Drug delivery device having a needle carrier

Abstract

A drug delivery device is provided having a needle assembly portion and a drug device portion, the needle assembly portion being removably coupleable to the drug device portion. In some embodiments, the needle of the needle assembly can be movable from a retracted position to an extended position for penetrating into the skin of a subject. In some embodiments, the needle can also be movable back to the retracted position.

Description

[Background technology]

[0001] Patients suffering from many different diseases must frequently inject themselves with medication. To enable individuals to conveniently and accurately self-administer medication, various devices, commonly known as syringe pens or injection pens, have been developed. These pens are typically loaded with a medication container, such as a cartridge containing a piston and containing multiple doses of liquid medication. The drive member, which protrudes from within the base of the syringe pen and is operably connected to the pen's mechanism controlling the movement of the drive member, is typically movable forward to advance the piston within the cartridge, such as through a needle piercing a stopper at its opposite end and dispensing the contained medication from an outlet at the opposite cartridge end. In disposable or refillable pens, after the pen is used to deplete the supply of medication in the cartridge, the user discards the entire pen and then begins using a new, replacement pen. In reusable pens, after the pen is used to deplete the supply of medication in the cartridge, the pen can be disassembled to allow the used cartridge to be replaced with a new cartridge, and the pen is then reassembled for subsequent use.

[0002] The inventors have understood that with some drug delivery devices, a user may need to attach and / or detach a needle from the drug delivery device before and / or after use. The inventors have recognized the need for an arrangement that facilitates the attachment and detachment of a needle assembly from a drug delivery device. Summary of the Invention

[0003] According to one aspect, a drug delivery device is provided. The drug delivery device, in some embodiments, may include a needle assembly including a needle carrier, a needle hub movable relative to the needle carrier, and a needle coupled to the needle hub. The drug delivery device may also include a drug device having a septum and a carrier drive element disposed at the container end opening. The needle carrier may be coupleable to the drug device. A deployment trigger may be configured to actuate the carrier drive element to move the needle hub distally from a retracted needle hub position to an ejected needle hub position and to move the needle distally relative to the septum from a retracted needle position to an ejected needle position.

[0004] According to another aspect, a method is provided. The method, in some embodiments, may include providing a medication device having a container with a septum disposed at the container end opening and a carrier drive element, and providing a needle assembly including a needle carrier, a needle hub movable relative to the needle carrier, and a needle coupled to the needle hub. When the needle carrier is coupled to the medication device, the method may further include actuating a deployment trigger to actuate the carrier drive element to move the needle hub distally from a retracted needle hub position to an ejected needle hub position and to move the needle from the retracted needle position to the ejected needle position relative to the septum.

[0005] According to yet another aspect, a needle assembly for coupling to a drug device having a container with a spring and a septum containing a fluid is provided. In some embodiments, the needle assembly may include a needle carrier removably coupleable to the drug device to load the spring, a needle hub movable relative to the needle carrier, and a needle coupled to the needle hub. Coupling the needle carrier to the drug device facilitates piercing the septum of the drug device with the needle. The needle hub is movable distally relative to the needle carrier to position the distal end of the needle to extend beyond the needle carrier and the proximal end of the needle to reside within the septum in fluid communication with the fluid in the container.

[0006] Other advantages and novel features of the present invention will become apparent from the following detailed description of various non-limiting embodiments of the invention when considered in conjunction with the accompanying figures. In the event that the present specification and a document incorporated by reference include conflicting and / or inconsistent disclosure, the present specification shall control. In the event that two or more documents incorporated by reference include conflicting and / or inconsistent disclosure with respect to each other, the document having the later effective date shall control. [Brief explanation of the drawings]

[0007] Further embodiments of the present disclosure, and its features and advantages, will become more apparent by reference to the description herein in conjunction with the accompanying drawings, in which elements are not necessarily drawn to scale. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the different views.

[0008] [Figure 1A] 1A-1C show a series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device and the needle is moved in a protrusion direction. [Figure 1B] 1A-1C show a series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device and the needle is moved in a protrusion direction. [Figure 1C] 1A-1C show a series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device and the needle is moved in a protrusion direction. [Figure 1D] 1A-1C show a series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device and the needle is moved in a protrusion direction. [Figure 1E] 1A-1C show a series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device and the needle is moved in a protrusion direction. [Figure 2A]A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protrusion direction to pierce the skin of a subject, and the needle assembly is removed from the drug device. [Figure 2B] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protrusion direction to pierce the skin of a subject, and the needle assembly is removed from the drug device. [Figure 2C] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protrusion direction to pierce the skin of a subject, and the needle assembly is removed from the drug device. [Figure 2D] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protrusion direction to pierce the skin of a subject, and the needle assembly is removed from the drug device. [Figure 2E] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protrusion direction to pierce the skin of a subject, and the needle assembly is removed from the drug device. [Figure 2F] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protrusion direction to pierce the skin of a subject, and the needle assembly is removed from the drug device. [Figure 2G] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protrusion direction to pierce the skin of a subject, and the needle assembly is removed from the drug device. [Figure 2H] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protrusion direction to pierce the skin of a subject, and the needle assembly is removed from the drug device. [Figure 2I]A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protrusion direction to pierce the skin of a subject, and the needle assembly is removed from the drug device. [Figure 2J] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protrusion direction to pierce the skin of a subject, and the needle assembly is removed from the drug device. [Figure 3] 1 shows a schematic diagram of a drug device and multiple needle assemblies each contained within an individual container. [Figure 4A] 10 shows a series of needle assembly steps in which the needle starts in a retracted position, is moved to an extended position, and is coupled to a container for removal from the medication device. [Figure 4B] 10 shows a series of needle assembly steps in which the needle starts in a retracted position, is moved to an extended position, and is coupled to a container for removal from the medication device. [Figure 4C] 10 shows a series of needle assembly steps in which the needle starts in a retracted position, is moved to an extended position, and is coupled to a container for removal from the medication device. [Figure 5] FIG. 1 is an exploded view of a drug delivery device according to one embodiment. [Figure 6A] FIG. 1 is a perspective view of a needle assembly prepared for use with a drug device, the needle assembly being held within a container and a peel tab sealing the needle assembly within the container. [Figure 6B] FIG. 6C is a perspective view of the container of FIG. 6B with the peel tab removed from the container. [Figure 6C] 6C shows the container of FIG. 6B coupled to a drug device. [Figure 6D] 6D shows the container of FIG. 6C removed from the drug device, with the needle assembly still attached to the drug device. [Figure 6E] The needle assembly is shown as a trigger being pushed proximally to actuate extension of the needle of the needle assembly. [Figure 6F] Figure 6E shows the needle moved to the ejection position. [Figure 7A] 10 shows a container coupled to a needle assembly for removing the needle assembly from a medication device. [Figure 7B] 10 shows the container being manipulated to remove the needle assembly from the medication device. [Figure 8A] FIG. 10 shows a detailed view of the carrier of the needle assembly in the process of being coupled to the first part of the medication device. [Figure 8B] 8B shows the carrier of FIG. 8A coupled to a first portion of a drug device. [Figure 9A] 8B shows the carrier of FIG. 8A in the process of being removed from the first portion of the medication device. [Figure 9B] 8B shows the carrier of FIG. 8A in the process of being removed from the first portion of the medication device. [Figure 9C] 8B shows the carrier of FIG. 8A in the process of being removed from the first portion of the medication device. [Figure 10A] FIG. 1 shows a cross-sectional view of a needle assembly coupled to a first portion of a drug device. [Figure 10B] FIG. 1 shows a cross-sectional view of a needle assembly coupled to a first portion of a drug device. [Figure 10C] FIG. 1 shows a cross-sectional view of a needle assembly coupled to a first portion of a drug device. [Figure 10D] 10B shows the trigger of the needle assembly of FIG. 10A being pressed against the skin of a subject to actuate needle ejection. [Figure 10E] 10D illustrates the extension of the needle of FIG. 10D into the skin of a subject. [Figure 10F] 10 illustrates the removal of the needle assembly from the medication device using the container body. [Figure 11A] 1 shows a diagram of a needle carrier according to one embodiment. [Figure 11B] 1 shows a diagram of a needle carrier according to one embodiment. [Figure 11C] 1 shows a diagram of a needle carrier according to one embodiment. [Figure 11D]1 shows a diagram of a needle carrier according to one embodiment. [Figure 11E] 1 shows a diagram of a needle carrier according to one embodiment. [Figure 11F] 1 shows a diagram of a needle carrier according to one embodiment. [Figure 12A] 1 shows a diagram of a first portion of a drug device according to one embodiment. [Figure 12B] 1 shows a diagram of a first portion of a drug device according to one embodiment. [Figure 12C] 1 shows a diagram of a first portion of a drug device according to one embodiment. [Figure 12D] 1 shows a diagram of a first portion of a drug device according to one embodiment. [Figure 12E] 1 shows a diagram of a first portion of a drug device according to one embodiment. [Figure 13A] 1A and 1B show views of a needle hub according to one embodiment. [Figure 13B] 1A and 1B show views of a needle hub according to one embodiment. [Figure 13C] 1A and 1B show views of a needle hub according to one embodiment. [Figure 13D] 1A and 1B show views of a needle hub according to one embodiment. [Figure 13E] 1A and 1B show views of a needle hub according to one embodiment. [Figure 14A] 1 shows a diagram of a trigger according to one embodiment. [Figure 14B] 1 shows a diagram of a trigger according to one embodiment. [Figure 14C] 1 shows a diagram of a trigger according to one embodiment. [Figure 14D] 1 shows a diagram of a trigger according to one embodiment. [Figure 14E] 1 shows a diagram of a trigger according to one embodiment. [Figure 14F] 1 shows a diagram of a trigger according to one embodiment. [Figure 15A] 1 shows a view of a container according to one embodiment. [Figure 15B] 1 shows a view of a container according to one embodiment. [Figure 15C] 1 shows a view of a container according to one embodiment. [Figure 15D]1 shows a view of a container according to one embodiment. [Figure 15E] 1 shows a view of a container according to one embodiment. [Figure 15F] 1 shows a view of a container according to one embodiment. [Figure 16A] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protruding direction to pierce the skin of a subject, the needle is moved in a retracting direction, and the needle assembly is removed from the drug device. [Figure 16B] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protruding direction to pierce the skin of a subject, the needle is moved in a retracting direction, and the needle assembly is removed from the drug device. [Figure 16C] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protruding direction to pierce the skin of a subject, the needle is moved in a retracting direction, and the needle assembly is removed from the drug device. [Figure 16D] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protruding direction to pierce the skin of a subject, the needle is moved in a retracting direction, and the needle assembly is removed from the drug device. [Figure 16E] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protruding direction to pierce the skin of a subject, the needle is moved in a retracting direction, and the needle assembly is removed from the drug device. [Figure 16F] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protruding direction to pierce the skin of a subject, the needle is moved in a retracting direction, and the needle assembly is removed from the drug device. [Figure 16G]A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protruding direction to pierce the skin of a subject, the needle is moved in a retracting direction, and the needle assembly is removed from the drug device. [Figure 16H] A series of schematic diagrams of a drug delivery device according to one embodiment going through a series of steps in which a needle assembly is attached to the drug device, the needle is moved in a protruding direction to pierce the skin of a subject, the needle is moved in a retracting direction, and the needle assembly is removed from the drug device. [Figure 17] FIG. 1 is an exploded view of a drug delivery device according to one embodiment. [Figure 18A] FIG. 1 is a perspective view of a needle assembly and a drug device prepared for use with the drug device. [Figure 18B] FIG. 18B is a perspective view of the needle assembly and drug device of FIG. 18A with the peel-away tab removed. [Figure 18C] FIG. 18C is a perspective view of the needle assembly and drug device of FIG. 18B, with the collar of the drug device rotated to receive the needle assembly. [Figure 18D] FIG. 18D is a perspective view of the needle assembly and drug device of FIG. 18C, with the needle assembly coupled to the drug device. [Figure 18E] FIG. 18E is a perspective view of the needle assembly and drug device of FIG. 18D, with the needle assembly coupled to the drug device. [Figure 18F] FIG. 18F is a perspective view of the needle assembly and medication device of FIG. 18E, with the needle of the needle assembly in an extended position. [Figure 18G] FIG. 18F is a perspective view of the needle assembly and medication device of FIG. 18E, with the needle in a retracted position. [Figure 19] FIG. 18H is a perspective view of the needle assembly and medication device of FIG. 18G, with the needle assembly removed from the medication device. [Figure 20A] 1 shows a cross-sectional view of a needle assembly coupled to a drug device. [Figure 20B] 1 shows a cross-sectional view of a needle assembly coupled to a drug device. [Figure 20C]1 shows a cross-sectional view of a needle assembly coupled to a drug device. [Figure 20D] 1 shows a cross-sectional view of a needle assembly coupled to a drug device. [Figure 20E] 1 shows a cross-sectional view of a needle assembly coupled to a drug device. [Figure 20F] 1 shows a cross-sectional view of a needle assembly coupled to a drug device. [Figure 21A] 20B shows a cross-sectional view of the needle assembly of FIG. 20A being removed from the drug device. [Figure 21B] 20B shows a cross-sectional view of the needle assembly of FIG. 20A being removed from the drug device. [Figure 22A] 1A-1C show two perspective views of the collar in an inactivated state prior to use. [Figure 22B] 1A-1C show two perspective views of the collar in an inactivated state prior to use. [Figure 23A] 1 shows two perspective views of the collar after it has been rotated into an operative state. [Figure 23B] 1 shows two perspective views of the collar after it has been rotated into an operative state. [Figure 24A] 10A-10C show two perspective views of the collar after the needle has been moved to the ejection position. [Figure 24B] 10A-10C show two perspective views of the collar after the needle has been moved to the ejection position. [Figure 25A] 10A-10C show two perspective views of the collar after the needle has been moved to the retracted position. [Figure 25B] 10A-10C show two perspective views of the collar after the needle has been moved to the retracted position. [Figure 26A] 10A-10C illustrate the cam placement of the needle assembly as the drug delivery device goes through a series of needle ejection steps. [Figure 26B] 10A-10C illustrate the cam placement of the needle assembly as the drug delivery device goes through a series of needle ejection steps. [Figure 26C] 10A-10C illustrate the cam placement of the needle assembly as the drug delivery device goes through a series of needle ejection steps. [Figure 27A]10A-10C illustrate the placement of the needle carrier as the drug delivery device undergoes a series of needle retraction steps. [Figure 27B] 10A-10C illustrate the placement of the needle carrier as the drug delivery device undergoes a series of needle retraction steps. [Figure 28A] 1 shows a diagram of a needle carrier according to one embodiment. [Figure 28B] 1 shows a diagram of a needle carrier according to one embodiment. [Figure 28C] 1 shows a diagram of a needle carrier according to one embodiment. [Figure 28D] 1 shows a diagram of a needle carrier according to one embodiment. [Figure 28E] 1 shows a diagram of a needle carrier according to one embodiment. [Figure 28F] 1 shows a diagram of a needle carrier according to one embodiment. [Figure 29A] 1 shows a diagram of a cam according to one embodiment. [Figure 29B] 1 shows a diagram of a cam according to one embodiment. [Figure 29C] 1 shows a diagram of a cam according to one embodiment. [Figure 29D] 1 shows a diagram of a cam according to one embodiment. [Figure 29E] 1 shows a diagram of a cam according to one embodiment. [Figure 29F] 1 shows a diagram of a cam according to one embodiment. [Figure 30A] 1 shows a diagram of a hub according to one embodiment. [Figure 30B] 1 shows a diagram of a hub according to one embodiment. [Figure 30C] 1 shows a diagram of a hub according to one embodiment. [Figure 30D] 1 shows a diagram of a hub according to one embodiment. [Figure 31A] 1 illustrates a color diagram according to one embodiment. [Figure 31B] 1 illustrates a color diagram according to one embodiment. [Figure 31C] 1 illustrates a color diagram according to one embodiment. [Figure 31D] 1 illustrates a color diagram according to one embodiment. [Figure 31E]1 illustrates a color diagram according to one embodiment. [Figure 32A] 1A and 1B show views of portions of a drug device according to one embodiment. [Figure 32B] 1A and 1B show views of portions of a drug device according to one embodiment. [Figure 32C] 1A and 1B show views of portions of a drug device according to one embodiment. [Figure 32D] 1A and 1B show views of portions of a drug device according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0009] The present disclosure relates to a drug delivery device having a needle assembly removably attachable to another portion of the drug delivery device. This other portion of the drug delivery device is referred to herein as the drug device, and the combination of the needle assembly with the drug device is referred to herein as the drug delivery device. The drug device, in some embodiments, can include a portion of the drug delivery device that contains or is configured to contain a drug.

[0010] In one aspect, the needle assembly is configured to be attached to the medication device by a user without requiring the user to touch and / or see the needle of the needle assembly.

[0011] In one aspect, the needle assembly includes a needle handling container that can be used to attach the needle assembly to a device, which is then detached from the needle assembly for operation of the device, and then reused as a tool to remove the needle assembly from the device and store the used needle assembly.

[0012] In another aspect, the needle assembly is configured to be removed from the medication device by the user without requiring the user to touch the needle of the needle assembly, and in some embodiments, without the user having to see the needle of the needle assembly.

[0013] In another aspect, the needle assembly includes a needle handling container that is integrated with the needle assembly and can be used to attach the needle assembly to the device, remains with the needle assembly for operation of the device, and is then used as a tool to remove the needle assembly from the device and store the used needle assembly.

[0014] As discussed above, in some embodiments, the drug device portion of the drug delivery device may contain a drug. The term "drug" refers to one or more therapeutic agents, including, but not limited to, insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, and any therapeutic agent that can be delivered by the device. Drugs used in the device may be formulated with one or more excipients. The device is operated by a patient, a caregiver, or a medical professional in a manner generally as described above to deliver the drug to a person.

[0015] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same, it being understood, however, that no limitation on the scope of the invention is intended.

[0016] 1A-1E show a schematic diagram of a drug delivery device and a sequence of operation of an exemplary embodiment of the drug delivery device. The drug delivery device includes a needle assembly 1001 and a drug device 5001. In this embodiment, the needle assembly includes a needle carrier 201 and a needle 101 having a proximal end 121 and a distal end 141. The drug device 5001 includes a drug container 5301 and a mating end 5501 configured to be received by the needle carrier 201 of the needle assembly 1001.

[0017] In FIG. 1A , needle assembly 1001 is in the process of being coupled to coupling end 5501 of drug device 5001. Coupling end 5501 of drug device 5001 is inserted into the needle carrier, resulting in the arrangement shown in FIG. 1B , where drug device 5001 is coupled to needle carrier 201. As shown in the cross-sectional view of FIG. 1C , with drug device 5001 coupled to needle carrier 201, proximal end 121 of needle 101 penetrates septum 5201 of drug container 5301. As also shown in cross-section in FIG. 1C , drug container 5301 also includes interior 5321 and piston 5401 movable relative to interior 5321 and septum 5201. As will be appreciated by those skilled in the art, the piston may be moved by various piston drive actuators conventional in the art.

[0018] In the next step in the sequence shown in FIG. 1D , the needle 101 is moved to an extended position such that the distal end 141 of the needle extends a distance D beyond the distal end 241 of the needle carrier 201 to pierce the skin of the subject. As seen in FIG. 1E , the piston 5401 is then driven distally to expel the medicament from the interior 5321 of the medicament container 5301 through the needle 101 and into the subject. In some embodiments shown in FIG. 1E , the needle 101 may be movable to a retracted position in which the distal end 141 of the needle is moved to a position proximal to the distal end 241 of the needle carrier 201. However, in other embodiments, the needle remains in the extended position.

[0019] 2A-2J show a series of schematic diagrams of a drug delivery device according to one embodiment going through a series of operational steps.

[0020] As shown in FIG. 2A , the drug delivery device includes a needle assembly 100 and a drug device 500. In this exemplary embodiment, the needle assembly 100 is initially housed within a container 200 having a body 210 and a cover 220. The drug device may include a first portion 502 and a second portion 504. In some embodiments, the first portion 502 includes a coupling end 550 configured to couple with the needle assembly 100. In some embodiments, the first portion 502 of the drug device 500 may house a drug container. In some embodiments, the second portion 504 of the drug device 500 may include a device actuator. In some embodiments, actuation of the device actuator serves to release the drug from the drug container.

[0021] As a first step, the cover 220 is removed from the container body 210 to expose the needle assembly 100 located within the container 200. Next, the needle assembly 100 is coupled to the drug device 500. In some embodiments, with the needle assembly 100 positioned within the container body 210, a user couples the carrier 20 of the needle assembly 100 to the drug device 500 by holding the container body 210 and moving the container body toward the coupling tongue 550 of the drug device 500 until the needle assembly 100 contacts and couples with the drug device 500. As shown in FIG. 2B , the needle assembly 100 can remain within the container body 210 during coupling of the needle assembly 100 to the coupling end 550 of the drug device 500.

[0022] Thereafter, the container body 210 may be removed from the needle assembly 100 and the medication device 500, with the needle assembly carrier 20 still coupled to the medication device 500, as shown in FIG. 2C.

[0023] 2D, the drug delivery device may be primed to deliver a dose of medication by retracting actuator 590. However, it should be understood that the drug delivery device may utilize other types of actuators and delivery mechanisms that do not require retracting the actuator for dose delivery.

[0024] The drug delivery device is then placed against the subject's skin 5, as seen in FIG. 2E. In some embodiments, the needle assembly may include a trigger 30 that is positioned flush against the skin. The trigger structure may also be a shield around the needle 10 to visually hide the needle from the subject. In some embodiments, the trigger does not actually trigger needle ejection, but is a biased retraction shield, with triggering of needle ejection being performed by a separate actuation button or movement by the subject.

[0025] As shown in Figure 2F, to initiate piercing of the subject's skin, the user may depress the drug delivery device onto the user's skin, thus depressing the trigger 30 into the carrier 20 of the needle assembly, thereby actuating the piercing of the needle 10 from the carrier 20 and into the subject's skin 5. Next, as shown in Figure 2G, the user may depress the actuator 590 to expel the medication from the medication reservoir within the drug device through the needle 10, thereby injecting the medication into the subject.

[0026] As shown in FIG. 2H, after delivery of the agent to the subject, the drug delivery device is removed from the skin 5. As can be seen by review of the series of schematic diagrams, the trigger 30 may remain retracted within the carrier, although in other embodiments (not shown), the trigger 30 may be biased back to its extended position once the device is removed from the subject's skin. The user can then begin the process of removing the needle assembly from the drug device 500. In FIG. 2I, the user can push the container body 210 back onto the needle assembly to couple the needle assembly 100 to the container body 210.

[0027] As shown in Figure 2J, to remove the needle assembly from the drug device, a user can rotate the container body 210 relative to the drug device to unlock the needle assembly from the coupling end 550 of the drug device and then pull the container body 210 away from the drug device to remove the needle assembly from the drug device. As shown in Figures 2I and 2J, in some embodiments, the needle 10 remains in an extended position during removal of the needle assembly from the drug device. However, in other embodiments, the drug delivery device may include the ability to retract the needle before removing the needle assembly.

[0028] In some embodiments, the drug delivery device may be packaged as a kit including the drug device and multiple needle assemblies, each packaged in its own individual container. As seen in FIG. 3 , the kit may include a drug device 500 having a coupling end 550, an actuator 590, and a needle drive in the form of a drive spring 560. In some embodiments, the spring is a coil spring. In some embodiments, the spring is a torsion spring. In some embodiments, the spring is a leaf spring. In some embodiments, the spring is a Belleville washer. In some embodiments, the spring is a wave spring. In some embodiments, the actuator 590 may initiate the release of a drug from a drug container housed within the drug device 500. In some embodiments, the drive spring 560 may play a role in moving the needle of the needle assembly from a retracted position to an extended position, as discussed in more detail below. The multiple needle assemblies 100 may each be housed in an individually sealed container 200 having a container body 210 and a cover 220. In some embodiments, the cover 220 is a peelable seal that can be removably affixed to the container body via, for example, an adhesive. The cover may have a pull tab 222 to facilitate removal. However, other types of covers may be used, such as caps that engage with the container body via, for example, threads or other mechanical interlocks, or an interference fit. It should also be understood that a spring need not be used, but instead a motor, magnet, elastomeric compound, or any other device suitable as a carrier drive element capable of imparting motion may be used, as the disclosure is not limited in this respect.

[0029] 4A-4C show a series of needle assembly states as the drug delivery device goes through a series of steps. FIG. 4A shows the needle assembly 100 prior to actuation of the needle 10. The trigger 30 is in the extended position and the needle 10 is in the retracted position. In some embodiments, the needle assembly is positioned as shown in FIG. 4A when held within a container prior to being coupled to the drug device.

[0030] Figure 4B shows the needle assembly when needle 10 is moved to the extended position. As also shown in Figure 4B, trigger 30 is depressed into carrier 20 in the retracted position.

[0031] Finally, FIG. 4C shows the needle assembly being moved back into the container body 210 to remove it from the medication device.

[0032] An exploded view of an exemplary embodiment of a drug delivery device is shown in FIG. 5. The drug delivery device includes a needle assembly including a needle 10, a carrier 20, a trigger 30, and a needle hub 40. The needle assembly is initially housed within a container having a container body 210 and a cover 220. The container body 210 may include recesses 213 formed in the inner wall of the body 210 to receive fins 23 on the carrier 20 to allow the needle assembly to couple to the container body 210 when housed within the container body 210. Of course, it should be understood that fins may be formed in the inner wall of the body 210 and corresponding recesses may be formed in the carrier 20, as the disclosure is not limited in this respect. Detailed views of the carrier are provided in FIGS. 11A-11F. Detailed views of the container body 210 are provided in FIGS. 15A-15E.

[0033] The drug delivery device also includes a drug device including a first portion 502 and a second portion 504, which are represented schematically in Figure 5. In some embodiments, the first portion 502 of the drug device houses a drug container. In some embodiments, the second portion 504 of the drug device includes an actuator that, when actuated, causes the drug to be released from the drug container.

[0034] As will be discussed in detail, in some embodiments, the needle assembly couples to the drug device via a needle assembly carrier 20 that is physically interlocked with the drug device's coupling end 550. A drive spring 560 may be disposed within the coupling end 550.

[0035] 6A-6F illustrate a series of steps showing the coupling of a needle assembly to a drug device and needle ejection. Beginning with FIG. 6A, the needle assembly is first held within a sealed container 200, which includes a container body 210 and a cover 220. Next, as shown in FIG. 6B, the cover 220 is removed from the container body 210, exposing the needle assembly so that it may be coupled to a coupling end 550 of a first portion 502 of the drug device. In the exemplary embodiment of FIGS. 6A-6F, the first portion 502 of the drug device includes a drug container 530 and a drive spring 560, also shown in FIG. 5.

[0036] Next, as shown in Figure 6C, with the needle assembly held inside the container body 210 and hidden from view by the body 210, the container body is attached onto the coupling end 550 of the first part 502 of the drug device by pressing the container body 210 onto the coupling end 550. During this process, the needle assembly within the container body 210 is coupled to the coupling end 550 of the first part 502 of the drug device.

[0037] As shown in FIG. 6D , the container body 210 is removed from the needle assembly 100, leaving the needle assembly 100 coupled to the first portion 502 of the drug device. In this exemplary embodiment, the container body 210 can be used as a tool to couple the needle assembly to the drug device by pressing the container body 210 straight onto the drug device, as further discussed in connection with FIG. 8A . The container body 210 is then removed from the needle assembly 100 by pulling the container body 210 straight away from the drug device and needle assembly. In some embodiments, no relative twisting is required between the container body and the needle assembly and / or drug device to couple the needle assembly to the drug device and / or remove the container body from the needle assembly. However, in other embodiments, a relative twisting motion can be used.

[0038] 6E, needle assembly 100 can be seen with the container body removed. Needle assembly 100 includes carrier 20 and trigger 30 attached to the end of carrier 20. Needle assembly 100 also includes needle 10, at least a portion of which is positioned within carrier 20. At least a portion of the needle may be positioned within bore 31 of trigger 30. Initially, the needle is in a retracted position in which distal end 14 of the needle does not protrude beyond distal end 34 of trigger 30.

[0039] To actuate needle ejection, a force is applied proximally to trigger 30, as represented by the arrow shown in FIG. 6E. This force may be created, for example, by pressing trigger 30 firmly against the subject's skin. Pressing this trigger actuates needle 10 to move distally to the ejection position, as shown in FIG. 6F. In the ejection position, distal end 14 of needle 10 has moved out of trigger bore 31 and is instead positioned distal to distal end 34 of trigger 30.

[0040] 7A and 7B illustrate the removal of the needle assembly from the drug device. As shown in FIG. 7A, with the needle 10 still in the extended position, the user moves the container body 210 toward the needle assembly until the needle assembly is received within the container body 210. To unlock the needle assembly from the drug device, the user twists the container body 210 in either direction relative to the drug device. The user then pulls the container body 210 straight and away from the drug device to remove the needle assembly from the drug device.

[0041] A detailed view of the binding end of the drug device and the carrier of the needle assembly is shown in FIG. 8A, with the carrier shown in perspective. The carrier 20 includes a pawl 22 that interacts with the binding end 550 of the drug device. When the carrier 20 is pressed axially onto the binding end 550, the pawl 22 moves into an on-ramp 552 of the binding end 550, and the pawl 22 passes over a snap edge 556 and snaps into a recess 557, locking the carrier 20 onto the drug device. The recess is defined in the side wall of the device and has a distal boundary defined by the snap edge 556, a proximal boundary defined by the device body, and a pair of circumferential boundaries defined by the bump 524. The wall thickness of the binding end varies such that there is only clearance for the pawl 22 to enter the on-ramp and thus into the binding configuration at a specific angular orientation.

[0042] If, upon initial positioning of the carrier on the drug device, the carrier is not in the correct rotational orientation relative to the drug device, the pawl 22 can be guided by the protruding surface 553 of the on-ramp 552 to rotate the carrier toward an aligned position relative to the drug device. Surface 553 is shown in a tapered arrangement. The pawl flank 26 of the pawl 22 can slide against surface 553 of the on-ramp 552 during attachment of the carrier 20 to the coupling end 550. Surface 553 can function as a funnel that defines a narrowing width of the on-ramp in a direction toward the snap edge 556 and recess 557.

[0043] 8B shows the carrier 20 coupled to the drug device. The pawls 22 snap over the snap edges 556 into the recesses 557, rotatably and axially locking the carrier 20 to the drug device.

[0044] 9A-9C show a carrier in the process of being detached from a first portion of a drug device. As shown in FIG. 9A, the parts twist relative to one another to detach the carrier 20 from the first portion 502 of the drug device. The carrier pawls 22 first climb the detachment bumps 524 on the drug device. As the carrier pawls 22 slide against the detachment bumps, a detent is felt. The pawls 22 then encounter and enter the off-ramp 554 of the drug device. Continuing relative twisting causes the carrier pawls to slide along the helical surface 525 of the off-ramp (FIG. 9B), thereby separating the carrier from the drug device (FIG. 9C). The radial height of the off-ramp 554 may be greater than the height of the on-ramp.

[0045] Detailed views of the carrier are provided in Figures 11A-11F. Detailed views of the first portion of the drug device and its binding end are provided in Figures 12A-12E.

[0046] The operation of the drug delivery device will now be described with a series of cross-sectional views. Figures 10A-10C show cross-sectional views of a needle assembly coupled to a first portion of the drug delivery device. As shown in Figure 10A, the needle assembly, including the carrier 20, trigger 30, needle hub 40, and needle 10, is initially housed within a container body 210. The carrier 20 includes fins 23 that are received within recesses 213 in the container body 210. The carrier also includes an axial guide rib 21 with a radial tip 25 that initially holds the needle hub 40 prior to use.

[0047] 10B, the carrier 20 is pressed onto the first portion 502 of the drug device, and the carrier is engaged and aligned with the first portion 502 of the drug device. At this stage, when the needle carrier 20 is not yet fully engaged with the drug device, the needle 10 has not yet entered the septum 520 of the drug device.

[0048] As shown in FIG. 10C , when the needle carrier 20 is further pushed onto the drug device into a fully engaged position, the proximal end 12 of the needle 10 penetrates the septum 520 of the drug device. As shown in the enlarged view of FIG. 10C , the trigger 30 includes ribs 35 that interact with the legs 41 of the hub 40, as discussed below. When the carrier 20 engages the drug device, a drive spring 560 located on the drug device is axially compressed against the trigger 30, also referred to as spring-loading. The spring 560 remains compressed in order for the carrier 20 to engage the drug device and for the needle hub to initially lock onto the carrier. As shown in the enlarged view of FIG. 10C , the legs 41 are engaged with the carrier's shelves 29. More specifically, each of the legs 41 includes a notched region 41 a defined by a radial portion 41 b extending outward from an axial leg portion 41 c. Thus, a catch surface 41 d is formed that engages the outer surface 29 a of the shelf 29. Accordingly, outer surface 29a is sized to fit within notch 41a to facilitate orientation prior to deployment. It should be appreciated that in some embodiments, engagement of carrier 20 to the medication device does not require loading of drive spring 560.

[0049] Next, FIG. 10D shows that the trigger 30 of the drug delivery device is pressed against the skin 5 of the subject. As a result, the trigger 30 moves proximally toward the needle carrier 20. As shown in the enlarged view of FIG. 10D , moving the trigger proximally causes the contact surface 36 of the trigger rib 35 to contact and press against the hub legs 41 of the needle hub 40, thus moving the hub legs 41 radially inward until they pass the inner surface of the rib 35 and are released from the ledge 29 of the carrier 20, thus releasing the needle hub 40 to become movable relative to the carrier 20. As shown in FIG. 10E , with the needle hub 40 free to move distally relative to the carrier 20, the spring 560 that was exerting a force against the needle hub is free to expand axially, releasing its stored potential energy and pushing the needle hub 40 to move distally relative to the carrier. The needle 10 attached to the needle hub 40 moves distally with the needle hub into an ejection position where the distal end 14 of the needle 10 moves through the bore 31 of the trigger 30 and penetrates the skin 5 of the subject.

[0050] As shown in the enlarged view of Figure 10E, in some embodiments, distal movement of the needle hub causes needle hub legs 41 to move toward radial recesses 33 on the interior of trigger 30, locking hub 40 to trigger 30. In some embodiments, once the needle hub is locked in place, the needle cannot be redeployed.

[0051] Detailed views of the needle hub are provided in Figures 13A-13E, and detailed views of the trigger are provided in Figures 14A-14F.

[0052] 10F shows the container body 210 being used to remove the needle assembly 100 from the medication device. The container body 210 can serve as a sharps guard to help prevent the needle from being inadvertently touched.

[0053] 11A-11F show various views of a needle carrier 20 according to one exemplary embodiment. Fins 23 received by recesses in the container body are visible in the perspective views of FIGS. 11A and 11B, as well as in the end views of FIGS. 11C and 11D and the side view of FIG. 11E. Guide ribs 21 are visible in the cross-sectional view of FIG. 11F, and pawls 22 are visible in FIGS. 11B, 11D, and 11F. As shown in this embodiment, the needle carrier 20 includes a generally cup-shaped, cylindrical carrier body 230 defining a cavity 232 therein. The carrier body 230 includes a head portion 234 having a reduced cross-sectional area relative to the body portion 236. Fins 23 are shown projecting axially along and radially outward from the body portion 236. Pawls 22 are formed at the ends of pawl arms 22a along the body portion 236. The head portion 234 is configured to receive a trigger 30 (not shown) shaped to fit over the head portion 234. The head portion 234 includes axial slots that receive guide ribs. A first axial slot 242 is configured to receive a support rib 244. A second axial slot 238 is configured to receive a trigger guide rib 35. The head portion defines a longitudinal bore 240 projecting therein. The guide rib 21 may be defined as a continuous surface defining the bore, such as at the proximal end of the guide rib 21, with the radial tip 25 projecting into the body portion cavity 232. A bore 237 is formed in an end wall 239 of the head portion 234.

[0054] 12A-12E show various views of first portion 502 of the drug device, according to one exemplary embodiment. Binding end 550 is visible in the perspective view of FIG. 12A and the side view of FIG. 12D. Binding end 550 includes on-ramps 552 bounded by protruding sides 553 and off-ramps 554, each having a helical surface 525. Binding end 550 also includes snap edges 556 and recesses 557, as well as detachment bumps 524.

[0055] 13A-13E show various views of a needle hub 40 according to one exemplary embodiment. The needle hub 40 includes multiple legs 41 that can move radially inward and outward. The hub also includes slots 45 configured to receive guide ribs 21 from the carrier 20. The hub 40 also includes a bore 43 in which the needle is positioned. The needle may be secured to the hub in any suitable manner, for example, via adhesive, insert molding, mechanical interlocking, welding, integrally formed with the needle, UV light-activated adhesive, or any other suitable arrangement. The hub 40 may have a generally cup-shaped body 50 having an axial end wall 52, with a cylindrical side wall 54 projecting from the end wall. The legs 41 are formed along the side wall. In one embodiment, there are three circumferentially spaced legs. The legs 41 may be integrally formed with the side wall 54 and cantilevered, attached thereto to allow the legs 41 to flex. A central axial body 56 is shown projecting distally from end wall 52 and includes bore 43. Slot 45 is shown formed in end wall 52 and having a first portion 57 projecting radially outward from central body 56 and a second portion 58 projecting axially along side wall 54.

[0056] 14A-14F show various views of a trigger 30 according to one exemplary embodiment. The trigger includes ribs 35 having contact surfaces 36 for pushing the legs of the needle hub radially inward to release the needle hub for needle ejection, as described above. Also, as described above, recesses 33 distal to the ribs receive the legs of the needle hub after needle ejection, locking the needle hub in place and preventing subsequent needle deployment. The trigger 30 includes a cup-shaped body 60 with an axial end wall 62 and a cylindrical side wall 64 shaped to define a trigger cavity 66 for receiving the head portion 234 of the carrier body 230. The ribs 35 are axially disposed along the inner surface of the side wall and are circumferentially spaced apart from one another. Support ribs 244 are axially disposed along the inner surface between the ribs 35 and are circumferentially spaced apart from one another. A bore 31 is formed in the end wall 62.

[0057] 15A-15F show various views of a container body 210 according to one exemplary embodiment. The container body includes a recess 213 that receives the fins 23 of the needle carrier to couple the container body to the needle assembly. The body 210 is generally cup-shaped with an axial end wall 214 and a side wall 215 projecting from the end wall 214 to define a container cavity 216 sized and shaped to receive the carrier 20. A radial flange 217 projects from the proximal end of the side wall 215 and may be sized to provide a large contact surface for the cover seal. The recess 213 is defined along the inner surface of the side wall. The end wall 214 may be generally hemispherical.

[0058] According to one aspect, the drug delivery device can be configured so that the needle of the device remains hidden from the subject throughout all operational steps of the device. For example, the needle can remain hidden during attachment of the needle assembly to the drug device and during detachment of the needle assembly from the drug device. The drug delivery device can include a deployment mechanism that moves the needle from a retracted position to an extended position to penetrate the subject and enable delivery of the drug to the subject, and a retraction mechanism that retracts the needle after injection of the drug.

[0059] 16A-16H show a series of schematic diagrams of a drug delivery device according to one embodiment going through a series of operational steps. As shown in FIG. 16A, the drug delivery device may include a needle assembly 1000 and a drug device 1500. The drug device may include a first portion 1502 that houses a drug container and a second portion 1504 that includes an actuator 1590 and actuation configuration that helps release the drug from the drug container for injection into a subject.

[0060] The first portion 1502 of the drug device may include a coupling end 1550 for coupling to the needle assembly 1000. Figure 16B illustrates a process of coupling the needle carrier 1120 of the needle assembly 1000 to the drug device. As discussed in more detail below, in some embodiments, to couple the carrier to the drug device, the user presses the carrier against the drug device, rotates the carrier relative to the drug device, and then presses the carrier further back into the drug device.

[0061] 16C, the drug delivery device is set for injection by retracting actuator 1590. It should be understood that many different types of actuation mechanisms can be integrated into the drug delivery device, and those shown in the exemplary embodiments provided are not intended to be limiting of the drug delivery device.

[0062] The drug delivery device is then placed flush against the subject's skin with the needle carrier 1120 in contact with the skin 5, as shown in FIG. 16D.

[0063] The drug delivery device is now ready to be actuated to inject the medication into the subject. In some embodiments, actuation of the device actuator 1590 can cause multiple actions, for example, by pushing the actuator distally. First, as shown in FIG. 16E, depressing the actuator 1590 can cause the needle 1010 to protrude from the needle carrier 1120 and pierce the skin 5. Next, the device can allow the medication to be released from the medication container, through the needle, and into the subject. Finally, as shown in FIG. 16G, the device can retract the needle into the needle carrier 1120. As a result, when the drug delivery device is removed from the subject's skin with the needle retracted inside the needle carrier, the needle is no longer external to the device, helping to prevent inadvertent contact with the needle and allowing the subject to avoid encountering the needle.

[0064] Finally, as shown in FIG. 16H, the needle assembly may be removed from the drug device 1500 by pulling the needle carrier 1120 distally away from the drug device.

[0065] An exploded view of an exemplary embodiment of a drug delivery device is shown in FIG. 17. The drug delivery device includes a needle assembly including a needle 1010, a carrier 1120, a needle hub 1040, and a cam 1050. In some embodiments, the carrier 1120 may initially house the other components of the needle assembly. In some embodiments, a proximal cover 1220 may be positioned at the proximal end of the carrier 1120, and a distal cover 1221 may be positioned at the distal end of the carrier 1120. In some embodiments, the proximal cover 1220 is removable from the needle carrier 1120 to expose the components within the carrier and allow coupling of the needle carrier to the drug device. In some embodiments, the proximal cover is a peelable seal. In some embodiments, the distal cover 1221 is not configured to be removed, but instead is configured to be penetrated by a needle. However, in other embodiments, the distal cover 1221 is configured to be removed.

[0066] The drug device side can include a first portion 1502 and a second portion 1504. The first portion 1502 can house the drug container. In some embodiments, the second portion 1504 can include a device actuator and can include an actuation mechanism that serves to trigger the release of the drug from the drug container. As shown in FIG. 17 , the drug device also includes a collar 1570, a drive spring 1560, a retraction trigger 1582, and an ejection trigger 1584. In some embodiments, the drive spring 1560 is a torsion spring.

[0067] As will be discussed in detail, in some embodiments, the needle assembly couples to the drug device via a carrier 1120 that physically interfaces with a coupling end 1550 of the drug device.

[0068] 18A-18G show the drug delivery device of FIG. 17 going through a series of steps including coupling the needle assembly to the drug device, needle extension, and needle retraction. Starting in FIG. 18A, the components of the needle assembly are first held within a needle carrier 1120, which is sealed via a proximal cover 1220 and a distal cover 1221. Next, as shown in FIG. 18B, the proximal cover 1220 is removed from the carrier 1120, exposing the other components of the needle assembly and preparing the carrier 1120 to be coupled to a coupling end 1550 of a first portion 1502 of the drug device. In the exemplary embodiment of FIGS. 18A-18G, the first portion 502 of the drug device includes a collar 1570 at the coupling end 1550 of the drug device.

[0069] In some embodiments, the collar 1570 is rotatable between a deactivated orientation, in which the needle carrier cannot be coupled to the collar, and an activated orientation, in which the needle carrier can be coupled to the collar. Figure 18B shows the collar in a deactivated state, in which the needle carrier 1120 is physically blocked from sliding onto the collar.

[0070] In Figure 18C, the collar 1570 has been rotated in the activation direction. The needle carrier can then be slid onto the collar 1570. The user first presses the carrier 1120 against the collar, then rotates the carrier relative to the collar, and finally presses the carrier further against the collar, resulting in the needle assembly being coupled to the drug device, as shown in Figures 18D and 18E. The needle carrier can be retained in the drug device via a detent, which will be discussed in more detail below.

[0071] 18F, the user actuates the medication device, actuating the ejection trigger 1584, which moves the needle 1010 from the retracted position to the ejection position, piercing the distal cover 1221 in the process. While both an ejection trigger and a retraction trigger are provided in this embodiment, it should be understood that the disclosure is not limited in this respect. Thus, in one embodiment, only an ejection trigger is provided. In another embodiment, only a retraction trigger is provided.

[0072] Following this, the retraction trigger 1582 is actuated, which moves the needle 1010 back to the retracted position within the carrier 1120 .

[0073] In some embodiments, the user may be able to remove the needle assembly from the drug device. As shown in FIG. 19, the needle carrier 1120 may be pulled straight out of the drug device to remove the needle assembly. In some embodiments, the needle assembly is configured to prevent a used needle assembly from being reattached to the drug device, as described in more detail below.

[0074] A series of cross-sectional views of the drug delivery device of Figure 17 as the device undergoes a series of operating steps are provided in Figures 20A-20F.

[0075] 20A shows the drug delivery device without the needle assembly yet coupled to the drug device. The needle assembly includes a needle carrier 1120, as well as a needle 1010 housed within the needle carrier 1120, a needle hub 1040, and a cam 1050. A distal cover 1221 is also located at the distal end of the needle carrier 1120. On the drug device side, the drug device includes a collar 1570 and a torsion spring 1560.

[0076] In FIG. 20A , the collar 1570 is shown in a deactivated state. In the deactivated state, the collar is in a rotational orientation relative to the needle carrier that prevents the needle carrier from sliding onto the collar. As seen in FIG. 20A , in the deactivated state, the collar arm 1571 is aligned with the needle carrier tab 1121. The presence of the collar arm 1571 physically interferes with the needle carrier tab 1121, thus preventing the needle carrier from moving onto the collar.

[0077] As shown in Figure 20B, the collar can be rotated relative to the needle carrier to an activated state in which slots 1572 on the collar are rotationally aligned with carrier tabs 1121, thus providing carrier clearance against the collar.

[0078] The spring 1560 is initially held in a wound state. In other words, prior to actuation of the drug delivery device, the spring 1560 stores its potential energy. With the collar in the position shown in FIG. 20B, the spring 1560 is held in its wound state by the presence of the ejection trigger 1584. As shown in the close-up view of FIG. 20B, the ejection trigger 1584 physically blocks the collar 1570 from rotating, which in turn prevents the spring 1560 from being able to unwind.

[0079] 20C shows the needle carrier 1120 pressed against the collar 1570 with the carrier tab 1121 received in the slot in the collar. In this initial engagement stage, the needle 1010 has not yet entered the septum 1520 of the medication container 1530.

[0080] After this initial engagement with the drug device, the needle carrier is rotated relative to the drug device and then pressed further onto the drug device, resulting in full engagement of the needle carrier with the drug device, as shown in FIG. 20D. At the full engagement stage, the proximal end 1012 of the needle 1010 penetrates the septum 1520 and enters the inside of the drug container 1530. As shown in the enlarged view of FIG. 20D, upon full engagement, the carrier 1120 and the first portion 1502 of the drug device are at contact area 1501. When the user presses the needle carrier against the injection site, the axial force between the needle carrier and the drug device is transferred to contact area 1501. Detailed views of the carrier are shown in FIGS. 28A-28F, and detailed views of the collar are shown in FIGS. 31A-31E.

[0081] Next, in preparation for injecting the medication into a subject, the drug delivery device is held against the skin 5 of the subject, with the distal cover 1221 at the end of the needle carrier being held in contact with the skin.

[0082] The user actuates the drug delivery device by pulling back on the ejection trigger 1584, moving the trigger proximally, which unwinds the torsion spring 1560, freeing the collar 1570 to rotate. The rotation of the collar rotates the cam 1050, causing the radial end 1052 of the arm 1041 to ride on the cam surface 1051, causing the needle hub 1040 to eject the needle 1010, moving it from the retracted position to the extended position, with the distal end 1014 of the needle 1010 penetrating through the distal cover 1221 and into the subject's skin 5, as shown in FIG. 20E.

[0083] At the needle ejection stage shown in Figure 20E, the torsion spring 1560 is still partially wound. The spring 1560 is prevented from further unwinding by the presence of the retraction trigger 1582. As shown in the close-up view of Figure 20E, the retraction trigger 1582 physically blocks the rotation of the collar 1570, which in turn inhibits further unwinding of the spring.

[0084] The retraction trigger 1582 is then released, pulling the retraction trigger proximally from the collar 1570 and allowing the collar to rotate freely to unwind the spring 1560. This further rotation of the collar drives the cam 1050 and needle hub 1040 to retract the needle. Releasing the retraction trigger can be achieved by any suitable arrangement. For example, the retraction trigger can be released when the device is pulled away from the user's skin. The retraction trigger can be released upon completion of the injection and a short delay following needle withdrawal. In one embodiment, the retraction trigger is automatically activated upon completion of the injection. A suitable delay after the injection is completed may be desired for complete administration and to avoid excessive "drooling" after the needle is withdrawn. Such a delay may be approximately 5 seconds before the needle is retracted. Such a delay may be automatic or may instruct the user to hold the device against the skin, and the release trigger is moved as the device is removed from the user's skin.

[0085] In some embodiments, the needle assembly can be removed from the drug device after injection of the medicament. As shown in FIGS. 21A and 21B, the needle carrier 1120 is withdrawn from the collar 1570 by pulling the carrier distally away from the collar. The carrier's tabs 1121 slide out of the collar's slots 1572, and the arms 1571 bend radially inward to allow removal of the carrier from the collar. The carrier is shown in FIG. 21B as being completely removed from the drug device. Here, the needle carrier 1120 is a multi-function component in that the carrier can be used to attach the needle assembly to the device, can remain with the needle assembly for operation of the device, can be used as a tool to remove the needle assembly from the device, and can contain the used needle assembly after use.

[0086] Figures 22A-25B show the rotational positions of the collar relative to the drug delivery device of the embodiment of Figure 17 as the drug delivery device undergoes a series of operating steps. The collar is shown in phantom to facilitate visualization of the components.

[0087] First, Figures 22A and 22B show two perspective views of the collar prior to use, when the collar is in a deactivated state. The collar is rotatably mounted to the housing 1503 of the first portion of the medication device. The collar includes first and second collar stops 1573 and 1575 that initially contact the housing 1503. As seen in Figure 22A, the first collar stop 1573 initially contacts the first housing stop 1509. As seen in Figure 22B, the second collar stop 1575 initially contacts the second housing stop 1505. Detailed views of the collar are shown in Figures 31A-31E, and detailed views of the housing are shown in Figures 32A-32D.

[0088] 23A and 23B show two perspective views of the collar after it has been rotated into the activated state, where the first collar stop 1573 is in contact with the ejection trigger 1584 and the second collar stop 1575 is in air. The contact between the first collar stop 1573 and the ejection trigger 1584 prevents the collar from rotating further and prevents the spring 1560 from unwinding.

[0089] Then, when the ejection trigger 1584 is released and pulled back proximally, the unwinding of the spring 1560 allows the collar to rotate until the second collar stop 1575 contacts the retraction trigger 1582, as shown in FIG. 24B. As shown in FIG. 24A, the first collar stop 1573 is in mid-air.

[0090] Then, when the retraction trigger 1582 is released and pulled back proximally, the unwinding of the spring 1560 allows the collars to rotate further until the first and second collars stop contacting the housing 1503 of the first portion of the drug device, as shown in Figures 25A and 25B.

[0091] Figures 26A-26C show the alignment of the cam and needle hub of the needle assembly as the drug delivery device undergoes a series of needle ejection steps. The carrier is shown in phantom to facilitate visualization of the components. Figure 26A shows the cam 1050 in an initial angular position prior to use of the drug delivery device. The cam may include a tab 1055 that initially aligns with the carrier tab 1121, allowing the carrier 1120 to be mated with the collar of the drug delivery device. The cam may include a detent 1056 received by the inner wall surface 1129 of the carrier 1120 to help maintain the position of the cam within the carrier prior to use. The cam may include teeth 1054 adjacent the arms 1041 of the needle hub 1040 to hold the hub in place during penetration of the septum with the proximal end of the needle. The cam may include an ejection cam surface 1051 (also referred to as an ejection helix 1051) that rides on the radial end 1052 of the arms 1041. The cam may also include a retracting cam surface (also referred to as a retracting helix 1053) defined by a radially inwardly protruding lip 1053a that also interacts with the radial end 1052 of the arm 1041 during cam rotation. Specifically, a first surface 1057 (see FIG. 30A) of the radial end 1052 rides along the protruding cam surface 1051 when the cam is rotating in one direction, and a second surface 1059 (see FIG. 30A) of the radial end 1052 rides along the retracting cam surface 1053 when the cam is rotating in the opposite direction. Detailed views of the hub are shown in FIGS. 30A-30D, and detailed views of the cam are shown in FIGS. 29A-29F.

[0092] Figure 26B shows the cam in an intermediate angular position when the ejection trigger is released and the collar rotates, also rotating the cam (shown in a counterclockwise direction). The rotation of the cam causes the cam's ejection helix 1051 to push against the hub's arm 1041, driving the hub 1040 distally and moving the needle 1010 to the ejected position shown in Figure 26C, where the cam is in its final angular position for needle ejection. In the ejected state, the hub 1040 is held between the cam's ejection helix 1051 and retraction helix 1053.

[0093] Figures 27A and 27B show the positioning of the needle carrier as the drug delivery device undergoes a series of needle retraction steps. Figure 27A shows the state of the cam as the retraction trigger is released, rotating the collar and causing the cam to rotate (still in a counterclockwise direction). The rotation of the cam pulls the retraction helix 1053 proximally against the arm 1041 of the hub 1040, thus moving the needle 1010 to the retracted position, as shown in Figure 27B. An internal radial lip 1053a is formed along the retraction helix 1053 that captures the end of the arm of the needle hub during retraction.

[0094] In this retracted state, a detent 1056 on the cam engages the carrier wall, preventing the cam from rotating. Additionally, in some embodiments, the cam tab 1055 is misaligned with the carrier tab 1121, which prohibits the carrier from being attached to the collar of the drug device. Such an arrangement can help prevent needle reuse.

[0095] 28A-28F show various views of a needle carrier 1120 according to one exemplary embodiment. The needle carrier 1120 includes a cylindrical body 1123. Tabs 1121 are formed on the inner wall of the body adjacent the ends, protruding along a portion of the axial length of the body 1123 and projecting radially inward. A central bore region 1124 extends along the central axis and serves to guide the hub, specifically the central rotation axis 1058 of the hub 1040 (see FIG. 30A). Radially inward-projecting posts 1125 attach the hub guide to the inner wall of the body. A load-bearing surface 1126 on each post supports the central bore 1062 of the cam 1050. Retention snaps hold the cam to the carrier 1120. A cam rotation detent 1128 (start of cam rotation) and a cam rotation snap 1129 (end of cam rotation) limit the range of rotational displacement of the cam.

[0096] 29A-29F show various views of a cam 1050 according to one exemplary embodiment. The cam 1050 includes a generally cylindrical body 1060 having formed thereon an extruding cam surface 1051 and a retracting cam surface 1053. Also formed on the body is a tab 1055. The body further includes a bearing wall 1061 from which extends a central bore 1062. As discussed above, the cam may include teeth 1054 (which in this embodiment protrude axially on the cylindrical body in the same direction as the cam surfaces), detents 1056 (provided on the outer cylindrical body at the apex of the retracting cam surface), extruding 1051, and retracting helix 1053.

[0097] 30A-30D show various views of a needle hub 1040 according to one exemplary embodiment. The hub can include arms 1041 that interact with the cams of the needle assembly during needle extension and retraction. As described above, the hub includes a central rotation axis 1058. The rotation axis 1058 can also include a bore 1043 through which the needles extend. The radially extending arms 1041 are sized to fit within the space 1127 formed in the central bore region 1124 of the needle carrier 1120. Each arm 1041 includes a radial end 1052 having a first surface 1057 and a second surface 1059. The first surface is configured to ride along the extension cam surface 1051 when the cam is rotating in one direction, and the second surface 1059 is configured to ride along the retraction cam surface 1053 when the cam is rotating in the opposite direction. The front surface 1061 is configured to help allow the needle to penetrate the septum. In this regard, surface 1061 functions as a load-bearing surface that transmits forces applied to the carrier when the carrier is inserted into first portion 1502 of the medication device.

[0098] 31A-31E show various views of a collar 1570 according to one exemplary embodiment. As seen in these figures, the collar has a generally cylindrical body 1580 formed with arms 1571 and slots 1572. The arms include abutment receiving surfaces 1581 that impede insertion of the needle carrier 1120 along the slots 1582 defined by the arms 1571. The arms also include ramps 1584 that allow the arms to flex radially inward (due to gaps 1583 between the arms and the body) to permit removal of the needle carrier. The slots 1572 may be configured to receive tabs on the needle carrier during insertion, as discussed above. The collar may include first and second collar stops 1573 and 1575 that interact with the housing of the drug device and with retraction and ejection triggers that indicate the end of travel. The collar may further include a dividing rib 1585 that engages a collar retention groove 1587 to retain the collar to the first portion 1502. Notches 1586 may be formed along the inner surface to secure the ends of the torsion springs.

[0099] 32A-32D show various views of the housing 1503 of the first portion 1502 of the drug device according to one exemplary embodiment. As discussed above, the housing 1503 may include a first housing stop 1509 and a second housing stop 1505 that interact with the collar during operation of the device. As seen in FIG. 32B, the housing may include a retraction trigger slot 1512 through which the retraction trigger can move, and an ejection trigger slot 1514 through which the ejection trigger can move. The housing may also include an alignment slot 1506 configured to receive a tab on the needle carrier during coupling of the needle carrier to the housing. A trigger slot 1590 may be formed in an interior wall of the housing. The distal end of the housing includes a collar retention groove 1587.

[0100] It should be understood that the drug device shown is exemplary, as the needle assemblies described herein can be adapted for use with variously configured drug devices, including differently configured pen-type drug injection devices, differently shaped injection devices, and infusion pump devices. The medication can be of any of the types that can be delivered by such drug delivery devices. The device shown is intended to be exemplary and not limiting, as the needle assemblies described can be used with other, differently configured devices.

[0101] By clarifying the use of the following and notifying the public: 、 , ...and <n> At least one of the following" or "< / n> 、 、... <n> , or at least one of these combinations," or "< / n> 、 , ... and / or <n>The phrase "is defined by applicant in its broadest sense and supersedes any other implied definition above or below unless expressly asserted to the contrary by applicant, and means one or more elements selected from the group including A, B... and N. In other words, this phrase means any combination of one or more of the elements A, B,... or N, including any one element alone or that one element in combination with one or more of the other elements, which may also include additional, unlisted elements.

[0102] While various embodiments have been described, it will be apparent to those skilled in the art that many more embodiments and implementations are possible. Accordingly, the embodiments described herein are examples and not the only possible embodiments and implementations. Furthermore, the advantages described above are not necessarily the only advantages, and it is not necessarily expected that all of the described advantages will be achieved in each embodiment.

[0103] Various aspects are described in this disclosure, including but not limited to the following aspects. 1. A drug delivery device comprising: a needle assembly including a needle carrier, a needle hub movable relative to the needle carrier, and a needle coupled to the needle hub; a drug device having a container with a septum disposed at the container end opening and a carrier drive element, wherein the needle carrier is coupleable to the drug device; and a deployment trigger configured to actuate the carrier drive element to move the needle hub distally from a retracted needle hub position to an ejected needle hub position and to move the needle distally relative to the septum from the retracted needle position to the ejected needle position. 2. The drug delivery device of aspect 1, further comprising a cup body configured to accommodate a needle carrier, a needle hub, and a needle, the cup body being removably coupled to the needle carrier. 3. A drug delivery device as described in aspect 2, wherein the cup body further includes a cover sealed against the cup body to house the needle carrier, needle hub, and needle in a sealed space before the needle carrier is coupled to the drug device. 4. A drug delivery device as described in aspect 2, wherein one of the cup body and the needle carrier includes a fin and the other includes a recess shaped to receive the fin during mating of the cup body to the needle carrier. 5. The drug delivery device of any one of aspects 1-4, wherein the carrier drive element includes an axially compressible spring, the needle carrier is removably coupleable to the drug device to load the spring, and a deployment trigger is coupled to a distal end of the needle carrier, and the deployment trigger is actuated by a force applied proximally to the deployment trigger to unload the spring. 6. The drug delivery device of aspect 5, wherein a spring is disposed between the needle hub and the drug device, the needle hub including leg portions positioned to set the deployment trigger in a pre-actuation configuration relative to the needle carrier in which the spring is loaded in an axially compressed configuration, and in response to actuation of the deployment trigger, the deployment trigger deflects the leg portions of the needle hub radially inward such that the needle hub moves distally when the spring is unloaded to its axially expanded configuration. 7. The drug delivery device of aspect 5, wherein the deployment trigger is disposed coaxially relative to the needle carrier and is axially movable relative to the needle carrier between a covered position and a trigger position, wherein in the trigger position, the distal end of the needle does not protrude beyond the distal end of the deployment trigger, and during movement to the trigger position, the deployment trigger engages a portion of the needle hub to unlock the needle hub from the retracted needle hub position, whereby the needle hub advances distally to the protruding needle hub position by unloading the spring such that the distal end of the needle protrudes distally beyond the opening in the deployment trigger. 8. The drug delivery device of any one of aspects 1 to 7, further comprising a cam disposed radially between the needle hub and the needle carrier in a coaxial relationship, the cam configured to rotate to drive the needle hub to perform at least one of moving the needle in an extension direction and moving the needle in a retraction direction. 9. The drug delivery device of embodiment 8, wherein the drug device includes a collar that is rotatable under the biasing force of a spring, and the cam is rotatably locked by the collar in response to the needle carrier being coupled to the collar. 10. The drug delivery device of aspect 9, wherein in response to rotation of the cam by a first amount, the cam slidably engages the needle hub to advance the needle in a protrusion direction, and in response to rotation of the cam by another amount, the cam slidably engages the needle hub to retract the needle in a retraction direction. 11. The drug delivery device of aspect 10, wherein the deployment trigger selectively engages the collar, and wherein disengagement of the deployment trigger from the collar facilitates rotation of the collar by a first amount. 12. The drug delivery device of aspect 11, further comprising a retraction trigger that selectively engages the collar, wherein disengagement of the retraction trigger from the collar following disengagement of the deployment trigger facilitates rotation of the collar by another amount. 13. The drug delivery device of any one of the preceding aspects, wherein moving the needle distally from the retracted needle position to the ejected needle position comprises moving the needle through a septum. 14. The drug delivery device of aspect 13, wherein the drug device includes an outer housing, and the septum remains stationary relative to the outer housing during movement of the needle through the septum. 15. The drug delivery device of aspect 13, wherein the septum remains stationary relative to the needle carrier during coupling of the needle carrier to the drug device where the needle penetrates the septum, and during movement of the needle through the septum to the ejected needle position. 16. The drug delivery device of any one of the preceding aspects, wherein the drug device further includes a piston and a drug container containing the drug, the piston being movable relative to the drug container to release the drug from the drug container. 17. A method comprising: providing a medication device having a container with a septum and a carrier drive element disposed at the container end opening; providing a needle assembly including a needle carrier, a needle hub movable relative to the needle carrier, and a needle coupled to the needle hub; and when the needle carrier is coupled to the medication device, actuating a deployment trigger to actuate the carrier drive element to move the needle hub distally from a retracted needle hub position to an extended needle hub position and to move the needle from the retracted needle position to the extended needle position relative to the septum. 18. The method of embodiment 17, further comprising: providing a cup body that houses a needle assembly, the needle assembly including a deployment trigger, the carrier drive element including a spring, and the needle assembly being removable from the cup body; attaching the cup body to the drug device to couple the needle carrier to the drug device, the cup body housing the needle assembly; detaching the cup body from the needle assembly and from the drug device, the needle being in a retracted needle position after piercing the septum; after activating the deployment trigger, attaching the cup body over the needle assembly while the needle assembly is coupled to the drug device; coupling the cup body to the needle assembly; and, with the needle assembly coupled to the cup body, moving the cup body away from the drug device to remove the needle assembly from the drug device. 19. The method of aspect 18, wherein the step of attaching the cup body over the needle assembly occurs while the needle is in the extended needle position. 20. The method of aspect 18, further comprising, prior to the step of moving the cup body away from the drug device, rotating the cup body relative to the drug device when the needle assembly is coupled to the cup body to unlock the needle assembly from the drug device. 21. The method of any one of aspects 17-20, wherein the deployment trigger is attached to the needle carrier and is movable relative to the needle carrier. 22. The method of embodiment 21, wherein in the retracted needle position, the distal end of the needle is flush with or proximal to the distal end of the deployment trigger. 23. The method of embodiment 21, wherein in the ejection needle position, the distal end of the needle is distal to the distal end of the deployment trigger. 24. The method of aspect 21, wherein the step of pressing the deployment trigger comprises pressing the deployment trigger against the skin of the subject. 25. The method of any one of aspects 17-24, further comprising moving the needle in a retracting direction after the needle is moved from the retracted needle position to the extended needle position. 26. The method of any one of aspects 17-25, wherein the medication device further comprises the step of holding a medication container and moving a piston relative to the medication container to release the medication from the medication container. 27. The method of embodiment 21, wherein the deployment trigger is moved axially from a covered position to a trigger position relative to the needle carrier by depressing the deployment trigger to release the spring load, wherein in the trigger position the distal end of the needle does not protrude beyond the distal end of the deployment trigger, and during movement to the trigger position the deployment trigger engages a portion of the needle hub to unlock the needle hub from the retracted needle hub position, and the needle hub is moved distally to the protruding needle hub position by releasing the spring load such that the distal end of the needle protrudes distally beyond the opening in the deployment trigger. 28. The method of any one of aspects 17-27, further comprising coupling a needle carrier to the medication device and loading the spring. 29. The method of aspect 28, wherein the step of coupling the needle carrier to the drug device includes penetrating the proximal end of the needle through a septum of a drug container in the drug device. 30. The method of embodiment 29, wherein moving the needle from the retracted needle position to the ejected needle position comprises moving the needle through and relative to a septum. 31. The method of any one of aspects 17-30, further comprising actuating a retraction trigger to move the needle in a retracted direction from an extended needle position. 32. A needle assembly for coupling to a medication device having a container with a spring and a septum containing a fluid, the needle assembly including: a needle carrier removably coupleable to the medication device to load the spring; a needle hub movable relative to the needle carrier; and a needle coupled to the needle hub, wherein coupling of the needle carrier to the medication device facilitates penetration of the septum of the medication device with the needle, and the needle hub is movable distally relative to the needle carrier to position the distal end of the needle to protrude beyond the needle carrier and the proximal end of the needle to reside within the septum in fluid communication with the fluid in the container. 33. The needle assembly of embodiment 32, further comprising a cup housing that houses the needle carrier, a deployment trigger, a needle hub, and the needle. 34. The needle assembly of any one of aspects 32-33, wherein the needle hub is disposed within and coaxial with the needle carrier. 35. The needle assembly of any one of aspects 32-34, wherein the deployment trigger is attached to the needle carrier and movable relative to the needle carrier. 36. The needle assembly of any one of aspects 32-35, wherein the deployment trigger is disposed coaxially relative to the needle carrier, the deployment trigger being axially movable relative to the needle carrier between a covered position and a trigger position, wherein in the trigger position the distal end of the needle does not protrude beyond the distal end of the deployment trigger, and during movement to the trigger position the deployment trigger engages a portion of the needle hub to unlock the needle hub from the retracted needle hub position, and the needle hub is advanced distally to the protruding needle hub position by releasing the spring load such that the distal end of the needle protrudes distally beyond the opening in the deployment trigger. 37. The needle assembly of any one of aspects 32-36, further comprising a rotatable cam mounted radially between the needle hub and the needle carrier in a coaxial relationship, wherein in response to rotation of the cam due to unloading of the spring, the needle hub advances distally to an ejected needle hub position such that the distal end of the needle protrudes distally beyond the opening in the needle carrier. 38. The needle assembly of embodiment 37, wherein in response to rotation of the cam due to further unloading of the spring, the needle hub advances proximally to a retracted needle hub position such that the distal end of the needle is within the needle carrier. 39. The needle assembly of any one of aspects 32-38, further comprising a deployment trigger configured to unload the spring to move the needle hub distally from the retracted needle hub position to the ejected needle hub position and to move the needle distally from the retracted needle position to the ejected needle position.< / n>

Claims

1. 1. A drug delivery device comprising: a needle assembly including a needle carrier, a needle hub movable relative to the needle carrier, and a needle coupled to the needle hub; a medication device having a container with a septum disposed at a container end opening and a carrier drive element, wherein the needle carrier is connectable to the medication device; a deployment trigger configured to actuate the carrier drive element to move the needle hub distally from a retracted needle hub position to an ejected needle hub position and to move the needle distally relative to a septum from a retracted needle position to an ejected needle position.

2. 10. The drug delivery device of claim 1, further comprising a cup body configured to accommodate the needle carrier, the needle hub, and the needle, the cup body being removably coupled to the needle carrier.

3. 3. The drug delivery device of claim 2, wherein the cup body further includes a cover that is sealed to the cup body to house the needle carrier, the needle hub, and the needle in a sealed space before the needle carrier is coupled to the drug device.

4. 3. The drug delivery device of claim 2, wherein one of the cup body and the needle carrier includes a fin and the other includes a recess shaped to receive the fin during mating of the cup body to the needle carrier.

5. 2. The drug delivery device of claim 1, wherein the carrier drive element includes an axially compressible spring, the needle carrier is removably coupleable to the drug device to load the spring, the deployment trigger is coupled to a distal end of the needle carrier, and the deployment trigger is actuated by a force applied proximally to the deployment trigger to unload the spring.

6. 6. The drug delivery device of claim 5, wherein the spring is disposed between the needle hub and the drug device, the needle hub including leg portions positioned to set the deployment trigger in a pre-actuation configuration relative to the needle carrier in which the spring is loaded in an axially compressed configuration, and in response to actuation of the deployment trigger, the deployment trigger deflects the leg portions of the needle hub radially inward such that the needle hub moves distally when the spring is unloaded to its axially expanded configuration.

7. the deployment trigger is coaxially disposed relative to the needle carrier, the deployment trigger being axially movable relative to the needle carrier between a covered position and a trigger position; In the trigger position, the distal end of the needle does not extend beyond the distal end of the deployment trigger; 6. The drug delivery device of claim 5, wherein during movement to the trigger position, the deployment trigger engages a portion of the needle hub to unlock the needle hub from the retracted needle hub position, whereby the needle hub advances distally to the ejected needle hub position by unloading the spring such that the distal end of the needle protrudes distally beyond an opening in the deployment trigger.

8. 2. The drug delivery device of claim 1, further comprising a cam disposed radially between the needle hub and the needle carrier in a coaxial relationship, the cam configured to rotate to drive the needle hub to move the needle in at least one of a protruding direction and a retracting direction.

9. 9. The drug delivery device of claim 8, wherein the drug device includes a collar that is rotatable under the biasing force of the spring, and the cam is rotatably locked by the collar in response to the needle carrier being coupled to the collar.

10. 10. The drug delivery device of claim 9, wherein in response to rotation of the cam by a first amount, the cam slidably engages the needle hub to advance the needle in the extension direction, and in response to rotation of the cam by another amount, the cam slidably engages the needle hub to retract the needle in the retraction direction.

11. 11. The drug delivery device of claim 10, wherein the deployment trigger selectively engages the collar, and disengagement of the deployment trigger from the collar facilitates the rotation of the collar by the first amount.

12. 12. The drug delivery device of claim 11, further comprising a retraction trigger that selectively engages the collar, wherein disengagement of the retraction trigger from the collar following the disengagement of the deployment trigger facilitates the rotation of the collar by the different amount.

13. 10. A drug delivery device according to any one of the preceding claims, wherein movement of the needle distally from the retracted needle position to the ejected needle position comprises movement of the needle through the septum.

14. 14. The drug delivery device of claim 13, wherein the drug device includes an outer housing, and the septum remains stationary relative to the outer housing during movement of the needle through the septum.

15. 14. The drug delivery device of claim 13, wherein the septum remains stationary relative to the needle carrier during coupling of the needle carrier to the drug device with the needle penetrating the septum and during movement of the needle through the septum to the ejected needle position.

16. 10. A drug delivery device according to any one of the preceding claims, wherein the drug device further comprises a drug container containing a piston and a drug, the piston being movable relative to the drug container to release the drug from the drug container.

17. providing a medication device having a container with a septum and a carrier drive element disposed at a container end opening; providing a needle assembly including a needle carrier, a needle hub movable relative to the needle carrier, and a needle coupled to the needle hub; and when the needle carrier is coupled to the medication device, actuating a deployment trigger to actuate the carrier drive element to move the needle hub distally from a retracted needle hub position to an ejected needle hub position and move the needle from a retracted needle position to an ejected needle position relative to the septum.

18. providing a cup body that houses the needle assembly, the needle assembly including the deployment trigger, the carrier drive element including a spring, and the needle assembly being removable from the cup body; attaching the cup body to the medication device and coupling the needle carrier to the medication device, the cup body housing a needle assembly; removing the cup body from the needle assembly and from the medication device, the needle being in the retracted needle position after penetrating the septum; after actuating the deployment trigger, while the needle assembly is coupled to the medication device, attaching the cup body over the needle assembly; coupling the cup body to the needle assembly; 18. The method of claim 17, further comprising: removing the needle assembly from the drug device by moving the cup body away from the drug device while the needle assembly is coupled to the cup body.

19. 20. The method of claim 18, wherein the step of mounting the cup body over the needle assembly occurs while the needle is in the extended needle position.

20. 20. The method of claim 18, further comprising the step of rotating the cup body relative to the drug device when the needle assembly is coupled to the cup body to unlock the needle assembly from the drug device before the step of moving the cup body away from the drug device.

21. The method of claim 17, wherein the deployment trigger is attached to the needle carrier and is movable relative to the needle carrier.

22. 22. The method of claim 21, wherein in the retracted needle position, the distal end of the needle is flush with or proximal to the distal end of the deployment trigger.

23. 22. The method of claim 21, wherein in the ejection needle position, the distal end of the needle is distal to the distal end of the deployment trigger.

24. 22. The method of claim 21, wherein pressing the deployment trigger comprises pressing the deployment trigger against the skin of a subject.

25. 18. The method of claim 17, further comprising the step of moving the needle in a retracting direction after the needle is moved from the retracted needle position to the ejected needle position.

26. the medication device holds a medication container; 18. The method of claim 17, further comprising moving a piston relative to the drug container to expel the drug from the drug container.

27. depressing the deployment trigger to unload the spring, thereby moving the deployment trigger axially from a covered position to a trigger position relative to the needle carrier; in the trigger position, the distal end of the needle does not protrude beyond the distal end of the deployment trigger; 22. The method of claim 21, wherein during movement to the trigger position, the deployment trigger engages a portion of the needle hub to unlock the needle hub from the retracted needle hub position, and the needle hub is moved distally to the ejected needle hub position by releasing the spring load such that the distal end of the needle extends distally beyond an opening in the deployment trigger.

28. 18. The method of claim 17, further comprising coupling the needle carrier to the medication device and loading the spring.

29. 30. The method of claim 28, wherein coupling the needle carrier to the medication device comprises penetrating the proximal end of the needle through a septum of a medication container in the medication device.

30. 30. The method of claim 29, wherein moving the needle from the retracted needle position to the ejected needle position comprises moving the needle through and relative to the septum.

31. 18. The method of claim 17, further comprising actuating a retraction trigger to move the needle in a retracted direction from the extended needle position.

32. 1. A needle assembly for coupling to a medication device having a reservoir with a spring and a septum containing a fluid, said needle assembly comprising: a needle carrier removably coupleable to the medication device so as to load the spring; a needle hub movable relative to the needle carrier; a needle coupled to the needle hub; A needle assembly wherein coupling of the needle carrier to the drug device facilitates penetration of the septum of the drug device with the needle, and the needle hub is movable distally relative to the needle carrier to position the distal end of the needle to protrude beyond the needle carrier and the proximal end of the needle to remain within the septum in fluid communication with the fluid in the container.

33. 33. The needle assembly of claim 32, further comprising a cup housing containing the needle carrier, the deployment trigger, the needle hub, and the needle.

34. 33. The needle assembly of claim 32, wherein the needle hub is disposed within and coaxial with the needle carrier.

35. The needle assembly of claim 32, wherein the deployment trigger is attached to the needle carrier and is movable relative to the needle carrier.

36. the deployment trigger is coaxially disposed relative to the needle carrier, the deployment trigger being axially movable relative to the needle carrier between a covered position and a trigger position; in the trigger position, the distal end of the needle does not protrude beyond the distal end of the deployment trigger; 33. The needle assembly of claim 32, wherein during movement to the trigger position, the deployment trigger engages a portion of the needle hub to unlock the needle hub from the retracted needle hub position, and the needle hub is advanced distally to the extended needle hub position by releasing the spring load such that the distal end of the needle protrudes distally beyond an opening in the deployment trigger.

37. 33. The needle assembly of claim 32, further comprising a rotatable cam radially mounted between the needle hub and the needle carrier in coaxial relationship, wherein in response to rotation of the cam by unloading the spring, the needle hub advances distally to an ejected needle hub position such that the distal end of the needle protrudes distally beyond the opening in the needle carrier.

38. 38. The needle assembly of claim 37, wherein in response to rotation of the cam due to further unloading of the spring, the needle hub advances proximally to a retracted needle hub position such that the distal end of the needle is within the needle carrier.

39. 33. The needle assembly of claim 32, further comprising a deployment trigger configured to unload the spring to move the needle hub distally from a retracted needle hub position to an ejected needle hub position and move the needle distally from a retracted needle position to an ejected needle position.

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