Auto-injector storage device

Abstract

A storage device for storing a plurality of auto-injectors, the storage device being configured to activate the auto-injectors when the auto-injectors are removed from the device.

Description

Field of the Technology

[0001] The present invention relates to a device for storing a plurality of autoinjectors.

Background Art

[0002] Current therapies delivered by self-administered injections include drugs for diabetes (both insulin and new GLP-A class drugs), migraines, hormone therapy, anticoagulants, etc. Drug delivery devices such as autoinjectors aim to make it easier for the user to self-administer injection therapies. An autoinjector is a device that replaces all or part of the actions involved in drug delivery of a manual device.

Summary of the Invention

Means for Solving the Problems

[0003] According to one aspect of the present invention, a storage device for storing a plurality of autoinjectors is provided. The device is configured to activate the autoinjector when the autoinjector is removed from the device. This makes it possible to keep the autoinjector in a stored state until it is ready for use by the end user, ensuring correct activation of the autoinjector with minimal effort on the user's part. This is particularly suitable when the end user has little or no medical experience.

[0004] The device can be configured to activate the autoinjector by at least partially opening a blister pack containing the autoinjector. Thus, the autoinjector is kept sterile until it is ready for use by the end user.

[0005] The device can also be configured to activate the autoinjector by making a change to the autoinjector. This interaction between the device and the autoinjector provides a simple means of activating the autoinjector that requires minimal input from the user.

[0006] The device can also be configured to activate the auto-injector by interrupting or completing the auto-injector's electrical circuit. The auto-injector can then be kept in a low-power idle state until it is ready for use by the end user, thus saving power.

[0007] The device can also be configured to activate the auto-injector by removing a part of it. This is a simple way to activate the auto-injector with minimal input from the user.

[0008] The device may include an auto-syringe and a connector connected to the surface of the device, where the connector is configured to decouple from the auto-syringe and activate the auto-syringe. This is a particularly simple means of activating the auto-syringe.

[0009] The device may include a blister pack configured to contain an auto-injector, where the connector is connected to both the blister pack and the auto-injector and is configured to decouple from the auto-injector and activate the auto-injector. This is a particularly simple means of activating the auto-injector by the end user.

[0010] The device may include a box configured to contain an autosyringer. The device may include a dispenser positioned to dispense the autosyringers contained in the box. The dispenser is configured to prevent the simultaneous removal of two or more autosyringers from the device. This arrangement can prevent accidental or intentional activation of more than one autosyringer and thus encourages the use of the first autosyringer before removing a second one.

[0011] The dispenser may include a drawer that can move between an open and a closed position, and the automatic syringe can be removed from the device via the drawer when it is in the open position. This is a particularly simple means of enabling the removal of the automatic syringe.

[0012] The device can be configured to prevent the subsequent storage of an auto-syringe within the device after it has been removed from the device and activated. By preventing the storage of an already activated auto-syringe, it is ensured that each auto-syringe is removed from the device, newly activated, and therefore in good condition for use.

[0013] The device can be configured to activate an auto-syringe by changing the geometry of the auto-syringe from a first state to a second state. The device is configured to retract the auto-syringe when it is in the first state, and further configured to prevent the auto-syringe from being retracted within the device when it is in the second state. This is a particularly simple and effective means of preventing the retraction of an already activated auto-syringe.

[0014] The device may include a control unit; a sensor coupled to the control unit; and an actuator coupled to the control unit. The control unit is configured to determine, based on a signal from the sensor, whether the auto-syringe is activated; and, in response to determining that the auto-syringe is activated, to send a signal to the actuator, which moves the actuator from a first position in which the auto-syringe can be housed in the device to a second position in which the auto-syringe cannot be housed in the device. This is a particularly simple and effective means of preventing the housing of an already activated auto-syringe.

[0015] According to another aspect of the present invention, a system is provided comprising any of the above-described devices and a plurality of auto-injectors containing a drug. This allows the auto-injectors to be kept in a stored state until they are ready for use by the end user, ensuring that the auto-injectors are properly activated with minimal effort on the part of the user. This is particularly suitable when the end user has little or no medical experience.

[0016] The system may further include a startup indicator configured to show the user that the auto-injector has been started. This can increase the user's confidence that the auto-injector has been successfully started and can prevent the user from attempting to return and store the started auto-injector back into the device.

[0017] The system may include a temperature indicator configured to show the user the temperature of the auto-syringe. The temperature indicator is activated when the auto-syringe is removed from the device. The auto-syringe can be stored at a suitable temperature until the user needs it, and the user can be aware from the temperature indicator that the auto-syringe is at a suitable temperature for injection.

[0018] Exemplary embodiments of the present invention will be described with reference to the attached drawings. [Brief explanation of the drawing]

[0019] [Figure 1A] This is a side view of an automatic syringe suitable for use with embodiments of the present invention. [Figure 1B] This is a side view of an automatic syringe suitable for use with embodiments of the present invention. [Figure 2A] Figures 1A and 1B are schematic diagrams of the circuits of the automated injection device. [Figure 2B] This is a partial cross-sectional view of an automatic syringe storage device and an automatic syringe according to one embodiment of the present invention. [Figure 2C] This is a partial cross-sectional view of an automatic syringe storage device and an automatic syringe according to one embodiment of the present invention. [Figure 3] This is a cross-sectional view of an automatic syringe storage device and an automatic syringe according to one embodiment of the present invention. [Figure 4] This is a cross-sectional view of an automatic syringe storage device and an automatic syringe according to one embodiment of the present invention. [Figure 5A] Front view of a plurality of blister packs suitable for use with an embodiment of the present invention that houses an autoinjector.

Figure 5B

Figure 5C

Figure 6A

Figure 6B

Figure 7A

Figure 7B

Figure 8

Figure 9

Mode for Carrying Out the Invention

[0020] Next, embodiments of the present invention illustrated in the accompanying drawings will be described in detail. Throughout the drawings, the same reference numerals indicate the same elements.

[0021] A storage device for storing a plurality of autoinjectors, and a system including the storage device and the plurality of autoinjectors are provided. The storage device is configured to activate (automatically) at least one of the autoinjectors in response to removing the autoinjector from the device.

[0022] Drug delivery devices as described herein can be configured to inject a drug into a patient. For example, delivery can be performed subcutaneously, intramuscularly, or intravenously. Such devices can be operated by the patient or by a healthcare professional such as a nurse or physician, and may include an auto-injector. The device may include a cartridge-based system in which a sealed ampoule needs to be punctured before use. The volume of drug delivered using these devices can range from about 0.5 ml to about 2 ml.

[0023] In combination with specific drugs, the drug delivery devices described herein can also be customized to operate within the required range of specifications. For example, a device can be customized to inject a drug within a specific time frame (e.g., approximately 3 to 20 seconds for an auto-injector). Other specifications may include low or minimal discomfort levels, or specific conditions related to human factors, shelf life, expiration date, biocompatibility, environmental considerations, etc. Such variations may arise from various factors, such as the viscosity of the drug ranging from approximately 3 cP to approximately 50 cP. Therefore, drug delivery devices often include hollow needles of approximately 25 to 31 gauge. Common sizes are 27 and 29 gauge.

[0024] The delivery devices described herein may also include one or more automated functions. For example, one or more of the following may be automated: needle insertion, drug injection, and needle retraction. Energy for one or more automated processes 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 the movement of one or more components of the device.

[0025] Each of the automatic functions of an auto-injector is triggered via a trigger mechanism. Such a trigger mechanism may include one or more of a button, lever, needle sleeve, or other trigger components. The triggering of an automatic function may be a one-step or multi-step process. That is, the user may need to trigger one or more trigger components to activate an automatic function. For example, in a one-step process, the user may be able to push the needle sleeve down against their body to administer a drug injection. Other devices may require the automatic function to be triggered by multiple steps. For example, the user may need to push down a button and retract the needle shield to administer an injection.

[0026] Furthermore, the triggering of one automated function can trigger one or more subsequent automated functions, thereby forming a trigger sequence. For example, the triggering of a first automated function can trigger at least two of the following: needle insertion, drug injection, and needle retraction. Some devices require a specific process sequence to perform one or more automated functions. Other devices can operate with independent process sequences.

[0027] Some delivery devices may incorporate one or more functions of a safety syringe, a pen injector, or an autoinjector. For example, a delivery device may include a mechanical energy source (typically found in autoinjectors) configured to automatically inject the drug, and a dose setting mechanism (typically found in pen injectors).

[0028] Figures 1A and 1B show an exemplary auto-injector 10 suitable for use in embodiments of the present invention. As previously stated, the auto-injector 10 is configured to inject a drug into a patient's body. The auto-injector 10 includes a housing 11, which typically houses a reservoir (e.g., a syringe) containing the drug to be injected, and components necessary to facilitate one or more steps in the delivery process. The auto-injector 10 may also include a cap assembly 12 that can be detachably attached to the housing 11. Typically, the user must remove the cap 12 from the housing 11 before operating the auto-injector 10.

[0029] As shown in the figure, the housing 11 is substantially cylindrical and has a substantially constant diameter along the longitudinal axis X. The housing 11 has a distal region 20 and a proximal region 21. The term "distal" refers to a location relatively close to the injection site, and the term "proximal" refers to a location relatively far from the injection site.

[0030] The automatic syringe 10 may also include a needle sleeve 13 connected to the housing 11 so as to be able to move relative to the housing 11. For example, the sleeve 13 may be able to move longitudinally parallel to the longitudinal axis X. Specifically, proximal movement of the sleeve 13 may allow the needle 17 to extend from the distal region 20 of the housing 11.

[0031] The insertion of the needle 17 is performed by several mechanisms. For example, the needle 17 is fixedly positioned relative to the housing 11 and can initially be positioned within an extended needle sleeve 13. By placing the distal end of the sleeve 13 against the patient's body and moving the housing 11 distally, the proximal movement of the sleeve 13 exposes the distal end of the needle 17. Such relative movement allows the distal end of the needle 17 to extend into the patient's body. Such insertion is called "manual" insertion because the needle 17 is manually inserted by the patient manually moving the housing 11 relative to the sleeve 13.

[0032] Another insertion configuration is "automated," which causes the needle 17 to move relative to the housing 11. Such insertion can be triggered by the movement of the sleeve 13 or by another form of trigger mechanism, such as a button 22. As shown in Figures 1A and 1B, the button 22 is located at the proximal end of the housing 11. However, in other embodiments, the button 22 may be located on the side of the housing 11.

[0033] Other manual or automated functions include drug injection, needle retraction, or both. Injection is the process of moving a stopper or piston 23 from a proximal position in the syringe (not shown) to a more distal position in the syringe to pass the drug from the syringe to the needle 17. In some embodiments, a drive spring (not shown) is compressed before the auto-injector 10 is triggered. The proximal end of the drive spring can be fixed within the proximal region 21 of the housing 11, and the distal end of the drive spring can be configured to apply a compressive force to the proximal surface of the piston 23. After triggering, at least some of the energy stored in the drive spring is applied to the proximal surface of the piston 23. This compressive force acts on the piston 23, causing it to move distally. Such distal motion acts to compress the liquid drug in the syringe and push it out from the needle 17.

[0034] After injection, the needle 17 is retracted into the sleeve 13 or housing 11. Retraction may occur if the sleeve 13 moves distally when the user removes the auto-injector 10 from the patient's body. This can occur because the needle 17 remains fixed in place relative to the housing 11. The sleeve 13 locks when the distal end of the sleeve 13 passes the distal end of the needle 17 and the needle 17 is covered. Such locking can include locking of any proximal movement of the sleeve 13 relative to the housing 11.

[0035] Another form of needle retraction can occur when the needle 17 moves relative to the housing 11. Such movement can occur when the syringe within the housing 11 moves proximal to the housing 11. This proximal movement is achieved by using a retraction spring (not shown) located in the distal region 20. When the compressed retraction spring is activated, it can supply sufficient force to the syringe to move it proximal. After sufficient retraction, any relative movement between the needle 17 and the housing 11 is locked by the locking mechanism. In addition, the button 22 or other components of the auto-injector 10 are locked as needed.

[0036] An automatic syringe, such as the automatic syringe 10, may need to be activated before it is ready for use in injection. In this context, activating the automatic syringe 10 can mean changing its state from a stored state to an intermediate state. For example, the automatic syringe 10 may be configured so that the device cannot be triggered in the stored state. As described below, this may include a safety tab or other structural feature that prevents or limits the triggering of the device. In contrast, the intermediate state may allow the device to be triggered. For example, after the safety tab is removed, the automatic syringe 10 can be used for injection. Mechanical or electrical components may be used to activate the automatic syringe 10, as described below.

[0037] If the automatic syringe 10 includes an electronic circuit used for performing the injection process, activating the automatic syringe 10 may include bringing the circuit into a state where injection can be performed. The circuit may be in a dormant state, and therefore when the automatic syringe 10 is activated, the circuit is brought out of the dormant state.

[0038] In other examples, activating the auto-injector 10 may include physically activating the auto-injector 10, such as activating the mechanical functions of the auto-injector 10 during injection preparation. For example, activation may include removing or unlocking the safety grip of the auto-injector, or opening a valve to allow multiple drugs to be mixed before injection.

[0039] According to some embodiments of the present invention, the automatic syringe storage device 100 is configured to activate the automatic syringe 10 by interrupting or completing the electrical circuit 30 of the automatic syringe 10.

[0040] Figure 2A is a schematic diagram of an electrical circuit 30 included in an auto-injector 10 suitable for use with embodiments of the present invention. The circuit 30 includes a processor unit (arrangement) 31 and a memory 32, which together work to control the operation of one or more functions of the auto-injector 10. The circuit 30 further includes a battery 33 or other power source to supply power to the processor unit 31 and other components of the circuit 30. The circuit 30 may further include a motor 34 for driving one or more mechanisms of the auto-injector 10. The circuit 30 may further include an input button 35. The input button 35 is activated by the user of the auto-injector 10, thereby providing an input to the circuit 30, allowing the processor unit 31 to control the operation of the functions of the auto-injector 10. For example, activation of the input button 35 can initiate the delivery of medication from the syringe of the auto-injector 10.

[0041] The automatic syringe storage device 100 can be configured to activate the automatic syringe 10, which includes the circuit 30, by interrupting at least a portion of the circuit 30. In other words, the device 100 can be configured to interrupt the electrical connection of the circuit 30. This electrical connection is provided by a switch 36 that forms part of the circuit 30. In response to the automatic syringe 10 being removed from the storage device 100, the switch 36 is moved from the closed position to the open position, thereby interrupting a portion of the circuit 30. The processor device 31 senses this opening of the switch 36, thereby activating the automatic syringe 10.

[0042] Figure 2B is a cross-sectional view of a portion of the automatic syringe housing device 100 and the end of the automatic syringe 10 according to one embodiment of the present invention. The automatic syringe 10 includes two electrical contacts 37a and 37b located on the surface of the housing 11 of the automatic syringe 10. The automatic syringe housing device 100 includes an electrical connector 38 located on the surface of the device 100. When the automatic syringe 10 is housed in the device 100, the connector 38 is in contact with the two electrical contacts 37a and 37b, thereby forming an electrical connection between contacts 37a and 37b. When the automatic syringe 10 is removed from the device 100, the electrical contact between the two electrical contacts 37a and 37b via the connector 38 is interrupted. This is detected by the processing unit 31 of the circuit 30 connected to the two electrical contacts 37a and 37b, and as a result the automatic syringe 10 is activated.

[0043] The automatic syringe storage device 100 can also be configured to activate the automatic syringe 10, which includes the circuit 30, by completing at least a portion of the circuit 30. In other words, the device 100 can be configured to form an electrical connection between two components of the circuit 30. This electrical connection can again be brought about by a switch 36, which also forms part of the circuit 30. In response to the automatic syringe 10 being removed from the storage device 100, the switch 36 is moved from the open position to the closed position, thereby completing part of the circuit 30. The processor device 31 senses this closing of the switch 36, thereby activating the automatic syringe 10.

[0044] Figure 2C is a cross-sectional view of a portion of an automatic syringe housing device 100 and an end of an automatic syringe 10 according to one embodiment of the present invention. The automatic syringe 10 includes two electrical contacts 37a, 37b, which are shown here contained within the housing 11 of the automatic syringe 10, although the two electrical contacts 37a, 37b may be located elsewhere relative to the housing 11, for example, on the outer surface of the housing 11. The automatic syringe housing device 100 includes a projection 39 located on the surface of the device 100. When the automatic syringe 10 is housed in the device 100, the projection 39 holds the two electrical contacts 37a, 37b apart, thereby interrupting any electrical connection between electrical contacts 37a and 37b. When the automatic syringe 10 is removed from the device 100, the projection 39 is removed from between the two electrical contacts 37a, 37b. The two electrical contacts 37a, 37b are electrically connected, biased toward each other, for example by a spring, once the projection 39 is removed. Therefore, the removal of the protrusion 39 ultimately completes the electrical circuit 30. The processing unit 31 of the circuit 30 connected to two or more electrical contacts 37a and 37b senses the completion of electrical contact between the two electrical contacts 37a and 37b, and as a result, the automatic syringe 10 is activated.

[0045] The two electrical contacts 37a and 37b in Figures 2B and 2C form part of circuit 30. Disconnection of circuit 30, as shown in Figure 2B, is detected by the processor device 31. In response, the processor device 31 activates the automatic syringe 10. In this context, activating the automatic syringe 10 may include enabling one of the electrical functions of circuit 30, such as enabling the use of the input button 35 or the motor 34.

[0046] The completion of circuit 30, as shown in Figure 2C, is sensed by the processor unit 31. In response, the processor unit 31 activates the auto-syringe 10. In this context, activating the auto-syringe 10 may include enabling one of the electrical functions of circuit 30, such as making the input button 35 or the motor 34 usable. In some embodiments, completing circuit 30 may include completing the electrical connection between the battery 33 and one or more components of circuit 30, such as the processor unit 31. In other words, circuit 30 may initially not require a power supply. However, after the electrical circuit is completed in response to the removal of the auto-syringe 10 from device 100, power is supplied to circuit 30 from the battery 33.

[0047] In some embodiments of the present invention, device 100 is configured to activate the auto-syringe 10 by making a change to the auto-syringe 10 when the auto-syringe 10 is removed from device 100. In other words, removal of the auto-syringe 10 from device 100 may result in device 100 making a (physical) change to the auto-syringe 10. This change may be permanent or temporary.

[0048] Device 100 can be configured to activate the autosyringer 10 by making a mechanical (or physical) change to the autosyringer 10 when it is removed from device 100. For example, when the autosyringer 10 is removed from device 100, device 100 may mechanically move a part of the autosyringer 10 from a first position where the autosyringer 10 is stopped to a second position where the autosyringer 10 is activated. This part may be a valve of the autosyringer 10, in which case the valve is moved from the first position to the second position, and the autosyringer 10 is activated when the valve is in the second position. In another example, this part may be a safety grip, in which case the safety grip is moved from a first position where the autosyringer 10 is not ready for use to a second position where the autosyringer 10 is activated and ready for use.

[0049] In some examples, device 100 can be configured so that the user makes a mechanical change to the auto-syringe 10 when removing it from device 100. For example, device 100 can be configured to house the auto-syringe 10 such that the user must make a mechanical change to the auto-syringe 10 in order to remove it from device 100. This may include housing the auto-syringe 10 such that the user must activate a start button on the auto-syringe when removing it from device 100. When the start button is pressed, the auto-syringe 10 is activated. In some examples, the start button is activated by device 100 when removing the auto-syringe 10.

[0050] In some examples, mechanically moving a component of the autosynergy 10 from a first position to a second position may include the device 100 removing the component from the rest of the autosynergy 10. For example, this component could be a movement limiter that prevents some mechanical action of the autosynergy 10, such as pressing down a button. Mechanically moving this component of the autosynergy 10 from a first position to a second position may include the device 100 removing the movement limiter from the rest of the autosynergy 10, thereby enabling operation of the autosynergy 10 that was previously blocked. The component removed from the autosynergy 10 by the device 100 may be the cap 12 of the autosynergy 10, as described below.

[0051] Device 100 may be configured such that removing the auto-injector 10 from Device 100 requires a specific operation or series of operations by the user on the auto-injector 10 and / or Device 100. The operation or series of operations may include one or more movements of at least a part of the auto-injector 10 and / or Device 100. These movements may include rotational or translational motion. Device 100 may include restraint means configured to hold the auto-injector 10 and prevent its removal until the specific operation or series of operations is performed. The restraint means may include one or more recesses and / or protrusions arranged to engage with one or more corresponding recesses and / or protrusions on the auto-injector 10 to prevent the auto-injector 10 from being removed from Device 100 until the specific operation or series of operations is performed.

[0052] For example, the sequence of operations may include both linear translational and rotational motion of the auto-injector 10 relative to the device 100, so that the user must push down and twist the auto-injector 10 before removing it from the device 100. The need to perform a specific operation or sequence of operations can act as a childproof restriction on the removal and activation of the device, so that the auto-injector 10 can only be removed from the device 100 and thus activated when the correct operation or sequence of operations has been performed.

[0053] A specific operation or series of operations may also be performed by the user on the device 100, at least part of which may be performed. For example, the operation or series of operations may include the user squeezing a restraining means before removing the automatic syringe 10.

[0054] If the user has an interruption between removing the auto-syringe 10 from the device 100 and administering an injection, they may attempt to return the activated auto-syringe 10 to the device 100 for storage. However, if multiple auto-syringes 10 are stored in the device 100, there is a risk that the user may forget which auto-syringe 10 has already been activated (and therefore may have compromised sterility or reduced battery life). Therefore, in some embodiments of the present invention, the device 100 is configured to prevent the storage of an auto-syringe 10 in the device 100 after it has been removed from the device 100 and activated. In some examples, this can be achieved by mechanically modifying the auto-syringe 10, as previously described.

[0055] Device 100 can be configured to activate the auto-syringer 10 by changing the geometry of the auto-syringer 10 from a first state to a second state when the auto-syringer 10 is removed from device 100. Device 100 can be configured to house the auto-syringer 10 when it is in the first state. Device 100 can be further configured to prevent the auto-syringer 10 from being housed within device 100 when it is in the second state. For example, device 100 may include an aperture. The aperture has a geometry that allows the auto-syringer 10 to be received and housed in device 100 when it is in the first state, but the geometry of the aperture can prevent or prevent the auto-syringer 10 from being received through the aperture and housed in device 100 when it is in the second state.

[0056] Figure 3 is a cross-sectional view of an automatic syringe housing device 100 and an automatic syringe 10 according to one embodiment of the present invention. The automatic syringe 10 includes a cap 12. The device 100 in Figure 3 is configured to activate the automatic syringe 10 by removing the cap 12 from the automatic syringe 10. The cap 12 is removed in such a way that it cannot be reattached. The device 100 may include a removal means configured to remove the cap 12 from the automatic syringe 10.

[0057] Figure 3 shows device 100 including a projection 40 that acts as a removal means for removing the cap when the automatic syringe 10 is withdrawn from device 100 in the direction of the arrow. However, it should be understood that other means for removing the cap may also be provided.

[0058] Device 100 can remove the cap 12 so that it is completely removed from the rest of the auto-syringe 10 and remains inside device 100. However, in other examples, device 100 is configured to remove the cap 12, but the cap 12 remains with the rest of the auto-syringe 10. In other words, the cap 12 is loosened from the rest of the auto-syringe 10.

[0059] Removing the cap can be done by changing the geometric shape of the automatic syringe 10 as described above. In other words, the first state of the automatic syringe 10 is when the cap 12 is attached to the automatic syringe 10, and the second state of the automatic syringe 10 is when the cap 12 is removed from the automatic syringe 10.

[0060] In some embodiments, the projection 40 is configured to activate the auto-syringe 10 in another way, for example, by tearing packaging such as a blister pack 50 containing the auto-syringe 10. The projection 40 may be configured to tear the blister pack 50 when the auto-syringe 10 is removed from the device 100. The user can then remove the auto-syringe 10 from the blister pack 50 before injection. The projection 40 may include, for example, a blade configured to tear the blister pack 50.

[0061] Figure 4 is a cross-sectional view of an automatic syringe housing device 100 and an automatic syringe 10 according to one embodiment of the present invention. As can be seen from Figure 4, the device 100 includes an automatic syringe 10 and a connector 45 connected to the surface of the device 100. The connector 45 may be a tab. The connector 45 is configured to decouple from the automatic syringe 10 so as to activate the automatic syringe 10 when it is removed from the device 100.

[0062] When connector 45 is connected to the auto-syringe 10 and device 100, the auto-syringe 10 is in an inactive state. Connector 45 is decoupled (or removed) from the auto-syringe 10 by, for example, the user removing the auto-syringe 10 from device 100.

[0063] In one example of the non-activated state, the connector 45 connected to the auto-syringe 10 may cover the button 22 of the auto-syringe 10, thereby preventing the user from operating the button 22. When the auto-syringe 10 is removed from the device 100, the connector 45 is decoupled (or removed) from the auto-syringe 10, thereby exposing the button 22 and allowing the user to operate the button 22 and administer an injection. In another example, when the auto-syringe 10 is non-activated, the connector is either disconnecting or completing the electrical circuit 30 contained within the auto-syringe 10, thereby preventing the use of the auto-syringe 10. When the auto-syringe 10 is removed from the device 100, the connector 45 is decoupled (or removed) from the auto-syringe 10, thereby completing the circuit 30 if it was previously disconnected, or disconnecting it if it was previously completed, thereby activating the auto-syringe 10. Such completion or disconnection of the circuit has been described above.

[0064] In a further example, the connector 45 can be connected to the cap 12 of the auto-syringe 10, and the cap 12 is detached from the auto-syringe 10 by the connector 45 when the auto-syringe 10 is removed from the device 100. In another example, the connector 45 is attached to a mechanism of the auto-syringe 10, such as a safety grip or a valve. Removal of the auto-syringe 10 from the device 100 allows the connector 45 to move the mechanism from a first position (where the auto-syringe 10 is not activated) to a second position (where the auto-syringe 10 is activated). After the mechanism has moved from the first position to the second position, if the auto-syringe 10 is subsequently removed from the device 100, the connector 45 is decoupled from the auto-syringe 10. This allows the auto-syringe 10 to be completely removed from the device 100.

[0065] Figures 5A to 5C show device 100 and automatic syringe 10 according to several embodiments of the present invention.

[0066] Figure 5A shows multiple blister packs 50. Each blister pack contains one sealed auto-syringe 10. By sealing the auto-syringe 10 within each individual blister pack 50, the sterility of the auto-syringe 10 can be maintained until the time of use.

[0067] Figure 5A shows multiple blister packs 50 that are joined together, with each blister pack 50 defined by perforations 52. A single blister pack 50 can be separated from the rest of the blister packs by tearing along the perforations 52. Alternatively, the individual blister packs 50 may be completely separate (i.e., not joined together).

[0068] Figure 5B shows multiple blister packs 50 of Figure 5A housed in a box or container 54 of the device 100. The blister packs 50 (and thus the auto-injectors 10) can be arranged in a variety of ways within the box, including being arranged horizontally or vertically, front to back or side to side, in a coiled manner (similar to Figure 5B), or in a disordered manner (as shown in Figure 5B).

[0069] Device 100 includes a dispenser 56 positioned to dispense auto-syringes 10 in blister packs 50 within a box 54. Figure 5B shows the dispenser 56 as an aperture through which only one auto-syringe 10 at a time is drawn out of the box 54. Figure 5C is another diagram of device 100 from Figure 5B, showing the dispenser 56 and the auto-syringes 10 being dispensed.

[0070] A blister pack 50, as shown in Figures 5A to 5C, may include a tab-like connector 45 that connects the blister pack 50 to the auto-syringe 10. The connector 45 is configured to decouple from the auto-syringe 10 and activate the auto-syringe 10. The connector operates as previously described with respect to Figure 4.

[0071] Figure 5C is an isometric view of the device 100 in Figure 5B. The drawing shows a dispenser 56 that is sized in such a way that, in this case, more than one automatic syringe 10 cannot be taken out of the box 54 at the same time. Thus, the dispenser 56 is configured to prevent two or more automatic syringes 10 from being taken out of the device 100 at the same time. When multiple blister packs 50 are linked together as shown in Figure 5A, the removal of one blister pack 50 from the box 54 via the dispenser 56 pulls the next blister pack 50 toward the dispenser 56, preparing it for the next removal.

[0072] In some examples, the device 100 is configured to activate the auto-syringe 10 by at least partially opening the blister pack 50 containing the auto-syringe 10. The device 100 may include an opening mechanism, such as a sharp projection, positioned to partially open or tear the blister pack 50 when the auto-syringe 10 in the blister pack is removed from the device 100. When the device 100 includes a container 54 as shown in Figure 5C, the opening mechanism is included near the dispenser 56.

[0073] According to some examples, device 100 may include a locking mechanism. The locking mechanism can move between a locked state that prevents the removal of at least one auto-injector 10 from device 100 and an unlocked state that allows the removal of at least one auto-injector 10 from device 100. The locking mechanism is moved from the locked state to the unlocked state by a key housed in or on device 100. The user uses this key to move the locking mechanism from the locked state to the unlocked state, thereby removing the auto-injector 10 from device 100. The locking mechanism may include a mechanical or electronic lock.

[0074] Device 100 may include multiple locking mechanisms and multiple keys, each corresponding to a separate automatic syringe 10. Each key may correspond to a separate locking mechanism, such that only a specific key can move that locking mechanism from a locked state to an unlocked state. Thus, each key can unlock only a specific automatic syringe 10 from device 100, thereby allowing that automatic syringe to be removed from device 100. The locking mechanisms and keys act as an anti-tampering feature, such that only a specific automatic syringe 10 is activated by a specific removal from a specific locking mechanism. Device 100 may also be configured to release the locks in response to an authentication input, such as by entering an authentication code into circuit 30. Device 100 may include multiple containers 54, each container 54 containing its own locking mechanism and housing its own automatic syringe 10. The user can only open a specific container 54 and remove a specific automatic syringe 10 with a specific key.

[0075] Figure 6A shows device 100 according to one embodiment of the present invention. Figure 6B shows a cross-section of device 100 in Figure 6A.

[0076] Figures 6A and 6B show a device 100 that includes a box 54 configured to house an automatic syringe 10. Similar to Figures 5B and 5C, the device 100 includes a dispenser 56 positioned to dispense the automatic syringe 10 housed in the box 54.

[0077] The dispenser 56 can be configured to prevent more than one auto-syringe 10 from being dispensed from the device 100 at the same time. In other words, the dispenser 56 can be configured so that only one auto-syringe 10 can be dispensed from the device 100 at a time by the user.

[0078] Figures 6A and 6B show a dispenser 56 including a drawer 57 located on the surface 58 of a box 54. The drawer 57 can move between an open position, as shown in Figure 6B, and a closed position, as shown in Figure 6A.

[0079] When drawer 57 is in the closed position, removal of the auto-syringe 10 from device 100 is prevented. When drawer 57 is in the open position, the user can remove the auto-syringe 10 from device 100 through drawer 57. As shown in Figure 6B, the leftmost auto-syringe 10 is ready for removal by the user from device 100. Removal of the remaining auto-syringes 10 from device 100 is prevented by drawer 57. Drawer 57 is made to be able to move by a fixed distance so that only a single auto-syringe 10 can be provided to the user for removal. A first elastic member 59 (such as a spring) is connected to drawer 57 and box 54 and can bias the drawer from the open position to the closed position.

[0080] The drawer 57 may further include a second elastic member 60 configured to apply a biasing force to a plurality of auto-syringes 10 housed in the drawer 57, so that when one auto-syringe 10 is removed from the drawer 57, another auto-syringe 10 of the plurality of auto-syringes 10 is pushed forward in the drawer, ready for removal by the user.

[0081] Device 100 may include a display 61 that shows the number of auto-syringes 10 stored in the box 54. Figure 6A shows a display 61 which is an electronic display including multiple LEDs 62, but an electronic display including an LCD may be used instead. The display is updated based on an electronic system including a photosensor that monitors the number of auto-syringes 10 stored in the box 54. Alternatively, the display 61 may be a mechanical display which is updated based on a mechanical counting wheel that monitors the number of auto-syringes 10 stored in the box 54. Or, or in addition, the box 54 may include a window (not shown) in which the user can see the number of auto-syringes 10 contained therein.

[0082] Each automatic syringe 10 is activated in response to being removed from the drawer 57. In some examples, the drawer 57 can be configured to remove a part of the automatic syringe 10 when it is removed from the drawer 57. For example, the drawer 57 can be configured to remove the cap 12 of the automatic syringe 10 when it is removed from the drawer 57. The drawer 57 may include coupling means arranged to connect to the cap 12 of the automatic syringe 10. The cap 12 may remain in the drawer 57 after the automatic syringe 10 has been removed.

[0083] Figure 7A is a schematic diagram of a circuit 70 included in device 100 according to several embodiments of the present invention. The circuit 70 includes a control unit 72, a sensor 74, and an actuator 76. The sensor 74 and actuator 76 are electrically coupled to the control unit 72. The control unit 72 can control the operation of the sensor 74 and actuator 76.

[0084] Sensor 74 is configured to sense whether the automatic syringe 10 is activated and to send a corresponding signal to the control unit 72 indicating whether the automatic syringe 10 is activated or not. Sensor 74 can be a mechanical sensor such as a switch that is activated only by a specific configuration of the automatic syringe 10, or an electronic sensor such as an optical sensor, RFID sensor, or Hall sensor. The control unit 72 is configured to determine whether the automatic syringe 10 is activated based on the signal received from sensor 74.

[0085] Actuator 76 is an electric actuator, such as a motor or solenoid, controlled by control unit 72. Actuator 76 can move between a first position and a second position. Actuator 76 is positioned within device 100 such that in the first position, it can house the automatic syringe 10 sensed by sensor 74 into device 100, and in the second position, it prevents the same automatic syringe 10 from being housed in device 100. Control unit 72 can send signals to actuator 76 to move it from the first position to the second position or vice versa.

[0086] The control unit 72 is configured to send a signal to the actuator 76 to move it from a first position to a second position in response to determining that the automatic syringe 10 has been activated based on the signal received from the sensor 74. As a result, the activated automatic syringe 10, as detected by the sensor 74, is prevented from being stored in the device 100. This has the advantage of preventing the user from attempting to return and restore an activated automatic syringe 10 (which has already been removed from the device 100) back into the device 100. Consequently, the user is prompted to use that particular automatic syringe 10 before taking out other automatic syringes.

[0087] Figure 7B shows one embodiment of the present invention. The device 100 includes a box 54 for housing a plurality of auto-syringes 10 (not shown). In this embodiment, the device 100 includes a plurality of apertures 77 arranged on the surface 58 of the box 54. Each aperture 77 is configured to house a respective auto-syringe 10. In the example shown in Figure 7B, the device 100 has five apertures 77 and can therefore house five auto-syringes 10, but the present invention is not limited to this number, and more or fewer auto-syringes 10 can be housed in the device 100.

[0088] The device 100 in Figure 7B may include a circuit 70 as described with reference to Figure 7A. Figure 7B shows sensors 74 positioned in close proximity to each aperture 77. Each sensor 74 is electrically coupled to a control unit 72 (not shown). Each sensor 74 is configured to sense whether an auto-injector 10 approaching the vicinity of the corresponding aperture 77 is activated. The device 100 further includes a plurality of actuators 76, each electrically coupled to the control unit 72. Each aperture 77 has an actuator 76 positioned in close proximity to the aperture 77. When each actuator 76 is positioned in close proximity to its respective aperture 77, the auto-injector 10 is housed in its respective aperture 77 when the actuator 76 is in a first position, and the auto-injector 10 is prevented from being housed in its respective aperture 77 when the actuator 76 is in a second position. The leftmost actuator 76 is in the first position, and the first actuator 76 to the right of the leftmost actuator is in the second position.

[0089] Next, we will describe the operation of device 100 shown in Figure 7B.

[0090] An unactivated auto-syringe 10 is housed in aperture 77 of device 100. The user removes the auto-syringe 10 from device 100 by pulling it out of aperture 77. In response to the removal of the auto-syringe 10 from device 100, device 100 automatically activates the auto-syringe 10. The user attempts to place the activated auto-syringe 10 into the same aperture 77 (or possibly another aperture 77) of device 100. As the user brings the auto-syringe 10 closer to aperture 77, the auto-syringe 10 approaches a sensor 74 located near aperture 77. The sensor 74 detects that the auto-syringe 10 is activated and sends a corresponding signal to the control unit 72. In response to the control unit 72 determining from the signal that the automatic syringe 10 has been activated, the control unit 72 sends a signal to the actuator 76 adjacent to the aperture 77 and moves it from the first position to the second position. While the actuator 76 is in the second position, the automatic syringe 10 is prevented from being stored in the aperture 77.

[0091] Figure 7B shows that the device 100 may further include a shelf 79 configured to house activated auto-syringes 10. The shelf 79 is located on the surface of the box 54. A user can take an auto-syringe 10 out of the device 100, thereby activating it, but may want to use the auto-syringe 10 after some time has passed. As mentioned earlier, the user is prevented from storing the activated auto-syringe 10 back into the device 100. Therefore, the shelf 79 provides the user with a convenient place to store the activated auto-syringe 10 until it is ready for use. The user is encouraged to use the activated auto-syringe 10 stored on this shelf before activating a new auto-syringe 10 stored elsewhere in the device 100.

[0092] The present invention further relates to a system comprising a device 100 according to any of the embodiments described above, and an auto-injector 10, including but not limited to those described above. The auto-injector 10 of the system is configured to be activated by the device 100 in response to being removed from the device 100.

[0093] Figure 8 shows an automatic syringe 10 suitable for use in the system of the present invention.

[0094] The system may include a start indicator 80 configured to show the user that the automatic syringe 10 is activated. Figure 8 shows the automatic syringe 10 including the start indicator 80. In this case, the start indicator 80 includes an LED, but may also include a display or a speaker in addition to or alternatively to that. In other embodiments, device 100 may include the start indicator 80.

[0095] Figure 9 is a cross-sectional view of an automatic syringe storage device 100 according to several embodiments of the present invention. Device 100 is similar to device 100 shown in Figures 6A and 6B.

[0096] The device 100 may include a mounting mechanism 95 positioned to connect the box 54 to one or more racks 90 of a refrigerator. The refrigerator is configured to cool the automatic syringes 10 housed in the device 100 once the device 100 is connected to the racks 90. In the example shown in Figure 9, the refrigerator includes upper and lower racks 90. The mounting mechanism 95 includes a recess configured to receive at least a portion of the racks 90.

[0097] The system in Figure 9 further includes a temperature indicator 98 configured to show the user the temperature of the auto-syringe 10. The temperature indicator 98 is activated when the auto-syringe 10 is removed from the device 100.

[0098] To slow down the breakdown of a drug, it is often necessary to cool the drug to below room temperature. However, it may be necessary or preferable to raise the temperature of the drug to a temperature higher than the cooling temperature before injection. For example, it may be necessary or preferable for the drug to reach room temperature before injection.

[0099] The temperature indicator 98 in Figure 9 is entirely contained within the auto-injector 10, but the temperature indicator 98 may, alternatively, be contained within any part of the system. The temperature indicator 98 may include a thermometer coupled to an LED (not shown). The temperature indicator 98 is activated when the cooled auto-injector 10 is removed from the device 100. The temperature indicator 98 monitors the temperature of the auto-injector 10, such as the temperature of the medication contained within the auto-injector 10. The temperature is monitored using a thermometer. The temperature indicator 98 shows the temperature to the user. The temperature is continuously monitored and shown to the user. Alternatively, the temperature may be shown to the user when it reaches a temperature threshold, such as a temperature suitable for injection. The user may be indicated that the temperature threshold has been reached by the LED lighting up (or turning off or flashing).

[0100] While the claims in this application are formulated to suit specific combinations of configurations, the scope of this disclosure also includes any novel configurations or combinations of configurations, or any generalizations thereof, that are expressly or implicitly disclosed herein, regardless of whether they relate to the same invention claimed in any of the claims herein, or whether they mitigate some or all of the same technical problems as the present invention. The applicant hereby notes that new claims may be formulated during the examination process of this application or any further application derived therefrom, to suit such configurations and / or combinations of configurations.

[0101] Although several embodiments have been illustrated and described, those skilled in the art will understand that these embodiments can be modified without departing from the principles of the present invention, and that the scope of the present invention is defined in the claims.

[0102] The terms “drug” or “pharmaceutical” are used herein as synonyms and refer to a pharmaceutical preparation comprising one or more pharmacokinetic active ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. A pharmacokinetic active ingredient ("API") is, in its broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or pharmaceuticals are used to treat, cure, prevent or diagnose a disease, or, separately, to improve physical or mental health. Drugs or pharmaceuticals are used for a limited duration or, in the case of chronic diseases, regularly.

[0103] As described below, a drug or pharmaceutical may contain at least one API, or a combination thereof, of various types of formulations for treating 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 are incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also conceived.

[0104] The term “drug delivery device” encompasses, but is not limited to, any type of device or system configured to administer drugs or medications into the body of a human or animal. Drug delivery devices can include, but are not limited to, injection devices (e.g., syringes, pen injectors, autoinjectors, high-volume devices, pumps, perfusion systems, or other devices configured for intraocular, subcutaneous, intramuscular, or intravascular delivery), skin patches (e.g., osmotic, chemical, or microneedle), inhalers (e.g., nasal or pulmonary), implantable devices (e.g., drug or API-coated stents, capsules), or delivery systems for the gastrointestinal tract. Drugs described herein may be particularly useful in injection devices, such as subcutaneous needles, having, for example, a gauge number of 24 or more.

[0105] Drugs or pharmaceuticals are contained within a main package or “drug container” applied for use with a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other solid or flexible container configured to provide a chamber suitable for the storage of one or more drugs (e.g., short-term or long-term storage). For example, the chamber may be designed to hold a drug for at least one day (e.g., from one day to at least 30 days). The chamber may be designed to store a drug for approximately one month to approximately two years. Storage can be carried out at room temperature (e.g., approximately 20°C) or refrigerated temperature (e.g., from approximately -4°C to approximately 4°C). The drug container may be, or may include, a dual-chamber cartridge configured to store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different types of drugs) separately, one in each chamber. In such cases, the two chambers of the dual-chamber cartridge are configured to allow mixing of the two or more components before and / or during administration into the body of a human or animal. For example, two chambers may be configured to be fluidly connected to each other (e.g., by a conduit between the two chambers) and, if desired, allow the user to mix the two components before administration. Alternatively, or in addition to this, the two chambers may be configured to allow the components to be mixed when they are being administered into the body of a human or animal.

[0106] The drugs or agents contained within the drug delivery devices described herein are used to treat and / or prevent a number of different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes such as diabetic retinopathy, and thromboembolic disorders such as deep vein thromboembolism or pulmonary thromboembolism. Other examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs include, but are not limited to, those listed in the Handbook's Rote Liste 2014, main group 12 (antidiabetic drugs) or main group 86 (oncology drugs), and the Merck Index, 15th edition.

[0107] 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 human insulin analogs or derivatives; glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or their analogs or derivatives; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof, or any mixture thereof. As used herein, the terms “analog” and “derivative” refer to any substance that is structurally similar enough to the original substance that it can thereby have similar function or activity (e.g., therapeutic effect). In particular, the term “analog” refers to a polypeptide having a molecular structure obtained by deleting and / or replacing at least one amino acid residue found in a natural peptide, e.g., human insulin, and / or adding at least one amino acid residue. The amino acid residues added and / or replaced may be coding amino acid residues, other native residues, or entirely 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 derived formulaically from the structure of a native peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are bonded to one or more amino acids. In some cases, one or more amino acids found in the native peptide may be deleted and / or substituted with other amino acids, including non-coding amino acids, or amino acids, including non-coding amino acids, may be added to the native peptide.

[0108] Examples of insulin analogs include 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 proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and Lys at position B29 is replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin; and Des(B30) human insulin.

[0109] Examples of insulin derivatives include, 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 These include B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-ω-carboxyheptadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®), B29-N-(N-litocoryl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin; and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0110] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (excendin-4, Dyetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r-excendin-4, CJC-1134-PC, PB-1023, TTP-054, ra These include ngrenatide / HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-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.

[0111] An example of an oligonucleotide is mipomersen sodium (Kynamro®), a cholesterol-lowering antisense drug used to treat familial hypercholesterolemia.

[0112] Examples of DPP4 inhibitors include vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0113] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, choriongonadotropin, menotropin), somatropins (somatropin), desmopressin, terlipressin, gonadrelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0114] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or very low molecular weight heparin, or their derivatives, or sulfated forms of the above polysaccharides, such as polysulfated forms, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include Hylan G-F20 (Synvisc®) and sodium hyaluronate.

[0115] As used herein, the term “antibody” refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal, monoclonal, recombinant, chimeric, non-immune or humanized, fully human, non-human (e.g., mouse), or single-chain antibodies. In some embodiments, antibodies may have effector function and may be able to immobilize complement. In some embodiments, antibodies may have a low ability to bind to or be unable to bind to Fc receptors. For example, antibodies may be isotypes or subtypes, antibody fragments or variants that do not support binding to Fc receptors and have, for example, mutated or deleted Fc receptor-binding regions. The term “antibody” also includes antibody-binding molecules based on tetravalent bispecific tandem immunoglobulin (TBTI) and / or bivariable region antibody-like binding proteins (CODV) with orientation of cross-binding regions.

[0116] The term “fragment” or “antibody fragment” refers to a polypeptide derived from an antibody polypeptide molecule (e.g., antibody heavy and / or light chain polypeptide) that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may include cleaved portions of the full-length antibody polypeptide, but the term is not limited to such cleaved 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 antibody fragments, or multispecific antibody fragments such as bispecific, trispecific, quadrispecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent antibody fragments, or multivalent antibody fragments such as bivalent, trivalent, quadrivalent and polyvalent antibodies, minibodies, chelated recombinant antibodies, tribodies or vibodies, intrabodies, nanobodies, small modular immunoassays (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Further examples of antigen-binding antibody fragments are known in the art.

[0117] The term “complementarity-determining region” or “CDR” refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term “framework region” refers not to the CDR sequence itself, but to the amino acid sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for maintaining the correct positioning of the CDR sequence and enabling antigen binding. While the framework region itself is not typically directly involved in antigen binding, as is commonly known in the art, specific residues within the framework region of a particular antibody may be directly involved in antigen binding, or one or more amino acids within the CDR may influence the ability to interact with the antigen.

[0118] Examples of antibodies include anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0119] pharmaceutically acceptable salts of any API described herein are also intended for use in drug delivery devices. pharmaceutically acceptable salts include, for example, acid addition salts and basic salts.

[0120] Modifications (additions and / or deletions) of various components of the APIs, formulations, apparatus, methods, systems, and embodiments described herein can be made without departing from the full scope and spirit of the invention, and it will be understood by those skilled in the art that the invention encompasses all such modifications and all equivalents of the invention.

Claims

1. A storage device for storing a plurality of auto-injectors, the storage device being configured to activate an auto-injector when the auto-injector is removed from the device.

2. 10. The device of claim 1, configured to activate the auto-injector by at least partially opening a blister pack containing the auto-injector.

3. 3. The device of claim 1 or 2, configured to activate the auto-injector by modifying the auto-injector.

4. 4. The device of claim 3, configured to activate the auto-injector by interrupting or completing an electrical circuit of the auto-injector.

5. 5. The device of claim 3 or 4, configured to activate the auto-injector by removing a portion of the auto-injector.

6. 6. The device of any one of claims 1 to 5, comprising an auto-injector and a connector coupled to a surface of the device, wherein the connector is configured to decouple from the auto-injector and activate the auto-injector.

7. 7. The device of claim 6, comprising a blister pack configured to contain an auto-injector, wherein the connector is coupled to the blister pack and the auto-injector and configured to decouple from the auto-injector and activate the auto-injector.

8. 8. The device of any one of claims 1 to 7, comprising a box configured to contain the auto-injectors and a dispenser arranged to dispense the auto-injectors contained in the box, wherein the dispenser is configured to prevent simultaneous removal of more than one auto-injector from the device.

9. 9. The device of claim 8, wherein the dispenser includes a drawer movable between an open position and a closed position, and the automatic injector can be removed from the device via the drawer when in the open position.

10. 10. A device according to any one of claims 1 to 9, configured to prevent subsequent storage of the auto-injector within the device after the auto-injector has been removed from the device and activated.

11. 11. The device of claim 10, configured to activate the auto-injector by changing the geometry of the auto-injector from a first state to a second state, configured to store the auto-injector when in the first state, and further configured to prevent storage of the auto-injector within the device when the auto-injector is in the second state.

12. a control unit; a sensor coupled to the control unit; an actuator coupled to the control unit; Including, Here, the control unit: determining whether the auto-injector is activated based on a signal from the sensor; configured, in response to determining that the auto-injector has been activated, to send a signal to the actuator to move the actuator from a first position that allows the auto-injector to be stored within the device to a second position that prevents the auto-injector from being stored within the device; The device of claim 10.

13. 13. A system comprising a device according to any one of claims 1 to 12 and a plurality of auto-injectors containing a medicament.

14. 14. The system of claim 13, further comprising an activation indicator configured to indicate to a user that the auto-injector has been activated.

15. 15. The system of claim 13 or 14, comprising a temperature indicator configured to indicate the temperature of the automatic injector to a user, wherein the temperature indicator is activated when the automatic injector is removed from the device.

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