Pre-filled syringe safety devices and injectors, systems, and methods of use

Abstract

An injector including a cartridge, a casing, a tube, a plunger slider, a ring, and a biasing member. The cartridge can support the syringe at least partially therein. The casing can include a casing distal opening, an inner surface, an internal volume, a slider slot extending through the tubular body, a side opening, and a track defined on the inner surface. The tube can be slidably engaged with the cartridge and configured to be in an extended state and in a retracted state. The plunger slider can engage the plunger of the syringe within the internal volume of the casing and extend through the slider slot of the casing. The ring is supported by the tube and includes a protrusion that is positioned at least partially within the track. A portion of the ring provides visual indication through the side opening of the casing that the injector has been used.

Description

PRE-FILLED SYRINGE SAFETY DEVICES AND INJECTORS, SYSTEMS, AND METHODS OF USECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 624,997, filed January 25, 2024, and U.S. Provisional Patent Application No. 63 / 554,719, filed February 16, 2024, both of which are incorporated by reference in their entireties for all purposes.TECHNICAL FIELD

[0002] The present disclosure relates to a pre-filled syringe safety devices and injectors, systems, and methods of use. More particularly, the disclosure relates to pre-filled syringe safety devices and injectors, systems, and methods that are manually actuated to deliver a dose of a drug.BACKGROUND

[0003] Auto- injectors are medical devices that deliver a single dose of a drug via an enclosed, spring-loaded syringe. Conventionally, auto-injectors are designed to be selfadministered, but can be administered by others. Auto-injectors are relatively easy to administer as compared with a syringe and needle, which require dosing of the drug into the syringe. Auto-injectors can mitigate fears associated with seeing an exposed needle. But, some patients may also fear the abrupt stab of the needle from auto-injectors.

[0004] Despite auto-injectors and conventional syringes and needles, many patients still fear needle injections. The fear can be so great that some patients may even quit administering their medications due to problems they face with auto-injectors and other injection methods. This causes problems for physicians looking to maintain patients on injectable therapies, insurance companies covering patients requiring injectable therapies, and pharmaceutical companies looking to maintain patients on their medications.

[0005] It is with these thoughts in mind, among others, that aspects of the pre-filled syringe safety devices and injectors were conceived. By utilizing the pre-filled syringe safety devices and injectors described herein, patients will be more likely to maintain use of their medications as there will be less reasoning to stop taking their medications. Increased medication maintenance provides improved health outcomes for patients and improved experiences for all entities involved in the injection market.SUMMARY

[0006] Aspects of the present disclosure relate to an injector for use with a syringe having a plunger, a barrel, and a needle. The injector may include a cartridge configured to support the syringe at least partially therein. The injector may also include a casing including a casing distal opening, an inner surface, an internal volume, a slider slot extending through the tubular body, a side opening, and a track defined on the inner surface, the track including a starting position and a locked position, the side opening extending through the casing, the casing configured to support the cartridge and the syringe. The injector may also include a tube including a tube distal end, the tube slidably engaged with the cartridge and configured to be in an extended state and in a retracted state, wherein, in the retracted state, the needle of the syringe extends beyond the tube distal end and the casing distal opening. The injector may also include a plunger slider configured to engage the plunger of the syringe within the internal volume of the casing and extend through the slider slot of the casing, wherein movement of the plunger slider and the plunger of the syringe are fixed together. The injector may also include a ring supported by the tube and including a protrusion that is positioned at least partially within the track, the protrusion configured to be guided within the track from the starting position to the locked position, wherein, in the locked position, a portion of the ring provides visual indication through the side opening of the casing that the injector has been used. The injector may also include a biasing member engaged with the cartridge and the ring so as to bias the ring axially and rotationally, the biasing member biasing the tube in the extended state.

[0007] In certain instance, the portion of the ring in which provides visual indication through the side opening of the casing that the injector has been used may include the protrusion.

[0008] In certain instance, the protrusion of the ring may include a marking providing the visual indication, the marking including at least one of a color or an inscription.

[0009] In certain instance, the side opening may extend through the casing to a section of the track.

[0010] In certain instance, the section of the track may include the locked position of the track.

[0011] In certain instance, the portion of the ring in which provides visual indication through the side opening of the casing that the injector has been used may include the protrusion, and the protrusion of the lock ring may be obscured by the casing at the starting position on the track.

[0012] In certain instance, the track may include an in-use portion positioned between the starting position and the locked position, the in-use portion including an apex corresponding to the retracted state of the tube.

[0013] In certain instance, the starting position and the locked position may correspond to two instances of the extended state of the tube.

[0014] In certain instance, the injector may also include a distal cap configured to couple to the tube distal end of the tube, wherein the distal cap may include a tubular extension having an opening sized to receive and secure a needle cap of the syringe therein such that removal of the distal cap from the tube distal end of the tube may also remove the needle cap from the syringe.

[0015] In certain instance, the distal cap may include an upwardly extending protrusion configured to rotate the needle cap of the syringe into alignment with the opening in the tubular extension of the distal cap during insertion of the syringe into the injector.

[0016] In certain instance, the casing may include a first portion and a second portion couplable to each other.

[0017] In certain instance, the casing may further include a third portion including a top end of the injector that is couplable to the first and second portions of the casing. The third portion including at least a part of the slider slot defined therein.

[0018] In certain instance, the injector may also include the syringe having the plunger slider coupled thereto, the syringe and plunger slider being top-loadable into the injector, and the third portion of the casing being couplable to the first and second portions of the casing in order to enclose the injector.

[0019] In certain instance, the plunger slider may be configured to engage with the plunger of the syringe within the internal volume of the casing.

[0020] In certain instance, the slider slot may extend through a side wall of the casing.

[0021] In certain instance, in the retracted state, the needle may extend beyond the tube distal end about 3 to 7 millimeters.

[0022] In certain instance, in the retracted state, the needle may extend beyond the tube distal end about 10 to 15 millimeters.

[0023] In certain instance, the injector may also include the syringe.

[0024] In certain instance, the syringe may include a 1 / 2 inch needle or a 5 / 8 inch needle.

[0025] Aspects of the present disclosure relate to a method employing the injector on a subject. The method may include applying the tube to an injection site of the subject, therebycausing the tube to be in the retracted state and the needle of the syringe to enter the injection site of the subject. The method may also include distally advancing the plunger slider, thereby distally advancing the plunger of the syringe and dispensing a medicament within the syringe into the injection site of the subject, wherein movement of the plunger slider is independent of movement of the tube. The method may also include removing the tube from the injection site of the subject, thereby causing the tube to be locked in the extended state in which the needle is shielded by the tube.

[0026] Aspects of the present disclosure relate to an injector for use with a syringe having a plunger, a barrel, and a needle. The injector may include a cartridge configured to support the syringe at least partially. The injector may also include a casing including a casing distal opening, an inner surface, an outer surface, an internal volume, a slider slot extending through the casing, and a track defined on the inner surface, the casing configured to support the cartridge and the syringe, the outer surface including one or more markings indicating a volume of fluid in the syringe. The injector may also include a tube including a tube distal end, the tube slidably engaged with the cartridge and configured to be in an extended state and in a retracted state, wherein, in the retracted state, the needle of the syringe extends beyond the tube distal end and the casing distal opening. The injector may also include a plunger slider having a first portion configured to engage with the plunger of the syringe within the internal volume of the casing, the plunger slider having a second portion extending from the first portion and extending through the slider slot of the casing, the plunger slider including a third portion configured to be depressed by a user so as to cause depression of the plunger of the syringe, the plunger slider further includes a feature that identifies the one or more markings on the outer surface of the casing as the plunger slider moves through the slider slot, wherein, when the feature identifies the one or more markings on the outer surface, the volume of fluid in the syringe corresponds to the one or more markings. The injector may also include a ring supported by the tube and including a protrusion that is positioned at least partially within the track, the protrusion configured to be guided within the track. The injector may also include a biasing member engaged with the cartridge and the ring so as to bias the ring axially and rotationally, the biasing member biasing the tube in the extended state.

[0027] In certain instance, the one or more markings may include graduation lines and volumetric information.

[0028] In certain instance, the volumetric information may include measurements in milliliters.

[0029] In certain instance, the feature of the plunger slider may include a protrusion and the one or more markings are adjacent the slider slot.

[0030] In certain instance, the protrusion may include a point.

[0031] In certain instance, the one or more markings may include a first marking corresponding to a maximum volume and a second marking corresponding to a minimum volume, and wherein, in an assembled and unused state of the injector. The feature of the plunger slider may identify a third marking of the one or more markings that may be in between the first marking and the second marking.

[0032] In certain instance, the first marking may correspond to 1 .0 milliliters (ml_) and the second marking may correspond to 0.0 ml_.

[0033] In certain instance, the injector may also include a stop positioned in the slider slot proximal of the plunger slider so as to prevent proximal movement of the plunger slider within the slider slot.

[0034] In certain instance, the casing may further include a side wall, and the slider slot extends through the side wall of the casing.

[0035] In certain instance, movement of the plunger slider and the plunger of the syringe may be fixed together.

[0036] Aspects of the present disclosure relate to an injector for use with a syringe having a plunger, a barrel, and a needle. The injector may include a cartridge configured to at least partially support the syringe therein along a longitudinal axis. The injector may also include a casing supporting the cartridge and the syringe therein, the casing including a casing distal opening, an inner surface, an internal volume, a slider slot extending through the casing, and a track defined on the inner surface. The injector may also include a tube including a tube distal end, the tube slidably engaged with the cartridge and configured to be in an extended state and in a retracted state, wherein, in the retracted state, the needle of the syringe extends beyond the tube distal end and the casing distal opening. The injector may also include a plunger slider having a first portion, a second portion, and a third portion, the first portion configured to engage with the plunger of the syringe within the internal volume of the casing, the second portion extending from the first portion and extending through the slider slot of the casing, the third portion positioned outside of the casing and configured to be depressed thereby causing depression of the plunger of the syringe, wherein depression of the third portion of the plunger slider is about an axis that is offset from the longitudinal axis. The injector may also include a ring supported by the tube and including a protrusion that is positioned at least partially within the track. The injector may also include a biasing member engaged with the cartridge and the ring so as to bias the ring axially and rotationally, the biasing member biasing the tube in the extended state.

[0037] In certain instance, when the first portion of the plunger slider engages the plunger of the syringe, the first portion of the plunger slider may be encased by the casing.

[0038] Aspects of the present disclosure relate to a method of operating a syringe safety device. The method may include providing the syringe safety device including a syringe having a needle coupled to a barrel, a plunger, a casing enclosing the barrel and the plunger of the syringe and including a distal opening, a slider slot extending through the casing, a track defined on an inner surface of the casing, and a side opening. The syringe safety device may also include a tube retractable at least partially within the distal opening of the casing to expose needle of the syringe. The syringe safety device may also include a ring engaged with the tube and the track in order to permit retraction of the tube, extension of the tube, and then locking of the tube in an extended-locked state. The syringe safety device may also include a plunger slider coupled to the plunger of the syringe and extending through the slider slot. The method may also include retracting the tube. The method may also include, independently of retracting the tube, depressing the plunger slider so as to depress the plunger into the barrel of the syringe and dispense a fluid from the syringe. The method may also include extending the tube. The method may also include locking the tube in the extended-locked state. The method may also include providing a visual indication of the extended-locked state through the side opening in the casing.

[0039] In certain instance, depressing the plunger slider may come from a force outside of the casing.

[0040] In certain instance, the plunger slider may be depressed along an axis that is offset from a longitudinal axis of the syringe enclosed within the casing.

[0041] In certain instance, the ring may include a protrusion that is visible through the side opening in the casing when the tube is in the extended-locked state.

[0042] Aspects of the present disclosure relate to a method of assembling a safety syringe device. The method may include providing a syringe including a needle coupled to a barrel, a plunger engaged with the barrel, and a fluid in the barrel. The method may also include providing a casing of a safety syringe device, the casing including a first side portion, a second side portion, and a third top portion. The method may also include providing a cartridge for supporting the syringe within the casing, a tube for shielding the needle, a biasing member, and a ring. The method may also include forming a first subassembly by slidably engaging the tube and the cartridge together with the biasing member and the lock ring positioned there between. The method may also include coupling the first portion of the casing, the second side portion of the casing, and the first subassembly together, wherein a longitudinal slot is formed in one or both of the first and second side portions of the casing, the casing definingan inner volume. The method may also include forming a second subassembly by attaching the plunger slider to a plunger top of the plunger of the syringe. The method may also include forming a third subassembly by top-loading the second subassembly into the inner volume of the casing such that the plunger slider is positioned within the longitudinal slot. The method may also include attaching the third top portion of the casing to the third subassembly.

[0043] In certain instance, attaching the third top portion of the casing to the third subassembly may distally move the syringe into a final position.

[0044] In certain instance, the third top portion may include a sleeve that is slidably received within the first and second portions of the casing when the third top portion is attached to the third subassembly.

[0045] In certain instance, the method may further include coupling a distal cap to at least one of the tube or the casing.

[0046] In certain instance, attaching the third top portion of the casing to the third subassembly may cause a sterile cap covering the syringe to be received in an opening of the distal cap.

[0047] In certain instance, the distal cap may include a feature that rotates the sterile cap into alignment with the opening of the distal cap.

[0048] In certain instance, the distal cap may be threadably coupled to the casing.

[0049] In certain instance, the method may further include blocking the longitudinal slot in a position proximal of the plunger slider.

[0050] Aspects of the present disclosure relate to an injector for use with a syringe having a plunger, a barrel, and a needle. The injector may include a cartridge configured to support the syringe at least partially therein. The injector may also include a casing including a lower casing and an upper casing, the lower casing including a casing distal opening, an inner surface, an internal volume, and a track defined on the inner surface, the track including a starting position and a locked position, the casing configured to support the cartridge and the syringe, the upper casing including a top surface and a side wall extending downward from top surface, the upper casing configured to slide over at least a portion of the lower casing. The injector may also include a tube including a tube distal end, the tube slidably engaged with the cartridge and configured to be in an extended position and in a retracted position, wherein, in the retracted position, the needle of the syringe extends beyond the tube distal end and the casing distal opening. The injector may also include a first lock ring positioned between the upper casing and the lower casing, the first lock ring configured to transition from a first position and a second position, the first position preventing the upper casing from slidingrelative to the lower casing, the second position permitting the upper casing to slide relative to the lower casing. The injector may also include a second lock ring supported by the tube and including a protrusion that is positioned at least partially within the track, the protrusion configured to be guided within the track from the starting position to the locked position, wherein, movement of the second lock ring causes the first lock ring to transition from the first position to the second position. The injector may also include a biasing member engaged with the cartridge and the second lock ring so as to bias the second lock ring axially and rotationally, the biasing member biasing the tube in the extended position.

[0051] In certain instance, the casing may further include a side opening extending through the casing to the locked position of the track, wherein, in the locked position, the protrusion may provide visual indication through the side opening of the casing that the injector has been used.

[0052] In certain instance, the first lock ring may transition from the first position to the second position via rotation.

[0053] In certain instance, the first lock ring may include a body including one or more tines extending outwardly therefrom, the upper casing including a first channel and a second channel, the one or more tines positioned within the first channel when the first lock ring is in the first position, the one or more tines positioned within the second channel when the first lock ring is in the second position.

[0054] In certain instance, the first channel may be a horizontal channel extending around at least a portion of a circumference of an inner surface of the upper casing, the second channel may be a vertical channel extending linearly along an inner surface of the upper casing.

[0055] In certain instance, the first channel and the second channel may intersect each other.

[0056] In certain instance, the injector may further include a member coupled to the second lock ring and configured to contact the first lock ring and cause the first lock ring to transition from the first position to the second position.

[0057] Aspects of the present disclosure relate to a method. The method may include providing the injector. The method may also include retracting the tube so as to expose the needle of the syringe beyond the tube distal end and the casing distal opening, wherein retracting the tube may cause movement of the second lock ring. The method may also include transitioning of the first lock ring from the first position to the second position. The method mayalso include depressing the upper casing relative to the lower casing thereby dispensing a fluid in the syringe.

[0058] In certain instance, the method may also include extending the tube over the needle of the syringe. The method may further include locking the tube in the extended position.BRIEF DESCRIPTION OF THE DRAWINGS

[0059] The foregoing and other objects, features, and advantages of the present disclosure set forth herein will be apparent from the following description of particular embodiments of those inventive concepts, as illustrated in the accompanying drawings. It should be noted that the drawings are not necessarily to scale; however the emphasis instead is being placed on illustrating the principles of the inventive concepts. Also, in the drawings the like reference characters may refer to the same parts or similar throughout the different views. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than limiting.

[0060] FIG. 1 A is an isometric view of a pre-filled syringe safety device and injector (referred to as “an injector” hereinafter) in an assembled state.

[0061] FIGS. 1 B-1 E are, respectively, side views of the injector in an assembled state in four different rotational orientations.

[0062] FIGS. 1 F and 1 G are, respectively, top and bottom views of the injector in an assembled state.

[0063] FIGS. 2A and 2B are, respectively, an isometric exploded view and a side view of the injector.

[0064] FIG. 3A is an isometric view of an inner side of a first casing.

[0065] FIGS. 3B and 3C are, respectively, front view of the first casing showing the inner side thereof and a back view of the first casing showing the outer side thereof.

[0066] FIGS. 3D and 3E are, respectively, side views of the first casing from opposite sides.

[0067] FIGS. 3F and 3G are, respectively, top and bottom views of the first casing.

[0068] FIG. 4A is an isometric view of an inner side of a second casing.

[0069] FIG. 4B and 4C are, respectively, front view of the second casing showing the inner side thereof and a back view of the second casing showing the outer side thereof.

[0070] FIGS. 4D and 4E are, respectively, side views of the second casing from opposite sides.

[0071] FIGS. 4F and 4G are, respectively, top and bottom views of the second casing.

[0072] FIG. 5A is an isometric view of a cartridge for supporting a syringe within the injector.

[0073] FIGS. 5B and 5C are, respectively, side views of the cartridge from two different rotational orientations.

[0074] FIGS. 5D and 5E are, respectively, top and bottom views of the cartridge.

[0075] FIGS. 6A and 6B are, respectively, an isometric view and a side view of a distal tube of the injector.

[0076] FIGS. 6C and 6D are, respectively, top and bottom views of the distal tube.

[0077] FIGS. 7A-7E are, respectively, an isometric view, two side views, a top view, and a bottom view of a plunger slider.

[0078] FIGS. 8A-8C are, respectively, an isometric view, a bottom view, and a side view of a lock ring.

[0079] FIG. 9 is an isometric view of a distal cap of the injector.

[0080] FIG. 10 is an isometric view of a compression spring of the injector.

[0081] FIG. 11A is a side view of the injector with the injector cap and syringe cap coupled thereto removed from the distal tube.

[0082] FIG. 11 B is a side view of the injector of FIG. 11 A with the distal tube retracted.

[0083] FIG. 11C is a side view of the injector of FIG. 11 B with the plunger slider rotated so it is distally depressible.

[0084] FIG. 11 D is a side view of the injector of FIG. 11C with the plunger slider depressed distally.

[0085] FIG. 11E is a side view of the injector of FIG. 11 D with the injector cap and syringe cap coupled back to the distal tube and syringe, respectively.

[0086] FIG. 12A is a cross-sectional side view of the injector prior to use and with the plunger slider rotated in order to view the internal components of the injector.

[0087] FIG. 12B is a cross-sectional side view of the injector of FIG. 12A with the injector cap and syringe cap (coupled thereto) removed from the distal tube.

[0088] FIG. 12C is a cross-sectional side view of the injector of FIG. 12B with the distal tube retracted from, for example, application of the distal tube to a patient’s skin.

[0089] FIG. 12D is a cross-sectional side view of the injector of FIG. 12C with the plunger slider depressed distally so as to dispense the drug from the syringe.

[0090] FIG. 12E is a cross-sectional side view of the injector of FIG. 12D with the distal tube advanced from, for example, the distal tube being removed from the patient’s skin.

[0091] FIG. 12F is a cross-sectional side view of the injector of FIG. 12E with the injector cap and syringe cap returned to the distal tube.

[0092] FIG. 13A is a side view of the injector with the first casings rotated away from the rest of the injector so as to expose the internal components thereof.

[0093] FIG. 13B is a close up and vertically flipped view of the track defined in the first casing with an image of the post of the lock ring positioned within the track. The post of the lock ring is positioned at the start of the track.

[0094] FIG. 13C is a side view of the injector with the first casings rotated away from the rest of the injector so as to expose the internal components thereof.

[0095] FIG. 13D is a close up and vertically flipped view of the track defined in the first casing with an image of the post of the lock ring positioned within the track. The post of the lock ring is positioned at about a midpoint between the start and locking end of the track.

[0096] FIG. 14A is a front view of another embodiment of an injector in an assembled state.

[0097] FIG. 14B is a close-up view of the graduation lines on the casing of the injector and the indicator on the plunger slider pointing to a graduation line that corresponds to a volume in the syringe.

[0098] FIG. 14C is a bottom-up isometric and exploded view of the injector.

[0099] FIG. 14D is a top-down isometric and exploded view of the injector.

[0100] FIG. 14E is a front and exploded view of the injector.

[0101] FIG. 14F is a side and exploded view of the injector.

[0102] FIGS. 15A-15C are, respectively, isometric interior view, side interior view, and side outer view of a first casing.

[0103] FIGS. 16A-16C are, respectively, isometric interior view, side interior view, and side outer view of a second casing.

[0104] FIGS. 17A and 17B are, respectively, bottom-up isometric and top-down isometric views of a third casing or casing cap.

[0105] FIGS. 18A and 18B are, respectively, top-down isometric and bottom-up isometric views of a plunger slider.

[0106] FIGS. 18C and 18D are, respectively, top-down isometric views of the injector cap from two different rotational orientations.

[0107] FIGS. 18E and 18F are, respectively, top-down isometric and bottom-up isometric views of a lock ring.

[0108] FIGS. 18G and 18H are, respectively, top-down isometric and bottom-up isometric views of a tube.

[0109] FIGS. 181 and 18J are, respectively, top-down isometric and bottom-up isometric views of a cartridge.

[0110] FIG. 19A is a side view of the injector with the first casing removed or opened up so as to view the internal components of the injector, prior to use.

[0111] FIG. 19B is a side view of the injector with the first casing removed or opened up so as to view the internal components of the injector, with the syringe cap removed so as to expose the tube.

[0112] FIG. 19C is a side view of the injector with the first casing removed or opened up so as to view the internal components of the injector, with the tube in a retracted state and the needle exposed.

[0113] FIG. 19D is a side view of the injector with the first casing removed or opened up so as to view the internal components of the injector, with the plunger slider moved distally in order to depress the plunger of the syringe and eject the medication.

[0114] FIG. 19E is a side view of the injector with the first casing removed or opened up so as to view the internal components of the injector, with the tube having been moved back into the extended state in which the needle is shielded.

[0115] FIG. 20 is a close up side view of the distal end of the injector with the casing shown in phantom where the protrusion of the lock ring is shown through the side opening in the casing.

[0116] FIGS. 21A-21 B are, respectively, a pair of isometric top-down views of another embodiment of an injector in two different rotational orientations.

[0117] FIGS. 21 C and 21 D are, respectively, a side view and a cross-sectional side view of the injector.

[0118] FIGS. 22A-22C are, respectively, an isometric top-down and exploded view of two- halves of a plunger cap, a side view of a first side of the plunger cap, and a side view of a second side of the plunger cap.

[0119] FIGS. 23A-23B are isometric top-down and isometric bottom-up views of the first casing of the injector.

[0120] FIGS. 24A and 24B are, respectively, isometric top-down and isometric bottom-up views of the second casing of the injector.

[0121] FIGS. 25A-25C are, respectively, a top-down isometric view, a bottom-up isometric view, and a side view of a plunger cap lock ring.

[0122] FIGS. 26A and 26B are, respectively, a top-down isometric view, and a bottom-up isometric view of a cartridge of the injector.

[0123] FIGS. 27A and 27B are, respectively, a top-down isometric view, and a bottom-up isometric view of a tube lock ring of the injector.

[0124] FIG. 28A is a side view of the injector with one half of the casing and one half of the plunger cap removed to show the internal components of the injector, prior to use.

[0125] FIG. 28B is a side view of the injector with one half of the casing and one half of the plunger cap removed to show the internal components of the injector, with the syringe cap removed so as to expose the tube.

[0126] FIG. 28C is a side view of the injector with one half of the casing and one half of the plunger cap removed to show the internal components of the injector, with the tube in a retracted state and the needle exposed.

[0127] FIG. 28D is a side view of the injector with one half of the casing and one half of the plunger cap removed to show the internal components of the injector, with the plunger cap moved distally in order to depress the plunger of the syringe and eject the medication.

[0128] FIG. 28E is a side view of the injector with one half of the casing and one half of the plunger cap removed to show the internal components of the injector, with the tube having been moved back into the extended state in which the needle is shielded.

[0129] FIG. 29A is a flowchart of exemplary assembly steps of the injector of FIGS. 14- 20.

[0130] FIG. 29B is a flowchart of exemplary assembly steps of the injector of FIGS. 21- 28.DETAILED DESCRIPTION

[0131] U.S. Patent Application No. 18 / 285,671 , filed by October 5, 2023, is incorporated by reference in its entirety for all purposes.

[0132] FIG. 1 A is an isometric view of a pre-filled syringe safety device and injector 100 (referred to as “an injector” or “the device” hereinafter) in an assembled state. The injector 100, as referred to herein, may include a pre-filled syringe that includes a dose of a substance (e.g., drug). Alternatively, the injector 100 may be without a pre-filled syringe. The injector 100 may be one component of an injector system that includes a pre-filled syringe. The injector 100 may be one component of a kit that includes the pre-filled syringe, packaging, and instructions for use.

[0133] The injector 100 as described herein allows for a pre-filled syringe to be loaded into the device for injection of a dose of a substance. The injector described and shown herein permits a user to inject the needle into an injection site at his or her own pace, and then manually inject the medication. This is different than conventional auto-injectors, which inject and dispense medication in a single step. With the injector 100 described herein, the needle may be shielded by a portion the device before and after use. And after use, the needle may be locked from further exposure outside of the device. Thus, injection of the substance is performed manually by the user after the needle is exposed (and injected) into an injection site. The device may also inhibits dispensing of the substance from the pre-filled syringe until the needle is exposed.

[0134] The pre-filled syringe includes a barrel holding a substance (e.g., drug), a plunger slidingly engaged with the barrel, and a needle coupled to the barrel opposite the plunger. The barrel may also include a flange or projection at a proximal end thereof.

[0135] Referring to FIG. 1 A, the injector 100 includes a proximal end 102, a distal end 104 opposite the proximal end 102, and a longitudinal axis 106 extending longitudinally through the proximal and distal ends 102, 104. The injector 100 includes a casing 108, which includes first and second casings 110, 1 12, respectively, that are designed to be affixed to each other via snaps, clips, or the like. The casing 108 of the injector 100 is not limited to a two-part casing. In certain instances, the casing 108 may be a single piece. In certain instances, the casing 108 may be more than two pieces. Still referring to FIG. 1A, the injector 100 further includes a tube 114 at the distal end 104. The tube 1 14 is moveable relative to the casing 108. More particularly, the tube 1 14 is biased in the extended position shown in FIG. 1A and is retractable relative to the casing 108 upon the application of a force to the tube 114 that overcomes the biasing.

[0136] The injector 100 further includes a cap 1 16 that is coupled to the tube 1 12. The cap 116 may be sized to also couple to a needle cap of the syringe (not shown) that coversthe needle. Conventionally, pre-filled syringes are manufactured with a needle cap in place to guard the needle. In this way, the injector 100 can be assembled into an injector system in a sterile environment with the needle cap in place and with the cap 1 16 sized to couple to the needle cap. Then, upon removal of the cap 1 16 from the tube 114, the cap 116 also removes the needle cap.

[0137] The injector 100 further includes a plunger slider 118 near the proximal end 102 thereof. The plunger slider 118 is engaged with the plunger of the syringe, which is housed or enclosed within the injector 100. As will be described in this application in reference to subsequent figures, the plunger slider 1 18 is rotatable transversely to the longitudinal axis 106 and, then, it is distally depressible so as to dispense the substances within the syringe.

[0138] FIGS. 1 B-1 E are, respectively, side views of the injector 100 in an assembled state in four different rotational orientations. As seen in the figures, a window 120 is defined in each of the casings 1 10, 1 12. The window 120 is a passageway through the casings 110, 1 12 so the syringe and / or the substance within the barrel of the syringe is visible. Thus, a user can visually see if the injector 100 is loaded with a pre-filled syringe.

[0139] FIGS. 1 F and 1G are, respectively, top and bottom views of the injector 100 in the assembled state. The casing 108 defines a generally circular perimeter with the plunger slider 1 18 jutting out from the perimeter. In this way, a user can easily and conveniently rotate and depress the plunger slider 1 18 with a thumb while the rest of the hand grasps around the casing 108.

[0140] FIGS. 2A and 2B are, respectively, an isometric exploded view and a side view of the injector 100. In addition to the components already described and labeled on the figures, the injector 100 further includes cartridge 122 for receiving and securing the syringe within the casing 108, a biasing member 124 (e.g., a spring) in which biases the tube 1 14 in an extended position relative to the casing 108 and the cartridge 122, and a lock ring 126 that interfaces or engages with the biasing member 124 and with the tube 1 14.

[0141] FIG. 3A is an isometric view of an inner side of a first casing 1 10, which couples with the second casing 112 (not shown) to form the full casing 108 (not shown). FIGS. 3B and 3C are, respectively, front view of the first casing 1 10 showing the inner side thereof and a back view of the first casing 110 showing the outer side thereof. FIGS. 3D and 3E are, respectively, side views of the first casing 1 10 from opposite sides. FIGS. 3F and 3G are, respectively, top and bottom views of the first casing 1 10.

[0142] As best seen in FIGS. 3A and 3B, at the proximal end (top of image), the first casing 1 10 includes a slider slot or opening 140 formed by a transverse section 128 (also referred to as a horizontal section) that extends generally perpendicular to the longitudinal axis 130 of thefirst casing 1 10. The transverse section 128 is contiguous with a longitudinal section 132 (also referred to as a vertical section) that is jointly defined by both the first casing 110 and the second casing. The transverse section 128 and the longitudinal section 132 are both through- holes defined through the casing 110, which permits a stem of the plunger slider 118 (not shown) to extend therethrough. More particularly, the transverse section 128 of the slider slot 140 permits transverse or horizontal rotation of the plunger slider 118, and then the longitudinal section 132 permits distal advancement or depression of the plunger slider 118, which causes dispensing of the substances from the syringe.

[0143] Also at the proximal end of the first casing 1 10 is a plunger guide recess 134 defined on an inner surface 142 of the first casing 1 10. The recess 134 does not extend through the entirety of the first casing 110. However, in alternative embodiments, the recess 134 may extend through an entirety of the first casing 1 10. The recess 134 includes a transverse section 136 (also referred to as a horizontal section) that is also partially defined on the second casing 112 (as shown in FIGS. 4A and 4B, among others). The transverse section 136 of the recess 134 is contiguous with a longitudinal section 138 (also referred to as a vertical section) extending along the longitudinal axis 130 of the first casing 110. The recess 134 is sized to receive and guide a protrusion on the plunger slider 1 18 (not shown in FIGS. 3A-3F). The plunger slider 118 is designed such that the protrusion and the stem of the plunger slider 118 are both guided by the slider slot 140 and recess 134 simultaneously to stabilize the plunger slider 1 18 during operation.

[0144] As seen in FIGS. 3A and 3B, a midsection of the first casing 1 10 includes projections 144 surrounding the window 120 and extending longitudinally along the midsection. The projections 144 include proximally-facing shoulders 146 sized and shaped to abut a portion of the syringe (not shown) therein. As seen in the figures, the first casing 1 10 includes recesses to facilitate coupling with the tabs on the second casing 1 12.

[0145] At the distal end, the first casing 110 includes a track or guide 148 defined within the inner surface 142. The track 148 is a recess defined within the inner surface 142 that is sized and shaped to receive and guide the protrusion on the lock ring 126 during retraction and extension of the tube 1 14 relative to the cartridge 122 and the first casing 1 10. The track 148 includes a starting point 158 and a terminus 160. The track 148 further includes a first longitudinal section 150 that is contiguous with a transverse section 152. The transverse section 152 is contiguous with a second longitudinal section 154 that includes an arched path. The second longitudinal section 154 is contiguous with a transverse locking section 156.

[0146] The biasing member 124 (not shown in FIGS. 3A and 3B), which is depicted as a spring, provides at least two functions. One, it biases the tube 1 14 in an extended position soas to shield the needle of the syringe. That is, the biasing member 124 exerts a longitudinal force distally on the tube 1 14. Second, the biasing member 124 rotationally biases the lock ring 126 so as to exert a rotational force from right-to-left in FIG. 3A. That is, the biasing member 124 is biased to advance in the transverse directions of the track 148. For instances, the rotationally biasing of the biasing member 124 causes the lock ring 126 to transition through the transverse section 152 and the transverse locking section 156 without additional force provided by the user. To overcome the longitudinal force of the biasing member 124, the user applies a proximal force on the tube 1 14. This causes the protrusion of the lock ring 126 to travel along the first longitudinal section 150. Once, the protrusion is at the terminus of the first longitudinal section 150, the lock ring 126 automatically rotates through the transverse section 152 via the rotationally biasing force of the biasing member 124. Then, as the user relieves proximal-directed force on the tube 1 14, the tube 1 14 extends, which causes the biasing member 124 to extend. This causes the protrusion of the lock ring 126 to travel along the second longitudinal section 154 to its terminus. At its terminus, the lock ring 126 automatically rotates into and through the transverse locking section 156 to its terminus. At the terminus 160 of the track 148, the biasing member 124 rotationally biases the protrusion of the lock ring 126 into an end wall. Longitudinal movement of the lock ring 126 is restricted as well given the end wall is only slightly larger than the protrusion of the lock ring 126. Thus, once the protrusion of the lock ring 126 has travelled from start 158 to the terminus 160, the lock ring 126 is locked at the terminus 126 of the track 148. Since the lock ring 126 is coupled to the tube 114, this mean that when the lock ring 126 is locked at the terminus 126 of the track, the tube 1 14 is locked in the extended position and is restrained from transitioning back to the retracted position. At the distal end, the first casing 1 10 includes a distal opening 162 that is formed by the mating of the first and second casings 110, 1 12.

[0147] FIG. 4A is an isometric view of an inner side of a second casing 1 12. FIG. 4B and 4C are, respectively, front view of the second casing 1 12 showing the inner side thereof and a back view of the second casing 1 12 showing the outer side thereof. FIGS. 4D and 4E are, respectively, side views of the second casing 1 12 from opposite sides. FIGS. 4F and 4G are, respectively, top and bottom views of the second casing 1 12.

[0148] As best seen in FIGS. 4A and 4B, at the proximal end of the second casing 1 12 (top of image), the longitudinal section 132 of the slider slot 140 is partly formed on the second casing 1 12. As described with reference to FIGS. 3A-3G, the slider slot 140 is formed by a transverse section 128 that extends generally perpendicular to the longitudinal axis 130 of the first casing 110. The transverse section 128 is contiguous with the longitudinal section 132 that is jointly defined by both the first casing 1 10 and the second casing 1 12. Similarly, a portion of the transverse section 136 of the plunger guide recess 134 is defined on an innersurface 164 of the second casing 112, whereas another portion of it is defined on the inner surface 142 of the first casing 1 10. The recess 134 does not extend through the entirety of the second casing 1 12. However, in alternative embodiments, the recess 134 may extend through an entirety of the second casing 1 12. The recess 134 includes the transverse section 136 that is also partially defined on each of the first and second casings 1 10, 1 12. The transverse section 136 of the recess 134 is contiguous with a longitudinal section 138 extending along the longitudinal axis 130 of the first casing 1 10. The recess 134 is sized to receive and guide a protrusion on the plunger slider 1 18 (not shown in FIGS. 4A-4G).

[0149] At the proximal end of the second casing 1 12 is a plunger guide slot or opening 166 extending through the second casing 1 12. The plunger guide slot 166 includes a transverse section 168 extending generally perpendicular to the longitudinal axis 130 (also described as extending horizontally) of the second casing 1 12. The transverse section 168 is contiguous with a longitudinal section 170 that extends longitudinally along the second casing 1 12 (also described as extending vertically). The plunger guide slot 166 is sized and shaped to received and guide a protrusion on the plunger slider 118. Unlike the plunger guide recess 134, the plunger guide slot 166 extends through the entire sidewall of the second casing 112. This provides a robust guiding alignment of the plunger slider 1 18 as well as a visual indication or verification of the location of the plunger slider 1 18 relative to the casing 108.

[0150] At a midsection of the second casing 112 are the protrusions 144 extending inwardly towards a center of the casing 108. The protrusions 144 support and centrally position the cartridge as will be explained subsequently. The second casing 1 12 also includes recesses 172 defined within the protrusions 144 for receiving and securing the flange of the barrel of a syringe, which is in turn supported in the cartridge 122. With the syringe barrel held in place by the recesses 172 (and generally held in a fixe position relative to the casing 108), the plunger slider 1 18 operates to distally depress the plunger of the syringe into the barrel and, thus, dispense the substance (e.g., drug) from the barrel of the syringe.

[0151] On a distal side of the protrusions 144 are distally-facing shoulders 174 that are oppositely positioned from the proximally-facing shoulders 146. The distally-facing shoulders 174 are sized and shaped to about a portion of the cartridge 122 and to restrict proximal movement of the cartridge 122 within the casing 108.

[0152] Referring back to the proximal end, the second casing 112 includes a proximal cap 178 that encapsulates the proximal end of the casing 108 when the first and second casings 1 10, 1 12 are coupled together. At the midsection and at the distal end, the second casing 1 12 includes tabs 176 that jut outwards and are sized and shaped to couple with corresponding recesses on the first casing 1 10.

[0153] FIG. 5A is an isometric view of the cartridge 122 for supporting a syringe within the casing 108 (not shown) of the injector 100 (not shown). FIGS. 5B and 5C are, respectively, side views of the cartridge 122 from two different rotational orientations. FIGS. 5D and 5E are, respectively, top and bottom views of the cartridge 122. As seen in the figures, the cartridge 122 is a tubular body having a passageway 180 extending from a proximal opening 182 at the proximal end (top of image in FIG. 5A) to a distal opening 184 at the distal end (bottom of image in FIG. 5A). The cartridge 122 includes a pair of alignment fins 186 extending outward from the outer surface 188 of the cartridge 122. The alignment fins 186 include distal surfaces 190 for abutting against a proximally-facing surface of the casing 108 to inhibit distal advancement. In certain instances, the alignment fins 186 may be a single fin or more than a pair of fins. When inserted into the casing 108, the alignment fits 186 are sized and shaped to be received within the protrusions 144 on the first casing 1 10. And, the distal surfaces 190 abut an upper wall 192 (as seen in FIG. 3A) of the protrusions 144 that define a part of the casing for the window 120.

[0154] At a midsection of the cartridge 122 is an annular flange 192 in the shape of a frustoconical ring with a proximally-facing surface 194 that is generally perpendicular to a longitudinal axis of the cartridge 122. The proximally-facing surface 194 is joined by a distal- facing surface 196 that is angled or beveled so as to angle proximally. When the cartridge 122 is positioned within the casing 108, the annular flange 192 abuts against the distally-facing shoulders 174 of the protrusions 144. This abutment prevents proximal movement of the cartridge 122 within the casing 108. As such, once inserted into the casing 108, the cartridge is prevented from both proximal and distal movement therein via interaction of the annular flange 192 with the distally- facing shoulders 174 of the protrusions 144 (proximal movement) and interaction of the alignment fins 186 with the upper wall 192 of the protrusions that define part of the casing of the window 120.

[0155] As seen in FIGS. 5D and 5E, the annular flange 192 includes a through-hole 198 extending from the distal surface 196 to the proximal surface 194. The through-hole 198 is sized to receive an end of the biasing member 124 (e.g., spring)(not shown in FIGS. 5D and 5E). As described previously, the biasing member 124 exerts both a longitudinal force on the lock ring 126 and tube 114 in an outward or extended position, and a rotational force on the lock ring 126. The biasing member 124 is coupled to the cartridge 122 via the through-hole 198, and the cartridge 122 is fixed in its position within the casing 108 as described previously.

[0156] FIGS. 6A and 6B are, respectively, an isometric view and a side view of the tube 1 14 of the injector 100. FIGS. 6C and 6D are, respectively, top and bottom views of the tube 1 14. As seen in the figures, the tube 114 includes a passageway 200 extending from a proximal opening 202 to a distal opening 204. The tube 114 includes a tubular surface 206and coupling structure 208 at the proximal end. The coupling structure 208 includes an annular rim 210 and a proximal projection 212. The coupling structure 208 is sized to receive the lock ring 126 thereon. That is, the lock ring 126 may be fitted over the proximal projection 212 in a friction fit arrangement or they may be affixed together (e.g., mechanical or chemical fastener). The distal end of the tube includes nubs 214 protruding distally from the distal rim of the tube 1 14. The nubs 214 abut the skin of the user when the injector 100 is applied to the patient. The nubs 214 function sensory stimulation to the user so the fear of needlestick is reduced.

[0157] FIGS. 7A-7E are, respectively, an isometric view, two side views, a top view, and a bottom view of a plunger slider 1 18. As seen in the figures, the plunger slider 1 18 includes a cap 216 having a top surface 218, and a cylindrical sidewall 220 coupled to the top surface 218. A cavity 222, as seen in FIG. 7E, is defined between the sidewall 220 and the top surface 218 for receiving the end of the plunger of the syringe therein. Continuing with FIG. 7E, a series of inwardly extending projections 228 extend from an inner surface 224 of the sidewall 220 to the underside 226 of the cap 216. The series of projections 228 centrally position the plunger of the syringe so it does not move off-center.

[0158] Coupled to and extending outward from the sidewall 220 of the cap 216 are first and second projections 230, 232. The first projection 230 is in the form of a four-sided projection that is sized and shaped to fit and slide within the recess 134 defined partially on the first and second casings 110, 1 12. The second projection 232 is in the form of a post that is sized and shaped to fit and slide within the plunger guide slot 166 defined within the second casing 1 12.

[0159] As best seen in FIGS. 7D and 7E, the plunger slider 118 includes an engagement structure 236 (thumb slider) coupled to the cap 216 via a stem 234. The engagement structure 236 includes ridges for grip and a radially projecting portion for grip as well. The engagement structure 236 may include alternative shapes and sizes. The embodiment shown in the drawings is merely exemplary of an engagement structure 236. The cap 216 is sized and shaped to fit within the casing 108 such that: the stem 234 extends through the plunger slider slot 140 defined within the casing 108; the first projection extends into the plunger slider recess 134 of the casing 108; and the second projection extends into the plunger guide slot 166 of the casing 108. In this way, the plunger slider 1 18 is guided by three guides as a user rotates the plunger slider 118 and then applies distal pressure on the engagement structure 236. The three guides ensure correct alignment of the plunger slider 118 and consistent application of the injector 100 generally.

[0160] FIGS. 8A-8C are, respectively, an isometric view, a bottom view, and a side view of the lock ring 126. The lock ring 126 includes a cylindrical sidewall 238 with a through-hole240 extending from a proximal end (top of lock ring 126 in FIGS. 8A and 8C) to the distal end. Extending outward from the sidewall 238 in a direction perpendicular to a longitudinal axis of the lock ring 126 is a protrusion or post 242 of cylindrical shape. The protrusion 242 is sized and shaped to be received within and be guided by the track 148 on the inner surface 142 of the first casing 1 10 as described previously. At the proximal end of the lock ring 126 is an incut section 244 with a bore hole 246 defined therein for receiving an end of the biasing member or spring 124. It is noted that the lock ring 126 may be integrally formed with the distal tube 1 14. That is, the lock ring 126 and the distal tube 1 14 may be a single piece construction.

[0161] FIG. 9 is an isometric view of a distal cap 1 16 of the injector 100. The cap 1 16 includes tube 248 having an outer cylindrical surface 250 sized to fit within the tube 114 and be retained therein. At the base of the tube 248 is a flange 252 with series of divots 254 for receiving the nubs formed on the distal end of the tube 114 when the tube 114 is mated with the cap 116. Extending distally from the flange 252 is a dual-sided structure with ridges 256 for grasping by the user. The internal sides of the tube 248 include surfaces to closely abut and couple to a conventional syringe cap. Thus, removal of the cap 1 16 from coupling with the tube 1 14 also removes the syringe cap from the syringe.

[0162] FIG. 10 is an isometric view of the biasing member 124 of the injector 100. As seen in the figure, the biasing member 124 is a spring, and, more particular, a compression spring. The biasing member 124 includes a pair of ends 258. One of the pair of ends 258 is to be received within the through-hole 198 of the annular flange 192 of the cartridge 122, and the opposite end 258 of the biasing member 124 is received within the through-hole 246 of the lock ring 126. As described previously, during use, the biasing member 124 exerts a biasing force on the lock ring 126, which is fitted to the proximal end of the tube 1 14. The biasing force causes the tube 1 14 to be biased in an extended position covering the needle of the syringe. The biasing member 124 is also assembled with a rotational bias such that the lock ring 126 is rotationally forced to travel through the track 148 defined on the first casing 1 10. The rotational biasing of the lock ring 126 causes the locking of the lock ring 126 and coupled tube 1 14 upon a single retraction and subsequent extension of the tube 114 relative to the casing 108. Stated differently, the injector 100 is designed to permit a single retraction of the tube 1 14 to expose the needle of the syringe. And, upon re-extension of the tube 1 14 following retraction, the rotational bias of the biasing member 124 causes locking of the tube 1 14 in an extended position shielding the needle.

[0163] FIG. HA through 11 E depict the injector 100 in various stages of use. FIG. 11A is a side view of the injector 100 with the injector cap 1 16 and syringe cap 260 coupled thereto removed from the distal tube 1 14. In this view, the needle is shielded by the tube 114 of the injector 100, but the injector 100 is ready to be applied to the user.

[0164] FIG. 1 1 B is a side view of the injector 100 of FIG. 1 1A with the distal tube 1 14 retracted. In this view, the user has applied the distal tube 1 14 to a portion of the body for injection. The applied force on the distal tube 114 is in the proximal direction (towards top of image) and is sufficient to overcome the biasing force of the biasing member 124 (not shown). Thus, as the distal tube 114 retracts into the casing 108, the needle 262 is exposed. It is noted that the needle 262 remains in a fixed position relative to the casing 108. That is, the needle 262 is exposed via retraction of the distal tube 1 14. And, the needle 262 is subsequently shielded by extension of the distal tube 1 14 over the needle 262. Referring back to FIG. 11 B, in this view, the needle 262 would be inserted into the patient’s skin.

[0165] FIG. 11 C is a side view of the injector 100 of FIG. 11 B with the plunger slider 1 18 rotated so it is distally depressible. With the needle 262 inserted into the skin, the user then rotates the plunger slider 1 18 transversely within the slider slot 140 so the stem (not shown) of the plunger slider is aligned with the longitudinal section 132 of the slider slot 140.

[0166] FIG. 11 D is a side view of the injector 100 of FIG. 11 C with the plunger slider 1 18 depressed distally. Once the plunger slider 1 18 is aligned with the longitudinal section 132 of the slider slot 140, the plunger slider 1 18 is capable of being distally advanced so as to dispense the substance from the syringe. In this view, the user has dispensed the substance into the tissue.

[0167] FIG. 11 E is a side view of the injector 100 of FIG. 1 1 D with the injector cap 116 and syringe cap 260 coupled back to the distal tube 1 14 and syringe, respectively. After the plunger slider 1 18 is distally advanced, the user may proximally retract the injector 100 from the injection site. This causes the distal tube 1 14 to distally extend into the locked position. At this point, the syringe cap 260 and injector cap 1 16 may be reinserted in the distal tube 114. The image shows the syringe cap 260 being reinserted, but it may be sufficient to simply reinsert the injector cap 1 16.

[0168] FIGS. 12A through 12F depict various images of the injector 100 in cross-section so the interaction of the various components is visible. These images depict the syringe 270 including the barrel 264 having a flange 266, the plunger 268, and the needle 262. FIG. 12A is a cross-sectional side view of the injector 100 prior to use and with the plunger slider 1 18 rotated so it is aligned with the longitudinal section 132 of the plunger slider slot 140 in order to view the internal components of the injector 100. As seen in the figure, the proximal end of the plunger 268 is positioned within the cavity 222 of the plunger slider 118. And, the flange 266 of the barrel 264 is positioned within the recesses 172 defined within the protrusions 144. Thus, the barrel 264 is restrained from distal and proximal movement within the casing 108, while the plunger 268 is distally moveable via the plunger slider 1 18. Also as seen in the figure,the barrel 264 of the syringe 270 is positioned within the cartridge 122 such that the flange 266 of the barrel 264 abuts the proximal end of the cartridge 122. The annular flange 192 abuts against the distally-facing surface 174 of the protrusions 144. In this way, the cartridge 122 is locked in place within the casing 108. As seen in the image, the syringe cap 260 is fitted within the injector cap 1 16 and is also fitted around the needle 262. Also, the syringe cap 260 and injector cap 1 16 are fitted to the distal tube 114 to shield the needle 262 prior to use. As seen in the image, the biasing member 124 is positioned around the cartridge 122 and is coupled between the cartridge 122 and the lock ring 126.

[0169] FIG. 12B is a cross-sectional side view of the injector 100 of FIG. 12A with the injector cap 1 16 and syringe cap 260 (coupled thereto) removed from the distal tube 1 14. In this state, the needle 262 is shielded on the sides by the sidewall 206 of the distal tube 114. And since the distal tube 1 14 extends beyond the tip of the needle 262, the user is still shielded from accidental stick of the needle 262 prior to use. FIG. 12C is a cross-sectional side view of the injector 100 of FIG. 12B with the distal tube 114 retracted into the casing 108 as would occur during application of the distal tube 1 14 to the injection site of the user or patient. As seen in FIG. 12C, as the distal tube 1 14 retracts into the casing 108, the biasing member 124 is compressed between the lock ring 126 and the annular flange 192 of the cartridge 122. As described previously, the cartridge 122 is secured in place in the casing 108 and the syringe is secured within casing 108 (with the barrel 264 and needle 262 in a fixed position relative to the cartridge 122). As seen in FIG. 12C, the distal tube 1 14 is in a retracted position. In this position, the biasing member 124 is about fully compressed (no additional retraction is possible). In this state, the distal end 204 of the distal tube 1 14 is about flush with the distal end of the casing 108.

[0170] FIG. 12D is a cross-sectional side view of the injector 100 of FIG. 12C with the plunger slider 1 18 depressed distally so as to dispense the substance from within the barrel 264 of the syringe 270. FIG. 12E is a cross-sectional side view of the injector 100 of FIG. 12D with the distal tube 114 extended into the locked and extended position. Finally, FIG. 12F is a cross-sectional side view of the injector 100 of FIG. 12E with the injector cap 116 and syringe cap 260 returned to the distal tube 114.

[0171] It is noted that as the user applies the distal tub 1 14 to the injection site, the needle 262 enters the injection site as the tube 114 transitions from the extended state to the retracted state. In the retracted state, the needle 262 is positioned within the patient at the injection site. After dispensing of the drug from the syringe, the user pulls the injector 100 away from the injection site, which causes the distal tube 1 14 to extend into an extended and locked position.

[0172] FIGS. 13A-13D illustrate how the injector 100 facilitates single-use operation. That is, the injector permits a single retraction of the distal tube 1 14 and then locking of the distal tube 1 14 in the extended position. Stated differently, the injector 100 is a single-use device that restricts exposing the needle 262 following the first use. It is noted that the syringe 270 has been dispensed in the images of FIGS. 13A and 13C. The purpose of the figures is to demonstrate the locking mechanism associated with distal tube 1 14, casing 108, lock ring 126, and biasing member 124. As such, the positioning of the plunger slider 118 and the plunger 268 are immaterial to this particular discussion.

[0173] FIG. 13A is a side view of the injector 100 with the first casings 1 10 rotated away from the rest of the injector 100 so as to expose the internal components thereof. More particularly, the barrel 264 of the syringe 270 is positioned within the cartridge 122 and the flanges 266 are positioned within the recesses 172 of the casing 108. The cartridge 122 is secured within the casing 108 and is fixed in position via the annular flange 192 and the pair of projections 186. The biasing member 124 is coupled to the lock ring 126 and the annular flange 192 so as to bias the distal tube 1 14 in the extended position. The annular rim 210 of the distal tube 1 14 prevents further distal movement of the distal tube 1 14 relative to the casing 108. That is, the annular rim 210 prevent dislodgement of the distal tube 114 from the casing 108.

[0174] FIG. 13B is a close up and vertically flipped view of the track 148 defined in the first casing 110 with an image of the post 242 of the lock ring 126 positioned within the track 148. The image of FIG. 13B is flipped in order to simulate the movement of the post 242 relative to the track 148 when the first and second casings 1 10, 112 are coupled together. As seen in FIGS. 13A and 13B, the post 242 of the lock ring 126 is positioned at the start 158 of the track 148.

[0175] When provided to the user with a pre-filled syringe 270 therein, the post 242 of the lock ring 126 is positioned at the start 158 of the track 148, as shown in FIGS. 13A and 13B. As the distal tube 1 14 is applied to the injection site of the patient, the distal tube 114 retracts into the casing 108. This causes the post 242 of the lock ring 126 to move proximally along the first longitudinal section 150 of the track 148. The post 242 proximally retracts and is guided along the transverse section 152 of the track 148, as seen in FIGS. 13C and 13D.

[0176] FIG. 13C is a side view of the injector 100 with the first casings 110 rotated away from the second casing 1 12 and the rest of the internal components of the injector 100. FIG. 13D is a close up and vertically flipped view of the track 148 defined in the first casing 1 10 with an image of the post 242 of the lock ring 126 positioned within the track 148. The postbetween the start 158 and locking end 160 of the track 148. As described previously, when the post 242 enters the transverse section 152, the rotational bias of the biasing member 124 causes the lock ring 126 to rotate in the direction of the second longitudinal section 154. FIG. 13C shows the post 242 in the transition process through the transverse section 152.

[0177] In this position, the needle 262 is exposed and would be in the injection site of the patient. In this position, the user would dispense the drug from the syringe 270 by depressing the plunger slider 118, which is shown in FIG. 13C. At the most proximal retraction of the distal tube 114 relative to the casing 108, the post 242 would be positioned at the apex 272 of the track 148. In this position, when the user withdraws the injector 100 from the injection site, the distal tube 114 begins to extend. During this extension, the post 242 moves down along the second longitudinal section 154. If the distal tube 1 14 is permitted to fully extend, the post 242 encounters the end of the second longitudinal section 154, and the rotational bias of the biasing member 124 causes the post 242 to rotate into the transverse locking section 156 of the track 148. The biasing member 124 biases the post 242 into the end 160 of the track 148. The end 160 is defined by a trio of walls in which do not permit movement of the post 242. Therefore, the distal tube 1 14 is locked in the extended position.

[0178] In this way, the injector 100 can be used to dispense a drug one time before it is locked. That is, the injector 100 is provided for use that permits a single injection by the needle and a subsequent locking of the injector 100.

[0179] FIGS. 14-20 illustrate another embodiment of an injector 100 that includes many of the same components as the injector illustrated in FIGS. 1-13. In describing the injector 100 of FIGS. 14-20, reference will be made to similar or the same components as previously described. The disclosure is not intended to be limiting. And the components of the various embodiments can be combined or modified as needed.

[0180] To begin, reference is made to FIG. 14A, which is a front view of the injector 100 in an assembled state. The injector 100 extends between a proximal end 102 and a distal end 104 along a longitudinal axis 106. The injector 100 includes a casing 108, which may be constructed of multiple components to facilitate efficient manufacturing. As seen herein, the casing 108 includes a first casing 1 10, a second casing 112, and a third casing or casing cap 1 15. The first and second casings 1 10, 1 12 are the side portions and the third casing 1 15 is a cap that encloses the proximal end 106 of the injector 100. At the distal end 104, an injector cap 116 is coupled to the casing 108 via a rotated connection (i.e. , corresponding threads on the casing and internal portion of the cap 1 16). Other connections are possible including a press-fit I friction-fit. The injector cap 114 has an internal opening to receive and couple to the syringe cap of the syringe therein. The injector cap 1 16 encloses the retractable distal tube ortube 1 14 (not seen in FIG. 14A). The injector 100 also includes a plunger slider 1 18 that is coupled to the plunger of the syringe (i.e., which is internally located in the casing) and engageable by a user on the outside of the casing 108. The plunger slider 118 is fixed together with the plunger of the syringe such that movement of the plunger slider 118 causes corresponding movement of the plunger of the syringe. Thus, the plunger slider 1 18 can be depressed quickly or slowly, fully or only partially and medication will be dispensed correspondingly. This provides a user-controlled way to dispense the medication.

[0181] FIG. 14B is a close-up view of the graduation lines 400 on the casing 108 of the injector 100 and the indicators 402 on the plunger slider 1 18 pointing to a graduation line 400 that corresponds to a volume in the syringe within the injector 100. As seen in the figure, the casing 108 includes graduation lines 400 from 0.0 milliliters (mL) at the distal end of the slider slot 140 and 1.0 mL at the proximal end of the slider slot 140, and incremental numerical representations for each 0.1 mL, as well as lines for each 0.02 mL. The scale can be modified based on the size of the syringe within the injector 100. In FIG. 14B, the indicators 402 are outwardly projecting members that point to the 1 .0 mL graduation line 400, indicating that the syringe has 1.0 mL in it. In this particular embodiment, this is the largest volume for the syringe. As the plunger slider 118 is depressed, as described above in the embodiment of FIGS. 1-13, the plunger of the syringe is also depressed and, thus, the medicament within the barrel of the syringe is ejected out of the needle of the syringe. The outwardly projecting members of the indicators 402 may be differently shaped such as being a pair of outwardly projecting members in which the graduation lines 400 are identified between the pair of members. In certain embodiments, the pair of outwardly projecting members may be a pair of rings that extend around the periphery of the casing 108.

[0182] FIGS. 14C-14F are various exploded views of the injector 100. FIG. 14C is a bottom-up isometric and exploded view of the injector 100. FIG. 14D is a top-down isometric and exploded view of the injector 100. FIG. 14E is a front and exploded view of the injector 100. And, FIG. 14F is a side and exploded view of the injector 100. As seen in these figures, the injector 100 encloses a syringe 270 including a barrel 264 having a flange 266, a plunger 268, and a needle 262. The figures show the first casing 110, the second casing 112, the casing cap 115, the plunger slider 118, the tube 114, and the injector cap 1 16. These figures additionally show the syringe cap 260, the cartridge 122, the lock ring 126, the biasing member 124 (shown in additional detail in FIG. 10). As with the embodiment in FIGS. 1-13, the barrel 264 of the syringe 270 and the cartridge 122 are supported in a fixed position within the casing 108.

[0183] FIGS. 15A-15C are, respectively, isometric interior view, side interior view, and side outer view of a first casing 1 10. As seen in FIGS. 15A and 15B, the first casing 1 10includes an inner surface 142 that is generally cylindrical. From the proximal end and moving distally, the inner surface 142 includes a circumferentially, inwardly projecting ramp 404 that receives a feature of the third casing 1 15 and facilities the third casing 1 15 snapping into engagement with the first and second casing 1 10, 1 12. Just distal of the ramp 404 is an annular shelf 406 that extends further inward. The flange of the barrel of the syringe (not shown) is positioned just above or on the annular shelf and, thus, prevents distal movement of the barrel of the syringe once it is positioned in the casing. When the casing cap 115 is coupled to the first and second casings 1 10, 112, the distal end of the casing cap 1 15 compresses against the flange of the barrel of the syringe in order to secure the barrel in position within the casing 108. Stated differently, when the casing cap 1 15 is snapped into engagement with the first and second casings 1 10, 112, the distal end of the casing cap 1 15 and / or the tabs 418 contacts the flange of the barrel of the syringe and secures the flange in position against the annular shelf 406. In a central part of the first casing 110 is a first window 120 extending through the first casing 1 10 from the inner surface 142 to the outer surface 143. The first window 120 provides visualization of the contents of the syringe therein (e.g., verification that medication is in the syringe). Moving distally, the inner surface 164 includes a distally-facing shoulder 174 that extends inwards to the central opening for the barrel of the syringe. The cartridge 122 is positioned distal to the distal-facing shoulder 174 and cannot be moved proximally because the opening that is central to the distal-facing shoulder 174 is narrowerthan the cartridge 122. The distal-facing shoulder 174 includes an alignment slot 175 for receiving the outwardly extending section 193 of the cartridge 122. When the outwardly extending section 193 of the cartridge 122 is received in the alignment slot 175, the cartridge 122 is prevented from rotating within the casing 108. The inner surface 164 may also include tabs and / or protrusions 176 that jut outwards and are sized and shaped to couple with corresponding recesses on the first casing 1 10. The tabs and / or protrusions 176 facilitate assembly of the first and second casings 1 10, 112 by snapping together.

[0184] Moving distally, the inner surface 142 includes a track 148 that guides the lock ring (not shown) as the tube (not shown) is retracted and then extended again into a locked position. The track 148 is similar to the track described with reference to FIGS. 1-13, particularly FIGS. 3A, 13B and 13D. The track 148 includes a starting position 158, a retraction section 150, an extension section 154, and a transverse locking section 156 that ends at a terminus 160. At the terminus 160, the track 148 includes an opening 149 extending through the first casing 110 from the inner surface 142 to the outer surface 143. When the protrusion or post 242 of the lock ring 126 moves along the track 148 it moves in the retraction section 150 as the tube (not shown) retracts. As the post 242 moves through the extension section 154, the tube (not shown) begins to extend until it reaches the transverse locking section 156.At this point, the tube is maximally extended and is then rotated via the biasing member (not shown) to the terminus 160. At this point, the post 242 is positioned adjacent the opening 149, thus, providing visual indication that the tube is in a locked position. In this locked position, the tube cannot be retracted. As will be discussed with reference to FIG. 20, the post 242 of the lock ring 126 may be colored (e.g., red) and / or have additional markings on it indicating that the tube is locked and / or that the medication has been dispensed.

[0185] Distal of the track 148, is the distal opening 162. Between the distally-facing shoulder 174 and the distal opening 162 may be referred to as the distal chamber for housing the cartridge 122, the biasing member 124, the lock ring 126, and a portion of the tube 114. As seen in FIG. 15C, the outer surface 143 includes threads 408 at the distal end thereof for threadably engaging corresponding threads on an inner surface of the injector cap (not shown). Opposite the distal opening 162 is a proximal opening 163. The proximal opening 163 remains opened until enclosed via the third casing 1 15. As seen in FIGS. 15A-15C, the first casing 1 10 forms part of the slider slot 140, which is a linear section for movement of the plunger slider in a linear direction only. In other embodiments, the slider slot 140 includes a transverse (rotation) section as well. In certain instances, the slider slot 140 of the present embodiment may be modified to include a transverse section.

[0186] FIGS. 16A-16C are, respectively, isometric interior view, side interior view, and side outer view of a second casing 1 12. As seen in FIGS. 16A and 16B, the second casing 1 12 includes an inner surface 164 that is generally cylindrical. From the proximal end and moving distally, the inner surface 164 includes a circumferentially, inwardly projecting ramp 404 that receives a feature of the third casing 1 15 and facilities the third casing 1 15 snapping into engagement with the first and second casing 1 10, 112. The ramp 404 is continuous when the first and second casings 1 10, 1 12 are snapped together. Just distal of the ramp 404 is an annular shelf 406 that extends further inward. Again, this annular shelf 406 is continuous when the first and second casings 110, 112 are snapped together. The flange of the barrel of the syringe (not shown) is positioned just above the annular shelf and, thus, prevents distal movement of the barrel of the syringe once it is positioned in the casing. In a central part of the second casing 112 is a second window 121 extending through the second casing 1 12 from the inner surface 164 to the outer surface 145. The second window 121 provides visualization of the contents of the syringe therein (e.g., verification that medication is in the syringe).

[0187] Moving distally, the inner surface 164 includes a distally-facing shoulder 174 that extends inwards to the central opening for the barrel of the syringe. The cartridge 122 is positioned distal to the distal-facing shoulder 174 and cannot be moved proximally because the opening that is central to the distal-facing shoulder 174 is narrower than the cartridge 122. The inner surface 164 may also include tabs and / or protrusions 176 that jut outwards and aresized and shaped to couple with corresponding recesses on the first casing 110. The tabs and / or protrusions 176 facilitate assembly of the first and second casings 1 10, 1 12 by snapping together.

[0188] As seen in FIG. 16C, the outer surface 145 includes threads 408 at the distal end thereof for threadably engaging corresponding threads on an inner surface of the injector cap (not shown). The threads 408 are continuous on the first and second casings 1 10, 112 when the casings are coupled together. Opposite the distal opening 162 is a proximal opening 163. Both the distal opening 162 and the proximal opening 163 are continuous when the first and second casings 1 10, 112 are coupled together. The proximal opening 163 remains opened until enclosed via the third casing 1 15. As seen in FIGS. 16A-16C, the second casing 1 12 forms part of the slider slot 140 (i.e., one half of the slot), which is a linear section for movement of the plunger slider in a linear direction only. In other embodiments, the slider slot 140 includes a transverse (rotation) section as well. In certain instances, the slider slot 140 of the present embodiment may be modified to include a transverse section. While the casing is shown as being made up three casings, it can be constructed in a different number of casings as required for manufacturing, assembly, or safety concerns.

[0189] FIGS. 17A and 17B are, respectively, bottom-up isometric and top-down isometric views of a third casing or casing cap 1 15. The casing cap 115 includes a proximal body 410 that has a circular perimeter and is the most proximal part of the injector 100, located at the proximal end 102. The proximal body 410 includes a proximal end section 416 of the slider slot 140 that aligns with the portion of the slider slot (not shown) formed by the first and second casings 110, 1 12 when the first and second casings 110, 1 12 are coupled with the casing cap 1 15. A partial cylindrical sleeve 412 extends distally from the proximal body 410 and defines an opening 414 that is distal to the proximal end section 416. On an inner side of the partial cylindrical sleeve 412 are a pair of tabs 418, positioned opposite each other. The tabs 418 extend inward and are sized and shaped to receive the plunger slider (not shown) therebetween when the plunger slider is in its distal-most position (i.e., fully depressed). At a distal end of the partial cylindrical sleeve 412 and on an outer surface thereof is a lip 420 that extends circumferentially around the sleeve 412. The lip 420 is sized and shaped to snap underneath the ramp 404 on the first and second casings 1 10, 112 in order to secure the casing cap 1 15 to the assembled first and second casings 110, 1 12. As will be described in more detail in subsequent parts of this application, the casing cap 1 16 permits assembly of the first and second casings 1 10, 1 12, as well as many of the internal components of the injector 100, such that the plunger slider can be attached to the plunger of a pre-filled syringe and this subassembly can be top-loaded into the casing, and then the cap casing 1 15 can be attached to the first and second casings 1 10, 1 12 effectively enclosing the subassembly inplace and positioning it for use. In certain embodiments, the casing cap 1 15 includes an entirety of the slider slot 140 and an opening within the sleeve 412 that is opposite the slider slot 140. In this way, the plunger slider 1 18 may be positioned within the slider slot 140 and the end of the plunger of a syringe may be side loaded through the opening opposite the slider slot 140 and into engagement with the plunger slider 1 18. In such an embodiment, the slider slot 140 may extend a full length or nearly a full length of the sleeve 412. In such an embodiment, the first and second casings 110, 1 12 would not define the slider slot 140 there between.

[0190] FIGS. 18A and 18B are, respectively, top-down isometric and bottom-up isometric views of a plunger slider 1 18. The plunger slider 118 is engaged with the plunger of the syringe, which is housed or enclosed within the injector 100. As will be described in this application in reference to subsequent figures, the plunger slider 1 18 is distally depressible so as to dispense the substances within the syringe. As seen in the figures, the plunger slider 1 18 includes a cap 216 having a top surface 218, and a sidewall 220 coupled to the top surface 218. A cavity 222, as seen in FIG. 18B, is defined between the sidewall 220 and the top surface 218 for receiving the end of the plunger of the syringe therein. The cavity 222 communicates with an opening 221 in the sidewall 220 that permits sliding the plunger slider 1 18 onto the proximal end of the plunger of the syringe. The sidewall 220 also includes a pair of recesses 223 on opposite sides thereof. The recesses 223 are sized and shaped to fit within the tabs (not shown) that jut inward from the cylindrical sleeve (not shown) at the distal end of the cap casing 115 (not shown). In certain instances, the plunger slider 118 may not include the recesses 223.

[0191] Continuing on with FIGS. 18A and 18B, the plunger slider 1 18 includes an engagement structure 236 (thumb slider) coupled to the cap 216 via a stem (not visible in FIGS. 18A and 18B, but similarly shown in FIGS. 7D and 7E as the stem 234). The engagement structure 236 includes ridges for grip on a proximal-facing surface. The engagement structure 236 may include alternative shapes and sizes. The embodiment shown in the drawings is merely exemplary of an engagement structure 236. The plunger slider 1 18 is generally guided by the stem being positioned within the slider slot and by the shape of the sidewall 220 of the cap 216 being slideable within the cylindrical sleeve of the casing cap.

[0192] FIGS. 18C and 18D are, respectively, top-down isometric views of the injector cap 1 16 from two different rotational orientations. The cap 116 rotatably couples to the distal end of the injector 100 (i.e., the first and second casings 1 10, 112) and may be sized to also couple to a needle cap of the syringe (not shown) that covers the needle. Conventionally, pre-filled syringes are manufactured with a needle cap in place to guard the needle. In this way, the injector 100 can be assembled into an injector system in a sterile environment with the needlecap in place and with the cap 1 16 sized to couple to the needle cap. Then, upon removal of the cap 116 from the tube 1 14, the cap 1 16 also removes the needle cap.

[0193] The cap 1 16 includes an outer cylindrical surface 250 with ridges 256 for grip and an inner surface with threads 251 defined thereon. Within the outer cylindrical surface 250 is a tube 248 having for receiving the sterile syringe cap of the syringe. The tube 248 is sized and shaped (i.e., a pair of flat surfaces opposite each other) to receive the sterile syringe cap in a predetermined orientation. Extending upwards from one of the flat surfaces of the tube 248 is a guide 253 having a sloped or ramped surface that guides or otherwise rotates the sterile syringe cap of the syringe as it extends into the tube 248. The sterile syringe cap is attached to the syringe and covers the needle. The sterile syringe cap can rotate thereon. Thus, as the syringe is inserted into the injector 100 with the cap 1 16 attached to the injector, the sterile syringe cap can rotate into an orientation that permits insertion into the tube 248 of the cap 116. There is sufficient friction-fit between the sterile syringe cap and the tube 248 such that removal of the cap 116 from coupling with the casing 108 also removes the syringe cap from the syringe.

[0194] The biasing member 124 for the injector 100 of the present embodiment is similar or the same to the member illustrated in FIG. 10.

[0195] FIGS. 18E and 18F are, respectively, top-down isometric and bottom-up isometric views of a lock ring 126. The lock ring 126 is similar to the lock ring 126 illustrated and described in reference to FIGS. 8A-8C. The lock ring 126 includes a cylindrical sidewall 238 with a through-hole 240 extending from a proximal end to the distal end. Extending outward from the sidewall 238 in a direction perpendicular to a longitudinal axis of the lock ring 126 is a protrusion or post 242 of cylindrical shape. The protrusion 242 is sized and shaped to be received within and be guided by the track 148 on the inner surface 142 of the first casing 1 10 as described previously. The sidewall 238 of the lock ring 126 includes an outwardly extending section 245 with a bore hole 246 defined therein for receiving an end of the biasing member or spring 124. On a distal end of the lock ring 126, there are two recesses or slots 422, 424 in the sidewall 238. The smaller slot 422 is sized to provide space for the end of the biasing member 124 to extend through the bore hole 246 without interfering with the distal tube, which is positioned adjacent the distal end of the lock ring 126. The larger slot 424 is shaped and sized to receive the stop feature on the proximal end of the distal tube. In this way, limited rotational movement of the distal tube relative to the lock ring 126 is permitted, but not full rotation. It is noted that the lock ring 126 may be integrally formed with the distal tube 114. That is, the lock ring 126 and the distal tube 1 14 may be a single piece construction. As will be described subsequently, the post 242 may be marked in a way that indicates the injectoris locked when it is viewed through the opening 149 in the casing 108. The marking may be a color (e.g., red colored post), an insignia (e.g., arrow, X), or other marking.

[0196] FIGS. 18G and 18H are, respectively, top-down isometric and bottom-up isometric views of the distal tube 1 14. The distal tube 1 14 of the present embodiment is similar to the distal tube 114 illustrated and described in reference to FIGS. 6A-6D. As seen in the figures, the tube 1 14 includes a passageway 200 extending from a proximal opening 202 to a distal opening 204. The tube 114 includes a tubular surface 206 and coupling structure 208 at the proximal end. The coupling structure 208 includes an annular rim 210, a proximal projection 212, and a stop feature 213 extending over the annular rim 210 from the proximal projection. The coupling structure 208 is sized to receive the lock ring 126 thereon in an orientation where the stop feature 213 is positioned within the slot 424 of the sidewall 238 of the lock ring 126. The lock ring 126 can, thus, rotate within the confines of the slot 424. The distal end of the tube includes nubs 214 protruding distally from the distal rim of the tube 1 14. The nubs 214 abut the skin of the user when the injector 100 is applied to the patient. The nubs 214 function sensory stimulation to the user so the fear of needlestick is reduced.

[0197] FIGS. 181 and 18J are, respectively, top-down isometric and bottom-up isometric views of the cartridge 122. The cartridge 122 of the present embodiment is similar to the cartridge 122 illustrated and described in reference to FIGS. 5A-5E. The syringe is supported within the cartridge 122 and the cartridge 122 is supported in the casing 108 of the injector 100.

[0198] As seen in the figures, the cartridge 122 is a tubular body having a passageway 180 extending from a proximal opening 182 at the proximal end (top of image in FIG. 181) to a distal opening 184 at the distal end (bottom of image in FIG. 18J).

[0199] The cartridge 122 includes an annular flange 192 with a proximally-facing surface 194 that is generally perpendicular to a longitudinal axis of the cartridge 122. The proximally-facing surface 194 is joined by a distal-facing surface 196 that is generally parallel to the proximally- facing surface 194. When the cartridge 122 is positioned within the casing 108, the annular flange 192 abuts against the distally-facing shoulders 174 of the casing 108. This abutment prevents proximal movement of the cartridge 122 within the casing 108. When assembled, the cartridge 122 is biased proximally via the biasing member 124 (not shown), lock ring 126 (not shown), and tube 1 14 (not shown). In particular, the cartridge 1 12 is biased proximally, and the biasing member 124 also exerts a distal force on the lock ring 126 and tube 1 14. The lock ring 126 and tube 114 are prevented from further distal movement from the Thus, the cartridge 1 12, the biasing member 124, the lock ring 126, and the tube 1 14 are all moveably secured within the casing 108 with only the tube 1 14 extending partially out the distal opening 162. Assuch, once inserted into the casing 108, the cartridge 122 is prevented from both proximal and distal movement therein via interaction of the annular flange 192 with the distally-facing shoulders 174 (proximal movement) and by force from the biasing member 124, which is connected to the lock ring 126 (distal movement).

[0200] As seen in the figures, the annular flange 192 includes an outwardly extending section 193 in which couples to an end of the biasing member 124. In certain embodiments there are multiple (e.g., 2, 3) outwardly extending sections 193. The outwardly extending section 193 or the annular flange 192 may include a through-hole is sized to receive an end of the biasing member 124 (e.g., spring)(not shown). As described previously, the biasing member 124 exerts both a longitudinal force on the lock ring 126 and tube 1 14 in an outward or extended position, and a rotational force on the lock ring 126. The biasing member 124 is coupled to the cartridge 122 via the outwardly extending section 193, and the cartridge 122 is fixed in its position within the casing 108 as described previously.

[0201] FIGS. 19A-19E depict the injector 100 in various stages of use. FIG. 19A is a side view of the injector with the first casing 1 10 removed or opened up so as to view the internal components of the injector 100, prior to use. In use, the first casing 1 10 would be coupled to the second casing 1 12. The figures merely illustrate the casing 1 10 removed to view the operation of the injector.

[0202] As seen in FIG. 19A, the cap 1 16 is threadably connected to the casing 108. The first and second casings 1 10, 112 would be coupled together, and the casing cap 1 15 encloses the syringe within the casing. On the casing cap 1 15, the lip 420 has been snapped underneath the ramp 404 on the first and second casings 1 10, 112 in order to secure the casing cap 115 to the assembled first and second casings 1 10, 1 12. In this prior-to-use or ready-to-use state, the syringe is prefilled with a medicament and the plunger slider 118 is attached to the plunger (not seen) of the syringe. The flange 266 of the barrel 264 of the syringe is positioned just proximal of the annular shelf 406 and is prevented from distal movement via the shelf 406 and is also prevented from proximal movement by interaction with the casing cap 115. Depending on the volume of medicament within the syringe, the plunger slider 118 may be positioned at different points along the slider slot 140. In the illustrated embodiment, the plunger slider 1 18 is in a proximal-most position along the slider slot 140, indicating a max-fill for the syringe.

[0203] The cartridge 122 is supported in the casing 108 and the syringe is supported within the cartridge 122. The cartridge 122 is restrained from proximal movement via the distally- facing shoulder 174 on the casing 108. The cartridge 122 is restrained from rotation via the outwardly extending section 193 being positioned within the alignment slot 175 of the casing108. The biasing member 124 is engaged with the cartridge 122 and the lock ring 126. In particular, the biasing member 124 biases the cartridge 122 proximally and the lock ring 126 and tube 1 14 distally. And, in this state, the post 242 of the lock ring 126 is positioned within the track 148 at the starting position 158.

[0204] FIG. 19B is a side view of the injector 100 with the first casing 110 removed or opened up so as to view the internal components of the injector 100, with the syringe cap 116 removed so as to expose the tube 1 14. In this state, the injector 100 can be applied to an injection site of the patient.

[0205] FIG. 19C is a side view of the injector 100 with the first casing 110 removed or opened up so as to view the internal components of the injector 100, with the tube 114 in a retracted state and the needle 262 exposed. In this state, the distal tube 114 has been pressed against the injection site of the patient, thereby causing the distal tube 1 14 to retract and into the casing 108 and compress the biasing member 124. In this state, the post 242 of the lock ring 126 has moved within the track 148 from the starting position 158 through the retraction section 150. In this state, the user can inject the medicament from the syringe when they are ready. That is, the retraction of the distal tube 114 is not linked to injection of the medication. Instead, movement of the tube 1 14 and movement of the plunger slider 118 are independent of each other.

[0206] FIG. 19D is a side view of the injector 100 with the first casing 110 removed or opened up so as to view the internal components of the injector 100, with the plunger slider 1 18 moved distally in order to depress the plunger of the syringe (not shown) and eject the medication.

[0207] FIG. 19E is a side view of the injector 100 with the first casing 110 removed or opened up so as to view the internal components of the injector 100, with the tube 1 14 having been moved back into the extended state in which the needle is shielded. As the distal tube 1 14 transitions back into the extended state, the post 242 of the lock ring 126 moves through the transverse locking section 156 and to the terminus 160. In this extended state following retraction, the distal tube 114 is locked and cannot be retracted again.

[0208] In this state, as shown in FIG. 19E, the post 242 is positioned such that it is visible through the opening 149 in the casing 108. FIG. 20 is a close up side view of the distal end of the injector 100 with the casing 108 shown in phantom where the post 242 of the lock ring 126 is shown through the opening 149 in the casing 108. In this embodiment, the post 242 is marked with a color (e.g., red) that indicates the injector 100 has been used and is in a locked state or position.

[0209] FIGS. 21 -28 illustrate another embodiment of an injector 100. This injector 100 facilitates insertion of the needle into the subject and subsequent injection of the medicament in a single action from the user. The user still retains control of the speed of needle insertion as well as the speed of medicament injection. FIGS. 21A-21 B are, respectively, a pair of isometric top-down views of the injector 100 in two different rotational orientations. As seen in the figures, the injector 100 extends between a proximal end 102 and a distal end 104 along a longitudinal axis 106. The injector 100 includes a casing 108, which may be constructed of multiple components to facilitate efficient manufacturing. As seen herein, the casing 108 includes a first casing 110, and a second casing 112. A plunger cap 1 17 is attached to the plunger of the syringe (not shown in FIGS. 21A-21 B) and generally encloses the proximal end 102 of the injector 100. The plunger cap 1 17 is manually moveable in a distal direction relative to the casing 108 and in doing so depresses the plunger within the barrel of the syringe to dispense the medicament within the syringe. In this way, the plunger cap 1 17 and the casing 108 are collapsible relative to each other.

[0210] The first and second casings 1 10, 112 are the side portions and the plunger cap 1 17 encloses the proximal end 102 of the injector 100. At the distal end 104, an injector cap 1 16 is coupled to the casing 108 via a rotated connection (i.e., corresponding threads on the casing and internal portion of the cap 116). Other connections are possible including a press- fit / friction-fit. The injector cap 116 has an internal opening to receive and couple to the syringe cap of the syringe therein. The injector cap 116 encloses the retractable distal tube or tube 1 14 (not seen in FIGS. 21A-21 B).

[0211] As will be described subsequently in more detail, the plunger cap 117 is fixed together with the plunger of the syringe such that movement of the plunger cap 1 17 causes corresponding movement of the plunger of the syringe. The plunger cap 1 17 is initially in a locked state where it cannot be moved relative to the casing 108 to correspondingly move the plunger of the syringe and dispense the medicament. The plunger cap 1 17 transitions to an unlocked state where movement of the plunger cap 117 relative to the casing 108 in order to move the plunger of the syringe is permitted when the distal tube is retracted (transitions from the extended state to the retracted state). In this way, a user can apply the injector 100 to an injection site via application of force on the plunger cap 117 with the distal tube against the injection site. The distal tube will be caused to retract causing the needle to puncture the injection site, and then the injector 100 transitions the plunger cap 117 from the locked state to the unlocked state whereby the cap 117 is then moved distally to dispense the medication from the syringe into the injection site. The user can then retract the injector 100 causing the distal tube to extend and lock into place shielding the needle. Thus, the injection of themedication with the injector 100 is accomplished with a single application of force on the injector 100 to the injection site.

[0212] As seen in FIGS. 21A, 21 B, and 21 C, the injector 100 also includes a window 120 in the casing 108 to visualize the syringe and its contents from outside the injector 100. The casing 108 also includes an opening 149 (as described previously) in which the post 242 of the lock ring 126 is visible through opening 149 when the distal tube is in the locked and extended position (i.e., the post 242 is at the terminus of the track (not shown).

[0213] FIGS. 21 C and 21 D are, respectively, a side view and a cross-sectional side view of the injector 100. As seen in FIG. 21 D, the plunger cap 117 engages with the proximal end of the plunger 268 of the syringe 270. In this view, the plunger cap 117 is in the locked state where distal movement relative to the casing 108 is inhibited by the plunger cap lock ring 426 (shown in detail in FIGS. 25A-25C). More specifically, the plunger cap lock ring 426 has a pair of tabs 428 that positioned within a circumferential groove 430 in the plunger cap 1 17. Distal force on the plunger cap 117 causes the pair of tabs 428 of the plunger cap lock ring 426 to interact with the groove 430 in the plunger cap 117 and restrain movement relative to each other. The plunger cap lock ring 426 is rotatable within the circumferential groove 430, and is caused to rotate by the distal tube 114 moving into the retracted position (see FIG. 28C). When rotated, the tabs 428 of the plunger cap lock ring 426 are positioned vertically in alignment with a longitudinal groove 432 that intersects the circumferential groove 430 in the plunger cap 1 17. In this orientation of the plunger cap lock ring 426, the plunger cap 1 17 is in the unlocked state where distal movement relative to the casing 108 is permitted.

[0214] Still referring to FIG. 21 D, the barrel 264 and the needle 262 of the syringe 270 are in a fixed position within the casing 108 before, during, and after use of the injector 100. That is, the barrel 264 and the needle 262 do not move within the casing during movement of the plunger 268. The barrel 264 is supported within the casing 108 via the cartridge 122. The distal tube 1 14 is retractable relative to the casing 108 and around the cartridge 122. The biasing member is not shown in FIG. 21 D, but it would be positioned between the lock ring 126 and the cartridge 122 to bias the distal tube 1 14 in the extended position shown in the figure.

[0215] As seen in this figure, the sterile syringe cap 260 is both positioned over and coupled to the needle 262. The sterile syringe cap 260 is also coupled to the injector cap 1 16 such that when the cap 1 16 is uncoupled with the casing 108, the sterile syringe cap 260 will also be removed from the needle. As seen in this figure, the distal tube 1 14 is positioned within the injector cap 1 16, and a portion of the injector cap 116 is also positioned within distal tube 1 14.

[0216] FIGS. 22A-22C are, respectively, an isometric top-down and an exploded view of two-halves of a plunger cap 1 17, a side view of a first side 434 of the plunger cap 1 17, and a side view of a second side 436 of the plunger cap 117. The first and second sides 434, 436 of the plunger cap 1 17 facilitate ease of manufacturing and can be coupled together via the tabs 438 on the second side 436 and the corresponding recesses 440 on the first side 434. The plunger cap 117 includes a proximal surface 444, a sidewall 446 that is curvate and distally extending. The plunger cap 1 17 includes a distal opening 448 opposite the proximal surface 444. The plunger cap 117 also includes a distal surface 450 opposite of the proximal surface 444. The distal surface 450 includes a cavity 452 shaped and sized to receive the proximal end of the plunger therein.

[0217] Near the distal opening 448, the plunger cap 117 includes the circumferential groove 430, referenced in relation to FIG. 21 D. The circumferential groove 430 intersects the pair of longitudinal grooves 432 on opposite sides of the plunger cap 117. The longitudinal grooves 432 extend along an inner surface 454 of the plunger cap 1 17.

[0218] FIGS. 23A-23B are isometric top-down and isometric bottom-up views of the first casing 1 10 of the injector 100. The first casing 110 includes one half of the first or proximal annular shelf 406 that extends inward to a circular opening that permits the plunger of the syringe (not shown) to extend therethrough. The annular shelf 406 includes the proximal facing surface 456 that supports the plunger cap lock ring (not shown) thereon. The plunger cap lock ring can rotate on the proximal facing surface.

[0219] Moving distally, the casing 110 includes a second or distal annular shelf 458 that extends inward to a circular opening that permits the plunger of the syringe (not shown) to extend therethrough. The flange of the barrel of the syringe (not shown) can be positioned distal to the second annular shelf 458 and the shelf 458 includes indents to receive and support the flange of the barrel of the syringe in an orientation that inhibits rotation of the barrel.

[0220] Moving distally, the casing 1 10 includes a distally-facing shoulder 174 that extends inward from the inner surface 164 and is sized and shaped to inhibit proximal movement of the cartridge 122 (not shown) when positioned in the casing. The casing 110 also includes a first portion of the track 148 for guiding movement of the lock ring 126 (not shown) and distal tube 1 14 (not shown). When the first and second casings 110, 1 12 are coupled together, the first and second portions of the track 148 are continuous and uninterrupted. In other embodiments, such as those previously illustrated and described, the track 148 is formed solely on one of the casings 1 10, 1 12.

[0221] At the distal end, the casing 110 includes the distal opening 162. The outer surface 145 includes threads 408 at the distal end thereof for threadably engaging corresponding threads on an inner surface of the injector cap (not shown). The threads 408 are continuous on the first and second casings 110, 112 when the casings are coupled together. The distal opening 162 is continuous when the first and second casings 110, 112 are coupled together.

[0222] The inner surface 164 of the casing 110 may also include recesses 177 for receiving the tabs and / or protrusions 176 on the second casing 112. The recesses 177 and tabs and / or protrusions 176 facilitate assembly of the first and second casings 110, 112 by snapping together.

[0223] FIGS. 24A and 24B are, respectively, isometric top-down and isometric bottom-up views of the second casing 112 of the injector 100. The second casing 112 includes one half of the first or proximal annular shelf 406 that extends inward to a circular opening that permits the plunger of the syringe (not shown) to extend therethrough. The annular shelf 406 includes the proximal facing surface 456 that supports the plunger cap lock ring (not shown) thereon. The plunger cap lock ring can rotate on the proximal facing surface.

[0224] Moving distally, the casing 112 includes a second or distal annular shelf 458 that extends inward to a circular opening that permits the plunger of the syringe (not shown) to extend therethrough. The flange of the barrel of the syringe (not shown) can be positioned distal to the second annular shelf 458 and the shelf 458 includes indents to receive and support the flange of the barrel of the syringe in an orientation that inhibits rotation of the barrel.

[0225] Moving distally, the casing 112 includes a distally-facing shoulder 174 that extends inward from the inner surface 164 and is sized and shaped to inhibit proximal movement of the cartridge 122 (not shown) when positioned in the casing. The casing 112 also includes the second portion of the track 148 for guiding movement of the lock ring 126 (not shown) and distal tube 114 (not shown). When the first and second casings 110, 112 are coupled together, the first and second portions of the track 148 are continuous and uninterrupted. In other embodiments, such as those previously illustrated and described, the track 148 is formed solely on one of the casings 110, 112.

[0226] At the distal end, the casing 112 includes the distal opening 162. The outer surface 145 includes threads 408 at the distal end thereof for threadably engaging corresponding threads on an inner surface of the injector cap (not shown). The threads 408 are continuous on the first and second casings 110, 112 when the casings are coupled together. The distal opening 162 is continuous when the first and second casings 110, 112 are coupled together.

[0227] The inner surface 164 of the casing 1 12 may also include tabs and / or protrusions 176 that jut outwards and are sized and shaped to couple with corresponding recesses 177 on the first casing 110. The tabs and / or protrusions 176 and the recesses 177 facilitate assembly of the first and second casings 1 10, 112 by snapping together.

[0228] FIGS. 25A-25C are, respectively, a top-down isometric view, a bottom-up isometric view, and a side view of a plunger cap lock ring 426. The plunger cap lock ring 426 includes a tubular sidewall 460 and a pair of tabs 428 extending outwards from the sidewall 460. The pair of tabs 428 are sized and shaped to be positioned within the circumferential groove 430 (not shown) in the plunger cap 117 (not shown). A bottom surface 462 of the tubular sidewall 460 includes a linear section 464 and a curved section 466. The linear section 464 converges with the curved section at a pair of stop surfaces 468. As will be subsequently described in more detail and illustrated in reference to FIGS. 28A-28E, the plunger cap lock ring 426 is positioned on the first annular shelf 406 and is rotatable thereon. The plunger cap lock ring 426 is operably engaged with the lock ring 126 via an arm member 470 that extends proximally from the lock ring 126. As the lock ring 126 is moved through the track 148, the lock ring 126 translates and rotates thereby causing the arm member 470 to contact the curved section 466 of the plunger cap lock ring 426 and, because of the ramped or curved nature of the curved section 466, rotate the plunger cap lock ring 426 such that the tabs 428 are rotated within the circumferential groove 430 till they are in vertical alignment with the longitudinal groove 432 in the plunger cap 1 17, thereby permitting the plunger cap 117 to be distally depressed relative to the casing 108. Once the arm member 470 contacts the curved section 466 of the plunger cap lock ring 426, the arm member 470 rotates and ultimately contacts the stop surface 468, which then causes rotation of the plunger cap lock ring 426 to unlock the plunger cap 117. Other mechanisms are possible to link the lock ring 126 and the plunger cap lock ring 426 and contemplated herein such as, for example, a rigid connection between the lock ring 126 and the plunger cap lock ring 426.

[0229] FIGS. 26A and 26B are, respectively, a top-down isometric view, and a bottom-up isometric view of a cartridge 122 of the injector 100. The cartridge 122 is similar to and includes many of the same components as the cartridges 122 previously shown and described in reference to FIGS. 18I-18J and FIGS. 5A-5E. As with the other embodiments, the syringe is supported within the cartridge 122 and the cartridge 122 is supported in the casing 108 of the injector 100.

[0230] As seen in FIGS. 26A and 26B, the cartridge 122 is a tubular body having a passageway 180 extending from a proximal opening 182 at the proximal end (top of image in FIG. 26A) to a distal opening 184 at the distal end (bottom of image in FIG. 26B).

[0231] The cartridge 122 includes a partial annular flange 192 with a proximally-facing surface 194 that is generally perpendicular to a longitudinal axis of the cartridge 122. The proximally- facing surface 194 is joined by a distal-facing surface 196 that is generally parallel to the proximally-facing surface 194. In certain embodiments, the partial annular flange may be a fully circumferential annular flange 192 such as shown in FIGS. 18I-18J. When the cartridge 122 is positioned within the casing 108, the partial annular flange 192 abuts against the distally-facing shoulders 174 of the casing 108. This abutment prevents proximal movement of the cartridge 122 within the casing 108. As described with reference to FIGS. 181- 18J, the biasing member 124 exerts a proximal force on the cartridge 122 and the biasing member 124 also exerts a distal force on the lock ring 126 and tube 114. As such, once inserted into the casing 108, the cartridge 122 is prevented from both proximal and distal movement therein via interaction of the partial annular flange 192 with the distally-facing shoulders 174 (proximal movement) and by force from the biasing member 124, which is connected to the lock ring 126 (distal movement).

[0232] As seen in the figures, the partial annular flange 192 includes an outwardly extending section 193 in which couples to an end of the biasing member 124. The outwardly extending section 193 or the partial annular flange 192 may include a through-hole is sized to receive an end of the biasing member 124 (e.g., spring)(not shown). As described previously, the biasing member 124 exerts both a longitudinal force on the lock ring 126 and tube 114 in an outward or extended position, and a rotational force on the lock ring 126. The biasing member 124 is coupled to the cartridge 122 via the outwardly extending section 193, and the cartridge 122 is fixed in its position within the casing 108 as described previously.

[0233] FIGS. 27A and 27B are, respectively, a top-down isometric view, and a bottom-up isometric view of the lock ring 126 and arm member 470 of the injector 100. The arm member 470 is a linearly extending bar or arm that extends from the lock ring 126. The arm member 470 includes a free end 472 that contacts the plunger cap lock ring 426 and an opposite end 474 that is coupled to the lock ring 126. In certain embodiments, there are multiple arm members 470 (e.g., 2) extending from the lock ring 126. In certain embodiments, the arm member(s) may be coupled to the plunger cap lock ring 426 and the free end interacts with the lock ring 126 at the appropriate stage of use.

[0234] The lock ring 126 is the same as the lock ring 126 illustrated and described in reference to FIGS. 18E-18F. The lock ring 126 includes a cylindrical sidewall 238 with a through-hole 240 extending from a proximal end to the distal end. Extending outward from the sidewall 238 in a direction perpendicular to a longitudinal axis of the lock ring 126 is a protrusion or post 242 of cylindrical shape. The protrusion 242 is sized and shaped to be received within and be guided by the track 148 on the inner surface 142 of the first casing 110as described previously. The sidewall 238 of the lock ring 126 includes an outwardly extending section 245 with a bore hole 246 defined therein for receiving an end of the biasing member or spring 124. On a distal end of the lock ring 126, there are two recesses or slots 422, 424 in the sidewall 238. The smaller slot 422 is sized to provide space for the end of the biasing member 124 to extend through the bore hole 246 without interfering with the distal tube, which is positioned adjacent the distal end of the lock ring 126. The larger slot 424 is shaped and sized to receive the stop feature on the proximal end of the distal tube. In this way, limited rotational movement of the distal tube relative to the lock ring 126 is permitted, but not full rotation. It is noted that the lock ring 126 may be integrally formed with the distal tube 114. That is, the lock ring 126 and the distal tube 1 14 may be a single piece construction. As will be described subsequently, the post 242 may be marked in a way that indicates the injector is locked when it is viewed through the opening 149 in the casing 108. The marking may be a color (e.g., red colored post), an insignia (e.g., arrow, X), or other marking.

[0235] In another embodiment, the injector 100 may function without a plunger cap lock ring. In such an embodiment, the plunger cap 1 17 may include a distally extending arm member that extends within the casing towards the lock ring 126. The lock ring 126 would block distal movement of the arm member (and thus the plunger cap) until the lock ring 126 is appropriately positioned. The lock ring 126 may be a partial lock ring defining a C-shape or otherwise include an opening, a recess, or cutout its ring. The lock ring 126 may operate as described herein where it moves proximally (as the tube 114 retracts) and rotates as guided by the track 148. In this embodiment, when the lock ring 126 is at or near the apex 272 of the track 148 (corresponding to the tube 114 being retracted), the arm member extending distally from the plunger cap 117 would be in alignment with the opening in the partial lock ring such that distal movement of the plunger cap 1 17 relative to the casing 108 would be permitted thereby causing the arm member of the plunger cap 1 17 to extend through the opening in the lock ring 126 to dispense the medication in the syringe. The opening in the lock ring 126 is large enough to permit continued rotation (and extension) of the lock ring 126 and the tube 1 14 into the extended and locked position.

[0236] The distal tube 114 for the embodiment of the injector 100 shown in FIGS. 21A- 21 D is the same as the distal tube 1 14 shown and described in reference to FIGS. 18G and 18H. Thus, the drawings are not repeated in this part of the application.

[0237] FIGS. 28A-28E depict the injector 100 in various stages of use. FIG. 28A is a side view of the injector 100 with one half of the casing 108 and one half of the plunger cap 1 17 removed to show the internal components of the injector 100, prior to use. In particular, the second casing 1 12 (shown in FIGS. 24A-24B) and the second side 436 of the plunger cap 117 are removed from view. In use, the first casing 110 would be coupled to the second casing1 12 and the first and second sides 434, 436 of the plunger cap 117 would be coupled together. The figures merely illustrate the casing 1 12 and the second side 436 of the plunger cap 1 17 removed to view the operation of the injector 100.

[0238] As seen in FIG. 28A, the plunger cap 1 17 is engaged with the plunger 268 of the syringe 270. The plunger cap 117 is in a locked position because the plunger cap lock ring 426 is positioned in the circumferential groove 430 in the plunger cap 1 17. While the second side 436 of the plunger cap 1 17 is removed, it can be understood that the pair of tabs 428 of the plunger cap lock ring 426 would be positioned within the circumferential groove 430 in the plunger cap 117. As seen in the figure, the tab 428 would require rotation of about a quarterturn to be positioned within one of the longitudinal groove 432 that intersects the circumferential groove 430 in the plunger cap 1 17. It is only in this orientation that the plunger cap 117 is now in an unlocked position.

[0239] The plunger cap lock ring 426 is positioned on and can rotate on the annular shelf 406 that extends inward from the inner surface towards the longitudinal opening in the casing 108. It is noted that the plunger 268 of the syringe 270 extends through the plunger cap lock ring 426. And the flange 266 of the barrel 264 of the syringe 270 is supported just distal of the annular shelf 406.

[0240] The cartridge 122 is positioned in a distal chamber of the casing 108. More specifically, the partial annular flange 192 abuts against the distally-facing shoulders 174 of the casing 1 10. The arm member 470 of the lock ring 126 extends proximally from the lock ring 126 and the casing 108 is sized and shaped to permit the arm member 470 to move upwards and to rotate within the casing 108. The arm member 470 extends past the cartridge 122 and is not yet in contact with the plunger cap lock ring 426 when the plunger cap 117 is in the locked position.

[0241] In this locked position of the plunger cap 1 17 and prior to use of the injector 100, the protrusion 242 of the lock ring 126 is positioned at the start 158 of the track 148. The injector cap 1 16 is coupled to the threads 408 (not visible) of the casing.

[0242] FIG. 28B is a side view of the injector 100 with one half of the casing 108 and one half of the plunger cap 117 removed to show the internal components of the injector 100, with the syringe cap 116 removed so as to expose the tube 1 14. In this state, the plunger cap 1 17 is still in a locked position. The injector 100 is, however, ready to be applied to the injection site of the subject.

[0243] FIG. 28C is a side view of the injector 100 with one half of the casing 108 and one half of the plunger cap 117 removed to show the internal components of the injector 100, with the tube 114 in a retracted state and the needle exposed. In this figure, the tube 1 14 has beenapplied to the injection site of the subject causing retraction of the tube 1 14 into the distal opening of the casing 108. In this retracted position of the tube 114, the needle 262 has perforated the skin of the subject. Retraction of the tube 114 causes the lock ring 126 to move proximally within the casing 108 as guided by the protrusion 242 within the track 148. In moving proximally, the arm member 470 has also moved proximally and the free end 472 contacts the plunger cap lock ring 426, thereby causing it to rotate around a longitudinal axis of the injector 100. As seen in the figure, the plunger cap lock ring 426 has been caused to rotate about one quarter turn with the pair of tabs 428 being positioned within the circumferential groove 430 in the plunger cap 117.

[0244] When rotated fully rotated (as seen in FIG. 28C), the tabs 428 of the plunger cap lock ring 426 are positioned vertically in alignment with the longitudinal groove 432 that intersects the circumferential groove 430 in the plunger cap 1 17. In this orientation of the plunger cap lock ring 426, the plunger cap 117 is in the unlocked state where distal movement relative to the casing 108 is permitted.

[0245] FIG. 28D is a side view of the injector 100 with one half of the casing 108 and one half of the plunger cap 117 removed to show the internal components of the injector 100, with the plunger cap 1 17 moved distally in order to depress the plunger 268 of the syringe 270 and eject the medication. As seen in the figure, the plunger cap 1 17 has slid over the outer surface of the casing 108. In this way, injection of the medication can be performed with a single application of force on the plunger cap 1 17, which initially retracts the tube 1 14 within the casing 108 and then retracts proximal end of the casing 108 into the plunger cap 1 17. As seen in the figure, the injection of the medication occurs with the lock ring 126 in the retracted section 150 of the track at the apex thereof. Thus, transitioning of the plunger cap 1 17 from the locked position to the unlocked position occurs by proximal translation of the lock ring 126 and arm member 470. In other embodiments, the transitioning of the plunger cap 117 from the locked position to the unlocked position may occur via rotation of the lock ring 126 and arm member 470 or a combination of translation and rotation.

[0246] FIG. 28E is a side view of the injector 100 with one half of the casing 108 and one half of the plunger cap 117 removed to show the internal components of the injector 100, with the tube 1 14 having been moved back into the extended state in which the needle (not shown) is shielded. In this figure, the lock ring 126 has been moved through the extension section 154, the transverse locking section 156 and ended at the terminus 160, which locks the tube 1 14 from subsequent retraction. In this state, the injector cap (not shown) can be reapplied to the injector 100.

[0247] Exemplary assembly steps 500 of the injector 100 of FIGS. 14-20 are shown in the flowchart of FIG. 29A. At step 502, form a movement subassembly by engaging the biasing member 124 between the cartridge 122 and the lock ring 126 and tube 114. At step 504, form a casing subassembly by inserting the movement subassembly into a distal chamber of one of the first or second casings 110, 112, and then coupling the first and second casings 110, 112 together. This step may involve positioning the outwardly extending section 193 in the alignment slot 175 of the distally-facing shoulder 175 of the casing 108. This step may also include rotatably coupling the injector cap 116 to the distal end of the casing 108. At step 506, form a syringe subassembly by positioning a plunger slider within the slider slot of the casing cap, and engaging an end of a plunger of a pre-filled syringe with the plunger slider through an opening of the casing cap. At step 508, form the injector 100 by top-loading the syringe subassembly down and into the casing subassembly such that the flange of the syringe abuts the annular shelf 406 of the casing 108. The casing cap of the syringe subassembly will click into engagement and otherwise couple to the casing subassembly, which completes the assembly of the injector 100. During this step, the sterile syringe cap is received and rotated into position within the injector cap. Once inserted therein, it is coupled such that removal of the injector cap 116 also removes the sterile syringe cap from the needle of the syringe.

[0248] Exemplary assembly steps 600 of the injector 100 of FIGS. 21-28 are shown in the flowchart of FIG. 29B. At step 602, form a movement subassembly by engaging the biasing member 124 between the cartridge 122 and the lock ring 126 and tube 114. At step 604, form a casing subassembly by inserting the movement subassembly into a distal chamber of one of the first or second casings 110, 112, and then coupling the first and second casings 110, 112 together. This step may include rotatably coupling the injector cap 116 to the distal end of the casing 108. At step 606, form a syringe subassembly by positioning a plunger cap lock ring around the end of the plunger of the syringe, and sliding the plunger cap lock ring up to the flange of the barrel of the syringe. This step may also include coupling a plunger cap 117 with the end of a plunger of a pre-filled syringe. This step may also include ensuring that the tabs 428 of the plunger cap lock ring 426 are positioned in the horizontal groove 430 and, generally, intermediate of the longitudinal grooves 432. At step 608, form the injector 100 by top-loading the syringe subassembly down and into the casing subassembly such that the flange of the syringe abuts the annular shelf 406 of the casing 108. During this step, the sterile syringe cap is received and rotated into position within the injector cap. Once inserted therein, it is coupled such that removal of the injector cap 116 also removes the sterile syringe cap from the needle of the syringe.

[0249] As seen in reference to the injector in FIGS. 14-20, the plunger slider includes outwardly facing arrows or markers that correspond with a dosage indicator on the side of thecasing. For instance, the casing can be marked from 0.0 milliliter (mL) to 1.0 ml_. In another embodiment, the casing can be marked from 0.0 milliliter (mL) to 2.0 mL. In another embodiment, the casing can be marked from 1.0 milliliter (mL) to 2.0 mL. The casing may include different markings as appropriate for a give size of syringe used in the device. The markings on the external surface of the casing are sized and positioned to correspond with the increments of the medication that are typically located on the barrel of the syringe, and which is positioned distal from the plunger slider. The injector requires a linear depression of the plunger slider to dispense the medication from the syringe. In this way, the injector can be loaded with syringes of varying capacity without a redesign of the device. For example, the injector may be loaded with a syringe having 0.7 mL of a medication. Because the plunger slider couples to the end of the plunger of the syringe, the arrow of the plunger slider will line up with the 0.7 mL designation on the side of the casing. In another example, the same injector can be used with a syringe having 1 .0 mL of medication. The plunger slider would couple to the plunger of the syringe and the arrow on the plunger slider will line up with the 1.0 mL designation on the side of the casing.

[0250] In certain embodiments, instead of arrows that point to the fill capacity within the syringe, the plunger slider may include other types of indicators such as, for example, a pair of outwardly extending protrusions where the fill capacity marked on the casing can be seen between the pair of outwardly extending protrusions. Other types of indicators are possible and contemplated herein. In certain embodiments, all fill capacities that are more than those indicated by the marking on the plunger slider may be hidden or obscured by a part of the device.

[0251] As described herein, the plunger slider of FIGS. 14-20 can include a plunger connection structure and a user engagement structure. The plunger connection structure includes a solid top surface, a cylindrical side wall, and a partial lower surface. The engagement structure is sized and shaped to be depressed by the user’s thumb. The engagement structure is coupled to the plunger connection structure, in particular the side wall, via a stem. The plunger slider also includes an opening in the sidewall at a point opposite of the engagement structure. The bottom surface extending inward from the cylindrical side wall to define an open ring shape or c-shape. There is an undercut area between the bottom surface and the top surface such that the plunger connection structure can be slid onto and coupled to the plunger top (thumb press) at the proximal end of the plunger of the syringe. The plunger top is generally a flat disk with a circular perimeter / edge. The edge of the plunger top can be received within the undercut area of the plunger connection structure such that both top and bottom surfaces of the plunger top are sandwiched by the plunger connection structure. In this way, proximal and distal movement of the plunger can be controlled by theplunger slider. In certain embodiments, the plunger connection structure may be differently arranged while still coupling to the plunger top and contacting both top and bottom surfaces of the plungertop in orderto control proximal and distal movement of the plunger. For instance, the opening in the plunger connection structure may be positioned at different positions on the cylindrical side wall. In certain embodiments the plunger slider may be integrally formed with the plunger of the syringe. In this way, the plunger slider is an extension of the plunger, and thus the plunger is actuatable on the external side of the device.

[0252] During assembly of the injector, the pre-filled syringe may be loaded into one of the sides of the casing, either the first casing 110 or the second casing 112, and the plunger slider may be slidingly engaged with the plunger top of the plunger via a left-to-right or right- to-left movement. Then the plunger slider may be rotated such that the stem of the plunger slider is positioned within the slider slot of the casing. Then, the other side of the casing may enclose the syringe and plunger slider. First casing 110 and second casing 112 are subassembled together and coupled to the Distal Cap (twisted on). Then third casing 115 and plunger slider 118 can be couple to the plunger of the syringe which can then be inserted into the bottom assembly with casings 110 and 112 and distal cap.

[0253] Alternatively, the syringe can be top loaded into a casing subassembly made up of the first and second casings 110, 112 being coupled together, with the cartridge 122, biasing member 124, lock ring 126, and tube 114 being in the distal chamber of the injector 100. More particularly, the plunger slider can be coupled to the end of the barrel of the syringe, and the plunger slider can be positioned in the slider slot of the casing cap to form a syringe subassembly. Then the syringe subassembly can be slid down into the casing subassembly with the syringe subassembly sliding into position where the casing cap snaps into engagement with the first and second casings 110, 112.

[0254] The cylindrical side wall of the plunger may include a pair of nubs extending distally outward from points on either side of the stem. These nubs and the backside of the user engagement structure may slidingly contact the inner and outer sides, respectively, of the casing during distal / proximal movement of the plunger slider. The interaction of the nubs and the backside of the user engagement structure facilitate alignment of the plunger connection structure centrally within the inner volume of the casing, which reduces drag forces during distal / proximal movement of the plunger slider.

[0255] As seen in the figures, the engagement structure of the plunger slider includes a rounded front lip edge to prevent increased lateral force from the user’s thumb and prevent excess distal force necessary to administer the medication. The placement of the plunger slider relative to the casing provides an ergonomic grip for the user, a grip that is different thanusing a syringe by itself. With the device described herein the plunger slider, and the axis of depression thereof, is off-axis from the longitudinal axis of the device. And as seen in this application, the casing completely covers / encloses all parts of the barrel and plunger of the syringe.

[0256] The plunger slider slides within a plunger channel or slot, which is a linear opening defined in the casing. As seen in the figures, the channel is partially defined on each half of the casing. When the pair of casings are coupled together, the plunger channel is defined between the pair of casings. The channel permits the plunger slider to be at any position in the channel in order to accommodate syringes within the device with different amounts of medication therein. This allows for prescription specific fillings of the syringe used within the device. The plunger channel is of a sufficient length to permit the plunger slider to move distally until the plunger of the syringe reaches its terminus. That is, the plunger slider is not limited in its distal movement by the plunger channel; instead, the interaction between the plunger and the barrel of the syringe provides for the limits. In this way, the device ensures complete depression of the plunger into the barrel of the syringe so that all medication in the syringe is dispensed. While distal movement is not limited by the distal terminus of the plunger channel, the proximal terminus of the plunger may limit movement of the plunger that would cause dislodgement of the plunger from the barrel of the syringe. Positioning the proximal terminus of the plunger channel in this manner ensures a sterile environment for the medication in the syringe.

[0257] Stated differently, the plunger channel is of a length to prevent proximal movement that would dislodge the plunger from the barrel of the syringe, while being long enough in a distal direction to not interfere with plunger fully seating within the barrel of the syringe to fully dispense all medication. While this application describes a single plunger channel, it is contemplated that multiple channels may be utilized to provide additional stability during medication administration.

[0258] In certain embodiments, the plunger slider may be differently configured. As one example, the user engagement structure may include a sleeve that slides over the proximal end of the device. Such a design permits single motion administration of the drug, and may be beneficial for patients with physical impairments. In certain embodiments, the plunger sleeve may include more than one slot though the casing and which couples to the top end of the plunger. In certain embodiments, the plunger slider may include a finger hole to aid the user in delivering the injection.

[0259] As seen in the figures, the lock ring is positioned on the proximal end of the distal tube. The lock ring is in the shape of a ring with a band extending around a circular perimeter.A distal surface of the band has two openings or slots defined thereon. The proximal surface (surface facing the spring) is flat and includes an opening to receive an end of the biasing member (e.g., spring) therein. One of the openings in the distal surface is under the opening in the proximal surface for the biasing member. The distal surface of the lock ring abuts the proximal end of the distal tube. The proximal end of the distal tube includes a stop that is sized and shaped to be received in the larger opening on the distal surface of the lock ring, when the distal tube and lock ring abut each other. In this way, a limited amount of movement is permitted between the two components. In certain embodiments, the amount of permitted movement is the circumferential distance between the start position of the protrusion on the lock ring and the end / lock position of the protrusion.

[0260] The limited amount of movement between the distal tube and lock ring permits ergonomic and comfortable use of the device while also aiding in assembly. During assembly of the device, the distal tube can be used to manipulate the lock ring into the initial I unlocked position by depressing the distal tube and rotating the tube until the lock ring is appropriately positioned with the protrusion in the initial I unlocked position. Once the device is set with the protrusion in the initial I unlocked position, the distal tube is permitted a limited amount of movement relative to the lock ring. In this way, the distal tube can be depressed (e.g., during use to inject a medication) without rotating while permitting the lock ring to rotate through the track from the initial / unlocked position to the final I locked position. Having the distal tube not rotate during use provides for a comfortable use of the device for the patient.

[0261] With respect to the embodiment of the injector 100 in FIGS. 14-20, the three-part casing facilitates vertical or horizontal insertion of the pre-filled syringe into the device. When inserting the syringe vertically, fitting the top casing on the top of the device a distal force is used, which ensures proper alignment of the syringe within the device and alignment of the sterile needle cap within the cap at the distal end of the device.

[0262] The top casing or casing cap includes a cylindrical sidewall extending distally from the brim. The sidewall is fitted within the side casings and, together, the side and top casings provide a dual-thickness to provide further robustness to the design. In certain embodiments, the top casing may include a filler clip that occludes the proximal plunger channel gap to ensure the plunger slider cannot be positioned proximally of the starting dosage indicator (e.g., 1.0 ml_).

[0263] In certain embodiments, the device may include a plunger channel shield that is positioned between the casings and the plunger of the syringe. This shield would assist in providing a more sterile environment for the syringe in the device. The shield could be rotationally coupled to the inner side of the casings, for example, and may rotationally removefrom being positioned behind the plunger channel when the plunger slider is distally advanced. In an embodiment, the shield may include a spiraling, ramped surface at a proximal end and a horizontal bottom end. Thus, when the plunger slider is moved distally, the plunger slider pushes on the ramped surface and causes the shield to rotate, which, in turn, opens up the plunger channel for the plunger slider to move therein. In other embodiments, the shield may be a two-part structure that is biased to close against each other behind the plunger channel. The stem of the plunger slider may be positioned between the inner ends of the two-part structure such that distal movement of the plunger slider opens the gap between the inner ends.

[0264] In certain embodiments, the top casing or cap may be threadably secured to the side casings. A screw-on top casing may prevent premature and / or unintended removal of the cap.

[0265] The injector cap includes an upwardly extending protrusion that is positioned outward of the opening for the sterile cap of the syringe. The protrusion includes an angled proximal edge that guides the sterile cap of the syringe into the proper alignment in the device cap. The sterile cap of the syringe is rotatable on the needle of the syringe. As such, when the syringe is loaded into the device and moved distally into position, the protrusion on the cap of the device (which is secured to the device) contacts the sterile cap of the syringe and, if needed, the sterile cap is rotated into alignment with the opening in the cap of the device, which receives the sterile cap in a friction-fit arrangement.

[0266] The device in FIGS. 21-28 illustrates an exemplary prefilled syringe administration system with needle shielding functionality. The device operates via a single action from the patient to insert the needle into the injection site and administer the medication held within the prefilled syringe. By permitting needle injection and dispensing of the medication in a single motion, the patient is able to maintain control of the rates of needle insertion and medication ejection which both can be controlled independently. This type of control is not permitted by conventional autoinjectors. By allowing patients to control these two functions, the device allows for an ISO standard prefilled syringe to be integrated with it without any redesign of the device or the syringe. This contrasts with conventional autoinjectors, which often must undergo design changes to accommodate various medications due to medication variables such as viscosity, volume, and rate of administration. By removing the need to redesign the device to accommodate new medications, the device streamlines the integration process time and monetary costs.

[0267] The device in FIGS. 21-28 includes a two-part sub-assembly in which a prefilled syringe may be inserted into the device will receive a bottom half of the device, with needleshield locking mechanism preset. A top half of the device will function similar to the plunger slider described earlier in this application, except it can encompass the entire top-half of the outer casings. This sub-assembly allows forthe manufacturer to slide a single prefilled syringe into the device and enclose the syringe by simply combing the two device halves together, which streamlines assembly.

[0268] To achieve a seamless, single motion administration from the device in FIGS. 21- 28, the top half of the device will have a plunger sleeve which will function similar to the plunger slider described previously in this application, except that it will encompass the entire top half of the device outer casings. This allows for the patient to administer medication by gripping this sleeve with a fist (hand grip on the side of the device; not palming the top of the device), rather than a thumb, and pulling the device downward towards the injection site, moving the plunger sleeve distally to control medication ejection.

[0269] In order to prevent medication ejection from the device prior to needle insertion, ensuring appropriate tissue plane insertion, the needle shield of the device must be retracted, and expose the needle prior to the ‘medication lock’ releasing. Once the needle shield is retracted, the ‘medication lock’ allows the plunger sleeve to begin movement toward the injection site per the patient’s force.

[0270] In operation, the patient grips the device on the plunger cap and applies downward pressure on the injection site. Once the needle shield (i.e., distal tube) is fully retracted, the lock ring twists from its initial position to its apex in the track. This allows the arm member 470 that is connected to the lock ring 126 to interfere with a plunger cap lock ring causing the plunger locking ring to twist as the rod twists, pushing the ramped / sloped surface of the plunger locking ring to twist. Once both locking rings have fully twisted, the plunger will then be unlocked and can then be depressed. In the operation of using the device, all these functions operate seamlessly allowing the patient to depress the device in one motion to insert the needle and then eject the medication. After operation the needle shield will lock into place as described with reference to the device in FIGS. 1-13.

[0271] By gating these two functions, needle insertion must occur prior to medication ejection, but both functions still allow for patient control of the rate. Additionally, this single motion may help prevent patients from lifting the device away from the injection site prior to complete administration, a current problem with industry autoinjectors, as the increased force felt once bottoming out the syringe will directly indicate to the patient that the injection is completed. This end-point functions as a tactile indicator of injection completion, as opposed to an auditory or visual indicator, which could be more reliable for patients.

[0272] Post-use, the user may lift the device away from the injection site and the needle shield locking mechanism will activate, locking the non-sterile needle inside and preventing accidental needlestick injuries.

[0273] The foregoing merely illustrates the principles of the invention. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachings herein. It will thus be appreciated that those skilled in the art will be able to devise numerous systems, arrangements and methods which, although not explicitly shown or described herein, embody the principles of the invention and are thus within the spirit and scope of the present invention. From the above description and drawings, it will be understood by those of ordinary skill in the art that the particular embodiments shown and described are for purposes of illustrations only and are not intended to limit the scope of the present invention. References to details of particular embodiments are not intended to limit the scope of the invention.

Claims

CLAIMSWe claim:1 . An injector for use with a syringe having a plunger, a barrel, and a needle, the injector comprising: a cartridge configured to support the syringe at least partially therein; a casing including a casing distal opening, an inner surface, an internal volume, a slider slot extending through the tubular body, a side opening, and a track defined on the inner surface, the track including a starting position and a locked position, the side opening extending through the casing, the casing configured to support the cartridge and the syringe; a tube including a tube distal end, the tube slidably engaged with the cartridge and configured to be in an extended state and in a retracted state, wherein, in the retracted state, the needle of the syringe extends beyond the tube distal end and the casing distal opening; a plunger slider configured to engage the plunger of the syringe within the internal volume of the casing and extend through the slider slot of the casing, wherein movement of the plunger slider and the plunger of the syringe are fixed together; a ring supported by the tube and including a protrusion that is positioned at least partially within the track, the protrusion configured to be guided within the track from the starting position to the locked position, wherein, in the locked position, a portion of the ring provides visual indication through the side opening of the casing that the injector has been used; and a biasing member engaged with the cartridge and the ring so as to bias the ring axially and rotationally, the biasing member biasing the tube in the extended state.

2. The injector of claim 1 , wherein the portion of the ring in which provides visual indication through the side opening of the casing that the injector has been used comprises the protrusion.

3. The injector of claim 2, wherein the protrusion of the ring includes a marking providing the visual indication, the marking comprising at least one of a color or an inscription.

4. The injector of claim 1 , wherein the side opening extends through the casing to a section of the track.

5. The injector of claim 4, wherein the section of the track includes the locked position of the track.

6. The injector of claim 5, wherein the portion of the ring in which provides visual indication through the side opening of the casing that the injector has been used comprises the protrusion, and wherein the protrusion of the lock ring is obscured by the casing at the starting position on the track.

7. The injector of claim 1 , wherein the track includes an in-use portion positioned between the starting position and the locked position, the in-use portion including an apex corresponding to the retracted state of the tube.

8. The injector of claim 7, wherein the starting position and the locked position correspond to two instances of the extended state of the tube.

9. The injector of claim 1 , further comprising a distal cap configured to couple to the tube distal end of the tube, wherein the distal cap includes a tubular extension having an opening sized to receive and secure a needle cap of the syringe therein such that removal of the distal cap from the tube distal end of the tube also removes the needle cap from the syringe.

10. The injector of claim 9, wherein the distal cap includes an upwardly extending protrusion configured to rotate the needle cap of the syringe into alignment with the opening in the tubular extension of the distal cap during insertion of the syringe into the injector.

11. The injector of claim 1 , wherein the casing comprises a first portion and a second portion couplable to each other.

12. The injector of claim 11 , wherein the casing further comprises a third portion comprising a top end of the injector that is couplable to the first and second portions of the casing, the third portion including at least a portion of the slider slot defined therein.

13. The injector of claim 12, further comprising the syringe having the plunger slider coupled thereto, the syringe and plunger slider being top-loadable into the injector, and the third portion of the casing being couplable to the first and second portions of the casing in order to enclose the injector.

14. The injector of claim 1, wherein the plunger slider is configured to engage with the plunger of the syringe within the internal volume of the casing.

15. The injector of claim 1 , wherein the slider slot extends through a side wall of the casing.

16. The injector of claim 1 , wherein, in the retracted state, the needle extends beyond the tube distal end about 3 to 7 millimeters.

17. The injector of claim 1 , wherein, in the retracted state, the needle extends beyond the tube distal end about 10 to 15 millimeters.

18. The injector of claim 1 , further comprising the syringe.

19. The injector of claim 18, wherein the syringe comprises a 1 / 2 inch needle or a 5 / 8 inch needle.

20. A method employing the injector of claim 1 on a subject, the method comprising: applying the tube to an injection site of the subject, thereby causing the tube to be in the retracted state and the needle of the syringe to enter the injection site of the subject; distally advancing the plunger slider, thereby distally advancing the plunger of the syringe and dispensing a medicament within the syringe into the injection site of the subject, wherein movement of the plunger slider is independent of movement of the tube; and removing the tube from the injection site of the subject, thereby causing the tube to be locked in the extended state in which the needle is shielded by the tube.21 . An injector for use with a syringe having a plunger, a barrel, and a needle, the injector comprising: a cartridge configured to support the syringe at least partially therein; a casing including a casing distal opening, an inner surface, an outer surface, an internal volume, a slider slot extending through the casing, and a track defined on the inner surface, the casing configured to support the cartridge and the syringe, the outer surface including one or more markings indicating a volume of fluid in the syringe; a tube including a tube distal end, the tube slidably engaged with the cartridge and configured to be in an extended state and in a retracted state, wherein, in the retracted state, the needle of the syringe extends beyond the tube distal end and the casing distal opening; a plunger slider having a first portion configured to engage with the plunger of the syringe within the internal volume of the casing, the plunger slider having a second portion extending from the first portion and extending through the slider slot of the casing, the plunger slider including a third portion configured to be depressed by a user so as to cause depression of the plunger of the syringe, the plunger slider further includes a feature that identifies the one or more markings on the outer surface of the casing as the plunger slider moves throughthe slider slot, wherein, when the feature identifies the one or more markings on the outer surface, the volume of fluid in the syringe corresponds to the one or more markings; a ring supported by the tube and including a protrusion that is positioned at least partially within the track, the protrusion configured to be guided within the track; and a biasing member engaged with the cartridge and the ring so as to bias the ring axially and rotationally, the biasing member biasing the tube in the extended state.

22. The injector of claim 21 , wherein the one or more markings include graduation lines and volumetric information.

23. The injector of claim 22, wherein the volumetric information comprises measurements in milliliters.

24. The injector of claim 21 , wherein the feature of the plunger slider comprises a protrusion and the one or more markings are adjacent the slider slot.

25. The injector of claim 24, wherein the protrusion comprises a point.

26. The injector of claim 11 , wherein the one or more markings comprises a first marking corresponding to a maximum volume and a second marking corresponding to a minimum volume, and wherein, in an assembled and unused state of the injector, the feature of the plunger slider identifies a third marking of the one or more markings that is in between the first marking and the second marking.

27. The injector of claim 26, wherein the first marking corresponds to 1.0 milliliters (mL) and the second marking corresponds to 0.0 mL.

28. The injector of claim 26, further comprising a stop positioned in the slider slot proximal of the plunger slider so as to prevent proximal movement of the plunger slider within the slider slot.

29. The injector of claim 21 , wherein the casing further comprises a side wall, and the slider slot extends through the side wall of the casing.

30. The injector of claim 29, wherein movement of the plunger slider and the plunger of the syringe are fixed together.31 . An injector for use with a syringe having a plunger, a barrel, and a needle, the injector comprising: a cartridge configured to at least partially support the syringe therein along a longitudinal axis; a casing supporting the cartridge and the syringe therein, the casing including a casing distal opening, an inner surface, an internal volume, a slider slot extending through the casing, and a track defined on the inner surface; a tube including a tube distal end, the tube slidably engaged with the cartridge and configured to be in an extended state and in a retracted state, wherein, in the retracted state, the needle of the syringe extends beyond the tube distal end and the casing distal opening; a plunger slider having a first portion, a second portion, and a third portion, the first portion configured to engage with the plunger of the syringe within the internal volume of the casing, the second portion extending from the first portion and extending through the slider slot of the casing, the third portion positioned outside of the casing and configured to be depressed thereby causing depression of the plunger of the syringe, wherein depression of the third portion of the plunger slider is about an axis that is offset from the longitudinal axis; a ring supported by the tube and including a protrusion that is positioned at least partially within the track; and a biasing member engaged with the cartridge and the ring so as to bias the ring axially and rotationally, the biasing member biasing the tube in the extended state.

32. The injector of claim 31 , wherein, when the first portion of the plunger slider engages the plunger of the syringe, the first portion of the plunger slider is encased by the casing.

33. A method of operating a syringe safety device, the method comprising: providing the syringe safety device comprising: a syringe having a needle coupled to a barrel, and a plunger; a casing enclosing the barrel and the plunger of the syringe and comprising a distal opening, a slider slot extending through the casing, a track defined on an inner surface of the casing, and a side opening; a tube retractable at least partially within the distal opening of the casing to expose needle of the syringe; a ring engaged with the tube and the track in order to permit retraction of the tube, extension of the tube, and then locking of the tube in an extended-locked state; a plunger slider coupled to the plunger of the syringe and extending through the slider slot; retracting the tube; independently of retracting the tube, depressing the plunger slider so as to depress the plunger into the barrel of the syringe and dispense a fluid from the syringe; extending the tube;locking the tube in the extended-locked state; and providing a visual indication of the extended-locked state through the side opening in the casing.

34. The method of claim 33, wherein depressing the plunger slider comes from a force outside of the casing.

35. The method of claim 33, wherein the plunger slider is depressed along an axis that is offset from a longitudinal axis of the syringe enclosed within the casing.

36. The method of claim 33, wherein the ring includes a protrusion that is visible through the side opening in the casing when the tube is in the extended-locked state.

37. A method of assembling a safety syringe device, the method comprising: providing a syringe including a needle coupled to a barrel, a plunger engaged with the barrel, and a fluid in the barrel; providing a casing of a safety syringe device, the casing comprising a first side portion, a second side portion, and a third top portion; providing a cartridge for supporting the syringe within the casing, a tube for shielding the needle, a biasing member, and a ring; forming a first subassembly by slidably engaging the tube and the cartridge together with the biasing member and the lock ring positioned there between; coupling the first portion of the casing, the second side portion of the casing, and the first subassembly together, wherein a longitudinal slot is formed in one or both of the first and second side portions of the casing, the casing defining an inner volume; forming a second subassembly by attaching the plunger slider to a plunger top of the plunger of the syringe; forming a third subassembly by top-loading the second subassembly into the inner volume of the casing such that the plunger slider is positioned within the longitudinal slot; and attaching the third top portion of the casing to the third subassembly.

38. The method of claim 37, wherein attaching the third top portion of the casing to the third subassembly distally moves the syringe into a final position.

39. The method of claim 37, wherein the third top portion includes a sleeve that is slidably received within the first and second portions of the casing when the third top portion is attached to the third subassembly.

40. The method of claim 37, further comprising coupling a distal cap to at least one of the tube or the casing.

41. The method of claim 40, wherein attaching the third top portion of the casing to the third subassembly causes a sterile cap covering the syringe to be received in an opening of the distal cap.

42. The method of claim 41 , wherein the distal cap includes a feature that rotates the sterile cap into alignment with the opening of the distal cap.

43. The method of claim 42, wherein the distal cap is threadably coupled to the casing.

44. The method of claim 37, further comprising blocking the longitudinal slot in a position proximal of the plunger slider.

45. An injector for use with a syringe having a plunger, a barrel, and a needle, the injector comprising: a cartridge configured to support the syringe at least partially therein; a casing including a lower casing and an upper casing, the lower casing including a casing distal opening, an inner surface, an internal volume, and a track defined on the inner surface, the track including a starting position and a locked position, the casing configured to support the cartridge and the syringe, the upper casing including a top surface and a side wall extending downward from top surface, the upper casing configured to slide over at least a portion of the lower casing; a tube including a tube distal end, the tube slidably engaged with the cartridge and configured to be in an extended position and in a retracted position, wherein, in the retracted position, the needle of the syringe extends beyond the tube distal end and the casing distal opening; a first lock ring positioned between the upper casing and the lower casing, the first lock ring configured to transition from a first position and a second position, the first position preventing the upper casing from sliding relative to the lower casing, the second position permitting the upper casing to slide relative to the lower casing; a second lock ring supported by the tube and including a protrusion that is positioned at least partially within the track, the protrusion configured to be guided within the track from the starting position to the locked position, wherein, movement of the second lock ring causes the first lock ring to transition from the first position to the second position; anda biasing member engaged with the cartridge and the second lock ring so as to bias the second lock ring axially and rotationally, the biasing member biasing the tube in the extended position.

46. The injector of claim 45, wherein the casing further includes a side opening extending through the casing to the locked position of the track, wherein, in the locked position, the protrusion provides visual indication through the side opening of the casing that the injector has been used.

47. The injector of claim 45, wherein the first lock ring transitions from the first position to the second position via rotation.

48. The injector of claim 47, wherein the first lock ring includes a body including one or more tines extending outwardly therefrom, the upper casing including a first channel and a second channel, the one or more tines positioned within the first channel when the first lock ring is in the first position, the one or more tines positioned within the second channel when the first lock ring is in the second position.

49. The injector of claim 48, wherein the first channel is a horizontal channel extending around at least a portion of a circumference of an inner surface of the upper casing, the second channel is a vertical channel extending linearly along an inner surface of the upper casing.

50. The injector of claim 49, wherein the first channel and the second channel intersect each other.51 . The injector of claim 45, further comprising a member coupled to the second lock ring and configured to contact the first lock ring and cause the first lock ring to transition from the first position to the second position.

52. A method of operating the injector of claim 45, the method comprising: providing the injector of claim 45; retracting the tube so as to expose the needle of the syringe beyond the tube distal end and the casing distal opening, wherein retracting the tube causes: movement of the second lock ring; transitioning of the first lock ring from the first position to the second position; and depressing the upper casing relative to the lower casing thereby dispensing a fluid in the syringe.

53. The method of claim 52, further comprising extending the tube over the needle of the syringe; and locking the tube in the extended position.

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