Precision dose delivery device plunger rod insertion gauge and method therefor - Patents.com

Abstract

A plunger rod insertion gauge for a precision dose delivery device is disclosed. The insertion gauge includes an insertion gauge body including a handle portion and a gauge portion, the gauge portion including one or more plunger rod abutment surfaces and one or more flange abutment surfaces oriented substantially perpendicular to a plunger rod insertion axis, and a dimension measured between the one or more plunger rod abutment surfaces and the one or more flange abutment surfaces determines a maximum plunger rod insertion depth for a precision dose delivery device. Other aspects are described and claimed.

Description

[Technical Field]

[0001] Aspects of the present disclosure relate to devices and methods for assembling, priming, or otherwise configuring dose delivery devices, such as syringes, to facilitate precision dose delivery. More particularly, embodiments of the present disclosure relate to devices for assisting in the insertion of plungers of precision dose delivery devices. [Background technology]

[0002] Introduction Formulations containing fluid drug substances can be delivered to patients in a variety of ways, including via injection. In many cases, the precision and accuracy of the volume of a liquid formulation is important. For example, healthcare professionals may be interested in ensuring that the approved or prescribed volume of drug substance is consistently delivered to each patient in need of the drug. Additionally, even slight over- or under-administration of a drug substance to a patient can have undesirable (or even negative) clinical effects on the patient. Furthermore, some formulations are formulated in low volumes (e.g., less than about 100 μL). At low volumes, human error in preparing and delivering the exact dose of drug substance for injection can affect the efficacy of the drug in the patient and subsequent clinical effects in the patient.

[0003] During assembly of the device to provide these precise doses of drug substance, the plunger must often be inserted into the device body to an appropriate depth, beyond which movement of the stopper may occur, which may compromise the integrity of the seal of the drug delivery device.

[0004] The entire disclosure of commonly owned U.S. Patent No. 6,273,999, which discloses a dose delivery device, is incorporated herein by reference, except for any definitions, disclaimers, or disclaimers, and except to the extent the incorporated material is inconsistent with the express disclosure of this specification, in which case the language in this disclosure will control. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 11,439,758 Summary of the Invention

[0006] According to certain aspects of the present disclosure, an insertion gauge device is disclosed that engages with components of a precision dose delivery device during assembly of the device. In one aspect, a plunger rod insertion gauge for a precision dose delivery device is provided, the insertion gauge comprising an insertion gauge body including a handle portion and a gauge portion, the gauge portion including one or more plunger rod abutment surfaces and one or more flange abutment surfaces oriented substantially perpendicular to a plunger rod insertion axis, wherein a dimension measured between the one or more plunger rod abutment surfaces and the one or more flange abutment surfaces determines a maximum plunger rod insertion depth for the precision dose delivery device.

[0007] In another aspect, a plunger rod insertion gauge for a precision dose delivery device is disclosed, the insertion gauge including a gauge spacer including a first gauge spacer surface and a second gauge spacer surface, a receiver block positioned adjacent to the gauge spacer and including a first receiver block surface and a second receiver block surface, and a protruding element positioned above the receiver block, wherein a dimension between the first gauge spacer surface and the second gauge spacer surface determines a maximum plunger rod insertion depth for the precision dose delivery device.

[0008] In yet another aspect, a method of assembling a dose delivery device is disclosed that includes axially inserting a lower end of a plunger rod into a device body through an opening in a flange portion of the dose delivery device, positioning an insertion gauge laterally adjacent to an upper end of the plunger rod, and applying an axial force to the insertion gauge to move the plunger rod axially into the opening in the flange portion until the insertion gauge abuts the flange portion and the plunger rod.

[0009] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosed embodiments, as claimed. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of a device for assisting in the insertion of a plunger of a precision dose delivery device, for example, during assembly, and together with the description, serve to explain the principles of the disclosed embodiments. The drawings depict several aspects of the present disclosure. [Brief explanation of the drawings]

[0010] [Figure 1] 1 illustrates an exemplary insertion gauge device and precision dose delivery device, according to some embodiments of the present disclosure. [Figure 2] 1 shows a perspective view of an insertion gauge device according to some embodiments of the present disclosure. [Figure 3] 1 illustrates an exemplary insertion gauge device engaged with a precision dose delivery device, according to some embodiments of the present disclosure. [Figure 4] 1 illustrates an exemplary insertion gauge device having a handle portion, according to some embodiments of the present disclosure. [Figure 5] 5 shows a front view of the insertion gauge device of FIG. 4 according to some embodiments of the present disclosure. [Figure 6] 5 shows a side view of the insertion gauge device of FIG. 4 according to some embodiments of the present disclosure. [Figure 7] 5 shows a top view of the insertion gauge device of FIG. 4 according to some embodiments of the present disclosure. [Figure 8] 1 shows an exemplary flowchart of a method for assembling a plunger rod into a body of a drug delivery device containing a predetermined amount of liquid (e.g., a formulated drug substance) using an insertion gauge, according to one or more embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0011] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements not only includes those elements, but may also include other elements not expressly listed and not inherent to such process, method, article, or apparatus. The term “exemplary” is used in the sense of “example” rather than “ideal.” In particular, an embodiment or implementation described herein as “example” or “exemplary” should not be construed as preferred or advantageous over other embodiments or implementations, for example, but rather reflects or indicates that the embodiment(s) is / are an “example” rather than “ideal.” Additionally, the use of terms such as “first,” “second,” etc. herein does not denote any order, quantity, or importance, but rather is used to distinguish one element, structure, step, or process from another. Furthermore, the terms "a" and "an" as used herein do not denote a limitation of quantity, but rather denote the presence of one or more of the referenced item. Furthermore, the terms "about," "approximately," "substantially," and the like, when used in describing a numerical value, indicate a + / - 10% variance of that value, unless otherwise specified.

[0012] Embodiments of the present disclosure may be used with any type of fluid-containing product, such as a liquid drug substance, a liquid placebo, or other liquid that can be dispensed in a dosage form. As used herein, the term "drug substance" may refer to a formulated substance containing an active ingredient(s), such as a small or large molecule, such as an analgesic, steroid, or biologic. As used herein, the term "biologic" may refer to a large molecule (e.g., greater than 15 kDa, greater than 30 kDa, greater than 50 kDa, greater than 75 kDa, or greater than 100 kDa) produced within a biological system, such as a cell. Biologics may include proteins (e.g., antibodies), nucleic acids, large sugars, etc. Unlike small molecules, which may have well-defined chemical structures, biologics may have highly complex structures that cannot be easily quantified by laboratory methods. As used herein, the term "formulation" may refer to a volume of drug substance apportioned into a primary packaging component for packaging, transportation, delivery, and / or administration to a patient.

[0013] The term "primary packaging component" refers to a packaging component for a drug product, such as a drug container, that is designed and manufactured to be in direct physical contact with the formulated drug substance. (See, e.g., Guidance for Industry on Container Closure Systems for Packaging Human Drugs and Biologics, USDapartment of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research (May 1999), which is incorporated herein by reference.) Examples of primary packaging components include prefillable syringes, Luer syringes, cartridges, and vials made of glass, plastic, other polymers or copolymers, and / or other materials.

[0014] As used herein, the terms "distal" and "distally" refer to a location (or portion of a device) relatively near or toward the patient delivery site, and the terms "proximal" and "proximally" refer to a location (or portion of a device) relatively near or toward the user end opposite the distal location / portion of the device.

[0015] As used herein, the term "body," when used with reference to a portion of a device, can refer to a component of a device suitable for containing a volume of active pharmaceutical ingredient. The body may include, for example, a barrel (such as a syringe barrel), a tube, a cylinder, or other containing portion of a device. For example, in some embodiments, the body may be a syringe barrel made of glass and / or a barrel that is free of silicone oil, substantially free of silicone oil, and / or capable of containing less than 50 μg of silicone oil. In some embodiments, the body may also include a distal end portion having a nozzle, a needle, a needle attachment site, and / or a distal cap.

[0016] Embodiments of the present disclosure may typically be used with products having small dosage volumes, such as ophthalmic formulations. In some embodiments, devices of the present disclosure may be used with formulations including, for example, ophthalmic solutions having 5 or fewer particles with a diameter of ≥ 25 μm per ml and / or 50 or fewer particles with a diameter of ≥ 10 μm per ml. In some embodiments, devices of the present disclosure may be used with formulations including large molecules, e.g., molecular weights of 30 kDA or greater. In some embodiments, devices of the present disclosure may be used with formulations including fragments of large molecules. For example, in some embodiments, devices of the present disclosure may be used with formulations including antigen-binding molecules. In some aspects, the antigen-binding molecules may be antibodies or antigen-binding fragments. In some embodiments, devices of the present disclosure may be suitable for use with vascular endothelial growth factor (VEGF) inhibitors and / or large and small molecule antagonists of VEGF and / or angiopoietin-2. In some embodiments, devices of the present disclosure may be suitable for use with formulations comprising components such as, for example, aflibercept, alirocumab, abicipar pegol, bevacizumab, brolucizumab, conbercept, dupilumab, evolocumab, tocilizumab, certolizumab, abatacept, rituximab, infliximab, ranibizumab, sarilumab, adalimumab, anakinra, trastuzumab, pegfilgrastim, interferon beta-1a, insulin glargine [rDNA origin], epoetin alfa, darbepoetin, filgrastim, golimumab, etanercept, an antigen-binding fragment of any of the above, or combinations of such binding domains, such as bispecific antibodies against VEGF or angiopoietin-2, among others. Drugs suitable for use with dose delivery devices according to the present disclosure may be used to treat ocular diseases such as, for example, choroidal neovascularization, wet age-related macular degeneration, macular edema secondary to retinal vein occlusion (RVO) (including branch RVO and central RVO), choroidal neovascularization secondary to pathologic myopia (PM), diabetic macular edema (DME), diabetic retinopathy, or proliferative retinopathy.

[0017] In some embodiments, the devices and aspects of the present disclosure can help provide accurate dose delivery while also maintaining container closure integrity (CCI). Furthermore, pre-loading the drug into the devices of the present disclosure can minimize the steps required to prepare the dose for delivery to the patient. During this loading process, proper insertion of the plunger rod into the drug delivery device body can prevent undesired stopper movement and support accurate and sterile drug administration.

[0018] In some embodiments, a device according to the present disclosure may be used in the preparation of a precision drug delivery device. For example, in some embodiments, a device according to the present disclosure may engage a portion of a precision drug delivery device to mechanically prevent over-insertion of a plunger rod into the drug delivery device body.

[0019] Currently, the dose delivery device market, particularly the prefilled syringe market, needs a mechanism that allows users to accurately set a small volume of product in a syringe (e.g., a prefilled syringe or a fillable / refillable syringe) for delivery while maintaining the integrity of the closed container.Embodiments of the present disclosure can assist manufacturers, formulation suppliers, medical professionals, and / or patients in accurately making, filling, or otherwise preparing dose administration devices.Furthermore, embodiments of the present disclosure can help prevent or mitigate errors or variations in device manufacturing or use, such as errors in plunger rod insertion and stopper positioning.

[0020] The embodiments or aspects of the embodiments disclosed herein may be used in conjunction with existing syringe body parts to modify off-the-shelf products, which may shorten development and manufacturing time for dose delivery devices. In other cases, the embodiments or aspects of the embodiments disclosed herein may be provided to users along with precision drug delivery devices during their manufacture. Syringes in which the plunger rod insertion gauges described herein may be used may be pre-filled or fillable / refillable.

[0021] In some embodiments, precision drug delivery devices according to the present disclosure may be shown as including one type of plunger rod and plunger, or as including a general schematic representation of a plunger rod and plunger. For example, some devices according to the present disclosure may be depicted or described as including a plunger rod having a ball-shaped tip that engages with a stopper, such that the plunger rod and stopper may be attached together. In some embodiments, the plunger rod and stopper may not be physically fixed to one another. In this manner, pushing the plunger rod distally may urge the stopper distally, but retracting the plunger rod proximally does not retract the stopper. It is contemplated that plunger rod insertion gauges may be designed, adapted, and / or configured for use with multiple and / or different configurations of plunger rods and stoppers, as may be appropriate.

[0022] Referring now to FIG. 1 , a plunger rod insertion gauge 100 according to an embodiment of the present disclosure is shown adjacent to an exemplary precision drug delivery device 200. The drug delivery device 200 can include a body 205 and a blocking component in the form of a flange piece 210 having a proximal collar 215 surrounding an opening through which the plunger rod 220 can pass. The plunger rod 220 can include an actuation portion 225 in the form of a plunger head that can be actuated (e.g., pushed or twisted) to rotate the plunger rod 220 or to move the plunger rod 220 longitudinally into the body 205. The actuation portion 225 can include a first portion 230 and a second portion 235. The first portion 230 can be torus-shaped, while the second portion 235 can be cylindrical. The first portion 230 can be positioned longitudinally adjacent to the second portion 235, and the diameter of the first portion 230 can be larger than the diameter of the second portion 235.

[0023] The flange member 210 functions as a blocking component within the drug delivery device 200 and may be of any suitable size and / or shape to close, partially close, cover, or partially cover the end of the body 205 opposite the end where the drug is released and covered by the closure 260 (e.g., a tamper-evident closure). In some embodiments, the flange member 210 may include a proximal collar 215 configured to engage with the body 205 and hold the flange member 210 in place relative to the body 205. The proximal collar 215 of the flange member 210 may be sized and configured to receive a portion of the actuating portion 225 of the plunger rod 220 while preventing the protrusion 240 of the plunger rod 220 from moving distally beyond a predetermined point until the plunger rod 220 is rotated to a specific position. As shown in FIGS. 1-2 , the proximal collar 215 may be cylindrical; in alternative embodiments, the proximal collar 215 may have any suitable size or shape that is compatible with the actuating portion 225. In some embodiments, the flange component 210 may include one or more flanges 245, which may be sized and configured to assist a user in holding the drug delivery device 200 and / or releasing the formulated active pharmaceutical ingredient from the drug delivery device 200.

[0024] The plunger rod 220 may be rotatable (e.g., in one or both directions) about the central longitudinal axis, for example, by gripping and / or twisting the actuating portion 225 of the plunger rod 220 relative to the flange member 210 and / or the body 205. In some embodiments, the protrusion 240 can assist the user in gripping and / or twisting the actuating portion 225 relative to the flange member 210 and / or the body 205 by providing additional surface area that the user can grip and / or press against to twist the actuating portion 225. The plunger rod 220 can include a distal tip 250 sized and configured to press against, attach to, or otherwise connect with a stopper 255. The stopper 255 can form part of the seal between the drug substance 265 and the environment, an aspect of the CCI necessary to maintain drug safety and efficacy. Proper stopper positioning and appropriate restraints on movement that could compromise the CCI can be beneficial to ensure consistent filling and proper sealing.

[0025] According to the present disclosure, a plunger rod insertion gauge (“insertion gauge”) 100 may be associated with the precision drug delivery device 200 during insertion of the plunger rod 220 to aid in proper rod insertion, which in turn can aid in maintaining proper stopper positioning and CCI. The plunger rod insertion gauge 100 may be shaped to cooperate with one or more surfaces of the flange component 210, the proximal collar 215, and / or the actuation portion 225 of the plunger rod 220, so that when engaged (as shown in FIG. 3 ), it prevents the plunger rod 220 from being inserted into the precision drug delivery device body 200 more than a desired amount, thereby determining the maximum plunger rod insertion depth of the plunger rod 220.

[0026] 2 illustrates an exemplary plunger rod insertion gauge 100 according to the present disclosure. The insertion gauge 100 may include gauge spacers 105 positioned substantially opposite one another. Each of the gauge spacers 105 of the insertion gauge 100 may include a first surface 110 and a second surface 115. The second surface 115 may be located opposite the first surface 110, and both the first surface 110 and the second surface 115 may be substantially flat.

[0027] The insertion gauge 100 may also include a receiving block 120 positioned adjacent to the gauge spacer 105. The receiving block 120 may include a receiving wall 125, first and second vertical surfaces 130, 135, and first and second horizontal surfaces 140, 145. The receiving wall 125 may have an arcuate shape complementary to the second portion 235 of the actuation portion 225 of the drug delivery device 200. The height of each of the first and second vertical surfaces 130, 135 may be determined by a distance 150 between the first and second horizontal surfaces 140, 145. In some embodiments, the second horizontal surface 145 may be the same as or otherwise extend in the same plane as the second surface 115 of the gauge spacer 105. In some embodiments, the first and second vertical surfaces 130, 135 may be flush with the outer surface of the gauge spacer 105.

[0028] The insertion gauge 100 may also include a protruding element 155 that may extend away from the second receiving wall 160 between the protruding portions of the gauge spacer 105 and into the space above the first horizontal surface 140 and the receiving wall 125. The second receiving wall 160 may be positioned between the first horizontal surface 140 of the receiving block 120 and a first protruding surface 165 of the protruding element 155.

[0029] The combination of the gauge spacers 105 forms a receiving area for the actuation portion 225 of the plunger rod 220. More specifically, the space 170 between the gauge spacers 105 can be larger than the diameter of the second portion 235 of the actuation portion 225 of the plunger rod 220, such that when the insertion gauge 100 interacts with the drug delivery device 200, the second portion 235 of the actuation portion 225 can fit between the gauge spacers 105 and be aligned / contacted with the receiving wall 125 of the receiving block 120 of the insertion gauge 100. As further shown and described herein, when aligned, the first surface 110 of each gauge spacer 105 can interact with the bottom surface 270 of the protrusion 240, and the second surface 115 of each gauge spacer 105 can interact with the top surface 275 of the proximal collar 215. Additionally, when aligned, the first portion 230 of the actuating portion 225 can fit within the space between the first horizontal surface 140 and the first protruding surface 165 of the protruding element 155. In some embodiments, the first portion 230 of the actuating portion 225 may contact the second receiving wall 160.

[0030] The height 175 of the gauge spacer 105 may serve as a critical dimension of the plunger rod insertion gauge 100 that dictates the depth to which the plunger rod 220 can be inserted into the body 205 of the drug delivery device 200. Thus, the height of the gauge spacer 105 may be inversely related to the insertion depth of the plunger 220. More specifically, a higher height of the gauge spacer 105 may correspond to a shallower insertion depth of the plunger rod 220, and vice versa.

[0031] The height 175 of the gauge spacer 105 may vary between insertion gauges depending on the maximum plunger rod insertion depth required. For example, insertion gauge A having a first height may be employed in situations dictating that a first volume of drug solution needs to be placed, while insertion gauge B having a second, higher height may be employed in situations dictating that a second, lower volume of drug solution needs to be placed. The particular profiling of the insertion gauge 100 (i.e., the various outer shapes and / or dimensions of the insertion gauge 100) may be generic for multiple drug delivery devices or may be customizable to more closely match a particular plunger rod design. For example, the surface structure of the actuating component of the plunger rod for drug delivery device A may differ from the surface structure of the actuating component of the plunger rod for drug delivery device B. In such situations, two separate plunger rod insertion gauges may be employed, with the profile of each of these insertion gauges shaped to match the surface structure of their respective drug delivery devices. To support the reuse of the insertion gauge, the insertion gauge may be made from a material such as plastic and / or rubber that is compatible with the assembly situation (i.e., can be sterilized and is resistant to any solvents used) and will not scratch the drug delivery device elements to avoid marking or damaging the drug delivery device.

[0032] 3 shows a plunger rod insertion gauge 100 that interacts with actuation portion 225 of plunger rod 220 to determine the position of plunger rod 220. When plunger rod 220 is inserted to a desired depth (determined by the insertion gauge 100 used), one or more surfaces of plunger rod insertion gauge 100 interfere with one or more surfaces of flange component 210 (e.g., top surface 275 of proximal collar 215, etc.) and / or one or more surfaces of actuation portion 225 (e.g., bottom surface 270 of protrusion 240 of actuation portion 225, etc.). At this point, plunger rod 220 and / or stopper 255 are prevented from further longitudinal movement into device body 205, thereby determining the final expelled volume of formulated drug substance 265, and plunger rod insertion gauge 100 can be disengaged. In some embodiments, the insertion gauge 100 is not rigidly secured to the actuation portion 225 of the plunger rod 220 (e.g., is not frictionally attached to the plunger rod 220 (e.g., by a snap fit)), but rather is free to move independently of the plunger rod 220 along the second portion 235 of the plunger rod 220, at least in a direction perpendicular to the longitudinal axis of the plunger rod 220. In other embodiments, the insertion gauge 100 may be selectively attached to the plunger rod 220. As a result, the plunger rod insertion gauge 100 may be reusable for subsequent filling of the same or different drug delivery devices.

[0033] FIG. 4 illustrates an exemplary handled plunger rod insertion gauge 300 that includes an extension portion configured for use as a handle. The handle portion 305 may extend from a surface of the insertion gauge portion 310 opposite the side configured to abut the plunger rod precision drug delivery device 200. The handle portion 305 may be shaped to allow a user to securely grip the gauge 300, which may aid in positioning the insertion gauge portion 310 relative to the plunger rod, applying axial forces to the insertion gauge portion 310, and separating the insertion gauge portion 310 from the plunger rod actuation portion 225. In some embodiments, the size and shape of the handle portion 305 may be modified to better fit a user's hand. As shown in FIG. 4, a downward protrusion 315 may be included at the end of the handle portion 305 to prevent the insertion gauge portion 310 from slipping out of the user's hand. Other structures that may be included to better fit the user's hand may include, for example, adding finger recesses, a surface finish for improved grip, and / or one or more through holes through which fingers or a strap may pass.

[0034] Referring now collectively to FIGS. 5-7, various different views of the handled insertion gauge 300 shown in FIG. 4 are provided in accordance with the present disclosure. FIG. 5 shows a front view of the handled insertion gauge 300. From this perspective, the height 320 of the handled insertion gauge 300 can be appreciated. While the height 320 can be virtually any height, in some embodiments, the height may be about 30 mm to about 40 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, or about 40 mm. In one embodiment, the height may be 35.93 mm. FIG. 6 shows a side view of the handled insertion gauge 300. From this perspective, the length 325 of the handled insertion gauge 300 can be appreciated. While the length 325 can be virtually any length, in some embodiments, the length may be about 80 mm to about 120 mm, or about 90 mm to about 100 mm. In one embodiment, the length may be 100 mm. FIG. 7 shows a top view of the handled insertion gauge 300. From this perspective, the maximum width 330 of the insertion gauge portion 310 of the handled insertion gauge 300 can be seen. The maximum width 330 can be virtually any width, but in some embodiments, the width may be about 30 mm to about 40 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, or about 40 mm. In one embodiment, the maximum width may be 35 mm.

[0035] FIG. 8 shows a flowchart illustrating an exemplary method 800 of assembling a plunger rod into a body of a drug delivery device containing a predetermined amount of liquid (e.g., a formulated drug substance) using an insertion gauge, according to one or more embodiments of the present disclosure.

[0036] In step 805, the plunger rod 220 of the drug delivery device 200 may be inserted into the device body 205 containing a liquid (e.g., a formulated drug substance 265). An insertion gauge 100 or 300 may optionally be positioned laterally adjacent to the actuation portion 225 of the plunger rod 220 during this step.

[0037] In step 810, the insertion gauge 100 or 300 may be positioned laterally adjacent to the actuation portion 225 of the plunger rod 220. In this regard, the second portion 235 of the actuation portion 225 may fit through the space 170 defined by the gauge spacer 105 and contact the receiving wall 125 of the insertion gauge 100 or 300. At the same time, the first portion 230 of the actuation portion 225 may fit between the space provided by the first horizontal surface 140 of the receiving block 120 and the first protruding surface 165 of the protruding element 155. In this contact state, the first surface 110 of each gauge spacer 105 may contact the bottom surface 270 of the protrusion 240 of the actuation portion 225.

[0038] In step 815, an axial force may be applied to the insertion gauge 100 to move the plunger rod 220 downward to a second position where the second surface 115 of the gauge spacer 105 abuts the upper surface 275 of the proximal collar 215 of the flange part 210 of the drug delivery device 200. The application of this force may cause the first protruding surface 165 of the protruding element 155 to contact the upper surface of the first part 230 of the actuation portion 225, thereby moving the plunger rod 220 downward into the body 205 of the drug delivery device 200. Liquid within the drug delivery device 200 in step 805 may be expelled from the drug delivery device 200 until contact between the second surface 115 of the gauge spacer 105 and the upper surface 275 of the proximal collar 215 is achieved. The liquid remaining in the drug delivery device 200 after the application of the force may determine the dose volume.

[0039] In step 820, the insertion gauge 100 or 300 may be separated from the actuation portion 225 of the plunger rod 220. More specifically, the insertion gauge 100 may be moved laterally in a direction substantially perpendicular to the direction of the force applied in step 815.

[0040] Components of the devices described herein can be designed and / or adapted for manufacturing in one or more ways. In some embodiments, for example, a plunger rod insertion gauge can be adapted for manufacturing by, for example, injection molding, 3D printing, or machining. Precision can be particularly important, for example, to ensure proper fit and range of motion of the plunger rod during insertion.

[0041] Implementations of the present disclosure may include the following features. Item 1. A plunger rod insertion gauge for a precision dose delivery device, the insertion gauge including an insertion gauge body including a handle portion and a gauge portion; the gauge portion including one or more plunger rod abutment surfaces and one or more flange abutment surfaces oriented substantially perpendicular to a plunger rod insertion axis; a dimension measured between the one or more plunger rod abutment surfaces and the one or more flange abutment surfaces determines a maximum plunger rod insertion depth for the precision dose delivery device; Insertion gauge.

[0042] Item 2. The insertion gauge described in Item 1, wherein the one or more plunger rod abutment surfaces include at least one surface configured to abut a portion of the plunger rod located between the upper surface of the plunger rod and the upper surface of the flange portion of the precision dose delivery device.

[0043] Item 3. The insertion gauge of item 2, wherein the one or more plunger rod abutment surfaces include at least one surface configured to abut the top surface of the plunger rod. Item 4. The insertion gauge of item 2, wherein the portion of the plunger rod is a protruding element, and the one or more plunger rod abutment surfaces include at least one surface configured to abut a bottom surface of the protruding element.

[0044] Item 5. The insertion gauge of item 2, wherein the one or more plunger rod abutment surfaces include a first receiving surface and a second receiving surface, the portion of the plunger rod includes a first actuating portion and a second actuating portion, the first actuating portion being torus-shaped and the second actuating portion being cylindrical.

[0045] Item 6. The insertion gauge of item 5, wherein the first receiving surface is configured to abut the second actuation portion of the plunger rod, the second receiving surface is configured to abut the first actuation portion of the plunger rod, and the first receiving surface is positioned below the second receiving surface.

[0046] Item 7. The insertion gauge of item 2, wherein the upper surface of the flange portion is an upper surface of a proximal collar of the flange portion. Item 8. The insertion gauge of item 1, wherein the handle portion includes one or more structures to assist a user in gripping the insertion gauge.

[0047] Item 9. A plunger rod insertion gauge for a precision dose delivery device, comprising: The insertion gauge is a gauge spacer including a first gauge spacer surface and a second gauge spacer surface; a receiving block positioned adjacent to the gauge spacer, the receiving block including a first receiving block surface and a second receiving block surface; and a protruding element positioned above the receiving block; a dimension between the first gauge spacer surface and the second gauge spacer surface determines a maximum plunger rod insertion depth for the precision dose delivery device; Insertion gauge.

[0048] Item 10. The insertion gauge of item 9, wherein the receiving block further includes a first receiving surface, the first receiving surface being arcuate. Item 11. The insertion gauge of item 10, wherein the first receiving surface is configured to abut a first portion of an actuation portion of a plunger rod of the precision dose delivery device.

[0049] Item 12. The insertion gauge of item 9, further comprising a receiving area defined between the first receiving block surface of the receiving block and the first surface of the protruding element. Item 13. The insertion gauge of item 12, wherein a second portion of the actuation portion of the plunger rod of the precision dose delivery device is configured to reside within the receiving area.

[0050] Item 14. The insertion gauge described in Item 9, wherein the first gauge spacer surface is configured to abut a portion of a plunger rod of the precision dose delivery device, and the second gauge spacer surface is configured to abut a portion of a flange component of the precision dose delivery device.

[0051] Item 15. A method for assembling a dose delivery device, comprising: inserting a lower end of a plunger rod axially into a device body through an opening in a flange portion of said dose delivery device; positioning an insertion gauge laterally adjacent to an upper end of the plunger rod; and applying an axial force to the insertion gauge to move the plunger rod axially into the opening in the flange portion until the insertion gauge abuts the flange portion and the plunger rod; A method comprising:

[0052] Item 16. The method of item 15, wherein the insertion gauge includes an insertion gauge body including a handle portion and a gauge portion. Item 17. The method of item 16, wherein the handle portion includes one or more structures to assist a user in gripping the insertion gauge during the positioning.

[0053] Item 18. The method of item 16, wherein the positioning includes positioning one or more plunger rod abutment surfaces of the gauge portion against one or more surfaces of the upper end of the plunger rod.

[0054] Item 19. The method of item 15, wherein the maximum insertion depth of the plunger rod is determined when the insertion gauge abuts the flange portion and the plunger rod. Item 20. The method of item 15, further comprising, after the insertion gauge abuts the flange portion and the plunger rod, separating the insertion gauge from the upper end of the plunger rod by moving the insertion gauge laterally in a direction substantially perpendicular to the direction of the axial force.

[0055] The many features and advantages of the present disclosure will be apparent from the detailed specification, and it is, therefore, intended by the appended claims to cover all such features and advantages of the present disclosure that fall within the true spirit and scope of the present disclosure. Further, because numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the disclosure to the exact construction and operation illustrated and described, and therefore, all suitable modifications and equivalents may be resorted to, within the scope of the present disclosure.

[0056] The devices of the present disclosure are operable to assist in providing consistent and accurate plunger rod insertion for drug delivery devices. Those skilled in the art will appreciate that the concepts on which the present disclosure is based may readily be used as a basis for designing other devices, methods, and systems for carrying out the objectives of the present disclosure. Accordingly, the scope of the claims should not be deemed limited by the foregoing description.

Claims

1. 1. A plunger rod insertion gauge for a precision dose delivery device, the insertion gauge comprising: an insertion gauge body including a handle portion and a gauge portion; the gauge portion including one or more plunger rod abutment surfaces and one or more flange abutment surfaces oriented substantially perpendicular to a plunger rod insertion axis; a dimension measured between said one or more plunger rod abutment surfaces and said one or more flange abutment surfaces determines a maximum plunger rod insertion depth for the precision dose delivery device; Insertion gauge.

2. 2. The insertion gauge of claim 1, wherein the one or more plunger rod abutment surfaces include at least one surface configured to abut a portion of the plunger rod located between an upper surface of the plunger rod and an upper surface of a flange portion of the precision dose delivery device.

3. The insertion gauge of claim 2 , wherein the one or more plunger rod abutment surfaces include at least one surface configured to abut the top surface of the plunger rod.

4. The insertion gauge of claim 2 , wherein the portion of the plunger rod is a protruding element, and the one or more plunger rod abutment surfaces include at least one surface configured to abut a bottom surface of the protruding element.

5. 3. The insertion gauge of claim 2, wherein the one or more plunger rod abutment surfaces include a first receiving surface and a second receiving surface, the portion of the plunger rod includes a first working portion and a second working portion, the first working portion being torus-shaped and the second working portion being cylindrical.

6. 6. The insertion gauge of claim 5, wherein the first receiving surface is configured to abut the second actuating portion of the plunger rod, the second receiving surface is configured to abut the first actuating portion of the plunger rod, and the first receiving surface is positioned below the second receiving surface.

7. The insertion gauge of claim 2 , wherein the upper surface of the flange portion is an upper surface of a proximal collar of the flange portion.

8. The insertion gauge of claim 1 , wherein the handle portion includes one or more structures to assist a user in gripping the insertion gauge.

9. 1. A plunger rod insertion gauge for a precision dose delivery device, comprising: The insertion gauge is a gauge spacer including a first gauge spacer surface and a second gauge spacer surface; a receiving block positioned adjacent to the gauge spacer and including a first receiving block surface and a second receiving block surface; and a protruding element positioned above the receiving block; a dimension between the first gauge spacer surface and the second gauge spacer surface determines a maximum plunger rod insertion depth for the precision dose delivery device; Insertion gauge.

10. The insertion gauge of claim 9 , wherein the receiving block further includes a first receiving surface, the first receiving surface being arcuate.

11. The insertion gauge of claim 10 , wherein the first receiving surface is configured to abut a first portion of an actuation portion of a plunger rod of the precision dose delivery device.

12. The insertion gauge of claim 9 , further comprising a receiving area defined between the first receiving block surface of the receiving block and the first surface of the protruding element.

13. The insertion gauge of claim 12 , wherein a second portion of an actuation portion of a plunger rod of the precision dose delivery device is configured to reside within the receiving area.

14. 10. The insertion gauge of claim 9, wherein the first gauge spacer surface is configured to abut a portion of a plunger rod of the precision dose delivery device and the second gauge spacer surface is configured to abut a portion of a flange component of the precision dose delivery device.

15. A method of assembling a dose delivery device, comprising the steps of: Axially inserting a lower end of a plunger rod into a device body through an opening in a flange portion of said dose delivery device; positioning an insertion gauge laterally adjacent to an upper end of said plunger rod; and applying an axial force to the insertion gauge to move the plunger rod axially into the opening in the flange portion until the insertion gauge abuts the flange portion and the plunger rod; A method comprising:

16. The method of claim 15 , wherein the insertion gauge comprises an insertion gauge body including a handle portion and a gauge portion.

17. The method of claim 16 , wherein the handle portion includes one or more structures to assist a user in gripping the insertion gauge during the positioning.

18. 17. The method of claim 16, wherein the positioning includes positioning one or more plunger rod abutment surfaces of the gauge portion against one or more surfaces of the upper end of the plunger rod.

19. The method of claim 15 , wherein a maximum insertion depth of the plunger rod is determined when the insertion gauge abuts the flange portion and the plunger rod.

20. 16. The method of claim 15, further comprising separating the insertion gauge from the upper end of the plunger rod by moving the insertion gauge laterally, in a direction substantially perpendicular to a direction of the axial force, after the insertion gauge abuts the flange portion and the plunger rod.

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