Automatic injector with needle cover

Abstract

A drug delivery device comprising a housing, a syringe assembly including a barrel, a bung, and a cannula, at least a portion of the syringe assembly being positioned within the housing, a drive assembly configured to move the bung within the barrel when the drive assembly is actuated, wherein at least a portion of the drive assembly is positioned within the housing, a lever actuation member movable between a locked position which prevents actuation of the drive assembly and a released position which permits actuation of the drive assembly, and a needle cover having a pre-use position in which the cannula is positioned within the needle cover, an actuation position in which the needle cover is configured to actuate the drive assembly, and a post-use position in which the cannula is positioned within the needle cover. The needle cover is configured to engage the lever actuation member and move the lever actuation member to the released position when the needle cover is in the actuation position.

Description

[0001] This application is a divisional application of the invention patent application entitled "Automatic Injector with Needle Cap", with an international filing date of February 26, 2020, international application number PCT / EP2020 / 055003, and national application number 202080016833.0. 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 by untrained personnel or self-injected. 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 such that the reservoir (such as a pre-filled syringe) is assembled into the device during device assembly. In addition to the automated needle injection mechanism, many drug delivery devices also automatically shield the needle after the device has been used to prevent any unintended contact with the needle. Summary of the Invention

[0004] In one aspect, a drug delivery device includes a housing; a syringe assembly including a barrel, a stopper, and a cannula, wherein at least a portion of the syringe assembly is located within the housing; a drive assembly configured to move the stopper within the barrel when the drive assembly is actuated, wherein at least a portion of the drive assembly is located within the housing; a lever actuation member movable between a locked position preventing actuation of the drive assembly and a released position allowing actuation of the drive assembly; and a needle cap having a pre-use position, an actuated position, and a post-use position, wherein the cannula is located within the needle cap in the pre-use position, the drive assembly is actuated in the actuated position, and the cannula is located within the needle cap in the post-use position. The needle cap is configured to engage the lever actuation member and move the lever actuation member to the released position when the needle cap is in the actuated position.

[0005] The drug delivery device may further include a syringe holder movable relative to the housing between a first position and a second position, the syringe assembly being received by the syringe holder. The syringe holder is configured to move from the first position to the second position when the needle cap is in the actuated position, wherein when the syringe holder is in the second position and when the needle cap is in the actuated position, a portion of the cannula of the syringe assembly extends outside the needle cap. When the needle cap is in the pre-use position, a portion of the needle cap may engage a cap stop of the syringe holder to limit axial movement of the needle cap in at least one direction. The drive assembly may include a plunger body having a plunger rod portion and a drive member, wherein the drive member is configured to move the plunger body within the housing. The longitudinal axis of the plunger rod may be spaced apart from and parallel to the longitudinal axis of the drive member. The drive member may be a compression spring. The drive assembly may further include a plunger rod cap positioned over at least a portion of the plunger rod portion, wherein the plunger rod cap is configured to engage a plug of the syringe assembly. The drive assembly may further include a spring guide member, wherein the drive assembly is positioned on the spring guide member.

[0006] When the needle cap is in the pre-use position, the needle cap can prevent the lever actuation member from moving from the locked position to the released position.

[0007] The lever actuation member is rotatable about a rotation axis between a locked position and a released position. The lever actuation member may include a limiting surface configured to engage the needle cap and limit rotation of the lever actuation member when the needle cap is in the pre-use position. When the needle cap is in the pre-use position, the limiting surface of the lever actuation member may be spaced apart from the needle cap to form a gap. The needle cap may include a lever contact portion, and the lever actuation member may include a needle cap contact surface, wherein the lever contact portion of the needle cap is configured to engage the needle cap contact surface of the lever actuation member, and when the needle cap is in the actuated position, cause the lever actuation member to rotate about the rotation axis from the locked position to the released position. The lever actuation member may define a recessed region configured to receive a portion of the lever contact portion of the needle cap when the needle cap is in the actuated position. The lever contact portion of the needle cap may define a cylindrical surface, and the needle cap contact surface of the lever actuation member may define a flat surface.

[0008] The drug delivery device may further include a motor body that receives at least a portion of the drive assembly, wherein the motor body includes a stop surface and the lever actuation member includes a motor body contact surface. The motor body contact surface of the lever actuation member engages with the stop surface of the motor body when the lever actuation member is in the locked position and disengages from the stop surface of the motor body when the lever actuation member is in the released position. The stop surface of the motor body may define a flat surface, and the motor body contact surface of the lever actuation member may define a cylindrical surface.

[0009] The drug delivery device may include one or more of the following features, either alone or according to all possible combinations of technologies:

[0010] A drug delivery device may include: a housing; a syringe assembly including a barrel, a stopper, and a cannula, at least a portion of the syringe assembly being located within the housing; a drive assembly configured to move the stopper within the barrel when the drive assembly is actuated, at least a portion of the drive assembly being located within the housing; a lever actuation member movable between a locked position preventing actuation of the drive assembly and a released position allowing actuation of the drive assembly; and a needle cap having a pre-use position, an actuated position, and a post-use position, in which the cannula is located within the needle cap, in which the drive assembly is actuated, and in which the cannula is located within the needle cap in the post-use position, the needle cap being configured to engage the lever actuation member and move the lever actuation member to the released position when the needle cap is in the actuated position;

[0011] - The drug delivery device may further include a syringe holder movable relative to the housing between a first position and a second position, the syringe assembly being received by the syringe holder;

[0012] - The syringe retainer may be configured to move from the first position to the second position when the needle cap is in the actuated position, and when the syringe retainer is in the second position and when the needle cap is in the actuated position, a portion of the cannula of the syringe assembly extends outside the needle cap;

[0013] - When the needle cap is in the pre-use position, a portion of the needle cap may engage the cap stop of the syringe holder to restrict axial movement of the needle cap in at least one direction;

[0014] - The drive assembly may include a plunger body having a plunger rod portion and a drive member, the drive member being configured to move the plunger body within the housing;

[0015] - The longitudinal axis of the plunger rod portion may be spaced apart from and parallel to the longitudinal axis of the drive member;

[0016] -The driving component may include a compression spring;

[0017] - The drive assembly may include a plunger rod cap positioned over at least a portion of the plunger rod portion, the plunger rod cap being configured to engage a plug of the syringe assembly;

[0018] - The drive assembly may include a spring guide member, the drive assembly being positioned on the spring guide member;

[0019] - When the needle cap is in the pre-use position, the needle cap can prevent the lever actuation member from moving from the locked position to the released position;

[0020] -The lever actuation member can rotate about a rotation axis between the locked position and the released position;

[0021] - The lever actuation member may include a limiting surface configured to engage the needle cap and limit rotation of the lever actuation member when the needle cap is in the pre-use position;

[0022] - When the needle cap is in the pre-use position, the limiting surface of the rod actuation member can be spaced apart from the needle cap to form a gap;

[0023] - The needle cap may include a rod contact portion and the rod actuation member includes a needle cap contact surface, the rod contact portion of the needle cap being configured to engage the needle cap contact surface of the rod actuation member, and when the needle cap is in the actuated position, causing the rod actuation member to rotate about the rotation axis from the locked position to the released position;

[0024] - The lever actuation member may define a recessed region, the recessed region being configured to receive a portion of the lever contact portion of the needle cap when the needle cap is in the actuated position;

[0025] - The rod contact portion of the needle cap may define a cylindrical surface and the needle cap contact surface of the rod actuation member may define a flat surface;

[0026] - The motor body may receive at least a portion of the drive assembly, wherein the motor body includes a stop surface and the lever actuation member includes a motor body contact surface, the motor body contact surface of the lever actuation member engaging with the stop surface of the motor body when the lever actuation member is in the locked position, and disengaging from the stop surface of the motor body when the lever actuation member is in the released position;

[0027] - The stop surface of the motor body may define a flat surface and the motor body contact surface of the rod actuation member may define a cylindrical surface. Attached Figure Description

[0028] The above and other features and advantages of this disclosure, as well as the ways in which they are implemented, will become more apparent and the disclosure itself will be better understood from the following description of embodiments thereof, taken in conjunction with the accompanying drawings, wherein:

[0029] 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 drug delivery device.

[0030] Figure 1B This is a perspective view of a drug delivery device according to one aspect of this application, showing the drug delivery device in a pre-use position.

[0031] Figure 2A This is a cross-sectional view of a drug delivery device according to one aspect of this application, showing the storage location of the drug delivery device.

[0032] Figure 2B This is a cross-sectional view of a drug delivery device according to one aspect of this application, showing the drug delivery device in its pre-use position.

[0033] Figure 3 This is a perspective view of a drug delivery device according to one aspect of this application, showing the actuation position of the drug delivery device.

[0034] Figure 4 This is a cross-sectional view of a drug delivery device according to one aspect of this application, showing the actuation position of the drug delivery device.

[0035] Figure 5 This is a perspective view of a drug delivery device according to one aspect of this application, showing the injection position of the drug delivery device.

[0036] Figure 6 This is a cross-sectional view of a drug delivery device according to one aspect of this application, showing the injection position of the drug delivery device.

[0037] Figure 7 This is a perspective view of a drug delivery device according to one aspect of this application, showing the post-use position of the drug delivery device.

[0038] Figure 8 This is a cross-sectional view of a drug delivery device according to one aspect of this application, showing the post-use position of the drug delivery device.

[0039] Figure 9 A perspective view of a drug delivery device according to one aspect of this application, showing a locking clip.

[0040] Figure 10 An exploded perspective view of a drug delivery device according to one aspect of this application, showing a locking clip.

[0041] Figure 11A This is a partial cross-sectional view of a drug delivery device according to one aspect of this application, showing the locking arm of the housing.

[0042] Figure 11B for Figure 11A An enlarged cross-sectional view of the area shown.

[0043] Figure 12 This is a cross-sectional view of a drug delivery device according to one aspect of this application, showing the post-use position of the drug delivery device before complete drug delivery.

[0044] Figure 13 This is a partial cross-sectional view of a drug delivery device according to one aspect of this application, showing the drug delivery device in its pre-use position.

[0045] Figure 14 This is a partial cross-sectional view of a drug delivery device according to one aspect of this application, showing the drug delivery device in its pre-use position.

[0046] Figure 15 This is a partial cross-sectional view of a drug delivery device according to one aspect of this application, showing the transition of the drug delivery device from a pre-use position to an actuated position.

[0047] Figure 16 This is a partial cross-sectional view of a drug delivery device according to one aspect of this application, showing the actuation position of the drug delivery device.

[0048] Figure 17 This is a perspective view of a rod actuating component of a drug delivery device according to one aspect of this application.

[0049] Figure 18 for Figure 17 A cross-sectional view of the rod-actuated component.

[0050] Figure 19A This is a perspective view of the needle cap of a drug delivery device according to one aspect of this application.

[0051] Figure 19B for Figure 19A A partial 3D view of the needle cap.

[0052] Figure 20 This is a perspective view of a syringe holder of a drug delivery device according to one aspect of this application.

[0053] Figure 21 This is a perspective cross-sectional view of the motor body of a drug delivery device according to one aspect of this application.

[0054] Figure 22 This is a cross-sectional view of a drug delivery device according to one aspect of this application, showing the guide groove of the housing.

[0055] Figure 23 This is a perspective view of a drug delivery device according to another aspect of this application, showing the storage location of the drug delivery device.

[0056] Figure 24 For along Figure 23 The sectional view obtained by line 24-24 shown.

[0057] Figure 25 for Figure 23 Top-view perspective of the motor body of the drug delivery device.

[0058] Figure 26 for Figure 25 Bottom-view perspective of the motor body.

[0059] Figure 27 for Figure 23 A frontal perspective perspective view of the plunger body of a drug delivery device.

[0060] Figure 28 for Figure 27 Rear-view perspective of the plunger body.

[0061] Figure 29 for Figure 23 A frontal perspective view of the plunger rod portion of a drug delivery device.

[0062] Figure 30 for Figure 29 Rear-view perspective of the plunger rod section.

[0063] Figure 31 for Figure 23 Top-view perspective of the rod-actuated component of a drug delivery device.

[0064] Figure 32 for Figure 31Bottom perspective view of the rod actuation component of a drug delivery device.

[0065] Figure 33 for Figure 23 A frontal perspective view of the syringe holder of a drug delivery device.

[0066] Figure 34 for Figure 33 Rear perspective view of the syringe holder of a drug delivery device.

[0067] Figure 35 for Figure 23 A frontal perspective perspective of the needle cap of a drug delivery device.

[0068] Figure 36 for Figure 35 Rear-view perspective of the needle cap of the drug delivery device.

[0069] Figure 37 for Figure 23 Top-view perspective of the casing of the drug delivery device.

[0070] Figure 38 for Figure 37 A bottom perspective view of the housing of a drug delivery device.

[0071] Figure 39 for Figure 23 Top-view perspective of the cap of a drug delivery device.

[0072] Figure 40 For along Figure 39 The sectional view obtained from line 40-40 in the diagram.

[0073] Figure 41 for Figure 23 A perspective view of the holder of a drug delivery device.

[0074] Figure 42 for Figure 23 A cross-sectional view of the upper housing of a drug delivery device.

[0075] Figure 43 for Figure 23 A perspective view of the lower housing of a drug delivery device.

[0076] Figure 44 For along Figure 43 The sectional view obtained from line 44-44 in the diagram.

[0077] Figure 45 for Figure 23 A cross-sectional view of a drug delivery device, showing the injection site of the drug delivery device.

[0078] Figure 46 for Figure 23A partial cross-sectional view of a drug delivery system.

[0079] Figure 47 for Figure 23 A cross-sectional view of a drug delivery system.

[0080] Corresponding reference numerals in the accompanying drawings indicate corresponding parts in several views. The examples set forth herein illustrate exemplary aspects of this disclosure, and such 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 intended for implementing the present 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 present invention.

[0082] For the purposes of the description below, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the invention when it has the orientation shown in the drawings. However, it should be understood that various alternative variations may be taken in the invention unless explicitly 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 features relating to the embodiments disclosed herein should not be considered limiting.

[0083] refer to 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 barrel 52, a stopper 54, a cannula 56, and a rigid needle shield (RNS) 58. The lower housing 28, the housing 26, and the upper housing 46 generally form a housing for receiving the various components of the drug delivery device 10, but other suitable housing arrangements may 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 be used. The drug delivery device 10 may be an autoinjector, but the features described herein may 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 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, causing the syringe assembly 16 to move so that the cannula 56 pierces the patient's skin, and to move the stopper 54 within the barrel 52 of the syringe assembly 16 to deliver the 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 location after use ( Figure 7 and 8 As discussed in more detail below, the needle cap 22 is configured to shield the cannula 56 of the syringe assembly 16 from the patient when the drug delivery device 10 is in the pre-use and post-use positions. Specifically, the needle cap 22 is movable between the pre-use, actuated, and post-use positions, wherein a spring 68 biases the needle cap 22 toward the pre-use and post-use positions. The spring 68 is positioned between the needle cap 22 and the syringe holder 24, but other suitable arrangements may 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 both 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 separates from the motor body 42, thereby allowing the drive assembly 40 to move toward the syringe assembly 16. The rotation axis 70 of the lever actuation member 44 extends perpendicular to the longitudinal axis of the drug delivery device 10, but other suitable arrangements may be used.

[0085] Refer again Figure 1A-10The 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 rod opening 88 that receives a rod actuation member 44 and defines a rotation axis 70 of the rod actuation member 44. The rod opening 88 is cylindrical, and the portion of the plunger body 80 defining the rotation axis 70 is also cylindrical to allow smooth rotation of the rod actuation member 44 between a locked position and a released position. When the rod actuation member 44 is engaged with the motor body 42 and is in the locked position, the rod 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 separates 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 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 along the longitudinal direction of the drug delivery device 10, which allows the drug delivery device 10 to be more compact and provides a stronger drive member for injecting high-viscosity drugs.

[0086] The drive assembly 40 further includes a spring guide member 90, which is fixed to the upper housing housing 46 and received within a 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 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 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 cap 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 drug delivery device 10 is moved 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 housing 26 when the drug delivery device 10 is in the injection position, thereby deflecting the audio indicator member 94. When the drug delivery device 10 is moved from the injection position to the post-use position, the audio indicator member 94 disengages from one or more ribs 96 of the housing 26 and contacts the lower housing housing 28 to provide an audible click; however, the audio indicator member 94 may also contact other suitable parts of the drug delivery 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 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. In other words, the drive assembly 40 is actuated by the movement of the needle cap 22 to the actuated position, which causes the lever actuation member 44 to rotate to the release position, thereby releasing or allowing the drive assembly 40 to move to engage with the stopper 54 and dispense medication from the cartridge 52. 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 drug delivery device 10 against the skin surface. As described in detail below, the engagement between the cap 18 and the needle cap 22 prevents the needle cap 22 from moving to engage with the lever actuation member 44. Therefore, removing the cap 18 from the drug delivery device 10 allows actuation of the drug delivery device 10. Figure 1B and 2B As shown, removing the cap 18 from the drug delivery device 10 also removes the RNS 58 from the syringe barrel 52, thereby exposing the cannula 56, which was still received within the needle cap 22 in the pre-use position of the drug delivery 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] refer to Figure 3 and 4 In 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 toward the second sub-assembly 14 within the drug delivery device 10. When the needle cap 22 has moved a sufficient distance within the drug delivery 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.

[0090] refer to Figure 5 and6 In the injection position, the lever actuation member 44 is in the release 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 54 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 cartridge 26 within the drug delivery device 10 until the syringe holder 24 abuts against the stop 102 defined by the cartridge 26. During this initial movement of the syringe assembly 16 and syringe holder 24, with the needle cap 22 pressed 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 barrel 52 of the syringe assembly 16, dispensing medication to the patient from the barrel 52 of the syringe assembly 16 through the cannula 56. 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. When the stopper 54 is at its lowest point, the audio indicator member 94 disengages from one or more ribs 96 of the housing 26 and contacts the lower housing 28 approximately simultaneously to provide the patient with an audible indication that the dose of medication has been delivered. In addition to the audible indication, the medication delivery device 10 provides one or more visual indicators to inform the patient of the status of the medication delivery 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 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 that the 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 medication delivery device 10.

[0091] refer to Figure 7 , 8 11A, 11B, and 12, in the post-use position, when the needle cap 22 is removed from the patient's skin, the needle cap 22 extends to the post-use position to cover the cannula 56. (As shown) Figure 11BAs shown more clearly in the diagram, the housing 26 includes at least one locking arm 106 and the needle cap 22 includes at least one locking protrusion 108. The locking arm 106 of the housing 26 engages the locking protrusion 108 of the needle cap 22 to prevent any further use of the drug delivery device 10 and exposure of the cannula 56 of the syringe assembly 16. During the transition of the drug delivery device 10 from the injection position to the post-use position, the locking arm 106 of the housing 26 deflects to allow the locking protrusion 108 of the needle cap 22 to pass through the housing 26, wherein the locking arm 106 returns to its initial position to prevent the needle cap 22 from moving back toward the pre-use and actuated positions. In the pre-use position of the needle cap 22, a portion of the needle cap 22 engages the cap stop 110 of the syringe retainer 24 to limit axial movement of the needle cap 22 in a direction extending from the second sub-assembly 14 toward the first sub-assembly 12. The cap stop 110 also limits axial movement of the needle cap 22 in the post-use position. After use of the drug delivery device 10, the syringe holder 24 moves within the housing 26 relative to the needle cap 22, allowing the needle cap 22 to extend to its post-use position as the patient removes it from the skin. 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 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 medication delivery device 10.

[0092] refer to Figure 1A-21As discussed above, the engagement between the cap 18 and the needle cap 22 prevents the needle cap 22 from moving to engage with the lever actuation member 44. When the needle cap 22 is in the pre-use and post-use positions, the cannula 56 is positioned within the needle cap 22. The needle cap 22 is configured to actuate the drive assembly 40 when the needle cap 22 is in the actuated position. More specifically, as discussed above, the drive assembly 40 is actuated by the movement of the needle cap 22 to the actuated position, which causes the lever actuation member 44 to rotate to the release position, thereby releasing or allowing the drive assembly 40 to move to engage with the stopper 54 and dispense medication from the cartridge 52. Removing the cap 18 from the medication delivery device 10 allows actuation of the medication delivery device 10. When the needle cap 22 is in the pre-use position, the needle cap 22 prevents the lever actuation member 44 from moving from the locked position or rotating to the release 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 drug delivery device 10 is in the storage position, if the drug delivery device 10 is dropped or impacted to apply force to the lever actuation member 44, the engagement between the limiting surface 134 of the lever actuation member 44 and the needle cap 22 prevents the lever actuation member 44 from rotating fully to allow actuation of the drive assembly 40. Figure 13 As shown, when the drug delivery device 10 is in the storage position and the pre-use position, the limiting surface 134 is spaced apart from the needle cap 22 to form a gap 136 to prevent any increase in frictional force during the movement of the needle cap 22 while still preventing unintended actuation of the drug delivery device 10.

[0093] The body 132 of the lever actuation member 44 further 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 unintentional actuation of the drive assembly 40 during assembly of the drug delivery device 10. The body 132 of the lever actuation member 44 also includes a needle cap contact surface 142, a motor body contact surface 144, and defines a recessed region 146.

[0094] refer to Figure 13-19BAnd 21, when the needle cap 22 moves 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. The lever contact portion 148 is preferably located on the lever actuation arm 152 of the needle cap 22, which is located at the distal or proximal end of the needle cap 22. The lever actuation arm 152 preferably projects radially from the proximal end of the needle cap 22. The lever contact portion 148 of the needle cap 22 defines a cylindrical surface 202, and the needle cap contact surface 142 of the lever actuation member 44 defines a flat surface 204. The engagement between the cylindrical surface 202 of the lever contact portion 148 and the flat surface 204 of the needle cap contact surface 142 reduces the magnitude of the force required to rotate the lever actuation member 44. 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 actuation 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. The stop surface 150 of the motor body 42 defines a flat surface 210, and the motor body contact surface 144 of the lever actuation member 44 defines a cylindrical surface 212. The engagement between the flat surface 210 of the stop surface 150 and the cylindrical surface 212 of the motor body contact surface 144 reduces the magnitude of the force required to rotate the lever actuation member 44.

[0095] refer to Figure 13-18 The recessed region 146 of the lever actuation member 44 provides a clearance for the lever contact portion 148 of the needle cap 22 to allow the lever actuation member 44 to rotate from the locked position to the released position, which ensures actuation of the drug delivery device 10. When the needle cap 22 is in the pre-use position and until the needle cap 22 has been fully moved to the actuated 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 drug delivery device 10, which, as discussed above, prevents unintentional actuation of the drug delivery device 10. When the needle cap 22 is fully moved to the actuated position, the position of 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 44, but instead overlaps with the position of the recessed region 146 in the direction extending in the axial direction of the drug delivery device 10 and engages the needle cap contact surface 142 to rotate the lever actuation member 44 as described above.

[0096] refer to Figure 1A-8In addition to 20, the syringe holder 24 further includes a retaining ring 220 configured to receive and secure the syringe assembly 16. Specifically, the retaining ring 220 is positioned at one end of the syringe holder 24, with the barrel 52 of the syringe assembly 16 extending through the retaining ring 220. The flange of the barrel 52 abuts against the retaining ring 220. The retaining ring 220 is formed of a thermoplastic elastomer, but other suitable materials may be used.

[0097] refer to Figure 13 and 20 The audio indicator member 94 is also configured to restrict movement of the syringe holder 24 when the plunger body 80 is in the pre-use position. As discussed above, the lever actuation member 44 prevents movement of the plunger body 80, and the syringe holder 24 is movable relative to the housing 26. The audio indicator member 94 engages at least one arm 230 of the syringe holder 24 to prevent movement of the syringe holder 24 during movement in the pre-use position of the drug delivery device 10 or during the removal of the cap 18. One or more arms 230 extend radially outward from the syringe holder 24, with a portion of the audio indicator member 94 positioned between one or more arms 230 of the syringe holder 24 such that movement of the syringe holder 24 in a direction extending from the second subassembly 14 toward the first subassembly 12 causes at least one of the one or more arms 230 to engage the audio indicator member 94 to restrict any further movement of the syringe holder 24.

[0098] refer to Figure 4 , 6 As mentioned above, the drug delivery device 10 also includes a visual indicator component 250 configured to provide information about the plunger body 80 from the injection position. Figure 6 ) to the location after use ( Figure 8 The visual indicator 250 is visible through an indicator opening 104 defined by the lower housing 28. The visual indicator 250 is integrally formed with the plunger body 80 and spaced apart from the audio indicator 94, but other suitable configurations may be used. As described above, the visual indicator 220 may use contrasting colors, symbols, patterns, or any other suitable visual markings to indicate various states of the drug delivery device. The rod opening 88 of the plunger body 80 is located between the audio indicator 94 and the visual indicator 250, but other suitable configurations may be used.

[0099] refer to Figure 22The housing 26 defines at least one guide groove 240 extending along the longitudinal axis of the housing 26. One or more guide grooves 240 receive one or more arms 230 of the needle cap 22 and guide the movement of the needle cap 22 within the drug delivery device 10 and relative to the housing 22 between a pre-use position, an actuated position, and a post-use position. The one or more guide grooves 240 fix the lateral position of the needle cap 22 to ensure that the rod contact portion 148 of the needle cap 22 remains aligned with the needle cap contact surface 142 of the rod actuation member 44, thereby ensuring that the rod contact portion 148 engages the needle cap contact surface 142 when the needle cap 22 is moved to the actuated position.

[0100] refer to Figure 14 , 20 And 21, the motor body 42 includes an arm 260 extending from the motor body 42. (As...) Figure 14 As shown, arm 260 is configured to engage the flange 270 of the barrel 52 of syringe assembly 16. Thus, the barrel 52 of syringe assembly 16 is constrained at one end by syringe retainer 24 and at the other end by arm 260 of motor body 42, thereby securing syringe assembly 16 within syringe retainer 24. Motor body 42 includes a pair of arms 260 on each side, but motor body 42 may include one or more arms 260. Arm 260 is L-shaped, but other suitable shapes and configurations may be used.

[0101] refer to Figure 23-47 This illustrates a drug delivery device 300 according to another aspect of the invention. The drug delivery device 300 is similar to... Figure 1A-22 The drug delivery device 10 shown below will be discussed in detail in some aspects. Among other components, the drug delivery device 300 includes a motor body 302, a plunger body 304, a plunger rod portion 306, a rod 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.

[0102] refer to Figure 23-26 The motor body 302 is similar to Figure 1A-22The motor body 302 is similar in function to the motor body 304, but further includes a longitudinal groove 324, one or more reinforcing ribs 326, and one or more clips 328. The longitudinal groove 324 is configured to receive the molding parting line of the plunger body 304 to ensure smooth sliding between the motor body 302 and the plunger body 304. The one or more reinforcing ribs 326 provide additional support for the paired arms 260 of the motor body 302. The one or more clips 328 are received by one or more openings 330 defined by the housing 314 to secure the motor body 302 to the housing 314, which will be discussed in more detail below. The one or more clips 328 include an inclined surface 332 and a flat surface 334, the flat surface being configured to allow the one or more clips 328 to be inserted into the one or more openings 330 of the housing 314, but preventing the one or more clips 328 from being easily removed once inserted into the one or more openings 330 of the housing 314. The bottom surface 336 of the motor body 302 includes a chamfered portion 338 to facilitate the assembly of the drug delivery device 300.

[0103] refer to Figure 24 and 27 -30, the plunger body 304 and the plunger rod portion 306 are formed separately, rather than integrally. Furthermore, the drug delivery device 300 does not include a plunger rod cap 92. The plunger body 304 defines an opening 340 that receives the plunger rod clamp 342 of the plunger rod portion 306. The plunger rod clamp 342 is barbed and configured to be inserted into the opening 340 of the plunger body 304, but 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 received within 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 protruding plunger body stops 346 can contact the plunger body 304. A biasing member 348 engages the plunger body 304 during the insertion of the plunger rod clamp 342 into the opening 340 of the plunger body 304 and biases the plunger rod portion 306 toward 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 can be used.

[0104] The plunger rod portion 306 further includes a plug interface 350 received by the plug 54. The plug interface 350 is a cross-shaped projection, but other suitable shapes and configurations may 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 be used. The plunger body 304 includes a rod rib 352 extending into a rod opening 88 of the plunger body 304. The rod rib 352 is configured to be received by a rod actuation member 308, as discussed in more detail below.

[0105] refer to Figure 31 and 32 The lever actuating component 308 is similar to that described above and in Figure 1A-22 The lever actuation member 44 shown is functionally similar to this lever actuation member. However, the lever actuation member 308 defines a groove 354 at the rotation axis 70, which receives the rod rib 352 of the plunger body 304. The engagement between the groove 354 and the rod rib 352 prevents relative lateral movement between the plunger body 304 and the lever actuation member 308. Figure 1A-22 Compared to the needle cap contact surface 142 of the lever actuation member 44, the needle cap contact surface 142 of the lever actuation member 308 has a larger surface area.

[0106] refer to Figure 33 and 34 The syringe retainer 310 is similar to Figure 1A-22 The syringe holder 24 is similar in function to the syringe holder. However, the syringe holder 310 further includes a plurality of ribs 356 extending circumferentially around the syringe holder 310. The plurality of ribs engage springs 68. The retaining ring 220 of the syringe holder 310 further includes a plurality of radially inwardly extending protrusions 358. The plurality of 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 plurality of protrusions 358 are resilient and compressible when the syringe assembly 16 is received within the syringe holder 310.

[0107] refer to Figure 35 and 36 The needle cap 312 is similar to Figure 1A-22 The needle cap 22 functions similarly to the needle cap. 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 one or more housing ribs 362 to guide movement of the needle cap 312 relative to the housing 314.

[0108] refer to Figure 37 , 38 Boxes 314 are similar to 46 and 47. Figure 1A-22The housing 26 is similar in function to the housing. As discussed above, the housing 314 includes one or more openings 330 for receiving the one or more clamps 328 of the motor body 302. The housing 314 includes one or more needle cap clamps 364 that engage one or more clamping surfaces 366 of the needle cap 312. The one or more clamping surfaces 366 of the needle cap 312 are flat, but other suitable shapes and configurations may be used. The one or more needle cap clamps 364 are configured to restrict axial movement of the needle cap 312 relative to the housing 314. The housing 314 further includes one or more motor body ribs 368 and one or more upper housing housing ribs 370, which are configured to engage corresponding portions of the motor body 302 and the upper housing housing 320 to facilitate assembly of the drug delivery device 300. The housing 314 also includes one or more syringe retainer stops 372, which are configured to engage portions of the syringe retainer 310 to restrict axial movement of the syringe retainer 310 relative to the housing 314. although Figure 46 It is not shown in the diagram, but the locking clip 64 can also be used with the drug delivery device 300.

[0109] refer to Figures 39-44 Hat 316 is similar to the one described above and Figure 1A-22 The cap 18 shown is similar in function to this cap. The cap 316 includes one or more protrusions 374 received by one or more cap openings 376 defined by the pin cap 312, the protrusions 374 being relative to... Figure 1A-22 The 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 cap 312 when it moves from the pre-use position to the actuated position. For example, when the drug delivery device 300 is in the storage position and the cap 316 is secured to the lower housing housing 322, if the drug delivery device is dropped or impacted to exert force on the needle cap 312, the rod actuation member 308, and / or other members, the one or more protrusions 374 restrict the movement of the needle cap 312, preventing any unintended actuation of the drug delivery device 300. The cap 316 further 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 one or more retainer clips 378 and the one or more 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-22The upper housing 46 and lower housing 28 shown are functionally similar to the upper housing and lower housing. However, the lower housing 322 has a cap interface 386 to receive one or more lower housing clips 384 of the cap 316.

[0110] refer to Figure 45 The drug delivery device 300 is shown in the injection position. The injection depth of the cannula 56 is determined by the contact at point X between the syringe holder 310 and the housing 314 and the contact at point Y between the needle cap 312 and the syringe holder 310.

[0111] refer to Figure 45 The drug delivery device 300 includes an audio indicator component 388, which is similar to that described above and... Figure 1A-22 The audio indicator component 94 shown is similar in function to this audio indicator component. 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 drug delivery device 300 is transitioned to the post-use position. The audio indicator component 388 is configured to engage one or more ribs 390 of the housing 314 when the drug delivery device 300 is in the injection position, thereby deflecting the audio indicator component 388. When the drug delivery device 300 transitions from the injection position to the post-use position, the audio indicator component 388 disengages from one or more ribs 390 of the housing 314 and contacts the lower housing housing 322 to provide an audible click. However, the distal ends 392 of the one or more ribs 390 of the housing 314 are tilted rearward toward the upper housing housing 320, engaging with the upper housing housing 322. Figure 1A-22 Compared to the arrangement of one or more ribs 96 in the housing 26 under discussion, this advantageously provides a greater audible click.

[0112] In one aspect or embodiment, the angle Z of the distal end 392 of one or more ribs 390 of the housing 314 relative to a plane extending perpendicular to the longitudinal axis of the drug delivery device 300 is greater than 5 degrees. 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.

[0113] 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.

[0114] Although this disclosure has been described as having an exemplary design, further modifications to this disclosure are possible within its spirit and scope. Therefore, this application is intended to cover any variations, uses, or modifications of the general principles of the use of this disclosure. Furthermore, this application is intended to cover any deviations from this disclosure that are known or common practice within the art to which this disclosure pertains and fall within the limitations of the appended claims.

Claims

1. A drug delivery device, comprising: case; A housing, which is housed within the casing; A syringe holder slidably and at least partially housed within the housing, the syringe holder including a proximal end, a distal end, and a sidewall between the proximal end and the distal end, the proximal end, the distal end, and the sidewall defining the interior of the syringe holder; A syringe assembly including a barrel having a proximal end and a distal end and a sidewall therebetween, the proximal end of the barrel including at least one flange, the distal end of the barrel including a cannula, the proximal end, the distal end and the sidewall of the barrel being configured to retain a mixture and a stopper, the syringe assembly being at least partially housed within the interior of the syringe retainer; A drive assembly configured to move the plug within the cylinder when the drive assembly is actuated, at least a portion of the drive assembly being located within the housing; as well as The needle cap has a pre-use position, an actuated position, and a post-use position, wherein in the pre-use position the cannula is positioned inside the needle cap, in the actuated position the drive assembly is actuated, and in the post-use position the cannula is positioned inside the needle cap. The housing includes a radially inwardly extending stop defined by the housing, and the proximal end of the syringe holder is configured to abut against the stop when the drive assembly is actuated.

2. The drug delivery device according to claim 1, wherein, The sidewall of the syringe retainer comprises a cylindrical shape having an opening at its proximal end and also an opening at its distal end.

3. The drug delivery device according to claim 2, wherein, The syringe retainer includes a plurality of radially outwardly extending arms at its proximal end, the plurality of radially outwardly extending arms being configured to engage with the housing.

4. The drug delivery device according to claim 3, wherein, The plurality of radially outwardly extending arms include three arms that are evenly spaced.

5. The drug delivery device according to claim 4, wherein, The syringe retainer further includes an elastic ring disposed at its proximal end, the elastic ring being configured such that it engages with the at least one flange of the syringe assembly.

6. The drug delivery device according to claim 5, wherein, The elastic ring includes a plurality of radially outwardly extending arms disposed adjacent to the plurality of radially outwardly extending arms of the syringe retainer.

7. The drug delivery device according to claim 1, wherein, The syringe retainer further includes an elastic ring disposed at its proximal end, the elastic ring being configured such that it engages with the at least one flange of the syringe assembly.

8. The drug delivery device according to claim 7, wherein, The resilient ring includes a plurality of radially inwardly extending protrusions configured to engage with the barrel of the syringe assembly.

9. The drug delivery device according to claim 8, wherein, The plurality of radially inwardly extending protrusions include four protrusions that are evenly spaced.

10. The drug delivery device according to claim 1, wherein, The syringe retainer includes a plurality of ribs disposed at its distal end.

11. The drug delivery device according to claim 10, wherein, The plurality of ribs are arranged circumferentially around the sidewall of the syringe holder.

12. The drug delivery device according to claim 11, wherein, The plurality of ribs extend longitudinally along the sidewall of the syringe holder.

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