Cassette for an autoinjector and related methods

Abstract

A cassette for a drug delivery device is described, the cassette including a sleeve, a syringe having a barrel disposed within the sleeve, and a plunger stopper slidably disposed within the barrel. The cassette further includes a spacer configured to be coupled to the sleeve. The cassette, together with the drug delivery device, may form part of an apparatus for injecting a therapeutic product.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 912,540, filed October 8, 2019, which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates generally to drug delivery devices, and more particularly to autoinjector devices. [Background technology]

[0003] Prefilled hypodermic syringes offer several advantages to the home market. These advantages include the ability to prepare prefilled syringes with the exact required dosage for each medication. Furthermore, prefilled syringes are easily operated by simply advancing the plunger stopper of the syringe. Aside from the cost of the specific medication used, prefilled syringes are also economical to manufacture. As a result, all of these advantages make prefilled syringes commercially attractive.

[0004] Nevertheless, pre-filled syringes also have significant drawbacks in the market. Specifically, many users are afraid of exposed injection needles or are essentially unable to perform injections. Due to the aversion to exposed needles and the associated health and safety issues, various types of injectors and other devices have been developed with the specific purpose of hiding needles from users and automating injection procedures to assist users in performing injections. One such injector is a reusable auto-injector that accepts a cartridge with a pre-filled syringe inside. The user positions the auto-injector in the desired injection position in the correct orientation and activates a user input, and one or more drives of the auto-injector move the syringe to insert the needle into the subcutaneous position, and the plunger rod engages with the plunger stopper and drives the plunger stopper through the syringe barrel, thereby expelling a dose of drug from the syringe.

[0005] Different syringes with a range of barrel diameters can be used with the same autoinjector. The plunger stoppers for such syringes have a similar range of diameters. However, the size and geometry of the plunger rods used to engage the various plunger stoppers tend to remain constant. A plunger rod suitable for a small-diameter barrel and plunger stopper may provide poor operation when used in a large-diameter barrel with a large-diameter plunger stopper, and vice versa. Summary of the Invention [Means for solving the problem]

[0006] According to a first aspect, a cassette for a drug delivery device is described, the cassette including: a sleeve having a proximal end and a distal end with an opening; a syringe disposed within the sleeve, the syringe including a barrel having a distal opening coaxially aligned with the opening at the distal end of the sleeve; and a plunger stopper slidably disposed within the barrel. The cassette further includes a spacer having a proximal end and a distal end, the distal end configured to be inserted into the opening to couple the spacer to the sleeve. The distal end of the spacer is adapted to be engaged by a plunger rod of a drive mechanism to separate the spacer from the sleeve, slide the spacer within the barrel, and engage the plunger stopper with the proximal end of the spacer.

[0007] According to some embodiments, the sleeve can include an annular wall extending around the opening, and the distal end of the spacer can be configured to engage an inner surface of the annular wall.

[0008] According to some embodiments, the sleeve may include a locking cap configured to secure the syringe within the sleeve. In further embodiments, the opening of the sleeve may be defined by a portion of the locking cap extending over the distal opening of the barrel, such that the spacer is configured to couple to the locking cap. In some embodiments, the portion of the locking cap may be a generally planar body, and the annular wall may be integral with the body. In these embodiments, the locking cap may further include a gasket configured to couple to the body with a major surface of the gasket extending along an inner surface of the body, the major surface defining an opening configured to be coaxially aligned with the opening of the body, and the distal end of the spacer configured to be inserted through the opening in the gasket. In a further aspect, the spacer may include a neck portion disposed between the proximal and distal ends and having a reduced diameter relative to the proximal and distal ends to define a space between the proximal and distal ends, the opening in the gasket may have a diameter sized such that a portion of the major surface extends into the space between the proximal and distal ends of the spacer, and / or the gasket may include one or more rims extending away from the major surface, the rims including lips configured to engage the body and couple the gasket to the body. In any of the above aspects, the sleeve may include a cover configured to couple to the distal end of the sleeve, the locking cap disposed proximal to the cover, the cover including an opening therethrough and an annular wall extending around the opening and extending proximally, the annular wall of the cover extending around the annular wall of the locking cap. In some forms, the locking cap may include a tubular member including an annular wall and a generally planar body having an annular configuration, the tubular member being coupled to the body by the annular wall extending into the body.In some forms, the tubular member may include a flange extending along the body, the body and tubular member being overmolded onto one another, with connecting posts of the tubular member extending from the flange through openings in the body, and / or the spacer may include a neck portion disposed between the proximal and distal ends and having a reduced diameter relative to the proximal and distal ends to define a space therebetween, and the tubular member may include one or more protrusions extending radially inward from the annular wall, the protrusions sized to extend at least partially into the space between the proximal and distal ends of the spacer.

[0009] A cassette according to any of the above aspects may include one or more of the following aspects: the proximal end of the spacer may have a diameter approximately equal to the diameter of the plunger stopper; the proximal end of the spacer may include one or more grooves extending along an outer surface of the proximal end of the spacer; the distal end of the spacer may include a plurality of ribs extending radially outward from the distal end of the spacer, the plurality of ribs providing an outer diameter of the distal end for frictionally engaging the locking cap; the spacer may have a cup-like configuration having a distal end wall and a cavity having an opening through the proximal end; the distal end face of the spacer may be configured to be flush with the distal end face of the locking cap when the spacer is frictionally coupled to the locking cap; the cassette may include an outer housing, the outer housing configured to movably receive a sleeve and a syringe; or the cassette may contain a therapeutic product within the syringe.

[0010] According to a second aspect, an apparatus for injecting a therapeutic product is described, comprising a drug delivery device including a drive and a plunger rod, and a cassette for use with the drug delivery device. The cassette may have any of the forms described above.

[0011] According to a third aspect, a method of preparing a cassette for an autoinjector is described, comprising: placing a plunger stopper in a barrel of a syringe; placing the syringe in a sleeve; inserting a distal end of a spacer into an opening in the sleeve and coupling the spacer to the sleeve, the opening aligning with the distal opening of the barrel of the syringe to coaxially align the spacer with the barrel of the syringe.

[0012] According to some embodiments, inserting the distal end of the spacer into the opening of the sleeve can include inserting the distal end of the spacer into the opening of the locking cap and coupling the spacer to the locking cap, and the method can further include coupling the locking cap to the distal end of the sleeve such that the spacer is coaxially aligned with the distal opening of the syringe barrel. In some embodiments, inserting the distal end of the spacer into the opening of the locking cap can include inserting the distal end into a cavity defined by an annular wall of the locking cap, the distal end configured to frictionally engage an inner surface of the annular wall.

[0013] According to further aspects, the method may include one or more of the following aspects: inserting the distal end of the spacer into the cavity defined by the annular wall may further include inserting the distal end of the spacer through an opening in a gasket or member coupled to the body of the locking cap such that a portion of the gasket or member extends into a space between the distal end of the spacer and the proximal end of the spacer; the method may include selecting a spacer based on the size of the plunger stopper and the size of the proximal end of the spacer; the method may include selecting a sleeve based on the size of an internal bore defined by one or more inner walls of the sleeve and the diameter of the barrel of the syringe; or the method may include filling the syringe with a therapeutic product.

[0014] According to a fourth aspect, a method of assembling a cassette for a drug delivery device is described, comprising: selecting a syringe having a barrel with an outer diameter; selecting a sleeve from a first sleeve and a second sleeve, the first sleeve and the second sleeve having a common external configuration, a common outer dimension, and an internal bore defined by one or more walls having different diameters, wherein selecting the sleeve comprises selecting one of the first sleeve and the second sleeve having an internal bore sized to support the barrel of the syringe; inserting the syringe into the sleeve; and inserting the syringe and the sleeve into a housing, the housing configured to be coupled to the common external configuration of the first sleeve and the second sleeve.

[0015] According to some embodiments, the internal bores of the first and second sleeves may be defined by a number of radial ribs extending within the interior of the sleeves. [Brief explanation of the drawings]

[0016] [Figure 1] FIG. 1 is a side view of an exemplary embodiment of an autoinjector device including an autoinjector and a cassette. [Figure 2] 2 is an exploded perspective view of the exemplary embodiment of the cassette of FIG. 1 showing the outer housing, inner sleeve, syringe, shield remover, locking cap, and cover. FIG. [Figure 3] FIG. 2 is a top-down front perspective view of the cassette of FIG. 1. [Figure 4] FIG. 2 is a cross-sectional side view of the cassette of FIG. 1; [Figure 5] FIG. 10 is a front perspective view of an exemplary locking cap for a sleeve. [Figure 6] FIG. 6 is a rear perspective view of a portion of the sleeve and syringe with the locking cap of FIG. 5. [Figure 7] 7 is a side view of a portion of the sleeve and syringe with the locking cap of FIG. 6. FIG. [Figure 8]FIG. 10 is a front perspective view of a portion of a sleeve having a second exemplary locking cap. [Figure 9] FIG. 1 is a perspective view of a first exemplary spacer. [Figure 10] FIG. 10 is a perspective view of a second exemplary spacer. [Figure 11] FIG. 10 is a bottom perspective view of a first exemplary locking cap for a sleeve of a cassette having an annular wall for receiving a portion of a spacer. [Figure 12] FIG. 12 is a top perspective view of the locking cap of FIG. 11. [Figure 13] 12 is an exploded cross-sectional view of the first exemplary cassette showing the cover, the sleeve with the locking cap of FIG. 11, the spacer of FIG. 9 coupled to the sleeve, and a syringe. [Figure 14] FIG. 14 is a perspective cross-sectional view of the cassette of FIG. 13. [Figure 15] 12 is an exploded cross-sectional view of the second exemplary cassette showing the cover, the sleeve with the locking cap of FIG. 11, the spacer of FIG. 10 coupled to the sleeve, and a syringe. [Figure 16] FIG. 14 is a perspective cross-sectional view of the cassette of FIG. 13. [Figure 17] FIG. 10 is a perspective view of a gasket for a locking cap. [Figure 18] 18 is a perspective view of a second exemplary locking cap for a sleeve and the spacer of FIG. 10, wherein the locking cap includes the gasket of FIG. 17. [Figure 19] FIG. 19 is a cross-sectional view of the locking cap and spacer of FIG. 18. [Figure 20] FIG. 10 is a perspective view of a third exemplary locking cap for a sleeve including a tubular member coupled to a body. [Figure 21] FIG. 21 is a cross-sectional view of the locking cap of FIG. 20. [Figure 22] 21 is a cross-sectional view of the locking cap of FIG. 20 including the spacer of FIG. 9. [Figure 23] FIG. 1 is a perspective view of a first exemplary sleeve for a cassette. [Figure 24] FIG. 10 is a perspective view of a second exemplary sleeve for a cassette. [Figure 25] 2 is a front perspective view looking up from below of the cassette of FIG. 1 showing the bottom surface having the protrusions. FIG. [Figure 26] FIG. 26 is a bottom view of the cassette of FIG. 25 showing the protrusions and latching mechanism. [Figure 27] FIG. 2 is a front view of the autoinjector of FIG. 1. [Figure 28] FIG. 2 is an elevational view of the autoinjector of FIG. 1. [Figure 29] FIG. 2 is a rear view of the autoinjector of FIG. 1. [Figure 30] FIG. 2 is an elevational view of a second side of the autoinjector of FIG. 1. [Figure 31] FIG. 2 is an elevational view of a first end of the autoinjector of FIG. 1. [Figure 32] FIG. 2 is an elevational view of a second end of the autoinjector of FIG. 1. [Figure 33] FIG. 2 is a cross-sectional side view of the autoinjector and cassette of FIG. 1. [Figure 34] FIG. 2 is a top-down side perspective view of an exemplary motorized insertion drive 330 for the autoinjector of FIG. 1. [Figure 35] FIG. 35 is a bottom, top-up perspective view of the motorized insertion drive of FIG. 34; [Figure 36] FIG. 2 is an exploded side perspective view of the plunger rod, lead screw, and nut of the motorized ejection drive for the autoinjector of FIG. 1. [Figure 37] FIG. 37 is a side perspective view of the assembled plunger rod, lead screw, and nut of FIG. 36. [Figure 38] FIG. 38 is a perspective view of a portion of the motorized ejection drive of FIGS. 34 to 37. DETAILED DESCRIPTION OF THE INVENTION

[0017] Described herein are a cassette for a drug delivery device, an apparatus for injecting a therapeutic product, and an associated method, which utilize a spacer to provide an intermediate member between the plunger stopper of the cassette's syringe and the plunger rod of the drug delivery device. The spacer may be coupled to the cassette's sleeve in a press-fit engagement, allowing the spacer to be reliably separated by the plunger rod during the ejection process. Furthermore, the proximal end of the spacer may be specifically tailored for a particular plunger stopper and barrel size to ensure proper engagement and seating between these components. The spacer may include a venting feature to prevent air from being trapped between the spacer and plunger stopper as they move relative to each other within the barrel. During the drug ejection operation, the spacer is spaced from the plunger stopper and engaged by the plunger rod to slide within the barrel and engage the plunger stopper.

[0018] FIG. 1 shows an elevation view of an exemplary embodiment of an autoinjector device 100 according to the present disclosure. The autoinjector device 100 includes an autoinjector 300 and a cassette 200. The autoinjector 300 may include a cassette door 308 that, in an open position (as shown), allows insertion of the cassette 200 into the cassette door 308 and, in a closed position (e.g., FIG. 28), aligns the cassette 200 with the insertion drive 330 and ejection drive 340 ( FIG. 33 ), respectively, of the autoinjector 300. The autoinjector 300 may be constructed and adapted for manual operation and may be reusable. The cassette 200 may be constructed and adapted to house and protect a syringe 260 (e.g., FIG. 2 ), which may be pre-filled with a predetermined dose of a pharmaceutical agent. Cassette 200 facilitates and enables easy use of the syringe with auto-injector 300 and helps prevent needle sticks before and after use. Additionally, cassette 200 may be constructed and adapted for single-use disposability.

[0019] FIG. 2 shows an exploded perspective view of an exemplary embodiment of a cassette 200 according to the present disclosure. The cassette 200 may include an outer housing 210, an inner sleeve 220 slidably movable within the outer housing 210, a syringe 260 disposed within or retained by the inner sleeve 220, and a shield remover 240 for removing a protective needle shield 266 of the syringe 260. The outer housing 210 may include a proximal end wall 214 and an open distal end 216. The proximal end wall 214 of the outer housing 210 may include an aperture 214A sized and shaped to receive the shield remover 240. The inner sleeve 220 may include a proximal end wall 222 and an open distal end 224. The proximal end wall 222 of the inner sleeve 220 may include an aperture 222A sized and shaped to receive the protective needle shield 266 of the syringe 260. Sleeve 220 may further include an end cap or locking cap 230 for closing open distal end 224 of inner sleeve 220 to secure or lock syringe 260 within inner sleeve 220. Cassette 200 may further include a cover 250 for closing open distal end 216 of outer housing 210. Cover 250 provides tamper resistance and completes the appearance of cassette 200 by covering inner sleeve 220 and syringe 260 containing medication 267 within outer housing 210 of cassette 200.

[0020] FIG. 3 shows a top-down front perspective view of cassette 200. The outer housing 210 of cassette 200 may include elongated openings or windows 212 in each side wall 211 thereof. The windows 212 may be positioned opposite each other and aligned with each other. Additionally, the inner sleeve 220 of cassette 200 may be made from a transparent, rigid material, such as clear polycarbonate. The windows 212 in the side walls 211 of the outer housing 210, in combination with the transparent inner sleeve 220, allow for visualization of the syringe 260 housed within the inner sleeve 220 ( FIG. 4 ). The wall portion of the inner sleeve 220 visible through the windows 212 in the outer housing 210 may include a fill level indicator (not shown). The outer housing 210 of cassette 200 may also include a pin 215 or any other suitable mechanical structure that prevents the cassette 200 from being inserted into the cassette door 308 in the wrong direction and / or orientation. An "arrow" icon may be provided on the shield remover 240 or outer housing 210 (not shown) to indicate the proper direction and orientation of cassette insertion into the cassette door 308.

[0021] 4 shows a side cross-sectional view of cassette 200. As can be seen, inner sleeve 220 may include an inner sleeve pin 268 that may be engaged by an insertion drive 330 ( FIG. 33 ) of autoinjector 300 during operation of autoinjector 300. When driven by insertion drive 330, pin 268 moves inner sleeve 220 within outer housing 210 of cassette 200. Inner sleeve 220 may be sized and shaped to receive syringe 260 therein.

[0022] Continuing with reference to FIG. 4 , the syringe 260 may include a barrel 261 defining a fluid chamber 262. The fluid chamber 262 may be pre-filled with a predetermined dose of a medicinal product 267. The medicinal product 267 may have a viscosity that is dependent on the temperature of the product 267. The syringe 260 may further include an injection needle 265 removably or fixedly disposed at the proximal end of the barrel 261 and an outwardly extending flange 263 disposed at the distal end of the barrel 261. The injection needle 265 may be in communication with the fluid chamber 262 to enable administration of the predetermined dose of medicinal product 267 released from the fluid chamber 262 of the syringe barrel 261. The syringe 260 may further include a movable plunger stopper 264 disposed within the fluid chamber 262 of the barrel 261 for expelling the predetermined dose of medicinal product 267 from the chamber 261 so that the predetermined dose of medicinal product 267 may be dispensed through the injection needle 265. The aforementioned protective needle shield 266 covers the injection needle 265 and may be made of a non-rigid material. In one exemplary embodiment, the syringe 260 may comprise a standard 1 mL glass syringe. The locking cap 230 closes the distal end 224 of the inner sleeve 220 and rigidly secures the proximal end 261P of the syringe barrel 261 against an inner edge formed at the junction of the inner surface of the proximal end wall 222 and the bore 222A of the inner sleeve 220, such that the syringe 260 moves with the inner sleeve 220 as it advances through the outer housing 210 during operation of the autoinjector 300.

[0023] The locking cap 230 shown in FIGS. 5-7 locks the syringe 260 within the inner sleeve 220 with a predetermined force that may be set during assembly of the cassette 200. The locking cap 230 may include a generally flat, annular body 231 having an outer surface 2310 and an inner surface 2311, and opposing arms 232 depending from the body 231 away from the inner surface 2311 of the body 231. Each of the arms 232 may include a notched member 233 with a hooked end 234. In some embodiments, the notched members 233 may be spring-like. The members 233 may extend outward from the arms 232 toward the body 231. The body 231 may be made of metal or a hard plastic material. A soft, elastomeric ring-shaped bumper 235 may be attached to the inner surface 2311 of the body 231. The body 231 and bumper 235 may define an opening 236 that can be dimensioned to allow a plunger rod 342, actuated by a motorized ejection drive 340 ( FIG. 38 ) of the autoinjector 300, to pass through the locking cap 230 and engage the plunger stopper 264 to move the plunger stopper 264 within the fluid chamber 262 of the syringe barrel 261 during operation of the autoinjector 300. The locking cap 230 may be dimensioned to receive the flange 263 of the syringe 260 between the opposing arms 232 of the locking cap 230 in a snug fit, with the bumper 235 engaging the top surface 263T of the flange 263, as shown in FIGS. 6 and 7 . The arms 232 of the locking cap 230 may be inserted into opposing receivers 220R formed at the distal end of the inner sleeve 220 when the syringe 260 is assembled to the inner sleeve 220. The barbs 234 of the arms 232 grip the inner surface of the receivers 220R to lock the locking cap 230 in place, thereby retaining the syringe 260 locked within the inner sleeve 220. The arms 232 of the locking cap 230 may be inserted into the receivers 220R of the inner sleeve 220 a selected distance to limit (to a predetermined value) the amount of force applied to the syringe 260 during assembly into the cassette 200 and during use.

[0024] Figure 8 shows an alternative embodiment of a locking cap designated by reference numeral 230'. Locking cap 230' is similar to locking cap 230 of Figures 5-7, but omits notch member 233 and instead provides a hook formation 234' at the end of each arm 262.

[0025] As shown in FIGS. 9-22 , a spacer 400 can be used within the cassette 200 to allow the injector 100 and its ejection drive 340 and plunger rod 342 to be utilized with various syringe 260 sizes while ensuring proper engagement and ejection of the medication. The spacer 400 can function as an intermediate component between the plunger stopper 264 and plunger rod 342 of the syringe 260, and includes a proximal end 402 configured to engage the plunger stopper 264 and a distal end 404 configured to engage the plunger rod 342. The spacer 400 acts as an adapter, allowing the plunger rod 342 to have a single, reusable size within the autoinjector 300 while allowing the barrel 261 and plunger stopper 264 to be changed in size as desired. The spacer 400 can advantageously reduce the stroke length of the plunger rod 342 to deliver a full dose of medication, thus reducing injection time and reducing the overall length of the autoinjector 300. Thus, when cassette 200 is assembled, spacers 400 can be selected from a number of available spacers (each with a different diameter and, if desired, plunger stopper-engaging portions with other dimensions) to have a diameter that matches the syringe barrel size and plunger stopper size for any given application. Additionally, opposite ends of the various spacers 400 can have a uniform configuration so that all spacers can mate with the same cassette components. The various configurations described herein can also avoid potential operational issues, such as misalignment of the syringe and plunger rod, binding of the plunger rod to the plunger stopper, etc.

[0026] 9 and 10 , the spacer 400 can have a cylindrical body with one or more portions having equal or different diameters configured for various cassette 200 and syringe 260 configurations and sizes. For example, the proximal end 402 has an outer diameter sized so that its end face 406 can properly engage the rear surface 264B ( FIGS. 13 and 15 ) of the plunger stopper 264 so that, when the spacer 400 is pushed by the plunger rod 342, the spacer 400 drives the plunger stopper 264 within the syringe 260 at a desired speed without undesired slippage. In some forms, the proximal end 402 can be sized so that its outer surface 412 can engage the inner surface of the barrel 261. For example, the proximal end 402 can be sized to engage the barrel 261 to resist movement due to mass forces such as gravity and inertia. Preferably, in these configurations, the proximal end 402 may be sized to resist movement due to mass forces, but with minimal or no excessive friction beyond that required to resist movement due to mass forces. Additionally, the exterior surface 412 preferably orients and radially secures the spacer 400 within the barrel 261 by engaging the barrel 261 at points along and / or longitudinally spaced apart from the longitudinal length of the barrel 261. In the illustrated configuration, the exterior surface 412 of the proximal end 402 may include a number of grooves 414 extending the longitudinal length of the proximal end 402 to provide a bypass path for any air or other gas trapped between the spacer 400 and the plunger stopper 264 when the spacer 400 is driven relative to the plunger stopper 264. The grooves 414 may extend longitudinally along the proximal end 402, as shown, may have a helical configuration, or a combination thereof.

[0027] In the illustrated form, the plunger stopper 264 can have a cup-like configuration ( FIGS. 13 and 15 ) defining a rearwardly opening cavity 264A and an annular distal end surface 264B. Thus, in one example, the spacer 400 can have a cavity 408 defining a hollow interior with an opening 410 defined in the end surface 406, giving the end surface 406 and at least a portion of the proximal end 402 an annular configuration. The annular end surface 406 of the proximal end 402 can be sized to engage the distal end surface 264B of the plunger stopper 264. This advantageously eliminates potential challenges between the relative sizes of the plunger rod 342 and the plunger stopper 264, particularly the cavity 264A of the plunger stopper 264.

[0028] As described in more detail below, the distal end 404 of the spacer 400 couples to the cassette 200, thereby securing the spacer 400 in a predetermined position aligned with the plunger stopper 264. For example, the distal end 404 may be configured to press-fit into and engage the sleeve 220, e.g., the locking cap 230, or other component of the locking cap 230, to attach the spacer 400 to the cassette 200. Accordingly, the outer surface 416 of the distal end 404 may be sized to engage an opening in the sleeve 220. For example, the distal end 404 may be configured to engage an inner surface of the locking cap 230 or component, thereby resisting displacement due to mass forces, such as gravity and inertia. Preferably, in these configurations, the distal end 404 may be sized to resist displacement due to mass forces, but with minimal or no excessive friction beyond that required to resist displacement due to mass forces. In the illustrated form, the outer surface 416 of the distal end 404 is provided with a number of radially extending ribs 418 that establish the outer diameter of the distal end 404, thereby minimizing the contact surface between the spacer 400 and the locking cap 203 or component. The ribs 418 can extend longitudinally along the distal end 404, as shown, or can have a helical configuration, or a combination thereof. The ribs 418 can also function to provide vents along the outer surface of the distal end 404. An end face 420 of the distal end 404 is configured to be engaged by the plunger rod 342 and, therefore, can have a configuration complementary to the leading face of the plunger rod 342. For example, the end face 420 can have a concave configuration, as shown.

[0029] 13 and 15 , the cavity 408 of the spacer 400 can extend to an end wall 422 of the distal end 404 to reduce weight and material costs associated with the spacer 400. Additionally, the end wall 422 can include one or more through openings 424. The through openings 424 extend through the end wall 422 and allow air or gas trapped between the spacer 400 and the plunger stopper 264 to exit through the through openings 424 when the spacer 400 is driven relative to the plunger stopper 264.

[0030] In some embodiments, the proximal end 402 and the distal end 404 can be separated by a neck 426 that has a reduced outer diameter relative to the proximal end 402 and the distal end 404. In this configuration, the neck 426 defines an annular space for receiving additional mounting structure, as described in more detail below.

[0031] Advantageously, the locking cap 230 described above can be modified to have a spacer 400 coupled thereto. In these configurations, when the spacer 400 is coupled to the locking cap 230 and the locking cap 230 is secured to the sleeve 220, the spacer 400 is aligned with the barrel 261 and the plunger stopper 264 disposed within the barrel 261.

[0032] In a first configuration, as shown in FIGS. 11-16 , the locking cap 230 may include an annular wall 430. The annular wall 430 extends around the opening 236 and rearwardly from the body 231. The annular wall 430 defines a cylindrical cavity therein for receiving the distal end 404 of the spacer 400. As described above, the distal ends 404 of various spacers may have a uniform configuration so that the same locking cap 230 can be used for spacers 400 having various proximal ends 402. The inner diameter of the annular wall 430 and the outer diameter of the distal end 404 of the spacer 400 may advantageously be sized so that the locking cap 230 and the spacer 400 engage with each other in a press-fit configuration. As shown in FIGS. 15 and 16 , the distal end 404 may be sized so that the end face 420 is at least partially flush with the top of the annular wall 430 when fully inserted within the annular wall 430.

[0033] In this configuration, the cover 250 may include an annular wall 256 extending forward toward the locking cap 230 around the opening 254 to accommodate the increased depth of the locking cap 230 provided by the annular wall 430. The annular walls 430, 256 are preferably sized so that the locking cap 230 and the cover 250 tightly engage with each other when the locking cap 230 and the cover 250 are attached to the sleeve 220. Further, as shown in FIGS. 15 and 16 , the annular walls 430, 256 may be sized so that the end face 420 of the distal end 404 extends to and is flush with the outer surface of the cover 250, e.g., approximately 0-2 mm. Alternatively, the spacer 400 may be configured to engage the annular wall 256 of the cover 250 to couple the spacer 400 to the cassette 200.

[0034] During assembly, this configuration allows a user to select a spacer 400 having dimensions appropriate for the particular plunger stopper 264 and syringe 260 being used in the assembly. The distal end 404 of the spacer 400 can then be press-fit into the opening in the annular wall 430 of the locking cap 230, which can then be coupled to the sleeve 220. Finally, the cover 250 can be attached to the sleeve 220 to complete the sleeve 220 assembly. After assembly, the injector 300 can press the spacer 400 to disengage it from the locking cap 230 during the ejection process. Advantageously, this configuration provides a simplified assembly process and an ejection process that does not generate excess debris. In one example, the locking cap 230 can be made from metal, and the spacer 400 can be made from plastic by any suitable process, such as injection molding.

[0035] In a second, further configuration shown in FIGS. 17-19 , in addition to the annular walls 430, 256, the locking cap 230 can include a gasket 432 that couples to the body 231. The gasket 432 includes a major surface 434 having a flat configuration with a central opening 436 therethrough and a rim 438 extending from curved edge portions 440 opposite the major surface 434. The major surface 434 has an annular configuration with straight edge portions 442 extending between the curved edge portions 440. In this configuration, the gasket 432 can be coupled to the body 231 of the locking cap 230 by a lip 444 of the rim 438 that extends across the opposite edges of the body 231 and by legs 432 that extend between the rim 438 and extend below the straight edge portions 442. Of course, the periphery of the gasket 432 can have any suitable configuration for coupling to the body 231.

[0036] As shown in FIG. 19 , in one example, the diameter of the central opening 436 can be sized to extend into the annular space defined by the neck 426 of the spacer 400, such that at least a portion of the gasket 432 extends between the proximal end 402 and the distal end 404 of the spacer 400. The gasket 432 can be made of a deformable material, such as rubber or plastic, so that the spacer 400 can be forced through the opening 436 by deforming the major surface 434. In one configuration, the edge of the central opening 436 can define a plurality of teeth 446. In this configuration, the gasket 432 can provide a cushion between the locking cap 230 and the sleeve 220 and absorb vibrations during shipping or accidental dropping. The gasket 432 can also reduce the risk of breakage of the glass syringe.

[0037] In a third configuration, shown in FIGS. 20-22 , an overmolded member 450 may be coupled to the body 231, the overmolded member 450 including an annular upstanding wall 452 and a flange 454 extending outward from a lower edge of the wall 452. In the configuration shown, the flange 454 extends along the inner surface of the body 231 and includes a connecting post 456 extending through an opening in the body 231. As with the previous configurations, the inner diameter of the wall 452 may be sized to receive the distal end 404 of the spacer in a press-fit configuration. If desired, in some examples, the wall 452 may further include inwardly extending teeth 458 configured to be inserted into the neck 426 of the spacer 400 and deformed during ejection, as described above. The teeth 458 may be provided within undercuts 460 formed in the wall 452, as shown.

[0038] As shown in FIGS. 23 and 24 , the sleeve 220 can also be modified to accommodate syringes 260 of various sizes while having a uniform outer dimension and configuration so that the same outer housing 210 and injector 300 can be used with the sleeve 220 and syringe 260. Accordingly, the sleeve 220 can include one or more interior walls or ribs 500 defining a mounting surface 502 for receiving the syringe 260. For example, the sleeve 220 can include a number of ribs 500, such as three, four, five, or more as shown, distributed radially inside the sleeve 220, which cooperate to form a diameter suitable for supporting and positioning the syringe 260 within the sleeve 220. The radial lengths of the ribs 500 can be varied to accommodate syringes 260 having various diameters. The ribs 500 support the syringe 260 without imparting linear or rotational motion to the syringe 260. In this configuration, the sleeve 220 is limited only by the dimensions of one or more outer walls 504 in terms of the sizes of syringes 260 that the system can accommodate. The sleeve 220 may also include an identifier 506 on the exterior of the sleeve 220 that allows a user to easily identify and select the desired size of a particular syringe 260 during assembly. The sleeve 220 may be formed by any suitable process, such as injection molding. In one example, interchangeable cores may be used with a common outer mold during the injection molding process to create ribs 500 having various dimensions.

[0039] It will be appreciated that the configurations described herein may be used in conjunction with sleeve 220 and housing 210 to form a portion of cassette 200. Additionally, cassette 200 having spacer 400 therein may be inserted into auto-injector 300 as described herein. Thus, during a drug ejection operation, plunger rod 342 may be driven longitudinally within auto-injector 300, engaging spacer 400, driving spacer 400 within barrel 261 and engaging plunger stopper 264, which may then be driven within barrel 261 to eject a dose of drug from syringe 260.

[0040] 25 and 26, the outer housing 210 of the cassette 200 may include a cassette identification configuration that provides information that identifies the cassette 200, such as information regarding the contents of the syringe 260 housed within the cassette 200 and / or other cassette / syringe characteristics. In an exemplary embodiment, the cassette identification configuration may include one or more ridges or protrusions 210P on the bottom surface 210B of the outer housing 210 of the cassette 200. The protrusions 210P may be sensed by or engage a detector (not shown) within the autoinjector 300 when the cassette 200 is inserted into the door 308 of the autoinjector 300 and the door 308 is closed. The detector 370 may be electrically coupled to a microprocessor housed within the autoinjector 300 (e.g., microprocessor 350 shown in FIG. 33), thereby enabling the autoinjector 300 to read the cassette identification configuration and thereby identify the cassette 200. In one exemplary embodiment, a predetermined number of protrusions 210P may be located at predetermined locations on the bottom surface 210B of the outer housing 210, and the detector 370 may include a keypad (not shown) with multiple keys. A specific key among the multiple keys may be activated by the cassette protrusions 210P when the cassette 200 is inserted into the autoinjector 300, depending on the location and number of the protrusions 210P. Each key activated by one of the protrusions 210P may provide information that allows the autoinjector 300 to identify the cassette 200. In some embodiments, the cassette identification configuration identifies the drug delivery profile of the medication provided in the cassette 200. Thus, upon insertion and recognition of a valid cassette and recognition of the information provided by the cassette identification configuration, the autoinjector 300 may automatically register available preset drug discharge rate ranges corresponding to the drug delivery profile of the medication provided in the cassette 200. The available rate ranges depend on the syringe fill volume and medication properties, such as viscosity.For example, and without limitation, if the cassette identification configuration includes multiple protrusions 210P, one protrusion may indicate a 1 mL fill, two protrusions may indicate a 0.5 mL fill, and additional protrusions may be provided to identify the drug and / or drug characteristics.

[0041] 26 also shows a latching mechanism 218 that may be provided on the bottom wall 210B of the outer housing 210 of the cassette 200. The latching mechanism 218 may include a pair of resilient locking arms 218a, 218b extending parallel to one another. The locking arms 218a, 218b may define locking detent slots 219a, 219b, respectively. When the syringe 260 is in a home position with the injection needle 265 of the syringe 260 hidden within the cassette 200 in the needle-hiding position, the pin 268 of the inner sleeve 220 may engage with the detent slots 219a, 219b of the latching mechanism 218, thereby locking or latching the inner sleeve 220 in place within the outer housing 210 of the cassette 200. During an injection cycle, the insertion drive 330 (FIG. 33) of the autoinjector 300 spreads the resilient locking arms 218a, 218b apart, unlatching or releasing the inner sleeve pin 268 from the detent slots 219a, 219b of the latching mechanism 218, thereby allowing the unlocked inner sleeve 220 housing the syringe 260 to be freely moved by the insertion drive 330, which pushes the inner sleeve pin 268 to move the inner sleeve 220 relative to the outer housing 210 from a home position with the injection needle 265 in the needle-hidden position to an injection position with the injection needle 265 in the needle-extended position allowing the injection needle 265 to penetrate the skin at the injection site. At the end of the injection cycle, the insertion drive 330 pulls the inner sleeve pin 268 back into the detent slots 219a, 219b, thereby returning the inner sleeve 220 (containing the syringe 260) to its home position with the injection needle 265 in the needle-hidden position.

[0042] Cassettes of similar structure and operation are described in detail in the following patent applications: U.S. Patent Application Publication Nos. 2009 / 0292246 and 20100022955, and WO 2009 / 143255, each of which is incorporated herein by reference in its entirety.

[0043] 2-4 , cover 250 is attached to the distal end of outer housing 210 of cassette 200 to close the distal end of cassette 200. Cover 250 may be a generally planar member having a shape that matches the shape of distal end 216 of outer housing 210. Cover 250 may include two or more locking arms 253 that extend from an interior surface 251 of cover 250 and lockingly engage corresponding receivers 255 that extend through sidewall 211 of outer housing 210. Additionally, any detent structure or other suitable locking configuration (not shown) formed in, on, or through outer housing 210 adjacent distal end 216 of outer housing 210 may be used to attach cover 250. Cover 250 may further include an opening 254 axially aligned with opening 236 defined by locking cap 230. Opening 254 in cover 250, like opening 236 in locking cap 230, may be dimensioned to allow a plunger rod 342, actuated by a motorized ejection drive 340 (FIG. 33) of autoinjector 300, to pass through cover 250 and engage plunger stopper 264 to move plunger stopper 264 within fluid chamber 262 of syringe barrel 261 during operation of autoinjector 300.

[0044] 27-32, autoinjector 300 may include a casing 302 having a handle portion 304 and a cassette receiving section 306 aligned with handle portion 304. To assist patients with dexterity challenges, handle portion 304 of autoinjector casing 302 may define an ergonomically shaped handle 305 having a soft grip area 305S. Cassette receiving section 306 includes cassette door 308 (FIGS. 28 and 30). In the open position (FIG. 1), the cassette door receives cassette 200 and aligns it with the insertion and ejection drives, and in the closed position, aligns it with other structures and components of autoinjector 300. Cassette door 308 may include a "cassette" icon indicating the insertion entry point for cassette 200. The cassette-receiving section 306 of the casing 302 may include windows 310A, 310B on opposite sides thereof that align with the window 212 ( FIG. 3 ) of the cassette 200 when the cassette door 308 is closed with the cassette 200 properly installed therein. In one or more embodiments, the windows 310A, 310B may be dual-layered. One or more lights (not shown) may be provided within the casing 302 to uniformly backlight the cassette window 212 and the syringe 260 disposed within the internal sleeve 220 of the cassette 200 so that a user can observe the injection cycle through the windows 310A, 310B of the autoinjector 300, i.e., the initial and final positions of the plunger stopper 264 of the syringe 260 during the syringe's movement within the cassette 200 as well as during the syringe contents (hereinafter, “drug”) ejection process.

[0045] 27, 28, 30, and 32, autoinjector 300 may further include a user interface 312 and an audio speaker (not shown). User interface 312 (best shown in FIG. 27) may be located in cassette-receiving section 306 of casing 302 and provide various visual indicators. An audio speaker may be disposed within casing 302 and provide various audible indicators. The audio speaker may audibly communicate with the external environment through a speaker opening 314 formed in cassette-receiving section 306 of casing 302. The visual and audible indicators produced by user interface 312 and audio speaker may inform the user of the progress of the injection process, completion of injection, the occurrence of any errors, and other information when autoinjector 300 is ready for use. The autoinjector 300 may further include one or more of a set / mute switch 315, a speed select switch 316, a start button 307, and an eject button 317. The set / mute switch 315 (FIG. 28) may be located in the cassette receiving section 306 of the casing 302. The mute switch 315 may allow a user to turn all synthesized sounds, except error sounds, on and off and may be fabricated and adapted to respond in real time so that the sounds are immediately muted when the user begins the injection process and turns the mute switch off. The mute switch 315 may also be fabricated and adapted to slide toward a "mute" icon to mute the audio speaker. A light indicator may be provided to confirm the "mute" state. The speed select switch 316 (FIGS. 27 and 28) may be located in the cassette receiving section 306 of the casing 302. The speed select switch 316 may be fabricated and adapted to allow a user to select from multiple preset drug delivery (excretion) rates to accommodate individual patient preferences. The speed select switch 316 may include three switch positions. Other embodiments of the speed select switch may include two switch positions or four or more switch positions.In yet other embodiments, the rate selector switch may be infinitely variable. In some embodiments, changing the position of the switch 316 before injection changes the drug output rate during injection, while changing the position of the rate selector switch 316 during injection does not change the injection rate in real time. The autoinjector 300 may also include one or more demo cassettes to allow the user to experiment with different rates of drug delivery. A start button 307 at the free end of the handle 305. The button 307 may include an indentation 3071 to optimize thumb placement on the button 307. The button 307 may be made of a translucent material to allow lighting effects to illuminate the button as a signal. An eject button 317 (FIG. 30) may be located in the cassette-receiving section 306 of the casing 302. The eject button 317 may include an indentation 3171 to optimize finger placement on the button 317. In some embodiments, the eject button 317 may be controlled by a microprocessor of the autoinjector 300 (e.g., microprocessor 350 shown in FIG. 33), which may be programmed to eliminate accidental input during the injection process.

[0046] 31 , cassette receiving section 306 and cassette door 308 of casing 302 may form a proximal end wall 318 of autoinjector 300. Proximal end wall 318 may be configured as a wide, flat, and stable base for easily placing autoinjector 300 on a support surface after removal of shield remover 240 or when autoinjector 300 does not contain cassette 240. The portion of proximal end wall 318 formed by cassette door 308 may include aperture 308A sized and shaped to allow shield remover 240 to be removed from cassette 200 and ejected through aperture 308A when cassette 200 is installed in autoinjector 300. Once shield remover 240 passes through hole 308A, tongue 245T of expandable partial collar structure 245 expands or flares outward, thereby preventing shield remover 240 and attached needle shield 266 from being reinserted through hole 308A in cassette door 308. The proximal end wall of autoinjector 300 may further include target light 320. Target light 320 may be constructed and adapted to activate when shield remover 240 is removed from cassette 200 and ejected through hole 308A, thereby providing a visual indication that shield remover 240 has been removed. When activated, the target light assists the user in visualizing and selecting an injection site.

[0047] 33 shows a side cross-sectional view of autoinjector device 100, including autoinjector 300 and cassette 200 installed therein. Casing 302 of autoinjector 300 may house chassis 301 for receiving cassette 200 containing syringe 260, motorized insertion drive 330, motorized ejection drive 340, microprocessor 350 (described above), battery 360 for powering drives 330, 340 and microprocessor 350, and skin sensor 380 (described above).

[0048] Microprocessor 350 may be programmed with specific instructions that, when executed by microprocessor 350, allow it to control and monitor various operations and functions of autoinjector 300. For example, without limitation, the microprocessor may be programmed with instructions to control motorized insertion drive 330 and ejection drive 340 so that the microprocessor controls and monitors each step of the injection cycle and process flow, thereby automating needle insertion, drug ejection, and needle retraction and ensuring accurate, consistent, and reliable operation of autoinjector 300 and medication administration. The microprocessor may also be programmed with instructions to control audible and visual feedback to the user. An automatic power-on self-test verifies the operation and remaining battery charge of autoinjector 300.

[0049] Referring again to FIG. 33 , the motorized insertion drive 330 performs needle insertion and retraction cycles. FIGS. 34 and 35 show top-down and bottom-up side perspective views, respectively, of an embodiment of the motorized insertion drive 330. The insertion drive 330 may include an insertion drive motor 331, a drive link or rack 332, and an insertion drive gear train 333 including a plurality of gears 3331, 3332, 3333, and 3334 for transmitting the rotational motion of the insertion drive motor 331 to drive the rack 332. The rack 332 may include a top surface 332T and a bottom surface 332B. The top surface 332T of the rack 332 may include first and second spaced-apart protrusions 3321 and 3322, respectively. The bottom surface 332B of the rack 332 may include rack teeth 334. Rack teeth 334 of the rack engage gears 3334 of gear train 333. During a needle insertion cycle, a first protrusion 3321 of rack 332 unlatch an inner sleeve pin 268 of the inner sleeve 220 of cassette 200 from a latch 218 of the outer cassette housing 210 (FIG. 26), and then engages and pushes the inner sleeve pin 268, driving the inner sleeve 220 containing the syringe 260 forward within the outer housing of cassette 200 from a home position to a needle extended position where the infusion needle 265 of the syringe 260 extends from the cassette 200 and is inserted into the skin at the infusion site. During the needle retraction cycle, the second protrusion 3322 of the rack 332 engages the inner sleeve pin 268, which then pulls on the inner sleeve pin 268, driving the inner sleeve 220 containing the syringe 260 back into position within the outer housing of the cassette 200, thereby withdrawing the injection needle 265 of the syringe 260 from the skin at the injection site and (after drug expulsion) retracting the injection needle 265 back into the cassette 200, where it is secured and locked for safe handling and disposal. Needle insertion positioning and timing are monitored and controlled by the autoinjector's microprocessor 350. If an error occurs, the error is displayed on the user interface 312 (FIG. 27) along with an audible alarm from the speaker.The insertion drive 330 enables the autoinjector device 100 to deliver medication subcutaneously (SC) to a predetermined needle injection depth. This needle depth parameter is achieved when the insertion drive 330 moves the inner sleeve 220 / syringe 260 forward to a hard mechanical stop within the outer housing 210 of the cassette 200. The hard mechanical stop limits the movement of the syringe 260 toward the patient's skin, ensuring the desired needle depth meets the predetermined specifications. Monitoring the movement of the motor 331 allows for the detection of incomplete needle insertion, which triggers needle retraction and termination of the injection cycle, accompanied by audible and visual alarms.

[0050] The motorized ejection drive 340 shown in FIG. 33 performs a drug ejection cycle in which the medication is ejected and the syringe 260 is emptied. FIGS. 36 and 37 are side perspective views of an embodiment of the motorized ejection drive 340. FIG. 36 shows an exploded side perspective view of an embodiment of the plunger rod / drive screw configuration of the motorized ejection drive 340. FIG. 37 shows an assembled side perspective view of the plunger rod / drive screw configuration shown in FIG. 36. FIG. 38 shows a perspective view of an embodiment of the gear train of the motorized insertion drive 330. The ejection drive 340 may include an ejection drive motor 341, a plunger rod 342, a lead screw 343, and an ejection drive gear train 344. The plunger rod 342 is driven by the ejection drive motor 341 via the lead screw 343 and the ejection drive gear train 344. As shown in FIGS. 36 and 37, the plunger rod 342 may include a pusher 342P, and the lead screw 343 may include a nut 345. A nut 345 mechanically couples the plunger rod 342 to the lead screw 343. The nut 345 may include internal threads 345T that threadably engage with the external threads 343T of the lead screw 343. The nut 345 may also include a holder 345H that firmly holds the pusher 342P of the plunger rod 342. As shown in FIG. 38 , the ejection drive gear train 344 may include multiple gears 3441, 3442, 3443, 3444, 3445, and 3446. The gears 3441 and 3446 of the ejection drive gear train 344 are coupled to the ejection drive motor 341 and the lead screw 343, respectively, thereby allowing the ejection drive gear train 344 to transmit the rotational motion of the insertion drive motor 331 to drive the lead screw 343. As lead screw 343 rotates, nut 345 (which is threadedly engaged with lead screw 343) moves forward or backward along lead screw 343 (depending on the direction of rotation of the lead screw), and nut 345 drives plunger rod 342 forward and backward within autoinjector 300. By moving plunger rod 342 forward, end face 342EF of plunger rod 342 enters cassette 200 and then syringe barrel 261 of syringe 260.The plunger rod 342 then engages the plunger stopper 264 of the syringe 260 and presses the plunger stopper 264 against the end of the syringe barrel 261 to expel a predetermined dose of medication from the syringe 260 during a drug ejection cycle. The microprocessor 350 may monitor the position of the ejection drive 340 components, as well as the time associated with drug ejection. If an error occurs, the error may be displayed on the user interface 312 along with an audible alarm. The microprocessor 350 may be capable of storing different drug delivery profiles (stroke, velocity, acceleration) set at the factory. Multiple unique drug delivery profiles may be associated with a particular cassette configuration. Cassette identification features on the external housing 210 of the cassette 200 enable the autoinjector 300 to identify a suitable drug delivery profile specific to the loaded medication. Upon insertion and recognition of a valid cassette 200, available preset drug ejection rate ranges may be automatically registered by the autoinjector 300. The range of speeds available depends on the syringe fill volume and the properties of the pharmaceutical product, such as viscosity.

[0051] The user may select the desired drug ejection rate (defined as the time it takes to eject the drug and empty the syringe 260) from several different options for a particular drug using the rate select switch 316. At the start of a drug ejection cycle, the stroke of the plunger rod 342 may be controlled and monitored to ensure that the plunger stopper 264 reaches the end of the syringe barrel 261, thereby ensuring a full dose. If an error occurs during the ejection process (e.g., the plunger rod fails to achieve a full stroke), the autoinjector 300 may immediately terminate ejection of the drug, retract the needle into the cassette 200, and provide audible and visual alarms.

[0052] The injection cycle may be indicated by both audible and visual signals. The lights on the autoinjector 300 may be turned off in sequence from top to bottom during the injection cycle to indicate the progress of the injection to the user. Upon completion of the injection cycle, the autoinjector 300 retracts the syringe needle back into the disposable cassette 200 and then automatically opens the cassette door 308, allowing the user to remove the cassette 200. The opening of the cassette door 308 may also be an indicator to the user that the injection cycle is complete.

[0053] If an error occurs during an injection cycle, the autoinjector 300 may be equipped with various audible and visual signals to notify the user (operator or patient) of the error and prompt appropriate action.

[0054] The battery 360 shown in FIG. 33 may be a non-replaceable, non-rechargeable battery. Alternatively, the battery 360 may be a replaceable and / or rechargeable battery. The battery 360 should be capable of providing sufficient power for a suitable life and service life to meet drug delivery requirements. A power-on self-test is automatically performed upon activation of the autoinjector 300 to ensure sufficient battery power is available for a successful injection cycle. The user interface 312 of the autoinjector 300 may provide visual and audible alerts if a problem occurs with the battery 360 prior to injection. The microprocessor 350 may be programmed to disable the autoinjector 300 at the end of its specified service life or if the battery 360 does not have enough charge to perform a successful injection cycle.

[0055] The above description describes various devices, assemblies, components, subsystems, and methods of use related to drug delivery devices. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include or be used in conjunction with drugs, including, but not limited to, the drugs identified below and their generic and biosimilar equivalents. As used herein, the term drug may be used interchangeably with other similar terms and may refer to any type of pharmaceutical or therapeutic material, including traditional and non-traditional medicines, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0056] The drug is contained in a reservoir. In some cases, the reservoir is a primary container that is either filled or pre-filled with the drug for treatment. The primary container can be a vial, cartridge, or pre-filled syringe.

[0057] In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, a colony-stimulating factor such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF formulations include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-Met-G-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006, pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0058] In other embodiments, the drug delivery device may contain or be used in conjunction with an erythropoiesis-stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates red blood cell production. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, "erythropoiesis-stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoiesis-stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate the erythropoietin receptor, antibodies that bind to and activate the erythropoietin receptor, or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis-stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), and Binocrit® (epoetin alfa). Epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and molecules or variants or analogs thereof.

[0059] Among certain exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants, or derivatives thereof: OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, and related proteins, including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, and related proteins, including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, and related proteins, particularly those that inhibit activities mediated by binding of IL-4 and / or IL-13 to their receptors. Interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptibodies, related proteins, etc.; Ang2 specific antibodies, peptibodies, related proteins, etc.; NGF specific antibodies, peptibodies, related proteins, etc.; CD22 specific antibodies, peptibodies, related proteins, etc., especially dimers of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain, e.g., the human form of epratuzumab (CAS Registry Number 501423-23-0). Human CD22-specific antibodies, including but not limited to, humanized and fully human antibodies, including but not limited to, humanized and fully human monoclonal antibodies, particularly including but not limited to, human CD22-specific IgG antibodies, such as CD22-specific fully humanized antibodies; IGF-1 receptor-specific antibodies, peptibodies, and related proteins, including but not limited to, anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptibodies, and related proteins (also referred to as "B7RP-1," B7H2, ICOSL, B7h, and CD275), including but not limited to, those that inhibit the interaction of B7RP-1 with ICOS, the natural receptor for B7RP-1 on activated T cells, including but not limited to, a B7RP-specific fully human monoclonal IgG2 antibody that binds to an epitope in the first immunoglobulin-like domain of B7RP-1; HuMax, e.g., 145c7 IL-15 specific antibodies, peptibodies, related proteins, etc., including, but not limited to, IL-15 antibodies and related proteins, particularly humanized monoclonal antibodies; human IFNIFN-γ-specific antibodies, peptibodies, related proteins, etc., including but not limited to, IFN-γ-specific antibodies, and fully human anti-IFN-γ antibodies; TALL-1-specific antibodies, peptibodies, related proteins, etc., and other TALL-specific binding proteins; parathyroid hormone ("PTH")-specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor ("TPO-R")-specific antibodies, peptibodies, related proteins, etc.; and those targeting the hepatocyte growth factor / scatter factor (HGF / SF:c-Met) axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize HGF / SF. including, hepatocyte growth factor ("HGF")-specific antibodies, peptibodies, related proteins, etc.; TRAIL-R2-specific antibodies, peptibodies, related proteins, etc.; activin A-specific antibodies, peptibodies, proteins, etc.; TGF-β-specific antibodies, peptibodies, related proteins, etc.; amyloid β protein-specific antibodies, peptibodies, related proteins, etc.; c-Kit-specific antibodies, peptibodies, related proteins, etc., including, but not limited to, proteins that bind to c-Kit and / or other stem cell factor receptors; OX40L-specific antibodies, peptibodies, related proteins, etc., including, but not limited to, proteins that bind to X40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA), Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel erythropoiesis-stimulating protein (NESP), Epogen (R) (epoetin alfa, or erythropoietin), GLP-1, Avonex® (interferon beta-1a), Bexxar® (tositumomab, an anti-CD22 monoclonal antibody), Betaseron® (interferon-beta), Campath® (alemtuzumab, an anti-CD52 monoclonal antibody), Dynepo® (epoetin delta), Velcade® (bortezomib), MLN0002 (anti-alpha4beta7mAb), MLN1202 (anti-CCR2 chemokine receptor mAb), Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Eprex® (epoetin alfa), Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1), Genotropin® (somatropin, human growth hormone), Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb), Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of Herceptin® or another product containing trastuzumab for the treatment of breast cancer or gastric cancer, Humatrope® (somatropin, human growth hormone), Humira® (adalimumab), (panitumumab), Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution, Infergen® (interferon alfacon-1), Natrecor® (nesiritide, recombinant human B-type natriuretic peptide (hBNP)), Kineret® (anakinra), Leukine® (sargamostim, rhuGM-CSF), LymphoCide® (epratuzumab, anti-CD22 mAb), Benlysta™ (lymphostat B, belimumab, anti-BlySmAb), Metalyse® (tenecteplase, t-PA analog), Mircera® (methoxypolyethylene glycol-epoetin beta), Mylotarg® (gemtuzumab ozogamicin), Raptiva® (efalizumab), Cimzia® (certolizumab pegol, CDP870), Soliris™ (eculizumab), pexelizumab (anti-complement C5), Numax® (MEDI-524), Lucentis® (ranibizumab), Panorex® (17-1A, edrecolomab), Trabio® (lerdelimumab), TheraCim hR3 (nimotuzumab), Omnitarg (pertuzumab, 2C4), Osidem® (IDM-1), OvaRex® (B43.13), Nuvion® (vigilizumab), cantuzumab mertansine (huC242-DM1), NeoRecormon® (epoetin beta), Neumega® (oprelvekin, human interleukin-11), Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody), Procrit® (epoetin alfa), Remicade® (infliximab, anti-TNFα monoclonal antibody), Reopro® (abciximab, anti-GP IIb / IIia receptor monoclonal antibody), Actemra® (anti-IL6 receptor mAb), Avastin® (bevacizumab), HuMax-CD4 (zanolimumab), Mvasi™ (bevacizumab-awwb), Rituxan® (rituximab, anti-CD20mAb), Tarceva® (erlotinib), Roferon-A® (interferon alpha-2a), Simulect® (basiliximab), Prexige® (lumiracoxib), Synagis® (palivizumab), 145c7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507), Tysabri® (natalizumab, anti-alpha4 integrin mAb), Valortim® (MDX-1303, anti-anthrax protective antigen mAb), ABthrax™, Xolair® (omalizumab), ETI211 (anti-MRSA mAb), IL-1 trap (the Fc portion of human IgG1 and the extracellular domains of both IL-1 receptor components (type I receptor and receptor accessory protein)), VEGF trap (VEGFR1 Ig domain fused to IgG1 Fc), Zenapax® (daclizumab), Zenapax® (daclizumab, anti-IL-2Rα mAb), Zevalin® (ibritumomab tiuxetan), Zetia® (ezetimibe), Orencia® (atacicept, TACI-Ig), anti-CD80 monoclonal antibody (galiximab), anti-CD23 mAb (lumiliximab), BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist), CNTO148 (golimumab, anti-TNFα mAb), HGS-ETR1 (mapatumumab, human anti-TRAIL receptor-1 mAb), HuMax-CD20 (ocrelizumab, anti-CD20 human mAb), HuMax-EGFR (zalutumumab), M200 (volociximab, anti-α5β1 integrin mAb), MDX-010 (ipilimumab, anti-CTLA-4 mAb, and VEGFR-1 (IMC-18F1), anti-BR3 mAb, anti-Clostridium difficile toxin A and toxin BC mAb MDX-066 (CDA-1) and MDX-1388), anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015), anti-CD25 mAb (HuMax-TAC), anti-CD3 mAb (NI-0401), adecatumumab, anti-CD30 mAb (MDX-060), MDX-1333 (anti-IFNAR), anti-CD38 mAb (HuMaxAnti-CD38), anti-CD40L mAb, anti-Cripto mAb, anti-CTGF-Idiopathic Pulmonary Disease Stage 1 Follicular Genome (FG-3019), anti-CTLA4 mAb, anti-eotactic-signal 1 mAb (CAT-213), anti-FGF8 mAb, anti-GD2 mAb, anti-GM2 mAb, anti-GDF-8 receptor mAb (MYO-029), anti-GM-CSF receptor mAb (CAM-3001), anti-HepC mAb (HuMax HepC), anti-IFNα mAb (MEDI-545, MDX-198), anti-IGF1R mAb, anti-IGF-1R mAb (HuMax-Inflam), anti-IL12 mAb (ABT-874), anti-IL12 / IL23 mAb (CNTO1275), anti-IL13 mAb (CAT-354), anti-IL2Ra mAb (HuMax-TAC), anti-IL5 receptor mAb, anti-Ig receptor mAb (MDX-018, CNTO95), anti-IP10 ulcerative colitis mAb (MDX-1100), BMS-66513, anti-mannos receptor / hCGβ mAb (MDX-1307), anti-metastatic dsFv-PE38 conjugate (CAT-5001), anti-PD1 mAb (MDX-1106 (ONO-4538)), anti-PDGFRα antibody (IMC-3G3), anti-TGFβ mAb (GC-1008), anti-TRAIL receptor-2 mAb (HGS-ETR2), anti-TWEAK mAb, anti-VEGFR / Flt-1 mAb, and anti-ZP3 mAb (HuMax-ZP3).

[0060] In some embodiments, the drug delivery device may contain or be used in conjunction with a sclerostin antibody, such as, but not limited to, romosozumab, brosozumab, BPS804 (Novartis), Evenity™ (romosozumab-aqqg), or another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing; or, in other embodiments, a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used in conjunction with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including, but not limited to, OncoVEX GALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain, or be used in conjunction with, an endogenous tissue inhibitor of metalloproteinases (TIMP), such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may contain, or be used in conjunction with, Aimovig® (erenumab-aooe), an anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraines. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab, and bispecific antibody molecules that target the CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure.Additionally, bispecific T cell engager (BiTE®) antibodies, such as, but not limited to, BLINCYTO® (blinatumomab), can be used in or with the drug delivery devices of the present disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with an APJ large molecule agonist, such as, but not limited to, apelin or an analog thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with Avsola™ (infliximab-axxq), an anti-TNFα monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used in conjunction with Kyprolis® (carfilzomib), (2S)—N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used in conjunction with Parsabiv™ (etelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) undergoing hemodialysis. In some embodiments, the drug delivery device may contain or be used in conjunction with ABP798 (rituximab), a biosimilar candidate for Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with a VEGF inhibitor, such as a non-antibody VEGF inhibitor, and / or a VEGF trap, such as aflibercept (fused to Ig domain 2 of VEGFR1 and Ig domain 3 of VEGFR2, Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used in conjunction with ABP959 (eculizumab), a biosimilar candidate for Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used in conjunction with rozivacsp alfa (formerly AMG570), a novel bispecific antibody-peptide conjugate that simultaneously inhibits the activity of ICOSL and BAFF. In some embodiments, the drug delivery device may contain or be used in conjunction with omecamtiv mecarbil (a small molecule selective cardiac myosin activator) or a myotrope (which directly targets the cardiac contractile machinery) or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotorasib (formerly known as AMG510), a KRAS inhibitor. G12C Small molecule inhibitors, or KRAS G12CThe drug delivery device may contain or be used in conjunction with another product containing a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG714, a human monoclonal antibody that binds interleukin-15 (IL-15), or a human monoclonal antibody that binds interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used in conjunction with AMG890, a small interfering RNA (siRNA) that lowers lipoprotein(a), also known as Lp(a), or a small interfering RNA (siRNA) that lowers lipoprotein(a). In some embodiments, the drug delivery device may contain or be used in conjunction with ABP654 (a human IgG1 kappa antibody), a biosimilar candidate for Stelara®, or another product containing a human IgG1 kappa antibody and / or binding to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used in conjunction with Amjevita™ or Amgevita™ (formerly ABP501) (a monoclonal antibody anti-TNF human IgG1), a biosimilar candidate for Humira®, or another product including a human monoclonal antibody anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG160, or another product including a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA)xanti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG119 or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy.In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG119, or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG133, or a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG171, or a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG176, or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG199, or a half-life extended (HLE) bispecific T cell derivative construct (BiTE®). In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG256, an anti-PD-1xIL21 mutein and / or an IL-21 receptor agonist designed to selectively turn on the interleukin-21 (IL-21) pathway in programmed cell death-1 (PD-1)-positive cells. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG330, an anti-CD33xanti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG404, a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG427, a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3)xanti-CD3 BiTE® (bispecific T cell derivative) construct.In some embodiments, the drug delivery device may contain or be used in conjunction with AMG430, or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG506, or another product containing a multispecific FAPx4-1BB-targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG509, or another product containing a bivalent T cell derivative and engineered using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG562, or another product containing a half-life extended (HLE) CD19xCD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with efabaleukin alfa (formerly AMG592), or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG596 or another product containing a CD3x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell derivative) molecule. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG673 or another product containing a half-life extended (HLE) anti-CD33x anti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG701 or another product containing a half-life extended (HLE) anti-B cell maturation antigen (BCMA)x anti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG757 or another product containing a half-life extended (HLE) anti-delta-like ligand 3 (DLL3)x anti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG910 or another product containing the half-life extended (HLE) epithelial cell tight junction protein claudin 18.2xCD3 BiTE® (bispecific T cell derivative) construct.

[0061] Although the drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, they are not limited to the exemplary embodiments. The detailed description should be construed as merely exemplary and does not describe every possible embodiment of the present disclosure. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, and such embodiments will still fall within the scope of the claims that define the invention disclosed herein.

[0062] Those skilled in the art will appreciate that numerous modifications, variations, and combinations can be made to the above-described embodiments without departing from the spirit and scope of the invention disclosed herein, and that such modifications, variations, and combinations are to be construed as being within the scope of the inventive concept.

Claims

1. 1. A cassette for a drug delivery device, comprising: a sleeve having a proximal end and a distal end with an opening; a syringe disposed within the sleeve, the syringe including a barrel having a distal opening coaxially aligned with the opening at the distal end of the sleeve; a plunger stopper slidably disposed within the barrel; a spacer having a proximal end and a distal end, the distal end configured to be inserted into the opening at the distal end of the sleeve to couple the spacer to the sleeve, the distal end of the spacer adapted to be engaged by a plunger rod of a drive mechanism to separate the spacer from the sleeve, slide the spacer within the barrel, and engage the plunger stopper with the proximal end of the spacer, the spacer further including a neck portion disposed between the proximal end and the distal end and having a reduced diameter relative to the proximal end and the distal end to define a space between the proximal end and the distal end; Including, the sleeve further includes (a) an annular wall extending around the opening, the distal end of the spacer configured to engage an inner surface of the annular wall, and (b) a locking cap configured to secure the syringe within the sleeve, the opening of the sleeve being defined by a portion of the locking cap extending over the distal opening of the barrel such that the spacer is configured to couple to the locking cap, the portion of the locking cap including a generally planar body, the annular wall being integral with the body, the locking cap further including a gasket configured to couple to the body with a major surface of the gasket extending along an inner surface of the body, the major surface defining an opening configured to be coaxially aligned with the opening in the body, and the distal end of the spacer configured to be inserted through the opening in the gasket. cassette.

2. 2. The cassette of claim 1, wherein the opening in the gasket has a diameter sized such that a portion of the major surface extends into the space between the proximal and distal ends of the spacer.

3. 3. The cassette of claim 2, wherein the gasket includes teeth aligned about and extending radially into the opening defined in the major surface, the teeth extending at least partially into a space between the proximal and distal ends of the spacer.

4. 4. The cassette of claim 1, wherein the gasket includes one or more rims extending away from the major surface, the rims including lips configured to engage the body and couple the gasket to the body.

5. 5. The cassette of claim 1, further comprising a cover configured to couple to the sleeve near the distal end, the locking cap positioned proximal to the cover, the cover including an opening therethrough and an annular wall extending around the opening and in a proximal direction, the annular wall of the cover extending around the annular wall of the locking cap.

6. (a) the locking cap includes a tubular member having the annular wall and a generally planar body having an annular configuration, the tubular member being coupled to the body by the annular wall extending into the body, and the tubular member including a flange extending along the body, the body and the tubular member being overmolded together, a connecting post of the tubular member extending from the flange through an opening in the body; and / or 2. The cassette of claim 1, wherein (b) the tubular member includes one or more protrusions extending radially inward from the annular wall, the protrusions being sized to extend at least partially into a space between the proximal and distal ends of the spacer.

7. 7. The cassette of claim 1, wherein the proximal end of the spacer has (a) a diameter approximately equal to the diameter of the plunger stopper, and / or (b) one or more grooves extending along an outer surface of the proximal end of the spacer.

8. 8. The cassette of claim 1, wherein the distal end of the spacer (a) includes a plurality of ribs extending radially outward from the distal end of the spacer, the plurality of ribs providing an outer diameter of the distal end for frictionally engaging the locking cap, and / or (b) is configured to be flush with the distal end face of the sleeve when the spacer is coupled to the sleeve.

9. 9. The cassette of claim 1, wherein the spacer has a cup-like configuration having a distal end wall and a cavity having an opening through the proximal end, the distal end wall defining one or more vent openings through the distal end wall.

10. 10. The cassette of claim 1, further comprising: (a) an outer housing configured to movably receive the sleeve and the syringe; and / or (b) a therapeutic product within the syringe.

11. 1. A cassette for a drug delivery device, comprising: a sleeve having a proximal end and a distal end with an opening; a syringe disposed within the sleeve, the syringe including a barrel having a distal opening coaxially aligned with the opening at the distal end of the sleeve; a plunger stopper slidably disposed within the barrel; a spacer having a proximal end and a distal end, the distal end configured to be inserted into the opening at the distal end of the sleeve to couple the spacer to the sleeve, the distal end of the spacer adapted to be engaged by a plunger rod of a drive mechanism to separate the spacer from the sleeve, slide the spacer within the barrel, and engage the plunger stopper with the proximal end of the spacer, the spacer further including a neck portion disposed between the proximal end and the distal end and having a reduced diameter relative to the proximal end and the distal end to define a space between the proximal end and the distal end; Including, the sleeve further includes: (a) an annular wall extending around the opening, the distal end of the spacer configured to engage an inner surface of the annular wall; and (b) a locking cap configured to secure the syringe within the sleeve, the opening of the sleeve being defined by a portion of the locking cap extending over the distal opening of the barrel such that the spacer is configured to couple to the locking cap; and a cover configured to couple to the sleeve near the distal end, the locking cap disposed proximally of the cover, the cover including an opening therethrough and a proximally extending annular wall extending around the opening, the annular wall of the cover extending around the annular wall of the locking cap. cassette.

Images