Precision dose delivery device plunger rod insertion gauge and method thereof

Abstract

A plunger rod insertion gauge for a precise dose delivery device is disclosed. The insertion gauge comprises an insertion gauge body which comprises a handle part and a gauge part; wherein the gauge portion comprises one or more plunger rod abutment surfaces and one or more flange abutment surfaces oriented substantially perpendicular to the plunger rod insertion axis; and wherein a dimension measured between the one or more plunger rod abutment surfaces and the one or more flange abutment surfaces is defined as a maximum plunger rod insertion depth of the precise dose delivery device. Other aspects are described and claimed.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Application No. 63 / 321,901 filed on March 21, 2022 and U.S. Application No. 63 / 342,515 filed on May 16, 2022, both of which are incorporated herein by reference in their entirety. Technical Field

[0002] Various aspects of the present disclosure relate to devices and methods for assembling, priming, or otherwise configuring a dose delivery device, such as a syringe, to facilitate accurate dose delivery. More specifically, embodiments of the present disclosure relate to devices for assisting plunger insertion of an accurate dose delivery device. Background Art

[0003] Drug products including fluid drugs can be delivered to patients in various ways, including via injection. In many cases, the precision and accuracy of the volume of liquid drug products are crucial. For example, medical professionals may be interested in ensuring that approved or prescribed amounts of drugs are consistently delivered to each patient in need of the drug. In addition, an overdose or underdose of the drug given to the patient, even a little bit, may have an adverse (or even negative) clinical effect on the patient. Furthermore, the prescription volume of some drug products is very low (e.g., below about 100 μL). In the case of low doses, human errors in the preparation and delivery of accurate doses of injectable drugs may affect the efficacy of the drug on the patient and the subsequent clinical effect on the patient.

[0004] During assembly of devices for providing these accurate doses of drugs, it is often necessary to insert the plunger into the device body to the appropriate depth. Exceeding this depth can cause the stopper to move, thereby compromising the sealing integrity of the drug delivery device.

[0005] The entire disclosure of commonly owned U.S. Patent No. 11,439,758 is incorporated herein by reference, which discloses a dose delivery device, except for any definitions, subject matter disclaimers, or disclaimers, and unless the incorporated material is inconsistent with the express disclosure herein, in which case the language of the disclosure controls. Summary of the invention

[0006] According to certain aspects of the present disclosure, an insertion gauge device is disclosed that engages with a component of a precision dose delivery device during assembly of the precision dose delivery device.

[0007] In one aspect, a plunger rod insertion gauge for a precision dose delivery device is provided. The insertion gauge comprises: an insertion gauge body including a handle portion and a gauge portion; wherein the gauge portion comprises one or more plunger rod abutment surfaces and one or more flange abutment surfaces, the flange abutment surfaces being oriented substantially perpendicular to the plunger rod insertion axis; and wherein a dimension measured between the one or more plunger rod abutment surfaces and the one or more flange abutment surfaces defines a maximum plunger rod insertion depth for the precision dose delivery device.

[0008] In another aspect, a plunger rod insertion gauge for a precision dose delivery device is disclosed. The insertion gauge includes: 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 member positioned above the receiving block; wherein a dimension between the first gauge spacer surface and the second gauge spacer surface defines a maximum plunger rod insertion depth for the precision dose delivery device.

[0009] In yet another aspect, a method of assembling a dose delivery device is disclosed. The method 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 axially translate the plunger rod into the opening of the flange portion until the insertion gauge abuts the flange portion and the plunger rod.

[0010] 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of plunger insertion devices for assisting precision dose delivery devices, such as during assembly, and together with the description serve to explain the principles of the disclosed embodiments. These drawings show various aspects of the present disclosure.

[0012] Figure 1 Exemplary insertion gauge devices and precision dose delivery devices according to some embodiments of the present disclosure are described.

[0013] Figure 2 A perspective view of an insertion gauge apparatus is depicted according to some embodiments of the present disclosure.

[0014] Figure 3 An exemplary insertion gauge device that engages with a precision dose delivery device according to some embodiments of the present disclosure is described.

[0015] Figure 4An exemplary insertion gauge device having a handle portion according to some embodiments of the present disclosure is described.

[0016] Figure 5 Describe some embodiments of the present disclosure Figure 4 Front view of the insertion gauge device.

[0017] Figure 6 Describe some embodiments of the present disclosure Figure 4 A side view of the insertion gauge apparatus.

[0018] Figure 7 Describe some embodiments of the present disclosure Figure 4 A top view of the insertion gauge apparatus.

[0019] Figure 8 An exemplary flow chart depicts a method of assembling a plunger rod into a body of a drug delivery device containing a predetermined amount of liquid (eg, a formulated drug) using an insertion gauge in accordance with one or more embodiments. DETAILED DESCRIPTION

[0020] As used herein, the words "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 comprising a list of components does not include only those components, but may include other components not expressly listed or inherent to such process, method, article, or apparatus. The word "exemplary" is used in the sense of "example," not "ideal." It is worth noting that the embodiments or implementations described herein as "examples" or "exemplary" should not be construed as preferred or advantageous, for example, over other embodiments or implementations; rather, it is intended to reflect or indicate that these embodiments are an "example," not "ideal." In addition, the words "first," "second," and the like herein do not indicate any order, quantity, or importance, but are used to distinguish a component, structure, step, or process from another. Furthermore, the words "a" and "an" herein do not indicate a limitation in quantity, but rather indicate the presence of one or more. Additionally, "about," "approximately," "substantially," etc., when used to describe a numerical value, means a variation of + / - 10% of the value, unless otherwise specified.

[0021] Embodiments of the present disclosure can be used with any type of fluid-containing products, such as liquid medicine, liquid placebo or other liquids that can be distributed in dosage form.As used herein, the term "drug" can mean a prepared substance including active ingredient or many ingredients, for example, small molecules or macromolecules, such as analgesics, steroids or biologics.As used herein, "biologics" can mean a macromolecule (for example, having a size greater than 15kDa, greater than 30kDa, greater than 50kDa, greater than 75kDa or greater than 100kDa) produced in a living system such as a cell. Biologics can include proteins (such as antibodies), nucleic acids, large carbohydrates, etc. Unlike small molecules that can have a clearly defined chemical structure, biologics can have a highly complex structure that can not be easily quantified with a laboratory method.As used herein, the term "drug product" can mean the volume of the medicine apportioned to the main packaging component, for packaging, transporting, delivering and / or administering to a patient.

[0022] The term "primary packaging component" means a packaging component for a drug product, such as a drug container, that is designed and manufactured to be in direct physical contact with a formulated drug. (See, e.g., Guidance for Industry on Container Closure Systems for Packaging Human Drugs and Biologics, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research (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.

[0023] As used herein, the terms "distal" and "distally" mean a position (or a portion of a device) that is relatively closer to or in the direction of a patient delivery site, and the terms "proximal" and "proximal" mean a position (or a portion of a device) that is relatively closer to or in the direction of a user end, which is opposite to a distal position / portion of the device.

[0024] As used herein, the term "body" when used with reference to a portion of a device may mean a device component suitable for containing a volume of a drug. The body may include, for example, a barrel (such as a syringe barrel), a tube, a cylinder, or another containing portion of the device. For example, in some embodiments, the body may be a syringe barrel made of glass and / or may be a barrel that is free of silicone oil, substantially free of silicone oil, and / or contains 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.

[0025] Embodiments of the present disclosure may be used with products that generally have a small dose volume, such as ophthalmic drug products. In some embodiments, the device of the present disclosure may be used with a drug product comprising an ophthalmic solution, which has, for example, no more than 5 particles with a diameter of ≥25 μm per ml and / or no more than 50 particles with a diameter of ≥10 μm per ml. In some embodiments, the device of the present disclosure may be used with a drug product comprising a macromolecule, such as a molecular weight of 30 kDA or greater. In some embodiments, the device of the present disclosure may be used with a drug product comprising a fragment of a macromolecule. For example, in some embodiments, the device of the present disclosure may be used with a drug product comprising an antigen binding molecule. In some aspects, the antigen binding molecule may be an antibody or an antigen binding fragment. In some embodiments, the device of the present disclosure may be suitable for use with a vascular endothelial growth factor (VEGF) inhibitor and / or a macromolecule and small molecule antagonist of VEGF and / or angiopoietin-2.In some embodiments, the devices of the present disclosure may be suitable for use with a pharmaceutical product comprising ingredients such as 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 source] origin]), epoetin alpha, darbepoetin, filigrastim, golimumab, etanercept, an antigen binding fragment of any of the above, or a combination of such binding domains, in particular a bispecific antibody such as VEGF or angiopoietin-2, etc. Drugs suitable for use with a dose delivery device according to the present disclosure can be used to treat, for example, ocular diseases such as 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 pathological myopia (PM), diabetic macular edema (DME), diabetic retinopathy, or proliferative retinopathy.

[0026] 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-assembling the medicament in the device of the present disclosure can minimize the steps required to prepare the dose for delivery to the patient. During this assembly process, the correct insertion of the plunger rod into the drug delivery device body can prevent undesired stopper movement and support accurate and sterile drug dosage.

[0027] In some embodiments, the device according to the present disclosure can be used to prepare a precision drug delivery device. For example, in some embodiments, the device according to the present disclosure can snap onto a portion of a precision drug delivery device to mechanically prevent over-insertion of a plunger rod into a drug delivery device body.

[0028] Currently in the dose delivery device market, and specifically in the pre-filled syringe market, there is a need for a mechanism that allows a user to accurately set the delivery of a small volume of product in a syringe (e.g., a pre-filled or refillable / refillable syringe) while maintaining the integrity of a closed container. Embodiments of the present disclosure can assist manufacturers, drug product providers, medical professionals, and / or patients in accurately making, filling, or otherwise preparing a dose administration device. Furthermore, embodiments of the present disclosure can assist in preventing or mitigating errors or variations in device manufacturing or use, such as errors in plunger rod insertion and stopper positioning.

[0029] Embodiments or aspects of embodiments disclosed herein can be used in conjunction with existing syringe body parts to modify existing products, which can reduce development and manufacturing time for dose delivery devices. In other cases, embodiments or aspects of embodiments disclosed herein can be provided to users along with them during the manufacture of precision drug delivery devices. The syringes used with the plunger rod insertion gauges described herein can be pre-filled, or can be refillable / refillable.

[0030] In some embodiments, the precise drug delivery device according to the present disclosure may be depicted as including a type of plunger rod and plunger, or as a general schematic diagram including a plunger rod and a plunger. For example, some devices according to the present disclosure may be depicted or described as including, for example, a plunger rod with a ball-tipped end, which engages with a stopper so that the plunger rod and the stopper can be attached together. In some embodiments, the plunger rod and the stopper may not be physically locked to each other. In this way, pushing the plunger rod distally may cause the stopper to move distally, but retracting the plunger rod proximally will not retract the stopper. It is conceivable that the plunger rod insertion gauge may be designed, adjusted and / or configured as needed to be used with plunger rods and stoppers of multiple and / or different configurations.

[0031] View Now Figure 1 , a plunger rod insertion gauge 100 according to an embodiment of the present disclosure is depicted adjacent to an exemplary precision drug delivery device 200. The drug delivery device 200 may include a body 205, and a blocking member in the form of a flange 210 having a proximal collar 215 around an opening through which a plunger rod 220 may pass. The plunger rod 220 may include an actuating portion 225 in the form of a plunger head that may 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 actuating portion 225 may contain a first portion 230 and a second portion 235. The first portion 230 may be toroidal, and the second portion 235 may be cylindrical. The first portion 230 may be longitudinally positioned adjacent to the second portion 235, and the diameter of the first portion 230 may be greater than the diameter of the second portion 235.

[0032] The flange 210 may have any suitable size and / or shape to serve as a blocking member in the drug delivery device 200 to close, partially close, cover, or partially cover an end of the body 205 that is opposite the end from which the drug is expelled and which is also covered by a closure 260 (e.g., a tamper-evident closure). In some embodiments, the flange 210 may include a proximal collar 215 that is configured to engage with the body 205 to hold the flange 210 in an appropriate position relative to the body 205. The proximal collar 215 of the flange 210 may be sized and configured to accommodate 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 past a predetermined point until the plunger rod 220 is rotated to a specific position. Figure 1-2 , the proximal collar 215 may be cylindrical; in alternative embodiments, the proximal collar 215 may have any suitable size or shape compatible with the actuation portion 225. In some embodiments, the flange member 210 may include one or more flanges 245 that may be sized and configured to assist a user in holding the drug delivery device 200 and / or expelling a formulated drug from the drug delivery device 200.

[0033] The plunger rod 220 can be rotated about a central longitudinal axis (e.g., in one direction or in two directions), for example, by grasping and / or twisting the actuation portion 225 of the plunger rod 220 relative to the flange 210 and / or the body 205. In some embodiments, the protrusion 240 can assist a user in grasping and / or twisting the actuation portion 225 relative to the flange 210 and / or the body 205 by providing additional surface area against which the user can grasp and / or push to twist the actuation portion 225. The plunger rod 220 can include a distal tip 250 sized and configured to push, attach to, or otherwise engage with a stopper 255. The stopper 255 can form part of a seal between the substance 265 and the environment, an aspect of the CCI required to maintain drug safety and efficacy. Proper stopper positioning and appropriate restriction of movement that could compromise the CCI can be beneficial in ensuring consistent filling and proper sealing.

[0034] According to the present disclosure, a plunger rod insertion gauge ("insertion gauge") 100 may be associated with the precision drug delivery device 200 to assist in proper plunger rod insertion during insertion of the plunger rod 220, which in turn may assist in proper stopper positioning and maintenance of the CCI. The plunger rod insertion gauge 100 may be shaped to cooperate with one or more surfaces of the flange 210, the proximal collar 215, and / or the actuation portion 225 of the plunger rod 220 so that when engaged (e.g., Figure 3 ), preventing the plunger rod 220 from being inserted into the precision dose delivery device body 200 beyond a desired amount, thereby limiting the maximum plunger rod insertion depth of the plunger rod 220.

[0035] Figure 2 An exemplary plunger rod insertion gauge 100 in accordance with the present disclosure is described. The insertion gauge 100 may include gauge spacers 105 positioned substantially opposite to one another. Each gauge spacer 105 in the insertion gauge 100 may include a first surface 110 and a second surface 115. The second surface 115 may be positioned opposite to the first surface 110, and both the first surface 110 and the second surface 115 may be substantially flat.

[0036] The insertion gauge 100 may also include a receiving block 120 positioned adjacent to the gauge spacer 105. The receiving block 120 may contain 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 that matches 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 defined 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 the second surface 115 of the gauge spacer 105, or may 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.

[0037] The insertion gauge 100 may also include a protruding member 155 that may extend into the space between the protrusion of the gauge spacer 105 and the first horizontal surface 140 and above the receiving wall 125 in a direction away from the second receiving wall 160. The second receiving wall 160 may be positioned between the first horizontal surface 140 of the receiving block 120 and the first protruding surface 165 of the protruding member 155.

[0038] 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, so 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 align / contact the receiving wall 125 of the receiving block 120 of the insertion gauge 100. 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, as further illustrated and described herein. In addition, when aligned, the first portion 230 of the actuation portion 225 can fit within the space between the first horizontal surface 140 and the first protruding surface 165 of the protruding member 155. In some embodiments, the first portion 230 of the actuating portion 225 may be in contact with the second receiving wall 160 .

[0039] The height 175 of the gauge spacer 105 can be used as a critical dimension of the plunger rod insertion gauge 100, which determines the depth to which the plunger rod 220 can be inserted into the body 205 of the drug delivery device 200. Accordingly, the height of the gauge spacer 105 can be inversely proportional to the insertion depth of the drug delivery device 200. More specifically, a higher height of the gauge spacer 105 corresponds to a shallower insertion depth of the plunger rod 220, and vice versa.

[0040] The height 175 of the gauge spacer 105 can be changed between many insertion gauges according to the maximum plunger rod insertion depth required. For example, in the case where the drug solution of the first volume needs to be deployed, an insertion gauge A with a first height can be used, and in the case where the drug solution of the second volume needs to be deployed, an insertion gauge B with a second higher height can be used. The specific profile of the insertion gauge 100 (that is, the various profiles and / or sizes of the insertion gauge 100) can be common to various drug delivery devices, or can be customized to more closely match a specific plunger rod design. For example, the surface features of the actuating parts of the plunger rod for the dose delivery device A can be different from the surface features of the actuating parts of the plunger rod for the dose delivery device B. In this case, two separate plunger rod insertion gauges can be used, wherein the profile of each insertion gauge is shaped to meet the surface features of its respective dose delivery device. To support reuse of the insertion gauge, the insertion gauge can be made of a material such as plastic and / or rubber that is compatible with the assembly environment (i.e., capable of being sterilized and resistant to any solvents used) but also does not damage the drug delivery device components so as to avoid leaving marks or causing damage to the drug delivery device.

[0041] Figure 3The plunger rod insertion gauge 100 is described as interacting with the actuation portion 225 of the plunger rod 220 to define the position of the plunger rod 220. Once the plunger rod 220 is inserted to the desired depth (defined by the insertion gauge 100 employed), one or more surfaces of the plunger rod insertion gauge 100 will interfere with one or more surfaces of the flange 210 (e.g., such as the top surface 275 of the proximal collar 215) and / or one or more surfaces of the actuation portion 225 (e.g., the bottom surface 270 of the protrusion 240 of the actuation portion 225). At this point, the plunger rod 220 and / or the stopper 255 will be blocked from further longitudinal movement into the device body 205, thereby defining the final expelled volume of the compounded drug 265, and the plunger rod insertion gauge 100 can be disengaged. In some embodiments, the insertion gauge 100 may not be fixedly locked (e.g., may not be frictionally attached (e.g., via a snap fit)) to the actuation portion 225 of the plunger rod 220, but may instead be freely translatable independently from 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. Thus, the plunger rod insertion gauge 100 may be reusable for subsequent filling of the same or a different drug delivery device.

[0042] Figure 4 An exemplary plunger rod insertion gauge 300 having a handle is described, which includes an extension portion configured for use as a handle. The handle portion 305 can extend from a surface of the insertion gauge portion 310 that is opposite the side of the precision drug delivery device 200 that is configured to abut against the plunger rod. The shape of the handle portion 3051 is configured to allow a user to firmly grasp the gauge 300, which can assist in positioning the insertion gauge portion 310 against the plunger rod, applying axial force to the insertion gauge portion 310, and separating the insertion gauge portion 310 from the actuation portion 225 of the plunger rod. In some embodiments, the size and shape of the handle portion 305 can be varied to better fit the user's hand. Figure 4 As described in , the end of the handle portion 305 may include a downward projection 315 to prevent the insertion gauge portion 310 from slipping out of the user's hand. Other features to better fit the user's hand can include, for example, adding one or more of the following: finger indentations, surface finishes for improved grip, and / or through holes through which fingers or straps can pass.

[0043] Now read together Figure 5-7 , according to the present disclosure, providing Figure 4 Various views of an insertion gauge 300 having a handle are illustrated in FIG. Figure 5A front view of the insertion gauge 300 with a handle is depicted. From this perspective, the height 320 of the insertion gauge 300 with a handle can be seen. Although the height 320 can be nearly any height, in some embodiments, the height can 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, about 40 mm. In one embodiment, the height can be 35.93 mm. Figure 6 A side view of the insertion gauge 300 with a handle is depicted. From this perspective, the length 325 of the insertion gauge 300 with a handle can be seen. Although the length 325 can be nearly any length, in some embodiments, the length can be about 80 mm to about 120 mm, about 90 mm to about 100 mm. In one embodiment, the length can be 100 mm. Figure 7 A top view of an insertion gauge 300 with a handle is depicted. From this perspective, a maximum width 330 of the insertion gauge portion 310 of the insertion gauge 300 with a handle can be perceived. Although the maximum width 330 can be nearly any width, in some embodiments, the width can 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, about 40 mm. In one embodiment, the maximum width can be 35 mm.

[0044] Figure 8 A flow chart is depicted illustrating an exemplary method 800 of assembling a plunger rod into a body of a drug delivery device containing a predetermined amount of liquid (eg, a formulated drug) using an insertion gauge in accordance with one or more embodiments of the present disclosure.

[0045] At step 805, the plunger rod 220 of the drug delivery device 200 may be inserted into the device body 205 containing the liquid (eg, the formulated drug 265). During this step, the insertion gauge 100 or 300 may be selectively positioned laterally adjacent to the actuation portion 225 of the plunger rod 220.

[0046] At 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 may 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 member 155. In the 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.

[0047] At step 815, an axial force may be applied to the insertion gauge 100 to translate the plunger rod 220 downward to a second position in which the second surface 115 of the gauge spacer 105 abuts the top surface 275 of the proximal collar 215 of the flange member 210 of the drug delivery device 200. The application of force may cause the first protruding surface 165 of the protruding member 155 to contact the top surface of the first portion 230 of the actuation portion 225, thereby causing the plunger rod 220 to move downward into the body 205 of the drug delivery device 200. At step 805, liquid in the drug delivery device 200 may be expelled from the drug delivery device 200 until contact between the second surface 115 of the gauge spacer 105 and the top surface 275 of the proximal collar 215 is achieved. The remaining liquid in the drug delivery device 200 after the force is applied may define a dose volume.

[0048] At step 820, the insertion gauge 100 or 300 can be separated from the actuation portion 225 of the plunger rod 220. More specifically, the insertion gauge 100 can be translated laterally in a direction substantially perpendicular to the direction of the force applied at step 815.

[0049] The components of the devices described herein may be designed and / or adapted for manufacture in more than one manner. For example, in some embodiments, the plunger rod insertion gauge may be adapted for manufacture via, for example, injection molding, 3D printing, or machining. For example, precision may be particularly important to ensure proper fit and range of motion of the plunger rod during insertion.

[0050] Embodiments of the present disclosure may include the following features:

[0051] Item 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; wherein the gauge portion includes one or more plunger rod abutment surfaces and one or more flange abutment surfaces oriented substantially perpendicular to the plunger rod insertion axis; and wherein a dimension measured between the one or more plunger rod abutment surfaces and the one or more flange abutment surfaces defines a maximum plunger rod insertion depth for the precision dose delivery device.

[0052] Item 2. The insertion gauge of 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 that is seated between a top surface of the plunger rod and a top surface of a flange portion of the precision dose delivery device.

[0053] 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 a top surface of the plunger rod.

[0054] Item 4. The insertion gauge of Item 2, wherein the portion of the plunger rod is a protruding member, and wherein the one or more plunger rod abutment surfaces include at least one surface configured to abut a bottom surface of the protruding member.

[0055] Item 5. The insertion gauge of Item 2, wherein one or more of the plunger rod abutment surfaces include a first receiving surface and a second receiving surface, and wherein the portion of the plunger rod includes a first actuation portion and a second actuation portion, wherein the first actuation portion is toroidal, and wherein the second actuation portion is cylindrical.

[0056] 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, and wherein the second receiving surface is configured to abut the first actuation portion of the plunger rod, wherein the first receiving surface is positioned below the second receiving surface.

[0057] Item 7. The insertion gauge of Item 2, wherein the top surface of the flange portion is a top surface of a proximal collar of the flange portion.

[0058] Item 8. The insertion gauge of Item 1, wherein the handle portion includes one or more features to assist a user in grasping the insertion gauge.

[0059] Item 9. A plunger rod insertion gauge for a precision dose delivery device, the insertion gauge comprising: 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 member positioned above the receiving block; wherein a dimension between the first gauge spacer surface and the second gauge spacer surface defines a maximum plunger rod insertion depth for the precision dose delivery device.

[0060] Item 10. The insertion gauge of Item 9, wherein the receiving block further comprises a first receiving surface, and wherein the first receiving surface is arc-shaped.

[0061] 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 a precision dose delivery device.

[0062] 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 member.

[0063] Item 13. The insertion gauge of Item 12, wherein the second portion of the actuation portion of the plunger rod of the precision dose delivery device is configured to reside in the receiving area.

[0064] Item 14. The insertion gauge of Item 9, wherein the first gauge spacer surface is configured to abut a portion of a plunger rod of a precision dose delivery device, and wherein the second gauge spacer surface is configured to abut a portion of a flange component of the precision dose delivery device.

[0065] Item 15. A method of assembling a dose delivery device, the method comprising: 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 an upper end of the plunger rod; and applying an axial force to the insertion gauge to axially translate the plunger rod into the opening in the flange portion until the insertion gauge abuts the flange portion and the plunger rod.

[0066] Item 16. The method of Item 15, wherein the insertion gauge comprises an insertion gauge body, the insertion gauge body comprising a handle portion and a gauge portion.

[0067] Item 17. The method of Item 16, wherein the handle portion includes one or more features to assist a user in grasping the insertion gauge during positioning.

[0068] Item 18. The method of Item 16, wherein the positioning comprises 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.

[0069] Item 19. The method of Item 15, wherein a maximum insertion depth of the plunger rod is defined when the insertion gauge abuts the flange portion and the plunger rod.

[0070] 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 translating the insertion gauge laterally in a direction substantially perpendicular to the axial force.

[0071] Many features and advantages of the present disclosure are apparent from the detailed description, and thus, it is intended that the appended claims cover all such features and advantages of the present disclosure that fall within the true spirit and scope of the present disclosure. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the present disclosure to the exact construction and operation illustrated and described, and thus, all suitable modifications and equivalents falling within the scope of the present disclosure may be resorted to.

[0072] The device of the present disclosure is operable to assist in providing consistent and accurate plunger rod insertion for a drug delivery device. Those skilled in the art will appreciate that the concepts based on the present disclosure can be easily used as a basis for designing other devices, methods, and systems to implement the purposes of the present disclosure. Therefore, the claims should not be construed as being limited by the foregoing description.

Claims

1. A plunger rod insertion gauge for a precision dose delivery device, the insertion gauge comprising: Insert the gauge body, including the handle portion and the gauge portion; wherein the gauge portion includes one or more plunger rod abutment surfaces and one or more flange abutment surfaces oriented substantially perpendicular to the plunger rod insertion axis; and The dimension measured between the one or more plunger rod abutment surfaces and the one or more flange abutment surfaces is defined as the maximum plunger rod insertion depth of the precision dose delivery device.

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 a plunger rod, the portion of the plunger rod being seated between a top surface of the plunger rod and a top 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 member, and wherein the one or more plunger rod abutment surfaces includes at least one surface configured to abut a bottom surface of the protruding member.

5. An insertion gauge as described in claim 2, wherein the one or more plunger rod abutment surfaces include a first receiving surface and a second receiving surface, and wherein the portion of the plunger rod includes a first actuating portion and a second actuating portion, wherein the first actuating portion is an annular surface, and wherein the second actuating portion is cylindrical.

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

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

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

9. A plunger rod insertion gauge for a precision dose delivery device, the insertion gauge comprising: a gauge spacer comprising a first gauge spacer surface and a second gauge spacer surface; a receiving block positioned adjacent the gauge spacer and including a first receiving block surface and a second receiving block surface; as well as a protruding member positioned above the receiving block; The dimension between the first gauge spacer surface and the second gauge spacer surface defines a maximum plunger rod insertion depth of the precision dose delivery device.

10. The insertion gauge of claim 9, wherein the receiving block further comprises a first receiving surface, and wherein the first receiving surface is arc-shaped.

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 member.

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

14. 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 wherein 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, the method comprising: axially inserting the lower end of the plunger rod into the device body through an opening in the flange portion of the dose delivery device; positioning an insertion gauge laterally adjacent an upper end of the plunger rod; and An axial force is applied to the insertion gauge to axially translate the plunger rod into the opening in the flange portion until the insertion gauge abuts the flange portion and the plunger rod.

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 said handle portion includes one or more features to assist a user in grasping said insertion gauge during said positioning.

18. The method of claim 16, wherein the positioning comprises 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 defined when the insertion gauge abuts the flange portion and the plunger rod.

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

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