Drug delivery device

Abstract

A drug delivery device comprising a housing, a syringe assembly comprising a barrel, a bung, and a cannula, wherein at least a portion of the syringe assembly is positioned within the housing, and a drive assembly comprising a plunger body configured to move the bung within the barrel upon actuation of the drive assembly, wherein at least a portion of the drive assembly is positioned within the housing. The plunger body has a pre-use position prior to movement of the plunger body, an injection position in which the plunger body moves the bung within the barrel, and a post-use position in which movement of the plunger body has ceased. The device further comprises an audible indicator member configured to provide an audible indication of the transition of the plunger body from the injection position to the post-use position.

Description

[0001] This application is a divisional application of Chinese invention patent application No. 202080016828.X, which is entitled "Automatic Injector with Audio Indicator" and whose international application date is February 26, 2020, PCT / EP2020 / 055006 and has entered the Chinese national phase. Technical Field

[0002] This disclosure relates generally to drug delivery devices, and more specifically to autoinjectors. 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 reservoir pre-filled with the liquid therapeutic preparation and some type of automated needle injection mechanism that can be triggered by the user. Many of these devices (such as autoinjectors) are designed to assemble the reservoir (such as a pre-filled syringe) into the device during device assembly. In addition to an automated needle injection mechanism, many drug delivery devices also automatically shield the needle after use to prevent any accidental contact with the needle. Summary of the Invention

[0004] In one aspect, a drug delivery device includes: a housing; a syringe assembly including a barrel, a stopper, and a cannula, wherein at least a portion of the syringe assembly is positioned within the housing; and a drive assembly including a plunger body configured to move the stopper within the barrel upon actuation of the drive assembly, wherein at least a portion of the drive assembly is positioned within the housing. The plunger body has a pre-use position before movement, an injection position where the plunger body moves the stopper within the barrel, and a post-use position where movement of the plunger body has ceased. The device further includes an audible indicator component configured to provide audible indication of the plunger body transitioning from the injection position to the post-use position.

[0005] The audio indicator component may have a biased position and a release position, wherein the audio indicator is positioned in the biased position when the plunger body is in the injection position and in the release position when the plunger body is in the post-use position. Movement of the audio indicator from the biased position to the release position can cause an audible indication. When the plunger body is in the pre-use position, the audio indicator component may be positioned in an unbiased position. The audio indicator component may engage with a portion of the housing to provide audible indication. The housing may include a lower housing shell, an upper housing shell, and a housing received by the lower housing shell, wherein the lower housing shell includes an indicator platform, and the audio indicator component engages with the indicator platform to provide the audible indication.

[0006] The housing may include ribs extending in the longitudinal direction of the device, wherein the audio indicator member engages the ribs to move the audio indicator member from a non-biased position to a biased position, and the audio indicator member disengages from the ribs to move the audio indicator member from the biased position to a release position to induce an audible indication. The housing may include the ribs. The ribs may include inclined surfaces configured to transition the audio indicator member from the non-biased position to the biased position. The ribs may extend only a portion of the length of the housing. The audio indicator member may be integrally formed with the plunger body.

[0007] The device may further include a visual indicator component configured to provide visual indication of the plunger body transitioning from the injection position to the post-use position. When the plunger body is in the post-use position, the visual indicator component is visible through an indicator opening defined by the housing. The housing may include a lower housing housing defining the indicator opening. The visual indicator component may be integrally formed with the plunger body, wherein the visual indicator component is spaced apart from the audio indicator component.

[0008] The drive assembly may further include a drive member configured to bias the plunger body from a pre-use position to an injection position and to a post-use position. The device may also include a needle cap having a pre-use position in which the cannula is positioned within the needle cap, an actuation position in which the needle cap is configured to actuate the drive assembly, and a post-use position in which the cannula is positioned within the needle cap. The device may further include 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, wherein the needle cap engages the lever actuation member and moves the lever actuation member to the released position when the needle cap is in the actuation position.

[0009] The device may also include a syringe holder movable relative to the housing, wherein the syringe assembly is received by the syringe holder. The acoustic actuator component may be configured to restrict movement of the syringe holder when the plunger body is in the pre-use position.

[0010] The device may include one or more of the following features, either individually or according to all possible combinations of the technologies:

[0011] - 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 positioned within the housing; and a drive assembly including a plunger body configured to move the stopper within the barrel when the drive assembly is actuated, at least a portion of the drive assembly being positioned within the housing, the plunger body having a pre-use position before the plunger body moves, an injection position in which the plunger body moves the stopper within the barrel, and a post-use position in which the movement of the plunger body has stopped; and an audio indicator component configured to provide audible indication of the plunger body transitioning from the injection position to the post-use position.

[0012] - The audio indicator component may have a biased position and a release position for a portion of the audio indicator component engaging housing. When the plunger body is in the injection position, the audio indicator is positioned in the biased position, and when the plunger body is in the post-use position, the audio indicator is positioned in the release position. The movement of the audio indicator from the biased position to the release position causes an audible indication.

[0013] - When the plunger body is in the pre-use position, the audio indicator component can be positioned in the unbiased position;

[0014] -The audio indicator component can be joined to a portion of the housing to provide an audio indication;

[0015] - The housing may include a lower housing, an upper housing, and a housing received by the lower housing, the lower housing including an indicator platform, and the audio indicator component engaging the indicator platform to provide the audio indication;

[0016] - The housing may include ribs extending in the longitudinal direction of the device, the audio indicator member engaging the ribs to move the audio indicator member from an unbiased position to a biased position, and the audio indicator member disengaging from the ribs to move the audio indicator member from the biased position to a release position to induce an audible indication.

[0017] - The outer casing may include a lower outer casing, an upper outer casing, and a housing received by the lower outer casing, the housing including the rib;

[0018] - The rib may include an inclined surface configured to shift the audio indicator member from the unbiased position to the biased position;

[0019] - The rib may extend only a portion of the length of the box body;

[0020] - The audio indicator component can be integrally formed with the plunger body;

[0021] - The drug delivery device may include a visual indicator component configured to provide visual indication of the plunger body transitioning from the injection position to the post-use position;

[0022] - When the plunger body is in the used position, the visual indicator component is visible through the indicator opening defined by the housing;

[0023] -The housing may include a lower housing that defines the indicator opening;

[0024] - The visual indicator component can be integrally formed with the plunger body, and the visual indicator component is spaced apart from the audio indicator component;

[0025] - The drug delivery device may include a syringe holder movable relative to the housing, wherein the acoustic actuator component is configured to restrict movement of the syringe holder when the plunger body is in the pre-use position. Attached Figure Description

[0026] 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 by referring to the following description of embodiments of this disclosure taken in conjunction with the accompanying drawings, wherein:

[0027] 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.

[0028] Figure 1B This is a perspective view of the drug delivery device in Figure 1, showing the device in its pre-use position.

[0029] Figure 2A This is a cross-sectional view of the drug delivery device in Figure 1, showing the storage location of the device.

[0030] Figure 2B This is a cross-sectional view of the drug delivery device in Figure 1, showing the device in its pre-use position.

[0031] Figure 3This is a perspective view of the drug delivery device in Figure 1, showing the actuation position of the device.

[0032] Figure 4 This is a cross-sectional view of the drug delivery device in Figure 1, showing the actuation position of the device.

[0033] Figure 5 This is a perspective view of the drug delivery device in Figure 1, showing the injection position of the device.

[0034] Figure 6 This is a cross-sectional view of the drug delivery device in Figure 1, showing the injection site of the device.

[0035] Figure 7 This is a perspective view of the drug delivery device in Figure 1, showing the device in its post-use position.

[0036] Figure 8 This is a cross-sectional view of the drug delivery device in Figure 1, showing the device in its post-use position.

[0037] Figure 9 This is a perspective view of the drug delivery device in Figure 1, showing the locking clip.

[0038] Figure 10 This is an exploded perspective view of the drug delivery device in Figure 1, showing the locking clip.

[0039] Figure 11A This is a partial cross-sectional view of the drug delivery device in Figure 1, showing the locking arm of the housing.

[0040] Figure 11B yes Figure 11A An enlarged cross-sectional view of the area shown.

[0041] Figure 12 This is a cross-sectional view of the drug delivery device in Figure 1, showing the post-use position of the device before complete drug delivery.

[0042] Figure 13 This is a partial cross-sectional view of the drug delivery device in Figure 1, showing the storage location of the device.

[0043] Figure 14 This is a perspective view of the lower outer casing of the drug delivery device shown in Figure 1.

[0044] Figure 15 This is a perspective view of the box of the drug delivery device shown in Figure 1.

[0045] Figure 16 This is a perspective view of the plunger body of the drug delivery device in Figure 1.

[0046] Figure 17 This is a perspective view of a drug delivery device according to another aspect of this application, showing the storage location of the device.

[0047] Figure 18 It is along Figure 17 The sectional view shown is taken from line 18-18.

[0048] Figure 19 yes Figure 17 Top perspective view of the motor body of the drug delivery device.

[0049] Figure 20 yes Figure 19 A three-dimensional view of the bottom of the motor body.

[0050] Figure 21 yes Figure 17 A front perspective view of the plunger body of a drug delivery device.

[0051] Figure 22 yes Figure 21 Rear perspective view of the plunger body.

[0052] Figure 23 yes Figure 17 A front perspective view of the plunger rod portion of a drug delivery device.

[0053] Figure 24 yes Figure 23 Rear perspective view of the plunger rod section.

[0054] Figure 25 yes Figure 17 Top perspective view of the lever actuation component of the drug delivery device.

[0055] Figure 26 yes Figure 25 A three-dimensional view of the bottom of the lever actuation component of the drug delivery device.

[0056] Figure 27 yes Figure 17 A front perspective view of the syringe holder of a drug delivery device.

[0057] Figure 28 yes Figure 27 Rear perspective view of the syringe holder of a drug delivery device.

[0058] Figure 29 yes Figure 17 A front perspective view of the needle cap of a drug delivery device.

[0059] Figure 30 yes Figure 29 Rear perspective view of the needle cap of the drug delivery device.

[0060] Figure 31 yes Figure 17 A top perspective view of the casing of the drug delivery device.

[0061] Figure 32 yes Figure 31 A perspective view of the bottom of the box of the drug delivery device.

[0062] Figure 33 yes Figure 17 A three-dimensional view of the top of the cap of a drug delivery device.

[0063] Figure 34 It is along Figure 33 The sectional view taken from line 34-34 in the figure.

[0064] Figure 35 yes Figure 17 A perspective view of the holder of a drug delivery device.

[0065] Figure 36 yes Figure 17 A cross-sectional view of the upper outer casing of the drug delivery device.

[0066] Figure 37 yes Figure 17 A perspective view of the lower outer casing of a drug delivery device.

[0067] Figure 38 It is along Figure 37 The sectional view taken from line 38-38 in the figure.

[0068] Figure 39 yes Figure 17 A cross-sectional view of the drug delivery device, showing the injection site of the device.

[0069] Figure 40 yes Figure 17 A partial cross-sectional view of a drug delivery system.

[0070] Figure 41 yes Figure 17 A cross-sectional view of a drug delivery system.

[0071] The corresponding reference symbols denote the 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

[0072] The following description is provided to enable those skilled in the art to make and use the embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will remain 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.

[0073] For the purposes described below, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives should be understood in relation to the orientation of the invention in the accompanying drawings. However, it should be understood that various alternative variations of the invention may be taken unless explicitly stated otherwise. It should also be understood that the specific devices shown in the drawings and described in the following description are merely exemplary embodiments of the invention. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0074] refer to Figures 1A to 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 outer housing 28. The second sub-assembly 14 includes a drive assembly 40, a motor 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 guard (RNS) 58. Although an RNS is used, other suitable needle guard arrangements may also be utilized. The lower outer housing 28, the housing 26, and the upper outer housing 46 generally form a housing for the various components of the receiving device 10, but other suitable housing arrangements may also be utilized. 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 utilized. The drug delivery device 10 may be an autoinjector, but the features described herein may be incorporated into other suitable drug delivery devices.

[0075] The drug delivery device 10 is configured to automatically deliver a dose of medication from the syringe assembly 16 to a patient upon actuation of the device 10. More specifically, upon actuation of the drug delivery device 10, 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 pierces the patient's skin, and displacing 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 Figure 2A ), position before use ( Figure 1B and Figure 2B ), Actuation position ( Figure 3 and Figure 4 ), injection site ( Figure 5 and Figure 6 ), and the location after use ( Figure 7 and Figure 8As discussed in more detail below, when the device 10 is in the pre-use and post-use positions, the needle cap 22 is configured to isolate the cannula 56 of the syringe assembly 16 from the patient. 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 also be used. The lever actuation member 44 is movable between a locked position that prevents movement of the drive assembly 40 and a released position that allows movement of the drive assembly 40. More specifically, the lever actuation member 44 is rotatable about a rotation axis 70 between the locked and released positions. When the lever actuation member 44 is in the locked position, the lever actuation member 44 engages with the motor body 42 and the drive assembly 40 to prevent movement of the drive assembly 40. When the lever actuation member 44 is in the released position, the lever actuation member 44 disengages 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 device 10, but other suitable arrangements can be used.

[0076] Refer again to Figure 1 to Figure 10 The drive assembly 40 includes a plunger body 80 having a plunger rod portion 82 and a drive member 84. The plunger body 80 has a pre-use position before the plunger body 80 is moved. Figure 2B ), the plunger body 80 moves the injection position of the plug 54 within the cylinder 52 ( Figure 6 The movement of the plunger body 80 has stopped in the post-use position. Figure 8 The drive member 84 is a compressed spring received within a drive opening 86 defined by the plunger body 80, but other suitable drive members may be used, including but not limited to compressed gas, electric motors, 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 subassembly 14 toward the first subassembly 12. The plunger body 80 defines a lever opening 88 for receiving the lever actuation member 44 and defines the axis of rotation 70 of the lever actuation member 44. When the lever actuation member 44 is in a locked position through engagement with the motor body 42, the lever actuation member 44 prevents movement of the plunger body 80. As the lever actuation member 44 rotates from the locked position to the released position, the lever actuation member 44 disengages from the motor body 42, thereby allowing the drive member 84 to move the plunger body 80 and the plunger rod portion 82 toward the first 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.

[0077] The drive assembly 40 also includes a spring guide member 90 fixed to the upper housing 46 and received within a drive opening 86 of the plunger body 80. The drive member 84 is received by the spring guide member 90 such that it is positioned between the plunger body 80 and the spring guide member 90. The drive assembly 40 also includes a plunger rod cap 92 that receives a plunger rod portion 82 of the plunger body 80. The plunger rod cap 92 is configured to guide the plunger rod portion 82 into the 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 two separate components or may be integrally formed as a single piece.

[0078] 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 housing 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 the ribs 96 of the housing 26 and contacts the lower outer housing 28 to provide an audible click, but the audio indicator member 94 may also contact other suitable parts of the device 10 to provide an audible indication.

[0079] refer to Figures 1A to 2B In the storage position, cap 18 is secured to the lower outer housing 28 and engages with needle cap 22. Movement of needle cap 22 from the pre-use position to the actuated position causes engagement between needle cap 22 and lever actuation member 44, thereby actuating drive assembly 40. After removing cap 18 by grasping outer portion 20, needle cap 22 can be moved from the pre-use position to the actuated position by pressing needle cap 22 against the patient's skin surface and axially pressing device 10 against the skin surface. As detailed below, the engagement between cap 18 and needle cap 22 prevents needle cap 22 from moving to engage with lever actuation member 44. Therefore, removing cap 18 from device 10 allows actuation of device 10. Removing cap 18 from device 10 (as described below) Figure 1B and Figure 2B (As shown) The RNS 58 is also removed from the syringe barrel 52, thereby exposing the cannula 56, which is still received within the needle cap 22 in the pre-use position of 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.

[0080] refer to Figure 3 and Figure 4In the actuated position, cap 18 is removed, and needle cap 22 is positioned in the actuated position by engaging with the patient's skin surface, which moves needle cap 22 further toward the second sub-assembly 14 within the device 10. When needle cap 22 has moved a sufficient distance within the device 10, a portion of needle cap 22 engages lever actuation member 44, causing lever actuation member 44 to rotate about rotation axis 70 from the locked position to the released position.

[0081] refer to Figure 5 and Figure 6 In the injection position, the lever actuation member 44 is in the released position, which allows the plunger body 80 of the drive assembly 40 to move toward the first sub-assembly 12, such that the plunger body 80 or plunger rod cap 92 engages the stopper of the syringe assembly 16. The initial engagement of the drive assembly 40 with the syringe assembly 16 moves the syringe assembly 16 and syringe retainer 24 within the device 10 and relative to the housing 26 until the syringe retainer 24 abuts the stop 102 defined by the housing 26. During the initial movement of the syringe assembly 16 and syringe retainer 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, moves the stopper 54 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 into the patient. The plunger body 80 continues to move until the stopper 54 bottoms out on the barrel 52 of the syringe assembly 16. When or just before the stopper 54 bottoms out, the audible indicator member 94 disengages from the rib 96 of the housing 26 and contacts the lower housing 28 approximately simultaneously to provide the patient with an audible indication that a dose of medication has been delivered. In addition to the audible indication, the medication delivery device 10 provides one or more visual indicators to notify the patient of the status of the device 10. Specifically, the housing 26 may be formed of a transparent material to allow visual confirmation of the movement of the stopper 54 and / or 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 of medication has been delivered. The visual indicators may utilize contrasting colors, symbols, patterns, or any other suitable visual markings to indicate various states of the device.

[0082] refer to Figure 7 , Figure 8 , Figure 11A , Figure 11B and Figure 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 protect the cannula 56. (As shown) Figure 11BAs shown more clearly, housing 26 includes at least one locking arm 106, and needle cap 22 includes at least one locking protrusion 108, although other suitable configurations may also be utilized. The locking arm 106 of housing 26 engages the locking protrusion 108 of needle cap 22 to prevent any further use of device 10 and exposure of the cannula 56 of syringe assembly 16. During the transition of device 10 from the injection position to the post-use position, the locking arm 106 of housing 26 deflects to allow the locking protrusion 108 of needle cap 22 to pass through housing 26, wherein the locking arm 106 returns to its original position to prevent needle cap 22 from moving back toward the pre-use and actuated positions. In the pre-use position of needle cap 22, a portion of needle cap 22 engages the cap stop 110 of syringe holder 24 to limit axial movement of needle cap 22 in a direction extending from the second sub-assembly 14 toward the first sub-assembly 12. After use of device 10, syringe retainer 24 is displaced within housing 26 relative to needle cap 22, allowing needle cap 22 to extend to its post-use position when the patient removes it from the skin surface. Figure 12 As shown, regardless of the position of the stopper 54 within the barrel 52 of the syringe assembly 16, the needle cap 22 will move to the post-use position when it is removed from the patient's skin. Therefore, if the patient removes the needle cap 22 from the skin after only a portion of the medication has been delivered, the needle cap 22 will still move to the post-use position and will prevent further use of the device 10.

[0083] Refer to Figure 1 to Figure 8 and Figures 12 to 16 As discussed above, the plunger body 80 of the drive assembly 40 includes an audible indicator member 94 configured to provide an audible indication of the plunger body 80 transitioning from an injection position to a post-use position. The audible indication may be a click, tap, ring, or any other suitable sound and / or tactile indication. The audible indicator member 94 has a biased position where it engages a portion of the housing 26. Figure 6 ), unbiased position ( Figure 2B and Figure 4 ), and release location ( Figure 8 However, the audio indicator component 94 can also engage other parts of the device 10 to bias the audio indicator component 94. When the plunger body 80 is in the injection position ( Figure 6 When the audio indicator 94 is in the offset position, and when the plunger body 80 is in the post-use position ( Figure 8 When the biased position is reached, the audio indicator 94 is positioned in the released position. Movement of the audio indicator member 94 from the biased position to the released position triggers an audible indication. Figure 2B As shown, when the plunger body 80 is in the pre-use position, the audio indicator component 94 is positioned in the unbiased position.

[0084] As discussed above, housing 26, lower outer housing 28, and upper outer housing 46 can form an enclosure for device 10, wherein upper outer housing 46 abuts lower outer housing 28, and lower outer housing 28 receives housing 26. Audio indicator member 94 engages a portion of lower outer housing 28 to provide audio indication. More specifically, as... Figure 14 As shown more clearly, the lower housing 28 includes an indicator platform 202. An audio indicator component 94 engages the indicator platform 202 to provide an audio indication, but the audio indicator component 94 may also engage other parts of the device 10 to provide an audio indication.

[0085] Refer again to Figure 1 to Figure 8 and Figures 12 to 16 As discussed above, the housing 26 includes at least one rib 96 extending in the longitudinal direction of the device 10. Figure 15 As shown, housing 26 includes two ribs 96. The audio indicator member 94 engages the ribs 96 to move the audio indicator member 94 from an unbiased position to a biased position. The audio indicator member 94 disengages from the ribs 96 to move the audio indicator member 94 from the biased position to a release position to induce an audible indication. Specifically, during actuation of device 10, as the plunger body 80 moves relative to the motor body 42, the audio indicator member 94 moves from... Figure 4 The unbiased position shown moves to Figure 6 The biased position shown causes the audio indicator member 94 to engage the rib 96 and deflect the audio indicator member 94, thereby moving the audio indicator member 94 to the biased position. The audio indicator member 94 continues to slide along the rib 96 until the audio indicator member 94 reaches the end of the rib 96. After disengaging from the rib 96, the audio indicator member 94 transitions to a release position and contacts the indicator platform 202 to provide an audible indication. The audio indicator member 94 may provide an audible indication just before the stopper 54 touches the bottom of the cylinder 52, but the audio indicator member 94 may provide an audible indication approximately simultaneously with the stopper 54 touching the bottom, or it may delay the audible indication for a predetermined time after a dose of medication has been delivered. The rib 96 includes a sloped surface 204 configured to transition the audio indicator member 94 from the unbiased position to the biased position. The sloped surface 204 provides a smooth transition from the unbiased position to the biased position. Rib 96 extends only a portion of the length of housing 26, but other suitable configurations can be utilized. Audio indicator component 94 is integrally formed with plunger body 80 and moves with plunger body 80, but audio indicator component 94 can be formed separately from plunger body 80.

[0086] refer to Figure 13The audio indicator member 94 is 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. The syringe holder 24 is movable relative to the housing 26. The audio indicator member 94 engages at least one arm 210 of the syringe holder 24 to prevent movement of the syringe holder 24 during movement in the pre-use position of the device 10 or during removal of the cap 18. The arms 210 extend radially outward from the syringe holder 24, with a portion of the audio indicator member 94 positioned between the arms 210 of the syringe holder 24 such that movement of the syringe holder 24 in a direction extending from the second sub-assembly 14 toward the first sub-assembly 12 causes at least one of the arms 210 to engage the audio indicator member 94 to restrict any further movement of the syringe holder 24.

[0087] refer to Figure 2B , Figure 6 , Figure 8 and Figure 16 As described above, the device 10 also includes a visual indicator component 220, which is configured to provide the plunger body 80 from the injection position ( Figure 6 Visual indications for transitioning to the post-use location ( Figure 8 The visual indicator component 220 is visible through the indicator opening 104 defined by the lower housing 28. The visual indicator component 220 is integrally formed with the plunger body 80 and spaced apart from the audio indicator component 94, but other suitable configurations may be used. As described above, the visual indicator component 220 may use contrasting colors, symbols, patterns, or any other suitable visual markings to indicate various states of the device.

[0088] refer to Figures 17 to 41 This illustrates a drug delivery device 300 according to another aspect of the invention. The drug delivery device 300 is similar to... Figures 1A to 16 The drug delivery device 10 shown below will be discussed in detail for some of its differences. The drug delivery device 300 specifically includes a motor body 302, a plunger body 304, a plunger rod portion 306, a lever actuation member 308, a syringe holder 310, a needle cap 312, a housing 314, a cap 316, a holder 318, an upper outer housing 320, and a lower outer housing 322.

[0089] refer to Figures 17 to 20 Motor body 302 and Figures 1A to 16The motor body 302 is similar in appearance and function to the motor body 302, but also includes a longitudinal groove 324, reinforcing ribs 326, and a clip 328. The longitudinal groove 324 is configured to receive the molding split line of the plunger body 304 to ensure smooth sliding between the motor body 302 and the plunger body 304. The reinforcing ribs 326 provide additional support for the pair of arms 260 of the motor body 302. The clip 328 is received by an opening 330 defined by a housing 314 to secure the motor body 302 to the housing 314, as will be discussed in more detail below. The clip 328 includes an inclined surface 332 and a flat surface 334, configured to allow insertion of the clip 328 into the opening 330 of the housing 314, but prevents easy removal of the clip 328 once inserted into the opening 330 of the housing 314. The bottom surface 336 of the motor body 302 includes a chamfered portion 338 to aid in the assembly of the device 300.

[0090] refer to Figure 18 and Figures 21 to 24 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 cap 92. The plunger body 304 defines an opening 340 for receiving a plunger rod clamp 342 of the plunger rod portion 306. The plunger rod clamp 342 is barbed and configured to insert into the opening 340 of the plunger body 304, but is not easily removed from the opening 340; however, other suitable shapes and configurations can be utilized. The plunger rod clamp 342 defines a central opening 344 that allows the plunger rod clamp 342 to compress as it is inserted into the opening 340 of the plunger body 304 and to expand to its original shape once received within the plunger body 304. The plunger rod portion 306 includes a plunger body stop 346 and a biasing member 348. When the plunger rod clamp 342 is inserted into the opening 340 of the plunger body 304, the plunger body stop 346 (which may be one or more protrusions) contacts the plunger body 304. The 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 no gaps 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 utilized.

[0091] 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 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 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.

[0092] refer to Figure 25 and Figure 26 The lever actuating component 308 is the same as described above and Figures 1A to 16 The lever actuation member 44 shown is similar in appearance and function. However, the lever actuation member 308 defines a groove 354 at the axis of rotation 70, the groove 354 receiving a lever rib 352 of the plunger body 304. The engagement between the groove 354 and the lever rib 352 prevents relative lateral movement between the plunger body 304 and the lever actuation member 308. The needle cap contact surface 142 of the lever actuation member 308 includes a... Figures 1A to 16 The needle cap contact surface 142 of the lever actuation component 44 is larger than the surface.

[0093] refer to Figure 27 and Figure 28 Syringe holder 310 and Figures 1A to 16 The syringe retainer 24 is similar in appearance and function. However, the syringe retainer 310 also includes a plurality of ribs 356 extending circumferentially around the syringe retainer 310. The plurality of ribs engage springs 68. The retaining ring 220 of the syringe retainer 310 also 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 retainer 310. The plurality of protrusions 358 are resilient and compressible when the syringe assembly 16 is received within the syringe retainer 310.

[0094] refer to Figure 29 and Figure 30 , needle cap 312 and Figures 1A to 16 The needle cap 22 is similar in appearance and function. The needle cap 312 includes a spring rib 360 that engages a spring 68 to hold the spring 68 between the needle cap 312 and the syringe holder 310. The needle cap 312 also includes a housing rib 362 to guide movement of the needle cap 312 relative to the housing 314.

[0095] refer to Figure 31 , Figure 32 , Figure 40 and Figure 41 Box 314 and Figures 1A to 16The housing 26 is similar in appearance and function. As discussed above, housing 314 includes an opening 330 for receiving a clamp 328 of the motor body 302. Housing 314 includes a needle cap clamp 364 that engages a clamping surface 366 of the needle cap 312. The clamping surface 366 of the needle cap 312 is planar, but other suitable shapes and configurations may be used. The needle cap clamp 364 is configured to restrict axial movement of the needle cap 312 relative to housing 314. Housing 314 also includes a motor body rib 368 and an upper housing rib 370 configured to engage corresponding portions of the motor body 302 and the upper housing 320 to aid in the assembly of the device 300. Housing 314 also includes a syringe retainer stop 372 configured to engage multiple portions of the syringe retainer 310 to restrict axial movement of the syringe retainer 310 relative to housing 314. Although Figure 40 Not shown, but locking clip 64 can also be used with drug delivery device 300.

[0096] refer to Figures 33 to 38 Hat 316 is similar to the description above and Figures 1A to 16 The caps 18 shown are similar and functionally similar. The cap 316 includes a protrusion 374 received by a cap opening 376 defined by the pin cap 312, which is relative to... Figures 1A to 16 The elements of the cap 18 are positioned at 90 degrees. The protrusion 374 of the cap 316 is configured to engage the needle cap 312 when it is moved from its pre-use position to its actuated position. For example, when the device 300 is in its storage position and the cap 316 is secured to the lower housing 322, if the device is dropped or impacted to apply force to the needle cap 312, the lever actuation member 308, and / or other components, the protrusion 374 restricts movement of the needle cap 312, preventing any accidental actuation of the device 300. The cap 316 also includes a retaining clip 378 and a rib 380 for engaging the wing 382 of the retainer 318. The retaining clip 378 and the rib 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 RNS 58 when the cap 316 is removed from the lower housing 322. The cap 316 includes a lower outer housing clip 384 for engaging the lower outer housing 322 to secure the cap 316 to the lower outer housing 322. The upper outer housing 320 and lower outer housing 322 are as discussed above and in… Figures 1A to 16 The upper outer casing 46 and the lower outer casing 28 shown are similar and functionally similar. However, the lower outer casing 322 has a cap interface 386 to receive the lower outer casing clip 384 of the cap 316.

[0097] refer to Figure 39The drug delivery device 300 is shown in the injection position. The injection depth of the cannula 56 is determined by the contact between the syringe holder 310 and the housing 314 at point X and the contact between the needle cap 312 and the syringe holder 310 at point Y.

[0098] refer to Figure 39 The drug delivery device 300 includes an audio indicator component 388, which is the same as described above and Figures 1A to 16 The audible indicator component 94 shown is similar in appearance and function. In the same manner as the audible indicator component 94 described above, the audible 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 audible indicator component 388 is configured to engage the rib 390 of the housing 314 when the device 300 is in the injection position, thereby deflecting the audible indicator component 388. When the drug delivery device 300 is switched from the injection position to the post-use position, the audible indicator component 388 disengages from the rib 390 of the housing 314 and contacts the lower outer housing 322 to provide an audible click. However, the distal end 392 of the rib 390 of the housing 314 is tilted rearward toward the upper outer housing 320, engaging with the upper... Figures 1A to 16 Compared to the arrangement of ribs 96 in the discussed housing 26, this advantageously provides a louder, more audible click.

[0099] In one aspect or embodiment, the angle Z of the distal end 392 of the rib 390 of the housing 314 relative to a plane extending perpendicular to the longitudinal axis of the device 300 is greater than 5 degrees. In one aspect or embodiment, the angle Z of the distal end 392 of the rib 390 is greater than 10 degrees. In one aspect or embodiment, the angle Z of the distal end 392 is 25 degrees.

[0100] An element of one disclosed aspect may be combined with one or more elements of other disclosed aspects to form different combinations, all of which are considered to be within the scope of the invention.

[0101] While 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 adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover such deviations from this disclosure that fall within the known or customary practice of the art to which this disclosure pertains and fall within the scope of the appended claims.

Claims

1. A drug delivery device (10), the drug delivery device comprising: Outer shell (26, 28, 46); A syringe assembly (16) comprising a barrel (52), a stopper (54) and a cannula (56), at least a portion of the syringe assembly (16) being positioned within the housing (26, 28, 46); A drive assembly (40) includes a plunger body (80) configured to move a plug (54) within a barrel (52) when the drive assembly (40) is actuated, at least a portion of the drive assembly (40) being located within a housing (26, 28, 46), the plunger body (80) having a pre-use position before movement of the plunger body (80), an injection position in which the plunger body (80) moves the plug (54) within the barrel (52), and a post-use position in which movement of the plunger body (80) has stopped; as well as Audio indicator component (94), which is connected to the plunger body (80). The housing (26, 28, 46) is characterized in that the housing includes a rib (96) extending in the longitudinal direction of the drug delivery device (10), the rib (96) having a distal end (392) adjacent to the distal end of the housing (28), the distal end of the rib being offset by an angle (Z) of 5 to 25 degrees relative to a plane extending perpendicular to the longitudinal axis of the drug delivery device (10), the audio indicator member (94) engaging the rib (96) to deflect the audio indicator member (94) from the unbiased position to the biased position when the plunger body (80) is in the injection position, and the audio indicator member (94) disengaging from the distal end (392) of the rib (96) and contacting the distal portion of the housing (28) to induce an audible indication of the plunger body (80) transitioning from the injection position to the post-use position when the plunger body (80) reaches the post-use position.

2. The drug delivery device (10) according to claim 1, wherein, The audio indicator component (94) has a release position, wherein the audio indicator component (94) is positioned in the bias position when the plunger body (80) is in the injection position, and the audio indicator component (94) is positioned in the release position when the plunger body (80) is in the post-use position.

3. The drug delivery device (10) according to claim 2, wherein, When the plunger body (80) is in the pre-use position, the audio indicator component (94) is positioned in the unbiased position.

4. The drug delivery device (10) according to any one of claims 1-3, wherein, The housing (26, 28, 46) includes a lower housing (28), an upper housing (46), and a box (26) received by the lower housing (28). The lower housing (28) includes an indicator platform (202), and the audio indicator component (94) engages the indicator platform (202) to provide the audio indication.

5. The drug delivery device (10) according to claim 1, wherein, The outer casing (26, 28, 46) includes a lower outer casing (28), an upper outer casing (46), and a housing (26) received by the lower outer casing (28), the housing (26) including the rib (96).

6. The drug delivery device (10) according to any one of claims 1-3 and 5, wherein, The rib (96) includes an inclined surface (204) configured to switch the audio indicator member (94) from the unbiased position to the biased position.

7. The drug delivery device (10) according to claim 5, wherein, The rib (96) extends only a portion of the length of the box body (26).

8. The drug delivery device (10) according to any one of claims 1-3 and 5, wherein, The audio indicator component (94) is integrally formed with the plunger body (80).

9. The drug delivery device (10) according to any one of claims 1-3, 5, further comprising a visual indicator component (220) configured to provide a visual indication of the plunger body (80) transitioning from the injection position to the post-use position.

10. The drug delivery device (10) according to claim 9, wherein, When the plunger body (80) is in the used position, the visual indicator component (220) is visible through the indicator opening (104) defined by the housing (26, 28, 46).

11. The drug delivery device (10) according to claim 10, wherein, The housing (26, 28, 46) includes a lower housing (28) that defines the indicator opening (104).

12. The drug delivery device (10) according to claim 10, wherein, The visual indicator component (220) is integrally formed with the plunger body (80), and the visual indicator component (220) is spaced apart from the audio indicator component (94).

13. The drug delivery device (10) according to any one of claims 1-3, 5, further comprising a syringe holder (24) movable relative to the housing (26, 28, 46), wherein, The audio indicator component (94) is configured to restrict the movement of the syringe holder (24) when the plunger body (80) is in the pre-use position.

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