rib of the booster body.

[0020] -The locking clip is integrally formed with the main body of the box;

[0021] - The locking clip may include a first locking clip located on a first side of the box body and a second locking clip located on a second side of the box body;

[0022] - The booster body may define a clamp surface that is configured to engage one or more locking clamps of the box body;

[0023] -The upper outer casing can be configured to be positioned adjacent to the lower outer casing;

[0024] - The booster body may include a first extension defining a first channel, a box body defining a second extension, the second extension defining a second channel, and the first channel of the booster body being configured to receive the second extension of the box body;

[0025] - The second channel of the box body can be configured to receive the first extension of the booster body.

[0026] Another aspect of the present invention relates to a method of assembling a drug delivery device, comprising: moving a first sub-assembly to engage with a second sub-assembly, the first sub-assembly including a cap, a needle cover, a syringe holder configured to receive a syringe assembly, a cartridge body, and a lower outer housing, the second sub-assembly including a drive assembly and a booster body, the drive assembly being configured to move the plug of the syringe assembly; securing the first sub-assembly to the second sub-assembly with a locking clip; and moving an upper outer housing to engage with the second sub-assembly.

[0027] The method may also include one or more of the following features, individually or in combination depending on the technology:

[0028] - The method may include positioning a syringe assembly in a syringe holder of a first sub-assembly, the syringe assembly including a barrel, a stopper, a cannula, and a rigid needle shield for receiving at least a portion of the cannula;

[0029] - The locking clip may include a body having a protrusion, and a booster body defining a clip surface, wherein a box body defines a clip opening configured to receive a portion of the locking clip, the method further comprising: inserting a portion of the locking clip through the clip opening of the box body and engaging the clip surface of the booster body to secure the box body to the booster body.

[0030] - The locking clip can be integrally formed with the box body, wherein the booster body defines the clip surface, and the method further includes: positioning the booster body within the box body until the locking clip of the box body engages the clip surface of the booster body, thereby securing the first sub-assembly to the second sub-assembly. Attached Figure Description

[0031] The above and other features and advantages of this disclosure, as well as the ways in which they are implemented, will become more apparent from the following description of embodiments of this disclosure 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 Figure 1 is a perspective view of the drug delivery device, 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 Figure 1 is a perspective view of the drug delivery device, 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 cartridge body.

[0045] Figure 11B yes Figure 11A An enlarged cross-sectional view of the area 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 13 This is a bottom perspective view of the main body of the drug delivery device in Figure 1.

[0048] Figure 14 This is a top perspective view of the locking clip of the drug delivery device in Figure 1.

[0049] Figure 15 This is a perspective view of the booster body and locking clip of the drug delivery device shown in Figure 1.

[0050] Figure 16 This is a bottom perspective view of the box body and booster body according to another aspect of this application.

[0051] Figure 17 yes Figure 16 A three-dimensional view of the main body of the box.

[0052] Figure 18 This is a partial side view of a drug delivery device according to another aspect of this application, showing... Figure 16 The main body of the box and the main body of the booster.

[0053] Figure 19 yes Figure 16 Partial 3D view of the main body of the box and the main body of the booster.

[0054] Figure 20 yes Figure 18 A partial perspective view of a drug delivery device.

[0055] Figure 21 This is a perspective view of a drug delivery device according to another aspect of this application, showing the storage location of the device.

[0056] Figure 22 It is along Figure 21 The sectional view shown is taken by line 22-22.

[0057] Figure 23 yes Figure 21 Top perspective view of the booster body of the drug delivery device.

[0058] Figure 24 yes Figure 23 A three-dimensional view of the bottom of the booster body.

[0059] Figure 25 yes Figure 21 A three-dimensional view of the front of the plunger body of a drug delivery device.

[0060] Figure 26 yes Figure 25 A three-dimensional view of the rear of the plunger body.

[0061] Figure 27 yes Figure 21 A perspective view of the front part of the plunger rod section of a drug delivery device.

[0062] Figure 28 yes Figure 27 A three-dimensional view of the rear of the plunger rod section.

[0063] Figure 29 yes Figure 21 Top perspective view of the lever actuation component of the drug delivery device.

[0064] Figure 30 yes Figure 29 A three-dimensional view of the bottom of the lever actuation component of the drug delivery device.

[0065] Figure 31 yes Figure 21 A perspective view of the front of the syringe holder of a drug delivery device.

[0066] Figure 32 yes Figure 31 A perspective view of the rear of the syringe holder of a drug delivery device.

[0067] Figure 33 yes Figure 21 A three-dimensional view of the front part of the needle cover of a drug delivery device.

[0068] Figure 34 yes Figure 33 A three-dimensional view of the rear of the needle cover of a drug delivery device.

[0069] Figure 35 yes Figure 21 Top perspective view of the main body of the drug delivery device.

[0070] Figure 36 yes Figure 35 A perspective view of the bottom of the main body of the drug delivery device.

[0071] Figure 37 yes Figure 21 A three-dimensional view of the top of the cap of a drug delivery device.

[0072] Figure 38 It is along Figure 37 A sectional view taken along the center line 38-38.

[0073] Figure 39 yes Figure 21 A three-dimensional view of the retainer of a drug delivery device.

[0074] Figure 40 yes Figure 21 A cross-sectional view of the upper outer casing of the drug delivery device.

[0075] Figure 41 yes Figure 21 A perspective view of the lower outer casing of a drug delivery device.

[0076] Figure 42 It is along Figure 41 The sectional view taken from line 42-42.

[0077] Figure 43 yes Figure 21 A cross-sectional view of a drug delivery device, showing the injection site of the device.

[0078] Figure 44 yes Figure 21 A partial cross-sectional view of a drug delivery system.

[0079] Figure 45 yes Figure 21 A cross-sectional view of a drug delivery system.

[0080] In the various views, corresponding reference numerals denote corresponding parts. The examples set forth 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

[0081] The following description is provided to enable those skilled in the art to make and use the described embodiments to practice the invention. However, various modifications, equivalents, variations, and substitutions will be readily 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.

[0082] For the purposes of the following description, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the invention as oriented as shown in the accompanying drawings. However, it should be understood that various alternative variations may be taken in the invention unless explicitly stated to the contrary. 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.

[0083] refer to Figure 1A-10According 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 cover 22, a syringe holder 24, a cartridge body 26, and a lower outer housing 28. The second sub-assembly 14 includes a drive assembly 40, a booster body 42, a lever actuation member 44, and an upper outer housing 46. The syringe assembly 16 is received by the syringe holder 24 and includes a barrel 52, a stopper 54, a cannula 56, and a rigid needle shield (RNS) 58. The lower outer housing 28, the cartridge body 26, and the upper outer housing 46 generally form a housing for receiving various components of the device 10, but other suitable housing arrangements 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 a locking clip 64, but other suitable arrangements may also be used. The drug delivery device 10 may be an autoinjector, but the features described herein can be incorporated into other suitable drug delivery devices.

[0084] The drug delivery device 10 is configured to automatically deliver a dose of medication from the syringe assembly 16 to the 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 such that the cannula 56 punctures the patient's skin, and displacing the stopper 54 within the barrel 52 of the syringe assembly 16 to deliver medication within the 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 8As discussed in more detail below, the needle cover 22 is configured to shield the cannula 56 of the syringe assembly 16 from injury to the patient when the device 10 is in the pre-use and post-use positions. Specifically, the needle cover 22 is movable between the pre-use, actuated, and post-use positions, and a spring 68 biases the needle cover 22 toward the pre-use and post-use positions. The spring 68 is located between the needle cover 22 and the syringe holder 24, but other suitable arrangements may also be used. The lever actuation member 44 is movable between a locked position and a released position, in which the drive assembly 40 is prevented from moving and in the released position, the drive assembly 40 is allowed to move. 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, the lever actuation member 44 engages with the booster 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 booster body 42, thereby allowing the drive assembly 40 to move toward the syringe assembly 16. The axis of rotation 70 of the lever actuation member 44 extends perpendicular to the longitudinal axis of the device 10, but other suitable arrangements may also be used.

[0085] 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 booster, hydraulic pressure, other types of springs, etc. The drive member 84 engages the plunger body 80 and the booster body 42 and biases the plunger body 80 in a direction extending from the second subassembly 14 toward the first subassembly 12. The plunger body 80 defines a lever opening 88 for receiving a lever actuation member 44 and defines an axis of rotation 70 for the lever actuation member 44. When the lever actuation member 44 is in a locked position through engagement with the booster body 42, the lever actuation member 44 prevents movement of the plunger body 80. When the lever actuation member 44 rotates from the locked position to the released position, the lever actuation member 44 disengages from the booster body 42, thereby allowing the drive member 84 to move the plunger body 80 and the plunger rod portion 82 toward the first subassembly 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.

[0086] The drive assembly 40 also includes a spring guide member 90, which is fixed to the upper housing 46 and received within the drive opening 86 of the plunger body 80. A drive member 84 is received by the spring guide member 90 such that the drive member 84 is located between the plunger body 80 and the spring guide member 90. The drive assembly 40 also includes a plunger rod cover 92 that receives a plunger rod portion 82 of the plunger body 80. The plunger rod cover 92 is configured to guide the plunger rod portion 82 into the barrel 52 of the syringe assembly 16 and engage the stopper 54 of the syringe assembly 16 to dispense medication from the barrel 52 of the syringe assembly 16. The plunger rod cover 92 and the plunger rod portion 82 may be integrally formed or formed as separate components.

[0087] The plunger body 80 of the drive assembly 40 also includes an audio 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 audio indicator member 94 is configured to engage one or more ribs 96 of the cartridge body 26 when the device 10 is in the injection position, thereby deflecting the audio indicator member 94. When the drug delivery device 10 is switched from the injection position to the post-use position, the audio indicator member 94 disengages from one or more ribs 96 of the cartridge body 26 and contacts the lower housing 28 to provide an audible click; however, the audio indicator member 94 may also contact other suitable parts of the device 10 to provide an audible indication.

[0088] refer to Figure 1A-2B In the storage position, the cap 18 is secured to the lower outer housing 28 and engages with the needle cover 22. Movement of the needle cover 22 from the pre-use position to the actuated position causes engagement between the needle cover 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 cover 22 can be moved from the pre-use position to the actuated position by pressing the needle cover 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 cover 22 prevents the needle cover 22 from moving to engage with the lever actuation member 44. Therefore, removing the cap 18 from the device 10 allows actuation of the device 10. Figure 1B and 2B As shown, removing the cap 18 from the device 10 also removes the RNS 58 from the syringe barrel 52, thereby exposing the cannula 56, which was still received within the needle cover 22 in its pre-use position with the device 10. The cap 18 may include one or more components received within the outer portion 20 to facilitate the removal of the RNS 58.

[0089] Reference Figure 3 and Figure 4In the actuated position, the cap 18 is removed, and the needle cover 22 is positioned in the actuated position by engaging with the patient's skin surface, which allows the needle cover 22 to move further toward the second sub-assembly 14 within the device 10. When the needle cover 22 has moved a sufficient distance within the device 10, a portion of the needle cover 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.

[0090] refer to Figure 5 and 6 At 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 cover 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 retainer 24 to move relative to the cartridge body 26 within the device 10 until the syringe retainer 24 abuts against the stop 102 defined by the cartridge body 26. During this initial movement of the syringe assembly 16 and syringe retainer 24, the needle cover 22 presses against the patient's skin surface, and the cannula 56 of the syringe assembly 16 extends beyond the needle cover 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 barrel 52 of the syringe assembly 16 to dispense medication from the barrel 52 of the syringe assembly 16 through the cannula 56 and into the patient's body. The plunger body 80 continues to move until the stopper 54 is lowered to its lowest point on the barrel 52 of the syringe assembly 16. As the stopper 54 reaches its lowest point, the audio indicator member 94 disengages from one or more ribs 96 of the cartridge body 26 and contacts the lower housing 28 approximately simultaneously, providing the patient with an audible indication that a dose has been delivered. In addition to the audible indication, the drug delivery device 10 provides one or more visual indicators to notify the patient of the status of the device 10. Specifically, the cartridge body 26 may be formed of a transparent material to allow visual confirmation of the movement of the stopper 54 and / or 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 that provides a visual indication that the plunger body 80 is in its final position and a dose has been delivered. The visual indicators may use contrasting colors, symbols, patterns, or any other suitable visual markings to indicate various states of the device.

[0091] refer to Figure 7 , 8 11A, 11B, and 12, in the post-use position, when the needle cover 22 is removed from the patient's skin surface, the needle cover 22 extends to the post-use position to shield the cannula 56. (As shown) Figure 11BAs shown more clearly in the diagram, the cartridge body 26 includes a locking arm 106, and the needle cover 22 includes a locking protrusion 108, although other suitable configurations may also be used. The locking arm 106 of the cartridge body 26 engages the locking protrusion 108 of the needle cover 22 to prevent any further use of the device 10 and exposure of the cannula 56 of the syringe assembly 16. During the transition of the device 10 from the injection position to the post-use position, the locking arm 106 of the cartridge body 26 deflects to allow the locking protrusion 108 of the needle cover 22 to pass through the cartridge body 26, and the locking arm 106 returns to its original position to prevent the needle cover 22 from moving back toward the pre-use and actuated positions. In the pre-use position of the needle cover 22, a portion of the needle cover 22 engages the cover stop 110 of the syringe holder 24 to limit axial movement of the needle cover 22 in the direction extending from the second sub-assembly 14 toward the first sub-assembly 12. After use of device 10, syringe retainer 24 is displaced within housing 26 relative to needle cover 22, allowing needle cover 22 to extend to its post-use position when the patient removes it from the skin surface. Figure 12 As shown, when the needle cover 22 is removed from the patient's skin surface, the needle cover 22 will move to the post-use position regardless of the position of the stopper 54 within the barrel 52 of the syringe assembly 16. Therefore, if the patient removes the needle cover 22 from the skin surface after only a portion of the medication has been delivered, the needle cover 22 will still move to the post-use position and will prevent further use of the device 10.

[0092] refer to Figure 9 , 10 And 13-15, locking clip 64 is configured to secure the first sub-component 12 to the second sub-component 14 when the first sub-component 12 is assembled onto the second sub-component 14. For example Figure 9 As shown, the box body 26 is configured to receive at least a portion of the booster body 42. Although Figure 10 As not shown, the syringe assembly 16 is positioned within the syringe holder 24 before the first sub-assembly 12 is assembled to the second sub-assembly 14. Figure 14 As shown, the locking clip 64 includes a body 120 having at least one protrusion 122 configured to engage at least one clip surface 124 defined by the booster body 42 of the second subassembly 14. (Reference) Figure 15 The locking clip 64 includes two protrusions 122, and the booster body 42 includes two clip surfaces 124, but other suitable arrangements may also be used. Furthermore, as... Figure 13 As shown more clearly in the diagram, the box body 26 defines at least one clip opening 126, which is configured to receive part of a locking clip 64. Figure 13As shown, two clip openings 126 are provided, but other suitable arrangements may also be used. The locking clip 64 is C-shaped, but other suitable shapes and configurations may also be used. When the first sub-assembly 12 is assembled with the second sub-assembly 14, the clip openings 126 of the housing body 26 are configured to align with the clip surface 124 of the booster body 42. More specifically, in one aspect, the clip openings 126 are aligned with the clip surface 124 in a direction extending along the longitudinal axis of the device 10. A portion of the locking clip 64 is configured to extend through the clip openings 126, and a protrusion 122 of the locking clip 64 engages the clip surface 124 of the booster body 42. The housing body 26 defines a first recess 128 and a second recess 130, and the booster body 42 defines a first rib 132 and a second rib 134. The first groove 128 of the box body 26 is configured to receive the first rib 132 of the booster body 42, and the second groove 130 of the box body 26 is configured to receive the second rib 134 of the booster body 42.

[0093] Reference Figure 9 and 10 A method of assembling a drug delivery device 10 according to one aspect of this application includes: moving a first sub-assembly 12 to engage with a second sub-assembly 14; securing the first sub-assembly 12 to the second sub-assembly 14 with a locking clip 64; and moving an upper outer housing 46 to engage with a lower outer housing 28. The first sub-assembly 12 and the second sub-assembly 14 are axially aligned, the booster body 42 is located within a cartridge body 26, and the first sub-assembly 12 and the second sub-assembly 14 are moved toward each other until a first recess 128 and a second recess 130 of the cartridge body 26 receive a first rib 132 and a second rib 134 of the booster body 42. The first recess 128 and the second recess 130 of the cartridge body 26 guide the booster body 42 into the cartridge body 26. The booster body 42 and the cartridge body 26 are moved toward each other until a clip opening 126 of the cartridge body 26 aligns with a clip surface 124 of the booster body 42, which may occur when the booster body 42 contacts the lower outer housing 28 of the first sub-assembly 12. Although Figure 10 As not shown, before assembling the first sub-assembly 12 and the second sub-assembly 14, the syringe assembly 16 is positioned within the syringe holder 24. A portion of the body 120 of the locking clip 64 is inserted through the clip opening 126 of the cartridge body 26 until the protrusion 122 engages the clip surface 124 of the booster body 42, thereby securing the cartridge body 26 to the booster body 42 and securing the first sub-assembly 12 to the second sub-assembly 14.

[0094] Reference Figure 16-20According to another aspect of this application, the locking clip 140 is integrally formed with the box body 26 for securing the first sub-assembly 12 to the second sub-assembly 14, instead of providing a separate locking clip 64 as discussed above. More specifically, the box body 26 includes two locking clips 140 on each side of the box body 26, but one or more locking clips 140 may be provided. The locking clips 140 are configured to engage with the first sub-assembly 12 when it is assembled onto the second sub-assembly 14. Figure 9 and 10 The first sub-assembly 12 is secured to the second sub-assembly 14 in a similar manner to the locking clip 64. The side surface 142 of the booster body 42 defines a clip surface 124, which is configured to engage the locking clip 140 of the cartridge body 26; however, depending on the configuration of the locking clip 140, one or more clip surfaces 124 may be provided. When the booster body 42 is received by the cartridge body 26, the locking clip 140 (in...) Figure 17 (As shown more clearly in the image) are configured to deflect radially outward until the booster body 42 is fully inserted into the box body 26 and the locking clips 140 are aligned with the clip surface 124, thereby allowing the locking clips 140 to return to their initial unbiased position. Figure 20 As shown, the upper outer housing 46 is configured to prevent the locking clip 140 from disengaging from the clip surface 124 when the upper outer housing 46 is engaged with the lower outer housing 28. More specifically, when the upper outer housing 46 is positioned above the booster body 42 and engaged with the lower outer housing 28, the upper outer housing 46 prevents the locking clip 140 from radially deflecting outward, which prevents the locking clip 140 from disengaging from the clip surface 124 of the booster body 42. When positioned on the housing body 26 and the booster body 42, the upper outer housing 46 is positioned sufficiently close to the locking clip 140 to prevent such radial deflection and to engage the locking clip 140 during movement.

[0095] refer to Figure 18 and 19 The booster body 42 includes a first extension 144 defining a first channel 146, and the housing body 26 defines a second extension 148, which in turn defines a second channel 150. The first channel 146 of the booster body 42 is configured to receive the second extension 148 of the housing body 26. The second channel 150 of the housing body 26 is configured to receive the first extension 144 of the booster body 42. The booster body 42 includes two first extensions 144 and two first channels 146, and the housing body 26 includes two second extensions 148 and two second channels 150, but may provide one or more first extensions 144 and second extensions 148, and one or more first channels 146 and second channels 150.

[0096] refer to Figure 16The first sub-assembly 12 is secured to the second sub-assembly 14 by positioning the booster body 42 within the housing body 26 until the locking clip 140 of the housing body 26 engages the clip surface 124 of the booster body 42. As mentioned above, moving the upper outer housing 46 to engage with the lower outer housing 28 prevents the locking clip 140 from disengaging from the clip surface 124. The engagement between the first channel 146 and the second channel 150 with the first extension 144 and the second extension 148 respectively guides the insertion of the booster body 42 into the housing body 26.

[0097] Reference Figure 21-45 This illustrates a drug delivery device 300 according to another aspect of the present invention. The drug delivery device 300 is similar to... Figure 1A-20 The drug delivery device 10 shown below will be discussed in detail for some of its differences. Among other components, the drug delivery device 300 includes a booster body 302, a plunger body 304, a plunger rod portion 306, a lever actuation member 308, a syringe holder 310, a needle cover 312, a cartridge body 314, a cap 316, a retainer 318, an upper outer housing 320, and a lower outer housing 322.

[0098] refer to Figure 21-24 The booster body 302 is similar to Figure 1A-20 The booster body 42 functions in the same manner, but also includes longitudinal grooves 324, one or more reinforcing ribs 326, and one or more box clips 328. The longitudinal grooves 324 are configured to receive the molding split line of the plunger body 304 to ensure smooth sliding between the booster body 302 and the plunger body 304. The one or more reinforcing ribs 326 provide additional support for a pair of arms 260 of the booster body 302. The one or more box clips 328 are received by one or more openings 330 defined by the box body 314 to secure the booster body 302 to the box body 314, which will be discussed in more detail below. One or more box clips 328 include angled surfaces 332 and flat surfaces 334, configured to allow insertion of one or more box clips 328 into one or more openings 330 of the box body 314, but prevent easy removal of the box clips 328 once inserted into the openings 330 of the box body 314. The bottom surface 336 of the booster body 302 includes a chamfered portion 338 to aid in the assembly of the device 300.

[0099] refer to Figure 22 and 25-28. The plunger body 304 and the plunger rod portion 306 are formed separately, rather than integrally. Furthermore, the device 300 does not include a plunger rod cover 92. The plunger body 304 defines an opening 340 that receives a plunger rod clamp 342 from 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 is not easily removed from the opening 340; however, other suitable shapes and configurations can 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 expands to its original shape once the plunger rod clamp 342 is received in the plunger body 304. The plunger rod portion 306 includes one or more plunger body stops 346 and biasing members 348. When the plunger rod clamp 342 is inserted into the opening 340 of the plunger body 304, one or more plunger body stops 346 (which may be one or more protrusions) contact the plunger body 304. During the insertion of the plunger rod clamp 342 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. The biasing member 348 provides additional leeway for the plunger rod clamp 342 to insert 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.

[0100] The plunger rod portion 306 also includes a plug interface 350 received by the plug 54. The plug interface 350 is a cross-shaped protrusion, but other suitable shapes and configurations may also be used. The plunger rod portion 306 has a conical external 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.

[0101] refer to Figure 29 and 30 The lever actuation component 308 is similar to that described above and in Figure 1A-20 The lever actuation member 44 shown in the diagram functions in the same manner. 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. Figure 1A-20Compared to the needle cover contact surface 142 of the lever actuation member 44, the needle cover contact surface 142 of the lever actuation member 308 includes a larger surface area.

[0102] refer to Figure 31 and 32 The syringe retainer 310 is similar to Figure 1A-20 The syringe retainer 24 functions in a similar manner. However, the syringe retainer 310 also includes a plurality of ribs 356 extending circumferentially around the syringe retainer 310. These ribs engage springs 68. The retaining ring 220 of the syringe retainer 310 also includes a plurality of radially inwardly extending protrusions 358. These protrusions 358 engage the syringe assembly 16 to remove any gaps between the outer surface of the syringe assembly 16 and the syringe retainer 310. The protrusions 358 are elastomeric and compressible when the syringe assembly 16 is received within the syringe retainer 310.

[0103] refer to Figure 33 and 34 The needle cover 312 is similar to Figure 1A-20 The needle cover 22 functions in the same manner. The needle cover 312 includes a spring rib 360 that engages a spring 68 to hold the spring 68 between the needle cover 312 and the syringe holder 310. The needle cover 312 also includes one or more box ribs 362 to guide movement of the needle cover 312 relative to the box body 314.

[0104] refer to Figure 35 , 36 44 and 45, the main body of box 314 is similar Figure 1A-20The housing body 26 functions in the same manner. As discussed above, the housing body 314 includes one or more openings 330 for receiving one or more housing clips 328 of the booster body 302. The housing body 314 includes one or more needle cover clips 364 that engage one or more clip surfaces 366 of the needle cover 312. The clip surfaces 366 of the needle cover 312 are planar, but other suitable shapes and configurations may also be used. The one or more needle cover clips 364 are configured to restrict axial movement of the needle cover 312 relative to the housing body 314. The housing body 314 also includes one or more booster body ribs 368 and one or more upper housing ribs 370, which are configured to engage corresponding portions of the booster body 302 and the upper housing 320 to facilitate assembly of the device 300. The housing body 314 also includes one or more syringe retainer stops 372 configured to engage portions of the syringe retainer 310 to restrict axial movement of the syringe retainer 310 relative to the housing body 314. Although Figure 44 As not shown, the locking clip 64 can also be used with the drug delivery device 300.

[0105] refer to Figure 37-42 Hat 316 is similar to the above and Figure 1A-20 The cap 18 shown functions in the same manner. The cap 316 includes one or more protrusions 374, which are received by one or more cap openings 376 defined by the needle cover 312, relative to... Figure 1A-20The elements of the cap 18 are positioned at 90 degrees. One or more protrusions 374 of the cap 316 are configured to engage the needle cover 312 when it moves 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 to exert force on the needle cover 312, the lever actuation member 308, and / or other components, the protrusions 374 restrict movement of the needle cover 312, preventing any accidental actuation of the device 300. The cap 316 also includes one or more retainer clips 378 and one or more ribs 380 for engaging one or more wings 382 of the retainer 318. The retainer clips 378 and 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 RNS 58 when the cap 316 is removed from the lower housing 322. The cap 316 includes one or more 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 similar to those discussed above and Figure 1A-20 The upper outer casing 46 and lower outer casing 28 are shown and function in a similar manner. However, the lower outer casing 322 has a cap interface 386 to receive one or more lower outer casing clips 384 of the cap 316.

[0106] refer to Figure 43 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 cartridge body 314 at point X and the contact between the needle cover 312 and the syringe holder 310 at point Y.

[0107] refer to Figure 43 The drug delivery device 300 includes an audio indicator component 388, which is similar to that described above and... Figure 1A-20The audio indicator component 94 shown in the diagram functions in a similar manner. In the same manner as the audio indicator component 94 described above, the audio 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 audio indicator component 388 is configured to engage one or more ribs 390 of the cartridge body 314 when the device 300 is in the injection position, thereby deflecting the audio indicator component 388. When the drug delivery device 300 is switched from the injection position to the post-use position, the audio indicator component 388 disengages from one or more ribs 390 of the cartridge body 314 and contacts the lower outer housing 322 to provide an audible click. However, the distal ends 392 of the one or more ribs 390 of the cartridge body 314 are angled rearward toward the upper outer housing 320, engaging with the upper... Figure 1A-20 Compared to the arrangement of one or more ribs 96 in the body of the box 26 under discussion, this advantageously provides a greater audible click.

[0108] In one aspect or embodiment, the distal end 392 of one or more ribs 390 of the box body 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 one or more ribs 390 is greater than 10 degrees. In one aspect or embodiment, the angle Z of the distal end 392 is 25 degrees.

[0109] An element of one disclosed aspect may 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 invention.

[0110] While this disclosure is described as having an exemplary design, it may be further modified within the spirit and scope of this disclosure. Therefore, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover deviations from this disclosure that are within the scope of known or customary practice in the art to which this disclosure pertains and that fall within the limitations of the appended claims.

Claims

1. A liquid drug formulation delivery device (300), the liquid drug formulation delivery device comprising: A first sub-assembly (12) includes a cap (316), a needle cover (312), a syringe holder (310) configured to receive a syringe assembly (16), a cartridge body (314), and a lower outer shell (322), wherein the cap (316) has a retainer (318) and receives at least a portion of the needle cover (312); The second sub-assembly (14) includes a lever actuation member (308), a drive assembly (40) having a plunger body (304) and a plunger rod portion (306), and a booster body (302), the drive assembly being configured to move the plug (54) of the syringe assembly (16), the booster body (302) receiving at least a portion of the drive assembly (40), and the cartridge body (314) of the first sub-assembly (12) being configured to receive at least a portion of the booster body (302); and Upper outer casing (320) and lower outer casing (322); When the first sub-component (12) is assembled onto the second sub-component (14), the first sub-component (12) is fixed onto the second sub-component (14); The cap (316) includes: a protrusion (374) received by a cap opening (376), the protrusion (374) of the cap (316) being configured to engage the needle cover (312); a retainer clip (378) and a rib (380) for engaging the wing (382) of the retainer (318); and a lower outer shell clip (384) for engaging the lower outer shell (322) to secure the cap (316) to the lower outer shell (322).

2. The liquid drug formulation delivery device (300) according to claim 1, wherein, The booster body (302) also includes longitudinal grooves (324), reinforcing ribs (326) and box clips (328).

3. The liquid drug formulation delivery device (300) according to claim 2, wherein, The longitudinal groove is configured to receive the molded parting line of the plunger body (304) for sliding between the booster body (302) and the plunger body (304).

4. The liquid drug formulation delivery device (300) according to claim 2, wherein, The reinforcing rib (326) is configured to support a pair of arms (260) of the booster body (302).

5. The liquid drug formulation delivery device (300) according to claim 2, wherein, The box clip (328) is received by the opening (330) of the box body (314) to secure the booster body (302) to the box body (314).

6. The liquid drug formulation delivery device (300) according to claim 5, wherein, The box clip (328) includes an angled face (332) and a flat face (334), which are configured to insert the box clip (328) into an opening (330) of the box body (314).

7. The liquid drug delivery device (300) according to claim 1 further includes a bottom surface (336) of the booster body (302), the bottom surface (336) including a chamfered portion (338) configured for assembly of the liquid drug delivery device (300).

8. The liquid drug formulation delivery device (300) according to claim 1, wherein, The plunger body (304) is formed separately from the plunger rod portion (306).

9. The liquid drug formulation delivery device (300) according to claim 1, wherein, The plunger body (304) includes an opening (340) that receives a plunger rod clamp (342) from the plunger rod portion (306).

10. The liquid drug formulation delivery device (300) according to claim 9, wherein, The plunger rod clamp (342) is barbed and configured to compress and insert into the opening (340) of the plunger body (304), and the plunger rod clamp (342) includes a central opening (344) configured to allow the plunger rod clamp (342) to compress when inserted into the opening (340) of the plunger body (304).

11. The liquid drug formulation delivery device (300) according to claim 10, wherein, The plunger rod portion (306) includes a plunger body stop (346) and a biasing member (348), the plunger body stop being configured to contact the plunger body (304) when the plunger rod clamp (342) is inserted into the opening (340) of the plunger body, and the biasing member (348) being configured to engage the plunger body (304) during the insertion of the plunger rod clamp (342) into the opening (340) of the plunger body and bias the plunger rod portion (306) toward the plunger body (304).

12. The liquid drug formulation delivery device (300) according to claim 9, wherein, The plunger rod portion (306) also includes a plug interface (350).

13. The liquid drug formulation delivery device (300) according to claim 1, wherein, The lever actuation member (308) includes a groove (354) for receiving the lever rib (352) of the plunger body (304).

14. The liquid drug formulation delivery device (300) according to claim 1, wherein, The syringe holder (310) also includes a plurality of ribs (356) extending circumferentially around the syringe holder (310).

15. The liquid drug formulation delivery device (300) according to claim 1, wherein, The needle cover (312) includes a spring rib (360) that engages with a spring (68) between the needle cover (312) and the syringe holder (310).

16. The liquid drug formulation delivery device (300) according to claim 1, wherein, The needle cover (312) also includes a box rib (362) configured to guide the needle cover (312).

17. The liquid drug formulation delivery device (300) according to claim 2, wherein, The box body (314) includes: The opening (330) of the receiving box clip (328) is received. A needle cover clip (364) engages the clip surface (366) of the needle cover (312), wherein the clip surface (366) of the needle cover (312) is planar; Booster body rib (368) and upper outer shell rib (370), the booster body rib and the upper outer shell rib being configured to engage portions of the booster body (302) and the upper outer shell (320); and Syringe retainer stop (372), which is configured to engage a portion of the syringe retainer (310).

18. A liquid drug formulation delivery device (300), the liquid drug formulation delivery device comprising: A first sub-assembly (12) includes a cap (316), a needle cover (312), a syringe holder (310) configured to receive a syringe assembly (16), a cartridge body (314), and a lower outer shell (322), wherein the cap (316) has a retainer (318) and receives at least a portion of the needle cover (312); The second sub-assembly (14) includes a lever actuation member (308), a drive assembly (40), and a booster body (302). The drive assembly has a plunger body (304), a plunger rod portion (306), and an audio indicator member (388). The plunger body (304) is configured to move the plug (54) of the syringe assembly (16). The booster body (302) receives at least a portion of the drive assembly (40). The cartridge body (314) of the first sub-assembly (12) is configured to receive at least a portion of the booster body (302). When the first sub-component (12) is assembled onto the second sub-component (14), the first sub-component (12) is fixed onto the second sub-component (14), and the audio indicator component (388) is configured to provide an auditory indication for transitioning to the post-use position, wherein an audible click is generated when the liquid drug delivery device (300) transitions from the injection position to the post-use position; The cap (316) includes: a protrusion (374) received by a cap opening (376), the protrusion (374) of the cap (316) being configured to engage the needle cover (312); a retainer clip (378) and a rib (380) for engaging the wing (382) of the retainer (318); and a lower outer shell clip (384) for engaging the lower outer shell (322) to secure the cap (316) to the lower outer shell (322).

19. The liquid drug formulation delivery device (300) according to claim 18, wherein, The distal end (392) of the rib (390) of the box body (314) has an angle Z greater than 5 degrees relative to the plane extending perpendicular to the longitudinal axis of the liquid drug delivery device (300).

20. The liquid drug formulation delivery device (300) according to claim 19, wherein, The angle Z of the distal end (392) of the rib (390) is greater than 10 degrees.

21. The liquid drug formulation delivery device (300) according to claim 19, wherein, The angle Z of the distal end (392) of the rib (390) is 25 degrees.

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