Device and method for precision dose delivery

Abstract

To provide a device and method for delivering a predetermined volume of an active drug or other products including a fluid.SOLUTION: A device 1050 includes a body 1060 configured to receive an active drug therein, and a plunger rod 1080 disposed at least partially inside the body 1060 to distally move a stopper 1062 in the body 1060. The device 1050 includes a component configured to control distal movement of the plunger rod 1080 in a priming step and in a subsequent delivery step, so that the device 1050 may be accurately primed and may accurately dispense a predetermined volume of an active drug.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] Aspects of the present disclosure relate to devices and methods for priming or otherwise configuring a dose delivery device, such as a syringe, to facilitate accurate volume delivery. More specifically, embodiments of the present disclosure relate to devices and methods for filling, storing, transporting, and / or delivering an accurate dose of an active pharmaceutical ingredient or other fluidic substance.

Background Art

[0002] Pharmaceuticals containing a fluidic active pharmaceutical ingredient can be delivered to patients in a variety of ways, including by injection. In many cases, the accuracy and precision of the volume of a liquid pharmaceutical is of great importance. For example, healthcare professionals will be interested in ensuring that the approved or prescribed volume of the active pharmaceutical ingredient is consistently delivered to each patient in need of the drug. Further, over-dosing or under-dosing of the active pharmaceutical ingredient to a patient can have an undesirable (or negative) clinical impact on the patient, even if only slight. Additionally, some pharmaceuticals are prescribed at low volumes (e.g., less than 100 μL). At low volumes, human error in preparing and delivering an accurate dose of the injectable active pharmaceutical ingredient can affect the effectiveness of the drug in the patient and the subsequent clinical effect on the patient.

[0003] Additional aspects of liquid drug delivery can complicate the goal of accurate volume delivery by injection. For example, in order for the correct dose of the active pharmaceutical ingredient to be dispensed from a device (such as a syringe), the corresponding accurate volume of that substance must be filled into the device. Further, handling, storage, packaging, and / or transportation of the filled device must not cause accidental discharge of the active pharmaceutical ingredient from the device. Further, it may be necessary to prime the device, for example, to remove air bubbles and excess active pharmaceutical ingredient from within the needle and barrel of the device, prior to administration of the active pharmaceutical ingredient from the device. Improper priming of the device can cause either excessive or insufficient discharge of the active pharmaceutical ingredient from the device, which, in turn, can result in either a reduced dose being delivered to the patient or air bubbles being injected into the patient from the device.

[0004] The present disclosure also addresses needs not yet addressed by past publications (Patent Document 1 published on December 20, 2018, Patent Document 2 published on December 13, 2018, and Patent Document 3 published on December 13, 2018). Further, at least some embodiments of the present disclosure include features different from those disclosed in Patent Document 4 published on June 20, 2019. For example, some features include a plunger rod having one or more extensions extending distally from an actuating portion of the plunger rod and having a hook or clip-shaped portion for receiving a side opening of a flange piece. The plunger rod may include a neck having three or more sections each having a different cross-sectional profile and shape or cross-sectional profile or shape relative to one another. Further features may include, for example, a flange piece including a collar having one or more internal grooves for receiving a hook or clip-shaped portion of one or more extensions that allow the extension to bend radially outward from a pushed-in configuration to an extended configuration. The flange piece may include openings configured to receive each of the three or more sections of the neck, for example, based on a rotational arrangement of the plunger rod relative to the flange piece.

[0005] The flange piece of the present disclosure may further include either or both of one or more movable ribs and one or more movable tabs for engaging the syringe body to connect the flange piece to the syringe body. For example, one or more movable ribs may be disposed proximal to the lip and side openings of the flange piece to receive the upper flange of the syringe body. The movable ribs are capable of moving, flexing, and / or deforming in response to the reception of the upper flange through the side openings, and are configured to apply a distal force to the upper flange to fix the syringe body to the flange piece. In a further example, one or more movable tabs may be disposed distal to the lip and side openings. The movable tabs are capable of moving, flexing, and / or deforming in response to the reception of the flange piece by the syringe body, and are configured to apply a radial force to the syringe body to fix the syringe body to the flange piece. It will be understood that embodiments of the present disclosure include various other features described and explained herein that are different from the features disclosed in Patent Document 4.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Summary of the Invention

[0007] A drug delivery device is disclosed herein. In one embodiment of the present disclosure, the drug delivery device includes a body, a plunger rod disposed partially inside the body, a protrusion extending from the plunger rod, and a blocking component on the body. When the protrusion is in a first position relative to the blocking component, the blocking component restricts distal movement of the plunger rod to a first stop point, and when the protrusion is in a second position relative to the blocking component, the blocking component restricts distal movement of the plunger rod to a second stop point.

[0008] In some aspects of the present disclosure, the drug delivery device further includes a stopper disposed within the body. Distal movement of the plunger rod moves the stopper distally, and the drug substance is disposed between the stopper within the body and the distal end of the body. Distal movement of the plunger rod to the first stop point primes the drug delivery device, and distal movement of the plunger rod to the second stop point dispenses a predetermined volume of the drug substance from the distal end of the device.

[0009] In some aspects of the present disclosure, moving the protrusion from the first position to the second position includes turning the plunger rod relative to the blocking component. In some aspects of the present disclosure, the drug delivery device further includes a cavity proximal to the blocking component and sized to receive a portion of the protrusion. The protrusion is disposed proximal to the cavity such that distal movement of the plunger rod moves the protrusion into the cavity when the protrusion is in the second position relative to the blocking component.

[0010] In some aspects of the present disclosure, the cavity is the first cavity, and the drug delivery device further includes a second cavity on the proximal side of the blocking component, the second cavity being sized to receive a portion of the protrusion. The first cavity and the second cavity are located on opposite sides of the longitudinal central axis of the drug delivery device. In some aspects of the present disclosure, the blocking component includes a flange, is connected to the proximal end of the body, and the plunger rod passes through the opening of the blocking component. In some aspects of the present disclosure, the drug delivery device further includes an actuating portion at the proximal end of the plunger rod, and the protrusion extends from the actuating portion.

[0011] In some aspects of the present disclosure, the actuating portion includes a generally cylindrical shape having a diameter that exceeds the width of the remainder of the plunger rod. The protrusion extends from the side surface of the generally cylindrical shape, and the actuating portion further includes a thumb pad located at the proximal end of the actuating portion and a ring located on the outer surface of the side surface of the generally cylindrical shape. In some aspects of the present disclosure, the drug delivery device further includes a proximal collar on the blocking component, and the actuating portion is partially fitted inside the proximal collar.

[0012] In some aspects of the present disclosure, the plunger rod further includes a pair of extensions protruding distally from the actuating portion, and the blocking component includes a pair of openings. A portion of each extension is configured to be received by one of the pair of openings at the first stop point. In some aspects of the present disclosure, the blocking component includes one or more depressions formed along the bottom wall of the blocking component. A portion of each extension is configured to be received in one or more depressions after distal movement of the plunger rod relative to the blocking component to allow distal movement of the plunger rod to the second stop point.

[0013] In some aspects of the present disclosure, the blocking component includes a pair of internal grooves formed along the side walls of the blocking component. A portion of each extension is configured to be received by at least one of the pair of internal grooves after rotation of the plunger rod relative to the blocking component such that the extension expands radially outward from the pushed-in state to the relaxed state. In some aspects of the present disclosure, the protrusion is a first protrusion, and the drug delivery device further includes a second protrusion extending from the plunger rod in a direction opposite to the first protrusion. In some aspects of the present disclosure, the blocking component includes a pair of internal ribs configured to be slidably coupled to the body and to engage an upper flange of the body when the body is slidably coupled to the blocking component. The pair of internal ribs is configured to apply a distal force to the upper flange.

[0014] In some aspects of the present disclosure, the blocking component includes a pair of movable tabs configured to be slidably coupled to the body and to engage a sleeve of the body when the body is slidably coupled to the blocking component. The pair of movable tabs is configured to be deflectable laterally after receipt of the sleeve within the blocking component and to apply a radial force to the sleeve. In some aspects of the present disclosure, the blocking component further includes a pair of finger flanges. Each finger flange includes a textured surface having a predetermined pattern for improving the gripping force of the blocking component.

[0015] According to another embodiment of the present disclosure, the drug delivery device includes a plunger rod having a body, a proximal end having an operating portion with a distal end connected to a stopper inside the body and a thumb pad, a plurality of protrusions extending from the operating portion, and a blocking component disposed on the body, the blocking component including a proximal collar. When the protrusions and the blocking component are in the first configuration, the blocking component restricts the distal movement of the plunger rod to the first stop point, and when the protrusions and the blocking component are in the second configuration, the blocking component restricts the distal movement of the plunger rod to the second stop point. The proximal collar is configured to receive the protrusions after the distal movement of the plunger rod when the protrusions are in the second configuration.

[0016] In some aspects of the present disclosure, the protrusions and the blocking component are movable from the first configuration to the second configuration by rotation of the operating portion about the longitudinal axis with respect to the blocking component. In some aspects of the present disclosure, the difference between the first stop point and the second stop point is equal to the distance that the stopper must move to discharge a predetermined volume of the pharmaceutical from the distal end of the body. In some aspects of the present disclosure, the plurality of protrusions includes two protrusions symmetrically disposed around the operating portion. In some aspects of the present disclosure, the blocking component further includes a pair of finger flanges. In some aspects of the present disclosure, the drug delivery device is a prefilled syringe.

[0017] In some aspects of the present disclosure, a drug delivery device is convertible from a pre-use state to a primed state by longitudinally moving a plunger rod until it reaches a first stop point, (b) convertible from the primed state to a delivery state by rotating the plunger rod relative to a blocking component until the protrusion and the blocking component are in a second configuration, and (c) convertible from the delivery state to a used state by longitudinally moving the plunger rod until the plunger reaches a second stop point. In some aspects of the present disclosure, the plunger rod includes a neck disposed distally of the actuating portion, the neck interfacing with an opening of the blocking component to prevent proximal movement of the plunger rod. In some aspects of the present disclosure, the neck further interfaces with the opening of the blocking component to prevent movement of the drug delivery device from the delivery state to the primed state.

[0018] In a further embodiment of the present disclosure, the drug delivery device includes a body and a plunger rod, the plunger rod including a distal portion coupled to a stopper inside the body, a proximal end including a generally cylindrical actuating portion disposed outside the body, and two protrusions extending from opposite sides of the actuating portion in a symmetric configuration. The drug delivery device further includes a blocking component coupled to the body, the blocking component including a collar configured to receive the distal portion of the actuating portion, and two cavities within the collar having proximally facing openings. Each cavity is configured to receive the distal portion of one of the two protrusions. The plunger rod is longitudinally movable and rotatable about a longitudinal axis relative to the blocking component. When the drug delivery device is in the pre-use state, the protrusions and the cavity openings are not longitudinally aligned, and when the drug delivery device is in the delivery state, the protrusions and the cavity openings are longitudinally aligned. In some aspects of the present disclosure, the blocking component further includes a finger flange, and the drug delivery device further includes a ribbed surface on a side of the actuating portion.

[0019] In a further embodiment of the present disclosure, a method of dispensing a substance from a drug delivery device having a plunger rod and a body is disclosed. The method includes advancing the plunger rod a predetermined distance into the body until the advancement of the plunger rod is resisted by a stop, rotating the plunger rod about its longitudinal axis, and actuating the plunger rod to dispense a predetermined volume of the substance.

[0020] In some aspects of the present disclosure, actuating the plunger rod by advancing the plunger rod includes pressing an actuating portion of the plunger rod. In some aspects of the present disclosure, the plunger rod includes a protrusion and the stop includes a blocking component coupled to the body, the blocking component abutting the protrusion to resist advancement of the plunger rod.

[0021] In some aspects of the present disclosure, rotating the plunger rod includes screwing an actuating portion of the plunger rod relative to the blocking component of the plunger rod until a protrusion on the plunger rod is longitudinally aligned with a cavity within the blocking component. In some aspects of the present disclosure, actuating the plunger rod includes pressing an actuating portion of the plunger rod to advance the protrusion into the cavity.

[0022] In some aspects of the present disclosure, the method further includes advancing the protrusion into the cavity until the protrusion abuts a distal side of the cavity, and a predetermined volume of the substance is dispensed when the protrusion abuts the distal side of the cavity.

[0023] In a further embodiment of the present disclosure, the drug delivery device includes a body, a stopper disposed inside the body, and a sleeve having a proximal end and a distal end. The distal end is disposed proximal to the stopper inside the body. The device includes a plunger rod disposed at least partially inside the sleeve. When the stopper is in the ready position, any one of (a) the sleeve only, (b) the plunger rod only, or (c) both the sleeve and the plunger rod together advancing distally relative to the body advances the stopper to the primed position. When the stopper is in the primed position, another distal advancement of any one of (a) the sleeve only, (b) the plunger rod only, or (c) both the sleeve and the plunger rod together relative to the body advances the stopper to the administration complete position.

[0024] In some aspects of the present disclosure, the drug delivery device further includes a removable blocking component disposed between the proximal portion of the sleeve and the proximal end of the body. The blocking component prevents distal advancement of the sleeve relative to the body. Distal advancement of the sleeve relative to the body after removal of the blocking component advances the stopper to the primed position. The blocking component is a clip removably fixed around at least a portion of the sleeve.

[0025] In some aspects of the present disclosure, the drug delivery device further includes a removable lock component that couples the plunger rod to the sleeve. Distal advancement of both the sleeve and the plunger rod together relative to the body advances the stopper to the primed position. Distal advancement of the plunger rod only relative to the body after removal of the lock component advances the stopper to the administration complete position. At the administration complete position, the proximal end of the plunger rod abuts against the distal end of the sleeve so as to prevent further distal advancement of the plunger rod relative to the body. The removable lock component includes one of a pin, a tab, or a bar.

[0026] In some aspects of the present disclosure, the drug delivery device further includes a protrusion disposed on the plunger rod and an internal protrusion disposed on the inner wall of the sleeve distal to the protrusion of the plunger rod. Distal advancement of only the plunger rod relative to the body advances the stopper to the primed position and brings the protrusion of the plunger rod into contact with the internal protrusion of the sleeve. Distal advancement of both the plunger rod and the sleeve relative to the body advances the stopper to the administration complete position after the protrusion of the plunger rod contacts the internal protrusion of the sleeve.

[0027] In some aspects of the present disclosure, a pushable protrusion on the plunger rod and an opening disposed on the inner wall of the sleeve proximal to the protrusion on the plunger rod. Distal advancement of only the plunger rod relative to the body advances the stopper to the primed position. The sleeve is coupled to the plunger rod by pulling the plunger rod proximally until the pushable protrusion of the plunger rod enters the opening of the sleeve. Distal advancement of the coupled plunger rod and sleeve relative to the body advances the stopper to the administration complete position. In some aspects of the present disclosure, when the sleeve is coupled to the plunger rod, the total length of the combination of the sleeve and the plunger rod along the proximal-distal axis exceeds the length of the plunger rod alone.

[0028] In some aspects of the present disclosure, the sleeve includes a finger flange. In some aspects of the present disclosure, the drug delivery device further includes a stop disposed at the proximal end of the body. When the stopper is in the complete position, the stop is sized to prevent distal advancement of the sleeve or the plunger rod.

[0029] In further embodiments of the present disclosure, the drug delivery device includes a body and a plunger rod having a distal portion disposed within the body and a proximal portion disposed external to the proximal end of the body. The proximal portion has a width that exceeds the width of the distal portion. The device further includes an obstacle at an obstacle position relative to the plunger rod that prevents distal advancement of the plunger rod from a primed position to a dosing completed position. Movement of the obstacle from the obstacle position enables distal advancement of the plunger rod to the dosing completed position.

[0030] In some aspects of the present disclosure, the drug delivery device further includes a collar fixed to the proximal end portion of the body. The collar surrounds the proximal portion of the plunger rod. The drug delivery device further includes a collar protrusion extending radially inwardly from the collar. The proximal portion of the plunger rod includes a channel into which the collar protrusion projects and that includes a circumferential path and an axial dosing completed path. The obstacle includes the collar protrusion that prevents distal advancement of the plunger rod to the dosing completed position when disposed within the circumferential path of the channel. Movement of the obstacle from the obstacle position includes twisting the plunger rod about the longitudinal axis to align the collar protrusion with the axial dosing completed path.

[0031] In some aspects of the present disclosure, the channel further includes an axial priming path that is offset from the axial dosing completed path and is connected to the axial dosing completed path by the circumferential path. Distal movement of the plunger rod such that the collar protrusion moves within the axial priming path advances the plunger rod to the primed position. In some aspects of the present disclosure, the collar further includes a finger flange.

[0032] In some aspects of the present disclosure, the proximal portion of the plunger rod includes a protrusion extending radially outward. The drug delivery device further includes a rotatable alignment component disposed between the proximal portion of the plunger rod and the body. The alignment component includes a channel sized to receive the plunger rod protrusion. The obstruction includes a wall of the channel that blocks the distal axial path of the plunger rod protrusion when the plunger rod is in the primed position. Movement of the obstruction from the obstruction position includes rotating the alignment component to remove the wall of the channel from the distal axial path of the plunger rod protrusion.

[0033] In some aspects of the present disclosure, the drug delivery device further includes a finger flange coupled to the proximal end of the body. The rotatable alignment component is disposed between the finger flange and the proximal portion of the plunger rod. In some aspects of the present disclosure, the drug delivery device further includes a flange piece disposed at the proximal end of the body. The obstruction includes a removable cap that is partially disposed between the proximal portion of the plunger rod and the flange piece when in the obstruction position relative to the plunger rod. In some aspects of the present disclosure, removing the cap enables the proximal portion of the plunger rod to be advanced to the administration complete position. At the administration complete position, the proximal portion of the plunger rod contacts the flange piece. In some aspects of the present disclosure, the removable cap blocks the proximal portion of the plunger rod when in the obstruction position.

[0034] In some aspects of the present disclosure, the drug delivery device further includes a collar disposed between the proximal end of the body and the proximal portion of the plunger rod. The collar defines an opening sized to receive the proximal portion of the plunger rod after distal advancement of the plunger rod beyond the primed position. The obstruction includes a tab protruding radially outward from the proximal portion of the plunger rod that prevents the proximal portion of the plunger rod from fitting within the opening of the collar. The depth of the collar opening corresponds to the distance that the plunger rod must move distally to advance to the administration complete position.

[0035] In some aspects of the present disclosure, the movement of the obstruction from the obstruction position includes removing the tab or pushing the tab into the side surface of the proximal portion of the plunger rod. In some aspects of the present disclosure, the tab is a first tab, and the obstruction further includes a second tab that protrudes radially outward from the proximal portion of the plunger rod in a direction opposite to the protruding direction of the first tab. In some aspects of the present disclosure, the obstruction includes a tab disposed between the body and the proximal portion of the plunger rod when in the obstruction position. The plunger rod includes a geometric shape disposed proximal to the tab, and this geometric shape cannot advance distally past the tab when the tab is in the obstruction position.

[0036] In some aspects of the present disclosure, the movement of the obstruction includes removing the tab from the drug delivery device by pulling the tab. In some aspects of the present disclosure, the drug delivery device further includes a flange piece, and a part of the tab is disposed inside the cavity of the flange piece. In some aspects of the present disclosure, the movement of the obstruction includes removing the tab from the drug delivery device by breaking the tab.

[0037] In some aspects of the present disclosure, the obstruction includes a flange piece that is disposed proximal to the proximal end of the body between the proximal portion of the plunger rod and the body at the obstruction position and is spaced apart from the proximal end of the body by a removable blocking component. The movement of the obstruction from the obstruction position includes removing the blocking component and moving the flange piece distally relative to the proximal end of the body.

[0038] In some aspects of the present disclosure, the plunger rod includes a protrusion extending radially outward. The obstacle includes a lever having an end that is located distal to the protrusion at the obstacle position and that prevents distal movement of the plunger rod by preventing distal movement of the protrusion. Movement of the obstacle from the obstacle position includes moving the lever to remove the end of the lever distally from the protrusion at that position. In some aspects of the present disclosure, distal advancement of the plunger rod beyond the administration completion position is prevented by contact between the proximal portion of the plunger rod and a portion of a flange piece connected to the body.

[0039] In a further embodiment of the present disclosure, the drug delivery device includes a body and a sleeve fixed to the body. The sleeve includes a proximal end, a distal end, and an opening disposed within the circumferential wall of the sleeve. The drug delivery device further includes a plunger rod passing through the sleeve, the plunger rod including a distal end disposed inside the body and a protrusion extending radially. The plunger rod may be advanced distally into the body from a ready position to a primed position. At the primed position, the protrusion of the plunger rod is disposed inside the opening, and further distal advancement of the plunger rod is resisted by contact between the protrusion and the wall of the opening. Pressure may be applied to the protrusion to overcome the resistance to further distal advancement of the plunger rod.

[0040] In some aspects of the present disclosure, the opening in the sleeve is a second opening, and the sleeve further includes a first opening disposed within the circumferential wall of the sleeve proximal to the second opening and a third opening disposed within the circumferential wall of the sleeve distal to the second opening. At the ready position, the protrusion of the plunger rod is disposed inside the first opening, and further distal advancement of the plunger rod is resisted by contact between the protrusion and the wall of the first opening. After further distal advancement of the plunger rod past the primed position, the protrusion of the plunger rod is disposed inside the third opening, and further distal advancement of the plunger rod is prevented.

[0041] In some aspects of the present disclosure, the radially extending protrusion is a first protrusion, and the plunger rod further includes a second protrusion that extends radially on the side opposite the first protrusion. By applying an axial pressure in the distal direction to the plunger rod and compressing the first protrusion and the second protrusion toward each other, the resistance to further distal advancement of the plunger rod is overcome. In some aspects of the present disclosure, the proximal end of the sleeve includes a flare opening. Advancing the plunger rod distally from the ready position to the primed position involves advancing the protrusion through the sleeve into the flare opening, thereby pushing the protrusion between the interior of the sleeve and the plunger rod until the protrusion extends into an opening disposed within the peripheral wall of the sleeve. In some aspects of the present disclosure, the protrusion includes a distally tapered profile that aids in the distal advancement of the plunger rod.

[0042] In a further embodiment of the present disclosure, the drug delivery device includes a body, a plunger rod disposed within the body and including a distal end portion and a rotatable element, and a sleeve fixed to the body and including a proximal opening through which the plunger rod can be advanced. Rotation of the rotatable element results in distal advancement of the plunger rod to the primed position. When the plunger rod reaches the primed position, further rotation of the rotatable element is resisted.

[0043] In some aspects of the present disclosure, the rotatable element includes a cam lever. When the plunger rod reaches the primed position, the plunger rod may be pushed into the body to distally advance the plunger rod to the administration complete position. In some aspects of the present disclosure, the drug delivery device further includes a collar disposed at the proximal end of the body, the interior of the collar including a proximal threaded portion that forms a proximal helical path. The rotatable element includes a proximal portion of the plunger rod that includes a protrusion. The proximal portion of the plunger rod may be rotated about the longitudinal axis to distally move the protrusion along the proximal helical path. When the protrusion reaches the end of the proximal threaded portion of the collar, the plunger rod reaches the primed position.

[0044] In some aspects of the present disclosure, once the plunger rod is in the primed position, the plunger rod may be axially pushed into the body to distally advance the plunger rod to the administration complete position. In some aspects of the present disclosure, the interior of the collar further includes a distal threaded portion. The threads of the distal threaded portion are offset from the proximal helical path and form a distal helical path opposite the proximal helical path. Aligning the protrusion with the distal helical path positions the plunger rod in the primed position. Rotating the proximal portion of the plunger rod to move the protrusion distally along the distal helical path causes the plunger rod to distally advance to the administration complete position.

[0045] In a further embodiment of the present disclosure, the drug delivery device includes a body, a stopper disposed within the body, and a first plunger rod having a first proximal end and a first distal end that is narrower than the first proximal end. The first distal end has a first length. The drug delivery device further includes a second plunger rod having a second proximal end and a second distal end that is narrower than the proximal end. The second distal end has a second length. The drug delivery device further includes a finger flange fixed to the proximal end of the body. The finger flange has a through-hole that aligns with the proximal opening of the body. The through-hole is sized to accommodate each of the first and second distal ends but not either of the first or second proximal ends. Advancing the first distal end through the through-hole until the first proximal end abuts the finger flange pushes the stopper distally to the primed position. Advancing the second distal end through the through-hole until the second proximal end abuts the finger flange pushes the stopper distally to the administration complete position.

[0046] In a further embodiment of the present disclosure, a method of assembling a drug delivery device includes connecting a body to a blocking component that is a flange piece, disposing a plunger rod partially inside the body in an assembled state, and connecting the plunger rod to the blocking component such that proximal movement relative to the blocking component is inhibited. In the assembled state, the plunger rod is configured to engage a protrusion of the plunger rod with the blocking component and move distally relative to the blocking component to a first stop point, thereby discharging a priming dose of medicament from the body. When the protrusion is engaged with the blocking component, the blocking component is configured to limit distal movement of the plunger rod to the first stop point. The plunger rod is further configured to rotate relative to the blocking component when the plunger rod is at the first stop point, disengage the protrusion from the blocking component, move distally relative to the blocking component to a second stop point, engage the protrusion with the blocking component, thereby discharging a delivery dose of medicament from the body.

[0047] In some aspects of the present disclosure, the method further includes inserting an upper flange of a body into an opening of a blocking component, deflecting a tab of the blocking component radially outward, and deflecting a rib of the blocking component proximally. The tab applies a radially inward force to the body, and the rib applies a distal force to the upper flange to secure the body to the blocking component. The method further includes inserting an extension of a plunger rod into a side opening of the blocking component to attach the plunger rod to the assembled blocking component. The plunger rod is configured to deflect the extension radially inward such that the extension is removed from the side opening in response to moving the plunger rod distally relative to the blocking component to a first stop point. The extension is configured to move into the interior of the blocking component when rotating the plunger rod relative to the blocking component to align a protrusion with a slot of the blocking component. The extension flexes radially outward within the blocking component when the protrusion and the slot are aligned. The extension is configured to extend into a recess along the interior of the blocking component when the plunger rod moves distally to a second stop point.

[0048] The accompanying drawings, which are incorporated herein and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. The drawings show various aspects of the present disclosure, and where appropriate, like reference numerals are given to like structures, components, materials, and / or elements in different figures. In various embodiments, various combinations of structures, components, and / or elements other than those specifically shown are contemplated and are understood to be within the scope of the present disclosure.

[0049] In this specification, many embodiments are described and illustrated. The devices and methods described are not limited to any one of those aspects or embodiments, nor are they limited to any combination and arrangement or any combination or arrangement of such aspects and embodiments or aspects or embodiments. Further, each of the described aspects of the invention and their embodiments may be used alone or in combination with one or more of the other described aspects of the invention and their embodiments. For the sake of brevity, in this specification, specific sequences and combinations are not individually described and illustrated or described or illustrated.

Brief Description of the Drawings

[0050]

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DETAILED DESCRIPTION OF THE INVENTION

[0051] In this specification, many embodiments are described and illustrated. The present disclosure is not limited to any one of those aspects or embodiments, nor is it limited to any combination and arrangement or any combination or arrangement of such aspects and embodiments or aspects or embodiments. Each of the aspects of the present disclosure and both or one of their embodiments may be used alone or in combination with one or more of the other aspects of the present disclosure and both or one of their embodiments. For the sake of brevity, many of these combinations and arrangements are not described individually in this specification.

[0052] Embodiments of the present disclosure may be used in addition to, in combination with, or in addition to or in combination with aspects of International Application No. PCT / US2018 / 065192, filed December 12, 2018, which is hereby incorporated by reference in its entirety.

[0053] As used herein, the terms "comprises," "comprising," "includes," "including" or any other variation thereof are intended to cover a non-exclusive inclusion such that a device, process, method, article, or list of elements that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such device, process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal." In particular, embodiments or aspects described herein as "exemplary" or "examples" should not be construed as preferred or advantageous over other embodiments or aspects. Rather, it means that the embodiment reflects or shows that it is not "ideal" but one "example." Further, the terms "first," "second," etc. are used herein to distinguish one element, structure, step, or process from another, and do not denote any order, quantity, or importance. Further, the terms "a" and "an" are used herein to indicate the presence of one or more of the items being referred to, and do not denote a limitation of quantity. Further, the terms "about," "approximately," "substantially," etc., when used in connection with a numerical description, represent a variation of + / - 10% of that value, unless otherwise specified.

[0054] Embodiments of the present disclosure may be used with any type of liquid-containing product, such as a liquid active pharmaceutical ingredient, a liquid placebo, or other liquids that may be dispensed in a dosage form. As used herein, the term "active pharmaceutical ingredient" may refer to a formulated substance that contains an active ingredient, such as a small molecule or a large molecule, such as an analgesic, a steroid, or a biologic. As used herein, the term "biologic" may refer to a large molecule produced in a biological system, such as a cell (e.g., having a size greater than 15 kDa, greater than 30 kDa, greater than 50 kDa, greater than 75 kDa, or greater than 100 kDa). Biologics may include proteins (e.g., antibodies), nucleic acids, large sugars, and the like. Unlike small molecules, which will have a defined chemical structure, biologics may have highly complex structures that are not easily quantifiable by laboratory methods. As used herein, the term "pharmaceutical product" may refer to an amount of active pharmaceutical ingredient dispensed within a primary packaging component for packaging, transportation, delivery, and / or administration to a patient.

[0055] The term "primary packaging component" refers to a pharmaceutical packaging component, such as a drug container, designed and manufactured to make direct physical contact with the formulated active pharmaceutical ingredient. (See, e.g., "Guidance for Industry on Container Closure Systems for Packaging Human Drugs and Biologics" (May 1999) of the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research, which is incorporated herein by reference). Examples of primary packaging components include pre-fillable syringes, Luer syringes, cartridges, and vials made of glass, plastic, other polymers or copolymers, and / or other materials.

[0056] As used herein, the terms "distal" and "distally" refer to a position (or portion of the device) that is nearer to or in the direction of the patient delivery site, and the terms "proximal" and "proximally" refer to a position (or portion of the device) that is nearer to or in the direction of the user end opposite the distal position / portion of the device.

[0057] As used herein, when referring to a portion of the device, the term "body" may refer to a component suitable for containing an amount of the active agent. The body may include, for example, a barrel (such as a syringe barrel), a tube, a cylinder, or other things including a part of the device. In some embodiments, the body may also include a distal end having a nozzle, a needle, a needle attachment site, and / or a distal cap.

[0058] Embodiments of the present disclosure may be used with products that typically use small dosages, such as ophthalmic pharmaceuticals. In some embodiments, the device of the present disclosure may be used with pharmaceuticals that include macromolecules having a molecular weight of, for example, 30 kDa or greater. In some embodiments, the device of the present disclosure may be used with pharmaceuticals that include fragments of macromolecules. For example, in some embodiments, the device of the present disclosure may be used with pharmaceuticals that include antigen-binding molecules. In some aspects, the antigen-binding molecule may be an antibody or an antigen-binding fragment. In some embodiments, the device of the present disclosure may be used with, for example, aflibercept, alirocumab, abicipar pegol, bevacizumab, brodalumab, conbercept, dupilumab, evolocumab, tocilizumab, certolizumab, abatacept, rituximab, infliximab, ranibizumab, sarilumab, adalimumab, anakinra, trastuzumab, pegfilgrastim, interferon beta-1a, insulin glargine [rDNA origin], epoetin alpha, darbepoetin, filgrastim, golimumab, etanercept, any of the above antigen-binding fragments or combinations of such binding domains, for example, components such as bispecific antibodies particularly against VEGF or angiopoietin-2, and may be suitable for use with pharmaceuticals containing such components.

[0059] In some embodiments, the devices and aspects of the present disclosure can be used for the treatment of any eye disease, including the treatment of patients with diabetic eye disease, non-infectious endophthalmitis after injection, neovascular (Wet) age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). In particular, large and small molecule antagonists of VEGF and / or ANG-2, such as aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolucizumab), abicipar pegol (designed ankyrin repeating protein (DARPin) designed for PEGylation), RG7716, or fragments thereof (at any concentration). Intravitreal (IVT) administration of therapeutic agents may be an effective treatment for such eye disorders (e.g., macular degeneration, retinal vein occlusion, macular edema, retinopathy, etc.). However, IVT administration involves various challenges such as pharmaceutical development, administration procedures, and adverse events. For example, precise design of container components is required to provide accurate and precise delivery of small volumes (10 - 100 μL). Thus, dosing inaccuracies (e.g., over-dosing or under-dosing) can lead to undesirable adverse events or lack of efficacy, resulting in unpredictable and variable clinical responses.

[0060] In some embodiments, the devices and aspects of the present disclosure may also provide a container closure system for maintaining a drug in a sterile, stable, and safe state, increasing the intended shelf life and efficacy of the drug, while providing accurate dose delivery. Although IVT pharmaceuticals are primarily provided in glass vials, prefilled syringes provide more convenient administration by reducing the number of steps required for dose preparation. By pre-incorporating the drug within the device of the present disclosure, the steps required to prepare a dose for delivery to a patient may be minimized. Product development studies may focus on the characterization of primary container components, material compatibility with the formulation, formulation stability, fill volume determination, leachables / extractables, and final sterilization.

[0061] Furthermore, careful selection of auxiliary components such as disposable syringes and needles, and detailed administration procedures including administration instructions can ensure effective administration of the product. Despite many efforts in improving pharmaceuticals and administration procedures, concerns regarding eye safety such as the presence of endophthalmitis, increased intraocular pressure, and silicone floaters have been reported. The devices and aspects of the present disclosure may provide detailed administration procedures (such as priming instructions, administration instructions, etc.) to ensure effective administration of the drug to a patient in order to minimize such concerns regarding eye safety. In some embodiments, the devices and aspects of the present disclosure may also be used for cosmetic applications or in medical dermatology such as the treatment or diagnosis of allergic reactions.

[0062] In some embodiments, the devices and aspects of the present disclosure can be used to perform various eye injection procedures, such as, for example, intraocular therapy and surgeries including intravitreal injection of pharmaceuticals. The devices and aspects of the present disclosure can be used to dispense pharmaceuticals having various protein concentrations and viscosities or various protein concentrations or viscosities, including, for example, pharmaceuticals having a viscosity of from about 0.001 Pa·s to about 0.01 Pa·s (from about 1 centipoise to about 10 centipoise), from about 0.002 Pa·s to about 0.009 Pa·s (from about 2 centipoise to about 9 centipoise), from about 0.003 Pa·s to about 0.008 Pa·s (from about 3 centipoise to about 8 centipoise), from about 0.004 Pa·s to about 0.007 Pa·s (from about 4 centipoise to about 7 centipoise), or from about 0.005 Pa·s to about 0.006 Pa·s (from about 5 centipoise to about 6 centipoise). Pharmaceuticals having other viscosities are also contemplated. Providing an accurate dose by the devices of the present disclosure can be important when considering the possibility of variation in the protein concentration or viscosity of the pharmaceutical being delivered to the patient. The devices and aspects of the present disclosure can further be used to dispense pharmaceuticals having various volumes and amounts or various volumes or amounts, such as, for example, volumes in the range of from about 1 μL to about 200 μL, from about 10 μL to about 190 μL, from about 50 μL to about 150 μL, from about 75 μL to about 125 μL, from about 90 μL to about 110 μL, or about 100 μL. The devices of the present disclosure are configured, and can be used, to require a minimum force above a threshold to perform one or more procedures such as, for example, priming of the device, volume delivery, etc. By requiring a minimum force to be applied, the devices of the present disclosure facilitate control of the administration of a consistent dose of pharmaceutical, enhance safety by minimizing inadvertent movement of the components of the device, and thereby reduce the pain, discomfort, and injury to the patient.

[0063] For some products, particularly, for example, for ophthalmic or other pharmaceuticals, dosing accuracy can be particularly important. However, it is contemplated that the embodiments of the present disclosure are applicable to any other liquid product or any other situation where an accurate method for setting and administering a precise dose or delivery volume would be beneficial.

[0064] In some embodiments, the devices according to the present disclosure may be manufactured, packaged, filled, and / or otherwise prepared according to processes related to the products of which they are a part (e.g., pharmaceuticals). For example, in some embodiments, the devices according to the present disclosure may be sterilized before and after being filled and packaged or before and after being filled or packaged. For example, in some embodiments, the devices according to the present disclosure may be filled and packaged, for example, in blister packs and finally sterilized using any suitable method in the art, or may be filled and packaged, for example, in blister packs or finally sterilized using any suitable method in the art. For example, the devices according to the present disclosure may be finally sterilized using a chemical sterilization method such as a method involving ethylene oxide or hydrogen peroxide (e.g., hydrogen peroxide vapor). In some embodiments, the devices according to the present disclosure may be finally sterilized using, for example, the method described in International Application No. PCT / US2018 / 021013, filed on March 6, 2018, which is hereby incorporated by reference in its entirety.

[0065] Commercially available dosage delivery devices, such as syringes for use with prefilled syringes or vials, may not necessarily assist in accurately filling the required amount of a substance, priming the device, discharging excess volume of the active pharmaceutical ingredient from the device, and / or removing air bubbles from the device. In particular, in dosage delivery devices containing small volumes (e.g., about 500 μL or less, about 300 μL or less, about 250 μL or less, about 200 μL or less, about 150 μL or less, about 100 μL or less, about 50 μL or less, or about 25 μL or less, e.g., about 25 μL to about 50 μL, about 50 μL to about 100 μL, about 25 μL to about 100 μL, about 50 μL to about 150 μL, about 100 μL to about 250 μL, about 100 μL to about 150 μL, about 150 μL to about 250 μL, about 200 μL to about 250 μL, about 200 μL to about 500 μL, or about 250 μL to about 500 μL) of the active pharmaceutical ingredient, it may be difficult to visually confirm the presence of the correct dosage of the active pharmaceutical ingredient within the device. Currently, in the market for dosage delivery devices, particularly the syringe market, there is a need for a mechanism that enables a user to accurately set the delivery of small volume products in a syringe (e.g., prefilled syringe or fillable / refillable syringe), prime the syringe, remove air bubbles from the syringe, and / or confirm or ensure that the dosage in the syringe is correct. Embodiments of the present disclosure may assist manufacturers, pharmaceutical providers, medical professionals, and / or patients by accurately manufacturing, filling, or otherwise preparing a dosage delivery device, priming the device, removing air bubbles from the device, confirming the dosage, and / or administering a certain dosage from the device to a patient. Further, embodiments of the present disclosure may help prevent or reduce errors or variations in the manufacture or use of the device, such as errors or variations in the placement of dosage lines on the device, variations in the geometric shape of the device (e.g., variations in the geometric shape of the syringe neck), variations in the manufacturing tolerances of components, and / or variations or errors in the setting of dosage lines prior to delivery of the product.

[0066] In some examples, embodiments of the present disclosure may be particularly useful for individuals who have difficulty setting dosages with accuracy and precision. For example, embodiments of the present disclosure may assist the elderly, infants, or people with physical or mental disabilities in setting accurate dosages.

[0067] Various embodiments of the dosage delivery device, particularly syringes, are described herein. In some examples, the embodiments or aspects of embodiments disclosed herein may be used in combination with an existing syringe body portion to improve off-the-shelf products, thereby shortening the development and manufacturing time for the dosage delivery device. In other examples, the embodiments or aspects of embodiments disclosed herein may be included in the device during its manufacture. The syringes described herein may be pre-filled or fillable / refillable.

[0068] Embodiments of the present disclosure may include a syringe having rotational parts, threaded parts, springs, gears, detents, channels, grooves, etc. that enable a user to accurately control the movement of priming and dosage delivery elements, such as both or one of a plunger and a stopper, for example. These parts may be for the purpose of reducing human error, increasing accuracy, or both.

[0069] In some embodiments, a visualization device, such as a magnifying glass, may be provided, attached, or otherwise disposed on the delivery device to assist in enhancing the legibility of the dosage measurement markings of the device. It is contemplated that aspects of one embodiment (such as a sleeve, channel, blocking component, protrusion, detent, threaded part, grip, visual indicator, tactile indicator, or auditory indicator, etc.) may be combined with aspects of one or more other embodiments to create various combinations and arrangements of features in a single device.

[0070] In some embodiments, the device according to the present disclosure may be shown as including one type of plunger rod and plunger, or may be shown as including a schematic diagram of the plunger rod and plunger. For example, some of the devices according to the present disclosure may be shown or described as including a plunger rod having an end with a ball tip that engages a stopper such that the plunger rod and the stopper are attached to each other. For each of the embodiments disclosed herein, it is contemplated that a plurality of different configurations, or a plurality or different configurations of plunger rod and stopper may be appropriate. For example, in some cases, the above-described plunger rod with a ball tip may be used with the embodiments disclosed herein. In some embodiments, the plunger rod may not be fixed to the stopper. Instead, the pressure from the plunger rod against the stopper pushes the stopper, but the withdrawal, torsion or other movement of the plunger rod does not similarly withdraw, torsion or otherwise move the stopper, and it may be disposed close to, adjacent to, or attached to the stopper. As another example, in some embodiments, the plunger rod may be fixed to the stopper with a screw, clip, or adhesive, or may be a single part with a stopper (e.g., may be manufactured in a single mold with the stopper).

[0071] In some embodiments, the devices according to the present disclosure may include various appearance features related to the intended users of the devices. For example, the devices according to the present disclosure may be manufactured and sold for use by pediatric patients, elderly patients, or patients with physical disabilities. In such cases, the devices according to the present disclosure may include coloring, comic pictures or other appearance features that are appealing to children, or high-contrast coloring, textured surfaces, or other features to enhance identification and / or ease of use. In some cases, the devices according to the present disclosure may include letters, labels or other features designed to be easily recognized by the intended user. For example, pediatric devices, or devices for use by the disabled, physically handicapped or elderly, may have larger and more accessible labels that are easier for the user of the device to recognize and read. In some embodiments, the letters or labels may be raised, molded, or embossed.

[0072] Next, referring to FIGS. 1A-1E, diagrams and components of a delivery device 1050 are shown. The device 1050 includes a body 1060 and a blocking component in the form of a flange piece 1070 having a proximal collar 1072 surrounding an opening 1073 (such as shown in FIGS. 3B-3E), through which a plunger rod 1080 may enter the body 1060. The plunger rod 1080 includes an actuator 1082 that may be actuated (such as by pushing or turning) to rotate the plunger rod 1080 or move the plunger rod 1080 longitudinally within the body 1060. The actuator 1082 may be sized and configured to fit (such as nest or otherwise fit) within the proximal collar 1072.

[0073] The device 1050 may be, for example, an injection device such as a syringe for dispensing a formulation of a drug substance of a predetermined volume. In some embodiments, the device 1050 may be a prefilled syringe. For example, a user may receive an assembled and packaged device 1050 in a ready-to-use state in which an amount of the formulation of the drug substance is already disposed between a stopper 1062 within the body 1060 and a discharge end 1064 of the body 1060. In some embodiments, an air bubble (not shown) may also be disposed between the stopper 1062 and the discharge end 1064. In further embodiments, the device 1050 may be a refillable syringe.

[0074] The body 1060 may be any suitable body configured to hold and discharge a formulation of a drug substance of a predetermined volume. In some embodiments, the body 1060 may have, for example, a hollow cylindrical portion. The body 1060 holds a formulation of a drug substance of any suitable volume for delivery (e.g., to a patient) and is configured to discharge a predetermined volume of the held volume (e.g., through the discharge end 1064) during both or either of the priming step and the delivery step, together with other components of the device 1050. In some embodiments, the body 1060 holds a relatively small volume of the formulation of the drug substance (e.g., less than about 100 μl, such as less than about 80 μl, less than about 60 μl, less than about 40 μl, less than about 20 μl, less than about 10 μl, about 95 μl, about 90 μl, about 85 μl, about 80 μl, about 75 μl, about 70 μl, about 65 μl, about 60 μl, about 55 μl, about 50 μl, about 45 μl, about 40 μl, about 35 μl, about 30 μl, about 25 μl, about 20 μl, about 15 μl, about 10 μl, or about 5 μl) and is configured to discharge it together with other components of the device 1050. The device 1050 may be further configured to minimize the residual amount of the formulation of the drug substance remaining in the body 1060, together with other components, after a predetermined small volume has been delivered to the patient. In some embodiments, the body 1060 may be pre-filled (e.g., before assembly completion, packaging, sterilization, and / or shipment of the device 1050 to the user). In some embodiments, the stopper 1062 may be configured to hold a predetermined volume of the formulation of the drug substance inside the cavity of the body 1060.

[0075] The flange piece 1070 functions as a blocking component in the delivery device 1050 for closing, partially closing, plugging, or partially plugging the end of the body 1060 opposite the discharge end 1064, and for supporting and holding the plunger rod 1080 in place inside the body 1060, or for any of these purposes, and may be of any suitable size and shape or any suitable size or shape. In some embodiments, the flange piece 1070 may include a distal collar 1075 configured to engage the body 1060 and hold the flange piece 1070 in place relative to the body 1060. For example, the distal collar 1075 may include a lip 1071 that slides downwardly or otherwise relative to the body flange 1061 to hold the flange piece 1070 in place (e.g., slidably connect the flange piece 1070 to the body 1060). In an alternative embodiment, the lip 1071 of the distal collar 1075 may be made of a flexible or semi-flexible material so as to snap into place on the body flange 1061. In further embodiments, the distal collar 1075 or other portions of the flange piece 1070 may be affixed, molded, or otherwise secured to the body 1060, or may engage the body 1060 by friction fit.

[0076] The flange piece 1070 may be a blocking component or may include a blocking component. That is, a part or all of the flange piece 1070 may be sized and configured to control the movement of the plunger rod 1080 by preventing the movement of the plunger rod 1080 when the plunger rod 1080 is in a specific configuration relative to the flange piece 1070. For example, the flange piece 1070 may be configured to control the rotation and axial movement of the plunger rod 1080 by an opening 1073 (see, for example, FIGS. 3B-3E) that complements the size and shape of a part of the plunger rod 1080 (for example, both or one of the neck 1084 and the operating part 1082 and other parts of the plunger rod 1080 as shown in FIGS. 3I and 3M). As will be described in more detail herein, the flange piece 1070 may be formed of various materials having a minimum strength and rigidity or strength or rigidity that provides further control of the rotational or axial movement of the plunger rod 1080. For example, the flange piece 1070 may be configured to resist the proximal movement (or "pull-back") of the plunger rod 1080 (for example, to prevent disassembly of the device 1050 by retracting the plunger rod 1080) up to a predetermined force that is at least partially based on the material composition of the flange piece 1070. It will be understood that the flange piece 1070 may be configured such that when a force exceeding a predetermined force is applied, one or more of the flange piece 1070 and the plunger rod 1080 are broken, thereby rendering the device 1050 inoperable.

[0077] In a further example, the flange piece 1070 may be configured to resist rotational movement of the plunger rod 1080 up to a predetermined force, at least partially based on the material composition of the flange piece 1070 (e.g., to prevent accidental rotation). In addition and / or alternatively, the flange piece 1070 may be configured to resist translational movement of the plunger rod 1080 to control the rate of dose delivery, at least partially based on the material composition of the flange piece 1070 (e.g., to prevent accidental delivery). Various other components of the device 1050 other than the flange piece 1070 may include a material composition with frictional interference to prevent disassembly of the device 1050, accidental rotation of the plunger rod 1080, and / or accidental dose delivery.

[0078] The proximal collar 1072 of the flange piece 1070 may be sized and configured to receive a portion of the actuator 1082 of the plunger rod 1080 while preventing the protrusion 1086 of the plunger rod 1080 from moving distally beyond a predetermined position until the plunger rod 1080 is rotated to a particular position. As shown in FIGS. 1A and 1B, the collar 1072 may be cylindrical. In alternative embodiments, the collar 1072 may have any suitable size or shape that conforms to the actuator 1082. The collar 1072 may include a cavity, such as a slot 1074, that receives the protrusion 1086 of the plunger rod 1080 therein. The slot 1074 may have an opening facing proximally and may have a depth dimension parallel to the longitudinal axis of the device 1050. The number and configuration of the slots 1074 may correspond to the number and configuration of the protrusions 1086 of the plunger rod 1080. In some embodiments, the slots 1074 may be arranged around the collar 1072 in a radially symmetric configuration. In a further embodiment, the collar 1072 may include only one slot 1074. The depth of the slot 1074 may correspond to the distance that the plunger rod 1080 must move to push the stopper 1062 toward the discharge end 1064 and dispense a predetermined volume of the formulated drug substance from the body 1060 through the discharge end 1064. Advantageously, the predetermined volume of the formulated drug substance to be dispensed from the body 1060 may be controlled during manufacture, for example, by selecting a particular depth of the slot 1074. In some embodiments, the device 1050 may be configured such that normal variations in the manufacture of other components of the device 1050 (such as the body 1060 or the plunger rod 1080) do not result in variations in the volume of the formulated drug substance dispensed from the body 1060. Thus, the predetermined volume may be controlled simply by changing the manufacture of the flange piece 1070.

[0079] In some embodiments, the flange piece 1070 may include one or more flanges 1076 sized and configured to assist the user when holding the device 1050 and discharging the formulated drug substance from the device 1050, or when holding or discharging the formulated drug substance from the device 1050. In some embodiments, as shown in FIGS. 1A-1E, the flange piece 1070 may include two flanges 1076 that face each other and extend perpendicular to the longitudinal dimension of the device 1050. In some embodiments, the flange piece 1070 may include other arrangements of one or more flanges, such as four flanges extending radially outward from the longitudinal central axis of the device 1050 or one circumferential flange. In some embodiments, the flange piece 1070 may extend radially outward from the longitudinal central axis of the device 1050 further away from the perimeter of the body 1060. In such embodiments, the flange piece 1070 may support the device when the device 1050 is placed on a surface, may prevent the device 1050 from rolling on a flat surface, and / or may enable the device 1050 to be more easily picked up. In yet another embodiment, the aspect of the blocking component of the flange piece 1070 (e.g., the color 1072) may be separate from the flange piece 1070 such that the delivery device 1050 includes separate flange pieces and blocking components.

[0080] The plunger rod 1080 may be rotatable, for example, in one or both directions, generally about its longitudinal central axis. In some embodiments, rotation of the plunger rod 1080 may be achieved by gripping and twisting or gripping or twisting the actuating portion 1082 against both or one of the flange piece 1070 and the body 1060. In some embodiments, the protrusion 1086 provides an additional surface area for the user to grip and push or grip or push to twist the actuating portion 1082, thereby assisting the user in gripping and twisting or gripping or twisting the actuating portion 1082 against both or one of the flange piece 1070 and the body 1060. In some embodiments, only a portion of the plunger rod 1080, such as both or one of the actuating portion 1082 and the neck 1084, may be rotatable relative to both or one of the flange piece 1070 and the body 1060. In some embodiments, the plunger rod 1080 may be configured to rotate relative to the flange piece 1070 in response to applying a predetermined torsional force to the actuating portion 1082. The material composition of the flange piece 1070 may be a determining factor for the predetermined torsional force required to rotate the plunger rod 1080 relative to the flange piece 1070. For example, the flange piece 1070 may be formed of various materials having a predetermined stiffness that creates frictional resistance against the plunger rod 1080 to control the rotational movement of the plunger rod 1080 up to a predetermined force (e.g., to prevent accidental rotation / unexpected twisting of the plunger rod 1080). Further, the material composition of the flange piece 1070 may have frictional durability to control the distal translation of the plunger rod 1080 up to a predetermined force (e.g., to prevent accidental dose delivery by the device 1050).

[0081] The stem 1081 of the plunger rod 1080 may have any thickness and cross-sectional shape suitable for fitting into the body 1060 while maintaining robustness. For example, in some embodiments, the stem 1081 may have a thickness such that it can fit and slide along at least one dimension into the body 1060. Advantageously, such a thickness may help prevent unwanted wobbling of the plunger rod 1080 relative to other components of the device 1050. In further embodiments, the stem 1081 may have a thinner thickness while maintaining robustness (e.g., not bending, breaking, or deflecting during both or either assembly and use of the device 1050). In some embodiments, a portion of the stem 1081 may be configured to allow the plunger rod 1080 to rotate relative to the flange piece 1070, while other portions of the stem 1081 may not (see, for example, FIGS. 3I - 3Q).

[0082] The plunger rod 1080 may also include a distal end 1083 (see, for example, FIG. 1D) that is sized and configured to push against, attach to, or otherwise interface with the stopper 1062. The tip 1083 may have any size or shape suitable for achieving this purpose. In some embodiments, for example, the tip 1083 may be sized and configured to be retained by the stopper 1062 by an opening in the stopper 1062. In further embodiments, the tip 1083 may have a ball shape configured to fit into an opening in the stopper 1062. In yet another embodiment, the tip 1083 may include a plane parallel to the proximal face of the stopper 1062 and may be configured to push the stopper 1062 distally without attaching to the stopper 1062. In further embodiments, the tip 1083 may have a surface of any shape suitable for pushing the stopper 1062 distally.

[0083] In some embodiments, the neck 1084 of the plunger rod 1080 and the opening 1073 of the flange piece 1070 may have complementary geometric shapes that limit the degree and direction of rotation of the plunger rod 1080 (or a portion thereof) in accordance with both or either a particular longitudinal position and a rotational position of the plunger rod 1080 relative to the flange piece 1070. In some embodiments, the actuating portion 1082 of the plunger rod 1080 and the collar 1072 may include complementary geometric shapes that control the degree and direction of movement of the plunger rod 1080 relative to the flange piece 1070. For example, both or either the rotation and the longitudinal movement of the plunger rod 1080 may be limited based on the priming step, the preparation step, and / or the drug delivery step (see, e.g., the methods described with respect to FIGS. 3A-3F and the further methods / alternative methods described with respect to FIGS. 3G and 3H) of the method of using the device 1050 and the corresponding positions of the plunger rod 1080 with respect to each step of these methods. For example, when the device 1050 is assembled, the plunger rod 1080 may be limited from moving proximally out of (e.g., falling out or being pulled out of) the flange piece 1070. Further, the plunger rod 1080 may be limited from rotating about its longitudinal axis either before the device 1050 reaches a "primed" state, after the device 1050 reaches a "delivered" state, or both. Further, the proximal longitudinal movement (e.g., "backing out" of the plunger rod 1080) of the plunger rod 1080 may be limited by both or either the complementary geometric shape of the neck 1084 of the plunger rod 1080 and the opening 1073 of the flange piece 1070 and the complementary geometric shape of the actuating portion 1082 of the plunger rod 1080 and the collar 1072 of the flange piece 1070 after the device 1050 reaches either or both a "primed" state and a "delivered" state. Advantageously, this may prevent an undesired backing out of the plunger rod, for example, by securing to the stopper 1062, when the plunger rod 1080 is not held within the body 1060.For example, in some embodiments, the plunger rod 1080 may be configured to simply contact or lean against the stopper 1062 such that proximal movement of the plunger rod 1080 does not move the stopper 1062 proximally. In such a case, proximal movement of the plunger rod 1080 may be prevented by the interaction between the complementary geometric shapes of the plunger rod 1080 and the flange piece 1070. Further, the interaction between the actuating portion 1082 of the plunger rod 1080 and the collar 1072 of the flange piece 1070 may limit the longitudinal movement of the plunger rod 1080 in the distal direction. By way of example, the plunger rod 1080 may be restricted from moving distally after the "primed" state rather than before the "delivery" state.

[0084] To dispense the required amount of the active ingredient from the body 1060, after moving to the "delivery" state, the protrusion 1086 of the actuating part 1082 may be longitudinally aligned with the slot 1074 of the collar 1072 to allow distal movement of the plunger rod 1080. Thus, the plunger rod 1080 may include the number and configuration of the protrusions 1086 such that each protrusion 1086 can move distally within the slot 1074 when the plunger rod 1080 is in a specific position (e.g., the "delivery" state). In some embodiments, one, two, three, or more protrusions 1086 may extend from the actuating part 1082 corresponding to one, two, three, or more slots 1074, respectively. For example, as shown, two protrusions 1086 may extend from the side surface of the actuating part 1082 in a radially symmetric configuration (corresponding to the two slots 1074 in the collar 1072). In some embodiments, the radial symmetry of the plurality of protrusions 1086 (and slots 1074) may advantageously allow the protrusions 1086 to fit into the slots 1074 in a plurality of configurations (e.g., depending on whether the actuating part 1082 is twisted in one direction or the other). In such embodiments, the actuating part 1082 may be twisted in either direction, for example, based on user preference, right-handed or left-handed, or other factors. In some embodiments, the plunger rod 1080 shall not be pulled proximally out of or backed out from the body 1060 (e.g., toward the actuating part 1082) after the plunger rod 1080 has been "primed" and after the required amount of the formulated active ingredient has been delivered from the device 1050 by pushing the plunger rod 1080 into the body 1060 (e.g., by the geometric shape of both or either of the neck 1084 and the opening 1073), or either of them.

[0085] In some embodiments, the device 1050 may be configured to facilitate use and may include one or more features to assist the user by providing tactile or visual feedback. For example, one, two, or more components of the device 1050 may have contrasting colors or textures. In some embodiments, for example, the flange piece 1070 may have a different coloring than the plunger rod 1080. As a further example, one component of the device 1050 may have two or more colors or textures. In some embodiments, for example, the actuating portion 1082 may include a first color on the distal portion of the actuating portion 1082 that is covered by the color 1072 when the device 1050 is primed, to assist in indicating to the user that the device 1050 is properly primed, and may include a second color on a second portion of the actuating portion 1082 that moves adjacent to the color 1072 when the device 1050 is primed. As a further example, in some embodiments, the flange piece 1070 may have a tactile feel different from both or either of the plunger rod 1080 and the body 1060. For example, the flange piece 1070 may be relatively rough or relatively smooth compared to both or either of the plunger rod 1080 and the body 1060. As yet another example, one or more components of the device 1050 may have a texture that aids in holding, gripping, identifying, or using the device 1050. For example, the flange piece 1070 may have a slightly rough texture or a raised texture to help the user grip the flange 1076 and to prevent the user's finger from slipping off the flange 1076 during use, or for any of those purposes. In some embodiments, a part or all of the flange piece 1070 may have a smooth surface. As another example, the actuating portion 1082 of the plunger rod 1080 may include a rough texture or a raised texture that aids in gripping and rotating the plunger rod 1080. For example, as shown in FIGS. 1A-1I, FIGS. 2A, 2B, and FIGS. 3A-3H, the actuating portion 1082 may include circumferential ribs on its side surface.The actuating portion 1082 may have any suitable number of ribs on its side surface to provide texture. In a further embodiment, the actuating portion 1082 may not have ribs on its side surface.

[0086] In some embodiments, the device 1050 or one or more of its components may include a color, label, or marker that indicates the contents or state of the device 1050 and conveys or provides an instruction to the user of the device 1050, or that indicates or conveys or provides an instruction to the user of the device 1050 regarding the contents or state of the device 1050. Examples include one or more labels indicating a priming position relative to a dosing delivery position of the plunger rod, one or more labels indicating a direction to rotate or otherwise move the plunger rod 1080, and / or one or more labels (such as a linear indicia on the body 1060) indicating an amount of a formulated active pharmaceutical ingredient included in the device 1050. The label may be adhered or printed, for example, on a component of the device 1050, or may be embossed on a component of the device 1050 or formed as part of the device 1050. In some embodiments, one or more textured labels (such as embossed or formed on the device 1050) may also serve as a textured, rough, or raised surface that aids the user during gripping or use of the device 1050. One or more exemplary labels may include words, numbers, indicators, and / or symbols (such as lines, padlocks, arrows, diagrams, etc.).

[0087] In some embodiments, the device 1050 may be configured to emit one or more sounds during its use. For example, the device 1050 may emit a "click" noise after completion of the priming step or after rotation of the plunger rod to a position suitable for dispensing a predetermined volume of the formulated active ingredient. The "click" noise may be generated, for example, by friction between two or more components (such as the plunger rod 1080 and the flange piece 1070) or by contact between a part of one component and another part (such as the contact between the neck 1084 of the plunger rod 1080 and the opening 1073 of the flange piece 1070). In some embodiments, the device 1050 may include one or more detents or protrusions on adjacent surfaces of, for example, the plunger rod 1080 and the flange piece 1070 that generate a click sound when they come into contact with each other (such as the contact between the wing 1089 on the neck 1084 and the detent 1078 surrounding the opening 1073, as shown in FIGS. 3R - 3V). Such sounds may be used as an auditory feedback indicating to the user that a particular step in the use of the device 1050 has been reached.

[0088] In some embodiments, the device 1050 may include additional features or components for controlling the movement of the plunger rod 1080 relative to the body 1060. For example, as shown in FIG. 1F, the flange piece 1070 may include an opening 1079 through which the pin 1077 is disposed. The pin 1077 interfaces with (e.g., slides within an opening (not shown) in) the actuator portion 1082 of the plunger rod 1080 such that when the pin 1077 is inserted to engage the actuator portion 1082, the plunger rod 1080 does not move proximally or distally relative to the body 1060 and the flange piece 1070. In some embodiments, the pin 1077 may also prevent rotational movement of the plunger rod 1080 relative to the flange piece 1070. The pin 1077 may be inserted after filling and assembly of the device (e.g., the device 1050 shown in FIGS. 1A and 1B) to prevent unwanted movement of the plunger rod 1080 prior to its use. In some embodiments, the pin 1077 may remain inserted during packaging, transportation, and delivery of the device 1050. Prior to use of the device 1050, the pin 1077 may be removed or otherwise positioned so as not to engage the actuator portion 1082.

[0089] As shown in FIGS. 1G and 1H, in some embodiments, the protrusion 1093 may be disposed at the distal portion of the actuating portion 1082 that is located inside the flange piece 1070 after the assembly of the device 1050. The inner lip 1091 of the flange piece 1070 may protrude over the protrusion 1093 so that the actuating portion 1082 is not pulled proximally from the flange piece 1070. In some embodiments, either or both of the protrusion 1093 and the lip 1091 may be circumferentially disposed around the actuating portion 1082 such that the lip 1091 closes the protrusion 1093 regardless of the rotational position of the actuating portion 1082 relative to the flange piece 1070. The protrusion 1093 and the lip 1091 may have a square cross-sectional profile as shown in FIG. 1G, an angled cross-sectional profile as shown in FIG. 1H, or any other suitable cross-sectional profile. In some embodiments, the cross-sectional profile of either or both of the protrusion 1093 and the lip 1091 may be selected to improve the ease of manufacture (e.g., machining or molding the shape of the protrusion 1093 or the lip 1091), or may be selected to improve the assembly (e.g., insertion of the plunger rod 1080 into the flange piece 1070 and its parts).

[0090] As shown in FIG. 1I, in some embodiments, the actuating portion 1082 may include one or more protrusions 1096 that extend radially outward from the outer periphery of the protrusion 1093. For example, the protrusion 1093 may include a pair of protrusions 1096 that are disposed at positions opposite to each other around the protrusion 1093. The protrusions 1096 may include various suitable sizes, shapes, and / or cross-sectional profiles. In some embodiments, the protrusions 1096 may have a circular shape with a rounded outer profile that facilitates the movement of the protrusion 1093 within the flange piece 1070.

[0091] In this example, the protrusion 1096 may be disposed along the corresponding side surface of the actuating portion 1082 including the protrusion 1086 and the side surface of the protrusion 1093 aligned longitudinally. In other examples, the protrusion 1096 may be disposed along the side surface of the actuating portion 1093 including the protrusion 1086 and offset (e.g., not longitudinally aligned) from the side surface of the protrusion 1093. The protrusion 1096 may be formed of various flexible materials including polymers such as plastics, rubber, etc. It will be understood that the plunger rod 1080 may include more and / or fewer protrusions 1096 than those described and explained herein, without departing from the scope of the present disclosure, on the protrusion 1093 or other portions of the actuating portion 1082.

[0092] Figure 1J shows the distal end of a flange piece 1070 that includes one or more recesses 1097 along its inner surface. The recesses 1097 may be sized and shaped to receive a protrusion 1096 when a protrusion 1093 is received within the flange piece 1070 and is disposed adjacent to and in contact with or adjacent to or in contact with a lip 1091. The lip 1091 is configured to receive the protrusion 1096 and the protrusion 1093 within the distal end and within the flange piece 1070, thereby priming the device 1050 and applying fluid force to the plunger rod 1080 to prevent retraction (e.g., proximal movement) of the plunger rod 1080 relative to the flange piece 1070. It will be appreciated that the device 1050 may be configured to prevent removal of the plunger rod 1080 after initial assembly to the flange piece 1070, thereby preventing reuse of the device 1050 after initial use and preventing accidental air entrainment that would form air bubbles within the device 1050, or may be configured to prevent reuse of the device 1050 after initial use or prevent accidental air entrainment that would form air bubbles within the device 1050. In this example, the flange piece 1070 may include a plurality of recesses 1097 disposed in an annular arrangement relative to each other around the distal end. The plurality of recesses 1097 may be spaced apart from each other around the outer periphery of the flange piece 1070. In some embodiments, the flange piece 1070 may include recesses 1097 having various sizes and shapes or sizes or shapes relative to each other.

[0093] As will be described in further detail below, a subset of the plurality of recesses 1097 may be sized and shaped to receive the protrusion 1096 and allow passage therethrough after movement of the protrusion 1093 relative to the flange piece 1070. As will be described in further detail below, a second subset of the plurality of recesses 1097 may be sized and shaped to receive the protrusion 1096 and prevent passage therethrough such that further movement of the protrusion 1093 relative to the flange piece 1070 is restricted.

[0094] For example, as shown in FIG. 1K, the flange piece 1070 includes a pair of widened recesses 1097a disposed around an opening 1073 (through which the plunger rod 1080 is received) at positions opposite to each other (e.g., separated from each other by about 180 degrees). The flange piece 1070 further includes a pair of narrow recesses 1097b disposed around the opening 1073 at positions opposite to each other (e.g., about 180 degrees from each other). The recess 1097a may be disposed about 90 degrees away from the adjacent recess 1097b along the outer periphery of the flange piece 1070. The widened recess 1097a may include a lateral (e.g., perpendicular) central wall with respect to the longitudinal length of the flange 1076 and side walls angled with respect to the central wall. The narrow recess 1097b may include a central wall parallel to the longitudinal length of the flange 1076 and side walls perpendicular to the central wall. It will be understood that the widened recess 1097a may form a larger opening for receiving the protrusion 1096 with respect to the narrow recess 1097b. It will be further understood that the side walls of the recess 1097a and the recess 1097b may have a height parallel to the longitudinal length of the device 1050.

[0095] In the first configuration as seen in FIG. 1K, the plunger rod 1080 is received through the flange piece 1070, and the protrusion 1093 is oriented with respect to the opening 1073 such that the protrusion 1096 is received in the widened recess 1097a. The angled side walls of the widened recess 1097a may provide a gap to facilitate the movement of the protrusion 1096 out of the widened recess 1097a in response to the rotation of the plunger rod 1080 with respect to the flange piece 1070. In this example, the protrusion 1096 may move along the angled side walls of the widened recess 1097a when the protrusion 1093 rotates with respect to the opening 1073.

[0096] As shown in FIG. 1L, the protrusion 1096 may contact the inner surface of the flange piece 1070 that defines the opening 1073 when the protrusion 1093 rotates. The protrusion 1096 may cause frictional interference with the flange piece 1070 while moving between adjacent recesses 1097. FIG. 1M shows the protrusion 1093 arranged to be received in the narrow recess 1097b aligned with the protrusion 1096 with respect to the opening 1073. In this example, the plunger rod 1080 may be configured to generate both or either of acoustic feedback and tactile feedback in response to the receipt of the protrusion 1096 by the narrow recess 1097b. For example, a "click" or "snap" noise may be generated in response to the release of the pressure applied to the protrusion 1096 by the inner surface of the flange piece 1070 when the protrusion 1096 is received in the narrow recess 1097b. In addition and / or alternatively, the acoustic feedback may be generated in response to the protrusion 1096 expanding against and hitting one or more walls that define the narrow recess 1097b when the protrusion 1096 is received in the narrow recess 1097b.

[0097] It will be understood that the frictional interference between the protrusion 1096 and the flange piece 1070 may be removed after the protrusion 1096 is received within the narrow recess 1097b. The side walls of the narrow recess 1097b may provide a physical limitation that prevents further movement of the protrusion 1096. In this example, the plunger rod 1080 may be fixed to the flange piece 1070 such that when the protrusion 1096 is received within the narrow recess 1097b, the protrusion 1093 is inhibited from further rotation with respect to the opening 1073.

[0098] As shown in FIGS. 1N - 1P, in some embodiments, the plunger rod 1080 may, in addition to or instead of this, include a protrusion 1085 on the stem 1081 configured to interact with the opening 1073 of the flange piece 1070 such that it can only move distally through the opening 1073. The side surface 1092 of the opening 1073 may be angled to allow distal passage of the protrusion 1085 and prevent proximal passage of the protrusion 1085 when the stem 1081 moves through the opening 1073. Both or either of the protrusion 1085 and the side surface 1092 may have any suitable shape or configuration for achieving this purpose. In some embodiments, the shape or configuration of both or either of the protrusion 1085 and the side surface 1092 may be selected to improve the ease of manufacture (e.g., machining or forming the shape of both or either of the protrusion 1085 and the flange piece 1070).

[0099] In other embodiments, the flange piece 1070 may include a movable lever 1071a as seen in FIGS. 1Q - 1T. The movable lever 1071a may include a first end 1071b extending outwardly from the collar 1072 and a second end 1071c disposed within the collar 1072. The movable lever 1071a may be movable (e.g., rotatable) about a pivot pin 1071d. The second end 1071c may be disposed within the opening 1073 such that the movable lever 1071a is configured to interact with the protrusion 1085 after the plunger rod 1080 is received within the flange piece 1070. Referring initially to FIG. 1Q, the plunger rod 1080 may be configured to prime the device 1050 by translating the stem 1081 distally through the flange piece 1070 until it touches the movable lever 1071a.

[0100] As can be seen in FIG. 1R, the second end portion 1071c may abut against the protrusion 1085 when the movable lever 1071a is in the obstacle position. The second end portion 1071c may be configured to prevent the translation of the plunger rod 1080 relative to the flange piece 1070 when the plunger rod 1080 is in the primed position. It will be appreciated that the distance between the second end portion 1071c and the protrusion 1085 may define a priming distance for moving the plunger rod 1080 to prime the device 1050. The movable lever 1071a may be configured to move (e.g., pivot) about the rotation pin 1071d relative to the collar 1072 to move the second end portion 1071c from the obstacle position. The rotation axis along which the rotation pin 1071d extends may be substantially perpendicular to the longitudinal axis along which the plunger rod 1080 extends.

[0101] For example, as can be seen in FIG. 1S, the movable lever 1071a may be actuated in response to the distal movement of the first end portion 1071b about the rotation pin 1071d toward the flange 1076. In some embodiments, the first end portion 1071b may be actuated in response to, for example, a distal force applied to the first end portion 1071b by a user of the device 1050. The second end portion 1071c may be moved proximally relative to the rotation pin 1071d away from the flange 1076 in response to the distal movement of the first end portion 1071b, thereby disengaging the second end portion 1071c from the protrusion 1085.

[0102] Thus, as shown in FIG. 1T, the movable lever 1071a may allow the plunger rod 1080 to translate relative to the flange piece 1070 until the projection 1085 touches the junction point 1072a disposed at the distal end of the opening 1073. The junction point 1072a may settle the plunger rod 1080 at the administration completion position of the plunger rod 1080 when the projection 1085 engages the junction point 1072a. It will be appreciated that the distance between the second end portion 1071c and the junction point 1072a may define a dose delivery distance for moving the plunger rod 1080 to dispense a controlled volume of material from the device 1050.

[0103] As shown in FIGS. 1U and 1V, in some embodiments, the actuating portion 1082 of the plunger rod 1080 may include one or more extensions 1087 configured to interface with the side openings 1094, 1095 in the collar 1072 of the flange piece 1070, in addition to or instead of this. The extensions 1087 may extend distally from the actuating portion 1082 and may have angled or rounded distal portions sized and configured to be pushed inwardly toward the central axis of the plunger rod 1080 when the actuating portion 1082 is pushed distally into the collar 1072. The angled or rounded distal portion of each extension 1087 may include a hook or clip-shaped portion 1087a. The extensions 1087 may further be made of a flexible material that allows the extensions 1087 to be pushed into the collar 1072 and to bounce outwardly when no longer restricted by the sides of the collar 1072. The side openings 1094, 1095 in the collar 1072 are sized and configured to receive the hook or clip-shaped portion 1087a of the extension 1087 such that when the extension 1087 reaches the side opening 1094 or 1095, the hook or clip-shaped portion 1087a bounces outwardly into the side opening 1094 or 1095 and then prevents proximal movement of the plunger rod 1080. Some of the extensions 1087 may simultaneously occupy some of each of the side openings 1094 and 1095 such that each extension 1087 is received in the corresponding side opening 1094 or 1095 at the same time the plunger rod 1080 moves distally relative to the flange piece 1070.

[0104] In particular, the first side opening 1094 may be configured to receive the hook or clip-shaped portion 1087a of the extension 1087 after assembly of the device 1050 so as to prevent the plunger rod 1080 from moving proximally when the plunger rod 1080 is inserted into the ready-to-use position. When the hook or clip-shaped portion 1087a of each extension 1087 is received within the first side opening 1094, it may make a "click" sound as it interfaces with the collar 1072, thereby providing either or both auditory feedback and tactile feedback indicating that the device is in the ready-to-use position. In some embodiments, the first side opening 1094 may extend around a partial outer circumference of the collar 1072 such that the hook or clip-shaped portion 1087a of the extension 1087 may be received within the side opening 1094 at a series of rotational positions of the plunger rod 1080 relative to the flange piece 1070. The second side opening 1095 may be configured to receive the hook or clip-shaped portion 1087a of the extension 1087 when the device 1050 is in the "delivery" configuration (e.g., after priming and further rotating the actuator 1082 to align the protrusion 1086 and the slot 1074). In the embodiments shown in FIGS. 1U and 1V, the extension 1087 is longitudinally aligned with the protrusion 1086, and as shown in FIGS. 3C-3F, the side opening 1095 is similarly longitudinally aligned with the slot 1074, allowing further distal movement of the actuator 1082 into the collar 1072 when the device is in the "delivery" configuration. It will be understood that the device may be transitioned to the "delivery" configuration in response to applying a distal force to the actuator 1082 to disengage the engagement between the side opening 1094 and the extension 1087 and a rotational force sufficient to overcome the frictional force between the interior of the collar 1072 and the extension 1087. However, in other embodiments, it is contemplated that the extension 1087 and the side openings 1094, 1095 may be any suitable complementary configuration that serves to control the proximal movement of the plunger rod 1080.

[0105] In other embodiments, as shown in FIG. 1W, the side opening 1094 may be arranged longitudinally aligned with the side opening 1095 along the collar 1072. The device 1050 may be primed after receiving the hook or clip-shaped portion 1087a of the extension 1087 within the side opening 1094, which was initially disposed proximal to the side opening 1094. In some examples, feedback (e.g., tactile feedback, auditory feedback, etc.) may be generated in response to the reception of the extension 1087 within the side opening 1094. It will be appreciated that the proximal end of the collar 1072 may resist the distal advancement of the plunger rod 1080 relative to the flange piece 1070 in response to the engagement of the hook or clip-shaped portion 1087a with the collar 1072 at the side opening 1094. By applying a distal force to the plunger rod 1080, the extension 1087 may be released from the side opening 1094 and translated distally through the collar 1072 until received within the side opening 1095.

[0106] It will be appreciated that the distal force required to deflect the extension 1087 inwardly to release the hook or clip-shaped portion 1087a from the side opening 1094 may correspond to minimal priming and fluid forces. Thus, the plunger rod 1080 may be maintained in a constant radial orientation during the priming and delivery steps of the device 1050. In other embodiments, more and / or fewer side openings may be included along the circumferential wall of the collar 1072, longitudinally aligned and / or offset (e.g., not longitudinally aligned) with the side openings 1094, 1095.

[0107] As seen in FIG. 1X, the flange piece 1070 may include one or more inner protrusions 1095' instead of the side opening 1095 shown and described above. In this example, the plunger rod 1080 may be pre-assembled within the flange piece 1070 by pushing the extension 1087 (FIG. 1V) into the collar 1072 and positioning it relatively proximal to the side opening 1094. The device 1050 may be primed by pushing the plunger rod 1080 distally through the flange piece 1070 until the extension 1087 is received within the side opening 1094. In some examples, feedback (e.g., tactile, audible, etc.) may be generated in response to the receipt of the extension 1087 into the side opening 1095. In a further embodiment, the side opening 1094 may be flared and the extension 1087 may have a distal-tapering profile, or the side opening 1094 may be flared or the extension 1087 may have a distal-tapering profile, to facilitate further distal advancement of the plunger rod 1080 from the primed position to the administration-completed position.

[0108] Further translation of the plunger rod 1080 relative to the flange piece 1070 may cause the extension portions 1087 to bend radially inwardly towards each other, thereby enabling the plunger rod 1080 to be translated distally to deliver a dose from the device 1050. The plunger rod 1080 may continue to translate distally relative to the collar 1072 until the hook or clip-shaped portion 1087a (FIG. 1V) touches the inner protrusion 1095'. The inner protrusion 1095' may be configured to contact the extension portion 1087 to fix the plunger rod 1080 in the administration completed position and prevent further distal movement of the plunger rod 1080 relative to the flange piece 1070, or may be configured to fix the plunger rod 1080 in the administration completed position or prevent further distal movement of the plunger rod 1080 relative to the flange piece 1070. Thus, further movement of the plunger rod 1080 relative to the flange piece 1070 (e.g., both or either proximal and distal movement) may be prevented by the inner protrusion 1095' that engages the hook or clip-shaped portion 1087a within the collar 1072. The inner protrusion 1095' may include a size and shape or a complementary hook or clip-shaped portion that interacts with the hook or clip-shaped portion 1087a or the extension portion 1087. It will be understood that the distance between the side opening 1094 and the inner protrusion 1095' may define a dose delivery distance for dispensing a controlled volume of material from the device 1050.

[0109] In other embodiments, as shown in FIGS. 2A-2C, the flange piece 1070 may include a fixed sleeve 1072P that extends proximally from the collar 1072. The fixed sleeve 1072P may have a circular cross-section that defines an internal channel having openings at each end of the fixed sleeve 1072P. The internal channel of the fixed sleeve 1072P may extend through the longitudinal length of the fixed sleeve 1072P and may be longitudinally aligned with the opening 1073 (FIG. 1O) such that the longitudinal axes of the internal channel and the opening 1073 are coaxial with each other. The fixed sleeve 1072P may be sized, shaped, and configured to receive the stem 1081. In some embodiments the fixed sleeve 1072P may be integral with the collar 1072 while in other embodiments the fixed sleeve 1072P may be a separate component assembled onto the flange piece 1070.

[0110] The fixed sleeve 1072P may include a plurality of openings sized and shaped to receive the protrusions 1085. For example, the fixed sleeve 1072P may include a pair of proximal openings 1072Q and a pair of distal openings 1072R that are longitudinally spaced apart from each other by an offset distance. Further, the pair of proximal openings 1072Q are located at the same longitudinal position relative to each other, and the pair of distal openings 1072R are located at the same longitudinal position relative to each other. As will be described in more detail below, the longitudinal offset between the proximal openings 1072Q and the distal openings 1072R may define a dose delivery distance for moving the plunger rod 1080 to dispense a substance of a controlled volume from the device 1050. Alternatively, the longitudinal offset between the openings 1072Q and the openings 1072R may define a priming distance of the device 1050 such that the protrusion 1085 can first be received within the proximal opening 1072Q during assembly of the device 1050 to prevent proximal retraction of the plunger rod 1080. In this example, the dose delivery distance may correspond to the longitudinal offset between the distal end of the actuator 1082 and the bottom surface of the collar 1072 when the protrusion 1085 is received within the distal opening 1072R. Although not shown, it will be understood that a set of openings may be included on the fixed sleeve 1072P (e.g., proximal to the proximal opening 1072Q, distal to the proximal opening 1072Q, and / or distal to the distal opening 1072R) to further define both or either of the priming distance and the dose delivery distance.

[0111] The proximal end of the fixed sleeve 1072P may include an angled interface 1071P that defines the proximal opening of the fixed sleeve 1072P. The angled interface 1071P may taper radially inwardly toward the inner channel of the fixed sleeve 1072P and may be configured to direct the stem 1081 and the protrusion 1085 into the inner channel. In this example, the protrusion 1085 may extend in a side direction radially outward from the stem 1081 such that, in response to a force being applied to the protrusion 1085, the protrusion 1085 is configured to retract or deform radially inwardly into and / or toward the stem 1081, and may be pushable and formed of a flexible / deformable material, or may be pushable or formed of a flexible / deformable material. In other embodiments, the protrusion 1085 may be configured to at least partially deform the fixed sleeve 1072P to facilitate either or both of movement of the protrusion 1085 toward the openings 1072Q and 1072R and movement of the protrusion 1085 between the openings 1072Q and 1072R. In this example, the fixed sleeve 1072P may be formed of a flexible material that is bendable radially outward when a radial force is applied to the fixed sleeve 1072P by the protrusion 1085 when a distal force is applied to the stem 1081.

[0112] Continuing to refer to FIG. 2A, the fixed sleeve 1072P may be configured to receive the plunger rod 1080 through an internal channel and allow the stem 1081 to pass through the collar 1072 for priming the device 1050. The protrusion 1085 may be received within the fixed sleeve 1072P as the angled surface 1071P is contacted and pushed radially inward against the stem 1081 until the plunger rod 1080 has moved sufficiently distally such that the protrusion 1085 is received by the proximal opening 1072Q. As shown in FIG. 2B, the protrusion 1085 may be configured to expand radially outward (release the push) when aligned longitudinally with the proximal opening 1072Q to lock the stem 1081 relative to the flange piece 1070. In this example, the device 1050 may be in a primed position such that further distal translation of the stem 1081 relative to the fixed sleeve 1072P and the flange piece 1070 may deliver a dose from the device 1050. Alternatively, the device 1050 may be pre-assembled with the protrusion 1085 received within the proximal opening 1072Q such that distal translation of the stem 1081 relative to the fixed sleeve 1072P may prime the device 1050 until the protrusion 1085 is received within the distal opening 1072R.

[0113] As seen in FIG. 2C, while the protrusion 1085 is disposed within the proximal opening 1072Q, applying a distal force to the stem 1081 may cause the protrusion 1085 to be pushed (or deformed) radially inwardly into the fixed sleeve 1072P, thereby allowing the stem 1081 to translate distally relative to the fixed sleeve 1072P. Alternatively, the protrusion 1085 may be manually pushed (or deformed) by applying a radially inward force through the proximal opening 1072Q. The protrusion 1085 may move distally through the internal channel of the fixed sleeve 1072P and may be received by the distal opening 1072R. As the stem 1081 translates distally relative to the collar 1072 and the protrusion 1085 is received within the distal opening 1072R, the device 1050 may transition from the primed position to the administration complete position, thereby delivering a dose.

[0114] It will be appreciated that the volume of the dose delivered by the device 1050 may be controlled based on the longitudinal offset distance between the proximal opening 1072Q and the distal opening 1072R. In some embodiments, the fixed sleeve 1072P may include an additional opening for receiving the protrusion 1085 after priming and volume delivery to prevent proximal retraction of the stem 1081 relative to the flange piece 1070 (e.g., pulling back of the plunger rod 1080). For example, the distal opening 1072R may define the priming position, and a third set of openings (not shown) distal to the distal opening 1072R may define the dose delivery position such that the protrusion 1085 may be received within the proximal opening 1072Q during assembly of the device 1050 at the manufacturing stage. Alternatively, the inner surface of the bottom of the flange piece 1070 distal to the distal opening 1072R may define the dose delivery position of the plunger rod 1080.

[0115] In some embodiments, as seen in FIGS. 2D - 2G, the flange piece 1070 may include a movable sleeve 1072S that extends distally and proximally of the collar 1072. The movable sleeve 1072S may have a circular cross-section that defines an internal channel at an opening at each end of the movable sleeve 1072S. The internal channel of the movable sleeve 1072S may extend through the longitudinal length of the movable sleeve 1072S. The movable sleeve 1072S may be sized, shaped, and configured to be received through the opening 1073, and the internal channel of the movable sleeve 1072S may be sized to receive the stem 1081. The movable sleeve 1072S may be fixed relative to the collar 1072 in the assembled configuration and may be movable relative to the collar 1072 after engagement with the plunger rod 1080.

[0116] The movable sleeve 1072S may include a plurality of openings sized and shaped to receive the protrusions 1085. For example, the movable sleeve 1072S may include a proximal opening 1072U at the proximal end of the movable sleeve 1072S and a distal opening 1072T at the distal end of the movable sleeve 1072S. The proximal end of the movable sleeve 1072S may further include an angled interface 1071S that defines the proximal opening of the movable sleeve 1072S. The angled interface 1071S tapers radially inwardly towards the internal channel of the movable sleeve 1072S and may be configured to guide the stem 1081 and the protrusions 1085 into the internal channel of the movable sleeve 1072S. In some embodiments, the protrusions 1085 may extend radially outwardly in an opposite direction from the stem 1081 such that, in response to a force being applied to the protrusions 1085, the protrusions 1085 are configured to be pushed into and / or towards the stem 1081.

[0117] Continuing to refer to FIG. 2D, when in the assembled position, the proximal end of the movable sleeve 1072S may be disposed adjacent to the proximal end of the collar 1072, and the distal end of the movable sleeve 1072S may be disposed adjacent to the distal end of the collar 1072. The plunger rod 1080 may be received through an internal channel of the movable sleeve 1072S in which the stem 1081 extends through the collar 1072. The protrusion 1085 may be received within the distal opening 1072T such that the plunger rod 1080 is fixed to the movable sleeve 1072S. The protrusion 1085 may be configured to expand laterally outward out of the distal opening 1072T in response to the translation of the plunger rod 1080 relative to the movable sleeve 1072S.

[0118] For example, as shown in FIG. 2E, by applying a distal force to the actuator 1082, the protrusion 1085 may be pushed radially inward, thereby allowing the stem 1081 to translate distally relative to the movable sleeve 1072S. In this example, the protrusion 1085 may extend distally out of the distal opening 1072T and expand after translating distally from the distal end of the movable sleeve 1072S. The device 1050 may be transitioned from the assembled state to the primed state in response to the distal translation of the stem 1081 relative to the collar 1072 until the actuator 1082 abuts the proximal end of the movable sleeve 1072S. In this example, the device 1050 may be in the primed state, and further translation of the stem 1081 relative to the collar 1072 may be prevented by the presence of the movable sleeve 1072S.

[0119] Next, referring to FIG. 2F, the plunger rod 1080 may be coupled to the movable sleeve 1072S in response to proximal translation of the stem 1081 relative to the collar 1072 until the protrusion 1085 engages the proximal opening 1072U. It will be appreciated that the protrusion 1085 is in a depressed state when translating through the internal channel of the movable sleeve 1072S and may expand within the proximal opening 1072U after longitudinal alignment. By engaging the protrusion 1085 with the proximal opening 1072U and translating the plunger rod 1080 distally relative to the flange piece 1070, simultaneous movement of the movable sleeve 1072S relative to the collar 1072 may be provided. It will be appreciated that the overall length of the movable sleeve 1072S and the plunger rod 1080 may exceed the longitudinal length of the plunger rod 1080 alone.

[0120] As seen in FIG. 2G, the plunger rod 1080 may be configured to move the movable sleeve 1072S through the channel of the flange piece 1070 by a predetermined distance until the actuating portion 1082 touches the proximal end of the collar 1072. The plunger rod 1080 may be configured to deliver a dose from the device 1050 in response to distal translation of the movable sleeve 1072S relative to the collar 1072. It will be appreciated that the dose delivered by the device 1050 may be controlled based on a predetermined distance between the actuating portion 1082 and the collar 1072 when the protrusion 1085 is received within the proximal opening 1072U. In some embodiments, the flange piece 1070 may be configured to prevent proximal movement of the movable sleeve 1072S relative to the collar 1072 when the protrusion 1085 is received within the proximal opening 1072U. Although not shown, the flange piece 1070 may include one or more blocking components that can be used to limit proximal retraction of the movable sleeve 1072S from the opening 1073.

[0121] In other embodiments, as seen in FIGS. 2H - 2M, the plunger rod 1080 may include at least one protrusion 1085W disposed on the actuator portion 1082. In this example, the protrusion 1085W may be disposed at or adjacent to the distal end of the actuator portion 1082 such that the protrusion 1085W is received within the flange piece 1070 in response to the translation of the plunger rod 1080 into the collar 1072.

[0122] As seen in FIG. 2K, the flange piece 1070 may include one or more channels formed along the inner surface of the collar 1072. In particular, the collar 1072 may include a first (proximal) helical channel 1071W formed along the interior of the collar 1072 and having a first curvature, and a second (distal) helical channel 1072W formed along the interior of the collar 1072 that is different from and reverse to or different from or reverse to the first helical channel 1071W. For example, the first helical channel 1071W may be concave when viewed from the proximal end of the actuator portion 1082, while the second helical channel 1072W may be convex when viewed from the same viewing position. Alternatively, the first helical channel 1071W may be convex when viewed from the proximal end of the actuator portion 1082, while the second helical channel 1072W may be concave when viewed from the same viewing position. Further, the second helical channel 1072W may be longitudinally spaced from the first helical channel 1071W. The first helical channel 1071W may be connected to the second helical channel 1072W by a third channel 1073W that is an intermediate portion extending therebetween.

[0123] The third channel 1073W may extend along or substantially parallel to the longitudinal axis of the color 1072. It will be understood that the size, shape, and / or orientation of one or more channels on the color 1072 are merely exemplary and that other suitable configurations may be included without departing from the scope of the present disclosure. As will be described in detail below, the plurality of channels 1072 are configured to receive the protrusion 1085W. In some embodiments, the first helical channel 1071W and the second helical channel 1072W may be threaded and configured to engage corresponding components of the plunger rod 1080 (such as the protrusion 1085W). Opposite rotational movement may be required for the protrusion 1085W to pass through the first helical channel 1071W and the second helical channel 1072W. For example, a first rotational movement (e.g., clockwise) of the actuating portion may cause the protrusion 1085W to pass through the first helical channel 1071W, while the opposite rotational movement (e.g., counterclockwise) may cause the protrusion 1085W to pass through the second helical channel 1072W.

[0124] Referring to FIG. 2H, when the plunger rod 1080 is in the ready position, the projection 1085W may be received within the collar 1072 in response to distal translation of the actuating portion 1082 toward the flange piece 1070. As seen in FIG. 2I, the projection 1085W may be received within the first helical channel 1071W and move through the first helical channel 1071W in response to rotation of the plunger rod 1080 relative to the flange piece 1070 (e.g., in a first direction). It will be appreciated that the plunger rod 1080 may be configured to axially translate distally relative to the flange piece 1070 due to the curvature of the first helical channel 1071W as the plunger rod 1080 rotates within the collar 1072. For example, the plunger rod 1080 may translate a first distance defined by the configuration of the first helical channel 1071W until it reaches the end of the first helical channel 1071W. The first distance may correspond to a priming step of the device 1050 such that the device 1050 is at least partially primed after the projection 1085W has moved through the first helical channel 1071W.

[0125] Next, referring to FIG. 2J, the projection 1085W may be disposed at the end of the first helical channel 1071W and at the proximal (e.g., upper) end of the third channel 1073W. In some embodiments, the plunger rod 1080 may experience a haptic feedback formed by the end of the first helical channel 1071W. The plunger rod 1080 may be translated distally through the third channel 1073W to complete a priming step of the device 1050, as shown in FIG. 2K. It will be appreciated that the first helical channel 1071W and the third channel 1073W may collectively define a priming distance of the device 1050 such that the plunger rod 1080 reaches the primed position when the projection 1085W translates through the third channel 1073W.

[0126] The plunger rod 1080 may receive the protrusion 1085W within the second helical channel 1072W and be rotated in a second direction (opposite the first direction) to translate the plunger rod 1080 distally by a second distance defined by the configuration of the second helical channel 1072W. The second distance may be shorter than, longer than, and / or substantially equal to the longitudinal dimension of the second helical channel 1072W, based on a particular application and need. The plunger rod 1080 may be rotated in the second direction and translated by the second distance until it reaches the end of the second helical channel 1072W to deliver a dose from the device 1050. It will be understood that the second distance may correspond to the dose delivery step of the device 1050 such that after the protrusion 1085W has traveled through the second helical channel 1072W and reached the administration completion position, the device 1050 delivers the dose.

[0127] In other embodiments, as seen in FIGS. 2L - 2O, the plunger rod 1080 may include a protrusion, knob, and / or screw 1085X disposed on the actuator portion 1082. In this example, the screw 1085X may be disposed around the outer circumference along the distal end of the actuator portion 1082 such that the screw 1085X is received within the flange piece 1070 in response to the translation of the plunger rod 1080 into the collar 1072.

[0128] The flange piece 1070 may further include a threaded portion 1072X that forms a helical path configured to receive the screw 1085X within the opening 1073. In this example, the threaded portion 1072X may be disposed along the proximal portion of the opening 1073 such that the distal portion of the opening 1073 includes an unthreaded portion 1071X. As will be described in more detail herein, the threaded portion 1072X may define a longitudinal distance corresponding to the priming step of the device 1050, and the unthreaded portion 1071X may define a distance corresponding to the dose delivery step of the device 1050.

[0129] For example, as shown in FIG. 2L, the actuating portion 1082 may be translated distally toward the flange piece 1070 until the screw 1085X touches the distal end of the collar 1072. The rotation of the plunger rod 1080 in a first direction (e.g., clockwise or counterclockwise) may engage the screw 1085X with the threaded portion 1072X. As shown in FIG. 2M, the rotation of the plunger rod 1080 may provide an axial / longitudinal translation of the actuating portion 1082 into the collar 1072 as the screw 1085X moves through the helical path of the threaded portion 1072X. It will be understood that the device 1050 may be shifted from the ready position (FIG. 2L) to the primed position (FIG. 2N) by the rotation and translation of the screw 1085X through the threaded portion 1072X. By disengaging the screw 1085X from the threaded portion 1072X and positioning it along the non-threaded portion 1071X, the device 1050 may be in the primed position. In some examples, feedback (e.g., tactile, auditory, etc.) may be generated in response to the screw 1085W coming out of the threaded portion 1072X and / or the screw 1085W entering the non-threaded portion 1071X.

[0130] In this example, as shown in FIG. 2O, the actuating portion 1082 may be translated distally relative to the flange piece 1070 to deliver a dose from the device 1050 by applying a distal force to the actuating portion 1082. The screw 1085X may be moved through the distal portion of the opening 1073 when the screw 1085X is disposed within the non-threaded portion 1071X. The longitudinal length of the non-threaded portion 1071X defined between the distal end of the threaded portion 1072X and the distal end of the opening 1073 may control the dose delivery of the device 1050. The device 1050 may complete the volume delivery when the actuating portion 1082, which engages the distal surface facing proximally of the collar 1072 and the plunger rod 1080, reaches the administration complete position.

[0131] Figures 2P - 2T show further embodiments of flange pieces that may be configured and used similarly to the flange piece 1070 shown and described above, except for the differences specified in this specification. Similar reference numerals are used to represent similar components, and it will be understood that the flange pieces described below can be readily incorporated into one or more components of the apparatus 1050 shown and described above.

[0132] For example, first referring to FIG. 2P, the flange piece 1070A may include one or more flanges 1076A sized and configured to assist the user when holding the apparatus 1050 and discharging the formulated drug substance from the apparatus 1050, or when holding or discharging the formulated drug substance from the apparatus 1050. The flange 1076A may further be sized and shaped, or sized or shaped, to enable the user to hold the apparatus 1050 in a plurality of hand / grip positions, arrangements, and / or orientations. By way of example, the flange 1076A may be sized and shaped, or sized or shaped, such that the flange piece 1070A is held in a manner similar to a writing instrument (e.g., a pencil, pen, etc.) (not requiring the use of the flange 1076A), or may be sized as shown in FIG. 24A such that the flange 1076A abuts one or more fingers of the user. The flange piece 1070A may include a pair of flanges 1076A that extend radially outward from the collar 1072 in opposite radial directions. The flange 1076A may extend laterally from the collar 1072 (e.g., the flange 1076A may include an angled surface that slopes distally radially inwardly) and may be configured to prevent the user's finger from slipping off the flange piece 1070A during use of the apparatus 1050.

[0133] The flange 1076A may be interconnected to form a semi-circular profile having a minimum radius relative to the collar 1072. Thus, the flange 1076A may form a thin profile to facilitate visualization of a target treatment site (not shown) at the distal end of the device 1050 when using the device 1050 from the proximal side of the field of view of the finger flange 1070A. It will be understood that the finger flange 1070A may include other amounts and arrangements or amounts or arrangements of the flange 1070A different from those described and illustrated herein without departing from the scope of the present disclosure. In other embodiments, the flange 1076 may include various other suitable sizes and shapes or sizes or shapes.

[0134] The finger flange 1070A may further include a distal collar 1075A that extends distally from the collar 1072 and is configured to engage the body 1060 to hold the finger flange 1070A in a fixed position relative to the body 1060. The distal collar 1075A may be adhered, molded, or otherwise fixed to the body 1060, or may engage the body 1060 by a friction fit. In this example, the distal collar 1075A includes a longitudinal length that is generally shorter than the longitudinal length of the collar 1072. In some embodiments, the distal collar 1075A may be sized small enough to facilitate grasping and manipulation by the user during use of the device 1050 or to facilitate proper exposure of the body 1060 for grasping or manipulation. Further, the distal collar 1075A may include a material composition similar and different or similar or different from the collar 1072. For example, the distal collar 1075A may be formed of a flexible material configured to bend radially outward when the distal collar 1075A receives the body 1060 within the finger flange 1070A and to bend radially inward (without breaking the distal collar 1075A) to facilitate a snap-fit connection when the body 1060 is fully received. It will be understood that in other embodiments the finger flange 1070A may completely omit the distal collar 1075A.

[0135] In other embodiments, as seen in FIG. 2Q, the flange piece 1070B may include a distal collar 1075B that is substantially longer than the distal collars 1075, 1075A shown and described above. For example, the distal collar 1075B may be extended to a longitudinal length that exceeds the longitudinal length of the collar 1072. In this example, the distal collar 1075A may be sized large enough to include the substantial length of the body 1060. In this example, the outer surface of the distal collar 1075B may provide an interface for a user to grasp and manipulate during use of the device 1050 or to potentially grasp or manipulate. Further, the distal collar 1075B may include an extended diameter that exceeds the diameter of the body 1060 to provide an improved surface area for grasping the flange piece 1070B. In other words, the distal collar 1075B may have either or both of an enlarged size and an enlarged shape to enhance the gripping and manipulation or ease of gripping or manipulation of the device 1050. In this example, the distal collar 1075B may have a flare shape with a convex outer surface when viewed from the outside of the flange piece 1070B of the device.

[0136] Alternatively, as seen in FIG. 2R, the flange piece 1070C may include a distal collar 1075C that is substantially similar to the distal collar 1075B and includes a longitudinal length that exceeds the longitudinal length of the collar 1072. In this example, the outer surface of the distal collar 1075C provides an interface for the user to grasp and manipulate during use of the device 1050 or to potentially grasp or manipulate. The distal collar 1075C may include a thin profile having a diameter that exceeds the diameter of the body 1060 such that the distal collar 1075C does not substantially increase the profile of the body 1060. In other words, the distal collar 1075C may have a narrowed size compared to the distal collar 1075B. In some embodiments, the distal collar 1075C may include a terminal lip 1077C that extends radially outward at the distal end. The terminal lip 1077C may be sized, shaped, and configured to enhance the grasping and manipulation or the grasping or manipulation of the distal collar 1075C. In this example, the distal collar 1075C may have a flare shape with a concave outer surface when viewed from the outside of the flange piece 1070C of the device.

[0137] In other embodiments shown in FIGS. 2S - 2T, the flange piece 1070D may include a collar 1072D having a proximal lip 1074D. The proximal lip 1074D may define an irregular surface configured to interface with the plunger rod 1080 when the actuator 1082 is received by the collar 1072D. For example, the proximal lip 1074D may include a pair of concave surfaces 1075D disposed along opposing side surfaces along the proximal lip 1074D. In other words, the concave surfaces 1075D may be separated from each other by the surface and portions or surfaces or portions of the proximal lip 1074D that are not recessed. In this example, the concave surfaces 1075D may be disposed adjacent to the slot 1074 and may define a path for moving the plunger rod 1080 relative to the collar 1072D to prime the device 1050 and deliver a dose from the device 1050. In some embodiments, the concave surfaces 1075D may include a helical configuration (e.g., having an inclination in the distal direction) such that the concave surfaces 1075D taper in the distal direction between the first ledge 1073D and the second ledge 1076D.

[0138] In some embodiments, the flange piece 1070D may include a visualization mechanism, such as one or more labels or markings disposed on the collar 1072D, for example, to provide an indication to the user of the device 1050. For example, one or more labels (e.g., numbers) may indicate a direction for rotating or otherwise moving the plunger rod 1080 relative to the flange piece 1070D to prime the device 1050 and deliver a dose from the device 1050. By way of example, one or more labels may include markings indicating a starting position (e.g., "1"), a priming position (e.g., "2"), and a dose delivery position (e.g., "3") of the protrusion 1086 relative to the proximal lip 1074D. The one or more labels may be adhered, printed, embossed, and / or molded onto the collar 1072D.

[0139] As will be described in more detail herein, the flange piece 1070D may be configured to allow movement of the plunger rod 1080 in a single direction when priming the device 1050 to deliver a dose. In an exemplary use, the plunger rod 1080 (not shown) is first received through the flange piece 1070D, and the actuator 1082 may be positioned relative to the collar 1072D using a protrusion 1086 disposed along the first end of the concave surface 1075D on the opposite side of the slot 1074 at the marking "1". The protrusion 1086 may be rotated in a single direction only along the concave surface 1075D towards the marking "2" by a first ledge 1073D that prevents the protrusion 1086 from moving away from the marking "2" and in the opposite direction.

[0140] When the protrusion 1086 is received along the concave surface 1075D at the marking "2", the second ledge 1076D may further prevent the protrusion 1086 from moving past the slot 1074 and past the marking "3". The configuration of the proximal lip 1074D is exemplary, and it will be understood that the flange piece 1070D may include various other sizes, shapes, and / or configurations of both or one of the proximal lip 1074D and the concave surface 1075D that are different from those described and illustrated herein to facilitate movement of the plunger rod 1080 during use of the device 1050.

[0141] In other embodiments, the components of device 1050 may include one or more color indicators instead of and / or in addition to the markings described above to provide an indication to the user of device 1050. For example, device 1050 may include a color, symbol (e.g., an arrow), etc. indicating the direction to rotate or otherwise move plunger rod 1080 relative to flange piece 1070D to prime and deliver a dose. In one embodiment, the outer surface of plunger rod 1080 may have different colors along various portions of actuator 1082 to indicate the respective starting position (e.g., green), priming position (e.g., yellow), and dose delivery position (e.g., red) of plunger rod 1080 relative to color 1072D. One or more color indicators may be printed or molded onto plunger rod 1080. In other embodiments, various portions of plunger rod 1080 may include various textures instead of and / or in addition to the color indicators described above to provide an indication to the user of device 1050.

[0142] The components of device 1050 may be made of any suitable material, and each component may be manufactured from the same or different materials than other components. In some embodiments, it will be understood that one or more components of device 1050 (such as flange piece 1070, proximal collar 1072, plunger rod 1080, actuator 1082, etc.) may be formed of a flexible material having sufficient flexibility to prevent breakage during flexion. In some embodiments, one or more components of device 1050 may be hard and have sufficient strength to maintain shape and provide support. In other embodiments, one or more components of device 1050 (or at least a portion of a component) may have varying rigidity along its longitudinal length or transverse width such that the component has varying flexibility. In yet another embodiment, one or more components of device 1050 may have sufficient rigidity and strength to maintain shape and provide support while also having sufficient flexibility to prevent breakage during flexion. In some embodiments, such features may also provide feedback (such as tactile, sound, visual, etc.) to the user when bending and interacting with other components of device 1050 or when bending or interacting with the component itself. For example, each of body 1060, flange piece 1070, and plunger rod 1080 may be made of a material including a polymer such as plastic. In some embodiments, one or more of body 1060, flange piece 1070, and plunger rod 1080 may include a plurality of different materials (such as glass, rubber, and / or plastic). In some embodiments, for example, the cylindrical portion of body 1060 may be made of glass, Plexiglas, or any other suitable polymer (such as cyclic olefin polymer or cyclic olefin copolymer) or other material, and stopper 1062 may be made of, for example, plastic, rubber, or other polymer or copolymer.In a further example, the flange piece 1070 may include a polypropylene homopolymer, an ABS (Acrylonitrile, Butadiene, and Styrene) polymer, an ABS polycarbonate blend, and other suitable materials. In some embodiments, the plunger rod 1080 may include an ABS polycarbonate blend. These materials may provide higher tolerances for the manufacture (e.g., injection molding) of both or either of the flange piece 1070 and the plunger rod 1080, or may facilitate enhancing the reproducibility of the above components of the device 1050. As described in more detail above, in some embodiments, one or more components of the device 1050 may be formed of a flexible and deformable or flexible or deformable material composition that provides higher tolerances (e.g., without breaking) against bending or deformation of the above components when priming the device 1050 or delivering a dose from the device 1050.

[0143] In some embodiments, a portion of the body 1060 configured to contain the formulated drug substance may be made of a transparent or translucent material. In some embodiments, the flange piece 1070 and the plunger rod 1080 may be made of the same, similar, or different materials, such as the same or different plastics (e.g., each having the same or different hardness). In some embodiments, the components of the device 1050 may include an elastic material. For example, the components of the device 1050 may include rubber or plastic configured to enable a user to better grip the device 1050 or to provide an airtight or otherwise sealed fit between two components of the device 1050 (e.g., between the body 1060 and the stopper 1062). In some embodiments, a portion or all of the plunger rod 1080 (e.g., both or one of the actuating portion 1082 and the extension portion 1087, or alternatively the entire plunger rod 1080) may be made of a material having a degree of flexibility, such as to enable bending of the extension portion 1087. One or more of the materials listed above (e.g., plastic, rubber, polymer, or copolymer) may have such properties. In some embodiments, a portion or all of the device 1050 may be suitable for sterilization, such as by heat sterilization or chemical sterilization.

[0144] Figures 2A and 2B illustrate an exemplary method of assembling the delivery device shown in Figures 1A-1E. The flange piece 1070 may be assembled to the body 1060 as shown in Figure 2A. Assembly of the flange piece 1070 to the body 1080 may include sliding, snap connecting, attaching, or otherwise bonding the two components. As shown in Figure 2A, the flange piece 1070 may be slid onto the body 1060 such that, for example, the lip 1071 of the flange piece 1070 engages the body flange 1061. The plunger rod 1080 may be inserted through the assembled flange piece 1070 and body 1060 such that the distal end of the plunger rod 1080 contacts the stopper 1062. The assembled device 1050 may then be configured for packaging, sterilization, and / or use.

[0145] Figures 3C - 3F illustrate an exemplary method of assembling apparatus 1050 where the actuating portion 1082 includes the extension portion 1087 and the collar 1072 includes the side opening 1094. In such an embodiment, the plunger rod 1080 may be inserted through the flange piece 1070 until received within the side opening 1094, at which point the assembled apparatus 1050 may be in a configuration suitable for packaging, sterilization, and / or use. It will be understood that when the hook or clip portion of the extension portion 1087 is received within the side opening 1094, the side opening 1094 may be configured to prevent proximal retraction of the plunger rod 1080 relative to the flange piece 1070. The side opening 1094 may function as a first lock to prevent disassembly of the apparatus 1050 when the apparatus 1050 is in its initial assembled state.

[0146] As described in further detail herein (see Figures 4G - 4J), the side opening 1095 may be configured to prevent proximal retraction of the plunger rod 1080 when the hook or clip portion of the extension portion 1087 is received therein. The side opening 1095 may function as a second lock when the apparatus 1050 is in a dosage delivery state to prevent extraction of the patient's body fluid after completion of drug / medicine delivery. It will be understood that the side openings 1094, 1095 may generate feedback indicating the relative position of the plunger rod 1080 relative to the flange piece 1070, such as acoustic feedback, tactile feedback, etc. In some embodiments, the apparatus 1050 may include more and / or fewer side openings 1094, 1095 than those described and illustrated herein to increase and / or decrease the amount of locking on the apparatus 1050.

[0147] In some embodiments, the assembly of the device 1050 may include pre-filling the body 1060 before combining the body 1060 with the flange piece 1070 and the stopper 1080. For example, a predetermined amount of the active ingredient may be disposed within the body 1060 between the stopper 1062 and the needle tip 1064. In some embodiments, an alternative order of assembly of the components of the device 1050 may be used based on the variations contemplated in the structure of the components of the device 1050. For example, in one embodiment (not shown) configured such that the flange piece 1070 is assembled to the body 1060 using a snap-fit interface, the plunger rod 1080 may first be inserted through the flange piece 1070, and the combination of the flange piece 1070 and the plunger rod 1080 may be assembled to the body 1060 such that, for example, the flange piece 1070 is snapped onto the proximal body flange 1061 of the body 1060 to insert the plunger rod 1080 into the body 1060.

[0148] Figures 4A - 4F illustrate an exemplary method of using the device 1050 according to aspects of the present disclosure. In the pre - use configuration shown in Figure 4A, the device 1050 may hold an amount of the active pharmaceutical ingredient between the stopper 1062 and the discharge end 1064. There may be a priming distance p between the protrusion 1086 and the proximal end of the proximal collar 1072, and the protrusion 1086 may be misaligned with the slot 1074. In the priming step shown in Figure 4B, the plunger rod 1080 may be further longitudinally moved within the body 1060. For example, the user may partially push the actuator 1082 into the proximal collar 1072 of the flange piece 1070. In some embodiments, the device 1050 may be held in an inverted position during this step to ensure that the air trapped within the body 1060 is discharged through the discharge end 1064 as the stopper 1062 is pushed distally by the plunger rod 1080. During the pre - use configuration of Figure 4A and the priming step shown in Figure 4B, the plunger rod 1080 may be prevented from rotating about the longitudinal axis of the syringe by the geometry of the opening 1073 in the flange piece 1070 and the neck 1084 of the plunger rod 1080 (as shown in the horizontal cross - sectional view in Figure 4B). As shown in Figure 4C, the priming step may be stopped when the protrusion 1086 of the plunger rod 1080 abuts against the proximal end of the proximal collar 1072. When the priming step is complete, the neck 1084 of the plunger rod 1080 may be longitudinally aligned with the opening 1073 of the flange piece 1070 such that it is now rotatable relative to the flange piece 1070. For example, when the priming step is complete, the narrower portion of the neck 1084 may be disposed inside the opening 1073 as compared to when the device was in the pre - use configuration.

[0149] As shown in FIG. 4D, the device 1050 may be in a priming configuration. In the dispensing preparation step shown in FIG. 4E, the plunger rod 1080 may be rotated about its longitudinal axis to align the protrusion 1086 with the slot 1074. To do so, the user may grasp and twist the actuating portion 1082. In some embodiments, as described elsewhere herein, the actuating portion 1082 can be twisted in either direction to align the protrusion 1086 with the slot 1074. In other embodiments, the actuating portion 1082 may be rotatable in only one direction. In some embodiments, when the protrusion 1086 aligns with the slot 1074, further rotation of the plunger rod 1080 relative to the flange piece 1070 may be stopped, for example, by contact between the geometry of the neck 1084 and the opening 1073. Thus, alignment of the protrusion 1086 with the slot 1075 may lock the device 1050 in a dispensing-ready configuration. In some embodiments, rotation of the actuating portion 1082 may align the protrusion 1086 with the slot 1074, and the plunger rod 1080 may remain stationary longitudinally relative to the flange piece 1070 (e.g., rotation of the actuating portion 1082 does not cause proximal or distal movement of the plunger rod 1080). As shown in FIG. 4F, in the dispensing step, the plunger rod 1080 may be further moved longitudinally within the body 1060. For example, the user may push the distal actuating portion 1082 into the proximal collar 1072 of the flange piece 1070 such that the protrusion 1086 slides within the slot 1074. When the protrusion 1086 abuts the distal end of the slot 1074, further distal movement of the plunger rod 1080 is stopped. The dispensing step may ensure that a predetermined volume of the drug substance is dispensed from the device 1050 into the interior of the body 1060. In some embodiments, when the protrusion 1086 abuts the distal end of the slot 1074, the stopper 1062 does not “bottom out” or contact the interior of the discharge end 1064 of the body 1060.Advantageously, by ensuring that a predetermined volume of the active ingredient is dispensed from the device 1050 into the interior of the body 1060 before the stopper 1062 can bottom out, any variations in the manufacture of the discharge end 1064 (e.g., changes in the exact size or shape of the discharge end 1064) are less likely to affect the predetermined volume of the active ingredient delivered from the device 1050. Indeed, in some embodiments, the predetermined volume of the active ingredient delivered from the device 1050 may not be affected by common variations in the manufacture of any component of the device 1050, particularly any component other than the flange piece 1070. Advantageously, this may allow for the presence of different or greater tolerances in the manufacturing variations (e.g., variations in the formation of the glass body 1060 or other glass components) in some components of the device 1050 without affecting the predetermined volume of the active ingredient to be delivered from the device 1050.

[0150] In some embodiments, after one or more steps in the use of device 1050, the user may be prevented from both or either re - executing the steps and reversing one or more steps. For example, due to the geometry of the neck 1084 of the plunger rod and the opening 1073, the user may be prevented from pulling the plunger rod 1080 proximally (e.g., outwards) of the body 1060, rotating the plunger rod 1080 prematurely (e.g., before the priming step shown in FIG. 4C), and / or over - rotating the plunger rod 1080 during the dispensing preparation step (e.g., as shown in FIG. 4E). In particular, FIGS. 4G - 4J show the steps in the use of an embodiment of device 1050 having an extension 1087 on the actuator 1082 and corresponding side openings 1094, 1095 in the collar 1072 of the flange piece 1070. FIGS. 4G and 4H show device 1050 with the actuator 1082 pushed distally into the collar 1072. By their angled distal portions, the extensions 1087 are pushed into the interior of the collar 1072. When the plunger rod 1080 is rotated to the "delivery" position and the actuator 1082 is further pushed distally into the collar 1072 to deliver a predetermined volume of the drug substance from the device 1050, the extension 1087 may be received within the side opening 1095 (as shown in FIGS. 4I and 4J) to limit the subsequent proximal movement of the plunger rod 1080. Advantageously, by limiting the proximal movement of the plunger rod 1080, inadvertent withdrawal of material into the device 1050, for example from the site where the drug substance is delivered, may be prevented. In some embodiments, device 1050 may include side opening 1094 or side opening 1095. In other embodiments, as shown in FIGS. 4G - 4J, device 1050 may include both side opening 1094 and side opening 1095.

[0151] Figures 4K and 4O further show in more detail exemplary aspects of the geometry of the neck 1084 that can assist in controlling the movement of the plunger rod 1080. For example, the neck 1084 and the proximal portion a of the stem 1081 (shown in section d in FIG. 4K) may both have a first cross-sectional shape as shown in FIG. 4L. This shape may allow the corresponding portion of the plunger rod 1080 to move proximally / distally of the blocking component (e.g., the flange piece 1070) through an opening (e.g., the opening 1073), but may prevent rotation of the plunger rod 1080 about its longitudinal axis. The constricted portion b of the neck 1084 may have a smaller cross-sectional shape, as shown in FIG. 4M. This shape may allow for one-way or two-way rotation of the plunger rod 1080 about its longitudinal axis when disposed within the opening (e.g., the opening 1073) of the blocking component (e.g., the flange piece 1070). It will be understood that each portion (e.g., the constricted portion b) of the neck 1084 that allows for transitional rotation of the plunger rod 1080 may have a geometry with the smallest cross-sectional shape that allows for such movement relative to the cross-sectional shape of other portions of the plunger rod 1080. The third portion c of the neck 1084 may have a larger cross-sectional shape as shown in FIG. 4N that may directly correspond to the size and shape of the opening (e.g., the opening 1073) of the blocking component (e.g., the flange piece 1070). Thus, proximal or distal movement of this portion of the neck 1084 through the opening 1073 may be possible only when the plunger rod 1080 is in a particular rotational orientation with respect to the flange piece 1070. Further, the plunger rod 1080 is not rotatable while the portion c of the neck 1084 is disposed within the opening 1073. This may ensure, for example, that the plunger rod 1080 is in a desired position with respect to the flange piece 1070 (e.g., priming is complete and the portion c is no longer disposed within the opening 1073) before the plunger rod 1080 becomes rotatable.The cross-sectional shapes of the various necks 1084 and the size and shape of the opening 1073 may be combined together to create a specific sequence of movement of the plunger rod 1080 necessary to prime the device 1050 and deliver the active ingredient from the device 1050. In this example, the distal portion of the opening 1073 may have the largest cross-sectional profile with respect to either or both of the intermediate and proximal portions of the opening 1073 so as to correspond to the various geometric shapes (such as the neck 1084, the stem 1081, etc.) of the plunger rod 1080 passing through the distal portion.

[0152] In another embodiment shown in FIG. 4O, the proximal portion e of the neck 1084 and the majority portion h of the stem 1081 may both have a first cross-sectional shape as shown in FIG. 4P. This shape may allow the corresponding portion of the plunger rod 1080 to move proximally / distally through an opening (e.g., opening 1073) of a blocking component (e.g., flange piece 1070), but may prevent rotation of the plunger rod 1080 about its longitudinal axis. The constricted portion f of the neck 1084 may have a smaller winged (or arrow-shaped) cross-sectional shape as shown in FIG. 4Q (in the pre-rotation configuration with respect to the flange piece 1070) and FIG. 4R (in the post-rotation configuration with respect to the flange piece 1070). This “winged” shape may allow unidirectional or bidirectional rotation of the plunger rod 1080 about its longitudinal axis when disposed within an opening (e.g., opening 1073) of a blocking component (e.g., flange piece 1070), and may limit or resist “reverse” rotation of the plunger rod 1080 in the opposite direction after the rotation is complete (as further described with respect to FIGS. 4T - 4X). The portions g and l of the plunger rod 1080 may have a larger cross-sectional shape as shown in FIG. 4S, which may directly correspond to the size and shape of an opening (e.g., opening 1073) of a blocking component (e.g., flange piece 1070). Thus, proximal or distal movement of these portions of the plunger rod 1080 through the opening 1073 may be possible only when the plunger rod 1080 is in a particular rotational orientation with respect to the flange piece 1070. Further, the plunger rod 1080 may not be rotatable while the portion g or l of the plunger rod 1080 is disposed within the opening 1073. This may ensure that, at a particular step during assembly and use of the device 1050, for example, the plunger rod 1080 is in a desired position with respect to the flange piece 1070, enabling accurate assembly and use of the device 1050.Furthermore, except when in a specific rotational position relative to the flange piece 1070, portions g and l cannot move proximally through the opening 1073, so their "larger" cross-sectional area may be used to prevent "backing out" of the plunger rod. For example, after rotation of the plunger rod 1080 from a "priming" position to a "delivery" position, portion g of the plunger rod 1080 cannot move through the opening 1073, thereby preventing "backing out" of the plunger rod at that stage of use of the device 1050. Additionally, by combining the cross-sectional shapes of the various plunger rods 1080 with the size and shape of the opening 1073, a specific sequence of movement of the plunger rod 1080 may be created that is necessary to assemble, prime, and deliver the active ingredient from the device 1050.

[0153] Figures 4T-4X show in greater detail the particular interaction between the wing-shaped portion of the neck 1084 and the opening 1073 in the flange piece 1070. The flange piece 1070 may include a detent 1078 adjacent to or within the opening 1073 that interfaces with the wing 1089 on the neck 1084. FIG. 4T shows a cross-sectional view of the neck 1084 inside the opening 1073 in a pre-rotation configuration (e.g., after the device 1050 has been primed and before the plunger rod 1080 has been rotated to the “delivery” configuration relative to the flange piece 1070). FIG. 4U shows that as the plunger rod 1080 is rotated about the longitudinal axis, one of the wings 1089 may contact one of the detents 1078 (depending on the direction of rotation). As rotation continues, one of the detents 1078 may push one of the wings 1089 into the remainder of the neck 1084. When rotation is complete, one of the wings 1089 extends past one of the detents 1078. This extension of the wing 1089 past the detent 1078 provides both or either an audible “click” feedback and a tactile feedback indicating that rotation is complete, and may thereafter prevent “reverse” rotation of the plunger rod 1080 relative to the flange piece 1070. The wings 1089 and detents 1078 may interact in a similar manner regardless of whether the plunger rod 1080 is rotated clockwise or counterclockwise, thereby enabling bidirectional rotation of the plunger rod 1080 to move the plunger rod 1080 from the “priming” position to the “delivery” position. As shown in greater detail in FIG. 4X, each wing 1089 has a rounded shape that allows for ease of rotation in one direction, and the extension of the wing 1089 past the detent 1078 may position the wing 1089 such that it strongly resists or otherwise prevents rotation in the opposite direction relative to the detent 1078. The detent 1078 may have any suitable profile configured to assist the one-way movement of the wing 1089 past the detent 1078.

[0154] Advantageously, the various configurations of the plunger rod 1080 described herein may enable one-piece (e.g., plunger rod 1080) or two-piece (e.g., plunger rod 1080 and flange piece 1070) to be modeled, molded, and / or manufactured to achieve several goals, such as controlling the movement and assembly of the desired plunger rod, reducing user errors, preventing the backing out of the plunger rod, and minimizing several different parts that need to be manufactured and handled to assemble the device 1050.

[0155] In some embodiments, as seen in FIGS. 4Y - 4Z, the device 1050 may include a pair of plunger rods that are interchangeable with one actuator 1082 or coupled to separate actuators 1082 in one kit. For example, referring first to FIG. 4Y, the device 1050 may include a first plunger rod 1080A that is substantially similar to the plunger rod 1080 shown and described above, except for the differences specified herein. The first plunger rod 1080A may include a stem 1081A having a longitudinal length A defined between the distal end of the actuator 1082 and the tip 1083A. As will be described in detail below, the longitudinal length A may define a priming distance for moving the plunger rod 1080A relative to the flange piece 1070 to prime the device 1050. The tip 1083A may have a flat, planar, or flat or planar interface configured to prevent engagement with the stopper 1062 when the first plunger rod 1080A is received within the body 1060.

[0156] Next, referring to FIG. 4Z, the device 1050 may further include a second plunger rod 1080B that is substantially similar to the plunger rod 1080. The second plunger rod 1080B may include a stem 1081B that extends distally from the actuator 1082 and has a longitudinal length B defined between the distal end of the actuator 1082 and the tip 1083B. The tip 1083B is substantially similar to the tip 1083A described above. The longitudinal length B of the stem 1083B is relatively longer than the longitudinal length A of the stem 1081A and may define a dosage delivery distance for moving the plunger rod 1080A relative to the flange piece 1070 to deliver a dosage from the device 1050.

[0157] The first plunger rod 1080A may be configured to prime the device 1050 in response to translation of the stem 1081A into the body 1060 through the collar 1072 (see FIGS. 1A-1B). In this example, the tip 1083A may contact the stopper 1062 and push the stopper 1062 distally by a priming distance. It will be understood that the priming distance of the device 1050 may be controlled based on the size of the longitudinal length A of the first plunger rod 1080A. After priming of the device 1050, the first plunger rod 1080A may be removed from the body 1060 and the flange piece 1070 without the stopper 1062 being retracted by the flat interface of the tip 1083A. Thus, the stopper 1062 may remain in a fixed position relative to the body 1060 after the first plunger rod 1080A is retracted.

[0158] The second plunger rod 1080B may be configured to deliver a dose from the device 1050 in response to the translation of the stem 1081B into the body 1060 through the collar 1072 after the priming step using the stem 1081A (see FIGS. 1A-1B). In this example, the distal end 1083B may contact the stopper 1062 and push the stopper 1062 distally by the dose delivery distance. It will be appreciated that the dose delivery distance of the device 1050 may be controlled based on the size of the longitudinal length B of the second plunger rod 1080B. The dose delivery distance may be substantially equal to the difference in length between the stem 1081B and the stem 1081A.

[0159] FIGS. 5A-5C show another exemplary delivery device 1200 according to a further embodiment of the present disclosure. The device 1200 includes a body 1220 and a flange piece 1240 having a proximal collar 1242 in which an inner collar 1260 may be disposed. The proximal collar 1242 and the inner collar 1260 may together form a blocking component for the device 1200. The plunger rod 1280 may pass through the inner collar 1260 and the flange piece 1240 and into the body 1060. The plunger rod 1280 may have an operating portion 1282 that shares a longitudinal axis with the central axes of the proximal collar 1242 and the inner collar 1260 and is sized and configured to fit (e.g., nest or otherwise fit) within the inner collar 1260.

[0160] The device 1200 may be, for example, an injection device such as a syringe for dispensing a predetermined volume of a formulated active ingredient. In general, the device 1200 may share size, volume, material, preparation, assembly, manufacture, operation, or usage characteristics with the device 1050 or other delivery devices disclosed herein. Similar to the device 1050, the device 1200 may be configured to facilitate use and may include one or more features that assist the user by providing tactile, auditory, or visual feedback (e.g., using any of the features described elsewhere herein).

[0161] The body 1220 may have all or some of the same features as, for example, the body 1060 of the device 1050 or any syringe body known in the art. For example, in some embodiments, the body 1220 may be pre-fillable or pre-filled (e.g., capable of being filled with the active pharmaceutical ingredient before completion of assembly, packaging, sterilization, and / or shipment of the device 1200 to the user or filled with the active pharmaceutical ingredient). In some embodiments, the stopper 1222 may be configured to be inserted into the body 1220 and may be configured to hold a predetermined volume of the formulated active pharmaceutical ingredient inside the body 1200 between the stopper 1222 and the discharge end 1224.

[0162] The flange piece 1240 may be of any suitable size and shape or sizes or shapes for closing, partially closing, plugging, or partially plugging the end of the body 1220 opposite the discharge end 1224 and for supporting and holding the plunger rod 1280 in place inside the body 1220 or for any of these purposes. In some embodiments, the flange piece 1240 may share some characteristics with the flange piece 1070 of the device 1050. For example, the flange piece 1240 may include a distal collar 1244 configured to engage the body 1220 and hold the flange piece 1240 in place relative to the body 1220. For example, the distal collar 1244 may include a lip 1245 that slides over the body flange 1226 to hold the flange piece 1240 in place. In an alternative embodiment, the lip 1245 of the distal collar 1244 may be made of a flexible or semi-flexible material that snaps into place on the body flange 1226. In further embodiments, the distal collar 1244 or other portions of the flange piece 1240 may be affixed, molded, or otherwise secured to the body 1220 or may engage the body 1220 by friction fit.

[0163] In some embodiments, the flange piece 1240 may include one or more flanges 1246 sized and configured to assist the user in holding the device 1200 and discharging the formulated drug substance from the device 1200, or in holding the device 1200 or discharging the formulated drug substance from the device 1200. In some embodiments, as shown in FIGS. 1A-1E, the flange piece 1240 may include two flanges 1246 that face each other and extend perpendicular to the longitudinal dimension of the device 1200. In some embodiments, the flange piece 1240 may include other arrangements of one or more flanges, such as four flanges extending radially outward from the longitudinal central axis of the device 1200 or one circumferential flange. In some embodiments, the flange piece 1240 may extend radially outward from the longitudinal central axis of the device 1200 further away from the outer circumference of the body 1220. In such embodiments, the flange piece 1240 may support the device 1200 when the device 1200 is placed on a surface, may prevent the device 1200 from rolling on a plane, and / or may enable the device 1200 to be more easily picked up.

[0164] In some embodiments, the flange piece 1240 and the inner collar 1260 may be sized and configured to function as blocking components in the device 1200, for example, by restricting and directing or restricting and directing the rotation and axial movement of the plunger rod 1280. The proximal collar 1242 of the flange piece 1240 may be sized and configured to receive a portion of the inner collar 1260 while preventing the projection 1262 from moving distally until the inner collar 1260 is rotated to a specific position. And the inner collar 1260 may be sized and configured to receive a portion or all of the actuating portion 1282 of the plunger rod 1280. As shown in FIGS. 5A-5C, the proximal collar 1242, the inner collar 1260, and the actuating portion 1282 may all have a generally cylindrical shape. In an alternative embodiment, each of the proximal collar 1242, the inner collar 1260, and the actuating portion 1282 may have any suitable size or shape that allows the actuating portion 1282 to fit (e.g., nest) within the inner collar 1260 and the inner collar 1260 to fit within the proximal collar 1242.

[0165] The plunger rod 1280 and the inner collar 1260 may generally be rotatable (e.g., in one or both directions) about a common longitudinal central axis. Further, both the plunger rod 1280 and the inner collar 1260 may be movable along the longitudinal central axis, e.g., distally, to prime the device 1200 to deliver a quantity of the drug substance from the distal end 1224 of the body 1220, or to prime the device 1200 or deliver a quantity of the drug substance from the distal end 1224 of the body 1220. The actuating portion 1282 of the plunger rod 1280 may include a distal geometry that interfaces with the inner collar 1260 to prevent proximal movement (e.g., backing out) of the plunger rod 1280 from the inner collar 1260 when the actuating portion 1282 moves distally within the inner collar 1260. For example, the actuating portion 1282 may include a wedge-shaped distal portion that expands distally from the inner collar 1260 such that the actuating portion 1282 cannot move freely relative to the inner collar 1260 as it passes through the distal portion of the inner collar 1260.

[0166] The flange piece 1240 may include a cavity, such as a slot 1248, in which a protrusion 1262 of the inner collar 1260 slides when the inner collar 1260 is rotated to a particular position. Similar to the slot 1074 of the device 1050, the slot 1248 may have a depth dimension parallel to the longitudinal axis of the device 1200, and the depth of the slot 1248 may correspond to the distance that the plunger rod 1280 must move distally to push the stopper 1222 toward the discharge end 1224 and dispense a predetermined volume of the formulated drug substance from the body 1220 through the discharge end 1224.

[0167] In some embodiments, device 1200 may have additional features. For example, in some embodiments, the neck of plunger rod 1280 may have a geometric shape complementary to the opening of flange piece 1240 that limits the extent and direction to which plunger rod 1280 rotates or moves longitudinally, similar to neck 1084 and opening 1073 of device 1050. For example, either or both of the rotation and longitudinal movement of plunger rod 1280 may be restricted based on priming, preparation, and / or drug delivery steps during use of device 1200. As another example, plunger rod 1280 may be prevented from being withdrawn or backed out of body 1220 at any point during preparation or use of device 1200.

[0168] In the contemplated use of device 1200, device 1200 may be filled with a predetermined volume of a drug substance. The predetermined volume of the drug substance may be more than the volume of the drug substance suitable for delivery to a patient. In some embodiments, device 1200 (e.g., body 1220) may contain both a predetermined volume of the drug substance and air bubbles (not shown) that must be removed prior to delivery of the drug substance to the patient. In some embodiments, device 1200 may be a prefilled syringe. To prime device 1200 (e.g., remove air bubbles if any and ensure that an appropriate volume of the drug substance is delivered to the patient), the user may push the actuating portion 1282 of plunger rod 1280 into inner collar 1260. The geometry of actuating portion 1282 may interact with inner collar 1260 (e.g., the distal wedge or clip of actuating portion 1282 may expand at the distal side of inner collar 1260) to secure actuating portion 1282 within and / or to inner collar 1260 and prevent backing out of plunger rod 1280. At this point, device 1200 may be in a “primed” state. Subsequently, inner collar 1260 may be rotated about the longitudinal axis until projection 1262 is longitudinally aligned with slot 1248. At this point, device 1200 may be in a “delivery” state. To deliver a predetermined volume of the drug substance from device 1200, inner collar 1260 may then be moved distally with actuating portion 1282 and plunger rod 1280 until projection 1262 abuts the distal end of slot 1248. The distance by which plunger rod 1280 moves in this step may be used to push stopper 1222 distally by a distance necessary to dispense a predetermined volume of the drug substance from the discharge end 1224 of device 1200.

[0169] Next, referring to FIGS. 6A-6E, diagrams of the delivery device 1300 and its components are shown. The delivery device 1300 includes a blocking component having a distal flange piece 1340 and a proximal flange piece 1360, a plunger rod 1380, and a body 1320. The distal flange piece 1340 and the proximal flange piece 1360 each include a flange (1346 and 1366 respectively). The flange 1366 of the proximal flange piece 1360 may optionally include a texture 1365. The distal flange piece 1340 includes a channel 1341 that enables a slidable assembly of the distal flange piece 1340 and the body 1320. The proximal flange piece 1360 includes a clip 1364 that enables the proximal flange piece 1360 and the distal flange piece 1340 to be movably fixed to each other such that they are still rotatable relative to each other about the longitudinal axis of the delivery device 1300 (see FIGS. 6D and 6E for example). The proximal flange piece 1360 includes a clip 1362 adjacent to a central opening 1368 through which the plunger rod 1380 passes. The plunger rod 1380 includes an actuating portion 1382 that optionally includes a texture 1381. The plunger rod 1380 may further include a distal neck shape 1384, a proximal neck shape 1387, and a proximal stop 1386 having a cavity 1385, all of which are configured to interface with the distal flange piece 1340 and the proximal flange piece 1360 in a plurality of configurations. The plunger rod 1380 may further include a distal end 1383 configured such that a tip portion 1383 interfaces with a stopper 1322 at the distal end of a stem 1389. The tip portion 1383 may have any suitable size, shape, and mode of attachment to, fixation to, or pressing on the stopper 1322, as described for example with respect to the tip portion 1083 of the plunger rod 1080. Similar to the stem 1081, the stem 1389 may have any size and configuration suitable for fitting inside the body 1320.In some embodiments, step 1389 may be of a size and configuration with sufficient size (e.g., thickness), stability, and / or rigidity to reduce the likelihood of unwanted bending, wobbling, or breakage.

[0170] The body 1320 (shown in FIGS. 6D and 6E) may have all or some of the same characteristics as, for example, the body 1060 of the device 1050 or any syringe body known in the art. For example, in some embodiments, the body 1320 may be pre-fillable or pre-filled. The stopper 1322 may be configured to be inserted into the body 1320 and may be configured to hold a predetermined volume of the formulated drug substance inside the body 1320 between the stopper 1322 and the discharge end 1324.

[0171] The delivery device 1300 may be, for example, an injection device such as a syringe for dispensing a predetermined volume of the formulated drug substance. Generally, the delivery device 1300 may share size, volume, material, preparation, assembly, or manufacturing characteristics with the device 1050, the device 1200, or other delivery devices disclosed herein. Similar to the devices 1050 and 1200, the delivery device 1300 may be configured to facilitate use and may include one or more features that assist the user by providing tactile feedback, auditory feedback, or visual feedback (texture 1365, 1381, other textures, labels, colors, or any of the features described elsewhere in this specification). Similar to the devices 1050 and 1200, these features are optional and one or more of these features may be combined to improve ease of use.

[0172] To close, partially close, block, or partially block the end of the body 1320 opposite the discharge end 1324, to support and hold the plunger rod 1380 in place inside the body 1320, or for any of these purposes, to function as a blocking component in the delivery device 1300, the proximal flange piece 1360 and the distal flange piece 1340 may be of any suitable size and shape or sizes or shapes. In some embodiments, the proximal flange piece 1360 and the distal flange piece 1340 may each include one or more flanges that are sized and configured to assist the user when holding the device 1300 and discharging the formulated drug substance from the discharge end 1324, or when holding the device 1300 or discharging the formulated drug substance from the discharge end 1324. In some embodiments, as shown in FIGS. 6A-6E, the flange pieces 1360, 1340 may each include two flanges 1366 and 1346 that extend perpendicular to the longitudinal dimension of the device 1300 with each pair of flanges facing each other. Generally, other arrangements of one or more flanges, such as one flange on each of the flange pieces 1360, 1340, are possible. The flange pieces 1340, 1360 may each extend radially outward from the longitudinal central axis of the device 1300 further away from the outer periphery of the body 1320, for example, to support the device 1300 when the device 1300 is placed on a surface, to prevent the device 1300 from rolling on a flat surface, and / or to enable the device 1300 to be more easily picked up.

[0173] The flange pieces 1360 and 1340 may, in combination, form a central opening having a variable size and shape or size or shape depending on the relative position of the proximal flange piece 1360 and the distal flange piece 1340. For example, in the configuration shown in FIG. 6D, the proximal flange piece 1360 and the distal flange piece 1340 may, in combination, form an opening sized and configured to allow distal passage of the distal neck portion 1384 of the plunger rod 1380 but to prevent passage of the proximal neck portion 1387. In the second configuration shown in FIG. 6E (e.g., when the flanges 1346 and 1366 are aligned), the central opening formed by the flange pieces 1360 and 1340 may be sized and configured to allow distal passage of the proximal neck portion 1387. The proximal stop 1386 may be sized and shaped too large to pass through the central opening formed by any combination of the flange pieces 1360 and 1340. In some embodiments, the distal flange 1340 may be assembled to the body 1320 and the plunger rod 1380 such that the distal flange 1340 is not movable relative to the body 1320 and not rotatable relative to the plunger rod 1380. In contrast, the proximal flange 1360 may be assembled to the distal flange 1340 (and the body 1320) to be rotatable about the longitudinal axis relative to the distal flange 1340 passing through the central opening 1368, the body 1320, and the plunger rod 1380. In particular, the proximal flange 1360 may be rotatable relative to the distal flange 1340 from the first configuration (see FIG. 6D) in which the flanges 1346 and 1366 are offset from each other to the second configuration (see FIG. 6E) in which the flanges 1346 and 1366 overlap each other. Those skilled in the art will understand that in alternative embodiments, the distal flange 1340 may be rotatable relative to other components of the device 1300 while the proximal flange 1360 may not be rotatable. In yet another embodiment, both the proximal flange 1360 and the distal flange 1340 may be assembled to the body 1320 and the plunger rod 1380 such that they are both rotatable relative to other components of the device 1300.

[0174] The clip 1362 of the proximal flange piece 1360 may project toward the opening 1368 and may be biased. In a pre-use configuration (shown in FIG. 6D), the clip 1362 may be pushed in by the plunger rod 1380. The clip 1362 may be disposed on the proximal flange piece 1360 such that after distal movement of the plunger rod 1380 such that the distal neck portion 1384 passes through the opening 1368, the clip 1362 expands inwardly and abuts against the side surface of the distal neck portion 1384. When the clip 1362 expands in this manner, the clip 1362 may prevent proximal movement of the plunger rod 1380, for example, to prevent backing out of the plunger rod (see, e.g., FIG. 7C). The cavity 1385 may be disposed on the proximal stop 1386 for each clip 1362 such that each clip 1362 fits into the cavity 1385 when the plunger rod 1380 has moved distally within the body 1320 to the most desirable extent.

[0175] Figures 7A-7F illustrate an exemplary method of using apparatus 1300 according to aspects of the present disclosure. In the pre-use configuration shown in FIG. 7A, apparatus 1300 may hold an amount of drug substance between stopper 1322 and discharge end 1324. Flange pieces 1340 and 1360 may be in a pre-use configuration where flange 1346 and flange 1366 are offset from each other. Plunger rod 1380 that abuts or is assembled to stopper 1322 may be partially inserted into body 1320 through flange pieces 1340, 1360. Proximal flange piece 1360 may be prevented from rotating about the longitudinal axis of the syringe by the geometric shape of plunger rod 1380 and flange piece 1360. In the priming step shown in FIG. 7B, plunger rod 1380 may be further longitudinally moved into body 1320 until distal movement is prevented by the abutment of proximal neck portion 1385 against the surface of proximal flange piece 1360. For example, the user may push actuation portion 1382 towards proximal flange piece 1360. In some embodiments, apparatus 1300 may be held in an inverted position during this step to ensure that air trapped within body 1320 can be discharged by discharge end 1324 as stopper 1322 is pushed distally by plunger rod 1380. In the “primed” configuration, distal neck portion 1384 may be disposed within opening 1368 of proximal flange piece 1360. Further, as shown in FIG. 7C, when the priming step is stopped, clip 1362 may be released from the pushed-in configuration such that they expand internally and abut against the side of distal neck portion 1384. Since distal neck portion 1384 is relatively narrower than the portion of plunger rod 1380 previously disposed within opening 1368, expansion of clip 1362 may prevent proximal movement (e.g., backing out) of plunger rod 1380.

[0176] As shown in FIG. 7D, the device 1300 may be in a primed configuration. In the dispensing preparation step shown in FIG. 7E, by rotating the proximal flange piece 1360 about the longitudinal axis, the flange 1366 and the flange 1346 are aligned, and the shape of the central opening formed by the combined opening of the proximal flange piece 1360 and the distal flange piece 1340 may be changed (e.g., enlarged). To do so, the user may grasp and twist the proximal flange piece 1360. In some embodiments, it may be possible to twist the proximal flange piece in either direction to align the flange 1366 and the flange 1346. In other embodiments, the proximal flange piece 1360 may be rotatable in only one direction. In some embodiments, when the flange 1366 and the flange 1346 are aligned (e.g., as shown in FIG. 7E), further rotation of the plunger rod 1080 relative to the flange piece 1070 may be stopped, for example, by a clip 1362 that abuts against the flange 1346. Thereby, the device 1300 may be locked in a dispensing-prepared configuration. As shown in FIG. 7F, in the dispensing step, the plunger rod 1380 may be further moved longitudinally into the body 1320. For example, the user may push the distal actuator 1382 until each of the clips 1362 enters the cavity 1385 of the proximal stop 1386 and until the proximal stop 1386 abuts against the proximal surface of the proximal flange piece 1360, or at any time in between. The dispensing step may ensure that a predetermined volume of the drug substance is dispensed from the device 1300 into the interior of the body 1320.

[0177] In some embodiments, after each successive step of use of the device 1300, the user may be prevented from both or either re - executing a step and reversing one or more steps. For example, due to the geometric shape (e.g., of the plunger rod 1380 and of the opening where the proximal flange piece 1360 and the distal flange piece 1340 are combined), the user may be prevented from pulling the plunger rod 1380 proximally (e.g., outwards) of the body 1320, rotating the plunger rod 1380, rotating the proximal flange piece 1360 prematurely (e.g., before completion of the priming step as shown in FIGS. 7B and 7C), and / or over - rotating the flange piece 1360 during the dispensing preparation step (e.g., as shown in FIG. 7E).

[0178] FIGS. 8A - 8G show a further exemplary delivery device 1400 and components. The delivery device 1400 includes a plunger rod 1480, a blocking component 1460, a flange piece 1440, and a body 1420. The plunger rod 1480 includes an actuator 1482 and a protrusion 1484. The blocking component 1460 may be a rotatable alignment component that is configured to partially or completely surround the plunger rod 1480 and includes three connected channels 1462, 1464, 1468 sized and configured to allow passage of the protrusion 1484. The flange piece 1440 includes a proximal collar 1442 with a channel 1447 into which a tab 1461 of the blocking component 1460 may slidably fit, a distal collar 1444 with a channel 1445 into which the flange 1421 of the body 1420 may fit (e.g., be slidably assembled), and a flange 1446.

[0179] The body 1420 (shown in FIGS. 8D and 8E) may have all or some of the same characteristics as, for example, the body 1060 of the device 1050, or any syringe body known in the art. For example, in some embodiments, the body 1420 may be pre-fillable or pre-filled. The stopper 1422 may be configured to be inserted into the body 1420 and may be configured to hold a predetermined volume of the formulated drug substance inside the body 1420 between the stopper 1422 and the discharge end 1424.

[0180] The delivery device 1400 may be, for example, an injection device such as a syringe for dispensing a predetermined volume of the formulated drug substance. Generally, the delivery device 1400 may have common size, volume, material, preparation, assembly, or manufacturing characteristics with the device 1050, the device 1200, the device 1300, or other delivery devices disclosed herein. Similar to the other devices disclosed herein, the delivery device 1400 may be configured to facilitate use and may include one or more features that assist the user by providing tactile, auditory, or visual feedback using any of the features described elsewhere in this specification.

[0181] The blocking component 1460 may be of any suitable size and shape, or size or shape, that assists in controlling the proximal and distal movement of the plunger 1480 in the device 1400.

[0182] The flange piece 1440 may be of any suitable size and shape for closing, partially closing, plugging, or partially plugging the end of the body 1420 opposite the discharge end 1424, and for supporting and holding the blocking component 1460 and the plunger rod 1480 with respect to the body 1420, or for any of these purposes. For example, the proximal collar 1442 and the channel 1447 may be sized and configured to hold the blocking component 1460 and the distal collar 1444, and the distal collar 1444 and the channel 1445 may be sized and configured to be held on the flange 1421 of the body 1420 such that the blocking component 1460 is held stationary with respect to the body 1420. Further, the blocking component 1460 may be sized and configured with respect to the plunger rod 1480 inside the body 1420, and may be sized and configured to limit the movement of the plunger rod 1480 with respect to the body 1420. The flange piece 1440 may include one or more flanges 1446 that are sized and configured to assist a user when holding the device 1400 and discharging the formulated active ingredient from the discharge end 1424, or when holding or discharging the formulated active ingredient from the discharge end 1424. In some embodiments, as shown in FIGS. 8A - 8E, the flange piece 1440 may include two flanges 1446 that are opposite each other. Generally, other arrangements of one or more flanges are possible, such as one flange or three flanges. The flange piece 1440 may extend radially outward from the longitudinal central axis of the device 1400, farther from the outer perimeter of the body 1420, for example, to support the device 1400 when the device 1400 is placed on a surface, to prevent the device 1400 from rolling on a flat surface, and / or to enable the device 1400 to be more easily picked up.

[0183] Channels 1462, 1464, 1468 within the blocking component 1460 together form a path through which the projection 1484 moves, enabling controlled movement of the plunger rod 1480. The first channel 1462 may enable sufficient distal movement of the plunger rod 1480 to prime the device 1400. The second channel 1464 may enable movement of the plunger rod between a “primed” state and a “delivery” state. The channel 1464 may have a path that requires rotation of the plunger rod 1480 about the longitudinal axis of the device 1400 (opposite the distal movement of the plunger rod 1480) to reduce the likelihood that the plunger rod 1480 is moved accidentally or unintentionally to the “delivery” state. The channel 1464 may comprise a path of any suitable length (corresponding to any suitable angle of rotation of the plunger rod 1480) to ensure proper separation between the “primed” state and the “delivery” state. The third channel 1468 may enable sufficient distal movement of the plunger rod 1480 to dispense a predetermined volume of the drug substance from the device 1400.

[0184] One or more of each of the channels 1462, 1464, 1468 may include one or more detents. For example, the cross-sectional view of the blocking component 1460 in FIG. 8F shows the interior of the channel 1464 having a small detent 1491 disposed on one side. FIG. 8G shows two larger detents 1492, 1493 in the channels 1462, 1464, respectively. Each detent may provide resistance to movement of the protrusion 1484 through the channels 1462, 1464, and / or 1468 to provide auditory feedback and prevent unintentional movement of the protrusion 1484, or to provide auditory feedback or prevent unintentional movement of the protrusion 1484. In some embodiments, the detents 1491, 1492, 1493 may be angled on one side to allow passage of the protrusion 1484 in one direction but not the other. Detents as shown in FIGS. 8F and 8G may, of course, be suitable for inclusion in any device disclosed herein, not just the device 1400.

[0185] Figures 9A - 9E illustrate an exemplary method of using apparatus 1400 according to aspects of the present disclosure. In the pre - use configuration shown in Figure 9A, apparatus 1400 may hold an amount of drug substance between stopper 1422 and discharge end 1424. Plunger rod 1480 may be partially inserted into body 1420 such that protrusion 1484 of plunger rod 1480 is disposed within the proximal end of channel 1462. In the priming step shown in Figure 9B, plunger rod 1480 may be further longitudinally moved within body 1420 until distal movement is prevented by the abutment of protrusion 1484 against the distal end of channel 1462. For example, the user may push distal actuator 1482 through blocking component 1460. In some embodiments, apparatus 1400 may be held in an inverted position during this step to ensure that air trapped within body 1420 can be discharged as stopper 1422 is pushed distally by plunger rod 1480. In the "primed" configuration shown in Figure 9C, protrusion 1484 of plunger rod 1480 may be disposed at the first end of channel 1464.

[0186] In the dispensing preparation step shown in Figure 9D, plunger rod 1480 may be rotated about its longitudinal axis such that protrusion 1484 is moved from the first end of channel 1464 to the second end of channel 1464. For example, the user may grasp and twist actuator 1482 of plunger rod 1480. Then, apparatus 1400 may be in a dispensing - ready configuration where protrusion 1484 is disposed at the proximal end of channel 1468. As shown in Figure 9E, in the dispensing step, plunger rod 1480 may be further longitudinally moved within body 1420. For example, the user may push distal actuator 1482 until protrusion 1484 abuts the distal end of channel 1468. The dispensing step may ensure that a predetermined volume of drug substance is dispensed from apparatus 1400 into the interior of body 1420.

[0187] In some embodiments, after each successive step in the use of apparatus 1050, the user may be prevented from both or either re-executing a step and reversing one or more steps. For example, the geometric shape of plunger rod 1480, protrusion 1484, and / or channels 1462, 1464, 1468 may prevent, for example, the user from pulling plunger rod 1480 proximally (e.g., outwardly) of body 1420.

[0188] Figures 10A - 10C illustrate an exemplary method of assembling apparatus 1400. As shown in Figure 10A, flange piece 1440 may be slidably assembled to body 1420 such that flange 1421 fits within channel 1445 and collar 1444 partially surrounds body 1420. As shown in Figure 10B, blocking component 1460 may be slidably assembled to flange piece 1440 such that tab 1461 seats within channel 1447 adjacent proximal collar 1442 and within blocking component 1460. Then, as shown in Figure 10C, plunger rod 1480 may be inserted into the combined blocking component 1460, flange piece 1440, and body 1420 such that protrusion 1484 is disposed within channel 1462 of body 1460.

[0189] Figures 10D - 10G, 11A - 11E, and 12A - 12D illustrate variations of the configuration and method of use of apparatus 1400 and are not described in great detail so as to avoid redundancy. Figures 10D - 10G illustrate an alternative assembly method of apparatus 1400, and the blocking component 1460 includes an opening 1463 through which the plunger rod 1480 fits. In this embodiment, channels (e.g., channels 1462, 1468) within the blocking component 1460 may be closed at the proximal and distal ends to prevent backing out or over - insertion of the plunger rod 1480 relative to the body 1420. As shown in FIG. 10E, the plunger rod 1480 may be partially inserted into the body 1420, and the flange piece 1440 may be slidably assembled to the body 1420 such that the flange 1421 fits within the channel 1445 and the collar 1444 partially surrounds the body 1420. As shown in FIG. 10F, the blocking component 1460 may be assembled to the plunger rod 1480 such that the protrusion 1484 is disposed within one of the channels within the blocking component 1460. As shown in FIG. 10G, the blocking component 1460 may then be assembled to the flange piece 1440 such that it is disposed within the channel 1447. The blocking component may be secured to the flange piece 1440 in any suitable manner (e.g., using a clip, adhesive, friction fit, dovetail connection, etc.). Figures 12A - 12D show enlarged views of the protrusion 1484 moving through the channels of the blocking component 1460 by the method of use shown in FIGS. 11A - 11E.

[0190] Figures 13A and 13B show a further exemplary delivery device 1500 and a method of assembling the delivery device according to a further embodiment of the present disclosure. The device 1500 includes a plunger rod 1580, a blocking component in the form of a flange piece 1540, and a body 1520. To assemble the device 1500, the plunger rod may be inserted into the body 1520 so as to be adjacent to or attached to a stopper 1522 within the body 1520 (e.g., as shown in FIG. 13A), and the flange piece 1540 may be slidably assembled to 1521, for example, by sliding a channel 1541 over a flange 1521 of the body 1520 (e.g., as shown in FIG. 13B). An opening 1543 may allow the flange piece 1540 to be assembled to the body 1520 around the plunger rod 1580. Alternative assembly methods are contemplated depending on the size, shape, and structure of each component of the device 1500.

[0191] The delivery device 1500 may be, for example, an injection device such as a syringe for dispensing a predetermined volume of formulated active ingredient. Generally, the delivery device 1500 may share size, volume, material, preparation, assembly or manufacturing characteristics with the device 1050, the device 1200, the device 1300 or other delivery devices disclosed herein. Similar to the other devices disclosed herein, the delivery device 1500 may be configured to facilitate use and may include one or more features that assist the user by providing tactile, auditory or visual feedback using any of the features described elsewhere in this specification.

[0192] Figures 14A - 14F show diagrams of a further device 1500 and a method of using the device 1500. As shown in Figure 14A, the plunger rod 1580 may include an actuating portion 1582, a proximal stop 1588, a proximal neck portion 1586, and a distal neck portion 1584. The body 1520 may have all or some of the same features as, for example, the body 1060 of the device 1050 or any syringe body known in the art. For example, in some embodiments, the body 1520 may be pre - fillable or pre - filled. The stopper 1522 may be configured to be inserted into the body 1520 and may be configured to hold a predetermined volume of formulated drug substance inside the body 1520 between the stopper 1522 and the discharge end 1524.

[0193] The flange piece 1540 may be of any suitable size and shape for partially closing, closing, or partially occluding the end of the body 1520 opposite the discharge end 1524, for supporting and holding the plunger rod 1580 within the body 1520, or for any of these purposes. The opening 1542 may have a size and shape configured to allow passage of the plunger rod 1580 in two different configurations. The distal neck portion 1584 and the proximal neck portion 1586 may have similar shapes but may be rotationally offset from each other (for example, when the distal neck portion 1584 passes through the opening 1542, the plunger rod 1580 must be rotated about its longitudinal axis to pass through the proximal neck portion 1587). The distal neck portion 1584 may include a tapered distal side, for example, that helps to orient the plunger rod 1580 so that the distal neck portion 1584 can pass through the opening 1542. This may, for example, enhance the ease of the priming step.

[0194] Figure 14A shows the pre-use configuration of the device 1500. In such a configuration, the device 1500 may hold an amount of the drug substance between the stopper 1522 and the discharge end 1524. The plunger rod 1580 may be partially inserted into the main body 1520 such that the distal neck portion 1584 is disposed proximal to the flange piece 1540. In the priming step shown in Figure 14B, the plunger rod 1580 may be further longitudinally moved into the main body 1520 until the proximal movement is prevented by the abutment of the proximal neck portion 1586 against the opening 1542 (as shown in Figure 14C). For example, the user may push the actuating portion 1582 until the distal neck portion passes through the opening 1542. In some embodiments, the device 1500 may be held in an inverted position during this step to ensure that the air trapped within the main body 1520 can be discharged as the stopper 1522 is pushed distally by the plunger rod 1580. In the "primed" state shown in Figure 14D, the proximal neck portion 1586 may be disposed against the surface of the flange piece 1540.

[0195] In the dispensing preparation step shown in Figure 14D, the plunger rod 1580 may be rotated about the longitudinal axis such that the shape of the proximal neck portion 1586 is aligned with the opening 1542. For example, the user may grasp and twist the actuating portion 1582 of the plunger rod 1580. The device 1500 may then be in a dispensing preparation completed configuration. As shown in Figure 14E, in the dispensing step, the plunger rod 1580 may be further longitudinally moved into the main body 1520. For example, the user may push the actuating portion 1582 distally until the proximal stop 1588 abuts against the surface of the flange piece 1540. The dispensing step may ensure that a predetermined volume of the drug substance is dispensed from the device 1500 into the interior of the main body 1520.

[0196] In some embodiments, after each successive step in the use of apparatus 1500, the user may be prevented from both or either re - executing a step and reversing one or more steps. For example, the geometric shapes of plunger rod 1580, distal neck portion 1584, proximal neck portion 1586, and opening 1542 may interface with each other, for example, to prevent the user from pulling the plunger rod 1580 proximally (e.g., outwardly) of the body 1520.

[0197] Next, further variations such as blocking components, dose control components, etc. will be described. FIGS. 15A - 23C show exemplary plunger rod dials according to further embodiments of the present disclosure. For example, FIG. 15A shows a plunger rod 1600 having an actuating portion 1610. The actuating portion 1610 may have a shape that generally corresponds to the flange piece 1640. The plunger rod 1600 may be rotatable with respect to both or either the flange piece 1640 and the apparatus body. The apparatus may be configured, for example, to be suitable for delivering a desired amount of active ingredient when the shape of the plunger rod 1610 is generally aligned with the shape of 1640 (as shown in the top view of FIG. 15A). As another example, FIG. 15B shows an actuating portion 1610' with a ridged side surface to allow for easier rotation of the plunger rod 1600' with respect to the flange piece 1640 and the rest of the syringe or the flange piece 1640 or the rest of the syringe. FIG. 16A shows an actuating portion 1610'' with a ribbed side surface to similarly allow for easier rotation of the plunger rod 1600. FIG. 16B shows an exemplary combination of the actuating portion 1610'' and the apparatus 1500. Those skilled in the art will understand that any of the actuating portions or other features described herein may be combined with the apparatus described herein.

[0198] FIG. 17 shows an exemplary plunger rod and dial according to a further embodiment of the present disclosure. The actuating portion 1612 may be sized and configured to fit into the color 1642 of the flange piece 1640’ only in a specific configuration. The depth of the color 1642 may correspond, for example, to the distance that the plunger rod 1600 must move to dispense a predetermined volume of the active ingredient from the drug delivery device. In one embodiment, the actuating portion 1612 may be moved distally until it abuts the color 1642, and then rotated until its shape corresponds to the shape of the color 1642 such that the actuating portion 1612 is pushed into the color 1642 during the dispensing step. FIGS. 18A and 18B show further exemplary plunger rods and dials that combine exemplary features to enable accurate dose delivery. The plunger rod may include, for example, protrusions 1684 and 1682 that fit through respective openings 1641’ in the flange piece 1680 in a specific configuration. The protrusions 1682 and 1684 may each correspond to the distance required to deliver the required amount of the active ingredient from the device, and / or to prime the device, or for any of these purposes. The actuating portion 1650 may include a raised portion 1652 that assists the user when turning the plunger rod relative to the flange piece 1680.

[0199] FIGS. 19A and 19B show top views of the flange piece 1740 and the plunger rod 1720. The flange piece 1740 and the plunger rod 1720 may have a cross-sectional shape that enables limiting the rotation of the plunger rod 1720 relative to the flange piece 1740 to a single direction. For example, the flange piece 1740 may have internal protrusions that resist the first portion of the plunger rod 1720 when the first portion rotates past the internal protrusions and stop the second portion of the plunger rod 1720 when the second portion abuts the internal protrusions, such that interaction with the irregular cross-sectional shape of the plunger rod 1720 is possible.

[0200] FIG. 20 shows an exemplary flange piece 1750 having a well 1760 with a clip 1762. The plunger rod actuator 1780 may be pushed distally into the well 1760 until the clip 1762 covers the actuator 1780, for example, to prevent the backing out of the plunger rod and hold the actuator 1780 in place. The plunger rod includes a distal protrusion 1781 and a proximal protrusion 1783 that are sized to fit through the opening 1764 whenever the plunger rod is rotated to a particular position. The distal protrusion 1781 includes a tapered distal side that helps to orient the plunger rod in a position necessary to move the plunger rod distally so that the distal protrusion 1781 passes through the opening 1764. This may, for example, enhance the ease of the priming step. In some embodiments, the height of both or either the well 1760 and the actuator 1780 may correspond to the height that the plunger rod must move to dispense a predetermined volume of the drug substance. Thus, the device may be primed when the actuator 1780 is adjacent to the proximal side of the well 1760 and deliver a predetermined volume of the drug substance as the actuator 1780 moves distally into the well 1760.

[0201] FIG. 21 shows an exemplary device 1800 having a flange piece 1840 complementary to the plunger rod 1820. The plunger rod 1820 may include, for example, projections 1844, 1846 having an angle or wedge corresponding to the shape of one or more openings 1842 within the flange piece 1840. The wedge or angled shape of the projections 1844, 1846 and the openings 1842 need only be sufficient to resist distal movement of the plunger rod 1820 when the projection 1844 or 1846 abuts against the side surface of the opening 1842, and may be capable of moving past each other when sufficient force is applied. The resistance provided by the abutment of the projections 1844, 1846 against the side surfaces of the openings 1842 may be sufficient to indicate to the user that a particular step in the use of the device 1800 has been completed. The user may then apply sufficient force to move the plunger rod 1820 beyond the resistance and proceed to the next step (e.g., from a completed priming step to a delivery preparation step).

[0202] As described elsewhere, any of the devices disclosed herein may be combined with tactical feedback in the form of labels, auditory feedback, and / or symbols (e.g., lock symbol 1850, unlock symbol 1852, mountain brackets 1856 on the actuator 1854 shown in FIG. 22). Rotation of the plunger rod may also be accompanied by a "click" sound.

[0203] FIGS. 23A-23C show further exemplary combinations of components in a delivery device. For example, the plunger rod actuator 1650 may include, for example, a ribbed side surface and a raised portion 1652 that helps to turn the actuator. A device with these characteristics may include, for example, the opening 1842 and corresponding angled projections 1844, 1846 (described with respect to FIG. 21).

[0204] Figures 24A-24E illustrate a further exemplary delivery device 1900 and a method of using device 1900. Device 1900 may include an actuator 1940 and a blocking component 1980 shown on plunger rod 1920. Plunger rod 1240 may abut a stopper 1912 within body 1910. Blocking component 1980 may be rotatable relative to plunger rod 1920. In the pre-use configuration shown in Figure 24B, blocking component 1980 may be in a first position relative to plunger rod 1920 and flange piece 1960. In the priming step shown in Figure 24C, plunger rod 1920 may be further longitudinally moved within body 1910 until distal movement is prevented by the abutment of blocking component 1980 against a recess 1962 within flange piece 1960. For example, a user may distally press actuator 1940 towards flange piece 1960. In the dispensing preparation step shown in Figure 24D, blocking component 1980 may be rotated such that the short side of blocking component 1980 faces flange piece 1960. Recess 1962 may be curved to allow for ease of rotation of blocking component 1980. The distance between blocking component 1980 and flange piece 1960 after blocking component 1980 is rotated may correspond to the distance that plunger rod 1920 may move to dispense a predetermined volume of a drug substance from device 1900. As shown in Figure 24E, in the dispensing step, plunger rod 1920 may be further longitudinally moved within body 1910 until the rotated blocking component 1980 abuts flange piece 1960 in a second position. For example, a user may distally press actuator 1940 until the protruding blocking component abuts flange piece 1960. The dispensing step may ensure that a predetermined volume of a drug substance is dispensed from device 1900 into the interior of body 1910.

[0205] Figures 25A-25E show a further exemplary delivery device 2000 and method of using the delivery device 2000. The plunger rod 2080 of the device 2000 may include a screw 2100 corresponding to an internal thread (not shown) of the flange piece 2062. As shown in Figure 25A, the plunger rod 2080 may be rotatable relative to other parts of the device 2000. The plunger rod 2080 must be in a specific configuration and position that allows either or both of the protrusion 2082 to enter and pass through the flange piece 2060 so as to be able to correspond to the opening 2062 within the flange piece 2062. The plunger rod 2080 may also include a protrusion 2082 located proximal to the screw 2100 (see, for example, Figure 25B). In the pre-use configuration shown in Figure 25C, the screw 2100 and the protrusion 2082 may be disposed proximal to the flange piece 2060. In the priming step, the plunger rod 2080 may be rotated relative to the internal thread of the flange piece 2060 until the screw 2100 passes through the flange piece 2060, and until further rotation or distal movement of the plunger rod 2080 is prevented by the protrusion 2082, or at any time thereof. In the dispensing preparation step, the protrusion 2082 may be moved towards the opening 2062. In the dispensing step, the protrusion 2082 may be moved through the opening 2062 to further advance the plunger rod 2080 and dispense a predetermined volume of the drug substance into the interior of the body of the device 2000.

[0206] Figures 26A - 26E show a delivery device 2200 having further variations of the dosage control component. For example, the device 2200 includes a plunger rod 2280 with one or more clips 2284 each configured to slide distally within channel 2242 of flange piece 2240 and, once distally slid, resist (e.g., prevent or resist backing out of) proximal sliding out of channel 2242. The flange piece 2240 may further have a second channel 2244 and a third channel 2246 through which each of the clips 2284 slide during the delivery preparation step and the dosage delivery step, as described above. Alternatively, as shown in Figure 26B, channel 2242’ may have an open proximal end through which projection 2284’ moves to allow either or both proximal and distal movement of plunger rod 2280 relative to flange piece 2240’. As shown in Figure 26C, in the pre - use configuration, clip 2284 may be disposed proximally of channel 2242 of flange piece 2240. During the priming step, plunger rod 2280 may be moved distally within the body of device 2200 until clip 2284 moves into channel 2242 and abuts the distal end of channel 2242. During the dispensing preparation step, plunger rod 2280 may be rotated relative to flange piece 2240. During the dispensing step, plunger rod 2280 may be moved further distally within the body of device 2200 to dispense a predetermined volume of the drug substance from device 2200.

[0207] In other embodiments, as shown in FIGS. 26F - 26G, the flange piece 2240'' may include one or more protrusions 2246'' disposed within the collar 2242''. In this example, the collar 2242'' may include a pair of protrusions 2246'' that extend radially inwardly from the inner surface of the collar 2242'' in opposite directions from each other. For example, the protrusions 2240'' may be disposed approximately 180 degrees apart from each other. It will be understood that the flange piece 2240'' may include more and / or fewer protrusions 2246'' than those described and illustrated herein without departing from the scope of the present disclosure. The flange piece 2240'' may be configured to engage the plunger rod 2080'' in response to the receipt of the protrusions 2246'' by the plunger rod 2280''.

[0208] As seen in FIG. 26G, the plunger rod 2280'' may include an actuating member 2284'' defined by a proximal end 2282'' and a distal end 2283''. The plunger rod 2280'' may include a series of channels along opposing sides of the actuating member 2284'', such as a first channel 2286'', a second channel 2288'', and a third channel 2290'', disposed, for example, between the proximal end 2282'' and the distal end 2283''. The first channel 2286'' is offset from the third channel 2290'' and is connected to the third channel 2290'' by the second channel 2288'' disposed therebetween. As will be described in detail below, the first channel 2286'' may define a longitudinal and axial priming path of the plunger rod 2280'', the second channel 2288'' may define a circumferential path of the plunger rod 2280'', and the third channel 2290'' may define a longitudinal and axial administration completion path. It will be understood that both or one of the opposing surfaces and sides (not shown) of the actuating member 2284'' may include a substantially similar series of interconnected first channel 2286'', second channel 2288'', and third channel 2290'' as seen in FIG. 26G. In this example, the first channel 2286'' and the third channel 2290'' may be aligned parallel to each other.

[0209] The first channel 2286'', the second channel 2288'', and the third channel 2290'' may be sized, shaped, and configured to receive at least one of the pair of protrusions 2246''. As detailed above, by connecting the plunger rod 2280'' to the flange piece 2240'', the protrusion 2246'' may project and slide through the first channel 2286'', the second channel 2288'', and the third channel 2290'' to prime the device 2200 and deliver a dose from the device 2200 (FIG. 26A). In some embodiments, the first channel 2286'' may have an open end at the proximal end 2282'' through which the protrusion 2246'' can be received. In some embodiments, the first channel 2286'' may have a closed proximal end, and the protrusion 2246'' may be at least partially flexible and deformable or flexible or deformable such that when received at the proximal end of the first channel 2286'', the protrusion 2246'' bends radially outward. In other embodiments, the first channel 2286'' may have a tapered, chamfered, and / or tapered end to facilitate guiding of the protrusion 2246'' toward the second channel 2288''. In this example, the tapered end may prevent retraction (e.g., proximal movement) of the plunger rod 2280'' relative to the flange piece 2240''. The longitudinal length of the first channel 2286'' may define an axial priming path (e.g., a quantity or degree of priming) configured to facilitate either or both proximal and distal movement of the plunger rod 2280'' relative to the flange piece 2240''. For example, the protrusion 2246'' may be disposed proximal to the proximal end of the first channel 2286'' and the proximal end of the second channel 2288'' when the device 2200 is in an assembled state. In the priming step, the plunger rod 2280'' may be moved distally relative to the flange piece 2240'' until the protrusion 2246'' is disposed within the second channel 2288'' and at the distal end of the first channel 2286''. The second channel 2288'' may define a circumferential path of the plunger rod 2280''.

[0210] In the dispensing preparation step, the plunger rod 2280'' may be rotated relative to the flange piece 2240'' to laterally translate the protrusion 2246'' through the circumferential path of the second channel 2288'' and toward the administration completion path defined by the third channel 2290''. In some embodiments, both or one of the plunger rod 2280'' and the flange piece 2240'' may be configured to generate user feedback (such as tactile, sound, visual, etc.) when the device 1050 is in the dispensing preparation step. In the dispensing step, the plunger rod 2280'' may be moved distally within the body of the device 2200 to dispense a controlled volume of material by translating the protrusion 2246'' through the third channel 2290''. The longitudinal length of the third channel 2290'' may define a dose delivery path (such as a dosage). It will be understood that the axial priming path (the length of the first channel 2286'') may be different from the dose delivery path (the length of the third channel 2290''). In other embodiments, the plunger rod 2280'' may include more and / or fewer channels along the actuating member 2284'' (such as corresponding to the number of protrusions 2246'' on the flange piece 2240''), and may have various other related channel configurations different from those described and explained herein.

[0211] Figures 27A - 27H illustrate an exemplary delivery device 2300 and a method of using the delivery device 2300. The actuating portion 2350 may also function as a blocking component of the device 2300. The actuating portion 2350 may be slidably coupled to the plunger rod 2380 in two configurations via the channel 2352. As shown in Figure 27B, one side of the actuating portion 2350 may include a channel 2354. The depth of the channel 2354 may correspond to the distance that the plunger rod can move to dispense a predetermined volume of the drug substance after priming of the device 2300. As shown in Figures 27C and 27D, in the pre - use configuration, the actuating portion 2350 may be assembled on the plunger rod 2380 such that the flat side surface of the actuating portion 2350 faces the collar 2360 of the device 2300. In the priming step, the actuating portion 2350 may be used to move the plunger rod 2380 distally until the flat side surface 2356 of the actuating portion 2350 abuts the proximal side of the collar 2360. For use in the dose delivery step, the actuating portion 2350 may be removed from the plunger rod 2380 and may be rotated or reversed and reassembled on the plunger rod 2380 such that the channel 2354 faces the collar 2360, as shown in Figures 27F and 27G. In the dose delivery step, the actuating portion 2350 may be used to further push the plunger rod 2380 distally until the proximal end of the collar 2360 abuts the inner end of the channel 2354. This movement of the plunger rod 2380 may be sufficient to dispense a predetermined dose of the drug substance from the device 2300.

[0212] Figures 28A-28C illustrate an exemplary delivery device 2400 and a method of using the delivery device 2400. Since the delivery device 2400 includes substantially the same features as those shown and described above, the same reference numbers may be used to identify similar components. As shown in FIG. 28A, the delivery device 2400 may include a removable clip 2402 coupled to the body 1060 at a position distal to the flange piece 1070. The removable clip 2402 may be an obstruction and blocking component or an obstruction or blocking component configured to prevent movement of the flange piece 1070 relative to the body 1060. The removable clip 2402 is selectively removable such that the removable clip 2402 is configured to engage and disengage the body 1060 in response to manual operation of the removable clip 2402.

[0213] As an exemplary example, the removable clip 2402 may have a body configured to wrap around the exterior of the body 1060 and apply a force to the body 1060 to selectively deform (e.g., break, tear, etc.) and then separate the removable clip 2402 from the body 1060. In other examples, the removable clip 2402 may have a flexible body configured to bend in response to a radially outward force being applied to disengage the removable clip 2402 from the body 1060. In a further example, the removable clip 2402 may have a body configured to selectively transition between a closed configuration that encloses the outer periphery of the body 1060 therein and an open configuration that allows the body 1060 to be removed from the body of the removable clip 2402. The removable clip 2402 may include other suitable sizes, shapes, and / or configurations different from those described and illustrated herein without departing from the scope of the present disclosure.

[0214] The delivery device 2400 may include a radial wall 1063 that forms an obstacle along the body 1060 by extending laterally outward from the outside of the body 1060. As seen in FIG. 28A, the radial wall 1063 may be configured to prevent distal translation of a removable clip 2402 along the body 1060. In some embodiments, the radial wall 1063 may be an additional component attached to the body 1060, while in other embodiments, the radial wall 1063 may be integrally formed on the body 1060. Referring now to FIG. 28B, the flange piece 1070 and the plunger rod 1080 may be configured to translate distally along the body 1060 to prime the delivery device 2400 after removal of the removable clip 2402 from the body 1060. In this example, the plunger rod 1080 may remain stationary relative to the flange piece 1070 as the assembly of the flange piece 1070 and the plunger rod 1080 moves relative to the body 1060. In other embodiments, the plunger rod 1080 may remain stationary as the flange piece 1070 translates distally along the body 1060 to prime the delivery device 2400. For example, at least a portion of the flange piece 1070 may extend into the body 1060 (e.g., behind the stopper 1062) when priming the device 2400. In this example, the plunger rod 1080 may be translated separately to deliver a dose from the delivery device 2400.

[0215] By translation of the flange piece 1070 from a proximal position (FIG. 28A) to a distal position (FIG. 28B), the delivery device 2400 may be in a primed position. It will be appreciated that the body 1060 may be configured to limit movement by the flange piece 1070 to a distance defined based on the position of the radial wall 1063 that may correspond to the priming distance of the delivery device 2400. Accordingly, the priming distance of the delivery device 2400 may be controlled by adjusting the range of movement of the flange piece 1070 along the body 1060.

[0216] As shown in FIG. 28C, the plunger rod 1080 may be translated distally relative to the body 1060 in response to a distal force being applied to the actuator 1082. In this example, the stem 1081 may be translated relative to the flange piece 1070 to move the stopper 1062 within the body 1060 to deliver a dose. It will be understood that the extent of movement of the plunger rod 1080 relative to the flange piece 1070 may define the dose delivery distance of the delivery device 2400. The dose delivery distance may be controlled based on the gap formed between the collar 1072 and the actuator 1082.

[0217] In other embodiments, as shown in FIGS. 28D-28F, the delivery device 2400 may further include a locking component, such as a removable rod 2404 coupled to the flange piece 1070. Referring particularly to FIG. 28D, the removable rod 2404 may be received through the proximal end of the collar 1072 through one or more side openings (not shown) formed, for example, through the collar 1072. The removable rod 2404 may be configured to prevent movement of the plunger rod 1080 relative to the flange piece 1070, such as preventing receipt of the actuator 1082 into the collar 1072. The removable rod 2404 may be selectively removable and may be configured to engage and disengage the collar 1072 after manual operation of the removable rod 2404. It will be understood that the delivery device 2400 may include various other locking components, such as pins, tabs, bars, etc., in addition to and / or instead of the removable rod 2404.

[0218] For example, referring to FIG. 28E next, the flange piece 1070 and the plunger rod 1080 (e.g., the stem 1081 and the actuator 1082) may be configured to translate distally along the body 1060 to prime the delivery device 2400 in response to the removal of the removable clip 2402 from the body 1060. The plunger rod 1080 may remain stationary relative to the flange piece 1070 when the assembly of the flange piece 1070 and the plunger rod 1080 moves relative to the body 1060. As the flange piece 1070 translates from the proximal position (FIG. 28D) to the distal position (FIG. 28E), the delivery device 2400 may be in the primed position. It will be appreciated that the body 1060 may be configured to limit the movement by the flange piece 1070 to a distance defined based on the position of the radial wall 1063 along the body 1060 that may correspond to the priming distance of the delivery device 2400.

[0219] As seen in FIG. 28F, the removable rod 2404 may be disengaged from the collar 1072 such that the plunger rod 1080 is no longer prevented from moving distally relative to the flange piece 1070. The actuator 1082 may be translated within the collar 1072 to move the stem 1081 and the stopper 1062 within the body 1060 to deliver a dose. The degree to which the plunger rod 1080 translates relative to the flange piece 1070 may define the dose delivery distance of the delivery device 2400.

[0220] In other embodiments, as seen in FIGS. 28G - 28I, the removable clip 2402 may be completely omitted such that the delivery device 2400 includes one obstacle and blocking component or one obstacle or blocking component, namely the rod 2404. In this example, the flange piece 1070 may be fixed relative to the body 1060. As the actuator 1082 is positioned proximal to the rod 2404 and the plunger rod 1080 is translated distally towards the flange piece 1070 until it touches the rod 2402, the delivery device 2400 may be primed. It will be understood that both or either of the flange piece 1070 and the rod 2404 may be configured to prevent distal movement of the plunger rod 1080 relative thereto when no distal - directed force is applied thereto. In other examples, the delivery device 2400 may include a blocking component (such as a removable clip 2404) disposed between the actuator 1082 and the rod 2404 to prevent distal translation of the plunger rod 1080.

[0221] Accordingly, when the delivery device 2400 is in an assembled pre - primed state (FIG. 28G), the priming distance of the delivery device 2400 may be defined by the distance between the distal end of the actuator 1082 and the rod 2404. As seen in FIG. 28H, engaging the actuator 1082 with respect to the rod 2402 may cause the delivery device 2400 to be in a primed state. The rod 2402 may be removed from the collar 1072 to allow further translation of the plunger rod 1080 distally relative to the flange piece 1070. As shown in FIG. 28I, a dose may be delivered from the delivery device 2400 in response to the reception of the actuator 1082 by the collar 1072. It will be understood that the longitudinal offset between the distal end of the actuator 1082 and the inner surface of the collar 1072 may be a determining factor for the dose delivery distance. Accordingly, the extent to which the plunger rod 1080 translates relative to the flange piece 1070 (e.g., the dose delivery distance) may define the amount of dose delivered by the delivery device 2400.

[0222] In a further embodiment, as shown in FIGS. 28J-28L, the delivery device 2400 may include a fixed clip 2406 attached to the body 1060 at a relatively distal position of the removable clip 2402. The fixed clip 2406 may be arranged in contact with the removable clip 2402 as an obstacle and a blocking component or an obstacle or a blocking component so that the fixed clip 2406 is configured to prevent the movement of the removable clip 2402 along the body 1060. When the flange piece 1070 is disposed proximal to the removable clip 2402, the fixed clip 2406 may be further configured to prevent the movement of the flange piece 1070 when the removable clip 2402 is disposed therebetween.

[0223] Referring next to FIG. 28K, to prime the delivery device 2400, the flange piece 1070 may be configured to translate distally along the body 1060 after removing the removable clip 2402 from the body 1060. In this example, the plunger rod 1080 may remain stationary relative to the flange piece 1070 when the assembly of the plunger rod 1080 and the flange piece 1070 moves toward the fixed clip 2406. Translating the flange piece 1070 from a proximal position (FIG. 28J) engaging with the fixed clip 2406 to a distal position (FIG. 28K) may cause the delivery device 2400 to be in a primed position. It will be appreciated that the body 1060 may be configured to limit the movement of the flange piece 1070 to a defined distance that may correspond to the priming distance of the delivery device 2400.

[0224] As shown in FIG. 28L, the plunger rod 1080 may be translated distally relative to the body 1060 in response to a distal force being applied to the actuator 1082. The stem 1081 may move relative to the flange piece 1070 to move the stopper 1062 within the body 1060 to deliver a dose. It will be appreciated that the extent to which the plunger rod 1080 translates relative to the flange piece 1070 may define the dose delivery distance of the delivery device 2400. The dose delivery distance may be controlled based on the position of the fixed clip 2406 along the body 1060.

[0225] In a further embodiment, the delivery device 2400 may include a sleeve 2408 extending distally from the flange piece 1070, as shown in FIG. 28M. The sleeve 2408 may be attached to the distal end of the flange piece 1070 to form an integral structure by being integral with the flange piece 1070, or by being attached to or integral with the distal end of the flange piece 1070. The sleeve 2408 is disposed within the body 1060 and may include a distal end 2410. The sleeve 2408 may define a lumen sized and shaped to receive the stem 1081 when the plunger rod 1080 is coupled to the flange piece 1070. As will be described in more detail herein, the sleeve 2408 may be configured to move within the lumen of the body 1060 in response to translation of the flange piece 1070 along the exterior of the body 1060.

[0226] The sleeve 2408 may further include a locking component, such as a second protrusion 2412 formed along the inner surface of the sleeve 2408 (such that the second protrusion 2412 extends at least partially within the lumen defined by the sleeve 2408). In this embodiment, the second protrusion 2412 is disposed relatively proximally to the distal end 2410. In other embodiments, the sleeve 2408 may include various other suitable locking components, such as an opening sized, shaped, and configured to receive the protrusion 1085, instead of the second protrusion 2412.

[0227] Referring particularly to FIG. 28M, when the plunger rod 1080 is received through the flange piece 1070 and the sleeve 2408, the protrusion 1085 extends radially outward from the stem 1081 and may be disposed proximal to the second protrusion 2412. To prime the delivery device 2400, the plunger rod 1080 may be translated distally relative to the flange piece 1070 and the sleeve 2408 until the protrusion 1085 contacts the second protrusion 2412. It will be understood that the extent to which the plunger rod 1080 translates relative to the sleeve 2408 may define the priming distance of the delivery device 2400. The priming distance may be controlled based on the relative positions of the protrusion 1085 and the second protrusion 2412.

[0228] As shown in FIG. 28N, when the protrusion 1085 is engaged with the second protrusion 2412 and the distal end of the actuating portion 1082 is received in the inner surface of the collar 1072, the plunger rod 1080 may be connected to the sleeve 2408 and the delivery device 2400 may be in a primed state. The actuating portion 1082 may be fully received within the collar 1072 and the stem 1081 may be locked onto the sleeve 2408. Thus, further translation of the plunger rod 1080 may provide translation of the flange piece 1070 and the sleeve 2408 relative to the body 1060. For example, as seen in FIG. 28O, the plunger rod 1080 and the flange piece 1070 may translate distally relative to the body 1060 in response to a distal force being applied to the actuating portion 1082. The stem 1081 may move relative to the body 1060 to move the stopper 1062 within the body 1060 in order to deliver a dose.

[0229] The distal end 2410 may translate toward the discharge end 1064 as the plunger rod 1080 and flange piece 1070 move distally until they contact the fixed clip 2406. It will be appreciated that the extent to which the plunger rod 1080 and flange piece 1070 translate may define the dose delivery distance of the delivery device 2400. The dose delivery distance may be controlled based on the position of the fixed clip 2406 along the body 1060.

[0230] In other embodiments, as seen in FIGS. 28P-28Q, the delivery device 2400 may include an obstruction and blocking component or obstruction or blocking component in the form of a handle 2420. The handle 2420 may include a body 2422 having a circular cross-section that defines a central opening 2424. The body 2422 may be formed of a variety of flexible materials including, for example, plastic, rubber, and the like. As will be described in more detail herein, the handle 2420 may be frangible and deformable or may be frangible or deformable in response to a force being applied to the body 2422. The handle 2420 extends outwardly from the body 2422 and may further include a grippable feature 2426 configured to facilitate manual operation of the handle 2420. As seen in FIG. 28P, the grippable feature 2426 may be integrally formed with the body 2422 such that applying a radially outward force (e.g., a pulling force) on the grippable feature 2426 causes the body 2422 to deform (e.g., be torn, broken, etc.) as shown in FIG. 28Q.

[0231] Next, referring to FIG. 28R, the handle 2420 may be fixed to the flange piece 1070 along the proximal end of the collar 1072. The handle 2420 may be disposed on the collar 1072 so as to be separated from the actuating portion 1082 by the handle 2420 disposed therebetween. The stem 1081 may be received into the collar 1072 through the central opening 2424 when the body 2422 is attached to the collar 1072. The handle 2420 may be configured to prevent the actuating portion 1082 from translating into the collar 1072. Both or one of the thickness and width of the body 2422 may be sized such that the diameter of the central opening 2424 is smaller than the diameter of the actuating portion 1082, preventing the actuating portion 1082 from passing through the handle 2420.

[0232] As seen in FIG. 28S, the delivery device 2400 may be primed in response to translating the plunger rod 1080 distally relative to the flange piece 1070 until contacting the body 2422. It will be understood that the extent to which the plunger rod 1080 translates relative to the flange piece 1070 may correspond to the priming distance of the delivery device 2400. The priming distance may be controlled based on the thickness of the body 2422, thereby changing the relative distance between the actuating portion 1082 and the collar 1072. Once the actuating portion 1082 engages the body 2422, the grippable feature 2426 may be actuated to remove (e.g., break, tear, pull, etc.) the handle 2420 from the collar 1072. In this example, the body 2422 may be deformed (see FIG. 28Q), disengaged from the flange piece 1070, thereby allowing the plunger rod 1080 to translate further distally relative to the flange piece 1070.

[0233] As shown in FIG. 28T, the actuating part 1082 may be received within the collar 1072 in response to applying a distal direction force to the actuating part 1082. The stem 1081 may move relative to the body 1060 to move the stopper 1062 within the body 1060 in order to deliver a dose. It will be understood that the extent of translation of the plunger rod 1080 relative to the collar 1072 may correspond to the dose delivery distance of the delivery device 2400. The dose delivery distance may be controlled based on the thickness of the pull tab 2420, whereby the relative distance between the actuating part 1082 and the distal (e.g., bottom) end of the collar 1072 changes.

[0234] In a further embodiment, as shown in FIGS. 28U-28X, the delivery device 2400 may include a removable cap 2430 coupled to the plunger rod 1080. The removable cap 2430 may include a body 2432 defining a cavity 2434 sized and shaped to receive at least a portion (e.g., the actuating part 1082) of the plunger rod 1080 therein. The removable cap 2430 may include an opening along the bottom (e.g., distal) wall of the body 2342 for receiving the stem 1081. In some embodiments, the removable cap 2430 may be attached to the actuating part 1082, while in other embodiments, the body 2342 may be directly coupled to the stem 1081. The removable cap 2340 may be an obstruction and blocking component or an obstruction or blocking component configured to increase the cross-sectional profile of the actuating part 1082 to prevent translation of the plunger rod 1080 relative to the flange piece 1070, and more particularly to prevent movement of the actuating part 1082 into the collar 1072.

[0235] Next, referring to FIG. 28V, the plunger rod 1080 may be configured to translate distally relative to the flange piece 1070 to prime the delivery device 2400 until the bottom wall of the body 2432 touches the proximal end of the collar 1072. The removable cap 2430 may prevent the working part 1082 from being received within the collar 1072 by having at least a portion of the body 2342 disposed between the working part 1082 and the collar 1072. By engaging the body 2432 with the collar 1072 and translating the plunger rod 1080 from the proximal position (FIG. 28U) to the distal position (FIG. 28V), the delivery device 2400 may be in a primed position. It will be understood that the extent to which the plunger rod 1080 translates relative to the flange piece 1070 may correspond to the priming distance of the delivery device 2400. The priming distance may be controlled based on both or either of the size of the removable cap 2430 and the position of the removable cap 2430 relative to the plunger rod 1080. For example, in other embodiments, the bottom wall of the body 2432 may be fixed to the proximal portion of the stem 1081 disposed relatively distally of the working part 1082. In this example, the priming distance of the delivery device 2400 may be less than that described and explained herein because the body 2432 is disposed closer to the collar 1072. Thus, the plunger rod 1080 may need to move a lesser distance for the removable cap 2430 to touch the collar 1072.

[0236] As shown in FIG. 28X, the removable cap 2430 may be removed from the plunger rod 1080 such that the actuating portion 1082 is exposed from the body 2432. The plunger rod 1080 may be translated distally relative to the body 1060 and received within the collar 1072 in response to applying a distal force to the actuating portion 1082. The stem 1081 may move relative to the flange piece 1070 to move the stopper 1062 within the body 1060 in order to deliver a dose. It will be appreciated that the extent to which the plunger rod 1080 translates relative to the flange piece 1070 may correspond to the dose delivery distance of the delivery device 2400. The dose delivery distance may be controlled based on the attachment of the removable cap 2430 to both or either of the actuating portion 1082 and the stem 1081 as described above. Further, the depth of the collar 1072 may be a determining factor in the dose delivery distance such that the size of the collar 1072 is adjusted to form various appropriate dose delivery distances.

[0237] For example, by attaching the removable cap 2430 such that the distal wall of the removable cap 2430 is disposed at the same height relative to the distal end of the actuating portion 1082, the relative priming distance of the delivery device 2400 may be increased by separating the removable cap 2430 and the collar 1072 more greatly. Thus, the attachment position of the removable cap 2430 may correspond to a shorter dose delivery distance after translating the actuating portion 1082 into the collar 1072 after removal of the removable cap 2420. Alternatively, by attaching the removable cap 2430 such that the distal wall of the removable cap 2430 is disposed distal to the distal end of the actuating portion 1082, since the actuating portion 1082 requires further longitudinal translation to be fully received within the collar 1072, the relative priming distance may be reduced, thereby providing a longer dose delivery distance. It will be appreciated that the size and shape or the size or shape of the removable cap 2430 may vary to correspond to the various attachment positions described above.

[0238] In some embodiments, as shown in FIGS. 28W - 28Z, the delivery device 2400 may include one or more tabs 2440 fixed to the plunger rod 1080 along various other portions of, for example, the actuator 1082, the stem 1081, and / or the plunger rod 1080. In this example, the delivery device 2400 includes a pair of tabs 2440 extending radially outward from the distal end of the actuator 1082. The tabs 2440 may be obstacles and blocking components or obstacles or blocking components configured to increase the cross - sectional profile of the actuator 1082 to prevent movement of the plunger rod 1080 relative to the flange piece 1070, and more specifically to prevent translation of the actuator 1082 into the collar 1072. In some embodiments, the tabs 2440 may be selectively removable from the actuator 1082 after a force is applied to the tabs 2440. In other embodiments, the tabs 2440 may be pushable and may be configured to be pushed into the actuator 1082 in response to a force being applied to the tabs 2440. In either case, the tabs 2440 may be configured to shift the actuator 1082 from an extended profile (FIGS. 28W - 28Y) to a pushed - in profile (FIG. 28Z).

[0239] Referring now to FIG. 28Y, the plunger rod 1080 may be configured to translate distally relative to the flange piece 1070 to prime the delivery device 2400 until the tabs 2440 touch the proximal end of the collar 1072. The tabs 2440 may prevent the collar 1072 from receiving the actuator 1082 therein. By engaging the tabs 2440 with the collar 1072 and translating the plunger rod 1080 from a proximal position (FIG. 28W) to a distal position (FIG. 28Y), the delivery device 2400 may be in a primed position. It will be understood that the extent to which the plunger rod 1080 translates relative to the flange piece 1070 may correspond to the priming distance of the delivery device 2400.

[0240] The priming distance may be controlled based on both or either of the size of the tab 2440 (e.g., thickness, width, height, etc.) and the position of the tab 2440 relative to the plunger rod 1080. For example, in other embodiments, the pair of tabs 2440 may be fixed to both or either of the middle and proximal portions of the actuator 1082, or may be fixed along the stem 1081. In this example, the priming distance of the delivery device 2400 may be increased and / or decreased relative to those described and explained herein.

[0241] As seen in FIG. 28Z, the tab 2440 may be pushed into the actuator 1082 by applying an inward pressing force to the collar 1072 such that the actuator 1082 forms a smaller cross-sectional profile (alternatively, may be detached from the actuator 1082 by applying an outward pulling force, rotational snap force, etc.). The plunger rod 1080 may be translated distally relative to the body 1060 and received within the collar 1072 in response to a distal force being applied to the actuator 1082. The stem 1081 may move relative to the flange piece 1070 to move the stopper 1062 within the body 1060 in order to deliver a dose. It will be understood that the extent to which the plunger rod 1080 translates relative to the flange piece 1070 may correspond to the dose delivery distance of the delivery device 2400. As described above, the dose delivery distance may be controlled based on the position of the tab 2440 relative to the actuator 1082, the size of the collar 1072 (e.g., longitudinal depth), etc. For example, the relative position of the tab 2440 that increases the priming distance of the delivery device 2400 may correspond to a shorter dose delivery distance, and the position of the tab 2440 corresponding to a shortened priming distance may provide a longer dose delivery distance. In other examples, the plunger rod 1080 may include a second set of tabs (not shown) along the actuator 1082 that define the dose delivery distance based on the relative position of the tab relative to the tab 2440.

[0242] Figures 29A to 29C show an exemplary delivery device 2500 and a method of using the delivery device 2500. Since the delivery device 2500 includes substantially the same features as those shown and described above, the same reference numbers may be used to identify similar components. As shown in FIG. 29A, the delivery device 2500 may include a plunger rod 2580 including a first actuator 2502, a second actuator 2504, and a cam lever 2510. The first actuator 2502 may be connected to the second actuator 2504 by one or more arms 2506. In this example, a pair of arms 2506 may be fixed to the first actuator 2502 along a first end of the arms 2506, and the arms 2506 may be further connected to the second actuator 2504 at a second end of the arms 2506 opposite the first end. The second actuator 2504 may be a rotatable element including a proximal end 2505 and an opposing distal end having a joint 2508. The pair of arms 2506 may be connected to the distal end of the second actuator 2504 at the joint 2508.

[0243] When in the preparation position as seen in FIG. 29A, it will be understood that the second actuator 2504 may be oriented such that the joint 2508 is disposed proximal to the proximal end 2505 of the first actuator 2502. The proximal end 1088 of the stem 1081 may be disposed adjacent to the joint 2508 at the distal end of the second actuator 2504. For example, the proximal end 1088 may contact and abut or contact or abut against the distal end of the second actuator 2504. In some embodiments, the stem 1081 may extend through the center of the first actuator 2502 and be disposed alongside the first actuator 2502, or may extend through the center of the first actuator 2502 or be disposed alongside the first actuator 2502. The second actuator 2504 may be configured to move around the joint 2508 relative to the first actuator 2502. The cam lever 2510 may be coupled to the second actuator 2504 at the joint 2508 and may be configured to move (e.g., rotate, pivot, translate, etc.) the second actuator 2504 relative to the first actuator 2502. Thus, it will be understood that the second actuator 2504 may be configured to move the stem 1081 relative to the body 1060 in response to the cam lever 2510 moving the second actuator 2504 relative to the first actuator 2502.

[0244] For example, referring to FIG. 29A, the cam lever 2510 may be actuated by rotating the cam lever 2510 around the joint 2508, thereby rotating the second actuating part 2504 around the joint 2508. The proximal end 2505 may be moved toward the first actuating part 2502 as the second actuating part 2504 rotates around the joint 2508. In this example, the proximal end 2505 may be moved toward the first actuating part 2502. When the proximal end 2505 is moved from the proximal position (FIG. 29A) to the distal position (FIG. 29B), the proximal end 1088 is pushed distally, thereby translating the stem 1081 relative to the body 1060 to prime the delivery device 2500. In other words, rotation of either or both of the first actuating part 2502 and the second actuating part 2504 relative to the cam lever 2510 may prime the delivery device 2500 by pushing the stem 1081 distally.

[0245] It will be appreciated that the travel length of the proximal end 2505 toward the first actuating part 2502 may correspond to the priming distance of the delivery device 2500. In other words, the priming distance of the delivery device 2500 may be controlled by the longitudinal length of the second actuating part 2504 between the proximal end 2505 and the joint 2508. In some embodiments, the first actuating part 2502, the arm 2506, and / or the cam lever 2510 may be intended to prevent further rotation of the second actuating part 2504 after the plunger rod 2580 has moved from the ready position (FIG. 29A) to the primed position (FIG. 29B).

[0246] As shown in FIG. 29C, the plunger rod 2580 may be translated distally relative to the body 1060 in response to applying a distal force to the first actuator 2502 and the second actuator 2504. In this example, the cam lever 2510 may move the first actuator 2502 and the second actuator 2504 toward the flange piece 1070 by pushing distally (e.g., pushing and / or pulling) until it touches the proximal end of the collar 1072. The stem 1081 may move the stopper 1062 within the body 1060 by moving relative to the collar 1072 to deliver a dose. It will be appreciated that the degree of translation of the plunger rod 2580 relative to the flange piece 1070 may correspond to the dose delivery distance of the delivery device 2500. The dose delivery distance may be controlled based on the gap formed between the collar 1072 and the cam lever 2510.

[0247] FIGS. 30 - 31 show an exemplary delivery device 2600 that may include substantially the same features as those shown and described above, and thus like reference numerals may be used to identify like components. The delivery device 2600 may include a flange piece 2670, a plunger rod 2680, and a body 1220. The flange piece 2670 may include a tapered collar 2672 having various sizes and shapes or sizes or shapes between a distal end and a proximal end. In this example, the tapered collar 2672 may have a larger cross-sectional profile (e.g., diameter) along the distal end adjacent to the flange 1076 than at the proximal end adjacent to the slot 1074. The tapered collar 2672 may be configured to minimize the overall profile and weight or profile or weight of the delivery device 2600 by minimizing the configuration of the flange piece 2670. In some embodiments, the flange 1076 may have a shortened length to facilitate control and operability of the flange piece 2670.

[0248] The plunger rod 2680 may include an actuating portion 2682 having a relatively small cross-sectional profile (e.g., diameter) compared to the tapered collar 2672 to facilitate reception of the actuating portion 2682 therethrough. Thus, the actuating portion 2682 may be similarly configured to minimize the overall profile and weight or the profile or weight of the delivery device 2600 by minimizing the configuration of the actuating portion 2682. Further, the plunger rod 2680 may omit texturing and ribbed surfaces or incorporation of texturing and ribbed surfaces along the actuating portion 2682 to simplify the appearance of the plunger rod 2680.

[0249] Referring particularly to FIG. 30, the actuating portion 2682 may further include a proximal end having an outer ring 2687, an inner surface 2688, and one or more openings 2689 formed through the inner surface 2688. In this example, the inner surface 2688 may be disposed within the outer ring 2687 and may have an angled profile that slopes radially inwardly toward the one or more openings 2689. The inner surface 2688 may be configured to define an interface for actuating the plunger rod 2680 (e.g., applying a distal force to the actuating portion 2682 by a user's finger). Although the plunger rod 2680 is shown including a pair of openings 2689, it will be understood that in other embodiments, more and / or fewer openings 2689 may be included on the inner surface 2688.

[0250] In some embodiments, as seen in FIG. 31, the plunger rod 2680 may include an outer ring 2687' having a width that defines an outer surface disposed about an inner surface 2688. For example, the outer surface of the outer ring 2687' may be angled inwardly toward the inner surface 2688 and the opening 2689 and be transverse to the inner surface 2688, or may be angled inwardly toward the inner surface 2688 and the opening 2689 or be transverse to the inner surface 2688. In this example, the outer ring 2687' defines a planar outer surface that is substantially perpendicular to the longitudinal length of the actuator 2682. The enlarged width of the outer ring 2687' may provide additional surface area for a user to contact the device 1050 when actuating the plunger rod 2680. It will be understood that the width of the outer ring 2687' may be larger and / or smaller than that described and illustrated herein without departing from the scope of the present disclosure.

[0251] Figures 32-33 illustrate an exemplary plunger rod 2780 that may include substantially the same features as the plunger rod 1080 shown and described above, and thus like reference numerals may be used to identify like components. The plunger rod 2780 may include an actuating portion 2782 having a proximal end defined by an outer ring 2787, an inner ring 2788, and one or more openings 2789. In this example, the inner ring 2788 may be disposed within the outer ring 2787 and may define at least one opening 2789. The outer ring 2787 may further define at least one opening 2789 disposed radially outward of the inner ring 2788. One or more of the openings 2789 may minimize the overall weight of the plunger rod 2780, such as by providing a thin walled actuating portion 2782, and may enhance the ability to mold and manufacture the plunger rod 2780. Further, the actuating portion 2782 may include a side ledge 2786 that extends across the width of the distal end and is aligned with the protrusion 1086. The side ledge 2786 may bifurcate one or more of the openings 2789 defined by the outer ring 2787 and the inner ring 2788. The side ledge 2786 may be collinear with the protrusion 1086 to provide either or both visual alignment and identification of the protrusion 1086 to a user of the plunger rod 2780.

[0252] As seen in FIG. 33, when the plunger rod 2780 is received within the flange piece 1070 and the body 1220, the side ledge 2786 may be configured to enhance the identification of movement of the plunger rod 2780 relative to the flange piece 1070 from a proximal perspective of the device 1200. For example, the side ledge 2786 may facilitate identifying the relative position of the protrusion 1086 relative to the slot 1074 from a proximal perspective of the actuating portion 2782 during use of the device 1200. In some embodiments, the plunger rod 2780 may omit textured and ribbed surfaces or textured or ribbed surfaces along the actuating portion 2782 to simplify the appearance of the plunger rod 2780.

[0253] FIG. 34 shows another exemplary delivery device 2800 according to an example of the present disclosure. Since the delivery device 2800 includes substantially the same features as the delivery devices 1050 and 1200 shown and described above, the same reference numbers may be used to identify similar components. The delivery device 2800 may include a flange piece 2870, a plunger rod 2880, and a body 1220. The flange piece 2870 may have a collar 2872 and a pair of flanges 2876 extending laterally outward from the collar 2872. The collar 2872 may have, for example, a narrower profile than the collar 1072. Further, the flange 2876 may have a shorter length than the flange 1076. Thus, the flange piece 2870 of this example may generally have a narrower profile. The flange piece 2870 may further include a lip 2871 that slides under or otherwise receives the body flange 1226 (FIG. 35). The lip 2871 may be configured to hold the flange piece 2870 in place by slidably connecting the flange piece 2870 to the body 1220. As will be described in more detail below, the lip 2871 may be made of a flexible or semi-flexible material capable of forming a snap-fit connection with the body flange 1226.

[0254] The plunger rod 2880 may include an actuating portion 2882 having one or more protrusions 1086 along the proximal end and one or more extensions 1087 along the distal end. The actuating portion 2882 may have a generally smaller diameter than the actuating portion 1082 shown and described above. Thus, it will be understood that the plunger rod 2880 and the flange piece 2870 may form a generally narrower profile as a whole with respect to the assembly of the plunger rod 1080 and the flange piece 1070. By providing a reduced profile, the delivery device 2800 may be configured to provide the user with improved control and operability of the plunger rod 2880 and the flange piece 2870 during use of the delivery device 2800.

[0255] In this embodiment, the protrusion 1086 may have a curvature configured to enhance the gripping, comfort, and / or ergonomics of the plunger rod 2880 for the user of the delivery device 2800. The curvature of the protrusion 1086 may have a concave outer configuration that tapers inwardly along the distal portion of the protrusion. The proximal end of the actuator 2882 may further include a first ring 2887, an opening 2888, and a second ring 2889 disposed distal to the first ring 2887. The first ring 2887 may define the proximal interface of the actuator 2882, and the opening 2888 may be disposed at the center of the first ring 2887. The proximal interface defined by the first ring 2887 may be angled toward the opening 2888 such that the proximal end of the actuator 2882 slopes radially inwardly. In some embodiments, the first ring 2887 may be sized, shaped, and configured to facilitate actuation of the plunger rod 2880 by defining a finger pad for receiving the user's finger. The opening 2888 may be configured to maintain a slight wall thickness of the actuator 2882 to facilitate shaping of the plunger rod 2880 during the manufacturing process of the delivery device 2800. The opening 2888 may further minimize the overall weight of the plunger rod 2880.

[0256] Continuing to refer to FIG. 34, the second ring 2889 may extend radially outward from the outer surface of the actuating portion 2882 and may be disposed adjacent to the first ring 2887. The second ring 2889 may be configured to form a grippable feature along the actuating portion 2882, for example, to enhance the control of the plunger rod 2880 when rotating the plunger rod 2880. The first ring 2887 may have a diameter larger than that of the actuating portion 2882 such that the finger pad formed by the first ring 2887 has a cross-sectional profile larger than that of the actuating portion 2882. In some embodiments, the second ring 2889 may be larger than the actuating portion 2882 and may include a diameter substantially similar to that of the first ring 2887. The plunger rod 2880 may omit textured machining and ribbed surfaces or the incorporation of textured or ribbed surfaces along the actuating portion 2882 to simplify the appearance of the plunger rod 2880.

[0257] As shown in FIG. 35, the actuating part 2882 may be sized to have a predetermined length C between the distal end of the protrusion 1086 and the hook or clip-shaped portion 1087a of the extension 1087. In some embodiments, the predetermined length C may be sized according to the type and size of the syringe cap used in the delivery device 2800 (e.g., Alba ITC of Ompi, Alba OVS of Ompi, TELC of Gerresheimer, silicone-free syringe, etc.) or according to the type or size. For example, the predetermined length C may be decreased and / or increased according to the requirements for lower and / or higher filling volumes, respectively determined based on the syringe cap. Further, the predetermined length C may be sized to provide the full stroke of the plunger rod 2880 within the flange piece 2870 to ensure that the full dose is delivered by the delivery device 2800. The predetermined length C may be further adjusted to provide one of a plurality of appropriate dose delivery distances for the delivery device 2800. The flange piece 2870 may include additional features and components or features or components configured to allow the full stroke of the plunger rod 2880.

[0258] For example, referring next to FIG. 36, the flange piece 2870 may include one or more depressions 2875 formed along a (bottom) surface that faces proximally and is located distally to the collar 2872. The depression 2875 may be sized and shaped or sized or shaped to form a concave surface on the bottom surface of the collar 2872. The depression 2875 may be configured to facilitate receiving the plunger rod 2880 within the flange piece 2870 to allow for the full stroke. In other words, the depression 2875 may provide increased space and clearance or space or clearance within the collar 2872 to receive one or more components of the plunger rod 2880, such as the hook or clip-shaped portion 1087a of the extension 1087.

[0259] In this example, the delivery device 2800 may be configured to deliver the full dose after a pair of protrusions 1086 contact the distal end (bottom) of the slot 1074. The pair of extensions 1087 may be disposed adjacent to (but not in contact with) the bottom surface of the collar 2872 when the protrusions 1086 contact the distal end of the slot 1074. That is, in some embodiments, the extensions 1087 may be disposed proximal to the bottom surface of the collar 2872 such that the extensions 1087 do not contact the bottom surface when the plunger rod 2880 reaches the bottom, and when the full dose is delivered from the delivery device 2800, or at any time therebetween. By forming a recess along the bottom surface of the collar 2872, the recess 2875 may allow the actuating portion 2882 to translate distally relative to the collar 2872 in order for the extensions 1087 to complete the full stroke of the plunger rod 2880 without engaging or contacting the bottom surface of the collar 2872. In some embodiments, the extensions 1087 may bend inwardly toward the recess 2875 after a hook or clip-shaped portion 1087a contacts the bottom surface of the collar 2872, thereby guiding the hook or clip-shaped portion 1087a into the recess 2875. It will be understood that the increased space formed by the recess 2875 may ensure that the extensions 1087 are not prevented from contacting the bottom surface of the collar 2872 in order to complete the full stroke of the plunger rod 2880, and / or to deliver the full dose, or for any of these purposes.

[0260] Continuing to refer to FIG. 36, the flange piece 2870 may further include one or more ribs 2874 configured to engage the body flange 1226 when the body 1220 is coupled to the flange piece 2870. The one or more ribs 2874 may be disposed adjacent to the lip 2871, for example, at the distal end of the bottom surface of the collar 2872 and the proximal end of the lip 2871. In some embodiments, the rib 2874 may extend radially inwardly from the inner sidewall of the flange piece 2870, while in other embodiments, the rib 2874 may extend outwardly from the inner top wall of the flange piece 2870. In this example, the rib 2874 may extend obliquely radially inwardly with respect to the inner sidewall of the flange piece 2870. It will be understood that the rib 2874 may be arranged and extend or be arranged or extend at various other suitable angles from various other suitable positions within the flange piece 2870 to engage the body flange 1226.

[0261] In this embodiment, the rib 2876 may be formed of both or either a flexible material and a semi-flexible material (such as plastic, rubber, etc.), and may be configured to interact with the body flange 1226 after the body 1220 is received within the flange piece 2870. As an exemplary example, the rib 2874 may be configured to bend proximally or bend or turn toward the bottom surface of the collar 2872 in response to the reception of the body flange 1226 by the lip 2871. The rib 2874 may be usable to secure the body flange 1226 to the flange piece 2870 by applying a distal-directed force to the rib 2874. Thus, the rib 2874 may fix the position (such as the longitudinal position, rotational position, etc.) of the body 1220 relative to the flange piece 2870 by engaging the upper / proximal surface of the body flange 1226 when the lip 2871 engages the bottom surface of the body flange 1226. In other embodiments, more and / or fewer ribs 2874 may be included to prevent movement of both or either the body flange 1226 and the body 1220 relative to the flange piece 2870.

[0262] Next, referring to FIG. 37, the flange piece 2870 may include a textured and patterned or textured or patterned interface 2878 along the distal facing surface at the bottom of the flange 2876. The textured interface 2878 may include one or more protrusions, indentations, and / or various other features that form at least one of a plurality of patterns to enhance the gripping, control, and / or ergonomics of the flange piece 2870. In this example, the textured interface 2878 includes a plurality of semi-circular protrusions of various sizes. As shown in FIG. 37, each interface 2878 may be concave when viewed from the radial center of the flange 2876. However, in an alternative embodiment, one or more interfaces 2878 may be convex when viewed from the radial center of the flange 2876. As will be described in more detail below, the textured interface 2878 may include various other designs, features, and / or patterns along the bottom surface of the flange 2876 (see FIGS. 41A-41D). The flange piece 2870 may further include a pair of movable tabs 2877 adjacent to the lip 2871 and disposed along the opposing side surfaces of the opening 1073. The movable tabs 2877 may be formed of either or both flexible and semi-flexible materials and may be configured to move relative to both or either of the collar 2872 and the flange 2876 in response to a force applied to the movable tabs 2877 (e.g., by the body 1220).

[0263] Each movable tab 2877 may define an opening 2873 disposed between the movable tab 2877 and the flange 2876. Thus, the movable tab 2877 may be separated from the flange 2876 by the opening 2873 formed therebetween. The opening 2873 may provide a gap and gap space or a gap or gap space for accommodating lateral movement of the movable tab 2877 after receiving a radially outward force. For example, the movable tab 2877 may flex radially outward toward the flange 2876 as the flange piece 2870 receives the body 1220 through the opening 1073, thereby changing the size and shape or the size or shape of the opening 2873. In this example, the movable tab 2877 may bend outward away from the opening 1073 until the body flange 1226 is received by the lip 2871. The movable tab 2877 may be configured to bend inward toward the body 1220 to return to its original configuration after the lip 2871 fully receives the body flange 1226 therein. In some embodiments, the movable tab 2877 may bend substantially back to its original configuration toward the body 1220 so that the movable tab 2877 remains at least partially pushed into the body 1220 to prevent slippage by preventing movement of the body 1220 relative to the flange piece 2870 and continuously applying pressure to the body 1220.

[0264] Continuing to refer to FIG. 37, the movable tab 2877 may be configured to apply a radially inward force to the body 1220 (biased with a radially inwardly directed material), thereby forming a snap-fit connection between the flange piece 2870 and the body 1220. Further, the movable tab 2877 may maintain the body 1220 in a stabilized and fixed position relative to the flange piece 2870, thereby connecting the flange piece 2870 to the body 1220. It will be appreciated that an opening 2873 may be included between the movable tab 2877 and the flange 2876 to reduce the force required to connect the body 1200 to the flange piece 2870. For example, the opening 2873 may be used to reduce the force required to snap the body 1200 into the flange piece 2870 to a minimum force in the range of about 15 Newtons to about 25 Newtons compared to a design that omits the opening 2873.

[0265] FIGS. 38A-40C illustrate a method of using an exemplary delivery device 2800. As seen in FIG. 38A, the delivery device 2800 may receive the distal portion of the actuator 2882 within the collar 2872 and receive and connect the extension 1087 within the opening 1094 for pre-assembly. It will be appreciated that by connecting the extension 1087 to the collar 2872 via the opening 1094, the flange piece 2870 may prevent proximal retraction of the actuator 2882. Thus, the plunger rod 2880 may be prevented from disengaging from the flange piece 2870. In this example, the delivery device 2800 may be primed by translating the plunger rod 2880 distally into the flange piece 2870.

[0266] As shown in FIG. 38B, the actuating portion 2882 may be translated distally relative to the flange piece 2870 until the projection 1086 touches the proximal end of the collar 2872. The plunger rod 2880 may complete the priming process of the delivery device 2800 after the projection engages and abuts or engages or abuts the collar 2872. It will be understood that the extent to which the plunger rod 2880 translates distally relative to the flange piece 2870 may correspond to the priming distance of the delivery device 2800. The priming distance may be controlled based on the longitudinal length of both or one of the projection 1086 and the extension 1087, thereby changing the relative distance between the proximal end of the collar 2872 and the distal end of the projection 1086.

[0267] As shown in FIG. 38C, the flange piece 2870 may be rotated relative to the plunger rod 2880 to move the projection 1086 relative to the collar 2872 until it reaches radial and longitudinal alignment with the slot 1074, and vice versa. Referring to FIGS. 39A - 39B, the extension 1087 may contact the inner surface 2872A of the collar 2872 as the plunger rod 2880 rotates relative to the flange piece 2870. As seen in FIG. 39D, while engaging the hook or clip-shaped portion 1087a with the inner surface 2872A, the extension 1087 may be deflected radially inward by the collar 2872 until the plunger rod 2880 is rotated and the extension 1087 and the inner groove 2879 of the flange piece 2870 are aligned. The inner groove 2879 may define a recess formed along the inner surface 2872A. As seen in FIGS. 39C and 39E, the inner groove 2879 may be sized and shaped to receive the extension 1087 therein. It will be understood that the collar 2872 may have a larger diameter in the inner groove 2879 than along the inner surface 2872A such that the extension 1087 expands radially outward from a retracted configuration (FIGS. 39A - 39B and 39D) to an expanded configuration (FIGS. 39C and 39E) as the extension 1087 moves into radial alignment with the inner groove 2879.

[0268] In other words, as seen in FIG. 39E, the extension portion 1087 may transition to a relaxed state when received within the internal groove 2879 by the additional space provided by the internal groove 2879. In some examples, feedback (e.g., tactile, auditory, etc.) may be generated in response to the extension portion 1087 being received within the internal groove 2879. The delivery device 2800 may be arranged in a dose delivery state such that further actuation of the plunger rod 2880 provides dose delivery. In some embodiments, the flange piece 2870 may be used to generate user feedback (e.g., tactile, audible, etc.) after rotating the plunger rod 2880 relative to the flange piece 2870 to prime the delivery device 2800.

[0269] As described in detail above and as seen in FIGS. 40A - 40C, the opening 1073 may have a semi - circular shape with one or more edges 2873 extending within the opening 1073. The stem 1280 may be received through the opening 1073 while connecting the plunger rod 2880 to the flange piece 2870. The stem 1280 may include a rounded sidewall 2884 configured to interact with one or more edges 2873 as the plunger rod 2880 rotates relative to the collar 2872. For example, the rounded sidewall 2884 may define a semi - circular end along the stem 1280 that contacts the edge 2873 when the plunger rod 2880 moves from the primed position (FIG. 38B) to the dose delivery position (FIG. 38C). As detailed above (FIGS. 4K - 4X), it will be understood that the stem 1280 may have various suitable shapes and configurations or shapes or configurations to facilitate movement (e.g., rotation) of t...

Claims

1. A drug delivery device comprising: a body; a plunger rod partially disposed within the body; a protrusion extending from the plunger rod; and a blocking component coupled to a proximal end of the body, wherein the blocking component is a flange piece, and when the protrusion is in a first position relative to the blocking component, the blocking component restricts distal movement of the plunger rod to a first stop point, and when the protrusion is in a second position relative to the blocking component, the blocking component restricts distal movement of the plunger rod to a second stop point.

2. The drug delivery device according to claim 1, further comprising: a stopper disposed within the body, the stopper being displaced distally by distal movement of the plunger rod; and a drug substance disposed between the stopper and a distal end of the body within the body. Distal movement of the plunger rod to the first stop point primes the drug delivery device, and distal movement of the plunger rod to the second stop point dispenses a predetermined volume of the drug substance from a distal end of the drug delivery device.

3. The drug delivery device according to claim 1, wherein moving the protrusion from the first position to the second position includes turning the plunger rod relative to the blocking component.

4. The drug delivery device according to claim 1, further comprising: a cavity on a proximal side of the blocking component, the cavity being sized to receive a portion of the protrusion, wherein when the protrusion is in the second position relative to the blocking component, the protrusion is disposed proximal to the cavity such that distal movement of the plunger rod moves the protrusion into the cavity.

5. The drug delivery device according to claim 4, wherein the cavity is a first cavity, and the drug delivery device further comprises: a second cavity on a proximal side of the blocking component, the second cavity being sized to receive a portion of the protrusion, wherein the first cavity and the second cavity are located on opposite sides of a longitudinal central axis of the drug delivery device.

6. The drug delivery device according to claim 1, wherein the plunger rod passes through an opening of the blocking component.

7. The drug delivery device according to claim 1 further comprises an actuating part at the proximal end of the plunger rod, wherein the protrusion extends from the actuating part, a drug delivery device. **Claim 8** The drug delivery device according to claim 7, wherein the actuating part has a generally cylindrical shape with a diameter exceeding the width of the remaining part of the plunger rod, the protrusion extends from the generally cylindrical side, and the actuating part further comprises a thumb pad located at the proximal end of the actuating part, and a ring located on the outer surface of the side of the generally cylindrical shape comprising a drug delivery device. **Claim 9** The drug delivery device according to claim 7 further comprises a proximal collar on the blocking component, and the actuating part is partially fitted inside the proximal collar, a drug delivery device. **Claim 10** The drug delivery device according to claim 7, wherein the plunger rod further comprises a pair of extensions protruding distally from the actuating part, and the blocking component comprises a pair of openings, wherein a part of each extension is configured to be received by one of the pair of openings at the first stop point, a drug delivery device. **Claim 11** The drug delivery device according to claim 10, wherein the blocking component comprises one or more depressions formed along the bottom wall of the blocking component, wherein a part of each extension is configured to be received by the one or more depressions after distal movement of the plunger rod relative to the blocking component to enable distal movement of the plunger rod to the second stop point, a drug delivery device. **Claim 12** The drug delivery device according to claim 10, wherein the blocking component comprises a pair of internal grooves formed along the side wall of the blocking component, wherein a part of each extension is received by at least one of the pair of internal grooves after rotation of the plunger rod relative to the blocking component, and the extension is configured to expand radially outward from a pushed-in state to a relaxed state, a drug delivery device. **Claim 13** The drug delivery device according to claim 1, wherein the protrusion is a first protrusion, and the drug delivery device further comprises a second protrusion extending from the plunger rod in a direction opposite to the first protrusion, a drug delivery device. **Claim 14** The drug delivery device according to claim 1, wherein the blocking component is slidably coupled to the main body and includes a third cavity and a pair of ribs extending into the third cavity, the main body includes an upper flange, and the pair of ribs are configured to engage with the upper flange received in the third cavity. A drug delivery device, wherein the pair of internal ribs are configured to apply a distal force to the upper flange.

15. The drug delivery device according to claim 1, wherein the blocking component is slidably coupled to the main body and includes a pair of movable tabs configured to engage with the main body. A drug delivery device, wherein the pair of movable tabs are deflectable laterally after receiving the sleeve into the blocking component and are configured to apply a radial force to the sleeve.

16. The drug delivery device according to claim 1, wherein the blocking component further includes a pair of finger flanges. A drug delivery device, wherein each of the finger flanges includes a textured surface having a predetermined pattern for improving the gripping force of the blocking component.

17. A drug delivery device, comprising: a main body; a plunger rod having a proximal end including an operating portion with a distal end contacting a stopper inside the main body and a thumb pad; a plurality of protrusions extending from the operating portion; a blocking component disposed on the main body, the blocking component including a proximal collar having a plurality of slots; and when the protrusions and the slots are in a first configuration relative to each other, the blocking component restricts distal movement of the plunger rod to a first stop point, and when the protrusions and the slots are in a second configuration, the blocking component restricts distal movement of the plunger rod to a second stop point. A drug delivery device, wherein in the second configuration, the slots are configured to receive the protrusions after distal movement of the plunger rod.

18. The drug delivery device according to claim 17, wherein the protrusions and the slots are movable from the first configuration to the second configuration by rotation of the operating portion about the longitudinal axis with respect to the blocking component, and when the protrusions and the slots are in the second configuration, the protrusions and the slots do not move to the first configuration.

19. The difference between the first stop point and the second stop point is equal to the distance that the stopper has to move in order to discharge a predetermined volume of pharmaceutical from the distal end of the body, and movement of the plunger rod from the second stop point to the first stop point is restricted, the drug delivery device according to claim 17.

20. The plurality of protrusions includes two protrusions symmetrically arranged around the actuating part, the drug delivery device according to claim 17.

21. The blocking component further includes a pair of finger flanges, the drug delivery device according to claim 17.

22. The drug delivery device is a prefilled syringe, the drug delivery device according to claim 17.

23. A drug delivery device according to claim 17, the drug delivery device comprising: (a) convertible from a pre-use state to a primed state by longitudinally moving the plunger rod until the plunger rod reaches the first stop point; (b) convertible from a primed state to a delivery state by rotating the plunger rod relative to the blocking component until the protrusion and the blocking component are in the second configuration; (c) convertible from a delivery state to a used state by longitudinally moving the plunger rod until the plunger rod reaches the second stop point; The drug delivery device is non-convertible from the used state to the delivery state, non-convertible from the delivery state to the primed state, or non-convertible from the primed state to the pre-use state, a drug delivery device.

24. The plunger rod includes a neck disposed distally of the actuating part, the neck interfacing with an opening of the blocking component to prevent proximal movement of the plunger rod, the drug delivery device according to claim 23.

25. The neck further interfaces with the opening of the blocking component to prevent movement of the drug delivery device from the delivery state to the primed state, the drug delivery device according to claim 24.

26. When the plunger rod is at the second stop point, the stopper does not contact the distal end of the body, the drug delivery device according to claim 17.

27. A drug delivery device, comprising: a body, A plunger, a distal portion that contacts a stopper within the body, a proximal end including a generally cylindrical actuating portion disposed outside the body, and two projections extending from opposite sides of the actuating portion in a symmetrical configuration comprising a plunger, a blocking component coupled to the body comprising, the blocking component including: a collar configured to receive a distal portion of the actuating portion, two cavities within the collar having openings facing proximally each cavity being configured to receive a distal portion of one of the two projections, the plunger rod being movable longitudinally and rotatable about a longitudinal axis relative to the blocking component, wherein when the drug delivery device is in a pre-use state, the projections and the openings of the cavities are not longitudinally aligned, and when the drug delivery device is in a delivery state, the projections and the openings of the cavities are longitudinally aligned. A drug delivery device. **Claim 28** The drug delivery device according to claim 27, wherein the blocking component further includes a finger flange, the drug delivery device further including a ribbed surface on a side surface of the actuating portion. **Claim 29** The drug delivery device according to claim 27, wherein the plunger further includes: two extensions protruding distally from the actuating portion, and a plurality of openings within the collar of the blocking component comprising, wherein a portion of each extension is configured to be received within the plurality of openings after distal movement of the plunger rod relative to the blocking component. A drug delivery device. **Claim 30** A method of dispensing a substance from a drug delivery device having a plunger rod and a body, the method comprising: (a) advancing the plunger rod a predetermined distance into the body until advancement of the plunger rod is resisted by a stop; (b) rotating the plunger rod about a longitudinal axis; and (c) actuating the plunger rod to dispense a predetermined volume of the substance, wherein none of steps (a), (b), and (c) are reversible. **Claim 31** The method according to claim 30, wherein the drug delivery device further includes a flange piece having a collar, and actuating the plunger rod includes pushing an actuating portion of the plunger rod into the collar of the flange piece. **Claim 32** The method according to claim 31, wherein the plunger rod includes a protrusion, and the collar of the flange piece abuts against the protrusion so as to resist the forward movement of the plunger rod.

33. The method according to claim 31, wherein rotating the plunger rod includes screwing an operating portion of the plunger rod with respect to the flange piece until a protrusion on the plunger rod is longitudinally aligned with a cavity of the collar of the flange piece.

34. The method according to claim 33, further comprising: advancing the protrusion into the cavity until the protrusion abuts against a distal side of the cavity, and dispensing a predetermined volume of a substance when the protrusion abuts against the distal side of the cavity.

35. A drug delivery device, comprising: a body; a stopper disposed within the body; a sleeve having a proximal end and a distal end, the distal end being disposed inside the body proximal to the stopper; a plunger rod disposed at least partially inside the sleeve; wherein when the stopper is in a ready position, any one of (a) only the sleeve, (b) only the plunger rod, or (c) both the sleeve and the plunger rod advancing distally with respect to the body advances the stopper to a primed position; and when the stopper is in the primed position, any other distal advancement of (a) only the sleeve, (b) only the plunger rod, or (c) both the sleeve and the plunger rod together with respect to the body advances the stopper to a dose delivered position.

36. The drug delivery device according to claim 35 further comprises: a removable blocking component disposed between a proximal portion of the sleeve and a proximal end of the body, the blocking component preventing distal advancement of the sleeve of the body; and distal advancement of the sleeve with respect to the body after removing the blocking component advances the stopper to a primed position.

37. The drug delivery device according to claim 36, wherein the blocking component is a clip removably fixed around at least a portion of the sleeve.

38. The drug delivery device according to claim 35 further comprises: ​ comprising a removable locking component for connecting the plunger rod to the sleeve, wherein distal advancement of both the sleeve and the plunger rod together relative to the body advances the stopper to the primed position, and distal advancement of only the plunger rod relative to the body after removal of the locking component advances the stopper to the administration completed position, a drug delivery device.

39. The drug delivery device according to claim 38, wherein at the administration completed position, the proximal end of the plunger rod abuts against the distal end of the sleeve so as to prevent further distal advancement of the plunger rod relative to the body.

40. The drug delivery device according to claim 38, wherein the removable locking component includes one of a pin, a tab, and a bar.

41. The drug delivery device according to claim 35 further comprises a protrusion disposed on the plunger rod, and an internal protrusion disposed on an inner wall of the sleeve distal to the protrusion of the plunger rod, wherein distal advancement of only the plunger rod relative to the body advances the stopper to the primed position and brings the protrusion of the plunger rod into contact with the internal protrusion of the sleeve, and distal advancement of both the plunger rod and the sleeve relative to the body advances the stopper to the administration completed position after the protrusion of the plunger rod has contacted the internal protrusion of the sleeve, a drug delivery device.

42. The drug delivery device according to claim 35, wherein the sleeve includes a finger flange.

43. The drug delivery device according to claim 35 further comprises a stop disposed at the proximal end of the body, the stop being sized to prevent distal advancement of the sleeve or the plunger rod when the stopper reaches the completed position, a drug delivery device.

44. A drug delivery device, comprising a body, a plunger rod having a distal portion disposed inside the body and a proximal portion disposed outside the proximal end of the body, the proximal portion having a width greater than the width of the distal portion, and an obstacle at an obstacle position for the plunger rod to prevent distal advancement of the plunger rod from the primed position to the administration completed position.

24. ​ A drug delivery device in which movement of the obstacle from the obstacle position enables distal advancement of the plunger rod to the administration completion position.

45. The drug delivery device according to claim 44 further comprises a collar fixed to the distal end of the body, the collar surrounding the proximal portion of the plunger rod, and a collar protrusion extending radially inward from the collar and comprises the proximal portion of the plunger rod includes a channel into which the collar protrusion projects, the channel including a circumferential path and an axial administration completion path, the obstacle includes a collar protrusion that prevents distal advancement of the plunger rod to the administration completion position when disposed within the circumferential path of the channel, movement of the obstacle from the obstacle position includes twisting the plunger rod about its longitudinal axis so as to align the collar protrusion with the axial administration completion path, a drug delivery device.

46. The drug delivery device according to claim 45, wherein the channel further includes an axial priming path offset from the axial administration completion path and connected to the axial administration completion path by the circumferential path, distal movement of the plunger rod such that the collar protrusion moves within the axial priming path advances the plunger rod to a primed position, a drug delivery device.

47. The drug delivery device according to claim 45, wherein the collar further includes a finger flange.

48. The drug delivery device according to claim 44, wherein the proximal portion of the plunger rod includes a protrusion extending radially outward, the drug delivery device further comprises a rotatable alignment component disposed between the proximal portion of the plunger rod and the body, the alignment component being sized to receive the protrusion of the plunger rod and includes a channel configured to the obstacle includes a wall of the channel that blocks the distal axial path of the protrusion of the plunger rod when the plunger rod is in the primed position, movement of the obstacle from the obstacle position includes rotating the alignment component to remove the wall of the channel from the distal axial path of the protrusion of the plunger rod, a drug delivery device.

49. The drug delivery device according to claim 48 further comprises including a finger flange connected to the proximal end of the body; The rotatable alignment component is a drug delivery device disposed between the finger flange and the proximal portion of the plunger rod. **Claim 50** The drug delivery device according to claim 44 further includes including a flange piece disposed at the proximal end of the body, The obstacle includes a removable cap that is partially disposed between the proximal portion of the plunger rod and the flange piece when the obstacle is at the obstacle position relative to the plunger rod. The drug delivery device. **Claim 51** The drug delivery device according to claim 50, wherein by removing the cap, the proximal portion of the plunger rod can be advanced to the administration complete position, At the administration complete position, the proximal portion of the plunger rod contacts the flange piece. The drug delivery device. **Claim 52** The drug delivery device according to claim 50, wherein the removable cap closes the proximal portion of the plunger rod when at the obstacle position. The drug delivery device. **Claim 53** The drug delivery device according to claim 44 further includes a collar disposed between the proximal end of the body and the proximal portion of the plunger rod, the collar defining an opening sized to receive the proximal portion of the plunger rod after distal advancement of the plunger rod beyond the primed position, The obstacle includes a tab that projects radially outward from the proximal portion of the plunger rod and prevents the proximal portion of the plunger rod from fitting into the opening of the collar. The depth of the opening of the collar corresponds to the distance that the plunger rod must move distally to the administration complete position. The drug delivery device. **Claim 54** The movement of the obstacle from the obstacle position includes removing the tab or pushing the tab into the side of the proximal portion of the plunger rod. The drug delivery device according to claim 53. **Claim 55** The tab is a first tab, and the obstacle further includes a second tab that projects radially outward from the proximal portion of the plunger rod in a direction opposite to the protruding direction of the first tab. The drug delivery device according to claim 53. **Claim 56** The drug delivery device according to claim 53, wherein the obstacle includes a tab disposed between the body and the proximal portion of the plunger rod when the obstacle is at the obstacle position, The plunger rod has a geometric shape disposed proximal to the tab, and the geometric shape cannot advance distally beyond the tab when the tab is at the obstacle position. A drug delivery device.

57. The drug delivery device according to claim 56, wherein the movement of the obstacle includes removing the tab from the drug delivery device by pulling the tab.

58. The drug delivery device according to claim 56 further comprises a flange piece, A drug delivery device in which a part of the tab is disposed inside the cavity of the flange piece.

59. The drug delivery device according to claim 56, wherein the movement of the obstacle includes removing the tab from the drug delivery device by breaking the tab.

60. The drug delivery device according to claim 54, wherein the obstacle is disposed proximal to the proximal end of the body between the proximal portion of the plunger rod and the body at the obstacle position, and is separated from the proximal end of the body by the removable blocking component. A drug delivery device including a flange piece, The movement of the obstacle from the obstacle position removing the blocking component, moving the flange piece distally relative to the proximal end of the body A drug delivery device comprising:

61. The drug delivery device according to claim 44, wherein the plunger rod includes a radially outwardly extending protrusion, The obstacle includes a lever having an end portion that is located distal to the protrusion at the obstacle position and that blocks the distal movement of the plunger rod by blocking the distal movement of the protrusion. The movement of the obstacle from the obstacle position includes moving the lever to remove the end portion of the lever distally from the protrusion from its position. A drug delivery device.

62. The drug delivery device according to claim 44, wherein the distal advancement of the plunger rod beyond the administration completion position is prevented by contact between the proximal portion of the plunger rod and a part of a flange piece connected to the body.

63. A drug delivery device, a body, A sleeve fixed to the body, the sleeve including a proximal end, a distal end, and an opening disposed within the circumferential wall of the sleeve; A plunger rod passing through the sleeve, the plunger rod including a distal end portion disposed within the body and a protrusion extending radially; Comprising; The plunger rod is capable of being advanced distally within the body from a ready position to a primed position; In the primed position, the protrusion of the plunger rod is disposed within the opening, and further distal advancement of the plunger rod is resisted by contact between the protrusion and the wall of the opening; A drug delivery device in which pressure can be applied to the protrusion so as to overcome the resistance to further distal advancement of the plunger rod.

64. The drug delivery device according to claim 63, wherein the opening in the sleeve is a second opening, and the sleeve includes a first opening disposed within the circumferential wall of the sleeve proximally from the second opening and a third opening disposed within the circumferential wall of the sleeve distally from the second opening; In the ready position, the protrusion of the plunger rod is disposed within the first opening, and further distal advancement of the plunger rod is resisted by contact between the protrusion and the wall of the first opening; After further distal advancement of the plunger rod beyond the primed position, the protrusion of the plunger rod is disposed within the third opening, and further distal advancement of the plunger rod is prevented. A drug delivery device.

65. The drug delivery device according to claim 63, wherein the radially extending protrusion is a first protrusion, and the plunger rod includes a second protrusion extending radially on the side opposite to the first protrusion; A drug delivery device that overcomes the resistance to further distal advancement of the plunger rod by compressing the first protrusion and the second protrusion toward each other while applying an axial pressure in the distal direction to the plunger rod.

66. The drug delivery device according to claim 63, wherein the protrusion includes a distal-tapering profile that aids in the distal advancement of the plunger rod.

67. A drug delivery device, comprising: A body; A plunger rod disposed within the body, the plunger rod including a distal end portion and a rotatable element; A sleeve fixed to the body, including a proximal opening, into which a plunger rod can be advanced. The sleeve and comprises rotation of the rotatable element causes distal advancement of the plunger rod to a primed position, A drug delivery device in which further rotation of the rotatable element is resisted when the plunger rod reaches the primed position.

68. The drug delivery device according to claim 66 further comprises a collar disposed at the proximal end of the body, the interior of the collar including a proximal threaded portion forming a proximal helical path, the rotatable element includes a proximal portion of the plunger rod including a protrusion, the proximal portion of the plunger rod being rotatable about a longitudinal axis to move the protrusion distally along the proximal helical path, A drug delivery device in which when the protrusion reaches the end of the proximal threaded portion of the collar, the plunger rod reaches the primed position.

69. A drug delivery device according to claim 68, wherein when the plunger rod reaches the primed position, the plunger rod can be pushed into the body to advance the plunger rod distally to an administration completed position.

70. A drug delivery device according to claim 68, wherein the interior of the collar includes a distal threaded portion, the threads of the distal threaded portion being offset from the proximal helical path and forming a distal helical path on the opposite side of the proximal helical path, when the protrusion is aligned with the distal helical path, the plunger rod reaches the primed position, A drug delivery device in which when the proximal portion of the plunger rod is rotated to move the protrusion distally along the distal helical path, the plunger rod advances distally to an administration completed position.

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