Liquid drug administration device

Abstract

The present invention relates to a liquid drug delivery device, the device comprising: a body configured to receive and support a drug container; wherein the body comprises an aperture; the aperture comprises a viewing window that is aligned with the drug container when the drug container is present; and the device is configured such that the size of the viewing window is adjustable. Additionally, related methods of manufacture are also disclosed.

Description

[Technical Field]

[0001] This invention relates to a liquid drug administration device. [Background technology]

[0002] Liquid drug administration devices, such as automated injection devices, can take various forms. Typically, they include one or more windows that allow the amount of drug in the device to be seen during drug administration. For example, the piston in the syringe can be seen as the piston rod is pushed down. [Overview of the project] [Means for solving the problem]

[0003] In a first embodiment, a liquid drug dispensing device is provided, comprising a body configured to house and support a drug container; wherein the body comprises an aperture; the aperture comprises a viewing window that aligns with the drug container when the drug container is present; and the device is configured such that the size of the viewing window is adjustable.

[0004] Therefore, a machine or assembly worker can adjust the size of the viewing window relative to the initial amount of drug in the drug container, for example, to conceal the empty portion of the drug container. Thus, a single device configured to accommodate various drug amounts is provided. The main body is manufactured as a single piece, for example, by molding. Thus, a single manufacturing component is applied to accommodate drug containers of the same size but with various initial drug amounts. This allows for the standardization of both the device and the drug container, so that the same type of device and drug container can be used regardless of the amount of drug to be administered. Therefore, there is no need to redesign or rework for different applications. Typically, the device is configured such that the viewing window is sizing-adjustable during the assembly of the device but not by the end user. Unwanted alteration of the viewing window by the end user or a third party is thus prevented.

[0005] The main body is configured to directly house and support the drug container. Alternatively, the main body can be configured to indirectly house and support the drug container. For example, the main body can be configured to house and support an inner carrier which is configured to house and support the drug container.

[0006] The drug container may be a syringe or cartridge, such as a sealed vial or a flexible cartridge. Typically, the drug container is a syringe, which includes a hollow cylinder for holding the drug, a piston that can move within the cylinder, a piston rod connected to the piston to actuate the piston, and an outlet port located distal to the piston and in fluid communication with the inside of the cylinder.

[0007] In some cases, the drug container is configured so that the inside of the drug container can be viewed through a viewing window when the drug container is inside the device. For example, one or more walls defining the drug container may be transparent, in which case at least one transparent wall aligns with the viewing window when the drug container is inside the device. If the drug container is a syringe as described above, typically the hollow cylinder is transparent.

[0008] In one embodiment, the viewing window is configured to allow viewing of the amount of drug in a drug container, if one is present. The drug itself may be visible, and / or an indicator indicating the amount of drug. By allowing the drug itself to be visible, the end user can check for contamination or deterioration of the drug, and / or for undesirable air bubbles in the drug. This prevents the delivery of drug that does not meet the optimal conditions. However, in other embodiments, the indicator indicating the amount of drug may be visible, but the drug itself may not be visible. For example, if the drug container is a syringe, an indicator attached to the piston rod may be visible. Such embodiments are used for drugs where the delivery rate is critical, allowing the end user to check the drug and avoid potential excessive delays in administration.

[0009] The device body may include two or more apertures. Each aperture includes a separate viewing window that aligns with the drug container when one is present. Typically, the device includes two such apertures located on opposite sides of the device. This allows the end user to view the drug and / or the amount of drug in the container without having to orient the device in a specific direction.

[0010] Typically, the device is configured such that the size of the viewing window is adjustable in relation to the amount of drug in the container. In some cases, the size of the viewing window may be adjustable by one or more pre-forming elements. For example, the device may include an insertable or removable element configured to conceal the empty portion of the drug container.

[0011] If the drug container is a syringe, the device is configured such that the size of the viewing window adjusts to conceal the piston rod when the syringe contains the desired amount of liquid drug to be administered. In some cases, the viewing window may adjust to conceal the piston and piston rod when the syringe contains the desired amount of liquid drug to be administered. Such a configuration avoids unintended confusion, concern, or frustration for the end user of the device, who might mistakenly believe that an insufficient dose has been supplied if the piston rod and / or piston is visible in the viewing window before dispensing. The device may further be configured such that the size of the viewing window adjusts to reveal the piston as the piston rod is pushed down during drug administration. In one embodiment, the device is configured such that the size of the viewing window adjusts to reveal the piston when the piston rod is fully pushed down. Alternatively, the device may be configured such that the size of the viewing window adjusts to conceal the piston when the piston rod is fully pushed down. Therefore, one embodiment can be provided in which the device is configured such that the size of the viewing window is adjusted to conceal the piston when the syringe contains the desired amount of liquid drug to be administered and when the piston rod is fully depressed, but to allow the piston to be visible at all intermediate positions, i.e., when the piston rod is depressed. This embodiment allows the end user to easily confirm the amount to be administered and, furthermore, avoids unintended confusion, concern, or frustration before administration, as described above.

[0012] Typically, the device is configured so that sizing is performed only once, i.e., the size of the viewing window is adjusted irreversibly. This prevents intervention on the viewing window after the assembly process.

[0013] The device may include a proximal and distal end, with its longitudinal axis extending from the proximal to the distal end, and in some cases, the aperture may be elongated and located parallel to the longitudinal axis of the device. Typically, the elongated aperture is located between the proximal end of the device and the midpoint between the proximal and distal ends of the device.

[0014] In one embodiment, the aperture is configured to receive one or more inserts, the one or more inserts, which partially obscure the aperture to reduce the size of the viewing window when they are present.

[0015] The aperture is configured to accept multiple inserts. Alternatively, the aperture can be configured to accept a single insert, and may even accept a single insert of varying sizes. Typically, one or more inserts conceal the distal end of the aperture.

[0016] In most embodiments, one or more inserts are assumed to be opaque, but in some embodiments, at least one insert may be partially opaque and partially transparent, or the device may be configured to receive multiple inserts, at least one of which is opaque and at least one is transparent. In such embodiments, a viewing window may be positioned to coincide with a transparent insert or a transparent portion of an insert. Optionally, the drug and / or amount of drug in the container may be visible through the transparent insert or a transparent portion of an insert. For example, an aperture may be configured to receive a single insert having a transparent portion and an opaque portion that traverses the entire aperture.

[0017] One or more inserts and bodies may include cooperative features that enable the fixation of the insert within an aperture. Typically, once the insert is fixed within the aperture, the cooperative features are not accessible from outside the device. In some cases, the cooperative features enable the press-fitting of the insert in a direction roughly perpendicular to the surface of the body. Using such cooperative features facilitates the quick and easy fixation of the insert by a machine or assembly worker during device assembly.

[0018] One or more inserts may include one or more elastic tabs. One or more elastic tabs engage in one or more corresponding recesses in one or more sidewalls defining the aperture. Typically, the elastic tabs are pressed down when one or more inserts are inserted into the aperture, and then, upon reaching a predetermined position, the tabs expand into their corresponding recesses, thereby locking one or more inserts in place.

[0019] Alternatively, or in addition, the sidewall of the aperture may include one or more elastic tabs that engage with one or more corresponding recesses in the insert.

[0020] The aperture may be elongated and may include a first sidewall and a second sidewall, each of which extends in a direction substantially parallel to the longitudinal axis of the device, the first sidewall including a first recess for engaging with a first elastic tab, the second sidewall including a second recess for engaging with a second elastic tab, and the first insert including both the first and second elastic tabs.

[0021] Depending on the case, the first and second side walls each have surfaces that lie in a plane extending radially and approximately parallel to the longitudinal axis of the device.

[0022] The longitudinal length of at least one recess in one side wall can correspond substantially to the length of the corresponding elastic tab that engages the recess so that the insert attached to the elastic tab does not move longitudinally. Thus, the number of cooperating functions is minimized, thereby reducing the complexity of the insert. Such an arrangement of the elastic tab and the recess can further predetermine the exact position of the insert within the aperture, thus simplifying the assembly process.

[0023] Alternatively, the first and second recesses can together form a track that extends generally longitudinally with respect to the longitudinal axis of the device, and the first and second elastic tabs of the first insert can engage the track at any position along its length, and the first insert further includes a connecting element applied to engage a corresponding connecting element at the end of the aperture, possibly via one or more intermediate inserts, so that the first insert does not move longitudinally. Such an arrangement allows the viewing window of a single body component to be adjusted to accommodate various longitudinal dimensions using only two types of standardized inserts. Thus, a modular system is created. Using a single first insert, a first longitudinal dimension can be obtained. By further including one or more standardized intermediate inserts, a plurality of longitudinal dimensions less than the first longitudinal dimension can be obtained depending on the number of intermediate inserts used. If it is desired to manufacture a liquid drug administration device with viewing windows of different sizes, the manufacturing cost is significantly reduced by being able to achieve such changes using only two types of inserts.

[0024] In some cases, the connecting element and the corresponding connecting element can be connected by pressing and fitting a first insert in a direction substantially orthogonal to the surface of the body. For example, the connecting element and the corresponding connecting element can include male and female connecting parts, or vice versa, such as a hook and a corresponding hole for receiving the hook, or a T-shaped piece and a corresponding notch for receiving the T-shaped piece. Thereby, the connecting element and the elastic tab / depression can be engaged simultaneously with the same pressing and fitting operation, thereby increasing the efficiency in assembly, particularly in mechanical assembly.

[0025] Typically, the end of the aperture that includes the corresponding connecting element is the distal end of the aperture.

[0026] The aperture is further configured to receive one or more intermediate inserts, and each intermediate insert includes a connecting element substantially identical to the connecting element of the first insert and a corresponding connecting element substantially identical to the corresponding connecting element at the end of the aperture. In some cases, each intermediate insert further includes a first elastic tab for engaging a first recess and a second elastic tab for engaging a second recess.

[0027] The dimensions of the size adjustment viewing window are defined in part by the edge of the aperture and in part by the edge of the insert.

[0028] Alternatively, one of the inserts can include an aperture that defines only the dimensions of the size adjustment viewing window.

[0029] In some cases, the body forms the outer case of the device.

[0030] The body may include one or more removable segments adjacent to the aperture, the removable segments configured to extend the aperture by removal in order to increase the size of the viewing window. Thus, the body, manufactured as a single piece, such as a molded body, is provided such that the removable inserts can be removed by a machine or assembly worker to adjust the viewing window to the desired dimensions. Thus, such a single manufacturing component can be adapted to accommodate drug containers with various initial drug volumes.

[0031] Typically, the main body includes multiple detachable segments. Typically, the detachable segments are opaque.

[0032] If the aperture is elongated and positioned parallel to the longitudinal axis of the device, one or more attachment / detachment segments are positioned at the distal end of the aperture so that removal extends the aperture distally.

[0033] The detachable segments are attached to the main body via breakable elements. The assembly process is simplified by using breakable elements that allow the detachable segments to be broken or punched out by a machine or assembly worker. Furthermore, the use of breakable elements allows the main body and detachable segments to be manufactured as a single component, for example, in a single molding process from plastic.

[0034] If the main body includes one or more detachable segments, the main body may form an inner carrier within an outer case, the outer case including a second aperture, and both the aperture of the main body and the second aperture of the outer case include a viewing window.

[0035] In such a configuration, the dimensions of the size-adjustable viewing window are defined overall by the dimensions of the inner carrier aperture after the removal of a desired number of segments. Alternatively, the dimensions of the size-adjustable viewing window are defined partly by the dimensions of the second aperture of the outer case and partly by the dimensions of the inner carrier (body) aperture after the removal of a desired number of segments.

[0036] The second aperture is configured such that, when the inner carrier is placed inside the outer case, any remaining detachable segments cannot be removed from the inner carrier. For example, the tangential width of the detachable segments may be greater than the tangential width of the second aperture. Alternatively, bars can be provided that extend tangentially at intervals across the second aperture. This further prevents any remaining segments from being removed by the end user.

[0037] The device may include a drug container for holding a drug. For example, the device may include a syringe for holding a drug.

[0038] The device can be an automated injection device.

[0039] In a second embodiment, a method for manufacturing a liquid drug delivery device is: To provide a liquid drug dispensing device comprising a body configured to house and support a drug container, wherein the body comprises an aperture, and the aperture comprises a viewing window that aligns with the drug container when the drug container is present; Adjusting the size of the viewing window and Includes.

[0040] Liquid drug delivery devices and drug containers of a second aspect of this disclosure may be as described in relation to the first aspect of this disclosure.

[0041] Exemplary embodiments of the present invention will be described with reference to the accompanying drawings. [Brief explanation of the drawing]

[0042] [Figure 1A] This is a perspective view of the first liquid drug delivery device and the corresponding insert. [Figure 1B] Figure 1A is a perspective view of the back of the insert. [Figure 1C] This is a partial cross-sectional view of the first device and the insert to which the insert is to be attached. [Figure 2A] This is a perspective view of the second liquid drug delivery device and the corresponding insert. [Figure 2B] This is a partial cross-sectional view of the second device and the insert to which the insert is to be attached. [Figure 2C] This is a partial top view of the second device, with the insert in place. [Figure 3] This is a perspective view of a third liquid drug delivery device and a corresponding insert. [Figure 4A] This is a perspective view of the fourth liquid drug delivery device and the corresponding inner carrier with the breakable segment removed. [Figure 4B] This figure includes a side view and a side section view of the inner carrier of Figure 4A, to which a breakable segment is attached. [Modes for carrying out the invention]

[0043] Exemplary embodiments of the present disclosure provide a liquid drug dispensing device in which the size of a viewing window for viewing the amount of drug in the device can be adjusted during manufacturing.

[0044] Such devices can be used for administering a wide range of liquid medications, where the dosage of the administered liquid drug can vary considerably. For manufacturing purposes, it is desirable to provide devices suitable for use with a wide variety of drug types and dosages. Therefore, it is known to provide a large, set-size viewing window that allows for observation of large or small variations in dosage. However, when small dosages are required, only a small portion of the viewing window will be used, and the remaining portion will be unnecessary for those requirements. In the case of syringes, for example, if a small volume of a larger-capacity syringe is used, the remaining unused portion of the syringe will also be visible through the viewing window. Specifically, the syringe piston and / or piston rod may be visible through the viewing window before drug administration. This may cause anxiety in the end-user that a portion of the device is empty, i.e., that an insufficient dosage will be administered. In the worst case, this anxiety may lead to repeated attempts to administer the drug from multiple devices, potentially resulting in the administration of an overdose.

[0045] To address the aforementioned problems, various designs of dispensing devices are provided, including those with viewing windows of various dimensions or syringes of various diameters to accommodate different amounts of medication. However, such design variations significantly increase manufacturing costs and complexity. This disclosure overcomes at least these problems by providing a single device that can be quickly configured for various drug dosages.

[0046] According to one aspect of the present disclosure, Figures 1A, 1B, and 1C show a first exemplary liquid drug administration device 101. The device 101 as described above includes a body 102. The body 102 also forms the outer case of the device and is configured to house and support a drug container, such as a syringe (not shown). The drug container, when in a predetermined position, is located inside the body in a cavity indicated by 113 in Figure 1C. The body includes an aperture 103. The aperture 103 defines a viewing window through which the drug container can be seen when it is present. The device further includes an insert 104. The insert 104 is positioned within the aperture 103 to reduce the size of the aperture and partially conceal the view of the drug container. Thus, the insert 104 reduces the size of the viewing window after it has been in a predetermined position.

[0047] Typically, the insert 104 is positioned within the aperture during the manufacturing of the device to select a viewing window of appropriate size, taking into account the amount of medication in the medication container. In this way, the empty portion of the medication container can be obscured to avoid misunderstanding by the end user.

[0048] A drug container is typically a syringe containing a piston (also called a plunger or stopper). The piston can be observed through a viewing window. Typically, the size of the viewing window is chosen to essentially correspond to the longitudinal stroke of the piston in the syringe when administered. Obviously, the larger the amount of drug in a given syringe, the greater the longitudinal stroke of the piston when administered. Therefore, larger drug amounts require a longer viewing window than smaller drug amounts.

[0049] For retention of the insert 104 in place, the insert 104 includes elastic tabs 105 and 106. The elastic tabs 105 and 106 engage with corresponding recesses 107 and 108 in the side walls 109 and 110 of the aperture 103. The elastic tabs are thin and rectangular in shape. When the insert 104 is fixed in place with respect to the longitudinal axis of the device, the elastic tabs 105 and 106 have longitudinal dimensions that are greater than their radial dimensions and also greater than their tangential dimensions.

[0050] It should be noted that the side walls 109 and 110 are inclined relative to each other such that each opposing side wall extends approximately radially from the center of the device. This facilitates easy positioning of the insert during manufacturing.

[0051] As shown in Figure 1C, the elastic tabs 105 and 106 are located on the tangential edge of the insert 104 and are attached to the rest of the insert at a location proximal to the longitudinal axis of the device during insert insertion. The cross-sections of the elastic tabs 105 and 106 are bulbous, and their largest tangential dimensions are located distal to their attachment points. The bulbous cross-sections correspond to the concave cross-sections of the recesses 107 and 108. The elastic tabs are formed from a flexible and elastic material, such as plastic, which gives the tabs their elastic properties.

[0052] The insert 104 further includes cavities 114 and 115. The cavities 114 and 115 are located closer to the inside of the elastic tabs 105 and 106, so that when the insert is pressed into place, the elastic tabs temporarily deform inward into the cavities and then spring outward into the corresponding recesses 107 and 108, thereby holding the insert in place.

[0053] The arrangement of the elastic tabs 105 and 106 and the corresponding recesses 107 and 108 described above prevents the removal of the insert 104 after it has been attached to the body 102. Once it is in place, there is no access to the elastic tabs 105 and 106, and therefore the elastic tabs are no longer pushed down to facilitate removal. Thus, the insert 104 cannot be removed without damaging the insert 104 and / or the body 102. This prevents intervention by the end user or intermediary in altering the size of the viewing window.

[0054] As shown in the figure, the body or outer case 102 is substantially cylindrical and has a substantially constant diameter along the longitudinal axis X. However, the three-dimensional configuration of the body or outer case is not important, and other typically elongated three-dimensional structures can also be envisioned, such as those having substantially square or hexagonal cross-sections, and / or those whose diameters and / or cross-sectional shapes differ along their longitudinal axes.

[0055] Figure 1B shows the insert 104 positioned upside down with respect to the viewpoint shown in Figure 1A. As best illustrated by Figure 1B in relation to Figure 1A, the longitudinal length of the elastic tab 106 is approximately equal to the longitudinal length of the corresponding recess 108. Thus, once in place, the elastic tab locks within the recess, and the length of the recess prevents the insert 104 from moving longitudinally within the aperture 103.

[0056] As shown in the figure, the side walls of the aperture defining the viewing window and the end walls of the insert 104 are inclined, so that the end user can view through the viewing window from various angles.

[0057] The device may further include a function to enable the injection of medication from a medication container, such as a needle (not shown) located at the proximal end 111 of the main body. At the opposite distal end 112, there is an actuator (not shown), which is, for example, a button that, when pressed down, initiates the injection of medication from the medication container.

[0058] In the exemplary embodiment described above, the insert 104 is secured within the aperture using elastic tabs 105 and 106 and corresponding recesses 107 and 108, but it will be understood that alternative cooperating functions may also be used. For example, the elastic tabs and corresponding recesses may be located in different positions on the sidewalls of the insert / aperture than those shown. Alternatively, the sidewalls 109 and 110 of the aperture may include one or more elastic tabs positioned within one or more corresponding recesses of the insert 104.

[0059] Other cooperating functions may also be used. For example, the insert may be screwed into place within the aperture or secured by expandable rivets. Inelastic locating tabs may be used on the insert and / or body, which can rotate to engage with corresponding recesses on the corresponding surfaces of the body or insert. The insert may be joined to place by friction fitting and / or adhesive, or by heat welding. Other fastening methods are also apparent.

[0060] Figures 2A, 2B, and 2C show a second exemplary liquid drug dispensing device 201. Again, the device includes a body 202 that forms the outer case of the device. The body further includes an aperture 203. The body is configured to house and support a drug container (not shown) inside the body 202, as described with respect to the first exemplary embodiment. The aperture defines a viewing window that allows the drug container to be seen when it is in place. The device further includes a plurality of inserts 204, 205, and 206. The plurality of inserts 204, 205, and 206 can be positioned within the aperture to reduce the dimensions of the viewing window. The inserts are opaque and therefore prevent any empty portion of the drug container from being seen when not in use.

[0061] To hold the insert within the device body, the end insert 204 includes elastic tabs, for example, 208 and 209. The elastic tabs engage with corresponding recesses 210 and 211 in the side walls 212 and 213 of the aperture 203. The elastic tabs are thin and rectangular in shape. When the insert 204 is fixed in place relative to the longitudinal axis of the device, the elastic tabs 208 and 209 have longitudinal dimensions that are greater than their radial dimensions and also greater than their tangential dimensions. As shown in Figure 2B, the elastic tabs 208 and 209 are located on the tangential edges of the insert 204 and are attached to the remainder of the insert at a distal location relative to the longitudinal axis of the device when the insert is inserted.

[0062] The elastic tabs 208 and 209 include projections positioned within the corresponding recesses 210 and 211. The projections extend tangentially outward from the elastic tabs and, when the insert 204 is in place, extend along the length of the elastic tabs in a direction approximately parallel to the longitudinal axis X of the device, and are located at the innermost end of the elastic tabs with respect to the longitudinal axis X of the device. Again, the elastic tabs are formed from a flexible and elastic material, such as plastic, which gives the tabs their elastic properties.

[0063] The insert 204 further includes cavities 221 and 222. The cavities 221 and 222 are located closer to the inside of the elastic tabs 208 and 209, so that when the insert is pressed into place, the elastic tabs temporarily deform inward into the cavities and then spring outward into the corresponding recesses 210 and 211, thereby holding the insert in place.

[0064] The arrangement of the elastic tabs 208 and 209 and the corresponding recesses 210 and 211 described above prevents the removal of the insert 204 after it has been attached to the body 202. Once it is in place, there is no access to the elastic tabs 208 and 209, and therefore the elastic tabs are no longer pushed down to facilitate removal. Thus, the insert 204 cannot be removed without damaging the insert 204 and / or the body 202. This prevents intervention by the end user or intermediary in altering the size of the viewing window.

[0065] In this exemplary embodiment, as best shown in Figure 2c, recesses 210 and 211 together form a track extending longitudinally with respect to the longitudinal axis X of the device. Thus, the elastic tabs 208 and 209 are positioned at any location along the length of the track within recesses 201 and 211 that define the track. Therefore, during the manufacturing process, the manufacturer is free to select the longitudinal position of the insert 204 within the aperture 203. It will be noted that the first insert 204 has an end face 214, which, when the first insert 204 is in place, the end face 214, in conjunction with the side wall of the aperture, defines a limited-sized viewing window 207 through which a drug container (not shown) can be observed.

[0066] Device manufacturers can choose to use a single insert 204 on its own or a single end insert 204 in combination with one or more intermediate inserts, such as 205 and 206. In this way, a wide range of viewing window sizes can be achieved depending on the requirements of the drug container to be used. For example, if a large drug container viewing window is required, the manufacturer can choose to use a single insert 204. Conversely, if a smaller drug container viewing window is desired, the manufacturer can choose to use a single end insert 204 in combination with several intermediate inserts 205 and 206 to significantly reduce the size of the viewing window 207. The intermediate inserts 205 and 206, as well as the end insert 204, can be standardized in size. This makes it possible to increase the efficiency of manufacturing a large number of devices that require viewing windows of different sizes. By using standardized inserts, it becomes necessary to manufacture only one type of intermediate insert 205 and 206, with 205 and 206 being identical, along with one type of end insert 204. Therefore, by changing the number of intermediate inserts, viewing windows of different sizes can be easily obtained at low cost.

[0067] To prevent longitudinal movement of the insert after insertion, connecting elements and corresponding connecting elements are provided. These are shown in Figures 2A and 2C. In Figure 2C, the top cover of insert 204 is exposed to reveal a connecting element 215, which is a T-shaped recess at the distal end of the insert. A corresponding T-shaped connector 216 is fitted into this recess. The same T-shaped connectors are also provided at the proximal end of each intermediate insert, shown as components 216 and 217 in Figure 2A, and at the distal end of the aperture, shown as component 218 in Figure 2A. Each intermediate insert 205 and 206 is provided with a corresponding T-shaped recess (not shown). As shown, the intermediate inserts 205 and 206 do not directly engage with the recesses 210 and 211 that define the tracks, but are held within the aperture by the end insert 204. Alternatively, the intermediate inserts 205 and 206 may include elastic tabs that can engage with tracks provided by the two recesses 210 and 211. As will become clear, coupling the T-connector with the tracks and their corresponding elastic tabs means that the inserts and intermediate inserts may be pushed into place from a direction substantially perpendicular to the longitudinal axis X of the device. Once in place, the T-connector prevents the inserts from moving in the longitudinal direction.

[0068] In the exemplary embodiments described above, a T-shaped connector and a corresponding T-shaped recess are used, but it will be understood that other types of connectors may be used to prevent the longitudinal movement of the insert. For example, an L-shaped connector and a corresponding L-shaped recess may be used. Alternatively, hooks may be provided at the distal end of the aperture and the proximal end of the intermediate insert, and a corresponding hole or loop for receiving the hooks may be provided at the distal end of the insert.

[0069] In other alternative embodiments, the connecting elements and corresponding connecting elements are configured such that the insert is mounted on the track and then slides longitudinally for the coupling to be performed. For example, a barbed element may be provided at the distal end of an aperture in which an insert having a corresponding receiving cavity can slide. The barb is located on the opposing surface when it enters the cavity, thereby preventing pull-out. Alternatively, the barbed element may be mounted on the insert, with the corresponding receiving cavity located at the distal end of the aperture.

[0070] Figure 3 shows a third exemplary embodiment. This example also provides a device 301 which includes a body 302 that forms the outer case of the device. The body includes an aperture 303. The aperture 303 defines a viewing window that allows a drug container (not shown) to be seen when it is in a predetermined position within the body of the device. The drug container is placed within the body 302 in the same manner as described with respect to the first exemplary embodiment.

[0071] Alternative inserts 304 and 305 are provided that fit into aperture 303. The inserts include apertures 306 and 307 of different dimensions. When in place, the inserts reduce the size of the viewing window 303 to a larger or smaller degree, depending on the dimensions of apertures 306 and 307. Once inserted, the dimensions of the viewing window are defined overall by the dimensions of apertures 306 and 307. Since the external dimensions of inserts 304 and 305 are identical, different inserts can be selected for use with the same outer casing 302. Again, the inserts include elastic tabs 308 and 309. The elastic tabs 308 and 309 engage with corresponding recesses in the body of the device, for example, 310, thereby securing the inserts in place. The inserts and corresponding recesses may be as described with respect to either of the two exemplary embodiments described above.

[0072] Figures 4A and 4B show a fourth embodiment of the present invention. In this embodiment, the device includes an outer case 402 and a body 403 that forms an inner carrier. The inner carrier is repositionable within the outer case. The inner carrier includes an aperture 404. The inner carrier is configured to house and support a drug container, such as a syringe, so that the drug container is visible through a viewing window defined by the aperture 404. If the drug container is a syringe, typically the portion of the syringe cylinder near the outlet port can be seen through the viewing window.

[0073] The inner carrier further includes several removable segments 405, 406, and 407 that can be removed to extend the dimensions of the aperture. In Figure 4B, the removable segments are illustrated in place on the carrier, while in Figure 4A, two segments 405 and 406 have been removed. The segments are connected to each other and joined to the rest of the carrier by a breakable element such as thin-walled plastic 408. Thus, the device manufacturer can extend the aperture 404 to a desired length by simply breaking off the desired number of removable segments, thereby creating the extended aperture 409.

[0074] Other destructible elements can also be used. For example, a breakable plastic strand can be used to connect the detachable segment to the inner carrier. Alternatively, the detachable segment may be attached to the inner carrier using an adhesive with sufficiently low tackiness, and the joint can be broken without damaging the inner carrier.

[0075] It is also conceivable that an unbreakable element may be used to secure the detachable segment to the inner carrier. For example, the detachable segment may be secured by a releasable fastener, or by a positioning peg that engages within a corresponding hole or cavity of the detachable segment.

[0076] After removing the required number of segments, the inner carrier 403 is placed inside the outer case 402. As shown in the drawing, the outer case 402 includes a second aperture defined by a side wall 411. The apertures of the inner and outer carriers coincide, thereby defining a viewing window 410 through which the amount of drug in the drug container can be seen when the drug container is present. As shown in the lower diagram of Figure 4A, the terminal detachable segment 407 remains in place, so when the inner carrier is inserted, the dimensions of the viewing window 410 are defined partly by the side wall 411 of the second aperture of the outer case and partly by the dimensions of the extended inner aperture 409 of the inner carrier.

[0077] The second aperture of the outer case 402 is elongated, and the tangential width of this second aperture is less than the tangential width of the detachable segment, thus preventing the removal of any remaining detachable segments of the inner carrier after insertion of the inner carrier. This prevents the end user from interfering with the size of the viewing window.

[0078] As disclosed in connection with any of the embodiments described above, the body, one or more inserts, one or more detachable segments, inner carrier and / or outer case are typically formed from plastic, for example, by molding.

[0079] A drug container, such as those used in connection with any embodiment described herein, may be a sealed cartridge, such as a glass vial sealed with a film, configured to break when the device is operated. Alternatively, the drug container may be a syringe, in which the drug is contained within a hollow cylinder, typically formed from glass or clear plastic. The drug is sealed to the environment by a piston that can move within the cylinder. The piston is connected to a piston rod that actsuates the piston. The syringe further includes an outlet port, located distal to the piston, which is in fluid communication with the inside of the cylinder. Typically, the outlet port is sealed, for example, with a film, until use. The seal of the outlet port is broken when the device is operated. Alternatively, a needle may be fluidly connected to the outlet port, and the needle may be capped until use to maintain the drug in a sterile state.

[0080] Typically, a tubular delivery component, such as a needle or cannula, is provided to deliver liquid medication from a drug container to a patient. In the embodiments described above, the tubular delivery component is attachable to the proximal end of the device. The tubular delivery device is configured to puncture the seal of the drug container upon activation or attachment. For example, the tubular delivery device may include a double-ended needle. One end of the double-ended needle is used to puncture the patient's skin, and the other end is used to puncture the seal of the drug container.

[0081] The liquid drug administration devices described herein are typically liquid drug injection devices. Typically, the device is configured to inject a drug into a patient. For example, delivery can be subcutaneous, intramuscular, or intravenous. Such devices are operated by the patient or by a caregiver such as a nurse or physician. Such devices include various types of safety syringes, pen injectors, or autoinjectors. The device may include a cartridge-based system in which the sealed ampoule needs to be punctured before use. The amount of drug delivered using these various devices can range from about 0.1 ml to about 2 ml, more commonly from about 0.5 ml to about 1 ml. Further devices may include high-volume devices ("LVDs") or patch pumps configured to adhere to the patient's skin for a certain period (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver "large" volumes of drug (typically about 2 ml to about 10 ml).

[0082] When combined with specific medications, the aforementioned devices are also customized to operate within the required specifications. For example, a device may be customized to inject the medication within a certain time frame (e.g., approximately 3 to 20 seconds for auto-injectors, or approximately 10 to 60 minutes for LVDs). Other specifications include shelf life, expiration date, biocompatibility, and environmental considerations, as well as several conditions related to low or minimal discomfort or human factors. Such differences can arise from various factors, such as the viscosity of the medication (e.g., approximately 3 cP to 50 cP). As a result, drug delivery devices often include hollow needles of approximately 25 to 31 gauge. Common sizes are 27 and 29 gauge.

[0083] The drug delivery devices described herein may also include one or more automated functions. For example, one or more needle insertions, drug injections, and needle retractions may be automated. Energy for one or more automated stages may be supplied by one or more energy sources. Energy sources may include, for example, mechanical energy, pneumatic energy, chemical energy, or electrical energy. For example, a mechanical energy source may include springs, levers, elastomers, or other mechanical mechanisms for storing or releasing energy. One or more energy sources may be integrated into a single device. The device may further include gears, valves, or other mechanisms for converting energy into the movement of one or more components of the device.

[0084] Each of the automated functions of an automatic syringe is activated via an activation mechanism. Such an activation mechanism may include one or more buttons, levers, needle sleeves, or other activation components. Activating an automated function can be a one-step or multi-step procedure; that is, the user may need to activate one or more activation components to perform the automated function. For example, in a one-step procedure, the user can place the needle sleeve against their body and press it down to inject the medication. Other devices may require a multi-step activation of the automated function; for example, the user may need to press down a button and retract the needle sleeve to inject the medication.

[0085] In addition, the activation of one automated function can trigger one or more subsequent automated functions, thereby forming an activation sequence. For example, the activation of a first automated function may trigger at least two needle insertions, drug injections, and needle retractions. Some devices may also require a specific set of steps to perform one or more automated functions. Other devices may operate through a set of independent steps.

[0086] Some delivery devices may include one or more functions of a safety syringe, a pen injector, or an autoinjector. For example, a delivery device may include a mechanical energy source (typically found in autoinjectors) configured to automatically inject the drug, and a dose setting mechanism (typically found in pen injectors).

[0087] If the device of this disclosure includes an energy source and / or a starting component, such an energy source and / or a starting component is typically located inside the device or at its distal end.

[0088] Typically, the drug is a liquid drug. Alternatively, the drug can be a reconstituted drug suitable for forming a liquid drug. The liquid drug can be a solution or suspension formulation. Generally, liquid drugs are suitable for injection.

[0089] As used interchangeably in this specification, the terms “drug” or “pharmaceutical” mean a pharmaceutical preparation comprising at least one pharmaceutically active ingredient.

[0090] The term “drug delivery device” should be understood to encompass any type of device, system, or apparatus configured to deliver a drug directly into the body of a human or animal (the best application is expressly intended by this disclosure). “Immediate delivery” means that no intermediate handling of the drug by the user is required between the discharge of the drug from the drug delivery device and its delivery into the body of a human or animal. Typical examples of drug delivery devices, without limitation, are found in injection devices, inhalers, and supply systems for the gastrointestinal tract. Exemplary injection devices, also without limitation, include, for example, syringes, auto-injectors, injection pen devices, and spinal injection systems.

[0091] Modifications (additions and / or deletions) of various components of the substances, formulations, apparatus, methods, systems, and embodiments described herein can be made without departing from the full scope and spirit of the invention, and it will be understood by those skilled in the art that the invention encompasses all such modifications and all equivalents of the invention.

[0092] As used herein, the terms “drug” or “agent” are used herein to describe one or more pharmaceutically active compounds. As described below, a drug or agent may include at least one small or large molecule, or a combination thereof, of various types of formulations for treating one or more diseases. Exemplary pharmaceutically active compounds may include small molecules; polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more of these drugs are also contemplated.

[0093] The term “drug delivery device” encompasses all types of devices or systems configured to administer drugs into the body of a human or animal. Without limiting itself, drug delivery devices may include injection devices (e.g., syringes, pen injectors, autoinjectors, high-volume devices, pumps, perfusion systems, or other devices configured for intraocular, subcutaneous, intramuscular, or intravascular delivery), skin patches (e.g., osmotic, chemical, or microneedles), inhalers (e.g., nasal or pulmonary), implants (e.g., coated stents, capsules), or delivery systems for the gastrointestinal tract. The drugs described herein may be particularly useful in injection devices, including needles, such as small-gauge needles.

[0094] A drug or pharmaceutical can be contained within a main package or “drug container” applied for use with a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other container configured to provide a chamber suitable for the storage (e.g., short-term or long-term storage) of one or more pharmaceutically active compounds. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage can be carried out at room temperature (e.g., about 20°C) or refrigerated temperature (e.g., from about -4°C to about 4°C). In some cases, the drug container can be, or may include, a dual-chamber cartridge configured to store two or more components of a drug formulation (e.g., a drug and a diluent, or two different types of drugs) separately, one in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing between two or more components of the drug or pharmaceutical before and / or during administration into the body of a human or animal. For example, two chambers may be configured to be fluidly connected to each other (e.g., by a conduit between the two chambers) and, if desired, allow the user to mix the two components before administration. Alternatively, or in addition to this, the two chambers may be configured to allow the components to be mixed when they are being administered into the body of a human or animal.

[0095] The drug delivery devices and drugs described herein can be used to treat and / or prevent a number of different types of disorders. Exemplary disorders include, for example, diabetes mellitus or complications associated with diabetes such as diabetic retinopathy, and thromboembolic disorders such as deep vein thromboembolism or pulmonary thromboembolism. Further exemplary disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis.

[0096] Exemplary drugs for the treatment and / or prevention of diabetes or complications associated with diabetes include insulin, e.g., human insulin, or human insulin analogs or derivatives; glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or their analogs or derivatives; dipeptidyl peptidase-4 (DPP4) inhibitors; or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the term “derivative” means any substance that is structurally similar enough to the original substance that it can thereby have similar function or activity (e.g., therapeutic effect).

[0097] Exemplary insulin analogs include Gly(A21),Arg(B31),Arg(B32) human insulin (insulin glargine); Lys(B3),Glu(B29) human insulin; Lys(B28),Pro(B29) human insulin; Asp(B28) human insulin; human insulin in which proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0098] Exemplary insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29Ly These are sB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-(N-litocoryl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin; and B29-N-(ω-carboxyheptadecanoyl) human insulin.Exemplary GLP-1, GLP-1 analogues, and GLP-1 receptor agonists include, for example: Lixisenatide / AVE0010 / ZP10 / Lyxumia, Exenatide / Exendin-4 / Byetta / Bydureon / ITCA650 / AC-2993 (a 39-amino acid peptide produced by the salivary glands of the Gila monster), Liraglutide / Victoza, Semaglutide, Taspoglutide, Syncria / Albiglutide, and Dulaglutide. glutide), r-Exendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX These include -096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN, and Glucagon-XTEN.

[0099] An example oligonucleotide is mipomersen / kynamro, a cholesterol-lowering antisense drug for the treatment of familial hypercholesterolemia.

[0100] Exemplary DPP4 inhibitors include vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0101] Exemplary hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, choliongonadotropin, menotropin), somatropins (somatropin), desmopressin, terlipressin, gonadrelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0102] Exemplary polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or very low molecular weight heparin, or their derivatives, or sulfated forms of the above-mentioned polysaccharides, such as polysulfated forms, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include HylanG-F20 / Synvisc and sodium hyaluronate.

[0103] As used herein, the term “antibody” refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal, monoclonal, recombinant, chimeric, non-immune or humanized, fully human, non-human (e.g., mouse), or single-chain antibodies. In some embodiments, antibodies may have effector function and may be able to immobilize complement. In some embodiments, antibodies may have a low ability to bind to or be unable to bind to Fc receptors. For example, an antibody may be an isotype or subtype, an antibody fragment or a variant that does not support binding to Fc receptors, for example, having a mutated or deleted Fc receptor-binding region.

[0104] The term “fragment” or “antibody fragment” refers to a polypeptide derived from an antibody polypeptide molecule (e.g., antibody heavy and / or light chain polypeptide) that does not contain the full-length antibody polypeptide but still contains at least a portion of a full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may include cleaved portions of full-length antibody polypeptides, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, monospecific or multispecific antibody fragments such as Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, bispecific, tripspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), minibodies, chelated recombinant antibodies, tribodies or vibodies, intrabodies, nanobodies, small modular immunoassays (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Further examples of antigen-binding antibody fragments are known in the art.

[0105] The term “complementarity-determining region” or “CDR” refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term “framework region” refers not to the CDR sequence itself, but to the amino acid sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for maintaining the correct positioning of the CDR sequence and enabling antigen binding. While the framework region itself is not typically directly involved in antigen binding, as is commonly known in the art, specific residues within the framework region of a particular antibody may be directly involved in antigen binding, or one or more amino acids within the CDR may influence the ability to interact with the antigen.

[0106] Exemplary antibodies include anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0107] The compounds described herein can be used in pharmaceutical formulations comprising (a) a compound or a pharmaceutically acceptable salt thereof, and (b) a pharmaceutically acceptable carrier. The compounds can also be used in pharmaceutical formulations comprising one or more other pharmaceutical active ingredients, or in pharmaceutical formulations in which the compound or its pharmaceutically acceptable salt present is the sole active ingredient. Thus, the pharmaceutical formulations of the present disclosure include any formulation made by mixing the compounds described herein and a pharmaceutically acceptable carrier.

[0108] Pharmaceutically acceptable salts of any of the drugs described herein are also contemplated for use in drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts. Acid addition salts include, for example, HCl or HBr salts. Basic salts include, for example, alkali or alkaline earth metals, such as Na + , or K + [[ID=!0]], or Ca 2+ , or ammonium ion N + (R 1 )(R 2 )(R 3 )(R 4 )(wherein R 1 to R 4 are each independently of the others: hydrogen, optionally substituted C1-C6-alkyl group, optionally substituted C2-C6-alkenyl group, optionally substituted C6-C 10 -aryl group, or optionally substituted C6-C 10 -heteroaryl group), and salts having cations selected therefrom. Further examples of pharmaceutically acceptable salts are known to those skilled in the art.

[0109] Pharmaceutically acceptable solvates are, for example, hydrates or alkanolates such as methanolate or ethanolate.

[0110] Modifications (additions and / or deletions) of various components of the substances, formulations, apparatus, methods, systems, and embodiments described herein can be made without departing from the full scope and spirit of the invention, and it will be understood by those skilled in the art that the invention encompasses all such modifications and all equivalents of the invention.

Claims

1. A system comprising a liquid drug delivery device and one or more pre-forming elements, The liquid drug dispensing device includes a body configured to house and support a drug container; The device includes a proximal end and a distal end, and its longitudinal axis extends from the proximal end to the distal end; The drug container contains the initial amount of the drug, The body includes an aperture; The aperture is elongated and positioned parallel to the longitudinal axis of the device; The aperture includes a viewing window that aligns with the drug container when the drug container is present; The size of the viewing window can be adjusted by one or more pre-formed elements; One or more walls defining the drug container are transparent, and at least one transparent wall is aligned with the viewing window when the drug container is inside the device, so that the inside of the drug container can be seen through the viewing window when the drug container is inside the device; The system is configured such that the size of the viewing window can be adjusted in relation to the initial amount of drug in the drug container to conceal the empty portion of the drug container when the drug container is housed and supported by the main body. The aforementioned system.

2. The system according to claim 1, wherein one or more pre-forming elements include one or more inserts, and the aperture is configured to receive one or more inserts, and the one or more inserts partially obscure the aperture to reduce the size of the viewing window when they are present.

3. One or more inserts define one or more sidewalls of the aperture. The system according to claim 2, comprising one or more elastic tabs that engage in one or more corresponding recesses located in

4. The system according to claim 3, wherein the aperture includes a first side wall and a second side wall, each of the first and second side walls extending in a direction substantially parallel to the longitudinal axis of the device, the first side wall includes a first recess for engaging with a first elastic tab, the second side wall includes a second recess for engaging with a second elastic tab, and the first insert includes both the first and second elastic tabs.

5. The system according to claim 4, wherein the longitudinal length of at least one recess in one side wall substantially corresponds to the length of the corresponding elastic tab that engages with the recess so that the insert attached to the elastic tab does not move longitudinally.

6. The system according to claim 4, wherein the first and second recesses together form tracks that extend substantially longitudinally with respect to the longitudinal axis of the device, the first and second elastic tabs of the first insert can engage with the tracks at any position along their length, and the first insert further includes a connecting element applied to engage with a corresponding connecting element at the end of the aperture, optionally via one or more intermediate inserts, so as to prevent the first insert from moving longitudinally.

7. The system according to claim 6, wherein the aperture is configured to receive one or more intermediate inserts, each intermediate insert comprising a connecting element substantially identical to the connecting element of a first insert and a corresponding connecting element substantially identical to the corresponding connecting element at the end of the aperture.

8. The system according to any one of claims 2 to 7, wherein one of the inserts includes an aperture that defines only the dimensions of a size-adjustable viewing window.

9. The system according to any one of claims 2 to 8, wherein the aperture has received one or more inserts.

10. The system according to any one of claims 1 to 9, wherein the main body forms the outer case of the device.

11. The system according to claim 1, wherein one or more pre-forming elements include one or more removable segments, and the body includes one or more removable segments adjacent to the aperture, the removable segments being configured to extend the aperture by removal in order to increase the size of the viewing window.

12. The system according to claim 10, wherein the detachable segment is attached to the main body by a breakable element, and the breakable element allows the detachable segment to be broken off or punched out.

13. The system according to claim 11 or 12, wherein the main body forms an inner carrier within an outer case, the outer case includes a second aperture, and both the aperture of the main body and the second aperture of the outer case include a viewing window.

14. The system according to any one of claims 1 to 13, wherein the device includes a drug container.

15. The system according to any one of claims 1 to 14, wherein the drug container is a syringe.

16. A method for manufacturing a liquid drug delivery device, comprising: A liquid drug administration device comprising a body configured to house and support a drug container, wherein the device comprises a proximal end and a distal end, its longitudinal axis extending from the proximal end to the distal end, the body comprises an aperture, the aperture is elongated and positioned parallel to the longitudinal axis of the device, the aperture comprises a viewing window that aligns with the drug container when the drug container is present, the drug container comprises an initial amount of drug, and one or more walls defining the drug container are transparent, and at least one transparent wall aligns with the viewing window when the drug container is present, so that the inside of the drug container can be seen through the viewing window when the drug container is present in the device; One or more pre-forming elements are used to adjust the size of the viewing window in relation to the initial amount of drug in the drug container, so as to conceal the empty portion of the drug container when the drug container is housed and supported by the main body. The method, including the method described above.

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