Devices and methods for precision dose delivery

Abstract

A delivery device for delivering a volume of a drug, a placebo product, or other product including a fluid is disclosed. The device may include a barrel comprising a longitudinal axis, a proximal end region, and a distal end region. The proximal end region may include an opening, and the barrel may be configured to receive a drug therein. A plunger rod may be arranged at least partially inside the barrel and may protrude from the opening. The plunger rod may include a rack having a plurality of teeth. The device may further include a pinion having a plurality of teeth configured to engage with the plurality of teeth of the rack, and rotation of the pinion relative to the rack may move at least a portion of the plunger rod along the longitudinal axis of the barrel.

Description

Technology Field

[0001] Cross-reference regarding related applications

[0002] The present application is a continuation of U.S. Patent Application No. 17 / 218,875 filed on March 31, 2021, which is a continuation of U.S. Patent Application No. 16 / 900,747 filed on June 12, 2020, which is a continuation of International Application No. PCT / US2018 / 065192 filed on December 12, 2018, under 35 USC 111(a), and claims priority to U.S. Application No. 62 / 598,212 filed on December 13, 2017; U.S. Application No. 62 / 676,047 filed on May 24, 2018; and U.S. Application No. 62 / 722,252 filed on August 24, 2018, all of which are incorporated herein by reference in their entirety. This application is also a continuation of U.S. Patent Application No. 17 / 517,464 filed on November 2, 2021, which is a continuation of U.S. Patent Application No. 16 / 900,747, all of which are incorporated herein by reference in their entirety.

[0003] Public sector

[0004] Aspects of the present disclosure relate to devices and methods for priming or otherwise configuring a dose delivery device, e.g., a syringe, to facilitate precise dose delivery. More specifically, embodiments of the present disclosure relate to devices and methods for loading, storing, transporting, and / or delivering an accurate dose of a pharmaceutical product, a placebo product, or other product containing a fluid. Background Technology

[0005] introduction

[0006] Liquid medications can be delivered to patients in various ways, including injections. In many cases, the precision and accuracy of the volume of liquid medications are critical. For example, healthcare professionals may be concerned with ensuring that the approved or prescribed volume of medication is consistently delivered to each patient who requires the drug. Furthermore, delivering a patient with an overdose, underdose, or even a slight dose can cause undesirable (or negative) clinical impacts. Additionally, some medications are prescribed in small volumes (e.g., less than 100 μL). Human error when preparing and delivering the correct dose of medication for injection in small volumes can affect the patient's drug efficacy and subsequent clinical effects. The problem to be solved

[0007] Additional modes of liquid drug delivery can complicate the goal of accurate dose delivery via injection. For example, to dispense an accurate dose of medication from a device (e.g., a syringe), the device must be loaded with the correct volume of medication. Furthermore, medication must not be accidentally released from the device due to handling, storage, packaging, and / or transport of the loaded device. Additionally, the device may need to be primed to remove air bubbles from the needle and inside the barrel before administering the medication. Incorrect priming of the device may result in too much or too little medication being dispensed, reducing the dose delivered to the patient, or air bubbles being injected from the device into the patient. means of solving the problem

[0008] summation

[0009] A fluid delivery device is disclosed. In an embodiment of the disclosed invention, the device may include a barrel comprising a longitudinal axis, a proximal end region, and a distal end region. The proximal end region may include an opening, and the barrel may be configured to contain a drug therein. A plunger rod (having a piston connected thereto) may be arranged at least partially inside the barrel and may protrude from the opening. The plunger rod may include a rack having a plurality of teeth. The device may further include a pinion having a plurality of teeth configured to engage with the plurality of teeth of the rack, and rotation of the pinion relative to the rack may move at least a portion of the plunger rod along the longitudinal axis of the barrel.

[0010] Various embodiments of the device may include one or more of the following features. The device also includes a shaft attached to the pinion, and rotation of the shaft rotates the pinion relative to the rack. In one embodiment, a knob may be attached to the shaft. In another embodiment, a visualization device (e.g., a magnifying glass) may be arranged on the distal end region of the barrel. In another embodiment, the device may include a stopper inside the barrel, and the stopper may be attached to the distal end of the plunger rod. In an exemplary embodiment, the device includes a circular ratchet arranged coaxially with the pinion, the circular ratchet having a diameter smaller than the diameter of the pinion, and includes a spring-loaded stop arranged on the inner circumference of the pinion, said stop configured to engage with the ratchet, and includes a shaft attached to the ratchet, wherein rotation of the shaft in one direction causes rotation of the pinion, and rotation of the shaft in a second direction does not cause rotation of the pinion. In some embodiments, the ratchet may be arranged inside the pinion. In some embodiments, the pinion may include a plurality of tooth profiles having a first height and a stopper tooth profile having a second height greater than the first height. In another embodiment, the second height of the stopper tooth profile may prevent the pinion from engaging with the plurality of tooth profiles of the rack. In another embodiment, the second height of the stopper tooth profile may be configured to contact either the plunger rod or the rack to stop the rotation of the pinion. In another embodiment, the plunger rod includes an inner column and an outer lumen, and the rack may be arranged on the inner column. In some embodiments, rotation of the pinion relative to the rack may move the inner column of the plunger rod independently of the outer lumen. In some embodiments, the device also includes a shaft removablely attached to the pinion, the shaft prevents the outer lumen of the plunger rod from moving relative to the barrel, and removal of the shaft allows the outer lumen of the plunger rod to move relative to the barrel.

[0011] In some embodiments, the plunger rod further comprises a body and a flange, the flange extending partially along the longitudinal length of the body and having a width greater than the width of the body, the barrel further comprises a plunger restraint, the plunger restraint comprising a through hole configured to allow the flange to pass through a second plunger restraint in a specific direction.

[0012] In another aspect of the present disclosure, a drug delivery device comprises a barrel including a longitudinal axis, a proximal end region, a distal end region, and an interior; the proximal end region may include an opening, and the interior may include a threaded region. The device further comprises a plunger rod arranged at least partially inside the barrel and protruding from the opening, and the plunger rod may include a threaded region configured to engage with the threaded region inside the barrel. Rotation of the plunger rod around the longitudinal axis of the drug delivery device may move the plunger rod along the longitudinal axis.

[0013] Various embodiments of the device may include one or more of the following features. The plunger rod may further include a tab protruding in a first direction from the plunger rod and arranged proximally to the threaded region of the plunger rod, and the threaded region inside the barrel may further include a slot having a size and configuration to allow the tab to pass through the threaded region inside the barrel. In some embodiments, the slot may include a first segment parallel to the longitudinal axis of the drug delivery device and a second segment perpendicular to the longitudinal axis of the drug delivery device. In some embodiments, the slot may include a third segment parallel to the longitudinal axis of the drug delivery device, and the second segment is located between the first segment and the third segment. In other embodiments, the tab is a first tab, and the plunger rod may further include a second tab protruding in a second direction opposite to the first direction from the plunger rod, and the threaded region inside the barrel may further include a second slot having a size and configuration to allow the second tab to pass through the threaded region inside the barrel.

[0014] In another aspect of the present disclosure, the drug delivery device may comprise a barrel having a proximal end region, a distal end region, an opening within the proximal end region, and an internal and internal threaded region. The device further comprises a sleeve partially arranged within the barrel and protruding from the opening in the proximal end region of the barrel, said sleeve may comprise a threaded region that engages with the threaded region within the barrel. The device also comprises a plunger rod at least partially arranged within the sleeve and a stopper within the barrel and distal from the sleeve, said stopper connected to the distal end of the plunger rod. Rotation of the sleeve in a first direction around the longitudinal axis of the drug delivery device may move the sleeve toward the distal end region of the barrel.

[0015] Various embodiments of the device may include one or more of the following features. Rotation of the sleeve in a first direction may move the stopper toward the distal end region of the barrel. In some embodiments, the sleeve may include an internal passage, and the stopper may have a diameter greater than the diameter of the internal passage. In some embodiments, the sleeve may include a tab arranged on the outside of the sleeve, said tab may be arranged proximally from a threaded region inside the barrel, said tab may stop the movement of the sleeve toward the distal end of the barrel. In another embodiment, said tab may be configured to stop the movement of the sleeve toward the distal end region of the barrel after the drug delivery device is primed. In additional embodiments, said tab may be a first tab, and the sleeve may further include a second tab arranged on the outside of the sleeve, said second tab may be arranged proximally from a threaded region inside the barrel, said second tab may stop the movement of the sleeve toward the distal end region of the barrel.

[0016] In another aspect of the present disclosure, the drug delivery device may include a barrel comprising a proximal end region and a distal end region, wherein the proximal end region may include an opening. The device also includes a plunger rod comprising a body and a flange, wherein the flange partially extends along the longitudinal length of the body and has a width greater than the width of the body, and the plunger rod is at least partially arranged inside the barrel and protrudes from the opening. The device also includes a first plunger restraint arranged on the barrel, wherein the first plunger restraint is configured to block the flange from entering the barrel and includes a second plunger restraint arranged inside the barrel, wherein the second plunger restraint includes a through hole configured to allow the flange to pass through the second plunger restraint in a specific direction.

[0017] Various embodiments of the device may include one or more of the following features. In some embodiments, the first plunger restraint may be removable. In some embodiments, the first plunger restraint may be brittle. In other embodiments, the distance between the first plunger restraint and the second plunger restraint may be equal to the distance the stopper must travel to prime the drug delivery device. In other embodiments, the plunger rod may be rotatable around the longitudinal axis of the drug delivery device.

[0018] In another aspect of the present disclosure, a method for dispensing a substance from a drug delivery device having a plunger rod and a barrel may include the steps of advancing a plunger rod into a barrel by a predetermined distance until the advancing motion of the plunger rod is resisted by a stopper, deactivating the stopper, and operating the plunger rod to deliver the substance.

[0019] Various embodiments of the device may include one or more of the following features. In some embodiments, the step of advancing the plunger rod may include the step of rotating the pinion relative to a rack arranged on the plunger rod. In some embodiments, the stop may include a shaft removablely attached to the pinion, and the step of deactivating the stop may include the step of removing the shaft from the pinion. In other embodiments, the step of deactivating the stop may include the step of rotating the plunger rod. In some embodiments, the plunger rod may include a flange, and the stop may include a restraint that prevents the flange from entering the barrel. In other embodiments, the step of deactivating the stop may include the step of removing the restraint. In some embodiments, the step of deactivating the stop may include the step of destroying the restraint. Brief explanation of the drawing

[0020] The accompanying drawings, included in and constituting part of this specification, serve to illustrate various exemplary embodiments and, together with the detailed description, explain the principles of the disclosed embodiments. The drawings represent different aspects of this disclosure, and where appropriate, reference numbers indicating similar structures, parts, materials, and / or elements in different drawings are similarly denoted. Various combinations of structures, parts, and / or elements in various embodiments other than those specifically illustrated are considered and understood to be within the scope of this disclosure. There are many embodiments described and illustrated in this specification. The described apparatus and method are not limited to any single embodiment or example thereof, nor are they limited to any combination and / or permutation of such embodiments and / or examples. Additionally, each embodiment and / or example of the described invention may be used alone or in combination with one or more other embodiments and / or examples of the described invention. For brevity, specific permutations and combinations are not described and / or illustrated separately in this specification. FIG. 1 illustrates an exemplary delivery device (e.g., a syringe) according to one embodiment of the present disclosure. FIG. 2 illustrates an exemplary stop and ratchet mechanism for a transmission device according to one embodiment of the present disclosure. FIGS. 3a and 3b illustrate an exemplary restraint mechanism for a delivery device according to one embodiment of the present disclosure. FIGS. 3C and 3D illustrate an exemplary telescoping mechanism for a delivery device according to one embodiment of the present disclosure. FIGS. 4a and 4b illustrate an exemplary rotational restraint mechanism for a transmission device according to an embodiment of the present disclosure. FIGS. 4c to 4e illustrate an exemplary transmission device having an exemplary rotational restraint mechanism at various positions according to one embodiment of the present disclosure. FIG. 5 illustrates an exemplary delivery device according to one embodiment of the present disclosure. FIGS. 6a to 6e illustrate exemplary transmission devices and restraint mechanisms according to one embodiment of the present disclosure. FIG. 7a illustrates an exemplary delivery device according to one embodiment of the present disclosure. Figure 7b shows the screw portion of the transmission device of Figure 7a. FIG. 8 illustrates an optional embodiment of the screw portion of FIG. 7b. FIG. 9a illustrates an exemplary delivery device according to one embodiment of the present disclosure. FIGS. 9b to 9d illustrate the restraint parts of the transmission device of FIG. 9a. FIGS. 10a through 10c illustrate other exemplary delivery devices according to additional embodiments of the present disclosure. FIGS. 11a and FIGS. 11b illustrate other exemplary delivery devices according to additional embodiments of the present disclosure. FIG. 12 illustrates an exemplary delivery device according to additional embodiments of the present disclosure. FIGS. 13a through 13c illustrate exemplary priming and delivery mechanisms for a delivery device according to additional embodiments of the present disclosure. FIGS. 14a through 14c illustrate other exemplary priming and delivery mechanisms for a delivery device according to additional embodiments of the present disclosure. FIGS. 15a through 15e illustrate different rotational restraint mechanisms for a transmission device according to additional embodiments of the present disclosure. FIGS. 16a through 16e illustrate other exemplary delivery devices and restraint mechanisms according to additional embodiments of the present disclosure. FIGS. 17a through 17c illustrate other exemplary delivery devices and mechanisms according to additional embodiments of the present disclosure. FIGS. 18a through 18f illustrate restraint and priming mechanisms for a delivery device according to additional embodiments of the present disclosure. FIGS. 19a through 19e illustrate different restraint and priming mechanisms for a delivery device according to additional embodiments of the present disclosure. FIGS. 20a through 20c illustrate different restraint and priming mechanisms for a delivery device according to additional embodiments of the present disclosure. As used in this application, the terms “comprising,” “comprising,” “including,” “including,” or any other variation thereof may include, with non-exclusive inclusion, a device comprising a list of processes, methods, articles, or components, which does not include only said components, but may include other elements not explicitly listed or inherent in said processes, methods, articles, or devices. The term “exemplary” is used in the sense of “examples” rather than “ideal.” In particular, an embodiment or implementation described herein as “examples” or “exemplary” should not be interpreted as being, for example, more desirable or advantageous than other embodiments or implementations; rather, it is intended to reflect or indicate that the embodiment(s) are “examples” rather than “ideal.” Additionally, the terms “first,” “second,” etc., in this specification are used to distinguish elements, structures, steps, or processes from others without indicating any order, quantity, or importance. Additionally, in this specification, the terms "one (a)" and "one (an)" do not indicate a limitation of quantity but indicate that there is one or more of the mentioned items. Specific details for implementing the invention

[0021] Embodiments of this disclosure may be used in addition to and / or combination with features of U.S. Provisional Application No. 62 / 598,212, which are incorporated herein by reference in their entirety.

[0022] The embodiments of this disclosure may be used with any type of fluid-containing product, such as liquid medicines, liquid placebos, or other liquids that can be dispensed in dose form. In some embodiments, the medicine may contain one or more active ingredients, including small or large molecules or biological agents, such as analgesics, steroids, or biological agents. As used herein, the term “biological” may refer to large molecules produced within a living system, such as cells (e.g., greater than 15 kDa, greater than 30 kDa, greater than 50 kDa, greater than 75 kDa, or greater than 100 kDa). Biological agents may include proteins (e.g., antibodies), nucleic acids, large sugars, etc. Unlike small molecules, which may have well-defined chemical structures, biological agents may have very complex structures that cannot be easily quantified by experimental methods. As used herein, the term “medicine” may refer to a specific volume of a formulated drug substance classified as a first package component for packaging, transport, delivery, and / or administration to a patient.

[0023] The term “first packaging component” refers to a packaging component for a medicine, such as a drug container, designed and manufactured to come into direct physical contact with the compounded drug substance (e.g., refer to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research’s Industry Guidance on Container Sealing Systems for Packaging Medicines and Biologics for Human Use (May 1999), which is incorporated herein by reference). Examples of the first packaging component include pre-fillable syringes, Luer syringes, cartridges, and vials made of glass, plastic, and / or other materials.

[0024] Embodiments of the present disclosure may be used with products having a typically small dose volume, e.g., ophthalmic medicines. In some embodiments, the device of the present disclosure may be used with medicines containing antigen-binding molecules. In some features, the antigen-binding molecule may be an antibody or an antigen-binding fragment. In some embodiments, the device of this disclosure may be suitable for use with a medicine comprising, for example, aflibercept, alirocumab, avicipar pegol, bevacizumab, brorucizumab, convercept, dupilumab, evolocumab, tocilizumab, cetolizumab, abatacept, rituximab, infliximab, ranibizumab, sarilumab, adalimumab, anarchira, trastuzumab, pegfilgrastim, interferon beta-1a, insulin glargine [of rDNA origin], epoetin alpha, darbepoetin, filagratim, golimumab, etanercept, an antigen-binding fragment of any of the above components, or a combination of binding regions such as a bispecific antibody against VEGF or angiopoietin-2.

[0025] For some products, particularly for ophthalmic or other pharmaceuticals, dose accuracy may be particularly important. However, the embodiments of this disclosure are considered applicable to any other liquid products or any other situation where an accurate method for reliably establishing and administering an accurate dose or delivery volume is advantageous.

[0026] In some embodiments, the device according to this disclosure may be manufactured, packaged, filled, and / or otherwise primed according to the process associated with the product (e.g., pharmaceutical) in which it may be used. For example, in some embodiments, the device according to this disclosure may be sterilized before or after filling and / or packaging. For example, in some embodiments, the device according to this disclosure may be finally sterilized using any suitable method in the industry, such as filling and packaging in blister packaging. For example, the device according to the invention may be finally sterilized using a chemical sterilization method, such as a method comprising ethylene oxide or hydrogen oxide (e.g., vaporized hydrogen oxide). In some embodiments, the device according to this disclosure may be finally sterilized using, for example, the method described in International Application No. PCT / US2018 / 021013 filed March 6, 2018, which is incorporated herein by reference in its entirety.

[0027] Commercially available dose delivery devices, such as syringes for use with pre-filled syringes or vials, are not necessarily able to accurately load the desired volume of product, prime the device, release excess medicine from the device, and / or remove air bubbles from the device. In particular, in a dose delivery device comprising a small volume of pharmaceutical (such as about 25μL to about 50μL, about 50μL to about 100μL, about 25μL to about 100μL, about 50μL to about 150μL, about 100μL to about 250μL, about 100μL to about 150μL, about 150μL to about 250μL, about 200μL to about 250μL, about 200μL to about 250μL, about 200μL to about 500μL, or about 250μL to about 500μL), the drug inside the device It can be difficult to visually confirm the presence of the correct dose. In the current dose delivery device market, particularly in the syringe market, there is a need for devices that allow users to accurately set up a syringe (e.g., a pre-filled or refillable / rechargeable syringe) to deliver a small volume of product, and to verify or be certain that the syringe is primed, air bubbles are removed from the syringe, and / or that the dose inside the syringe is accurate. The embodiments of this disclosure can assist manufacturers, pharmaceutical suppliers, healthcare professionals, and / or patients in accurately filling or otherwise preparing a dose delivery device, priming the device, removing air bubbles from the device, verifying the dose, and / or administering the dose from the device to a patient.Furthermore, embodiments of the present disclosure may assist in preventing or mitigating errors or changes during the manufacture or use of the device, such as errors or changes in the arrangement of dose lines on the device, changes in the geometric shape of the device (e.g., changes in the geometric shape of the syringe neck), and / or changes or errors in the setting of the dose lines before delivery of the product.

[0028] In some examples, embodiments of this disclosure may be particularly helpful to individuals who may have difficulty setting the dose accurately and precisely. For example, embodiments of this disclosure may help the elderly, children, or persons with physical or mental disabilities set the correct dose.

[0029] Various embodiments of dose delivery devices, particularly syringes, are described herein. In some examples, the embodiments disclosed herein may be used in conjunction with conventional syringe body parts to modify standard products, thereby reducing the development and manufacturing time of the dose delivery device. In other examples, the embodiments disclosed herein may be incorporated into the device during the manufacturing process. The syringes described herein may be pre-filled or refillable / rechargeable.

[0030] Embodiments of the present disclosure may include a syringe having a rotating part, a screw part, a spring, a gear, etc., so that a user can precisely control the movement of dose setting and transmission elements, such as a plunger and / or a stopper, for example. In some embodiments, for example, a screw and gear mechanism may be used to transmit rotational motion (e.g., on a knob or dial) to linear motion of a plunger, and thus to set the plunger rod of the syringe to a predefined position with reduced human effort and / or relatively high precision. Due to reduced human effort and / or relatively high precision, embodiments of the present disclosure are also considered to be capable of reducing human error.

[0031] In some embodiments, to improve the visibility of a dose measurement marker on the device, a visualization device such as a magnifying glass may have a delivery device, be attached to the delivery device, or be arranged in a different way on the delivery device. An aspect of one embodiment (e.g., a magnifying glass, a sleeve, a guide pin, a channel, a screw and gear mechanism, a rotating part, a screw part, a grip, a spring, etc.) may be combined with an aspect of one or more other embodiments to form various combinations and permutations of features within a single device.

[0032] In some embodiments, the device according to this disclosure may be illustrated as comprising one type of plunger rod and plunger, or may be illustrated as comprising a general schematic diagram of a plunger rod and plunger. For example, some devices according to this disclosure may be illustrated or described as comprising a plunger rod having a threaded end that engages with a screw, for example, on the inner side of the plunger, so that the plunger rod and the plunger can be screwed together. It is considered that many and / or different configurations of the plunger rod and plunger may be suitable for each embodiment disclosed herein. For example, in some examples, the screw-type plunger rod and plunger may be used with the embodiments disclosed herein. In some embodiments, the plunger rod may not be attached to the plunger, but instead may be arranged around, in close proximity to, or on the same plane as the plunger rod so that pressure may be applied from the plunger rod toward the plunger, but the retraction, twisting, or other movement of the plunger rod may not cause the plunger to retract, twist, or other movement in the same way. As another example, in some embodiments, the plunger rod may be attached to the plunger by an adhesive or may be a single part with the plunger (e.g., may be manufactured within a single mold with the plunger).

[0033] In some embodiments, the device according to the present disclosure may include various aesthetic features related to the intended user of the device. For example, the device according to the present disclosure may be manufactured and sold for use by pediatric patients. In such cases, the device according to the present disclosure may include child-friendly coloring, cartoon images, or other aesthetic features that are appealing to children. In some cases, the device according to the present disclosure may include text, labeling, or other features designed to be easily recognized by the intended user. For example, a device for pediatric use or for use by a person with a disability or the elderly may have larger and more accessible labeling with text, and the text display may be more easily recognized and readable by the user(s) of the device.

[0034] FIG. 1 illustrates a syringe (10) containing a certain volume of medicine (12) and having a dose release control mechanism. The dose release control mechanism may include a rack (2) and a pinion (3). The rack (2) may be formed on the inner surface of the plunger rod (1) of the syringe (10) or attached to the inner surface of the plunger rod (1). In some embodiments, the rack (2) may be carved, machined, or formed, for example, on the plunger rod (1). The rack (2) may include a plurality of teeth extending along the length of the rack.

[0035] The pinion (3) may also include a plurality of teeth configured to engage with the teeth of the rack (2). The pinion (3) may be operably connected to an actuator (e.g., a dial or knob) located outside the plunger rod (1) by the pinion rod (4). For example, as shown in FIG. 1, rotation of the dial (5) may cause rotation of the pinion rod (4) and consequently rotation of the pinion (3). Thus, the pinion rod (4) may extend from an inner region of the syringe (10) (connected to the pinion (3)) to an outer region of the syringe (10) (connected to the dial (5)). In the embodiment of FIG. 1, the pinion rod (4) may be partially or completely extended through a finger flange (7) (e.g. integrally formed or attached to the syringe (10)). In another embodiment, the pinion rod (4) may extend through the body wall of the plunger rod (1) and / or the syringe barrel (9) of the syringe (10). The pinion rod (4) may be supported by a gasket or seal, such as an O-ring (6), and exits the finger flange (7) (or, if appropriate, the syringe barrel (9)). While the pinion (3) is in a moving and / or stationary state, the O-ring (6) may provide physical support to the pinion rod (4) and / or the pinion (3). Although the O-ring (6) is described as providing structural support to the pinion rod (4) and / or the pinion (3), the O-ring (6) is considered to be capable of sealing the inner region of the plunger rod (1) from the outer region or sealing both. Additionally, other seals or gaskets or combinations thereof may be used instead of or in addition to the O-ring (6), and said seals or gaskets may or may not provide structural support and / or sealing ring. For example, such seals or gaskets may simply provide a barrier protecting the inner area of ​​the syringe from the outer area, or they may provide structural support and also act as a barrier.

[0036] The teeth of the pinion (3) can be engaged with the teeth of the rack (2) so that when the pinion (3) is rotated through the dial (5), the rotational movement of the pinion (3) can cause translational movement of the plunger rod (1). Thus, the plunger rod (1) can be moved distally and / or proximally within the syringe barrel (9) by the rotating pinion (3), and the piston (8) (e.g., stopper) can also be moved within the syringe barrel (9). By the rotation of the dial (5), the piston (8) (which may act as a stopper) can be moved gradually toward the needle end of the syringe (10) so that air and excess drug can be expelled through the needle (13), priming needle (13) for the injection of an appropriate dose of medicine (12).

[0037] The size and structure of the rack (2) and pinion (3) may be determined such that rotation of the pinion (3) in a given direction or by a given size (e.g., one clockwise rotation) can separate the rack (2) and pinion (3) from each other, thereby stopping the ability of the dial (5) to advance the piston (8). In some embodiments, when the dial (5) is rotated clockwise or counterclockwise by a predetermined size, the rack (2) and / or pinion (3) may stop moving. For example, the pinion (3) may be prevented from moving further by reaching the proximal end of the rack (2), separating from the rack (2), separating from the pinion rod (4), or approaching a stopper, or the dial (5) may be rotated only by a specified amount. Thus, the dial (5) and pinion (3) can be rotated in a given direction and by a given size to complete the priming of the syringe needle.

[0038] In some embodiments, when the plunger rod (1) is moved to a desired size (where the rotation of the dial (5) and / or pinion (3) may or may not be stopped), the user may pull the dial (5) outward from the plunger rod (1). The movement of the dial (5) outward may separate the dial (5) from the pinion rod (4) and / or separate the pinion rod (4) from the pinion (3). In some embodiments, the pinion rod (4) may extend through an opening in the side wall of the plunger rod (1), and pulling the dial (5) retracts the pinion rod (4) from the opening so that the pinion rod (4) no longer prevents the movement of the plunger rod (1). In some embodiments, pulling the dial (5) may constrain the dial in place, preventing further movement of the plunger rod (1) by the use of the dial (5). In some embodiments, when the dial (5) is pulled outward, the outer plunger rod is released so that the plunger rod can move freely regardless of whether the movement of the dial (5) is constrained. In some embodiments, when the dial (5) and / or the pinion rod (4) is pulled outward, the pinion (3) can be separated from the rack (2). In some embodiments, the user cannot apply pressure to the plunger rod (1) until the pinion (3) reaches the final position and / or the dial (5) is pulled outward.

[0039] The dial (5) may be the only mechanism capable of moving the plunger rod (1) until the syringe (10) is primed. For example, until the pinion (3) is separated from the rack (2), the user can prevent pressing the plunger rod (1) (and / or proximal pulling the plunger rod (1)) by the paired teeth of the rack (2) and the pinion (3). Thus, the dispensing of the medicine (12) can be inhibited until the syringe (10) is primed, and under- or over-priming of the syringe (10) is inhibited and accurate dispensing of the medicine (12) can be promoted.

[0040] As illustrated in the embodiment of FIG. 1, the syringe (10) may optionally include a magnifying glass (11) attached to or built into the syringe barrel (9). The magnifying glass (11) may assist in reading measurement markings on the syringe barrel (9), assist in observing the presence or absence of bubbles within the syringe barrel (9), and / or assist in determining whether a dose of the medicine (12) has been fully dispensed from the syringe (10). The magnifying glass (11) may be contained within the distal region of the syringe (10) and may have any suitable shape or size. For example, the magnifying glass (11) may have a circular or rectangular shape or may wrap around all or part of the circumference of the syringe barrel (9). In other embodiments, the magnifying glass (11) may not be included.

[0041] The embodiment illustrated in FIG. 1 may operate as follows. The dial (5) may be rotated in a given direction and by a given amount until the rotation of the pinion (3) stops. The user may detect whether the pinion (3) has stopped when the dial (5) can no longer rotate and / or when the movement of the plunger rod (1) is stopped. As described above, the pinion (3) may stop moving, for example, when it reaches the end area of ​​the rack (2), is disengaged from the rack (2), is disengaged from the pinion rod (4), is adjacent to a stopper, or because the dial (5) can only rotate by a given amount. Optionally or additionally, in some embodiments, the dial (5) may be pulled outward by the user to prevent further movement of the plunger rod (1) through the dial (5).

[0042] When the movement of the plunger rod (1) through the dial (5) is completed, the user may optionally check the dose level of the medicine within the syringe barrel (9) and / or optionally check whether air is trapped within the syringe barrel (9). Next, the proximal end of the plunger rod (1) may be pressurized to inject a dose of the medicine.

[0043] FIG. 2 illustrates an exemplary variation of the pinion (3) shown in FIG. 1. The pinion (20) of FIG. 2 includes an internal ratchet and stop mechanism to allow rotation of the pinion (20) in a first direction and prevent rotation of the pinion (20) in a second direction opposite to the first direction. For example, only clockwise rotation may be allowed and counterclockwise rotation blocked, or vice versa. In some embodiments, the pinion (20) may prevent rotation of the plunger rod (1) in a direction in which it moves proximally away from the needle end of the syringe (10), whereas rotation of the plunger rod (1) in a direction in which it moves distally toward the needle end of the syringe (10) is allowed.

[0044] As illustrated in FIG. 2, the ratchet (23) may be coaxial with the pinion (20), and the dial (5) (Fig. 1) may be connected to the ratchet (23) through the center (25) of the ratchet (23) via a pinion rod (such as the pinion rod (4) illustrated in FIG. 1). The ratchet (23) may include an angled tooth portion (24). An inner region of the pinion (20) may be operably connected to the inner region and may include a spring load stop (22). The stop (22) is positioned at an angle that matches the angle of the ratchet tooth portion (24) and is positioned sufficiently close so that the free end of the stop (22) can engage with the ratchet tooth portion (24). Each ratchet tooth (24) may include a curved surface on which the free end of each stop (22) slides and a protruding surface on which the free end of each stop (22) can engage and stop. When the dial (5) of FIG. 1 rotates in one direction (e.g., the direction in which the plunger rod (1) moves away from the needle end of the syringe (10), it causes the ratchet (23) to rotate, so that the ratchet tooth (24) does not engage with the stop (22) and the ratchet (23) can rotate independently of the pinion (20). However, when the dial (5) rotates in the opposite direction, the ratchet (23) engages with the stop (22) and rotates the pinion (20), so that the plunger rod (1) and piston (8) move distally toward the needle end of the device, allowing priming of the needle (13) and air discharge.

[0045] FIGS. 3A and FIGS. 3B illustrate other variations of the pinion (3) shown in FIG. 1. In this embodiment, the plunger rod (30) may include a rack (32) extending along at least a portion of its length. The rack (32) may include a plurality of tooth portions (34) configured to engage with the tooth portion (36) on the pinion (33). In addition to the tooth portion (36), the pinion (33) may include a stopper tooth portion in the form of a protrusion (35). The protrusion (35) may extend further outward from the pinion (33) in a radial direction beyond the tooth portion (36) and may have a height greater than the height of the tooth portion (36). The pinion (33) can rotate along the rack (32) (Fig. 3a) until the protrusion (35) of the pinion (33) contacts the rack (32) or the plunger rod (30) (Fig. 3b), thereby stopping the rotation of the pinion (33). In this way, the protrusion (35) can prevent one-time over-rotation of the pinion (33). Stopping the rotation of the pinion (33) consequently stops the forward movement of the plunger rod (30) and the piston (38) beyond a predetermined point. The predetermined point may correspond, for example, to a point (see Fig. 1) where an excess dose of air and medicine can be discharged from the syringe (10), thereby forming the correct priming of the syringe (10). In some embodiments, assuming that the protrusion (35) contacts the plunger rod (30) and the pinion (33) is in the position shown in FIG. 3b, the protrusion (35) may not have a rack (32), and the plunger rod (30) may slide freely against the protrusion. Thus, in the embodiments of FIG. 3a and FIG. 3b, instead of a rack, a length controlling the amount of movement of the plunger rod (30) is allocated for the priming of the syringe, and the circumference of the pinion (33) may control said movement.

[0046] The physical interruption of additional pinion movement caused by the protrusion (35) on the pinion (33) can also provide the user with tactile feedback indicating that the appropriate dose has been set and the syringe (10) has been primed. Including the protrusion (35) on the pinion (33) can additionally prevent excessive or insufficient rotation of the pinion (33) in an undesirable direction (e.g., allowing movement of the plunger rod in a proximal direction). The protrusion (35) may be useful for preventing overfilling of the syringe (10) or the entry of air into the syringe (10) during handling, packaging, storage, and / or transport. In a further embodiment, the protrusion (35) may be positioned on a rack (32) instead of or in addition to the pinion (33) to control the movement of the pinion (33).

[0047] FIGS. 3C and FIGS. 3D illustrate other variations of the plunger rod (1) shown in FIGS. 1. The plunger rod (40) of FIGS. 3C and FIGS. 3D may include a restraining mechanism configured to prevent accidental pressurization of the piston (48), for example, when the syringe is packaged, stored, handled, and / or filled. In some embodiments, the plunger rod (40) may include a telescoping inner portion (49) (e.g., an inner tubular portion or column) having a rack (42). The inner portion (49) of the plunger rod (40) may include a piston (48) connected to its distal end. The inner portion (49) may move relative to a fixed outer portion (41) (e.g., an outer lumen). Rotation of the dial (45) causes the inner portion (49) to extend distally from the outer portion (41), allowing the inner portion (49) to move independently from the outer portion (41).

[0048] The dial (45) can be operably connected to the telescoping inner part (49) by a pinion rod (44) (e.g., a shaft) and a pinion (43). Rotation of the dial (45) can, in turn, rotate the piston rod (44) and the pinion (43). The teeth of the pinion (43) engage with the teeth of the rack (42) of the inner part (49) to move the inner part (49) distally from the outer part (41). FIG. 3c shows the inner part (49) of the telescoping plunger rod (40) retracted within the outer part (41), and FIG. 3d shows the inner part (49) of the telescoping plunger rod (40) extending from the outer part (41). Thus, the rotating dial (45) can move the piston (48) distally toward the needle end of the syringe to prime the needle and remove air bubbles.

[0049] The inner portion (49) of the plunger rod (40) may extend from the outer portion (41) during the needle priming process, but the outer portion (41) may not move during dose preparation. In this exemplary embodiment, the dial (45) and / or pinion rod (44) may optionally interfere with the outer portion (41) of the plunger rod (40) so that the plunger rod (40) cannot be moved relative to the syringe barrel and the thumb pad (47) of the plunger rod (40) cannot be compressed and pressurized during dose preparation. For example, to connect the pinion (43) to the dial (45), the pinion rod (44) may extend through the opening of the telescoping outer portion (41) of the plunger rod (40). Therefore, when the pinion rod (44) is connected to the pinion (43), the movement of the outer part (41) can be prevented if the pinion rod (44) extends through the side wall of the outer part (41). Since the outer part (41) cannot move, the plunger rod may not be pressed. When the dial (45) is pulled, the pinion rod (44) is separated from the pinion (43), so that the pinion rod (44) can no longer extend through the outer part (41). Consequently, once the dial (45) is pulled, the pinion rod (44) is removed from the connection with the telescoping part and cannot extend through the telescoping part, allowing the plunger rod (40) to move freely within the syringe barrel. When the plunger rod (40) moves distally by pressing the thumb pad (47), administration of the dose can be allowed.

[0050] In the embodiments of FIG. 3c and FIG. 3d, when the thumb pad (47) is pressed, the telescoping inner portion (49) of the plunger rod (40) is held in place relative to the outer portion (41), so that the pressure of the thumb pad (47) and the movement of the plunger rod (40) prevent the telescoping inner portion (49) from collapsing again within the outer portion (41). The outer portion (41) and the inner portion (49) of the plunger rod (40) can be joined to each other, for example, with a positive restraining tooth (for example, the tooth (46) of the outer portion (41)) so that the inner portion (49) extends distally from the outer portion (41) but the inner portion (49) is prevented from moving backward into the outer portion (41). Therefore, when the thumb pad (47) is pressed and the plunger rod (40) moves distally to release the dose, the two telescoping parts can be prevented from folding over each other. Additionally, proximal movement of the inner part (49) can be prevented during the priming process.

[0051] When in use, the dial (45) may be rotated to prime the syringe as illustrated in FIG. 3c and FIG. 3d, and may allow for finer and / or more controlled movement of the plunger rod (40) for such priming. As previously mentioned, the inclusion of the dial (45) may prevent the discharge of any volume of product for dosing until priming is completed, for example, until the dial (45) is pulled outward to release the movement of the plunger rod (40). Although one form of restraining mechanism associated with the dial (45) is described, any suitable type of restraining mechanism may be included, and such restraining mechanism is considered to be activated and / or deactivated by pulling, pressing, sliding, or otherwise manipulating the dial (45).

[0052] For example, other variations of the restraint mechanism are illustrated in the cross-sectional views of FIGS. 4a and 4b. The restraint mechanism of FIGS. 4a and 4b may be used in place of or in addition to FIGS. 3c and 3d. In the embodiment of FIG. 4a, the entire plunger rod (50) or the proximal region of the plunger rod (50) (e.g., the telescoping outer portion of the plunger rod) includes a physical stop (e.g., an interference bump or protrusion) to prevent pressure on the plunger rod (50) during the dose preparation and priming process, or to allow sufficient pressure to prepare and prime the dose. In the embodiment of FIG. 4a, the plunger rod (50) and / or the portion of the plunger rod (50) having the protrusion (51) may be prevented from moving distally by the interference protrusion (51) (illustrated in the upper-lower cross-section) until the plunger rod (50) is rotated against other parts of the syringe, e.g., finger flange (not shown), stopper (53) located at the inlet of the syringe barrel (58), and / or syringe barrel (58). In the embodiment of FIG. 4b, the plunger rod (50) may have a cross-sectional shape that is not radially symmetrical overall, so that the plunger rod may be prevented from moving distally by the shape of the plunger rod (50) until the plunger rod (50) is rotated against other parts of the syringe, e.g., finger flange, stopper (53), and / or syringe barrel (58). To press the plunger rod (50), the plunger rod (50), stopper (53) and / or barrel (58) may be rotated relative to other parts of the syringe to press the plunger rod (50) sufficiently to fully dispense a drug dose.

[0053] In some embodiments, the plunger rod (50) may not be able to move past the finger flange or stopper (53) within the syringe barrel, for example, until the plunger rod (50) is rotated by a specific number of angles (e.g., 90 degrees) relative to the finger flange or stopper. In some embodiments, the finger flange or stopper (53) may be rotated (e.g., 90 degrees) relative to the plunger rod (50). For example, the plunger rod (50) may have a specific cross-sectional shape (e.g., a generally rectangular shape and / or protrusions (51)), and the syringe barrel (58) and / or stopper (53) may include a blocking part and / or the shape and size of the syringe barrel and / or stopper may be determined such that the protrusions (51) of the plunger rod (50) cannot pass through and be assembled until the related part is sufficiently rotated so that the mating shapes are aligned and the plunger rod (50) can pass through.

[0054] In some embodiments, the opening (52) of the stopper (53) and / or syringe barrel (58) (and / or finger flange, not shown) and the cross-section of the plunger rod (50) may have a paired shape, but may be offset from each other until one or the other is not rotated until the shapes are aligned. In FIGS. 4a and 4b, the general shape of the protrusion (51) or the plunger rod (50) is not aligned with the opening (52) until the finger flange or the plunger rod (50) is sufficiently rotated. When two protrusions (51) are shown in FIG. 4a and a given cross-sectional shape of the plunger rod (50) is shown in FIG. 4b, it is considered that any suitable number, size, and shape of the opening and protrusion and / or cross-sectional shape may be used. Additionally, exemplary embodiments are illustrated as requiring a rotation of 90 degrees, but it is considered that any appropriate amount of rotation of 90 degrees (less than or greater) may be required.

[0055] FIGS. 4c through 4e illustrate side views of a syringe (54) having a plunger rod (50) having a protrusion (51) at three different positions. The syringe (54) may include a stopper (53), and the protrusion (51) cannot be assembled through the stopper until the protrusion (51) and the stopper (53) are rotated relative to each other so that the shape of the protrusion (51) is assembled into the mating opening of the stopper (53) (e.g., refer to the dotted line in FIG. 4a). The plunger rod (50) may be coupled to a plunger (56) that can be assembled snugly within the barrel (58) of the syringe (54). The syringe (54) may contain a volume of medicine (12) suitable for dispensing from the syringe (54). In FIG. 4c, the syringe (54) is shown in a first non-operating position. The protrusion (51) is positioned around the plunger rod (50) in a first direction. In FIG. 4d, the syringe (54) is shown in a second position that is partially operated. In the first direction, the protrusion (51) is blocked from passing through the stopper (53), thereby blocking additional pressure on the plunger rod (50). In FIG. 4e, the syringe (54) is shown in a fully operated position. When the plunger rod (50) rotates (e.g., indicated by a curved arrow or optionally in the opposite direction), the protrusion (51) can be moved around the plunger rod (50) in a second direction. In the second direction, the protrusion (51) passes through the stopper (53) to allow additional pressure on the plunger rod (50) and the plunger (56).

[0056] In some embodiments, the protrusion (51) is located on the plunger rod (50) so that the protrusions do not protrude from the general profile of the syringe (54). For example, the protrusion (51) may be located inside, for example, the barrel (58) before the syringe (54) is operated (e.g., FIG. 4c). In these embodiments, the protrusion (51) may be located inside, for example, a portion of the stopper (53) before the syringe (54) is operated. In some of these embodiments, the stopper (53) may have a greater thickness to accommodate the protrusion (51), may have a proximal cavity having the size and structure to accommodate the protrusion (51) in a first direction, and may have a more distal cavity configured to accommodate the protrusion (51) in a second direction so that the plunger rod (50) can move distally by rotation of the plunger rod (50) and / or the protrusion (51).

[0057] In some embodiments, a second set of protrusions may be included within the plunger rod (50) proximal or distal from the protrusion (51). The second set of protrusions may have a geometry similar to that of the protrusion (51) but may be radially offset from the protrusion (51) so that additional rotation of the plunger rod (50) is required for the second set of protrusions to pass through the opening of, for example, the stopper (53) (e.g., the opening (52)). Optionally, the second set of protrusions may have a shape that cannot be assembled through the opening so that the plunger rod (50) is blocked from moving in a direction given by the shape of the plunger rod. Such a second set of protrusions may be useful, for example, for restricting the movement of the plunger rod (50) before or after the protrusion (51) passes through the opening. In some embodiments, this type of movement limiting may be used to control the amount of movement of the plunger rod (50) that allows the priming syringe (10) to be primed before the plunger rod (50) makes further rotations to dispense a dose from the syringe (10). In additional embodiments, this type of movement limiting may be used to control the dose that can be dispensed from the syringe (50). For example, refer to FIGS. 15a through 15e described below. As with all embodiments shown and described herein, the above embodiment may be combined with features of other embodiments described herein.

[0058] In some embodiments, the syringe may be configured to provide feedback to the user to indicate when the rotation of the plunger rod (50) and the protrusion (51) and / or finger flange is completed and when the plunger rod (50) is aligned with the opening (52) (see FIG. 4a to 4b). For example, a "click" sound or other auditory or tactile feedback mechanism may be included in the syringe.

[0059] Referring to FIG. 5, another exemplary syringe (60) is illustrated having a dose release control mechanism. In the embodiment of FIG. 5, the dose release control mechanism comprises two sets of angled helical threads. A first set of helical threads (62) is included on the outer surface of a plunger rod (61). The threads (62) may extend around the entire circumference of the plunger rod (61) or around a portion of the circumference. A second set of helical threads (63), paired with the outer helical threads (62) of the plunger rod (61), is included on the inner circumference of the syringe barrel (69) and / or finger flange (64) through which the plunger rod (61) passes. The threads (62) may extend around the entire circumference of the syringe barrel (69) and / or finger flange (64) or around a portion of the circumference. The screw threads (62, 63) may be formed, shaped, machined, attached, or otherwise included on the surface of the plunger rod (61) and the syringe barrel (69) or finger flange (64), respectively.

[0060] The plunger rod (61) rotates to move the thread (62) of the plunger rod (61) through the thread (63), thereby converting the torsional motion of the plunger rod (61) into translational (or linear) motion of the plunger rod (61) (and thus the piston (68)) within the syringe barrel (69). The linear motion of the piston (68) can push out air bubbles and excess medicine through the syringe needle (66). Thus, the needle (66) can be primed by the torsional motion of the plunger rod (61) and prepared for injection. Once the thread (62) is fully moved through the thread (63), the size and configuration of the threads (62, 63) on both sides can be determined so that air is removed from the syringe barrel (69) and a predetermined volume of medicine is ejected from the syringe needle (66) and the needle (66) is primed.

[0061] The threads (62, 63) can also prevent the plunger rod (61) from being pressed before the priming of the needle (66) occurs. For example, to dispense medicine by pressing the plunger rod (61), the plunger rod (61) must be twisted first, that is, the needle (66) must be primed first. Once the thread (62) is rotated through the thread (63) and priming is complete, the user can press the plunger rod (61) to deliver the dose.

[0062] As discussed above in relation to FIG. 1. The embodiment of FIG. 5 may optionally include a magnifying glass (65). The magnifying glass (65) may assist in reading an enlarged volume measurement of the medicine within the syringe barrel (69), assist in observing the presence or absence of bubbles within the syringe barrel (69), and / or assist in determining whether a complete dose of the medicine has been dispensed from the syringe (60). The magnifying glass (65) may be included in the distal region of the syringe (60) and may have any suitable shape or size. For example, the magnifying glass (65) may have a circular or rectangular shape or may wrap around the entire or part of the circumference of the syringe barrel (69). In other embodiments, the magnifying glass (65) may not be included.

[0063] To operate the syringe (60), the user may first rotate the plunger rod (61). The plunger rod (61) may require a partial rotation, one full rotation, or more than one full rotation to pass the thread (62) through the thread (63) and to separate the thread (62) through the thread (63). At this point, the user may optionally check the dose level within the syringe barrel (69). If a magnifying glass (65) is included, the user may use the magnifying glass (65) to perform this step. Subsequently, the user may press the plunger rod (61) to dispense the drug dose.

[0064] In some embodiments, the syringe (60) may provide feedback to the user to indicate when the rotation of the plunger rod (61) is complete and the dose is ready to be injected. For example, a "click" sound or other auditory or tactile feedback mechanism may be included in the syringe (60).

[0065] The embodiments of FIGS. 6a through 6e may operate in a manner similar to the embodiment of FIG. 5, but may further include a restraining mechanism to prevent accidental pressure of the plunger rod (71) when the priming of the needle is completed. For example, FIGS. 6a through 6e, as in FIG. 5, include a thread (72) on the plunger rod (71) that must be twisted through the corresponding thread (73) of the syringe barrel (75). However, the plunger rod (71) may also include a stop (74) located on the outer surface of the plunger rod (71) arranged proximal to the thread (72).

[0066] The stopper (74) may have a size and shape to be assembled within a slot (76) that extends through the thread (73). For example, the stopper (74) may enter a vertical portion of the slot (76) that passes through a portion of the internal thread (73) of the syringe barrel (75) (e.g., shown in section AA of FIGS. 6b and 6c). The slot (76) may also include a horizontal section (e.g., along section BB of FIGS. 6b and 6d). Once the stopper (74) is fully slid into the vertical section of the slot (76), the user slides the stopper (74) through the horizontal portion of the slot (76) and rotates the plunger rod (71) in the opposite direction to the thread direction (72) of the plunger rod (71) to further advance the plunger rod (71) in a distal direction. Because an opposite rotational direction is required, the risk of accidental forward movement of the plunger rod (71) can be reduced. Finally, the plunger can be pressed downward to move the stop (74) through the second vertical section of the slot (76) (e.g., section CC shown in FIG. 6b and FIG. 6e) and release the volume of the medicine.

[0067] The slot (76) may be formed to rotate clockwise or counterclockwise depending on the relative positions of the horizontal and vertical sections. Additionally, although the slot (76) is illustrated and described as having one horizontal section that requires rotation of the rod (71), it is considered that it may have multiple horizontal sections that allow the rod (71) to rotate in the same direction or multiple directions a number of times. Also, although the stop (74) is illustrated as having two protrusions on the plunger rod (71), it is considered that one protrusion or more than two protrusions may be included as part of the stop (74), and the slot (76) may have a shape and size that accommodate different configurations of the stop (74).

[0068] Although the thread (73) is described as being on the inner surface of the syringe barrel (75), it is considered that the thread (73) and the slot (76) may be located on the inner surface of the finger flange in place of or in addition to the syringe barrel (75). Furthermore, as with all embodiments shown and described herein, the above-described embodiment may be combined with features of other embodiments described herein. For example, the rod (71) includes additional protrusions and / or shapes, as shown in FIGS. 4a through 4e and FIGS. 15a through 15e, to provide a strong stop for the movement of the rod (71).

[0069] Now, referring to FIGS. 7a and 7b, another embodiment of a dose release control mechanism is illustrated. In FIG. 7a, the syringe (80) includes paired helical threads (82, 83). In this embodiment, the outer thread (82) is located on a sleeve (87) surrounding the plunger rod (81) instead of being located directly on the plunger rod (81). An enlarged view of the threaded portion of the syringe (80) is shown in FIG. 7b. The sleeve (87) allows free distal movement of the plunger rod (81) (toward the needle end of the syringe (80)) but can block undesirable proximal movement of the piston (88). Before the plunger rod (81) is pressed, rotation of the sleeve (87) (e.g., by twisting the rod (85) located at the proximal end of the sleeve (87)) can be converted into controlled sliding motion of the sleeve (87) into the syringe barrel (89) through the threads (82) on the sleeve (87) and the finger flange (84) and / or the corresponding threads on the syringe barrel (89). The controlled sliding motion of the sleeve (87) can gradually press the plunger rod (81) and the stopper (88) toward the distal needle end of the device. Movement of the plunger rod (81) through the threaded area can allow for controlled air evacuation and priming of the needle (86).

[0070] As in the previous embodiment, the embodiment of FIG. 7a may also optionally include a magnifying glass (90). The magnifying glass (90) can magnify the volume measurement of the medicine in the syringe barrel (89), assist in observing the presence or absence of bubbles within the syringe barrel (89), and / or assist in determining whether a complete dose of the medicine has been dispensed from the syringe (80). The magnifying glass (90) may be contained within the distal region of the syringe (80) and may have any suitable shape or size. For example, the magnifying glass (90) may have a circular or rectangular shape or may wrap around the entire or part of the circumference of the syringe barrel (89). In other embodiments, the magnifying glass (90) may not be included.

[0071] To operate the syringe (80), the dial rod (85) may be rotated by a partial rotation, one full rotation, or more than one full rotation so that the thread (82) of the sleeve (87) passes through the thread (83) until the thread (82) separates from the thread (63). At this time, the user may optionally check the dose level within the syringe barrel (89). If a magnifying glass (90) is included, the user may use the magnifying glass (90) to perform this step. Subsequently, the user may press the plunger rod (81) to dispense the drug dose.

[0072] In some embodiments, the syringe (80) may provide feedback to the user to indicate when the rotation of the plunger rod (81) is complete and the dose is ready to be injected. For example, a “click” sound or other auditory or tactile feedback mechanism may be included in the syringe (80). In some embodiments, the user may be able to prevent further distal movement of the dial rod (85) by knowing that priming is complete because the dial rod (85) can no longer rotate, the plunger rod (81) can no longer move when twisted, and / or the dial rod (85) is adjacent to a portion of the finger flange (84) and / or syringe barrel (89).

[0073] In some embodiments, a restraining mechanism as described above with reference to FIGS. 6a through 6e may be included in the plunger rod (81). Before administration, the plunger rod (81) must be rotated (e.g., 90 degrees, even if the plunger rod (81) is rotated less or greater than 90 degrees) so that the plunger rod (81) can move freely, so that the plunger rod (81) can be prevented from being pressed distally during the needle priming process.

[0074] In another embodiment, a restraining or stopping mechanism may be included in the sleeve (87) of FIGS. 7a and 7b. Such a mechanism is illustrated in FIG. 8. If a stopping portion (91 and / or 92) (e.g., a tap or protrusion) is included on the sleeve (87) (e.g., above and / or below the thread (82) of the sleeve (87) and the thread (83) of the syringe barrel), the sleeve may be prevented from over-rotating in any direction (thus preventing excessive priming or unnecessary removal of the sleeve (87)). The stopping portion (91) may be located proximal to the thread (82) and configured to stop the movement of the sleeve (87) toward the distal end region of the syringe barrel. The stopping portion (92) may be located distal to the thread (82) and configured to stop the movement of the sleeve (87) toward the proximal end region of the syringe barrel.

[0075] Now, referring to FIGS. 9a through 9d, another syringe (100) is illustrated having an additional embodiment of a dose release control mechanism. This embodiment may include a key (103) that acts as a removable stop at the joint between the syringe barrel (109) and the plunger rod (101), for example. When the key is in place between the syringe barrel (109) and the proximal region of the plunger rod (101), the key (103) may obstruct the movement of the plunger rod (101). For example, during the packaging, filling, or preparation process of the syringe (100), the key (103) may be positioned between the plunger rod (101) and the syringe barrel (109). The key (103) may be set in place by a snap-fit, friction-fit, twist-fit, or other methods. Next, the user may remove the key (103) immediately before using the syringe (101). To remove the key (103), the user may remove the key (103) by pulling the tab included in the key (103), peeling off the tab, destroying the brittle part, twisting the key (103), or in an appropriate manner. The syringe (100) is illustrated as having a magnifying glass (105) arranged in the distal end portion of the syringe barrel (109), and the magnifying glass may assist in visualizing, for example, the level of the product within the barrel (109).

[0076] The above key and / or restraint mechanism may be useful in connection with a fillable syringe as well as a pre-filled syringe, and is considered to allow sterilization, packaging, storage, and / or transport to be performed after filling. In a pre-filled syringe, the key (103) can prevent accidental pressurization of the plunger rod (101) before intended use, thereby preserving the sterility, safety, and dose volume of the medicine. Variations of the key (103) may include a brittle stop that can be broken by applying a certain amount of force to the plunger rod (101), for example.

[0077] In addition to the key (103), the embodiment illustrated in FIG. 9a may include a restraining mechanism similar to the restraining mechanism discussed with respect to FIG. 4a through 4e and FIG. 15a through 15e below. For example, as illustrated in FIG. 9d, a slot (107) may be included in the stopper (104) of the syringe (100). The stopper (104) may have an opening (110) through which the plunger rod (101) can move without rotating to a set position. By means of the opening (110), the plunger can move a suitable distance for priming the priming needle (106). The slot (107) may have a size and shape for fitting the cross-sectional area of ​​the plunger rod (101) in a specific direction. For example, the plunger rod (101) may include a flange (102) having a size and shape for passing through the slot (107) when aligned with the slot (107). A stopper (104) may be arranged in a proximal region of the syringe barrel (109) so that the flange (102) must be rotated to a set position to align with the slot (107) before the plunger rod (101) is pressed through at least a portion of the stopper (104). Although the flange (102) and the corresponding slot (107) are illustrated, the slot (107) and the plunger rod (101) may have any suitable matching cross-sectional shape. Additionally, the plunger rod (101) may have a plurality of cross-sectional shapes along the length of the plunger rod so as to provide a strong stop for distal movement of the plunger rod (101) or to require additional rotation of the plunger rod (101) relative to the stopper (104) to further move the plunger rod (101) (see, for example, FIG. 15a through 15e). As with all embodiments shown and described herein, this embodiment may be combined with features of other embodiments described herein.

[0078] Once the key (103) is removed, the plunger rod (101) can be moved distally downward from its original position through the open portion (110) of the stopper (104). This distally moving of the plunger rod (101) may move the piston (108) only enough to prime the needle (106) and remove air bubbles. When the flange (102) contacts the inner portion of the stopper (104) at the position where the slot (107) begins, the stopper (104) may stop further distally moving the plunger rod (101). At that time, the plunger rod (101) is rotated, and the flange (102) must be aligned with the slot (107) of the stopper (104) before the rod (101) can be pressed distally through the rest of the stopper (104) to move the piston (108) and discharge the drug dose.

[0079] In some embodiments, the syringe (100) may be configured to provide feedback to the user to indicate when the plunger rod (101) and flange (102) are aligned with the slot (107) and / or when the priming of the syringe (100) is complete. For example, a "click" sound or other auditory or tactile feedback mechanism may be included in the syringe (100).

[0080] Now, referring to FIGS. 10a through 10c, a cross-sectional image of a syringe (200) is shown along with various embodiments of additional dose release control mechanisms. The syringe (200) may include a barrel (240) and a plunger rod (220). The plunger rod (220) may be coupled to a first plunger (222) which may be configured to be assembled into an opening of a flange (210) located at the proximal end of the plunger rod of the barrel (240). The flange (210) may be configured to be tightly assembled inside the barrel (240) and may be sealed against the interior of the barrel (240), for example, with an O-ring (208). A first fluid (244) may be arranged on the proximal side of the plunger (260) inside the barrel (240), and a second fluid, for example, a medicine (212), may be arranged on the distal side of the plunger (260) inside the barrel (240). A needle, cannula, tube, or other attachment through which the fluid, for example, the medicine (212), can be discharged or withdrawn may be attached to the distal end of the barrel (240).

[0081] The opening of the flange (210) may have a cross-sectional width (a) such that the plunger (222) can be configured to be tightly assembled. In some embodiments, the plunger (222) may be configured to form a seal on the flange (210), for example, using an O-ring (224). The portion of the flange (210) having the width (a) may also have a depth (c). As illustrated in FIG. 10a, in some embodiments, the depth (c) may correspond to the distance between the distal side of the plunger (222) and the distal side of the flange (210). For example, a first volume of fluid (244) within the opening of the flange (210) may be distally displaced by a distance corresponding to a depth (c) by the distal movement of the plunger (222) for a distance corresponding to a depth (c) (e.g., caused by the pressure of the plunger rod (220) toward the flange (210). Next, the displacement of the first volume of fluid (244) may push the plunger (260) so that a second volume of medicine (212) may be discharged from the syringe (200). The barrel (240) may be located distal from the flange (210) and may have a cross-sectional width (b), and the width (b) is greater than the width (a). Due to the difference in widths (a and b) (and thus, the difference in fluid volume capacity in the portion of the syringe (200) having widths (a and b)), for example, a distal movement of the plunger (222) by a distance corresponding to the depth (c) can cause the plunger (260) to move distally by a smaller distance (d). In this way, for example, the movement of the plunger rod (220) in the distal (or proximal) direction can be converted into a proportionally smaller, and therefore more controllable, movement of the plunger (260) and thus into a more controllable discharge (or extraction) of the volume of the medicine (212).

[0082] The embodiments illustrated in FIG. 10b and FIG. 10c may differ slightly from the embodiment of FIG. 10a. Referring to FIG. 10b, the cross-sectional widths (a and b) may be the width of the opening of the flange (210). In this embodiment, the second plunger rod (262) may be arranged within the barrel, so that a portion of the plunger rod (262) is arranged within a portion of the flange (210) having width (b) and crosses the interior of the flange. The plunger rod (262) may be coupled to the plunger (260) and may extend proximately from the plunger. Additionally, the plunger rod (262) may have a proximal side that extends across the area of ​​the opening of the flange (210) having width (b), so that the distal movement of the fluid (244) causes distal movement of the plunger rod (262) and subsequently pressurizes the plunger (260) distally. Referring to FIG. 10c, the cross-sectional width (b) may represent the internal cross-sectional width of the barrel (240) as in the embodiment shown in FIG. 10a, and the second plunger rod (262) may be arranged inside the barrel and may extend across the interior of the barrel (240). Similar to the embodiment shown in FIG. 10b, the plunger rod (262) may have a proximal portion extending across the internal area of ​​the barrel (240) having width (b), so that distal movement of the fluid (244) may cause distal movement of the plunger rod (262) and subsequently distal pressurize the plunger (260). As in the embodiment of the syringe (200) shown in FIG. 10a, for example, the movement of the plunger rod (220) in the distal direction is converted into a proportionally smaller and more controllable movement of the plunger (260), and thus the volume of the medicine (212) can be discharged more controllably.

[0083] For the embodiments illustrated in FIGS. 10b and 10c, the plunger rod (262) may form a seal with an adjacent portion of the syringe (200) so that the fluid (244) cannot move distally through / by the plunger rod (262). As a result, a relatively small amount of fluid (244) may be required, and a "empty" space area between the fluid (244) and the medicine (212) may be allowed to help prevent the fluid (244) from leaking or mixing with the medicine (212). The "empty" space may contain a vacuum, for example, dry or sterile air. In some embodiments, the "empty" space may contain additional fluid (244) (or other fluid) to provide additional structural support to the syringe. In any embodiment illustrated in FIGS. 10a through 10c, the fluid (244) may be any suitable liquid or gaseous fluid, for example, water for injection, dry gas, sterile air, etc.

[0084] Referring to FIG. 11a, a cross-section of another syringe (300) having an additional embodiment of a dose release control mechanism is shown. The syringe (300) may include a barrel (340), a plunger (360), and a medicine (312). The plunger rod (320) may extend into the barrel (340) and may include a number of ratchet-shaped teeth (321) that may engage with a pinion (328), and the pinion may then engage with a ratchet-shaped tooth (326) inside the barrel (340). Each pinion (328) may be coupled to one of the rods (330) that may be coupled to the plunger (360). A needle, cannula, tube, or other attachment (not shown) may be attached to the distal end of a barrel (340) from which a fluid (e.g., medicine (312)) can be discharged or removed.

[0085] Movement of the plunger rod (320) in the proximal or distal direction can be converted into a proportionally smaller movement of the plunger (360) through the pinion (328) and the tooth portion (326). In this way, the controlled movement of the plunger (360) in the distal direction can, for example, eject the medicine (312) distally with a controlled speed. The size and shape of the tooth portion, ratchet, and pinion within the syringe (300) can be selected to produce a desired controlled movement speed of the plunger (360).

[0086] In FIG. 11b, which illustrates a cross-sectional view of another embodiment of the syringe (300), the tooth portion (321) of the plunger (320) can be engaged with the pinion (328), and the pinion can be engaged with a relatively smaller pinion (329) and rotate coaxially and parallelly, and the pinion can then be engaged with the tooth portion (326) inside the barrel (340). The pinion (328) can pass adjacent to the tooth portion (326), so that only the pinion (329) can be engaged with the tooth portion (326). Each pinion (328, 329) can be coupled to one of the rods (330) that can be coupled to the plunger (360).

[0087] Due to the diameter of the pinion (329) being relatively smaller than that of the pinion (328), the movement of the plunger (320) in the proximal or distal direction can be converted into a proportionally smaller movement of the plunger (360) through the pinion (328), the pinion (329), and the tooth portion (326). In this way, the controlled movement of the plunger (360) in the distal direction can be converted, for example, into a relatively small movement of the plunger (360) and into a distally controlled discharge of the medicine (312). As shown in FIG. 11a, the size and shape of the tooth portion, ratchet, and pinion within the syringe (300) can be selected to form a desired controlled movement speed of the plunger (360).

[0088] The embodiments illustrated in FIG. 11a and FIG. 11b each illustrate a symmetrical arrangement comprising teeth (321), two pinions (328), (for the embodiment of FIG. 11b) two pinions (329) and two rods (330) on two sides of a plunger rod (321), but a single arrangement, e.g., teeth (321) coupled with one pinion (328) coupled to one pinion (329) coupled to one rod (330) (for the embodiment of FIG. 11b), is also considered. Those skilled in the art will understand that more or fewer pinions and / or rods may be included in the embodiments of this disclosure to achieve controlled delivery of the contents of the syringe (300).

[0089] Now, referring to FIG. 12, a cross-sectional view of another syringe (400) having an additional embodiment of a dose release control mechanism is shown. The syringe (400) may include a barrel (402), an inner sleeve (404), and a plunger rod (406). The plunger rod (406) may extend into the barrel (402) and into an opening (410) formed by the inner sleeve (404), the opening (410) being narrower than the general inner width of the barrel (402). The opening (410) may receive or contain a drug (408).

[0090] Generally, the syringe (400) is configured to provide a relatively narrow channel or path (e.g., inside the opening (10)) through which the medicine (408) can be pressurized by the plunger rod (406), so that the distal movement of the plunger rod (406) can be converted into a relatively gradual and controllable discharge or delivery of the medicine (408) through the distal end of the syringe (400) (e.g., through a needle, cannula, tube, or other attachment attached to the syringe (400)) compared to a syringe having a channel or path for the medicine (408) having a relatively wide width.

[0091] As illustrated, the distal portion of the plunger rod (406) may be configured to be fitted into the opening (410) of the inner sleeve (404). The inner sleeve (404) may be a portion having the barrel (402) (e.g., adjacent to the barrel (402) or manufactured within a single mold with the barrel) or a separate portion inserted into the barrel (402). The inner sleeve (404) may extend partially or completely through the interior of the barrel (402). In some embodiments, as illustrated, the inner sleeve (404) may be arranged within the distal portion inside the barrel (402).

[0092] The plunger rod (406) may be assembled to, coupled to, or otherwise contact a plunger configured to surround a certain amount of medicine (408) within the opening (410) and / or between the plunger rod (406) and the distal end of the syringe (400). The plunger rod (406) and / or the plunger coupled to the plunger rod (406) may be configured to be assembled within the barrel (402) so as to generally accommodate the medicine (408) within the barrel (402) without leakage of the medicine (408) (e.g., proximal to the inner sleeve (404)). The opening (410) and the plunger rod (406) may be configured to have a relatively narrow width, thereby forming a relatively narrow channel through which the medicine (408) can be discharged from the syringe (400).

[0093] In some embodiments, the barrel (402) may be marked with a measuring indicator to visually indicate the volume of fluid remaining in the syringe (400) and / or dispensed from the syringe. Additionally, as illustrated or described in relation to other embodiments, the syringe (400) may optionally include a magnifying glass attached to or built into the syringe barrel (402) to assist in reading the measuring indicator on the syringe barrel (102), assist in observing the presence or absence of bubbles inside the syringe barrel (102), and / or assist in determining whether a full dose of the medicine (408) has been dispensed from the syringe (400). Such a magnifying glass may be included in the distal region of the syringe (10) and may have any suitable shape or size. In other embodiments, the magnifying glass (11) may not be included.

[0094] In another embodiment, the narrow channel of the syringe (400) can be achieved in a manner that does not require an inner sleeve (400). For example, the syringe barrel (e.g., barrel (402)) is manufactured to have a relatively narrow interior configured to accommodate a plunger rod (406), so that a narrow insert needle does not need to be arranged inside the barrel. The narrow interior of the syringe barrel may be sized and structured to accommodate a certain volume of medicine (e.g., medicine (408)) so that a desired or appropriate amount of medicine is dispensed from the syringe (400) upon use.

[0095] Features of the embodiment illustrated in FIG. 12 may be suitable for combination with features of other embodiments discussed herein. For example, any embodiment of this disclosure may also include a relatively narrow (or narrowed) interior to allow for more gradual and controlled delivery of the drug.

[0096] Now, referring to FIGS. 13a through 13c, a cross-sectional view of another syringe (420) having an additional embodiment of a dose release control mechanism is shown. The syringe (420) may include a barrel (422), a plunger rod (424), and a plunger (426). The interior (428) of the barrel (422) may receive or accommodate a drug (430) and an insert (432).

[0097] The insert (432) may include a compressible portion so that the insert (432) can be compressed by a predetermined distance or volume. In some embodiments, for example, the insert (432) may be a spring such as a wave spring, a coil spring, or other springs known in the art. In additional embodiments, for example, the insert (432) may be made of a compressible material such as rubber, silicone, or plastic. In some embodiments, the insert (432) may be attached to a specific position / direction of the barrel (422) or otherwise fixed in place.

[0098] The initial configuration of a filled syringe (420) is illustrated in FIG. 13a. In this configuration, a certain amount of medicine (430) is located between the plunger (246) and the insert (432), such as in the empty space (e.g., bubble) inside (428). As illustrated in FIG. 13b, when the plunger rod (424) is pressed distally, the amount of medicine (430) between the plunger (426) and the insert (432) can be discharged distally from the syringe (420) along with bubbles (e.g., through a needle, cannula, tube, or other attachment connected to the distal end of the syringe (420). When in contact with the plunger (426), the insert (432) may provide some resistance to further distally movement of the plunger (426). Accordingly, for example, tactile, auditory, and / or visual feedback indicating that the syringe (420) has been primed and air bubbles removed can be provided to the user of the syringe (420).

[0099] The distance over which the insert (432) can be compressed may be proportional to the volume of the drug (430) suitable for the dose contained within the barrel (422). For example, in some embodiments, the volume defined by the insert (432) includes the volume of the drug (430) suitable for the dose contained within the barrel (422). Thus, as illustrated in FIG. 13c, when the plunger (426) moves further distally to compress the insert (432) by a distance (a), a certain amount of the drug (430) suitable for the dose may be dispensed from the distal end of the syringe (420). For example, the plunger (426) may be moved distally so that a volume of the drug (430) corresponding to the volume defined by the insert (432) is dispensed. The insert (432) is configured to prevent compression or movement beyond a distance (a) to ensure that only a certain amount of medicine (430) suitable for the dose is dispensed. The remaining amount of medicine (430) may remain inside the barrel (422) after the dosage has been dispensed. Thus, dose accuracy can be increased because there is no need for interaction between the plunger (426) and the tapering of the barrel (422) diameter, which may occur in some cases near the distal end portion of the syringe (420).

[0100] Now, referring to FIGS. 14a through 14c, a cross-sectional view of another syringe (440) having an additional embodiment of a dose release control mechanism is shown in three steps. The syringe (440) may include a plunger having an outer plunger rod (444) and an inner plunger rod (446) that can be actuated by a barrel (442), a knob, or a depressor (448). The inner plunger rod (446) may be arranged within the outer plunger rod (444) and may be arranged coaxially. The inner plunger rod may protrude proximally and / or distally from the outer plunger rod (444). A plunger (450) may be coupled to one or both of the inner plunger rod (446) and the outer plunger rod (444). Specifically, the plunger (450) may be movably coupled to the inner plunger rod (446). A certain volume of pharmaceutical (454) may be received or introduced into the barrel (442) between the plunger (450) and the distal end of the syringe (440). The insert (456) may be arranged, for example, distal from the plunger (450) at the distal end. The insert (456) may include a channel (458) sized and structured to receive an internal plunger rod (446) (rather than the plunger (450) or the external plunger rod (444)).

[0101] As illustrated in FIG. 14a, the inner plunger rod (446) may extend both proximally and distally from the outer plunger rod (444). A seal (not shown) may exist between the inner plunger rod (446) and the outer plunger rod (444) to prevent fluid leakage between the plunger rods. In some embodiments, the inner plunger rod (446) may extend only distally or only proximally from the outer plunger rod (444). For example, the inner plunger rod (446) may be a telescoping plunger rod configured to extend only distally from the outer plunger rod (444). In some embodiments, the inner plunger rod (446) may optionally be configured to fold in multiple stages, slide, or move through the outer plunger rod (444) and the plunger (450). In some embodiments, for example, the inner plunger rod (446) is configured to engage with a thread configured to engage with a paired thread on the outside (not shown in the drawing) of the outer plunger rod (444) (not shown in the drawing) on ​​the inside. When the inner plunger rod (446) and the outer plunger rod (444) are joined through said thread or by any other mechanism, the inner plunger rod (446) and the outer plunger rod (444) can move proximally and distally side by side within the barrel (442). When the inner plunger rod (446) is rotated relative to the outer plunger rod (444) (e.g. by rotating the rotary knob or depressor (448)), the inner plunger rod (446) may be configured or allowed to move proximally or distally independently of the outer plunger rod (444), and in particular in some embodiments, may be allowed to move distally through the outer plunger rod (444) and the plunger (450).In some embodiments, the plunger (450) may be attached to the distal end of the outer plunger rod (444) so ​​that the inner plunger rod (446) can move through the plunger rod (444) and the plunger (450) without being separated between the outer plunger rod (444) and the plunger (450). In other embodiments, the distal end of the outer plunger rod (444) may simply contact or press against the plunger (450).

[0102] The initial configuration of the syringe (440) is illustrated in FIG. 14a. As illustrated, the inner plunger rod (446), the outer plunger rod (444), and the plunger (450) are all positioned proximally from a certain amount of medicine (454) contained within the barrel (442). As illustrated in FIG. 14b, when the depressor or knob (448) is pressed, the inner plunger rod (446) and the outer plunger rod (444) can move distally through the barrel (442), and consequently, the plunger (450) can be pressurized through the barrel (442). Thus, the syringe can be primed to remove air and excess medicine (454) from the barrel (442) by releasing air and excess medicine, for example, through the distal end of the barrel (442) (e.g., through a needle, cannula, tube, or other attachment at the distal end of the barrel (442)). The distal movement of the plunger rod (444, 446) and the plunger (450) can eventually be stopped by contact between the plunger (450) and the insert (456). Thus, tactile, auditory, and / or visual feedback indicating that priming is complete can be provided, for example, to the user.

[0103] As illustrated in FIG. 14c, the inner plunger rod (446) can then be moved independently and distally from the outer plunger rod (444) by, for example, rotation of the inner plunger rod (446) so that the inner plunger rod (446) is separated from the outer plunger rod (444). In some embodiments, by this rotation, for example, the outer screw of the inner plunger rod (446) can be separated from the inner screw of the outer plunger rod (444). In some embodiments, by this rotation, the inner plunger rod (446) may be allowed to expand distally (e.g., telescoping). Next, the inner plunger rod (446) can be moved distally through a channel (458) which may contain a volume of medicine (454) suitable for the dose amount. In this manner, the internal plunger rod (446) may be configured to release a desired dosage of medicine (454) through the distal end of the barrel (442). In some embodiments, the distal end of the internal plunger rod (446) may have a size and structure to move distally through the channel (458) and may include, be attached to, or fixed with an internal plunger capable of pressurizing a volume of medicine (454) suitable for the dose toward and through the distal end of the barrel (442).

[0104] Now, referring to FIGS. 15a through 15e, drawings of another syringe (500) having additional embodiments of a dose release control mechanism are shown. The syringe (500) may include a plunger rod (503) and a barrel (502) having a handle or depressor (504) and protrusions (506, 508) extending in directions offset from each other. The plunger rod (503) also includes a stopper (510). The proximal end of the barrel (502) is covered by a keyhole-shaped flange (512) (a plan view is shown in FIG. 5e). A plunger (514) is arranged inside the barrel (502) so that it can be contacted and pressed distally by the plunger rod (503). The interior of the barrel (502) can also accommodate a volume of medicine (516) arranged distally from the plunger (514).

[0105] The initial configuration of the syringe (500) is illustrated in FIG. 15a. As illustrated, the plunger rod and plunger (514) are positioned proximal to the volume of the medicine (516). A protrusion (506) extending from the distal end portion of the plunger rod (503) is positioned to engage through the keyhole shape of the flange (512), so that the plunger rod (503) can move distally until the flange (512) contacts the protrusion (508) (Fig. 15b). The size of the distally movement allowed in this configuration may be sufficient to prime the syringe (500) and remove air between the plunger (514) and the medicine (516). As illustrated in FIG. 15b, the plunger rod (503) may be prevented from moving further by contact between the protrusion (508) and the flange (512), which may have a shape and size similar to the protrusion (506) but a different configuration (e.g., rotational offset configuration) from the protrusion (506).

[0106] FIG. 15c illustrates a syringe (500) when the plunger rod (503) is rotated 90 degrees. In this configuration, the protrusion (508) can be fitted through the flange (512) as shown in FIG. 15d. Next, the plunger rod (503) can move distally until the movement of the plunger rod is stopped by a stopper (510) which may have a shape and / or size not configured to assemble the flange (512) in any direction. The movement of the plunger rod (503) as shown in FIG. 15c through 15d can dispense a volume of medicine (516) equivalent to a suitable or desired dose to the patient (e.g., by a needle, cannula, tube, or other attachment to the distal end of the syringe (500). Although the plunger rod (503) is shown rotating 90 degrees between FIG. 15c and FIG. 15d, it is understood that the protrusions (506 and 508) can be rotated offset by any appropriate size.

[0107] In some embodiments, as illustrated in FIG. 15d, when dispensing a desired or appropriate volume of medicine (516), the plunger (514) may not be located coplanar with the distal end inside the barrel (502), and the volume of medicine (516) may remain in the barrel (502). In some embodiments, this may allow for increased accuracy of the dose volume delivered from the syringe (500) because the discrepancy in size or shape between the stopper (514) and the distal end of the barrel (502) does not prevent the desired or appropriate dose volume from being dispensed. Additionally, this (and other embodiments of the specification) may eliminate the need for a dose line on the syringe (500), thereby reducing or eliminating inaccuracies that may occur when arranging a dose line on the barrel (502) during the manufacturing process and / or when visually measuring whether the volume of medicine (516) is aligned with the dose line on the barrel (502).

[0108] Although the protrusions (506, 508) are depicted as having a specific shape and size, it should be noted that the protrusions and the corresponding openings in the flange (512) may have any suitable shape and size that allow the protrusions (506, 508) to pass through the flange (512). Additionally, although the flange (512) is depicted as having an opening,

[0109] It should be noted that any part of the syringe (500) may include an opening suitable for controlling the movement of the plunger rod (503) (e.g., into a finger flange, a proximal end portion of the barrel (502), a proximal side portion of the barrel (502), or any other suitable part of the syringe (500).

[0110] Now, referring to FIGS. 16a through 16e, drawings of another syringe (600) having additional embodiments of a dose release control mechanism are shown. The syringe (600) may include a barrel (602) and a plunger rod (603) having a depressor (604) and a protrusion (606). A plunger (608) is arranged inside the barrel (602). A removable key (610) is arranged at the proximal end of the barrel (602). The interior of the barrel (602) may also accommodate a certain volume of medicine (612). The proximal end of the barrel (602) may be closed or sealed in any suitable manner and has an opening configured to pass a thin portion of the plunger rod (603).

[0111] In some features of this embodiment, the protrusion (606) may have a size and configuration such that it cannot pass over the key (610). Thus, the plunger rod (603) may be pressed distally until the protrusion (606) contacts the key (610). The protrusion (606) may be fixed to the plunger rod (603) in any suitable manner, or may be a part of the plunger rod (603) (e.g., formed as part).

[0112] In some embodiments, the key (610) may be manufactured as a structure separated from other features of the syringe (600). In additional embodiments, the key (610) may be integral with other parts of the syringe (600), such as a removable finger flange (not shown in the drawing), for example.

[0113] The initial configuration of the syringe (600) is illustrated in FIG. 16a. As illustrated, the plunger rod (603) and the plunger (608) are arranged proximally to the volume of the medicine (612) arranged inside the barrel (602). The protrusion (606) is located proximally to the key (610). As illustrated in FIG. 16b, the plunger rod (603) can move distally (e.g., through the pressing of the depressor (604)) until the protrusion (606) contacts the key (610). The size of the distally movement allowed in this configuration may be sufficient to prime the syringe (600) and remove air between the plunger (608) and the medicine (612). As illustrated in FIG. 16b, further movement of the plunger rod (603) may be prevented by contact between the key (610) and the protrusion (606).

[0114] FIG. 16c illustrates the syringe (600) when the key (610) is removed. Once the key (610) is removed, the height of the key (610) is proportional to the desired or appropriate dosage of the medicine (612). Once the key (610) is removed, the plunger rod (603) and the protrusion (606) can move more distally and freely until the protrusion (606) contacts another part of the syringe (600) located at the proximal end of the barrel (602) (Fig. 16d) or the distal end of the barrel (602) (e.g., flange, cap, or stopper) and is obstructed by the part. This movement of the plunger rod (603) allows the plunger (608) to likewise release the desired or appropriate dose of the medicine (612) (e.g., through a needle, cannula, tube, or other device connected to the distal end of the syringe (600).

[0115] Now, referring to FIGS. 17a and 17b, two schematic diagrams relating to additional embodiments of a delivery device having a dose release control mechanism are shown. FIG. 17a shows a syringe (700a) having a body (702), a plunger rod (704) having a plurality of teeth, a plunger (706), and a certain volume of medicine (708). The teeth of the plunger rod (704) may be configured to engage with the paired teeth of an intermediate gear (712) which may be configured to engage with the teeth of a drive gear (714a). The drive gear (714a) is shown having two longer teeth configured to engage with a tap on an offset actuator (710a).

[0116] Primeing and dispensing a dose from a syringe (700a) can be achieved by applying pressure (e.g., a first pressure position and a second pressure position) of an offset actuator (710a). The tab of the offset actuator (710a) may have the size and structure to interact (e.g., pressurize) with the long teeth of the drive gear (714a) at desired intervals corresponding to the priming of the syringe (700a) (lower tab and the first tooth of the long teeth of the drive gear (714a) and the dispensing of a desired dose of medicine (708) (upper tab of the actuator (710a) and the second tooth of the long teeth of the drive gear (714a)). FIG. 17a illustrates, for example, the position of the drive gear (714a) and the actuator (710a) (e.g., the first pressurized position) after the syringe (700a) has been primed. In some embodiments, the drive gear (714a), intermediate gear (712), or plunger rod (704) may provide auditory, visual, or when moving the actuator (710a) to the first or second pressurized position. It may be configured to provide tactile feedback (e.g., providing a click sound or motion resistance beyond a pressure position). In some embodiments, the interaction between the actuator (710a) and the drive gear (714a) may be similar to the interaction of a Geneva drive. In some embodiments, the rotation of the drive gear (714a) may be stopped by contact between the intermediate gear (712) and the long tooth of the drive gear (714a).

[0117] Multiple configurations of the drive gear and actuator are possible to achieve the priming and / or drug dispensing steps by pressurizing the actuator. For example, FIG. 17b illustrates a second syringe (700b) having a drive gear (714b) having three long teeth instead of two and an actuator (710b) having three taps instead of two. In this embodiment, it is considered that the actuator (710b) can be pressurized multiple times (e.g., to a first depth, a second depth, and a third depth) to achieve the desired result (e.g., priming of the syringe (700b)). Each contact between the tap of the actuator (710b) and the long tooth of the drive gear (714b) may entail tactile, auditory, or visual feedback and may correspond to a partially or fully primed syringe (700b) to remove bubbles from the syringe (700b) or to dispense a volume of a desired dose from the syringe (700b). In some embodiments, the actuator may have only one tap configured to interact with the long teeth of the drive gear (e.g., refer to the actuator (710c) and drive gear (714c) shown in FIG. 17c).

[0118] In some embodiments, the actuator has a spring load so that after the actuator is pressed to a predetermined size (e.g., sufficient for the actuator's tap to press, contact, rotate, and / or otherwise interact with a long single tooth of the drive gear), the actuator can be returned to a pre-pressed position, for example, by spring return or other return mechanism. Such an embodiment is schematically illustrated in FIG. 17c, where the pressing of the actuator (710c) can compress the spring (716), and then the actuator (710c) can be returned to a pre-pressed position upon release. When the actuator (710c) is pressed again to a predetermined size, the actuator's tap (710c) can press, contact, rotate, and / or otherwise interact with another long single tooth of the drive gear. Each pressurization of the actuator can provide a separate function (e.g., priming and / or removing air from the syringe, or dispensing an appropriate dose from the syringe).

[0119] FIGS. 17a through 17c illustrate potential forms of embodiments including a drive gear and an actuator, and more permutations and combinations of a drive gear having longer teeth and an actuator having a tap are considered. According to further variations of these embodiments, for example, the actuator (e.g., actuator (710c)) may have a spring load or be otherwise configured in any suitable manner so that it returns to an initial position after completing a priming or dispensing step.

[0120] Now, referring to FIGS. 18a through 18f, drawings of other embodiments of the dose release control mechanism are shown. FIGS. 18a and FIGS. 18b respectively show a front view and an angle view of a sleeve (800). The sleeve (800) may be configured to surround and / or attach, for example, a syringe barrel and may include a body (801), a channel (802), a flange (804), and an offset portion (806) of the channel (802). The sleeve (800) may be configured to be used with a plunger rod (820), for example, shown in FIG. 18c. The plunger rod (820) may include a first body (822) extending from a cap (826). The first body (822) may be configured to extend into the body of the syringe barrel. A plunger rod pin arm (824), which can extend from the cap (826) separately from the first body (822), may be configured to extend adjacent to the syringe barrel to which the first body (822) extends. A plunger rod end (828) may be configured to contact, secure, or otherwise attach to a plunger (not shown).

[0121] FIG. 18d illustrates a syringe assembly (830) comprising a sleeve (800) surrounding a syringe (832) and a plunger rod (820). As illustrated, the plunger rod pin arm (824) may have the size and structure to slide through the channel (802). As the plunger rod (820) is pressed distally into the body of the syringe (832), the plunger rod pin arm (824) may move distally through the channel (802). When the plunger rod pin arm (824) reaches the offset portion (806) of the channel (802), the shape of the channel (802) may stop further distally movement of the plunger rod (820). According to FIG. 18e, when the plunger rod (820) rotates (e.g., the cap (826) rotates) or when the plunger rod pin arm (824) moves or rotates individually, the plunger rod pin arm (824) can move laterally into the offset portion (806) of the channel (802), and then further distal movement of the plunger rod pin arm (824), and thus the plunger rod (820), can be made possible.

[0122] The syringe (832) may contain a volume of medicine greater than the desired dose for the patient. To prime the syringe (832), an initial distal movement of the plunger rod (820) (e.g., before the plunger rod pin arm (824) approaches the offset portion (806) of the channel (802)) may be utilized. Near the offset portion (806) of the channel (802) (e.g., illustrated in FIG. 18e), the shape change of the channel (802) and contact of the plunger rod pin arm (824) may indicate that the syringe is primed and air is removed from the inside of the syringe (832). The length of the offset portion (806) of the channel (802) may be proportional to the desired dose volume of the medicine inside the syringe (832) after the syringe (832) is primed. Thus, by rotating the plunger rod (820) to align the plunger rod pin arm (824) with the offset portion (806) of the channel (802) and continuing to press the plunger rod (802) so that the plunger rod pin arm (824) slides through the offset portion (806), the desired dose of the medicine can be delivered through the distal end of the syringe (832) (e.g., shown as being coupled to a needle in FIG. 18e and FIG. 18f).

[0123] FIG. 18f illustrates a detailed side cross-sectional view of the assembly (830). The plunger rod pin arm (824) is shown in contact with the portion of the channel (802) where the offset portion (806) begins. Thus, the assembly (830) may be in a "primed" position. The interior (834) of the syringe (832) shown in FIG. 18f may correspond to the desired dose volume of the medicine delivered to the patient.

[0124] Now, referring to FIGS. 19a through 19e, drawings of another embodiment of a dose release control mechanism are shown. The assembly (900) may include a syringe body (902), a plunger rod (904a), a plunger (906), a plunger rod pin arm (908), and a sleeve (910a) that can be connected to a syringe flange (912). The syringe body (902) may receive a certain volume of medicine (914) arranged distally from the plunger (906). The operation of this embodiment may be similar to the operation of the assembly (830) shown in FIGS. 18a through 18f. In particular, the sleeve (910a) does not need to extend along the entire length of the syringe body (902) so as to allow visibility into the syringe body (902) or, if the syringe body (902) is transparent. The length of the sleeve (910a) (and / or other parts of the assembly (900)) may be selected, for example, to assist in easy handling of the assembly (900).

[0125] As illustrated in FIGS. 19a through 19d, various configurations of sleeves and channels within the sleeves can be used with the assembly (900) to prime and dispense a desired dose of medicine from the assembly (900). For example, the sleeve (910a) illustrated in FIG. 19a includes a channel (909a) that does not extend through the entire sleeve (910a). In this embodiment, the upper portion of the channel (909a) may correspond to the distance that the plunger rod pin arm (908) and thus the plunger rod (904a) can move to prime the assembly (900), and the offset lower portion of the channel (909a) may be proportional to the desired dose volume of medicine (914) that can be dispensed from the distal end of the assembly (900) by the rotation and distal movement of the plunger rod (904a) until the plunger rod pin arm (908) is blocked from further distal movement by the end of the channel (909a). The closed end of the channel (909a) ensures that a volume exceeding the desired dose is not delivered and prevents the plunger (906) from moving distally into the tapered distal end portion of the syringe body (902), thereby mitigating, for example, changes in the desired dose. The above change may be caused, for example, by a change in the geometric structure of the plunger (906) and the syringe body (902).

[0126] In an optional embodiment, the sleeve may have a different configuration as shown in FIGS. 19b through 19d. The sleeve shown in the cross-sectional view of FIGS. 19b through 19d has a variation of a channel through which the plunger rod pin arm (908) can move and thus guide the movement of the plunger rod (904a) within the syringe body (902). FIG. 19b shows a front view of a half sleeve (910b). The half sleeve (910b) may not wrap around the syringe body (902) to form a narrow channel through which the plunger rod pin arm (908) can move; instead, the plunger rod pin arm (908) may be guided by the "open" wall of the half sleeve (910b) and may move within an area (909b) adjacent to the open wall of the half sleeve (910b). The sleeve (910c) illustrated in FIG. 19c provides a configuration similar to the sleeve (910a), except for the open end of the channel (909c), as opposed to the closed end of the channel (909a). This configuration may allow, for example, the bottom formation of the plunger (906) within the syringe body (902), and in the embodiments, this bottom formation may dispense a desired dose of medicine from the assembly (900). The sleeve (910d) illustrated in FIG. 19d shows a channel (909d) having a bend opposite to the bend of the sleeves (910a, 910b, and 910c).

[0127] FIGS. 19a through 19d illustrate an exemplary configuration of a channel through which a plunger rod pin arm can move. However, it is considered that more embodiments of the sleeve and / or channel are possible. Although the channel (909a) is depicted as being arranged distally from the sleeve flange (912), the channel (e.g., channel (909a, 909b, 909c, or 909d) may be contained in or in any part of the syringe body (e.g., syringe body (902)) and / or may be contained in the syringe body itself (e.g., through embossing, carving, molding, or other methods).

[0128] FIG. 19e illustrates an exemplary method or mechanism by which a sleeve (910C) and a sleeve (e.g., sleeve (910c)) can be connected to a flange portion (912) during the assembly process. As illustrated, the sleeve (910c) may include one or more tabs (915) that may intersect with a paired slot, hole, or recess (913) within the flange (912). The interface between the tab (915) and the slot, hole, or recess (913) within the flange (912) may be any suitable interface that allows the connection of the flange (912) and the sleeve (910c) (e.g., dovetail connection, dowel connection, mortise and tenon connection, or other types of connection currently known or to be developed in the future). In an optional embodiment, the flange (912) may be connected to the sleeve (910c) without using the tab, slot, hole, or recess (e.g., using adhesive, thermal connection, etc.).

[0129] In this way, the attachment of the flange and the sleeve allows one of the two parts to be added to the syringe body (902) first, and then the other part to be added. For example, the flange (912) may be configured to slide, surround, snap-on connect, or otherwise join the syringe body (902), and then the sleeve (e.g., sleeve (910a, 910b, 910c, or 910d)) may slide on the syringe body (902) and be connected to the flange (912). As another example, the sleeve may be added to the syringe body (902) first and then to the flange (912). In yet another example, the sleeve and the flange (912) may be connected to the syringe body (902) first, and then slide, surround, snap-on connect, or otherwise connected.

[0130] In additional embodiments, the sleeve (e.g., sleeve (910a, 910b, 910c, or 910d)) and the flange (e.g., flange (912)) may be a single body (e.g., manufactured or molded together) instead of comprising two attachment parts. In some embodiments, the sleeve and / or flange may be made of a material having sufficient rigidity for the sleeve's channel to restrict and / or control the movement of the plunger rod pin arm, and sufficient flexibility for the sleeve and / or flange to be snap-on connected or otherwise connected to the syringe body (902). In some embodiments, for example, the sleeve and / or flange may comprise polypropylene. In some embodiments, for example, the sleeve and / or flange may comprise two different materials (e.g., polypropylene and a second material) that are joined in an overmolding technique.

[0131] Now, with reference to FIGS. 20a through 20c, drawings of other embodiments of a dose emission control mechanism are illustrated. Three drawings are discussed together in this specification. As shown primarily in the cross-sectional view of FIG. 20a and the cross-section labeled "AA" in FIG. 20b, the assembly (1000) may include a plunger rod (1002), a plunger (1003), a syringe body (1004), a volume of a drug (1005) arranged within the syringe body (1004), a plunger rod (1002), a sleeve (1008), a sleeve pin (1010), a spring-loaded pin casing (1012), a sleeve cavity (1014), a plunger rod arm cavity (1016), a pin protrusion (1018), and a plunger rod arm (1006) configured to extend from the plunger rod separated from or parallel to the sleeve pin slot (1020) (shown when viewing the sleeve (1008) shown in FIG. 20c).

[0132] As in the embodiments illustrated in FIGS. 19a through 19e, the sleeve (1008) may include a flange and may be configured to wrap around the circumference of the syringe body (1004). The assembly (1000) differs from the assembly (900), for example, in that the plunger rod arm (1006) does not include a pin; instead, the plunger rod arm (1006) may include a cavity (1016) into which the sleeve pin (1010) can extend. The sleeve pin (1010) may be slidably connected to the sleeve (1008) so that the sleeve pin extends through the pin slot (1020). In some embodiments, a pin casing (1012) capable of having a spring load can apply force to the sleeve pin (1010) outward from the sleeve (1008), and a pin protrusion (1018) (e.g., illustrated in FIG. 20b) can prevent the sleeve pin (1010) from being pulled out of the pin slot (1020). In the configuration illustrated in FIG. 20a, since the sleeve pin (1010) extends into the plunger rod arm cavity (1016) (e.g., illustrated in FIG. 20b), the sleeve pin (1010) is pressed distally along the length of the pin slot (1020) (e.g., toward the discharge end of the assembly (1000)) causing the plunger rod arm (1006) to move distally (i.e., the plunger rod (1002) also moves distally). This movement of the sleeve pin (1010) and the corresponding movement of the plunger rod (1002) can prime the assembly (1000).

[0133] When the sleeve pin (1010) moves to the distal end of the pin slot (1020), the pin protrusion (1018) can be aligned with the sleeve cavity (1014), which may have a size and configuration to accommodate the pin protrusion (1018). The pin protrusion (1018) can be pulled into the sleeve cavity (1014) by the force applied to the sleeve pin (1010) by the pin casing (1012), thereby separating the sleeve pin (1010) from the plunger rod arm cavity (1016).

[0134] After the sleeve pin (1010) is separated from the plunger rod arm cavity (1016), the plunger rod (1002) can be distally pressed independently of the sleeve pin (1010) (e.g., by the user) to dispense a desired dose of medicine (1005).

[0135] In relation to any embodiment of the present disclosure comprising a sleeve and a pin movable through a channel or slot within the sleeve, it is considered that the channel or slot does not necessarily have to be located within the sleeve. For example, in an embodiment where the sleeve completely or partially surrounds a syringe or syringe body, the sleeve may be replaced, for example, by a channel or slot that is directly imprinted, molded, or otherwise directly arranged on the syringe or syringe body.

[0136] The features listed above have been described in relation to specific embodiments. However, features and aspects of the embodiments may be combined, added to, or removed from the embodiments in any way to assist in the controlled preparation and / or delivery of the drug.

[0137] The embodiments of the above examples have been described in relation to priming the dose and removing excess air bubbles within the syringe. However, the embodiments of the above examples may also be used with refillable syringes and vials of multiple doses. For example, the syringe according to the present disclosure may provide a more precise method for delivering a drug from a vial to a syringe. During the syringe loading step, precision may, for example, reduce or minimize overfilling of the syringe from the vial of the drug. Suppression of overfilling can ultimately reduce drug waste and increase or maximize the number of doses that can be administered from a single vial.

[0138] For example, to fill the syringe (10) shown in FIG. 1, the dial (5) is rotated in the opposite direction to pull the piston (8) out from the distal needle end into the syringe barrel (9) and fill the syringe (10) through the needle (13).

[0139] As an additional example, to fill the syringe (60) illustrated in FIG. 5, the plunger rod (61) rotates in the opposite direction to the direction for priming the needle (66) to pull the piston (68) out from the distal needle end into the syringe barrel (69) and fill the syringe (60) through the needle (66).

[0140] Although numerous embodiments are provided herein, numerous variations to these embodiments and combinations of components from one or more embodiments are possible and are considered to be within the scope of this disclosure. Furthermore, those skilled in the art will understand that the concepts forming the basis of this disclosure can be readily utilized as a basis for designing other devices, methods, and systems to achieve some of the purposes of this disclosure.

Claims

Claim 1 A drug delivery device having a dose release control mechanism, comprising: a barrel including a proximal end and a distal end; a plunger rod extending into the barrel through an opening in the proximal end of the barrel and comprising a depressor and two protrusions, wherein the protrusions protrude radially outward from the central longitudinal axis of the drug delivery device; and a flange covering the proximal end of the barrel and comprising an opening, wherein rotating the plunger rod about the central longitudinal axis switches the drug delivery device from an initial configuration to a dose delivery configuration, wherein in the initial configuration, the flange blocks distal movement of the protrusions to limit the distal movement of the plunger rod to a priming distance, and in the dose delivery configuration, the flange allows distal movement of the protrusions to move the plunger rod to a dose delivery distance. Claim 2 A drug delivery device according to claim 1, wherein the protrusions protrude radially outward from the proximal region of the plunger rod. Claim 3 A drug delivery device according to claim 1, wherein the protrusions have a rectangular shape. Claim 4 A drug delivery device according to claim 1, wherein the opening of the flange has a shape complementary to the cross-section of the protrusions of the plunger rod. Claim 5 A drug delivery device according to claim 1, wherein in the initial configuration of the drug delivery device, the plunger rod and the barrel are in a first non-operating position relative to each other, and the protrusions are offset from the flange in a first direction relative to the flange. Claim 6 In claim 5, in the priming configuration of the drug delivery device, the plunger rod and the barrel are in a second position that are partially actuated relative to each other, and the protrusions are in the first direction relative to the flange, wherein the protrusions are blocked from passing through the opening by the flange. Claim 7 In claim 6, in the dose delivery configuration of the drug delivery device, the plunger rod and the barrel are in a third position fully actuated relative to each other, and the protrusions are in a second direction relative to the flange, wherein the protrusions are aligned with the opening of the flange. Claim 8 A drug delivery device according to claim 7, wherein the flange comprises at least one proximal cavity having a size and structure to accommodate each of the protrusions when in the first direction. Claim 9 A drug delivery device according to claim 8, wherein the flange comprises at least one distal cavity having a size and structure to accommodate each of the protrusions when in the second direction. Claim 10 In claim 6, the drug delivery device, wherein in the priming configuration of the drug delivery device, the protrusions are located at least partially inside the flange. Claim 11 A drug delivery device according to claim 1, wherein the two protrusions comprise a first set of protrusions, and the plunger rod comprises a second set of protrusions located distal to the first set of protrusions. Claim 12 A drug delivery device according to claim 11, wherein the protrusions of the second set have a geometric structure different from the protrusions of the first set. Claim 13 A drug delivery device according to claim 11, wherein the protrusions of the second set are configured to restrict the movement of the plunger rod after the protrusions are received in the flange of the first set. Claim 14 A drug delivery device according to claim 11, wherein the protrusions of the second set are configured to control the dose volume distributed from the barrel. Claim 15 A drug delivery device according to claim 1, wherein the plunger rod is configured to generate feedback in response to the plunger rod rotating relative to the flange from the initial configuration to the dose delivery configuration. Claim 16 A drug delivery device according to claim 15, wherein the feedback comprises auditory feedback or tactile feedback. Claim 17 A drug delivery device having a dose release control mechanism, comprising: a barrel including a proximal end and a distal end; a plunger rod extending into the interior of the barrel along a central longitudinal axis of the drug delivery device, wherein the plunger rod comprises two protrusions symmetrically arranged about the central longitudinal axis and the plunger rod is rotatable about the central longitudinal axis; and a flange including a geometric structure configured to receive the protrusions when the protrusions are aligned with the geometric structure, wherein in an initial configuration of the drug delivery device, the protrusions are longitudinally spaced from the flange and are not aligned with the geometric structure, in a priming configuration of the drug delivery device, the protrusions are in contact with the proximal side of the flange and are not aligned with the geometric structure, in a dose delivery configuration of the drug delivery device, the protrusions are aligned with the geometric structure and arranged proximally from the geometric structure, and in a delivery configuration of the drug delivery device, the protrusions are aligned with the geometric structure and are received within the geometric structure. Claim 18 A drug delivery device according to claim 17, wherein the two protrusions comprise a pair of first protrusions, and the plunger rod comprises a pair of second protrusions offset in a rotational direction from the pair of first protrusions. Claim 19 A drug delivery device according to claim 18, wherein the pair of second protrusions are configured to contact the flange when the pair of first protrusions are received through the geometric structure of the flange. Claim 20 A drug delivery device according to claim 19, wherein the pair of second protrusions are configured to extend through the geometry of the flange in response to the plunger rod rotating relative to the flange. Claim 21 A drug delivery device according to claim 18, wherein the plunger rod comprises a stopper positioned in proximity to the protrusions, and the stopper has a size and shape not configured to extend through the geometry of the flange in any direction relative to the flange of the plunger rod. Claim 22 A drug delivery device having a dose release control mechanism, comprising: a barrel including a proximal end and a distal end; a plunger rod extending along the central longitudinal axis of the drug delivery device into the interior of the barrel through an opening at the proximal end of the barrel; a depressor attached to the plunger rod at a first end; and a plunger attached to the plunger rod at a second end opposite to the first end, wherein the plunger and the plunger rod are formed together in an integral structure in which the plunger and the plunger rod are formed in a single mold. A drug delivery device comprising a stop portion extending through the plunger rod and the plunger, wherein the stop portion is movable between a first configuration and a second configuration, wherein in the first configuration, the stop portion is configured to prevent distal movement of the depressor and the plunger rod after the plunger rod has traveled a priming distance, and after transitioning from the first configuration to the second configuration, the stop portion is configured to allow the depressor and the plunger rod to move further distal relative to the barrel. Claim 23 A drug delivery device having a dose release control mechanism, comprising: a barrel including a proximal end and a distal end; a plunger rod extending along the central longitudinal axis of the drug delivery device into the interior of the barrel through an opening in the proximal end of the barrel, wherein the plunger rod comprises a depressor, a stopper, and a plunger, and wherein the stopper is located between the depressor and the plunger and at the end of the plunger rod opposite the plunger; a stop portion movable between a first configuration and a second configuration, wherein the stop portion is configured to prevent distal movement of the plunger rod after the plunger rod has traveled a priming distance while the stop portion is in the first configuration, and wherein the stop portion is configured to allow the plunger rod to move further distal through the barrel after switching from the first configuration to the second configuration; A drug delivery device comprising a flange located at or adjacent to the proximal end of the barrel, wherein the flange includes a hole for receiving a body and the plunger rod, and the stopper cannot extend through the hole in any configuration, so that the stopper abuts the body when the plunger rod is received through the flange. Claim 24 A drug delivery device comprising: a barrel comprising a longitudinal axis, a proximal end region, a distal end region, and an interior, wherein the proximal end region comprises an opening and the interior comprises a threaded region; and a plunger rod at least partially arranged within the barrel and protruding from the opening, wherein the plunger rod comprises a threaded region configured to engage with the threaded region within the barrel, and wherein rotation of the plunger rod around the longitudinal axis of the drug delivery device moves the plunger rod along the longitudinal axis. Claim 25 A drug delivery device according to claim 24, wherein the plunger rod comprises at least one stop portion located along the outer surface of the plunger rod and proximal to the threaded portion of the plunger rod. Claim 26 A drug delivery device according to claim 25, wherein the barrel comprises a slot having a size and shape to accommodate the stop portion of the plunger rod. Claim 27 In paragraph 26, the drug delivery device, wherein the slot extends along the interior of the barrel and through the threaded area of ​​the barrel. Claim 28 A drug delivery device according to claim 27, wherein the slot comprises a first vertical portion extending through a first portion of the threaded region of the barrel, a second horizontal portion extending through a second portion of the threaded region of the barrel, and a third vertical portion extending through a third portion of the threaded region of the barrel. Claim 29 A drug delivery device according to claim 28, wherein the stop portion is configured to enter the slot in the first vertical portion, and the plunger rod is configured to translate relative to the barrel as the stop portion slides through the first vertical portion. Claim 30 A drug delivery device according to claim 29, wherein when the stop portion slides completely through the first vertical portion, the stop portion is configured to slide through the second horizontal portion in response to the rotation of the plunger rod around the longitudinal axis of the drug delivery device. Claim 31 A drug delivery device according to claim 30, wherein the plunger rod is configured to rotate in the opposite direction to the threaded portion of the plunger rod, thereby causing the stop portion to slide through the second horizontal portion of the slot. Claim 32 A drug delivery device according to claim 30, wherein the plunger rod is restrained from advancing distally relative to the barrel until the stop portion slides through the second horizontal portion of the slot. Claim 33 A drug delivery device according to claim 30, wherein when the stopper slides completely through the second horizontal portion, the stopper slides through the third vertical portion to release a dose volume from the barrel. Claim 34 A drug delivery device according to claim 25, wherein the plunger rod comprises a pair of stop portions, and the pair of stop portions comprises protrusions that protrude radially outward from the plunger rod. Claim 35 A drug delivery device according to claim 24, wherein the barrel includes a finger flange in the proximal end region and the threaded region is located along the inner surface of the finger flange.

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