Packaging Assembly

Abstract

The packaging assembly includes: a case configured to at least partially house a plurality of injection devices for delivering medication and shaped as a box having at least one open end; a lid connected to the case and movable between an open position and a closed position, configured to be hinged to one other surface at an edge of the lid farthest from the open end surface of the case, and arranged to extend substantially across the open end surface of the case in the closed position and at least partially across the one other surface adjacent to the open end surface; and a handle portion having an upper surface and a lower surface and arranged to protrude from the lid, such that pressure applied to the upper surface when the lid is in the closed position moves the lid to the open position, and pressure applied to the lower surface when the lid is in the open position moves the lid to the closed position.

Description

[Technical Field]

[0001] The present application relates to packaging assemblies for medications, and particularly, but not exclusively, to packaging assemblies configured to provide reminder alerts at scheduled dosing times. [Background technology]

[0002] Patients suffering from chronic diseases require regular treatment with medication, for example, based on a predetermined schedule. Certain medications require refrigeration and are often stored in a home refrigeration device or refrigerator. In a home treatment environment, patients store the medication in their own refrigerator and administer the prescribed dose as needed. Therefore, medications are typically provided in secondary packaging so that they can be conveniently placed and stored in a home refrigerator. However, medications must be stored together with other items that require constant refrigeration, such as food and beverages.

[0003] Depending on the dosage form of the drug, the secondary packaging containing the drug may contain the primary packaged drug itself, or it may contain one or more different types of drug delivery devices. For example, the drug may be provided in a pre-filled syringe or pen-type injector.

[0004] Chronic diseases that patients suffer from can cause loss of mobility, strength, and dexterity in the hands and fingers. For example, rheumatoid arthritis is a systemic disease of connective tissue accompanied by inflammation, primarily affecting the joints. Patients with rheumatoid arthritis may experience swelling of the fingers and middle joints of the hand, morning stiffness in the fingers and wrists, and tenderness in the joints behind the fingers or behind the toes when subjected to lateral compression. Patients may also be unable to form a fist or pinch grip, and may also experience reduced strength in the hands and fingers. Summary of the Invention [Means for solving the problem]

[0005] An embodiment of the present disclosure provides a packaging assembly including: a case configured to at least partially house a plurality of injection devices for delivering medicaments, the case configured as a box having at least one open end; a lid connected to the case, movable between an open position and a closed position, configured to be hinged to one other surface at an edge of the lid farthest from the open end of the case, and arranged to extend substantially across the open end of the case in the closed position and at least partially across the one other surface adjacent to the open end; and a handle portion having an upper surface and a lower surface, arranged to protrude from the lid, such that pressure applied to the upper surface moves the lid to the open position when the lid is in the closed position, and pressure applied to the lower surface moves the lid to the closed position when the lid is in the open position.

[0006] The handle portion can be formed to extend longitudinally along the lid, parallel to a boundary formed between a first portion of the lid extending across the open end face of the case and a second portion of the lid extending partially across one other face of the case.

[0007] The packaging assembly may include one or more spring ejectors configured to bias at least one of the plurality of injection devices at least partially out of the case when the lid is in the open position.

[0008] The case can be configured to accommodate a plurality of injection devices in an arrangement where each injection device is positioned perpendicular to the open end face of the case.

[0009] The case may include one spring ejector for each of the plurality of injection devices, each spring ejector configured to bias at least a portion of a corresponding injection device through the open end face of the case.

[0010] The case can be configured to accommodate a plurality of injection devices in an arrangement in which each injection device lies parallel to the open end face of the case.

[0011] The case may include a spring ejector configured to bias the injection devices toward the open end face of the case.

[0012] The packaging assembly may include a retaining lip and a release opening.

[0013] The multiple injection devices are biased against the retaining lip by a spring ejector, and the retaining lip is positioned to retain the multiple injection devices within the case.

[0014] The release slot may be positioned such that the release opening allows one of the multiple injection devices to be lifted above the retaining lip.

[0015] The lid may include a dosing slot configured to accommodate one injection device.

[0016] The spring ejector can be configured to bias the plurality of injection devices toward the lid such that when the lid is moved from the closed position to the open position, one of the plurality of injection devices is received within the dispensing slot.

[0017] The case can be configured to accommodate a plurality of injection devices in an arrangement where each injection device is positioned perpendicular to the open end face of the case.

[0018] The case may include a plurality of flexible bands, each arranged to extend around the end of the corresponding injection device that is farthest from the open end face of the case, such that when the flexible band is pulled tight, the corresponding injection device is urged by the flexible band toward the open end face of the case.

[0019] The packaging assembly can include a plurality of injection devices.

[0020] Each of the plurality of injection devices can include a loop element formed at one end of the injection device, and the case is configured to house the plurality of injection devices in an arrangement in which the loop element of each injection device is adjacent to the open end face of the case.

[0021] Another aspect of the present disclosure provides a packaging assembly that includes a case configured to at least partially house a plurality of injection devices for delivering a medication, the case being formed as a box having at least one opening; and at least one tray configured to house at least one of the plurality of injection devices, the tray being positioned to slide out of the case through the opening.

[0022] The packaging assembly may include one tray for each of the plurality of injection devices.

[0023] Each of the plurality of trays can be configured to rotate about its length such that injection devices contained within the tray fall out of the tray.

[0024] The packaging assembly can include one tray configured to house all of the multiple injection devices.

[0025] The tray may be configured to hinge around an edge of the tray adjacent the case when fully extended from the case.

[0026] The tray can be configured to accommodate a plurality of injection devices in an arrangement with each injection device positioned perpendicular to the direction in which the tray is configured to slide, and a side plate of the tray can include at least one opening for pushing one or more of the injection devices out of the tray.

[0027] The tray can be formed with at least one angled portion arranged to lift one or more of the injection devices from the tray when pushed through the at least one opening in the side panel.

[0028] The tray can be configured to accommodate a plurality of injection devices in an arrangement where each injection device is positioned parallel to the direction in which the tray is configured to slide, and the bottom plate of the tray can include at least one opening for pushing one or more of the injection devices upwardly from the tray.

[0029] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0030] [Figure 1] FIG. 1 is an isometric view of a packaging assembly according to a first exemplary embodiment. [Figure 2] FIG. 2 is an isometric view of the packaging assembly of FIG. 1. [Figure 3] FIG. 2 is an exploded view of the packaging assembly of FIG. 1. [Figure 4] FIG. 1 is a block diagram of an electronic system of a packaging assembly in accordance with an illustrative embodiment. [Figure 5A] FIG. 1 illustrates an isometric view of a packaging assembly in accordance with an exemplary embodiment. [Figure 5B] FIG. 1 illustrates an isometric view of a packaging assembly in accordance with an exemplary embodiment. [Figure 6A] FIG. 1 illustrates an isometric view of a packaging assembly in accordance with an exemplary embodiment. [Figure 6B] FIG. 1 illustrates an isometric view of a packaging assembly in accordance with an exemplary embodiment. [Figure 7A] FIG. 1 illustrates an isometric view of a packaging assembly in accordance with an exemplary embodiment. [Figure 7B] FIG. 1 illustrates an isometric view of a packaging assembly in accordance with an exemplary embodiment. [Figure 8A] FIG. 1 illustrates an isometric view of a packaging assembly in accordance with an exemplary embodiment. [Figure 8B] FIG. 1 illustrates an isometric view of a packaging assembly in accordance with an exemplary embodiment. [Figure 9A] FIG. 1 illustrates an isometric view of a packaging assembly in accordance with an exemplary embodiment. [Figure 9B] FIG. 1 illustrates an isometric view of a packaging assembly in accordance with an exemplary embodiment. [Figure 10A] FIG. 1 illustrates an isometric view of a packaging assembly in accordance with an exemplary embodiment. [Figure 10B] FIG. 1 illustrates an isometric view of a packaging assembly in accordance with an exemplary embodiment. [Figure 11A] 1 is a side view of an automatic injection device for use with a packaging assembly according to an exemplary embodiment. [Figure 11B] 1 is a side view of an automatic injection device for use with a packaging assembly according to an exemplary embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0031] An embodiment of the present invention provides a packaging assembly configured to house and store multiple injection devices for delivering medication. The injection devices are an example of a drug delivery device and can be pen injectors or auto-injectors. The packaging assembly is configured to provide access to the multiple injection devices to patients with reduced mobility, strength, and / or dexterity. The packaging assembly can further enable easy removal or insertion of the injection devices by the patient. The packaging assembly provides a predictable, convenient, and independent experience for the patient.

[0032] The packaging assembly can include a lid for safe and discreet storage of the injection devices. The lid can be configured to allow a patient to open the lid and remove multiple injection devices without requiring a fist or pinch grip.

[0033] Drug delivery devices, as described herein, can be configured to inject medication into a patient. For example, delivery can be subcutaneous, intramuscular, or intravenous. Such injection devices can be operated by the patient or a caregiver, such as a nurse or physician, and can include various types of safety syringes, pen injectors, or auto-injectors. Injection devices can include cartridge-based systems that require puncturing a sealed ampoule prior to use. The volume of medication delivered by these various injection devices can range from about 0.2 ml to about 3 ml.

[0034] In combination with a specific drug, the injection devices described herein can also be customized to operate within required specifications. For example, the device can be customized to inject the drug within a specific time period (e.g., about 3 to about 20 seconds for an auto-injector). Other specifications can include low or minimal discomfort levels, or specific conditions related to human factors, such as shelf life, expiration date, biocompatibility, and environmental considerations. Such variations can result from a variety of factors, such as the viscosity of the drug, which ranges from about 3 cP to about 50 cP. Accordingly, injection devices often include hollow needles ranging in size from about 25 to about 31 gauge. Common sizes are 27 and 29 gauge.

[0035] The injection devices described herein may also include one or more automated functions. For example, one or more of needle insertion, medication injection, and needle retraction may be automated. Energy for one or more automated steps may be provided by one or more energy sources. Energy sources may include, for example, mechanical, pneumatic, chemical, or electrical energy. For example, a mechanical energy source may include a spring, lever, elastomer, or other mechanical mechanism for storing or releasing energy. One or more energy sources may also be combined into a single device. The device may further include gears, valves, or other mechanisms for converting energy into movement of one or more components of the device.

[0036] One or more automated functions of an auto-injector can be activated via an activation mechanism. Such an activation mechanism can include one or more of a button, lever, needle sleeve, or other activation member. Activation can be a one-step or multi-step process. That is, a user may be required to activate one or more activation mechanisms to perform an automated function. For example, a user may press a needle sleeve against their body to perform an injection of medication. In other devices, a user may be required to depress a button to retract a needle shield to perform an injection.

[0037] Additionally, such activation can activate one or more mechanisms. For example, an activation sequence can activate at least two of needle insertion, medication injection, and needle retraction. Some devices can also require a specific sequence of steps to perform one or more automated functions. Other devices can operate by sequence-independent steps.

[0038] Some delivery devices can include one or more features of a safety syringe, a pen injector, or an auto-injector. For example, a delivery device can include a mechanical energy source (typically found in an auto-injector) and a dose setting mechanism (typically found in a pen injector) configured to automatically inject the medication.

[0039] 1 and 2, a packaging assembly 100 according to an exemplary embodiment is shown. The packaging assembly 100 includes a case 110 having a lid 120. The case 110 includes a bottom surface 131, a top surface 141, and two side walls 142. The bottom surface 131 curves to meet the top surface 141 at the rear of the device. At the front end of the case 110, an opening is formed between the bottom surface 131, the top surface 141, and the two side walls 142.

[0040] The lid 120 of the case 110 is positioned to cover the opening of the case 110. The lid 120 is hingedly attached between the two side walls 142 of the case 110. The lid 120 is hingedly movable between a closed position and an open position. In the closed position, the lid 120 is positioned to cover the opening of the case 110. In the open position, the opening of the case 110 is exposed, allowing access to the interior of the case 110.

[0041] As shown in FIG. 1 , the bottom surface 131 of the case 110 is shorter than the top surface 141. The lid 120 extends from the front edge of the bottom surface 131 to the front edge of the top surface 141. The lid 120 completely covers the front surface of the packaging assembly 100 and covers a portion of the underside of the packaging assembly 100. The lid 120 may be curved. This curvature allows the lid 120 to form the entire front and a portion of the bottom of the case 110 in the closed position. Other lid configurations are contemplated.

[0042] The lid 120 may include a latching mechanism for holding the lid 120 in a closed position. The latching mechanism may include a protruding member disposed on an edge of the lid 120. The protruding member may be configured to engage a corresponding feature in the case 110 when the lid is in the closed position. The protruding member may be flexible or retractable so as to disengage from the case 110 and allow the lid 120 to move to the open position.

[0043] The lid 120 further includes a handle 121. The handle 121 is formed to protrude from the outer surface of the lid 120. The handle 121 protrudes from the front surface of the case 110 when the lid 120 is in the closed position. The handle 121 is formed to extend laterally along the width of the case 110, parallel to the top surface 141 and the bottom surface 131. The handle 121 is formed to extend across at least a portion of the width of the case 110, and can be formed to extend across the entire width between the two side walls 142.

[0044] The case 110 is configured to hold and store multiple injection devices 10. The depth of the case 110, measured between the rear and the lid 120, is sufficient to accommodate the length of each of the injection devices 10. The depth of the case 110 can be 160 mm to 180 mm. The height of the case 110, measured between the bottom surface 131 and the top surface 141, is sufficient to accommodate the width of each of the injection devices 10. The height of the case can be 30 mm to 40 mm. The width of the case 110, measured between the two side walls 142, is sufficient to accommodate six injection devices 10. The width of the case can be 180 mm to 200 mm. In some examples, the case can be 188.7 mm wide, 174.7 mm high, and 34 mm deep.

[0045] The length of the top surface 141 may be the entire depth of the case 110. The length of the top surface 141 may be 160 mm to 180 mm. The length of the bottom surface 131 may be smaller than the entire depth of the case 110. The length of the bottom surface 131 may be 130 mm to 150 mm. The depth of the overhang of the top surface 141 beyond the front surface of the bottom surface 131 may be 30 mm to 40 mm. Depending on the depth of the overhang, a portion of the length of each injection device 10 may be exposed.

[0046] The bottom surface 131, the top surface 141, and the two side walls 142 are formed from an opaque material, such as an opaque plastic material. The lid 120 is formed from a translucent or matte material, such as a transparent plastic material with a matte coating or treated surface. A portion of the lid 120 can be transparent and translucent to form an observation window through the lid 120.

[0047] The case 110 further includes an internal structure 150 disposed within the opening. The internal structure 150 is visible only when the lid 120 of the case 110 is in the open position. When the lid 120 is in the closed position, the lid obscures the internal structure 150 from view. The internal structure 150 includes a plurality of openings 151. The openings 151 are configured to hold a corresponding plurality of injection devices 10. The internal structure 150 includes a row of six openings 151 for holding six injection devices 10 arranged in a row along the width of the case 110. The injection devices 10 are held in a longitudinal arrangement extending along the depth of the case 110. The packaging assembly 100 can also be configured to hold more than seven or fewer than five injection devices 10 within the case 110.

[0048] The openings 151 have a generally rectangular profile. The openings 151 may also be square or circular in shape to accommodate injection devices 10 of other sizes. The width of each opening is sufficient to accommodate the width of each injection device 10. Each opening 151 opens to an internal space (not shown) for holding an injection device 10. The internal structure 150 is formed such that each opening 151 exposes a portion of the injection device held therein. The openings 151 are formed to expose an end of each injection device 10 at the underside of the case 110.

[0049] When in the closed position, the lid 120 can be configured to hold multiple injection devices 10 in place within the case 110. The lid 120 can be placed in the closed position to prevent the injection devices 10 from falling or sliding out of the case 110. Each injection device 10 can be held in place within a corresponding opening 151 by a friction fit with the opening 151.

[0050] A retention mechanism may hold multiple injection devices 10 in place within the openings 151. The retention mechanism may include a mechanical catch, for example a spring-loaded push-catch push-release mechanism, configured to engage each injection device 10. The injection device 10 is pushed into the opening 151 and presses against the spring of the retention mechanism, engaging the catch. When the injection device 10 is pushed a second time, it releases the catch. A release button or switch may be provided for each of the openings 151, configured to release the catch of the retention mechanism when pressed.

[0051] The ejection mechanism may be configured to push one or more of the injection devices 10 out of the case 110. The ejection mechanism may include one or more springs arranged to push each injection device 10 out of the case 110. Alternatively, a flexible band may be provided for each injection device 10 for withdrawing the injection device from the case 110. The ejection mechanism is described in more detail below with respect to Figures 5 and 6.

[0052] FIG. 2 shows the packaging assembly 100 with the lid 120 in the closed position. The handle 121 extends laterally along the width of the case 110. The handle 121 extends across a portion of the width of the case 110 that is less than the entire width of the case 110. The width of the handle 121 can be between 80 mm and 110 mm. The handle 121 protrudes from the front of the case 110 when the lid 120 is in the closed position. The depth of the handle 121 can be between 5 mm and 20 mm. The thickness of the handle 121 can be between 2 mm and 10 mm. The handle 121 can be formed to extend at an angle below horizontal when the lid 120 is in the closed position. The handle 121 can be tilted at an angle between 10° and 20° when the lid 120 is in the closed position.

[0053] The handle 121 is formed to have an upper surface and a lower surface. The handle 121 is configured to move the lid 120 between an open position and a closed position upon application of pressure. When the lid 120 is in the closed position, downward pressure applied to the upper surface moves the lid to the open position. When the lid 120 is in the open position, upward pressure applied to the lower surface moves the lid to the closed position. In this case, the interior of the case 110 can be accessed and closed by simply applying direct pressure without requiring a pinch grip or other fine motor skills.

[0054] The user may receive the packaging assembly 100 in an empty state. When the user is provided with multiple injection devices 10, these injection devices 10 may be loaded into the packaging assembly 100. The lid 120 is moved to the open position, and each of the injection devices 10 is inserted into a corresponding one of the openings 151. The lid 120 is moved to the closed position. The packaging assembly 100 is placed in a refrigerator until the scheduled administration time.

[0055] For example, dosing times can be scheduled every 14 or 28 days depending on the form of medication provided in the multiple injection device 10. In some embodiments, the period between scheduled dosing times can be between 2 and 60 days depending on the requirements of the medication.

[0056] Packaging assembly 100 can be configured to provide a visual and / or audio reminder to the user when it is time to take a scheduled medication. Packaging assembly 100 can be further configured to determine whether lid 120 is in the open or closed position and can deactivate the reminder when it detects that lid 120 has been moved to the open position. When the reminder is active, the user can press handle 121 to move the lid to the open position, and the reminder will also be deactivated. In this manner, the reminder can be easily deactivated with less input, without requiring fine motor skills, for example, to move a switch or press a button.

[0057] The functionality of the packaging assembly 100 is provided by the following electronics:

[0058] Packaging assembly 100 includes an electronic system 160 (not visible in FIG. 1 but visible in FIG. 3). The electronic system includes multiple components coupled together to provide a specific set of functions, as described below. The components of electronic system 160 are mounted on a printed circuit board (PCB), but may alternatively be interconnected by some other medium.

[0059] An electronic system 160 is attached to the internal structure 150. Some of the electronic components of the electronic system 160 are user interface hardware components that together provide a user interface. The components that provide the user interface are located at one end of a row of openings 151 in the internal structure 150.

[0060] The electronic system 160 is shown schematically in Figure 4. The electronic system 160 includes a processor unit 101. The processor unit 101 is shown in Figure 4. The processor unit 101 controls the operation of the other hardware components of the electronic system 160. The processor unit 101 is configured to control the hardware components that form a user interface. The processor unit 101 is configured to process one or more input signals from at least one input sensor.

[0061] Electronic system 160 includes display 161. Display 161 is an example of an optical transducer. Display 161 includes two seven-segment light-emitting diode (LED) arrays. Display 161 is visible to the user through transparent or translucent lid 120, or in some embodiments, through a transparent observation window in lid 120. Electronic system 160 includes light-emitting diode (LED) 162. LED 162 is an example of an optical transducer. The color of LED 162 is different from the color of the seven-segment LED array in display 161; for example, LED 162 is red and display 161 is blue. Electronic system 160 includes reset button 164. Reset button 164 is an example of an input device. Reset button 164 is a spring-loaded plunger button that can be depressed by a user. Electronic system 160 includes speaker 163 (not shown in this figure). Speaker 163 is an example of an audio transducer.

[0062] 3, there is shown an exploded view of a packaging assembly 100 according to a first embodiment. The case 110 of the packaging assembly 100 includes a first member 130 and a second member 140.

[0063] The first member 130 of the case 110 is formed from a single piece. The first member 130 of the case 110 includes a bottom surface 131 and a rear portion of the packaging assembly 100. A plurality of openings 133 are formed along each side edge of the bottom surface 131 for engaging with the second member 140 of the case 110. Three openings 133 are formed along each edge of the first member 130. The first member 130 further includes a plurality of partitions 134 for holding a plurality of injection devices 10 (not shown in FIG. 2 ) in place within the case 110. Each side of the first member 130 includes a first hinged member 136. Each side of the first member 130 includes a first latching member 137.

[0064] The internal structure 150 is formed from within the first member 130 of the case 110. The internal structure 150 includes a plurality of openings 151. The openings 151 are configured to hold a corresponding plurality of injection devices 10. The internal structure 150 further includes one or more openings 152 for user interface hardware components. The openings 152 are disposed within a flat plate 153 of the internal structure 150. The flat plate 153 is disposed adjacent to the openings 151.

[0065] The second member 140 includes a top surface 141 of the case 110, a first side wall 142a, and a second side wall 142b. The length of the first side wall 142a and the second side wall 142b can be less than the overall depth of the case 110. The length of the first side wall 142a and the second side wall 142b can be 130 mm to 150 mm. The second member 140 is formed from a single piece. The second member 140 further includes a plurality of partitions 144 for holding and storing a plurality of injection devices 10 in position within the case 110. The partitions 144 of the second member 140 are aligned with the partitions 134 of the first member 130.

[0066] The case 110 of the packaging assembly 100 includes a plurality of magnets 148. The magnets 148 are fixed in position on the inner surface of the top surface 141. The case includes four magnets 148 fixed in a square arrangement. The plurality of magnets 148 allows the top surface 141 of the case 110 to be releasably attached to a magnetic surface, for example a steel surface. The magnets 148 may be neodymium magnets.

[0067] The packaging assembly 100 further includes a mounting plate 190. The mounting plate 190 includes a plurality of adhesive strips 191. The mounting plate 190 can be secured to a surface, such as a wall or under a shelf in a refrigerator, using the adhesive strips 191. The mounting plate 190 is formed from a magnetic material, such as steel. The case 110 can be releasably attached to the surface by magnetically adhering to the mounting plate 190.

[0068] The mounting plate 190 includes three adhesive strips 191. The adhesive strips 191 are arranged in parallel across the width of the mounting plate 190, with each adhesive strip 191 extending along substantially the entire length of the mounting plate. Alternatively, the mounting plate 190 can include only two adhesive strips 191 spaced apart on the mounting plate 190, or can include four or more adhesive strips 191 extending in parallel. As a further alternative, the mounting plate 190 can include four adhesive strips 191 located in a rectangular arrangement, for example, at each corner of the mounting plate 190. The mounting plate can include any number of adhesive strips 191 arranged in a regular array.

[0069] The mounting plate 190 can alternatively be placed on top of a shelf without adhesive. The case 110 can be magnetically held under the shelf by magnetic attraction to the mounting plate 190.

[0070] The packaging assembly 100 further includes a plurality of batteries 170. The batteries 170 are positioned to provide power to the user interface components. The second member 140 of the case 110 includes a battery opening 145 formed in the top surface 141. The battery opening 145 is configured to receive the plurality of batteries 170. A battery cover 180 is configured to slidably engage the battery opening 145 of the second member 140 and cover the battery opening 145 when the packaging assembly 100 is in use. The battery cover 180 includes a plurality of latches 181 positioned to engage the second member 140 of the case 110.

[0071] Each of the first side wall 142a and the second side wall 142b of the case 110 includes a plurality of engagement hooks 143. The engagement hooks 143 are disposed on the inner surface of the respective side wall. Each of the side walls 142 includes three engagement hooks 143. Each of the engagement hooks 143 is configured to engage with a corresponding opening 133 in the first member 130 of the case 110.

[0072] The lid 120 of the case 110 includes a second hinge link 126 configured to engage with the first hinge link 136 of the first member 130 of the case 110. The first hinge link 136 and the second hinge link 126 together form a hinge 106 for attaching the lid 120 to the first member 130 of the case 110. For example, the second hinge link 126 includes an opening, and the first hinge link 136 includes a protrusion positioned to fit within the opening of the second hinge link 126. The first hinge link 136 is configured to rotate within the opening of the second hinge link 126.

[0073] The lid 120 of the case 110 includes a second latch member (not shown) configured to engage with the first latch member 137 of the first member 130 of the case 110. The second latch member is configured to releasably engage with the first latch member 137 to maintain the lid 120 in the closed position. For example, the first latch member 137 includes a protrusion, and the second latch member includes an opening configured to releasably engage with the protrusion of the first latch member 137.

[0074] The lid 120 is formed from a translucent plastic material. A portion of the lid 120 may be clear and translucent to form an observation window through the lid 120. A handle 121 is formed as part of the lid 120 and extends outward from the body of the case 110.

[0075] Packaging assembly 100 includes electronic system 160. Electronic system 160 includes the hardware components of a user interface: a display 161, an LED 162, a speaker 163, and a reset button 164. User interface display 161 is visible through translucent lid 120. Electronic system 160 is coupled to battery contacts 169. Battery contacts 169 are attached to a number of batteries 170 to power electronic system 160.

[0076] The electronic system 160 includes a reset switch 165. The reset button 164 is a spring-loaded plunger button arranged to be pressed by a user. The reset switch 165 is a mechanical switch mounted on the electronic system 160. The reset switch 165 is located below the reset button 164. The reset switch 165 is arranged to be activated by the reset button 164. The reset button 164 can be coupled to the reset switch 165.

[0077] The electronic system 160 includes a hinge switch 167. The hinge switch may be an electromechanical switch, such as a microswitch or other small snap-action switch. The hinge switch is an example of a lid-open sensor.

[0078] The hinge switch is positioned to engage the lid 120 of the case 110 when the lid 120 is in the closed position. An actuating member of the lid 120 can be shaped to depress the hinge switch 167 when the lid 120 is in the closed position. The hinge switch can be attached to an edge of the PCB of the electronic system 160. The actuating member of the lid 120 can be positioned to pass over an edge of the PCB of the electronic system 160 when the lid 120 is in the closed position.

[0079] Electronic system 160 further includes a processor unit 101 (not shown in this figure), which is configured to process input signals from one or more sensors and switches on electronic system 160. Processor unit 101 is configured to control the output of user interface elements on electronic system 160.

[0080] 4, a schematic diagram of an electronic system 160 of the packaging assembly 100 according to the first embodiment is shown. The electronic system 160 includes a processor unit 101. The processor unit 101 and other hardware components may be connected via a system bus (not shown). Each hardware component may be connected to the system bus directly or via an interface. A battery 170 is arranged to provide power to the electronic system 160.

[0081] The processor unit 101 controls the operation of the other hardware components of the electronic system 160. The processor unit 101 can be any type of integrated circuit. The processor unit 101 can be, for example, a general-purpose processor. The processor unit 101 can be a single-core device or a multi-core device. The processor unit 101 can be a central processing unit (CPU) or a general-purpose processing unit (GPU). Alternatively, the processor unit 101 can be a more specialized unit, for example a RISC processor with embedded firmware or programmable hardware. It can include multiple processors. The processor unit 101 can be referred to as a processing means.

[0082] The processor unit 101 has a clock speed of 2 Hz. The clock speed is selected to provide a balance between power usage and availability. A higher clock speed provides improved availability by reducing the time required for the processor unit 101 to respond to an input. However, a higher clock speed increases the power usage of the processor unit 101. The clock speed can be selected from 0.5 to 100 Hz.

[0083] The electronic system 160 includes a working or volatile memory 102. The processor unit 101 can access the volatile memory 102 to process data and can control the storage of data in the memory. The volatile memory 102 can be any type of RAM, for example, static RAM (SRAM), dynamic RAM (DRAM), or flash memory. Multiple volatile memories can also be included, but are not shown in this figure.

[0084] The electronic system 160 includes a non-volatile memory 103. The non-volatile memory 103 stores a set of operating instructions for controlling the normal operation of the processor device 101. The non-volatile memory 103 can be any type of memory, such as a read-only memory (ROM), flash memory, or magnetically driven memory. Other non-volatile memories may also be included, but are not shown in this figure.

[0085] The processor unit 101 operates under the control of operational instructions. The operational instructions may include code (i.e., drivers) related to hardware components of the electronic system 160 and code related to the basic operation of the packaging device. The operational instructions may also cause the invocation of one or more software modules stored in the non-volatile memory 103. Generally, the processor unit 101 executes one or more of the operational instructions permanently or semi-permanently stored in the non-volatile memory 103 and temporarily uses the volatile memory 102 to store data generated during the execution of the operational instructions.

[0086] The processor unit 101, the volatile memory 102, and the non-volatile memory 103 may be provided as separate integrated circuit chips connected by an off-chip bus, or may be provided on a single integrated circuit chip. The processor unit 101, the volatile memory 102, and the non-volatile memory 103 may be provided as a microcontroller.

[0087] Electronic system 160 includes clock 104. Clock 104 may be a clock crystal, for example, a crystal oscillator. Clock 104 may be a separate component from processor unit 101 configured to provide a clock signal to processor unit 101. Processor unit 101 may be configured to provide a real-time clock based on a signal from clock 104. Alternatively, clock 104 may be a clock crystal provided on a single integrated circuit chip together with processor unit 101.

[0088] The processor device 101 is configured to perform a countdown operation. The countdown operation monitors the number of days remaining until the scheduled dosing time. The countdown operation is set and activated in response to an input from the reset switch 165. The predetermined period for counting down to the next scheduled dosing time is stored in non-volatile memory along with operating instructions for the processor device 101. The processor device 101 records the number of days in the volatile memory 102 and decrements the recorded number of days by one every 24 hours.

[0089] For example, if the predetermined period until the next scheduled dose time is 14 days, the countdown operation will start on the 14th day.

[0090] The electronic system 160 may include a timer duration switch. The timer duration switch may be configured to select a period of time until the next scheduled medication dose. The timer duration switch may be a slide switch having a first position and a second position. The processor device 101 may be configured to set the period for the countdown to the next scheduled medication dose based on the position of the timer duration switch. The processor device 101 may set the period to be 14 days when the slide switch is in the first position. The processor device 101 may set the period to be 28 days when the slide switch is in the second position.

[0091] The position of the timer duration switch may be preset as part of the manufacturing process and may not be adjustable by the user. Alternatively, the timer duration switch may be accessible to the user to set the timer period until the next scheduled dose time. The timer duration switch may be mounted on the top surface of the PCB of the electronic system. The timer duration switch may be accessible through the battery opening 145.

[0092] Every 24 hours, the number of days recorded in the volatile memory 102 is decremented by one. After 13 days, when one day remains until the scheduled dosing time, the processor device 101 can control the electronic system 160 to generate an output to indicate that the scheduled dosing time is approaching. After 14 days, on the day of the scheduled dosing time, the processor device 101 can control the electronic system 160 to generate an output to indicate that the scheduled dosing time has arrived. The hardware components of the electronic system 160 forming the user interface can be controlled to indicate that the scheduled dosing time has arrived.

[0093] On a given day, e.g., the first day, the reduction in the number of days can be provided in less than 24 hours. For example, the reduction in the number of days can be achieved in 20 or 22 hours. This can help prevent the alert time from progressing further and further into the day after multiple resets of the countdown timer. Alternatively, when the number of remaining days recorded in the volatile memory is equal to 1, the processor device 101 can be configured to reduce the time remaining until the next scheduled dosing time. For example, the processor device 101 can be configured to wait 23 hours before reducing the number of days to 0. In this way, the time of the scheduled dosing time will be one hour earlier than the time the reset button 164 was pressed.

[0094] The processor unit 101 may be configured to perform one or more timing operations. The processor unit 101 may start the timing operation at zero and monitor an increasing amount of time. Alternatively, the processor unit 101 may start the timing operation at a predetermined time and count down until the timer expires.

[0095] The processor unit 101 may be configured to verify the state of charge of one or more batteries 170 contained within the packaging assembly 100. The state of charge is determined to be low if it is below a threshold value (which may be incorporated into the design of the packaging arrangement). The state of charge may be determined by measuring the voltage provided by the battery 170, by monitoring energy usage from a fully charged state, or by a combination of these two techniques.

[0096] The electronic system 160 includes a lid open sensor 167 configured to provide a signal to the processor unit 101 when the lid 120 of the case 110 is in the closed position.

[0097] The lid open sensor 167 can be an electromechanical switch, such as a hinge switch, a microswitch, or other small snap-action switch. The lid open sensor 167 can be positioned to mechanically engage the lid 120 when the lid 120 is in the closed position. The actuating member 128 of the lid 120 can be configured to engage the lid open sensor 167 when the lid 120 is in the closed position. The lid open sensor 167 can be a normally open switch having an open state and a closed state. The switch can be operated to move from the open state to the closed state when depressed. The switch can be configured to pass current only in the closed state.

[0098] The lid open sensor 167 can be configured to provide a signal to the processor unit 101 when the switch is depressed to the closed state by the lid 120. The processor unit 101 can be configured to set a variable to indicate whether the lid 120 has been opened.

[0099] The electronic system 160 includes a reset switch 165. The reset switch 165 is configured to provide a signal to the processor device 101 when activated by the reset button 164. The user presses the reset button 164 to indicate that a scheduled dose has been administered and to reset the time period for the next scheduled dose.

[0100] The reset switch 165 may be a mechanical switch mounted on the electronic system 160. The reset switch 165 is arranged to be activated by the reset button 164. The reset switch 165 may be a normally open switch having an open state and a closed state. The reset switch 165 may be operable to move from the open state to the closed state when pressed. The reset switch 165 may be configured to pass current only in the closed state. The reset switch 165 may be configured to provide a signal to the processor device 101 when moved to the closed state.

[0101] The reset button 164 can be coupled to the reset switch 165. The reset switch 165 can be located below the reset button 164. When the reset button 164 is pressed, the reset switch 165 can be moved to a closed state by the reset button 164. The reset switch 165 is configured to provide a signal to the processor device 101 when activated by the reset button 164. The processor device 101 is configured to reset the countdown operation in response to the signal from the reset switch 165. The processor device 101 resets the time remaining until the scheduled dosing time to 14 days. In some embodiments, a user must press and hold the reset button 164 for two seconds to reset the time period for the next scheduled dosing time. The packaging assembly 100 can eliminate short presses of the reset button 164 to reduce the occurrence of false triggering of the reset operation.

[0102] The electronic system 160 includes a user interface display 161. The display 161 may be operated to provide notifications. The display 161 may be operated to provide an indication of the status of the packaging assembly 100. The display 161 is an example of a status indicator. The display 161 may be operated to show information regarding the status of the packaging assembly 100. The display 161 may be operated to show any number between 00 and 99 by illuminating some or all of the LED segments. The display 161 may also show specific letters.

[0103] Electronic system 160 may include display driver 105. Display driver 105 may be provided as a separate integrated circuit chip connected to processor unit 101 by an off-chip bus. Alternatively, display driver 105 may be provided on a single integrated circuit chip together with processor unit 101. Display driver 105 may be a port expander for individually controlling segments of a seven-segment LED display.

[0104] The processor device 101 may operate the display 161 to indicate the number of days remaining until the scheduled medication time. The display 161 may be operated to provide a visual reminder output that the scheduled medication time has arrived. The display 161 may further be operated to provide a visual reminder output that the scheduled medication time is approaching.

[0105] When the countdown operation of the processor device 101 is reset, the countdown operation starts from the 14th day. The display 161 is operated to show the number "14" to indicate that 14 days remain. Each day, the number of days shown by the display 161 is decreased by one. After 13 days, when there is one day left until the scheduled dosing time, the display 161 is operated to show "01". The display 161 is operated to flash or blink to indicate that the scheduled dosing time is approaching. The display 161 is operated to flash by intermittently showing "01".

[0106] Fourteen days later, on the day of the scheduled medication time, display 161 is operated to show "00". Display 161 is operated to flash to indicate that the scheduled medication time has arrived. Display 161 is operated to flash by intermittently showing "00". The flashing cycle of display 161 can be approximately 0.25 seconds to 2 seconds.

[0107] The processor unit 101 may check the state of charge of one or more batteries 170 contained within the packaging assembly 100. If the state of charge is determined to be low, the display 161 may be operated to show a low battery warning.

[0108] The low battery warning shown by the display 161 can be a message including an uppercase L on a first seven-segment array and a lowercase o on a second seven-segment array. That is, the display 161 can show the message "Lo." The low battery warning can be shown intermittently by the display 161 under the control of the processor device 101. The display 161 can be operated to show the low battery warning alternately with the number of days remaining until the scheduled medication time. The cycle at which the display 161 operates intermittently or alternately can be about 0.25 seconds to 2 seconds.

[0109] The electronic system 160 includes a user interface LED 162. The LED 162 may be operated to provide notifications. The LED 162 may be operated to provide an indication of the status of the packaging assembly 100. The LED 162 is an example of a status indicator.

[0110] The processor device 101 may operate the LED 162 to provide a visual reminder that it is time to take the scheduled medication. Fourteen days later, on the day of the scheduled medication time, the LED 162 may be operated to produce an intermittent output light. The LED 162 may be operated to flash or blink red to provide a visual reminder that it is time to take the medication. The flashing period of the LED 162 may be on the order of 0.25 seconds to 2 seconds.

[0111] The electronic system 160 includes a user interface speaker 163. The speaker 163 may be operated to output notification signals. The speaker 163 may be operated to provide an indication of the status of the packaging assembly 100. The speaker 163 is an example of a status indicator.

[0112] The processor device 101 can operate the speaker 163 to provide an audio reminder that it is time to take the scheduled medication. Fourteen days later, on the day of the scheduled medication time, the speaker 163 can be operated to output an audio reminder that it is time to take the scheduled medication. The speaker 163 can be operated to output an intermittent tone. The period of the speaker 163 output can be about 0.25 seconds to 2 seconds.

[0113] The processor device 101 controls the operation of the speaker 163 in response to a signal input by the lid open sensor 167. When the scheduled medication time arrives, the processor device 101 can operate the speaker 163 to output an audio indication that the scheduled medication time has arrived, as described above. When the lid open sensor 167 provides a signal to the processor device 101 to indicate that the lid 120 of the case 110 is open, the processor device 101 controls the speaker 163 to disable the reminder.

[0114] The processor unit 101 can control the operation of the speaker 163 depending on the stored value of the lid flag. When the lid open sensor 167 provides a signal to the processor unit 101 to indicate that the lid 120 is open, the processor unit 101 can set the lid flag to have a value of 1. The processor unit 101 can control the speaker 163 to stop the reminder when the stored value of the lid flag is equal to 1. The processor unit 101 can reset the lid flag to have a value of 0 when the reset button 164 is pressed.

[0115] In this way, the audio reminder output by the speaker 163 is deactivated only when the lid is opened by the user. The speaker 163 is deactivated only when the user opens the lid 120 of the case 110 to remove the injection device 10 for a scheduled dose, thereby improving the packaging assembly 100's compatibility with scheduled dosing regimens.

[0116] 5A and 5B, there is shown a packaging assembly 200 according to a second embodiment. Elements not described below are substantially the same as those of the first embodiment.

[0117] The case 210 of the packaging assembly 200 includes a flat plate 250 that forms the interior structure of the case 210. The flat plate 250 extends across the entire width of the case 210. An opening 251 for the injection device 10 and an opening 252 for the user interface are formed in the flat plate 250.

[0118] 5C, an ejection mechanism 254 according to a second embodiment is shown. The packaging assembly 200 may include one or more ejection mechanisms 254, one ejection mechanism 254 for each injection device 10. The ejection mechanism 254 includes at least one ejection spring 255 arranged to push the injection device 10 out of the case 210.

[0119] The ejection mechanism 254 can be configured to push a portion of each injection device 10 out of the corresponding opening 251. The ejection mechanism 254 can be biased against the holding mechanism so as to push each injection device when released by the holding mechanism. The holding mechanism and the ejection mechanism can be combined into a push-to-engage and push-to-disengage mechanism. The injection device 10 is pushed into the opening 251 and presses against the spring of the holding mechanism, engaging the catch. When the injection device 10 is pushed a second time, it releases the catch and the ejection spring 255 of the ejection mechanism 254 pushes the injection device 10 at least partially out of the case 110. The spring of the holding mechanism and the ejection spring 255 of the ejection mechanism 254 can also be a single spring. The ejection mechanism 254 includes a camming mechanism 256 for adjusting the push-to-engage and push-to-disengage mechanism.

[0120] 6A and 6B, a packaging assembly 300 according to a third embodiment is shown. Elements not described below are substantially the same as those of the first embodiment.

[0121] The case 310 of the packaging assembly 300 includes a flat plate 350 substantially as described with respect to the second embodiment.

[0122] 6C , an ejection mechanism 354 according to a third embodiment is shown. The ejection mechanism 354 includes a flexible band 355 for each of the multiple injection devices 10. Each band 355 is arranged so that pulling the band 355 causes the corresponding injection device 10 to be pulled out of the case 310. A first end of the band 355 is fixed in place within the case 310. A second end of the band 355 is unattached. The second end is threaded through a corresponding opening 151 and remains outside the case 310. A middle portion of the band 355 is threaded through the end of the injection device 10 within the case 310. In this manner, pulling the band 355 causes the injection device 10 to be pulled out of the case 310.

[0123] The width of band 355 is smaller than the width of each opening 151, so that band 355 can pass through opening 351. The width of band 355 is the same or approximately the same as the width of each injection device 10, so that injection device 10 presses band 355 into place when injection device 10 is inserted into case 310.

[0124] The second end of band 355 includes a ring 356 for pulling band 355. The inner diameter of ring 356 is large enough to allow a finger to be placed through ring 356 to pull band 355. In this manner, band 355 can be pulled without forming a pinch grip. The outer diameter of ring 356 can be larger than opening 351, thereby preventing the second end of band 355 from entering case 310. Alternatively, the second end of band 355 can be formed with a hook or T-shaped handle for pulling band 355.

[0125] 7A and 7B, a packaging assembly 400 according to a fourth embodiment is shown. Elements not described below are substantially the same as those of the first embodiment.

[0126] A case 410 includes a flat plate 450 substantially as described with respect to the second embodiment.

[0127] The case 410 includes a number of trays 453 corresponding to the number of injection devices. Each of the trays 453 is configured to hold one of the injection devices 10. The trays 453 are cylindrical and open on one side so that the injection devices 10 can be inserted into the trays 453 from the side. The case 410 includes six trays 453, one corresponding to each of the openings 451. Each of the trays 453 is positioned to slide in and out of the corresponding opening 451. A retaining lip on one end of the tray 453 can prevent the tray 453 from being completely removed from the case 410. The trays 453 can be rotated within the openings to remove the injection devices 10 from the trays 453. A user can rotate the tray 453 until the open side faces downward and the injection devices 10 fall out of the tray 453. The trays 453 can include one or more retaining grooves or rails to maintain the tray in an upward orientation as it slides in and out of the openings 451. The retaining grooves or rails may be configured to allow the tray 453 to rotate after it has been fully extracted from the case 410 .

[0128] The outer end of the tray 453 includes a ring 454 for pulling the tray 453. The inner diameter of the ring 454 is large enough to allow a finger to be placed through the ring 454 to pull the tray 453. In this manner, the tray 453 can be pulled without forming a pinch grip. Alternatively, the outer end of the tray 453 can be formed with a hook or T-shaped handle for pulling the tray 453.

[0129] The retention mechanism can lock one or more of the trays 453 in place when fully inserted into the case 410. According to one embodiment, the case 410 is formed without a lid. Alternatively, multiple trays 453 can be provided in combination with a lid.

[0130] 8A and 8B, a packaging assembly 500 according to a fourth embodiment is shown. Elements not described below are substantially the same as those of the first embodiment.

[0131] The interior structure 550 of the case 510 is formed to have a single opening 551. The opening 551 is generally rectangular. The opening 551 extends across the entire height of the case 510 and across most of the width of the case 510, all the way to the plate that holds the user interface.

[0132] The case 510 includes a tray 553 configured to hold a plurality of injection devices 10. The tray 553 is generally rectangular in shape. The tray 553 includes a base, two side walls, and a rear wall (not shown). The tray 553 is open at the top and front end, so that a plurality of injection devices 10 can be placed in and lifted out of the tray 553. A plurality of partitions are arranged to hold the injection devices 10 in place within the tray 553. The injection devices 10 are held in a longitudinal arrangement extending along the depth of the case 510.

[0133] The tray 553 is configured to slide in and out of the opening 551. A retaining element at the rear end of the tray 553 can prevent the tray 553 from being completely removed from the case 510. The tray 553 can be configured to pivot downwards when completely extracted from the case 510. The tray 553 can pivot downwards by 10° to 20° to present the injection device 10 to the user.

[0134] The base of the tray 553 is formed with a handle 554 at its front end for pulling the tray 553 out of the case 510. The handle 554 may be formed by an opening or, alternatively, by a protrusion for gripping. The base further includes a number of openings 555 corresponding to the number of injection devices 10. The openings 555 are located between partitions at the front end of the base. The diameter of each opening 555 is large enough for a user to insert a finger to lift the injection device 10 from the tray 553. In this way, the injection device 10 can be easily removed from the tray 553 without having to form a pinch grip.

[0135] 9A and 9B, a packaging assembly 600 according to a fourth embodiment is shown. Elements not described below are substantially the same as those of the first embodiment.

[0136] The internal structure 650 of the case 610 is formed to have a single opening 651. The opening 651 is formed so that the injection device 10 can be passed through the opening 651 from the side. The width of the opening 651 is greater than the length of the injection device 10. The height of the opening 651 is greater than the width of the injection device 10. The opening 651 includes a cutout 653 to enable the injection device 10 to be removed through the opening 651.

[0137] The packaging assembly 600 is configured to hold the injection devices 10 in a lateral arrangement extending along the width of the case 610. The ejection mechanism is configured to push the injection devices 10 towards the opening 651. When an injection device 10 is removed through the opening 651, the ejection mechanism pushes the remaining injection devices 10 towards the opening 651. A spring in the ejection mechanism is arranged to push the injection devices 10 towards the opening 651. Alternatively, a flexible band can be provided substantially as described in relation to the third embodiment.

[0138] The opening 651 forms a retaining lip for retaining the injection device 10 within the case 610. The lip is located along the underside of the opening 651. The lip is positioned such that the ejection mechanism presses the leading injection device 10 against the lip. The injection device 10 can be removed from the case 610 by lifting it onto the retaining lip. The cutout 653 is positioned such that a user can press the underside of the injection device 10 to lift it onto the retaining lip. In this way, when a user presses the injection device 10 upward with their fingertips, the ejection mechanism pushes the injection device 10 out of the case 610 and into the user's palm. The injection device 10 can be easily removed from the case 610 without having to clench a fist or form a pinch grip.

[0139] 10A and 10B, a packaging assembly 700 according to a fourth embodiment is shown. Elements not described below are substantially the same as those of the first embodiment.

[0140] The interior structure 750 of the case 710 is formed with a single opening 751. The opening 751 is generally rectangular. The opening 751 extends the entire height of the case 710 and most of the width of the case 710 to a plate 753 that holds the user interface.

[0141] The case 710 includes a tray 753 configured to hold a plurality of injection devices 10. The tray 753 is generally rectangular in shape. The tray 753 includes a base, a front wall, and a rear wall. The tray 753 is configured to slide in and out of the opening 751. A retention element at the rear end of the tray 753 can prevent the tray 753 from being completely removed from the case 710. The front wall of the tray 753 is formed with a handle 754 on its outward-facing surface for pulling the tray 753 out of the case 710. The handle 754 is formed by an opening or cutout in the outward-facing surface and has an overhanging lip or protrusion for gripping.

[0142] The tray 753 is open at the top, so that multiple injection devices 10 can be placed in the tray 753 and lifted out of it. The injection devices 10 are held in a lateral position extending along the width of the case 710. The base is formed with a downward slope from the rear end of the tray to the front end of the tray 753. In this way, multiple injection devices 10 can slide toward the front end of the tray 753. As shown in this figure, when the tray 753 is extracted from the case 710, the injection devices 10 can be pushed out sideways from the tray 753. The injection devices 10 can be pushed out with one hand until they are in the user's opposite hand. In this way, the injection devices 10 can be easily removed from the tray 753 without having to form a pinch grip or a clenched fist.

[0143] 11A and 11B, an exemplary injection device 10 is shown. The injection device 10 is configured to inject a medication into a user's body, as described above. The injection device 10 includes a housing 11, which typically houses a reservoir (e.g., a syringe) containing the medication to be injected and components required to facilitate one or more steps of the delivery process. As shown, the housing 11 is formed into an ergonomic shape. The housing 11 is generally rectangular in shape, with one side enlarged to form a curved outer surface 13. The curved outer surface 13 improves the fit of the housing in a user's hand, allowing the injection device 10 to be held without forming a fist or pinch grip. The edges of the housing 11 are generally rounded for user comfort when holding the injection device 10.

[0144] The injection device 10 can also include a cap assembly 12 that can be removably attached to the housing 11. Typically, a user must remove the cap 12 from the housing 11 before they can operate the injection device 10. The cap 12 includes a ring for pulling the cap 12 from the housing 11. The inner diameter of the ring is large enough to allow a user to slip a finger through the ring and pull the cap 12. In this way, the cap 12 can be pulled without forming a pinch grip. The enlarged, curved outer surface 13 of the housing 11 prevents the injection device 10 from slipping out of the user's hand when the cap 12 is pulled, even with only a loose grip.

[0145] The housing 11 has a distal region 20 and a proximal region 21. The term "distal" refers to a location relatively closer to the injection site, and the term "proximal" refers to a location relatively further from the injection site.

[0146] Insertion of needle 17 can occur via several mechanisms. For example, needle 17 can be fixedly positioned relative to housing 11 and can initially reside within an extended needle sleeve. By pressing the distal end of the sleeve against the user's body and moving housing 11 distally, the sleeve moves proximally, exposing the distal end of needle 17. Such relative movement allows the distal end of needle 17 to extend into the user's body. Such insertion is referred to as "manual" insertion because the user manually inserts needle 17 via manually moving housing 11 relative to the sleeve.

[0147] Another form of insertion is "automated," whereby the needle 17 moves relative to the housing 11. Such insertion can be triggered by movement of a sleeve or another form of activation, such as a button. The button can be located at the proximal end of the housing 11, or in other embodiments, the button can be located on the side of the housing 11.

[0148] Other manual or automated functions can include injecting a medication or retracting the needle, or both. Injection is the process of moving a bung or piston from a proximal position within a syringe (not shown) to a more distal position within the syringe, forcing the medication out of the syringe and through the needle 17. In some embodiments, before device 10 is activated, a drive spring (not shown) undergoes compression. The proximal end of the drive spring can be secured within the proximal region 21 of housing 11, and the distal end of the drive spring can be configured to apply a compressive force to the proximal face of the piston. After activation, at least a portion of the energy stored within the drive spring can be applied to the proximal face of the piston. This compressive force can act on the piston, moving it distally. Such distal movement compresses the liquid medication within the syringe and acts to force the medication out of the needle 17.

[0149] After injection, needle 17 can be retracted into sleeve or housing 11. Retraction can occur when the sleeve moves distally as the user removes device 10 from the user's body. This can occur because needle 17 remains fixedly positioned relative to housing 11. After the distal end of the sleeve passes over the distal end of needle 17 and needle 17 is sheathed, the sleeve can be locked. Such locking can include locking any proximal movement of the sleeve relative to housing 11.

[0150] Another form of needle retraction can occur when needle 17 is moved relative to housing 11. Such movement can occur when a syringe within housing 11 is moved proximally relative to housing 11. This proximal movement can be achieved through the use of a retraction spring (not shown) located within distal region 20. When activated, the compressed retraction spring can provide sufficient force to the syringe to move it proximally. After sufficient retraction, a locking mechanism can lock any relative movement between needle 17 and housing 11. Additionally, a button or other component of device 10 can be locked, if desired.

[0151] It will be understood that the above-described embodiments are purely illustrative and not limiting with respect to the scope of the claims. Other variations and modifications will be apparent to those skilled in the art upon reading the present application, some of which are described below.

[0152] The case of the packaging arrangement can be generally rectangular in shape or any other shape suitable for housing multiple syringes. The case can be of a shape and size suitable for placement in a home refrigeration unit.

[0153] The case can be configured to enclose the syringes and can be sealed. Alternatively, the case can be configured as a structure for externally supporting multiple injection devices. The syringes can be arranged in one or more rows, for example, in a single row of six or double rows of three, or in a circular arrangement. The syringes can be arranged to hang below the support structure.

[0154] The case can be configured to hold any number of injection devices depending on the medication dosing requirements. For example, the case can hold 5 to 15 injection devices. The case can be sized to hold enough injection devices for a three- or six-month period. If the medication is administered more regularly, the case can hold enough syringes for one week.

[0155] The case can be formed from an opaque material. One or more of the case's components can be formed to have at least a transparent portion. The transparent portion of the case can allow a user to see the number on the injection device or to see the user interface. One or more of the case's components can be translucent to improve visibility of the visual reminder output.

[0156] The case can be formed from a plastic material such as polyethylene, polystyrene, polycarbonate, or any other suitable material. Desirable properties for the case material include temperature stability, adequate impact strength, resistance to cleaning solutions, a wipe-clean finish, and rigidity.

[0157] Each component of the case can be formed from a single piece, such as a molded plastic component. Alternatively, multiple components can be machined. The body of the case can be formed from two components joined or attached together, or it can be formed from a single component. The interior of the case can be formed as a single large cavity, a cavity divided into multiple sections for holding each syringe, or multiple cavities for holding each syringe individually.

[0158] The case can contain any number of magnets sufficient to support the weight of the packaging arrangement and the injection device. For example, the case can contain two larger magnets or an arrangement of six smaller magnets. The magnets can be any permanent magnet or rare earth magnet. The magnets can be made of neodymium or samarium-cobalt.

[0159] The case may further include one or more ventilation apertures to allow air to flow into the case. Alternatively, the case may be sealed when the lid is in the closed position. The lid may further include a rubber seal to prevent air from passing between the lid and the case and entering the case. The case may be insulated to maintain a low temperature for the syringes when removed from the refrigerator for a short period of time.

[0160] The lid can be connected to the case by a hinge. The mechanism connecting the lid to the case and allowing the lid to open and close can take any suitable form. Instead of the hinge mechanism described above, the hinge can be a butt hinge, a living hinge, or some other type. The lid can be connected to the case by a flexible and / or elastic material. The hinge can allow some translational movement and pure rotational movement, allowing for better visibility or access to the interior of the case when the lid is open.

[0161] The hinge can allow a user to remove the lid. For example, the protrusions on each of the second hinged members can be pushed inward to disengage from the respective first hinged members, decoupling the lid from the case. The user can be provided with one or more alternative lids, which can be of different designs, for example, different colors. The alternative lids can have larger transparent portions or can be completely opaque.

[0162] Alternatively, the lid can be slidably engaged with the case. The lid can include runners on its edges, each runner configured to engage a corresponding groove on the case. The lid can slide out of the grooves and decouple from the case. The lid can be positioned to slide to the limits of the grooves and pivot freely in the open position. As a further alternative, the lid can be separate from the case and fixedly attached to the case by a friction fit. The lid can fit securely within an opening located at the front end of the case or can fit over the front of the case.

[0163] The lid may include a latch for maintaining the lid in a closed position. The latch may include a sliding catch arranged to slidably move between a first position and a second position. The catch may be arranged to protrude from an edge of the lid in the first position. The catch may be configured to slidably retract so as not to protrude in the second position. The latch may include a spring for biasing the catch to the first position. The catch may be configured to engage with an opening in the case in the first position when the lid is in the closed position. The catch may engage with the opening to maintain the lid in the closed position.

[0164] The latch can be a spring-loaded push-catch push-release mechanism. The latch can be configured to engage the closed position with a first push to maintain the lid in the closed position. The latch can be configured to disengage with a second push to allow the lid to open. The latch can be configured to engage when the lid is closed to hold the lid in the closed position. The latch can further include a release switch for disengaging the latch and allowing the lid to open. The release switch can be a mechanical switch or an electrical switch. The release switch can be an electrical switch coupled to the code input and configured to disengage the lid catch when the correct code is entered.

[0165] Although the lid open sensor has been described as an electromechanical switch, the lid open sensor may instead be an optical sensor device, a magnetic sensor device, or any other suitable device configured to detect whether the lid is open or closed, or whether the lid is transitioning from a closed position to an open position.

[0166] The packaging assembly may include a case without a lid. The packaging assembly may not include a lid-open sensor. Instead, the speaker may be deactivated by the processor device in response to an alert timer. The processor device may be configured to operate the alert timer. The processor device may activate the alert timer when the speaker is controlled to output an audio reminder alert that the scheduled medication time has arrived. The processor device may activate the alert timer when the scheduled medication time has arrived, provided that the refrigerator door is open. The processor device may deactivate the speaker when the alert timer reaches 30 seconds. Alternatively, the processor device may activate the alert timer at 20 seconds and count down until the timer expires. The processor device may be configured to deactivate the speaker when the alert timer expires. The validity period for the alert timer may be between 5 and 60 seconds.

[0167] The electronic system can include a syringe sensor for determining whether a syringe is located in one of the plurality of openings. The syringe sensor can determine whether a syringe is located in each of the openings. The processor device can be configured to deactivate the speaker when the syringe sensor indicates that the syringe has been removed from an opening.

[0168] The syringe sensor may include one or more syringe switches. The syringe switches may each be positioned within the opening. Each syringe switch may be a mechanical switch. The syringe switches may be normally open switches that are depressed to a closed position by the syringe pen when in position within the opening. The syringe switches may be membrane switches. The syringe switches may be activated by a lever located within the opening.

[0169] Each syringe switch can be configured to send a signal to the processor device when a syringe is positioned within the corresponding opening. The processor device can be configured to deactivate the speaker when it no longer receives a signal from the syringe switch. The processor device can be further configured to reset a countdown to the scheduled dosing time when the syringe is removed from the opening. Alternatively, if the syringe is replaced within the case after a dose has been administered, the processor device can be configured to reset the countdown when the syringe is replaced. The processor device can be configured to monitor the number of syringes in place within the packaging assembly. The processor device can control a display to indicate the number of syringes in the packaging assembly. The processor device can control an electronic system to provide a notification output when the packaging assembly is empty.

[0170] The retention mechanism can be located at the bottom end of the case. The retention mechanism can be arranged to engage the end of each syringe that passes through the opening. The retention mechanism can include a plurality of additional openings at the bottom end of the case. The additional openings can be sized to hold the syringes in place by a friction fit. Alternatively, the retention mechanism can include a lever-type pinch device arranged to grip the sides of the syringe when the syringe is pushed longitudinally into the device and release the syringe when the syringe is withdrawn longitudinally from the device.

[0171] The retention mechanism may include a release switch configured to disengage the retention mechanism. The release switch may be configured to release one or all of the syringes. Multiple release switches may be provided for a corresponding number of syringes. The release switch may be a mechanical switch or a lever coupled to the retention mechanism. The release switch may be further coupled to the ejection mechanism. The release switch may be an electromechanical switch. The release switch may be controlled by a processor device. The processor device may control the release switch to disengage the retention mechanism on the condition that a scheduled dose time has occurred. The processor device may control the release switch to disengage the retention mechanism for one syringe when the scheduled dose time has occurred. The retention mechanism may be controlled to release one syringe that has been partially pushed out of the opening by the ejection mechanism. The device may provide a visual reminder alert in the form of a portion of the syringe being pushed out of the opening.

[0172] The band of the ejection mechanism can be formed from any suitable flexible material. For example, the band can be made from cloth, rubber, silicone, or any other suitable material. The ring at the second end of the band can be formed from plastic, or alternatively from metal, rubber, wood, or any other suitable material. The ring can be attached to the band or can be integral with the band.

[0173] The ejection mechanism can include a motorized actuator. For example, a roller positioned perpendicular to the syringes can be driven to push the syringes out of the opening. The roller can push all of the syringes equally, and the retention mechanism can be configured to hold all but one of the syringes in place. Alternatively, the actuator can include a protruding member from the rear of the case that is driven laterally across the width of the case. The protruding member can be driven along a rail or can protrude from a belt that extends along the width of the case. The protruding member is configured to engage each syringe in turn and push them out of the opening.

[0174] The time period for the reminder can be any suitable dosing period depending on the medication contained in the packaging assembly. The time period set until the next scheduled dosing time can be any number of days, for example, 2 to 60 days. The time period can be several weeks, for example, 7, 14, 21, or 28 days. The time period can be 28 days, i.e., 4 weeks, or the time period can be 1 month.

[0175] Alternatively, the time period can be one or two days, and the display can be configured to show the number of hours until the scheduled dosing time. Similarly, for time periods on the order of hours, the display can show the number of minutes.

[0176] The timer duration switch can be configured to select between any two periods. For example, a first switch position can correspond to a 7-day period, and a second switch position can correspond to a 14-day period. Alternatively, the timer duration switch can be a multi-position switch, such as a rotary switch or a dial. The period can be set with a display, where a first user input causes the display to indicate the current period, and a second input is used to adjust the period.

[0177] The reset timer can operate for any suitable time frame. For example, the reset button can be configured to reset the countdown timer if pressed for 1 second or up to 5 seconds.

[0178] The display can include three or more LED arrays to accommodate more numbers and messages, or can be only a single LED array. Alternatively, the display can include any form of electronic display suitable for displaying numbers and / or messages, for example, the display can be an array of LED pixels, an LCD or e-paper screen, or a split-flap display. The display can be located in a peripheral module separate from the case. The display module can be connected to the electrical system by a wired or wireless connection. The electronic system can include any display driver suitable for the selected display.

[0179] The display can be configured to provide further status information or further details in the form of a text message on the display. For example, the display can provide a visual reminder that the scheduled dosing time has arrived by showing a reminder message in addition to, or instead of, flashing the number 00. The output of the number 00 is an example of a reminder message. The display can be controlled to indicate the number of syringes remaining in the packaging assembly. The processor device can be configured to determine the number of syringes in response to input from a syringe sensor. Alternatively, the processor device can be configured to monitor the number of times the scheduled dosing time has passed. The display can be controlled to show a notification message when the packaging assembly is empty.

[0180] The processor device can be configured to deactivate the user interface display when the case lid is closed. The processor device can activate an LED based on a refrigerator open sensor to indicate to the user that the status of the packaging assembly is normal when the number of days remaining is two or more, regardless of whether the lid is closed. The user can open the lid, if needed, to activate the display to indicate the number of days. When it is time to administer the medication, the processor device can activate both the LED and the display to flash to provide a visual reminder, regardless of whether the lid is open.

[0181] More than one LED can be included in the user interface to provide a more detailed indication of the status of the packaging assembly. For example, a status LED having a first color can be activated when there are two or more days until the scheduled dosing time, the status LED can flash when there is one day left, and a second LED having a second color can be activated when the scheduled dosing time arrives. Alternatively, a single bi-color LED can be used. Alternatively, any other form of notification light or visual output transducer can be used instead of an LED.

[0182] The packaging assembly of any embodiment can be provided with multiple LEDs corresponding to the multiple openings. These LEDs can be controlled as described with respect to the fourth embodiment. Alternatively, the processor unit can cause one of the multiple LEDs to flash or blink while the remaining LEDs are turned off or illuminated continuously. A different LED can also be controlled to flash each time to guide the user to use the next syringe. One LED can also flash in a different color. The processor unit can control the multiple LEDs depending on the number of injection devices remaining in the packaging assembly.

[0183] The speaker can be any suitable form of audio output transducer, such as an electroacoustic transducer, a piezoelectric buzzer, a moving diaphragm speaker, or a mechanical bell. A vibration alert can also be used instead of or in addition to an audio output transducer.

[0184] A refrigerator open sensor may be included, which may include a phototransistor, or alternatively a photoresistor or photodiode. Alternatively, the refrigerator open sensor may include a mechanical switch. The refrigerator open sensor may be located on the exterior of the case, on the hinge or frame of the refrigerator door, or may be a mechanical switch positioned to be depressed by the refrigerator door in the closed position.

[0185] A door open timer can be run, for example the user interface can go into partial sleep mode if the refrigerator door is open for 10 or 15 minutes.

[0186] Alternative countdown timer implementations include off-chip and on-chip state-based logic circuits with clock devices, and other forms will be apparent to those skilled in the art.

[0187] The PCB and components of an electronic system can be encapsulated for protection. For example, a PCB can be coated on each side with a waterproof lacquer or another suitable coating. An electronic system can be coated to protect it from the moisture or humidity inside a home refrigerator.

[0188] The packaging assembly can include more or fewer batteries depending on the power requirements of the electronic system. For example, the packaging assembly can include a single battery power pack. The one or more batteries can be removable and replaceable, or can be fixed within the case of the packaging assembly. Alternatively, the packaging assembly can be adapted to mains power or any alternative power source.

[0189] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease or otherwise improve physical or mental well-being. Drugs or medications can be used for a limited duration or periodically for chronic disorders.

[0190] As described below, drugs or pharmaceutical agents may contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules with a molecular weight of 500 Da or less, 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 can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0191] The term "drug delivery device" is intended to encompass any type of device or system configured to administer a drug or agent to a human or animal body. Without limitation, a drug delivery device can be an injection device (e.g., a syringe, pen injector, auto-injector, or other device configured for intraocular, subcutaneous, intramuscular, or intravascular delivery), a skin patch (e.g., osmotic, chemical, microneedle), or an inhaler (e.g., nasal or pulmonary). The drugs described herein may be particularly useful in injection devices that include a needle, e.g., a hypodermic needle, e.g., having a gauge of 24 or greater.

[0192] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can 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 can be designed to store the drug for about one month to about two years. Storage can occur at room temperature (e.g., about 20°C) or refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components prior to and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0193] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary embolism. Further examples of disorders include acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as Rote Liste 2014 (e.g., but not limited to, Main Group 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0194] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative; glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof; a dipeptidyl peptidase-4 (DPP4) inhibitor; or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to any substance that is sufficiently structurally similar to the original substance so as to have substantially the same functionality or activity (e.g., therapeutic effect). In particular, the term "analog" refers to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residues can be either codable amino acid residues, other naturally occurring residues, or purely synthetic amino acid residues. Insulin analogs are also called "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, for example, the molecular structure of human insulin, with one or more organic substituents (e.g., fatty acids) attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-encodable amino acids, or amino acids, including non-encodable ones, are added to the naturally occurring peptide.

[0195] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and the 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.

[0196] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); 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-ThrB29LysB30 human insulin. B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0197] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin -4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C, CM-3, GLP-1 Erigen, ORMD-0901, NN-9924, NN-9926, NN-9927, nodexene, Viadol-GLP-1, CVX-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.

[0198] An example of an oligonucleotide is, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia.

[0199] Examples of DPP4 inhibitors are vidagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0200] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0201] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low-molecular-weight heparin or ultra-low-molecular-weight heparin or derivatives thereof, or sulfated polysaccharides, such as the polysulfated forms of the aforementioned polysaccharides, 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 Hylan G-F20 (Synvisc®) and sodium hyaluronate.

[0202] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, antibody fragment, or mutant that does not support Fc receptor binding, e.g., has a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins (CODVs) with a crossover binding region orientation.

[0203] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, e.g., bivalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0204] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and that are primarily responsible for maintaining the proper orientation of the CDR sequences to enable antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDRs to interact with the antigen.

[0205] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0206] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use as drugs or medicaments in drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0207] It will be understood by those skilled in the art that modifications (additions and / or deletions) can be made to the various components of the APIs, formulations, devices, methods, systems, and embodiments described herein without departing from the full scope and spirit of the invention, and that the present disclosure encompasses such modifications and all equivalents thereof.

Claims

1. 1. A packaging assembly comprising: a case configured to at least partially house a plurality of injection devices for delivering medication, the case being formed as a box having at least one opening; and at least one tray configured to accommodate at least one of the plurality of injection devices and arranged to slide out of the case through the opening, wherein each of the plurality of trays is configured to rotate about its longitudinal axis so that the open side of the tray faces downward and the injection device accommodated therein falls out of the tray.

2. The packaging assembly of claim 1 , comprising one tray for each of a plurality of injection devices.

3. A packaging assembly as described in claim 1, wherein each tray includes one or more retaining grooves or rails configured to maintain the tray in an upward orientation as it slides in and out of its corresponding opening.

4. A packaging assembly as described in claim 3, wherein the retaining grooves or rails are configured to allow each tray to rotate after the tray is completely removed from the case.

5. A packaging assembly as described in claim 1, wherein each tray includes a retaining lip at one end of the tray, the retaining lip configured to prevent the tray from being completely removed from the case.

6. A packaging assembly as described in claim 1, wherein the outer end of each tray includes a ring for pulling the tray, and the inner diameter of the ring is large enough to allow a finger to be passed through the ring to pull the tray.

7. The packaging assembly of claim 1, further comprising a retention mechanism configured to lock one or more of the trays in position when fully inserted into the case.

8. A packaging assembly comprising: a case configured to at least partially house a plurality of injection devices for delivering medication, the case being formed as a box having at least one opening; and at least one tray configured to accommodate all of the plurality of injection devices and arranged to slide out of the case through the opening, wherein the tray is configured to hinge around an edge of the tray adjacent to the case when fully pulled out of the case.

9. the tray is configured to receive a plurality of injection devices in an arrangement in which each injection device is positioned perpendicular to a direction in which the tray is configured to slide; 9. The packaging assembly of claim 8, wherein the side panel of the tray includes at least one opening for ejecting one or more of the injection devices from the tray.

10. 10. The packaging assembly of claim 9, wherein the tray is formed with at least one sloped portion positioned to lift one or more of the injection devices from the tray when pushed through the at least one opening in the side panel.

11. the tray is configured to accommodate a plurality of injection devices in an arrangement in which each injection device is positioned parallel to a direction in which the tray is configured to slide; 9. The packaging assembly of claim 8, wherein the bottom plate of the tray includes at least one opening for pushing one or more of the injection devices upwardly from the tray.

12. A packaging assembly as described in claim 11, wherein the bottom plate of the tray includes a plurality of openings corresponding to the number of injection devices.

13. The packaging assembly of claim 11, comprising a plurality of partitions arranged to hold a plurality of injection devices in fixed positions within the tray.

14. A packaging assembly as described in claim 13, wherein the opening is located between the partitions at the front end of the base.

15. A packaging assembly as described in claim 11, wherein the diameter of each opening is large enough for a user to insert a finger to lift the injection device from the tray.

16. A packaging assembly as described in claim 11, wherein a retaining element is positioned at the rear end of the tray to prevent the tray from being completely removed from the case.

17. A packaging assembly as described in claim 11, wherein the tray is configured to pivot downward when completely removed from the case.

18. The packaging assembly of claim 11, further comprising a plurality of injection devices.

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