RU2780524C1 - Autoinjector with a cap - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to medical equipment, namely, to liquid medicine delivery apparatus. Apparatus includes a body (26); a syringe (16) assembly including a cylinder (52), a plug (54), a hollow needle (56), and a rigid needle cover (58) containing at least a section of a hollow needle, wherein at least a section of the syringe assembly is located inside the body; a drive assembly (40), wherein at least a section of the drive assembly is located inside the body; a cap (18) secured to the body, wherein the cap includes an outer section (20) defining the internal space, and the retainer (160) comprises a main part with a remover protrusion (164) configured to remove the rigid needle cover when the outer section of the cap is moved axially away from the body, and a pair of legs (170) continuing radially outward from the main part (162) of the retainer (160), wherein each leg (170) is configured to engage with the edge (172) continuing radially inward from the main part (116) of the outer section (20); and a protective needle barrier (22) with a before-use position, a triggering position, and an after-use position. The outer section accommodates a section of the protective needle barrier, wherein the outer section is configured to prevent the movement of the protective needle barrier from the before-use position to the triggering position.

EFFECT: ensured medicine delivery by means of the apparatus.

28 cl, 85 dwg

Description

BACKGROUND OF THE INVENTION

The field of technology to which the invention belongs

[0001] The present invention relates generally to a drug delivery device and in particular to an autoinjector.

Description of the prior art

[0002] In order to enable the introduction of untrained personnel and self-administration of drug solutions and other liquid drugs, various types of automatic injection devices have been developed. In general, these devices include a container that is pre-filled with liquid medication and some type of automatic needle injection mechanism that can be triggered by the user. Many of these devices, such as autoinjectors, are designed so that a container, such as a pre-filled syringe, is inserted into the device during assembly of the device. In addition to automatically actuating the needle injection mechanism, many drug delivery devices also automatically guard the needle after use of the device to prevent any inadvertent contact with the needle.

SUMMARY OF THE INVENTION

[0003] In one aspect, the drug delivery device includes a body, a syringe assembly including a barrel, a stopper, a cannula, and a rigid needle sheath accommodating at least a portion of the cannula, wherein at least a portion the syringe assembly is located inside the body, the drive unit is configured to move the plug inside the cylinder, when the drive unit is actuated, moreover, at least a section of the drive unit is located inside the body, a cap fixed to the body, and the cap includes an outer section, limiting the internal space, and a latch containing the main part with the protrusion of the stripper, made with the possibility of removing the hard needle cover, with axial movement of the outer section of the cap from the body, and the needle guard, having a position before use, in which the hollow needle is located inside the needle guard , the actuation position at which the drive assembly is actuated, and the position after use niya, in which the hollow needle is located inside the protective guard of the needle. The outer portion accommodates a needle guard portion, wherein the outer portion is configured to prevent the needle guard from moving from the pre-use position to the firing position.

[0004] The outer portion includes a protrusion that fits into a cap hole formed in the needle guard, wherein the protrusion of the outer portion is configured to engage with the needle guard when the needle guard is moved from a pre-use position to a firing position.

[0005] The latch portion can fit within the inner space of the outer portion, wherein the latch is lockable to the outer portion and allows axial movement relative to it. The outer portion may include a locking protrusion fitting into a latch hole formed in the latch body, wherein the locking lug is disengaged from the latch body when the outer portion is secured to the body, and the locking lug of the outer portion is configured to engage with the latch when axial movement of the outer section from the housing and axial movement of the outer section relative to the latch. The latch may include a pair of tabs extending radially outward from the body of the latch, with each tab being configured to engage a rib extending radially inward from the body of the outer portion.

[0006] The locking protrusion may extend radially outward through the lock hole. The fixing protrusion of the outer portion can be fixed to the body of the cap by means of an elongated console, while the fixing protrusion is able to move radially inward due to the elongated console. The retainer may include a flange engaged with the outer portion when the outer portion is secured to the body. The retainer flange can be separated from the outer section by axial movement of the outer section from the housing. The surface of the protrusion of the stripper may be flat, and the corresponding surface of the hard needle case may be flat.

[0007] The main body of the latch may have a first end and a second end located opposite the first end, while the protrusion of the stripper extends radially inward from the body of the latch by means of the stripper arm, and the arm of the stripper extends radially inward and in a direction extending from the second end of the main body to the first end of the main body. The protrusion of the puller is able to move relative to the main part of the latch thanks to the puller console.

[0008] The device may further include a syringe holder disposed within the housing, wherein the syringe holder accommodates the syringe assembly and the syringe holder is movable relative to the housing. The syringe holder can be disengaged from the drive assembly when the outer portion is secured to the body, with the syringe holder engaged with the drive assembly, while the outer portion moves axially away from the body.

[0009] A puller protrusion surface may be configured to engage with a corresponding surface of the hard needle boot to remove the hard needle boot when the outer portion of the cap is moved axially away from the housing, the puller protrusion surface being disengaged from the corresponding surface of the hard needle boot when the outer portion attached to the hull. The protrusion may be retractable from the cap hole before the surface of the stripper protrusion engages the corresponding surface of the rigid needle sheath upon axial movement of the outer portion away from the housing.

[0010] The outer portion may include one of a locking lug and the locking recess, and the housing may include another of the locking lug and the locking recess, wherein the locking lug fits into the locking recess to secure the outer portion to the housing , and moreover, the locking protrusion is separated from the locking recess before the surface of the protrusion of the stripper engages with the corresponding surface of the rigid needle cover, with axial movement of the outer section from the body.

[0011] The device may include one or more of the following features individually or in all technically possible combinations:

the drug delivery device may comprise: a housing; a syringe assembly comprising a barrel, a stopper, a cannula, and a rigid needle sheath accommodating at least a portion of the cannula, with at least a portion of the syringe assembly located within the housing; a drive assembly configured to move the plug within the cylinder when the drive assembly is actuated, wherein at least a portion of the drive assembly is disposed within the housing; a cap fixed to the body, wherein the cap contains an outer section that limits the internal space, and a latch containing a main part with a puller protrusion, the puller protrusion being capable of removing a hard needle cover, with axial movement of the outer cap section from the body, and a needle guard having a position before use in which the hollow needle is located inside the needle guard, an actuation position in which the drive assembly is actuated, and a position after use in which the hollow needle is located inside the needle guard, and the outer portion accommodates the portion of the needle guard, the outer the section is configured to prevent movement of the needle guard from the position before use to the position of operation;

the outer portion may include a protrusion that fits into a cap hole formed in the needle guard, wherein the protrusion of the outer portion is configured to engage with the needle guard when the needle guard is moved from a pre-use position to a firing position;

- the latch section can fit in the inner space of the outer section of the cap, and at the same time the latch is fixed to the outer section and allows axial movement relative to it.

- the outer section may contain a locking protrusion that fits into the latch hole formed in the main part of the latch, while the locking protrusion is disconnected from the main part of the latch when the outer section is fixed to the body, and the locking protrusion of the outer section is made with the possibility of engaging with the latch, when axially moving the outer section away from the housing and during axial movement of the outer section relative to the latch;

the retainer may comprise a pair of tabs extending radially outward from the main body of the retainer, each tab being configured to engage a rib extending radially inward from the main body of the outer portion;

- the locking protrusion can extend radially outward through the hole of the lock;

- the locking protrusion of the outer section can be fixed to the main part of the outer section by means of an elongated console, while the locking protrusion is able to move radially inward due to the elongated console;

- the latch may include a flange engaged with the outer section, when the outer section is fixed to the body;

- the retainer flange can be separated from the outer section, with axial movement of the outer section from the body;

- the surface of the protrusion of the stripper may be flat, while the corresponding surface of the rigid needle cover is flat;

- the main body of the latch may include a first end and a second end opposite the first end, a puller protrusion extending radially inward from the main part of the latch on the arm of the puller, while the arm of the puller continues radially inward and in a direction extending from the second end of the main part to the first end of the main part. The protrusion of the puller is able to move relative to the main part;

- the protrusion of the puller is able to move relative to the main part of the latch due to the console of the puller;

- the syringe holder can be located inside the body, while the syringe holder accommodates the syringe assembly, the syringe holder is movable relative to the body, and the syringe holder is disengaged from the drive unit when the outer section is fixed to the body, and the syringe holder is engaged with the drive unit, during axial movement of the outer section from the housing;

- the surface of the protrusion of the stripper can be configured to engage with the corresponding surface of the hard needle cover to remove the hard needle cover, when the outer section of the cap is axially moved away from the body, while the surface of the protrusion of the stripper is disengaged from the corresponding surface of the rigid needle cover, when the outer section is fixed to corps;

- the outer section may contain one of a locking lug and a locking recess, and the body contains another element of a locking lug and a locking recess, while the locking lug fits into the locking recess to secure the outer section to the body, and wherein the locking lug is separated from locking recess before the surface of the protrusion of the stripper engages with the corresponding surface of the rigid needle cover, with axial movement of the outer section from the body;

the drug delivery device may comprise: a housing; a syringe assembly comprising a barrel, a stopper, a cannula, and a rigid needle sheath accommodating at least a portion of the cannula, with at least a portion of the syringe assembly located within the housing; a drive assembly configured to move the plug within the cylinder when the drive assembly is actuated, wherein at least a portion of the drive assembly is disposed within the housing; and a cap fixed to the body, wherein the cap comprises an outer portion defining an internal space, and a retainer comprising a main body with a stripper protrusion, wherein the surface of the stripper protrusion is configured to engage with a corresponding surface of the hard needle sheath to remove the hard needle sheath, at axial moving the outer portion of the cap away from the body, and the surface of the protrusion of the remover is separated from the corresponding surface of the hard needle cover, when the outer portion is fixed to the body;

the drug delivery device may comprise: a housing; a syringe assembly comprising a barrel, a stopper, a cannula, and a rigid needle sheath accommodating at least a portion of the cannula, with at least a portion of the syringe assembly located within the housing; a drive assembly configured to move the plug within the cylinder when the drive assembly is actuated, wherein at least a portion of the drive assembly is disposed within the housing; and a cap fixed to the body, wherein the cap comprises an outer section that delimits the inner space, and a latch containing a main part with a protrusion of the puller, moreover, the latch section fits in the inner space of the outer section of the cap, and the latch is fixed to the outer section and allows axial movement relative to it, and the outer section contains a locking protrusion that fits into the hole of the latch formed in the main part of the latch, and the locking lug is disconnected from the main part of the latch, when the outer section is fixed to the body, the locking protrusion of the outer section is made with the possibility of engaging with the latch, during axial movement the outer section from the body and with axial movement of the outer section relative to the latch;

the drug delivery device may comprise: a housing; a syringe assembly comprising a barrel, a stopper, a cannula, and a rigid needle sheath accommodating at least a portion of the cannula, with at least a portion of the syringe assembly located within the housing; a drive assembly configured to move the plug within the cylinder when the drive assembly is actuated, wherein at least a portion of the drive assembly is disposed within the housing; a cap attached to the body, the cap contains an outer section that defines the inner space, and a latch containing the main part with the protrusion of the stripper; and a syringe holder located within the housing, the syringe holder accommodating the syringe assembly, the syringe holder being movable with respect to the housing, the syringe holder being disengaged from the drive assembly when the outer portion is secured to the housing, and the syringe holder being engaged with the drive assembly when axial movement of the outer section from the housing.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The above and other features and advantages of the invention and the method of achieving them will become apparent, and the invention itself will be clearer from the following description of the embodiments of the invention, when studied with reference to the accompanying drawings, in which:

[0013] FIG. 1A is a perspective view of a drug delivery device in accordance with one aspect of the present application, showing the storage position of the device.

[0014] FIG. 1B is a perspective view of the drug delivery device shown in FIG. 1 representing the position of the device before use.

[0015] FIG. 2A is a sectional view of the drug delivery device shown in FIG. 1 representing the storage position of the device.

[0016] FIG. 2B is a sectional view of the drug delivery device shown in FIG. 1 representing the position of the device before use.

[0017] FIG. 3 is a perspective view of the drug delivery device shown in FIG. 1 representing the actuation position of the device.

[0018] FIG. 4 is a sectional view of the drug delivery device shown in FIG. 1 representing the actuation position of the device.

[0019] FIG. 5 is a perspective view of the drug delivery device shown in FIG. 1 representing the injection position of the device.

[0020] FIG. 6 is a sectional view of the drug delivery device shown in FIG. 1 representing the injection position of the device.

[0021] FIG. 7 is a perspective view of the drug delivery device shown in FIG. 1 representing the position of the device after use.

[0022] FIG. 8 is a sectional view of the drug delivery device shown in FIG. 1 representing the position of the device after use.

[0023] FIG. 9 is a perspective view of the drug delivery device shown in FIG. 1 representing a fastening bracket.

[0024] FIG. 10 is an exploded perspective view of the drug delivery device shown in FIG. 1 representing a fastening bracket.

[0025] FIG. 11A is a partial sectional view of the drug delivery device shown in FIG. 1 showing the locking arm of the cassette part.

[0026] FIG. 11B is an enlarged sectional view of the portion indicated in FIG. 11A.

[0027] FIG. 12 is a sectional view of the drug delivery device shown in FIG. 1 representing the position after using the device until complete drug delivery.

[0028] FIG. 13A is a partial sectional view of the drug delivery device shown in FIG. 1 representing the cap of the device.

[0029] FIG. 13B is an enlarged sectional view of the portion indicated in FIG. 13A.

[0030] FIG. 14 is a partial sectional view of the drug delivery device shown in FIG. 1 showing the lever trigger in the device in the storage position.

[0031] FIG. 15A is a partial sectional view of the drug delivery device shown in FIG. 1 representing the storage position of the device and the movement of the needle guard.

[0032] FIG. 15B is an enlarged sectional view of the portion indicated in FIG. 15A.

[0033] FIG. 15C is an enlarged sectional view of the portion indicated in FIG. 15A.

[0034] FIG. 16 is a perspective view of a lever trigger according to one aspect of the present application.

[0035] FIG. 17A is a sectional view of the drug delivery device shown in FIG. 1 representing the storage position of the device.

[0036] FIG. 17B is an enlarged sectional view of the portion indicated in FIG. 17A.

[0037] FIG. 17C is an enlarged sectional view of the portion indicated in FIG. 17A.

[0038] FIG. 17D is an enlarged sectional view of the portion indicated in FIG. 17A.

[0039] FIG. 17E is an enlarged sectional view of the portion indicated in FIG. 17A.

[0040] FIG. 17F is an enlarged sectional view of the portion indicated in FIG. 17A.

[0041] FIG. 18A is a partial sectional view of the drug delivery device shown in FIG. 1 representing the initial cap removal of the device.

[0042] FIG. 18B is an enlarged sectional view of the portion indicated in FIG. 18A.

[0043] FIG. 18C is an enlarged sectional view of the portion indicated in FIG. 18A.

[0044] FIG. 18D is an enlarged sectional view of the portion indicated in FIG. 18A.

[0045] FIG. 18E is an enlarged sectional view of the portion indicated in FIG. 18A.

[0046] FIG. 18F is an enlarged sectional view of the portion indicated in FIG. 18A.

[0047] FIG. 19A is a partial sectional view of the drug delivery device shown in FIG. 1 representing the removal of the device cap.

[0048] FIG. 19B is an enlarged sectional view of the portion indicated in FIG. 19A.

[0049] FIG. 19C is an enlarged sectional view of the portion indicated in FIG. 19A.

[0050] FIG. 19D is an enlarged sectional view of the portion indicated in FIG. 19A.

[0051] FIG. 19E is an enlarged sectional view of the portion indicated in FIG. 19A.

[0052] FIG. 19F is an enlarged sectional view of the portion indicated in FIG. 19A.

[0053] FIG. 20A is a partial sectional view of the drug delivery device shown in FIG. 1 representing the removal of the device cap.

[0054] FIG. 20B is an enlarged sectional view of the portion indicated in FIG. 20A.

[0055] FIG. 20C is an enlarged sectional view of the portion indicated in FIG. 20A.

[0056] FIG. 20D is an enlarged sectional view of the portion indicated in FIG. 20A.

[0057] FIG. 20E is an enlarged sectional view of the portion indicated in FIG. 20A.

[0058] FIG. 20F is an enlarged sectional view of the portion indicated in FIG. 20A.

[0059] FIG. 21A is a partial sectional view of the drug delivery device shown in FIG. 1 representing removal of the device.

[0060] FIG. 21B is an enlarged sectional view of the portion indicated in FIG. 21A.

[0061] FIG. 21C is an enlarged sectional view of the portion indicated in FIG. 21A.

[0062] FIG. 21D is an enlarged sectional view of the portion indicated in FIG. 21A.

[0063] FIG. 21E is an enlarged sectional view of the portion indicated in FIG. 21A.

[0064] FIG. 21F is an enlarged sectional view of the portion indicated in FIG. 21A.

[0065] FIG. 22A is a partial sectional view of the drug delivery device shown in FIG. 1 representing the removal of the device cap.

[0066] FIG. 22B is an enlarged sectional view of the portion indicated in FIG. 22A.

[0067] FIG. 22C is an enlarged sectional view of the portion indicated in FIG. 22A.

[0068] FIG. 22D is an enlarged sectional view of the portion indicated in FIG. 22A.

[0069] FIG. 22E is an enlarged sectional view of the portion indicated in FIG. 22A.

[0070] FIG. 22F is an enlarged sectional view of the portion indicated in FIG. 22A.

[0071] FIG. 23 is a perspective view of a cap, retainer, and rigid needle sheath in accordance with one aspect of the present application.

[0072] FIG. 24 is a perspective view of a latch in accordance with one aspect of the present application.

[0073] FIG. 25 is a perspective view of a drug delivery device according to a further aspect of the present application, showing the storage position of the device.

[0074] FIG. 26 is a sectional view taken along line 26-26 of FIG. 25.

[0075] FIG. 27 is a top perspective view of the drive rail of the drug delivery device shown in FIG. 25.

[0076] FIG. 28 is a bottom perspective view of the drive rail shown in FIG. 27.

[0077] FIG. 29 is a front perspective view of the plunger portion of the drug delivery device shown in FIG. 25.

[0078] FIG. 30 is a rear perspective view of the plunger portion shown in FIG. 29.

[0079] FIG. 31 is a front perspective view of a portion of the plunger rod of the drug delivery device shown in FIG. 25.

[0080] FIG. 32 is a rear perspective view of a portion of the plunger rod shown in FIG. 31.

[0081] FIG. 33 is a top perspective view of the lever trigger of the drug delivery device shown in FIG. 25.

[0082] FIG. 34 is a bottom perspective view of the lever trigger of the drug delivery device shown in FIG. 33.

[0083] FIG. 35 is a front perspective view of the syringe holder of the drug delivery device shown in FIG. 25.

[0084] FIG. 36 is a rear perspective view of the syringe holder of the drug delivery device shown in FIG. 35.

[0085] FIG. 37 is a front perspective view of the needle guard of the drug delivery device shown in FIG. 25.

[0086] FIG. 38 is a rear perspective view of the needle guard of the drug delivery device shown in FIG. 37.

[0087] FIG. 39 is a top perspective view of the cassette portion of the drug delivery device shown in FIG. 25.

[0088] FIG. 40 is a bottom perspective view of the cassette portion of the drug delivery device shown in FIG. 39.

[0089] FIG. 41 is a top perspective view of the cap of the drug delivery device shown in FIG. 25.

[0090] FIG. 42 is a sectional view taken along line 42-42 in FIG. 41.

[0091] FIG. 43 is a perspective view of the fixture of the drug delivery device shown in FIG. 25.

[0092] FIG. 44 is a sectional view of the upper body frame of the drug delivery device shown in FIG. 25.

[0093] FIG. 45 is a perspective view of the lower body frame of the drug delivery device shown in FIG. 25.

[0094] FIG. 46 is a sectional view taken along line 46-46 in FIG. 45.

[0095] FIG. 47 is a sectional view of the drug delivery device shown in FIG. 25 representing the injection position of the device.

[0096] FIG. 48 is a partial sectional view of the drug delivery system shown in FIG. 25.

[0097] FIG. 49 is a sectional view of the drug delivery system shown in FIG. 25.

[0098] The corresponding symbols indicate the corresponding parts in several views. The examples provided in this application illustrate exemplary aspects of the invention and such examples should not be construed as limiting the scope of the invention in any way.

DETAILED DESCRIPTION

[0099] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. However, various other modifications, equivalents, variations and alternatives will be readily apparent to those skilled in the art. All such modifications, variations, equivalents and alternatives are intended to be within the spirit and scope of the present invention.

[00100] For the purposes of the following description, definitions of "top", "bottom", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "longitudinal ” and derivatives from them should refer to the invention as it is oriented in the figures of the drawings. However, it should be understood that the invention may allow various alternatives, in the absence of express indications to the contrary content. It should also be understood that the specific devices depicted in the accompanying 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 in this application should not be considered limiting.

[00101] As shown in FIG. 1A-10, a drug delivery device 10 in accordance with one aspect of the present invention includes a first subassembly 12, a second subassembly 14, and a syringe assembly 16. The first subassembly 12 includes a cap 18 containing an outer portion 20, a needle guard 22, a syringe holder 24, a cartridge portion 26, and a lower housing frame 28. The second subassembly 14 includes a drive assembly 40, a drive guide 42, a lever trigger 44, and a top body frame 46. Syringe assembly 16 fits into syringe holder 24 and includes barrel 52, plug 54, cannula 56, and rigid needle sheath (RNS) 58. Although RNS is used, other suitable needle sheath designs may be used. The lower case frame 28, the cartridge portion 26, and the upper case frame 46 typically form a case to accommodate the various components of the device 10, although other suitable case designs may be used. As detailed below, the first subassembly 12 and the second subassembly 14 are attached to each other during assembly by a retaining clip 64, although other suitable designs may be used. The drug delivery device 10 may be an auto-injector, although the features described herein may be included in other suitable drug delivery devices.

[00102] The drug delivery device 10 is configured to automatically deliver a dose of medication to a patient from the syringe assembly 16 when the device 10 is actuated. of the syringe assembly 16, move the syringe assembly 16 so that the cannula 56 pierces the patient's skin, and move the stopper 54 inside the barrel 52 of the syringe assembly 16 to deliver the medication contained within the barrel 52. The drug delivery device 10 has a storage position (FIG. 1A and 2A), pre-use position (FIGS. 1B and 2B), actuation position (FIGS. 3 and 4), injection position (FIGS. 5 and 6), and post-use position (FIGS. 7 and 8). As detailed below, the needle guard 22 is configured to obstruct the cannula 56 of the syringe assembly 16 from the patient when the device 10 is in the pre-use and post-use positions. Specifically, the needle guard 22 is movable between a pre-use position, an actuation position, and an after-use position, with the spring 68 pressing the needle guard 22 toward the pre-use position and the post-use position. The spring 68 is positioned between the needle guard 22 and the syringe holder 24, although other suitable designs may be used. The trigger lever 44 is movable between a locked position in which movement of the drive unit 40 is not allowed and a released position in which movement of the drive unit 40 is allowed. In particular, the lever trigger 44 is rotatable about the axis of rotation 70 between a locked position and a released position. When lever trigger 44 is in the locked position, lever trigger 44 is engaged with drive rail 42 and drive assembly 40 to prevent movement of drive assembly 40. When the lever trigger 44 is in the released position, the lever trigger 44 is disengaged from the drive guide 42, thereby allowing movement of the drive assembly 40 toward the syringe 16 assembly. The axis of rotation 70 of the lever trigger 44 extends perpendicular to the longitudinal axis of the device 10, although other suitable designs may be used.

[00103] As also shown in FIG. 1-10, the actuator assembly 40 includes a plunger portion 80 having a plunger rod portion 82 and an actuator 84. The actuator 84 is a compression spring housed within an actuator bore 86 formed in the plunger portion 80, although other suitable actuators may be used. elements, including, but not limited to, compressed gas, electric motor, hydraulic pressure, other types of springs, etc. The drive member 84 is engaged with the plunger portion 80 and the actuator guide 42 and urges the plunger portion 80 in a direction extending from the second subassembly 14 to the first subassembly 12. The plunger portion 80 defines a lever opening 88 which receives the lever trigger 44 and defines the axle 70 rotation of the lever trigger 44. The lever trigger 44 prevents movement of the plunger portion 80 when the lever trigger 44 is in the locked position by engaging the lever trigger 44 with the drive guide 42. Upon rotation of the lever trigger 44 from the locked position to the released position, the lever trigger 44 disengages from the actuator guide 42 and thereby allows the actuator 84 to move the plunger portion 80 and plunger rod portion 82 towards the first subassembly 12. Section 82 The plunger rod and the drive element 84 are spaced apart and parallel to each other and continue in the longitudinal direction of the device 10.

[00104] The drive assembly 40 further includes a spring guide 90 secured to the upper body frame 46 and received within the drive bore 86 of the plunger portion 80. The drive member 84 is received in the spring guide 90 such that the drive member 84 is located between the plunger part 80 and the spring guide 90. The drive assembly 40 includes a plunger rod sheath 92 that accommodates the plunger rod portion 82 of the plunger portion 80. The plunger rod sheath 92 is configured to direct the insertion of the plunger rod portion 82 into the barrel 52 of the syringe 16 assembly and engage the plug 54 of the syringe 16 assembly, to dispense medication from the barrel 52 of the syringe 16 assembly. The plunger stem shell 92 and plunger stem portion 82 may be integrally formed or formed as separate components.

[00105] The plunger portion 80 of the actuator assembly 40 also includes an audible indicator element 94 configured to provide an audible indication to the user when the device 10 enters a post-use position. As detailed below, the sonic indicator 94 is configured to engage one or more ribs 96 of the cassette portion 26 when the device 10 is in the injection position, thereby bending the sonic indicator 94. When the drug delivery device 10 moves from the position injection into position after use, the sonic indicator 94 disengages from the rib(s) 96 of the cassette portion 26 and comes into contact with the lower body frame 28 to provide an audible click, although the sonic indicator 94 may also be in contact with other suitable areas of the device 10, to provide an audible indicator.

[00106] As shown in FIG. 1A-2B, in the storage position, the cap 18 is secured to the lower body frame 28 and is engaged with the needle guard 22. Movement of the needle guard 22 from the pre-use position to the actuation position results in engagement between the needle guard 22 and the lever trigger 44, causing the drive assembly 40 to be actuated. After removal of the cap 18 by gripping the outer portion 20, the needle guard 22 can be moved from the pre-use position to the firing position by pressing the needle guard 22 against the patient's skin surface and axially pushing the device 10 against the skin surface. As detailed below, engagement between cap 18 and needle guard 22 prevents movement of needle guard 22 into engagement with lever trigger 44. Accordingly, removal of cap 18 from device 10 allows actuation of device 10. As detailed below, removal of cap 18 from device 10 as shown in FIG. 1B and 2B also removes the RNS 58 from the syringe barrel 52, thereby opening the cannula 56, which still fits inside the needle guard 22 in the pre-use position 10.

[00107] As shown in FIG. 3 and 4, in the triggered position, the cap 18 is removed and the needle guard 22 is placed in the triggered position by being brought into contact with the patient's skin surface, which moves the needle guard 22 further inside the device 10 towards the second subassembly 14. When the guard 22 the needle has moved a sufficient distance within the device 10, the needle guard portion 22 engages the lever trigger 44, which rotates the lever trigger 44 about the axis of rotation 70 from the locked position to the released position.

[00108] As shown in FIG. 5 and 6, in the injection position, the lever trigger 44 is in the released position, which allows the plunger portion 80 of the drive assembly 40 to move toward the first subassembly 12 such that the plunger portion 80 or plunger shaft sheath 92 engages the stopper of the syringe 16 in collection. The initial engagement of the drive assembly 40 with the syringe assembly 16 moves the syringe assembly 16 and the syringe holder 24 within the device 10 and relative to the cartridge portion 26 until the syringe holder 24 abuts against the stopper 102 formed by the cartridge portion 26. During the initial movement of the syringe 16 into assembly and syringe holder 24, in a state with the needle guard 22 pressed against the patient's skin surface, the cannula 56 of the syringe assembly 16 extends beyond the needle guard 22 and pierces the patient's skin surface. Additional movement of plunger portion 80, which is driven by drive member 84, moves plug 54 relative to barrel 52 of syringe assembly 16 to dispense medication from barrel 52 of syringe assembly 16 through cannula 56 and into the patient. The plunger portion 80 will continue to move until the plug 54 reaches the bottom of the barrel 52 of the syringe 16 assembly. When the plug 54 hits the bottom, or just before the plug 54 hits the bottom, the buzzer 94 will disengage from the fin(s) 96 of the cassette 26 and come into contact with the lower body frame 28 at approximately the same time to provide sound indication to the patient that the dose of the drug has been delivered. In addition to an audible indication, the drug delivery device 10 provides one or more visual indicators to alert the patient to the status of the device 10. In particular, the cassette portion 26 may be formed from a transparent material to allow visual confirmation of the movement of the plug 54 and/or other visual indication. an indicator provided by the drive assembly 40, the syringe holder 24, and/or the syringe 16 assembly. The lower body frame 28 also defines an indicator hole 104 which provides a visual indication that the plunger portion 80 is in its final position and a dose of medication has been delivered. Visual indicators may use contrasting colors, symbols, patterns, or any other suitable visual cues to indicate various device states.

[00109] As shown in FIG. 7, 8, 11A, 11B and 12, in the post-use position, the needle guard 22 extends to the post-use position to shield the cannula 56 when the needle guard 22 is retracted from the patient's skin surface. As shown more clearly in FIG. 11B, the cartridge portion 26 includes at least one locking arm 106 and the needle guard 22 includes at least one locking lug 108, although other suitable configurations may be used. The locking arm 106 of the cartridge portion 26 engages the locking lug 108 of the needle guard 22 to prevent any further use of the device 10 and opening of the cannula 56 of the syringe 16 assembly. During the transition of the device 10 from the injection position to the post-use position, the locking arm 106 of the cartridge portion 26 is deflected to allow the locking lug 108 of the needle guard 22 to pass past the cartridge portion 26, while the locking arm 106 returns to its original position to block the movement of the needle guard. guards 22 needles back into position before use and actuation. In the position prior to use of the needle guard 22, a portion of the needle guard 22 is engaged with the guard stop 110 of the syringe holder 24 to limit axial movement of the needle guard 22 in a direction extending from the second subassembly 14 to the first subassembly 12. After using the device 10, the syringe holder 24 moves within the cartridge portion 26 relative to the needle guard 22 to allow the needle guard 22 to extend into a post-use position when the patient withdraws the needle guard 22 from the skin surface. As shown in FIG. 12, the needle guard 22 will move to the post-use position when the needle guard 22 is retracted from the patient's skin surface, regardless of the position of the plug 54 within the barrel 52 of the syringe 16 assembly. Accordingly, if the patient withdraws the needle guard 22 from the skin surface after only a portion of the dose of medication has been delivered, the needle guard 22 will still move to the post-use position and prevent further use of the device 10.

[00110] As shown in FIG. 1A, 1B and 13A-15C and described above, the engagement between the cap 18 and the needle guard 22 prevents the needle guard 22 from moving into engagement with the lever trigger 44. The cannula 56 is positioned within the needle guard 22 when the needle guard 22 is in position. in position before use and position after use. The needle guard 22 is configured to actuate the drive assembly 40 when the needle guard 22 is in the actuation position. Removal of the cap 18 from the device 10 allows the device 10 to operate. More specifically, in one aspect of the present application, the outer portion 20 of the cap 18 includes a body 116 defining an interior space 118 that accommodates a portion of the needle guard 22 when the device 10 is in position storage, with the outer section 20 fixed to the lower body frame 28. The outer section 20 of the cap 18 is fixed to the lower case frame 28 by means of a locking lug 112, which fits into the locking recess 114 formed by the main part 116 of the outer section 20 of the cap 18. The outer section 20 also includes a gripping surface 130 to facilitate gripping and removing the outer portion 20 of the cap 18 from the lower body frame 28.

[00111] The outer portion 20 includes a pair of protrusions 120 received by cap holes 122 formed in the needle guard 22, although one or more protrusions 120 and one or more cap holes 122 may be used. The protrusions 120 of the outer portion 20 are configured to engage with the needle guard 22 when the needle guard 22 is moved from the pre-use position to the firing position. For example, when the device 10 is in the storage position, with the outer portion 20 secured to the lower housing frame 28, if the device 10 is dropped or subjected to a forceful impact against the needle guard 22, the lever trigger 44 and/or other component, the protrusions 120 of the outer section 20 limit the movement of the needle guard 22, which prevents any unintentional actuation of the device 10. The protrusions 120 of the outer section 20 are radially movable due to the elongated consoles 124 of the outer section 20. As shown in FIG. 13B, for example, engagement between the elongated arms 124 and the lower body frame 28 blocks the projections 120 from radially outward movement. body frame 28, blocks the radial outward movement of the protrusions 120 while the outer section 20 is mounted on the lower body frame 28. The protrusions 120 are designed to be removed from the holes 122 for the cap of the needle guard 22, with the axial movement of the outer section 20. In particular, the protrusions 120 made with the possibility of engagement with the protective fence 22 of the needle and deviation radially outward, with axial movement of the outer section 20 of the cap 18.

[00112] As shown in FIG. 13B, the projections 120 each define a first cam surface 126 and the needle guard 22 defines a second cam surface 128, the first cam surface 126 being configured to engage with the second cam surface 128 to deflect each projection 120 radially outward, thereby allowing separating the outer portion 20 from the needle guard 22. The first and second cam surfaces 126,128 are mating ramps, although other suitable designs may be used.

[00113] As shown in FIG. 14-16, the needle guard 22 blocks movement or rotation of the lever trigger 44 from the locked position to the released position when the needle guard 22 is in the pre-use position. The lever trigger 44 includes a main body 132 having a restrictive surface 134 configured to engage the needle guard 22 and limit the rotation of the lever trigger 44 when the needle guard 22 is in position prior to use. When the device 10 is in the storage position, if the device 10 is dropped or subjected to impact with the application of force to the lever trigger 44, the lever trigger 44 is blocked from full rotation, enabling the operation of the drive unit 40, due to engagement between the limiting surface 134 of the lever trigger 44 and protective fence 22 needles. The restrictive surface 134 is spaced from the needle guard 22 to form a gap 136 when the device 10 is in the storage and pre-use positions to prevent any increase in friction when the needle guard 22 is moved while preventing inadvertent actuation of the device 10.

[00114] The lever trigger body 132 also has a mounting surface 138 configured to engage with a lock pin (not shown) received in a pin hole 140 formed in the drive guide 42. Prior to assembly, the second subassembly 14 may include a locking pin that extends through the finger hole 140 that prevents the lever trigger 44 from rotating and inadvertently actuating the drive assembly 40 during assembly of the device 10. The main body 132 of the lever trigger also includes a surface 142 the needle guard contact surface 144 of the drive guide contact and defines the recessed portion 146. The needle guard contact surface 142 on the lever trigger 44 engages the lever contact portion 148 on the needle guard 22 when the needle guard 22 move to the actuation position and thereby rotate the trigger lever 44 from the locked position to the released position. The drive guide contact surface 144 on the lever trigger 44 is engaged with the locking surface 150 of the drive guide 42 when the lever trigger 44 is in the locked position, which prevents movement of the plunger portion 80. When the lever trigger 44 rotates from the locked to the released position position, the actuator guide contact surface 144 disengages with the locking surface 150 of the actuator guide 42, which allows the actuator 84 to move the plunger portion 80.

[00115] The recessed portion 146 of the lever trigger 44 provides clearance for the lever contact portion 148 on the needle guard 22 to allow the lever trigger 44 to rotate from the locked position to the released position. The position of the limiting surface 134 of the lever trigger 44 overlaps in the axial direction of the device 10 with the position of the lever contact portion 148 on the needle guard 22 when the needle guard 22 is in the pre-use position and until the needle guard 22 is fully moved to the firing position which prevents the device 10 from being unintentionally actuated as described above. When the needle guard 22 is fully moved to the firing position, the lever contact portion 148 on the needle guard 22 no longer overlaps with the position of the lever trigger stop surface 134 and instead overlaps with the position of the recessed portion 146 in a direction extending in the axial direction device 10 and engages the needle guard contact surface 142 to rotate the trigger 44 as described above. The restrictive surface 134 of the lever trigger 44 is flat and is configured to engage a corresponding flat surface on the underside of the needle guard contact surface 142 when the needle guard 22 is in position prior to use, although other suitable configurations may be used.

[00116] As shown in FIG. 17A-24, in accordance with one aspect of the present application, the device further includes a retainer 160 comprising a body 162 with a stripper protrusion 164 configured to remove the RNS 58 upon axial movement of the outer portion 20 of the cap 18 away from the lower body frame 28. of the latch 160 is received in the inner space 118 of the outer portion 20. The outer portion 20 includes a latch protrusion 166 fitting into a latch hole 168 formed in the body 162 of the latch 160 to latch the latch 160 to the outer portion 20. As detailed below, the latch lug 166 is configured to engage latch 160 as outer portion 20 moves axially away from lower body frame 28. As shown more clearly in FIG. 23 and 24, the latch 160 further includes a pair of tabs 170 extending radially outward from the body 162 of the latch 160, each tab 170 being configured to engage with a rib 172 extending radially inward from the body 116 of the outer portion 20. The tabs 170 prevent rocking between outer portion 20 and latch 160 after outer portion 20, latch 160 and RNS 58 have been removed.

[00117] As shown in FIG. 17C, the locking lug 166 of the outer portion 20 is disengaged from the latch 160 when the outer portion 20 is secured to the lower housing frame 28 when the device 10 is in the storage position. As shown in FIG. 20C, 21C, and 22C, the locking lug 166 of the outer portion 20 is disengaged from the latch 160 when the outer portion 20 is secured to the lower body frame 28. The locking lug 166 of the outer portion 20 is secured to the body 116 of the outer portion 20 via an elongated console 174. The locking lug 166 able to move radially inward due to the elongated arm 174. The flexibility of the elongated arm 174 facilitates the assembly of the latch 160 with the outer portion 20, as it allows the locking lug 166 to deflect radially inward, when the latch lug 166 engages with the latch 160, until the latch lug 166 fits into hole 168 of the latch. The latch 160 includes a flange 176 that engages with the outer portion 20 when the outer portion 20 is secured to the lower body frame 28. The flange 176 of the latch 160 separates from the outer portion 20 when the outer portion 20 moves axially away from the lower body frame 28.

[00118] As shown in FIG. 17E, the body 162 of the latch 160 is cylindrical and has a first end 178 and a second end 180 opposite the first end 178. The stripper protrusion 164 extends radially inwardly from the body 162 of the latch 160 due to the stripper arm 182. The stripper arm 182 extends radially inwardly and in a direction extending from the second end 180 of the main body 162 to the first end 178 of the main body 162, which allows the retainer 160 to be positioned over the RNS 58 and the syringe 16 assembly during installation of the outer portion 20 and the retainer 160 onto the device. 10. The puller protrusion 164 is movable relative to the main body 162 of the latch 160 due to the puller arm 182. In particular, the stripper lug 164 can move radially outward during installation of the retainer 160 on the RNS 58 and move radially inward during the removal of the outer portion 20 and the latch 160. The puller lug 164 has a surface 184 that is configured to engage with a mating surface 186 on the RNS 58. Surface 184 of lug 164 of latch puller 160 is disengaged from corresponding surface 186 on RNS 58 when outer portion 20 is attached to lower housing frame 28. Surface 184 of lug 164 of puller is flat, although other suitable shapes and configurations may be used. The corresponding surface 186 on the RNS 58 is flat, although other suitable shapes and configurations may be used. The corresponding surface 186 on the RNS 58 is formed by the flange section on the RNS 58.

[00119] As seen in FIG. 17F, the syringe holder 24 is disengaged from the plunger portion 80 of the drive assembly 40 when the outer portion 20 is attached to the lower body frame 28. As shown in FIG. 19F, for example, the syringe holder 24 is engaged with the plunger portion 80 of the drive assembly 40 by axial movement of the outer portion 20 of the cap 18 away from the lower body frame 28. In particular, a pair of consoles extends from the syringe holder 24 and engages with the sound indicator element. 94 of the plunger portion 80, although other suitable configurations may be used. The engagement between syringe holder 24 and plunger portion 80 of drive assembly 40 prevents removal of outer portion 20 and RNS 58 from moving syringe holder 24 relative to cartridge portion 26 due to friction between syringe assembly 16 and syringe holder 24. The engagement between syringe holder 24 and plunger portion 80 also limits axial movement of syringe holder 24 within device 10 caused by movement of device 10 or by gravity when the device is in pre-use position.

[00120] As shown in FIG. 17A-17F, when the device 10 is in the storage position, with the outer portion 20 secured to the lower housing frame 28, the flange 176 of the latch 160 abuts against the outer portion 20 (FIG. 17B), the locking protrusion 166 of the outer portion 20 is located inside the hole 168 of the latch and spaced from the proximal portion of the main body 162 of the retainer 160 (FIG. 17C), the cap protrusion 120 fits into the cap hole 122 of the needle guard 22 and is spaced from the needle guard 22 (FIG. 17D), the surface 184 of the protrusion 164 of the puller is spaced from the corresponding surface 186 on RNS 58 (FIG. 17E), and syringe holder 24 is spaced from plunger portion 80 of drive assembly 40 (FIG. 17F). In the storage position of the device 10, the latch 160 is engaged with the syringe holder 24. When the flange 176 of the latch 160 abuts against the outer portion 20, the flat surface 184 of the lug 164 of the latch remover 160 is properly positioned relative to the mating surface 186 on the RNS 58. In other words, the abutment of the flange 176 against the outer portion 20 ensures that the latch 160 is seated at a sufficient axial distance. relative to the lower body frame 28 to allow the RNS 58 to be removed as described below.

[00121] As shown in FIG. 18A-18F, when outer portion 20 is initially moved axially away from lower body frame 28 (FIG. 18B), with locking lug 112 only partially seated in locking recess 114, flange 176 of latch 160 separates from outer portion 20, and locking lug 166 is all still separated from the main body 162 of the latch 160 (FIG. 18C), the protrusion 120 of the outer section 20 engages with the needle guard 22 (FIG. 18D), the surface 184 of the protrusion 164 of the stripper is separated from the corresponding surface 186 on the RNS 58 (Fig. 18E ), and the syringe holder 24 is spaced from the plunger portion 80 of the drive assembly 40 (FIG. 18F).

[00122] As shown in FIG. 19A-19F, when the outer portion 20 continues to be moved axially away from the lower body frame 28 (FIG. 19B), with the locking lug 112 only partially seated in the locking recess 114, the flange 176 of the latch 160 is spaced from the outer portion 20, and the locking lug 166 is all still separated from the main body 162 of the latch 160 (FIG. 19C), the protrusion 120 of the outer portion 20 is engaged with the needle guard 22 (FIG. 19D), the surface 184 of the protrusion 164 of the puller is spaced from the corresponding surface 186 on the RNS 58 (Fig. 19E ), and the syringe holder 24 is engaged with the plunger portion 80 of the drive assembly 40 (FIG. 19F).

[00123] As shown in FIG. 20A-20F, as the outer portion 20 continues to move axially away from the lower body frame 28 (FIG. 20B), with the locking lug 112 separated from the locking recess 114, the flange 176 of the latch 160 further separates from the outer portion 20 and the latch lug 166 engages engagement with the main body 162 of the latch 160 (FIG. 20C) so that the outer section 20 and the latch 160 move together axially from the lower body frame 28, the protrusion 120 of the outer section 20 is disengaged from the needle guard 22 (Fig. 20D) and removed from cap hole 122, the surface 184 of the puller protrusion 164 is spaced from the corresponding surface 186 on the RNS 58 (FIG. 20E), and the syringe holder 24 is engaged with the plunger portion 80 of the drive assembly 40 (FIG. 20F).

[00124] As shown in FIG. 21A-21F, when the outer portion 20 continues to be axially moved away from the lower body frame 28 (FIG. 21B), the flange 176 of the latch 160 is spaced from the outer portion 20, and the latch lug 166 is engaged with the body 162 of the latch 160 (FIG. 21C) so that the outer section 20 and the latch 160 move together axially from the lower body frame 28, the protrusion 120 of the outer section 20 continues to remain disengaged from the needle guard 22 (Fig. 21D), the surface 184 of the protrusion 164 of the stripper engages with the corresponding surface 186 on the RNS 58 (FIG. 21E), and the syringe holder 24 is engaged with the plunger portion 80 of the drive assembly 40 (FIG. 21F).

[00125] As shown in FIG. 22A-22F, when the outer portion 20 continues to be axially moved away from and separated from the lower body frame 28 (FIG. 22B), the flange 176 of the latch 160 is spaced from the outer portion 20 and the latch lug 166 is engaged with the body 162 of the latch 160 (FIG. 22C) such that outer portion 20 and latch 160 co-move axially away from lower body frame 28, outer portion 20 projection 120 continues to be disengaged from needle guard 22 (FIG. 22D), puller projection 164 surface 184 continues to engage with the corresponding surface 186 on the RNS 58 and axially moves the RNS 58 relative to the barrel 52 of the syringe assembly 16 (FIG. 22E), and the syringe holder 24 is engaged with the plunger portion 80 of the drive assembly 40 (FIG. 22F).

[00126] As shown in FIG. 23, after the outer portion 20 is completely removed from the lower body frame 28, the RNS 58 continues to be engaged with the retainer 160, with the RNS 58 completely separated from the barrel 552 of the syringe 16 assembly.

[00127] As also shown in FIG. 17A-24 and described above, the outer portion 20 and latch 160 are configured to minimize the amount of force required to remove the outer portion 20 and latch 160 from device 10 by separating the various components from each other sequentially rather than simultaneously. By sequentially removing outer portion 20 from lower body frame 28, separating outer portion 20 protrusion 120 from needle guard 22, and removing RNS 58 from syringe assembly 16, the patient is only required to apply sufficient force for each step in the sequence, rather than more significant force that would be required to remove such components at the same time. As described above, such sequential execution is achieved by relative movement between outer portion 20 and latch 160, relative movement between outer portion 20 and needle guard 22, and relative movement between latch 160 and RNS 58.

[00128] FIG. 25-49 show a drug delivery device 300 in accordance with a further aspect of the present invention. The drug delivery device 300 is similar to the drug delivery device 10 shown in FIG. 1A-24, with some differences detailed below. The drug delivery device 300 includes, among other components, a drive guide 302, a plunger portion 304, a plunger stem portion 306, a lever trigger 308, a syringe holder 310, a needle guard 312, a cartridge portion 314, a cap 316, a retainer 318, an upper body frame 320 and lower body frame 322.

[00129] As shown in FIG. 24-28, the drive rail 302 is similar and functions in a similar manner to the drive rail 42 shown in FIG. 1A-24, but further includes a longitudinal groove 324, stiffener(s) 326, and cartridge clamp(s) 328. The longitudinal groove 324 is configured to receive a mold parting line on the plunger portion 304 to provide a smooth sliding the plunger portion 304 along the drive guide 302. Rib(a) 326 stiffness provide additional support for a pair of consoles 260 guide 302 of the drive. The cassette clip(s) 328 fit into the hole(s) 330 formed in the cassette portion 314 to secure the drive guide 302 to the cassette portion 314, as detailed below. The cassette clip(s) 328 includes(s) an inclined surface 332 and a flat surface 334 that are configured to allow the cassette clip(s) 328 to be inserted into the opening(s) 330 of the cassette portion 314, but prevent easy removal of the cassette clip(s) 328 after being inserted into the opening(s) 330 of the cassette portion 314. The bottom surface 336 of the drive rail 302 includes chamfered portions 338 to facilitate assembly of the device 300.

[00130] As shown in FIG. 26 and 29-32, the plunger portion 304 is formed separately from the plunger stem portion 306, instead of being integrally formed. In addition, the device 300 does not include the shell 92 of the plunger rod. The plunger portion 304 defines an opening 340 that receives the plunger stem retainer 342 of the plunger stem portion 306 . Plunger rod retainer 342 is swept-back and designed to be inserted into bore 340 of plunger portion 304 but blocks easy removal from bore 340, although other suitable shapes and configurations may be used. The plunger rod retainer 342 defines a central hole 344 that allows the plunger rod retainer 342 to contract when the plunger rod retainer 342 is inserted into the bore 340 of the plunger portion 304 and to expand to its original shape after being inserted into the plunger portion 304. The plunger rod portion 306 includes a stopper Plunger portion(s) 346 and thrust member 348. Plunger portion stop(s) 346, which may be one or more protrusions, contact plunger portion 304 when plunger stem retainer 342 is inserted into bore 340 of plunger portion 304. Clamp member 348 is engaged with plunger portion 304 during insertion of plunger stem retainer 342 into bore 340 of plunger portion 304 and presses plunger stem portion 306 against plunger portion 304. Compression member 348 provides additional allowance for insertion of plunger stem retainer 342 into bore 340 of plunger portion 304, while ensuring the absence of clearance between plunger portion 304 and plunger stem portion 306 after assembly. The clamping element 348 of the plunger rod section 306 is annular, although other suitable shapes and configurations can be used.

[00131] Plunger stem portion 306 further includes a plug interface 350 that fits into plug 54. Plug interface 350 is a cross-shaped protrusion, although other suitable shapes and configurations may be used. Plunger stem portion 306 has a tapered outer shape designed to reduce stress on the syringe 16 assembly, although other suitable shapes may be used. The plunger portion 304 includes a lever rib 352 extending into the lever opening 88 of the plunger portion 304. The lever rib 352 is configured to receive a lever trigger 308, as described in detail below.

[00132] As shown in FIG. 33 and 34, the lever trigger 308 is similar and functions in a similar manner to the lever trigger 44 described above and shown in FIG. 1A-24. However, the lever trigger 308 is formed recess 354 on the axis of rotation 70, which accommodates the rib 352 of the lever of the plunger portion 304. the needle guard on the trigger 308 includes a surface enlarged from the needle guard contact surface 142 on the trigger 44 shown in FIG. 1A-24.

[00133] As shown in FIG. 35 and 36, the syringe holder 310 is similar and functions in a similar manner to the syringe holder 24 shown in FIG. 1A-24. However, the syringe holder 310 further includes a plurality of ribs 356 extending around the circumference of the syringe holder 310. A plurality of ribs are engaged with the spring 68. The attachment ring 220 of the syringe holder 310 further includes a plurality of protrusions 358 that extend radially inward. A plurality of protrusions 358 are engaged with the syringe assembly 16 to select any gap between the outer surface of the syringe assembly 16 and the syringe holder 310. The plurality of protrusions 358 are resilient and can be compressed when the syringe assembly 16 fits into the syringe holder 310.

[00134] As shown in FIG. 37 and 38, the needle guard 312 is similar and functions in a similar manner to the needle guard 22 shown in FIG. 1A-24. The needle guard 312 includes a spring rib 360 that is engaged with the spring 68 to retain the spring 68 between the needle guard 312 and the syringe holder 310. Needle guard 312 also includes cartridge rib(s) 362 to guide movement of needle guard 312 relative to cartridge portion 314.

[00135] As shown in FIG. 39, 40, 48, and 49, the cartridge portion 314 is similar and functions in a similar manner to the cartridge portion 26 shown in FIG. 1A-24. As described above, the cassette portion 314 includes an opening(s) 330 that(s) accommodate(s) cassette(s) clip(s) 328 of the guide 302 of the drive. The cassette portion 314 includes needle guard latch(s) 364 that are engaged with the needle guard 312 gripping surface(s) 366 . The grip surface(s) 366 of the needle guard 312 are flat, although other suitable shapes and configurations may be used. The needle guard latch(s) 364 are configured to limit axial movement of the needle guard 312 relative to the cartridge portion 314. The cartridge portion 314 further includes rib(s) 368 under the drive guide and rib(s) 370 under the upper case frame, which are configured to engage with respective portions of the drive rail 302 and the upper housing frame 320 to facilitate assembly of the device 300. syringe holder 310 to limit axial movement of syringe holder 310 relative to cartridge portion 314. Although FIG. 48 and not shown, a retaining clip 64 can also be used with the drug delivery device 300.

[00136] As shown in FIG. 41-46, cap 316 is similar and functions in a similar manner to cap 18 described above and shown in FIG. 1A-24. Cap 316 includes projection(s) 374 that(s) fit into cap hole(s) 376 formed in needle guard 312 that is(are) located at 90 degrees relative to data position. elements of the cap 18 shown in FIG. 1A-24. The protrusion(s) 374 of the cap 316 are(are) configured to engage with the needle guard 312 when the needle guard 312 is moved from the pre-use position to the firing position. For example, in the case of the device 300 in the storage position, with the cap 316 attached to the lower body frame 322, if the device is dropped or subjected to a forceful impact against the needle guard 312, the lever trigger 308 and/or other component, the protrusion( s) 374 restrict(s) the movement of the needle guard 312, which prevents any unintentional actuation of the device 300. The cap 316 further includes a catch(s) 378 of the latch and a rib(s) 380 for engagement with the tab(s) 382 of the latch 318. The retainer grip(s) 378 and rib(s) 380 secure the retainer 318 to the cap 316 and prevent any movement or rocking of the retainer 318 relative to the cap 316. The retainer 318 is configured to release the RNS 58 when the cap 316 is removed from the lower housing frame 322. The cap 316 includes lower body frame grip(s) 384 for engagement with lower body frame 322 to secure cap 316 to a bottom body frame. lower body frame 322. Upper body frame 320 and lower body frame 322 are similar and function in a similar manner to upper body frame 46 and lower body frame 28 described above and shown in FIG. 1A-24. However, the lower body frame 322 has a cap interface 386 for receiving the lower body frame grip(s) 384 provided on the cap 316.

[00137] FIG. 47, the drug delivery device 300 is shown in an injection position. The injection depth of the cannula 56 is determined by the contact between the syringe holder 310 and the cartridge portion 314 at point X and the contact between the needle guard 312 and the syringe holder 310 at point Y.

[00138] As shown in FIG. 47, the drug delivery device 300 includes an audible indicator element 388 that is similar to, and functions in a similar manner to, the audible indicator element 94 described above and shown in FIG. 1A-24. In the same manner as the audible indicator element 94 described above, the audible indicator element 388 of the drug delivery device 300 is configured to provide an audible indication to the user when the device 300 enters a post-use position. The sound indicator element 388 is configured to engage with the rib(s) 390 of the cartridge portion 314 when the device 300 is in the injection position, which deflects the sound indicator element 388. The sound indicator element 388 disengages from the rib(s) 390 of the cartridge portion 314 and contacts with lower body frame 322 to provide an audible click when the drug delivery device 300 transitions from an injection position to a post-use position. However, the distal end 392 of the rib(s) 390 of the cartridge 314 slopes backwards in the direction of the upper body frame 320, which preferably provides a louder audible click compared to the location of the rib(ep) 96 of the cartridge 26 described above in connection with FIG. 1A-24.

[00139] In one aspect or embodiment, the angle Z of the distal end 392 of the fin(s) 390 of the cartridge portion 314 with respect to a plane extending perpendicular to the longitudinal axis of the device 300 is greater than 5 degrees. In one aspect or embodiment, the Z angle of the distal end 392 of the rib(ep) 390 is greater than 10 degrees. In one aspect or embodiment, the Z angle of the distal end 392 is 25 degrees.

[00140] Elements of one disclosed aspect can be combined with elements of one or more other disclosed aspects to form different combinations, which are considered to be included in the scope of the present invention.

[00141] While the present invention has been described above using exemplary constructions, the present invention may be further modified within the spirit and scope of the present invention. Therefore, the present application is intended to cover any modification, application, or development of the invention using its general principles. Furthermore, the present application is intended to cover such variations of the present invention as occur within the known or ordinary practice in the art to which the invention pertains, and which do not depart from the scope of the appended claims.

Claims (38)

1. Device (10) for the delivery of liquid drugs, containing: body (26, 28, 46); a syringe (16) assembly containing a cylinder (52), a plug (54), a cannula (56) and a hard needle sheath (58) containing at least a section of the cannula (56), while at least a section the syringe (16) assembly is located inside the housing (26, 28, 46); drive unit (40) configured to move the plug (54) inside the cylinder (52) when the drive unit (40) is actuated, and at least a section of the drive unit (40) is located inside the housing (26, 28, 46) ; a cap (18) attached to the body (26, 28, 46), wherein the cap (18) contains an outer section (20) delimiting the inner space (118), and a latch (160) containing a main part (162) with a protrusion ( 164) of the stripper, and the protrusion (164) of the stripper, made with the possibility of removing the hard needle cover (58), with axial movement of the outer section (20) of the cap (18) from the body (26, 28, 46); and a pair of tabs (170) extending radially outward from the main part (162) of the latch (160), with each tab (170) being able to engage with a rib (172) extending radially inward from the main part (116) of the outer section ( twenty); and a needle guard (22) having a position before use, in which the cannula (56) is located inside the needle guard (22), an actuation position in which the drive unit (40) is activated, and a position after use, in which the cannula (56) is located inside the protective fence (22) of the needle, and the outer section (20) contains a section of the protective fence (22) of the needle, the outer section (20) is configured to prevent the movement of the protective fence (22) of the needle from the position before use to the position of operation. 2. The drug delivery device (10) according to claim 1, wherein the outer portion (20) comprises a protrusion (120) fitting into the cap hole (122) formed in the needle guard (22), wherein the protrusion (120) the outer section (20) is configured to engage with the needle guard (22) when the needle guard (22) is moved from the pre-use position to the firing position. 3. The drug delivery device (10) according to claim 1 or 2, in which the latch portion (160) fits in the inner space (118) of the outer portion (20) of the cap (18), and the latch (160) is fixed to the outer section (20) and allows axial movement relative to it. 4. The drug delivery device (10) according to claim 3, in which the outer portion (20) contains a locking protrusion (166) that fits into the hole of the lock (168) formed in the main part (162) of the lock (160), while locking the protrusion (166) is disconnected from the main part (162) of the latch (160), when the outer section (20) is fixed to the body (26, 28, 46), the locking protrusion (166) of the outer section (20) is made with the possibility of engagement with the latch ( 160), with axial movement of the outer section (20) from the housing (26, 28, 46) and with axial movement of the outer section (20) relative to the latch (160). 5. The drug delivery device (10) of claim 4, wherein the locking lug (166) extends radially outward through the lock (168) opening in the lock (160). 6. The drug delivery device (10) according to claim 4, in which the fixing protrusion (166) of the outer section (20) is fixed to the main part (116) of the outer section (20) by means of an elongated console (174), while the fixing protrusion (166 ) is able to move radially inward thanks to the extended arm (174). 7. Device (10) drug delivery according to any one of paragraphs. 1-4 or 5, 6, in which the latch (160) contains a flange (176) engaged with the outer section (20) when the outer section (20) is fixed to the body (26, 28, 46). 8. The drug delivery device (10) according to claim 7, in which the flange (176) of the latch (160) is separated from the outer section (20) by axial movement of the outer section (20) from the housing (26, 28, 46). 9. Device (10) drug delivery according to any one of paragraphs. 1-4 or 5-8, in which the surface (184) of the protrusion (164) of the stripper is flat, and the corresponding surface (186) of the rigid needle cover (58) is flat. 10. Device (10) drug delivery according to any one of paragraphs. 1-4 or 5-9, in which the main part (162) of the latch (160) contains the first end (178) and the second end (180) located opposite the first end, while the protrusion (164) of the puller extends radially inward from the main part (162) of the latch (160) by means of the console (182) of the stripper, and the console (182) of the stripper extends radially inward and in a direction extending from the second end (180) of the main part (162) to the first end (178) of the main part (162) . 11. The drug delivery device (10) according to claim 10, in which the protrusion (164) of the puller is able to move relative to the body (162) of the latch (160) due to the arm (182) of the puller. 12. Device (10) drug delivery according to any one of paragraphs. 1-4 or 5-11, additionally containing a syringe holder (24) located inside the housing (26, 28, 46), while the syringe holder (24) accommodates the syringe (16) assembly, the syringe holder (24) is movable relative to housing (26, 28, 46), wherein the syringe holder (24) is disengaged from the drive unit (40), when the outer portion (20) is fixed to the housing (26, 28, 46), and the syringe holder (24) is engaged with the drive unit (40), with axial movement of the outer section (20) from the body (26, 28, 46). 13. Device (10) drug delivery according to any one of paragraphs. 1-4 or 5-12, in which the surface (184) of the protrusion (164) of the stripper is configured to engage with the corresponding surface (186) of the hard needle cover (58) to remove the hard needle cover (58), with axial movement of the outer section (20) the cap (18) from the body (26, 28, 46), wherein the surface (184) of the protrusion (164) of the puller is separated from the corresponding surface (186) of the hard needle cover (58) when the outer section (20) is fixed to the body (26, 28, 46). 14. The drug delivery device (10) according to claim 13, in which the protrusion (120) is adapted to be removed from the opening (122) for the cap before the surface (184) of the protrusion (164) of the stripper engages with the corresponding surface ( 186) of a rigid needle cover (58), with axial movement of the outer section (20) from the body (26, 28, 46). 15. Device (10) drug delivery according to any one of paragraphs. 1-4 or 5-14, in which the outer section (20) contains one of the locking lug (112) and the locking recess (114), and the body (26, 28, 46) contains the other element of the locking lug (112 ) and locking recess (114), wherein the locking lug (112) fits into the locking recess (114) to secure the outer section (20) to the housing (26, 28, 46), and wherein the locking lug (112) is separated from the locking notches (114) before the surface (184) of the protrusion (164) of the stripper engages with the corresponding surface (186) of the hard needle cover (58), with axial movement of the outer section (20) from the body (26, 28, 46) . 16. Device (10) for the delivery of liquid drugs, containing: body (26, 28, 46); a syringe (16) assembly containing a cylinder (52), a plug (54), a cannula (56) and a hard needle sheath (58) containing at least a section of the cannula (56), while at least a section the syringe (16) assembly is located inside the housing (26, 28, 46); drive unit (40) configured to move the plug (54) inside the cylinder (52) when the drive unit (40) is actuated, and at least a section of the drive unit (40) is located inside the housing (26, 28, 46) ; a cap (18) attached to the body (26, 28, 46), wherein the cap (18) contains an outer section (20) delimiting the inner space (118), and a latch (160) containing a main part (162) with a protrusion ( 164) of the stripper, and the protrusion (164) of the stripper is made with the possibility of removing the hard needle cover (58), with axial movement of the outer section (20) of the cap (18) from the body (26, 28, 46); and a needle guard (22) having a position before use, in which the cannula (56) is located inside the needle guard (22), an actuation position in which the drive unit (40) is activated, and a position after use, in which the cannula (56) is located inside the protective fence (22) of the needle, and the outer section (20) contains the section of the protective fence (22) of the needle, the outer section (20) is configured to prevent the movement of the protective fence (22) of the needle from the position before use to the position of operation, and the main part (162) of the latch (160) contains the first end (178) and the second end (180) located opposite the first end, while the protrusion (164) of the puller extends radially inward from the main part (162) of the latch (160) through the console (182 ) of the puller, and the console (182) of the puller extends radially inward and in a direction extending from the second end (180) of the main part (162) to the first end (178) of the main th part (162). 17. The drug delivery device (10) according to claim 16, in which the outer portion (20) contains a protrusion (120) that fits into the cap hole (122) formed in the needle guard (22), while the protrusion (120) the outer section (20) is configured to engage with the needle guard (22) when the needle guard (22) is moved from the pre-use position to the firing position. 18. The drug delivery device (10) according to claim 16 or 17, in which the latch portion (160) fits in the inner space (118) of the outer portion (20) of the cap (18), and the latch (160) is fixed to the outer section (20) and allows axial movement relative to it. 19. The drug delivery device (10) according to claim 18, in which the outer section (20) contains a locking protrusion (166) that fits into the hole of the lock (168) formed in the main part (162) of the lock (160), while locking the protrusion (166) is disconnected from the main part (162) of the latch (160), when the outer section (20) is fixed to the body (26, 28, 46), the locking protrusion (166) of the outer section (20) is made with the possibility of engagement with the latch ( 160), with axial movement of the outer section (20) from the housing (26, 28, 46) and with axial movement of the outer section (20) relative to the latch (160). 20. The drug delivery device (10) of claim 19, wherein the locking lug (166) extends radially outward through the lock (168) opening in the lock (160). 21. The drug delivery device (10) according to claim 19, in which the fixing protrusion (166) of the outer section (20) is fixed to the main part (116) of the outer section (20) by means of an elongated console (174), while the fixing protrusion (166 ) is able to move radially inward thanks to the extended arm (174). 22. Device (10) drug delivery according to any one of paragraphs. 16-21, in which the latch (160) includes a flange (176) engaged with the outer section (20) when the outer section (20) is fixed to the housing (26, 28, 46). 23. The drug delivery device (10) according to claim 22, in which the flange (176) of the latch (160) is separated from the outer section (20) by axial movement of the outer section (20) from the housing (26, 28, 46). 24. Device (10) drug delivery according to any one of paragraphs. 16-23, in which the surface (184) of the protrusion (164) of the stripper is flat, and the corresponding surface (186) of the rigid needle cover (58) is flat. 25. Device (10) drug delivery according to any one of paragraphs. 16-24, additionally containing a syringe holder (24) located inside the housing (26, 28, 46), while the syringe holder (24) accommodates the syringe (16) assembly, the syringe holder (24) is movable relative to the housing (26, 28, 46), wherein the syringe holder (24) is disengaged from the drive assembly (40) when the outer portion (20) is secured to the body (26, 28, 46), and the syringe holder (24) is engaged with the drive assembly (40). ) drive, with axial movement of the outer section (20) from the body (26, 28, 46). 26. Device (10) drug delivery according to any one of paragraphs. 16-25, in which the surface (184) of the protrusion (164) of the stripper is configured to engage with the corresponding surface (186) of the hard needle cover (58) to remove the hard needle cover (58), with axial movement of the outer portion (20) of the cap (18) from the body (26, 28, 46), wherein the surface (184) of the protrusion (164) of the puller is separated from the corresponding surface (186) of the hard needle cover (58), when the outer section (20) is fixed to the body (26, 28 , 46). 27. The drug delivery device (10) of claim 26, wherein the protrusion (120) is retractable from the cap hole (122) before the surface (184) of the protrusion (164) of the puller engages with the corresponding surface ( 186) of a rigid needle cover (58), with axial movement of the outer section (20) from the body (26, 28, 46). 28. The device (10) drug delivery according to paragraphs. 16-27, in which the protrusion (164) of the puller is movable relative to the main part (162) of the latch (160) by means of the console (182) of the puller.

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